FrancophonIA/ELRC3.0 huggingface dataset:
English: The following additional adverse reactions have been observed with Prometax transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Icelandic: Að auki hefur verið greint frá eftirfarandi aukaverkunum við notkun á Prometax forðaplástrum: óráði, hita, minnkaðri matarlyst, þvagleki (algengar), skynhreyfiofvirkni (sjaldgæfar), roði, ofsakláði, blöðrumyndun, ofnæmishúðbólga (tíðni ekki þekkt).
English: Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours.
Icelandic: Hver forðaplástur losar 13,3 mg af rivastigmini á 24 klst.
English: There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer's disease.
Icelandic: Notkun Prometax á ekki við hjá börnum við meðferð við Alzheimerssjúkdómi.
English: Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine.
Icelandic: Hver ml inniheldur rivastigminhýdrógentartrat sem jafngildir 2 mg af rivastigmini.
English: • to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8);
Icelandic: handa sjúklingum sem hafa sjúkan sínushnút eða aðrar leiðslutruflanir (leiðslurof í gáttum eða niður í slegla) (sjá kafla 4.8);
English: Slovenská republika Sandoz d.d.
Icelandic: Slovenská republika Sandoz d.d. organizačná zložka Tel:
English: ADAS-cog scores: A negative difference in DLSM indicates greater improvement in Prometax 15 cm as compared to Prometax 10 cm
Icelandic: á DLSM bendir til meiri bætingar hjá þeim sem notuðu Prometax 15 cm samanborið við Prometax 10 cm
English: Filling the syringe
Icelandic: Sprautan fyllt
English: • Problems with your heartbeat such as fast or slow heartbeat
Icelandic: Hjartsláttartruflanir, t.d. hraður eða hægur hjartsláttur
English: Rivastigmine may cause increased gastric acid secretions.
Icelandic: Hinsvegar getur notkun rivastigmin plásturs leitt til ofnæmissnertihúðbólgu.
English: Caution when Prometax Patch is given together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions).
Icelandic: Prometax forðaplástur er notaður ásamt beta-blokkum (lyf eins og atenólól notuð við háþrýstingi, hjartaöng og öðrum hjartasjúkdómum).
English: Transdermal patch Novartis Pharma GmbH Roonstraße 25
Icelandic: Mixtúra, lausn Novartis Pharma GmbH Roonstraße 25
English: Rivastigmine in vivo release rates per 24 h
Icelandic: Losunarhraði rivastigmins in vivo á hverjum 24 klst.
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with Prometax in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Icelandic: Í töflu 3 kemur fram fjöldi og hlutfall sjúklinga sem sýndu fyrirfram skilgreindar aukaverkanir sem gætu endurspeglað versnun einkenna Parkinsonsveiki í klínísku rannsókninni sem gerð var á notkun
English: - The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose,
Icelandic: - Önnur innihaldsefni eru hýprómellósa, magnesíumsterat, örkristölluð sellulósa, kísilkvoða,
English: Mean change at week 24  SD -0.6  6.4 p-value versus placebo
Icelandic: Meðaltalsbreyting eftir 24 vikur  staðalfrávik p-gildi samanborið við lyfleysu 0,005 ADCS-CGIC
English: Other side effects seen with Prometax capsules or oral solution and which may occur with the patch:
Icelandic: Aðrar aukaverkanir sem komið hafa fram við notkun Prometax forðaplástra og gætu komið fram við notkun harðra hylkja:
English: • The patch should not be exposed to any external heat sources (e.g. excessive sunlight, saunas,
Icelandic: Plásturinn má ekki verða fyrir hita í langan tíma frá neinum utanaðkomandi hitagjöfum (t.d.
English: Prometax 4.6 mg/24 h transdermal patch Prometax 9.5 mg/24 h transdermal patch Prometax 13.3 mg/24 h transdermal patch rivastigmine
Icelandic: Prometax 4,6 mg/24 klst. forðaplástur Prometax 9,5 mg/24 klst. forðaplástur Prometax 13,3 mg/24 klst. forðaplástur
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine.
Icelandic: Hvert hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 1,5 mg af rivastigmini.
English: • The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
Icelandic: Þrýsta skal plástrinum þétt að húðinni, með lófanum, í að minnsta kosti 30 sekúndur þar til brúnirnar festast vel.
English: • A patient on a dose of 12 mg/day oral rivastigmine can be switched to 9.5 mg/24 h transdermal patches.
Icelandic: Hjá sjúklingum sem nota 12 mg/sólarhring af rivastigmini til inntöku má skipta yfir í 9,5 mg/24 klst. forðaplástur
English: - Prometax 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “ENA 713 4,5 mg” on the body.
Icelandic: - Prometax 4,5 mg hörð hylki, sem innihalda beinhvítt til ljósgulleitt þurrefni, eru með rauðri hettu og rauðum bol, með hvítri áletrun „ENA 713 4,5 mg“ á bolnum.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 6.0 mg rivastigmine.
Icelandic: Hvert hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 6,0 mg af rivastigmini.
English: Very rare (may affect up to 1 in 10,000 people)
Icelandic: Mjög sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum)
English: Prometax 15 cm
Icelandic: Prometax 15 cm N = 265
English: Headache, syncope, dizziness
Icelandic: Mixtúra, lausn
English: • Renal impairment: No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Icelandic: Ekki er nauðsynlegt að breyta skömmtum hjá sjúklingum með skerta nýrnastarfsemi (sjá kafla 5.2).
English: However, Prometax may be used in this patient population and close monitoring is necessary.
Icelandic: Prometax hjá þessum sjúklingum ef haft er náið eftirlit með þeim.
English: 1 capsule contains 6.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
Icelandic: 1 hylki inniheldur 6,0 mg af rivastigmini sem rivastigminhýdrógentartrat.
English: - Prometax 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “ENA 713 6 mg” on the body.
Icelandic: - Prometax 6,0 mg hörð hylki, sem innihalda beinhvítt til ljósgulleitt þurrefni, eru með rauðri hettu og appelsínugulum bol, með rauðri áletrun „ENA 713 6 mg“ á bolnum.
English: As suggested by compartmental modelling, 9.5 mg/24 h transdermal patches exhibited exposure similar to that provided by an oral dose of 12 mg/day.
Icelandic: Í samræmi við hólfalíkan er útsetning eftir notkun Prometax 9,5 mg/24 klst. forðaplástra áþekk útsetningu eftir inntöku 12 mg/sólarhring.
English: 1 capsule contains 1.5 mg rivastigmine present as rivastigmine hydrogen tartrate.
Icelandic: 1 hylki inniheldur 1,5 mg af rivastigmini sem rivastigminhýdrógentartrat.
English: • The recommended usual daily dose is Prometax 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h.
Icelandic: Ef lyfið þolist vel og eingöngu eftir að minnsta kosti sex mánaða meðferð með 9,5 mg/24 klst. getur læknirinn sem stjórnar meðferðinni ákveðið að auka skammtinn í 13,3 mg/24 klst.
English: Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “ENA 713 4,5 mg” on body.
Icelandic: Beinhvítt eða ljósgulleitt þurrefni í hylki með rauðri hettu og rauðum bol, með hvítri áletrun „ENA 713 4,5 mg“ á bolnum.
English: • A patient on a dose of 6 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Icelandic: Hjá sjúklingum sem nota 6 mg/sólarhring af rivastigmini til inntöku má skipta yfir í 4,6 mg/24 klst. forðaplástur.
English: Prometax 15 cm2
Icelandic: Prometax 15 cm2 Prometax 10 cm n Meðaltal n Meðaltal
English: • A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Icelandic: Hjá sjúklingum sem nota 3 mg/sólarhring af rivastigmini til inntöku má skipta yfir í 4,6 mg/24 klst. forðaplástur.
English: Restlessness
Icelandic: Lystarleysi
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine.
Icelandic: Hvert hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 4,5 mg af rivastigmini.
English: • Hepatic impairment: Patients with clinically significant hepatic impairment may experience more adverse reactions.
Icelandic: Vera má að sjúklingar með klínískt marktækt skerta lifrarstarfsemi fái frekar aukaverkanir.
English: Caution when Prometax is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions).
Icelandic: Prometax er tekið ásamt beta-blokkum (lyf eins og atenólól notuð við háþrýstingi, hjartaöng og öðrum hjartasjúkdómum).
English: 1 capsule contains 4.5 mg rivastigmine present as rivastigmine hydrogen tartrate.
Icelandic: 1 hylki inniheldur 4,5 mg af rivastigmini sem rivastigminhýdrógentartrat.
English: Sodium benzoate Citric acid
Icelandic: Natríumbenzoat Sítrónusýra
English: Prometax 1.5 mg hard capsules rivastigmine
Icelandic: Prometax 1,5 mg hörð hylki rivastigmin
English: No study was conducted with Prometax transdermal patches in subjects with hepatic impairment.
Icelandic: Prometax forðaplástrar voru ekki rannsakaðir hjá sjúklingum með skerta lifrarstarfsemi.
English: - Prometax 9.5 mg/24 h transdermal patches: Each patch releasing 9.5 mg of rivastigmine per 24 hours is 10 cm and contains 18 mg of rivastigmine.
Icelandic: Hver plástur losar 9,5 mg af rivastigmini á 24 klst., er 10 cm og inniheldur 18 mg af rivastigmini.
English: 1 capsule contains 3.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
Icelandic: 1 hylki inniheldur 3,0 mg af rivastigmini sem rivastigminhýdrógentartrat.
English: Clinical studies in dementia associated with Parkinson's disease
Icelandic: Klínískar rannsóknir á vitglöpum í Parkinsonsveiki
English: Bradykinesia
Icelandic: Brisbólga
English: Where to apply your Prometax transdermal patch
Icelandic: Hvar á að setja Prometax forðaplástur
English: • Press the patch firmly in place for at least 30 seconds using the palm of the hand.
Icelandic: Þrýstu plástrinum þétt að húðinni, í að minnsta kosti 30 sekúndur, með lófanum.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine.
Icelandic: Hvert hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 3,0 mg af rivastigmini.
English: Oral solution Novartis Pharma GmbH Roonstraße 25
Icelandic: Forðaplástur Novartis Pharma GmbH Roonstraße 25
English: Prometax 6.0 mg hard capsules rivastigmine
Icelandic: Prometax 6,0 mg hörð hylki rivastigmin
English: The European Medicines Agency has waived the obligation to submit the results of studies with Prometax in all subsets of the paediatric population in the treatment of Alzheimer's dementia and in the treatment of dementia in patients with idiopathic Parkinson's disease (see section 4.2 for information on paediatric use).
Icelandic: Lyfjastofnun Evrópu hefur fallið frá kröfu um að lagðar verði fram niðurstöður úr rannsóknum á Prometax hjá öllum undirhópum barna við meðferð við Alzheimersvitglöpum og vitglöpum hjá sjúklingum með sjálfvakta
English: • The patch should not be cut into pieces.
Icelandic: Ekki skal klippa plásturinn í sundur.
English: Prometax 4.5 mg hard capsules rivastigmine
Icelandic: Prometax 4,5 mg hörð hylki rivastigmin
English: Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on body.
Icelandic: Beinhvítt eða ljósgulleitt þurrefni í hylki með gulri hettu og gulum bol, með rauðri áletrun „ENA 713 1,5 mg“ á bolnum.
English: Medicinal product matrix
Icelandic: LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR
English: Prometax 3.0 mg hard capsules rivastigmine
Icelandic: Prometax 3,0 mg hörð hylki rivastigmin
English: How to remove your Prometax transdermal patch Gently pull at one edge of the patch to remove it slowly from the skin.
Icelandic: Togið varlega í jaðarinn á plástrinum til að fjarlægja hann hægt af húðinni.
English: • Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
Icelandic: Meltingarfæravandamál eins og ógleði eða uppköst, niðurgangur
English: The following adverse reactions have only been observed with Prometax capsules and oral solution and not in clinical studies with Prometax transdermal patches: malaise, confusion, sweating increased (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).
Icelandic: Lasleiki, ringlun, aukin svitamyndun (algengt); skeifugarnarsár, hjartaöng (mjög sjaldgæft); blæðing í meltingarvegi (koma örsjaldan fyrir); og nokkur tilfelli alvarlegra uppkasta leiddu til rofs í vélinda (tíðni ekki þekkt).
English: Contact with the eyes should be avoided after handling Prometax transdermal patches (see section 5.3).
Icelandic: Prometax forðaplástra (sjá kafla 5.3).
English: • Urinary incontinence (inability to retain adequate urine)
Icelandic: Þvagleki (vangeta til að halda í sér þvagi)
English: Baseline 265 27.5 271 25.8 Week 48 Value
Icelandic: Meðaltal grunngildis ± staðalfrávik 25,4 ± 9,9 27,4 ± 10,4 23,1 ± 10,4 22,5 ± 10,1
English: - Prometax 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “ENA 713 3 mg” on the body.
Icelandic: - Prometax 3,0 mg hörð hylki, sem innihalda beinhvítt til ljósgulleitt þurrefni, eru með appelsínugulri hettu og appelsínugulum bol, með rauðri áletrun „ENA 713 3 mg“ á bolnum.
English: Prometax 6.0 mg hard capsules
Icelandic: Prometax 6,0 mg hörð hylki
English: Worsening of Parkinson's disease, seizure, tremor, somnolence
Icelandic: Parkinsonsveiki, krampar, skjálfti, svefnhöfgi.
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase
Icelandic: Þetta umbrotsefni veldur óverulegri hömlun á acetýlkólínesterasa in vitro
English: Prometax 1.5 mg hard capsules
Icelandic: Prometax 1,5 mg hörð hylki
English: Prometax 4.5 mg hard capsules
Icelandic: Prometax 4,5 mg hörð hylki
English: Gastrointestinal haemorrhage
Icelandic: Maga- og skeifugarnarsár
English: Prometax 3.0 mg hard capsules
Icelandic: Prometax 3,0 mg hörð hylki
English: Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “ENA 713 6 mg” on body.
Icelandic: Beinhvítt eða ljósgulleitt þurrefni í hylki með rauðri hettu og appelsínugulum bol, með rauðri áletrun „ENA 713 6 mg“ á bolnum.
English: Prometax 13.3 mg/24 h transdermal patch rivastigmine
Icelandic: Prometax 13,3 mg/24 klst. forðaplástur rivastigmin
English: If you accidentally take more Prometax than you should, inform your doctor.
Icelandic: Ef tekinn er stærri skammtur af Prometax en mælt er fyrir um Segðu lækninum ef þú hefur af slysni notað meira af Prometax en þú áttir að gera.
English: • The signs of Parkinson's disease get worse - such as tremor, stiffness and shuffling
Icelandic: Parkinsonsveiki versna - svo sem skjálfti, stífleiki og sjúklingar draga fætur við göngu
English: Pruritus, erythema, urticaria, vesicles, allergic dermatitis (disseminated) Renal and urinary disorders Common
Icelandic: Kláði, ofnæmishúðbólga (útbreidd) Almennar aukaverkanir og aukaverkanir á íkomustað Algengar
English: Apply one patch per day.
Icelandic: Notið einn plástur á sólarhring.
English: Following administration of
Icelandic: EÐA ÚRGANGS VEGNA
English: Prometax 9.5 mg/24 h transdermal patch rivastigmine
Icelandic: Prometax 9,5 mg/24 klst. forðaplástur rivastigmin
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.
Icelandic: Þegar rivastigmin til inntöku og digoxin voru notuð samhliða, komu ekki fram nein óæskileg áhrif á leiðni í hjarta.
English: • Allergic reaction where the patch was used, such as blisters or inflamed skin
Icelandic: Ofnæmisviðbrögð í húð undan plástrinum svo sem blöðrumyndun eða húðbólga
English: Gastric and duodenal ulcers
Icelandic: Lifur og gall Sjaldgæfar
English: Parkinson's disease (worsening)
Icelandic: Parkinsonsveiki (versnun)
English: Gastric ulcer
Icelandic: 13. LOTUNÚMER
English: What Prometax looks like and contents of the pack Each transdermal patch is a thin patch consisting of three layers.
Icelandic: 17. EINKVÆMT AUÐKENNI - TVÍVÍTT STRIKAMERKI Á pakkningunni er tvívítt strikamerki með einkvæmu auðkenni.
English: • Stomach ulcer
Icelandic: Hjarta Algengar
English: ITT + RDO population (n=87)
Icelandic: ITT + RDO þýði
English: What Prometax looks like and contents of the pack - Prometax 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on the body.
Icelandic: - Prometax 1,5 mg hörð hylki, sem innihalda beinhvítt til ljósgulleitt þurrefni, eru með gulri hettu og gulum bol, með rauðri áletrun „ENA 713 1,5 mg“ á bolnum.
English: • Carefully remove any existing patch before putting on a new one.
Icelandic: Fjarlægðu vandlega alla plástra af húðinni áður en nýr er settur á.
English: Prometax 4.6 mg/24 h transdermal patch rivastigmine
Icelandic: Prometax 4,6 mg/24 klst. forðaplástur
English: Hepatitis, elevated liver function tests Skin and subcutaneous tissue disorders Common
Icelandic: Sýkingar af völdum sýkla og sníkjudýra Koma örsjaldan fyrir
English: No study was conducted with Prometax transdermal patches in subjects with renal impairment.
Icelandic: Prometax forðaplástrar voru ekki rannsakaðir hjá sjúklingum með skerta nýrnastarfsemi.
English: • The patch should be replaced by a new one after 24 hours.
Icelandic: Skipta skal um plástur eftir 24 klst.
English: Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “ENA 713 3 mg” on body.
Icelandic: Beinhvítt eða ljósgulleitt þurrefni í hylki með appelsínugulri hettu og appelsínugulum bol, með rauðri áletrun „ENA 713 3 mg“ á bolnum.
English: Cardiac disorders Common
Icelandic: Hjartsláttartruflanir, t.d. hægur hjartsláttur
English: If you are pregnant, the benefits of using Prometax must be assessed against the possible effects on your unborn child. Prometax should not be used during pregnancy unless clearly necessary.
Icelandic: Ef þú ert þunguð þarf að meta ávinning af notkun Prometax á móti hugsanlegum áhrifum á fóstrið.
English: • Do not store above 25°C.
Icelandic: Geymið við lægri hita en 25C.
English: • Trembling
Icelandic: Dreifing
English: Vascular disorders Very rare
Icelandic: Hjarta Mjög sjaldgæfar
English: Prometax capsules 12 mg/day
Icelandic: Prometax hylki 12 mg/sólarhring
English: BOTTLE LABEL
Icelandic: MERKIMIÐI Á TÖFLUGLASI
English: • Feeling agitated or sleepy
Icelandic: Æsingur eða syfja
English: • Trembling or feeling confused
Icelandic: Skjálfti eða ringlun
English: Specific dermal studies in pregnant animals have not been conducted.
Icelandic: Sértækar rannsóknir á notkun á húð hjá dýrum á meðgöngu hafa ekki verið framkvæmdar.
English: Prometax 13.3 mg/24 h transdermal patches: Each patch releasing 13.3 mg of rivastigmine per 24 hours is 15 cm and contains 27 mg of rivastigmine.
Icelandic: 13,3 mg af rivastigmini á 24 klst., er 15 cm og inniheldur 27 mg af rivastigmini.
English: Atrioventricular block
Icelandic: Tvíblindvika 48
English: One transdermal patch is sealed in one sachet.
Icelandic: Einungis skal nota einn plástur á sólarhring.
English: Mean baseline  SD
Icelandic: Sandoz SRL Romania
English: Mean baseline  SD Mean change at week 24  SD -0.1  9.1 p-value versus placebo * p≤0.05 versus placebo ITT: Intent-To-Treat; LOCF: Last Observation Carried Forward Based on ANCOVA with treatment and country as factors and baseline value as a covariate.
Icelandic: Meðaltalsbreyting eftir 24 vikur  staðalfrávik p-gildi samanborið við lyfleysu 0,013 p≤ 0,05 samanborið við lyfleysu
English: Care must be taken when prescribing Prometax transdermal patches:
Icelandic: Prometax forðaplástrar eru notaðir:
English: Rare (may affect up to 1 in 1,000 people) • Falling
Icelandic: Mjög sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum) •
English: Adopted at the 28-31 October 2019 PRAC
Icelandic: Samþykkt á fundi PRAC 28. - 31. október 2019
English: Iron sucrose; iron carboxymaltose; iron isomaltoside; iron dextran; sodium ferric gluconate - Arteriospasm coronary (EPITT no 19408)
Icelandic: Járn súkrósi; járn karboxýmaltósi; járn ísómaltósíð; járn dextran; natríum járnglúkónat - Slagæðakrampi í kransæðum (EPITT nr. 19408)
English: There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8).
Icelandic: Tilkynnt hefur verið um ofnæmisviðbrögð sem þróuðust yfir í Kounis-heilkenni; (bráðan ofnæmis slagæðakrampa í kransæðum) sem leitt getur til hjartadreps, sjá kafla 4.8).
English: Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions.
Icelandic: Járnlyf sem gefin eru með inndælingu geta valdið ofnæmisviðbrögðum, þ.m.t. alvarlegum og hugsanlega banvænum bráðaofnæmis-/bráðaofnæmislíkum viðbrögðum.
English: Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes.
Icelandic: Einnig hefur verið tilkynnt um ofnæmisviðbrögð eftir skammta af járnkomplexum til inndælingar sem ekki höfðu vakið viðbrögð áður.
English: Undesirable effetcs Cardiac disorders
Icelandic: Aukaverkanir Hjarta
English: Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction ………….
Icelandic: Hafðu tafarlaust samband við lækni ef þú finnur fyrir einhverjum eftirfarandi teikna eða einkenna því þau sem geta verið merki um bent til alvarlegra ofnæmisviðbrögðagða:.......... og brjóstverk sem getur verið merki um hugsanlega alvarleg ofnæmisviðbrögð sem kallast Kounis-heilkenni.
English: Special warnings and precautions for use
Icelandic: 4.4. Sérstök varnaðarorð og varúðarreglur við notkun Ofnæmisviðbrögð
English: Package leaflet
Icelandic: Kounis-heilkenni
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/580133/2019
Icelandic: P RAC vegna ræsimerkja E M A /PRA C/6 30798/2019
English: Take your next dose at the right time.
Icelandic: Taktu næsta skammt á réttum tíma.
English: Plendil with food and drink
Icelandic: Plendil með mat eða drykk
English: Your doctor will advise you how long to take your medicine.
Icelandic: Læknirinn mun ráðleggja þér hversu lengi þú átt að taka lyfið.
English: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom: Plendil
Icelandic: Austurríki, Belgía, Búlgaría, Króatía, Kýpur, Tékkland, Danmörk, Eistland, Finnland, Grikkland, Ungverjaland, Ísland, Írland, Ítalía, Lettland, Litháen, Lúxemburg, Malta, Holland, Noregur, Pólland, Portúgal, Rúmenía, Slóvakía, Spánn, Svíþjóð, Bretland:
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Icelandic: {Nafn og heimilisfang} <{sími}> <{bréfasími}> <{netfang}>
English: Your doctor may lower the dose.
Icelandic: Læknirinn gæti minnkað skammtinn.
English: Therefore, it is very important that you take the number of doses prescribed by your doctor.
Icelandic: Því er mikilvægt að þú takir þann skammtafjölda sem læknirinn ávísaði.
English: Caution is recommended especially at the start of treatment.
Icelandic: Sérstaklega er ráðlagt að gæta varúðar í upphafi meðferðar.
English: Do not use this medicine if you notice the packaging is torn or damaged.
Icelandic: Ekki skal nota lyfið ef þú tekur eftir að pakkningin er rifin eða skemmd.
English: If you stop taking this medicine your condition may return.
Icelandic: Ef þú hættir að taka lyfið geta einkennin komið aftur.