Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15ug (A/Singapore/GP1908/2015, IVR-180); Influenza virus A/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain 15ug (A/Singapore/INFIMH-16-0019/2016, NIB-104); Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013, wild type)
Viatris 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/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain 15ug (A/Singapore/INFIMH-16-0019/2016, NIB-104) Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013, wild type) Excipient: Calcium chloride dihydrate Dibasic sodium phosphate dihydrate Magnesium chloride hexahydrate Monobasic potassium phosphate Potassium chloride Sodium chloride Water for injection
Syringe, glass, single dose x, 1 dose unit
Prescription
Prescription
Abbott Biologicals BV
For the prevention of influenza virus, types A and B in adults and children older than 6 months in accordance with the recommendations in the National Immunisation Guideline.
Package - Contents - Shelf Life: Syringe, glass, single dose - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, single dose - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2003-04-28
Page 1 of 3 NEW ZEALAND CONSUMER MEDICINE INFORMATION INFLUVAC ® _INACTIVATED INFLUENZA VACCINE _ _SUSPENSION FOR INJECTION 15/15/15 MICROGRAM PER 0.5 ML _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Influvac. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you having Influvac against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT INFLUVAC IS USED FOR Influvac is used to prevent certain types of influenza (commonly called flu). The vaccine works by causing the body to produce its own protection (antibodies) against three different types of influenza virus. Each year new types of influenza virus can appear, so every year Influvac is changed to contain fragments of the new types of virus. Therefore, influenza vaccination is recommended every year. PLEASE NOTE THAT INFLUVAC WILL ONLY PROTECT YOU AGAINST THE THREE 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). Influenza is an infectious illness. Influenza is spread by small droplets from the nose, throat or mouth of an infected person. Symptoms of influenza begin 48 hours after coming into contact with the virus. These consist of chills, fever, generalised aches and pains, headache and respiratory symptoms (sore throat, runny nose, cough). The severity and type of symptoms can vary. Most people recover completely within a week. The risk of serious complications (e.g. pneumonia and death) is greater in very young, very old and chronically ill persons. Influvac can be used in adults and in children over the age of 6 months. For full details regarding recommendat Baca dokumen lengkapnya
Page 1 of 7 NEW ZEALAND DATA SHEET INFLUVAC ® _ _ 1. PRODUCT NAME Influvac, 45 microgram haemagglutinin per 0.5 mL, Suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influvac is a purified, inactivated influenza vaccine (surface antigen), each 0.5 mL of which contains antigens representative of the following type: A/Michigan/45/2015 (H1N1)pdm09-like strain 15 microgram haemagglutinin/dose (A/Singapore/GP1908/2015, IVR-180) A/Singapore/INFIMH-16-0019/2016 (H3N2)-like strain 15 microgram haemagglutinin/dose (A/Singapore/INFIMH-16-0019/2016, NIB-104) B/Phuket/3073/2013-like strain 15 microgram haemagglutinin/dose (B/Phuket/3073/2013, wild type) For the full list of excipients, see section 6.1. Influvac antigens have been produced from eggs and is inactivated by formaldehyde treatment. Each 0.5 mL may also contain not more than 100 ng ovalbumin, 0.01 mg formaldehyde, 15 microgram cetrimonium bromide, 1 mg sodium citrate, 0.2 mg sucrose, 1 ng gentamicin sulfate, traces of tylosine tartrate, hydrocortisone and polysorbate 80 which are used during the manufacturing process. 3. PHARMACEUTICAL FORM Influvac is a clear colourless suspension for injection. It is an egg-grown, inactivated influenza virus vaccine based on isolated surface antigens of A and B strains of myxovirus influenza. The type and amount of viral antigens in Influvac conform to the requirements of the Australian Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of Health for the winter of 2018. The strains chosen for vaccine manufacture are endorsed by the AIVC as being antigenically equivalent to the reference virus. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ For the prevention of influenza caused by influenza virus, types A and B in adults and children older than 6 months in accordance with the recommendations in the National Immunisation Guideline. _4.2 _ _DOSE AND METHOD OF ADMINISTRATION _ DOSE Page 2 of 7 One dose is sufficient for persons previously exposed to viruses of similar antigenic compositio Baca dokumen lengkapnya