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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Cardioxane 500mg powder for solution for infusion (2012)

Εκδότης

Εκδότης Novartis Pharmaceuticals UK Ltd
Διεύθυνση Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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

CARDIOXANE® 500mg, powder for solution for infusion.

Qualitative and quantitative composition

Dexrazoxane 500.00mg as its hydrochloride salt. For a vial of powder. For a full list of excipients, ...

Pharmaceutical form

Powder for solution for infusion. Sterile, pyrogen free, white to off-white, lyophilised powder.

Therapeutic indications

Prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin use in advanced and/or ...

Posology and method of administration

Posology CARDIOXANE is administered by a short intravenous infusion (15 minutes), approximately 30 minutes ...

Contraindications

Children and adolescents up to 18 years of age (see sections 4.4 and 4.8) Patients who are hypersensitive ...

Special warnings and precautions for use

Myelosuppressive effects that may be additive to those of chemotherapy were reported with CARDIOXANE ...

Interaction with other medicinal products and other forms of interaction

CARDIOXANE may increase haematological toxicity induced by chemotherapy or radiation, requiring careful ...

Fertility, pregnancy and lactation

Women of childbearing potential/contraception in males and females Both sexually active men and women ...

Effects on ability to drive and use machines

Patients should be advised to be cautious when driving or using machines if they experience fatigue during ...

Undesirable effects

CARDIOXANE is administered together with anthracycline chemotherapy and, consequently, the relative contributions ...

Overdose

The signs and symptoms of overdose are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment ATC code: V03AF02 The exact ...

Pharmacokinetic properties

After intravenous administration to cancer patients, serum kinetics of dexrazoxane generally follow an ...

Preclinical safety data

Preclinical studies indicate that, with repeated dexrazoxane administration, the primary target organs ...

List of excipients

Not applicable.

Incompatibilities

Incompatibilities with other medicinal products or materials are not known. However CARDIOXANE should ...

Shelf life

Before opening: 3 years. After reconstitution and dilution: Chemical and physical in-use stability of ...

Special precautions for storage

Recommendations for safe handling Prescribers should refer to national or recognised guidelines on handling ...

Special precautions for storage

Before opening: Do not store above 25°C. In order to protect from light store in the original package. ...

Nature and contents of container

Vials (Type I brown glass), containing 500 mg of powder, closed with a chlorobutyl rubber stopper and ...

Marketing authorization holder

Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR

Marketing authorization number(s)

PL 00101/0937

Date of first authorization / renewal of the authorization

1 September 2006 / 16 February 2012

Date of revision of the text

16 February 2012
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.