Comirnaty

Riik: Euroopa Liit

keel: portugali

Allikas: EMA (European Medicines Agency)

Osta kohe

Infovoldik Infovoldik (PIL)
15-12-2023
Toote omadused Toote omadused (SPC)
15-12-2023
Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
28-09-2023

Toimeaine:

Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2

Saadav alates:

BioNTech Manufacturing GmbH

ATC kood:

J07BN01

INN (Rahvusvaheline Nimetus):

tozinameran, riltozinameran and tozinameran, famtozinameran and tozinameran, COVID-19 mRNA Vaccine (nucleoside modified)

Terapeutiline rühm:

Vacinas

Terapeutiline ala:

COVID-19 virus infection

Näidustused:

Comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.  Comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.  Comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.  Comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years.  Comirnaty Original/Omicron BA. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19. Comirnaty Original/Omicron BA. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. Comirnaty Original/Omicron BA. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. Comirnaty Original/Omicron BA. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.  Comirnaty Original/Omicron BA. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years.  Comirnaty Omicron XBB. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. Comirnaty Omicron XBB. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. Comirnaty Omicron XBB. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. Comirnaty Omicron XBB. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years. O uso desta vacina deve ser de acordo com as recomendações oficiais.

Toote kokkuvõte:

Revision: 45

Volitamisolek:

Autorizado

Loa andmise kuupäev:

2020-12-21

Toote omadused

                                ANEXO I
RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO
1
Este medicamento está sujeito a monitorização adicional. Isto irá
permitir a rápida identificação de
nova informação de segurança. Pede-se aos profissionais de saúde
que notifiquem quaisquer suspeitas
de reações adversas. Para saber como notificar reações adversas,
ver secção 4.8.
1.
NOME DO MEDICAMENTO
Comirnaty 30 microgramas/dose concentrado para dispersão injetável
Vacina de mRNA contra a COVID-19 (com nucleósido modificado)
2.
COMPOSIÇÃO QUALITATIVA E QUANTITATIVA
Frasco para injetáveis multidose com uma tampa roxa que tem de ser
diluído antes da utilização.
Um frasco para injetáveis (0,45 ml) contém 6 doses de 0,3 ml após a
diluição, ver secções 4.2 e 6.6.
Uma dose (0,3 ml) contém 30 microgramas de tozinamerano, uma vacina
de mRNA contra a COVID-
19 (incorporados em nanopartículas lipídicas).
Tozinamerano é um RNA mensageiro (mRNA) de cadeia simples com
estrutura 5-cap, produzido
usando transcrição
_in vitro _
sem células a partir dos moldes de DNA correspondentes, codificando a
proteína S (
_Spike_
) do vírus SARS-CoV-2.
Lista completa de excipientes, ver secção 6.1.
3.
FORMA FARMACÊUTICA
Concentrado para dispersão injetável (concentrado estéril).
A vacina é uma dispersão congelada de cor branca a esbranquiçada
(pH: 6,9 – 7,9).
4.
INFORMAÇÕES CLÍNICAS
4.1
INDICAÇÕES TERAPÊUTICAS
Comirnaty 30 microgramas/dose concentrado para dispersão injetável
é indicado para a imunização
ativa para prevenir a COVID-19 causada pelo SARS-CoV-2 em indivíduos
com idade igual ou
superior a 12 anos.
A utilização desta vacina deve seguir as recomendações oficiais.
4.2
POSOLOGIA E MODO DE ADMINISTRAÇÃO
Posologia
_ _
_Indivíduos com idade igual ou superior a 12 anos _
Comirnaty é administrado por via intramuscular após a diluição
como uma dose única de 0,3 ml para
indivíduos com idade igual ou superior a 12 anos, independentemente
do estado de vacinação anterior
contra a COVID-19 (ver secções 4.4 
                                
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