SPC, UK: Ilaris 150mg powder for solution for injection
||Novartis Pharmaceuticals UK Ltd
||Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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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. ...
Powder for solution for injection. The powder is white.
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 ...
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 ...
Summary of the safety profile Approximately 830 subjects have been treated with Ilaris in blinded and ...
No case of overdose has been reported. In case of overdose, it is recommended for the patient to be monitored ...
Pharmacotherapeutic group: Interleukin inhibitors ATC code: L04AC08 This medicinal product has been authorised ...
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
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...
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)
Date of first authorization / renewal of the authorization
Date of revision of the text
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.