Dacarbazine Medak powder for solution for injection and infusion 200 mg vial No. 10

Powder for preparation of solution for injection or infusion Dacarbazine-Medak is indicated in the treatment of malignant metastatic melanoma.

As part of combination chemotherapy:

Composition

Active ingredient: dacarbazine;

1 vial contains dacarbazine citrate equivalent to dacarbazine 200 mg.

Excipients: citric acid, allspice (E 421).

Contraindication

Method of application

Administer intravenously. Therapy should be administered by a physician experienced in oncology and hematology.

Dacarbazine is sensitive to sunlight. All dacarbazine solutions should be protected from light, including during administration (light-resistant infusion set).

The injection should be carried out very carefully, avoiding the ingress of dacarbazine solution into the tissues, as this may cause tissue damage and pain at the injection site. If extravasation occurs, the injection should be stopped immediately and the remainder of the dose should be administered into another vein.

Application features

Pregnant women

Contraindicated.

Children

Not recommended for use.

Drivers

Dacarbazine may affect the ability to drive or operate machinery due to central nervous system side effects, nausea and vomiting.

Overdose

The first expected complications of dacarbazine overdose are bone marrow suppression, finally bone marrow aplasia, occurring after 2 weeks. A decrease in leukocyte and platelet counts may be observed by week 4. Even if overdose is only suspected, long-term monitoring of the patient's blood counts is necessary.

Overdose with dacarbazine should not be allowed. There is no known specific antidote.

Side effects

Interaction

In case of previous or concomitant treatment with drugs that have an adverse effect on the bone marrow (cytostatic agents, radiotherapy), the myelotoxicity of dacarbazine may be increased.

Metabolism studies have not been conducted, but it is known that hydroxylation of the parent compound enhances its antitumor activity. Dacarbazine is metabolized in the liver by P450 (CYP1A1, CYP1A2 and CYP2E1). This should be considered when co-administering drugs that are metabolized by these same enzymes.

Dacarbazine may enhance the photosensitizing effect of methoxypsoralen.

Storage conditions

Store at a temperature not exceeding 25 °C, out of the reach of children, in the original packaging to protect from light.

Shelf life - 3 years.