Mitomycin medac 20 mg powder and solvent for intravesical solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mitomycin

Available from:

Medac Gesellschaft fur Klinische Spezialpraparate mbH

ATC code:

L01DC; L01DC03

INN (International Name):

Mitomycin

Dosage:

20 milligram(s)

Pharmaceutical form:

Pdr+Solv/Soln/Intravesical Use

Prescription type:

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

Therapeutic area:

Other cytotoxic antibiotics; mitomycin

Authorization status:

Not marketed

Authorization date:

2016-04-08

Patient Information leaflet

Package leafl et: Information for the user
Mitomycin medac 20 mg
powder and solvent for intravesical solution
Mitomycin
Read all of this leaflet carefully before
you start using 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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Mitomycin medac is and what
it is used for
2. What you need to know before you
use Mitomycin medac
3. How to use Mitomycin medac
4. Possible side effects
5. How to store Mitomycin medac
6. Contents of the pack and other
information
1.
What Mitomycin medac is and what
it is used for
Mitomycin is a medicine for the treatment
of cancer, i.e. a medicine which prevents
or considerably delays the division of
active cells by influencing their metabolism
in various ways. The therapeutic use of
cytostatics in cancer therapy is based on
the fact that one way in which cancer cells
differ from normal cells in the body is that
the rate of cell division is increased due to
a lack of control of their growth.
Therapeutic indications
Application in the urinary bladder
(intravesical application) for the prevention
of a relapse in the case of superficial urinary
bladder cancer after removal of tissue
through the urethra (transurethral resection).
2.
What you need to know before you
use Mitomycin medac
Mitomycin may only be administered
if strictly indicated, and by doctors
experienced in this type of therapy.
Do not use Mitomycin medac
•
if you are allergic to mitomycin or any
of the other ingredients of this medicine
(listed in section 6),
•
while breast-feeding: you must not
breast-feed during treatment with
mitomycin,
•
if you have

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mitomycin medac 20 mg powder and solvent for intravesical solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Mitomycin medac, contains 20 mg mitomycin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for intravesical solution
Powder: Grey to grey blue powder or cake.
Solvent: Clear and colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mitomycin medac is indicated as INTRAVESICAL administration for
relapse prevention in adult patients with superficial
urinary bladder carcinoma after transurethral resection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Mitomycin medac must be administered by physicians experienced in this
therapy, only if strictly indicated.
Mitomycin medac is intended for intravesical use following
reconstitution.
Posology
There are many intravesical mitomycin regimens, varying in dose of
mitomycin used, the frequency of instillation and
the duration of therapy.
Unless otherwise specified, the dosage of mitomycin is 20
-
40 mg mitomycin instilled into the bladder once weekly.
Regimens with instillations every 2 weeks, every month or 3 monthly
can also be used.
The specialist should decide on the optimum regime, frequency and
duration of therapy on an individual patient basis.
The urine pH should be higher than pH 6.
_Special populations_
The dose must be reduced in patients who have undergone extensive
previous cytostatic therapy, in case of
myelosuppression or in elderly patients.
Insufficient data from clinical studies are available concerning the
use of mitomycin in patients
65 years of age.
The product should not be used in patients with renal impairment (see
section 4.3)
The product is not recommended in patients with hepatic impairment due
to lack of efficacy and safety data in this
group of patients.
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