Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του Galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα
®
 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

KADCYLA Powder for concentrate for solution for infusion (2020)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

Name of the medicinal product

Kadcyla 100 mg powder for concentrate for solution for infusion. Kadcyla 160 mg powder for concentrate for solution for infusion.

Qualitative and quantitative composition

Kadcyla 100 mg powder for concentrate for solution for infusion: One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine. After reconstitution one vial of ...

Pharmaceutical form

Powder for concentrate for solution for infusion. White to off-white lyophilised powder.

Therapeutic indications

Early Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast ...

Posology and method of administration

Kadcyla should only be prescribed by a physician and administered as an intravenous infusion under the supervision of a healthcare professional who is experienced in the treatment of cancer patients (i.e. ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded (or stated) in the patient file. In order to ...

Interaction with other medicinal products and other forms of interaction

No formal interaction studies have been performed. In vitro metabolism studies in human liver microsomes suggest that DM1, a component of trastuzumab emtansine, is metabolised mainly by CYP3A4 and, to ...

Pregnancy and lactation

Contraception in males and females Women of childbearing potential should use effective contraception while receiving trastuzumab emtansine and for 7 months following the last dose of trastuzumab emtansine. ...

Effects on ability to drive and use machines

Trastuzumab emtansine has minor influence on the ability to drive and use machines. The significance of reported adverse reactions such as fatigue, headache, dizziness and blurred vision on the ability ...

Undesirable effects

Summary of the safety profile The safety of trastuzumab emtansine has been evaluated in 2,611 breast cancer patients in clinical studies. In this patient population: the most common serious ADRs (>0.5% ...

Overdose

There is no known antidote for trastuzumab emtansine overdose. In case of overdose, the patient should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, monoclonal antibodies ATC code: L01XC14 Mechanism of action Kadcyla, trastuzumab emtansine, is a HER2-targeted antibody-drug ...

Pharmacokinetic properties

The population pharmacokinetic analysis suggested no difference in trastuzumab emtansine exposure based on disease status (adjuvant vs. metastatic setting). Absorption Trastuzumab emtansine is administered ...

Preclinical safety data

Animal toxicology and/or pharmacology Administration of trastuzumab emtansine was well tolerated in rats and monkeys at doses up to 20 and 10 mg/kg, respectively, corresponding to 2040 μg DM1/m² in both ...

List of excipients

Succinic acid Sodium hydroxide Sucrose Polysorbate 20

Incompatibilities

This medicinal product must not be mixed or diluted with other medicinal products except those mentioned in section 6.6. Glucose (5%) solution should not be used for reconstitution or dilution since it ...

Shelf life

Shelf life Unopened vial: 3 years. Reconstituted solution: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to 24 hours at 2°C to 8°C. From a microbiological ...

Special precautions for storage

Store in a refrigerator (2°C–8°C). For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

Nature and contents of container

Kadcyla 100 mg powder for concentrate for solution for infusion: Kadcyla is provided in 15 mL (100 mg) Type 1 glass vial closed with a grey-butyl rubber stopper coated with fluoro-resin laminate, and sealed ...

Special precautions for disposal and other handling

Appropriate aseptic technique should be used. Appropriate procedures for the preparation of chemotherapeutic medicinal products should be used. The reconstituted Kadcyla solution should be diluted in polyvinyl ...

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Marketing authorization number(s)

EU/1/13/885/001 EU/1/13/885/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 15 November 2013 Date of latest renewal: 17 September 2018

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: