FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted the proposed indication “prevention of certain post-operative infections in patients undergoing contaminated or potentially contaminated surgical procedures or where the occurrence of post-operative infection could be especially serious” and the data provided to support the indication, including several published studies evaluating imipenem or imipenem/cilastatin as prophylaxis antibiotic therapy to prevent post-surgical infections as a result of colorectal surgery, appendectomy, and endoscopic sclerotherapy.
Danish: CHMP noterede sig den foreslåede indikation "forebyggelse af visse postoperative infektioner hos patienter, der gennemgår forurenede eller potentielt forurenede kirurgiske indgreb, eller når forekomsten af en postoperativ infektion kan være særlig alvorlig", og de data, der blev fremlagt til støtte for indikationen, herunder adskillige offentliggjorte undersøgelser om evaluering af imipenem eller imipenem/cilastatin som profylaktisk antibiotikabehandling til forebyggelse af postkirurgiske infektioner som følge af kolorektal kirurgi, fjernelse af blindtarm og endoskopisk skleroterapi.
English: The presented data were very scarce and imipenem/cilastatin is not considered one of the most effective agents against staphylococci and methicillin-resistant staphylococci are known to be resistant to imipenem/cilastatin.
Danish: De fremlagte data var meget begrænsede, imipenem/cilastatin anses ikke for at være et af de mest effektive midler mod stafylokokker, og methicillin-resistente stafylokokker er resistente over for imipenem/cilastatin.
English: The use of imipenem/cilastatin is not suitable for treatment of these types of infections unless the pathogen is already documented and known to be susceptible or there is a very high suspicion that the most likely pathogen(s) would be suitable for treatment.
Danish: Imipenem/cilastatin er ikke egnet til behandling af disse former for infektioner, medmindre patogenet allerede er dokumenteret og vides at være modtageligt, eller når der er en meget stor formodning om, at de mest sandsynlige patogener vil være modtagelige for behandling.
English: The CHMP noted the proposed indication “lower respiratory tract infections” but considered the indication to be non-specific and therefore no longer appropriate, according to the Guideline on Antibacterial agents.
Danish: CHMP noterede sig den foreslåede indikation "nedre luftvejsinfektioner", men fandt, at indikationen ikke var specifik og derfor ikke længere hensigtsmæssig i henhold til retningslinjen om antibakterielle midler.
English: The CHMP noted that, overall, although no high quality, double blind studies were submitted together with data from a substantial number of randomised, comparative open-labelled studies and concluded that imipenem/cilastatin appears to be suitable for the management of neutropenic patients.
Danish: CHMP bemærkede, at selv om der ikke blev fremsendt nogen dobbeltblindede undersøgelser af høj kvalitet sammen med data fra en lang række randomiserede, komparative, open-label undersøgelser, ser imipenem/cilastatin generelt ud til at være egnet til behandling af neutropeniske patienter.
English: The CHMP noted and assessed the available clinical trial and publication data showing that imipenem/cilastatin is effective and well tolerated in the treatment of “Complicated Skin and soft-tissue infections”.
Danish: CHMP noterede sig og vurderede den tilgængelige kliniske undersøgelse og publikationsdata, der dokumenterer, at imipenem/cilastatin er effektivt og tolereres godt i behandling af "komplicerede infektioner i hud og underlæggende væv".
English: 4.1.11 Mixed infections
Danish: 4.1.11 Blandede infektioner
English: “complicated intra-abdominal infections”
Danish: "komplicerede intraabdominale infektioner"
English: The MAH discussed a number of specific indications, including community acquired pneumonia (CAP), cystic fibrosis, nosocomial pneumonia or ventilator associated pneumonia.
Danish: Indehaveren af markedsføringstilladelsen drøftede en række specifikke indikationer, herunder samfundserhvervet pneumoni, cystisk fibrose, nosokomiel pneumoni eller respiratorerhvervet pneumoni.
English: Therefore, the CHMP did not consider imipenem/cilastatin to be an appropriate antibiotic for the empiric treatment of this life-threatening infection as the risk of selecting for MRSA is especially high.
Danish: CHMP fandt derfor ikke, at imipenem/cilastatin var et passende antibiotikum til empirisk behandling af denne livstruende infektion, da risikoen for udvælgelse af MRSA er særlig høj.
English: The CHMP therefore deleted this indication.
Danish: CHMP slettede derfor denne indikation.
English: “complicated urinary tract infections”
Danish: ”komplicerede urinvejsinfektioner”
English: 4.1.9 Prophylaxis
Danish: 4.1.9 Profylakse
English: The CHMP noted the proposed indication “genitourinary infections” but stated that imipenem/cilastatin should be used only in severe bacterial infections suspected or due to pathogens resistant to other beta-lactams and susceptible to imipenem/cilastatin.
Danish: CHMP noterede sig den foreslåede indikation "urogenitale infektioner", men fastslog, at imipenem/cilastatin kun bør anvendes til alvorlige bakterieinfektioner, der formodes at skyldes eller skyldes patogener, som er resistente over for andre beta-lactam-midler og modtagelige for imipenem/cilastatin.
English: The CHMP noted the proposed the indication “septicaemia” but remarked on the limited and old clinical trial data available.
Danish: CHMP noterede sig den foreslåede indikation "septikæmi", men bemærkede de begrænsede og forældede kliniske undersøgelsesdata, der foreligger.
English: 4.1.1 Intra-abdominal infections
Danish: 4.1.1 Intraabdominale infektioner
English: 4.1.3 Gynaecological infections
Danish: 4.1.3 Gynækologiske infektioner
English: The CHMP noted the proposed indication “bone and joint infections” but considered the data submitted to be insufficient.
Danish: CHMP noterede sig den foreslåede indikation "knogle- og ledinfektioner", men fandt, at de fremsendte data var utilstrækkelige.
English: The CHMP was of the opinion that in light of the present clinical and PK/PD data, a standard dose of 500 mg every 6 hours or 1g every 8 hours can be accepted, provided that a recommendation is inserted in the SPC stating that for infections suspected or proven to be due to less susceptible organisms (e.g. P. aeruginosa) and for very severe infections (e.g. in neutropenic patients with a fever), the 1000 mg q.i.d should be used.
Danish: CHMP mente, at en standarddosis på 500 mg hver 6. time eller 1 g hver 8. time kunne accepteres i lyset af de nuværende farmakokinetiske/farmakodynamiske data, forudsat at der i produktresuméet medtages en anbefaling om, at der skal anvendes en dosis på 1000 mg fire gange om dagen ved infektioner, der formodes at skyldes eller beviseligt skyldes mindre modtagelige organismer (f.eks. P. aeruginosa), og ved meget alvorlige infektioner (f.eks. hos neutropeniske patienter med feber).
English: Furthermore imipenem/cilastatin has no activity against MRSA and is therefore not considered to be an appropriate antibiotic for the empiric treatment of SSTIs caused by staphylococci since the risk of selecting for MRSA is quite high.
Danish: Desuden har imipenem/cilastatin ikke nogen virkning mod MRSA og anses derfor ikke for at være et passende antibiotikum til empirisk behandling af infektioner i hud og underliggende væv forårsaget af stafylokokker, da risikoen for udvælgelse af MRSA er ret høj.
English: The CHMP noted the proposed indication “skin and soft tissue infections” (SSTI).
Danish: CHMP noterede sig den foreslåede indikation "infektioner i hud og underliggende væv".
English: 4.1.2 Lower respiratory tract infections
Danish: 4.1.2 Nedre luftvejsinfektioner
English: The CHMP considered that the data provided by the MAH included sufficient evidence that imipenem/cilastatin is efficacious in most studies in treating complicated intra-abdominal infections including e.g., intra-abdominal abscesses, peritonitis, complicated appendicitis, gall bladder empyema.
Danish: CHMP fandt, at de af indehaveren af markedsføringstilladelsen fremsendte data var dokumentation nok for, at imipenem/cilastatin er effektivt i de fleste undersøgelser af behandling af komplicerede intraabdominale infektioner, herunder intraabdominale bylder, peritonitis, komplicerede blindtarmsbetændelser og galdebæreempyem.
English: 4.1.7 Skin and soft tissue infections
Danish: 4.1.7 Infektioner i hud og underliggende væv
English: In conclusion, based on the presented data, the CHMP considered the indication to be acceptable and adopted the following harmonised indication:
Danish: CHMP fandt på grundlag af de fremlagte data indikationen acceptabel og vedtog følgende harmoniserede indikation:
English: “complicated skin and soft-tissue infections”
Danish: "komplicerede infektioner i hud og underliggende væv"
English: In conclusion, the CHMP therefore deleted the indication.
Danish: CHMP slettede derfor indikationen.
English: Furthermore, due to the limited susceptibility of specific pathogens associated with e.g. bacterial skin and soft-tissue infections, to imipenem/cilastatin, caution should be exercised.
Danish: Desuden bør der udvises forsigtighed på grund af den begrænsede modtagelighed af specifikke patogener i tilknytning til bakterieinfektioner i hud og underliggende væv.
English: Advice to physicians was provided regarding infections suspected or proven to be due to less susceptible bacterial species (e.g. Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic patients with a fever), recommending treatment with 25 mg/kg every 6 hours.
Danish: Lægerne blev rådgivet om infektioner, der formodes at skyldes eller beviseligt skyldes mindre modtagelige bakteriearter (f.eks. Pseudomonas aeruginosa), og meget alvorlige infektioner (f.eks. hos neutropeniske patienter med feber) med en anbefaling om behandling med 25 mg/kg hver 6. time.
English: The CHMP was of the opinion that in light of the present clinical and PK/PD data, for paediatric patients ≥1 year of age, a standard dose of 15 or 25 mg/kg/dose administered every 6 hours is recommended.
Danish: CHMP mente, at en standarddosis på 15 eller 25 mg/kg/dosis indgivet hver 6. time anbefales til børn ≥1 år i lyset af de nuværende farmakokinetiske/farmakodynamiske data.
English: It is recommended that infections suspected or proven to be due to less susceptible bacterial species (such as Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic patients with a fever) should be treated with 25 mg/kg administered every 6 hours.
Danish: Det anbefales, at infektioner, der formodes at skyldes eller beviseligt skyldes mindre modtagelige bakteriearter (f.eks. Pseudomonas aeruginosa), og meget alvorlige infektioner (f.eks. hos neutropeniske patienter med feber) behandles med 25 mg/kg hver 6. time.
English: It is recommended that infections suspected or proven to be due to less susceptible bacterial species (such as Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic patients with a fever) should be treated with 1000 mg administered every 6 hours.
Danish: Det anbefales, at infektioner, der formodes at skyldes eller beviseligt skyldes mindre modtagelige bakteriearter (f.eks. Pseudomonas aeruginosa), og meget alvorlige infektioner (f.eks. hos neutropeniske patienter med feber) skal behandles med 1000 mg hver 6. time.
English: 4.1.6 Bone and joint infections
Danish: 4.1.6 Knogle- og ledinfektioner
English: 4.1.5 Genitourinary infections
Danish: 4.1.5 Urogenitale infektioner
English: c Nominal significance.
Danish: c Nominel signifikans.
English: Swing the door to the left.
Danish: Drej døren mod venstre.
English: Then, leave the door open.
Danish: Lad derefter døren være åben.
English: The recommended dose depends on the underlying condition:
Danish: Den anbefalede dosis afhænger af den underliggende tilstand:
English: There may be local guidelines for disposal.
Danish: Der kan gælde lokale retningslinjer for bortskaffelse.
English: Cumulative Incidence (%)
Danish: Kumulativ forekomst (%)
English: MedDRA system organ class (SOC)
Danish: MedDRA systemorganklasse (SOC)
English: N Injection takes about 9 minutes.
Danish: N Injektionen tager cirka 9 minutter.
English: Be very careful not to push out any medicine.
Danish: Vær meget forsigtig med ikke at trykke noget medicin ud.
English: It contains electronics that should not get wet.
Danish: De indeholder elektronik, som ikke må blive våd.
English: Choose a different site each time you give yourself an injection.
Danish: Vælg et nyt sted, hver gang du giver dig selv en injektion.
English: Component of a multi-pack, can't be sold separately.
Danish: En del af en multipakning; kan ikke sælges separat.
English: Key: OLE = open-label extension.
Danish: Nøgle: OLE = åbent forlængelsesforsøg (open-label extension).
English: Tell your healthcare provider if you are allergic to latex.
Danish: Fortæl det til sundhedspersonalet, hvis du er allergisk over for latex.
English: Therefore, close monitoring may be warranted in these patients.
Danish: Nøje monitorering af disse patienter kan derfor være berettiget.
English: • You can only press the start button once.
Danish: • Du kan kun trykke én gang på startknappen.
English: Injection is complete when:
Danish: Injektionen er færdig, når:
English: D Keep PUSHING down on the skin.
Danish: D Bliv ved med at TRYKKE ned på huden.
English: Patients at Risk
Danish: Patienter med risiko
English: Then LIFT thumb.
Danish: LØFT derefter tommelfingeren.
English: Check the expiration date.
Danish: Kontrollér udløbsdatoen.
English: Your injection could take about 15 seconds.
Danish: Injektionen kan tage cirka 15 sekunder.
English: Do not use if packaging is damaged
Danish: Brug ikke, hvis emballagen er beskadiget
English: Patient Population (N)
Danish: Patientpopulation (N)
English: Take Repatha as soon as you can after the missed dose.
Danish: Tag Repatha snarest muligt efter den glemte dosis.
English: Type BF Applied Part
Danish: Anvendt del type BF
English: 45 minutes.
Danish: 45 minutter.
English: ATC code: C10AX13
Danish: ATC-kode: C10AX13
English: No time dependent changes were observed in serum concentrations over a period of 124 weeks.
Danish: Der blev ikke observeret nogen tidsafhængige ændringer i serumkoncentrationerne i et tidsrum på 124 uger.
English: Name and address of the manufacturer of the biological active substance Immunex Rhode Island Corporation 40 Technology Way
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Immunex Rhode Island Corporation 40 Technology Way
English: Repatha has not been tested in pregnant women.
Danish: Repatha er ikke blevet afprøvet på gravide kvinder.
English: Relative humidity range is 15% to 85%.
Danish: Relativ luftfugtighed: 15 % til 85 %.
English: Warning: Do not modify the device.
Danish: Advarsel: Der må ikke laves ændringer på apparatet.
English: • It is important that you do not try to give yourself the injection unless you have received training from your healthcare provider.
Danish: • Det er vigtigt, at du ikke forsøger at give dig selv injektionen, medmindre sundhedspersonalet har undervist dig i det.
English: The patients whose sera tested positive for binding antibodies were further evaluated for neutralising antibodies and none of the patients tested positive for neutralising antibodies.
Danish: De patienter, hvis sera blev testet positive for bindende antistoffer, blev undersøgt yderligere for neutraliserende antistoffer, og ingen af patienterne blev testet positive for neutraliserende antistoffer.
English: In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
Danish: Patienten skal i tilfælde af overdosering behandles symptomatisk, og supportive foranstaltninger iværksættes efter behov.
English: Put the original package with any unused pre-filled pens back in the refrigerator.
Danish: Sæt den originale pakning med eventuelle ubrugte fyldte penne tilbage i køleskabet.
English: Contact your doctor or pharmacist immediately.
Danish: Kontakt straks din læge eller apotekspersonalet.
English: Rare: may affect up to 1 in 1,000 people • Swelling of the face, mouth, tongue, or throat (angioedema)
Danish: Sjælden: kan ramme op til 1 ud af 1.000 personer • Hævelse af ansigt, mund, tunge eller hals (angioødem)
English: Needle inside (under cover)
Danish: Kanyle indeni (under hætten)
English: A healthcare provider familiar with Repatha should be able to answer your questions.
Danish: Plejepersonale, der har kendskab til Repatha, bør kunne besvare dine spørgsmål.
English: No overall differences in safety or efficacy were observed between these patients and younger patients.
Danish: Der blev ikke observeret nogen overordnede forskelle i sikkerhed eller virkning mellem disse patienter og yngre patienter.
English: Administration of Repatha can also be performed by an individual who has been trained to administer the product.
Danish: Administration af Repatha kan også udføres af en person, der har modtaget instruktioner i administration af produktet.
English: If an error occurs, the automated mini-doser cannot be used.
Danish: Hvis der er fejl, kan det automatiske minidoseringsapparat ikke bruges.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 July 2015
Danish: Dato for første markedsføringstilladelse: 17. juli 2015
English: Evolocumab was estimated to have an effective half-life of 11 to 17 days.
Danish: Det blev estimeret, at evolocumab har en halveringstid på 11 til 17 dage.
English: Stroke (fatal/non-fatal) d
Danish: Apopleksi (fatalt/ikke-fatalt)d
English: There is no specific treatment for Repatha overdose.
Danish: Der findes ingen specifik behandling til brug ved overdosering af Repatha.
English: GRH0465 v1
Danish: GRH0534DA v1
English: The absolute bioavailability after SC dosing was determined to be 72% from pharmacokinetic models.
Danish: Den absolutte biotilgængelighed efter subkutan dosering blev ud fra farmakokinetiske modeller fastlagt til at være 72 %.
English: Check that:
Danish: Kontrollér at:
English: Repatha should not be used during pregnancy unless the clinical condition of the woman requires treatment with evolocumab.
Danish: Repatha bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med evolocumab.
English: It is not known if Repatha will harm your unborn baby.
Danish: Det vides ikke, om Repatha kan skade det ufødte barn.
English: In this case, please read the dosage instructions in the package leaflet of that particular medicine as well.
Danish: I det tilfælde skal du også læse instruktionerne til dosering i indlægssedlen til den pågældende medicin.
English: Then, contact your doctor who will tell you when you should schedule your next dose, and follow the new schedule exactly as your doctor has told you.
Danish: Kontakt derefter din læge, der vil fortælle dig, hvornår du skal tage den næste dosis, og følg derefter det nye doseringsskema nøjagtigt efter lægens anvisning.
English: Myocardial infarction (fatal/non-fatal)
Danish: Myokardieinfarkt (fatalt/ikke-fatalt)
English: Elderly patients (age ≥ 65 years) No dose adjustment is necessary in elderly patients.
Danish: Ældre patienter (≥ 65 år) Der er ikke behov for justering af dosis til ældre patienter.
English: • You may hear beeps indicating your injection has started.
Danish: • Du vil måske kunne høre bippelyde som tegn på, at injektionen er startet.
English: A total of 1,324 patients enrolled in OSLER.
Danish: I alt 1.324 patienter deltog i OSLER.
English: Do not touch the grey start button
Danish: Rør ikke ved den grå startknap
English: e Assessment of time to hospitalisation for unstable angina was ad-hoc.
Danish: e Vurdering af tid indtil hospitalsindlæggelse pga. ustabil angina blev foretaget ad hoc.
English: A total of 3,681 patients enrolled in OSLER-2.
Danish: I alt 3.681 patienter deltog i OSLER-2.
English: • Do not place the loaded automated mini-doser on your body if the red status light flashes for more than 5 seconds.
Danish: • Sæt ikke det fyldte automatiske minidoseringsapparat på kroppen, hvis den røde statuslampe blinker i mere end 5 sekunder.
English: (HMD) (combined atorvastatin groups)
Danish: (HMD) (kombinerede atorvastatingrupper)
English: Repatha is given as an injection under the skin (subcutaneous).
Danish: Repatha gives som en injektion under huden (subkutant).
English: At the end of the first year (week 52 in OSLER and week 48 in OSLER-2), patients entered the all Repatha period in which all patients received open-label Repatha for either another 4 years (OSLER) or 2 years (OSLER-2).
Danish: I slutningen af det første år (uge 52 i OSLER og uge 48 i OSLER-2) indgik patienterne i en periode kun med Repatha, hvor alle patienter fik open label behandling med Repatha i enten yderligere 4 år (OSLER) eller 2 år (OSLER-2).
English: C Gather all materials needed for your injection and then wash your hands thoroughly with soap and water.
Danish: C Saml alle de materialer, du skal bruge til injektionen, og vask dine hænder grundigt med sæbe og vand.
English: This can dry out the medicine.
Danish: Medicinen kan tørre ud.
English: • Talk with your healthcare provider about proper disposal.
Danish: • Tal med sundhedspersonalet om korrekt bortskaffelse.
English: Check that the name Repatha appears on the carton label.
Danish: Kontrollér, at navnet Repatha står på etiketten.
English: (statin intolerant)
Danish: (statinintolerant)
English: Repatha must not be administered intravenously or intramuscularly.
Danish: Repatha må ikke administreres intravenøst eller intramuskulært.
English: B Remove the air bubble / gap.
Danish: B Fjern luftbobler/lufthuller.
English: • Allergic reactions including rash
Danish: • Allergiske reaktioner herunder udslæt
English: • Feeling sick (nausea)
Danish: • Kvalme (nausea)
English: The mutagenic potential of evolocumab has not been evaluated.
Danish: Evolocumabs mutagene potentiale er ikke blevet undersøgt.
English: Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Danish: Præparatets metabolisme og eliminering forventes at følge ruterne for clearance af immunglobulin, hvilket fører til nedbrydning til små peptider og individuelle aminosyrer.
English: (treatment in the absence of a statin)
Danish: (behandling uden et statin)
English: The exposure to evolocumab was found to be approximately 40-50% lower compared to healthy subjects.
Danish: Det blev konstateret, at eksponeringen af evolocumab var cirka 40-50 % lavere end hos raske personer.
English: Window turns yellow when the injection is done
Danish: Ruden bliver gul, når injektionen er færdig
English: Population pharmacokinetic analyses suggest that no dose adjustments are necessary for age, race or gender.
Danish: Farmakokinetiske populationsanalyser tyder på, at der ikke er behov for justeringer af dosis på baggrund af alder, race eller køn.
English: Animal studies do not indicate direct or indirect effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt.
English: If you notice an air bubble/gap:
Danish: Hvis du kan se en luftboble/et lufthul:
English: In clinical studies, 0.3% of patients (48 out of 17,992 patients) treated with at least one dose of Repatha tested positive for binding antibody development.
Danish: I kliniske forsøg blev 0,3 % af patienterne (48 ud af 17.992 patienter), der blev behandlet med mindst én dosis Repatha, testet positive for udvikling af bindende antistoffer.
English: Check to see that the used plunger completely fills the medicine window, and the green solid light turns off, letting you know all medicine has been injected.
Danish: Kontrollér, at det brugte stempel fylder medicinruden helt ud, og at den grønne lampe slukkes, så du ved, at al medicin er injiceret.
English: Make sure the entire adhesive is attached to your skin.
Danish: Sørg for, at hele klæbefolien sidder fast på huden.