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.

Author: Aragor Voodooramar
Country: Suriname
Language: English (Spanish)
Genre: Education
Published (Last): 13 January 2005
Pages: 388
PDF File Size: 5.52 Mb
ePub File Size: 12.12 Mb
ISBN: 324-2-21107-176-5
Downloads: 55196
Price: Free* [*Free Regsitration Required]
Uploader: Maujar

Patients with significant exposure to varicella virus should temporarily discontinue etanercept and be considered for prophylactic treatment with varicella zoster immune globulin. The types of major birth defects were consistent with those most commonly reported in the general population and no particular pattern of abnormalities was identified.

Treatment of active polyarticular-course juvenile chronic arthritis in children aged four to 17 years who have had an inadequate response fnbrel, or who have proved intolerant of, methotrexate. Perspective article Review article Research article. Enbrel can be given as monotherapy in case of intolerance to soc or when continued treatment with methotrexate is inappropriate.

Adjusted mean change from baseline was 3. The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus, and Histoplasma. Advances and Applications are provided here courtesy of Dove Press. Etanercept contains amino acids and has an apparent molecular weight of approximately kilodaltons. Plain language summary Why was the study conducted?

Manufacturing of recombinant therapeutic proteins in microbial systems. Stability studies were conducted on multiple batches manufactured at three commercial manufacturing sites. New onset cardiac failure congestive see section 4. Treatment with Enbrel should continue until remission is achieved, for up to 24 weeks.

Find a Medicine Results

This has the potential to provide greater flexibility for patients in managing their disease and in fulfilling their daily lives in terms of work, leisure, and travel. The results of this controlled trial were expressed in percentage improvement in rheumatoid arthritis using American College of Rheumatology ACR response criteria. The U cells were incubated at Significant advantages for Enbrel in combination with methotrexate compared with Enbrel monotherapy and methotrexate monotherapy were also observed after 24 months.

  DESCARGAR SEMIOLOGIA DE CEDIEL PDF

In an open-label, safety extension study, 58 paediatric patients from the above study from the age of 4 years at time of enrollment continued to receive Enbrel for up to 10 years.

Quality of life in psoriatic arthritis patients was assessed at every timepoint using the disability index of the HAQ. Last Updated 6 May Dimeric soluble receptors, such as etanercept, possess a higher affinity for TNF than monomeric receptors and are considerably more potent competitive inhibitors of TNF binding to its cellular receptors.

A higher rate of major birth defects was observed in an observational study comparing pregnancies exposed to etanercept during the first trimester, with pregnancies not exposed to etanercept or other TNF-antagonists adjusted odds ratio 2.

Enbrel injection

It is a competitive inhibitor of TNF binding to cell surface receptors. Worsening of hepatitis C There have been reports of worsening of hepatitis C in patients receiving Enbrel. Improvements in health-related quality of life and physical function were also maintained through 2 years of therapy.

Enhrel can have a role in structure, activity, signaling, clearance, and immunogenicity. Thus, the combined use of Enbrel and anakinra is not recommended see sections 4.

In the postmarketing setting, cases of leukaemia have been reported in patients treated with TNF-antagonists. There was some evidence to support a benefit of re-treatment with Enbrel in patients initially responding to treatment. This information is intended only for U.

Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breast-feeding or to discontinue Enbrel therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

  CATALOGO ASCASO PDF

There is insufficient evidence of the efficacy of Enbrsl in patients with enbrsl spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.

Search for a Medicine

One rheumatoid arthritis patient mistakenly self-administered 62 mg Enbrel subcutaneously twice weekly for 3 weeks without experiencing undesirable effects. 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.

No dose-limiting toxicities observed in trials. While neutropenic, one patient developed cellulitis that resolved after hospitalisation see sections 4.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. Skin and subcutaneous tissue disorders. One hundred and twenty-nine new malignancies of various types were observed in 4, rheumatoid arthritis patients treated in clinical trials with Enbrel for up to approximately 6 years, including patients treated with Enbrel in combination with methotrexate in the 2-year active-controlled study.

Continued therapy should be carefully reconsidered in a patient not responding within this time period. Worsening of symptoms of dermatomyositis. The clinical significance of this is unknown. In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency incidence proportion of autoimmune hepatitis was 0.

Interactions between etanercept and other drugs have not been evaluated in formal studies. Serious haematological, neurological and autoimmune reactions have also been reported.

July Detailed information on this medicinal product is available on the website of the European Medicines Agency http: Neurological disorders There have been rare reports of CNS demyelinating disorders in patients treated with Enbrel see section 4.

Author: admin