تريتايس كومب ٢٫٥ ملغم/١٢٫٥ ملغ

المعلومات الرئيسية

  • اسم تجاري:
  • تريتايس كومب ٢٫٥ ملغم/١٢٫٥ ملغ
  • الشكل الصيدلاني:
  • TABLETS
  • طريقة التعاطي:
  • PER OS
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • SANOFI - AVENTIS S.P.A., ITALY

المستندات

الأقلمة

  • متاح في:
  • تريتايس كومب ٢٫٥ ملغم/١٢٫٥ ملغ
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • RAMIPRIL AND DIURETICS
  • الخصائص العلاجية:
  • Essential hypertension. Tritace comp is indicated in patients whose blood pressure cannot be adequately lowered with ramipril alone.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 122273018700
  • تاريخ الترخيص:
  • 01-04-2011
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة: نشرة المعلومات, خصائص المنتج

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986

The dispensing ofthis medicine requires a doctor's prescription

Read this package insert carefully in its entirety before using this medicine

The format ofthis leaflet was determined by the Ministry ofHealth and its content was checked and approved in November 2010

TRITACE COMP TRITACE COMP

2.5 mg/12.5 mg 5 mg/25 mg

Tablets Tablets

Composition:

Each tablet contains: Each tablet contains:

Ramipril 2.5 mg Ramipril 5 mg

Hydrochlorothiazide12.5 mg Hydrochlorothiazide25 mg

Inactive ingredients:Pregelatinized starch, Microcrystalline cellulose, Hydroxypropylmethylcellulose, Sodium stearyl fumarate.

Therapeutic group:ACE inhibitor + thiazide diuretic.

Therapeutic activity:For treatment ofhigh blood pressure

When should the preparation not be used?

Do not use this preparation in the last six months ofpregnancy or ifyou are breastfeeding.

DonotuseifthereisaknownsensitivitytoramiprilortoanyotherACEinhibitorusedtolowerbloodpressureortohydrochlorothiazide

or to other thiazide diuretics or to sulfonamides or to any ingredients ofthe medicine.

Do not use ifyou have ever had a severe allergic reaction called angioedema.

Do not use ifyou suffer from a problem in blood supply to the kidneys - renal artery stenosis.

Do not use ifyou are undergoing dialysis or any other type ofblood filtration.

Do not use ifyou suffer from severe kidney function impairment.

Do not use ifyou suffer from severe liver function impairment.

Donotuseifyousufferfromdisturbancesinthelevelofsalts,e.g.:lowbloodpotassiumorsodiumorpatientswithhypercalcemia.

Do not take this medicine without consulting a doctor before starting treatment:

Ifyousufferfrom:heart,liverorkidneyproblems;lossofsaltsorfluids(asaresultofvomiting,diarrhea,excessivesweating,low

saltdiet,takingdiureticsforaprolongedperiodorifyouhaveundergonedialysis);ifyouareabouttoundergotreatmenttoreduce

allergytobeeorwaspstings(desensitization);ifyouareabouttoreceiveanestheticsforsurgeryordentaltreatment;ifyourblood

potassiumlevelishigh;ifyousufferfromconnectivetissuediseasessuchassclerodermaorsystemiclupuserythematosus;ifyouare

pregnant, planning to become pregnant.

How will this medicine affect your daily life?

Useofthismedicinemayimpairalertness,andcautionshouldthereforebeexercisedwhendrivingacar,operatingdangerous

machinery and in any activity which requires alertness.

Do not drink wineor alcoholic beverages while under treatment with this medicine, especially at the start oftreatment.

Tritace Compcan interfere with results ofparathyroid function or anti-doping tests.

Drug interactions:

Ifyouaretakinganotherdrug,includingnon-prescriptionmedicinesandfoodsupplements,orifyouhavejustfinishedtreatmentwith

another medicine, inform the attending doctor, in order to prevent hazards or lack ofefficacy arising from drug interactions.

Combination with the following medicines can reduce the effectiveness ofTritace Comp:

Medicinestorelievepainandinflammation(forexample,NSAIDssuchasibuprofenorindomethacinandaspirin);medicinestotreat

low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, noradrenalin or adrenalin.

Combination with the following medicines can increase the risk ofside effects:

Medicinestorelievepainandinflammation(forexample,NSAIDssuchasibuprofenorindomethacinandaspirin);medicinesthat

mayloweryourbloodpotassiumlevelsuchasmedicinesforconstipation,diuretics,amphotericinB(givenforfungalinfections),and

ACTHgiventotestadrenalglandfunction;medicinestotreatcancer(chemotherapy);medicinesforheartproblemssuchasmedicines

totreatarrhythmias;medicinestopreventrejectionoforgantransplantssuchascyclosporin;diureticssuchasfurosemide;medicines

thatcanraisethebloodpotassiumlevelsuchasspironolactone,triamterene,amiloride,potassiumsaltsandheparin;steroidsfor

treatmentofinflammationsuchasprednisoneorprednisolone;calciumsupplements;allopurinol(giventoreducethelevelofuric

acidintheblood);procainamide(givenfortreatmentofheartrhythmproblems);cholestyramine(tolowertheamountoflipidsin

your blood); carbamazepine (for epilepsy).

CombiningTritace Compwith the following medicines can affect their action:

Medicinesfordiabetessuchasoralmedicinesandinsulin-TritaceCompmayreduceyourbloodsugarlevel,monitoryourblood

sugarlevelstrictlywhentakingTritaceComp;lithium(givenfortreatmentofmentalproblems)-TritaceCompcancauseanelevated

leveloflithiumintheblood,thedoctormustmonitorlithiumlevelscarefullywhileyouaretakingTritaceComp;musclerelaxants;

quinineformalaria;medicinescontainingiodinecanbegivenifyouareundergoingscanningorX-rayinahospital;penicillin(for

infections); oral blood thinning medicines such as warfarin.

Side effects:

As with all medicines,Tritace Compcan cause side effects. These effects do not occur in everyone taking the medicine.

StoptreatmentwithTritaceCompandrefertothedoctorimmediatelyifyouexperienceanyofthefollowingserioussideeffects

-youmayrequireurgentmedicaltreatment:swellingoftheface,lipsorthroatwhichmakeitdifficulttoswalloworbreathe,aswell

astinglingandrash-thesecouldbesignsofasevereallergicreactiontoTritaceComp;severeskinreactionincludingrash,mouth

ulcers,worseningofapre-existingskindisease,reddening,blisteringordetachmentofskin(suchasStevens-Johnsonsyndrome,toxic

epidermal necrolysis or erythema multiforme).

Tellyourdoctorimmediatelyifyouexperienceanyofthefollowingsideeffects:increasedheartrate,strongandirregularheartbeat

(palpitations),chestpain,tightnessinyourchestoramoreseriousproblemsuchasheartattackorstroke;shortnessofbreath,coughing

orfeverlasting2-3daysandreducedappetite-thesecouldbesignsofalungproblem;bruisingmoreeasily,bleedingforlongerthan

normal,anysignofbleeding(e.g.,bleedingfromthegums),bluemarksontheskinorgettinginfectionsmoreeasilythanusual,sore

throatandfever,feelingtired,faint,dizzyorhavingpaleskin-thesecanbesignsofbloodorbonemarrowproblems;severeabdominal

painwhichmayradiatetotheback-thiscouldbeasignofpancreatitis;fever,chills,tiredness,lossofappetite,abdominalpain,nausea,

yellowing ofthe skin or eyes (jaundice) - these can be signs ofliver problems such as inflammation ofthe liver or liver damage.

Other side effects include:

Please tell your doctor ifany ofthe following effects becomes serious or lasts longer than a few days.

Commoneffects(occurringinlessthan1in10people):headacheorfeelingtiredorweak;feelingdizzy-thisismorelikelytohappen

atthebeginningofTritaceComptreatmentorwhenthedosageisraised;drycoughorbronchitis;bloodtestsshowinghigherblood

sugarlevelsthanusual-ifyouhavediabetesthismayexacerbateyourdisease;bloodtestsshowinghigheruricacidorlipidlevels

than usual; pain, redness and swelling ofthe joints.

Uncommoneffects(occurringinlessthan1in100people):skinrashwithorwithoutraisedareas;flushing,fainting,lowbloodpressure,

particularlywhenstandinguporsittingupquickly;balanceproblems;itchingorunusualskinsensationssuchasstinging,numbness

ortingling;lossoforchangeinthesenseoftaste;sleepproblems;feelingdepressed,anxious,morenervousthanusualorrestless;

blockednose,sinusitis,difficultybreathing;inflamedgums,swollenmouth;theeyes-redness,itching,swellingortearing;ringingin

theears;blurredvision;hairloss;chestpain;musclepain;constipation,abdominalpain;indigestionorfeelingsick;urinatingmore

thanusual;sweatingmorethanusualorfeelingthirsty;lossoforreducedappetite;increaseorchangeintheheartrate;swellingof

thearmsandlegs-maybeasignofthebodyretainingmorefluidsthanusual;fever;impotenceinmen;bloodtestresultsshowinga

reductioninthenumberofredbloodcells,whitebloodcellsorplateletsorintheamountofhemoglobin;bloodtestresultsindicating

changes in function ofthe liver, pancreas or kidneys; blood test results showing a lower blood potassium level than usual.

Veryrareeffects(occurringinlessthan1in10,000people):vomiting,diarrheaorheartburn;rednessorswellingofthetongueor

dry mouth; blood test results showing a higher blood potassium level than usual.

Other side effects reported:

Please tell your doctor ifany ofthe following effects becomes serious or lasts longer than a few days.

Difficultyconcentrating,feelingrestlessorconfused;changeofcolorinthefingersandtoeswhenyouarecoldandthenstinging

orpainwhenyouwarmup(Raynaud'sphenomenon);breastenlargementinmen;bloodclots;hearingdisturbances;conjunctival

dryness;objectsappearingyellow;dehydration;swelling,painorrednessofthecheeks(inflammationofthesalivaryglands);

intestinalangioedemamanifestedbyabdominalpain,vomitingordiarrhea;increasedsensitivitytosunlight;severepeelingofthe

skin,stinging,lumpyrashorotherskinproblemssuchasreddishrashofthefaceorforehead;skinrashorbruises;blotchesonthe

skinandsensationofcoldintheextremities;nailproblems(forinstancelooseningordetachmentofthenailsfromtheirbed);muscle

1986- ו"משתה )םירישכת( םיחקורה תונקת יפל ןכרצל ןולע

אפור םשרמב תבייח וז הפורת

הפורתב י/שמתשת םרטב ופוס דע ןולעה תא ןויעב י/ארק

2010רבמבונב רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ

פמוק סייטירט פמוק סייטירט

ג"מ 25/ ג"מ 5 ג"מ 12.5/ ג"מ 2.5

תוילבט תוילבט

:בכרה

:הליכמ הילבט לכ :הליכמ הילבט לכ

Ramipril 5 mg Ramipril 2.5mg

Hydrochlorothiazide25 mg Hydrochlorothiazide12.5 mg

:םיליעפ יתלב םירמוח

Pregelatinized starch, Microcrystalline cellulose, Hydroxypropylmethylcellulose, Sodium stearyl fumarate.

.ידיזאית ןתשמ + ACE בכעמ:תיטיופרת הצובק

.םד ץחל רתיב לופיטל:תיאופר תוליעפ

?רישכתב שמתשהל ןיא יתמ

.הקינימ ךניה םא וא םינורחאה ןוירהה ישדוח תששב רישכתב שמתשהל ןיא

דיזאיתורולכורדיהלואםדץחלתדרוהלםישמשמה ACE יבכעמתצובקמרחארישכתלואלירפימרלתושיגרהעודיםאשמתשהלןיא

.הפורתה יביכרממ דחאל וא םידימאנופלוסל וא םירחא םינתשמ םידיזאיתל וא

.angioedema - תארקנה הרומח תיגרלא הבוגתמ רבעב תלבס םא שמתשהל ןיא

.renal artery stenosis - הילכל םד תקפסאב היעבמ ת/לבוס ךניה םא שמתשהל ןיא

.םד ןוניס לש רחא גוס וא הזילאיד ת/רבוע ךניה םא שמתשהל ןיא

.הילכה דוקפתב רומח יוקילמ ת/לבוס ךניה םא שמתשהל ןיא

.דבכה דוקפתב רומח יוקילמ ת/לבוס ךניה םא שמתשהל ןיא

ןדיסלשףדועםעםילוחואםדבתוכומנןרתנואןגלשאתומר:ןוגכםיחלמהתמרבתוערפהמת/לבוסךניהםאשמתשהלןיא

.םדב

:לופיטה תלחתה ינפל אפורב ץעוויהל ילבמ הפורתב שמתשהל ןיא

,םיחלמתלדהטאיד,תרבגומהעזה,לושלש,האקהתובקעב(םילזונואםיחלמדוביא;הילכבואדבכב,בלבתויעב:מת/לבוסךניהםא

ואםירובדתוציקעלהיגרלאהתתחפהללופיטרובעלת/דמועךניהםא;)הזילאידתרבעםאואתכשוממהפוקתלםינתשמתליטנ

ךניהםא;ההובגךמדבןגלשאהתמרםא;םיינישלופיטבואחותינבהמדרהירמוחלבקלת/דמועךניהםא;)היצזיטיסנסד(תוערצ

.ןוירה תננכתמ ,ןוירהב ךניה םא ;) systemic lupus erythematosus ( תבאז וא המרדורלקס ןוגכ רוביחה תמקר תולחממ ת/לבוס

?ךלש םוי םויה ייח לע הפורתה עיפשת ךיא

תבייחמהתוליעפלכבותונכוסמתונוכמתלעפהב,בכרבהגיהנבתוריהזבייחמןכלעותונריעבםוגפללולעוזהפורתבשומישה

.תונריע

.לופיטה תליחתב דחוימבו הפורתה םע לופיטה תפוקתב םיפירח תואקשמ ואתוניי תותשל ןיא

.anti-doping תקידב לע וא דיאוריתאראפה דוקפת תקידב תואצות לע עיפשהל לוכיפמוק סייטירט

:תויתפורת-ןיב תובוגת

,תרחאהפורתבלופיטהתעהזתרמגםאוא,הנוזתיפסותואפורםשרמאללתורכמנהתופורתללוכ,תפסונהפורתת/לטונךניהםא

.תויתפורת-ןיב תובוגתמ םיעבונה תוליעי-יא וא םינוכיס עונמל ידכ לפטמה אפורל חוודל ךילע

:פמוק סייטירטה תוליעי תתחפהל םורגל לוכי תואבה תופורתה םע בוליש

תקיפסיא,קוש,ךומנםדץחלבלופיטלתופורת;)ןיריפסאוןיצאתמודניאואןפורפוביאומכ NSAID אמגודל(תקלדובאכבהלקהלתופורת

.ןילנרדא וא ןילנרדארונ ,ןירדפא ומכ תויגרלא וא המתסא ,בל

:יאוול תועפותל יוכיסה תרבגהל םורגל לוכי תואבה תופורתה םע בוליש

ןגלשאהתמרתאתיחפהלתולולעהתופורת;)ןיריפסאוןיצאתמודניאואןפורפוביאומכ NSAID אמגודל(תקלדובאכבהלקהלתופורת

תופורת;לנרדאהתטולבדוקפתתקידבלןתינה ACTH -ו)תויתיירטפתוקלדלןתינ( B ןיצירתופמא,םינתשמ,תוריצעלתופורתומכךמדב

;ןירופסולקיצןוגכלתשתייחדתעינמלתופורת;בצקתויעבבלופיטלתופורתומכבלבתויעבלתופורת;)היפרתומיכ(ןטרסבלופיטל

ןגלשאיחלמ,דירולימא,ןרטמאירט,ןוטקלונוריפסןוגכםדבןגלשאהתמרתאתולעהלתולוכיהתופורת;דימסורופןוגכתונתשמתופורת

;)םדבתירואההצמוחהתמרתתחפהלןתינ(לונירופולא;ןדיסיפסות;ןולוזינדרפואןוזינדרפןוגכתקלדבלופיטלםידיאורטס;ןירפהו

.)היספליפאל( ןיפזאמאבראק ;)םדב ןמושה תומכ תדרוהל( ןימאריטסלוכ ;)בלה בצקב תויעבב לופיטל ןתינ( דימאניאקורפ

:ןתוליעפ לע עיפשהל לוכי תואבה תופורתה םעפמוק סייטירטבוליש

תמררחאתונדפקבבוקעלשי,ךמדברכוסהתמרתאתיחפיפמוקסייטירטוןכתיי-ןילוסניאותוימופתופורתןוגכתרכוסלתופורת

םויתילהתמרתאלעהלםורגללוכיפמוקסייטירט-)תוישפנתויעבבלופיטלןתינה(םויתיל;פמוקסייטירטתליטנןמזבםדברכוסה

תופורת;הירלמלןיניק;םירירשהתייפרהלתופורת;פמוקסייטירטתליטנןמזבםויתילהתמררחאתונדפקבבוקעלאפורהלע,םדב

םדהלולידלתופורת;)םימוהיזל(ןיליצינפ;םילוח-תיבבןגטנרםוליצואהקירסת/רבועךניהםאןתניהלתולוכי,) iodine (ןידויתוליכמה

.ןיראפראוו ןוגכ הפה ךרד תונתינה

:יאוול תועפות

.הפורתה תא ת/לטונש ימ לכ לצא תועיפומ אל ולא תועפות ,יאוול תועפותל םורגל לוכיפמוק סייטירט,תופורתה לכב ומכ

י/קקדזתוןכתיי-תואבהתורומחהיאוולהתועפותמתחאבה/שחךניהםאדימאפורלי/הנפופמוקסייטירטבלופיטהי/קספה

תויהלםילוכיולא-החירפוץוצקעלםגוהמישנואהעילביישקלתמרוגהעולהואםייתפשה,םינפהתוחיפנ:ףוחדיאופרלופיטל

,תמייקתירועהלחמלשהרמחה,הפבםיביכ,החירפתללוכההפירחתירועהבוגת;פמוקסייטירטלהפירחתיגרלאהבוגתלםינמיס

Erythema multiforme וא Toxic epidermal necrolysis , Stevens-Johnson םורדניס ןוגכ( רועה לש תוקתנתה וא תויחופלש ,תוימומדא

,) palpitations (תורידסאלותוקזחבלתומיעפ,בלהבצקתרבגה:תואבהיאוולהתועפותמתחאבה/שחךניהםאדימאפורלי/חווד

ןובאיתבהתחפהוםימי2-3םיכשמנהםוחואלועיש,המישנרצוק;ץבשואבלףקתהומכרתויהרומחהיעבואהזחבץחל,הזחבבאכ

םומידלוהשלכןמיס,ליגרהמךוראןמזךשמלםומיד,תולקרתיבהלבחינמיסתעפוה;תואירבהיעבלםינמיסתויהלםילוכיולא-

,תופייעתשגרה,םוחוןורגבבאכ,ליגרהבצמהתמועלתולקבםימוהיזתעפוהוארועהלעםילוחכםינמיס,)םייכינחהמםומידאמגודל(

-בגלןירקהללוכישרומחןטבבאכ;םצעהחמבואםדבתויעבלםינמיסתויהלםילוכיולא-רוויחרועעבצואתרוחרחס,תופלעתה

םילוכי-)תבהצ(םייניעהוארועהתבהצה,הליחב,ןטבבאכ,ןובאיתדוביא,תופייע,תורומרמצ,םוח;בלבלבתקלדלןמיסתויהללוכי

.דבכב העיגפ וא דבכב תקלד ןוגכ דבכב תויעבל םינמיס תויהל

:תוללוכ תופסונ יאוול תועפות

.םימי רפסממ רתוי תכשמנ וא הרימחמ הטמ תוטרופמה תועפותהמ תחא םא ךלש אפורל י/עדוה אנא

ריבס-תרוחרחסתשוחת;השלוחואתופייעתשגרהואשארבאכ:)םישנא10ךותמ1-מתוחפבתועיפומ(תוחיכשתועפות

תוארמהםדתוקידב;סיטיכנורבואשבילועיש;פמוקסייטירטהלשןונימהתאלעהבואפמוקסייטירטבלופיטהתליחתםעעיפותש

ההובגהמרתוארמהםדתוקידב;ךתלחמתארימחהללוכיהזבצמתרכוסמת/לבוסךניהםא-םדברכוסלשליגרהמההובגהמר

.םיקרפמה לש תוחיפנו תוימומדא ,באכ ;םינמוש וא תירוא הצמוח לש ליגרהמ

ץחל,תופלעתה,המדאה;םיהבגומםירוזאילבואםערועבהחירפ:)םישנא100ךותמ1-מתוחפבתועיפומ(תוחיכשאלתועפות

ואתומדריה,ץוצקעןוגכהליגראלתירועתושיגרואדוריג;לקשמיווישבתויעב;תוריהמבםיבשייתמואםידמענשכדוחייבךומנםד

,םותסףא;החונמרסוחואליגרהמההובגתונבצע,הדרח,ןואכידתשגרה;הנישתויעב;םעטהשוחביונישואדוביא;לומינתשוחת

;םיינזואבםילוצלצ;תעמדואתוחיפנ,ץוצקע,תוימומדא-םייניעב;הפבתוחיפנ,םייכינחבתקלד;המישניישק,םיסוניסהלשתקלד

;ליגרהמתרבגומהנתשה;ילוחתשגרהואלוכיעיישק;ןטביבאכ,תוריצע;םירירשיבאכ;הזחבםיבאכ;רעישדוביא;הייארשוטשט

תויהלהלוכי-םיילגרותועורזתוחיפנ;בלהבצקביונישואהיילע;ןובאיתדוביאואהדירי;אמצתשגרהואליגרהמתרבגומהעזה

יאת,םימודאהםדהיאתרפסמבהדיריתוארמהםדתקידבתואצות;םירבגבתונואןיא;םוח;ליגרהמרתויףוגבםילזונתריצאלןמיס

תואצות;תוילכהואבלבלה,דבכהדוקפתביונישלעתודיעמהםדתוקידבתואצות;ןיבולגומההתומכבואםדהתויסטואםינבלהםדה

.ליגרהמ הכומנה ךמדב ןגלשא תמר לע תוארמה םד תקידב

ואןושלהתוחיפנואתוימומדא;תברצואלושלש,תואקה:)םישנא10,000ךותמ1-מתוחפבתועיפומ(רתויבתורידנתועפות

.ליגרהמ ההובגה ךמדב ןגלשא תמר לע תוארמה םד תקידב תואצות ;הפב שבוי

:וחוודש תופסונ יאוול תועפות

.םימי רפסממ רתוי תכשמנ וא הרומח תישענ הטמ תוטרופמה תועפותהמ תחא םא ךלש אפורל י/עדוה אנא

באכואץוצקעתשגרהןכמרחאלוךלרקרשאכםיילגרהוםיידיהתועבצאלשעבצביוניש;לובלבואהחונמרסוחתשגרה,זוכיריישק

;םיבוהצםיארנהםימצע;תימחלבשבוי;העימשבתוערפה;םדישירק;םירבגבהזחהתלדגה;) Raynaud ’ s phenomenon (םמחתמשכל

באכבתאטבתמה) intestinal angioedema (םייעמבתוחיפנ;)קורהתטולבלשתקלד(םייחלבתוימומדאואבאכ,תוחיפנ;תושבייתה

תורחאתוירועתויעבואםישוגתרוצבהחירפ,ץוצקע,רועהלשרומחףוליק;שמשהרואלתרבגומתושיגר;לושלשואהאקה,ןטב

רורחשאמגודל(םיינרופיצבתויעב;םייפגברוקתשגרהורועבםימתכ;רועבתולבחואתחרפת;חצמבואםינפבתימומדאהחירפומכ

הקושתבהדירי;םירירשהתוצווכתהואהשלוח;םיקרפמהתאזיזהלתלוכייאואםירירשןוישיק;)הסיסבמןרופיצהלשהדרפהוא

םדיאתבהיילע;ליגרהמההובגןתשברכוסתמר;תוילכבהיעבלןמיסתויהלהלוכי-ןתשבםדתעפוה;םישנבואםירבגבתינימה

םדתקידבתואצות;ךמדבםדהיאתטועימלעתוארמהםדתוקידבתואצות;םדתוקידבבהתפצנש-) eosinophilia (םימיוסמםינבל

יישק;םירבדלשתוחירביוניש;תובוגתביונישואהטאה;ךמדבדירולכוםויזנגמ,ןדיס,ןרתנ:ןוגכםיחלמהתומרביונישלעתוארמה

.המתסא לש הרמחה וא המישנ

:ןונימ

.תצלמומה הנמה לע רובעל ןיא .דבלב אפורה תוארוה יפל ןונימ

.18ליגל תחתמ םירגבתמו םידליל תדעוימ הניא וז הפורת

.לפטמה אפורה ידי-לע עבקנש יפכ םיעובק םינמזב וז הפורתב שמתשהל שי

!דחיב תונמ יתש לוטיל ןיא ןפוא םושב .אבה עובקה הליטנה ןמזב הנמלוטיל שי ,עובקה ןמזב וז הפורת לוטיל תחכש םא

:שומישה ןפוא

.החורא ירחא וא ןמזב ,ינפל הפורתה תא תחקל ןתינ .םימ םע הפורתה תא עולבל .קסרל ןיא !סועלל ןיא

.רקובב תחא הנמב הפורתה תא לוטיל ץלמומ

?לופיטה תחלצהל עייסל י/לכות דציכ

.אפורה ידי-לע ץלמוהש לופיטה תא םילשהל ךילע

.אפור םע תוצעייתה אלל הפורתב לופיטה קיספהל ןיא ךתואירב בצמב רופיש לח םא םג

י/ענמתךכידי-לעותוקוניתוא/וםידלילשםדיגשיהלץוחמרוגסםוקמברומשלשיתרחאהפורתלכווזהפורת!הלערהי/ענמ

רתיהתנמתאתלטנה/תאםא(םילוח-תיבלשןוימרדחלדימי/הנפ,הפורתהןמדליעלבתועטבםאוארתיתנמתלטנםא.הלערה

תשרופמהארוהאללהאקהלםורגלןיא.ךתיאהפורתהתזיראי/אבהו,)ךתואחקייוהשימשי/גאדאלאםילוחהתיבלךמצעבי/גהנתלא

.ךירכמ וא ךינכש ,ךיבורקל וז הפורת י/ןתית לא.קיזהל הלולע איה ת/רחא הלוחב ,ךתלחמב לופיטל המשרנ וז הפורת !אפורמ

.םהל ה/קוקז ךניה םא םייפקשמ ביכרהל שי .הפורת ת/לטונ ךניהשםעפ לכבהנמהו תיוותה קודבל שי !ךשוחבתופורת לוטיל ןיא

ךיראתל בל םישל אנ .דבלב תלבגומ הפוקתל תורמשנ תופורת ,םיצלמומההנסחאה/הזיראה יאנת יפל םג .25 0 C -ל תחתמ:הנסחא

.הזירא התואב תונוש תופורת ןסחאל ןיא .הפורתה תא ךל קפיסש חקורב ץעוויהל ךילע ,קפס לש הרקמ לכב !רישכתה לש הגופתה

.אפורל י/הנפ אנא ,המ רבדב ה/חוטב ךניא וא יהשלכ הלאש ךל שי םא .רישכתה לע עדימה לכ תא ללוכ אל הז ןולע

1222830188:ג"מ25/ג"מ5פמוק סייטירט 1222730187:ג"מ12.5/ג"מ2.5פמוק סייטירט:הפורתה םושיר 'סמ

.הילטיא ,סיטנווא-יפונאס:ןרצי

beasignofkidneyproblems;higherlevelofsugarintheurinethanusual;increaseincertainwhitebloodcells(eosinophilia)-that

wasobservedinbloodtests;bloodtestresultsshowingtoofewbloodcellsInyourblood;bloodtestresultsshowingachangeinthe

levelofsalts,e.g.:sodium,calcium,magnesiumandchlorideinyourblood;slowedorchangedreactions;changeinthewaythings

smell; difficulty breathing or worsening ofasthma.

Dosage:

Dosage is according to doctor's instructions only. Do not exceed the recommended dosage.

This medicine is not intended for administration to children and adolescents under the age of18.

Thismedicineistobetakenatspecifictimeintervalsasdeterminedbytheattendingdoctor.Ifyouforgettotakethismedicineatthe

specified time, take a dose at the next scheduled dosing time. Never take two doses together!

Directions for use:

Do not chew! Do not crush. Swallow the medicine with water. The medicine can be taken before, during or after a meal.

It is recommended that you take the medicine in one dose in the morning.

How can you contribute to the success ofthe treatment?

Complete the full course oftreatment as instructed by the doctor.

Even ifthere is an improvement in your health, do not discontinue use ofthis medicine without consulting your doctor.

Avoidpoisoning!Thismedicine,andallothermedicines,mustbestoredinasafeplaceoutofthereachofchildrenand/orinfants,

toavoidpoisoning.Ifyouhavetakenanoverdose,orifachildhasaccidentallyswallowedthemedicine,proceedimmediatelytoa

hospitalemergencyroom(ifyouhavetakenoverdose,donotdrivetothehospitalyourself,buthavesomeonetakeyou)andbring

the package ofthe medicine with you.

Donotinducevomitingunlessexplicitlyinstructedtodosobyadoctor!Thismedicinehasbeenprescribedforthetreatmentofyour

ailment; in another patient it may cause harm.Do not give this medicine to your relatives, neighbors or acquaintances.

Do not take medicines in the dark! Check the label and the doseeach timeyou take your medicine. Wear glasses ifyou need them.

Storage:Storebelow25°C.Evenifkeptintheiroriginalcontainerandstoredasrecommended,medicinesmaybekeptforalimited

periodonly.Pleasenotetheexpirydateofthemedicine!Incaseofdoubt,consultthepharmacistwhodispensedthemedicineto

you. Do not store different medications in the same package.

Thisleafletdoesnotcontainalltheinformationaboutyourmedicine.Ifyouhaveanyquestionsorarenotsureaboutanything,

ask your doctor.

License number:Tritace Comp 2.5 mg/12.5 mg:122 27 30187Tritace Comp 5 mg/25 mg:122 28 30188

Manufacturer:sanofi-aventis, Italy.

License holder:sanofi-aventis Israel Ltd., P.O. Box 8090, Netanya 42504.

TRIT COMP TAB PL SH 020910

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Enforcement Report for the Week of September 12, 2018

Enforcement Report for the Week of September 12, 2018

Recently Updated Records for the Week of September 12, 2018 Last Modified Date: Friday, September 07, 2018

FDA - U.S. Food and Drug Administration

29-8-2018

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

8-8-2018

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

19-7-2018

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

FDA - U.S. Food and Drug Administration

17-7-2018

The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens

The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens

Bells, TN – The Pictsweet Company has recalled 960 cases of Pictsweet Farms 12-ounce Steam’ables Baby Brussels Sprouts because they may contain undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy may run the risk of serious allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

30-5-2018

12 applications for allocation of special funds related to medicinal cannabis

12 applications for allocation of special funds related to medicinal cannabis

The application deadline for the second allocation of special funds for accumulation of scientific knowledge in regard to the medicinal cannabis pilot programme has now expired. The Danish Medicines Agency received 12 applications.

Danish Medicines Agency

19-4-2018

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

FDA - U.S. Food and Drug Administration

12-11-2018

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7555 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

5-9-2018

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application:  https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.usa.gov/xPcpn  #MedicalDevice

FDA - U.S. Food and Drug Administration

27-7-2018

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5043 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/158/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5032 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/998 (Orchard Therapeutics Ltd)

EU/3/12/998 (Orchard Therapeutics Ltd)

EU/3/12/998 (Active substance: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene) - Transfer of orphan designation - Commission Decision (2018)5062 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/014/12/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Active substance: tafamidis) - Transfer of orphan designation - Commission Decision (2018)5066 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/115/12/T/01

Europe -DG Health and Food Safety

22-7-2018

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device and earlier agency actions

FDA - U.S. Food and Drug Administration

19-7-2018

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Active substance: Humanised single chain monoclonal antibody against CD37) - Transfer of orphan designation - Commission Decision (2018)4839 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/128/12/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/12/999 (Merck Sharp and Dohme B.V.)

EU/3/12/999 (Merck Sharp and Dohme B.V.)

EU/3/12/999 (Active substance: Letermovir) - Transfer of orphan designation - Commission Decision (2018)4104 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/008/12/T/02

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

2-6-2018

EU/3/12/1046 (Novartis Europharm Limited)

EU/3/12/1046 (Novartis Europharm Limited)

EU/3/12/1046 (Active substance: Mavoglurant) - Transfer of orphan designation - Commission Decision (2018)3631 of Sat, 02 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/059/12/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1063 (Novartis Europharm Limited)

EU/3/12/1063 (Novartis Europharm Limited)

EU/3/12/1063 (Active substance: Panobinostat) - Transfer of orphan designation - Commission Decision (2018)3041 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/12/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Active substance: Humanised monoclonal antibody against P-selectin) - Transfer of orphan designation - Commission Decision (2018)3040 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/12/T/02

Europe -DG Health and Food Safety

6-4-2018

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Active substance: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotrophic factor) - Transfer of orphan designation - Commission Decision (2018)2008 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/11/T/01

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/12/1092 (Astellas Pharma Europe B.V.)

EU/3/12/1092 (Astellas Pharma Europe B.V.)

EU/3/12/1092 (Active substance: Chimeric monoclonal antibody against claudin 6) - Transfer of orphan designation - Commission Decision (2018)2009 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/147/12/T/01

Europe -DG Health and Food Safety

5-3-2018

EU/3/12/975 (Voisin Consulting S.A.R.L.)

EU/3/12/975 (Voisin Consulting S.A.R.L.)

EU/3/12/975 (Active substance: Carbetocin) - Transfer of orphan designation - Commission Decision (2018)1425 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/11/T/01

Europe -DG Health and Food Safety