ORENCIA Solution for injection (2017)
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Περιεχόμενα
Name of the medicinal product
ORENCIA 125 mg solution for injection in pre-filled syringe.
Qualitative and quantitative composition
Each pre-filled syringe contains 125 mg of abatacept in one mL. Abatacept is a fusion protein produced by recombinant DNA technology in Chinese hamster ovary cells. For the full list of excipients, see ...
Pharmaceutical form
Solution for injection (injection) in pre-filled syringe. The solution is clear, colorless to pale yellow with a pH of 6.8 to 7.4.
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. If a response to abatacept is not present within 6 months of treatment, ...
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 ...
Fertility, 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
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 with abatacept, 1,485 ...
Overdose
Doses up to 50 mg/kg have been administered intravenously without apparent toxic effect. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions ...
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 The geometric mean estimate (90% confidence interval) for the bioavailability of abatacept following subcutaneous administration relative to intravenous administration is 78.6% ...
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
Sucrose Poloxamer 188 Sodium dihydrogen phosphate monohydrate Disodium phosphate anhydrous Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light.
Nature and contents of container
One mL pre-filled syringe (Type 1 glass) with flange extenders or one mL pre-filled syringe with a passive needle safety guard and flange extenders. The Type 1 glass syringe has a coated stopper and fixed ...
Special precautions for disposal and other handling
The medicinal product is for single use only. After removing the pre-filled syringe from the refrigerator the pre-filled syringe should be allowed to reach room temperature by waiting 30 minutes, before ...
Marketing authorization holder
Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
Marketing authorization number(s)
EU/1/07/389/004-010
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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