natgillin/translations-raw huggingface dataset:
Flere medlemsstater anvendte en forældet formulering af systemorganklasser, og bivirkningerne var i nogle tilfælde anført med forskellige hyppigheder. 
Several member states used outdated wording of the Systemic Organ Classes (SOC) and the ADRs were in some cases listed with different frequencies.
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). 
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).
CHMP vedtog således følgende harmoniserede indikationer: 
In conclusion, the CHMP adopted the following harmonised indications:
Et stof kan bruges til visse pa immunkompromitterede patienter), men det kræves stadig, at indikationerne er muligt baseret på de tilg 
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.
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. 
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.
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. 
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.
Punkt 6 - Farmaceutiske oplysninger 
Section 6 - PHARMACEUTICAL PARTICULARS
Tazocin blev medtaget på den liste over lægemidler, for hvilke produktresuméerne s fordi medlemsstaterne havde truffet forskellige nationale beslutninger med hensyn lægemidlet. 
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.
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. 
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.
"Komplicerede urinvejsinfektioner, herunder pyelonefritis". 
“Complicated urinary tract infections (including pyelonephritis)”
Efter den indledende vurdering blev en række uafklarede spørgsm udarbejdelsesgruppe mødtes to gange. 
After the initial assessment, a number of lists of outstanding issues were discussed.
CHMP godkendte piperacillin/0,5 g tazobactam indgivet hver sjette til ottende time. 
The CHMP agreed on a dosage of 4 g piperacillin/0.5 g tazobactam given every 6 to 8 hours.
Efter en række afklaringer blev forslaget fr a indehaveren af markedsføringstilladelsen godkendt, og CHMP vedtog et harmoniseret afsnit 3. 
Following a number of clarifications, the MAH proposal was accepted and the CHMP adopted a harmonised Module 3.
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. 
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.
Indehaveren af markedsføringstilladelsen fremsendte et CMC-dokument med en oversigt over forskellene, som beskrev ændringerne i alle de eksisterende nationale dossierer. 
The MAH provided a ‘CMC-Divergence Overview' document describing the changes performed to all the existing national dossiers.
Punkt 4.6 - Fertilitet, graviditet og amning amning var det samme 
Section 4.6 - Fertility, pregnancy and lactation
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. 
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.
• 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). 
• 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).
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. 
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.
"Komplicerede hud- og bløddelsinfektioner, herunder diabetiske fodinfektioner". 
“Complicated skin and soft tissue infections (including diabetic foot infections)”
Tazocin må anvendes til behandling af neutropeniske børn med feber, der formodes at skyldes en bakterieinfektion". 
Tazocin may be used in the management of neutropenic children with fever suspected to be due to a bacterial infection”
For voksne og unge pa afhænger dosen af sværhedsgrad, infektionssted og indikation. 
Regarding adult and adolescent patients (> 12 years of age), the dosage depends on the severity, location of the infection and the indication.
CHMP godkendte de tilgængelige oplysninger om interaktionsundersøgelserne og vedtog en harmoniseret tekst til punkt 4.5. 
The CHMP agreed with the available information on the interaction studies and adopted a harmonised wording for Section 4.5.
”Tazocin må anvendes til behandling af neutropeniske patienter med feber, der formodes at skyldes en bakterieinfektion". 
“Tazocin may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection”
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. 
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.
Gastrointestinale infektioner, ga CHMP vurderede de fremsendte data og bemærkede, at alle de involverede medlemsstater anfører ktioner, selv om den præcise formulering varierer. 
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.
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. 
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.
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. 
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.
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. 
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.
"Svær pneumoni, herunder hospitalserhvervet og respiratorerhvervet pneumoni" 
“Severe pneumonia including hospital-acquired and ventilator-associated pneumonia”
Indehaveren af markedsføringstilladelsen anførte ingen væsentlige forskelle i de nationalt godkendte produktresuméer for punkt 4.8. 
The MAH noted no major differences in the nationally approved SPCs for Section 4.8.
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. 
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).
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 
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.
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. 
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.
Indehaveren af markedsføringstilladelsen anførte, at indholdet af punkt 4.6 om fertilitet, graviditet og i alle medlemsstater, selv om den anvendte formulering varierede let. 
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.
• formålet med indbringelsen af sagen var at harmonisere produktresuméet, etik indlægssedlen, 
• the scope of the referral was the harmonisation of the summary of products characteristics,
CHMP fandt, at akut forværring af kronisk bronkitis ikke kunne accepteres på grund af manglen på en overlegenhedsundersøgelse. 
The CHMP considered that AECB could not be accepted due to the lack of a superiority study.
(intramuskulær administration med lidocain) fra procedurens omfang i overe anmeldelsen. 
The CHMP decided to remove the triple combination (intramuscular administration with lidocaine) from the scope of the procedure, in line with the notification.
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. 
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.
CHMP noterede sig de fremsendte data og bemærkede, at indikationen knogle- og godkendt i halvdelen af EU's medlemsstater. 
The CHMP noted the submitted data and that the indication bone and joint infections were approved in about half the EU member states.
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. 
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.
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. 
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.
CHMP fandt begrundelsen fra indehaveren af markedsføringstilladelsen medtog en bemærkning om, at undersøgelser viste udviklingstoksicitet hos dyr. 
The CHMP considered the justification provided by the MAH to be acceptable but included a mention of studies showing developmental toxicity in animals.
Piperacillinnatrium er en semisyntetisk ureido-penicillin med et b antibakteriel aktivitet, der bruges til behandling af infektioner forårsaget af Pseud og andre modtagelige bakterier. 
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.
Afsnit 2 (Kvalitetsrelateret generelt resumé) blev også opdateret i overensstemmelse med afsnit 3. 
Module 2 (QOS) was also updated in line with Module 3.
Der er omfattende klinisk erfaring i behandling af neutropeniske voksne og børn > 2 år med feber, glycosid, og sikkerheden -tazobactam er veldokumenteret hos immunkompetente patienter. 
There is vast clinical experience in treating neutropenic adults as well as children > 2 years with fever suspected to be due to bacterial infections, often in combination with an aminoglycoside and the safety of piperacillin-tazobactam is well documented in immunocompetent patients.
CHMP vurderede de fremsendte data og bemærkede, at de fleste medlem urinvejsinfektioner som en indikation, og at indikationen i nogle produktresum komplicerede urinvejsinfektioner. 
The CHMP assessed the submitted data and noted that most member states list urinary tract infections (UTIs) as an indication and that in some SPCs the indication is limited to complicated UTIs.
Begrundelser for ændring af produktresumé, etikettering og indlægsseddel etteringen og 
Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Tazobactam er et sulfonsyrederivat af penicillinsyre med β-lact egenskaber svarende til egenskaberne for sulbactam, sel Kombinationen af piperacillin og tazobactam i forholdet 8:1 er effektiv til behand svære polymikrobiale infektioner, herunder intraabdominale infektioner bløddelsinfektioner, og er godkendt til og markedsføres til behandling af en forårsaget af grampositive og gramnegative aerobe og anaerobe organismer. 
The combination of piperacillin and tazobactam in a ratio of 8:1 is effective in the treatment of moderate to severe polymicrobial infections including intra-abdominal, skin and soft-tissue and is approved and marketed for the treatment of a number of infections caused by gram-positive and gram-negative aerobic and anaerobic organisms.
Vedrørende samfundserhvervet pneumoni noterede CHMP sig, at de ikke-komparat der blev fremlagt i forbindelse med den indledende markedsføringstilladelse, involve luftvejsinfektioner, herunder nedre luftvejsinfektioner og akut forværring af kron 
Regarding CAP, the CHMP noted that the non-comparative studies submitted in the context of the initial MAA were performed involving patients with respiratory tract infections including lower respiratory tract infections and acute exacerbation of chronic bronchitis (AECB).
CHMP udtalte sig generelt om punkt 4.1 og bemærkede, at en indikation hold til disse retningslinjer, hvis de kliniske data støtter et gunstigt benefit-riskr. 
The CHMP provided general comments on Section 4.1, noting that the Note for Guidance states that an indication may be granted if the clinical data support a favourable benefit-risk ratio and reflect the range of type and severity of infections that are commonly encountered.
eret tekst til punkt tog harmoniserede ngstid, punkt 6.4 - Særlige opbevaringsforhold, punkt 6.5 - Emballagetype og pakningsstørrelser og punkt 6.6Regler for destruktion og anden håndtering. 
The CHMP agreed with the MAH proposals and adopted harmonised wordings for Section 6.1 - List of excipients, Section 6.2 Incompatibilities, Section 6.3 Shelf life, Section 6.4 - Special precautions for storage, Section 6.5 - Nature and contents of container and Section 6.6 - Special precautions for disposal and other handling.
Den eneste undersøgelse, der oprindelige europæiske ansøgning for Tazocin t ledinfektioner var underbygger den il indikationen knogle- og ledinfektioner, var dog en v undersøgelse, og der er ikke fremlagt yderligere data fra en komparativ på at karakterisere ene begrunde at piperacillin- og behandle de fleste gængelige kliniske for behandling af åben og ikke-komparati undersøgelse. 
However, the single study supporting the initial European application for Tazocin for the indication bone- and joint infections was an open-labelled non-comparative study and no additional data from any comparative study was provided.
CHM 
Whereas
Infektioner i hud og underliggende væv indikationen intraabdominale infe forslaget fra indehaveren af markedsføringstilladelsen, så det bringes i overensstem aktuelle retningslinjer, og fandt, at den tilgængelige evidens i tilstrækkelig grad støt Tazocin 4,5 g hver ottende time for denne indikation. 
The CHMP revised the MAH proposal to bring it in line with the current guidelines and considered that the available evidence sufficiently supports the use of Tazocin 4.5 g every 8 hours for this indication.
Punkt 4.5 - Interaktion med andre 
Section 4.5 - Interaction with other medicinal products and other forms of interaction
Indehaveren af markedsføringstilladelsen foreslog en liste over harmoniserede henvisning til de aktuelle retningslinjer (EU-retningslinjer for produktresuméer, s CPMP/EWP/558/95 rev. 1 - Note for Guidance on Evaluation of Medicinal Prod Treatment of Bacterial Infections, 2004) og til Core Data Sheet fra markedsføri kan godkendes i hen forhold og afspejler omfanget af type og sværhedsgrad af almindelige infektione være specifikke for infektionen eller infektionsstedet. 
The MAH proposed a list of harmonised indications based upon current guidelines (the EC guideline on SPC, September 2009 and CPMP/EWP/558/95 rev 1 - Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections, 2004) and on the MAH core data sheet (CDS).
Den poolede analyse omfattede patienter med positive blod ingen af undersøgelserne, som prospektivt definerede disse patienter, og derfor er sandsynlighed for, at disse patienter ikke ville opfylde kriteriern vist Tazocins e stoffer, som r. CHMP bemærkede, bril neutropeni, og at et blev bemærket, ev brugt i ler flere af de dyrkninger. 
The pooled analysis included patients with positive blood cultures however none of the studies had prospectively defined these patients and therefore it is very likely that most of these patients would not satisfy the criteria for sepsis.
CHMP fandt, at begrundelsen fra indehaveren af , men tilføjede en sætning om seponering af behandlingen i å en modgift. 
The CHMP considered the MAH justification to be acceptable but added a sentence on discontinuation of treatment in case of overdose and the absence of an antidote.
CHMP fandt, at de ngstilladelsen fremførte for den foreslåede tekst, var en harmoniseret tekst til punkt 4.8. 
The CHMP considered that the justifications provided by the MAH for the proposed wording were acceptable and adopted a harmonised wording for Section 4.8.
kompliceret urinvejsinfektion og pyelonefritis foreslået parall lægemidler og i overensstemmelse med klinisk praksis. 
Instead, the more restricted indication in complicated UTI and pyelonephritis was proposed, in line with other recently harmonised products as well as in compliance with clinical practice.
CHMP vedtog en revideret harmoniseret tekst til punkt 4.7. 
The CHMP adopted a revised harmonised wording for Section 4.7.
Indehaveren af markedsføringstilladelsen anførte følgende indikationer: ikke-depola muskelafslappende lægemidler, perorale antikoagulantia, methotrexat, probenecid, a vancomycin. 
The MAH listed the following interactions: non-depolarizing muscle relaxants, oral anticoagulants, methotrexate, probenecid, aminoglycosides, and vancomycin and provided an overview of the divergences between the nationally approved wordings for Section 4.5.
Efter drøftelser med CHMP's udarbejdelsesgruppe og på grundlag af de samlede tilgængelige data besluttede CHMP at begrænse indikationen og godkendte følgende indikation: 
Following discussions with the CHMP drafting group and based on the total available data, the CHMP decided to restrict the indication and adopted the following indication:
CHMP vedtog endvidere, at det er ikke nødvendigt at tilpasse dosis nedsat leverfunktion. 
The CHMP also agreed that no dose adjustment is necessary in patients with hepatic impairment.
Efter drøftelser med CHMP's udarbejdelsesgruppe og på grundlag af de samlede tilgængelige data besluttede CHMP at omformulere indikationen og godkendte følgende indikation: 
Following discussions with the CHMP drafting group and based on the total available data, the CHMP decided to reword the indication and adopted the following indication:
- Komplicerede hud- og bløddelsinfektioner 
Skin and Soft Tissue Infections