Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
ERTUGLIFLOZIN (L-PGA); METFORMIN HYDROCHLORIDE
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
A10BD23
FILM COATED TABLETS
METFORMIN HYDROCHLORIDE 1000 MG; ERTUGLIFLOZIN (L-PGA) 2.5 MG
PER OS
Required
MERCK SHARP & DOHME CORP., USA
METFORMIN AND ERTUGLIFLOZIN
Segluromet 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:• in patients not adequately controlled on their maximally tolerated dose of metformin alone• in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes • in patients already being treated with the combination of ertugliflozin and metformin as separate tablets.
2019-01-28
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine is to be supplied upon physician’s prescription only SEGLUROMET ® 2.5/1000 MG SEGLUROMET ® 7.5/1000 MG FILM-COATED TABLET Each Segluromet 2.5/1000 mg film-coated tablet contains: 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1000 mg of metformin hydrochloride. Each Segluromet 7.5/1000 mg film-coated tablet contains: 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1000 mg of metformin hydrochloride. For a list of inactive ingredients see section 6 “FURTHER INFORMATION”. See also section 2.10, “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 ? Segluromet 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: which are treated with metformin alone or in combination with other medicines and their sugar levels are not controlled, or for patients that receive a combination of metformin and ertugliflozin as separate tablets. THERAPEUTIC GROUP: Segluromet contains two active substances, ertugliflozin and metformin. • Ertugliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. • Metformin belongs to a group of medicines called biguanides. HOW SEGLUROMET WORKS • Ertugliflozin works by blocking the SGLT2 protein in your kidneys causing increased excretion of the glucose in the urine. • Metformin works by inhibiting sugar (glucose) production in the liver. WHAT IS TYPE 2 DIABETES? Type 2 diabetes is a condition in whic Pročitajte cijeli dokument
1 1. NAME OF THE MEDICINAL PRODUCT Segluromet ® 2.5 mg/1,000 mg Segluromet ® 7.5 mg/1,000 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Segluromet 2.5 mg/1,000 mg Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride. Segluromet 7.5 mg/1,000 mg Each tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Segluromet 2.5 mg/1,000 mg Pink, 19.1 x 10.6 mm oval, film-coated tablet debossed with “2.5/1000” on one side and plain on the other side. Segluromet 7.5 mg/1,000 mg Red, 19.05 x 10.57 mm oval, film-coated tablet debossed with “7.5/1000” on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Segluromet 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: • in patients not adequately controlled on their maximally tolerated dose of metformin alone • in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes • in patients already being treated with the combination of ertugliflozin and metformin as separate tablets. _ _ (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 dose is one tablet twice daily. The dosage should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability using the recommended daily dose of 5 mg or 15 mg of ertugliflozin, while not exceeding the maximum recommended daily dose of metformin. In patients with volume depletion, correcting this condition prior to initiation of Segluromet is recommended (see section 4.4). If a dose is missed, it should be taken as soon as the patient remembers. Pati Pročitajte cijeli dokument