Mitomycin-C Kyowa 40 mg, powder for intravesical solution

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Mitomycin

Mevcut itibaren:

Kyowa Kirin Holdings B.V.

ATC kodu:

L01DC; L01DC03

INN (International Adı):

Mitomycin

Doz:

40 milligram(s)

Farmasötik formu:

Powder for solution for infusion

Terapötik alanı:

Other cytotoxic antibiotics; mitomycin

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2012-06-08

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MITOMYCIN-C KYOWA
® 40 MG POWDER FOR INTRAVESICAL SOLUTION
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mitomycin-C Kyowa 40 mg is and what it is used for
2.
What you need to know before you use Mitomycin-C Kyowa 40 mg
3.
How to use Mitomycin-C Kyowa 40 mg
4.
Possible side effects
5.
How to store Mitomycin-C Kyowa 40 mg
6.
Contents of the pack and other information
1.
WHAT MITOMYCIN-C KYOWA 40 MG IS AND WHAT IT IS USED FOR
Mitomycin-C Kyowa 40 mg is an anticancer medicine used for the
treatment of bladder cancer in adults.
This medicine is introduced directly into the bladder after surgery to
treat or reduce the chances of a
recurrence of the condition.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MITOMYCIN-C KYOWA 40 MG
DO NOT USE MITOMYCIN-C KYOWA 40 MG:
-
if you are allergic to Mitomycin C or any of the other ingredients of
this medicine (listed in
section 6).
‐
have certain types of blood disorders, e.g. if your bone marrow is not
making enough blood cells
(your doctor will check for this using blood tests), suffer from
problems with blood clotting or
bleeding, liver or kidney disorders, or have any active infections.
Please tell your doctor if you have
any of these problems and he will discuss with you whether this
medicine is appropriate for you.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Mitomycin-C
Kyowa 40 mg.
Treatment with Mitomycin-C Kyowa 40 mg will be administered to you
under the supervision of a
medical doctor who is experienced in cancer chemotherapy. The doctor
will therefore take all the
necessary precautions for the saf

Ürün özellikleri

Health Products Regulatory Authority
02 October 2019
CRN008VFL
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mitomycin-C Kyowa 40 mg, powder for intravesical solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 40 mg of Mitomycin-C.
Excipient(s) with known effect
Each vial also contains 378 mg of sodium (as sodium chloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for intravesical solution
Blue-purple powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mitomycin C must be used under supervision of an Oncologist.
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 40 mg 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In the treatment of superficial bladder tumours the usual dose is
20-40 mg dissolved in 20-40 ml of diluent, instilled into the
bladder through a urethral catheter, weekly or three times a week for
a total of 20 doses.
The dose should be retained by the patient for a minimum of one hour.
During this one hour period the patient should be
rotated every 15 minutes to ensur