FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Icelandic: - Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og þynnunni á eftir EXP.
English: Doses in patients from 4 years of age were defined by weight-based dose adaptations which have been established to achieve similar plasma concentrations to the ones observed in adults taking efficacious doses (section 5.2).
Icelandic: Skammtar hjá börnum frá 4 ára aldri voru ákvarðaðir með skammtaaðlögun sem tók mið af þyngd til að ná svipaðri plasmaþéttniog hjá fullorðnum sem tóku virka skammta (kafli 5.2).
English: Brivaracetam was evaluated in these patients in a short term openlabel pharmacokinetic study and an ongoing open-label extension study, in 16 subjects from 1 month to <4 years of age (see section 5.2).
Icelandic: Brivaracetam var metið hjá 16 einstaklingum á aldrinum frá 1 mánaða til <4 ára í opinni skammtíma rannsókn á lyfjahvörfum og í opinni framhaldsrannsókn sem enn stendur yfir (sjá kafla 5.2).
English: Briviact 75 mg film-coated tablets Each 75 mg film-coated tablet contains 283 mg lactose.
Icelandic: Hver 75 mg filmuhúðuð tafla inniheldur 283 mg af laktósa.
English: The percentages of patients with at least a 50 % reduction in seizure frequency were 20.3 %, 34.2 %, 39.5 %, and 37.8 % for placebo, 50 mg/day, 100 mg/day, and 200 mg/day, respectively.
Icelandic: 50% var 20,3% fyrir lyfleysu, 34,2% fyrir 50 mg/sólarhring, 39,5% fyrir 100 mg/sólarhring og 37,8% fyrir 200 mg/sólarhring.
English: One full 10 ml oral dosing syringe corresponds to 100 mg of brivaracetam.
Icelandic: Full 10 ml munngjafarsprauta samsvarar 100 mg af brivaracetami.
English: What Briviact looks like and contents of the pack Briviact 10 mg/ml oral solution is slightly viscous, clear, colourless to yellowish liquid.
Icelandic: Lýsing á útliti Briviact og pakkningastærðir Briviact 10 mg/ml mixtúra, lausn er aðeins seigfljótandi, tær, litlaus til gulleitur vökvi.
English: Animal studies did not detect any teratogenic potential of brivaracetam (see section 5.3).
Icelandic: Í dýrarannsóknum komu ekki fram hugsanleg vanskapandi áhrif brivaracetams (sjá kafla 5.3).
English: Briviact 100 mg film-coated tablets Each 100 mg film-coated tablet contains 377 mg lactose.
Icelandic: Hver 100 mg filmuhúðuð tafla inniheldur 377 mg af laktósa.
English: In a pharmacokinetic and pharmacodynamic interaction study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy subjects, there was no pharmacokinetic interaction but brivaracetam approximately doubled the effect of alcohol on psychomotor function, attention and memory.
Icelandic: Í lyfjahvarfa‑ og lyfhrifarannsókn á milliverkunum sem gerð var hjá heilbrigðum einstaklingum sem fengu 200 mg stakskammt af brivaracetami og samfellt innrennsli af etanóli 0,6 g/l urðu engar lyfjahvarfamilliverkanir en brivaracetam u.þ.b. tvöfaldaði áhrif alkóhóls á skynhreyfifærni, athygli og minni.
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs), including brivaracetam, in several indications.
Icelandic: Tilkynnt hefur verið um sjálfsvígshugsun og sjálfsvígshegðun hjá sjúklingum sem fá meðferð með flogaveikilyfjum, brivaracetam meðtalið, við ýmsum ábendingum.
English: As a child or adolescent weighing less than 50 kg, the maximum dose you will take is 1.5 mg for each kg of bodyweight twice a day.
Icelandic: Ef þú ert unglingur eða barn og vegur minna en 50 kg er hámarksskammturinn sem þú tekur 1,5 mg fyrir hvert kíló líkamsþyngdar tvisvar sinnum á dag.
English: Brivaracetam solution for injection/infusion is physically compatible and chemically stable when mixed with the following diluents
Icelandic: Brivaracetam stungulyf/innrennslislyf, lausn er efnislega samrýmanleg og efnafræðilega stöðug í blöndu með eftirfarandi þynningarlausnum.
English: What Briviact looks like and contents of the pack Briviact 10 mg/ml solution for injection/infusion is a clear, colourless, sterile solution.
Icelandic: Lýsing á útliti Briviact og pakkningastærðir Briviact 10 mg/ml stungulyf/innrennslislyf, lausn er tær, litlaus sæfð lausn.
English: The discontinuation rate due to adverse reactions was 3.5 %, 3.4 % and 4.0 % for patients randomized to brivaracetam at respectively the dose of 50 mg/day, 100 mg/day and 200 mg/day and 1.7 % for patients randomized to placebo.
Icelandic: Tíðni þess að meðferð var hætt vegna aukaverkana var 3,5% hjá sjúklingum sem var slembiraðað til að fá 50 mg/sólarhring, 3,4% hjá þeim sem fengu 100 mg/sólarhring, 4,0% hjá þeim sem fengu 200 mg/sólarhring og 1,7% hjá sjúklingum sem var slembiraðað til að fá lyfleysu.
English: Lacosamide
Icelandic: Lacosamíð
English: - As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is
Icelandic: - Ef þú ert unglingur eða barn sem vegur minna en 50 kg er hámarksskammturinn sem þú tekur
English: - If you weigh 20 kg or more, your doctor will recommend the use of the 5 ml oral syringe or the
Icelandic: - Ef þú vegur 20 kg eða meira mun læknirinn ráðleggja þér að nota 5 ml eða 10 ml munngjafarsprautuna sem fylgir með í pakkningunni til að tryggja að nákvæmur skammtur sé gefinn.
English: 50 mg/5 ml 10 vials solution for injection/infusion
Icelandic: 50 mg/5 ml 10 hettuglös stungulyf/innrennslislyf, lausn
English: Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.
Icelandic: Greint hefur verið frá viðbrögðum sem benda til ofnæmis (tegund 1) hjá litlum hópi sjúklinga (9/3.022) sem fengu brivaracetam í klínískri þróun.
English: The minimum extractible volume is 0.25 ml which is 2.5 mg of brivaracetam.
Icelandic: Lágmarksskömmtun er 0,25 ml sem samsvarar 2,5 mg af brivaracetami.
English: Briviact 25 mg film-coated tablets Each 25 mg film-coated tablet contains 94 mg lactose.
Icelandic: Hver 25 mg filmuhúðuð tafla inniheldur 94 mg af laktósa.
English: Common: may affect up to 1 in 10 people - restlessness and hyperactivity (psychomotor hyperactivity)
Icelandic: Geta komið fram hjá allt að 1 af hverjum 10 einstaklingum - óróleiki og ofvirkni (hughreyfitengd ofvirkni)
English: Brivaracetam is rapidly and completely absorbed after oral administration and the absolute bioavailablity is approximately 100 %.
Icelandic: Brivaracetam frásogast hratt og algjörlega eftir gjöf til inntöku og nýtingin er u.þ.b. 100%.
English: The dose should be administered in two equally divided doses, once in the morning and once in the evening.
Icelandic: Skammtinn skal gefa í tveimur jöfnum aðgreindum skömmtum, einu sinni að morgni og einu sinni að kvöldi.
English: As from the 1 ml graduation mark, each graduation corresponds to 0.25 ml which is 2.5 mg of brivaracetam.
Icelandic: Frá 1 ml strikinu táknar hvert strik 0,25 ml sem samsvarar 2,5 mg af brivaracetami.
English: Further seizure frequency reduction is obtained by increasing the dose to 100 mg/day and reaches a plateau at 200 mg/day.
Icelandic: á tíðni floga er náð með því að auka skammtinn í 100 mg/sólarhring og verður stöðug við 200 mg/sólarhring.
English: Children and adolescents weighing less than 50 kg - Your doctor may prescribe the injection only for a few days if you cannot take your medicine by mouth.
Icelandic: Læknirinn gæti kosið að láta þig taka aðeins lyfið í nokkra daga með inndælingu ef þú getur ekki tekið lyfið um munn.
English: Driving and using machines - You may feel sleepy, dizzy or tired while using Briviact.
Icelandic: - Þú getur fundið fyrir syfju, sundli eða þreytu á meðan þú notar Briviact.
English: Do not use this medicine after the expiry date which is stated on the cardboard box and bottle after EXP.
Icelandic: - Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á pappaöskjunni og glasinu á eftir EXP.
English: How to store Briviact
Icelandic: Hvernig geyma á Briviact
English: Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day and 200 mg/day.
Icelandic: Eftir svörun hvers sjúklings fyrir sig er hægt að aðlaga virkan skammt á bilinu 50 mg/dag til 200 mg/dag.
English: In vitro, brivaracetam did ot induce CYP1A2.
Icelandic: Brivaracetam virkjaði ekki CYP1A2 in vitro.
English: Embryotoxicity was observed in rabbits at a maternal toxic dose of brivaracetam with an exposure level 8-fold the clinical AUC exposure at the maximum recommended dose.
Icelandic: Eiturverkun á fóstur kom fram hjá kanínum við skammta brivaracetams sem höfðu eiturverkun fyrir móðurdýrið við útsetningu sem var 8‑föld klínísk AUC útsetning af ráðlögðum hámarksskammti.
English: Brivaracetam oral solution contains sodium.
Icelandic: Brivaracetam mixtúra, lausn inniheldur natríum.
English: The other ingredients are: sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), carmellose sodium, sucralose, sorbitol liquid, glycerol (E422), raspberry flavour, water, purified.
Icelandic: Natríumsítrat, vatnsfrí sítrónusýra, metýl parahýdroxýbenzóat (E218), natríum karmellósi, súkralósi, fljótandi sorbitól, glýseról (E422), hindberjabragðefni, hreinsað vatn.
English: No dose adjustment required
Icelandic: Ekki þörf á skammtaaðlögun
English: 10 mg/ml solution for injection/infusion is packed in 6 ml nominal capacity glass vials (type I) with siliconized bromobutyl rubber stoppers and sealed with an aluminium/polypropylene tear off cap. Each single use vial contains an extractable volume of not less than 5.0 ml of solution for injection/infusion.
Icelandic: 10 mg/ml stungulyfi/innrennslislyfi, lausn er pakkað í hettuglös úr gleri (gerð I) sem eru 6 ml að rúmmáli með sílikonhúðuðum tappa úr brómóbútýl gúmmíi og innsigluð með ál/pólýprópýlen afrífanlegri hettu.
English: For children weighing 50 kg or greater the brivaracetam starting dose was 50 mg/day and depending on response and tolerability, the dose was increased up to a maximum of 200 mg/day by weekly increments of 50 mg/day.
Icelandic: 50 kg eða meira fengu upphafsskammt af brivaracetami sem nam 50 mg/dag og eftir svörun og þoli barnanna var skammturinn aukinn í allt að 200 mg/dag með því auka skammtinn um 50 mg/dag í hverri viku.
English: It is unknown whether brivaracetam is excreted in human breast milk.
Icelandic: Ekki er vitað hvort brivaracetam skilst út í brjóstamjólk hjá konum.
English: The volume of distribution is 0.5 L/kg, a value close to that of the total body water.
Icelandic: Dreifingarrúmmál er 0,5 l/kg, gildi sem er nærri heildarvökvamagni í líkamanum.
English: In the clinical studies, although the numbers were limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently.
Icelandic: Þó að fjöldi þátttakenda hafi verið takmarkaður í klínískum rannsóknum kom ekki fram neinn ávinningur af notkun brivaracetams samanborið við lyfleysu ef sjúklingar tóku levetiracetam samhliða.
English: The pharmacokinetics of brivaracetam was not significantly affected by race (Caucasian, , Asian) in a population pharmacokinetic modeling from epilepsy patients.
Icelandic: Kynþáttur hafði ekki marktæk áhrif á lyfjahvörf brivaracetams (hvítur, asískur) í lyfjahvarfalíkani þýðis hjá sjúklingum með flogaveiki.
English: nervous excitement (agitation) - thoughts or attempts of harming or killing yourself: tell your doctor straight away - a decrease in white blood cells (called ‘neutropenia') - shown in blood tests
Icelandic: Hafið samband við lækninn tafarlaust - fækkun hvítra blóðkorna (kallað „daufkyrningafæð“) - kemur fram í blóðprófum.
English: Other medicines and Briviact
Icelandic: Notkun annarra lyfja samhliða Briviact
English: One full 5 ml oral dosing syringe corresponds to 50 mg of brivaracetam.
Icelandic: Full 5 ml munngjafarsprauta samsvarar 50 mg af brivaracetami.
English: Children (from 4 years of age) and adolescents weighing 50 kg or more The recommended starting dose is 50mg/day.
Icelandic: Börn (frá 4 ára aldri) og unglingar sem vega 50 kg eða meira Ráðlagður upphafsskammtur er 50 mg/dag.
English: Gender There are no clinically relevant differences in the pharmacokinetics of brivaracetam by gender.
Icelandic: Kyn Eftir kyni er enginn munur á lyfjahvörfum brivaracetams sem klínískt skiptir máli.
English: The daily dose of brivaracetam ranged from 5 to 200 mg/day across these studies.
Icelandic: Í þessum rannsóknum var skammtur brivaracetams á bilinu frá 5 til 200 mg/sólarhring.
English: In a study in elderly subjects (65 to79 years old; with creatinine clearance 53 to 98 ml/min/1.73 m²) receiving brivaracetam 400 mg/day in bid administration, the plasma half-life of brivaracetam was 7.9 hours and 9.3 hours in the 65 to 75 and >75 years groups, respectively.
Icelandic: 400 mg/sólarhring af brivaracetami, gefið í tveimur skömmtum, var helmingunartími brivaracetams í plasma 7,9 klst. hjá 65 til 75 ára og 9,3 klst. hjá >75 ára hópunum.
English: Briviact is administered as an injection or infusion into a vein by a doctor or a nurse.
Icelandic: Læknir eða hjúkrunarfræðingur munu gefa þér Briviact sem inndælingu eða innrennsli í bláæð.
English: None a based on a study involving the administration of a supratherapeutic dose of 400 mg/day brivaracetam.
Icelandic: Engin a byggt á rannsókn á gjöf 400 mg/sólarhring af brivaracetami sem er meiraen ráðlagður skammtur.
English: No clinical data are available in paediatric patients with hepatic impairment.
Icelandic: Engar klínískar upplýsingar liggja fyrir hjá börnum með skerta lifrarstarfsemi.
English: Excipients which may cause intolerance
Icelandic: Hjálparefni sem geta valdið óþoli
English: Coating - 10 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Icelandic: Töfluhúð - 10 mg filmuhúðaðar töflur: pólývínýl alkóhól, títan tvíoxíð (E171), makrógól 3350, talkúm.
English: Brivaracetam may also be initiated at 2 mg/kg/day based on physician assessment of need for seizure control.
Icelandic: 2 mg/kg/dag af brivaracetami til að byrja með eftir mati læknisins á nauðsynlegum skammti til að hafa stjórn á flogum.
English: Brivaracetam film-coated tablets contain lactose.
Icelandic: Brivaracetam filmuhúðaðar töflur innihalda laktósa.
English: Adults, adolescents and children weighing 50 kg or more - The recommended dose is from 25 mg to 100 mg taken twice a day.
Icelandic: Fullorðnir, unglingar og börn sem vega 50 kg eða meira - Ráðlagður skammtur er frá 25 mg til 100 mg sem tekinn er tvisvar sinnum á dag.
English: The minimum extractible volume is 1 ml which is 10 mg of brivaracetam.
Icelandic: Lágmarksskömmtun er 1 ml sem samsvarar 10 mg af brivaracetami.
English: Each ml of solution for injection/infusion contains 10 mg brivaracetam.
Icelandic: Hver ml af stungulyfi/innrennslislyfi, lausn inniheldur 10 mg brivaracetam.
English: (corresponding to 1.5 mg/kg/intake)
Icelandic: (samsvarar 1.5 mg/kg/gjöf)
English: In children and adolescents weighing less than 50 kg, a 1 mg/kg/day starting dose is recommended.
Icelandic: Hjá börnum og unglingum sem vega minna en 50 kg er ráðlagður upphafsskammtur 1 mg/kg/dag.
English: Briviact 10 mg/ml solution for injection/infusion 5 ml vial is packed in a carton box of 10 vials.
Icelandic: Briviact 10 mg/ml stungulyf/innrennslislyf, lausn 5 ml hettuglas er pakkað í pappaöskju með 10 hettuglösum.
English: White to off-white, round film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Icelandic: Hvítar til beinhvítar kringlóttar filmuhúðaðar töflur, 6,5 mm að þvermáli og auðkenndar með „u10“ á annarri hliðinni.
English: 5 ml oral dosing syringe
Icelandic: 5 ml munngjafarsprauta
English: Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Icelandic: S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgía.
English: When converting from oral to intravenous administration or vice versa, the total daily dose and frequency of administration should be maintained.
Icelandic: Þegar breytt er úr gjöf til inntöku í gjöf í bláæð eða öfugt skal halda heildardagskammti og tíðni lyfjagjafar.
English: In children and adolescents weighing 50 kg or greater, a 50 mg/day starting dose is recommended.
Icelandic: Hjá börnum og unglingum sem vega 50 kg eða meira er ráðlagður upphafsskammtur 50 mg/dag.
English: Briviact 25 mg are grey, oval, film-coated tablets of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
Icelandic: Briviact 25 mg eru gráar, sporöskjulaga filmuhúðaðar töflur, 8,9 mm x 5,0 mm að stærð og auðkenndar með „u25“ á annarri hliðinni.
English: Briviact 100 mg are green-grey, oval, film-coated tablets of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Icelandic: Briviact 100 mg eru grængráar, sporöskjulaga filmuhúðaðar töflur, 14,5 mm x 8,1 mm að stærð og auðkenndar með „u100“ á annarri hliðinni.
English: (corresponding to 0.5 mg/kg/intake)
Icelandic: (samsvarar 0,5 mg/kg/gjöf)
English: Potential interactions between brivaracetam (50 mg/day to 200 mg/day) and other AEDs were investigated in a pooled analysis of plasma drug concentrations from all phase 2-3 studies in a population pharmacokinetic analysis of placebo-controlled phase 2-3 studies, and in dedicated drugdrug interaction studies (for the following AEDs: carbamazepine, lamotrigine, phenytoin and topiramate).
Icelandic: Hugsanlegar milliverkanir brivaracetams (50 mg/sólarhring til 200 mg/sólarhring) og annarra flogaveikilyfja voru rannsakaðar með safngreiningu á plasmaþéttni lyfja í öllum II. stigs og III.
English: Pharmacokinetics is dose-proportional from 10 to at least 600 mg.
Icelandic: Lyfjahvörf eru skammtaháð frá 10 til a.m.k.
English: Citric acid anhydrous (for pH-adjustment) Methyl parahydroxybenzoate (E218) Carmellose sodium
Icelandic: Metýl parahýdroxýbenzóat (E218) Natríum karmellósi
English: Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Icelandic: Gular, sporöskjulaga filmuhúðaðar töflur, 11,7 mm x 6,6 mm að stærð og auðkenndar með „u50“ á annarri hliðinni.
English: Excipient(s) with known effect: Each ml of solution for injection/infusion contains 3.8 mg sodium.
Icelandic: Hver ml af stungulyfi/innrennslislyfi, lausn inniheldur 3,8 mg natríum.
English: To be taken into consideration for patients on a controlled sodium diet.
Icelandic: Taka verður tillit til þess hjá sjúklingum á natríumskertu fæði.
English: Briviact 75 mg are purple, oval, film-coated tablets of 13.0 mm x 7.3 mm and debossed with ‘u75' on one side.
Icelandic: Briviact 75 mg eru fjólubláar, sporöskjulaga filmuhúðaðar töflur, 13,0 mm x 7,3 mm að stærð og auðkenndar með „u75“ á annarri hliðinni.
English: Take the daily dose in two equal divided doses - one in the morning and one in the evening at about the same time each day.
Icelandic: Taka skal daglegan skammt í tveimur jöfnum, aðgreindum skömmtum, einn á morgnana og einn á kvöldin u.þ.b. á sama tíma á hverjum degi.
English: You will use Briviact together with other medicines for epilepsy.
Icelandic: Þú munt nota Briviact með öðrum flogaveikilyfjum.
English: (corresponding to 2 mg/kg/intake)
Icelandic: (samsvarar 2 mg/kg/gjöf)
English: Each ml contains 10 mg brivaracetam.
Icelandic: Hver ml inniheldur 10 mg brivaracetam.
English: 10 ml oral dosing syringe
Icelandic: 10 ml munngjafarsprauta
English: Briviact contains sodium
Icelandic: Briviact inniheldur natríum
English: The median tmax for tablets taken without food is 1 hour (tmax range is 0.25 to 3 h).
Icelandic: Miðgildi tíma fram að hámarksþéttni (tmax) fyrir töflur sem teknar eru án matar er 1 klst.
English: Grey, oval film-coated tablets with dimensions of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
Icelandic: Gráar, sporöskjulaga filmuhúðaðar töflur, 8,9 mm x 5,0 mm að stærð og auðkenndar með „u25“ á annarri hliðinni.
English: Brivaracetam is eliminated primarily by metabolism and by excretion in the urine.
Icelandic: Brotthvarf brivaracetams verður aðallega með umbroti og útskilnaði með þvagi.
English: Briviact 50 mg are yellow, oval, film-coated tablets of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Icelandic: Briviact 50 mg eru gular, sporöskjulaga filmuhúðaðar töflur, 11,7 mm x 6,6 mm að stærð og auðkenndar með „u50“ á annarri hliðinni.
English: (corresponding to 1 mg/kg/intake)
Icelandic: (samsvarar 1 mg/kg/gjöf)
English: Briviact 75 mg tablets brivaracetam
Icelandic: Briviact 75 mg töflur brivaracetam
English: Briviact 100 mg tablets brivaracetam
Icelandic: Briviact 100 mg töflur brivaracetam
English: What Briviact looks like and contents of the pack Briviact 10 mg are white to off-white, round, film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Icelandic: Briviact 10 mg eru hvítar til beinhvítar kringlóttar filmuhúðaðar töflur, 6,5 mm að þvermáli og auðkenndar með „u10“ á annarri hliðinni.
English: Children (from 4 years of age) and adolescents weighing less than 50 kg The recommended starting dose is 1 mg/kg/day.
Icelandic: Börn (frá 4 ára aldri) og unglingar sem vega minna en 50 kg Ráðlagður upphafsskammtur er 1 mg/kg/dag.
English: Green-grey, oval film-coated tablets with dimensions of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Icelandic: Grængráar, sporöskjulaga filmuhúðaðar töflur, 14,5 mm x 8,1 mm að stærð og auðkenndar með „u100“ á annarri hliðinni.
English: Iron oxide yellow (E172) Iron oxide red (E172).
Icelandic: Gult járnoxíð (E172) Rautt járnoxíð (E172).
English: Valproic acid
Icelandic: Pólývínýl alkóhól
English: Oral solution Slightly viscous, clear colourless to yellowish liquid.
Icelandic: Mixtúra, lausn Aðeins seigfljótandi, tær, litlaus til gulleitur vökvi.
English: BLISTER
Icelandic: Flensa
English: Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172).
Icelandic: Gult járnoxíð (E172) Rautt járnoxíð (E172) Svart járnoxíð (E172).
English: What you need to know before you use Briviact 3.
Icelandic: Upplýsingar um Briviact og við hverju það er notað Áður en byrjað er að nota Briviact Hvernig nota á Briviact
English: Recommended maintenance dose
Icelandic: Getnaðarvarnartöflur til inntöku
English: Brivaracetam did not show any dependence potential in rats.
Icelandic: Í rottum sýndi brivaracetam ekki nokkur ávanabindandi áhrif.
English: Briviact 10 mg/ml oral solution brivaracetam
Icelandic: Briviact 10 mg/ml mixtúra, lausn brivaracetam
English: There were no adverse effects on CNS function, neuropathological and brain histopathological examination.
Icelandic: Engar aukaverkanir voru á starfsemi miðtaugakerfis eða komu fram við taugameinafræðilegar og vefjameinafræðilegar rannsóknir.
English: Dose adjustments are recommended for patients with hepatic impairment (see section
Icelandic: Skammtaaðlögun er ráðlögð hjá sjúklingum með skerta lifrarstarfsemi (sjá kafla 4.2).
English: NA 9.2
Icelandic: Tafla 2:
English: Each film-coated tablet contains 75 mg brivaracetam.
Icelandic: Hver filmuhúðuð tafla inniheldur 75 mg brivaracetam.
English: Briviact 10 mg tablets brivaracetam
Icelandic: Briviact 10 mg töflur brivaracetam
English: Not Applicable.
Icelandic: Á ekki við.
English: From the pooled open-label safety and PK studies in adjunctive therapy, 149 children have received brivaracetam, of whom 116 have been treated for ≥6 months, 107 for ≥12 months, 58 for ≥24 months, and 28 for ≥36 months.
Icelandic: Þar af fengu 116 meðferð í ≥6 mánuði, 107 í≥12 mánuði, 58 í≥24 mánuði og 28 í≥36 mánuði.
English: Briviact 75 mg film-coated tablets
Icelandic: Briviact 75 mg filmuhúðaðar töflur
English: The 10 ml oral syringe has only one graduation in steps of 0.25 ml.
Icelandic: Á 10 ml munngjafarsprautunni táknar hvert strik á kvarðanum 0,25 ml.
English: Adverse reactions from clinical trials
Icelandic: Aukaverkanir úr klínískum rannsóknum
English: No clinical data are available in neonates.
Icelandic: Engar klínískar upplýsingar eru fyrirliggjandi varðandi nýbura.
English: Briviact 25 mg tablets brivaracetam
Icelandic: Briviact 25 mg töflur brivaracetam
English: Intravenous bolus: may be administered directly without dilution Intravenous infusion: may be administered over 15 minutes in a compatible diluent
Icelandic: Innrennsli: má gefa á 15 mínútum í samrýmanlegum þynningarvökva
English: Each film-coated tablet contains 25 mg brivaracetam.
Icelandic: Hver filmuhúðuð tafla inniheldur 25 mg brivaracetam.