Kefort

Glavne informacije

  • Zaščiteno ime:
  • Kefort 150 mg filmsko obložene tablete
  • Farmacevtska oblika:
  • filmsko obložena tableta
  • Sestava:
  • ibandronska kislina 150 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla z 1 tableto (1 x 1 tableta 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:
  • Kefort 150 mg filmsko obložene tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • ibandronska kislina

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 5363-I-956/12
  • Datum dovoljenje:
  • 28-06-2012
  • EAN koda:
  • 3837000128277
  • Zadnja posodobitev:
  • 19-01-2018

Podatki za bolnike

Kefort 150 mg filmsko obložene tablete

ibandronska kislina

Pred začetkom jemanja natančno preberite navodilo!

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.

1.

Navodilo vsebuje:

2.

Kaj je zdravilo Kefort in za kaj ga uporabljamo

3.

Kaj morate vedeti, preden boste vzeli zdravilo Kefort

4.

Kako jemati zdravilo Kefort

5.

Možni neželeni učinki

6.

Shranjevanje zdravila Kefort

Dodatne informacije

1.

KAJ JE ZDRAVILO KEFORT IN ZA KAJ GA UPORABLJAMO

Zdravilo Kefort spada v skupino zdravil, ki jih imenujemo

bisfosfonati

. Vsebuje ibandronsko kislino.

Ne vsebuje hormonov.

Zdravilo Kefort lahko zavre izgubo kostne mase tako, da zaustavi njeno nadaljnjo izgubo. S tem

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

Zdravilo Kefort pomaga zmanjšati možnost zloma. Zmanjšanje zlomov je bilo dokazano za hrbtenico,

ne pa za kolke.

Zdravilo Kefort vam je zdravnik predpisal

za zdravljenje osteoporoze, ker imate povečano

tveganje za zlome.

Osteoporoza je bolezen, zaradi katere postanejo kosti tanjše in šibkejše, kar se

najpogosteje pojavlja pri ženskah po menopavzi. V menopavzi jajčniki prenehajo proizvajati ženski

hormon estrogen, ki ženskam pomaga ohranjati zdravo okostje.

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

povečajo tveganje za zlome, so:

premajhen vnos kalcija in vitamina D s hrano,

kajenje ali čezmerno pitje alkohola,

premalo hoje ali drugih telesnih aktivnosti,

družinska obremenjenost z osteoporozo.

Veliko ljudi z osteoporozo nima simptomov. Če nimate simptomov, morda ne boste vedeli, da imate to

bolezen. Osteoporoza poveča tveganje za zlom kosti pri padcu ali poškodbi. Zlom kosti po 50. letu je

lahko znak osteoporoze. Osteoporoza prav tako lahko povzroči bolečino v hrbtu, zmanjšanje telesne

višine in ukrivljen hrbet.

Zdravilo Kefort preprečuje izgubo kostne mase zaradi osteoporoze in pomaga pri ponovni gradnji

kosti. Zdravilo Kefort zmanjša tveganje za zlom kosti.

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

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

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

2.

KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO KEFORT

Ne jemljite zdravila Kefort

Če ste alergični (preobčutljivi) na ibandronsko kislino ali katerokoli sestavino zdravila Kefort.

Če imate določene težave s požiralnikom (to je cev, ki vaša usta povezuje z želodcem), kot je

zožitev ali težave s požiranjem.

Če imate znižano koncentracijo kalcija v krvi, ali ste jo imel

i v preteklosti.

Prosimo,

posvetujte se z zdravnikom.

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

Zdravila Kefort ne dajajte otrokom in mladostnikom.

Bodite posebno pozorni pri jemanju zdravila Kefort

Nekateri ljudje morajo biti pri jemanju zdravila Kefort še posebno previdni. Posvetujte se s svojim

zdravnikom:

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

Če vaše ledvice ne delujejo normalno,

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

Kefort.

Če imate težave s požiranjem ali prebavo.

Lahko pride do draženja, vnetja ali razjede požiralnika (cevi, ki vaša usta povezuje z želodcem),

pogosto s simptomi, kot so huda bolečina v prsih, huda bolečina pri požiranju hrane in/ali pitju pijače,

huda slabost ali bruhanje, še posebej, če ne popijete polnega kozarca navadne vode in/ali če se uležete

prej kot v eni uri po zaužitju zdravila Kefort. Če se pri vas pojavijo ti simptomi, prenehajte jemati

zdravilo Kefort in takoj obvestite svojega zdravnika.

Jemanje drugih zdravil

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

tudi če ste ga dobili brez recepta, še posebno:

Dodatke, ki vsebujejo kalcij, magnezij, železo ali aluminij,

ker imajo lahko vpliv na

delovanje zdravila Kefort.

Acetilsalicilna kislina in druga nesteroidna protivnetna zdravila (NSAID)

, ki vključujejo

ibuprofen, natrijev diklofenakat in naproksen, lahko dražijo želodec in črevesje. Bisfosfonati

(kot zdravilo Kefort) imajo lahko enak učinek. Če jemljete

zdravila proti b

olečin

am

protivnetna zdravila

med zdravljenjem z zdravilom Kefort, bodite še posebno previdni.

Vsak mesec, ko pogoltnete tableto zdravila Kefort, počakajte 1 uro preden zaužijete katerokoli

drugo zdravilo

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

Jemanje zdravila Kefort

skupaj s hrano in pijačo

Ne jemljite zdravila Kefort skupaj s hrano.

Zdravilo Kefort je manj učinkovito, če ga jemljete

skupaj s hrano. Navadno vodo lahko pijete, drugih pijač pa ne (glejte 3. KAKO JEMATI

ZDRAVILO Kefort).

Nosečnost in dojenje

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

Ni zadostnih podatkov o uporabi zdravila Kefort pri nosečnicah. Študije na živalih so pokazale, da ima

zdravilo Kefort škodljiv vpliv na razmnoževanje. Zdravila Kefort torej ne smete uporabljati med

nosečnostjo.

Ni znano, ali se zdravilo izloča v mleko pri človeku. Študije na živalih so pokazale majhne ravni

zdravilne učinkovine v mleku. Zdravila Kefort torej ne smete uporabljati med dojenjem.

Vpliv na sposobnost upravljanja vozil in strojev

Lahko vozite in upravljate s stroji, ker je zelo malo verjetno, da bi zdravilo Kefort vplivalo na vašo

sposobnost za vožnjo in upravljanje s stroji.

Pomembne informacije o nekaterih sestavinah zdravila Kefort

Zdravilo Kefort vsebuje laktozo. Če vam je zdravnik povedal, da imate intoleranco za nekatere

sladkorje, se z njim posvetujte, preden vzamete to zdravilo.

3.

KAKO JEMATI ZDRAVILO KEFORT

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

z zdravnikom ali s farmacevtom.

Običajen odmerek zdravila

Kefort je ena tableta enkrat na mesec.

Mesečno jemanje vaše tablete

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

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

Vzemite eno tableto Kefort 150 mg enkrat na mesec.

Izberite si dan v mesecu

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

mesecu) ali isti dan (npr. prvo nedeljo v mesecu) za jemanje tablet zdravila Kefort. Izberite dan,

ki najbolje ustreza vaši rutini.

Vzemite tableto zdravila Kefort vsaj 6 ur po tem, ko ste zadnjič karkoli pojedli ali pili karkoli

razen navadne vode.

ko zjutraj vstanete

Pogoltnite tableto zdravila Kefort

preden karkoli pojeste ali popijete

(na prazen želodec).

Tableto pogoltnite s polnim kozarcem navadne vode

(ne manj kot 180 ml). Tablete

ne

vzemite z mineralno vodo, sadnim sokom ali katerokoli drugo pijačo.

Tableto pogoltnite celo -

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

ustih.

Naslednjo uro (60 minut)

po tem, ko ste vzeli svojo tableto:

se ne ulezite

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

zaide nazaj v vaš požiralnik;

ničesar

ne jejte

ničesar

ne pijte

(razen navadne vode, če jo potrebujete);

ne jemljite drugih zdravil.

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

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

Tablet

ne

jemljite zvečer ali preden zjutraj vstanete.

Nadaljevanje jemanja zdravila Kefort

Pomembno je, da vzamete zdravilo Kefort vsak mesec, dokler vam ga je predpisal zdravnik.

Zdravilo Kefort lahko zdravi osteoporozo le, dokler ga jemljete.

Če ste vzeli večji odmerek zdravila

Kefort, kot bi smeli

Če ste po pomoti vzeli več kot eno tableto,

popijte poln kozarec mleka in se takoj posvetujte s

svojim zdravnikom.

Ne izzovite bruhanja in ne lezite

– tako bi lahko zdravilo Kefort dražilo vaš požiralnik.

Če ste pozabili vzeti odmerek

Če ste pozabili vzeti tableto na jutro izbranega dne,

ne vzemite tablete pozneje v istem dnevu

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

Če je do vašega

naslednjega

načrtovanega odmerka le 1 do 7 dni...

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

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

Če

je vaš naslednji

načrtovani odmerek čez več kot 7 dni...

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

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

Nikoli ne vzemite dveh tablet zdravila Kefort v istem tednu.

4.

MOŽNI NEŽELENI UČINKI

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

Neželeni učinki se lahko pojavijo z določenimi pogostnostmi, ki so opredeljene takole:

zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov,

pogosti: pojavijo se pri 1 do 10 od 100 bolnikov,

občasni: pojavijo se pri 1 do 10 od 1.000 bolnikov,

redki: pojavijo se pri 1 do 10 od 10.000 bolnikov,

zelo redki: pojavijo se pri manj kot 1 od 10.000 bolnikov,

ni znano: pogostnosti ni mogoče oceniti na podlagi podatkov, ki so na voljo.

Pogosti neželeni učinki so zgaga, slaba prebava, driska, bolečina v trebuhu in slabost.

Zdravilo

Kefort

lahko draži požiralnik, čemur pa se običajno lahko izognete, če zdravilo

jemljete

natančno po navodilih. Če pri vas nastopijo simptomi, kot so huda bolečina v prsih, huda

bolečina po požiranju hrane ali pijače, huda slabost ali bruhanje, o tem takoj obvestite svojega

zdravnika.

Drugi pogosti neželeni učinki vključujejo izpuščaj, krče v mišicah, bolečino v mišicah in sklepih ter

glavobol.

Vključujejo tudi gripi podobne simptome (bolečino, občutje neugodja, utrujenost), ki so običajno

blagi in kratkotrajni ter izginejo kmalu po prvem odmerku. Jemanje zdravila Kefort lahko nadaljujete.

Če katerikoli neželeni učinek postane hujši ali traja dlje, se posvetujte s svojim zdravnikom.

Občasni neželeni učinki so omotica, bolečina v hrbtu in vetrovi.

Redki neželeni učinki so otekanje in srbenje obraza, ustnic in ust.

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 KEFORT

Zdravilo shranjujte nedosegljivo otrokom!

Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake

Uporabno do.

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.

DODATNE INFORMACIJE

Kaj vsebuje zdravilo Kefort

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

obliki natrijevega ibandronata monohidrata)

Pomožne snovi so:

jedro tablete

: laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat,

magnezijev stearat in brezvodni koloidni silicijev dioksid;

obloga tablete

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

Izgled zdravila Kefort in vsebina pakiranja

Kefort 150 mg filmsko obložene tablete so bele filmsko obložene tablete podolgovate oblike z oznako

LC na eni strani.

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

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

Na trgu ni vseh navedenih pakiranj.

Način in režim izdaje zdravila

Predpisovanje in izdaja zadravila je le na recept.

Imetnik dovoljenja za promet z zdravilom

Laboratorios Liconsa, SA

Gran Via Carlos II, 98, 7

floor

08028 Barcelona

ŠPANIJA

Izdelovalec

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), ŠPANIJA

Zdravilo je v

državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:

Avstrija: Kefort 150 mg Filmtabletten

Bolgarija: Kefort 150 mg Филмирана таблетка

Češka: Kefort 150 mg potahované tablety

Estonija: Kefort 150 mg

Francija: Kefort 150 mg Comprimés pelliculés

Nemčija: Kefort 150 mg Filmtabletten

Grčija Kefort 150 mg Επικαλυμμένο με λεπτό υμένιο δισκίο

Irska: Kefort 150 mg Film-coated tablets

Italija: Kefort 150 mg Compressa rivestita con film

Latvija: Kefort 150 mg Apvalkotās tabletes

Litva: Kefort 150 mg Plėvele dengtos tabletės

Norveška: Kefort 150 mg Tablett, filmdrasjert

Poljska: Kefort

Portugalska: Kefort 150 mg

Slovenija: Kefort 150 mg filmsko obložene tablete

Slovaška: Kefort 150 mg

Velika Britanija: Kefort 150 mg Film-coated tablets

Navodilo je bilo odobreno

5.8.2010

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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