FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with Vfend, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Vfend, potražite u uputi o lijeku.
English: • St John's wort (a herbal preparation used to treat depression);
Croatian: • Gosipna trava (biljni pripravak koji se koristi za liječenje depresije);
English: • cisapride (used for stomach problems);
Croatian: • kisaprid (koristi se protiv želučanih problema);
English: • carbamazepine (used to treat seizures [fits]);
Croatian: • karbamazepin (koristi se za liječenje napadaja);
English: This leaflet was last revised in Other sources of information
Croatian: Ova uputa je zadnji put revidirana u Ostali izvori informacija
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity.
Croatian: Neklinički podaci nisu otkrili poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza ili genotoksičnosti.
English: Most of adverse reactions reported were gastrointestinal in nature.
Croatian: Većina prijavljenih nuspojava bila je gastrointestinalne prirode.
English: Special note for patients on peritoneal dialysis:
Croatian: Posebna napomena za pacijente na peritonejskoj dijalizi:
English: Contact your doctor who will decide on continuing the treatment or not.
Croatian: Javite se svome liječniku koji će odlučiti hoćete li nastaviti s liječenjem ili ne.
English: Not known (frequency cannot be estimated from the available data):
Croatian: Nepoznata učestalost (učestalost se ne može procijeniti iz dostupnih podataka):
English: • if you have low levels of phosphate in your blood (your doctor will check this for you)
Croatian: • ako imate niske razine fosfata u krvi (liječnik će to provjeriti)
English: o Ensure the dosing spoon is dry.
Croatian: o Budite sigurni da je dozirna žličica suha.
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),
English: • if you are allergic to sevelamer carbonate or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na djelatnu tvar ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: o Discard sachets of powder that have been opened for more than 24 hours.
Croatian: o Bacite vrećice praška koje su otvorene više od 24 sata.
English: 1 See inflammatory gastrointestinal disorders warning in section 4.4
Croatian: 1Vidjeti upozorenje o gastrointestinalnim upalnim poremećajima u dijelu 4.4
English: Sevelamer has also been shown to reduce the absorption of several vitamins including folic acid (see sections 4.4 and 5.3).
Croatian: Također se pokazalo da sevelamer smanjuje apsorpciju nekoliko vitamina, uključujući i folatnu kiselinu (vidjeti dijelove 4.4 i 5.3).
English: In a clinical trial of one year, no evidence of accumulation of sevelamer was seen.
Croatian: U jednogodišnjem kliničkom ispitivanju nisu uočeni znakovi akumulacije sevelamera.
English: The symptoms observed in case of overdose are similar to adverse reactions listed in section 4.8, including mainly constipation and other known gastrointestinal disorders.
Croatian: Simptomi koji su primijećeni u slučaju predoziranja slični su nuspojavama navedenima u dijelu 4.8 te uglavnom uključuju konstipaciju i druge poznate gastrointestinalne poremećaje.
English: Genzyme Ireland Limited IDA Industrial Park Old Kilmeaden Road Waterford
Croatian: IDA Industrial Park Old Kilmeaden Road Waterford
English: Sevelamer carbonate Winthrop should be taken with food and not on an empty stomach.
Croatian: Sevelamer carbonate Winthrop se treba uzimati s hranom, a ne na prazan želudac.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: If you get any of the following side effects, seek immediate medical attention: - Allergic reaction (signs including rash, hives, swelling, trouble breathing).
Croatian: Ako razvijete jednu od sljedećih nuspojava, odmah potražite hitnu medicinsku pomoć: - alergijske reakcije (znakovi uključuju osip, koprivnjaču, oticanje i poteškoće s disanjem).
English: Patients on peritoneal dialysis should be closely monitored to ensure the correct use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.
Croatian: Stoga je potrebno pomno nadzirati bolesnike na peritonejskoj dijalizi kako bi se osigurala ispravna primjena odgovarajuće aseptičke tehnike te brzo prepoznali i liječili svi znakovi i simptomi povezani s peritonitisom.
English: Sevelamer carbonate should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus.
Croatian: Sevelamerkarbonat se smije davati trudnicama samo ako je to prijeko potrebno i nakon pažljive analize omjera koristi i rizika, kako za majku tako i za fetus.
English: Animal studies have shown some reproductive toxicity when sevelamer was administered to rats at high doses (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su izvjestan stupanj reproduktivne toksičnosti kada je sevelamer primijenjen štakorima u visokim dozama (vidjeti dio 5.3).
English: <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Tell your doctor if you are taking or have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Sevelamer carbonate Winthrop.
Croatian: • Ako uzimate lijekove za liječenje tegoba sa srčanim ritmom ili epilepsije, morate se posavjetovati sa svojim liječnikom kad uzimate Sevelamer carbonate Winthrop.
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: The recommended starting dose of Sevelamer carbonate Winthrop for children is based on their height and weight (used to calculate body surface area by your physician).
Croatian: Preporučena početna doza lijeka Sevelamer carbonate Winthrop za djecu temelji se na njihovoj visini i težini (koje liječnik koristi za izračunavanje površine tijela).
English: Do not give this medicine to children below the age of 6 years because the safety and efficacy in children (below the age of 6 years) have not been studied.
Croatian: Ovaj lijek se ne smije primjeniti kod djece mlađe od 6 godina jer sigurnost i djelotvornost u djece (mlađe od 6 godina) nisu ispitivane.
English: *Plus subsequent titrating, see section “Titration and maintenance”
Croatian: *uz naknadnu titraciju, vidjeti dio „Titracija i održavanje”
English: You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
Croatian: Kod Vas se može razviti peritonitis (infekcija tekućine u trbuhu) povezan s peritonejskom dijalizom.
English: **Plus subsequent titrating, see section “Titration and maintenance”
Croatian: **uz naknadnu titraciju, vidjeti dio „Titracija i održavanje”
English: The white to off-white tablets are imprinted with “SC800” on one side.
Croatian: Bijele do bjelkaste tablete na jednoj strani imaju otisnutu oznaku „SC800”.
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 korist dojenja za dijete i korist od liječenja sevelamerkarbonatom za majku.
English: The potential risk of Sevelamer carbonate Winthrop during human pregnancy is unknown.
Croatian: Mogući rizik uzimanja lijeka Sevelamer carbonate Winthrop tijekom trudnoće nije poznat.
English: • if you have problems with motility (movement) in your stomach and bowel
Croatian: • imate problema s motilitetom (pokretljivošću) želuca i crijeva
English: BSA (m2)
Croatian: Površina tijela (m2)
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 peritonejskoj dijalizi (kada se tekućina pumpa u trbušnu šupljinu, a unutarnja tjelesna membrana filtrira krv);
English: The recommended starting dose of this medicine for adults and elderly is one to two tablets of 800 mg with each meal, 3 times a day.
Croatian: Preporučena početna doza lijeka za odrasle i starije osobe je jedna do dvije tablete od 800 mg uz svaki obrok 3 puta na dan.
English: If you consider stopping your Sevelamer carbonate Winthrop treatment, contact your doctor or pharmacist first.
Croatian: Ako razmišljate o prestanku uzimanja lijeka Sevelamer carbonate Winthrop, obratite se najprije svom liječniku ili ljekarniku.
English: The sachet has to be discarded after 24 hours of opening.
Croatian: Vrećica se mora baciti 24 sata nakon otvaranja.
English: There are no or limited amount of data from the use of sevelamer in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni sevelamera u trudnica ograničeni.
English: Take Sevelamer carbonate Winthrop after your meal or with food.
Croatian: Uzmite lijek Sevelamer carbonate Winthrop sa obrokom ili nakon obroka.
English: • Medicines treating heartburn and reflux from your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may reduce the efficacy of Sevelamer carbonate Winthrop.
Croatian: • Lijekovi za liječenje žgaravice i vraćanje kiseline iz želuca ili jednjaka, kao što su omeprazol, pantoprazol ili lanzoprazol, poznati i kao „inhibitori protonske pumpe“, mogu smanjiti djelotvornost lijeka Sevelamer carbonate Winthrop.
English: However the potential absorption and accumulation of sevelamer during long-term chronic treatment (> one year) cannot be totally excluded.
Croatian: Međutim, ne može se u potpunosti isključiti potencijal apsorpcije i akumulacije sevelamera tijekom dugotrajnog kroničnog liječenja (duljeg od godine dana).
English: Follow the diet prescribed by your doctor.
Croatian: Pridržavajte se dijete koju Vam je liječnik propisao.
English: A total of 101 patients (6 to 18 years old with a BSA range of 0.8 m2 to 2.4 m2) were randomised in the study.
Croatian: Ukupno je 101 bolesnik randomiziran za ispitivanje (u dobi od 6 do 18 godina s tjelesnom površinom u rasponu od 0,8 m2 do 2,4 m2).
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: Ako imate daljnja pitanja o uporabi ovoga lijeka, obratite se svom liječniku ili ljekarniku.
English: • Sevelamer carbonate Winthrop should not be taken at the same time as ciprofloxacin (an antibiotic).
Croatian: • Sevelamer carbonate Winthrop se ne bi smio uzimati istodobno s ciprofloksacinom (antibiotik).
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 folatne kiseline.
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 folatne kiseline u krvi te će ih stoga liječnik možda pratiti i po potrebi Vam propisati vitaminsku dopunu.
English: Children and adolescents (>6 years of age and a BSA of >0.75m2):
Croatian: Djeca/adolescenti (>6 godina starosti i površine tijela >0,75 m2)
English: Contents of the pack and other information What Sevelamer carbonate Winthrop contains
Croatian: Sadržaj pakiranja i druge informacije Što Sevelamer carbonate Winthrop sadrži
English: Your doctor should monitor the level of bicarbonate in your blood.
Croatian: Vaš liječnik bi trebao pratiti razinu bikarbonata u krvi.
English: Talk to your doctor before taking Sevelamer carbonate Winthrop : • if you have problems with motility (movement) in your stomach and bowel
Croatian: Obratite se svom liječniku prije nego što uzmete Sevelamer carbonate Winthrop ako: • imate problema s motilitetom (pokretljivošću) želuca i crijeva
English: • if you have active inflammation of the bowel • if you have undergone major surgery on your stomach or bowel.
Croatian: • imate aktivnu upalu crijeva • imali ste veliku operaciju želuca ili crijeva
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: 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 m2 treba biti primijenjena oralna suspenzija, budući da tablete nisu ispitane u ovoj populaciji i stoga nisu prikladne za ovu populaciju.
English: Additional treatments: Due to either your kidney condition or your dialysis treatment you may:
Croatian: Kao posljedicu bubrežne bolesti ili liječenja dijalizom možete:
English: The most serious adverse reactions are hypersensitivity (very rare frequency), intestinal obstruction (not known frequency), ileus/subileus (not known frequency), intestinal perforation (not known frequency), serious inflammatory gastrointestinal disorders associated with the presence of sevelamer crystals (not known frequency).
Croatian: Najozbiljnije nuspojave su preosjetljivost (vrlo rijetka učestalost), opstrukcija crijeva (nepoznata učestalost), ileus/subileus (nepoznata učestalost), perforacija crijeva (nepoznata učestalost) te ozbiljni gastrointestinalni upalni poremećaji povezani s prisutnošću kristala sevelamera (nepoznata učestalost).
English: For children, the powder is preferred, as tablets are not appropriate for this population.
Croatian: Za djecu se preporuča prašak jer tablete nisu prikladne za ovu populaciju.
English: Taking your Sevelamer carbonate Winthrop treatment is important to maintain an appropriate phosphate level in your blood.
Croatian: Uzimanje lijeka Sevelamer carbonate Winthrop je važno za održavanje odgovarajuće razine fosfata u krvi.
English: Each sachet of 0.8 g of powder is to be dispersed in 30 mL of water prior to administration (see section 6.6).
Croatian: Svaka vrećica od 0,8 g praška mora se prije primjene rastopiti u 30 ml vode (vidjeti dio 6.6).
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 peritonejskoj dijalizi, a u kliničkom ispitivanju sevelamerklorida prijavljen je veći broj slučajeva peritonitisa u skupini liječenoj sevelamerkloridom nego u kontrolnoj skupini.
English: Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and may adjust the dose of Sevelamer carbonate Winthrop 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 Sevelamer carbonate Winthrop kako bi se postigle odgovarajuće razine fosfata.
English: He will base the dose on your serum phosphorus level.
Croatian: On će odrediti Vašu dozu na temelju razine fosfora u serumu.
English: • slow intestine motility (movement).
Croatian: • spori motilitet (pokretljivost) crijeva
English: Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials.
Croatian: Bolesnici koji uzimaju antiaritmike za kontrolu aritmija i lijekove protiv napadaja za kontrolu napadaja nisu bili uključeni u klinička ispitivanja, stoga se moguće smanjenje apsorpcije ne može isključiti.
English: - The other ingredients are microcrystalline cellulose, sodium chloride, zinc stearate, hypromellose (E464), diacetylated monoglycerides, iron oxide black (E172), isopropyl alcohol, propylene glycol and hypromellose (E464).
Croatian: - Drugi sastojci su mikrokristalična celuloza, natrijev klorid, cinkov stearat, hipromeloza (E464), diacetilirani monogliceridi, crni željezov oksid (E172), izopropilni alkohol i propilenglikol.
English: Paediatric dose based on BSA (m2)
Croatian: Pedijatrijska doza temeljena na površini tijela (m2) Površina tijela (m2)
English: The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
Croatian: Sigurnost primjene sevelamera (u obliku karbonata ili klorida) ispitana je u brojnim kliničkim ispitivanjima s ukupno 969 bolesnika na hemodijalizi čije je liječenje trajalo od 4 do 50 tjedana (724 bolesnika liječena su sevelamerkloridom, a 245 sevelamerkarbonatom), 97 bolesnika na peritonejskoj dijalizi čije je liječenje trajalo 12 tjedana (svi su liječeni sevelamerkloridom) i 128 bolesnika s kroničnom bubrežnom bolešću koji nisu bili na dijalizi, čije je liječenje trajalo od 8 do 12 tjedana (79 bolesnika liječeno je sevelamerkloridom, a 49 sevelamerkarbonatom).
English: Do not heat Sevelamer carbonate Winthrop powder (e.g. microwave) or add to hot foods or liquids.
Croatian: Nemojte zagrijavati Sevelamer carbonate Winthrop prašak (npr. u mikrovalnoj pećnici) niti ga dodavati u vruću hranu ili tekućine.
English: For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Sevelamer carbonate Winthrop 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) Sevelamer carbonate Winthrop se mora davati gram za gram, uz praćenje razina fosfora u serumu kako bi se osigurala primjena optimalnih dnevnih doza.
English: It is unknown whether Sevelamer carbonate Winthrop is excreted in breast milk and may affect your baby.
Croatian: Nije poznato izlučuje li se Seevelamer carbonate Winthrop u majčino mlijeko i utječe li na dijete.
English: Each sachet of 2.4 g of powder is to be dispersed in 60 ml of water prior to administration (see section 6.6).
Croatian: Svaka vrećica od 2,4 g praška mora se prije primjene rastopiti u 60 ml vode (vidjeti dio 6.6).
English: The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class: nausea (very common), vomiting (very common), upper abdominal pain (very common), constipation (very common), diarrhea (common), dyspepsia (common) and flatulence (common).
Croatian: Sve najčešće nuspojave (≥ 5% bolesnika) pripadale su u poremećaje probavnog sustava: mučnina (vrlo često), povraćanje (vrlo često), bol u gornjem dijelu abdomena (vrlo često), konstipacija (vrlo često), proljev (često), dispepsija (često) i flatulencija (često).
English: Constipation can be an early symptom of serious gastrointestinal adverse reactions.
Croatian: Konstipacija može biti rani simptom ozbiljnih gastrointestinalnih nuspojava.
English: In patients undergoing peritoneal dialysis additional monitoring of fat-soluble vitamins and folic acid is recommended, since vitamin A, D, E and K levels were not measured in a clinical study in these patients.
Croatian: U bolesnika na peritonejskoj dijalizi preporučuje se dodatno praćenje razine vitamina topivih u mastima i folatne kiseline, jer se u kliničkom ispitivanju u tih bolesnika nisu mjerile vrijednosti vitamina A, D, E i K.
English: Sevelamer carbonate Winthrop powder should not be heated (e.g. microwave) or added to heated foods or liquids.
Croatian: Sevelamer carbonate Winthrop prašak se ne smije zagrijavati (npr. u mikrovalnoj pećnici) niti dodavati u zagrijanu hranu ili tekućine.
English: o Hold the dosing spoon horizontally and pour the powder out of the sachet into the dosing spoon.
Croatian: o Držite dozirnu žličicu horizontalno i istresite prašak iz vrećice u dozirnu žličicu.
English: Serum calcium levels should therefore be monitored at regular intervals and elemental calcium should be given as a supplement if required.
Croatian: Potrebno je u redovitim intervalima nadzirati razine kalcija u serumu te po potrebi davati dopunu elementarnog kalcija.
English: Do not use this medicine after the expiry date stated on the bottle and/or carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i/ili kutiji iza oznake „EXP”.
English: o Do not tap the dosing spoon to compact the powder.
Croatian: . o Ne tapkajte žličicu za doziranje kako biste istisnuli prašak.
English: Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative BSA.
Croatian: Ispitivanja na životinjama pokazala su da sevelamer nije štetno utjecao na plodnost mužjaka ili ženki štakora pri ekspoziciji dozama koje na temelju usporedbe relativne tjelesne površine odgovaraju dvostrukoj maksimalnoj dozi za ljude u kliničkim ispitivanjima od 13 g/dan.
English: These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystal deposit in your bowel.
Croatian: Ovi se simptomi mogu javiti zbog ozbiljne upalne bolesti crijeva, koju uzrokuje nakupljanje kristala sevelamerkarbonata u crijevima.
English: Your doctor may monitor the phosphate level in your blood.
Croatian: Liječnik će možda pratiti razinu fosfata u krvi.
English: Sevelamer carbonate Winthrop is unlikely to affect your ability to drive or to use machines.
Croatian: Nije vjerojatno da će Sevelamer carbonate Winthrop utjecati na sposobnost upravljanja vozilima i strojevima.