Indrofar

Glavne informacije

  • Zaščiteno ime:
  • Indrofar 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 s 3 tabletami (1 x 3 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:
  • Indrofar 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-U-I-2112/11
  • Datum dovoljenje:
  • 17-09-2013
  • EAN koda:
  • 3837000125184
  • Zadnja posodobitev:
  • 19-01-2018

Podatki za bolnike

NAVODILO ZA UPORABO

Indrofar 150 mg filmsko obložene tablete

ibandronska kislina

Pred uporabo 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 ali farmacevta.

Navodilo vsebuje:

Kaj je zdravilo Indrofar in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Indrofar

Kako jemati zdravilo Indrofar

Možni neželeni učinki

Shranjevanje zdravila Indrofar

Dodatne informacije

1.

KAJ JE ZDRAVILO INDROFAR IN ZA KAJ GA UPORABLJAMO

Zdravilo Indrofar spada v skupino zdravil, ki jih imenujemo difosfonati. Vsebuje ibandronsko

kislino. Ne vsebuje hormonov.

Zdravilo Indrofar 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 Indrofar lahko pomaga zmanjšati možnost zlomov. Zmanjšanje zlomov je bilo dokazano za

hrbtenico, ne pa za kolke.

Zdravilo Indrofar vam je zdravnik predpisal za zdravljenje osteoporoze v pomenopavzi, ker

imate povečano tveganje za zlome. Osteoporoza je bolezen, zaradi katere postanejo kosti tanjše in

šibkejše, kar se najpogosteje pojavlja pri ženskah v pomenopavzi. V menopavzi jajčniki prenehajo

proizvajati ženski hormon estrogen, ki ženskam pomaga ohranjati zdravo okostje.

Prej ko ženska vstopi v menopavzo, 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,

pomanjkanje 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. Vendar pa osteoporoza zveča 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 Indrofar preprečuje izgubo kostne mase zaradi osteoporoze in pomaga pri ponovni gradnji

kosti. Na ta način zdravilo Indrofar 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 INDROFAR

Ne jemljite zdravila Indrofar

če ste alergični (preobčutljivi) na ibandronsko kislino ali katerokoli sestavino zdravila Indrofar.

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

ali težave s požiranjem.

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

če imate znižano koncentracijo kalcija v krvi, ali ste jo imeli v preteklosti. Prosimo, posvetujte

se z zdravnikom.

Otroci in najstniki

Zdravila Indrofar ne dajajte otrokom ali najstnikom.

Bodite posebno pozorni pri jemanju zdravila Indrofar

Nekateri ljudje morajo biti pri jemanju zdravila Indrofar 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,

če imate težave s požiranjem ali prebavo,

če se zdravite pri zobozdravniku ali boste imeli operacijo zob povejte svojemu zobozdravniku, da se

zdravite z zdravilom Indrofar.

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 Indrofar. Če se pri vas pojavijo ti simptomi, prenehajte jemati

zdravilo Indrofar 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 Indrofar.

acetilsalicilna kislina in druga nesteroidna protivnetna zdravila (NSAR, ki vključujejo

ibuprofen, natrijev diklofenak in naproksen) lahko dražijo želodec in črevesje. Difosfonati (kot

zdravilo Indrofar) imajo lahko enak učinek. Če jemljete zdravila proti bolečini ali protivnetna

zdravila med zdravljenjem z zdravilom Indrofar, bodite še posebno previdni.

Ko pogoltnete vašo mesečno tableto zdravila Indrofar, počakajte 1 uro preden zaužijete katerokoli

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

Jemanje zdravila Indrofar skupaj s hrano in pijačo

Ne jemljite zdravila Indrofar skupaj s hrano. Zdravilo Indrofar je manj učinkovito, če ga jemljete

skupaj s hrano.

Navadno vodo lahko pijete, drugih pijač pa ne (glejte 3. KAKO JEMATI ZDRAVILO

INDROFAR).

Nosečnost in dojenje

Ne jemljite zdravila Indrofar, če ste noseči ali dojite. Če dojite, boste morda morali z dojenjem

prenehati, da boste lahko jemali zdravilo Indrofar.

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

Vpliv na sposobnost upravljanja vozil in strojev

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

sposobnost za vožnjo in upravljanje s stroji.

Pomembne informacije o nekaterih sestavinah zdravila Indrofar

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

sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.

3.

KAKO JEMATI ZDRAVILO INDROFAR

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

posvetujte z zdravnikom ali s farmacevtom.

Odmerek

Običajen odmerek zdravila Indrofar je ena tableta enkrat na mesec.

Način in pot uporabe

Mesečno jemanje vaše tablete

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

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

Pogostnost uporabe

Vzemite eno tableto zdravila Indrofar v odmerku 150 mg enkrat na mesec.

Izberite si dan v mesecu, ki si ga boste lahko zapomnili. Lahko izberete ali isti datum (npr. 1. v

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

najbolje ustreza vašim navadam.

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

razen navadne vode.

Vzemite tableto zdravila Indrofar

ko zjutraj vstanete in

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.

Trajanje zdravljenja

Nadaljevanje jemanja zdravila Indrofar

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

Zdravilo Indrofar lahko zdravi osteoporozo le, dokler ga jemljete.

Če ste vzeli večji odmerek zdravila Indrofar, 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 - to bi lahko povzročilo, da bi zdravilo Indrofar 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 vaš naslednji načrtovani odmerek:

Če je do vašega 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 načrtovani odmerek čez več kot 7 dni…

vzemite eno tableto naslednje jutro potem, 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 Indrofar v istem tednu.

4.

MOŽNI NEŽELENI UČINKI

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

bolnikih.

Nemudoma se obrnite na medicinsko sestro ali zdravnika, če opazite kateregakoli od spodaj

naštetih resnih neželenih učinkov - morda boste potrebovali nujno medicinsko pomoč:

izpuščaj, srbenje, otekanje obraza, ustnic, jezika in žrela z oteženim dihanjem. Morda imate

alergično reakcijo na to zdravilo.

hudo bolečino v prsnem košu, hudo bolečino po požiranju hrane ali pijače, hudo slabost ali

bruhanje.

simptome, podobne gripi (če postanejo moteči ali trajajo več kot nekaj dni).

bolečino ali rano v ustih ali čeljusti.

bolečino ali vnetje oči (če traja dlje).

Drugi možni neželeni učinki

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

glavobol,

zgaga, bolečina v želodcu (kot sta ˝gastroenteritis˝ in ˝gastritis˝), slaba prebava, slabost, driska ali

zaprtje,

izpuščaj,

bolečina ali togost v mišicah, sklepih ali hrbtu,

gripi podobni simptomi (vključno s povišano telesno temperaturo, drgetanjem in mrazenjem,

občutjem neugodja, utrujenostjo, bolečino v kosteh in bolečimi mišicami ter sklepi),

utrujenost.

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

bolečina v kosteh,

občutek šibkosti,

omotica,

vetrovi.

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

preobčutljivostna reakcija: otekanje obraza, ustnic in ust (alergija),

srbenje,

bolečina ali vnetje oči.

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

stanje, pri katerem se odkrijejo kosti v ustih, imenovano osteonekroza čeljusti.

Redko lahko pride do neobičajnega zloma stegnenice, predvsem pri bolnikih, ki prejemajo dolgoročno

zdravljenje za osteoporozo. Če občutite bolečino, šibkost ali neprijeten občutek v stegnih, bokih ali

dimljah se posvetujte z zdravnikom, kajti ti simptomi so lahko zgodnji znaki možnega zloma

stegnenice.

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 INDROFAR

Zdravilo shranjujte nedosegljivo otrokom!

Za shranjevanje zdravila niso potrebna posebna navodila.

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

EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.

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 Indrofar

Zdravilna učinkovina je ibandronska kislina. Ena filmsko obložena tableta vsebuje 150 mg

ibandronske kisline (v obliki natrijevega ibandronata monohidrata).

Pomožne snovi so:

jedro tablete: mikrokristalna celuloza, laktoza monohidrat, mikrokristalna celuloza in koloidni

silicijev dioksid, krospovidon tipa A, kopovidon K vrednost 28, natrijev stearil fumarat;

obloga tablet: Opadry bel 02H28525 sestavljajo: hipromeloza 2910/5 cP (E464), titanov dioksid

(E171), propilenglikol, smukec.

Izgled zdravila Indrofar in vsebina pakiranja

Tablete zdravila Indrofar so bele, podolgovate, bikonveksne filmsko obložene tablete, z merami

približno 15,3 x 6.6mm. Tablete so na voljo v pretisnih omotih z 1 ali 3 tabletami.

Na trgu ni vseh navedenih pakiranj.

Način in režim izdaje zdravila

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Imetnik dovoljenja za promet z zdravilom

Vaia S.A.,

1, 28 Octovriou str.,

123 51 Ag. Varvara

Atene, Grčija

Izdelovalec

Specifar S.A.,

1, 28 Octovriou str.,

123 51 Ag Varvara

Atene, Grčija

To zdravilo je odobreno v naslednjih državah članicah EGP:

Nemčija

: Indrofar 150 mg filmtabletten

Češka

: Indrofar 150 mg potahované tablety

Madžarska: Indrofar 150 mg filmtabletta

Poljska

: Indrofar

Romunija

: Indrofar 150 mg comprimate filmate

Sloveská republika: Indrofar 150 mg filmom obalené tablety

Slovenija

: Indrofar 150 mg filmsko obložene tablete

Navodilo je bilo odobreno 9.6.2011

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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