Bonefurbit

Glavne informacije

  • Zaščiteno ime:
  • Bonefurbit 150 mg filmsko obložene tablete
  • Farmacevtska oblika:
  • filmsko obložena tableta
  • Sestava:
  • ibandronska kislina 150 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 3 tabletami (1 x 3 tablete v pretisnem omotu)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Bonefurbit 150 mg filmsko obložene tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • ibandronska kislina

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 103-138/2015-3
  • Datum dovoljenje:
  • 29-03-2017
  • EAN koda:
  • 3837000128246
  • Zadnja posodobitev:
  • 25-05-2018

Podatki za bolnike

JAZMP‐IB/003/G‐14.07.2014

Bonefurbit

150 mg filmsko obložene

tablete

ibandronska

kislina

Pred začetkom jemanja

zdravila

natančno preberite navodilo

, ker vsebuje za vas pomembne

podatke

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali farmacevtom.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo

škodovalo, čeprav imajo znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.

Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem

navodilu.

Kaj

vsebuje

navodilo

Kaj je zdravilo Bonefurbit in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Bonefurbit

Kako jemati zdravilo Bonefurbit

Možni neželeni učinki

Shranjevanje zdravila Bonefurbit

Vsebina pakiranja in dodatne informacije

Kaj je zdravilo Bonefurbit in za kaj ga uporabljamo

Bonefurbit spada v skupino zdravil, ki jih imenujemo difosfonati. Vsebuje zdravilno

učinkovino ibandronsko kislino.

Zdravilo Bonefurbit zavre izgubo kostne mase tako, da zaustavi njeno nadaljnjo izgubo. S tem kostno

maso poveča pri večini bolnic, ki ga jemljejo, čeprav same ne bodo videle ali čutile razlike. Zdravilo

Bonefurbit pomaga zmanjšati možnost zloma. Zmanjšanje zlomov je bilo dokazano za hrbtenico, ne

pa za kolke.

Zdravilo Bonefurbit vam je zdravnik predpisal za zdravljenje pomenopavzne osteoporoze, ker

imate povečano tveganje za zlome.

Osteoporoza je bolezen, zaradi katere postanejo kosti tanjše in

šibkejše, kar se najpogosteje pojavlja pri ženskah po menopavzi. V menopavzi jajčniki prenehajo

proizvajati ženski hormon estrogen, ki ženskam pomaga ohranjati zdravo okostje.

Prej ko nastopi menopavza, večje je tveganje za zlome pri osteoporozi. Drugi dejavniki, ki lahko

povečajo tveganje za zlome, so:

premajhen vnos kalcija in vitamina D s hrano,

kajenje ali čezmerno pitje alkohola,

pomanjkanje hoje ali drugih telesnih aktivnosti,

družinska obremenjenost z osteoporozo.

Zdrav način življenja

vam bo prav tako pomagal, da bo vaše zdravljenje čimbolj uspešno. To

vključuje

uravnoteženo prehrano, bogato s kalcijem in vitaminom D, hojo ali druge telesne

aktivnosti z vplivom na telesno maso, opustitev kajenja in zmerno pitje alkohola.

uravnoteženo prehrano, bogato s kalcijem in vitaminom D,

hojo ali druge telesne aktivnosti z vplivom na telesno maso,

opustitev kajenja in zmerno pitje alkohola.

JAZMP‐IB/003/G‐14.07.2014

2.

Kaj morate vedeti, preden boste vzeli zdravilo Bonefurbit

Ne jemljite zdravila Bonefurbit

Če ste alergični na ibandronsko kislino ali katero koli sestavino tega zdravila (navedeno v

poglavju 6).

Če imate določene težave s požiralnikom, kot je zožitev ali težave s požiranjem.

Če ne morete stati ali pokončno sedeti vsaj eno uro (60 minut) skupaj.

Če imate znižano koncentracijo kalcija v krvi, ali ste jo imeli v preteklosti.

Prosimo,

posvetujte se z zdravnikom.

Opozorila in previdnostni ukrepi

Nekateri ljudje morajo biti pri jemanju zdravila Bonefurbit še posebno previdni. Pred začetkom

jemanja zdravila Bonefurbit se posvetujte s svojim zdravnikom:

če imate kakršnekoli motnje presnove mineralov (kot je pomanjkanje vitamina D),

če vaše ledvice ne delujejo normalno,

če imate težave s požiranjem ali prebavo.

Pred zdravljenjem ali operacijo zob povejte svojemu zobozdravniku, da se zdravite z zdravilom

Bonefurbit. Zobozdravniku povejte tudi, če imate raka.

Lahko pride do draženja, vnetja ali razjede požiralnika, pogosto s simptomi, kot so huda bolečina v

prsih, huda bolečina pri požiranju hrane in/ali pitju pijače, huda slabost ali bruhanje, še posebej, če ne

popijete polnega kozarca vode in/ali če se uležete prej kot v eni uri po zaužitju zdravila Bonefurbit. Če

se pri vas pojavijo ti simptomi, prenehajte jemati zdravilo Bonefurbit in takoj obvestite svojega

zdravnika (glejte poglavje 3).

Otroci in mladostniki

Zdravila Bonefurbit ne dajajte otrokom in mladostnikom, mlajšim od 18 let.

Druga zdravila in zdravilo Bonefurbit

Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda

začeli jemati katero koli drugo zdravilo. Še posebno:

-

Dodatke, ki vsebujejo kalcij, magnezij, železo ali aluminij, ker imajo lahko vpliv na

delovanje zdravila Bonefurbit.

-

Acetilsalicilno kislino in druga nesteroidna protivnetna zdravila (NSAID, ki vključujejo

ibuprofen, natrijev diklofenak in naproksen) lahko dražijo želodec in črevesje. Difosfonati (kot

zdravilo Bonefurbit) imajo lahko enak učinek. Če jemljete zdravila proti bolečini ali protivnetna

zdravila med zdravljenjem z zdravilom Bonefurbit, bodite še posebno previdni.

Vsak mesec, ko pogoltnete tableto zdravila Bonefurbit,

počakajte 1 uro preden zaužijete

katerokoli drugo zdravilo

, vključno z zdravili proti slabi prebavi, kalcijevimi dodatki ali vitamini.

Zdravilo Bonefurbit skupaj s hrano in pijačo

Ne jemljite zdravila Bonefurbit skupaj s hrano.

Zdravilo Bonefurbit je manj učinkovito, če ga

jemljete skupaj s hrano.

Lahko pijete vodo, drugih pijač pa ne

(glejte poglavje 3. Kako jemati

zdravilo Bonefurbit).

Nosečnost in dojenje

Zdravilo Bonefurbit se uporablja samo pri ženskah po menopavzi, ženske, ki še lahko imajo otroka, pa

ga ne smejo jemati.

Ne jemljite zdravila Bonefurbit, če ste noseči ali dojite.

Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete to zdravilo.

Vpliv na sposobnost upravljanja vozil in strojev

Lahko vozite in upravljate s stroji, ker pričakujemo, da zdravilo Bonefurbit nima ali ima

zanemarljiv učinek na vašo sposobnost za vožnjo in upravljanje s stroji.

JAZMP‐IB/003/G‐14.07.2014

Zdravilo Bonefurbit vsebuje laktozo.

Če vam je zdravnik povedal, da ne prenašate ali prebavljate

nekaterih sladkorjev (npr. ne prenašate galaktoze, imate laponsko obliko zmanjšane aktivnosti laktaze

ali malabsorpcijo glukoze/galaktoze), se z njim posvetujte, preden vzamete to zdravilo.

3.

Kako jemati zdravilo Bonefurbit

Pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika. Če ste negotovi, se

posvetujte s svojim zdravnikom ali farmacevtom.

Obi

č

ajen odmerek zdravila Bonefurbit je ena tableta enkrat na

mesec.

Mesečno jemanje vaše tablete

Zelo pomembno je, da natančno upoštevate ta navodila. Pripravljena so vam v pomoč, da bo tableta

zdravila Bonefurbit laže hitro prišla v želodec in bo možnost draženja manjša.

Vzemite eno tableto Bonefurbit 150 mg enkrat na mesec.

Izberite si dan v mesecu

, ki si ga boste lahko zapomnili. Lahko izberete ali isti datum (npr. 1. v

mesecu) ali isti dan (npr. prvo nedeljo v mesecu) za jemanje tablet zdravila Bonefurbit.

Izberite

dan,

ki najbolje ustreza vaši rutini.

Vzemite tableto zdravila Bonefurbit

vsaj 6 ur po tem, ko ste zadnjič karkoli

pojedli ali

pili karkoli razen vode.

Vzemite tableto zdravila Bonefurbit

ko zjutraj vstanete

preden karkoli pojeste ali popijete

(na prazen želodec).

Tableto pogoltnite s polnim kozarcem vode

(ne manj kot 180 ml).

Tablete

ne

vzemite z vodo z visoko vsebnostjo kalcija, sadnim sokom ali katerokoli drugo pijačo. Če

obstaja skrb, da je v vodi iz pipe visok delež kalcija (trda voda), je priporočljivo uporabljati

ustekleničeno vodo z nizko vsebnostjo mineralov.

Tableto pogoltnite celo -

ne žvečite in ne prelamljajte tablete ter ne pustite, da se raztopi v

ustih.

Naslednjo uro (60 minut)

potem, ko ste vzeli svojo tableto:

se ne ulezite

; če ne ostanete v pokončnem položaju (stoje ali sede), lahko nekaj zdravila

zaide nazaj v vaš požiralnik;

ničesar ne jejte

ničesar ne pijte

(razen vode, če jo potrebujete);

ne jemljite drugih zdravil.

Potem, ko ste počakali eno uro, lahko zaužijete svoj prvi dnevni obrok. Ko ste se najedli, se

lahko uležete, če želite, in vzamete druga zdravila, ki jih potrebujete.

JAZMP‐IB/003/G‐14.07.2014

Tablet

ne

jemljite zvečer ali preden zjutraj vstanete.

Nadaljevanje jemanja zdravila Bonefurbit

Pomembno je, da vzamete zdravilo Bonerfurbit vsak mesec, dokler vam ga je predpisal

zdravnik. Po petih letih uporabe zdravila Bonefurbit se prosimo posvetujte z zdravnikom glede

nadaljevanja jemanja zdravila Bonefurbit. Zdravilo Bonefurbit lahko zdravi osteoporozo le,

dokler ga jemljete.

Če ste vzeli večji odmerek zdravila Bonefurbit, kot bi smeli

Če ste po pomoti vzeli več kot eno tableto,

popijte poln kozarec mleka in se takoj posvetujte s

svojim zdravnikom.

Ne izzovite bruhanja in ne lezite

– tako bi lahko zdravilo Bonefurbit dražilo vaš požiralnik.

Če ste pozabili vzeti zdravilo Bonefurbit

Če ste pozabili vzeti tableto na jutro izbranega dne,

ne vzemite tablete pozneje v istem dnevu

Namesto tega poglejte v vaš koledar, kdaj je naslednji načrtovani odmerek:

Če je do vašega načrtovanega odmerka le 1 do 7 dni…

počakajte do naslednjega načrtovanega odmerka in ga vzemite kot običajno, nato jemanje tablet

nadaljujte enkrat na mesec, na izbrane dni, ki ste si jih označili na koledarju.

Če je vaš načrtovani odmerek čez več kot 7 dni…

vzemite eno tableto naslednje jutro potem, ko se spomnite, nato jemanje tablet nadaljujte enkrat na

mesec, na izbrane dni, ki ste si jih označili na koledarju.

Nikoli ne vzemite dveh tablet zdravila Bonefurbit v istem tednu.

Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.

Nemudoma se obrnite na medicinsko sestro ali zdravnika, če opazite katerega koli od spodaj

naštetih resnih neželenih učinkov – morda boste potrebovali nujno medicinsko pomoč:

Občasni

(pojavijo se lahko pri največ 1 od 100 bolnikov):

huda bolečina v prsnem košu, huda bolečina po požiranju hrane ali pijače, huda slabost ali

bruhanje, težave pri požiranju. Lahko imate hudo vnetje požiralnika, morda z ranami ali

zožitvijo požiralnika.

Redki

(pojavijo se lahko pri največ 1 od 1.000 bolnikov):

srbenje, otekanje obraza, ustnic, jezika in žrela s težkim dihanjem,

vztrajna bolečina in vnetje oči,

na novo nastala bolečina, oslabelost ali neugodje v stegnih, kolku ali dimljah. Lahko imate

zgodnje znake možnega neobičajnega zloma stegnenice.

Zelo

redki

(

pojavijo se

lahko pri največ 1 od 10.000 bolnikov):

bolečina ali rana v vaših ustih ali čeljusti. Lahko imate zgodnje znake resnih težav s čeljustmi

(nekrozo (mrtvo kostno tkivo) v

čeljustnicah);

resna, možno življenjsko ogrožujoča alergična reakcija.

JAZMP‐IB/003/G‐14.07.2014

Drugi možni neželeni učinki

Pogosti

(pojavijo se lahko pri največ 1 od 10 bolnikov):

glavobol,

zgaga, neugodje pri požiranju, bolečina v želodcu ali trebuhu (lahko zaradi vnetja

želodca), slaba prebava, slabost, driska,

mišični krči, togost v sklepih ali okončinah.

simptomi, podobni gripi, vključno s povišano telesno temperaturo, drgetanjem in mrazenjem,

občutjem neugodja, utrujenostjo, bolečino v kosteh in bolečimi mišicami ter sklepi.

Obrnite sena medicinsko sestro ali zdravnika, če simptomi postanejo moteči ali trajajo

več kot nekaj dni;

izpuščaj

Občasni

(pojavijo se lahko pri največ 1 od 100 bolnikov):

omotica,

napenjanje (vetrovi, občutek napihnjenosti),

bolečina v hrbtu,

občutek utrujenosti in izčrpanosti.

Redki

(pojavijo se lahko pri največ 1 od 1.000 bolnikov):

vnetje dvanajstnika (začetnega dela črevesa), ki povzroča bolečino v trebuhu,

koprivnica.

Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.

Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu.

Shranjevanje zdravila Bonefurbit

Zdravilo shranjujte nedosegljivo otrokom!

Za shranjevanje zdravila niso potrebna posebna navodila.

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli

poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega

meseca.

Za shranjevanje zdravila niso potrebna posebna navodila.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu odstranjevanja

zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom. Taki ukrepi pomagajo varovati

okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Bonefurbit

Zdravilna učinkovina je ibandronska kislina. Ena tableta vsebuje 150 mg ibandronske kisline

(v obliki natrijevega ibandronata monohidrata).

Pomožne snovi so:

jedro tablete

: laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat,

magnezijev stearat in brezvodni koloidni silicijev dioksid;

obloga tablete

: hidroksipropilceluloza , titanov dioksid (E 171) in makrogol 6000.

JAZMP‐IB/003/G‐14.07.2014

Izgled zdravila Bonefurbit in vsebina pakiranja

Bonefurbit 150 mg filmsko obložene tablete so bele filmsko obložene tablete podolgovate oblike z

oznako LC na eni strani.

Bonefurbit 150 mg filmsko obložene tablete so na voljo v velikostih pakiranja po 1 in 3 filmsko

obložene tablete. Tablete so na voljo v pretisnih omotih po 1 ali 3 tablete.

Na trgu ni vseh navedenih pakiranj.

Način in režim izdaje zdravila

Predpisovanje in izdaja zadravila je le na recept.

Imetnik dovoljenja za promet z zdravilom

Laboratorios Liconsa, SA

Gran Via Carlos III, 98, 7

floor

08028 Barcelona

ŠPANIJA

Izdelovalec

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), ŠPANIJA

Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:

Avstrija: Bonefurbit 150 mg Filmtabletten

Belgija: Bonefurbit 150 mg Comprimés pelliculés

Bolgarija: Bonefurbit 150 mg Филмирана таблетка

Češka: Flastin 150 mg potahované tablety

Danska: Bonefurbit 150 mg Filmovertrukket tablet

Estonija: Bonefurbit 150 mg

Finska: Bonefurbit 150 mg Tabletti, kalvopäällysteinen

Francija: Bonefurbit 150 mg Comprimés pelliculés

Nemčija: Bonefurbit 150 mg Filmtabletten

Grčija: Bonefurbit 150 mg Επικαλυμμένο με λεπτό υμένιο δισκίο

Madžarska: Bonefurbit 150 mg Filmtabletta

Irska: Bonefurbit 150 mg Film-coated tablets

Italija: Bonefurbit 150 mg Compressa rivestita con film

Latvija: Bonefurbit 150 mg Apvalkotās tabletes

Litva: Bonefurbit 150 mg Plėvele dengtos tabletės

Luksemburg: Bonefurbit 150 mg Comprimés pelliculés

Nizozemska: Bonefurbit 150 mg Filmomhulde tabletten

Norveška: Bonefurbit 150 mg Tablett, filmdrasjert

Poljska: Bonefurbit

Portugalska: Bonefurbit 150 mg

Slovaška: Flastin 150 mg

Slovenija: Bonefurbit 150 mg filmsko obložene tablete

Velika Britanija: Bonefurbit 150 mg Film-coated tablets

Navodilo je bilo odobreno 14. 7. 2014.

19-11-2018

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Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

15-10-2018

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Health Canada has determined that the slime and putty products do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

15-10-2018

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Health Canada's sampling and evaluation program has determined the Barrel-O-Slime toy does not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

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

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Health Canada's sampling and evaluation program has determined the Super Cool Slime products donot meet the Canadian toy safety requirements related to boric acid content.

Health Canada

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

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

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

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

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

3-7-2018

Granupas (Eurocept International B.V.)

Granupas (Eurocept International B.V.)

Granupas (Active substance: Para-aminosalicylic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4256 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2709/T/25

Europe -DG Health and Food Safety

27-6-2018

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Active substance: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid) - Transfer of orphan designation - Commission Decision (2018)4102 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/10/T/02

Europe -DG Health and Food Safety

19-6-2018

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Active substance: oxalic acid dihydrate) - Centralised - Authorisation - Commission Decision (2018)3892 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4667

Europe -DG Health and Food Safety

4-6-2018

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Active substance: chenodeoxycholic acid) - Centralised - Yearly update - Commission Decision (2018)3627 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety