كليكسان

المعلومات الرئيسية

  • اسم تجاري:
  • كليكسان
  • الشكل الصيدلاني:
  • SOLUTION FOR INJECTION
  • طريقة التعاطي:
  • I.V, S.C
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • SANOFI WINTHROP INDUSTRIE, FRANCE

المستندات

الأقلمة

  • متاح في:
  • كليكسان
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • ENOXAPARIN
  • الخصائص العلاجية:
  • Enoxaparin sodium is an anti-coagulant. At dosesof 20 mg and 40 mg it is indicated for: - Prophylactic treatment of thrombo-embolic disorders of venous origin and in particular in orthopedic surgery or in general surgery. - Prevention of thrombus formation in the extra-corporeal circulation during hemodialysis. At dosege of 40 mg the indications are: - Prophylactic treatment of deep vein thrombosis in patients who are bedridden due to an acute medial disorder: - Heart failure (HYHA class III or IV) - Acute respiratory failure - Episode of acute infection or acute rheumatic disorder combined with at least one other venous thromboembolic risk factor. At high doses of 60, 80 ,100 mg Clexan is indicated for: -Treatment of deep vein thrombosis (DVT). - Treatment of unstable angina and non-Q-wave myocardial infaction administered concurrently with aspirin. - Treatment of pulmonary embolism.Treatment of acute ST- segment elevation myocardial infarction, in combination with a thrombolytic agent in patients eligible o

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 46772603711
  • تاريخ الترخيص:
  • 01-02-2010
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة: نشرة المعلومات, خصائص المنتج

PATIENTPACKAGEINSERTINACCORDANCEWITHTHE

PHARMACISTS'REGULATIONS(PREPARATIONS)–1986

This medicine is dispensed

with a doctor's prescription only

CLExANE

20 mg, 40 mg, 60 mg, 80 mg, 100 mg

Injections

CLExANEFORTE

120 mg, 150 mg

Injections

Active ingredient and its quantity:

Eachpre-filledsyringewithasafetysystem

contains:

EnoxaparinSodium20mg,40mg,60mg,80mg,

100 mg, 120 mg, 150 mg

Inactive ingredients – see Section 6.

Readthispackageinsertcarefullyinits

entiretybeforeusingthismedicine.Keep

thisleaflet.Youmayneedtoreaditagain.This

leafletcontainsconciseinformationaboutthe

medicine.

Thismedicinehasbeenprescribedtotreatyou.

Donotpassitontoothers.Itmayharmthem

evenifitappearstoyouthattheirmedical

condition is similar.

Ifasideeffectworsensorifyounoticeanyside

effectnotlistedinthisleaflet,pleasereferto

the doctor or pharmacist.

Ifyouhavefurtherquestionsrefertothedoctor

or pharmacist.

1.FORWHATISTHEMEDICINE

INTENDED?

Thismedicineisusedtopreventandtreat

bloodclotformationandalsoforthetreatment

ofcertainkindsofanginaandmyocardial

infarction.

Therapeuticgroup:Ananti-coagulantfromthe

low molecular weight heparin group.

2.BEFORE USING THE MEDICINE:

Whenshouldthispreparationnotbe

used?

Donotusethismedicineifthereisaknown

sensitivitytoanyofitsingredients,heparinor

itsderivatives,includingotherlowmolecular

weight heparin preparations.

Donotuseinpatientswhohavesuffered

inthepastfromdecreasednumberof

plateletsduetotreatmentwithheparin

anditsderivatives,inpatientssuffering

frombleedingorpatientsathighriskof

uncontrolledhemorrhage,ifyouhavean

internalorexternallesionthatislikelyto

bleed, from hemorrhagic stroke.

Ifyousufferfromaninfectioninyourheart.

Specialwarningsregardinguseofthe

medicine:

Beforetreatmentwiththemedicinetellthe

doctor if:

yousufferfromhighbloodpressure,impaired

kidneyorliverfunction,ifyouhaveprosthetic

valves,ifyousufferfromdiabetesoraneye

diseasecalleddiabeticretinopathy(problems

withthebloodvesselsoftheeyesdueto

diabetes),fromproblemswiththebloodsystem

(suchascoagulation,etc.),fromoverweightor

underweight.

Ifyouaresufferingorhavesufferedinthepast

frombruisingorbleedingduetotreatment

with heparin preparations.

Ifyouhavehadastrokeinthepastorstomach

ulcer.

Ifyouhaverecentlyunderwentophthalmic/

head surgery.

even ifyou do not notice unusual effects.

Ifachildaccidentallyinjectedorswallowed

Clexane,proceedimmediatelytoahospital

emergency room.

Ifyou forgot to inject the medicine

IfyouforgottoselfinjectClexaneatthe

requiredtime,injectadoseassoonasyou

remember.

Donotinjectadoubledoseonthesame

daytocompensateforamisseddose.

Keepingadiarywillhelpyoubecertain

that you did not forget a dose.

Ifyou stop taking the medicine

Adheretothetreatmentrecommended

bythedoctor.Itisimportanttocontinue

theinjectionsuntilyourdoctorinstructs

youtostop.Ifyoustoptreatmentbefore

thetimerecommendedbythedoctor,you

maydevelopabloodclotthatcouldbevery

dangerous.

Tests and follow-up

Beforestartingtreatmentwiththismedicine

andsometimesduringtreatment,blood

testsshouldbeperformed.UseofClexane

mayinterferewiththeresultsofcertain

bloodtests.Itisimportanttoinformyour

doctorthatyouaretakingClexanebefore

blood tests are performed.

Donottakemedicinesinthedark!Check

thelabelandthedoseeachtimeyoutake

medicine.Wearglassesifyouneedthem.If

youhaveanyfurtherquestionsregarding

useofthemedicineconsultthedoctoror

pharmacist.

4.SIDE EFFECTS

Aswithanymedicine,useofClexanemay

causesideeffectsinsomeusers.Donotbe

alarmedwhenreadingthelistofsideeffects.

You may not suffer from any ofthem.

Refertothedoctororanemergencyroom

immediatelyifyouexperienceanyof

these effects:

Verycommon(occurringinmorethan1in

10 people):

Heavy bleeding from a wound.

Common(occurringin1-10in100people):

Painfulrashwithdarkredspotsunderthe

skinthatdonotdisappearwhenyoupress

onthem.Youmayalsoseepinkblotches

onyourskin.Theseblotchesusuallyoccur

in the area ofinjection.

Uncommon(occurringin1-10in1000

people):

Suddensevereheadache,maybeasignof

bleeding in the brain.

Afeelingofswelling,ordiscomfortinthe

stomach,maybeasignofbleedinginthe

stomach.

Rare(occurringinlessthan1in1000

people):

Allergicreaction.Thesignscaninclude:skin

rash,problemsbreathing,orswallowing,

swelling ofthe lips, face, throat or tongue.

Tinglingsensation,numbnessandmuscle

weakness,especiallyinthelowerpartof

yourbodyorlossofsphinctercontrol(you

areunabletocontrolyourbowels)afteryou

haveundergonespinalpunctureorspinal

anesthesia.

Consultyourdoctorassoonaspossible

ifyouexperienceanyofthefollowing

effects:

Common(occurringin1-10in100people):

Ifyouaretaking,orifyouhaverecently

taken,othermedicines,including

non-prescriptionmedicinesandnutritional

supplements,tellthedoctororpharmacist.

ThisisbecauseClexanecanaffecttheaction

ofothermedicinesandothermedicinescan

affect its action.

Especiallydonottakethismedicineand

informthedoctorifyouareusingamedicine

called heparin for treatment ofblood clots.

Tellyourdoctorifyouaretakingthe

following medicines:

warfarin - a medicine for thinning the blood

aspirin, abciximab, eptifibatide, iloprost,

ticlopidine,clopidogrel,tirofiban,orother

medicines that inhibit platelet aggregation

dextran injections - used as a blood replacer.

ibuprofen, diclofenac, ketorolac or other

medicinesusedtotreatpainandswelling

in arthritis and other diseases

antistreptase, streptokinase, urokinase -

preparations for dissolving blood clots

prednisolone, dexamethasone or other

medicines-fortreatmentofasthma,

rheumatoid arthritis and other conditions

sulfinpyrazone - for treatment of diabetes

valproic acid - for treatment of convulsions

diureticssuchas-spironolactone,triamterene,

amiloride,whichmayincreaseyourblood

potassium levels when taken with Clexane.

Yourdoctormaychangeoneofyourmedicines

ororderperiodicbloodteststoascertainthat

takingthesemedicineswithClexanedoesnot

cause you harm.

Surgery and anesthesia

Ifyouarescheduledtoundergospinal

punctureorsurgeryrequiringepiduralor

spinalanesthesiatellyourdoctorthatyou

areusingClexane.Alsotellyourdoctorifyou

havespinalproblemsorifyouhaveundergone

spinal surgery in the past.

Pregnancy and breastfeeding

Beforeusingthismedicinetellyourdoctor

ifyouarepregnant,couldbecomepregnant

orthinkyoumaybepregnant.Donotuse

thismedicineifyouarepregnantandhave

prostheticvalves,asyoumaybeatincreased

risk for developing blood clots.

Ifyouintendtobreastfeedyoushouldconsult

with the doctor.

3.HOW SHOULD YOU USE THE MEDICINE?

Alwaysuseaccordingtothedoctor’s

instructions.Consultwiththedoctoror

pharmacist ifyou are not sure.

Beforeuseofthemedicineyourdoctormay

refer you for blood tests.

Whileyouareinthehospitaladoctorornurse

willusuallygiveyouthemedicine,sinceitis

given by injection.

Whenyougethomeyoumayneedtocontinue

injectingClexaneyourself(seeInstructionsfor

Injection below).

Clexaneisusuallygivenbysubcutaneous

injection.

Dosage

Thedosageandtreatmentregimenwillbe

determinedbythedoctoronly.Thedosage

ofClexanedependsonthereasonyouare

using it.

Ifyousufferfromkidneyproblemsyoumay

need a lower dosage ofClexane.

Do not exceed the recommended dose.

Ifyouaccidentallyinjectedahigherdose

than required

Ifyouthinkthatyouusedtoomuchortoolittle

Clexane,consultwithyourdoctorimmediately,

RECOMMENDATIONSFORCOMFORTABLEAND

SAFEINJECTIONOFCLExANEANDCLExANE

FORTE, PRE-FILLED SYRINGES:

How to selfinject Clexane

IfyouareabletoselfinjectClexane,thedoctor

ornursewillshowyouhowtodoit.Donottry

toselfinjectifyouhavenotbeentrainedhow

todoso.Ifyouarenotsurewhattodorefer

to the doctor or nurse immediately.

Before selfinjecting Clexane

Checktheexpirydatemarkedonthe

medicine.Donotuseifthedatehaspassed.

Check that the syringe has not been

damagedandthatthemedicineinsideis

aclearsolution.Ifnot,useanotherClexane

syringe.

Make sure you know how much you have to

inject.

Check your stomach to see if the previous

injectioncausedanyredness,changeinskin

color,swelling,dischargethroughtheskin,

orifthereisstillasensationofpain.Ifso,

refer to the doctor or nurse.

Decide where you plan to inject the medicine.

Changetheplaceofinjectionfromtimeto

time,fromtherightsideofthestomachto

theleftsideofthestomach.InjectClexane

undertheskinofthestomachbutnottoo

closetothebellybuttonorscarredtissue(a

space ofat least 5 cm from these places).

Instructions for selfinjection ofClexane

1.Washyourhandsandtheintendedinjection

site with soap and water and dry them.

2.Sitorlieinacomfortablepositionandmake

sureyoucanseetheintendedinjectionarea.

3.Chooseaninjectionareaononesideofyour

stomach,atleast5cmawayfromyourbelly

button.

Remember:Donotselfinjectwithinaspace

oflessthan5cmfromthebellybutton,

scarredtissueorabruise.Changethearea

whereyouinjectbetweentheleftandright

sidesofyourstomach,dependingonwhere

you last injected.

4.Carefullyremovetheprotectivecapfromthe

needleanddiscardit.Thesyringeisready

perhapsasaresultofabloodclottingproblem

(thrombocytopenia).

Youexperiencepain,swellingorirritationin

theareaofinjection,usuallyimproveswithin

a few days.

Rare(occurringinlessthan1in1000

people):

Ifyouhaveamechanicalheartvalve,treatment

withClexanemaynotbesufficienttoprevent

formationofbloodclots.Youmayexperience

breathingdifficulties,tirednessordifficulty

performingphysicalactivity,chestpain,

numbness,feelingillorlossofconsciousness.

Thereasonforthismaybeabloodcloton

the valve.

Additionaleffectsforwhichyouneedto

consult the doctor, ifthey are bothersome:

Verycommon(occurringinmorethan1in

10 people):

Elevated liver enzymes in blood tests. Values

usuallyreturntonormalafteruseofClexane

is discontinued.

Rare(occurringinlessthan1in1000

people):

Change in blood potassium level. May occur in

peoplesufferingfromkidneyproblemsorfrom

diabetes.Yourdoctorcancheckthisbyhaving

a blood test performed.

Unknown frequency:

UseofClexaneforaprolongedperiodmay

increasetheriskofosteoporosis,acondition

in which the risk ofbone fractures increases.

Ifanyoftheseeffectsworsens,orpersists

formorethanafewdaysorifyouhaveside

effectsnotmentionedinthisleaflet,consult

with the doctor.

5.HOWSHOULDTHEMEDICINEBE

STORED?

Avoidpoisoning!Thismedicineandanyother

medicinemustbekeptinaclosedplaceoutof

thereachofchildrenand/orinfantstoavoid

poisoning.Donotinducevomitingunless

clearly indicated by the doctor.

Donotusethemedicineaftertheexpirydate

(exp.date)appearingonthepackage.Expiry

date refers to the last day ofthat month.

Donotstoreatatemperatureexceeding25°C.

Do not store in a refrigerator or freezer.

6.FURTHER INFORMATION

Inadditiontotheactiveingredient,the

medicine also containswater for injection.

Whatthemedicinelookslikeandcontents

ofthepack:Clexaneisaclearsolution,in

pre-filledsyringeswithaneedleandprotective

cap.

EachpackageofClexanecontains2syringes;

eachpackageofClexaneFortecontains10

syringes.

Thisleafletdoesnotcontainalltheinformation

aboutyourmedicine.Ifyouhaveanyquestions

orarenotsureaboutanything,pleaseaskyour

doctor.

Licenseholderandaddress:sanofi-aventis

Israel ltd., P.O.B. 8090, Natanya 42504.

Manufacturer:SanofiWinthropIndustrie,

France.

Thisleafletwascheckedandapprovedby

the Ministry ofHealth inOctober 2012.

DrugRegistrationNo.intheNationalDrug

Registry ofthe Ministry ofHealth:

Clexane: 467726037,

Donotpressontheplungerbeforethe

injectioninordertoexpelairbubbles.This

actioncancauselossofthemedicine.After

removingtheneedlecap,makesurethatthe

needledoesnottouchanythinginorderto

keep it clean (sterile).

5.Holdthesyringeinthehandyouwritewith

(likeapencil),andwithyourotherhand

gentlyholdaskinfoldbetweenyourthumb

andforefingerontheinjectionsiteonthe

stomach.

Makesureyouholdtheskinfold

throughout the entire injection.

6.Holdthesyringeverticallywiththeneedle

pointingdownwardsata90degreeangle

andinsertthefulllengthoftheneedleinto

the skin fold.

7.Injecttheentirecontentofthesyringeso

thatthemedicineentersthefatty

subcutaneous tissue of the stomach. Make

surethatyouareholdingtheskinfold

throughout the injection.

8.Removetheneedlebypullingitstraightout.

Theprotectivecapwillcovertheneedle

automatically.Youcannowletgooftheskin

fold.

Note:Thesafetysystem,whichenables

releaseofthesafetycap,willbeactivated

onlyafterthecontentofthesyringeis

emptiedbypressingtheplungerdown

completely.

Topreventbruises,donotrubthe

injection site after the injection.

9.Discardtheusedsyringewiththeprotective

capinacontainerforcollectionof

syringes,outofthereachofchildren.

,הקרזההרוזאביוריגואתוחיפנ,באכשחהתא

.םימי המכ ךות רפתשמ ללכ-ךרדב

1000ךותמ1-מתוחפבשחרתמ(רידנ

:)םישנא

ןסקלקבלופיט,ינכמבלםותסשךלשיםא

ישירקתורצוויהתעינמלקיפסהלאלשלולע

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,לומינ,הזחבבאכ,תינפוגתוליעפעצבלישוק

ךכלהביסה.הרכהןדבואואילוחתשגרה

.םותסשה לע םד שירק תויהל הלולע

ץעייתהלךירצהתאןהילעתופסונתועפות

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עוציבידילעתאזקודבללכויךלשאפורה

.םד תקידב

:העודי אל תוחיכש

לולעהכוראהפוקתךשמבןסקלקבשומיש

ובבצמ,סיזורופואטסואלןוכיסהתאריבגהל

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.אפורה םע ץעייתהל

?הפורתה תא ןסחאל ךיא.5

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םדיגשיהלץוחמרוגסםוקמברומשלשי

ענמתךכידילעותוקוניתוא/וםידלילש

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הגופתהךיראתירחאהפורתבשמתשהלןיא

ךיראת.הזיראהיבגלעעיפומה) exp . date (

ותואלשןורחאהםוילסחייתמהגופתה

.שדוח

ןיא,25 ºC לעהלועההרוטרפמטבןסחאלןיא

.איפקמב וא ררקמב ןסחאל

ףסונ עדימ.6

הליכמהפורתה,ליעפהרמוחהלעףסונ

.הקרזהל םימםג

:הזיראהןכותהמוהפורתהתיארנדציכ

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ןסקלק לש תימצע הקרזה תוארוה

דעוימההקרזההםוקמתאוםיידיהתאץחר.1

.םשבייו ןובסו םימב

האורךנהשאדווהחונהחונתבבכשואבש.2

.דעוימה הקרזהה רוזא תא

,ןטבהידיצמדחאבהקרזהרוזאברחב.3

הדיצהמ"ס5תוחפללשקחרמב

.רובטהמ

תוחפלשחוורמבךמצעלקירזתלא:רוכז

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.הנורחאל תקרזה ובש םוקמב

טחמהלעמןגמההסכמתאתוריהזברסה.4

לעהקרזההינפלהנכובהלעץחלתלא

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.)תוילירטס( הנויקינ לע רומשל תנמ

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תרזעב,ךנטבבהקרזההםוקמברוע

.הרומה עבצאהו לדוגאה

לכרועהלפקתאקיזחמךנהשאדו

.הקרזהה ךשמ

טחמהשכתיכנאהרוצבקרזמהתאקזחה.6

תולעמ90לשתיווזבהטמיפלכהנופ

לפקךותלטחמהךרואאולמתארדחהו

.רועה

הפורתהךכ,קרזמהתלוכתאולמתאקרזה.7

לשתירוע-תתהתינמושההמקרלסנכית

רועהלפקתאקיזחמךנהשאדו.ןטבה

.הקרזהה ךשמ לכ

רשיהתכישמידילעטחמהתאאצוה.8

טחמהתאהסכיןגמההסכמ.הצוחה

לפקתאררחשלןתינתעכ.יטמוטואןפואב

.רועה

רורחשרשפאמה,תוחיטבהןונגנמ:בלםיש

תונקורתהרחאלקרלעפוי,תוחיטבההסכמ

.האולמב הנכובה תציחל ידי לע קרזמה

םוקמתאףשפשלןיא,תורובחתעינמל

.הקרזהה רחאל הקרזהה

הסכמםעשמושמהקרזמהתאךלשה.9

גשיהמקחרה.םיקרזמףוסיאללכימלןגמה

.םידלי לש םדי

CLEX INJ PL SH 271112

םיחקורה תונקת יפל ןכרצל ןולע

1986- ו"משתה )םירישכת(

יפ לע תקוושמ הפורתה

דבלב אפור םשרמ

ןסקלק

,ג"מ80,ג"מ60,ג"מ40,ג"מ20

ג"מ100

תוקירז

הטרופ ןסקלק

ג"מ150,ג"מ120

תוקירז

:ותומכו ליעפ רמוח

ןונגנמםעשומישלןכומקרזמלכ

:ליכמ תוחיטב

EnoxaparinSodium20mg,40mg,60mg,

80 mg, 100 mg, 120 mg, 150 mg

.6ףיעס האר םיליעפ יתלב םירמוח

םרטבופוסדעןולעהתאןויעבארק

,הזןולעלערומש.הפורתבשמתשת

ליכמהזןולע.בושובאורקלךרטצתוןכתיי

.הפורתה לע יתיצמת עדימ

ריבעתלא.ךרובעלופיטלהמשרנוזהפורת

וליפאםהלקיזהלהלולעאיה.םירחאלהתוא

.המוד יאופרה םבצמ יכ ךל הארנ םא

העיפוהםאואהרימחמיאוולתעפותםא

אנא,הזןולעבתניוצמאלשיאוולתעפות

.חקורל וא אפורל הנפ

אפורהלאהנפ,תופסונתולאשךלשיםא

.חקורה לא וא

?הפורתה תדעוימ המל.1

תורצוויהבלופיטוהעינמלתשמשמהפורתה

לשםימיוסמםיגוסבלופיטלןכוםדישירק

.בלה רירשב םטואו הניגנא

תצובקמהשירקדגונ:תיטיופרתהצובק

.ךומנ ירלוקלומ לקשמ לעב ןירפה

:הפורתב שומיש ינפל.2

?רישכתב שמתשהל ןיא יתמ

דחאלתושיגר העודי םא שמתשהל ןיא

ויתורזגנואןירפה,הפורתהיביכרממ

לעבןירפהלשםירחאםירישכתללוכ

.ךומנ ירלוקלומ לקשמ

רבעבולבסשםילוחבשמתשהלןיא

לופיטתובקעבתויסטהרפסמבהדירימ

םילבוסהםילוחב,ויתורזגנוןירפהב

םומידלהובגןוכיסבםילוחואםומידמ

העיצפמלבוסךנהםא,רקובמיתלב

םומידלןוכיסםייקשתינוציחואתימינפ

.ימומיד עקר לע ץבשמ ,הנממ

.בלב תקלדמ לבוס התא םא

שומישלתועגונהתודחוימתורהזא

:הפורתב

:םא אפורל רפס הפורתב לופיטה ינפל

דוקפתביוקילמ,הובגםדץחלמלבוסךנה

םימתסמלעבךנהםא,דבכהואהילכה

תרכוסמלבוסךנהםא,םייתוכאלמ

diabetic תארקנהםייניעתלחממוא

םייניעבםדילכבתויעב( retinopathy

תכרעמבתויעבמ,)תרכוסמהאצותכ

ואלקשמףדועמ,)'וכוהשירקןוגכ(םדה

.לקשמ-תתמ

ואתולבחמרבעבתלבסואלבוסךנהםא

.ןירפה ירישכתב לופיט בקע םומיד

.הביק ביכמ וא ץבשמ רבעב תלבס םא

.שאר/םייניע חותינ הנורחאל תרבע םא

,הנורחאלתחקלםאוא,חקולהתאםא

םשרמאללתופורתללוכתורחאתופורת

.חקורלואאפורלךכלערפס,הנוזתיפסותו

תוליעפלעעיפשהללוכיןסקלקשינפמהז

תולוכיתורחאתופורתותורחאתופורתלש

.ותוליעפ לע עיפשהל

תאעדייווזההפורתהתאחקיתלאדחוימב

תארקנההפורתבשמתשמהתאםאאפורה

.םד ישירקב לופיטל ןירפה

תאחקולהתאםאךלשאפורלרפס

:תואבה תופורתה

םדלולידלהפורת-ןירפרוו

,דייטאביפיטפא,באמיסקיסבא,ןיריפסא

,לרגודיפולק,ןידיפולקיט,טסורפוליא

תובכעמהתורחאתופורתוא,ןאביפוריט

םד תויסט תתמצה

םדףילחתכתושמשמה-ןרטסקדתוקירז

תופורתואקלורוטק,קנפולקיד,ןפורפוביא

תוחיפנובאכבלופיטלתושמשמהתורחא

תורחא תולחמו םיקרפ תקלדב

-זאניקורוא,זאניקוטפרטס,זאטפרטסיטנא

םד ישירק קוריפל םירישכת

-תורחאתופורתואןוזטמסקד,ןולוסינדרפ

תיטמוארםיקרפתקלד,המטסאבלופיטל

םירחא םיבצמו

תרכוסבלופיטל-ןוזריפניפלוס

תותיוועבלופיטל-תיאורפלווהצמוח

,ןוטקלונוריפס-ומכםינתשמםירישכת

תולעהלםילולעה,דירולימא,ןרתמאירט

םעםיחקלנשכ,ךמדבןגלשאהתומרתא

.ןסקלק

תופורתהמתחאתאתונשליושעךלשאפורה

לעתויתפוקתםדתוקידבךלעצבלואךלש

ןסקלקםעוללהתופורתהתחיקלשאדוולתנמ

.קזנל ךל תמרוג הניא

המדרהו םיחותינ

הרדשהדומערוקינרובעלדמועךנהםא

ואתילארודיפאהמדרהךירצמהחותינוא

שומישלעךלשאפורלרפס,תילאניפס

ךלשיםאםגךלשאפורלרפס.ןסקלקב

רבעבתרבעםאואהרדשהדומעםעתויעב

.הרדשה דומעב חותינ

הקנהו ןוירה

םאוזהפורתבשומישינפלךלשאפורלירפס

תבשוחואןוירהלסנכיהלהיושע,ןוירהבךניה

םאוזהפורתבשמתשהלןיא.ןוירהבתאש

ןוויכ,םייתוכאלמםימתסמתלעבוןוירהבךניה

חותיפלרבגומןוכיסבתויהלהיושעתאש

.םד ישירק

.אפורהםעץעייתהלךיילעקינהלךתנווכבםא

?הפורתב שמתשת דציכ.3

ךילע.אפורתוארוהיפלשמתשהלשידימת

ךניאםאחקורהואאפורהםעץעייתהל

.חוטב

ךלשאפורהוןכתייהפורתבשומישהינפל

.םד תוקידב עוציבל ךתוא הנפי

תוחאואאפור,םילוחתיבבךנהשכ

איהשןוויכ,הפורתהתאךלונתיללכ-ךרדב

.הקרזהב תנתינ

ךישמהלךרטצתוןכתיהתיבהעיגתשכ

הקרזהתוארוההאר(ךמצעבןסקלקקירזהל

.)ךשמהב

.תירוע-תת הקרזהב ללכ-ךרדב ןתינ ןסקלק

ןונימ

אפורהידי-לעועבקיילופיטהןפואוןונימה

התאהבהביסביולתןסקלקהןונימ.דבלב

.ןסקלקב שמתשמ

ךרטצתוןכתיתוילכבתויעבמלבוסךנהםא

.ןסקלק לש רתוי ךומנ ןונימ

שרדנהמ הובג ןונימ תועטב תקרזה םא

ואידמרתויבתשמתשהשבשוחהתאםא

,ךלשאפורהםעדימץעייתה,ןסקלקידמתוחפ

.תוגירח תועפות הווח ךניא םא םג

הנפ,ןסקלקתועטבעלבואקירזהדליםא

.םילוח תיב לש ןוימ רדחל דימ

הפורתה תא קירזהל תחכש םא

,שורדהןמזבןסקלקךמצעלקירזהלתחכשםא

.תרכזנשכ דימ הנמ קירזהל שי

םויותואבהלופכהנמךמצעלקירזתלא

רוזעיןמוילוהינ.החכשנשהנמהלעיוציפכ

.הנמ חכוש ךניאש אדוול ךל

הפורתה תליטנ תא קיספמ התא םא

.אפורהידילעץלמוהשיפכלופיטבדימתהלשי

ךלשאפורהשדעתוקירזהתאךישמהלבושח

ינפללופיטהתאקיספתםא.קיספהלךלהרוי

חתפללולעהתאאפורהץילמהוילעןמזה

.ןכוסמ דאמ תויהל לולעש םד שירק

בקעמו תוקידב

םיתיעלו,וזהפורתבלופיטהתליחתינפל

שומיש.םדתוקידבךורעלשי,לופיטהךלהמב

תוקידבלשתואצותלעעיפשהליושעןסקלקב

ךלשאפורהתאעדייתשבושח.תומיוסמםד

.םד תוקידב עוציב ינפל ,ןסקלק תליטנ לע

הנמהותיוותהקודב!ךשוחבתופורתלוטילןיא

םייפקשמבכרה.הפורתלטונךנהשםעפלכב

תופסונתולאשךלשיםא.םהלקוקזךנהםא

ואאפורבץעוויה,הפורתבשומישלעגונב

.חקורב

יאוול תועפות.4

לולעןסקלקבשומישה,הפורתלכלומכ

.םישמתשמהמקלחביאוולתועפותלםורגל

.יאוולהתועפותתמישרארקמללהביתלא

.ןהמ תחא ףאמ לובסת אלו ןכתיי

םאדימןוימרדחלואאפורלתונפלשי

:וללה תועפותה תחאב שח התא

10ךותמ1-מרתויבשחרתמ(דאמחיכש

:)םישנא

.העיצפמ קזח םומיד

100ךותמ10דע1-בשחרתמ(חיכש

:)םישנא

תומודאתודוקנלשתבאוכהחירפתעפוה

התאשכתומלענןניארשא,רועלתחתמתוהכ

םימתכתוארלםגלוכיהתא.ןהילעץחול

ללכ-ךרדבוללהםימתכה.ךרועלעםידורו

.הקרזהה רוזאב םיעיפומ

1000ךותמ10דע1-בשחרתמ(חיכשאל

:)םישנא

לולע,ימואתפןפואבעיפומהרומחשארבאכ

.יחומ םומיד לש ןמיס תויהל

לולע,הביקבתוחוניאוא,תוחיפנתשגרה

.הביקב םומידל ןמיס תויהל

1000ךותמ1-מתוחפבשחרתמ(רידנ

:)םישנא

החירפ:לולכלםילוכיםינמיסה.תיגרלאהבוגת

תוחיפנ,העילבבואהמישנבתויעב,רועב

.ןושלב וא ןורגב ,םינפב ,םייתפשב

,םירירשתשלוחולומינ,ץוצקעתשוחת

הטילשדוביאואןותחתהךפוגגלפבדחוימב

תיישעלעטולשללגוסמךניא(םירגוסהלע

הרדשהדומעברוקינתרבעשרחאל)םיכרצה

.הרדשה דומעב המדרה וא

ירשפאהםדקהבךלשאפורהםעץעייתה

:תואבהתועפותהמתחאבשחהתאםא

100ךותמ10דע1-בשחרתמ(חיכש

:)םישנא

לוכי,ליגרהמתולקרתיבעצפנהתא

םדהתשירקבהיעבמהאצותכתויהל

.)הינפוטיצובמורט(

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

21-12-2018

Peer review of the pesticide risk assessment of the active substance propanil

Peer review of the pesticide risk assessment of the active substance propanil

Published on: Thu, 20 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of t...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Avian influenza overview August – November 2018

Avian influenza overview August – November 2018

Published on: Thu, 20 Dec 2018 Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Published on: Tue, 18 Dec 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

17-12-2018


Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

Europe - EMA - European Medicines Agency

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

Enforcement Report for the Week of November 21, 2018

Enforcement Report for the Week of November 21, 2018

Recently Updated Records for the Week of November 21, 2018 Last Modified Date: Tuesday, November 20, 2018

FDA - U.S. Food and Drug Administration

21-11-2018

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Published on: Tue, 20 Nov 2018 The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement wi...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Theme event on big data and medicine

Theme event on big data and medicine

The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

Danish Medicines Agency

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

20-12-2018

Namuscla (Lupin Europe GmbH)

Namuscla (Lupin Europe GmbH)

Namuscla (Active substance: Mexiletine) - New authorisation - Commission Decision (2018)9133 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4584

Europe -DG Health and Food Safety

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

12-12-2018


Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety