FrancophonIA/ELRC3.0 huggingface dataset:
English: • medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Silodosin Recordati might lead to a slight decrease in blood pressure.
Croatian: • lijekove koji se primjenjuju u liječenju otežanog postizanja i održavanja erekcije (kao što su sildenafil ili tadalafil), budući da istovremeno uzimanje lijeka Silodozin Recordati može dovesti do sniženja krvnog tlaka.
English: Injury, poisoning and procedural complication
Croatian: Ozljede, trovanja i proceduralne komplikacije intraoperacijski sindrom meke šarenice
English: In the table below, adverse reactions reported in all clinical studies and in the worldwide post-marketing experience for which a reasonable causal relationship exists are listed by MedDRA system organ class and frequency: 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 available data).
Croatian: manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato
English: Silodosin and its glucuronide reach steady-state after 3 days and 5 days of treatment, respectively.
Croatian: Silodozin postiže stanje dinamičke ravnoteže nakon 3 dana, a njegov glukuronid nakon 5 dana liječenja.
English: Abnormal liver function tests1
Croatian: Poremećaji jetre i žuči abnormalni nalazi pretraga funkcije jetre1
English: The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Croatian: Drugi sastojci su prethodno geliran kukuruzni škrob, manitol (E421), magnezijev stearat, natrijev laurilsulfat, želatina, titanijev dioksid (E171), žuti željezov oksid (E172).
English: The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171).
Croatian: Drugi sastojci su prethodno geliran kukuruzni škrob, manitol (E421), magnezijev stearat, natrijev laurilsulfat, želatina, titanijev dioksid (E171).
English: The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two long-term open-label extension phase studies.
Croatian: Faze II-III (u kojima je 931 bolesnik primao silodozin od 8 mg jedanput na dan, a 733 bolesnika je primalo placebo) i u dva dugotrajna nastavka ispitivanja otvorenog tipa.
English: The use in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.4 and 5.2).
Croatian: Ne preporučuje se primjena u bolesnika s teškim oštećenjem funkcije bubrega (CLcr < 30 ml/min) (vidjeti dijelove 4.4 i 5.2).
English: This medicine contains less than 1 mmoL sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po kapsuli, tj. zanemarive količine natrija.
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.
Croatian: Izloženost glavnom metabolitu u plazmi, silodozin glukuronidu (KMD-3213G), u stanju je dinamičke ravnoteže oko 3 puta veća od one ishodišnoj tvari.
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).
Croatian: U ispitivanju jednokratne doze, izloženost silodozinu (nevezanom) u ispitanika s blagim (n = 8) i umjerenim oštećenjem funkcije bubrega (n = 8) u prosjeku je rezultiralo povećanjem Cmax (1,6 puta) i
English: Steady state levels of digoxin, a substrate of P-glycoprotein, were not significantly affected by co-administration with silodosin 8 mg once daily.
Croatian: Razine digoksina, supstrata P-glikoproteina, u stanju dinamičke ravnoteže nisu bile značajno promijenjene istovremenom primjenom silodozina od 8 mg jedanput na dan.
English: • Faster heart rate
Croatian: • brži otkucaji srca
English: In the clinical study program, many patients were on concomitant antihypertensive therapy (mostly agents acting on the renin-angiotensin system, beta-blockers, calcium antagonists and diuretics) without experiencing an increase in the incidence of orthostatic hypotension.
Croatian: (uglavnom lijekove koji djeluju na sustav renin-angiotenzin, beta-blokatore, antagoniste kalcija i diuretike), a da pritom incidencija ortostatske hipotenzije nije bila povećana.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Croatian: Natrij Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po kapsuli, tj. zanemarive količine natrija.
English: • difficulty in starting to pass water,
Croatian: • otežan početak mokrenja,
English: As no data are available, the use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2).
Croatian: Kako nema dostupnih podataka, ne preporučuje se primjena u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
English: The pharmacokinetics of silodosin in patients with severe hepatic impairment has not been studied.
Croatian: Farmakokinetika silodozina u bolesnika s teškim oštećenjem funkcije jetre nije se ispitivala.
English: Tachycardia1 Palpitations1
Croatian: Srčani poremećaji tahikardija1
English: De uts chland Recordati Pharma GmbH Tel: + 49 731 70470
Croatian: Recordati Pharma GmbH Tel: + 49 731 70470
English: Silodosin Recordati is selective for the receptors located in the prostate, bladder and urethra.
Croatian: Silodozin Recordati se selektivno veže za receptore koji se nalaze u prostati, mokraćnom mjehuru i mokraćnoj cijevi.
English: No significant reduction in supine blood pressure was observed in all clinical studies conducted with silodosin.
Croatian: Niti u jednom od kliničkih ispitivanja provedenih sa silodozinom nije bilo primijećeno značajno sniženje krvnog tlaka u ležećem položaju.
English: The pharmacokinetics of silodosin and its main metabolites have been evaluated in adult male subjects with and without BPH after single and multiple administrations with doses ranging from 0.1 mg to 48 mg per day.
Croatian: Placebo bez BHP nakon jednokratne i višekratnih primjena doza u rasponu od 0,1 mg do 48 mg na dan.
English: Hypotension1
Croatian: palpitacije1
English: If you stop taking Silodosin Recordati
Croatian: Ako prestanete uzimati Silodozin Recordati
English: Alpha-blockers There is inadequate information about the safe use of silodosin in association with other α-adrenoreceptor antagonists.
Croatian: Nema odgovarajućih podataka o sigurnosti primjene silodozina s drugim antagonistima α-adrenergičkih receptora.
English: Libido decreased
Croatian: Psihijatrijski poremećaji smanjeni libido
English: Silodosin Recordati 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
Croatian: Silodozin Recordati 4 mg su žute, neprozirne tvrde želatinske kapsule, veličine 3 (približno 15,9 x 5,8 mm).
English: Silodosin Recordati 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Croatian: Silodozin Recordati 8 mg su bijele, neprozirne, tvrde želatinske kapsule, veličine 0 (približno 21,7 x 7,6 mm).
English: Orthostatic effects
Croatian: Ortostatski učinci
English: Very rare side effects (may affect up to 1 in 10,000 people) • Other allergic reactions with swelling of the face or throat
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) • poremećaj ejakulacije (smanjeno ili neprimjetno oslobađanje sjemena u spolnom odnosu,
English: No dose adjustment is required for patients with mild to moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze kod bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
English: Approximately half of the patients reported an improvement in the most bothersome symptoms complained at baseline by the patients (i.e. nocturia, frequency, decreased stream, urgency, terminal dribbling and incomplete emptying), as assessed by the ICS-male questionnaire.
Croatian: Otprilike polovica bolesnika prijavila je poboljšanje u većini neugodnih simptoma na koje su se žalili na početku (npr. noćno mokrenje, učestalo mokrenje, smanjen mlaz mokraće, hitnost mokrenja,
English: For this purpose Silodosin Recordati 4 mg hard capsules are available.
Croatian: U tu su svrhu dostupne tvrde kapsule Silodozin Recordati od 4 mg.
English: Study Treatment arm
Croatian: Ispitivanje Terapijska skupina
English: Common Uncommon Rare
Croatian: Manje često Rijetko
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).
Croatian: Oštećenje funkcije jetre Budući da nema dostupnih podataka u bolesnika s teškim oštećenjem funkcije jetre, ne preporučuje se primjena silodozina u ovih bolesnika (vidjeti dijelove 4.2 i 5.2).
English: If you forget to take Silodosin Recordati
Croatian: Ako ste zaboravili uzeti Silodozin Recordati
English: Allergictype reactions including facial swelling, swollen tongue and pharyngeal oedema1
Croatian: Poremećaji imunološkog sustava alergijske reakcije uključujući i oticanje lica, oticanje jezika i edem ždrijela1
English: The recommended dose is one capsule of Silodosin Recordati 8 mg daily.
Croatian: Preporučena doza je jedna kapsula lijeka Silodozin Recordati 8 mg na dan.
English: Total score
Croatian: IPSS ukupni rezultat
English: Following oral administration of 14C-labelled silodosin, the recovery of radioactivity after 7 days was approximately 33.5% in urine and 54.9% in faeces.
Croatian: 33,5% radioaktivnosti, a u stolici približno 54,9%.
English: The recommended dose is one capsule of Silodosin Recordati 8 mg per day by oral administration.
Croatian: Preporučena doza je jedna kapsula lijeka Silodozin Recordati od 8 mg na dan primjenom kroz usta.
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki poremećaji ejakulacije,
English: In the active-controlled clinical study conducted in Europe, silodosin 8 mg once daily was shown to be non inferior to tamsulosin 0.4 mg once daily: the adjusted mean difference (95% CI) in the IPSS Total Score between treatments in the per-protocol population was 0.4 (-0.4 to 1.1).
Croatian: 8 mg jedanput na dan nije inferioran tamsulozinu od 0,4 mg jedanput na dan: prilagođena prosječna razlika (95% CI) u ukupnom IPSS rezultatu između terapijskih skupina koje su završile ispitivanje prema planu (engl.
English: If you have moderate kidney problems, your doctor will start Silodosin Recordati with caution and possibly with a lower dose (see section 3 “Dose”).
Croatian: Recordati s oprezom i možda u manjoj dozi (pogledajte dio 3 „Doza“).
English: Pregnancy and breast-feeding Not applicable as silodosin is intended for male patients only.
Croatian: Nije primjenjivo jer je silodozin namijenjen samo za primjenu u muškaraca.
English: In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg once daily, a greater improvement in American Urologic Association (AUA) symptom index score was observed with silodosin 8 mg (-6.8 ± 5.8, n = 90; p = 0.0018) and silodosin 4 mg (-5.7 ± 5.5, n = 88; p = 0.0355) as compared to placebo (-4.0 ± 5.5, n = 83).
Croatian: n = 90; p = 0,0018) i silodozina u dozi od 4 mg (-5,7 ± 5,5, n = 88; p = 0,0355) u odnosu na placebo (-4,0 ± 5,5, n = 83).
English: How to take Silodosin Recordati
Croatian: Kako uzimati Silodozin Recordati
English: Each capsule contains 4 mg of silodosin.
Croatian: Jedna kapsula sadrži 4 mg silodozina.
English: What Silodosin Recordati is and what it is used for
Croatian: Što je Silodozin Recordati i za što se koristi Što je Silodozin Recordati
English: Irritative symptoms
Croatian: IPSS simptomi iritacije
English: In patients with severe renal impairment administration of Silodosin Recordati is not recommended.
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega ne preporučuje se primjena lijeka Silodozin
English: Each capsule contains 8 mg of silodosin.
Croatian: Jedna kapsula sadrži 8 mg silodozina.
English: No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem funkcije bubrega (CLcr ≥ 50 do
English: Via M. Civitali 1
Croatian: Recordati Industria Chimica e Farmaceutica S.p.A. Via M. Civitali 1
English: Accordingly, no dose adjustment is required in patients with mild renal impairment.
Croatian: Sukladno tome, nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem funkcije bubrega.
English: Body clearance of silodosin was approximately 0.28 L/h/kg.
Croatian: 0,28 l/h/kg.
English: Silodosin Recordati 8 mg hard capsules
Croatian: Silodozin Recordati 8 mg tvrde kapsule
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).
Croatian: U placebom kontroliranom ispitivanju s 24 ispitanika u dobi od 45 do 78 godina koji su primali silodozin, istovremena primjena sildenafila od 100 mg ili tadalafila od
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kongestija nosa
English: How to store Silodosin Recordati
Croatian: Kako čuvati Silodozin Recordati
English: In all studies, patients treated with silodosin had a greater decrease in both storage (irritative) and voiding (obstructive) symptoms of BPH as compared to placebo as assessed after 12 weeks of treatment.
Croatian: (iritativnih) i mokrenja (opstruktivnih) u usporedbi s placebom na temelju procjene nakon 12 tjedana liječenja.
English: What Silodosin Recordati is used for
Croatian: Za što se Silodozin Recordati koristi
English: Ejaculatory disorders, including retrograde ejaculation, anejaculation
Croatian: uključujući retrogradn u ejakulaciju izostanak ejakulacije erektilna disfunkcija
English: B e lgië/Belgique/Belgien Recordati Ireland Ltd.
Croatian: België/Belgique/Belgien
English: Patients should be informed about the possible occurrence of symptoms related to postural hypotension (such as dizziness) and should be cautioned about driving or operating machines until they know how silodosin will affect them.
Croatian: (kao što je omaglica) i upozoreni da ne voze i ne rade sa strojevima dok ne vide kako na njih utječe silodozin.
English: INFORMATION IN BRAILLE silodosin recordati 4 mg
Croatian: Silodozin Recordati 4 mg
English: Obstructive symptoms
Croatian: IPSS simptomi opstrukcije
English: Silodosin Recordati 8 mg hard capsules Silodosin Recordati 4 mg hard capsules silodosin
Croatian: Silodozin Recordati 4 mg tvrde kapsule Silodozin Recordati 8 mg tvrde kapsule
English: Lie tuva
Croatian: • suha usta
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava omaglica sinkopa, gubitak svijesti1
English: Ask your doctor whether or not you should postpone or temporarily stop taking Silodosin Recordati when undergoing cataract surgery.
Croatian: Upitajte liječnika trebate li odgoditi ili privremeno prekinuti uzimanje lijeka
English: INFORMATION IN BRAILLE silodosin recordati 8 mg
Croatian: silodozin recordati 8 mg
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Silodosin Recordati 4 mg hard capsules Each hard capsule contains 4 mg silodosin.
Croatian: Silodozin Recordati 4 mg tvrde kapsule Jedna tvrda kapsula sadrži 4 mg silodozina.
English: Very common side effects (may affect more than 1 in 10 people)
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba)
English: NAME OF THE MEDICINAL PRODUCT Silodosin Recordati 4 mg hard capsules silodosin
Croatian: Silodozin Recordati 4 mg tvrde kapsule silodozin
English: Pharmacotherapeutic group: Urologicals, alpha-adrenoreceptor antagonists, ATC code: G04CA04.
Croatian: Farmakoterapijska skupina: Lijekovi koji djeluju na mokraćni sustav, alfa-adrenergičkih receptora,
English: No. of patients
Croatian: Br. Bolesnika
English: NAME OF THE MEDICINAL PRODUCT Silodosin Recordati 8 mg hard capsules silodosin
Croatian: Silodozin Recordati 8 mg tvrde kapsule silodozin
English: Fe rtilty
Croatian: Rok valjanosti
English: Recordati Industria Chimica e Farmaceutica S.p.A. Tel: + 39 02 487871
Croatian: Tel: + 39 02 487871
English: There are also links to other websites about rare diseases and treatments.
Croatian: Postoje također poveznice na druge web stranice o rijetkim bolestima i liječenjima istih.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Molimo Vas obavijestite svog liječnika ili ljekarnika ukoliko uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući lijekove koji se mogu dobiti bez recepta.
English: These symptoms resolved once the dose was reduced.
Croatian: Ovi su simptomi prestali nakon smanjenja doze.
English: Please consult your doctor for advice if you are pregnant or planning to become pregnant.
Croatian: Molimo Vas da se posavjetujete s Vašim liječnikom ukoliko ste trudni ili planirate trudnoću.
English: Read all of this leaflet carefully before you start taking this medicine.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek.
English: Based on clinical experience, the treatment may be started as early as the first day of life.
Croatian: Na temelju kliničkog iskustva, liječenje se smije započeti već prvi dan života.
English: This disorder persists during the entire life of the affected patient and therefore the need for this treatment is lifelong.
Croatian: Ovaj poremećaj traje tijekom čitavog života bolesnika te je stoga potreba za ovim liječenjem doživotna.
English: Their range was consistent with those measured in healthy adults, even in newborn infants.
Croatian: Njen raspon bio je u skladu s onim izmjerenim kod zdravih odraslih osoba, čak i kod novorođenčadi.
English: No specific interaction studies have been performed.
Croatian: Nisu provedena specifična ispitivanja interakcija.
English: Always take Carbaglu exactly as your doctor has instructed you.
Croatian: Uvijek uzimajte Carbaglu točno kako Vam je propisao Vaš liječnik.
English: When the treatment was instituted before any permanent brain damage, patients exhibited normal growth and psychomotor development.
Croatian: Kada se liječenje uvede prije trajnog oštećenja mozga, bolesnici pokazuju normalan rast i psihomotorni razvoj.
English: 36 months After first opening of the tablet container: 3 months
Croatian: 36 mjeseci Nakon prvog otvaranja spremnika s tabletama: 3 mjeseca
English: This leaflet was last approved on
Croatian: Uputa je zadnji puta odobrena u
English: Patients suffering from one of these disorders need treatment during the hyperammonaemia crisis.
Croatian: Bolesnici koji imaju jedan od ovih poremećaja trebaju se liječiti tijekom hiperamonijemične krize.
English: Date of first authorisation: 24 January 2003 Date of renewal: 20 May 2008
Croatian: Datum obnove: 20. svibanj 2008.
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)
Croatian: EU/1/02/246/001 (15 tableta za oralnu suspenziju) EU/1/02/246/002 (60 tableta za oralnu suspenziju) EU/1/02/246/003 (5 tableta za oralnu suspenziju)
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.
Croatian: Radi praćenja Vašeg stanja i liječenja, liječnik može redovito pregledavati Vašu jetru, bubrege, srce te krv.
English: Protein binding has not been determined.
Croatian: Vezanje za proteine nije utvrđeno.
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.
Croatian: Na temelju farmakokinetičkih podataka i kliničkog iskustva preporučuje se podijeliti ukupnu dnevnu dozu na dvije do četiri doze dane prije obroka ili hranjenja.
English: 2.2 Qualitative and quantitative composition For a full list of excipients, see section 6.1
Croatian: 2.2 Kvalitativan i kvantitativan sastav Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
English: The breaking of the tablets in halves allows most of the required posology adjustments.
Croatian: Lomljenje tableta na pola omogućuje većinu potrebnih prilagodbi doziranja.
English: Animal studies have revealed minimal developmental toxicity (see section 5.3).
Croatian: Studije na životinjama pokazale su minimalnu razvojnu toksičnost (vidjeti dio 5.3).
English: Occasionally, the use of quarter tablets may also be useful to adjust the posology prescribed by the physician.
Croatian: Povremeno, primjena četvrtina tableta može također biti korisna da bi se prilagodilo doziranje propisano od strane liječnika.
English: Diffusion into erythrocytes is non existent.
Croatian: Nema difuzije u eritrocite.
English: What Carbaglu is and what it is used for Before you take Carbaglu How to take Carbaglu Possible side effects 5 How to store Carbaglu Further information
Croatian: Što je Carbaglu i za što se koristi Prije nego počnete uzimati Carbaglu Kako uzimati Carbaglu Moguće nuspojave Kako čuvati Carbaglu Dodatne informacije
English: Like all medicines, Carbaglu can have side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, Carbaglu može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: Do not store above 30C.
Croatian: Ne čuvati na temperaturi iznad 30°C.
English: Do not take Carbaglu if you are hypersensitive (allergic) to carglumic acid or any of the other ingredients of Carbaglu.
Croatian: Nemojte uzimati Carbaglu ako ste preosjetljivi (alergični) na karglumatnu kiselinu ili bilo koji drugi sastojak lijeka Carbaglu.
English: Pharmacotherapeutic group: Amino acids and derivatives; ATC code: A16AA05
Croatian: Farmakoterapijska skupina: Aminokiseline i derivati; ATK oznaka: A16AA05
English: If you take more Carbaglu than you should Ask your doctor or pharmacist for advice.
Croatian: Ako uzmete više lijeka Carbaglu nego što ste trebali Pitajte svog liječnika ili ljekarnika za savjet.
English: • Common: increased sweating
Croatian: • Često: pojačano znojenje
English: The tablets are white and elongated with three score marks and engraved on one side.
Croatian: Tablete su bijele i duguljaste s tri zareza i urezane s jedne strane.
English: Other studies have been conducted in rats under different experimental conditions leading to increased ammonia availability (starvation, protein-free or high-protein diet).
Croatian: Druge su studije provedene na štakorima pod različitima eksperimentalnim okolnostima koje dovode do povećane raspoloživosti amonijaka (gladovanje, dijeta bez proteina ili dijeta s visokom razinom proteina).
English: Carbaglu can help eliminating excessive ammonia plasma levels (elevated ammonia level in the blood).
Croatian: Carbaglu može pomoći u uklanjanju prekomjernih razina amonijaka u plazmi (povišene razine amonijaka u krvi).
English: Write the date of opening on the tablet container.
Croatian: Zapišite datum otvaranja na spremnik tableta.
English: The maternal systemic exposures after 500 and 2000 mg/kg/day were twenty five times and seventy times the expected human exposure.
Croatian: Sistemska izloženost ženki nakon 500 i 2000 mg/kg/dan bila je dvadeset pet puta te sedamdeset puta veća od očekivane izloženosti kod ljudi.
English: Caution should be exercised when prescribing to pregnant women.
Croatian: Potreban je oprez prilikom primjene kod trudnica.
English: Whatever the daily dose, they were slowly declining over 15 hours to levels around 100 ng/ml.
Croatian: Bez obzira na dnevnu dozu, ona se polako spuštala kroz 15 sati do razine od oko 100 ng/ml.