FrancophonIA/ELRC3.0 huggingface dataset:
English: The plasma half-life of angiotensin II administered intravenously is less than one minute.
Danish: Plasmahalveringstiden for angiotensin II administreret intravenøst er under ét minut.
English: LIST OF EXCIPIENTS Excipients: mannitol, water for injections, sodium hydroxide, hydrochloric acid
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: mannitol, vand til injektionsvæsker, natriumhydroxid, saltsyre
English: It is not known whether GIAPREZA can affect fertility.
Danish: Det vides ikke, om GIAPREZA kan have indvirkning på frugtbarheden.
English: In a cardiovascular safety pharmacology study in normotensive dogs, GIAPREZA elicited increased heart rate, systemic vascular resistance, left ventricular systolic pressure and left ventricular diastolic pressure, and PR interval prolongation.
Danish: I et farmakologisk studie til undersøgelse af den kardiovaskulære sikkerhed hos normotensive hunde medførte GIAPREZA øget hjertefrekvens, systemisk vaskulær modstand, systolisk tryk i venstre ventrikel, diastolisk tryk i venstre ventrikel og forlænget PR-interval.
English: GIAPREZA should only be administered by continuous intravenous infusion under close monitoring of haemodynamics and end-organ perfusion.
Danish: GIAPREZA bør kun administreres ved kontinuerlig intravenøs infusion under tæt overvågning af hæmodynamik og slutorganperfusion.
English: Patients with active bleeding, mesenteric ischaemia, liver failure and MELD score of ≥ 30, CV SOFA score ≤ 3 and patients with extensive burns were also excluded.
Danish: Patienter med aktiv blødning, mesenteriel iskæmi, leversvigt og en MELD-score på ≥ 30, en CV SOFA-score på ≤ 3 samt patienter med omfattende brandsår blev også ekskluderet.
English: Infusion bag size (mL)
Danish: Infusionsp osens størrelse (ml)
English: GIAPREZA is recommended to be administered via a central venous line.
Danish: Det anbefales, at GIAPREZA administreres gennem et centralt venekateter.
English: EXP: After dilution, use immediately.
Danish: EXP: Anvendes med det samme efter fortynding.
English: Do not exceed 80 ng/kg per minute during the first 3 hours of treatment.
Danish: Dosis må ikke overskride 80 ng/kg pr. minut under de første 3 timers behandling.
English: Your doctor will continue to assess your response and will adjust the dose accordingly up to a maximum of 80 ng per kilogram each minute during the first 3 hours of treatment.
Danish: Lægen vil blive ved med at overvåge dit blodtryk og justere dosen ud fra din reaktion på behandlingen, op til maksimalt 80 ng pr. kilo pr. minut i de første 3 timer af behandlingen.
English: Your doctor will monitor your blood pressure and adjust your dose as needed.
Danish: Lægen vil overvåge dit blodtryk og om nødvendigt justere din dosis.
English: There is limited information about the effects of GIAPREZA during pregnancy.
Danish: Der er kun begrænsede data om GIAPREZAs virkning under graviditet.
English: Store in a refrigerator (2-8 °C).
Danish: Opbevares i køleskab (2-8 °C).
English: Concentrate for solution for infusion (sterile concentrate).
Danish: Koncentrat til infusionsvæske, opløsning (sterilt koncentrat).
English: GIAPREZA has only been tested in people with septic and distributive shock.
Danish: GIAPREZA er kun testet hos patienter med septisk og distributivt chok.
English: At the time of study drug administration, 97% of subjects were receiving norepinephrine, 67% vasopressin, 15% phenylephrine, 13% epinephrine, and 2% dopamine.
Danish: På tidspunktet for administration af forsøgslægemidlet fik 97 % af patienterne noradrenalin, 67 % vasopressin, 15 % fenylefrin, 13 % adrenalin og 2 % dopamin.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature and 2-8 °C.
Danish: Kemisk og fysisk brugsstabilitet er påvist i 24 timer ved stuetemperatur og ved 2-8 °C.
English: Diluted solution may be stored at room temperature or under refrigeration.
Danish: Den fortyndede opløsning kan opbevares ved stuetemperatur eller i køleskab.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: When you are first given GIAPREZA, it is expected that your blood pressure will increase.
Danish: Når du får GIAPREZA første gang, forventes det, at dit blodtryk vil stige.
English: The median dose of GIAPREZA was 10 ng/kg/min at 30 minutes.
Danish: Den mediane dosis GIAPREZA var 10 ng/kg/min efter 30 minutter.
English: It is first diluted and then given as a drip (infusion) into a vein, supplying a specified dose each minute.
Danish: Efter fortynding indgives det som infusion (drop) i en blodåre, så du får en specifik dosis pr. minut.
English: - Angiotensin II receptor blockers (medicines used to lower blood pressure, with active substances whose names usually end in -sartan) may lessen the effect of GIAPREZA.
Danish: - Angiotensin II-receptorblokkere (lægemider til sænkning af blodtrykket, hvis aktive stoffer typisk ender på -sartan) kan svække effekten af GIAPREZA.
English: Patients with cardiogenic shock were excluded (see section 4.4).
Danish: Patienter med kardiogent chok blev ekskluderet (se pkt.
English: The addition of GIAPREZA may require a reduction in doses of other vasopressors.
Danish: Tilføjelse af GIAPREZA kan kræve, at dosen af andre vasopressorer reduceres.
English: Of them, 5 cases (3.1%) in the GIAPREZA arm and 3 (1.9%) cases in the placebo arm were considered serious.
Danish: Blandt disse vurderedes 5 tilfælde i GIAPREZA-gruppen (3,1 %) og 3 tilfælde i placebogruppen (1,9 %) at være alvorlige.
English: GIAPREZA will be given to you at the lowest dose that helps you to achieve or maintain your blood pressure.
Danish: GIAPREZA vil blive indgivet i den lavest passende dosis, der kan hjælpe dig med at opnå eller opretholde det ønskede blodtryk.
English: If GIAPREZA is stopped suddenly or stopped too early, you may experience a decrease in your blood pressure or your condition may worsen.
Danish: Hvis GIAPREZA-behandlingen standses pludseligt eller for tidligt, kan du opleve, at dit blodtryk falder, eller at din tilstand forværres.
English: Table 2 lists the adverse reactions recorded in clinical studies in the total safety population treated with GIAPREZA by MedDRA system organ class and frequency.
Danish: Tabel 2 viser en oversigt over de bivirkninger, der er set i kliniske studier i den samlede sikkerhedspopulation ved behandling med GIAPREZA, i henhold til MedDRAs systemorganklasse og hyppighed.
English: Store in a refrigerator (2 - 8 °C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: Yes
Danish: Ja
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe til medicinrester.
English: Withdraw amount (mL)
Danish: Mængde, der skal trækkes op (ml)
English: Peripheral ischaemia
Danish: Perifer iskæmi
English: The most frequent adverse reactions reported more often in the GIAPREZA arm are thromboembolic events (12.9% vs 5.1%) and transient hypertension.
Danish: De hyppigste bivirkninger, der blev rapporteret oftere i GIAPREZA-gruppen, er tromboemboliske hændelser (12,9 % vs. 5,1 %) og forbigående hypertension.
English: GIAPREZA should be gradually decreased since patients may experience hypotension or worsening of the underlying diagnosis of shock on abrupt withdrawal or premature discontinuation.
Danish: GIAPREZA bør seponeres gradvist, da patienterne kan opleve hypotension eller forværring af den underliggende chokdiagnose ved for hurtig eller for tidlig seponering.
English: Your doctor should be told if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby before this medicine is given.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen til råds, før du får dette lægemiddel.
English: Transient hypertension may be promptly mitigated by dose down-titration (see section 4.2).
Danish: Forbigående hypertension kan bedres omgående ved nedtitrering af dosis (se pkt.
English: No specific studies have been conducted to investigate the distribution of GIAPREZA.
Danish: Der er ikke udført specifikke studier til undersøgelse GIAPREZAs fordeling.
English: Patients requiring high doses of steroids, patients with a history of asthma or bronchospasm who were not mechanically ventilated, and patients with Raynaud's syndrome were excluded.
Danish: Patienter, der krævede høje doser steroider, patienter med astma eller bronkospasmer i anamnesen, der ikke var i respirator, samt patienter med Raynauds syndrom blev ekskluderet fra studiet.
English: GIAPREZA may be co-administered with norepinephrine, epinephrine, vasopressin, terlipressin, dopamine, and/or phenylephrine.
Danish: GIAPREZA kan administreres samtidig med noradrenalin, adrenalin, vasopressin, terlipressin, dopamin og/eller fenylefrin.
English: No specific studies have been conducted to investigate the metabolism and excretion of GIAPREZA.
Danish: Der er ikke udført specifikke studier til undersøgelse af metaboliseringen og udskillelsen af GIAPREZA.
English: GIAPREZA contains the active substance angiotensin II, a compound normally produced by the body.
Danish: GIAPREZA indeholder det aktive stof angiotensin II, der er et stof, som kroppen også selv producerer.
English: Thromboembolic events have been reported with the use of angiotensin II in clinical trials.
Danish: Der er rapporteret om tromboemboliske hændelser ved anvendelse af angiotensin II i kliniske forsøg.
English: Your doctor should be told if you are using, have recently used, or might use any other medicines.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: More patients experienced venous and arterial thromboembolic events in the GIAPREZA arm compared to placebo arm in the Phase 3 (ATHOS-3) study (21 [12.9%] vs 8 [5.1%]).
Danish: Flere patienter oplevede venøse og arterielle tromboemboliske hændelser i GIAPREZA-gruppen sammenholdt med placebogruppen i fase 3-studiet (ATHOS-3) (21 [12,9 %] vs. 8 [5,1 %]).
English: The primary endpoint was achieved by 70% of patients randomised to GIAPREZA compared to 23% of placebo subjects; p < 0.0001 (a treatment effect of 47%).
Danish: Det primære endepunkt blev nået af 70 % af patienterne i GIAPREZA-gruppen, sammenholdt med 23 % af patienterne i placebogruppen; p < 0,0001 (en behandlingseffekt på 47 %).
English: Doses of GIAPREZA or placebo were titrated to a target mean arterial pressure (MAP) of ≥ 75 mmHg during the first 3 hours of treatment while doses of other vasopressors were maintained.
Danish: GIAPREZA eller placebo blev titreret til et tilsigtet gennemsnitligt arterietryk (MAP) på ≥ 75 mmHg i de første 3 timer af behandlingen, mens doserne af andre vasopressorer blev opretholdt.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mg/ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 2,5 mg/ml
English: Frequency of adverse reactions MedDRA System Organ Class Very common
Danish: Hyppighed af bivirkninger Systemorganklasse i henhold til MedDRA
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om fortynding af lægemidlet før administration, se pkt.
English: Peripheral ischaemia a Grouped term to include arterial and venous thrombotic events b Defined as an increase in mean arterial pressure > 100 mmHg
Danish: Perifer iskæmi a Samlebetegnelse for arterielle og venøse trombotiske hændelser b Defineret som en stigning i det gennemsnitlige arterietryk > 100 mmHg Beskrivelse af udvalgte bivirkninger
English: In order to minimise the risk of side effects to this medicine, GIAPREZA will be withdrawn as soon as your condition improves.
Danish: For at minimere risikoen for bivirkninger vil behandlingen med GIAPREZA ophøre, så snart din tilstand er forbedret.
English: Pack size of one vial per carton.
Danish: Pakningsstørrelse: 1 hætteglas pr. æske.
English: From Hour 3 to Hour 48, GIAPREZA or placebo were titrated to maintain MAP between 65 and 70 mmHg while reducing doses of other vasopressors.
Danish: Fra time 3 til time 48 blev GIAPREZA eller placebo titreret til at opretholde et gennemsnitligt arterietryk på 6570 mmHg, mens doserne af andre vasopressorer blev reduceret.
English: The recommended starting dosage of GIAPREZA is 20 nanograms (ng)/kg per minute via continuous intravenous infusion.
Danish: Den anbefalede startdosis af GIAPREZA er 20 nanogram (ng)/kg pr. minut ved kontinuerlig intravenøs infusion.
English: Patients also had to have catecholamine refractory hypotension (CRH) defined as requiring a total sum vasopressor dose of > 0.2 mcg/kg/min for 6 to 48 hours, to maintain a mean arterial pressure (MAP) between 55-70 mmHg and receiving at least 25 mL/kg of crystalloid or colloid equivalent over the previous 24-hour period and be adequately volume resuscitated in the opinion of the treating investigator.
Danish: Patienterne skulle også have katekolamin-refraktær hypotension defineret som behov for en samlet vasopressordosis på > 0,2 mikrogram/kg/min i 648 timer for at opretholde et gennemsnitligt arterietryk på 55-70 mmHg og behov for indgift af mindst 25 ml/kg krystalloid- eller kolloidækvivalent i løbet af de forudgående 24 timer, ligesom patienterne skulle have en tilstrækkeligt genetableret væskebalance i henhold til den behandlende læges vurdering.
English: ACE inhibitors may increase to the effect of GIAPREZA.
Danish: ACE-hæmmere kan øge effekten af GIAPREZA.
English: The major imbalance corresponded to venous thromboembolism (10 [6.1%] vs 0 [0%] respectively).
Danish: Den største forstyrrelse var venøs tromboemboli (10 [6,1 %] vs. 0 [0 %]).
English: For intravenous use only after dilution.
Danish: Kun til intravenøs anvendelse efter fortynding.
English: If you have too much GIAPREZA, you may experience high blood pressure.
Danish: Hvis du får meget GIAPREZA, kan du opleve forhøjet blodtryk.
English: GIAPREZA is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies (see section 5.1).
Danish: GIAPREZA er indiceret til behandling af refraktær hypotension hos voksne med septisk eller anden form for distributivt chok, der forbliver hypotensive på trods af relevant volumenrestitution og anvendelse af katekolaminer og andre tilgængelige vasopressorterapier (se pkt.
English: The Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) was a Phase 3 randomised, placebo-controlled, double-blind, international, multi-centre safety and efficacy study in which 321 adults with septic or other distributive shock who remained hypotensive despite fluid and vasopressor therapy were randomised 1:1 to GIAPREZA or placebo.
Danish: ATHOS-3-studiet (Angiotensin II for the Treatment of High-Output Shock (angiotensin II til behandling af højoutput-chok)) er et randomiseret, placebokontrolleret, dobbeltblindet, internationalt fase 3-studie på flere centre til undersøgelse af angiotensin II's sikkerhed og virkning, hvor 321 voksne med septisk eller anden form for distributivt chok, der forblev hypotensive på trods af væske- og vasopressorterapi, blev randomiseret til GIAPREZA eller placebo i forholdet 1:1.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER La Jolla Pharmaceutical II B.V.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN La Jolla Pharmaceutical II B.V.
English: Tell your doctor or nurse immediately if you experience a change of colour (redness or paleness), pain, numbness in any of your limbs, or if any of your limbs are cold to the touch, as these could be signs that a blood clot has blocked blood flow to a part of the body.
Danish: Du skal sige det til lægen eller sygeplejersken med det samme, hvis du oplever en farveændring (rødme eller bleghed), smerter eller følelsesløshed i et ben eller en arm, eller hvis et ben eller en arm føles kold, da det kan være tegn på, at en blodprop har blokeret blodtilførslen til en del af kroppen.
English: Stopping GIAPREZA treatment
Danish: Ophør med GIAPREZA-behandling
English: No special dose adjustment is required in patients over 75 years.
Danish: Det er ikke nødvendigt at justere dosis særskilt hos patienter over 75 år.
English: One patient in each arm discontinued treatment as a result.
Danish: I den forbindelse blev behandlingen seponeret hos én patient i hver af grupperne.
English: GIAPREZA is supplied in a carton as a 1 x 1 ml or 1 x 2 ml single use vial.
Danish: GIAPREZA leveres i en æske med et engangshætteglas a 1 x 1 ml eller 1 x 2 ml.
English: Fluid Restricted?
Danish: Væskerestr iktion?
English: There are no dose adjustments needed for patients more than 75 years of age.
Danish: Det er ikke nødvendigt at justere dosis hos patienter over 75 år.
English: Once an infusion has been established, the dose may be titrated as frequently as every 5 minutes in steps of up to 15 ng/kg per minute, as needed, depending on the patient's condition and target mean arterial pressure.
Danish: Når infusionen er sat i gang, kan dosen titreres så hyppigt som hvert 5. minut i trin af op til 15 ng/kg pr. minut, alt efter behov, afhængig af patientens tilstand og tilsigtet gennemsnitligt arterietryk.
English: No in vitro metabolism studies have been performed with GIAPREZA.
Danish: Der er ikke udført in vitro-metabolismestudier med GIAPREZA.
English: Your doctor or nurse should be told if any of the above applies to you before this medicine is used.
Danish: Hvis noget af ovenstående gælder for dig, skal lægen eller sygeplejersken have det at vide, før dette lægemiddel anvendes.
English: Instructions for dilution
Danish: Instruktioner om fortynding
English: Patients who have recently received angiotensin II receptor blockers (ARBs) may be less sensitive to GIAPREZA's actions with a reduced response.
Danish: Patienter, der for nylig har fået angiotensin II-receptorblokkere, kan være mindre følsomme over for GIAPREZAs effekt og udvise lavere respons.
English: A total of 37 patients (23%) experienced transient hypertension with the angiotensin II 20 ng/kg/min starting dose.
Danish: I alt 37 patienter (23 %) oplevede forbigående hypertension ved en startdosis af angiotensin II på 20 ng/kg/min.
English: Thromboembolic eventsa Transient hypertensionb
Danish: Tromboemboliske hændelsera Forbigående hypertensionb
English: More patients experienced peripheral ischaemia in the GIAPREZA arm compared to the placebo arm (7 [4.3%] vs 4 [2.5%]).
Danish: Flere patienter oplevede perifer iskæmi i GIAPREZA-gruppen sammenholdt med placebogruppen (7 [4,3 %] vs. 4 [2,5 %]).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: For their inclusion in the study, patients had to have clinical features of high-output shock defined as a cardiac index > 2.3 L/min/m2 or the sum of central venous oxygen saturation > 70% with central venous pressure (CVP) > 8 mmHg.
Danish: For at blive inkluderet i studiet skulle patienterne have kliniske karakteristika for højoutput-chok defineret som et hjerteindeks på > 2,3 l/min/m2 eller en samlet central venøs iltmætning på > 70 %
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 2.5 mg/ml, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 2,5 mg/ml, dvs. det er i det væsentlige natriumfrit.
English: Peripheral ischaemia has been reported with the use of angiotensin II (see section 4.8).
Danish: Der er rapporteret om perifer iskæmi ved anvendelse af angiotensin II (se pkt.
English: The recommended starting rate of GIAPREZA is 20 nanograms (ng) per kilogram of your body weight per minute.
Danish: Den anbefalede startdosis af GIAPREZA er 20 nanogram (ng) pr. kilo legemsvægt pr. minut.
English: Other medicines and GIAPREZA
Danish: Brug af anden medicin sammen med GIAPREZA
English: Breast-feeding should be discontinued during treatment with GIAPREZA.
Danish: Amning bør ophøre under behandling med GIAPREZA.
English: This medicine contains less than 1 mmol sodium (23 mg) per 2.5 mg/1 ml, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 2,5 mg/1 ml, dvs. det er i det væsentlige natriumfrit.
English: Angiotensin II raises blood pressure by vasoconstriction; increased aldosterone release via direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein-coupled angiotensin II receptor type 1 on vascular smooth muscle cells which stimulates Ca2+/calmodulin dependent phosphorylation of myosin and causes smooth muscle contraction.
Danish: Øget frigivelse af aldosteron via angiotensin II's direkte effekt på karvæggene medieres ved binding til den G-protein-koblede angiotensin II-receptor type 1 på vaskulære glatte muskelceller, hvilket stimulerer Ca2+/calmodulin-afhængig fosforylering af myosin og forårsager kontraktion af den glatte muskulatur.
English: Tell your doctor immediately if you experience: - Pain, redness or pale colour, swelling or coolness to the touch of the skin or limbs, as these may be symptoms of a blood clot in one of your veins.
Danish: Fortæl det altid til lægen med det samme, hvis du oplever: - Smerter, rødme, bleghed, hævelse, eller hvis huden eller et ben eller en arm føles kold, da det kan være symptomer på en blodprop.
English: 91% of subjects had septic shock; the remaining subjects had other forms of distributive shock such as neurogenic shock.
Danish: De øvrige patienter havde andre former for distributivt chok, f.eks. neurogent chok.
English: What GIAPREZA contains - The active substance is angiotensin II acetate.
Danish: GIAPREZA indeholder: - Aktivt stof: angiotensin II-acetat.
English: Patients who have recently received angiotensin converting enzyme (ACE) inhibitors may be more sensitive to GIAPREZA's action with an increased response.
Danish: Patienter, der for nylig har fået ACE-hæmmere (angiotensinkonvertasehæmmere), kan være mere følsomme over for GIAPREZAs effekt og udvise øget respons.
English: No trials have been conducted to investigate the pharmacokinetics of angiotensin II in patients with hepatic impairment since the liver is 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 leverfunktion, da leveren ikke er et væsentligt organ for angiotensin II's metabolisering eller udskillelse.
English: One vial of 1 ml concentrate for solution for infusion contains 2.5 mg of angiotensin II One vial of 2 ml concentrate for solution for infusion contains 5 mg of angiotensin II - The other ingredients are mannitol and water for injections adjusted with sodium hydroxide and/or hydrochloric acid (see section 2 under ‘Sodium').
Danish: Et hætteglas med 1 ml koncentrat til infusionsvæske, opløsning, indeholder 2,5 mg angiotensin II Et hætteglas med 2 ml koncentrat til infusionsvæske, opløsning, indeholder 5 mg angiotensin II - Øvrige indholdsstoffer: mannitol og vand til injektionsvæsker justeret med natriumhydroxid og/eller saltsyre (se pkt.
English: Sodium content
Danish: Indhold af natrium
English: It is important to administer GIAPREZA at the lowest compatible dose to achieve or maintain adequate arterial blood pressure and tissue perfusion (see section 4.4).
Danish: Det er vigtigt at administrere GIAPREZA i den lavest forenelige dosis for at opnå eller vedligeholde et passende arterielt blodtryk og tilstrækkelig vævsperfusion (se pkt.