FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic groups: Other antiepileptics ATC code: N03AX12
Danish: Farmakoterapeutisk klassifikation: Andre antiepileptika, ATC-kode: N03AX12
English: Coadministration of gabapentin with antacids containing aluminium and magnesium, reduces gabapentin bioavailability up to 24%.
Danish: Samtidig administration af gabapentin og antacida, der indeholder aluminium og magnesium, nedsætter gabapentins biotilgængelighed med op til 24%.
English: Food, including a high-fat diet, has no clinically significant effect on gabapentin pharmacokinetics.
Danish: Fødeindtagelse, herunder diæt med højt fedtindhold, har ingen klinisk betydende virkning på gabapentins farmakokinetik.
English: the CHMP has recommended amendments of the Summary of Products Characteristic, Labelling and Package Leaflet, as set out in Annexe III of the CHMP opinion for Neurontin and associated names (see Annexe I of the opinion).
Danish: anbefaler CHMP ændring af produktresumé, etikettering og indlægsseddel, som det fremgår af bilag III til CHMPs udtalelse for Neurontin og tilknyttede navne (se bilag I til udtalelsen).
English: The usual dose to control epilepsy is 25-35 mg/kg/day.
Danish: Den normale dosis til kontrol af epilepsi er 25-35 mg/kg dagligt.
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Medicinen må ikke hældes i kloak eller smides ud med husholdningsaffald.
English: • Anorexia, increased appetite
Danish: • Appetitmangel, øget appetit
English: There are no adequate data from the use of gabapentin in pregnant women.
Danish: Der foreligger ikke tilstrækkelig data om brugen af gabapentin hos gravide.
English: Ireland c/o Pfizer Ltd.
Danish: Irland c/o Pfizer Ltd.
English: DOSAGE OF GABAPENTIN IN ADULTS BASED ON RENAL FUNCTION Creatinine Clearance (ml/min)
Danish: DOSERING AF GABAPENTIN HOS VOKSNE BASERET PÅ NYREFUNKTIONEN Kreatininclearance (ml/min)
English: Your doctor will prescribe [Neurontin and associated names] for you to help treat your epilepsy when your current treatment is not fully controlling your condition.
Danish: Deres læge vil udskrive [Neurontin og ledsagende navne] til behandling af Deres epilepsi, hvis Deres nuværende behandling ikke kan kontrollere Deres tilstand.
English: An oral lethal dose of gabapentin was not identified in mice and rats given doses as high as 8000 mg/kg.
Danish: En oral letaldosis af gabapentin er ikke identificeret hos mus og rotter ved doser på op til 8000 mg/kg.
English: Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/risk ratio of neurontin and associated names is favourable relating to:
Danish: På grundlag af den dokumentation, der er forelagt af indehaveren af markedsføringstilladelsen, og de faglige drøftelser i udvalget anser CHMP benefit/risk-forholdet for neurontin og tilknyttede navne for positivt ved anvendelse til:
English: Gabapentin should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus.
Danish: Gabapentin bør ikke anvendes under graviditet, medmindre fordelene for moderen klart opvejer den mulige risiko for fosteret.
English: A slight decrease in renal excretion of gabapentin that is observed when it is coadministered with cimetidine is not expected to be of clinical importance.
Danish: Et mindre fald i den renale udskillelse af gabapentin, som er set ved anvendelse sammen med cimetidin, ventes ikke at have klinisk betydning.
English: See leaflet for further information [This text will only be included on the labelling for the capsules]
Danish: [Denne tekst vil kun indgå i etikettering af kapslerne]
English: The relevance of these various actions of gabapentin to the anticonvulsant effects remains to be established.
Danish: Relevansen af disse mange virkninger af gabapentin på den antiepileptiske effekt er endnu ikke fastslået.
English: Floridsdorfer Hauptstraße 1 1210 Wien, Austria
Danish: Floridsdorfer Hauptstraße 1 1210 Wien, Østrig
English: • Blurred vision, double vision
Danish: • Sløret syn, dobbeltsyn
English: Reduced absorption of gabapentin at higher doses may limit drug absorption at the time of overdosing and, hence, minimize toxicity from overdoses.
Danish: Nedsat absorption af gabapentin ved høje doser kan begrænse absorptionen ved overdosering og dermed mindske den opnåede toksicitet.
English: Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Graviditet og amning Få vejledning hos lægen apoteket, før De tager nogen form for medicin.
English: If [Neurontin and associated names] and antacids containing aluminium and magnesium are taken at the same time, absorption of [Neurontin and associated names] from the stomach may be reduced.
Danish: Hvis [Neurontin og ledsagende navne] og midler mod for meget mavesyre, der indeholder aluminium og magnesium, tages på samme tid, vil optagelsen af [Neurontin og ledsagende navne] i maven nedsættes.
English: Ae% = Percent of dose excreted unchanged into the urine from time 0 to 8 hours postdose
Danish: Ae% = Procent af dosis udskilt uforandret i urinen fra tid 0-8 timer efter dosis NA = Ikke tilgængelig
English: 76139 Karlsruhe, Germany
Danish: 76139 Karlsruhe, Tyskland
English: • Feeling drowsy, dizziness, lack of coordination
Danish: • Følelse af døsighed, svimmelhed, manglende koordination
English: 150b-300 a Total daily dose should be administered as three divided doses.
Danish: 150b-300 a Den totale daglige dosis bør fordeles på 3 doser.
English: Important information about some of the ingredients of [Neurontin and associated names] The capsules contain lactose.
Danish: Vigtige oplysninger om visse af indholdsstofferne i [Neurontin og ledsagende navne] Kapslerne indeholder lactose.
English: Gabapentin partially reduces responses to the glutamate agonist N-methyl-D-aspartate (NMDA) in some test systems in vitro, but only at concentrations greater than 100 µM, which are not achieved in vivo.
Danish: Gabapentin nedsætter delvist virkningen af glutamatagonisten N-metyl-d-aspartat (NMDA) i nogle in vitro testsystemer, men kun ved koncentrationer højere end 100 µM.
English: If you stop taking [Neurontin and associated names] suddenly or before your doctor tells you, there is an increased risk of seizures.
Danish: Hvis De pludseligt stopper med at tage [Neurontin og ledsagende navne], eller før lægen fortæller Dem, at De skal stoppe behandlingen, er der en øget risiko for anfald.
English: Take the number of capsules or tablets as instructed by your doctor.
Danish: Tag det antal kapsler eller tabletter, som lægen har ordineret.
English: As with other antiepileptic medicinal products, some patients may experience an increase in seizure frequency or the onset of new types of seizures with gabapentin.
Danish: Som for andre antiepileptika kan visse patienter opleve en stigning i antallet af anfald, eller der opstår nye typer af anfald med gabapentin.
English: Pfizer Aps Lautrupvang 8 2750 Ballerup Denmark
Danish: Pfizer Aps Lautrupvang 8 2750 Ballerup Danmark
English: Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.
Danish: Hvis en bivirkning er set med forskellig hyppighed i kliniske undersøgelser, er den anført med den højeste hyppighed.
English: Gabapentin does not induce hepatic mixed function oxidase enzymes responsible for drug metabolism.
Danish: Gabapentin inducerer ikke hepatisk blandet funktionsoxidase-enzymer ansvarlig for lægemiddelmetabolisme.
English: - the scope of the referral was the harmonisation of the Summary of Product Characteristics, labelling and package leaflet - the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: Ud fra følgende betragtninger: - hensigten med indbringelsen af sagen var at harmonisere produktresuméet, etiketteringen og indlægssedlen - det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaveren af markedsføringstilladelsen, er blevet vurderet på grundlag af den forelagte dokumentation og de faglige drøftelse i udvalget,
English: In spite of these modest results, taking into consideration the adequate safety profile and the medical need in this paediatric population, the CHMP agreed to the following indication:
Danish: Trods disse beskedne resultater tilsluttede CHMP sig på baggrund af den tilfredsstillende sikkerhedsprofil og behandlingsbehovet hos denne pædiatriske population følgende indikation:
English: 1123 Budapest, Alkotás u. 53.
Danish: Pfizer Kft., 1123 Budapest, Alkotás u. 53.
English: Reduced dosages are for patients with renal impairment (creatinine clearance < 79 ml/min).
Danish: Nedsat dosis anbefales hos patienter med nedsat nyrefunktion (kreatininclearance < 79 ml/min).
English: Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but the precise mechanism of action of gabapentin is not yet known.
Danish: Gabapentin er strukturelt beslægtet med neurotransmitteren GABA (gammaaminosmørsyre), men dets nøjagtige virkningsmekanisme kendes endnu ikke.
English: c For patients with creatinine clearance <15 ml/min, the daily dose should be reduced in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 ml/min should receive one-half the daily dose that patients with a creatinine clearance of 15 ml/min receive).
Danish: c Hos patienter med kreatininclearance <15 ml/min, bør den daglige dosis nedsættes i forhold til kreatininclearance (f.eks. bør patienter med kreatininclearance på 7,5 ml/min have halv så stor daglig dosis, som patienter med kreatininclearance på 15 ml/min får).
English: Your doctor will usually build up your dose gradually.
Danish: Deres dosis vil gradvist blive øget.
English: Although gabapentin can be removed by haemodialysis, based on prior experience it is usually not required.
Danish: Selvom gabapentin kan elimineres ved hæmodialyse, er dette erfaringsmæssigt normalt ikke nødvendigt.
English: Pfizer Hellas A.E., Alketou 5, 11633 Athens Greece
Danish: Pfizer Hellas A.E., Alketou 5, 11633 Athen Grækenland
English: Also supplied as a titration pack for treatment of neuropathic pain containing 40 x 300 mg capsules and 10 x 600 mg tablets.
Danish: Findes også som en titreringspakning til behandling af neurogene smerter, som indeholder 40 x 300 mg kapsler og 10 x 600 mg tabletter.
English: Gabapentin administration to rats increases GABA turnover in several brain regions in a manner similar to valproate sodium, although in different regions of brain.
Danish: Gabapentin administreret til rotter øger GABAomsætningen i flere hjerneregioner på samme måde som natriumvalproat, om end i andre hjerneregioner.
English: A variety of different diseases can cause peripheral (primarily occurring in the legs and/or arms) neuropathic pain, such as diabetes or shingles.
Danish: Flere forskellige sygdomme kan være årsag til disse perifere neurogene smerter (opstår hovedsageligt i arme og/eller ben), f.eks. diabetes eller helvedesild.
English: The effects of long-term (greater than 36 weeks) gabapentin therapy on learning, intelligence, and development in children and adolescents have not been adequately studied.
Danish: Effekten af langstidsbehandling med gabapentin (mere end 36 uger) på indlæring, intelligens og udvikling hos børn og unge er ikke tilstrækkeligt undersøgt.
English: Gabapentin pharmacokinetics in children were determined in 50 healthy subjects between the ages of 1 month and 12 years.
Danish: Gabapentins farmakokinetik hos børn er fastsat hos 50 raske forsøgspersoner i alderen 1 måned til 12 år.
English: In one double blind study in patients with neuropathic pain, somnolence, peripheral oedema and asthenia occurred in a somewhat higher percentage in patients aged 65 years or above, than in younger patients.
Danish: I en dobbelt-blind undersøgelse hos patienter med neurogene smerter forekom søvnighed, perifert ødem og asteni hos en større procentdel af patienterne på 65 år eller derover end hos yngre patienter.
English: Regarding the indication in epilepsy as monotherapy, based on the published studies, the CHMP considered that, although not statistically significant for all studies, the results were sufficiently consistent to support the clinical efficacy and safety of gabapentin as monotherapy.
Danish: Vedrørende indikationen monoterapi ved epilepsi fandt CHMP, at resultaterne, uanset at de ikke var statistisk signifikante i alle undersøgelserne, var tilstrækkeligt konsistente til at underbygge den kliniske virkning og sikkerhed af gabapentin som monoterapi.
English: The elimination half-life of gabapentin is independent of dose and averages 5 to 7 hours.
Danish: Gabapentins eliminationshastighed er dosisuafhængig og er gennemsnitlig 5-7 timer.
English: The starting dose should range from 10 to 15 mg/kg/day and the effective dose is reached by upward titration over a period of approximately three days.
Danish: Initialdosis er 10-15 mg/kg dagligt, og den effektive dosis opnås ved dosistitrering over en periode på ca. 3 dage.
English: In a study involving healthy volunteers (N=12), when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine.
Danish: I en klinisk undersøgelse med raske frivillige (N=12), der fik 60 mg morfin depotkapsler 2 timer før 1 600 mg gabapentin kapsel, steg det gennemsnitlige AUC for gabapentin med 44% sammenlignet med gabapentin uden morfin.
English: AUC(0-8) = Steady state area under plasma concentration-time curve from time 0 to 8 hours postdose
Danish: AUC(0-8) = Steady state arealet under plasmakoncentrations-tidskurven fra tid 0-8 timer efter indgift af dosis
English: • Allergic reaction such as hives
Danish: • Allergiske reaktioner som f.eks. nældefeber
English: Additional post-hoc analyses of the responder rates by age did not reveal a statistically significant effect of age, either as a continuous or dichotomous variable (age groups 3-5 and 6-12 years).
Danish: Derudover afslører post-hoc analyser af responderrater efter alder ikke en statistisk effekt efter alder, hverken som vedvarende eller dikotomisk variabel (aldersgruppe 3-5 år og 6-12 år).
English: [Neurontin and associated names] is not recommended for use in children below 6 years of age.
Danish: [Neurontin og ledsagende navne] bør ikke anvendes hos børn under 6 år.
English: Epilepsy:
Danish: Epilepsi:
English: Steady state plasma gabapentin concentrations are predictable from single-dose data.
Danish: Gabapentins steady state plasmakoncentrationer kan forudsiges ud fra en enkeltdosis.
English: • Blood glucose fluctuations in patients with diabetes, abnormal blood test results suggesting problems with the liver.
Danish: • Svingende blodsukkerniveau hos diabetikere, abnorme blodprøveresultater, som tyder på leverproblemer.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Bivirkningerne inden for hver hyppighed er anført efter faldende alvorlighed.
English: Gabapentin bioavailability (fraction of dose absorbed) decreases with increasing dose which imparts non-linearity to pharmacokinetic parameters which include the bioavailability parameter (F) e.g. Ae%, CL/F, Vd/F.
Danish: Gabapentins biotilgængelighed (fraktion af absorberet dosis) falder, når dosis stiger, hvilket overfører nonlinearitet til farmakokinetiske parametre, som omfatter biotilgængeligheds-parameter (F) dvs. Ae%, CL/F, Vd/F.
English: If a patient develops acute pancreatitis under treatment with gabapentin, discontinuation of gabapentin should be considered (see section 4.8).
Danish: Hvis en patient udvikler akut pancreatitis under behandling med gabapentin, bør seponering af gabapentin overvejes (se pkt.
English: In patients with epilepsy, gabapentin concentrations in cerebrospinal fluid (CSF) are approximately 20% of corresponding steady-state trough plasma concentrations.
Danish: Hos patienter med epilepsi er gabapentinkoncentrationen i cerebrospinalvæsken ca. 20% af den tilsvarende laveste plasmakoncentration ved steady state.
English: Gabapentin elimination-rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance.
Danish: Gabapentins eliminationshastighedskonstant, plasmaclearance og renal-clearance er direkte proportionel med kreatininclearance.
English: • Problems with abnormal movements such as writhing, jerking movements and stiffness
Danish: • Problemer med abnorme bevægelser, såsom vridninger, rykvise bevægelser og stivhed
English: Regarding epilepsy, the indication as adjunctive therapy in children aged 3 years and above as well as the indication as monotherapy were debated.
Danish: Vedrørende epilepsi drøftedes indikationen supplerende behandling af børn over 3 år samt indikationen som monoterapi.
English: Further, gabapentin may be used in combination with other antiepileptic medicinal products without concern for alteration of the plasma concentrations of gabapentin or serum concentrations of other antiepileptic medicinal products.
Danish: Derudover kan gabapentin anvendes sammen med andre antileptika uden at plasmaniveauet af gabapentin eller serumkoncentrationen af andre antiepileptika forandres.
English: Respiratory tract infections, otitis media, convulsions and bronchitis were reported only in clinical studies in children.
Danish: Der er kun set luftvejsinfektioner, otitis media, konvulsioner og bronkitis i kliniske undersøgelser hos børn.
English: In clinical trials, the effective dosing range was 900 to 3600 mg/day.
Danish: I kliniske undersøgelser er det effektive dosisinterval 900-3600 mg/dag.
English: The effective dose of gabapentin in children aged 6 years and older is 25 to 35 mg/kg/day.
Danish: Den effektive dosis af gabapentin hos børn på 6 år og derover er 25-35 mg/kg dagligt.
English: The dose to be given to your child will be decided by your doctor as it is calculated against your child's weight.
Danish: Lægen vil fastsætte Deres barns dosis på baggrund af barnets vægt.
English: In general, plasma gabapentin concentrations in children > 5 years of age are similar to those in adults when dosed on a mg/kg basis.
Danish: Gabapentins plasmakoncentration hos børn >5 år er den samme som hos voksne, når dosis er beregnet i mg/kg.
English: • Viral infection
Danish: viral infektion
English: In addition, the clinical data support of the starting dose, the titration schedule, and the maximum total daily dosage of 3600 mg administered in three doses.
Danish: De kliniske data underbygger desuden startdoseringen, dosistitreringsplanen og den maksimale totale dagsdosis på 3600 mg, fordelt på tre doser.
English: − Keep this leaflet.
Danish: - Gem denne indlægsseddel.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE [To be completed nationally]
Danish: UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE [Udfyldes nationalt]
English: A clinical trial of adjunctive treatment of partial seizures in paediatric subjects, ranging in age from 3 to 12 years, showed a numerical but not statistically significant difference in the 50% responder rate in favour of the gabapentin group compared to placebo.
Danish: En klinisk undersøgelse af supplerende behandling af partiel epilepsi hos børn i alderen 3-12 år, viser en nummerisk, men ikke statistisk signifikant forskel i den 50% responderrate til fordel for gabapentingruppen sammenlignet med placebo.
English: < 6 Years Old 6 to 12 Years Old 17/99 (17.2%)
Danish: <6 år 6-12 år
English: impotence
Danish: impotens
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg Deres apotek om, hvad De skal gøre ved eventuelt overskydende medicin.
English: [Neurontin and associated names] belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain.
Danish: [Neurontin og ledsagende navne] tilhører den gruppe medicin, der anvendes til behandling af epilepsi og perifere neurogene smerter.
English: The relevance of these pancreatic acinar cell tumors in male rats to carcinogenic risk in humans is unclear.
Danish: Det er uklart om disse acinære celletumorer i pankreas hos hanrotter har relevans for den karcinogene risiko hos mennesker.
English: Continue taking [Neurontin and associated names] until your doctor tells you to stop.
Danish: De skal fortsætte med at tage [Neurontin og ledsagende navne], indtil Deres læge beder Dem om at stoppe.
English: What [Neurontin and associated names] is and what it is used for Before you take [Neurontin and associated names] How to take [Neurontin and associated names] Possible side effects
Danish: Hvad [Neurontin og ledsagende navne] er, og hvad det anvendes til Hvad De skal gøre, før De begynder at tage [Neurontin og ledsagende navne] Hvordan De tager [Neurontin og ledsagende navne] Hvilke mulige bivirkninger [Neurontin og ledsagende navne] har Hvordan De opbevarer [Neurontin og ledsagende navne] Yderligere information
English: • Feeling tired, fever
Danish: • Følelse af træthed, feber
English: Coadministration of gabapentin with oral contraceptives containing norethindrone and/or ethinyl estradiol, does not influence the steady-state pharmacokinetics of either component.
Danish: Samtidig administration af gabapentin og orale kontraceptiva, der indeholder norethindron og/eller ethinyl østradiol, påvirker ikke disse stoffers steady state farmakokinetik.
English: Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day.
Danish: På baggrund af patientens respons og tolerans, kan dosis derefter øges med en dosistilvækst på 300 mg dagligt hver 2.-3. dag op til maksimalt 3600 mg dagligt.
English: Dosages up to 4800 mg/day have been well tolerated in long-term open-label clinical studies.
Danish: Doser på op til 4800 mg dagligt var veltålt i åbne langtidsundersøgelser.
English: Film-coated tablet [Description to be completed nationally]
Danish: Filmovertrukne tabletter [Beskrivelse udfyldes nationalt]
English: allergic reactions (e.g. urticaria) Metabolism and Nutrition Disorders Common:
Danish: allergiske reaktioner (f.eks. urticaria) Stofskiftesygdomme og ernæringsbetingede sygdomme Almindelig:
English: movement disorders (e.g. choreoathetosis, dyskinesia, dystonia)
Danish: forstyrrelser i bevægeapparatet (f.eks. choreoatetose, dyskinesi, dystoni)
English: It was not mutagenic in vitro in standard assays using bacterial or mammalian cells.
Danish: Det er ikke mutagent in vitro ved standardundersøgelser med bakterietest eller pattedyrsceller.
English: Because the effect on the breast-fed infant is unknown, caution should be exercised when gabapentin is administered to a breast-feeding mother.
Danish: Da effekten på det ammede barn ikke kendes tilrådes forsigtighed, når gabapentin anvendes til ammende mødre.
English: The therapy may be initiated by titrating the dose as described in Table 1.
Danish: Behandlingen indledes med dosistitrering, som anført i tabel 1.
English: PHARMACEUTICAL FORM Capsule, hard
Danish: LÆGEMIDDELFORM Hårde kapsler.
English: Gabapentin does not interact with sodium channels in vitro and so differs from phenytoin and carbamazepine.
Danish: Gabapentin interagerer ikke med natriumkanaler in vitro og adskiller sig derved fra phenytoin og carbamazepin.
English: Always swallow the capsules or tablets whole with plenty of water.
Danish: Kapslerne eller tabletterne skal sluges hele og indtages med rigeligt vand.
English: Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 g. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, lethargy and mild diarrhoea.
Danish: Akut livstruende toksicitet er ikke observeret med gabapentin ved overdosering på op til 49 g. Symptomer ved overdosering er svimmelhed, dobbeltsyn, talebesvær, døsighed, letargi og mild diarré.