OLUMIANT Film-coated tablets (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Olumiant 2 mg film-coated tablets. Olumiant 4 mg film-coated tablets.
Qualitative and quantitative composition
Olumiant 2 mg film-coated tablets: Each film-coated tablet contains 2 mg baricitinib. Olumiant 4 mg film-coated tablets: Each film-coated tablet contains 4 mg baricitinib. For the full list of excipients, ...
Pharmaceutical form
Film-coated tablet (tablet). Olumiant 2 mg film-coated tablets: Light pink, 9.0 7.5 mm oblong tablets, debossed with Lilly on one side and 2 on the other. Olumiant 4 mg film-coated tablets: Medium pink, ...
Therapeutic indications
Olumiant is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic ...
Posology and method of administration
Treatment should be initiated by physicians experienced in the diagnosis and treatment of rheumatoid arthritis. Posology The recommended dose of Olumiant is 4 mg once daily. A dose of 2 mg once daily is ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6).
Special warnings and precautions for use
Infections Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo (see section 4.8). In treatment naïve patients, combination with ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Immunosuppressive medicinal products Combination with biologic DMARDs or other JAK inhibitors has not been studied. Use of baricitinib with potent immunosuppressive medicinal ...
Fertility, pregnancy and lactation
Pregnancy The JAK/STAT pathway has been shown to be involved in cell adhesion and cell polarity which can affect early embryonic development. There are no adequate data from the use of baricitinib in pregnant ...
Effects on ability to drive and use machines
Olumiant has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of safety profile The most commonly reported adverse drug reactions (ADRs) occurring in ≥ 2% of patients treated with Olumiant monotherapy or in combination with conventional synthetic DMARDs were ...
Overdose
Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered in clinical trials without dose-limiting toxicity. Adverse events were comparable to those seen at lower ...
Pharmacodynamic properties
Pharmacotherapeutic group: Selective immunosuppressants ATC code: L04AA37 Mechanism of action Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2. In isolated enzyme assays, ...
Pharmacokinetic properties
Following oral administration of baricitinib, a dose-proportional increase in systemic exposure was observed in the therapeutic dose range. The PK of baricitinib is linear with respect to time. Absorption ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential. Decreases in lymphocytes, eosinophils and basophils ...
List of excipients
Tablet cores: cellulose, microcrystalline croscarmellose sodium magnesium stearate mannitol Film coating: iron oxide red (E172) lecithin (soya) (E322) macrogol poly (vinyl alcohol) talc titanium dioxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene aluminium blisters in cartons of 14, 28, 35, 56, 84 or 98 film-coated tablets. Polyvinylchloride/aluminium/oriented polyamide aluminium perforated ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
Marketing authorization number(s)
Olumiant 2 mg film-coated tablets: EU/1/16/1170/001 EU/1/16/1170/002 EU/1/16/1170/003 EU/1/16/1170/004 EU/1/16/1170/005 EU/1/16/1170/006 EU/1/16/1170/007 EU/1/16/1170/008 Olumiant 4 mg film-coated tablets: ...
Date of first authorization / renewal of the authorization
Date of first Authorisation: 13 February 2017
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