Adresse Original: Glivec (tablets msyl
bill consolidation loan mortgage second ate of Imatinib) investigation Author: Gleevec
- Following the instructions provided by Dr. Kang how a notebook data recovery bucket Pharmacy. Original address: ht new jersey home equity loan rates tp: / / www.360kad.com/product/120.shtml product name? drug name?: common names Gleevec: English name of tablets msylate Imatinib: Imatinib Mesylate Capsules Hanyu Pinyin: Jiahuangsuan Yimatini Jiaonang
- ? Gleevec composition? msylate of Imatinib
- "Pharmacological action of Gleevec" mcanisme of action and pharmacodynamics caractristiques: Imatinib at the cellular level in vivo and in vitro inhibition of Bcr-Abl tyrosine kinase inhibition slective Bcr-Abl positive cells in the cell, Philadelphia chromosome-positive (Ph +) patients leucmie mylo? of chronic (CML) and costs among patients with Leuc Acute lymphoblastic economy? cell growth and induces apoptosis. In addition, imatinib can also inhibit growth factor rcepteurs driv platelets (PDGF), stem cell factor (SCF), c-kit tyrosine kinase rcepteur, inhibiting PDGF and cell behavior mdie stem cell. Gastrointestinal stromal tumors (GIST) cells express activity kit mutations in vitro have shown striking expriences Imatinib GIST cell proliferation and induced apoptosis. Tips prcliniques and clinics, some patients may be thanks DIFFERENT mcanismes become resist to medicinal products. A study Clinical patients leucmie mylo? of chronic (see Table 1) on the Philadelphia chromosome positive leucmie mylo? of chronic blast (mylo? of original cell crisis), acceleration phase and a Failed-interfron treatment in patients with chronic phase for three groups of open, not contr? the phase II study. In a large, open, placebo-controlled phase III clinical trial, patients with newly diagnosed Philadelphia chromosome positive chronic leucmie (Philadelphia, + CML). On the treatment of children and young people in phase two studies I. Clinical case study, 38% - 40% of patients 60 years, 10% ~ 12 70. newly diagnosed chronic phase: the first time in June 1106 Previous patients diagnosed CML in phase III clinical trials for the group, comparison of m sylate of imatinib to 400 mg / day and interfron (INF) 5 million + IU/m2/jours ARA (Ara-C) RESULT 20 mg/m2/day (10 days / month). 80% of hydroxyurea-treated patients before taking the medicinal product exprimental, testing for the first 6 months, 50% and 75% taken from patients of msylate Imatinib while continuing to use hydroxyurea in patients taking IFN-Ara-C (an average of 15 and 30 days respectively). Analysis of medium-term APRS 12 months msylate imatinib and IFN-Ara-C groups hmatologique Answers to UNESCORecords (CHR) and 94.4% respectively and Answers to major cytogntique 82.6% The answer UNESCORecords cytogntique and 67.8%. Verify GRE is a questionnaire for the assessment of the quality of life, msylate imatinib group all scores are more levs that the group of IFN-Ara-C, the data indicate that the quality of life of patients receiving treatment with Imatinib of msylate enough to maintain a good mood. Failed treatment of A-interfron in patients with chronic phase: CHAC 60% (532 cases, from 400 mg once daily) the
cytogntique Answers to most, 42% silent rmission a complete te, 93% of an answer silent hmatologique tutorials. Acceleration phase: (235 cases in which, T replacement therapy has agreed for 63% of patients acclr, 235 77 cases patients receiving imatinib for msylate 400 mg once daily, 158 cases received 600 mg once daily). Get the exact ractions hmatologiques patients with 70% of feedback, the ractions hmatologiques UNESCORecords patients with 28% and 25% obtain The answer cytogntique appropriate in patients with major cytogntique CHAC The answer (to split cells in Philadelphia chromosome positive < 35 %) remise cytog��n��tique compl��te de 18 %. Analyse d'h��matologie de l'att��nuation de la dose de point de terminaison, 400 et 600 mg primaire ne trouv�� aucune diff��rence significative entre les groupes, groupe de dose de 600 mg de r��ponse cytog��n��tique am��liorations plus visibles, sa dur��e est plus long. Dans la pr��sente ��tude, groupe de dose de 600 mg de maladies le temps n��cessaire au progr��s significativement diff��rent.
Blast crisis (mylo? of original crisis) (260, 95 cases [37%] after you input a PERIOD of a blast or accelerates re? ua chimiothrapie , 165 [63%] re not already? ua chimiothrapie. dose treatment beginners case 223 is 600 mg once daily). UNESCORecords ractions hmatologiques as the main effect of DIFFERENT statistics, 31% re? Ilo recognition ractions hmatologiques (do not reset? U treatment of patients 36% APRS treatment of patients with 22%), The answer cytogntique observed in patients by 15%. The treatment does not accept and receive the mdian survival time of patients and 7.7 months respectively. The interfrons patients with Failed treatment (chronic) (532 cases, from 400 mg once daily) 49% of patients accder The answer cytogntique appropriate, 30% a silent rmission UNESCORecords, 88% of an answer silent hmatologique tutorials. children and adolescents: CML in chronic phase (15 people) or acute leucmie? CML or Philadelphia chromosome blast (16) a total of 31 children in groups of patients with increasing dose in phase I trials, one percent of CML patients aged 28%, 50% over the years. Conformment patients following the Reception msylate of imatinib, dose / m 2 260 mg / day (n = 6), 340 mg de/M2/jours (n = 11) / m 2, 440 mg / day (N = 8) and 570 mg/m2/day (n = 6). Cytogntique information obtained in 13 cases of CML patients, 7 cytogntique Answers to UNESCORecords (54%), 4 (31%) partially Answers to cytog ntique, which is equivalent rates of major cytogntique Answers to 85%. 8 children (3 CML, the acute leucmie? In 4) to conduct a Phase I trial, 3 people with a dose of 173-200 mg/m2/day, / m doses for 4 people about 260 mg 2/day, 1 mg doses of 360 acceptable de/M2/jours. 3 CML have two cytogntique Answers to complte. Compared with adult trials, a total of 39 children have no particular problem of security. Gastrointestinal stromal tumors (GIST) of clinical research: for patients or non rscable mtastatique gastrointestinal stromal tumors (GIST) were opened, Randomized, many countries participate in Phase II clinical trials. In this trial, winning a total of 147 patients and randomly re? Oivent treatment with oral imatinib 400 or 600 mg once daily, treatment means 6 in 12 months (n'excdant not 24 months). Under these patients 18-83 years, pathological diagnosis of malignant C-Kit positive gastrointestinal stromal tumors (GIST) and non rscable or transformed. Discount rate for group 37% 400 mg, 600 mg group 43.2%, there is no case of rmission tutorials. Grace tracking average of 7 months (7 days-13 months), progression of attnuation patient does not work. ? Gleevec pharmacocintique? pharmacocintique Gleevec is a single oral dose and post-evaluation of the steady state, 25 ~ 1000 mg dose range aprsmsylate of Imatinib and determination to constant. IBA msylate for Niben doses in the range 25 ~ 1000 mg, the average area under the curve increases (AUC) with dose proportionality relationship exists. Rpter when the cumulative amount may be up to the pharmacocintique the steady states of medicinal products 1.5 ~ 2.5 times. The studies pharmacocintiques adult population have shown that sex does not affect the pharmacocintique, influence of body weight can also be map. Absorption: The average absolute bioavailability of 98% capsules, taken orally once msylate Iba for plasma AUC APRS coefficient of variation Niben fluctuations between 40 ~ 60%. compared with an empty stomach, absorption of this medicinal product that APRS high fat rgime Reduces minimum (Cmax little tight t max 11%) Reduces lightly AUC (7.4%). Distribution: 95% and plasma binding Protin, especially with albumin, fewer pieces a combination of alpha-acid glycoprotine that very few pieces a combination of lipoprotines. Distribution of concentration in the body as a whole, the capacity distribution of 4.9 l / kg of body weight, low payout ratio of red blood cells. On drug distribution in tissues of the body give prcliniques only. Levels levs exposure in the gland and the gonads surrnale, low levels of exposure in the central nervous systm. Mtabolisme: major mtabolites circulating in the human body is the drive nmthyl vitro efficacy similar raw. The mtabolites in plasma AUC is the original medicinal product msylate imatinib AUC by 16%. Msylate imatinib is a substrate of CYP3A4 and CYP3A4, CYP2D6 and CYP2C9 and CYP2C19 inhibitors and therefore may affect mtabolisme while giving (see mdicamenteuses interactions). The excrtion: clearance half-life of msylate of imatinib for 18 hours, its half-life of 40 hours mtabolites assets and the excrtion doses of m medicament given within 7 days of 81%, that of excrtion FCAL 68% in the urine of 13% excrtion. About 25% of the original drug (5% in urine, feces 20%) other mtabolites the stool and urine in the ratio of assets and mtabolites similar medicinal products. Spcial pharmacocintique Clinical given the same dose (400 mg / day), and its state of equilibrium is the degree of exposure of the drug in GIST patients with CML 1.5-fold. According to the study population pharmacocintiques preliminary as of GIST patients, imatinib change indicators Pharmacocintique 3 (albumin, WBC and bilirubin) have a significant impact on statistics. Minimizing low albumin level and high WBC compensation (CL / f). But these effects are not sufficient to conclude that doses must be adjusted. Medicinal products in children: children and adolescents and 340 mg/m2 260 mg/m2 dose used will produce the same amount of exposure to drugs, respectively, the equivalent of 400 and 600 mg for adults. 340 mg once a day dose rpt/m2/jours APRS delivery, the 8th day and two Reveals AUC (0-24), it is 1.7 times the accumulation of the drug. Liver and kidney failure: for patients with renal and hpatique Journ al, no clinical study has effectus t, these patients caution when applying msylate of Imatinib. Known to excrtion msylate of Imatinib bit of kidney, it is estimated that taking the problem does not occur in patients suffering from kidney failure. ? Gleevec indications? used in the treatment of leucmie mylo? Of chronic (CML) in blast crisis, Thrap phase or alpha-interfron in patients with APRS Failed the chronic phase of acceleration. For treatment of non rscable mtastatiques or malignant gastrointestinal stromal tumors (GIST) in adult patients. ? Gleevec administration and dosage? beginners treatment should be taken by the Physicians for the treatment of leucmie mylo? Chronic. Acclr blast phase and the dose recommended for patients with msylate of imatinib 600 mg daily for the treatment interfron Failed in patients with Chronic 400 mg / day once daily orally preferences in Medicine of the meal and drink a full glass of water, as valid, it should take. If the license of hemogram, no serious effects of medicinal products indsirables, dose may be taken into account in the following cases have increased by 400 mg / 600 mg / or augment 600 mg / 800 mg (400 mg, orally, taking 2 times): disease progression, treatment of at least 3 months after the Failed to obtain satisfaction r hmatologiques actions, Answers to hmatologique did disappear? be new. ? Gleevec indsirable? the majority of patients taking imatinib PERIOD msylate there will be some vnements indsirables, but the vast majority of gre Modra. The most frequent providers indsirables effects associated with medicinal products have mild nausea (becomes prohibitive), vomiting, diarrhea, myalgia and muscle spasms, these effects are easy indsirables grate. ? Gleevec taboo? on the activity of this drug allergic substances or components of a vehicle is disabled. ? Gleevec warnings? ago rtention water STRID 1 ~ 2% of patients taking this product (pleural fluid and oedme on? Dme pulmonary ascites), It is recommended a regularly monitoring weight and body weight increases should be carefully and capital gains, if ncessaire, Thrap take the appropriate support. Particulirement pdiatrique, rtention water may be not appear? Be recogn? Be the rtention oedme water. may worsen or cause heart failure, there is no causing severe heart failure (according to the classification of the New York Heart Association class III-~) clinical application the quality of the experience. Use caution in patients with this medicinal product should also be used with caution in patients with glaucoma (see ractions indsirables). In clinical trials for the most part, reported in 8 patients (5.4%) of gastrointestinal hmorragies occurred in 4 hmorragie tumor patients (2.7 %) occurred. According to the site of tumors DIFFERENT, hmorragie the tumor may occur in the abdomen may also occur in the liver. Hmorragie of the tumor is also possible manifestation of such patients for hmorragies digestive and, therefore some of the beginner phase of treatment should be monitored in patients pr senting symptom? my gastro-intestinal. While taking this product and CYP3A4 inducers (interaction) can rduire Whereas the total amount of exposure to imatinib, increasing the risk of Failed treatment. So avoid this product in combination with inducers of CYP3A4. This product in patients with renal hpatique may increase the amount of exposure, liver function affect use of medicinal product. The medicinal product and safety of long-term clinical data are limited. The studies have shown that prcliniques msylate of imatinib is not easily through barrire hmato - encphalique. Search did not t in the human body. This first month of treatment should vrifier weekly whole blood, second-checking least once every two weeks thereafter, as may be NCESS (like 2-3 and months they again). If a neutrophil or platelet Minimizing serious, should be adjusted dose (see use). Function must be hpatique verifies before the start of treatment (including aminotransfrase, bilirubin and alkaline phosphatase), and check on a monthly basis or according to clinical decisions require timely dosage adjustments (see mthode of dose). Effect on the ability of the driver and operator instead machine: there is still no drivers or machine operator instead may affect the ability of Information and Materials. "Working with pregnant women and lactating Gleevec" pregnancy: studies in animals have shown that the medicinal product be toxic to the reproductive systm, but it ' is the lack of information for women, fetal toxicity is currently unknown. Unless you may use benefit is greater than the prejudice to the fetus / bb, or during pregnancy should not be applied. If taken during pregnancy msylate of Imatinib, you must indicate that the risk to the fetus can. Pregnant women to take imatinib mesylate in PERIOD should be review at the same time for effective contraception. Breastfeeding: express in animal msylate imatinib and its mtabolites excrts are large quantities of breast milk but no human studies have Ralis t, with Imatinib msylate women should not breastfeed. ? Gleevec child medicinal products? individual samples, plasma leves in children can be 1.5 to 2 times, give the n'taient not sufficient as a basis for the dose recommended medicinal products in children. ? Gleevec of medicinal products for people ages? experienced the clearance may be cratinine Reduces office on aging and age on pharmacocintique msylate to no apparent effect of imatinib. ? Gleevec drug interactions? you can change the plasma concentration of drug imatinib mesylate, inhibitors of CYP3A4 in healthy volunteers taking a single dose of ktoconazole (CYP3A4 inhibitors), imatinib msylate considerably increases ably the degree of exposure to drugs (the mean maximum plasma concentration (Cmax) and area under the curve (AUC) and 26% respectively and by consequences of msylate take imatinib and inhibitors CYP3A4 (eg ktoconazole, itraconazole, clarithromycin and rythromycine), take care. CYP3A4 inducers: found in clinical research and phnyto? APRS do drugs, plasma concentrations of imatinib msylate Reduces lower effect. Inducers such as dexamthasone other cards he effectiveness of chlorpromazine, rifampicin, and contain phnobarbital StJohn wort extract of readiness, and so on, may be a problem I like, but have not yet t Speciality in, so be cautious when taking these medicinal products. Msylate drug imatinib can make the following changes in plasma concentration of imatinib msylate Ding with simvastatin (CYP3A4 substrate), the mean Cmax and AUC increased by 3.5 times and twice times times respectively. When taking this medicinal product and the window therapist Strait CY Substrate P3A4 (such as cyclosporine, the effect of Qing meters) should be careful. Msylate imatinib may be increased by the CYP3A4 mtabolisme other plasma medicinal products (benzodiazpines class, dihydropyridine, calcium antagonists and h, mg inhibitors rductase-COA). And inhibition of CYP3A4 activity similar concentrations, msylate imatinib in vitro inhibition of CYP2D6 activity of cytochrome P450 isomrase, this product is used at the same time, it is possible to increase the total body contact with substrates of CYP2D6, although that has not made a study spcial, when medicinal products should always be cautious. Msylate imatinib in vitro inhibitory activity and CYD2C9 CYD2C19, and after taking warfarin may see $ thrombin time. At the time of this product in the treatment of any history or changing doses if used at the same time double coumarin, short-term monitoring of the thrombin time. Patients should be informed to avoid the use of medicinal products containing paractamol and prescription medicinal products. ? Gleevec store? This medicinal product should be saved in the 30 C or less. ? Gleevec approval? Record number of medicinal products imports H20100263 ? Gleevec production enterprise? Novartis Pharma Stein AG (Source: Kang how a network pharmacy: http://www.360kad.com/)
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