Blocar Plus 2 5 mg + 12 5 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Blocar Plus 2,5 mg + 12,5 mg tablete
  • Doziranje:
  • 2,5 mg + 12,5 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna 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:
  • Jadran Galenski laboratorij d.d., Rijeka, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Blocar Plus 2,5 mg + 12,5 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-319769403-01] Urbroj: 381-12-01/70-15-11

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-319769403
  • Datum autorizacije:
  • 29-04-2015
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Blocar Plus 2,5 mg + 12,5 mg tablete

Blocar Plus 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 ponovno 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 je Blocar Plus i za što se koristi?

Što morate znati prije nego počnete uzimati Blocar Plus?

Kako uzimati Blocar Plus?

Moguće nuspojave

Kako čuvati Blocar Plus?

Sadržaj pakiranja i druge informacije

1. Što je Blocar Plus i za što se koristi?

Blocar

Plus

tablete

sadrže

kombinaciju

dvije

djelatne

tvari

koje

zovu

ramipril

hidroklorotiazid.

Ramipril pripada skupini

lijekova koji se zovu

„ACE inhibitori" (Angiotensin Converting

Enzyme - angiotenzin konvertirajući enzim inhibitori). Djeluje tako da:

smanjuje u Vašem tijelu stvaranje tvari koje povisuju krvni tlak,

čini Vaše krvne žile opuštenijima i širima,

olakšava Vašem srcu pumpanje krvi kroz tijelo.

Hidroklorotiazid pripada skupini lijekova koji se zovu „tiazidski diuretici“ ili „tablete za vodu“.

Djeluje tako da povećava količinu mokraće (urina) koju izlučujete te na taj način snižava krvni

tlak.

Blocar Plus se koristi za liječenje povišenog krvnog tlaka. Dvije djelatne tvari zajedno snizuju

krvni tlak. Koriste se u kombinaciji kad liječenje samo jednom od tih tvari nije bilo uspješno.

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2. Što morate znati prije nego počnete uzimati Blocar Plus?

Nemojte uzimati Blocar Plus

ako ste alergični (preosjetljivi) na djelatne tvari (ramipril, hidroklorotiazid) ili neki drugi

sastojak ovog lijeka (naveden u dijelu 6.),

ako ste alergični (preosjetljivi) na lijekove slične Blocar Plus-u (drugi ACE inhibitori ili

lijekovi derivati sulfonamida),

Znaci 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“. Znaci te reakcije

uključuju svrbež, osip (koprivnjaču), crvene mrlje po rukama, stopalima i vratu, oticanje grla

i jezika, oticanje oko očiju i usana, teškoće u disanju i gutanju.

ako idete na dijalizu ili neki drugi oblik filtracije krvi. Ovisno o aparatu koji se pri tom

koristi, Blocar Plus možda nije pogodan za Vas.

ako imate ozbiljnih problema s jetrom,

ako imate nenormalne količine soli u krvi (kalcij, kalij, natrij),

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 Blocar Plus ako se išta od gore navedenog odnosi na Vas. Ako niste sigurni,

razgovarajte s Vašim liječnikom prije uzimanja Blocar Plus-a.

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Blocar Plus:

ako imate problema sa srcem, jetrom ili bubrezima,

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

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

dijalize),

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

ako trebate primiti anestetik zbog operativnog zahvata ili zahvata na zubima. U tom slučaju

će možda biti potrebno prekinuti liječenje Blocar Plus-om jedan dan prije zahvata. Upitajte

liječnika za savjet.

ako imate povišenu razinu kalija u krvi (vidljivu u rezultatima krvnih pretraga),

ako uzimate lijekove ili imate stanja koja mogu smanjiti razinu natrija u krvi. Vaš liječnik će,

vjerojatno, provoditi redovite krvne pretrage, osobito za provjeru razinu natrija u krvi,

pogotovo ako ste starije dobi.

ako imate vaskularnu bolest vezivnog tkiva, kao što je skleroderma ili sistemski eritematozni

lupus,

ako ste trudni ili mislite da biste mogli zatrudnjeti. Blocar Plus se ne preporuča u prva tri

mjeseca trudnoće i može ozbiljno naštetiti Vašem djetetu ako se koristi nakon trećeg mjeseca

trudnoće (vidjeti dio „Trudnoća i dojenje“).

ako Vaš vid slabi ili osjećate bol u očima, osobito ako ste pod povećanim rizikom

obolijevanja od glaukoma (povišenog očnog tlaka) ili ste alergični na lijekove koji sadrže

penicilin ili sulfonamide,

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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 takoĎer informacije pod naslovom “Nemojte uzimati Blocar Plus”.

Djeca i adolescenti

Blocar Plus se ne preporučuju djeci i adolescentima mlaĎim od 18 godina, jer nema dovoljno

podataka o primjeni lijeka u ovoj populaciji.

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

liječnikom prije uzimanja Blocar Plus-a.

Drugi lijekovi i Blocar Plus

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

koje druge lijekove. To uključuje i one koje ste kupili bez recepta (uključujući i biljne lijekove).

Razlog je u tome što Blocar Plus može utjecati na djelovanje drugih lijekova, a i drugi lijekovi

mogu utjecati na djelovanje Blocar Plus-a.

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

Blocar Plus-a:

lijekovi za ublažavanje boli i upale (nesteroidni protuupalni lijekovi (NSAIL), kao što su

acetilsalicilatna kiselina, ibuprofen ili indometacin),

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

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

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

vjerojatnost razvoja nuspojava ako ih uzimate s Blocar Plus-om:

lijekovi za ublažavanje boli i upale (nesteroidni protuupalni lijekovi (NSAIL), kao što su

acetilsalicilatna kiselina, ibuprofen ili indometacin),

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

diuretike (tablete za mokrenje), amfotericin B (za gljivične infekcije) i ACTH (za provjeru

aktivnosti adrenalnih žlijezda),

lijekovi za liječenje raka (kemoterapeutici),

lijekovi za srčane bolesti, uključujući probleme s brojem otkucaja srca,

imunosupresivi (lijekovi koji suzbijaju odbacivanje organa nakon transplantacije), kao što je

ciklosporin,

diuretici (lijekovi za mokrenje), kao što je furosemid,

lijekovi koji mogu povisiti razinu kalija u krvi, kao što su spironolakton, triamteren, amilorid,

kalijeve soli

heparin (lijek za razrjeĎivanje krvi),

steroidni lijekovi za liječenje upale, kao što je prednizolon,

nadomjesci kalcija,

alopurinol (za liječenje gihta),

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prokainamid (za liječenje problema sa srčanim ritmom),

kolestiramin (za smanjenje masnoća u krvi),

karbamazepin (za epilepsiju)

trimetoprim i kotrimoksazol (za infekcije uzrokovane bakterijama)

temsirolimus (za liječenje raka)

everolimus (za prevenciju odbacivanja presatka)

vildagliptin (koristi se u liječenju šećerne bolesti tipa 2)

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

ako uzimate neki blokator angiotenzin II receptora (ARB) ili aliskiren (vidjeti takoĎer

informacije pod naslovima “Nemojte uzimati Blocar Plus” i “Upozorenja i mjere opreza”).

Obavijestite liječnika ako uzimate bilo koji od sljedećih lijekova, jer Blocar Plus može utjecati

na njihov učinak:

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

glukoze u krvi i inzulin. Blocar Plus može dovesti do smanjenja koncentracije šećera u krvi,

pa je potrebno redovito provjeravati razinu šećera u krvi za vrijeme liječenja Blocar Plus

tabletama.

litij (za liječenje mentalnih bolesti). Blocar Plus može povisiti koncentraciju litija u krvi, pa je

potrebno pažljivo praćenje koncentracije litija od strane Vašeg liječnika.

lijekovi za opuštanje mišića,

kinin (za malariju),

lijekovi koji sadržavaju jod, a koriste se prilikom rendgenskog ili CT pregleda u bolnici,

penicilin (za infekcije),

lijekovi za razrjeĎivanje krvi koji se uzimaju kroz usta (oralni antikoagulansi), kao što je

varfarin.

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

liječnikom prije uzimanja Blocar Plus-a.

Pretrage

Posavjetujte se s Vašim liječnikom ili ljekarnikom prije uzimanja lijeka:

ako trebate obaviti ispitivanje funkcije paratireoidne žlijezde jer Blocar Plus može

utjecati na rezultate pretrage,

ako ste sportaš i trebate obaviti anti-doping kontrolu jer Blocar Plus može dati pozitivan

rezultat na testu.

Blocar Plus s hranom i pićem

Uzimanje alkohola s Blocar Plus tabletama može izazvati omaglicu ili ošamućenost. Ako

ne znate koliko alkohola smijete popiti dok uzimate Blocar Plus, razgovarajte s Vašim

liječnikom, s obzirom da lijekovi za snižavanje krvnog tlaka i alkohol mogu pojačati

osjećaj omaglice i ošamućenosti.

Blocar Plus se može uzeti s ili bez hrane.

Trudnoća, dojenje i plodnost

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

Vašem liječniku za savjet prije nego uzmete ovaj lijek.

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Ne preporuča se uzimanje Blocar plus tableta tijekom prvih 12 tjedana trudnoće, a ne smijete ih

uzimati nakon 13-og tjedna, s obzirom da njihovo uzimanje za vrijeme trudnoće može biti štetno

za dijete.

Ako zatrudnite za vrijeme uzimanja Blocar Plus-a, odmah obavijestite svog liječnika. Ako

planirate trudnoću, savjetujte se s liječnikom radi prelaska na primjerenu alternativnu terapiju.

Ne smijete koristiti Blocar Plus ako dojite.

Upitajte svog liječnika ili ljekarnika za savjet prije uzimanja bilo kojeg lijeka.

Upravljanje vozilima i strojevima

Za vrijeme uzimanja Blocar Plus tableta možete osjetiti omaglicu. Veća je vjerojatnost da se to

dogodi na početku liječenja i pri povećanju doze lijeka. Ako se to dogodi, nemojte upravljati

vozilima ili koristiti alate i strojeve.

Blocar Plus sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja

ovog lijeka.

3. Kako uzimati Blocar Plus?

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

liječnikom ili ljekarnikom ako niste sigurni.

Uzimanje lijeka

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

Tablete progutajte s tekućinom.

Nemojte drobiti ili žvakati tablete.

Koliko lijeka uzeti

Liječenje povišenog krvnog tlaka

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

Stariji bolesnici

Liječnik će smanjiti početnu dozu te će postupno prilagoĎavati Vašu terapiju.

Ako uzmete više Blocar Plus-a nego što ste trebali

Obavijestite liječnika ili otiĎite 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 Blocar Plus

Ako zaboravite uzeti lijek, uzmite sljedeću dozu prema rasporedu uzimanja.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

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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.

Prestanite uzimati Blocar Plus i odmah se obratite liječniku ako primijetite bilo koju od

sljedećih ozbiljnih nuspojava – možda će Vam biti potrebna i hitna medicinska pomoć:

oticanje lica, usana ili grla koje otežava gutanje ili disanje te svrbež i osip na koži – to mogu

biti znakovi ozbiljne alergijske reakcije na Blocar Plus,

ozbiljne kožne reakcije, uključujući osip na koži, čireve u ustima, pogoršanje postojećih

kožnih bolesti, crvenilo, mjehuriće na koži ili ljuštenje kože (kao što je Stevens-Johnson

sindrom, toksična epidermalna nekroliza ili multiformni eritem).

Odmah obavijestite liječnika ako primijetite nešto od sljedećeg:

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

prsima ili ozbiljnije probleme, kao što su srčani i moždani udar,

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

znaci problema s plućima, uključujući upalu.

češće javljanje modrica, krvarenje dulje nego što je normalno, bilo kakve znakove

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

uobičajeno, ako imate bolno grlo i vrućicu, osjećaj umora, nesvjesticu, omaglicu ili

blijedu kožu. To mogu biti znaci problema s krvlju ili koštanom srži.

jake bolove u želucu, koji se mogu proširiti na leĎa. To može biti znak upale gušterače.

vrućicu, zimicu, umor, gubitak apetita, bol u želucu, mučninu, žutilo kože ili očiju

(žutica). To mogu biti znaci problema s jetrom, kao što je hepatitis (upala jetre) ili

oštećenje jetre.

Ostale nuspojave:

Molimo Vas da obavijestite liječnika ako neke od sljedećih nuspojava postanu ozbiljne ili

traju duže od nekoliko dana.

Često (javljaju se u manje od 1 na 10 bolesnika)

glavobolja, opća slabost ili umor,

omaglica (češće se javlja na početku liječenja i pri povećanju doze lijeka),

suhi nadražujući kašalj ili bronhitis,

krvni nalazi koji ukazuju na povećanu razinu šećera u krvi (ako bolujete od šećerne

bolesti to ju može pogoršati),

krvni nalazi koji ukazuju na povećanu razinu mokraćne kiseline ili masti u krvi,

bolni, crveni ili natečeni zglobovi.

Manje često (javljaju se u manje od 1 na 100 bolesnika)

osip na koži, s ili bez ispupčenja dijelova kože,

crvenilo praćeno vrućinom, nesvjestica, hipotenzija (smanjenje krvnog tlaka), posebice

pri naglom ustajanju ili sjedanju,

problemi s ravnotežom (vrtoglavica),

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svrbež i neobični osjeti na koži (trnjenje, peckanje, bockanje, pečenje ili osjećaj puzanja

po koži),

gubitak ili poremećaj okusa,

poteškoće sa spavanjem,

osjećaj depresije, napetosti, povećane nervoze ili nemira,

začepljen nos, upala sinusa (sinusitis), otežano disanje

upala desni (gingivitis), natečena usta,

crvene, nadražene, natečene ili suzne oči,

zujanje u ušima,

zamućen vid,

gubitak kose,

bolovi u prsištu,

bol u mišićima,

zatvor, bol u želucu ili crijevima,

poremećaji probave ili mučnina,

povećano izlučivanje urina tijekom dana (mokrenje),

znojenje jače od uobičajenog ili osjećaj žeĎi,

gubitak ili smanjenje apetita (anoreksija), smanjen osjećaj gladi,

ubrzani ili nepravilni otkucaji srca,

oticanje ruku i nogu - ovo mogu biti znakovi pojačanog zadržavanja tekućine u tijelu,

vrućica,

prolazna seksualna nemogućnost (impotencija) u muškaraca,

krvni nalazi koji ukazuju na smanjenje broja crvenih ili bijelih krvnih stanica, krvnih

pločica (trombocita) ili koncentracije hemoglobina u krvi,

krvni nalazi koji ukazuju na promjene u radu jetre, gušterače ili bubrega,

krvni nalazi koji ukazuju na smanjenu razina kalija u krvi.

Vrlo rijetko (javljaju se u manje od 1 na 10 000 bolesnika)

povraćanje, bol u trbuhu, proljev ili žgaravica,

suha usta ili crven i natečen jezik,

krvni nalazi koji ukazuju na povećanu razina kalija u krvi.

Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)

koncentrirani urin (tamne boje), mučnina ili povraćanje, grčevi u mišićima, smetenost i

napadaji koji mogu biti posljedica neodgovarajućeg izlučivanja ADH-a (antidiuretskog

hormona). Ako imate te simptome, obratite se svom liječniku što je prije moguće.

Ostale prijavljene nuspojave

Molimo Vas da obavijestite liječnika ako neke od sljedećih nuspojava postanu ozbiljne ili traju

duže od nekoliko dana:

teškoće u koncentraciji, nemir ili zbunjenost,

prsti na rukama i nogama mijenjaju boju kad Vam je hladno uz osjećaj trnjenja ili boli

kad se ugrijete (Raynaudov fenomen),

povećanje grudi u muškaraca,

krvni ugrušci,

poremećaj sluha,

smanjeno suzenje očiju,

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poremećaj vida (žuti doživljaj boje),

dehidracija,

oticanje, bol ili crvenilo u obrazima (upala žlijezde slinovnice),

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

povraćanje i proljev,

povećana osjetljivost na sunce,

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

kao što je osip praćen crvenilom na licu i čelu,

kožni osip ili modrice,

mrlje na koži ili hladnoća u ekstremitetima,

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

mišićno-koštana ukočenost ili nemogućnost pomicanja čeljusti (tetanija),

slabost ili grčevi u mišićima,

smanjena seksualna želja u muškaraca i žena,

krv u mokraći (to može biti znak problema s bubrezima - intersticijski nefritis),

povećana razina šećera u mokraći,

nalazi krvnih pretraga koji ukazuju na povećanje broja jedne vrste bijelih krvnih stanica

(eozinofilija),

nalazi krvnih pretraga koji ukazuju na smanjenje ukupnog broja svih krvnih stanica

(pancitopenija),

nalazi krvnih pretraga koji ukazuju na promjene razine soli (kao što su natrij, kalcij,

magnezij i klorid) u krvi,

usporena ili narušena sposobnost reakcije,

poremećaj njuha,

otežano disanje ili pogoršanje astme,

jaka bol u oku, zamućen vid ili uočavanje aureole (prstena) oko svjetla, glavobolja,

obilno suzenje oka ili mučnina i povraćanje. To mogu biti znaci stanja koje se zove

glaukom (povišen očni tlak).

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 Blocar Plus?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 25ºC, u originalnom pakiranju, zaštićeno od vlage.

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

EXP.

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.

H A L M E D

10 - 11 - 2017

O D O B R E N O

6. Sadržaj pakiranja i druge informacije

Što Blocar Plus sadrži?

Djelatne tvari su: ramipril i hidroklorotiazid.

1 tableta Blocar Plus 2,5 mg + 12,5 mg sadrži: 2,5 mg ramiprila i 12,5 mg hidroklorotiazida.

1 tableta Blocar Plus 5 mg + 25 mg sadrži 5 mg ramiprila i 25 mg hidroklorotiazida.

Pomoćne tvari su: laktoza hidrat; hipromeloza; krospovidon; celuloza, mikrokristalična; natrijev

stearilfumarat.

Kako Blocar Plus tablete izgledaju i sadržaj pakiranja?

Blocar Plus 2,5 mg + 12,5 mg: bijele tablete u obliku kapsula, s razdjelnom crtom s obje strane,

na jednoj strani su utisnute oznake „2.5“ i „12.5“.

Blocar Plus 5 mg + 25 mg: bijele tablete u obliku kapsula, s razdjelnom crtom s obje strane, na

jednoj strani su utisnute oznake „5“ i „25“.

28 tableta (2x14) tableta u PVC/PCTFE/Al blisteru, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

JADRAN- GALENSKI LABORATORIJ d.d., Svilno 20, 51000 Rijeka, Hrvatska

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u studenom 2017.

H A L M E D

10 - 11 - 2017

O D O B R E N O

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

12-10-2018

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

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia