FrancophonIA/ELRC3.0 huggingface dataset:
English: *Plus subsequent titrating, see section “Titration and maintenance”
Croatian: * uz naknadnu titraciju, vidjeti dio „Titracija i održavanje”
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: The recommended starting dose of Renvela tablets for adults and elderly is one to two tablets of 800 mg with each meal, 3 times a day.
Croatian: Preporučena početna doza Renvela tableta za odrasle i starije osobe je jedna do dvije tablete od 800 mg uz svaki obrok 3 puta na dan.
English: Renvela must be taken three times per day with meals or snacks.
Croatian: Renvela se mora uzimati tri puta dnevno s obrocima ili međuobrocima.
English: Forty-nine (49) patients received sevelamer carbonate and 51 received placebo during the 2 week FDP.
Croatian: Četrdesetdevet (49) bolesnika primilo je sevelamerkarbonat, a 51 je primio placebo tijekom 2 tjedna razdoblja fiksne doze.
English: Renvela is unlikely to affect your ability to drive or to use machines.
Croatian: Nije vjerojatno da će Renvela utjecati na sposobnost upravljanja vozilima i strojevima.
English: Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures.
Croatian: Povišene razine fosfora u serumu također mogu izazvati svrbež kože, crvenilo očiju te bolove u kostima i prijelome kostiju.
English: Triglycerides, HDL-cholesterol and albumin levels did not change following sevelamer treatment.
Croatian: Razine triglicerida, HDL kolesterola i albumina nisu se promijenile nakon liječenja sevelamerom.
English: If you consider stopping your Renvela treatment, contact your doctor or pharmacist first.
Croatian: Ako razmišljate o prestanku uzimanja lijeka Renvela, obratite se najprije svom liječniku ili ljekarniku.
English: 0.8 g three times daily Titrate up/down by 0.4 g three times daily 1.6 g three times daily Titrate up/down by 0.8 g three times daily
Croatian: 0,8 g tri puta dnevno titrirati na više/niže za 0,4 g tri puta dnevno 1,6 g tri puta dnevno titrirati na više/niže za 0,8 g tri puta dnevno
English: Preparation using a dosing spoon
Croatian: Priprema uporabom dozirne žličice
English: o Close the sachet by folding over twice.
Croatian: o Zatvorite vrećicu dvostrukim preklapanjem.
English: Each bottle contains 30 tablets or 180 tablets.
Croatian: Jedna bočica sadrži 30 tableta ili 180 tableta.
English: Patients receiving dialysis are subject to certain risks for infection specific to dialysis modality.
Croatian: Bolesnici na dijalizi izloženi su određenim rizicima od infekcije specifične za pojedinu vrstu dijalize.
English: **Plus subsequent titrating, see section “Titration and maintenance”
Croatian: ** uz naknadnu titraciju, vidjeti dio „Titracija i održavanje”
English: In the clinical trials in haemodialysis patients, sevelamer alone did not have a consistent and clinically significant effect on iPTH.
Croatian: U kliničkim ispitivanjima u bolesnika na hemodijalizi sevelamer sam nije imao trajan i klinički značajan učinak na iPTH.
English: • being sick frequently
Croatian: • često povraćate
English: Consequently, sevelamer carbonate should not be taken simultaneously with ciprofloxacin.
Croatian: Stoga se sevelamerkarbonat ne bi smio uzimati istodobno s ciprofloksacinom.
English: The effects of sevelamer on phosphorus and calcium were proven to be maintained throughout a study with one year follow-up.
Croatian: Dokazalo se da su učinci na fosfor i kalcij održani tijekom cijelog ispitivanja uz jednogodišnje praćenje nakon ispitivanja.
English: Sevelamer carbonate does not contain any calcium.
Croatian: Sevelamerkarbonat ne sadrži kalcij.
English: Taking your Renvela treatment is important to maintain an appropriate phosphate level in your blood.
Croatian: Uzimanje lijeka Renvela je važno za održavanje odgovarajuće razine fosfata u krvi.
English: Frequency is not known.
Croatian: Učestalost nije poznata.
English: In an in vitro mammalian cytogenetic test with metabolic activation, sevelamer hydrochloride caused a statistically significant increase in the number of structural chromosome aberrations.
Croatian: U in vitro citogenetskom testu s metaboličkom aktivacijom na sisavcima sevelamerklorid je prouzročio statistički značajno povećanje broja strukturnih kromosomskih aberacija.
English: • have disturbed level of bicarbonate in your blood and increased acidity in the blood and other body tissue.
Croatian: • imati poremećene razine bikarbonata u krvi i povećanu kiselost krvi i drugih tjelesnih tkiva.
English: The most frequently occurring (≥ 5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class.
Croatian: Sve najčešće nuspojave (≥ 5% bolesnika) pripadale su među poremećaje probavnog sustava.
English: This information was obtained from studies in which sevelamer hydrochloride was used.
Croatian: Ovi su podaci dobiveni u ispitivanjima u kojima se primjenjivao sevelamerklorid.
English: It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood);
Croatian: Može se koristiti u bolesnika koji su podvrgnuti hemodijalizi (uz pomoć uređaja za filtraciju krvi) ili peritonealnoj dijalizi (kada se tekućina pumpa u trbušnu šupljinu, a unutarnja tjelesna membrana filtrira krv);
English: Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as haemorrhage, perforation, ulceration, necrosis, colitis and colonic/caecal mass) associated with the presence of sevelamer crystals have been reported (see section 4.8).
Croatian: Prijavljeni su slučajevi ozbiljnih upalnih poremećaja različitih dijelova gastrointestinalnog trakta (uključujući ozbiljne komplikacije kao što su hemoragija, perforacija, ulceracija, nekroza, kolitis i masa u crijevima/cekumu) povezani s prisutnošću kristala sevelamera (vidjeti dio 4.8).
English: Sevelamer carbonate is not indicated for the control of hyperparathyroidism.
Croatian: Sevelamerkarbonat nije indiciran za kontrolu hiperparatireoze.
English: Sevelamer does not contain calcium and decreases the incidence of hypercalcaemic episodes as compared to patients using calcium based phosphate binders alone.
Croatian: Sevelamer ne sadrži kalcij te smanjuje incidenciju epizoda hiperkalcijemije u odnosu na bolesnike koji uzimaju samo vezače fosfata na bazi kalcija.
English: Sevelamer has been shown to bind bile acids in vitro and in vivo in experimental animal models.
Croatian: Dokazano je da sevelamer veže žučne kiseline in vitro i in vivo u eksperimentalnim životinjskim modelima.
English: Hypocalcaemia/hypercalcaemia
Croatian: Hipokalcijemija/hiperkalcijemija
English: Patients taking sevelamer carbonate should adhere to their prescribed diets.
Croatian: Bolesnici koji uzimaju sevelamerkarbonat moraju se pridržavati propisane prehrane.
English: This medicine should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Croatian: Ovaj lijek se treba koristiti zajedno s ostalim metodama liječenja poput nadomjestaka kalcija i primjene vitamina D, kako bi se spriječio razvoj bolesti kostiju.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: Ako imate dodatnih pitanja o tome kako se ovaj lijek uzima, pitajte svog liječnika ili ljekarnika.
English: It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood.
Croatian: On veže fosfate iz hrane u probavnom sustavu i na taj način snižava razine serumskog fosfora u krvi.
English: Additional treatments Due to either your kidney condition or your dialysis treatment you may:
Croatian: Dodatna liječenja: Kao posljedicu bubrežne bolesti ili liječenja dijalizom možete:
English: Peritonitis is a known complication in patients receiving peritoneal dialysis and in a clinical trial with sevelamer hydrochloride, a greater number of peritonitis cases were reported in the sevelamer group than in the control group.
Croatian: Peritonitis je poznata komplikacija u bolesnika koji su na peritonealnoj dijalizi, a u kliničkom ispitivanju sevelamerklorida prijavljen je veći broj slučajeva peritonitisa u skupini liječenoj sevelamerkloridom nego u kontrolnoj skupini.
English: Instead of water, the powder may be pre-mixed with a small amount of cold beverage (about 120 ml or half a glass) or food (about 100 grams) and consumed within 30 minutes.
Croatian: Umjesto s vodom, prašak se može prethodno pomiješati s malom količinom hladnog pića (oko 120 ml ili pola čaše) ili hranom (oko 100 grama) i konzumirati unutar 30 minuta.
English: Proton pump inhibitors
Croatian: Inhibitori protonske pumpe
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Croatian: Stopa prijavljivanja definirana je 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: Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse reactions.
Croatian: Sevelamerklorid, koji sadrži istu djelatnu tvar kao sevelamerkarbonat, se davao normalnim, zdravim dobrovoljcima u dozama do 14 grama na dan tijekom osam dana bez nuspojava.
English: As part of good clinical practice, monitoring of serum bicarbonate levels is therefore recommended.
Croatian: Stoga se, u sklopu dobre kliničke prakse, preporučuje pozornije praćenje razina bikarbonata u serumu.
English: Constipation is a very common side effect (may affect more than 1 in 10 people).
Croatian: Zatvor je vrlo česta nuspojava (može se javiti u više od 1 na 10 osoba).
English: It is unknown whether sevelamer/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se sevelamer/metaboliti u majčino mlijeko.
English: Renvela powder for oral suspension is a pale yellow powder supplied in a foil sachet with a heat seal.
Croatian: Renvela prašak za oralnu suspenziju je blijedožuti prašak koji se nalazi u toplinski zalijepljenoj vrećici od folije.
English: • major gastrointestinal tract surgery Treatment of these patients with Renvela should only be initiated after careful benefit/risk assessment.
Croatian: • velikim operativnim zahvatom u gastrointestinalnom traktu Liječenje tih bolesnika lijekom Renvela treba započeti tek nakon pomne procjene koristi i rizika.
English: Uncommon reports of difficulty swallowing the Renvela tablet have been reported.
Croatian: Manje često su prijavljene poteškoće s gutanjem Renvela tableta.
English: Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, is not absorbed from the gastrointestinal tract, as confirmed by an absorption study in healthy volunteers.
Croatian: Sevelamerklorid, koji sadrži istu djelatnu tvar kao sevelamerkarbonat, ne apsorbira se iz gastrointestinalnog trakta, što je potvrđeno ispitivanjem apsorpcije na zdravim dobrovoljcima.
English: 27% of paediatric patients reached their age appropriate serum phosphorus level at end of treatment.
Croatian: Na kraju liječenja 27% pedijatrijskih bolesnika dostiglo je razinu fosfora u serumu prikladnu za dob.
English: Renvela film-coated tablets are white tablets with Renvela 800 imprinted on one side.
Croatian: Renvela filmom obložene tablete su bijele tablete, s otisnutom oznakom Renvela 800 na jednoj strani.
English: It cannot be excluded that sevelamer carbonate can bind fat-soluble vitamins contained in ingested food.
Croatian: Ne može se isključiti mogućnost da sevelamerkarbonat veže vitamine topive u mastima iz konzumirane hrane.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with sevelamer carbonate should be made taking into account the benefit of breast-feeding to the child and the benefit of sevelamer carbonate therapy to the woman.
Croatian: Odluku o tome treba li nastaviti odnosno prekinuti dojenje ili nastaviti odnosno prekinuti liječenje sevelamerkarbonatom treba donijeti uzimajući u obzir dobrobit dojenja za dijete i korist od terapije sevelamerkarbonatom za majku.
English: These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystals deposit in your bowel.
Croatian: Ovi simptomi se mogu javiti zbog ozbiljne upalne bolesti crijeva uzrokovane nakupinama kristala sevelamera u crijevima.
English: Patients who are constipated should be monitored carefully while being treated with Renvela.
Croatian: Bolesnike koji pate od konstipacije treba pomno nadzirati tijekom liječenja lijekom Renvela.
English: Pharmacokinetic studies have not been carried out with sevelamer carbonate.
Croatian: Nisu provedena farmakokinetička ispitivanja sa sevelamerkarbonatom.
English: For paediatric patients with a <1.2 BSA (m2), the oral suspension should be administered, as tablet formulations were not tested in this population and therefore are not appropriate for this population.
Croatian: Pedijatrijskim bolesnicima s površinom tijela <1,2 m treba biti primijenjena oralna suspenzija budući da tablete nisu ispitane u ovoj populaciji i stoga nisu prikladne za ovu populaciju.
English: They will base the dose on your serum phosphorus level.
Croatian: On će odrediti Vašu dozu na temelju razine fosfora u serumu.
English: Powder for oral suspension.
Croatian: OBLIK Prašak za oralnu suspenziju.
English: These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body.
Croatian: Te naslage mogu otvrdnuti krvne žile i otežati cirkulaciju krvi u tijelu.
English: Serum phosphorus level in patients
Croatian: Razina fosfora u serumu bolesnika
English: In some cases where Renvela should be taken at the same time as another medicine, your doctor may advise you to take this medicine 1 hour before or 3 hours after Renvela intake.
Croatian: U slučajevima kada lijek Renvela morate uzimati istodobno s drugim lijekom, liječnik Vam može preporučiti da taj lijek uzmete 1 sat prije ili 3 sata nakon uzimanja lijeka Renvela.
English: Stir the suspension and drink it within 30 minutes of being prepared.
Croatian: Promiješajte suspenziju i popijte ju u roku od 30 minuta od pripreme.
English: Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop Renvela treatment.
Croatian: Obratite se svom liječniku koji će odlučiti možete li dojiti svoje dijete ili ne te da li je potrebno prekinuti liječenje lijekom Renvela.
English: If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental vitamins as necessary.
Croatian: Ako ne uzimate multivitaminske dodatke prehrani, mogu se sniziti vrijednosti vitamina A, E i K te folne kiseline u krvi te će ih stoga liječnik možda pratiti i po potrebi Vam propisati vitaminsku dopunu.
English: The powder may also be pre-mixed with cold beverage or unheated food (see section 4.2).
Croatian: Prašak se također prethodno može pomiješati s hladnim pićem ili hranom koja nije zagrijana (vidjeti dio 4.2).
English: You should tell your doctor immediately if you experience any new signs or symptoms of abdominal distress, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal rigidity, constipation, fever, chills, nausea or vomiting.
Croatian: Odmah obavijestite svog liječnika ako primijetite nove znakove ili simptome nelagode, oticanja ili bolova u trbuhu, osjetljivosti ili tvrdoće trbuha, zatvor, vrućicu, zimicu, mučninu ili povraćanje.
English: Carcinogenicity studies with oral sevelamer hydrochloride were conducted in mice (doses of up to 9 g/kg/day) and rats (0.3, 1, or 3 g/kg/day).
Croatian: Provedena su ispitivanja karcinogenosti uz peroralnu primjenu sevelamerklorida miševima (doze do 9 g/kg/dan) i štakorima (0,3, 1 ili 3 g/kg/dan).
English: • severe gastrointestinal motility disorders including untreated or severe gastroparesis, retention of gastric contents and abnormal or irregular bowel motion
Croatian: • teškim poremećajima motiliteta gastrointestinalnog trakta uključujući i neliječenu ili tešku gastroparezu, retenciju želučanog sadržaja te neuobičajenu ili nepravilnu peristaltiku crijeva
English: Follow the diet prescribed by your doctor.
Croatian: Pridržavajte se dijete koju Vam je propisao Vaš liječnik.
English: Renvela 800 mg
Croatian: 800 mg
English: Contact your doctor who will decide on continuing the treatment or not.
Croatian: Obratite se liječniku koji će odlučiti hoćete li nastaviti s liječenjem ili ne.
English: Adverse reactions that occurred during clinical trials or that were spontaneously reported from postmarketing experience are listed by frequency in the table below.
Croatian: Nuspojave iz kliničkih ispitivanja ili one koje su spontano prijavljene nakon stavljanja lijeka u promet navedene su prema učestalosti u tablici u nastavku.
English: Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become protonated in the stomach.
Croatian: Sevelamer sadrži brojne amine koji su od polimerne okosnice odvojeni jednim ugljikom, a u želucu ti amini vežu na sebe protone.
English: The powder may also be pre-mixed with cold beverage or unheated food (see 4.2).
Croatian: Prašak se također prethodno može pomiješati s hladnim pićem ili hranom koja nije zagrijana (vidjeti 4.2).
English: • have undergone major surgery on your stomach or bowel
Croatian: • imali ste veliku operaciju želuca ili crijeva
English: For paediatric patients the oral suspension should be administered, as tablet formulations are not appropriate for this population.
Croatian: Pedijatrijskim bolesnicima treba biti primijenjena oralna suspenzija budući da tablete nisu prikladne za ovu populaciju.
English: The white to off-white tablets are imprinted with “RENVELA 800” on one side.
Croatian: Bijele do bjelkaste tablete na jednoj strani imaju otisnutu oznaku „RENVELA 800”.
English: By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer lowers the phosphorus concentration in the serum.
Croatian: Vezujući fosfate u gastrointestinalnom traktu i smanjujući njihovu apsorpciju, sevelamer snižava koncentraciju fosfora u serumu.
English: These protonated amines bind negatively charged ions such as dietary phosphate in the intestine.
Croatian: Protonirani amini u crijevima vežu negativno nabijene ione, kao što su fosfati iz hrane.
English: In rats and dogs, sevelamer reduced absorption of fat soluble vitamins D, E and K (coagulation factors), and folic acid.
Croatian: U štakora i pasa sevelamer je smanjio apsorpciju vitamina topivih u mastima - vitamina D, E i K (faktora koagulacije) i folne kiseline.
English: • Hypophosphataemia
Croatian: • Hipofosfatemija
English: For doses of less than 0.8 g, the powder in the sachet may be divided.
Croatian: Za doze manje od 0,8 g, prašak u vrećici može se podijeliti.
English: When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after sevelamer carbonate, or the physician should consider monitoring blood levels.
Croatian: Prilikom primjene bilo kojeg lijeka, čija bi smanjena bioraspoloživost mogla imati klinički značajan učinak na sigurnost ili djelotvornost, taj se lijek mora primijeniti najmanje jedan sat prije ili tri sata nakon sevelamerkarbonata ili liječnik mora razmotriti praćenje razina u krvi.
English: Total daily dose of sevelamer carbonate to be taken over 3 meals/snacks per day
Croatian: Ukupna dnevna doza sevelamerkarbonata koju treba uzimati raspoređenu na 3 dnevna obroka/međuobroka
English: o Do not tap the dosing spoon to compact the powder.
Croatian: o Ne tapkajte žličicu za doziranje kako biste stisnuli prašak.
English: Patients with CKD are predisposed to developing metabolic acidosis.
Croatian: Bolesnici s kroničnom bubrežnom bolešću imaju predispoziciju za razvoj metaboličke acidoze.
English: • active inflammatory bowel disease
Croatian: • aktivnom upalnom bolešću crijeva
English: If you forget to take Renvela
Croatian: Ako ste zaboravili uzeti lijek Renvela
English: For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Renvela should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Croatian: Bolesnicima koji su prethodno uzimali vezače fosfata (sevelamerklorid ili vezače fosfata na bazi kalcija) Renvela se mora davati gram za gram, uz praćenje razina fosfora u serumu kako bi se osigurala primjena optimalnih dnevnih doza.
English: Total daily dose of sevelamer carbonate to be taken over 3 meals per day
Croatian: Ukupna dnevna doza sevelamerkarbonata koju treba uzeti raspoređenu na 3 dnevna obroka
English: Patients with CKD may develop hypocalcaemia or hypercalcaemia.
Croatian: U bolesnika s kroničnom bubrežnom bolešću može se razviti hipokalcijemija ili hiperkalcijemija.
English: Stopping Renvela would lead to important consequences such as calcification in the blood vessels.
Croatian: Prestanak uzimanja lijeka Renvela dovest će do ozbiljnih posljedica kao što su otvrdnuće krvih žila.
English: Inflammatory gastrointestinal disorders
Croatian: Upalni gastrointestinalni poremećaji
English: Dialysis Interaction studies have not been conducted in patients on dialysis.
Croatian: Dijaliza Nisu provedena ispitivanja interakcija u bolesnika na dijalizi.
English: 1 See inflammatory gastrointestinal disorders warning in section 4.4
Croatian: *iskustvo nakon stavljanja lijeka u promet Vidjeti upozorenje o gastrointestinalnim upalnim poremećajima u dijelu 4.4
English: Many of these cases involved patients with co-morbid conditions including swallowing disorders or oesophageal abnormalities.
Croatian: Mnogi od tih slučajeva odnosili su se na bolesnike s popratnim bolestima, uključujući poremećaje gutanja i anomalije jednjaka.
English: Other side effects have been reported in patients taking Renvela:
Croatian: Ostale nuspojave prijavljene u bolesnika koji su uzimali lijek Renvela:
English: This is a very rare side effect (may affect up to 1 in 10,000 people).
Croatian: Ovo je vrlo rijetka nuspojava (može se javiti u manje od 1 na 10 000 osoba).
English: Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Croatian: Renvela je indicirana za kontrolu hiperfosfatemije u odraslih bolesnika koji su na hemodijalizi ili peritonealnoj dijalizi.
English: Your doctor may also consider monitoring the levels of that medicine in your blood.
Croatian: Liječnik također može razmotriti praćenje razina tog lijeka u krvi.
English: In CKD patients, the maximum average daily dose studied was 14.4 grams of sevelamer carbonate in a single daily dose.
Croatian: U bolesnika s kroničnom bubrežnom bolešću najviša prosječna ispitivana dnevna doza iznosila je 14,4 grama sevelamerkarbonata u jednoj dnevnoj dozi.
English: Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and they may adjust the dose of Renvela when necessary to reach an adequate phosphate level.
Croatian: Na početku liječenja, liječnik će Vam svaka 2-4 tjedna provjeravati razine fosfora u krvi te, bude li potrebno, može prilagoditi dozu lijeka Renvela kako bi se postigle odgovarajuće razine fosfata.
English: (Instructions for presentation WITHOUT dosing spoon)
Croatian: (Upute za pakiranje BEZ dozirne žličice)