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NEW ZEALAND DATA SHEET - Medsafe

Version: pfdcovii10622 Supersedes: pfdcovii10422 Page 1 of 25 NEW ZEALAND data SHEET 1. PRODUCT NAME COMIRNATY COVID-19 VACCINE mg/mL concentrated suspension for injection. (Purple cap, must dilute) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION This is a multidose vial and must be diluted before use. One vial ( mL) contains 6 doses of mL after dilution, see Section Dose and method of administration and Section Special precautions for disposal and other handling. 1 dose ( mL) contains 30 micrograms of tozinameran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles). The active ingredient is a single-stranded, 5 -capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders

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