Avelox 400mg/250ml Solution for Infusion

  • Name:

    Avelox 400mg/250ml Solution for Infusion

  • Company:
    info
  • Active Ingredients:

    Moxifloxacin hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/06/19

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Summary of Product Characteristics last updated on medicines.ie: 13/6/2019

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Bayer Limited

Bayer Limited

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13 June 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 June 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

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Update to PL due to outcome of art. 31 referral procedure from the EMA

Updated on 20 May 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 17 May 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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Dysglycemia

As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with moxifloxacin (see section 4.8). In moxifloxacin-treated patients, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g. sulfonylurea) or with insulin. Cases of hypoglycaemic coma have been reported. In diabetic patients, careful monitoring of blood glucose is recommended.

Updated on 20 December 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to other sources of information section

Updated on 18 December 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 18 December 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 11 December 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 11 December 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 15 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 15 June 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 -wording in the section has changed slightly as per the below, crossed out text has been removed and bold text has been added

Hypersensitivity/allergic reactions

Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration. Anaphylactic reactions can progress to a life-threatening shock, even after the first administration. In these cases of clinical manifestations of severe hypersensitivity reactions moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.

 

Peripheral neuropathy

Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving quinolones including moxifloxacin. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of an irreversible condition (see section 4.8).

 

 



 

Section 4.8
Vasculitis has been added as a very rare side effect.

Updated on 8 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 June 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 30 June 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Avelox Infusion (glass bottles) – 1410/27/3
www.medicines.ie

(Inserted Text; Deleted Text)

 

4.4          Special warnings and precautions for use

Dysglycemia

As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with moxifloxacin. In moxifloxacin-treated patients, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g. sulfonylurea) or with insulin. In diabetic patients, careful monitoring of blood glucose is recommended (see section 4.8).

 

 

4.8          Undesirable effects

Metabolism and nutrition disorders

 

Hyperlipidemia

Hyperglycemia

Hyperuricemia

Hypoglycemia

 

10.          DATE OF REVISION OF THE TEXT

 

December 2014 June 2015

 

 

Updated on 30 June 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 23 December 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

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2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

1 bottle of 250 ml contains 400 mg moxifloxacin (as hydrochloride).

1 ml contains 1.6 mg moxifloxacin (as hydrochloride).

 

Excipient with known effect: 250 ml of solution for infusion contains 787 mg (34 mmol) sodium.

 

For the full list of excipients, see section 6.1.

 

3.       PHARMACEUTICAL FORM

 

Solution for infusion

250 ml glass bottle or 250 ml polyolefine flexible bag filled with minimum 250 ml cClear, yellow solution.

 

4.6     Fertility, pregnancy and lactation

 

Breast-feeding

There is no data available in lactating or nursing women. Preclinical data indicate that small amounts of moxifloxacin are secreted in milk. In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature animals, breast-feeding is contraindicated during moxifloxacin therapy (see section 4.3).

 

4.8       Undesirable effects

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

5.1     Pharmacodynamic properties

 

Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones, ATC code: J01MA14

 

Mode Mechanism of action

Moxifloxacin inhibits bacterial type II topoisomerases (DNA gyrase and topoisomerase IV) that are required for bacterial DNA replication, transcription and repair.

 

6.1     List of excipients

 

Sodium chloride

Hydrochloric acid 1 N (for pH-adjustment)

Sodium hydroxide solution 2 N (for pH-adjustment)

Water for injections

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 04 April 2003

Date of last renewal: 30 November 201308

 

 

10.     DATE OF REVISION OF THE TEXT

 

03/2012December 2014

 

Updated on 23 December 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 29 June 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

(Inserted text; Deleted text)

2.            QUALITATIVE AND QUANTITATIVE COMPOSITION

 

……………………

Excipient with known effect: 250 ml of solution for infusion contains 34 mmol sodium.

 

For a the full list of excipients, see section 6.1.

 

 

3.            PHARMACEUTICAL FORM

 

Solution for infusion

250 ml glass bottle filled with minimum 250 ml cClear, yellow solution.

 

 

4.2          Posology and method of administration

 

Posology

The recommended dose is 400 mg moxifloxacin, infused once daily.

……………………………..

Renal/hepatic impairment

No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).

There is insufficient data in patients with impaired liver function (see section 4.3).

 

Other special populations

No adjustment of dosage is required in the elderly and in patients with low bodyweight.

 

Children and adolescents Paediatric population

Moxifloxacin is contraindicated in children and growing adolescents. Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).

 

 

4.3          Contraindications

 

-               Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients listed in section 6.1.

 

 

4.4          Special warnings and precautions for use

………………………………

Moxifloxacin should be used with caution in patients with any condition pre-disposing to cardiac arrhythmias (e.g. acute myocardial ischaemia) because they may have an increased risk of developing ventricular arrhythmias (incl. torsade de pointes) and cardiac arrest. See also sections 4.3 and 4.5.
Moxifloxacin should be used with caution in patients who are taking medications that can reduce potassium levels. See also sections 4.3 and 4.5.
…………………………………..

Hypersensitivity/allergic reactions

………………………………….

Peripheral neuropathy

Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving quinolones including Moxifloxacin. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop (see section 4.8).

 

Psychiatric reactions

Psychiatric reactions may occur even after the first administration of quinolones, including moxifloxacin. In very rare cases depression or psychotic reactions have progressed to suicidal thoughts and self-injurious endangering behaviour such as suicide attempts (see section 4.8)……………………

……………………………….

Interference with biological tests

Moxifloxacin therapy may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth causing false negative results in samples taken from patients currently receiving moxifloxacin.

 

4.5          Interaction with other medicinal products and other forms of interaction

…………………………

Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels (e.g. loop and thiazide-type diuretics, laxatives and enemas [high doses], corticosteroids, amphotericin B) or medication that is associated with clinically significant bradycardia.

………………………….

In vitro studies with human cytochrome P450 enzymes supported these findings. Considering these results a metabolic interaction via cytochrome P450 enzymes is unlikely.

…………………………

 

4.6          Fertility, pPregnancy and lactation

……………………………..

Lactation Breastfeeding

There is no data available in lactating or nursing women. Preclinical data indicate that small amounts of moxifloxacin are secreted in milk. In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature animals, breast-feeding is contraindicated during moxifloxacin therapy (see section 4.3).

 

Fertility

Animal studies do not indicate impairment of fertility (see section 5.3).

 

4.8          Undesirable effects

 

Adverse reactions observed in clinical trials with moxifloxacin 400 mg daily administered by the intravenous or oral route (intravenous only, sequential [IV/oral] and oral administration) sorted by frequencies are listed below:

 

Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%.

 

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as:

-               common (³ 1/100 to < 1/10)

-               uncommon (³ 1/1,000 to < 1/100)

-               rare (³ 1/10,000 to < 1/1,000)

-               very rare (< 1/10,000)

 

System Organ Class

(MedDRA)

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1,000 to < 1/100

Rare

≥ 1/10,000 to < 1/1,000

Very Rare

< 1/10,000

Infections and infestations

Superinfections due to resistant bacteria or fungi e.g. oral and vaginal candidiasis

 

 

 

Blood and lymphatic system disorders

 

Anaemia

Leucopenia(s)

Neutropenia

Thrombocytopenia

Thrombocythemia

Blood eosinophilia

Prothrombin time prolonged/INR increased

 

Prothrombin level increased/INR decreased

Agranulocytosis

Immune system disorders

 

Allergic reaction (see section 4.4)

Anaphylaxis incl. very rarely life-threatening shock (see section 4.4)

Allergic oedema/ angiooedema (incl. laryngeal oedema, potentially life-threatening, see section 4.4)

 

Metabolism and nutrition disorders

 

Hyperlipidemia

Hyperglycemia

Hyperuricemia

 

Psychiatric disorders

 

Anxiety reactions

Psychomotor hyperactivity/ agitation

Emotional lability

Depression (in very rare cases potentially culminating in self-injurious endangering behaviour, such as suicidal ideations/ thoughts, or suicide attempts, see section 4.4)

Hallucination

Depersonalization

Psychotic reactions (potentially culminating in self- injurious endangering behaviour, such as suicidal ideations/ thoughts, or suicide attempts, see section 4.4)

Nervous system disorders

Headache

Dizziness

Par- and Dysaesthesia

Taste disorders (incl. ageusia in very rare cases)

Confusion and disorientation

Sleep disorders (predominantly insomnia)

Tremor

Vertigo

Somnolence

Hypoaesthesia

Smell disorders (incl. anosmia)

Abnormal dreams

Disturbed coordination (incl. gait disturbances, esp. due to dizziness or vertigo)

Seizures incl. grand mal convulsions (see section 4.4)

Disturbed attention

Speech disorders

Amnesia

Periphal neuropathy and polyneuropathy

Hyperaesthesia

Eye disorders

 

Visual disturbances incl. diplopia and blurred vision (especially in the course of CNS reactions, see section 4.4)

 

Transient loss of vision (especially in the course of CNS reactions, see sections 4.4 and 4.7)

Ear and labyrinth disorders

 

 

Tinnitus

Hearing impairment incl. deafness (usually reversible)

 

Cardiac disorders

QT prolongation in patients with hypokalaemia (see sections 4.3 and 4.4)

QT prolongation (see section 4.4)

Palpitations

Tachycardia

Atrial fibrillation

Angina pectoris

Ventricular tachyarrhythmias

Syncope (i.e., acute and short lasting loss of consciousness)

Unspecified arrhythmias

Torsade de Pointes (see section 4.4)

Cardiac arrest (see section 4.4)

Vascular disorders

 

Vasodilatation

Hypertension

Hypotension

 

Respiratory, thoracic and mediastinal disorders

 

Dyspnea (including asthmatic conditions)

 

 

Gastrointestinal disorders

Nausea

Vomiting

Gastrointestinal and abdominal pains

Diarrhoea

Decreased appetite and food intakeAnorexia

Constipation

Dyspepsia

Flatulence

Gastritis

Increased amylase

Dysphagia

Stomatitis

Antibiotic-associated colitis (incl. pseudo­membranous colitis, in very rare cases associated with life-threatening complications, see section 4.4)

 

Hepatobiliary disorders

Increase in transaminases

Hepatic impairment (incl. LDH increase)

Increased bilirubin

Increased gamma-glutamyl-transferase

Increase in blood alkaline phosphatase

Jaundice

Hepatitis (predominantly cholestatic)

Fulminant hepatitis potentially leading to life-threatening liver failure (incl. fatal cases, see section 4.4)

Skin and subcutaneous tissue disorders

 

Pruritus

Rash

Urticaria

Dry skin

 

Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening, see section 4.4)

Musculoskeletal and, connective tissue and bone disorders

 

Arthralgia

Myalgia

Tendonitis (see section 4.4)

Muscle cramp

Muscle twitching

Muscle weakness

Tendon rupture (see section 4.4)

Arthritis

Muscle rigidity

Exacerbation of symptoms of myasthenia gravis (see section 4.4)

Renal and urinary disorders

 

Dehydration

Renal impairment (incl. increase in BUN and creatinine)

Renal failure (see section 4.4)

 

General disorders and administration site conditions

Injection and infusion site reactions

Feeling unwell (predominantly asthenia or fatigue)

Painful conditions (incl. pain in back, chest, pelvic and extremities)

Sweating

Infusion site (thrombo-) phlebitis

Oedema

 

 

The following undesirable effects have a higher frequency category in the subgroup of IV treated patients with or without subsequent oral therapy:

Common:               Increased gamma-glutamyl-transferase

Uncommon:          Ventricular tachyarrhythmias, hypotension, oedema, antibiotic-associated colitis (incl. pseudomembranous colitis, in very rare cases associated with life-threatening complications, see section 4.4), seizures incl. grand mal convulsions (see section 4.4), hallucination, renal impairment (incl. increase in BUN and creatinine), renal failure (see section 4.4)

 

There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: hypernatraemia, hypercalcaemia, haemolytic anaemia, rhabdomyolysis, photosensitivity reactions, peripheral neuropathy (see section 4.4).

 

5.1          Pharmacodynamic properties

…………………………………….

Breakpoints

EUCAST clinical MIC and disk diffusion breakpoints for moxifloxacin (01.01.2012) (31.01.2006):

Organism

Susceptible

Resistant

Staphylococcus spp.

≤ 0.5 mg/l

³ 24 mm

> 1 mg/l

< 21 mm

S. pneumoniae

≤ 0.5 mg/l

³ 22 mm

> 0.5 mg/l

< 22 mm

Streptococcus Groups A, B, C, G

≤ 0.5 mg/l

³ 18 mm

> 1 mg/l

< 15 mm

H. influenzae

≤ 0.5 mg/l

³ 25 mm

> 0.5 mg/l

< 25 mm

H. influenzae and M. catarrhalis

≤ 0.5 mg/l

³ 23 mm

> 0.5 mg/l

< 23 mm

Enterobacteriaceae

≤ 0.5 mg/l

³ 20 mm

> 1 mg/l

< 17 mm

Non-species related breakpoints*

≤ 0.5 mg/l

> 1 mg/l

* Non-species related breakpoints have been determined mainly on the basis of pharmacokinetic/pharmacodynamic data and are independent of MIC distributions of specific species. They are for use only for species that have not been given a species-specific breakpoint and are not for use with species where interpretative criteria remain to be determined (Gram-negative anaerobes).

…………………………………

 

 

Commonly susceptible species

Aerobic Gram-positive micro-organisms

Staphylococcus aureus*+

Streptococcus agalactiae (Group B)

Streptococcus milleri group* (S. anginosus, S. constellatus and S. intermedius)

Streptococcus pneumoniae*

Streptococcus pyogenes* (Group A)

Streptococcus viridans group (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilus)

Aerobic Gram-negative micro-organisms

Acinetobacter baumanii

Haemophilus influenzae*

Legionella pneumophila

Klebsiella pneumoniae*#

Moraxella (Branhamella) catarrhalis*

Anaerobic micro-organisms

Prevotella spp.

“Other” micro-organisms

Chlamydophila (Chlamydia) pneumoniae*

Coxiella burnetii

Legionella pneumophila

Mycoplasma pneumoniae*

Species for which acquired resistance may be a problem

Aerobic Gram-positive micro-organisms

Enterococcus faecalis*

Enterococcus faecium*

Aerobic Gram-negative micro-organisms

Enterobacter cloacae*

Escherichia coli*#

Klebsiella oxytoca

Klebsiella pneumoniae*#

Proteus mirabilis*

Anaerobic micro-organisms

Bacteroides fragilis*

Inherently resistant organisms

Aerobic Gram-negative micro-organisms

Pseudomonas aeruginosa

*Activity has been satisfactorily demonstrated in clinical studies.

+Methicillin resistant S. aureus have a high probability of resistance to fluoroquinolones. Moxifloxacin resistance rate of > 50% have been reported for methicillin resistant S. aureus.

#ESBL-producing strains are commonly also resistant to fluoroquinolones.

 

 

5.2          Pharmacokinetic properties

…………………

Metabolism Biotransformation

………………………

 

 

 

 

Renal impairment

The pharmacokinetic properties of moxifloxacin are not significantly different in patients with renal impairment (including creatinine clearance > 20 ml/min/1.73 m2). As renal function decreases, concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of < 30 ml/min/1.73 m2).

 

Hepatic impairment

On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child Pugh A, B), it is not possible to determine whether there are any differences compared with healthy volunteers. Impaired liver function was associated with higher exposure to M1 in plasma, whereas exposure to parent drug was comparable to exposure in healthy volunteers. There is insufficient experience in the clinical use of moxifloxacin in patients with impaired liver function.

 

6.5          Nature and contents of container

 

Colourless glass bottles (type 2) with a chlorobutyl or bromobutyl rubber stopper as closure. The 250 ml bottle is available in packs of 1 bottle and in multipacks containing 5 bottles (5 packs of 1 bottles).

 

Not all pack sizes may be marketed.

 

10.          DATE OF REVISION OF THE TEXT

 

February 2012 May 2012

Updated on 18 June 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 29 February 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

{Deleted text; Inserted text}

 

4.3       Contraindications

 

-               Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.

-               Pregnancy and lactation (see section 4.6).

-               Children and growing adolescents Patients below 18 years of age.

-               Patients with a history of tendon disease/disorder related to quinolone treatment.

 

………………………

 

4.4       Special warnings and precautions for use

 

The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section.

 

Prolongation of QTc interval and potentially QTc-prolongation-related clinical conditions

………………………………………………

 

 

Tendon inflammation, tendon rupture

Tendon inflammation and rupture (especially Achilles tendon), sometimes bilateral, may occur with quinolone therapy including moxifloxacin, even within 48 hours of starting treatment and have been reported up to several months after discontinuation of therapy. The risk of tendinitis and tendon rupture is increased particularly in elderly patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue treatment with moxifloxacin, rest the affected limb(s) and consult their doctor immediately in order to initiate appropriate treatment (e.g. immobilisation) for the affected tendon (see sections 4.3 and 4.8). Tendon inflammation and rupture may occur even up to several months after discontinuing quinolone therapy including moxifloxacin.

 

…………………………………………………..

 

 

4.5          Interaction with other medicinal products and other forms of interaction

Interactions with medicinal products

An additive effect on QT interval prolongation of moxifloxacin and other medicinal products that may prolong the QTc interval cannot be excluded. This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes. Therefore, co-administration of moxifloxacin with any of the following medicinal products is contraindicated (see also section 4.3):

-           anti-arrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide)

-           anti-arrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide)

-           antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride)

-           tricyclic antidepressive agents

-           certain antimicrobial agents (saquinavir, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine)

-           certain antihistaminics (terfenadine, astemizole, mizolastine)

-           others (cisapride, vincamine IV, bepridil, diphemanil).

 

Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels or medication that is associated with clinically significant bradycardia.

……………………………………………………………..

 

 

 

The Date of Revision of the text (Section 10) has been updated to “February 2012”

Updated on 17 February 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 22 December 2011 PIL

Reasons for updating

  • Change to further information section

Updated on 15 July 2011 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company


Section 4.5 (Interaction with other medicinal products and other forms of interaction):  has been updated as follows:

 

BEFORE:

Interactions with medicinal products

An additive effect on QT interval of moxifloxacin and other medicinal products that may prolong the QTc interval cannot be excluded. This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes. Therefore co-administration of moxifloxacin with any of the following medicinal products is contraindicated (see also section 4.3):

-        antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide)

-        antiarrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide)

-        neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride)

-        tricyclic antidepressive agents

-        certain antimicrobial agents (sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine)

-        certain antihistaminics (terfenadine, astemizole, mizolastine)

-        others (cisapride, vincamine IV, bepridil, diphemanil).

 

Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels or medication that is associated with clinically significant bradycardia.”

 

AFTER

“Interactions with medicinal products

An additive effect on QT interval prolongation of moxifloxacin and other medicinal products that may prolong the QTc interval cannot be excluded. This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes. Therefore co-administration of moxifloxacin with any of the following medicinal products is contraindicated (see also section 4.3):

-        anti-arrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide)

-        anti-arrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide)

-        antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride)

-        tricyclic antidepressive agents

-        certain antimicrobial agents (sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine)

-        certain antihistaminics (terfenadine, astemizole, mizolastine)

-        others (cisapride, vincamine IV, bepridil, diphemanil).”

 

Section 4.9 (overdose): has been updated as follows:

 

BEFORE:

“No specific countermeasures after accidental overdose are recommended. General symptomatic therapy should be initiated. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Concomitant administration of charcoal with a dose of 400 mg oral or intravenous moxifloxacin will reduce systemic availability of the drug by more than 80% or 20% respectively. The use of charcoal early during absorption may be useful to prevent excessive increase in the systemic exposure to moxifloxacin in cases of oral overdose.”

 

AFTER:

 “No specific countermeasures after accidental overdose are recommended. In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Concomitant administration of charcoal with a dose of 400 mg oral or intravenous moxifloxacin will reduce systemic availability of the drug by more than 80% or 20% respectively. The use of charcoal early during absorption may be useful to prevent excessive increase in the systemic exposure to moxifloxacin in cases of oral overdose.”

 

 

In Section 10, the date of revision of the text has been changed from “March 2011” to “July 2011”.

 

 

 

Updated on 12 July 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 25 March 2011 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.4     Special precautions for storage

 

Do not refrigerate or freeze. Do not store below 15°C.

 

6.5       Nature and contents of container

 

Colourless glass bottles (type 2) with a chlorobutyl or bromobutyl rubber stopper as closure. The 250 ml bottle is available in packs of 1 and 5 bottles.

 

 

6.6     Special precautions for disposal and other handling

At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature. It is therefore recommended not to store the infusion solution in a refrigerator below 15°C.

 

 

10.     DATE OF REVISION OF THE TEXT

March 2011

Updated on 21 March 2011 PIL

Reasons for updating

  • Change to packaging
  • Change to storage instructions
  • Change to date of revision

Updated on 18 March 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Significant changes to section 4.4

4.4     Special warnings and precautions for use

 

Retired text

Newly approved

 

Moxifloxacin has been shown to prolong the QTc interval on the electrocardiogram in some patients. The magnitude of QT prolongation may increase with increasing plasma concentrations due to rapid intravenous infusion. Therefore, the duration of infusion should not be less than the recommended 60 minutes and the intravenous dose of 400 mg once a day should not be exceeded. For more details see below and refer to sections 4.3 and 4.5.

 

-        Treatment with moxifloxacin should be stopped if signs or symptoms that may be associated with cardiac arrhythmia occur during treatment, with or without ECG findings.
Moxifloxacin should be used with caution in patients with any condition pre-disposing to cardiac arrhythmias (e.g. acute myocardial ischaemia) because they may have an increased risk of developing ventricular arrhythmias (incl. torsade de pointes) and cardiac arrest. See also sections 4.3 and 4.5.
Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels. See also section 4.3.
Moxifloxacin should be used with caution in patients who are taking medications associated with clinically significant bradycardia. See also section 4.3.
Female patients and elderly patients may be more sensitive to the effects of QTc-prolonging medications such as moxifloxacin and therefore special caution is required.

-        Moxifloxacin solution for infusion is for intravenous administration only. Intra-arterial administration should be avoided since preclinical studies demonstrated peri-arterial tissue inflammation following infusion by this route.

-        Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration. Anaphylactic reactions can progress to a life-threatening shock, even after the first administration. In these cases moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.

-        Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin (see section 4.8). Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.

-        Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin (see section 4.8). Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.

-        Quinolones are known to trigger seizures. Use should be with caution in patients with CNS disorders which may predispose to seizures or lower the seizure threshold.

-         Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving quinolones. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop (see section 4.8).

-        Antibiotic associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis. Therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin. If AAD or AAC is suspected or confirmed, ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic measures should be initiated immediately. Furthermore, appropriate infection control measures should be undertaken to reduce the risk of transmission. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea.

-        Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to maintain adequate fluid intake, because dehydration may increase the risk of renal failure.

-        Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.

-        Tendon inflammation and rupture may occur with quinolone therapy including moxifloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue treatment with moxifloxacin and rest the affected limb(s).

-        Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones. Therefore, moxifloxacin should be used with caution in these patients.

-        If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see sections 4.7 and 4.8).

-        Quinolones have been shown to cause photosensitivity reactions in patients. However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity. Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight during treatment with moxifloxacin.

-        Clinical efficacy of moxifloxacin in the treatment of severe burn infections, fasciitis, major abscesses and diabetic foot infections with osteomyelitis has not been established.

-        This medicinal product contains 787 mg (approximately 34 mmol) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

-        Moxifloxacin therapy may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth causing false negative results.

-        Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be started (see section 5.1).

 

Prolongation of QTc interval and potentially QTc-prolongation-related clinical conditions

 

Moxifloxacin has been shown to prolong the QTc interval on the electrocardiogram in some patients. The magnitude of QT prolongation may increase with increasing plasma concentrations due to rapid intravenous infusion. Therefore, the duration of infusion should not be less than the recommended 60 minutes and the intravenous dose of 400 mg once a day should not be exceeded. For more details see below and refer to sections 4.3 and 4.5.

 

Treatment with moxifloxacin should be stopped if signs or symptoms that may be associated with cardiac arrhythmia occur during treatment, with or without ECG findings.
Moxifloxacin should be used with caution in patients with any condition pre-disposing to cardiac arrhythmias (e.g. acute myocardial ischaemia) because they may have an increased risk of developing ventricular arrhythmias (incl. torsade de pointes) and cardiac arrest. See also sections 4.3 and 4.5.
Moxifloxacin should be used with caution in patients who are taking medications that can reduce potassium levels. See also section 4.3.
Moxifloxacin should be used with caution in patients who are taking medications associated with clinically significant bradycardia. See also section 4.3.
Female patients and elderly patients may be more sensitive to the effects of QTc-prolonging medications such as moxifloxacin and therefore special caution is required.

 

Hypersensitivity / allergic reactions

Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration. Anaphylactic reactions can progress to a life-threatening shock, even after the first administration. In these cases moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.

 

Severe liver disorders

Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin (see section 4.8). Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.

 

Serious bullous skin reactions

Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin (see section 4.8). Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.

 

Patients predisposed to seizures

Quinolones are known to trigger seizures. Use should be with caution in patients with CNS disorders or in the presence of other risk factors which may predispose to seizures or lower the seizure threshold. In case of seizures, treatment with moxifloxacin should be discontinued and appropriate measures instituted.

 

Peripheral neuropathy

Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving quinolones. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop (see section 4.8).

 

Psychiatric reactions

Psychiatric reactions may occur even after the first administration of quinolones, including moxifloxacin. In very rare cases depression or psychotic reactions have progressed to suicidal thoughts and self-endangering behaviour such as suicide attempts (see section 4.8). In the event that the patient develops these reactions, moxifloxacin should be discontinued and appropriate measures instituted. Caution is recommended if moxifloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.

 

Antibiotic-associated diarrhoea incl. colitis

Antibiotic-associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis. Therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin. If AAD or AAC is suspected or confirmed, ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic measures should be initiated immediately. Furthermore, appropriate infection control measures should be undertaken to reduce the risk of transmission. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea.

 

Patients with myasthenia gravis

Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.

 

Tendon inflammation, tendon rupture

Tendon inflammation and rupture may occur with quinolone therapy including moxifloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue treatment with moxifloxacin, rest the affected limb(s) and consult their doctor immediately in order to initiate appropriate treatment (e.g. immobilisation) for the affected tendon. Tendon inflammation and rupture may occur even up to several months after discontinuing quinolone therapy including moxifloxacin.

 

Patients with renal impairment

Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to maintain adequate fluid intake, because dehydration may increase the risk of renal failure.

 

Vision disorders

If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see sections 4.7 and 4.8).

 

Prevention of photosensitivity reactions

Quinolones have been shown to cause photosensitivity reactions in patients. However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity. Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight during treatment with moxifloxacin.

 

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients with a family history of or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones. Therefore, moxifloxacin should be used with caution in these patients.

 

Peri-arterial tissue inflammation

Moxifloxacin solution for infusion is for intravenous administration only. Intra-arterial administration should be avoided since preclinical studies demonstrated peri-arterial tissue inflammation following infusion by this route.

 

Patients with special cSSSI

Clinical efficacy of moxifloxacin in the treatment of severe burn infections, fasciitis, major abscesses and diabetic foot infections with osteomyelitis has not been established.

 

Patients on sodium diet

This medicinal product contains 787 mg (approximately 34 mmol) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

 

Interference with biological tests

Moxifloxacin therapy may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth causing false negative results.

 

Patients with MRSA infections

Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be started (see section 5.1).

 

Paediatric population

Due to adverse effects on the cartilage in juvenile animals (see section 5.3) the use of moxifloxacin in children and adolescents < 18 years is contraindicated (see section 4.3).

 

 

 

4.5     Interaction with other medicinal products and other forms of interaction

 

Subheading: “Interactions with medicinal products”

 

An additive effect on QT interval of between moxifloxacin and other medicinal products that may prolong the QTc interval cannot be excluded.

 

 

Subheading: “Changes in INR

 

Clinical studies have shown no interactions following concomitant administration of moxifloxacin with: ranitidine, probenecid, oral contraceptives, calcium supplements, morphine administered parenterally, theophylline, cyclosporine or itraconazole.

 

 

4.8       Undesirable effects

 

Insertion of System organ class to table:

 

System Organ Class

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1,000 to < 1/100

Rare

≥ 1/10,000 to < 1/1,000

Very Rare

< 1/10,000

Vascular disorders

 

Vasodilatation

Hypertension

Hypotension

 

 

 

Addition of “muscle weakness” under organ class “Musculoskeletal, connective tissue and bone disorders” as a rare undesirable effect.

 

4.9     Overdose

Insertion of: ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.

 

 

10.     DATE OF REVISION OF THE TEXT

 

February 2011

Updated on 14 March 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 29 September 2010 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

10. DATE of REVISION of text

changed to “August 2010”

Updated on 17 September 2010 PIL

Reasons for updating

  • Change to date of revision

Updated on 23 June 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



Addition of the following to section 4.4:

 

Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving quinolones. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop (see section 4.8).

 

Section 4.7

Addition of “acute transient loss of vision” as an example of a potential CNS reaction.

However, fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (e.g. dizziness; acute, transient loss of vision, see section 4.8) or acute and short lasting loss of consciousness (syncope, see section 4.8).

 

Section 4.8

 

Addition of “Agranulocytosis” as a very rare adverse event observed.

 

In psychiatric disorders addition of “suicidal ideations/ thoughts, or suicide attempts” as example of self endangering behaviour under the category very rare adverse event observed.

 

Under eye disorders addition of “Transient loss of vision (especially in the course of CNS reactions, see sections 4.4 and 4.7)” as a very rarely observed adverse event.

 

Under ear and labyrinth disorders insertion of “Hearing impairment incl. deafness (usually reversible)” as a rarely observed adverse event.

 

Addition of “haemolytic anaemia” and “peripheral neuropathy” as side effects reported with other fluoroquinolones.

 

Section 7

“Bayer Healthcare AG” changed to “Bayer Schering Pharma AG”

 

Section 10

Changed to “May 2010”

Updated on 17 June 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to name of manufacturer

Updated on 1 February 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to marketing authorisation holder
  • Change to marketing authorisation holder address
  • Change to date of revision

Updated on 29 January 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4:

 Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with moxifloxacin (see section 4.8). Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.

 

'Pseudomembranous colitis has been reported in association with the use of broad spectrum antibiotics including moxifloxacin' has been replaced with the following text:

Antibiotic associated colitis (incl. pseudomembranous colitis) has been reported in association with the use of broad spectrum antibiotics including moxifloxacin.

 

Section 4.8:

 Headers and text updated to read as follows:

 

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1,000 to < 1/100

Rare

≥ 1/10,000 to < 1/1,000

Very Rare

≤ 1/10,000

 

Blood and Lymphatic System Disorders

 

Anaemia

Leucopenia(s)

Neutropenia

Thrombocytopenia

Thrombocythemia

Blood eosinophilia

Prothrombin time prolonged / INR increased

 

Prothrombin level increased / INR decreased

 

Psychiatric Disorders

 

Anxiety reactions

Psychomotor hyperactivity / agitation

Emotional lability

Depression (in very rare cases potentially culminating in self-endangering behaviour)

Hallucination

Depersonalization

Psychotic reactions (potentially culminating in self-endangering behaviour)

 

Cardiac and Vascular Disorders

QT prolongation in patients with hypokalaemia (see section 4.4)

QT prolongation (see section 4.4)

Palpitations

Tachycardia

Atrial fibrillation

Angina pectoris

Vasodilatation

Ventricular tachyarrhythmias

Syncope

Hypertension

Hypotension

Unspecified arrhythmias

Torsade de Pointes (see section 4.4)

Cardiac arrest (see section 4.4)

 

Gastrointestinal Disorders

Nausea

Vomiting

Gastrointestinal and abdominal pains

Diarrhoea

Anorexia

Constipation

Dyspepsia

Flatulence

Gastritis

Increased amylase

Dysphagia

Stomatitis

Antibiotic associated colitis (incl. pseudomembranous colitis, in very rare cases associated with life-threatening complications, see section 4.4)

 

 

Hepatobiliary Disorders

Increase in transaminases

Hepatic impairment (incl. LDH increase)

Increased bilirubin

Increased gamma-glutamyl-transferase

Increase in blood alkaline phosphatase

Jaundice

Hepatitis (predominantly cholestatic)

Fulminant hepatitis potentially leading to life-threatening liver failure (see section 4.4)

 

Skin and Subcutaneous Tissue Disorders

 

Pruritus

Rash

Urticaria

Dry skin

 

Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening)

 

General Disorders and Administration Site Conditions

Injection and infusion site reactions

Feeling unwell (predominantly asthenia or fatigue)

Painful conditions (incl. pain in back, chest, pelvic and extremities)

Sweating

Infusion site (thrombo-) phlebitis

Oedema

 

 

Uncommon:          Ventricular tachyarrhythmias, hypotension, oedema, antibiotic associated colitis (incl. pseudomembranous colitis, in very rare cases associated with life-threatening complications, see section 4.4).

 

 

Section 5.1:
Text now reads:

In vitro Susceptibility Data

Clinical and Laboratory Standards Institute¢â (CLSI) MIC and disc diffusion breakpoints for Staphylococcus spp. and fastidious organisms (M100-S17, 2007) and MIC breakpoints for anaerobes (M11-A7, 2007). (Aerobes M100-S16,2006 has been deleted).

 

Species for which acquired resistance may be a problem

Aerobic Gram-positive micro-organisms

Enterococcus faecalis*

Staphylococcus aureus (methicillin-resistant)+

Aerobic Gram-negative micro-organisms

Enterobacter cloacae

Escherichia coli*

Klebsiella oxytoca

 

Section 7

MA holder is now Bayer Limited, The Atrium, Blackthorn Avenue, Dublin 18.

 

Section 8:
MA number is now 1410/27/3

 

Section 10:
Date of revision of text is January 2008

Updated on 9 January 2007 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 (Special warnings and precautions for use:

Bullet point 2, paragraph 3 has been re-worded.

Bullet point 9, has been reworded.

Bullet point 10, has been reworded

 

Section 4.5 (Interaction with other medicinal products and other forms of interactions):

Paragraph 7 has been amended to read: “Clinical studies have shown that there are no interactions following …..”. 

 

Section 4.7 (Effects on ability to drive and use machines):

The wording has been amended slightly: “….. (e.g. dizziness, see section 4.8). 

 

Section 4.8 (Undesirable effects):

The table has been extensively revised to reflect MedDRA terminology.

 

Section 5.1 (Pharmacodynamic properties):

The wording has been updated in line with the Company Core Data Sheet.

 

Section 10 (Date of revision of the text):

This has been updated to ’26.07.2006’. 

 

Updated on 12 December 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 1 September 2006 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Avelox 400 mg solution for infusion is indicated for the treatment of:

·                    Community acquired pneumonia

·                    Complicated skin and skin structure infections (see section 4.4)

caused by bacteria susceptible to moxifloxacin in patients requiring initial parenteral therapy.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Updated on 14 September 2005 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 12 September 2005 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to, or new use for medicine
  • Change to how the medicine works
  • Change to date of revision

Updated on 3 August 2005 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 2 February 2005 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 1 February 2005 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 1 February 2005 PIL

Reasons for updating

  • Change to packaging
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 29 July 2004 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 December 2003 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)