국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15ug (A/Singapore/GP1908/2015, IVR-180); Influenza virus A/Switzerland/8060/2017 (H3N2) like strain 15ug (A/Brisbane/1/2018, NYMC X-311); Influenza virus B/Colorado/06/2017 - like strain 15ug (B/Maryland/15/2016, NYMC BX-69A (Victoria lineage)); Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013, wild type (Yamagata lineage))
GlaxoSmithKline NZ Limited
Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15 µg (A/Singapore/GP1908/2015, IVR-180))
0.5 mL
Suspension for injection
Active: Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15ug (A/Singapore/GP1908/2015, IVR-180) Influenza virus A/Switzerland/8060/2017 (H3N2) like strain 15ug (A/Brisbane/1/2018, NYMC X-311) Influenza virus B/Colorado/06/2017 - like strain 15ug (B/Maryland/15/2016, NYMC BX-69A (Victoria lineage)) Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013, wild type (Yamagata lineage)) Excipient: D-alpha-Tocopheryl acid succinate Dibasic sodium phosphate dodecahydrate Magnesium chloride hexahydrate Monobasic potassium phosphate Octoxinol Polysorbate 80 Potassium chloride Sodium chloride Water for injection
Prescription
GlaxoSmithKline Biologicals (Dresden)
Fluarix Tetra is a quadrivalent vaccine indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by the influenza virus types A and B contained in the vaccine. The use of Fluarix Tetra should be based on official recommendations.
Package - Contents - Shelf Life: Syringe, glass, + steel injection needles - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, + steel injection needles - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2014-05-02
FLUARIX TETRA 1 FLUARIX TETRA _Inactivated Split Influenza Vaccine _ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about FLUARIX TETRA vaccine. 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 possible risks of you or your child having FLUARIX TETRA against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING FLUARIX TETRA TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again. WHAT FLUARIX TETRA IS USED FOR FLUARIX TETRA is used to help prevent certain types of influenza. The vaccine works by causing the body to produce its own protection (antibodies) against four different types of influenza virus. The types of influenza antigen contained in FLUARIX TETRA may change from one year to another. Each year, the Australian Influenza Vaccine Committee (AIVC) recommends which ones to include. This decision is based on the types of influenza virus thought most likely to occur during the next flu season. Therefore, influenza vaccination is recommended every year. PLEASE NOTE THAT FLUARIX TETRA WILL ONLY PROTECT YOU AGAINST THE FOUR TYPES OF INFLUENZA VIRUS USED TO MAKE THE VACCINE. IT WILL NOT PROTECT YOU FROM INFLUENZA CAUSED BY OTHER TYPES OF INFLUENZA VIRUS OR FROM INFECTIONS WITH OTHER AGENTS CAUSING FLU-LIKE SYMPTOMS (SUCH AS THE COMMON COLD). FLUARIX TETRA cannot give you or your child influenza because the viruses in the vaccine have been killed. Influenza is an infectious illness and is spread by small droplets from the nose, throat or mouth of an infected person. The most common symptoms of influenza include fever, sore throat, runny nose, coughing, general aches and pains, headache, weakness and tiredness, Most people recover completely within a week. The risk of serious complications (e.g. pneumonia and death) is greater in very y 전체 문서 읽기
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME FLUARIX TETRA Quadrivalent influenza vaccine (split virion, inactivated) 0.5 mL suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FLUARIX TETRA is an inactivated and purified split influenza vaccine. The antigen composition and strains for the 2019 influenza season corresponds to the following types: A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Singapore/GP1908/2015, IVR- 180) A/Switzerland/8060/2017 (H3N2) – like strain (A/Brisbane/1/2018, NYMC X-311) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type) B/Colorado/06/2017 – like strain (B/Maryland/15/2016, NYMC BX-69A) FLUARIX TETRA is prepared using whole virus cultivated in embryonated hens' eggs. The virus is concentrated and purified by clarification, adsorption and centrifugation. The purified whole virus is then treated with the detergent sodium deoxycholate and again centrifuged, and the resulting antigen suspension is inactivated with formaldehyde. Each 0.5 mL vaccine dose contains 15 µ g haemagglutinin of each of four influenza strains in phosphate buffered saline. May contain residual amounts of the following process related impurities: hydrocortisone, gentamicin sulphate, ovalbumin, formaldehyde, and sodium deoxycholate. The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. FLUARIX TETRA meets the WHO requirements for biological substances and influenza vaccines and the European Pharmacopoeia requirements for influenza vaccines. The type and amount of viral antigens in FLUARIX TETRA conform to the annual requirements of the Australian Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of Health. For full list of excipients see section 6.1 List of excipients. 2 3. PHARMACEUTICAL FORM FLUARIX TETRA is a colourless to slightly opalescent suspension. 4. CLINICAL PARTICUL 전체 문서 읽기