PERJETA Concentrate for solution for infusion (2021)
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Περιεχόμενα
Name of the medicinal product
Perjeta 420 mg concentrate for solution for infusion.
Qualitative and quantitative composition
One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml. After dilution, one ml of solution contains approximately 3.02 mg of pertuzumab for the initial dose and approximately ...
Pharmaceutical form
Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale yellow, liquid.
Therapeutic indications
Early breast cancer Perjeta is indicated for use in combination with trastuzumab and chemotherapy in: the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or ...
Posology and method of administration
Perjeta should only be initiated under the supervision of a physician experienced in the administration of anti-cancer agents. Perjeta should be administered by a healthcare professional prepared to manage ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. Left ventricular dysfunction (including ...
Interaction with other medicinal products and other forms of interaction
No pharmacokinetic (PK) interactions were observed between pertuzumab and trastuzumab, or between pertuzumab and docetaxel in a sub-study of 37 patients in the randomised, pivotal trial CLEOPATRA in metastatic ...
Pregnancy and lactation
Contraception Women of childbearing potential should use effective contraception while receiving Perjeta and for 6 months following the last dose of pertuzumab. Pregnancy There is limited amount of data ...
Effects on ability to drive and use machines
On the basis of reported adverse reactions, Perjeta has a minor influence on the ability to drive or use machines. Dizziness may occur during treatment with Perjeta (see section 4.8). Patients experiencing ...
Undesirable effects
Summary of the safety profile The safety of Perjeta has been evaluated in more than 6,000 patients in Phase I, II, and III trials in patients with various malignancies and predominantly treated with Perjeta ...
Overdose
The maximum tolerated dose of pertuzumab has not been determined. In clinical trials, single doses higher than 25 mg/kg (1727 mg) have not been tested. In case of overdose, patients must be closely monitored ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antineoplastic agents, monoclonal antibodies <b>ATC code:</b> L01XC13 Mechanism of action Pertuzumab is a recombinant humanised monoclonal antibody that specifically targets ...
Pharmacokinetic properties
A population pharmacokinetic analysis was performed with data from 481 patients across different clinical trials (phase I, II and III) with various types of advanced malignancies who had received Perjeta ...
Preclinical safety data
No specific fertility studies in animals have been performed to evaluate the effect of pertuzumab. No definitive conclusion on adverse effects can be drawn on the male reproductive organs in cynomolgus ...
List of excipients
Glacial acetic acid L-Histidine Sucrose Polysorbate 20 Water for injections
Incompatibilities
Glucose (5%) solution should not be used to dilute Perjeta since it is chemically and physically unstable in such solutions. This medicinal product must not be mixed with other medicinal products except ...
Shelf life
<u>Unopened vial:</u> 2 years. <u>Diluted solution:</u> Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C. From a microbiological point of view, the product should be used ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
Vial (Type I glass) with a stopper (butyl rubber) containing 14 ml of solution. Pack of 1 vial.
Special precautions for disposal and other handling
Perjeta does not contain any antimicrobial preservative. Therefore, care must be taken to ensure the sterility of the prepared solution for infusion and should be prepared by a healthcare professional. ...
Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Marketing authorization number(s)
EU/1/13/813/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 4<sup>th</sup> March 2013 Date of latest renewal: 8<sup>th</sup> December 2017
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