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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: Caelyx 2mg/ml concentrate for solution for infusion (2011)

Εκδότης

Εκδότης Janssen-Cilag Ltd
Διεύθυνση 50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
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

Caelyx 2 mg/ml concentrate for solution for infusion.

Qualitative and quantitative composition

One ml of Caelyx contains 2 mg doxorubicin hydrochloride in a pegylated liposomal formulation. Caelyx ...

Pharmaceutical form

Concentrate for solution for infusion The suspension is sterile, translucent and red.

Therapeutic indications

Caelyx is indicated: As monotherapy for patients with metastatic breast cancer, where there is an increased ...

Posology and method of administration

Caelyx should only be administered under the supervision of a qualified oncologist specialised in the ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Caelyx must not be used to treat ...

Special warnings and precautions for use

Cardiac toxicity: It is recommended that all patients receiving Caelyx routinely undergo frequent ECG ...

Interaction with other medicinal products and other forms of interaction

No formal medicinal product interaction studies have been performed with Caelyx, although phase II combination ...

Pregnancy and lactation

Pregnancy Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during ...

Effects on ability to drive and use machines

Caelyx has no or negligible influence on the ability to drive and use machines. However, in clinical ...

Undesirable effects

The most common undesirable effect reported in breast/ovarian clinical trials (50 mg/m2 every 4 weeks) ...

Overdose

Acute overdosing with doxorubicin hydrochloride worsens the toxic effects of mucositis, leukopaenia and ...

Pharmacodynamic properties

Pharmacotherapeutic group: Cytotoxic agents (anthracyclines and related substances) ATC code: L01DB ...

Pharmacokinetic properties

Caelyx is a long-circulating pegylated liposomal formulation of doxorubicin hydrochloride. Pegylated ...

Preclinical safety data

In repeat dose studies conducted in animals, the toxicity profile of Caelyx appears very similar to that ...

List of excipients

α-(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-ω-methoxypoly(oxyethylen)-40 sodium salt ...

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

20 months. After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours ...

Special precautions for storage

Store in a refrigerator (2°C 8°C). Do not freeze. For storage conditions of the diluted medicinal product, ...

Nature and contents of container

Type I glass vials, each with a siliconised grey bromobutyl stopper, and an aluminium seal, with a deliverable ...

Special precautions for disposal and other handling

Do not use material that shows evidence of precipitation or any other particulate matter. Caution must ...

Marketing authorization holder

Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium

Marketing authorization number(s)

EU/1/96/011/001 EU/1/96/011/002 EU/1/96/011/003 EU/1/96/011/004

Date of first authorization / renewal of the authorization

Date of first authorization: 21 June 1996 Date of last renewal: 19 May 2006

Date of revision of the text

11/2010
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.