ORENCIA Powder for concentrate for solution for infusion (2017)
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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 is a fusion protein produced by recombinant DNA technology in Chinese hamster ovary cells. ...
Pharmaceutical form
Powder for concentrate for solution for infusion. The powder is a white to off-white whole or fragmented cake.
Therapeutic indications
Rheumatoid arthritis ORENCIA, in combination with methotrexate, is indicated for: the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous ...
Posology and method of administration
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis or JIA. If a response to abatacept is not present within 6 months ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe and uncontrolled infections such as sepsis and opportunistic infections (see section 4.4).
Special warnings and precautions for use
Combination with TNF-inhibitors There is limited experience with use of abatacept in combination with TNF-inhibitors (see section 5.1). In placebo-controlled clinical trials, in comparison with patients ...
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 with TNF-inhibitors (see section 5.1). While TNF-inhibitors did not influence abatacept clearance, in ...
Pregnancy and lactation
Pregnancy and Women of childbearing potential There are no adequate data from use of abatacept in pregnant women. In pre-clinical embryo-fetal development studies no undesirable effects were observed at ...
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 to drive and use machines. However, dizziness and reduced visual acuity have been reported as common ...
Undesirable effects
Adverse reactions in adults Summary of the safety profile in rheumatoid arthritis Abatacept has been studied in patients with active rheumatoid arthritis in placebo-controlled clinical trials (2,653 patients ...
Overdose
Doses up to 50 mg/kg have been administered without apparent toxic effect. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate ...
Pharmacodynamic properties
Pharmacotherapeutic group: selective immunosuppressants ATC code: L04AA24 Abatacept is a fusion protein that consists of the extracellular domain of human cytotoxic Tlymphocyte-associated antigen 4 (CTLA-4) ...
Pharmacokinetic properties
Adult rheumatoid arthritis After multiple intravenous infusions (days 1, 15, 30, and every 4 weeks thereafter), the pharmacokinetics of abatacept in rheumatoid arthritis patients showed dose-proportional ...
Preclinical safety data
No mutagenicity or clastogenicity was observed with abatacept in a battery of in vitro studies. In a mouse carcinogenicity study, increases in the incidence of malignant lymphomas and mammary gland tumours ...
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 products. ORENCIA should not be infused concomitantly in the same intravenous line with other medicinal ...
Shelf life
Shelf life Unopened vial: 3 years After reconstitution: chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C. From a microbiological point of view, the reconstituted solution ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Store in the original package in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Nature and contents of container
Powder in a vial (15 mL Type 1 glass) with a stopper (halobutyl-rubber) and flip off seal (aluminium) with a silicone-free syringe (polyethylene). Pack of 1 vial and 1 silicone-free syringe, and multipacks ...
Special precautions for disposal and other handling
Reconstitution and dilution should be performed in accordance with good practices rules, particularly with respect to asepsis. Reconstitution: 1. Determine the dose and the number of ORENCIA vials needed ...
Marketing authorization holder
Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
Marketing authorization number(s)
EU/1/07/389/001-003
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 May 2007 Date of latest Renewal: 21 May 2012
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