ZOSTAVAX
- Name:
ZOSTAVAX
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/12/20
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MSD Ireland (Human Health) Limited
Company Products
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 16 December 2020 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
Deletion of pack sizes with attached needles in section 6.5 and deletion of corresponding EU numbers in section 8.
Updated on 16 December 2020 PIL
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 15 October 2020 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- 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
- Section 4.3: updated wording on hypersensitivity
- Section 4.4: added headings for “Traceability”, “Sodium” and “Potassium”
- Section 6.6: added product description (before and after reconstitution) and updated reconstitution instructions
Updated on 15 October 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product looks like and pack contents
- Change to information for healthcare professionals
Updated on 25 March 2020 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 27 February 2019 PIL
Reasons for updating
- Change to further information section
Updated on 25 January 2019 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 25 January 2019 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Update on concomitant use of ZOSTAVAX and a 23-valent pneumococcal polysaccharide
Updated on 3 September 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
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 17 January 2018 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 9 - Date of first authorisation/renewal of the 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 9: updated renewal date
Updated on 17 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 30 August 2017 SPC
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
Updated on 3 March 2017 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
Updated on 2 March 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 2 March 2017 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 17 January 2017 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 25 February 2016 SPC
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 4.8 - Undesirable effects
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4: Included 'ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration may result in disseminated disease in individuals who are immunosuppressed or immunodeficient. Patients who previously received immune suppressive therapy should be carefully evaluated for the reconstitution of the immune system prior to receiving Zostavax (see section 4.3)'.
'The safety and efficacy of ZOSTAVAX have not been established in adults who are known to be infected with HIV with or without evidence of immunosuppression (see section 4.3) however, a phase II safety and immunogenicity study in HIV-infected adults with conserved immune function (CD 4+T cell count ≥ 200 cells/µL) has been completed (see sections 4.8 and 5.1)'.
Section 4.5: Addition of sentence 'Therefore, administration of the two vaccines should be considered to be separated by at least 4 weeks'.
Section 4.8: Addition of 'Eye disorders Necrotizing retinitis (patients on immunosuppressive therapy) – Very rare'.
Section 9: Date of first authorisation and Renewal amended
Section 10: date revised to 02/2016Updated on 25 February 2016 PIL
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 7 January 2016 SPC
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 4.4 - 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
- 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: reflects both combinations
Section 2: QRD formatted
Section 4.2: QRD + addition of IM use and the statement "The vaccine should be administered subcutaneously in patients with severe thrombocytopenia or any coagulation disorder (see section 4.4)". Also added the statement "The vaccine should under no circumstances be injected intravascularly".
Section 4.4: addition of IM use + statement "This vaccine should be given subcutaneously to individuals with severe thrombocytopenia or any coagulation disorder, because these individuals may bleed following intramuscular injections". Also added "Immunisation should be postponed in individuals suffering from moderate to severe acute febrile illness or infection".
Section 4.6: aligned with the QRD format
Section 4.8: QRD format + frequency changes from not known to rare
Section 5.1: Clinical Efficacy and Data updated, addition of statement "The European Medicines Agency has waived the obligation to submit the results of studies with ZOSTAVAX in all the subsets of paediatric population (see section 4.2 for information on paediatric use)".
Section 6.1: updated 2 excipients to read:
Monosodium L-glutamate monohydrate
Disodium phosphate
Section 6.5 + 6.6: Updated to be combined vial + pre-filled syringe
Section 10:
Date revised to 12/2015
Updated on 7 January 2016 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 11 May 2015 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
In section 4.2 amended text to read 'The need for a booster dose is not known'
In section 4.8 add P029 study results (booster dose), include adverse reaction reporting information
In section 5.1 add P029 study results (Immunogenicity in Subjects Receiving a Booster Dose)
In section 10, date of revision 04/2015
Updated on 8 December 2014 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 4.8 addition of HIV-infected adults with conserved immune function data
Section 5.1 addition of Immunogenicity in HIV-infected adults with conserved immune function
Section 10 date of last revision updated from 10/2014 to 11/2014
Updated on 18 November 2014 PIL
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 18 November 2014 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
In section 4.8, herpes zoster has been added. Information contacts on reporting of suspected adverse reactions have also been added.
In section 6.6, reconstitution part has been re-worded.
In section 10, revision date has been updated to 10/2014.
Updated on 31 March 2014 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 31 March 2014 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)