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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Simulect 10mg and 20mg powder and solvent for solution for injection or infusion (2012)

Εκδότης

Εκδότης Novartis Pharmaceuticals UK Ltd
Διεύθυνση Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Simulect® 10 mg powder and solvent for solution for injection or infusion. Simulect® 20 mg powder and ...

Qualitative and quantitative composition

Each vial contains 10 or 20 mg basiliximab*. One ml of the reconstituted solution contains 4 mg basiliximab. ...

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 ...

Posology and method of administration

Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 6.1). Pregnancy and ...

Special warnings and precautions for use

Patients receiving Simulect must be managed in facilities equipped and staffed with adequate laboratory ...

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 ...

Fertility, pregnancy and lactation

Simulect is contraindicated in pregnancy and lactation (see section 4.3). Basiliximab has potentially ...

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 ...

Overdose

In clinical studies basiliximab has been administered to humans in single doses of up to 60 mg and multiple ...

Pharmacodynamic properties

Pharmacotherapeutic group: Interleukin inhibitors ATC code: L04AC02 Mechanism of action Basiliximab is ...

Pharmacokinetic properties

Adults Single-dose and multiple-dose pharmacokinetic studies have been conducted in adult patients undergoing ...

Preclinical safety data

No toxicity was observed when rhesus monkeys received intravenous doses of either up to 5 mg/kg basiliximab ...

List of excipients

Powder Potassium dihydrogen phosphate Disodium phosphate, anhydrous Sodium chloride Sucrose Mannitol ...

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

Powder: 3 years. Chemical and physical stability of the reconstituted solution is demonstrated for 24 ...

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 ...

Special precautions for disposal and other handling

Simulect 10 mg powder and solvent for solution for injection or infusion Reconstitution: To prepare the ...

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 ...

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
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.