Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
EMPAGLIFLOZIN; LINAGLIPTIN
BOEHRINGER INGELHEIM ISRAEL LTD.
A10BD19
FILM COATED TABLETS
LINAGLIPTIN 5 MG; EMPAGLIFLOZIN 25 MG
PER OS
Required
BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY
LINAGLIPTIN AND EMPAGLIFLOZIN
GLYXAMBI tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate. Limitations of UseGLYXAMBI is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.GLYXAMBI has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using GLYXAMBI.
2021-02-28
יאמ 2023 Glyxambi 10mg/5mg Glyxambi 25mg/5mg יבמסקילג 10 /ג"מ 5 ג"מ יבמסקילג 25 /ג"מ 5 ג"מ empagliflozin 10 mg and linagliptin 5 mg empagliflozin 25 mg and linagliptin 5 mg coated tablets - film coated tablets - film וכדע :ןודנה ן םינולע ,ה/רקי ת/חקור ,ה/רקי ה/אפור וכדע לע םכעידוהל תשקבמ מ"עב לארשי םייהלגניא רגנירוב תרבח ן אפורל ןולעב ןכרצל ןולעבו רישכתה לש םי .ןודנב יוותהה תו מושרה תו רישכתל םי לארשיב : GLYXAMBI tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate. Limitations of Use GLYXAMBI is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. GLYXAMBI has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using GLYXAMBI. .הטמ ונמוס םינולעב רתויב םייתועמשמה םייונישה רבסה : יתחת וק םע טסקט .ןולעל ףסוהש טסקט ןייצמ .ןולעה ןמ רסוהש טסקט ןייצמ הצוח וק םע טסקט ןולעבו אפורל ןולעב ןייעל שי ףסונ עדימל םירשואמה ןכרצל . תואירבה דרשמ רתאבש תופורתה רגאמב םוסרפל ו חלשנ םינכדועמה םינולעה . לע םלבקל ןתינ , ןכ ומכ - םושירה לעבל היינפ ידי : םידוהיה תנידמ 'חר ,מ"עב לארשי םייהלגניא רגנירוב 89 ןופלטבו ,חותיפ הילצרה 09-9730500 ה כ ר ב ב , תב - ןהכ הכלמ לא הנוממ תחקור רוב ארשי םייהלגניא רגני ל םינוכדע םייתוהמ אפורל ןולעב ףיעסב WARNINGS AND PRECAUTIONS . 8 :אבה עדימה ן Přečtěte si celý dokument
Glyxambi Updated Prescribing Information 10 / 5 mg, 25 / 5 mg May 2023 Boehringer Ingeheim Israel Page 1 of 27 GLYXAMBI ® 10MG/5MG GLYXAMBI ® 25MG/5MG PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT Glyxambi 10mg/5mg Glyxambi 25mg/5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glyxambi 10 mg/5mg :The active ingredients are empagliflozin 10 mg and linagliptin 5 mg. Glyxambi 25 mg/5mg :The active ingredients are empagliflozin 25 mg and linagliptin 5 mg. For the full list of excipients, see section "DESCRIPTION" below. 3 PHARMACEUTICAL FORM Film coated tablets 4 INDICATIONS AND USAGE 4.1 Indication GLYXAMBI tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate [see Clinical Studies (16)]. 4.2 Limitations of Use GLYXAMBI is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis [see Warnings and Precautions (8.4)]. GLYXAMBI has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using GLYXAMBI [see Warnings and Precautions (8.1)]. 5 DOSAGE AND ADMINISTRATION 5.1 Prior to Initiation of GLYXAMBI Assess renal function before initiating GLYXAMBI and as clinically indicated [see Warnings and Precautions (8.3)]. In patients with volume depletion, correct this condition before initiating GLYXAMBI [see Warnings and Precautions (8.3) and Use in Specific Populations (11.5, 11.6)]. 5.2 Recommended Dosage The recommended dose of GLYXAMBI is 10 mg empagliflozin/5 mg linagliptin once daily in the morning, taken with or without food. In patients tolerating GLYXAMBI, the dose may be increased to 25 mg empagliflozin/5 mg linagliptin once daily for additional glycemic control.. Glyxambi Updated Prescribing Information 10 / 5 mg, 25 / 5 mg May 2023 Boehringer Ingeheim Israel Page 2 of 27 No studies have Přečtěte si celý dokument