ZIEXTENZO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.6ML [SIN17604P]
Active ingredients: PEGFILGRASTIM
Product Info
ZIEXTENZO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.6ML
[SIN17604P]
Product information
Active Ingredient and Strength | PEGFILGRASTIM - 6 MG/0.6 ML |
Dosage Form | INJECTION, SOLUTION |
Manufacturer and Country | NOVARTIS PHARMACEUTICAL MANUFACTURING GMBH - AUSTRIA |
Registration Number | SIN17604P |
Licence Holder | SANDOZ SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L03AA13 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
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).
Dosing
4.2 Posology and method of 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.
Ziextenzo therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Special populations
Pediatric Use
There are insufficient data to recommend the use of pegfilgrastim in children and adolescents under 18 years of age.
Geriatric Use
See section 5.2 (Pharmacokinetics in Special Populations) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Renal Impairment
See section 5.2 (Pharmacokinetics in Special Populations) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Hepatic Impairment
See section 5.2 (Pharmacokinetics in Special Populations) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Method of administration
Ziextenzo is for subcutaneous use.
Contraindications
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.
