DOXORUBICIN EBEWE VIALS 50 mg/25ml

Nazione: Giordania

Lingua: inglese

Fonte: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Principio attivo:

Doxorubicin Hcl 50 mg/25ml

Commercializzato da:

مستودع ادوية الصباغ - Sabbagh Drug Store

Codice ATC:

L01DB01

INN (Nome Internazionale):

Doxorubicin Hcl 50 mg/25ml

Dosaggio:

50 mg/25ml

Confezione:

1 Vial X 25ml

Prodotto da:

Fareva Unterach Gmbh/Austria (النمسا)

Foglio illustrativo

1
SUMMARY OF PRODUCT CHARACTERISTICS OF THE DRUG
1.
NAME OF DRUG
Doxorubicin Ebewe 2 mg/ml – vials
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for the preparation of an infusion solution contains
2 mg doxorubicin in the
form of doxorubicin hydrochloride.
Other ingredients with known effect: 1 ml contains 9 mg sodium
chloride.
For the full list of ingredients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for the production of an infusion solution.
Clear, red solution
pH value: 2.5 - 4
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Doxorubicin is used in adults, adolescents and children.

Mamma carcinoma

Neoadjuvant and adjuvant therapy of osteosarcoma

Advanced soft tissue sarcoma in adults

Small cell lung carcinoma (SCLC)

Hodgkin lymphoma

Highly malignant non-Hodgkin lymphoma

Induction and consolidation therapy for acute lymphatic leukaemia

Acute myeloblastic leukaemia

Advanced multiple myeloma

Advanced or recurring endometrium carcinoma

Advanced
or
recurring
papillary / follicular
thyroid carcinoma

Anaplastic thyroid carcinoma

Systemic
treatment
of
localised
advanced
or
metastasising
carcinoma of the bladder

Intravesical prophylaxis against a recurrence of superficial carcinoma
of the bladder
following transurethral resection

Recurring ovarian carcinoma

Wilms tumour (at stage II in highly malignant forms, all advanced
stages
[III–IV])

Advanced neuroblastoma

Ewing sarcoma
2
Doxorubicin is often administered in combination chemotherapy dosing
cycles in conjunction
with other cytostatics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Strictly for intravenous and intravesical application only.
The vial should be at room temperature before piercing it with a
needle.
Doxorubicin may only be administered under the supervision of a
qualified doctor experienced
in cytostatics therapies. Patients must also be carefully and
regularly monitored during
treatment.
Due to the risk of a fatal cardiomyopathy, the risks and advantag