EpiPen Jr 0 15 mg otopina

Glavna informacija

  • Trgovački naziv:
  • EpiPen Jr 0,15 mg otopina za injekciju
  • Doziranje:
  • 0,15 mg
  • Farmaceutski oblik:
  • otopina za injekciju
  • Sastav:
  • Urbroj: 1 ml sadrži 0,5 mg adrenalina. Pojedinačna doza (0,3 ml) sadrži 0,15 mg (150 mikrograma) adrenalina
  • Tip recepta:
  • na recept, u ljekarni neponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Meda Pharma GmbH & Co. KG, Bad Homburg, Njemačka

Dokument

Lokalizacija

  • Na raspolaganju u:
  • EpiPen Jr 0,15 mg otopina za injekciju
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 1 autoinjektor s 2 ml otopine, u kutiji [HR-H-987056369-01]; 2 autoinjektora s 2 ml otopine, u kutiji [HR-H-987056369-02] Urbroj: 381-12-01/30-18-31

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-987056369
  • Datum autorizacije:
  • 03-01-2018
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: informacije za korisnika

EpiPen Jr. 0,15 mg otopina za injekciju

adrenalin

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

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

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, ljekarnika ili medicinsku sestru.

To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi, vidjeti dio 4.

Što se nalazi u ovoj uputi:

Što je EpiPen Jr. i za što se koristi?

Što morate znati prije nego počnete primjenjivati EpiPen Jr.?

Kako primjenjivati EpiPen Jr.?

Moguće nuspojave

Kako čuvati EpiPen Jr.?

Sadržaj pakiranja i druge informacije

1.

Što je EpiPen Jr. i za što se koristi?

EpiPen Jr. je sterilna otopina u napunjenoj brizgalici (autoinjektoru) za hitnu injekciju u mišić.

EpiPen Jr. (adrenalin) autoinjektor namijenjen je za hitno liječenje teških alergijskih reakcija (anafilaksija)

uzrokovanih alergenima iz npr. hrane, lijekova, ubodima ili ugrizima kukaca, kao i potaknutih tjelesnim

naporom ili nepoznatim uzrocima.

EpiPen autoinjektori namijenjeni su za trenutačnu primjenu u bolesnika za koje je utvrđeno da imaju

povećan rizik od anafilaksije, uključujući pojedince koji imaju anafilaktičke reakcije u povijesti bolesti.

Simptomi koji upućuju na nastup anafilaktičke reakcije uključuju: svrbež kože, izdignuti osip (poput

koprivnjače); crvenilo uz osjećaj vrućine; oticanje usana, grla, jezika, šaka i stopala; piskanje; promuklost;

mučninu; povraćanje; grčeve u trbuhu i, u nekim slučajevima, gubitak svijesti.

Lijek

autoinjektoru

adrenalin,

adrenergički

lijek.

Djeluje

izravno

srčano

žilni

sustav

(srce i

cirkulaciju) i dišni sustav (pluća) suprotstavljajući se mogućim smrtonosnim učincima anafilaksije tako što

brzo sužava krvne žile, opušta mišiće u plućima radi poboljšanja disanja, smanjuje oticanje i potiče srčani

ritam.

2.

Što morate znati prije nego počnete primjenjivati EpiPen Jr.?

Nemojte primjenjivati EpiPen Jr.

Nije poznat razlog zašto netko ne bi trebao primijeniti EpiPen Jr. tijekom alergijskog hitnog stanja.

Upozorenja i mjere opreza

Obratite se svom liječniku prije nego primijenite Epipen Jr.

Ako bolujete od astme za vas postoji povećan rizik od teške alergijske reakcije.

H A L M E D

03 - 01 - 2018

O D O B R E N O

Svaka osoba koja je imala anafilaktičku epizodu bi trebala posjetiti liječnika radi testiranja na tvari na koje bi

mogla biti alergična, kako bi ih mogla izričito izbjegavati u budućnosti. Važno je znati da alergija na jednu

tvar može dovesti do alergija na više drugih srodnih tvari.

Ako ste alergični na određene namirnice, važno je provjeriti sastojke svakog proizvoda koji uzimate

(uključujući i lijekove) jer već i male količine mogu uzrokovati teške reakcije.

Obratite se svom liječniku ako imate:

bolest srca

pretjerano aktivnu štitnjaču

visoki krvni tlak

šećernu bolest (dijabetes)

povišeni tlak u oku (glaukom)

teške probleme s bubrezima

tumor prostate

visoke razine kalcija ili niske razine kalija u krvi

Parkinsonovu bolest.

U ovim stanjima povećan je rizik od pojavljivanja nuspojava adrenalina. Unatoč tome, adrenalin je ključan u

liječenju anafilaksije. Bolesnici s tim stanjima ili svi koji se mogu naći u situaciji da daju EpiPen Jr.

bolesniku koji ima alergijsku reakciju moraju biti pravilno upućeni u situacije u kojima lijek treba dati.

Djeca i adolescenti

Djeca tjelesne težine manje od 15 kg

Prikladnost EpiPena Jr. liječnik mora procijeniti pojedinačno. Ne preporučuje se primjena u djece čija je

tjelesna težina manja od 7,5 kg osim u životno ugrožavajućim situacijama i po preporuci liječnika.

Djeca i adolescenti tjelesne težine 30 kg i više

Za ovu skupinu bolesnika dostupan je EpiPen autoinjektor koji sadrži 0,3 mg (300 mikrograma) adrenalina u

jednoj dozi.

Drugi lijekovi i EpiPen Jr.

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

lijekove.

To je osobito važno ako uzimate nešto od sljedećeg:

lijekove za liječenje depresije kao što su triciklički antidepresivi ili inhibitori monoaminooksidaze

(MAO inhibitori), jer mogu pojačati učinke adrenalina

lijekove za liječenje Parkinsonove bolesti poput inhibitora katekol-O-metil transferaze (COMT) i

levodope budući da učinak adrenalina može biti veći

lijekove koji mogu učiniti srce osjetljivim na promjene otkucaja (aritimije) kao što su digitalis ili

kinidin.

beta-blokatore za bolest srca ili lijekove za liječenje poremećaja živčanog sustava, jer oni mogu

smanjiti učinak adrenalina

lijekove za bolest štitnjače

lijekove koji vam olakšavaju disanje, koji se primjenjuju kod astme (teofilin)

lijekove koji se primjenjuju kod porođaja (oksitocin)

lijekove

koji

primjenjuju

liječenje

alergija

poput

difenilhidramina

klorfeniramina

(antihistamini)

lijekove koji djeluju na živčani sustav (parasimpatolitici).

Bolesnici sa šećernom bolesti moraju pozorno nadzirati svoju razinu glukoze nakon primjene EpiPena Jr., jer

adrenalin može utjecati na količinu inzulina koju proizvodi tijelo te tako povećavati razinu glukoze u krvi.

H A L M E D

03 - 01 - 2018

O D O B R E N O

EpiPen Jr. s hranom, pićem i alkoholom

Hrana i piće nemaju utjecaja na djelovanje EpiPena Jr.

Obavijestite svog liječnika ako uzimate alkohol jer učinak adrenalina može biti povećan.

Trudnoća i dojenje

Trudnoća

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

ljekarniku za savjet prije nego što uzmete ovaj lijek.

Iskustvo primjene adrenalina u trudnoći je ograničeno. U akutnoj situaciji opasnoj za život ne oklijevajte

upotrijebiti EpiPen Jr. jer vaš život i život vašeg djeteta mogu biti u opasnosti.

Dojenje

Ne očekuje se da ovaj lijek ima ikakav učinak na dojenčad.

Upravljanje vozilima i strojevima

Nije važno.

EpiPen Jr. sadrži natrijev metabisulfit (E223) i natrijev klorid.

Natrijev metabisulfit može rijetko uzrokovati teške alergijske reakcije ili otežano disanje (bronhospazam).

Ovaj lijek sadrži manje od 1 milimola natrija (23 mg) po dozi, tj. „ne sadrži natrij“.

3.

Kako primjenjivati EpiPen Jr.?

Kada vam liječnik propiše EpiPen Jr., morate biti sigurni da razumijete zašto vam je propisan. Morate

pouzdano znati kako točno upotrebljavati uređaj. Uvijek primijenite ovaj lijek točno onako kako Vam je

rekao Vaš liječnik. Ako ste imalo nesigurni kako ga upotrebljavati, tražite od svog liječnika, medicinske

sestre ili ljekarnika da Vam ponove upute.

Preporučuje se da članovi vaše obitelji, skrbnici ili učitelji također budu obučeni za ispravnu primjenu EpiPen

Jr. Za potrebe obuke i pokazivanja dostupan je EpiPen uređaj za obuku (bez lijeka i bez igle).

Uređaj za obuku i aktivni EpiPen Jr. ne smiju se nositi zajedno kako bi se izbjegla zabuna u hitnoj situaciji.

EpiPen Jr. namijenjen je liječenju djece tjelesne težine od 15 do 30 kg.

Za odrasle, adolescente i djecu tjelesne težine veće od 30 kg dostupan je EpiPen autoinjektor koji sadrži 0,3

mg (300 mikrograma) adrenalina u jednoj dozi.

Za djecu tjelesne težine manje od 15 kg molimo pogledajte dio „Djeca i adolescenti“ u tekstu iznad.

Doziranje

Dozu će odrediti vaš liječnik koji će je prilagoditi vama. Uobičajena doza za djecu (15 – 30 kg) za alergijska

hitna stanja je 0,15 mg (150 mikrograma) adrenalina za primjenu u mišić.

Ako opazite znakove akutne alergijske reakcije, odmah upotrijebite EpiPen Jr.

Svaki EpiPen Jr. autoinjektor oslobađa jednu pojedinačnu dozu od 0,3 ml tekućine, što je jednako 0,15 mg

adrenalina. Nakon primjene mala količina tekućine ostati će u autoinjektoru ali se on ne može ponovno

upotrijebiti.

Ponekad jedna doza adrenalina možda neće biti dovoljna kako bi se potpuno poništio učinakozbiljne

alergijske reakcije. Zbog toga će vam vaš liječnik propisati više od jednog EpiPena Jr. Ako se vaši simptomi

ne poboljšaju ili dođe do njihovog pogoršanja unutar 5 – 15 minuta nakon prve injekcije, vi ili osoba s vama

H A L M E D

03 - 01 - 2018

O D O B R E N O

treba vam dati drugu injekciju.Zbog toga trebate u svakom trenutku imati sa sobom više od jednoga

EpiPena Jr.

Način primjene

EpiPen Jr. je

napravljen tako

lako

primjenjuju

ljudi bez

medicinske

obuke.

EpiPen Jr.

treba

jednostavno čvrsto ubosti u vanjski dio bedra s udaljenosti od otprilike 10 cm. Nije potrebno precizno

određivanje mjesta uboda na vanjskoj strani bedra. Kad zabodete EpiPen Jr. čvrsto u bedro, oslobodit će se

oprugom aktivirani klip, koji će gurnuti skrivenu iglu u bedreni mišić i primijeniti dozu adrenalina. Ako

nosite odjeću, EpiPen Jr. možete ubrizgati i kroz odjeću.

Upute za uporabu moraju se pozorno pratiti da bi se izbjeglo slučajno ubrizgavanje.

EpiPen Jr. treba ubrizgati isključivo u vanjsku stranu bedra. Ne smije se ubrizgati u stražnjicu zbog

rizika od slučajnog ubrizgavanja u venu.

Upozorenja: Slučajno ubrizgavanje u šake ili prste može dovesti do prestanka opskrbe krvlju u pogođenom

području. Ako se adrenalin slučajno primijeni u ta područja, ODMAH se uputite u hitnu službu najbliže

bolnice na liječenje.

Upute za primjenu

Potpuno se upoznajte s EpiPenom Jr., kada i kako ga treba primijeniti.

plavi sigurnosni prozorčić narančasti vrh

zatvarač za provjeru

Slijedite ove upute samo kad ste spremni za primjenu EpiPena Jr.

Držite autoinjektor za sredinu, nikad za krajeve. Za pravilnu primjenu pogledajte slike i pratite ove korake:

- Nikad nemojte stavljati palac, prste ili šaku preko narančastoga vrha. Nikad nemojte stiskati ili gurati

narančasti vrh palcem, prstima ili šakom.

- Igla izlazi iz narančastog vrha.

- NEMOJTE odstranjivati plavi sigurnosni zatvarač dok niste spremni za upotrebu.

Držite EpiPen Jr. dominantnom rukom

(rukom kojom pišete), tako da je palac

najbliži plavomu zatvaraču te stisnite

šaku oko uređaja (narančasti vrh mora

biti okrenut prema dolje).

Drugom rukom skinite plavi sigurnosni zatvarač.

H A L M E D

03 - 01 - 2018

O D O B R E N O

Držite EpiPen Jr. na udaljenosti od otprilike 10 cm od vanjske strane bedra

Narančasti vrh treba biti usmjeren prema vanjskoj strani bedra.

Zabodite EpiPen Jr. čvrsto u vanjsku stranu bedra pod pravim kutom (kut

od 90 stupnjeva (čut ćete „klik”).

Držite čvrsto na bedru 10 sekundi. Ubrizgavanje je gotovo i prozorčić na

autoinjektoru zatamnjen

EpiPen Jr. treba odmaknuti od bedra i kasnije zbrinuti na siguran način

(narančasti pokrov će se proširiti da pokrije izvučenu iglu).

Masirajte

područje

ubrizgavanja

sekundi.

Nazovite

112,

zatražite

hitnu

medicinsku pomoć, navedite anafilaksiju.

H A L M E D

03 - 01 - 2018

O D O B R E N O

U EpiPen Jr. autoinjektoru može biti prisutan mali mjehurić. To nema utjecaja na djelotvornost lijeka.

Iako većina tekućine (oko 90 %) ostaje u EpiPenu Jr. nakon primjene, ona se ne može ponovno upotrijebiti.

No, primili ste predviđenu dozu lijeka ako se narančasti vrh igle produljio i prozorčić za provjeru se

zatamnio. Nakon primjene odložite EpiPen Jr. na siguran način u priloženu plastičnu tubu te ga ponesite sa

sobom pri posjetu liječniku, bolnici ili ljekarni.

EpiPen Jr. Je napravljen samo za hitnu primjenu. Uvijek morate potražiti medicinsku pomoć odmah nakon

primjene EpiPena Jr. Nazovite 112, zatražite hitnu medicinsku pomoć i naglasite da je riječ o „anafilaksiji“

čak i ako se čini da se simptomi povlače. Trebat ćete otići u bolnicu na promatranje i daljnje liječenje jer se

reakcija može ponovo javiti nakon određenog vremena.

Dok čekate vozilo hitne pomoći trebate leći s podignutim nogama. Ako u tom položaju ostajete bez daha,

trebate sjesti. Zamolite nekoga da ostane s vama dok ne dođe vozilo hitne pomoći u slučaju da se opet

počnete osjećati loše.

Bolesnike bez svijesti treba položiti u bočni položaj.

Ako primijenite više EpiPena Jr. nego što ste trebali

U slučaju predoziranja ili slučajnog ubrizgavanja adrenalina morate odmah tražiti medicinsku pomoć.

4.

Moguće nuspojave

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

Prijavljeno je slučajno ubrizgavanje brizgalicom u šake ili stopala koje može za posljedicu imati gubitak

opskrbe krvlju u pogođenome području. U slučaju nehotičnog ubrizgavanja odmah potražite medicinsku

pomoć.

Kod bolesnika osjetljivih na natrijev metabisulfit mogu se javiti teške alergijske reakcije, uključujući

anafilaktičke simptome i suženje dišnih putova (bronhospazam), osobito u osoba koje boluju od astme.

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

problemi sa srcem (kardiomiopatija).

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

- nepravilan srčani ritam

- visok krvni tlak

- znojenje

- mučnina

- povraćanje

- glavobolja

- omaglica

- slabost

- nevoljno drhtanje

- nervoza ili tjeskoba.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je o njoj 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

H A L M E D

03 - 01 - 2018

O D O B R E N O

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati EpiPen Jr.?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenoga na kutiji i naljepnici .

Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Ovaj lijek čuvajte na temperaturi nižoj od 25

C. Nemojte odlagati lijek u hladnjak ili zamrzavati.

Spremnik čuvajte u vanjskom pakiranju radi zaštite od svjetlosti. Adrenalin brzo propada pri izlaganju zraku

ili svjetlosti te će postati ružičast ili smeđ. Provjerite sadržaj staklenoga uloška u EpiPen Jr.

autoinjektoru s vremena na vrijeme kako biste provjerili je li tekućina još uvijek bistra i bezbojna.

Zamijenite autoinjektor nakon isteka roka valjanosti ili prije njegova isteka ako je otopina

promijenila boju ili sadržava čestice (krutu tvar).

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 EpiPen Jr. sadrži ?

Djelatna tvar je adrenalin. Svaka doza sadrži 0,15 mg (150 mikrograma) adrenalina.

Pomoćne tvari su: natrijev klorid, natrijev metabisulfit (E223) kloridna kiselina, voda za injekcije.

Kako EpiPen Jr. izgleda i sadržaj pakiranja?

Bistra i bezbojna otopina u napunjenoj brizgalici (autoinjektoru).

Autoinjektor sadrži 2 ml otopine za injekcije. Svaki autoinjektor oslobađa jednu pojedinačnu dozu (0,3 ml)

od 0,15 mg adrenalina.

Duljina izložene i zaštićene igle je oko 13 mm.

Veličine pakiranja:

1 autoinjektor

2 x 1 autoinjektor

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet

Mylan Hrvatska d.o.o.

Koranska 2

10 000 Zagreb

Proizvođač

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

D-61352 Bad Homburg, Njemačka

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji put revidirana u siječnju 2018.

H A L M E D

03 - 01 - 2018

O D O B R E N O

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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

FDA approves first generic version of EpiPen

FDA approves first generic version of EpiPen

FDA approves the first generic version of EpiPen and EpiPen Jr for the emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds.

FDA - U.S. Food and Drug Administration

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

29-6-2018

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if t...

FDA - U.S. Food and Drug Administration

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

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Active substance: Lenvatinib) - Transfer of orphan designation - Commission Decision (2018)4080 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/287/14/T/01

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Active substance: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1) - Transfer of orphan designation - Commission Decision (2018)4088 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/150/15/T/02

Europe -DG Health and Food Safety