Nivestim

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Filgrastim 0.12mg

Tilgjengelig fra:

Pfizer New Zealand Limited

INN (International Name):

Filgrastim 0.12 mg

Dosering :

120 mcg/0.2mL

Legemiddelform:

Solution for injection

Sammensetning:

Active: Filgrastim 0.12mg Excipient: Glacial acetic acid Nitrogen Polysorbate 80 Sodium hydroxide Sorbitol Water for injection

Enheter i pakken:

Syringe, glass, 0.2mL x, 1 dose unit

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Hospira Zagreb d.o.o.

Indikasjoner:

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 

Produkt oppsummering:

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

Autorisasjon dato:

2011-04-13

Informasjon til brukeren

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

Preparatomtale

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