FrancophonIA/ELRC3.0 huggingface dataset:
English: • light-headedness or fainting, as these could mean that the medicine is lowering your blood pressure (uncommon occurrence);
Icelandic: vægur svimi eða yfirlið, þar sem slíkt gæti bent til þess að lyfið lækki blóðþrýsting (sjaldgæft),
English: Consequently, patients receiving ADASUVE should be observed as appropriate following dosing.
Icelandic: Þar af leiðandi er viðeigandi að hafa eftirlit með sjúklingum sem fá ADASUVE að lyfjagjöf lokinni.
English: Other medicines and ADASUVE
Icelandic: Notkun annarra lyfja samhliða ADASUVE
English: Animal studies following oral administration suggest an initial preferential distribution in the lungs, brain, spleen, heart and kidney.
Icelandic: Dýrarannsóknir benda til þess að í kjölfar inntöku dreifist lyfið fyrst um lungu, heila, milta, hjarta og nýru.
English: Severe extrapyramidal reactions should be treated with anticholinergic antiparkinson medicinal products or diphenhydramine hydrochloride, and anticonvulsant therapy should be initiated as indicated.
Icelandic: Meðhöndla skal veruleg utanstrýtueinkenni með andkólínvirkum parkinsonslyfjum eða dífenhýdramínhýdróklóríði og hefja skal meðferð með krampaleysandi lyfjum samkvæmt leiðbeiningum.
English: Remove the mouthpiece from the mouth and hold breath briefly.
Icelandic: Sjúklingurinn tekur munnstykkið úr munninum og heldur í sér andanum í stutta stund.
English: • medicines like fluvoxamine, propranolol, and enoxacin and other medicines that inhibit a certain liver enzyme called “CYP450 1A2.”
Icelandic: Lyf eins og flúvoxamín, própranólól, enoxasín og önnur lyf sem hamla tilteknum lifrarensímum,
English: • have or had glaucoma (increased pressure in the eye)
Icelandic: Gláka (aukinn þrýstingur í auga)
English: The pharmacokinetic parameters of loxapine were determined in subjects on chronic, stable antipsychotic regimens following repeat administration of ADASUVE every 4 hours for a total of 3 doses (either 4.5 mg or 9.1 mg).
Icelandic: Lyfjahvarfafræðilegar breytur loxapíns voru mældar hjá sjúklingum á langvinnum, stöðugum meðferðum með geðrofslyfjum í kjölfar endurtekinnar lyfjagjafar á ADASUVE á 4 klst. fresti, samtals 3 skammtar (annaðhvort 4,5 mg eða 9,1 mg).
English: What ADASUVE looks like and contents of the pack ADASUVE 9.1 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine.
Icelandic: ADASUVE 9,1 mg innöndunarduft, afmældir skammtar samanstendur af einskammta innöndunartæki úr hvítu plasti sem inniheldur loxapín.
English: After the first dose, a second dose was administered at least 2 hours later if the agitation had not subsided sufficiently.
Icelandic: 2 klst. síðar ef ekki hafði dregið nægilega úr æsingi sjúklings.
English: Each single-dose inhaler contains 5 mg loxapine and delivers 4.5 mg of loxapine.
Icelandic: Hvert stakskammta innöndunartæki inniheldur 5 mg af loxapíni og gefur 4,5 mg af loxapíni.
English: ADASUVE is not indicated for the treatment of patients with dementia-related psychosis.
Icelandic: ADASUVE er ekki ætlað til meðferðar hjá sjúklingum með geðrof tengt vitglöpum.
English: • Availabilty of rescue medications (short acting beta agonist bronchodilator) during treatment
Icelandic: Að aðgengi skuli vera að bráðalyfjum (skammvirkum, berkjuvíkkandi beta-örvum) meðan á meðferð stendur
English: Anticholinergic activity
Icelandic: Vegna andkólínvirkni
English: A third dose was administered if needed after at least 4 hours after dose 2.
Icelandic: Þriðji skammturinn var svo gefinn eftir þörfum a.m.k.
English: The recommended initial dose of ADASUVE is 9.1 mg. As this dose cannot be reach with this presentation (ADASUVE 4.5 mg), the presentation ADASUVE 9.1 mg should be used initially.
Icelandic: Þar sem ekki er hægt að ná þeim skammti með þessum styrkleika (ADASUVE 4,5 mg) á að byrja á að nota styrkleikann ADASUVE 9,1 mg.
English: Before treatment with ADASUVE, tell your doctor or nurse if you:
Icelandic: Leitið til læknisins eða hjúkrunarfræðingsins áður en ADASUVE er notað ef eftirfarandi á við:
English: • medicines that may put you at a risk for seizures (for example, clozapine, tricyclics or SSRIs,
Icelandic: Lyf sem geta aukið hættu á krömpum (t.d. clozapín, þríhringlaga lyf eða sértækir serótónín endurupptökuhemlar (SSRI), tramadól, meflóquín)
English: Each inhaler is packaged in a sealed foil pouch.
Icelandic: Hvert innöndunartæki er í innsigluðum álpoka.
English: One
Icelandic: Einn
English: • ADASUVE may cause narrowing of the airways (bronchospasm) and may cause you to wheeze, cough, feel chest tightness or have shortness of breath.
Icelandic: ADASUVE getur valdið þrengingu í öndunarfærum (berkjukrampa) og getur valdið hvæsandi öndun, hósta, þyngslum fyrir brjósti eða mæði.
English: Risk of bronchospasm:
Icelandic: Hætta á berkjukrampa:
English: Assessment of adverse reactions from clinical study data is based on two Phase 3 and one Phase 2A short-term (24-hour) placebo-controlled clinical trials enrolling 524 adult patients with agitation associated with schizophrenia (including 27 patients with schizoaffective disorder) or bipolar disorder, treated with ADASUVE 4.5 mg (265 patients) or ADASUVE 9.1 mg (259 patients).
Icelandic: á 524 fullorðnum sjúklingum með æsing tengdan geðklofa (þ.á m. 27 sjúklingar með hvarfageðklofa) eða geðhvarfasýki sem fengu ADASUVE 4,5 mg (265 sjúklingar) eða ADASUVE 9,1 mg (259 sjúklingar).
English: ADASUVE has not been investigated in patients with other forms of lung disease.
Icelandic: Engar rannsóknir hafa verið gerðar á ADASUVE hjá sjúklingum með aðra lungnasjúkdóma.
English: Each single-dose inhaler contains 10 mg loxapine and delivers 9.1 mg of loxapine.
Icelandic: Hvert stakskammta innöndunartæki inniheldur 10 mg af loxapíni og gefur 9,1 mg af loxapíni.
English: Loxapine exposure in the first 2 hours after administration (AUC0-2h, a measure of early exposure that is relevant to the onset of therapeutic effect) was 25.6 ng*h/mL for the 4.5 mg dose and 66.7 ng*h/mL for the 9.1 mg dose in healthy subjects.
Icelandic: eftir gjöf (AUC0-2h, mæling á fyrstu útsetningu sem tengist því hvenær verkun hefst) nam 25,6 ng*klst./ml fyrir 4,5 mg skammtinn og 66,7 ng*klst./ml fyrir 9,1 mg skammtinn.
English: What ADASUVE looks like and contents of the pack ADASUVE 4.5 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine.
Icelandic: ADASUVE 4,5 mg innöndunarduft, afmældir skammtar samanstendur af einskammta innöndunartæki úr hvítu plasti sem inniheldur loxapín.
English: Concomitant administration of benzodiazepines or other hypnosedatives or respiratory depressants may be associated with excessive sedation and respiratory depression or respiratory failure.
Icelandic: Samhliða gjöf benzódíazepína eða annarra róandi lyfja eða öndunarbælandi lyfja tengist hugsanlega of mikilli róun, öndunarbælingu eða öndunarbilun.
English: Change at 2 hr post dose
Icelandic: Upphafsgildi Breyting 2 klst.
English: The extent of the excretion of loxapine or its metabolites in human milk is not known.
Icelandic: Ekki er vitað hvort loxapín eða umbrotsefni þess skiljast út í brjóstamjólk.
English: With chronic oral administration of loxapine, the reported adverse reactions include sedation and drowsiness; extrapyramidal symptoms (e.g., tremor, akathisia, rigidity, and dystonia); cardiovascular effects (e.g., tachycardia, hypotension, hypertension, orthostatic hypotension, light-headedness, and syncope); and anticholinergic effects (e.g., dry eyes, blurred vision, and urinary retention).
Icelandic: Tilkynningar um aukaverkanir við langvinna gjöf loxapíns til inntöku eru m.a. slæving og svefnhöfgi, utanstrýtueinkenni (t.d. skjálfti, hvíldaróþol, stífleiki og truflun á vöðvaspennu), áhrif á hjarta- og æðakerfi (t.d. hraðtaktur, lágþrýstingur, háþrýstingur, réttstöðuþrýstingsfall, vægur svimi og yfirlið) og andkólínvirk áhrif (t.d. augnþurrkur, þokusýn og þvagteppa).
English: OTHER
Icelandic: ÖNNUR
English: PEC Responders
Icelandic: PEC Svörun
English: Extrapyramidal symptoms (including acute dystonia) are known class effects for antipsychotics.
Icelandic: Utanstrýtueinkenni (þ.m.t. bráð truflun á vöðvaspennu) eru þekkt áhrif geðrofslyfja.
English: Seizures / convulsions
Icelandic: Flog / krampar
English: • Neuroleptic Malignant Syndrome (NMS) is a set of symptoms that can occur if you are taking antipsychotic medicines, including ADASUVE.
Icelandic: Illkynja sefunarheilkenni eru einkenni sem hugsanlega koma fram eftir notkun á geðrofslyfjum þ.m.t. ADASUVE.
English: Very common: sedation/somnolence
Icelandic: Slæving/svefnhöfgi
English: Metabolites are excreted in the urine in the form of conjugates and in the faeces unconjugated.
Icelandic: Umbrotsefni skiljast út í þvagi sem tengd umbrotsefni og ótengd í hægðum.
English: Tear open the foil pouch and remove the inhaler from the package.
Icelandic: Opnið álpokann og takið innöndunartækið úr umbúðunum.
English: These can be associated with a severe condition called neuroleptic malignant syndrome (NMS)
Icelandic: Slíkt tengist alvarlegu sjúkdómsástandi sem nefnist illkynja sefunarheilkenni.
English: For complete instructions on how to use ADASUVE see information for the healthcare professional section of the package leaflet.
Icelandic: Ítarlegar upplýsingar um notkun ADASUVE er að finna í kaflanum ætluðum heilbrigðisstarfsfólki í fylgiseðlinum.
English: Administration of ADASUVE resulted in rapid absorption of loxapine with a median time of maximum plasma concentration (Tmax) by 2 minutes.
Icelandic: Við gjöf á ADASUVE frásogaðist loxapín hratt þar sem meðaltími hámarksplasmaþéttni (Thám.) var 2 mínútur.
English: Similar changes, e.g., gynecomastia, are known in humans, but only after long-term administration of medicines causing hyperprolactinaemia.
Icelandic: Svipaðar breytingar eru þekktar hjá mönnum, t.d. brjóstastækkun hjá körlum, en einungis eftir langtíma gjöf lyfja sem auka mjólkurhormón í blóði.
English: • have or had breathing problems like asthma or other chronic lung diseases such as bronchitis or emphysema
Icelandic: Öndunarerfiðleikar eins og astmi eða aðrir langvinnir lungnasjúkdómar, s.s. berkjubólga eða lungnaþemba
English: Pharmacotherapeutic group: psycholeptics, antipsychotics; ATC code: N05AH01
Icelandic: Geðlyf, geðrofslyf; ATC flokkur:
English: ADASUVE should be used with caution in patients with a known history of extrapyramidal symptoms.
Icelandic: Gæta skal varúðar við notkun ADASUVE hjá sjúklingum með sögu um utanstrýtueinkenni.
English: If you get any of the following side effects, talk to your doctor immediately and stop taking the medicine:
Icelandic: Hafið umsvifalaust samband við lækni og hættið notkun lyfsins ef eftirfarandi aukaverkanir koma fram:
English: What you need to know before you use ADASUVE
Icelandic: Áður en byrjað er að nota ADASUVE
English: However, in placebo-controlled clinical trials in subjects with mild-to-moderate persistent asthma or moderate-to-severe COPD, adverse reactions of bronchospasm were reported very commonly.
Icelandic: Í klínískum samanburðarrannsóknum með lyfleysu hjá sjúklingum með vægan eða meðalalvarlegan langvinnan astma eða meðalalvarlega eða alvarlega langvinna lungnateppu voru tilkynningar um berkjukrampa mjög algengar.
English: Each inhaler delivers 9.1 mg loxapine.
Icelandic: Hvert innöndunartæki gefur 9,1 mg af loxapíni.
English: ADASUVE with alcohol Because ADASUVE affects the nervous system, alcohol should be avoided when using ADASUVE.
Icelandic: ADASUVE samhliða áfengi Ekki skal nota áfengi samhliða notkun á ADASUVE þar sem lyfið hefur áhrif á miðtaugakerfið.
English: ADASUVE 4.5 mg inhalation powder loxapine
Icelandic: ADASUVE 4,5 mg innöndunarduft loxapín
English: Therefore, the risk of metabolic interactions caused by an effect on an individual isoform is limited.
Icelandic: Því er takmörkuð hætta á umbrotamilliverkunum vegna verkunar á stök ísóensím.
English: ADASUVE 9.1 mg inhalation powder loxapine
Icelandic: ADASUVE 9,1 mg innöndunarduft loxapín
English: tramadol, mefloquine)
Icelandic: Berkjukrampi (þ.m.t. mæði)
English: ADASUVE is used to treat acute symptoms of mild-to-moderate agitation that may occur in adult patients who have schizophrenia or bipolar disorder.
Icelandic: ADASUVE er notað til meðhöndlunar á bráðum einkennum á vægum til miðlungsmiklum æsingi hjá fullorðnum sjúklingum með geðklofa eða geðhvarfasýki.
English: Patient should be observed during the first hour after each dose for signs and symptoms of bronchospasm.
Icelandic: Vakta skal sjúklinga fyrsta klukkutímann eftir gjöf hvers skammts með tilliti til berkjukrampa.
English: Primary endpoint was absolute change in PEC score from baseline to 2 hours following Dose 1 for both doses of ADASUVE compared with placebo.
Icelandic: eftir fyrsta skammt, í skori á PEC-kvarðanum, fyrir báðar skammtastærðir ADASUVE samanborið við lyfleysu.
English: • are an older person with dementia (loss of memory and other mental abilities).
Icelandic: Ef um aldraða sjúklinga er að ræða sem eru með vitglöp (minnistap eða aðrir andlegir kvillar).
English: Study Patients
Icelandic: Sjúklingahópa r í rannsókn
English: The recommended initial dose is 9.1 mg. After 2 hours, your doctor may prescribe a second dose after carefully considering your condition and your dose may be reduced to 4.5 mg if your doctor believes that this is a more appropriate dose to treat your condition.
Icelandic: eftir nákvæmt mat á sjúkdómsástandi og telji hann að lægri skammtur henti betur til meðhöndlunar getur hann minnkað skammtinn í 4,5 mg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Lýsing á útliti ADASUVE og pakkningastærðir
English: Each inhaler delivers 4.5 mg loxapine.
Icelandic: Hvert innöndunartæki gefur 4,5 mg af loxapíni.
English: Mild hypotension was reported in short-term (24-hour), placebo-controlled trials in agitated patients administered ADASUVE.
Icelandic: Tilkynnt var um lágþrýsting í skammvinnum (24 klst.) samanburðarrannsóknum með lyfleysu hjá sjúklingum með æsing sem fengu ADASUVE.
English: Date of first authorisation: 20 February 2013 Date of latest renewal:
Icelandic: Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: Inclusion in Study 004-302 required a diagnosis of bipolar disorder (current episode manic or mixed).
Icelandic: Gerð var krafa um greiningu á geðhvarfasýki (í geðhæðarlotu eða með blönduð einkenni) fyrir þátttöku í rannsókn 004-302.
English: Because of anticholinergic action, ADASUVE should be used cautiously in patients with glaucoma or a tendency to urinary retention, particularly with concomitant administration of anticholinergic-type antiparkinson medicinal products.
Icelandic: ADASUVE skal nota lyfið með varúð hjá sjúklingum með gláku eða tilhneigingu til þvagteppu, sér í lagi við samhliða gjöf andkólínvirkra parkinsonslyfja.
English: Renal failure following oral loxapine overdosage has also been reported.
Icelandic: Einnig hefur verið tilkynnt um nýrnabilun í kjölfar ofskömmtunar með loxapíni eftir inntöku.
English: These symptoms can be high fever, rigid muscles,
Icelandic: Slík einkenni eru hugsanlega mikill sótthiti, stífleiki í vöðvum, óreglulegur eða hraður hjartsláttur.
English: ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units.
Icelandic: ADASUVE 9,1 mg er afgreitt í öskju sem inniheldur 1 eða 5 einingar.
English: • ADASUVE should be used with caution in patients who are intoxicated or delirious.
Icelandic: Nota skal ADASUVE með varúð hjá sjúklingum sem eru drukknir eða með óráði.
English: Bronchospasm
Icelandic: Innöndunarduft
English: One single-dose inhaler
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: ADASUVE 4.5 mg is supplied in a carton of 1 or 5 units.
Icelandic: ADASUVE 4,5 mg er afgreitt í öskju sem inniheldur 1 eða 5 einingar.
English: # Doses Needed
Icelandic: SEM FÓLK GETUR
English: • Addtional risk minimisation measures
Icelandic: Viðbótaraðgerðir til að lágmarka áhættu
English: In a supportive Phase 2 single dose study enrolling a total of 129 patients with schizophrenia and schizoaffective disorder the decrease in PEC change after 2 hours was -5.0 for placebo, -6.7 for ADASUVE 4.5 mg, and -8.6 (p<0.001) for ADASUVE 9.1 mg.
Icelandic: -5,0 með lyfleysu, -6,7 með ADASUVE 4,5 mg og -8,6 (p<0,001) með ADASUVE 9,1 mg.
English: Cardiovascular
Icelandic: Geðklofi
English: • The indicator light turns on (green) when the tab is pulled out.
Icelandic: Gaumljósið logar í grænum lit þegar togað er í flipann.
English: Patients who have been given more ADASUVE than they should may experience any of the following symptoms: extreme tiredness or sleepiness, trouble breathing, low blood pressure, throat irritation or a bad taste in the mouth, muscle or eye movements you can't control.
Icelandic: Mikilli þreytu eða syfju, öndunarerfiðleikum, lágum blóðþrýstingi, ertingu í hálsi eða vondu bragði, stjórnlausum vöðva- eða augnhreyfingum.
English: Inhalation powder
Icelandic: UPPLÝSINGAR MEÐ BLINDRALETRI
English: • ADASUVE is provided in a sealed pouch.
Icelandic: ADASUVE er afhent í innsigluðum poka.
English: In placebo-controlled clinical trials in subjects with asthma or COPD, bronchospasm was very commonly observed.
Icelandic: Tilkynningar um berkjukrampa voru mjög algengar hjá sjúklingum með astma eða langvinna lungnateppu í klínískum samanburðarrannsóknum með lyfleysu.
English: Check with your doctor or nurse if you are not sure.
Icelandic: - Leitið til læknisins eða hjúkrunarfræðings ef þörf er á frekari upplýsingum um lyfið.
English: CGI-I Responder
Icelandic: SEM EIGA AÐ KOMA FRAM Á
English: NOTE: If the green light stays on after the patient inhales, instruct the patient to repeat steps 3-5.
Icelandic: Látið sjúkling endurtaka þrep 3-5 ef ekki slokknar á græna ljósinu eftir að sjúklingur andar að sér lyfinu.
English: Note: If the green light stays on after the patient inhales, instruct the patient to repeat steps 3 to 5.
Icelandic: Látið sjúkling endurtaka þrep 3 til 5 ef ekki slokknar á græna ljósinu eftir að sjúklingur andar að sér lyfinu.
English: • ever had muscle or eye movements you can't control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still
Icelandic: Ef óstjórnlegar vöðva- eða augnhreyfingar, skortur á samhæfingu, varanlegir vöðvasamdrættir eða eirðarleysi hafa komið fram
English: Inhalation powder, pre-dispensed
Icelandic: Innöndunarduft, afmældir skammtar
English: ADASUVE 9.1 mg inhalation powder, pre-dispensed
Icelandic: ADASUVE 9,1 mg innöndunarduft, afmældir skammtar
English: ADASUVE is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.
Icelandic: ADASUVE er ætlað til notkunar til skjótrar meðhöndlunar á vægum til miðlungsmiklum æsingi hjá fullorðnum sjúklingum með geðklofa eða geðhvarfasýki.
English: 5 single-dose inhalers
Icelandic: 5 stakskammta innöndunartæki
English: ADASUVE should not be re-administered in patients who develop any respiratory signs/symptoms (see section 4.3).
Icelandic: Ekki skal endurtaka gjöf á ADASUVE hjá sjúklingum sem fá einkenni frá öndunarfærum (sjá kafla
English: Exhale
Icelandic: Sundl
English: ADASUVE 4.5 mg inhalation powder, pre-dispensed loxapine
Icelandic: ADASUVE 4,5 mg innöndunarduft, afmældir skammtar loxapín
English: ADASUVE 9.1 mg inhalation powder, pre-dispensed loxapine
Icelandic: ADASUVE 9,1 mg innöndunarduft, afmældir skammtar loxapín
English: An updated RMP should be submitted:
Icelandic: Ítarlegri upplýsingar um ADASUVE:
English: Each inhaler is provided in a sealed, multilaminate aluminum foil pouch.
Icelandic: Hvert innöndunartæki er afgreitt í innsigluðum, lagskiptum álpokum.
English: ADASUVE is not recommended in patient populations with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions which would predispose patients to hypotension (dehydration, hypovolaemia, and treatment with antihypertensive medicinal products).
Icelandic: ADASUVE hjá sjúklingum með þekkta hjarta- og æðasjúkdóma (saga um hjartadrep eða blóðþurrðarsjúkdóm í hjarta, hjartabilun eða leiðslutruflanir), æðasjúkdóma í heila eða kvilla sem auka hættu á lágþrýstingi (vessaþurrð, blóðmagnsþurrð og meðferð með blóðþrýstingslækkandi lyfjum).
English: Pull tab
Icelandic: HEITI LYFS
English: CLINICAL PARTICULARS
Icelandic: Lýðfræðilegar upplýsingar
English: ADASUVE 9.1 mg is supplied in a carton of 1 or 5 single dose inhalers.
Icelandic: ADASUVE 9,1 mg er afgreitt í öskjum sem innihalda 1 eða 5 stakskammta innöndunartæki.
English: ADASUVE 4.5 mg inhalation powder, pre-dispensed
Icelandic: ADASUVE 4,5 mg innöndunarduft, afmældir skammtar
English: The treatment of overdosage is essentially symptomatic and supportive.
Icelandic: Ef ofskömmtun á sér stað skal veita stuðning og meðferð við einkennum.
English: irregular or fast heart rate or pulse.
Icelandic: Hjartasjúkdómar eða heilablóðfall
English: ADASUVE 4.5 mg is supplied in a carton of 1 or 5 single dose inhalers.
Icelandic: ADASUVE 4,5 mg er afgreitt í öskjum sem innihalda 1 eða 5 stakskammta innöndunartæki.
English: Decreased agitation was evident 10 minutes after Dose 1, the first assessment time, and at all subsequent assessments during the 24 hour evaluation period, for both 4.5 mg and 9.1 mg doses in both schizophrenia and bipolar disorder patients.
Icelandic: Æsingur minnkaði á augljósan hátt 10 mínútum eftir 1. skammt, við fyrsta mat og við allt mat í kjölfarið á þeim 24 klst.
English: No significant inhibition was observed.
Icelandic: Engin marktæk hömlun kom fram.
English: Becoming familiar with ADASUVE: The pictures below show the important features of ADASUVE.
Icelandic: Sjá má mikilvæga eiginleika ADASUVE á myndunum hér fyrir neðan.
English: Common: dizziness
Icelandic: 3. Útöndun
English: • already used ADASUVE and you developed symptoms of wheezing or shortness of breath
Icelandic: Ef ADASUVE hefur verið notað og einkenni um hvæsandi öndun eða mæði komu fram
English: Schizophrenia
Icelandic: Taugakerfi
English: • The indicator light automatically turns off again when the medicine is inhaled.
Icelandic: Við innöndun lyfsins slökknar sjálfkrafa á gaumljósinu.
English: Instruct the patient to:
Icelandic: Gefa skal sjúklingi eftirfarandi leiðbeiningar:
English: POUCH
Icelandic: POKI
English: What you need to know before you use ADASUVE 3.
Icelandic: Áður en byrjað er að nota ADASUVE 3. Hvernig nota á ADASUVE 4. Hugsanlegar aukaverkanir
English: PC: {number}
Icelandic: (Geðklofi).
English: Hypoventilation
Icelandic: INNIHALDSLÝSING
English: ADASUVE has not been studied in elderly patients, including those with dementia-related psychosis.
Icelandic: Engar rannsóknir hafa verið gerðar á ADASUVE hjá öldruðum sjúklingum, þ.m.t. sjúklingum með geðrof tengt vitglöpum.
English: Κύπρος Τhespis Pharmaceutical Ltd Tηλ:
Icelandic: AOP Orphan Pharmaceuticals AG HU Tel.:
English: No dosage adjustment is recommended based on smoking status.
Icelandic: Því er ekki þörf á skammtaaðlögun m.t.t. reykinga.
English: Clinically relevant QT prolongation does not appear to be associated with single and repeat doses of ADASUVE.
Icelandic: Ekki virðist vera tenging á milli stakra eða endurtekinna skammta af ADASUVE og klínískt marktækrar lengingar á QT.
English: Directions for use
Icelandic: NOTKUNARLEIÐBEININGAR
English: Caution should be exercised when ADASUVE is administered in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products known to prolong the QT interval.
Icelandic: Gæta skal varúðar þegar ADASUVE er gefið sjúklingum með þekkta hjarta- og æðasjúkdóma eða fjölskyldusögu um lengingu
English: Vascular disorders
Icelandic: Stakskammta innöndunartæki
English: They will decide how much you need.
Icelandic: Þau munu meta hversu stóran skammt þú þarft.
English: (See also section 3)
Icelandic: (Sjá einnig kafla 3)
English: This may cause bleeding.
Icelandic: Það getur orsakað blæðingar.
English: However, this finding is based on a very small sample (n=129 patients).
Icelandic: Þær niðurstöður byggjast þó á mjög litlu úrtaki (n=129 sjúklingar).
English: The most commonly reported adverse reaction in the mother is nausea (14 %).
Icelandic: Algengasta aukaverkunin sem tilkynnt var hjá móður er ógleði (14%).