FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of paroxetine can then be adjusted based on clinical response; however, dosage above 35 mg/day is not recommended.
Icelandic: Hins vegar er ekki mælt með stærri skammti en 35 mg/dag.
English: Metabolizer (PMs).
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: Patients with a history of quinidine-, quinine-, mefloquine-induced thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome (see section 4.4).
Icelandic: Sjúklingar með sögu um blóðflagnafæð af völdum kínidíns, kíníns eða meflókíns, lifrarbólgu, bælingu beinmergs eða heilkenni sem líkist rauðum úlfum (sjá kafla 4.4).
English: • redness of the skin (erythema), excessive sweating (hyperhidrosis), loss of sensation or numbness of the face, night sweats
Icelandic: • roði í húð, mikill sviti, tilfinningaglöp eða doði í andliti, nætursviti
English: PBA is a neurological condition characterized by involuntary and uncontrollable episodes of laughing and/or crying, which don't match your emotional state or mood.
Icelandic: PBA er taugakvilli sem einkennist af ósjálfráðum og stjórnlausum hláturs og/eða grátköstum, sem samsvara ekki andlegri líðan eða skapi.
English: Frequency Adverse Reaction
Icelandic: Önnur ofnæmisviðbrögð
English: Each bottle will be contained within a carton.
Icelandic: Hvert glas er afgreitt í öskju.
English: Brick red gelatin capsule, size 1, with “DMQ / 30-10” printed in white ink on the capsule and three white bands around the circumference.
Icelandic: Dimmrautt gelhylki, stærð 1 með prentaðri áletrun „DMQ / 30-10“ í hvítu bleki á hylkinu og þremur hvítum hringjum um ummálið.
English: Contents of the pack and other information
Icelandic: Pakkningar og aðrar upplýsingar NUEDEXTA inniheldur
English: • if you are already taking medicines containing quinidine, quinine, or mefloquine.
Icelandic: ef þú notar nú þegar lyf sem innihalda kínidín, kínín eða meflókín.
English: In a drug-drug interaction study, a higher combination dose of dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) was added to paroxetine at steady state.
Icelandic: Í rannsókn á milliverkun lyfja var stærri skammtasamsetningu dextrómetorfans/kínidíns (dextrómetorfan 23 mg/kínidín 26 mg) bætt við paróxetín við stöðugt ástand.
English: Dextromethorphan
Icelandic: Dextrómetorfan
English: • you develop symptoms of an allergic reaction such as swelling of the throat or tongue, difficulty breathing, dizziness, fever, rash, or hives after taking this medicine.
Icelandic: fram koma ofnæmiseinkenni eins og bólga í hálsi eða tungu, erfiðleikar við öndun, sundl, hiti, útbrot eða kláði eftir notkun lyfsins,
English: The concomitant use of thioridazine is contraindicated (see section 4.3).
Icelandic: Mælt er gegn samhliða notkun þíóridasíns (sjá kafla 4.3).
English: Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used to increase the systemic bioavailability of dextromethorphan.
Icelandic: Kínidínsúlfat er sértækur hemill CYP2D6-háðs oxandi umbrots sem notað er til að auka aðgengi dextrómetorfans í blóðrásinni.
English: A drug-drug interaction study was conducted between a higher combination dose of dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) and memantine 20 mg/day.
Icelandic: Gerð var rannsókn á milliverkun lyfja milli stærri skammtasamsetningar dextrómetorfans/kínidíns (dextrómetorfan 23 mg/kínidín 26 mg) og memantíns 20 mg/dag.
English: Quinidine is a potent inhibitor of CYP2D6.
Icelandic: Kínidín er öflugur CYP2D6 hemill.
English: It should not be used if immunemediated thrombocytopenia from structurally related active substances including quinine and mefloquine is suspected, as cross-sensitivity can occur.
Icelandic: Ekki ætti að nota lyfið ef grunur leikur á ónæmistengdri blóðflagnafæð vegna virkra efna sem eru svipuð að uppbyggingu, meðal annars kínidín og meflókín, þar sem fram getur komið víxlnæmi.
English: INFORMATION IN BRAILLE NUEDEXTA 15 mg/9 mg
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI NUEDEXTA 15 mg/9 mg
English: NUEDEXTA should be discontinued immediately if thrombocytopenia occurs, unless the thrombocytopenia is clearly not drug-related.
Icelandic: Hætta skal notkun NUEDEXTA tafarlaust ef fram kemur blóðflagnafæð, nema ef blóðflagnafæðin sé klárlega ekki af völdum lyfsins.
English: Quinidine clearance is unaffected, although there is an increased volume of distribution that leads to an increase in the elimination half-life.
Icelandic: Úthreinsun kínidíns er óbreytt þótt hún valdi auknu dreifingarmagni sem leiðir til aukningar helmingunartíma brotthvarfs.
English: To access capsules:
Icelandic: Í fylgiseðlinum eru eftirfarandi kaflar:
English: • balance disorder, abnormal coordination, speech difficulties (dysarthria), movement dysfunction, pins and needles / tingling or numbness (paraesthesia), loss of feeling or function in the lower limbs (paraparesis), sedation
Icelandic: • truflað jafnvægisskyn, óeðlileg samhæfing, talerfiðleikar, hreyfiröskun, náladofi eða doði, skert tilfinning eða máttur í neðri útlimum, slæving
English: Alcohol
Icelandic: LYFJAFORM
English: • medicines containing quinidine, quinine, or mefloquine.
Icelandic: • lyf sem innihalda kínidín, kínín eða meflókín.
English: A drug-drug interaction study was conducted between a higher combination dose of dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) and desipramine 25 mg.
Icelandic: Gerð var rannsókn á milliverkun lyfja milli stærri skammtasamsetningar dextrómetorfans/kínidíns (dextrómetorfan 23 mg/kínidín 26 mg) og desipramíns 25 mg.
English: Brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule.
Icelandic: Hart hylki Dimmrautt gelhylki, stærð 1 með prentaðri áletrun „DMQ / 20-10“ í hvítu bleki á hylkinu.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from NUEDEXTA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Icelandic: Vega þarf og meta kosti brjóstagjafar fyrir barnið og ávinning meðferðar fyrir konuna og ákveða á grundvelli matsins hvort hætta eigi brjóstagjöf eða hætta/stöðva tímabundið meðferð með NUEDEXTA.
English: • Educational material for Healthcare Professionals (HCPs)
Icelandic: Fræðsluefni fyrir heilbrigðisstarfsfólk
English: Uncommon side effects (may affect up to 1 in 100 people)
Icelandic: (geta komið fram hjá allt að 1 af hverjum 100 einstaklingum)
English: Dose adjustment is therefore not required in mild or moderate renal impairment.
Icelandic: Ekki er þörf á skammtaaðlögun þegar um er að ræða vægt eða miðlungi skerta nýrnastarfsemi.
English: PHARMACEUTICAL FORM AND CONTENTS
Icelandic: Lyfjamisnotkun og fíkn
English: Each NUEDEXTA 23 mg/9 mg capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 23.11 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Icelandic: Hvert NUEDEXTA 23 mg/9 mg hylki inniheldur dextrómetorfan hýdróbrómíð mónóhýdrat, sem jafngildir 23,11 mg af dextrómetorfan og kínidín súlfat díhýdrati, sem jafngildir 8,69 mg af kínidíni.
English: Before treatment with Nuedexta is initiated patients must be fully evaluated to confirm the diagnosis of PBA. Central to the diagnosis are the presence of an underlying neurological condition known to cause PBA, and confirmation that the episodes of emotional expression do not reflect the patient's emotional state or mood.
Icelandic: Áður en meðferð með NUEDEXTA er hafin þarf að meta sjúklinga að fullu til að staðfesta sjúkdómsgreiningu PBA.
English: • Co-administration of a strong CYP3A4 inhibitor
Icelandic: Samtímis lyfjagjöf með öflugum CYP3A4 hemli
English: Only for NUEDEXTA 15 mg/9 mg: Blister packs consist of a PVC based clear film with aluminium foil seal and contains 13 hard capsules.
Icelandic: Þynnupakkningar eru úr glæru PVC plasti með álþynnuinnsigli og innihalda 13 hörð hylki.
English: Drug interactions with desipramine and paroxetine have been studied in controlled clinical trials with a higher dose combination of dextromethorphan/quinidine (dextromethorphan 23 mg/ quinidine 26 mg) than in this medicinal product; study results are described below.
Icelandic: Milliverkun við desipramíð og paróxetín hafa verið rannsakaðar í klínískum samanburðarrannsóknum með stærri skammtasamsetningu dextrómetorfans/kínidíns (dextrómetorfan 23 mg/ kínidín 26 mg) en er að finna í þessu lyfi.
English: MAOIs
Icelandic: VIÐAUKI
English: • medicines used to treat various heart conditions, such as diltiazem, verapamil, digoxin,
Icelandic: lyf sem notuð eru við meðferð ýmissa hjartasjúkdóma, eins og diltíasem, verapamíl, dígoxín, flekaíníð og beta-blokkar (svo sem metóprólól)
English: The effect of the combination on the patient's QTc interval should be evaluated with pre- and post-dose ECGs.
Icelandic: Meta skal áhrif samsetningarinnar á QT bil sjúklingsins með hjartalínuriti fyrir og eftir lyfjagjöf.
English: Combination with MAOIs is contraindicated (see section 4.3).
Icelandic: Samtímis notkun með mónóamínoxídasahemlum er óheimil (sjá kafla 4.3).
English: This may lead to lower, potentially subtherapeutic plasma concentrations of dextromethorphan and decreased efficacy of NUEDEXTA.
Icelandic: Þetta getur valdið minni styrk, hugsanlega minni en sem nemur lækningalegum styrk dextrómetorfans í blóðvökva, og minni verkun NUEDEXTA.
English: What NUEDEXTA looks like and contents of the pack
Icelandic: Lýsing á útliti NUEDEXTA og pakkningastærðir
English: • bone fractures (skeletal injury)
Icelandic: • beinbrot (áverkar í stoðkerfi)
English: Symptoms of serotonin syndrome include altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor.
Icelandic: Einkenni um serótónín heilkenni eru meðal annars breytt andlegt ástand, háþrýstingur, eirðarleysi, vöðvakippir, hitahækkun, aukin viðbrög, svitamyndun, hrollur og skjálfti.
English: • musculoskeletal stiffness, muscle pain (myalgia), neck pain, pain in the limbs
Icelandic: • stirðleiki í stoðkerfi, vöðvaverkur, verkur í hálsi, verkur í útlimum
English: Each NUEDEXTA 15 mg/9 mg capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 15.41 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Icelandic: Hvert NUEDEXTA 15 mg/9 mg hylki inniheldur dextrómetorfan hýdróbrómíð mónóhýdrat, sem jafngildir 15,41 mg af dextrómetorfan og kínidín súlfat díhýdrati, sem jafngildir 8,69 mg af kínidíni.
English: Use in older persons No special dose adjustment of NUEDEXTA is required in older patients.
Icelandic: Ekki er þörf á skammtaaðlögun NUEDEXTA hjá öldruðum.
English: Pack size: 60 capsules
Icelandic: 60 hylki
English: • Cardiac effects (QT prolongation) including pre-existing cardiovascular conditions and clinically significant electrolyte imbalances
Icelandic: Áhrif á hjarta (QT lenging) þar með talið hjarta- og æðasjúkdómar sem fyrir eru og klínískt marktækt ójafnvægi blóðsalta
English: NUEDEXTA 15 mg/9 mg hard capsules NUEDEXTA 23 mg/9 mg hard capsules dextromethorphan / quinidine
Icelandic: NUEDEXTA 15 mg/9 mg hörð hylki dextrómetorfan / kínidín
English: Symptoms of serotonin syndrome include agitation, high blood pressure, restlessness, muscle spasms and twitching, high body temperature, excessive sweating, shivering, and tremor.
Icelandic: Einkenni serótónínheilkennis eru m.a. aukinn æsingur, hár blóðþrýstingur, óeirð, vöðvakrampar og vöðvasamdrættir, hár líkamshiti, mikill sviti, hrollur og skjálfti,
English: Common Dizziness, Headache, Somnolence
Icelandic: sundl, höfuðverkur, svefnhöfgi
English: The quinidine component is not expected to contribute to the effectiveness of NUEDEXTA in PMs, but adverse reactions of the quinidine component are still possible.
Icelandic: Ekki er búist við því að kínidín þátturinn taki þátt í virkni NUEDEXTA hjá þeim sem eru með hæg umbrot, en samt sem áður getur kínidín þátturinn valdið aukaverkunum.
English: Other adverse reactions include ataxia, nystagmus, dystonia, blurred vision, and changes in muscle reflexes.
Icelandic: Aðrar aukaverkanir voru meðal annars hreyfiglöp, augntin, vöðvaspennutruflun, óskýr sjón og breytt viðbrögð í vöðvum.
English: Treatment of overdose
Icelandic: Meðferð við ofskömmtun
English: • nose bleeds, throat pain, excessively slow or shallow breathing (respiratory depression), runny nose, yawning
Icelandic: • blóðnasir, verkur í hálsi, óvenju hæg eða grunn öndun, nefrennsli, geispi
English: Pharmacotherapeutic group: Other nervous system drugs; ATC code: N07XX59
Icelandic: Önnur lyf með verkun á taugakerfið, ATC flokkur:
English: Thioridazine, a CYP2D6 substrates that also prolong the QT interval is contraindicated (see section 4.3).
Icelandic: Ekki má gefa tíórídasín sem er CYP2D6 hvarfefni sem lengir einnig QT bil (sjá kafla 4.3).
English: When initiating treatment with NUEDEXTA in patients at risk of QT prolongation, electrocardiographic (ECG) evaluation of the QT interval should be conducted at baseline and at 2 hours after the first dose administered in the fasted state (approximates to quinidine Tmax).
Icelandic: Þegar meðferð með NUEDEXTA er hafin hjá sjúklingum sem eru í hættu á að fá QT lengingu, skal láta fara fram mat á QT bilinu með hjartalínuriti í upphafi og tveimur klst.
English: PHARMACEUTICAL PARTICULARS
Icelandic: LYFJAFRÆÐILEGIR UPPLÝSINGAR
English: • muscle spasms
Icelandic: • skert kyngeta
English: Chest discomfort, Chest pain, Chills, Feeling hot, Gait disturbance, Influenza like illness, Pyrexia, Oxygen
Icelandic: Óþægindi fyrir brjósti, verkur fyrir brjóst, hrollur, hitatilfinning, brenglun á göngulagi, flensulík einkenni, hitasótt, minni súrefnismettun
English: NUEDEXTA 23 mg/9 mg hard capsules dextromethorphan / quinidine
Icelandic: NUEDEXTA 23 mg/9 mg hörð hylki dextrómetorfan / kínidín
English: • abdominal pain, constipation, dry mouth, wind (flatulence), stomach discomfort, vomiting
Icelandic: • kviðverkur, hægðatregða, munnþurrkur, vindgangur, óþægindi í maga, uppköst
English: Concomitant medicinal products that both prolong the QT interval and are primarily metabolised by CYP2D6 (see below) are of particular potential concern.
Icelandic: Sérstaklega skal huga að lyfjum sem notuð eru samhliða sem geta bæði lengt QT bilið og umbrotna fyrst fyrir tilstilli CYP2D6 (sjá hér á eftir).
English: Common Diarrhoea, Nausea Abdominal pain, Constipation, Dry mouth, Flatulence, Stomach discomfort, Vomiting
Icelandic: Óeðlilegar hægðir, meltingartruflanir, magabólga, vannæmi í munni, náladofi í munni, endaþarmsverkur, þurr tunga
English: Each capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 23.11 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Icelandic: Hvert hylki inniheldur dextrómetorfan hýdróbrómíð mónóhýdrat, sem jafngildir 23,11 mg af dextrómetorfani og kínidín súlfat díhýdrati, sem jafngildir 8,69 mg af kínidíni.
English: Administration of activated charcoal in conventional dose of 1 g/kg, administered every 2 to 6 hours as a slurry with 8 mL/kg of tap water may enhance the systemic elimination of quinidine; this measures should be avoided if an ileus is present.
Icelandic: fresti hrært upp í vökva með 8 ml/kg af kranavatni gæti aukið brotthvarf kínidíns úr líkamanum.
English: Non-specific symptoms, such as light-headedness, chills, fever, nausea, and vomiting, can precede or occur with thrombocytopenia.
Icelandic: Almenn og oft óljós einkenni eins og vægur svimi, hrollur, hiti, ógleði og uppköst, geta komið fram á undan eða með blóðflagnafæð.
English: If you take more NUEDEXTA than you should
Icelandic: Ef notaður er stærri skammtur en mælt er fyrir um
English: Symptoms of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, increased heart rate, hyperexcitability, and toxic psychosis.
Icelandic: Einkenni ofskömmtunar með dextrómetorfani eru meðal annars ógleði, uppköst, sljóleiki, dá, öndunarbæling, krampar, hraðsláttur, oförvun og geðrof vegna eitrunar.
English: ritonavir, saquinavir, amprenavir, fosamprenavir
Icelandic: • ferðaveiki eða hreyfiveiki, eyrnasuð
English: Liver enzyme inducers
Icelandic: Eiturverkun á lifur
English: Each capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 15.41 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Icelandic: Hvert hylki inniheldur dextrómetorfan hýdróbrómíð mónóhýdrat, sem jafngildir 15,41 mg af dextrómetorfani og kínidín súlfat díhýdrati, sem jafngildir 8,69 mg af kínidíni.
English: In a study of a combination dose of dextromethorphan 23 mg / quinidine 26 mg twice daily in 12 subjects with mild (CLCR 50-80 mL/min) or moderate (CLCR 30-50 mL/min) renal impairment (6 each) compared to 9 healthy subjects (matched in gender, age, and weight range to impaired subjects), subjects showed little difference in quinidine or dextromethorphan pharmacokinetics compared to healthy subjects.
Icelandic: eða miðlungi skerta (CLCR 30-50 ml/mín.) lifrarstarfsemi (6 í hvorum hópi) samanborið við 9 heilbrigða einstaklinga (af sama kyni, aldri og þyngdarbili og einstaklingarnir með skerta starfsemi), kom fram lítill munur á lyfjahvörfum kínidíns eða dextrómetorfans miðað við heilbrigða einstaklinga.
English: Quinidine plasma concentrations are proportional to quinidine dose.
Icelandic: Plasmaþéttni kínidíns eru í réttu hlutfalli við kínidín skammt.
English: Musculoskeletal stiffness, Myalgia, Neck pain, Pain in
Icelandic: Blóðnasir, verkur í koki og barka, öndunarbæling, nefrennsli, geispi
English: Quinidine
Icelandic: Kyn
English: Adverse reactions of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, tachycardia, hyperexcitability, and toxic psychosis.
Icelandic: Aukaverkanir við ofskömmtun með dextrómetorfani voru meðal annars ógleði, uppköst, sljóleiki, dá, öndunarbæling, flog, hraðsláttur, oförvun og geðrof vegna eitrunar.
English: Neither dextromethorphan nor quinidine induced CYP1A2, CYP2B6 or CYP3A4 in human hepatocytes at concentrations up to 4.8 µM.
Icelandic: Kínidín hamlaði CYP2D6 við helming hámarkshamlandi styrk (IC50) um minna en 0,05 µM. Hvorki dextrómetorfan né kínidín voru hvetjandi á CYP1A2, CYP2B6 eða CYP3A4 í lifrarfrumum úr mönnum við styrk allt að 4,8 µM.
English: Other signs and symptoms of overdose may include vomiting, diarrhoea, tinnitus, high-frequency hearing loss, vertigo, blurred vision, diplopia, photophobia, headache, confusion, and delirium.
Icelandic: Önnur merki um ofskömmtun eru meðal annars uppköst, niðurgangur, eyrnasuð, skert heyrn á hátíðnisviði, svimi, óskýr sjón, tvísýni, ljósfælni, höfuðverkur, ringlun og óráð.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Icelandic: Mjög sjaldgæfar Meiðsli á beinagrind
English: BOTTLE LABEL (60 hard capsules) - NUEDEXTA 23 mg/9 mg capsules
Icelandic: UPPLÝSINGAR SEM SKULU KOMA FRAM Á INNRI UMBÚÐUM ÁLETRUN Á GLASI (60 hörð hylki) - NUEDEXTA 23 mg/9 mg hylki
English: There is no relevant use of NUEDEXTA in the paediatric population for the symptomatic treatment of pseudobulbar affect.
Icelandic: Notkun NUEDEXTA á ekki við hjá börnum til meðferðar einkenna sýndarmænukylfutruflunar.
English: Nervous system disorders
Icelandic: Laktósaeinhýdrat Magnesíumsterat
English: perphenazine, aripiprazole and chlorpromazine
Icelandic: Kroskarmellósa natríum
English: The combination dose of dextromethorphan/quinidine increased steady state desipramine levels approximately 8-fold.
Icelandic: Skammtasamsetningin dextrómetorfan/kínidín jók magn desipramíns við stöðugt ástand u.þ.b. 8-falt.
English: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap. Each bottle is packed in a carton.
Icelandic: Þétt pólýetýlen (HDPE) glas með pólýprópýlen barnaöryggisloki.
English: BOTTLE LABEL (60 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
Icelandic: UPPLÝSINGAR SEM SKULU KOMA FRAM Á INNRI UMBÚÐUM ÁLETRUN Á GLASI (60 hörð hylki) - NUEDEXTA 15 mg/9 mg hylki
English: Concomitant use of CYP2D6 substrates/inhibitors
Icelandic: Samhliða notkun CYP2D6 hvarfefna/hemla
English: • medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole
Icelandic: lyf sem notuð eru við meðferð gegn sveppasýkingum, eins og ketókónasól, itrakónasól, flúkónasól
English: Driving and using machines NUEDEXTA may cause dizziness.
Icelandic: Áður en byrjað er að nota NUEDEXTA Ekki má nota NUEDEXTA
English: The supratherapeutic doses are adequate to represent quinidine exposure increases due to drug-drug interactions and organ dysfunctions.
Icelandic: Skammtarnir sem voru stærri en meðferðarskammtar voru nægilegir til að vera dæmigerðir fyrir aukningu útsetningar fyrir kínidíni vegna millilyfja milliverkana og vanvirkni líffæra.
English: • medicines used to treat bacterial infections, including tuberculosis, containing clarithromycin,
Icelandic: lyf sem notuð eru við meðferð bakteríusýkinga, meðal annast berklum, sem innihalda klaritrómýsín, telitrómýsín, erýtrómýsin og rifampicín
English: • dizziness, headache, drowsiness
Icelandic: • tvísýni, óskýr sjón
English: BOTTLE CARTON (60 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM ASKJA FYRIR GLAS (60 hörð hylki) - NUEDEXTA 15 mg/9 mg hylki
English: Quinidine at higher doses has also been associated with a lupus-like syndrome involving polyarthritis, sometimes with a positive antinuclear antibody test. Other associations include rash, bronchospasm, lymphadenopathy, haemolytic anaemia, vasculitis, uveitis, angioedema, agranulocytosis, the sicca syndrome, myalgia, elevation in serum levels of skeletal-muscle enzymes, and pneumonitis.
Icelandic: Önnur tengsl eru meðal annars útbrot, berkjukrampi, eitlastækkun, rauðalosblóðleysi, smáæðabólga, æðahjúpsbólga, ofsabjúgur, kyrningahrap, sicca-heilkenni, vöðvaverkur, hækkuð beinagrindarvöðvaensín í sermi og lungnabólga.
English: • medicines used to treat HIV infection and AIDS, such as atazanavir, indinavir, nelfinavir,
Icelandic: lyf sem notuð er við meðferð HIV-smits og eyðni, eins og atazanavír, indinavír, nelfinavír, ritónavír, sakínavír, amprenavír, fosamprenavír
English: Cardiac disorders
Icelandic: Lifrarensímvirkjar
English: • Abnormal faeces, Dyspepsia, Gastritis, Hypoaesthesia oral, Paraesthesia oral, Proctalgia, Tongue dry Hepatobiliary disorders Uncommon Increased hepatic enzymes (GGT, AST, ALT) Cholelithiasis, blood bilirubin increased, Liver function test
Icelandic: Algengar Sundl, höfuðverkur, svefnhöfgi Sjaldgæfar Truflað bragðskyn, svefnsækni, vöðvasíspenna, yfirlið, fall Truflað jafnvægisskyn, óeðlileg samhæfing, tormæli, hreyfiröskun, náladofi, helftarveiklun (paraparesis) , slæving
English: If patients experience symptoms that could indicate the occurrence of cardiac arrhythmias, e.g. syncope or palpitations, NUEDEXTA should be discontinued pending further evaluation of the patient.
Icelandic: yfirlið eða hjartsláttarónot, skal hætta notkun NUEDEXTA þar til sjúklingurinn hefur verið metinn frekar.
English: Breast-feeding
Icelandic: Prentblek
English: Capsule content Croscarmellose sodium Cellulose, microcrystalline Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate
Icelandic: Örkristallaður sellulósi Vatnsfrí kísilkvoðulausn
English: BLISTER SLEEVE (13 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
Icelandic: YTRI UMBÚÐUM YTRI ASKJA - NUEDEXTA 15 mg/9 mg hylki:
English: • distorted sense of taste (dysgeusia), sleepiness (hypersomnia), muscle spasticity, fainting
Icelandic: • truflað bragðskyn, syfja, vöðvasíspenna, yfirlið, fall
English: • fatigue
Icelandic: INNIHALDSLÝSING
English: • Summary of Product Characteristics (SmPC)
Icelandic: • lystarleysi (lystarstol)
English: Animals older than six weeks of age:
Icelandic: Dýr eldri en sex vikna:
English: ATCvet code: QP54AA05.
Icelandic: QP54AA05.
English: How to apply:
Icelandic: Hvernig á að nota:
English: Hold the pipette upright.
Icelandic: Haldið pípettunni uppréttri.
English: Do not use in cats that are suffering from concomitant disease, or are debilitated and underweight (for size and age).
Icelandic: Gefið ekki köttum sem eru með annan sjúkdóm samhliða eða eru veikburða og of léttir (miðað við stærð og aldur).