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Cetapin
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory Abridged Prescribing Information Cetapin V Metformin Hydrochloride Sustained Release and Voglibose Tablet COMPOSITION Cetapin V 0.2mg: Metformin hydrochloride IP (as sustained release) 500mg & Voglibose 0.2 mg. Cetapin V 0.3mg: Metformin hydrochloride IP (as sustained release) 500mg & Voglibose 0.3 mg. THERAPEUTIC INDICATIONS 2nd line treatment for type II diabetes mellitus when diet, exercise, single agent do not result in adequate glycemic control. DOSAGE AND ADMINISTRATION Adults - 1 tablet to be given 2-3 times daily with heavy meals.Safety and efficacy not established in children. Initiation at lower dose and close observation in case of elderly. Monitoring of renal function is necessary in elderly. Avoid in patients of hepatic insufficiency. Contraindicated in case of renal dysfunction. CONTRAINDICATIONS: Known hypersensitivity to metformin hydrochloride, voglibose or another component of this product ; renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5mg/dL (males), ≥ 1.4 mg/dL (females) or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse, acute myocardial infarction and septicaemia; acute or chronic metabolic acidosis including diabetic ketoacidosis with or without coma. Cetapin V should be temporarily discontinued in patients undergoing radiologic studies. Not to be used in patients with severe ketosis or in a state of diabetic coma or precoma, severe infections before or after operation or with severe trauma. WARNINGS: Lactic acidosis is a medical emergency that must be treated in hospital setting. Cetapin V must be discontinued immediately and general supportive measures promptly instituted. For patients undergoing basic treatment for diabetes mellitus, voglibose should be given when 2-hr post prandial blood sugar is 200mg/dl or more. For patients on oral hypoglycemic drugs or insulin preparations, in addition to dietary treatment and/or exercise therapy, voglibose is to be given when the fasting blood sugar is about 140mg / dl or more. Closely monitor blood sugar at regular intervals. PRECAUTIONS : No clinical studies establishing conclusive evidence of macrovascular risk reduction with metformin or any other anti-diabetic drug. Before initiation of Cetapin V therapy and annually while on Cetapin V therapy renal function should be assessed and verified as being within normal range. Concomitant medication that may affect renal function or result in significant hemodynamic change or may interfere with disposition of metformin should be used with caution. Intravascular contrast studies with iodinated material can lead to acute alteration of renal function, hence metformin should be temporarily discontinued in whom such studies are planned. Drug should be promptly discontinued in case of cardiovascular collapse, acute congestive heart failure, acute myocardial infarction and other conditions characterized by hypoxemia (may be associated with lactic acidosis). Cetapin V must be temporarily suspended before surgical intervention. Alcohol potentiates effect of metformin on lactate metabolism therefore patients should be warned against excessive alcohol intake. Cetapin V is to be avoided in patients with clinical or laboratory evidence of hepatic disease. Measurement of serum vitamin B12 levels every two to three years is recommended. Patient with Type II diabetes, previously well controlled on metformin, who develops laboratory abnormality or clinical illness should be promptly evaluated for lactic acidosis or ketoacidosis. Hypoglycemia could occur when caloric intake is deficient or strenuous exercise is not compensated. Withhold Cetapin V and temporarily administer insulin in case of temporary loss of glycemic control due to fever, trauma, infection or surgery. Periodic measurements of fasting blood glucose and glycosylated haemoglobin levels are required. Initial and periodic monitoring of hematologic parameters and renal function should be performed on annual basis. Administer carefully in patients receiving other antidiabetic drugs or with a history of laparotomy or ileus or with chronic intestinal disease accompanied by a disturbance in digestion and absorption or with Roemheld's syndrome, severe hernia or stenosis or ulceration of the large intestine or with serious hepatic dysfunction or with serious renal dysfunction. PREGNANCY & LACTATION: Should not be used in pregnancy unless clearly needed. Avoid administration of voglibose in lactation, however, if the administration is indispensable, nursing should be discontinued. Safety and efficacy in paediatric patients has not been established. ADVERSE REACTIONS: Voglibose : Gastrointestinal adverse effects like diarrhea, loose stools, abdominal pain, constipation, anorexia, nausea, vomiting and heartburn, abdominal swelling, increased flatus may occur. Serious hepatic dysfunction accompanied with jaundice, increased AST, ALT may occur. When administered to patients with serious liver cirrhosis, hyperammonemia may worsen with the development of constipation, etc, followed by
disturbance of consciousness. Hypoglycemia may occur. Metformin : Commonly reported adverse events include diarrhoea, nausea, vomiting. For full prescribing information please write to : Aventis Pharma Ltd., 54/A Sir Mathuradas Vasanji Road, Andheri (E), Mumbai - 400 093. Tel : 022 – 28 27 8000 Created : Jan 2012
Biocompatibility Assessment Study, Page 1 of 13 Report of Biocompatibility Assessment Studyof Core it Dual Prepared by: K.H. Beak /QA Approved by: J.H. Kim /President SPIDENT CO., LTD. Biocompatibility Assessment Study, Page 2 of 131. Purpose and references 2. Device description 3. Raw material of Core it Dual 4. Quantitative formulation 5. Flow chart to aid in systematic approach to b
Abstract Professional Career of the Invitee: Shotgun DNA sequencing bearing fruits: probing the dynamics of genome size Professor of Molecular Biology and Director Joachim (Jo) Messing DNA sequencing reactions can result in the determination of a Professional Experience (selection) contiguous order of bases of up to around 1,000 nucleotides. To 1988-present: Direct