KADCYLA Powder for concentrate for solution for infusion (2020)
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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
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