FrancophonIA/ELRC3.0 huggingface dataset:
English: These cells are ‘characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins'.
Danish: Disse celler er »karakteriserede levedygtige autologe bruskceller opformeret ex vivo, som udtrykker specifikke markørproteiner«.
English: There was no clear evidence of a difference in the change of KOOS in patients treated with ChondroCelect and those treated with microfracture.
Danish: Der blev ikke klart påvist nogen forskel i ændringen af KOOS-scoren hos patienter behandlet med ChondroCelect og patienter behandlet med mikrofraktur.
English: ChondroCelect must not be used in people who are hypersensitive (allergic) to any of the other ingredients or to bovine serum (cow's blood).
Danish: ChondroCelect må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for andre af indholdsstofferne eller over for bovint serum (blod fra kvæg).
English: During surgery on the knee, the suspension is placed into the defect in the patient's cartilage.
Danish: Under det kirurgiske indgreb i knæet anbringes suspensionen i patientens bruskdefekt.
English: ChondroCelect is a suspension for implantation that contains cartilage cells.
Danish: ChondroCelect er en suspension til implantation, som indeholder bruskceller.
English: After one year, when scans were performed and samples of cartilage were examined, patients who were treated with ChondroCelect showed better structural repair of their cartilage than patients treated with microfracture.
Danish: Da der efter et år blev foretaget scanninger og undersøgt bruskprøver, sås der hos de patienter, som var behandlet med ChondroCelect, en bedre strukturel reparation af brusken end hos dem, der var behandlet med mikrofraktur.
English: ChondroCelect was also as effective as microfracture at improving symptoms.
Danish: ChondroCelect var desuden lige så effektivt som mikrofraktur til at forbedre symptomerne.
English: It is used when there is a single defect in the cartilage of the femoral condyle (the bottom end of the thighbone) that is causing symptoms.
Danish: Det anvendes, når en enkelt bruskdefekt i knæets femurkondyl (den nederste ende af lårbensknoglen) forårsager symptomer.
English: The KOOS was measured by patients rating the severity of their symptoms.
Danish: KOOS-scoren blev fastlagt på grundlag af patienternes egen vurdering af symptomernes sværhedsgrad.
English: This helps the patients to recover from the operation but also leaves enough time for the cartilage cells to implant themselves and for the knee to heal.
Danish: Det hjælper patienten til at komme sig efter operationen, men giver også bruskcellerne den nødvendige tid til, at de kan implantere sig og knæet kan heles.
English: The most common side effects with ChondroCelect (seen in more than 1 patient in 10) are arthralgia (joint pain), cartilage hypertrophy (overgrowth), joint crepitation (unusual crackling sounds) and swelling of the joint.
Danish: De hyppigste bivirkninger ved ChondroCelect (som optræder hos flere end 1 ud af 10 patienter) er ledsmerter, bruskovervækst (hypertrofi), ledkrepitation (usædvanlige knirkelyde) og hævelse i leddet.
English: The company is also performing an observational study to obtain more information about the safety and effectiveness of ChondroCelect.
Danish: Virksomheden foretager desuden en observationsundersøgelse af ChondroCelect med henblik på at fremskaffe oplysninger om dets sikkerhed og virkning.
English: This means that they are cells taken from the patient, grown outside the body and can be used for implantation into the patient's cartilage.
Danish: Det betyder, at cellerne udtages fra patienten og dyrkes eksternt, hvorefter de kan implanteres i patientens brusk.
English: The cartilage cells are then grown and expanded in the laboratory to provide enough cells to make up a suspension of cells that can be used to treat the cartilage defect.
Danish: Herefter dyrkes bruskcellerne i laboratoriet, så der opformeres tilstrækkelig mange celler til at danne en cellesuspension, som kan anvendes til behandling af bruskdefekten.
English: What is the risk associated with ChondroCelect?
Danish: Hvilken risiko er der forbundet med ChondroCelect?
English: It must also not be used in patients with advanced osteoarthritis of the knee (a disease causing swelling and pain in the knee) and those with the femoral growth plate (the end part of the thighbone) that is not fully closed.
Danish: Det må heller ikke anvendes hos patienter med fremskreden slidgigt i knæet (en lidelse, som forårsager hævelse og smerte i knæet) eller patienter, hvor epifyseskiven i lårbenet (endedelen af lårbenet) ikke er fuldstændig lukket.
English: ChondoCelect is a type of advanced therapy medicine called a ‘tissue engineered product'.
Danish: ChondroCelect er et lægemiddel til avanceret terapi, som kaldes et »produkt fremstillet ved vævsteknik«.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ChondroCelect, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for ChondroCelect, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The training materials for surgeons will include information on how to collect the cartilage biopsy from patients, perform the operation and follow patients up.
Danish: Undervisningsmaterialerne for kirurger omfatter information om, hvordan man tager bruskbiopsien hos patienterne, udfører operationen og følger op på patienterne.
English: ChondroCelect is used in adults to repair damage to the cartilage in the knee.
Danish: ChondroCelect anvendes til reparation af bruskskader i knæet hos voksne.
English: ChondroCelect characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Danish: ChondroCelect karakteriserede levedygtige autologe bruskceller opformeret ex vivo, som udtrykker specifikke markørproteiner
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ChondroCelect.
Danish: Det forklarer, hvordan agenturet vurderede lægemidlet for at kunne anbefale udstedelse af en markedsføringstilladelse i EU og fastlægge anvendelsesbetingelserne.
English: The materials for other healthcare professionals will include information on how to handle the collected biopsy and prepare ChondroCelect for implantation, and how to follow patients up and plan the recommended physiotherapy.
Danish: Undervisningsmaterialerne for det resterende sundhedspersonale omfatter information om, hvordan man håndterer den udtagne biopsi og forbereder ChondroCelect til implantationen, følger op på patienterne og planlægger den anbefalede fysioterapi.
English: For the full list of all side effects reported with ChondroCelect, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved ChondroCelect fremgår af indlægssedlen.
English: ChondroCelect was more effective than microfracture at healing the defects in the cartilage.
Danish: ChondroCelect var mere effektivt end mikrofraktur til at få bruskdefekterne til at hele.
English: Why has ChondroCelect been approved?
Danish: Hvorfor blev ChondroCelect godkendt?
English: How has ChondroCelect been studied?
Danish: Hvordan blev ChondroCelect undersøgt?
English: What is ChondroCelect?
Danish: Hvad er ChondroCelect?
English: What benefit has ChondroCelect shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ChondroCelect?
English: What is ChondroCelect used for?
Danish: Hvad anvendes ChondroCelect til?
English: How is ChondroCelect used?
Danish: Hvordan anvendes ChondroCelect?
English: Based on the assessment performed by the CAT, the CHMP decided that ChondroCelect's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: ChondroCelect opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for ChondroCelect.
English: How does ChondroCelect work?
Danish: Hvordan virker ChondroCelect?
English: You may need to read it again.
Danish: De får måske brug for at læse den igen.
English: Taking [Neurontin and associated names] with food and drink [Neurontin and associated names] can be taken with or without food.
Danish: Hvordan man tager [Neurontin og ledsagende navne] sammen med mad og drikkevarer [Neurontin og ledsagende navne] kan tages sammen med mad eller uden mad.
English: If you are an elderly patient (over 65 years of age), you should take [Neurontin and associated names] normally except if you have problems with your kidneys.
Danish: Hvis De holder op med at tage [Neurontin og ledsagende navne] De må ikke stoppe med at tage [Neurontin og ledsagende navne], medmindre Deres læge har bedt Dem herom.
English: No significant issues were identified during the procedure.
Danish: Der blev ikke fundet nogen væsentlige spørgsmål under proceduren.
English: Linearity/Non-linearity
Danish: Linearitet / non-linearitet:
English: All divergent opinions have been resolved.
Danish: Alle divergenser er hermed bragt til ophør.
English: The significance of these findings is unknown, but they have been associated with delayed development.
Danish: Betydningen af disse fund kendes ikke, men de er forbundet med forsinket udvikling.
English: NA NA 47.2
Danish: NA 47,2
English: Response (≥ 50% Improved) by Treatment and Age MITT* Population Age Category
Danish: Respons (≥ 50% forbedring) ved behandling og alder MITT* population Alder
English: The data from this additional post-hoc analysis are summarised in the table below:
Danish: Data fra denne ekstra post-hoc analyse er opsummeret i tabellen nedenfor:
English: All patients recovered fully with supportive care.
Danish: Alle patienter er fuldt restituerede efter understøttende behandling.
English: Use in elderly patients (over 65 years of age)
Danish: Ældre (over 65 år)
English: Benefit/Risk considerations
Danish: Risk/benefit-hensyn
English: Adults and adolescents:
Danish: Voksne og unge:
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:
English: Take as directed by the doctor.
Danish: Følg lægens anvisning.
English: Do not take a double dose to make up for a forgotten dose.
Danish: De må ikke tage dobbelt dosis, som erstatning for en glemt dosis.
English: Your doctor will determine what dose is appropriate for you.
Danish: Deres læge vil fastsætte, hvilken dosis, der passer til Dem.
English: You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
Danish: De bør ikke køre bil, betjene indviklede maskiner eller foretage andre mulige farlige aktiviteter, før De ved, hvordan denne medicin påvirker Deres evne til at udføre disse aktiviteter.
English: Total Daily Dosea (mg/day)
Danish: Total daglig dosisa (mg/dag)
English: Via Valbondione, 113 00188 Roma
Danish: Via Valbondione, 113 00188 Rom
English: Children aged 6 years and above:
Danish: Børn på 6 år og derover:
English: The CHMP agreed that the indication should not be restricted to patients refractory to standard medication.
Danish: CHMP var enig i, at indikationen ikke bør begrænses til patienter, der er refraktære over for standardbehandling.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NEURONTIN AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF NEURONTINOG TILKNYTTEDE NAVNE (se bilag I)
English: Risk related to gabapentin
Danish: Risiko relateret til gabapentin
English: Epilepsy typically requires long-term therapy.
Danish: Epilepsi kræver sædvanligvis langtidsbehandling.
English: Do not pass it on to others.
Danish: Giv derfor ikke medicinen til andre.
English: The benefits of prolonged therapy must therefore be weighed against the potential risks of such therapy.
Danish: Fordelen af forlænget behandling skal derfor opvejes mod den mulige risiko ved en sådan behandling.
English: Dubravska cesta 2, 841 04 Bratislava, Slovak Republic
Danish: Dubravska cesta 2, 841 04 Bratislava, Slovakiet
English: • Non-clinical issues
Danish: • Ikke-kliniske spørgsmål
English: Gabapentin may have minor or moderate influence on the ability to drive and use machines.
Danish: Gabapentin har mindre eller moderat indflydelse på evnen til at føre bil eller betjene maskiner.
English: No significant issues relating to quality were identified and the pharmaceutical particulars of the product information were completed, except for the sections to be completed nationally.
Danish: Der blev ikke fundet væsentlige spørgsmål vedrørende kvalitet, og de farmaceutiske oplysninger i produktresuméet blev færdigudarbejdet bortset fra de afsnit, der skal udarbejdes nationalt.
English: Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section.
Danish: Doseringsvejledning for børn under 12 år er anført i særskilt underafsnit senere i pkt.
English: Take along any capsules or tablets that are left, the container and the label so that the hospital can easily tell what medicine you have taken.
Danish: Tag de kapsler eller tabletter, som er tilbage, beholderen og etiketten med, så hospitalet let kan se, hvilken medicin De har taget.
English: Pfizer Healthcare Ireland 9 Riverwalk,
Danish: Pfizer Healthcare Irland 9 Riverwalk,
English: Therefore, patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentin or morphine should be reduced appropriately.
Danish: Derfor bør disse patienter omhyggeligt observeres for tegn på CNS depression, som f.eks. søvnighed, og dosis af gabapentin eller morfin bør reduceres på passende vis.
English: Pharmacokinetic parameters are given in Table 3.
Danish: Farmakokinetiske parametre er anført i Tabel 3.
English: Dosage is determined by the treating physician according to individual tolerance and efficacy.
Danish: Dosis fastsættes af den behandlende læge i henhold til individuel tolerans og effekt.
English: • Ringing in the ears
Danish: • Ringen for ørerne
English: Gabapentin demonstrated no genotoxic potential.
Danish: Gabapentin viser ikke genotoksisk potentiale.
English: Cmax = Maximum steady state plasma concentration tmax = Time for Cmax
Danish: Cmax = Maksimalt steady state plasmakoncentration tmax = Tid for Cmax
English: Even, if they were only of mild or moderate degree, these undesirable effects could be potentially dangerous in patients driving or operating machinery.
Danish: Selv, hvis disse kun er milde eller moderate, kan disse bivirkninger potentielt være farlig for patienter, der fører bil eller betjener maskiner.
English: Like all medicines, [Neurontin and associated names] can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan [Neurontin og ledsagende navne] give bivirkninger, selvom ikke alle får bivirkninger.
English: It is therefore recommended to verify such a positive dipstick test result by methods based on a different analytical principle such as the Biuret method, turbidimetric or dye-binding methods, or to use these alternative methods from the beginning.
Danish: Det anbefales at verificere et sådant testresultat ved at anvende metoder, der er baseret på et andet analytisk princip som f.eks. Biuret-metoden, turbidimetri eller farvestofbindingsmetoder eller at anvende disse alternative metoder fra starten.
English: Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking [Neurontin and associated names].
Danish: Kontakt straks lægen, hvis De bliver gravid, hvis De har en formodning om, at De er gravid, eller ønsker at blive gravid, mens De tager [Neurontin og ledsagende navne].
English: *The modified intent to treat population was defined as all patients randomised to study medication who also had evaluable seizure diaries available for 28 days during both the baseline and double-blind phases.
Danish: *Den modificerede ”intent to treat” population er defineret som alle patienter, der er randomiseret til forsøgsmedicin, og som også har evaluerbar dagbog over anfald tilgængelig i alle 28 dage under både baseline og dobbelt-blind faserne.
English: The absence of adequate long term studies (more than 36 weeks) in children to assess growth, learning, intelligence, and development in children and adolescents, is mentioned in section 4.4.
Danish: Fraværet af langtidsundersøgelser (over 36 uger) til vurdering af vækst, indlæring, intelligens og udvikling hos børn og unge er nævnt i afsnit 4.4.
English: Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
Danish: Deres læge kan have anvist en anden doseringsvejledning og/eller dosis, hvis De har nyreproblemer.
English: Gabapentin is not bound to plasma proteins and has a volume of distribution equal to 57.7 litres.
Danish: Gabapentin bindes ikke til plasmaproteiner, og har et fordelingsvolumen på 57,7 liter.
English: The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days.
Danish: Behandlingen vil starte med en lav startdosis, som gradvist vil blive øget over en periode på cirka 3 dage.
English: Based on the available information and a literature search, no major safety issue seems to be associated with the administration of gabapentin.
Danish: Ud fra de foreliggende oplysninger og en litteratursøgning synes der ikke at være knyttet større sikkerhedsproblemer til administration af gabapentin.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: De bør kontakte Deres læge eller apotek, hvis De er usikker.
English: Contact address:
Danish: Kontaktadresse:
English: Apart from these findings, clinical investigations in this age group do not indicate an adverse event profile different from that observed in younger patients.
Danish: Bortset fra disse fund, tyder kliniske undersøgelse hos denne aldersgruppe ikke på en bivirkningsprofil, der er forskellig fra den, der er set hos yngre patienter.
English: Do not use [Neurontin and associated names] after the expiry date which is stated on the carton after [to be completed nationally].
Danish: Anvend ikke [Neurontin og ledsagende navne] efter udløbsdatoen, som står på kartonen efter {udfyldes nationalt}.
English: It is not possible to differentiate if the developmental delay is caused by genetic, social factors, maternal epilepsy or the antiepileptic therapy.
Danish: Det er ikke muligt at skelne, om forsinket psykisk udvikling skyldes genetiske eller sociale faktorer, maternal epilepsi eller den antiepileptiske behandling.
English: Absolute bioavailability of a 300 mg capsule is approximately 60%.
Danish: Absolut biotilgængelighed af en 300 mg kapsel er ca. 60%.
English: If you forget to take [Neurontin and associated names] If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.
Danish: Hvis De glemmer at tage [Neurontin og ledsagende navne] Hvis De glemmer at tage en dosis, skal De tage den straks, De kommer i tanke det, hvis ikke det er tid for næste dosis.
English: Gabapentin can be given with or without food and should be swallowed whole with sufficient fluidintake (e.g. a glass of water).
Danish: Gabapentin kan indtages med eller uden føde, og skal synkes hele med tilstrækkelig med væske (f.eks. 1 glas vand).
English: Therefore, whenever possible and only under the advice of your doctor, you should try to take only one seizure medication during pregnancy.
Danish: Derfor skal De, så snart det er muligt og kun efter aftale med lægen, kun tage et middel mod kramper under graviditet.
English: If a patient requires dosing longer than 5 months for the treatment of peripheral neuropathic pain, the treating physician should assess the patient's clinical status and determine the need for additional therapy.
Danish: Hvis en patient kræver en længere behandling end 5 måneder for behandling af perifere neurogene smerter, bør den behandlende læge vurdere patientens kliniske status og fastsætte behovet for yderligere behandling.
English: If you have the impression that the effect of [Neurontin and associated names] is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis De har indtryk af, at virkningen af [Neurontin og ledsagende navne] er for stærk eller alt for svag, skal De tale med Deres læge eller apotek.
English: T1/2 = Elimination half-life
Danish: T1/2 = Eliminationshalveringstid
English: Epilepsy: [Neurontin and associated names] is used to treat various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not).
Danish: Epilepsi: [Neurontin og ledsagende navne] anvendes til behandling af visse former for epilepsi (kramper, der i starten er begrænset til visse dele af hjernen, hvad enten kramperne spreder sig til andre dele af hjernen eller ej).
English: It is recommended that gabapentin be taken at the earliest two hours following antacid administration.
Danish: Det anbefales, at gabapentin indtages ca. 2 timer efter administration af antacida.
English: Risk related to epilepsy and antiepileptic medicinal products in general
Danish: Generel risiko relateret til epilepsi og antiepileptika
English: Table 3 Summary of gabapentin mean (%CV) steady-state pharmacokinetic parameters following every eight hours administration
Danish: Tabel 3 Resumé af gennemsnitlig gabapentin (%CV) steady state farmakokinetiske parametre efter administration hver 8. time
English: Instruction for all areas of indication
Danish: Vejledning for alle indikationer
English: Although plasma gabapentin concentrations were generally between 2 µg/ml and 20 µg/ml in clinical studies, such concentrations were not predictive of safety or efficacy.
Danish: Selvom gabapentins plasmakoncentration i kliniske undersøgelser generelt var 2-20 µg/ml, er disse koncentrationer ikke prædikative for sikkerhed eller effekt.
English: Sudden unexplained deaths have been reported where a causal relationship to treatment with gabapentin has not been established.
Danish: Der er set pludselig uforklarlig død, hvor årsagssammenhæng til behandling med gabapentin ikke er fastlagt.
English: In patients with poor general health, i.e., low body weight, after organ transplantation etc., the dose should be titrated more slowly, either by using smaller dosage strengths or longer intervals between dosage increases.
Danish: Hos patienter med generelt dårlig helbredstilstand, f.eks. med lav legemsvægt, efter organtransplantation eller lignende, bør dosistitrering ske langsommere enten ved at anvende en lavere styrke eller længere interval mellem dosisøgningerne.
English: [Neurontin and associated names] can also be used on its own to treat adults and children over 12 years of age.
Danish: [Neurontin og ledsagende navne] kan også bruges alene til at behandle voksne og børn over 12 år.
English: − This medicine has been prescribed for you.
Danish: - Lægen har ordineret denne medicin til Dem personligt.
English: Therefore, gabapentin should be used with caution in patients with mixed seizures including absences.
Danish: Derfor bør gabapentin anvendes med forsigtighed hos patienter med blandede anfaldslidelser, hvori der indgår absencer.
English: Gabapentin is not considered effective against primary generalized seizures such as absences and may aggravate these seizures in some patients.
Danish: Gabapentin betragtes ikke som effektivt i behandlingen af generaliserede anfald som f.eks. absencer og kan forværre disse anfald hos nogle patienter.
English: PHARMACEUTICAL FORM AND CONTENTS XX capsules or XX tablets [To be completed nationally]
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) XX kapsler eller XX tabletter [Udfyldes nationalt]