GLYXAMBI 25 MG5 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

EMPAGLIFLOZIN; LINAGLIPTIN

Tilgængelig fra:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC-kode:

A10BD19

Lægemiddelform:

FILM COATED TABLETS

Sammensætning:

LINAGLIPTIN 5 MG; EMPAGLIFLOZIN 25 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY

Terapeutisk område:

LINAGLIPTIN AND EMPAGLIFLOZIN

Terapeutiske indikationer:

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.

Autorisation dato:

2021-02-28

Indlægsseddel

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

Produktets egenskaber

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