Kraj: Nowa Zelandia
Język: angielski
Źródło: Medsafe (Medicines Safety Authority)
Ad26.COV2.S 100 GVP/mL (GVP = Giga Viral Particles; equivalent to not less than to 8.92 log10 infectious units per dose)
Janssen-Cilag (New Zealand) Ltd
Suspension for injection
Active: Ad26.COV2.S 100 GVP/mL (GVP = Giga Viral Particles; equivalent to not less than to 8.92 log10 infectious units per dose) Excipient: Citric acid monohydrate Ethanol Hydrochloric acid Hydroxypropyl-beta-cyclodextrin Polysorbate 80 Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water for injection
Prescription
COVID-19 Vaccine Janssen has provisional consent for the indication below: Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations.
Package - Contents - Shelf Life: Vial, glass, multi-dose, 10 x 2.5mL 2R Type 1 glass vial closed with latex-free chlorobutyl rubber stopper - 50 dose units - 24 months from date of manufacture stored below -20°C (Deep freeze) protect from light 11 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 hours opened stored at or below 25°C protect from light
2020-12-08
COVID-19 V ACCINE JANSSEN (230309) NZCMIv8 1 COVID-19 VACCINE JANSSEN NEW ZEALAND CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this vaccine, speak to your doctor or pharmacist. 1. WHY AM I RECEIVING COVID-19 VACCINE JANSSEN? COVID-19 Vaccine Janssen contains the active ingredient Ad26.COV2.S. COVID-19 Vaccine Janssen is a vaccine used for preventing COVID-19 caused by the SARS-CoV-2 virus. COVID-19 Vaccine Janssen is given to adults aged 18 years and older. For more information, see Section 1. Why am I receiving COVID-19 Vaccine Janssen? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I RECEIVE COVID-19 VACCINE JANSSEN? Do not receive if: - you have ever had an allergic reaction to any of the ingredients listed at the end of the full CMI. - you have ever had a diagnosis of capillary leak syndrome, a very rare, serious condition where fluid (plasma) leaks out of the small blood vessels into the body tissues. - you have had a blood clot occurring at the same time as having low levels of blood platelets (thrombosis with thrombocytopenia syndrome, TTS) after receiving any COVID-19 vaccine. 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 I receive COVID-19 Vaccine Janssen? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with COVID-19 Vaccine Janssen and affect how it works. For more information, see Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I RECEIVE COVID-19 VACCINE JANSSEN? Your doctor, pharmacist or nurse will give the vaccine as an injection into the muscle (usually in the upper arm). You may receive COVID-19 Vaccine Janssen as a single dose as a primary vaccination. You may also receive COVID-19 Vaccine Janssen as a booster dose after primary vaccination with COVID-19 Vaccine Janssen or after a primary v Przeczytaj cały dokument
12.220614 Page 1 of 26 COVID-19 VACCINE JANSSEN (230309) DSv10 COVID-19 VACCINE JANSSEN ® AD26.COV2.S DATA SHEET 1. PRODUCT NAME COVID-19 Vaccine Janssen 5×10 10 virus particles (VP) in 0.5 mL suspension for injection COVID-19 vaccine (Ad26.COV2.S [recombinant]) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION This is a multi-dose vial which contains 5 doses of 0.5 mL. One dose (0.5 mL) contains: Adenovirus type 26 encoding the SARS-CoV-2 spike (S) glycoprotein* (Ad26.COV2-S), 5×10 10 virus particles (VP) (equivalent to not less than 8.92 log _10_ infectious units (Inf.U)). * Produced in the PER.C6 ® TetR Cell Line and by recombinant DNA technology. The product contains genetically modified organisms (GMOs) under GMO regulations in other jurisdictions. Please note that under the New Zealand Hazardous Substances and New Organisms (HSNO) Act, this product is not considered a GMO. Excipients with known effect Each dose (0.5 mL) contains approximately 2 mg of ethanol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection (injection). Colourless to slightly yellow, clear to very opalescent suspension (pH 6-6.4). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COVID-19 Vaccine Janssen has provisional consent (see section 5.1) for the indication below: Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations. 12.220614 Page 2 of 26 COVID-19 VACCINE JANSSEN (230309) DSv10 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE INDIVIDUALS 18 YEARS OF AGE AND OLDER _PRIMARY VACCINATION _ COVID-19 Vaccine Janssen is administered as a single dose of 0.5 mL by intramuscular injection only. _BOOSTER DOSE _ A booster dose (second dose) of 0.5 mL of COVID-19 Vaccine Janssen may be administered intramuscularly at least 2 months after the primary vaccination in individuals 18 years of age and older. Higher immune responses are observed with an interval up to 6 months between Przeczytaj cały dokument