FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Buvidal, buprenorphine, is a partial opioid agonist (it acts like an opioid drug but less powerfully).
Danish: Det aktive stof i Buvidal, buprenorphin, er en partiel opioid-agonist (det virker som et opioidt lægemiddel, men mindre kraftfuldt).
English: The first dose of Buvidal is given at least 24 hours after the patient last used methadone.
Danish: Den første Buvidal-dosis gives mindst 24 timer, efter at patienten sidst har taget metadon.
English: The most common side effects with buprenorphine (which may affect more than 1 in 10 people) are headache, nausea (feeling sick), hyperhidrosis (excessive sweating), insomnia (difficulty sleeping), drug withdrawal syndrome and pain.
Danish: De hyppigste bivirkninger ved buprenorphin (som kan forekomme hos mere end 1 ud af 10 patienter) er hovedpine, kvalme, hyperhidrose (øget svedafsondring), søvnløshed, abstinenssymptomer og smerter.
English: The first dose of Buvidal is given when the patient shows clear signs of withdrawal.
Danish: Den første Buvidal-dosis gives, mens patienten viser tydelige tegn på abstinenser.
English: Buvidal must not be used in patients with severe respiratory insufficiency (inability to breathe properly) and severe liver problems and in patients who are intoxicated with alcohol or are experiencing alcohol withdrawal symptoms.
Danish: Buvidal må ikke anvendes hos patienter med svært nedsat vejrtrækningsfunktion, alvorlige leverproblemer, eller hos patienter, der er forgiftet med alkohol, eller som har symptomer på alkoholabstinenser.
English: For patients dependent on long-acting opioids (e.g. methadone), the dose of methadone is reduced to below 30 mg per day before starting Buvidal.
Danish: Til patienter, der er afhængige af langtidsvirkende opioider (f.eks. metadon), reduceres dosen af metadon til under 30 mg pr. dag inden behandling med Buvidal påbegyndes.
English: In this study, Buvidal was compared with sublingual tablets containing buprenorphine and another medicine, naloxone (which is used to prevent misuse).
Danish: I dette studie blev Buvidal sammenlignet med sublinguale tabletter, der indeholdt buprenorphin og et andet lægemiddel, naloxon (som anvendes til at forebygge misbrug).
English: Buvidal contains the active substance buprenorphine and is a ‘hybrid medicine'.
Danish: Buvidal indeholder det aktive stof buprenorphin og er et "hybridt lægemiddel".
English: These patients should be started on weekly doses of Buvidal before moving to monthly injections.
Danish: Disse patienter skal påbegynde behandlingen med ugentlige Buvidal-doser, inden de går over til månedlige indsprøjtninger.
English: Patients who have taken buprenorphine before may be switched directly to weekly or monthly Buvidal injections.
Danish: Patienter, der har taget buprenorphin før, kan skifte direkte til ugentlige eller månedlige indsprøjtninger med Buvidal.
English: For the full list of side effects and restrictions of Buvidal, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Buvidal fremgår af indlægssedlen.
English: While Subutex is available as sublingual tablets (tablets to be placed under the tongue), Buvidal is available as a solution for injection under the skin.
Danish: Subutex fås som sublinguale tabletter (tabletter, der opløses under tungen), mens Buvidal er en injektionsvæske til indsprøjtning under huden.
English: Buvidal is given as an injection under the skin, either once a week or once a month.
Danish: Buvidal gives enten en gang om ugen eller hver måned som en injektion under huden.
English: How is Buvidal used?
Danish: Hvordan anvendes Buvidal?
English: What benefits of Buvidal have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Buvidal?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Buvidal have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Buvidal.
English: How does Buvidal work?
Danish: Hvordan virker Buvidal?
English: Intravenous use vial (glass)
Danish: Intravenøs anvendelse Hætteglas (glas) 1 hætteglas
English: These measures will help protect the environment.
Danish: Disse forholdsregler er med til at beskytte miljøet
English: One single administration is usually sufficient.
Danish: En enkelt administration er normalt tilstrækkelig.
English: Are you pregnant, or do you think you might be pregnant?
Danish: Er du gravid eller påtænker du at blive gravid?
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen refererer til den sidste dag i måneden.
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kunne skade dem, selv om deres symptomer er de samme som dine egne.
English: More than one of these four means of resistance may be present in the same organism.
Danish: Mere end en af disse fire resistensmåder kan være til stede i den samme organisme.
English: Your doctor will explain this to you.
Danish: Din læge vil informere dig om dette.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra en mikrobiologisk synsvinkel bør produktet bruges med det samme.
English: No case of overdose has been reported.
Danish: Ingen tilfælde af overdosering er blevet rapporteret.
English: For elderly patients the dosage recommendations are the same as for adults - without modification.
Danish: Til ældre patienter er dosis anbefalingerne de samme som for voksne - uden modifikation.
English: Species for which acquired resistance may be a problem
Danish: Arter for hvilke resistens kan udgøre et problem
English: Serum levels
Danish: Serum niveauer
English: Adults ≥ 17 years
Danish: Voksne ≥ 17 år
English: The possibility of sensitisation should be borne in mind.
Danish: Muligheden for sensibilisering bør overvejes.
English: If this happens, do not drive or use machines.
Danish: Hvis dette sker, skal du ikke køre eller betjene maskiner.
English: Further information
Danish: Yderligere information
English: Dosage recommendations for special indications should be taken into account.
Danish: Dosis anbefalinger for specielle indikationer bør tages i betragtning.
English: Dose adjustment may be necessary..
Danish: Dosis justering kan være nødvendig.
English: Controlled and validated aseptic conditions have to be observed.
Danish: Kontrolleret og validerede aseptiske forhold skal holdes under opsyn.
English: Its effectiveness in a number of clinically relevant infections has been established during more than ten years of therapeutical use.
Danish: Dets effektivitet mod en række klinisk relevante infektioner er blevet fastslået gennem mere end ti års terapeutisk anvendelse.
English: Benefit/risk considerations
Danish: Overvejelser om fordele/risici
English: There is no specific antidote.
Danish: Der er ingen specifik modgift.
English: Moreover half life is longer than in adults.
Danish: Desuden er halveringstiden længere end hos voksne.
English: Non-Linearity
Danish: Ikke-linearitet
English: These reactions have caused death in some cases.
Danish: Disse bivirkninger har i nogle tilfælde forårsaget død.
English: Despite the limited and somehow old scientific data, intensive search by the applicant did not reveal scientific evidence which makes it necessary to change these dosage recommendations which are authorised since years without safety concerns in several Member States.
Danish: På trods af de begrænsede og efterhånden gamle videnskabelige data viste ansøgerens intensive søgen ingen videnskabeligt beviser, der nødvendiggør ændring af disse dosisanbefalinger, som har været godkendt i mange år i adskillige medlemslande uden problemer med sikkerheden.
English: Minor prolongation in the prothrombin time has been described.
Danish: Mindre forlængelser af protrombin tid er blevet beskrevet.
English: Laboratory-diagnostic tests
Danish: Laboratorie-diagnosticerende tests
English: It has not been shown to possess any mutagenic activity.
Danish: Det er ikke påvist at have mutationsfremmende aktivitet.
English: C.F. Tietgens Boulevard 40 5220 Odense SØ, Denmark
Danish: C.F. Tietgens Boulevard 40 5220 Odense SØ, Danmark
English: This medicine has been prescribed for you.
Danish: Dette lægemiddel er ordineret til dig personligt.
English: Only clear solutions free of visible particles should be used.
Danish: Kun klare opløsninger fri for synlige partikler bør anvendes.
English: Opened & after reconstitution:
Danish: Åbnet og efter rekonstituering:
English: Sandoz Limited Woolmer way Bordon, Hants, GU35 9QE United Kingdom
Danish: Sandoz Limited Woolmer way Bordon, Hants, GU35 9QE Storbritannien
English: Only clear solutions should be used.
Danish: Kun klare opløsninger må anvendes.
English: Phlebitis following intravenous administration.
Danish: Phlebitis efter intravenøs administration.
English: Usually only one dose is given
Danish: Sædvanligvis gives kun en dosis.
English: Serum concentrations should be monitored, however, to determine whether dosage adjustments are necessary, since the elimination rate in these patients may be reduced.
Danish: Men serum koncentrationer bør monitoreres for at bestemme om dosis justering er nødvendig, da elimineringsraten hos disse patienter kan reduceres.
English: This non-linearity is explained by a concentration dependent decrease of binding to plasma proteins which leads to a respective increase in distribution and elimination.
Danish: Denne ikke-linearitet er forklaret ved en koncentration afhængig reduktion af binding til plasma proteiner som føre til en respektiv forøgelse af distribution og eliminering.
English: The urine concentrations are 5-10 times higher than those found in the plasma.
Danish: Urin koncentrationen er 5-10 gange højere end dem fundet i plasma.
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs hele denne indlægsseddel omhyggeligt, inden du begynder at anvende dette lægemiddel.
English: and 0.25 µg/ml for Neisseria gonorrhoea.
Danish: 0,25 µg/ml for Neisseria gonoré.
English: The CHMP therefore agreed to recommend the following dosage recommendation:
Danish: CHMP blev derfor enige om at anbefale følgende dosisanbefaling:
English: It may continue for a total of 7 to 14 days.
Danish: Den kan forsætte i op til 7 -14 dage.
English: Although this medicine is not known to harm the unborn child, it will only be given to a pregnant woman if it is really necessary.
Danish: Selvom denne medicin ikke er kendt for at skade det ufødte barn, bør den ikke anvendes til en gravid kvinde, medmindre det er strengt nødvendigt.
English: The mean volume of distribution in healthy adults is 0.13 l/kg.
Danish: Den hovedsagelige volumen af distributionen hos raske voksne er 0,13 l/kg.
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser vil nødvendigvis blive markedsført.
English: Section 4.8
Danish: Afsnit 4.8
English: In this section undesirable effects are defined as follows:
Danish: I dette afsnit er bivirkninger defineret som nedenfor:
English: Breakpoints
Danish: Break-points
English: The duration of injection is between 2 and 4 minutes.
Danish: Injektionens varighed er mellem 2 og 4 minutter.
English: Intramuscular injection of the medicinal product is contraindicated:
Danish: Intramuskulær injektion af medicinal produktet er kontraindikeret:
English: Oliguria, increase in serum creatinine.
Danish: Oliguri, forøgelse af serum creatinin.
English: Typical signs of overdose can be expected to correspond to the adverse reaction profile.
Danish: Typiske tegn på overdosering kan forventes at svare til bivirkningsprofilen.
English: The normal duration of therapy depends on the characteristics of the infection.
Danish: Den normale behandlingsvarighed afhænger af infektionens karakteristik.
English: Treatment with injection into a muscle is only justified in exceptional cases and after a careful risk/benefit evaluation.
Danish: Behandling med injektion i musklen er kun forsvarlig i exceptionelle tilfælde og efter en nøje risiko/fordel evaluering.
English: It also depends on your weight and how your kidneys are working.
Danish: Det afhænger også af hvad du vejer og hvordan dine nyrer fungerer.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2oC to 8oC.
Danish: Kemisk og fysisk stabilitet er blevet demonstreret for 24 timer ved 2°C til 8°C.
English: Principal chemical intolerances
Danish: Principiel kemisk intolerance
English: See also section "Principal chemical intolerances“.
Danish: Se også ”Principiel kemisk intolerance”.
English: Superinfections with non- susceptible micro-organisms.
Danish: Superinfektioner med ikke-modtagelige mikroorganismer.
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Udbredelsen af opnået resistance kan variere geografisk og med tid for udvalgte arter og lokal information om resistance er at fortrække, specielt når man behandler alvorlige infektioner.
English: If the treatment course is stopped too early the infection may start up again.
Danish: Hvis du stopper for hurtigt, kan infektionen komme igen.
English: Each administration of antibiotics can lead to multiplication of pathogens resistant to the active substance used.
Danish: Hver administration af antibiotika kan føre til mangedobling af patogen resistens overfor det aktive stof.
English: Generally the administration of ceftriaxone should be continued for at least 48 to 72 hours beyond the normalisation of body temperature and evidence of bacterial eradication has been obtained.
Danish: Generelt bør ceftriaxon administrationen fortsætte i mindst 48 til 72 timer ud over normaliseringen af kropstemperaturen og bevis på bakteriel udryddelse er opnået.
English: The high risk of precipitation is due to the low blood volume of the newborns.
Danish: Den høje risiko for udfældning skyldes den lave blodvolumen hos de nyfødte.
English: This volume of 20.5 ml reconstituted solution for infusion should be administered immediately as a short time infusion over 30 minutes.
Danish: Denne volumen på 20,5 ml rekonstitueret infusionsopløsning bør administreres straks som en kort tids infusion på 30 minutter.
English: Reconstituted solutions should be inspected visually.
Danish: Den rekonstituerede opløsning bør inspiceres visuelt.
English: The usual doses are:
Danish: Den sædvanlige dosering er:
English: There are no data on the use of ceftriaxone in pregnant women.
Danish: Der foreligger ingen data på brugen af ceftriaxon til gravide kvinder.
English: Children between 15 days and 12 years old
Danish: Børn mellem 15 dage og 12 år
English: Normal dosage
Danish: Normal dosis
English: Smaller amounts for lower doses calculated on an mg/kg bodyweight basis have to be calculated proportionately.
Danish: Mindre mængder til lavere doser kalkuleret ud fra en mg/kg kropsvægt skal kalkuleres proportionalt.
English: With the exception of elimination half-life, all pharmacokinetic parameters are dose-dependent.
Danish: Med undtagelse af eliminerings halveringstid, er alle farmakokinetiske egenskaber dosis afhængige.
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg dit apotek, hvad du skal gøre ved medicin, der ikke længere er nødvendig.
English: Ceftriaxone is usually given once a day.
Danish: Ceftriaxon gives sædvanligvis én gang daglig.
English: In the rare cases in which the precipitates are accompanied by clinical symptoms such as pain, symptomatic measures are recommended.
Danish: I de sjældne tilfælde, hvor udfældningen er ledsaget af kliniske symptomer så som smerte, er symptomatiske metoder anbefalet.
English: • during pregnancy and lactation.
Danish: • under graviditet og amning.
English: The majority of the studies used 50 mg/kg/day in neonates in the treatment of infections.
Danish: I størstedelen af undersøgelserne anvendtes 50 mg/kg/dag til nyfødte til behandling af infektioner.
English: The CHMP agreed also on the following changes to the SPC:
Danish: CHMP blev også enige om følgende ændringer til produktresumeet:
English: These opacities usually occurred only after administration of higher doses than the recommended standard doses.
Danish: Disse opaciteter optræder oftest kun efter indtagelse af højere doser end de anbefalede standard doser.
English: Signs of consecutive secondary infections with such pathogens (including candida and fungi) are to be heeded.
Danish: Tegn på fortløbende sekundære infektioner med sådanne patogene (inklusiv candida og svamp) bør bemærkes.
English: Biochemiestraße 10
Danish: Biochemiestrasse 10
English: These types of antibiotic are similar to penicillin.
Danish: Denne type antibiotika virker på samme måde som penicilliner.
English: In case of terminal renal insufficiency, the half-life is distinctively higher and reaches approximately 14 hours.
Danish: I tilfælde af uhelbredelig nyre insufficiens er halveringstiden væsentligt højere og når ca. 14 timer.
English: During the first few weeks of life the ability to clear ceftriaxone changes although the exact time point at which this occurs has not been truly determined.
Danish: I de første få uger af den nyfødtes liv ændres evnen til at udskille ceftriaxon, selvom det præcise tidspunkt, hvor dette sker, ikke er blevet fastslået med sikkerhed.
English: The reconstituted product is for single use only and any unused solution must be discarded.
Danish: Det rekonstituerede produkt er kun til engangs brug og ubrugt opløsning skal kasseres.
English: Non-enzymatic methods for glucose determinations in urine may yield false-positive results.
Danish: Ikke-enzymiske metoder til at fastslå glucose i urinen kan give falsk-positive resultater.
English: The proposed dosage range from 20-50-80 mg/kg/day allows the continuation of long lasting therapeutic experience supported by the recommendations of learned societies.
Danish: Det foreslåede dosisområde fra 20-50-80 mg/kg/dag muliggør fortsatte erfaringer med langtidsbehandling, der understøttes af anbefalingerne fra videnskabelige selskaber.
English: • bacterial meningitis
Danish: • Bakteriel meningitis
English: There are no other ingredients.
Danish: Produktet indeholder ikke andre indholdsstoffer.
English: In this respect, there may be some cross-reactivity with penicillins.
Danish: Desangående kan der forekomme kryds reaktioner med penicillin.
English: Antiperistaltics are contraindicated.
Danish: Antiperistaltika er kontraindikeret.
English: If severe, persistent diarrhoea occurs during or after treatment, pseudomembranous colitis which is a serious, even life-threatening complication mostly caused by clostridium difficile, should be considered,.
Danish: Hvis alvorlig, vedvarende diarré optræder under eller efter behandling bør pseudomembranous colitis, som er en alvorlig, livstruende komplikation, oftest forårsaget af clostridium difficile, overvejes.
English: Therefore taking into the consideration the long clinical experience in terms of efficacy and safety with the proposed posology further clinical trials was considered unnecessary.
Danish: I betragtning af den lange kliniske erfaring med hensyn til effekt og sikkerhed med den foreslåede dosering blev det derfor anset som unødvendigt at foretage yderligere kliniske undersøgelser.
English: 50-60 % of ceftriaxone is eliminated as an unchanged active substance in the urine whilst the remainder is excreted via the bile into the faeces as microbiologically inactive metabolites.
Danish: 50-60 % af ceftriaxon er elimineret som en uændret aktiv substans i urinen mens resten er udskilles via galden i afføringen som mikrobiologiske inaktive metabolitter.
English: This medicine can be affected by other medicines that are removed by the kidneys.
Danish: Denne medicin kan blive påvirket af anden medicin som bliver udskilt af nyrerne.
English: Symptomatic therapeutic measures are indicated.
Danish: Symptomatiske terapeutiske metoder er indikeret.
English: An injection into the blood vessels must be strictly avoided.
Danish: En injektion ind i blodårerne skal undgås.
English: This medicine can also alter the results of non-enzymatic urine tests for sugar.
Danish: Denne medicin kan også påvirke resultatet af, ikke-enzymatisk urintest for sukker.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Du bør konsultere din læge eller apoteket, hvis du er usikker.
English: This diagnosis should be considered in patients who develop diarrhoea during or following treatment with ceftriaxone (see.
Danish: Denne diagnose bør overvejes hos patienter som udvikler diarre under eller efter behandling med ceftriaxon (se pkt.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such, that the utility of the agent in at least some types of infections is questionable.
Danish: Hvis nødvendigt bør man rådføre eksperter når den lokale udbredelse af resistance er af sådanne art at anvendeligheden af præparatet ved visse typer af infektioner er tvivlsom.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, ANSØGERE, INDEHAVER AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: There are many medicines that can do this, so you should check with your doctor or pharmacist before taking this medicine.
Danish: Der er meget medicin som kan gøre det, så du skal informere din læge eller apoteket før du tager denne medicin.
English: These undesirable effects are mostly mild and frequently subside during, otherwise after discontinuation of therapy.
Danish: Disse bivirkninger er oftest milde og aftager ofte under eller efter afslutning af behandlingen.
English: After determining the sensitivity of the pathogen the dose may be reduced accordingly.
Danish: Efter at have fastslået følsomheden af patogenet, kan dosis reduceres som følge heraf.
English: The reconstituted solution should be shaken up to 60 seconds to ensure complete dissolution of ceftriaxone.
Danish: Den rekonstitueret opløsning bør rystes i op til 60 sekunder for at sikre fuldstændig opløsning af ceftriaxon.
English: Patients with impaired renal and/or liver function:
Danish: Patienter med nedsat nyre og/eller leverfunktion:
English: For this reason, no increase in the serum levels is to be expected in coincident administration of probenecid and is actually - even at higher dosage e.g. with 1-2 g probenecid - not found.
Danish: På grund af dette, kan ingen forøgelser i serum niveauer forventes ved samtidig administration af probenecid og er faktisk, selv ved højere doser f..eks. 1-2 g probencid, ikke fundet.
English: Pseudomembranous colitis has been reported with almost all antibiotics, including ceftriaxone.
Danish: Pseudomembran colitis er rapporteret ved brug af næsten alle antibiotika inklusiv ceftriaxon.
English: This solution has to be transferred into a suitable infusion bag.
Danish: Denne opløsning skal overføres til en passende infusionspose.
English: This is especially if these other medicines also affect how well kidneys work.
Danish: Dette gælder især, hvis denne medicin har effekt på hvordan nyrerne arbejder.
English: Colics occurred very rarely in the presence of nephropathy or cholelithiasis when using high doses administered more frequently and more rapidly than recommended.
Danish: Kramper optræder meget sjældent ved tilstedeværelse af nefropati eller cholelithiae når høje doser administreres hyppigere og hurtigere end anbefalet.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Indenfor hver frekvensgruppe er bivirkninger opstillet i faldende alvorlighedsgrad.