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BIMZELX Solution for injection (2021)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Bimzelx 160 mg solution for injection in pre-filled syringe. Bimzelx 160 mg solution for injection in pre-filled pen.

2. Qualitative and quantitative composition

<u>Bimzelx 160 mg solution for injection in pre-filled syringe:</u> Each pre-filled syringe contains 160 mg of bimekizumab in 1 mL. <u>Bimzelx 160 mg solution for injection in pre-filled pen:</u> Each ...

3. Pharmaceutical form

Solution for injection (injection). The solution is clear to slightly opalescent and pale brownish-yellow.

4.1. Therapeutic indications

Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

4.2. Posology and method of administration

Bimzelx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis. Posology The recommended dose for adult patients with plaque ...

4.3. 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).

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 Bimekizumab may increase ...

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. There is no direct evidence for the role of IL-17A or IL-17F in the expression of CYP450 enzymes. The formation of some CYP450 enzymes is suppressed by increased ...

4.6. 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 17 weeks after treatment. Pregnancy There is a limited ...

4.7. Effects on ability to drive and use machines

Bimzelx has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile The most frequently reported adverse reactions were upper respiratory tract infections (14.5%) (most frequently nasopharyngitis) and oral candidiasis (7.3%). Tabulated list ...

4.9. Overdose

Single doses of 640 mg intravenously or 640 mg subcutaneously, followed by 320 mg subcutaneously every two weeks for five doses have been administered in clinical studies without dose-limiting toxicity. ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Immunosuppressants, interleukin inhibitors <b>ATC code:</b> L04AC21 Mechanism of action Bimekizumab is a humanised IgG1/κ monoclonal antibody that selectively binds with ...

5.2. Pharmacokinetic properties

Absorption Based on population pharmacokinetic analysis, following a single subcutaneous dose of 320 mg in plaque psoriasis patients, bimekizumab reached a median (2.5th and 97.5th percentile) peak plasma ...

5.3. Preclinical safety data

Non-clinical data revealed no special hazard for humans based on tissue cross-reactivity testing, repeat-dose toxicity studies (including safety pharmacology endpoints and assessment of fertilityrelated ...

6.1. List of excipients

Glycine Sodium acetate trihydrate Glacial acetic acid Polysorbate 80 Water for injections

6.2. Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

<u>Bimzelx 160 mg solution for injection in pre-filled syringe:</u> Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. The ...

6.5. Nature and contents of container

<u>Bimzelx 160 mg solution for injection in pre-filled syringe:</u> One mL pre-filled syringe (type I glass) with a fluoropolymer-laminated bromobutyl rubber stopper, staked 27G, ½" thin wall needle, and ...

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium

8. Marketing authorization number(s)

<u>Bimzelx 160 mg solution for injection in pre-filled syringe:</u> EU/1/21/1575/001 EU/1/21/1575/002 EU/1/21/1575/003 EU/1/21/1575/004 <u>Bimzelx 160 mg solution for injection in pre-filled pen:</u> ...

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