SKYRIZI Solution for injection (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Skyrizi 150 mg solution for injection in pre-filled pen. Skyrizi 150 mg solution for injection in pre-filled syringe. Skyrizi 75 mg solution for injection in pre-filled syringe.
Qualitative and quantitative composition
Skyrizi 150 mg solution for injection in pre-filled pen: Each pre-filled pen contains 150 mg risankizumab in 1 mL solution. Skyrizi 150 mg solution for injection in pre-filled syringe: Each pre-filled ...
Pharmaceutical form
Solution for injection (injection). Skyrizi 150 mg solution for injection in pre-filled pen and in pre-filled syringe: The solution is colourless to yellow and clear to slightly opalescent. Skyrizi 75 ...
Therapeutic indications
Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Posology and method of administration
Skyrizi is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis. Posology Skyrizi 150 mg solution for injection in pre-filled pen and ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important active infections (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 Risankizumab may increase ...
Interaction with other medicinal products and other forms of interaction
Risankizumab is not expected to undergo metabolism by hepatic enzymes or renal elimination. Drug interactions between risankizumab and inhibitors, inducers, or substrates of drug metabolising enzymes are ...
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 21 weeks after treatment. Pregnancy There are no or limited ...
Effects on ability to drive and use machines
Risankizumab 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 reactions were upper respiratory infections, which occurred in 13% of patients. Tabulated list of adverse reactions Adverse reactions ...
Overdose
In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors ATC code: L04AC18 Mechanism of action Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds ...
Pharmacokinetic properties
Absorption Risankizumab exhibited linear pharmacokinetics with dose-proportional increase in exposure across dose ranges of 18 to 300 mg and 0.25 to 1 mg/kg administered subcutaneously, and 200 to 1,200 ...
Preclinical safety data
Nonclinical data revealed no special hazard for humans based on repeat-dose toxicity studies including safety pharmacology evaluations, and a reproductive and developmental toxicity study in cynomolgus ...
List of excipients
Skyrizi 150 mg solution for injection in pre-filled pen and pre-filled syringe: Sodium acetate trihydrate Acetic acid Trehalose dihydrate Polysorbate 20 Water for injections Skyrizi 75 mg solution for ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
2 years.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringes in the outer carton in order to protect from light.
Nature and contents of container
Skyrizi 150 mg solution for injection in pre-filled pen: Pre-filled glass syringe assembled in a pre-filled pen with an automatic needle sleeve. Skyrizi 150 mg solution for injection in pre-filled syringe: ...
Special precautions for disposal and other handling
Skyrizi 150 mg solution for injection in pre-filled pen Before injecting, patients should remove the carton from the refrigerator and allow to reach room temperature out of direct sunlight (30 to 90 minutes) ...
Marketing authorization holder
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
Marketing authorization number(s)
Skyrizi 150 mg solution for injection in pre-filled pen: EU/1/19/1361/002 Skyrizi 150 mg solution for injection in pre-filled syringe: EU/1/19/1361/003 Skyrizi 75 mg solution for injection in pre-filled ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 April 2019
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