ADRIAMYCIN SOLUTION FOR INJECTION 2 mgml

Ország: Szingapúr

Nyelv: angol

Forrás: HSA (Health Sciences Authority)

Aktív összetevők:

DOXORUBICIN HCl EQV DOXORUBICIN

Beszerezhető a:

PFIZER PRIVATE LIMITED

ATC-kód:

L01DB01

Adagolás:

2 mg/ml

Gyógyszerészeti forma:

INJECTION

Összetétel:

DOXORUBICIN HCl EQV DOXORUBICIN 2 mg/ml

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

Prescription Only

Gyártó:

Bridgewest Perth Pharma Pty Ltd

Engedélyezési státusz:

ACTIVE

Engedély dátuma:

1998-12-18

Betegtájékoztató

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

Termékjellemzők

PRODUCT
INFORMATION
–
ADRIAMYCIN
®
(DOXORUBICIN HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Doxorubicin hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADRIAMYCIN 10 mg/5 mL: Each 5 mL vial contains 10 mg doxorubicin
hydrochloride
(equivalent to 2 mg/mL of doxorubicin hydrochloride).
ADRIAMYCIN 50 mg/25 mL: Each 25 mL vial contains 50 mg doxorubicin
hydrochloride
(equivalent to 2 mg/mL of doxorubicin hydrochloride).
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
Brai
n
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Care
in
the
administration
of
ADRIAMYCIN
will
reduce
the
chance
of
peri