Zovirax IV 250mg

  • Name:

    Zovirax IV 250mg

  • Company:
    info
  • Active Ingredients:

    Aciclovir sodium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/09/15

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Summary of Product Characteristics last updated on medicines.ie: 21/9/2015
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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101 - 125 of 136 items.Total: 6 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 21 September 2015 PIL

Reasons for updating

  • Change to dosage and administration
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 21 September 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 September 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 September 2015 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 - how to report a side effect
  • 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 6.6 - 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

Minor Editorial updates to following sections:   1,  2,  4.3,  4.4,  4.5,  4.6,  5.1,  5.2,  5.3

Section 4.2 – Update to Dosage for Infants and Children, Addition regarding Administration, Minor editorial update, Change to dosage for renal impairment


Section 4.8 – Minor editorial update, Addition of ADR reporting details


Section 6.6 – Update to information on administration


Updated on 21 July 2015 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Update to MA holder contact details - Address change

Updated on 21 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 9 August 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.2 – the dosing information was updated

Section 5.2 – additional information

Updated on 8 August 2014 PIL

Reasons for updating

  • Change to date of revision

Updated on 11 October 2012 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 11 October 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 4.6 - Pregnancy and lactation
  • 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

Changes to:

 

Section 4.3  - Contraindications,

Section 4.4  - Special warnings and precautions for use,

Section 4.6  - Pregnancy and lactation,

Section 5.3  - Preclinical safety data

Updated on 21 November 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 2 December 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 10 September 2010 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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.2 Posology and method of administration

Under the subheading ‘Dosage in the elderly’ updated the wording to read:

The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see Renal impairment below). Adequate hydration should be maintained.

 

Under the subheading ‘Renal impairment’ added the following warning:

Renal impairment: Caution is advised when administering aciclovir i.v. for infusion to patients with impaired renal function. Adequate hydration should be maintained.

 

4.4 Special warnings and precautions for use

Under the new subheading Use in patients with renal impairment and in elderly patients’ added the following warning:

Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see section 4.2). Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment (see section 4.8).

 

Added the following warning regarding the sodium content:

This medicinal product contains 1.1 mmol sodium per vial. To be taken into consideration by patients on a controlled sodium diet.

 

4.8 Undesirable Effects

Regarding the adverse events listed under Psychiatric and nervous system disorders’, updated the wording to read:

The above events are generally reversible and usually reported in patients with renal impairment or with other predisposing factors (see section 4.4).

 

Updated on 17 November 2009 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 4.7 - Effects on ability to drive and use machines
  • 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



Updates to SPC and package leaflet due to Renewal and safety variation regarding renal pain

 

 

SPC updates:

Sections 1, 4.1, 4.2, 4.3, 4.4, 4.7 and 6.6:

The term ‘I.V.’ replaced ‘IV’

 

Section 2:

-          The following was added:

Each vial contains 26 mg of sodium.

The quantity of sodium after reconstitution in 10 ml of water for injection is approximately 2.587 mg/ml.

The quantity of sodium after reconstitution in 10 ml of NaCl (0.9 % w/v) is approximately 11.587 mg/ml.

 

-          The reference to section 6.6 was updated to include the detail ‘full list’

 

Section 4.8

‘Renal pain’ added as a very rare side effect, with the statement added that ‘renal pain may be associated with renal failure’

 

Section 6.2

Updated from ‘none known’ to ‘this medicinal product should not be mixed with other medicinal products except those mentioned in section 6.6.’

 

Section 6.3:

-          Added statement clarifying that the shelf life of 5 years is ‘prior to reconstitution’.

-          Added statement that the ‘reconstituted or diluted solutions should not be refrigerated’

 

Section 6.4

Included reference to section 6.3

 

Section 6.5

Container description changed from ‘vial’ to ‘bottle’

 

Section 6.6

-          Added statement regarding safe disposal:

Any unused product or waste materials should be disposed of in accordance with local requirements.

-          Added statement that the product is ‘for single use only’.

-          Moved instruction regarding reconstitution under aseptic conditions (no antimicrobial agents present in the product) from under the sub-heading ‘Administration’ to under the sub-heading ‘Reconstitution’

-          Moved warning against refrigeration and turbidity/crystallisation from under the sub-heading ‘Administration’ to under the sub-heading ‘Reconstitution’

 

Section 7

Ireland added to address

 

Sections 9 and 10

Updated to reflect the Renewal

 

 

 

 

 

 

 

 

 

 

Updated on 10 November 2009 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects

Updated on 18 September 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 24 September 2007 PIL

Reasons for updating

  • Change to further information section

Updated on 14 June 2007 SmPC

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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

4.7 Effects on Ability to Drive and Use Machines

 

No data available.

Zovirax IV for Infusion is generally used in an in-patient hospital population and information on ability to drive and operate machinery is not usually relevant. There have been no studies to investigate the effect of Zovirax on driving performance or the ability to operate machinery.

 


4.8 Undesirable Effects

 

Gastrointestinal: Nausea and vomiting have been reported in patients receiving therapy with Zovirax IV for Infusion.

 

Haematological: Decreases in haematological indices (anaemia, thrombocytopenia, and leucopenia).

 

Hypersensitivity and skin: Rashes including photosensitivity, urticaria, pruritus, fevers and rarely dyspnoea, angioedema and anaphylaxis

 

Severe local inflammatory reactions sometimes leading to breakdown of the skin have occurred when Zovirax IV for Infusion has been inadvertently infused into extravascular tissues.

 

Kidney: Rapid increases in blood urea and creatinine levels may occasionally occur in patients given Zovirax IV for Infusion. This is believed to be related to peak plasma levels and the state of hydration of the patient. To avoid this effect the drug should not be given as an intravenous bolus injection but by slow infusion over a one-hour period.

 

Adequate hydration of the patient should be maintained. Renal impairment developing during treatment with Zovirax IV for Infusion usually responds rapidly to rehydration of the patient and/or dosage reduction or withdrawal of the drug. Progression to acute renal failure, however, can occur in exceptional cases.

 

Liver: Reversible increases in bilirubin and liver-related enzymes, hepatitis and jaundice have been reported on very rare occasions,

 

Neurological: Reversible neurological reactions such as confusion, hallucinations, agitation, tremors, somnolence, psychosis, convulsions and coma have been associated with Zovirax IV for Infusion therapy, usually in medically complicated cases.

 

The frequency categories associated with the adverse events below are estimates. For most events, suitable data for estimating incidence were not available. In addition, adverse events may vary in their incidence depending on the indication.

The following convention has been used for the classification of undesirable effects in terms of frequency: Very common ³1/10, common ³1/100 and <1/10, uncommon ³1/1000 and <1/100, rare ³1/10,000 and <1/1000, very rare <1/10,000.

 

Blood and lymphatic system disorders

Uncommon:    Decreases in haematological indices (anaemia, thrombocytopenia, leukopenia)

Immune system disorders

Very rare:       Anaphylaxis

Psychiatric and nervous system disorders

Very rare:       Headache, dizziness, agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma.

The above reversible events are usually seen in medically complicated cases.

Vascular disorders

Common:        Phlebitis.

Respiratory, thoracic and mediastinal disorders

Very rare:       Dyspnoea.

Gastrointestinal disorders

Common:        Nausea, vomiting.

Very rare:       Diarrhoea, abdominal pain.

Hepato-biliary disorders

Common:        Reversible increases in liver-related enzymes.

Very rare:       Reversible increases in bilirubin, jaundice, hepatitis.

Skin and subcutaneous tissue disorders

Common:        Pruritus, urticaria, rashes (including photosensitivity).

Very rare:       Angioedema.

Renal and urinary disorders

Common:        Increases in blood urea and creatinine.

Rapid increases in blood urea and creatinine levels are believed to be related to the peak plasma levels and the state of hydration of the patient. To avoid this effect the drug should not be given as an intravenous bolus injection but by slow infusion over a one-hour period.

Very rare:       Renal impairment, acute renal failure.

Adequate hydration should be maintained. Renal impairment usually responds rapidly to rehydration of the patient and/or dosage reduction or withdrawal of the drug. Progression to acute renal failure, however, can occur in exceptional cases.

General disorders and administration site conditions

Very rare:       Fatigue, fever, local inflammatory reactions.

Severe local inflammatory reactions sometimes leading to breakdown of the skin have occurred when Zovirax I.V. for Infusion has been inadvertently infused into extracellular tissues.

 
 
 

5.3 Preclinical Safety Data

 

There is no information on the effect of aciclovir oral formulations or i.v. for infusion on human female fertility. In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

 

NON-CLINICAL INFORMATION

      Mutagenicity

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that acyclovir does not is unlikely to pose a genetic risk to man.

 

      Carcinogenicity

Aciclovir was not found to be carcinogenic in long-term studies in the rat and the mouse.

 

      Fertility

Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at systemic doses of aciclovir greatly in excess of those employed therapeutically. Two-generation studies in mice did not reveal any effect of (orally administered) aciclovir on fertility.

Updated on 9 March 2007 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 18 October 2006 PIL

Reasons for updating

  • Change of manufacturer

Updated on 4 August 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 22 November 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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