Terlok 100 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Terlok 100 mg filmom obložene tablete
  • Doziranje:
  • 100 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna filmom obložena tableta sadrži 100 mg erlotiniba (u obliku erlotinibklorida)
  • Tip recepta:
  • na recept, u ljekarni ograničeni recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Genepharm S.A., Pallini Attiki, Grčka; Pharmadox Healthcare Limited, Paola PLA, Malta

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Terlok 100 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-661193462-01] Urbroj: 381-12-01/70-16-08

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-661193462
  • Datum autorizacije:
  • 29-12-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

Terlok 25 mg filmom obložene tablete

Terlok 100 mg filmom obložene tablete

Terlok 150 mg filmom obložene tablete

erlotinib

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

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

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im 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, vidjeti dio 4.

Što se nalazi u ovoj uputi

1. Što je Terlok i za što se koristi?

2. Što morate znati prije nego počnete uzimati Terlok?

3. Kako uzimati Terlok?

4. Moguće nuspojave

5. Kako čuvati Terlok?

6. Sadržaj pakiranja i druge informacije

1. Što je Terlok i za što se koristi?

Terlok sadrži djelatnu tvar erlotinib. Terlok je lijek namijenjen liječenju raka, koji djeluje

tako što sprječava aktivnost proteina zvanog receptor epidermalnog faktora rasta (engl.

Epidermal

Growth Factor Receptor

, krat. EGFR). Poznato je da taj protein sudjeluje u rastu i širenju stanica raka.

Terlok je namijenjen liječenju odraslih bolesnika. Lijek Vam može biti propisan ako imate

rak pluća nemalih stanica u uznapredovalom stadiju. Može Vam biti propisan kao početno

liječenje, ili kao lije

enje nakon po

etne kemoterapije ako je bolest nakon nje ostala uglavnom

nepromijenjena, pod uvjetom da stanice Vašega raka imaju specifične mutacije EGFR. Također može

biti propisan ako prethodna kemoterapija nije uspjela zaustaviti Vašu bolest.

Ovaj Vam lijek također može biti propisan u kombinaciji s drugim lijekom pod nazivom gemcitabin

ako imate rak gušterače u metastatskom stadiju.

2. Što morate znati prije nego počnete uzimati Terlok?

Nemojte uzimati Terlok

ako ste alergični na erlotinib ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.).

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Terlok.

ako uzimate druge lijekove koji mogu povećati ili smanjiti razinu erlotiniba u krvi ili utjecati

na njegov učinak (kao što su lijekovi protiv gljivica poput ketokonazola, inhibitori proteaze,

eritromicin, klaritromicin, fenitoin, karbamazepin, barbiturati, rifampicin, ciprofloksacin,

omeprazol, ranitidin, gospina trava ili inhibitori proteasoma) obratite se Vašem liječniku. U

nekim slučajevima ti lijekovi mogu umanjiti djelotvornost ili pojačati nuspojave lijeka Terlok,

pa Vaš liječnik može trebati prilagoditi dozu. Možda će liječnik izbjegavati liječenje tim

lijekovima dok primate Terlok.

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O D O B R E N O

ako uzimate antikoagulanse (lijekove koji pomažu spriječiti nastanak tromboze ili krvnih

ugrušaka poput varfarina) Terlok može povećati sklonost krvarenju. Obratite se Vašem

liječniku koji će morati redovito pratiti Vaše krvne nalaze.

ako uzimate statine (lijekove za sniženje razine kolesterola u krvi), Terlok može povećati rizik

nastanka problema s mišićima povezanih sa statinima, koji u rijetkim slučajevima mogu

dovesti do ozbiljne razgradnje mišića (rabdomiolize) i posljedičnog oštećenja bubrega,

obratite se Vašem liječniku.

ako koristite kontaktne leće i/ili ste već imali tegobe s očima poput izuzetno suhih očiju, upale

prednjega dijela oka (rožnice) odnosno ulceracije na prednjem dijelu oka, svakako o tome

obavijestite Vašeg liječnika.

Pogledajte također niže “Drugi lijekovi i Terlok”.

Trebate obavijestiti liječnika:

u slučaju iznenadne pojave

poteškoća s disanjem popraćenih kašljem ili vrućicom, jer će Vam

liječnik možda morati propisati druge lijekove i obustaviti liječenje lijekom Terlok,

ako imate proljev, jer će Vam liječnik možda morati propisati antidijaroik (na primjer,

loperamid),

odmah, ako patite od jakog i dugotrajnog proljeva, mučnine, gubitka apetita ili povraćanja, jer

će Vam liječnik možda morati obustaviti liječenje lijekom Terlok i

uputiti Vas na bolničko

liječenje,

ako imate jake bolove u trbuhu, teške promjene na koži u obliku mjehurića ili ljuštenja kože.

Vaš liječnik će možda odlučiti da trebate privremeno ili stalno prekinuti terapiju.

ako dođe do razvoja akutnog ili pogoršanja crvenila i bola u očima, pojačanoga suzenja,

zamućenja vida i/ili osjetljivosti na svjetlo, odmah obavijestite Vašeg liječnika ili medicinsku

sestru, jer Vam je možda potrebno hitno liječenje (vidjeti niže dio "Moguće nuspojave").

ako također uzimate statine, a pojavi Vam se neobjašnjiva bol u mišićima, osjetljivost, slabost

mišića ili grčevi. Vaš liječnik će možda odlučiti da trebate privremeno ili stalno prekinuti

terapiju.

Pogledajte i dio 4 “Moguće nuspojave”.

Bolest jetre ili bubrega

Nije poznato ima li Terlok različit učinak ako jetra ili bubrezi ne rade normalno. Liječenje ovim

lijekom ne preporučuje se ako imate tešku bolest jetre ili tešku bolest bubrega.

Poremećaj glukuronidacije poput Gilbertovog sindroma

Ako patite od poremećaja glukuronidacije, kao što je Gilbertov sindrom, liječnik Vas mora liječiti uz

povećani oprez.

Pušenje

Ako se liječite lijekom Terlok preporučuje se da prestanete pušiti jer pušenje može smanjiti razinu

lijeka u krvi.

Djeca i adolescenti

Terlok nije ispitan u bolesnika mlađih od 18 godina. Liječenje ovim lijekom ne preporučuje se djeci

i adolescentima.

Drugi lijekovi i Terlok

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

druge lijekove.

Terlok s hranom i pićem

Ne uzimajte Terlok s hranom. Pogledajte i dio 3 „Kako uzimati Terlok“.

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Trudnoća i dojenje

Tijekom liječenja lijekom Terlok izbjegavajte trudnoću. Ako biste mogli zatrudnjeti, tijekom

liječenja i barem još 2 tjedna nakon uzimanja posljednje tablete koristite odgovarajuću kontracepciju.

Ako zatrudnite tijekom terapije lijekom Terlok, odmah obavijestite liječnika koji će odlučiti treba li

liječenje nastaviti.

Ne dojite dijete ako ste na terapiji lijekom Terlok.

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Upravljanje vozilima i strojevima

Nije ispitano moguće djelovanje lijeka Terlok na sposobnost upravljanja motornim vozilima i

strojevima, ali malo je vjerojatno da će liječenje utjecati na tu sposobnost.

Preosjetljivost

Terlok sadrži šećer zvan laktoza hidrat.

Ako Vam je liječnik rekao da ne podnosite neke šećere,

savjetujte se s liječnikom

prije uzimanja lijeka

Terlok.

3. Kako uzimati Terlok?

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

ili ljekarnikom ako niste sigurni.

Tabletu trebate uzeti barem jedan sat prije ili dva sata nakon obroka.

Ako imate rak pluća nemalih stanica, uobičajena doza je jedna tableta lijeka Terlok od 150 mg

dnevno.

Ako imate metastatski rak gušterače, uobičajena doza je jedna tableta lijeka Terlok od 100 mg dnevno.

Terlok se daje u kombinaciji s terapijom gemcitabinom.

Lije

e Vam možda prilagoditi dozu smanjivanjem doze za po 50 mg. Za razli

ite sheme

doziranja Terlok je dostupan u ja

inama od 25 mg, 100 mg ili 150 mg.

Ako uzmete više lijeka Terlok nego što ste trebali

Odmah se obratite liječniku ili ljekarniku.

Nuspojave se mogu pojačati, pa će Vam liječnik možda zaustaviti liječenje.

Ako ste zaboravili uzeti Terlok

Ako preskočite jednu ili više doza lijeka Terlok, obratite se liječniku ili ljekarniku što je brže

moguće.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Terlok

Važno je Terlok uzimati svaki dan tijekom razdoblja koje Vam je propisao liječnik.

Ako imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili

ljekarniku.

4. Moguće nuspojave

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

Ako patite od bilo koje od niže navedenih nuspojava obratite se liječniku što je moguće prije. U nekim

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O D O B R E N O

će slučajevima liječnik morati smanjiti dozu lijeka Terlok ili obustaviti liječenje.

Proljev i povraćanje (vrlo često: mogu se javiti u više od 1 na 10 osoba). Dugotrajan i težak

proljev može uzrokovati nisku razinu kalija u krvi i poremećaj funkcije bubrega, osobito ako

istodobno primate i druge oblike kemoterapije. Ako imate težak ili dugotrajan proljev,

odmah

se obratite Vašem liječniku

jer Vam je možda potrebno bolničko liječenje.

Iritacija oka uslijed konjunktivitisa/keratokonjunktivitisa (vrlo često: može se javiti u više od 1

na 10 osoba) i keratitis (često: može se javiti kod manje od 1 na 10 osoba).

Oblik iritacije pluća poznate pod nazivom intersticijska bolest pluća (manje često u europskih

bolesnika; često u japanskih bolesnika: može se javiti u manje od 1 na 100 osoba u Europi i u

manje od 1 na 10 osoba u Japanu). Ta bolest može biti povezana s prirodnim tijekom Vaše

bolesti i u nekim slučajevima može imati smrtni ishod. Ako Vam se pojave simptomi kao što

su iznenadne poteškoće s disanjem popraćene kašljem ili vrućicom, odmah se obratite

liječniku

jer možda patite od te bolesti. Vaš će liječnik odlučiti treba li trajno prekinuti

liječenje lijekom Terlok.

Opažena su puknuća (perforacije) u probavnom sustavu (manje često: mogu se javiti u manje

od 1 na 100 osoba). Recite Vašem liječniku ako imate jaku bol u trbuhu. Također recite

Vašem liječniku ako ste imali peptički vrijed (čir) ili divertikularnu bolest, jer to može

povećati rizik.

U rijetkim slučajevima opaženo je zatajenje jetre (rijetko: može se javiti u manje od 1 na 1000

osoba). Ako krvne pretrage upućuju na ozbiljne promjene u funkciji jetre, možda će Vaš

liječnik morati prekinuti Vaše liječenje.

Vrlo česte nuspojave

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

Osip koji se može pojaviti ili pogoršati na područjima kože koja su izložena suncu. Ako ste

izloženi suncu, preporučljivo je nošenje zaštitne odjeće, i/ili primjena sredstva za zaštitu od

sunca (npr. koje sadrže minerale).

Infekcija,

Gubitak apetita, smanjenje tjelesne težine,

Depresija,

Glavobolja, promjena osjeta na koži ili osjećaj obamrlosti u udovima,

Poteškoće s disanjem, kašalj,

Mučnina,

Iritacija usta,

Bol u trbuhu, probavne tegobe i nadimanje,

Promijenjeni nalazi jetrenih proba,

Svrbež, suha koža i gubitak kose,

Umor, vrućica, tresavica.

Česte nuspojave

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

krvarenje iz nosa,

krvarenje u trbuhu ili crijevima,

upalne reakcije oko nokta,

infekcija folikula dlake,

akne,

raspucana koža (kožne fisure)

smanjena funkcija bubrega (kada se daje izvan odobrenih indikacija u kombinaciji s

kemoterapijom).

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Manje česte nuspojave

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

promjene na trepavicama,

prekomjerna dlakavost muškog tipa po tijelu i licu,

promjene na obrvama,

lomljivi i labavi nokti.

Rijetke nuspojave

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

crveni ili bolni dlanovi ili tabani (sindrom palmarno-plantarne eritrodizestezije).

Vrlo rijetke nuspojave

(mogu se javiti u manje od 1 na 10000 osoba):

slučajevi oštećenja ili puknuća rožnice

vrlo izraženo stvaranje mjehura na koži ili ljuštenje kože (ukazuje na Stevens-Johnsonov

sindrom)

upala obojenog dijela oka.

Prijavljivanje nuspojava

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

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem

nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5. Kako čuvati Terlok?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake

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

Ovaj lijek ne zahtijeva posebne uvjete čuvanja.

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

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

6. Sadržaj pakiranja i druge informacije

Što Terlok sadrži

Djelatna tvar

lijeka Terlok je erlotinib. Jedna filmom obložena tableta sadrži 25 mg, 100 mg

ili 150 mg erlotiniba (u obliku erlotinibklorida).

Drugi sastojci

Jezgra tablete

: laktoza hidrat, mikrokristalična celuloza, natrijev škroboglikolat vrste A,

natrijev laurilsulfat, (pogledajte također dio 2 vezano uz laktozu hidrat).

Ovojnica tablete

Opadry 03B28796 bijeli (hipromeloza 6cP (E464), titanijev dioksid (E171), makrogol 400

(E1521)).

Kako Terlok izgleda i sadržaj pakiranja?

Terlok 25 mg filmom obložene tablete

Terlok 25 mg su bijele, okrugle, bikonveksne filmom obložene tablete promjera 6,1 mm, s utisnutom

oznakom "N25" na jednoj strani te bez oznaka na drugoj strani, a dostupne su u blister pakiranju od 30

tableta.

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O D O B R E N O

Terlok 100 mg filmom obložene tablete

Terlok 100 mg su bijele, okrugle, bikonveksne filmom obložene tablete promjera 9,1 mm, s utisnutom

oznakom "N100" na jednoj strani te bez oznaka na drugoj strani, a dostupne su u blister pakiranju od

30 tableta.

Terlok 150 mg filmom obložene tablete

Terlok 150 mg su bijele, okrugle, bikonveksne filmom obložene tablete promjera 10,1 mm, s

utisnutom oznakom "N150" na jednoj strani te bez oznaka na drugoj strani, a dostupne su u blister

pakiranju od 30 tableta.

Nositelj odobrenja za stavljanje gotovog lijeka u promet

Edicta Pharm d.o.o., Klaićeva 62, Zagreb, Hrvatska

Proizvođač

1. Genepharm S.A., 18 kn Marathonos Avenue, 153 51 Pallini Attiki, Grčka

2. Pharmadox Healthcare Ltd, KW 20A Kordin Industrial Park, Paola, PLA 3000, Malta

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji put revidirana u prosincu 2016.

H A L M E D

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O D O B R E N O

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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

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

20-9-2018

Vacant position at IMA's Quality Assessment Team

Vacant position at IMA's Quality Assessment Team

The Agency advertises vacancy for expert in Quality Assessment Team in Assessment Division. The Agency is looking for strong candidate who are willing to work on challenging and interesting tasks. The vacancy is a full position (100%).

IMA - Icelandic Medicines Agency

12-9-2018

Kabinet investeert in eerste 1000 dagen kind

Kabinet investeert in eerste 1000 dagen kind

Van kinderwens tot 2-jarige peuter: de ontwikkeling die we in de eerste 1000 dagen als kind meemaken is cruciaal voor zowel een gezonde groei als de ontplooiing en kansen op latere leeftijd. Verreweg de meeste kinderen in Nederland groeien veilig en gezond op. Toch heeft ongeveer 14% van de kinderen in Nederland een ‘valse’ start door vroeggeboorte, een te laag geboortegewicht of een combinatie van beide. Minister Hugo de Jonge (VWS), gemeenten, partijen uit de geboortezorg en de jeugdgezondheidszorg (JG...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety