KINERET Solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
Qualitative and quantitative composition
Each graduated pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ml). * Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in Escherichia coli cells by recombinant DNA technology. ...
Pharmaceutical form
Solution for injection (injection). Clear, colourless-to-white solution for injection that may contain some product-related translucentto-white amorphous particles.
Therapeutic indications
Rheumatoid Arthritis (RA) Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone. Cryopyrin-Associated ...
Posology and method of administration
Kineret treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of RA, CAPS and Stills disease, respectively. Posology RA: Adults The recommended ...
Contraindications
Hypersensitivity to the active substance or to to any of the excipients listed in section 6.1 or to E. coli derived proteins. Kineret treatment must not be initiated in patients with neutropenia (ANC <1.5 ...
Special warnings and precautions for use
Allergic reactions Allergic reactions, including anaphylactic reactions and angioedema have been reported uncommonly. The majority of these reactions were maculopapular or urticarial rashes. If a severe ...
Interaction with other medicinal products and other forms of interaction
Interactions between Kineret and other medicinal products have not been investigated in formal studies. In clinical trials, interactions between Kineret and other medicinal products (including nonsteroidal ...
Pregnancy and lactation
Pregnancy There are limited amount of data from the use of anakinra 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
Not relevant.
Undesirable effects
Summary of the safety profile In placebo-controlled studies in RA patients, the most frequently reported adverse reactions with Kineret were injection site reactions (ISRs), which were mild to moderate ...
Overdose
No dose-limiting toxicities were observed during clinical studies. In studies of sepsis, 1,015 patients received Kineret at doses up to 2 mg/kg/hour i.v. (~35 times the recommended dose in RA) over a 72 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors ATC code: L04AC03 Mechanism of action Anakinra neutralises the biologic activity of interleukin-1α (IL-1α) and interleukin-1β (IL-1β) ...
Pharmacokinetic properties
The absolute bioavailability of anakinra after a 70 mg subcutaneous bolus injection in healthy subjects (n=11) is 95%. The absorption process is the rate-limiting factor for the disappearance of anakinra ...
Preclinical safety data
Anakinra had no observed effect on the fertility, early development, embryo-foetal development, or peri- and postnatal development in the rat at doses up to 100 times the human dose (2 mg/kg/day). No effects ...
List of excipients
Citric acid, anhydrous Sodium chloride Disodium edetate dihydrate Polysorbate 80 Sodium hydroxide Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original container in order to protect from light. For the purpose of ambulatory use, Kineret may be removed from the refrigerator for 12 ...
Nature and contents of container
0.67 ml of solution for injection in a graduated pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl rubber) and 29 gauge needle. The pre-filled syringe has an outer rigid plastic needle ...
Special precautions for disposal and other handling
Kineret is a sterile unpreserved solution. For single use only. Do not shake. Allow the pre-filled syringe to reach room temperature before injecting. Before administration, visually inspect the solution ...
Marketing authorization holder
Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Marketing authorization number(s)
EU/1/02/203/005 – 1-pack EU/1/02/203/006 – 7-pack EU/1/02/203/007 – 28-pack
Date of first authorization / renewal of the authorization
Date of first authorisation: 8 March 2002 Date of latest renewal: 20 March 2007
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