FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of pregabalin.
Slovenian: Ena trda kapsula vsebuje 50 mg pregabalina.
English: Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white coloured powder.
Slovenian: Neprozorna pokrovček in telo rdeče barve, velikost kapsule 3 (15,9 mm x 5,8 mm), napolnjena s praškom bele do belkaste barve.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 25 mg hard capsules
Slovenian: Pregabalin Sandoz 25 mg trde kapsule
English: Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules.
Slovenian: Pretisni omoti, ki vsebujejo 14, 21, 28, 56, 70, 84, 100 ali 120 trdih kapsul.
English: Blisters containing 14, 21, 28, 56, 84 or 100 hard capsules.
Slovenian: Pretisni omoti, ki vsebujejo 14, 21, 28, 56, 84 ali 100 trdih kapsul.
English: 14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 56 x 1 hard capsules
Slovenian: 14 trdih kapsul 21 trdih kapsul 28 trdih kapsul 56 trdih kapsul 70 trdih kapsul 56 x 1 trda kapsula
English: • Dilated pupils, cross eyes.
Slovenian: • Razširjene zenice, škiljenje.
English: Blisters containing 14, 28, 56, 70, 84, 100 or 120 hard capsules.
Slovenian: Pretisni omoti, ki vsebujejo 14, 28, 56, 70, 84, 100 ali 120 trdih kapsul.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 50 mg hard capsules
Slovenian: Pregabalin Sandoz 50 mg trde kapsule
English: Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to nearly white coloured powder.
Slovenian: Neprozorna pokrovček in telo svetlo oranžne barve, velikost kapsule 1 (19,4 mm x 6,9 mm), napolnjena s praškom bele do belkaste barve.
English: INFORMATION IN BRAILLE Pregabalin Sandoz 200 mg
Slovenian: Pregabalin Sandoz 200 mg
English: Light yellow opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white coloured powder.
Slovenian: Neprozorna pokrovček in telo svetlorumene barve, velikost kapsule 3 (15,9 mm x 5,8 mm), napolnjena s praškom bele do belkaste barve.
English: INFORMATION IN BRAILLE Pregabalin Sandoz 100 mg
Slovenian: Pregabalin Sandoz 100 mg
English: 14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 14 x 1 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Slovenian: 14 trdih kapsul 21 trdih kapsul 28 trdih kapsul 56 trdih kapsul 70 trdih kapsul 84 trdih kapsul 100 trdih kapsul 120 trdih kapsul 14 x 1 trda kapsula 56 x 1 trda kapsula 84 x 1 trda kapsula 100 x 1 trda kapsula
English: 14 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Slovenian: 14 trdih kapsul 28 trdih kapsul 56 trdih kapsul 70 trdih kapsul 84 trdih kapsul 100 trdih kapsul 120 trdih kapsul 56 x 1 trda kapsula 84 x 1 trda kapsula 100 x 1 trda kapsula
English: Pale orange opaque cap and white opaque body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to nearly white coloured powder.
Slovenian: Neprozorni pokrovček svetlo oranžne barve in neprozorno telo bele barve, velikost kapsule 1 (19,4 mm x 6,9 mm), napolnjena s praškom bele do belkaste barve.
English: • Inflammation of the pancreas.
Slovenian: • Epileptični krči.
English: • There have been reports of kidney failure in some patients when taking pregabalin .
Slovenian: • Pri nekaterih bolnikih, ki so jemali pregabalin, so opisani primeri odpovedi ledvic.
English: Pale yellow-brown opaque cap and body, capsule size 4 (14.3 mm x 5.3 mm), filled with white to nearly white coloured powder.
Slovenian: Neprozorna pokrovček in telo blede rumenkasto-rjave barve, velikost kapsule 4 (14,3 mm x 5,3 mm), napolnjena s praškom bele do belkaste barve.
English: 14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Slovenian: 14 trdih kapsul 21 trdih kapsul 28 trdih kapsul 56 trdih kapsul 70 trdih kapsul 84 trdih kapsul 100 trdih kapsul 120 trdih kapsul 56 x 1 trda kapsula 84 x 1 trda kapsula 100 x 1 trda kapsula
English: Multipack: 84 (2 packs of 42) hard capsules Multipack: 100 (2 packs of 50) hard capsules Multipack: 120 (2 packs of 60) hard capsules Multipack: 84 x 1 (2 packs of 42 x 1) hard capsules Multipack: 100 x 1 (2 packs of 50 x 1) hard capsules Multipack: 210 x 1 (3 packs of 70 x 1) hard capsules
Slovenian: Pretisni omoti (posamezni odmerki): 56 x 1, 84 x 1 (2 x 42), 100 x 1 (2 x 50) ali 210 x 1 (3 x 70) trdih kapsul.
English: 14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Slovenian: 14 trdih kapsul 21 trdih kapsul 28 trdih kapsul 56 trdih kapsul 84 trdih kapsul 100 trdih kapsul 84 x 1 trda kapsula 100 x 1 trda kapsula
English: INFORMATION IN BRAILLE Pregabalin Sandoz 50 mg
Slovenian: Pregabalin Sandoz 50 mg
English: It is advised not to drink alcohol while taking Pregabalin Sandoz.
Slovenian: Če jemljete zdravilo Pregabalin Sandoz, odsvetujemo pitje alkohola.
English: INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz 150 mg
Slovenian: Škatla: Pregabalin Sandoz 150 mg
English: Blister packs: 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules Blister packs (unit dose): 56 x 1, 84 x 1 (2 x 42), 100 x 1 (2 x 50) or 210 x 1 (3 x 70) hard capsules Container packs: 100, 200 or 250 hard capsules
Slovenian: Pretisni omoti: 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) ali 120 (2 x 60) trdih kapsul.
English: Blister packs: 21, 28, 84 or 100 hard capsules Blister packs (unit dose): 84 x 1 or 100 x 1 hard capsules Not all pack sizes may be marketed.
Slovenian: Pretisni omoti (posamezni odmerki): 84 x 1 ali 100 x 1 trdih kapsul.
English: In small children this can be 4 to 6 times per day.
Slovenian: Pri majhnih otrocih je to lahko 4 do 6-krat dnevno.
English: Frequency cannot be estimated from the available data
Slovenian: ni mogoče oceniti iz razpoložljivih podatkov
English: Date of first authorisation: 08/12/1999 Date of latest renewal: 08/12/2009
Slovenian: Datum prve pridobitve: 08/12/1999 Datum zadnjega podaljšanja: 08/12/2009
English: Immedica Pharma AB SE-113 29 Stockholm Sweden
Slovenian: Immedica Pharma AB SE-113 29 Stockholm Švedska
English: Make sure that there are at least 3 hours between two doses.
Slovenian: Prepričajte se, da so minile najmanj 3 ure med dvema odmerkoma.
English: Your doctor will tell you how many tablets you should take.
Slovenian: Vaš zdravnik vam bo povedal, koliko tablet morate vzeti.
English: Three measuring spoons of different measures are provided.
Slovenian: Priložene so tri merilne žličke različnih mer.
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).
Slovenian: Če se to zgodi, se posvetujete s svojim zdravnikom, ker lahko izostanek menstruacije pomeni, da ste noseči (glejte poglavje Nosečnost in dojenje zgoraj).
English: The tablets should be taken with a large volume of water.
Slovenian: Zdravilo je treba jemati z veliko količino vode.
English: Your doctor will tell you the amount of granules you should take.
Slovenian: Zdravnik vam bo povedal količino zrnc, ki jih morate vzeti.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle label after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na plastenki poleg oznake “EXP”.
English: Patients with these rare disorders have a deficiency of certain liver enzymes and are therefore unable to eliminate nitrogen waste.
Slovenian: Bolniki s temi redkimi motnjami imajo premalo določenih encimov v jetrih in zato ne morejo odstranjevati odpadnega dušika.
English: You will need regular blood tests to determine the correct daily dose.
Slovenian: Opravljati boste morali redne krvne preiskave, da se bo določil pravilni dnevni odmerek zdravila AMMONAPS.
English: These medicines may change the effect of AMMONAPS and you will need more frequent blood controls.
Slovenian: Ta zdravila lahko spremenijo delovanje zdravila AMMONAPS in boste morali pogosteje na preiskave krvi.
English: - if you are pregnant.
Slovenian: - če ste noseči, - če dojite,
English: The volume of distribution of phenylbutyrate is 0.2 l/kg.
Slovenian: Volumen porazdelitve fenilbutirata je 0,2 l/kg.
English: Evaluation of experimental animal studies has shown reproductive toxicity, i.e. effects on the development of the embryo or the foetus.
Slovenian: Študije na živalih so pokazale reproduktivno toksičnost, tj. učinkovanje na razvoj zarodka ali ploda.
English: The safety of this medicinal product for use in human pregnancy has not been established.
Slovenian: Varnost tega zdravila med nosečnostjo še ni ugotovljena.
English: Common: Syncope, headache
Slovenian: Pogosti: sinkopa, glavobol
English: If you are sexually active and your period stops altogether, do not assume that this is caused by AMMONAPS.
Slovenian: Če ste spolno dejavni in vam menstruacija izostane, ne domnevajte, da gre za učinke zdravila AMMONAPS.
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.
Slovenian: Odpadni dušik v obliki amonijaka je še posebej toksičen za možgane in v hudih primerih povzroči zmanjšano zavest in komo.
English: What AMMONAPS is and what it is used for
Slovenian: Kaj je zdravilo AMMONAPS in za kaj ga uporabljamo
English: The safety and efficacy of doses in excess of 20 g/day have not been established.
Slovenian: Varnost in učinkovitost odmerkov večjih od 20 g/dan še ni bila dokazana.
English: When the granules are dissolved in water you get a milky white liquid.
Slovenian: Ko se zrnca raztopijo v vodi, nastane mlečno bela tekočina.
English: If you require laboratory tests, it is important to remind your doctor that you are taking AMMONAPS, since sodium phenylbutyrate may influence certain laboratory test results.
Slovenian: Če boste morali opraviti laboratorijske preiskave, je pomembno, da opomnite svojega zdravnika, da jemljete zdravilo AMMONAPS, ker lahko natrijev fenilbutirat vpliva na rezultate nekaterih laboratorijskih preiskav.
English: Plasma glutamine should be maintained at levels less than 1,000 µmol/l.
Slovenian: Plazemske koncentracije glutamina se morajo vzdrževati pod 1.000 µmol/l.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: One case of overdose occurred in a 5-month old infant with an accidental single dose of 10 g (1370 mg/kg).
Slovenian: Do prevelikega odmerjanja je prišlo pri petmesečnem dojenčku z naključnim zaužitjem enkratnega odmerka 10 g (1370 mg/kg).
English: What AMMONAPS is and what it is used for What you need to know before you take AMMONAPS How to take AMMONAPS
Slovenian: Kaj je zdravilo AMMONAPS in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo AMMONAPS Kako jemati zdravilo AMMONAPS
English: The adverse reactions are listed below, by system organ class and by frequency.
Slovenian: Neželeni učinki so navedeni spodaj, razvrščeni po organskih sistemih in po pogostnosti.
English: If you forget to take AMMONAPS
Slovenian: Če ste pozabili vzeti zdravilo AMMONAPS
English: Other medicines and AMMONAPS
Slovenian: Druga zdravila in zdravilo AMMONAPS
English: 250 tablets 500 tablets
Slovenian: 250 tablet 500 tablet
English: In the event of an overdose, discontinue the treatment and institute supportive measures.
Slovenian: V primeru prevelikega odmerjanja je potrebno nemudoma prekiniti z zdravljenjem in izvesti podporne ukrepe.
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).
Slovenian: Pogostnost neželenih učinkov je opredeljena kot zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki
English: In clinical trials with AMMONAPS, 56 % of the patients experienced at least one adverse event and 78 % of these adverse events were considered as not related to AMMONAPS.
Slovenian: 4.8 Neželeni učinki V kliničnih preskušanjih z zdravilom AMMONAPS je 56 % bolnikov doživelo najmanj en neželeni dogodek, vendar se za 78 % teh neželenih dogodkov smatra, da niso povezani z zdravilom AMMONAPS.
English: Approximately 80 - 100 % of the medicinal product is excreted by the kidneys within 24 hours as the conjugated product, phenylacetylglutamine.
Slovenian: Približno 80 -100 % zdravila se izloči preko ledvic v 24 urah v obliki konjugiranega produkta, fenilacetilglutamina.
English: • 9.9 - 13.0 g/m2/day in children weighing more than 20 kg, adolescents and adults.
Slovenian: • 9,9 - 13,0 g/m2/dan pri otrocih, ki tehtajo več kot 20 kg, ter pri mladostnikih in pri odraslih.
English: The safety and efficacy of doses in excess of 20 g/day (40 tablets) have not been established.
Slovenian: Varnost in učinkovitost odmerkov večjih od 20 g/dan (40 tablet), še ni bila dokazana.
English: What you need to know before you take AMMONAPS Do not take AMMONAPS
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo AMMONAPS Ne jemljite zdravila AMMONAPS
English: To be taken into consideration by patients on a sodium controlled diet.
Slovenian: To morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
English: • The granules left in the spoon are one spoonful
Slovenian: • Zrnca, ki ostanejo v žlički so ena merica.
English: AMMONAPS may be required life-long unless orthotopic liver transplantation is elected.
Slovenian: Zdravljenje z zdravilom AMMONAPS je lahko potrebno celo življenje, če ne pride do odločitve za ortotopično presaditev jeter.
English: Three spoons (one small white spoon, one medium sized yellow spoon and one large blue spoon) are included to measure your daily dose.
Slovenian: Priložene so tri merilne žličke (ena majhna bela žlička, ena srednja rumena žlička in ena velika modra žlička), s katerimi odmerite svoj dnevni odmerek.
English: The daily dose should be individually adjusted according to the patient's protein tolerance and the daily dietary protein intake needed to promote growth and development.
Slovenian: Dnevni odmerek se mora prilagoditi individualno glede na bolnikovo toleranco za beljakovine in na potreben dnevni vnos beljakovin za pospeševanje rasti in razvoja.
English: You should take AMMONAPS with each meal or feeding.
Slovenian: Zdravilo AMMONAPS morate vzeti pri vsakem obroku ali hranjenju.
English: Please note that the reconstituted granules will normally produce a milky white suspension.
Slovenian: Pri suspendiranju zrnc običajno nastane mlečna bela suspenzija.
English: Cerebral synapse maturation was retarded and the number of functioning nerve terminals in the cerebrum was reduced, which resulted in impaired brain growth.
Slovenian: Opazili so tudi zakasnjeno zorenje cerebralnih sinaps in zmanjšano število delujočih živčnih končičev v možganih ter posledično zmanjšano rast možganov.
English: Ammonaps 500 mg [outer packaging only]
Slovenian: Ammonaps 500 mg [samo zunanja ovojnina]
English: Where AMMONAPS granules need to be added to food, liquid or water, it is important that it is taken immediately after mixing.
Slovenian: Pri bolnikih, kjer se zdravilo AMMONAPS dodaja hrani, tekočinam ali vodi, je pomembno, da se zdravilo vzame takoj po vmešanju.
English: Each bottle contains 250 or 500 tablets.
Slovenian: Vsaka plastenka vsebuje 250 ali 500 tablet.
English: AMMONAPS is not recommended for the management of acute hyperammonaemia, which is a medical emergency.
Slovenian: Zdravila AMMONAPS ne priporočajo za zdravljenje akutne hiperamonemije, ki je medicinski nujen primer.
English: Reversal of pre-existing neurologic impairment is not likely to occur with treatment, and neurologic deterioration may continue in some patients.
Slovenian: Z zdravljenjem ni verjetno, da bi prišlo do izboljšanja obstoječih nevroloških motenj, pri nekaterih bolnikih se lahko tudi nadaljuje slabšanje nevroloških stanj.
English: Manifestations of neurotoxicity were predominantly somnolence, fatigue and light-headedness.
Slovenian: Znaki nevrotoksičnosti so bili predvsem somnolenca, utrujenost, omotičnost.
English: There have been published reports of hyperammonaemia being induced by haloperidol and by valproate.
Slovenian: Objavljena so poročila o hiperamonemiji inducirani s haloperidolom in z valproatom.
English: AMMONAPS treatment should be supervised by a physician experienced in the treatment of urea cycle disorders.
Slovenian: Zdravljenje z zdravilom AMMONAPS naj nadzoruje zdravnik, ki je izkušen pri zdravljenju motenj ciklusa sečnine.
English: If persistent vomiting occurs, you should contact your doctor immediately.
Slovenian: Če začnete vztrajno bruhati, nemudoma obvestite svojega zdravnika.
English: It is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
Slovenian: Indicirano je tudi pri bolnikih, pri katerih se bolezen pojavi s t.i. zakasnjenim pojavom (delne pomanjkljivosti encimov, ki se pokažejo po prvem mesecu življenja) in imajo anamnezo hiperamonemične encefalopatije.
English: Their cognitive performance remained relatively stable during phenylbutyrate therapy.
Slovenian: Njihove kognitivne sposobnosti pa so med zdravljenjem z fenilbutiratom ostajale relativno stabilne.
English: AMMONAPS helps the body to eliminate nitrogen waste, reducing the amount of ammonia in your body.
Slovenian: Zdravilo AMMONAPS telesu pomaga odstraniti odpadni dušik in v njem zmanjšati količino amonijaka.
English: The majority of the patients who were tested had an IQ in the average to low average/borderline mentally retarded range.
Slovenian: Vrednosti IQ večine bolnikov, ki so bili testirani, so bile v območju povprečja do območja nizkega povprečja oz. mejne umske zaostalosti.
English: The granules are off-white.
Slovenian: Zrnca so sivo bela.
English: You will need to have treatment and to follow a diet throughout your life, unless you have a successful liver transplantation.
Slovenian: Zdravljenje in posebno prehrano boste potrebovali celo življenje, če vam ne bodo uspešno presadili jeter.
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.
Slovenian: S hemodializo, uporabo alternativnih poti izločanja odpadnega dušika (natrijev fenilbutirat, natrijev benzoat in natrijev fenilacetat), omejevanjem prehranskega vnosa beljakovin in (v določenih primerih) dopolnili esencialnih aminokislin se je stopnja preživetja pri novorojenčkih s postavitvijo diagnoze v prvem mesecu življenja povečala na skoraj 80 %; pri čemer do večine smrti pride med epizodo hiperamoniemične encefalopatije.
English: - if you have decreased kidney or liver function, since AMMONAPS is eliminated from the body through the kidney and liver.
Slovenian: - če imate zmanjšano delovanje ledvic ali jeter, ker se zdravilo AMMONAPS odstranjuje iz telesa preko ledvic in jeter.
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.
Slovenian: Pri dajanju visokih odmerkov fenilacetata (190 - 474 mg/kg) podganjim mladičem podkožno, so opazili zmanjšano proliferacijo nevronov in pospešeno izgubo le-teh. Skrčil se je tudi mielin v CŽS.
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.
Slovenian: Nadzorovanje zdravljenja: Plazemske koncentracije amoniaka, arginina, esencialnih aminokislin (predvsem razvejane verige aminokislin), karnitina in serumskih beljakovin se morajo vzdrževati v normalnih mejah.
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.
Slovenian: - če vam odpoveduje srce, če imate zmanjšano delovanje ledvic ali druge bolezni, kjer lahko zadrževanje natrijeve soli, ki jo vsebuje to zdravilo, poslabša vaše stanje.
English: It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life).
Slovenian: Zdravilo AMMONAPS je indicirano pri vseh bolnikih, pri katerih se bolezen pojavi s t.i. neonatalnim pojavom (celotne pomanjkljivosti encimov, ki se pokažejo v prvih 28 dneh življenja).
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).
Slovenian: Ni znano ali fenilacetat prehaja v materino mleko, zato je uporaba zdravila AMMONAPS med dojenjem kontraindicirana (glejte poglavje 4.3).
English: The total daily dose of AMMONAPS should be divided into equal amounts and given with each meal (e.g. three times per day).
Slovenian: Celokupni dnevni odmerek zdravila AMMONAPS naj se razdeli na enake dele in se daje z vsakim obrokom (npr. trikrat dnevno).
English: In patients with impaired hepatic function the conversion of phenylacetate to phenylacetylglutamine may be relatively slower.
Slovenian: Pri bolnikih z motnjami v delovanju jeter je lahko pretvorba fenilacetata v fenilacetilglutamin relativno počasnejša.
English: AMMONAPS does not completely prevent the occurrence of an acute excess of ammonia in the blood and is not appropriate for treating such a condition, which is a medical emergency.
Slovenian: Zdravilo AMMONAPS ne prepreči pojava odvečnih količin amonija v krvi popolnoma in ni primeren za zdravljenje takšnega stanja, ki je medicinski nujen primer.
English: The daily dose of AMMONAPS will be calculated from your protein tolerance, diet and body weight or body surface.
Slovenian: Dnevni odmerek zdravila AMMONAPS se bo določil na podlagi vaše tolerance za beljakovine, prehrane in telesne mase ali površine.
English: Arginine supplementation is required for patients diagnosed with deficiency of argininosuccinate synthetase at a dose of 0.4 - 0.7 g/kg/day or 8.8 - 15.4 g/m2/day.
Slovenian: Dopolnjevanje prehrane z argininom je potrebno za bolnike z diagnozo pomanjkljivosti argininosukcinat-sintaze, in sicer z odmerki 0,4 - 0,7 g/kg/dan ali 8,8 - 15,4 g/m2/dan.
English: HDPE bottles, with child resistant caps, containing 250 or 500 tablets.
Slovenian: Plastenke iz HDPE z za otroke varno zaporko, ki vsebujejo 250 ali 500 tablet.
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.
Slovenian: Poročali so o verjetnem primeru toksične reakcije na zdravilo AMMONAPS (450 mg/kg/d) pri 18-letni anorektični bolnici, pri kateri se je razvila metabolična encefalopatija, povezana z laktično acidozo, težko hipokaliemijo, pancitopenijo, periferno nevropatijo in pankreatitisom.