FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of birth defects is increased by a factor of 2 - 3 in the offspring of mothers treated with an antiepileptic medicinal product.
Danish: Risikoen for misdannelser hos børn af mødre behandlet med antiepileptika øges med en faktor på 2-3.
English: Gabapentin 100 mg capsules can be used to follow dosing recommendations for patients with renal insufficiency.
Danish: Gabapentin 100 mg kapsler kan anvendes hos patienter med nyreinsufficiens for at kunne følge dosisanbefalingerne.
English: Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms.
Danish: Gabapentin virker på centralnervesystemet, og kan fremkalde omtågethed, svimmelhed eller andre lignende symptomer.
English: For renally impaired patients undergoing haemodialysis, the maintenance dose of gabapentin should be based on the dosing recommendations found in Table 2.
Danish: Patienter med nedsat nyrefunktion, der er i hæmodialysebehandling, bør vedligeholdelsesdosis af gabapentin baseres på dosisanbefalingerne i tabel 2.
English: Signs of acute toxicity in animals included ataxia, laboured breathing, ptosis, hypoactivity, or excitation.
Danish: Tegn på akut toksicitet hos dyr omfatter ataksi, vejrtrækningsbesvær, ptose, hypoaktivitet eller ekscitation.
English: In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced.
Danish: Hos ældre patienter samt patienter med nedsat nyrefunktion er gabapentins plasmaclearance nedsat.
English: Gabapentin bioavailability (fraction of dose absorbed) tends to decrease with increasing dose.
Danish: Gabapentins biotilgængelighed (fraktion af absorberet dosis) falder, når dosis stiger.
English: Renal excretion of gabapentin is unaltered by probenecid.
Danish: Den renale udskillelse af gabapentin påvirkes ikke af probenecid.
English: Gabapentin should be used in breast-feeding mothers only if the benefits clearly outweigh the risks.
Danish: Gabapentin bør kun anvendes af ammende, hvis fordelene klart opvejer risiciene for barnet.
English: Please 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 lægen eller apoteket, hvis De tager anden medicin eller har taget det for nylig.
English: Gabapentin induced delayed ossification in the skull, vertebrae, forelimbs, and hindlimbs in rodents, indicative of fetal growth retardation.
Danish: Gabapentin medfører forsinket ossifikation i kraniet, ryghvirvler, forbens- og bagbensknogler hos gnavere, hvilket indikerer føtal vækstretardering.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine [this text will only be included in the capsules SPC].
Danish: Denne medicin bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption [denne tekst vil kun indgå i produktresumeet for kapslerne].
English: Gabapentin did not increase the incidence of malformations, compared to controls, in the offspring of mice, rats, or rabbits at doses up to 50, 30 and 25 times respectively, the daily human dose of 3600 mg, (four, five or eight times, respectively, the human daily dose on a mg/m2 basis).
Danish: Gabapentin øger ikke forekomsten af misdannelser, sammenlignet med kontrolgruppen, hos afkom af mus, rotter eller kaniner ved doser op til henholdsvis 50, 30 og 25 gange den daglige dosis til mennesker på 3600 mg (henholdsvis 4, 5 og 8 gange dosis til mennesker omregnet til mg/m2 på basis af kroppens overfladeareal).
English: [Neurontin and associated names] is not expected to interact with other antiepileptic drugs or the oral contraceptive pill.
Danish: [Neurontin og ledsagende navne] påvirker ikke virkningen af anden medicin mod epilepsi eller oral svangerskabsforebyggende medicin.
English: Although there is no evidence of rebound seizures with gabapentin, abrupt withdrawal of anticonvulsants in epileptic patients may precipitate status epilepticus (see section 4.2).
Danish: Skønt der ikke er evidens for rebound anfald med gabapentin, kan pludselig ophør af antiepileptikabehandling hos patienter med epilepsi føre til status epilepticus (se pkt.
English: Gabapentin is present in the breast milk of breast-feeding women.
Danish: Gabapentin findes i modermælk hos ammende kvinder.
English: The precise mechanism of action of gabapentin is not known.
Danish: Gabapentins virkningsmekanisme er ikke kendt.
English: Elderly patients may require dosage adjustment because of declining renal function with age (see Table 2).
Danish: Dosisreduktion hos ældre kan være nødvendig på grund af nedsat nyrefunktion (se tabel 2).
English: DOSING CHART - INITIAL TITRATION
Danish: DOSERINGSPLAN - INITIALTITRERING
English: No interaction between gabapentin and phenobarbital, phenytoin, valproic acid, or carbamazepine has been observed.
Danish: Der er ikke set interaktion mellem gabapentin og phenobarbital, phenytoin, valproat eller carbamazepin.
English: As with other anti-epileptics, attempts to withdraw concomitant anti-epileptics in treatment refractory patients on more than one anti-epileptic, in order to reach gabapentin monotherapy have a low success rate.
Danish: Som for andre antiepileptika vil forsøg på seponering af andre samtidige antepileptika hos refraktære patienter, der behandles med mere end et antiepileptikum for at opnå gabapentin monoterapi, have en lav succesrate.
English: 300 mg two times a day 300 mg three times a day
Danish: 300 mg 1 gang dagligt 300 mg 2 gange dagligt
English: Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but its mechanism of action is different from that of several other active substances that interact with GABA synapses including valproate, barbiturates, benzodiazepines, GABA transaminase inhibitors, GABA uptake inhibitors, GABA agonists, and GABA prodrugs.
Danish: Gabapentin ligner strukturmæssigt neurotransmitteren GABA (gammaaminosmørsyre), men dets virkningsmekanisme er forskellig fra den mekanisme, som flere andre aktive stoffer interagerer med GABA-synapser på, herunder valproat, barbiturater, benzodiazepiner, GABA-transaminase-hæmmere, GABA-uptake-hæmmere, GABA-agonister og GABA-prodrugs.
English: The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600 mg/day is a total of 3 weeks.
Danish: Det tager mindst 1 uge at nå en dosis på 1800 mg dagligt, 2 uger at nå en dosis på 2400 mg dagligt, og i alt 3 uger at nå en dosis på 3600 mg dagligt.
English: Gabapentin pharmacokinetics are not affected by repeated administration.
Danish: Gabapentins farmakokinetik påvirkes ikke af gentagen indgift.
English: The total daily dose should be divided in three single doses, the maximum time interval between doses should not exceed 12 hours.
Danish: Den totale daglige dosis bør fordeles på 3 enkeltdoser, og der bør ikke gå mere end 12 timer mellem doserne.
English: 300 mg once a day
Danish: 300 mg 3 gange dagligt
English: Peripheral neuropathic pain: [Neurontin and associated names] is used to treat long lasting pain caused by damage to the nerves.
Danish: Perifere neurogene smerter: [Neurontin og ledsagende navne] anvendes til behandling af langvarige smerter, som skyldes beskadigede nervebaner.
English: Cmax (µg/ml) tmax (hr) T1/2 (hr) AUC (0-8) µg•hr/ml) Ae% (%)
Danish: AUC (0-8) µg•time/ml) 24,8 Ae% (%)
English: • Low white blood cell counts
Danish: • Lavt antal hvide blodlegemer
English: • Anger towards others, confusion, fluctuation in mood, depression, anxiety, nervousness, difficulty with thinking
Danish: • Vrede over for andre, forvirring, humørsvingninger, depression, angst, nervøsitet, vanskelighed ved at tænke
English: Alternatively, the starting dose is 900 mg/day given as three equally divided doses.
Danish: Alternativt anbefales en initialdosis på 900 mg dagligt fordelt på 3 lige store doser.
English: Gabapentin at relevant clinical concentrations does not bind to other common drug or neurotransmitter receptors of the brain including GABAA, GABAB, benzodiazepine, glutamate, glycine or N-methyl-daspartate receptors.
Danish: I klinisk relevante koncentrationer bindes gabapentin ikke til andre almindelige lægemidler eller neurotransmittere i hjernen, herunder receptorer for GABAA, GABAB, benzodiazepin, glutamat, glycin eller N-metyl-d-aspartat.
English: Gabapentin slightly reduces the release of monoamine neurotransmitters in vitro.
Danish: Gabapentin nedsætter svagt frigivelsen af monoamin-neurotransmittere in vitro.
English: • Inflammation of the liver, yellowing of the skin and eyes
Danish: • Leverbetændelse, gulfarvning af huden og øjnene
English: Therapy may be initiated by titrating the dose as described in Table 1 or by administering 300 mg three times a day (TID) on Day 1.
Danish: Behandlingen indledes med dosistitrering, som anført i tabel 1, eller en initialdosis på 300 mg 3 gange dagligt på dag 1.
English: In addition to the maintenance dose, an additional 200 to 300 mg dose following each 4-hour haemodialysis treatment is recommended.
Danish: I tillæg til vedligeholdelsesdosis anbefales en dosis på yderligere 200-300 mg efter hver 4 timers hæmodialyse.
English: It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy.
Danish: Det er ikke nødvendigt at monitorere plasmaniveauerne for at fastsætte den optimale gabapentinbehandling.
English: Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for two years.
Danish: Gabapentin blev givet gennem føden til mus i doser på 200, 600 og 2000 mg/kg/dag og til rotter i doser på 250, 1000 og 2000 mg/kg/dag i 2 år.
English: [Description to be completed nationally]
Danish: [Beskrivelse udfyldes nationalt]
English: • Incontinence
Danish: • Inkontinens
English: Reproductive system and breast disorders Common:
Danish: Lidelser i det reproduktive system og brystsygdomme Almindelig:
English: b To be administered as 300 mg every other day.
Danish: b Gives som 300 mg hver 2. dag.
English: Gabapentin, the active substance of [Neurontin and associated names], is excreted in human milk.
Danish: Gabapentin, der er det aktive stof i [Neurontin og ledsagende navne], bliver udskilt i modermælken.
English: Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects.
Danish: De hyppigst indberettede misdannelser er hareskår, kardiovaskulære misdannelser og neuralrørsdefekter.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig eller De bemærker bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
English: In the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia, efficacy and safety have not been examined in clinical studies for treatment periods longer than 5 months.
Danish: Behandling af perifere neurogene smerter, som f.eks. smertefuld diabetisk neuropati og postherpetisk neuropati, er ikke undersøgt i behandlingsperioder længere end 5 måneder i kliniske undersøgelser.
English: Dosages up to 50 mg/kg/day have been well tolerated in a longterm clinical study.
Danish: Doser på op til 50 mg/kg dagligt var veltålt i en åben langtidsundersøgelse.
English: In a teratology study in rabbits, an increased incidence of post-implantation fetal loss, occurred in doses given 60, 300, and 1500 mg/kg/day during organogenesis.
Danish: I et teratologiforsøg på kaniner ses en øget forekomst af aborter efter implantation ved doser på 60, 300 og 1500 mg/kg/dag under organogenesen.
English: hallucinations
Danish: hallucinationer
English: In animals, gabapentin readily enters the brain and prevents seizures from maximal electroshock, from chemical convulsants including inhibitors of GABA synthesis, and in genetic models of seizures.
Danish: Hos dyr trænger gabapentin uhindret ind i hjernen og modvirker krampeanfald fremkaldt af elektrochok, af kemiske konvulsiva, herunder GABA-syntese-hæmmere, samt i genetiske krampemodeller.
English: Impairment of Fertility
Danish: Forringelse af fertilitet
English: Somnolence, peripheral oedema and asthenia may be more frequent in elderly patients.
Danish: Søvnighed, perifere ødemer og asteni kan forekomme hyppigere hos ældre patienter.
English: − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: - Hvis en bivirkning bliver alvorlig, eller De bemærker bivirkninger, som ikke er nævnt i denne information, bør De fortælle det til Deres læge eller apotek.
English: An increased incidence of hydroureter and/or hydronephrosis was observed in rats given 2000 mg/kg/day in a fertility and general reproduction study, 1500 mg/kg/day in a teratology study, and 500, 1000, and 2000 mg/kg/day in a perinatal and postnatal study.
Danish: Øget forekomst af hydroureter og/eller hydronefrose ses hos rotter, der får 2000 mg/kg/dag i en fertilitetsundersøgelse og generel reproduktionsundersøgelse, 1500 mg/kg/dag i et teratologiforsøg og 500, 100 og 2000 mg/kg/dag i et perinatal- og postnatalforsøg.
English: Somnolence, peripheral oedema and asthenia may be more frequent in the elderly.
Danish: Somnolens, perifere ødemer og asteni kan være hyppigere hos ældre.
English: Do not suddenly discontinue taking this medicine as this may lead to breakthrough seizure, which could have serious consequences for you and your baby.
Danish: Antiepileptisk behandling bør ikke seponeres pludseligt, da dette kan føre til gennembrudsanfald, der kan få alvorlige konsekvenser for både moder og barn.
English: − if you develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately.
Danish: - hvis De har nyreproblemer - hvis De får vedvarende mavesmerter, får kvalme eller kaster op, skal De straks kontakte lægen.
English: hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal
Danish: fjendtlighed, konfusion og følelsesmæssig labilitet, depression, angst, nervøsitet, abnorm tankegang
English: hepatitis, jaundice
Danish: hepatitis, icterus
English: The most common undesirable effects observed in clinical trials consisted of somnolence, dizziness, ataxia, fatigue, fever and viral infection.
Danish: De hyppigste bivirkninger, der er observeret i de kliniske undersøgelser, er somnolens, svimmelhed, ataksi, træthed, feber og virusinfektioner.
English: There is no evidence of gabapentin metabolism in humans.
Danish: Der er ingen evidens for metabolisk omsætning hos mennesker.
English: The MAH confirmed the intention, in a letter of commitment, to submit across EU a paediatric liquid formulation in order to provide a dosage form more suitable for use in children.
Danish: Indehaveren af markedsføringstilladelsen påtog sig i en tilsagnserklæring at søge en oral væske til pædiatrisk brug godkendt i hele EU for at kunne levere en lægemiddelform, der er mere velegnet til børn.
English: 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] Capsules: 20, 30, 50, 84, 90, 98, 100, 200, 500, 1000 Tablets: 20, 30, 45, 50, 84, 90, 100, 200, 500
Danish: Kapsler: 20, 30, 50, 84, 90, 98, 100, 200, 500, 1000
English: For anuric patients undergoing haemodialysis who have never received gabapentin, a loading dose of 300 to 400 mg, then 200 to 300 mg of gabapentin following each 4 hours of haemodialysis, is recommended.
Danish: Anuripatienter, der er i hæmodialysebehandling, og som ikke tidligere har været i behandling med gabapentin, gives initialt en dosis på 300-400 mg gabapentin, derefter 200-300 mg gabapentin efter hver 4 timers hæmodialyse.
English: Finally, in children, aggressive behaviour and hyperkinesias were reported commonly.
Danish: Endelig blev aggressiv adfærd og hyperkinesi hyppigt iagttaget hos børn.
English: False positive readings may be obtained in the semi-quantitative determination of total urine protein by dipstick tests.
Danish: Der er rapporteret om falsk-positive resultater ved brug af indikatorpapir/teststrimler til semikvantitativ bestemmelse af proteinindholdet i urinen.
English: • Decreased platelets (blood clotting cells)
Danish: • Nedsat antal blodplader (får blodet til at størkne)
English: Under treatment with gabapentin cases of acute pancreatitis were reported.
Danish: Der er set tilfælde af akut pancreatitis under behandling med gabapentin.
English: Skin and subcutaneous tissue disorders Common:
Danish: Sygdomme i hud og subkutane væv Almindelig:
English: • Pneumonia, respiratory infection, urinary tract infection, infection, inflammation of the ear
Danish: • Lungebetændelse, luftvejsinfektion, urininfektion, infektion, betændelse i øret
English: Boulevard de la Plaine, 17 B-1050 Bruxelles Belgium
Danish: Boulevard de la Plaine, 17 B-1050 Bruxelles Belgien
English: The starting dose will generally be between 300 mg and 900 mg each day.
Danish: Startdosis er normalt 300-900 mg dagligt.
English: Peak plasma drug concentrations in rats at 2000 mg/kg/day are 10 times higher than plasma concentrations in humans given 3600 mg/day.
Danish: Hos rotter, der fik 2000 mg/kg/dag, var den maksimale plasmakoncentration 10 gange højere end plasmakoncentrationen hos mennesker, der fik 3600 mg/dag.
English: The pancreatic acinar cell tumors in male rats are low-grade malignancies, did not affect survival, did not metastasize or invade surrounding tissue, and were similar to those seen in concurrent controls.
Danish: Disse har ingen indflydelse på overlevelsestiden, metastaserer ikke, angriber ikke det omgivende væv og er sammenlignelig med tilsvarende tumorer, som er fundet hos kontrolgruppen.
English: No adverse effects on fertility or reproduction were observed in rats at doses up to 2000 mg/kg (approximately five times the maximum daily human dose on a mg/m2 of body surface area basis).
Danish: Der er ikke set påvirkning af fertilitet eller reproduktion hos rotter ved doser op til 2000 mg/kg (ca. 5 gange den maksimale daglige dosis til mennesker omregnet til mg/m2 på basis af kroppens overfladeareal).
English: These effects occurred when pregnant mice received oral doses of 1000 or 3000 mg/kg/day during organogenesis and in rats given 500, 1000, or 2000 mg/kg prior to and during mating and throughout gestation.
Danish: Disse virkninger ses, når drægtige mus bliver givet orale doser på 1000 eller 3000 mg/kg/dag under organogenesen og hos rotter, der får 500, 1000 eller 2000 mg/kg før og under parring samt i drægtighedsperioden.
English: facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne
Danish: ansigtsødem, purpura, oftest beskrevet som blå mærker, som skyldes et fysisk traume, udslæt, kløe, akne
English: incontinence
Danish: inkontinens
English: Causality with gabapentin is unclear (see section 4.4).
Danish: Årsagssammenhæng er uklar (se pkt.
English: • Severe skin reactions that require immediate medical attention, swelling of the lips and face, skin rash and redness, hair loss
Danish: • Alvorlige allergiske reaktioner, som straks kræver lægehjælp, opsvulming af læber og ansigt,
English: In vitro studies with radiolabeled gabapentin have characterized a novel peptide binding site in rat brain tissues including neocortex and hippocampus that may relate to anticonvulsant and analgesic activity of gabapentin and its structural derivatives.
Danish: In vitro forsøg med radioaktivt mærket gabapentin har karakteriseret et nyt peptid-bindingssted i rottehjernevæv, herunder neocortex og hippocampus, der kan relateres til den antikonvulsive og analgetiske virkning af gabapentin og dets strukturmæssige derivater. Gabapentins bindingssted er identificeret som alfa2 -delta underenhed af de spændingsafhængige calciumkanaler.
English: − The active substance is gabapentin.
Danish: Hvad [Neurontin og ledsagende navne] indeholder - Det aktive stof er gabapentin.
English: Stevens-Johnson syndrome, angioedema, erythema multiforme, alopecia Musculoskeletal, connective tissue and bone disorders Common:
Danish: Stevens-Johnsons syndrom, angioødem, erythema multiforme, alopeci
English: [Neurontin and associated names] should not be taken during pregnancy, unless you are told otherwise by your doctor.
Danish: De må ikke tage [Neurontin og ledsagende navne] under graviditet, medmindre lægen har fortalt Dem noget andet.
English: Very common side-effects which may affect more than 1 person in 10 are listed below:
Danish: Meget almindelige bivirkninger, det forekommer hos flere end 1 ud af 10 patienter, er nævnt nedenfor:
English: convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypaesthesia, coordination abnormal, nystagmus, increased, decreased, or absent reflexes
Danish: konvulsioner, hyperkinesi, dysartri, amnesi, tremor, søvnløshed, hovedpine, berøringsfølelse som f.eks. paræstesi, hypæstesi, koordinationsforstyrrelser, nystagmus, forstærkede, nedsatte eller fraværende reflekser
English: acute renal failure
Danish: akut nyresvigt
English: In addition, the MAH confirmed the intention, in a letter of commitment, to submit across EU a paediatric liquid formulation in order to provide a dosage form more suitable for use in children.
Danish: I en tilsagnserklæring påtog indehaveren af markedsføringstilladelsen sig derudover at søge en oral væske til pædiatrisk brug godkendt i hele EU for derved at kunne levere en lægemiddelform, der er mere velegnet til børn.
English: NAME OF THE MARKETING AUTHORISATION HOLDER {Name} [See Annex I - To be completed nationally]
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN {Navn} [Se bilag I - Udfyldes nationalt]
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG III PRODUKTRESUMÈ, ETIKETTERING og INDLÆGSSEDDEL
English: This is especially true at the beginning of the treatment and after increase in dose.
Danish: Der bør tages højde herfor, særligt i forbindelse med behandlingsstart eller ved dosisøgning.
English: Therefore, the MAH proposal of a harmonised wording was endorsed; as follows: “Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.”
Danish: Derfor er den ordlyd godkendt, som er foreslået af indehaveren af markedsføringstilladelsen: "Gabapentin er indiceret til behandling af perifere neuropatiske smerter såsom smertefuld diabetisk neuropati og post-herpetisk neuralgi hos voksne."
English: Cardiac disorders Rare:
Danish: Hjertesygdomme Sjælden:
English: This product contains lactose monohydrate.
Danish: Indeholder lactosemonohydrat.
English: However, in patients with severe renal impairment, haemodialysis may be indicated.
Danish: Hos patienter med svært nedsat nyrefunktion kan hæmodialyse dog være indiceret.
English: PFIZER HELLAS 243 Messoghion Ave., Neo Psychiko 154 51 Greece
Danish: PFIZER HELLAS 243 Messoghion Ave., Neo Psychiko 154 51 Grækenland
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {Name and Address} <{tel}> <{fax}> <{e-mail}> [See Annex I - To be completed nationally]
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN {Navn og adresse} <{tlf}> <{fax}> <{email}> [Se bilag I - Udfyldes nationalt]
English: Gabapentin is removed from plasma by haemodialysis.
Danish: Gabapentin fjernes fra plasma ved hæmodialyse.
English: It is therefore recommended that [Neurontin and associated names] is taken at the earliest two hours after taking an antacid.
Danish: Derfor bør disse midler tages mindst 2 timer før [Neurontin og ledsagende navne].
English: Mutagenesis
Danish: Mutagenicitet