Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
CX-024414 MRNA
MEDISON PHARMA LTD
J07BX03
DISPERSION FOR INJECTION
CX-024414 MRNA 1.26 MG/VIAL
I.M
Required
MODERNA BIOTECH SPAIN, S.L.., SPAIN
COVID-19 VACCINES
Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
2021-12-30
Page 1 of 7 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only SPIKEVAX 0.2 MG/ML DISPERSION FOR INJECTION ACTIVE INGREDIENT AND ITS QUANTITY: elasomeran 1.26 mg/vial mRNA Vaccine encoding the SARS-CoV-2 spike protein Inactive ingredients and allergens - see section 6 "Additional information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START 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 to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? Spikevax is an active vaccine used to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The active substance in Spikevax is mRNA encoding the SARS-CoV-2 spike protein. The mRNA is embedded in SM-102 lipid nanoparticles. As Spikevax does not contain the virus, it cannot give you COVID-19. THERAPEUTIC GROUP: Vaccine, other viral vaccines. HOW THE VACCINE WORKS Spikevax stimulates the body ’ s natural defences (immune system). The vaccine works by causing the body to produce protection (antibodies) against the virus that causes COVID-19. Spikevax uses a substance called messenger ribonucleic acid (mRNA) to carry instructions that cells in the body can use to make the spike protein that is also on the virus. The cells then make antibodies against the spike protein to help fight off the virus. This will help to protect you against COVID-19. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine (see section 6 "Additional information"). SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE RECEIVING THE VACCINE, TELL YOUR DOCTOR, PHARMACIST OR THE NURSE IF: • you have previously had Pročitajte cijeli dokument
1 1. NAME OF THE MEDICINAL PRODUCT Spikevax 0.2 mg/mL dispersion for injection elasomeran 1.26 mg/vial COVID-19 mRNA Vaccine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TABLE 1. QUALITATIVE AND QUANTITATIVE COMPOSITION BY STRENGTH AND TYPE OF CONTAINER STRENGTH CONTAINER DOSE(S) COMPOSITION PER DOSE SPIKEVAX 0.2 MG/ML DISPERSION FOR INJECTION Multidose vial (red flip-off cap) Maximum 10 doses of 0.5 mL each One dose (0.5 mL) contains 100 micrograms of elasomeran, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in lipid nanoparticles). Maximum 20 doses of 0.25 mL each One dose (0.25 mL) contains 50 micrograms of elasomeran, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in lipid nanoparticles). Elasomeran 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 (original). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dispersion for injection White to off white dispersion (pH: 7.0 – 8.0). 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Spikevax 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 Refer to Table 2 for dosing across Spikevax vaccination type. 2 TABLE 2. SPIKEVAX POSOLOGY FOR PRIMARY SERIES, A THIRD DOSE IN SEVERELY IMMUNOCOMPROMISED AND BOOSTER DOSES _ _ _ _ STRENGTH VACCINATION TYPE AGE(S) DOSE RECOMMENDATIONS SPIKEVAX 0.2 MG/ML DISPERSION FOR INJECTION Primary series Individuals 18 years of age and older 2 (two) doses (0.5 mL each, containing 100 micrograms mRNA) It is recommended to administer the second dose 28 days after the first dose. A dosing window of 3 to 6 weeks for administration of the second dose can be allowed in special cases (see sections 4.4 and 5.1). There are limited data available on the interc Pročitajte cijeli dokument