GEMKO 200 MG IV INF ICIN LIYOFILIZE

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  • GEMKO 200 MG IV INF. ICIN LIYOFILIZE TOZ ICEREN FLAKON
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  • 8699828790082
  • Yetkilendirme tarihi:
  • 29-01-2013
  • Son Güncelleme:
  • 24-05-2018

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KULLANMATALİMATI

GEMKO2000mgİ.V.infüzyoniçinliyofılizetoziçerenflakon

Damaryoluylauygulanır.

Steril,Apirojen

Etkinmadde:Gemsitabinhidroklorür2382.100mg(2000mggemsitabin’eeşdeğer)

Sodyumklorür450.000mg(%0.9)

Yardımcımaddeler:Mannitol,sodyumasetattrihidrat,sodyumhidroksit,konsantre

hidroklorikasitveenjeksiyonluksuiçerir.

Çözücüflakonda;enjeksiyonluksu.

BuilacıkullanmayabaşlamadanöncebuKULLANMATALİMATINI

dikkatliceokuyunuz,çünküsiziniçinönemlibilgileriçermektedir.

Bukullanmatalimatınısaklayınız.Dahasonratekrarokumayaihtiyaçduyabilirsiniz.

Eğerilavesorularınızolursa,lütfendoktorunuzaveyaeczacınızadanışınız.

Builaçkişiselolaraksiziniçinreçetelendirilmiştir,başkalarınavermeyiniz.

Builacınkullanımısırasında,doktoraveyahastaneyegittiğinizdebuilacı

kullandığınızıdoktorunuzasöyleyiniz.

Butalimattayazılanlaraaynenuyunuz.İlaçhakkındasizeönerilendozundışında

yüksekveyadüşükdozkullanmayınız.

BuKullanmaTalimatında:

1. GEMKOnedirveneiçinkullanılır?

2. GEMKO’yukullanmadanöncedikkatedilmesigerekenler

3. GEMKOnasılkullanılır?

4. Olasıyanetkilernelerdir?

5. GEMKO’nunsaklanması

Başlıklarıyeralmaktadır.

1.GEMKOnedirveneiçinkullanılır?

GEMKOambalajı,toziçerencambirflakonveçözücüiçerenbirampuldenoluşur.Toz

halindebulunanGEMKObeyazilakırıkbeyazarasırenktedir.Ampuliçindekiçözücüile

karıştırılarakhazırlanançözeltirenksiz,berraktır.

Hastaneeczacısı,hemşireveyadoktorGEMKO’yusterilsodyumklorürçözeltisindeçözüp

poşetveyapompadangeçirerektüpveiğneyardımıyladamarlarınızdanbirineverir.Buna

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intravenözinfüzyonadıverilir.

GEMKOsitotoksikbirilaçtır.Sitotoksikilaçlarkanserhücreleridedahilolmaküzerebütün

bölünenhücreleriöldürür.

GEMKO,mesanekanseri,akciğerkanseri(‘KüçükHücreliDışı’tipi),pankreaskanseri,

memekanseriveover(yumurtalık)kanserihastalarınıntedavisindekullanılır.

Eğerdoktorunuzsizebuilacıbaşkabirnedenleverdiyse,ilaçlailgilihertürlüsorunuzu

doktorunuzasorunuz.

2.GEMKO’yukullanmadanöncedikkatedilmesigerekenler

GEMKO’yuaşağıdakidurumlardaKULLANMAYINIZ

Eğer:

Gemsitabin’eyadaGEMKO’nuniçerdiğiyardımcımaddelerdenherhangibirinekarşı

aşırıduyarlı(alerjik)iseniz(yardımcımaddelerlistesinebakınız),

İleriderecedekaraciğerveyaböbrekprobleminizmevcutsa,

Hamileiseniz,

Emziriyorsanız.

GEMKO’yuaşağıdakidurumlardaDİKKATLİKULLANINIZ

Uzunsüreliveyaçoksayıda(haftadabirdenfazla)infüzyonuygulanmasıyan

etkileresebepolabilir.

GEMKOvediğersitotoksikilaçlarınçoğukemikiliğihücrelerinietkileyebilir.Bu

hücreleryenikanhücreleriüretmekiçinçokhızlıbölünürler.GEMKOtedavisi

sırasındasizdenkanörneklerialınacakveherfarklıtipkanhücrelerinin(trombositler

(pıhtılaşmayısağlayan),beyazkanhücrelerivekırmızıkanhücreleri)miktarlarıanaliz

edilecektir.Eğerkanhücrelerininmiktarıçokdüşüksedoktorunuzdozudeğiştirmeye

veyatedaviyikesmeyekararverebilir.Kemikiliğinizyenihücrelerürettikçekan

hücrelerininmiktarıçokgeçmedenartacaktır.

Herhangibirböbrekveyakaraciğerrahatsızlığı(hepatit,alkolizm,karaciğerkanseri)

yaşadıysanızveyayaşamaktaysanız.KaraciğerveböbreklerinizGEMKO’ınvücuttan

atılımınısağladığındanbuorganlarınızınnormalçalışıpçalışmadığınıkontroletmek

içintestyapılacaktır.Testsonuçlarınagöregerektiğindedoktorunuztedavinin

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kesilmesinekararverebilir.

GEMKOtedavisiyleilişkiliakciğerlerdebazenciddietkiler-raporedilmiştir.Bu

etkilerinnedenleribilinmemektedir.Akciğerödemi,akciğerhavakeselerinin

yaralanması,solunumyetmezliğinesebepolanciddiakciğeriltihabıgibietkiler

gözlenebilir.Eğerbugibietkileroluşursa,doktorunuztedavininkesilmesinekarar

verebilir.Erkendestekleyicibakım,durumundüzeltilmesindeyardımcıolacaktır.

GEMKOkullanmadanöncedoktorunuza,hemşirenizeveyahastaneeczacınızasöylemeniz

gerekenler;

Karaciğer,kalpvedamarhastalığınızvarsadahaöncebuhastalıklarıgeçirdiysenizya

daböbreklerinizleilgilibirprobleminizvarsalütfendoktorunuzaveyahastane

eczacınızasöyleyiniz,GEMKOkullanmamanızgerekebilir.Yakınzamanlarda

geçirilmişyadaalmayıplanladığınızradyoterapinizvarsalütfendoktorunuza

söyleyiniz,GEMKOilekullanımısonucuerkenveyageçradyasyonreaksiyonuolabilir.

Yakınzamandaaşıolmuşisenizlütfendoktorunuzasöyleyiniz,aşınınGEMKOile

yakınzamandauygulanmasıkötüetkilerenedenolabilir.

Builaçlatedavisırasındakonfüzyonlabirliktebaşağrısı,nöbetleryadagörmede

değişikliklergibisemptomlargörülürsederhaldoktorunuzuarayınız.Bu,çokseyrek

görülensinirsistemiyanetkisidir(posteriorgeridönüşümlüensefalopatisendromu).

Eğersolunumgüçlüğüyaşarsanızveyaçokgüçsüzhissedersenizveçoksolgunsanız,

lütfendoktorunuzasöyleyiniz,buböbrekyetmezliğininveyaakciğerlerinizleilgili

birsorununişaretiolabilir.

Vücutgenelindebirşişkinlik(ödem),nefesdarlığı(kısakısanefesalıpverme)veya

kiloalımıyaşarsanızlüftendoktorunuzasöyleyiniz,bukılcalkandamarlarınızdan

dokuyasızansıvınınişaretiolabilir.

ErkekhastalarınGEMKOiletedavisırasındavetedavisonrasında6ayakadarçocuksahibi

olmamalarıgerekir.Tedavinizsırasındaveyatedavibitiminitakipeden6ayiçindeçocuk

sahibiolmakisterseniz,doktorunuzaveyaeczacınızadanışınız.Tedavinizebaşlamadanönce,

spermsaklamahakkındadanışmanlıkalmakisteyebilirsiniz.

GEMKOiletedavisırasındakadınhastalarahamilekalmamaları,tedaviedendoktorun

uyarılmasıvetedavisonrasıgebekalınmasıtavsiyeedilmelidir.

Buuyarılargeçmiştekiherhangibirdönemdedahiolsasiziniçingeçerliyselütfendoktorunuza

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danışınız.

GEMKO’nunyiyecekveiçecekilekullanılması

Uygulamayöntemiaçısındanyiyecekveiçeceklerleetkileşimiyoktur.

Hamilelik

lacıkullanmadanöncedoktorunuzaveyaeczacınızadanışınız.

Gemsitabininhamilelikvebebeğinizüzerindezararlıetkileribulunmaktadır.

HamileysenizveyahamilekalmaolasılığınızvarsaGEMKO’yukullanmayınız.

Tedavinizsırasındahamileolduğunuzufarkedersenizhemendoktorunuzaveyaeczacınıza

danışınız.

Emzirme

lacıkullanmadanöncedoktorunuzaveyaeczacınızadanışınız.

GEMKO’nunannesütünegeçipgeçmediğibilinmemektedir.EmzirmedönemindeGEMKOile

tedavininmutlakgerekliolduğudurumlarda,tedavisüresinceemzirmebırakılmalıdır.

Araçvemakinekullanımı

GEMKOözelliklealkolaldıysanızuykuluhissettirebilir.GEMKOtedavisininuykulu

hissetmenizenedenolmadığındaneminolanakadarmotorluaraçvemakinelerikullanmayınız.

GEMKO’nuniçeriğindebulunanbazıyardımcımaddelerhakkındaönemlibilgiler

GEMKOiçeriğindekidiğeryardımcımaddelerekarşıaşırıbirduyarlılığınızyoksa,bu

maddelerebağlıolumsuzetkibeklenmez.

Sodyum;

Herbirflakon21.13mg(0.92mmol)sodyumiçerir;butıbbiürünherflakonda1mmol(23

mg)’dandahaazsodyumihtivaeder;yaniesasında‘‘sodyumiçermez’’.

Mannitol;

Uygulamayoluvedozunedeniyleuyarıgerektirmemektedir.

Diğerilaçlarilebirliktekullanımı

TümtümörtiplerindeGEMKO’nuntedaviedicidozlarındaradyasyonlabirliktegüvenli

uygulamasıiçinidealdozrejimihenüzbelirlenmemiştir.Yakınzamandaaşıolmuşiseniz

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lütfendoktorunuzasöyleyiniz,aşınınGEMKOileyakınzamandauygulanmasıkötüetkilere

nedenolabilir.

Eğerreçeteliyadareçetesizherhangibirilacışuandakullanıyorsanızveyasonzamanlarda

kullandınızsalütfendoktorunuzaveyaeczacınızabunlarhakkındabilgiveriniz.

3.GEMKOnasılkullanılır?

Uygunkullanımvedoz/uygulamasıklığıiçintalimatlar:

Normaldozvücutyüzeyalanınızınhermetrekaresibaşına800–1250miligramolacak

ekildehesaplanır.Doktorunuzveyahemşirenizgereklimiktarıuygunveniniziçine30-60

dakikasüresindeenjekteedecektir.

Enjeksiyonlarınızınuzunluğuveyasıklığıhastalığınızabağlıdır.Belirliaralıklarıtakipeden

haftalıkenjeksiyonlarla‘tedavikürleri’uygulanır.

Akciğerveyamesanekanseri:İkiveyaüçhaftaboyunca,haftadabirenjeksiyon

yapılacakve2haftasüreylearaverilereksonrakiküruygulanacaktır.GEMKO

tedavinizebaşkabirilaçolansisplatindeeklenebilir.

Pankreaskanseri:Yedihaftaboyunca,haftadabirkezenjeksiyonyapılacakve2hafta

süreylearaverilereksonrakiküruygulanacaktır.İkihaftanınardındanyinehaftadabir

kezolmaküzereüçhaftaboyuncaGEMKOenjeksiyonlarıyapılacaktır.

Memekanseri:İkihaftaboyunca,haftadabirenjeksiyonyapılacakve2haftasüreyle

araverilereksonrakiküruygulanacaktır.GEMKOiletedavinizdevamederken

tedavinizebaşkailaçlar(paklitaksel)daeklenebilir.

Overkanseri:İkihaftaboyunca,haftadabirenjeksiyonyapılacakve2haftasüreyleara

verilereksonrakiküruygulanacaktır.GEMKOiletedavinizdevamederkentedavinize

karboplatineklenebilir.

Aşağıdakişemaherbiri3’erenjeksiyonve1kesintidenoluşanarkaarkayaiki‘tedavi

kürü’neörnektir.

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Sizeiki‘tedavikürü’ndenfazlasıuygulanabilir.

Uygulamayoluvemetodu:

Hemşirenizboyunuzuvekilonuzuölçerekbuölçümlerdoğrultusundavücudunuzunyüzey

alanınıhesaplayacaktır.Doktorunuzvücudunuzunyüzeyalanıbüyüklüğünükullanaraksizin

içinuygunolandozakararverecektir.

TozhalindekiGEMKOileampuliçindekiçözücükarıştırılarakçözeltihazırlanır.Hazırlananbu

çözeltidahasonrabirtorbaveyapompadanbirtüpveiğneyoluyladamarlarınızdanbirine30

dakika–1saatliksüreyleverilir.Buuygulamaya‘intravenözinfüzyon’denir.Eğerklinik

dışındatedavigörüyorsanızbütünrandevularınızagitmenizönemlidir.

Değişikyaşgrupları:

Çocuklardakullanımı:

Etkililikvegüvenlilikileilgiliyeterliveriolmadığındanbuilacın18yaşaltıçocuklarda

kullanımıönerilmemektedir.

Yaşlılardakullanımı:

Yaşlılardadozdeğişikliğiyapılmasıgerektiğinedairbirkanıtbulunmamaktadır.

Özelkullanımdurumları:

Böbrek/karaciğeryetmezliği

Hafifderecedekaraciğeryetmezliğivehafifilaortaderecedeböbrekyetmezliğidurumunda

doktorunuztedaviniziyakındantakipedecek,gerektiğindetedavinizinkesilmesiniisteyecektir.

Doktorunuzayrıbirtavsiyedebulunmadıkça,butalimatlarıtakipediniz.

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lacınızızamanındaalmayıunutmayınız.

DoktorunuzGEMKOiletedavinizinnekadarsüreceğinisizebildirecektir.Tedaviyierken

kesmeyinizçünküistenensonucualamazsınız.

EğerGEMKO’nunetkisininçokgüçlüveyazayıfolduğunadairbirizleniminizvarise

doktorunuzveyaeczacınızilekonuşunuz.

KullanmanızgerekendenfazlaGEMKOkullandıysanız:

GEMKO’dankullanmanızgerekendenfazlasınıkullanmışsanızbirdoktorveyaeczacıile

konuşunuz.

GEMKOdoktorveyahemşiretarafındanuygulanacağından,ilacınfazlamiktardaverilmesipek

muhtemeldeğildir.Ancaksizeuygulananilacınçokfazlaolduğunudüşünüyorsanız,hemen

doktorveyahemşireyesöyleyiniz.

GEMKO’yukullanmayıunutursanız:

Doktorunuzatlanandozunnezamanuygulanacağınakararverecektir.

Takipedendozunyeniuygulamazamanıiçindoktorunuzuntalimatlarınauymanızönemlidir.

Unutulandozlarıdengelemekiçinçiftdozalmayınız.

GEMKOiletedavisonlandırıldığındaoluşabileceketkiler:

GEMKOtedavisinisonlandırmakhastalığınızındahakötüyegitmesinenedenolabilir.

DoktorunuztarafındanbelirtilmedikçeGEMKOkullanmayıbırakmayınız.GEMKO’nun

kullanımıileilgiliherhangibirsorunuzvarsadoktorunuzveyaeczacınızadanışınız.

4.Olasıyanetkilernelerdir?

Tümilaçlargibi,GEMKO’ıniçeriğindebulunanmaddelereduyarlıolankişilerdeyanetkiler

olabilir.

Aşağıdakilerdenbiriolursa,GEMKO’yukullanmayıdurdurunuzveDERHAL

doktorunuzabildirinizveyasizeenyakınhastaneninacilbölümünebaşvurunuz:

Durdurulamayankanamanızvarsa(dişeti,burunveyaağızdaveyaherhangibir

bölgedekanama),kırmızımsıveyapembemsirenkteidraraçıkma,sebepsizmorarma

olursa(kandakitrombosit(pıhtıhücresi)sayısınınnormaldendahaazolabilmesinebağlı

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olarak),

Yorgunluk,halsizlikvarsaveyakolaycanefesinizdaralıyorsaveyasolgun

görünüyorsanız(kırmızıkanhücrelerininsayısınınnormaldendahaazolmasınabağlı

olarak)(çokyaygın),

Hafifveortaşiddettederidöküntüsü,kaşıntıyadaateşvarsa(alerjikreaksiyonlar)

(çokyaygın),

38 oCveyadahayüksekateş,terlemeveyadiğerenfeksiyonbelirtilerivarsa(febril

nötropeniolarakdabilinenateşilebirliktebeyazkanhücrelerininsayısının

normaldendahaazolmasınabağlıolarak)(yaygın),

Ağzınızdaağrı,kızarıklık,şişmeveyayaravarsa(yaygın),

Düzensizkalpatışı(aritmi)varsa(yaygınolmayan),

Aşırıyorgunlukvezayıflık,purpurayadaderidekanayanküçükalanlar(morluklar),

akutböbrekyetmezliği(düşükidrarçıkışı/yadaidrarçıkışınınolmaması)ve

enfeksiyonbelirtileri(hemalotiküremiksendromu)varsa.Ölümesebepolabilir.(yaygın

olmayan),

Solunumproblemlerinizvarsa(İnfüzyondanhemensonrayaygınolarakgörülen

hafifsolunumproblemlerikısazamandageçer,bununlabirlikteyaygınolmayanveya

seyrekolarakdahaciddiakciğerproblemlerigörülebilir),

Ciddigöğüsağrısı(miyokartenfarktüsü)varsa(seyrek),

Kırmızırenklikaşıntılıcildiiçerenciddideridöküntüsü,eller,ayaklar,bilekler,

yüz,dudakyadaağızveboğazınşiştiği(yutmayıvenefesalmayızorlaştıracakşekilde)

ciddihipersensitivite/alerjikreaksiyon,hırıltı,hızlıkalpatışıveyabaygınlıkhissivarsa

(anafilaktikreaksiyon)(çokseyrek),

Küçükkandamarlarınızdandokuyasıvısızıntınızolabileceğinden,genelleşmişbir

işkinlik,nefesdarlığıveyakiloalımı(kapillerkaçışsendromu)(çokseyrek)

Görmebozukluğuylabirliktebaşağrısı,konfüzyon,nöbetler(posteriorgeri

dönüşümlüensefalopatisendromu)varsa(çokseyrek),

Deridekaşıntıilebirlikteciddidöküntü,kabarmavesoyulma(StevensJohnson

sendromuveyatoksikepidermalnekroliz)varsa(çokseyrek).

Bunlarınhepsiçokciddiyanetkilerdir.Eğerbunlardanbirisizdemevcutise,sizinGEMKO’ya

karşıciddialerjinizvardemektir.Aciltıbbimüdahaleyeveyahastaneyeyatırılmanızagerek

olabilir.

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GEMKOilegörülendiğeryanetkileraşağıdakileriiçerebilir:

Çokyaygın:(10hastanın1’indenfazlasınıetkiler)

Akyuvarsayısınınazolması,

Nefesalmadagüçlük,

Kusma,

Bulantı,

Saçdökülmesi,

Karaciğerproblemleri:anormalkantestisonuçlarındabulunmuştur,

drardakan,

Anormalidrartestleri:idrardaprotein,

Ateşdahilsoğukalgınlığıbenzerisemptomlar,

Bilekler,elparmakları,ayaklar,yüzünşişmesi(ödem)

Yaygın:(100hastanın1ila10’unuetkiler)

İş tahsızlık(anoreksi),

Baş ağrısı,

Uykusuzluk,

Uyuklama,

Öksürük,

Burunakıntısı,

Kabızlık,

shal,

Kaşıntı,

Terleme,

Kasağrısı,

Sırtağrısı,

Ateş,

Güçsüzlük,

Üşüme,

Bilirubinartışı.

Yaygınolmayan:(1,000hastanın1ila10’unuetkiler)

Akciğerhavakeselerininyaralanması(interstisyelpnömoni),

Hırıltılısolunum(havayollarınınspazmı),

Akciğerlerinyaralanması(anormalakciğergrafisi/taraması),

10

Kalp yetmezliği,

Böbrekyetmezliği,

Karaciğeryetmezliğidahilciddikaraciğerhasarı,

nme.

Seyrek:(10,000hastanın1ila10’unuetkiler)

Düşükkanbasıncı,

Deridesoyulma,ülserveyakabarcıkoluşumu,

Deridepullanmaveciddikabartı,

Enjeksiyonunyapıldığıbölgedereaksiyonlar,

Solunumyetmezliğinesebepolanciddiakciğeriltihabı(YetişkinSolunumSıkıntısıSendromu),

Dahaönceradyoterapiuygulanmışciltteortayaçıkabilecekciddigüneşyanığınabenzeyen

döküntü(radyasyonçağrışımı),

Akciğerlerdesıvı,

Radyasyonterapisiileilişkiliakciğerhavakeselerininyaralanması(radyasyontoksisitesi),

Elveayakparmaklarındagangren,

Kandamarlarındailtihaplanma(periferalvaskülit),

BirenzimolanGamaGlutamilTransferazda(GGT)artış.

Çokseyrek:(10,000hastanın1’indendahaazınıetkiler)

Artmışkanpulcuğu(platelet)sayısı,

Kanakışınınazalmasınınnedenolduğukalınbağırsakduvarındailtihap(iskemikkolit).

Düşükhemoglobinseviyesi(anemi),beyazkanhücrelerininsayısınınnormaldendahaaz

olmasıvedüşükkanpulcuğusayısıkantestiilebelirlenebilir.

Bubelirtive/veyadurumlardanherhangibirisisizdeolabilir.Buyanetkilerdenherhangibiri

başınızagelmişseenkısazamandadoktorunuzabildiriniz.

Eğerbuyanetkilerdenherhangibirihakkındaendişenizvarsalütfendoktorunuzlakonuşun.

Eğerbukullanmatalimatındabahsigeçmeyenherhangibiryanetkiilekarşılaşırsanız

doktorunuzuveyaeczacınızıbilgilendiriniz.

11

Yanetkilerinraporlanması

KullanmaTalimatındayeralanveyaalmayanherhangibiryanetkimeydanagelmesi

durumundahekiminiz,eczacınızveyahemşirenizilekonuşunuz.Ayrıcakarşılaştığınızyan

etkileriwww.titck.gov.trsitesindeyeralan“İlaçYanEtkiBildirimi”ikonunatıklayarakyada

08003140008numaralıyanetkibildirimhattınıarayarakTürkiyeFarmakovijilansMerkezi

(TÜFAM)’nebildiriniz.Meydanagelenyanetkileribildirerekkullanmaktaolduğunuzilacın

güvenliliğihakkındadahafazlabilgiedinilmesinekatkısağlamışolacaksınız.

5. GEMKO’nunsaklanması

GEMKO’yuçocuklarıngöremeyeceği,erişemeyeceğiyerlerdeveambalajındasaklayınız.

Flakonları25 o C’ninaltındakiodasıcaklığında,kurubiryerdeveışıktankoruyaraksaklayınız.

Sterilsodyumklorürçözeltisi(%0.9’luk)ilehazırlanançözelti 25 o

C’ninaltındakioda

sıcaklığındasaklanmalıdır.

Hazırlanançözeltihemenkullanılmalıdır,hemenkullanılmayacaksa25 o C’ninaltındakioda

sıcaklığındaenfazla24saatsaklanabilir.Hazırlanançözeltidondurulmamalıdır.

Sonkullanmatarihiyleuyumluolarakkullanınız.

AmbalajdakisonkullanmatarihindensonraGEMKO’yukullanmayınız.

Eğerüründeve/veyaambalajındabozuklukfarkedersenizGEMKO’yukullanmayınız.

Ruhsatsahibi:KOÇAKFARMAİLAÇVEKİMYASANAYİA.Ş.

MahmutbeyMah.KuğuSok.No:18

Bağcılar/İSTANBUL

Üretimyeri:KOÇAKFARMAİLAÇVEKİMYASANAYİA.Ş.

ÇerkezköyOrganizeSanayiBölgesi

Kapaklı/Tekirdağ

Bukullanmatalimatı(02/12/2015)tarihindeonaylanmıştır.

12

LACIUYGULAYACAKSAĞLIKPERSONELİİÇİNBİLGİLER

Uygulamaşekli

Gemsitabininfüzyonsırasındaiyitolereedilmekteolup,ayaktanuygulanabilir.Eğer

ekstravazasyonortayaçıkacakolursa,genelolarakinfüzyonderhaldurdurulmalıvebaşkabir

damardantekrarbaşlatılmalıdır.Uygulamasonrasındahastadikkatleizlenmelidir.

Sulandırmatalimatı(veilaveseyreltmeler,eğergerçekleştirilmişse)

Gemsitabininsadecekullanımahazırlanmasıamacıylaonaylanantekseyreltici,herhangibir

koruyucuiçermeyen%0.9’luksodyumklorürçözeltisidir(50ml).Çözünürlükgörüşlerine

göre,kullanımiçinhazırlanangemsitabininmaksimumkonsantrasyonu40mg/ml’dir.

40mg/ml’denbüyüksulandırılankonsantrasyonlartamamlanmamışdissolüsyonayol

açabileceğinden,sakınılmalıdır.

1.Sulandırmasırasındavegemsitabininintravenözuygulamasıiçinileriseyreltmeleriaseptik

teknikkullanılarakyapınız.

2.Sulandırmakiçin2g’lıkflakonakoruyucusuz9mg/ml’lik(%0.9)50mlenjeksiyonluksteril

sodyumklorürçözeltisindenilaveedilir.Sulandırdıktansonratoplamhacim52.6ml’dir.Bu40

mg/ml’likgemsitabinkonsantrasyonunakarşıgelirkiliyofılizetozunyerinekoyulanhacme

tekabüleder.Çözünmesiiçinçalkalayınız.Koruyucusuz9mg/ml’lik(%0.9)50ml

enjeksiyonluksterilsodyumklorürçözeltisiileilaveseyreltmelerdeyapılabilir.Sulandırılan

çözeltirenksiz,berraktır.

3.Parenteraltıbbiürünleruygulamadanöncerenkdeğişikliğivepartikülmaddeaçısından

gözlekontroledilmelidir.Eğerpartikülmaddegözlenirse,uygulanmamalıdır.

Kullanılmamışürünleryadaatıkmateryaller’TıbbiÜrünlerinKontrolüYönetmeliği’ve

‘AmbalajAtıklarınınKontrolüYönetmeliği’neuygunolarakimhaedilmelidir.

Hazırlamaveuygulamaönlemleri:

nfüzyonçözeltisininhazırlanmasıvekullanımındasitotoksikajanlariçinalınantipikgüvenlik

önlemlerineuyulmalıdır.İnfüzyonçözeltisihazırlanmasıemniyetkabinindekoruyucukıyafet

veeldivenkullanılarakyapılmalıdır.Eğeremniyetkabiniuygundeğilseekipmanmaskeve

koruyucugözlükiletamamlanmalıdır.Eğerpreparatgöziletemasedersebuciddiiritasyona

sebepolabilir.Gözhemensuylaiyiceyıkanmalıdır.Eğerkalıcıtahrişvarsabirdoktora

danışılmalıdır.Çözelticildedökülürsesuylaiyiceyıkanmalıdır.

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

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 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, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene 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 the representative uses of (EZ)‐1,3‐dichloropropene ...

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

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

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M 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 the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

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

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

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

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

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) 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...

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

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin 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 the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

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

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 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

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 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 fenbuconazole. To assess the occurrence of fenbuconazole 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...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

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

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

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

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

FDA - U.S. Food and Drug Administration

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

7-9-2018

Newsletter:  Human medicines highlights - September 2018

Newsletter: Human medicines highlights - September 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

3-9-2018

Webinar: TGA fast track approval of prescription medicines: Information for health professionals

Webinar: TGA fast track approval of prescription medicines: Information for health professionals

To provide health professionals with information on how new pathways will contribute to providing treatment for patients with serious and life threatening conditions

Therapeutic Goods Administration - Australia

15-8-2018

Scientific guideline:  Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005

Europe - EMA - European Medicines Agency

6-8-2018

Human medicines highlights - August 2018

Human medicines highlights - August 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

30-7-2018

Compliance and education for listed medicines

Compliance and education for listed medicines

Updated information

Therapeutic Goods Administration - Australia

27-7-2018

Scientific guideline:  Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

Scientific guideline: Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

The guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.

Europe - EMA - European Medicines Agency

10-7-2018

Human medicines highlights - July 2018

Human medicines highlights - July 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

5-7-2018

Scientific guideline:  Draft guideline on the use of adjuvanted veterinary vaccines, draft: consultation open

Scientific guideline: Draft guideline on the use of adjuvanted veterinary vaccines, draft: consultation open

The main aim of the guideline is to outline the information which should be included for the adjuvant in the marketing authorisation application (MAA) of an immunological veterinary medicinal product (IVMP). This guideline replaces the ‘Note for Guidance on the use of adjuvanted veterinary vaccines’. The guideline discusses the important aspects to consider for the adjuvant in an IVMP and provides guidance on the information on the adjuvant which should be included in Parts 2, 3 and 4 of the MAA. The d...

Europe - EMA - European Medicines Agency

27-6-2018

Regulatory and procedural guideline:  Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product

Regulatory and procedural guideline: Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product

This document outlines the general principles to follow for the preparation of the summary of product characteristics (SmPC) for a generic, hybrid or biosimilar medicinal product to be authorised via the centralised procedure using a reference medicinal product authorised either at national level or centrally.

Europe - EMA - European Medicines Agency

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency

29-5-2018

Medicinal cannabis products: Patient information

Medicinal cannabis products: Patient information

Medicinal cannabis: Patient information

Therapeutic Goods Administration - Australia

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

10-5-2018

Inhalation and nasal spray registered medicines

Inhalation and nasal spray registered medicines

New information about application pathways and data requirements for inhalation and nasal spray registered medicines

Therapeutic Goods Administration - Australia

8-5-2018

Human medicines highlights - June 2018

Human medicines highlights - June 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

9-4-2018

Human medicines highlights - April 2018

Human medicines highlights - April 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

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

28-3-2018

EU/3/04/241 (Roche Registration GmbH)

EU/3/04/241 (Roche Registration GmbH)

EU/3/04/241 (Active substance: Pirfenidone) - Transfer of orphan designation - Commission Decision (2018)2006 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/052/04/T/03

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

28-3-2018

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Active substance: Chimeric monoclonal antibody against claudin-18 splice variant 2) - Transfer of orphan designation - Commission Decision (2018)2007 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/083/10/T/01

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety