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āĻāĻžāĻˇāĻž: āĻāĻāĻ°ā§āĻāĻŋ
āĻ¸ā§āĻ¤ā§āĻ°: JFDA (Jordan Food & Drug Administration - اŲŲ ؤØŗØŗØŠ اŲؚاŲ ØŠ ŲŲØēØ°Ø§ØĄ ŲاŲدŲØ§ØĄ)
Doxorubicin Hcl 50 mg/25ml
Ų ØŗØĒŲدؚ ادŲŲØŠ اŲØĩباØē - Sabbagh Drug Store
L01DB01
Doxorubicin Hcl 50 mg/25ml
50 mg/25ml
1 Vial X 25ml
Fareva Unterach Gmbh/Austria (اŲŲŲ Øŗا)
1 SUMMARY OF PRODUCT CHARACTERISTICS OF THE DRUG 1. NAME OF DRUG Doxorubicin Ebewe 2 mg/ml â 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. īˇ Mamma carcinoma īˇ Neoadjuvant and adjuvant therapy of osteosarcoma īˇ Advanced soft tissue sarcoma in adults īˇ Small cell lung carcinoma (SCLC) īˇ Hodgkin lymphoma īˇ Highly malignant non-Hodgkin lymphoma īˇ Induction and consolidation therapy for acute lymphatic leukaemia īˇ Acute myeloblastic leukaemia īˇ Advanced multiple myeloma īˇ Advanced or recurring endometrium carcinoma īˇ Advanced or recurring papillary / follicular thyroid carcinoma īˇ Anaplastic thyroid carcinoma īˇ Systemic treatment of localised advanced or metastasising carcinoma of the bladder īˇ Intravesical prophylaxis against a recurrence of superficial carcinoma of the bladder following transurethral resection īˇ Recurring ovarian carcinoma īˇ Wilms tumour (at stage II in highly malignant forms, all advanced stages [IIIâIV]) īˇ Advanced neuroblastoma īˇ 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 āĻ¸āĻŽā§āĻĒā§āĻ°ā§āĻŖ āĻ¨āĻĨāĻŋ āĻĒāĻĄāĻŧā§āĻ¨