Country: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
ERTUGLIFLOZIN (L-PGA)
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
A10BK04
FILM COATED TABLETS
ERTUGLIFLOZIN (L-PGA) 5 MG
PER OS
Required
MERCK SHARP & DOHME LLC, USA
ERTUGLIFLOZIN
Steglatro 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:• as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.• in addition to other medicinal products for the treatment of diabetes.
2023-12-31
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine is to be supplied upon physician’s prescription only STEGLATRO ® 5 MG STEGLATRO ® 15 MG FILM-COATED TABLET Each Steglatro 5 mg film-coated tablet contains: 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) Each Steglatro 15 mg film-coated tablet contains: 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) For a list of inactive ingredients see section 6 “Further information”. See also section 2.8 “Important information about some of the ingredients of the medicine”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY 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 ailment is similar. 1. WHAT THE MEDICINE IS INTENDED FOR? Steglatro is intended, in addition to diet and exercise, to improve the control of sugar levels in the blood in adults aged 18 years and older with type 2 diabetes: as a single treatment in patients which can’t receive treatment with metformin or as an addition to other medicines which are intended for the use in diabetes. THERAPEUTIC GROUP: Steglatro contains the active substance ertugliflozin. Steglatro is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. HOW STEGLATRO WORKS Ertugliflozin works by blocking the SGLT2 protein in your kidneys causing increased excretion of the glucose in the urine. WHAT IS TYPE 2 DIABETES? Type 2 diabetes is a condition in which your body does not make enough insulin or the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness and poor circulation. 2. BEFORE US সম্পূর্ণ নথি পড়ুন
1 1. NAME OF THE MEDICINAL PRODUCT Steglatro 5 mg Steglatro 15 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Steglatro 5 mg Each tablet contains 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid). _Excipient(s) with known effect _ Each tablet contains 28 mg of lactose (as monohydrate). Steglatro 15 mg Each tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid). _Excipient(s) with known effect _ Each tablet contains 85 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Steglatro 5 mg Pink, 6.4 x 6.6 mm, triangular-shaped, film-coated tablets debossed with “701” on one side and plain on the other side. Steglatro 15 mg Red, 9.0 x 9.4 mm, triangular-shaped, film-coated tablets debossed with “702” on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Steglatro 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: • as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. • in addition to other medicinal products for the treatment of diabetes. (For study results with respect to combinations and effects on glycaemic control see sections 4.4, 4.5, and 5.1.) 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose of ertugliflozin is 5 mg once daily. In patients tolerating ertugliflozin 5 mg once daily, the dose can be increased to 15 mg once daily if additional glycaemic control is needed. When ertugliflozin 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 sections 4.4, 4.5, and 4.8). In patients with volume depletion, correcting this condition prior to initiation of ertugliflozin is recommended (see section 4.4). If a dose is missed, it should be taken as soon সম্পূর্ণ নথি পড়ুন