FrancophonIA/ELRC3.0 huggingface dataset:
English: Pioglitazone Teva can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Danish: Pioglitazone Teva kan også anvendes i kombination med metformin til patienter, som ikke er tilfredsstillende kontrolleret på metformin alene, eller sammen med et sulfonylurinstof (en anden type lægemiddel mod diabetes), hvor metformin ikke er egnet (”dobbeltterapi”).
English: Why has Pioglitazone Teva been approved?
Danish: Hvorfor er Pioglitazone Teva blevet godkendt?
English: Pioglitazone Teva can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Danish: Pioglitazone Teva kan desuden anvendes sammen med både metformin og et sulfonylurinstof til patienter, som ikke er tilfredsstillende reguleret trods dobbeltterapi med orale lægemidler (“tredobbelt terapi”).
English: What is Pioglitazone Teva?
Danish: Hvad er Pioglitazone Teva?
English: How has Pioglitazone Teva been studied?
Danish: Hvordan er Pioglitazone Teva blevet undersøgt?
English: How is Pioglitazone Teva used?
Danish: Hvordan anvendes Pioglitazone Teva?
English: What is Pioglitazone Teva used for?
Danish: Hvad anvendes Pioglitazone Teva til?
English: How does Pioglitazone Teva work?
Danish: Hvordan virker Pioglitazone Teva?
English: Your doctor will decide how long you should be treated for.
Danish: Din læge vil beslutte, hvor lang tid du skal behandles.
English: This is called ‘overgrowth' or ‘superinfection'.
Danish: Det kaldes 'overvækst' eller 'superinfektion'.
English: These can develop suddenly and can potentially be life-threatening.
Danish: De kan udvikles pludseligt og være livstruende.
English: It is, therefore, unlikely that you will be given too much.
Danish: Det er derfor usandsynligt, at du vil få for meget af det.
English: • delay the natural formation of the bones of your unborn child.
Danish: • forsinke den naturlige dannelse af knoglerne hos dit ufødte barn.
English: Resistant (R >)
Danish: Resistent (R >)
English: Via Morolense, 5 03013 Ferentino (FR) Italy
Danish: Via Morolense, 5 03013 Ferentino (FR) Italien
English: Ferentino Italy
Danish: Ferentino Italien
English: Eravacycline is administered intravenously and therefore has 100% bioavailability.
Danish: Eravacyclin administreres intravenøst og har derfor en biotilgængelighed på 100 %.
English: It is, therefore, unlikely that you will miss a dose.
Danish: Det er derfor usandsynligt, at du vil glemme en dosis.
English: 1.0 mg/kg IV every 12 hours (n=6) Day 1 2125 (15) Day 10 1825 (16)
Danish: 1,0 mg/kg IV hver 12. time (n = 6) Dag 1 2125 (15) Dag 10 1825 (16)
English: No data are available for patients weighing more than 137 kg.
Danish: Der foreligger ingen data for patienter, der vejer over 137 kg.
English: This medicine should not be used in children and adolescents under the age of 18 years as it has not been studied enough in these populations.
Danish: Dette lægemiddel bør ikke bruges til børn og unge under 18 år, da det ikke er undersøgt tilstrækkeligt hos disse grupper.
English: Other appropriate measures should be taken and alternative antimicrobial treatment should be considered in accordance with existing therapeutic guidelines.
Danish: Andre relevante foranstaltninger bør træffes og en alternativ antimikrobiel behandling overvejes i henhold til de aktuelle terapeutiske retningslinjer.
English: These findings were reversible or partially reversible during recovery periods of 3- to 7-weeks.
Danish: Disse fund var reversible eller delvist reversible efter restitutionsperioder på 3-7 uger.
English: Xerava must not be mixed with other medicinal products.
Danish: Xerava må ikke blandes med andre lægemidler.
English: The safety and efficacy of Xerava in children and adolescents less than 18 years of age have not been established.
Danish: Xeravas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Xerava is not recommended for use during pregnancy as it can:
Danish: Xerava anbefales ikke under graviditet, da det kan:
English: • permanently stain your unborn child's teeth
Danish: • give varig misfarvning af dit ufødte barns tænder
English: Interactions with medicinal products that are substrates for these enzymes or transporters are therefore unlikely.
Danish: Der forventes derfor ingen interaktioner med lægemidler, der er substrater for disse enzymer eller transportere.
English: If not, it may be stored at room temperature and used within 12 hours.
Danish: Hvis du ikke får den med det samme, kan den opbevares ved stuetemperatur og anvendes inden for 12 timer.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter 'EXP'.
English: Eravacycline is not genotoxic.
Danish: Eravacyclin er ikke genotoksisk.
English: Your doctor will monitor you closely for any new infections or stop treatment with Xerava and give you another treatment if necessary.
Danish: Din læge vil overvåge dig nøje for nye infektioner eller standse behandlingen med Xerava og om nødvendigt give dig en anden behandling.
English: Name and address of the manufacturer(s) responsible for batch release Patheon Italia S.p.A.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Patheon Italia S.p.A.
English: It belongs to a group of antibiotics called ‘tetracyclines' which work by stopping the growth of certain infectious bacteria.
Danish: Det tilhører en gruppe af antibiotika, der hedder tetracycliner, som virker ved at stoppe væksten af visse smitsomme bakterier.
English: Dublin 2, D02 T380, Ireland
Danish: Dublin 2, D02 T380, Irland
English: • Allergic reaction
Danish: • allergisk reaktion
English: Environmental risk assessment studies have shown that Xerava may pose a risk for the aquatic compartment.
Danish: Miljørisikovurderingsstudier har vist, at Xerava kan udgøre en risiko for det akvatiske delmiljø.
English: Although antibiotics including Xerava fight certain bacteria, other bacteria and fungi may continue to grow.
Danish: Selvom antibiotika, herunder Xerava, slår visse bakterier ihjel, kan andre bakterier og svampe fortsat vokse.
English: This medicinal product may pose a risk to the environment (See section 5.3).
Danish: Dette lægemiddel kan udgøre en risiko for miljøet (se pkt.
English: - if you are allergic to eravacycline or any of the other ingredients of this medicine (listed in section 6).
Danish: − hvis du er allergisk over for eravacyclin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: In these cases, no recommendation on a posology can be made.
Danish: I disse tilfælde kan der ikke gives nogen dosisanbefalinger.
English: If superinfection occurs during therapy, it may require interruption of treatment.
Danish: Hvis der opstår en superinfektion under behandlingen, kan det nødvendiggøre seponering.
English: If you develop diarrhoea during or after your treatment, tell your doctor straight away.
Danish: Hvis du får diarré under eller efter behandlingen, skal du straks fortælle det til din læge.
English: In vitro data indicate that the following pathogen is not susceptible to eravacycline: • Pseudomonas aeruginosa
Danish: In vitro-data tyder på, at følgende patogen ikke er følsomt over for eravacyclin: • Pseudomonas aeruginosa
English: There are limited data on the use of eravacycline in pregnant women.
Danish: Der foreligger kun begrænsede data fra anvendelse af eravacyclin hos gravide kvinder.
English: Do not drive or use machines if you feel dizzy, light-headed or unsteady after receiving this medicine.
Danish: Du må ikke køre bil eller betjene maskiner, hvis du føler dig svimmel, ør eller ustabil efter at have fået dette lægemiddel.
English: The reconstituted and diluted solution must be administered as an intravenous infusion only.
Danish: Den rekonstituerede og fortyndede opløsning må kun administreres som intravenøs infusion.
English: A course of treatment usually lasts for 4 to 14 days.
Danish: Et behandlingsforløb varer typisk 4-14 dage.
English: Total Dose (mg)
Danish: Samlet dosis (mg)
English: Unchanged eravacycline is the major medicinal product-related component in human plasma and human urine.
Danish: Uomdannet eravacyclin er den største lægemiddelrelaterede komponent i humant plasma og human urin.
English: Xerava should not be used during pregnancy unless the clinical condition of the woman requires treatment with eravacycline.
Danish: Xerava bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver anvendelse af eravacyclin.
English: Long-term use of other similar antibiotic medicines by breast-feeding mothers can stain the child's teeth permanently.
Danish: Længere tids anvendelse af andre lignende antibiotiske lægemidler hos ammende mødre kan give varig misfarvning af børnenes tænder.
English: The exact dose needs to be calculated based on the specific patient weight.
Danish: 1 Den nøjagtige dosis skal beregnes ud fra den enkelte patients vægt.
English: Other bacterial resistance mechanisms that could potentially affect eravacycline are associated with upregulated, non-specific intrinsic multidrug-resistant (MDR) efflux.
Danish: Andre bakterielle resistensmekanismer, der potentielt kan indvirke på eravacyclin, er relateret til opreguleret, ikke-specifik intrinsisk multiresistent (MDR) efflux.
English: a Mean (range) represented b AUC of Day 1 = AUC 0-12 after the first dose and AUC for Day 10 = steady state AUC0- 12
Danish: a Gennemsnit (interval) angivet b AUC for dag 1 = AUC0-12 efter første dosis, og AUC for dag 10 = steady state-AUC0-12
English: Xerava is an antibiotic medicine that contains the active substance eravacycline.
Danish: Xerava er et antibiotisk lægemiddel, der indeholder det aktive stof eravacyclin.
English: Exposure may be increased in patients with severe hepatic impairment (Child-Pugh Class C).
Danish: Eksponeringen kan øges hos patienter med svært nedsat leverfunktion (Child-Pugh C).
English: These findings were reversible following a 70-day (10-week) recovery period, equivalent to a spermatogenic cycle in the rat.
Danish: Disse fund var reversible efter en restitutionsperiode på 70 dage (10 uger), svarende til hanrotters spermatogenesecyklus.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Officielle retningslinjer for forsvarlig brug af antibiotika bør følges.
English: Pharmacotherapeutic group: Antibacterials for systemic use, tetracyclines, ATC code: J01AA13.
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, tetracycliner, ATC-kode: J01AA13.
English: In a population pharmacokinetic analysis it was shown that eravacycline disposition (clearance and volume) was dependent on body weight.
Danish: I en farmakokinetisk populationsanalyse er det påvist, at eravacyclins disposition (clearance og volumen) afhænger af legemsvægt.
English: Medicines that induce CYP3A4 are expected to increase the rate and extent of metabolism of eravacycline.
Danish: Lægemidler, der inducerer CYP3A4, forventes at øge hastigheden og omfanget af eravacyclins metabolisering.
English: See example calculations in Table 3.
Danish: Se eksempler på beregninger i tabel 3.
English: In case of hypersensitivity reactions, treatment with eravacycline must be discontinued immediately and appropriate emergency measures must be initiated.
Danish: Hvis der opstår overfølsomhedsreaktioner, skal behandlingen med eravacyclin straks seponeres, og der skal iværksættes relevant nødbehandling.
English: In clinical trials, treatment-related diarrhoea occurred in 0.7% of patients; all cases were mild in severity.
Danish: I kliniske studier sås behandlingsrelateret diarré hos 0,7 % af patienterne, hvor alle tilfældene var lette.
English: Adverse reactions are classified according to MedDRA system organ classification and frequency.
Danish: Bivirkningerne er inddelt efter MedDRAsystemorganklasse og hyppighed.
English: Eravacycline is administered via intravenous infusion, using an infusion time of approximately 1 hour to minimise the risk of infusion-site reactions.
Danish: Eravacyclin administreres ved intravenøs infusion med en infusionstid på ca. 1 time for at minimere risikoen for reaktioner på infusionsstedet.
English: There are no human data on the effect of eravacycline on fertility.
Danish: Der foreligger ingen humane data om eravacyclins indvirkning på fertiliteten.
English: Eravacycline is also not affected by aminoglycoside inactivating or modifying enzymes.
Danish: Eravacyclin påvirkes heller ikke af aminoglykosid-inaktiverende eller -modificerende enzymer.
English: It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.
Danish: Du vil få det gennem et drop direkte ind i en blodåre (intravenøst) i løbet af ca. 1 time.
English: See example calculations in Table 1.
Danish: Se eksempler på beregninger i tabel 1.
English: Following dilution, Xerava is administered intravenously over approximately 1 hour.
Danish: Efter fortynding skal Xerava administreres intravenøst over ca. 1 time.
English: It is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to treatment with eravacycline (see section 4.8).
Danish: Det er vigtigt at tage denne diagnose i betragtning hos patienter, der får diarré under eller efter behandling med eravacyclin (se pkt.
English: Eravacycline is not a substrate for the MepA pump in Staphylococcus aureus that has been described as a resistance mechanism for tigecycline.
Danish: Eravacyclin er ikke et substrat for MepApumpen hos Staphylococcus aureus, der er beskrevet som en resistensmekanisme for tigecyclin.
English: Reconstituted and diluted solutions containing visible particles or that are cloudy in appearance should be discarded.
Danish: Rekonstitueret og fortyndet opløsning, der indeholder synlige partikler, eller som er grumset, bør bortskaffes.
English: Renal clearance and biliary and direct intestinal excretion account for approximately 35% and 48% of total body clearance after administration of a single IV dose of 60 mg 14C-eravacycline, respectively.
Danish: Nyreclearance og biliær/direkte intestinal udskillelse står for hhv. ca. 35 % og 48 % af den totale clearance efter administration af en enkelt IV-dosis på 60 mg 14C-eravacyclin.
English: Carcinogenicity studies with eravacycline have not been conducted.
Danish: Der er ikke udført karcinogenicitetsstudier med eravacyclin.
English: Total volume to be diluted (mL)
Danish: Samlet volumen, der skal fortyndes (ml)
English: The dose should be calculated based on the patient's weight; 1 mg/kg body weight.
Danish: Dosen bør beregnes på basis af patientens vægt (1 mg/kg legemsvægt).
English: TP-6208 and TP-498 are not considered to be pharmacologically active.
Danish: TP-6208 og TP-498 anses ikke for at være farmakologisk aktive.
English: The area under the plasma concentration-time curve (AUC) divided by the minimum inhibitory concentration (MIC) of eravacycline has been shown to be the best predictor of efficacy in vitro, utilising human steady state exposures in a chemostat and confirmed in vivo in animal models of infection.
Danish: Det er påvist, at arealet under plasmakoncentration-tid-kurven (AUC) divideret med MIC-værdien (mindste hæmmende koncentration) for eravacyclin er den bedste prediktor for effekt in vitro ved brug af humane steady state-eksponeringer i en kemostat og bekræftet in vivo i infektionsmodeller hos dyr.
English: - if you are allergic to any tetracycline antibiotics (e.g., minocycline and doxycycline) because you may also be allergic to eravacycline.
Danish: − hvis du er allergisk over for tetracyclin-holdige antibiotika (f.eks. minocyclin og doxycyclin), fordi du så også kan være allergisk over for eravacyclin.
English: Severe pain in the abdomen and back with fever may be signs of inflammation of the pancreas.
Danish: Kraftige smerter i maven og ryggen med feber kan være tegn på betændelse i bugspytkirtlen.
English: In such circumstances, the discontinuation of eravacycline and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered.
Danish: I disse tilfælde bør seponering af eravacyclin, understøttende behandling samt specifik behandling for Clostridium difficile overvejes.
English: Aspartate aminotransferase (AST) increased Alanine aminotransferase (ALT) increased Hyperbilirubinaemia
Danish: Forhøjet aspartataminotransferase (ASAT) Forhøjet alaninaminotransferase (ALAT) Hyperbilirubinæmi
English: The mean (%CV) volume of distribution at steady-state in healthy normal volunteers following 1 mg/kg every 12h is approximately 321 L (6.35), which is greater than total body water.
Danish: Det gennemsnitlige (% CV) fordelingsvolumen ved steady state hos raske, normale forsøgspersoner efter 1 mg/kg hver 12. time er ca. 321 l (6,35), hvilket er mere end den samlede kropsvæske.
English: What you need to know before you are given Xerava You must not receive Xerava:
Danish: Det skal du vide, før du får Xerava Du må ikke få Xerava:
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for eravacycline are:
Danish: De MIC-grænseværdier (mindste hæmmende koncentration), der er defineret for eravacyclin af EUCAST-komitéen (European Committee on Antimicrobial Susceptibility Testing), er:
English: The Cmax and AUC of eravacycline in healthy adults increase approximately in proportion to an increase in dose.
Danish: Cmax og AUC for eravacyclin hos raske voksne øges omtrent proportionalt med stigningen i dosis.
English: Prolonged use may result in the overgrowth of non-susceptible micro-organisms, including fungi.
Danish: Længere tids brug kan føre til kraftig vækst af ikke-følsomme mikroorganismer, herunder svampe.
English: - The active substance is eravacycline.
Danish: - Aktivt stof: eravacyclin.
English: Strong CYP3A4 inducers
Danish: Potente CYP3A4-inducere
English: These include sensitivity to light, headaches, vision problems, or abnormal blood tests.
Danish: Disse omfatter lysfølsomhed, hovedpine, synsforstyrrelser og unormale blodprøver.
English: There is no target-based cross-resistance between eravacycline and other classes of antibiotics such as quinolones, penicillins, cephalosporins, and carbapenems.
Danish: Der er ingen target-baseret krydsresistens mellem eravacyclin og andre klasser af antibiotika som f.eks. quinoloner, penicilliner, cephalosporiner og carbapenemer.
English: Package leaflet: Information for the patient Xerava 50 mg powder for concentrate for solution for infusion eravacycline This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Xerava 50 mg pulver til koncentrat til infusionsvæske, opløsning eravacyclin Dette lægemiddel er underlagt supplerende overvågning.
English: • Inflammation and pain caused by blood clots at the injection site (thrombophlebitis)
Danish: • betændelse og smerter forårsaget af blodpropper på injektionsstedet (tromboflebitis)
English: In case of serious reactions, eravacycline should be discontinued until a new intravenous access site is established.
Danish: Ved alvorlige reaktioner skal eravacyclin seponeres, indtil der er etableret et nyt indgivelsessted til intravenøs infusion.
English: In studies administering up to 3 mg/kg eravacycline to healthy volunteers it has been observed that doses higher than the recommended dose lead to a higher rate of nausea and vomiting.
Danish: I studier, hvor der blev administreret op til 3 mg/kg eravacyclin til raske forsøgspersoner, blev det observeret, at højere doser end den anbefalede dosis medførte en højere forekomst af kvalme og opkastning.
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til
English: Animal studies indicate that eravacycline crosses the placenta and is found in foetal plasma.
Danish: Dyrestudier viser, at eravacyclin passerer placenta og genfindes i fosterets plasma.
English: (ng*h/mL)
Danish: (ng*t/ml)
English: In the case of suspected overdose Xerava should be discontinued and the patient monitored for adverse reactions.
Danish: Ved mistanke om overdosering bør Xerava seponeres og patienten overvåges for bivirkninger.
English: The potential influence of severe obesity on eravacycline exposure has not been studied.
Danish: Svær overvægts mulige indvirkning på eravacyclin-eksponering er ikke undersøgt.
English: The mechanism of action of eravacycline involves the disruption of bacterial protein synthesis by binding to the 30S ribosomal subunit thus preventing the incorporation of amino acid residues into elongating peptide chains.
Danish: Eravacyclins virkningsmekanisme involverer ødelæggelse af bakteriens proteinsyntese ved at binde til ribosomunderenheden 30S og dermed forhindre inkorporering af aminosyrerester i elongerende peptidkæder.
English: Eravacycline may have a minor influence on the ability to drive and use machines.
Danish: Eravacyclin kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Additional minor metabolites are formed by glucuronidation, oxidation and hydrolysis.
Danish: Der dannes desuden færre metabolitter ved glukuronidering, oxidering og hydrolyse.
English: Xerava will be given to you by a doctor or nurse.
Danish: Du vil få Xerava indgivet af en læge eller en sygeplejerske.
English: Xerava may affect your ability to drive or use machines safely.
Danish: Xerava kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Women of childbearing potential should avoid becoming pregnant while receiving eravacycline.
Danish: Kvinder i den fertile alder bør undgå graviditet, mens de får eravacyclin.
English: Talk to your doctor if you have liver problems or if you are overweight, particularly if you are also taking itraconazole (a medicine to treat fungal infections), ritonavir (a medicine used to treat viral infections) or clarithromycin (an antibiotic) as your doctor will monitor you for side effects.
Danish: Fortæl det til din læge, hvis du har leverproblemer, eller hvis du er overvægtig, især hvis du samtidig tager itraconazol (et lægemiddel til behandling af svampeinfektioner), ritonavir (et lægemiddel til behandling af virusinfektioner) eller clarithromycin (et antibiotikum), da din læge så vil overvåge dig for bivirkninger.
English: What you need to know before you are given Xerava 3.
Danish: Det skal du vide, før du får Xerava 3.
English: How you will be given Xerava 4.
Danish: Sådan vil du få Xerava 4.
English: Eravacycline (and metabolites) is excreted in the milk of lactating rats.
Danish: Eravacyclin (og metabolitter) udskilles i mælken hos diegivende rotter.
English: If pancreatitis is suspected, eravacycline should be discontinued.
Danish: Hvis der er mistanke om pankreatitis, skal eravacyclin seponeres.
English: The in vitro binding of eravacycline to human plasma proteins increases with increasing concentrations, with 79%, 86% and 90% (bound) at 0.1, 1 and10 µg/mL, respectively.
Danish: Eravacyclins binding til humane plasmaproteiner in vitro øges med stigende koncentrationer (hhv. 79 %, 86 % og 90 % ved 0,1, 1 og 10 µg/ml).
English: CYP3A4 inducers exert their effect in a time-dependent manner, and may take at least 2 weeks to reach maximal effect after introduction.
Danish: CYP3A4-inducere virker på en tidsafhængig måde, og det kan tage op til 2 uger at opnå maksimal effekt efter påbegyndelse.
English: Eravacycline is excreted in both urine and faeces.
Danish: Eravacyclin udskilles i både urin og fæces.
English: In vitro, eravacycline and its metabolites are not inhibitors or inducers of CYP enzymes or transport proteins (see section 5.2).
Danish: In vitro er eravacyclin og dets metabolitter ikke hæmmere eller inducere af CYP-enzymer eller transportproteiner (se pkt.