KEVZARA Solution for injection (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Kevzara 150 mg solution for injection in pre-filled syringe. Kevzara 150 mg solution for injection in pre-filled pen. Kevzara 200 mg solution for injection in pre-filled syringe. Kevzara 200 mg solution ...
Qualitative and quantitative composition
150 mg solution for injection: Each single-dose pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). Each single-dose pre-filled pen contains 150 mg sarilumab in 1.14 ml solution ...
Pharmaceutical form
Solution for injection (injection). Clear, colourless to pale yellow sterile solution of approximately pH 6.0.
Therapeutic indications
Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are ...
Posology and method of administration
Treatment should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of rheumatoid arthritis. Patients treated with Kevzara should be given the patient alert ...
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Active, severe infections (see section 4.4).
Special warnings and precautions for use
Traceability of Kevzara In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Serious infections ...
Interaction with other medicinal products and other forms of interaction
Sarilumab exposure was not affected when coadministered with MTX based on the population pharmacokinetic analyses and across study comparisons. MTX exposure is not expected to be changed by sarilumab coadministration; ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use effective contraception during and up to 3 months after treatment. Pregnancy There are no or limited amount of data from the use ...
Effects on ability to drive and use machines
Kevzara has no or negligible influence on the ability to drive or operate machinery.
Undesirable effects
Summary of the safety profile The most frequent adverse reactions observed with Kevzara in clinical studies were neutropenia, increased ALT, injection site erythema, upper respiratory infections, and urinary ...
Overdose
There are limited data available on overdose with Kevzara. There is no specific treatment for Kevzara overdose. In the event of an overdose, the patient should be closely monitored, treated symptomatically, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosupressants, Interleukin inhibitors ATC code: L04AC14 Mechanism of action Sarilumab is a human monoclonal antibody (IgG1 subtype) that specifically binds to both soluble ...
Pharmacokinetic properties
The pharmacokinetics of sarilumab were characterised in 2186 patients with RA treated with sarilumab which included 751 patients treated with 150 mg and 891 patients treated with 200 mg subcutaneous doses ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on repeated-dose toxicity studies, carcinogenic risk assessment and reproductive and developmental toxicity studies. No long-term animal studies ...
List of excipients
Histidine Arginine Polysorbate 20 Sucrose Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 2 years. Once removed from the refrigerator, Kevzara should be administered within 14 days and should not be stored above 25°C.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store pre-filled syringe/pre-filled pen in the original carton in order to protect from light.
Nature and contents of container
All presentations contain a 1.14 ml solution in a syringe (type 1 glass) equipped with a stainless steel staked needle and an elastomer plunger stopper. Pre-filled syringe 150 mg: The single-use pre-filled ...
Special precautions for disposal and other handling
The pre-filled syringe/pre-filled pen should be inspected before use. The solution should not be used if it is cloudy, discoloured, or contains particles, or if any part of the device appears to be damaged. ...
Marketing authorization holder
Sanofi-aventis groupe, 54, rue La Boétie, 75008 Paris, France
Marketing authorization number(s)
EU/1/17/1196/001 EU/1/17/1196/002 EU/1/17/1196/003 EU/1/17/1196/004 EU/1/17/1196/005 EU/1/17/1196/006 EU/1/17/1196/007 EU/1/17/1196/008 EU/1/17/1196/009 EU/1/17/1196/010 EU/1/17/1196/011 EU/1/17/1196/012 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 June 2017
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