FrancophonIA/ELRC3.0 huggingface dataset:
English: Cholestagel contains the active substance colesevelam (as hydrochloride).
Croatian: Cholestagel sadrži djelatnu tvar kolesevelam (u obliku kolesevelamklorida).
English: Marketing authorisation holder Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands
Croatian: Nositelj odobrenja za stavljanjelijeka u promet Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska
English: The incidence of intestinal obstruction is likely to be increased among patients with a history of bowel obstruction or removal.
Croatian: Vjerojatna je povećana incidencija intestinalne opstrukcije u bolesnika s crijevnom opstrukcijom ili uklanjanjem crijeva u anamnezi.
English: When a drug interaction cannot be excluded with a concomitant medicinal product for which minor variations in the therapeutic level would be clinically important, or where no clinical data are available on co-administration, Cholestagel should be administered at least four hours before or at least four hours after the concomitant medication in order to minimize the risk of reduced absorption of the concomitant medication (see section 4.5).
Croatian: Ako nije moguće isključiti interakciju s istodobno primijenjenim lijekom za koji bi male varijacije terapijskih razina bile klinički važne, ili ako ne postoje klinički podaci o istodobnoj primjeni, potrebno je Cholestagel uzimati najmanje 4 sata prije ili najmanje 4 sata nakon popratnog lijeka kako bi se što više umanjio rizik od smanjene apsorpcije popratnog lijeka (vidjeti dio 4.5).
English: Anticoagulant therapy
Croatian: Antikoagulantna terapija
English: Co-administration of colesevelam and metformin extended-release (ER) tablets increases the exposure of metformin.
Croatian: Antidijabetici Istodobna primjena kolesevelama i tableta metformina s produženim oslobađanjem povećava izloženost metformina.
English: It should be noted that stopping Cholestagel therapy will result in increased ciclosporin blood concentrations.
Croatian: Cholestagel rezultirati povišenjem koncentracije ciklosporina u krvi.
English: Patients starting on Cholestagel already taking ciclosporin should have their blood concentrations monitored prior to combination therapy and frequently monitored immediately starting co-therapy with the ciclosporin dose adjusted accordingly.
Croatian: U bolesnika koji započinju terapiju lijekom Cholestagel a već uzimaju ciklosporin, treba odrediti koncentraciju ciklosporina u krvi prije početka kombinirane terapije i često je kontrolirati neposredno nakon započinjanja kombinirane terapije te sukladno nalazima prilagođavati dozu ciklosporina.
English: - The active substance is colesevelam (as hydrochloride).
Croatian: - Djelatna tvar je kolesevelam (u obliku kolesevelamklorida).
English: Sanofi AB
Croatian: Sanofi S.p.A.
English: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Croatian: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet.
English: In general
Croatian: Općenito
English: The safety of Cholestagel has not been established in breast-feeding women.
Croatian: Sigurnost lijeka Cholestagel u dojilja nije ustanovljena.
English: How to store Cholestagel
Croatian: Kako čuvati Cholestagel
English: Do not take Cholestagel: - if you are allergic to colesevelam or to any of the other ingredients of this medicine (listed in section 6) - if you have a blockage in your intestines or bile ducts (tubes that carry bile)
Croatian: - ako ste alergični na kolesevelam ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: The recommended dose for Cholestagel, when used with a statin or ezetimibe or both together, is 4 to 6 tablets a day by mouth.
Croatian: Preporučena doza lijeka Cholestagel u kombinaciji sa statinom ili ezetimibom ili oba ova lijeka iznosi 4 do 6 tableta na dan, a uzima se kroz usta.
English: - Cholestagel may be prescribed on its own in addition to a diet low in fat and cholesterol when treatment with a statin (a class of cholesterol-lowering medicines that work in the liver) is inappropriate or not well tolerated.
Croatian: - Cholestagel se može propisati kao jedini lijek uz dijetu s niskim udjelom masti i kolesterola kada liječenje statinom (skupina lijekova za snižavanje kolesterola koji djeluje u jetri) nije primjereno ili ga bolesnik ne podnosi.
English: Package sizes are: 24 tablets (1 X 24)
Croatian: Veličine pakiranja su: 24 tablete (1 x 24) 100 tableta (2 x 50)
English: Cholestagel has not been compared directly to other bile acid sequestrants in clinical trials.
Croatian: U kliničkim ispitivanjima Cholestagel nije izravno uspoređivan s drugim sekvestrantima žučne kiseline.
English: It is important that you take glimepiride and glipizide at least 4 hours before you take Cholestagel.
Croatian: Važno je da glimepirid i glipizid uzmete najmanje 4 sata prije uzimanja lijeka Cholestagel.
English: Anticoagulant therapy should be monitored closely in patients receiving warfarin or similar agents, since bile acid sequestrants, like Cholestagel, have been shown to reduce absorption of vitamin K and therefore interfere with warfarin's anticoagulant effect.
Croatian: Antikoagulantnu terapiju treba pomno nadzirati u bolesnika koji dobivaju varfarin ili slične lijekove jer se pokazalo da sekvestranti žučne kiseline, poput lijeka Cholestagel, smanjuju apsorpciju vitamina
English: Co-administration of colesevelam and olmesartan decreases the exposure of olmesartan.
Croatian: Istodobna primjena kolesevelama i olmesartana smanjuje izloženost olmesartana.
English: Puh/Tel: + 358 (0) 201 200 300
Croatian: Sanofi Oy Puh/Tel: + 358 (0) 201 200 300
English: Patients receiving concomitant metformin ER and colesevelam should be monitored for clinical response as is usual for the use of anti-diabetes drugs.
Croatian: Kod bolesnika koji istodobno uzimaju tablete metformina s produženim oslobađanjem i kolesevelam mora se pratiti klinički odgovor kao što je uobičajeno pri primjeni antidijabetika.
English: Patients starting on ciclosporin already taking Cholestagel should have their ciclosporin blood concentrations monitored as normal and their dose adjusted as normal.
Croatian: U bolesnika koji započinju terapiju ciklosporinom a već uzimaju Cholestagel, treba na uobičajen način kontrolirati koncentraciju ciklosporina u krvi i na uobičajen način prilagođavati njegovu dozu.
English: The maximum recommended dose is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets taken once per day with a meal.
Croatian: Maksimalna preporučena doza je 6 tableta na dan, a mogu se uzeti 3 tablete dvaput na dan uz obroke ili 6 tableta jedanput na dan uz obrok.
English: Caution should be exercised when treating patients with triglyceride levels greater than 3.4 mmol/L due to the triglyceride increasing effect with Cholestagel.
Croatian: Učinci na vrijednosti triglicerida Potreban je oprez u liječenju bolesnika čije su vrijednosti triglicerida više od 3,4 mmol/l jer
English: Therefore when a drug interaction cannot be excluded with a concomitant medicinal product for which minor variations in the therapeutic level would be clinically important, Cholestagel should be administered at least four hours before or at least four hours after the concomitant medication to minimize the risk of reduced absorption of the concomitant medication.
Croatian: Stoga, ako nije moguće isključiti interakciju s istodobno primijenjenim lijekom za koji bi male varijacije terapijskih razina bile klinički važne, Cholestagel se mora uzimati najmanje 4 sata prije ili najmanje 4 sata nakon popratnog lijeka kako bi se što više umanjio rizik od smanjene apsorpcije popratnog lijeka.
English: Cholestagel tablets should be taken orally with a meal and liquid.
Croatian: Cholestagel tablete uzimaju se peroralno, uz obrok i s tekućinom.
English: Talk to your doctor or pharmacist before taking Cholestagel - if your triglyceride levels (a blood fat) are greater than 3.4 mmol/L - if you have difficulty in swallowing, or have a major stomach or intestinal disorder - if you suffer from constipation, as Cholestagel may induce or worsen this condition.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Cholestagel: - ako su Vam vrijednosti triglicerida (masnoća u krvi) veće od 3,4 mmol/l
English: Cholestagel decreased the Cmax and AUC of sustained-release verapamil by approximately 31% and 11%, respectively.
Croatian: Cholestagel je za približno 31% smanjio Cmax i za približno 11% AUC verapamila u formulaciji s produljenim oslobađanjem.
English: In an interaction study in healthy volunteers, Cholestagel reduced the Cmax of norethindrone as well as the AUC and Cmax of ethinylestradiol when administered simultaneously with the oral contraceptive pill.
Croatian: U ispitivanju interakcija u zdravih dobrovoljaca, Cholestagel primijenjen istodobno s oralnom kontracepcijskom tabletom smanjio je Cmax noretindrona, kao i AUC i Cmax etinilestradiola.
English: As noted in general, when a drug interaction cannot be excluded with a concomitant medicinal product, Cholestagel should be administered at least four hours before or at least four hours after the concomitant medication to minimise the risk of reduced absorption of the concomitant medication.
Croatian: Općenito, ako nije moguće isključiti interakciju s istodobno primijenjenim lijekom, Cholestagel se mora uzimati najmanje 4 sata prije ili najmanje 4 sata nakon popratnog lijeka kako bi se što više umanjio rizik od smanjene apsorpcije popratnog lijeka.
English: You should take your Cholestagel tablets with food and liquid.
Croatian: Cholestagel tablete morate uzimati uz obrok, s tekućinom.
English: 180 tablets with carton
Croatian: 180 tableta s kutijom
English: Pharmacotherapeutic group: Lipid modifying agent, bile acid sequestrants, ATC code: C10A C 04
Croatian: ATK oznaka: C10A C 04
English: Cholestagel resulted in a statistically significant LDL-C reduction of 11% and 11% at 6 and 12 weeks vs an increase of 7% and 1% in the placebo group; mean baseline levels were 3.75 mmol/L and 3.86 mmol/L, respectively.
Croatian: 12. tjednu, u usporedbi s povišenjem od 7% odnosno 1% u skupini koja je dobivala placebo; prosječna početna vrijednost u skupini koja je dobivala Cholestagel bila je 3,75 mmol/l, a u skupini koja je dobivala placebo 3,86 mmol/l.
English: Common: Serum triglycerides increased Uncommon :Serum transaminases increased
Croatian: Često: povišene vrijednosti triglicerida u serumu Manje često: povišene vrijednosti transaminaza u serumu * više informacija navedeno je u nastavku ** nuspojave iz iskustva nakon stavljanja lijeka u promet
English: The recommended starting dose of Cholestagel is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets once per day with a meal.
Croatian: Preporučena početna doza lijeka Cholestagel je 6 tableta na dan, a mogu se uzeti 3 tablete dvaput na dan uz obroke ili 6 tableta jedanput na dan uz obrok.
English: België/Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: + 32 (0)2 710 54 00
Croatian: Sanofi Belgium Tél/Tel: + 32 (0)2 710 54 00
English: Therefore, patients taking both ciclosporin and Cholestagel should have their blood concentrations monitored prior to and frequently after when Cholestagel therapy is stopped with their ciclosporin dose adjusted accordingly.
Croatian: Iz tog razloga, bolesnicima koji uzimaju i ciklosporin i Cholestagel treba odrediti koncentraciju ciklosporina u krvi prije obustave lijeka Cholestagel i često je kontrolirati nakon obustave te sukladno nalazima prilagoditi doziranje ciklosporina.
English: As described in Section 2, if you will be taking Cholestagel along with another medicine it is possible that your doctor will advise you to take Cholestagel at least 4 hours before or at least 4 hours after taking the other medicine.
Croatian: Kako je opisano u dijelu 2, budete li Cholestagel uzimali s nekim drugim lijekom, liječnik će Vam možda preporučiti da Cholestagel uzimate najmanje
English: Additionally, if you have any condition that could cause you to have a deficiency of vitamins A, D, E or K, your doctor may want to check your vitamin levels periodically while you are taking Cholestagel.
Croatian: Osim toga, ako bolujete od neke bolesti koja bi mogla izazvati nedostatak vitamina A, D, E ili K,
English: If you are prescribed Cholestagel and any other medicine together you must also read the patient information leaflet that comes with that particular medicine before you start to take your medicine.
Croatian: - ako imate začepljenje u crijevima ili žučovodima (kanalićima koji provode žuč) Ako Vam je Cholestagel propisan zajedno s nekim drugim lijekom, prije nego počnete uzimati lijekove, morate pročitati i Uputu o lijeku priloženu u pakiranju tog drugog lijeka.
English: Common (may affect up to 1 in 10 people): vomiting, diarrhoea, indigestion, abdominal pain, abnormal stools, feeling sick, bloating, headache, raised levels of triglycerides (fats) in your blood.
Croatian: poremećaj stolice, mučnina, nadutost, glavobolja, povišene razine triglicerida (masnoća) u krvi.
English: Glipizide should be administered at least 4 hours prior to colesevelam.
Croatian: Glipizid se mora primijeniti najmanje 4 sata prije kolesevelama.
English: The recommended dose for Cholestagel is 3 tablets taken twice a day with meals or 6 tablets a day with a meal.
Croatian: Preporučena doza lijeka Cholestagel je 3 tablete dvaput na dan uz obrok ili 6 tableta jedanput na dan uz obrok.
English: In addition, based on theoretical grounds Cholestagel should be administered at least 4 hours after ciclosporin in order to further minimise the risks related to the concomitant administration of ciclosporin and Cholestagel.
Croatian: Osim toga, teoretski, kako bi se još više umanjio rizik zbog istodobnog uzimanja ciklosporina i lijeka Cholestagel, Cholestagel treba primjenjivati najmanje 4 sata nakon ciklosporina.
English: 180 film-coated tablets
Croatian: 24 filmom obložene tablete 100 filmom obloženih tableta 180 filmom obloženih tableta
English: Therefore glimepiride should be administered at least 4 hours prior to colesevelam.
Croatian: Stoga se glimepirid mora primijeniti najmanje 4 sata prije kolesevelama.
English: In an interaction study in healthy volunteers, Cholestagel reduced the AUC and Cmax of levothyroxine when administered either concomitantly or after 1 hour.
Croatian: U ispitivanju interakcija u zdravih dobrovoljaca Cholestagel primijenjen istodobno ili 1 sat nakon levotiroksina smanjio je AUC i Cmax levotiroksina.
English: The background incidence of flatulence and diarrhoea were higher in patients receiving placebo in the same controlled clinical studies.
Croatian: U istim kontroliranim kliničkim ispitivanjima je incidencija flatulencije i proljeva bila češća u bolesnika koji su dobivali placebo.
English: Driving and using machines Your ability to drive or operate machines is not affected by taking Cholestagel tablets.
Croatian: Cholestagel tablete ne utječu na sposobnost upravljanja vozilima i rada na strojevima.
English: For all patients, Cholestagel resulted in a statistically significant LDL-C reduction of 11% at 3.8 g/day and 4% at 1.9 g/day, versus a 3% increase in the placebo group.
Croatian: U svih je bolesnika Cholestagel doveo do statistički značajnog sniženja LDL kolesterola od 11% uz dozu od 3,8 g na dan, odnosno 4%
English: The safety and efficacy of Cholestagel in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, inflammatory bowel disease, liver failure or major gastrointestinal tract surgery have not been established.
Croatian: poremećajima gutanja, teškim poremećajima gastrointestinalnog motiliteta, upalnom bolešću crijeva,
English: NAME OF THE MEDICINAL PRODUCT Cholestagel 625 mg film-coated tablets
Croatian: Cholestagel 625 mg filmom obložene tablete
English: This causes an increased demand for cholesterol in the liver cells, resulting in the dual effects of increasing transcription and activity of the cholesterol biosynthetic enzyme, hydroxymethyl-glutaryl-coenzyme A (HMG-CoA) reductase, and increasing the number of hepatic low-density lipoprotein receptors.
Croatian: Zbog toga u stanicama jetre raste potreba za kolesterolom, što za posljedicu ima dvojni učinak: povećanu transkripciju i aktivaciju enzima za biosintezu kolesterola,
English: Ursodeoxycholic acid
Croatian: Ursodeoksikolna kiselina
English: NAME OF THE MEDICINAL PRODUCT Cholestagel 625 mg film-coated tablets Colesevelam
Croatian: Uputa o lijeku: Informacija za korisnika Cholestagel 625 mg filmom obložene tablete kolesevelam
English: • Oral contraceptives (medicines to prevent pregnancy) It is important you take Cholestagel at least 4 hours after you take the oral contraceptive to ensure that the effectiveness of the contraceptive is not affected.
Croatian: Važno je da Cholestagel uzmete najmanje 4 sata nakon uzimanja kontracepcijske tablete kako biste bili sigurni da on neće utjecati na djelotvornost kontraceptiva.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 625 mg colesevelam (as hydrochloride).
Croatian: Jedna tableta sadrži 625 mg kolesevelama (u obliku kolesevelamklorida).
English: Olmesartan should be administered at least 4 hours prior to colesevelam.
Croatian: Olmesartan se mora primjenjivati najmanje 4 sata prije kolesevelama.
English: Reductions were also seen for non-HDL-C, Total-C and Apo B. A small 5%, non-significant increase in triglycerides was noted.
Croatian: Zabilježen je i blagi porast vrijednosti triglicerida od 5%, koji nije bio značajan.
English: Cholestagel tablets are off-white, capsule-shaped film-coated tablets and imprinted with ‘C625' on one side.
Croatian: Cholestagel tablete su bjelkaste filmom obložene tablete u obliku kapsule, s utisnutom oznakom
English: The recommended dose of Cholestagel for combination with a statin with or without ezetimibe is 4 to 6 tablets per day.
Croatian: Kombinirana terapija Preporučena doza lijeka Cholestagel u kombinaciji sa statinom, sa ili bez ezetimiba, iznosi 4 do
English: Cholestagel had no effect on the bioavailability of lovastatin in an interaction study.
Croatian: U ispitivanju interakcija Cholestagel nije imao učinka na bioraspoloživost lovastatina.
English: Levothyroxine
Croatian: Levotiroksin
English: Microcrystalline cellulose (E460) Silica colloidal anhydrous Magnesium stearate Purified water
Croatian: bezvodni, koloidni silicijev dioksid magnezijev stearat pročišćena voda Film ovojnica:
English: No interaction was observed when Cholestagel was administered one hour after repaglinide.
Croatian: Kada je Cholestagel primijenjen jedan sat nakon repaglinida, nisu zabilježene interakcije.
English: Cholestagel 625 mg film-coated tablets Colesevelam
Croatian: Cholestagel 625 mg filmom obložene tablete kolesevelam
English: Cellulose (E460), microcrystalline Silica, colloidal anhydrous Magnesium stearate Water, purified
Croatian: Jezgra tablete: celuloza, mikrokristalična (E460)
English: Constipation or bloating could occur.
Croatian: Mogu se pojaviti zatvor ili nadutost.
English: If you take more Cholestagel than you should Please contact your doctor.
Croatian: Ako uzmete više lijeka Cholestagel nego što ste trebali
English: Iron oxide black (E172)
Croatian: željezov oksid, crni (E172) hipromeloza (E464) propilenglikol
English: Caution should be exercised when prescribing to breast-feeding women.
Croatian: Potreban je oprez kada se ovaj lijek propisuje dojiljama.
English: Cholestagel predominantly binds hydrophobic bile acids.
Croatian: Cholestagel pretežno veže hidrofobne žučne kiseline.
English: No interaction was observed when Cholestagel was administered at least four hours after levothyroxine.
Croatian: Kada je Cholestagel primijenjen najmanje 4 sata nakon levotiroksina, nisu zabilježene interakcije.
English: Vistor hf.
Croatian: PRILOG III.
English: Effects on triglyceride levels
Croatian: Cholestagel može povisiti razine triglicerida.
English: What Cholestagel contains
Croatian: Sadržaj pakiranja i druge informacije Što Cholestagel sadrži
English: No interaction was observed when Cholestagel was administered four hours after glyburide.
Croatian: Kada je Cholestagel primijenjen najmanje 4 sata nakon gliburida, nisu zabilježene interakcije.
English: This percentage may vary according to ethnic background.
Croatian: Ovaj postotak može varirati ovisno o etničkom podrijetlu.
English: It helps control your allergic reaction and its symptoms.
Croatian: Pomaže u kontroli alergijske reakcije i njezinih simptoma.
English: Symptomatic and supportive treatment is recommended.
Croatian: Preporučuje se simptomatsko i suportivno liječenje.
English: ● yellowing of the skin and/or eyes
Croatian: ● žutilo kože i/ili očiju
English: Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
Croatian: Desloratadin se umjereno veže (83% - 87%) na proteine plazme.
English: Children 1 through 5 years of age:
Croatian: Djeca u dobi od 1 do 5 godina:
English: Patients should be informed that most people do not experience drowsiness.
Croatian: Bolesnike treba obavijestiti da većina ljudi neće osjetiti omamljenost.
English: Swallow the dose of oral solution and then drink some water.
Croatian: Progutajte dozu oralne otopine, a zatim popijte malo vode.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 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).
Croatian: Učestalost pojavljivanja 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Date of first authorisation: 15 January 2001 Date of latest renewal: 15 January 2006
Croatian: Datum posljednje obnove odobrenja: 15. siječnja 2006.
English: If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.
Croatian: Ako primjetite bilo koju od ovih ozbiljnih nuspojava, prestanite uzimati lijek i odmah potražite hitni medicinski savjet.
English: Desloratadine is the primary active metabolite of loratadine.
Croatian: Desloratadin je primarni aktivni metabolit loratadina.
English: Other medicines and Aerius
Croatian: Drugi lijekovi i Aerius
English: The clinical relevance of these observations remains to be confirmed.
Croatian: Klinički značaj tih pojava tek se treba utvrditi.
English: The dose must be taken as soon as the blister has been opened.
Croatian: Doza se mora uzeti čim se otvori blister.
English: The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products cannot be fully excluded.
Croatian: Enzim odgovoran za metabolizam desloratadina još nije utvrđen stoga se neke interakcije s drugim lijekovima ne mogu potpuno isključiti.
English: Therefore, caution is recommended if alcohol is taken concomitantly.
Croatian: Stoga se preporučuje oprez ako se alkohol uzima istodobno s lijekom.
English: In each trial, the effects were sustained over the 24 hour dosing interval.
Croatian: U svakom ispitivanju učinci su održani tijekom intervala doziranja od 24 sata.
English: ● increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium
Croatian: ● povećana osjetljivost kože na sunčevu svjetlost, čak i u slučaju slabog sunca, i na UV (ultraljubičastu) svjetlost, na primjer UV svjetlost solarija
English: Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
Croatian: Simptomi su ublaženi tijekom čitavog dana, što Vam pomaže da nastavite s uobičajenim dnevnim aktivnostima i da normalno spavate.
English: ● weight increased, increased appetite
Croatian: ● povećana tjelesna težina, povećan apetit
English: In the event of overdose, consider standard measures to remove unabsorbed active substance.
Croatian: U slučaju predoziranja, primijenite standardne mjere za uklanjanje neapsorbirane djelatne tvari.