DACARBAZINE Powder for solution for injection or infusion (2017)
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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