SKYRIZI 75 mg / 150 mg Solution for injection (2024)

Βιβλιογραφική αναφορά

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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 ...

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 ...

Therapeutic indications

Plaque psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Skyrizi, alone or in combination with ...

Posology and method of administration

This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Skyrizi is indicated. Posology The recommended ...

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. Interactions between risankizumab and inhibitors, inducers, or substrates of medicinal product metabolising enzymes ...

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 (13.0% in psoriasis). Tabulated list of adverse reactions Adverse reactions for risankizumab ...

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 ...

Pharmacokinetic properties

The pharmacokinetics of risankizumab was similar between subjects with plaque psoriasis and subjects with psoriatic arthritis. Absorption Risankizumab exhibited linear pharmacokinetics with dose-proportional ...

Preclinical safety data

Nonclinical data revealed no special hazard for humans based on repeat-dose toxicity studies including safety pharmacology evaluations, and an enhanced pre- and post-natal developmental toxicity study ...

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 ...

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 pen or the pre-filled syringe(s) in the outer carton in order to protect from light. Skyrizi 150 mg pre-filled pen or pre-filled syringe ...

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 ...

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 ...

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 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 26 April 2019 Date of latest renewal: 5 January 2024

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