Ondansetron 2mg/ml Solution for Injection or Infusion

  • Name:

    Ondansetron 2mg/ml Solution for Injection or Infusion

  • Company:
    info
  • Active Ingredients:

    Ondansetron hydrochloride dihydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/06/18

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Summary of Product Characteristics last updated on medicines.ie: 14/6/2019

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Gerard Laboratories

Gerard Laboratories

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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 14 June 2019 SmPC

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  • Change to improve clarity and readability

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

Updated on 20 June 2018 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 4.5 - 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 20 June 2018 PIL

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  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Updated on 7 April 2016 SmPC

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  • New SmPC for new product

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Updated on 7 April 2016 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

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4.9. Overdose

 

Symptoms and Signs

There is limited experience of ondansetron overdose, however, a limited number of patients received overdoses. In the majority of cases, symptoms were similar to those already reported in patients receiving recommended doses (see section 4.8). Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second degree AV block. In all instances, the events resolved completely.

Ondansetron prolongs QT interval in a dose-dependent manner. ECG monitoring is recommended in cases of overdose.

  

Treatment

There is no specific antidote for ondansetron, therefore in all cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate.

The use of ipecacuanha to treat overdose with Ondansetron is not recommended as patients are unlikely to respond due to the anti-emetic action of Ondansetron itself.

 

Paediatric population

Paediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeded estimated ingestion of 4 mg/kg) in infants and children aged 12 months to 2 years.

Updated on 6 April 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 April 2016 PIL

Reasons for updating

  • Change to instructions about overdose
  • Change to date of revision

Updated on 3 February 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

 

4.2. Posology and method of administration

 

4.2.1. Chemotherapy and Radiotherapy induced Nausea and Vomiting

Adults:

 

The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of Ondansetron should be flexible in the range of 8-32 mg a day and selected as shown below.

 

Emetogenic Chemotherapy and Radiotherapy

For patients receiving emetogenic chemotherapy or radiotherapy Ondansetron can be given either by oral or intravenous administration.

For most patients receiving emetogenic chemotherapy or radiotherapy, Ondansetron 8 mg should be administered as a slow intravenous

injection (in not less than 30 seconds) or as a short-time intravenous infusion over 15 minutes immediately before treatment, followed by 8 mg orally twelve hourly.

 


Highly emetogenic Chemotherapy

For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, Ondansetron can be given by

oral, rectal or intravenous administration. Ondansetron has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy:

 

 A single dose of 8 mg by slow intravenous injection (in not less than 30 seconds) immediately before chemotherapy.

 A dose of 8 mg by slow

intravenous injection (in not less than 30 seconds) immediately before chemotherapy, followed by two further intravenous injections (in not less than 30 seconds) of 8 mg four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.

 

 

A maximum initial intravenous dose of 16 mg diluted in 50-100 ml of saline or other compatible infusion fluid (see section 6.6) and infused over not less than 15 minutes immediately before chemotherapy. The initial dose of Ondansetron may be followed by two additional 8 mg intravenous doses (in not less than 30 seconds) four hours apart.


A single dose greater than 16 mg must not be given due to dose dependent increase of QT-prolongation risk (see sections 4.4, 4.8 and 5.1).

 


Elderly patients

:

 

In patients 65 to 74 years of age

 

, the dose schedule for adults can be followed. All intravenous doses should be diluted in 50-100 ml of saline or other compatible infusion fluid (see section 6.6) and infused over 15 minutes.

 

In patients 75 years of age or older

 

, the initial intravenous dose of Ondansetron should not exceed 8 mg. All intravenous doses should be diluted in 50-100 ml of saline or other compatible infusion fluid (see section 6.6) and infused over 15 minutes. The initial dose of 8 mg may be followed by two further intravenous doses of 8 mg, infused over 15 minutes and given no less than four hours apart (see section 5.2).

 

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 Section, Irish Medicines Board, Kevin O’ Malley House, Earlsfort Centre, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpraimb.ie; Ee-mail: medsafetyimbpharmacovigilance@imb.ie

 
















Updated on 21 January 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 26 May 2014 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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

section 4.3 concomitant use with apomorphine added
section 4.4 Avoid ondansetron in patients with congenital long QT syndrome.

Hypokalemia and hypomagnesemia should be corrected prior to ondansetron administration.

 

There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs)). If concomitant treatment with ondansetron and other serotonergic drugs is clinically warranted, appropriate observation of the patient is advised.



section 4.5

Use of ondansetron with QT prolonging drugs may result in additional QT prolongation.

Concomitant use of ondansetron with cardiotoxic drugs (e.g. anthracyclines such as doxorubicin, daunorubicin or trastuzumab),antiobiotics (such as erythromycin or ketoconazole),antiarrhythmics (such as amiodarone) and beta blockers (such as atenolol or timolol) may increase the risk of arrhythmias (see section 4.4).

 

There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including SSRIs and SNRIs) (see section 4.4).

 

Apomorphine

Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated.

 

Phenytoin, Carbamazepine and Rifampicin

In patients treated with potent inducers of CYP3A4 (i.e. Phenytoin, Carbamazepine and Rifampicin), the oral clearance of ondansetron was increased and ondansetron blood concentrations were decreased.

 

Tramadol

Data from small studies indicate that ondansetron may reduce the analgesic effect of tramadol.

section 4.7

In psychomotor testing ondansetron does not impair performance nor cause sedation. No detrimental effects on such activities are predicted from the pharmacology of ondansetron.



section 4.9

Ondansetron prolongs QT interval in a dose-dependent manner. ECG monitoring is recommended in cases of overdose.

 


revision date

section 4.9revision date

Updated on 9 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 26 July 2013 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 4.3 - 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic 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)

Free text change information supplied by the pharmaceutical company

The following sections were updated:

Sections 2, 4.2.1,4.2.2, 4.3, 4.4, 4.6, 4.8, 5.1, 6.6.1,10

Updated on 24 July 2013 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 information about pregnancy or lactation
  • Change to how the medicine works
  • Change to date of revision

Updated on 8 August 2012 SmPC

Reasons for updating

  • Change to product name
  • 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

Change to product name from Emizof 2mg/ml Solution for Injection or Infusion to:

Ondansetron 2mg/ml Solution for Injection or Infusion

Updated on 1 August 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to product name

Updated on 16 March 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision

Updated on 15 March 2012 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

section 4.1

4.1. Therapeutic Indications

 

AdultsEmizof is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting (PONV).

 

Paediatric population

Emizof is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged ≥ 6 months, and for the prevention and treatment of post-operative nausea and vomiting (PONV) in children aged ≥ 1 month.

section 4.2.1    Chemotherapy and Radiotherapy induced Nausea and Vomiting

Paediatric Population added & table 1

section 4.2.2    Post-Operative Nausea and Vomiting (PONV)

 

 heading added Adults

added:Post-operative nausea and vomiting in children aged ≥ 1 month and adolescents

section 4.4 Special warnings and special precautions for use

added

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT3 receptor antagonists.

Respiratory events should be treated symptomatically and clinicians should pay particular attention to them as precursors of hypersensitivity reactions.

 

In patients with adenotonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Therefore, such patients should be followed carefully after ondansetron.

added section on Paediatric population

section 4.5 Interaction with other medicinal products and other forms of interaction

 

There is no evidence that ondansetron either induces or inhibits the metabolism of other drugs commonly co-administered with it.  Specific studies have shown that there are no pharmacokinetic interactions when ondansetron is administered with alcohol, temazepam, frusemide, tramadol, alfentanil, morphine, lignocaine, propofol and thiopental.
Use of ondansetron with QT prolonging drugs may result in additional QT prolongation.
Concomitant use of ondansetron with cardiotoxic drugs (e.g. anthracyclines) may increase the risk of arrhythmias (see section 4.4).

section 4.6 Fertility, pregnacny and lactation

The safety of ondansetron for use in human pregnancy has not been established. No clinical data on exposed human pregnancies are available. Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo, or foetus, the course of gestation and peri- and post-natal development (see section 5.3).


added

 

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000). Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo was taken into account. Rare and very rare events were generally determined from post-marketing spontaneous data.

 

The following frequencies are estimated at the standard recommended doses of ondansetron according to indication and formulation.

 

Very common: Headache.

 

Rare: Dizziness during rapid IV administration.

 

 

Rare: Transient visual disturbances (e.g. blurred vision) predominantly during IV administration.

 

Vascular disorders

Common: Sensation of warmth or flushing.

 

Uncommon: Hypotension.

 

Respiratory, thoracic and mediastinal disorders

Uncommon: Hiccups.

 

Local burning sensation following insertion of suppositories.

 

These events were observed commonly in patients receiving chemotherapy with

cisplatin.

 

General disorders and administration site conditions

 

Common: Local IV injection site reactions.

hypersensitivity reactions around the injection site (e.g. rash, urticaria, itching) may occur, sometimes extending along the drug administration vein.

 

Paediatric population

 

The adverse event profiles in children and adolescents were comparable to that seen in

adults.

 

4.9. Overdose

 

Symptoms and Signs

 

Little is known at present about overdosage with ondansetron, however, a limited number of patients received overdoses. In the majority of cases, symptoms were similar to those already reported in patients receiving recommended doses (see section 4.8). Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second degree AV block. In all instances, the events resolved completely.

 

Treatment

 

Paediatric population:

 

Chemotherapy-induced nausea and vomiting

The efficacy of Ondansetron in the control of emesis and nausea induced by cancer chemotherapy was assessed in a double-blind randomised trial in 415 patients aged 1 to 18 years. On the days of chemotherapy, patients received either ondansetron 5mg/m2 i.v. + after 8-12hrs ondansetron 4 mg p.o. or ondansetron 0.45 mg/kg i.v. + after 8-12hrs placebo p.o. Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 3 days. Complete control of emesis on worst day of chemotherapy was 49 % (5 mg/m2 i.v. + ondansetron 4 mg p.o.) and 41 % (0.45 mg/kg i.v. + placebo p.o.). Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 3 days.

 

A double-blind randomise placebo-controlled trial in 438 aged 1 to 17 years demonstrated complete control of emesis on worst day of chemotherapy in 73% of patients when ondansetron was administered intravenously at a dose of 5 mg/m2 i.v. together with 2-4 mg dexamethasone p.o. and in 71% of the patients when ondansetron was administered as a syrup at a dose of 8 mg + 2-4 mg dexamethasone p.o. on the days of chemotherapy. Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 2 days.

 

The efficacy of ondansetron in 75 children aged 6 to 48 months was investigated in an open-label, non-comparative, single-arm study. All children receive three

0.15 mg/kg doses of intravenous ondansetron, administered at 30 minutes before the start of chemotherapy and then at four and eight hours after the first dose.

Complete control of emesis was achieved in 56% of patients.

 

Another open-label, non-comparative, single-arm study investigated the efficacy of one intravenous dose of 0.15 mg/kg ondansetron followed by two ondansetron doses of 4 mg for children aged < 12 yrs and 8 mg for children aged ≥12yrs (total no. of children n = 28). Complete control of emesis was achieved in 42% of patients.

 

Prevention of post-operative nausea and vomiting

The efficacy of a single dose of Ondansetron in the prevention of post-operative nausea and vomiting was investigated in a randomised, double-blind, placebo-controlled study in 670 children aged 1 to 24 months (post-conceptual age ≥ 44 weeks, weight ≥ 3kg). Included subjects were scheduled to undergo elective surgery under general anaesthesia and had an ASA status ≤ III. A single dose of ondansetron 0.1 mg/kg was administered within five minutes following induction of anaesthesia. The proportion of subjects who experienced at least one emetic episode during the 24-hour assessment period (ITT) was greater for patients on placebo than those receiving ondansetron (28% vs. 11|% p<0.0001).

 

Paediatric population

 

Children and adolescents (aged 1 month 17 years)

In paediatric patients aged 1 to 4 months (n=19) undergoing surgery, weight normalised clearance was approximately 30% lower than in patients aged 5 to 24 months (n=22) but comparable to the patients aged 3 to 12 years. The half-life in the patient population aged 1 to 4 months was reported to average 6.7 hours compared to 2.9 hours for the patients in the 5 to 24 months and 3 to 12 year age range. The differences in the pharmacokinetic parameters in the 1 to 4 months patient population can de explained in part by a higher percentage of total body water in neonates and infants and a higher volume of distribution for water soluble drugs like ondansetron.

 

In paediatric patients aged 3 to 12 years undergoing elective surgery with general anaesthesia, the absolute values for both the clearance and the volume of distribution of ondansetron were reduced in comparison to values with adult patients. Both parameters increased in a linear fashion with weight and by 12 years of age, the values were approaching those of young adults. When clearance and volume of distribution values were normalised by body weight, the values of these parameters were similar between the different age group populations. Use of weight base dosing compensates for age-related changes and is effective in normalising systemic exposure in paediatric patients.

 

Population pharmacokinetic analysis was performed on 74 paediatric cancer patients aged 6 to 48 months and 41 surgery patients aged 1 to 24 months following intravenous administration of ondansetron. Based on the population pharmacokinetic parameters for patients aged 1 month to 48 months, administration of the adult based dose (0.15 mg/kg intravenously every 4 hours for 3 doses) would result in a systemic exposure (AUC) comparable to that observed in paediatric surgery patients (aged 5 to 24 months), paediatric cancer patients (aged 3 to 12 years), at a similar doses, as shown in Table C. This exposure (AUC) is consistent with the exposure-efficacy relationship described previously in paediatric cancer subjects, which showed a 50% to 90% response rate with AUC values ranging from 170 to 250 ng.h/mL.

 

Table C. Pharmacokinetics in Paediatric Patients 1 Month to 18 Years of Age

 

Study

Patient Population (Intravenous dose)

Age

N

AUC (ng.h/mL)

CL (L/h/kg)

Vd55 (L/kg)

T 2/2 (h)

Geometric Mean

Mean

S3A403191

Surgery (0.1 or 0.2 mg/kg)

1 to 4 months

19

360

0.401

3.5

6.7

S3A403191

Surgery (0.1 or 0.2 mg/kg)

5 to 24 months

22

236

0.581

2.3

2.9

S3A40320 & S3A40319 Pop PK2,3

Cancer/Surgery (0.15 mg/kg q4h/0.1 or 0.2 mg/kg)

1 to 48 months

115

257

0.582

3.65

4.9

S3KG024

Surgery

(2 mg or 4 mg)

3 to 12 years

21

240

0.439

1.65

2.9

S3A-150

Cancer (0.15 mg/kg q4h)

4 to 18 years

21

247

0.599

1.9

2.8

 

1 Ondansetron single intravenous dose: 0.1 or 0.2 mg/kg

2 Population PK Patients: 64% cancer patients and 36% surgery patients.

3 Population estimates shown; AUC based on dose of 0.15 mg/kg.

4 Ondansetron single intravenous dose: 2 mg (3 to 7 years) or 4 mg (8 to 12 years)

Updated on 10 May 2011 PIL

Reasons for updating

  • Addition of manufacturer

Updated on 6 May 2011 PIL

Reasons for updating

  • Addition of manufacturer

Updated on 26 January 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • 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 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

section 1: name of medicinal product updated from 'Emizof 2mg/ml Solution for Injection'  to 'Emizof 2mg/ml Solution for Injection or Infusion'

section 2: Qualitative & Quantitative composition-'2ml ampoule & 4ml ampoule updated to 'Emizof 4mg/2ml Solution for Injection' & 'Emizof 8mg/4ml Solution for Injection'

section 3:Pharmaceutical form updated from 'Solution for Injection of infusion; Clear solution' to 'Solution for injection or infusion:Clear, colourless solution, practically free of particles'

section 4.4 Special warnigs and precaution for use-'added--Very rarely and predominantly with intravenous Emizof transient ECG changes including QT interval prolongation have been reported.Therefore caution should be exercised in patients with cardiac rhythm or conduction disturbances, in patients treated with anti-arrhythmic agents or beta-adrenergic blocking agents and in patients with significant electrolyte disturbances.'

section 4.8 Undesirable effects-'Eye Disorders' added

section 6.3 Shelf Life--36 months changed to 3 years.Added 'Once opened use immediately'
added 'Once Diluted'

section 6.4 Special precaution for storage--added 'store in the original package'
updated 'For storage of reconstitued/diluted solution see section 6.3' to 'For storage of diluted solutions see section 6.3'

section 6.5 Nature and contents of container--added 'Not all pack sizes may be marketed'

section 6.6 updated the sentence 'Only clear solution practically free from particles etc' updated to 'Only clear and colourless solutions etc'

section 6.6.1 --removed the sentence ' or stored at 2-8oC for no more than 24 hours before start of administration'..& added 'From a microbiological point of view, the product should be used immediately.If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8oC, unless dilution has taken place in controlled and validated aseptic conditions.'


section 6.6.2--removed 'store in the original package.The product etc.

Updated on 25 January 2011 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to product name

Updated on 6 April 2010 SmPC

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  • New SPC for medicines.ie

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None provided

Updated on 29 March 2010 PIL

Reasons for updating

  • New PIL for medicines.ie