Fosamax

Glavne informacije

  • Zaščiteno ime:
  • FOSAMAX enkrat tedensko 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 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:
  • FOSAMAX enkrat tedensko 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-624/11
  • Datum dovoljenje:
  • 22-03-2011
  • EAN koda:
  • 3837000086690
  • Zadnja posodobitev:
  • 25-05-2018

Podatki za bolnike

NAVODILO ZA UPORABO

FOSAMAX enkrat tedensko 70 mg tablete

alendronska kislina

Pred uporabo natančno preberite navodilo, tudi če ste zdravilo že jemali!

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 katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni

omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.

Posebej pomembno je, da razumete informacije v poglavju 3. KAKO JEMATI ZDRAVILO

FOSAMAX, preden vzamete to zdravilo.

Navodilo vsebuje:

Kaj je zdravilo Fosamax in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Fosamax

Kako jemati zdravilo Fosamax

Možni neželeni učinki

Shranjevanje zdravila Fosamax

Dodatne informacije

1.

KAJ JE ZDRAVILO FOSAMAX IN ZA KAJ GA UPORABLJAMO

Kaj je zdravilo Fosamax?

Zdravilo Fosamax

spada v razred nehormonskih zdravil, ki jih imenujemo bisfosfonati. Zdravilo

Fosamax preprečuje izgubo kostne mase, do katere pride pri ženskah po menopavzi in pomaga pri

ponovni gradnji kosti. Zdravilo Fosamax zmanjša tveganje za zlome hrbtenice in kolka.

Za kaj uporabljamo zdravilo Fosamax?

Zdravnik vam je zdravilo Fosamax

predpisal za zdravljenje osteoporoze. Zdravilo Fosamax zmanjša

tveganje za zlome hrbtenice in kolka.

Zdravilo Fosamax se jemlje enkrat na teden.

Kaj je osteoporoza?

Osteoporoza je bolezen, zaradi katere postanejo kosti tanjše in šibkejše. Pogosta je pri ženskah po

menopavzi. V menopavzi jajčniki prenehajo proizvajati ženski hormon estrogen, ki ženskam pomaga

ohranjati zdravo okostje. Kot rezultat se pojavi izguba kostnine in kosti postanejo šibkejše. Prej ko

nastopi menopavza, večje je tveganje za razvoj osteoporoze.

Osteoporoza je v začetni fazi običajno brez simptomov. Če je ne zdravimo, lahko povzroči zlome

kosti. Kljub temu, da so zlomi običajno boleči, pa se zgodi, da zlomov hrbtenice ne opazimo, vse

dokler ne povzročijo zmanjšanja telesne višine. Do zlomov lahko pride že med običajnimi

vsakodnevnimi aktivnostmi, kot je dvigovanje, ali zaradi manjših poškodb, pri katerih se normalna

kost še ne bi zlomila. Največkrat se zlomijo kosti kolka, hrbtenice ali zapestja. Poleg bolečin lahko ti

zlomi povzročijo tudi znatne deformacije (kot je sključena drža ali grba) in zmanjšano gibljivost.

Kako lahko osteoporozo zdravimo?

Osteoporozo lahko zdravimo, za začetek zdravljenja pa nikoli ni prepozno. Zdravilo Fosamax ne le

preprečuje izgubo kostne mase, ampak celo pomaga pri ponovni gradnji kostnine, ki se je izgubila, ter

zmanjša tveganje za zlome hrbtenice in kolka.

Poleg zdravljenja z zdravilom Fosamax vam zdravnik lahko svetuje nekaj sprememb v načinu

življenja, ki pomagajo pri vaši bolezni. Te spremembe so:

Prenehanje kajenja

Kaže, da kajenje poveča hitrost, s katero izgubljate kostno maso in zato

povečuje tveganje za zlome.

Telesna aktivnost

Tako kot za mišice je tudi za kosti potrebna telesna aktivnost, da ostanejo

močne in zdrave. Preden začnete s programom telesne vadbe, se posvetujte s

svojim zdravnikom.

Uravnotežena dietna

prehrana

Zdravnik vam lahko svetuje dieto ali morebitne prehranske dodatke

(predvsem kalcij in vitamin D).

2.

KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO FOSAMAX

Ne jemljite zdravila Fosamax

če ste alergični (preobčutljivi) na natrijev alendronat ali katerokoli sestavino zdravila Fosamax.

če imate določene okvare požiralnika (del prebavne cevi med usti in želodcem), kot je njegovo

zoženje ali oteženo požiranje,

če ne morete pokončno sedeti ali stati vsaj 30 minut,

če vam je zdravnik povedal, da imate nizko raven kalcija v krvi,

Če mislite, da karkoli od naštetega velja za vas, tablet ne jemljite. Prej se pogovorite z zdravnikom in

upoštevajte njegov nasvet.

Bodite posebno pozorni pri jemanju zdravila Fosamax

Pomembno je, da preden začnete jemati zdravilo Fosamax, zdravniku poveste, če:

imate težave z ledvicami

imate kakršnekoli težave pri požiranju ali s prebavili

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

sluznice v spodnjem delu požiralnika)

so vam povedali, da imate nizke vrednosti kalcija v krvi

imate slabo stanje zob, bolezen dlesni, če nameravate na izdrtje zoba ali če nimate rednih

zobozdravniških pregledov

imate raka

prejemate kemoterapijo ali radioterapijo

jemljete kortikosteroide (kot sta prednizon ali deksametazon)

ste ali ste bili kadilec (ker to lahko poveča tveganje za težave z zobmi)

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

pregled.

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

zdravljenjem morate redno hoditi na zobozdravniške preglede. V primeru kakršnihkoli težav v ustih ali

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

zobozdravnikom.

Po zaužitju lahko pride do draženja, vnetja ali razjede požiralnika, pogosto s simptomi bolečine v

prsnem košu, zgage ali težkega/bolečega požiranja, še posebej če bolnik zdravila Fosamax ne zaužije

skupaj s polnim kozarcem vode in/ali če se v 30 minutah po zaužitju zdravila uleže. Ti neželeni učinki

se lahko stopnjujejo, če bolnik nadaljuje z jemanjem zdravila Fosamax potem, ko so se neželeni učinki

že pojavili.

Jemanje drugih zdravil

Verjetno je, da bi lahko dodatki kalcija, antacidi in nekatera peroralna (skozi usta) zdravila motili

absorpcijo zdravila Fosamax, če bi jih vzeli istočasno. Zato je pomembno, da upoštevate navodila v

poglavju 3. KAKO JEMATI ZDRAVILO FOSAMAX.

Določena zdravila za zdravljenje revme ali dolgotrajne bolečine, imenovana nesteroidna protivnetna

zdravila (NSAR-i) (na primer aspirin ali ibuprofen), lahko povzročijo težave s prebavili. Zato morate

biti pri sočasni uporabi teh zdravil z zdravilom Fosamax previdni.

Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo,

tudi če ste ga dobili brez recepta.

Jemanje zdravila Fosamax skupaj s hrano in pijačo

Verjetno je, da bi lahko hrana in pijača (vključno z mineralno vodo) zmanjšali učinek zdravila

Fosamax, če bi jih zaužili istočasno. Zato je pomembno, da upoštevate navodila v poglavju 3. KAKO

JEMATI ZDRAVILO FOSAMAX.

Otroci in mladostniki

Zdravila Fosamax se ne sme dajati otrokom in mladostnikom, mlajšim od 18 let.

Nosečnost in doj

enje

Zdravilo Fosamax je namenjeno le ženskam po menopavzi. Zdravila Fosamax ne smete jemati, če ste

noseči ali mislite, da bi lahko bili noseči, ali če dojite.

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

Vpliv na sposobnost upravljanja vozil in strojev

Pri zdravilu Fosamax so poročali o neželenih učinkih (vključno z zamegljenim vidom, omotico in

hudimi bolečinami v kosteh, mišicah ali sklepih), ki lahko vplivajo na vašo sposobnost vožnje ali

upravljanja s stroji. Odzivi posameznikov na zdravilo Fosamax se lahko razlikujejo (glejte poglavje

MOŽNI NEŽELENI UČINKI).

Pomembne informacije o nekaterih sestavinah zdravila Fosamax

Zdravilo Fosamax

vsebuje laktozo. Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev,

se pred uporabo tega zdravila posvetujte s svojim zdravnikom.

3.

KAKO JEMATI ZDRAVILO FOSAMAX

Pri jemanju zdravila Fosamax natančno upoštevajte zdravnikova navodila. Če ste negotovi, se

posvetujte z zdravnikom ali s farmacevtom.

Vzemite eno Fosamax tableto enkrat na teden

.

Da vam bo zdravilo Fosamax

pomagalo, morate upoštevati spodnja navodila.

Izberite tisti dan v tednu, ki vam najbolje ustreza, nato pa vsak teden na izbrani dan vzemite eno

Fosamax tableto.

Zelo pomembno je, da upoštevate navodila pod točkami 2, 3, 4 in 5. Tako bo tableta lažje hitro prišla

v želodec in možnost draženja požiralnika bo manjša.

Potem ko zjutraj vstanete in še preden zaužijete kakršnokoli hrano, pijačo ali drugo zdravilo,

pogoltnite celo tableto Fosamax s polnim kozarcem navadne vode (ne mineralne) (ne manj kot

200 ml).

Ne jemljite z mineralno vodo (z mehurčki ali brez).

Ne jemljite s kavo ali čajem.

Ne jemljite s sokom ali z mlekom.

Tablete ne zdrobite, ne žvečite in ne raztapljajte v ustih.

Potem ko ste pogoltnili Fosamax tableto, se ne ulezite, ampak še vsaj 30 minut ostanite v

pokončnem položaju (sede, stoje ali hodeč). Ne ulezite se do prvega dnevnega obroka hrane.

Zdravila Fosamax ne jemljite pred spanjem ali preden zjutraj vstanete.

Če se pojavijo težave ali bolečine pri požiranju, bolečine v prsih, zgaga ali če se težave z zgago

stopnjujejo, prenehajte jemati zdravilo Fosamax in se posvetujte z zdravnikom.

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

ali drugo zdravilo, vključno z antacidi, dodatki kalcija in vitamini. Zdravilo Fosamax je

učinkovito samo, če ga vzamete na tešče.

Če ste vzeli večji odmerek zdravila Fosamax, kot

bi smeli

Če po pomoti vzamete preveč tablet, popijte poln kozarec mleka in se takoj posvetujte z zdravnikom.

Ne izzovite bruhanja. Ne lezite.

Če ste pozabili vzeti zdravilo Fosamax

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

Ne vzemite

dveh tablet na isti dan.

Nadaljujte z jemanjem zdravila enkrat tedensko, kot ste prvotno načrtovali, na

izbrani dan.

Če ste prenehali jemati zdravilo Fosamax

Pomembno je, da zdravilo Fosamax jemljete tako dolgo, kot vam je predpisal zdravnik. Zdravilo

Fosamax lahko zdravi osteoporozo le, če ga redno jemljete.

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

4.

MOŽNI NEŽELENI UČINKI

Kot vsa zdravila ima lahko tudi zdravilo Fosamax

neželene učinke, ki pa se ne pojavijo pri vseh

bolnikih.

Kako pogosto se nek neželeni učinek pojavi, je opisano z naslednjimi izrazi:

Zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov

Pogosti: pojavijo se pri 1 do 10 bolnikih od 100 bolnikov

Občasni: pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov

Redki: pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov

Zelo redki: pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov

Zelo pogosti:

bolečina v kosteh, mišicah in/ali sklepih, ki je včasih huda

Pogosti:

zgaga, oteženo požiranje, bolečina pri požiranju, razjeda na požiralniku, ki lahko povzroči

bolečino v prsnem košu, zgago ali oteženo oz. boleče požiranje

otekanje sklepov

bolečina v trebuhu, občutek nelagodja v želodcu ali spahovanje po jedi, zaprtje, občutek polnega

ali napihnjenega želodca, driska, napenjanje

izpadanje las, srbenje

glavobol, omotica

utrujenost, otekanje dlani ali nog

Občasni

siljenje na bruhanje, bruhanje

draženje ali vnetje požiralnika ali želodca

črno ali katranu podobno blato

zamegljen vid, bolečina ali rdečina v očesu

izpuščaj, rdečina kože

prehodni gripi podobni simptomi, kot so boleče mišice, splošno slabo počutje in včasih zvišana

telesna temperatura, običajno ob začetku zdravljenja

motnje okušanja

Redki:

alergijske reakcije, kot so koprivnica, otekanje obraza, ustnic, jezika in/ali žrela, ki lahko otežijo

dihanje ali požiranje

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

prstih rok ali okoli ust

razjede v dvanajstniku ali želodcu (včasih hude ali s krvavitvami)

zoženje požiralnika

izpuščaj, ki se poslabša na soncu, hude reakcije na koži, na sluznici ust, nosu, oči ali spolovil.

Če se pri vas pojavijo taki simptomi, prenehajte jemati to zdravilo in se takoj posvetujte z

zdravnikom.

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 čeljustne kosti (osteonekroze), ki je

običajno povezana z zapoznelim zdravljenjem in okužbo, pogosto po izdrtju zoba. V primeru

takšnih simptomov se posvetujte z zdravnikom ali zobozdravnikom.

redko se lahko pojavi neobičajni zlom stegnenice, predvsem pri bolnikih, ki so 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.

razjede v ustih/žrelu po žvečenju ali sesanju tablete

Dobro je, če si zabeležite, kaj se vam je zgodilo, kdaj se je učinek pojavil in kako dolgo je trajal.

Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v

tem navodilu, obvestite svojega zdravnika ali farmacevta.

5.

SHRANJEVANJE ZDRAVILA FOSAMAX

Zdravilo shranjujte nedosegljivo otrokom!

Za shranjevanje zdravila niso potrebna posebna navodila.

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

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

navedenega meseca.

Ne odstranite tablete iz pretisnega omota, dokler je ne nameravate vzeti.

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.

DODATNE INFORMACIJE

Kaj vsebuje zdravilo Fosamax

Zdravilna učinkovina je natrijev alendronat trihidrat. Ena tableta vsebuje 70 mg alendronske kisline v

obliki 91,37 mg natrijevega alendronata trihidrata.

Pomožne snovi so mikrokristalna celuloza (E460), brezvodna laktoza, premrežen natrijev karmelozat

(E468) in magnezijev stearat (E572).

Izgled zdravila Fosamax in vsebina pakiranja

Fosamax tablete so ovalne, bele tablete, ki imajo na eni strani vtisnjen obris kosti, na drugi pa oznako

‘31’.

Pretisni omot v škatli s 4 tabletami (1 x 4 tablete).

Način izdaje zdravila Fosamax

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Šmartinska cesta 140

1000 Ljubljana

Slovenija

Izdelovalec

Merck Sharp & Dohme B.V.

Waarderweg 39

P.O. Box 581

2003 PC Haarlem

Nizozemska

Navodilo je bilo odobreno: 12.12.2012

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae 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 xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

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

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

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