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Comirnaty

Comirnaty

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Bretovameran [COVID-19 mRNA vaccine (nucleoside modified, embedded in lipid nanoparticles)]
Indications/Uses
Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in infants & childn 6 mth to 4 yr (3 mcg/0.3 mL), childn 5-11 yr (10 mcg/0.3 mL) & individuals ≥12 yr (30 mcg/0.3 mL).
Dosage/Direction for Use
IM Inj in anterolateral aspect of thigh for infants 6 to <12 mth & anterolateral aspect of thigh or deltoid muscle for individuals ≥1 yr. Individuals ≥12 yr 30 mcg/0.3 mL as single dose regardless of prior COVID-19 vaccination status. Childn 5-11 yr 10 mcg/0.3 mL as single dose regardless of prior COVID-19 vaccination status. Infant & childn 6 mth to 4 yr w/o history of completion of COVID-19 primary course or prior SARS CoV-2 infection Primary course: 3 doses of 3 mcg/0.3 mL. Administer 2nd dose 3 wk after 1st dose, followed by 3rd dose at least 8 wk after 2nd dose, w/ history of completion of COVID-19 primary course or prior SARS CoV-2 infection 3 mcg/0.3 mL as single dose. Individuals previously vaccinated w/ COVID-19 Administer at least 3 mth after most recent dose of COVID-19 vaccine. Severely immunocompromised individuals ≥6 mth May administer additional doses in accordance w/ national recommendations.
Contraindications
Special Precautions
Hypersensitivity & anaphylaxis. Closely observe patients for at least 30 min following vaccination. Not to be inj intravascularly, SC or intradermally. Postpone vaccination in individuals suffering from acute severe febrile illness or acute infection. Presence of minor infection &/or low-grade fever should not delay vaccination. Increased risk of myocarditis & pericarditis following vaccination. Monitor patients developing symptoms indicative of myocarditis or pericarditis eg, acute & persisting chest pain, shortness of breath, or palpitations following vaccination. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions (eg, dizziness, palpitations, increases in heart rate, alterations in BP, paraesthesia, hypoaesthesia & sweating). Immunocompromised individuals. Patients w/ thrombocytopenia or any coagulation disorder (eg, haemophilia). May not protect all vaccine recipients; individuals may not be fully protected until 7 days after vaccination. Concomitant use w/ anticoagulant or immunosuppressant therapy. May temporarily affect ability to drive or use machines. Infants <6 mth. 3 mcg/0.3 mL: Not intended for individuals >5 yr.
Adverse Reactions
Headache; diarrhoea; arthralgia, myalgia; inj site pain & swelling, fatigue, chills, pyrexia. Lymphadenopathy; nausea, vomiting; inj site redness. Myocarditis & pericarditis. Erythema multiforme. 3 mcg/0.3 mL: Irritability; drowsiness; inj site tenderness.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BN01 - covid-19, RNA-based vaccine ; Belongs to the class of covid-19 vaccines.
Presentation/Packing
Form
Comirnaty inj 10 mcg/0.3 mL
Packing/Price
((multidose)) 2.25 mL x 10 × 1's; ((single dose)) 0.3 mL x 10 × 1's
Form
Comirnaty inj 30 mcg/0.3 mL
Packing/Price
((multidose)) 2.25 mL x 10 × 1's; ((single dose)) 0.3 mL x 10 × 1's
Form
Comirnaty conc for inj 3 mcg/0.3 mL
Packing/Price
((multidose)) 0.48 mL x 10 × 1's
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