Simulect 10mg and 20mg powder and solvent for solution for injection or infusion (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Novartis Pharmaceuticals UK Ltd |
|---|---|
| Διεύθυνση | Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR |
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Name of the medicinal product
Simulect 10 mg powder and solvent for solution for injection or infusion. Simulect 20 mg powder and solvent for solution for injection or infusion.
Qualitative and quantitative composition
Each vial contains 10 or 20 mg basiliximab*. One ml of the reconstituted solution contains 4 mg basiliximab. * recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 receptor ...
Pharmaceutical form
Powder and solvent for solution for injection or infusion. White powder.
Therapeutic indications
Simulect is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients (1-17 years) (see section 4.2). It is to be used concomitantly ...
Posology and method of administration
Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. Simulect should be administered under qualified medical supervision. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients (see section 6.1). Pregnancy and lactation (see section 4.6).
Special warnings and precautions for use
Patients receiving Simulect must be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources, including medications for the treatment of severe hypersensitivity ...
Interaction with other medicinal products and other forms of interaction
Because basiliximab is an immunoglobulin, no metabolic drug-drug interactions are to be expected. In addition to ciclosporin for microemulsion, steroids, azathioprine and mycophenolate mofetil, other concomitant ...
Fertility, pregnancy and lactation
Simulect is contraindicated in pregnancy and lactation (see section 4.3). Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation and the suckling neonate ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
Basiliximab has been tested in four randomised, double-blind, placebo-controlled studies in renal transplant recipients as an induction agent in combination with the following immunosuppressive regimens: ...
Overdose
In clinical studies basiliximab has been administered to humans in single doses of up to 60 mg and multiple doses of up to 150 mg over 24 days with no acute undesirable effects. For information on preclinical ...
Pharmacodynamic properties
Pharmacotherapeutic group: Interleukin inhibitors ATC code: L04AC02 Mechanism of action Basiliximab is a murine/human chimeric monoclonal antibody (IgG1κ) that is directed against the interleukin-2 receptor ...
Pharmacokinetic properties
Adults Single-dose and multiple-dose pharmacokinetic studies have been conducted in adult patients undergoing kidney transplantation. Cumulative doses ranged from 20 mg up to 60 mg. Peak serum concentration ...
Preclinical safety data
No toxicity was observed when rhesus monkeys received intravenous doses of either up to 5 mg/kg basiliximab twice weekly for 4 weeks followed by an 8-week withdrawal period or 24 mg/kg basiliximab weekly ...
List of excipients
Powder Potassium dihydrogen phosphate Disodium phosphate, anhydrous Sodium chloride Sucrose Mannitol (E421) Glycine Solvent Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Powder: 3 years. Chemical and physical stability of the reconstituted solution is demonstrated for 24 hours at 2°C 8°C or for 4 hours at room temperature (see section 6.6).
Special precautions for storage
Store and transport refrigerated (2°C 8°C).
Nature and contents of container
Simulect powder Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 10 mg / 20 mg basiliximab ...
Special precautions for disposal and other handling
Simulect 10 mg powder and solvent for solution for injection or infusion Reconstitution: To prepare the solution for infusion or injection, take 2.5 ml of water for injections out of the accompanying 5 ...
Marketing authorization holder
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom
Marketing authorization number(s)
Simulect m10 mg powder and solvent for solution for injection or infusion: EU/1/98/084/002 Simulect 20 mg powder and solvent for solution for injection or infusion: EU/1/98/084/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 09/10/1998 Date of latest renewal: 09/10/2008
Date of revision of the text
14/12/2011