Ampril HD 5 mg 25 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Ampril HD 5 mg/25 mg tablete
  • Doziranje:
  • 5 mg + 25 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: svaka tableta sadrži 5 mg ramiprila i 25 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 HD 5 mg/25 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-638598704-01]; 60 tableta u blisteru, u kutiji [HR-H-638598704-02] 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-638598704
  • 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 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

21-3-2019

FDA Announces New Date for Webinar on Genome Editing in Animals

FDA Announces New Date for Webinar on Genome Editing in Animals

On April 25, 2019, FDA CVM, with participation from the CBER, will hold a public webinar about genome editing in animals, an innovative and rapidly evolving technology that offers significant public health benefits.

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

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

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

26-2-2019

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Published on: Mon, 25 Feb 2019 No abstract available. © European Food Safety Authority, 2015 Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

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

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

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

Guidelines for reporting molecular typing data through EFSA's Data Collection Framework

Guidelines for reporting molecular typing data through EFSA's Data Collection Framework

Published on: Fri, 25 Jan 2019 The European Food Safety Authority (EFSA) received the mandate from the European Commission (EC), in accordance with Article 31 of Regulation (EC) No. 178/2002, to collect data on the molecular testing of food‐borne pathogens such as Salmonella, Listeria monocytogenes and Shiga toxin‐producing Escherichia coli (STEC) from food, feed, animals and the related environment, to contribute to the epidemiological investigations of food‐borne outbreaks and to the identification of...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Published on: Fri, 25 Jan 2019 Based on the risk assessment of genetically modified plants, according to Implementing Regulation (EU) No 503/201321 “In cases when known functional aspects of the newly expressed protein or structural similarity to known strong adjuvants may indicate possible adjuvant activity, the applicant shall assess the possible role of these proteins as adjuvants”. To further investigate the topic, an EFSA procurement was launched requesting a comprehensive literature review and cri...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Overview of available toxicity data for calystegines

Overview of available toxicity data for calystegines

Published on: Fri, 25 Jan 2019 Calystegines are polyhydroxylated nortropane alkaloids that have been found in various solanaceous foods, in particular in potatoes and aubergines. The biological activity and potential toxicity of calystegines are associated with their capacity to inhibit glycosidases and block carbohydrate metabolism inducing lysosomal storage toxicity. The present report summarises the retrieved information on the possible toxicity of calystegines. Only few in vivo short‐term toxicologi...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast:  https://bit.ly/2WgkmGC   March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0   #FDA #MedicalDevicepic.twitter.com/zvhd7

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast: https://bit.ly/2WgkmGC  March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0  #FDA #MedicalDevicepic.twitter.com/zvhd7

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast: https://bit.ly/2WgkmGC  March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0  #FDA #MedicalDevice pic.twitter.com/zvhd72SyxX

FDA - U.S. Food and Drug Administration

21-3-2019

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevicepic.twitter.com/Wh9Sshjn6n

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevicepic.twitter.com/Wh9Sshjn6n

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevice pic.twitter.com/Wh9Sshjn6n

FDA - U.S. Food and Drug Administration

18-3-2019


Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Europe - EMA - European Medicines Agency

13-3-2019

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2065 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2644/T/25

Europe -DG Health and Food Safety

8-3-2019

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to ACMS/ACCS meetings held in November 2018

Therapeutic Goods Administration - Australia

25-2-2019

Vabomere (Menarini International Operations Luxembourg S.A.)

Vabomere (Menarini International Operations Luxembourg S.A.)

Vabomere (Active substance: meropenem/vaborbactam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1591 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004669/T/0001

Europe -DG Health and Food Safety

25-2-2019

Zulvac BTV (Zoetis Belgium S.A.)

Zulvac BTV (Zoetis Belgium S.A.)

Zulvac BTV (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)) - Centralised - Variation - Commission Decision (2019)1607 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4185/X/01

Europe -DG Health and Food Safety

25-2-2019

EU/3/17/1880 (Chemocentryx Ireland Limited)

EU/3/17/1880 (Chemocentryx Ireland Limited)

EU/3/17/1880 (Active substance: Avacopan) - Transfer of orphan designation - Commission Decision (2019)1618 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004221

Europe -DG Health and Food Safety

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

25-2-2019

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Active substance: Chimeric monoclonal antibody to shiga-toxin 1 and 2) - Transfer of orphan designation - Commission Decision (2019)1636 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003835

Europe -DG Health and Food Safety

25-2-2019

EU/3/05/288 (Teva  GmbH)

EU/3/05/288 (Teva GmbH)

EU/3/05/288 (Active substance: 4-[3-(methylsulfonyl)phenyl]-1-propylpiperidine x HCl) - Transfer of orphan designation - Commission Decision (2019)1635 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003804

Europe -DG Health and Food Safety

25-2-2019

EU/3/16/1674 (Bellicum Pharma GmbH)

EU/3/16/1674 (Bellicum Pharma GmbH)

EU/3/16/1674 (Active substance: Allogeneic donor-derived ex-vivo expanded T lymphocytes transduced with a retroviral vector containing inducible caspase 9 and truncated CD19) - Transfer of orphan designation - Commission Decision (2019)1630 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004083

Europe -DG Health and Food Safety

25-2-2019

EU/3/16/1666 (Bellicum Pharma GmbH)

EU/3/16/1666 (Bellicum Pharma GmbH)

EU/3/16/1666 (Active substance: Rimiducid) - Transfer of orphan designation - Commission Decision (2019)1629 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004057

Europe -DG Health and Food Safety

25-2-2019

EU/3/15/1526 (Ultragenyx Netherlands B.V.)

EU/3/15/1526 (Ultragenyx Netherlands B.V.)

EU/3/15/1526 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2019)1632 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003558

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2019)1626 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003556

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2019)1634 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003636

Europe -DG Health and Food Safety

25-2-2019

EU/3/18/2026 (Alnylam Netherlands B.V.)

EU/3/18/2026 (Alnylam Netherlands B.V.)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)1637 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/O...

Europe -DG Health and Food Safety

25-2-2019

EU/3/15/1518 (Novartis Europharm Limited)

EU/3/15/1518 (Novartis Europharm Limited)

EU/3/15/1518 (Active substance: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1628 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003549

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Active substance: Adenovirus associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1627 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003485

Europe -DG Health and Food Safety

25-2-2019

EU/3/16/1637 (Alnylam Netherlands B.V.)

EU/3/16/1637 (Alnylam Netherlands B.V.)

EU/3/16/1637 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)1633 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003680

Europe -DG Health and Food Safety

25-2-2019

BLUEVAC BTV8 (CZ Veterinaria, S.A.)

BLUEVAC BTV8 (CZ Veterinaria, S.A.)

BLUEVAC BTV8 (Active substance: Bluetongue virus inactivated, serotype 8) - Centralised - Yearly update - Commission Decision (2019)1610 of Mon, 25 Feb 2019

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1259 (Insmed Netherlands B.V.)

EU/3/14/1259 (Insmed Netherlands B.V.)

EU/3/14/1259 (Active substance: Amikacin sulfate) - Transfer of orphan designation - Commission Decision (2019)1625 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003885

Europe -DG Health and Food Safety

25-2-2019

EU/3/06/387 (Insmed Netherlands B.V.)

EU/3/06/387 (Insmed Netherlands B.V.)

EU/3/06/387 (Active substance: Amikacin sulfate (liposomal)) - Transfer of orphan designation - Commission Decision (2019)1624 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003770

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1373 (Chemocentryx Ireland Limited)

EU/3/14/1373 (Chemocentryx Ireland Limited)

EU/3/14/1373 (Active substance: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide) - Transfer of orphan designation - Commission Decision (2019)1619 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004220

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1372 (Chemocentryx Ireland Limited)

EU/3/14/1372 (Chemocentryx Ireland Limited)

EU/3/14/1372 (Active substance: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide) - Transfer of orphan designation - Commission Decision (2019)1620 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004218

Europe -DG Health and Food Safety

22-2-2019


Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Europe - EMA - European Medicines Agency

18-2-2019

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

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

Imatinib Accord (Active substance: Imatinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1434 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2681/T/25

Europe -DG Health and Food Safety

15-2-2019

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here:  https://go.usa.gov/xEUeu  #Medi

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu  #Medi

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

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