FrancophonIA/ELRC3.0 huggingface dataset:
English: No trials have been conducted to investigate the pharmacokinetics of angiotensin II in renally impaired patients since the kidneys are not a major organ for angiotensin II metabolism or excretion.
Danish: Der er ikke udført forsøg til undersøgelse af angiotensin II's farmakokinetik hos patienter med nedsat nyrefunktion, da nyrerne ikke er væsentlige organer for angiotensin II's metabolisering eller udskillelse.
English: When initiating GIAPREZA, it is important to closely monitor blood pressure response and adjust dose accordingly.
Danish: Når indgivelse af GIAPREZA påbegyndes, er det vigtigt at fortage tæt overvågning af blodtrykket og justere dosis i henhold til blodtryksresponset.
English: Submission of study results:
Danish: Indsendelse af studieresultater ne: 30. juni
English: Discard the vial and any unused portion of the medicinal product after use.
Danish: Bortskaf hætteglasset og evt. ikke-anvendte rester af lægemidlet efter brug.
English: It is important to administer GIAPREZA at the lowest compatible dose to achieve or maintain adequate mean arterial pressure and tissue perfusion.
Danish: Det er vigtigt at administrere GIAPREZA i den lavest forenelige dosis for at opnå eller vedligeholde et passende gennemsnitligt arterietryk og tilstrækkelig vævsperfusion.
English: Concurrent venous thromboembolism prophylaxis (VTE) should be used unless contraindicated during treatment with GIAPREZA.
Danish: Samtidig profylakse mod venøs tromboemboli (VTE) bør anvendes under behandling med GIAPREZA, medmindre dette er kontraindiceret.
English: It is not known whether GIAPREZA can pass into breast milk.
Danish: Det er ukendt, om GIAPREZA udskilles i modermælk.
English: Down-titrate by gradual decrements of up to 15 ng/kg per minute, as needed, based on blood pressure, in order to avoid hypotension due to abrupt withdrawal (see section 4.4).
Danish: Foretag nedtitrering ved gradvise nedjusteringer på op til 15 ng/kg pr. minut, alt efter hvad der er relevant baseret på blodtrykket, for at undgå hypotension ved for hurtig seponering (se pkt.
English: Therefore, once underlying shock is sufficiently improved, a slow down-titration is recommended by gradual decrements of up to 15 ng/kg per minute, as needed, based on blood pressure (see sections 4.2 and 4.4).
Danish: Når det underliggende chok er tilstrækkeligt bedret, anbefales det derfor at foretage langsom nedtitrering ved gradvise nedjusteringer på op til 15 ng/kg pr. minut, alt efter hvad der er relevant baseret på blodtrykket (se pkt.
English: vasodilatory shock and associated severe acute kidney injury requiring renal replacement therapy to provide: (1) data on the effect of the product on morbidity events and organ perfusion with and adequate representation of European patients, (2) reassurance that there is no detrimental effect on mortality at day 28, (3) additional safety data about ischemic and thromboembolic events associated with the use of the product and to record clinical global impression of the response to treatment.
Danish: Virkningsstudie efter tilladelse til markedsføring (PAES): For at foretage yderligere undersøgelse af virkningen og sikkerheden ved Giapreza til behandling af refraktær hypotension hos voksne med septisk eller anden form for distributivt chok skal indehaveren af markedsføringstilladelsen udføre og fremsende resultaterne af et randomiseret, dobbeltblindet placebokontrolleret multicenter-studie hos voksne patienter med vasodilatorisk chok og dermed forbundet svær akut nyreskade, der kræver nyreerstatningsbehandling, således at følgende fremskaffes: (1) data om produktets effekt på morbiditetshændelser og organperfusion med tilstrækkelig repræsentation af europæiske patienter, (2) forsikring om, at der ikke er nogen ugunstig virkning, hvad angår dødelighed ved dag 28, (3) yderligere sikkerhedsdata, hvad angår iskæmi og tromboemboliske hændelser ved brug af produktet, samt registrering af det samlede kliniske indtryk af behandlingsresponset.
English: One or two millilitres of GIAPREZA must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection to achieve a final concentration of 5,000 ng/mL or 10,000 ng/mL (see Table 1).
Danish: Én eller to milliliter GIAPREZA skal fortyndes i en 0,9 %-natriumchloridopløsning til injektion (9 mg/ml) for at opnå en slutkoncentration på 5.000 ng/ml eller 10.000 ng/ml (se tabel 1).
English: There are no dose adjustments needed for patients with impairment of the function of the liver or kidneys.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med nedsat lever- eller nyrefunktion.
English: METHOD OF ADMINISTRATION IV use only after dilution
Danish: ADMINISTRATIONSMETODE Kun til intravenøs anvendelse efter fortynding
English: Of the 321 patients, 227 (71%) were receiving a baseline norepinephrine equivalent dose (NED) < 0.5 mcg/kg/min, 73 patients (23%) were receiving baseline NED ≥ 0.5 to
Danish: Af de 321 patienter fik 227 (71%) en baseline-ækvivalentdosis af noradrenalin på < 0,5 mikrogram/kg/min, 73 patienter (23 %) fik en baseline-ækvivalentdosis af noradrenalin på ≥ 0,5-< 1 mikrogram/kg/min, og 21 patienter (6 %) fik høje doser af vasopressorer (ækvivalentdosis af noradrenalin på ≥ 1,0 mikrogram/kg/min).
English: The clinical experience with GIAPREZA is limited to septic or other distributive shock.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Den kliniske erfaring med GIAPREZA er begrænset til septisk eller anden form for distributivt chok.
English: If you are given more GIAPREZA than you should GIAPREZA will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose.
Danish: GIAPREZA vil blive indgivet af en læge eller en sygeplejerske, så det er ikke sandsynligt, at du vil få en forkert dosis.
English: The major imbalance compared to placebo was in venous thromboembolism (6.1% vs 0%) (see section 4.8).
Danish: Den største forstyrrelse sammenholdt med placebo var venøs tromboemboli (6,1 % vs. 0 %) (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains angiotensin II acetate equivalent to 2.5 mg angiotensin II.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml koncentrat indeholder angiotensin II-acetat svarende til 2,5 mg angiotensin II.
English: 1 ml solution in a Type I glass vial with an aluminium over-seal, stopper (elastomeric), and plastic cap.
Danish: 1 ml opløsning i et type I-hætteglas med aluminiumsforsegling, prop (elastomer), og plasthætte.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIAPREZA 2.5 mg/mL sterile concentrate angiotensin II
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) GIAPREZA 2,5 mg/ml sterilt koncentrat angiotensin II
English: Dilute 1 or 2 ml of GIAPREZA in sodium chloride 9 mg/ml (0.9%) solution for injection to achieve a final concentration of 5,000 ng/ml or 10,000 ng/ml.
Danish: Fortynd 1 eller 2 ml GIAPREZA i en 0,9 %-natriumchloridopløsning til injektion (9 mg/ml) for at opnå en slutkoncentration på 5.000 ng/ml eller 10.000 ng/ml.
English: Posology and method of administration
Danish: Dosering og administration
English: 2 ml solution in a Type I glass vial with an aluminium over-seal, stopper (elastomeric), and plastic cap.
Danish: 2 ml opløsning i et type I-hætteglas med aluminiumsforsegling, prop (elastomer), og plasthætte.
English: GIAPREZA 2.5 mg/ml concentrate for solution for infusion angiotensin II
Danish: GIAPREZA 2,5 mg/ml koncentrat til infusionsvæske, opløsning angiotensin II
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 2.5 mg of angiotensin II (as acetate)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml indeholder 2,5 mg angiotensin II (som acetat)
English: Clear and colourless solution.
Danish: Klar, farveløs opløsning.
English: No special dose adjustment is required in patients with renal insufficiency or those with hepatic impairment (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis særskilt hos patienter med nedsat nyre- eller leverfunktion (se pkt.
English: As for other age groups, it is important to closely monitor blood pressure response and adjust dose accordingly.
Danish: Som hos andre aldersgrupper er det vigtigt at fortage tæt overvågning af blodtrykket og justere dosis i henhold til blodtryksresponset.
English: Each ml contains angiotensin II acetate equivalent to 2.5 mg angiotensin II.
Danish: Hver ml indeholder angiotensin II-acetat svarende til 2,5 mg angiotensin II.
English: NAME OF THE MEDICINAL PRODUCT GIAPREZA 2.5 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN GIAPREZA 2,5 mg/ml koncentrat til infusionsvæske, opløsning
English: A number of medicines may affect the way GIAPREZA works, such as: - Angiotensin converting enzyme (ACE) inhibitors (medicines used to lower blood pressure, with active substances whose name usually end in -pril).
Danish: Det gælder f.eks.: - ACE-hæmmere (angiotensinkonvertasehæmmere), som er lægemidler til sænkning af blodtrykket, der indeholder aktive stoffer, som typisk ender på -pril).
English: La Jolla Pharmaceutical II B.V. Herengracht 500
Danish: La Jolla Pharmaceutical II B.V.
English: In order to minimise adverse events derived from prolonged vasoconstriction, treatment should be withdrawn as soon as the underlying shock is sufficiently improved (see sections 4.2 and 4.4).
Danish: For at minimere bivirkningerne ved længerevarende vasokonstriktion bør behandlingen seponeres, når den underliggende choktilstand er tilstrækkeligt bedret (se pkt.
English: How GIAPREZA is used
Danish: Sådan skal du bruge GIAPREZA
English: As for other patient populations, it is important to closely monitor blood pressure response and adjust dose accordingly.
Danish: Som hos andre populationer er det vigtigt at fortage tæt overvågning af blodtrykket og justere dosis i henhold til blodtryksresponset.
English: Concentrate for solution for infusion 1 vial
Danish: Koncentrat til infusionsvæske, opløsning 1 hætteglas
English: What GIAPREZA looks like and contents of the pack GIAPREZA is presented as a concentrate for solution for infusion (sterile concentrate).
Danish: GIAPREZA fås som et koncentrat til infusionsvæske, opløsning (sterilt koncentrat).
English: Marketing Authorisation Holder La Jolla Pharmaceutical II B.V. Herengracht 500
Danish: Indehaver af markedsføringstilladelsen La Jolla Pharmaceutical II B.V.
English: ≥ 10 mmHg increase in MAP without an increase in baseline vasopressor therapy at 3 hours.
Danish: Det primære endepunkt var procentdelen af patienter, der opnåede enten en stigning i MAP på ≥ 75 mmHg eller en stigning i MAP på ≥ 10 mmHg uden en øgning af baseline-vasopressorterapien efter 3 timer.
English: In order to minimise the risk of adverse events derived from prolonged vasoconstriction, treatment with GIAPREZA should be withdrawn once underlying shock is sufficiently improved (see section 4.4 and 4.8).
Danish: For at minimere risikoen for bivirkninger ved længerevarende vasokonstriktion bør behandling med GIAPREZA seponeres, når den underliggende choktilstand er tilstrækkeligt forbedret (se pkt.
English: must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection prior to use.
Danish: GIAPREZA skal fortyndes i en 0,9 %-natriumchloridopløsning til injektion (9 mg/ml) inden anvendelse.
English: Peripheral ischaemia may be a consequence of the mechanism of action of GIAPREZA.
Danish: GIAPREZAs virkningsmekanisme kan forårsage perifer iskæmi.
English: Approximately one in every four patients experienced transient hypertension with the angiotensin II 20 ng/kg per minute starting dose in clinical trials (see section 4.8), thus needing dose down-titration.
Danish: I kliniske forsøg oplevede ca. én ud af fire patienter forbigående hypertension ved en startdosis af angiotensin II på 20 ng/kg pr. minut, og dosis skulle derfor nedtitreres (se pkt.
English: Discard prepared solution after 24 hours at room temperature or under refrigeration.
Danish: Efter opbevaring i 24 timer ved stuetemperatur eller i køleskab skal den fortyndede opløsning bortskaffes.
English: Impairment of liver or kidneys
Danish: Nedsat lever- eller nyrefunktion
English: GIAPREZA response rate
Danish: Responsrate for GIAPREZA
English: Two (1.2%) patients in the GIAPREZA arm experienced a fatal thromboembolic event compared with no patients in the placebo arm. Concurrent venous thromboembolism prophylaxis should be used unless contraindicated during treatment with GIAPREZA (see section 4.4).
Danish: Hos 2 patienter i GIAPREZA-gruppen (1,2 %) sås en tromboembolisk hændelse med dødelig udgang, sammenholdt med ingen patienter i placebogruppen.
English: How GIAPREZA is stored 6.
Danish: Sådan skal du bruge GIAPREZA 4.
English: One vial of 2 ml concentrate for solution for infusion contains 5 mg of angiotensin II.
Danish: Et hætteglas med 2 ml koncentrat til infusionsvæske, opløsning, indeholder 5 mg angiotensin II.
English: Approximately one in every four patients experienced transient hypertension with the angiotensin II 20 ng/kg/min starting dose in clinical trials (see section 4.8), thus needing dose downtitration.
Danish: I kliniske forsøg oplevede ca. én ud af fire patienter forbigående hypertension ved en startdosis af angiotensin II på 20 ng/kg/minut, og dosis skulle derfor nedtitreres (se pkt.
English: Vascular disorders
Danish: Fortyndet opløsning
English: One vial of 1 ml concentrate for solution for infusion contains 2.5 mg of angiotensin II.
Danish: Et hætteglas med 1 ml koncentrat til infusionsvæske, opløsning, indeholder 2,5 mg angiotensin II.
English: Your doctor should be told if you are breast-feeding before this medicine is given.
Danish: Hvis du ammer, skal du spørge lægen til råds, før du får dette lægemiddel.
English: Withdrawal of therapy
Danish: Seponering af behandlingen
English: Preparation of diluted solution
Danish: Klargøring af fortyndet opløsning
English: Vial strength
Danish: Hætteglasstyrke
English: How to store GIAPREZA
Danish: Hvis du har fået for meget GIAPREZA
English: It is important that both men and women read the information.
Danish: Det er vigtigt at både mænd og kvinder læser informationen.
English: Yes (for all three parameters listed above)
Danish: Ja (til alle tre parametre ovenfor)
English: Date of first authorisation: 15 January 2015 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 15 januar 2015 Dato for seneste fornyelse:
English: If you feel tired, do not drive or use any machines.
Danish: Hvis du føler dig træt, må du ikke køre bil eller betjene maskiner.
English: - have diabetes.
Danish: - har diabetes.
English: Use with caution.
Danish: Anvendes med forsigtighed.
English: ANTIBIOTICS (SYSTEMIC ADMINISTRATION)
Danish: ANTIBIOTIKA (SYSTEMISK ADMINISTRATION)
English: You will take Exviera for 8, 12 or 24 weeks.
Danish: Du skal tage Exviera i 8, 12 eller 24 uger.
English: • Risk management plan (RMP)
Danish: • RisikostyringsPlan (RMP)
English: Number of Responders at the End of Treatment
Danish: Antal respondenter ved afslutningen af behandlingen
English: The final study report shall be submitted by:
Danish: Den endelige studierapport skal indsendes i:
English: See sections 4.8 and 5.1 for additional information.
Danish: 4.8 og 5.1 for yderligere oplysninger.
English: Seven metabolites were identified in plasma.
Danish: Syv metabolitter blev identificeret i plasma.
English: • Worsening liver problems.
Danish: • Forværrede leverproblemer.
English: • Do not chew, crush or break the tablets as they may have a bitter taste.
Danish: • Du må ikke tygge, knuse eller brække tabletterne, da de kan have en bitter smag.
English: Ribavirin may cause severe birth defects.
Danish: Ribavirin kan forårsage alvorlige fødselsdefekter.
English: EFFECT Cmax
Danish: VIRKNING Cmax
English: Treatment duration 12 weeks
Danish: Behandlingsvarighed 12 uger
English: There is no pharmacokinetic information in patients >75 years.
Danish: Der foreligger ingen farmakokinetiske oplysninger for patienter over 75 år.
English: Depression or psychiatric illness
Danish: Depression eller psykisk sygdom
English: This is so that your doctor can:
Danish: Derved kan lægen:
English: b. N=66 for the NS5B target.
Danish: b. N = 66 for NS5B-målet.
English: Your doctor will tell you how long your treatment will last.
Danish: Lægen vil fortælle dig, hvor længe behandlingen skal vare.
English: Frequency not known: cannot be estimated based on available data
Danish: Hyppighed ukendt: kan ikke estimeres udfra tilgængelige data.
English: Keep the medicine pack with you so you can easily describe what you have taken.
Danish: Tag Exviera-pakningen med, så du let kan beskrive, hvad du har taget.
English: Medicinal Product/ Possible Mechanism of Interaction
Danish: Lægemiddel/ mulig interaktionsmekanisme
English: Patients should be instructed not to take a double dose.
Danish: Patienterne skal have at vide, at de ikke må tage en dobbeltdosis.
English: The film-coated tablets are for oral use.
Danish: De filmovertrukne tabletter er til oral anvendelse.
English: It is important not to miss a dose of this medicine.
Danish: Det er vigtigt ikke at glemme en dosis af dette lægemiddel.
English: The combination was not linked to any particular safety issues in a limited set of patients treated for 12-24 weeks.
Danish: Kombinationen blev ikke forbundet med nævneværdige problemer hos en begrænset gruppe patienter, der blev behandlet i 12-24 uger.
English: HBV screening should be performed in all patients before initiation of treatment.
Danish: HBV-screening bør udføres på alle patienter før behandlingsstart.
English: The adverse reactions are listed below by system organ class and frequency.
Danish: Bivirkningerne er opstillet nedenfor efter systemorganklasse og hyppighed.
English: • Decide what other medicines you should take with Exviera and for how long.
Danish: • beslutte, hvilke andre lægemidler du skal tage sammen med Exviera, og i hvor lang tid
English: Effects of food
Danish: Virkningen af mad
English: How much to take
Danish: Så meget skal du tage
English: Laboratory parameters
Danish: Laboratorieparametre
English: • Anaemia (low number of red blood cells).
Danish: • anæmi (nedsat antal røde blodlegemer)
English: The type of food is not important.
Danish: Det er ligegyldigt hvilken slags mad.
English: • Confirm if your treatment has worked and if you are free of the hepatitis C virus.
Danish: • kontrollere, om din behandling virker, og om du er fri for hepatitis C-virus
English: e. Observed in combination in 6% (4/67) of the subjects.
Danish: e. Observeret i kombination hos 6 % (4/67) af forsøgspersonerne.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendix V. Ved at indberette bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: There are very limited data from the use of dasabuvir in pregnant women.
Danish: Der er meget begrænsede data fra anvendelse af dasabuvir til gravide kvinder.
English: • If you or your partner becomes pregnant during treatment with Exviera and ribavirin or in the months that follow, you must contact your doctor immediately.
Danish: • Hvis du eller din partner bliver gravide under behandlingen med Exviera og ribavirin eller i de efterfølgende måneder, skal du straks kontakte din læge.
English: Activity in cell culture and biochemical studies
Danish: Aktivitet i cellekulturanalyser og biokemiske studier
English: 67061 Ludwigshafen GERMANY
Danish: 67061 Ludwigshafen Tyskland
English: Your doctor will test your blood before, during and after your treatment with Exviera.
Danish: Din læge vil undersøge dit blod før, under og efter din behandling med Exviera.
English: 61% had prior HCV treatment experience before transplant.
Danish: 61% var tidligere HCV-behandlingserfarne inden transplantation.
English: Efficacy analyses performed on other parts of the study demonstrated similarly high SVR12 rates.
Danish: Effektanalyser udført på andre dele af studiet viste tilsvarende høje SVR12-rater.
English: • Swallow the tablets whole with water.
Danish: • Synk tabletterne hele med vand.
English: Race or ethnicity
Danish: Race og etnisk oprindelse
English: • You or your partner must use an effective method of contraception during treatment.
Danish: • Du eller din partner skal bruge sikker præventionsmetode under behandlingen.
English: *Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Danish: til fortynding af blodet *Det kan være nødvendigt for din læge at øge hyppigheden af dine blodprøver for at kontrollere, hvor godt dit blod kan størkne.
English: Sirolimus blood concentrations should be monitored every 4 to 7 days until 3 consecutive trough levels have shown stable concentrations of sirolimus.
Danish: Koncentrationen af sirolimus i blodet skal overvåges hver 4. til 7. dag, indtil 3 på hinanden følgende niveauer har vist stabil koncentration af sirolimus.
English: No adverse effects on behaviour, reproduction or development of offspring were reported.
Danish: Der blev ikke rapporteret om uønskede virkninger på adfærd, reproduktion eller afkommets udvikling.
English: Expected:
Danish: Forventet:
English: Use with tacrolimus, sirolimus and everolimus
Danish: Brug med tacrolimus, sirolimus og everolimus
English: Persistence of resistance-associated substitutions
Danish: Resistensrelaterede substitutioners persistens
English: See the section on contraception below.
Danish: Se punktet om prævention nedenfor.
English: Expected: ↓ S-mephenytoin
Danish: Forventet: ↓ S-mephenytoin
English: The doctor may need to change your dose of these medicines.
Danish: Lægen vil vurdere, om din dosis af disse lægemidler skal ændres.
English: The use of Exviera in children and adolescents has not yet been studied.
Danish: Anvendelsen af Exviera hos børn og unge er endnu ikke undersøgt.
English: The lack of detection of virus containing a resistance-associated substitution does not indicate that the resistant virus is no longer present at clinically significant levels.
Danish: Manglende detektering af virus indeholdende en resistensrelateret substitution er ikke ensbetydende med, at det resistente virus ikke længere er til stede i klinisk signifikant omfang.
English: This is not an exclusive list.
Danish: Listen er ikke udtømmende.
English: Do not give Exviera to children and adolescents under 18 years of age.
Danish: Giv ikke Exviera til børn og unge under 18 år.
English: C12:= concentration at 12 hours following single dose of everolimus.
Danish: C12: = koncentration ved 12 timer efter en enkelt dosis af everolimus
English: Genotype-specific activity
Danish: Genotypespecifik aktivitet
English: Early discontinuation may result in drug resistance, but implications for future therapy are not known.
Danish: Tidlig seponering kan medføre lægemiddelresistens, men betydningen for fremtidig behandling er ikke kendt.
English: Changes in selected laboratory parameters are described in Table 4.
Danish: Ændringer i udvalgte laboratorieparametre fremgår af tabel 4.
English: For patients with cirrhosis:
Danish: For patienter med cirrose:
English: Main demographics in TURQUOISE-III Characteristics
Danish: Vigtigste demografiske karakteristika i TURQUOISE-III Karateristika
English: • If you have moderate to severe liver problems other than hepatitis C.
Danish: • hvis du har andre moderate til alvorlige leverproblemer end hepatitis C.
English: Patients should be instructed to swallow the tablets whole (i.e. patients should not chew, break or dissolve the tablet).
Danish: Patienterne skal have at vide, at de skal sluge tabletterne hele (dvs. at de ikke må tygge, dele eller opløse dem).
English: Your doctor will talk with you about which of these medicines to take with Exviera.
Danish: Din læge vil tale med dig om, hvilket af disse lægemidler du skal tage sammen med Exviera.
English: The recommended tacrolimus dosing is 0.5 mg every 7 days.
Danish: Den anbefalede tacrolimus dosering er 0,5 mg hver 7. dag.