SPC, UK: ORENCIA 250 mg powder for concentrate for solution for infusion
||Bristol-Myers Squibb Pharmaceutical Limited
||Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
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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 ...
Powder for concentrate for solution for infusion. The powder is a white to off-white whole or fragmented ...
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 ...
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 ...
Adverse reactions in adults Abatacept has been studied in patients with active rheumatoid arthritis in ...
Doses up to 50 mg/kg have been administered without apparent toxic effect. In case of overdose, it is ...
Pharmacotherapeutic group: selective immunosuppressants ATC code: L04AA24 Abatacept is a fusion protein ...
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
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...
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)
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.