Pfizer (Australia) VINCRISTINE SULFATE 5mg/5mL injection vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

vincristine sulfate, Quantity: 1 mg/mL

제공처:

Pfizer Australia Pty Ltd

약제 형태:

Injection, solution

구성:

Excipient Ingredients: mannitol; water for injections; sodium hydroxide; sulfuric acid

관리 경로:

Intravenous

패키지 단위:

5 x 5mL

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Vincristine is used primarily in the treatment of acute leukaemia, usually as a component of various chemotherapeutic regimens. It has also been used as part of combination therapy in the treatment of Hodgkin's disease, non-Hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, Wilm's tumour, osteogenic sarcoma, mycosis fungoides, Ewing's sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma of the lung and gynaecological tumours of childhood. Vincristine may be useful in patients with true idiopathic thrombocytopenic purpura resistant to the usual treatment, but not recommended as primary treatment for this disorder

제품 요약:

Visual Identification: Clear and colourless solution.; Container Type: Vial; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

승인 상태:

Registered

승인 날짜:

1994-06-22

제품 특성 요약

Version: pfpvinci10921
Supersedes: pfpvinci10321
Page 1 of 16
AUSTRALIAN
PRODUCT
INFORMATION
–
VINCRISTINE SULFATE INJECTION
1.
NAME OF THE MEDICINE
Vincristine sulfate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vincristine Sulfate Injection contains 1 mg/mL of vincristine sulfate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Vincristine Sulfate Injection is a sterile, hypertonic,
preservative-free solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vincristine is used primarily in the treatment of acute leukaemia,
usually as a component of
various chemotherapeutic regimens. It has also been used as part of
combination therapy in the
treatment of Hodgkin’s disease, non-Hodgkin’s malignant lymphomas,
rhabdomyosarcoma,
neuroblastoma, Wilm’s tumour, osteogenic sarcoma, mycosis fungoides,
Ewing’s sarcoma,
carcinoma of the uterine cervix, breast cancer, malignant melanoma,
oat-cell carcinoma of the
lung and gynaecological tumours of childhood.
Vincristine may be useful in patients with true idiopathic
thrombocytopenic purpura resistant
to the usual treatment, but is not recommended as primary treatment
for this disorder.
4.2 DOSE AND METHOD OF ADMINISTRATION
This preparation is for intravenous use only and is usually
administered at weekly intervals. It
can be fatal if administered intrathecally (see sections 4.3
Contraindications and 4.4 Special
warnings and precautions for use).
Vincristine should not be given intramuscularly, subcutaneously or
intrathecally. Intrathecal
use of vincristine usually results in death. When dispensed, flexible
plastic containers
containing this product should be labelled:
FOR INTRAVENOUS USE ONLY. FATAL IF
GIVEN BY ANY OTHER ROUTE.
Version: pfpvinci10921
Supersedes: pfpvinci10321
Page 2 of 16
DOSAGE
Neurotoxicity appears to be dose related. Extreme care must be used in
calculating and
administrating the dose of vincristine since overdosage may have very
serious or fatal outcome
(see section 4.9 O