Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
Ad26.COV2.S, Quantity: 50000000000 vp
Janssen-Cilag Pty Ltd
Injection, suspension
Excipient Ingredients: sodium chloride; polysorbate 80; sodium hydroxide; hydroxypropylbetadex; citric acid monohydrate; sodium citrate dihydrate; ethanol absolute; hydrochloric acid; water for injections
Intramuscular
10
(S4) Prescription Only Medicine
COVID-19 Vaccine Janssen has provisional approval for the indication:,COVID-19 Vaccine Janssen is indicated for 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. The decision has been made on the basis of short term efficacy and safety data. Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
Visual Identification: Colourless to slightly yellow, clear to very opalescent suspension; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 11 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2021-06-25
COVID-19 Vaccine Janssen 1 COVID-19 VACCINE JANSSEN This vaccine has PROVISIONAL APPROVAL in Australia for preventing COVID-19 caused by the SARS-CoV-2 virus in adults aged 18 years and older. This approval has been granted on the basis of short term efficacy and safety data. Evidence of longer term efficacy and safety from ongoing clinical trials and vaccination in the community continues to be gathered and assessed. 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. This vaccine is new. Please report side effects. See the full CMI for further details. 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. 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. COVID-19 Vaccine Janssen should not be given to children under 18 years. 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, phar Olvassa el a teljes dokumentumot
This vaccine is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. 11.220211 Page 1 of 17 COVID-19 JANSSEN (220817) API ▼ COVID-19 VACCINE JANSSEN ® AD26.COV2.S AUSTRALIAN PRODUCT INFORMATION 1. NAME OF THE MEDICINE COVID-19 Vaccine Janssen 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 glycoprotein* (Ad26.COV2-S; SARS-CoV-2 spike (S) protein sequence from Wuhan/WIV04/2019; Genbank MN908947), 5×10 10 virus particles (VP) (equivalent to not less than 8.92 log _10_ infectious units (Inf.U)). *The vaccine was manufactured using material sourced from a human embryo (Human Embryonic Retinal cells: PER.C6 cells). The product contains genetically modified organisms (GMOs). 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 APPROVAL for the indication: COVID-19 Vaccine Janssen is indicated for 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. 11.220211 Page 2 of 17 COVID-19 JANSSEN (220817) API The decision has been made on the basis of short term efficacy and safety data. Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE _INDIVIDUALS 18 YEARS OF AGE AND OLDER _ COVID-19 Olvassa el a teljes dokumentumot