País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Varicella vaccine 1350 PFU (Oka/Merck);
Merck Sharp & Dohme (New Zealand) Limited
Varicella vaccine 1350 PFU (Oka/Merck)
1350 PFU
Injection with diluent
Active: Varicella vaccine 1350 PFU (Oka/Merck) Excipient: Dibasic sodium phosphate dodecahydrate Gelatin Monobasic potassium phosphate Monosodium glutamate Potassium chloride Sodium chloride Sucrose Urea Water for injection
Combination pack, Vaccine + diluent, 1 dose unit
Prescription
Prescription
Merck Sharp & Dohme Corp
VARIVAX is indicated for vaccination against varicella in individuals 12 months of age and older.
Package - Contents - Shelf Life: Combination pack, Vaccine + diluent - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 150 minutes reconstituted stored between 20-25°C - Combination pack, 10 x vaccine + diluent - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 150 minutes reconstituted stored between 20-25°C - Vial, glass, single dose, Diluent - 0.7 mL - 24 months from date of manufacture stored at or below 25°C. (may be refrigerated but do not freeze) - Vial, glass, single dose, vaccine - 1350 PFU - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
1997-07-14
NEW ZEALAND CONSUMER MEDICINE INFORMATION VARIVAX ® _Varicella Virus Vaccine Live (Oka/Merck) _ Single dose vial WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VARIVAX. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines and vaccines have risks and benefits. Your doctor has weighed the risks of you being given VARIVAX against the benefits your doctor expects it will have for you. If you have any concerns about being given this vaccine, ask your doctor. Keep this leaflet. You may need to read it again. WHAT VARIVAX IS USED FOR VARIVAX is a vaccine used to help prevent chickenpox. It can be given to children 12 months of age and above, teenagers and adults. Chickenpox is easily passed from one person to another and occurs in millions of people worldwide each year, most often in children 5 to 9 years of age. It is primarily spread from person to person through the air by sneezing or coughing. Once a person has been infected, it usually takes about 2 to 3 weeks before symptoms start. Symptoms of chickenpox include mild headache, moderate fever, and general discomfort. These are followed by a rash of itchy, little red spots which usually start on the chest, stomach or back, but can appear anywhere on the body. There may be only a few spots or clusters of spots, or even hundreds of spots that develop over the next 3 to 5 days. The spots will change into clear blisters filled with fluid which then become cloudy, break open, dry, scab, and heal, usually within 5 to 20 days. Although chickenpox is generally a fairly harmless disease, it may be associated with serious complications and/or rarely death. In children, the most common complications are bacterial skin infections. Less frequent but very serious complications include pneumonia, inflammation of the brain (encephalitis), Reye syndrome, and death. Severe disease and serious complications are more likely to occur in adolescents and adults. BEFORE YOU ARE GIVEN VARIVAX WHEN Y Llegiu el document complet
Page 1 of 13 NEW ZEALAND DATA SHEET 1. PRODUCT NAME VARIVAX ® Varicella Virus Vaccine Live (Oka/Merck) 0.5 mL single dose vial 2. QUALITATIVE AND QUANTITATIVE COMPOSITION VARIVAX is live, attenuated virus vaccine (a lyophilised preparation of the Oka/Merck strain of varicella). Each 0.5 mL dose of VARIVAX contains: a minimum of 1350 PFU (plaque forming units) of Oka/Merck varicella virus when reconstituted as directed and stored at room temperature for 150 minutes. The product also contains residual components of MRC-5 cells and trace quantities of neomycin and bovine calf serum from MRC-5 culture media. The product contains no preservative. For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder and solvent for suspension for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VARIVAX is indicated for vaccination against varicella in individuals 12 months of age and older. 4.2 DOSE AND METHOD OF ADMINISTRATION FOR SUBCUTANEOUS ADMINISTRATION Do not inject intravenously. Children 12 months to 12 years of age should receive a 0.5 mL dose administered subcutaneously. A second dose of VARIVAX administered at least 3 months later is recommended to ensure optimal protection against varicella (see Section 5 PHARMACOLOGICAL PROPERTIES). Adolescents and adults 13 years of age and older should receive a 0.5 mL dose administered subcutaneously at elected date and a second 0.5 mL dose 4 to 8 weeks later. The outer aspect of the upper arm (deltoid region) is the preferred site of injection. For instructions on reconstitution of VARIVAX before administration, see section 6.6. Page 2 of 13 4.3 CONTRAINDICATIONS History of hypersensitivity to any component of the vaccine, including gelatin. History of anaphylactoid reaction to neomycin (each dose of reconstituted vaccine contains trace quantities of neomycin). Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. Immunosuppressive therapy (including high-dose corticosteroids Llegiu el document complet