FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to take AMMONAPS
Danish: Hvis du har glemt at tage AMMONAPS
English: Ammonaps 500 mg [outer packaging only]
Danish: Ammonaps 500 mg [kun ydre emballage]
English: Plasma glutamine should be maintained at levels less than 1,000 µmol/l.
Danish: Plasmaglutamin skal holdes på koncentrationer under 1000 µmol/l.
English: Talk to your doctor before taking AMMONAPS - if you have difficulty swallowing.
Danish: Kontakt lægen før du tager AMMONAPS - hvis du har svært ved at synke.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: The patient developed diarrhoea, irritability and metabolic acidosis with hypokalaemia.
Danish: Patienten udviklede diaré, irritabilitet og metabolisk acidose med hypokalæmi.
English: If persistent vomiting occurs, you should contact your doctor immediately.
Danish: Ved vedvarende opkastninger skal du straks kontakte din læge.
English: 250 tablets 500 tablets
Danish: 250 tabletter 500 tabletter
English: • 450 - 600 mg/kg/day in children weighing less than 20 kg
Danish: • 450-600 mg/kg/dag til børn, som vejer mindre end 20 kg.
English: • Pass a flat surface, e.g. the back of a knife blade, over the top of the spoon to remove the excess of granules
Danish: • Stryg en flad overflade, fx den flade side af en kniv, over toppen af skeen for at fjerne overskydende granulat
English: Each bottle contains 250 or 500 tablets.
Danish: Hver flaske indeholder 250 eller 500 tabletter.
English: AMMONAPS helps the body to eliminate nitrogen waste, reducing the amount of ammonia in your body.
Danish: AMMONAPS hjælper kroppen med at fjerne de kvælstofholdige affaldsstoffer og dermed reducere mængden af ammoniak i kroppen.
English: When the granules are dissolved in water you get a milky white liquid.
Danish: Når granulatet er opløst i vandet, opnås en mælkehvid væske.
English: The safety of this medicinal product for use in human pregnancy has not been established.
Danish: Sikkerheden ved brugen af dette produkt er ikke undersøgt hos gravide kvinder.
English: Micronucleus test results indicate that sodium phenylbutyrate was considered not to have produced any clastogenic effect in rats treated at toxic or non-toxic dose levels (examined 24 and 48 hours after a single oral administration of 878 to 2800 mg/kg).
Danish: Resultaterne af mikronukleustesten viser, at natriumphenylbutyrat ikke fremkaldte nogen klastogen effekt hos rotter, der blev behandlet med toksiske eller non-toksiske doser (undersøgt 24 og 48 timer efter en enkelt oral administration af 878 til 2800 mg/kg).
English: - if you have decreased kidney or liver function, since AMMONAPS is eliminated from the body through the kidney and liver.
Danish: - hvis du har nedsat nyrefunktion eller leverfunktion, da AMMONAPS udskilles fra kroppen igennem nyrerne og leveren.
English: What you need to know before you take AMMONAPS Do not take AMMONAPS
Danish: Det skal du vide, før du begynder at tage AMMONAPS Tag ikke AMMONAPS
English: Their cognitive performance remained relatively stable during phenylbutyrate therapy.
Danish: Deres kognitive funktion forblev relativ stabil under behandling med phenylbutyrat.
English: 532 g granules
Danish: 532 g granulat
English: AMMONAPS tablets should not be used in patients with dysphagia due to the potential risk of oesophageal ulceration if tablets are not promptly delivered to the stomach.
Danish: AMMONAPS tabletter bør ikke anvendes hos patienter med dysfagi på grund af den potentielle risiko for ulceration i esophagus, hvis tabletterne ikke straks kommer ned i mavesækken.
English: AMMONAPS is not recommended for the management of acute hyperammonaemia, which is a medical emergency.
Danish: AMMONAPS anbefales ikke til behandling af akut hyperammonæmi, som er en akut tilstand.
English: When high doses of phenylacetate (190 - 474 mg/kg) were given subcutaneously to rat pups, decreased proliferation and increased loss of neurons were observed, as well as a reduction in CNS myelin.
Danish: Da store doser phenylacetat (190-474 mg/kg) blev givet subkutant til rotteunger, blev der observeret nedsat proliferation og øget tab af neuroner samt reduktion af indholdet af myelin i CNS.
English: In children unable to swallow tablets, it is recommended to use AMMONAPS granules instead.
Danish: Til børn, som ikke er i stand til at sluge tabletter, anbefales det at bruge AMMONAPS granulat i stedet.
English: Common: Metabolic acidosis, alkalosis, decreased appetite
Danish: Almindelig: Metabolisk acidose, alkalose, nedsat appetit
English: A probable case of toxic reaction to AMMONAPS (450 mg/kg/d) was reported in an 18-year old anorectic female patient who developed a metabolic encephalopathy associated with lactic acidosis, severe hypokalaemia, pancytopaenia, peripheral neuropathy, and pancreatitis.
Danish: Et sandsynligt tilfælde af en toksisk reaktion mod AMMONAPS (450 mg/kg/dag) er indberettet for en 18-årig anorektisk kvinde, der udviklede metabolisk encefalopati associeret med lactacidose, alvorlig hypokalæmi, pancytopeni, perifer neuropati og pankreatitis.
English: The safety and efficacy of doses in excess of 20 g/day (40 tablets) have not been established.
Danish: Sikkerheden og effekten ved doser over 20 g/dag (40 tabletter) er ikke undersøgt.
English: One case of overdose occurred in a 5-month old infant with an accidental single dose of 10 g (1370 mg/kg).
Danish: Et enkelt tilfælde af overdosering indtraf hos et 5 måneder gammelt spædbarn med en utilsigtet enkelt dosis på 10 g (1370 mg/kg).
English: Each bottle contains 266 g or 532 g of granules.
Danish: Hver flaske indeholder 266 g eller 532 g granulat.
English: It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life).
Danish: Det er indiceret til alle patienter med neonatalt indsættende sygdom (komplet enzymmangel, som viser sig inden for 28 dage post partum).
English: AMMONAPS granules are off-white.
Danish: AMMONAPS granulat er off-white.
English: Prenatal exposure of rat pups to phenylacetate (the active metabolite of phenylbutyrate) produced lesions in cortical pyramidal cells; dendritic spines were longer and thinner than normal and reduced in number.
Danish: Prænatal eksponering af rotteunger for phenylacetat (den aktive metabolit af phenylbutyrat) medførte læsioner i de kortikale pyramideceller; de dendritiske udløbere var længere og tyndere end normalt og reduceret i antal.
English: The daily dose of AMMONAPS will be calculated from your protein tolerance, diet and body weight or body surface.
Danish: Den daglige dosis AMMONAPS beregnes på baggrund af din proteintolerance, kost og legemsvægt eller legemsoverflade.
English: Pharmacotherapeutic group: various alimentary tract and metabolism products, ATC code: A16A X03.
Danish: Farmakoterapeutisk klassifikation: forskellige fordøjelseskanals- og metabolismeprodukter, ATCkode: A16A X03.
English: AMMONAPS treatment should be supervised by a physician experienced in the treatment of urea cycle disorders.
Danish: Behandlingen med AMMONAPS bør kontrolleres af en læge med erfaring inden for behandling af urinstofcyklusdefekter.
English: Previously, neonatal-onset presentation of urea cycle disorders was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or their nitrogenfree analogues.
Danish: Tidligere var den neonatalt indsættende form af urinstofcyklusdefekt næsten altid dødelig inden for det første leveår, selv når det blev behandlet med peritonealdialyse og essentielle aminosyrer eller disses kvælstoffrie analoger.
English: [Justification for not including Braille accepted]
Danish: [Fritaget fra krav om brailleskrift]
English: Therapeutic monitoring: Plasma levels of ammonia, arginine, essential amino acids (especially branched chain amino acids), carnitine and serum proteins should be maintained within normal limits.
Danish: Terapeutisk kontrol: Plasmakoncentrationerne af ammoniak, arginin, essentielle aminosyrer (især aminosyrer med forgrenede sidegrupper), carnitin og serumproteiner skal holdes inden for normalområderne.
English: AMMONAPS should therefore be used with caution in patients with congestive heart failure or severe renal insufficiency, and in clinical conditions where there is sodium retention with oedema.
Danish: AMMONAPS skal derfor anvendes med forsigtighed til patienter med kongestiv hjerteinsufficiens eller svær nyreinsufficiens og ved kliniske tilstande, hvor der foreligger natriumretention med ødemdannelse.
English: - if you suffer from heart failure, a decrease in your kidney function or other diseases, where the retention of the sodium salt contained in this medicine, may make your condition worse.
Danish: - hvis du lider af hjertesvigt, nedsat nyrefunktion eller andre sygdomme, hvor ophobningen af det natriumsalt, der er i dette lægemiddel, kan forværre din tilstand.
English: Common: Renal tubular acidosis
Danish: Almindelig: Renal tubulær acidose
English: If this occurs, please discuss it with your doctor, because the absence of your period may be caused by pregnancy (see Pregnancy and breast-feeding section above).
Danish: Fortæl det til din læge, hvis dette sker, da menstruationsophøret kan skyldes, at du er gravid (se afsnittet herover om graviditet og amning).
English: In the event of an overdose, discontinue the treatment and institute supportive measures.
Danish: I tilfælde af overdosering seponeres behandlingen, og symptomatisk behandling gives.
English: OUTER CARTON AND BOTTLE LABEL FOR TABLETS
Danish: YDERPAKNING OG ETIKET TIL TABLETFLASKE
English: In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recovered from hyperammonaemic encephalopathy and were then treated chronically with dietary protein restriction and sodium phenylbutyrate, the survival rate was 98 %.
Danish: Hos patienter med sent indsættende sygdom, herunder kvinder, der var heterozygote for mangel på ornithintranscarbamylase, og som kom sig efter hyperammonæmisk encefalopati og siden blev behandlet kronisk med begrænset proteinindtagelse og natriumphenylbutyrat, var overlevelsen 98 %.
English: AMMONAPS tablets should not be given to children who are not able to swallow tablets.
Danish: AMMONAPS tabletter bør ikke gives til børn, som ikke er i stand til at sluge tabletter.
English: You should take AMMONAPS in equally divided doses by mouth, through a gastrostomy (tube that goes through the abdomen to the stomach) or through a nasogastric tube (tube that goes through the nose to the stomach).
Danish: Du skal tage AMMONAPS i ligeligt inddelte doser gennem munden, gennem en gastrostomi (en sonde, som går gennem maveskindet direkte ind i mavesækken) eller gennem en nasogastrisk sonde (en sonde, som går gennem næsen til mavesækken).
English: Do not use AMMONAPS if you are breast-feeding, because this medicine can pass into the breastmilk and harm your baby.
Danish: Tag ikke AMMONAPS, hvis du ammer, da denne medicin kan passere over i modermælken og skade dit barn.
English: The tablets are off-white, oval and embossed with “UCY 500”.
Danish: Tabletterne er off-white, ovale og præget med ”UCY 500”.
English: It has not been determined if phenylacetate is secreted in human milk and therefore the use of AMMONAPS is contra-indicated during lactation (see section 4.3).
Danish: Det er ikke fastlagt, om phenylacetat udskilles i modermælken, og derfor er brugen af AMMONAPS kontraindiceret under amning (se pkt.
English: Very common: Amenorrhoea, irregular menstruation
Danish: Meget almindelig: Amenorrhoea, uregelmæssig menstruationscyklus
English: 266 g granules
Danish: 266 g granulat
English: Package leaflet: Information for the user AMMONAPS 500 mg tablets
Danish: Indlægsseddel: Information til brugeren AMMONAPS 500 mg tabletter
English: • Take a heaped spoonful of granules out of the bottle
Danish: • Tag en skefuld med top af granulatet ud af flasken
English: AMMONAPS is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
Danish: AMMONAPS er indiceret som adjuvant behandling til den kroniske kontrol af urinstofcyklusdefekter, som involverer mangel på carbamylphosphatsyntetase, ornithintranscarbamylase eller argininosuccinatsyntetase.
English: The majority of the patients who were tested had an IQ in the average to low average/borderline mentally retarded range.
Danish: Hovedparten af patienterne, som blev undersøgt, havde en intelligenskvotient i området middel til under middel/grænsende til retardering.
English: Since the metabolism and excretion of sodium phenylbutyrate involves the liver and kidneys, AMMONAPS should be used with caution in patients with hepatic or renal insufficiency.
Danish: Da metaboliseringen og udskillelsen af natriumphenylbutyrat sker via lever og nyre, skal AMMONAPS anvendes med forsigtighed til patienter med lever- eller nyreinsufficiens.
English: AMMONAPS tablets are off-white, oval and embossed with “UCY 500”.
Danish: AMMONAPS tabletter er off-white, ovale og påtrykt “UCY 500”.
English: AMMONAPS granules should be administered orally (to infants and children unable to swallow tablets and to patients with dysphagia) or via gastrostomy or nasogastric tube.
Danish: AMMONAPS granulat skal indtages peroralt (til spædbørn og børn, som ikke kan sluge tabletter, og til patienter med dysfagi) eller via gastrostomi eller nasogastrisk sonde.
English: The granules are packaged in plastic bottles with child-resistant caps.
Danish: Granulatet er pakket i plastflasker med børnesikret låg.
English: Name and address of the manufacturer responsible for batch release PATHEON France - BOURGOIN JALLIEU 40 boulevard de Champaret
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse PATHEON France - BOURGOIN JALLIEU 40 boulevard de Champaret
English: HDPE bottles, with child resistant caps, containing 250 or 500 tablets.
Danish: HDPE-flaske med børnesikret låg med 250 eller 500 tabletter.
English: The total daily dose should be divided into equal amounts and given with each meal or feeding (e.g. 46 times per day in small children).
Danish: Den samlede daglige dosis bør inddeles i lige store mængder og indgives til hvert måltid eller madning (f.eks. 4-6 gange dagligt til små børn).
English: This will give the following doses: small measure 1.2 g, medium measure 3.3 g and large measure 9.7 g of sodium phenylbutyrate.
Danish: Dette vil give følgende doser: lille mål 1,2 g, mellemstort mål 3,3 g og stort mål 9,7 g natriumphenylbutyrat.
English: Studies with high intravenous doses of phenylacetate showed non linear pharmacokinetics characterised by saturable metabolism to phenylacetylglutamine.
Danish: Forsøg med indgift af høje doser phenylacetat intravenøst viste ikke-lineær farmakokinetik, der var karakteriseret ved saturabel metabolisme til phenylacetylglutamin.
English: Where a patient requires administration by tube, it is possible to re-constitute AMMONAPS in water prior to use (solubility for sodium phenylbutyrate is up to 5 g in 10 ml water).
Danish: Hvis en patient behøver indtagelse gennem en sonde, er det muligt at opløse AMMONAPS granulat i vand før anvendelsen (opløseligheden af natriumphenylbutyrat er op til 5 g i 10 ml vand).
English: The use of AMMONAPS tablets is indicated for adults and children who are able to swallow tablets.
Danish: AMMONAPS tabletter er indiceret til voksne og børn, som kan sluge tabletter.
English: Nitrogen waste, in the form of ammonia, is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Danish: De kvælstofholdige affaldsstoffer findes i kroppen i form af ammoniak som er specielt giftigt for hjernen og i alvorlige tilfælde kan føre til alvorlige tilfælde til bevidsthedsforstyrrelser og koma.
English: Nutritional management: AMMONAPS must be combined with dietary protein restriction and, in some cases, essential amino acid and carnitine supplementation.
Danish: Koststyring: AMMONAPS skal kombineres med indskrænkning i fødens indhold af protein og i nogle tilfælde suppleres med essentielle aminosyrer og carnitin.
English: Increased blood alkaline phosphatase, transaminases, bilirubin, uric acid, chloride, phosphate and sodium.
Danish: Øget alkalisk phosphatase, transaminaser, bilirubin, urinsyre, chlorid, phosphat og natrium i blodet.
English: The elimination half-life was estimated to be 1.2 and 2.4 hours, respectively.
Danish: Halveringstiden blev skønnet til at være henholdsvis 1,2 og 2,4 timer.
English: Common: Decreased blood potassium, albumin, total protein and phosphate.
Danish: Almindelig: Nedsat niveau af kalium, albumin, total protein og phosphat i blodet.
English: Nitrogen is a building block of proteins, because of this, there is a build up of nitrogen in the body after eating protein.
Danish: Kvælstof er en af byggestenene i proteiner, og derfor ophobes der kvælstof i kroppen, når man har indtaget proteiner.
English: The granules are off-white.
Danish: Granulat Granulatet er off-white.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedsgruppe skal bivirkningerne opstilles efter, hvor alvorlige de er.
English: - when given to small children, since they may not be able to swallow the tablets and may choke.
Danish: - hvis AMMONAPS gives til små børn, da de måske ikke kan sluge tabletterne og kan kvæles.
English: The tablets are packaged in plastic bottles with child-resistant caps.
Danish: Tabletterne er pakket i plastflasker med børnesikret låg.
English: Contents of the pack and other information What AMMONAPS contains
Danish: Pakningsstørrelser og yderligere oplysninger AMMONAPS indeholder:
English: When taken orally, the granules are to be mixed with solid foods (such as mashed potatoes or apple sauce) or liquid foods (such as water, apple juice, orange juice or protein-free infant formulas).
Danish: Når granulatet indtages peroralt, skal det blandes med fast føde (fx kartoffelmos eller æblemos) eller flydende føde (fx vand, æblejuice, appelsinjuice eller proteinfri modermælkserstatning).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om AMMONAPS findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Package leaflet: Information for the user AMMONAPS 940 mg/g granules
Danish: Indlægsseddel: Information til brugeren AMMONAPS 940 mg/g granulat
English: Three dosing spoons are provided which dispense 1.2 g, 3.3 g or 9.7 g of sodium phenylbutyrate.
Danish: Der medfølger tre doseringsskeer, som afmåler 1,2 g, 3,3 g eller 9,7 g natriumphenylbutyrat.
English: Common: Oedema Uncommon: Arrhythmia
Danish: Almindelig: Ødem Ikke almindelig: Arytmi
English: AMMONAPS is prescribed to patients with urea cycle disorders.
Danish: AMMONAPS ordineres til patienter, der lider af forstyrrelser i urinstofcyklus.
English: AMMONAPS is also available as granules for infants, children who are unable to swallow tablets and for patients with dysphagia.
Danish: AMMONAPS findes også som granulat til spædbørn, børn der ikke kan sluge tabletter, og til patienter med dysfagi.
English: With haemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in new-borns diagnosed after birth (but within the first month of life) increased to almost 80 % with most deaths occurring during an episode of acute hyperammonaemic encephalopathy.
Danish: Med hæmodialyse, brug af alternative udskillelsesveje for kvælstofaffald (natriumphenylbutyrat, natriumbenzoat og natriumphenylacetat), restriktiv proteinindtagelse med føden og i nogle tilfælde tilskud af essentielle aminosyrer steg overlevelsen for nyfødte, som blev diagnosticeret efter fødslen (men inden for den første levemåned), til næsten 80 %, hvor de fleste dødsfald skete under et tilfælde med akut hyperammonæmisk encefalopati.
English: Common: Anaemia, thrombocytopenia, leukopenia, leukocytosis, thrombocytosis Uncommon: Aplastic anaemia, ecchymosis
Danish: Almindelig: Anæmi, thrombocytopeni, leukopeni, leukocytose, thrombocytose Ikke almindelig: Aplastisk anæmi, ekkymose
English: Less frequent manifestations were confusion, headache, dysgeusia, hypacusis, disorientation, impaired memory and exacerbation of a pre-existing neuropathy.
Danish: Mindre hyppige manifestationer var konfusion, hovedpine, smagsforstyrrelser, hørenedsættelse, desorientering, svækket hukommelse og forværring af allerede eksisterende neuropati.
English: Mix the measured dose with solid foods (such as mashed potatoes or apple sauce) or liquid foods (such as water, apple juice, orange juice or protein-free infant formulas) and take it immediately after mixing.
Danish: Bland den opmålte dosis med fast føde (fx kartoffelmos eller æblemos) eller flydende føde (fx vand, æblejuice, appelsinjuice eller proteinfri modermælkserstatning) og tag det straks, efter det er blandet.
English: HDPE bottles, with child resistant caps, containing 266 g or 532 g of granules.
Danish: HDPE-glas med børnesikret låg med 266 g eller 532 g granulat.
English: Talk to your doctor before taking AMMONAPS - if you suffer from heart failure, a decrease in your kidney function or other diseases where the retention of the sodium salt contained in this medicine may make your condition worse.
Danish: Kontakt lægen eller apotekspersonalet før du tager AMMONAPS - hvis du lider af hjertesvigt, nedsat nyrefunktion eller andre sygdomme, hvor ophobningen af det natriumsalt, der er i dette lægemiddel, kan forværre din tilstand.
English: Effective contraceptive measures must be taken by women of child-bearing potential.
Danish: Effektiv antikonception skal bruges af kvinder i den fertile alder. Amning
English: It is recommended that a heaped measuring spoon is removed from the container and a flat surface, e.g. the blade of a knife, is drawn across the top of the measure.
Danish: Det anbefales, at man tager en skefuld med top af granulatet, hvorefter man stryger fx den flade side af en kniv over toppen af målet.
English: Patients with a gastrostomy or nasogastric tube
Danish: Patienter med gastrostomi eller nasogastrisk sonde
English: Patients who have taken very high doses of AMMONAPS experienced: - sleepiness, tiredness, light-headedness and less frequently confusion, - headache, - changes in taste (taste disturbances), - decrease in hearing, - disorientation, - impaired memory, - worsening of existing neurological conditions.
Danish: Patienter, der har taget meget store doser AMMONAPS, oplever: - søvnighed, træthed, svimmelhed og mindre hyppigt forvirring - hovedpine - smagsforstyrrelser - nedsat hørelse - desorientering - svækket hukommelse - forværring af eksisterende neurologiske tilstande.
English: AMMONAPS 500 mg tablets.
Danish: AMMONAPS 500 mg tabletter
English: Common side effects: changes in number of blood cells (red cells, white cells and platelets), reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disturbances),pain in the abdomen, vomiting, nausea, constipation, skin odour, rash, abnormal kidney function, weight gain, altered laboratory test values.
Danish: Almindelige bivirkninger: ændringer i antallet af blodlegemer (røde blodlegemer, hvide blodlegemer og blodplader), nedsat appetit, depression, irritabilitet, hovedpine, besvimelse, væskeophobning (hævelse), smagsforstyrrelser, mavesmerter, opkastning, kvalme, forstoppelse, unormal kropslugt, udslæt, unormal nyrefunktion, vægtstigning, ændrede resultater af laboratorieanalyser.
English: OUTER CARTON AND BOTTLE LABEL FOR GRANULES
Danish: YDERPAKNING OG ETIKET TIL GRANULATFLASKE