Endoxana Injection 1000mg Powder for solution for Injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CYCLOPHOSPHAMIDE MONOHYDRATE

Available from:

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

ATC code:

L01AA01

INN (International Name):

CYCLOPHOSPHAMIDE MONOHYDRATE 1000 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

CYCLOPHOSPHAMIDE MONOHYDRATE 1000 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2005-12-29

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CYCLOPHOSPHAMIDE INJECTION 500 MG AND 1 G
CYCLOPHOSPHAMIDE MONOHYDRATE
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, Cyclophosphamide Injection will be called
Cyclophosphamide.
IMPORTANT THINGS TO KNOW ABOUT CYCLOPHOSPHAMIDE
Your doctor has prescribed Cyclophosphamide because you have cancer
that can be treated.
Cyclophosphamide 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
Cyclophosphamide 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.
Cyclophosphamide:

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
Cyclophosphamide or for at
least 6 months after treatment. You should use an effective
contraceptive. Ask your doctor
for adv

Summary of Product characteristics

- 1 -
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Endoxana Injection 1000 mg Powder for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cyclophosphamide monohydrate equivalent to 1000 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
interva