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HSA Approval

Neulastim Pre-filled Syringe 6mg/0.6ml

SIN13200P

Neulastim Pre-filled Syringe 6mg/0.6ml

Neulastim Pre-filled Syringe 6mg/0.6ml

April 20, 2006

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Regulatory Information

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Therapeutic

Prescription Only

Formulation Information

INJECTION, SOLUTION

**2.2 Dosage and Administration** Adults (≥ 18 years): One 6 mg dose (a single pre-filled syringe) of pegfilgrastim is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy. Neulastim therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.

SUBCUTANEOUS

Medical Information

**2.1 Therapeutic Indication(s)** Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

**2.3 Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 1.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.

L03AA13

pegfilgrastim

Manufacturer Information

AMGEN BIOTECHNOLOGY SINGAPORE PTE. LTD.

Amgen Manufacturing, Limited

Active Ingredients

Pegfilgrastim

6mg/0.6ml

Pegfilgrastim

Documents

Package Inserts

Neulastim Injection PI.pdf

Approved: June 21, 2021

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