Comirnaty

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Tozinameran 0.1 mg/mL equivalent to 30 µg/0.3mL dose;  ;  ;  ;  

Saadav alates:

Pfizer New Zealand Limited

Annus:

0.1 mg/mL

Ravimvorm:

Suspension for injection

Koostis:

Active: Tozinameran 0.1 mg/mL equivalent to 30 µg/0.3mL dose         Excipient: 1,2-Distearoyl-sn-glycero-3-phosphocholine ALC-0159 ALC-0315 Cholesterol Sucrose Trometamol Trometamol hydrochloride Water for injection

Retsepti tüüp:

Prescription

Näidustused:

Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.

Toote kokkuvõte:

Package - Contents - Shelf Life: Vial, glass, multi-dose, (2.25 mL fill), closed with rubber stopper, aluminium overseal and grey flip-off plastic cap - 10 dose units - 24 months from date of manufacture stored in the freezer at -90°C to -60°C protect from light 24 hours unopened stored at or below 30°C. Applies to thawed vials. Do not refreeze. 10 weeks unopened stored at 2° to 8°C (Refrigerate, do not freeze). Applies to thawed vials within the 24 month shelf-life. Do not refreeze. 12 hours opened stored at or below 30°C - Vial, glass, multi-dose, (2.25 mL fill), closed with rubber stopper, aluminium overseal and grey flip-off plastic cap - 195 dose units - 24 months from date of manufacture stored in the freezer at -90°C to -60°C protect from light 24 hours unopened stored at or below 30°C. Applies to thawed vials. Do not refreeze. 10 weeks unopened stored at 2° to 8°C (Refrigerate, do not freeze). Applies to thawed vials within the 24 month shelf-life. Do not refreeze. 12 hours opened stored at or below 30°C

Loa andmise kuupäev:

2021-11-12

Infovoldik

COMIRNATY®
1
COMIRNATY® COVID-19 VACCINE AGE 12 YEARS AND
OLDER
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about receiving this vaccine, speak to your doctor or
pharmacist.
1.
WHY AM I BEING GIVEN COMIRNATY?
COMIRNATY is a vaccine given to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) in adults and adolescents from 12 years of
age and older. COMIRNATY contains the active ingredient
tozinameran. For more information, see Section 1. Why am I being given
COMIRNATY?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN COMIRNATY?
You should not be given COMIRNATY if you have had an allergic reaction
to any of the ingredients in COMIRNATY. See list at the
end of the CMI.
Check with your doctor if you have had: a severe allergic reaction or
breathing problems after any other vaccine or after being
given COMIRNATY in the past; fainted following any needle injection; a
severe illness or infection with high fever; a weakened
immune system or are on a medicine that affects your immune system; a
bleeding disorder, bruise easily or are on a blood
thinning medicine.
As with any vaccine, COMIRNATY may not fully protect all those who
receive it and it is not known how long you will be
protected.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am
given COMIRNATY?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your doctor or pharmacist if you are taking any other medicines,
including any medicines, vitamins or supplements that you
buy without a prescription. Tell your doctor or pharmacist if you have
recently received any other vaccine. For more information,
see Section 3. What if I am taking other medicines?
in the full CMI.
4.
HOW WILL I BE GIVEN COMIRNATY?
COMIRNATY will be given as an injection into the m

Toote omadused

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
COMIRNATY
®
(grey cap, do not dilute), new formulation, 0.1 mg/mL suspension for
injection, 12 years of age and older (30 micrograms/0.3 mL dose)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a multidose vial.
DO NOT DILUTE PRIOR TO USE
.
One vial (2.25 mL) contains 6 doses of 0.3 mL, see Section 4.2 Dose
and method of
administration and Section 6.6 Special precautions for disposal and
other handling.
1 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 severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Suspension for injection.
COMIRNATY is a white to off-white frozen suspension.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Active immunisation to prevent coronavirus disease 2019 (COVID-19)
caused by SARS-CoV-
2, in individuals 12 years of age and older.
The use of this vaccine should be in accordance with official
recommendations.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
INDIVIDUALS 12 YEARS OF AGE AND OLDER
COMIRNATY (grey cap, do not dilute) is administered intramuscularly as
a primary course of
2 doses (0.3 mL each) at least 21 days apart.
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BOOSTER DOSE IN INDIVIDUALS 12 YEARS OF AGE AND OLDER
A booster dose of COMIRNATY may be administered intramuscularly at
least 6 months after
the primary course in individuals 12 years of age and older.
The decision when and for whom to implement a booster dose of
COMIRNATY should be
made in accordance with official recommendations (see Sections 4.4
Special warnings and
precautions for use and 5.1 Pharmacodynamic properties).
INTERCHANGEABILIT