Actonel

Glavne informacije

  • Zaščiteno ime:
  • Actonel 75 mg filmsko obložene tablete
  • Farmacevtska oblika:
  • filmsko obložena tableta
  • Sestava:
  • risedronska kislina 69,6 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 6 tabletami (3 x 2 tableti 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:
  • Actonel 75 mg filmsko obložene tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • risedronska 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:
  • 103-141/2014-2
  • Datum dovoljenje:
  • 26-11-2014
  • EAN koda:
  • 3837000110630
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

SE/H/0192/IB/109/G_v1.0

JAZMP-IB/109/G-16.5.2017

Navodilo za uporabo

Actonel 75 mg filmsko obložene tablete

natrijev risedronat

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 z zdravnikom ali s 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 s farmacevtom.

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

Glejte poglavje 4.

Kaj vsebuje navodilo:

Kaj je zdravilo Actonel in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Actonel

Kako jemati zdravilo Actonel

Možni neželeni učinki

Shranjevanje zdravila Actonel

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Actonel in za kaj ga uporabljamo

Kaj je zdravilo Actonel

Zdravilo Actonel spada v skupino bisfosfonatov, nehormonskih zdravil, ki jih uporabljamo za

zdravljenje bolezni kosti. Deluje neposredno na kosti, jih krepi in tako zmanjšuje verjetnost zlomov.

Kost je živo tkivo. Stara kostnina se iz okostja nenehno odstranjuje in nadomešča jo nova.

Pomenopavzna osteoporoza je stanje, ki se pojavi pri ženskah po menopavzi in povzroči, da kosti

postanejo šibkejše, bolj krhke in se ob padcu ali obremenitvi hitreje zlomijo.

Najpogostejši so zlomi hrbtenice, kolka in zapestja, vendar se lahko zlomi tudi katerakoli druga kost v

telesu. Z osteoporozo povezani zlomi lahko povzročijo tudi bolečine v hrbtu, zmanjšanje telesne višine

in ukrivljenost hrbtenice. Številne bolnice z osteoporozo nimajo nobenih simptomov in možno je, da

sploh niste vedeli, da jo imate.

Za kaj uporabljamo zdravilo Actonel

Zdravljenje osteoporoze pri

ženskah po menopavzi.

2.

Kaj morate vedeti, preden boste vzeli zdravilo Actonel

Ne jemljite zdravila Actonel

Če ste alergični na natrijev risedronat ali katerokoli drugo sestavino tega zdravila (navedeno v

poglavju 6).

Če vam je zdravnik povedal, da imate hipokalcemijo (nizko koncentracijo kalcija v krvi).

Če bi lahko bili noseči, ste noseči ali nameravate zanositi.

Če dojite.

Če imate hude težave z ledvicami.

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Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila Actonel se posvetujte s svojim zdravnikom ali s farmacevtom:

Če ne morete biti pokonci (sedeti ali stati) vsaj 30 minut.

Če imate moteno presnovo kosti in mineralov (npr. pomanjkanje vitamina D, nepravilnosti

obščitničnih hormonov; oboje povzroči nizko koncentracijo kalcija v krvi).

Če imate ali ste kdaj imeli težave s požiralnikom (prehodom, ki usta povezuje z želodcem).

Morda se vam pojavljajo ali so se vam pojavljale npr. bolečine ali težave pri požiranju hrane ali

vam je bilo predhodno rečeno, da imate Barrettov požiralnik (stanje, ki je povezano s

spremembami celic v spodnjem delu požiralnika).

Če imate ali ste kdaj imeli bolečo, oteklo ali omrtvelo čeljust, občutek “težke čeljusti” ali

razmajanost zoba.

Če se trenutno zdravite pri zobozdravniku ali imate predviden kirurški poseg v ustni votlini,

morate zobozdravniku povedati, da jemljete zdravilo Actonel.

Če imate kaj od naštetega, vam bo zdravnik svetoval, kaj storiti pri jemanju zdravila Actonel.

Otroci in mladostniki

Natrijevega risedronata ni priporočljivo uporabljati pri otrocih, mlajših od 18 let, ker o njegovi

varnosti in učinkovitosti ni dovolj podatkov.

Druga zdravila in zdravilo Actonel

Učinek zdravila Actonel se lahko zmanjša pri sočasnem jemanju zdravil, ki vsebujejo katero od

naslednjih snovi:

kalcij,

magnezij,

aluminij (npr. v nekaterih pripravkih proti prebavnim težavam),

železo.

Takšna zdravila vzemite najmanj 30 minut po zaužitju tablete Actonel.

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

začeli jemati katerokoli zdravilo.

Zdravilo Actonel skupaj s hrano in pijačo

Za pravilno delovanje zdravila je zelo pomembno, da tablet Actonel NE JEMLJETE skupaj s hrano ali

pijač

o (razen navadno vodo). Tablet še posebej ne smete jemati skupaj z mlečnimi izdelki (npr. z

mlekom), ker ti izdelki vsebujejo kalcij (glejte poglavje 2, “Druga zdravila in zdravilo Actonel”).

Hrano in pijače (razen navadne vode) zaužijte vsaj 30 minut po zaužitju tablete Actonel.

Nosečnost in dojenje

NE JEMLJITE zdravila Actonel, če bi lahko bili noseči, če ste noseči ali če nameravate zanositi (glejte

poglavje 2, “Ne jemljite zdravila Actonel”). Možno tveganje, povezano z uporabo natrijevega

risedronata (zdravilne učinkovine v tabletah Actonel) pri nosečnicah, ni znano.

NE JEMLJITE zdravila Actonel, če dojite (glejte poglavje 2, “Ne jemljite zdravila Actonel”).

Tablete Actonel so namenjene le za zdravljenje žensk po menopavzi.

Vpliv na sposobnost upravljanja vozil in strojev

Ni znano, da bi zdravilo Actonel vplivalo na sposobnost upravljanja vozil in strojev.

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3.

Kako jemati zdravilo Actonel

Pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta. Če ste

negotovi, se posvetujte z zdravnikom ali s farmacevtom.

Priporočeni odmerek:

Actonel tablete morate jemati vsak mesec na ISTA dva zaporedna dneva, npr. prvega in drugega v

mesecu ali petnajstega in šestnajstega v mesecu.

Izberite DVA zaporedna datuma, ki najbolj ustrezata vašemu urniku. Na prvi dan zjutraj vzemite

PRVO tableto zdravila Actonel. Naslednji dan zjutraj vzemite DRUGO tableto zdravila Actonel.

Zdravilo jemljite vsak mesec na ista dva zaporedna dneva. Da bi si lažje zapomnili, kdaj je potrebno

zopet vzeti tableto, si lahko predhodno v vaš koledar naredite zaznamek s pisalom ali nalepko.

KDAJ vzeti tableto Actonel

Tableto Actonel vzemite vsaj 30 minut prej, preden tisti dan zaužijete prvo hrano, pijačo (razen

navadne vode) ali kakšno drugo zdravilo.

KAKO vzeti tableto Actonel

Tableto vzemite v

pokončnem položaju

(sede ali stoje), da boste preprečili težave z zgago.

Pogoltnite jo

z vsaj enim

kozarcem

(120 ml)

navadne vode

Ne zaužijte tablet z mineralno

vodo

ali s katerokoli drugo pijačo, razen z navadno vodo.

Tableto pogoltnite celo.

Ne smete jo sesati ali žvečiti.

Ne ulezite se prej kot 30 minut po

zaužitju tablete.

Če s prehrano ne zaužijete dovolj kalcija in vitaminov, vam bo zdravnik povedal, če potrebujete

dodatke kalcija in vitaminov.

Če ste vzeli večji odmerek zdravila Actonel, kot bi smeli

Če kdo (vi ali kdo drug) pomotoma vzame več tablet Actonel, kot je predpisano, naj popije poln

kozarec mleka in poišče zdravniško pomoč.

Če ste pozabili vzeti zdravilo Actonel

Če ste pozabili vzeti

Kdaj

Kaj storiti

Prvo in drugo tableto

Do naslednjega mesečnega

odmerka je več kot 7 dni

Prvo tableto vzemite naslednje jutro,

po dnevu, ko se spomnite, drugo

tableto pa zjutraj naslednjega dne

Do naslednjega mesečnega

odmerka je manj kot 7 dni

Ne vzemite pozabljenih tablet

Le drugo tableto

Do naslednjega mesečnega

odmerka je več kot 7 dni

Drugo tableto vzemite naslednje jutro

po dnevu, ko se spomnite

Do naslednjega mesečnega

odmerka je manj kot 7 dni

Ne vzemite pozabljene tablete

Naslednji mesec nadaljujte z jemanjem tablet na izbrana dneva.

V vsakem primeru:

Če ste pozabili vzeti odmerek zdravila Actonel zjutraj, ga kasneje isti dan NE SMETE vzeti.

V istem tednu NE SMETE vzeti treh tablet.

Če ste prenehali jemati zdravilo Actonel

Če zdravljenje prekinete, lahko začnete izgubljati kostno maso. Preden se odločite za prekinitev

zdravljenja, se posvetujte z zdravnikom.

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.

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4.

Možni neželeni učinki

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

Takoj prenehajte jemati zdravilo Actonel in obvestite zdravnika,

če se vam pojavi kaj od spodaj

navedenega:

Simptomi značilni za resno alergično reakcijo kot:

oteklost obraza, jezika ali žrela

težave pri požiranju

koprivnica in težave pri dihanju

Hude kožne reakcije, pri katerih se lahko pojavi mehurjenje kože.

Če se vam pojavi kateri od naslednjih neželenih učinkov,

morate to nemudoma povedati zdravniku

Vnetje očesa, ponavadi z bolečino, pordelostjo in občutljivostjo za svetlobo.

Kostna nekroza čeljustnice (osteonekroza), povezana s počasnim celjenjem ali okužbo, ki se

pogosto pojavi po izruvanju zoba (glejte poglavje 2, “Opozorila in previdnostni ukrepi”).

Simptomi iz požiralnika kot so bolečina pri požiranju, težave pri požiranju, bolečina v prsih ali

nov pojav oz. poslabšanje zgage.

Redko

lahko

pojavi

nenavaden

zlom

stegnenice,

predvsem

bolnikih

dolgotrajnem

zdravljenju za osteoporozo. Če se vam pojavijo bolečine, šibkost ali nelagodje v stegnu, kolku ali

dimljah, se morate posvetovati s svojim zdravnikom, kajti to so lahko zgodnji znaki možnega zloma

stegnenice.

Drugi neželeni učinki, ki so jih ugotovili v kliničnih študijah, so bili običajno blagi in zaradi njih

zdravljenja ni bilo treba prekiniti.

Pogosti neželeni učinki

(pojavijo se lahko pri največ 1 od 10 bolnikov)

Prebavne težave, siljenje na bruhanje, bruhanje, bolečine v trebuhu, trebušni krči ali nelagodje,

zaprtje, ob

čutek polnosti, napenjanje, driska.

Bolečine v kosteh, mišicah ali sklepih.

Glavobol.

Občasni neželeni učinki

(pojavijo se lahko pri največ 1 od 100 bolnikov)

Vnetje ali razjeda požiralnika (prehoda, ki usta povezuje z želodcem) s posledičnim težkim in

bolečim požiranjem (glejte tudi poglavje 2, “Opozorila in previdnostni ukrepi”), vnetje želodca

in dvanajstnika (del črevesa, v katerega se prazni želodec).

Vnetje obarvanega dela očesa (šarenice) (rdeče, boleče oči z možno spremembo vida).

Povišana telesna temperatura in/ali gripi podobni znaki.

Redki neželeni učinki

(pojavijo se lahko pri največ 1 od 1.000 bolnikov)

Vnetje jezika (pordel, otekel in lahko boleč), zožitev požiralnika (prehoda, ki usta povezuje z

želodcem).

Poročali so o nenormalnih izvidih jetrnih testov. Te je mogoče ugotoviti samo s preiskavo krvi.

Med pomarketinško uporabo so bile opisane naslednje dodatne neželene reakcije

Zelo redki: V primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte s

svojim zdravnikom. To so lahko znaki poškodbe kosti v ušesu.

Neznana pogostnost:

Izguba las.

Motnje v delovanju jeter, v nekaterih primerih resne.

Redko se na začetku zdravljenja znižata koncentracija kalcija in fosfatov v krvi. Te spremembe so

običajno majhne in ne povzročajo simptomov.

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Poročanje o neželenih učinkih

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. Posvetujte se tudi,

če opazite neželene učinke, ki niso navedeni v tem navodilu. O neželenih učinkih lahko poročate tudi

neposredno na Univerzitetni klinični center Ljubljana, Interna klinika, Center za zastrupitve, Zaloška

cesta 2, SI-1000 Ljubljana, Faks: + 386 (0)1 434 76 46, e-pošta: farmakovigilanca@kclj.si.

S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega

zdravila.

5.

Shranjevanje zdravila Actonel

Zdravilo shranjujte nedosegljivo otrokom!

Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem

omotu poleg oznake EXP. Datum izteka roka uporabosti 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. Takšni ukrepi pomagajo varovati

okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Actonel

Zdravilna učinkovina je natrijev risedronat. Vsaka tableta vsebuje 75 mg natrijevega risedronata, kar

ustreza 69,6 mg risedronske kisline.

Pomožne snovi so:

Jedro tablete

: celuloza, mikrokristalna, krospovidon A in magnezijev stearat.

Filmska obloga:

hipromeloza, makrogol 400, makrogol 8000 , hidroksipropilceluloza, brezvodni

koloidni silicijev dioksid, titanov dioksid [E171] in rdeči železov oksid [E172].

Izgled zdravila Actonel in vsebina pakiranja

Filmsko obložene tablete Actonel 75 mg so ovalne rožnate tablete velikosti 11,7 x 5,8, ki imajo na eni

strani oznako “RSN” in na drugi “75 mg”. Tablete so na voljo v pretisnih omotih po 2, 4, 6 ali 8 tablet.

Na trgu ni vseh navedenih pakiranj.

Način izdaje zdravila Actonel

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Imetnik dovoljenja za promet z zdravilom:

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Islandija

Izdelovalci:

Warner Chilcott Deutschland GmbH,

Dr.-Otto-Röhm-Str. 2-4,

64331 Weiterstadt, Nemčija

Balkanpharma-Dupnitsa AD

SE/H/0192/IB/109/G_v1.0

JAZMP-IB/109/G-16.5.2017

3, Samokovsko Shosse Str.

2600 Dupnitsa

Bolgarija

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

Belgija:

Actonel 75 mg filmomhulde tabletten,

Actonel 75 mg comprimé pelliculé,

Actonel 75 mg Filmtabletten

Ciper:

Actonel / ''2 συνεχόμενες ημέρες τον μήνα'' 75 mg επικαλυμμένα με λεπτό υμένιο

δισκία

Francija:

Actonel 75 mg comprimé pelliculé

Nemčija:

Actonel 75 mg Filmtabletten

Grčija:

Actonel / ''2 συνεχόμενες ημέρες τον μήνα'' 75 mg επικαλυμμένα με λεπτό υμένιο

δισκία

Irska:

Actonel 75 mg film-coated tablets

Italija:

Actonel 75 mg compresse rivestite con film

Luksemburg:

Actonel 75 mg comprimé pelliculé,

Nizozemska:

Actonel 75 mg, omhulde tabletten

Romunija:

Actonel 75 mg comprimate filmate

Slovenija:

Actonel 75 mg filmsko obložene tablete

Španija:

Actonel 75 mg comprimidos recubiertos con película

Švedska:

Optinate 75 mg filmdragerade tabletter

Navodilo je bilo nazadnje revidirano dne 16.5.2017.

9-11-2018

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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 ...

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

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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)

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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)

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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...

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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

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

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety

18-5-2018

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

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

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

Europe -DG Health and Food Safety

18-5-2018

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (Active substance: Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl Ethyl ester) )-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-poly(ethylene glycol)-este...

Europe -DG Health and Food Safety

15-5-2018

Orphacol (Laboratoires CTRS)

Orphacol (Laboratoires CTRS)

Orphacol (Active substance: Cholic acid) - Centralised - Yearly update - Commission Decision (2018)3061 of Tue, 15 May 2018

Europe -DG Health and Food Safety