Regulatory Information
MYLAN PHARMACEUTICALS PTE. LTD.
ZUELLIG PHARMA PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INJECTION, SOLUTION
**Posology and Method of Administration** Fulphila™ 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 Fulphila™ is recommended for each chemotherapy cycle, given at least 24 hours (not above 30°C) after cytotoxic chemotherapy. Special Populations _Paediatric population_ The safety and efficacy of Fulphila™ in children has not yet been established. Currently available data are described below but no recommendation on a posology can be made. _Patients with renal impairment_ No dose change is recommended in patients with renal impairment. Method of administration Fulphila™ is injected subcutaneously. The injections should be given into the thigh, abdomen or upper arm. For instructions on handling of the medicinal product before administration, refer to section "special warnings and precautions for use" – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
SUBCUTANEOUS
Medical Information
**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).
**Contraindications** Hypersensitivity to the active substance or to any of the excipients.
L03AA13
pegfilgrastim
Manufacturer Information
ZUELLIG PHARMA PTE. LTD.
Biocon Biologics India Limited