FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended monotherapy dosage of 100 - 200 mg/day as the initial target dose and the maximum daily dose of 500mg/day in monotherapy in adults, and the initial target dose of 100 mg/day depending on clinical response in children aged 6 years and above was endorsed by the CHMP for use.
Danish: CHMP godkendte brugen af den anbefalede monoterapidosis på 100-200 mg om dagen som indledende måldosis og en maksimal dagsdosis på 500 mg som monoterapi hos voksne samt en indledende måldosis på 100 mg om dagen afhængigt af den kliniske respons hos børn over 6 år.
English: Information on dosing in patients with hepatic impairment has also been provided.
Danish: Der gives ligeledes informationer om dosering til patienter med nedsat leverfunktion.
English: Vision blurred, diplopia, visual disturbance
Danish: Slørret syn, diplopi, synsforstyrrelser
English: 50 hard capsules
Danish: 50 hårde kapsler.
English: The results of this study indicated that metformin mean Cmax and mean AUC0-12h increased by 18% and 25%, respectively, while mean CL/F decreased 20% when metformin was co-administered with topiramate.
Danish: Metformins gennemsnitlige Cmax og gennemsnitlige AUC0-12h steg med henholdsvis 18% og 25%, mens den gennemsnitlige CL/F (clearance/biotilgængelighed) faldt 20%, når metformin og topiramat blev givet sammen.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: UDLØBSDATO Udløbsdato SÆRLIGE OPBEVARINGSBETINGELSER [Udfyldes nationalt] EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: • Reduced sense of touch or sensation
Danish: • Nedsat følesans eller nedsat følelse ved berøring
English: • Leakage of urine and/or stools
Danish: • Ufrivillig vandladning og/eller afføring
English: Paediatric population (children aged 2 years and above)
Danish: Børn (fra 2 år)
English: Indication Migraine Prophylaxis
Danish: Indikation migræneprofylakse
English: The addition or withdrawal of phenytoin or carbamazepine to Topamax therapy may require an adjustment in dosage of the latter.
Danish: Tillæg eller seponering af phenytoin eller carbamazepin til Topimaxbehandling kan kræve en justering af Topimaxdosis.
English: If the patient is unable to tolerate the titration regimen, smaller increments or longer intervals between increments can be used.
Danish: Hvis patienten ikke tåler titreringsregimet, kan en mindre dosisforøgelse eller længere intervaller mellem dosisøgning anvendes.
English: • Muscle spasms, muscle twitching or muscle weakness
Danish: • Muskelkramper, muskeltrækninger eller muskelsvaghed
English: Very common side effects include:
Danish: Meget almindelige bivirkninger:
English: Leucopenia, thrombocytopenia lymphadenopathy, eosinophilia
Danish: Leukopeni, trombocytopeni, lymfadenopati, eosinofili,
English: Depression Bradyphrenia, insomnia, expressive language disorder, anxiety, confusional state, disorientation, aggression, mood altered, agitation, mood swings, depressed mood, anger, abnormal behaviour
Danish: Depression Bradyfreni, søvnløshed, ekspressive sprogforstyrrelser, angst, desorientering, forvirring, aggression, humørændring, agitation, humørsvingninger, nedtrykthed, vrede, unormal opførsel
English: These dosing recommendations apply to all adults, including the elderly, in the absence of underlying renal disease (see section 4.4).
Danish: Ovenstående doseringsvejledning gælder alle voksne, inklusive ældre uden nyresygdomme (se pkt.
English: • Skin rash and/or itchy skin.
Danish: • Hududslæt og/eller kløende hud
English: Belgium Janssen-Cilag NV - BE
Danish: Janssen-Cilag NV - BE
English: The recommended initial target dose for topiramate monotherapy in adults is 100 mg/day to 200 mg/day in 2 divided doses.
Danish: Den anbefalede initiale måldosis ved monoterapi hos voksne er 100-200 mg/døgn fordelt på 2 doser.
English: Concomitant Drug Concentrationa
Danish: Koncentration af samtidigt administreret lægemiddela
English: 28 hard capsules
Danish: 28 hårde kapsler.
English: - the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: - Produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets faglige drøftelse anbefaler CHMP en ændring af markedsføringstilladelserne for Topimax og tilknyttede navne (se bilag I).
English: Carbamazepine (CBZ) Valproic acid Lamotrigine Phenobarbital
Danish: Carbamazepin (CBZ) Valproat
English: Addition or withdrawal of phenytoin and carbamazepine to adjunctive therapy with Topamax may require adjustment of the dose of Topamax.
Danish: Addering eller seponering af phenytoin eller carbamazepin ved adjuverende behandling med Topimax kan nødvendiggøre en justering af topiramatdosis.
English: There is undoubtedly statistically significant evidence of efficacy seen in the paediatric population as a whole to support the adjunctive therapy indication in children with POS, PGTS, or LGS seizure types.
Danish: Der er utvivlsomt statistisk signifikant evidens for virkningen hos den pædiatriske population som helhed til støtte for tillægsbehandlingsindikationen for børn med partielle anfald, primært generaliserede tonisk-kloniske anfald eller Lennox-Gastauts syndrom.
English: Clinical laboratory results indicated decreases in serum potassium after topiramate or HCTZ administration, which were greater when HCTZ and topiramate were administered in combination.
Danish: Efter administration af topiramat eller hydrochlorthiazid indikerede laboratorieanalyser et fald i serum-kalium, som var større, når topiramat og hydrochlorthiazid blev givet sammen.
English: Janssen-Cilag NV - BE Roderveldlaan 1 2600 Berchem, Belgium
Danish: Janssen-Cilag NV - BE Roderveldlaan 1 2600 Berchem, Belgien
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: <{Medlemslandets navn}> <{Lægemidlets navn}> <{Medlemslandets navn}> <{Lægemidlets navn}> Denne indlægsseddel blev senest godkendt { MM/ÅÅÅÅ } [Udfyldes nationalt]
English: The usual daily dose is 200-400 mg in two divided doses.
Danish: Den normale døgndosis er 200-400 mg fordelt på 2 doser.
English: In patients with end-stage renal failure, since topiramate is removed from plasma by haemodialysis, a supplemental dose of Topamax equal to approximately one-half the daily dose should be administered on haemodialysis days.
Danish: Patienter med nyresvigt i slutstadie bør på dialysedagene have dosis suppleret med en dosis svarende til ca. halvdelen af den daglige dosis, da topiramat elimineres fra plasma under hæmodialyse.
English: Pharmacotherapeutic group: other antiepileptics, antimigraine preparations, ATC code: N03AX11
Danish: ATC-kode: N03AX11
English: When Topamax is added or withdrawn in patients on digoxin therapy, careful attention should be given to the routine monitoring of serum digoxin.
Danish: Når topiramat tillægges eller seponeres fra en patient i digoxinbehandling, bør der derfor være en skærpet opmærksomhed på den rutinemæssige monitorering af serum-digoxin.
English: Rare side effects include:
Danish: Sjældne bivirkninger:
English: 60 hard capsules
Danish: 60 hårde kapsler.
English: Learning disability
Danish: Indlæringsvanskeligheder
English: A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of HCTZ (25 mg q24h) and topiramate (96 mg q12h) when administered alone and concomitantly.
Danish: Hos raske forsøgspersoner blev steady-state farmakokinetikken af hydrochlorthiazid (25 mg daglig) og topiramat (96 mg 2 gange daglig) evalueret, når de blev givet alene og samtidig.
English: • Shortness of breath
Danish: • Dårlig ånde
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Plastic bottle
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Box for plastikbeholder
English: 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally]
Danish: 6.2 Uforligeligheder [udfyldes nationalt]
English: Dyspnoea , epistaxis, nasal congestion, rhinorrhoea
Danish: Dyspnø, epistaxis, tilstoppet næse, rinoré
English: The dosage should then be increased in increments of 25 mg/day administered at 1-week intervals.
Danish: Dosis bør derefter øges med 25 mg/døgn med en uges interval.
English: Monotherapy for epilepsy
Danish: Monoterapi ved epilepsi
English: Signs and symptoms included convulsions, drowsiness, speech disturbances, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression.
Danish: Symptomer inkluderede kramper, sløvhed, taleforstyrrelser, sløret syn, dobbeltsyn, nedsat tankevirksomhed, letargi, unormal koordinationsevne, stupor, hypotension, abdominalsmerter, agitation, svimmelhed og depression.
English: Topamax may make your birth control pills less effective.
Danish: Topimax kan nedsætte virkningen af p-piller.
English: When enzyme inducing medicinal products are withdrawn, topiramate levels will increase.
Danish: Når enzyminducerende lægemidler seponeres, vil plasmakoncentration af topiramat stige, og nedsættelse af topiramatdosis kan være nødvendig.
English: ADRs reported more frequently (≥2-fold) in children than in adults in double-blind controlled studies include: decreased appetite, increased appetite, acidosis hyperchloraemic, hypokalaemia, abnormal behaviour, aggression, apathy, initial insomnia, suicidal ideation, disturbance in attention, lethargy, circadian rhythm sleep disorder, poor quality sleep, lacrimation increased, sinus bradycardia, feeling abnormal, and gait disturbance.
Danish: Bivirkninger, som er hyppigere rapporteret hos børn (mere end dobbelt så hyppigt) end hos voksne i dobbelt-blindede forsøg, inkluderer: nedsat appetit, øget appetit, hyperkloræmisk acidose, hypokaliæmi, unormal opførsel, aggression, apati, initial søvnløshed, selvmordstanker, uopmærksomhed, letargi, søvnforstyrrelser i forhold til cirkadisk rytme, dårlig søvnkvalitet, tåreflåd, sinusbradykardi, følelse af at være unormal og gangforstyrrelser.
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication.
Danish: Topimax indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsoprtion.
English: • Painful urination
Danish: • Smertefuld vandladning
English: • Take Topamax exactly as prescribed.
Danish: • Tag Topimax nøjagtigt efter lægens anvisning.
English: • Swelling in the tissues around the eye
Danish: • Hævelse omkring øjnene
English: In animal studies, topiramate exhibits anticonvulsant activity in rat and mouse maximal electroshock seizure (MES) tests and is effective in rodent models of epilepsy, which include tonic and absence-like seizures in the spontaneous epileptic rat (SER) and tonic and clonic seizures induced in rats by kindling of the amygdala or by global ischemia.
Danish: Disse forsøg omfatter toniske og absencelignende anfald hos spontant epileptiske rotter (SER) og toniske og kloniske kramper induceret i rotter ved amygdala-kindling eller ved global iskæmi.
English: Pyrexia, asthenia, irritability, gait disturbance, feeling abnormal, malaise
Danish: Feber, asteni, irritabilitet, gangforstyrrels er, følelsen af at være unormal, utilpashed
English: Therapy should begin at 25-50 mg nightly for one week.
Danish: Behandlingen bør starte med 25-50 mg hver aften i en uge.
English: Paraesthesia, somnolence Dizziness
Danish: Paræstesi, døsighed, svimmelhed
English: Vomiting, constipation, abdominal pain upper, dyspepsia, abdominal pain, dry mouth, stomach discomfort, paraesthesia oral, gastritis, abdominal discomfort
Danish: Opkastning, forstoppelse, øvre abdominalsmerte, dyspepsi, abdominalsmerte, mundtørhed, ubehag i maven, oral paræstesi, gastritis, abdominalt ubehag
English: Topamax is available in film-coated tablets and a hard capsule formulation.
Danish: Topimax findes som filmovertrukne tabletter og som hårde kapsler.
English: Crystal urine present, tandem gait test abnormal, white blood cell count decreased
Danish: Vægtøgning* Krystaller i urinen, tandem gangtest unormal, nedsat antal hvide blodlegemer
English: • This medicine has been prescribed for you.
Danish: • Lægen har ordineret Topimax til dig personligt.
English: Disturbance in attention, memory impairment, amnesia, cognitive disorder, mental impairment, psychomotor skills impaired, convulsion, coordination abnormal, tremor, lethargy, hypoaesthesia, nystagmus, dysgeusia, balance disorder, dysarthria, intention tremor, sedation ,
Danish: Uopmærksomhed, hukommelsessvækkelse, amnesi, kognitiv lidelse, mental svækkelse, nedsatte psykomotoriske evner, kramper, unormal koordinationsevne, tremor, letargi, hypæstesi, nystagmus, dysgeusi, ballanceforstyrrelser, dysartri, intentions tremor, sedation
English: Monotherapy epilepsy
Danish: Monoterapi af epilepsi
English: If the patient is unable to tolerate the titration regimen, longer intervals between dose adjustments can be used.
Danish: Hvis patienten ikke kan tåle denne titrering, kan intervallerne mellem dosisøgningerne øges.
English: Comprimidos recubiertos
Danish: Overtrukne tabletter
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name}
Danish: LÆGEMIDLETS NAVN [Se bilag I - Udfyldes nationalt]
English: Depressed level of consciousness, grand mal convulsion, visual field defect, complex partial seizures, speech disorder, psychomotor hyperactivity, syncope, sensory disturbance, drooling, hypersomnia, aphasia, repetitive speech, hypokinesia, dyskinesia, dizziness postural, poor quality sleep, burning sensation, sensory loss, parosmia, cerebellar syndrome, dysaesthesia, hypogeusia, stupor, clumsiness, aura, ageusia, dysgraphia, dysphasia, neuropathy peripheral, presyncope, dystonia,
Danish: Bevidsthedssvækkelse, grand mal kramper, defekt synsfelt, komplekse partielle anfald, taleforstyrrelser, psykomotorisk hyperaktivitet, synkope, føleforstyrrelser, savlen, hypersomni, afasi, ensformig tale, hypokinesi, dyskinesi, postural svimmelhed, dårlig søvnkvalitet, brændende fornemmelse, tab af følelse, parosmi, cerebellart syndrom, dysæstesi, hypogeusi, stupor, klodsethed, aura, ageusi, dysgrafi, dysfasi, perifer neuropati, presynkope, dystoni, myrekryb
English: • have a growth problem
Danish: • har problemer med højdevæksten
English: The most common ADRs (those with an incidence of >5% and greater than that observed in placebo in at least 1 indication in double-blind controlled studies with topiramate) include: anorexia, decreased appetite, bradyphrenia, depression, expressive language disorder, insomnia, coordination abnormal, disturbance in attention, dizziness, dysarthria, dysgeusia, hypoesthesia, lethargy, memory impairment, nystagmus, paresthesia, somnolence, tremor, diplopia, vision blurred, diarrhoea, nausea, fatigue, irritability, and weight decreased.
Danish: De mest almindelige bivirkninger (hyppighed >5% eller mere end observeret ved placebo) ved mindst en indikation i dobbelt-blindede kontrollerede forsøg med topiramat inkluderer: anoreksi, nedsat appetit, bradyfreni, depression, ekspressive sprogforstyrrelser , søvnløshed, unormal koordinationsevne, uopmærksomhed, svimmelhed, dysartri, dysgeusi, hypæstesi, letargi,
English: • Musculoskeletal stiffness
Danish: • Muskel- og knoglestivhed
English: Primidone
Danish: Primidon
English: • Odour
Danish: • Lugt
English: Belgium Janssen-Cilag NV - BE Roderveldlaan 1 B-2600 Berchem, Belgium
Danish: Janssen-Cilag NV - BE Roderveldlaan 1 B-2600 Berchem, Belgien
English: Suicidal ideation, suicide attempt, hallucination, psychotic disorder, hallucination auditory, hallucination visual, apathy, lack of spontaneous speech, sleep disorder, affect lability, libido decreased, restlessness, crying, dysphemia, euphoric mood, paranoia, perseveration, panic attack, tearfulness, reading disorder, initial insomnia, flat affect, thinking abnormal, loss of libido, listless, middle insomnia, distractibility, early morning awakening, panic reaction, elevated mood
Danish: Selvmordstanker, selvmordsforsøg, hallucinationer, psykiske forstyrrelser, auditive hallucinationer, visuelle hallucinationer, apati, tab af spontan tale, søvnforstyrrelser, affektlabilitet, nedsat libido, rastløshed, grådlabilitet, dysfemi, eufori, paranoia, perseveration, panikanfald, let til tårer, læsebesvær, initial søvnløshed, manglende affekt, unormal tankegang, tab af libido, manglende interesse, moderat søvnløshed, distraktion, vågner tidligt, panisk reagerende, opstemthed mani, anorgasmi, paniklidelser, nedsat seksuel opstemthed, modløshed*, unormal orgasme, hypomani, nedsat orgasme
English: • Weight gain
Danish: • Vægtstigning
English: • Swollen glands in the neck armpit or groin
Danish: • Hævede lymfeknuder på halsen, i armhulerne eller i lysken
English: • Impaired or distorted sense of smell
Danish: • Nedsat eller ændret lugtesans
English: The recommended total daily dose of topiramate for prophylaxis of migraine headache is 100 mg/day administered in two divided doses.
Danish: Den anbefalede døgndosis topiramat til migræneprofylakse er 100 mg/døgn fordelt på 2 doser.
English: • alone to treat seizures in adults and children over age 6
Danish: • som eneste medicin til behandling af epilepsi (kramper) hos voksne og børn over 6 år.
English: Adjunctive therapy epilepsy (partial onset seizures with or without secondary generalization, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome)
Danish: Adjuverende behandling ved epilepsi (med partielle epileptiske anfald med eller uden sekundære generalisede anfald, primære generaliserede tonisk-kloniske anfald eller anfald i forbindelse med Lennox-Gastaut syndrom).
English: b a % values are the changes in treatment mean Cmax or AUC with respect to monotherapy ↔ = No effect on Cmax and AUC (≤ 15% change) of the parent compound NS = Not studied *DEA = des acetyl diltiazem, DEM = N-demethyl diltiazem b Flunarizine AUC increased 14% in subjects taking flunarizine alone.
Danish: * DEA = desacetyldiltiazem, DEM = N-demethyldiltiazem b Flunarizine AUC blev øget med 14% hos personer, der tog flunarizin alene.
English: Joint swelling*, musculoskeletal stiffness, flank pain, muscle fatigue
Danish: Hævelse af led*, muskuloskeletal stivhed, flankesmerter, muskeltræthed
English: • Skin discolouration
Danish: • Misfarvning af huden
English: Topamax and associated names (see Annex I) 25, 50, 100 and200 mg film-coated tablets Topamax and associated names 15, 25 and 50 mg hard capsules
Danish: Topimax og tilhørende navne (se bilag I) 25 mg, 50 mg, 100 mg eller 200 mg filmovertrukne tabletter Topimax og tilhørende navne (se bilag I) 15 mg, 25 mg og 50 mg hårde kapsler
English: Pancreatitis, flatulence, gastrooesophageal reflux disease, abdominal pain lower, hypoaesthesia oral, gingival bleeding, abdominal distension, epigastric discomfort, abdominal tenderness, salivary hypersecretion, oral pain, breath odour, glossodynia
Danish: Pancreatitis, flatulens, gastroøsofageal reflux, nedre abdominalsmerte, oral hypæstesi, gingivalblødning, abdominal distension, epigastrisk ubehag, abdominal ømhed, hypersekretion af spyt, oral smerte, dårlig ånde, glossodyni,
English: Nasopharyngitis
Danish: Nasofaryngitis*
English: The dosage should then be increased at 1 or 2 week intervals by increments of 0.5 to 1 mg/kg/day, administered in two divided doses.
Danish: Dosis bør herefter øges hver eller hver anden uge med 0,5-1 mg/kg/døgn fordelt på 2 doser.
English: Do not take Topamax
Danish: Tag ikke Topimax
English: DATE OF REVISION OF THE TEXT
Danish: DATO FOR ÆNDRING AF TEKSTEN [Udfyldes nationalt]
English: Queluz de Baixo 2734-503 Barcarena Portugal
Danish: Estrada Consiglieri Pedroso, 69 AQueluz de Baixo 2734-503 Barcarena Portugal
English: Acidosis hyperchloraemic
Danish: Hyperkloræmisk acidose
English: • Tingling in the arms and legs
Danish: • Prikkende, snurrende fornemmelser i arme og ben
English: Investigations Weight decreased
Danish: Undersøgelser Vægttab
English: In hepatically-impaired patients, topiramate should be administered with caution as the clearance of topiramate may be decreased.
Danish: Ved nedsat leverfunktion bør topiramat administreres med forsigtighed, da udskillelsen af topiramat kan være nedsat.
English: The addition of HCTZ to topiramate therapy may require an adjustment of the topiramate dose.
Danish: Gives hydrochlorthiazid i tillæg til topiramat, kan det være nødvendigt at justere topiramatdosis.
English: Decreased hepatic function
Danish: Nedsat nyrefunktion
English: Topamax and associated names (see Annex I) 25 mg film-coated tablets Topamax and associated names (see Annex I) 50 mg film-coated tablets Topamax and associated names (see Annex I) 100 mg film-coated tablets Topamax and associated names (see Annex I) 200 mg film-coated tablets
Danish: Topimax og tilhørende navne (se bilag I) 25 mg filmovertrukne tabletter Topimax og tilhørende navne (se bilag I) 50 mg filmovertrukne tabletter Topimax og tilhørende navne (se bilag I) 100 mg filmovertrukne tabletter Topimax og tilhørende navne (se bilag I) 200 mg filmovertrukne tabletter Topimax og tilhørende navne (se bilag I) 15 mg hårde kapsler Topimax og tilhørende navne (se bilag I) 25 mg hårde kapsler Topimax og tilhørende navne (se bilag I) 50 mg hårde kapsler [Se bilag I - Udfyldes nationalt]
English: UAB Johnson & Johnson Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania
Danish: UAB Johnson & Johnson Šeimyniškių g. 1A, LT-09312 Vilnius, Litauen
English: Some patients may achieve efficacy with once-a-day dosing.
Danish: Nogle patienter kan opnå god anfaldskontrol med dosering 1 gang i døgnet.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Plastic bottle
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Plastikbeholder
English: What Topamax is and what it is used for Before you take Topamax How to take Topamax Possible side effects How to store Topamax Further information
Danish: Det skal du vide, før du begynder at tage Topimax Sådan skal du tage Topimax Bivirkninger
English: A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly.
Danish: Hos raske forsøgspersoner blev steady-state farmakokinetikken af topiramat og pioglitazon evalueret, når de blev givet alene og samtidig.
English: In addition, a statement on the interaction of topiramate with St John's Wort was also included in the Product Information.
Danish: Herudover blev der i produktinformationen indføjet et stykke om topiramats interaktion med perikum.
English: UAB Johnson & Johnson - LT Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania
Danish: UAB Johnson & Johnson - LT Šeimyniškių g.1A, LT-09312 Vilnius, Litauen
English: • Changes in thinking and alertness, including confusion, problems with concentration, memory or slowness in thinking
Danish: koncentrationsproblemer, hukommelsesbesvær eller langsom tankevirksomhed
English: 56 film-coated tablets with desiccant
Danish: 56 filmovertrukne tabletter med tørremiddel.
English: ”Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome.”
Danish: ”Tillægsbehandling hos børn over 2 år, voksne og unge, som lider af partielle anfald med eller uden sekundær generalisering eller primært generaliserede tonisk-kloniske anfald, og behandling af anfald i forbindelse med Lennox-Gastauts syndrom.”
English: Allergic oedema*, conjunctival oedema*
Danish: Allergisk ødem*, konjunktivalt ødem*