Country: Сингапур
Језик: Енглески
Извор: HSA (Health Sciences Authority)
DOXORUBICIN HCl EQV DOXORUBICIN
PFIZER PRIVATE LIMITED
L01DB01
2 mg/ml
INJECTION
DOXORUBICIN HCl EQV DOXORUBICIN 2 mg/ml
INTRAVENOUS
Prescription Only
Bridgewest Perth Pharma Pty Ltd
ACTIVE
1998-12-18
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 Прочитајте комплетан документ
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 Прочитајте комплетан документ