FrancophonIA/ELRC3.0 huggingface dataset:
English: Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain 5616 .................................................................................................................................. ≥ 1 RPU*
Danish: Lipoteichoinsyre (LTA) fra biofilmadhæsionskomponent (BAC) fra Streptococcus uberis, stamme 5616 .......................................................................................................................................... ≥ 1 RPU*
English: 17170- AMER (Girona) SPAIN
Danish: 17170- Amer (Girona) SPANIEN
English: Cardboard box with 20 glass vials of 1 dose (2 ml).
Danish: Kartonæske med 20 hætteglas (glas) a 1 dosis (2 ml).
English: Montanide ISA ............................................................................................................................907.1 mg
Danish: Montanid ISA ..............................................................................................................................907,1 mg
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr)
English: Monophosphoryl Lipid A (MPLA) Disodium phosphate dodecahydrate Potassium dihydrogen phosphate
Danish: Dinatriumphosphatdodecahydrat Kaliumdihydrogenphosphat Natriumchlorid
English: Vial label 1 dose and 5 doses
Danish: Etiket på hætteglas a 1 og 5 doser.
English: Cardboard box with 1 PET vial of 25 doses (50 ml).
Danish: Kartonæske med 1 hætteglas (PET) a 25 doser (50 ml).
English: Cardboard box with 1 PET vial of 50 doses (100 ml).
Danish: Kartonæske med 1 hætteglas (PET) a 50 doser (100 ml).
English: Cardboard box with 1 PET vial of 5 doses (10 ml).
Danish: Kartonæske med 1 hætteglas (PET) a 5 doser (10 ml).
English: Special warnings for each target species: Only healthy animals should be immunised.
Danish: Kun raske dyr bør immuniseres.
English: Avda.
Danish: UDL.D.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants in the member states
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), ansøger(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne
English: DICLOFENAC ALTERGON 50 MG TABLETY
Danish: DICLOFENAC ALTERGON 50 MG TABLETY 50 mg Tablet
English: (Invented) name Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: After first opening: 7 months
Danish: Efter første åbning: 7 måneder.
English: You may take Keppra with or without food.
Danish: De kan tage Keppra med eller uden mad.
English: Ensure it is well fixed.
Danish: Sørg for, at den sidder godt fast.
English: Abnormal and aggressive behaviours
Danish: Unormal og aggressiv adfærd
English: If such behaviours are noticed, treatment adaptation or gradual discontinuation should be considered.
Danish: Hvis sådan adfærd bemærkes, bør justering eller gradvis seponering af behandlingen overvejes.
English: • Drink the whole contents of the glass/baby's bottle.
Danish: • Drik hele glassets/sutteflaskens indhold.
English: • Close the bottle with the plastic screw cap.
Danish: • Luk flasken med plastikskruelåget.
English: Do not use after 7 months of first opening the bottle.
Danish: Skal anvendes inden for 7 måneder efter første åbning af flasken.
English: A doctor or a nurse will administer you Keppra as an intravenous infusion.
Danish: En læge eller en sygeplejerske vil give Dem Keppra som intravenøs infusion.
English: Keppra is used:
Danish: Keppra anvendes:
English: • Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
Danish: • Unormale tanker, følelse af irritation eller mere aggressive reaktioner end normalt, eller hvis De eller Deres familie og venner bemærker væsentlige humør- eller adfærdsændringer hos Dem.
English: Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m
Danish: Derfor anbefales en reduktion på 50 % af den daglige vedligeholdelsesdosis, når kreatininclearance er <60 ml/min/1,73 m2.
English: Therefore, the interaction of Keppra with other substances, or vice versa, is unlikely.
Danish: Derfor er interaktion mellem Keppra og andre lægemidler eller vice versa ikke sandsynlig.
English: As with all antiepileptic medicines, sudden discontinuation of levetiracetam should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Danish: Som med alle typer antiepileptikum bør pludselig seponering af levetiracetam undgås, da dette kan medføre gennembrudsanfald, der vil kunne få alvorlige følger for både kvinden og det ufødte barn.
English: Your doctor will prescribe the most appropriate pharmaceutical form of Keppra according to the age, weight and dose.
Danish: Deres læge vil ordinere den mest hensigtsmæssige lægemiddelform af Keppra afhængigt af alder, vægt og dosis.
English: Ю СИ БИ България ЕООД Teл.
Danish: България ЕООД Teл.
English: Only limited evidence is available on the neurodevelopment of children exposed to Keppra monotherapy in utero.
Danish: Der findes kun begrænset evidens på neuroudvikling hos børn udsat for Keppra monoterapi in utero.
English: • A small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin, som for eksempel Keppra, har haft selvmordstanker eller tanker om at gøre skade på sig selv.
English: Keppra therapy can be initiated with either intravenous or oral administration.
Danish: Behandling med Keppra kan indledes med enten intravenøs eller oral administration.
English: Date of first authorisation: 29 September 2000 Date of latest renewal: 20 August 2015
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 29. september 2000 Dato for seneste fornyelse: 20. august 2015
English: Preparation and administration of Keppra concentrate
Danish: Fremstilling og administration af Keppra-koncentrat
English: It was concluded that Keppra was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population.
Danish: Det blev konkluderet, at Keppra ikke adskilte sig (non-inferiort) fra placebo hvad angår ændring i forhold til baseline i score opnået i ”Leiter-R Attention and Memory, Memory Screen Composite"-testen i per protokol-populationen.
English: NextPharma SAS, 17 Route de Meulan, F-78520 Limay, France.
Danish: NextPharma SAS, 17 Route de Meulan, F-78520 Limay, Frankrig.
English: • Keppra is used as a chronic treatment.
Danish: • Keppra anvendes til kronisk behandling.
English: Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:
Danish: Fortæl altid lægen eller apotekspersonalet, hvis en af følgende bivirkninger bliver alvorlig eller varer længere end et par dage:
English: For doctors and nurses, more detailed direction for the proper use of Keppra is provided in section 6.
Danish: For læger og sygeplejersker er der angivet mere detaljerede retningslinjer for korrekt anvendelse af Keppra i punkt 6.
English: • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Danish: • Hvis De er allergisk over for levetiracetam, pyrrolidonderivater eller et af de øvrige indholdsstoffer i Keppra (angivet i punkt 6).
English: Levetiracetam may cause psychotic symptoms and behavioural abnormalities including irritability and aggressiveness.
Danish: Levetiracetam kan forårsage psykotiske symptomer og unormal adfærd, inklusive irritabilitet og aggressivitet.
English: Since there was limited exposure for Keppra intravenous use and since oral and intravenous formulations are bioequivalent, the safety information of Keppra intravenous will rely on Keppra oral use.
Danish: Da der var begrænset eksponering for intravenøst administreret Keppra og da de orale formuleringer og den intravenøse formulering er bioækvivalente, beror sikkerhedsinformationen for intravenøst Keppra på Keppra oral anvendelse.
English: • Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B).
Danish: • Fyld sprøjten med en smule opløsning ved at trække stemplet ned (figur 5A), tryk derefter stemplet opad for at fjerne eventuelle luftbobler (figur 5B).
English: These data are supplemented with the use of levetiracetam in corresponding openlabel extension studies, as well as post-marketing experience.
Danish: Disse data er suppleret med data fra brug af levetiracetam i tilsvarende åbne forlængede studier og erfaringer efter markedsføring.
English: After measuring the correct dosage with an appropriate syringe, Keppra oral solution may be diluted in a glass of water or baby's bottle.
Danish: Efter udtag af den korrekte dosis med en passende sprøjte kan Keppra oral opløsning fortyndes i et glas vand eller en sutteflaske.
English: Keppra concentrate is an alternative for patients when oral administration is temporarily not feasible.
Danish: Keppra-koncentrat er et alternativ til patienter, når oral administration midlertidigt ikke er mulig.
English: In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and βcarbolines.
Danish: Desuden ophæver det delvist reduktionen i GABA- og glycin -medierede strømme, induceret af zink og βcarboliner.
English: • Empty the contents of the syringe in a glass of water or baby's bottle by pushing the piston to the bottom of the syringe (figure 7).
Danish: • Tøm sprøjtens indhold ud i et glas vand eller en sutteflaske ved at trykke stemplet helt ned til sprøjtens bund (figur 7).
English: Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Danish: Keppra skal tages to gange dagligt, én gang om morgenen og én gang om aftenen, på omtrent samme tidspunkt hver dag.
English: Store in the original bottle in order to protect from light.
Danish: Opbevares i den originale flaske for at beskytte mod lys.
English: Prevalence is significantly higher in Japanese patients when compared to nonJapanese patients.
Danish: Forekomsten er betydeligt højere hos patienter af japansk afstamning i forhold til patienter af ikke-japansk afstamning
English: Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).
Danish: Træk stemplet ned til den måleangivelse, som svarer til det antal milliliter (ml), lægen har ordineret (figur 5C).
English: The following information is intended for healthcare professionals only: Directions for the proper use of Keppra is provided in section 3.
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Retningslinjer for korrekt anvendelse af Keppra er beskrevet i punkt 3.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Danish: Bivirkningerne er præsenteret i rækkefølge efter faldende alvorlighed, og deres hyppighed er defineret på følgende måde: meget almindelig (≥1/10); almindelig (≥ 1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De eller deres barn begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: • Wash the syringe with water only (figure 8).
Danish: • Vask sprøjten; brug kun vand (figur 8).
English: Keppra tablets are packaged in blister packs supplied in cardboard boxes containing:
Danish: Keppra tabletter er pakket i blisterpakninger og udleveres i papæsker indeholdende:
English: • Take the syringe and put it in the adaptor opening (figure 4).
Danish: • Tag sprøjten og placer den i adapteråbningen (figur 4).
English: Date of opening only for the outer carton
Danish: Dato for første åbning kun for den ydre emballage
English: All other packs are available in standard aluminium/PVC blisters.
Danish: Alle andre pakninger fås med standard aluminium/PVC-blisterkort.
English: Keppra is for intravenous use.
Danish: Keppra er til intravenøs anvendelse.
English: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Keppra overdoses.
Danish: Døsighed, agitation, aggression, nedsat bevidsthedsniveau, repirationshæmning og koma blev set ved overdosering med Keppra.
English: Keppra must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Danish: Keppra skal indgives to gange dagligt, én gang om morgenen og én gang om aftenen, på omtrent samme tidspunkt hver dag.
English: 500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 250 to 500 mg twice daily 500 to 1,000 mg once daily
Danish: 500 til 1.500 mg to gange dagligt 500 til 1.000 mg to gange dagligt 250 til 750 mg to gange dagligt 250 til 500 mg to gange dagligt 500 til 1.000 mg en gang dagligt (2)
English: Patients treated with levetiracetam should be monitored for developing psychiatric signs suggesting important mood and/or personality changes.
Danish: Patienter, der behandles med levetiracetam, bør overvåges for udvikling af psykiatriske tegn, der tyder på væsentlige humør- og/eller personlighedsændringer.
English: The starting dose for a child or adolescent of 25kg should be 250mg twice daily with a maximum dose of 750mg twice daily.
Danish: Den initiale dosis for et barn eller en ung på 25 kg bør være 250 mg to gange dagligt med en maksimal dosis på 750 mg to gange dagligt.
English: Monotherapy should be preferred whenever possible because therapy with multiple antiepileptic medicines AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.
Danish: Hvis det er muligt så foretrækkes monoterapi, da behandling med flere antiepileptika (AED'er) kunne være forbundet med højere risiko for medfødte misdannelser end behandling med monoterapi, afhængigt af de pågældende antiepileptika.
English: • Turn the bottle the right way up (figure 6A).
Danish: • Vend flasken, så den igen vender rigtigt opad (figur 6A).
English: If stopping treatment, Keppra should be discontinued gradually to avoid an increase of seizures.
Danish: Ved ophør af behandling skal Keppra nedtrappes gradvist for at undgå en forøgelse af anfald.
English: In most subjects with severe hepatic impairment, the clearance of levetiracetam was reduced by more than 50 % due to a concomitant renal impairment (see section
Danish: Hos de fleste personer med svært nedsat leverfunktion var levetiracetamclearance nedsat med mere end 50 % på grund af samtidig nyrefunktionsnedsættelse (se pkt.
English: Contact your doctor if you took more Keppra than you should.
Danish: Kontakt lægen, hvis De har taget mere Keppra, end De skal.
English: Swallow Keppra tablets with a sufficient quantity of liquid (e.g. a glass of water).
Danish: Keppra tabletter synkes med rigelig væske (f.eks. et glas vand).
English: Remove the syringe from the adaptor (figure 6B).
Danish: Fjern sprøjten fra adapteren (figur 6B).
English: Aesica Pharmaceuticals S.r.l., Via Praglia, 15, I-10044 Pianezza, Italy.
Danish: Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza, Italien.
English: However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behaviour were not worse than baseline.
Danish: Deltagere, som fik levetiracetam i det langvarige, åbneopfølgningsstudie, oplevede imidlertid generelt ikke nogen forværring af deres adfærds- og følelsesmæssige funktion; navnlig var graden af aggressiv adfærd ikke forværret i forhold til baseline.
English: Keppra 100 mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50kg and when tablets don't allow accurate dosage.
Danish: Keppra 100 mg/ml oral opløsning er den bedst egnede lægemiddelformulering til spædbørn og børn under 6 år og til børn og unge (fra 6 til 17 år), som vejer mindre end 50 kg, og hvor tabletter ikke muliggøre nøjagtig dosis.
English: Duration of treatment There is no experience with administration of intravenous levetiracetam for longer period than 4 days.
Danish: Behandlingsvarighed Der er ingen erfaring med intravenøs indgivelse af levetiracetam i mere end 4 dage.
English: The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50 % reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Danish: Det primære mål for effektivitet var responsraten (procent af patienter med ≥ 50 % reduktion i frekvensen af daglige partielle anfald i forhold til baseline) vurderet af en centralt blindet læser ved brug af 48 timers video -EEG.
English: Do not take Keppra
Danish: Tag ikke Keppra
English: Insert the adaptor into the bottle neck (figure 3).
Danish: Indsæt adapteren i flaskehalsen (figur 3).
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins ( 10 %).
Danish: Hverken levetiracetam eller den primære metabolit bindes i signifikant grad til plasmaproteiner
English: It also contains maltitol liquid; patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Danish: Det indeholder også flydende maltitol og bør derfor ikke anvendes til patienter med arvelig fructoseintolerans.
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of -ethyl-2-oxo-1pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Danish: Det aktive stof, levetiracetam er et pyrrolidon derivat (S-enantiomer af -ethyl-2-oxo-1-pyrrolidin acetamid), og er kemisk set ikke beslægtet med kendte antiepileptisk aktive stoffer.
English: Keppra may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Danish: Keppra kan påvirke Deres evne til at køre bil, motorcykel, cykle eller betjene værktøj og maskiner, da det kan give døsighed.
English: Keppra oral solution is the preferred formulation for use in this population.
Danish: Keppra oral opløsning bør foretrækkes til denne population.
English: Should your doctor decide to stop your Keppra treatment, he/she will instruct you about the gradual withdrawal of Keppra.
Danish: Hvis lægen beslutter at stoppe Deres behandling med Keppra, vil han/hun instruere Dem i, hvordan De gradvist skal ophøre med at tage Keppra.
English: Keppra contains sodium
Danish: Keppra indeholder natrium
English: In a pooled analysis, the percentage of patients who achieved 50% or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7 %, 31.6 % and 41.3 % for patients on 1000, 2000 or 3000 mg levetiracetam respectively and of 12.6 % for patients on placebo.
Danish: I en sammenfattende analyse var den procentdel af patienterne, som opnåede 50 % eller større reduktion fra baseline i frekvensen af partielle anfald pr. uge ved stabil dosis (12/14 uger), 27,7 %, 31,6 % og 41,3 % for patienter, som fik hhv. 1.000, 2.000 eller 3.000 mg levetiracetam, og 12,6 % for patienter, som fik placebo.
English: Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.
Danish: Udtag den korrekte dosis ved at anvende den 10 ml sprøjte, som er vedlagt i pakningen, og som er beregnet til patienter fra 4 år og opefter.
English: Keppra 250 mg film-coated tablets Keppra 500 mg film-coated tablets Keppra 750 mg film-coated tablets Keppra 1000 mg film-coated tablets
Danish: Keppra 250 mg filmovertrukne tabletter Keppra 500 mg filmovertrukne tabletter Keppra 750 mg filmovertrukne tabletter Keppra 1.000 mg filmovertrukne tabletter
English: If stopping treatment, as with other antiepileptic medicines, Keppra should be discontinued gradually to avoid an increase of seizures.
Danish: Ved ophør af behandling skal Keppra ligesom andre lægemidler mod epilepsi nedtrappes gradvist for at undgå en forøgelse af anfald.
English: Other medicines and Keppra
Danish: Brug af anden medicin sammen med Keppra
English: In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 AND UGT1A6) and epoxide hydroxylase activities.
Danish: In vitro-studier viste, at levetiracetam og dets primære metabolit ikke hæmmer de vigtigste human lever cytochrom P450 isoformer (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 og 1A2), glucuronyltransferase (UGT1A1 og UGT1A6) og epoxid hydroxylase aktiviteter.
English: UCB Pharma Romania S.R.L.
Danish: UCB Pharma România S.R.L.
English: Contains E216, E218 and maltitol liquid.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder E 216, E 218 og flydende maltitol.
English: What Keppra contains The active substance is called levetiracetam.
Danish: Keppra indeholder: - Aktivt stof: levetiracetam.
English: Infants should start the treatment with Keppra 100 mg/ml oral solution.
Danish: Spædbørn bør starte behandlingen med Keppra 100 mg/ml oral opløsning.
English: 100 film-coated tablets Component of a multipack, can't be sold separately.
Danish: Del af en multipakning, sælges ikke separat.
English: Example: if your daily dose is 1000 mg, your reduced starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Danish: Eksempel: Hvis Deres daglige dosis er 1.000 mg, er Deres lavere start-dosis 2 tabletter på 250 mg om morgenen og 2 tabletter på 250 mg om aftenen.
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetamtreated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behavior Checklist).
Danish: Resultater relateret til adfærds- og følelsesmæssig funktion indikerede en forværring af aggressiv adfærd hos patienter behandlet med levetiracetam, vurderet på en standardiseret og systematisk måde ved brug af et valideret værktøj (CBLCAchenbach Child Behavior Checklist).
English: Keppra concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Danish: Keppra-koncentrat er kun til intravenøs anvendelse, og den anbefalede dosis skal fortyndes i mindst 100 ml kompatibel opløsningsvæske og administreres intravenøst som en 15-minutters intravenøs infusion (se pkt.
English: Film-coating: Polyvinyl alcohol-part. hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, colourants*.
Danish: Filmovertræk: Delvist hydrolyseret polyvinylalkohol, titandioxid (E 171), macrogol 3350, talcum, farvestoffer*.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.