ZOSTAVAX Powder and solvent for suspension for injection (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

ZOSTAVAX powder and solvent for suspension for injection. ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe. shingles (herpes zoster) vaccine (live)

Qualitative and quantitative composition

After reconstitution, 1 dose (0.65 mL) contains: Varicella-zoster virus1, Oka/Merck strain, (live, attenuated) not less than 19,400 PFU2. 1 produced in human diploid (MRC-5) ...

Pharmaceutical form

Powder and solvent for suspension for injection. The powder is a white to off-white compact crystalline plug. The solvent is a clear, colourless fluid.

Therapeutic indications

ZOSTAVAX is indicated for prevention of herpes zoster (zoster or shingles) and herpes zoster-related post-herpetic neuralgia (PHN). ZOSTAVAX is indicated for immunization of individuals 50 years of age ...

Posology and method of administration

Posology Individuals should receive a single dose (0.65 mL). The need for a booster dose is not known. See sections 4.8 and 5.1. Paediatric population The safety and efficacy of ZOSTAVAX in children and ...

Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or neomycin (which may be present as trace residues, see sections 2 and 4.4). Primary and acquired immunodeficiency ...

Special warnings and precautions for use

Traceability In order to improve the traceability ofbiological medicinal products, the name and the batch number of the administered product should be clearly recorded. Appropriate medical treatment and ...

Interaction with other medicinal products and other forms of interaction

ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine as separate injections and at different body sites (see section 5.1). The concomitant use of ZOSTAVAX and a 23-valent pneumococcal ...

Fertility, pregnancy and lactation

Pregnancy There are no data on the use of ZOSTAVAX in pregnant women. Traditional non-clinical studies are insufficient with respect to reproductive toxicity (see section 5.3). However naturally-occurring ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive or use machines have been performed. However, ZOSTAVAX is expected to have no or negligible influence on ability to drive and use machines.

Undesirable effects

a. Summary of the safety profile The most common adverse reactions reported in pivotal clinical trials were injection-site reactions. Headache and pain in the extremity were the most common systemic adverse ...

Overdose

Administration of a higher than recommended dose of ZOSTAVAX was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of ZOSTAVAX.

Pharmacodynamic properties

Pharmacotherapeutic group: Vaccines, Viral Vaccine ATC code: J07BK02 Mechanism of action Anyone who has been infected with VZV, including those without a clinical history of varicella, is at risk for developing ...

Pharmacokinetic properties

Not applicable.

Preclinical safety data

Traditional non-clinical studies were not performed, but there are no non-clinical concerns considered relevant to clinical safety beyond data included in other sections of the Summary of Product Characteristics ...

List of excipients

Powder: Sucrose Hydrolysed gelatin Sodium chloride Potassium dihydrogen phosphate Potassium chloride Monosodium L-glutamate monohydrate Disodium phosphate Sodium hydroxide (to adjust pH) Urea Solvent: ...

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

18 months. After reconstitution, the vaccine should be used immediately. However, in-use stability has been demonstrated for 30 minutes when stored at 20°C–25°C.

Special precautions for storage

Store and transport refrigerated (2°C–8°C). Do not freeze. Store in the original package in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section ...

Nature and contents of container

ZOSTAVAX with solvent for reconstitution supplied in a vial: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a vial (glass) with a stopper (chlorobutyl ...

Special precautions for disposal and other handling

Before mixing with the solvent, the powder vaccine is a white to off-white compact crystalline plug. The solvent is a clear colourless liquid. When reconstituted, ZOSTAVAX is a semi-hazy to translucent, ...

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization number(s)

EU/1/06/341/001 EU/1/06/341/002 EU/1/06/341/005 EU/1/06/341/006 EU/1/06/341/007 EU/1/06/341/008 EU/1/06/341/009 EU/1/06/341/010 EU/1/06/341/011 EU/1/06/341/012 EU/1/06/341/013

Date of first authorization / renewal of the authorization

Date of first authorisation: 19 May 2006 Date of latest renewal: 11 February 2016

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