- Approval Id
- f651a0e69c147ae9
- Drug Name
- FULPHILA™ SOLUTION FOR INJECTION IN PREFILLED SYRINGE 6MG/0.6ML
- Product Name
- FULPHILA™ SOLUTION FOR INJECTION IN PREFILLED SYRINGE 6MG/0.6ML
- Approval Number
- SIN16012P
- Approval Date
- 2020-09-21
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- ZUELLIG PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>Posology and Method of Administration</strong></p>
<p>Fulphila® therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.</p>
<p><u>Posology</u></p>
<p>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.</p>
<p><u>Special Populations</u></p>
<p><u><em>Paediatric population</em></u></p>
<p>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.</p>
<p><u><em>Patients with renal impairment</em></u></p>
<p>No dose change is recommended in patients with renal impairment.</p>
<p><u>Method of administration</u></p>
<p>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" – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>THERAPEUTIC INDICATIONS</strong></p>
<p>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).</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients.</p>
- Atc Code
- L03AA13
- Atc Item Name
- pegfilgrastim
- Pharma Manufacturer Name
- ZUELLIG PHARMA PTE. LTD.
