FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients previously on phosphate binders, Sevelamer hydrochloride 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 se mora davati gram po gram uz praćenje razina fosfora u serumu kako bi se osigurala primjena optimalnih dnevnih doza.
English: The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of mycophenolate mofetil, ciclosporin and tacrolimus should be considered during the use of combination and after its withdrawal.
Croatian: Ne može se isključiti mogućnost interakcije te treba razmotriti pozorno praćenje koncentracija mikofenolat mofetila, ciklosporina i takrolimusa u krvi tijekom i nakon kombinirane primjene sa sevelamerkloridom.
English: Tasermity contains sevelamer, a non-absorbed phosphate binding poly (allylamine hydrochloride) polymer, free of metal and calcium.
Croatian: Tasermity sadrži sevelamer, neapsorbirajući poli (alilamin klorid) polimer koji veže fosfate, a ne sadrži metale ni kalcij.
English: Additional monitoring of vitamins and folic acid is recommended in patients receiving peritoneal dialysis, since in the clinical study, vitamin A, D, E and K levels were not measured in these patients.
Croatian: U bolesnika na peritonealnoj dijalizi preporučuje se dodatno praćenje razine vitamina i folne kiseline jer se u kliničkom ispitivanju u tih bolesnika nisu mjerile vrijednosti vitamina A, D, E i K.
English: Closer monitoring of patients with hypothyroidism co-administered with sevelamer hydrochloride and levothyroxine is recommended (see section 4.5).
Croatian: Preporučuje se pozornije praćenje bolesnika koji pate od hipotireoze i istodobno uzimaju sevelamerklorid i levotiroksin (vidjeti dio 4.5).
English: Iron oxide black (E172) Propylene glycol Hypromellose (E464)
Croatian: Tinta za označavanje: željezov oksid, crni (E172) propilenglikol hipromeloza (E464)
English: In a study in rats, administering sevelamer in 15-30 x the human dose, an increase in serum copper was detected.
Croatian: U ispitivanju na štakorima kojima je primijenjen sevelamer u dozi 15-30 puta većoj od doze za ljude utvrđeno je povećanje koncentracije bakra u serumu.
English: Sevelamer hydrochloride 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 (see section 5.3).
Croatian: Sevelamerklorid se smije davati trudnicama samo ako je to prijeko potrebno i nakon pažljive analize rizika i koristi kako za majku tako i za fetus (vidjeti dio 5.3).
English: Worsening of acidosis has been reported upon switching from other phosphate binders to sevelamer in a number of studies where lower bicarbonate levels in the sevelamer-treated patients compared to patients treated with calcium-based binders were observed.
Croatian: U više je ispitivanja zabilježeno pogoršanje acidoze nakon prelaska s drugih vezača fosfata na sevelamer, pri čemu su opažene niže razine bikarbonata u bolesnika liječenih sevelamerom u usporedbi s bolesnicima liječenima vezačima na bazi kalcija.
English: Serum calcium levels should be monitored as is done in normal follow-up of a dialysis patient.
Croatian: Potrebno je nadzirati razine kalcija u serumu kako je to uobičajeno kod praćenja bolesnika na dijalizi.
English: Sevelamer hydrochloride treatment should be re-evaluated in patients who develop severe gastrointestinal symptoms.
Croatian: Liječenje sevelamerkloridom treba ponovno razmotriti u bolesnika koji razviju teške gastrointestinalne simptome.
English: Genzyme Europe B.V. Gooimeer 10
Croatian: Genzyme Europe B.V.
English: Uncommon Very Rare
Croatian: Vrlo rijetko
English: By binding phosphate in the gastrointestinal tract, sevelamer lowers the phosphate concentration in the serum.
Croatian: Vezujući fosfate u gastrointestinalnom traktu sevelamer snižava koncentraciju fosfora u serumu.
English: Sevelamer hydrochloride should only be given to breast-feeding women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the infant (see section 5.3).
Croatian: Sevelamerklorid se smije davati dojiljama samo ako je to prijeko potrebno i nakon pažljive analize rizika i koristi kako za majku tako i za dojenče (vidjeti dio 5.3).
English: How to take Tasermity
Croatian: Kako uzimati Tasermity
English: EU/1/14/953/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/953/001
English: • If you are taking medicine such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease (GERD), or gastric ulcers, you should consult your doctor when taking Tasermity.
Croatian: • Ako uzimate lijekove za liječenje žgaravice, gastroezofagealne refluksne bolesti (GERB) ili čira na želucu, kao što su omeprazol, pantoprazol ili lanzoprazol, morate se savjetovati sa svojim liječnikom kad uzimate Tasermity.
English: Patients should take sevelamer hydrochloride with meals and adhere to their prescribed diets.
Croatian: Bolesnici moraju uzimati sevelamerklorid uz obroke i pridržavati se propisane dijete.
English: Patients taking Tasermity should adhere to their prescribed diet and liquid intake.
Croatian: Bolesnici koji uzimaju Tasermity se moraju pridržavati propisane dijete i unosa tekućine.
English: Patients who are constipated should be monitored carefully while being treated with sevelamer hydrochloride.
Croatian: Bolesnike koji pate od konstipacije treba pomno nadzirati tijekom liječenja sevelamerkloridom.
English: Tasermity 800 mg film-coated tablets
Croatian: Tasermity 800 mg filmom obložene tablete sevelamerklorid
English: Common (may affect up to 1 in 10 people): diarrhoea, indigestion, abdominal pain, constipation, flatulence.
Croatian: Često (mogu se javiti u do 1 na 10 osoba): proljev, probavne tegobe, bol u trbuhu, zatvor, vjetrovi.
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Tasermity.
Croatian: • Tasermity može umanjiti učinke lijekova kao što su ciklosporin, mikofenolat mofetil i takrolimus (lijekova koji se primjenjuju u bolesnika s presatkom organa).
English: The safety of Tasermity has not been established in pregnant or breast-feeding women.
Croatian: Sigurnost primjene lijeka Tasermity u trudnica i dojilja nije ustanovljena.
English: • patients with a history of major gastrointestinal surgery
Croatian: • koji su prethodno podvrgnuti velikom operativnom zahvatu gastrointestinalnog trakta
English: In interaction studies in healthy volunteers, sevelamer hydrochloride decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with sevelamer hydrochloride in a single dose study.
Croatian: U ispitivanjima interakcija u zdravih dobrovoljaca, prilikom istodobne primjene sevelamerklorida i ciprofloksacina u ispitivanju s primjenom jedne doze, sevelamerklorid je smanjio bioraspoloživost ciprofloksacina za približno 50%.
English: • if you have prolonged diarrhoea or pain in the abdomen (symptoms of active inflammatory bowel disease)
Croatian: • ako imate dugotrajni proljev ili bol u trbuhu (simptomi aktivne upalne bolesti crijeva) • ako ste imali veliku operaciju želuca ili crijeva.
English: Sevelamer hydrochloride alone is not indicated for the control of hyperparathyroidism.
Croatian: Sevelamerklorid sam nije indiciran za kontrolu hiperparatireoze.
English: Sevelamer hydrochloride does not contain calcium.
Croatian: Sevelamerklorid ne sadrži kalcij.
English: The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and an induction seal.
Croatian: Tablete su pakirane u boce od polietilena visoke gustoće s polipropilenskim sigurnosnim čepom za djecu i zalijepljenom zaštitnom folijom.
English: Tasermity contains sevelamer as the active ingredient.
Croatian: Tasermity sadrži djelatnu tvar sevelamer.
English: • gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis,
Croatian: • s poremećajima motiliteta gastrointestinalnog trakta uključujući i neliječenu ili tešku gastroparezu, divertikulozu, retenciju želučanog sadržaja te neuobičajenu ili nepravilnu peristaltiku crijeva
English: Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Croatian: Tasermity je indiciran za kontrolu hiperfosfatemije u odraslih bolesnika koji su na hemodijalizi ili peritonealnoj dijalizi.
English: Sevelamer hydrochloride has no or negligible influence on the ability to drive and use machines.
Croatian: Sevelamerklorid ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The safety of sevelamer hydrochloride has not been established in pregnant women.
Croatian: Sigurnost primjene sevelamerklorida u trudnica nije ustanovljena.
English: During post marketing experience, very rare cases of increased thyroid stimulating hormone (TSH) levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su vrlo rijetki slučajevi povećanih razina tireostimulirajućeg hormona (TSH) u bolesnika koji su istodobno uzimali sevelamerklorid i levotiroksin.
English: Film-coated tablet (tablet) The off-white, oval tablets are imprinted with “SH800” on one side.
Croatian: Bjelkaste, ovalne tablete na jednoj strani imaju otisnutu oznaku “SH800”.
English: Each tablet contains 800 mg sevelamer hydrochloride.
Croatian: Jedna tableta sadrži 800 mg sevelamerklorida.
English: How to store Tasermity
Croatian: Kako čuvati Tasermity
English: In parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks were conducted Adverse reactions from these studies (299 patients), from uncontrolled clinical trials (384 patients) and that were spontaneously reported from post-marketing experience are listed by frequency in the table below.
Croatian: Provedena su usporedna ispitivanja u kojima su sudjelovala 244 bolesnika na hemodijalizi čije je liječenje trajalo najdulje 54 tjedna i 97 bolesnika na peritonealnoj dijalizi čije je liječenje trajalo najdulje 12 tjedana.
English: Tел: +359 2 9705300
Croatian: SANOFI BULGARIA Tел: +359 2 9705300
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/953/001 DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: 180 film-coated tablets
Croatian: OBLIK I SADRŽAJ 180 filmom obloženih tableta
English: Tasermity is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.
Croatian: Tasermity se koristi za reguliranje razina fosfata u krvi u odraslih bolesnika sa zatajenjem bubrega koji su na hemodijalizi ili peritonealnoj dijalizi.
English: Old Kilmeaden Road
Croatian: IDA Industrial Park Old Kilmeaden Road Waterford
English: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride.
Croatian: U vrlo rijetkim slučajevima su tijekom liječenja sevelamerkloridom u bolesnika opaženi opstrukcija crijeva i ileus/subileus.
English: nausea and/or vomiting
Croatian: D i/ili vitamina
English: What you need to know before you take Tasermity Do not take Tasermity:
Croatian: Što morate znati prije nego što počnete uzimati Tasermity
English: In clinical trials, sevelamer hydrochloride has been shown to be effective in reducing serum phosphorus in patients receiving haemodialysis or peritoneal dialysis.
Croatian: Kliničkim je ispitivanjima dokazano da sevelamerklorid djelotvorno smanjuje koncentracije fosfora u serumu u bolesnika koji su na hemodijalizi ili peritonealnoj dijalizi.
English: During post-marketing experience, very rare cases of increased phosphate levels have been reported in patients taking proton pump inhibitors co-administered with sevelamer hydrochloride.
Croatian: Nakon stavljanja lijeka u promet, prijavljeni su vrlo rijetki slučajevi povećanih vrijednosti fosfata u bolesnika koji su istodobno uzimali inhibitore protonske pumpe i sevelamerklorid.
English: Therefore caution should be exercised when sevelamer hydrochloride is used in patients with these disorders.
Croatian: Stoga je potreban oprez pri primjeni sevelamerklorida u bolesnika s tim poremećajima.
English: You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
Croatian: Posebna napomena za bolesnike na peritonealnoj dijalizi Možete razviti peritonitis (infekcija tekućine u trbuhu) povezan s peritonealnom dijalizom.
English: Caution should be exercised when prescribing sevelamer hydrochloride to patients also taking these medicinal products.
Croatian: Potreban je oprez pri propisivanju sevelamerklorida bolesnicima koji uzimaju navedene lijekove.
English: Therefore, in patients not taking these vitamins, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of thromboplastin time should be considered and the vitamins should be supplemented if necessary.
Croatian: Stoga je u bolesnika koji ne uzimaju navedene vitamine potrebno razmotriti praćenje razina vitamina A, D i E i procjenu statusa vitamina
English: - The active substance is sevelamer hydrochloride.
Croatian: - Djelatna tvar je sevelamerklorid.
English: Sevelamer hydrochloride treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Croatian: Treba ponovno procijeniti nastavak liječenja sevelamerkloridom u bolesnika u kojih dođe do teške konstipacije ili se jave drugi teški gastrointestinalni simptomi.
English: Elemental calcium should be given as a supplement in case of hypocalcaemia.
Croatian: U slučaju hipokalcijemije potrebno je propisati nadoknadu elementarnog kalcija.
English: Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose
Croatian: Istraživanja na životinjama pokazala su da sevelamer nije štetno utjecao na plodnost mužjaka ni ženki štakora pri ekspoziciji dozama koje odgovaraju dvostrukoj maksimalnoj dozi za ljude iz kliničkih ispitivanja od 13 g/dan, temeljeno na usporedbi relativne površine tijela.
English: Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Croatian: Sevelamerklorid treba primjenjivati u sklopu multiterapijskog pristupa, koji može uključivati nadomjestke kalcija i 1,25-dihidroksi vitamin D3 ili neki od njegovih analoga, kako bi se kontrolirao razvoj bubrežne osteodistrofije.
English: In patients with secondary hyperparathyroidism sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Croatian: Bolesnici sa sekundarnom hiperparatireozom trebaju uzimati sevelamerklorid u sklopu multiterapijskog pristupa koji može uključivati nadomjestke kalcija te primjenu 1,25-dihidroksi vitamina D3 ili nekog od njegovih analoga kako bi se snizila razina intaktnog paratiroidnog hormona (iPTH).
English: In patients with secondary hyperparathyroidism sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the iPTH levels.
Croatian: Bolesnici sa sekundarnom hiperparatireozom trebaju uzimati sevelamerklorid u sklopu multiterapijskog pristupa, koji može uključivati nadomjestke kalcija te primjenu 1,25-dihidroksi vitamina D3 ili nekog od njegovih analoga kako bi se snizila razina iPTH-a.
English: Uncommon reports of difficulty swallowing the sevelamer hydrochloride tablet have been reported.
Croatian: Manje često su prijavljene poteškoće s gutanjem tableta sevelamerklorida.
English: Caution should be exercised when sevelamer hydrochloride is used in patients with difficulty swallowing.
Croatian: Potreban je oprez kad se sevelamerklorid primjenjuje u bolesnika koji otežano gutaju.
English: Abdominal pain, intestinal obstruction, ileus/subileus, diverticulitis, intestinal perforation
Croatian: Poremećaji probavnog sustava mučnina, povraćanje proljev, dispepsija, flatulencija, bol u gornjem bol u abdomenu, opstrukcija crijeva, ileus/subileus, divertikulitis i perforacija crijeva
English: Renal impairment The safety and efficacy of this product have not been established in predialysis patients.
Croatian: Sigurnost primjene i djelotvornost ovog lijeka nisu ustanovljene u bolesnika koji još nisu bili na dijalizi.
English: Acidosis, increased chloride
Croatian: Poremećaji metabolizma i prehrane acidoza, povećane razine klorida u serumu
English: Tasermity may be used with other medicines which include calcium or vitamin D supplements to control the development of renal bone disease.
Croatian: Tasermity se može primijeniti uz druge lijekove koji uključuju nadomjestke kalcija ili vitamina
English: Silica, colloidal anhydrous Stearic acid
Croatian: Jezgra tablete: silicijev dioksid, koloidni, bezvodni stearatna kiselina
English: HDPE bottles, with a child resistant polypropylene closure and a foil induction seal.
Croatian: Boce od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim čepom za djecu i zalijepljenom zaštitnom folijom.
English: Starting dose of Sevelamer hydrochloride 800 mg tablets
Croatian: Početna doza tableta sevelamerklorida od 800 mg
English: Serum phosphate level in patients not on
Croatian: Razina fosfata u serumu u bolesnika koji ne uzimaju vezače fosfata
English: The following side effects have been reported in patients taking Tasermity: Very common (may affect more than 1 in 10 people): nausea, vomiting
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba): mučnina, povraćanje.
English: Sevelamer hydrochloride is not absorbed from the gastrointestinal tract according to a single dose pharmacokinetic study in healthy volunteers.
Croatian: Prema farmakokinetičkom ispitivanju jedne doze u zdravih dobrovoljaca, sevelamerklorid se ne apsorbira iz gastrointestinalnog trakta.
English: Metabolism and nutrition disorders
Croatian: Antiaritmici i lijekovi protiv napadaja
English: Paediatric population
Croatian: FARMAKOLOŠKA SVOJSTVA
English: The safety of sevelamer hydrochloride has not been established in breast-feeding women.
Croatian: Sigurnost primjene sevelamerklorida u dojilja nije ustanovljena.
English: • if you have bowel obstruction.
Croatian: • ako patite od blokade crijeva
English: Contents of the pack and other information What Tasermity contains
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Tasermity
English: Fat-soluble vitamins
Croatian: Vitamini topivi u mastima
English: Name and address of the manufacturers responsible for batch release Genzyme Ireland Limited
Croatian: Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
English: Waterford
Croatian: FARMACEUTSKI
English: The main measure of effectiveness was the duration of severe neutropenia.
Croatian: Glavna mjera učinkovitosti bilo je trajanje teške neutropenije.
English: What is Nivestim and what is it used for?
Croatian: Što je Nivestim i za što se koristi?
English: Further information on Nivestim can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nivestim.
Croatian: Više informacija o lijeku Nivestim dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/nivestim.
English: Nivestim received a marketing authorisation valid throughout the EU on 8 June 2010.
Croatian: Lijek Nivestim dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 8. lipnja 2010.
English: This means that Nivestim is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: To znači da je Nivestim vrlo sličan drugom biološkom lijeku („referentnom lijeku”) koji je već odobren u EU-u.
English: What measures are being taken to ensure the safe and effective use of Nivestim?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nivestim?
English: An overview of Nivestim and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Nivestim i zašto je odobren u EU-u
English: Other side effects may be seen in more than 1 in 10 patients, depending on the condition that Nivestim is being used for.
Croatian: Druge nuspojave mogu se javiti u više od 1 na 10 bolesnika, ovisno o stanju za koje se Nivestim primjenjuje.
English: Filgrastim works in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Croatian: Filgrastim djeluje na isti način kao i prirodno stvoreni GCSF tako što potiče koštanu srž na stvaranje većeg broja bijelih krvnih stanica.
English: The way Nivestim is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Croatian: Način primjene lijeka Nivestim, njegovo doziranje i trajanje liječenja ovise o svrsi primjene, tjelesnoj težini bolesnika i odgovoru na liječenje.
English: What are the risks associated with Nivestim?
Croatian: Koji su rizici povezani s lijekom Nivestim?
English: Nivestim can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.
Croatian: Nivestim se izdaje samo na recept, a liječenje se mora odvijati u suradnji s centrom za liječenje raka.
English: Nivestim is a medicine that stimulates the production of white blood cells and is used:
Croatian: Nivestim je lijek koji potiče stvaranje bijelih krvnih stanica, a koristi se:
English: Side effects reported with Nivestim are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Nivestim pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The most common side effects with Nivestim (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick).
Croatian: Najčešće nuspojave lijeka Nivestim (koje se mogu javiti u više od 1 na 10 osoba) jesu vrućica, mišićno-koštana bol (bol u mišićima i kostima), anemija (nizak broj crvenih krvnih stanica), povraćanje i mučnina (slabost).
English: The active substance in Nivestim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Croatian: Djelatna tvar u lijeku Nivestim, filgrastim, vrlo je slična ljudskom proteinu koji se zove čimbenik poticanja rasta granulocitnih kolonija (G-CSF).
English: The medicine is available in pre-filled syringes and is given by injection under the skin or infusion (drip) into a vein.
Croatian: Lijek je dostupan u napunjenim štrcaljkama, a daje se supkutanom injekcijom ili infuzijom (ukapavanjem) u venu.
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Croatian: • za povećanje broja neutrofila i smanjenje rizika povezanih s infekcijom u bolesnika s neutropenijom koji imaju povijest teških, ponavljajućih infekcija;
English: In addition, a study in 279 female adult patients with breast cancer who were being treated with cancer medicines showed that Nivestim is comparable to the reference medicine, Neupogen.
Croatian: Osim toga, u ispitivanju na 279 odraslih bolesnica oboljelih od raka dojke koje su primale lijekove protiv raka, utvrđeno je da se Nivestim može usporediti s referentnim lijekom Neupogen.
English: Why is Nivestim approved?
Croatian: Zašto je lijek Nivestim odobren?