FrancophonIA/ELRC3.0 huggingface dataset:
English: Shelf life after first opening of the tube: 8 weeks
Danish: Holdbarhed efter anbrud: 8 uger
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Resocortol butyrate 1mg/g
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Resocortol butyrat 1 mg/g
English: 6.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from such medicinal products
Danish: 6.5 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte lægemidler eller affald fra sådanne
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only
Danish: TEKSTEN ”TIL DYR” Til dyr
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cutaneous use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til anvendelse på huden.
English: STATEMENT OF THE ACTIVE SUBSTANCE Resocortol butyrate: 1mg/g
Danish: ANGIVELSE AF AKTIVT STOF Resocortol butyrat: 1 mg/g
English: The dog should be re-examined by the veterinarian, if the lesion is not cured after 14 days of treatment.
Danish: Såfremt læsionen ikke er afhelet efter 14 dage, bør hunden undersøges af dyrlægen igen.
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: INDICATION(S) Treatment of acute localised moist dermatitis.
Danish: INDIKATION(ER) Behandling af akut lokal fugtig dermatitis.
English: Treatment of acute localised moist dermatitis.
Danish: Behandling af akut lokal fugtig dermatitis.
English: 4.5 Special precaution(s) for use
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen
English: INDICATION Treatment of acute localised moist dermatitis.
Danish: INDIKATIONER Behandling af akut lokal fugtig dermatitis.
English: 4.8 Interaction with other veterinary medicinal products and other forms of interaction Do not apply other topical preparations concomitantly to the same lesions.
Danish: Bør ikke anvendes sammen med andre midler til lokal anvendelse på samme læsioner.
English: PHARMACEUTICAL FORM White to off-white cream
Danish: Hvid til råhvid creme
English: PHARMACEUTICAL PARTICULARS 6.1 Incompatibilities None known.
Danish: 6.1 Uforligeligheder
English: Do not use in dogs used for breeding and in lactating or pregnant bitches.
Danish: Må ikke anvendes til hunde, der bruges til opdræt eller i lakterende eller drægtige tæver.
English: Wearing disposable gloves, apply the cream gently to the lesion.
Danish: Ved anvendelse af engangshandsker gnides cremen forsigtigt ind i læsionen.
English: THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN" Keep out of reach and sight of children
Danish: TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for børn
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS IF ANY
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: 4.2 Indications for use
Danish: 4.2 Terapeutiske indikationer
English: B. PACKAGE INSERT
Danish: B. INDLÆGSSEDDEL
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Danish: A. INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR
English: QUANTITY OF THE ACTIVE SUBSTANCE Resocortol butyrate 1 mg/g
Danish: Resocortol butyrat 1 mg/g
English: Do not use in dogs for breeding nor in lactating or pregnant bitches.
Danish: Må ikke anvendes til avlsdyr eller til diegivende eller drægtige hunhunde.
English: Apply to the affected skin by gently applying it to the lesion.
Danish: Cremen påføres det behandlingskrævende hudområde ved forsigtigt at gnide den ind i læsionen.
English: Veterinary medicinal product subject to prescription.
Danish: DYREARTER, SOM LÆGEMIDLET ER BEREGNET TIL
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Danish: SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE
English: ROUTE(S) OF ADMINISTRATION Cutaneous use.
Danish: INDGIVELSESVEJ(E) Til anvendelse på huden BATCHNUMMER
English: It has not been tested in other types of shock.
Danish: Det er ikke blevet testet ved andre typer chok.
English: 38/58 patients mITT=modified intent-to-treat population
Danish: 38/58 patienter mITT = modificeret intent-to-treat-population
English: Use of this medicine during pregnancy should be avoided if possible.
Danish: Anvendelse af dette lægemiddel under graviditet bør om muligt undgås.
English: 4.7 Effects on ability to drive and use machines Not relevant.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Ikke relevant.
English: A risk to the suckling child cannot be excluded.
Danish: En risiko for det ammede barn kan ikke udelukkes.
English: If this occurs, hospital staff will monitor your vital signs and you will be provided with supportive care.
Danish: Hvis det sker, vil hospitalspersonalet overvåge dine vitale tegn, og du vil få understøttende behandling.
English: The dose depends on your body weight.
Danish: Dosen afhænger af din legemsvægt.
English: These types of symptoms occur in greater than 1 out of every 10 patients.
Danish: Denne type symptomer kan forekomme hos mere end 1 ud af 10 patienter.
English: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath Ireland
Danish: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath Irland
English: pH: 5.0 to 6.0
Danish: pH: 5,0-6,0
English: Overdose may result in severe hypertension.
Danish: Overdosering kan medføre svær hypertension.
English: Median age was 64 years (range: 22-89 years).
Danish: Den mediane alder var 64 år (interval: 22-89 år).
English: Osmolarity: 130 to 170 mOsm/kg
Danish: Osmolaritet: 130-170 mOsm/kg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1384/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1384/001
English: Of these, 7 cases corresponded to deep vein thrombosis.
Danish: Blandt disse var der 7 tilfælde af dyb venetrombose.
English: You will be monitored closely to make sure that your blood pressure is at the right level.
Danish: Du vil blive overvåget tæt for at sikre, at dit blodtryk er på det rigtige niveau.
English: There are no data available on the potential effects on fertility in humans.
Danish: Der foreligger ingen data om den potentielle indvirkning på fertiliteten hos mennesker.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger.
English: Primary efficacy endpoints: MAP response at hour 3 (mITT population and subgroups)
Danish: Primære endepunkter: MAP-respons ved time 3 (mITT-population og delgrupper)
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør opløsningen anvendes med det samme.
English: Baseline APACHE II > 30 17/65 patients
Danish: Baseline-APACHE II > 30 17/65 patienter
English: However, if you have side effects or think you have been given too much GIAPREZA, tell your doctor or nurse straight away.
Danish: Men hvis du får bivirkninger eller mener, at du har fået for meget GIAPREZA, skal du sige det til lægen eller sygeplejersken med det samme.
English: Baseline MAP < 65 mmHg 10/50 patients
Danish: Baseline-MAP < 65 mmHg 10/50 patienter
English: The effect on MAP was sustained for at least the first three hours of treatment.
Danish: Effekten på MAP blev opretholdt i minimum de første 3 timer af behandlingen.
English: Instructions for preparation of the medicinal product before administration 1.
Danish: Vejledning i klargøring af lægemidlet før administration 1.
English: GIAPREZA should not be used in children or adolescents under 18 years of age as it has not been studied in these age groups.
Danish: GIAPREZA bør ikke bruges til børn og unge under 18 år, da det ikke er undersøgt hos denne aldersgruppe.
English: Final concentration (ng/mL)
Danish: Slutkoncentra tion (ng/ml)
English: You will only be given this medicine if the possible benefit is greater than the possible risks.
Danish: Du vil kun få dette lægemiddel, hvis de mulige fordele opvejer de mulige risici.
English: Patients were not necessarily on maximum doses of other vasopressors at the time of randomisation.
Danish: Patienterne var ikke nødvendigvis på maksimal dosis af andre vasopressorer på tidspunktet for randomisering.
English: Mechanism of action and pharmacodynamic effects
Danish: Virkningsmekanisme og farmakodynamisk virkning
English: Animal studies are insufficient with respect to reproductive toxicity.
Danish: Data fra dyreforsøg er utilstrækkelige, hvad angår reproduktionstoksicitet.
English: The effect of GIAPREZA on morbidity and mortality has not been determined in appropriate studies.
Danish: GIAPREZAs effekt på morbiditet og dødelighed er ikke fastlagt i relevante studier.
English: 114/163 patients
Danish: 114/163 patienter
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single-dose.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Enkeltdosis.
English: The effect on blood pressure is sustained for at least the first three hours of continuous intravenous infusion.
Danish: Effekten på blodtrykket opretholdes som minimum i de første tre timer med kontinuerlig intravenøs infusion.
English: Storage conditions
Danish: Opbevaringsbetingelser
English: 28/52 patients
Danish: 28/52 patienter
English: Of the 114 responders at Hour 3, only 2 (1.8%) received more than 80 ng/kg/min.
Danish: Af de 114 respondere efter time 3 fik kun 2 (1,8 %) mere end 80 ng/kg/min.
English: The median duration of treatment in clinical trials was 48 hours (range: 3.5 to 168 hours).
Danish: Den mediane behandlingsvarighed i kliniske forsøg var 48 timer (interval: 3,5-168 timer).
English: In the ATHOS-3 trial, the median time to increase blood pressure was approximately 5 minutes.
Danish: I ATHOS-3-forsøget var den mediane tid til opnåelse af øget blodtryk ca. 5 minutter.
English: The diluted solution should be used immediately.
Danish: Den fortyndede opløsning bør anvendes med det samme.
English: 1017 CB, Amsterdam The Netherlands
Danish: 1017 CB, Amsterdam Nederlandene
English: Very common side effects (may affect more than 1 in 10 people) are: - Too high blood pressure
Danish: Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 patienter): - Forhøjet blodtryk
English: OTHER La Jolla Pharmaceutical
Danish: ANDET La Jolla Pharmaceutical
English: Other side effects are:
Danish: Andre bivirkninger:
English: Diluted solution should be clear and colourless.
Danish: Den fortyndede opløsning skal være klar og farveløs.
English: GIAPREZA will be given to you in a hospital by a doctor or a nurse.
Danish: Du vil få indgivet GIAPREZA på et hospital af en læge eller en sygeplejerske.
English: Use during pregnancy should be avoided if possible and the potential benefit to the patient weighed against any possible risk to the foetus.
Danish: Anvendelse under graviditet bør om muligt undgås, idet den mulige fordel for patienten bør afvejes mod den mulige risiko for fostret.
English: The adverse reactions described in this section were identified in the pivotal clinical study (N = 163 treated with GIAPREZA).
Danish: De bivirkninger, der beskrives i dette afsnit, er set i det centrale kliniske studie (N = 163 behandlet med GIAPREZA).
English: Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/10,000 to < 1/100), rare (≥ 1/10,000
Danish: Hyppigheden defineres som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden Tabel 2:
English: As a part of your treatment, you may be given medicine to prevent the formation of blood clots.
Danish: Som led i din behandling kan du få medicin til forebyggelse af blodpropper.
English: GIAPREZA was tested in a small amount of patients more than 75 years of age.
Danish: GIAPREZA er testet hos et lille antal patienter over 75 år.
English: Your doctor may already be giving you other medicines used to increase your blood pressure.
Danish: Det kan være, lægen allerede giver dig andre lægemidler til øgning af dit blodtryk.
English: Transient hypertension
Danish: Forbigående hypertension
English: It is unknown whether angiotensin II or its metabolites are excreted in human milk.
Danish: Det er ukendt, om angiotensin II eller dets metabolitter udskilles i human mælk.
English: Hypertensive effects are expected to be brief because the half-life of angiotensin II is less than one minute.
Danish: Den hypertensive effekt forventes at være kortvarig, da halveringstiden for angiotensin II er under ét minut.
English: 83% of subjects had received two or more vasopressors and 47% three or more vasopressors prior to study drug administration.
Danish: 83 % af patienterne havde fået to eller flere vasopressorer og 47 % tre eller flere vasopressorer inden administration af forsøgslægemidlet.
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac stimulants, ATC code: C01CX09
Danish: Farmakoterapeutisk klassifikation: Hjerteterapi, andre hjertestimulerende midler, ATC-kode: C01CX09
English: 1017CB Amsterdam, Netherlands
Danish: 1017 CB Amsterdam, Nederlandene
English: 37/158 patients
Danish: 37/158 patienter
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 - 8 °C or 25 °C.
Danish: Hvis den ikke anvendes med det samme, er det brugerens ansvar at sikre egnede opbevaringsforhold før ibrugtagning, idet opbevaringstiden normalt højst vil være 24 timer ved 2-8 °C eller ved 25 °C.
English: There are limited efficacy and safety data of GIAPREZA in patients > 75 years.
Danish: Der er begrænsede data om virkningen og sikkerheden ved GIAPREZA hos patienter > 75 år.
English: The maximum dose after the first 3 hours will be 40 ng per kilogram each minute.
Danish: Den maksimale dosis efter de første 3 timer vil være 40 ng pr. kilo pr. minut.
English: The solution is a clear, colourless solution free of any visible particles.
Danish: Opløsningen er klar og farveløs uden synlige partikler.
English: Administer as a diluted solution.
Danish: Administreres som en fortyndet opløsning.
English: No treatment related adverse effects were observed.
Danish: Der er ikke set behandlingsrelaterede bivirkninger.
English: For critically ill patients, the usual target mean arterial pressure is 65 - 75 mmHg.
Danish: For kritisk syge patienter vil det tilsigtede gennemsnitlige arterietryk typisk være 65-75 mmHg.
English: In the GIAPREZA-treated group, the median time to reach the target MAP endpoint was 5 minutes.
Danish: I GIAPREZA-gruppen var den mediane tid til opnåelse af det ønskede MAP-endepunkt 5 minutter.
English: Inspect each vial for particulate matter prior to dilution.
Danish: Kontrollér det enkelte hætteglas for partikler inden fortynding.
English: If you notice any of these symptoms, seek medical advice immediately.
Danish: Hvis du bemærker et af disse symptomer, skal du straks søge læge.
English: The safety and efficacy of GIAPREZA in children less than 18 years old has not yet been established.
Danish: GIAPREZAs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Plasma levels of angiotensin II were evaluated at baseline and hour 3 of infusion in the phase 3 pivotal study.
Danish: Plasmaniveauet af angiotensin II blev vurderet ved baseline og ved time 3 efter infusion i det centrale fase 3-studie.
English: It is metabolised by end terminal cleavage (at both the amino and carboxy termini) in a variety of tissues including erythrocytes, plasma and many of the major organs (ie, intestine, kidney, liver and lung).
Danish: Det metaboliseres ved endeterminal-spaltning (ved både amino- og carboxylterminus) i en række forskellige væv, herunder erytrocytter, plasma og mange af de større organer (dvs. tarme, nyrer, lever og lunger).
English: It makes the blood vessels tighten and become narrower, thus increasing blood pressure.
Danish: Det får blodkarrene til at trække sig sammen og blive snævrere, hvorved blodtrykket øges.
English: These clots may travel through blood vessels to the lungs causing chest pain and difficulty breathing.
Danish: En blodprop kan føres gennem blodkarrene til lungerne og forårsage brystsmerter og vejrtrækningsbesvær.
English: • Periodic safety update reports
Danish: • Periodiske, opdaterede sikkerhedsberetninger (PSUR'er)
English: The treatment effect was consistent in high risk subsets of patients with low baseline MAP or high APACHE II score, which were stratification variables (Table 3).
Danish: Behandlingseffekten var konsistent hos delgrupper af højrisikopatienter med lavt baseline-MAP eller høj APACHE II-score (stratificeringsvariable) (tabel 3).
English: Doses as low as 1.25 ng/kg per minute may be used.
Danish: Doser på helt ned til 1,25 ng/kg pr. minut kan anvendes.
English: Of the 321 patients treated in the Phase 3 study, 195 patients were male (60.7%), 257 (80%) patients were White, 33 (10%) were Black, and 31 (10%) were Other.
Danish: Af de 321 patienter, der blev behandlet i fase 3-studiet, var 195 mænd (60,7 %), 257 (80 %) var hvide, 33 (10 %) var sorte, og 31 (10 %) var andet.
English: GIAPREZA is titrated to effect for each individual patient.
Danish: GIAPREZA titreres efter den ønskede effekt hos den enkelte patient.
English: Placebo response rate
Danish: Responsrate for placebo
English: Dilute before use.
Danish: Fortyndes før brug.
English: While not all of these symptoms lead to life-threatening complications, your doctor should be told about them immediately.
Danish: Det er ikke alle disse symptomer, der kan give livstruende komplikationer, men du skal alligevel sige det til lægen med det samme, hvis oplever dem.
English: GIAPREZA should be prescribed by a physician experienced in the treatment of shock and is intended for use in an acute and hospital setting.
Danish: GIAPREZA bør ordineres af en læge med erfaring i behandling af chok og er beregnet til anvendelse i akutte tilfælde på hospitaler.
English: Mortality through day 28 was 46% on GIAPREZA and 54% on placebo (hazard ratio 0.78; 95% confidence interval 0.57-1.07).
Danish: Dødeligheden ved dag 28 var 46 % ved GIAPREZA og 54 % ved placebo (hazard ratio 0,78; 95 %konfidensinterval 0,57-1,07).
English: What you need to know before you are given GIAPREZA 3.
Danish: Det skal du vide, før du får GIAPREZA 3.
English: Your doctor or nurse should be told before GIAPREZA is used if you or someone else in your family have a history of blood clots, as this medicine has been associated with the formation of blood clots.
Danish: Lægen eller sygeplejersken skal have det at vide inden anvendelse af GIAPREZA, hvis du eller nogen i din familie tidligere har haft blodpropper, da dette lægemiddel har været forbundet med dannelse af blodpropper.
English: Non-pharmacologic VTE prophylaxis may be considered where pharmacologic prophylaxis is contraindicated.
Danish: Ikkefarmakologisk VTE-profylakse kan overvejes, hvis farmakologisk profylakse er kontraindiceret.
English: Concomitant administration of GIAPREZA and other vasopressors may have an additive effect on mean arterial pressure (MAP).
Danish: Samtidig administration af GIAPREZA og andre vasopressorer kan have en additiv virkning på det gennemsnitlige arterietryk (MAP).
English: Common side effects (may affect up to 1 in 10 people) are: - Rapid heartbeat - Poor circulation to your hands, feet, or other bodily areas which can be severe and cause tissue damage.
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter): - Hurtig hjerterytme - Nedsat blodforsyning til hænder, fødder eller andre kropsområder - kan være alvorligt og medføre vævsskade.
English: GIAPREZA is used in an emergency setting to increase blood pressure to normal levels in adult patients with seriously low blood pressure who do not respond to fluids or other medicines that raise blood pressure.
Danish: GIAPREZA anvendes i nødsituationer til at øge blodtrykket til normalt niveau hos voksne patienter med svært nedsat blodtryk, der ikke reagerer på behandling med væske eller andre lægemidler til øgning af blodtrykket.
English: Adding GIAPREZA to these medicines may require that the doses of the other medicines be lowered.
Danish: Hvis GIAPREZA tilføjes til disse lægemidler, kan det betyde, at dosen af de andre lægemidler skal reduceres.
English: The effect of GIAPREZA when added to maximum doses of other vasopressors is unknown.
Danish: GIAPREZAs virkning ved tilføjelse til maksimale doser af andre vasopressorer kendes ikke.
English: The use of GIAPREZA is not recommended in other types of shock (e.g.: cardiogenic shock, etc) as patients with non-distributive shocks were excluded from clinical trials (see section 5.1).
Danish: Anvendelse af GIAPREZA anbefales ikke ved andre typer chok (f.eks. kardiogent chok mv.), da patienter med non-distributivt chok var ekskluderet fra de kliniske forsøg (se pkt.
English: No
Danish: Nej
English: For single dose only.
Danish: Kun til enkeltdosisbrug.
English: Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Danish: Vand til injektionsvæsker Natriumhydroxid (til pH-justering) Saltsyre (til pH-justering)
English: Down-titration of therapy, careful observation, and initiation of appropriate supportive measures are the indicated treatment of overdose of angiotensin II.
Danish: Nedtitrering af lægemidlet, nøje observation og iværksættelse af understøttende behandling er indiceret ved overdosering af angiotensin II.
English: After the initial dose, your doctor will adjust the rate as often as every 5 minutes until you achieve your target blood pressure.
Danish: Efter startdosen vil lægen justere din dosis så ofte som hvert 5. minut, indtil du opnår det ønskede blodtryk.
English: Maintenance doses should not exceed 40 ng/kg per minute.
Danish: Vedligeholdelsesdoser bør ikke overskride 40 ng/kg pr. minut.
English: Your doctor will gradually decrease the amount of GIAPREZA you are given over time once your blood pressure has increased to appropriate levels.
Danish: Lægen vil gradvist reducere den mængde GIAPREZA, du får over tid, når dit blodtryk er steget til det ønskede niveau.
English: What you need to know before you are given GIAPREZA You must not be given GIAPREZA: - if you are allergic to angiotensin II or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få GIAPREZA: - hvis du er allergisk over for angiotensin II eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Due to the short half-life of GIAPREZA (less than one minute), an abrupt withdrawal of angiotensin may lead to rebound hypotension (see section 4.4).
Danish: På grund af GIAPREZAs korte halveringstid (under et minut) kan pludselig seponering af angiotensin føre til rebound-hypotension (se pkt.
English: In a 48-hour continuous intravenous administration of angiotensin II in neonatal lambs, the nominal dose rates of 4, 12 and 40 ng/kg/min were well tolerated.
Danish: Ved kontinuerlig intravenøs administration af angiotensin II i 48 timer hos nyfødte lam blev de nominelle doser på 4, 12 og 40 ng/kg/min godt tolereret.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with GIAPREZA in one or more subsets of the paediatric population for the treatment of hypotension in children who remain hypotensive despite fluid and vasopressor therapy.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med GIAPREZA i en eller flere undergrupper af den pædiatriske population ved behandling af hypotension hos børn, der forbliver hypotensive på trods af væske- og vasopressorterapi.
English: There is a limited amount of data from the use of angiotensin II in pregnant women.
Danish: Der er kun begrænsede oplysninger om anvendelse af angiotensin II hos gravide kvinder.