Dalpam 10 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Dalpam 10 mg tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: svaka tableta sadrži 10 mg diazepama
  • Tip recepta:
  • na recept, u ljekarni neponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • S.C. Santa S.A., Brasov, Rumunjska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Dalpam 10 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 10 tableta u blisteru, u kutiji [HR-H-945093839-01]; 20 tableta u blisteru, u kutiji [HR-H-945093839-02]; 25 tableta u blisteru, u kutiji [HR-H-945093839-03]; 28 tableta u blisteru, u kutiji [HR-H-945093839-04]; 30 tableta u blisteru, u kutiji [HR-H-945093839-05]; 50 tableta u blisteru, u kutiji [HR-H-945093839-06]; 60 tableta u blisteru, u kutiji [HR-H-945093839-07]; 100 tableta u blisteru, u kutiji [HR-H-945093839-08]; 100 tableta u spremniku, u kutiji [HR-H-945093839-09]; 500 tableta u spremniku, u kutiji [HR-H-945093839-10]; 1000 tableta u spremniku, u kutiji [HR-H-945093839-11] Urbroj: 381-12-01/30-17-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-945093839
  • Datum autorizacije:
  • 19-01-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Dalpam 2 mg tablete

Dalpam 5 mg tablete

Dalpam 10 mg tablete

diazepam

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.

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

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti 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 Dalpam

i za što se koristi

Što morate znati prije nego počnete uzimati Dalpam

Kako uzimati Dalpam

Moguće nuspojave

Kako čuvati Dalpam

Sadržaj pakiranja i druge informacije

1.

Što je Dalpam i za što se koristi

Dalpam sadrži djelatnu tvar diazepam koji se ubraja u skupinu lijekova koji se zovu benzodiazepini.

Dalpam ima anksiolitički i sedativni učinak te učinak na opuštanje mišića.

Dalpam se koristi za:

liječenje tjeskobnih stanja

liječenje grčeva mišića, uključujući i one uzrokovane cerebralnom spastičnošću (potječu iz

mozga)

liječenje simptoma ustezanja od alkohola

sedaciju prije operacije (premedikacija).

Vaš liječnik može Vam propisati Dalpam za drugu upotrebu. Pridržavajte se uputa liječnika.

2.

Što morate znati prije nego počnete uzimati Dalpam

Nemojte uzimati Dalpam:

ako ste

alergični

na diazepam ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)

ako bolujete od bolesti koja se zove

miastenija gravis

, a koja uzrokuje slabljenje i brz umor

mišića

ako bolujete od apneje u snu (poremećaj spavanja gdje se javljaju abnormalne pauze u disanju

tijekom sna)

ako imate

tešku bolest jetre

ako imate

akutnu depresiju disanja

(sporo i/ili plitko disanje).

Upozorenja i mjere opreza

Obratite se svom liječniku prije nego uzmete Dalpam:

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O D O B R E N O

ako ste bili

ovisni o alkoholu ili drogama

ako ste

starija osoba

. Dalpam može uzrokovati smetenost i imati učinak na mišiće zbog čega

može doći do pada i ozljeda.

ako imate

problema sa disanjem

ako bolujete od

depresije

ako imate

suicidalne misli

ako bolujete od

epilepsije

ili ste nekad doživjeli

napadaje

Ostala razmatranja

psihičke nuspojave

– obavijestite svog liječnika ukoliko doživite nuspojave kao što su

uznemirenost, hiperaktivnost, nemir, agresivnost, noćne more ili halucinacije. Vjerojatnije je

da će se ove nuspojave javiti u djece i starijih.

amnezija

– možete doživjeti gubitak pamćenja kod uzimanja ovog lijeka. Vjerojatnije je da će

se gubitak pamćenja javiti kod uzimanja većih doza lijeka.

ovisnost

– kod uzimanja ovog lijeka postoji rizik od razvoja ovisnosti, što se povećava sa

dozom i trajanjem liječenja te u bolesnika koji su bili ovisni o alkoholu ili drogama. Zbog toga

Dalpam treba uzimati što je kraće moguće.

navikavanje

– ako Vam se nakon nekoliko tjedana uzimanja lijeka čini da više ne djeluje kao

što je djelovao na početku liječenja, obratite se svom liječniku.

ustezanje

– liječenje treba postupno prekidati. Simptomi ustezanja mogu se javiti i kod

kratkotrajne primjene Dalpama u uobičajenim terapijskim dozama. Vidjeti dio 3

„Ako

prestanete uzimati Dalpam“.

Djeca i adolescenti

Nemojte davati ovaj lijek djeci mlađoj od 6 godina.

Drugi lijekovi i Dalpam

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

druge lijekove. To se naročito odnosi na:

cimetidin, omeprazol i esomeprazol (koriste se u liječenju ulkusa na želudcu i žgaravice)

lijekove za epilepsiju (antiepileptike)

lijekove za liječenje depresije (antidepresivi) ili lijekove za liječenje psihičkih problema

(antipsihotici)

lijekove za liječenje alergija koji imaju sedirajući učinak (antihistaminici)

lijekove za liječenje nesanice (hipnotici) ili za liječenje tjeskobe (trankvilizatori)

neke snažne lijekove protiv boli (analgetici kao primjerice morfin) i disulfiram (za liječenje

ovisnosti o alkoholu)

rifampicin i izoniazid (antibiotici) i ketokonazol (antimikotik)

atazanavir i ritonavir (antivirotici)

propranolol (za sniženje krvnog tlaka)

teofilin (za liječenje astme).

Dalpam s hranom, pićem i alkoholom

Nemojte piti alkohol

dok uzimate diazepam. Alkohol može pojačati sedativni učinak Dalpama i

učiniti Vas jako pospanim.

Nemojte piti

sok od grejpa

dok uzimate diazepam jer on usporava izlučivanje diazepama iz tijela i

povećava rizik od nuspojava.

Trudnoća, dojenje i plodnost

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Nemojte uzimati Dalpam ako ste trudni, planirate imati dijete ili dojite.

Ako uzmete Dalpam na kraju trudnoće ili tijekom poroda Vaše dijete može imati nisku tjelesnu

temperaturu, mlohavost i poteškoće sa disanjem. Ako lijek uzimate redovito na kraju trudnoće, Vaše

dijete može razviti simptome ustezanja.

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Upravljanje vozilima i strojevima

Dalpam Vas može učiniti pospanim i utjecati na koncentraciju. Može utjecati i na rad Vaših mišića.

Ovi učinci mogu trajati i nekoliko dana nakon prestanka uzimanja diazepama.

Nemojte

voziti niti

koristiti alat ili strojeve ako na Vas ima ovakav učinak.

Dalpam sadrži laktozu hidrat

Ako Vam je liječnik rekao da ne podnosite neke vrste šećera, obavijestite svog liječnika prije nego

počnete uzimati ovaj lijek.

3.

Kako uzimati Dalpam

Uvijek uzimajte ovaj lijek točno onako kako Vam je rekao liječnik. Provjerite s liječnikom ili

ljekarnikom ako niste sigurni.

Vaš liječnik će odrediti dozu prikladnu za Vas i koliko dugo trebate uzimati lijek. Liječenje obično ne

traje duže od 4 tjedna. Ukoliko je to potrebno, liječnik može produljiti trajanje liječenja.

Preporučena doza je:

Odrasli

Za anksioznost

: 2 mg do 5 mg diazepama dva do tri puta dnevno. Doza se može povećati na

maksimalno 30 mg dnevno podijeljeno u dvije do četiri doze.

Za liječenje grčeva mišića

: do 15 mg diazepama dnevno podijeljeno u dvije do četiri doze.

Za liječenje grčeva mišića u cerebralnoj spastičnosti

: do maksimalno 60 mg dnevno podijeljeno u tri

do četiri doze.

Za liječenje simptoma ustezanja od alkohola

: 5 mg do 20 mg diazepama što se može ponoviti

jedanput nakon dva do četiri sata ukoliko je to potrebno, ili 10 mg diazepama tri do četiri puta prvog

dana liječenja. Nakon prvog dana, doza se obično smanje na 5 mg diazepama tri do četiri puta dnevno

ukoliko je potrebo. U teškim slučajevima Vaš liječnik može odrediti druge načine liječenja, a liječenje

će se možda morati odvijati u bolnici.

Premedikacija prije operacije

: 5 mg do 20 mg diazepama jedanput.

Primjena u djece i adolescenata

Djeca starija od 6 godina (teža od 20 kg)

Liječnik će odrediti koliko Dalpama treba uzeti i koliko često. Uobičajena doza iznosi 0,1 do 0,3

mg/kg tjelesne mase dnevno podijeljeno u dvije do četiri doze.

Ne preporučuje se primjena Dalpama u djece mlađe od 6 godina zbog mogućih poteškoća sa gutanjem.

Tabletu progutajte sa čašom vode.

Tableta se može razdijeliti na jednake doze.

Stariji bolesnici

Ako ste stariji ili oslabljeni postoji mogućnost da ste osjetljiviji na učinke Dalpama i Vašu dozu treba

smanjiti. Vaš liječnik će odrediti koliko Dalpama trebate uzimati i koliko često. Uobičajena početna

doza je 2 mg do 2,5 mg jednom ili dva puta dnevno.

Oštećena funkcija bubrega

Prilagodba doze obično nije potrebna.

Oštećena funkcija jetre

Ukoliko bolujete od ciroze jetre ili imate druge probleme s jetrom, Vašu dozu treba smanjiti.

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Pretili bolesnici

Ukoliko ste pretili, postoji mogućnost da će trebati više vremena kako bi lijek djelovao. Nadalje,

učinci Dalpama mogu trajati dulje, uključujući i nuspojave.

Ako uzmete više Dalpama nego što ste trebali

Ako ste uzeli puno tableta (više nego Vam je propisano), ili ukoliko mislite da je dijete progutalo

tabletu, odmah se javite najbližoj bolnici ili svome liječniku.

Simptomi koji se javljaju kod predoziranja diazepamom su gubitak koordinacije pokreta, pospanost,

smetenost, otežan govor i slabost mišića. Teško predoziranje može dovesti do kome, niske tjelesne

temperature (hipotermija), niskog krvnog tlaka, usporenog pulsa i ozbiljnih poteškoća sa disanjem.

Ako ste zaboravili uzeti Dalpam

Ako ste zaboravili uzeti Dalpam, uzmite dozu čim se sjetite. Ukoliko trebate uzeti iduću dozu,

preskočite zaboravljenu. Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Dalpam

Nemojte prestati uzimati lijek bez savjetovanja s liječnikom. Trebali biste postupno smanjivati

broj ili jačinu tableta prije nego ih u potpunosti prestanete uzimati.

Ako naglo prestanete uzimati Dalpam, mogu Vam se javiti simptomi ustezanja uključujući:

tjeskobu, napade panike, palpitacije (snažni i udarni otkucaji srca), znojenje, nevoljno

drhtanje, problemi u želudcu, razdražljivost, agresivnost, poremećaji osjeta, grčevi u mišićima,

opće slabo stanje, gubitak teka, nesanica, psihičke nuspojave kao što su teška smetenost i

napadaji.

Vjerojatnost i ozbiljnost simptoma ustezanja ovisi o trajanju liječenja, jačini doze i stupnju

ovisnosti.

Ako bolujete od epilepsije ili ste imali napadaje i naglo prestanete uzimati Dalpam, postoji

rizik od konvulzija ili dugotrajnog epileptičnog napadaja. Postoji rizik od napadaja i imate

problem s ovisnošću o alkoholu ili drogama i naglo prestanete uzimati Dalpam.

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

4.

Moguće nuspojave

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

Obavijestite svog liječnika

ukoliko uočite bilo koju od sljedećih nuspojava, uključujući i one koje

nisu navedene:

Neke nuspojave mogu biti ozbiljne i mogu zahtijevati hitno liječničko liječenje:

Manje često: može se javiti u do 1 na 100 ljudi

depresija disanja (vrlo sporo i/ili plitko disanje).

Rijetko: može se javiti u do 1 na 1000 ljudi

respiratorni arest (prestanak disanja)

nesvjestica

žutica (žuta boja kože ili bjeloočnice).

Vrlo rijetko: može se javiti u do 1 na 10 000 ljudi

anafilaksija (teška alergijska reakcija) sa simptomima kao što su naglo piskanje, oticanje

usana, jezika i grla ili tijela, osip, nesvjestica ili poteškoće sa gutanjem.

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Ostale nuspojave:

Vrlo često: mogu se javiti u više od 1 na 10 ljudi

omamljenost

Često: može se javiti u do 1 na 10 ljudi

umor

simptomi ustezanja (za moguće simptome vidjeti dio „Ako prestanete uzimati Dalpam“ u

dijelu 3)

smetenost

gubitak koordinacije mišićnih pokreta (ataksija) i ostali poremećaji pokreta, tremor.

Manje često: može se javiti u do 1 na 100 ljudi

mišićna slabost

gubitak pamćenja

poteškoće u koncentraciji

poremećaji ravnoteže

omaglica

glavobolja

otežan govor

poteškoće u probavnom sustavu kao što su mučnina, povraćanje, zatvor, dijareja

povećano lučenje sline

kožne alergijske reakcije u obliku svrbeža, crvenila kože i oticanje te osip kože

Rijetko: može se javiti u do 1 na 1000 ljudi

psihičke nuspojave kao što su uzbuđenost, uznemirenost, nemir, razdražljivost, agresivnost,

gubitak pamćenja, deluzije (lažna uvjerenja), bijes, psihoze, noćne more ili halucinacije. Mogu

biti ili postati ozbiljne. Veća je vjerojatnost da će se ove nuspojave javiti u djece ili starijih.

Obavijestite svog liječnika.

smanjena pozornost

depresija

emocionalna osiromašenost

nesanica (problemi sa spavanjem)

problemi sa srcem kao što su usporen srčani ritam (bradikardija), zatajenje srca i prestanak

rada srca (srčani udar)

nizak krvni tlak, nesvjestica (sinkopa)

povećano stvaranje mukusa u plućima

suhoća usta

povećan tek

promjene u određenim jetrenim enzimima što se vidi kod pretraga krvi

gubitak sposobnosti za uriniranje, gubitak kontrole mjeruha (propuštanje urina)

povećanje dojki u muškaraca

impotencija, promjene u spolnom nagonu (libido).

Vrlo rijetko: može se javiti u do 1 na 10000 ljudi

niske razine bijelih krvnih stanica u krvi (leukopenija)

povišene razine određenih enzima u krvi (transaminaze).

Nepoznato: učestalost se ne može procijeniti na temelju dostupnih podataka

zamućenje vida, dvoslike i nevolji pokreti oka (ove nuspojave se povuku nakon što prestanete

uzimati diazepam).

Ukoliko bilo koja od ovih nuspojava postane ozbiljna, ili uočite bilo koje nuspojave koje nisu

navedene u ovoj uputi, obavijestite svog liječnika ili ljekarnika.

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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 Dalpam

Lijek čuvajte izvan pogleda i dohvata djece.

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

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

Ovaj lijek ne zahtjeva posebne uvjete čuvanja.

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 Dalpam sadrži

Jedna tableta sadrži 2 mg, 5 mg ili 10 mg diazepama.

Djelatna tvar je diazepam.

Drugi sastojci su: laktoza hidrat, prethodno geliran kukuruzni škrob i magnezijev stearat.

Kako Dalpam izgleda i sadržaj pakiranja

Dalpam 2 mg tablete: bijele do gotovo bijele, okrugle, ravne tablete promjera 8,0 mm, s utisnutim „2“

na jednoj strani i urezom na drugoj strani.

Dalpam 5 mg tablete: bijele do gotovo bijele, okrugle, ravne tablete promjera 8,0 mm, s utisnutim „5“

na jednoj strani i urezom na drugoj strani.

Dalpam 10 mg tablete: bijele do gotovo bijele, okrugle, ravne tablete promjera 8,0 mm, s utisnutim

„10“ na jednoj strani i urezom na drugoj strani.

Al/PVC blisteri i HDPE spremnici s bijelim PE zatvaračima.

Al/PVC blisteri

Veličine pakiranja: 10, 20, 25, 28, 30, 50, 60 i 100 tableta

HDPE spremnici

Veličine pakiranja: 100, 500 i 1000 tableta

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

Neogen NV, Square Marie Curie 50, 1070 Anderlecht, Belgija

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Proizvođač

S.C. SANTA S.A., Str. Carpatilor nr. 60, Obiectiv nr. 47, 48, 58, 133, 156, Brasov, jud. Brasov, cod

500269, Rumunjska

Predstavnik nositelja odobrenja za Republiku Hrvatsku:

Sandoz d.o.o.

Maksimirska 120

10000 Zagreb

Tel: + 385 1 2353111

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

sljedećim nazivima:

Nizozemska

Dalpam

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u siječnju 2017.

H A L M E D

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11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

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

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

Recently Updated Records for the Week of July 25, 2018 Last Modified Date: Friday, August 10, 2018

FDA - U.S. Food and Drug Administration

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5045 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/10/T/01

Europe -DG Health and Food Safety