FrancophonIA/ELRC3.0 huggingface dataset:
English: Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Protein binding of silodosin glucuronide is 91%.
Danish: Silodosinglukuronids proteinbinding er 91 %.
English: • The treatment with Silodosin Recordati may lead to an abnormal ejaculation (decrease in the amount of semen released during sex) that may temporarily affect male fertility.
Danish: • Behandling med Silodosin Recordati kan føre til unormal ejakulation (reduktion i mængden af sæd, der frigives under samleje), hvilket midlertidigt kan påvirke den mandlige frugtbarhed.
English: This effect disappears after discontinuation of Silodosin Recordati.
Danish: Denne virkning forsvinder, når behandlingen med Silodosin Recordati ophører.
English: In a placebo-controlled study in 24 subjects 45-78 years of age receiving silodosin, the co-administration of sildenafil 100 mg or tadalafil 20 mg induced no clinically meaningful mean decreases in systolic or diastolic blood pressure, as assessed by orthostatic tests (standing versus supine).
Danish: I et placebo-kontrolleret studie af 24 patienter i alderen 45-78 år i behandling med silodosin inducerede samtidig administration af sildenafil 100 mg eller tadalafil 20 mg ingen gennemsnitlige fald i systolisk eller diastolisk blodtryk af klinisk betydning ved en vurdering ved hjælp af ortostatiske studier (stående versus liggende på ryggen).
English: In the long-term open-label extension phase of these controlled studies, in which patients received silodosin for up to 1 year, the symptom improvement induced by silodosin at week 12 of treatment was maintained over 1 year.
Danish: I den langvarige åbne forlængelsesfase i disse kontrollerede studier fik patienterne silodosin i op til 1 år.
English: This effect disappears after discontinuation of silodosin (see section 4.8).
Danish: Denne virkning forsvinder efter seponering af silodosin (se pkt.
English: Plasma level monitoring in a Phase III clinical study showed that levels of total silodosin after 4 weeks of treatment did not change in patients with mild impairment (n = 70), compared to patients with normal renal function (n = 155), while the levels were doubled on average in patients with moderate impairment (n = 7).
Danish: Overvågning af plasmaniveauerne i et klinisk Fase III-studie viste, at niveauerne af total silodosin efter 4 ugers behandling ikke ændrede sig hos patienter med let nedsat nyrefunktion (n = 70), sammenlignet med patienter med normal nyrefunktion (n = 55), mens niveauerne i gennemsnit var dobbelt så store hos patienter med moderat nedsat nyrefunktion (n = 7).
English: Talk to your doctor or pharmacist before taking Silodosin Recordati
Danish: Kontakt lægen eller apotekspersonalet, før De tager Silodosin Recordati.
English: No dose adjustment is required in the elderly (see section 5.2).
Danish: Ældre Det er ikke nødvendigt at justere dosis hos ældre (se pkt.
English: The exposure to the main metabolite in plasma, silodosin glucuronide (KMD-3213G), at steady-state is about 3-fold that of the parent substance.
Danish: Eksponeringen over for den primære metabolit i plasma, silodosinglukuronid (KMD-3213G) ved steady-state er ca. 3 gange så høj som over for det oprindelige stof.
English: • Decreased sexual drive
Danish: • Nedsat sexlyst
English: Silodosin Recordati does not treat prostate cancer.
Danish: Silodosin Recordati kan ikke anvendes til at behandle prostatakræft.
English: PDE-5 inhibitors
Danish: PDE-5-hæmmere
English: Do not take Silodosin Recordati if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal De vide, før De begynder at tage Silodosin Recordati Tag ikke Silodosin Recordati hvis De er allergisk over for silodosin eller et af de øvrige indholdsstoffer i Silodosin Recordati (angivet i punkt 6).
English: No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let nedsat nyrefunktion (CLCR ≥ 50 til ≤ 80 ml/min).
English: If ingestion is recent, induction of vomiting or gastric lavage may be considered.
Danish: Hvis indtagelsen af en overdosis er sket for nylig, kan det overvejes at fremprovokere opkastning eller foretage ventrikeltømning.
English: Accordingly, no dose adjustment is required in patients with mild renal impairment.
Danish: Derfor er det ikke nødvendigt at justere dosis hos patienter med let nedsat nyrefunktion.
English: Skin rash1, Pruritus1
Danish: Hududslæt1, Pruritus1
English: Silodosin Recordati may reduce the amount of sperm, and so could temporarily affect your ability to father a child.
Danish: Silodosin Recordati kan nedsætte mængden af sædceller og dermed midlertidigt påvirke Deres evne til at gøre en kvinde gravid.
English: Effects in animals (affecting the thyroid gland in rodents) were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
Danish: I dyrestudier (påvirker skjoldbruskkirtlen hos gnavere) blev der kun iagttaget virkninger af doser, der anses for at overstige den maksimale humane eksponering i væsentlig grad.
English: Silodosin Recordati is not intended for use by women.
Danish: Silodosin Recordati er kun beregnet til brug hos mænd.
English: The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Danish: Øvrige indholdsstoffer: pregelatineret majsstivelse, mannitol (E421), magnesiumstearat, natriumlaurilsulfat, gelatine, titandioxid (E171), gul jernoxid (E172).
English: Concomitant use with potent CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir or cyclosporine) is not recommended.
Danish: Potente CYP3A4-hæmmere (såsom ketoconazol, itraconazol, ritonavir eller ciclosporin) bør ikke anvendes samtidig med Silodosin Recordati.
English: The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171).
Danish: Øvrige indholdsstoffer: pregelatineret majsstivelse, mannitol (E421), magnesiumstearat, natriumlaurilsulfat, gelatine, titandioxid (E171).
English: In a single-dose study, exposure to silodosin (unbound) in subjects with mild (n = 8) and moderate renal impairment (n = 8) resulted, on average, in an increase of Cmax (1.6-fold) and AUC (1.7-fold) relative to subjects with normal renal function (n = 8).
Danish: I et enkeltdosisstudie resulterede eksponeringen over for silodosin (ubundet) hos patienter med let (n = 8) og moderat nedsat nyrefunktion (n = 8) i gennemsnit i en forhøjelse af Cmax (med 1,6 gange) og AUC (med 1,7 gange) i forhold til patienter med normal nyrefunktion (n = 8).
English: • Runny or blocked nose
Danish: • Løbende eller tilstoppet næse
English: Abnormal liver function tests1
Danish: Unormale leverfunktionsprøver1
English: No dose adjustment is required for patients with mild to moderate hepatic impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat leverfunktion.
English: Since no data are available in patients with severe hepatic impairment, the use of silodosin in these patients is not recommended (see sections 4.2 and 5.2).
Danish: Da der ikke foreligger data for patienter med svært nedsat leverfunktion, bør silodosin ikke anvendes til disse patienter (se pkt.
English: Since only limited experience exists in patients with moderate renal impairment (n = 35), a lower starting dose of 4 mg is recommended.
Danish: Da der kun er begrænset erfaring med patienter med moderat nedsat nyrefunktion (n = 35), anbefales en lavere startdosis på 4 mg. Silodosin Recordati bør ikke anvendes til patienter med svært nedsat nyrefunktion.
English: Silodosin Recordati is selective for the receptors located in the prostate, bladder and urethra.
Danish: Silodosin Recordati påvirker nogle receptorer, som findes i blærehalskirtlen, blæren og urinrøret.
English: • Faster heart rate
Danish: • Hurtigere puls
English: Allergictype reactions including facial swelling, swollen tongue and pharyngeal oedema1
Danish: Allergilignende reaktioner herunder hævelse af ansigt og tunge og faryngealt ødem1
English: Orthostatic effects
Danish: Ortostatiske virkninger
English: For this purpose Silodosin Recordati 4 mg hard capsules are available.
Danish: Til dette formål findes Silodosin Recordati 4 mg hårde kapsler.
English: If you have taken more than one capsule, inform your doctor as soon as possible.
Danish: Fortæl det til Deres læge så hurtigt som muligt, hvis De har taget flere end én kapsel.
English: Libido decreased
Danish: Nedsat libido
English: In an interaction study, a 3.7-fold increase in maximum silodosin plasma concentrations and a 3.1-fold increase in silodosin exposure (i.e. AUC) were observed with concurrent administration of a potent CYP3A4 inhibitor (ketoconazole 400 mg).
Danish: I et interaktionsstudie blev der ved samtidig administration af en potent CYP3A4-hæmmer (ketoconazol 400 mg) observeret en forhøjelse på 3,7 gange af silodosins maksimale plasmakoncentrationer og en forhøjelse i silodosin-eksponering på 3,1 gange (dvs. AUC).
English: Unite d Kingdom Recordati Pharmaceuticals Ltd. Tel: + 44 1491 576336
Danish: Recordati Pharmaceuticals Ltd. Tel: + 44 1491 576336
English: A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CLCR 30 to < 50 mL/min), which may be increased to 8 mg once daily after one week of treatment, depending on the individual patient's response.
Danish: Denne dosis kan forøges til 8 mg én gang dagligt efter en uges behandling, afhængig af den enkelte patients respons.
English: De uts chland Recordati Pharma GmbH Tel: + 49 731 70470
Danish: Recordati Pharma GmbH Tel: + 49 731 70470
English: The recommended dose is one capsule of Silodosin Recordati 8 mg daily.
Danish: Den anbefalede dosis er én kapsel Silodosin Recordati 8 mg dagligt.
English: Diarrhoea Nausea Dry mouth
Danish: Kvalme Mundtørhed
English: The initiation of therapy with silodosin is not recommended in patients for whom cataract surgery is scheduled.
Danish: Der bør ikke påbegyndes behandling med silodosin hos patienter med en planlagt operation for grå stær.
English: The recommended dose is one capsule of Silodosin Recordati 8 mg per day by oral administration.
Danish: Den anbefalede dosis er en kapsel Silodosin Recordati 8 mg pr. dag givet oralt (gennem munden).
English: Silodosin Recordati 8 mg hard capsules Each hard capsule contains 8 mg silodosin.
Danish: Silodosin Recordati 8 mg hårde kapsler Hver hård kapsel indeholder 8 mg silodosin.
English: Tachycardia1 Palpitations1
Danish: Takykardi1
English: Other medicines and Silodosin Recordati
Danish: Brug af anden medicin sammen med Silodosin Recordati
English: Silodosin is excreted mainly as metabolites, very low amounts of unchanged drug are recovered in urine.
Danish: Det er kun meget små mængder uændret lægemiddel, der kan genfindes i urinen.
English: If you forget to take Silodosin Recordati
Danish: Hvis De har glemt at tage Silodosin Recordati
English: If you stop taking Silodosin Recordati
Danish: Hvis De holder op med at tage Silodosin Recordati
English: This causes an improvement of both storage (irritative) and voiding (obstructive) symptoms (Lower urinary tract symptoms, LUTS) associated with benign prostatic hyperplasia.
Danish: Derved forbedres LUTS-symptomer (lower urinary tract symptoms), der er associeret med godartet prostatahyperplasi både med hensyn til blærens evne til at opbevare urin (irritativ) og blæretømningen (obstruktiv).
English: In clinical studies, the occurrence of ejaculation with reduced or no semen has been observed during treatment with silodosin (see section 4.8), due to the pharmacodynamic properties of silodosin.
Danish: I kliniske studier blev der observeret forekomst af ejakulat, med reduceret mængde sæd eller ingen sæd under behandlingen med silodosin (se pkt.
English: Laboratoires BOUCHARA-RECORDATI Tél: + 33 1 45 19 10 00
Danish: Tél: + 33 1 45 19 10 00
English: Each capsule contains 4 mg of silodosin.
Danish: Hver kapsel indeholder 4 mg silodosin.
English: Each capsule contains 8 mg of silodosin.
Danish: Hver kapsel indeholder 8 mg silodosin.
English: Silodosin Recordati 4 mg and 8 mg hard capsules Capsule content
Danish: Silodosin Recordati 4 mg og 8 mg hårde kapsler Kapselindhold
English: What Silodosin Recordati is and what it is used for What you need to know before you take Silodosin Recordati How to take Silodosin Recordati Possible side effects
Danish: Det skal De vide, før De begynder at tage Silodosin Recordati Sådan skal De tage Silodosin Recordati Bivirkninger
English: Silodosin Recordati 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
Danish: Silodosin Recordati 4 mg er gule, uigennemsigtige, hårde gelatinekapsler, størrelse 3 (cirka 15,9 x 5,8 mm).
English: Silodosin Recordati 4 mg hard capsules Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8 mm).
Danish: Silodosin Recordati 4 mg hårde kapsler Gul, uigennemsigtig, hård gelatinekapsel, størrelse 3 (cirka 15,9 x 5,8 mm).
English: Silodosin Recordati 8 mg hard capsules White, opaque, hard gelatin capsule, size 0 (approximately 21.7 x 7.6 mm).
Danish: Silodosin Recordati 8 mg hårde kapsler Hvid, uigennemsigtig, hård gelatinekapsel, størrelse 0 (cirka 21,7 x 7,6 mm).
English: Silodosin Recordati 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Danish: Silodosin Recordati 8 mg er hvide, uigennemsigtige, hårde gelatinekapsler, størrelse 0 (cirka 21,7 x 7,6 mm).
English: Syncope Loss of consciousness1
Danish: Synkope Bevidstløshed1
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Silodosin Recordati 4 mg hard capsules Each hard capsule contains 4 mg silodosin.
Danish: Silodosin Recordati 4 mg hårde kapsler Hver hård kapsel indeholder 4 mg silodosin.
English: What Silodosin Recordati is used for
Danish: Silodosin Recordatis anvendelse
English: INFORMATION IN BRAILLE silodosin recordati 4 mg
Danish: silodosin recordati 4 mg
English: Silodosin Recordati 8 mg hard capsules Silodosin Recordati 4 mg hard capsules silodosin
Danish: Silodosin Recordati 4 mg hårde kapsler Silodosin Recordati 8 mg hårde kapsler
English: IFIS has been reported during cataract surgery (see section 4.4).
Danish: Intraoperativt Floppy-iris-syndrom (IFIS) IFIS er blevet indberettet under operation for grå stær (se pkt.
English: How to take Silodosin Recordati
Danish: Sådan skal De tage Silodosin Recordati
English: The use of silodosin in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.2 and 5.2).
Danish: Silodosin bør ikke anvendes til patienter med svært nedsat nyrefunktion (CLCR < 30 ml/min) (se pkt.
English: INFORMATION IN BRAILLE silodosin recordati 8 mg
Danish: silodosin recordati 8 mg
English: B e lgië/Belgique/Belgien Recordati Ireland Ltd.
Danish: België/Belgique/Belgien
English: The use in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.4 and 5.2).
Danish: Lægemidlet bør ikke anvendes til patienter med svært nedsat nyrefunktion (CLCR < 30 ml/min) (se pkt.
English: Puh/Tel: + 353 21 4379400
Danish: Tlf: + 353 21 4379400
English: Silodosin Recordati 8 mg hard capsules
Danish: Silodosin Recordati 8 mg hårde kapsler silodosin
English: As no data are available, the use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2).
Danish: Bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Silodosin Recordati 4 mg hard capsules silodosin
Danish: Silodosin Recordati 4 mg hårde kapsler silodosin
English: If you feel that your sexual life is affected, please tell your doctor.
Danish: Tal med lægen, hvis De føler, at Deres seksualliv er påvirket.
English: France
Danish: Deutschland
English: Recordati Industria Chimica e Farmaceutica S.p.A. Tel: + 39 02 487871
Danish: Tel: + 39 02 487871
English: How to store Silodosin Recordati Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger Silodosin Recordati indeholder:
English: Date of first authorisation: 24 January 2003 Date of renewal: 20 May 2008
Danish: Dato for første tilladelse: 24. januar 2003 Dato for fornyelse: 20. maj 2008
English: Diffusion into erythrocytes is non existent.
Danish: Diffusion ind i erythrocytter forekommer ikke.
English: DATE OF REVISION OF THE TEXT
Danish: DATO FOR REVISION AF TEKSTEN
English: Protein binding has not been determined.
Danish: Proteinbinding er ikke fastlagt.
English: Their range was consistent with those measured in healthy adults, even in newborn infants.
Danish: Deres område var konsistent med dem, der blev målt hos raske voksne, selv hos nyfødte spædbørn.
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som De/du har.
English: Please consult your doctor for advice if you are pregnant or planning to become pregnant.
Danish: Få rådgivning af Deres læge, hvis De er gravid eller planlægger at blive gravid.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs hele denne indlægsseddel grundigt, inden De begynder at tage dette lægemiddel.
English: Like all medicines, Carbaglu can have side effects, although not everybody gets them.
Danish: Som alle lægemidler kan Carbaglu have bivirkninger, men ikke alle får bivirkninger.
English: Patients suffering from one of these disorders need treatment during the hyperammonaemia crisis.
Danish: Patienter, der lider af en af disse sygdomme, har behov for behandling under hyperammonæmi-krisen.
English: When the treatment was instituted before any permanent brain damage, patients exhibited normal growth and psychomotor development.
Danish: Når behandlingen blev igangsat inden nogen permanent hjerneskade, udviste patienterne normal vækst og psykomotorisk udvikling.
English: No specific interaction studies have been performed.
Danish: Der er ikke udført interaktionsundersøgelser.
English: These symptoms resolved once the dose was reduced.
Danish: Disse symptomer fortog sig, da først dosis blev sat ned.
English: The tablet can be divided into equal halves.
Danish: Tabletten kan deles i lige store halvdele.
English: Based on clinical experience, the treatment may be started as early as the first day of life.
Danish: Baseret på klinisk erfaring kan behandlingen begynde så tidligt som første levedag.
English: 36 months After first opening of the tablet container: 3 months
Danish: 36 måneder Efter den første åbning af tabletbeholderen: 3 måneder
English: EU/1/02/246/001 (15 dispersible tablets) EU/1/02/246/002 (60 dispersible tablets) EU/1/02/246/003 (5 dispersible tablets)
Danish: EU/1/02/246/001 (15 dispergibel tabletter) EU/1/02/246/002 (60 dispergibel tabletter) EU/1/02/246/003 (5 dispergibel tabletter)
English: The breaking of the tablets in halves allows most of the required posology adjustments.
Danish: Brækken tabletterne i halve tillader de fleste af de påkrævede doseringsjusteringer.
English: Taking Carbaglu with food and drink
Danish: Brug af Carbaglu sammen med mad og drikke
English: If you forget to take Carbaglu Do not take a double dose to make up for forgotten individual doses.
Danish: Hvis De har glemt at tage Carbaglu Tag ikke en dobbelt dosis for at udligne for den glemte individuelle dosis.
English: In order to follow-up your condition and your treatment, your doctor may examine your liver, your kidneys, your heart and your blood on a regular basis.
Danish: For at følge op på Deres tilstand og behandling vil Deres læge måske regelmæssigt undersøge leveren, nyrerne, hjertet og blodet.
English: Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Danish: Ammoniak er især toksisk for hjernen og fører i alvorlige tilfælde til nedsat bevidsthed og koma.
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Danish: De rapporterede bivirkninger er anført nedenfor efter systemorganklasse og hyppighed.
English: Discard 3 months after first opening.
Danish: Bortskaffes 3 måneder efter første åbning.
English: Caution should be exercised when prescribing to pregnant women.
Danish: Der bør udvises forsigtighed ved ordination til gravide kvinder.
English: The effects of Carbaglu on pregnancy and the unborn child are not known.
Danish: Carbaglus effekt på graviditet og det ufødte barn er ukendt.
English: Based on pharmacokinetic data and clinical experience, it is recommended to divide the total daily dose into two to four doses to be given before meals or feedings.
Danish: Baseret på farmakokinetiske data og klinisk erfaring anbefales det, at opdele den totale daglige dosis i to til fire doser, der gives inden måltider eller madning.
English: Carbaglu is indicated in treatment of
Danish: Carbaglu er indiceret til behandling af
English: The suspension has a slightly acidic taste.
Danish: Suspensionen har en let syrlig smag.
English: No adverse effects have been observed on male or female fertility.
Danish: Der er ikke observeret nogen bivirkninger på den mandlige eller den kvindelige fertilitet.
English: The maternal systemic exposures after 500 and 2000 mg/kg/day were twenty five times and seventy times the expected human exposure.
Danish: Den systemiske eksponering hos mødrene efter 500 og 2000 mg/kg/dag var 25 og 70 gange den forventede humane eksponering.
English: Whatever the daily dose, they were slowly declining over 15 hours to levels around 100 ng/ml.
Danish: Uanset den daglige dosis gik de langsomt ned i løbet af 15 timer til niveauer omkring 100 ng/ml.
English: Metabolism
Danish: Metabolisme:
English: Occasionally, the use of quarter tablets may also be useful to adjust the posology prescribed by the physician.
Danish: En gang imellem kan brugen af kvarte tabletter også være anvendelig for at justere doseringen, ordineret af lægen.
English: Nutritional management Protein restriction and arginine supplementation may be indicated in case of low protein tolerance.
Danish: Ernæringsstyring Proteinrestriktion og tilskud af arginin kan være indiceret i tilfælde af lav proteintolerance.
English: It is suggested that depending on its activity, the intestinal bacterial flora may contribute to the initiation of the degradation process, thus leading to a variable extent of metabolism of the molecule.
Danish: Det er antydet, at afhængig af aktiviteten kan den intestinale bakterielle flora bidrage til initieringen af nedbrydningsprocessen, hvilket medfører en variabel grad af metabolisme af molekylet.
English: Write the date of opening on the tablet container.
Danish: Skriv datoen for åbning på tabletbeholderen.
English: Store in a refrigerator (2C - 8C)
Danish: Opbevares i køleskab (2°C - 8°C)
English: The tablets must be dispersed in a minimum of 5 to 10 ml of water and taken immediately.
Danish: Tabletterne skal opløses i mindst 5 til 10 ml vand og tages med det samme.
English: Pharmacotherapeutic group: Amino acids and derivatives; ATC code: A16AA05
Danish: Farmakoterapeutisk klassifikation: Aminosyrer og derivater; ATC Kode: A16A A05
English: Other studies have been conducted in rats under different experimental conditions leading to increased ammonia availability (starvation, protein-free or high-protein diet).
Danish: Andre undersøgelser er blevet gennemført på rotter under forskellige eksperimentelle tilstande, ledende til øget tilgængelighed af ammoniak (sulttilstand, proteinfri eller højprotein kost).
English: Animal studies have revealed minimal developmental toxicity (see section 5.3).
Danish: Dyreforsøg har påvist minimal udviklingstoksicitet (se pkt.
English: Uncommon: bradycardia
Danish: Ikke almindelig: bradykardi
English: Plasma levels of ammonia and amino acids should be maintained within normal limits.
Danish: Plasmaniveauer af ammoniak og aminosyrer bør opretholdes indenfor de normale grænser.