FrancophonIA/ELRC3.0 huggingface dataset:
English: Titanium dioxide (E171), Yellow iron oxide (E172), Red iron oxide (E172) Gelatine
Icelandic: Hylkið sjálft Títantvíoxíð (E171) Gult járnoxíð (E172) Rautt járnoxíð (E172) Gelatín
English: Nervous system disorders Very common
Icelandic: Taugakerfi Mjög algengar Algengar
English: Nimvastid 1.5 mg (on carton label only)
Icelandic: Nimvastid 1,5 mg (aðeins á miða á öskju)
English: Pull up the edge of the foil and peel the foil off completely, 3.
Icelandic: Togið upp endann á þynnunni og flettið henni alveg af.
English: If after 3 months of maintenance dose treatment the patient's rate of decline in dementia symptoms is not altered favourably, the treatment should be discontinued.
Icelandic: Hafi ekki hægt á versnun vitglapaeinkenna eftir 3 mánaða meðferð með viðhaldsskammti skal hætta meðferðinni.
English: 14 x 1 (only for 1.5 mg), 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 tablet in OPA/Alu/PVC foil film and PET/Alu peel off foil perforated unit dose blister packs are available.
Icelandic: 14 x 1 (aðeins fyrir 1,5 mg), 28 x 1, 30 x 1, 56 x 1, 60 x 1 eða 112 x 1 tafla í OPA/ál/PVC þynnufilmu og PET/ál þynnu sem fletta má af í götuðum stakskammtaþynnupakkningum í öskju.
English: Other medicines and Nimvastid
Icelandic: Notkun annarra lyfja samhliða Nimvastid
English: There have been rare post-marketing reports of patients experiencing allergic dermatitis (disseminated) when administered rivastigmine irrespective of the route of administration (oral, transdermal).
Icelandic: Eftir markaðssetningu hefur í mjög sjaldgæfum tilvikum verið greint frá að sjúklingar hafi fengið ofnæmishúðbólgu (útbreidda) við notkun rivastigmins, óháð íkomuleið (til inntöku, um húð).
English: 14 hard capsules 28 hard capsules 30 hard capsules 56 hard capsules 60 hard capsules 112 hard capsules
Icelandic: 14 hörð hylki 28 hörð hylki 30 hörð hylki 56 hörð hylki 60 hörð hylki 112 hörð hylki
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
Icelandic: Nokkur tilvik svæsinna uppkasta leiddu til rofs á vélinda (sjá kafla 4.8).
English: Not known (frequency cannot be estimated from the available data) • Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)
Icelandic: Tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum) - Svæsin uppköst sem geta leitt til þess að gat komi á vélindað - Ofþornun (of mikið vökvatap)
English: 28 hard capsules 30 hard capsules 56 hard capsules 60 hard capsules 112 hard capsules
Icelandic: 28 hörð hylki 30 hörð hylki 56 hörð hylki 60 hörð hylki 112 hörð hylki
English: Patients with visual hallucinations
Icelandic: Sjúklingar með í meðallagi mikil vitglöp
English: Clinical studies in dementia associated with Parkinson's disease The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Icelandic: Sýnt hefur verið fram á virkni rivastigmins á vitglöp í Parkinsonsveiki, í 24 vikna fjölsetra, tvíblindri kjarnarannsókn með samanburði við lyfleysu og í 24 vikna opinni framlengingu rannsóknarinnar.
English: Extrapyramidal symptoms (including worsening of Parkinson's disease)
Icelandic: Utanstrýtueinkenni (þar á meðal versnun Parkinsonsveiki)
English: Nimvastid 4.5 mg (on carton label only)
Icelandic: Nimvastid 4,5 mg (aðeins á miða á öskju)
English: Rivastigmine may cause increased gastric acid secretions.
Icelandic: Rivastigmin getur valdið aukinni seytingu magasýru.
English: Rivastigmine should be administered twice a day, with morning and evening meals.
Icelandic: Skammtar Gefa á rivastigmin tvisvar sinnum á dag, með morgunverði og kvöldverði.
English: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia or dementia associated with Parkinson's disease.
Icelandic: Læknir sem hefur reynslu í greiningu og meðferð Alzheimersvitglapa eða vitglapa í Parkinsonsveiki á að hefja meðferðina og hafa eftirlit með henni.
English: However, Nimvastid may be used in this patient population and close monitoring is necessary.
Icelandic: Hinsvegar má nota Nimvastid hjá þessum sjúklingum ef haft er náið eftirlit með þeim.
English: Uncommon (may affect up to 1 in 100 people) • Hyperactivity (high level of activity, restlessness)
Icelandic: Mjög sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum) - Brjóstverkur - Útbrot, kláði - Flog (krampar)
English: Patients without visual hallucinations
Icelandic: Sjúklingar án ofsjóna
English: Skin and subcutaneous tissue disorders
Icelandic: Kviðverkir og meltingartruflanir
English: HDPE container: boxes of 200 or 250 hard capsules are available.
Icelandic: öskjur með 200 eða 250 hörðum hylkjum eru fáanlegar.
English: If you accidentally take more Nimvastid than you should, inform your doctor.
Icelandic: Ef tekinn er stærri skammtur af Nimvastid en mælt er fyrir um Segðu lækninum ef þú hefur af slysni notað meira af Nimvastid en þú áttir að gera.
English: • Changes in how well your liver is working
Icelandic: - Breytingar á lifrarstarfsemi
English: Insomnia Anxiety Restlessness
Icelandic: Svefnleysi Þunglyndi Ofskynjanir
English: - if you have, or have ever had, difficulties in passing urine.
Icelandic: - ef þú átt í erfiðleikum eða hefur átt í erfiðleikum með þvaglát.
English: Hepatic impairment
Icelandic: Sundl Höfuðverkur
English: Nimvastid 4.5 mg hard capsules, which contain a white to almost white powder, have a brownish red cap and brownish red body.
Icelandic: Nimvastid 4,5 mg hörð hylki sem innihalda hvítt til næstum hvítt duft eru rauðbrún með rauðbrúnu loki.
English: Nimvastid 6 mg (on carton label only)
Icelandic: Nimvastid 6 mg (aðeins á miða á öskju)
English: 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 tablet in OPA/Alu/PVC foil film and PET/Alu peel off foil perforated unit dose blister packs in a box.
Icelandic: 28 x 1, 30 x 1, 56 x 1, 60 x 1 eða 112 x 1 tafla í OPA/ál/PVC þynnufilmu og PET/ál þynnu sem fletta má af í götuðum stakskammtaþynnupakkningum í öskju.
English: 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 tablet in OPA/Alu/PVC foil film and PET/Alu peel off foil perforated unit dose blister packs in a box.
Icelandic: 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1 eða 112 x 1 tafla í OPA/ál/PVC þynnufilmu og PET/ál þynnu sem fletta má af í götuðum stakskammtaþynnupakkningum í öskju.
English: Pruritus, allergic dermatitis (disseminated)
Icelandic: Kláði, ofnæmishúðbólga (útbreidd)
English: • Dehydration (losing too much fluid)
Icelandic: - Ofvirkni (of mikil virkni, eirðarleysi)
English: ADAS-Cog Placebo
Icelandic: ADAS-Cog Lyfleysa
English: Nimvastid 3mg (on carton label only)
Icelandic: Nimvastid 3 mg (aðeins á miða á öskju)
English: Blister pack (PVC/PVDC/Alu-foil): boxes of 14 (only for 1.5 mg), 28, 30, 56, 60 or 112 hard capsules are available.
Icelandic: öskjur með 14 (aðeins fyrir 1,5 mg), 28, 30, 56, 60 eða 112 hörðum hylkjum eru fáanlegar.
English: - if you have, or have ever had, seizures.
Icelandic: - ef þú ert með eða hefur fengið krampa.
English: Excipient with known effect: Each orodispersible tablet contains 21 µg sorbitol E420.
Icelandic: Hver munndreifitafla inniheldur 21 míkróg af sorbitóli E420.
English: ANNEX I
Icelandic: A-V leiðslurof
English: Movement disorder Bradykinesia
Icelandic: Hreyfingaraskanir (movement disorder) Hæghreyfingar
English: Orodispersible tablet
Icelandic: Afbrigðilegt göngulag
English: Nimvastid 6 mg hard capsules, which contain a white to almost white powder, have a brownish red cap and orange body.
Icelandic: Nimvastid 6 mg hörð hylki sem innihalda hvítt til næstum hvítt duft eru appelsínugul með rauðbrúnu loki.
English: If you are pregnant, the benefits of using Nimvastid must be assessed against the possible effects on your unborn child. Nimvastid should not be used during pregnancy unless clearly necessary.
Icelandic: Ef þú ert þunguð þarf að meta ávinning af notkun Nimvastid á móti hugsanlegum áhrifum á fóstrið.
English: Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Icelandic: Meðferð gegn einkennum vægra til í meðallagi alvarlegra vitglapa hjá sjúklingum með sjálfvakta Parkinsonsveiki.
English: Nimvastid 3 mg hard capsules, which contain a white to almost white powder, have an orange cap and orange body.
Icelandic: Nimvastid 3 mg hörð hylki sem innihalda hvítt til næstum hvítt duft eru appelsínugul með appelsínugulu loki.
English: In healthy young men, an oral 3 mg dose decreases acetylcholinesterase (AChE) activity in CSF by approximately 40% within the first 1.5 hours after administration.
Icelandic: Hjá heilbrigðum ungum mönnum dregur 3 mg skammtur í inntöku úr acetýlkólínesterasa (AChE) virkni í heila- og mænuvökva um u.þ.b.
English: Rare (may affect up to 1 in 1,000 people)
Icelandic: Sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum)
English: - if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea.
Icelandic: - ef þú ert með einkenni frá meltingarvegi svo sem ógleði, uppköst og niðurgang.
English: Excipient with known effect: Each orodispersible tablet contains 15.75 µg sorbitol E420.
Icelandic: Hver munndreifitafla inniheldur 15,75 míkróg af sorbitóli E420.
English: Capsule content Microcrystalline cellulose Hypromellose Silica, colloidal anhydrous Magnesium stearate
Icelandic: Örkristallaður sellulósi Hýprómellósi Vatnsfrí kísilkvoða
English: - The active substance is rivastigmine hydrogen tartrate.
Icelandic: - Virka innihaldsefnið er rivastigminhýdrógentartrat.
English: Oral studies in pregnant rats and rabbits gave no indication of teratogenic potential on the part of rivastigmine.
Icelandic: Rannsóknir á lyfinu gefnu með inntöku hjá rottum og kanínum á meðgöngu, bentu ekki til þess að rivastigmin hefði fósturskemmandi áhrif.
English: Decreased appetite Dehydration
Icelandic: Minnkuð matarlyst Ofþornun
English: The efficacy of rivastigmine has been established through the use of three independent, domain specific, assessment tools which were assessed at periodic intervals during 6 month treatment periods.
Icelandic: Klínískar rannsóknir á vitglöpum í Alzheimersjúkdómi Sýnt hefur verið fram á virkni rivastigmins með því að nota þrjú óháð, vettvangssértæk matstæki, sem metin voru með reglulegu millibili á 6 mánaða meðferðartíma.
English: Nimvastid 3 mg hard capsules
Icelandic: Nimvastid 3 mg hörð hylki
English: • Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
Icelandic: - Meltingarfæravandamál eins og ógleði eða uppköst, niðurgangur
English: 28 x 1 orodispersible tablet 30 x 1 orodispersible tablet 56 x 1 orodispersible tablet 60 x 1 orodispersible tablet 112 x 1 orodispersible tablet
Icelandic: 30 x 1 munndreifitafla 56 x 1 munndreifitafla 60 x 1 munndreifitafla 112 x 1 munndreifitafla
English: White to almost white powder in a capsule with brownish red cap and brownish red body.
Icelandic: Hvítt til næstum hvítt duft í rauðbrúnu hylki með rauðbrúnu loki.
English: CARTON FOR BLISTERS AND CONTAINER, AND LABEL FOR CONTAINER
Icelandic: ASKJA Á ÖSKJUR FYRIR ÞYNNUR OG ÍLÁT OG MIÐI Á ÍLÁT
English: Hyperhydrosis Allergic dermatitis (disseminated)
Icelandic: Ofsvitnun Ofnæmishúðbólga (útbreidd)
English: Nimvastid 6 mg hard capsules
Icelandic: Nimvastid 6 mg hörð hylki
English: Check with your doctor, pharmacist or nurse if you are not sure.
Icelandic: Látið lækninn, lyfjafræðing eða hjúkrunarfræðinginn vita um allar aukaverkanir.
English: Excipient with known effect: Each orodispersible tablet contains 5.25 µg sorbitol E420.
Icelandic: Hver munndreifitafla inniheldur 5,25 míkróg af sorbitóli E420.
English: Angina pectoris
Icelandic: KRKA Pharma
English: Paediatric population
Icelandic: Aðlagaður meðferðarmunur
English: • Unusually slow movements or movements you cannot control
Icelandic: - Óeðlilega hægar eða ósjálfráðar hreyfingar
English: Hydroxypropylcellulose
Icelandic: Hýdroxýprópýlsellulósi
English: White to almost white powder in a capsule with a brownish red cap and orange body.
Icelandic: Hvítt til næstum hvítt duft í appelsínugulu hylki með rauðbrúnu loki.
English: Clinically relevant improvement in these studies was defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10% improvement on the PDS.
Icelandic: Klínískt marktæk framför í þessum rannsóknum var skilgreind fyrirfram sem minnst 4 stiga framför skv.
English: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg rivastigmine.
Icelandic: Hvert hart hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 1,5 mg af rivastigmini.
English: Balance disorder Musculoskeletal stiffness Rigors
Icelandic: Jafnvægisraskanir Stoðkerfisstirðleiki Stirðleiki
English: Excipient with known effect: Each orodispersible tablet contains 10.5 µg sorbitol E420.
Icelandic: Hver munndreifitafla inniheldur 10,5 míkróg af sorbitóli E420.
English: Nimvastid 1.5 mg hard capsules
Icelandic: Nimvastid 1,5 mg hörð hylki
English: White to almost white powder in a capsule with orange cap and orange body.
Icelandic: Hvítt til næstum hvítt duft í appelsínugulu hylki með appelsínugulu loki.
English: Cardiac disorders Rare
Icelandic: Algengar Sjaldgæfar
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4).
Icelandic: Nokkur tilvik um svæsin uppköst leiddu til rofs á vélinda (sjá kafla 4.4)
English: -J
Icelandic: K
English: Tip the tablet out onto your hand.
Icelandic: Veltið töflunni í lófann.
English: Nimvastid 4.5 mg hard capsules
Icelandic: Nimvastid 4,5 mg hörð hylki
English: Nimvastid 6 mg orodispersible tablets
Icelandic: Nimvastid 6 mg munndreifitöflur
English: Nimvastid 1.5 mg orodispersible tablets
Icelandic: Nimvastid 1,5 mg munndreifitöflur
English: Nimvastid 4.5 mg orodispersible tablets
Icelandic: Nimvastid 4,5 mg munndreifitöflur
English: • Heartburn
Icelandic: Brotthvarf
English: What you need to know before you take Nimvastid
Icelandic: Áður en byrjað er að nota Nimvastid
English: Blister:
Icelandic: Þynna:
English: 30 hard capsules: EU/1/09/525/009
Icelandic: EU/1/09/525/009
English: • Feeling agitated
Icelandic: C. AÐRAR FORSENDUR
English: As rivastigmine has a plasma half-life of about 1 hour and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose no further dose of rivastigmine should be administered for the next 24 hours.
Icelandic: Vegna þess að helmingunartími rivastigmins í plasma er u.þ.b. 1 klst. og hömlun á acetýlkólínesterasa varir í u.þ.b. 9 klst., er mælt með því þegar um er að ræða ofskömmtun án einkenna að gert sé hlé á notkun rivastigmins næsta sólarhringinn.
English: Cogwheel rigidity Dystonia
Icelandic: Algengar Algengar Algengar
English: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 6 mg rivastigmine.
Icelandic: Hvert hart hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 6 mg af rivastigmini.
English: Musculoskeletal stiffness Rigors
Icelandic: Óhófleg munnvatnsmyndun
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.
Icelandic: Þegar rivastigmin og digoxin voru notuð samhliða, komu ekki fram nein óæskileg áhrif á leiðni í hjarta.
English: Uncommon Uncommon Very rare
Icelandic: Algengar Sjaldgæfar Sjaldgæfar Tíðni ekki þekkt
English: • Too much saliva and dehydration
Icelandic: - Of mikil munnvatnsmyndun og ofþornun
English: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine.
Icelandic: Hvert hart hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 4,5 mg af rivastigmini.
English: Hallucinations Aggression, restlessness
Icelandic: - Árásargirni, eirðarleysi - Óreglulegur hjartsláttur
English: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 3 mg rivastigmine.
Icelandic: Hvert hart hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 3 mg af rivastigmini.
English: • Trembling or feeling confused
Icelandic: - Skjálfti eða ringlun
English: It has the same dosage and frequency of administration as rivastigmine capsules.
Icelandic: Skömmtun og tíðni inntöku er sú sama og hjá rivastigmin hylkjum.
English: • Stomach pain
Icelandic: Skjálfti Sundl
English: 28 hard capsules: EU/1/09/525/008
Icelandic: EU/1/09/525/008
English: Nimvastid 3 mg orodispersible tablets
Icelandic: Nimvastid 3 mg munndreifitöflur
English: Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 1.5 mg rivastigmine.
Icelandic: Hver munndreifitafla inniheldur rivastigminhýdrógentartrat sem jafngildir 1,5 mg af rivastigmini.
English: Dizziness
Icelandic: Eirðarleysi
English: 56 hard capsules: EU/1/09/525/016
Icelandic: EU/1/09/525/016
English: 112 hard capsules: EU/1/09/525/024 200 hard capsules: EU/1/09/525/050 250 hard capsules: EU/1/09/525/025
Icelandic: EU/1/09/525/050 250 hörð hylki:
English: and titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and gelatine in the capsule shell.
Icelandic: örkristallaður sellulósi, hýprómellósi, vatnsfrí kísilkvoða, magnesíumsterat innan í hylkinu og títantvíoxíð (E171), gult járnoxíð (E172), rautt járnoxíð (E172) og gelatín í hylkinu sjálfu.
English: Uncommon Uncommon Not known
Icelandic: Lifur og gall Sjaldgæfar Tíðni ekki þekkt
English: - if you have, or have ever had impaired kidney function.
Icelandic: - ef þú ert með eða hefur verið með skerta nýrnastarfsemi.
English: Cardiac arrhythmia (e.g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia) Sick sinus syndrome
Icelandic: Hjartsláttartruflanir (t.d. hægsláttur, A-V leiðslurof, gáttatif og hraðsláttur)
English: Vascular disorders Very rare
Icelandic: Meltingarfæri Mjög algengar
English: 112 hard capsules: EU/1/09/525/018 200 hard capsules: EU/1/09/525/049 250 hard capsules: EU/1/09/525/019
Icelandic: EU/1/09/525/018 200 hörð hylki:
English: 112 hard capsules: EU/1/09/525/012 200 hard capsules: EU/1/09/525/048 250 hard capsules: EU/1/09/525/013
Icelandic: EU/1/09/525/048 250 hörð hylki:
English: 30 hard capsules: EU/1/09/525/021
Icelandic: EU/1/09/525/021
English: In pregnant animals, rivastigmine and/or metabolites crossed the placenta.
Icelandic: Rivastigmin og/eða umbrotsefni þess fóru yfir fylgju hjá dýrum á meðgöngu.
English: Patients with moderate dementia (MMSE 10-17)
Icelandic: (MMSE 10-17)
English: Adjusted treatment difference p-value versus placebo
Icelandic: Aðlagaður meðferðarmunur p-gildi samanborið við lyfleysu
English: 60 hard capsules: EU/1/09/525/017
Icelandic: EU/1/09/525/017
English: Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine.
Icelandic: Hver munndreifitafla inniheldur rivastigminhýdrógentartrat sem jafngildir 4,5 mg af rivastigmini.
English: INSTRUCTIONS ON USE
Icelandic: - Notaðu
English: 30 hard capsules: EU/1/09/525/015
Icelandic: EU/1/09/525/015
English: Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 6 mg rivastigmine.
Icelandic: Hver munndreifitafla inniheldur rivastigminhýdrógentartrat sem jafngildir 6 mg af rivastigmini.
English: PC: SN:
Icelandic: HDPE ílát:
English: 56 hard capsules: EU/1/09/525/022
Icelandic: EU/1/09/525/022
English: Parkinson's disease (worsening) Salivary hypersecretion Dyskinesia
Icelandic: Parkinsonsveiki (versnun) Hæghreyfingar
English: • Chest pain
Icelandic: HEITI LYFS
English: • Feeling restless
Icelandic: - Kvíði - Eirðarleysi
English: Depression
Icelandic: Háþrýstingur
English: Hypertension
Icelandic: Lystarleysi
English: Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 3 mg rivastigmine.
Icelandic: Hver munndreifitafla inniheldur rivastigminhýdrógentartrat sem jafngildir 3 mg af rivastigmini.
English: 28 hard capsules: EU/1/09/525/014
Icelandic: EU/1/09/525/014
English: 60 hard capsules: EU/1/09/525/023
Icelandic: EU/1/09/525/023
English: Infections and infestations Very rare
Icelandic: Sjaldgæfar Mjög sjaldgæfar Koma örsjaldan fyrir
English: 28 hard capsules: EU/1/09/525/020
Icelandic: EU/1/09/525/020
English: Agitation
Icelandic: Ofsvitnun
English: Anxiety
Icelandic: Uppköst
English: Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Icelandic: Meðaltöl upplýsinga eru tilgreind til hagræðis, flokkunargreining gerð með van Elteren prófi.
English: 60 hard capsules: EU/1/09/525/011
Icelandic: EU/1/09/525/011
English: A mild eye/mucosal irritation potential of rivastigmine was identified in a rabbit study.
Icelandic: Í rannsókn hjá kanínum kom fram að rivastigmin getur hugsanlega valdið vægri ertingu í auga/slímhúð.
English: • Headache
Icelandic: Hart hylki
English: Psychiatric disorders Common
Icelandic: Heilkenni sjúks sínushnútar
English: Nausea
Icelandic: Martraðir
English: Very rare (may affect up to 1 in 10,000 people)
Icelandic: Koma örsjaldan fyrir (geta komið fyrir hjá allt að 1 af hverjum 10.000 einstaklingum)
English: S4
Icelandic: 'N41
English: Gastrointestinal disorders Very common Very common Very common Common
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Mjög algengar Algengar
English: • Nightmares
Icelandic: 13. LOTUNÚMER
English: Bradycardia Atrial Fibrillation Atrioventricular block Sick sinus syndrome
Icelandic: Klínískar rannsóknir á vitglöpum í Parkinsonsveiki
English: For all three pharmaceutical forms:
Icelandic: Fyrir öll þrjú lyfjaform:
English: If there is insufficient improvement after 3 days, the treatment can be continued for another 2 days.
Icelandic: Ef bati er ekki nægilegur eftir 3 daga má halda meðferðinni áfram í 2 daga í viðbót.
English: Camprodón, s/n°, Finca La Riba, Vall de Bianya, 17813 Girona Spain
Icelandic: Camprodón, s/n°, Finca La Riba, Vall de Bianya, 17813 Girona Spánn
English: In general the pruritis disappears within a few minutes and the local swelling within a few days.
Icelandic: Almennt hverfur kláðinn innan nokkurra mínútna og staðbundni þrotinn innan nokkurra daga.
English: total water consumption of the house at the previous day (litres)
Icelandic: heildarvatnsneysla í húsinu síðastliðinn dag (lítrar)
English: Kent CT13 9NJ
Icelandic: Kent CT13 9NJ United Kingdom
English: The administration must be continued for 5 days.
Icelandic: Halda verður gjöfinni áfram í 5 daga.
English: Dicural coated tablets should be given once a day for at least 5 days.
Icelandic: Húðaðar Dicural töflur skal gefa einu sinni á dag í að minnsta kosti 5 daga.
English: For a full list of excipients, see section 6.1
Icelandic: Heildarlisti með hjálparefnum, sjá kafla 6.1.
English: These adverse reactions were self-limiting within one or two days and did not require additional treatment.
Icelandic: Aukaverkanirnar takmörkuðu sig sjálfar innan eins til tveggja daga og kröfðust ekki frekari meðferðar.
English: Bodyweight (kg)
Icelandic: Líkamsþungi (kg)
English: The following organisms were tested and found to be susceptible to difloxacin in vitro:
Icelandic: Eftirfarandi lífverur voru rannsakaðar og reyndust næmar fyrir dífloxacíni in vitro:
English: Cattle: None.
Icelandic: Nautgripir: Engar.
English: A half-life time of 5.8 hours has been observed.
Icelandic: Helmingunartími hefur reynst vera 5,8 klst.
English: number of animals in the house X mean weight of individual animal(kg) X 100
Icelandic: fjöldi dýra í húsinu X meðalþyngd hvers dýrs (kg) X 100
English: The volume of distribution is 2.6 l/kg.
Icelandic: Dreifingarrúmmál er 2,6 l/kg.
English: D. STATEMENT OF THE MRLs which are accepted in accordance with Council Regulation (EEC) No 2377/90 and in accordance with Article 31 (3b) of Council Regulation (EEC) No 2309/93 of 22 July 1993, as amended.
Icelandic: DÝRALYFJALEIFA sem heimilað er samkvæmt reglugerð framkvæmdastjórnarinnar 2377/90 og í samræmi við 31. gr (3b) reglugerðar framkvæmdastjórnarinnar 2309/93 frá 22. júlí 1993, með breytingum.
English: Each strength of the product is available in packs of 10, 20 and 100 tablets.
Icelandic: Allir styrkleikar lyfsins eru fáanlegir í pakkningum sem innihalda 10, 20 eða 100 töflur.