natgillin/translations-raw huggingface dataset:
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).
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).
Constipation can be an early symptom of serious gastrointestinal adverse reactions.
Konstipacija može biti rani simptom ozbiljnih gastrointestinalnih nuspojava.
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.
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.
Sevelamer carbonate Winthrop powder should not be heated (e.g. microwave) or added to heated foods or liquids.
Sevelamer carbonate Winthrop prašak se ne smije zagrijavati (npr. u mikrovalnoj pećnici) niti dodavati u zagrijanu hranu ili tekućine.
o Hold the dosing spoon horizontally and pour the powder out of the sachet into the dosing spoon.
o Držite dozirnu žličicu horizontalno i istresite prašak iz vrećice u dozirnu žličicu.
Serum calcium levels should therefore be monitored at regular intervals and elemental calcium should be given as a supplement if required.
Potrebno je u redovitim intervalima nadzirati razine kalcija u serumu te po potrebi davati dopunu elementarnog kalcija.
Do not use this medicine after the expiry date stated on the bottle and/or carton after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i/ili kutiji iza oznake „EXP”.
o Do not tap the dosing spoon to compact the powder.
. o Ne tapkajte žličicu za doziranje kako biste istisnuli prašak.
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.
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.
These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystal deposit in your bowel.
Ovi se simptomi mogu javiti zbog ozbiljne upalne bolesti crijeva, koju uzrokuje nakupljanje kristala sevelamerkarbonata u crijevima.
Your doctor may monitor the phosphate level in your blood.
Liječnik će možda pratiti razinu fosfata u krvi.
Sevelamer carbonate Winthrop is unlikely to affect your ability to drive or to use machines.
Nije vjerojatno da će Sevelamer carbonate Winthrop utjecati na sposobnost upravljanja vozilima i strojevima.
Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when co-administered with sevelamer hydrochloride without any clinical consequences (e.g., graft rejection).
Ciklosporin, mofetilmikofenolat i takrolimus u transplantiranih bolesnika Zabilježene su snižene vrijednosti ciklosporina, mofetilmikofenolata i takrolimusa u transplantiranih bolesnika kod istodobne primjene sevelamerklorida, bez kliničkih posljedica (npr. odbacivanja presatka).
• if you have undergone major surgery on your stomach or bowel.
• imali ste veliku operaciju želuca ili crijeva
Interaction studies have not been conducted in patients on dialysis.
Dijaliza Nisu provedena ispitivanja interakcija u bolesnika na dijalizi.
What Sevelamer carbonate Winthrop looks like and contents of the pack
Kako Sevelamer carbonate Winthrop izgleda i sadržaj pakiranja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - BOTTLE OF 30 TABLETS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - BOČICA S 30 TABLETA
What Sevelamer carbonate Winthrop is and what it is used for
Što je Sevelamer carbonate Winthrop i za što se koristi
The tablets are packed in high density polyethylene bottles with a child-resistant polypropylene closure and an induction seal.
Tablete su pakirane u bočice od polietilena visoke gustoće s polipropilenskim sigurnosnim zatvaračem za djecu i zalijepljenom zaštitnom folijom.
Sevelamer carbonate Winthrop powder for oral suspension is a pale yellow powder supplied in a foil sachet with a heat seal.
Sevelamer carbonate Winthrop prašak za oralnu suspenziju je blijedožuti prašak koji se nalazi u toplinski zalijepljenoj vrećici od folije.
Use the provided dosing spoon for each 0.4 g dose of Sevelamer Carbonate Winthrop powder.
Koristite u pakiranju priloženu dozirnu žličicu za svaku dozu od 0,4 g Sevelamer carbonate Winthrop praška.
Patients who are constipated should be monitored carefully while being treated with sevelamer carbonate.
Bolesnike koji pate od konstipacije treba pomno nadzirati tijekom liječenja sevelamerkarbonatom.
Your doctor can rather prescribe sevelamer carbonate powder for oral suspension.
Vaš liječnik vam može propisati Sevelamer carbonate Winthrop prašak za oralnu suspenziju.
Iron oxide black (E172) Propylene glycol Isopropyl alcohol Hypromellose (E464)
željezov oksid, crni (E172) propilenglikol izopropilni alkohol hipromeloza (E464)
Frequency is not known.
Učestalost je nepoznata.
Proper swallowing ability should be carefully monitored in patients with co-morbid conditions.
Sposobnost normalnog gutanja mora se pomno pratiti u bolesnika s popratnim bolestima.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 180 TABLETS WITHOUT OUTER CARTON
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA - BOČICA SA 180 TABLETA (BEZ VANJSKE KUTIJE)
Packs of 1 bottle of 30 tablets or bottles of 180 tablets without outer carton.
Pakiranje od 1 bočice s 30 tableta ili bočice sa 180 tableta, bez vanjske kutije.
It may harm them, even if their signs of illness are the same as yours.
- puknuće stijenke crijeva (znakovi uključuju: jaku bol u trbuhu, zimicu, vrućicu, mučninu, povraćanje i osjetljivost trbuha) je prijavljeno.
Preparation using a dosing spoon:
Priprema uporabom dozirne žličice
The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of combination and after its withdrawal.
Ne može se isključiti mogućnost interakcije te treba razmotriti pozorno praćenje koncentracija ciklosporina, mofetilmikofenolata i takrolimusa u krvi tijekom i nakon kombinirane primjene s lijekom Sevelamer carbonate Winthrop.
Intestinal obstruction, Ileus/subileus, Intestinal perforation1, Gastrointestinal hemorrhage1, Intestinal ulceration1, Gastrointestinal necrosis1, Colitis1, Intestinal mass1
Poremećaji probavnog sustava mučnina, povraćanje, bol u gornjem dijelu abdomena, konstipacija proljev, dispepsija, flatulencija, bol u abdomenu opstrukcija crijeva, ileus/subileus, perforacija crijeva1, gastrointestinalna hemoragija1, ulceracija crijeva1, gastrointestinalna nekroza1, kolitis1, masa u crijevima1
Sevelamer carbonate Winthrop must be taken three times per day with meals or snacks.
Sevelemer carbonate Winthrop se mora uzimati tri puta dnevno s obrocima ili međuobrocima.
EU/1/14/952/001 180 film-coated tablets
EU/1/14/952/001 180 filmom obloženih tableta
Each film-coated tablet contains 800 mg of sevelamer carbonate.
Jedna filmom obložena tableta sadrži 800 mg sevelamerkarbonata.
In this case the 0.4 g dose of Sevelamer Carbonate Winthrop powder must be measured using the dosing spoon provided in the carton.
U tom slučaju doza od 0,4 g Sevelamer carbonate Winthrop praška mora se odmjeriti uporabom dozirne žličice koja je priložena u kutiji.
• Hypophosphataemia.
• Hipofosfatemija
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in paediatric patients (>6 years of age and a body surface area (BSA) of >0.75 m2) with chronic kidney disease.
Sevelamer carbonate Winthrop je indiciran za kontrolu hiperfosfatemije u pedijatrijskih bolesnika (>6 godina starosti i površine tijela >0,75 m2) s kroničkom bubrežnom bolesti.
HDPE bottles with a child resistant polypropylene closure and a foil induction seal.
HDPE bočice s polipropilenskim sigurnosnim zatvaračem za djecu i zalijepljenom zaštitnom folijom.
The phosphate serum level should be monitored and the sevelamer carbonate dosage adjusted consequently.
Potrebno je pratiti razinu fosfata u serumu i posljedično prilagoditi dozu sevelamerkarbonata.
60 sachets per carton 90 sachets per carton
60 vrećica u kutiji 90 vrećica u kutiji
If you take more Sevelamer carbonate Winthrop than you should
Ako uzmete više lijeka Sevelamer carbonate Winthrop nego što ste trebali
• have disturbed level of bicarbonate in your blood and increased acidity in the blood and other body tissue.
• imati poremećenu razinu bikarbonata u krvi te povišenu kiselost u krvi i drugih tjelesnih tkiva.
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).
9 g/kg/dan) i štakorima (0,3, 1 ili 3 g/kg/dan).
Patients taking sevelamer carbonate should adhere to their prescribed diets.
Bolesnici koji uzimaju sevelamerkarbonat moraju se pridržavati propisanog načina prehrane.
(Instructions for presentation with dosing spoon) The sachet has to be discarded after 24 hours of opening
(Upute za pakiranje sa dozirnom žličicom) Vrećica se mora baciti nakon 24 sata od otvaranja.
The anti-arrhythmic medical product should be taken at least one hour before or three hours after Sevelamer carbonate Winthrop, and blood monitoring can be considered.
Lijekove protiv aritmije potrebno je uzeti barem jedan sat prije ili tri sata nakon uzimanja lijeka Sevelemar carbonate Winthrop te se može razmotriti praćenje koncentracije u krvi.
Other medicines and Sevelamer carbonate Winthrop
Drugi lijekovi i Sevelamer carbonate Winthrop
Crystal deposit intestine1
Pretrage kristalne naslage u crijevu1
Patients taking Sevelamer carbonate Winthrop should adhere to their prescribed diets.
Bolesnici koji uzimaju Sevelamer carbonate Winthrop moraju se pridržavati propisanog načina prehrane.
The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level.
Početna doza Preporučena početna doza sevelamerkarbonata je 2,4 g ili 4,8 g na dan, ovisno o kliničkim potrebama i razini fosfora u serumu.
Sevelamer carbonate Winthrop must be taken three times per day with meals.
Sevelamer carbonate Winthrop mora se uzimati triput na dan uz obrok.
EU/1/14/952/004 30 film-coated tablets
EU/1/14/952/004 30 filmom obloženih tableta
• cases of itching,
• slučajevi svrbeža,
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 reaction.
Sevelamerklorid, koji sadrži istu djelatnu tvar kao sevelamerkarbonat, bio je davan zdravim dobrovoljcima u dozama do 14 grama na dan tijekom osam dana bez razvoja nuspojava.
To achieve the correct dose when the sachet has to be divided, please use the dedicated presentation of 0.8 g powder with dosing spoon.
Kako bi se postigla ispravna doza kada se vrećica s praškom mora podijeliti, koristiti za to predviđeno pakiranje s vrećicama od 0,8 g praška s priloženom dozirnom žličicom.
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Sevelamer carbonate Winthrop je indiciran za kontrolu hiperfosfatemije u odraslih bolesnika koji su na hemodijalizi ili peritonejskoj dijalizi.
The study met its primary endpoint, meaning sevelamer carbonate reduced serum phosphorus by an LS mean difference of 0.90 mg/dL compared to placebo, and secondary efficacy endpoints.
Ispitivanje je postiglo mjeru primarnog ishoda, što znači da je sevelamerkarbonat smanjio razinu fosfora u serumu za srednju vrijednost (dobivenu metodom najmanjih kvadrata) razlike od 0,90mg/dL u usporedbi s placebom, i mjere sekundarnih ishoda djelotvornosti.
Each carton contains 90 sachets and a dosing spoon to measure the 0.4 g dose of powder.
(Upute za pakiranje sa dozirnom žličicom) Jedna kutija sadrži 90 vrećica i dozirnu žličicu za odmjeravanje doze od 0,4 g praška.
Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop Sevelamer carbonate Winthrop treatment.
Obratite se svom liječniku koji će odlučiti možete li dojiti svoje dijete ili ne, te da li je potrebno prekinuti liječenje lijekom Sevelamer carbonate Winthrop..
OTHER SPECIAL WARNING, IF NECESSARY EXPIRY DATE
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO ROK VALJANOSTI
Difficulties swallowing the Sevelamer carbonate Winthrop tablet have been reported.
Prijavljene su poteškoće s gutanjem Sevelamer carbonate Winthrop tableta.
It is recommended that CKD patients not on dialysis are given vitamin D supplements (approximately 400 IU of native vitamin D daily) which can be part of a multivitamin preparation to be taken apart from their dose of sevelamer carbonate.
(približno 400 IU nativnog vitamina D dnevno), koji mogu biti dio multivitaminskog pripravka koji se mora uzimati odvojeno od doze sevelamerkarbonata.
This medicine does not require any special temperature storage conditions.
Lijek ne zahtijeva posebne temperaturne uvjete čuvanja.
What you need to know before you take Sevelamer carbonate Winthrop 3.
Što morate znati prije nego što počnete uzimati Sevelamer carbonate Winthrop
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.
Sevelamerklorid, koji sadrži istu djelatnu tvar kao sevelamerkarbonat, bio je davan zdravim dobrovoljcima u dozama do 14 grama na dan tijekom osam dana, bez razvoja nuspojava.
In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
U 12-tjednom ispitivanju koje je uključivalo bolesnike na peritonejskoj dijalizi, uočena su slična smanjenja vrijednosti iPTH-a kao u bolesnika koji su primali kalcijev acetat.
Stopping Sevelamer carbonate Winthrop would lead to important consequences such as calcification in the blood vessels.
Prekid uzimanja lijeka Sevelamer carbonate Winthrop bi dovest će do ozbiljnih posljedica kao što je otvrdnuće krvnih žila.
The powder may also be pre-mixed with cold beverage or unheated food (see 4.2).
Prašak se također prethodno može pomiješati s hladnim pićem ili hranom koja nije zagrijana (vidjeti
A 0,4 g dosing spoon is provided in the carton.
Dozirna žličica za odmjeravanje 0,4 g je priložena u kutiji.
Sevelamer carbonate Winthrop film-coated tablets are white to off-white tablets with SC800 imprinted on one side.
Sevelamer carbonate Winthrop filmom obložene tablete su bijele tablete, s otisnutom oznakom SC800
Caution should be exercised when prescribing PPI to patients concomitantly treated with Sevelamer carbonate Winthrop.
Potreban je oprez pri propisivanju inhibitora protonske pumpe bolesnicima koji su istovremeno liječeni lijekom Sevelamer carbonate Winthrop.
• if you experience severe abdominal pain, stomach or intestine disorders, or blood in the stool (gastrointestinal bleeding).
• osjetite jaku bol u trbuhu, poremećaje želuca ili crijeva ili krv u stolici (gastrointestinalno krvarenje).
• if you have active inflammation of the bowel
• imate aktivnu upalu crijeva
Children and adolescents (>6 years of age and a BSA of >0.75m2) For paediatric patients, serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated in increments based on patient's BSA, three times per day every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Djeca i adolescenti (>6 godina starosti i površine tijela >0,75 m2) Za pedijatrijske bolesnike, razine fosfora u serumu moraju se pratiti i doza sevelamerkarbonata titrirati u koracima temeljenim na bolesnikovoj površini tijela, tri puta dnevno svaka 2 do 4 tjedna dok se ne postigne prihvatljiva razina fosfora u serumu, s redovitim praćenjem nakon toga.
In patients not taking supplemental folic acid but on sevelamer, folate level should be assessed regularly.
Ako bolesnici ne uzimaju nadomjestke folatne kiseline, a liječe se sevelamerom, potrebno je redovno pratiti razinu folata.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - SACHETS
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA - VREĆICE
The safety and efficacy of Sevelamer carbonate Winthrop in children below the age of 6 years or in children with a BSA (Body Surface Area) below 0.75 m2 have not been established.
Sigurnost i djelotvornost lijeka Sevelamer carbonate Winthrop u djece mlađe od 6 godina ili u djece s površinom tijela ispod 0,75 m2 nisu ustanovljene.
- Serious inflammation of the large bowel (symptoms include: severe abdominal pain, stomach or intestine disorders, or blood in the stool [gastrointestinal bleeding]) and crystal deposit in the intestine have been reported.
- ozbiljna upala debelog crijeva (simptomi uključuju: jaku bol u trbuhu, poremećaje želuca ili crijeva ili krv u stolici [krvarenje u crijevima]) te nakupljanje kristala u crijevima su prijavljeni.
Each tablet contains 800 mg sevelamer carbonate.
Jedna tableta sadrži 800 mg sevelamerkarbonata.
Sevelamer carbonate Winthrop contains the active substance sevelamer carbonate.
Sevelamer carbonate Winthrop sadrži djelatnu tvar sevelamerkarbonat.
There was no increased incidence of tumors observed in mice (human equivalent dose 3 times the maximum clinical trial dose).
Nije uočena povećana incidencija tumora kod miševa (pri dozi koja je odgovarala trostrukoj najvišoj dozi za ljude u kliničkim ispitivanjima).
EU/1/14/952/002 60 sachets EU/1/14/952/003 90 sachets
EU/1/14/952/002 60 vrećica EU/1/14/952/003 90 vrećica
The safety and efficacy of sevelamer carbonate have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l.
Nisu ustanovljene sigurnost i djelotvornost sevelamerkarbonata u odraslih bolesnika s kroničnom bubrežnom bolešću koji nisu na dijalizi, a koji imaju razinu fosfora u serumu < 1,78 mmol/l.
Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
Zentiva Pharma GmbH Tel: +49 (0)180 2 222010
Sevelamer carbonate Winthrop 800 mg film-coated tablets
Sevelamer carbonate Winthrop 800 mg filmom obložene tablete
Talk to your doctor who will decide if you can continue the treatment with Sevelamer carbonate Winthrop.
Obratite se svom liječniku koji će odlučiti hoćete li nastaviti liječenje lijekom Sevelamer carbonate Winthrop.
Dialysis
Dojenje
The treatment response during the 2-week FDP was not affected by BSA, in contrast however, no treatment response was observed in pediatric patients with qualifying phosphorus levels <7.0 mg/dL.
Površina tijela nije utjecala na odgovor na liječenje tijekom 2 tjedna razdoblja fiksne doze, te je nasuprot tome, izostanak odgovora na liječenje zabilježen u pedijatrijskih bolesnika s početnom vrijednosti fosfora <7,0 mg/dL.
If you forget to take Sevelamer carbonate Winthrop
Ako ste zaboravili uzeti Sevelamer carbonate Winthrop
27% of paediatric patients reached their age appropriate serum phosphorus level at end of treatment.
pedijatrijskih bolesnika dostiglo je razinu fosfora u serumu prikladnu za dob.
Sevelamer carbonate Winthrop contains sevelamer, a non-absorbed phosphate binding crosslinked polymer.
Sevelamer carbonate Winthrop sadrži sevelamer, neapsorbirajući umreženi polimer koji veže fosfate.
Your doctor will check for interactions between Sevelamer carbonate Winthrop and other medicines on a regular basis.
Liječnik će redovito provjeravati jesu li nastupile interakcije između lijeka Sevelamer carbonate
In two randomised, cross over clinical trials, sevelamer carbonate has been shown to be therapeutically equivalent to sevelamer hydrochloride and therefore effective in controlling serum phosphorus in CKD patients on haemodialysis.
U dva randomizirana ukrižena klinička ispitivanja dokazano je da je sevelamerkarbonat terapijski ekvivalentan sevelamerkloridu, što znači da učinkovito kontrolira koncentracije fosfora u serumu u bolesnika s kroničnom bubrežnom bolešću koji su na hemodijalizi.
For a 2.4 g dose, the powder for oral suspension should be dispersed in 60 ml of water per sachet.
Doza od 2,4 g praška za oralnu suspenziju iz jedne vrećice se prije primjene mora rastopiti u 60 ml vode.
If you stop taking Sevelamer carbonate Winthrop
Ako prestanete uzimati Sevelamer carbonate Winthrop
• adult patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/l.
• odraslih bolesnika s kroničnom (dugotrajnom) bubrežnom bolešću koji nisu na dijalizi i imaju razinu fosfora u serumu (krvi) jednaku ili višu od 1,78 mmol/l.
90 sachets per carton
90 vrećica u kutiji
• Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treat low thyroid hormone levels) and Sevelamer carbonate Winthrop.
• U nekih osoba koje uzimaju levotiroksin (koji se koristi za liječenje niskih razina hormona štitnjače) i Sevelamer carbonate Winthrop manje često može doći do nedostatka hormona štitnjače.
Talk to your doctor while taking Sevelamer carbonate Winthrop:
Obratite se svom liječniku ako tijekom uzimanja Sevelamer carbonate Winthrop:
Package leaflet: Information for the user Sevelamer carbonate Winthrop 800 mg film-coated tablets sevelamer carbonate
Uputa o lijeku: Informacije za korisnika Sevelamer carbonate Winthrop 800 mg filmom obložene tablete sevelamerkarbonat
The first study demonstrated that sevelamer carbonate tablets dosed three times per day was equivalent to sevelamer hydrochloride tablets dosed three times per day in 79 haemodialysis patients treated over two randomised 8 week treatment periods (mean serum phosphorus time-weighted averages were 1.5 ± 0.3 mmol/L for both sevelamer carbonate and sevelamer hydrochloride).
U prvom je ispitivanju dokazano da je primjena tableta sevelamerkarbonata tri puta na dan bila jednako učinkovita kao primjena tableta sevelamerklorida tri puta na dan u 79 bolesnika na hemodijalizi liječenih tijekom dva nasumična 8-tjedna razdoblja liječenja (prosjek srednjih vrijednosti serumskog fosfora, uzimajući u obzir vrijeme liječenja, bio je 1,5 ± 0,3 mmol/l i kod primjene sevelamerkarbonata i kod primjene sevelamerklorida).
• patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/L.
• bolesnika s kroničnom (dugotrajnom) bubrežnom bolešću koji nisu na dijalizi i imaju razinu fosfora u serumu (krvi) jednaku ili višu od 1,78 mmol/l.
Check with your doctor, pharmacist or nurse if you are not sure.
Ako niste sigurni, obratite se Vašem liječniku, ljekarniku ili medicinskoj sestri.
Sevelamer carbonate Winthrop 800 mg film-coated tablets sevelamer carbonate
Sevelamer carbonate Winthrop 800 mg filmom obložene tablete sevelamerkarbonat
Sevelamer carbonate treatment should be reevaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Liječenje sevelamerkarbonatom treba se ponovo procijeniti u bolesnika koji razviju tešku konstipaciju ili druge teške gastrointestinalne simptome.
• if you have bowel obstruction
• ako patite od blokade crijeva
(Instructions for presentation WITH dosing spoon) To achieve the correct dose, the dosing spoon provided in the carton must be used to measure 0.4 g of Sevelamer carbonate Winthrop.
Kako bi se postigla ispravna doza mora se upotrijebiti dozirna žličica koja je priložena u kutiji kako bi se izmjerilo 0,4 g Sevelamer carbonate Winthrop praška.