ZALTRAP Concentrate for solution for infusion (2017)
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Περιεχόμενα
Name of the medicinal product
ZALTRAP 25 mg/ml concentrate for solution for infusion.
Qualitative and quantitative composition
One ml of concentrate for solution for infusion contains 25 mg aflibercept*. One vial of 4 ml of concentrate contains 100 mg of aflibercept. One vial of 8 ml of concentrate contains 200 mg of aflibercept. ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear colourless to pale yellow solution.
Therapeutic indications
ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an ...
Posology and method of administration
ZALTRAP should be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Posology The recommended dose of ZALTRAP, administered as an intravenous ...
Contraindications
Hypersensitivity to aflibercept or to any of the excipients listed in section 6.1. Ophthalmic/intravitreal use due to hyperosmotic properties of ZALTRAP (see section 4.4). For contraindications related ...
Special warnings and precautions for use
Haemorrhage An increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events has been reported in patients treated with aflibercept (see section 4.8). Patients should be monitored ...
Interaction with other medicinal products and other forms of interaction
Population pharmacokinetics analysis and inter study comparisons did not reveal any pharmacokinetic drug-drug interaction between aflibercept and the FOLFIRI regimen.
Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while on ZALTRAP, and should be informed of the potential ...
Effects on ability to drive and use machines
ZALTRAP has no or negligible influence on the ability to drive and use machines. If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should ...
Undesirable effects
Summary of the safety profile The safety of ZALTRAP in combination with FOLFIRI was evaluated in 1,216 patients previously treated for metastatic colorectal cancer, of which 611 patients were treated with ...
Overdose
There is no information on the safety of aflibercept given at doses exceeding 7 mg/kg every 2 weeks or 9 mg/kg every 3 weeks. The most commonly observed adverse reactions at these doses were similar to ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents ATC code: L01XX44 Mechanism of action Vascular endothelial growth factor A and B (VEGF-A, VEGF-B), and placental growth factor ...
Pharmacokinetic properties
Absorption In preclinical tumour models, biologically active doses of aflibercept correlated with those necessary to produce circulating concentrations of free aflibercept in excess of VEGF-bound aflibercept. ...
Preclinical safety data
Animal toxicology and pharmacology Weekly/every two weeks intravenous administration of aflibercept to cynomolgus monkeys for up to 6 months resulted in changes in the bone (effects on growth plate and ...
List of excipients
Sucrose Sodium chloride Sodium citrate dihydrate Citric acid monohydrate Polysorbate 20 Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Sodium hydroxide and/or hydrochloric ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial: 3 years. After dilution in the infusion bag: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C and for 8 hours at 25°C. From a microbiological ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Store in the original package in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
4 ml of concentrate in a 5 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc. Pack size of 1 vial or 3 vials. 8 ml of concentrate ...
Special precautions for disposal and other handling
ZALTRAP is a sterile, preservative-free and non-pyrogenic concentrate, therefore the solution for infusion should be prepared by a healthcare professional using safe-handling procedures and aseptic technique. ...
Marketing authorization holder
sanofi-aventis groupe, 54, rue La Boétie, 75008 Paris, France
Marketing authorization number(s)
EU/1/12/814/001 EU/1/12/814/002 EU/1/12/814/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 February 2013
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