Medicinal Products

DOXORUBICINE EBEWE 2 mg / ml solution for infusion bottle (with overwrap protection) of 100 ml

Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Doxorubicin
laboratory: Sandoz

Injection solution for IV infusion
All forms

Indication

- Breast cancers.
- Sarcomas of the bones and soft parts.
- Hodgkin's disease and non-Hodgkin's lymphoma.
- solid tumors of the child.
- lung cancer.
- Acute and chronic leukemias.
- Cancers of the bladder, ovary, stomach.

Dosage DOXORUBICINE EBEWE 2 mg / ml solution for infusion vial (with overwrap protection) 100 ml

- Breast cancers.
- Sarcomas of the bones and soft parts.
- Hodgkin's disease and non-Hodgkin's lymphoma.
- solid tumors of the child.
- lung cancer.
- Acute and chronic leukemias.
- Cancers of the bladder, ovary, stomach.

Against indications

CONTRAINDICATED:
This medicine is contraindicated in the following situations:
- pregnancy and breast feeding,
- cardiac toxicity induced by another anthracycline or maximum cumulative doses obtained for another anthracycline,
- combination with the yellow fever vaccine.
NOT RECOMMENDED :
This medicine is generally not recommended:
- in subjects with cardiac disease with proven heart failure. Coronary insufficiency is not a contraindication if it is controlled and is not complicated by a clear impairment of left ventricular function,
- in association with:
. live attenuated vaccines (except yellow fever),
. and phenytoin, fosphenytoin (see section on interactions).

Adverse effects Doxorubicin Ebewe

- General side effects:
. stomatitis,
. medullary hypoplasia in about 2/3 of patients,
. rapidly decreasing immunodepression,
. alopecia in 90% of the cases, but reversible at the end of the treatment,
. amenorrhea, azoospermia.
- Febrile attacks, nausea, vomiting, abdominal pain and diarrhea have also been reported. But these manifestations are transient and do not pose a serious therapeutic problem.
- Some modifications of the ECG may appear: rhythm disorders, lengthening of the QT space in particular; Acute rhythm disturbances can occur within hours of the injection. Frequent ECG checks, possibly supplemented by a 24-hour recording (Holter method) should help to clarify the meaning.
- Possible associated electrolyte disorders (hypokalemia, hyponatremia) must be corrected.
- In some cases, severe heart failure, which is resistant to usual treatments, may occur. These reactions are rare in patients who received a total dose less than 550 mg / m², they are more frequent beyond this dose and can in this case reach 27% of patients.
- As with other DNA-damaging anticancer agents, myelodysplastic syndromes and acute myeloid leukemias have been observed after combination therapy including doxorubicin.
- With the topoisomerase II inhibitors, there has been reported a higher than expected incidence of secondary leukemias presenting as de novo leukemias LAM2, LAM3, LAM4. Such forms may have a short latency period (from 1 to 3 years). These forms, accessible to a curative treatment, require early diagnosis and treatment adapted to curative purpose (see warnings and precautions for use).

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