ADRIAMYCIN CS INJECTION 2 mgml

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

DOXORUBICIN HCl EQV DOXORUBICIN

متاح من:

PFIZER PRIVATE LIMITED

ATC رمز:

L01DB01

جرعة:

2 mg/ml

الشكل الصيدلاني:

INJECTION

تركيب:

DOXORUBICIN HCl EQV DOXORUBICIN 2 mg/ml

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

Bridgewest Perth Pharma Pty Ltd

الوضع إذن:

ACTIVE

تاريخ الترخيص:

1998-12-18

نشرة المعلومات

PRODUCT INFORMATION – ADRIAMYCIN
® CS
(DOXORUBICIN HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Doxorubicin hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADRIAMYCIN Injection is available in vials containing the active
ingredient doxorubicin
hydrochloride 10 mg/5 mL and 50 mg/25 mL.
Doxorubicin hydrochloride is an orange-red, crystalline, hygroscopic
powder that is soluble
in water and slightly soluble in methanol.
Doxorubicin is a cytotoxic anthracycline antibiotic isolated from
cultures of
_Streptomyces _
_peucetius var. caesius._
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
ADRIAMYCIN Injection is a red coloured, clear solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADRIAMYCIN has been used successfully to produce regression in
neoplastic conditions
such as: acute leukaemia, Wilms’ tumour, neuroblastoma, soft tissue
and bone sarcomas,
breast carcinoma, lymphomas of both Hodgkin’s and non-Hodgkin’s
type, bronchogenic
(lung)
carcinoma,
thyroid
carcinoma,
hepatomas,
ovarian
carcinoma,
etc.
The
main
antitumour activities are listed in Table 1. ADRIAMYCIN is also
indicated by intravesical
administration in the primary management of non-metastatic carcinoma
of the bladder (Tis,
T
1
, T
2
).
TABLE 1: ADRIAMYCIN ANTITUMOUR ACTIVITY
TUMOUR TYPE
RESPONSE
RATE (%)
MEDIAN
DURATION
(MONTH)
FIRST LINE
CHEMOTHERAPY
Established
Activity
Breast
Ovary
Lung
35
38
30
3-6
3-6
3
√
?
?
Sarcoma
Wilms’
Bladder
Neuroblastoma
Hodgkin’s
Non-Hodgkin’s Lymphoma
Acute Leukaemia
Hepatoma
Thyroid
30
66
28
41
36
40
35
32
30
4
4
4-6
4
4-6
4-6
3
4-6
6-10
√
√
?
√
?
√
?
√
√
Some Response
Stomach
Cervix
Head & Neck
Testicle
Myeloma
Endometrial
30
32
19
20
33
36
2-4
2-6
2-4
3-6
3
4-6
√?
?
√?
Unresponsive
Colorectal
Pancreas
Renal
Melanoma
Brain
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Care
in
the
administration
of
ADRIAMYCIN
will
reduce
the
chance
of
perivenous
infiltration.
It
may
also
decrease
the
chance
of
local
reaction

خصائص المنتج

PRODUCT INFORMATION – ADRIAMYCIN
® CS
(DOXORUBICIN HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Doxorubicin hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADRIAMYCIN is available in vials containing 10 mg/5 mL and 50 mg/25 mL
of doxorubicin
hydrochloride.
Doxorubicin hydrochloride is an orange-red, crystalline, hygroscopic
powder that is soluble in
water and slightly soluble in methanol.
Doxorubicin is a cytotoxic anthracycline antibiotic isolated from
cultures of
_Streptomyces _
_peucetius var. caesius._
EXCIPIENT(S) WITH KNOWN EFFECT
Each vial contains 9 mg/mL of sodium chloride.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
ADRIAMYCIN is a red coloured, clear solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADRIAMYCIN has been used successfully to produce regression in
neoplastic conditions such
as: acute leukaemia, Wilms’ tumour, neuroblastoma, soft tissue and
bone sarcomas, breast
carcinoma, lymphomas of both Hodgkin’s and non-Hodgkin’s type,
bronchogenic (lung)
carcinoma, thyroid carcinoma, hepatomas, ovarian carcinoma, etc. The
main antitumour
activities are listed in Table 1. ADRIAMYCIN is also indicated by
intravesical administration
in the primary management of non-metastatic carcinoma of the bladder
(Tis, T
1
, T
2
).
TABLE 1: ADRIAMYCIN ANTITUMOUR ACTIVITY
TUMOUR TYPE
RESPONSE
RATE (%)
MEDIAN
DURATION
(MONTH)
FIRST LINE
CHEMOTHERAPY
Established
Activity
Breast
Ovary
Lung
Sarcoma
Wilms’
Bladder
Neuroblastoma
Hodgkin’s
Non-Hodgkin’s Lymphoma
Acute Leukaemia
Hepatoma
Thyroid
35
38
30
30
66
28
41
36
40
35
32
30
3-6
3-6
3
4
4
4-6
4
4-6
4-6
3
4-6
6-10
√
?
?
√
√
?
√
?
√
?
√
√
Some Response
Stomach
Cervix
Head & Neck
Testicle
Myeloma
Endometrial
30
32
19
20
33
36
2-4
2-6
2-4
3-6
3
4-6
√?
?
√?
Unresponsive
Colorectal
Pancreas
Renal
Melanoma
Brain
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Care in the administration of ADRIAMYCIN will reduce the chance of
perivenous infiltration.
It may als