Medicinal Products

DOXORUBICINE ASTA MEDICA 50 mg

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

Lyophilisate for parenteral use
Box of 1 vial of 50 mg
All forms

Indication

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

Dosage DOXORUBICINE ASTA MEDICA 50 mg Lyophilisate for parenteral use Box of 1 vial of 50 mg

Dosage:
The average dosage is 40 to 75 mg / m² per cycle.
Each cycle is separated from the previous one by an interval of 3 to 4 weeks. The cycles are repeated up to a maximum total dose of 550 mg / m².
Administration mode :
After introducing the solvent into the bottle containing doxorubicin, it is essential to shake the bottle until a perfectly clear solution is obtained.
The dose of doxorubicin is administered at least 3 to 5 minutes into the tubing of a venous infusion of isotonic sodium chloride solution or 5% glucose solution:
- in one go,
- in 2 times during the day,
- be spread over 2 or 3 days.
It is not necessary to perform a long infusion, which can be installed shortly before the administration of doxorubicin and stopped a few minutes later.
It is extremely important to ensure that the administration is well endovenous.
Extravasation may cause necrosis of the surrounding tissues: in this case, the injection should be discontinued immediately.

Against indications

CONTRAINDICATED:
- Pregnancy.
- Breastfeeding.
- Association with the anti-amarile vaccine, phenytoin for prophylactic purposes.
NOT RECOMMENDED :
Subject with cardiopathy with myocardial insufficiency.
- Association with other live attenuated vaccines.

Adverse effects Doxorubicin Asta Medica

- stomatitis,
- medullary hypoplasia in about two-thirds of subjects,
- immunodepression, rapidly regressive,
- 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 make it possible to specify their meaning.
Potential associated electrolyte disturbances (hypokalemia, hyponatremia) should be corrected. In some cases, severe heart failure, which is resistant to usual treatment, may occur. These reactions are rare in patients who received a total dose of less than 550 mg / m², they are more frequent beyond this dose and can in this case reach 27% of patients.
- As with other cancer-modifying anticancer agents, myelodysplastic syndromes and
Acute myeloid leukemias have been observed after combination therapy including doxorubicin.
- With topoisomerase II inhibitors, there has been reported a higher than expected incidence of
secondary leukaemias presenting as de novo leukemias LAM2, LAM3, LAM4. Such
forms may have a short latency period (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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