দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
bleomycin sulfate, Quantity: 15000 IU
Cipla Australia Pty Ltd
bleomycin sulfate
Injection, powder for
Excipient Ingredients: sodium hydroxide; hydrochloric acid
Intraarterial, Intramuscular, Subcutaneous, Intravenous
1x15000 IU VIAL, 10X15000 IU vials
(S4) Prescription Only Medicine
Palliation and treatment adjuvant to surgery and radiation therapy of the following neoplasms: Squamous cell carcinoma of the skin, head and neck, and oesophagus (primary indication). Squamous cell carcinoma of the larynx, penis and uterine cervix. Squamous cell carcinoma of the bronchus (response infrequent). Choriocarcinoma and embryonal cell carcinoma of the testis. Advanced Hodgkin's disease and other lymphomas. Mycosis fungoides Note. Use of bleomycin after radiation therapy is less successful than use before radiation therapy. Bleomycin is bone marrow sparing and may be used when other cytotoxic agents are contraindicated.
Visual Identification: A sterile freeze dried powder for reconstitution. White to off white crystalline powder, very hygroscopic.Clear, colourless solution on reconstitution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2015-03-19
CIPLA BLEOMYCIN 15K 1 CIPLA BLEOMYCIN 15K CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING CIPLA BLEOMYCIN 15K? CIPLA BLEOMYCIN 15K contains the active ingredient bleomycin. CIPLA BLEOMYCIN 15K is used to interfere with the growth of cancer cells, which are eventually destroyed For more information, see Section 1. Why am I using CIPLA BLEOMYCIN 15K? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CIPLA BLEOMYCIN 15K? Do not use if you have ever had an allergic reaction to CIPLA BLEOMYCIN 15K or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use CIPLA BLEOMYCIN 15K? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CIPLA BLEOMYCIN 15K and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE CIPLA BLEOMYCIN 15K? • Your doctor will decide what dose of CIPLA BLEOMYCIN 15K you will receive. This depends on your condition and other factors, such as your weight and height, kidney function and other chemotherapy medicines you are being given. • CIPLA BLEOMYCIN 15K may be given alone or in combination with other drugs. More instructions can be found in Section 4. How do I use CIPLA BLEOMYCIN 15K? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CIPLA BLEOMYCIN 15K? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist or nurse you visit that you are using CIPLA BLEOMYCIN 15K. • If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are being given CIPLA BLEOMYCIN 15K. THINGS YOU SHOULD NOT DO • Be careful not to cut yourself when you are using sharp objects such as a razo সম্পূর্ণ নথি পড়ুন
AUSTRALIAN PRODUCT INFORMATION - CIPLA BLEOMYCIN 15K (BLEOMYCIN SULFATE) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Cipla Bleomycin 15K powder for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bleomycin Sulfate Powder for Injection contains bleomycin sulfate 15,000 IU per vial. Each vial contains 55 to 70% of bleomycin A2 and 25 to 32% of bleomycin B2 For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM White to off white crystalline powder, very hygroscopic. Clear, colourless solution on reconstitution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bleomycin is indicated for palliation and treatment adjuvant to surgery and radiation therapy of the following neoplasms: • Squamous cell carcinoma of the skin, head and neck, and oesophagus (primary indication). • Squamous cell carcinoma of the larynx, penis and uterine cervix. • Squamous cell carcinoma of the bronchus (response infrequent). • Choriocarcinoma and embryonal cell carcinoma of the testis. • Advanced Hodgkin's disease and other lymphomas. • Mycosis fungoides. Note:. _ _ Use of bleomycin after radiation therapy is less successful than use before radiation therapy. Bleomycin is bone marrow sparing and may be used when other cytotoxic agents are contraindicated. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Initial treatment (Intramuscular, intravenous or subcutaneous administration). Total doses of over 300,000 IU should be given with great caution. 10,000 to 20,000 IU/m 2 of body surface area given weekly or twice weekly. Alternatively, give 15,000 IU daily for 7 days followed by three weeks off treatment and repeat twice so that a total dose of approximately 300,000 IU is administered. Improvement of lymphomas and testicular tumours is prompt, i.e. within two weeks while response by squamous cell cancers may take as long as three weeks. A therapeutic response should be observed as the total dose approaches 150,000 IU, if this is not seen, consideration should be given to other therapy. Note: W সম্পূর্ণ নথি পড়ুন