Inflectra 100mg.

What is Inflectra and what is it used for?
Inflectra is an anti-inflammatory drug which contains the active substance infliximab (infliximab). It is generally used when other drugs or treatments were ineffective in adults with the following diseases:
• rheumatoid arthritis (an immune system disease that causes inflammation of the joints). Inflectra used with methotrexate (a drug that acts on the immune system);
• Crohn's disease (a disease which causes inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulae, abnormal passageways between the gut and other organs);
• ulcerative colitis (a disease that causes inflammation and ulceration of the lining of the gut);
• ankylosing spondylitis (a disease that causes inflammation and pain in the spine);
• psoriatic arthritis (disease causing red, scaly patches of skin and joint inflammation);
• psoriasis (a disease causing red, scaly patches on the skin).
Inflectra be used in patients aged between six and 17 years with severe Crohn's disease in active phase or severe ulcerative colitis in the active stage, when not responded to or can not tolerate other drugs or treatments.
For product details, see the Summary of Product Characteristics (also part of the EPAR).
Inflectra is "biosimilar" medicine. This means that Inflectra is similar to a biological medicine (the 'reference medicine'), which is already authorized in the European Union (EU) and that Inflectra and the reference medicine contain the same active ingredient. The reference medicine for Inflectra is Remicade. For more information on biosimilar medicines, see the document type questions and answers here.
How to use Inflectra?
Inflectra is supplied as a powder for solution for infusion (infusion) into a vein. The medicinal product subject to medical prescription and treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of diseases that can be treated with Inflectra.
In rheumatoid arthritis typically Inflectra administered at a dose of 3 mg per kilogram body weight, although, if necessary, the dose may be increased. For other diseases, the dose is 5 mg per kilogram body weight. How often have to repeat the treatment depends on the condition being treated and the patient's response.
Inflectra be administered as an infusion over one or two hours. All patients were monitored for reactions during the infusion and at least one to two hours thereafter. To reduce the risk of reactions related to the infusion, patients unable to take other medicines before or during treatment with Inflectra or time of infusion can be slowed down. For more information, see the Package Leaflet.
Patients who receive Inflectra, should be given a special alert card caution, containing information on safe drug administration.
How does Inflectra?
The active substance in Inflectra, infliximab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognize and bind to a specific structure (called an antigen) in the body. Infliximab is designed so as to bind to a chemical messenger in the body called tumor necrosis factor-alpha (TNF-alpha). This mediator is involved in causing inflammation and is found at high levels in patients with disorders for which a treatment is used Inflectra. By blocking TNF-alpha, infliximab alleviates the inflammation and other symptoms of the diseases.
Inflectra is produced by a method known as "recombinant DNA technology". Infliximab is produced by cells that have received a gene (DNA), which makes them able to produce it.
What benefit Inflectra during the studies?
Inflectra was studied to show that it is comparable with the reference medicine, Remicade. Inflectra compared with Remicade in one main study in 606 adult rheumatoid arthritis. For 30 weeks, patients receiving or Inflectra, or Remicade in addition to methotrexate. The main measure of effectiveness was the change in symptoms. After 30 weeks of
treatment Inflectra is as effective as Remicade, the approximately 60% of patients responded to treatment with either drug.
An additional study in 250 patients with ankylosing spondylitis, to show that Inflectra produces levels of the active substance in the body, which are comparable to those of the reference medicine, Remicade.
What are the risks associated with Inflectra?
The most common side effects with Inflectra (seen in more than 1 in
10) are viral infections (e.g., influenza or herpes), headache, infection of the upper respiratory tract (common cold), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (abdominal pain), reactions and pain associated Infusion
Inflectra should not be used in patients who have previously demonstrated hypersensitivity (allergy) to infliximab or who are hypersensitive (allergic) to murine proteins or any of the other ingredients of Inflectra. Inflectra should not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (inability of the heart to pump enough blood to the body).
For a full list of restrictions, see the Package Leaflet.
Why Inflectra is approved?
The Committee for Medicinal Products for Human Use (CHMP) of the Agency decides, in accordance with EU requirements, has been shown to Inflectra is comparable profile for quality, safety and efficacy as Remicade. Therefore, the CHMP considers that both Remicade, benefits outweigh its risks. The Committee recommended Inflectra be authorized in the EU.
What measures are being taken to ensure the safe and effective use of Inflectra?
A plan risk management to ensure that Inflectra used as safely as possible. Based on this plan, the safety information is included in the SPC and package leaflet for Inflectra, including appropriate safeguards for healthcare professionals and patients.
The firm, which offers Inflectra market will provide educational material for doctors who are expected to prescribe the drug for adults and children, including information on the medicine's safety and alert card to be given to patients. The company will also conduct studies to confirm the long-term safety of the drug.
Additional information about Inflectra

 

Write a review

Your Name:

Your Review: Note: HTML is not translated!

Rating: Bad           Good

Enter the code in the box below: