ENDOXANA INJECTION

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

CYCLOPHOSPHAMIDE

Mevcut itibaren:

Baxter Healthcare Limited

ATC kodu:

L01AA01

INN (International Adı):

CYCLOPHOSPHAMIDE

Doz:

1000 Milligram

Farmasötik formu:

Pdr for Soln for Injection

Reçete türü:

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

Terapötik alanı:

cyclophosphamide

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

1990-08-10

Bilgilendirme broşürü

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. It includes other
important information on the use of ENDOXANA that might
be especially important for you.
In this leaflet:
1. What ENDO

Ürün özellikleri

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
intervals.
In combin