Ranitidine 50mg/2ml Solution for Injection and Infusion

  • Name:

    Ranitidine 50mg/2ml Solution for Injection and Infusion

  • Company:
    info
  • Active Ingredients:

    Ranitidine 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: 27/03/19

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Summary of Product Characteristics last updated on medicines.ie: 22/3/2019

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Alliance Pharmaceuticals Ireland

Alliance Pharmaceuticals Ireland

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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 27 March 2019 PIL

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  • Change to section 6 - marketing authorisation holder

Updated on 22 March 2019 PIL

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  • Change to section 6 - marketing authorisation holder

Updated on 22 March 2019 SmPC

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  • Change to section 7 - Marketing authorisation holder

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

Updated on 20 July 2018 SmPC

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  • File format updated to PDF

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File format update to PDF

Updated on 4 August 2017 SmPC

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  • New SmPC for new product

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Updated on 4 August 2017 SmPC

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

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Correction of Date of revision of text$0$0

Updated on 28 October 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - 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 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

2.      QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each one ml of solution contains 25mg ranitidine as ranitidine hydrochloride. Each 2ml ampoule contains 50mg ranitidine.

Excipient(s) with known effect:

Disodium hydrogen phosphate dihydrate

Sodium chloride

.Each ampoule contains 0.55mg (0.014mmol) of Potassium and 2.23mg (0.097mmol) of Sodium.

 

4.      Clinical particulars

 

4.1    Therapeutic indications

 

Adults

Ranitidine Solution for Injection is indicated for the treatment of duodenal ulcer, benign gastric ulcer, post - operative ulcer, and of Zollinger - Ellison Syndrome.

 

4.2    Posology and method of administration

 

See section 5.2 Pharmacokinetic Properties – Special Patient Populations

Posology

Adults (including elderly) and adolescents (12 years and older)

 

Patients with Renal Impairment

Accumulation of ranitidine with resulting elevated plasma concentrations will occur in patients with renal impairment (creatinine clearance less than 50ml/min).  It is recommended in such patients that ranitidine be administered in doses of 25mg.

 

MethodRoute of Administration

Intravenous or intramuscular injection

 

For instructions on dilution of the medicinal product before administration, see section 6.6

 

 

4.4        Special warnings and precautions for use

 

Treatment with a histamine H2-antagonist may mask the symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition. Where gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with ranitidine is started.

Malignancy

The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer as treatment with ranitidine may mask symptoms of gastric carcinoma

 

Renal Disease

Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with  renal impairment.  The dosage should be adjusted as detailed in Section 4.2 Patients with Renal Impairment.Posology and Method of Administration.

 

 

It has been reported that the use of higher than recommended doses of intravenous H2-antagonists has been associated with rises in liver enzymes when treatment has been extended beyond five days.

 

Although clinical reports of acute intermittent porphyria associated with ranitidine administration have been rare and inconclusive, ranitidine should be avoided in patients with a history of this condition. Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks.  Ranitidine should therefore be avoided in patients with a history of acute porphyria

 

In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia. A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of ranitidine aloneof H2 receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk increase of 1.82 (95% CI, 1.26–2.64).

 

4.5        Interaction with other medicinal products and other forms of interaction

 

Interactions occur by several mechanisms including:

1) Inhibition of cytochrome P450-linked mixed function oxygenase system:

Ranitidine, at blood levels produced by standard doses, does not inhibit or interact significantly with the hepatic cytochrome P450-linked mixed function oxygenase system.

Accordingly, ranitidine in at usual therapeutic doses, does not potentiate the actions of drugs which are inactivated by this enzyme systems such as; these include diazepam, lidocaine, phenytoin, propranolol and theophylline.

 

There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.

 

4.6       Fertility, pregnancy and lactation

 

Pregnancy

Ranitidine crosses the placenta but therapeutic doses administered to obstetric patients in labour or undergoing caesarean section have been without any adverse effect on labour, delivery or subsequent neonatal progress. Ranitidine is also excreted in human breast milk. Like other drugs, ranitidine should only be used during pregnancy or lactation if considered essential by a physician. 

 

Breast-feeding

Ranitidine is also excreted in human breast milk.  Like other drugs, ranitidine should only be used during breast-feeding if considered essential.

 

Fertility

There are not data on the effects of ranitidine on human fertility. There were no effects on male and female fertility in animal studies (see section 5.3).

 

 

4.8        Undesirable effects

 

The following convention has been utilised for the classification of undesirable effects:

very common (≥1/10);,

common (≥1/100,, <1/10);,

uncommon (≥1/1000, ≤1/100);,

rare (≥1/10,000, ≤1/1000);,

very rare (≤1/10,000), 

Aadverse event frequencies have been estimated from spontaneous reports from post-marketing data).

 

Blood & Lymphatic System Disorders

Very rare:

Blood count changes (leucopenia, thrombocytopenia). These are usually reversible. Agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or marrow aplasia.

Immune System Disorders

Rare:

Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain).

Very rare:

Anaphylactic shock

These events have been reported after a single dose.

Not known:Unknown

Dyspnoea

 

These events have been reported after a single dose

Psychiatric Disorders

Very rare:

Reversible mental confusion, depression and hallucinations.

These adverse reactions have been reported predominantly in severely ill patients, in the elderly and in nephropathy patients.

Nervous System Disorders

Very rare:

Headache (sometimes severe), dizziness and reversible involuntary movement disorders.

 

 

Eye Disorders

Very rare:

Reversible blurred vision. There have been reports of blurred vision, which is suggestive of a change in accommodation.

Cardiac Disorders

Very rare:

As with other H2 receptor antagonists bradycardia, A-V Block, tachycardia and asystole.

Vascular Disorders

 

Very rare:

Vasculitis.

Gastrointestinal Disorders

Uncommon:

Abdominal pain, constipation, nausea (these symptoms mostly improved during continued treatment).

 

Very rare:

Acute pancreatitis, diarrhoea.

Hepatobiliary Disorders

Rare:

Transient and reversible changes in liver function tests.

Very rare:

Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, these were usually reversible.

Skin and Subcutaneous Tissue Disorders

Rare:

Skin Rash.

Very rare:

Erythema multiforme, alopecia.

Musculoskeletal and Connective Tissue Disorders

Very rare:

Musculoskeletal symptoms such as arthralgia and myalgia.

Renal and Urinary Disorders

Rare:

Elevation of plasma creatinine (usually slight; normalised during continued treatment).

Very rare:

Acute interstitial nephritis.

Reproductive System and Breast Disorders

Very rare:

Reversible impotence, breast symptoms and breast conditions (such as gynaecomastia and galactorrhoea).

 

Paediatric population

The safety of ranitidine has been assessed in children aged 0 to 16 years with acid-related disease and was generally well tolerated with an adverse event profile resembling that in adults.  There are limited long term safety data available, in particular regarding growth and development.

 

4.9    Overdose

 

Treatment

Symptomatic and supportive therapy should be given as appropriate.  Ranitidine may be removed by haemodialysis.

 

 

5.      PHARMACOLOGICAL PROPERTIES

 

5.1    Pharmacodynamic properties

 

 

Mechanism of action

Ranitidine is a specific, rapidly acting histamine H2-antagonist. It inhibits basal and stimulated secretion of gastric acid, reducing both the volume, and the acid and pepsin content of the secretion.

 

Paediatric population

The clinical data available mentions the use of ranitidine in children to prevent stress ulcers. No direct evidence for prevention of stress ulcers is available. Treatment for these patients is based on the observation that pH is above 4 after administration of ranitidine. The value of this surrogate parameter in children with stress ulcers remains to be established.

 

 

5.2        Preclinical safety data

 

 Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.

 

6.      PHARMACEUTICAL PARTICULARS

 

6.1    List of excipients

 

Potassium dihydrogen phosphate

Disodium hydrogen phosphate dihydrate

Sodium chloride

Water for Injections

 

6.2    Incompatibilities

 

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.None

10.    DATE OF REVISION OF THE TEXT

 

February 20156

Updated on 24 October 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 October 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 1 May 2015 SmPC

Reasons for updating

  • 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 4.8 updated as follows:

Blood & Lymphatic System Disorders

Unknown

Dyspnoea

Psychiatric Disorders

Very rare:

Reversible mental confusion, depression and hallucinations.

These adverse reactions have been reported predominantly in severely ill patients, in the and elderly and in nephropathy patients.

Cardiac Disorders

Very rare:

As with other H2 receptor antagonists bradycardia, A-V Block, tachycardia and asystole.

Updated on 30 April 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 9 February 2015 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 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Changes are highlighted in red text below:

4.2     Posology and method of administration

 

For intravenous or intramuscular injection or, after dilution, for intravenous infusion. Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.

See section 5.2 Pharmacokinetic Properties – Special Patient Populations

Adults (including elderly) and adolescents (12 years and older)

Ranitidine Solution for Injection may be given as:

·         A slow intravenous injection (over at least two minutes) up to a maximum of 50 mg, after dilution to a volume of 20 ml per 50 mg dose.  This dose may be repeated every six 6 to eight 8 hours or 

·         As an intermittent intravenous infusion at a rate of 25 mg per hour for two hours.  The infusion may be repeated at six 6 to eight 8 hour intervals

·         As an intramuscular injection of 50 mg (2ml) every six 6 to eight 8 hours.

 

Prophylaxis of haemorrhage from stress ulceration or recurrent haemorrhage:

Patients considered to be still at risk may then be treated orally with Ranitidine tablets 150 mg twice daily.

 

 

Prophylaxis of Mendleson’s syndrome:

In patients considered at risk of developing acid aspiration (Mendelson’s) syndrome, Ranitidine Solution for Injection 50 mg may be given intramuscularly or by slow intravenous injection (over 2 minutes), 45 to 60 minutes before induction of general anaesthesia.

 

Renal Impairment

Accumulation of ranitidine with resulting elevated plasma concentrations will occur in patients with severe renal impairment (creatinine clearance less than 50ml/min).  It is recommended in such patients that Ranitidine ranitidine Solution for Injection be administered in doses of 25mg.

Route of Administration

Intravenous or intramuscular injection

 

 

4.3     Contraindications

 

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

 

4.4      Special warnings and precautions for use

 

Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment. 

 

Asystole and bradycardia Bradycardia in association with rapid administration of ranitidine injection has been reported rarely, usually in patients with factors predisposing to cardiac rhythm disturbances.

 

A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of H2 receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk increase of 1.82 (95% CI, 1.26–2.64).1.63 (95% CI, 1.07–2.48). 

 

 

4.8      Undesirable effects

 

Cardiac Disorders

Very rare:

As with other H2 receptor antagonists bradycardia, and A-V Block and asystole.

 

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: drugs for peptic ulcer and gastro-oesophageal reflux disease.  H2 – receptor antagonist.

Treatment for these patients is based on the observation that pH is below above 4 after administration of ranitidine.

 

 

 

 

Updated on 5 February 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • 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 dosage and administration
  • Addition of information on reporting a side effect.

Updated on 11 March 2014 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)

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Amend date of revision of text to June 2013

Updated on 10 February 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

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Changes are highlighted in red text below:

4.2     Posology and method of administration

Prophylaxis of stress ulceration in seriously ill patients

The recommended dose for prophylaxis of stress ulceration is 1mg/kg (maximum 50 mg) every 6h to 8h.

Alternatively treatment can be continuous, administering 125 - 250 micrograms/kg/hr as continuous infusion.

 

Updated on 5 February 2014 PIL

Reasons for updating

  • Change to further information section

Updated on 24 June 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 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

Excipient(s) with known effect:

Disodium hydrogen phosphate dihydrate

Sodium chloride.

 

4.2     Posology and method of administration

 

Children / Infant (6 months to 11 years)

Patients over 50 years of age

See Section 5.2 Pharmacokinetic properties  (Special Patient Populations, Patients over 50   years of age).

 

 

4.4      Special warnings and precautions for use

 

Postmarketing data indicate reversible mental confusion, depression, and hallucinations have been reported most frequently in severely ill and elderly patients.  (See Section 4.8 Undesirable effects).

 

 

4.6       Fertility, Ppregnancy and lactation

 

There are not data on the effects of ranitidine on human fertility. There were no effects on male and female fertility in animal studies.

 

4.8      Undesirable effects

 

The following convention has been utilised for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000,. <1/1000), very rare (<1/10,000), unknown (cannot be Adverse event frequencies have been estimated from spontaneous reports from post-marketing the available data).

 

Blood & Lymphatic System Disorders

UnknownVery rare:

Blood count changes (leucopenia, thrombocytopenia). These are usually reversible. Agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or marrow aplasia.

Immune System Disorders

UncommonRare:

Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain).

UnknownVery rare:

Anaphylactic shock

These events have been reported after a single dose.

Psychiatric Disorders

Very Rare:

Depression.

UnknownVery rare:

Reversible mental confusion,depression and hallucinations.

These have been reported predominantly in severely ill and elderly patients.

Nervous System Disorders

CommonVery rare:

Headache (sometimes severe), and dizziness and reversible involuntary movement disorders..

Unknown:

Reversible involuntary movement disorders

Eye Disorders

UncommonVery rare:

Reversible blurred vision.

There have been reports of blurred vision, which is suggestive of a change in accommodation.

Cardiac Disorders

UnknownVery rare:

As with other H2 receptor antagonists bradycardia and A-V Block.

Vascular Disorders

 

UnknownVery rare:

Vasculitis.

Gastrointestinal Disorders

UnCcommon:

Abdominal pain, constipation, nausea (these symptoms mostly improved during continued treatment).

Diarrhoea.

UnknownVery rare:

Acute pancreatitis, diarrhoea.

Hepatobiliary Disorders

Very Rare:

Transient and reversible changes in liver function tests.

UnknownVery rare:

Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, these were usually reversible.

Skin and Subcutaneous Tissue Disorders

UncommonRare:

Skin Rash.

UnknownVery rare:

Erythema multiforme, alopecia.

Musculoskeletal and Connective Tissue Disorders

UnknownVery rare:

Musculoskeletal symptoms such as arthralgia and myalgia.

Renal and Urinary Disorders

Rare:

Elevation of plasma creatinine (usually slight; normalised during continued treatment).

UnknownVery rare:

Acute interstitial nephritis.

Reproductive System and Breast Disorders

UnknownVery rare:

Reversible impotence., Bbreast symptoms and breast conditions (such as gynaecomastia and galactorrhoea).

 

5.2      Pharmacokinetic properties

 

Absorption

Absorption of ranitidine after intramuscular injection is rapid and peak plasma concentrations are usually achieved within 15 minutes of administration.

 

Distribution

Ranitidine is not extensively bound to plasma proteins (15%), but exhibits a large volume of distribution ranging from 96 to 142 L.

 

Metabolism

Ranitidine is not extensively metabolised. The fraction of the dose recovered as metabolites is similar after both oral and i.v. dosing; and includes 6% of the dose in urine as the N-oxide, 2% as the S-oxide, 2% as desmethylranitidine and 1 to 2% as the furoic acid analogue

 

Elimination

The elimination of the drug is primarily by tubular secretion. The elimination half-life of ranitidine is 2-3 hours.  In studies with 150mg 3H-ranitidine, 93% of an intravenous dose was excreted in urine and 5% in faeces. Analysis of urine excreted in the first 24 hours after dosing showed that 70% of the intravenous dose was eliminated unchanged. About 6% of the dose is excreted in the urine as the N-oxide, 2% as desmethyl ranitidine and 1-2% as the furoic acid analogue. Plasma concentrations decline bi-exponentially, with a terminal half-life of 2-3 hours.  The major route of elimination is renal.  After IV administration of 150 mg 3H-ranitidine, 98% of the dose was recovered, including 5% in faeces and 93% in urine, of which 70% was unchanged parent drug.  After oral administration of 150 mg 3H-ranitidine, 96% of the dose was recovered, 26% in faeces and 70% in urine of which 35% was unchanged parent drug.  Less than 3% of the dose is excreted in bile.  Renal clearance is approximately 500 mL/min, which exceeds glomerular filtration indicating net renal tubular secretion.

 
Patients over 50 years of age

In patients over 50 years of age, half-life is prolonged (3-4 h) and clearance is reduced, consistent with the age-related decline of renal function.  However, systemic exposure and accumulation are 50% higher.  This difference exceeds the effect of declining renal function, and indicates increased bioavailability in older patients.

 

 

5.3      Preclinical safety data

 

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC. Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.

 

 

 

Updated on 20 June 2013 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 further information section

Updated on 14 August 2012 PIL

Reasons for updating

  • Change to date of revision

Updated on 20 April 2012 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

Updated on 17 April 2012 PIL

Reasons for updating

  • New PIL for medicines.ie