NULOJIX Powder for concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
NULOJIX 250 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 250 mg of belatacept. After reconstitution, each ml of concentrate contains 25 mg belatacept. Belatacept is a fusion protein produced in Chinese hamster ovary cells by recombinant DNA ...
Pharmaceutical form
Powder for concentrate for solution for infusion (powder for concentrate). The powder is a white to off-white whole or fragmented cake.
Therapeutic indications
NULOJIX, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adults receiving a renal transplant (see section 5.1 for data on renal function). ...
Posology and method of administration
Treatment should be prescribed and supervised by specialist physicians experienced in the management of immunosuppressive therapy and of renal transplant patients. Belatacept has not been studied in patients ...
Contraindications
Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4). ...
Special warnings and precautions for use
Post-transplant lymphoproliferative disorder (PTLD) In the Phase 2 and 3 studies (3 studies), the incidence of PTLD was higher in belatacept-treated patients than in ciclosporin-treated patients (see section ...
Interaction with other medicinal products and other forms of interaction
Belatacept is a fusion protein that is not expected to be metabolised by the cytochrome P450 enzymes (CYPs) and UDP-glucuronosyltransferases (UGTs). Belatacept appears not to have any relevant direct effects ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing potential should use effective contraception during treatment with belatacept and up to 8 weeks after the last dose ...
Effects on ability to drive and use machines
Belatacept has a minor influence on the ability to drive and use machines since it may cause fatigue, malaise and/or nausea. Patients should be instructed that if they experience these symptoms they should ...
Undesirable effects
Summary of the safety profile The adverse reaction profile associated with immunosuppressive agents is often difficult to establish due to the underlying disease and the concurrent use of multiple medicinal ...
Overdose
Single doses up to 20 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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants ATC code: L04AA28 Belatacept, a selective costimulation blocker, is a soluble fusion protein consisting of a modified extracellular ...
Pharmacokinetic properties
Absorption The pharmacokinetics of belatacept in renal transplant patients and healthy subjects appeared to be comparable. The pharmacokinetics of belatacept was linear and the exposure to belatacept increased ...
Preclinical safety data
Belatacept has less activity in rodents than abatacept, a fusion protein that differs from belatacept by two amino acids in the CD80/86 binding domains. Because of abatacepts similarity to belatacept in ...
List of excipients
Sucrose Sodium dihydrogen phosphate monohydrate Sodium chloride Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. NULOJIX should not be used with siliconised syringes in order to avoid aggregate formation ...
Shelf life
Shelf life Unopened vials: 3 years. After reconstitution: The reconstituted solution should be transferred from the vial to the infusion bag or bottle immediately. After dilution: Chemical and physical ...
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 or dilution of the medicinal product, see section 6.3.
Nature and contents of container
NULOJIX is supplied in a 20 ml vial (Type I flint glass) with a stopper (20 mm grey butyl rubber) and flip off seal (aluminum). Each vial is co-packaged with a disposable polypropylene syringe. Pack sizes: ...
Special precautions for disposal and other handling
Use aseptic technique to reconstitute the vials and dilute the solution for administration. Use the silicone-free disposable syringe provided to make up the vials and to add the solution to the infusion. ...
Marketing authorization holder
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Marketing authorization number(s)
EU/1/11/694/001-002
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 June 2011 Date of latest renewal: 18 February 2016
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