Pfizer (Australia) ETOPOSIDE 100mg/5mL injection vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

etoposide, Quantity: 20 mg/mL

제공처:

Pfizer Australia Pty Ltd

약제 형태:

Injection, concentrated

구성:

Excipient Ingredients: polysorbate 80; ethanol absolute; macrogol 300; citric acid

관리 경로:

Intravenous

패키지 단위:

5mL x 10, 5mL x 1

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

INDICATIONS AS AT 3 April 1996: Etoposide Injection is indicated for the following: Small cell carcinoma of the lung. Acute monocytic and myelomonocytic leukaemia. Hodgkin's disease. Non-Hodgkin's lymphoma

제품 요약:

Visual Identification: Clear, colourless to straw coloured solution, free from visible defects.; Container Type: Vial; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

1991-08-13

환자 정보 전단

ETOPOSIDE INJECTION
_Etoposide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Etoposide Injection.
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 Etoposide
Injection against the benefits they
expect it will have for you.
This medicine is likely to be used
while you are in hospital. If possible,
please read this leaflet carefully
before this medicine is given to you.
In some cases this leaflet may be
given to you after the medicine has
been used.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ETOPOSIDE
INJECTION IS USED FOR
Etoposide belongs to a group of
anticancer drugs known as
epipodophyllotoxins. Etoposide is
active against a number of cancers,
including small cell carcinoma of the
lung, as well as cancers of blood cells
such as acute monocytic and
myelomonocytic leukaemia,
Hodgkin's disease, and Non-
Hodgkin's lymphoma.
It works by preventing the growth of
cancer cells and eventually
destroying them.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
ETOPOSIDE INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT HAVE ETOPOSIDE INJECTION IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
etoposide
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT HAVE ETOPOSIDE INJECTION IF
YOU HAVE ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
liver disease
•
severe bone marrow failure
•
severe infec

제품 특성 요약

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AUSTRALIAN
PRODUCT
INFORMATION
–
ETOPOSIDE (ETOPOSIDE)
1.
NAME OF THE MEDICINE
Etoposide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Etoposide Injection is a sterile solution containing etoposide 20
mg/mL in an organic solvent
base.
Excipients with known effect: Ethanol
_ _
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Concentrate for Solution for Infusion
Etoposide is a white or almost white, crystalline powder, practically
insoluble in water,
sparingly soluble in methanol, slightly soluble in alcohol and in
methylene chloride.
_ _
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Small cell carcinoma of the lung.
•
Acute monocytic and myelomonocytic leukaemia.
•
Hodgkin’s disease.
•
Non-Hodgkin’s lymphoma.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The usual dose of etoposide must be based on the clinical and
haematological response and
tolerance of the patient. A repeat course of etoposide should not be
administered until the
patient’s haematological function is within acceptable limits. (See
section 4.4 Special warnings
and precautions for use).
_ _
_ _
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_ADULT _
The dosage for Etoposide Injection is 50-60 mg/m
2
/day intravenously for 5 consecutive days
followed by a treatment free interval of 2-3 weeks. Total dose should
not usually exceed 400
mg/m
2
per course. In any case, repeat courses should not be given until the
hematological
parameters have been checked for evidence of myelosuppression and
found to be satisfactory.
METHOD OF ADMINISTRATION
Plastic devices made of acrylic or ABS (a polymer of acrylonitrile,
butadiene and styrene) have
been reported to crack or leak when used with undiluted Etoposide
injection.
Etoposide should only be given by slow intravenous infusion (see
section 4.4 Special warnings
and precautions for use, section 4.8 Adverse effects (undesirable
effects))
Etoposide should not be administered