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' 'The most common adverse drug reactions (incidence rate above %) are diarrhea, rash, itching, dry skin and acne.
' ' Adverse events occurring in each body system are arranged in descending order by frequency (common&), common&), % and % common&), .% and % rare, .% and .extremely rare.%).
' ' The possible adverse events are summarized as follows
' ' Diarrhea is common in the digestive system, mainly mild (grade), rarely moderate (grade), and severe diarrhea accompanied by dehydration (grade) has been reported in some cases. ). Common nausea, mainly mild (grade) Vomiting, mainly mild or moderate (or grade) Anorexia, mild or moderate (or grade) Oral mucositis, mostly mild (grade) Occurs in diarrhea, nausea, vomiting Or dehydrated oral ulcers due to anorexia. Pancreatitis is rare.
' ' Skin reactions are common on the skin and appendages, mainly mild or moderate (or grade) pustular rash, sometimes accompanied by dry skin on the basis of erythema. Itching. Nail abnormalities are common.
' ' Metabolic and nutritional liver function abnormalities are common, mainly including asymptomatic mild or moderate elevation of transaminase (or grade).
' ' General fatigue is common, Mostly mild (grade) hair loss, weight loss, peripheral edema.
' ' Contraindications: Those who have severe allergic reactions to the active substance or any excipient of the product are prohibited. Storage/Storage below the expiration date. Validity period is months .
' ' There are no controlled studies showing clinical benefit in terms of improving disease-related symptoms and prolonging survival. The available data for this product in the second-line treatment of non-small cell lung cancer are only based on non-specific
' 'According to clinical studies, yet to be further confirmed by well-designed controlled clinical trials.
' ', Pharmacological effects' ' Gefitinib extensively inhibits the growth of human tumor cells xenografted in nude mice and inhibits their blood vessels Generation. In vitro, it can increase the apoptosis of human tumor cell-derived lines and inhibit the invasion and secretion of angiogenic factors. It has been confirmed in animal experiments or in vitro studies that gefitinib can improve the resistance to chemotherapy, radiotherapy and hormone therapy. Tumor Activity.
' ' Clinical Studies Large, phase-1 clinical studies evaluated the efficacy and safety of this product as a single agent in the treatment of locally advanced or metastatic non-small cell lung cancer. Patients' performance status score was and must be Previous chemotherapy failures
' ' (Study), received or prior chemotherapy regimens, at least one of which included platinum-based therapy (median age, . years [years].
' ' (Study) , had previously received one or more chemotherapy regimens, which included platinum and docetaxel simultaneously or sequentially (median age was years [years]).
' 'The designs of the two studies were similar, Both were double-blind, parallel-group, multicenter, evaluating two oral doses of gefitinib/day and/day. Patients were randomly assigned to these two dose groups. The primary endpoint was objective tumor response rate, The primary endpoints are disease-related symptom improvement. The primary endpoints are objective tumor response rate and disease-related symptom improvement rate (measured weekly).
' ' A summary of the efficacy results and efficacy results is shown in the table below. Not Taking into account the performance status score (, or) and the number of previous chemotherapy treatments, the results of the objective tumor response rate and disease-related symptom improvement rate obtained in the two studies were similar. Most patients' objective tumor response occurred in the first month of treatment, and a small number of patients Patients' objective response may occur as late as the first month of treatment.
' In both trials, Japanese patients had a higher objective response rate than non-Japanese patients (.%.%%.%) , the unadjusted odds ratio (both groups combined) is . In multivariable analysis, after adjusting for sex, histology, and performance status, this difference was no longer statistically significant (adjusted odds ratio .).
' Populations that can be evaluated based on symptom improvement ( ).
' ' Still continuing when the data ends.
' 'Quality of life measurement scale for lung cancer patients.
' ' Not calculated.
' ' Survival without progress.
' ' The safety profile of safety products was similar in the two studies, and the incidence and severity of adverse events were dose-related (see Adverse Reactions).
' ' , Pharmacology and Toxicology' ' Pharmacokinetic Properties
' ' Gefitinib is a selective inhibitor of epidermal growth factor receptor tyrosine kinase, an enzyme normally expressed in epithelial sources of solid tumors. Inhibition of tyrosine kinase activity can hinder tumor growth.
' ', Drug Metabolism' ' After intravenous administration, the average terminal half-life is 1 hour. Gefitinib accumulates at times of daily administration and reaches steady state after several days of administration.
Absorption
' ' Following oral administration, peak plasma concentrations of gefitinib occur to hours post-dose. The average absorption bioavailability in cancer patients is %. Food has no significant effect on the absorption of gefitinib. In an experiment with healthy volunteers, the absorption of gefitinib was reduced by % when values were maintained above (see sections 1 and 2).
Distribution
' The mean volume of distribution of gefitinib at steady state is, indicating widespread tissue distribution.
Metabolism
' ' In vitro study data indicate that there are only isoenzymes involved in the oxidative metabolism of gefitinib. In vitro studies suggest that gefitinib may have limited enzyme inhibition. In a clinical trial, coadministration of gefitinib with metoprolol, an enzyme substrate, resulted in a small increase (%) in the effect of this group, the actual clinical significance of which has not yet been estimated. Gefitinib showed no enzyme induction in animal experiments and did not significantly inhibit other cytochrome enzymes (in vitro).
Clearance
' ' The total plasma clearance of gefitinib is approximately /. It is mainly excreted through feces, and about % is cleared through the kidneys in the form of prototypes and metabolites.