Country: নিউ জিলণ্ড
ভাষা: ইংরেজি
সূত্র: Medsafe (Medicines Safety Authority)
Varicella-zoster virus, Oka/Merck strain, live, attenuated 19400 PFU;
Merck Sharp & Dohme (New Zealand) Limited
Varicella vaccine 19400 PFU
19400 PFU
Injection with diluent
Active: Varicella-zoster virus, Oka/Merck strain, live, attenuated 19400 PFU Excipient: Dibasic sodium phosphate monohydrate Gelatin Monobasic potassium phosphate Monosodium glutamate Potassium chloride Sodium chloride Sucrose Urea Water for injection
Combination pack, 1 dose unit
Prescription
Prescription
Merck Sharp & Dohme Corp
Zostavax is indicated for: · prevention of herpes zoster (shingles)
Package - Contents - Shelf Life: Combination pack, vial + diluent syringe - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, vial + diluent vial - 1 dose units - 18 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, vial + diluent syringe - 10 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, - 1 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, diluent - 1 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, Active ingredient - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 minutes reconstituted stored at or below 25°C
2005-07-11
ZOSTAVAX ® _Zoster Vaccine Live (Oka/Merck) _ _Refrigerator stable_ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ZOSTAVAX. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines and vaccines have risks and benefits. Your doctor has weighed the risks of you being given ZOSTAVAX against the benefits they expect it will have for you. If you have any concerns about being given this vaccine, ask your doctor. Keep this leaflet with the medicine. You may need to read it again. WHAT ZOSTAVAX IS USED FOR Your doctor has recommended or administered ZOSTAVAX to prevent shingles (also known as zoster). ZOSTAVAX is an injectable live virus vaccine that is used to prevent shingles. Shingles is a painful, blistering rash that may result in scarring. The blisters can persist for several weeks. They often break out in one part of the body. The nerve pain that comes from shingles can last for months or even years after the rash heals. Shingles is caused by the same virus that causes chickenpox. After your chickenpox blisters heal, the virus that caused them stays in your body in nerve cells. The virus may be there for many years and not cause a problem. Sometimes, though, it becomes active again. If this happens, it can cause a blistering and painful rash. If you do get shingles even though you have been vaccinated, ZOSTAVAX can help prevent the long-lasting nerve pain that can follow shingles. ZOSTAVAX can also reduce the intensity and length of time your pain from shingles will last. ZOSTAVAX cannot be used to treat existing shingles or the pain associated with existing shingles. ZOSTAVAX can be administered at the same time as inactivated influenza vaccine. ZOSTAVAX is used in adults 50 years of age or older. ZOSTAVAX boosts your immune system to help protect you from shingles. As with any vaccine, ZOSTAVAX may not protect all people who receive the vaccine. BEFORE YOU ARE GIVEN ZOSTAVAX WHEN YOU SHOULD NOT BE GIVEN IT সম্পূর্ণ নথি পড়ুন
1 1 PRODUCT NAME ZOSTAVAX ® Zoster Vaccine Live (Oka/Merck) Refrigerator stable 2 QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution with accompanying vial or pre-filled syringe of diluent, 1 dose (0.65 mL) contains a minimum of 19,400 PFU (plaque forming units) of the Oka/Merck strain of varicella-zoster virus (VZV). For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Injection with diluent 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZOSTAVAX is indicated for: • prevention of herpes zoster (shingles) • prevention of postherpetic neuralgia (PHN) • reduction of acute and chronic zoster-associated pain. ZOSTAVAX is indicated for immunisation of individuals 50 years of age or older. 4.2 DOSE AND METHOD OF ADMINISTRATION For subcutaneous administration. Do not inject intravenously. Individuals should receive a single dose. ZOSTAVAX is not a treatment for zoster or PHN. ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine using separate syringes. Reconstitute immediately upon removal from the refrigerator. To reconstitute the vaccine, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine virus. Vial of diluent: To reconstitute the vaccine, first withdraw the entire contents of the diluent vial into a syringe. Inject all of the diluent in the syringe into the vial of lyophilised vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into a syringe and inject the total 2 volume of reconstituted vaccine subcutaneously, preferably into the upper arm (preferably in the deltoid region). Prefilled syringe of diluent: To reconstitute the vaccine, inject all the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into a syringe and inject the total volume of reconstituted vaccine subcutaneously, preferably into the upper arm (preferably in the deltoid region). IT IS RECOMMENDED THAT THE VAC সম্পূর্ণ নথি পড়ুন