Krajina: Tanzánia
Jazyk: angličtina
Zdroj: Tanzania Medicinces & Medical Devices Authority
insulin glargine
Mylan Pharmaceutical Private Limited, INDIA
Insulins and analogues for injection, long-acting
insulin glargine
100 IU/ml
Injection
Biocon Limited, INDIA
Physical description: Clear colourless solution; Local technical representative: Synermed Pharmaceuticals (T) Limited (5197)
Registered/Compliant
2019-08-02
Effective date: 03/10/2022 TMDA/DMC/MRE/F/016 REV #:02 THEUNITEDREPUBLICOFTANZANIA MINISTRYOFHEALTH TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY PUBLIC ASSESSMENT REPORT FOR ENDULIN CART TM ( INSULIN GLARGINE 100 IU/ML) SOLUTION FOR INJECTION VERSION NUMBER 1 3 RD JANUARY, 2023 TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA ROAD, P. O. BOX 1253, DODOMA – TANZANIA, TELEPHONE: +255 (26) 2961989/2061990/+255 (22) 2450512/2450751/2452108, EMAIL: INFO@TMDA.OG.TZ, Website: WWW.TMDA.GO.TZ Toll free: 0800110084 Effective date: 03/10/2022 1 1. INTRODUCTION Endulin Cart is a generic medicine. Endulin Cart is an antidiabetic medicine belonging to A10AE04; Drugs used in diabetes, insulins and analogues for injection, long-acting. Endulin Cart exerts is activity by regulation of glucose metabolism. In addition insulin has several anabolic and anti-catabolic actions on a variety of different tissues. Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid output. The typical activity profile (glucose utilisation curve) following subcutaneous injection is illustrated below by the heavy line. Variations that a patient may experience in timing and/or intensity of insulin activity are illustrated by the shaded area. Individual variability will depend on factors such as size of dose, site of injection temperature and physical activity of the patient. Endulin Cart is approved in Tanzania for use in adults and elderly. 1.1 PRODUCT DETAILS Registration number TAN 21 HM 0261 Brand name Endulin Cart Generic name, strength and form insulin glargine 100 IU/ml Solution for injection ATC classification Drugs used in diabetes, insulins and analogues for injection, long-acting. ATC Code: A10AE04 Distribution category POM Country of origin India Associated product State any other product of formulation, strength or site that is linked or associated wi Prečítajte si celý dokument