Retrovir IV

  • Name:

    Retrovir IV

  • Company:
    info
  • Active Ingredients:

    Zidovudine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/02/19

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Summary of Product Characteristics last updated on medicines.ie: 26/2/2019

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ViiV Healthcare UK Ltd

ViiV Healthcare UK Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Celsentri film-coated tablets Active Ingredients Maraviroc
Medicine Name Combivir Film-Coated Tablets Active Ingredients Lamivudine, Zidovudine
Medicine Name Dovato 50 mg/300 mg film-coated tablets Active Ingredients Dolutegravir sodium
Medicine Name Epivir Film-Coated Tablets 150mg Active Ingredients Lamivudine
Medicine Name Epivir Film-Coated Tablets 300mg Active Ingredients Lamivudine
Medicine Name Epivir Oral Solution 10mg/ml Active Ingredients Lamivudine
Medicine Name Juluca 50 mg/25 mg film-coated tablets Active Ingredients Dolutegravir sodium, Rilpivirine Hydrochloride
Medicine Name Kivexa film-coated tablets Active Ingredients Abacavir Sulfate, Lamivudine
Medicine Name Retrovir Capsules 100mg Active Ingredients Zidovudine
Medicine Name Retrovir IV Active Ingredients Zidovudine
Medicine Name Retrovir Oral Solution Active Ingredients Zidovudine
Medicine Name Telzir 50mg/ml Oral Suspension Active Ingredients Fosamprenavir calcium
Medicine Name Telzir 700mg Film-Coated Tablets Active Ingredients Fosamprenavir calcium
Medicine Name Tivicay film-coated tablets Active Ingredients Dolutegravir sodium
Medicine Name Triumeq 50 mg/600 mg/300 mg film-coated tablets Active Ingredients Abacavir Sulfate, Dolutegravir sodium, Lamivudine
Medicine Name Trizivir Film-Coated Tablets Active Ingredients Abacavir Sulfate, Lamivudine, Zidovudine
Medicine Name Ziagen Film-Coated Tablets 300mg Active Ingredients Abacavir Sulfate
Medicine Name Ziagen Oral Solution 20mg/ml Active Ingredients Abacavir Sulfate
1 - 0 of 18 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 28 February 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 26 February 2019 SmPC

Reasons for updating

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

section 4.2, update to dosing
section 4.8, update to uk reporting information
 

Updated on 7 December 2018 PIL

Reasons for updating

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

Updated on 7 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)

Free text change information supplied by the pharmaceutical company

Section 7 with the MAH address and section 8 with the PA number

Updated on 23 November 2018 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

SmPC Section 4.4 Warnings:
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.

SmPC Section 4.8 Undesirable events:
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. (see section 4.4).

Updated on 14 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 February 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 22 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 22 May 2017 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 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • 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

Update to sections 4.6 and 5.3 of the SmPC in order to revise the wording regarding pregnancy to reflect current understanding of pharmacovigilance data.

Administrative corrections:
-Sections 4.3 and 4.4: 0.75 or 1.0 x 109/litre has been reformatted to 0.75 or 1.0 x 109/litre
- Section 4.8: 100/mm3 has been reformatted to 100/mm3
- Section 4.4: Added the word “or” between “rifampicin” and “stavudine” in the third paragraph.

Updated on 29 September 2016 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)

Free text change information supplied by the pharmaceutical company

Update section 4.4 of the SmPC in order to revise the wording regarding mitochondrial dysfunction following assessment of responses to a relevant LEG and after analysis of the final CSR of the Mitochondrial Toxicity in Children (MITOC) Study.

Updated on 28 September 2016 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 23 February 2016 SmPC

Reasons for updating

  • 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 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

Sections 4.4 & 4.8: Class labelling update following PRAC review on Lipodystrophy and Lactic Acidosis.

Administrative changes to all other sections.


Updated on 22 February 2016 PIL

Reasons for updating

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

Updated on 12 October 2015 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 5.1 of SmPC updated, specifically the antiviral activity in vitro antagonism statement

Updated on 27 May 2015 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

Breastfeeding update to section 4.6 SmPC

Updated on 26 May 2015 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 24 December 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

4.4 Add warning regarding viral suppression and deletion of Retrovir therapy.
 
4.8 Add contact details for reporting of adverse events.

Updated on 22 December 2014 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 27 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.3 – a reference to the excipients listed in section 6.1 has been added

Section 4.4 - additional wording added to Immune Reactivation Syndrome (IRIS)

Section 4.8 – Adverse event frequencies have been reformatted

Section 6.6 – “medicinal” added

Updated on 23 May 2014 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 8 November 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 8 November 2013 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Changes to:

Section 4.4 - Special warnings and precautions for use

Updated on 3 July 2012 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

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

Free text change information supplied by the pharmaceutical company

Amendment to section 4.4 of the SPC with information regarding exacerbation of anaemia in patients co-infected with HCV and receiving Ribavirin. Amendment to section 4.5 of the SPC to harmonise information on the interaction between Zidovudine and atovaquone.

Amendment to section 4.6 of the SPC to reflect the increased number of exposures during the first trimester of Zidovudine during pregnancy

Updated on 29 June 2012 PIL

Reasons for updating

  • Change to drug interactions

Updated on 30 January 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 7 October 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Change to:

Section 7 - MARKETING AUTHORISATION HOLDER

Updated on 11 March 2009 PIL

Reasons for updating

  • Change to how the medicine works
  • Change to dosage and administration

Updated on 23 January 2009 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

SPC Section 4.2 To update the paediatric dosage recommendation including the switch from body surface area (BSA)-based dosing (mg/m2) to body weight-based dosing (mg/kg), and the change from three times a day dosing to twice daily (BID) dosing.

SPC Section 4.2 + 5.2 To updated wording regarding administration and pharmacokinetics in patients with Renal impairment.

Updated on 26 August 2008 PIL

Reasons for updating

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

Updated on 27 March 2008 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • 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

Change to section 1 - trade name
Change to section 2 - qualitative and quantitative composition

Change to section 4.2 - Posology and Method of Administration
Change to section 4.3 - Contra-indications
Change to section 4.4 - Special Warnings and Precautions for Use
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction

Change to section 4.7 Effects on ability to drive and use machines

Change to section 4.8 - Undesirable Effects

Change to section 5.2 – Pharmokinetic Properties
Change to section 6.4 - Special Precautions for storage
Change to section 9 – Date Of First Authorisation/Renewal Of The Authorisation
Change to section 10  Date of (partial) revision of the text

Updated on 12 March 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 27 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 3 March 2005 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • 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

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

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)