Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AZD1222
ASTRAZENECA SDN. BHD.
AZD1222
10 Vials
SK bioscience Co., Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 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 VAXZEVRIA _ _ Solution for Injection COVID-19 Vaccine (ChAdOx1-S [recombinant]), 5×10 10 viral particles 1 WHAT IS IN THIS LEAFLET 1. What Vaxzevria is used for 2. How Vaxzevria works 3. Before you use Vaxzevria 4. How to use Vaxzevria 5. While you are using it 6. Side effects 7. Storage & Disposal of Vaxzevria 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT VAXZEVRIA IS USED FOR Vaxzevria is used for preventing COVID-19 caused by SARS-CoV- 2 virus. Vaxzevria is given to adults aged 18 years and older. HOW VAXZEVRIA 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 VAXZEVRIA _ _ _When you must not use it _ THE VACCINE MUST NOT BE GIVEN: - If you are allergic to the active substance or any of the other ingredients of this vaccine (see _Ingredient_ subsection). - If you have had a major blood clot occurring at the same time as having low levels of platelets (thrombocytopenia) after receiving any COVID-19 vaccine. _Children and adolescents _ Vaxzevria is not recommended for children aged below 18 years. Currently there is not enough information available on the use of Vaxzevria in children and adolescents younger than 18 years of age. _Before you start to use it _ Tell your doctor, pharmacist or nurse before vaccination: • If you have ever had a severe allergic reaction after any other vaccine injection or after you were given Vaxzevria in the past; • If you have ever fainted following any needle injection; • If you have a severe infection with a high body temperatur Baca dokumen lengkap
ASTRAZENECA SDN BHD Nucleus Tower, Level 12 No. 10, Jalan PJU 7/6, Mutiara Damansara 47800 Petaling Jaya, Selangor, Malaysia Company Regn No. 69730-X 17 DECEMBER 2021 DEAR HEALTHCARE PROFESSIONAL, CONDITIONAL REGISTRATION OF VAXZEVRIA SOLUTION FOR INJECTION WITH EXEMPTIONS FROM MALAYSIA SPECIFIC LABELLING REQUIREMENTS With regards to the matter above, AstraZeneca would like to inform that the approval in Malaysia is supported by common pack product label and carton to facilitate supply during pandemic period. In order to make the artwork acceptable to multiple countries around the world during the pandemic the artwork is exempted from a number of country specific labelling requirements. There will not be country-specific packs for Malaysia until the post pandemic period which has not been determined yet. 2. Enclosed are the additional Malaysian local labelling information for your reference which will not be included in the artwork during the pandemic period. IMMEDIATE LABEL PRODUCT INFORMATION DETAILS Product Name Vaxzevria Solution for Injection Strength of active substance 1 x 10^11 vp/ml Name and content of alcohol Ethanol 2 mg per 0.5 ml dose OUTER CARTON PRODUCT INFORMATION DETAILS Name and content of alcohol This medicinal product contains 2 mg of alcohol (ethanol) per 0.5 ml dose. Disposal Vaxzevria contains genetically modified organisms (GMOs). Any unused vaccine or waste material should be disposed of in accordance with local requirements. Spills should be disinfected with an appropriate antiviral disinfectant. Keep out of the sight and reach of children Jauhi dari pandangan dan jangkauan kanak-kanak Strength of active substance 1 x 10^11 vp/ml Batch Releaser SK Bioscience Co Limited (No.97), 150, Saneopdanji-gil, Pungsan-eup, Andong-si, Gyeongsangbuk-do, Republic of Korea Local Registration Number (MAL Number) MAL21116002ASZ Product Registration Holder AstraZeneca Sdn Bhd (69730-X) ASTRAZENECA SDN BHD Nucleus Tower, Level 12 No. 10, Jalan PJU 7/6, Mutiara Damansara 47800 Petaling Jaya, Selangor, Malay Baca dokumen lengkap