FrancophonIA/ELRC3.0 huggingface dataset:
English: Titanium dioxide (E171) Erythrosine (E127) Indigotine (E132)
Croatian: Titanijev dioksid (E171) 6.2 Inkompatibilnosti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/007-9
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/367/007-9
English: What you need to know before your child takes Diacomit
Croatian: Što morate znati prije nego
English: Tutti frutti flavour (contains sorbitol) Carmellose sodium Hydroxyethylcellulose
Croatian: Tutti frutti okus (sadrži sorbitol)
English: • If your child takes medicines metabolized by certain liver enzymes: - citalopram (used in the treatment of depressive episodes), - omeprazole (used in case of gastric ulcer) - HIV protease inhibitors (used in the treatment of HIV) - astemizole, chlorpheniramine (antihistamines) - calcium channel blockers (used in the treatment of anger or troubles of heart rhythm), - oral contraceptives, - propranolol, carvedilol, timolol (used in the treatment of high blood pressure), - fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants), - haloperidol (antipsychotics), - codeine, dextromethorphan, tramadol (used in the treatment of pain)
Croatian: - blokatori kalcijskih kanala (koriste se u liječenju boli u prsnom košu ili poremećaja srčanog ritma), - oralna kontracepcijska sredstva, - propranolol, karvedilol, timolol (koriste se u liječenju visokog krvnog tlaka), - fluoksetin, paroksetin, sertralin, imipramin, klomipramin (antidepresivi), - haloperidol (antipsihotici), - kodein, dekstrometorfan, tramadol (koriste se u liječenju boli)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/004-6
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/367/004-6
English: EU/1/06/367/006 90 hard capsules
Croatian: EU/1/06/367/006 90 tvrdih kapsula
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/367/001-3
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/367/001-3
English: 6.5 Nature and contents of container Polypropylene bottle with tamper-evident seal and polyethylene screw cap.
Croatian: 6.5 Vrsta i sadržaj spremnika Vrećice su napravljene od filma sastava papir/aluminij/polietilen.
English: EU/1/06/367/003 90 hard capsules
Croatian: EU/1/06/367/003 90 tvrdih kapsula
English: NAME OF THE MEDICINAL PRODUCT Diacomit 500 mg powder for oral suspension in sachet stiripentol
Croatian: Diacomit 500 mg prašak za oralnu suspenziju u vrećici stiripentol
English: - Clobazam
Croatian: - Klobazam
English: For food and drinks to be avoided, see the section “Diacomit with food and drink” above.
Croatian: U ranijem dijelu „Diacomit s hranom i pićem“ navedeni su hrana i piće koje treba izbjegavati prilikom uzimanja lijeka.
English: Annex I List of medicinal products affected by the procedure
Croatian: Prilog I Popis lijekova podvrgnuti postupku
English: Do not take more than 3 sachets per day.
Croatian: Ne uzimajte više od 3 vrećice na dan.
English: • Make your child eat it straight away.
Croatian: • Dajte djetetu da odmah pojede.
English: Results from literature suggest the following:
Croatian: Rezultati dostupni u literaturi upućuju na sljedeće:
English: Date of first authorisation: 07 April 2014.
Croatian: Datum prvog odobrenja: 07. travnja 2014.
English: Date of latest renewal: 18 December 2018.
Croatian: Datum posljednje obnove odobrenja: 18. prosinca 2018.
English: • Drink straight away
Croatian: Odmah popijte.
English: Treatment should be stopped immediately in this case.
Croatian: U ovom slučaju liječenje se mora odmah prekinuti.
English: • You may notice granules appearing in your stools; this is normal.
Croatian: • Granule možete primijetiti u stolici; to je normalno.
English: Other malformations were observed; however, the exact nature of these findings is unknown.
Croatian: Uočene su i druge malformacije, no, točna priroda ovih rezultata nije poznata.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako je rekao Vaš liječnik.
English: Take the correct amount as prescribed by your doctor.
Croatian: Uzmite ispravnu količinu koju je propisao Vaš liječnik.
English: It is unknown whether it passes through the placental barrier.
Croatian: Nije poznato prolazi li kroz placentalnu barijeru.
English: Reactions are rare after a total dosage of 1.5 g.
Croatian: Reakcije su rijetke nakon ukupne doze od 1,5 g.
English: Studies in animals have shown some reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: 4 g (one sachet) three times per day.
Croatian: 4 g (jedna vrećica) tri puta dnevno.
English: • if you are infected with HIV
Croatian: • ako ste zaraženi HIV-om
English: Wait until the next dose is due, then take your normal dose.
Croatian: Pričekajte do sljedeće doze, te zatim uzmite uobičajenu dozu.
English: Use in infants, children and adolescents
Croatian: Primjena u djece i adolescenata
English: • nerve damage in the hands and feet,
Croatian: • oštećenje živca u dlanovima i stopalima,
English: GRANUPAS can be taken with food.
Croatian: GRANUPAS se može uzimati s hranom.
English: Limited pharmacokinetic data suggest no substantial difference between adults and children.
Croatian: Ograničeni farmakokinetički podaci ukazuju da nema značajne razlike između odraslih osoba i djece.
English: This daily amount is divided into two doses spread out through the day.
Croatian: Ova dnevna količina podijeljena je u dvije doze raspoređene tijekom dana.
English: Not known side effects (frequency cannot be estimated from the available data): • Hepatitis.
Croatian: Nepoznato nuspojave (ne može se procijeniti iz dostupnih podataka): • hepatitis
English: Other medicines and GRANUPAS
Croatian: Drugi lijekovi i GRANUPAS
English: Treatment is usually given for two years (24 months).
Croatian: Uobičajeno trajanje liječenja je dvije godine (24 mjeseca).
English: What GRANUPAS is and what it is used for
Croatian: Što je GRANUPAS i za što se koristi
English: Together they constitute more than 90% of the total metabolites of PAS found in urine.
Croatian: Zajedno oni čine više od 90% ukupnih metabolita PAS-a prisutnih u urinu.
English: If a mild temperature rise or skin reaction develops, the increment is to be dropped back one level or the progression held for one cycle.
Croatian: Ukoliko nastupi blagi porast temperature ili se razvije kožna reakcija, postupno povećanje se mora smanjiti korak unazad za jednu razinu ili se progresija mora obustaviti za jedan ciklus povećanja.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: U obzir se trebaju uzeti i službene smjernice o odgovarajućoj primjeni antibakterijskih lijekova.
English: Most frequent adverse reactions were related to the gastrointestinal system.
Croatian: Najčešće nuspojave povezane su s gastrointestinalnim sustavom.
English: The acetylation process is not genetically determined as is the case for isoniazid.
Croatian: Proces acetilacije nije genetički utvrđen kao što je to u slučaju izoniazida.
English: The recommended schedule is 4 g every 8 hours.
Croatian: Preporučena doza je 4 g svakih 8 sati.
English: If you forget to take a dose of GRANUPAS
Croatian: Ako ste zaboravili uzeti dozu lijeka GRANUPAS
English: Regular monitoring of the thyroid function is indicated for all people living with HIV.
Croatian: Redovito praćenje funkcije štitnjače indicirano je za sve osobe koje imaju HIV.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA
English: The optimal dose regimen in children is uncertain.
Croatian: Optimalni dozni režim u djece je promjenljiv.
English: In a single dose (4 grams) pharmacokinetic study in healthy adult volunteers (N=11) the initial time to a 2 µg/mL serum level of aminosalicylic acid was 2 hours with a range of 45 minutes to 24 hours; the median time to peak was 6 hours with a range of 1.5 to 24 hours; the mean peak level was 20 µg/mL with a range of 9 to 35µg/mL: a level of 2 µg/mL was maintained for an average of 8 hours with a range of 5 to 9.5 a level of 1 µg/mL was maintained for an average of 8.8 hours with a range of 6 to 11.5 hours.
Croatian: U farmakokinetičkom ispitivanju jedne doze (4 grama) u zdravih odraslih dobrovoljaca (N=11), početno vrijeme za postizanje 2 µg/mL razine aminosalicilatne kiseline u serumu bilo je 2 sata s rasponom od 45 minuta do 24 sata; medijan do postizanja vršne koncentracije bio je 6 sati s rasponom od 1,5 do 24 sata; srednja vrijednost vršne koncentracije iznosila je 20 µg/mL s rasponom od 9 do 35µg/mL: razina od 2µg/mL održana je prosječno 8 sati s rasponom od 5 do 9,5 sati, razina od 1 µg/mL održana je prosječno 8,8 sati s rasponom od 6 do 11,5 sati.
English: The dosage is doubled every 2 days until reaching a total of 1 gram after which the dosage is divided to follow the regular schedule of administration.
Croatian: Doza se zatim udvostručuje svaka 2 dana sve dok se ne postigne ukupna doza od 1 grama, nakon čega se doza treba podijeliti kako bi se pratio redoviti raspored primjene.
English: The recommended total dose per day is 150 mg for each kg of body weight.
Croatian: Preporučena ukupna doza na dan iznosi 150 mg po kilogramu tjelesne mase.
English: See section 4.2 for posology adjustments for desensitization.
Croatian: Vidjeti dio 4.2 o prilagodbi doziranja za potrebe desenzibilizacije.
English: • elevated liver enzymes,
Croatian: • povišene vrijednosti jetrenih enzima,
English: Triglyceride absorption is always normal.
Croatian: Apsorpcija triglicerida je uvijek očuvana.
English: • Diphenylhydramine (for allergic reactions)
Croatian: difenilhidramin (za alergijske reakcije)
English: What GRANUPAS is and what it is used for What you need to know before you take GRANUPAS How to take GRANUPAS
Croatian: Što je GRANUPAS i za što se koristi Što morate znati prije nego počnete uzimati GRANUPAS Kako uzimati GRANUPAS
English: Use of GRANUPAS is not recommended in newborn babies (under 28 days of age).
Croatian: Djeca Primjena lijeka GRANUPAS ne preporučuje se u novorođenčadi (mlađe od 28 dana).
English: • reduced ability to absorb nutrients from food ulcer,
Croatian: • smanjena sposobnost apsorpcije hranjivih tvari iz hrane,
English: • To measure the dose: o Lines on the spoon indicate the amount (in milligrams of para-aminosalicylic acid).
Croatian: • Za mjerenje doze: o Linije na žlici označavaju količinu (u miligramima paraaminosalicilatne kiseline).
English: Plasma protein binding is about 50 to 60%, the kinetic distribution has a half-life of 0.94 hours and a volume of distribution of 1.001 L/kg.
Croatian: Vezanje za proteine plazme je 50 do 60%, kinetička distribucija ima poluvijek od 0,94 sati i volumen distribucije od 1,001 L/kg.
English: • red spots on the skin,
Croatian: • crvene mrlje na koži,
English: What GRANUPAS looks like and contents of the pack
Croatian: Kako GRANUPAS izgleda i sadržaj pakiranja
English: Uncommon side effects (may affect more than 1 in 1,000 people): • loss of appetite (anorexia).
Croatian: Manje česte (mogu se pojaviti u više od 1 na 1 000 osoba): • gubitak apetita (anoreksija)
English: • reduction of the ability of red blood cells to release oxygen
Croatian: • smanjenje sposobnosti crvenih krvnih stanica da otpuštaju kisik
English: For infants, children and adolescents the dosage will be adapted to the patient's weight at 150 mg/kg per day, divided in two intakes.
Croatian: Za dojenčad, djecu i adolescente, doza se treba prilagoditi prema tjelesnoj težini bolesnika, i to 150 mg/kg na dan, podijeljeno u dvije dnevne doze.
English: There is no experience with overdose in humans.
Croatian: Nema slučajeva predoziranja u ljudi.
English: Swallow the granules whole.
Croatian: Progutajte cijele granule.
English: The recommended dose for adults is 1 sachet three times a day, with a schedule of 1 sachet every 8 hours.
Croatian: Preporučena doza za odrasle osobe je 1 vrećica tri puta na dan, i to 1 vrećica svakih 8 sati.
English: Lucane Pharma 172 rue de Charonne 75011 Paris France
Croatian: Proizvođač Lucane Pharma 172 rue de Charonne 75011 Paris Francuska
English: Pharmacotherapeutic group: Antimycobacterials, drugs for treatment of tuberculosis, ATC code: J04AA01
Croatian: Farmakoterapijska skupina: Antimikobakterijski lijekovi, lijekovi za liječenje tuberkuloze, ATK oznaka: J04AA01
English: Your physician may need to start with a lower dose to prevent possible side effects.
Croatian: Vaš liječnik će možda i započeti liječenje s manjom dozom kako bi se spriječile nuspojave.
English: • crystals in urine.
Croatian: • kristali u mokraći.
English: The data available from a rat embryofoetal development study, where animals were given sodium aminosalicylate (3.85 to 385 mg/kg) were limited.
Croatian: Podaci dostupni iz ispitivanja embrio-fetalnog razvoja u štakora, u kojima je životinjama davan natrijev aminosalicilat (3,85 do 385 mg/kg), bili su ograničeni.
English: • if you are allergic to para-aminosalicylic acid or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na paraaminosalicilatnu kiselinu ili neku pomoćnu tvar ovog lijeka (navedenu u dijelu 6).
English: GRANUPAS is not recommended during pregnancy and should only be used if advised by your physician.
Croatian: GRANUPAS se ne preporučuje tijekom trudnoće i smije se uzimati samo ako vam je to savjetovao liječnik.
English: The patient must be monitored carefully during the first three months of therapy and treatment must be discontinued immediately at the first sign of a rash, fever or other premonitory signs of intolerance.
Croatian: Bolesnici se moraju pažljivo pratiti tijekom prva tri mjeseca terapije, a liječenje se mora odmah prekinuti na prvi znak osipa, vrućice ili ostalih najavljujućih simptoma netolerancije.
English: • disturbance of gait and equilibrium.
Croatian: • poremećaji hoda i ravnoteže.
English: • yellowing of skin or eyes (jaundice),
Croatian: • žutilo kože ili očiju (žutica),
English: GRANUPAS is unlikely to affect your ability to drive any vehicle and use machines.
Croatian: Nije izgledno da GRANUPAS utječe na Vašu sposobnost upravljanja vozilima i strojevima.
English: The medicinal product should be swallowed immediately after mixing with orange juice, tomato juice, apple sauce and yogurt whilst the granules are intact.
Croatian: Lijek se treba progutati odmah nakon miješanja sa sokom od naranče, sokom od rajčice, kašicom od jabuke ili jogurtom dok su granule još uvijek cijele.
English: • weight loss.
Croatian: • gubitak tjelesne težine.
English: If you experience any of these symptoms, you must contact to your doctor immediately.
Croatian: Ako primijetite bilo koji od navedenih simptoma, morate se odmah obratiti svom liječniku.
English: 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).
Croatian: Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The dose in infants, children and adolescents will be calculated by your doctor based on the patient's body weight.
Croatian: Liječnik će izračunati dozu za dojenčad, djecu i adolescente na temelju tjelesne težine bolesnika.
English: • If some granules are left in the glass, add some more juice and drink straight away.
Croatian: Ako granule ostanu na dnu čaše, dodajte još malo soka i odmah popijte.
English: It should be drunk at once ensuring that the granules are not left in the glass.
Croatian: Sadržaj čaše treba popiti odjednom pazeći da granule nisu ostale u čaši.
English: A dosing spoon is provided to measure small doses below 4 g for young children.
Croatian: S lijekom se isporučuje i žlica za doziranje kako bi se omogućilo mjerenje doza manjih od 4g za mlađu djecu.
English: Cutaneous hypersensitivity reactions were also frequent as well as adverse reactions related to the nervous system.
Croatian: Kožne reakcije preosjetljivosti također su česte kao i nuspojave povezane sa živčanim sustavom.
English: Talk to your doctor or pharmacist before taking GRANUPAS
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete GRANUPAS
English: Results indicate that para-aminosalicylic acid was considered not to have produced any clastogenic effect in mice treated at non-toxic dose levels (examined 24 hours after 2 daily administrations of 312.5 to 1250 mg/kg).
Croatian: Rezultati pokazuju da se paraaminosalicilatna kiselina ne smatra uzrokom bilo kojeg klastogenog učinka u miševa koji su bili tretirani netoksičnim dozama (ispitivani u trajanju od 24 sata nakon 2 dana primjene od 312,5 do 1250 mg/kg).
English: o Put granules directly into the spoon.
Croatian: o Stavite granule izravno na žlicu.
English: 1244 RL Ankeveen The Netherlands
Croatian: 1244 RL Ankeveen Nizozemska
English: It is important that you do not dissolve, crush or chew the granules as they may not absorb properly and may cause stomach ache or bleeding.
Croatian: Važno je da ne otapate, ne drobite i ne žvačete granule jer to može dovesti do slabe apsorcije i uzrokovati bol u želucu ili krvarenje.
English: It inhibits the onset of bacterial resistance to streptomycin and isoniazid.
Croatian: Inhibira razvoj bakterijske rezistencije na streptomicin i izoniazid.
English: Pleural or synovial fluid concentrations are approximately equal to plasma.
Croatian: Koncentracije u pleuralnoj ili sinovijskoj tekućine otprilike su jednake onima u plazmi.
English: Aminosalicylic acid is bacteriostatic against Mycobacterium tuberculosis.
Croatian: Aminosalicilatna kiselina je bakteriostatik protiv Mycobacterium tuberculosis.
English: Each box contains 30 sachets.
Croatian: Jedna kutija sadrži 30 vrećica.
English: The drug does not cross the blood brain barrier in patients unless the meninges are inflamed, when the concentration of para-aminosalicylic acid in cerebrospinal fluid is about 10 to 50% of the plasma.
Croatian: Lijek ne prolazi kroz krvno-moždanu barijeru u bolesnika, osim ako moždana ovojnica nije upaljena, kada koncentracija paraaminosalicilatne kiseline u cerebrospinalnoj tekućini iznosi otprilike 10 do 50% plazmatske koncentracije.
English: Cellulose, microcrystalline
Croatian: Celuloza, mikrokristalična
English: • if you have liver problems or mild or moderate kidney disease
Croatian: • ako imate problema s jetrom ili blagu ili umjerenu bolest bubrega
English: Bone defects were observed at 77 mg/kg only.and increased foetal weight was noted at the other doses.
Croatian: Defekti kostiju uočeni su samo pri 77 mg/kg, a povećana težina fetusa uočena je pri višim dozama.
English: • if you have a stomach ulcer
Croatian: • ako imate čir želuca
English: • soft stools,
Croatian: • mekane stolice,
English: The lack of a dose-response relationship suggests that the findings are not of clinical relevance, but it is noted that the findings were observed at doses below those proposed clinically.
Croatian: Nedostatak odnosa doze i odgovora ukazuje da navedeni rezultati nisu klinički značajni, no isti su uočeni pri dozama manjima od klinički predloženih doza.
English: The cumulative excretion of para-aminosalicylic after 24 hours is 84% of an oral dose of 4 g, 21% as para-aminosalicylic acid and 63% as the acetylated form.
Croatian: Kumulativno izlučivanje paraaminosalicilatne kiseline nakon 24 sata iznosi 84% oralne doze od 4 g, i to 21% u obliku paraaminosalicilatatne kiseline i 63% u acetiliranom obliku.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima..
English: As there are no adequate and well controlled studies of para- aminosalicylic acid in humans, para-aminosalicylic acid should be given to a pregnant woman only if clearly needed.
Croatian: Budući da ne postoje primjerena i dobro kontrolirana ispitivanja paraaminosalicilatne kiseline u ljudi, paraaminosalicilatna kiselina se smije primjenjivati u trudnica samo ako je to neophodno.
English: During the first 3 months of your treatment with GRANUPAS, you must be attentive to any sign of allergic reaction (for example skin eruption, itchy red spots on the skin, itching, rash, watery or itchy eyes or stuffy nose) or hepatitis (for example fever, fatigue, dark urine, pale stool, abdominal pain, yellow skin and eyes).
Croatian: Tijekom prva 3 mjeseca liječenja lijekom GRANUPAS morate obratiti pozornost na bilo kakve znakove alergijske reakcije (poput izbijanja kožnih promjena, crvenih mrlja na koži koje svrbe, svrbeža, osipa, suzenja očiju ili svrbeža u očima te začepljenog nosa) ili hepatitisa (poput vrućice, umora, tamnog urina, svijetle stolice, boli u trbuhu, žute kože i očiju).
English: The first symptoms usually appear within three months of the start of therapy with a rash as the most common adverse reaction followed by fever and much less frequently by gastrointestinal disturbances of anorexia, nausea or diarrhoea.
Croatian: Prvi se simptomi najčešće pojavljuju unutar tri mjeseca od početka terapije, i to kao osip koji je najčešća nuspojava zatim vrućica i mnogo rjeđe gastrointestinalni poremećaji anoreksija, mučnina ili proljev.
English: Gastro-resistant granules The granules are small off white/ light brown coloured approximately 1.5 mm diameter.
Croatian: Granule su male prljavo bijele / svjetlo smeđe boje promjera otprilike 1,5 mm.
English: They will not dissolve, but swirling the juice in the glass will help re-suspend the granules if they sink.
Croatian: Granule se neće otopiti, no miješanjem soka u čaši, granule će se ponovno podići s dna čaše, ukoliko potonu.
English: Decreased prothrombine level, hepatocytolysis.
Croatian: Snižena razina protrombina, hepatocitoliza.
English: Smaller doses in children should be measured using the dosing spoon and given by sprinkling on apple sauce or yogurt.
Croatian: Manje doze u djece trebaju se izmjeriti žlicom za doziranje i dati posipane na kašicu od jabuke ili jogurt.
English: The concentration of the metabolite may be increased in cases of renal failure.
Croatian: Koncentracija metabolita može se povisiti u slučaju zatajenja bubrega.
English: Sodium aminosalicylic acid was not mutagenic in Ames test strain TA 100.
Croatian: Natrij aminosalicilatna kiselina nije bila mutagena u Ames testu soja TA 100.
English: If you are not sure, talk to your doctor or pharmacist before taking GRANUPAS.
Croatian: Ako niste sigurni obratite se svom liječniku ili ljekarniku prije uzimanja lijeka GRANUPAS.
English: In the event of overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse reactions and that appropriate symptomatic treatment is instituted immediately.
Croatian: U slučaju predoziranja preporučuje se praćenje znakova i simptoma nuspojava u bolesnika i trenutno započinjanje simptomatskog liječenja.
English: Given that the metabolites of para-aminosalicylic acid are largely excreted via glomerular filtration, caution is warranted in patients with mild to moderate renal impairment (see also section 4.3).
Croatian: Budući da se metaboliti paraaminosalicilatne kiseline uvelike izlučuju putem glomerularne filtracije, lijek se treba primjenjivati oprezno u bolesnika s blagim do umjerenim oštećenjem bubrega (vidjeti također dio 4.3).
English: The sachets can be stored below 25°C up to 24 hours after first opening.
Croatian: Vrećice se mogu čuvati pri temperaturama do 25°C do 24 sata nakon prvog otvaranja.
English: Patients should be advised that the skeletons of the granules may be seen in the stools.
Croatian: Bolesnike treba upozoriti da se čestice granula mogu uočiti u stolici.
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Croatian: Očekuju se ista učestalost, tip i težina nuspojava u djece kao i u odraslih osoba.