Neupogen

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Filgrastim 960 µg/mL (480 µg/syringe);  

Tilgjengelig fra:

Amgen New Zealand Limited

INN (International Name):

Filgrastim 960 µg/mL (480 µg/syringe)

Dosering :

480 mcg/0.5mL

Legemiddelform:

Solution for injection

Sammensetning:

Active: Filgrastim 960 µg/mL (480 µg/syringe)   Excipient: Glacial acetic acid Polysorbate 80 Sodium hydroxide Sorbitol Water for injection

Enheter i pakken:

Syringe, glass, Prefilled, 1 x 0.5 mL, plus needle, 0.5 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Amgen Manufacturing Ltd

Indikasjoner:

Neupogen 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 Neupogen are similar in adults and children receiving cytotoxic chemotherapy. Neupogen is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 10^9/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections, when other options to manage neutropenia are inappropriate.

Produkt oppsummering:

Package - Contents - Shelf Life: Syringe, glass, 0.5 mL - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisasjon dato:

2004-08-17

Informasjon til brukeren

Neupogen

CMI 221219
1
CONSUMER MEDICINE INFORMATION
NEUPOGEN
®
FILGRASTIM
300 MCG IN 0.5 ML AND 480 MCG IN 0.5 ML (PREFILLED SYRINGES) AND 300
MCG IN
1 ML (VIALS)
SOLUTION FOR INJECTION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about NEUPOGEN.
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 NEUPOGEN
against the benefits expected 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 NEUPOGEN IS USED FOR
NEUPOGEN 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.
NEUPOGEN does not cure the
underlying illness but it is an important supportive therapy.
Your doctor may have prescribed NEUPOGEN because:

YOU ARE RECEIVING CHEMOTHERAPY FOR CANCER
Some chemotherapy will reduce the number of neutrophils in your body.
Although NEUPOGEN 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.
NEUPOGEN 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

Preparatomtale

NEW ZEALAND DATA SHEET
Neupogen New Zealand Data Sheet
Page 1 of 31
1.
NEUPOGEN
®
Neupogen 300 mcg/mL solution for injection vial
Neupogen 300 mcg/0.5mL solution for injection pre-filled syringe (not
available)
Neupogen 480 mcg/0.5mL solution for injection pre-filled syringe (not
available)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe of Neupogen contains 300 mcg (equivalent to 30
million units) or
480 mcg (equivalent to 48 million units) of filgrastim in 0.5 mL of
solution for injection.
Each vial of Neupogen contains 300 mcg (equivalent to 30 million
units) of filgrastim in
1 mL of solution for injection.
Filgrastim is produced in a laboratory strain of Escherichia coli
bacteria which has been
genetically altered by the addition of a gene for the
granulocyte-colony stimulating factor.
Excipient(s) with known effect
This medicine contains 25 mg sorbitol (E420) in each 300 and 480
microgram prefilled
syringe.
This medicine contains 50 mg sorbitol (E420) in each 300 microgram
vial.
This medicine contains less than 1 mmol sodium (23 mg) per 300 and 480
microgram
prefilled syringes and per 300 microgram vial, that is to say
essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Neupogen is a sterile, clear, colourless solution for injection,
practically free from
particles, for subcutaneous (SC) or intravenous (IV) injection.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Established Cytotoxic Chemotherapy
Neupogen 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
NEW ZEALAND DATA SHEET
Neupogen New Zealand Data Sheet
Page 2 of 31
considered to be at increased risk of prolonged