FrancophonIA/ELRC3.0 huggingface dataset:
English: Reyataz capsules have been assessed in four main studies involving patients aged 16 years and over.
Danish: Reyataz i kapselform har været genstand for fire hovedundersøgelser omfattende patienter på 16 år og derover.
English: In the two studies in children aged from 3 months up to 11 years taking boosted Reyataz oral powder, the viral load was undetectable in about half the children after treatment for 48 weeks.
Danish: I de to undersøgelser hos børn fra 3 måneder til 11 år, som tog forstærket Reyataz i oral pulverform, var der ingen »påviselig« virusbelastning hos halvdelen af børnene efter behandling i 48 uger.
English: The final study compared Reyataz plus either ritonavir or saquinavir with ritonavir-boosted lopinavir in 358 patients.
Danish: I den sidste undersøgelse blev Reyataz i kombination med enten ritonavir eller saquinavir sammenlignet med ritonavir-forstærket lopinavir hos 358 patienter.
English: One study compared ritonavir-boosted Reyataz with ritonavir-boosted lopinavir (another antiviral medicine) in 883 patients who had not taken treatment for HIV infection before.
Danish: I en undersøgelse blev ritonavir-forstærket Reyataz sammenlignet med ritonavir-forstærket lopinavir (et andet antiviralt lægemiddel) hos 883 patienter, som ikke tidligere var blevet behandlet for hiv-infektion.
English: In the third study, patients taking ritonavir-boosted Reyataz capsules had similar falls in viral load after 24 and 48 weeks as those taking ritonavir-boosted lopinavir: they had fallen by around 99% after 48 weeks.
Danish: I den tredje undersøgelse oplevede de patienter, der fik ritonavir-forstærket Reyataz i kapselform, efter 24 og 48 uger det samme fald i den virale belastning som dem, der fik ritonavir-forstærket lopinavir, idet den var faldet med omkring 99 % efter 48 uger.
English: What is Reyataz?
Danish: Hvad er Reyataz?
English: In the second study, ritonavir-boosted lopinavir caused a greater reduction in viral load than Reyataz capsules taken without ritonavir after 24 weeks.
Danish: I den anden undersøgelse bevirkede ritonavir-forstærket lopinavir i højere grad end Reyataz i kapselform uden ritonavir en nedsættelse af den virale belastning efter 24 uger.
English: For the full list of restrictions with Reyataz see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Reyataz fremgår af indlægssedlen.
English: For the full list of all side effects reported with Reyataz, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Reyataz fremgår af indlægssedlen.
English: How has Reyataz been studied?
Danish: Hvordan blev Reyataz undersøgt?
English: What is Reyataz used for?
Danish: Hvad anvendes Reyataz til?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Reyataz have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Reyataz.
English: In the patients aged between 6 and 18 years, 81% of those who had not taken HIV treatment in the past (13 out of 16) and 24% of those who had taken it in the past (6 out of 25) had viral loads below 50 copies/ml after 48 weeks.
Danish: Hos patienterne i alderen 6-18 år kunne man efter 48 uger konstatere en viral belastning på under 50 kopier/ml hos 81 % af dem, som ikke tidligere havde fået hiv-behandling (13 ud af 16), og hos 24 % af dem, som tidligere var blevet behandlet (6 ud af 25).
English: How is Reyataz used?
Danish: Hvordan anvendes Reyataz?
English: The Committee decided that Reyataz's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP bemærkede, at Reyataz' virkning var påvist hos patienter på mindst 3 måneder, og som vejede mindst 5 kg. Udvalget fandt, at fordelene ved Reyataz er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Reyataz.
English: What benefit has Reyataz shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Reyataz?
English: At the start of the study, the patients' viral loads were around 88,100 copies/ml, but after 48 weeks, 78% of the patients taking Reyataz (343 out of 440) had viral loads below 50 copies/ml, compared with 76% of those taking lopinavir (338 out of 443).
Danish: der tog Reyataz (343 ud af 440), under 50 kopier/ml, i forhold til 76 % af dem, der tog lopinavir (338 ud af 443).
English: Reyataz must not be used in patients who have severe reductions in their liver function; if given with ritonavir it must not be used in patients with moderate reduction in liver function.
Danish: Lægemidlet givet i kombination med ritonavir må heller ikke anvendes til patienter med moderat nedsat leverfunktion.
English: How does Reyataz work?
Danish: Hvordan virker Reyataz?
English: Neonates and children
Danish: Nyfødte og børn
English: Specific indications are discussed below by site of infection.
Danish: Specifikke indikationer er omtalt nedenfor efter infektionssted.
English: Infections in Neutropenic Patients
Danish: Infektioner hos neutropeniske patienter
English: Septicaemia, bacteraemia
Danish: Septikæmi, bakteriæmi
English: These studies used a number of different regimens of Tazocin and a variety of comparators, each administered with or without an aminoglycoside in different studies.
Danish: I disse undersøgelser blev der anvendt en række forskellige regimer af Tazocin og en række sammenligningslægemidler, som hver især blev administreret med eller uden aminoglycosid i forskellige undersøgelser.
English: “Complicated intra-abdominal infections”
Danish: ”Komplicerede intraabdominale infektioner”.
English: For all indications, differences in clinical practices and national treatment recommendations are addressed by the sentence “Consideration should be given to official guidance on the appropriate use of antibiotics.”
Danish: For alle indikationer er forskelle i klinisk praksis og nationale behandlingsanbefa sætningen "Der skal tages højde for de officielle retningslinjer for korrekt anvendel midler".
English: The CHMP noted the data submitted.
Danish: CHMP noterede sig de fremsendte data.
English: The CHMP therefore deleted the indication.
Danish: CHMP slettede derfor indikationen.
English: The CHMP revised the wording of the indication to reflect the study population in the pivotal study and current practice and brought it in line with the indication in adults.
Danish: CHMP reviderede formuleringen af indikationen, så den afspejler undersøgelsesbefolkningen i den pivotale undersøgelse og den aktuelle praksis, og bragte den i overensstemmelse med indikationen hos voksne.
English: However, the wording proposed by the MAH was not in line with the common European terminology or with the wording used in several recently finalised procedures for generics.
Danish: Den formulering, som indehaveren af markedsføringstilladelsen foreslog, var dog ikke i overensstemmelse med den almindelige europæiske terminologi eller med den formulering, der anvendes i en række vedtagne procedurer for generiske lægemidler.
English: Section 4.4 - Special Warnings and Precaution for Use
Danish: Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Infections caused by bacteria with higher MIC values will require more frequent dosing, while more sensitive bacteria may be adequately treated with less frequent dosing.
Danish: Infekt bakterier med højere MIC-værdier kræver hyppigere dosering, mens mere følso behandles tilstrækkeligt med mindre hyppig dosering.
English: Several member states used outdated wording of the Systemic Organ Classes (SOC) and the ADRs were in some cases listed with different frequencies.
Danish: Flere medlemsstater anvendte en forældet formulering af systemorganklasser, og bivirkningerne var i nogle tilfælde anført med forskellige hyppigheder.
English: With regards to the method of administration, the CHMP recommended intravenous infusion over 30 minutes based on the relationship between efficacy and the time during which the free (unbound) drug concentration in blood exceeds the MIC of the organism (T > MIC).
Danish: Hvad angår indgivelsesmåden, anbefalede CHMP intravenøs infusion i løbet af minutter baseret på forholdet mellem virkning og den tid, hvor den lægemiddelkoncentration i blodet overstiger MIC for organismen (T > MIC).
English: In conclusion, the CHMP adopted the following harmonised indications:
Danish: CHMP vedtog således følgende harmoniserede indikationer:
English: Where an agent may be used in certain patient subpopulations (e.g. immunocompromised patients), it is still required that indications should be as specific as possible based on the available data.
Danish: Et stof kan bruges til visse pa immunkompromitterede patienter), men det kræves stadig, at indikationerne er muligt baseret på de tilg
English: Similarly, the clinical and pharmacokinetic data from comparative studies in adults and children, as well as wide clinical experience in children aged > 2 years, support the safety and efficacy in the treatment of intra-abdominal infections in paediatric patients.
Danish: På samme måde understøtter de kliniske og farmakokinetiske data fra sammenlignende undersøgelser hos voksne og børn samt omfattende klinisk erfaring med børn i alderen > 2 år sikkerheden og virkningen ved behandling af intraabdominale infektioner hos pædiatriske patienter.
English: This is why the drug should not be used in less severe infections, where more appropriate alternatives are available and instead be used in severely ill patients for cases of CAP that require hospitalisation.
Danish: Derfor må lægemidlet ikke anvendes ved mindre svær findes mere passende alternativer, og skal i stedet anvendes til alvorligt syge p samfundserhvervet pneumoni, som kræver hospitalsindlæggelse.
English: Section 6 - PHARMACEUTICAL PARTICULARS
Danish: Punkt 6 - Farmaceutiske oplysninger
English: Tazocin was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, due to the divergent national decisions taken by Member States concerning the authorisation of the product.
Danish: Tazocin blev medtaget på den liste over lægemidler, for hvilke produktresuméerne s fordi medlemsstaterne havde truffet forskellige nationale beslutninger med hensyn lægemidlet.
English: For each of the three drug substance manufacturers (the two separate manufacturer for piperacillin and the tazobactam manufacturer), the MAH presented and discussed general information, the manufacture, the control of drug substance, the reference standard or materials, the container closure system and the stability.
Danish: For hver af de tre producenter af lægemiddelstoffer (de to separate producenter for piperacillin og producenten af tazobactam) fremlagde og drøftede indehaveren af markedsføringstilladelsen de generelle oplysninger, fremstillingen, kontrollen med lægemiddelstofferne, referencestandarden eller materialerne, beholderens lukkesystem og stabiliteten.
English: “Complicated urinary tract infections (including pyelonephritis)”
Danish: "Komplicerede urinvejsinfektioner, herunder pyelonefritis".
English: After the initial assessment, a number of lists of outstanding issues were discussed.
Danish: Efter den indledende vurdering blev en række uafklarede spørgsm udarbejdelsesgruppe mødtes to gange.
English: The CHMP agreed on a dosage of 4 g piperacillin/0.5 g tazobactam given every 6 to 8 hours.
Danish: CHMP godkendte piperacillin/0,5 g tazobactam indgivet hver sjette til ottende time.
English: Following a number of clarifications, the MAH proposal was accepted and the CHMP adopted a harmonised Module 3.
Danish: Efter en række afklaringer blev forslaget fr a indehaveren af markedsføringstilladelsen godkendt, og CHMP vedtog et harmoniseret afsnit 3.
English: The MAH provided an overview of the divergences in the nationally approved wordings and proposed a harmonised wording for this section, updated in accordance with the current MedDRA terminology.
Danish: Indehaveren af markedsføringstilladelsen gav en oversigt over forskellene mellem de nationalt godkendte tekster og forslog en harmoniseret tekst til dette punkt, som var opdateret i overensstemmelse med den aktuelle MedDRA-terminologi.
English: The MAH provided a ‘CMC-Divergence Overview' document describing the changes performed to all the existing national dossiers.
Danish: Indehaveren af markedsføringstilladelsen fremsendte et CMC-dokument med en oversigt over forskellene, som beskrev ændringerne i alle de eksisterende nationale dossierer.
English: Section 4.6 - Fertility, pregnancy and lactation
Danish: Punkt 4.6 - Fertilitet, graviditet og amning amning var det samme
English: Its clinical role has been strengthened by the addition of an irreversible β-lactamase-inhibitor (tazobactam), which protects piperacillin against enzymatic degradation from β-lactamase-producing bacteria and therefore expanding the antimicrobial spectrum.
Danish: Den kliniske betydning er blevet styrket med irreversibel β-lactamase-hæmmer (tazobactam), som beskytter piperacillin mod nedbrydning som følge af β-lactamase-producerende bakterier, hvorved det antimik er blevet udvidet.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Tazocin and associated names (see Annex I).
Danish: • produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen n og udvalgets videnskabelige drøftelse, anbefalede CHMP ændringen af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Tazocin og relaterede navne (se bilag I).
English: It was noted that piperacillin-tazobactam had similar efficacy as the comparator used in the studies and that all cases of “bacteraemia” were in patients with one or more of the other indications.
Danish: D at piperacillin-tazobactam havde samme effekt som det sammenligningsstof, der bl undersøgelserne, og at alle tilfælde af "bakteriæmi" forekom hos patienter med en el øvrige indikationer.
English: “Complicated skin and soft tissue infections (including diabetic foot infections)”
Danish: "Komplicerede hud- og bløddelsinfektioner, herunder diabetiske fodinfektioner".
English: Tazocin may be used in the management of neutropenic children with fever suspected to be due to a bacterial infection”
Danish: Tazocin må anvendes til behandling af neutropeniske børn med feber, der formodes at skyldes en bakterieinfektion".
English: Regarding adult and adolescent patients (> 12 years of age), the dosage depends on the severity, location of the infection and the indication.
Danish: For voksne og unge pa afhænger dosen af sværhedsgrad, infektionssted og indikation.
English: The CHMP agreed with the available information on the interaction studies and adopted a harmonised wording for Section 4.5.
Danish: CHMP godkendte de tilgængelige oplysninger om interaktionsundersøgelserne og vedtog en harmoniseret tekst til punkt 4.5.
English: “Tazocin may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection”
Danish: ”Tazocin må anvendes til behandling af neutropeniske patienter med feber, der formodes at skyldes en bakterieinfektion".
English: The total evidence suggests that 4.5 g administered either 8 hourly, or preferably 6 hourly, provides satisfactory efficacy in the treatment of patients with HAP and VAP.
Danish: Den samlede evidens viser, at 4,5 g administreret hver ottende time eller helst hver sjette time sikrer tilfredsstillende virkning ved behandling af patienter med hospitalserhvervet pneumoni og respiratorerhvervet pneumoni.
English: Gastrointestinal, Biliary and Abdominal Infections The CHMP assessed the submitted data and noted that all involved member states included the indication intra-abdominal infections, although the exact wording differed.
Danish: Gastrointestinale infektioner, ga CHMP vurderede de fremsendte data og bemærkede, at alle de involverede medlemsstater anfører ktioner, selv om den præcise formulering varierer.
English: Information on hypersensitivity to the active substances or any of the other ingredients and class specific hypersensitivity to β-lactams and β-lactamase inhibitors was included and the MAH proposed a harmonised wording in line with its current Core Data Sheet.
Danish: Information om overfølsomhed over for de aktive stoffer eller klassespecifik overfølsomhed over for β-lactamer og β-lactamase-hæmmere indehaveren af markedsføringstilladelsen foreslog en harmoniseret formulering i med indehaverens aktuelle Core Data Sheet.
English: Based on the numerous clinical studies, the pharmacokinetic properties of Tazocin and its antibacterial spectrum, the efficacy of the drug is established in this indication, but the CHMP also noted that uncomplicated UTI is a very common infection and according to international guidance documents, there are several recommended treatment options, generally not including Tazocin.
Danish: Baseret på de mange kliniske undersøgelser, de fa egenskaber for Tazocin og lægemidlets antibakterielle spektrum er lægemidlets vi denne indikation, men CHMP bemærkede også, at ukompliceret urinvejsinfekt almindelig infektion, og at der i henhold til internationale vejledning behandlingsmuligheder, som generelt ikke omfatter Tazocin.
English: Although pharmacokinetic data suggest that piperacillin and tazobactam concentrations in both bone and synovial tissue are sufficient to treat the majority of infections caused by susceptible organisms, the available clinical documentation is considered too limited and insufficient to justify an indication in treatment of bone and joint infections.
Danish: Selv om farmakokinetiske data viser, tazobactamkoncentrationer i både knogle- og synovialvæv er tilstrækkelige til at infektioner forårsaget af modtagelige organismer, vurderes det, at den til dokumentation er for begrænset og utilstrækkelig til at begrunde en indikation knogle- og ledinfektioner.
English: “Severe pneumonia including hospital-acquired and ventilator-associated pneumonia”
Danish: "Svær pneumoni, herunder hospitalserhvervet og respiratorerhvervet pneumoni"
English: The MAH noted no major differences in the nationally approved SPCs for Section 4.8.
Danish: Indehaveren af markedsføringstilladelsen anførte ingen væsentlige forskelle i de nationalt godkendte produktresuméer for punkt 4.8.
English: The CHMP assessed the submitted data but considered that the terms “respiratory tract infection” (RTI) and “lower respiratory tract infections” (LRTI) are non-specific and that their precise meaning is open to interpretation and therefore separated the discussion into community acquired pneumonia (CAP) and hospital acquired pneumonia (HAP), including ventilator acquired pneumonia (VAP).
Danish: CHMP vurderede de fremsendte data, men fandt, at betegnelserne "luftvejsinfektion" (RTI luftvejsinfektioner" (LRTI) er uspecifikke, og at deres præcise betydning er åben fo opdelte derfor drøftelsen i samfundserhvervet pneumoni og hospitalserhvervet p respiratorerhvervet pneumoni.
English: Regarding children aged 2-12 years with normal renal function, the CHMP agreed to a dosage of 80/10 mg/kg every 6 hours for neutropenic children and 100/12.5 mg/kg every 8 hours for complicated intra-abdominal infections.
Danish: Med hensyn til børn i alderen 2-12 år med normal nyrefunktion vedt dosis på 80/10 mg/kg hver sjette time for neutropeniske børn og 1
English: Results from three single-dose, open label studies to characterize the tissue penetration of piperacillin-tazobactam were provided but these data alone could not justify the indication claimed.
Danish: Resultater fra tre åbne undersøgelser med enkelt dosis med henblik vævspenetrationen af piperacillin-tazobactam blev fremlagt, men disse data kan ikke al den indikation, der ansøges om.
English: The MAH stated that the contents of the section ‘4.6 Pregnancy and lactation' were the same in all countries although the wording used was slightly different.
Danish: Indehaveren af markedsføringstilladelsen anførte, at indholdet af punkt 4.6 om fertilitet, graviditet og i alle medlemsstater, selv om den anvendte formulering varierede let.
English: • the scope of the referral was the harmonisation of the summary of products characteristics,
Danish: • formålet med indbringelsen af sagen var at harmonisere produktresuméet, etik indlægssedlen,
English: The CHMP considered that AECB could not be accepted due to the lack of a superiority study.
Danish: CHMP fandt, at akut forværring af kronisk bronkitis ikke kunne accepteres på grund af manglen på en overlegenhedsundersøgelse.
English: The CHMP decided to remove the triple combination (intramuscular administration with lidocaine) from the scope of the procedure, in line with the notification.
Danish: (intramuskulær administration med lidocain) fra procedurens omfang i overe anmeldelsen.
English: In view of the submitted data and the clinical experience of the safety and efficacy of piperacillin-tazobactam in neutropenic and nonneutropenic children, the CHMP considered the inclusion of the paediatric indications in neutropenic children to be justified.
Danish: På grundlag af de fremsendte data og den kliniske erfaring g virkningen af piperacillin-tazobactam hos neutropeniske og ikke-neutropeniske f de pædiatriske indikationer hos neutropeniske børn var begrundet.
English: The CHMP noted the submitted data and that the indication bone and joint infections were approved in about half the EU member states.
Danish: CHMP noterede sig de fremsendte data og bemærkede, at indikationen knogle- og godkendt i halvdelen af EU's medlemsstater.
English: The CHMP agreed with the MAH proposal but enforced some additions, in particular by inserting a caution regarding use in patients without severe hypersensitivity reaction to non-penicillin β-lactams but who may have had non-severe reactions and by supplementing the warning on pseudomembranous colitis.
Danish: CHMP godkendte forslaget fra indehaveren af markedsførin nogle tilføjelser, herunder indsættelse af en forsigtighedsregel vedrørende brug svær overfølsomhedsreaktion over for β-lactamer, der ikke er af penicillintypen haft ikke-alvorlige reaktioner, og uddybning af advarslen om pseudomembra om udviklingen af resistente organismer blev indsat.
English: The CHMP considered Tazocin to be a very valuable agent due to its broad antibacterial activity including many Gram-positive and Gram-negative pathogens, anaerobes as well as several multi-drug resistant organisms common in nosocomial infections.
Danish: CHMP fandt, meget værdifuldt stof som følge af dets brede antibakterielle aktivitet, herunder m og gramnegative patogener, anaerobe bakterier og flere multiresistente organis nosokomielle infektioner.
English: The CHMP considered the justification provided by the MAH to be acceptable but included a mention of studies showing developmental toxicity in animals.
Danish: CHMP fandt begrundelsen fra indehaveren af markedsføringstilladelsen medtog en bemærkning om, at undersøgelser viste udviklingstoksicitet hos dyr.
English: Piperacillin sodium is a semi-synthetic ureidopenicillin with broad spectrum anti-bacterial activity, used for the treatment of infections caused by Pseudomonas aeruginosa, and other susceptible bacteria.
Danish: Piperacillinnatrium er en semisyntetisk ureido-penicillin med et b antibakteriel aktivitet, der bruges til behandling af infektioner forårsaget af Pseud og andre modtagelige bakterier.
English: Module 2 (QOS) was also updated in line with Module 3.
Danish: Afsnit 2 (Kvalitetsrelateret generelt resumé) blev også opdateret i overensstemmelse med afsnit 3.