Neulastim

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Pegfilgrastim 10 mg/mL;  

Sẵn có từ:

Amgen New Zealand Limited

INN (Tên quốc tế):

Pegfilgrastim 10 mg/mL

Liều dùng:

6 mg/0.6mL

Dạng dược phẩm:

Solution for injection

Thành phần:

Active: Pegfilgrastim 10 mg/mL   Excipient: Acetic acid Polysorbate 20 Sodium hydroxide Sorbitol Water for injection

Các đơn vị trong gói:

Syringe, glass, prefilled + ss needle, 0.6 mL

Lớp học:

Prescription

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

Amgen Manufacturing Ltd

Chỉ dẫn điều trị:

Reduction in the duration of neutropenia, the incidence of febrile neutropenia and the incidence of infection as manifested by febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Syringe, glass, with stainless steel needle - 0.6 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Ngày ủy quyền:

2005-05-06

Tờ rơi thông tin

Neulastim
®
CMI
1 of 7
CONSUMER MEDICINE INFORMATION
NEULASTIM
®
PEGFILGRASTIM
6 MG OF PEGFILGRASTIM IN 0.6 ML (10 MG/ML) SOLUTION FOR INJECTION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about NEULASTIM.
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 NEULASTIM
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 NEULASTIM IS USED FOR
NEULASTIM solution for injection contains the active ingredient
pegfilgrastim.
Using gene technology, pegfilgrastim is produced in a specific type of
bacteria, called _E. coli_.
Pegfilgrastim is a long-acting form of recombinant human Granulocyte
Colony Stimulating Factor (G-
CSF). G-CSF is produced by the body in the bone marrow and assists in
the production of
neutrophils, which are a type of white blood cell. Neutrophils defend
the body against infection by
destroying bacteria in the blood.
NEULASTIM also helps neutrophils to be more effective.
Some chemotherapy medicines will reduce the number of neutrophils in
your body. Although
NEULASTIM is not a treatment for cancer, it is used following
chemotherapy to increase the number
of neutrophils. This will reduce your chance of developing infections
that might require treatment with
antibiotics and/or hospital stays. NEULASTIM may also help to keep
your chemotherapy treatment on
schedule.
NEULASTIM does not cure the underlying illness but it is an important
supportive therapy.
Your doctor, however, may have prescribed NEULASTIM for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY NEULASTIM HAS BEEN
PRESCRIBED FOR
YOU.
This medicine is available only with a doctor’s prescription.
Neulastim
®
CMI
2 of 7
BEFORE YOU USE NEULASTIM
_WHEN YOU MUST NOT USE IT _
DO NOT USE NEULASTIM IF:
1.
YOU HAV

Đặc tính sản phẩm

NEW ZEALAND DATA SHEET
NEULASTIM NEW ZEALAND DATA SHEET
PAGE 1 OF 15
1.
NEULASTIM (6 MG IN 0.6 ML SOLUTION FOR INJECTION)
Neulastim
®
6 mg
in 0.6 mL solution for injection (pre-filled syringe)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
6 mg of pegfilgrastim in 0.6 mL (10 mg/mL*) solution for injection.
The concentration is
20 mg/mL if the PEG moiety is included.
* Based on protein only.
Pegfilgrastim is composed of filgrastim (recombinant methionyl human
G-CSF) with a
20 kDa polyethylene glycol (PEG) molecule covalently bound to the
N-terminal
methionine residue. Filgrastim is produced by recombinant DNA
technology in
_E coli_ (K12).
Excipient(s) with known effect
Each pre-filled syringe contains 30 mg sorbitol (E420).
Each pre-filled syringe contains less than 1 mmol (_23_ mg) sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Neulastim is a clear, colourless solution for injection in a
pre-filled syringe.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction in the duration of neutropenia, the incidence of febrile
neutropenia and the
incidence of infection as manifested by febrile neutropenia in
patients treated with
cytotoxic chemotherapy for malignancy (with the exception of chronic
myeloid leukaemia
and myelodysplastic syndromes).
4.2
DOSE AND METHOD OF ADMINISTRATION
Neulastim therapy should be initiated and supervised by physicians
experienced in
oncology and/or haematology.
Dose
One 6 mg dose (a single pre-filled syringe) of Neulastim is
recommended for each
chemotherapy cycle, administered as a subcutaneous injection
approximately 24 hours
following cytotoxic chemotherapy.
NEW ZEALAND DATA SHEET
NEULASTIM NEW ZEALAND DATA SHEET
PAGE 2 OF 15
_Paediatric population _
The safety and efficacy of Neulastim in children aged below 18 years
have not yet been
established. Currently available data are described in section 5.2 but
no
recommendation on a dosage can be made.
Method of administration
Subcutaneous injection.
For instructions on handling the medicine before adminis