FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials, the most common medicinal product-related treatment emergent adverse reactions were reversible nausea (21 %) and vomiting (13 %), which usually occurred early (on treatment days 1-2) and were generally mild or moderate in severity.
Danish: De hyppigste lægemiddelrelaterede bivirkninger, opstået under behandling, i kliniske forsøg var reversibel kvalme (21 %) og opkastning (13 %), som ofte viste sig tidligt (på 1.-2. behandlingsdag) og som generelt var lette eller moderate i sværhedsgrad.
English: If you are allergic to tetracycline class antibiotics (e.g., minocycline, doxycycline, etc.), you may be allergic to tigecycline.
Danish: Hvis De er allergisk over for antibiotika i tetracyklingruppen (f.eks. minocyklin, doxycyklin etc.), er De måske allergisk over for tigecyclin.
English: If you develop diarrhoea during or after your treatment, tell your doctor at once.
Danish: Hvis De får diaré under eller efter behandlingen med Tygacil, skal De straks kontakte lægen.
English: A dosing regimen of 1.2 mg/kg of tigecycline every 12 hours (to a maximum dose of 50 mg every 12 hours) for children aged 8 to <12 years and of 50 mg every 12 hours for adolescents aged 12 to <18 years would likely result in exposures comparable to those observed in adults treated with the approved dosing regimen.
Danish: Et dosisregime med 1,2 mg/kg tigecyclin hver 12. time (til en maksimumdosis på 50 mg hver 12. time) for børn i alderen 8 til <12 år og med 50 mg hver 12. time for unge i alderen 12 til <18 år vil sandsynligvis give eksponeringer, der er sammenlignelige med eksponeringer observeret hos voksne, der behandles efter det godkendte dosisregime.
English: During treatment with Tygacil:
Danish: Under behandling med Tygacil
English: However, since tigecycline may prolong both prothrombin time (PT) and activated partial thromboplastin time (aPTT), the relevant coagulation tests should be closely monitored when tigecycline is co-administered with anticoagulants (see section 4.4).
Danish: Men eftersom tigecyclin muligvis forlænger både protrombintiden (PT) og den aktiverede partielle tromboplastintid (aPTT), skal de relevante koagulationstest monitoreres nøje, når tigecyclin administreres samtidigt med antikoagulantia (se pkt.
English: The following active substances should not be administered simultaneously through the same Y-site as tigecycline: Amphotericin B, amphotericin B lipid complex, diazepam, esomeprazole, omeprazole and intravenous solutions that could result in an increase of pH above 7.
Danish: Følgende aktive stoffer må ikke administreres samtidigt via det samme Y-site som tigecyclin: Amfotericin B, amfotericin B lipidkompleks, diazepam, esomeprazol, omeprazol og intravenøse opløsninger, som kunne resultere i en stigning i pH til over 7.
English: No overall differences in pharmacokinetics were observed between healthy elderly subjects and younger subjects (see section 4.2).
Danish: Der blev ikke observeret nogen overordnede forskelle i farmakokinetikken mellem raske ældre forsøgspersoner og unge forsøgspersoner (se pkt.
English: In vitro studies in human liver microsomes indicate that tigecycline does not inhibit metabolism mediated by any of the following 6 cytochrome P450 (CYP) isoforms: 1A2, 2C8, 2C9, 2C19, 2D6, and 3A4 by competitive inhibition.
Danish: In-vitro studier i humane levermikrosomer indikerer, at tigecyclin ikke hæmmer metaboliseringen medieret af nogle af følgende 6 CYP- isoformer: 1A2, 2C8, 2C9, 2C19, 2D6 og 3A4 ved kompetitiv hæmning.
English: Tygacil may cause side effects such as dizziness.
Danish: Tygacil kan forårsage bivirkninger som svimmelhed.
English: • Your doctor will monitor you closely for the development of any other bacterial infections.
Danish: • Lægen vil overvåge Dem nøje for at se, om De udvikler andre infektioner.
English: • Poor or slow wound healing
Danish: • Dårlig eller langsom sårheling
English: • Tell your doctor immediately if you develop severe abdominal pain, nausea, and vomiting.
Danish: • Fortæl det straks til lægen, hvis De får stærke mavesmerter, kvalme og opkastning.
English: • Low protein levels in the blood
Danish: • Nedsat indhold af protein i blodet.
English: Cross-resistance between tigecycline and minocycline-resistant isolates among the Enterobacteriaceae due to multi-drug resistance (MDR) efflux pumps has been shown.
Danish: Der er påvist krydsresistens mellem tigecyclin og minocyklinresistente isolater blandt Enterobacteriaceae på grund af multistof-resistens-efflukspumper.
English: Metabolism and nutrition disorders hypoglycaemia, hypoproteinaemia
Danish: Metabolisme og ernæring hypoglykæmi, hypoproteinæmi
English: Results of animal studies indicate that tigecycline crosses the placenta and is found in foetal tissues.
Danish: Resultater fra dyreforsøg angiver, at tigecyclin passerer placenta og findes i føtalt væv.
English: In clinical studies in complicated skin and soft tissue infections (cSSTI), complicated intra-abdominal infections (cIAI), diabetic foot infections, nosocomial pneumonia and studies in resistant pathogens, a numerically higher mortality rate among tigecycline treated patients has been observed as compared to the comparator treatment.
Danish: I kliniske forsøg med komplicerede hud- og bløddelsinfektioner (cSSTI), komplicerede intraabdominale infektioner (cIAI), diabetiske fodinfektioner, nosokomiel pneumoni og forsøg med resistente patogener er der observeret en numerisk højere mortalitetsrate hos patienter, som fik tigecyclin, i forhold til patienter i behandling med komparator.
English: Overall, the primary route of elimination for tigecycline is biliary excretion of unchanged tigecycline.
Danish: Generelt er tigecyclins primære eliminationsvej galden til udskillelse af uændret tigecyclin.
English: How Tygacil is given in this leaflet)
Danish: Sådan får De Tygacil i denne indlægsseddel).
English: Antibiotic class effects
Danish: Bivirkninger ved antibiotikaklassen
English: The other ingredients are lactose monohydrate, hydrochloric acid, and sodium hydroxide.
Danish: Øvrige indholdsstoffer: Lactosemonohydrat, saltsyre og natriumhydroxid.
English: Limited experience is also available in treating patients with concurrent bacteraemia (5.6 %).
Danish: Der foreligger også begrænset erfaring med behandling af patienter med samtidig bakteriæmi (5,6 %).
English: A limited number of patients were enrolled with co-morbid factors such as diabetes (25.8 %), peripheral vascular disease (10.4 %), intravenous substance abuse (4.0 %), and HIVpositive infection (1.2 %).
Danish: Der blev inkluderet et begrænset antal patienter med komorbide faktorer, f.eks. diabetes (25,8 %), perifer vaskulær sygdom (10,4 %), intravenøst stofmisbrug (4,0 %) og positiv HIV-infektion (1,2 %).
English: Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening.
Danish: Der foreligger rapporter om pseudomembranøs colitis i forbindelse med næsten alle antibakterielle midler, og sygdommen kan variere i sværhedsgrad fra mild til livstruende.
English: In vitro studies using Caco-2 cells indicate that tigecycline does not inhibit digoxin flux, suggesting that tigecycline is not a P-glycoprotein (P-gp) inhibitor.
Danish: In vitro studier med Caco-2-celler indikerede, at tigecyclin ikke hæmmer digoxin-passagen, hvilket tyder på, at tigecyclin ikke er en P-glykoprotein-(P-gp-) hæmmer.
English: Tigecycline is vulnerable to chromosomally-encoded multi-drug efflux pumps of Proteeae and Pseudomonas aeruginosa.
Danish: Tigecyclin er sårbart over for kromosomalt indkodede multistof-efflukspumper for Proteeae og Pseudomonas aeruginosa.
English: Investigations elevated amylase in serum, increased blood urea nitrogen (BUN)
Danish: Undersøgelser forhøjet amylase i serum, øget urinkvælstof (BUN)
English: Nausea and vomiting are very common adverse reactions in children and adolescents (see section 4.8).
Danish: Kvalme og opkastning er meget almindelige bivirkninger hos børn og unge (se pkt.
English: • Skin rash, which may lead to severe blistering and peeling of the skin (Stevens-Johnson
Danish: • Udslæt, som kan føre til svær blæredannelse og afskalning af huden (Stevens-Johnsons syndrom)
English: Dizziness may occur and this may have an effect on driving and use of machines (see section 4.8).
Danish: Svimmelhed kan forekomme, og dette kan have indflydelse på evnen til at føre bil eller betjene maskiner (se pkt.
English: AST and ALT abnormalities in tigecycline-treated patients were reported more frequently in the post therapy period than in those in comparator-treated patients, which occurred more often on therapy.
Danish: Der blev oftere rapporteret om abnorme ASAT- og ALAT-værdier hos tigecyclin-behandlede patienter i perioden efter behandling end hos de patienter, som blev behandlet med komparator, hvilket oftere fandt sted under behandling.
English: Elderly No dosage adjustment is necessary in elderly patients (see section 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: Each vial contains lactose monohydrate.
Danish: Hvert hætteglas indeholder lactosemonohydrat.
English: Talk to your doctor or nurse before receiving Tygacil:
Danish: Kontakt lægen eller sundhedspersonalet, før De bruger Tygacil
English: The powder should be mixed in the vial with a small amount of solution.
Danish: Pulveret skal blandes i hætteglasset med en lille smule opløsning.
English: There were a limited number of patients with severe underlying disease such as immunocompromised patients, patients with APACHE II scores  15 (3.3 %), or with surgically apparent multiple intra-abdominal abscesses (11.4 %).
Danish: Et begrænset antal patienter med svær grundsygdom, f.eks. patienter med svækket immunforsvar, patienter med APACHE II-scorer > 15 (3,3 %) eller multiple intraabdominale abscesser (11,4 %), som var synlige ved kirurgisk indgreb.
English: In clinical trials in cIAI patients, impaired healing of the surgical wound has been associated with superinfection.
Danish: I kliniske forsøg med patienter med cIAI er dårlig heling af operationssår blevet forbundet med superinfektion.
English: Clearance, weight-normalised clearance, and AUC were not appreciably different among patients with different body weights, including those weighing ≥125 kg. AUC was 24 % lower in patients weighing ≥125 kg. No data is available for patients weighing 140 kg and more.
Danish: patienter med en vægt  125 kg. AUC var 24 % lavere hos patienter, der vejede  125 kg. Der findes ingen data for patienter, der vejer 140 kg og derover.
English: As it is known for tetracycline class antibiotics, tigecycline may also induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses, exposed in utero during the last half of gestation, and in children under eight years of age due to the enrichment in tissues with a high calcium turnover and formation of calcium chelate complexes (see section 4.4).
Danish: Ligesom andre antibiotika i tetracyklinklassen inducerer tigecyclin muligvis også permanente tanddefekter (misfarvning og emaljedefekter) og en forsinket ossifikation hos fostre, som eksponeres in utero i den sidste halvdel af gestationen, samt hos børn under otte år på grund af berigelsen i væv med en høj calciumomsætning og dannelsen af calcium-kelatkomplekser (se pkt.
English: Tygacil may cause foetal harm.
Danish: Tygacil forårsager muligvis fosterskader.
English: Pseudomembranous colitis may occur with most antibiotics including Tygacil.
Danish: Pseudomembranøs kolit kan opstå ved brug af de fleste antibiotika, herunder Tygacil.
English: Limited experience is also available in treating patients with concurrent bacteraemia (3.4 %).
Danish: Der foreligger også begrænset erfaring med behandling af patienter med samtidig bakteriæmi (3,4 %).
English: Consideration should be given to the use of combination antibacterial therapy whenever tigecycline is to be administered to severely ill patients with cIAI secondary to clinically apparent intestinal perforation or patients with incipient sepsis or septic shock (see section 4.8).
Danish: Det skal nøje overvejes at anvende kombinations-antibakteriel terapi, hvis tigecyclin administreres til alvorligt syge patienter med cIAI sekundært til klinisk tydelig tarmperforation eller patienter med begyndende sepsis eller septisk shock (se pkt.
English: In Phase 3 and 4 cSSTI and cIAI clinical studies, infection-related serious adverse reactions were more frequently reported for subjects treated with tigecycline (7.1 %) vs comparators (5.3 %).
Danish: I fase III- og IV- kliniske studier med patienter med cSSTI og cIAI blev der oftere rapporteret om infektionsrelaterede, alvorlige reaktioner hos forsøgspersoner, som blev behandlet med tigecyclin (7,1 %) i forhold til komparatorer (5,3 %).
English: In in vitro studies, no antagonism has been observed between tigecycline and other commonly used antibiotic classes.
Danish: Der er ikke påvist antagonisme i in-vitro forsøg mellem tigecyclin og andre almindeligt anvendte antibiotikagrupper.
English: The safety of tigecycline was also investigated in an open-label, ascending multi-dose PK study in 58 children aged 8 to 11 years with cSSTI (n=15), cIAI (n=24) or community-acquired pneumonia (n=19).
Danish: Tigecyclins sikkerhed blev også undersøgt ved stigende doser i et åbent farmakokinetisk flerdosisstudie hos 58 børn i alderen 8 til 11 år med cSSTI (n=15), cIAI (n=24) eller pneumoni erhvervet udenfor sygehus (n=19).
English: Although hepatic failure may occur in patients treated with tigecycline due to the underlying conditions or concomitant medicinal products, a possible contribution of tigecycline should be considered (see section 4.8).
Danish: Skønt leversvigt kan forekomme hos patienter behandlet med tigecyclin på grund af underliggende sygdomme eller anden samtidig medicinering, bør en mulig indvirkning af tigecyclin overvejes (se pkt.
English: Common side effects are (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger er (kan påvirke op til 1 ud af 10 personer):
English: Tigecycline is not extensively metabolised.
Danish: Tigecyclin metaboliseres ikke udtalt.
English: Prothrombin time or other suitable anticoagulation test should be used to monitor patients if tigecycline is administered with anticoagulants (see section 4.5).
Danish: Protrombintiden eller en anden passende antikoagulationstest skal bruges til at monitorere patienter, hvis der administreres tigecyclin samtidigt med antikoagulantia (se pkt.
English: Tigecycline is not removed in significant quantities by haemodialysis.
Danish: Tigecyclin fjernes ikke i signifikante mængder ved hæmodialyse.
English: The adverse reaction profile of tigecycline in these 58 subjects was generally consistent with that in adults, with the exception of nausea (48.3 %), vomiting (46.6 %) and elevated lipase in serum (6.9 %) which were seen at greater frequencies in children than in adults.
Danish: Tigecyclins bivirkningsprofil hos disse 58 forsøgspersoner var generelt i overensstemmelse med bivirkningsprofilen hos voksne med undtagelse af kvalme (48,3 %), opkastning (46,6 %) og forhøjet serumlipase(6,9 %), som sås med større hyppighed hos børn end hos voksne.
English: The effect of cholestasis in the pharmacokinetics of tigecycline has not been properly established.
Danish: Effekten af kolestase i tigecyclins farmakokinetik er ikke fuldstændigt fastlagt.
English: For single use only, any unused solution should be discarded.
Danish: Al ubrugt opløsning skal kasseres.
English: • Low platelet levels in the blood(which may lead to an increased bleeding tendency and bruising/haematoma)
Danish: • Lavt antal blodplader i blodet (hvilket kan medføre øget tendens til blødning og blå mærker/blodansamlinger).
English: Cases of liver injury with a predominantly cholestatic pattern have been reported in patients receiving tigecycline treatment, including some cases of hepatic failure with a fatal outcome.
Danish: Der har været indberetninger om leverskade med hovedsageligt kolestatisk mønster hos patienter i behandling med tigecyclin, herunder nogle tilfælde af leversvigt med fatal udgang.
English: Animal and human pharmacokinetic studies have demonstrated that tigecycline readily distributes to tissues.
Danish: Farmakokinetiske forsøg med dyr og mennesker har påvist, at tigecyclin nemt fordeles i væv.
English: What you need to know before you receive Tygacil
Danish: Det skal De vide, før De begynder at bruge Tygacil
English: 5 ml Type 1 clear glass vials fitted with grey butyl rubber stoppers and snap-off aluminium crimp seals.
Danish: 5 ml hætteglas af type 1 i klart glas med grå butylgummiprop og krympeforsegling af aluminium til afrivning.
English: In clinical trials in cIAI, the most common type of infection in tigecycline-treated patients was complicated appendicitis (50.3 %), followed by other diagnoses less commonly reported such as complicated cholecystitis (9.6 %), perforation of intestine (9.6 %), intra-abdominal abscess (8.7 %), gastric or duodenal ulcer perforation (8.3 %), peritonitis (6.2 %) and complicated diverticulitis (6.0 %).
Danish: I kliniske forsøg med cIAI var den mest almindelige infektionstype hos tigecyclin-behandledepatienter kompliceret blindtarmsbetændelse (50,3 %), efterfulgt af andre diagnoser, som ikke blev rapporteret så ofte, f.eks. kompliceret galdeblærebetændelse (9,6 %), tarmperforation (9,6 %), intraabdominale abscesser (8,7 %), ventrikelperforation eller perforation af duodenalsår (8,3 %), peritonitis (6,2 %) samt kompliceret divertikulitis (6,0 %).
English: Tygacil is not to be used in children less than 8 years of age due to the lack of data on safety and efficacy in this age group and because it may induce permanent dental defects such as staining on the developing teeth.
Danish: Børn under 8 år må ikke få Tygacil, da der mangler data om sikkerhed og virkning hos denne aldersgruppe, og fordi det kan medføre permanente skader på tænderne som f.eks. misfarvning af tænder under udvikling.
English: C-tigecycline, radioactivity was well distributed to most tissues, with the highest overall exposure observed in bone marrow, salivary glands, thyroid gland, spleen, and kidney.
Danish: C-tigecyclin, blev radioaktiviteten fordelt godt i de fleste væv, hvor den højeste overordnede eksponering blev observeret i knoglemarv, spytkirtler, skjoldbruskkirtlen, milten og nyrerne.
English: In clinical trials in cSSTI, the most common type of infection in tigecycline treated-patients was cellulitis (58.6 %), followed by major abscesses (24.9 %).
Danish: Den hyppigste infektionstype hos tigecyclin-behandlede patienter i kliniske forsøg med cSSTI var cellulitis (58,6 %), efterfulgt af svære abscesser (24,9 %).
English: If pancreatitis develops, treatment with tigecycline should be discontinued.
Danish: Hvis der udvikles pankreatitis, skal tigecyclin seponeres.
English: In an open-label, ascending multiple-dose study, 39 children aged 8 to 11 years with cIAI or cSSTI were administered tigecycline (0.75, 1, or 1.25 mg/kg).
Danish: I et åbent flerdosisstudie med stigende doser fik 39 børn i alderen 8 til 11 år med cIAI eller cSSTI administreret tigecyclin (0,75, 1 eller 1,25 mg/kg).
English: Children and adolescents (8 to 17 years of age) Tigecycline is only to be used to treat patients aged 8 years and older after consultation with a physician with appropriate experience in the management of infectious diseases.
Danish: Tigecyclin må kun anvendes til behandling af patienter på 8 år og opefter efter samråd med en læge, der har relevant erfaring med behandling af infektionssygdomme.
English: hypofibrinogenaemia
Danish: hypofibrinogenæmi
English: Powder for solution for infusion (powder for infusion).
Danish: Pulver til infusionsvæske, opløsning (pulver til infusionsvæske).
English: C-labelled material recovered in urine and faeces, but a glucuronide, an N-acetyl metabolite and a tigecycline epimer were also present.
Danish: C-tigecyclin, men en glukoronid, en N-acetylmetabolit og en tigecyclin epimer var også til stede.
English: What Tygacil looks like and contents of the pack Tygacil is supplied as a powder for solution for infusion in a vial and looks like an orange powder or cake before it is diluted.
Danish: Tygacil leveres som et pulver til infusionsopløsning i et hætteglas og ligner et orange pulver eller en orange masse, før det bliver opløst.
English: The vial should be gently swirled until the medicine is dissolved.
Danish: Hætteglasset skal skvulpes forsigtigt, indtil lægemidlet er opløst.
English: In reproduction toxicity studies, decreased foetal weights in rats and rabbits (with associated delays in ossification) and foetal loss in rabbits have been observed with tigecycline.
Danish: I reproduktions-toksicitetsstudier er der observeret reduceret føtalvægt hos rotter og kaniner (med tilhørende forsinket forbening) og føtaltab hos kaniner i forbindelse med behandling med tigecyclin.
English: • Complicated infection of the skin and soft tissues (the tissue below the skin), excluding diabetic foot infections.
Danish: • Komplicerede infektioner i hud- og bløddele (det væv, som findes under huden) med undtagelse af infektioner i fødderne hos personer med sukkersyge.
English: The single-dose pharmacokinetic disposition of tigecycline was not altered in patients with mild hepatic impairment.
Danish: Tigecyclins farmakokinetiske tilbøjelighed efter en enkelt dosis blev ikke ændret hos patienter med let nedsat leverfunktion.
English: Other medicines and Tygacil Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: In an open-label, single ascending dose PK study, the safety of tigecycline was investigated in 25 children aged 8 to 16 years who recently recovered from infections.
Danish: I et åbent farmakokinetisk enkeltdosisstudie blev tigecyclins sikkerhed undersøgt ved stigende doser hos 25 børn i alderen 8 til 16 år, som kort forinden var kommet sig efter en infektion.
English: Tigecycline did not affect mating or fertility in rats at exposures up to 4.7 times the human daily dose based on AUC.
Danish: Tigecyclin havde ingen virkning på befrugtning eller fertilitet hos rotter ved en eksponering på op til 4,7 gange den humane eksponering baseret på AUC.
English: Digoxin did not affect the pharmacokinetic profile of tigecycline.
Danish: Digoxin påvirkede ikke tigecyclins farmakokinetiske profil.
English: • Increases in liver enzymes, hyperbilirubinaemia (excess of bile pigment in the blood)
Danish: • Forhøjede levertal, hyperbilirubinæmi (unormal høj koncentration af galdefarvestof i blodet)
English: Warfarin did not affect the pharmacokinetic profile of tigecycline.
Danish: Warfarin påvirkede ikke tigecyclins farmakokinetiske profil.
English: Clinical experience in the use of tigecycline for the treatment of infections in paediatric patients aged 8 years and older is very limited (see sections 4.8 and 5.1).
Danish: Den kliniske erfaring med brug af tigecyclin til behandling af infektioner hos pædiatriske patienter i alderen 8 år og opefter er meget begrænset (se pkt.
English: Uncommon side effects are (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger er (kan påvirke op til 1 ud af 100 personer):
English: Nervous system disorders dizziness
Danish: Nervesystemet svimmelhed
English: If you develop another bacterial infection, your doctor may prescribe a different antibiotic specific for the type of infection present.
Danish: Hvis De udvikler en anden infektion, vil lægen måske ordinere et andet antibiotikum.
English: Pathogens of the family Proteeae (Proteus spp., Providencia spp., and Morganella spp.)
Danish: Patogener i Proteeae-gruppen (Proteus spp., Providencia spp.
English: Tigecycline is administered only by intravenous infusion over 30 to 60 minutes (see sections 4.4 and 6.6).
Danish: Tigecyclin administreres kun som intravenøs infusion over 30 til 60 minutter (se pkt.
English: Patients should be carefully monitored during therapy (see section 4.8).
Danish: Patienterne skal derfor monitoreres nøje under behandling (se pkt.