Endoxana Injection 1000 mg Powder for Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cyclophosphamide

Available from:

Baxter Holding B.V.

ATC code:

L01AA; L01AA01

INN (International Name):

Cyclophosphamide

Dosage:

1000 milligram(s)

Pharmaceutical form:

Powder for solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Nitrogen mustard analogues; cyclophosphamide

Authorization status:

Marketed

Authorization date:

2008-06-26

Patient Information leaflet

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.

Summary of Product characteristics

Health Products Regulatory Authority
21 December 2018
CRN008KG0
Page 1 of 23
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 20mg
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,
Health Products Regulatory Authority
21 December 2018
CRN008KG0
Page 2 of 23
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 - 300mg/m
2
daily as a single i.v. dose or daily divided oral doses.
300 -