Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Filgrastim 0.12mg
Pfizer New Zealand Limited
Filgrastim 0.12 mg
120 mcg/0.2mL
Solution for injection
Active: Filgrastim 0.12mg Excipient: Glacial acetic acid Nitrogen Polysorbate 80 Sodium hydroxide Sorbitol Water for injection
Syringe, glass, 0.2mL x, 1 dose unit
Prescription
Prescription
Hospira Zagreb d.o.o.
Established Cytotoxic Chemotherapy Nivestim is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Peripheral Blood Progenitor Cell Mobilisation (PBPC) Nivestim is indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy and the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic PBPC). Severe Chronic Neutropenia (SCN) Long term administration of Nivestim is indicated in patients, children or adults, with severe congenital, cyclic or idiopathic neutropenia with an Absolute Neutrophil Count (ANC) => HIV Infection Nivestim is indicated for the treatment of persistent neutropenia (ANC =>Latest Regulatory ActivityApplication DateApplication TypeChange(s)StatusPayment DatePriority6/12/2023Changed Medicine NotificationContraindications, warnings and precautions - G2; Administrative fee (CMN)Granted 9/1/202420/12/2023 13/4/2011New Higher-risk Medicine ApplicationAbridged new higher-risk medicine not containing a new active substanceGranted 24/5/201218/4/2011
Package - Contents - Shelf Life: Syringe, glass, 0.2mL x - 1 dose units - 15 days not refrigerated stored at or below 25°C protect from light. do not return to refrigeration 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 0.2mL x - 5 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 15 days not refrigerated stored at or below 25°C protect from light. do not return to refrigeration - Syringe, glass, 0.2mL x - 10 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 15 days not refrigerated stored at or below 25°C protect from light. do not return to refrigeration
2011-04-13
NIVESTIM ® 1 NIVESTIM ® _Filgrastim _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Nivestim. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Nivestim against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NIVESTIM IS USED FOR Nivestim solution for injection contains the active ingredient filgrastim. Filgrastim is a copy of a substance normally present in your body, called Granulocyte Colony Stimulating Factor or G-CSF. G-CSF is produced in the bone marrow and assists in the production of neutrophils, which are a type of white blood cell. Neutrophils help the body fight infections by surrounding and destroying the bacteria that cause them. G-CSF also helps neutrophils to be more effective. Nivestim does not cure the underlying illness but it is an important supportive therapy. Your doctor may have prescribed Nivestim because: • YOU ARE RECEIVING CHEMOTHERAPY FOR CANCER Some chemotherapy will reduce the number of neutrophils in your body. Although Nivestim is not a treatment for cancer, it does help the body to make new neutrophils, and this will reduce your chance of developing infections that might require treatment with antibiotics and/or hospital stays. Nivestim may also help to keep your chemotherapy treatment on schedule. • YOU ARE RECEIVING A BONE MARROW OR STEM CELL TRANSPLANT Blood cells are produced in the bone marrow and arise from special ‘parent’ cells, called stem cells. Some chemotherapy has toxic effects on bone marrow, so your doctor may choose to collect stem cells from your bone marrow or blood before you receive your chemotherapy or from a donor’s bone marrow or blood. These collected stem cells are then stored and ma Lugege kogu dokumenti
Version: pfdnivei11223 Supersedes: pfdnivei10323 Page 1 of 28 NEW ZEALAND DATA SHEET 1. PRODUCT NAME_ _ Nivestim ® 120 micrograms filgrastim in 0.2 mL, or 300 micrograms or 480 micrograms filgrastim in 0.5 mL Solution for Injection/Infusion (prefilled syringes). Nivestim is a biosimilar product. The prescribing physician should be involved in any decision regarding its interchangeability (refer to http://www.medsafe.govt.nz/profs/RIss/Biosimilars.asp). Nonclinical and clinical comparability studies using Nivestim and Neupogen ® are described in the Pharmacological Properties section of this datasheet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prefilled syringe of Nivestim contains 120 µg (equivalent to 12 million units) in 0.2 mL of solution for injection; or, 300 µg (equivalent to 30 million units) or 480 µg (equivalent to 48 million units) of filgrastim in 0.5 mL of solution for injection. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection/Infusion (prefilled syringes). Nivestim is a sterile, clear, colourless solution, practically free from particles, for subcutaneous (SC) or intravenous (IV) injection or infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ESTABLISHED CYTOTOXIC CHEMOTHERAPY Nivestim is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. PERIPHERAL BLOOD PROGENITOR CELL MOBILISATION (PBPC) Nivestim is indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following my Lugege kogu dokumenti