FrancophonIA/ELRC3.0 huggingface dataset:
English: uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
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: Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as bleeding, perforation, ulceration, necrosis, colitis, …) associated with the presence of sevelamer crystals have been reported in literature.
Croatian: Slučajevi ozbiljnih upalnih poremećaja različitih dijelova gastrointestinalnog trakta (uključujući ozbiljne komplikacije kao što su krvarenje, perforacija, ulceracija, nekroza, kolitis, ... ) povezani s prisutnošću kristala sevelamera prijavljeni su u literaturi.
English: Genzyme Ltd.
Croatian: Genzyme Ireland Ltd.
English: Since constipation may be a preceding symptom in very rare cases of blockages in your intestine, it is important to inform your doctor or pharmacist of this symptom before or during the use of Tasermity.
Croatian: S obzirom da zatvor može biti simptom koji u vrlo rijetkim slučajevima prethodi začepljenju crijeva, važno je da obavijestite svog liječnika ili ljekarnika o ovom simptomu prije ili tijekom korištenja lijeka Tasermity.
English: Sevelamer hydrochloride must be taken three times per day with meals.
Croatian: Sevelamerklorid se mora uzimati triput na dan uz obrok.
English: • Tasermity should not be taken at the same time as ciprofloxacin (an antibiotic).
Croatian: • Tasermity se ne bi smio uzimati istodobno s ciprofloksacinom (antibiotik).
English: The average actual daily dose used in the chronic phase of a one year clinical study was 7 grams of sevelamer hydrochloride.
Croatian: Prosječna stvarna dnevna doza koja se primjenjivala u kroničnoj fazi jednogodišnjeg kliničkog ispitivanja bila je 7 grama sevelamerklorida.
English: Initially your doctor will check the levels of phosphate in your blood every 2-3 weeks and may adjust the dose of Tasermity when necessary (between 1 and 5 tablets of 800 mg per meal) to reach an adequate phosphate level.
Croatian: U početku će liječnik provjeravati razine fosfata u krvi svakih 2-3 tjedna te će po potrebi prilagoditi dozu lijeka Tasermity (između 1 i 5 tableta od 800 mg po obroku) kako bi se postigla odgovarajuća razina fosfata.
English: What Tasermity looks like and contents of the pack
Croatian: Kako Tasermity izgleda i sadržaj pakiranja
English: One gram of sevelamer hydrochloride contains approximately 180 mg (5.1 mEq) chloride.
Croatian: Jedan gram sevelamerklorida sadrži približno 180 mg (5,1 mEq) klorida.
English: Therefore, patients on PD should be closely monitored to ensure the reliable 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 peritonealnoj dijalizi kako bi se osigurala pouzdana primjena odgovarajuće aseptičke tehnike te brzo prepoznavanje i liječenje svih znakova i simptoma povezanih s peritonitisom.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V..
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL with Blue Box - 1 BOTTLE OF 180 TABLETS 800 mg WITHOUT OUTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA s plavim okvirom - 1 BOCA SA 180 TABLETA OD 800 mg BEZ KUTIJE
English: The recommended starting dose of sevelamer hydrochloride is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level.
Croatian: Preporučena početna doza sevelamerklorida je 2,4 g ili 4,8 g na dan, ovisno o kliničkim potrebama i razini fosfora u serumu.
English: • if you have problems with motility (movement) in your stomach and bowel
Croatian: • ako imate problema s motilitetom (pokretljivošću) želuca i crijeva
English: Closer monitoring of TSH levels is therefore recommended in patients receiving both medicinal products.
Croatian: Stoga se preporučuje pozorno praćenje razina TSH-a u bolesnika koji primaju oba lijeka.
English: Do not crush, chew or break into pieces prior to swallowing.
Croatian: Nemojte ih drobiti, žvakati ili lomiti na dijelove prije gutanja.
English: These amines become partially protonated in the intestine and interact with phosphate molecules through ionic and hydrogen bonding.
Croatian: Ti amini postaju djelomično protonirani u crijevima i ulaze u interakcije s molekulama fosfata putem ionskih i vodikovih veza.
English: Tasermity is unlikely to affect your ability to drive or to use machines.
Croatian: Nije vjerojatno da će Tasermity utjecati na vašu sposobnost upravljanja vozilima i strojevima.
English: • Hypersensitivity to sevelamer or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na sevelamer ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: Do not use this medicine after the expiry date stated on the bottle after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici iza oznake “Rok valjanosti”.
English: Genzyme Ireland Ltd. IDA Industrial Park Old Kilmeaden Road Waterford
Croatian: Genzyme Ireland Limited IDA Industrial Park Old Kilmeaden Road Waterford
English: There is at present insufficient data to exclude the possibility of folate deficiency during long term sevelamer hydrochloride treatment.
Croatian: Trenutno nema dovoljno podataka da bi se mogla isključiti mogućnost manjka folata tijekom dugotrajnog liječenja sevelamerkloridom.
English: Each bottle contains 180 film-coated tablets.
Croatian: Jedna boca sadrži 180 filmom obloženih tableta.
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 hydrochloride, 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 primjene ili djelotvornost, taj se lijek mora primijeniti najmanje jedan sat prije ili tri sata nakon sevelamerklorida, ili liječnik mora razmotriti praćenje razina u krvi.
English: What Tasermity is and what it is used for
Croatian: Što je Tasermity i za što se koristi
English: Deficits in skeletal ossification were observed in several locations in fetuses of female rats dosed with sevelamer at 8-20 times the maximum human dose of 200 mg/kg.
Croatian: Deficiti osifikacije primijećeni su na nekoliko skeletnih mjesta na plodovima ženki štakora kojima je sevelamer primijenjen u dozi 8-20 puta većoj od najviše doze za ljude od 200 mg/kg.
English: • In certain people taking levothyroxine (a thyroid hormone) and Tasermity, increased levels of thyroid stimulating hormone (TSH, a substance in your blood which helps control your body's chemical functions) may very rarely be observed.
Croatian: • U nekih osoba koje uzimaju levotiroksin (hormon štitnjače) i Tasermity vrlo rijetko može doći do povišenja razine hormona koji stimulira štitnjaču (TSH, tvari u krvi koja pomaže u regulaciji kemijskih funkcija Vašeg tijela).
English: Serum phosphate should be tested every two to three weeks until a stable serum phosphate level is reached and on a regular basis thereafter.
Croatian: Razinu fosfata u serumu treba provjeravati svaka dva do tri tjedna dok se ne postigne stabilna koncentracija fosfata u serumu te redovito nakon toga.
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: Pack size: 1 bottle of 180 tablets
Croatian: Veličina pakiranja: 1 boca sa 180 tableta
English: Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, the Netherlands
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, Nizozemska
English: Pharmacotherapeutic group: Treatment of hyperphosphatemia.
Croatian: Farmakoterapijska skupina: lijekovi za liječenje hiperfosfatemije.
English: If you forget to take Tasermity
Croatian: Ako ste zaboravili uzeti Tasermity
English: It contains multiple amines separated by one carbon from the polymer backbone.
Croatian: Sadrži brojne amine koji su od polimerne okosnice odvojeni jednim ugljikom.
English: In some cases where Tasermity 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 Tasermity intake, or he/she may consider monitoring the blood levels of that medicine.
Croatian: U nekim slučajevima kada Tasermity morate uzimati istodobno s drugim lijekom, liječnik Vam može preporučiti da taj lijek uzmete 1 sat prije ili 3 sata nakon uzimanja lijeka Tasermity ili može razmotriti praćenje razina tog lijeka u krvi.
English: Therefore your doctor may monitor the levels of TSH in your blood more closely.
Croatian: Stoga će liječnik možda pažljivije pratiti vrijednosti TSH-a u krvi.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove (EMA): http://www.ema.europa.eu
English: • If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor before taking Tasermity.
Croatian: • Ako uzimate lijekove za liječenje tegoba sa srčanim ritmom ili epilepsije, morate se savjetovati sa svojim liječnikom prije nego što uzmete Tasermity.
English: Serum chloride
Croatian: Klorid u serumu
English: Patients receiving dialysis are subject to certain risks for infection specific to the dialysis modality.
Croatian: Bolesnici na dijalizi izloženi su određenim rizicima od infekcije specifične za pojedinu vrstu dijalize.
English: Sevelamer hydrochloride is not absorbed and may affect the bioavailability of other medicinal products.
Croatian: Sevelamerklorid se ne apsorbira i može utjecati na bioraspoloživost ostalih lijekova.
English: In reproduction studies there was no evidence that sevelamer induced embryolethality, foetotoxicity or teratogenicity at the doses tested (up to 1 g/kg/day in rabbits and up to 4.5 g/kg/day in rats).
Croatian: U ispitivanjima reprodukcije nije bilo dokaza da sevelamer inducira letalitet embrija, fetotoksičnost ni teratogenost pri ispitivanim dozama (do 1 g/kg/dan kod kunića te do 4,5 g/kg/dan kod štakora).
English: • if you have swallowing problems
Croatian: • ako imate problema s gutanjem
English: 37 Hollands Road Haverhill, Suffolk CB9 8PU United Kingdom
Croatian: Genzyme Ltd 37 Hollands Road Haverhill, Suffolk CB9 8PU Velika Britanija
English: Sevelamer hydrochloride has been given to normal healthy volunteers in doses up to 14 grams, the equivalent of seventeen 800 mg tablets, per day for eight days with no undesirable effects.
Croatian: Sevelamerklorid se davao normalnim, zdravim dobrovoljcima u dozama do 14 grama na dan, što odgovara količini od 17 tableta od 800 mg na dan, tijekom osam dana bez neželjenih učinaka.
English: Pharmacokinetic studies have not been carried out in renal failure patients (see section 4.4).
Croatian: Nisu provedena farmakokinetička ispitivanja u bolesnika sa zatajenjem bubrega (vidjeti dio 4.4).
English: - The other ingredients are silica colloidal anhydrous and stearic acid, hypromellose (E464), diacetylated monoglycerides, iron oxide black (E172) and propylene glycol.
Croatian: - Drugi sastojci su bezvodni koloidni silicijev dioksid i stearatna kiselina, hipromeloza (E464), diacetilirani monogliceridi, crni željezov oksid (E172) i propilenglikol.
English: Consequently, sevelamer hydrochloride should not be taken simultaneously with ciprofloxacin.
Croatian: Stoga se sevelamerklorid ne bi smio uzimati istodobno s ciprofloksacinom.
English: Not known (frequency cannot be estimated from the available data): cases of itching, rash, abdominal pain, slow intestine motility (movement), blockages in the intestine, inflammation of abnormal small pouches (called diverticula) in the large intestine and perforation in the intestine wall have been reported.
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): prijavljeni su slučajevi svrbeža, osipa, boli u trbuhu, sporog motiliteta (pokretljivost) crijeva, blokade crijeva, upale malih vrećica (koje se nazivaju divertikuli) u debelom crijevu i puknuća stijenke crijeva.
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 prema klasifikaciji organskih sustava među poremećaje probavnog sustava.
English: When you switch from another phosphate binder to Tasermity, your doctor might consider monitoring the levels of bicarbonate in your blood more closely because Tasermity may decrease the levels of bicarbonate.
Croatian: Kada prelazite s liječenja nekim drugim vezačem fosfata na Tasermity, liječnik može razmisliti o tome da pozornije prati razine bikarbonata u krvi, jer Tasermity može smanjiti razine bikarbonata.
English: Closer monitoring of serum bicarbonate levels is therefore recommended.
Croatian: Stoga se preporučuje pozornije praćenje razina bikarbonata u serumu.
English: However, in vitro and in vivo studies have indicated that sevelamer does not have genotoxic potential.
Croatian: Međutim, ispitivanja in vitro i in vivo indiciraju da sevelamer nema genotoksičan potencijal.
English: Serum phosphate levels should be closely monitored and the dose of sevelamer hydrochloride titrated by 0.8 g three times per day (2.4 g/day) increments with the goal of lowering serum phosphate to 1.76 mmol/L (5.5 mg/dl) or less.
Croatian: Neophodno je pozorno pratiti razine fosfata u serumu i titrirati dozu sevelamerklorida u koracima po 0,4 g ili 0,8 g tri puta dnevno (1,2 g/dan ili 2,4 g/dan) s ciljem smanjenja koncentracije fosfata u serumu na 1,76 mmol/L (5,5 mg/dl) ili manje.
English: In animal studies there was no evidence that sevelamer induced embryo-foetal toxicity.
Croatian: U istraživanjima na životinjama nije bilo dokaza da sevelamer uzrokuje embriofetalnu toksičnost.
English: Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical study with sevelamer hydrochloride, a number of peritonitis cases were reported.
Croatian: Peritonitis je poznata komplikacija u bolesnika koji su na peritonealnoj dijalizi (PD), a u kliničkom ispitivanju sevelamerklorida prijavljen je određen broj slučajeva peritonitisa.
English: Do not crush, chew or break into pieces prior to administration.
Croatian: Ne smiju se drobiti, žvakati ili lomiti na dijelove prije primjene.
English: Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia.
Croatian: Bolesnici s bubrežnom insuficijencijom mogu razviti hipokalcijemiju ili hiperkalcijemiju.
English: Patients with chronic renal failure are predisposed to developing metabolic acidosis.
Croatian: Bolesnici s kroničnim zatajenjem bubrega imaju predispoziciju za razvoj metaboličke acidoze.
English: Increased levels of serum phosphorus can lead to hard deposits in your body called calcification.
Croatian: Povišene razine fosfora u serumu mogu izazvati stvaranje krutih naslaga u tijelu, što se zove kalcifikacija.
English: In interaction studies in healthy volunteers, sevelamer hydrochloride had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Croatian: U ispitivanjima interakcija u zdravih dobrovoljaca, sevelamerklorid nije utjecao na bioraspoloživost digoksina, varfarina, enalaprila ili metoprolola.
English: It binds phosphate from food in the digestive tract and so reduces serum phosphate levels in the blood.
Croatian: On veže fosfate iz hrane u probavnom sustavu i na taj način snižava razine serumskog fosfata u krvi.
English: Efficacy and safety of sevelamer hydrochloride has not been studied in patients with:
Croatian: Djelotvornost i sigurnost sevelamerklorida nije ispitana u bolesnika:
English: • if you have symptoms of delayed emptying of stomach contents such as feeling of fullness,
Croatian: • ako imate simptome odgođenog pražnjenja želučanog sadržaja kao što su osjećaj punoće, mučnina i/ili povraćanje
English: Sevelamer decreases the incidence of hypercalcaemic episodes as compared to patients using calcium based phosphate binders alone, probably because the product itself does not contain calcium.
Croatian: Sevelamer smanjuje incidenciju epizoda hiperkalcijemije u odnosu na bolesnike koji uzimaju samo vezače fosfata na bazi kalcija, vjerojatno zato što sam lijek ne sadrži kalcij.
English: Although no clinically significant serum chloride increase has been observed in the clinical studies, serum chloride should be monitored as is done in the routine follow-up of a dialysis patient.
Croatian: Iako u kliničkim ispitivanjima nije primijećeno klinički značajno povećanje vrijednosti klorida u serumu, potrebno je nadzirati razinu klorida u serumu kao što se to radi u rutinskom praćenju bolesnika na dijalizi.
English: Anti-arrhythmics and anti-seizure medicinal products 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.
English: *post-marketing experience
Croatian: *iskustvo nakon stavljanja lijeka u promet
English: Tasermity should only be given to pregnant or breast-feeding women if clearly needed.
Croatian: Tasermity se smije davati trudnicama i dojiljama samo kada je to prijeko potrebno.
English: Uncommon (may affect up to 1 in 100 people): increased acidity of the blood.
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): povećana kiselost krvi
English: Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when coadministered with sevelamer hydrochloride without any clinical consequences (i.e graft rejection).
Croatian: Ciklosporin, mikofenolat mofetil i takrolimus u transplantiranih bolesnika Zabilježene su snižene vrijednosti ciklosporina, mikofenolat mofetila i takrolimusa u transplantiranih bolesnika kod istodobne primjene sevelamerklorida, bez kliničkih posljedica (npr. odbacivanja presatka).
English: Talk to your doctor before taking Tasermity if any of the following applies to you:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego što uzmete Tasermity ako se nešto od navedenog odnosi na Vas:
English: Inflammatory Gastrointestinal Disorders
Croatian: Upalni gastrointestinalni poremećaji
English: Tasermity 800 mg
Croatian: 800 mg
English: Adult patients whose kidneys have failed and who are undergoing haemodialysis or peritoneal dialysis are not able to control the level of serum phosphate in their blood.
Croatian: Odrasli bolesnici sa zatajenjem bubrega koji su na hemodijalizi ili peritonealnoj dijalizi ne mogu kontrolirati razinu serumskog fosfata u krvi.
English: You should expect to be monitored more carefully for problems with low levels of vitamins A, D, E, K and folic acid.
Croatian: Trebate očekivati da će se provoditi pažljivije kontrole kako bi se uočili mogući problemi zbog niskih razina vitamina A, D, E, K i folne kiseline.
English: Very rare (may affect up to 1 in 10000 people): hypersensitivity.
Croatian: Vrlo rijetko (mogu se javiti u manje od 1 na 10000 osoba): preosjetljivost.
English: In the clinical studies in haemodialysis patients, sevelamer hydrochloride alone did not have a consistent and clinically significant effect on serum intact parathyroid hormone (iPTH).
Croatian: U kliničkim ispitivanjima u bolesnika na hemodijalizi sevelamerklorid sam nije imao konzistentan i klinički značajan učinak na razinu intaktnog paratiroidnog hormona (iPTH) u serumu.
English: However, the causality of the sevelamer crystals in initiating such disorders has not been demonstrated.
Croatian: Međutim, uzročno posljedična poveznost između prisustva kristala sevelamera i razvoja ovakvih poremećaja nije dokazana.
English: Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels.
Croatian: Ovisno o unosu hrane i naravi terminalne faze zatajenja bubrega, u bolesnika na dijalizi mogu se razviti niske razine vitamina A, D, E i K.
English: In preclinical studies in rats and dogs, sevelamer at a dose of 10 times the maximum human doses reduced absorption of fat soluble vitamins D, E and K, and folic acid.
Croatian: U pretkliničkim ispitivanjima na štakorima i psima sevelamer u dozi 10 puta većoj od maksimalne doze za ljude smanjio je apsorpciju vitamina D, E i K topivih u mastima i folne 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
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: Serum chloride may increase during sevelamer hydrochloride treatment as chloride may be exchanged for phosphorus in the intestinal lumen.
Croatian: Količina klorida u serumu može se povećati tijekom liječenja sevelamerkloridom jer se klorid može zamijeniti fosforom u crijevnom lumenu.
English: He/she will base the dose on your serum phosphate level.
Croatian: On će odrediti Vašu dozu na temelju razine fosfata u serumu.
English: In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
Croatian: Međutim, u 12-tjednom ispitivanju koje je uključivalo bolesnike na peritonealnoj dijalizi, uočena su podjednaka smanjenja vrijednosti iPTH-a kao u bolesnika koji su primali kalcijev acetat.
English: Tasermity tablets are film-coated, off-white, oval tablets with “SH800” imprinted on one side.
Croatian: Tasermity tablete su filmom obložene, bjelkaste, ovalne tablete, s otisnutom oznakom „SH800“ na jednoj strani.
English: The safety and efficacy of this product have not been established in patients below the age of 18 years.
Croatian: Pedijatrijska populacija Sigurnost primjene i djelotvornost ovog lijeka nisu ustanovljene u bolesnika mlađih od 18 godina.
English: In a clinical trial of one-year duration, sevelamer hydrochloride had no adverse effect on bone turnover or mineralisation compared to calcium carbonate.
Croatian: U kliničkom ispitivanju u trajanju od jedne godine sevelamerklorid nije imao štetne učinke na koštanu pregradnju ni mineralizaciju u usporedbi s kalcijevim karbonatom.
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 usta i jednjaka.
English: It cannot be excluded that sevelamer hydrochloride can bind fat-soluble vitamins contained in ingested food.
Croatian: Ne može se isključiti mogućnost da sevelamerklorid veže vitamine topive u mastima iz konzumirane hrane.