Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, SOLUTION
**4.2 Posology and method of administration** Pelgraz therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. Posology One 6 mg dose (a single pre-filled syringe) of Pelgraz is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. Special populations Paediatric population The safety and efficacy of Pelgraz in children and adolescents has not yet been established. Patients with renal impairment No dose change is recommended in patients with renal impairment. Method of administration Pelgraz is for subcutaneous use. The injections should be given subcutaneously into the thigh, abdomen or upper arm. For instructions on handling of the medicinal product before administration, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
SUBCUTANEOUS
Medical Information
**4.1 Therapeutic indications** Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
**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_.
L03AA13
pegfilgrastim
Manufacturer Information
ACCORD HEALTHCARE PRIVATE LIMITED
Intas Pharmaceuticals Limited Biopharma Division
Active Ingredients
Documents
Package Inserts
Pelgraz Injection 6mg PI.pdf
Approved: June 24, 2021