FrancophonIA/ELRC3.0 huggingface dataset:
English: Busilvex must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Danish: Busilvex må ikke overføres til en infusionspose, som ikke indeholder 9 mg/ml (0,9 %) isotonisk natriumchloridinjektionsvæske eller 5 % isotonisk glucoseinjektionsvæske.
English: Therefore, men treated with Busilvex are advised not to father a child during and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Busilvex.
Danish: Busulfan kan nedsætte fertiliteten, og det anbefales derfor, at mænd rådgives om nedfrysning af sæd før behandlingen på grund af muligheden for irreversibel infertilitet forårsaget af Busilvex.
English: DMA decreases fertility in male and female rodents (see sections 4.6 and 5.3).
Danish: DMA nedsætter fertiliteten hos gnavere af begge køn (se pkt.
English: Veno occlusive liver disease
Danish: Venookklusiv leversygdom
English: Busilvex in combination with cyclophosphamide or melphalan
Danish: Busilvex i kombination med cyclophosphamid eller melphalan
English: Cardiac: clotting of femoral artery, extra heart beats, decrease in heart rate, diffuse leak of fluid from the capillaries (small blood vessels).
Danish: Hjertesymptomer: blodpropper i femoralarterien (pulsåren, der fører blodet til benene og fødderne), ekstra hjerteslag, fald i hjertefrekvensen, diffus udsivning af væske fra kapillærerne (de små blodkar).
English: To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%) Preparation of the solution for infusion
Danish: Til tilberedning af den endelige infusionsopløsning tilsættes (A) ml Busilvex til (B) ml infusionsvæske (9 mg/ml (0,9 %) isotonisk natriumchloridinjektionsvæske eller 5 % isotonisk glucoseinjektionsvæske):
English: Calculation of the quantity of Busilvex to be diluted and of the diluent Busilvex must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Danish: Beregning af mængden af Busilvex, der skal fortyndes, og af infusionsvæsken Busilvex skal fortyndes før brug med enten 9 mg/ml (0,9 %) isotonisk natriumchloridinjektionsvæske eller 5 % isotonisk glucoseinjektionsvæske.
English: 6 (mg/ml) Y: body weight of the patient in kg
Danish: Y: patientens legemsvægt i kg
English: Vascular disorders Hypertension Hypotension
Danish: Hypertension Hypotension Trombose Vasodilatation
English: No interaction was observed when busulfan was combined with fluconazole (antifungal agent) Published studies in adults described that ketobemidone (analgesic) might be associated with high levels of plasma busulfan.
Danish: Ifølge publicerede studier med deltagelse af voksne kan ketobemidon (analgetikum) muligvis sættes i forbindelse med høje plasmaniveauer af busulfan.
English: Hypogonadism
Danish: Hypogonadisme*
English: Gastro-intestinal: bleeding in the stomach and/or the gut.
Danish: Mavetarmsymptomer: mave- og/eller tarmblødning.
English: The recommended posology for children as detailed in section 4.2 enabled over 70% up to 90% of children ≥ 9 kg in achieving the therapeutic window (900-1500 µmol/L.minute).
Danish: 4.2, resulterede i, at over 70 % og op til 90 % af alle børn ≥ 9 kg nåede det terapeutiske vindue (fra 900 til 1.500 mikromol/l.minut).
English: Gastro-intestinal: nausea, inflammation of the mucosa of the mouth, vomiting, abdominal pain, diarrhoea, constipation, heart burn, anus discomfort, liquid in the abdomen.
Danish: Mave-tarmsymptomer: kvalme, betændelse af mundslimhinden, opkastning, mavesmerter, diarre, forstoppelse, halsbrand, ubehag ved endetarmsåbningen, væske i maven.
English: Therefore it is advised not to father child during the treatment and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility (see section 4.4).
Danish: På grund af risiko for irreversibel infertilitet tilrådes mænd endvidere at søge rådgivning vedrørende kryo-konservering af sperm forud for behandling (se pkt.
English: Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood.
Danish: Mavetarmsymptomer: betændelse af slimhinden i spiserøret, lammelse af tarmen, opkastning af blod.
English: Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Danish: Før og efter hver infusion gennemskylles den indlagte kateterslange med ca. 5 ml 9 mg/ml (0,9 %) isotonisk natriumchloridinjektionsvæske eller 5 % isotonisk glucoseinjektionsvæske.
English: GGT increased
Danish: Forhøjet GGT Vægtøgning
English: Hepatomegaly Jaundice
Danish: Hyperglykæmi
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Danish: Se indlægssedlen for opbevaringstid for det fortyndede lægemiddel
English: Menopausal symptoms and female infertility.
Danish: Symptomer på overgangsalder og ufrugtbarhed hos kvinder.
English: Tabulated summaries of adverse reactions
Danish: Sammendrag af bivirkninger i tabelform
English: Busilvex in combination with cyclophosphamide or melphalan In adults
Danish: Busilvex i kombination med cyclophosphamid eller melphalan Hos voksne
English: Skin: Skin colour disorder, redness of the skin, skin desquamation.
Danish: Hud: ændret hudfarve, rødmen, hudafskalning.
English: What Busilvex is and what it is used for What you need to know before you use Busilvex How to use Busilvex
Danish: Det skal De vide, før De begynder at bruge Busilvex Sådan skal De bruge Busilvex Bivirkninger
English: Multipack containing 8 (2 packs of 4) vials.
Danish: Multipakning indeholder 8 hætteglas (2 pakninger a 4) 6.6 Regler for bortskaffelse og anden håndtering
English: Busilvex must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Danish: Busilvex skal fortyndes før brug med enten 9 mg/ml (0,9 %) isotonisk natriumchloridinjektionsvæske eller 5 % isotonisk glucoseinjektionsvæske.
English: Dyspnoea Epistaxis Cough Hiccup
Danish: Dyspnø Epistaxis Hoste Hikke
English: if you have a liver, kidney, heart or lung problem,
Danish: De skal oplyse Deres læge: - om De har lever-, nyre-, hjerte- eller lungeproblemer.
English: Encephalopathy Cerebral haemorrhage
Danish: Krampeanfald Encefalopati Hjerneblødning
English: What Busilvex looks like and contents of the pack Busilvex consists of a concentrate for solution for infusion and is supplied in colourless glass vials, each vial containing 60 mg of busulfan.
Danish: Busilvex består af et koncentrat til infusionsopløsning og leveres i farveløse hætteglas.
English: Pericarditis
Danish: Takykardi
English: Busilvex 6 mg/ml concentrate for solution for infusion Busulfan
Danish: Busilvex 6 mg/ml koncentrat til infusionsvæske, opløsning Busulfan
English: Adequate contraceptive precautions should be used when either partner is receiving Busilvex.
Danish: Hvis den ene part i et forhold får Busilvex, skal parret anvende sikker prævention.
English: The patients received the dosing mentioned in section 4.2.
Danish: Patienterne blev behandlet med den dosering, der fremgår af pkt.
English: Seizure
Danish: Forstoppelse
English: Creatinine elevated Blood lactate dehydrogenase increased
Danish: Forhøjet laktatdehydrogenase i blodet Forhøjet urinsyre i blodet
English: Stomatitis Diarrhoea Abdominal pain Nausea
Danish: Abdominalsmerter Kvalme
English: NAME OF THE MEDICINAL PRODUCT Busilvex 6 mg/ml concentrate for solution for infusion busulfan
Danish: 1 LÆGEMIDLETS NAVN Busilvex 6 mg/ml koncentrat til infusionsvæske, opløsning
English: Renal disorder
Danish: Fortyndet opløsning:
English: Posology
Danish: PAKNING
English: Atelectasis Pleural effusion
Danish: Atelektase Pleuraeffusion
English: Headache Dizziness
Danish: Asteni Ødem Smerte
English: The recommended dose of Busilvex is 0.8 mg/kg Each infusion will last 2 hours
Danish: Den anbefalede dosis af Busilvex er 0,8 mg/kg .
English: Femoral artery thrombosis Capillary leak syndrome
Danish: Trombose i a. femoralis Systemisk vaskulært lækagesyndrom
English: Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for:
Danish: Det er påvist, at den kemiske og fysiske holdbarhed er 8 timer (inklusive infusionstid) efter fortynding med 5 % isotonisk glucoseinjektionsvæske eller med 9 mg/ml (0,9 %) isotonisk natriumchloridinjektionsvæske, hvis opbevaring sker ved 20 °C  5 C.
English: Neutropenia Thrombocytopenia Febrile neutropenia Anaemia
Danish: Febril neutropeni Anæmi
English: Skin desquamation Erythema Pigmentation disorder
Danish: Pigmenteringsdefekt
English: Cataract Corneal thinning Lens disorders
Danish: Katarakt Tyndere cornea Sygdom i øjets linse
English: Hepato-biliary disorders :
Danish: Mave-tarm-kanalen:
English: Busilvex 6 mg/ml concentrate for solution for infusion
Danish: Busilvex 6 mg/ml koncentrat til infusionsvæske, opløsning busulfan
English: Cerebral haemorrhage Encephalo-pathy
Danish: Hjerneblødning Encefalopati
English: All children engrafted.
Danish: Alle hjælpestoffer er anført under pkt.
English: busulfan.
Danish: Øsofagit
English: In addition, the small number of patients should also be taken into consideration.
Danish: Desuden bør det lave antal patienter også tages i betragtning.
English: Most of the reported cases developed after at least one week of treatment.
Danish: De fleste af de rapporterede tilfælde udvikledes efter mindst en uges behandling.
English: Instructions for use and handling (see also 3.
Danish: Instruktioner vedrørende anvendelse og håndtering (se også 3.
English: The mechanism of this interaction is still not elucidated.
Danish: Mekanismen bag denne interaktion er stadig ikke klarlagt.
English: • If you have, or previously had liver problems.
Danish: • Hvis De har eller tidligere har haft leverproblemer.
English: Attention should be paid to possible dehydration.
Danish: Der skal udvises opmærksomhed med hensyn til mulig dehydrering.
English: Your doctor will decide how long you should be treated.
Danish: Lægen vil beslutte, hvor længe De skal behandles.
English: A course of treatment usually lasts for 5 to 14 days.
Danish: En behandling varer almindeligvis 5-14 dage.
English: Interaction studies have only been performed in adults.
Danish: Der er kun udført interaktionsundersøgelser med voksne.
English: 95100 Catania (CT) Italy
Danish: 95100 Catania (CT) Italien
English: Clinical cure was assessed between 10 and 21 days after the administration of the last dose of treatment.
Danish: Klinisk helbredelse blev vurderet mellem 10 og 21 dage efter administration af den sidste behandlingsdosis.
English: Therefore, caution is advised when treating such patients.
Danish: Der tilrådes derfor forsigtighed ved behandling af sådanne patienter.
English: Orange cake or powder.
Danish: Orange masse eller pulver.
English: No specific information is available on the treatment of overdosage.
Danish: Der foreligger ingen specifikke oplysninger om behandlingen af en overdosis.
English: The causes of these findings remain unknown, but poorer efficacy and safety than the study comparators cannot be ruled out.
Danish: Årsagerne til disse fund er stadig ukendte, men dårligere effekt og sikkerhed end forsøgskomparatorerne kan ikke udelukkes.
English: These alterations were shown to be reversible after two weeks of dosing.
Danish: Disse forandringer vistes at være reversible efter to ugers dosering.
English: ADR identified post-marketing
Danish: ADR identificeret efter markedsføring
English: Pharmacokinetic parameters are summarised in the table below.
Danish: De farmakokinetiske parametre er sammenfattet i tabellen nedenfor.
English: Your doctor has prescribed Tygacil because you or your child at least 8 years old has one of the following types of serious infections:
Danish: Deres læge har ordineret Tygacil, fordi De eller Deres barn på mindst 8 år har én af følgende alvorlige infektioner:
English: In rats receiving single or multiple doses of
Danish: Hos rotter, som fik en enkelt eller flere doser af
English: AUC was estimated to be 20 % higher in females than in males.
Danish: AUC blev vurderet til at være 20% højere hos kvinder end hos mænd.
English: Renal clearance is approximately 13 % of total clearance.
Danish: Den renale clearance udgør ca. 13 % af den samlede clearance.
English: Therefore, no breakpoint for susceptibility is given.
Danish: Der er derfor ikke angivet breakpoint for følsomhed.
English: Do not use Tygacil
Danish: Brug ikke Tygacil
English: • If you are suffering from diarrhoea before you are given Tygacil.
Danish: • Hvis De lider af diaré, før De får Tygacil.
English: If this were the case, your doctor will monitor you closely.
Danish: Hvis De gør det, vil lægen undersøge Dem omhyggeligt.
English: No new or unexpected safety concerns were observed with tigecycline in these studies.
Danish: Der blev ikke observeret nye eller uventede sikkerhedsmæssige problemstillinger med tigecyclin i disse studier.
English: * single dose AUC0-∞, multiple dose AUC0-12h
Danish: * enkeltdosis-AUC0-∞, flerdosis-AUC0-12h
English: Summary of safety profile
Danish: Resumé over sikkerhedsprofil
English: Of these patients, 77.8 % had surgically-apparent peritonitis.
Danish: Af disse patienter havde 77,8 % kirurgisk synlig peritonitis.
English: Cases have been reported in patients without known risk factors for pancreatitis.
Danish: Tilfældene er set hos patienter uden kendte risikofaktorer for pankreatitis.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Danish: Grænseværdier for mindste hæmmende koncentration (MIC) fastlagt af European Committee on Antimicrobial Susceptibility Testing (EUCAST) er som følger:
English: • Complicated intra-abdominal infections (cIAI).
Danish: • Komplicerede intraabdominale infektioner (cIAI).
English: Tigecycline is administered intravenously and therefore has 100 % bioavailability.
Danish: Tigecyclin administreres intravenøst og har derfor en biotilgængelighed på 100 %.
English: Results from animal studies using
Danish: Resultater fra dyreforsøg med
English: Consequently, use in children should be restricted to those clinical situations where no alternative antibacterial therapy is available.
Danish: Anvendelse hos børn skal derfor begrænses til de kliniske situationer, hvor der ikke findes nogen alternativ antibakteriel behandling.
English: Available data does not suggest that this interaction may result in significant INR changes.
Danish: Tilgængelige data tyder ikke på, at denne interaktion kan forårsage signifikante ændringer i INR (International Normalised Ratio).
English: thrombocytopenia, increased international normalised ratio (INR)
Danish: thrombocytopeni, øget INR (international normalised ratio)
English: Store below 25C.
Danish: Opbevares ved temperaturer under 25 C.
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: Forekomsten af erhvervet resistens kan variere geografisk og tidsmæssigt for valgte arter, og lokale oplysninger om resistens er ønskelig især ved behandling af svære infektioner.
English: Tygacil must not be mixed with other medicinal products for which compatibility data are not available.
Danish: Tygacil må ikke blandes med andre lægemidler, for hvilke der ikke findes data om forligelighed.
English: The safety and efficacy of Tygacil in children under 8 years of age have not been established.
Danish: Sikkerheden og effekten af Tygacil hos børn under 8 år er ikke blevet undersøgt.
English: • In certain serious infections, your doctor may consider to use Tygacil in combination with other antibiotics.
Danish: • Ved visse alvorlige infektioner kan lægen overveje at bruge Tygacil i kombination med andre antibiotika.
English: • Although antibiotics including Tygacil fight certain bacteria, other bacteria and fungi may continue to grow.
Danish: • Selv om antibiotika, herunder Tygacil, bekæmper visse bakterier, kan andre bakterier og svampe fortsætte med at vokse.
English: Depending on the condition of your liver, your doctor may reduce the dose to avoid potential side effects.
Danish: Afhængig af leverens tilstand kan lægen eventuelt reducere dosis for at undgå mulige bivirkninger.
English: It is important that you tell your doctor if you are taking medicines to avoid an excess of blood clotting (named anticoagulants).
Danish: Det er vigtigt at fortælle det til lægen, hvis De tager medicin som hindrer for hurtig størkning af blodet (kaldet antikoagulantia).
English: It should be noted that the MIC distributions for organisms of the genera Bacteroides and Clostridium are wide and may include values in excess of 2 mg/L tigecycline.
Danish: Det skal noteres, at MIC fordelingen for organismer af arterne bakteroider og Clostridium er bred og kan inkludere værdier over 2mg/l tigecyclin.
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: Der bør i nødvendigt omfang søges ekspertråd, hvis den lokale prevalens af resistens er sådan, at anvendeligheden af stoffet ved i det mindste nogle typer infektioner er tvivlsom.
English: Patients should be closely monitored for the development of superinfection.
Danish: Patienterne skal overvåges nøje for udvikling af superinfektioner.
English: Ask your doctor for advice before breast-feeding your baby.
Danish: Spørg Deres læge, før De ammer Deres spædbarn.
English: Tygacil is only used when your doctor thinks other antibiotics are not suitable.
Danish: Tygacil anvendes kun, når Deres læge mener, at andre antibiotika er uegnede.
English: Bacteroides fragilis group†
Danish: Bacteroides fragilis gruppen†
English: This dose is given intravenously (directly into your blood stream) over a period of 30 to 60 minutes.
Danish: Denne dosis gives intravenøst (direkte ind i blodåren) over et tidsrum på 30-60 minutter.
English: Tigecycline should not be used during pregnancy unless the clinical condition of the woman requires treatment with tigecycline.
Danish: Tigecyclin må ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med tigecyclin.
English: The recovery of the total radioactivity in faeces and urine following administration of
Danish: Genfundet af total radioaktivitet i fæces og urin, efter administration af
English: Date of latest renewal: 22 February 2016.
Danish: Dato for første markedsføringstilladelse: 24. april 2006 Dato for seneste fornyelse: 22. februar 2016
English: Talk to your doctor about the need for an additional method of contraception while receiving Tygacil.
Danish: Tal med lægen om behovet for anden form for prævention, mens De får Tygacil.
English: Efficacy data above shown should be viewed with caution as concomitant antibiotics were allowed in this study.
Danish: Ovenstående effektdata skal vurderes med forbehold, da samtidig behandling med andre antibiotika var tilladt i dette studie.
English: On average, it is estimated that less than 20 % of tigecycline is metabolised before excretion.
Danish: Det vurderes, at mindre end 20% af tigecyclin i gennemsnit metaboliseres før udskillelse.
English: Do not take any diarrhoea medicine without first checking with your doctor.
Danish: De må ikke tage noget medicin mod diaré uden først at have rådført Dem med lægen.
English: Commonly Susceptible Species
Danish: Almindeligt følsomme arter
English: • If you have blockage of the bile ducts (cholestasis).
Danish: • Hvis De har en blokering af galdegangene (kolestase).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving Tygacil.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De bruger Tygacil.
English: All patients received IV tigecycline for a minimum of 3 consecutive days to a maximum of 14 consecutive days, with the option to be switched to an oral antibiotic on or after day 4.
Danish: Alle patienter fik tigecyclin intravenøst i mindst 3 dage i træk op til maksimalt 14 dage i træk, med mulighed for at skifte til et oralt antibiotikum på dag 4 eller herefter.
English: For anaerobic bacteria there is clinical evidence of efficacy in polymicrobial intra-abdominal infections, but no correlation between MIC values, PK/PD data and clinical outcome.
Danish: For anaerobe bakterier er der klinisk evidens for effekt over for polymikrobiale intra-abdominale infektioner men ingen korrelation mellem MIC værdier, PK/PD data og klinisk resultat.
English: Patients who develop superinfections, in particular nosocomial pneumonia, appear to be associated with poorer outcomes.
Danish: Patienter, som udvikler superinfektioner, især nosokomiel pneumoni, synes at have dårligere udfald.
English: AUC (ng•h/mL)*
Danish: AUC (ng•t/ml)*
English: In general, tigecycline is considered bacteriostatic.
Danish: Generelt betragtes tigecyclin som bakteriostatisk.
English: are generally less susceptible to tigecycline than other members of the Enterobacteriaceae.
Danish: er generelt mindre følsomme over for tigecyclin end andre medlemmer af Enterobacteriaceae.
English: Tygacil will be given to you by a doctor or a nurse.
Danish: De vil få Tygacil af en læge eller sygeplejerske.
English: This may impair your ability to drive or operate machinery.
Danish: Dette kan påvirke Deres evne til at køre bil eller betjene maskiner.
English: Tigecycline pharmacokinetics was investigated in two studies.
Danish: Tigecyclins farmakokinetik er undersøgt i to studier.
English: Uncommon ≥ 1/1,000 to
Danish: Ikke almindelig ≥ 1/1.000 til
English: Underlying diseases
Danish: Underliggende sygdomme
English: Tigecycline shows a polyexponential elimination from serum with a mean terminal elimination half-life after multiple doses of 42 hours although high interindividual variability exists.
Danish: Tigecyclin udviser polyeksponentiel elimination fra serum med en gennemsnitlig terminal eliminationshalveringstid efter flere doser på 42 timer, dog med stor interindividuel variation.
English: Gram-negative Aerobes Citrobacter freundii* Citrobacter koseri Escherichia coli* Klebsiella oxytoca*
Danish: Gramnegative aerobe bakterier Citrobacter freundii* Citrobacter koseri Escherichia coli* Klebsiella oxytoca*
English: In patients (including paediatrics) with severe hepatic impairment (Child Pugh C), the dose of tigecycline should be reduced by 50%.
Danish: Hos patienter (inklusive pædiatriske patienter) med svært nedsat leverfunktion (Child Pugh C) skal tigecyclin-dosis reduceres med 50 %.
English: Storage after preparation
Danish: Opbevaring efter tilberedelse
English: The total number of cSSTI and cIAI patients treated with tigecycline in Phase 3 and 4 clinical studies was 2,393.
Danish: Det samlede antal patienter med cSSTI og cIAI, som blev behandlet med tigecyclin i fase III-og IV kliniske studier, var 2.393.
English: Abdominal pain is commonly reported in children as it is in adults.
Danish: Abdominalsmerter er en almindelig rapporteret bivirkning hos børn ligesom hos voksne.
English: Abdominal pain may be indicative of pancreatitis.
Danish: Abdominalsmerter kan være tegn på pankreatitis.
English: The potential contribution of P-gp-mediated transport to the in vivo disposition of tigecycline is not known.
Danish: Det potentielle bidrag af den P-gp-medierede transport til fordelingen af tigecyclin in vivo kendes ikke.