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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Ilaris 150mg powder for solution for injection (2011)

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

Ilaris 150 mg powder for solution for injection.

Qualitative and quantitative composition

One vial contains 150 mg of canakinumab*. After reconstitution, each ml of solution contains 150 mg canakinumab. ...

Pharmaceutical form

Powder for solution for injection. The powder is white.

Therapeutic indications

Ilaris is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents ...

Posology and method of administration

Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Active, severe infections (see ...

Special warnings and precautions for use

Serious infections Ilaris may be associated with an increased incidence of serious infections. Therefore ...

Interaction with other medicinal products and other forms of interaction

Interactions between Ilaris and other medicinal products have not been investigated in formal studies. ...

Fertility pregnancy and lactation

Pregnancy There is a limited amount of data from the use of canakinumab in pregnant women. Animal studies ...

Effects on ability to drive and use machines

The ability to drive and operate machines may be impaired by some symptoms associated with CAPS. Patients ...

Undesirable effects

Summary of the safety profile Approximately 830 subjects have been treated with Ilaris in blinded and ...

Overdose

No case of overdose has been reported. In case of overdose, it is recommended for the patient to be monitored ...

Pharmacodynamic properties

Pharmacotherapeutic group: Interleukin inhibitors ATC code: L04AC08 This medicinal product has been authorised ...

Pharmacokinetic properties

The peak serum canakinumab concentration (C~max~) occurred approximately 7 days following single subcutaneous ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on cross-reactivity, repeated dose, immunotoxicity, ...

List of excipients

Sucrose Histidine Histidine hydrochloride monohydrate Polysorbate 80

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...

Shelf life

36 months After reconstitution, from a microbiological point of view, the product should be used immediately. ...

Special precautions for storage

Store in a refrigerator (2°C 8°C). Do not freeze. Store in the original package in order to protect ...

Nature and contents of container

150 mg of powder for solution for injection in a vial (type I glass) with a stopper (coated chlorobutyl ...

Special precautions for disposal and other handling

Instructions for reconstitution Using aseptic technique, reconstitute each vial of Ilaris at room temperature ...

Marketing authorization holder

Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom

Marketing authorization number(s)

EU/1/09/564/001-002

Date of first authorization / renewal of the authorization

23.10.2009

Date of revision of the text

16.09.2011
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.