FrancophonIA/ELRC3.0 huggingface dataset:
English: Cariprazine 1.5 mg/day 97.1 ± 9.13 -21.27 (1.77) -7.97 (-12.94, -3.01) 0.0017 Cariprazine 3 mg/day 97.2 ± 8.66 -21.45 (1.74) -8.16 (-13.09, -3.22) 0.0013 Cariprazine 4.5 mg/day 96.7 ± 9.01 -23.77 (1.74) -10.48 (-15.41, -5.55) < 0.0001 Risperidone 4 mg/day 98.1 ± 9.50 -29.27 (1.74) -15.98 (-20.91, -11.04) < 0.0001* RGH-MD-04 (n=604)
Icelandic: Cariprazín 4,5 mg/dag 96,7 ± 9,01 -23,77 (1,74) -10,48 (-15,41; -5,55) <0,0001 Risperídón 4 mg/dag
English: Cariprazine caused bilateral cataract and secondary retinal changes (retinal detachment and cystic degeneration) in the dog.
Icelandic: Cariprazín olli dreri í báðum augum og afleiddum breytingum á sjónu (sjónulosi og blöðrumyndandi hrörnun) hjá hundum.
English: Cariprazine is well absorbed after oral administration.
Icelandic: Cariprazín frásogast vel eftir inntöku.
English: Reagila 3 mg hard capsules
Icelandic: Reagila 3 mg hörð hylki
English: Cariprazine has not been evaluated in patients with severe (CrCl < 30 mL/min) renal impairment (see section 4.2).
Icelandic: Cariprazín hefur ekki verið metið hjá sjúklingum með alvarlega (CrCl <30 ml/mín.)
English: In clinical trials, glucose-related adverse reactions have been reported with cariprazine (see section 5.1).
Icelandic: Greint hefur verið frá aukaverkunum tengdum blóðsykri í klínískum rannsóknum með cariprazíni (sjá kafla 5.1).
English: In another multinational placebo controlled study using fixed doses of 3.0 mg, and 6.0 mg cariprazine and 10 mg aripiprazole for assay sensitivity, both cariprazine doses and the active-control showed statistically significant improvement in both primary as well as secondary endpoint compared to placebo.
Icelandic: Í annarri fjölþjóðlegri samanburðarrannsókn með lyfleysu með föstum 3,0 mg og 6,0 mg skömmtum af cariprazíni og 10 mg af aripíprazóli fyrir næmi greiningarinnar, sýndu bæði skammtar cariprazíns og virka samanburðarlyfsins tölfræðilega marktæka framför bæði hvað varðar aðal- og aukaendapunkt, samanborið við lyfleysu.
English: The clinical consequences of this effect is not fully understood, however the use of P-gp substrates with narrow therapeutic index such as dabigatran and digoxin could require extra monitoring and dose adjustment.
Icelandic: P-gp hvarfefnum með þröngt skammtabil, eins og dabigatrani og digoxíni.
English: The capsules are filled with white to yellowish white powder mixture.
Icelandic: Hylkin eru fyllt með hvítu eða fölgulu dufti.
English: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Icelandic: Hvert hart hylki inniheldur cariprazínhýdróklóríð sem jafngildir 1,5 mg af cariprazíni.
English: No effects on male fertility were noted at exposures up to 4.8 times the clinical exposure at the MRHD.
Icelandic: Engin áhrif komu fram á frjósemi karldýra við útsetningu sem var allt að 4,8-föld klínísk útsetning við ráðlagðan hámarksskammt fyrir menn.
English: Weight increased Decreased appetite Increased appetite Dyslipidaemia
Icelandic: Minnkuð matarlyst Aukin matarlyst Blóðfituröskun
English: NAME OF THE MEDICINAL PRODUCT Reagila 1.5 mg hard capsules cariprazine
Icelandic: HEITI LYFS Reagila 1,5 mg hörð hylki cariprazín
English: 2Akathisia: Akathisia, Psychomotor hyperactivity, Restlessness 3Parkinsonism: Akinesia, Bradykinesia, Bradyphrenia, Cogwheel rigidity, Extrapyramidal disorder, Gait disturbance, Hypokinesia, Joint stiffness, Tremor, Masked facies, Muscle rigidity, Musculoskeletal stiffness, Nuchal rigidity, Parkinsonism
Icelandic: Hreyfitregða, seinhreyfni, hæg hugsun, tannhjólastirðnun (cogwheel rigidity), utanstrýtukvilli, göngulagstruflanir, vanhreyfni, stirðleiki í liðum, skjálfti, grímusvipur, vöðvastífleiki, stífleiki í stoðkerfi, hnakkastífleiki, heilkenni parkinsons
English: Baseline Mean ± SD
Icelandic: Meðaltal ± staðalfrávik (SD)
English: QT- prolongation
Icelandic: QT-lenging
English: Development of cataracts was observed in cariprazine non-clinical studies (see section 5.3).
Icelandic: Myndun drers kom fram í forklínískum rannsóknum með cariprazíni (sjá kafla 5.3).
English: Each hard capsule contains 0.0003 mg Allura red AC (E 129).
Icelandic: Hvert hart hylki inniheldur 0,0003 mg af allúrarauðu AC (E 129).
English: An additional metabolite, desdichlorophenyl piperazine cariprazine (DDCPPCAR) acid, is produced by dealkylation and subsequent oxidation of cariprazine.
Icelandic: Annað umbrotsefni, desdíklórófenýl-píperasín-cariprazínsýra (DDCPPCAR), myndast með alkýlsviptingu og síðan oxun á cariprazíni.
English: - anxiety - sleepiness, difficulty in sleeping, abnormal dreams, nightmare, sleepwalking - dizziness - involuntary twisting movements and strange postures - excessive teeth grinding or jaw clenching, drooling, persistent blinking in response to tapping of the forehead (an abnormal reflex), movement problems, tongue movement disturbance (these are called extrapyramidal symptoms) - blurred vision - high blood pressure - fast, irregular heartbeat - decreased or increased appetite - nausea, vomiting, constipation - weight increased - tiredness - the following can be seen in laboratory tests:
Icelandic: (óeðlilegt viðbragð), hreyfitruflanir, truflun á tunguhreyfingu (þetta kallast utanstrýtueinkenni) - þokusýn - hár blóðþrýstingur - hraður, óreglulegur hjartsláttur - minnkuð eða aukin matarlyst - ógleði, uppköst, hægðatregða - þyngdaraukning - þreyta - eftirfarandi getur komið fram í rannsóknarstofuprófunum:
English: Visual acuity reduced
Icelandic: Aukinn augnþrýstingur Sjónstillingarerfiðleikar Minnkuð sjónskerpa
English: - If you have any further questions, ask your doctor or pharmacist.
Icelandic: Ef ekki er ljóst hvernig nota á lyfið skal leita upplýsinga hjá lækninum eða lyfjafræðingi.
English: The efficacy of cariprazine for maintaining antipsychotic effect was investigated in a randomizedwithdrawal, long-term clinical study.
Icelandic: Ending verkunar cariprazíns gegn geðrofi var rannsökuð í klínískri, langtímarannsókn þar sem meðferð var hætt samkvæmt slembiröðun (randomized-withdrawal).
English: Titanium dioxide (E 171) Propylene glycol Simeticone
Icelandic: Títantvíoxíð (E 171) Própýlenglýkól Símetikón
English: NAME OF THE MEDICINAL PRODUCT Reagila 6 mg hard capsules cariprazine
Icelandic: HEITI LYFS Reagila 6 mg hörð hylki cariprazín
English: NAME OF THE MEDICINAL PRODUCT Reagila 4.5 mg hard capsules cariprazine
Icelandic: HEITI LYFS Reagila 4,5 mg hörð hylki cariprazín
English: The lowest effective dose should be maintained according to the clinical judgement of the treating physician.
Icelandic: Viðhalda skal lægsta skammtinum sem veitir verkun í samræmi við klínískt mat meðferðarlæknisins.
English: - decreased or increased sexual desire, erectile problems - eye irritation, high pressure in the eye, poor vision - focusing problems seeing at a distance to or seeing close-to - low blood pressure - abnormal ECG reading, abnormal nerve impulses in the heart - slow, irregular heart rate - hiccups - heartburn - thirst - pain when passing urine - abnormally frequent and large urinations - itching, rash - diabetes - the following can be seen in laboratory tests:
Icelandic: - minnkuð eða aukin kynhvöt, risvandamál - augnerting, hár þrýstingur í auganu, slæm sjón - vandamál með sjónskerpu við að sjá í fjarlægð eða við að sjá nálægt - lágur blóðþrýstingur - óeðlilegar niðurstöður á hjartarafriti, óeðlileg taugaboð í hjartanu - hægur, óreglulegur hjartsláttur - hiksti - brjóstsviði - þorsti - verkir við þvaglát - óeðlilega tíð eða mikil þvaglát - kláði, útbrot - sykursýki - eftirfarandi getur komið fram í rannsóknarstofuprófunum: ° óeðlilegt magn natríums í blóði ° hækkaður glúkósi í blóði (blóðsykur), aukið galllitarefni (bilirúbín) í blóði ° blóðleysi (fækkun rauðra blóðkorna) ° fjölgun ákveðinnar tegundar hvítra blóðkorna ° minnkað magn skjaldkirtilsörvandi hormóns (TSH) í blóðinu
English: Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias.
Icelandic: Hefja skal tafarlaust eftirlit með hjarta og æðakerfi, þ.m.t. sívöktun hjartarafrits, með tilliti til hugsanlegra hjartsláttartruflana.
English: Cardiovascular disorders
Icelandic: Breytingar á hjartarafriti
English: INFORMATION IN BRAILLE reagila 1.5 mg
Icelandic: MEÐ BLINDRALETRI reagila 1,5 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/029-036
Icelandic: MARKAÐSLEYFISNÚMER EU/1/17/1209/029-036
English: Adverse drug reactions (ADRs) based upon pooled data from cariprazine schizophrenia studies are shown by system organ class and by preferred term.
Icelandic: Aukaverkanir sem byggðar eru á sameinuðum upplýsingum úr rannsóknum á cariprazíni og geðklofa eru taldar upp eftir líffæraflokkum og kjörheiti.
English: to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
Icelandic: Aukaverkanir þar sem tíðni er ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum)
English: NAME OF THE MEDICINAL PRODUCT Reagila 3 mg hard capsules cariprazine
Icelandic: HEITI LYFS Reagila 3 mg hörð hylki cariprazín
English: Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Icelandic: Hvert hart hylki inniheldur cariprazínhýdróklóríð sem jafngildir 6 mg af cariprazíni.
English: Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Icelandic: Hvert hart hylki inniheldur cariprazínhýdróklóríð sem jafngildir 3 mg af cariprazíni.
English: Cushing's syndrome - when the body produces an excess of cortisol (medicines containing ketoconazole) depression (herbal therapy containing St. John's wort (Hypericum perforatum) and medicines containing nefazodone) epilepsy and seizures (medicines containing carbamazepine, phenobarbital and phenytoin) heart disease (medicines containing diltiazem and verapamil) sleepiness (medicines containing modafinil) high blood pressure in the lungs (medicines containing bosentan).
Icelandic: HIV-sýkingar (lyf sem innihalda cobicistat, indínavír, nelfínavír, rítónavír, sakvínavír, efavírenz og etravírín) sveppasýkingar (lyf sem innihalda ítrakónazól, posakónazól, vórikónazól og flúkónazól) Cushings heilkenni - þegar líkaminn framleiðir of mikið kortisól (lyf sem innihalda ketókónazól) þunglyndi (jurtameðferð sem inniheldur jóhannesarjurt (Hypericum perforatum) og lyf sem innihalda nefazódón) flogaveiki og krampa (lyf sem innihalda karbamazepín, fenóbarbital og fenýtóín) hjartasjúkdóma (lyf sem innihalda diltíazem og verapamíl) syfju (lyf sem innihalda módafíníl) háan blóðþrýsting í lungum (lyf sem innihalda bósentan).
English: Risperidone LS mean
Icelandic: (LS mean)
English: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotics - Frequency unknown.
Icelandic: Tilkynnt hefur verið um bláæðasegarek, þ.m.t. lungnasegarek og segamyndun í djúpbláæðum, við notkun geðrofslyfja - tíðni óþekkt.
English: Seizures/ Convulsion Amnesia Aphasia
Icelandic: Lækkun á stýrihormóni skjaldkirtils
English: Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Icelandic: Hvert hart hylki inniheldur cariprazínhýdróklóríð sem jafngildir 4,5 mg af cariprazíni.
English: Cartons contain 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Icelandic: Öskjur sem innihalda 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 eða 98 hörð hylki Reagila 4,5 mg og Reagila 6 mg hörð hylki
English: Risk of cerebrovascular accidents (CVA)
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: The rate of discontinuation due to EPS related ADRs was low.
Icelandic: Meðferð var sjaldan hætt vegna aukaverkana sem tengdust utanstrýtueinkennum.
English: Renal impairment
Icelandic: Reagila inniheldur
English: dyskinesia
Icelandic: Frásog
English: Seizures and convulsions
Icelandic: Flog og krampar
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/021-028
Icelandic: MARKAÐSLEYFISNÚMER EU/1/17/1209/021-028
English: Venous thromboembolism (VTE)
Icelandic: VIRK(T) EFNI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/001-040
Icelandic: MARKAÐSLEYFISNÚMER EU/1/17/1209/001-040
English: Neutropenia
Icelandic: Þunglyndi
English: MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Icelandic: MARKAÐSLEYFISHAFI Gedeon Richter Plc.
English: In case of severe extrapyramidal symptoms, anticholinergic medicinal products should be administered.
Icelandic: Komi alvarleg utanstrýtueinkenni fram skal gefa andkólínvirk lyf.
English: Cartons contain 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Icelandic: Öskjur sem innihalda 21, 28, 30, 49, 56, 60, 84, 90 eða 98 hörð hylki Ekki er víst að allar pakkningastærðir séu markaðssettar.
English: Musculoskele tal and connective tissue disorders
Icelandic: Minnkuð kynhvöt Aukin kynhvöt Ristruflanir
English: Reagila 6 mg hard capsules ‘Size 3' (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on the capsule body with black ink.
Icelandic: Hart gelatínhylki í „stærð 3“ (u.þ.b. 15,9 mm að lengd) með fjólubláu ógegnsæju loki og hvítum ógegnsæjum botni með „GR 6“ áletrað á botn hylkisins með svörtu bleki.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Icelandic: NAFN MARKAÐSLEYFISHAFA Gedeon Richter Plc.
English: INFORMATION IN BRAILLE reagila 3 mg
Icelandic: Reagila 3 mg:
English: The effect of food on the exposure of the metabolites DCAR and DDCAR was also minimal.
Icelandic: DCAR og DDCAR voru einnig í lágmarki.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/011-020
Icelandic: MARKAÐSLEYFISNÚMER EU/1/17/1209/011-020
English: Reagila 1.5 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Icelandic: Reagila 1,5 mg hörð hylki: forhleypt (maís) sterkja, magnesíumsterat, títantvíoxíð (E 171), gelatín, svart blek (gljálakk, svart járnoxíð (E 172), própýlenglýkól, kalíumhýdroxíð).
English: Differences on the Clinical Global Impression Severity (p=0.005) and Improvement (p<0.001) scales,
Icelandic: Munur á mælikvörðunum Clinical Global Impression Severity (p=0,005) og Framför (p<0,001), sem og svörunarhlutfall á PANSS-FSNS (PANSS FSNS ≥ 30% framför í viku 26; p= 0,003), studdi niðurstöður hvað varðar aðal- og aukaverkunstbreyturnar.
English: Cases of venous thromboembolism have been reported with antipsychotic medicinal products.
Icelandic: Tilkynnt hefur verið um bláæðasegarek hjá sjúklingum sem fá meðferð með geðrofslyfjum.
English: Cariprazine 3 mg/day 96.1 ± 8.7 -20.2 (1.5) Cariprazine 6 mg/day 95.7 ± 9.4 -23.0 (1.5) Aripiprazole 10 mg/day 95.6 ± 9.0 -21.2 (1.4) RGH-MD-05 (n=439)
Icelandic: Aripíprazól 10 mg/dag 95,6 ± 9,0 -21,2 (1,4)
English: INFORMATION IN BRAILLE reagila 4.5 mg
Icelandic: MEÐ BLINDRALETRI reagila 4,5 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/001-010
Icelandic: MARKAÐSLEYFISNÚMER EU/1/17/1209/001-010
English: You can help by reporting any side effects you may get.
Icelandic: Allir geta hjálpað til við þetta með því að tilkynna aukaverkanir sem koma fram Aftast í kafla 4 eru upplýsingar um hvernig tilkynna á aukaverkanir.
English: Tachyarrhytmi a
Icelandic: B. FYLGISEÐILL
English: Vision blurred Eye irritation Intraocular pressure increased
Icelandic: Svefnhöfgi Tilfinningartruflun í húð Hreyfitruflun6 Síðkomin hreyfitruflun
English: INFORMATION IN BRAILLE reagila 6 mg
Icelandic: MEÐ BLINDRALETRI reagila 6 mg
English: Reagila 6 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, brilliant blue FCF (E 133), allura red AC (E 129), titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Icelandic: Reagila 6 mg hörð hylki: forhleypt (maís) sterkja, magnesíumsterat, skærblátt FCF (E 133), allúrarautt AC (E 129), títantvíoxíð (E 171), gelatín, svart blek (gljálakk, svart járnoxíð (E 172), própýlenglýkól, kalíumhýdroxíð).
English: Elimination of cariprazine and its major active metabolites is mainly through hepatic metabolism.
Icelandic: Brotthvarf cariprazíns og helstu virku umbrotsefna þess fer aðallega fram með umbrotum í lifur.
English: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink.
Icelandic: 14,3 mm að lengd) með grænu ógegnsæju loki og hvítum ógegnsæjum botni með „GR 3“ áletrað á botn hylkisins með svörtu bleki.
English: Recordati BVBA Tel: + 32 2 46101 36 (België)
Icelandic: + 32 2 46101 36 (België)
English: Reagila 3 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Icelandic: Reagila 3 mg hörð hylki: forhleypt (maís) sterkja, magnesíumsterat, allúrarautt AC (E 129), skærblátt FCF (E 133), títantvíoxíð (E 171), gult járnoxíð (E 172), gelatín, svart blek (gljálakk, svart járnoxíð (E 172), própýlenglýkól, kalíumhýdroxíð).
English: Hypersensitivi ty
Icelandic: Illkynja sefunarheilk enni
English: Tlf: + 46 8 545 80 230 (Sverige)
Icelandic: +46 8 545 80 230 (Sverige)
English: Tlf: +46 8 545 80 230 (Sverige)
Icelandic: + 46 8 545 80 230 (Sverige)
English: Reagila 4.5 mg hard capsules ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink.
Icelandic: 14,3 mm að lengd) með grænu ógegnsæju loki og grænum ógegnsæjum botni með „GR 4.5“ áletrað á botn hylkisins með hvítu bleki.
English: The plasma concentration of total cariprazine decreases by 50% in ~1 week and greater than 90% decline in total cariprazine concentration occurs in ~3 weeks.
Icelandic: 1 viku og meira en 90% lækkun á heildarþéttni cariprazíns kemur fram á u.þ.b. 3 vikum.
English: 4Dystonia: Blepharospasm, Dystonia, Muscle tightness, Oromandibular dystonia, Torticollis, Trismus 5Other extrapyramidal diseases and abnormal movement disorders: Balance disorder, Bruxism, Drooling, Dysarthria, Gait deviation, Glabellar reflex abnormal, Hyporeflexia, Movement disorder, Restless legs syndrome, Salivary hypersecretion, Tongue movement disturbance 6Dyskinesia: Choreoathetosis, Dyskinesia, Grimacing, Oculogyric crisis, Protrusion tongue
Icelandic: Jafnvægistruflanir, tannagnístran, slefa, tormæli, göngulagsfrávik, óeðlilegt ennisleitisviðbragð, vanviðbrögð, hreyfiröskun, fótaóeirð, aukin munnvatnsmyndun, truflanir á hreyfingu tungu
English: Adverse reactions are ranked by frequency, the most frequent first, using the following convention:
Icelandic: Innan tíðniflokka eru alvarlegustu aukaverkanirnar taldar upp fyrst.
English: Tardive dyskinesia
Icelandic: Verkun við skammtímanotkun
English: Absolute bioavailability of cariprazine is unknown.
Icelandic: Nýting cariprazíns er óþekkt.
English: Reagila 1.5 mg hard capsules ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink.
Icelandic: 14,3 mm að lengd) með hvítu ógegnsæju loki og hvítum ógegnsæjum botni með „GR 1.5“ áletrað á botn hylkisins með svörtu bleki.
English: Dose selection for an elderly patient should be more cautious.
Icelandic: Gæta skal aukinnar varúðar við val á skammti handa öldruðum sjúklingi.
English: Akathisia, restlessness
Icelandic: Hvíldaróþol, eirðarleysi
English: Weight change
Icelandic: Þyngdaraukning
English: Vascular disorders
Icelandic: Hraðsláttarglöp
English: Hepatic impairment
Icelandic: Ógleði Hægðatregða Uppköst
English: Even after treatment is stopped, contraception must be used for at least 10 weeks after your last dose of Reagila.
Icelandic: 10 vikur eftir síðasta skammtinn af Reagila.
English: Following multiple-dose administration, peak plasma concentrations for cariprazine and the major active metabolites generally occur at approximately 3-8 hours post dose.
Icelandic: Eftir gjöf endurtekinna skammta næst hámarksþéttni cariprazíns og helstu virku umbrotsefnanna í plasma yfirleitt u.þ.b.
English: ° increase in a type of white blood cells
Icelandic: Hækkaður gallrauði í blóði
English: What you need to know before you take Reagila
Icelandic: Áður en byrjað er að nota Reagila
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Reagila 1.5 mg hard capsules
Icelandic: Reagila 1,5 mg hörð hylki
English: Lens opacity/Cataract
Icelandic: Deutschland Recordati Pharma GMBH
English: Pregnancy
Icelandic: Slæving
English: Side effects with not known frequency (frequency cannot be estimated from the available data) - inflammation of the liver (pain in the upper right abdomen, yellowing of the eye and skin,
Icelandic: - bólga í lifur (verkur í efri hluta kviðar hægra megin, gulnun augna og húðar, þróttleysi, hiti)
English: Hypothyroidis m
Icelandic: 13. LOTUNÚMER
English: Neuroleptic malignant syndrome extrapyramidal diseases and abnormal movement disorders5
Icelandic: Önnur utanstrýtueinkenni og hreyfitruflanir5
English: 980 (10 x 98) tablets
Icelandic: 1.000 töflur (20 x 50 töflur)
English: EU Number
Icelandic: EU verkefnisnúmer Sérheiti Styrkur
English: Content Package size
Icelandic: Pakkningastærð
English: Bottle (glass type III)
Icelandic: Glas (gler af tegund III)
English: 4 litres 1 bottle Meat and offal: 14 days
Icelandic: Glas (HDPE) 4 lítrar
English: Please ask your doctor whether you can drive a car if you:
Icelandic: Spyrðu lækninn hvort þú ættir að aka ef þú:
English: • If you are under 18 or over 75 years of age.
Icelandic: - Ef þú ert yngri en 18 ára eða eldri en 75 ára.
English: Prandin with alcohol
Icelandic: Prandin með áfengi
English: Be aware that the desired effect is not achieved if you stop taking Prandin.
Icelandic: Hafðu í huga að tilætluð áhrif nást ekki ef þú hættir að taka Prandin.
English: Date of last renewal: 23 July 2008
Icelandic: 23. júlí 2008
English: If you miss a dose, take the next dose as usual - do not double the dose.
Icelandic: Ef þú missir úr einn skammt skaltu taka næsta skammt eins og venjulega - ekki taka tvöfaldan skammt.
English: • If you eat more than usual
Icelandic: - Ef þú borðar meira en venjulega.
English: Do not take more Prandin than your doctor has recommended.
Icelandic: Ekki á að taka stærri skammt af Prandin en læknirinn hefur ráðlagt.
English: Prandin should be taken with caution.
Icelandic: Taka skal Prandin með varúð.
English: What Prandin is and what it is used for
Icelandic: Upplýsingar um Prandin og við hverju það er notað
English: Do not use this medicine after the expiry date which is stated on the carton and the blister foil after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og þynnum á eftir EXP.
English: - The active substance is repaglinide.
Icelandic: - Virka innihaldsefnið er repaglíníð.
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known
Icelandic: sjaldgæfar (≥ 1/1.000 til 1/100); mjög sjaldgæfar (≥ 1/10.000 til < 1/1.000); koma örsjaldan fyrir
English: Polacrilin potassium Povidone (polyvidone) Glycerol 85%
Icelandic: Kalíumpólakrilín Póvídón (pólývídón) Glýseról 85%
English: • If you have a severe liver disease.
Icelandic: - Ef þú ert með alvarlegan lifrarsjúkdóm.
English: Iron oxide, red (E172)
Icelandic: Járnoxíð, rautt (E172)
English: • Clopidogrel (prevents blood clots)
Icelandic: Clopidogrel (kemur í veg fyrir blóðtappa).
English: Iron oxide, yellow (E172)
Icelandic: Járnoxíð, gult (E172)
English: If you forget to take Prandin
Icelandic: Ef gleymist að taka Prandin
English: • Diabetes mellitus type 1, C-peptide negative.
Icelandic: Sykursýki tegund 1, C-peptíð neikvæð.
English: • If you are about to have major surgery or you have recently suffered a severe illness or infection.
Icelandic: - Ef fyrirhugað er að gera á þér stóra skurðaðgerð eða ef þú hefur nýlega gengið í gegnum alvarleg veikindi eða sýkingu.
English: Each pack contains 30, 90, 120 or 270 tablets.
Icelandic: Í hverri pakkningu eru 30, 90, 120 eða 270 töflur.