VECTIBIX Concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Vectibix 20 mg/mL concentrate for solution for infusion.
Qualitative and quantitative composition
Each mL of concentrate contains 20 mg panitumumab. Each vial contains either 100 mg of panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL. When prepared according to the instructions given in section ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Colourless, pH 5.6 to 6.0 solution that may contain translucent to white, visible amorphous, proteinaceous panitumumab particles.
Therapeutic indications
Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): in first-line in combination with FOLFOX or FOLFIRI. in second-line in combination with ...
Posology and method of administration
Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy. Evidence of wild-type RAS (KRAS and NRAS) status is required before initiating treatment with Vectibix. ...
Contraindications
Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4). Patients with interstitial pneumonitis ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Dermatologic reactions and soft ...
Interaction with other medicinal products and other forms of interaction
Data from an interaction study involving Vectibix and irinotecan in patients with mCRC indicated that the pharmacokinetics of irinotecan and its active metabolite, SN-38, are not altered when the medicinal ...
Pregnancy and lactation
Pregnancy There are no adequate data from the use of Vectibix in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. EGFR has ...
Effects on ability to drive and use machines
Vectibix may have a minor influence on the ability to drive and use machines. If patients experience treatment-related symptoms affecting their vision and/or ability to concentrate and react, it is recommended ...
Undesirable effects
Summary of safety profile Based on an analysis of all mCRC clinical trial patients receiving Vectibix monotherapy and in combination with chemotherapy (n=2,224), the most commonly reported adverse reactions ...
Overdose
Doses up to 9 mg/kg have been tested in clinical trials. There have been reports of overdose at doses up to approximately twice the recommended therapeutic dose (12 mg/kg). Adverse events observed included ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC08 Mechanism of action Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity ...
Pharmacokinetic properties
Vectibix administered as a single agent or in combination with chemotherapy exhibits nonlinear pharmacokinetics. Following a single-dose administration of panitumumab as a 1-hour infusion, the area under ...
Preclinical safety data
Adverse reactions seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: Skin rash and diarrhoea were the major findings observed ...
List of excipients
Sodium chloride Sodium acetate trihydrate Acetic acid, glacial (for pH-adjustment) Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Vial: 3 years. Diluted solution: Vectibix does not contain any antimicrobial preservative or bacteriostatic agent. The product should be used immediately after dilution. If not used immediately, in-use ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original 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
Type I glass vial with an elastomeric stopper, aluminium seal and flip-off plastic cap. One vial contains either 100 mg of panitumumab in 5 mL, or 400 mg panitumumab in 20 mL of concentrate for solution ...
Special precautions for disposal and other handling
Vectibix is intended for single use only. Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection by healthcare professional using aseptic technique. Do not shake or vigorously ...
Marketing authorization holder
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Marketing authorization number(s)
EU/1/07/423/001 EU/1/07/423/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 3 December 2007 Date of latest renewal: 15 January 2015
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