Information_for_healthcare_professionals.pdf

(361 KB) Pobierz
REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS
1
This medicinal product does not have a UK marketing authorisation but has been given
authorisation for temporary supply by the UK Department of Health and Social Care and the
Medicines & Healthcare products Regulatory Agency for active immunization to prevent
COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years of age and over.
As with any new medicine in the UK, this product will be closely monitored to allow quick
identification of new safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a multidose vial and must be diluted before use. 1 vial (0.45 mL) contains 5 doses of
30 micrograms of BNT162b2 RNA (embedded in lipid nanoparticles).
COVID-19 mRNA Vaccine BNT162b2 is highly purified single-stranded, 5’-capped messenger RNA
(mRNA) produced by cell-free
in vitro
transcription from the corresponding DNA templates, encoding
the viral spike (S) protein of SARS-CoV-2.
Excipients with known effect:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for injection.
The vaccine is a white to off-white frozen solution.
4.
4.1
CLINICAL PARTICULARS
Therapeutic indications
Active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of
age and older.
The use of COVID-19 mRNA Vaccine BNT162b2 should be in accordance with official guidance.
4.2
Posology and method of administration
Posology
Individuals 16 years of age and older
COVID-19 mRNA Vaccine BNT162b2 is administered intramuscularly after dilution as a series of
two doses (0.3 mL each) 21 days apart (see section 5.1).
There are no data available on the interchangeability of COVID-19 mRNA Vaccine BNT162b2 with
other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose
of COVID-19 mRNA Vaccine BNT162b2 should receive a second dose of COVID-19 mRNA
Vaccine BNT162b2 to complete the vaccination series.
Individuals may not be protected until at least 7 days after their second dose of the vaccine.
2
For further information on efficacy, see section 5.1.
Paediatric population
The safety and efficacy of COVID-19 mRNA Vaccine BNT162b2 in children under 16 years of age
have not yet been established.
Method of administration
Administer the COVID-19 mRNA Vaccine BNT162b2 vaccine intramuscularly in the deltoid muscle
after dilution.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
Preparation: The multidose vial is stored frozen and must be thawed prior to dilution.
Frozen vials should be transferred to 2 °C to
8 °C to thaw; a 195 vial pack may take 3 hours
to thaw (see section 6.4). Alternatively, frozen
vials may also be thawed for 30 minutes at
temperatures up to 25 °C for immediate use.
Once thawed, the undiluted vaccine can be
stored for up to 5 days at 2 °C to 8 °C, and up to
2 hours.at temperatures up to 25 °C.
Allow the thawed vial to come to room
temperature and gently invert 10 times prior to
dilution. Do not shake. Prior to dilution the
vaccine should present as an off-white solution
with no particulates visible. Discard the vaccine
if particulates or discolouration are present.
The thawed vaccine must be diluted in its
original vial with 1.8 mL sodium chloride
9 mg/mL (0.9%) solution for injection, using a
21 gauge or narrower needle and
aseptic
techniques.
Warning:
Unpreserved sodium chloride
9 mg/mL (0.9%) solution for injection is the
only
diluent that should be used. This diluent is
not provided in the vaccine carton.
3
Equalise vial pressure before removing the
needle from the vial by withdrawing 1.8 mL air
into the empty diluent syringe.
Gently invert the diluted solution 10 times. Do
not shake.
The diluted vaccine should present as an off-
white solution with no particulates visible.
Discard the diluted vaccine if particulates or
discolouration are present.
The diluted vials should be marked with the
dilution date and time and stored between 2 °C
to 25 °C.
Use immediately, and within 6 hours after
dilution.
After dilution, the vial contains 5 doses of
0.3 mL. Withdraw the required 0.3 mL dose of
diluted vaccine using a sterile needle and
syringe and discard any unused vaccine within
6 hours after dilution.
4
For instructions on disposal see section 6.6.
4.3
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4
Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number
of the administered product should be clearly recorded.
General recommendations
As with all injectable vaccines, appropriate medical treatment and supervision should always be
readily available in case of a rare anaphylactic event following the administration of the vaccine.
The administration of COVID-19 mRNA Vaccine BNT162b2 should be postponed in individuals
suffering from acute severe febrile illness.
Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate
intramuscular injection, should not be given the vaccine unless the potential benefit clearly outweighs
the risk of administration.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have
a diminished immune response to the vaccine. No data are available about concomitant use of
immunosuppressants.
As with any vaccine, vaccination with COVID-19 mRNA Vaccine BNT162b2 may not protect all
vaccine recipients.
No data are available on the use of COVID-19 mRNA Vaccine BNT162b2 in persons that have
previously received a full or partial vaccine series with another COVID-19 vaccine.
Excipient information
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium‑free’.
4.5
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concomitant administration of COVID-19 mRNA Vaccine BNT162b2 with other vaccines has not
been studied (see section 5.1).
Do not mix COVID-19 mRNA Vaccine BNT162b2 with other vaccines/products in the same syringe.
4.6
Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of COVID-19 mRNA Vaccine BNT162b2.
Animal reproductive toxicity studies have not been completed. COVID-19 mRNA Vaccine
BNT162b2 is not recommended during pregnancy.
For women of childbearing age, pregnancy should be excluded before vaccination. In addition, women
of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.
5

Plik z chomika:

Inne pliki z tego folderu:

Inne foldery tego chomika:

Zgłoś jeśli naruszono regulamin