זולטופיי - Xultophy

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×§×××¦× ×¤×¨××§××××××ª (ATC4)

A10AE
Insulins and analogues for injection, long-acting

××¨××× ×¤×¢×× (ATC5)

Insulin degludec 100 U/ML âA10AE56
Liraglutide 3.6MG/ML âA10AE56

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×ª×ª-×¢××¨× - S.C

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×ª×××¡× ××××¨×§×, SOLUTION FOR INJECTION
××× ××¢×ª ××× ×× ××ª×¨ ×× ××¨×¢×× ××© ××××× ××ª ××ª×¨××¤× ×××ª×× ×××× ×× ××××××¥ ××¤× ×©×××¤××¢ ××¢××× ××¦×¨××

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XultophyÂ® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to other oral medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control, and the population studied, see sections 4.4, 4.5 and 5.1

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11/01/2018

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××ª××××	×ª××¨×× ×××××	×ª××× ×§××× ×	Class Effect	××¦× ××××	××¡××¡ ××××××ª
×××¤×× ××××× ×¡×××¨×ª ×¡×× 2 ××¢×× ×× ×¢× ×× ×××: ×. ×¢×¨× HbA1c 7.5% ×××¢×× ××¢×× ×× ×¢× ××× ××××: 1. ×¢× BMI ××¢×¨× 28 ×××¢××; 2. ×¢× BMI ××¢×¨× 25 ×××¢××, ×××××× ×××× ×××××× â ××××ª ×× ××××××ª, ×××× ×¡×¨××¨×××¡×§×××¨××ª, ××××ª ×××× ××¨×× ××ª, ××××ª ××× ×× ×¤×¨××¤×¨××ª - (PVD - Peripheral vascular disease). ×. ×× ×¡××× ××¢××¨ ××¤× ×§×¨××××××¡; ×. ××× × ×¡××××× ××× ×¡×¤××§× ×××××ª××ª (×§×¨×××× ×× ××¢× 1.5); ×. ××××¨ ×××¦×× ××××¤×× ××ª×¨××¤×ª× ××©×ª× ×ª×¨××¤××ª ×¤×××××ª, ××× ××¤×××ª.	03/01/2021	×× ×××§×¨×× ××××××	LIRAGLUTIDE, LIXISENATIDE, DULAGLUTIDE, EXENATIDE	×¡×××¨×ª ×¡×× 2, Diabetes
×××¤×× ××××× ×¡×××¨×ª ×¡×× 2 ××¢×× ×× ×¢× ×× ×××: 1. ××¢×× ×× ×¢× ××× ××××: ×. BMI ××¢× 30 ×-HbA1c ××¢× 7.5%; ×. BMI ××× 28-30 ×-HbA1c ××¢× 9.0%; ×. BMI ××× 28-30 ×-HbA1c ××× 7.5 ×-9.0% ×××××× ×××× ×××××× â ××××ª ×× ××××××ª, ×××× ×¡×¨××¨×××¡×§×××¨××ª, ××××ª ×××× ××¨×× ××ª. 2. ×× ×¡××× ××¢××¨ ××¤× ×§×¨××××××¡; 3. ××× × ×¡××××× ××× ×¡×¤××§× ×××××ª××ª (×§×¨×××× ×× ××¢× 1.5); 4. ××××¨ ×××¦×× ××××¤×× ××ª×¨××¤×ª× ××©×ª× ×ª×¨××¤××ª ×¤×××××ª, ××× ××¤×××ª.	11/01/2018	×× ×××§×¨×× ××××××	LIRAGLUTIDE, LIXISENATIDE, DULAGLUTIDE, EXENATIDE	×¡×××¨×ª ×¡×× 2, Diabetes

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××ª×¨××¤××ª ××× ×ª× × ××××¤×× ××××× ×¡×××¨×ª ×¡×× 2 ××¢×× ×× ×¢× ×× ×××:

×¢×¨× HbA1c 7.5% ×××¢×× ××¢×× ×× ×¢× ××× ××××:
1. ×¢× BMI ××¢×¨× 28 ×××¢××
2. ×¢× BMI ××¢×¨× 25 ×××¢××, ×××××× ×××× ×××××× â ××××ª ×× ××××××ª, ×××× ×¡×¨××¨×××¡×§×××¨××ª, ××××ª ×××× ××¨×× ××ª, ××××ª ××× ×× ×¤×¨××¤×¨××ª - (PVD - Peripheral vascular disease)
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××× × ×¡××××× ××× ×¡×¤××§× ×××××ª××ª (×§×¨×××× ×× ××¢× 1.5)

×¢××× ××¨××¤× ×××××¨××ª ××¢×××

×¢××× ××¨××¤× 23.11.2020

××××¨× ××¢××× 13.01.2021

×¢××× ××¦×¨××	Â ×¢××× ××¦×¨×× ×¢××¨××ª 30.11.2020 ×¢××× ××¦×¨×× ×¢×¨×××ª - ÙØ´Ø±Ø© ÙÙÙØ³ØªÙÙÙ Ø¨Ø§ÙÙØºØ© Ø§ÙØ¹Ø±Ø¨ÙØ© 30.11.2020 ×¢××× ××¦×¨×× ×× ××××ª - Patient information leafletâ 30.11.2020

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×××¤××© ××××¨××	××××¨×× ×-PubMed
××××¢ ××¨×©×ª	RxList WebMD Drugs.com
×©× ××¦×¨×	NOVO NORDISK A/S, DENMARK
×©× ××¢× ××¨××©××	NOVO NORDISK LTD, ISRAEL
×¨××©×××	×ª××¨×× ×××©×: 09/2015. ×¨××©××× ××ª××¨××: 03/2016
×ª××¨×× ×¢×××× ×××¨××	15/05/19

השינוי האחרון נעשה בֹ־6 באוקטובר 2024 ב־01:40

זולטופיי - Xultophy

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