FrancophonIA/ELRC3.0 huggingface dataset:
English: For example, whether pneumonia was acquired in a hospital setting or not, provides additional clues to the pathogens involved and have led to definitions of hospital-acquired pneumonia (HAP) and community-acquired pneumonia (CAP).
Danish: Som eksempel kan nævnes, at det forhold, om pneumoni er erhvervet i hospitalsomgivelser eller ikke, giver supplerende fingerpeg om de involverede patogener og har ført til definitionerne af hospitalserhvervet pneumoni og samfundserhvervet pneumoni.
English: In addition the draft addendum to the Note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) refers to IAI only.
Danish: Desuden anvendes udelukkende betegnelsen intraabdominale infektioner i udkastet til et tillæg til CHMP's retningslinjer for vurdering af lægemidler til behandling af bakterielle infektioner (“Guideline on the Evaluation of Medicinal Products Indicated for the Treatment of Bacterial Infections” (CPMP/EWP/558/95 rev 2)).
English: The MAH has proposed wording for section 5.3 of the SmPC, which reflects the relevant non clinical data with Rocephin that may be informative for safe clinical use.
Danish: Til produktresuméets punkt 5.3 har indehaveren af markedsføringstilladelsen foreslået en ordlyd, som afspejler de relevante ikke-kliniske data med Rocephin, der kan være informative med henblik på sikker klinisk anvendelse.
English: • Acute exacerbations of chronic bronchitis (AECB)
Danish: • Akutte eksacerbationer af kronisk bronkitis
English: Ceftriaxone has been used as a comparator in several recently conducted clinical trials of newer antibacterial medicinal products including ceftaroline and ceftobiprole.
Danish: Ceftriaxon har været sammenligningsstof i flere nylige kliniske undersøgelser af nyere antibakterielle lægemidler, herunder ceftarolin og ceftobiprol.
English: • The committee reviewed the data submitted by the MAH from the existing clinical studies, published literature and the cumulative safety experience with Rocephin as reported on the company's drug safety database justifying the proposed harmonisation of the Product Information.
Danish: • udvalget gennemgik de data, der er forelagt af indehaveren af markedsføringstilladelsen fra eksisterende kliniske undersøgelser, og de akkumulerede sikkerhedserfaringer med Rocephin fra virksomhedens sikkerhedsdatabase, som begrunder den foreslåede harmonisering af produktinformationen,
English: The generally good tissue penetration, antibacterial activity, PK and PK/PD considerations provide scientific rationale for use of ceftriaxone in the treatment of bacterial endocarditis.
Danish: Den generelt gode vævspenetration, den antibakterielle aktivitet og de farmakokinetiske og farmakokinetiske/farmakodynamiske forhold giver videnskabeligt grundlag for et rationale for anvendelse af ceftriaxon til behandling af bakteriel endokarditis.
English: The MAH's clinical trial data all stem from open, retrospective or observational uncontrolled studies enrolling small numbers of patients.
Danish: De kliniske data fra indehaveren af markedsføringstilladelsen er alle fra åbne, retrospektive undersøgelser eller observationsundersøgelser med få patienter.
English: Therefore the revised indication ‘Ceftriaxone may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection' was proposed and considered acceptable by the CHMP.
Danish: Derfor foresloges den reviderede indikation “ceftriaxon kan anvendes til behandling af neutropene patienter med feber af formodet bakteriel årsag”, som kunne godtages af CHMP.
English: Rocephin is contraindicated in premature and in fullterm neonates at risk of developing bilirubin encephalopathy or receiving calcium-containing intravenous infusions.
Danish: Rocephin er kontraindiceret hos præmature og fuldbårne nyfødte, som har risiko for at udvikle bilirubinencefalopati eller er i behandling med calciumholdige intravenøse infusionsvæsker.
English: There is some evidence from clinical studies supporting the indication bone and joint infections.
Danish: Der er nogen evidens fra kliniske undersøgelser til støtte for indikationen infektioner i knogler og led.
English: The statement on the lack of a disulfiram- like interaction with alcohol has been deleted as there is insufficient evidence to rule it out.
Danish: Angivelsen af manglende disulfiram-lignende interaktion med alkohol er slettet, da evidensen herfor er utilstrækkelig.
English: Amendments were made to the wording for the period of lactation, mentioning the fact that the risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded and that breastfeeding might have to be discontinued due to these effects.
Danish: Der blev foretaget rettelser i ordlyden om ammeperioden med angivelse af, at risikoen for diarré og svampeinfektion af slimhinder ikke kan udelukkes, og at det kan være nødvendigt at ophøre med amning på grund af disse virkninger.
English: Infections of bones and joints
Danish: Infektioner i knogler og led
English: Current guidelines require indications to be specific where possible, as it was recognised that different clinical conditions summarised under LRTI have different etiology and therefore may require different treatment.
Danish: I henhold til nugældende retningslinjer skal indikationer om muligt være specifikke; de forskellige kliniske tilstande, der er samlet under betegnelsen nedre luftvejsinfektioner, har således forskellig ætiologi og skal derfor behandles forskelligt.
English: This section also states that ceftriaxone solutions containing lidocaine should never be administered intravenously.
Danish: Under dette punkt angives desuden, at lidocainholdige opløsninger af ceftriaxon aldrig må indgives intravenøst.
English: On balance, the CHMP considered that the indication ‘Acute exacerbations of chronic obstructive pulmonary disease' is approvable.
Danish: Alt i alt fandt CHMP, at indikationen “akutte eksacerbationer af kronisk obstruktiv lungesygdom” kan godkendes.
English: Rocephin contains ceftriaxone, a cephalosporin antibacterial agent with in-vitro activity against a range of Gram-positive and Gram-negative bacteria.
Danish: Rocephin indeholder ceftriaxon, der er et antibiotikum i gruppen af cephalosporiner med in vitroaktivitet mod en række grampositive og gramnegative bakterier.
English: Therefore, in view of the available data and the fact that ceftriaxone has been approved by the majority of member states for bone and joint infections, the CHMP agreed with harmonised indication for: infections of bones and joints.
Danish: På baggrund af de foreliggende data og af, at ceftriaxon er godkendt i størstedelen af medlemsstaterne til infektioner i knogler og led, godkendte CHMP den harmoniserede indikation: infektioner i knogler og led.
English: The most frequently reported adverse reactions for Rocephin are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and increased hepatic enzymes.
Danish: De hyppigst indberettede bivirkninger for Rocephin er eosinofili, leukopeni, trombocytopeni, diarré, udslæt og forhøjede leverenzymer.
English: Section 4.4 - Special warnings and precautions for use The information on C. difficile and antibiotic- associated colitis was re-worded in line with previous Article 30 harmonisation procedures for beta- lactams and to include hypersensitivity reactions and interactions with calcium-containing products.
Danish: Oplysningerne om C. difficile og antibiotika-associeret colitis er blevet omformuleret, så de er på linje med den tidligere artikel 30-harmoniseringsprocedure for betalactamer og medtager hypersensitivitetsreaktioner og interaktioner med calciumholdige produkter.
English: In case a lidocaine solution is used as a solvent, ceftriaxone solutions must only be used for intramuscular injection.
Danish: Hvis solvensen er en lidocainopløsning, må opløsningen af ceftriaxon kun anvendes intramuskulært.
English: Nevertheless, ceftriaxone has a place where intravenous treatment is needed.
Danish: Ceftriaxon har alligevel berettigelse, når der er behov for intravenøs behandling.
English: Considering the submitted data, the CHMP was of the view that ceftriaxone is useful in the treatment of syphilis.
Danish: På baggrund af de forelagte data var CHMP af den opfattelse, at ceftriaxon er nyttigt til behandling af syfilis.
English: The CHMP considered that there was insufficient data to justify the disease subsets of gonococcal arthritis and gonococcal eye infection as separate indications, and therefore these were deleted as specific indications in the SmPC.
Danish: CHMP fandt dataene utilstrækkelige til at berettige underkategorierne gonokok-artritis og gonokokøjeninfektioner, der derfor blev slettet som selvstændige indikationer i produktresuméet.
English: For the preparation of the harmonised product information, the MAH considered the current registered SmPCs of all EU Member States with an active registration, the published literature and the cumulative safety experience with Rocephin as reported in the company's drug safety database and reflected in the appropriate sections of the company's Core Data Sheet (CDS).
Danish: Ved udarbejdelsen af de harmoniserede produktoplysninger tog indehaveren af markedsføringstilladelsen udgangspunkt i de aktuelt registrerede produktresuméer i alle de EUmedlemsstater, hvor der er en aktiv registrering, den publicerede litteratur og de akkumulerede sikkerhedserfaringer med Rocephin, således som disse er registreret i de pågældende afsnit af virksomhedens centrale datablad.
English: Overall, the CHMP considered that the evidence for the use of ceftriaxone in HAP was sufficient for accepting the harmonised indication taking into account that HAP is included in the indications LRTI or ‘pneumonia', which are currently licensed in the majority of member states.
Danish: Overordnet fandt CHMP, at evidensen for anvendelse af ceftriaxon ved hospitalserhvervet pneumoni var tilstrækkelig til godkendelse af den harmoniserede indikation, når det tages i betragtning, at hospitalserhvervet pneumoni indgår i indikationerne nedre luftvejsinfektioner eller “pneumoni”, som aktuelt er godkendt i størstedelen af medlemsstaterne.
English: Section 4.6 - Fertility, pregnancy and lactation The pregnancy statements suggest that there is limited human experience, that animal studies do not indicate an embryotoxic or teratogenic effect, and that caution should be exercised if using during pregnancy.
Danish: Anvisningerne for graviditet nævner, at erfaringer hos mennesker er begrænsede, at dyreundersøgelser ikke tyder på embryotoksisk eller teratogen virkning, og at der bør udvises forsigtighed ved anvendelse under graviditet.
English: Adverse events such biliary lithiasis, biliary stasis and renal lithiasis have also been included with a cross reference to section 4.8 (undesirable effects).
Danish: Bivirkninger såsom cholelithiasis, kolestase og nyresten er ligeledes medtaget med en krydshenvisning til punkt 4.8 (bivirkninger).
English: Therefore the CHMP limited the indication to complicated UTI (cUTI), including pyelonephritis.
Danish: CHMP begrænsede derfor indikationen til komplicerede urinvejsinfektioner, herunder pyelonefritis.
English: There is evidence for the efficacy of ceftriaxone in the perioperative prophylaxis of infections in several types of surgery such as cardiac surgery, orthopaedic surgery, genitourinary surgery and transurethral resection of the prostate (TURP).
Danish: Der er evidens for virkningen af ceftriaxon til perioperativ profylakse af infektioner ved en række forskellige typer operationer såsom hjerteoperationer, ortopædiske operationer, urogenitale operationer og transuretral prostatektomi.
English: The MAH has provided studies indicating that the pharmacokinetics of ceftriaxoneare not significantly altered in patients with renal and hepatic impairment, both of which may complicate acute infections.
Danish: Indehaveren af markedsføringstilladelsen har forelagt undersøgelser, der viser, at farmakokinetikken af ceftriaxon ikke afviger væsentligt hos patienter med nedsat nyre- eller leverfunktion, der begge kan være komplikationer ved akutte infektioner.
English: The MAH has provided data to demonstrate that doses of up to 700 mg/kg of ceftriaxone had no significant effect on fertility or embryofoetal development and the studies conducted are considered adequate.
Danish: Indehaveren af markedsføringstilladelsen har forelagt data, der viser, at doser på op til 700 mg/kg af ceftriaxon var uden nævneværdig virkning på fertilitet eller embryoføtal udvikling.
English: The CHMP was of the opinion that overall, there is sufficient data from randomised controlled trials to support an indication in UTI (including pyelonephritis).
Danish: CHMP fandt, at der overordnet er tilstrækkelige data fra randomiserede kontrollerede undersøgelser til dokumentation af indikationen urinvejsinfektioner (herunder pyelonefritis).
English: Overall, the CHMP considered that ceftriaxone, used as a comparator agent in EU licensing trials, is an appropriate agent for the treatment of CAP in adults and children.
Danish: Overordnet fandt CHMP, at ceftriaxon, på baggrund af anvendelsen som sammenligningsstof i kliniske undersøgelser med henblik på EU-godkendelsen, er velegnet til behandling af samfundserhvervet pneumoni hos voksne og børn.
English: As agreed with the MAH, the CHMP was of the view that there is insufficient data to support the recommendation for subcutaneous administration of ceftriaxone.
Danish: Både indehaveren af markedsføringstilladelsen og CHMP fandt dataene utilstrækkelige til at underbygge anbefalingen om subkutan administration af ceftriaxon.
English: The MAH's proposed text that the symptoms of overdose - nausea, vomiting and diarrhoea cannot be reduced by haemodialysis or peritoneal dialysis and that there is no specific antidote was considered to be acceptable by the CHMP.
Danish: CHMP godkendte den af markedsføringstilladelsesindehaveren foreslåede tekst om, at symptomerne på overdosering - kvalme, opkastning og diarré - ikke kan reduceres ved hæmodialyse eller peritonealdialyse, og at der ikke er nogen specifik antidot.
English: The changes to the SmPC, when relevant for the user, have also been reflected in the PL and agreed by the CHMP.
Danish: Ændringerne i produktresuméet blev afspejlet i indlægssedlen i det omfang, de er relevante for brugeren, hvilket blev godtaget af CHMP.
English: However IAI was accepted as the indication for ceftriaxone as there are increasing discrepancies in the definition of cIAI and a lack of acceptance of the term amongst many clinicians.
Danish: Intraabdominale infektioner blev dog godtaget som indikation for ceftriaxon, da der er voksende uenighed om definitionen af komplicerede intraabdominale infektioner, en betegnelse, som mange klinikere ikke kan acceptere.
English: Intra-abdominal infections (IAI)
Danish: Intraabdominale infektioner
English: Ceftriaxone has utility in cases of AECB, although the supporting study was small.
Danish: Ceftriaxon er nyttigt ved akutte eksacerbationer af kronisk bronkitis, skønt undersøgelsen til støtte herfor var lille.
English: Overall, there is evidence from controlled clinical trials that ceftriaxone is effective in the treatment of AOM.
Danish: Overordnet foreligger der evidens fra kontrollerede kliniske undersøgelser for, at ceftriaxon er effektivt til behandling af akut otitis media.
English: The CHMP noted that most of the clinical data stem from studies labeled complicated IAI (cIAI), although these studies included a wide variety of conditions.
Danish: CHMP bemærkede, at størstedelen af de kliniske data hidrører fra undersøgelser, som havde overskriften komplicerede intraabdominale infektioner, men dækkede et bredt spektrum af lidelser.
English: Limited clinical data are available in support of the efficacy of ceftriaxone in the treatment of syphilis.
Danish: Der foreligger begrænsede data om ceftriaxons virkning til behandling af syfilis.
English: Therefore, the CHMP considered that the wording of the indication IAI acceptable.
Danish: CHMP fandt derfor, at ordlyden af indikationen intraabdominale infektioner kan godtages.
English: Therefore the MAH's proposal to add Stage II and Stage III nomenclature to this indication was considered to be acceptable by the CHMP.
Danish: CHMP kunne derfor godtage markedsføringstilladelsesindehaverens forslag om at tilføje betegnelserne stadium II og stadium III til denne indikation.
English: However, the use of ceftriaxone has been precluded if the patient has a history of a severe immediate hypersensitivity reaction to any other beta-lactam agent or any other cephalasporin.
Danish: Dog udelukkes det at anvende ceftriaxon ved anamnese med tidligere svær hypersensibilitet af straks-typen over for andre betalactamantibiotika eller cefalosporiner.
English: In view of the available data, the antimicrobial activity of ceftriaxone in the indication of uncomplicated SSTI (uSSTI) is not considered to be appropriate for this agent.
Danish: Ud fra de foreliggende data findes den antimikrobielle aktivitet af ceftriaxon ikke velegnet til indikationen ukomplicerede infektioner i hud og underliggende væv.
English: Skin and soft tissue infections (SSTIs)
Danish: Infektioner i hud og underliggende væv
English: Section 4.5- Interaction with other medicinal products and other forms of interaction In order to comply with the Guideline on the Summary of product Characteristics, the statement mentioning incompatibilities with amsacrine, vancomycin, fluconazole & aminoglycosides (which is included in the EU CSP) has been moved to Section 6.2 (Incompatibilities).
Danish: Angivelsen af uforligelighed med amsacrin, vancomycin, fluconazol og aminoglykosider (som indgår i de centrale sikkerhedsoplysninger for EU) er flyttet til punkt 6.2 (Uforligeligheder) i henhold til retningslinjerne for produktresuméer.
English: Taking into account the additional amendments to bring the wording is in line with the recommendations made in the Guideline on the Summary of Product Characteristics (2009), this section was considered to be acceptable by the CHMP.
Danish: Dette blev godtaget af CHMP i betragtning af de yderligere ændringer, der bringer ordlyden i overensstemmelse med anbefalingerne i retningslinjerne for produktresuméer (2009).
English: • Hospital-acquired pneumonia (HAP)
Danish: • Hospitalserhvervet pneumoni
English: It is not expected that a parenteral antibacterial agent would be prescribed or appropriate in truly uncomplicated UTIs (uUTI).
Danish: Et parenteralt antibiotikum vil normalt ikke blive ordineret ved egentlige ukomplicerede urinvejsinfektioner og er ikke hensigtsmæssigt.
English: Gonorrhoea, gonococcal arthritis, gonococcal eye infection
Danish: Gonoré, gonokok-artritis, gonokok-øjeninfektioner Der er påvist god klinisk virkning af ceftriaxon som enkeltdosisbehandling af gonoré.
English: • Community-acquired pneumonia (CAP)
Danish: • Samfundserhvervet pneumoni
English: The MAH's proposal to delete the indication for sinusitis, pharyngitis and prostatitis due to the scarcity of robust clinical trials in these conditions was agreed by the CHMP.
Danish: CHMP tilsluttede sig markedsføringstilladelsesindehaverens forslag om at slette indikationen sinuitis, faryngitis og prostatitis på grund af sparsomme fyldestgørende kliniske undersøgelser.
English: There is sufficient data to harmonise the indication for ceftriaxone in complicated SSTI (cSSTI), since the clinical data presented stem mostly from what was labelled as cSSTI.
Danish: Der er tilstrækkelige data til harmonisering af indikationen komplicerede infektioner i hud og underliggende væv, da denne betegnelse er anvendt i størstedelen af de forelagte kliniske data.
English: Lower Respiratory Tract Infections (LRTI)
Danish: Nedre luftvejsinfektioner
English: Data to determine the frequency of Rocephin adverse drug reactions was derived from clinical trials.
Danish: Af de kliniske undersøgelser blev der udledt data til bestemmelse af hyppigheden af bivirkninger med Rocephin.
English: The medicinal product is available in vials as powder for solution for injection or infusion.
Danish: Rocephin leveres i hætteglas som et pulver til injektionsvæske, opløsning, eller infusionsvæske, opløsning.
English: Very rare: allergic reactions.
Danish: Meget sjælden: allergiske reaktioner.
English: The maximum dose is once daily.
Danish: Den maksimale dosis er én gang dagligt.
English: Regularly check your breasts.
Danish: Kontrollér dine bryster regelmæssigt.
English: There are no data available.
Danish: Der foreligger ingen data.
English: * Taken from baseline incidence rates in developed countries.
Danish: * Baseret på baseline-incidensraterne i udviklede lande.
English: This part of section 3 has not been modified during this procedure]
Danish: Denne del af punkt 3 er ikke blevet ændret under denne procedure]
English: No known effect.
Danish: Ingen kendt virkning.
English: *Study in women with no uterus
Danish: *Undersøgelse hos kvinder uden uterus
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende ajourføres af medlemsstatens relevante myndighed, i givet fald i samarbejde med referencemedlemsstaten, i henhold til procedurerne i afsnit III, kapitel 4, af direktiv 2001/83/EF.
English: Intolerance to contact lenses
Danish: Intolerance over for kontaktlinser
English: Vaginitis, including vaginal candidiasis
Danish: Vaginitis, herunder vaginal candidiasis
English: Your doctor will explain the effects of stopping treatment and when to stop it.
Danish: Lægen vil forklare virkningerne af at holde op med behandlingen, og hvornår du skal holde op.
English: He or she will also discuss other possibilities for treatment with you.
Danish: Lægen vil også drøfte andre behandlingsmuligheder med dig.
English: Continue with your treatment as normal.
Danish: Fortsæt med behandlingen, som du plejer.
English: How long should you go on using [invented name]?
Danish: Hvor længe skal du bruge [særnavn]?
English: Your doctor may decide to perform a physical examination.
Danish: Lægen kan beslutte at undersøge dig fysisk.
English: - Significant increase in blood pressure
Danish: - væsentlig blodtryksstigning
English: The additional risk becomes clear within a few years.
Danish: Den forhøjede risiko viser sig i løbet af få år.
English: System organ class (MedDRA)
Danish: Systemorganklasse (MedDRA)
English: Free T4 and free T3 concentrations are unaltered.
Danish: Koncentrationerne af frit T4 og frit T3 er uændrede.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det muliggør løbende overvågning af lægemidlets benefit/risk-forhold.
English: Age range (years)
Danish: Alder (år)
English: The applicator should be cleaned with warm water each time after use.
Danish: Applikatoren rengøres med varmt vand efter hver anvendelse.
English: Treatment may be started on any convenient day.
Danish: Behandlingen kan påbegyndes på en vilkårlig dag.
English: - Systemic lupus erythematosus
Danish: - systemisk lupus erythematosus
English: The relative risk does not change with age or time since menopause.
Danish: Den relative risiko ændres ikke med alderen eller med tiden efter menopausen.
English: In most cases, [invented name] is used for 2-3 weeks.
Danish: I de fleste tilfælde anvendes [særnavn] i 2-3 uger.
English: See your doctor if you notice any changes such as:
Danish: Gå til lægen, hvis du bemærker forandringer såsom:
English: However, it returns to normal within a few years (at most 5) after stopping treatment.
Danish: Den vender dog tilbage til det normale i løbet af få år (højst 5), efter at man er holdt op med behandlingen.
English: 17β-Estradiol is a well-known substance.
Danish: 17β-estradiol er et velkendt stof.
English: - Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented.
Danish: - Resultaterne af det største randomiserede placebokontrollerede studie (WHI-studiet) og det største epidemiologiske studie (MWS) vises nedenfor.