FrancophonIA/ELRC3.0 huggingface dataset:
English: For the 14, 28, 56, 84 and 98 tablets pack sizes, you can check the day on which you last took a tablet of Pioglitazone Actavis by referring to the calendar printed on the blister.
Danish: For tabletterne i 14, 28, 56, 84 og 98-styks pakningerne kan du tjekke på hvilken ugedag, du sidst tog din tablet Pioglitazon Actavis ved at se på kalenderen trykt på blisterpakningen.
English: Talk to your doctor before you start to take this medicine: - if you retain water (fluid retention) or have heart failure problems and in particular if you are over 75 years old.
Danish: Kontakt lægen, før du tager Pioglitazon Actavis: - hvis du har vand i kroppen (ødemer) eller har problemer med hjertesvigt, specielt hvis du er over 75 år.
English: Do not take Pioglitazone Actavis - if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of
Danish: Tag ikke Pioglitazon Actavis - hvis du er allergisk over for pioglitazon, eller et af de øvrige indholdsstoffer i Pioglitazon
English: Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
Danish: Der blev rapporteret ødemer hos 6-9% af patienterne, der blev behandlet i et år med pioglitazon i kontrollerede kliniske studier.
English: Pioglitazone Actavis contains pioglitazone.
Danish: Pioglitazon Actavis indeholder pioglitazon.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon uncommon uncommon uncommon
Danish: God-, ondartede og uspecificerede neoplasmer (inklusiv cyster og polypper) blærekræft ikke almindelig ikke almindelig ikke almindelig ikke almindelig ikke almindelig
English: Pioglitazone Actavis may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Danish: Pioglitazon Actavis kan anvendes alene til patienter, som ikke er i stand til at tage metformin, og hos hvem diæt og motion ikke har været i stand til at kontrollere blodsukkeret, eller det kan anvendes som supplement til andre lægemidler (såsom metformin, sulfonylurinstof eller insulin), hvis dette ikke har været i stand til at kontrollere blodsukkeret tilstrækkeligt.
English: Pioglitazone Actavis with food and drink You may take your tablets with or without food.
Danish: Brug af Pioglitazon Actavis sammen med mad og drikke Du kan tage Pioglitazon Actavis med eller uden et måltid.
English: Pioglitazone Actavis has no or negligible effect on the ability to drive and use machines.
Danish: Pioglitazon Actavis påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Actavis.
Danish: Du kan normalt blive ved med at tage anden medicin, mens du får Pioglitazon Actavis.
English: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
Danish: Som monoterapi hos voksne patienter (specielt overvægtige patienter), der er utilstrækkeligt reguleret via diæt og motion, og for hvem metformin ikke er velegnet på grund af kontraindikationer eller intolerans.
English: Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
Danish: Efter markedsføring er der rapporteret om overfølsomhedsreaktioner hos patienter behandlet med pioglitazon.
English: In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
Danish: I kontrollerede kliniske undersøgelser er hyppigheden af rapporteret hjerteinsufficiens ved pioglitazonbehandling den samme som for placebo-, metformin- og sulfonylurinstof-grupperne, men var forøget ved kombinationsbehandling med insulin.
English: Pioglitazone Actavis tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Danish: Pioglitazon Actavis tabletter indeholder lactosemonohydrat og bør derfor ikke anvendes til patienter med arvelig fructoseintolerans, galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
English: Your blood sugar will be checked, and your dose of Pioglitazone Actavis may need to be changed.
Danish: Du vil få kontrolleret blodsukkeret for at se, om du skal have ændret dosis af Pioglitazon Actavis.
English: Uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness - increased appetite
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) - sukker i urinen, proteiner i urinen - forhøjet enzymtal - svimmelhed, hvor alting drejer rundt (vertigo)
English: A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Danish: Der blev udført en poolet analyse af bivirkninger i form af knoglefrakturer fra randomiserede, komparatorkontrollerede, dobbeltblindede kliniske forsøg med over 8.100 patienter i den pioglitazonbehandlede gruppe og 7.400 patienter i den komparatorbehandlede gruppe, der blev behandlet i op til 3,5 år.
English: Pioglitazone Actavis contains lactose monohydrate If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazone Actavis.
Danish: Pioglitazon Actavis indeholder lactosemonohydrat Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: If you forget to take Pioglitazone Actavis
Danish: Hvis du har glemt at tage Pioglitazon Actavis
English: The usual starting dose is one tablet of 15 mg or of 30 mg of pioglitazone to be taken once daily.
Danish: Den normale start dosis er 1tablet på 15 mg eller 30 mg pioglitazon en gang daglig.
English: If you take more Pioglitazone Actavis than you should If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Danish: Hvis du har taget for mange Pioglitazon Actavis filmovertrukne tabletter Kontakt straks lægen, skadestuen eller apoteket, hvis du ved en fejltagelse har taget for mange tabletter, eller hvis en anden eller et barn tager din medicin.
English: Cardiac disorders heart failure common
Danish: Hjerte hjerteinsufficiens almindelig
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pioglitazone Actavis 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Pioglitazon Actavis 15 mg tabletter Hver tablet indeholder 15 mg pioglitazon (som hydrochlorid).
English: Musculoskeletal and connective tissue disorders fracture bone common common common common common arthralgia common common common back pain common
Danish: Knogler, led, muskler og bindevæv Knoglefraktur almindelig almindelig almindelig almindelig almindelig artralgi almindelig almindelig almindelig rygsmerter almindelig
English: In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
Danish: I kontrollerede kliniske forsøg med aktive stoffer som sammenligning var den gennemsnitlige vægtøgning 2-3 kg i løbet af et år med pioglitazon givet som monoterapi.
English: What you need to know before you take Pioglitazone Actavis
Danish: Det skal du vide, før du begynder at tage Pioglitazon Actavis
English: NAME OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Actavis Group PTC ehf.
English: Pioglitazone Actavis 15 mg, 30 mg and 45 mg tablets Pioglitazone Actavis 15 mg tablets
Danish: Pioglitazon Actavis 15 mg, 30 mg og 45 mg tabletter Pioglitazon Actavis 15 mg tabletter
English: EU/1/12/755/008 EU/1/12/755/009 EU/1/12/755/010 EU/1/12/755/011 EU/1/12/755/012 EU/1/12/755/013 EU/1/12/755/014 EU/1/12/755/015 EU/1/12/755/016 EU/1/12/755/017 EU/1/12/755/018 EU/1/12/755/019 EU/1/12/755/020 EU/1/12/755/021 EU/1/12/755/022 EU/1/12/755/023 EU/1/12/755/024 EU/1/12/755/025 EU/1/12/755/026 EU/1/12/755/027
Danish: EU/1/12/755/001 EU/1/12/755/002 EU/1/12/755/003 EU/1/12/755/004 EU/1/12/755/005 EU/1/12/755/006 EU/1/12/755/007 EU/1/12/755/008 EU/1/12/755/009 EU/1/12/755/010 EU/1/12/755/011 EU/1/12/755/012 EU/1/12/755/013 EU/1/12/755/014 EU/1/12/755/015 EU/1/12/755/016 EU/1/12/755/017 EU/1/12/755/018 EU/1/12/755/019 EU/1/12/755/020 EU/1/12/755/021 EU/1/12/755/022 EU/1/12/755/023 EU/1/12/755/024 EU/1/12/755/025 EU/1/12/755/026 EU/1/12/755/027
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ } Du kan finde yderligere information om Pioglitazon Actavis på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments.
Danish: Synsforstyrrelser er primært blevet indberettet tidligt i behandlingsforløbet og er relateret til ændringer i blodglucoseværdier.
English: If you have the impression that the effect of Pioglitazone Actavis is too weak, talk to your doctor.
Danish: Tal med lægen, hvis du har indtryk af, at effekten af Pioglitazon Actavis er for svag.
English: Investigations weight increased common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon
Danish: Undersøgelser øget vægt almindelig almindelig almindelig almindelig almindelig forhøjet kreatinkinase almindelig forhøjet laktatdehydrogenase ikke almindelig forhøjet alaninaminotransferase ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
English: Eye disorders visual disturbance common common uncommon macular oedema not known not known not known not known not known Ear and labyrinth disorders vertigo uncommon
Danish: Øjne synsforstyrrelser almindelig almindelig ikke almindelig makulaødem ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
English: Pioglitazone Actavis 45 mg
Danish: Pioglitazon Actavis 45 mg
English: Pioglitazone Actavis 30 mg
Danish: Pioglitazon Actavis 30 mg
English: What Pioglitazone Actavis contains - The active substance is pioglitazone.
Danish: - Det aktive stof er pioglitazon.
English: Pioglitazone Actavis 15 mg
Danish: Pioglitazon Actavis 15 mg
English: General disorders and administration site conditions oedema very common fatigue uncommon
Danish: Almene symptomer og reaktioner på administrationsstedet ødemer meget almindelig træthed ikke almindelig
English: - if you have heart failure or have had heart failure in the past.
Danish: Actavis (angivet i punkt 6), hvis du lider af hjertesvigt eller tidligere har haft hjertesvigt.
English: EU/1/12/755/001 [14 tablets] EU/1/12/755/002 [28 tablets] EU/1/12/755/003 [30 tablets] EU/1/12/755/004 [50 tablets] EU/1/12/755/005 [56 tablets] EU/1/12/755/006 [84 tablets] EU/1/12/755/007 [90 tablets] EU/1/12/755/008 [98 tablets] EU/1/12/755/009 [100 tablets]
Danish: EU/1/12/755/001 [14 tabletter] EU/1/12/755/002 [28 tabletter] EU/1/12/755/003 [30 tabletter] EU/1/12/755/004 [50 tabletter] EU/1/12/755/005 [56 tabletter] EU/1/12/755/006 [84 tabletter] EU/1/12/755/007 [90 tabletter] EU/1/12/755/008 [98 tabletter] EU/1/12/755/009 [100 tabletter]
English: Pioglitazone Actavis 30 mg tablets
Danish: Pioglitazon Actavis 30 mg tabletter
English: How to take Pioglitazone Actavis
Danish: Sådan skal du tage Pioglitazon Actavis
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Pioglitazon Actavis Fortæl lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: EU/1/12/755/019 [14 tablets] EU/1/12/755/020 [28 tablets] EU/1/12/755/021 [30 tablets] EU/1/12/755/022 [50 tablets] EU/1/12/755/023 [56 tablets] EU/1/12/755/024 [84 tablets] EU/1/12/755/025 [90 tablets] EU/1/12/755/026 [98 tablets] EU/1/12/755/027 [100 tablets]
Danish: EU/1/12/755/019 [14 tabletter] EU/1/12/755/020 [28 tabletter] EU/1/12/755/021 [30 tabletter] EU/1/12/755/022 [50 tabletter] EU/1/12/755/023 [56 tabletter] EU/1/12/755/024 [84 tabletter] EU/1/12/755/025 [90 tabletter] EU/1/12/755/026 [98 tabletter] EU/1/12/755/027 [100 tabletter]
English: EU/1/12/755/010 [14 tablets] EU/1/12/755/011 [28 tablets] EU/1/12/755/012 [30 tablets] EU/1/12/755/013 [50 tablets] EU/1/12/755/014 [56 tablets] EU/1/12/755/015 [84 tablets] EU/1/12/755/016 [90 tablets] EU/1/12/755/017 [98 tablets] EU/1/12/755/018 [100 tablets]
Danish: EU/1/12/755/010 [14 tabletter] EU/1/12/755/011 [28 tabletter] EU/1/12/755/012 [30 tabletter] EU/1/12/755/013 [50 tabletter] EU/1/12/755/014 [56 tabletter] EU/1/12/755/015 [84 tabletter] EU/1/12/755/016 [90 tabletter] EU/1/12/755/017 [98 tabletter] EU/1/12/755/018 [100 tabletter]
English: Pioglitazone Actavis 45 mg tablets are white, round, flat, bevelled, 8 mm in diameter and engraved with ‘TZ45' on one side.
Danish: Pioglitazon Actavis 45 mg tabletter er hvide, runde, flade, skråkantede, 8 mm i diameter og mærket med ”TZ45” på den ene side.
English: Pioglitazone Actavis 45 mg tablets pioglitazone
Danish: Pioglitazon Actavis 45 mg tabletter pioglitazon
English: Pioglitazone Actavis 30 mg tablets are white, round, flat, bevelled, 7 mm in diameter and engraved with ‘TZ30' on one side.
Danish: Pioglitazon Actavis 30 mg tabletter er hvide, runde, flade, skråkantede, 7 mm i diameter og mærket med ”TZ30” på den ene side.
English: Pioglitazone Actavis 15 mg tablets
Danish: Pioglitazon Actavis 15 mg tabletter
English: Pioglitazone Actavis 45 mg tablets
Danish: Pioglitazon Actavis 45 mg tabletter
English: Aurobindo Pharma B.V. Tel: +31 (0)35 542 99 33
Danish: Tel: +31 (0)35 542 99 33
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Actavis 45 mg tablets pioglitazone
Danish: LÆGEMIDLETS NAVN Pioglitazon Actavis 45 mg tabletter pioglitazon
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Actavis 30 mg tablets pioglitazone
Danish: LÆGEMIDLETS NAVN Pioglitazon Actavis 30 mg tabletter pioglitazon
English: What Pioglitazone Actavis is and what it is used for What you need to know before you take Pioglitazone Actavis How to take Pioglitazone Actavis Possible side effects
Danish: Hvis du holder op med at tage Pioglitazon Actavis For at opnå den ønskede virkning skal du tage Pioglitazon Actavis hver dag.
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Actavis 15 mg tablets pioglitazone
Danish: LÆGEMIDLETS NAVN Pioglitazon Actavis 15 mg tabletter pioglitazon
English: What Pioglitazone Actavis looks like and contents of the pack Pioglitazone Actavis 15 mg tablets are white, round, flat, bevelled, 5.5 mm in diameter and engraved with ‘TZ15' on one side.
Danish: Pioglitazon Actavis 15 mg tabletter er hvide, runde, flade, skråkantede, 5,5 mm i diameter og mærket med ”TZ15” på den ene side.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC,
Danish: • Udvalget behandlede henvisningen i henhold til artikel 30 i direktiv 2001/83/EF.
English: Septicaemia and meningitis
Danish: Septikæmi og meningitis
English: Overall summary of the scientific evaluation of Zinacef and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Zinacef og relaterede navne (se bilag I)
English: Zinacef was first approved in Europe in the early 1980's and is available as parenteral formulations.
Danish: Zinacef blev første gang godkendt i EU i i begyndelsen af 1980'erne og dispenseres som parenterale formuleringer.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.”
Danish: Officielle retningslinjer for hensigtsmæssig brug af antibakterielle midler bør følges.”
English: The studies were performed in a period in which acquired resistance was not a critical problem.
Danish: Undersøgelserne blev udført på et tidspunkt, da erhvervet resistens ikke var et kritisk problem.
English: • Intra-abdominal infections (see section 4.4).
Danish: • Intraabdominale infektioner (se afsnit 4.4)
English: A referral under Article 30(2) of Directive 2001/83/EC was therefore triggered to resolve these divergences and thus to harmonise the Product Information (PI) across the EU.
Danish: Der blev derfor indledt en henvisning i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF, med henblik på at fjerne disse divergenser og harmonisere produktoplysningerne i EU.
English: Gonorrhoea
Danish: Gonorré
English: “Zinacef is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth) (see sections 4.4 and 5.1).
Danish: “Zinacef a indiceret til behandling af nedenstående infektioner hos voksne og børn, herunder nyfødte (fra fødslen) (se afsnit 4.4 og 5.1).
English: Obstetric and gynaecological infections
Danish: Obstetriske og gynækologiske infektioner
English: The CHMP also noted that there are few treatment options available for pregnant women with pyelonephritis.
Danish: CHMP bemærkede desuden, at der kun findes få behandlingsalternativer til gravide kvinder med pyelonefritis.
English: In conclusion, the CHMP adopted the following harmonised indications and wording for Section 4.1:
Danish: Som konklusion vedtog CHMP følgende harmoniserede indikationer og ordlyd til afsnit 4.1:
English: Regarding the method of administration, the CHMP stated that Zinacef should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60 minutes, or by deep intramuscular injection.
Danish: Vedrørende administrationsmetode anførte CHMP, at Zinacef bør administreres enten ved intravenøs injektion i løbet af 3-5 minutter direkte i en vene, med dråbetæller eller drop i løbet af 30-60 minutter eller ved dyb intramuskulær injektion.
English: The CHMP recommended the removal of the option of parenteral-to-oral sequential therapy for all patients, due to the significant reduction in exposure to active drug when switching to the oral formulation.
Danish: CHMP anbefalede at lade muligheden for parenteral-til-oral sekvensterapi udgå for alle patienter på grund af den betydeligt ringere eksponering for aktivt stof efter overgang til den orale formulering.
English: The CHMP therefore concluded that there is enough data to support the indication in adults and that the adult efficacy data could be extrapolated to the paediatric population.
Danish: CHMP konkluderede derfor, at der er tilstrækkelige data til støtte for indikationen hos voksne, og at data vedrørende virkning hos voksne kan ekstrapoleres til den pædiatriske population.
English: Regarding meningitis, the CHMP noted that the majority of the studies identified H. influenzae, N. meningitidis, S. pneumonia and S. aureus (non-MRSA) as the predominant bacterial species, which does not reflect the present EU situation, where aerobic Gram-negative bacilli are increasingly important as causative agents.
Danish: Vedrørende meningitis konstaterede CHMP, at størstedelen af undersøgelserne udpegede H. influenzae, N. meningitidis, S. pneumonia og S. aureus (ikke-MRSA) som de dominerende bakteriearter, hvilket ikke afspejler den nuværende situation i EU, hvor aerobe gramnegative baciller har stigende ætiologisk betydning.
English: Cefuroxime exerts a bactericidal action by inhibiting bacterial enzymes necessary for cell-wall synthesis (peptidoglycan synthesis), thereby causing cell death.
Danish: Cefuroxim virker baktericidt ved at hæmme de bakterielle enzymer, der er nødvendige for syntesen af cellevæggen (peptidoglycan-syntese), og medfører derved celledød.
English: The CHMP reviewed the presented clinical studies but considered the data to be insufficient.
Danish: CHMP gennemgik de forelagte kliniske undersøgelser, men anså dataene for at være utilstrækkelige.
English: The CHMP agreed that neonates may be given a similar total daily dose as recommended for infants (30 to 100 mg/kg/day) but at a reduced daily frequency of 2 or 3 divided doses, due to the longer serum half-life.
Danish: CHMP tilsluttede sig, at der anvendes samme totale dagsdosis til nyfødte som anbefalet til små børn (30 til 100 mg/kg/dag), dog fordelt på kun to-tre doser dagligt på grund af den længere halveringstid i serum.
English: The CHMP noted the large amount of clinical experience supporting the use of cefuroxime in this indication.
Danish: CHMP noterede sig de omfattende kliniske erfaringer, der støtter anvendelsen af cefuroxim til denne indikation.
English: The CHMP reviewed the studies on septicaemia which were old, non-comparative and included small numbers of patients.
Danish: CHMP gennemgik undersøgelserne vedrørende septikæmi, som er gamle og ikke-sammenlignende og kun omfatter små antal patienter.
English: As the study demonstrated the non-inferiority of cefuroxime, the CHMP considered the indication to be acceptable.
Danish: Da undersøgelsen godtgjorde non-inferioritet af cefuroxim, fandt CHMP, at indikationen kunne godtages.
English: In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents.
Danish: Ved behandling og forebyggelse af infektioner, hvor der må forventes at forekomme anaerobe organismer, bør cefuroxim anvendes i kombination med passende antibiotika.
English: • Soft-tissue infections: cellulitis, erysipelas and wound infections.
Danish: • Bløddelsinfektioner: cellulitis, erysipelas og sårinfektioner.
English: The CHMP considered the indication to be acceptable for all populations.
Danish: CHMP fandt, at indikationen kan godtages for alle populationer.
English: The CHMP reviewed the submitted studies, the majority of which used cefuroxime in combination with probenecid rather than cefuroxime alone.
Danish: CHMP gennemgik de forelagte undersøgelser, hvoraf der i størstedelen blev anvendt cefuroxim i kombination med probenecid frem for cefuroxim alene.
English: Indication in neonates
Danish: Indikation hos nyfødte
English: Zinacef was included in the list of products for Summary of Product Characteristics (SmPC) harmonisation, due to divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product.
Danish: Zinacef blev sat på listen over produkter, der skal have opdateret produktresuméet, som følge af de divergerende afgørelser, der er truffet af medlemsstaterne ved godkendelse af produktet.
English: Regarding patients with hepatic impairment, the CHMP stated that hepatic dysfunction is not expected to affect the pharmacokinetics of cefuroxime.
Danish: For patienter med nedsat leverfunktion anførte CHMP, at nedsat leverfunktion ikke forventes at have indflydelse på farmakokinetikken af cefuroxim.
English: The CHMP reviewed the submitted data and considered the distributions of infections in the two largest submitted studies to be supportive of the proposed indication, although cefuroxime is not suitable for the treatment of infections caused by Gram-negative non-fermenting bacteria.
Danish: CHMP gennemgik de forelagte data og fandt, at fordelingen af infektioner i de to største forelagte undersøgelser støtter den foreslåede indikation, skønt cefuroxim ikke er velegnet til behandling af infektioner forårsaget af gramnegative, ikke-fermenterende bakterier.
English: The CHMP reviewed the dosage recommendations for each individual indication.
Danish: CHMP gennemgik dosisanbefalingerne for hver enkelt indikation.