FrancophonIA/ELRC3.0 huggingface dataset:
English: • Tell your doctor if you are taking phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted.
Danish: • Fortæl det til lægen, hvis De tager phenytoin (medicin mod epilepsi), da dosis muligvis skal justeres.
English: A study in healthy subjects showed no effect of eslicarbazepine acetate 1,200 mg once daily on digoxin pharmacokinetics, suggesting that eslicarbazepine acetate has no effect on the transporter P-glycoprotein.
Danish: I et studie med raske forsøgspersoner havde eslicarbazepinacetat 1200 mg en gang dagligt ingen effekt på digoxins farmakokinetik, hvilket tyder på, at eslicarbazepinacetat ikke har nogen effekt på transportproteinet P-glykoprotein.
English: Animal studies have shown excretion of eslicarbazepine in breast milk.
Danish: Dyrestudier har vist, at eslicarbazepin udskilles i moderdyrets mælk.
English: During treatment with Exalief dose adjustment is recommended in patients with creatinine clearance <60 ml/min (see section 4.2).
Danish: Dosisjustering anbefales under behandling med Exalief hos patienter med kreatininclearance <60 ml/min (se pkt.
English: Alopecia, dry skin, hyperhidrosis, erythema, nail disorder, skin disorder
Danish: Alopeci, tør hud, hyperhidrose, erytem, neglelidelser, hudlidelser
English: Therefore, women of childbearing potential must use adequate contraception during treatment with Exalief, and up to the end of the current menstruation cycle after the treatment has been discontinued (see section 4.4 and 4.6).
Danish: Kvinder i den fertile alder skal derfor benytte tilstrækkelig kontraception under behandling med Exalief og frem til afslutningen på den aktuelle menstruationscyklus efter endt behandling (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 20, 30, 60 or 90 tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 20, 30, 60 eller 90 tabletter
English: Monitoring and prevention
Danish: Monitorering og profylakse
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS ALU/ALU blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS ALU/ALU-blisterkort
English: Eslicarbazepine has inhibiting properties with respect to CYP2C19.
Danish: Eslicarbazepin virker hæmmende på CYP2C19.
English: Studies in healthy subjects and patients showed that pharmacokinetics of eslicarbazepine acetate were not affected by gender.
Danish: Studier med raske forsøgspersoner og patienter viste, at eslicarbazepins farmakokinetik var uafhængig af køn.
English: If this happens to you, do not drive or use any tools or machines.
Danish: Lad være med at færdes i trafikken eller arbejde med værktøj eller maskiner, hvis De oplever nogle af disse bivirkninger.
English: Haemodialysis removes eslicarbazepine acetate metabolites from plasma.
Danish: Hæmodialyse fjerner eslicarbazepinacetats metabolitter fra plasma.
English: • Agitated
Danish: • Ophidselse
English: However, based on individual response, the dose may be increased.
Danish: Denne dosis kan dog øges afhængigt af den enkelte patients respons.
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99
Danish: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal Tlf.: +351 22 986 61 00
English: PHARMACEUTICAL FORM AND CONTENTS 7 tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7 tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 30 or 60 tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 30 eller 60 tabletter
English: • you have rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Danish: • Udslæt, besvær med at synke eller trække vejret, hævelser i læber, ansigt, hals eller tunge.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: • you have liver problems.
Danish: • hvis De har dårlig lever.
English: Drug toxicity, fall, joint and procedural complications injury, poisoning, skin
Danish: Lægemiddelstoksicitet, fald, ledskader, forgiftning, hudskader
English: In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4.
Danish: In vivo udviste eslicarbazepin en inducerende virkning på metabolismen af lægemidler, der hovedsageligt metaboliseres via CYP3A4.
English: No second or higher degree AV block was seen in eslicarbazepine acetate treated patients.
Danish: Der er ikke set 2. eller 3. grads AV-blok hos patienter i behandling med eslicarbazepinacetat.
English: Take special care when taking Exalief to avoid accidental injury (fall).
Danish: Vær ekstra forsigtig med at undgå uheld (fald) under behandlingen med Exalief.
English: A study in healthy subjects with eslicarbazepine acetate 1,200 mg once daily showed a minor average pharmacokinetic interaction (exposure of lamotrigine decreased 15%) between eslicarbazepine acetate and lamotrigine and consequently no dose adjustments are required.
Danish: Et studie med administration af eslicarbazepinacetat 1200 mg en gang dagligt til raske forsøgspersoner viste en mindre gennemsnitlig farmakokinetisk interaktion (eksponering for lamotrigin faldt med 15 %) mellem eslicarbazepinacetat og lamotrigin, og dosisjustering er derfor ikke nødvendig.
English: Insomnia, apathy, depression, nervousness, agitation, irritability, attention deficit/ hyperactivity disorder, confusional state, mood swings, crying, psychomotor retardation, stress, psychotic disorder
Danish: Insomni, apati, depression, nervøsitet, agitation, irritabilitet, nedsat opmærksomhed/hyperaktivitet, konfusion, stemningslabilitet, grådlabilitet, psykomotorisk retardering, stress, psykose
English: • Having irregular periods
Danish: • Uregelmæssig menstruation
English: • Tell your doctor if you are taking simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted.
Danish: • Fortæl det til lægen, hvis De tager simvastatin (medicin til at sænke kolesteroltallet), da dosis måske skal justeres.
English: What Exalief is and what it is used for Before you take Exalief How to take Exalief Possible side effects How to store Exalief Further information
Danish: Det skal De vide, før De begynder at tage Exalief Sådan skal De tage Exalief Bivirkninger
English: PHARMACEUTICAL FORM AND CONTENTS 90 tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 90 tabletter
English: Administration of eslicarbazepine acetate 1,200 mg once daily to female subjects using a combined oral contraceptive showed an average decrease of 37% and 42% in systemic exposure to levonorgestrel and ethinyloestradiol, respectively, most likely caused by an induction of CYP3A4.
Danish: Administration af eslicarbazepinacetat 1200 mg en gang dagligt til kvindelige forsøgspersoner, som brugte et oralt kontraceptivum af kombinationstypen, viste et gennemsnitligt fald på henholdsvis 37 % og 42 % i systemisk eksponering for levonorgestrel og ethinylestradiol, sandsynligvis pga. induktion af CYP3A4.
English: Dyspepsia, gastritis, abdominal pain, dry mouth, abdominal discomfort, abdominal distension, duodenitis, epigastric discomfort, gingival hyperplasia, gingivitis , irritable bowel syndrome, melaena, odynophagia, stomach discomfort, stomatitis, toothache
Danish: Dyspepsi, gastritis, abdominalsmerter, mundtørhed, abdominalgener, oppustethed, duodenitis, epigastrisk ubehag, gingival hyperplasi, gingivitis, colon irritabile, melæna, odynofagi, mavegener, stomatitis, tandpine
English: Vision disturbance, oscillopsia, binocular eye movement disorder, ocular hyperaemia, saccadic eye movement, eye pain
Danish: Synsforstyrrelser, oscillopsi, forstyrrelser i binokulært syn, okulær hyperæmi, saccadiske øjenbevægelser,
English: Pharmacotherapeutic group: Antiepileptics, Carboxamide derivatives, ATC code: N03AF04
Danish: ATC-kode: N03AF04
English: • Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth
Danish: • Halsbrand, urolig mave, mavesmerter, oppustethed og ubehag eller mundtørhed
English: Additional non-hormonal forms of contraception are recommended when using Exalief (see section 4.5 and 4.6).
Danish: Det anbefales at benytte ikke-hormonel kontraception under behandling med Exalief (se pkt.
English: Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is mainly eliminated by glucuronidation.
Danish: Eslicarbazepinacetat omdannes i udstrakt grad til eslicarbazepin, der hovedsageligt elimineres ved omdannelse til glukuronid.
English: EU/1/09/520/012 20 tablets - ALU/ALU blister EU/1/09/520/013 30 tablets - ALU/ALU blister EU/1/09/520/014 60 tablets - ALU/ALU blister EU/1/09/520/015 90 tablets - ALU/ALU blister EU/1/09/520/016 20 tablets - PVC/ALU blister EU/1/09/520/017 30 tablets - PVC/ALU blister EU/1/09/520/018 60 tablets - PVC/ALU blister EU/1/09/520/019 90 tablets - PVC/ALU blister
Danish: EU/1/09/520/012 20 tabletter - ALU/ALU-blisterkort EU/1/09/520/013 30 tabletter - ALU/ALU-blisterkort EU/1/09/520/014 60 tabletter - ALU/ALU-blisterkort EU/1/09/520/015 90 tabletter - ALU/ALU-blisterkort EU/1/09/520/016 20 tabletter - PVC/ALU-blisterkort EU/1/09/520/017 30 tabletter - PVC/ALU-blisterkort EU/1/09/520/018 60 tabletter - PVC/ALU-blisterkort EU/1/09/520/019 90 tabletter - PVC/ALU-blisterkort
English: A study in healthy subjects showed an average decrease of 50% in systemic exposure to simvastatin when co-administered with eslicarbazepine acetate 800 mg once daily, most likely caused by an induction of CYP3A4.
Danish: I et studie med raske forsøgspersoner sås en gennemsnitlig stigning på 50 % i den systemiske eksponering for simvastatin, når det blev anvendt sammen med eslicarbazepinacetat 800 mg en gang dagligt, hvilket sandsynligvis skyldtes induktion af CYP3A4.
English: Exalief 800 mg tablets are white and oblong.
Danish: Exalief 800 mg tabletter er hvide og aflange.
English: • Severe pain in the back and stomach
Danish: • Smerter i ryg eller nakke
English: Exalief 600 mg tablets are white and oblong.
Danish: Exalief 600 mg tabletter er hvide og aflange.
English: Common side effects are:
Danish: Almindelige bivirkninger:
English: The tablets have ‘ESL 800'engraved on one side and are scored on the other side, enabling the tablets to be divided into equal halves.
Danish: Tabletterne har 'ESL 800' præget på den ene side og delekærv på den anden side, så tabletten kan deles i to lige store dele.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21.04.2009
Danish: Dato for første tilladelse: 21/04/2009
English: Memory impairment, balance disorder, amnesia, hypersomnia, sedation, aphasia, dysaesthesia, dystonia, lethargy, parosmia, autonomic nervous system imbalance, cerebellar ataxia, cerebellar syndrome, grand mal convulsion, neuropathy peripheral, sleep phase rhythm disturbance, nystagmus, speech disorder, dysarthria, hypoaesthesia, ageusia, burning sensation
Danish: Svækket hukommelse, balanceforstyrrelser, amnesi, hypersomni, sedation, afasi, dysæstesi, dystoni, apati, lugtforstyrrelser, forstyrrelser i det autonome nervesystem, cerebral ataksi, cerebralt syndrom, tonisk-kloniske kramper, perifer neuropati, søvnrytmeforstyrrelser, nystagmus, taleforstyrrelser, dysartri, hypoæstesi, ageusi, brændende fornemmelse
English: Therefore it is recommended that you use other forms of safe and effective contraception, when taking Exalief up to the end of the current menstrual cycle after stopping treatment.
Danish: De bør derfor bruge anden sikker prævention under behandling med Exalief og frem til afslutningen på den aktuelle menstruationscyklus efter endt behandling.
English: Monoamino Oxidase Inhibitors (MAOIs)
Danish: Monoaminooxidasehæmmere (MAO-hæmmere)
English: • Tell your doctor if you are taking hormonal/oral contraceptives.
Danish: • Fortæl det til lægen, hvis De bruger hormonel prævention eller prævention, der tages gennem munden.
English: The tablets are packaged in blisters in cardboard boxes containing 20, 30, 60 or 90 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.
Danish: Tabletterne er pakket i blisterkort i æsker med 20, 30, 60 eller 90 tabletter samt i HDPE-flasker med børnesikret lukning i æsker med 90 tabletter.
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 800 mg once daily and carbamazepine 400 mg twice daily resulted in an average decrease of 32% in exposure to the active metabolite eslicarbazepine, most likely caused by an induction of glucuronidation.
Danish: I et studie med raske forsøgspersoner medførte samtidig administration af eslicarbazepinacetat 800 mg en gang dagligt og carbamazepin 400 mg to gange dagligt et gennemsnitligt fald på 32 % i eksponeringen for den aktive metabolit eslicarbazepin, hvilket formentligt skyldtes induktion af glukuronidering.
English: Caution should be exercised in the treatment of patients with renal impairment and the dose should be adjusted according to creatinine clearance (CLCR) as follows: - CLCR >60 ml/min: no dose adjustment required - CLCR 30-60 ml/min: initial dose of 400 mg every other day for 2 weeks followed by a once daily dose of
Danish: Der skal udvises forsigtighed ved behandling af patienter med nedsat nyrefunktion, og dosis skal justeres i henhold til kreatininclearance (CLCR) som følger: - CLCR >60 ml/min: Dosisjustering ikke nødvendig.
English: • Inflamed gums, mouth inflammation or toothache
Danish: • Betændelse i tandkødet eller munden eller tandpine
English: In the newborn child
Danish: Nyfødte
English: Interactions with other antiepileptic medicinal products Carbamazepine
Danish: Interaktion med andre antiepileptiske lægemidler
English: EU/1/09/520/007 30 tablets - ALU/ALU blister EU/1/09/520/008 60 tablets - ALU/ALU blister EU/1/09/520/009 30 tablets - PVC/ALU blister EU/1/09/520/010 60 tablets - PVC/ALU blister
Danish: EU/1/09/520/007 30 tabletter - ALU/ALU-blisterkort EU/1/09/520/008 60 tabletter - ALU/ALU-blisterkort EU/1/09/520/009 30 tabletter - PVC/ALU-blisterkort EU/1/09/520/010 60 tabletter - PVC/ALU-blisterkort
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and phenytoin resulted in an average decrease of 31-33% in exposure to the active metabolite, eslicarbazepine, most likely caused by an induction of glucuronidation, and an average increase of 31-35% in exposure to phenytoin, most likely caused by an inhibition of CYP2C19.
Danish: I et studie med raske forsøgspersoner medførte samtidig administration af eslicarbazepinacetat 1200 mg en gang dagligt og phenytoin et gennemsnitligt fald på 31-33 % i eksponeringen for den aktive metabolit eslicarbazepin, der sandsynligvis skyldtes induktion af glukuronidering, og en gennemsnitlig stigning på 31-35 % i eksponeringen for phenytoin, sandsynligvis pga. hæmning af CYP2C19.
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and topiramate showed no significant change in exposure to eslicarbazepine but an 18% decrease in exposure to topiramate, most likely caused by a reduced bioavailability of topiramate.
Danish: I et studie med samtidig administration af eslicarbazepinacetat 1200 mg en gang dagligt og topiramat til raske forsøgspersoner sås ingen signifikant ændring i eksponeringen for eslicarbazepin, mens der sås et 18 % fald i eksponeringen for topiramat, sandsynligvis pga. nedsat biotilgængelighed af topiramat.
English: Asthenia, malaise, chills, oedema peripheral, adverse drug reaction, peripheral coldness
Danish: Asteni, utilpashed, kuldegysninger, perifere ødemer, lægemiddelreaktion, kolde ekstremiteter
English: Exalief may make hormonal contraceptives such as the contraceptive pill less effective.
Danish: Exalief kan nedsætte sikkerheden af hormonelle præventionsmidler så som p-piller.
English: The tablets have ‘ESL 600'engraved on one side and are scored on the other side, enabling the tablets to be divided into equal halves.
Danish: Tabletterne har 'ESL 600' præget på den ene side og delekærv på den anden side, så tabletten kan deles i to lige store dele.
English: Exalief 800 mg tablets are packed in ALU/ALU or ALU/PVC blisters placed into cardboard boxes containing 20, 30, 60 or 90 tablets.
Danish: Exalief 800 mg tabletter fås i ALU/ALU- eller ALU/PVC-blisterkort i æsker med 20, 30, 60 eller 90 tabletter.
English: You must only take Exalief during pregnancy if your doctor tells you.
Danish: Hvis De er gravid, må De kun tage Exalief efter aftale med lægen.
English: EU/1/09/520/001 7 tablets - ALU/ALU blister EU/1/09/520/002 14 tablets - ALU/ALU blister EU/1/09/520/003 28 tablets - ALU/ALU blister EU/1/09/520/004 7 tablets - PVC/ALU blister EU/1/09/520/005 14 tablets - PVC/ALU blister EU/1/09/520/006 28 tablets - PVC/ALU blister
Danish: EU/1/09/520/001 7 tabletter - ALU/ALU-blisterkort EU/1/09/520/002 14 tabletter - ALU/ALU-blisterkort EU/1/09/520/003 28 tabletter - ALU/ALU-blisterkort EU/1/09/520/004 7 tabletter - PVC/ALU-blisterkort EU/1/09/520/005 14 tabletter - PVC/ALU-blisterkort EU/1/09/520/006 28 tabletter - PVC/ALU-blisterkort
English: Nocturia, urinary tract infection
Danish: Nykturi, urinvejsinfektion
English: However, Exalief is not recommended if you have severe liver problems.
Danish: De bør ikke tage Exalief, hvis De har en alvorlig leversygdom.
English: Specialist advice should be given to women who are likely to become pregnant or who are of child-bearing potential.
Danish: Fertile kvinder og kvinder med sandsynlighed for at blive gravide bør konsultere en specialist.
English: Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients.
Danish: Overfølsomhed over for eslicarbazepinacetat, andre carboxamidderivater (fx carbamazepin, oxcarbazepin) eller over for et eller flere af hjælpestofferne.
English: Peak plasma concentrations (Cmax) of eslicarbazepine are attained at 2-3 hours post-dose and steady state plasma concentrations are attained after 4 to 5 days of once daily dosing, consistent with an effective half-life in the order of 20-24 h. In studies in healthy subjects and epileptic adult patients, the apparent half-life of eslicarbazepine was 10-20 h and 13-20 h, respectively.
Danish: Maksimal plasmakoncentration (Cmax) af eslicarbazepin opnås 2 til 3 timer efter administration, og steady state-plasmakoncentration opnås efter 4 til 5 dages daglig indgift, svarende til en effektiv halveringstid på 20 til 24 timer.
English: • Blood in faeces
Danish: • Blod i afføringen
English: This leaflet was last approved in MMM/YYYY Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Denne indlægsseddel blev senest godkendt { MM/ÅÅÅÅ } De kan finde yderligere information om Exalief på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Diplopia*, vision blurred
Danish: Diplopi*, uskarpt syn
English: No dose adjustment is recommended in patients with mild to moderate liver impairment (see section 4.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion (se pkt.
English: INFORMATION IN BRAILLE Exalief 600 mg (outer pack only)
Danish: INFORMATION I BRAILLE-SKRIFT Exalief 600 mg (kun på den ydre emballage)
English: Eslicarbazepine acetate is extensively converted to eslicarbazepine.
Danish: Eslicarbazepinacetat omdannes i udstrakt grad til eslicarbazepin.
English: Exalief 400 mg tablets are packaged in ALU/ALU or ALU/PVC blisters placed into cardboard boxes containing 7, 14 or 28 tablets.
Danish: Exalief 400 mg tabletter fås i ALU/ALU- eller ALU/PVC-blisterkort i æsker med 7, 14 eller 28 tabletter.
English: Eslicarbazepine acetate metabolites are eliminated from the systemic circulation primarily by renal excretion, in the unchanged and glucuronide conjugate forms.
Danish: Eslicarbazepinacetats metabolitter udskilles primært fra det systemiske kredsløb via nyrerne i uændret form og som glukuronidkonjugater.
English: INFORMATION IN BRAILLE Exalief 400 mg
Danish: INFORMATION I BRAILLE-SKRIFT Exalief 400 mg
English: Exalief 600 mg tablets are packed in ALU/ALU or ALU/PVC blisters placed into cardboard boxes containing 30 or 60 tablets.
Danish: Exalief 600 mg tabletter fås i ALU/ALU- eller ALU/PVC-blisterkort i æsker med 30 eller 60 tabletter.
English: INFORMATION IN BRAILLE Exalief 800 mg (outer pack only)
Danish: INFORMATION I BRAILLE-SKRIFT Exalief 800 mg (kun på den ydre emballage)
English: INFORMATION IN BRAILLE Exalief 800 mg
Danish: INFORMATION I BRAILLE-SKRIFT Exalief 800 mg
English: Dizziness*, somnolence
Danish: Svimmelhed *, døsighed
English: INFORMATION IN BRAILLE Exalief 600 mg
Danish: INFORMATION I BRAILLE-SKRIFT Exalief 600 mg
English: The tablets are packaged in blisters in cardboard boxes containing 30 or 60 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.
Danish: Tabletterne er pakket i blisterkort i æsker med 30 eller 60 tabletter samt i HDPE-flasker med børnesikret lukning i æsker med 90 tabletter.
English: NAME OF THE MEDICINAL PRODUCT Exalief 400 mg tablets
Danish: LÆGEMIDLETS NAVN Exalief 400 mg tabletter
English: In a fertility study in male and female rats, impairment of female fertility by eslicarbazepine acetate was shown.
Danish: I et fertilitetsstudie med han- og hunrotter blev det påvist, at eslicarbazepin medførte nedsat fertilitet hos hunnerne.
English: Headache, abnormal coordination disturbance in attention, tremor
Danish: opmærksomh edsforstyrrels er, tremor
English: NAME OF THE MEDICINAL PRODUCT Exalief 800 mg tablets
Danish: LÆGEMIDLETS NAVN Exalief 800 mg tabletter
English: Liver centrilobular hypertrophy was seen in repeated dose toxicity studies in mice and rats and an increased incidence of liver tumours was observed in the carcinogenicity study in mice; these findings are consistent with an induction of hepatic microsomal enzymes, an effect which has not been observed in patients receiving eslicarbazepine acetate.
Danish: Der sås hepatisk centrilobulær hypertrofi i toksicitetsundersøgelser efter gentagne doser hos mus og rotter og en øget incidens af levertumorer i karcinogenicitetsstudiet hos mus.
English: This is just in case any of them interfere with how Exalief works or how Exalief interferes with their effect.
Danish: Dette er vigtigt, hvis den anden medicin påvirker Exaliefs virkning, eller Exalief påvirker den anden medicins virkning.
English: Eslicarbazepine in vivo may have an inducing effect on the metabolism of medicinal products that are mainly eliminated by conjugation through the UDP-glucuronyl transferases.
Danish: In vivo kan eslicarbazepin inducere metabolismen af lægemidler, der især udskilles ved konjugering via UDP-glukuronyltransferaser.
English: • Feeling generally unwell or having chills
Danish: • General utilpashed eller kuldegysninger
English: Exalief is not recommended if you have severe kidney problems.
Danish: De bør ikke tage Exalief , hvis De har en alvorlig nyresygdom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/020
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/09/520/020
English: Patients with liver problems
Danish: Patienter med dårlig lever
English: NAME OF THE MEDICINAL PRODUCT Exalief 600 mg tablets
Danish: LÆGEMIDLETS NAVN Exalief 600 mg tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/011
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/09/520/011
English: It is not known whether it passes into breast milk.
Danish: Det vides ikke, om Exalief udskilles i modermælk.
English: Exalief 800 mg tablets are packed in HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
Danish: Exalief 800 mg tabletter fås i HDPE-flasker med børnesikret lukning af polypropylen i æsker med 90 tabletter.
English: The tablets have ‘ESL 400'engraved on one side and are scored on the other side.
Danish: Tabletterne har 'ESL 400' præget på den ene side og delekærv på den anden side.