natgillin/translations-raw huggingface dataset:
The binding sites become partially protonated in the stomach and interact through ionic and hydrogen bonding with both dietary phosphate anions and bile acids in the duodenum.
U želucu vezna mjesta postaju djelomično protonirana i pomoću ionskih i vodikovih veza reagiraju s fosfatnim anionima iz hrane i žučnim kiselinama u duodenumu.
BindRen is not absorbed from the gastrointestinal tract of healthy volunteers following oral administration of 14C-radiolabelled colestilan.
BindRen se ne apsorbira iz probavnog trakta zdravih dobrovoljaca nakon peroralne primjene kolestirana označenog izotopom 14C.
White, oval shaped, film-coated tablet approximately 20.2 mm in length and 10.7 mm wide printed with “BINDREN” (in blue ink) on one side.
Bijela, ovalna filmom obložena tableta duljine približno 20,2 mm i širine 10,7 mm, s otisnutim “BINDREN” (plavom tintom) na jednoj strani.
Colestilan also showed significant reductions from baseline by 35.3 and 30.1% at week 12 in two flexible-dose studies, and by 25.8% after one year in long-term studies.
Kolestilan je također pokazao značajno sniženje u odnosu na početnu vrijednost za 35,3 i 30,1% u 12. tjednu u dva ispitivanja s fleksibilnom dozom te za 25,8% nakon jedne godine u dugotrajnim ispitivanjima.
If you have to take other medicines your doctor will tell you if you can take the other medicines at the same time as BindRen or if you need to take the other medicines 1 hour before or 3 hours after taking BindRen.
Ako morate uzimati druge lijekove, liječnik će Vas obavijestiti možete li uzimati te druge lijekove istovremeno s BindRenom ili trebate uzimati te druge lijekove 1 sat prije ili 3 sata poslije uzimanja BindRena.
Allergic dermatitis, guttae psoriasis
alergijski dermatitis, kapljičasta psorijaza
Fertility No data are available to assess the potential influence of BindRen on fertility.
Nema dostupnih podataka da bi se mogao procijeniti mogući utjecaj BindRena na plodnost.
Folate deficiency
Manjak folata
The most serious side effects are bleeding from the stomach or lower bowel (uncommon).
Najozbiljnije nuspojave su krvarenje iz želuca ili debelog crijeva (manje često).
If you forget to take BindRen
Ako ste zaboravili uzeti BindRen
Serum glycosylated haemoglobin A1c
Glikozilirani hemoglobin A1c u serumu
Due to the high in vitro binding potential between BindRen and levothyroxine, closer monitoring of thyroid stimulating hormone (TSH) levels in patients receiving BindRen and levothyroxine is recommended.
Zbog velikog potencijala vezanja in vitro između BindRena i levotiroksina, preporučuje se pažljivije praćenje razine tireotropina (TSH) u bolesnika koji primaju BindRen i levotiroksin.
If you do become pregnant or you are breast-feeding, and your doctor decides that you should continue your treatment with BindRen, your doctor may ask you to also take vitamin supplements.
Ako zatrudnite ili dojite, a Vaš liječnik odluči da trebate nastaviti s liječenjem BindRenom, liječnik će Vam možda preporučiti uzimanje vitaminskih nadomjestaka.
Concomitant treatment with medicinal products with a narrow therapeutic window requires close monitoring of drug concentrations or adverse reactions, on initiation or dose-adjustment of either BindRen or the concomitant medicinal product.
Istovremeno liječenje lijekovima s uskim terapijskim rasponom zahtijeva pažljivo praćenje koncentracija lijeka ili nuspojava na početku liječenja ili prilikom prilagodbe doze bilo BindRena bilo istovremeno primjenjivanog lijeka.
If an acceptable serum phosphorus concentration is not achieved, the dose may be increased by 3 g per day (1 g three times daily) in 2-3 weekly intervals.
Ako se ne postigne zadovoljavajuća koncentracija fosfora u serumu, doza se može povisivati za 3 g na dan (1 g tri puta na dan) u vremenskim razmacima od 23 tjedna.
The most serious adverse reactions were gastrointestinal haemorrhage (uncommon) and constipation (common).
Najozbiljnije nuspojave bile su gastrointestinalno krvarenje (manje često) i konstipacija (često).
Pack sizes: 30, 60 or 90 sachets per carton.
30, 60 ili 90 vrećica po kutiji.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet allphamed PHARBIL Arzneimittel GmbH Hildebrandstr. 12
The most frequently reported adverse reactions were nausea, dyspepsia and vomiting (all common).
Najčešće zabilježene nuspojave bile su mučnina, dispepsija i povraćanje (sve česte).
Patients with seizure disorders were excluded from clinical trials with BindRen.
Bolesnici s epileptičkim poremećajima bili su isključeni iz kliničkih ispitivanja BindRena.
Colestilan significantly reduced serum LDL-cholesterol by 17.8, 25.6, 29.4, 34.8 and 33.4% at 3, 6, 9, 12 and 15 g/day at week 12 compared to placebo in fixed-dose study, respectively.
Kolestilan je značajno smanjio LDL-kolesterol u serumu za 17,8, 25,6, 29,4, 34,8 odnosno 33,4% u dozi od 3, 6, 9, 12 i 15 g na dan u 12. tjednu u usporedbi s placebom u ispitivanju s fiksnom dozom.
Close monitoring of patients with hypothyroidism is recommended when levothyroxine is co-administered with BindRen (see section 4.5).
Preporučuje se pažljivo pratiti bolesnike s hipotireoidizmom kad se levotiroksin primjenjuje istovremeno s BindRenom (vidjeti dio 4.5).
By binding phosphate from food in the digestive tract, colestilan lowers the serum phosphorus concentration.
Time što veže fosfate iz hrane u probavnom traktu, kolestilan snižava koncentraciju fosfora u serumu.
Tremor, dizziness, headache, dysgeusia
tremor, omaglica, glavobolja, disgeuzija
Patients previously on other phosphate binders who are switched to BindRen should start taking 6-9 g per day (2-3 g three times daily).
Bolesnici koji su prethodno uzimali druge lijekove koji vežu fosfate i sad se prebacuju na BindRen trebaju započeti liječenje dozom od 6-9 g na dan (2-3 g tri puta na dan).
BindRen is for oral use.
BindRen je namijenjen za peroralnu primjenu.
The recommended starting dose is 6-9 g per day taken as 2 g or 3 g three times per day with meals.
Preporučena početna doza je 6-9 g na dan koja se uzima kao 2 g ili 3 g tri puta na dan uz obrok.
How BindRen works
Kako BindRen djeluje
A majority of patients received 12 or 15 g/day of colestilan in the long-term studies.
Većina bolesnika u ovim dugotrajnim ispitivanjima primala je 12 ili 15 g kolestilana na dan.
How to take BindRen
Kako uzimati BindRen
Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia.
Hipokalcemija/hiperkalcemija Bolesnici s bubrežnom insuficijencijom mogu razviti hipokalcemiju ili hiperkalcemiju.
(≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
<1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000) i nepoznato
Fax: +49 211 - 520 544 99
Tel: +49 211 - 520 544 33 Fax: +49 211 - 520 544 99
In a double-blind, 12-week fixed-dose study with five colestilan groups (3, 6, 9, 12 and 15 g/day) and placebo, colestilan at 6 g/day and above demonstrated a dose-dependent reduction in serum phosphorus level.
U dvostruko slijepom ispitivanju fiksne doze u trajanju od 12 tjedana s pet skupina koje su primale kolestilan (3, 6, 9, 12 i 15 g na dan) i placebo, pokazalo se da kolestilan u dozi od 6 g na dan i višoj smanjuje razine fosfora u serumu ovisno o dozi.
BindRen does not contain calcium, and has no effect on serum calcium concentrations on treatment for up to one year.
BindRen ne sadrži kalcij i nema učinka na koncentracije kalcija u serumu tijekom liječenja u trajanju do godinu dana.
Patients who are constipated should be monitored carefully while being treated with BindRen.
Bolesnike s konstipacijom treba pažljivo nadzirati za vrijeme liječenja BindRenom.
Folate deficiency, hypertriglyceridaemia, polydipsia
manjak folata, hipertrigliceridemija, polidipsija
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava (vidjeti ispod).
Do not use this medicine after the expiry date stated on the box, the bottle label or the blister after the abbreviation “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, naljepnici bočice ili blisteru iza „Rok valjanosti”.
However, BindRen did not induce any clinically relevant change in chloride and bicarbonate on treatment for up to one year.
Međutim, BindRen nije izazvao nikakvu klinički važnu promjenu klorida i bikarbonata tijekom liječenja u trajanju do godinu dana.
Patients with severe hepatic impairment were excluded from clinical studies.
Bolesnici s teškim oštećenjem funkcije jetre bili su isključeni iz kliničkih ispitivanja.
Colestilan also binds bile acids, thereby lowering the serum LDL-cholesterol concentration.
Kolestilan također veže žučne kiseline te tako snižava koncentraciju LDL-kolesterola u serumu.
Serum phosphorus concentrations should be monitored.
Potrebno je pratiti koncentracije fosfora u serumu.
What you need to know before you take BindRen Do not take BindRen - if you are allergic to colestilan or any of the other ingredients of this medicine (listed in section 6) - if you have bowel obstruction (a blockage of your intestines)
Nemojte uzimati BindRen - ako ste alergični na kolestilan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
Vitamin K deficiency, calciphylaxis, electrolyte imbalance, fluid overload
manjak vitamina K, kalcifilaksija, poremećaj elektrolita, preopterećenje tekućinom
Insomnia
nesanica
Colestilan is a non-absorbed, non-calcium, non-metallic phosphate-binding polymer.
Kolestilan je nemetalni polimer koji veže fosfate, ne apsorbira se i ne sadrži kalcij.
Caution should be exercised when prescribing BindRen to patients also taking anti-seizure medicinal products.
Potreban je oprez kad se BindRen propisuje bolesnicima koji također uzimaju antiepileptike.
• Severe hepatic impairment (see also section 4.2)
• teško oštećenje funkcije jetre (vidjeti također dio 4.2) • epileptički napadaji
High density polyethylene (HDPE) bottles, with a polypropylene cap and an induction seal.
Boce od polietilena visoke gustoće (HDPE), s polipropilenskim zatvaračem i zaštitnom folijom.
Caution should be exercised when prescribing BindRen to patients receiving immunosuppressants.
Potreban je oprez kad se BindRen propisuje bolesnicima koji primaju imunosupresive.
Your doctor may consider measuring blood levels of the other medicines you are taking.
Liječnik može razmotriti i potrebu određivanja razine drugih lijekova u krvi.
Gastrointestinal haemorrhage
Gastrointestinalno krvarenje
Tabulated list of adverse reactions A tabulated list of frequencies was defined using the following convention: very common (≥1/10); common
Tablični popis učestalosti definiran je pomoću sljedećih kategorija: vrlo često (≥1/10); često (≥1/100 i
Uncommon (may affect up to 1 in 100 people) side effects: low blood pressure, weakness, thirst, headache, dizziness, shaking, dry mouth, swallowing difficulties, change in taste sensation, heartburn, hardening of the stool, inflammation or pain of the stomach or bowel, change in bowel habit, sleeplessness, itching, dry skin, rash, hives, itching red spots, collection of blood (haematoma) e.g. under the skin, joint pain, back pain, pain in limbs, muscle pain or spasms, increased blood levels of parathyroid hormone (a protein), certain blood fats and liver enzymes and a low level of folate (a vitamin).
Manje česte (mogu se javiti u manje od 1 na 100 osoba) nuspojave: niski krvni tlak, slabost, žeđ, glavobolja, omaglica, drhtanje, suha usta, poteškoće pri gutanju, promjene osjeta okusa, žgaravica, tvrda stolica, upala ili bol u želucu ili crijevima, promjena crijevnih navika, nesanica, svrbež, suha koža, osip, koprivnjača, crvene točke koje svrbe, nakupine krvi (hematomi) npr. ispod kože, bol u zglobovima, bol u leđima, bol u udovima, mišićni bol ili grčevi, povišene razine paratiroidnog hormona (jedne bjelančevine) u krvi, određenih masnoća u krvi i enzima jetre te niska razina folata (vitamina).
13.1 g. The rate of responders (either a reduction in serum phosphorus ≤ 1.78 mmol/L and/or a reduction from baseline ≥ 0.3 mmol/L) was 50.4 % and 43.8% in the two studies, respectively (placebo 30.8% and
Brzina odgovora (smanjenje fosfora u serumu ≤ 1,78 mmol/l i/ili smanjenje u odnosu na početnu vrijednost ≥ 0,3 mmol/l) bila je 50,4 % odnosno 43,8% u ta dva ispitivanja (placebo 30,8% odnosno 26,3%).
BindRen did not induce a clinically relevant reduction in folate absorption during clinical studies of up to one year.
BindRen nije izazvao klinički značajno smanjenje apsorpcije folata tijekom kliničkih ispitivanja u trajanju do godinu dana.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE
After one year, the mean serum phosphorus level was 1.89 mmol/L with a significant reduction from baseline of 0.39 mmol/L and responder rate (phosphorus level <1.78 mmol/L) was 44%.
Nakon jedne godine, srednja vrijednost fosfora u serumu bila je 1,89 mmol/l uz značajno sniženje u odnosu na početnu vrijednost za 0,39 mmol/l, a brzina odgovora (razina fosfora <1,78 mmol/l) bila je 44%.
Serum cholesterol
Kolesterol u serumu
INFORMATION IN BRAILLE BindRen 1 g tablets
16. PODACI NA BRAILLEOVOM PISMU BindRen 1 g tablete
• Serum albumin <30 g/L
• nedavni peritonitis kod bolesnika na peritonejskoj dijalizi • serumski albumin <30 g/l
Serum calcium In clinical studies, colestilan had no effect on serum calcium levels over a period of up to one year.
U kliničkim ispitivanjima, kolestilan nije imao učinka na razine kalcija u serumu u razdoblju do godinu dana.
BindRen is indicated for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
BindRen je indiciran za liječenje hiperfosfatemije u odraslih bolesnika u 5. stadiju kroničnog bubrežnog zatajenja (KBZ) koji se liječe hemodijalizom ili peritonejskom dijalizom.
In subjects with baseline HbA1c ≥7.0%, colestilan showed a reduction of between 0.36 to 1.38% at week 12 in the fixed-dose study, and by 0.94 and 0.91% at week 12 in the two flexible-dose studies.
U ispitanika s početnim HbA1c ≥7,0%, kolestilan je pokazao smanjenje za 0,36 do 1,38% u 12. tjednu u ispitivanju s fiksnom dozom te za 0,94 odosno 0,91% u 12. tjednu u dva ispitivanja s fleksibilnom dozom.
Acetic acid esters of mono- and diglycerides of fatty acids Polysorbate 80
Film ovojnica hipromeloza esteri acetatne kiseline i mono- i diglicerida masnih kiselina polisorbat 80
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 3 G GRANULES IN SACHETS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA - 3 G GRANULE U VREĆICAMA
Patients should be encouraged to adhere to their prescribed low phosphate diets.
Bolesnike treba poticati da se pridržavaju propisane dijete s niskim sadržajem fosfata.
BindRen contains the active substance colestilan.
BindRen sadrži djelatnu tvar kolestilan.
The Phase II and III clinical studies involving 1,410 patients with CKD Stage 5 on dialysis treated with BindRen for up to one year constituted the safety population.
U kliničkim ispitivanjima faze II i III, sigurnost lijeka ispitana je na populaciji od 1410 bolesnika u 5. stadiju KBZ-a na dijalizi liječenih BindRenom u trajanju do godinu dana.
The colestilan-bound phosphorus is then excreted from your body in faeces.
Fosfor vezan za kolestilan se potom izlučuje iz Vašeg tijela stolicom.
The other ingredients are purified water, hydroxypropylcellulose, colloidal, anhydrous silica, hydrogenated castor oil, hypromellose, acetic acid esters of mono- and diglycerides of fatty acids, polysorbate 80, shellac, indigo carmine aluminium lake (E132) and carnauba wax.
Drugi sastojci su pročišćena voda, hidroksipropilceluloza, koloidni, bezvodni silicijev dioksid, hidrogenirano ricinusovo ulje, hipromeloza, esteri acetatne kiseline i mono- i diglicerida masnih kiselina, polisorbat 80, šelak, indigo carmine aluminium lake (E132) i karnauba vosak.
Muscle spasm, musculoskeletal pain, arthralgia, back pain, pain in extremities
spazmi mišića, mišićno-koštani bol, artralgije, bol u leđima, bol u ekstremitetima
This includes medicines for irregular heart rhythm (such as digoxin), for treating high blood pressure (such as enalapril maleate), anti-seizure medicines (such as valproic acid, phenytoin, carbamazepine, lamotrigine, oxcarbazepine, topiramate, gabapentin, vigabatrin, zonisamide and levetiracetam), levothyroxine (used to treat thyroid hormone deficiency), oral birth control medicines (oestrogen, progestogen or combination pills), immune system suppressing medicines (such as cyclosporine, mycophenolate mofetil, tacrolimus).
To uključuje lijekove za nepravilan srčani ritam (kao što je digoksin), za liječenje povišenog krvnog tlaka (kao što je enalapril maleat), antiepilepsijske lijekove (kao što su valproična kiselina, fenitoin, karbamazepin, lamotrigin, okskarbazepin, topiramat, gabapentin, vigabatrin, zonisamid i levetiracetam),
Patients that become pregnant and where a benefit/risk assessment confirms continued treatment with BindRen, supplementation of vitamins may be required, see section 4.4.
Bolesnicama koje zatrudne i kod kojih procjena omjera koristi i rizika potvrđuje korist od nastavka liječenja BindRenom može biti potrebna nadoknada vitamina, vidjeti dio 4.4.
Bottles
Boce
Changes in the bile acid pool in the gastrointestinal tract have also been observed to lower serum glucose.
Također je opaženo da promjene u količini žučnih kiselina u probavnom traktu snižavaju glukozu u serumu.
Hypothyroidism
Hipotireoidizam
BindRen granules are white cylindrical granules.
Kako BindRen izgleda i sadržaj pakovanja BindRen granule bijele, cilindrične granule.
The safety and efficacy of BindRen has not been studied in patients with:
4.4 Posebna upozorenja i mjere opreza pri uporabi Sigurnost i djelotvornost BindRena nije ispitana u bolesnika s:
Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence, abdominal discomfort
konstipacija, abdominalni bol, povraćanje, distenzija abdomena, mučnina, gastritis, dispepsija, proljev, flatulencija, abdominalna nelagoda
Granules.
Granule.
Colestilan may also bind uric acid in the gastrointestinal tract.
Kolestilan može vezati mokraćnu kiselinu u probavnom sustavu.
The other ingredients are: purified water, hydroxypropylcellulose, colloidal, anhydrous silica, hydrogenated castor oil, ethylcellulose, hypromellose, macrogol 8000, triethyl citrate, titanium dioxide, talc, cetanol and sodium laurilsulfate.
Drugi sastojci su pročišćena voda, hidroksipropilceluloza, koloidni, bezvodni silicijev dioksid, hidrogenirano ricinusovo ulje, etilceluloza, hipromeloza, makrogol 8000, trietilcitrat, titanijev dioksid, talk, cetanol i natrijev laurilsulfat.
Talk to your doctor or pharmacist if during your treatment with BindRen, any of the following applies to you: - you experience constipation, since your doctor may wish to monitor your bowel function to detect potential side effects (see section 4).
Obratite se svom liječniku ili ljekarniku ako tijekom liječenja BindRenom nešto od slijedećeg vrijedi za Vas: - imate zatvor, liječnik će možda htjeti pratiti funkciju Vaših crijeva kako bi prepoznao moguće nuspojave (vidjeti dio 4). - rečeno Vam je da imate poremećaj zbog kojeg je smanjena sposobnost crijeva da apsorbiraju hranjive sastojke (malapsorpcijski sindrom) ili ako se liječite takozvanim kumarinskim antikoagulansima (npr.
Calcium-phosphorus ion product was reduced by at least 0.48 mmol2/L2 at week 12 compared to placebo at doses ≥9 g/day in fixed-dose study and by 1.05 and 0.86 mmol2/L2 at week 12 in two flexible-dose studies.
Umnožak kalcija i fosfora u serumu bio je smanjen za najmanje 0,48 mmol2/l2 u 12. tjednu u usporedbi s placebom u dozama od ≥9 g na dan u ispitivanju s fiksnom dozom i za 1,05 odnosno 0,86 mmol2/l2 u 12. tjednu u dva ispitivanja s fleksibilnom dozom.
Patients that breast-feed and where a benefit/risk assessment confirms continued treatment with BindRen, supplementation of vitamins may be required, see section 4.4.
Bolesnicama koji doje i kod kojih procjena omjera koristi i rizika potvrđuje korist od nastavka liječenja BindRenom može biti potrebna nadoknada vitamina, vidjeti dio 4.4.
BindRen 1 g film-coated tablets colestilan
BindRen 1 g filmom obložene tablete kolestilan
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 g colestilan.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 1 g kolestilana.
No data on the use of BindRen in pre-dialysis patients are available.
Nema dostupnih podataka o primjeni BindRena u bolesnika koji još nisu na dijalizi.
In these patients, monitoring of vitamin A, D and E concentrations or assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.
Kod tih se bolesnika preporučuje pratiti koncentracije vitamina A, D i E ili procijeniti status vitamina
Serum parathyroid hormone (PTH)
Paratiroidni hormon (PTH) u serumu
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS - FILM-COATED TABLETS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI - FILMOM OBLOŽENE TABLETE
BindRen is indicated for use in patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
BindRen je indiciran za primjenu u bolesnika u 5. stadiju kroničnog bubrežnog zatajenja (KBZ) na hemodijalizi ili peritonejskoj dijalizi.
Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence,
konstipacija, abdominalni bol, povraćanje, distenzija abdomena, mučnina, gastritis, dispepsija, proljev,
However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption syndromes and patients treated with coumarin anticoagulants (e.g. warfarin).
K ili vitamina topljivih u mastima, kao što su bolesnici sa sindromima malapsorpcije i bolesnici koji se liječe kumarinskim antikoagulansima (npr. varfarinom).
What BindRen is and what it is used for What you need to know before you take BindRen How to take BindRen
Što morate znati prije nego počnete uzimati BindRen
Each film-coated tablet contains 1 g of colestilan.
Jedna filmom obložena tableta sadrži 1 g kolestilana.
Hyperparathyroidism
hiperparatireoidizam
The frequency of adverse reactions increased with dose.
Učestalost nuspojava povećavala se s dozom.
These were considered to result from a deficiency of vitamin K following a reduction in the absorption of fat-soluble vitamins (see section 4.4).
K nakon smanjenja apsorpcije vitamina topljivih u mastima (vidjeti dio 4.4).
Colestilan binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood.
Kolestilan veže fosfor iz hrane u probavnom traktu i tako sprječava apsorpciju fosfora u krv.
Do not use this medicine after the expiry date stated on the box or the sachet after the abbreviation “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili vrećici iza „Rok valjanosti”.
Fixed-dose study:
Ispitivanje fiksne doze:
Posology The recommended starting dose is 6-9 g per day (2-3 g three times daily).
Doziranje Preporučena početna doza je 6-9 g na dan (2-3 g tri puta na dan).
BindRen is not absorbed from the gastrointestinal tract but may affect the bioavailability or absorption rate of other medicinal products.
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija BindRen se ne apsorbira iz probavnog trakta, ali može utjecati na bioraspoloživost ili brzinu apsorpcije drugih lijekova.