FrancophonIA/ELRC3.0 huggingface dataset:
English: The concentration of anidulafungin in the brain was low (brain to plasma ratio of approximately 0.2) in uninfected adult and neonatal rats after a single dose.
Danish: Koncentrationen af anidulafungin i hjernen hos uinficerede voksne og nyfødte rotter efter en enkelt dosis var lav (hjerne:plasma-ratio på ca. 0,2).
English: Each vial contains 100 mg anidulafungin.
Danish: Hvert hætteglas indeholder 100 mg anidulafungin.
English: The most common sites of infection included the peritoneal cavity (54.3%; 70 of 129), hepatobiliary tract (7.0%; 9 of 129), pleural cavity (5.4%; 7 of 129) and kidney (3.1%; 4 of 129).
Danish: De hyppigste infektionssteder inkluderede peritonealhulen (54,3 %; 70 ud af 129), lever og galdeveje (7,0 %; 9 ud af 129), pleurahulen (5,4 %; 7 ud af 129) og nyre (3,1 %; 4 ud af 129).
English: For single use only.
Danish: Kun til intravenøst brug.
English: Infusion-related adverse reactions have been reported with anidulafungin in clinical studies, including rash, pruritus, dyspnoea, bronchospasm, hypotension (common events), flushing, hot flush, and urticaria (uncommon events), summarized in Table 1 (see section 4.4).
Danish: Der er rapporteret infusionsrelaterede bivirkninger med anidulafungin i kliniske studier, herunder udslæt, pruritus (almindelig bivirkning), ansigtsrødme, hedeture, og urticaria (ikke almindelig bivirkning), som anført i skema 1 (se pkt.
English: Aseptically reconstitute each vial with 30 mL water for injections to provide a concentration of 3.33 mg/mL.
Danish: Hvert hætteglas rekonstitueres med 30 ml vand til injektionsvæsker for at opnå en koncentration på 3,33 mg/ml under aseptiske forhold.
English: If you forgot to use ECALTA
Danish: Hvis du holder op med at få ECALTA
English: The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3); the successful global response rate at the End of All Treatment was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3).
Danish: Den succesfulde globale responsrate ved afslutningen af al behandling var 8/11 (72,7 %) for anidulafungin og 3/3 (100,0 %) for caspofungin (difference -27,3, 95 % CI -80,9; 40,3).
English: C. albicans (63.8% anidulafungin, 59.3% fluconazole), followed by C. glabrata (15.7%, 25.4%), C. parapsilosis (10.2%, 13.6%) and C. tropicalis (11.8%, 9.3%) - with 20, 13 and 15 isolates of the last 3 species, respectively, in the anidulafungin group.
Danish: De hyppigste arter isoleret ved baseline var C. albicans (63,8 % anidulafungin, 59,3 % fluconazol) efterfulgt af C. glabrata (15,7 %, 25,4 %), C. parapsilosis (10,2 %, 13,6 %) og C. tropicalis (11,8 %, 9,3 %) med henholdsvis 20, 13 og 15 isolater af de 3 sidstnævnte arter i anidulafungingruppen.
English: Chemical and physical in-use stability of the infusion solution has been demonstrated for 48 hours at 25ºC.
Danish: Infusionsopløsningen er dokumenteret kemisk og fysisk stabil i 48 timer ved 25 ºC.
English: Dose Number of vials of powder
Danish: Dosis Antal hætteglas med pulver
English: Each vial of powder contains 100 mg anidulafungin.
Danish: Hvert hætteglas med pulver indeholder 100 mg anidulafungin.
English: If either particulate matter or discolouration are identified, discard the solution.
Danish: Hvis der ses partikler eller misfarvning efter yderligere fortynding, skal opløsningen kasseres.
English: Common side effects (may affect up to 1 in 10 people) are:
Danish: Almindelige bivirkninger (det sker hos op til 1 ud af 10 behandlede):
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25ºC.
Danish: Den rekonstituerede opløsning er dokumenteret kemisk og fysisk stabil i 24 timer ved 25 ºC.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsbetingelser efter rekonstitution og fortynding er anført i pkt.
English: In clinically stable patients, a switch to oral azole therapy was permitted after at least 10 days of study treatment.
Danish: Hos klinisk stabile patienter var det tilladt at skifte til oral azolbehandling efter mindst 10 dages forsøgsbehandling.
English: The reconstituted solution may be stored up to 25°C for up to 24 hours prior to further dilution.
Danish: Den rekonstituerede opløsning kan opbevares ved op til 25 ºC i op til 24 timer inden yderligere fortynding.
English: Uncommon side effects (may affect up to 1 in 100 people) are:
Danish: Ikke almindelige bivirkninger (det sker hos op til 1 ud af 100 behandlede):
English: Either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion.
Danish: Enten 9 mg/ml (0,9%) natriumchloridinfusionsvæske eller 50 mg/ml (5%) glucoseinfusionsvæske.
English: Urticaria
Danish: Pleurahule
English: Anidulafungin pharmacokinetics were examined in subjects with Child-Pugh class A, B or C hepatic insufficiency.
Danish: Anidulafungins farmakokinetik blev undersøgt hos forsøgspersoner med nedsat leverfunktion, Child-Pugh-klasse A, B eller C. Hos forsøgspersoner med alle grader af nedsat leverfunktion ses ingen stigning i anidulafunginkoncentrationen.
English: Infusion solution
Danish: Infusionsopløsning
English: - Disorder of blood clotting system - Flushing - Hot flush - Stomach pain - Hives - Pain at injection site
Danish: - Problemer med blodets størkning - Ansigtsrødme - Hedeture - Mavesmerter - Nældefeber - Smerter på injektionsstedet.
English: Rats were dosed with anidulafungin at three dose levels and anaesthetised within one hour using a combination of ketamine and xylazine.
Danish: Rotter fik anidulafungin-doser på tre dosisniveauer og anæstesi inden for 1 time.
English: Excursions for 96 hours up to 25ºC are permitted, and the powder can be returned to refrigerated storage.
Danish: Kan opbevares uden for køleskab ved 25 ºC i op til 96 timer og pulveret kan derefter sættes tilbage på køl.
English: General Disorders and Administration Site Conditions
Danish: Almene symptomer og reaktioner på administration s-stedet
English: The most common pathogens isolated from a deep tissue site at baseline were C. albicans (64.3%; 83 of 129), C. glabrata (31.0%; 40 of 129), C. tropicalis (11.6%; 15 of 129), and C. krusei (5.4%; 7 of 129).
Danish: De hyppigst isolerede patogener fra dybtliggende vævssteder ved baseline var C. albicans (64,3 %; 83 ud af 129), C. glabrata (31,0 %; 40 ud af 129), C. tropicalis (11,6 %; 15 ud af 129) og C. krusei (5,4 %; 7 ud af 129).
English: In 3 month studies, evidence of liver toxicity, including elevated enzymes and morphologic alterations, was observed in both rats and monkeys at doses 4- to 6-fold higher than the anticipated clinical therapeutic exposure.
Danish: Hos både rotter og aber, der fik 4-6 gange højere doser end den forventede kliniske terapeutiske dosis, sås tegn på levertoksicitet, herunder forhøjede enzymer og morfologisk ændring i studier af 3 måneders varighed.
English: In clinically stable patients, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin.
Danish: Hos klinisk stabile patienter var det tilladt at skifte til oral azolbehandling efter mindst 5-10 dages behandling med anidulafungin.
English: What ECALTA is and what it is used for What you need to know before you use ECALTA How to use ECALTA
Danish: Det skal du vide, før du bliver behandlet med ECALTA Sådan bruger du ECALTA
English: Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.4).
Danish: Infusionsrelaterede reaktioner er sjældne, når infusionshastigheden ikke overstiger 1,1 mg/minut (se pkt.
English: The pharmacokinetics of anidulafungin in patients with fungal infections are similar to those observed in healthy subjects based on population pharmacokinetic analyses.
Danish: Baseret på populationfarmakokinetiske analyser er anidulafungins farmakokinetik den samme hos patienter med svampeinfektioner som hos raske forsøgspersoner.
English: The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) was assessed in 35 adult neutropenic patients defined as absolute neutrophil count ≤ 500 cells/mm
Danish: Effekten af anidulafungin (200 mg intravenøs initialdosis efterfulgt af 100 mg intravenøst dagligt) blev vurderet hos 35 voksne neutropene patienter defineret som absolut neutrofiltal ≤ 500 celler/mm
English: Convulsion, headache
Danish: Kramper, hovedpine
English: ECALTA is supplied as a box containing 1 vial of 100 mg powder for concentrate for solution for infusion.
Danish: ECALTA findes i en pakning med 1 hætteglas, der indeholder 100 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Not known (frequency cannot be estimated from the available data) are:
Danish: Hyppigheden ikke kendt:
English: The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) in adult neutropenic patients (defined as absolute neutrophil count ≤ 500 cells/mm
Danish: Effekten af anidulafungin (200 mg intravenøs initialdosis efterfulgt af 100 mg intravenøst dagligt) hos voksne neutropene patienter (defineret som absolut neutrofiltal ≤ 500 celler/mm
English: Infusion-related adverse events are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.8).
Danish: Infusionsrelaterede bivirkninger er sjældne, hvis infusionshastigheden ikke overstiger 1,1 mg/minut (se pkt.
English: Table 1.
Danish: Skema 1.
English: If your original symptoms come back, tell your doctor or another healthcare professional immediately.
Danish: Fortæl det straks til lægen eller sygeplejersken, hvis dine oprindelige symptomer kommer igen.
English: Candida Species
Danish: Candida-art
English: The reconstituted solution may be stored at up to 25°C for up to 24 hours.
Danish: Den rekonstituerede opløsning kan opbevares ved op til 25 °C i op til 24 timer.
English: Activity in vivo
Danish: In vivo-aktivitet
English: Anidulafungin has shown fungicidal activity against Candida species and activity against regions of active cell growth of the hyphae of Aspergillus fumigatus.
Danish: Anidulafungin virker fungicidt over for Candida, mens det for Aspergillus' vedkommende hæmmer væksten af hyphae.
English: Immune System Disorders
Danish: Immunsystem et
English: Patients with renal and hepatic impairment
Danish: Patienter med nedsat nyre- og leverfunktion
English: For anidulafungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).
Danish: Der blev ikke set påvirkning af han- og hunrotters fertilitet i studier med anidulafungin (se pkt.
English: How to store ECALTA
Danish: Sådan vil du få ECALTA
English: 30 mL 100 mL 130 mL 1.4 mL/ min
Danish: 1,4 ml/min
English: Table of Adverse Reactions System Organ
Danish: Skema over bivirkninger Organklasse Meget almindeli
English: Tel: +44 (0)1304 616161
Danish: Pfizer Limited Tel: +44 (0)1304 616161
English: The reconstituted solution may be stored up to 25C for up to 24 hours.
Danish: Den rekonstituerede opløsning kan opbevares ved op til 25 ºC i op til 24 timer.
English: No dosage adjustment of either medicinal product is recommended when anidulafungin is co-administered with ciclosporin, voriconazole or tacrolimus, and no dosage adjustment for anidulafungin is recommended when co-administered with amphotericin B or rifampicin.
Danish: Dosisjustering er ikke nødvendig for anidulafungin, når det anvendes samtidigt med amphotericin B eller rifampicin.
English: ECALTA must be reconstituted with water for injections and subsequently diluted with ONLY sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose for infusion.
Danish: ECALTA skal rekonstitueres med vand til injektionsvæsker, og derefter må det KUN fortyndes med 9 mg/ml (0,9 %) natriumchloridinjektionsvæske eller 50 mg/ml (5 %) glucoseinfusionsvæske.
English: The compatibility of reconstituted ECALTA with intravenous substances, additives, or medicines other than 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion has not been established.
Danish: Der er ikke foretaget forligelighedsundersøgelser med andre intravenøse substanser, additiver eller lægemidler end 9 mg/ml (0,9 %) natriumchloridinfusionsvæske eller 50 mg/ml (5 %) glucoseinfusionsvæske.
English: A successful global response was defined as both clinical and microbiologic success EOIVT, End of Intravenous Treatment; EOT, End of All Treatment
Danish: Et succesfuldt globalt respons blev defineret som både klinisk og mikrobiologisk succes.
English: The contents of the vial must be reconstituted with water for injections and subsequently diluted with ONLY 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion.
Danish: Indholdet i hætteglasset skal rekonstitueres med vand til injektionsvæsker, og derefter skal det fortyndes med kun 9 mg/ml (0,9 %) natriumchloridinfusionsvæske eller 50 mg/ml (5 %) glucoseinfusionsvæske.
English: Rash, pruritus
Danish: Udslæt, pruritus Urticaria
English: Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion obtaining an anidulafungin concentration of 0.77 mg/mL.
Danish: Indholdet af det (de) rekonstituerede hætteglas overføres aseptisk til den intravenøse pose (eller flaske), der indeholder enten 9 mg/ml (0,9 %) natriumchloridinfusionsvæske eller 50 mg/ml (5%) glucoseinfusionsvæske.
English: ECALTA 100 mg powder for concentrate for solution for infusion anidulafungin
Danish: ECALTA 100 mg pulver til koncentrat til infusionsvæske, opløsning Anidulafungin
English: ECALTA 100 mg powder for concentrate for solution for infusion Anidulafungin
Danish: ECALTA 100 mg pulver til koncentrat til infusionsvæske, opløsning anidulafungin
English: Your doctor will determine the duration of your treatment and how much ECALTA you will receive each day and will monitor your response and condition.
Danish: Lægen fastlægger behandlingens varighed og daglige dosis.
English: Lot {number}
Danish: * Se pkt.
English: Specimens for fungal culture should be obtained prior to therapy.
Danish: Før behandling initieres, bør der tages prøver med henblik på svampedyrkning.
English: Your doctor may decide to monitor you - for liver function more closely if you develop liver problems during your treatment.
Danish: - hvis du udvikler leverproblemer under behandlingen.
English: Serious side effects - tell your doctor or another healthcare professional immediately should any of the following occur: - Convulsion (seizure) - Flushing - Rash, pruritis (itching) - Hot flush - Hives - Sudden contraction of the muscles around the airways resulting in wheezing or coughing - Difficulty of breathing
Danish: - Kramper (anfald) - Rødmen i ansigtet - Udslæt, kløe - Hedeturer - Nældefeber - Pludselig sammentrækning af musklerne i luftvejene, der fører til hvæsende vejrtrækning eller hoste - Vejrtrækningsbesvær
English: No dose limiting toxicity was observed in a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (3 x Upper Limit of Normal (ULN)).
Danish: I et studie med 10 raske forsøgspersoner, der fik en initialdosis på 260 mg dagligt og derefter 130 mg dagligt, sås ikke dosisbegrænsende toksicitet.
English: Infusion site pain
Danish: Smerter på infusionsstedet
English: [Justification for not including Braille accepted.]
Danish: [Fritaget fra krav om blindeskrift]
English: EXP {MM/YYYY}
Danish: Exp
English: Insufficient evidence
Danish: Leverinsufficiens
English: Increased levels of hepatic enzymes have been seen in healthy subjects and patients treated with anidulafungin.
Danish: Hos raske forsøgspersoner og patienter, der er behandlet med anidulafungin, er der set en stigning i leverenzymer.
English: - if you are given anaesthetics during your treatment with ECALTA.for signs of an allergic reaction such as itching, wheezing, blotchy skin - for signs of an infusion-related reaction which could include a rash, hives, itching, redness, - for shortness of breath/breathing difficulties, dizziness or lightheadedness
Danish: - hvis du får tegn på en allergisk reaktion såsom kløe, hvæsende vejrtrækning, skjoldet hud.
English: * See section 4.4.
Danish: 4.8, forekomme.
English: Peritoneal cavity
Danish: Peritonealhule
English: ECALTA 100 mg powder for concentrate for solution for infusion
Danish: ECALTA 100 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Abdominal pain upper
Danish: Øvre abdominalsmerter
English: Exacerbation of infusion-related reactions by co-administration of anaesthetics has been seen in a nonclinical (rat) study (see section 5.3).
Danish: I et præ-klinisk dyreforsøg med rotter er der set eksacerbation af infusionsrelaterede reaktioner ved samtidig anvendelse af anæstetika (se pkt.
English: Class
Danish: Race
English: From the date of notification of the Commission Decision
Danish: Fra datoen for kundgørelse af Kommissionens afgørelse
English: Methotrexate-containing products for oral use with at least one indication requiring once weekly dosing Each MAH should operate a risk management system to be described in a risk management plan (RMP) which shall be submitted to the relevant Competent Authorities.
Danish: Methotrexat-holdige lægemidler til oral anvendelse med mindst én indikation, der kræver indgivelse én gang ugentligt Den enkelte indehaver af markedsføringstilladelse bør have et risikostyringssystem, der skal beskrives i en risikostyringsplan (RMP), som skal indsendes til de relevante kompetente myndigheder.
English: Within 3 months after Commission decision
Danish: Senest 3 måneder efter Kommissionens afgørelse
English: All methotrexate-containing products Each MAH should implement the agreed targeted follow-up questionnaires for all medication errors resulting in overdose.
Danish: Alle methotrexat-holdige lægemidler Den enkelte indehaver af markedsføringstilladelse bør anvende de vedtagne målrettede opfølgningsspørgeskemaer for alle medicineringsfejl, der medfører overdosering.
English: Within 4 years after Commission decision
Danish: Senest 4 år efter Kommissionens afgørelse
English: The RMP should reflect the following additional risk minimisation measures to address the important identified risk of medication errors resulting in overdose: - educational material(s) for healthcare professionals developed in accordance with the key elements agreed; - the agreed patient card.
Danish: Risikostyringsplanen bør omfatte nedenstående yderligere risikominimerende foranstaltninger for at imødegå den væsentlige identificerede risiko for medicineringsfejl, der medfører overdosering: - informationsmateriale til sundhedspersoner indeholdende de vedtagne hovedpunkter - det omtalte patientkort.
English: MAHs should replace any bottle or tube used as immediate packaging by blisters.
Danish: For tabletformuleringer bør følgende foranstaltning også træffes: Indehaverne af markedsføringstilladelse bør udskifte beholdere og rør med blisterkort som indre emballage.
English: Children will start by following the same guidelines.
Danish: Børn starter med at følge de samme retningslinjer.
English: First wash your hands!
Danish: Vask først Deres hænder!
English: The potential risk for humans is unknown.
Danish: Den mulige risiko hos mennesker kendes ikke.
English: It needs to be treated at once.
Danish: Det skal behandles med det samme.
English: Your doctor will decide which is best for you.
Danish: Din læge vil beslutte hvad der er bedst for dig.
English: [units]
Danish: [enheder]
English: • At the request of the European Medicines Agency;
Danish: ● på anmodning fra Det Europæiske Lægemiddelagentur
English: - The other ingredients are:
Danish: • De øvrige indholdsstoffer er:
English: It is unlikely to be serious.
Danish: Det er sandsynligvis ikke farligt.
English: Always follow aseptic techniques.
Danish: Følg altid aseptisk teknik
English: Treatment must be started under the supervision of your doctor.
Danish: Behandling skal opstartes under supervision af din læge.
English: · Risk Management plan (RMP)
Danish: Risikostyringsplan (RMP)
English: Do not inject yourself unless you have received training.
Danish: Injicer ikke dig selv medmindre du har modtaget træning.
English: Polysorbate 20,
Danish: Polysorbat 20,
English: 8 Wash your hands with soap and water.
Danish: Vask dine hænder med sæbe og vand.
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Danish: Som for alle vækstfaktorer er der bekymring for, at epoetiner kan stimulere tumorvækst.
English: · Do not freeze.
Danish: ● Må ikke fryses.
English: Please discuss this with your doctor.
Danish: Diskuter dette med din læge.
English: This multidose preparation can be used for several patients.
Danish: Denne Flerdosis formulering kan anvendes til flere patienter.
English: · Subcutaneous administration (under the skin).
Danish: ● Subkutan administration (under huden).
English: Blood pressure monitoring
Danish: Blodtryksmonitorering
English: ESAs are not indicated for use in this patient population.
Danish: ESAs er ikke indiceret til denne patientpopulation.
English: · If needed, you may cover the injection site with a small bandage.
Danish: ● Hvis nødvendigt, kan du dække injektionsstedet med en lille bandage.
English: Depending on your individual situation a blood transfusion may be preferable.
Danish: Afhængig af din individuelle situation kan en blodtransfusion være at foretrække.
English: However, it can be interrupted at any time, if necessary.
Danish: Den kan dog blive afbrudt når som helst, hvis det er nødvendigt.
English: Other in-use storage times and conditions are the responsibility of the user.
Danish: Andre opbevaringstider og -forhold fra rekonstituering til anvendelse er brugerens ansvar.
English: The recommended treatment duration is 6 weeks.
Danish: Den anbefalede behandlingslængde er 6 uger.
English: This can be treated by your doctor.
Danish: Det kan behandles af lægen.
English: It can, however, be interrupted, if necessary, at any time.
Danish: Den kan dog om nødvendigt afbrydes på ethvert tidspunkt.
English: Write the date of reconstitution and expiry on the label (expiry is 1 month after reconstitution).
Danish: Skriv dato for rekonstitution og udløb på etiketten (udløber 1 måned efter rekonstitution).
English: · In case of skin contact with medicine, wash the area that touched the medicine with water.
Danish: ● I tilfælde af, at huden kommer i kontakt med medicinen, så vask området, som rørte medicinen, med vand.
English: · If you do not hear a click, look to see that the needle is fully covered by the safety shield.
Danish: ● Hvis ikke du hører et klik, så se efter om nålen er fuldt dækket af beskyttelseshylstret.
English: Date of the last renewal: 16 July 2007
Danish: Dato for første tilladelse: 16 juli 1997 Dato for sidste fornyelse: 16 juli 2007
English: During the entire treatment period, a PCV of 48 % should not be exceeded.
Danish: Igennem hele behandlingsperioden må man ikke overskride en hæmatokrit på 48 %.
English: PRCA in patients with Hepatitis C
Danish: PRCA hos patienter med hepatitis C
English: Appropriate dose titration should be considered.
Danish: Passende dosistitrering bør overvejes.
English: Analogous results have been found in animal experiments in uraemic and normal rats.
Danish: Tilsvarende resultater er blevet fundet i dyreeksperimenter hos uræmiske og normale rotter.
English: · Choose a different injection site for each new injection.
Danish: ● Vælg et forskelligt injektionssted for hver ny injektion.
English: Leaving the reconstituted solution outside the refrigerator should be limited to the time necessary for preparing the injections.
Danish: Opbevaring af den rekonstituerede opløsning uden for køleskabet bør begrænses til den tid, der er nødvendig for at forberede injektionen.
English: Poorly controlled hypertension.
Danish: Dårligt reguleret hypertension.