Details for: COVISHIELD - COVID-19
Company: VERITY PHARMACEUTICALS INC.
|DIN||DIN name||Active Ingredient(s)||Strength||Dosage Form||Route of Administration|
|02512947||COVISHIELD||CHADOX1-S [RECOMBINANT]||50000000000 VP / 0.5 ML||SOLUTION||INTRAMUSCULAR|
Regulatory Decision Summary
Summary Safety Review - AstraZeneca and COVISHIELD COVID-19 Vaccines - Assessing the Potential Risk of Thrombosis in combination with Thrombocytopenia
Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Public Release of Clinical Information - COVISHIELD
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
COVISHIELD is a vaccine used to prevent the coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus. It can be given to adults 18 years of age and older.
What it does
COVID-19 is caused by a virus called coronavirus (SARS-CoV-2).
COVISHIELD stimulates the body’s natural defences (immune system), by causing the body to produce its own protection (antibodies) against the SARS-CoV-2 virus that causes the COVID-19 infection. You cannot get COVID-19 from this vaccine.
The vaccine is given by injection with a needle usually in the upper arm, and will require two doses given between 4 and 12 weeks apart. Individuals may not be optimally protected until after receiving the second dose of the vaccine. As with any vaccine, COVISHIELD may not fully protect all those who receive it. It is not yet known how long people who receive the vaccine will be protected.
Even after you have had both doses of the vaccine, continue to follow the recommendations of local public health officials to prevent spread of COVID-19.
When it should not be used
You should not receive COVISHIELD if you:
- Had a severe allergic reaction to any of the medicinal ingredients or any of the other ingredients in this vaccine (see What the medicinal ingredient is and What the non-medicinal ingredients are). If you are not sure, talk to your healthcare professional;
- Have had an allergic reaction to a previous dose of COVISHIELD/AstraZeneca COVID-19 Vaccine;
- Have had a major blood clot occurring at the same time as having low levels of platelets (thrombocytopenia) after receiving COVISHIELD/ AstraZeneca COVID-19 Vaccine;
- Have previously experienced episodes of capillary leak syndrome (see Side effects and what to do about them);
- Have any symptoms that could be due to COVID-19. Talk with your healthcare professional about your symptoms and getting a COVID-19 test. Your healthcare professional will advise you when you are able to receive the vaccine.
What the medicinal ingredient is
Medicinal ingredients: COVID-19 Vaccine ChAdOx1-S [recombinant]
What the non-medicinal ingredients are
- Disodium edetate dihydrate (EDTA),
L-Histidine hydrochloride monohydrate,
- Magnesium chloride hexahydrate,
- Polysorbate 80,
- Sodium chloride,
- Water for injection
What dosage form it comes in
Colourless to slightly brown, clear to slightly opaque solution essentially free from visible particles, preservative-free, solution for injection. It is provided in a multiple dose vial of 10 doses; one dose is 0.5 mL.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take COVISHIELD. Talk about any health conditions or problems you may have, including if you:
- Have any allergies or previous problems following administration of COVISHIELD/AstraZeneca Covid-19 Vaccine such as an allergic reaction or breathing problems, or major venous or arterial thrombosis with thrombocytopenia;
- Have ever had a blood clot or low blood platelets (thrombocytopenia) in the past or if you have an autoimmune disorder (illness where the body’s immune system attacks its own cells) including idiopathic thrombocytopenic purpura (ITP);
- Have had a history of venous sinus thrombosis in the brain (CVST) with low blood platelets (thrombocytopenia) or a history of heparin-induced thrombocytopenia (HIT);
- Have had previously experienced episodes of capillary leak syndrome (see Side effects and what to do about them);
- Have had a severe allergic reaction after any other vaccine injection
- Have a weakened immune system due to a medical condition (immunodeficiency) or are on a medicine that affects your immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)
- Currently have a severe infection with a high temperature (over 38°C);
- Have a problem with bleeding or bruising, or if you are taking a blood thinning medicine (anticoagulant);
- Are pregnant, think you may be pregnant or plan to become pregnant.
- Are breastfeeding or plan to breastfeed.
If you are not sure if any of the above applies to you, talk to your healthcare professional before you are given the vaccine.
Guillain-Barré syndrome (GBS) is a neurological disorder where inflammation of peripheral nerves causes rapid muscle weakness and can sometimes lead to paralysis. This has been reported very rarely after vaccination with COVISHIELD/AstraZeneca COVID-19 Vaccine. Seek immediate medical attention if you develop weakness and paralysis in the extremities that can progress to the chest and face.
Driving and using machines
COVISHIELD has no known effect on the ability to drive and use machines. However, side effects listed in Side effects and what to do about them may impact your ability to drive and use machines. If you feel unwell, do not drive or use machines.
Interactions with this medication
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Tell your healthcare professional if you are taking, have recently taken or might take, any other medicines or vaccines.
Proper use of this medication
How COVISHIELD is given:
- A healthcare provider will inject the vaccine into a muscle (intramuscular injection), usually in your upper arm.
- During and after each injection of the vaccine, your doctor, pharmacist or nurse will watch over you for around 15 minutes to monitor for signs of an allergic reaction.
You will receive 2 injections. You will be told when you need to return for your second injection.
The second injection can be given between 4 and 12 weeks after the first injection.
It is very important that you return for the second injection, or the vaccine may not work as well.
Individuals should complete the vaccination course with either COVISHIELD or AstraZeneca COVID-19 Vaccine.
In the event of suspected overdose with COVISHIELD, contact your regional poison control centre.
If you forget to go back to your healthcare professional at the scheduled time for your next
dose, ask your healthcare professional for advice. It is important that you return for your second injection.
Side effects and what to do about them
Like all medicines, COVISHIELD can cause side effects, although not everybody gets them. Most side-effects are mild to moderate in nature and resolve within a few days. Fewer side effects are reported after the second dose.
Severe allergic reaction (anaphylaxis), severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing or breathing) have been reported following COVISHIELD and/or AstraZeneca COVID-19 Vaccine. Should you develop any serious symptoms or symptoms that could be an allergic reaction, seek medical attention right away. Symptoms of an allergic reaction include:
- hives (bumps on the skin that are often very itchy)
- feeling faint or light-headed
- changes in your heartbeat
- swelling of your face, lips, tongue or throat
- difficulty breathing, shortness of breath or wheezing
A combination of blood clots and low level of platelets, in some cases together with bleeding, have been observed very rarely following vaccination with COVISHIELD and/or AstraZeneca COVID-19 Vaccine in post-authorization use. The majority of the cases occurred within the first 3 weeks following vaccination and some cases had a fatal outcome. Very rare cases of low blood platelets (thrombocytopenia) have also been reported. Seek medical attention right away if any of the following symptoms occur within the first month following vaccination:
- new severe headaches, worsening or persistent headaches, blurred vision, confusion or seizures;
- shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal pain;
- unusual skin bruising or pinpoint round spots beyond the site of vaccination.
After vaccination, you may have more than one side effect at the same time (for example, muscle/joint aches, headaches, chills and generally feeling unwell). If any of your symptoms are persistent, please seek advice from your healthcare professional.
Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVISHIELD and/or AstraZeneca COVID-19 Vaccine. Some affected patients had a previous diagnosis of CLS. CLS is a serious, potentially fatal condition causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint (low blood pressure). Seek medical attention right away if you develop these symptoms in the days following vaccination.
Side effects that have been reported with COVISHIELD were as follows:
Very Common (may affect more than 1 in 10 people)
- tenderness, pain, warmth or itching where the injection is given
- generally feeling unwell
- feeling tired (fatigue)
- chills or feeling feverish
- feeling sick (nausea)
- joint pain or muscle ache
Common (may affect up to 1 in 10 people)
- swelling or redness where the injection is given
- being sick (vomiting) or diarrhea
- pain in legs or arms
- flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills
Uncommon (may affect up to 1 in 100 people)
- sleepiness or feeling dizzy
- decreased appetite
- abdominal pain
- enlarged lymph nodes
- excessive sweating, itchy skin, rash or hives
These are not all the possible side effects you may have when taking COVISHIELD. If you experience any side effects not listed here, tell your healthcare professional.
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
How to store
Your healthcare professional is responsible for storing this vaccine and disposing of any unused product correctly.
Keep out of reach and sight of children.
Reporting side effects
Reporting Suspected Side Effects for Vaccines
For the general public: Should you experience a side effect following immunization, please report it to your healthcare professional.
Should you require information related to the management of the side effect, please contact your healthcare professional. The Public Health Agency of Canada, Health Canada and Verity Pharmaceuticals Inc. cannot provide medical advice.
For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-following-immunization/form.html ) and send it to your local Health Unit.
COVISHIELD (manufactured by Serum Institute of India) and AstraZeneca COVID-19 VACCINE (manufactured by AstraZeneca) are ChAdOx1-S recombinant vaccines developed by AstraZeneca and the University of Oxford. Health Canada has reviewed the manufacturing information for these vaccines and found them to be comparable.
Health Canada has authorized the sale of this COVID-19 vaccine under an Interim Order. This leaflet is a summary and will not tell you everything about this vaccine. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about COVISHIELD.
If you want more information about COVISHIELD:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.veritypharma.com, or www.covishield-canada.ca, or by calling 1-800-977-9778.
This leaflet was prepared by Verity Pharmaceuticals Inc., Mississauga, Ontario L4W 4Y9
© Verity Pharmaceuticals 2021. All rights reserved.
Last Revised August 13, 2021
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