Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Inactivated SARS-CoV-2 virus (CZ02 strain) (Vero cell)
PHARMANIAGA LIFESCIENCE SDN. BHD.
Inactivated SARS-CoV-2 virus (CZ02 strain) (Vero cell)
40 Vials; 40 Vials
Sinovac Life Sciences 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. CORONAVAC SUSPENSION FOR INJECTION COVID-19 VACCINE (VERO CELL), INACTIVATED COVID-19 Vaccine (Vero Cell), Inactivated (600 SU equivalent to 3µg) CONFIDENTIAL Page No. 1 of 4 WHAT IS IN THIS LEAFLET 1. What CoronaVac is used for 2. How CoronaVac works 3. Before you use CoronaVac 4. How to use CoronaVac 5. While you are using it 6. Side Effects 7. Storage and Disposal of CoronaVac 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT CORONAVAC IS USED FOR CoronaVac is a vaccine used to prevent COVID-19 caused by coronavirus (SARS-CoV-2). CoronaVac is given to adults and children from 5 years of age and older. A booster dose of CoronaVac may be administered at least 3-6 months after the second dose in individuals 18 years of age and older. HOW CORONAVAC WORKS The vaccine stimulates the immune system (the body’s natural defences) to produce its own antibodies and blood cells that work against the virus. This will help to increase your protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19. BEFORE YOU USE CORONAVAC - _When you must not use it _ DO NOT TAKE CORONAVAC : - if you are allergic to CoronaVac or any of the other ingredients of CoronaVac (see section _Product Description_ ). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. Contact your doctor or go to the nearest hospital emergency immediately if you have an allergic reaction - if you have a history of allergic reactions to other vaccines - if you have any severe neurological conditions such as spinal cord inflammation and Guillain- Barré syndrome - if you have uncontrolled severe chronic illnesses - if you have an infection with high feve Baca dokumen lengkap
CORONAVAC SUSPENSION FOR INJECTION COVID-19 VACCINE (VERO CELL), INACTIVATED CONTROLLED MEDICINE / UBAT TERKAWAL DISCLAIMER: THIS PRODUCT IS APPROVED UNDER MALAYSIAN 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 asked to report any suspected new or serious adverse reactions. This product information will be updated on a regular basis as further data and safety reports become available. The information stated on inner and outer carton labels is based on the global label. For Malaysia specific information, please refer this package insert. COMPOSITION Each dose (0.5 mL) contains 600 SU (equivalent to 3µg) of inactivated SARS-CoV-2 antigen. Excipient: Aluminium hydroxide, disodium hydrogen phosphate, monosodium dihydrogen phosphate, sodium chloride and water for injection. There is no preservative in this product. DESCRIPTION CoronaVac is a milky-white (opalescent) suspension. Stratified precipitate may form which can be dispersed by shaking. CoronaVac is available in the following presentations: • Single-dose (1 dose) vial of 0.5 mL • Multi-dose (2 doses) vial of 1.0 mL INDICATION CoronaVac is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 5 years of age and older. The use of this vaccine should be in accordance with official recommendations. RECOMMENDED DOSAGE _Individuals 18 years of age and older _ Two doses should be administered for primary immunization. The second dose is preferably given 14 - 28 days after the first dose. 0.5 mL per dose. A booster dose (0.5ml) may be administered at least 3-6 months after the second dose when the potential benefits outweigh any potential risks. The decision when and for whom to implement a booster dose of the vaccine should be made based on available vaccine Baca dokumen lengkap