Covid Solution

    Covid Solution

    S4
    PDF Leaflet Revision Date: 02 February 2022


    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Prevention of COVID-19 disease in adults and children over 18.

    Dosage (summary)

    0.5 ml intramuscular injection, two doses at 2-4 week intervals.

    Special Populations

    • Elderly
    • Immunocompromised

    Pregnancy & Breastfeeding

    Use with caution in pregnant and lactating mothers; consult a physician.

    Key Drug Interactions

    • No clinical trial data on combination with other vaccines
    • Inform physician of all medications

    Contraindications

    • Allergy to any component
    • Serious chronic disease
    • Acute fever or illness

    Common side effects

    • Pain at injection site
    • Transient fever
    • Fatigue
    • Headache
    • Diarrhea

    Counselling Points

    • Monitor for 30 mins post-vaccination
    • Do not use after expiration date
    • Store between 2u00b0C-8u00b0C

    Serious warnings

    • Intravascular injection prohibited
    • Emergency treatment for severe allergic reactions should be available
    • Caution in blood disorders and immune deficiencies
    Important Disclaimer

    The Covid Solution professional information leaflet below is the property of Mc Pharma and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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    Clinical Particulars

    Section 4 of the official insert — extracted exactly as issued, no alterations

    4.1 Therapeutic 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.

    4.2 Posology and method of administration

    Each vial contains 6.5U/0.5 ml of product for each administration by intramuscular injection, each dose contains 6.5U/0.5 ml of inactivated SARS-CoV-2 antigen.

    Immunization Program: This vaccine will be administered by a healthcare professional of national health authorities and CDC in accordance with the national immunization program and strategies. Method of Administration: The recommended administration is through intramuscular route, the injection into a muscle will be preferably performed in the upper part of the arm. Immunization Program and Dosage: Two successive doses at an interval of 2-4 weeks, each dose is 0.5ml. The immune persistence study of this vaccine has not been conducted currently.

    4.3 Contraindications

    This vaccine is strictly prohibited in the following cases:

    • Individuals who are allergic to any component (active, excipients) of this product, or those who have allergic reactions with this vaccine before.
    • Individuals who have serious chronic disease or history of hypersensitivity.
    • 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.
    • Like all vaccines, this product may not have 100% preventive effect for vaccine.
    • Do not use disinfectant to contact the vaccine when the protective cap is pulled off and injection.
    • This vaccine should be used immediately after opening.
    • Do not use after the expiration date stated on the box and on the label.
    • Keep away from reach of children.

    4.4 Special warnings and precautions for use

    (1) Intravascular injection is strictly prohibited.

    (2) Drugs and equipment such as epinephrine should be available for emergency treatment in the event of an occasional severe allergic reaction. The vaccine should be watched for at least 30 minutes after vaccination.

    (3) This vaccine should be used with caution if:

    • have blood disorders such as decrease in platelets (thrombocytopenia) or clotting disorders.
    • are taking a treatment that suppresses your immune defence or if you present with immune deficiency, the immune response to the vaccine may be reduced. In such cases it is recommended to postpone vaccination until the end of the treatment or to make sure the subject is well protected. If you have chronic immune deficiency, this vaccine may also be recommended even though the underlying disease may cause a limited immune response.
    • You have uncontrolled epilepsy and other progressive neurological disorders.

    Special Patient Group (Consult a medical practitioner):

    • Elderly or geriatric patients
    • Immunocompromised
    • Pregnant and lactating mothers

    4.8 Undesirable effects

    The occurrence rate for ADRs (CIOMS recommendation) can be presented as:

    • Very common: Pain at the injection site;
    • Common: Transient fever, fatigue, headache, diarrhea; redness, swelling, itching, and hardening at the injection site;
    • Uncommon: Skin rash at the injection site; nausea and vomiting, itching at the non-injection site, muscle pain, arthralgia, drowsiness, dizziness, etc.
    • No vaccine-related serious adverse reaction was observed. If there are any adverse reactions not mentioned above during the use of this vaccine, please inform the physician in time.

    4.5 Interactions with other medicines

    (1) The clinical trial results of this vaccine in combination with other routine vaccines have not yet been provided.

    (2) If any drugs are being taken or recently taken, including over the counter (OTC), please inform the physician in time.

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