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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Trisenox 1 mg/ml concentrate for solution for infusion (2012)

Εκδότης

Εκδότης Cephalon (UK) Limited
Διεύθυνση Teva UK Limited, Field House, Station Approach, Harlow, Essex, CM20 2FB
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

TRISENOX 1 mg/ml, concentrate for solution for infusion.

Qualitative and quantitative composition

One ml of TRISENOX contains 1 mg of Arsenic trioxide. For a full list of excipients, see section 6.1 ...

Pharmaceutical form

Concentrate for solution for infusion. Sterile, clear, colourless, aqueous solution.

Therapeutic indications

TRISENOX is indicated for induction of remission and consolidation in adult patients with relapsed/refractory ...

Posology and method of administration

Posology TRISENOX must be administered under the supervision of a physician who is experienced in the ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

Clinically unstable APL patients are especially at risk and will require more frequent monitoring of ...

Interaction with other medicinal products and other forms of interaction

No formal assessments of pharmacokinetic interactions between TRISENOX and other therapeutic medicinal ...

Fertility, pregnancy and lactation

Contraception in males and females Men and women of childbearing potential must use effective contraception ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

Related adverse reactions of CTC grade 3 and 4 occurred in 37% of patients in clinical trials. The most ...

Overdose

If symptoms suggestive of serious acute arsenic toxicity (e.g. convulsions, muscle weakness and confusion) ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other antineoplastic agents ATC code: L01XX27 Mechanism of action: The mechanism ...

Pharmacokinetic properties

The inorganic, lyophilized form of arsenic trioxide, when placed into solution, immediately forms the ...

Preclinical safety data

Limited reproductive toxicity studies of arsenic trioxide in animals indicate embryotoxicity and teratogenicity ...

List of excipients

Sodium hydroxide Hydrochloric acid as pH adjuster Water for injections

Incompatibilities

In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal ...

Shelf life

4 years. After dilution in intravenous solutions, TRISENOX is chemically and physically stable for 24 ...

Special precautions for storage

Do not freeze.

Nature and contents of container

Type I borosilicate glass ampoule of 10 ml. Each pack contains 10 ampoules.

Special precautions for disposal and other handling

Preparation of TRISENOX Aseptic technique must be strictly observed throughout handling of TRISENOX since ...

Marketing authorization holder

Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort FRANCE

Marketing authorization number(s)

EU/1/02/204/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 05 March 2002 Date of latest renewal: 05 March 2007

Date of revision of the text

November 2011
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.