Ampril HL 2 5 mg 12 5

Glavna informacija

  • Trgovački naziv:
  • Ampril HL 2,5 mg/12,5 mg tablete
  • Doziranje:
  • 2,5 mg + 12,5 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: svaka tableta sadrži 2,5 mg ramiprila i 12,5 mg hidroklorotiazida
  • 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 HL 2,5 mg/12,5 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-453067077-01]; 60 tableta u blisteru, u kutiji [HR-H-453067077-02] Urbroj: 381-12-01/30-18-05

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-453067077
  • Datum autorizacije:
  • 31-01-2018
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Ampril HL 2,5 mg/12,5 mg tablete

Ampril HD 5 mg/25 mg tablete

ramipril/hidroklorotiazid

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

podatke.

Sačuvajte ovu uputu. Možda 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. Može 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 su Ampril HL i Ampril HD i za što se koriste?

Što morate znati prije nego počnete uzimati Ampril HL i Ampril HD?

Kako uzimati Ampril HL i Ampril HD?

Moguće nuspojave

Kako čuvati Ampril HL i Ampril HD?

Sadržaj pakiranja i druge informacije

1.

Što su Ampril HL i Ampril HD i za što se koriste?

Ampril HL i Ampril HD su kombinacija dvaju lijekova koji se zovu ramipril i hidroklorotiazid.

Ramipril pripada u skupinu lijekova koje zovemo „ACE inhibitori“ (Inhibitori angiotenzin

konvertirajućeg enzima). Djeluje tako da:

smanjuje stvaranje tvari koje povisuju krvni tlak u Vašem tijelu.

čini Vaše krvne žile opuštenijima i širima.

olakšava Vašem srcu pumpanje krvi po tijelu.

Hidroklorotiazid pripada skupini lijekova koje zovemo „tiazidski diuretici“ ili „tablete za

izmokravanje“. Djeluje tako da povećava količinu vode (urina) koju izlučujete. To snižava Vaš krvni

tlak.

Ampril HL i Ampril HD se koriste za liječenje visokog krvnog tlaka. Dvije djelatne tvari zajedno

snižavaju krvni tlak. Koriste se zajedno kada liječenje samo jednom od tih tvari nije bilo uspješno.

2.

Što morate znati prije nego počnete uzimati Ampril HL i Ampril HD?

Nemojte uzimati Ampril HL i Ampril HD

Ako ste alergični na ramipril, hidroklorotiazid ili neki drugi sastojak ovog lijeka (naveden u

dijelu 6.).

Ako ste alergični na lijekove slične Amprilu HL i Amprilu HD (drugi ACE inhibitori ili lijekovi

derivati sulfonamida).

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

usana, lica, grla ili jezika.

Ako ste ikad imali ozbiljnu alergijsku reakciju zvanu angioedem. Znakovi uključuju svrbež,

osip (urtikarija), crvene mrlje po rukama, stopalima i vratu, oticanje grla i jezika, oticanje oko

očiju i usana, otežano disanje i gutanje.

Ako ste na dijalizi ili nekom drugom obliku filtracije krvi. Ovisno o aparatu koji se pri tom

koristi, Ampril HL i Ampril HD možda nisu pogodni za Vas.

Ako imate teško oštećenje jetre.

Ako imate abnormalne količine soli u krvi (kalcij, kalij, natrij).

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Ako imate problema s bubrezima, pri čemu je smanjena opskrba bubrega krvlju (stenoza

bubrežne arterije).

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

Ako dojite (vidjeti dio „Trudnoća i dojenje“).

Ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje

krvnog tlaka koji sadrži aliskiren.

Nemojte uzimati Ampril HL i Ampril HD ako se išta od gore navedenog odnosi na Vas. Ako niste

sigurni, razgovarajte s Vašim liječnikom prije uzimanja Amprila HL i Amprila HD.

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Ampril HL i Ampril HD:

Ako imate problema 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 predviđeno liječenje koje smanjuje alergijski učinak uboda pčele ili ose

(desenzibilizacija).

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

možda trebati prekinuti liječenje Amprilom HL i Amprilom HD jedan dan prije; upitajte

liječnika za savjet.

Ako imate visoku koncentraciju kalija u krvi (vidljivu u rezultatima krvnih pretraga).

Ako uzimate lijekove ili imate stanja koja mogu smanjiti razinu natrija u krvi. Vaš liječnik može

provoditi redovite krvne pretrage, osobito za provjeru razine natrija u krvi, pogotovo ako ste

stariji.

Ako uzimate bilo koji od sljedećih lijekova, povećava se rizik od razvoja angioedema (brzo

oticanje potkožnog tkiva u području poput grla):

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

kako bi se izbjeglo odbacivanje presađenih organa),

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

racekadotril.

Ako imate vaskularnu bolest vezivnog tkiva kao što je skleroderma ili sistemski lupus

eritematozus.

Ako ste trudni ili mislite da biste mogli zatrudnjeti morate obavijestiti Vašeg liječnika. Ampril

HL i Ampril HD se ne preporučuju u prva tri mjeseca trudnoće, a može ozbiljno naštetiti Vašem

djetetu nakon trećeg mjeseca trudnoće (vidjeti dio „Trudnoća i dojenje“).

Ako Vam se vid pogorša ili imate bol u oku, osobito ako kod Vas postoji rizik razvoja stanja

zvanog glaukom ili ste alergični na lijekove koji sadrže penicilin ili sulfonamide.

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 bubrežne tegobe povezane sa šećernom

bolešću.

aliskiren.

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

u redovitim intervalima.

Vidjeti također informacije pod naslovom „Nemojte uzimati Ampril HL i Ampril HD“.

Djeca i adolescenti

Ampril HL i Ampril HD se ne preporučuju djeci i adolescentima mlađim od 18 godina, jer lijek nije

primjenjivan u toj dobnoj skupini.

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

uzimanja Amprila HL i Amprila HD.

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Drugi lijekovi i Ampril HL i Ampril HD

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

druge lijekove. Ampril HL i Ampril HD mogu utjecati na učinak drugih lijekova, a drugi lijekovi

mogu također utjecati na učinak Amprila HL i Amprila HD.

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

Amprila HL i Amprila HD:

Lijekovi za ublažavanje boli i upale (tj. nesteroidni protuupalni lijekovi, NSAID, kao što su

ibuprofen ili indometacin i acetilsalicilna 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 HL i Amprilom HD:

Lijekovi za ublažavanje boli i upale (tj. nesteroidni protuupalni lijekovi, NSAID, kao što su

ibuprofen ili indometacin i acetilsalicilna kiselina).

Lijekovi koji mogu smanjiti količinu kalija u krvi, uključujući lijekove protiv zatvora, diuretike

(tablete za izmokravanje), amfotericin B (koristi se za liječenje gljivičnih infekcija) i ACTH

(koristi se za provjeru aktivnosti nadbubrežnih žlijezda).

Lijekovi za liječenje raka (kemoterapija).

Lijekovi za liječenje srčanih tegoba, uključujući poteškoće s otkucajima srca.

Lijekovi za sprječavanje odbacivanja organa nakon transplantacije, kao što je ciklosporin.

Diuretici (lijekovi koji potiču izlučivanje tekućine iz organizma), na primjer furosemid.

Steroidni lijekovi za liječenje upale, kao što je prednizolon.

Nadomjesci kalcija.

Alopurinol (koristi se za snižavanje koncentracije urične kiseline u krvi).

Prokainamid (za liječenje poteškoća sa srčanim ritmom).

Kolestiramin (za smanjenje količine masnoća u krvi).

Karbamazepin (za liječenje epilepsije).

Heparin (koristi se za razrjeđivanje krvi).

Trimetoprim sam ili u kombinaciji s kotrimoksazolom (za liječenje infekcija uzrokovanih

bakterijama),

Temsirolimus (za liječenje raka).

Everolimus (za sprečavanje odbacivanja presatka).

Vildagliptin, saksagliptin ili linagliptin (koriste se za liječenje dijabetesa tipa 2).

Racekadotril (za liječenje proljeva).

To se pogotovo primjenjuje ako uzimate i:

lijekove koji se najčešće primjenjuju kako bi se izbjeglo odbacivanje presađenih 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 sadrže 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 također poznat kao

trimetoprim/sulfametoksazol).

Obavijestite Vašeg liječnika ako uzimate bilo koji od sljedećih lijekova, jer Ampril HL i Ampril HD

mogu utjecati na njihov učinak:

Lijekovi za liječenje šećerne bolesti, kao što su oralni lijekovi za snižavanje koncentracije

glukoze u krvi i inzulin. Ampril HL i Ampril HD mogu dovesti do smanjenja koncentracije

šećera u krvi, pa je potrebno redovito provjeravati razinu šećera u krvi dok uzimate Ampril HL i

Ampril HD.

Litij (za liječenje mentalnih problema). Ampril HL i Ampril HD mogu povisiti koncentraciju

litija u krvi pa je potrebno da Vaš liječnik pažljivo prati koncentraciju litija.

Lijekovi za opuštanje mišića.

Kinin (za liječenje malarije).

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Lijekovi koji sadržavaju jod a koriste se prilikom rendgenskog ili CT pregleda u bolnici.

Penicilin (za liječenje infekcija).

Lijekovi za razrjeđivanje krvi koji se uzimaju kroz usta (oralni antikoagulansi), kao što je

varfarin.

Liječnik će Vam možda morati promijeniti dozu i/ili poduzeti druge mjere opreza:

ako uzimate neki blokator angiotenzin II receptora (ARB) ili aliskiren (pogledajte također

informacije pod naslovima „Nemojte uzimati Ampril HL i HD“ i „Upozorenja i mjere opreza“).

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

uzimanja Amprila HL i Amprila HD.

Pretrage

Posavjetujte se s Vašim liječnikom ili ljekarnikom prije uzimanja lijeka:

Ako trebate obaviti ispitivanje funkcije paratireoidne žlijezde. Ampril HL i Ampril HD mogu

utjecati na rezultate pretrage.

Ako ste sportaš i trebate obaviti anti-doping test. Ampril HL i Ampril HD mogu dati pozitivan

rezultat testa.

Ampril HL i Ampril HD s hranom i pićem i alkoholom

Uzimanje alkohola s Amprilom HL i Amprilom HD može izazvati omaglicu ili ošamućenost.

Ako ne znate koliko smijete popiti dok uzimate Ampril HL i Ampril HD, razgovarajte s Vašim

liječnikom budući da lijekovi za snižavanje krvnog tlaka i alkohol mogu imati aditivni učinak.

Ampril HL i Ampril HD se mogu uzeti uz obrok ili između obroka.

Trudnoća i dojenje

Trudnoća

Ako mislite da ste trudni ili da biste mogli zatrudnjeti, morate obavijestiti Vašeg liječnika.

Ne preporučuje se uzimati Ampril HL i Ampril HD tijekom prvih 12 tjedana trudnoće, a ne smije se

uopće uzimati nakon 13-og tjedna budući da uzimanje Amprila HL i Amprila HD za vrijeme trudnoće

mogu biti štetni za dijete.

Ako zatrudnite za vrijeme uzimanja Amprila HL i Amprila HD, odmah obavijestite Vašeg liječnika.

Ako planirate trudnoću, potrebno je unaprijed prijeći na primjerenu alternativnu terapiju.

Dojenje

Ne biste smjeli uzimati Ampril HL i Ampril HD ako dojite.

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

Upravljanje vozilima i strojevima

Savjetujemo vam da ne vozite automobil niti da upravljate strojevima dok ne saznate kako Ampril HL

i Ampril HD djeluje na Vas. Za vrijeme uzimanja Amprila HL i Amprila HD možete osjetiti omaglicu.

Veća je vjerojatnost da se to dogodi na početku liječenja ili kad uzmete veću dozu Amprila HL i

Amprila HD. Ako se to dogodi, nemojte upravljati vozilom i nemojte koristiti alate ili strojeve.

Ampril HL i Ampril HD sadrže laktozu i natrij

Ako Vam je liječnik rekao da imate bolest nepodnošenja nekih šećera, prije nego što počnete uzimati

ovaj lijek posavjetujete se s Vašim liječnikom.

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

3.

Kako uzimati Ampril HL i Ampril HD?

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

liječnikom ili ljekarnikom ako niste sigurni.

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Uobičajena doza iznosi 1 tabletu Amprila HL (2,5 mg ramiprila i 12,5 mg hidroklorotiazida) ujutro.

Doza se prema potrebi, ali najranije poslije tri tjedna, može povećati na 1 tabletu Amprila HD (5 mg

ramiprila i 25 mg hidroklorotiazida) ujutro.

Maksimalna doza je 5 mg ramiprila i 25 mg hidroklorotiazida.

Kako uzeti lijek Ampril?

Lijek uzmite kroz usta, svaki dan u isto vrijeme, obično ujutro.

Tablete progutajte s tekućinom.

Nemojte drobiti ili žvakati tablete.

Koliko lijeka uzeti?

Liječenje visokog krvnog tlaka

Liječnik će prilagoditi dozu koju uzimate tako da Vaš krvni tlak bude pod kontrolom.

Stariji bolesnici

Liječnik će smanjiti početnu dozu i postupno prilagođavati Vašu terapiju.

Ako uzmete više Amprila HL i Amprila HD nego što ste trebali

Obavijestite liječnika ili odmah otiđite u najbližu bolnicu. Nemojte sami voziti u bolnicu, neka Vas

poveze netko drugi ili pozovite hitnu pomoć. Uzmite sa sobom pakiranje lijeka kako bi liječnik znao

što ste uzeli.

Ako ste zaboravili uzeti Ampril HL i Ampril HD

Ako zaboravite uzeti dozu, slijedeću dozu uzmite u uobičajeno vrijeme.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

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 može uzrokovati nuspojave iako se one neće pojaviti kod svakoga.

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

Prestanite uzimati Ampril HL i Ampril HD i odmah se obratite liječniku, ako primijetite bilo

koju od sljedećih teških nuspojava – možda će vam biti potrebna i hitna medicinska skrb:

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

znakovi teške alergijske reakcije na Ampril HL i Ampril HD.

Teške kožne reakcije, uključujući osip, ulceracije u ustima, pogoršanje postojećih kožnih

bolesti, crvenilo, mjehurići na koži ili ljuštenje kože (kao što je Stevens-Johnsonov sindrom,

toksična epidermalna nekroliza ili eritema multiforme).

Odmah obavijestite liječnika, ako osjetite nešto od sljedećeg:

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

ozbiljne poteškoće uključujući srčani udar i moždani udar.

Kratkoća daha, vrućicu uz kašalj koja traje 2 do 3 dana te smanjeni apetit. To mogu biti znakovi

poteškoća s plućima uključujući upalu.

Lakše nastajanje modrica, krvarenje koje traje dulje od uobičajenog, bilo kakvi znakovi

krvarenja (npr. krvarenje desni), ljubičaste točke na koži ili infekcije češće nego što je to

uobičajeno, bolno grlo i vrućica, osjećaj umora, nesvjestica, omaglica ili blijeda koža. To mogu

biti znakovi poteškoća s krvi ili koštanom srži.

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Jaki bolovi u želucu koji se mogu proširiti na leđa. To može biti znak pankreatitisa (upale

gušterače).

Vrućica, zimica, umor, gubitak apetita, bol u želucu, mučnina, žutilo kože ili očiju (žutica). To

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

Ostale nuspojave

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

dana.

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

Glavobolja, osjećaj slabosti ili umora.

Omaglica. Ona se češće javlja na početku liječenja Amprilom HL i Amprilom HD ili kada

počnete uzimati više doze.

Suhi, nadražajni kašalj ili bronhitis.

Povećana razina šećera u krvi, vidljiva krvnim pretragama. Ako imate šećernu bolest, može se

pogoršati.

Povećana razina urične kiseline ili masti u krvi, vidljiva krvnim pretragama.

Bolni, crveni i nateknuti zglobovi.

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

Osip na koži s ili bez ispupčenih dijelova kože.

Crvenilo uz osjećaj vrućine, nesvjestica, hipotenzija (abnormalno nizak krvni tlak), osobito kod

naglog ustajanja ili sjedanja.

Poteškoće s ravnotežom (vrtoglavica).

Svrbež i neuobičajeni osjeti na koži kao što su ukočenost, žarenje, peckanje, vrućina ili trnci

(parestezija).

Gubitak ili poremećaj okusa.

Poteškoće sa snom.

Osjećaj depresije, napetosti, povećane nervoze ili nemira.

Začepljen nos, upala sinusa (sinusitis), zadihanost.

Upala desni (gingivitis), otečena usta.

Crvene, nadražene, otečene ili vodenaste oči.

Zvonjava u ušima.

Zamućen vid.

Gubitak kose.

Bol u prsima.

Bol u mišićima.

Zatvor, bol u želucu ili crijevima.

Poremećaj probave ili mučnina.

Povećano izlučivanje tekućine (mokraće) tijekom dana.

Znojenje jače od uobičajenog i osjećaj žeđi.

Gubitak ili smanjenje apetita (anoreksija), smanjen osjećaj gladi.

Ubrzani ili nepravilni otkucaji srca.

Otečene ruke i noge. To mogu biti znakovi da zadržavate više vode nego je uobičajeno.

Vrućica.

Seksualna impotencija u muškaraca.

Krvne pretrage pokazuju smanjenje broja crvenih ili bijelih krvnih stanica te trombocita ili

koncentracije hemoglobina.

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

Krvne pretrage pokazuju nižu razinu kalija u krvi od uobičajene.

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

Mučnina, proljev ili žgaravica.

Crven i otečen jezik ili suha usta.

Krvne pretrage pokazuju višu razinu kalija u krvi od uobičajene.

H A L M E D

31 - 01 - 2018

O D O B R E N O

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

Koncentrirana mokraća (tamne boje), osjećaj mučnine ili mučnina, grčevi u mišićima, smetenost

i napadaji koji mogu nastati zbog neodgovarajućeg izlučivanja antidiuretskog hormona (ADH).

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

Ostale zabilježene nuspojave

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

dana.

Poteškoće u koncentraciji, nemir ili zbunjenost.

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

se ugrijete. To bi mogao biti Raynaudov fenomen.

Povećanje grudi u muškaraca.

Krvni ugrušci.

Poremećaj sluha.

Manje suzenje očiju od uobičajenog.

Objekti izgledaju žućkasto.

Dehidracija.

Oticanje, bol i crvenilo obraza (upala žlijezde slinovnice).

Oticanje crijeva zvano „intestinalni angioedem“ uz simptome kao što su bol u trbuhu,

povraćanje i proljev.

Pojačana osjetljivost na sunce.

Teško ljuštenje ili guljenje kože, osip praćen svrbežom i kvrgama ili druge kožne reakcije kao

što je crveni osip na licu i čelu.

Kožni osip ili modrice.

Mrlje na koži i hladni ekstremiteti.

Poteškoće s noktima (npr. klimavost nokta ili odvajanje nokta iz ležišta).

Mišićno-koštana ukočenost ili nemogućnost pomicanja vilice (tetanija).

Slabost ili grčevi u mišićima.

Smanjena seksualna želja u muškaraca ili žena.

Krv u mokraći, što može biti znak poteškoća s bubrezima (intersticijski nefritis).

Povećana razina šećera u mokraći.

Povećan broj određene vrste bijelih krvnih stanica (eozinofilija) vidljiv prilikom provođenja

krvnih pretraga.

Krvne pretrage pokazuju premali broj krvnih stanica u krvi (pancitopenija).

Krvne pretrage pokazuju promjenu razine elektrolita kao što su natrij, kalcij, magnezij i klorid u

krvi.

Usporena ili narušena sposobnost reakcije.

Poremećaj njuha.

Poteškoće pri disanju ili pogoršanje astme.

smanjeno suzenje oka

jaka bol u oku, zamagljen vid ili viđenje aureola (svjetlost ovalnog oblika, svijetleći prsten) oko

svjetala, glavobolja, obilno suzenje ili mučnina i povraćanje koji mogu upućivati na stanje

zvano glaukom.

Prijavljivanje nuspojava

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

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti

izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Ampril HL i Ampril HD?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ne čuvati na temperaturi iznad 30

H A L M E D

31 - 01 - 2018

O D O B R E N O

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 HL i Ampril HD sadrže?

Djelatne tvari su ramipril i hidroklorotiazid.

Svaka Ampril HL tableta sadrži 2,5 mg ramiprila i 12,5 mg hidroklorotiazida.

Svaka Ampril HD tableta sadrži 5 mg ramiprila i 25 mg hidroklorotiazida.

Drugi sastojci su natrijev hidrogenkarbonat, laktoza hidrat, umrežena karmelozanatrij,,

prethodno geliran škrob i natrijev stearilfumarat. Pogledajte dio 2. „Ampril HL i Ampril HD

sadrže laktozu i natrij“.

Kako Ampril HL i Ampril HD izgledaju i sadržaj pakiranja?

Ampril HL 2,5 mg/12,5 mg tablete su bijele do gotovo bijele, dimenzije 4,0 x 8,0 mm, neobložene,

plosnate tablete u obliku kapsule s urezom s jedne strane i označene brojkom 12,5. Urez služi samo

kako bi se olakšalo lomljenje tablete radi lakšeg gutanja, a ne da bi se podijelila na jednake doze.

Ampril HD 5 mg/25 mg tablete su bijele do gotovo bijele, dimenzije 5,0 x 10,0 mm, neobložene,

plosnate tablete u obliku kapsule, s urezom s jedne strane i na bočnim plohama, označene brojkom 25.

Tableta se može razdijeliti na jednake doze.

Ampril HL i Ampril HD su dostupni u kutijama s po 30 ili 60 tableta u blisterima.

Na tržištu 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

17-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

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

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

FDA approves new drug to treat influenza

FDA approves new drug to treat influenza

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

FDA - U.S. Food and Drug Administration

23-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

FDA - U.S. Food and Drug Administration

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

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Enforcement Report for the Week of September 12, 2018

Enforcement Report for the Week of September 12, 2018

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

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

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 Denmark and EFSA – Final report

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

22-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

8-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

1-10-2018

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

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

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

Europe -DG Health and Food Safety

1-10-2018

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

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

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

Europe -DG Health and Food Safety

26-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

19-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency

12-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

11-9-2018

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

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

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

Europe - EMA - European Medicines Agency

5-9-2018

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

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

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

FDA - U.S. Food and Drug Administration