TRISENOX Concentrate for solution for infusion (2018)
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Περιεχόμενα
Name of the medicinal product
TRISENOX 1 mg/ml concentrate for solution for infusion. TRISENOX 2 mg/ml concentrate for solution for infusion.
Qualitative and quantitative composition
TRISENOX 1 mg/ml concentrate for solution for infusion: Each ml of concentrate contains 1 mg of arsenic trioxide. Each ampoule of 10 ml contains 10 mg of arsenic trioxide. TRISENOX 2 mg/ml concentrate ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Clear, colourless, aqueous solution.
Therapeutic indications
TRISENOX is indicated for induction of remission, and consolidation in adult patients with: Νewly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤10 10 ...
Posology and method of administration
TRISENOX must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and the special monitoring procedures described in section 4.4 must be followed. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Clinically unstable APL patients are especially at risk and will require more frequent monitoring of electrolyte and glycaemia levels as well as more frequent haematologic, hepatic, renal and coagulation ...
Interaction with other medicinal products and other forms of interaction
No formal assessments of pharmacokinetic interactions between TRISENOX and other therapeutic medicinal products have been conducted. Medicinal products known to cause QT/QTc interval prolongation, hypokalaemia ...
Pregnancy and lactation
Contraception in males and females Women of childbearing potential and men must use effective contraception during treatment with TRISENOX. Pregnancy Arsenic trioxide has been shown to be embryotoxic and ...
Effects on ability to drive and use machines
TRISENOX has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Related adverse reactions of CTC grade 3 and 4 occurred in 37% of relapsed/refractory APL patients in clinical trials. The most commonly reported reactions were hyperglycaemia, ...
Overdose
If symptoms suggestive of serious acute arsenic toxicity (e.g. convulsions, muscle weakness and confusion) appear, TRISENOX must be immediately discontinued and chelating therapy with penicillamine at ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antineoplastic agents ATC code: L01XX27 Mechanism of action The mechanism of action of TRISENOX is not completely understood. Arsenic trioxide causes morphological changes ...
Pharmacokinetic properties
The inorganic, lyophilized form of arsenic trioxide, when placed into solution, immediately forms the hydrolysis product arsenious acid (As<sup>III</sup>). As<sup>III</sup> is the pharmacologically active ...
Preclinical safety data
Limited reproductive toxicity studies of arsenic trioxide in animals indicate embryotoxicity and teratogenicity (neural tube defects, anophthalmia and microphthalmia) at administration of 1-10 times the ...
List of excipients
Sodium hydroxide Hydrochloric acid (for pH adjustment) Water for injections
Incompatibilities
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
TRISENOX 1 mg/ml concentrate for solution for infusion: 4 years. TRISENOX 2 mg/ml concentrate for solution for infusion: 3 years. After dilution in intravenous solutions, TRISENOX is chemically and physically ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions after dilution of the medicinal products, see section 6.3.
Nature and contents of container
<u>TRISENOX 1 mg/ml concentrate for solution for infusion:</u> Type I borosilicate glass ampoule containing 10 ml of concentrate. Each pack contains 10 ampoules. <u>TRISENOX 2 mg/ml concentrate for solution ...
Special precautions for disposal and other handling
Preparation of TRISENOX Aseptic technique must be strictly observed throughout handling of TRISENOX since no preservative is present. TRISENOX must be diluted with 100 to 250 ml of glucose 50 mg/ml (5 ...
Marketing authorization holder
Teva B.V., Swensweg 5, 2031 GA, Haarlem, Netherlands
Marketing authorization number(s)
TRISENOX 1 mg/ml concentrate for solution for infusion: EU/1/02/204/001 TRISENOX 2 mg/ml concentrate for solution for infusion: EU/1/02/204/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 05 March 2002 Date of latest renewal: 05 March 2007
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