Země: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Influenza virus A/Darwin/9/2021 (H3N2)-like strain 15ug (A/Darwin/9/2021 SAN-010 ); Influenza virus A/Sydney/5/2021 (H1N1) pdm09-like strain 15ug (A/Sydney/5/2021, SAN-013); Influenza virus B/Austria/1359417/2021-like strain 15ug (B/Michigan/01/2021 wild type ); Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013 wild type )
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15 µg (A/Michigan/45/2015, X-275)
60 mcg
Suspension for injection
Active: Influenza virus A/Darwin/9/2021 (H3N2)-like strain 15ug (A/Darwin/9/2021 SAN-010 ) Influenza virus A/Sydney/5/2021 (H1N1) pdm09-like strain 15ug (A/Sydney/5/2021, SAN-013) Influenza virus B/Austria/1359417/2021-like strain 15ug (B/Michigan/01/2021 wild type ) Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013 wild type ) Excipient: Octoxinol 9 Phosphate Buffered Saline
Prescription
Sanofi Pasteur Inc
FluQuadri is indicated for active immunisation of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluQuadri is indicated for use in adults and children 6 months and older.
Package - Contents - Shelf Life: Syringe, 0.5 mL in type I USP glass cylinder with 5 needles - 5 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, 0.5 mL in type I USP glass cylinder - 5 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, 0.5 mL in type I USP glass cylinder - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
2013-08-13
FluQuadri™ 1 FLUQUADRI™ 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 FLUQUADRI? FluQuadri is a vaccine. This vaccine helps to protect you against influenza (flu). FluQuadri is used to prevent flu in persons of 6 months of age and older. For more information, see Section 1. Why am I using FluQuadri? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE BEING GIVEN FLUQUADRI? Do not use if you have ever had an allergic reaction to FluQuadri or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU 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 FluQuadri? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with FluQuadri and affect how it works. Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other vaccines or medicines, including medicines obtained without a prescription. For more information, see Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS FLUQUADRI GIVEN? FluQuadri is given by your doctor, nurse or pharmacist. More instructions can be found in Section 4. How is FluQuadri given? in the full CMI. 5. WHAT SHOULD I KNOW ABOUT BEING GIVEN FLUQUADRI? THINGS YOU SHOULD DO Tell your doctor, nurse or pharmacist after you or your child receive the vaccine • have signs of allergic reactions that may include difficulty breathing, shortness of breath, swelling of the face, lips, throat or tongue, cold, clammy skin, palpitations, dizziness, weakness, fainting, rash or itching. LOOKING AFTER YOUR MEDICINE FluQuadri is usually stored in the surgery or clinic, or at the pharmacy. However, if you need to store FluQuadri: • keep in the fridge between 2-8°C. Do not freeze. For more information, Přečtěte si celý dokument
fluquadri-ccdsv2-dsv8-02dec22 1 NEW ZEALAND DATA SHEET – FLUQUADRI™ INFLUENZA VIRUS HAEMAGGLUTININ 1 NAME OF THE MEDICINE FluQuadri™ Inactivated Quadrivalent Influenza Vaccine, Split Virion (Influenza Virus Haemagglutinin) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FluQuadri for intramuscular injection is an inactivated influenza virus vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octoxinol-9 (Triton ® X-100), producing a “split virus”. The split virus is further purified and then suspended in sodium phosphate- buffered isotonic sodium chloride solution. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. It is formulated to contain the following four influenza strains recommended for the 2023 influenza season: ACTIVE SUBSTANCE QUANTITY (PER 0.5ML DOSE) A/Sydney/5/2021 (H1N1)pdm09 - like strain (A/Sydney/5/2021, SAN-013) 15 micrograms HA** A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/9/2021, SAN-010) 15 micrograms HA** B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type) 15 micrograms HA** ** haemagglutinin FluQuadri contains 60 micrograms (µg) haemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 µg HA of each of the four strains. The type and amount of viral antigens contained in FluQuadri conform to the annual requirements of the Australian Influenza Vaccine Committee (AIVC) and the World Health Organization (WHO) recommendations for the season. Neither antibiotics nor preservative are used during manufacture. FluQuadri is presented in prefilled syringes that are not made with natural rubber latex Přečtěte si celý dokument