CIPLA BLEOMYCIN 15K bleomycin sulfate 15000 IU powder for injection vial

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

bleomycin sulfate, Quantity: 15000 IU

Sẵn có từ:

Cipla Australia Pty Ltd

INN (Tên quốc tế):

bleomycin sulfate

Dạng dược phẩm:

Injection, powder for

Thành phần:

Excipient Ingredients: sodium hydroxide; hydrochloric acid

Tuyến hành chính:

Intraarterial, Intramuscular, Subcutaneous, Intravenous

Các đơn vị trong gói:

1x15000 IU VIAL, 10X15000 IU vials

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2015-03-19

Tờ rơi thông tin

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

Đặc tính sản phẩm

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