FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment-emergent reactions during concomitant and monotherapy treatment phases in patients with newly diagnosed glioblastoma multiforme
Icelandic: Tafla 4. Aukaverkanir sem komu fram við meðferð meðan á samhliða- og einlyfjameðferð stóð hjá sjúklingum með nýgreint margfrumna taugakímsæxli
English: Temozolomide Accord 20 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Icelandic: Temozolomide Accord 20 mg hörð hylki: gelatín, títantvíoxið (E 171), gult járnoxíð (E 172), vatn.
English: a severe allergic reaction (rash which might be itchy, wheezing or other breathing difficulty), - uncontrolled bleeding, - Seizures (convulsions), - fever, - chills, - severe headache that does not go away.
Icelandic: óstöðvandi blæðingu, - flog (rykkjakrampa), - hita, - kuldahroll, - svæsinn höfuðverk sem hverfur ekki.
English: - thrombocyte count ≥ 100 x 109/l
Icelandic: • blóðflagnafjöldi ≥ 100 x 109/l
English: Each hard capsule contains 180 mg of temozolomide.
Icelandic: Hvert hart hylki inniheldur 180 mg af temózólómíði.
English: • thirst
Icelandic: • þreyta
English: Constipation, nausea, vomiting Constipation, nausea, vomiting
Icelandic: lungnabólga, skútabólga, berkjubólga, nefstífla, kvef eða inflúensa
English: Very rare:
Icelandic: Innkirtlar Sjaldgæfar:
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral
Icelandic: Síflog (status epilepticus), utanstrýturöskun, helftarslekja (hemiparesis), ósamræming vöðvahreyfinga, vitsmunaskerðing, málglöp (dysphasia), óeðlilegt göngulag, snertiskynsaukning, snertiskynsminnkun, taugaröskun (ótilgreind), úttaugakvilli
English: Abnormal blood values, headache, feeling or being sick, constipation, loss of appetite, tiredness
Icelandic: Óeðlileg blóðgildi, höfuðverkur, uppköst, ógleði, hægðatregða, lystarleysi, þreyta.
English: See section 4.
Icelandic: 3. stig skv.
English: The hard capsules are green/white hard gelatin capsules imprinted ‘TMZ' on cap & ‘5' on body.
Icelandic: Hörðu hylkin eru græn/hvít hörð gelatín hylki með áletruninni „TMZ“ á loki og „5“ á kjarna.
English: • bloated stomach, difficulty controlling your bowel movements, haemorrhoids (piles)
Icelandic: • þaninn kviður, erfiðleikar við að stjórna hægðum, gyllinæð
English: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine (E132)
Icelandic: Skel hylkja gelatín vatn títantvíoxið (E 171) gult járnoxíð (E172) indígókarmín (E132)
English: The hardcapsules are yellow/ white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘20' on body.
Icelandic: Hörðu hylkin eru gul/hvít hörð gelatín hylki með áletruninni „TMZ“ á loki og „20“ á kjarna.
English: Temozolomide Accord 100 mg hard capsules temozolomide
Icelandic: Temozolomide Accord 100mg hörð hylki Temózólómíð
English: Each hard capsule contains 100 mg of temozolomide.
Icelandic: Hvert hart hylki inniheldur 100 mg af temózólómíði.
English: Uncommon side-effects (may affect up to 1 in 100 people):
Icelandic: Sjaldgæfar aukaverkanir (geta komið fyrir hjá allt að 1 af hverjum 100):
English: • skin irritation or redness, dry skin, itching
Icelandic: erting eða roði í húð, þurr húð, kláði
English: Headache
Icelandic: hárlos
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/10/615/001
English: Laboratory parameters
Icelandic: LYFJAFRÆÐILEGAR
English: Convulsions were reported very commonly in the newlydiagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma.
Icelandic: Krampar voru mjög algeng aukaverkun hjá sjúklingum með nýgreint margfrumna taugakímsæxli, sem fengu einlyfjameðferð og útbrot voru mjög algeng hjá sjúklingum með nýgreint margfrumna taugakímsæxli sem fengu
English: Temozolomide Accord 180 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Icelandic: Temozolomide Accord 180 mg hörð hylki: gelatín, títantvíoxið (E 171), gult járnoxíð (E 172), rautt járnoxíð (E 172), vatn.
English: Dose during Cycles 2-6 in absence of toxicity Table 3.
Icelandic: Skammtur í 2.-6. meðferðarlotu án eituráhrifa Tafla 3. TMZ skammtaminnkun eða -stöðvun meðan á einlyfjameðferð stendur
English: The hard capsules are transparent blue/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘140' on body.
Icelandic: Hörðu hylkin eru gagnsæ blá/hvít hörð gelatín hylki með áletruninni „TMZ“ á loki og „140“ á kjarna.
English: Temozolomide Accord 100 mg hard capsules: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Icelandic: Temozolomide Accord 100 mg hörð hylki: gelatín, títantvíoxið (E 171), rautt járnoxíð (E 172), vatn.
English: Uncommon (may affect up to 1 in 100 people):
Icelandic: Sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 100):
English: Skin and subcutaneous tissue disorders Very rare:
Icelandic: Sýkingar af völdum sýkla og sníkjudýra Mjög sjaldgæfar:
English: Meningoencephalitis herpetic
Icelandic: CTC 4. stigb skv.CTC
English: Paediatric population
Icelandic: Heildarfjöldi daufkyrninga
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/033
Icelandic: MARKAÐSLEYFISNÚMER EU/1/10/615/033
English: Temozolomide Accord 100 mg hard capsules have a white body, a pink cap, and are imprinted ‘TMZ' on cap and ‘100' on body with black ink.
Icelandic: Temozolomide Accord 100 mg hörð hylki eru úr hvítum kjarna með bleiku loki, áletruð „TMZ“ á lok og „100“ á kjarna með svartri áletrun.
English: Temozolomide Accord 140 mg hard capsules temozolomide
Icelandic: Temozolomide Accord 140mg hörð hylki Temózólómíð
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 5 mg temozolomide.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 5 mg af temózólómíði.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/029
Icelandic: MARKAÐSLEYFISNÚMER EU/1/10/615/029
English: In post marketing cases, meningoencephalitis herpetic (including fatal cases) has been observed in patients receiving TMZ in combination with radiotherapy, including cases of concomitant steroids administration.
Icelandic: Eftir markaðssetningu hafa komið fram tilvik heilahimnu- og heilabólgu af völdum herpesveiru (þ.m.t. banvæn tilvik) hjá sjúklingum sem fengu TMZ ásamt geislameðferð, þ.m.t. tilvik með samhliðagjöf stera.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 140 mg hard capsules.
Icelandic: Temozolomide Accord 140 mg hörð hylki:
English: Titanium dioxide (E171)
Icelandic: Skel hylkja: gelatín vatn títantvíoxíð (E171)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 20 mg temozolomide.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 20mg af temózólómíði.
English: Temozolomide Accord 180 mg hard capsules have a white body, a maroon cap, and are imprinted ‘TMZ' on cap and ‘180' on body with black ink.
Icelandic: Temozolomide Accord 180 mg hörð hylki eru úr hvítum kjarna með rauðbrúnu loki, áletruð „TMZ“ á lok og „180“ á kjarna með svartri áletrun.
English: Cushingoid
Icelandic: Algengar
English: Water
Icelandic: Glas
English: Printing ink Shellac
Icelandic: TMZ hléa
English: exanthema
Icelandic: INNIHALDSLÝSING
English: Titanium dioxide (E171) Indigo carmine (E132).
Icelandic: Skel hylkja: gelatín vatn títantvíoxíð (E171) indigókarmín (132)
English: The hard capsules are pink/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘100' on body.
Icelandic: Hörðu hylkin eru bleik/hvít hörð gelatín hylki með áletruninni „TMZ“ á loki og „100“ á kjarna.
English: SACHET LABEL
Icelandic: KLÍNÍSKAR UPPLÝSINGAR
English: • muscle weakness, painful joints, muscle aches and pains
Icelandic: vöðvamáttleysi, verkir í liðum, vöðvaeymsli og vöðvaverkir
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SACHET CARTON
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM ASKJA FYRIR SKAMMTAPOKA
English: diabetes insipidus
Icelandic: óeðlileg lifrarpróf
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 250 mg hard capsules.
Icelandic: Temozolomide Accord 250 mg hörð hylki:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/021
Icelandic: MARKAÐSLEYFISNÚMER EU/1/10/615/021
English: - The other ingredients are: capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Icelandic: Vatnsfrí laktósa, vatnsfrítt sílica kolloid, natríum-glýkolatsterkja af gerð A, vínsýra, sterínsýra.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/025
Icelandic: MARKAÐSLEYFISNÚMER EU/1/10/615/025
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 140 mg hard capsules temozolomide
Icelandic: HEITI LYFS Temozolomide Accord 140 mg hörð hylki
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/013
Icelandic: MARKAÐSLEYFISNÚMER EU/1/10/615/013
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/031
Icelandic: MARKAÐSLEYFISNÚMER EU/1/10/615/031
English: Diarrhoea, abdominal pain, dyspepsia
Icelandic: Lungnablóðrek, bjúgur, útlimabjúgur
English: Printing ink
Icelandic: Illkynja mein
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Icelandic: Skel hylkja: gelatín vatn títantvíoxíð (E171) gult járnoxíð (172) rautt járnoxíð (172)
English: Mechanism of action
Icelandic: Einlyfjafasi
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg temozolomide.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 250mg af temózólómíði.
English: Impotence
Icelandic: Flóðmiga
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 5 mg hard capsules temozolomide STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 5 mg of temozolomide.
Icelandic: - Virka innihaldsefnið er temózólómíð Temozolomide Accord 5 mg hörð hylki:
English: Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct.
Icelandic: Frumuskemmandi áhrif, sem þróast á þennan hátt, virðast hafa í för með sér óeðlilegt viðhald á metýl aðfærslunni.
English: An updated RMP should be submitted:
Icelandic: TMZ meðferð á að stöðva ef:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 250 mg hard capsules temozolomide
Icelandic: HEITI LYFS Temozolomide Accord 250 mg hörð hylki
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 20 mg hard capsules.
Icelandic: Temozolomide Accord 20 mg hörð hylki:
English: • sexual impotence, vaginal bleeding, absent or heavy menstrual periods, vaginal irritation, breast pain,
Icelandic: • getuleysi, blæðing frá leggöngum, tíðateppa eða miklar blæðingar, erting í leggöngum, verkur í brjóstum
English: Dysuria
Icelandic: ASKJA
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 5 mg hard capsules.
Icelandic: HEITI LYFS Temozolomide Accord 5 mg hörð hylki
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 20 mg hard capsules temozolomide
Icelandic: HEITI LYFS Temozolomide Accord 20 mg hörð hylki
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Icelandic: Helftarslekja (hemiparesis), málstol (aphasia), skert jafnvægi, svefnhöfgi, ringlun, sundl, minnisskerðing, skert einbeiting, málglöp (dysphasia), taugaröskun (ótilgreind), taugakvilli, úttaugakvilli, náladofi, taltruflanir, skjálfti
English: Titanium dioxide (E171) Iron oxide red (E172)
Icelandic: Skel hylkja: gelatín vatn títantvíoxíð (E171) rautt járnoxíð (172)
English: • sores or ulcers in the mouth, diarrhoea, stomach pain, heartburn, difficulty swallowing, dry mouth
Icelandic: eymsli eða sár í munni, niðurgangur, magaverkur, brjóstsviði, kyngingarörðugleikar, munnþurrkur
English: • infections, wound infection, sore throat, fungal infections in the mouth, cold sores
Icelandic: • sýkingar, sárasýkingar, hálsbólga, sveppasýkingar í munni, frunsur
English: If you accidentally get some in your eyes or nose, flush the area with water.
Icelandic: Skolið með vatni, ef duftið kemst í snertingu við augu eða nef fyrir slysni.
English: Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Icelandic: Tilvik um hækkun á bilirúbíni, gallrennslishindrun, lifrarbólgu og lifrarskemmdir þ.m.t. lifrarbilun sem leitt hefur til dauða er sjaldgæft að tilkynnt hafi verið um.
English: ANNEX II
Icelandic: 2. stig CTC
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste
Icelandic: Ofnæmi, hiti, áverki af geislameðferð, andlitsbjúgur, verkur, truflað bragðskyn
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Icelandic: Skel hylkja: gelatín vatn títantvíoxíð (E171) gult járnoxíð (172)
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 180 mg hard capsules.
Icelandic: HEITI LYFS Temozolomide Accord 180 mg hörð hylki
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 100 mg hard capsules.
Icelandic: Temozolomide Accord 100 mg hörð hylki:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 100 mg hard capsules temozolomide
Icelandic: HEITI LYFS Temozolomide Accord 100 mg hörð hylki
English: Micturition frequency, urinary incontinence
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: Hemianopia, visual acuity
Icelandic: Eitilfrumnafæð, depilblæðingar
English: Rash, pruritus, alopecia
Icelandic: Svefnleysi, sundl, dofi
English: Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Icelandic: *Einn sjúklingur sem var valinn af handahófi í geislameðferðarhóp fékk TMZ + geislameðferð.
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥1.5 x 109/l and platelet count ≥ 100 x 109/l.
Icelandic: ANC  1,5 x 109/l og fjöldi blóðflagna  100 x 109/l.
English: Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Icelandic: Vart varð við mergbælingu (daufkyrningafæð og blóðflagnafæð) sem er þekkt, skammtatakmarkandi eiturverkun flestra frumueyðandi lyfja, að meðtöldu TMZ.
English: reduced, vision disorder, visual field defect, eye pain eyes dry
Icelandic: Skert sjónskerpa, augnverkur, augnþurrkur
English: • mood swings, depression, hallucination and memory loss
Icelandic: skapsveiflur, þunglyndi, ofskynjanir og skert minni
English: • loss of hearing, ringing noise in the ear
Icelandic: • skert heyrn, eyrnasuð
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Icelandic: Lyfjaform Íkomuleið Innri umbúðir
English: and 5.2).
Icelandic: og 5.2).
English: They may be taken with or without food.
Icelandic: Taka má þær með eða án matar.
English: After 2−4 weeks, your doctor may increase the dose to get the right effect.
Icelandic: Eftir 2−4 vikur kann læknirinn að stækka skammtinn til að fá rétt áhrif.
English: - if you have low weight (60 kg or less).
Icelandic: - ef líkamsþyngd þín er lítil (60 kg eða þar undir).
English: 24041 Brembate (BG) Italy or
Icelandic: 24041 Brembate (BG) Ítalía eða
English: No similar changes have been identified in humans.
Icelandic: Engar svipaðar breytingar hafa greinst hjá mönnum.
English: If you forget to take a dose, take it as soon as you remember unless it is nearly time (less than 6 hours) to take your next dose.
Icelandic: Ef þú gleymir að taka skammt, skaltu taka hann um leið og þú manst eftir honum, nema næstum sé kominn tími (innan við 6 klst.) til að taka næsta skammt.
English: The following has also been reported:
Icelandic: Einnig hefur verið greint frá eftirfarandi:
English: Additionally, 45% of the study population also received long-acting nitrates.
Icelandic: Þar að auki fengu 45% af rannsóknarþýðinu einnig langvirk nítröt.
English: - if you are elderly.
Icelandic: - ef þú ert á efri árum.
English: You must talk to a doctor if you do not feel better or if you feel worse.
Icelandic: Þú verður að ræða við lækninn ef líðan þín batnar ekki eða hún versnar.
English: Ranexa with food and drink
Icelandic: Notkun Ranexa með mat eða drykk
English: Germany or
Icelandic: Þýskaland eða
English: You may need to read it again.
Icelandic: Nauðsynlegt getur verið að lesa hvort um sig síðar.
English: Always swallow the tablets whole with water.
Icelandic: Kyngdu töflunum ávallt heilum með vatni.
English: Do not chew.
Icelandic: Má ekki tyggja.
English: If you experience these symptoms, do not drive or operate machinery until they have resolved completely.
Icelandic: Ef vart verður slíkra einkenna skal hvorki aka né stjórna vélum þar til þau hafa hjaðnað fullkomlega.
English: - if you have heart failure.
Icelandic: - ef þú ert með hjartabilun.
English: Use in children and adolescents Children and adolescents under 18 years old should not take Ranexa.
Icelandic: Notkun handa börnum og unglingum Börn og unglingar yngri en 18 ára mega ekki taka Ranexa.
English: If you cannot contact your doctor, go to the nearest accident and emergency department.
Icelandic: Ef þú getur ekki náð sambandi við lækninn skaltu fara á næstu slysa- eða bráðadeild.
English: Ranexa can be taken with or without food.
Icelandic: Ranexa má taka með eða án matar.
English: Менарини България” ЕООД тел.
Icelandic: Менарини България” ЕООД
English: Depending on the tablet strength, the tablet coatings also contain:
Icelandic: Eftir styrk töflunnar inniheldur töfluhúðin einnig:
English: Feeling of coldness in hands and legs
Icelandic: Kuldatilfinning í höndum og fótleggjum
English: Your doctor may decide to give you a lower dose or take other precautions if any of these apply to you.
Icelandic: Læknirinn gæti ákveðið að gefa þér lægri skammt eða gera aðrar varúðarráðstafanir, ef eitthvað af framantöldu á við um þig.
English: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany or
Icelandic: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Þýskaland eða
English: Fourteen primary pathways have been identified of which O-demethylation and N-dealkylation are the most important.
Icelandic: Fjórtán meginefnaferli hafa greinst og af þeim er O-afmetýlering og N-afalkýlering mikilvægust.
English: Your doctor may lower your dose or, if this is not sufficient, stop treatment with Ranexa.
Icelandic: Læknirinn kann að lækka skammtinn eða, ef það nægir ekki, hætta meðferð með Ranexa.
English: Dosedependent side effects are likely to occur.
Icelandic: Líklegt er að skammtaháðar aukaverkanir komi fram.
English: The safety and efficacy of Ranexa in children below the age of 18 years have not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun Ranexa hjá börnum yngri en 18 ára.
English: Do not crush, suck, or chew the tablets or break them in half, as this might affect the way the medicine is released from the tablets into your body.
Icelandic: Ekki má mylja, sjúga eða tyggja töflurnar og ekki má brjóta þær í tvennt, þar sem það gæti haft áhrif á losunarmáta lyfsins úr töflunum inn í líkamann.
English: Ask your doctor for advice about driving or using machines.
Icelandic: Leitið ráða hjá lækninum um akstur eða notkun véla.
English: These medicines may cause muscle pain and muscle injury.
Icelandic: Þessi lyf geta valdið vöðvaverkjum og vöðvaskemmdum.
English: Your doctor may decide to change the dose of this medicine while you are taking Ranexa.
Icelandic: Læknirinn getur ákveðið að breyta skammtinum af þessu lyfið á meðan þú tekur Ranexa.
English: There was no renal toxicity related to these findings.
Icelandic: Engar eiturverkanir á nýru tengdust þessum niðurstöðum.
English: QT prolongation was more pronounced in these patients.
Icelandic: Lenging á QT-bili var meira áberandi hjá þessum sjúklingum.
English: Date of last renewal: 06 March 2013
Icelandic: 06. mars 2013
English: If symptoms do not resolve after dose reduction, treatment should be discontinued.
Icelandic: Ef einkenni hjaðna ekki eftir að skammtur hefur verið minnkaður skal hætta meðferð.
English: Decreased or loss of consciousness
Icelandic: Minnkuð meðvitund eða meðvitundarleysi
English: Loss of appetite and/or weight loss
Icelandic: Lystarleysi og/eða þyngdartap
English: Your doctor may decide to give you a lower dose.
Icelandic: Læknirinn kann að ákveða að gefa lægri skammt.
English: If you forget to take Ranexa
Icelandic: Ef gleymist að taka Ranexa
English: Other side effects you may experience include the following:
Icelandic: Aðrar aukaverkanir sem fram gætu komið eru m.a. eftirfarandi:
English: Do not use this medicine after the expiry date which is stated on each blister strip of tablets and on the outside of the carton and bottle after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á hverjum þynnustrimli með töflum og utan á öskjunni og lyfjaglasinu á eftir EXP.
English: Ranexa is supplied in cartons containing 30, 60, or 100 tablets in blister strips or 60 tablets in plastic bottles.
Icelandic: Ranexa fæst í öskjum sem innihalda 30, 60 eða 100 töflur í þynnustrimlum eða 60 töflur í plastlyfjaglösum.
English: The active substance in Ranexa is ranolazine.
Icelandic: Virka innihaldsefnið í Ranexa er ranólazín.
English: Fine Foods N.T.M.
Icelandic: Fine Foods N.T.M. SpA
English: Blister pack: 5 years Bottle pack: 4 years
Icelandic: 5 ár Lyfjaglasi 4 ár
English: If a patient experiences treatment-related adverse events (e.g. dizziness, nausea, or vomiting), downtitration of Ranexa to 500 mg or 375 mg twice daily may be required.
Icelandic: Ef sjúklingur fær meðferðartengdar aukaverkanir (t.d. sundl, ógleði eða uppköst) kann að vera nauðsynlegt að títra Ranexa niður í 500 mg eða 375 mg tvisvar á dag.
English: Take along any tablets that are left, including the container and the carton, so that the hospital staff can easily tell what you have taken.
Icelandic: Taktu með þér töflurnar sem þú átt eftir, og sömuleiðis ílátið og öskjuna, þannig að starfsfólkið á sjúkrahúsinu geti auðveldlega áttað sig á hvaða töflur þú hefur tekið.
English: What Ranexa is and what it is used for 2.
Icelandic: Upplýsingar um Ranexa og við hverju það er notað 2.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Icelandic: Skilyrði um hvernig leggja skal fram samantektir um öryggi lyfsins koma fram í lista yfir viðmiðunardagsetningar Evrópusambandsins (EURD lista) sem gerð er krafa um í grein 107c(7) í tilskipun 2001/83 og öllum síðari uppfærslum sem birtar eru í evrópsku lyfjavefgáttinni.
English: Ranolazine is a substrate for P-gp.
Icelandic: Ranólazín er hvarfefni fyrir P-gp.
English: No studies on the effects of Ranexa on the ability to drive and use machines have been performed.
Icelandic: Engar rannsóknir hafa verið gerðar til að kanna áhrif Ranexa á hæfni til aksturs eða notkunar véla.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
Icelandic: Aukaverkanir eru flokkaðar eftir tíðni sem mjög algengar ( 1/10), algengar ( 1/100 til  1/10), sjaldgæfar ( 1/1.000 til < 1/100), mjög sjaldgæfar ( 1/10.000 til < 1/1.000) og koma örsjaldan fyrir (< 1/10.000).
English: Ranexa exposure increases more than in proportion to dose.
Icelandic: Útsetning fyrir Ranexa eykst meira en í hlutfalli við skammt.
English: If you accidentally take too many Ranexa tablets or take a higher dose than recommended by your doctor, it is important that you tell your doctor at once.
Icelandic: Ef tekinn er stærri skammtur af Ranexa en mælt er fyrir um Ef þú tekur fyrir slysni of margar Ranexa töflur, eða tekur hærri skammt en læknirinn mælir með, er mikilvægt að þú látir lækninn tafarlaust vita.