ALENAX

Glavne informacije

  • Zaščiteno ime:
  • ALENAX 70 mg tablete
  • Farmacevtska oblika:
  • tableta
  • Sestava:
  • alendronska kislina 70 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 4 tabletami (1 x 4 tablet 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:
  • ALENAX 70 mg tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • alendronska 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:
  • 5363-I-2279/10
  • Datum dovoljenje:
  • 04-11-2010
  • EAN koda:
  • 3837000103502
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

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Navodilo za uporabo

ALENAX 70 mg tablete

alendronska 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 z 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 z zdravnikom ali 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 ALENAX in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo ALENAX

Kako jemati zdravilo ALENAX

Možni neželeni učinki

Shranjevanje zdravila ALENAX

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo ALENAX in za kaj ga uporabljamo

Zdravilo ALENAX vsebuje zdravilno učinkovino natrijev alendronat.

Zdravilo ALENAX spada v skupino zdravil, ki se imenujejo difosfonati. Difosfonati se uporabljajo za

zdravljenje bolezni kosti, kot je osteoporoza.

Osteoporoza je tanjšanje ali krhkost kosti. Zdravilo ALENAX zdravi osteoporozo pri ženskah po

menopavzi. Zdravilo ALENAX zmanjša tveganje za zlome hrbtenice in kolka.

2.

Kaj morate vedeti, preden boste vzeli zdravilo ALENAX

Ne jemljite zdravila ALENAX:

če ste alergični na natrijev alendronat ali katero koli sestavino tega zdravila (navedeno v

poglavju 6),

če imate težave s požiralnikom (požiralnik je cev, ki povezuje vaša usta z vašim želodcem), kar

povzroča težave pri požiranju ali zatikanje hrane,

če ne morete stati ali sedeti vzravnano vsaj 30 minut,

če imate zelo nizke vrednosti kalcija v krvi (hipokalciemija).

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila ALENAX se posvetujte z zdravnikom ali farmacevtom

:

če imate težave z ledvicami,

če imate kakšne težave pri požiranju, s prebavo ali s črevesom,

če ste v zadnjem letu imeli želodčno razjedo, krvavitev ali kirurški poseg v želodcu, požiralniku

ali grlu,

če imate bolečine pri požiranju,

če vam je zdravnik povedal, da imate Barrettov požiralnik (stanje, povezano s spremembami

sluznice v spodnjem delu požiralnika),

če so vam povedali, da imate nizke vrednosti kalcija v krvi ali imate pomanjkanje vitamina D ali

hipoparatireoidizem (ki lahko vpliva na raven kalcija). To je treba zdraviti pred začetkom jemanja

zdravila ALENAX.

Lahko se pojavijo draženje, vnetje ali razjede požiralnika, pogosto s simptomi, kot so bolečine v prsnem

košu, zgaga, težave ali bolečine pri požiranju, zlasti če tablet ne vzamete s polnim kozarcem vode in/ali če

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se uležete manj kot 30 minut potem, ko ste vzeli tablete. Ti neželeni učinki se lahko poslabšajo, če po

pojavu le-teh še naprej jemljete tablete. Glejte navodila v poglavju ''Kako jemati zdravilo'' v nadaljevanju

tega navodila za uporabo, da boste izvedeli, kako morate jemati tablete. Če imate kakšna vprašanja, se

posvetujte z zdravnikom ali farmacevtom.

Težave z zobmi in čeljustmi

Zdravilo ALENAX lahko povzroči poškodbo (vključno z odmrtjem ali izgubo) kosti v čeljusti. To

tveganje je povečano:

če imate slabo stanje zob, bolezen dlesni, slabo vgrajene proteze, če nameravate na izdrtje zoba ali

če nimate rednih zobozdravniških pregledov,

če imate raka,

če prejemate kemoterapijo ali radioterapijo,

če jemljete kortikosteroide (kot sta prednizon ali deksametazon),

če jemljete zaviralce angiogeneze – zdravila, ki se uporabljajo pri zdravljenju raka za preprečevanje

rasti novih krvnih žil, npr. bevacizumab ali talidomid,

če ste ali ste bili kadilec.

Zdravnik vam bo lahko pred začetkom zdravljenja z zdravilom ALENAX svetoval zobozdravniški

pregled.

Pomembno je, da med zdravljenjem z zdravilom ALENAX vzdržujete dobro ustno higieno. Med

zdravljenjem morate redno hoditi na zobozdravniške preglede. V primeru kakršnih koli težav v ustih ali z

zobmi, kot so majavost zob, bolečina ali otekanje, se morate posvetovati z zdravnikom ali

zobozdravnikom.

Druga zdravila in zdravilo ALENAX

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

katero koli drugo zdravilo, tudi če ste ga dobili brez recepta, ali katero od naslednjih zdravil:

dodatke kalcija,

antacide (sredstvo, ki nevtralizira kislost želodčnega soka) za prebavne motnje,

kortikosteroide, kot sta prednizolon ali deksametazon, za zmanjšanje vnetja; pomemben je zadosten

vnos kalcija in vitamina D s hrano (dejavnik tveganja za težave z zobmi – glejte zgoraj ''Težave z

zobmi in čeljustmi''),

določena zdravila za zdravljenje revmatičnih obolenj oziroma kronične bolečine, imenovane NSAR

(npr. acetilsalicilna kislina in ibuprofen) lahko povzročajo prebavne težave. Pri sočasnem jemanju

zdravila ALENAX in teh zdravil je potrebna previdnost.

Po zaužitju zdravila ALENAX morate počakati še vsaj 30 minut, preden vzamete katero koli

drugo zdravilo.

Zdravilo ALENAX skupaj s hrano in pijačo

Hrana in pijača lahko ob sočasnem zaužitju zmanjšata absorpcijo zdravila ALENAX v kri. Zato

vzemite zdravilo ALENAX z navadno vodo vsaj 30 minut, preden kar koli pojeste ali popijete.

Nosečnost in dojenje

Zdravilo ALENAX je namenjeno samo za uporabo pri ženskah po menopavzi. Ne jemljite zdravila

ALENAX, če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev.

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

Vpliv na sposobnost upravljanja vozil in strojev

Pri uporabi alendronata so poročali o neželenih učinkih (zamegljenem vidu, omotici in hudih

bolečinah v kosteh, mišicah ali sklepih), ki lahko vplivajo na vašo sposobnost vožnje ali upravljanja

strojev. Ne vozite in ne upravljajte strojev, dokler niste prepričani, da to zdravilo ne vpliva na vas.

Zdravilo ALENAX vsebuje laktozo.

Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila

posvetujte z zdravnikom.

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3.

Kako jemati zdravilo ALENAX

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

posvetujte z zdravnikom ali farmacevtom.

Odrasli in starejši bolniki

Priporočeni odmerek je ena 70 mg tableta enkrat na teden.

Uporaba pri bolnikih z ledvičnimi težavami

Uporaba zdravila ALENAX pri bolnikih s hudimi ledvičnimi težavami ni priporočljiva.

Uporaba pri otrocih in mladostnikih

Zdravila ALENAX se ne sme dajati otrokom in mladostnikom.

Način uporabe

Zdravilo vzemite na prazen želodec, takoj, ko zjutraj vstanete iz postelje,

preden

kar koli

pojeste ali popijete.

Tableto pogoltnite celo, medtem ko ste v pokončnem položaju (sedite, stojite ali hodite).

Tableto vzemite skupaj s polnim kozarcem (ne manj kot 200 ml) navadne vode (ne mineralne

vode).

Ne vzemite z mineralno vodo (negazirano ali gazirano).

Ne vzemite s kavo ali s čajem.

Ne vzemite s sokom ali z mlekom.

Tablete ne drobite in ne žvečite ter je ne raztapljajte v ustih.

Ne jemljite

tablet zvečer. Po zaužitju zdravila ALENAX

ne lezite

, dokler česa ne pojeste.

Ko pogoltnete tableto, počakajte še vsaj 30 minut, preden zaužijete prvo hrano, pijačo ali drugo

zdravilo.

Prenehajte z jemanjem zdravila in se posvetujte z zdravnikom, če opazite sledeče:

občutljivost, bolečino in težave pri požiranju,

bolečino na sredini prsnega koša,

zgago, ki se pojavi na novo ali je močnejša kot običajno,

razjede v ustih in grlu.

Če ste vzeli večji odmerek zdravila ALENAX, kot bi smeli

Popijte poln kozarec mleka in takoj obvestite zdravnika ali urgentni oddelek najbližje bolnišnice. S seboj

vzemite preostanek zdravila (tablete in škatlico).

Ne izzovite

bruhanja.

Ne lezite.

V primeru

prekomernega odmerjanja zdravila lahko opazite katerega od naslednjih simptomov: razdražljiv želodec,

zgaga, vnetje požiralnika, bolečine v trebuhu, slabost, bruhanje krvi, krvavitev v črevo (gastritis),

razjede. Pojavijo se lahko spremembe v vrednostih laboratorijskih testov krvi (nizke vrednosti kalcija in

fosfatov v krvi).

Če ste pozabili vzeti zdravilo ALENAX

Če pozabite vzeti odmerek, vzemite eno tableto naslednje jutro, potem ko se spomnite. Ne vzemite dveh

tablet v istem dnevu, ampak nadaljujte z jemanjem ene tablete enkrat tedensko.

Če ste prenehali jemati zdravilo ALENAX

Odmerkov ne smete spreminjati ali zdravljenja prekiniti, ne da bi se prej posvetovali s svojim

zdravnikom.

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

4.

Možni neželeni učinki

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

Prenehajte z jemanjem tega zdravila in se takoj posvetujte z zdravnikom, če opazite katerega od

naštetih simptomov:

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Pogosti

(pojavijo se lahko pri manj kot 1 od 10 bolnikov):

bolečina v ustih, grlu, prsnem košu ali želodcu, ki je lahko povezana s hranjenjem. Lahko se

počutite napihnjeni, vas sili na bruhanje ali bruhate, nimate apetita ali se vam je zmanjšala

telesna masa. To so lahko znaki vnetja ali razjede v prebavilih. Če bruhate, lahko tudi opazite

delce, ki izgledajo kot majhna kavna zrnca, lahko pa odvajate črno, smolnato blato.

pojav ali poslabšanje zgage ali slabe prebave, bolečina v sredini prsnega koša ali bolečina pri

požiranju. Takoj, ko je mogoče, obiščite zdravnika, če se vam pojavi kateri koli od teh neželenih

učinkov.

Občasni

(pojavijo se lahko pri manj kot 1 od 100 bolnikov):

nelagodje ali bolečina v enem ali v obeh očesih. Lahko imate rdečino, zamegljen vid, solzne oči,

občutljivost na svetlobo ali lebdeče delce v očeh (sence, ki se premikajo preko vašega vidnega

polja).

Redki

(pojavijo se lahko pri manj kot 1 od 1.000 bolnikov)

:

alergijske reakcije, kot npr. koprivnica, otekanje obraza, ustnic, jezika in/ali žrela, ki lahko

otežuje dihanje ali požiranje (angioedem).

stanje kože s hudimi mehurji in krvavenjem iz ustnic, oči, ust, nosu in genitalij (Stevens-

Johnsonov sindrom) ali hude kožne reakcije, ki se običajno začnejo z bolečimi pordelimi

predeli, ki preidejo v obsežne mehurje, nato pa jim sledi obsežno luščenje plasti kože. Kožni

reakciji so lahko pridruženi: vročina in mrzlica, bolečine v mišicah in splošno slabo počutje

(toksična epidermalna nekroliza).

bolečina v ustih in/ali čeljusti, otekanje ali ranice v ustih, odrevenelost ali občutek pritiska v

čeljusti ali majanje zoba. To so lahko znaki poškodbe čeljustnice (osteonekroze), ki je običajno

povezana z zapoznelim zdravljenjem in okužbo, ki se pogosto pojavi po izdrtju zoba. V primeru

pojava takšnih simptomov se posvetujte z zdravnikom ali z zobozdravnikom.

neobičajni zlomi stegnenice, še posebno pri bolnikih na dolgotrajnem zdravljenju osteoporoze.

Posvetujte se z zdravnikom, če občutite bolečine, šibkost ali nelagodje v stegnu, kolku ali

dimljah, saj so to lahko zgodnji znaki možnega zloma stegnenice.

Zelo redki

(pojavijo se lahko pri manj kot 1 od 10.000 bolnikov)

:

V primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte z zdravnikom. To

so lahko znaki poškodbe kosti v ušesu.

V primeru pojava takšnih simptomov se posvetujte z zdravnikom.

Ostali možni neželeni učinki:

Zelo pogosti

(pojavijo se lahko pri več kot 1 od 10 bolnikov)

:

bolečine v kosteh, mišicah in/ali sklepih, ki so včasih hude

Pogosti

(pojavijo se lahko pri manj kot 1 od 10 bolnikov)

:

otekanje sklepov, otekanje rok ali nog

bolečine v trebuhu, neprijeten občutek ali občutek polnosti v želodcu ali spahovanje po jedi,

zaprtje, driska, vetrovi

izpadanje las, srbeča koža

glavobol, omotica, izguba ravnotežja ali občutek vrtenja (vrtoglavica), neobičajna šibkost

Občasni

(pojavijo se lahko pri manj kot 1 od 100 bolnikov)

:

občutek siljenja na bruhanje, bruhanje

izpuščaj, pordelost kože

kratkotrajni gripi podobni simptomi, kot npr. bolečine v mišicah, splošno slabo počutje in včasih

zvišana telesna temperatura. To se običajno pojavi ob začetku zdravljenja.

spremembe okusa

Redki

(pojavijo se lahko pri manj kot 1 od 1.000 bolnikov)

:

simptomi nizke ravni kalcija v krvi, vključno z mišičnimi krči ali spazmom in/ali mravljinčenjem

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v prstih oziroma okrog ust

zožitev požiralnika (ezofagealna striktura)

izpuščaj, ki se poslabša na soncu

Zdravniku ali farmacevtu takoj povejte o teh ali drugih nenavadnih simptomih.

V pomoč bo, če si boste zapisali vašo izkušnjo, kdaj se je začela in koliko je trajala.

Poročanje o neželenih učinkih

Če opazite katerega koli izmed neželenih učinkov, 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:

Javna agencija Republike Slovenije za zdravila in medicinske pripomočke

Sektor za farmakovigilanco

Nacionalni center za farmakovigilanco

Slovenčeva ulica 22

SI-1000 Ljubljana

Tel: +386 (0)8 2000 500

Faks: +386 (0)8 2000 510

e-pošta: h-farmakovigilanca@jazmp.si

spletna stran: www.jazmp.si

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

zdravila.

5.

Shranjevanje zdravila ALENAX

Zdravilo shranjujte nedosegljivo otrokom!

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

pretisnem omotu poleg oznake »Uporabno do:«. Rok uporabnosti zdravila se izteče 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 uporabljate več, se posvetujte s farmacevtom. Taki ukrepi pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo ALENAX

Ena tableta vsebuje 70 mg zdravilne učinkovine alendronske kisline v obliki natrijevega alendronata.

Druge sestavine zdravila so

laktoza monohidrat; celuloza,

mikrokristalna; povidon;

natrijev premreženi

karmelozat in magnezijev stearat.

Izgled zdravila ALENAX in vsebina pakiranja

Tablete ALENAX so bele, zaobljene na obeh straneh in z vtisnjeno oznako

"

AD70

"

na eni strani in

oznako

"

"

na drugi strani.

Zdravilo ALENAX je na voljo v pretisnih omotih po 4, 8 ali 12 tablet.

Zdravilo ALENAX je na voljo tudi v plastenkah po 4, 8 ali 12 tablet in plastenkah po 100 tablet

(pakiranje za razdeljevanje).

Plastenke lahko vsebujejo polnilo iz polietilena na vrhu pakiranja.

Na trgu morda ni vseh navedenih pakiranj.

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Imetnik dovoljenja za promet z zdravilom

Generics [UK] Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, Velika Britanija

Izdelovalci

Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, Velika Britanija

McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,

Dublin, 13, Irska

Način in režim izdaje zdravila

Rp - Predpisovanje in izdaja zdravila je le na recept.

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

Avstrija:

Alendronsäure Arcana 70 mg - einmal wöchentlich - Tabletten

Belgija:

Alendronate Mylan 70 mg, tabletten

Češka:

Alendrogen 70 mg, tablety

Danska:

Alendronat Mylan 70 mg tabletter

Finska:

Alendronat Mylan 70 mg tabletti

Grčija:

Alendronate/Mylan TAB 70 mg/TAB

Irska:

Fostepor Once weekly 70 mg Tablets

Italija:

Alendronato Mylan Generics

Nemčija:

Alendronsäure Mylan 70 mg Tabletten

Norveška:

Alendronat Mylan tabletter 70 mg

Madžarska: Alendis

Poljska:

Alendrogen tabletki, 70 mg

Portugalska: Ácido Alendrơnico Mylan

Slovaška:

Alendrogen 70 mg

Slovenija:

ALENAX 70 mg tablete

Švedska:

Alendronat Mylan Veckotablett

Navodilo je bilo nazadnje revidirano dne 11. 11. 2016.

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB 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 acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

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

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