Ampril 10 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Ampril 10 mg tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: svaka tableta sadrži 10 mg ramiprila
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka d.d., Novo mesto, Slovenija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Ampril 10 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-322523785-01]; 60 tableta u blisteru, u kutiji [HR-H-322523785-02] Urbroj: 381-12-01/30-18-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-322523785
  • Datum autorizacije:
  • 31-01-2018
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku: sastav, indikacije, doziranje, nuspojave, interakcija, trudnoća, dojenje

Uputa o lijeku: Informacije za bolesnika

Ampril 1,25 mg tablete

Ampril 2,5 mg tablete

Ampril 5 mg tablete

Ampril 10 mg tablete

ramipril

Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne

podatke.

Sačuvajte ovu uputu. Moţda ćete je trebati ponovo pročitati.

Ako imate dodatnih pitanja, obratite se Vašem liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Moţe im naškoditi, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti Vašeg liječnika ili ljekarnika. To

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Ampril i za što se koristi?

Što morate znati prije nego počnete uzimati Ampril?

Kako uzimati Ampril?

Moguće nuspojave

Kako čuvati Ampril?

Sadrţaj pakiranja i druge informacije

1.

Što je Ampril i za što se koristi?

Ampril sadrţi djelatnu tvar ramipril i pripada skupini lijekova koja se naziva ACE inhibitori (inhibitori

angiotenzin konvertirajućeg enzima).

Ampril djeluje tako što:

smanjuje proizvodnju tvari u Vašem tijelu koje bi mogle povisiti krvni tlak,

opušta i širi Vaše krvne ţile,

olakšava srcu da pumpa krv po Vašem tijelu.

Ampril se moţe koristiti za:

liječenje visokog krvnog tlaka (hipertenzija),

smanjenje rizika od srčanog ili moţdanog udara,

smanjenje rizika ili odgaĎanje pogoršanja poteškoća s bubrezima (bez obzira imate li šećernu

bolest ili ne),

liječenje srca koje ne moţe osigurati dovoljno krvi ostatku tijela (zatajenje srca),

liječenje nakon srčanog udara (infarkt miokarda), sa srčanim zatajenjem.

2.

Što morate znati prije nego počnete uzimati Ampril?

Nemojte uzimati Ampril

ako ste alergični na ramipril, bilo koji drugi ACE inhibitor ili neki drugi sastojak ovog lijeka

(naveden u dijelu 6.).

Znakovi alergijske reakcije mogu uključivati osip, poteškoće s gutanjem ili disanjem, oticanje

usana, lica, grla ili jezika.

ako ste ikad imali ozbiljnu alergijsku reakciju zvanu angioedem. Znakovi ove reakcije uključuju

svrbeţ, koprivnjaču (urtikarija), crvene mrlje po rukama, stopalima i vratu, oticanje grla i jezika,

oticanje oko očiju i usana, teškoće pri disanju i gutanju.

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ako ste na dijalizi ili nekom drugom obliku filtracije krvi. Ovisno o aparatu koji se koristi

Ampril moţda nije pogodan za Vas;

ako imate poteškoća s bubrezima, pri čemu je smanjena opskrba bubrega krvlju (stenoza

bubreţne arterije).

tijekom zadnjih 6 mjeseci trudnoće (vidjeti dio ispod „Trudnoća i dojenje“).

ako je Vaš krvni tlak abnormalno nizak ili nestabilan (Vaš liječnik treba donijeti tu procjenu).

ako imate šećernu bolest ili oštećenu bubreţnu funkciju i liječite se lijekom za sniţavanje

krvnog tlaka koji sadrţi aliskiren.

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Ampril:

ako imate poteškoća sa srcem, jetrom ili bubrezima,

ako ste izgubili puno soli ili tekućine iz tijela (zbog bolesti - povraćanja, proljeva, neuobičajeno

pojačanog znojenja, prehrane s malim unosom soli, dugotrajnog uzimanja diuretika ili zbog

dijalize),

ako imate predviĎenu terapiju za smanjenje alergije na ubod pčela ili osa (desenzitizacija),

ako trebate primiti anestetik. To se odnosi na operaciju ili zahvat na zubima, pri čemu ćete

moţda trebati prekinuti liječenje Amprilom jedan dan prije; upitajte liječnika za savjet,

ako imate visoku koncentraciju kalija u krvi (vidljivu u rezultatima krvnih pretraga),

ako uzimate bilo koji od sljedećih lijekova jer oni mogu povećati rizik od nastanka angioedema

(brzo oticanje potkoţnog tkiva u području poput grla):

sirolimus, everolimus i ostali lijekovi koji pripadaju skupini mTOR inhibitora (koriste se

kako bi se izbjeglo odbacivanje presaĎenih organa),

DPP-IV inhibitori (vildagliptin, saksagliptin ili linagliptin),

racekadotril.

ako imate vaskularnu bolest vezivnog tkiva, kao sto je skleroderma ili sistemski lupus

erythematosus,

ako mislite da ste trudni ili da biste mogli zatrudnjeti morate obavijestiti Vašeg liječnika;

Ampril se ne preporučuje u prva 3 mjeseca trudnoće i ne smije se uzimati ako ste više od tri

mjeseca trudni, jer moţe ozbiljno naštetiti Vašem djetetu ako se uzima u tom stadiju (pogledajte

dio Trudnoća i dojenje).

ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog

krvnog tlaka:

blokator angiotenzin II receptora (ARB) (nazivaju se i sartanima – primjerice valsartan,

telmisartan, irbesartan), osobito ako imate bubreţne tegobe povezane sa šećernom

bolešću.

aliskiren.

Liječnik Vam moţe provjeravati bubreţnu funkciju, krvni tlak i količinu elektrolita (npr. kalija) u krvi

u redovitim intervalima.

Pogledajte takoĎer informacije pod naslovom „Nemojte uzimati Ampril“.

Djeca i adolescenti

Ampril se ne preporučuje za primjenu u djece i adolescenata mlaĎih od 18 godina budući da sigurnost

i učinkovitost primjene ramiprila u djece još nije utvrĎena.

Ako se bilo što od navedenog odnosi na Vas (ili niste sigurni), posavjetujte se s Vašim liječnikom prije

uzimanja Amprila.

Drugi lijekovi i Ampril

Obavijestite Vašeg liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje

druge lijekove. Naime, Ampril moţe utjecati na učinak drugih lijekova te takoĎer drugi lijekovi mogu

utjecati na učinak Amprila.

Obavijestite Vašeg liječnika ako uzimate bilo koji od sljedećih lijekova, jer oni mogu smanjiti učinak

Amprila:

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lijekovi za ublaţavanje boli i upale (tj. nesteroidni protuupalni lijekovi, kao što su ibuprofen ili

indometacin i acetilsalicilatna kiselina),

lijekovi za liječenje niskog krvnog tlaka, šoka, zatajenja srca, astme ili alergija, kao što su

efedrin, noradrenalin ili adrenalin. Liječnik će Vam trebati provjeriti krvni tlak.

Obavijestite Vašeg liječnika ako uzimate bilo koji od sljedećih lijekova, jer oni mogu povećati

vjerojatnost razvoja nuspojava ako ih uzimate s Amprilom:

lijekovi za ublaţavanje boli i upale (tj. nesteroidni protuupalni lijekovi, kao sto su ibuprofen ili

indometacin i acetilsalicilatna kiselina),

lijekovi za liječenje raka (kemoterapija),

lijekovi za sprječavanje odbacivanja organa nakon transplantacije, kao sto je ciklosporin,

diuretici (lijekovi koji potiču izlučivanje tekućine iz organizma), kao sto je furosemid,

steroidni lijekovi za liječenje upale, kao što je prednizolon,

alopurinol (koristi se za sniţavanje koncentracije urične kiseline u krvi),

prokainamid (za liječenje poteškoća sa srčanim ritmom),

trimetoprim sam ili u kombinaciji s kotrimoksazolom (za infekcije uzrokovane bakterijama)

temsirolimus (za liječenje raka),

sirolimus, everolimus (za sprječavanje odbacivanja presatka),

vildagliptin, saksagliptin ili linagliptin (za liječenje šećerne bolesti tipa 2),

racekadotril (za liječenje proljeva).

To se pogotovo primjenjuje ako takoĎer uzimate i:

lijekove koji se najčešće primjenjuju kako bi se izbjeglo odbacivanje presaĎenih organa

(sirolimus, everolimus i ostali lijekovi koji pripadaju skupini mTOR inhibitora). Pogledajte dio

„Upozorenja i mjere opreza“.

nadomjestke s kalijem ili zamjene za sol koje sadrţe kalij, diuretike (tablete za izmokravanje,

pogotovo takozvane tablete koje štede kalij), ostale lijekove koji mogu povisiti razinu kalija u

Vašoj krvi (poput heparina i kotrimoksazola koji je takoĎer poznat kao

trimetoprim/sulfametoksazol)

Liječnik će Vam moţda morati promijeniti dozu i/ili poduzeti druge mjere opreza ako uzimate neki

blokator angiotenzin II receptora (ARB) ili aliskiren (vidjeti takoĎer informacije pod naslovima

„Nemojte uzimati Ampril“ i „Upozorenja i mjere opreza“).

Obavijestite Vašeg liječnika ako uzimate bilo koji od sljedećih lijekova, jer Ampril moţe utjecati na

njihov učinak:

lijekovi za liječenje dijabetesa, kao što su oralni lijekovi za sniţavanje koncentracije glukoze u

krvi i inzulin. Ampril moţe dovesti do smanjenja koncentracije šećera u krvi, pa je potrebno

redovito provjeravati razinu šećera u krvi dok uzimate Ampril,

litij (za liječenje mentalnih poteškoća). Ampril moţe povisiti koncentraciju litija u krvi, pa je

potrebno da Vaš liječnik paţljivo prati koncentraciju litija.

Ako se bilo što od gore navedenog odnosi na Vas (ili niste sigurni), razgovarajte s liječnikom prije

uzimanja Amprila.

Ampril s hranom i pićem i alkoholom

Uzimanje alkohola s Amprilom moţe izazvati omaglicu ili ošamućenost. Ako ne znate koliko

smijete popiti dok uzimate Ampril, razgovarajte sa Vašim liječnikom s obzirom da lijekovi za

sniţavanje krvnog tlaka i alkohol mogu imati aditivni učinak.

Ampril se moţe uzeti sa ili bez hrane.

Trudnoća i dojenje

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se Vašem

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

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Trudnoća

Ne biste trebali uzimati ovaj lijek tijekom prvih 12 tjedana trudnoće, a ne smije se uopće uzimati

nakon 13-og tjedna budući da uzimanje ovog lijeka za vrijeme trudnoće moţe štetiti Vašem djetetu.

Ako zatrudnite za vrijeme uzimanja Amprila, odmah obavijestite Vašeg liječnika. Ako planirate

trudnoću, potrebno je unaprijed prijeći na primjerenu alternativnu terapiju.

Dojenje

Ne biste smjeli uzimati Ampril ako dojite.

Prije uzimanja bilo kojeg lijeka upitajte za savjet Vašeg liječnika ili ljekarnika.

Upravljanje vozilima i strojevima

Za vrijeme uzimanja Amprila moţete osjetiti omaglicu. Veća je vjerojatnost da se to dogodi na

početku liječenja ili kad uzmete višu dozu Amprila. Ako se to dogodi, nemojte upravljati vozilom niti

koristiti alate ili strojeve.

Ampril sadrži laktozu i natrij

Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se Vašem liječniku prije uzimanja

ovog lijeka.

Ovaj lijek sadrţi manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.

3.

Kako uzimati Ampril?

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik. Provjerite s Vašim

liječnikom ili ljekarnikom ako niste sigurni.

Kako uzeti lijek Ampril?

Lijek uzmite kroz usta u isto vrijeme svakog dana.

Tablete progutajte cijele, s tekućinom.

Nemojte drobiti niti ţvakati tablete.

Ampril moţete uzeti neovisno o obroku.

Koliko lijeka uzeti?

Liječenje visokog krvnog tlaka

Preporučena početna doza je 1,25 mg ili 2,5 mg jednom dnevno.

Liječnik će Vam prilagoditi dozu koju uzimate dok se ne postigne kontrola Vašeg krvnog tlaka.

Najveća dopuštena dnevna doza iznosi 10 mg dnevno.

Ako već uzimate diuretike (lijekove za mokrenje), liječnik će moţda smanjiti količinu ili

prekinuti uzimanje diuretika prije početka liječenja Amprilom.

Smanjenje rizika od srčanog ili moždanog udara

Uobičajena početna doza je 2,5 mg jednom dnevno.

Liječnik moţe kasnije odlučiti povisiti dozu koju uzimate.

Uobičajena doza je 10 mg jednom dnevno.

Liječenje u svrhu ublažavanja ili odgađanja pogoršanja poteškoća s bubrezima

Početna doza je 1,25 mg ili 2,5 mg jednom dnevno.

Liječnik će naknadno prilagoditi dozu koju uzimate.

Uobičajena doza je 5 mg ili 10 mg jednom dnevno.

Liječenje zatajenja srca

Uobičajena početna doza je 1,25 mg jednom dnevno.

Liječnik će naknadno prilagoditi dozu koju uzimate.

Najveća dopuštena dnevna doza iznosi 10 mg (poţeljno je lijek uzimati dvaput dnevno).

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Liječenje nakon srčanog udara

Uobičajena početna doza je 1,25 mg jednom dnevno do 2,5 mg dvaput dnevno.

Liječnik će naknadno prilagoditi dozu koju uzimate.

Najveća dopuštena dnevna doza iznosi 10 mg (poţeljno je lijek uzimati dvaput dnevno).

Stariji bolesnici

Liječnik će Vam smanjiti početnu dozu te će postupnije prilagoĎavati Vaše liječenje.

Ako uzmete više Amprila nego što ste trebali

Odmah obavijestite liječnika ili otiĎite na odjel hitne pomoći u najbliţu bolnicu. Nemojte sami voziti u

bolnicu, neka Vas poveze netko drugi ili pozovite hitnu pomoć. Uzmite sa sobom pakiranje lijeka

kako bi liječnik znao koji lijek ste uzeli.

Ako ste zaboravili uzeti Ampril

Ako propustite dozu, uzmite iduću tabletu u uobičajeno vrijeme.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Ampril

Nastavite uzimati lijek dok vam liječnik ne kaţe da prestanete. Nemojte prestati uzimati Ampril samo

zato što se osjećate bolje. Ako prestanete s uzimanjem lijeka, Vaša se bolest moţe vratiti.

Ako imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili

ljekarniku.

4.

Moguće nuspojave

Kao i svi lijekovi, ovaj lijek moţe uzrokovati nuspojave iako se one neće pojaviti kod svakoga.

Prestanite uzimati Ampril i odmah se obratite liječniku, ako primijetite bilo koju od sljedećih

nuspojava - možda će Vam biti potrebna i hitna medicinska skrb:

Oticanje lica, usana ili grla koje oteţava gutanje ili disanje, kao i svrbeţ i osip. To mogu biti

znakovi teške alergijske reakcije na Ampril.

Teške koţne reakcije, uključujući osip, ulceracije u ustima, pogoršanje postojećih koţnih

bolesti, crvenilo, mjehurići na koţi ili ljuštenje koţe (kao što je Stevens-Johnsonov sindrom,

toksična epidermalna nekroliza ili erythema multiforme).

Odmah obavijestite liječnika, ako osjetite nešto od sljedećeg:

Ubrzani puls, nepravilne ili snaţne otkucaje srca (palpitacije), bol u prsima, stezanje u prsima ili

ozbiljnije poteškoće uključujući srčani i moţdani udar.

Zadihanost ili kašalj. To mogu biti znakovi poteškoća s plućima.

Češća pojava modrica, duţe krvarenje od uobičajenog, bilo koji znakovi krvarenja (npr

krvarenje desni), ljubičaste točke na koţi ili pojava infekcija češće nego što je to uobičajeno,

bolno grlo i vrućica, osjećaj umora, nesvjestica, omaglica ili blijeda koţa. Ovo mogu biti

znakovi poteškoća s krvi ili koštanom srţi.

Jaki bolovi u trbuhu koji se mogu proširiti na leĎa. To moţe biti znak pankreatitisa (upala

gušterače).

Vrućica, osjećaj hladnoće, umor, gubitak apetita, bol u ţelucu, mučnina, ţutilo koţe ili očiju

(ţutica). To mogu biti znakovi poteškoća s jetrom kao što je hepatitis (upala jetre) ili oštećenje

jetre.

Ostale nuspojave uključuju:

Obavijestite Vašeg liječnika ako neke od sljedećih nuspojava postanu ozbiljne ili traju dulje od

nekoliko dana.

Nuspojave se mogu javiti odreĎenom učestalošću, što je definirano u nastavku:

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Česte (mogu se javiti u manje od 1 na 10 osoba)

Glavobolja ili osjećaj umora.

Omaglica. Češće se javlja na početku liječenja ili kod uzimanja veće doze Amprila.

Nesvjestica, hipotenzija (abnormalno nizak krvni tlak), osobito kod naglog sjedanja ili ustajanja.

Suhi, nadraţajni kašalj, upala sinusa (sinusitis) ili bronhitis, zadihanost.

Bol u ţelucu ili crijevima, proljev, poremećaji probave, mučnina.

Osip na koţi, s ili bez ispupčenja dijelova koţe.

Bol u prsima.

Grčevi ili bol u mišićima.

Povišena razina kalija u krvi (vidljiva krvnim pretragama).

Manje česte (mogu se javiti u manje od 1 na 100 osoba)

Problemi s ravnoteţom (vrtoglavica).

Svrbeţ i neuobičajeni osjećaji na koţi kao što su ukočenost, štipkanje, peckanje, vrućina ili trnci

(parestezija).

Gubitak ili poremećaj okusa.

Poteškoće sa snom.

Osjećaj depresije, napetosti, povećane nervoze ili nemira.

Začepljen nos, teškoće u disanju ili pogoršanje astme.

Nateknuće abdomena (intestinalni angioedem), uočljivo po simptomima kao što su bolovi u

trbuhu, povraćanje i proljev.

Ţgaravica, zatvor ili suha usta.

Povećano izlučivanje mokraće tijekom dana.

Znojenje jače od uobičajenog.

Gubitak ili smanjenje apetita (anoreksija).

Ubrzani ili nepravilni otkucaji srca.

Nateknute ruke i noge. To mogu biti znakovi da zadrţavate više vode nego je uobičajeno.

Crvenilo uz osjećaj vrućine.

Zamagljen vid.

Bol u zglobovima.

Vrućica.

Seksualna impotencija u muškaraca, smanjen nagon (libido) u muškaraca i ţena.

Povećan broj odreĎene vrste bijelih krvnih stanica (eozinofilija) vidljiv prilikom krvnih

pretraga.

Krvne pretrage pokazuju promjene u radu jetre, gušterače ili bubrega.

Rijetke (mogu se javiti u manje od 1 na 1000 osoba)

Osjećaj nesigurnosti ili zbunjenosti.

Crven i otečen jezik.

Jako ljuštenje ili guljenje koţe, osip praćen svrbeţom i kvrgama.

Poteškoće s noktima (npr. olabavljenost nokta ili odvajanje nokta iz leţišta).

Koţni osip ili pojava modrica na koţi.

Pojava točaka na koţi i hladnoća u udovima.

Crvene, nadraţene, nateknute oči koje svrbe ili suze.

Poremećaj sluha i zvonjava u ušima.

Osjećaj slabosti.

Krvne pretrage pokazuju smanjen broj crvenih ili bijelih krvnih stanica, trombocita ili smanjenu

koncentraciju hemoglobina.

Vrlo rijetke (mogu se javiti u manje od 1 na 10 000 osoba)

Veća osjetljivost na sunce nego inače (fotoosjetljivost).

Nepoznato: (učestalost se ne moţe procijeniti iz dostupnih podataka)

Koncentrirana mokraća (tamne boje), mučnina ili povraćanje, grčevi u mišićima, smetenost i

napadaji koji mogu biti posljedica neodgovarajućeg izlučivanja antidiuretskog hormona (ADH).

H A L M E D

31 - 01 - 2018

O D O B R E N O

Ako imate ove simptome, što prije se javite Vašem liječniku.

Ostale zabilježene nuspojave

Obavijestite Vašeg liječnika ako neke od sljedećih nuspojava postanu ozbiljne ili traju dulje od

nekoliko dana.

Poteškoće u koncentraciji.

Otečena usta.

Krvne pretrage pokazuju premali broj krvnih stanica u krvi.

Krvne pretrage pokazuju manju razinu natrija u krvi od uobičajene.

Prsti na nogama i rukama mijenjaju boju kada Vam je hladno uz osjećaj peckanja ili boli kada

se ugrijete (Raynaudov fenomen).

Povećanje grudi u muškaraca.

Usporena ili narušena sposobnost reakcije.

Osjećaj vrućine.

Poremećaj njuha.

Gubitak kose.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. To uključuje i

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave moţete prijaviti izravno putem

nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava moţete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Ampril?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ne čuvati na temperaturi iznad 25

Čuvati u originalnom pakiranju radi zaštite od vlage.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake

EXP. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte Vašeg ljekarnika kako

baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

Sadržaj pakiranja i druge informacije

Što Ampril sadrži?

Djelatna tvar je ramipril.

Ampril 1,25 mg tablete: Svaka tableta sadrţi 1,25 mg ramiprila.

Ampril 2,5 mg tablete: Svaka tableta sadrţi 2,5 mg ramiprila.

Ampril 5 mg tablete: Svaka tableta sadrţi 5 mg ramiprila.

Ampril 10 mg tablete: Svaka tableta sadrţi 10 mg ramiprila.

Drugi sastojci lijeka Ampril 1,25 mg tablete su natrijev hidrogenkarbonat, laktoza hidrat,

umreţenakarmelozanatrij, prethodno geliran škrob i natrijev stearilfumarat (pogledajte dio 2.

„Ampril sadrţi laktozu i natrij“).

Drugi sastojci lijeka Ampril 2,5 mg tablete su natrijev hidrogenkarbonat, laktoza hidrat,

umreţena karmelozanatrij, prethodno geliran škrob, natrijev stearilfumarat i ţuti ţeljezov oksid

(E172) (pogledajte dio 2. „Ampril sadrţi laktozu i natrij“).

Drugi sastojci lijeka Ampril 5 mg tablete su natrijev hidrogenkarbonat, laktoza hidrat, umreţena

karmelozanatrij, prethodno geliran škrob, natrijev stearilfumarat, ţuti ţeljezov oksid (E172) i

crveni ţeljezov oksid (E172) (pogledajte dio 2. „Ampril sadrţi laktozu i natrij“).

H A L M E D

31 - 01 - 2018

O D O B R E N O

Drugi sastojci lijeka Ampril 10 mg tablete su natrijev hidrogenkarbonat, laktoza hidrat,

umreţena karmelozanatrij, prethodno geliran škrob, i natrijev stearilfumarat (pogledajte dio 2.

„Ampril sadrţi laktozu i natrij“).

Kako Ampril izgleda i sadržaj pakiranja?

Ampril 1,25 mg tablete su bijele do gotovo bijele, ravne, ovalne tablete, dimenzija 8 x 4 mm.

Ampril 2,5 mg tablete su ţute, ravne, ovalne tablete, dimenzija 10 x 5 mm.

Ampril 5 mg tablete su ruţičaste, ravne, ovalne tablete, dimenzija 8,8 x 4,4 mm.

Ampril 10 mg tablete bijele do gotovo bijele, ravne, ovalne tablete, dimenzija 11,0 x 5,5 mm.

Ampril tablete su dostupne u kutijama s po 30 ili 60 tableta u blisterima.

Na trţištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja

KRKA - FARMA d.o.o., Radnička cesta 48, 10 000 Zagreb

ProizvoĎač

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u siječnju 2018.

H A L M E D

31 - 01 - 2018

O D O B R E N O

21-3-2019

Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips

Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips

The recall was initiated after it was discovered that a package of 10-ounce Original Potato Chips dated 10 AUG 2019 did not contain Original Potato Chips but instead contained Cheddar and Sour Cream Potato Chips which contain milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes which may have affected 660 bags of 10-ounce Original Potato Chips.

FDA - U.S. Food and Drug Administration

21-3-2019

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance pyridaben in tomatoes and aubergines. An MRL proposal of 0.15 mg/kg was derived for tomatoes and aubergines which reflects the intended use of the plant protection product containing pyridaben. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Published on: Tue, 19 Mar 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 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 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 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-3-2019

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC.

FDA - U.S. Food and Drug Administration

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

15-3-2019

Modification of the existing maximum residue level for fluopyram in broccoli

Modification of the existing maximum residue level for fluopyram in broccoli

Published on: Thu, 14 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance fluopyram in broccoli. The data submitted in support of the request were found to be sufficient to derive MRL proposals for broccoli. Adequate analytical methods for enforcement are available to control the residues of fluopyram on the commodit...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Staatssecretaris Blokhuis: komende jaren krijgen alle dak- en thuisloze jongeren hulp

Staatssecretaris Blokhuis: komende jaren krijgen alle dak- en thuisloze jongeren hulp

In een welvarend land als Nederland zou geen enkele jongere op straat moeten leven of noodgedwongen steeds op wisselende plekken verblijven. Met die ambitie lanceert staatssecretaris Paul Blokhuis (VWS) vandaag het Actieprogramma Dak- en Thuisloze Jongeren. De inspanningen moeten ertoe leiden dat alle ruim 10.000 dak- en thuisloze jongeren (tussen de 18 en 27 jaar) de komende jaren geholpen worden naar een zo zelfstandig mogelijk bestaan met een eigen thuis. En dat ook in de toekomst een nieuwe instroom ...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

14-3-2019

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Published on: Wed, 13 Mar 2019 The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive....

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Published on: Fri, 08 Mar 2019 The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary e...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Published on: Tue, 12 Mar 2019 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the fo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Published on: Tue, 12 Mar 2019 The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total orga...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Published on: Fri, 08 Mar 2019 The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019


Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the 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 Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Safety advisory – Section 19A product not for epidural or intrathecal use

Therapeutic Goods Administration - Australia

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

26-2-2019

UTZ Quality Foods Issues Allergy Alert on Undeclared Milk in Bachman 10 Ounce Twist

UTZ Quality Foods Issues Allergy Alert on Undeclared Milk in Bachman 10 Ounce Twist

Utz Quality Foods, LLC., is voluntarily recalling a specific expiration date code of Bachman 10 oz Twist Pretzel packages due to undeclared milk. This recall was initiated after reviewing production records which identified a small number of packages were mislabeled.

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

25-2-2019

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

FDA - U.S. Food and Drug Administration

21-2-2019


Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Europe - EMA - European Medicines Agency

15-2-2019

Toegang tot Wet langdurige zorg ook voor mensen met een psychische stoornis

Toegang tot Wet langdurige zorg ook voor mensen met een psychische stoornis

Mensen die hun leven lang intensieve geestelijke gezondheidszorg (GGZ) nodig hebben, kunnen vanaf 2021 toegang krijgen tot de Wet langdurige zorg (Wlz). Het gaat hierbij naar verwachting om 10.000 cliënten die permanent toezicht of 24 uur per dag zorg in de nabijheid nodig hebben en nu zorg en ondersteuning krijgen vanuit de Wet maatschappelijk ondersteuning of de Zorgverzekeringswet. De ministerraad heeft op voorstel van staatssecretaris Blokhuis van Volksgezondheid, Welzijn en Sport ingestemd met toeze...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-2-2019

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Thu, 14 Feb 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently describ...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-2-2019

Health Canada will be updating its safety review of breast implants

Health Canada will be updating its safety review of breast implants

OTTAWA - Health Canada will be updating its safety review of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) following an increase in reports of Canadian cases. As of January 1, 2019, Health Canada has received reports of 22 confirmed and 22 suspected Canadian cases of BIA-ALCL. In its initial safety review in 2017, Health Canada found that the rate of BIA-ALCL cases was low, with 5 confirmed Canadian cases of BIA-ALCL reported by Canadian manufacturers in the last 10 years. Increased...

Health Canada

9-2-2019

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

BIRDSEED FOOD CO. of Bend, OR is recalling Craft Granola Goldenola Turmeric & Ginger that was sold between the dates of 10/03/18 - 02/07/19, because it contains undeclared cashews. People who have an allergy or severe sensitivity to cashews run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

26-1-2019

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Published on: Fri, 25 Jan 2019 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6‐methylcoumarin [FL‐no: 13.012] and 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023] the concern for genotoxicity was ruled out. 6‐Methylc...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-3-2019

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Active substance: Lomitapide) - Transfer of orphan designation - Commission Decision (2019)2152 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004233

Europe -DG Health and Food Safety

18-3-2019


Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Europe - EMA - European Medicines Agency

13-3-2019

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (Active substance: dinutuximab beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2061 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3918/T/10

Europe -DG Health and Food Safety

7-3-2019

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1913 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4024/T/10

Europe -DG Health and Food Safety

1-3-2019

ACV meeting statement, Meeting 10, 3 October 2018

ACV meeting statement, Meeting 10, 3 October 2018

Advisory Committee on Vaccines meeting statement is now available

Therapeutic Goods Administration - Australia

25-2-2019

EU/3/10/732 (Southwood Research Limited)

EU/3/10/732 (Southwood Research Limited)

EU/3/10/732 (Active substance: Entinostat) - Transfer of orphan designation - Commission Decision (2019)1631 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004131

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/10/798 (Diurnal Europe B.V.)

EU/3/10/798 (Diurnal Europe B.V.)

EU/3/10/798 (Active substance: Synthetic double-stranded short interfering RNA oligonucleotide directed against proopiomelanocortin) - Transfer of orphan designation - Commission Decision (2019)1360 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003061

Europe -DG Health and Food Safety

13-2-2019


Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Europe - EMA - European Medicines Agency

1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474

Europe -DG Health and Food Safety

28-1-2019


Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

25-1-2019


Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Europe - EMA - European Medicines Agency

23-1-2019

EU/3/10/777 (Voisin Consulting S.A.R.L.)

EU/3/10/777 (Voisin Consulting S.A.R.L.)

EU/3/10/777 (Active substance: Cyclic pyranopterin monophosphate) - Transfer of orphan designation - Commission Decision (2019)574 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003164

Europe -DG Health and Food Safety

22-1-2019

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Active substance: Tasimelteon) - Transfer of orphan designation - Commission Decision (2019)573 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002557

Europe -DG Health and Food Safety