ILARIS Powder for solution for injection (2020)
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Περιεχόμενα
Name of the medicinal product
Ilaris 150 mg/ml solution for injection.
Qualitative and quantitative composition
One vial contains 150 mg of canakinumab*. Each ml of solution contains 150 mg canakinumab. * human monoclonal antibody produced in mouse myeloma Sp2/0 cells by recombinant DNA technology For the full list ...
Pharmaceutical form
Solution for injection (injection). The solution is clear to opalescent and colourless to slightly brownish yellow.
Therapeutic indications
Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: Cryopyrin-associated ...
Posology and method of administration
For CAPS, TRAPS, HIDS/MKD, FMF and Stills disease, the treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of the relevant indication. For ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active, severe infections (see section 4.4).
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Canakinumab is associated ...
Interaction with other medicinal products and other forms of interaction
Interactions between canakinumab and other medicinal products have not been investigated in formal studies. An increased incidence of serious infections has been associated with administration of another ...
Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in males and females Women should use effective contraceptives during treatment with canakinumab and for up to 3 months after the last dose. Pregnancy There ...
Effects on ability to drive and use machines
Ilaris has minor influence on the ability to drive and use machines. Treatment with Ilaris may result in dizziness/vertigo or asthenia (see section 4.8). Patients who experience such symptoms during Ilaris ...
Undesirable effects
Summary of the safety profile The most frequent adverse drug reactions were infections predominantly of the upper respiratory tract. No impact on the type or frequency of adverse drug reactions was seen ...
Overdose
Reported experience with overdose is limited. In early clinical trials, patients and healthy volunteers received doses as high as 10 mg/kg, administered intravenously or subcutaneously, without evidence ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors ATC code: L04AC08 Mechanism of action Canakinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ ...
Pharmacokinetic properties
CAPS Absorption 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 ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of cross-reactivity, repeated dose toxicity, immunotoxicity, toxicity to reproduce and development. Formal carcinogenicity ...
List of excipients
Mannitol Histidine Histidine hydrochloride monohydrate Polysorbate 80 Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years. From a microbiological point of view, the product should be used immediately after first opening.
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.
Nature and contents of container
Solution for injection in a vial (type I glass) with a stopper (laminated chlorobutyl rubber) and flip-off cap (aluminium). Packs containing 1 vial. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Ilaris 150 mg/ml solution for injection is supplied in a single-use vial for individual use. Instructions for administration Allow the vial to warm to room temperature before injection. The solution should ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/09/564/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 October 2009 Date of latest renewal: 06 June 2019
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