Doxorubicin EBEWE

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

doxorubicin (doxorubicin hydrochloride)

Available from:

EBEWE Pharma Ges. m.b.H. Nfg. KG

INN (International Name):

doxorubicin (doxorubicin hydrochloride)

Dosage:

2mg/ml

Pharmaceutical form:

concentrate for solution for infusion

Prescription type:

Prescription

Patient Information leaflet

Doxorubicin Ebewe®- Concentrate for Solution for Infusion CIS
- Prescribing Information (Package Leaflet)
Doxorubicin Ebewe_leaflet.doc
Page 1 of 18
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Doxorubicin Ebewe®
concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 5 ml solution contains 10 mg of doxorubicin
hydrochloride (2 mg/ml).
One vial with 25 ml solution contains 50 mg of doxorubicin
hydrochloride (2 mg/ml).
Other excipients with known effect: 1 ml contains 9 mg of sodium
chloride.
For a complete list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear red solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Therapeutic indications foradults, adolescents and children:

breast cancer

neoadjuvant and adjuvant therapy of osteosarcoma

advanced soft tissue sarcoma in adults

small cell lung cancer (SCLC)

Hodgkin’s lymphoma.

highly malignant non-Hodgkin’s lymphoma

Induction and consolidation therapy in acute lymphatic leukaemia

acute myeloblastic leukaemia

advanced multiple myeloma

advanced or recurrent papillary endometrial carcinoma

advanced or recurrent papillary/follicular thyroid carcinoma

anaplastic thyroid carcinoma

systemic treatment of local advanced or metastasised bladder carcinoma

intravesical prophylaxis of recurrences of surface bladder carcinoma
after transurethral
resection

recurring ovarian cancer

Wilms’ tumour

advanced neuroblastoma

Ewing’s sarcoma
Doxorubicin is often used in combined chemotherapy dosing regimens
with other cytostatic
agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
For intravenous and intravesical administration only.
The ampoule should be heated to room temperature before puncturing it
with a needle.
Doxorubicin must only be administered under the supervision of a
qualified physician
experienced in treatment with cytostatic agents. Furthermore, the
patient must be carefully
and frequent

Summary of Product characteristics

Doxorubicin Ebewe®- Concentrate for Solution for Infusion CIS
- Prescribing Information (Package Leaflet)
Doxorubicin Ebewe_SmPC.doc
Page 1 of 18
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Doxorubicin Ebewe®
concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 5 ml solution contains 10 mg of doxorubicin
hydrochloride (2 mg/ml).
One vial with 25 ml solution contains 50 mg of doxorubicin
hydrochloride (2 mg/ml).
Other excipients with known effect: 1 ml contains 9 mg of sodium
chloride.
For a complete list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear red solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Therapeutic indications foradults, adolescents and children:

breast cancer

neoadjuvant and adjuvant therapy of osteosarcoma

advanced soft tissue sarcoma in adults

small cell lung cancer (SCLC)

Hodgkin’s lymphoma.

highly malignant non-Hodgkin’s lymphoma

Induction and consolidation therapy in acute lymphatic leukaemia

acute myeloblastic leukaemia

advanced multiple myeloma

advanced or recurrent papillary endometrial carcinoma

advanced or recurrent papillary/follicular thyroid carcinoma

anaplastic thyroid carcinoma

systemic treatment of local advanced or metastasised bladder carcinoma

intravesical prophylaxis of recurrences of surface bladder carcinoma
after transurethral
resection

recurring ovarian cancer

Wilms’ tumour

advanced neuroblastoma

Ewing’s sarcoma
Doxorubicin is often used in combined chemotherapy dosing regimens
with other cytostatic
agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
For intravenous and intravesical administration only.
The ampoule should be heated to room temperature before puncturing it
with a needle.
Doxorubicin must only be administered under the supervision of a
qualified physician
experienced in treatment with cytostatic agents. Furthermore, the
patient must be carefully
and frequently