COVID-19 VACCINE MC PHARMA INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

MC Pharma (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH 0,5 ml DOSE CONTAINS SARS-COV-2 VACCINE(VERO CELL) INACTIVATED 6,5 U

Authorization status:

Canceled

Patient Information leaflet

0000-03-2021
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS 4
PROPRIETARY NAME: COVID-19 VACCINE MC PHARMA INTRAMASCULAR INJECTION
Read all this leaflet carefully before you are given COVID-19 VACCINE
MC PHARMA
_•_
_Keep this leaflet. You may need to read it again._
_•_
_If you have further questions, please ask your doctor, pharmacist,
nurse or other health care provider._
_•_
_If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects _
_not listed in this leaflet_
Read all of this leaflet carefully because it contains important
information for you
COVID-19 VACCINE MC PHARMA is available upon recommendation by your
doctor/pharmacist for you to
prevent COVID-19 caused by the SARS-CoV-2 virus
What is in this leaflet
_1. What COVID-19 VACCINE MC PHARMA is and what it is used for_
_2. What you need to know before you are given COVID-19 VACCINE MC
PHARMA_
_3. How is COVID-19 VACCINE MC PHARMA given_
_4. Possible side effects_
_5. How to store COVID-19 VACCINE MC PHARMA_
_6. Contents of the pack and other information_
1. What COVID-19 VACCINE MC PHARMA is and what it is used for
_COVID-19 VACCINE MC PHARMA is a vaccine used for preventing COVID-19
caused by the SARS-CoV-2 virus._
_COVID-19 VACCINE MC PHARMA is given to adults aged 18 years and
older._
_The vaccine causes the immune system (the body's natural defenses) to
produce antibodies and specialised white _
_blood cells that work against the virus, so giving protection against
COVID-19._
_None of the ingredients in this vaccine can cause COVID-19_
2. What you need to know before you are given COVID-19 VACCINE MC
PHARMA
_Do not have the vaccine if_
_• You are allergic to the active substance or any of the other
ingredients of this vaccine (listed in section 6)._
_• You have a previous diagnosis of blood disorders._
Warnings and precautions
_Talk to your doctor, pharmacist or nurse before you are givenCOVID-19
VACCINE MC PHARMA if:_
_•_
_you have ever had a severe allergic reaction after injectio

Summary of Product characteristics

SCHEDULING STATUS
PROPRIETARY NAME
COVID-19 VACCINE MC PHARMA
(AND DOSAGE FORM)
INTRAMASCULAR INJECTION
COMPOSTION
The COVID-19 VACCINE MC PHARMA SARS-CoV-2 Vaccine (Vero Cell),
inactivated is formulated with
SARS-CoV-2 strain, which is inoculated on the Vero cells for
culturing, virus harvesting, [-
propiolactone-inactivation, concentration and purification, then
adsorbed with aluminum
adjuvant to form the liquid vaccine.
ACTIVE COMPOSITION: SARS-CoV-2 (inactivated)
EXCIPIENTS: Disodium hydrogen phosphate (dodecahydrate), Sodium
chloride, Sodium dihydrogen
phosphate (monohydrate), Aluminum hydroxide adjuvant
PHARMACOLOGICAL CLASSIFICATION
A 30.5 Other
ATC code: J07BX03
PHARAMACOLOGICAL ACTION
SARS-CoV-2 Vaccine (Vero Cell), Inactivated
Please read the instructions carefully and use under the guidance of a
physician
S4
02022022
Pretoria
18H20
INDICATIONS:
The antibodies against the SARS-CoV-2 can be produced after
vaccination, to prevent the COVID-19
disease.
This product is used for adults and children over 18 years old,
particularly for medical personnel and
those in close contact with the virus. CONTRAINDICATION:
This vaccine is strictly prohibited in the following cases:
(1) Individuals who are allergic to any component (active, excipients)
of this product, or those who
have allergic reactions with this vaccine before.
(2) Individuals who have serious chronic disease or history of
hypersensitivity.
(3) Vaccination should be postponed if individuals have fever or
during the acute phase of disease.
because of the risk of bleeding which may occur during intramuscular
administration of the vaccine.
(4) Like all vaccines, this product may not have 100% preventive
effect for vaccine.
(5) Do not use disinfectant to contact the vaccine when the protective
cap is pulled off and injection.
(6) This vaccine should be used immediately after opening.
(7) Do not use after the expiration date stated on the box and on the
label.
Keep away from reach of children
02022022
Pretoria
18H20
WARNINGS
(1) Intravascular injection