Bupain 15 mikrograma h

Glavna informacija

  • Trgovački naziv:
  • Bupain 15 mikrograma/h transdermalni flaster
  • Doziranje:
  • 15 mikrograma/h
  • Farmaceutski oblik:
  • transdermalni flaster
  • Sastav:
  • Urbroj: svaki transdermalni flaster sadrži 15 mg buprenorfina na 18,75 cm2, otpuštajući 15 mikrograma buprenorfina na sat
  • Tip recepta:
  • na recept, u ljekarni poseban recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Hexal AG, Holzkirchen, Njemačka

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Bupain 15 mikrograma/h transdermalni flaster
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 1 transdermalni flaster u zaštitnoj vrećici, u kutiji [HR-H-819807574-01]; 2 transdermalna flastera pojedinačno pakirana u zaštitnoj vrećici, u kutiji [HR-H-819807574-02]; 3 transdermalna flastera pojedinačno pakirana u zaštitnoj vrećici, u kutiji [HR-H-819807574-03]; 4 transdermalna flastera pojedinačno pakirana u zaštitnoj vrećici, u kutiji [HR-H-819807574-04]; 5 transdermalnih flastera pojedinačno pakiranih u zaštitnoj vrećici, u kutiji [HR-H-819807574-05]; 8 transdermalnih flastera pojedinačno pakiranih u zaštitnoj vrećici, u kutiji [HR-H-819807574-06]; 10 transdermalnih flastera pojedinačno pakiranih u zaštitnoj vrećici, u kutiji [HR-H-819807574-07]; 12 transdermalnih flastera pojedinačno pakiranih u zaštitnoj vrećici, u kutiji [HR-H-819807574-08]; 20 transdermalnih flastera pojedinačno pakiranih u zaštitnoj vrećici, u kutiji [HR-H-819807574-09] Urbroj: 381-12-01/30-16-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-819807574
  • Datum autorizacije:
  • 31-03-2016
  • Zadnje ažuriranje:
  • 04-06-2018

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

Uputa o lijeku: Informacije za korisnika

Bupain 5 mikrograma/h transdermalni flaster

Bupain 10 mikrograma/h transdermalni flaster

Bupain 15 mikrograma/h transdermalni flaster

Bupain 20 mikrograma/h transdermalni flaster

buprenorfin

Za primjenu u odraslih

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

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

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

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti 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 Bupain transdermalni flaster i za što se koristi

Što morate znati prije nego počnete primjenjivati Bupain transdermalni flaster

Kako primjenjivati Bupain transdermalni flaster

Moguće nuspojave

Kako čuvati Bupain transdermalni flaster

Sadržaj pakiranja i druge informacije

1.

Što je Bupain transdermalni flaster

i za što se koristi

Bupain transdermalni flaster sadrži djelatnu tvar buprenorfin koji pripada skupini lijekova jakih

analgetika odnosno lijekova protiv boli.

Bupain transdermalni flaster je namijenjen odraslima za ublažavanje umjerene, dugotrajne boli koja

zahtjeva korištenje jakih lijekova protiv boli.

Bupain transdermalni flaster nije namijenjen za ublažavanje akutne boli.

2.

Što morate znati prije nego počnete primjenjivati Bupain transdermalni flaster?

Nemojte uzimati Bupain transdermalni flaster:

ako ste alergični

na buprenorfin ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6)

ako imate problema s disanjem

ako ste ovisnik o drogama

ako uzimate inhibitore monoaminoksidaze (MAO inhibitore) kao npr. tranilcipromin, fenelzin,

izokarboksazid, moklobemid i linezolid, ili ako ste u zadnja dva tjedna uzeli tu vrstu lijeka

ako bolujete od bolesti miastenia gravis (stanje u kojem mišići postaju slabi)

ako ste prethodno patili od simptoma uzrokovanih prekidom uzimanja alkohola, kao što su

uznemirenost, tjeskoba, tresavica ili znojenje

Bupain transdermalni flaster se ne smije koristiti za liječenje simptoma povezanih s ustezanjem.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego primijenite Bupain transdermalni flaster:

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ako ste nedavno pili velike količine alkohola

ako bolujete od napadaja ili konvulzija

imate jaku glavobolju ili mučninu zbog ozljede glave ili povećanog pritiska u lubanji (primjerice

zbog bolesti mozga). To je zato što buprenorfin može pogoršati simptome ili zamaskirati

opsežnost ozljede glave.

ako osjećate ošamućenost ili nesvjesticu

ako imate teških problema s jetrom

ako ste ikada bili ovisnik o drogama ili alkoholu

ako imate visoku temperaturu jer takvo stanje može povećati apsorpciju djelatne tvari u krvi

ako ste sportaš: ovaj lijek može uzrokovati pozitivne rezultate doping kontrole

Ako ste nedavno bili na operaciji, razgovarajte sa svojim liječnikom prije primjene ovih

transdermalnih flastera.

Djeca i adolescenti

Bupain transdermalni flaster se ne smije koristiti u bolesnika mlađih od 18 godina.

Drugi lijekovi i Bupain transdermalni flaster

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

druge lijekove.

Bupain transdermalni flaster se ne smije koristiti zajedno s inhibitorima monoaminooksidaze

(MAO inhibitori), kao npr. tranilcipromin, fenelzin, izokarboksazid, moklobemid i linezolid), ili

ako ste u zadnja dva tjedna uzeli tu vrstu lijeka.

Ako uzimate neke lijekove, kao što su fenobarbital ili fenitoin (lijekovi koji se najčešće koriste za

liječenja napadaja ili konvulzija), karbamazepin (lijek za liječenje napadaja ili konvulzija i

određenih bolnih stanja) ili rifampicin (lijek za liječenje tuberkuloze), učinci Bupain

transdermalnog flastera mogu se smanjiti.

Bupain transdermalni flaster može kod nekih ljudi izazvati osjećaj omamljenosti, mučnine ili

nesvjestice ili im usporiti i oslabiti disanje. Ove nuspojave mogu se pogoršati ako se istovremeno

primjenjuju drugi lijekovi s istim učincima. To uključuje određene lijekove za liječenje boli,

depresije, tjeskobe, psihijatrijske ili mentalne poremećaje, lijekove za spavanje, lijekove za

liječenje visokog krvnog tlaka kao što je klonidin, druge opioide (koji se mogu naći u lijekovima

protiv bolova ili određenim kombiniranim preparatima protiv kašlja npr. morfin,

dekstropropoksifen, kodein, dekstrometorfan, noskapin), antihistaminike koji Vas mogu omamiti

ili anestetike poput halotana.

Bupain transdermalni flaster se mora koristiti s oprezom ukoliko uzimate benzodiazepine (lijekovi

koji se koriste za liječenje tjeskobe ili za spavanje). Ova kombinacija može uzrokovati ozbiljne

probleme s disanjem, što može biti smrtonosno u slučaju predoziranja. Obavijestite svog liječnika

ako uzimate ovu kombinaciju.

Bupain transdermalni flaster s alkoholom

Alkohol može pogoršati neke nuspojave, a Vi se možete osjećati loše ako pijete alkohol dok koristite

Bupain transdermalni flaster. Konzumiranje alkohola tijekom korištenja Bupain transdermalnog

flastera također može utjecati na Vaše vrijeme reagiranja.

Trudnoća i dojenje

Ako ste trudni ili dojite, mislite da ste trudni ili planirate imati dijete, upitajte svog liječnika ili

ljekarnika za savjet prije uzimanja ovog lijeka.

Ne smijete koristiti Bupain transdermalni flaster ako ste trudni, ako postoji vjerojatnost da ostanete

trudni ili ako dojite.

Upravljanje vozilima i strojevima

Bupain transdermalni flaster može utjecati na Vaše reakcije u tolikoj mjeri da ne reagirate na

odgovarajući način ili dovoljno brzo u slučaju neočekivanih i naglih pojava. To je posebno izraženo:

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na početku liječenja

ako uzimate lijekove za liječenje tjeskobe ili za spavanje

ako Vam je doza povećana

Ako lijek tako djeluje na Vas (npr. osjećate omaglicu, omamljenost ili imate zamagljen vid) ne smijete

voziti ili upravljati strojevima za vrijeme primjene Bupain transdermalnog flastera ili tijekom 24 sata

nakon uklanjanja transdermalnog flastera.

3.

Kako primjenjivati Bupain transdermalni flaster

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

Vašim liječnikom ili ljekarnikom ako niste sigurni.

Dostupne su različite jačine Bupain transdermalnog flastera. Vaš liječnik će odlučiti koja jačina

Bupain transdermalnog flastera će Vam najbolje odgovarati.

Tijekom liječenja Vaš liječnik može, ako je potrebno, promijeniti transdermalni flaster koji koristite na

manji ili veći, ili Vam reći da koristite kombinaciju od najviše dva flastera.

Ne smijete primijeniti

više od dva transdermalna flastera istovremeno, pri čemu maksimalna ukupna doza iznosi do 40

mikrograma/sat.

Ako smatrate da je učinak Bupain transdermalnog flastera preslab ili prejak, posavjetujte se s

liječnikom ili ljekarnikom.

Odrasli

Osim ako Vam je Vaš liječnik rekao drugačije, zalijepite jedan Bupain transdermalni flaster (kao što

je detaljno opisano u nastavku) i promijenite ga svaki sedmi dan, po mogućnosti u isto doba dana. Vaš

liječnik može prilagoditi dozu nakon 3-7 dana, dok se ne ustanovi točna doza za kontrolu boli. Ako

Vam je liječnik savjetovao uzimanje drugih lijekova protiv boli, dodatno uz transdermalni

flaster, strogo slijedite upute liječnika, inače nećete u potpunosti imati koristi od

liječenja buprenorfin flasterom. Transdermalni flaster treba nositi tijekom 3 puna dana prije povećanja

doze, jer se tada postiže maksimalan učinak primijenjene doze.

B

olesnici s bolešću jetre

U bolesnika s bolešću jetre, učinci i razdoblje djelovanja buprenorfin transdermalnog flastera mogu

biti poremećeni, stoga će Vas Vaš liječnik pažljivije pratiti.

Primjena u djece i adolescenata

Bupain transdermalni flaster se ne smije koristiti u bolesnika ispod 18 godina starosti.

Način primjene

Bupain transdermalni flaster omogućuje primjenu lijeka kroz kožu.

To znači da transdermalni flasteri djeluju kroz kožu. Nakon primjene flastera, buprenorfin prolazi kroz

kožu u krv.

Prije primjene

Bupain transdermalnog flastera

Odaberite područje nenadražene, neoštećene kože na vanjskoj strani nadlaktice , gornjem

dijelu prsišta, gornjem dijelu leđa ili sa strane prsnog koša (vidjeti ilustracije). Pitajte

za pomoć ako ne možete sami zalijepiti transdermalni flaster.

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Bupain transdermalni flaster treba primijeniti na područje koje je relativno bez dlaka ili gotovo bez

dlake. Ako nemate takvih područja, dlake treba odrezati škarama. Nemojte ih brijati.

Izbjegavajte kožu koja je crvena, nadražena ili ima neke druge nedostatke, primjerice velike

ožiljke.

Područje kože koje odaberete mora biti suho i čisto. Ako je potrebno operite ga hladnom ili

mlakom vodom. Nemojte koristiti sapun, alkohol, ulje, losione ili druge deterdžente. Nakon

kupanja u vrućoj kupki ili tuširanja, pričekajte da se Vaša koža potpuno osuši i ohladi. Nemojte

nanositi losion, kremu ili mast na odabranom području. To može otežati pravilno prianjanje Vašeg

transdermalnog flastera.

Primjena transdermalnog flastera

Korak 1: svaki transdermalni flaster je zatvoren u vrećicu. Neposredno prije upotrebe, otvorite vrećicu

povlačenjem gdje je naznačeno. Izvadite transdermalni flaster. Nemojte koristiti

transdermalni flaster ako je vrećica otvorena.

Korak 2: ljepljiva strana transdermalnog flastera je prekrivena prozirnom folijom. Pažljivo odlijepite

pola folije. Pokušajte ne dirati ljepljivi dio transdermalnog flastera.

Korak 3: zalijepite transdermalni flaster na područje kože koje ste odabrali i uklonite preostalu foliju.

Korak 4: dlanom pritisnite transdermalni flaster na kožu i polako brojite do 30. Uvjerite se da je cijeli

transdermalni flaster u kontaktu s kožom, osobito na rubovima.

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Nošenje transdermalnog flastera

Trebali biste nositi transdermalni flaster tijekom sedam dana. Pod uvjetom da ste ispravno primijenili

transdermalni flaster, mala je opasnost da će se odlijepiti. Ako se rubovi transdermalnog flastera počnu

odljepljivati, mogu se pričvrstiti odgovarajućom trakom za kožu. Možete se tuširati, kupati ili plivati

dok ga nosite.

Ne izlažite transdermalni flaster prekomjernoj vrućini (npr. grijani jastučići, električne deke, lampe za

grijanje, sauna, tople kupke, grijani vodeni kreveti, termofor, itd.), jer to može dovesti do prelaska

povećane količine djelatne tvari iz flastera u krv. Vanjska toplina također može spriječiti ispravno

prianjanje transdermalnog flastera. Ako imate povišenu temperaturu to može promijeniti učinke

Bupain transdermalnog flastera (vidjeti prethodni dio „Upozorenja i mjere opreza“).

U malo vjerojatnom slučaju da Vaš transdermalni flaster otpadne prije nego što ga trebate zamijeniti,

nemojte ponovo koristiti isti flaster. Odmah prilijepite novi flaster (vidjeti „Zamjena transdermalnog

flastera“ u nastavku).

Zamjena transdermalnog flastera

Skinite stari transdermalni flaster.

Presavijte ga napola tako da ljepljivi dio bude s unutarnje strane.

Otvorite i izvadite novi transdermalni flaster. Iskoristite praznu vrećicu da u nju odložite stari

transdermalni flaster. Sada bacite vrećicu na sigurno.

Novi transdermalni flaster prilijepite na neko drugo, prikladno mjesto na koži (kao što je gore

opisano). Ne smijete prilijepiti novi transdermalni flaster na isto mjesto na koži tijekom najmanje

3-4 tjedna.

Ne zaboravite promijeniti svoj transdermalni flaster u isto doba dana. Važno je da zabilježite doba

dana.

Trajanje liječenja

Vaš liječnik će Vam reći koliko dugo trebate primjenjivati Bupain transdermalni flaster. Nemojte

prekinuti liječenje bez savjetovanja s liječnikom, jer Vam se bol može vratiti, a možete se i osjećati

loše (vidjeti također „Ako prestanete primjenjivati Bupain transdermalni flaster“ u nastavku).

Ako primijenite više Bupain transdermalnih flastera nego što ste trebali

Čim primijetite da ste primijenili više transdermalnih flastera nego što ste trebali, uklonite sve

transdermalne flastere i odmah zatražite savjet svog liječnika ili najbliže bolnice. Osobe koje su uzele

preveliku dozu mogu se osjećati izrazito pospano i bolesno. Također, mogu imati poteškoća s disanjem

ili izgubiti svijest i može im biti potrebno hitno liječenje u bolnici. Kada tražite liječničku pomoć

pobrinite se da ovu uputu uzmete sa sobom, kao i preostale transdermalne flastere kako biste ih

pokazali liječniku.

Ako ste zaboravili primijeniti Bupain transdermalni flaster

Primijenite novi transdermalni flaster čim se sjetite. Također, zabilježite datum, jer se Vaš uobičajeni

dan za promjenu flastera sada može promijeniti. Ako izrazito kasnite s promjenom transdermalnog

flastera, bol se može vratiti. U tom slučaju, obratite se svom liječniku.

Nemojte primjenjivati dodatne transdermalne flastere kako biste nadoknadili one koje ste zaboravili

primijeniti.

Ako prestanete primjenjivati Bupain transdermalni flaster

Ako prestanete primjenjivati Bupain transdermalni flaster prerano ili ako prekinete liječenje, bol se

može vratiti. Ako želite prekinuti liječenje, obratite se liječniku. Liječnik će Vam reći što se može

učiniti i možete li se liječiti drugim lijekovima.

Pojedine osobe mogu imati nuspojave ako su dugo vremena koristile jake lijekove protiv bolova i

zatim ih prestale uzimati. Rizik od učinaka nakon prekida primjene Bupain transdermalnog flastera je

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vrlo nizak. Međutim, ako osjećate uznemirenost, tjeskobu, razdražljivost ili imate drhtanje, ako ste

preaktivni, imate poteškoća sa spavanjem ili probavne smetnje, obavijestite svog liječnika.

Djelovanje Bupain transdermalnog flastera na ublažavanje boli održava se još određeno vrijeme nakon

uklanjanja transdermalnog flastera. Ne smijete započeti s primjenom drugog opioidnog analgetika (jaki

lijek protiv bolova) unutar 24 sata nakon uklanjanja transdermalnog flastera.

U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku

ili ljekarniku.

4.

Moguće nuspojave

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

Ozbiljne nuspojave koje mogu biti povezane s Bupain transdermalnim flasterom su slične onima koje

su opažene kod drugih jakih lijekova protiv bolova i uključuju otežano disanje te sniženje krvnog

tlaka.

Ovaj lijek može izazvati alergijske reakcije, iako su ozbiljne alergijske reakcije rijetke. Odmah

uklonite transdermalni flaster i obavijestite svog liječnika ako ste primijetili nagli nastup piskanja pri

disanju, otežano disanje, oticanje vjeđa, lica ili usana, osip ili svrbež osobito ako se jave na cijelom

tijelu.

Postoji rizik od navikavanja ili razvoja ovisnosti o Bupain transdermalnom flasteru.

U bolesnika liječenih Bupain transdermalnim flasterom, zabilježene su i sljedeće nuspojave:

Vrlo često

(mogu se javiti u više od 1 na 10 osoba)

glavobolja, omaglica, omamljenost

zatvor, suha usta, mučnina ili povraćanje

svrbež, crvenilo, svrbež na mjestu primjene

Često

(mogu se javiti u do 1 na 10 osoba)

gubitak apetita

smetenost, depresija, poteškoće sa spavanjem, razdražljivost

trnci ili obamrlost

crvenilo kože praćeno osjećajem vrućine

nedostatak zraka

bol ili nelagoda u trbuhu, proljev, poremećaj probave

znojenje, osip, promjene na koži

umor, osjećaj neobične slabosti, bol, bol u prsištu, oticanje šaka, gležnjeva ili stopala, crvenilo

ili osip na mjestu primjene

Manje često

(mogu se javiti u do 1 na 100 osoba)

dehidracija

promjene raspoloženja, nemir, agitacija, tjeskoba, osjećaj odvojenosti od samoga sebe, osjećaj

prekomjerne radosti, halucinacije, noćne more

promjene okusa, otežan govor, smanjena osjetljivost na bol ili dodir, gubitak pamćenja,

migrena, nesvjestica, drhtanje, poteškoće s koncentracijom ili koordinacijom

suhe oči, zamagljen vid

zvonjenje ili šum u ušima

osjećaj omaglice ili okretanja

povišeni ili sniženi krvni tlak, angina pektoris (jaka bol u prsištu povezana s bolešću srca),

ubrzani ili nepravilni otkucaji srca

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pogoršanje poteškoća s disanjem povezanih s astmom, kašalj, štucanje, ubrzano disanje,

smanjena razina kisika u krvi, iscjedak iz nosa, piskanje pri disanju

vjetrovi

gubitak težine

suha koža, oticanje lica

grčevi u mišićima, spazmi, bolovi i slabost

otežano započinjanje mokrenja

nemogućnost potpunog pražnjenja mjehura

bolest slična gripi, visoka temperatura, drhtanje (zimica), opće loše osjećanje

učestalije nehotične ozljede (npr. padovi)

simptomi ustezanja kao što su uznemirenost, tjeskoba, znojenje ili drhtanje nakon prestanka

primjene Bupain transdermalnog flastera

osjećaj nesvjestice, osobito prilikom ustajanja

Ako trebate obaviti pretrage krvi, podsjetite svog liječnika da koristite Bupain transdermalni flaster.

To je važno jer Bupain transdermalni flaster može promijeniti način na koji radi Vaša jetra, a to bi

moglo utjecati na rezultate nekih krvnih pretraga.

Rijetko

(mogu se javiti u do 1 na 1000 osoba)

smanjen seksualni nagon, mentalni poremećaj

poteškoće s ravnotežom

oticanje kapaka ili lica, suženje zjenica oka

otežano disanje

divertikulitis (upala crijeva), otežano gutanje

lokalna alergijska reakcija s izraženim znakovima oticanja (u takvim slučajevima liječenje treba

prekinuti)

smanjena erekcija, seksualna disfunkcija

bol u trbuhu u obliku grčeva ili nelagoda

Vrlo rijetko

(mogu se javiti u do 1 na 10000 osoba)

trzanje mišića

bol u uhu

mjehuri

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. Ovo 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 Bupain transdermalni flaster

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici iza „Rok

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

Ne čuvati na temperaturi iznad 25 °C.

Transdermalni flaster se ne smije upotrijebiti ako primijetite da je vrećica već otvorena.

Upotrijebljeni transdermalni flaster mora se presavinuti s ljepljivom stranom prema unutra i sigurno

baciti.

H A L M E D

29-09-2016

O D O B R E N O

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

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

6.

Sadržaj pakiranja i druge informacije

Što Bupain transdermalni flaster sadrži

Djelatna tvar je buprenorfin.

Bupain 5 mikrograma/h transdermalni flaster:

Svaki transdermalni flaster sadrži 5 mg buprenorfina na 6,25 cm

, otpuštajući 5 mikrograma

buprenorfina na sat.

Bupain 10 mikrograma/h transdermalni flaster:

Svaki transdermalni flaster sadrži 10 mg buprenorfina na 12,5 cm

, otpuštajući 10 mikrograma

buprenorfina na sat.

Bupain 15 mikrograma/h transdermalni flaster:

Svaki transdermalni flaster sadrži 15 mg buprenorfina na 18,75 cm

, otpuštajući 15 mikrograma

buprenorfina na sat.

Bupain 20 mikrograma/h transdermalni flaster:

Svaki transdermalni flaster sadrži 20 mg buprenorfina na 25 cm

, otpuštajući 20 mikrograma

buprenorfina na sat.

Drugi sastojci su:

Zaštitna folija

(koja se uklanja prije primjene flastera): silikonizirana poli(etilen tereftalat) folija

Ljepiva matrica (sadrži buprenorfin): levulinska kiselina, oleil oleat, povidon K 90, poli[akrilna

kiselina-ko-butilakrilat-ko-(2-etilheksil)akrilat-ko-vinilacetat] (5:15:75:5)

Razdjelna folija (između ljepivih matrica s i bez buprenorfina: poli(etilen tereftalat) folija

Samoljepiva matrica (bez buprenorfina): akrilatni adheziv

Potporni sloj (otisnut): poliuretanska potporna folija, tinta za označavanje.

Kako Bupain transdermalni flaster izgleda i sadržaj pakiranja

Bupain transdermalni flaster je blijedo žućkasto-smeđi, pravokutni transdermalni flaster s zaobljenim

rubovima, na kojem je otisnuto sljedeće:

Buprenorphinum 5 µg/h

Buprenorphinum 10 µg/h

Buprenorphinum 15 µg/h

Buprenorphinum 20 µg/h

Svaki transdermalni flaster je zasebno pakiran u sigurnosnu vrećicu koju djeca ne mogu otvoriti.

Kutija sadrži 1, 2, 3, 4, 5, 8, 10, 12 ili 20 transdermalna flastera.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja za stavljanje lijeka u promet

Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska

H A L M E D

29-09-2016

O D O B R E N O

Proizvođač

Hexal AG, Industriestrasse 25, D-83607 Holzkirchen, Njemačka

Ovaj lijek je odobren u državama članicama Europskog gospodarskog prostora (EGP) pod

sljedećim nazivima:

Njemačka

Bupre-HEXAL 7 Tage 5 Mikrogramm/Stunde transdermales Pflaster

Bupre-HEXAL 7 Tage 10 Mikrogramm/Stunde transdermales Pflaster

Bupre-HEXAL 7 Tage 15 Mikrogramm/Stunde transdermales Pflaster

Bupre-HEXAL 7 Tage 20 Mikrogramm/Stunde transdermales Pflaster

Austrija

Bupacal 5 Mikrogramm/h - transdermales Pflaster

Bupacal 10 Mikrogramm/h - transdermales Pflaster

Bupacal 15 Mikrogramm/h - transdermales Pflaster

Bupacal 20 Mikrogramm/h - transdermales Pflaster

Belgija

Buprenorfine Sandoz Wekelijks 5 microgram/uur pleister voor transdermaal

gebruik

Buprenorfine Sandoz Wekelijks 10 microgram/uur pleister voor transdermaal

gebruik

Buprenorfine Sandoz Wekelijks 15 microgram/uur pleister voor transdermaal

gebruik

Buprenorfine Sandoz Wekelijks 20 microgram/uur pleister voor transdermaal

gebruik

Češka Republika

Bupainx 5 mikrogramů/h

Bupainx 10 mikrogramů/h

Bupainx 15 mikrogramů/h

Bupainx 20 mikrogramů/h

Danska

Buprenorphine Sandoz

Španjolska

Buprenorfina Sandoz 5 microgramos/hora parche transdérmico

Buprenorfina Sandoz 20 microgramos/hora parche transdérmico

Finska

Buprenorphine Sandoz

Hrvatska

Bupain 5 mikrograma/h transdermalni flaster

Bupain 10 mikrograma/h transdermalni flaster

Bupain 15 mikrograma/h transdermalni flaster

Bupain 20 mikrograma/h transdermalni flaster

Irska

TRANSORPHINE 5 micrograms/hour Transdermal Patch

TRANSORPHINE 10 micrograms/hour Transdermal Patch

TRANSORPHINE 15 micrograms/hour Transdermal Patch

TRANSORPHINE 20 micrograms/hour Transdermal Patch

Luksemburg

Buprenorfin Sandoz 5 mcg /1 h dispositif transdermique

Buprenorfin Sandoz 10 mcg /1 h dispositif transdermique

Buprenorfin Sandoz 15 mcg /1 h dispositif transdermique

Buprenorfin Sandoz 20 mcg /1 h dispositif transdermique

Nizozemska

Buprenorfine Sandoz 5 microgram/uur, pleister voor transdermaal gebruik

Buprenorfine Sandoz 10 microgram/uur, pleister voor transdermaal gebruik

Buprenorfine Sandoz 15 microgram/uur, pleister voor transdermaal gebruik

Buprenorfine Sandoz 20 microgram/uur, pleister voor transdermaal gebruik

Norveška

Bugnanto

Poljska

Norvipren

Portugal

Buprenorfina Sandoz

Švedska

Buprenorphine Sandoz

Velika Britanija

Reletrans 5 microgram/h transdermal patch

Reletrans 10 microgram/h transdermal patch

Reletrans 15 microgram/h transdermal patch

Reletrans 20 microgram/h transdermal patch

H A L M E D

29-09-2016

O D O B R E N O

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u rujnu 2016.

H A L M E D

29-09-2016

O D O B R E N O

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

20-11-2018

Mariam, Floris en Mookie beëdigd tot kinderbewindspersonen van VWS

Mariam, Floris en Mookie beëdigd tot kinderbewindspersonen van VWS

Nederland is vandaag op de Internationale Dag van de Rechten van het Kind drie bewindspersonen rijker. Mariam Yousfi (13 jaar) en Floris Vooren (13 jaar) zijn door ministers Hugo de Jonge en Bruno Bruins benoemd tot kinderminister en Mookie Saluna (15 jaar) is door staatssecretaris Paul Blokhuis benoemd tot kinderstaatssecretaris. De kinderbewindspersonen zullen een jaar lang het ministerie van Volksgezondheid, Welzijn en Sport (VWS) met slimme tips en praktische adviezen helpen het beleid beter en kindv...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Enforcement Report for the Week of October 17, 2018

Enforcement Report for the Week of October 17, 2018

Recently Updated Records for the Week of October 17, 2018 Last Modified Date: Monday, October 15, 2018

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

FDA - U.S. Food and Drug Administration

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

16-8-2018

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

FDA - U.S. Food and Drug Administration

15-8-2018

Enforcement Report for the Week of August 15, 2018

Enforcement Report for the Week of August 15, 2018

Recently Updated Records for the Week of August 15, 2018 Last Modified Date: Monday, August 13, 2018

FDA - U.S. Food and Drug Administration

14-8-2018

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte neemt woensdagmiddag 15 augustus 2018 deel aan de herdenking van de capitulatie van Japan op 15 augustus 1945. De herdenking vindt plaats bij het Indisch Monument in Den Haag.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

18-7-2018

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Staatssecretaris Paul Blokhuis (VWS) wil het aantal zelfmoorden en zelfmoordpogingen terugdringen. Om dat te bereiken geeft hij structureel 2 miljoen per jaar extra instellingssubsidie aan 113Zelfmoordpreventie. Het jaarlijkse budget van de organisatie gaat daarmee fors omhoog, van 3,4 miljoen naar 5,4 miljoen euro. Daarnaast zijn er extra middelen voor andere lopende activiteiten zoals de lokale aanpakken suïcidepreventie en onderzoek. In totaal is daar 15 miljoen mee gemoeid.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

4-12-2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

A detailed walkthrough of the Code with examples to illustrate the application of the key sections.

Therapeutic Goods Administration - Australia

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

23-11-2018

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more:  https://go.usa.gov/xPHxf   #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

15-11-2018

alitretinoin

alitretinoin

alitretinoin (Active substance: alitretinoin) - Centralised - Art 28 - (PSUR - Commission Decision (2018)7675 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/90/201801

Europe -DG Health and Food Safety

15-11-2018

Benepali (Samsung Bioepis NL B.V.)

Benepali (Samsung Bioepis NL B.V.)

Benepali (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018) 7557 of Thu, 15 Nov 2018

Europe -DG Health and Food Safety

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

15-8-2018

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5042 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/284/14/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety

10-7-2018

Corbilta (Orion Corporation)

Corbilta (Orion Corporation)

Corbilta (Active substance: levodopa / carbidopa / entacapone) - Centralised - Renewal - Commission Decision (2018)4468 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2785/R/15

Europe -DG Health and Food Safety