VARIVAX

  • Name:

    VARIVAX

  • Company:
    info
  • Active Ingredients:

    Varicella-zoster virus (live)

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/02/19

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Summary of Product Characteristics last updated on medicines.ie: 22/11/2018

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

Company Products

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Medicine Name Cerazette 75 microgram film-coated tablet Active Ingredients Desogestrel
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Medicine Name Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Losartan potassium
Medicine Name Cubicin 350mg Powder for Solution for injection or infusion Active Ingredients Daptomycin
Medicine Name Cubicin 500mg powder for solution for injection or infusion Active Ingredients Daptomycin
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Medicine Name Elocon Ointment Active Ingredients Mometasone Furoate
Medicine Name Elocon Scalp Lotion Active Ingredients Mometasone Furoate
Medicine Name EMEND 125 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80mg, 125mg hard Capsules Active Ingredients Aprepitant
Medicine Name Esmeron Active Ingredients Rocuronium Bromide
Medicine Name EZETROL 10 mg Tablets Active Ingredients ezetimibe
Medicine Name FOSAMAX Once Weekly 70 mg Tablets Active Ingredients Alendronate Sodium Trihydrate
Medicine Name FOSAVANCE Active Ingredients Alendronate Sodium Trihydrate, Colecalciferol (Vitamin D3)
Medicine Name GARDASIL Active Ingredients human papillomavirus vaccine
1 - 0 of 84 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 15 February 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 22 November 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 22 November 2018 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: Addition of text: “Complications of varicella from vaccine strain, including herpes zoster and disseminated disease such as aseptic meningitis and encephalitis, have been reported in immunocompromised or immunocompetent individuals.”

Updated on 14 August 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section

Updated on 8 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 8 January 2018 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

In section 1, hard brackets around "Varicella Vaccine (live)" have been removed.
Editorial changes have been made to other sections.

Updated on 5 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 January 2018 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 2 March 2017 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

SPC change details: New Marketing Authorisation Holder and MA Number following PA transfer to Merck Sharp & Dohme Ireland (Human Health) Limited

Updated on 1 March 2017 PIL

Reasons for updating

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

Updated on 3 March 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 7 February 2014 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

Reporting of suspected adverse reactions paragraph has been updated following comment from the IMB after publishing the SPC following the approval of the variation.

Updated on 31 January 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 2 January 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.2 - Incompatibilities

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

Free text change information supplied by the pharmaceutical company

section 2: editorial change
section 4.5: editorial change
section 4.8: addition of the text "Necrotizing retinitis has been reported post-marketing in immunocompromised individuals."

and the description of reporting process for suspected adverse reactions in Ireland

section 6.2: replacement of "should" by "must".

Updated on 12 July 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 11 July 2013 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 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 main changes to the SPC are as follows:

 

Section 4.3 Contraindications

The updated text (see below) clarifies the fact that that the contraindication applies to individuals with severe humoral or cellular immunodeficiency:

 

Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see section 4.4).

 

 

The contraindication below has been expanded to include the fact that pregnancy should be avoided for 1 month following vaccination:

 

Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination (see section 4.6).

 

 

Section 4.4 Special warnings and precautions for use

Information on the use of the product in children with HIV infection has now been moved to section 4.3 Contraindications (see above).

Section 4.4 has also been updated (see updated text below) to include patients with selected immune deficiencies and clarification added about immunocompromised patients receiving the vaccine .

 

Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (e.g., asymptomatic HIV subjects, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).

 

Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent subjects; therefore, some of these patients may acquire varicella in case of contact, despite appropriate vaccine administration. These patients should be monitored carefully for signs of varicella.

 

 

The sub-heading, ‘Pregnancy and breastfeeding’ has been deleted and the information associated with the heading has now been moved to sections 4.3 Contraindications and 4.6 Fertility, pregnancy and lactation.

 

 

Section 4.6 Fertility, pregnancy and lactation

This section has been updated (see updated text below) to clarify that pregnant women should not be vaccinated with the product.

 

Pregnancy

Pregnant women should not be vaccinated with VARIVAX.

 

Studies have not been conducted with VARIVAX in pregnant women.

However, fetal damage has not been documented when varicella vaccines have been given to pregnant women.It is not known whether VARIVAX can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.

 

Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay.

 

 

Date of revision in Section 10 has been changed to June 2013.

Updated on 7 December 2012 SmPC

Reasons for updating

  • 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

the SPc has been updated with long-term effectiveness data as follows:


Section 4.8 Undesirable effects
The following sentence has been deleted from section 4.8 (Undesirable effects) section c Description of adverse events:

The long-term effect of varicella vaccine (live) (Oka/Merck strain) on the incidence of herpes zoster, particularly in those vaccinees exposed to wild-type varicella, is unknown at present.


The following text has been added to section 4.8 (Undesirable effects) section c Description of adverse events:

Active surveillance data in children vaccinated with varicella vaccine (live) (Oka/Merck strain) and followed for 14 years after vaccination showed no increase in the frequency of herpes zoster compared to children with prior wild-type varicella during the pre-vaccine era. However, the long-term effect of varicella vaccine (live) (Oka/Merck strain) on the incidence of herpes zoster is unknown at present (see section 5.1).


Section 5.1 Pharmacodynamics
The following text has been added at the end of this section:

Effectiveness of varicella vaccine (live) (Oka/Merck strain)

 

Observational studies of long-term effectiveness of VARIVAX

Surveillance data from two U.S. observational effectiveness studies confirmed that widespread varicella vaccination reduces the risk of varicella by approximately 90%. Furthermore, the reduced risk of varicella was maintained at the population level over at least 15 years both in vaccinated and unvaccinated individuals. The data also suggest that varicella vaccination may reduce the risk of herpes zoster in vaccinated individuals.

 

In the first study, a long-term prospective cohort study, approximately 7,600 children vaccinated in 1995 with varicella vaccine in their second year of life were actively followed for 14 years in order to estimate the occurrence of varicella and herpes zoster. By the end of the study in 2009, 38% of the study children were known to have received a second dose of varicella vaccine. Of note, in 2006, a second dose of varicella vaccine was recommended in the U.S. Over the entire follow-up, the incidence of varicella was approximately 10-fold lower among vaccinees than among children of the same age in the pre-vaccine era (estimated vaccine effectiveness over the study period was between 73% and 90%). Regarding herpes zoster, there were fewer herpes zoster cases among varicella vaccinees during the follow-up period than expected from rates in children of the same age with prior wild-type varicella during the pre-vaccine era (relative risk = 0.61, 95% CI 0.43 - 0.89). Breakthrough varicella and zoster cases were usually mild.

 

In a second long‑term surveillance study, five cross‑sectional surveys on varicella incidence, each from a random sample of approximately 8,000 children and adolescents 5 to 19 years of age, were conducted over 15 years, from 1995 (pre‑vaccine) through 2009. Results showed a gradual decline of varicella rates by an overall 90% to 95% (approximately 10‑ to 20‑fold) from 1995 to 2009 in all age groups, both in vaccinated and unvaccinated children and adolescents. In addition, a decrease by approximately 90% (approximately 10‑fold) in varicella hospitalization rates was observed in all age groups.

Updated on 2 November 2012 PIL

Reasons for updating

  • Change to date of revision
  • Changes to therapeutic indications

Updated on 1 November 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 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

4.1 Therapeutic indications

 

addition of a new paragraph:

 

VARIVAX can be administered to infants from 9 months of age under special circumstances, such as to conform with national vaccination schedules or in outbreak situations (see sections 4.2, 4.5, and 5.1).

 

4.2 Posology and method of administration

 

addition of a new paragraph: in Posology

 

The use of VARIVAX should be based on official recommendations.


Individuals less than 9 months of age

VARIVAX should not be administered to individuals less than 9 months of age.


Individuals from
9 months of age

Individuals should receive two doses of VARIVAX to ensure optimal protection against varicella (see section 5.1).

Individuals from 9 to 12 months of age

 

In settings in which vaccination is initiated between 9 and 12 months of age, a second dose is needed and should be given after a minimum interval of 3 months (see section 5.1).

Individuals from 12 months to 12 years of age

 

 For individuals from 12 months to 12 years of age, at least one month must elapse between the first and second dose (see section 5.1).

Addition of a new parapgraph and table in section 5.1 Pharmacodynamic properties

 

Updated on 27 July 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 26 July 2012 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

in section 4.8 (undesirable effects), nausea, vomiting and varicella (vaccine strain) have been added in sub-section post-marketing surveillance.

Updated on 20 July 2011 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 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • 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

As a reminder, the purpose of this variation is to update the Summary of Product Characteristics

(SmPC) of Varivax to refiect changes that have been made to the Company Core Datasheet (CCDS)

with respect to section 4.4 “Speciai warnings and precautions for use” and section 4.8 “Undesirabie

effects”, each under the subsection of “Transmission”. Additionaiiy, in section 4.8 “Undesirable

effects”, under the subsection of “Post-Marketing Surveiliance”, aplastic anemia has been added to

the Iist of adverse events;

Updated on 22 June 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 30 March 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

The wrong MA holder adress was in the SPC and the correct one has been submitted

Updated on 1 March 2011 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

change to tipcap

Updated on 15 February 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 16 February 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to dosage and administration
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to further information section
  • Change to date of revision

Updated on 12 February 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • 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

Change to section 2

Description of product updated

Change to section 3

Description of product updated

Change to section 4.1

Rewording of section,

Change to section 4.2

Introduction of 2 dose schedule, update to method of administration

Change to section 4.4

Reformatting of section.

Change to section 4.7

Reformatting of section

Change to section 4.8

Reformatting of section, addition of side effect observed following 2 dose regimen.

Change to section 5.1

Addition of data supporting 2 dose regimen. 

Change to section 6.2

Additional statement concerning reconstitution with other medicinal products.

Change to section 6.4

Reformatting of section

Change to section 6.6

Rewording of section.

Updated on 4 August 2008 SmPC

Reasons for updating

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

Section 4.2

Addition of intramuscular route of administration.  

Section 4.8

Update of information, following the addition if intramuscular route of administration - safety profile is comparable between intramuscular and subcutaneous routes of administration.

Section 5.1

Addition of information - Immunogenicity profile similar for both intramuscular and subcutaneous routes of administration.

Updated on 4 August 2008 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 28 November 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 31 May 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 17 April 2007 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

Section 7 - updated the address of the Marketing Authorisation Holder.

Section 10 - changed date of revision to March 2007

Updated on 9 June 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 April 2006 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 19 July 2005 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change to section 7 - Marketing authorisation holder

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

Updated on 27 April 2005 SmPC

Reasons for updating

  • New SPC for new product

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