Thrombolytic Therapy (Thrombolysis): Acute Myocardial Infarction: Nursing Considerations

 COVISHIELD

Name of the medical product: COVISHIELD

• ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant)

Qualitative and Quantitative Composition

• One dose (0.5 ml) contains:
• ChAdox1 nCoV-19 cORONA Virus Vaccine (Recombinant) 5 Х 10¹° 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)

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

Clinical Particulars

Therapeutic indications

• COVISHIELD is indicated for active immunisation of individuals ≥18 years old for the prevention of coronavirus disease 2019 

posology and method of administration

• COVISHIELD 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. 
• It is recommended that individuals who receive a first dose of COVISHIELD complete the vaccination course with COVISHIELD.
• Special population
• Elderly population: Efficacy and safety data are currently limited in individuals ≥65 years of age. No dose adjustment is required in elderly individuals ≥65 years of age.
• Paediatric population: The safety and efficacy of COVISHIELD in children and adolescents ( aged <18 years old) have not been established.

Method of administration

•   COVISHIELD is for intramuscular (IM) injection only, preferably in the deltoid muscle. 

Thrombolytic Therapy (Thrombolysis): Acute Myocardial Infarction: Nursing Considerations

Contraindications

• Hypersensitivity: As with 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 COVISHIELD should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold and low-grade fever should not delay vaccination.
• Thrombocytopenia and coagulation disorders: As with other intramuscular injections, COVISHIELD 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.

Interaction with other medicinal products and other forms of interaction

• No interaction studies have been performed.

Fertility, pregnancy and lactation

• Fertility: Preliminary animal studies do not indicate direct harmful effects with respect to fertility.
• Pregnancy: There is limited experience with the use of ChAdOx1 nCoV-19 Coronavirus 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. Administration of COVISHIELD in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
• Breastfeeding: It is unknown whether COVISHIELD is excreted in human milk.

Mechanism of action

• COVISHIELD is a monovalent vaccine composed of a single recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of SARS-CoV-2, Following administration, the S glycoprotein of SARS-CoV-2 is expressed locally stimulating neutralizing and cellular immune responses.

Overdose

• Experience of overdose is limited. There is no specific treatment for an overdose with ChAdOx nCoV-19 Corona Virus Vaccine (Recombinant). In the event of an overdose, the individual should be monitored and provided with symptomatic treatment as appropriate.

Incompatibilities

• In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.

Shelf-life

• The expiry date of vaccine is indicated on the label and packaging. Once opened, multi-dose vials should be used as soon as practically possible and within 5 hours when kept between +2 °C and +25°C. All opened multidose vials of COVISHIELD should be discarded at the end of immunization session or within six hours whichever comes first.

Special Precautions for storage 

• Store in a refrigerator (+2°C to +8°C)
• Do not freeze. Protect from light.

Instructions for use, handling and disposal

• COVISHILED is a colourless to slightly brown, clear tp slightly opaque solution. The vaccine should be inspected visually prior to administration and discarded if particulate matter or differences in the described appearance are observed.
• Do not shake the vial: Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection to be administered intramuscularly. Use separate sterile needle and syringe for each individual. It is normal for liquid to remain in the vial after withdrawing the final dose. The vaccine does not contain ant preservative. Aseptic technique should be used for withdrawing the dose for administration. To facilitate the traceability of the vaccine, the name and the batch number of the administered product must be recorded for each recipient.
• COVISHIELD contain genetically modified organisms (GMOs). Any unused vaccine or waste material should be disposed of in accordance with local requirements. Spills should be disinfected with an appropriate antiviral disinfectant ( e.g Hydrogen peroxide-based disinfectants).