FrancophonIA/ELRC3.0 huggingface dataset:
English: • cardiovascular diseases (diseases of the heart and circulation),, family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
Icelandic: • hjarta- og æðasjúkdómar (sjúkdómar í hjarta og blóðrás), fjölskyldusaga um hjarta- og æðasjúkdóma, heilaslag eða skammvinn blóðþurrð í heila, óeðlilegur blóðþrýstingur
English: Not known face oedema, pruritus, or urticaria)
Icelandic: Tíðni ekki þekkt tungubjúgur, bjúgur í andliti, kláði eða ofsakláði)
English: Hydroxypropylcellulose Magnesium stearate Indigo carmine aluminium lake (E132)
Icelandic: Hýdroxýprópýlsellulósi Magnesíumsterat Indigókarmín aluminium lake
English: Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n = 99, placebo: n = 44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Icelandic: Tourette-röskun hjá börnum (sjá kafla 4.2) Verkun arípíprasóls var rannsökuð hjá börnum með Tourettesheilkenni (arípíprasól: n = 99, lyfleysa: n = 44) í slembiraðaðri, tvíblindri, 8 vikna rannsókn með lyfleysusamanburði þar sem notaður var fastaskammtur hjá meðferðarhópum eftir þyngd á skammtabilinu 5 mg/dag til 20 mg/dag og 2 mg upphafsskammtur.
English: Based on results of a full range of standard genotoxicity tests, aripiprazole was considered non genotoxic.
Icelandic: Byggt á niðurstöðum yfirgripsmikilla staðlaðra prófa fyrir eituráhrif á erfðaefni, var álitið að aripíprazól hefði ekki eituráhrif á erfðaefni.
English: Aripiprazole Accord contains lactose
Icelandic: Aripiprazole Accord inniheldur laktósa
English: The total body clearance of aripiprazole is 0.7 ml/min/kg, which is primarily hepatic.
Icelandic: Heildarúthreinsun aripíprazóls er 0,7 ml/mín.
English: • serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
Icelandic: • serótónínheilkenni (viðbrögð sem geta valdið mikilli hamingjutilfinningu, deyfð, klunnahætti,
English: Population pharmacokinetic evaluation has revealed no evidence of clinically significant effects from smoking on the pharmacokinetics of aripiprazole.
Icelandic: Þýðismat á lyfjahvörfum á milli hópa leiddi ekki í ljós nein klínískt marktæk áhrif reykinga á lyfjahvörf arípíprazóls.
English: How to take Aripiprazole Accord
Icelandic: Hvernig geyma á Aripiprazole Accord
English: In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13-17 years), presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Icelandic: Í 6-vikna samanburðarrannsókn með lyfleysu hjá 302 unglingum með geðklofa (13-17 ára), með jákvæð eða neikvæð einkenni, kom í ljós að samanborið við lyfleysu tengdist notkun aripíprazóls tölfræðilega marktækt færri geðrofseinkennum.
English: EU/1/15/1045/011- 30 tablets EU/1/15/1045/012- 100 tablets
Icelandic: EU/1/15/1045/011- 30 töflur EU/1/15/1045/012- 100 töflur
English: (for 100's count) Do not throw away any medicines via wastewater or household waste.
Icelandic: Ekki má skola lyfjum niður í frárennslislagnir eða fleygja þeim með heimilissorpi.
English: EU/1/15/1045/017- 30 tablets EU/1/15/1045/018- 100 tablets
Icelandic: EU/1/15/1045/017- 30 töflur EU/1/15/1045/018- 100 töflur
English: If you stop taking Aripiprazole Accord
Icelandic: Ef hætt er að nota Aripiprazole Accord
English: When weak inhibitors of CYP3A4 (e.g., diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.
Icelandic: Þegar vægir CYP3A4 (t.d. diltíazem) eða CYP2D6 (t.d. escítalopram) hemlar eru notaðir samtímis aripíprazól má búast við lítilsháttar aukningu á þéttni aripíprazóls í blóðvökva.
English: Patients treated with any antipsychotics, including aripiprazole, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control (see section 4.8).
Icelandic: Fylgjast þarf náið með sjúklingum sem fá ódæmigerð virk lyf við geðrofi, þ.m.t. aripíprazól með tilliti til einkenna blóðsykurhækkunar (t.d.ofþorsti, ofsamiga, ofát og máttleysi) og glúkósu þarf að mæla reglulega hjá sjúklingum með sykursýki eða þeim sem er hætt við að fá sykursýki (sjá kafla 4.8).
English: • high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite, and feeling weak) or family history of diabetes fits (seizures) since your doctor may want to monitor you more closely
Icelandic: • ert með háan blóðsykur (sem einkennist m.a. af óhóflegum þorsta, miklum þvaglátum, aukinni matarlyst og máttleysi) eða fjölskyldusögu um sykursýki
English: Aripiprazole Accord 10 mg/ 30 mg tablets
Icelandic: Aripiprazole Accord 10 mg/ 30 mg töflur
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 aripíprazóli 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: 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 aripíprazóli og lyfleysu hjá 296 börnum og unglingum (10-17 ára), sem uppfylltu greiningarskilmerki DSM-IV fyrir geðhvarfasýki
English: Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated, and a daily dose of 30 mg is associated with a substantially higher incidence of significant adverse reactions including EPS related events, somnolence, fatigue and weight gain (see section 4.8).
Icelandic: Ekki hefur verið sýnt fram á aukna verkun með stærri skömmtum en 10 mg á sólarhring og 30 mg sólarhringsskammtur tengist töluvert hærri tíðni marktækra aukaverkana, þ.m.t.
English: Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including aripiprazole.
Icelandic: Greint hefur verið frá blóðsykurhækkun, í sumum tilvikum óhóflegri og tengdri ketóblóðsýringu eða dái eða dauðsfalli vegna vessaþurrðar (hyperosmolar coma) hjá sjúklingum sem meðhöndlaðir hafa verið með ódæmigerðum virkum lyfjum við geðrofi m.a. aripíprazól.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM/ALUMINIUM BLISTERS
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM ÁL/ÁLÞYNNUR
English: Aripiprazole Accord 5 mg tablets Aripiprazole Accord 10 mg tablets Aripiprazole Accord 15 mg tablets Aripiprazole Accord 30 mg tablets
Icelandic: Aripiprazole Accord 5 mg töflur Aripiprazole Accord 10 mg töflur Aripiprazole Accord 15 mg töflur
English: In CYP2D6 poor metabolisers, concomitant use of potent inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.When considering concomitant administration of ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient.
Icelandic: Hjá þeim sem hafa léleg CYP2D6 umbrot getur samtímis notkun á öflugum CYP3A4 hemli valdið hærri plasmaþéttni aripíprazóls samanborið við þá sem hafa yfirgripsmikið CYP2D6 umbrot.
English: To allow the start of the treatment at a low dose you can use an alternative formulation (oral solutionliquid) more suitable than Aripiprazole Accord.The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day.
Icelandic: Ef hefja á meðferð með litlum skammti má nota aðra gerð af lyfinu (mixtúru, lausn) sem hentar betur en Aripiprazole Accord.
English: CARTON FOR BOTTLE AND BOTTLE LABEL
Icelandic: YTRI UMBÚÐUM OG INNRI UMBÚÐUM ASKJA FYRIR GLAS OG ÁLETRUN GLASS
English: It has been proposed that aripiprazole's efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
Icelandic: I séu vegna örvunar að hluta á dópamín D2 og serótónín 5HT1a viðtaka og vegna hömlunar serótónín 5HT2a viðtaka.
English: Aripiprazole Accord is for oral use.
Icelandic: Lyfjagjöf Aripiprazole Accord er til inntöku.
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: 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: Talk to your doctor about the best way to feed your baby if you are taking this medicine.
Icelandic: Ræða skal við lækninn hvernig best sé að næra barnið þegar Aripiprazole Accord er tekið.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 30 mg aripíprazól.
English: Lactose monohydrate Cellulose, microcrystalline Maize starch
Icelandic: Mjólkursykureinhýdrat Sellulósi, örkristallaður
English: Each 30 mg tablet contains 177 mg lactose (as monohydrate).
Icelandic: Hver 30 mg tafla inniheldur 177 mg af mjólkursykri (sem einhýdrat) Sjá lista yfir öll hjálparefni í kafla 6.1.
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 Accord 15 mg tablets are yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Icelandic: Aripiprazole Accord 15 mg töflur eru gular töflur, u.þ.b. 7,14 mm í þvermál, kringlóttar, með sniðnum brúnum, tvíkúptar, óhúðaðar, greyptar með „A15“ á annarri hliðinni og hin hliðin er slétt.
English: Each 5 mg tablet contains 63 mg lactose (as monohydrate).
Icelandic: Hver 5 mg tafla inniheldur 63 mg af mjólkursykri (sem einhýdrat) Aripiprazole Accord 10 mg töflur
English: Each 10 mg tablet contains 59 mg lactose (as monohydrate).
Icelandic: Hver 10 mg tafla inniheldur 59 mg af mjólkursykri (sem einhýdrat) Aripiprazole Accord 15 mg töflur
English: Aripiprazole Accord 5 mg tablets
Icelandic: Aripiprazole Accord 5 mg töflur
English: In a 26-week, 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) 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: Each 15 mg tablet contains 88 mg lactose (as monohydrate).
Icelandic: Hver 15 mg tafla inniheldur 88 mg af mjólkursykri (sem einhýdrat) Aripiprazole Accord 30 mg töflur
English: Aripiprazole Accord 10 mg tablets are pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Icelandic: Aripiprazole Accord 10 mg töflur eru bleikar töflur, u.þ.b. 8,1 mm að lengd, 4,6 mm að breidd, rétthyrndar með aflíðandi brúnum, tvíkúptar, óhúðaðar, greyptar með „A10“ á annarri hliðinni og hin hliðin er slétt.
English: Aripiprazole Accord 30 mg tablets
Icelandic: Aripiprazole Accord 30 mg töflur
English: Aripiprazole Accord with food, drink and alcohol
Icelandic: Notkun Aripiprazole Accord með mat, drykk eða áfengi Þetta lyf má taka með mat eða án.
English: Pink colored, approximately 9.1 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A30” on one side and another side is plain.
Icelandic: Bleikar töflur, u.þ.b. 9,1 mm í þvermál, kringlóttar, með sniðnum brúnum, tvíkúptar, óhúðaðar, greyptar með „A30“ á annarri hliðinni og hin hliðin er slétt.
English: Yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Icelandic: Gular töflur, u.þ.b. 7,14 mm í þvermál, kringlóttar, með sniðnum brúnum, tvíkúptar, óhúðaðar, greyptar með „A15“ á annarri hliðinni og hin hliðin er slétt.
English: Aripiprazole Accord 10 mg tablets
Icelandic: Aripiprazole Accord 10 mg töflur
English: Aripiprazole Accord 15 mg tablets
Icelandic: Aripiprazole Accord 15 mg töflur
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of aripiprazole.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 10 mg aripíprazól.
English: If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
Icelandic: Leitaðu til læknisins eða lyfjafræðings ef þér finnast áhrifin af þessu lyfi vera of mikil eða of lítil.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of aripiprazole.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 5 mg aripíprazól.
English: INFORMATION IN BRAILLE Aripiprazole Accord 30 mg
Icelandic: MEÐ BLINDRALETRI Aripiprazole Accord 30 mg
English: INFORMATION IN BRAILLE Aripiprazole Accord 10 mg
Icelandic: MEÐ BLINDRALETRI Aripiprazole Accord 10 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 15 mg aripíprazól.
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Hypertension
Icelandic: Bláæðasegarek (þar með talið lungnasegarek og segamyndun í djúplægum bláæðum)
English: INFORMATION IN BRAILLE Aripiprazole Accord 5 mg
Icelandic: MEÐ BLINDRALETRI Aripiprazole Accord 5 mg
English: The safety and efficacy of Aripiprazole Accord in the treatment of schizophrenia or manic episodes inBipolar I Disorder in patients aged 65 years and older has not been established.
Icelandic: Öryggi og verkun meðferðar Aripiprazole Accord á geðklofa eða oflætisfasa við geðhvarfasýki
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1045/005- 30 tablets EU/1/15/1045/006- 100 tablets
Icelandic: EU/1/15/1045/005- 30 töflur EU/1/15/1045/006- 100 töflur
English: Blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Icelandic: Bláar töflur, u.þ.b. 8,1 mm að lengd, 4,6 mm að breidd, rétthyrndar með aflíðandi brúnum, tvíkúptar, óhúðaðar, greyptar með „A5“ á annarri hliðinni og hin hliðin er slétt.
English: Oesophageal dysmotility and aspiration have been associated with the use of antipsychotics, including aripiprazole.
Icelandic: Hreyfingarörðugleikar í vélinda og ásvelging hafa verið tengd notkun lyfja við geðrofi, m.a. aripíprazól.
English: In-use shelf life after 1st opening:
Icelandic: Geymsluþol við notkun eftir að umbúðir eru rofnar:
English: Aripiprazole Accord 5 mg tablets are blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Icelandic: Lýsing á útliti Aripiprazole Accord taflna og pakkningastærðir Aripiprazole Accord 5 mg töflur eru bláar töflur, u.þ.b. 8,1 mm að lengd, 4,6 mm að breidd, rétthyrndar með aflíðandi brúnum, tvíkúptar, óhúðaðar, greyptar með „A5“ á annarri hliðinni og hin hliðin er slétt.
English: Pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Icelandic: Bleikar töflur, u.þ.b. 8,1 mm að lengd, 4,6 mm að breidd, rétthyrndar með aflíðandi brúnum, tvíkúptar, óhúðaðar, greyptar með „A10“ á annarri hliðinni og hin hliðin er slétt.
English: What Aripiprazole Accord tablets looks like and contents of the pack
Icelandic: á Aripiprazole Accord Pakkningar og aðrar upplýsingar
English: Aripiprazole Accord 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: INFORMATION IN BRAILLE Aripiprazole Accord 15 mg 17.
Icelandic: MEÐ BLINDRALETRI Aripiprazole Accord 15 mg
English: Headache Sedation Somnolence Dizziness
Icelandic: Svefnhöfgi Sundl
English: EU/1/15/1045/001 14x1 tablets EU/1/15/1045/002 28x1 tablets EU/1/15/1045/023 49x1 tablets EU/1/15/1045/003 56x1 tablets EU/1/15/1045/004 98x1 tablets
Icelandic: EU/1/15/1045/001 14x1 tafla EU/1/15/1045/002 28x1 tafla EU/1/15/1045/023 49x1 tafla EU/1/15/1045/003 56x1 tafla EU/1/15/1045/004 98x1 tafla
English: EU/1/15/1045/019 14x1 tablets EU/1/15/1045/020 28x1 tablets EU/1/15/1045/026 49x1 tablets EU/1/15/1045/021 56x1 tablets EU/1/15/1045/022 98x1 tablets
Icelandic: EU/1/15/1045/019 14x1 tafla EU/1/15/1045/020 28x1 tafla EU/1/15/1045/026 49x1 tafla EU/1/15/1045/021 56x1 tafla EU/1/15/1045/022 98x1 tafla
English: EU/1/15/1045/013 14x1 tablets EU/1/15/1045/014 28x1 tablets EU/1/15/1045/025 49x1 tablets EU/1/15/1045/015 56x1 tablets EU/1/15/1045/016 98x1 tablets
Icelandic: EU/1/15/1045/013 14x1 tafla EU/1/15/1045/014 28x1 tafla EU/1/15/1045/025 49x1 tafla EU/1/15/1045/015 56x1 tafla EU/1/15/1045/016 98x1 tafla
English: Additional side effects in children and adolescents
Icelandic: Oflætisfasi hjá börnum og unglingum með geðhvarfasýki
English: EU/1/15/1045/007 14x1 tablets EU/1/15/1045/008 28x1 tablets EU/1/15/1045/024 49x1 tablets EU/1/15/1045/009 56x1 tablets EU/1/15/1045/010 98x1 tablets
Icelandic: EU/1/15/1045/007 14x1 tafla EU/1/15/1045/008 28x1 tafla EU/1/15/1045/024 49x1 tafla EU/1/15/1045/009 56x1 tafla EU/1/15/1045/010 98x1 tafla
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2015
Icelandic: 16 nóvember 2015
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 30 mg tablets aripiprazole
Icelandic: Aripiprazole Accord 30 mg töflur aripíprazól
English: Seizure
Icelandic: Slæving
English: Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema,
Icelandic: bráðaofnæmi, ofnæmisbjúgur þar með talin þrútin tunga,
English: Leukopenia Neutropenia Thrombocytopenia
Icelandic: Ofseyting munnvatns Uppköst
English: For darbepoetin alfa:
Icelandic: Fyrir darbepóetín alfa:
English: Adopted at the 3-6 July 2017 PRAC
Icelandic: Samþykkt á fundi PRAC 3.-6. júlí 2017
English: For all epoetins
Icelandic: Fyrir öll epóetín
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 July 2017
Icelandic: 30 Churchill Place ● Canary Wharf ● London E14 5EU ●
English: The doctor may advise that you have your blood pressure and urine regularly checked.
Icelandic: Læknirinn gæti ráðlagt þér að láta mæla blóðþrýstinginn og rannsaka þvag reglulega.
English: Talk to your doctor before taking <product name>, if you have:
Icelandic: Leitið ráða hjá lækninum áður en <heiti lyfs> er notað, ef þú er með:
English: Side effects where the frequency is not known
Icelandic: Aukaverkanir þar sem tíðini er ekki þekkt
English: Adverse reaction (MedDRA term)
Icelandic: Aukaverkun (samkvæmt MedDRA)
English: Stop using <product name> if you develop these symptoms and contact your doctor or seek medical attention immediately.
Icelandic: Hættu að nota <heiti lyfs> ef þú færð þessi einkenni og hafðu strax samband við lækninn eða leitaðu eftir læknisaðstoð.
English: Uncommon side effects (may affect up to 1 in 100 people)
Icelandic: Sjaldgæfar: geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum
English: <Product name> tonicity: XXX
Icelandic: Þrýstni lausnar <heiti lyfs>: XXX
English: The highest risk has been reported in patients with diffuse systemic sclerosis.
Icelandic: Mesta hættan sem tilkynnt hefur verið um er hjá sjúklingum með útbreitt herslismein (diffuse systemic sclerosis).
English: The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%)
Icelandic: Minnsta hættan sem tilkynnt hefur verið um er hjá sjúklingum með lítið útbreitt herslismein (limited systemic sclerosis) (2%) og við upphaf á útbreiðslu heslismeins hjá börnum/unglingum (1%).
English: If you develop a serious rash or another of these skin symptoms, stop taking <product name> and contact your doctor or seek medical attention immediately.
Icelandic: Ef þú færð alvarleg útbrot eða eitthvert annað af þessum einkennum á húð skaltu hætta að nota <heiti lyfs> og hafa strax samband við lækninn eða leita eftir læknisaðstoð.
English: • Vasopressin analogues include: Desmopressin, oxytocin, vasopressin, terlipressin
Icelandic: Desmopressin, oxytocin, vasopressin, terlipressin
English: Fulvestrant - Anaphylactic reaction (EPITT no 18832)
Icelandic: 4. Fulvestrant - Bráðaofnæmisviðbrögð (EPITT nr. 18832)
English: • Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions
Icelandic: ofnæmisviðbrögð, þar með talin bólga í andliti, vörum, tungu og/eða hálsi sem geta verið merki um bráðaofnæmisviðbrögð
English: Blood pressure and renal function (s-creatinine) should therefore be routinely checked.
Icelandic: Því skal fylgjast reglulega með blóðþrýstingi og nýrnastarfsemi (s-kreatíníni).
English: Monitoring of serum sodium is particularly important for physiologically hypotonic fluids.
Icelandic: Eftirlit með natríum í sermi er sérstaklega mikilvægt fyrir lífeðlisfræðilega vanþrýstna vökva.
English: Frequency ‘unknown': Scleroderma renal crisis* *see section c)
Icelandic: Bráð nýrnabilun vegna herslismeins (scleroderma)* *sjá kafla c)
English: SmPC for IV fluids without glucose
Icelandic: SmPC fyrir innrennslislausnir án glúkósa
English: When renal crisis is suspected, blood pressure should be carefully controlled.
Icelandic: Þegar grunur er um bráða nýrnabilun skal hafa vandlega stjórn á blóðþrýstingi.