ENTYVIO 300 mg Powder for concentrate for solution for infusion (2024)
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Περιεχόμενα
Name of the medicinal product
Entyvio 300 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 300 mg of vedolizumab. After reconstitution, each mL contains 60 mg of vedolizumab. Vedolizumab is a humanised IgG<sub>1</sub> monoclonal antibody produced in Chinese hamster ovary (CHO) ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White to off-white lyophilised cake or powder.
Therapeutic indications
Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant ...
Posology and method of administration
Treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis, Crohns disease or pouchitis (see section 4.4). Patients ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections ...
Special warnings and precautions for use
Intravenous vedolizumab should be administered in a healthcare setting equipped to allow management of acute hypersensitivity reactions including anaphylaxis, if they occur. Appropriate monitoring and ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Vedolizumab has been studied in adult ulcerative colitis and Crohns disease patients with concomitant administration of corticosteroids, immunomodulators (azathioprine, ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use adequate contraception to prevent pregnancy and to continue its use for at least 18 weeks after the last treatment. Pregnancy ...
Effects on ability to drive and use machines
Vedolizumab has minor influence on the ability to drive and use machines, as dizziness has been reported in a small number of patients.
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection, bronchitis, influenza and sinusitis), headache, nausea, ...
Overdose
Doses up to 10 mg/kg (approximately 2.5 times the recommended dose) have been administered intravenously in clinical trials. No dose-limiting toxicity was seen in clinical trials.
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> immunosuppressants, monoclonal antibodies <b>ATC code:</b> L04AG05 Mechanism of action Vedolizumab is a gut-selective immunosuppressive biologic. It is a humanised monoclonal ...
Pharmacokinetic properties
The single and multiple dose pharmacokinetics of vedolizumab have been studied in healthy subjects and in patients with moderate to severely active ulcerative colitis or Crohns disease. The pharmacokinetics ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
List of excipients
L-histidine L-histidine monohydrochloride L-arginine hydrochloride Sucrose Polysorbate 80
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. In-use stability of the reconstituted solution in the vial has been demonstrated for 8 hours at 2°C-8°C. In-use stability of the diluted solution in sodium chloride 9 mg/mL (0.9%) solution for ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3. ...
Nature and contents of container
Powder for concentrate for solution for infusion in Type 1 glass vial (20 mL) fitted with rubber stopper and aluminium crimp protected by a plastic cap. Each pack contains 1 vial.
Special precautions for disposal and other handling
<u>Instructions for reconstitution and infusion:</u> Use aseptic technique when preparing Entyvio solution for intravenous infusion. Remove flip-off cap from the vial and wipe with alcohol swab. Reconstitute ...
Marketing authorization holder
Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark, medinfoEMEA@takeda.com
Marketing authorization number(s)
EU/1/14/923/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 May 2014 Date of latest renewal: 12 December 2018
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