FrancophonIA/ELRC3.0 huggingface dataset:
English: Upon consideration of all available data, the CHMP adopted an opinion for lumiracoxib on 23 June 2005 recommending the maintenance of the Marketing Authorisations for lumiracoxib containing medicinal products in the indications stated in the Summary of Product Characteristics as set out in Annex III.
Danish: Heri anbefalede CHMP at opretholde markedsføringstilladelserne for lægemidler indeholdende lumiracoxib for indikationerne i produktresuméet, jf. bilag III.
English: EU/2/02/035/007 SevoFlo 100% Inhalation vapour, liquid
Danish: EU/2/02/035/007 SevoFlo 100 % Væske til inhalationsdamp
English: Dogs and cats.
Danish: Hunde og katte Inhalation
English: Inhalation use Bottle (polyethylene naphthalate) with Quik-Fil (II) closure
Danish: Flaske af polyethylent erephthalat (PET) med Quik-Fil-låg (II)
English: 1 bottle Not applicable.
Danish: 1 flaske
English: Target species
Danish: Ikke relevant
English: Further information on Giapreza can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/giapreza
Danish: Yderligere information om Giapreza findes på agenturets websted under: https://www.ema.europa.eu/en/medicines/human/EPAR/giapreza
English: The dose depends on the patient's weight and should be adjusted according to the patient's blood pressure.
Danish: Dosen afhænger af patientens vægt og bør justeres efter patientens blodtryk.
English: The medicine should be prescribed by a physician experienced in the treatment of shock and is for use in a hospital setting.
Danish: Lægemidlet bør ordineres af en læge med erfaring i behandling af chok og er beregnet til anvendelse på hospitaler.
English: The rise in blood pressure is expected to help prevent organ damage and reduce the number of deaths from this condition.
Danish: Stigningen i blodtrykket forventes at bidrage til at forebygge organskader og nedbringe antallet af dødsfald som følge af denne sygdom.
English: As for all medicines, data on the use of Giapreza are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Giapreza løbende overvåget.
English: The active substance in Giapreza, angiotensin II, is the same as a hormone that the body produces.
Danish: Det aktive stof i Giapreza, angiotensin II, er det samme som et hormon, kroppen producerer.
English: What measures are being taken to ensure the safe and effective use of Giapreza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Giapreza?
English: After 3 hours, 70% of patients treated with Giapreza in addition to standard treatments had their average arterial blood pressure rise to above 75 mmHg (an acceptable level) or by at least 10 mmHg, compared with 23% of patients treated with placebo (a dummy treatment) and standard treatments.
Danish: Efter 3 timer var der hos 70 % af de patienter, der blev behandlet med Giapreza i tillæg til standardbehandlinger, en gennemsnitlig stigning i det arterielle blodtryk med over 75 mmHg (et acceptabelt niveau) eller med mindst 10 mmHg sammenlignet med 23 % af de patienter, der fik placebo (en uvirksom behandling) og standardbehandlinger.
English: It is used when other treatments for raising blood pressure have not worked and contains the active substance angiotensin II.
Danish: Det anvendes, når andre behandlinger til forøgelse af blodtrykket ikke har virket, og indeholder det aktive stof angiotensin II.
English: Other information about Giapreza
Danish: Andre oplysninger om Giapreza
English: The company that markets Giapreza will carry out a study to further investigate the effectiveness and safety of Giapreza, including whether the medicine could prevent damage to organs and affect how long patients live.
Danish: Virksomheden, der markedsfører Giapreza, vil gennemføre et studie for yderligere at undersøge Giaprezas virkning og sikkerhed, herunder om lægemidlet kan forebygge skader på organer og påvirke, hvor længe patienterne lever.
English: Giapreza is a medicine used in adults with dangerously low blood pressure (a condition known as shock).
Danish: Giapreza er et lægemiddel, der anvendes til voksne med faretruende lavt blodtryk (en tilstand, der kaldes chok).
English: It is given as a continuous infusion (‘drip') into a vein.
Danish: Det gives ved konstant infusion (drop) i en vene.
English: Angiotensin II increases blood pressure by narrowing blood vessels and releasing another hormone (aldosterone) that increases the volume of blood circulating in the body.
Danish: Angiotensin II øger blodtrykket ved at begrænse blodkarrene og frigive et andet hormon (aldosteron), som øger mængden af blod, der cirkulerer i kroppen.
English: A main study involving 344 patients in shock has shown that Giapreza is effective at raising blood pressure when other treatments have not worked.
Danish: Et hovedstudie, hvori der indgik 344 patienter med chok, har vist, at Giapreza er effektivt til at øge blodtrykket, når andre behandlinger ikke har virket.
English: The European Medicines Agency therefore decided that Giapreza's benefits are greater than its risks and that it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Giapreza opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The most common side effects with Giapreza (which may affect more than 1 in 10 people) are thromboembolic events (problems due to clots in blood vessels) and short-lived high blood pressure.
Danish: De hyppigste bivirkninger ved Giapreza (som kan forekomme hos mere end 1 ud af 10 personer) er tromboemboliske hændelser (problemer som følge af blodpropper i blodkarrene) og et kortvarigt højt blodtryk.
English: For more information about using Giapreza, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Giapreza, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Why is Giapreza authorised in the EU?
Danish: Hvorfor er Giapreza godkendt i EU?
English: Side effects reported with Giapreza are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Giapreza vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Giapreza and why it is authorised in the EU
Danish: Oversigt over Giapreza, og hvorfor det er godkendt i EU
English: The side effects of Giapreza were similar to those of standard treatments and were considered manageable.
Danish: Bivirkningerne ved Giapreza svarede til dem, der var ved standardbehandlinger, og ansås for at være håndterbare.
English: The main study showed that adding Giapreza to standard treatment was effective in increasing average blood pressure in patients in shock.
Danish: Hovedstudiet viste, at tilføjelse af Giapreza til standardbehandlingen var effektiv til at øge det gennemsnitlige blodtryk hos patienter.
English: What is Giapreza and what is it used for?
Danish: Hvad er Giapreza, og hvad anvendes det til?
English: What are the risks associated with Giapreza?
Danish: Hvilke risici er der forbundet med Giapreza?
English: For the full list of side effects and restrictions with Giapreza, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Giapreza fremgår af indlægssedlen.
English: How is Giapreza used?
Danish: Hvordan anvendes Giapreza?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Giapreza have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Giapreza.
English: What benefits of Giapreza have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Giapreza?
English: How does Giapreza work?
Danish: Hvordan virker Giapreza?
English: Children (< 18 years)
Danish: Børn (<18 år)
English: Therefore, follow the specific dosage recommendations for each formulation.
Danish: Følg derfor de specifikke doseringsanbefalinger for hver formulering.
English: - if you have or have ever had liver problems.
Danish: • hvis du har eller nogensinde har haft problemer med leveren.
English: The reason for this time-dependency is not completely understood.
Danish: Årsagen til denne tidsafhængighed er ikke helt kendt.
English: These findings are not necessarily indicative of a potential for functional changes in humans.
Danish: Disse fund indikerer ikke nødvendigvis et potentiale for funktionelleforandringer hos mennesker.
English: Supportive care may be considered.
Danish: Understøttende behandling bør overvejes.
English: You may need to have blood tests while you are taking this medicine.
Danish: Det kan være nødvendigt, at du får taget blodprøver, mens du tager dette lægemiddel.
English: However, this was not a prospective, randomised controlled study and so all comparisons with the external control group should be viewed with caution.
Danish: Dette var imidlertid ikke et prospektivt randomiseret kontrolleret studie, ogderfor skal alle sammenligninger med den eksterne kontrolgruppe vurderes med forsigtighed.
English: Each dose may be taken without regard to food intake.
Danish: Hver dosis kan tages uden hensyn til fødeindtagelse.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det muliggør løbendeovervågning af benefit/risk-forholdet for lægemidlet.
English: This is because small amounts may pass into breast milk.
Danish: Dette skyldes, at små mængder kan udskilles i mælken.
English: If this happens, do not drive or use any tools or machines and contact your doctor.
Danish: Hvis dette sker, skal du undlade at køre bil, bruge værktøj eller betjene maskiner, og du skal kontakte din læge.
English: - Tablets may be taken with or without food.
Danish: • Tabletter kan indtages med eller uden mad.
English: Safety data mainly derive from studies with the oral suspension.
Danish: Sikkerhedsdata stammer hovedsaglig fra studier med den orale suspension.
English: It is used to prevent and treat many different fungal infections.
Danish: Det anvendes til at forebygge og behandle mange forskelligesvampeinfektioner.
English: Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Danish: De foreliggende data erbeskrevet i pkt.5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørendedosering.
English: The length of treatment may depend on the type of infection that you have and may be individually adapted for you by your doctor.
Danish: Varigheden af behandlingen kan afhænge af, hvilken type infektion du har, og din læge kan tilpasse behandlingen personligt til dig.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddelfremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv2001/83/EF,og alle efterfølgende opdateringer offentliggjort på den europæiske webportal forlægemidler.
English: No data are available for the tablet formulation.
Danish: Der foreligger ingen data for tabletformuleringen.
English: Chromoblastomycosis/Mycetoma
Danish: Chromoblastomykose/mycetoma
English: The elimination half-life (t1/2) was prolonged from approximately 27 hours up to ~43 hours in respective groups.
Danish: Eliminationshalveringstiden (t1/2)blev forlænget fra ca. 27 timer op til ~43 timer i de respektive grupper.
English: Administration of other azoles has been associated with increases in digoxin levels.
Danish: Administration af andre azoler har været associeret med stigning i digoxinniveauer.
English: A correlation between total medicinal product exposure divided by MIC (AUC/MIC) and clinical outcome was observed.
Danish: Der blev observeret en sammenhæng mellem den samlede lægemiddeleksponering divideret med MIC(AUC/MIC) og det kliniske resultat.
English: Budapest, 1045, HUNGARY
Danish: Budapest, 1045, Ungarn
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1379/001-004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1379/001-004
English: The critical ratio for subjects with Aspergillus infections was ~200.
Danish: Det kritiske forhold for forsøgspersoner med Aspergillusinfektioner var ~200.
English: A higher incidence of adverse reactions cannot be ruled out.
Danish: En højere forekomst af bivirkninger kan ikke udelukkes.
English: This belongs to a group of medicines called “antifungals”.
Danish: Det hører til en gruppe af lægemidler, som kaldes ” svampemidler”.
English: Clinical outcomes were compared with those in an external control group derived from a retrospective review of medical records.
Danish: De kliniske resultater blev sammenlignet med resultaterfra en ekstern kontrolgruppe udledt fra en retrospektiv gennemgang af medicinske journaler.
English: Q4 pCav: predicted Cav
Danish: K4 pCav: formodet Cav
English: Recommended dose is shown in Table 1.
Danish: Anbefalet dosering er vist i tabel1.
English: Monitoring of glucose concentrations is recommended in diabetic patients.
Danish: Monitorering af glucosekoncentrationer hos diabetespatienter anbefales.
English: See Section 4 for more information
Danish: Se punkt 4 for yderligere oplysninger.
English: This medicine works by killing or stopping the growth of some types of fungi that can cause infections.
Danish: Lægemidlet virker ved at dræbe eller stoppe væksten af nogle typer svampe, som kan forårsageinfektioner.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OGEFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Some azoles have been associated with prolongation of the QTc interval.
Danish: Nogle azoler har været forbundet med forlængelse af QTc-intervallet.
English: There are currently insufficient data to set clinical breakpoints for other Candida species.
Danish: Der er for tiden utilstrækkelige data til at fastsætte kliniske grænseværdier for andre Candida-arter.
English: Unbound concentrations were not determined and it cannot be excluded that there is a larger increase in unbound posaconazole exposure than the observed 60% increase in total AUC.
Danish: Ubundne koncentrationer blev ikke bestemt, og det kan ikke udelukkes, at der er en større stigning i eksponeringen for ubundet posaconazolend den observerede stigning på 60% i totalt AUC.
English: ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAGII A. FREMSTILLERE ANSVARLIGE FORBATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGERVEDRØRENDEUDLEVERINGOG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FORMARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MEDHENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AFLÆGEMIDLET
English: d: All randomized e: All treated
Danish: d: Alle randomiserede patienter e: Alle behandlede patienter
English: No adverse reactions were noted by the investigator.
Danish: Der blev ikke observeret nogen bivirkninger af investigator.
English: psychotic disorder, depression
Danish: Psykotiske tilstande, depression
English: There are limited pharmacokinetic data in patients with severe gastrointestinal dysfunction (such as severe diarrhoea).
Danish: Der er begrænsede farmakokinetiske data for patienter med alvorlig gastrointestinal dysfunktion (såsom alvorlig diarré).
English: Package leaflet: Information for the user
Danish: Indlægsseddel:Informationtilbrugeren
English: allergic reaction
Danish: Allergisk reaktion
English: - if you develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of this medicine.
Danish: • hvis du udvikler alvorlig diarré eller kaster op, da disse forhold kan begrænse virkningen afdettelægemiddel.
English: The tablets should be swallowed whole with water and should not be crushed, chewed, or broken.
Danish: Tabletterne skal synkes hele med vand og må ikke knuses, tygges ellerknækkes.
English: The safety profile in these patients < 18 years of age appears similar to the safety profile observed in adults.
Danish: Sikkerhedsprofilen for disse patienter <18 år synes at ligne den sikkerhedsprofil, som blev observeret hos voksne.
English: Gastrointestinal dysfunction
Danish: Gastrointestinal dysfunktion
English: Reproduction, peri- and postnatal development studies were conducted in rats.
Danish: Der er blevet udført studier af reproduktion samt peri-og postnatal udvikling hos rotter.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known.
Danish: Bivirkningstabel Inden fororgansystemklasseerbivirkningerne anført under overskrifter for hyppighed ved brug affølgendekategorier:megetalmindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig(≥1/1.000 til <1/100); sjælden (≥ 1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt.
English: fluconazole, itraconazole or voriconazole.
Danish: fluconazol, itraconazol eller voriconazol.
English: 4.6 Fertility, pregnancy and lactation
Danish: 4.6 Fertilitet,graviditet og amning
English: Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin).
Danish: Patientbehandlingen bør omfatte laboratoriemæssig evaluering af leverfunktionen (især leverfunktionstest og bilirubin).
English: The majority (377/600, [63%]) of patients included had Acute Grade 2 or 3 or chronic extensive (195/600, [32.5%])
Danish: Størstedelen (377/600, [63 %]) af de inkluderede patienter havde akut GVHD af grad 2 eller 3 eller kronisk ekstensivGVHD(195/600, [32,5 %]) ved studiestart.
English: See Table 5 and 6 for results from both studies.
Danish: Se tabel5 og6 forresultater fra begge studier.
English: Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy.
Danish: Forhøjedeleverfunktionsværdier var generelt reversible ved afbrydelse af behandlingen, og i nogle tilfælde normaliseredes disse værdier uden afbrydelse af behandling.
English: Children Posaconazole Accord should not be used in children (17 years of age and younger).
Danish: Brug til børn Posaconazole Accord må ikkeanvendes tilbørn (17 år eller yngre).
English: Pulmonary phospholipidosis resulting in dilatation and obstruction of the alveoli was observed in the 2-year study in rats.
Danish: Pulmonal fosfolipidose, der resulterede i dilatation og obstruktion af alveolerne, blev observeret i et 2årigt studie med rotter.
English: Results from clinical studies in prophylaxis of Invasive Fungal Infections Study
Danish: Resultater fra kliniske studier tilforebyggelse af invasive svampeinfektioner Studie
English: c: In 1899, this was the period from randomization to 100 days post-randomization; in 316 it was the period from the baseline day to 111 days post-baseline.
Danish: c: I 1899 var det perioden fra randomisering til 100dage efter randomisering; i 316 var det perioden fra baseline-dagen til111dage efterbaseline.
English: TreatmentInvasive Aspergillosis Study 0041
Danish: BehandlingInvasiv Aspergillosis Studie 0041
English: Most of the cases of aspergillosis were considered to be refractory to prior therapy in both the posaconazole group (88%) and in the external control group (79%).
Danish: De fleste tilfælde af aspergillose blevvurderet som værende refraktære over for tidligere terapi både i posaconazolgruppen (88%) og i den eksterne kontrolgruppe (79 %).
English: The excreted metabolites in urine and faeces account for approximately 17% of the administered radiolabelled dose.
Danish: De metabolitter, der udskilles i urin og fæces, udgør ca. 17% af den administrerederadioaktivtmærkededosis.
English: - Do not crush, chew, break or dissolve the tablet.
Danish: • Du må ikke knuse, tygge, brække eller opløse tabletten.
English: Therefore, trough concentrations that fall in the upper part of the usual therapeutic range should be targeted and careful attention should be paid to clinical signs and symptoms, laboratory parameters and tissue biopsies.
Danish: Dalkoncentrationer af sirolimus, der ligger i den øvre del af det sædvanlige terapeutiske indeks, bør derfor tilstræbes, og der bør rettes særligopmærksomhed mod kliniske tegn og symptomer,laboratorieparametre og vævsbiopsier.
English: No pharmacokinetic data are available from paediatric patients less than 8 years of age.
Danish: Derforeligger ingen farmakokinetiske data fra børn under 8 år.
English: adrenal insufficiency, blood gonadotropin decreased
Danish: Adrenal insufficiens, nedsat blod gonadotropin
English: Endocrine disorders Rare:
Danish: Det endokrine system Sjælden
English: If you are already taking rifabutin, you will need a blood test and you will need to look out for some possible side effects of rifabutin.
Danish: Hvis du allerede tager rifabutin, skal du have taget en blodprøve, og du skal væreopmærksompå mulige bivirkningerafrifabutin.
English: The excretion of posaconazole in human breast milk has not been investigated.
Danish: Udskillelsen af posaconazol i human mælk er ikke undersøgt.
English: hypotension, vasculitis
Danish: Hypotension, vaskulitis
English: Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. That expiry date refers to the last day of that month.
Danish: Brugikke lægemidletefter den udløbsdato, der står på blister eller karton efter EXP. Udløbsdatoen erdensidstedag i dennævntemåned.
English: Among eighteen patients who were intolerant or had infections refractory to amphotericin B or itraconazole, seven patients were classed as responders.
Danish: Blandt 18 patienter, som ikke tålte eller havde infektioner, der var refraktære over for amphotericin B eller itraconazol, blev 7 patienter klassificeret som havende respons (responders).
English: Pharmacokinetic modeling with an oral tablet formulation suggests that patients weighing greater than 120 kg may have lower posaconazole exposure.
Danish: Farmakokinetiske modeller med en oral tabletformuleringtyder på, at patienter, der vejer mere end120 kg, kan have lavere eksponering for posaconazol.
English: No clinically relevant changes in the mean QTc (Fridericia) interval from baseline were observed.
Danish: Der blev ikkeobserveret klinisk relevante forandringer i det gennemsnitlige QTc (Fridericia)intervaliforholdtilbaseline.
English: 1 Includes other less common species or species unknown
Danish: 2Inkluderer andre mindre almindeligeellerukendtearter
English: Midazolam and other benzodiazepines
Danish: Midazolam og andre benzodiazepiner
English: Pharmacokinetic / Pharmacodynamic relationships
Danish: Farmakokinetiske/farmakodynamiske forhold
English: Based on Kaplan-Meier estimates, the probability of survival up to day 100 after randomization, was significantly higher for posaconazole recipients; this survival benefit was demonstrated when the analysis considered all causes of death (P=0.0354) as well as IFI-related deaths (P = 0.0209).
Danish: Baseret på KaplanMeier-estimater var sandsynligheden for at overleve frem til dag100 efter randomisering signifikanthøjere for modtagere af posaconazol; denne overlevelsesfordel blev påvist, da analysen betragtede død af alle årsager (P=0,0354) såvel som dødsfald med relation til IFI (P=0,0209).