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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

Ilaris 150mg powder for solution for injection (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Novartis Pharmaceuticals UK Ltd
Διεύθυνση :
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Δωρεάν εγγραφή

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. * fully human monoclonal antibody produced in mouse hybridoma Sp2/0 cells by recombinant ...

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 and children aged 4 years and older with body weight above 15 kg, including: Muckle-Wells ...

Posology and method of administration

Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of CAPS. After proper training in the correct injection technique, patients may self-inject ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Active, severe infections (see section 4.4).

Special warnings and precautions for use

Serious infections Ilaris may be associated with an increased incidence of serious infections. Therefore patients should be monitored carefully for signs and symptoms of infections during and after treatment ...

Interaction with other medicinal products and other forms of interaction

Interactions between Ilaris and other medicinal products have not been investigated in formal studies. An increased incidence of serious infections has been associated with administration of another IL-1 ...

Fertility pregnancy and lactation

Pregnancy There is a limited amount of data from the use of canakinumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section ...

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 who experience vertigo during Ilaris treatment should wait for this to resolve completely before ...

Undesirable effects

Summary of the safety profile Approximately 830 subjects have been treated with Ilaris in blinded and open-label clinical trials in patients with CAPS, patients with other diseases, and healthy volunteers. ...

Overdose

No case of overdose has been reported. In case of overdose, it is recommended for the patient to be monitored for any signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted ...

Pharmacodynamic properties

Pharmacotherapeutic group: Interleukin inhibitors ATC code: L04AC08 This medicinal product has been authorised under Exceptional Circumstances. This means that due to the rarity of the disease it has not ...

Pharmacokinetic properties

The peak serum canakinumab concentration (C<sub>max</sub>) occurred approximately 7 days following single subcutaneous administration of 150 mg in adult CAPS patients. The mean terminal half-life was 26 ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on cross-reactivity, repeated dose, immunotoxicity, reproductive and juvenile toxicity studies performed with canakinumab or a murine anti-murine ...

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 products.

Shelf life

36 months After reconstitution, from a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility ...

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. For storage conditions of the reconstituted medicinal product, see section 6.3.

Nature and contents of container

150 mg of powder for solution for injection in a vial (type I glass) with a stopper (coated chlorobutyl rubber) and flip-off cap (aluminium). Packs containing 1 vial or multipacks containing 4 (4x1) vials. ...

Special precautions for disposal and other handling

Instructions for reconstitution Using aseptic technique, reconstitute each vial of Ilaris at room temperature by slowly injecting 1.0 ml water for injections with a 1 ml syringe and an 18 G x 2 inch (50 ...

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