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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Cimzia-treated patients reported statistically significant improvements in the Work Productivity Survey cimzai to placebo. If severe reactions occur, administration of Cimzia should be discontinued immediately and appropriate therapy instituted. Side effects reported with Cimzia are carefully evaluated and any necessary action taken to protect patients. It is given by injection under the skin, usually in the thigh or abdomen tummy.

Because the elimination of certolizumab pegol may take up to 5 months, monitoring should be continued throughout this period see section 4. All subjects who did not achieve a PASI 75 response at Week 16 entered an escape arm and received Cimzia mg every 2 weeks.

Adults with severe active ankylosing spondylitis who have had cimzla inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs NSAIDs. Excluding non-melanoma of the skin, malignancies including 5 cases of lymphoma were observed in the Cimzia RA clinical trials in which a total of 4, patients were treated, representing 9, patient-years.

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Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs NSAIDs. The Fab’ fragment comprises protein compounds and is expected to be degraded to peptides and amino acids by proteolysis. 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.

Cimzia contains the active substance certolizumab pegol. Therefore, early detection of any infection, particularly atypical clinical presentations of a serious infection, is critical to minimise delays in diagnosis and initiation of treatment. Absorption Following subcutaneous administration, peak plasma concentrations of certolizumab pegol were attained between 54 and hours post-injection.

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Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. In both studies patients were randomized to receive placebo or Cimzia mg every 2 weeks following a loading dose of Cimzia mg at Weeks 0, 2 and 4 or Cimzia mg every 2 weeks. The value of these data to the evaluation of human risk may be limited.

Antibody formation was associated with lowered drug plasma concentration and in some patients, reduced efficacy. 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.

In male rats, reduced sperm motility and a trend of reduced sperm count were observed. However, population pharmacokinetic analysis based on subjects with mild renal impairment showed no effect of creatinine clearance.

Cimzia 200 mg solution for injection in pre-filled syringe

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.

Treatment with Cimzia mg every two weeks in the two studies led to Specific clinical trials have not been performed in elderly patients subjects. Cimzia may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.

JSN score Week For these reasons, comparison of the incidence of antibodies to Cimzia with the incidence of antibodies to other TNF-antagonists is not appropriate.

The maximum duration of the study was weeks.

In the placebo-controlled studies, patients receiving Cimzia had an approximately 4 times greater duration of exposure compared with the placebo group. At Weeks 12 and 24, the percentage of subjects with an ASAS40 response was greater in the Cimzia-treated groups compared to placebo. The needle shield inside the removable cap of the CIMZIA pre-filled syringe contains a derivative of natural rubber latex see section 6. The presence of antibodies to certolizumab pegol resulted in an approximately three-fold increase in clearance.

Contact with natural rubber latex may cause severe allergic reactions in individuals sensitive to latex. Cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

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Reporting suspected adverse reactions after authorisation of the medicinal product is important. Additionally, the observed incidence of antibodies in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medicinal products, and underlying disease.

Some of these reactions occurred after the first administration of Cimzia. Caution should be exercised when treating the elderly patients, and particular attention paid with respect clmzia occurrence of infections.

This information is intended for use by health professionals. No data are available on the response to live vaccinations or the secondary transmission of infection by live vaccines in patients receiving Cimzia.

See also section 6. 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. Wald p-values are quoted for the comparison of treatments using logistic regression with factors for treatment and region.

Similarly, on the basis of Phase III clinical trial data in patients with psoriasis, a population exposure-response relationship was established between plasma concentration of certolizumab pegol and PASI with an EC90 of Patients were evaluated in a double-blind placebo-controlled manner through Week Cimzia-treated patients reported significant improvements in axial spondyloarthritis-related productivity at work and within household, as reported by the Work Productivity Survey as compared to placebo.

Results are from the Randomized Set. Antibody formation was associated with lowered drug plasma concentration. Nine main studies involving over 3, patients have found Cimzia effective for reducing symptoms of inflammatory conditions. Reproductive system and breast disorders. Changes since initial authorisation of medicine List item. No mutagenic or clastogenic effects were demonstrated in preclinical studies. 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.

Activated partial thromboplastin time aPTT assay Interference with certain coagulation assays has been detected in patients treated with Cimzia.