FrancophonIA/ELRC3.0 huggingface dataset:
English: The protein binding for PAGN was 7% to 12% and no concentration effects were noted.
Danish: Proteinbindingen af PAGN var 7 % til 12 %, og der blev ikke bemærket nogen koncentrationsafhængig effekt.
English: Special populations Elderly (65 years or older)
Danish: Ældre (65 år og derover)
English: There are no data for human fertility.
Danish: Der foreligger ingen data vedrørende fertilitet hos mennesker.
English: System Organ Class Preferred Term
Danish: Systemorganklasse Foretrukken term
English: PAGN is subsequently eliminated in the urine.
Danish: PAGN udskilles derefter i urinen.
English: • You will need regular blood tests so your doctor can determine the correct dose for you.
Danish: • Du vil regelmæssigt få taget blodprøver, så lægen kan fastlægge den korrekte dosis for dig.
English: Dose adjustment and monitoring in adults and children:
Danish: Dosisjustering og overvågning hos voksne og børn:
English: The length of study participation ranged from 0.2 to 5.9 years.
Danish: Studiedeltagelsens varighed var mellem 0,2 til 5,9 år.
English: Use within 14 days of opening.
Danish: Skal bruges inden for 14 dage efter åbning.
English: Total (N=10)
Danish: I alt (N = 10)
English: Your doctor will tell you how to take RAVICTI oral liquid.
Danish: Din læge vil fortælle dig, hvordan du skal tage RAVICTI oral væske.
English: • Your doctor may give you a lower dose if you have kidney or liver problems.
Danish: • Din læge vil muligvis give dig en lavere dosis, hvis du har nyre- eller leverproblemer.
English: Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: Your doctor will tell you how much RAVICTI you should take each day.
Danish: Din læge vil fortælle dig, hvor meget RAVICTI du skal tage hver dag.
English: - You must follow this diet carefully.
Danish: - Du skal følge denne kostplan nøje.
English: • reduced number of red blood cells
Danish: • nedsat antal røde blodlegemer
English: Oral liquid.
Danish: Oral væske.
English: Unimedic AB Storjordenvägen 2 SE-864 31 Matfors Sweden
Danish: Unimedic AB Storjordenvägen 2 SE-864 31 Matfors Sverige
English: Take RAVICTI with or straight after a meal.
Danish: Tag RAVICTI med eller lige efter et måltid.
English: Hereford, Herefordshire, HR3 5PG United Kingdom
Danish: Hereford, Herefordshire, HR3 5PG Storbritannien
English: Non-interventional post-authorisation safety study (PASS):
Danish: Ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS):
English: Paediatric population Posology is the same for adult and paediatric patients.
Danish: Pædiatrisk population Doseringen er den samme for voksne og pædiatriske patienter.
English: Total (N=16)
Danish: (N = 16)
English: • Hypersensitivity to the active substance.
Danish: • Overfølsomhed over for det aktive stof.
English: In other cases the amount of ammonia in the blood goes up quickly.
Danish: I andre tilfælde kan mængden af ammoniak i blodet stige hurtigt.
English: Monitoring and laboratory tests
Danish: Monitorering og laboratorieundersøgelser
English: Development studies
Danish: Udviklingsstudier
English: Frequency is defined as 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 (cannot be estimated from the available data).
Danish: Hyppigheden defineres som 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), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Reversal of the pre-existing neurological impairment is unlikely following treatment and neurological deterioration may continue in some patients.
Danish: Revertering af eksisterende neurologiske skader er ikke sandsynlig som følge af behandling, og neurologisk forværring kan ses hos nogle patienter.
English: Spot U-PAGN concentrations below the following levels may indicate improper medicinal product administration and/or lack of compliance:
Danish: Spot-U-PAGN-koncentrationer under følgende niveauer kan indikere forkert administration af lægemidlet og/eller manglende komplians:
English: Talk to your doctor about the best method of contraception for you.
Danish: Tal med din læge om, hvilken præventionsmetode er bedst for dig.
English: It can be taken in the following ways:
Danish: Den kan tages på flere måder:
English: • Your doctor might tell you to take RAVICTI more than 3 times each day.
Danish: • Din læge vil muligvis instruere dig i at tage RAVICTI mere end 3 gange om dagen.
English: Study 3 was 14 days in duration and Study 4 was 10 days in duration.
Danish: Varigheden af studie 3 var 14 dage, og varigheden af studie 4 var 10 dage.
English: If you notice any of the following signs, talk to a doctor or go to a hospital straight away as these may be signs of overdose or high ammonia:
Danish: Hvis du bemærker nogle af de følgende tegn, skal du tale med en læge eller straks tage på hospitalet, da de kan være tegn på en overdosis eller et højt ammoniakniveau:
English: 1 x 25 ml bottle.
Danish: 1 x 25 ml flaske.
English: Dietary protein is approximately 16% nitrogen by weight.
Danish: Kostprotein indeholder ca. 16 % kvælstof efter vægt.
English: • Urea cycle disorders are rare.
Danish: • Urinstofcyklus-defekter er sjældne.
English: Potential for other medicinal products to affect ammonia Corticosteroids
Danish: Andre lægemidlers potentiale til at påvirke ammoniak Kortikosteroider
English: PAA and PBA represented minor urinary metabolites, each accounting for <1% of the administered dose of PBA.
Danish: PAA og PBA repræsenterede mindre væsentlige urinmetabolitter, som hver udgør <1 % af den administrerede dosis PBA.
English: RAVICTI is a pro-drug of PBA.
Danish: RAVICTI er et prodrug til PBA.
English: Embryo toxicity (increased resorptions) and reduced litter size was also observed.
Danish: Embryo-toksicitet (øget resorption) og mindre kuld blev også observeret.
English: • if you have acute hyperammonaemia, which requires more rapid intervention.
Danish: • hvis du har akut hyperammoniæmi, da dette kræver hurtigere indgriben.
English: Ask your doctor or pharmacist which type of syringes you need to obtain based on the prescribed dose volume.
Danish: Spørg din læge eller apotekspersonalet hvilken type af sprøjter du skal købe baseret på det ordinerede dosisvolumen.
English: Clinical studies of RAVICTI did not include sufficient numbers of subjects ≥ 65 years of age to determine whether they respond differently than younger subjects.
Danish: Kliniske studier med RAVICTI inkluderede ikke et tilstrækkeligt antal forsøgspersoner ≥ 65 år til at konkludere, hvorvidt de reagerer anderledes end yngre forsøgspersoner.
English: The liver then removes ammonia from the body through a cycle called the ‘urea cycle'.
Danish: Leveren fjerner derefter denne ammoniak fra kroppen gennem en cyklus, som kaldes "urinstofcyklussen".
English: Clinical studies in adult patients with UCDs
Danish: Kliniske studier hos voksne patienter med UCD'er
English: If ammonia is not removed from the body, it can harm the brain and lead to low levels of consciousness or coma.
Danish: Hvis ikke ammoniak fjernes fra kroppen, kan det være skadeligt for hjernen og medføre et lavere bevidsthedsniveau eller koma.
English: This reduces the amount of ammonia in your body.
Danish: Det reducerer mængden af ammoniak i kroppen.
English: RAVICTI should be taken with meals and administered directly into the mouth via an oral syringe.
Danish: RAVICTI skal tages i forbindelse med måltider og administreres direkte i munden med en oral sprøjte.
English: Each dose should be rounded up to the nearest 0.1 ml for patients less than 2 years of age and 0.5 ml for patients 2 years of age and older.
Danish: Hver dosis skal rundes op til nærmeste 0,1 ml for patienter under 2 år og 0,5 ml for patienter i alderen 2 år og ældre.
English: If you become pregnant while taking RAVICTI, talk to your doctor.
Danish: Hvis du bliver gravid, mens du tager RAVICTI, skal du tale med din læge.
English: Tell your doctor or go to the hospital straight away if you notice any of these signs.
Danish: Kontakt lægen eller tag straks på hospitalet, hvis du bemærker nogle af disse tegn.
English: The median exposure was 10 months (range 2 to 20 months).
Danish: Den gennemsnitlige eksponering var 10 måneder (interval 2-20 måneder).
English: - You will need to have treatment and to follow a diet throughout your life, unless you have a successful liver transplantation.
Danish: - Du vil være nødt til at få behandling og følge en kostplan hele dit liv, medmindre du får en vellykket levertransplantation.
English: At the beginning of the treatment, abdominal pain, nausea, diarrhoea, and/or headache may occur; these reactions usually disappear within a few days even if treatment is continued.
Danish: Ved start af behandling kan der forekomme abdominalsmerter, kvalme, diarré og/eller hovedpine; disse bivirkninger forsvinder som regel inden for et par dage, selvom behandlingen fortsættes.
English: • midazolam and barbiturates - used for sedation, trouble sleeping or epilepsy
Danish: • midazolam og barbiturater - anvendes til bedøvelse, søvnbesvær eller epilepsi
English: − Note: If possible, use the oral syringe ml size that is nearest to (but not smaller than) the recommended dose (for example, if the dose is 0.8 ml, use a 1 ml oral syringe).
Danish: - Bemærk: Brug en oral sprøjte af en størrelse, der er så tæt som muligt på (men ikke mindre end) den anbefalede dosis (hvis dosis f.eks. er 0,8 ml, skal du bruge en 1 ml oral sprøjte).
English: • existing neurological conditions may get worse
Danish: • forværring af eksisterende neurologisk tilstand
English: • problems hearing
Danish: • problemer med hørelsen
English: Remaining unused syringes should be kept for use with another bottle.
Danish: De resterende ubrugte sprøjter bør gemmes, så de kan bruges med en anden flaske.
English: A potential effect on CYP2D6 isoenzyme cannot be excluded and caution is advised for patients who receive medicinal products that are CYP2D6 substrates.
Danish: En potentiel effekt på CYP2D6 kan ikke udelukkes, og det tilrådes at udvise forsigtighed hos patienter, som får lægemidler, der er CYP2D6-substrater.
English: • Normally, the body turns the extra nitrogen in the protein into a waste compound called ‘ammonia'.
Danish: • Normalt omdanner kroppen overskydende kvælstof i proteiner til et affaldsstof kaldet "ammoniak."
English: • If you are a woman who could become pregnant, you must use an effective method of contraception, during treatment with RAVICTI.
Danish: • Hvis du er kvinde og kan blive gravid, skal du bruge en effektiv præventionsmetode under behandling med RAVICTI.
English: Any adverse reaction reported in one patient met the uncommon criteria.
Danish: Enhver bivirkning, der blev rapporteret hos en patient, opfyldte kriterierne for ”ikke almindelig”.
English: For additional information regarding method of administration and compatibility/in-use stability studies please refer to section 6.6.
Danish: For yderligere information angående administrationsmetode og studier af forligelighed/stabilitet under brug, se pkt.
English: • tests show abnormal ECG (‘electrocardiogram')
Danish: • tests viser unormalt EKG ("elektrokardiogram")
English: Juvenile animal study
Danish: Studier med unge dyr
English: The total daily dose should be divided into equal amounts and given with each meal or feeding (e.g. three times to six times per day).
Danish: Den samlede daglige dosis skal opdeles i lige store doser og gives med hvert måltid eller mellemmåltid/amning (f.eks. 3-6 gange om dagen).
English: In case of overdose, the medicinal product should be discontinued and the patient monitored for any signs or symptoms of adverse reactions.
Danish: I tilfælde af overdosering skal behandling med lægemidlet stoppes og patienten overvåges for tegn og symptomer på bivirkninger.
English: Absence of these enzymes or transporters results in the accumulation of toxic levels of ammonia in the blood and brain of affected patients.
Danish: Mangel på disse enzymer eller transportører resulterer i ophobning af ammoniak i toksiske niveauer i blodet og hjernen hos berørte patienter.
English: • Your daily dose will depend on your size and weight, the amount of protein in your diet, and your overall urea cycle disorder condition.
Danish: • Din daglige dosis vil afhænge af din størrelse og vægt, mængden af protein i din kost, og i hvilken grad defekten i din urinstofcyklus påvirker dig.
English: Fertility (number of pregnant rats) was decreased by up to 25%, at a dose of 2.6 times the dose in adult patients.
Danish: Fertilitet (antal drægtige rotter) var reduceret med op til 25 % ved en dosis på 2,6 gange den dosis, der gives til voksne patienter.
English: Do not re-use the oral syringe for measuring the dose of RAVICTI on another day.
Danish: Genbrug ikke den orale sprøjte til afmåling af doser af RAVICITI på en anden dag.
English: Preferably such patients should be started and maintained at the lowest dose necessary to control the blood ammonia levels.
Danish: Så vidt muligt skal sådanne patienter startes og holdes på den laveste dosis, som er nødvendig for at kontrollere ammoniakniveauet i blodet.
English: In healthy adult volunteers, a gender effect was found for all metabolites, with women generally having higher plasma concentrations of all metabolites than men at a given dose level.
Danish: Hos raske, frivillige voksne blev der fundet en kønsrelateret effekt for alle metabolitter, idet kvinder generelt havde højere plasmakoncentrationer af alle metabolitter end mænd ved et givet dosisniveau.
English: Due to the rarity of the UCD population, and the small size of the medicinal product safety population database (N=114), the adverse reaction frequency for rare and very rare is not known.
Danish: Da UCD-patienter er sjældne og populationen i lægemidlets sikkerhedsdatabase lille (N=114), kendes bivirkningshyppigheden sjælden og meget sjælden ikke.
English: • This means that ammonia builds up in the body.
Danish: • Det betyder, at ammoniak ophobes i kroppen.
English: Standard pack size: 1 bottle and 1 reclosable bottle cap adapter per carton.
Danish: Standard pakningsstørrelse: 1 flaske og 1 lukbar adapter per karton.
English: Each bottle should be discarded after 14 days.
Danish: De enkelte flasker skal kasseres efter 14 dage.
English: • poor feeding
Danish: • dårlig ernæring
English: Assay sensitivity was confirmed by significant QTc prolongation of the positive control, moxifloxacin.
Danish: Analysefølsomheden blev bekræftet ved signifikant QTc-forlængelse af den positive kontrol moxifloxacin.
English: Compatibility studies have been conducted (see section 4.5).
Danish: Der er udført forligelighedsstudier (se pkt.
English: The bottle should be discarded even if it is not empty.
Danish: Flasken skal kasseres, selvom den ikke er tom.
English: Any unused product or waste material should be disposed of in accordance with national requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til nationale retningslinjer.
English: Open the bottle of RAVICTI by pushing down on the cap and twisting to the left.
Danish: Åbn flasken med RAVICTI ved at trykke ned på låget og dreje til venstre.
English: Adjustment based on plasma ammonia
Danish: Dosisjustering baseret på ammoniak i plasma
English: • Treatment of acute hyperammonaemia.
Danish: • Behandling af akut hyperammoniæmi.
English: Young children should be given the medicine during or straight after a feeding.
Danish: Små børn skal have lægemidlet, mens de får mad eller lige efter.
English: Do not stop taking glycerol phenylbutyrate without talking to your doctor.
Danish: Du må ikke holde op med at tage glycerolphenylbutyrat uden at tale med din læge.
English: The study enrolled a total of 45 paediatric patients between the ages of 1 and 17 years with UCD who had completed Study 2 and the safety extensions of Studies 3 and 4.
Danish: Studiet inkluderede i alt 45 pædiatriske patienter i alderen fra 1 til 17 år med UCD, som havde fuldført studie 2 og sikkerhedsforlængelserne af studierne 3 og 4.
English: RAVICTI and meals
Danish: RAVICTI og måltider
English: RAVICTI may have major influence on the ability to drive and use machines.
Danish: RAVICTI kan i væsentlig grad påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: RAVICTI helps the body to eliminate waste nitrogen.
Danish: RAVICTI hjælper kroppen med at udskille restkvælstof.
English: For children: if the next dose is in less than 30 minutes, then skip it and give the next dose as normal.
Danish: For børn gælder, at hvis den næste dosis er om mindre end 30 minutter, skal den springes over og den næste dosis gives som normalt.
English: Ammonia levels should be closely monitored in patients with pancreatic insufficiency or intestinal malabsorption.
Danish: Ammoniakniveauet skal monitoreres nøje hos patienter med pancreasinsufficiens eller intestinal malabsorption.
English: Therefore, it is recommended that nasogastric, nasojejunal or gastrostomy tubes only be used to administer doses > 1 ml.
Danish: Det anbefales derfor, at nasogastriske, nasojejunale eller gastrostomisonder kun anvendes til administration af doser > 1 ml.
English: RAVICTI should be prescribed by a physician experienced in the management of UCDs.
Danish: RAVICTI skal ordineres af en læge med erfaring i behandling af UCD'er.
English: In 4 of the 5 subjects age < 1 month, possible risk factors included infectious precipitants, hyperammonaemic crisis at baseline, and missing dose.
Danish: Hos 4 ud af de 5 forsøgsdeltagere < 1 måned inkluderede mulige risikofaktorer infektiøse præcipitater, hyperammoniæmisk krise ved baseline og manglende dosis.
English: This is because it may harm your unborn baby.
Danish: Det skyldes, at RAVICTI kan være skadeligt for dit ufødte barn.
English: • You should not take RAVICTI if you are breast-feeding.
Danish: • Du må ikke tage RAVICTI, hvis du ammer.
English: This patient developed hyperammonemic crisis on day 6, and subsequently died of sepsis from peritonitis unrelated to drug.
Danish: Denne patient udviklede hyperammoniæmisk krise på dag 6, og døde efterfølgende af sepsis pga. peritonitis uden relation til lægemidlet.
English: • valproate - a medicine for epilepsy
Danish: • valproat - et lægemiddel til behandling af epilepsi
English: • If you are pregnant, tell your doctor before you start taking RAVICTI.
Danish: • Hvis du er gravid, skal du fortælle lægen det, inden du begynder at tage RAVICTI.
English: In some cases such as infection or post-surgery, the amount of ammonia may go up despite treatment with this medicine and may damage the brain (hyperammonaemic encephalopathy).
Danish: I visse tilfælde, såsom ved infektion eller efter en operation, kan mængden af ammoniak stige på trods af behandling med denne medicin og være skadelig for hjernen (hyperammoniæmisk encefalopati).
English: • In urea cycle disorders, the body cannot remove the nitrogen from the protein that we eat.
Danish: • Ved urinstofcyklus-defekter kan kroppen ikke fjerne kvælstof fra de proteiner, vi spiser.
English: UCDs are inherited deficiencies of enzymes or transporters necessary for the synthesis of urea from ammonia (NH3, NH4+).
Danish: UCD'er er nedarvede defekter i enzymer eller transportører, der er nødvendige for syntesen af urinstof fra ammoniak (NH3, NH4+).
English: Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels.
Danish: Brug af kortikosteroider kan medføre nedbrydning af kroppens proteiner og øge ammoniakniveauet i plasma.
English: Tell your doctor or pharmacist if you notice any of the following side effects:
Danish: Fortæl lægen eller apotekspersonalet, hvis du oplever nogen af følgende bivirkninger:
English: RAVICTI therapy may be required life long unless orthotopic liver transplantation is elected.
Danish: RAVICTI-terapi kan være nødvendig hele livet igennem, medmindre der udføres ortotopisk levertransplantation.
English: • increased temperature, hot flushes
Danish: • forhøjet temperatur, hedeture
English: Also, tell your doctor if you are taking the following medicines as they may increase the amount of ammonia in your body or change how glycerol phenylbutyrate works:
Danish: Fortæl desuden lægen, hvis du tager nogle af følgende lægemidler, da de kan øge mængden af ammoniak i kroppen eller ændre, hvordan glycerolphenylbutyrat virker:
English: Patients were required to have a diagnosis of UCD involving deficiencies of CPS, OTC, or ASS, confirmed via enzymatic, biochemical, or genetic testing.
Danish: Patienterne skulle have en UCD-diagnose, som involverede defekter i CPS, OTC eller ASS bekræftet ved enzymatisk, biokemisk eller genetisk testning.
English: • bleeding between menstrual periods, acne, skin smells abnormal
Danish: • blødning mellem menstruationer, acne, unormal lugt fra huden
English: Uncommon Gastrointestinal viral infection
Danish: Ikke almindelig Gastrointestinal virusinfektion
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 25 ml BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE 25 ml FLASKEETIKET
English: • Flush once with 10 ml of water or medical formula and allow the flush to drain after administration.
Danish: • Skyl en gang med 10 ml vand eller et ernæringspræparat, og lad sonden tømmes efter administration.
English: Talk to your doctor or pharmacist before taking RAVICTI:
Danish: Kontakt lægen eller apotekspersonalet, før du tager RAVICTI:
English: It is important to ensure that the oral syringe is kept clean and dry between the dosing intervals.
Danish: Det er vigtigt at sørge for, at den orale sprøjte holdes ren og tør mellem doserne.
English: If the volume of your oral syringe is smaller than your prescribed dose, you will have to repeat these steps to get your full dose.
Danish: Hvis den orale sprøjte ikke kan indeholde hele din ordinerede dosis, skal du gentage disse trin for at få den fulde dosis.
English: • tests show prothrombin time is longer
Danish: • tests viser længere protrombintid
English: • probenecid - to treat high levels of uric acid in the blood which can cause gout (‘hyper uricaemia')
Danish: • probenecid - anvendes til at behandle høje niveauer af urinsyre i blodet, som kan forårsage urinsyregigt (hyperurikæmi)
English: Patients should not drive or use machines whilst experiencing these side effects.
Danish: Patienter bør ikke føre motorkøretøj eller betjene maskiner, så længe de har disse bivirkninger.
English: • tests show low albumin in your blood
Danish: • tests viser lavt albumin i blodet
English: Patients should be advised to have a sufficient quantity of syringes on hand.
Danish: Patienter bør rådes til at have et tilstrækkeligt antal sprøjter tilgængelige.
English: • Utilise an oral syringe to withdraw the prescribed dosage of RAVICTI from the bottle.
Danish: • Anvend en oral sprøjte til at trække den ordinerede dosis RAVICTI ud af flasken.
English: However, dosing in UCD patients must be individualized based on the specific metabolic needs and residual enzyme capacity of the patient, irrespective of gender.
Danish: Fastlæggelse af dosis hos UCD-patienter skal dog baseres individuelt på patientens specifikke metaboliske behov og den resterende enzymkapacitet uden hensyntagen til køn.
English: There was one additional patient who had one venous ammonia level that exceeded 100 micromol/L which was not associated with a hyperammonemic crisis.
Danish: Der var en yderligere patient, som havde et venøst ammoniakniveau, der oversteg 100 mikromol/l, som ikke var forbundet med en hyperammoniæmisk krise.
English: • increased number of platelets (tends to cause blood clot)
Danish: • øget antal blodplader (kan forårsage blodpropper)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (STANDARD PACK)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (STANDARDPAKKE)
English: Use an oral syringe to measure your dose.
Danish: Brug en oral sprøjte til at afmåle dosen.