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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cmizia Cimzia, in combination with Cimia, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate.
The studies included adults with active rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and moderate to severe plaque psoriasis: Suitable sites for injection would include the thigh or abdomen. The week double-blind, placebo-controlled treatment period of the study was followed by a week dose-blind treatment period, and a week open-label treatment period. 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.
For the above indications, available data suggest that clinical response is usually achieved within 12 weeks of treatment. Efficacy and safety of Cimzia in cimzla with PsA whose predominant symptoms were sacroiliitis or axial spondyloarthritis have not been separately analysed.
In a clinical trial with another TNF-antagonist, worsening congestive heart failure and increased mortality due to congestive heart failure have been observed. Major clinical response is defined as achieving ACR 70 response at every assessment over a continuous 6-month period Wald p-values are quoted for the comparison of treatments using logistic regression with po for treatment and region.
Cimzia must not be used in patients with active tuberculosis, other severe infections, or moderate to severe heart failure inability of the heart to pump enough blood around the body.
If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia and in accordance with local recommendations.
Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: The pre-filled syringe with needle guard should only be used by healthcare professionals.
Appropriate screening tests, e. 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. Cimzia mg solution for injection in pre-filled syringe. Before initiation of therapy with Cimzia, all patients must be evaluated for both active or inactive latent tuberculosis infection.
Co-administration of Cimzia with methotrexate had no significant effect on the pharmacokinetics of methotrexate. Find out more here. No data are available. Enter medicine name or company Start typing to retrieve search suggestions.
For more information see the package leaflet or contact your doctor or pharmacist. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia. Patients treated with Cimzia may receive vaccinations, except for live vaccines. 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 | European Medicines Agency
Severe infections and neutropaenia were reported in clinical trials with concurrent use of anakinra an interleukin-1 antagonist or abatacept a CD28 modulator and another TNF-antagonist, etanercept, with no added benefit compared to TNF-antagonist therapy alone.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. These data are reasonably in agreement with observed data. Response rates and p-values based on a logistic regression model.
Cimzia 200 mg solution for injection in pre-filled syringe
General disorders and administration site conditions. Cimzia has not been studied specifically in a lupus population see section 4.
A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded. In cases of overdose, it is recommended that patients are monitored closely for any adverse reactions or effect, and appropriate symptomatic treatment initiated immediately.
No mutagenic or clastogenic effects were demonstrated in preclinical studies. For details on therapeutic effects, see section 5. A patient who requires surgery while on Cimzia should be closely monitored for infections, and appropriate actions should be taken.
The axial spondyloarthritis overall population included subpopulations with and without non-radiographic axial spondyloarthritis [nr-axSpA] radiographic evidence for ankylosing spondylitis AS. 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. Axial spondyloarthritis Cimzzia was studied in patients with active axial spondyloarthritis cimsia the AS clinical study for up to 4 years, which includes a week placebo-controlled phase followed by cumzia week dose-blind period and a week open-label treatment period.
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There is limited safety experience with surgical procedures in patients treated with Cimzia. Reproductive system and breast disorders.
Cimaia the placebo-controlled studies, patients receiving Cimzia had an approximately 4 times greater duration of exposure compared with the placebo group. Contact with natural rubber latex may cause severe allergic reactions in individuals sensitive to latex. Treatment with Cimzia must not be initiated in patients with a clinically important active infection, including chronic or localised infections, until the infection is controlled see section 4.
During the week follow-up, no treatment effects of certolizumab pegol dimzia seen on semen quality parameters compared to placebo. How useful was this page? Infections Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia. Cimzia was studied in patients with psoriasis in controlled and open-label studies for up to 18 months.
The needle shield is styrene butadiene rubber which contains a derivative of natural rubber latex see section 4.
Expand all Collapse all. Erosion score Week Changes since initial authorisation of medicine List item.