COSENTYX Solution for injection in pre-filled pen (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Cosentyx 150 mg solution for injection in pre-filled pen.
Qualitative and quantitative composition
Each pre-filled pen contains 150 mg secukinumab in 1 ml. Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see ...
Pharmaceutical form
Solution for injection in pre-filled pen (SensoReady pen). The solution is clear and colourless to slightly yellow.
Therapeutic indications
Plaque psoriasis Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Cosentyx, alone or in combination ...
Posology and method of administration
Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated. Posology Plaque psoriasis The recommended ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important, active infection, e.g. active tuberculosis (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 Secukinumab has the ...
Interaction with other medicinal products and other forms of interaction
Live vaccines should not be given concurrently with secukinumab (see also section 4.4). In a study in subjects with plaque psoriasis, no interaction was observed between secukinumab and midazolam (CYP3A4 ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use an effective method of contraception during treatment and for at least 20 weeks after treatment. Pregnancy There are no adequate ...
Effects on ability to drive and use machines
Cosentyx has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most frequently reported adverse drug reactions (ADRs) are upper respiratory tract infections (most frequently nasopharyngitis, rhinitis). Tabulated list of adverse reactions ...
Overdose
Doses up to 30 mg/kg (approximately 2000 to 3000 mg) have been administered intravenously in clinical studies without dose-limiting toxicity. In the event of overdose, it is recommended that the patient ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors ATC code: L04AC10 Mechanism of action Secukinumab is a fully human IgG1/κ monoclonal antibody that selectively binds to and neutralises ...
Pharmacokinetic properties
Most pharmacokinetics properties observed in patients with plaque psoriasis, psoriatic arthritis and ankylosing spondylitis were similar. Absorption Following a single subcutaneous dose of 300 mg as a ...
Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose and reproductive toxicity, or tissue cross-reactivity. Animal studies have not ...
List of excipients
Trehalose dihydrate Histidine Histidine hydrochloride monohydrate Methionine 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: 18 months. If necessary, Cosentyx may be stored unrefrigerated for a single period of up to 4 days at room temperature, not above 30°C.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store the pens in the original package in order to protect from light.
Nature and contents of container
Cosentyx is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label. The pre-filled syringe inside the pen is a 1 ml glass syringe with a silicone-coated ...
Special precautions for disposal and other handling
Cosentyx 150 mg solution for injection is supplied in a single-use pre-filled pen for individual use. The pen should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/14/980/004 EU/1/14/980/005 EU/1/14/980/007
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 January 2015 Date of latest renewal: 03 September 2019
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