Regulatory Information
PHARMENG TECHNOLOGY PTE. LTD.
PHARMENG TECHNOLOGY PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INJECTION, SUSPENSION
**4.2 Posology and method of administration** Posology _Primary vaccination series_ _Individuals 12 years of age and older_ Nuvaxovid is administered intramuscularly as a course of 2 doses of 0.5 mL each. It is recommended to administer the second dose 3 weeks after the first dose (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Interchangeability_ There are no data available on the interchangeability of Nuvaxovid with other COVID-19 vaccines to complete the primary vaccination course. Individuals who have received a first dose of Nuvaxovid should receive the second dose of Nuvaxovid to complete the vaccination course. _Booster dose_ _Booster dose in individuals 18 years of age and older_ A booster dose of Nuvaxovid (0.5 mL) may be administered intramuscularly after the primary series of Nuvaxovid in individuals 18 years of age and older (homologous booster dose). The decision when and for whom to implement a booster dose of Nuvaxovid should be made based on available vaccine safety and effectiveness data, in accordance with official recommendations. _Paediatric population_ The safety and efficacy of Nuvaxovid in children aged less than 12 years have not yet been established. No data are available. _Elderly population_ No dose adjustment is required in elderly individuals ≥ 65 years of age. Method of administration Nuvaxovid is for intramuscular injection only, preferably into the deltoid muscle of the upper arm. Do not inject the vaccine intravascularly, subcutaneously, or intradermally. The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products. For precautions to be taken before administering the vaccine, see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. For instructions on handling and disposal of the vaccine, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
INTRAMUSCULAR
Medical Information
**4.1 Therapeutic indications** Nuvaxovid is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.
**4.3 Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
J07BN04
covid-19, protein subunit
Manufacturer Information
PHARMENG TECHNOLOGY PTE. LTD.
Serum Institute Of India Private Limited