Country: Израел
Језик: Енглески
Извор: Ministry of Health
SITAGLIPTIN AS MONOHYDRATE PHOSPHATE
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
A10BH01
FILM COATED TABLETS
SITAGLIPTIN AS MONOHYDRATE PHOSPHATE 100 MG
PER OS
Required
MERCK SHARP & DOHME LLC, USA
SITAGLIPTIN
SITAGLIPTIN
Januvia is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus.Important limitations of use:Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings.Januvia has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Januvia.
2023-03-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is marketed upon physician's prescription only JANUVIA ® 25 MG JANUVIA ® 50 MG JANUVIA ® 100 MG Film-coated tablets Film-coated tablets Film-coated tablets EACH FILM-COATED TABLET CONTAINS: Sitagliptin (as monohydrate Sitagliptin (as monohydrate Sitagliptin (as monohydrate phosphate) 25 mg phosphate) 50 mg phosphate) 100 mg For a list of inactive ingredients please refer to section 6 “FURTHER INFORMATION”. See also section 2.8 “Important information about some of the ingredients of the medicine”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. • This leaflet contains concise information about JANUVIA. If you have any further questions, refer to the doctor or pharmacist • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar • This medicine is not intended for administration to children and adolescents under 18 years of age 1. WHAT JANUVIA IS INTENDED FOR? JANUVIA is indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus. IMPORTANT LIMITATIONS OF USE: JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA. THERAPEUTIC GROUP : DPP-4 enzyme inhibitors. JANUVIA is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus. 2. BEFORE USING JANUVIA 2.1 DO NOT USE JANUVIA IF YOU: − are allergic (sensitive) to any of the ingredients of JANUVIA (see section 6 "FURTHER INFORMATION" for a complete list Прочитајте комплетан документ
JANUVIA ® 25 MG, FILM COATED TABLETS Each film-coated tablet contains 25 mg Sitagliptin (as monohydrate phosphate) JANUVIA ® 50MG, FILM COATED TABLETS Each film-coated tablet contains 50 mg Sitagliptin (as monohydrate phosphate) JANUVIA ® 100MG, FILM COATED TABLETS Each film-coated tablet contains 100 mg Sitagliptin (as monohydrate phosphate) 1 THERAPEUTIC INDICATIONS JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. _ _ IMPORTANT LIMITATIONS OF USE JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA. _[See_ _Warnings and Precautions (5.1)._] _ _ 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSING The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. 2.2 RECOMMENDATIONS FOR USE IN RENAL IMPAIRMENT For patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1.73 m² to less than 90 mL/min/1.73 m², no dosage adjustment for JANUVIA is required. For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m² to less than 45 mL/min/1.73 m²), the dose of JANUVIA is 50 mg once daily. For patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m²) or with end- stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of dialysis. Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter. There have been postmarketing reports of worsening renal function in patients with renal imp Прочитајте комплетан документ