ג'ארדיאנס 25 מג

국가: 이스라엘

언어: 히브리어

출처: Ministry of Health

유효 성분:

EMPAGLIFLOZIN

제공처:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC 코드:

A10BD19

약제 형태:

טבליות מצופות פילם

구성:

EMPAGLIFLOZIN 25 MG

관리 경로:

פומי

처방전 유형:

מרשם נדרש

Manufactured by:

BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY

치료 영역:

LINAGLIPTIN AND EMPAGLIFLOZIN

제품 요약:

התרופה תינתן לטיפול במקרים האלה:א. סוכרת בחולי סוכרת סוג 2 בחולים העונים על כל אלה:1. HbA1c בערך 7.0% ומעלה, על אף טיפול קודם למחלתם. 2. eGFR בערך 30 מ""ל/דקה/1.73 מ""ר ומעלה, או בערך גבוה יותר בהתאם לתנאי הרישום.3. אבחנה של אחד מאלה:א. אוטם בשריר הלב ב. ניתוח מעקפים (CABG)ג. מחלת לב איסכמית.ד. מחלת כליה כרונית המוגדרת כאחד מאלה, בהתאם לתנאי הרישום:1. יחס קראיטינין / אלבומין מעל 30 מ""ג/גרם.2. eGFR נמוך מ-60 מ""ל/דקה.ב. חולי אי ספיקת לב תסמינית (דרגות תפקוד NYHA II-IV) אשר נותרו סימפטומטיים למרות מיצוי טיפול מיטבי למחלתם. לעניין זה טיפול מיטבי יכלול תרופות ממשפחת מעכבי RAS (מעכבי ACE, משפחת ARB) וחוסמי בטא.

승인 날짜:

2020-07-31

환자 정보 전단

Inactive ingredients and allergens in the medicine - see section
2 'Important information about some of the ingredients of the
medicine' and section 6 ‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, contact your physician
or pharmacist. This medicine has been prescribed for treating
your illness. Do not pass it on to others. It may harm them, even
if it seems to you that their illness is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Jardiance is indicated for:
•
improvement of blood sugar level control in adults with
type 2 diabetes, along with diet and exercise.
•
reducing the risk of cardiovascular death in adults with type
2 diabetes and established cardiovascular disease.
•
JARDIANCE 10 MG is intended to reduce the risk of
cardiovascular death and hospitalization for heart failure in
adults with heart failure.
Jardiance is not indicated for the treatment of type 1 diabetes or
diabetic ketoacidosis.
Jardiance is not recommended for use to improve glycemic
control in adults with type 2 diabetes mellitus and estimated
glomerular filtration rate (eGFR) less than 30 ml/min/1.73m
2
.
THERAPEUTIC GROUP: SGLT2 (sodium-glucose co-transporter 2)
inhibitors.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient
empagliflozin or to any of the additional ingredients
that the medicine contains (please refer to section
6 – ‘Additional information’, for the list of inactive
ingredients). Symptoms of a serious allergic reaction to
Jardiance may include:
o swelling of your face, lips, throat or other areas of your
skin
o difficulty with swallowing or breathing
o raised, red areas on your skin (hives)
If you experience any of the symptoms on the list, stop
taking Jardiance and contact your physician right away or
go to the nearest hospital emergency room.
•
You are on dialysis.
SPECIAL WARNINGS REGARDING THE