Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
COVID-19 MRNA VACCINE
PFIZER PHARMACEUTICALS ISRAEL LTD
J07BX03
CONCENTRATE FOR DISPERSION FOR INJECTION
COVID-19 MRNA VACCINE 0.5 MG/ML
I.M
Required
PFIZER INC, USA
COVID-19 VACCINES
Comirnaty is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.
2021-09-13
Comirnaty PIL CC 150223 P fleet 2022-0079021, 2022-0079929, 2022-0082402, 2022-0075548, 2022-0080972 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only COMIRNATY ® CONCENTRATE FOR DISPERSION FOR INTRAMUSCULAR INJECTION ACTIVE INGREDIENT: COVID-19 MRNA VACCINE Inactive ingredients and allergens: See section 2 under “Important information about some of this medicine’s ingredients” and section 6 “Further information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Comirnaty is an active vaccine intended to prevent COVID-19 caused by SARS-CoV-2 coronavirus, in adults and adolescents from 12 years of age and older. THERAPEUTIC GROUP: vaccines, other viral vaccines. The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19. The vaccine does not contain the virus so it cannot give you COVID-19 (corona). 2. BEFORE USING THIS MEDICINE DO NOT USE COMIRNATY IF: • You or your child is sensitive (allergic) to the active ingredients or to any of the other ingredients in this medicine (listed in section 6). SPECIAL WARNINGS REGARDING USE OF COMIRNATY BEFORE RECEIVING THE VACCINE, TELL YOUR DOCTOR OR NURSE IF: • you have ever had a severe allergic reaction or breathing problems after receiving any other vaccine or after receiving Comirnaty in the past. • you are feeling nervous about the vaccination process or have ever fainted following any needle injection. • you have a severe illness or infection with high fever. However, you can have your vaccination Prečítajte si celý dokument
Comirnaty LPD CC 281123 2023-0086009 1 COMIRNATY™ 1. NAME OF THE MEDICINAL PRODUCT Comirnaty COVID-19 mRNA Vaccine (nucleoside modified) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION This is a multidose vial with a purple cap and must be diluted before use. One vial (0.45 mL) contains 6 doses of 0.3 mL after dilution, see sections 4.2 and 6.6. One dose (0.3 mL) contains 30 micrograms of tozinameran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles). Tozinameran is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free _in vitro_ transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for dispersion for injection (sterile concentrate). The vaccine is a white to off-white frozen dispersion (pH: 6.9 - 7.9). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Comirnaty is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 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 12 years of age and older _ Comirnaty is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose (see sections 4.4 and 5.1). _Interchangeability _ The interchangeability of Comirnaty with other COVID-19 vaccines from other manufacturers to complete the vaccination course has not been established. Individuals who have received 1 dose of Comirnaty should receive a second dose of Comirnaty to complete the vaccination course. Doses of Comirnaty (supplied in a vial with a purple cap) and Comirnaty TRIS 30 (supplied in a vial with a grey cap) are considered interchangeable. Comirnaty LPD CC 281123 2023-0086009 2 _Paediatric population _ There is a paediatric formulation available for individuals 5 to 11 years of age (i.e. 5 to Prečítajte si celý dokument