Lamal 200 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Lamal 200 mg tablete
  • Doziranje:
  • 200 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 200 mg lamotrigina
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Alkaloid - int d.o.o., Ljubljana, Slovenija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Lamal 200 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-889804751-01] Urbroj: 381-12-01/70-17-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-889804751
  • Datum autorizacije:
  • 16-11-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Lamal 25 mg tablete

Lamal

50 mg tablete

Lamal

100 mg tablete

Lamal

200 mg tablete

lamotrigin

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

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

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

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti Vašeg

liječnika ili ljekarnika. To

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte

dio 4.

Što se nalazi u ovoj uputi:

Što je Lamal i za što se koristi?

Što morate znati prije nego počnete uzimati Lamal?

Kako uzimati Lamal?

Moguće nuspojave

Kako čuvati Lamal?

Sadržaj pakiranja i druge informacije

1.

Što je Lamal i za što se koristi?

Lamal sadrži djelatnu tvar lamotrigin. Pripada skupini lijekova koji se zovu antiepileptici i koristi se za

liječenje epilepsije i bipolarnog poremećaja.

Lamal liječi epilepsiju blokiranjem signala u mozgu koji pokreću epileptičke napadaje.

Za odrasle i djecu od 13 godina i stariju, Lamal se može primjenjivati sam ili uz druge

lijekove u liječenju epilepsije. Lamal može takoĎer biti primjenjivan s drugim lijekovima u

liječenju napadaja koji se pojavljuju uz stanje koje se naziva Lennox-Gastautov sindrom.

Za djecu od 2 do 12 godina starosti, Lamal se može primjenjivati s drugim lijekovima u

liječenju navedenih stanja. Ovaj lijek se može koristiti kao samostalna terapija u

liječenju jedne vrste epilepsije koja se naziva tipični apsans.

Lamal takoĎer liječi bipolarni poremećaj.

Osobe s bipolarnim poremećajem (koji se ponekad naziva manična depresija) imaju ekstremne

promjene raspoloženja, s razdobljima manije (uzbuĎenje ili euforija) koja se izmjenjuju s razdobljima

depresije (duboka tuga ili očaj). Za odrasle od 18 i više godina, Lamal se može primjenjivati sam ili s

drugim lijekovima u prevenciji razdoblja depresije koje se javlja u bipolarnom poremećaju. Još uvijek

nije poznat točan mehanizam kako Lamal djeluje u mozgu te ostvaruje ovaj učinak.

2.

Što morate znati prije nego počnete uzimati Lamal?

Nemojte uzimati Lamal:

ako ste alergični na lamotrigin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).

Ako se ovo odnosi na Vas:

Obavijestite Vašeg liječnika i ne uzimajte Lamal.

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Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Lamal:

ako imate bilo kakvih problema s bubrezima;

ako ste se ikada prije liječili Lamalom ili drugim lijekovima za epilepsiju ili bipolarni

poremećaj i tijekom liječenja dobili osip;

ako ste ikada razvili meningitis nakon uzimanja lamotrigina (pročitajte opis simptoma u

dijelu 4. ove upute, podnaslov ''Rijetke nuspojave'');

ako već uzimate lijekove koji sadrže lamotrigin.

Ako se nešto od ovoga odnosi na Vas:

Obavijestite liječnika, koji može odlučiti o snižavanju doze ili odlučiti da Lamal nije pogodan lijek

za Vas.

Važne informacije o reakcijama potencijalno opasnim po život

Mali broj ljudi koji uzimaju Lamal dobije alergijsku reakciju ili potencijalno po život opasnu reakciju

na koži, koja se može razviti u ozbiljnije stanje ako se ne liječi. To može uključivati Stevens-

Johnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) i reakciju na lijek s eozinofilijom i

sistemskim simptomima (engl. Drug Rash with Eosinophilia and Systemic Symptoms, DRESS).

Potrebno je poznavati simptome na koje treba paziti tijekom primjene Lamala.

Pročitajte opis ovih simptoma u dijelu 4. ove upute pod ―Reakcije potencijalno opasne po život:

odmah potražite liječničku pomoć”.

Misli o samoozljeĎivanju ili samoubojstvu

Antiepileptici se primjenjuju za liječenje nekoliko stanja, uključujući epilepsiju i bipolarni poremećaj.

Osobe s bipolarnim poremećajem mogu ponekad imati misli o samoubojstvu ili o samoozljeĎivanju.

Ako imate bipolarni poremećaj, veća je vjerojatnost da ćete razmišljati o spomenutom:

kada prvi puta počinjete s liječenjem

ako ste već od ranije imali misli o samoozljeĎivanju ili samoubojstvu

ako ste mlaĎi od 25 godina.

Mali broj ljudi s epilepsijom, liječenih antiepilepticima kao što je Lamal takoĎer je imao misli o

samoozljeĎivanju ili samoubojstvu.

Ako imate uznemirujuće misli ili iskustva, ili ako primijetite da se osjećate gore, ili razvijete nove

simptome dok uzimate lijek:

Obratite se liječniku ili se javite u najbližu bolnicu, što je prije moguće.

Možda će Vam pomoći ako obavijestite člana obitelji, skrbnika ili bliskog prijatelja da možete

postati depresivni ili da imate značajne promjene raspoloženja te ih zamolite da pročitaju ovu

uputu. Možete ih zamoliti da Vas upozore ako su zabrinuti zbog Vaše depresije ili drugih

promjena u Vašem ponašanju.

Ako uzimate Lamal za epilepsiju

Napadaji u pojedinim tipovima epilepsije mogu se povremeno pogoršati ili se češće pojavljivati dok

uzimate Lamal. Neki bolesnici mogu iskusiti teške napadaje, koji mogu izazvati ozbiljne zdravstvene

probleme. Ako su Vaši napadaji češći, ili ako dobijete teški napadaj dok uzimate Lamal:

Obratite se liječniku što je prije moguće.

Lamal se ne smije davati osobama mlaĎim od 18 godina u liječenju bipolarnog

poremećaja. Lijekovi za liječenje depresije i drugih mentalnih zdravstvenih problema

povećavaju rizik od suicidalnih misli i ponašanja u djece i adolescenata mlaĎih od 18 godina.

Drugi lijekovi i Lamal

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

koje druge lijekove.

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Vaš liječnik treba znati ako uzimate druge lijekove za liječenje epilepsije ili poremećaja mentalnog

zdravlja, kako bi bio siguran da uzimate odgovarajuću dozu Lamala.

Ovi lijekovi uključuju:

okskarbazepin, felbamat, gabapentin, levetiracetam, pregabalin, topiramat ili zonisamid,

koji se primjenjuju u liječenju epilepsije;

litij, olanzapin ili aripiprazol, koji se primjenjuju u liječenju poremećaja mentalnog zdravlja;

bupropion, koji se primjenjuje u liječenju poremećaja mentalnog zdravlja ili za odvikavanje

od pušenja.

Obavijestite Vašeg liječnika ako uzimate neke od spomenutih lijekova.

Pojedini lijekovi stupaju u meĎudjelovanje s Lamalom ili povećavaju učestalost nuspojava, što

uključuje:

valproat, koji se primjenjuje u liječenju epilepsije i poremećaja mentalnog zdravlja;

karbamazepin, koji se primjenjuje u liječenju epilepsije i poremećaja mentalnog zdravlja;

fenitoin, primidon ili fenobarbiton, koji se primjenjuju u liječenju epilepsije;

risperidon, koji se primjenjuje u liječenju poremećaja mentalnog zdravlja;

rifampicin, koji je antibiotik;

lijekove za liječenje HIV infekcije (kombinacija lopinavira i ritonavira ili kombinacija

atazanavira i ritonavira);

hormonske kontraceptive, kao sto su kontracepcijske pilule (vidjeti niže u tekstu).

Obavijestite Vašeg liječnika, ako uzimate neke od spomenutih lijekova, ili ako počinjete ili

prekidate s njihovom primjenom.

Hormonski kontraceptivi (kao što je kontracepcijska pilula) mogu utjecati na način kako djeluje

Lamal.

Vaš liječnik može preporučiti primjenu odreĎenog tipa hormonskih kontraceptiva ili drugu metodu

kontracepcije, kao sto su kondomi, dijafragma ili spirala. Ako primjenjujete hormonske kontraceptive

kao što je kontracepcijska pilula, Vaš liječnik može dati uzorke Vaše krvi na provjeru razine Lamala u

krvi. Ako primjenjujete hormonske kontraceptive ili ako ih planirate primjenjivati:

Obavijestite Vašeg liječnika, koji će s Vama razmotriti odgovarajuće metode kontracepcije.

Lamal takoĎer može utjecati na način na koji djeluju hormonski kontraceptivi, iako nije vjerojatno da

će smanjiti njihovu djelotvornost. Ako primjenjujete hormonske kontraceptive te primijetite odreĎene

promjene u menstrualnom ciklusu, kao što je "probojno" krvarenje ili oskudno krvarenje izmeĎu

ciklusa:

Obavijestite Vašeg liječnika. Ovo mogu biti znakovi da Lamal utječe na način kako djeluju

kontraceptivi koje primjenjujete.

Trudnoća, dojenje i plodnost

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

savjet prije nego uzmete ovaj lijek.

Moguć je blago povećani rizik od uroĎenih oštećenja u novoroĎenčadi, uključujući rascjep usne ili

rascjep nepca ako se Lamal uzimao tijekom prva 3 mjeseca trudnoće. Liječnik Vam može savjetovati

uzimanje folatne kiseline ako planirate trudnoću i tijekom trudnoće. Trudnoća takoĎer može

promijeniti učinkovitost Lamala, ali Vaš liječnik može laboratorijski provjeriti razinu lamotrigina u

Vašoj krvi i prema tome prilagoditi Vašu dozu.

Ako ste trudni, mislite da biste mogli biti trudni ili planirate trudnoću, a već uzimate Lamal,

obratite se Vašem liječniku ili ljekarniku za savjet. Ne smijete prekinuti s terapijom bez da se o

tome posavjetujete s Vašem liječnikom. To je posebno važno ako imate epilepsiju.

Posavjetujte se s Vašim liječnikom ako dojite ili planirate dojiti. Djelatna tvar Lamala prolazi u

majčino mlijeko te može utjecati na Vaše dijete. Liječnik će s Vama razgovarati o rizicima liječenja te

pozitivnim učincima dojenja dok uzimate Lamal, te će s vremena na vrijeme kontrolirati Vaše dijete

ako odlučite dojiti.

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Upravljanje vozilima i strojevima

Lamal može uzrokovati omaglicu i dvoslike.

Ne upravljajte vozilima ili strojevima, osim ako niste sigurni da lijek nema utjecaj na Vas.

Ako imate epilepsiju, posavjetujte se s liječnikom u vezi upravljanja vozilima i strojevima.

3.

Kako uzimati Lamal?

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

liječnikom ili ljekarnikom ako niste sigurni.

Koliko lijeka Lamal uzeti?

Možda će biti potrebno neko vrijeme dok se ne utvrdi odgovarajuća doza Lamala za Vas. Doza koju

uzimate će ovisiti o:

Vašoj dobi

tome uzimate li Lamal istovremeno s drugim lijekovima

tome imate li problema s bubrezima ili jetrom.

Vaš liječnik će Vam propisati nisku dozu za početak te će postupno povećavati dozu tijekom nekoliko

tjedana, sve dok se ne postigne doza koja je djelotvorna za Vas (naziva se učinkovitom dozom).

Nikada ne uzimajte više Lamala od onoga što Vam je liječnik propisao.

Uobičajena učinkovita doza Lamala za odrasle i djecu od 13 ili više godina je izmeĎu 100 mg i 400

mg svaki dan.

Za djecu od 2 do 12 godina, učinkovita doza ovisi o njihovoj tjelesnoj težini - obično je izmeĎu 1 mg i

15 mg za svaki kilogram djetetove težine, do maksimalno 200 mg odnosno 400 mg dnevno. ovisno o

tome uzima li dijete Lamal istodobno s nekim drugim lijekom ili ne

Lamal se ne preporučuje za djecu ispod 2 godine starosti.

Kako uzimati Vašu dozu Lamala?

Uzmite Vašu dozu lijeka Lamal jednom ili dva puta dnevno, onako kako Vam je savjetovao liječnik.

Lijek se može uzimati s hranom ili bez nje.

Liječnik Vam takoĎer može savjetovati da počnete ili prekinete s primjenom drugih lijekova, ovisno o

stanju zbog kojeg se liječite i načinu kako reagirate na liječenje.

Progutajte Vaše tablete cijele. Nemojte ih lomiti, žvakati ili drobiti.

Uvijek uzimajte punu dozu koju Vam je propisao liječnik. Nikada ne uzimajte samo dio

tablete.

Urez nije namijenjen za lomljenje tablete.

Ako uzmete više Lamala nego što ste trebali

Odmah se javite liječniku ili odjelu hitne službe u najbližoj bolnici. Ako je moguće, pokažite

pakiranje Lamal tableta.

Ako ste uzeli previše lijeka Lamal izgledna je pojava ozbiljnih nuspojava koje mogu biti fatalne.

Osoba koja je uzela previše Lamal tableta može imati neke od sljedećih simptoma:

brze, nekontrolirane pokrete oka (nistagmus);

nespretnost i nedostatak koordinacije, koji utječu na ravnotežu (ataksija);

promjene srčanog ritma (obično vidljive na EKG-u);

gubitak svijesti, napadaje (konvulzije) ili komu.

Potražite savjet liječnika kako ponovno započeti s liječenjem. Važno je da to napravite.

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Ako ste zaboravili uzeti Lamal

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu. Samo uzmite Vašu

sljedeću dozu u uobičajeno vrijeme.

U slučaju da ste zaboravili uzeti višestruke doze lijeka Lamal:

Posavjetujte se s Vašim liječnikom kako početi s ponovnim uzimanjem. Važno je to učiniti.

Ako prestanete uzimati Lamal

Ne prekidajte s primjenom Lamal tableta bez savjeta.

Lamal se primjenjuje toliko dugo koliko to Vaš liječnik preporučuje. Ne prekidajte s primjenom

Lamala, osim ako Vam liječnik tako ne savjetuje.

Ako uzimate Lamal za epilepsiju

Kada prestajete s uzimanjem Lamala, važno je da se doza postupno smanjuje, kroz otprilike 2

tjedna. Ako naglo prekinete primjenu Lamala, epilepsija Vam se može vratiti ili pogoršati.

Ako uzimate Lamal za bipolarni poremećaj

Potrebno je odreĎeno vrijeme kako bi Lamal počeo djelovati, tako da se vjerojatno nećete odmah

početi osjećati bolje. Kada prestajete s primjenom Lamala, nije potrebno postupno smanjivati dozu.

Ipak, potražite prvo savjet Vašeg liječnika ako želite prekinuti uzimanje Lamala.

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.

Reakcije potencijalno opasne po život: odmah potražite liječničku pomoć

Mali broj ljudi koji uzimaju Lamal dobije alergijsku reakciju ili reakcije na koži potencijalno opasne

po život, koje se mogu razviti u ozbiljnije stanje ako se ne liječe.

Veća je vjerojatnost da će se ovi simptomi pojaviti tijekom prvih nekoliko mjeseci liječenja Lamalom,

osobito ako je početna doza previsoka ili se doza prebrzo povisi, ili ako se Lamal uzima s drugim

lijekom koji se zove valproat. Neki simptomi su češći u djece, pa ih roditelji moraju pažljivo nadzirati.

Simptomi ovih reakcija uključuju:

osip ili crvenilo na koži, koji se mogu razviti u teške, po život opasne kožne reakcije uključujući

rasprostranjeni osip s mjehurima i ljuštenjem kože, osobito oko usta, nosa, očiju i genitalija

(Stevens-Johnsonov sindrom), opsežno ljuštenje kože (više od 30% površine tijela- toksična

epidermalna nekroliza) ili rasprostranjeni osip praćen poremećajima krvi, jetre i drugih organa

(reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS sindrom preosjetljivosti);

ulceracije u ustima, grlu, nosu ili genitalijama;

bolnost sluznice usne šupljine ili crvene ili natečene oči (konjunktivitis);

visoku tjelesnu temperaturu (vrućicu), simptome slične gripi ili omamljenost;

oticanje lica ili natečene žlijezde, na vratu, ispod pazuha ili u preponama;

neočekivano krvarenje ili modrice, ili prste koji plave;

grlobolju, ili češće infekcije (poput prehlade) nego što je uobičajeno;

povišene razine jetrenih enzima u krvi;

povećani broj odreĎene vrste bijelih krvnih stanica (eozinofila);

povećane limfne čvorove;

zahvaćenost drugih organa uključujući jetru i bubrege.

U mnogim slučajevima ovi simptomi će biti znaci manje ozbiljnih nuspojava. Ali Vi morate biti

svjesni da su potencijalno ozbiljne i da se mogu razviti u ozbiljnije stanje, kao što je zatajivanje

organa, ako se ne liječe. Ako primijetite neki od ovih simptoma:

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Odmah se javite liječniku. Vaš liječnik može odlučiti napraviti pretrage jetre, bubrega ili krvi te

može odlučiti da prekinete uzimanje Lamala. U slučaju da razvijete Stevens-Johnsonov sindrom,

toksičnu epidermalnu nekrolizu ili reakciju na lijek s eozinofilijom i sistemskim simptomima, Vaš će

Vam liječnik reći da više nikada ne smijete koristiti lamotrigin.

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

glavobolja;

osip na koži.

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

agresija ili razdražljivost;

osjećaj pospanosti ili omamljenosti;

osjećaj omaglice;

tresenje ili nevoljno drhtanje (tremor);

problemi sa spavanjem (nesanica);

osjećaj uznemirenosti;

osjećaj mučnine, povraćanje, proljev;

suhoća usta;

osjećaj umora;

bolovi u leĎima ili zglobovima, ili drugdje.

Manje česte nuspojave (mogu se javiti u manje od 100 osoba):

• nespretnost i nedostatak koordinacije (ataksija);

• dvoslike ili zamućen vid.

• neuobičajeno ispadanje ili prorjeĎivanje kose (alopecija)

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

• po život opasne reakcije na koži (Stevens-Johnsonov sindrom) (vidjeti također informacije na

početku dijela 4.)

skupina zajedničkih simptoma koji uključuju: vrućicu, mučninu, povraćanje, glavobolju, ukočeni

vrat i izraženu osjetljivost na jaku svjetlost. To može biti uzrokovano upalom membrana koje

pokrivaju mozak i leĎnu moždinu (meningitis). Ovi simptomi se obično povlače nakon prekida

liječenja, ipak u slučaju da se nastave ili pogoršaju, obratite se Vašem liječniku;

brzi, nekontrolirani pokreti oka (nistagmus).

svrbež očiju, s iscjetkom ili sasušenim sekretom na kapcima (konjunktivitis);

Vrlo rijetke nuspojave (mogu se javiti u manje od 1 na 10 000 osoba):

• po život opasne reakcije na koži (toksična epidermalna nekroliza) (vidjeti također informacije na

početku dijela 4.)

• reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS) (vidjeti također informacije

na početku dijela 4.)

visoka tjelesna temperatura (vrućica) (vidjeti također informacije na početku dijela 4.);

oticanje lica (edem) ili natečene žlijezde, na vratu, ispod pazuha ili u preponama

(limfadenopatija) (vidjeti također informacije na početku dijela 4.);

promjene u funkciji jetre koje će se pokazati u nalazima krvi, ili zatajenje jetre (vidjeti također

informacije na početku dijela 4.);

teški poremećaj zgrušavanja krvi, što može dovesti do neočekivanog krvarenja ili pojave

modrica (diseminirana intravaskularna koagulacija) (vidjeti također informacije na početku dijela

4.);

promjene koje se mogu pojaviti u nalazima krvi — uključujući smanjeni broj crvenih krvnih

stanica (anemija), smanjen broj bijelih krvnih stanica (leukopenija, neutropenija, agranulocitoza),

smanjeni broj trombocita (trombocitopenija), smanjen broj svih ovih tipova stanica

(pancitopenija), te poremećaj koštane srži koji se naziva aplastična anemija;

halucinacije (vide se ili čuju stvari koje nisu realne);

smetenost;

osjećaj nesigurnosti ili nestabilnosti prilikom kretanja;

nekontrolirani tjelesni pokreti (tikovi), nekontrolirani mišićni grčevi koji zahvaćaju oči, glavu i

H A L M E D

16 - 11 - 2017

O D O B R E N O

gornji dio trupa (koreoatetoza), ili drugi neuobičajeni tjelesni pokreti kao sto su trzanje, tresenje ili

ukočenost;

kod osoba koje već imaju epilepsiju češći napadaji;

u osoba koje već imaju Parkinsonovu bolest, pogoršanje simptoma te bolesti;

reakcija slična lupusu (simptomi mogu uključivati: bol u leĎima ili zglobovima koji ponekad mogu

biti popraćeni vrućicom i/ili općim lošim osjećanjem).

Nuspojave nepoznate učestalosti

Ostale nuspojave javile su se kod malog broja ljudi, ali njihova točna učestalost ne može se procijeniti

iz dostupnih podataka:

• prijavljeni su slučajevi poremećaja kostiju uključujući osteopeniju i osteoporozu (smanjenje

gustoće kostiju) te prijelome. Provjerite s Vašim liječnikom ili ljekarnikom ako se dugotrajno

liječite lijekovima za liječene epilepsije, ako imate osteoporozu ili uzimate steroide;

• noćne more

Prijavljivanje nuspojava

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

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti

izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Lamal?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

''EXP''. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

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 Lamal sadrži?

Djelatna tvar je lamotrigin.

Jedna tableta sadrži 25 mg, 50 mg, 100 mg ili 200 mg lamotrigina.

Drugi sastojci su: kalcijev karbonat, aluminijev magnezijev silikat, natrijev škroboglikolat,

niskosupstituirana hidroksipropilceluloza, povidon, mikrokristalična celuloza, saharinnatrij,

aroma crnog ribizla, bezvodni koloidni silicijev dioksid, magnezijev stearat.

Kako Lamal izgleda i sadržaj pakiranja?

Lamal 25 mg tablete

Bijele, okrugle, bikonveksne tablete, promjera približno 6 mm.

30 (3x10) tableta u PVC/Al blisteru, u kutiji.

60 (6x10) tableta u PVC/Al blisteru, u kutiji.

Lamal 50 mg tablete

Bijele, okrugle, bikonveksne tablete promjera približno 8 mm s urezom na jednoj strani. Urez nije

namijenjen za lomljenje tablete.

30 (3x10) tableta u PVC/Al blisteru, u kutiji.

60 (6x10) tableta u PVC/Al blisteru, u kutiji.

Lamal 100 mg tablete

Bijele, okrugle, bikonveksne tablete promjera približno 10 mm s urezom na jednoj strani. Urez nije

namijenjen za lomljenje tablete.

H A L M E D

16 - 11 - 2017

O D O B R E N O

30 (2x15) tableta u PVC/Al blisteru, u kutiji.

60 (4x15) tableta u PVC/Al blisteru, u kutiji.

Lamal 200 mg tablete

Bijele, okrugle, bikonveksne tablete promjera približno 11 mm s urezom na jednoj strani. Urez nije

namijenjen za lomljenje tablete.

30 (2x15) tableta u PVC/Al blisteru, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja:

Alkaloid d.o.o.

Ulica grada Vukovara 226 F

10 000 Zagreb

Tel: +385 1 63 11 920

Fax: +385 1 63 11 922

e-mail: alkaloid@alkaloid.hr

ProizvoĎač:

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana – Črnuče, Slovenija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u studenom 2017.

H A L M E D

16 - 11 - 2017

O D O B R E N O

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen 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 validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

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

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

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

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

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

23-10-2018

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

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

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

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

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

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

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

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

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

18-9-2018

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

The hair dryer and power cord can overheat and catch on fire, posing fire, burn and electrical shock hazards.

Health Canada

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

5-9-2018

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Published on: Tue, 04 Sep 2018 00:00:00 +0200 This technical report reflects the outcome of the mammalian toxicology experts meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No 1107/2009. The main issues identified were related to genotoxicity of products and principles of (Q)SAR and read‐across. General presentations on the different EFSA guidance and EFSA developmental activities related to human health risk assessment of pesti...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency