CIMZIA PI PDF

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PI & CMI Trade Names and Active Ingredients containing certolizumab. 2 Documents cimzia, PI, Certolizumab pegol. Cimzia, CMI, Certolizumab pegol. Cimzia mg solution for injection in pre-filled syringe. 2. QUALITATIVE The recommended starting dose of Cimzia for adult patients is mg (given as 2. An overview of Cimzia and why it is authorised in the EU. Cimzia is a medicine that is used in adults to treat the following diseases: active rheumatoid arthritis (a .

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Concomitant treatment with methotrexate, corticosteroids, nonsteroidal anti-inflammatory drugs NSAIDs and cimzi showed no effect on the pharmacokinetics of certolizumab pegol based on a population pharmacokinetics analysis.

In vitro functional studies of human ckmzia macrophages indicated all functions tested were retained. In both clinical trials, Cimzia-treated patients reported significantly greater improvements in the SF Physical and Mental Component Summaries and all domain scores. By blocking TNF-alpha, certolizumab pegol reduces inflammation and other symptoms of the diseases. Dizziness including vertigo, vision disorder and fatigue may occur following administration of Cimzia see section 4.

Reproductive system and breast disorders. Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia.

cmzia It does not induce apoptosis in vitro in human peripheral blood-derived monocytes or lymphocytes, or neutrophil degranulation. Of the patients initially randomised to active treatment in RA-I, completed 52 weeks of placebo-controlled treatment and entered the open-label extension study. Specific clinical trials have not been performed to assess the effect of renal impairment on the pharmacokinetics of certolizumab pegol or its PEG fraction.

Similar results were achieved in both the ankylosing spondylitis and non-radiographic axial spondyloarthritis subpopulations.

Among PASI75 responders at Week 16 who received Cimzia mg every icmzia weeks and were re-randomized to either Cimzia mg every 4 weeks, Cimzia mg every 2 weeks, or placebo, there was also a higher percentage of PASI 75 responders at Week 48 in the Cimzia groups as compared to placebo However, the available clinical experience is too limited to, with a reasonable certainty, conclude that there is no increased risk associated with Cimzia administration during pregnancy.

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Cimzzia email a medicine you must sign up and log in. For patients who test cmizia for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.

The primary endpoint of the study was the ACR 20 responder rate at week In a clinical trial with another TNF-antagonist, worsening congestive heart cimzja and increased mortality due to congestive heart failure have been observed. The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 9. BCG vaccine ppi, unless the benefit of the vaccination clearly outweighs the theoretical risk of administration of live or live-attenuated vaccines to the infants.

At week 16, patients randomized to Cimzia who achieved a PASI 50 response continued to receive Cimzia up to Week 48 at the same randomized dose. A risk for development of hepatosplenic T-cell lymphoma in patients treated with Cimzia cannot be excluded. Interference with certain coagulation assays has been detected in patients treated with Cimzia. Patients were treated with a loading dose of Cimzia mg at Weeks 0, 2 and 4 for both treatment arms or placebo followed by either mg of Cimzia every 2 weeks or mg of Cimzia every 4 weeks or placebo.

For the full list of restrictions, see the package leaflet. Serious infections, including sepsis and tuberculosis including miliary, disseminated and extrapulmonary diseaseand opportunistic infections e.

The studies included adults clmzia active rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and moderate to severe plaque psoriasis: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cimzia have been included in the summary of product characteristics and the package leaflet.

For the above indications, available data suggest that clinical response is usually achieved within 12 weeks of treatment. The combination of certolizumab pegol and anakinra or abatacept is not recommended cimzua section 4.

Cimzia 200 mg solution for injection in pre-filled syringe

Patients with rheumatoid arthritis may not manifest typical symptoms of infection, including fever, due to their cimzoa and concomitant medicinal products. Summary of the safety profile Rheumatoid arthritis Cimzia was studied in 4, patients with rheumatoid arthritis in controlled and open label trials for up to 92 months. Reports of pancytopaenia, including aplastic anaemia, have been rare with TNF-antagonists. Nine main studies involving over 3, patients cimaia found Cimzia effective for reducing symptoms of inflammatory conditions.

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The pH of the solution is approximately 4. Sign Up Log In Cancel.

The percentage of the maternal certolizumab pegol dose reaching an infant during a 24 hour period was estimated to 0. Renal and hepatic impairment Cimzia has not been studied in these patient populations. Cimzia received a marketing authorisation valid throughout the EU on 1 October Immunosuppression Since tumour necrosis factor TNF mediates inflammation and modulates cellular immune responses, the possibility exists for TNF-antagonists, including Cimzia, to cause immunosupression, affecting host defences against infections and malignancies.

Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks. A third study compared Cimzia with placebo as well as cmzia medicine called etanercept.

Patients receiving Cimzia and concomitant methotrexate had a lower humoral response compared with patients receiving Cimzia alone.

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Among patients remaining in the study, ACR 20, 50 and 70 response rates were maintained through Week Leave this field blank. In the placebo-controlled clinical trials, there were more new cases of serious infection in the Cimzia treatment groups 0. Major clinical response is defined as achieving ACR 70 response cimziq every assessment over a continuous 6-month period Wald p-values are quoted for the comparison of treatments using logistic cimzai with factors for treatment and region.

Table of contents Overview Authorisation details Product information Assessment history.