ENBREL SPC PDF

Enbrel® (etanercept) is a prescription medicine used to treat five chronic diseases, including moderate to severe rheumatoid arthritis. These highlights do not include all the information needed to use Enbrel safely and effectively. See full prescribing information for Enbrel. Enbrel® (etanercept). What is Enbrel (etanercept) and what is it used for? of Product Characteristics ( SPC) for Enbrel these can be found at the electronic Medicines Compendium.

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Hydrophobic interaction chromatography HIC is performed to assess the purity of etanercept and the related product species present. No study has been performed in patients with psoriatic arthritis using the 50 mg once-weekly dosing regimen. No studies on the effects on the ability to drive and use machines have been performed.

Hypersensitivity to the active substance or to any of the excipients listed in section 6. The clinical significance of this is unknown. Merkel cell carcinoma see section 4. No enbrrl toxicities were observed during clinical trials of rheumatoid arthritis patients. Enbrel is administered by subcutaneous injection.

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 spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis. Similarly, the significant advantages for Enbrel monotherapy compared with methotrexate monotherapy were also observed after 24 months.

A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded. The clinical impact of this is unknown, however, infants may be at increased risk of infection. The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.

Tools and assistance Our support services can help make things easier. Residual analysis was used to check the validity of the linear models. Physicians should exercise caution when considering the use of Enbrel in patients with a history of recurring eenbrel chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes.

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Clear glass vial 4 ml, type I glass with rubber stoppers, aluminium seals, and flip-off plastic caps. Storage conditions for stability studies and approved shelf life in EU for etanercept DP presentations.

In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, dpc overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received Enbrel were observed compared with younger patients.

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Cold storage conditions are not fully compatible with many of the activities of modern lifestyle and many of these epc could potentially be mitigated if stability of enbrfl product could be demonstrated at temperatures encountered under ambient conditions. In this study, 53 patients received placebo, patients received 50 mg Enbrel once weekly and patients received 25 mg Enbrel twice weekly.

Improvements in health-related quality of life and physical function were also maintained through 2 years of therapy.

New infections or worsening of infections you already have; hepatitis B can become active if you already have had it; nervous system problemssuch as multiple sclerosis, seizures, or inflammation of the nerves of the eyes; blood problems some fatal ; new or worsening heart failure ; new or worsening psoriasis ; allergic reactions ; autoimmune reactionsincluding a lupus-like syndrome and autoimmune hepatitis.

Published online Jul Doses of 10 mg or 25 mg Enbrel or placebo were administered subcutaneously twice a week for 6 consecutive months. Wegener’s granulomatosis A placebo-controlled trial, in which 89 adult patients were treated with Enbrel in addition to standard therapy including cyclophosphamide or methotrexate, and glucocorticoids for a median duration of 25 months, has not shown Enbrel to be an effective treatment for Wegener’s granulomatosis.

Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available. See More See More. This site uses cookies.

This is not health insurance. Enbrel 50mg solution for injection in pre-filled syringe.

Enbrel 25 mg powder and solvent for solution for injection

Some parts of the site may not work properly if you choose not to accept cookies. Serum concentration profiles were similar to those seen in adult rheumatoid arthritis patients. The study evaluated adult patients with active rheumatoid arthritis who had failed therapy with at least one but no more than four disease-modifying antirheumatic drugs DMARDs. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.

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Enbrel 25 mg powder and solvent for solution for injection. J Manag Care Pharm. The presence of hepatic impairment should not require a change in dosage. In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency incidence enbtel of autoimmune hepatitis was 0.

No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel. We aimed to generate a comprehensive analytical data package from stability testing of key quality attributes, consistent with regulatory requirements, to determine whether the product profile of etanercept is maintained at ambient temperature.

Powder and solvent for solution for injection powder for injection. For storage conditions of the reconstituted medicinal product, see section 6. Test methods assessing key attributes of purity, quality, potency, and safety were performed over time, following storage of etanercept DP presentations under a range of conditions.

Double-Blind Clinical Responses at Week CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis see section 4.

Am J Health Syst Pharm. July Detailed information on ehbrel medicinal product is available on the website of the European Medicines Agency http: Enbrel should be used with caution in patients with a history of hepatitis C.

Consequently, Enbrel should not be used in patients for the treatment of alcoholic hepatitis.

In each of the JIA subtypes, the majority of patients met ACR Pedi 30 criteria and demonstrated clinical improvement in secondary endpoints such as number of tender joints and physician global assessment. Reports have included fatal and life-threatening infections and sepsis. The safety profile was consistent with that observed in other JIA studies.