Mitomycin-C Kyowa 10 mg, Powder for Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mitomycin

Available from:

Kyowa Kirin Limited

ATC code:

L01DC; L01DC03

INN (International Name):

Mitomycin

Dosage:

10 milligram(s)

Pharmaceutical form:

Powder for solution for injection

Prescription type:

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

Therapeutic area:

Other cytotoxic antibiotics; mitomycin

Authorization status:

Marketed

Authorization date:

2003-12-12

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
MITOMYCIN-C KYOWA
® 10MG / MITOMYCIN-C
KYOWA
® 40MG
POWDER FOR SOLUTION FOR INJECTION
(Mitomycin-C)
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. Do not pass it on to
others. It may harm them, even if their symptoms are the
same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell 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-C Kyowa is and what it is used for
2.
What you need to know before you use Mitomycin-C Kyowa
3.
How to use Mitomycin-C Kyowa
4.
Possible side effects
5.
How to store Mitomycin-C Kyowa
6.
Contents of the pack and other information
1.
WHAT MITOMYCIN-C KYOWA IS AND WHAT IT IS USED FOR
Mitomycin-C Kyowa can be used to treat different types of cancers in
many different parts of the body as described below:
•
In bladder cancer Mitomycin-C Kyowa can be administered by injection
or, alternatively by instillation directly into the
bladder after surgery to reduce the chances of a recurrence of the
condition.
•
In certain types of cancer of the stomach, pancreas, oesophagus, lower
bowel, biliary tract and lung Mitomycin-C Kyowa
can be used in combination with other drug treatments.
•
In a type of cancer of the anus, Mitomycin-C Kyowa can be used in
combination with other drug treatments or with
radiotherapy.
•
In a certain type of breast cancer, Mitomycin-C Kyowa can be used as a
single agent or in combination with other drug
treatments.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MITOMYCIN-C KYOWA
DO NOT USE MITOMYCIN-C KYOWA IF YOU:
•
are allergic (hypersensitive) to mitomycin or any of the other
ingredients of Mitomycin-C Kyowa (listed in section 6

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mitomycin-C Kyowa 10 mg, Powder for Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 10 mg of Mitomycin-C.
Each vial also contains 240mg of sodium chloride (equivalent to 4.1
mmol sodium).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection (powder for injection)
Blue/purple powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mitomycin C must be used under supervision of an Oncologist.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Paediatric population
The safety and efficacy of Mitomycin C in children has not yet been
established. No data are available.
For parenteral use.
Intravenously, the dose should be given with great care in order to
avoid extravasation.
1.
As a single agent in the treatment of superficial bladder cancer. In
addition it has been shown that post-operative
instillations of Mitomycin-C Kyowa can reduce recurrence rates in
newly diagnosed patients with superficial bladder
cancer.
2.
As a single agent or as part of combination therapy in the treatment
of adenocarcinoma of the breast.
3.
As part of combination therapy in the treatment of adenocarcinomas of
the stomach and oesophagus.
4.
Small studies have suggested it may be useful as part of combination
therapy in the treatment of adenocarcinomas of
the pancreas and biliary tract.
5.
As part of combination therapy with other cytotoxic drugs and
radiotherapy in the treatment of squamous cell
carcinoma of the anus.
6.
Small studies have suggested that it may be useful as part of
combination therapy in the treatment of non small cell
lung cancer.
7.
Limited studies suggest it may be useful as part of combination
therapy in the treatment of adenocarcinoma of the
colon and rectum.
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