natgillin/translations-raw huggingface dataset:
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
I overensstemmelse med dikation og i d gennemførelse af en retrospektiv analyse fandt CHMP dog, at piperacillin-tazobactam har en bredspektret antibakteriel aktivitet og derfor er velegnet tion:
However, taking into account the view of the CHMP drafting group and despite the very limited data for this indication and acknowledging the difficulties of conducting retrospective analysis, the CHMP was of the opinion that piperacillin-tazobactam has broad-spectrum antibacterial activity and is therefore a suitable option for the treatment of bacteraemia.
CHMP vurderede derfor, at der blev givet tilstrækkelig evidens som dokumentation for brugen af Tazocin til behandling af hospitalserhvervet pneumoni og respiratorerhvervet pneumoni.
Therefore, the CHMP considered the evidence sufficient to support the use of Tazocin in the treatment of HAP and VAP.
lle de komparative undersøgelser var g hver sjette time, som oprindeligt blev godkendt i USA.
The CHMP assessed the data submitted but noted that the comparative studies were all performed at the initial US-approved regimen of 3.375 g every 6 hours.
CHMP indførte og over doserne.
The CHMP also implemented a tabular presentation of the doses.
ling af moderate til samt hud- og række infektioner ladelsen benyttede lejligheden til at harmonisere punkt 3 og indgav et opdateret kvalitetsrelateret generelt resumé.
The Marketing Authorisation Holder (MAH) took the opportunity to harmonise Module 3 and submitted an updated Quality Overall Summary (QOS).
CHMP noterede sig de fremsendte data og anerkendte, at flere undersøgelser har på sikkerhed og virkning til behandling af patienter med septikæmi, og at bredspektred f.eks. piperacillin-tazobactam, bredt anvendes i klinisk praksis i sådanne situatione at den underbyggende dokumentation generelt er hentet fra undersøgelser af fe kun ca. en fjerdedel af patienterne i forskellige undersøgelser havde "bakteriæmi".
The CHMP noted the data submitted and acknowledged that several studies have demonstrated the safety and efficacy of Tazocin in the management of patients with septicaemia and that broadspectrum agents such as piperacillin-tazobactam are widely used in clinical practice in these situations.
CHMP krævede ev formuleret i streng overensstemmelse med de /558/95 rev. 1 - Note for Guidance on Evaluation of Medicinal velse af arter.
The CHMP required a complete re-write of the section, written strictly in accordance with current guideline (NfG on evaluation of medicinal products indicated for treatment of bacterial infections CPMP/EWP/558/95 rev 1) and without excessive listings of species.
Punkt 4.2 - Dosering og indgivelsesmåde
Section 4.2 Posology and method of administration
CHMP vedtog en udtalelse om, at den sædvanlige leste indikationer er på 5-14 dage, men at varigheden af ientens kliniske og nogen af de øvrige indholdsstoffer og var inkluderet, og overensstemmelse tekst til punkt 4.3.
The CHMP agreed on a statement that the usual duration of treatment for most indications is in the range of 5-14 days but that the duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress.
Nedre luftvejsinfektioner navne (se bilag I)
Overall summary of the scientific evaluation of Tazocin and associated names (see Annex I)
Afsnit 3
Module 3
Indehaveren af markedsføringstilladelsen anførte, at alle nødvendige oplysninger va medlemsstater, men erklæringerne varierede med hensyn til detaljeringsgrad.
The MAH stated that all required information is present in all countries, but the statements differ in the depth of elaborations.
CHMP fandt, ktioner i hud og ktioner i hud og æv er velunderbygget af en række kliniske undersøgelser, behandlingsretningslinjer fra videnskabelige sammenslutninger og erfaring fra kliniske praksis.
The CHMP considered that the studies suggests that Tazocin is efficacious in the treatment of cSSTI and was of the opinion that the safety and efficacy of Tazocin in the treatment of skin and soft tissue infections is well justified by numerous clinical studies, treatment guidelines from scientific societies and experience from clinical practice.
bruger den samme MIC (mindste hæmmende koncentration) baseret på UK-brea følge af nationale godkendelser og forskellige godkendelsestidspunkter var der fremlæggelsen af oplysningerne, og resuméet/listen over modtagelige organism Indehaveren af markedsføringstilladelsen fremsendte kun in vitro-data til støtte udpegede de patogener, hvor der var påvist en klinisk virkning i en komplet omformulering af punktet, så det bl gældende retningslinjer (CPMP/EWP
All member states use the same minimum inhibitory concentration (MIC) based on UK-breakpoints but due to national approvals and different approval times there were minor divergences in the presentation of the data and also the summary/listing of susceptible organism differed slightly.
CHMP medtog kun de prækliniske oplysninger, som er relevante for de og den nuværende viden om lægemidlets reproduktionstoksicitet, jf. den tekst, der er godkendt for af off Indehaveren af markedsføringstilladelsen accepterede, og CHMP vedtog en harmonis
The CHMP included only the preclinical information relevant to prescribers and also the current state of knowledge about the reproductive toxicity of the product, in line with the text approved for recent EU procedures for generics of piperacillin-tazobactam and including a summary of published data about the reproductive toxicity testing of piperacillin and tazobactam.
Knogle- og ledinfektioner
Bone and Joint Infections
Som allerede anført tazobactam forbeholdes situationer, h sstater anfører éer er begrænset til rmakokinetiske rkning fastlagt for ion er en meget er er flere anbefalede bør piperacillinvor der kræves et bredspektret stof, dvs. det bør ikke anvendes P vurderede derfor, at Tazocin ikke er velegnet til rutinebehandling af ukomplicerede urinvejsinfektioner.
As already stated, piperacillintazobactam should be preserved for situations where a broad-spectrum agent really is required, i.e. not for the treatment of non-severe infections.
Indehaveren af markedsføringstilladelsen foreslog en tekst i overensstemmelse med indehaverens Core Data Sheet.
The MAH proposed a wording in line with its Core Data Sheet.
CHMP noterede sig de fremsendte data og bemærkede, at data for voksne blev betr og at de farmakokinetiske data kan bruges til at ekstrapolere virkningen til pædia kliniske data for børn er meget begrænsede og primært skal udledes ved ekstrapola population, vil godkendelsen af indikationer hos denne population være påvirket af d er godkendt for den voksne agtet som relevant, triske patienter.
The CHMP noted the submitted data and considered that the data from adults was considered relevant and that the pharmacokinetic information can be used to extrapolate efficacy to the paediatric population.
Indehaveren af markedsføringstilladelsen bemærkede og gav en oversigt over forske aktuelt godkendte tekst til punkt 4.9 og forslog en harmoniseret tekst i overe indehav markedsføringstilladelsen var acceptabel tilfælde af overdosering og manglen p punkt 4.9.
The MAH noted and provided an overview of the differences between the currently approved wording of Section 4.9 and proposed a harmonised wording in line with its Core Data Sheet.
Vedrørende hospitalserhvervet pneumoni noterede CHMP sig de fremlagte komparative undersøgelser, der involverede patienter med hospitalserhvervet pneumoni alene, hospitalserhvervet pneumoni og respiratorerhvervet pneumoni eller respiratorerhvervet pneumoni alene.
Regarding HAP, the CHMP noted the presented comparative studies which included patients with HAP only, HAP including VAP or VAP only.
For lægemidlet fremlagde og drøftede indehaveren af markedsføringstilladelsen beskrivelsen og sammensætningen af lægemidlet, lægemiddeludviklingen,
For the drug product, the MAH presented and discussed the description and composition of the drug product, the pharmaceutical development, the manufacture, control of excipients, the control of drug products, the reference standard, the container closure system and the stability.
Products Indicated for Treatment of Bacterial Infections) og uden unødvendig angi EUCAST MIC-breakpoints og kun arter, der er relevante for den godkendte indik Indehaveren af markedsføringstilladelsen reviderede tabellen over almindeligt føls godkendte det reviderede forslag og vedtog en harmoniseret te
Only EUCAST MIC breakpoints and only species relevant for the approved indication were listed.
CHMP vedtog således en harmoniseret tekst til punkt 4.2.
In conclusion, the CHMP adopted a harmonised wording for Section 4.2.
Forslaget fra indehaveren af markedsføringstilladelsen var i overensst Data Sheet.
The MAH proposal was in line with its Core Data Sheet.
des at være forbundet med en af de infektioner, som er anført ovenfor".
"Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above".
CHMP vedtog en harmoniseret tekst til punkt 5.2.
A harmonised wording was adopted for Section 5.2.
kliniske erfaringer og trods de begrænsede data, at Tazocin dækker de fl forårsager svær samfundserhvervet pneumoni, hospitalserhverve pneumoni.
In conclusion, in line with the position of the CHMP drafting group, taking into account the extensive clinical experience and despite the limited data, The CHMP considered that Tazocin covers most organisms responsible for causing severe CAP, HAP and VAP.
CHMP noterede sig de fremsendte data, men fandt dem utilstrækkelige til at und indikation, der blev ansøgt om, eller en uddybet version af denne indikation.
Gynaecological Infections including postpartum endometritis and pelvic inflammatory disease The CHMP noted the submitted data but considered inadequate to support the broad indication claimed or any qualified version of this indication.
Indikationer skal tientgrupper (f.eks. så specifikke som ængelige data.
Indications have to be infection (site) specific.
Indehaveren af markedsføringstilladelsen forslog en tekst i overensstemmelse med Data Sheet.
The MAH presented a proposed wording in line with its Core Data Sheet.
CHMP vedtog således en harmoniseret
The CHMP adopted the following harmonised indication:
Indehaveren af markedsføringstil
labelling and package leaflet
Punkt 4.7 - Virkning på evnen til at føre motorkøretøj eller betjene maskiner overensstemmelse med indehaveren af markedsføringstilladelsens Core Data Sheet.
The section 4.8 is in all countries consistent with the MAH Core Data Sheet.
Samlet resumé af den videnskabelige vurdering af Tazocin og relaterede kulle harmoniseres, til godkendelse af redt spektrum af omonas aeruginosa tilsætningen af en enzymatisk robielle spektrum amase-hæmmende v om det betragtes som stærkere.
Tazobactam is a penicillanic acid sulfone derivative with β-lactamase inhibitory properties similar to those of sulbactam although it is regarded as more potent.
Følgende konvention er brugt til klassificering af hyppigheden:
The following convention has been used for classification of frequency:
a Foretrukken term i MedDRA (version 16).
a MedDRA preferred term (Version 16).
Elleve af de tolv patienter døde ikke-bevidnet.
Eleven of the 12 patients had an unwitnessed death.
Se også afsnit 2 under 'Advarsler og forsigtighedsregler'.
See also section 2 under “Warnings and precautions”.
c Baseret på laboratoriemålinger.
c Based on laboratory assessments.
Dosisjusteringer er ikke nødvendige for disse subpopulationer.
No dose adjustment is necessary for these subpopulations.
Demografi og baseline-karakteristika var balanceret mellem armene.
Demographics and baseline characteristics were balanced between arms.
Det skal sikres, at der forefindes genoplivningsudstyr.
Availability of resuscitation equipment must be ensured.
Den estimerede tid til at nå steady state var ca. 70 dage.
The predicted time to reach steady state was approximately 70 days.
Dette svarer til en halveringstid på ca. 14 dage.
This corresponds to a half-life of approximately 14 days.
Behandling af enhver infektion skal påbegyndes i henhold til lokale standarder.
Treatment of any infection should be initiated according to local standards.
Kortvarig eksponering for omgivende lys er acceptabelt, mens klargøring og administration finder sted.
Brief exposure to ambient light is acceptable while preparation and administration is taking place.
Portrazza må ikke gives til patienter under 18 år, da der ikke findes information om, hvordan lægemidlet virker hos denne aldersgruppe.
Portrazza should not be given to patients under the age of 18 years because there is no information about how it works in this age group.
Infusionens varighed bør ikke overstige 2 timer.
The infusion duration should not exceed 2 hours.
Dette protein kaldes epidermal vækstfaktorreceptor (EGFR).
The protein is known as epidermal growth factor receptor (EGFR).
[Nordamerika, Europa og Australien vs. Sydamerika, Sydafrika og Indien vs. Østasien])
America, Europe, and Australia vs. South America, South Africa, and India vs. Eastern Asia])
Det kan ikke udelukkes, at nyfødte/spædbørn udsættes for en risiko.
A risk to newborns/infants cannot be excluded.
Patienterne gennemgik radiologisk vurdering af sygdomsstatus hver 6. uge, indtil der var radiologisk dokumentation for progressiv sygdom (PD).
Patients underwent radiographic assessment of disease status every six weeks, until radiographic documentation of progressive disease (PD).
Fordelingen af Portrazza følger et bifasisk fald.
Distribution of Portrazza follow a biphasic decline.
aGrad i henhold til NCI-CTCAE, version 3.0.
a Grade per NCI-CTCAE, Version 3.0
Opbevares beskyttet mod lys.
Store protected from light.
Omfatter kun patienter med baseline og mindst én efterfølgende måling.
Only patients with baseline and at least one post-baseline result are included.
Toksicitet hos ældre og patienter med ECOG PS2
Toxicity in the elderly or in patients with ECOG PS 2
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1084/001
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1084/001
Det primære endepunkt var samlet overlevelse (OS), og det understøttende endepunkt var progressionsfri overlevelse (PFS).
The major efficacy outcome measure was overall survival (OS) and the supportive efficacy outcome measure was progression-free survival (PFS).
Hændelserne debuterede primært under den første behandlingsserie.
The onset of events occurred mainly during the first cycle of treatment.
Det anbefales, at den klargjorte opløsning til dosering anvendes med det samme for at minimere risikoen for mikrobiel kontaminering.
It is recommended that the prepared dosing solution be used immediately in order to minimize the risk of microbial contamination.
ECOG PS var 0 for 31,5 % af patienterne, 1 for 59,7 % af patienterne og 2 for 9 % af patienterne, og over 50 % havde metastatisk sygdom mere end 2 steder.
The ECOG PS was 0 for 31.5 %, 1 for 59.7 %, and 2 for 9 % of patients; over 50 % had metastatic disease at more than 2 sites.
- Infektioner Hvis du har tegn på infektion, før du starter behandlingen, skal du fortælle din læge det.
- Infections If you have signs of infection before start of treatment please tell your doctor.
Medianalderen var 62 år (32-86), 83 % af patienterne var mænd, 83,5 % var kaukasiere, og 91 % var rygere.
Median age was 62 (32-86), 83 % of patients were men; 83.5 % were Caucasian; and 91 % were smokers.
Kaplan Meier kurve for samlet overlevelse (ITT population)
Kaplan Meier plot of overall survival (ITT population)
Risikoen for nedsat fertilitet kendes ikke.
The risk of fertility impairment is unknown.
En tumor blev betragtet som EGFR-udtrykkende, hvis mindst én farvet celle kunne identificeres.
A tumour was considered to be EGFRexpressing if at least one stained cell could be identified.
Kontakt omgående lægen eller sundhedspersonalet, hvis noget af følgende gælder for dig (eller hvis du er i tvivl) under eller efter behandlingen med Portrazza:
Talk to your doctor or nurse immediately if any of the following applies to you (or you are not sure) during or after treatment with Portrazza: