XELJANZ Film-coated tablet (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
XELJANZ 5 mg film-coated tablets. XELJANZ 10 mg film-coated tablets.
Qualitative and quantitative composition
XELJANZ 5 mg film-coated tablets Each film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib. <u>Excipient with known effect:</u> Each film-coated tablet contains 59.44 mg of lactose. ...
Pharmaceutical form
Film-coated tablet (tablet). <u>Tofacitinib 5 mg film-coated tablets:</u> White, round tablet of 7.9 mm diameter, debossed Pfizer on one side and JKI 5 on the other. <u>Tofacitinib 10 mg film-coated tablets: ...
Therapeutic indications
Rheumatoid arthritis Tofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately ...
Posology and method of administration
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which tofacitinib is indicated. Posology Rheumatoid arthritis and psoriatic ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections (see section 4.4). ...
Special warnings and precautions for use
Tofacitinib should only be used if no suitable treatment alternatives are available in patients: 65 years of age and older; patients with history of atherosclerotic cardiovascular disease or other cardiovascular ...
Interaction with other medicinal products and other forms of interaction
Potential for other medicinal products to influence the pharmacokinetics (PK) of tfacitinib Since tofacitinib is metabolised by CYP3A4, interaction with medicinal products that inhibit or induce CYP3A4 ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies on the use of tofacitinib in pregnant women. Tofacitinib has been shown to be teratogenic in rats and rabbits, and to affect parturition and ...
Effects on ability to drive and use machines
Tofacitinib has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Rheumatoid arthritis The most common serious adverse reactions were serious infections (see section 4.4). In the long-term safety all exposure population, the most common ...
Overdose
In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. There is no specific antidote for overdose with tofacitinib. Treatment should be symptomatic ...
Pharmacodynamic properties
<b>Pharmacotherapeutic groups:</b> Immunosuppressants, Selective Immunosuppressants <b>ATC code:</b> L04AA29 Mechanism of action Tofacitinib is a potent, selective inhibitor of the JAK family. In enzymatic ...
Pharmacokinetic properties
The PK profile of tofacitinib is characterised by rapid absorption (peak plasma concentrations are reached within 0.5-1 hour), rapid elimination (half-life of ~3 hours) and dose-proportional increases ...
Preclinical safety data
In non-clinical studies, effects were observed on the immune and haematopoietic systems that were attributed to the pharmacological properties (JAK inhibition) of tofacitinib. Secondary effects from immunosuppression, ...
List of excipients
<u>Tablet core:</u> Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate <u>Film coat:</u> Hypromellose 6cP (E464) Titanium dioxide (E171) Lactose monohydrate Macrogol ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Nature and contents of container
XELJANZ 5 mg film-coated tablets: HDPE bottles with silica gel desiccant and child-resistant polypropylene closure containing 60 or 180 film-coated tablets. Aluminium foil/PVC backed aluminium foil blisters ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Marketing authorization number(s)
EU/1/17/1178/001 EU/1/17/1178/002 EU/1/17/1178/003 EU/1/17/1178/004 EU/1/17/1178/005 EU/1/17/1178/006 EU/1/17/1178/007 EU/1/17/1178/008 EU/1/17/1178/009 EU/1/17/1178/014
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 March 2017
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