FrancophonIA/ELRC3.0 huggingface dataset:
English: Pink, oval, approximately 10.3 x 4.8 mm, coated tablets, debossed “L” on one side and “50” on other side.
Icelandic: Bleikar, sporöskjulagaðar, u.þ.b. 10,3 x 4,8 mm, húðaðar töflur, greyptar með „L“ á annarri hliðinni og „50“ á hinni hliðinni.
English: 100 mg (1 tablet Lacosamide Accord 100 mg)
Icelandic: 100 mg (ein 100 mg Lacosamide Accord tafla)
English: Nausea Vomiting Constipation Flatulence
Icelandic: Hægðatregða Vindgangur Meltingartruflanir Munnþurrkur
English: 50 mg tablet: Iron oxide red (E172), iron oxide black (E172), indigo carmine aluminum lake (E132) 100 mg tablet: Iron oxide yellow (E172)
Icelandic: Rautt járnoxíð (E172), svart járnoxíð (E172), indigo carmine aluminum lake (E132) 100 mg tafla:
English: Titanium dioxide (E171) Lecithin (soya) Iron oxide yellow (E172)
Icelandic: Títantvíoxíð (E171) Lesitín (soja) Gult járnoxíð (E172)
English: Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Icelandic: Óhófleg vellíðunartilfinning, sjá og/eða heyra eitthvað sem ekki er raunverulegt; Ofnæmisviðbrögð við lyfinu, ofsakláði;
English: A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Icelandic: Í safngreiningu á slembiröðuðum, samanburðarrannsóknum með lyfleysu sem gerðar voru á flogaveikilyfjum kom einnig fram dálítið aukin hætta á sjálfsvígshugsunum og sjálfsvígshegðun.
English: Uncommon: may affect up to 1 in 100 children
Icelandic: Geta komið fyrir hjá allt að 1 af 100 börnum •
English: Lacosamide Accord 200 mg film coated tablets: EU/1/17/1230/013-016
Icelandic: Lacosamide Accord 200 mg filmuhúðaðar töflur EU/1/17/1230/013-016
English: Vertigo Tinnitus
Icelandic: 13. LOTUNÚMER
English: 50 mg (1 tablet Lacosamide Accord 50 mg)
Icelandic: 50 mg (ein 50 mg Lacosamide Accord tafla)
English: Salmon, oval, approximately 15.0 x 6.9 mm, coated tablets, debossed “L” on one side and “150” on other side.
Icelandic: Laxableikar, sporöskjulagaðar, u.þ.b. 15,0 x 6,9 mm, húðaðar töflur, greyptar með „L“ á annarri hliðinni og „150“ á hinni hliðinni.
English: Adolescents and children weighing 50 kg or more
Icelandic: Unglingar og börn 50 kg eða þyngri
English: Renal impairment
Icelandic: Sundl, ógleði
English: Each pack of 56 film-coated tablets for a 4-week treatment schedule contains: 14 film-coated tablets of Lacosamide Accord 50 mg 14 film-coated tablets of Lacosamide Accord 100 mg 14 film-coated tablets of Lacosamide Accord 150 mg 14 film-coated tablets of Lacosamide Accord 200 mg
Icelandic: 14 filmuhúðaðar töflur af 50 mg Lacosamide Accord 14 filmuhúðaðar töflur af 100 mg Lacosamide Accord 14 filmuhúðaðar töflur af 150 mg Lacosamide Accord 14 filmuhúðaðar töflur af 200 mg Lacosamide Accord
English: Lacosamide Accord 100 mg film coated tablets: EU/1/17/1230/005-008
Icelandic: Lacosamide Accord 100 mg filmuhúðaðar töflur EU/1/17/1230/005-008
English: Suicidal ideation Hallucination (1)
Icelandic: Sjálfsvígstilraun(1)
English: Lacosamide Accord 150 mg film coated tablets: EU/1/17/1230/009-012
Icelandic: Lacosamide Accord 150 mg filmuhúðaðar töflur EU/1/17/1230/009-012
English: Adolescents and children weighing 50 kg or more, and adults Monotherapy
Icelandic: Unglingar, börn 50 kg eða þyngri og fullorðnir Einlyfjameðferð
English: the package marked ‘Week 3' contains 14 tablets of 150 mg, the package marked ‘Week 4' contains 14 tablets of 200 mg .
Icelandic: Pakkning merkt „Vika 4“ inniheldur 14 200 mg töflur.
English: Tablet core: Microcrystalline cellulose, hydroxy propyl cellulose-L, hydroxy propyl cellulose (low substituted), silica colloidal anhydrous, crospovidone and magnesium stearate.
Icelandic: Örkristölluð sellulósa, hýdroxýprópýl sellulósi-L, hýdroxýprópýl sellulósi (lágþéttni), vatnsfrí kísilkvoða, krosspóvídón og magnesíum sterat.
English: In paediatric patients weighing less than 50 kg with severe renal impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of the maximum dose is recommended.
Icelandic: Hjá sjúklingum á barnsaldri sem eru undir 50 kg og hafa mikið skerta nýrnastarfsemi (CLCR ≤ 30 ml/mín.) og fyrir þá sem hafa nýrnasjúkdóm á lokastigi er mælt með 25% minnkun hámarksskammts.
English: Each film-coated tablet contains 200 mg lacosamide.
Icelandic: Hver filmuhúðuð tafla inniheldur 200 mg lacosamíð.
English: If you stop taking Lacosamide Accord
Icelandic: Ef hætt er að nota Lacosamide Accord
English: Taking Lacosamide Accord
Icelandic: Taka Lacosamide Accord
English: How to take Lacosamide Accord
Icelandic: Hvernig nota á Lacosamide Accord
English: Method of administration Lacosamide film-coated tablets are for oral use.
Icelandic: Lyfjagjöf Lacosamíð filmuhúðaðar töflur eru ætlaðar til inntöku.
English: Based on the analysis of pooled placebo-controlled clinical trials in adjunctive therapy in 1,308 patients with partial-onset seizures, a total of 61.9 % of patients randomized to lacosamide and 35.2 % of patients randomized to placebo reported at least 1 adverse reaction.
Icelandic: Alls greindu 61,9 % sjúklinga sem fengu lacosamíð samkvæmt slembivali og 35,2 % sjúklinga sem fengu lyfleysu samkvæmt slembivali frá a.m.k. einni aukaverkun byggt á greiningu úr sameinuðum klínískum rannsóknum á viðbótarmeðferð með samanburði við lyfleysu hjá 1308 sjúklingum með hlutaflog (partial onset seizures).
English: Each film-coated tablet contains 50 mg lacosamide.
Icelandic: Hver filmuhúðuð tafla inniheldur 50 mg lacosamíð.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Icelandic: Notkun annarra lyfja samhliða Lacosamide Accord Látið lækninn eða lyfjafræðing vita um öll önnur lyf sem eru notuð, hafa nýlega verið notuð eða kynnu að verða notuð.
English: Lacosamide Accord 50 mg Lacosamide Accord 100 mg Lacosamide Accord 150 mg Lacosamide Accord 200 mg film-coated tablets lacosamide
Icelandic: Lacosamide Accord 50 mg Lacosamide Accord 100 mg Lacosamide Accord 150 mg Lacosamide Accord 200 mg filmuhúðaðar töflur lacosamíð
English: Dark yellow, oval, approximately 13.0 x 6.0 mm, coated tablets, debossed “L” on one side and “100” on other side.
Icelandic: Dökkgular, sporöskjulagaðar, u.þ.b. 13,0 x 6,0 mm, húðaðar töflur, greyptar með „L“ á annarri hliðinni og „100“ á hinni hliðinni.
English: Each film-coated tablet contains 150 mg lacosamide.
Icelandic: Hver filmuhúðuð tafla inniheldur 150 mg lacosamíð.
English: Titration (incremental steps)
Icelandic: Skammtaaðlögun (stigsaukning)
English: How to store Lacosamide Accord
Icelandic: Hvernig geyma á Lacosamide Accord
English: Lacosamide Accord 200 mg film-coated tablets
Icelandic: Lacosamide Accord 200 mg filmuhúðaðar töflur
English: Each film-coated tablet contains 100 mg lacosamide.
Icelandic: Hver filmuhúðuð tafla inniheldur 100 mg lacosamíð.
English: Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Icelandic: Erfiðleikar með að halda jafnvægi, skjálfti, náladofi eða vöðvakrampar, dettni og mar; Erfiðleikar með minni, hugsun og finna réttu orðin, ringlun;
English: Lacosamide Accord 150 mg film-coated tablets
Icelandic: Lacosamide Accord 150 mg filmuhúðaðar töflur
English: Lacosamide Accord 200 mg film-coated tablets lacosamide
Icelandic: Lacosamide Accord 200 mg filmuhúðaðar töflur lacosamíð
English: Based on data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic impairment, a reduction of 25 % of the maximum dose should be applied.
Icelandic: Byggt á upplýsingum um fullorðna, ætti að minnka hámarksskammt um 25 % hjá börnum sem vega minna en 50 kg með vægt eða miðlungsskerta lifrarstarfsemi.
English: Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis); A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes).
Icelandic: Alvarleg húðviðbrögð sem geta falið í sér háan hita og önnur flensulík einkenni, útbrot í andliti, útbreidd útbrot, bólgna kirtla (stækkaðir eitlar).
English: Lacosamide Accord 50 mg film-coated tablets
Icelandic: Lacosamide Accord 50 mg filmuhúðaðar töflur
English: Lacosamide Accord 100 mg film-coated tablets
Icelandic: Lacosamide Accord 100 mg filmuhúðaðar töflur
English: Lacosamide Accord 150 mg film-coated tablets lacosamide
Icelandic: Lacosamide Accord 150 mg filmuhúðaðar töflur lacosamíð
English: Laboratory abnormalities
Icelandic: Laboratori Fundacio
English: EXP:
Icelandic: Tafla:
English: Bradycardia(1,2) Atrial Fibrillation Atrial Flutter (1,2)
Icelandic: Gáttasleglarof(1,2) Hægsláttur(1,2) Gáttatif(1,2) Gáttaflökt(1,2)
English: Lacosamide Accord 50 mg film-coated tablets lacosamide
Icelandic: Lacosamide Accord 50 mg filmuhúðaðar töflur lacosamíð
English: Nystagmus
Icelandic: INNIHALDSLÝSING
English: What Lacosamide Accord is
Icelandic: Lacosamide Accord inniheldur
English: 50 mg: Each film-coated tablet contains 0.105 mg of lecithin (soya) 100 mg: Each film-coated tablet contains 0.210 mg of lecithin (soya) 150 mg: Each film-coated tablet contains 0.315 mg of lecithin (soya) 200 mg: Each film-coated tablet contains 0.420 mg of lecithin (soya) For the full list of excipients, see section 6.1.
Icelandic: Hver filmuhúðuð tafla inniheldur 0,315 mg af lesitíni (soja) 200 mg:
English: Lacosamide Accord 100 mg film-coated tablets lacosamide
Icelandic: Lacosamide Accord 100 mg filmuhúðaðar töflur lacosamíð
English: Lacosamide Accord 50 mg film coated tablets: EU/1/17/1230/001-004
Icelandic: MARKAÐSLEYFISNÚMER Lacosamide Accord 50 mg filmuhúðaðar töflur EU/1/17/1230/001-004
English: Lacosamide Accord 100 mg film-coated tablets Lacosamide Accord 150 mg film-coated tablets Lacosamide Accord 200 mg film-coated tablets
Icelandic: Lacosamide Accord 100 mg filmuhúðaðar töflur Lacosamide Accord 150 mg filmuhúðaðar töflur Lacosamide Accord 200 mg filmuhúðaðar töflur
English: The efficacy of lacosamide as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) was established in 3 multicenter, randomized, placebo-controlled clinical trials with a 12-week maintenance period.
Icelandic: Í þremur fjölsetra, slembiröðuðum, klínískum samanburðarrannsóknum með lyfleysu með 12 vikna viðhaldstímabili var verkun lacosamíðs sem viðbótarmeðferð í ráðlögðum skömmtum (200 mg/sólarhring og 400 mg/sólarhring) staðfest.
English: 150 mg tablet: Iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172) 200 mg tablet: Indigo carmine aluminum lake (E132)
Icelandic: Rautt járnoxíð (E172), svart járnoxíð (E172), gult járnoxíð (E172) 200 mg tafla:
English: Maximum recommended dose in patients < 20 kg up to 12 mg/kg/day Maximum recommended dose in patients ≥ 20 kg to < 30 kg up to 10 mg/kg/day
Icelandic: ≥ 20 kg til < 30 kg allt að 10 mg/kg/sólarhring
English: Lacosamide Accord 50 mg film-coated tablets Lacosamide Accord 100 mg film-coated tablets Lacosamide Accord 150 mg film-coated tablets Lacosamide Accord 200 mg film-coated tablets lacosamide
Icelandic: Lacosamide Accord 50 mg filmuhúðaðar töflur Lacosamide Accord 100 mg filmuhúðaðar töflur Lacosamide Accord 150 mg filmuhúðaðar töflur Lacosamide Accord 200 mg filmuhúðaðar töflur
English: • If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you remember.
Icelandic: Ef gleymist að taka skammt skal taka gleymda skammtinn eins fljótt og munað er eftir honum ef minna en 6 klukkustundir eru síðan taka átti skammtinn.
English: Tablet core
Icelandic: Pólýetýlen glýkól
English: There are no adequate data from the use of lacosamide in pregnant women.
Icelandic: Takmörkuð gögn eru fyrirliggjandi um notkun lacosamíð á meðgöngu.
English: Polyethylene glycol Talc
Icelandic: Lifur og gall
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Aukaverkanir, settar upp í töflu
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TREATMENT INITIATION PACK ONLY Blister label - week 1
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM UPPHAFSMEÐFERÐAR PAKKI
English: Not known: frequency cannot be estimated from available data Changes in behaviour, not acting like themselves.
Icelandic: Breytingar í hegðun, hegða sér ólíkt sjálfum sér.
English: One tablet of Lacosamide Accord 200 mg contains 200 mg lacosamide.
Icelandic: MEÐ BLINDRALETRI Lacosamide Accord 200 mg
English: Lot:
Icelandic: Töflukjarni:
English: In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported.
Icelandic: Hjá sjúklingum með takttruflanavaldandi aðstæður hefur verið greint frá slegla hraðsláttarglöpum.
English: Lyophilisate: bottle (type I glass); solvent: bottle (type I glass or PET)
Icelandic: Frostþurrkað lyf: flaska (tegund I glas); leysir: flaska (tegund I glas eða PET)
English: --P1 Live gEP-P tkP-P double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL: 10P6.3P - 10P7.3P CCIDR50 Rper 2 ml (gEP-P: deleted glycoprotein E; tkP-P: deleted thymidine kinase; CCID: cell culture infectious dose)
Icelandic: R (2 ml) (gEP-P: úrfelling á glýkópróteini E; tkP-P: úrfelling á týmidín kínasa; CCID: skammtur af frumurækt sem veldur sýkingu (cell culture infectious dose))
English: Solvent: 1 bottle
Icelandic: 1 flaska
English: Packaging Content Package size Withdrawal period
Icelandic: Pakkninga-stærð Biðtími
English: Lyophilisate: 1 bottle
Icelandic: 1 flaska leysir:
English: Invented Name
Icelandic: Innihald
English: EU (MA) Number
Icelandic: --P1
English: Tengströminkatu 8, 20360 Turku
Icelandic: 8, 20360 Turku
English: Avenida Río de Janeiro, 60 - 66, planta 13 08016 Barcelona (España)
Icelandic: Río de Janeiro, 60 - 66, planta 13 08016
English: The elimination half-life (t½) is 40-50 minutes.
Icelandic: Helmingunartími brotthvarfs (t½) er 40-50 mínútur.
English: Bayer Austria Ges.m.b.H Herbststrasse 6-10
Icelandic: m.b.H Herbststrasse 6-10
English: VETOQUINOL Italia S.r.l Via Piana, 265
Icelandic: S.r.l Via Piana, 265
English: The product is not intended for repeat injections.
Icelandic: Lyfið er ekki ætlað til endurtekinnar inndælingar.
English: After withdrawal of the first dose, the product may be stored for 3 months at 25ºC.
Icelandic: Eftir að fyrsti skammtur hefur verið tekinn úr hettuglasinu, má geyma lyfið í 3 mánuðir við 25ºC.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Icelandic: Ef óskað er upplýsinga um þetta dýralyf, vinsamlegast hafið samband við fulltrúa markaðsleyfishafa á hverjum stað.
English: In cases of overdosing the following recommendations should be followed:
Icelandic: Ef ofskömmtun á sér stað skal fylgja eftirfarandi ráðleggingum:
English: The Marketing Authorisation Holder must ensure that the system of pharmacovigilance, as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
Icelandic: Markaðsleyfishafi skal tryggja að kerfi fyrir lyfjagát sem lýst er í I. hluta umsóknar um markaðsleyfið, hafi verið komið á fót og sé virkt áður en og á meðan lyfið er á markaði.
English: Shelf life after first opening: 3 months at 25°C.
Icelandic: Geymsluþol eftir að hettuglasið er fyrst tekið í notkun: 3 mánuðir við 25°C.
English: The product is intended for:
Icelandic: Lyfið er ætlað:
English: The apparent volume of distribution (Vd) is 2.2 L/kg and the elimination half-life (t½) is one hour.
Icelandic: Dreifingarrúmmál (Vd) er 2,2 l/kg og helmingunartími brotthvarfs (t½) er ein klukkustund.
English: Orion Pharma AB, Animal Health Box 85, SE-182 11 Danderyd
Icelandic: Box 85, SE-182 11 Danderyd
English: Do not use after the expiry date stated on the label and carton after EXP.
Icelandic: Notið ekki eftir fyrningardagsetningu á miðanum og öskjunni á eftir Fyrnist.
English: Dexdomitor is compatible with butorphanol and ketamine in the same syringe at least for two hours.
Icelandic: Dexdomitor er samrýmanlegt við bútorfanól og ketamín í sömu sprautu í að minnsta kosti tvær klukkstundir.
English: D-85737 Ismaning
Icelandic: 1 D-85737
English: The bioavailability of dexmedetomidine is 60% and the apparent volume of distribution (Vd) is 0.9 L/kg.
Icelandic: Aðgengi dexmedetomidins er 60% og dreifingarrúmmál (Vd) er 0,9 l/kg.
English: VIAL/MULTI PACKAGE
Icelandic: HETTUGLAS / FJÖLPAKKNING
English: Deutschland VETOQUINOL GmbH Reichenbachstr.
Icelandic: Deutschland VETOQUINOL GmbH
English: In a clinical study, dexmedetomidine contributed to postoperative analgesia for 0.5 - 4 hours.
Icelandic: Í klínískri rannsókn hafði dexmedetomidin verkjastillandi áhrif í 0,5-4 klst. eftir aðgerð.
English: Sedation may be reversed with atipamezole.
Icelandic: Róandi áhrifum má snúa við með atipamezoli.
English: ROUTE(S) OF ADMINISTRATION Dogs: IM, IV
Icelandic: ÍKOMULEIÐIR Hundar: i.m., i.v.
English: The premedication dose of dexmedetomidine is 125 - 375 micrograms/square metre body surface area, administered 20 minutes prior to induction for procedures requiring anaesthesia.
Icelandic: Skammtur dexmedetomidins til lyfjaforgjafar er 125-375 míkróg/m2 líkamsyfirborðs, gefinn 20 mínútum á undan innleiðslu vegna aðgerða sem þarfnast svæfingar.
English: Sintra Business Park, Nº7, Edifício 1 - Escritório 2K Zona Industrial de Abrunheira 2710-089 Sintra
Icelandic: Sintra Business Park, Nº7, Edifício 1Escritório 2K
English: Dexdomitor doses are based on body surface area:
Icelandic: Dexdomitor skammtar eru grundvallaðir á líkamsyfirborði:
English: In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Icelandic: Við inntöku eða sjálfsinndælingu fyrir slysni skal tafarlaust leita læknis og hafa meðferðis fylgiseðil en EKKI MÁ AKA þar sem slæving og breytingar á blóðþrýstingi geta komið fyrir.
English: MANUFACTURER'S BATCH NUMBER Batch:
Icelandic: 17. LOTUNÚMER FRAMLEIÐANDA Lotunr.:
English: It is recommended that animals are fasted for 12 hours prior to Dexdomitor administration.
Icelandic: Mælt er með því að dýrum sé haldið fastandi í 12 klukkustundir fyrir gjöf Dexdomitor.
English: Cats: The maximum plasma concentration is reached about 0.24 h after intramuscular administration.
Icelandic: Hámarksþéttni í plasma næst um það bil 0,24 klst. eftir inndælingu í vöðva.
English: If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.
Icelandic: Ef þungaðar konur meðhöndla lyfið skal gæta þess sérstaklega að sjálfsinndæling eigi sér ekki stað þar sem samdrættir í legi og lækkaður blóðþrýstingur í fóstri geta komið fram eftir að lyfið berst í líkamann fyrir slysni.
English: Dexdomitor contains dexmedetomidine as the active substance, which produces sedation and analgesia in dogs and cats.
Icelandic: Virka innihaldsefnið í Dexdomitor er dexmedetomidin, sem hefur róandi og verkjastillandi áhrif á ketti og hunda.
English: DOGS:
Icelandic: HUNDAR:
English: Dexdomitor, butorphanol and/or ketamine can be mixed in the same syringe as they have been shown to be pharmaceutically compatible.
Icelandic: Blanda má Dexdomitor, butorfanoli og/eða ketamini í sömu sprautu þar sem þau eru lyfjafræðilega samrýmanleg.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 ml contains:
Icelandic: VIRKT INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI 1 ml innheldur:
English: CATS:
Icelandic: KETTIR:
English: Dexmedetomidine doses are based on body surface area:
Icelandic: Dexmedetomidin skammtar eru grundvallaðir á líkamsyfirborði:
English: In some dogs and cats a decrease in respiratory rate may occur.
Icelandic: Hjá sumum hundum og köttum getur dregið úr öndunarhraða.
English: After concurrent exposure to a triple (3X) overdose of dexmedetomidine and 15 mg ketamine/ kg, atipamezole can be administered at the recommended dose level for reversal of effects induced by dexmedetomidine.
Icelandic: Eftir samtímis þrefalda ofskömmtun með dexmedetomidini og ketamini 15 mg/kg, má gefa atipamezol í ráðlögðum skömmtum til að snúa við áhrifum dexmedetomidins.
English: The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made.
Icelandic: Gera má ráð fyrir að samtímis notkun annarra lyfja, sem hafa róandi verkun á miðtaugakerfið, auki áhrif dexmedetomidins og skal því viðeigandi breyting gerð á skammtastærð.
English: Persons with known hypersensitivity to the active substance or any of the excipients should administer the product with caution.
Icelandic: Þeir sem hafa þekkt ofnæmi fyrir virka innihaldsefninu eða einhverju hjálparefnanna eiga að gæta varúðar við gjöf lyfsins.
English: Concomitant use of dexmedetomidine and butorphanol produces sedative and analgesic effects beginning no later than 15 minutes.
Icelandic: Samhliða notkun dexmedetomidins og butorfanols leiðir til róandi og verkjastillandi verkunar sem hefst eigi síðar en eftir 15 mínútur.
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one fifth (1/5) of the dose volume of Dexdomitor 0.1 mg/ml that was given to the dog, regardless of route of administration of Dexdomitor.
Icelandic: Skammtarúmmál atipamezols í styrkleikanum 5 mg/ml á að vera einn fimmti (1/5) af skammtarúmmáli Dexdomitor 0,1 mg/ml sem hundinum var gefið, án tillits til íkomuleiðar Dexdomitor.
English: Intramuscular dosing at 40 micrograms/kg (followed by ketamine or propofol) frequently resulted in sinus bradycardia and sinus arrhythmia, occasionally resulted in 1st degree atrioventricular block, and rarely resulted in supraventricular premature depolarizations, atrial bigeminy, sinus pauses, 2nd degree atrioventricular block, or escape beats/rhythms.
Icelandic: Þegar 40 míkróg/kg voru gefin í vöðva (og síðan ketamin eða propofol) olli það oft hægslætti (sinus bradycardia) og skútasláttarglöpum (sinus arrhythmia), stundum 1. stigs gáttasleglarofi og í mjög sjaldgæfum tilvikum ótímabærum afskautunum ofan slegils (supraventricular premature depolarizations), gáttatvítakti (atrial bigeminy), hjartsláttarhléum (sinus pause), 2. stigs gáttasleglarofi eða sláttar-/taktglöpum.
English: Cats: After administration of 40 micrograms dexmedetomidine/ kg bw intramuscularly concurrently with 5 mg ketamine /kg bw to cats, the maximum concentration of dexmedetomidine increased twofold but there was no effect on T max.
Icelandic: Eftir inndælingu dexmedetomidins í vöðva, 40 míkróg/kg líkamsþ., ásamt ketamini, 5 mg/kg líkamsþ., hjá köttum, jókst hámarksþéttni dexmedetomidins tvöfalt en engin áhrif komu fram hvað varðar Tmax.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/033/003-004
Icelandic: MARKAÐSLEYFISNÚMER EU/2/02/033/003-004
English: Intravenously: up to 375 micrograms/square metre body surface area Intramuscularly: up to 500 micrograms/square metre body surface area
Icelandic: Í bláæð: allt að 375 míkróg/m2 líkamsyfirborðs Í vöðva: allt að 500 míkróg/m2 líkamsyfirborðs
English: 6.5 Nature and composition of immediate packaging Cardboard box with 1 glass (Type I) vial of 20 ml (with filling volume of 15 ml) with a bromobutyl rubber stopper and aluminium cap.
Icelandic: Pappaaskja sem í er eitt 20 ml hettuglas úr gleri (tegund I) (sem í eru 15 ml) með brómóbútýl gúmmítappa og álhettu.
English: For information on adverse reactions, see section 4.6.Adverse reactions.
Icelandic: Vísað er til kafla 4.6 Aukaverkanir, hvað varðar aukaverkanir lyfsins.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Icelandic: FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT Heiti og heimilisfang framleiðenda sem eru ábyrgir fyrir lokasamþykkt
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 ml, 10 x 10 ml
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI SKAMMTA 10 ml, 10 x 10 ml