ENBREL Powder for solution for injection (2023)

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Περιεχόμενα

Name of the medicinal product

Enbrel 25 mg powder for solution for injection.

Qualitative and quantitative composition

Each vial contains 25 mg of etanercept. Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression ...

Pharmaceutical form

Powder for solution for injection (powder for injection). The powder is white.

Therapeutic indications

Rheumatoid arthritis Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic ...

Posology and method of administration

Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Sepsis or risk of sepsis. Treatment with Enbrel should not be initiated in patients with active infections, including ...

Special warnings and precautions for use

In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file. Infections ...

Interaction with other medicinal products and other forms of interaction

Concurrent treatment with anakinra Adult patients treated with Enbrel and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either Enbrel or anakinra ...

Pregnancy and lactation

Women of childbearing potential Women of childbearing potential should consider the use of appropriate contraception to avoid becoming pregnant during Enbrel therapy and for three weeks after discontinuation ...

Effects on ability to drive and use machines

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

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such ...

Overdose

No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients. The highest dose level evaluated has been an intravenous loading dose of 32 mg/m² followed by subcutaneous ...

Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors ATC code: L04AB01 Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process ...

Pharmacokinetic properties

Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products, as well as the parent compound. Absorption Etanercept ...

Preclinical safety data

In the toxicological studies with Enbrel, no dose-limiting or target organ toxicity was evident. Enbrel was considered to be non-genotoxic from a battery of in vitro and in vivo studies. ...

List of excipients

Powder: Mannitol (E421) Sucrose Trometamol

Incompatibilities

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

Shelf life

Shelf life 4 years. Chemical and physical in-use stability has been demonstrated for 6 hours at temperatures of up to 25°C after reconstitution. From a microbiological point of view, the reconstituted ...

Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze. Enbrel may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. ...

Nature and contents of container

Clear glass vial (2 ml, type I glass) with rubber stoppers, aluminium seals, and flip-off plastic caps. Cartons contain 4 vials of Enbrel with 8 alcohol swabs.

Special precautions for disposal and other handling

Instructions for use and handling Enbrel is reconstituted with 1 ml water for injections before use and administered by subcutaneous injection. Enbrel contains no antibacterial preservative, and therefore, ...

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization number(s)

EU/1/99/126/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 03 February 2000 Date of last renewal: 26 November 2009

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