תבנית:תרופה/אנברל 50 מ"ג תמיסה להזרקה - Enbrel 50 mg solution for injection: הבדלים בין גרסאות

מתוך ויקיתרופות
קפיצה אל: ניווט, חיפוש
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מ (יצירת תבנית תרופה)
מ (החלפת טקסט – "עלון לצרכן ערבית" ב־"עלון לצרכן ערבית - نشرة للمستهلك باللغة العربية")
 
(45 גרסאות ביניים של 3 משתמשים אינן מוצגות)
שורה 2: שורה 2:
 
|שם בעברית={{{שם בעברית|אנברל 50 מ"ג תמיסה להזרקה}}}
 
|שם בעברית={{{שם בעברית|אנברל 50 מ"ג תמיסה להזרקה}}}
 
|שם באנגלית={{{שם באנגלית|Enbrel 50 mg solution for injection}}}
 
|שם באנגלית={{{שם באנגלית|Enbrel 50 mg solution for injection}}}
|מרכיב פעיל=
+
|מרכיב פעיל={{רווח קשיח}}
{{{מרכיב פעיל|*[[מרכיב פעיל::Etanercept]] 50 MG/DOSE {{כ}}[[ATC code 5::L04AB01]]
+
*[[Etanercept]] 50 MG / 1 ML {{כ}}[[L04AB01]]
*[[מרכיב פעיל::Etanercept]] 50 MG/DOSE {{כ}}[[ATC code 5::L04AB01]]
+
|קבוצה פרמקולוגית (ATC)={{ATC משרד הבריאות|L04AB|Tumor necrosis factor alpha (TNF-α) inhibitors}}
*[[מרכיב פעיל::Tumor necrosis factor alpha (tnf-a) inhibitors]] L04AB {{כ}}[[ATC code 5::L04AB01]]
+
|צורת מתן=תת-עורי - S.C
*[[מרכיב פעיל::5010981002899]] לא {{כ}}[[ATC code 5::L04AB01]]
+
|צורת מינון=תמיסה להזרקה, SOLUTION FOR INJECTION{{ש}}למניעת מינון יתר או הרעלה יש ליטול את התרופה בהתאם למינון המומלץ כפי שמופיע בעלון לצרכן
*[[מרכיב פעיל::5010981002899]] לא {{כ}}[[ATC code 5::L04AB01]]
+
|סל הבריאות=כלול בסל
*[[מרכיב פעיל::5010981002653]] לא {{כ}}[[ATC code 5::L04AB01]]
+
|במרשם=כן
*[[מרכיב פעיל::Birkendorfer st.65,]] 88397 BIBERACH AN DER RISS, GERMANY Pre-filled syringe: manufacture of drug substance, 50 mg/ml process intermediate, and drug product; visual inspection of prefilled syringes; release of drug substance, 50 mg/ml process intermediate and drug product; stability testing of drug substance, 50 mg/ml process intermediate, and drug product {{כ}}[[ATC code 5::L04AB01]]
+
*[[מרכיב פעיל::Grange castle business park, clondalkin, dublin]] 22, IRELAND Pre-filled pen: Manufacture of drug substance, 50mg/mL process intermediate, Release Testing and Stability Testing of drug substance, 50mg/mL process intermediate and drug product, stability testing of pre-filled pens , Pre-filled syringe: Manufacture of drug substance, 50 mg/ml process intermediate, Release testing and stability testing of drug substance, 50 mg/ml process intermediate and drug product {{כ}}[[ATC code 5::L04AB01]]
+
*[[מרכיב פעיל::Rijksweg]] 12 , B-2870 PUURS, BELGIUM Manufacture of drug product pre-filled syringes; quality control testing of drug product pre-filled syringes with the exception of Apoptosis Bioassay and receptor binding assay {{כ}}[[ATC code 5::L04AB01]]
+
*[[מרכיב פעיל::No.313-1, sec.2, nanshan rd., luzhu shiang taoyuan country, taiwan]] pre-filled pen: Assembly of the pre-filled pens {{כ}}[[ATC code 5::L04AB01]]
+
*[[מרכיב פעיל::Schuetzenstrasse]] 87 D-88212 RAVENSBURG,GERMANY pre-filled syringe: Release Testing of drug product; Stability Testing of drug product; Visual inspection of pre-filled syringes {{כ}}[[ATC code 5::L04AB01]]
+
*[[מרכיב פעיל::Helmut - vetter - st.]] 10, 88213 RAVENSBURG, GERMANY pre-filled syringe: Visual inspection {{כ}}[[ATC code 5::L04AB01]]
+
*[[מרכיב פעיל::Holbeinstrasse]] 40, D-88212 RAVENSBURG, GERMANY pre-filled syringe: Stability Testing of drug product; Visual inspection of pre-filled syringes {{כ}}[[ATC code 5::L04AB01]]
+
*[[מרכיב פעיל::Eisenbahnstrasse]] 2 - 4 , 88085 LANGENARGEN, GERMANY Pre-filled syringe: Manufacture of pre-filled syringes; Release Testing of drug product; Stability Testing of drug product; Visual inspection of pre-filled syringes {{כ}}[[ATC code 5::L04AB01]]
+
*[[מרכיב פעיל::Mooswiesen]] 2, D - 88214 RAVENSBURG, GERMANY pre-filled pen: Assembly of the pre-filled pens; Release Testing of pre-filled pens; Stability Testing of pre-filled pens , pre-filled syringe: Visual inspection {{כ}}[[ATC code 5::L04AB01]]
+
*[[מרכיב פעיל::New lane, havant, hampsire, p09]] 2NG, UK pre-filled pen: Labeling, packaging, storage & distribution of product, batch release by qualified person of pre-filled pens , pre-filled syringe: Labeling, packaging, storage and distribution of Enbrel, Batch release of Enbrel by Qualified Person {{כ}}[[ATC code 5::L04AB01]]
+
*[[מרכיב פעיל::Etanercept]] 50 MG/DOSE {{כ}}[[ATC code 5::L04AB01]]}}}
+
|קבוצה פרמקולוגית (ATC)=
+
{{{קבוצה פרמקולוגית|[[ATC code 4:: L04AB| ]]{{ATC משרד הבריאות|L04AB|Tumor necrosis factor alpha (TNF-α) inhibitors}}}}}
+
|צורת מתן={{{צורת מתן|S.C}}}
+
|צורת מינון={{{צורת מינון|SOLUTION FOR INJECTION}}}
+
|סל הבריאות={{{סל הבריאות|[[#נתוני סל|כלול בסל]]}}}
+
|במרשם={{{במרשם|כן}}}
+
 
|התוויה={{{התוויה|<div style="direction:ltr;">* Rheumatoid arthritis:Enbrel is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless contraindicated) has been inadequate.. Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.* Psoriatic arthritisTreatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease.* Ankylosing spondylitisTreatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. * Plaque psoriasis Treatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.* Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.* Juvenile idiopathic arthritisTreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.* Axial spondyloarthritis* Ankylosing spondylitis(AS)Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.* Non-radiographic axial spondyloarthritisTreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs)</div>}}}
 
|התוויה={{{התוויה|<div style="direction:ltr;">* Rheumatoid arthritis:Enbrel is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless contraindicated) has been inadequate.. Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.* Psoriatic arthritisTreatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease.* Ankylosing spondylitisTreatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. * Plaque psoriasis Treatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.* Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.* Juvenile idiopathic arthritisTreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.* Axial spondyloarthritis* Ankylosing spondylitis(AS)Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.* Non-radiographic axial spondyloarthritisTreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs)</div>}}}
|התאמת מינון={{{התאמת מינון|https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Rishum_4_54347217.pdf#page=2}}}
+
|שם יצרן=[[WYETH PHARMACEUTICALS (HAVANT), UK]]
|התוויות נגד={{{התוויות נגד|https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Rishum_4_54347217.pdf#page=4}}}
+
|שם יצרן מקוצר=[[WYETH]]
|פרמקודינמיקה={{{פרמקודינמיקה|https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Rishum_4_54347217.pdf#page=15}}}
+
|שם בעל הרישום=[[PFIZER PHARMACEUTICALS ISRAEL LTD]]
|פרמקוקינטיקה={{{פרמקוקינטיקה|https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Rishum_4_54347217.pdf#page=27}}}
+
|שימוש בהריון והנקה={{{שימוש בהריון והנקה|https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Rishum_4_54347217.pdf#page=9}}}
+
|תגובות בין תרופתיות={{{תגובות בין תרופתיות|https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Rishum_4_54347217.pdf#page=8}}}
+
|תופעות לוואי={{{תופעות לוואי|https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Rishum_4_54347217.pdf#page=10}}}
+
|שם יצרן={{{שם יצרן|[[יצרן::WYETH PHARMACEUTICALS (HAVANT), UK]]}}}
+
|שם יצרן מקוצר=[[שם יצרן מקוצר::WYETH| ]]
+
|שם בעל הרישום={{{שם בעל הרישום|[[בעל רישום::PFIZER PHARMACEUTICALS ISRAEL LTD]]}}}
+
 
|רישיון מתאריך={{{רישיון מתאריך|[[רישום מתאריך::01/2015]]}}}
 
|רישיון מתאריך={{{רישיון מתאריך|[[רישום מתאריך::01/2015]]}}}
|תאריך הגשה={{{תאריך הגשה|[[תאריך הגשה::12/2008]]}}}
+
|תאריך הגשה=12/2008
|קישור למאגר משרד הבריאות1={{{קישור למאגר משרד הבריאות1|{{מסחרי משרד הבריאות|Enbrel 50 mg solution for injection|אנברל 50 מ"ג תמיסה להזרקה}}}}}
+
|קישור למאגר משרד הבריאות1=[https://israeldrugs.health.gov.il/#!/medDetails/142%2053%2031950%2000 אנברל 50 מ"ג תמיסה להזרקה] במאגר משרד הבריאות
|עלון לרופא={{{עלון לרופא|[https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Rishum_4_54347217.pdf עלון לרופא]}}}
+
|עלון לרופא={{רווח קשיח}}
|עלון לצרכן={{{עלון לצרכן|*[https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Rishum_4_54347617.pdf עלון לצרכן]
+
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_548175921.pdf עלון לרופא 13.06.2021]
*[https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Rishum_4_54347517.pdf עלון לצרכן]
+
|עלון לצרכן={{רווח קשיח}}
*[https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Rishum_4_54347317.pdf עלון לצרכן]}}}
+
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_548175221.pdf עלון לצרכן עברית 13.06.2021]
|החמרות לעלון={{{החמרות לעלון|*[https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Enbrel_PFS_PFP_PIL_SPC_worsening_09.2014_1411463189857.doc החמרה לעלון]
+
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_548175021.pdf עלון לצרכן עברית 13.06.2021]
*[https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Enbrel_25mg_PFS_Enbrel_50mg_solution_for_injection_in_PFS_PFP_pil_spc_worsening_Mar.14_1394715292523.doc החמרה לעלון]
+
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_527938421.pdf עלון לצרכן ערבית - نشرة للمستهلك باللغة العربية 31.03.2021]
*[https://www.old.health.gov.il/units/pharmacy/trufot/alonim/Enbrel-25-mgPFS-50-mg-PFS_PFP-31949-31950-form-doctor-patient_1375178748236.doc החמרה לעלון]}}}
+
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_527936621.pdf עלון לצרכן ערבית - نشرة للمستهلك باللغة العربية 31.03.2021]
 +
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_17_440920020.pdf עלון לצרכן ערבית - نشرة للمستهلك باللغة العربية 03.11.2020]
 +
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_527941621.pdf עלון לצרכן אנגלית - Patient information leaflet{{כ}} 31.03.2021]
 +
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_527939721.pdf עלון לצרכן אנגלית - Patient information leaflet{{כ}} 31.03.2021]
 +
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_17_440920320.pdf עלון לצרכן אנגלית - Patient information leaflet{{כ}} 03.11.2020]
 +
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_382540521.pdf עלון לצרכן 03.03.2021]
 +
|החמרות לעלון={{רווח קשיח}}
 +
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_382547421.pdf החמרה לעלון 03.03.2021]
 +
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_356573321.pdf החמרה לעלון 21.01.2021]
 +
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_17_440896020.pdf החמרה לעלון 01.11.2020]
 +
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_14_222004120.pdf החמרה לעלון 29.02.2020]
 +
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_11_492460419.pdf החמרה לעלון 23.06.2019]
 +
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_7_35550818.pdf החמרה לעלון לרופא 12.03.2018]
 +
*[[מדיה:ENBREL 25-50 MG SOLUTION FOR INJECTION - החמרה לעלון - 23.09.2014.pdf|החמרה לעלון 23.09.2014]]
 +
*[[מדיה:ENBREL 25-50 MG SOLUTION FOR INJECTION - החמרה לעלון - 13.03.2014.pdf|החמרה לעלון 13.03.2014]]
 +
*[[מדיה:ENBREL 25-50 MG SOLUTION FOR INJECTION - החמרה לעלון - 30.07.2013.pdf|החמרה לעלון 30.07.2013]]
 
|מספר רישום={{{מספר רישום|142 53 31950 00}}}
 
|מספר רישום={{{מספר רישום|142 53 31950 00}}}
|תאריך עדכון=[[עדכון אחרון::28/08/17]]
+
|תאריך עדכון=[[עדכון אחרון::14/05/19]]
|תמונת אריזה={{{תמונת אריזה|}}}
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|תמונת אריזה=https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_17_377386920.jpg
 
|שיווק הופסק={{{שיווק הופסק|לא}}}
 
|שיווק הופסק={{{שיווק הופסק|לא}}}
|שם ללא מינון={{{שם ללא מינון|אנברל - Enbrel}}}
+
|שם ללא מינון=אנברל - Enbrel
 +
|שם ללא מינון באנגלית‎=Enbrel
 +
|התאמת מינון=
 +
|התוויות נגד=
 +
|פרמקודינמיקה=
 +
|פרמקוקינטיקה=
 +
|שימוש בהריון והנקה=
 +
|תגובות בין תרופתיות=
 +
|תופעות לוואי=
 +
|חיפוש בוויקירפואה=
 
|ללא קטגוריה={{{ללא קטגוריה|<noinclude>-</noinclude>}}}
 
|ללא קטגוריה={{{ללא קטגוריה|<noinclude>-</noinclude>}}}
 
}}
 
}}
 
<noinclude>{{תרופה/תיעוד}}</noinclude>
 
<noinclude>{{תרופה/תיעוד}}</noinclude>

גרסה אחרונה מתאריך 16:17, 7 באפריל 2023



נתוני תרופה
במרשם RxIcon.png
מינונים נוספים
קבוצה פרמקולוגית (ATC4) L04AB
Tumor necrosis factor alpha (TNF-α) inhibitors
מרכיב פעיל (ATC5)  
צורת מתן תת-עורי - S.C
צורת מינון תמיסה להזרקה, SOLUTION FOR INJECTION
למניעת מינון יתר או הרעלה יש ליטול את התרופה בהתאם למינון המומלץ כפי שמופיע בעלון לצרכן
התוויה
* Rheumatoid arthritis:Enbrel is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless contraindicated) has been inadequate.. Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.* Psoriatic arthritisTreatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease.* Ankylosing spondylitisTreatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. * Plaque psoriasis Treatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.* Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.* Juvenile idiopathic arthritisTreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.* Axial spondyloarthritis* Ankylosing spondylitis(AS)Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.* Non-radiographic axial spondyloarthritisTreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs)
תבנית:נתוני סל/תרופה/אנברל 50 מ"ג תמיסה להזרקה - Enbrel 50 mg solution for injection
עלון לרופא והחמרות לעלון

 

 

עלון לצרכן  
ערכים בוויקירפואה ערכים קשורים בוויקירפואה
אנברל 50 מ"ג תמיסה להזרקה במאגר משרד הבריאות
חיפוש מאמרים -
מידע ברשת -
שם יצרן WYETH PHARMACEUTICALS (HAVANT), UK
שם בעל הרישום PFIZER PHARMACEUTICALS ISRAEL LTD
רישיון תאריך הגשה: 12/2008. רישיון מתאריך: 01/2015
תאריך עדכון אחרון 14/05/19
תמונת אריזה

תמונת אריזה

תאריך עדכון: 14/05/19 WYETH

אנברל - Enbrel true



דף זה נוצר על ידי בוט ומגדיר תבנית עם פרטי התרופה.

{{תרופה/אנברל 50 מ"ג תמיסה להזרקה - Enbrel 50 mg solution for injection}}

ב:

{{תרופה/אנברל 50 מ"ג תמיסה להזרקה - Enbrel 50 mg solution for injection
| שם הפרמטר=ערך חדש (דורס את הערך שהבוט הגדיר)
}}