Ciprofloxacin Mylan 2mg/1ml solution for infusion

  • Name:

    Ciprofloxacin Mylan 2mg/1ml solution for infusion

  • Company:
    info
  • Active Ingredients:

    Ciprofloxacin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/07/19

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Summary of Product Characteristics last updated on medicines.ie: 19/7/2019

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Gerard Laboratories

Gerard Laboratories

Company Products

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Medicine Name Agomelatine Mylan 25 mg film-coated tablets Active Ingredients Agomelatine
Medicine Name Amisulpride 50mg & 200mg Tablets Active Ingredients Amisulpride
Medicine Name Amlodipine Mylan 5mg & 10mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Areloger 7.5mg & 15mg Tablets Active Ingredients Meloxicam
Medicine Name Aripil 5mg & 10mg Film-coated Tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Atenetic 50/12.5mg & 100/25mg Film - coated Tablets Active Ingredients Atenolol, Chlortalidone
Medicine Name Atorvastatin Mylan 10 mg, 20 mg, 40 mg & 80 mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets Active Ingredients Atovaquone, Proguanil Hydrochloride
Medicine Name Azromax 250mg Film-coated tablets Active Ingredients Azithromycin monohydrate
Medicine Name Baclopar Tablets 10 mg Active Ingredients Baclofen
Medicine Name Bisoprolol Mylan Active Ingredients Bisoprolol Fumarate
Medicine Name Brabio 20mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Brabio 40mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Cifloxager 250 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Cifloxager 500 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Ciprager 10mg & 20mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprager 40mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprofloxacin Mylan 2mg/1ml solution for infusion Active Ingredients Ciprofloxacin
Medicine Name Clopidogrel Mylan 75 mg film-coated tablets Active Ingredients clopidogrel hydrochloride
Medicine Name Darunavir Mylan 800 mg film-coated tablets Active Ingredients darunavir ethanolate
Medicine Name Depreger 50mg & 100mg Film-Coated Tablets Active Ingredients sertraline hydrochloride
Medicine Name Diaclide MR 30 mg Modified-release Tablets Active Ingredients Gliclazide
Medicine Name Diaclide MR 60mg modified-released tablets Active Ingredients Gliclazide
1 - 0 of 116 items.Total: Infinity pages

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 19 July 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 19 July 2019 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 4.8 - 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)

Updated on 14 March 2019 PIL

Reasons for updating

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

Updated on 14 March 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 21 December 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 21 December 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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 16 May 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 23 April 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents

Updated on 18 January 2018 SmPC

Reasons for updating

  • Change to section 6.2 - Incompatibilities
  • 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

6.2 Incompatibilities

Ciprofloxacin Mylan cannot be mixed with solutions that are not stable at a pH of approximately 4.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Unless compatibility with other solutions/drugs has been confirmed, the infusion solution must always be administered separately. The visual signs of incompatibility are e.g. precipitation, clouding, and discoloration.

Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solutions (e.g. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of ciprofloxacin solutions: 3.5 – 4.6).

10. DATE OF REVISION OF THE TEXT

June 2016October 2017

Updated on 18 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 29 June 2016 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic 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

4.4 Special warnings and precautions for use

Paediatric population
The use of ciprofloxacin in children and adolescents should follow available official guidance.

Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.

Ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals.
Safety data from a randomised double-blind study on ciprofloxacin use in children (ciprofloxacin: n=335, mean age = 6.3 years; comparators: n=349, mean age = 6.2 years; age range = 1 to 17 years) revealed an incidence of suspected drug-related arthropathy (discerned from joint-related clinical signs and symptoms) by Day +42 of 7.2% and 4.6%. Respectively, an incidence of drug-related arthropathy by 1-year follow-up was 9.0% and 5.7%. The increase of suspected drug-related arthropathy cases over time was not statistically significant between groups. Treatment should be initiated only after a careful benefit/risk evaluation, due to possible adverse events related to joints and/or surrounding tissue (see section 4.8).

Cytochrome P450
Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine). Co-administration of ciprofloxacin and tizanidine is contra-indicated. Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e.g. of theophylline) may be necessary (see section 4.5).

4.5 Interaction with other medicinal products and other forms of interaction

Effects of ciprofloxacin on other medicinal products:

Agomelatine
In clinical studies, it was demonstrated that fluvoxamine, as a strong inhibitor of the CYP450 1A2 isoenzyme, markedly inhibits the metabolism of agomelatine resulting in a 60-fold increase of agomelatine exposure. Although no clinical data are available for a possible interaction with ciprofloxacin, a moderate inhibitor of CYP450 1A2, similar effects can be expected upon concomitant administration (see section 4.4).

Zolpidem
Co-administration ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended.

4.8 Undesirable effects

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

 

 

Frequency not known

(cannot be Estimated from available data)

Infections and Infestations

 

Mycotic superinfections

 

 

Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)

 

 

 

Blood and Lymphatic System Disorders

 

Eosinophilia

 

 

Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia

 

 

Haemolytic anaemia Agranulocy

tosis Pancytopenia (life-threatening) Bone marrow depression (life-threatening)

 

 

Immune System Disorders

 

Allergic reaction Allergic oedema / angiooedema

 

 

Anaphylactic reaction Anaphylactic shock (life-threatening) (see section 4.4)

Serum sickness-like reaction

 

 

Metabolism and Nutrition Disorders

 

Anorexia

 

 

Hyperglycaemia

Hypoglycaemia (see section 4.4)

 

 

Increased bilirubin

 

Hepatitis

 

progressing to life-threatening hepatic failure) (see section 4.4)

 

Skin and Subcutaneous Tissue Disorders

 

 

Rash

Pruritus Urticaria

 

Photosensitivity reactions (see section 4.4)

 

Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life-threatening) Toxic epidermal necrolysis (potentially life-threatening)

 

Acute generalised exanthematous pustulosis (AGEP)

,

 

DRESS

 

 

Musculoskeletal and Connective Tissue Disorders

 

 

Musculoskeletal pain (e.g. extremity pain, back pain, chest pain)

Arthralgia

 

Myalgia

Arthritis

Increased muscle tone and cramping

 

Muscular weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)

 

Renal and Urinary Disorders

 

 

Renal impairment

 

Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis

 

General Disorders and Administration Site Conditions

 

 

Injection and infusion site reactions (only intravenous administration)

 

Asthenia Fever

 

Oedema

Sweating (hyperhidrosis)

 

Investigations

 

 

Increase in blood alkaline phosphatase

 

Prothrombin level abnormal, Increased amylase

 

International normalised ratio increased (in patients treated with Vitamin K antagonists)

 



Psychiatric Disorders

 

Psychomotor hyperactivity / agitation

 

 

Confusion and disorientation Anxiety reaction Abnormal dreams Depression (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

Hallucinations

 

 

Psychotic reactions (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

 

 

Mania, hypomania

 

 

 

Nervous System Disorders

 

Headache Dizziness

Sleep disorders Taste disorders

 

 

Par- and Dysaesthesia Hypoaesthesia

Tremor

Seizures (incl. status epilepticus see section 4.4)

Vertigo

 

 

Migraine Disturbed coordination

Gait disturbance Olfactory nerve disorders Intracranial hypertension and pseudotumor cerebri

 

 

Peripheral neuropathy and polyneuropathy (see section 4.4)

 

 

Eye Disorders

 

Visual disturbances (e.g. diplopia)

 

 

Visual colour distortions

 

 

Ear and Labyrinth Disorders

 

Tinnitus

Hearing loss / Hearing impaired

 

 

Cardiac Disorders

 

Tachycardia

 

 

Ventricular arrhythmia, torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see sections 4.4 and 4.9).

 

 

Vascular Disorders

 

Vasodilatation Hypotension Syncope

 

 

Vasculitis

 

 

Respiratory, Thoracic and Mediastinal Disorders

 

Dyspnoea (including asthmatic condition)

 

 

Gastrointestinal Disorders

 

Nausea Diarrhoea

 

 

Vomiting Gastrointestinal and abdominal pains

Dyspepsia Flatulence

 

 

Antibiotic associated diarrhea incl. pseudomembraneous colitis (see section 4.4)

 

 

 

Pancreatitis

 

 

Hepatobiliary Disorders

 

Increase in transaminases

 

 

Hepatic impairment Cholestatic icterus

 

 

Liver necrosis (very rarely

 

 



4.9 Overdose

Symptoms
An overdose of 12 g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16 g has been reported to cause acute renal failure.
Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria.
Reversible renal toxicity has been reported.

Management
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Apart from routine emergency measures e.g. ventricular emptying followed by medical carbon, it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria. Calcium or magnesium containing antacids may theoretically reduce the absorption of ciprofloxacin in overdoses.
Patients should be kept well hydrated.
Only a small quantity of ciprofloxacin (<10%) is eliminated by haemodialysis or peritoneal dialysis.

5.2 Pharmacokinetic properties

Metabolism Biotransformation
Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4). The metabolites display in-vitro antimicrobial activity but to a lower degree than the parent compound.

Paediatric patients populations
The pharmacokinetic data in paediatric patients are limited.

In a study in children Cmax and AUC were not age-dependent (above one year of age). No notable increase in Cmax and AUC upon multiple dosing (10 mg/kg three times daily) was observed.

In 10 children with severe sepsis Cmax was 6.1 mg/L (range 4.6-8.3 mg/L) after a 1-hour intravenous infusion of 10 mg/kg in children aged less than 1 year compared to 7.2 mg/L (range 4.7-11.8 mg/L) for children between 1 and 5 years of age. The AUC values were 17.4 mg*h/L (range 11.8-32.0 mg*h/L) and 16.5 mg*h/L (range 11.0-23.8 mg*h/L) in the respective age groups.

These values are within the range reported for adults at therapeutic doses. Based on population pharmacokinetic analysis of paediatric patients with various infections, the predicted mean half-life in children is approx. 4-5 hours and the bioavailability of the oral suspension ranges from 50 to 80%.

Updated on 28 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 June 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration

Updated on 6 October 2015 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 4.6 - Pregnancy and lactation
  • 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

Urinary tract infections

Resistance to fluoroquinolones of

 

 

Escherichia coli - the most common pathogen involved in urinary

 

tract infections - varies across the European Union. Prescribers are advised to take into account the

local prevalence of resistance in

 

 

Escherichia coli to fluoroquinolones.

 


Children and adolescentsPaediatric population

The use of ciprofloxacin in children and adolescents should follow available official guidance.

 

Hypoglycaemia

 

 

 

 

As with other quinolones, hypoglycaemia has been reported most often in diabetic patients,

predominantly in the older population. In all diabetic patients, careful monitoring of blood glucose is

recommended

 

 

.

Section 4.5

 

Metoclopramide

 

 

 

Metoclopramide accelerates the absorption of ciprofloxacin (oral) resulting in a shorter time to reach

maximum plasma concentrations. No effect was seen on the bioavailability of ciprofloxacin.

 

 

 

Omeprazole

 

 

 

Concomitant administration of ciprofloxacin and omeprazole containing medicinal products results in

a slight reduction of C

 

 

max and AUC of ciprofloxacin.

 

 

 

 

Section 4.6
Breast-feeding

Section 4.8
Metabolism and Nutrition Disorders

 

 

 

Rare HyperglycaemiaHypoglycaemia (see section 4.4)

 

Nervous System Disorder

 

 

 

 

Very Rare: Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension and pseudo tumorcerebri

 

Frequency not known

 

 

Peripheral neuropathy and poly neuropathy

 

 

 





 

Updated on 6 October 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 13 January 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

The following text is added to section 4.4
Vision Disorders
If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see section 4.8)

Reporting side effects details update to include name change from IMB to HPRA

Updated on 13 January 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 21 May 2014 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Section 2 - 200 mg bag to read 200ml bag

Updated on 16 May 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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)

Free text change information supplied by the pharmaceutical company

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 IMB Pharmacovigilence, Earlsfort Terrace, IRL- Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie

Updated on 16 May 2014 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 2 November 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Implementation of changes requested by the National Competent Authority following assesssment of
Class labelling - implementation of wording changes for which no few additional data are submitted by the MAH
PSUR - implementation of wording changes for which no few additional data are submitted by the MAH

Updated on 26 October 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions

Updated on 13 August 2012 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 July 2011 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided