FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, 1.3% of aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6% of placebo-treated patients in these trials.
Icelandic: Í rannsóknunum var greint frá aukaverkunum á heilaæðar hjá 1,3% sjúklinga sem fengu aripíprazól í samanburði við 0,6% sjúklinga sem fengu lyfleysu.
English: Excipient with known effect: each tablet contains 66 mg of lactose (as monohydrate) and 1.87 mg of sodium.
Icelandic: Hjálparefni með þekkta verkun: hver tafla inniheldur 66 mg af mjólkursykri (sem einhýdrat) og 1,87 mg af natríumi.
English: In clinical trials with aripiprazole, there were no significant differences in the incidence rates of hyperglycaemia-related adverse reactions (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
Icelandic: Í klínískum rannsóknum með aripíprazóli var enginn marktækur munur á tíðni aukaverkana sem tengdust blóðsykurhækkun (m.a. sykursýki) eða óeðlilegum rannsóknaniðurstöðum á glúkósa samanborið við lyfleysu.
English: Excipient with known effect: each tablet contains 33 mg of lactose (as monohydrate) and 0.94 mg of sodium.
Icelandic: Hjálparefni með þekkta verkun: hver tafla inniheldur 33 mg af mjólkursykri (sem einhýdrat) og 0,94 mg af natríumi.
English: In the adolescent (13 - 17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 25.6% and 45.0%, respectively.
Icelandic: Hjá unglingum (13-17 ára) með geðklofa sem fengu 5 til 30 mg af aripíprazól í allt að 72 mánuði var tíðni lágra prólaktíngilda í sermi 25,6% hjá stúlkum (< 3 ng/ml) og 45,0% hjá drengjum (< 2 ng/ml).
English: Excipient with known effect: each tablet contains 99 mg of lactose (as monohydrate) and 2.81 mg of sodium.
Icelandic: Hjálparefni með þekkta verkun: hver tafla inniheldur 99 mg af mjólkursykri (sem einhýdrat) og 2,81 mg af natríumi.
English: Manic episodes in Bipolar I Disorder in children and adolescents Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents (10 - 17 years), who met DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a Y-MRS score ≥ 20 at baseline.
Icelandic: I Í 30-vikna rannsókn var gerður samanburður á aripíprazól og lyfleysu hjá 296 börnum og unglingum (10-17 ára), sem uppfylltu greiningarskilmerki DSM-IV fyrir geðhvarfasýki
English: • Muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.
Icelandic: vöðvastífni og svefnhöfgi eða syfja; hægari öndun, köfnunartilfinning, hár eða lágur blóðþrýstingur, óeðlilegur hjartsláttartaktur.
English: Fertility Aripiprazole did not impair fertility based on data from reproductive toxicity studies.
Icelandic: Aripíprazól hafði ekki neikvæð áhrif á frjósemi miðað við gögn úr rannsóknum á eitrunaráhrifum á æxlun.
English: Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Icelandic: Aukinn gammaglútamýl transferasi (GGT)
English: Oculogyric crisis
Icelandic: Tourette-röskun
English: Psychiatric disorders Insomnia Anxiety
Icelandic: Hægðatregða Meltingartruflanir Ógleði
English: Excipient with known effect: each orodispersible tablet contains 37 mg of lactose (as monohydrate) and 1.31 mg of sodium.
Icelandic: Hjálparefni með þekkta verkun: hver munndreifitafla inniheldur 37 mg af mjólkursykri (sem einhýdrat) og 1,31 mg af natríumi.
English: In paediatric clinical trials of aripiprazole akathisia and Parkinsonism were observed.
Icelandic: Í klínískum rannsóknum með aripíprazóli hjá börnum komu fram hvíldaróþol og parkinsonsheilkenni.
English: 50 Theodor Pallady Blvd. Bucharest 032266
Icelandic: Bucharest 032266
English: Suicide attempt, suicidal ideation and completed suicide (see section 4.4) Pathological gambling Impulse-control disorders Binge eating
Icelandic: Sjálfsvígstilraunir, sjálfsvígshugmyndir og sjálfsvíg (sjá kafla 4.4)
English: • Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
Icelandic: Krampastillandi lyf við flogaveiki (svo sem karbamazepín, fenýtóín, fenóbarbítal)
English: Luxembourg/Luxemburg Zentiva, k.s.
Icelandic: Luxembourg/Luxemburg
English: • slower heart beat,
Icelandic: • hægari hjartsláttur,
English: In a long term 26-week placebo-controlled trial, the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients.
Icelandic: Í langtíma samanburðarrannsókn með lyfleysu sem stóð í 26 vikur, var tíðni utanstrýtuheilkenna 19% hjá sjúklingum sem fengu aripíprazól samanborið við 13,1% hjá sjúklingum sem fengu lyfleysu.
English: Aripiprazole group showed an improvement of 14.97 on TTS-YGTSS change from baseline to week 10 as compared with an improvement of 9.62 in the placebo group.
Icelandic: Aripíprazól leiddi til TTS-YGTSS-bata sem nam 14,97 frá grunnviðmiði til viku
English: Aripiprazole Zentiva 10 mg tablets
Icelandic: Aripiprazole Zentiva 10 mg töflur
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Zentiva 10 mg orodispersible tablets Aripiprazole Zentiva 15 mg orodispersible tablets Aripiprazole Zentiva 30 mg orodispersible tablets
Icelandic: Upplýsingar fyrir notanda lyfsins Aripiprazole Zentiva 10 mg munndreifitöflur Aripiprazole Zentiva 15 mg munndreifitöflur Aripiprazole Zentiva 30 mg munndreifitöflur aripíprazól
English: Aripiprazole Zentiva 30 mg tablets
Icelandic: Aripiprazole Zentiva 30 mg töflur
English: Aripiprazole Zentiva 5 mg tablets
Icelandic: Aripiprazole Zentiva 5 mg töflur
English: In a 52-week, placebo-controlled trial, in patients with a current manic or mixed episode of Bipolar I Disorder who achieved sustained remission (Y-MRS and MADRS total scores ≤ 12) on aripiprazole (10 mg/day to 30 mg/day) adjunctive to lithium or valproate for 12 consecutive weeks, adjunctive aripiprazole demonstrated superiority over placebo with a 46% decreased risk (hazard ratio of 0.54) in preventing bipolar recurrence and a 65% decreased risk (hazard ratio of 0.35) in preventing recurrence into mania over adjunctive placebo but failed to demonstrate superiority over placebo in preventing recurrence into depression.
Icelandic: 46% minni líkur (áhættuhlutfall 0,54) á endurkomu geðhvarfa og 65% minni líkur (áhættuhlutfall 0,35) á endurkomu oflætis miðað við viðbót með lyfleysu, en var ekki fremra lyfleysu í að fyrirbyggja endurkomu þunglyndis.
English: Aripiprazole Zentiva 30 mg tablets EU/1/15/1009/016
Icelandic: Aripiprazole Zentiva 30 mg töflur EU/1/15/1009/016
English: on aripiprazole (N = 18, or 13% of evaluable patients), compared to olanzapine (N = 45, or 33% of evaluable patients).
Icelandic: 5,6 kg þegar meðalþyngd var u.þ.b. 80,5 kg í upphafi) hjá þeim sem fengu aripíprazól (n = 18 eða 13% sjúklinga sem unnt var að meta) samanborið við þá sem fengu ólanzapín (n = 45 eða 33% sjúklinga sem unnt var að meta).
English: Recurrence prevention of manic episodes in Bipolar I Disorder For preventing recurrence of manic episodes in patients, who have been receiving aripiprazole as monotherapy or combination therapy, continue therapy at the same dose.
Icelandic: I Til þess að fyrirbyggja endurkomu oflætis hjá sjúklingum sem hafa fengið aripíprazól eitt og sér eða í samsettri meðferð, á að halda meðferð áfram með sama skammti.
English: In the pooled adolescent schizophrenia population (13 - 17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 29.5% and 48.3%, respectively.
Icelandic: Hjá heildarþýði sjúklinga með geðklofa (13-17 ára) eftir útsetningu í allt að 2 ár var tíðni lágra prólaktíngilda í sermi 29,5% hjá stúlkum (< 3 ng/ml) og 48,3% hjá drengjum (< 2 ng/ml).
English: Aripiprazole Zentiva 30 mg orodispersible tablets are white to off-white round tablets debossed ‘30' on one side and snap break line on the other side with diameter approx. 10.2 mm.
Icelandic: Aripiprazole Zentiva 30 mg munndreifitöflur eru hvítar/beinhvítar kringlóttar töflur með áletruninni „30“ á annarri hliðinni, deilistriki á hinni hliðinni og u.þ.b. 10,2 mm í þvermál.
English: Aripiprazole Zentiva 15 mg tablets
Icelandic: Aripiprazole Zentiva 15 mg töflur
English: Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Icelandic: serótónín endurupptökuhemlar (SSRI) og serótónín noradrenalín endurupptökuhemlar (SNRI), eða lyfja sem vitað er að auka þéttni aripíprazóls (sjá kafla 4.8).
English: • Antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine,
Icelandic: Þunglyndislyf eða náttúrulyf við þunglyndi og kvíða (svo sem flúoxetín, paroxetín,
English: Aripiprazole Zentiva tablets contain lactose.
Icelandic: Aripiprazole Zentiva töflur innihalda mjólkursykur.
English: In two long term trials with adolescent (13 - 17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 37.0 % and 59.4 %, respectively.
Icelandic: Í tveimur langtímarannsóknum á unglingum (13-17 ára) með geðklofa og geðhvarfasýki, sem fengu aripíprazól, var tíðni lágs prólaktíns í sermi hjá stúlkum (< 3 ng/ml) 37,0 % og drengjum (< 2 ng/ml)
English: Population pharmacokinetic evaluation has revealed no evidence of clinically significant effects from smoking on the pharmacokinetics of aripiprazole.
Icelandic: Mat á lyfjahvörfum milli hópa sýndi engin klínískt marktæk áhrif á lyfjahvörf aripíprazóls.
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0%), extrapyramidal disorder (18.4%), akathisia (16.0%), and fatigue (11.8%); and commonly (≥ 1/100,
Icelandic: I var svipað og hjá fullorðnum, fyrir utan eftirfarandi aukaverkanir: mjög algengar (≥ 1/10) svefnhöfgi (23,0%), utanstrýtueinkenni (18,4%), hvíldaróþol (16,0%) og þreyta (11,8%) og algengar (≥ 1/100, < 1/10) verkur ofarlega í kvið, aukin hjartsláttartíðni, þyngdaraukning, aukin matarlyst, vöðvakippir og hreyfitruflun.
English: Not known oedema, face oedema, pruritus, or urticaria)
Icelandic: FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN
English: Each tablet contains 5 mg of aripiprazole.
Icelandic: Hver tafla inniheldur 5 mg aripíprazól.
English: Oesophageal dysmotility and aspiration have been associated with the use of antipsychotics, including aripiprazole.
Icelandic: Hreyfingarörðugleikar í vélinda og ásvelging hafa verið tengd við notkun geðrofslyfja m.a. aripíprazól.
English: • Pain killers (such as tramadol and pethidine) used for pain relief
Icelandic: • verkjastillandi lyf (svo sem tramadól og petidín) sem notuð eru við verkjum
English: Aggression
Icelandic: Ofseyting
English: Method of administration Aripiprazole Zentiva is for oral use.
Icelandic: Lyfjagjöf Aripiprazole Zentiva er til inntöku.
English: Upon discontinuation of strong CYP3A4 inducers, the dosage of aripiprazole should be reduced to the recommended dose.
Icelandic: öflugra CYP3A4 virkja er hætt á að minnka skammta aripíprazól að ráðlögðum skammti.
English: Recurrence prevention of manic episodes in Bipolar I Disorder For preventing recurrence of manic episodes in patients who have been receiving aripiprazole as monotherapy or combination therapy, continue therapy at the same dose.
Icelandic: I Ttil þess að fyrirbyggja endurkomu oflætis hjá sjúklingum sem hafa fengið aripíprazól eitt og sér eða í samsettri meðferð, á að halda meðferð áfram með sama skammti.
English: Aripiprazole Zentiva 10 mg tablets EU/1/15/1009/006
Icelandic: Aripiprazole Zentiva 10 mg töflur EU/1/15/1009/006
English: Aripiprazole Zentiva 30 mg tablets are white to off-white capsule shaped uncoated tablets with ‘30' debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm.
Icelandic: Aripiprazole Zentiva 30 mg töflur eru hvítar/beinhvítar óhúðaðar hylkjalaga töflur með áletruninni „30“ á annarri hliðinni, deilistriki á hinni hliðinni og u.þ.b. 15,5 x 8 mm í þvermál.
English: Aripiprazole Zentiva 5 mg tablets EU/1/15/1009/001
Icelandic: Aripiprazole Zentiva 5 mg töflur EU/1/15/1009/001
English: INSTRUCTIONS ON USE
Icelandic: Þegar notkun
English: Aripiprazole Zentiva 15 mg tablets EU/1/15/1009/011
Icelandic: Aripiprazole Zentiva 15 mg töflur EU/1/15/1009/011
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate.
Icelandic: Önnur innihaldsefni eru mjólkursykureinhýdrat, örkristallaður sellulósi, krospóvídon,
English: Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3 - 5 hours after dosing.
Icelandic: Aripíprazól frásogast vel og hámarksblóðþéttni næst innan 3-5 klst. eftir gjöf.
English: Aripiprazole Zentiva 10 mg orodispersible tablets White to off-white round tablets debossed ‘10' on one side and snap break line on other side with diameter approx. 7 mm.
Icelandic: Aripiprazole Zentiva 10 mg munndreifitöflur eru hvítar/beinhvítar kringlóttar töflur með áletruninni „10“ á annarri hliðinni og brotalínu á hinni hliðinni, u.þ.b. 7 mm í þvermál.
English: Each tablet contains 10 mg of aripiprazole.
Icelandic: Hver tafla inniheldur 10 mg aripíprazól.
English: White to off-white capsule shaped uncoated tablets with ‘30' debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm.
Icelandic: Hvítar/beinhvítar kringlóttar, hylkjalaga óhúðaðar töflur með áletruninni „30“ á annarri hliðinni, deiliskoru á hinni hliðinni og u.þ.b. 15,5 x 8 mm í þvermál.
English: White to off-white round tablets debossed ‘30' on one side and snap break line on the other side with diameter approx. 10.2 mm.
Icelandic: Hvítar/beinhvítar kringlóttar töflur með sniðbrún með áletruninni „30“ á annarri hliðinni, deiliskoru á hinni hliðinni og u.þ.b. 10,2 mm í þvermál.
English: In the paediatric bipolar population (10 - 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0% and 53.3%, respectively.
Icelandic: Hjá börnum með geðhvarfasýki (10-17 ára) var tíðni lágrar sermisþéttni prolaktíns hjá stúlkum (< 3 ng/ml) 28,0% og hjá drengjum (< 2 ng/ml) 53,3%, eftir útsetningu í allt að 30 vikur.
English: Aripiprazole is excreted in human milk.A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from aripiprazole 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 aripíprazóli.
English: Pancreatitis Dysphagia
Icelandic: Meðferð ofskömmtunar
English: Tardive dyskinesia Dystonia
Icelandic: Svefnleysi Kvíði Eirðarleysi
English: Aripiprazole Zentiva 10 mg orodispersible tablets EU/1/15/1009/021
Icelandic: Aripiprazole Zentiva 10 mg munndreifitöflur EU/1/15/1009/021
English: Each tablet contains 15 mg of aripiprazole.
Icelandic: Hver tafla inniheldur 15 mg aripíprazól.
English: What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 5 mg are white to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Icelandic: Aripiprazole Zentiva 5 mg eru hvítar/beinhvítar kringlóttar, flatar óhúðaðar töflur með sniðbrún með áletruninni „5“ á annarri hliðinni, hin hliðin auð og u.þ.b. 6 mm í þvermál.
English: Aripiprazole Zentiva 15 mg tablets are white to off-white round flat bevel edged uncoated tablets with ‘15' debossed on one side and plain on the other side with diameter approx. 8.8 mm.
Icelandic: Aripiprazole Zentiva 15 mg töflur eru hvítar/beinhvítar kringlóttar, flatar óhúðaðar töflur með sniðbrún með áletruninni „15“ á annarri hliðinni, hin hliðin auð og u.þ.b. 8,8 mm í þvermál.
English: Aripiprazole Zentiva 15 mg orodispersible tablets are white to off-white round flat bevel edged tablets debossed ‘15' on one side and plain on the other side with diameter approx. 8 mm.
Icelandic: Aripiprazole Zentiva 15 mg munndreifitöflur eru hvítar/beinhvítar flatar kringlóttar töflur með sniðbrún með áletruninni „15“ á annarri hliðinni, hin hliðin auð og u.þ.b. 8 mm í þvermál.
English: Aripiprazole Zentiva 10 mg tablets are white to off-white round uncoated tablets with ‘10' debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm.
Icelandic: Aripiprazole Zentiva 10 mg töflur eru hvítar/beinhvítar kringlóttar, óhúðaðar töflur með áletruninni „10“ á annarri hliðinni, deilistriki á hinni hliðinni og u.þ.b. 8 mm í þvermál.
English: Aripiprazole Zentiva 10 mg orodispersible tablets Aripiprazole Zentiva 15 mg orodispersible tablets Aripiprazole Zentiva 30 mg orodispersible tablets aripiprazole
Icelandic: Aripiprazole Zentiva 10 mg munndreifitöflur Aripiprazole Zentiva 15 mg munndreifitöflur Aripiprazole Zentiva 30 mg munndreifitöflur
English: In a 26week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary end-point was weight gain, significantly less patients had at least 7% weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg)
Icelandic: Í fjölþjóðlegri 26 vikna, tvíblindri samanburðarrannsókn á geðklofa með 314 fullorðnum sjúklingum með ólanzapín, þar sem aðalendapunktur var þyngdaraukning, var þyngdaraukning a.m.k.
English: Aripiprazole Zentiva 30 mg orodispersible tablets EU/1/15/1009/027
Icelandic: Aripiprazole Zentiva 30 mg munndreifitöflur EU/1/15/1009/027
English: White to off-white round uncoated tablets with ‘10' debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm.
Icelandic: Hvítar/beinhvítar kringlóttar, óhúðaðar töflur með áletruninni „10“ á annarri hliðinni, deiliskoru á hinni hliðinni og u.þ.b. 8 mm í þvermál.
English: Aripiprazole Zentiva 15 mg orodispersible tablets EU/1/15/1009/024
Icelandic: Aripiprazole Zentiva 15 mg munndreifitöflur EU/1/15/1009/024
English: Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).
Icelandic: I og til þess að fyrirbyggja nýtt oflætiskast hjá fullorðnum sem fá aðallega oflæti, þegar oflæti hefur svarað meðferð með aripíprazóli (sjá kafla 5.1).
English: Dysphagia
Icelandic: Frásog
English: White to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Icelandic: Hvítar/beinhvítar kringlóttar, flatar óhúðaðar töflur með sniðbrún með áletruninni „5“ á annarri hliðinni, hin hliðin auð og u.þ.b. 6 mm í þvermál.
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis)
Icelandic: Réttstöðuþrýstingsfall Bláæðasegarek (þar með talið lungnasegarek og segamyndun í djúplægum bláæðum) Háþrýstingur
English: NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva logo
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS/
English: Slovenská republika Zentiva, a.s.
Icelandic: Zentiva, a.s.
English: Aripiprazole Zentiva orodispersible tablets contain lactose.
Icelandic: Aripiprazole Zentiva munndreifitöflur innihalda mjólkursykur.
English: Aspiration pneumonia Laryngospasm Oropharyngeal spasm
Icelandic: Röskun á hitastillingu (t.d. lágur líkamshiti, hitahækkun) Brjóstverkur
English: Prolactin
Icelandic: Prólaktín
English: The safety and efficacy of aripiprazole in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established.
Icelandic: Öryggi og verkun meðferðar aripíprazóls á geðklofa eða oflætisfasa við geðhvarfasýki
English: Orodispersible tablet
Icelandic: Tafla með aukaverkunum
English: • Antifungal medicines (such as ketoconazole, itraconazole)
Icelandic: Sveppalyf (svo sem ketókónazól, ítrakónazól)
English: Diabetes mellitus Hyperglycaemia
Icelandic: Illkynja sefunarheilkenni (Neuroleptic Malignant Syndrome)
English: Lipid parameters
Icelandic: Sístaða reðurs
English: White to off-white round flat bevel edged uncoated tablets with ‘15' debossed on one side and plain on the other side with diameter approx. 8.8 mm.
Icelandic: Hvítar/beinhvítar kringlóttar, flatar óhúðaðar töflur með sniðbrún með áletruninni „15“ á annarri hliðinni, hin hliðin auð og u.þ.b. 8,8 mm í þvermál.
English: Aripiprazole Zentiva 10 mg, 30 mg tablets: The score line is not intended for breaking the tablet.
Icelandic: Aripiprazole Zentiva 10 mg, 30 mg munndreifitöflur:
English: White to off-white round flat bevel edged tablets debossed ‘15' on one side and plain on the other side with diameter approx. 8 mm.
Icelandic: Hvítar/beinhvítar kringlóttar flatar töflur með sniðbrún með áletruninni „15“ á annarri hliðinni, hin hliðin auð og u.þ.b. 8 mm í þvermál.
English: Renal impairment
Icelandic: Þvagleki Þvagteppa
English: • Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
Icelandic: Ákveðin sýklalyf sem notuð eru sem meðferð við berklum (rífabútín, rífampísín)
English: Aripiprazole Zentiva contains sodium
Icelandic: Aripiprazole Zentiva inniheldur natrium
English: - if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.
Icelandic: - ef þú ert eldri en 70 ára gætir þú verið móttækilegri fyrir sýkingum, marblettum eða blæðingum.
English: Each one lasts 28 days.
Icelandic: Hver þeirra stendur í 28 daga.
English: It is incompatible with dextrose solutions.
Icelandic: Ekki má blanda það með dextrósa lausnum.
English: Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium
Icelandic: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgía.
English: This is because Temodal could cause hepatitis B to become active again, which can be fatal in some cases.
Icelandic: Þetta er vegna þess að Temodal getur valdið því að lifrarbólga B verði virk á ný, sem getur verið banvænt í sumum tilfellum.
English: The following information is intended for medical or health care professional use only:
Icelandic: Eftirfarandi upplýsingar eru einungis ætlaðar heilbrigðisstarfsmönnum:
English: It is therefore unlikely that you will receive more Temodal than you should.
Icelandic: Því er ólíklegt að þú fáir meira Temodal en þú átt að fá.
English: The colour of the capsule cap is different for each strength (see in the table below).
Icelandic: Liturinn á loki hylkjanna er mismunandi fyrir hvern styrkleika (sjá töfluna hér fyrir neðan).
English: How Temodal is given
Icelandic: Hvernig Temodal er gefið
English: If you accidentally get some in your eyes or nose, flush the area with water.
Icelandic: Ef þú færð það fyrir slysni í augun eða nefið skal skola svæðið með vatni.
English: Other side effects that have been reported are listed below:
Icelandic: Aðrar aukaverkanir sem greint hefur verið frá eru taldar upp hér fyrir neðan:
English: - if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
Icelandic: - ef þú hefur haft ofnæmi fyrir dacarbazíni (krabbameinslyf, stundum kallað DTIC).
English: 7 position.
Icelandic: 7-sæti.
English: - if you have ever had or might now have a hepatitis B infection.
Icelandic: - ef þú hefur verið með eða ert með lifrarbólgu B sýkingu.
English: TMZ dose (mg/m 2/day)
Icelandic: Skammtur TMZ (mg/m 2/dag)
English: Your doctor will work out your exact dose.
Icelandic: Læknirinn mun finna út nákvæman skammt fyrir þig.