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PELGRAZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.6ML [SIN16249P]
Active ingredients: PELGRAZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.6ML
Last updated 26 October 2025
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Product Info
PELGRAZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.6ML
[SIN16249P]
Product information
Active Ingredient and Strength | PEGFILGRASTIM - 6 MG/0.6 ML |
Dosage Form | INJECTION, SOLUTION |
Manufacturer and Country | INTAS PHARMACEUTICALS LIMITED BIOPHARM DIVISION - INDIA |
Registration Number | SIN16249P |
Licence Holder | ACCORD HEALTHCARE PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L03AA13 |
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).
4.2 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.
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.