CYRAMZA Concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Cyramza 10 mg/ml concentrate for solution for infusion.
Qualitative and quantitative composition
One ml of concentrate for solution for infusion contains 10 mg ramucirumab. Each 10 ml vial contains 100 mg of ramucirumab. Each 50 ml vial contains 500 mg of ramucirumab. Ramucirumab is a human IgG1 monoclonal ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear to slightly opalescent and colourless to slightly yellow solution, pH 6.0.
Therapeutic indications
Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression ...
Posology and method of administration
Ramucirumab therapy must be initiated and supervised by physicians experienced in oncology. Posology Gastric cancer and gastro-oesophageal junction (GEJ) adenocarcinoma Cyramza in combination with paclitaxel ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. For patients with NSCLC, ramucirumab is contraindicated where there is tumour cavitation or tumour involvement ...
Special warnings and precautions for use
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Arterial thromboembolic events Serious, ...
Interaction with other medicinal products and other forms of interaction
No drug-drug interactions were observed between ramucirumab and paclitaxel. The pharmacokinetics of paclitaxel were not affected when co-administered with ramucirumab and the pharmacokinetics of ramucirumab ...
Pregnancy and lactation
Women of childbearing potential / Contraception in females Women of childbearing potential should be advised to avoid becoming pregnant while on Cyramza and should be informed of the potential hazard to ...
Effects on ability to drive and use machines
Cyramza has no or negligible influence on the ability to drive and use machines. If patients experience symptoms affecting their ability to concentrate and react, it is recommended that they do not drive ...
Undesirable effects
Summary of the safety profile The most serious adverse reactions associated with ramucirumab treatment (as a single agent or in combination with cytotoxic chemotherapy) were: Gastrointestinal perforation ...
Overdose
There is no data on overdose in humans. Cyramza has been administered in a Phase 1 study up to 10 mg/kg every two weeks without reaching a maximum tolerated dose. In case of overdose, supportive therapy ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC21 Mechanism of action Vascular Endothelial Growth Factor (VEGF) Receptor 2 is the key mediator of VEGF induced angiogenesis. ...
Pharmacokinetic properties
Following the dose regimen of 8 mg/kg every 2 weeks, the geometric means of ramucirumab C<sub>min</sub> prior to administration of the fourth and seventh dose of ramucirumab given as a single agent in ...
Preclinical safety data
No animal studies have been performed to test ramucirumab for potential of carcinogenicity or genotoxicity. The target organs identified in repeated dose cynomolgus monkey toxicity studies were kidney ...
List of excipients
Histidine Histidine monohydrochloride Sodium chloride Glycine (E640) Polysorbate 80 (E433) Water for injections
Incompatibilities
Cyramza should not be administered or mixed with dextrose solutions. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial: 3 years. After dilution: When prepared as directed, infusion solutions of Cyramza contain no antimicrobial preservatives. Chemical and physical in-use stability of Cyramza in ...
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
10 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap. 50 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium ...
Special precautions for disposal and other handling
Do not shake the vial. Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution. Each vial is intended for single use only. Inspect the content of the vials ...
Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Marketing authorization number(s)
EU/1/14/957/001-003
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 December 2014 Date of latest renewal: 26 September 2019
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