Cardiopirin

Glavne informacije

  • Zaščiteno ime:
  • Cardiopirin 100 mg gastrorezistentne tablete
  • Farmacevtska oblika:
  • gastrorezistentna tableta
  • Sestava:
  • acetilsalicilna kislina 100 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 30 tabletami (3 x 10 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:
  • Cardiopirin 100 mg gastrorezistentne tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • acetilsalicilna 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-1446/13
  • Datum dovoljenje:
  • 04-09-2013
  • EAN koda:
  • 3837000099355
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

JAZMP-IB/017-30.08.2016

Navodilo za uporabo

Cardiopirin 100 mg gastrorezistentne tablete

acetilsalicilna 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 Cardiopirin in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Cardiopirin

Kako jemati zdravilo Cardiopirin

Možni neželeni učinki

Shranjevanje zdravila Cardiopirin

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Cardiopirin in za kaj ga uporabljamo

Zdravilo Cardiopirin vsebuje acetilsalicilno kislino in deluje antitrombotično (zavira agregacijo

trombocitov), zato zmanjša nastajanje krvnih strdkov.

Gastrorezistentne tablete zdravila Cardiopirin se za razliko od običajnih tablet ne raztopijo v želodcu,

ampak v tankem črevesu. Zdravilo Cardiopirin zato manj draži želodčno sluznico kot običajne tablete

z acetilsalicilno kislino.

Zdravilo Cardiopirin uporabljamo za:

zmanjšanje tveganja ponovnega srčnega infarkta,

zmanjšanje tveganja pojava novih žilnih zapor po operacijah na žilah, npr. po premostitveni

operaciji koronarnih arterij,

preprečevanje ponovitve prehodnih ishemičnih napadov in možganske kapi.

2.

Kaj morate vedeti, preden boste vzeli zdravilo Cardiopirin

Ne jemljite zdravila Cardiopirin

če ste alergični na acetilsalicilno kislino ali katero koli sestavino tega zdravila (navedeno v

poglavju 6),

če ste alergi

čni na druge salicilate ali druga nesteroidna protivnetna in protirevmatična zdravila,

pri želodčnih in črevesnih razjedah,

če ste nagnjeni k nenormalnim krvavitvam, zmanjšanemu številu krvnih ploščic, hemofiliji,

pri zmanjšanem delovanju ledvic in ledvičnih kamnih (oksaluriji),

pri hudi jetrni okvari,

pri hudem srčnem popuščanju,

če jemljete metotreksat v odmerku 15 mg ali več na teden,

otroci, mlajši od 12 let,

v zadnjem trimesečju nosečnosti, saj lahko jemanje acetilsalicilne kisline v odmerku 100 mg na

dan škodljivo vpliva na nosečnost ali razvoj ploda.

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila Cardiopirin se posvetujte z zdravnikom ali farmacevtom.

JAZMP-IB/017-30.08.2016

Bodite posebno pozorni pri jemanju zdravila Cardiopirin:

pred načrtovanimi operacijami (tudi pred manjšimi, npr. pred odstranitvijo zoba). V tem

primeru obvestite zdravnika, da jemljete zdravilo Cardiopirin. Treba je upoštevati

antitrombotični učinek zdravila Cardiopirin.

če morate dodatno jemati druge salicilate ali druga nesteroidna protivnetna in protirevmatična

zdravila. O tem mora odločiti zdravnik.

kadar jemljete večje odmerke acetilsalicilne kisline več let. V tem primeru vas bo zdravnik

napotil na preiskave delovanja ledvic, saj se lahko razvije ledvična okvara.

če se pojavijo dlje časa trajajoče bruhanje, dehidracija, motnje zavesti in napadi krčev. V tem

primeru morate nemudoma obvestiti zdravnika.

če imate astmo, seneni nahod, če vam oteka nosna sluznica (nosni polipi) ali če imate kronično

bolezen dihal.

če imate redko dedno pomanjkanje glukoza-6-fosfat dehidrogenaze (hemolitično anemijo).

če imate katero drugo bolezen prebavil (npr. vnetje želodčne sluznice, ponavljajoče se razjede

na želodcu ali dvanajstniku ali krvavitve v prebavilih).

če imate motnje delovanja jeter ali ledvic. O teh stanjih morate obvestiti zdravnika.

če imate druge alergije (npr. kožne reakcije, srbenje, koprivnico).

če hkrati prejemate druga zdravila proti strjevanju krvi (npr. kumarine, heparin, razen v primeru

uporabe majhnih odmerkov heparina).

če hkrati prejemate metotreksat (zdravilo za zdravljenje raka ali revmatoidnega artritisa).

če ste bolnik s trombolizo. Zdravnik bo v tem primeru morda preverjal morebitne znake

zunanjih ali notranjih krvavitev.

če zanosite. V tem primeru takoj obvestite zdravnika.

Acetilsalicilna kislina v majhnih odmerkih zmanjša izločanje sečne kisline, kar lahko pri nekaterih

bolnikih, ki so nagnjeni k temu, povzroči napad putike.

Otroci in mladostniki

Zaradi možnosti pojava tako imenovanega Reyevega sindroma (življenjsko nevarnih zapletov z

bruhanjem, dehidracijo, motnjami zavesti in napadi krčev) se zdravilo Cardiopirin pri otrocih ne sme

uporabljati. Reyev sindrom so opazili pri posameznih otrocih in mladostnikih med uporabo

acetilsalicilne kisline.

Druga zdravila in zdravilo Cardiopirin

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

jemati katero koli drugo zdravilo.

Če zdravilo Cardiopirin jemljete skupaj z nekaterimi drugimi zdravili, se učinek zdravljenja lahko

spremeni.

Povečajo se:

učinki zdravil za preprečevanje nastanka krvnih strdkov (npr. varfarina, heparina, dipiridamola,

sulfinpirazona, tiklopidina, klopidogrela),

učinki zdravil, ki znižujejo krvni sladkor (sulfonilsečnin),

učinki zdravil za lajšanje bolečine in vnetja (npr. kortikosteroidov ali protivnetnih zdravil),

učinki zdravila za zdravljenje raka ali revmatoidnega artritisa (metotreksata),

možnosti za krvavitve v prebavilih ob sočasni uporabi glukokortikoidov (protivnetnih zdravil)

ali alkohola,

učinki zdravil s sulfonamidi (nekaterih zdravil za zdravljenje bakterijskih okužb),

učinki zdravil s ščitničnim hormonom trijodtironinom,

učinki zdravil za zdravljenje epilepsije, ki vsebujejo valprojsko kislino.

Povečajo se lahko tudi krvne koncentracije digoksina (zdravila za zdravljenje srčnega popuščanja),

barbituratov (zdravil za zdravljenje nespe

čnosti) in litija (zdravila za zdravljenje depresije in drugih

duševnih bolezni).

JAZMP-IB/017-30.08.2016

Zmanjšajo se:

učinki zdravil, ki odvajajo vodo iz telesa (spironolaktona in furosemida),

učinki zdravil, ki povečajo izločanje sečne kisline (probenecida, sulfinpirazona),

učinki zdravil, ki znižujejo krvni tlak (zaviralcev angiotenzinske konvertaze).

Sočasno jemanje ibuprofena (zdravila za lajšanje bolečine, zniževanje telesne temperature in

zdravljenje vnetnih obolenj) in zdravila Cardiopirin lahko zmanjša antitrombotično delovanje zdravila

Cardiopirin.

Pri jemanju antacidov (zdravil za nevtralizacijo želodčne kisline) skozi daljše obdobje bo morda treba

povečati odmerek zdravila Cardiopirin.

Ob sočasnem zdravljenju s tetraciklini (zdravili za zdravljenje okužb) je potreben najmanj 1- do 3-urni

presledek med uporabo obeh zdravil.

Previdnost je potrebna ob hkratnem jemanju zdravil za preprečevanje zavrnitve presadka (ciklosporina

in takrolimusa).

Zdravilo Cardiopirin skupaj s hrano in pijačo

Ob sočasnem jemanju zdravila Cardiopirin in uživanju alkohola se lahko poveča nevarnost krvavitve v

prebavilih. Tablete se lahko vzame neodvisno od hrane.

Nosečnost in dojenje

Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z

zdravnikom ali farmacevtom, preden vzamete to zdravilo.

Zdravilo Cardiopirin lahko zaradi vsebnosti acetilsalicilne kisline neugodno vpliva na nosečnost in/ali

razvoj zarodka oz. ploda. Nekateri podatki kažejo, da se lahko v zgodnji nosečnosti pojavijo spontani

splavi ali nepravilnosti pri plodu. V prvem in drugem trimesečju nosečnosti se zdravilo Cardiopirin ne

sme uporabljati, razen če je to nujno potrebno. Če zdravilo Cardiopirin uporablja ženska, ki poskuša

zanositi, ali če je uporabljeno v prvem ali drugem trimesečju nosečnosti, mora biti odmerek č

manjši, zdravljenje pa čim krajše. Uporaba zdravila Cardiopirin v zadnjem trimesečju nosečnosti lahko

povzroči nepravilnosti in motnje delovanja nekaterih organov (motnje delovanja srca in ožilja, motnje

delovanja ledvic, motnje strjevanja krvi, težave pri porodu). Zato se zdravilo Cardiopirin v zadnjem

trimesečju nosečnosti ne sme uporabljati.

Acetilsalicilna kislina se izloča z materinim mlekom, zato smejo doječe matere jemati zdravilo

Cardiopirin samo, če je to nujno potrebno.

Vpliv na sposobnost upravljanja vozil in strojev

Ni znano, da bi zdravilo Cardiopirin vplivalo na sposobnost upravljanja vozil ali strojev.

Zdravilo Cardiopirin 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 Cardiopirin

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

zdravnikom ali farmacevtom.

Tablete pogoltnite cele z zadostno količino tekočine (najbolje z vodo). Gastrorezistentnih tablet

zdravila Cardiopirin ne smete na kakršen koli način deliti (npr. prelomiti ali zdrobiti), saj lahko to

spremeni delovanje zdravila.

JAZMP-IB/017-30.08.2016

Uporaba pri odraslih:

Vzemite 1 tableto (100 mg acetilsalicilne kisline) enkrat dnevno. Na začetku zdravljenja lahko

zdravnik predpiše večji odmerek.

Zdravnik vam bo povedal, koliko časa bo trajalo zdravljenje. Zdravljenje je lahko dolgotrajno.

Uporaba pri otrocih:

Zdravilo Cardiopirin se ne sme uporabljati pri otrocih, mlajših od 12 let. O uporabi zdravila

Cardiopirin pri otrocih in mladostnikih, starih od 12 do 18 let, ni na voljo dovolj podatkov.

Uporaba pri bolnikih z okvaro jeter:

Zdravilo Cardiopirin se ne sme uporabljati pri bolnikih s hudo jetrno okvaro (glejte poglavje »Ne

jemljite zdravila Cardiopirin«).

Uporaba pri bolnikih z okvaro ledvic:

Zdravilo Cardiopirin se ne sme uporabljati pri bolnikih z okvaro ledvic (glejte poglavje »Ne jemljite

zdravila Cardiopirin«).

Če ste vzeli večji odmerek zdravila Cardiopirin, kot bi smeli

Znaki prevelikega odmerka in zastrupitve so slabost, bruhanje, želodčne bolečine ter vrtoglavica,

šumenje v ušesih, glavobol, zmedenost in hiperventilacija. Če opazite katerega od naštetih znakov, se

takoj posvetujte z zdravnikom.

Če ste pozabili vzeti zdravilo Cardiopirin

Vzemite svoj običajni odmerek takoj, ko se spomnite. Zdravljenje nadaljujte, kot je priporočeno. Ne

vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.

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

4.

Možni neželeni učinki

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

Pogosti neželeni učinki

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

zgaga, slabost, bruhanje, bolečina v trebuhu, driska, mikroskopske črevesne krvavitve.

Občasni neželeni učinki

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

preobčutljivostne reakcije, ki se kažejo kot oteženo dihanje in kožne reakcije,

črevesne krvavitve, razjede v črevesju. Pri hudih črevesnih krvavitvah opazimo temno obarvano

blato ali pa se pojavi bruhanje krvi.

Redki neželeni učinki

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

podaljšanje časa krvavitve, trombocitopenija (zelo zmanjšano število krvnih ploščic v krvi),

preobčutljivost, ki se kaže kot hude kožne reakcije, npr. eksudativni multiformni eritem

(spremembe na koži v obliki rdečine, izpuščaja, mehurčkov). Običajno jih spremljajo padec

krvnega tlaka, oteženo dihanje, anafilaktična reakcija in angionevrotični edem, še posebej pri

bolnikih z astmo.

astmatični napadi,

pri dolgotrajni uporabi velikih odmerkov acetilsalicilne kisline lahko pride do poškodbe ledvic.

Zelo redki neželeni učinki

(pojavijo se lahko pri največ 1 od 10.000 bolnikov):

hude krvavitve, ki so lahko življenjsko ogrožajoče (npr. možganska krvavitev), predvsem pri

bolnikih z nekontroliranim visokim krvnim tlakom in/ali pri hkratni uporabi z zdravili proti

strjevanju krvi,

nenormalno zmanjšanje koncentracije glukoze v krvi,

zvečana aktivnost jetrnih encimov.

JAZMP-IB/017-30.08.2016

Neznana pogostnost

(pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):

napadi putike pri bolnikih z zmanjšanim izločanjem sečne kisline,

glavobol, omotica, zmedenost, motnje sluha ali šumenje v ušesih.

Pri dolgotrajnem zdravljenju z acetilsalicilno kislino se zaradi prikritih črevesnih krvavitev lahko

pojavita slabokrvnost in pomanjkanje železa.

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

Univerzitetni klinični center Ljubljana, Interna klinika

Center za zastrupitve

Zaloška cesta 2

SI-1000 Ljubljana

Faks: + 386 (0)1 434 76 46

e-pošta: farmakovigilanca@kclj.si.

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

zdravila.

5.

Shranjevanje zdravila Cardiopirin

Zdravilo shranjujte nedosegljivo otrokom!

Shranjujte pri temperaturi do 30 ºC.

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini. Rok

uporabnosti zdravila se izteče na zadnji dan navedenega meseca.

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 Cardiopirin

Zdravilna učinkovina je acetilsalicilna kislina. Ena gastrorezistentna tableta vsebuje 100 mg

acetilsalicilne kisline.

Druge sestavine zdravila (pomožne snovi) so laktoza monohidrat, mikrokristalna celuloza,

brezvodni koloidni silicijev dioksid, krompirjev škrob, smukec, triacetin in 30-% disperzija

kopolimera (1:1) metakrilne kisline in etilakrilata.

Izgled zdravila Cardiopirin in vsebina pakiranja

Tableta je bele barve, okrogle oblike, brez zareze, z izbočeno spodnjo in zgornjo površino.

Gastrorezistentne tablete zdravila Cardiopirin so na voljo v škatli s 30 tabletami

(3 x 10 gastrorezistentnih tablet v pretisnem omotu).

Način in režim predpisovanja in izdaje zdravila Cardiopirin

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Imetnik dovoljenja za promet:

PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00 Praga 7, Češka

JAZMP-IB/017-30.08.2016

Izdelovalec:

G.L. Pharma GmbH, Schloßplatz 1, A-8502 Lannach, Avstrija

Navodilo je bilo nazadnje revidirano dne 30. 8. 2016.

17-11-2018

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

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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