Company: Sanofi Pasteur MSD.
Legal category: Prescription. Sport permitted.
Active ingredient: Live, attenuated varicella-zoster virus (Oka/Merck strain) ≥19400 PFU per 0.65ml.
Description: Powder and solvent for suspension for injection in pre-filled syringe.
Presentation: Vial and prefilled syringe, price available on request.
Indications: Prevention of herpes zoster (shingles) and herpes zoster-related post-herpetic neuralgia in adults over 50 years.
Pharmacology: Live, attenuated varicella-zoster virus (VZV) boosts VZV-specific immunity.
Dosage: Adult: 0.65ml single dose, by subcutaneous injection in deltoid region. Children: Not recommended.
Contraindications: Hypersensitivity to the active substance, any of the excipients or neomycin. Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukaemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/AIDS; cellular immune deficiencies. Active untreated tuberculosis. Pregnancy (avoid for 1 month afterwards).
Special precautions: Do not inject intravascularly. Consider deferral if fever present. Safety and efficacy not established in adults with HIV. Transmission of vaccine virus may occur (assess risk/benefit). Lactation.
Drug interactions: Contraindicated: Immunosuppressive therapy (including high-dose corticosteroids), excluding topical/inhaled corticosteroids or low-dose systemic corticosteroids or corticosteroids as replacement therapy (e.g. for adrenal insufficiency). Not recommended: 23-valent pneumococcal polysaccharide vaccine.
Adverse drug reactions: Headache, pain in extremity, injection site reactions (erythema, pain/tenderness, swelling, pruritus, haematoma, warmth, induration).
Full prescribing information and references available from Sanofi Pasteur MSD. Telephone: (01) 4685600. Fax: (01) 4203588. E-mail: medinfo@spmsd.com.
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