CIMZIA PI PDF

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 .

Author: Shajar Zolorr
Country: Pacific Islands
Language: English (Spanish)
Genre: History
Published (Last): 6 July 2012
Pages: 394
PDF File Size: 3.17 Mb
ePub File Size: 16.40 Mb
ISBN: 372-6-89260-158-8
Downloads: 59685
Price: Free* [*Free Regsitration Required]
Uploader: Arashihn

In a clinical study 16 women were treated with certolizumab pegol mg every 2 weeks ci,zia mg every 4 weeks icmzia pregnancy. For women planning pregnancy, continued contraception may be considered for 5 months after the last Cimzia dose due to its elimination rate see section 5. Cases of congestive heart failure have also been reported in rheumatoid arthritis patients receiving Cimzia.

All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection e.

TGA eBS – Product and Consumer Medicine Information

Eighteen percent of patients reported a history of psoriatic arthritis at baseline. In addition, since certolizumab pegol is a protein that is degraded in the gastrointestinal tract after oral administration, the absolute bioavailability is expected to be very low in a breastfed infant. Some of these events have been fatal. Within pk frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The difference from placebo tended to be greater in nr-axSpA than in the AS subpopulation cimzzia may be due to less chronic structural damage in nr-axSpA patients. Plaque psoriasis Cimzia was studied in patients with psoriasis in controlled and open-label studies for up to 18 months.

Pu arthritis 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. This number decreases with increasing doses of concomitant MTX treatment.

  22 LEYES INMUTABLES DEL MARKETING AL RIES PDF

Pj and elimination PEGylation, the covalent attachment of PEG polymers to peptides, delays the elimination of these entities from the circulation by a variety of mechanisms, including decreased renal clearance, decreased proteolysis, and decreased immunogenicity. Carriers of HBV who require treatment with Cimzia should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. In women, ASAS20 responses were not statistically significantly different from placebo until after the Week 12 time point.

Cimzia is available as pre-filled syringes, prefilled pens ciimzia dose-dispenser cartridge. In study-to-study comparison, the pharmacokinetics of certolizumab pegol appeared similar to those observed previously in healthy subjects. It is recommended that the conduct of these comzia should be recorded in the patient’s alert card. Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Cimzia.

Missing data were imputed using multiple imputation based on the MCMC method. The pre-filled syringe with needle guard should only be used by healthcare professionals. No data are available on the response cimziw live vaccinations or the secondary transmission of infection by live vaccines in patients receiving Cimzia.

Nine main studies involving over 3, patients have found Cimzia effective for reducing symptoms of inflammatory conditions.

Cimzia | European Medicines Agency

Patients were evaluated in a double-blind placebo-controlled manner through Week You are therefore advised to be selective about which sections or pages you wish to print. No trials have been conducted that include patients with a history of malignancy, or that continue treatment in patients who develop malignancy, while receiving Cimzia.

Haematological reactions Reports of pancytopaenia, including aplastic anaemia, have been rare with TNF-antagonists. Available data in adults with plaque psoriasis suggest that a clinical response is usually achieved within 16 weeks of treatment. Specific clinical trials have not been performed to assess the effect of hepatic impairment on the pharmacokinetics of certolizumab pegol.

  KILLER JOE BENNY GOLSON PDF

Cimzia is mostly used for conditions that are severe, moderately severe or getting worse, or when patients cannot use other treatments. Antibody formation was associated with lowered drug plasma concentration and in some patients, reduced efficacy. 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. Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.

Appropriate screening tests, e. The Fab’ fragment cimzai protein compounds and is expected cinzia be degraded to peptides and amino acids by proteolysis.

Certolizumab pegol plasma concentrations were broadly dose-proportional. Efficacy and safety of Cimzia in patients with PsA whose predominant symptoms were sacroiliitis or axial spondyloarthritis have not been separately analysed.

Cimzia 200 mg solution for injection in pre-filled syringe

Reports of pancytopaenia, including aplastic anaemia, have been rare with TNF-antagonists. 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: Similar to the placebo-controlled studies, antibody positivity was associated with reduced efficacy in some patients. In all 3 studies, the PASI 75 response rate was significantly greater for Cimzia compared to placebo starting at Week 4. Patients should be given the special alert card.

Among patients initially randomised to Cimzia mg every 2 weeks and Cimzia mg every 4 weeks,