Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
rAd5-nCoV
Solution Biologics Sdn. Bhd.
rAd5-nCoV
2ml glass vial (0.5mil/vial) in one small box Vials (Quantity) Vials
CanSino Biologics Inc
_Consumer Medication Information Leaflet (RiMUP)_ _ _ CONFIDENTIAL Page 1 of 2 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. CONVIDECIA Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Solution for Injection WHAT IS IN THIS LEAFLET 1. What CONVIDECIA is used for 2. How CONVIDECIA works 3. Before you use CONVIDECIA 4. How to use CONVIDECIA 5. While you are using it 6. Side effects 7. Storage and Disposal of CONVIDECIA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT CONVIDECIA IS USED FOR CONVIDECIA is indicated for active immunization 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 HOW CONVIDECIA WORKS CONVIDECIA stimulates the body’s natural defences (immune system). It causes the body to produce its own protection (antibodies) against the virus. This will help to protect you against COVID-19 in the future. None of the ingredients in this vaccine can cause COVID-19. BEFORE YOU USE CONVIDECIA _When you must not use it _ DO NOT TAKE CONVIDECIA if you have ever had an allergic reaction to any component of this vaccine or similar vaccines, (see _ingredient_ subsection) of this vaccine or similar vaccines. People who have experienced severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, Those who have been injected with immune globulin should vaccinate at an interval of more than 1 month to avoid decreasing the immune effect. _ _ _Taking other medicines _ Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines HOW TO USE CONVIDECIA _How much to use & when to use _ CONVIDECIA should be injected into the deltoid muscle of the upper arm as a single Прочитать полный документ
CanSino Biologics Inc., 185 South Avenue, TEDA West District, Tianjin, China 300462 Page 1 of 11 V1.0 First Approval Date: MM DD YYYY Revision date: MM DD YYYY PACKAGE INSERT CONVIDECIA (TRADE MARK) RECOMBINANT NOVEL CORONAVIRUS VACCINE (ADENOVIRUS TYPE 5 VECTOR) SOLUTION FOR INJECTION 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 asked to report any suspected new or _ _serious adverse events. This product information will be updated on a regular basis as further _ _data and safety reports become available _ 1. DRUG NAME Proprietary Name: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Solution For Injection Trade Name: Convidecia or CONVIDECIA 2. DESCRIPTION The final product is sterile liquid injection in single dose 2 ml glass vials (0.5 ml liquid per dose). The vaccine is colorless or slightly white liquid injection. ACTIVE INGREDIENT: Each 0.5mL contains ≥ 4×10 10 viral particles of replication-defective recombinant human type 5 Adenovirus expressing S protein of SARS-CoV-2. CanSino Biologics Inc., 185 South Avenue, TEDA West District, Tianjin, China 300462 Page 2 of 11 EXCIPIENTS: Mannitol, sucrose, sodium chloride, magnesium chloride, polysorbate 80, glycerin, and N-(2-Hydroxyethyl) piperazine-N’-(2-ethanesulfonic acid) (HEPES) and Water-For- Injection as solvent. 3. INDICATIONS AND USAGE Convidecia is indicated for active immunization 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. RECOMMENDED DOSAGE Individuals 18 years of age and older: Single dose. Each dose contains 0.5 mL liquid injection, supplied in a single-dose glass vial. Pediatric Populatio Прочитать полный документ