Mitomycin medac 40 mg powder and solvent for intravesical solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mitomycin

Available from:

medac Gesellschaft für klinische Spezialpräparate mbH

ATC code:

L01DC; L01DC03

INN (International Name):

Mitomycin

Dosage:

40 milligram(s)

Pharmaceutical form:

Powder and solvent for intravesical solution

Prescription type:

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

Therapeutic area:

Other cytotoxic antibiotics; mitomycin

Authorization status:

Marketed

Authorization date:

2016-04-08

Patient Information leaflet

pal (IE) Mitomycin medac 40 mg powder and solvent for intravesical
solution
National version: 01/2024
PACKAGE LEAFLET: INFORMATION FOR THE USER
MITOMYCIN MEDAC 40 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.
•
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 medac 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
(cytostatic). 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
Mitomycin medac is introduced into the urinary bladder (intravesical
application) to prevent
recurrence of superficial urinary bladder cancer after the tissue
affected by the cancer has been
removed 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 a p

Summary of Product characteristics

Health Products Regulatory Authority
26 February 2024
CRN00F2GW
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mitomycin medac 40 mg powder and solvent for intravesical solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Mitomycin medac contains 40 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 adults 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 only intended for intravesical use following
reconstitution.
Posology
The content of one vial is required for one bladder instillation.
There are many intravesical mitomycin regimens, varying in the dose of
mitomycin used, the frequency of instillation and the
duration of therapy.
Unless otherwise specified, the dose of mitomycin is 40 mg 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 regimen, frequency and
duration of therapy on an individual patient basis.
_Special populations_
_Elderly _
Insufficient data from clinical studies are available concerning the
use of mitomycin in patients ≥ 65 years of age.
_Renal or hepatic impairment_
The medicinal product should be used with caution in patients with
renal or hepatic impairment.
_Paediatric population_
The safety and efficacy of Mitomycin medac in children have not been
established.
No data are available.
Method of administration
Mitomycin medac is only intended for intravesical instillation after
being dissolved. It is advised to use this medicinal product at
its