FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/2/14/177/007 - 38 mg/ 8 mg, 1 chewable tablet EU/2/14/177/008 - 38 mg/ 8 mg, 3 chewable tablets EU/2/14/177/009 - 38 mg/ 8 mg, 6 chewable tablets EU/2/14/177/018 - 38 mg/ 8 mg, 15 chewable tablets EU/2/14/177/010 - 75 mg/ 15 mg, 1 chewable tablet EU/2/14/177/011 - 75 mg/ 15 mg, 3 chewable tablets EU/2/14/177/012 - 75 mg/ 15 mg, 6 chewable tablets EU/2/14/177/019 - 75 mg/ 15 mg, 15 chewable tablets EU/2/14/177/013 -150 mg/ 30 mg, 1 chewable tablet EU/2/14/177/014 -150 mg/ 30 mg, 3 chewable tablets EU/2/14/177/015 -150 mg/ 30 mg, 6 chewable tablets EU/2/14/177/020 -150 mg/ 30 mg, 15 chewable tablets
Icelandic: EU/2/14/177/007 - 38 mg/ 8 mg, 1 tuggutafla EU/2/14/177/008 - 38 mg/ 8 mg, 3 tuggutöflur EU/2/14/177/009 - 38 mg/ 8 mg, 6 tuggutöflur EU/2/14/177/018 - 38 mg/ 8 mg, 15 tuggutöflur EU/2/14/177/010 - 75 mg/ 15 mg, 1 tuggutafla EU/2/14/177/011 - 75 mg/ 15 mg, 3 tuggutöflur EU/2/14/177/012 - 75 mg/ 15 mg, 6 tuggutöflur EU/2/14/177/019 - 75 mg/ 15 mg, 15 tuggutöflur EU/2/14/177/013 -150 mg/ 30 mg, 1 tuggutafla EU/2/14/177/014 -150 mg/ 30 mg, 3 tuggutöflur EU/2/14/177/015 -150 mg/ 30 mg, 6 tuggutöflur EU/2/14/177/020 -150 mg/ 30 mg, 15 tuggutöflur
English: Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs for 4 weeks.
Icelandic: Meðferð við blóðmítlasmiti (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) hjá hundum í 4 vikur.
English: Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Icelandic: Gefið ekki dýrum sem hafa ofnæmi fyrir virka efninu eða einhverju hjálparefnanna.
English: After treatment of the nematode infestations, further flea and tick treatment should be continued with a monovalent product.
Icelandic: Eftir meðferð við þráðormunum skal halda áfram meðferð gegn flóm og mítlum með eingildu lyfi.
English: Therefore, the use of this product should be adapted to each individual case based on local information relating to disease status, including current susceptibility of the target parasites to the active substances in this product, in order to limit the possibility of a future selection for resistance.
Icelandic: Þess vegna skal notkun dýralyfsins aðlöguð að hverju tilfelli og byggð á upplýsingum á hverjum stað miðað við sjúkdómsstöðu, ásamt næmi sníkjudýrsins á virka efninu í lyfinu, til þess að takmarka hættuna á ónæmi fyrir lyfinu í framtíðinni.
English: Further treatments may be indicated throughout the flea and/or tick season.
Icelandic: Frekari meðferð mætti skoða meðan á flóa og mítla tímabilinu stendur.
English: Afoxolaner distributes into tissues with a volume of distribution of 2.6 ± 0.6 l/kg and a systemic clearance value of 5.0 ± 1.2 ml/h/kg.
Icelandic: Afoxolaner dreifist í vefi með dreifingarrúmmálið 2,6 ± 0,6 l/kg og gildi heildarúthreinsunar er 5,0±1,2 ml/klst./kg.
English: 4 Chemin du Calquet, 31000 Toulouse,
Icelandic: 31000 Toulouse,
English: Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family.
Icelandic: Afoxolaner er skordýraeyðandi og mítlaeyðandi efni af flokki isoxazolina.
English: Isoxazolines, among the chloride channel modulators, bind to a distinct and unique target site within the insect GABACls, thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Icelandic: Isoxazolín sem hafa áhrif á klóríðgöng bindast sérstökum stað á GABA stýrðum klóríðgöngum hjá skordýrinu og hamla þannig flutningi klóríðjóna yfir frumuhimnur framan og aftan taugamóta.
English: Macrogol 15 hydroxystearate Glycerol (E422) Triglycerides, medium-chain Citric acid monohydrate (E330) Butylhydroxytoluene (E321)
Icelandic: Miðlungslangar þríglýseríðkeðjur Sítrónusýrumónóhýdrat (E330) Bútýlhýdroxýtólúen (E321)
English: Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
Icelandic: Þess vegna skal notkun dýralyfsins byggja á mati hvers tilfellis og á faraldsfræðilegum upplýsingum á hverjum stað um næmi marktegundarinnar til þess að takmarka hættuna á ónæmi fyrir lyfinu í framtíðinni.
English: Milbemycin oxime distributes into tissues with a volume of distribution of 2.7 ± 0.4 l/kg and 2.6 ± 0.6 l/kg for the A3 and A4 forms, respectively.
Icelandic: Milbemýsínoxím dreifist í vefi með dreifingarrúmmálið 2,7 ±0,4 l/kg og 2,6 ±0,6 l/kg fyrir A3 og A4 gerðirnar í þeirri röð.
English: Chewable tablets Read the package leaflet before use.
Icelandic: Tuggutöflur Lesið fylgiseðilinn fyrir notkun.
English: The selective toxicity of afoxolaner between insects, acarines and mammals may be inferred by the differential sensitivity of the insects and acarines' GABA receptors versus mammalian GABA receptors.
Icelandic: Mismunandi eiturhrif afoxolaner hjá skordýrum, mítlum og spendýrum getur verið vegna mismunandi næmni GABA-viðtaka skordýra og mítla annars vegar og GABA-viðtaka spendýra hins vegar.
English: At the discretion of the veterinarian, infested dogs should be treated with an adulticide to remove adult heartworms.
Icelandic: Samkvæmt ákvörðun dýralæknis eru smitaðir hundar meðhöndlaðir með efni sem eyðir fullþroska hjartaormum (adulticide) .
English: If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please inform your veterinary surgeon.
Icelandic: Gerið dýralækni viðvart ef vart verður einhverra aukaverkana, jafnvel aukaverkana sem ekki eru tilgreindar í fylgiseðlinum eða ef svo virðist sem lyfið hafi ekki tilætluð áhrif.
English: In endemic areas, monthly administration of the product will reduce the level of infection with immature adults (L5) and adults of Angiostrongylus vasorum in the heart and lungs.
Icelandic: Á svæðum þar sem angiostrongylosis er landlægur mun mánaðarleg notkun lyfsins draga úr sýkingum með óþroskuðum fullvöxnum (L5) og fullvöxnum Angiostrongylus vasorum í hjarta og lungum.
English: Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
Icelandic: Flær og blóðmítlar verða að festa sig við hýsil og byrja að nærast til þess að verða útsett fyrir virka efninu.
English: Further monthly administrations of the product may be required based on clinical assessment and skin scrapings.
Icelandic: Áframhaldandi mánaðarlegar gjafir geta verið nauðsynlegar byggt á klínísku mati og húðskröpunum.
English: Mottled red to reddish brown, circular shaped (tablets for dogs 2-3.5 kg) or rectangular shaped (tablets for dogs >3.5-7.5 kg, tablets for dogs >7.5-15 kg, tablets for dogs >15-30 kg and tablets for dogs >30-60 kg).
Icelandic: Rauðdröfnóttar til rauðbrúnar, kringlóttar (töflur fyrir 2-3,5 kg hunda) eða ferkantaðar (töflur fyrir >3,5-7,5 kg hunda, töflur fyrir >7,5-15 kg hunda, töflur fyrir >15-30 kg hunda og töflur fyrir >30-60 kg hunda).
English: Post-marketing safety experience
Icelandic: Gögn um öryggi eftir markaðssetningu lyfsins
English: Prevention of heartworm disease:
Icelandic: Forvörn gegn hjartaormasmiti:
English: It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus, Ixodes hexagonus and I. scapularis, Amblyomma americanum and Haemaphysalis longicornis.
Icelandic: Það verkar á fullþroskaðar flær sem og allmargar mítlategundir svo sem Rhipicephalus sanguineus, Dermacentor reticulatus og D.variabilis, Ixodes ricinus, Ixodes hexagonus og I.scapularis, Amblyomma americanum, og Haemaphysalis longicornis.
English: Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection) with monthly administration.
Icelandic: Forvörn gegn thelaziosis smiti (sýking með fullvöxnum Thelazia callipaeda augnormum) með mánaðarlegri notkun.
English: Milbemycin oxime is an antiparasitic endectocide belonging to the group of macrocyclic lactones.
Icelandic: Milbemýsín oxím er endektósíð gegn sníklum og tilheyrir hópi makrósýklískra laktóna.
English: NEXGARD SPECTRA can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a monovalent flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infestations.
Icelandic: NEXGARD SPECTRA má nota sem hluta af árstíðabundinni meðferð gegn flóm og mítlum (með því að skipta út meðferð með eingildu flóa- og mítlalyfi) hjá hundum sem samtímis hafa greinst með þráðorma í meltingarvegi.
English: Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs.
Icelandic: Blóðmítlasmiti (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) hjá hundum.
English: The mean maximum concentration (Cmax) is 1822 ± 165 ng/ml in plasma found 2-4 hours (Tmax) after a 2.5 mg/kg afoxolaner dose.
Icelandic: Meðalhámarksþéttni (Cmax) er 1.822 ±165 ng/ml plasma 2-4 klst.
English: It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum, and Haemaphysalis longicornis.
Icelandic: Lyfið verkar á fullþroskaðar flær sem og allmargar mítlategundir svo sem Rhipicephalus sanguineus, Dermacentor reticulatus og D.variabilis, Ixodes ricinus og I.scapularis, Amblyomma americanum, og Haemaphysalis longicornis.
English: In regions where heartworm disease is present, dogs should be tested for existing heartworm infestation prior to administration of NEXGARD SPECTRA.
Icelandic: Þar sem hjartaormar eru landlægir skal greina hvort hundar séu með hjartaormasmit áður en þeim er gefið NEXGARD SPECTRA.
English: Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum) with monthly administration.
Icelandic: Forvörn gegn angiostrongylosis (með því að draga úr sýkingum með óþroskuðu fullvöxnu (L5) og fullvöxnu stigi Angiostrongylus vasorum) með mánaðarlegri notkun.
English: It can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Icelandic: Hægt er að nota það sem hluta af meðferðaráætlun til að hafa stjórn á húðbólgu vegna flóaofnæmis.
English: The veterinary medicinal product should be administered in accordance with the following table:
Icelandic: Dýralyfið á að gefa samkvæmt töflunni hér að neðan:
English: Milbemycin oxime is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and heartworm (Dirofilaria immitis larvae).
Icelandic: Milbemýsínoxím er virkt gegn allmörgum ormum í meltingarvegi (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostome ceylanicum, Trichuris vulpis), fullvöxnum og óþroskuðum fullvöxnum (L5) lungnaormum Angiostrongylus vasorum og hjartaormum (Dirofilaria immitis lirfur).
English: For each strength, the chewable tablets are available in the following pack sizes: Carton with 1 thermoformed blister containing 1, 3 or 6 chewable tablets or 15 thermoformed blisters containing 1 chewable tablet.
Icelandic: Askja með 1 hitamótaðri þynnu sem inniheldur 1, 3 eða 6 tuggutöflur eða 15 hitamótaðar þynnur með 1 tuggutöflu.
English: Prevention of heartworm disease (Dirofilaria immitis larvae) with monthly administration.
Icelandic: Forvörn gegn hjartaormaveiki (Dirofilaria immitis lirfu) með mánaðarlegri lyfjagjöf.
English: Parasite resistance to any particular class of parasiticides may develop following the frequent, repeated use of a product of that class.
Icelandic: Sníkjudýr geta myndað ónæmi gagnvart tilteknum flokkum sníklalyfja við tíða, endurtekna notkun dýralyfja úr sama flokki.
English: For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum), thelaziosis (adult Thelazia callipaeda) and/or treatment of gastrointestinal worm infestations is indicated.
Icelandic: Meðferð gegn flóa- og blóðmítlasmiti hjá hundum þegar fyrirbyggjandi meðferð gegn hjartaormaveiki (Dirofilara immitis lirfur), angiostrongylosis (fækkun á magni óþroskaðra fullvaxinna (L5) og fullvaxinna Angiostrongylus vasorum), thelaziosis (fullvöxnum Thelazia callipaeda) og/eða meðferð gegn þráðormasmiti í meltingarvegi á einnig við.
English: It is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and larvae of the heartworm Dirofilaria immitis.
Icelandic: Það vinnur á allmörgum ormum í meltingarvegi (Toxocara canis og Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), fullvöxnum og óþroskuðum fullvöxnum (L5) lungnaormum Angiostrongylus vasorum og lirfum hjartaormsins Dirofilaria immitis.
English: Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control.
Icelandic: Áframhaldandi verkun makrócýklískra laktóna ræður úrslitum um stjórn á útbreiðslu hjartaorma (Dirofilaria immitis).
English: Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense and Ancylostoma ceylanicum) and whipworm (Trichuris vulpis).
Icelandic: Spóluormar (Toxocara canis og Toxascaris leonina), hakaormar (Ancylostoma caninum, Ancylostoma braziliense og Ancylostoma ceylanicum) og svipuormar (Trichuris vulpis).
English: Treatment of flea and tick infestations and gastrointestinal worms:
Icelandic: Meðferð við flóa- og mítlasmiti og ormasmiti í meltingarvegi:
English: Milbemycin oxime increases glutamate binding with consequent enhanced chloride ion flow into the cell.
Icelandic: Milbemýsínoxím eykur glútamatbindingu sem þar af leiðandi magnar klórjónaflæði inn í frumuna.
English: Erythema and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely.
Icelandic: Örsjaldan hefur verið tilkynnt um roðaþrot og taugakvilla (krampar, ósamhæfðar hreyfingar og vöðvaskjálfti).
English: Pharmacotherapeutic group: antiparasitic products, endectocides, milbemycin combinations.
Icelandic: Sníklalyf, skordýraeyðandi, milbemýsin samsetningar.
English: The recommended dose should be strictly observed in collies or related breeds.
Icelandic: Fara skal nákvæmlega eftir skömmtum hjá collie-hundum eða skyldum tegundum.
English: Milbemycin oxime:
Icelandic: Milbemýsínoxím (mg)
English: Dogs living in heartworm endemic areas (where heartworm disease is present), or those which have travelled to endemic areas, may be infested with adult heartworms.
Icelandic: Fullþroska hjartaormar geta tekið sér bólfestu í hundum sem lifa á svæðum þar sem hjartaormar eru landlægir eða hjá hundum sem ferðast hafa til slíkra svæða.
English: Fleas and ticks need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of vector-borne diseases cannot be excluded.
Icelandic: Flær og mítlar verða að byrja að nærast á hýslinum til þess að verða útsett fyrir efninu afoxolaner.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Icelandic: Sérstakar varúðarreglur fyrir þann sem gefur dýrinu lyfið:
English: Heartworm disease prevention is critical.
Icelandic: Mikilvægt er að fyrirbyggja hjartaormasmit.
English: Manufacturer responsible for batch release: MERIAL,
Icelandic: Framleiðandi sem ber ábyrgð á lokasamþykkt:
English: Therefore, concomitant treatment with other P-gp substrates could lead to enhanced toxicity.
Icelandic: P-gp hvarfefnum leitt til aukinnar eiturverkunar.
English: Each chewable tablet contains 9.375 mg afoxolaner and 1.875 mg milbemycin oxime Each chewable tablet contains 18.75 mg afoxolaner and 3.75 mg milbemycin oxime Each chewable tablet contains 37.5 mg afoxolaner and 7.5 mg milbemycin oxime Each chewable tablet contains 75 mg afoxolaner and 15 mg milbemycin oxime Each chewable tablet contains 150 mg afoxolaner and 30 mg milbemycin oxime
Icelandic: Hver tuggutafla inniheldur 18,75 mg afoxolaner og 3,75 mg milbemýsínoxím
English: A single treatment is effective for gastrointestinal worms.
Icelandic: Meðferð einu sinni dugir gegn ormunum.
English: NEXGARD SPECTRA 9 mg/ 2 mg dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg dogs >30-60 kg afoxolaner / milbemycin oxime Tablets
Icelandic: NEXGARD SPECTRA 9 mg/ 2 mg hundar 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg hundar >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg hundar >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg hundar >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg hundar >30-60 kg afoxolaner / milbemýsínoxím Töflur
English: Marketing authorisation holder: MERIAL
Icelandic: VARNAÐARORÐIN „DÝRALYF“
English: Milbemycin oxime plasma concentrations peak quickly within the first 1-2 hours (Tmax) indicating that absorption from the chewable tablets is fast.
Icelandic: Plasmaþéttni milbemýsínoxíms nær hámarki fljótlega fyrstu 1-2 klst.
English: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg
Icelandic: NEXGARD SPECTRA 9 mg/ 2 mg tuggutöflur fyrir hunda 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tuggutöflur fyrir hunda >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tuggutöflur fyrir hunda >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tuggutöflur fyrir hunda >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tuggutöflur fyrir hunda >30-60 kg
English: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg Afoxolaner, milbemycin oxime
Icelandic: NEXGARD SPECTRA 9 mg/ 2 mg tuggutöflur fyrir hunda 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tuggutöflur fyrir hunda >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tuggutöflur fyrir hunda >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tuggutöflur fyrir hunda >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tuggutöflur fyrir hunda >30-60 kg Afoxolaner, milbemýsínoxím
English: NEXGARD SPECTRA 9 mg/ 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg chewable tablets for dogs >30-60 kg afoxolaner / milbemycin oxime
Icelandic: NEXGARD SPECTRA 9 mg/ 2 mg tuggutöflur fyrir hunda 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tuggutöflur fyrir hunda >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tuggutöflur fyrir hunda >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tuggutöflur fyrir hunda >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tuggutöflur fyrir hunda >30-60 kg afoxolaner / milbemýsínoxím
English: <Content (concentration)>
Icelandic: Innihald (þéttni)
English: 3 pre-filled syringes + 3 needles
Icelandic: 3 ml (10 mg/ml) 3 áfylltar sprautur + 3 nálar
English: 1 pre-filled syringe + 1 needle
Icelandic: 3 ml (10 mg/ml) 1 áfyllt sprauta + 1 nál
English: Pack size
Icelandic: Styrkleik i
English: ATC code: A16AB07.
Icelandic: A16AB07.
English: • Chest pain (not in the heart)
Icelandic: Brjóstverkur (ekki í hjartanu)
English: It will be given to you once every 2 weeks.
Icelandic: Hann er gefinn einu sinni á 2 vikna fresti.
English: An infusionassociated reaction can sometimes be very severe.
Icelandic: Innrennslistengd aukaverkun getur stundum verið mjög alvarleg.
English: EU/1/06/333/001 EU/1/06/333/002 EU/1/06/333/003
Icelandic: EU/1/06/333/001/IS EU/1/06/333/002/IS EU/1/06/333/003/IS
English: Some reactions were severe (see section 4.8).
Icelandic: Sumar aukaverkanir voru alvarlegar (sjá kafla 4.8).
English: Wilcoxon-Mann-Whitney Test p-value
Icelandic: Wilcoxon-Mann-Whitney próf p-gildi
English: Cmax (µg/ml) AUC∞ (µg•h/ml) CL (ml/h/kg) Vss (ml/kg) Effective half-life (h)
Icelandic: Cmax (g/ml) AUC (g•klst./ml) CL (ml/klst./kg) Vss (ml/kg)
English: The dose you receive is based on your body weight.
Icelandic: Skammturinn sem þú færð ræðst af líkamsþyngd þinni.
English: Instructions for proper use
Icelandic: Leiðbeiningar um rétta notkun
English: Manufacturer Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Icelandic: Framleiðandi Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Írlandi
English: • polysorbate 80 (E433).
Icelandic: • pólýsorbat 80 (E433).
English: Very common: may affect more than 1 in 10 people
Icelandic: Mjög algengar: geta komið fyrir hjá fleiri en 1 af hverjum 10 notendum
English: Kaplan-Meier survival rates at 12, 24 and 36 months of age were 26%, 9% and 7%, respectively.
Icelandic: KaplanMeier lifunarhlutfall við 12, 24 og 36 mánaða aldur var 26%, 9% og 7% tilgreint í sömu röð.
English: One additional patient died after study end and another one after withdrawal from the study.
Icelandic: Einn sjúklingur til viðbótar lést eftir rannsóknina og annar eftir að hafa hætt þátttöku í rannsókninni.
English: • Swelling around the eyes
Icelandic: Bjúgur umhverfis augu
English: IARs are described in section 4.8.
Icelandic: Innrennslistengdum aukaverkunum er lýst í kafla 4.8.
English: Subjects in the untreated historical cohort were born in 1993 or later.
Icelandic: Einstaklingar í ómeðhöndlaða sögulega samanburðarþýðinu voru fæddir 1993 eða síðar.
English: -The other ingredients are
Icelandic: -Önnur innihaldsefni eru
English: Two patients died and did not enter into the extension study.
Icelandic: Tveir sjúklingar létust og voru ekki hluti af viðbótarrannsókninni.
English: The 9 remaining patients either died (5 patients) or became invasive-ventilator dependent (4 patients).
Icelandic: Hinir 9 sjúklingarnir sem eftir voru, annaðhvort létust (5 sjúklingar) eða urðu háðir ífarandi öndunarhjálp (4 sjúklingar).
English: Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion related effects”).
Icelandic: Aukaverkanir komu aðallega fram á meðan verið var að gefa sjúklingunum lyfið eða stuttu eftir það („innrennslistengdar aukaverkanir“).
English: No interactions studies have been performed.
Icelandic: Ekki hafa verið gerðar neinar rannsóknir á milliverkunum.
English: In the untreated historical cohort 5 of 47 patients (10.6%) for whom data were available, were alive at age 30 months (2.5 years).
Icelandic: Í ómeðhöndlaða sögulega rannsóknarþýðinu voru 5 af 47 sjúklingum (10,6%), sem gögn voru fáanleg fyrir, á lífi við 30 mánaða aldur (2,5 ára).
English: Placebo (N = 30)
Icelandic: Lyfleysa (N = 30)
English: Some of these infusion related side effects were serious or life-threatening.
Icelandic: Sumar þessara innrennslistengdu aukaverkana voru alvarlegar eða lífshættulegar.
English: Other names for Pompe disease include glycogen storage disease type II (GSDII), acid maltase deficiency (AMD) and glycogenosis type II.
Icelandic: Önnur nöfn yfir Pompe-sjúkdóm eru glýkógengeymdargalli af gerð II (glycogen storage disease type II [GSD-II]), sýrumaltasaskortur (acid maltase deficiency [AMD]) og glýkógenkvilli af gerð II (glycogenosis type II).
English: In this group of patients a variable response has also been seen with respect to motor function.
Icelandic: Í þessum hópi sjúklinga hefur einnig sést mismunandi svörun hvað varðar hreyfigetu.