Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
rAd26.COV2-S
JOHNSON & JOHNSON SDN BHD
rAd26.COV2-S
10 Vials
JANSSEN PHARMACEUTICA N.V.
DISCLAIMER: THIS PRODUCT IS APPROVED UNDER MALAYSIA CONDITIONAL REGISTRATION FOR PHARMACEUTICAL PRODUCTS DURING DISASTER GUIDELINE. THE ADMINISTRATION OF THE PRODUCT IS PURELY BASED ON INDIVIDUAL’S PREFERENCE. JANSSEN COVID-19 VACCINE SUSPENSION FOR INJECTION Ad26.COV2-S (recombinant) (not less than 8.92 log 10 infectious units (Inf.U)/0.5mL) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Janssen COVID-19 Vaccine is used for 2. How Janssen COVID-19 Vaccine works 3. Before you use Janssen COVID-19 Vaccine 4. How to use Janssen COVID-19 Vaccine 5. While you are using it 6. Side effects 7. Storage and disposal of Janssen COVID-19 Vaccine 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT JANSSEN COVID-19 VACCINE IS USED FOR Janssen COVID-19 Vaccine is a vaccine used for preventing COVID-19 caused by the SARS-CoV-2 virus. Janssen COVID-19 Vaccine is given to adults aged 18 years and older. HOW JANSSEN COVID-19 VACCINE WORKS The vaccine causes the immune system (the body’s natural defences) to produce antibodies and specialised white blood cells that work against the virus, so giving protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19. BEFORE YOU USE JANSSEN COVID-19 VACCINE - _When you must not use it _ Do not have the vaccine if: • You are allergic to the active substance or any of the other ingredients of this vaccine. • You have 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. • You have a previous diagnosis of capillary leak syndrome, (a condition causing fluid leakage from small blood vessels). - _Before you start to use it _ Talk to your doctor, pharmacist or nurse before you are given Janssen COVID-19 Vaccine if: • you have ever had a severe allergic reaction after injection of any other vaccine, • you have ever fainted following any needle injecti Lestu allt skjalið
1 DISCLAIMER: THIS PRODUCT IS APPROVED UNDER MALAYSIA CONDITIONAL REGISTRATION FOR PHARMACEUTICAL PRODUCTS DURING DISASTER GUIDELINE. THE ADMINISTRATION OF THE PRODUCT IS PURELY BASED ON INDIVIDUAL’S PREFERENCE. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are required to report all suspected adverse reactions. This product information will be updated on a regular basis as further data and safety reports become available. 1. NAME OF THE MEDICINAL PRODUCT Janssen COVID-19 Vaccine Suspension for Injection (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), 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). 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 Janssen COVID-19 Vaccine 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Individuals 18 years of age and older _ Primary vaccination COMMENTED [TZW[1]: Align with EU PI vDec2021 2 Janssen COVID-19 Vaccine is administered as a single-dose of 0.5 mL by intramuscular injection only. Homologous booster dose A booster dose (second dose) of 0.5 mL of Janssen COVID-19 Vaccine may be administered intramuscularly at least 2 months after the primary vaccination in individuals 18 y Lestu allt skjalið