Страна: Израиль
Язык: английский
Источник: Ministry of Health
ERTUGLIFLOZIN (L-PGA); SITAGLIPTIN AS MONOHYDRATE PHOSPHATE
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
A10BD24
FILM COATED TABLETS
SITAGLIPTIN AS MONOHYDRATE PHOSPHATE 100 MG; ERTUGLIFLOZIN (L-PGA) 15 MG
PER OS
Required
MERCK SHARP & DOHME LLC, USA
SITAGLIPTIN AND ERTUGLIFLOZIN
STEGLUJAN is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:• when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control• in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.
2021-04-04
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine is marketed upon physician's prescription only STEGLUJAN ® 5/100 MG TABLETS STEGLUJAN ® 15/100 MG TABLETS FILM-COATED TABLET Each STEGLUJAN 5/100 MG film-coated tablet contains: 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate). Each STEGLUJAN 15/100 MG film-coated tablet contains: 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate). For the list of inactive ingredients see section 6 “FURTHER INFORMATION”. See also section 2.9 “Important information about some of the ingredients of the medicine”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. • This leaflet contains concise information about the medicine. 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 medical condition is similar to yours. 1. WHAT STEGLUJAN IS INTENDED FOR? STEGLUJAN is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: • when metformin and/or a sulphonylurea (SU) and one of the monocomponents of STEGLUJAN do not provide adequate glycaemic control • in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets. THERAPEUTIC GROUP: • Ertugliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. • Sitagliptin belongs to a group of medicines called DPP-4 (dipeptidyl peptidase-4) inhibitors. HOW STEGLUJAN WORKS • Ertugliflozin works by blocking the SGLT2 protein in your kidneys. This causes blood sugar to be removed in your urine. • Sitagliptin helps to increase the levels of insulin produced after a meal. It also lowers the amount of sugar made by yo Прочитать полный документ
1 1. NAME OF THE MEDICINAL PRODUCT Steglujan ® 5/100 mg tablets Steglujan ® 15/100 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Steglujan 5/100 mg tablets Each tablet contains 5 mg ertugliflozin (as ertugliflozin L- pyroglutamic acid ) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate ). Steglujan 15/100 mg tablets Each tablet contains 15 mg ertugliflozin (as ertugliflozin L- pyroglutamic acid ) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate ). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet). Steglujan 5/100 mg tablets Beige, almond -shaped, film- coated tablets debossed with “554” on one side and plain on the other side. Steglujan 15/100 mg tablets Brown, almond -shaped, film- coated tablets debossed with “555” on one side and plain on the other side. 4. C LINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control : when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate gly caemic control . in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets. (For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5, and 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose is 5 mg ertugliflozin/100 mg si tagliptin once daily . In patients tolerating the starting dose , the dose may be increased to 15 mg ertugliflozin/100 mg sitagliptin, once daily, if additional glyc a emic control is needed. For patients treated with ertugliflozin who are being switched to Steglujan , the dose of ertugliflozin can be maintained. When Steglujan is used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue may be required to reduce the risk of hypoglycaemia (see se Прочитать полный документ