Mitomycin-C Kyowa 10mg powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mitomycin

Available from:

Kyowa Kirin Ltd

ATC code:

L01DC03

INN (International Name):

Mitomycin

Dosage:

10mg

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intraarterial; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010200; GTIN: 4987057160085

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MITOMYCIN-C KYOWA
® 2, 10, 20 OR 40 MG 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 you get any of the side effects, talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
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
As a single medicine or in a combination with other medicines,
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 given by injection or,
alternatively introduced
directly into the bladder after surgery to reduce the chances of a
recurrence of the condition

Breast cancer and cancer of the neck of the womb (the cervix).

It shows some activity in cancers of the stomach, pancreas, lung,
liver, head and neck, prostate,
leukaemia (a disease of the blood) and certain other types of tumours.

It has a possible role with other anti-cancer medicines in cancer of
the lower bowel, skin cancer
and sarcomas (cancers of a particular kind of body tissue called
connective tissue).

It has been successfully used in combination with surgery, before
operations (in cases of cancer
of the upper digestive tract) and after operations (in cases of cancer
of the stomach).

It has been shown to be effective when used in combination with
ra

Summary of Product characteristics

OBJECT 1
MITOMYCIN-C KYOWA
Summary of Product Characteristics Updated 11-Dec-2017 | Kyowa Kirin
Ltd
1. Name of the medicinal product
Mitomycin-C Kyowa, 2 mg, powder for solution for injection.
Mitomycin-C Kyowa, 10 mg, powder for solution for injection.
Mitomycin-C Kyowa, 20 mg, powder for solution for injection.
Mitomycin-C Kyowa, 40 mg, powder for solution for injection.
2. Qualitative and quantitative composition
Mitomycin C 2, 10, 20 or 40 mg
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Powder for solution for injection.
Blue-purple powder.
4. Clinical particulars
4.1 Therapeutic indications
ANTIMITOTIC AND CYTOTOXIC
Recommended for certain types of cancer in combination with other
drugs or after primary therapy has
failed. It has been successfully used to improve subjective and
objective symptoms in a wide range of
neoplastic conditions.
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 can reduce recurrence rates in
newly diagnosed patients with
superficial bladder cancer.
2. As a single agent and in combination with other drugs in metastatic
breast cancer.
3. In combination with other agents in advanced squamous cell
carcinoma of the uterine cervix.
4. It shows a degree of activity as part of combination therapy in
carcinoma of the stomach, pancreas and
lung (particularly non-small cell).
5. It shows a degree of activity as a single agent and in combination
in liver cancer when given by the
intra-arterial route.
6. It has a possible role in combination with other cytotoxic drugs in
colo-rectal cancer.
7. It shows a degree of activity as a single agent or part of
combination therapy in cancer of the head and
neck.
8. It shows a degree of activity as a single agent in cancer of the
prostate.
9. It has a possible role in skin cancer.
10. It has a degree of activity in leukaemia and non-solid tumours.
11. It has a possible role in sarcomas.
12. It has been successfully used in combinati