FrancophonIA/ELRC3.0 huggingface dataset:
English: Trimethoprim 58 mg/g Sulfadiazine 288,3 mg/g horses Infections in horses caused by micro-organisms sensitive to trimethoprim + sulphonamide
Danish: Trimethoprim 58 mg/g Sulfadiazin 288,3 mg/g heste
English: The daily dose is 30 mg combined active ingredients per kg body weight.
Danish: Den daglige dosis er 30 mg kombinerede aktive stoffer pr. kg kropsvægt.
English: − Gastro-intestinal infections: 30 mg/kg/day over 2 applications of 15 mg/kg body weight/day or 1 application of 30 mg/kg/day, during minimal 5 days or until 2 days after the symptoms have disappeared.
Danish: − Gastrointestinale infektioner: 30 mg/kg/dag fordelt på to doser a 15 mg/kg kropsvægt/dag eller en dosis på
English: Trimethoprim 5.8 %w/w Sulfadiazine 28.83 %w/w horses Norodine Equine Paste is indicated in the treatment of bacterial infections In horses caused by sensitive microorganisms including: - Escherichia coli - Staphylococcus spp.
Danish: Norodine Equine Paste er indiceret til behandling af heste med bakterieinfektioner forårsaget af følsomme bakterier, herunder: - Escherichia coli - Staphylococcus spp.
English: Trimethoprim 5.78%w/w Sulfadiazine 28.89% w/w horses Treatment of bacterial infections in horses caused by sensitive microorganisms including:
Danish: Trimethoprim 5,78 % w/w Sulfadiazin 28,89 % w/w heste
English: 30mg of combined active ingredients per kg bodyweight daily.
Danish: 30 mg kombinerede aktive stoffer pr. kg kropsvægt daglig.
English: Gastrointestinal infections associated with E. Coli;
Danish: og Staphylococcus aureus, gastrointestinale infektioner i forbindelse med E. Coli, urogenitale infektioner i forbindelse med beta
English: Wound infections and abscesses associated with Streptococcus spp.
Danish: Anbefalet dosis hæmolytiske streptokokker, sårinfektioner og abscesser i forbindelse med Streptococcus spp.
English: Trimethoprim 2.6g and Sulfadiazine 13.0g horses Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e.g. infections in the airways, GItract, urogenital-tract and wound infections.
Danish: Infektioner hos heste forårsaget af mikroorganismer, der er sensitive over for trimethoprim og sulfonamid, f.eks. infektioner i luftveje, mave-tarm-kanalen, urogenitalsystemet og sår.
English: The daily dose is 30 mg of combined actives per kg bodyweight by oral administration.
Danish: Den daglige dosis er 30 mg kombinerede aktive stoffer pr. kg. kropsvægt ved oral indgivelse.
English: - wound infections and cellulitis - salmonellosis - as profylacticum for postoperative infections paste for 50 kg body weight.
Danish: - sårinfektioner og cellulitis - salmonellose - antibakteriel behandling ved operation, hvor asepsis ikke kan garanteres.
English: plunger provides sufficient paste to medicate 50 kg bodyweight.
Danish: stemplet giver tilstrækkelig pasta til behandling af 50 kg kropsvægt.
English: 25 mg sulfadiazine and 5 mg trimethoprim per kg BW per day, during max. 5 days
Danish: 25 mg sulfadiazin og 5 mg trimethoprim pr.
English: Treatment should be continued for up to 5 days or until 2 days after the symptoms have resolved.
Danish: Behandlingen skal fortsættes i op til fem dage eller indtil to dage efter, at symptomerne er forsvundet.
English: Each division on the plunger provides sufficient paste to medicate 50 kg bodyweight.
Danish: Hver enhed på stemplet giver tilstrækkelig pasta til behandling af 50 kg kropsvægt.
English: Trimethoprim 58,00 mg, sulfadiazine 288,30 mg horses Infections in horses caused by micro-organisms sensitive to trimethoprim + sulphonamide
Danish: Sulfadiazin 288,3 mg Trimethoprim 58,0 mg heste
English: Sulfadiazine 10 mg horses -- respiratory infections caused by Streptococcus spp., Staphylococcus aureus; - gastro-intestinal infections caused by E. coli;
Danish: Streptococcus spp., Staphylococcus aureus - Gastrointestinale infektioner forårsaget af E. coli - Urogenitale infektioner forårsaget af betahæmolytiske streptokokker - Sår og bylder forårsaget af Streptococcus spp., Staphylococcus aureus kg kropsvægt pr. dag i højst fem dage.
English: United
Danish: heste
English: Each syringe provides a daily dose for a 500 kg horse.
Danish: daglig dosis til en hest på 500 kg.
English: Each division the dial-a-dose plunger provides sufficient medication to treat 50 kg of body weight.
Danish: Hver enhed på stemplet med dosisindstilling giver tilstrækkelig pasta til behandling af 50 kg kropsvægt.
English: 1 g contain: Sulfadiazine 288.3 mg horses Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e.g. infections in the airways, GI
Danish: Infektioner hos heste forårsaget af mikroorganismer, der er sensitive over for trimethoprim og sulfonamid, f.eks. infektioner i luftveje, mave-tarm-kanalen,
English: Sulfadiazine 333 mg/g Trimethoprim 67 mg/g horses Bacterial infections, for instance infections in wounds, respiratory tract, GI-tract or urogenital system.
Danish: Sulfadiazin 333 mg/g Trimethoprim 67 mg/g heste
English: Trimetophrim 2.6g and Sulphadiazine 13g horses The product is indicated in the treatment of bacterial infections in horses caused by sensitive micro-organisms including:
Danish: Produktet er indiceret til behandling af heste med bakterieinfektioner forårsaget af følsomme bakterier, herunder:
English: - Infected wounds and cellulitis.
Danish: Anbefalet dosis sår, septikæmi og generelle infektioner.
English: Sulfadiazine Trimethoprim horses The product is recommended for the treatment of bacterial diseases in horses including: - Alimentary tract infections.
Danish: Produktet anbefales til behandling af bakterielle lidelser hos heste, herunder: - infektioner i spiseveje - infektioner i øvre og nedre luftveje,
English: Urogenital infections associated with beta-hemolytic streptococci;
Danish: Luftvejsinfektioner i forbindelse med Streptococcus spp.
English: Sulfadiazine 333 mg Trimethoprim 67 mg horses Bacterial infections, for instance infections in wounds, respiratory tract, GI-tract or urogenital system.
Danish: Bakterielle infektioner, f.eks. infektioner i sår, luftveje, mave-tarmkanalen eller urogenitalsystemet.
English: This is called overgrowth.
Danish: Dette kaldes overvækst.
English: The effects of this change are anticipated to be transient.
Danish: Effekten af denne ændring forventes at være forbigående.
English: Infuse over a period of 30 minutes.
Danish: Infunderes over en periode på 30 minutter.
English: Date of first authorisation: 18 April 2002 Date of latest renewal: 22 December 2011
Danish: Dato for første markedsføringstilladelse: 18. april 2002 Dato for seneste fornyelse: 22. december 2011
English: Therefore, caution should be exercised in such unusual cases.
Danish: Forsigtighed bør derfor udvises i sådanne usædvanlige tilfælde.
English: Repeated evaluation of the patient's condition is essential.
Danish: Gentagen evaluering af patientens tilstand er nødvendig.
English: frequency of acquired resistance > 50 % in some Member States.
Danish: frekvens for erhvervet resistens >50% i nogle medlemslande.
English: The EUCAST MIC breakpoints are as follows:
Danish: EUCAST MIC grænserne er som følgende:
English: Prevotella species*
Danish: Prevotella arter*
English: Similar observations have been made in the post-marketing environment.
Danish: Der er gjort lignende observationer efter markedsføring.
English: Solutions should be used within 4 hours of their removal from the refrigerator.
Danish: Opløsninger skal anvendes inden for 4 timer efter udtagning fra køleskab.
English: * Activity has been satisfactorily demonstrated in clinical studies.
Danish: *Tilfredsstillende aktivitet er påvist i kliniske studier.
English: The overall safety profile is comparable to that in adult patients.
Danish: Den samlede sikkerhedsprofil er sammenlignelig med den for voksne patienter.
English: Your doctor will monitor you for overgrowth and treat you if necessary.
Danish: Lægen vil kontrollere Dem for overvækst og behandle Dem om nødvendigt.
English: The first signs of a severe allergic reaction may include swelling of the face and/or throat.
Danish: De første tegn på en alvorlig allergisk reaktion kan indebære opsvulmen af ansigt og/eller hals.
English: If not used immediately, in use storage times are the responsibility of the user.
Danish: Hvis de ikke anvendes straks, er opbevaringstiden brugerens ansvar.
English: Your doctor has prescribed INVANZ because you or your child has one (or more) of the following types of infection:
Danish: Lægen har ordineret INVANZ, fordi De eller deres barn har en (eller flere) af følgende infektioner:
English: It is very important that you continue to receive INVANZ for as long as your doctor prescribes it.
Danish: Det er meget vigtigt, at De fortsætter med at få INVANZ, lige så længe lægen ordinerer det.
English: In Escherichia coli, affinity is strongest to PBPs 2 and 3.
Danish: I Escherichia coli er affiniteten stærkest over for PBP 2 og 3.
English: Anaerobes:
Danish: Anaerober:
English: Intravenous administration: INVANZ should be infused over a period of 30 minutes.
Danish: Intravenøs administration: INVANZ skal infunderes over en periode på 30 minutter.
English: Sub-optimal exposure
Danish: Sub-optimal eksponering
English: Package Leaflet: information for the user
Danish: Indlægsseddel: Information til brugeren
English: • Low blood sugar
Danish: • Lavt blodsukker
English: It has the ability to kill a wide range of bacteria (germs) that cause infections in various parts of the body.
Danish: Det er i stand til at dræbe en lang række bakterier, som forårsager infektion i forskellige dele af kroppen.
English: Diluted solutions should be used immediately.
Danish: Fortyndede opløsninger skal bruges straks.
English: For species considered susceptible to ertapenem, resistance was uncommon in surveillance studies in Europe.
Danish: For arter, der betragtes som modtagelige for ertapenem, var resistens usædvanlig i kontrolstudier i Europa.
English: INVANZ can be given to persons 3 months of age and older.
Danish: INVANZ kan gives til personer i alderen 3 måneder og derover.
English: Your doctor will decide how many days' treatment you need.
Danish: Lægen bestemmer, hvor mange dage behandlingen skal vare.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De får dette lægemiddel, da den indeholder vigtige oplysninger.
English: There is no target-based cross-resistance between ertapenem and these substances.
Danish: Der er ingen målbaseret krydsresistens mellem ertapenem og disse substanser.
English: Do not take any medicine to treat diarrhoea without first checking with your doctor.
Danish: Tag ikke medicin til behandling af diarré uden først at tjekke det med lægen.
English: INVANZ will always be prepared and given to you intravenously (into a vein) by a doctor or another healthcare professional.
Danish: INVANZ vil altid blive tilberedt og givet til Dem intravenøst (i en blodåre) af en læge eller andet sundhedspersonale.
English: Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data)
Danish: Almindelig (1/100 til <1/10); ikke almindelig ( 1/1.000 til <1/100); sjælden (1/10.000 til <1/1.000); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra de tilgængelige data).
English: Variations of colour within this range do not affect potency.
Danish: Farvevariationer inden for denne skala påvirker ikke styrken.
English: Prolonged use of ertapenem may result in overgrowth of non-susceptible organisms.
Danish: Længerevarende brug af ertapenem kan resultere i overvækst af ikke-følsomme organismer.
English: INVANZ has not been studied in pregnant women.
Danish: INVANZ er ikke undersøgt hos gravide kvinder.
English: This is because INVANZ can affect the way some other medicines work.
Danish: Dette skyldes, at INVANZ kan påvirke måden, anden medicin virker på.
English: This is because you may have a condition known as colitis (an inflammation of the bowel).
Danish: Dette skyldes, at De kan have en tilstand, der kaldes colitis (betændelse i tyktarmen).
English: Commonly susceptible species:
Danish: Almindeligvis følsomme arter:
English: Antibiotic-associated colitis
Danish: Antibiotika-associeret colitis
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der skal tages hensyn til officielle retningslinjer vedrørende hensigtsmæssig anvendelse af antibiotika.
English: Rare: Abortion
Danish: Sjælden: Abort
English: Bacteroides fragilis and species in the B. fragilis Group* Inherently resistant organisms:
Danish: Bacteroides fragilis og arter i B. fragilis-gruppen* Naturligt resistente organismer:
English: The total number of patients treated with ertapenem in clinical studies was 384.
Danish: Det totale antal patienter behandlet med ertapenem i kliniske studier var 384.
English: While antibiotics including INVANZ kill certain bacteria, other bacteria and fungi may continue to grow more than normal.
Danish: Da antibiotika, herunder INVANZ, dræber bakterier, kan andre bakterier og svampe fortsat vokse mere end normalt.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents.
Danish: Det er derfor vigtigt at overveje denne diagnose hos patienter debuterende med diarré efter administration af antibakterielle stoffer.
English: Do not drive or use any tools or machines until you know how you react to the medicine.
Danish: De må ikke køre bil eller betjene maskiner, før De ved, hvordan De reagerer på medicinen.
English: Therefore, ertapenem should not be used in these patients.
Danish: Derfor bør ertapenem ikke anvendes til disse patienter.
English: Uncommon: Positive Clostridium difficile toxin
Danish: Ikke almindelig: Positiv Clostridium difficile toksin
English: Clostridium species (excluding C. difficile)* Eubacterium species*
Danish: Clodistrium arter (eksklusiv C. difficile)* Eubacterium arter*
English: Treatment was discontinued due to adverse reactions in 1.3 % of patients.
Danish: Behandling blev seponeret på grund af utilsigtede reaktioner hos 1,3 % af patienterne.
English: Microbiological susceptibility
Danish: Mikrobiologisk følsomhed
English: In resistant isolates, resistance to other antibacterial agents of the carbapenem class was seen in some but not all isolates.
Danish: I resistente isolater sås resistens over for andre antibakterielle stoffer i carbapenemklassen i nogle men ikke alle isolater.
English: Rare: Allergy
Danish: Sjælden: Allergi
English: Adequate and well-controlled studies have not been performed in pregnant women.
Danish: Der er ikke udført tilstrækkelige og velkontrollerede studier med gravide kvinder.
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: Prævalensen af erhvervet resistens kan variere geografisk og med tid for udvalgte arter og lokal information vedrørende resistens anbefales, særligt i tilfælde af svære infektioner.
English: If superinfection occurs during therapy, appropriate measures should be taken.
Danish: Hvis der opstår superinfektion under behandlingen, skal der tages relevante forholdsregler.
English: Ertapenem was evaluated primarily for paediatric safety and secondarily for efficacy in randomised comparative, multicentre studies in patients 3 months to 17 years of age.
Danish: Ertapenem blev primært evalueret med henblik på pædiatrisk sikkerhed og sekundært med henblik på effekt i randomiserede, komparative multicenterstudier med patienter i alderen 3 måneder til 17 år.
English: Information from clinical studies
Danish: Information fra kliniske studier
English: However, in the event of an overdose, treatment with INVANZ should be discontinued and general supportive treatment given until renal elimination takes place.
Danish: I tilfælde af overdosering, skal behandling med INVANZ dog seponeres og der skal gives generel understøttende behandling indtil renal elimination har fundet sted.
English: Your doctor will decide whether you should use INVANZ in combination with these other medicines.
Danish: Lægen vil beslutte, om De må få INVANZ sammen med disse lægemidler.
English: Preparation for intravenous administration: INVANZ must be reconstituted and then diluted prior to administration.
Danish: Tilberedning til intravenøs administration: INVANZ skal rekonstitueres og fortyndes inden administration.
English: The usual duration of therapy with INVANZ is 3 to 14 days but may vary depending on the type and severity of infection and causative pathogen(s).
Danish: Sædvanlig varighed af behandling med INVANZ er 3 - 14 dage, som kan variere afhængigt af type og sværhedsgrad af infektionen og af kausale patogener.
English: Side effects reported (frequency not known) since the drug has been marketed are:
Danish: Bivirkninger, der er indberettet (hyppighed ikke kendt) efter lægemidlet er kommet på markedet:
English: • decreased consciousness
Danish: • Nedsat bevidsthed
English: Gender The plasma concentrations of ertapenem are comparable in men and women.
Danish: Køn Plasmakoncentrationer af ertapenem er sammenlignelig hos mænd og kvinder.
English: Ceftriaxone n/m % n/m %
Danish: Ceftriaxon n/m n/m %
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated-dose toxicity, genotoxicity and toxicity to reproduction and development.
Danish: Non-kliniske data viser ingen særlig risiko for mennesker, baseret på traditionelle studier af sikkerhed, farmakologi, toksicitet ved gentagne doser, genotoksicitet og toksicitet i forbindelse med reproduktion og udvikling.
English: In this age group your doctor will decide on the potential benefit of its use.
Danish: For denne aldersgruppe vil lægen afgøre den mulige gavn af at bruge medicinen.
English: No specific information is available on the treatment of overdose with ertapenem.
Danish: Der er ingen specifik information vedrørende behandling af overdosering med ertapenem.
English: A clinically significant interaction due to ertapenem displacing another medicinal product or another medicinal product displacing ertapenem is unlikely.
Danish: En klinisk signifikant interaktion på grund af, at ertapenem fortrænger et andet lægemiddel, eller at et andet lægemiddel fortrænger ertapenem, er usandsynlig.
English: If these symptoms occur tell your doctor straight away as you may need urgent medical treatment.
Danish: Hvis disse symptomer forekommer, skal De straks kontakte lægen, da De kan have brug for øjeblikkelig lægehjælp.
English: However, micro-organisms may exhibit resistance to more than one class of antibacterial agents when the mechanism is, or includes, impermeability to some compounds and/or an efflux pump.
Danish: Mikroorganismer kan dog udvise resistens over for mere end en klasse af antibakterielle stoffer, når mekanismen er, eller omfatter, uigennemtrængelighed for nogle sammensætninger og/eller en udstrømningspumpe.
English: The information below gives only approximate guidance on the probability as to whether the micro-organism will be susceptible to ertapenem or not.
Danish: Nedenstående information er udelukkende vejledende for sandsynligheden for om mikroorganismen er følsom over for ertapenem eller ej.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development, parturition or post-natal development.
Danish: Dyrestudier har ikke vist direkte eller indirekte skadelige virkninger med hensyn til graviditet, embryoføtal udvikling, fødselsforløb eller postnatal udvikling.
English: • Pain at the infusion site
Danish: • Smerte ved infusionssted
English: When clinically indicated, a switch to an appropriate oral antibacterial agent may be implemented if clinical improvement has been observed.
Danish: Hvis der er klinisk indikation herfor, kan skift til passende oral antibakteriel behandling initieres, såfremt klinisk forbedring er observeret.
English: Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, ATC code: J01DH03
Danish: Farmakoterapeutisk klassifikation: Antibakterielle lægemidler til systemisk brug, carbapenemer, ATCkode: J01DH03
English: Tell your doctor about any medical condition you have or have had including: - Kidney disease.
Danish: Fortæl Deres læge om alle helbredsproblemer De har eller har haft, også: - Nyresygdom.
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om tilberedning af lægemidlet før administration, se pkt.
English: There are no adequate and well-controlled studies regarding the effect of ertapenem use on fertility in men and women.
Danish: Der er ingen tilstrækkelige eller velkontrollerede studier vedrørende ertapenems virkning på fertiliteten hos mænd og kvinder.
English: INVANZ may be used for the treatment of infections in adult patients with mild to moderate renal impairment.
Danish: INVANZ kan anvendes til behandling af infektioner hos voksne patienter med let til moderat nedsat nyrefunktion.
English: Long-term studies in animals to evaluate the carcinogenic potential of ertapenem have not been performed.
Danish: Der er ikke udført langtidsstudier med dyr med henblik på at undersøge ertapenems carcinogene potentiale.
English: Shake well to dissolve.
Danish: Ryst grundigt for at opløse.
English: Gram-negative aerobes:
Danish: Gram-negative aerober:
English: The total number of patients treated with ertapenem in clinical studies was over 2,200 of which over 2,150 received a 1 g dose of ertapenem.
Danish: Det totale antal patienter behandlet med ertapenem i kliniske studier er over 2.200, ud af disse modtog mere end 2.150 en dosis på 1 g ertapenem.
English: INVANZ contains sodium
Danish: INVANZ indeholder natrium
English: 13 to 17 years
Danish: 13 - 17 år
English: Serious anaphylactic reactions require immediate emergency treatment.
Danish: Alvorlige anafylaktiske reaktioner kræver akut intervention.
English: 15 mL Type I glass vials with a grey butyl stopper and a white plastic cap on a coloured aluminium band seal.
Danish: 15 ml type I hætteglas med grå butyllukker og hvid plastichætte på en farvet aluminiumsforsegling.
English: Instructions of how to reconstitute and dilute INVANZ:
Danish: Vejledning for rekonstitution og fortynding af INVANZ:
English: Ertapenem Ticarcillin/clavulanate n/m % n/m %
Danish: Ticarcillin/clavulanat n/m n/m %
English: In vitro studies in human liver microsomes indicate that ertapenem does not inhibit metabolism mediated by any of the six major CYP isoforms: 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4.
Danish: In-vitro studier i humane levermikrosomer viser, at ertapenem ikke hæmmer metabolismen medieret af de 6 primære CYP-isoformer: 1A2, 2C9, 2C19, 2D6, 2E1 og 3A4.
English: Gram-positive aerobes:
Danish: Gram-positive aerober:
English: Certain side effects, such as dizziness and sleepiness, have been reported with INVANZ, which may affect some patients' ability to drive or operate machinery.
Danish: Der er indberettet visse bivirkninger med INVANZ, såsom svimmelhed og søvnighed, som kan påvirke nogle patienters evne til at køre bil eller betjene maskiner.
English: To provide an estimate of the pharmacokinetic data if all patients in this age group were to receive a 1 g dose, the pharmacokinetic data were calculated adjusting for a 1 g dose, assuming linearity.
Danish: For at give et estimat af de farmakokinetiske data, hvis alle patienter i denne aldersgruppe skulle have en 1 g dosis, blev de farmakokinetiske data beregnet ved justering for 1 g dosis, under forudsætning af linearitet.