Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Mitomycin
Kyowa Kirin Holdings B.V.
L01DC; L01DC03
Mitomycin
40 milligram(s)
Powder for solution for infusion
Other cytotoxic antibiotics; mitomycin
Marketed
2012-06-08
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 Olvassa el a teljes dokumentumot
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 Olvassa el a teljes dokumentumot