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COVISHIELD™ Corona Virus Vaccine (Recombinant)

Home  /  COVID-19   /  COVISHIELD™ Corona Virus Vaccine (Recombinant)

COVISHIELD™ Corona Virus Vaccine (Recombinant)

Last Updated on 1 year by Dan

1 NAME OF THE MEDICINAL PRODUCT COVISHIELDTM
ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant)

2 QUALITATIVE AND QUANTITATIVE COMPOSITIONpage1image139528

One dose (0.5 ml) contains:
ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant)

5 × 1010 viral particles (vp)
*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike (S) glycoprotein.

Produced in genetically modified human embryonic kidney (HEK) 293 cells.
This product contains genetically modified organisms (GMOs).
For the full list of excipients, see section 6.1.
Both COVISHIELDTM (manufactured by Serum Institute of India Pvt Ltd) and COVID-19 Vaccine AstraZeneca (manufactured by AstraZeneca) are ChAdOx1 nCoV- 19 Corona Virus Vaccines (Recombinant).

3 PHARMACEUTICAL FORM

Solution for injection

The solution is colourless to slightly brown, clear to slightly opaque and particle free with a pH of 6.6.

4 CLINICAL PARTICULARS

4.1 Therapeuticindications

COVISHIELDTM is indicated for active immunisation of individuals ≥18 years old for the prevention of coronavirus disease 2019 (COVID-19).

4.2 Posologyandmethodofadministration

Posology
COVISHIELDTM vaccination course consists of two separate doses of 0.5 ml each. The second dose should be administered

between 4 to 6 weeks after the first dose. However, there is data available for administration of the second dose up to 12 weeks after the first dose from the overseas studies (see section 5.1).
It is recommended that individuals who receive a first dose of COVISHIELDTM complete the vaccination course withCOVISHIELDTM (see section 4.4).

Special populations

Elderly population

Efficacy and safety data are currently limited in individuals ≥ 65 years of age (see sections 4.8 and 5.1). No dosage adjustment is required in elderly individuals ≥ 65 years of age.

Paediatric population

The safety and efficacy of COVISHIELDTM in children and adolescents (aged <18 years old) have not yet been established. No data are available.

Method of administration
COVISHIELDTM is for intramuscular (IM) injection only, preferably in the deltoid muscle.
For instructions on administration, 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 Specialwarningsandspecialprecautionsforuse
Hypersensitivity
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Concurrent illness
As with other vaccines, administration of COVISHIELDTM should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, and/or low-grade fever should not delay vaccination.
Thrombocytopenia and coagulation disorders
As with other intramuscular injections, COVISHIELDTM should be given with caution to individuals with thrombocytopenia, any coagulation disorder or to persons on anticoagulation therapy, because bleeding or bruising may occur following an intramuscular administration in these individuals.
Immunocompromised individuals
It is not known whether individuals with impaired immune responsiveness, including individuals receiving immunosuppressant therapy, will elicit the same response as immunocompetent individuals to the vaccine regimen. Immunocompromised individuals may have relatively weaker immune response to the vaccine regimen.
Duration and level of protection
The duration of protection has not yet been established.
As with any vaccine, vaccination with COVISHIELDTM may not protect all vaccine recipients (See section 5.1). Interchangeability
No data are available on the use of ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) in persons that have previously received partial vaccine series with another COVID-19 vaccine.
4.5 Interactionwithothermedicinalproductsandotherformsofinteraction
No interaction studies have been performed.
Concomitant administration of COVISHIELDTM with other vaccines has not been studied (see section 5.1)
4.6 Fertility,pregnancyandlactation
Fertility
Preliminary animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Pregnancy
There is a limited experience with the use of ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant) in pregnant women. Preliminary animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryofetal development, parturition or postnatal development; definitive animal studies have not been completed yet. The full relevance of animal studies to human risk with vaccines for COVID-19 remains to be established.
Administration of COVISHIELDTM in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.

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