FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of Clostridium difficile infection-associated diarrhoea and colitis In the clinical development program of teicoplanin, three open, non-controlled studies were conducted with teicoplanin IV formulation administered orally for antibiotic-associated diarrhea (AAD) and 1 Wiggins KJ, Cochrane Collaboration review and meta-analysis 2008.
Danish: I det kliniske udviklingsprogram for teicoplanin blev der udført tre åbne, ikke kontrollerede undersøgelser med i.v.-formuleringen af teicoplanin, der blev administreret oralt mod antibiotikaassocieret diarré (AAD) og pseudomembranøs colitis (PMC) forårsaget af C. difficile.
English: 4 Reed MD, Yamashita TS, Myers CM, et al.
Danish: Reed MD, Yamashita TS, Myers CM, et al. The pharmacokinetics of teicoplanin in infants and children.
English: • The Committee reviewed the available data on submitted by the MAH from the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the SmPC.
Danish: • udvalget gennemgik markedsføringstilladelsesindehaverens dokumentation for den foreslåede harmonisering af produktinformation i form af data fra eksisterende kliniske undersøgelser, lægemiddelovervågningsdata og den publicerede litteratur,
English: Section 4.7 - Effects on ability to drive and use machines The wording of the CSP agreed during the PSUR work-sharing procedure (GR/H/PSUR/0001/001) was considered to be acceptable by the CHMP.
Danish: Punkt 4.7 - Virkning på evnen til at føre motorkøretøj og betjene maskiner CHMP godkendte ordlyden af de centrale sikkerhedsoplysninger, der blev aftalt under PSURarbejdsdelingsproceduren (GR/H/PSUR/0001/001).
English: Since safety data for the loading dose of12mg/kg bid (24mg/kg/day) is limited, the MAH has been requested by the CHMP to conduct a post-authorisation safety study (PASS) to evaluate the safety of the higher loading dose of 12mg/kg bid.
Danish: Da der kun findes begrænsede sikkerhedsdata om initialdoseringen på 12 mg/kg to gange dagligt (24 mg/kg/dag), har CHMP anmodet indehaveren af markedsføringstilladelsen om at udføre en sikkerhedsundersøgelse efter markedsføring (PASS) til vurdering af sikkerheden af den højere initialdosering på 12 mg/kg to gange dagligt.
English: monograph.
Danish: eller i.m.
English: • Bone and joint infections
Danish: • Infektioner i knogler og led
English: A statement regarding the absence of specific interaction studies has been added to the SmPC by the MAH and agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen har i produktresuméet tilføjet en erklæring om de manglende specifikke interaktionsundersøgelser, hvilket godkendtes af CHMP.
English: Since safety data for the loading dose of 12mg/kg bid (24mg/kg/day) is limited, the MAH has agreed to the request made by the CHMP to perform an appropriate post authorisation safety study (PASS) to evaluate the safety of the higher loading dose of 12mg/kg bid (24mg/kg/day).
Danish: Da der kun findes begrænsede sikkerhedsdata om initialdoseringen på 12 mg/kg to gange dagligt (24 mg/kg/dag), har indehaveren af markedsføringstilladelsen indvilliget i CHMP's anmodning om at udføre en fyldestgørende sikkerhedsundersøgelse efter markedsføring (PASS) til vurdering af sikkerheden af den højere initialdosering på 12 mg/kg to gange dagligt (24 mg/kg/dag).
English: No data in support of the use of teicoplanin in the prevention of infective endocarditis was submitted.
Danish: Vedrørende forebyggelse af infektiøs endokarditis blev der ikke forelagt data.
English: The proposed harmonised SmPC reflecting the changes was considered to be acceptable by the CHMP.
Danish: CHMP godkendte det foreslåede harmoniserede produktresumé, der afspejler ændringerne.
English: Package Leaflet (PL)
Danish: Bilag II
English: The CHMP concluded that teicoplanin should be indicated in complicated SSTIs i.e. severe cases, but not for the treatment of minor SSTIs in line with the British Society for Antimicrobial Chemotherapy (BSAC) guideline, which does not recommend systemic antibiotics for the treatment of minor SSTIs.
Danish: Dette er i overensstemmelse med retningslinjerne fra British Society for Antimicrobial Chemotherapy (BSAC), som ikke anbefaler systemiske antibiotika ved SSTI.
English: This information has been proposed by the MAH in the harmonised SmPC and was considered to be acceptable by the CHMP.
Danish: Denne oplysning foreslog indehaveren af markedsføringstilladelsen at indsætte i det harmoniserede produktresumé, hvilket blev godkendt af CHMP.
English: Section 4.2 - Posology and method of administration Posology
Danish: Punkt 4.2 - Dosering og administration
English: The wording of the CSP agreed during the PSUR work-sharing procedure (number GR/H/PSUR/0001/001) was considered to be acceptable by the CHMP.
Danish: CHMP godtog den ordlyd af de centrale sikkerhedsoplysninger, der blev aftalt under PSUR-arbejdsdelingsproceduren (nr. GR/H/PSUR/0001/001).
English: In accordance with the CHMP guideline and the SmPC Guideline, the applicant has also inserted information with regard to fertility.
Danish: Ansøgeren har desuden indsat oplysninger vedrørende fertilitet i overensstemmelse med CHMP's retningslinjer og retningslinjerne for produktresuméer.
English: agitation and vomiting are confounded by concomitant treatments or clinical situation.
Danish: Hos den pædiatriske population blev der i de fleste tilfælde af overdosering med teicoplanin ikke indberettet bivirkninger; ekscitation og opkastning er konfunderet af samtidig anden behandling eller af den kliniske situation.
English: • Peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD) There is evidence to suggest that teicoplanin is effective in this indication.
Danish: • Peritonitis i forbindelse med vedvarende ambulant peritonealdialyse (CAPD)
English: Prophylaxis of infections caused by Gram-positive microorganisms Four prophylaxis comparative studies were conducted.
Danish: Der blev udført fire sammenlignende undersøgelser af forebyggelse.
English: In line with the CHMP Guideline on the Evaluation of Medicinal Products indicated for Treatment of Bacterial Infections (CPMP/EWP/558/95 rev 2), it was considered acceptable to further qualify the indications.
Danish: Det blev anset for acceptabelt at fastlægge indikationerne nærmere, hvilket er i overensstemmelse med CHMP's vejledning om vurdering af lægemidler til behandling af bakterielle infektioner (“Guideline on the Evaluation of Medicinal Products indicated for Treatment of Bacterial Infections” (CPMP/EWP/558/95 rev 2)).
English: In Study EG-87-42 (European Multicentre Study), the clinical and bacteriological efficacy of teicoplanin has been shown in UTI (8% of all infection sites).
Danish: Virkningen af teicoplanin er påvist klinisk og bakteriologisk ved urinvejsinfektioner (8 % af alle infektiøse foci) i undersøgelse EG-87-42 (den europæiske multicenterundersøgelse).
English: Section 4.4 - Special warnings and precautions for use The wording of the core safety profile (CSP), currently approved in the context of the PSUR worksharing procedure number GR/H/PSUR/0001/001, was proposed by the MAH for the harmonised SmPC.
Danish: Til det harmoniserede produktresumé påtænkte indehaveren af markedsføringstilladelsen at anvende ordlyden af de centrale sikkerhedsoplysninger (CSP), der på nuværende tidspunkt er godkendt i forbindelse med arbejdsdelingsproceduren GR/H/PSUR/0001/001 vedrørende PSUR.
English: Other studies were also discussed by the MAH.
Danish: Også andre undersøgelser blev gennemgået af indehaveren af markedsføringstilladelsen.
English: EU/1/14/937/001 Gazyvaro
Danish: EU/1/14/937/001
English: 1000 mg Concentrate for solution for infusion
Danish: 1000 mg Koncentrat til infusionsvæske, opløsning
English: 40 ml
Danish: Hætteglas (glas) 40 ml hætteglas
English: EMA Number
Danish: EMA´s procedurenr.
English: You should be aware that both of these conditions may be caused by this type of medicine.
Danish: Du skal være klar over, at begge disse tilstande kan forårsages af denne type medicin.
English: General supportive measures should be employed.
Danish: Generelle, understøttende foranstaltninger bør indføres.
English: This is because it is not known if INVEGA is safe or effective in these age groups.
Danish: Dette skyldes, at det ikke vides, om INVEGA er sikkert eller effektivt i disse aldersgrupper.
English: Date of first authorisation: 25 June 2007 Date of latest renewal: 14 May 2012
Danish: Dato for første markedsføringstilladelse: 25. juni 2007 Dato for seneste fornyelse: 14. maj 2012
English: The 1-7 version of the PANSS was used.
Danish: Version 1-7 af PANSS blev anvendt.
English: Close supervision and monitoring should continue until the patient recovers.
Danish: Tæt supervision og monitorering bør fortsættes, indtil patienten er restitueret.
English: Potential for gastrointestinal obstruction
Danish: Potentiale for gastrointestinal obstruktion
English: - if you have epilepsy.
Danish: • hvis du har epilepsi.
English: There was no clear dose relationship.
Danish: Der var ingen tydelig dosissammenhæng.
English: Povidone (K29-32)
Danish: Povidon (K29-32)
English: All tablets are available in the following pack sizes:
Danish: Alle tabletter leveres i følgende pakningsstørrelser:
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Danish: I visse tilfælde er der rapporteret om forudgående vægtstigning, hvilket kan være en prædisponerende faktor.
English: There were insufficient data to explore differential effects based on race.
Danish: Der var ikke tilstrækkelige data til at undersøge forskelle i virkning baseret på race.
English: - if you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
Danish: • hvis du ved, at du tidligere har haft et lavt niveau af hvide blodlegemer (som måske eller måske ikke var forårsaget af andre lægemidler).
English: The difference is unlikely to be of clinical relevance, though.
Danish: Forskellen har imidlertid næppe klinisk relevans.
English: This medicine should be taken every morning with breakfast or without breakfast, but in the same way every day.
Danish: Dette lægemiddel skal tages hver morgen med eller uden morgenmad, men på samme måde hver dag.
English: If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.
Danish: Hvis denne kombination anses for nødvendig, især i terminalfasen af Parkinsons sygdom, bør den laveste effektive dosis af hver behandling ordineres.
English: Approximately 80% of the administered radioactivity was recovered in urine and 11% in the faeces.
Danish: Ca. 80 % af den administrerede radioaktivitet blev genfundet i urinen og 11 % i fæces.
English: Dosing was in the morning without regard to meals.
Danish: Dosis blev administreret om morgenen uden hensyn til måltider.
English: Do not alternate between taking this medicine with breakfast one day and without having breakfast the next day.
Danish: Du må således ikke skifte mellem at tage dette lægemiddel sammen med morgenmaden den ene dag og uden morgenmad den næste dag.
English: Your doctor will decide how much to give you.
Danish: Lægen vil beslutte, hvor meget du skal have.
English: It should be noted that a broader spectrum of symptoms are included that do not necessarily have an extrapyramidal origin.
Danish: Det er vigtigt at lægge mærke til, at det også omfatter et bredere spektrum af symptomer, som ikke nødvendigvis er af ekstrapyramidal oprindelse.
English: It takes 2-3 weeks for full induction to be achieved and upon discontinuation of the inducer the effect wears off over a similar time period.
Danish: Det tager 2-3 uger at opnå fuld induktion, og efter seponering af induktoren aftager effekten i løbet af en tilsvarende periode.
English: Paliperidone is rapidly distributed.
Danish: Paliperidon fordeles hurtigt.
English: Patients should be informed to seek urgent medical care in case that priapism has not been resolved within 3-4 hours.
Danish: Patienter bør informeres om øjeblikkeligt at søge læge, hvis priapismen ikke er forsvundet inden for 3-4 timer.
English: This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
Danish: Dette skal tages i betragtning i tilfælde, hvor din fulde opmærksomhed er påkrævet, f.eks. når du fører motorkøretøj eller arbejder med maskiner.
English: This depends on how well the medicine works for you.
Danish: Det afhænger af, hvor godt medicinen virker på dig.
English: - if you or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.
Danish: • hvis du eller en anden i din familie har haft blodpropper, da brug af antipsykotika har været forbundet med dannelsen af blodpropper.
English: The sedative effect of INVEGA should be closely monitored in this population.
Danish: INVEGAs sederende virkning skal monitoreres nøje i denne population.
English: In adolescents, weight gain should be assessed against that expected with normal growth.
Danish: Hos unge skal vægtøgning vurderes i forhold til det, der må forventes i forbindelse med normal vækst.
English: The following terms and frequencies are applied: 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), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Danish: Følgende termer og hyppighedsangivelser anvendes: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1000), meget sjælden (< 1/10.000) samt ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to INVEGA is known.
Danish: Patienterne bør derfor advares om, at de ikke må føre motorkøretøj eller betjene maskiner, før deres individuelle følsomhed over for INVEGA kendes.
English: Biotransformation and elimination One week following administration of a single oral dose of 1 mg immediate-release
Danish: Biotransformation og elimination En uge efter administration af en enkelt peroral dosis på 1 mg
English: The safety profile of risperidone may be pertinent.
Danish: Risperidons sikkerhedsprofil kan være relevant.
English: INVEGA can help alleviate the symptoms of your disease and stop your symptoms from coming back.
Danish: INVEGA kan lindre symptomerne på din sygdom og forhindre, at symptomerne kommer igen.
English: Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
Danish: Etablér og fasthold frie luftveje, og sørg for tilstrækkelig iltning og ventilation.
English: You should not take this medicine during pregnancy unless this has been discussed with your doctor.
Danish: Du må ikke tage dette lægemiddel under graviditet, medmindre du har drøftet det med lægen.
English: For all 3 studies, an active control (olanzapine at a dose of 10 mg) was included.
Danish: I alle tre studier blev der inkluderet et aktivt kontrolstof (olanzapin i en dosis på 10 mg).
English: Body temperature regulation
Danish: Regulering af legemstemperatur
English: Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias.
Danish: Kardiovaskulær monitorering bør iværksættes straks og bør omfatte kontinuerlig elektrokardiografisk monitorering for eventuel arytmi.
English: INVEGA contains a racemic mixture of (+)- and (-)-paliperidone.
Danish: INVEGA indeholder en racemisk blanding af (+)- og (-)-paliperidon.
English: - if you have Parkinson's disease or Dementia.
Danish: • hvis du har Parkinsons sygdom eller lider af demens.
English: The pharmacological activity of the (+)- and (-)-paliperidone enantiomers are qualitatively and quantitatively similar.
Danish: Den farmakologiske aktivitet for (+)- og (-)paliperidonenantiomererne er kvalitativt og kvantitativt ens.
English: - if you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour.
Danish: • hvis du har et unormalt højt niveau af hormonet prolaktin i blodet, eller hvis du muligvis har en prolaktinafhængig svulst.
English: Since this medicine can lower blood pressure, care should be taken when this medicine is taken with other medicines that lower blood pressure.
Danish: Da dette lægemiddel kan sænke blodtrykket, bør du være forsigtig, hvis du tager dette lægemiddel sammen med anden medicin, som også kan sænke blodtrykket.
English: - if you have prolonged and/or painful erection.
Danish: • hvis du har forlænget og/eller smertefuld rejsning.
English: An examination of population subgroups did not reveal any evidence of differential responsiveness on the basis of gender, age, or geographic region.
Danish: En undersøgelse af populationsundergrupper afslørede ingen tegn på forskelle i respons på basis af køn, alder eller geografisk område.
English: Subjects were 12-17 years of age and met DSM-IV criteria for schizophrenia.
Danish: Deltagerne var 12-17 år gamle og opfyldte DSM-IV-kriterierne for skizofreni.
English: Antiemetic effect
Danish: Antiemetisk effekt
English: All tested doses of INVEGA separated from placebo on day 4 (p < 0.05).
Danish: Alle undersøgte INVEGA-doser adskilte sig fra placebo på dag 4 (p < 0,05).
English: - if you have diseases associated with diarrhoea.
Danish: • hvis du har sygdomme ledsaget af diaré.
English: - if you have difficulty controlling core body temperature or overheating.
Danish: • hvis du har vanskeligheder ved at kontrollere din krops kernetemperatur eller bliver overophedet.
English: Paliperidone was not teratogenic in animal studies, but other types of reproductive toxicity were observed (see section 5.3).
Danish: Paliperidon var ikke teratogent i dyrestudier, men der blev observeret andre former for reproduktiv toksicitet (se pkt.
English: • difficulty falling or staying asleep
Danish: • problemer med at falde i søvn eller sove igennem
English: If you have any of these conditions, please talk to your doctor as he/she may want to adjust your dose or monitor you for a while.
Danish: Hvis du har nogle af disse sygdomme, bør du tale med lægen, som muligvis vil justere din dosis eller kontrollere dig i en periode.
English: Administration of activated charcoal together with a laxative should be considered.
Danish: Indgift af aktivt kul sammen med et laksans bør overvejes.
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with INVEGA and preventive measures undertaken.
Danish: Da patienter behandlet med antipsykotika ofte viser erhvervede risikofaktorer for VTE, bør alle mulige risikofaktorer for VTE identificeres før og under behandling med INVEGA, og forebyggende foranstaltninger iværksættes.
English: • feeling sleepy or less alert
Danish: • følelse af at være søvnig eller mindre opmærksom
English: In addition, the difference in the percentage of patients demonstrating ≥ 20% improvement in PANSS total score at week 26 between the two treatment groups was numerically similar.
Danish: Derudover var forskellen i den procentdel af patienter, der opnåede en forbedring i samlet PANSS-score på ≥ 20 % ved uge 26, numerisk ens mellem de to behandlingsgrupper.
English: Four metabolic pathways have been identified in vivo, none of which accounted for more than 6.5% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Danish: Der er identificeret fire metaboliske processer in vivo, hvoraf ingen udgjorde mere end 6,5 % af dosis, nemlig dealkylering, hydroxylering, dehydrogenering og benzisoxazolspaltning.
English: Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring.
Danish: Andre dopaminantagonister har ved administration til gravide dyr forårsaget negative virkninger på indlæring og motorisk udvikling hos afkommet.
English: The population included subjects with schizoaffective bipolar and depressive types.
Danish: Populationen inkluderede forsøgspersoner med skizoaffektive bipolære og depressive typer.
English: Since this medicine works primarily in the brain, interference from other medicines (or alcohol) that work in the brain could occur due to additive effect on brain function.
Danish: Eftersom dette lægemiddel primært virker på hjernen, kan der opstå forstyrrelser fra anden medicin (eller alkohol), som også virker på hjernen, som følge af den yderligere virkning på hjernens funktion.
English: In the case of acute overdosage, the possibility of multiple medicinal product involvement should be considered.
Danish: I tilfælde af akut overdosering bør der tages højde for muligheden for polyfarmaci.
English: The terminal elimination half-life of paliperidone is about 23 hours.
Danish: Paliperidons terminale eliminationshalveringstid er ca. 23 timer.
English: This difference is largely explained by differences in lean body mass and creatinine clearance between men and women.
Danish: Denne forskel kan generelt forklares ved forskelle i fedtfri legemsmasse og kreatininclearance mellem mænd og kvinder.
English: Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Danish: Blandt dem, der blev behandlet med risperidon var mortaliteten 4 % i forhold til 3,1 % for dem, som fik placebo.
English: An effect of INVEGA on depressive symptoms was not demonstrated in these studies, but has been demonstrated in a long-term study with the long-acting injectable formulation of paliperidone (described further down in this section).
Danish: Der blev ikke påvist en effekt af INVEGA på depressive symptomer i disse studier, men den er blevet påvist i et langtidsstudie med den langtidsvirkende injicerbare formulering af paliperidon (beskrevet senere i dette punkt).
English: The apparent volume of distribution is 487 L. The plasma protein binding of paliperidone is 74%.
Danish: Det tilsyneladende fordelingsvolumen er 487 l. Paliperidons plasmaproteinbinding er 74 %.
English: Aripiprazole 5-15 mg N=114
Danish: Aripiprazol 5-15 mg N = 114
English: At 2.5 mg/kg/day in females, an effect on learning and memory was observed.
Danish: Ved 2,5 mg/kg/dag observeredes en virkning på indlæring og hukommelse hos hundyr.
English: • increased insulin (a hormone that controls blood sugar levels) in your blood.
Danish: • forhøjet insulin (et hormon, som kontrollerer blodsukkerniveauet) i blodet.
English: Initial dose titration is not required.
Danish: Initial dosistitrering er ikke nødvendig.
English: • leaking milk from the breasts in girls
Danish: • mælkeflåd fra brysterne hos piger
English: INVEGA should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Danish: INVEGA bør anvendes med forsigtighed sammen med lægemidler, der øger aktiviteten i centralnervesystemet (psykostimulanser som f.eks. methylphenidat).
English: The active substance is contained within a non-absorbable shell designed to release the active substance at a controlled rate.
Danish: Det aktive stof er indkapslet i en ikke-absorberbar skal, som afgiver det aktive stof i kontrollerede mængder.
English: - if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia).
Danish: • hvis du nogensinde har oplevet unormale bevægelser af tungen eller ansigtet (tardiv dyskinesi).
English: • are a man and experience prolonged or painful erection.
Danish: • er mand og får langvarig eller smertefuld erektion.
English: INVEGA should not be used during pregnancy unless clearly necessary.
Danish: INVEGA bør ikke anvendes under graviditet, medmindre det er strengt nødvendigt.
English: In the long-term 2-year study, the subjects who were exposed to INVEGA during both the double-blind and open-label studies reported a modest weight gain (4.9 kg).
Danish: I det langvarige studie på 2 år rapporterede de deltagere, der blev eksponeret for INVEGA i både det dobbeltblinde og det åbne studie, en moderat vægtøgning (4,9 kg).