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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: ORENCIA 250 mg powder for concentrate for solution for infusion (2012)

Εκδότης

Εκδότης Bristol-Myers Squibb Pharmaceutical Limited
Διεύθυνση Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
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Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

ORENCIA 250 mg powder for concentrate for solution for infusion.

Qualitative and quantitative composition

Each vial contains 250 mg of abatacept. Each ml contains 25 mg of abatacept, after reconstitution. Abatacept ...

Pharmaceutical form

Powder for concentrate for solution for infusion. The powder is a white to off-white whole or fragmented ...

Therapeutic indications

Rheumatoid arthritis ORENCIA in combination with methotrexate is indicated for the treatment of moderate ...

Posology and method of administration

Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe and ...

Special warnings and precautions for use

Combination with TNF-inhibitors There is limited experience with use of abatacept in combination with ...

Interaction with other medicinal products and other forms of interaction

Combination with TNF-inhibitors There is limited experience with the use of abatacept in combination ...

Fertility, pregnancy and lactation

Pregnancy and Women of childbearing potential There are no adequate data from use of abatacept in pregnant ...

Effects on ability to drive and use machines

Based on its mechanism of action, abatacept is expected to have no or negligible influence on the ability ...

Undesirable effects

Adverse reactions in adults Abatacept has been studied in patients with active rheumatoid arthritis in ...

Overdose

Doses up to 50 mg/kg have been administered without apparent toxic effect. In case of overdose, it is ...

Pharmacodynamic properties

Pharmacotherapeutic group: selective immunosuppressants ATC code: L04AA24 Abatacept is a fusion protein ...

Pharmacokinetic properties

After multiple intravenous infusions (days 1, 15, 30, and every 4 weeks thereafter), the pharmacokinetics ...

Preclinical safety data

No mutagenicity or clastogenicity was observed with abatacept in a battery of in vitro studies. In a ...

List of excipients

Maltose Sodium dihydrogen phosphate monohydrate Sodium chloride

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...

Shelf life

Unopened vial: 3 years. After reconstitution: chemical and physical in-use stability has been demonstrated ...

Special precautions for storage

Store in a refrigerator (2°C 8°C). Store in the original package in order to protect from light. For ...

Nature and contents of container

Powder in a vial (15 ml Type 1 glass) with a stopper (halobutyl-rubber) and flip off seal (aluminium) ...

Special precautions for disposal and other handling

Reconstitution and dilution should be performed in accordance with good practices rules, particularly ...

Marketing authorization holder

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom ...

Marketing authorization number(s)

EU/1/07/389/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 21 May 2007.

Date of revision of the text

15 March 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.