Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
Influenza virus haemagglutinin, Quantity: 15 microgram
Seqirus Pty Ltd
Injection, suspension
Excipient Ingredients: sodium chloride; dibasic sodium phosphate; monobasic sodium phosphate; potassium chloride; monobasic potassium phosphate; calcium chloride dihydrate; water for injections
Intramuscular, Subcutaneous
1 x 0.5 mL syringe, 10 x 0.5 mL syringe
(S4) Prescription Only Medicine
For the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine. The vaccine is indicated for use only in persons aged 5 years and over. For full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.
Visual Identification: A clear to slightly opaque liquid with some sediment that resuspends upon shaking; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 15 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-01-09
Afluria® Quad 1 AFLURIA® 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. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING AFLURIA® QUAD? Afluria® Quad contains the active ingredient influenza virus haemagglutinin. Afluria® Quad is a vaccine that helps prevent influenza, often called “the flu’. Afluria® Quad is indicated for use only in persons aged 5 years and over. For more information, see Section 1. Why am I using Afluria® Quad? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE BEING GIVEN AFLURIA® QUAD? Tell your doctor, nurse or pharmacist if you or your child have ever had an allergic reaction to Afluria® Quad or any of the ingredients listed at the end of the CMI or any other influenza vaccine. TALK TO YOUR DOCTOR IF YOU OR YOUR CHILD HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before being given Afluria® Quad? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Afluria® 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 AFLURIA® QUAD GIVEN? • Afluria® Quad is given as an injection, usually into the muscle or under the skin of your upper arm by a doctor, nurse or pharmacist. • Afluria® Quad is given once every year for adults and children 5 years and over in one injection of 0.5 mL. • For children 5 to under 9 years old who are receiving influenza vaccine for the first time, it is recommended that a follow- up (booster) dose of Afluria® Quad is given at least 4 weeks after the first dose. More instructions can be found in Section 4. How is Afluria® Quad given? in the full CMI. 5. WHAT SHOULD I KNOW ABOUT Belgenin tamamını okuyun
Seqirus Afluria ® Quad AUST R 262428 & AUST R 294907 Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION AFLURIA ® QUAD (INFLUENZA VIRUS HAEMAGGLUTININ) WARNING: AFLURIA ® QUAD VACCINE IS INDICATED FOR USE ONLY IN PERSONS AGED 5 YEARS AND OVER. IT MUST NOT BE USED IN PERSONS UNDER 5 YEARS (SEE CONTRAINDICATIONS). FOR SEASON 2022 1 NAME OF THE MEDICINE AFLURIA ® QUAD Inactivated quadrivalent influenza vaccine (split virion) suspension for injection; containing Influenza virus haemagglutinin as active ingredient. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION This is a purified, inactivated, split virion (split virus) vaccine. Each 0.5 mL dose contains antigens for the 2022 influenza season representative of the following types: - 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 Afluria ® Quad is manufactured in eggs and trace amounts of sodium taurodeoxycholate (TDOC) (≤5 micrograms), ovalbumin (<1 microgram/0.5mL dose), sucrose, neomycin sulfate, polymyxin B sulfate, propiolactone and hydrocortisone may be present. For the full list of excipients, see SECTION 6.1 - LIST OF EXCIPIENTS . The type and amount of viral antigens in Afluria ® Quad vaccine conform to the requirements of the Australian Influenza Vaccine Committee for the winter of 2022. The strains chosen for vaccine manufacture are endorsed by the Australian Influenza Vaccine Committee as being antigenically equivalent to the reference virus. Seqirus Afluria ® Quad AUST R 262428 & AUST R 294907 Page 2 of 17 The vaccine is prepared from virus grown in the allantoic cavity of embryonated eggs, purified by zonal centrifugation, inactivated by propiolactone and disrupted by TDOC. Afluria ® Quad vaccine conforms in saf Belgenin tamamını okuyun