CIMZIA PACKAGE INSERT PDF

August 5, 2020 0 By admin

CIMZIA is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis; CIMZIA is indicated for the treatment of . drug interactions. o Cimzia is indicated for reducing signs and symptoms of Crohn’s disease and modifying anti-rheumatic drug (DMARD). 3. Cimzia [package insert]. Smyrna. Medscape – Rheumatoid arthritis and Crohn disease dosing for Cimzia ( certolizumab pegol), frequency-based adverse effects, comprehensive interactions.

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Cimzia is mostly used for conditions that are severe, moderately severe or getting worse, or when patients cannot use other treatments.

For detailed information on the use of Cimzia in all conditions, see the summary of product characteristics. Cimzia can only be obtained with a prescription and treatment should only be started by a specialist doctor who has experience in diagnosing and treating the diseases that Cimzia is used to treat. Cimzia is available as pre-filled syringes, prefilled pens pafkage dose-dispenser cartridge. It is given by injection under the skin, usually in the thigh or abdomen tummy.

Treatment starts with a mg dose given as two injections, followed by a further mg dose two and four weeks later.

After this, depending on the condition being treated, patients should continue with mg or mg, given as one or two injections every two or four weeks. After training, patients may inject Cimzia themselves if their doctor agrees.

A monoclonal antibody is a protein that has been designed to recognise and attach to a specific structure in the body. Certolizumab pegol has been designed to attach to a messenger protein in the body called tumour necrosis factor alpha TNF-alpha. This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Cimzia is used for. By blocking TNF-alpha, certolizumab pegol reduces inflammation and other symptoms of the diseases.

Pegylation decreases the rate at which the substance is removed from the body and allows the medicine to be given less often. Nine main studies involving over 3, patients have found Cimzia effective for reducing symptoms of inflammatory conditions.

The studies included adults with active rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and moderate to severe plaque psoriasis:. Similar results were seen in a study with patients who had not adequately responded to other medicines such as methotrexate. However, the dose of Cimzia used in this pavkage was higher than the usual dose. In patients with active rheumatoid arthritis who had never received DMARDs, treatment with Cimzia led to sustained remission no detectable disease activity after 52 weeks of treatment.

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A third study compared Cimzia with placebo as well as another medicine called etanercept. The most common side effects with Cimzia affecting up to 1 in 10 people are bacterial infections including abscesses cavities containing pusviral infections including herpes, papillomavirus and influenzaeosinophilic disorders disorders of eosinophils, a type of white blood cellleucopenia low white blood cell countsnausea feeling sickheadaches including migrainesensory abnormalities such as numbness, tingling and burning sensationhigh blood pressure, hepatitis liver inflammation including increased levels of liver enzymes, rash, fever, pain, weakness, itching and reactions at the injection site.

For the full list of side effects of Cimzia, see the package leaflet. Cimzia must not be used in patients with active tuberculosis, other severe infections, or moderate to severe heart failure inability of packgae heart to pump enough blood around the body.

For the full list of restrictions, see the package leaflet. 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.

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As for all medicines, data on the use of Cimzia are continuously monitored. Side effects reported with Cimzia are carefully evaluated and any necessary action taken to protect patients. More detail is available in the summary of product characteristics. Cimzia has been shown to reduce the rate of progression of joint damage as cimzoa by X ray and packahe improve physical function, when given in combination with MTX.

Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:. Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs NSAIDs. Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate.

Cimzia can be given as packagge in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Skip to main content.

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Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Table of contents Overview Authorisation details Product information Assessment history. 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: Cimzia contains the active substance certolizumab pegol.

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Dosing Information | CIMZIA® (certolizumab pegol)

For more information see the package leaflet or contact your doctor or pharmacist. The studies included adults with active rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and moderate to insetr plaque psoriasis: For active rheumatoid arthritis that had not improved adequately with disease-modifying antirheumatic drug DMARD treatment, two main studies found Cimzia effective when used with methotrexate when compared with placebo dummy treatment.

Also, X-rays showed that joint damage worsened to a lesser extent in patients who received Cimzia. In the treatment of moderate to severe plaque psoriasis, Cimzia was compared with placebo in two main studies. Treatment with Cimzia mg every two weeks in the two studies led to Patients on Cimzia mg every two weeks led to Cimzia received a marketing authorisation valid throughout the EU on 1 October Product details Name Cimzia.

You are therefore advised to be selective about which sections or pages you wish to inaert. Rheumatoid inssrt Cimzia, in combination with methotrexate MTXis indicated for: Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: Ankylosing spondylitis AS Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs NSAIDs.

Psoriatic arthritis Cimzia, in combination with MTX, is indicated for the cimziz of active psoriatic arthritis in adults when onsert response to previous DMARD therapy has been inadequate. Changes since initial authorisation of medicine List item. Initial marketing-authorisation documents List item.

How useful was this page? Leave this field blank. International non-proprietary name INN or common name. Anatomical therapeutic chemical ATC code. Date of issue of marketing authorisation valid pxckage the European Union.