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SPC, UK: DACARBAZINE Powder for solution for injection or infusion (2017)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
medac GmbH
Διεύθυνση :
Fehlandtstrasse 3, 20354 Hamburg, Germany
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Περιεχόμενα

Name of the medicinal product

Dacarbazine medac 100 mg, powder for solution for injection/infusion. Dacarbazine medac 200 mg, powder for solution for injection/infusion. Dacarbazine medac 500 mg, powder for solution for infusion. ...

Qualitative and quantitative composition

Each single-dose vial of Dacarbazine medac 100 mg contains 100 mg dacarbazine (as dacarbazine citrate, formed in situ). After reconstitution Dacarbazine medac 100 mg contains 10 mg/ml dacarbazine. Each ...

Pharmaceutical form

Dacarbazine medac 100 mg (200 mg): Powder for solution for injection/infusion. Dacarbazine medac 500 mg (1000 mg): Powder for solution for infusion. Dacarbazine medac is a white or pale yellow powder. ...

Therapeutic indications

Dacarbazine is indicated for the treatment of patients with metastasised malignant melanoma. Further indications for dacarbazine as part of a combination chemotherapy are: advanced Hodgkins disease, advanced ...

Posology and method of administration

Posology The use of dacarbazine should be confined to physicians experienced in oncology or haematology. Dacarbazine is sensitive to light exposure. All reconstituted solutions should be suitably protected ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, pregnancy or breastfeeding (see section 4.6), leukopenia and/or thrombocytopenia, severe liver or kidney diseases. ...

Special warnings and precautions for use

It is recommended that dacarbazine should only be administered under the supervision of a physician specialised in oncology who has the facilities for regular monitoring of clinical, biochemical and haematological ...

Interaction with other medicinal products and other forms of interaction

In case of previous or concomitant treatment having adverse effects on the bone marrow (particularly cytostatic agents, irradiation) myelotoxic interactions are possible. Studies to investigate the presence ...

Pregnancy and lactation

Pregnancy Dacarbazine has been shown to be mutagenic, teratogenic and carcinogenic in animals. It must be assumed that an increased risk for teratogenic effects exists in humans. Therefore Dacarbazine ...

Effects on ability to drive and use machines

Dacarbazine may influence the ability to drive or operate machines because of its central nervous side effects or because of nausea and vomiting.

Undesirable effects

Frequencies: Very common (> 1/10) Common (> 1/100 to < 1/10) Uncommon (> 1/1000 to < 1/100) Rare (> 1/10000 to < 1/1000) Very rare (< 1/10000) Not known (cannot be estimated from the available data) The ...

Overdose

The primary anticipated complications of overdose are severe bone marrow suppression, eventually bone marrow aplasia which may be delayed by up to two weeks. Time to occurrence of nadirs of leucocytes ...

Pharmacodynamic properties

Pharmacotherapeutic group: Alkylating agents ATC code: L01AX04 Dacarbazine is a cytostatic agent. The antineoplastic effect is due to an inhibition of cell growth which is independent of the cell cycle ...

Pharmacokinetic properties

Distribution After intravenous administration dacarbazine is quickly distributed into tissue. Plasma protein binding is 5%. Kinetics in plasma are biphasic; the initial (distribution) half-life is only ...

Preclinical safety data

Because of its pharmacodynamic properties dacarbazine shows mutagenic, carcinogenic and teratogenic effects which are detectable in experimental test systems.

List of excipients

Citric acid, anhydrous Mannitol

Incompatibilities

Dacarbazine solution is chemically incompatible with heparin, hydrocortisone, L-cysteine and sodium hydrogen carbonate.

Shelf life

Shelf life: 3 years. Shelf life of the reconstituted solution of Dacarbazine medac 100 mg (200 mg): Chemical and physical in-use stability has been demonstrated for 24 hours at 20°C protected from light. ...

Special precautions for storage

Do not store above 25°C. Keep the vial in the outer carton in order to protect from light. Reconstituted solutions should also be protected from light. For storage conditions after reconstitution of the ...

Nature and contents of container

Dacarbazine medac 100 mg (200 mg) is supplied as a sterile powder for solution for injection/infusion in single-dose vials made of amber glass (Type I, Ph.Eur.) and closed with butyl rubber stoppers. Each ...

Special precautions for disposal and other handling

Recommendations for safe handling Dacarbazine is an antineoplastic agent and should be handled according to standard procedures for cytostatics that have mutagenic, carcinogenic and teratogenic effects. ...

Marketing authorization holder

medac, Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany

Marketing authorization number(s)

Dacarbazine medac 100 mg: PL 11587/0008 Dacarbazine medac 200 mg: PL 11587/0009 Dacarbazine medac 500 mg: PL 11587/0010 Dacarbazine medac 1000 mg: PL 11587/0011

Date of first authorization / renewal of the authorization

Date of first authorisation: 28 November 1997 Date of last renewal: 24 April 2010

Date of revision of the text

01/2017

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