Endoxana Injection 500mg Powder for solution for Injection

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

CYCLOPHOSPHAMIDE MONOHYDRATE

제공처:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC 코드:

L01AA01

INN (International Name):

CYCLOPHOSPHAMIDE MONOHYDRATE 500 mg

약제 형태:

POWDER FOR SOLUTION FOR INJECTION

구성:

CYCLOPHOSPHAMIDE MONOHYDRATE 500 mg

처방전 유형:

POM

치료 영역:

ANTINEOPLASTIC AGENTS

승인 상태:

Authorised

승인 날짜:

2005-12-29

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENDOXANA INJECTION 500 MG AND 1000 MG
POWDER FOR SOLUTION FOR INJECTION
CYCLOPHOSPHAMIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
Throughout this leaflet, ENDOXANA Injection will be called ENDOXANA.
IMPORTANT THINGS TO KNOW ABOUT ENDOXANA
Your doctor has prescribed ENDOXANA because you have cancer that can
be treated.
ENDOXANA is a medicine that kills cancer cells but, as a result, also
attacks normal cells.
It can therefore have a number of side effects. Your doctor will not
give you ENDOXANA
unless he or she thinks that your cancer is more of a risk to you than
any possible side
effects. Your doctor will check you regularly and treat any side
effects where possible.
ENDOXANA:
•
will reduce your blood cell count, which may make you feel tired and
be more likely to
get infections.
•
can affect your kidneys and bladder. You may be given another medicine
called Mesna
to help prevent any damage. If you notice blood in your urine, tell
your doctor
immediately.
•
like most anti-cancer or chemotherapy medicines, you may lose your
hair (anything
from thinning to total loss), although it should start to grow back
once your treatment
has finished. It may also make you feel sick or be sick. Your doctor
can give you
advice or medicines to help.
•
men or women should not have a child during treatment with ENDOXANA or
for at least
6 to 12 months after treatment. You should use an effective
contraceptive. Ask your
doctor for advice.
NOW READ THE REST OF THIS LEAFLET.

제품 특성 요약

- 1 -
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Endoxana Injection 500 mg Powder for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cyclophosphamide monohydrate equivalent to 500 mg
anhydrous
cyclophosphamide.
When reconstituted as directed, the solution contains 20 mg
cyclophosphamide per ml.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
A white crystalline powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Endoxana is a cytotoxic drug for the treatment of malignant disease in
adults. As a single
agent, it has successfully produced an objective remission in a wide
range of malignant
conditions. Endoxana is also frequently used in combination with other
cytotoxic drugs,
radiotherapy or surgery.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Endoxana Injection is for intravenous administration.
Endoxana should only be used by clinicians experienced in the use of
cancer chemotherapy.
Endoxana should only be administered where there are facilities for
regular monitoring of
clinical, biochemical and haematological parameters before, during,
and after administration
and under the direction of a specialist oncology service.
_Posology _
Dosage must be individualized. Doses and duration of treatment and/or
treatment intervals
depend on the therapeutic indication, the scheme of a combination
therapy, the patient’s
general state of health and organ function, and the results of
laboratory monitoring (in
particular, blood cell monitoring).
A guide to the dosage regimens used for most indications is given
below.
This treatment should be continued until a clear remission or
improvement is seen or be
interrupted when the extent of leucopenia becomes unacceptable.
Conventional dose:
80 - 300 mg/m
2
daily as a single i.v. dose or daily divided oral doses.
300 - 600 mg/m
2
as a single i.v. dose weekly.
High dose:
600 - 1500 mg/m
2
as a single i.v. dose or short infusion given at 10 - 20 day
intervals