Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
Influenza virus haemagglutinin, Quantity: 15 microgram
Seqirus Pty Ltd
Injection, suspension
Excipient Ingredients: monobasic potassium phosphate; magnesium chloride hexahydrate; sorbitan trioleate; squalene; sodium citrate dihydrate; citric acid monohydrate; calcium chloride dihydrate; potassium chloride; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; polysorbate 80
Intramuscular
Prefilled syringe needle free, 1 x 0.5 mL, Prefilled syringe needle free, 10 x 0.5 mL
(S4) Prescription Only Medicine
Active immunisation against influenza in persons 65 years of age and older.
Visual Identification: Milky-white suspension; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-10-01
Fluad Quad 1 FLUAD® QUAD CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor, nurse or pharmacist. 1. WHY AM I USING FLUAD® QUAD? Fluad® Quad contains the active ingredient influenza virus haemagglutinin. Fluad® Quad is a vaccine used to help prevent certain types of influenza or “flu”. It is for use in people aged 65 years and older only. For more information, see Section 1. Why am I using Fluad® Quad? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE BEING GIVEN FLUAD® QUAD? Tell your doctor, nurse or pharmacist if you have ever had a severe allergic reaction to Fluad® Quad or any of the ingredients listed at the end of the CMI or any other influenza vaccines. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS OR TAKE ANY OTHER MEDICINES. For more information, see Section 2. What should I know before being given Fluad® Quad? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Fluad® Quad and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS FLUAD® QUAD GIVEN? Fluad® Quad is given as an injection usually into your shoulder muscle by a doctor, nurse or pharmacist. More instructions can be found in Section 4. How is Fluad® Quad given? in the full CMI. 5. WHAT SHOULD I KNOW ABOUT BEING GIVEN FLUAD® QUAD? THINGS YOU SHOULD DO Call your doctor straight away if you do not feel well after having Fluad® Quad. Keep an updated record of your vaccinations. Keep any follow-up appointments with your doctor or clinic. For more information, see Section 5. What should I know about being given Fluad® Quad? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? Common side effects may include local reaction around the injection site, fatigue and headache. Mostly these are mild and usually disappear within 3 days without treatment. Serious side effects are rare. Sudden signs of allergy may be Lestu allt skjalið
Seqirus Fluad ® Quad AUST R 313724 & AUST R 316323 Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION FLUAD ® QUAD (INFLUENZA VIRUS HAEMAGGLUTININ) 1. NAME OF THE MEDICINE FLUAD ® QUAD Inactivated quadrivalent influenza vaccine (surface antigen), adjuvanted, suspension for injection; containing Influenza virus haemagglutinin as active ingredient. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mL dose contains influenza virus surface antigens (haemagglutinin and neuraminidase) of each of four antigens representative of the influenza virus types expected to circulate in the Southern Hemisphere winter according to WHO recommendations for the 2022 season: - A/Victoria/2570/2019 (H1N1)pdm09-like virus (A/Victoria/2570/2019 IVR-215): 15 micrograms HA* per dose - A/Darwin/9/2021 (H3N2)-like virus (A/Darwin/6/2021 IVR-227): 15 micrograms HA* per dose - B/Austria/1359417/2021-like virus (B/Austria/1359417/2021 BVR-26): 15 micrograms HA* per dose - B/Phuket/3073/2013-like virus (B/Phuket/3073/2013 BVR-1B): 15 micrograms HA* per dose *HA = haemagglutinin Fluad ® Quad vaccine is prepared from virus grown in embryonated hens’ eggs and inactivated with formaldehyde before purification and combination with MF59C.1, an adjuvant known to increase the immunogenicity of vaccines. MF59C.1 adjuvant is a squalene based oil-in-water emulsion. Squalene is of fish origin. It is also a normal component in the human body and is easily metabolized and excreted. For a full list of excipients, see SECTION 6.1 – LIST OF EXCIPIENTS . The type and amount of viral antigens in Fluad ® Quad conform to the requirements of the Australian Influenza Vaccine Committee for the 2022 Southern Hemisphere Influenza season. The strains chosen for vaccine manufacture are endorsed by the Australian Influenza Vaccine Committee as being antigenically equivalent to the reference virus. Seqirus Fluad ® Quad AUST R 313724 & AUST R 316323 Page 2 of 15 Fluad ® Quad is manufactured in eggs and trace amounts of kanamycin sulfate, neomycin sulfate, ovalbumin ( Lestu allt skjalið