FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: glavobol, omotica, tresenje, suha usta, težave s požiranjem, sprememba okusa, razbijanje srca, trda stolica, vnetje ali bolečina trebuha ali črevesja, spremenjeno odvajanje blata, nespečnost, srbenje, suha koža, izpuščaj, koprivnica, srbeče rdeče lise, nabiranje krvi npr. pod kožo (hematom), bolečine v sklepih, bolečine v hrbtu, bolečine v okončinah, mišične bolečine ali spazmi, zvišane ravni paratiroidnega hormona (beljakovine), nekaterih lipidov v krvi in jetrnih encimov, nizka raven folatov (vitamina).
English: 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.
Slovenian: Kolestilan je znatno znižal LDL-holesterol v serumu za 17,8; 25,6; 29,4; 34,8 oz. 33,4 % pri 3, 6, 9, 12 oz. 15 g/dan v 12. tednu v primerjavi s placebom v študiji s fiksnim odmerkom.
English: 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.
Slovenian: Bolnice, ki zanosijo, in pri katerih ocena razmerja med koristmi in tveganji potrdi nadaljevanje zdravljenja z zdravilom BindRen, bo morda treba dodajati vitamine, glejte poglavje 4.4.
English: Serum parathyroid hormone (PTH)
Slovenian: Paratiroidni hormon (PTH) v serumu
English: About high blood phosphorus levels (hyperphosphataemia) If your kidneys no longer function properly you may undergo dialysis, which replaces many of the functions of your kidneys.
Slovenian: Če vaše ledvice ne delujejo več pravilno, se morda zdravite z dializo, ki nadomesti številne funkcije vaših ledvic.
English: 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.
Slovenian: Bolnice, ki dojijo, in pri katerih ocena razmerja med koristmi in tveganji potrdi nadaljevanje zdravljenja z zdravilom BindRen, bo morda treba dodajati vitamine, glejte poglavje 4.4.
English: However, intestinal folate absorption may be impaired during long-term treatment of BindRen.
Slovenian: Vendar pa lahko dolgotrajno zdravljenje z zdravilom BindRen vpliva na absorpcijo folata v črevesju.
English: The active substance is colestilan.
Slovenian: Zdravilna učinkovina je kolestilan.
English: • Severe gastrointestinal disorders such as chronic or severe constipation, intestinal stenosis, intestinal diverticulum, sigmoid colitis, gastrointestinal ulcers, or recent major gastrointestinal surgery
Slovenian: • hudimi gastrointestinalnimi motnjami, kot so kronično ali hudo zaprtje, stenoza črevesja, divertikel črevesja, sigmoidni kolitis, gastrointestinalne razjede ali nedavna velika
English: Hepatic enzymes increased
Slovenian: zvišanje jetrnih encimov
English: BindRen is not absorbed from the gastrointestinal tract but may affect the bioavailability or absorption rate of other medicinal products.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravilo BindRen se iz prebavil ne absorbira, vendar lahko vpliva na biološko razpoložljivost ali hitrost absorpcije drugih zdravil.
English: Acetic acid esters of mono- and diglycerides of fatty acids Polysorbate 80
Slovenian: Filmska obloga hipromeloza acetatni estri mono-in digliceridov maščobnih kislin polisorbat 80
English: Elderly population
Slovenian: Posebne populacije Starejši bolniki
English: BindRen is indicated for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
Slovenian: Zdravilo BindRen je indicirano za zdravljenje hiperfosfatatemije pri odraslih bolnikih s kronično boleznijo ledvic (KBL) 5. stopnje, ki so na hemodializi ali peritonealni dializi.
English: BindRen did not induce a clinically relevant reduction in folate absorption during clinical studies of up to one year.
Slovenian: Zdravilo BindRen ni v kliničnih študijah do eno leto induciralo nobenega klinično pomembnega zmanjšanja absorpcije folata.
English: Common (may affect up to 1 in 10 people) side effects: feeling sick (nausea), vomiting, a burning sensation in your stomach, diarrhoea, bloating, stomach ache and bowel pain, gas, a decreased appetite and low blood calcium.
Slovenian: Pogosti (pojavijo se lahko pri 1 od 10 bolnikov) neželeni učinki: občutek slabosti (navzea), bruhanje, pekoč občutek v trebuhu, driska, napenjanje, bolečine v trebuhu in črevesju, plini, zmanjšanje apetita in nizka raven kalcija v krvi.
English: The colestilan-bound phosphorus is then excreted from your body in faeces.
Slovenian: Fosfor, vezan na kolestilan, se nato izloči iz telesa v blatu.
English: • Dysphagia or swallowing disorders
Slovenian: • disfagijo ali motnjami v požiranju,
English: BindRen 1 g film-coated tablets colestilan
Slovenian: BindRen 1 g filmsko obložene tablete kolestilan
English: BindRen contains colestilan.
Slovenian: BindRen in levotiroksin.
English: BindRen contains the active substance colestilan.
Slovenian: Zdravilo BindRen vsebuje zdravilno učinkovino kolestilan.
English: Fax: +44 (0)207 065 5050
Slovenian: Velika Britanija tel.: +44 (0)207 065 5000 faks: +44 (0)207 065 5050 e-pošta: info@mt-pharma-eu.com
English: BindRen is indicated for use in patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
Slovenian: Zdravilo BindRen je indicirano za uporabo pri bolnikih s kronično boleznijo ledvic (KBL) 5. stopnje, ki so na hemodializi ali peritonealni dializi.
English: The recommended starting dose is 6-9 g per day taken as 2 g or 3 g three times per day with meals.
Slovenian: Priporočeni začetni odmerek je 6-9 g, ki ga vzamete 2-3 g trikrat na dan s hrano.
English: (≥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).
Slovenian: (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: However, decreased blood concentrations have been reported for medicinal products with a similar mechanism of action to BindRen.
Slovenian: Vendar pa so za zdravila s podobnim mehanizmom delovanja kot zdravilo BindRen poročali o znižanju koncentracij v krvi.
English: What BindRen contains
Slovenian: Kaj vsebuje navodilo
English: Serum phosphorus
Slovenian: Fosfor v serumu
English: Colestilan may also bind uric acid in the gastrointestinal tract.
Slovenian: Kolestilan lahko veže tudi sečno kislino v prebavilih.
English: - If you get any side effects, talk to your doctor or pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
English: (peritonitis) - low levels of albumin (a protein) in your blood
Slovenian: - nedavno vnetje membrane, ki oblikuje oblogo abdominalne (trebušne) votline (peritonitis), - nizke ravni albumina (beljakovine) v krvi.
English: Haemorrhage and increased clotting parameters (PT and aPTT) were evident in rats following repeat administration.
Slovenian: Pri podganah so se po ponavljajočih odmerkih pokazale krvavitve in višji parametri strjevanja (PT in aPTT).
English: Gastrointestinal haemorrhage, oesophagitis, faecaloma, dysphagia, change in bowel habit, dry mouth
Slovenian: gastrointestinalna krvavitev, ezofagitis, fekalom, disfagija, spremenjeno odvajanje blata, suha usta
English: See section 4.
Slovenian: (glejte poglavje 4).
English: In the first study, the mean serum phosphorus level was 2.33 mmol/L at baseline and 1.96 mmol/L (mean reduction by 0.36 mmol/L) at week 12 on a colestilan mean daily dose of 11.5 g. Similarly in the second study, the mean serum phosphorus level was 2.44 mmol/L at baseline and 1.94 mmol/L at week 12 (mean reduction by 0.50 mmol/L) on a colestilan mean daily dose of
Slovenian: V prvi študiji je bila povprečna raven fosforja v serumu 2,33 mmol/l ob izhodišču in 1,96 mmol/l (povprečno znižanje za 0,36 mmol/l) v 12. tednu pri povprečnem dnevnem odmerku kolestilana 11,5 g. V prvi študiji je bila povprečna raven fosforja v serumu 2,44 mmol/l ob izhodišču in 1,94 mmol/l v 12. tednu (povprečno znižanje za 0,50 mmol/l) pri povprečnem dnevnem odmerku kolestilana 13,1 g. Primerjava deležev bolnikov, ki so se odzvali na zdravljenje (z znižanjem plazemskega fosforja ≤ 1,78 mmol/l in/ali z znižanjem od izhodiščne vrednosti ≥ 0,3 mmol/l) je bila v dveh študijah 50,4 % in 43,8 % (v primerjavi s placebom 30,8 % in 26,3 %).
English: The following side effects have also been seen in patients taking BindRen:
Slovenian: Pri bolnikih, ki so uporabljali zdravilo BindRen, so opazili še naslednje neželene učinke:
English: 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.
Slovenian: in III. faze, v katerih je sodelovalo 1.410 bolnikov s KBL 5. faze na dializi,
English: No data are available on the safety and effectiveness of BindRen in children and adolescents (below the age of 18 years).
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila BindRen pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
English: How BindRen works
Slovenian: Kako deluje zdravilo BindRen
English: Posology The recommended starting dose is 6-9 g per day (2-3 g three times daily).
Slovenian: Odmerjanje Priporočeni začetni odmerek je 6-9 g na dan (2-3 g trikrat na dan).
English: Serum calcium-phosphorus ion product
Slovenian: Produkt ionov kalcija in fosforja v serumu
English: 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.
Slovenian: ricinusovo olje, hidrogenirano, etilceluloza, hipromeloza, makrogol 8000, trietil citrat, titanov dioksid, smukec, cetanol and natrijev lavrilsulfat.
English: Talk to your doctor or pharmacist before taking BindRen if you are suffering from any of the following problems, since this medicine may not be right for you: - swallowing problems - severe problems with stomach or bowel movement, such as constipation, ulcers in the stomach or the gut or haemorrhoids, since these problems may lead to increased risk of e.g. bleeding from the intestines - recent major stomach or bowel surgery - gall bladder obstruction - severe liver problems - seizures - recent history of inflammation of the membrane that forms the lining of the abdominal (tummy) cavity
Slovenian: Pred začetkom jemanja zdravila BindRen se posvetujte s svojim zdravnikom ali farmacevtom, če imate katero od naslednjih težav, saj morda to zdravilo ni primerno za vas: - težave s požiranjem, - hude težave z želodcem ali odvajanjem blata, kot sta zaprtost, razjeda v želodcu ali črevesju;
English: Flexible-dose studies:
Slovenian: Študije s fiksnimi odmerki:
English: Close monitoring of patients with hypothyroidism is recommended when levothyroxine is co-administered with BindRen (see section 4.5).
Slovenian: Pri sočasnem dajanju levotiroksina skupaj z zdravilom BindRen bolnikom s hipotiroidizmom se priporoča skrbno nadziranje (glejte poglavje 4.5).
English: 4.4 Special warnings and precautions for use
Slovenian: • Zapora želodca 4.4 Posebna opozorila in previdnostni ukrepi
English: It is recommended that you take BindRen granules as one dose from the sachet with a small amount of water, at the time of a meal or directly after.
Slovenian: Priporočeno je, da jemljete zdravilo BindRen zrnca kot en odmerek iz vrečice z majhno količino vode.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Mitsubishi Tanabe Pharma Europe Ltd.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Mitsubishi Tanabe Pharma Europe Ltd.
English: Intestinal obstruction*
Slovenian: zapora črevesja*
English: Asthenia
Slovenian: nespečnost
English: Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence, abdominal discomfort
Slovenian: trebušna distenzija, navzea, gastritis, dispepsija, driska, flatulenca, nelagodje v trebuhu
English: - BindRen 2 g granules: each sachet contains 2 g of colestilan.
Slovenian: - Zdravilo BindRen 2 g zrnca: ena vrečica vsebuje 2 g kolestilana.
English: - BindRen 3 g granules: each sachet contains 3 g of colestilan.
Slovenian: - Zdravilo BindRen 3 g zrnca: ena vrečica vsebuje 3 g kolestilana.
English: NAME OF THE MEDICINAL PRODUCT BindRen 2 g granules colestilan
Slovenian: IME ZDRAVILA BindRen 2 g zrnca kolestilan
English: NAME OF THE MEDICINAL PRODUCT BindRen 1 g film-coated tablets
Slovenian: IME ZDRAVILA BindRen 1 g filmsko obložene tablete
English: Marketing Authorisation Holder Mitsubishi Tanabe Pharma Europe Ltd. Dashwood House
Slovenian: Imetnik dovoljenja za promet z zdravilom Mitsubishi Tanabe Pharma Europe Ltd. Dashwood House
English: Each sachet contains 2 g of granules.
Slovenian: Ena vrečica vsebuje 2 g zrnc.
English: Changes in the bile acid pool in the gastrointestinal tract have also been observed to lower serum glucose.
Slovenian: Opazili so, da glukozo v serumu znižujejo tudi spremembe v količini želodčne kisline v prebavilih.
English: This medicine does not require any special temperature storage conditions.
Slovenian: Za shranjevanje zdravila ni posebnih temperaturnih pogojev.
English: 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).
Slovenian: levotiroksin (ki se uporablja za zdravljenje pomanjkanja ščitničnega hormona) in peroralna kontracepcijska zdravila (estrogen, progestogen ali kombinirane tabletke), zdravila za zaviranje imunskega sistema (kot je ciklosporin, mikofenolat mofetil, takrolimus).
English: NAME OF THE MEDICINAL PRODUCT BindRen 3 g granules colestilan
Slovenian: IME ZDRAVILA BindRen 3 g zrnca kolestilan
English: 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).
Slovenian: Zdravilo BindRen ni v kliničnih študijah do eno leto induciralo nobenega klinično pomembnega zmanjšanja absorpcije vitaminov A, D, E ali K. Vendar pa je potrebna previdnost pri zdravljenju bolnikov z dovzetnostjo za pomanjkanje vitamina K ali vitaminov, topnih v maščobi, kot so bolniki s sindromi malabsorpcije in bolniki, zdravljeni s kumarinskimi antikoagulanti (npr. varfarin).
English: Severe hepatic impairment
Slovenian: - hude težave z jetri,
English: If you get any side effects, talk to you doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
English: INFORMATION IN BRAILLE BindRen 3 g granules
Slovenian: PODATKI V BRAILLOVI PISAVI BindRen 3 g zrnca
English: INFORMATION IN BRAILLE BindRen 2 g granules
Slovenian: PODATKI V BRAILLOVI PISAVI BindRen 2 g zrnca
English: Each sachet contains 3 g of granules.
Slovenian: Ena vrečica vsebuje 3 g zrnc.
English: Serum cholesterol
Slovenian: Holesterol v serumu
English: Granules.
Slovenian: BindRen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BOTTLES - FILM-COATED TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA ZA PRETISNE OMOTE - FILMSKO OBLOŽENE TABLETE
English: NAME OF THE MEDICINAL PRODUCT BindRen 2 g granules
Slovenian: IME ZDRAVILA BindRen 2 g zrnca
English: Fixed-dose study:
Slovenian: Študija s fiksnim odmerkom:
English: They are supplied in 2 g or 3 g sachets in cartons of 30, 60 or 90 sachets.
Slovenian: Na voljo so v vrečicah po 2 g ali 3 g v škatlah s po
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/001-005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/804/001-005
English: Hyperparathyroidism
Slovenian: hiperparatiroidizem
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/014-016
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/804/014-016
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - FILM-COATED TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA ZA PLASTENKE - FILMSKO OBLOŽENE TABLETE
English: CLINICAL PARTICULARS
Slovenian: Klinične študije II.
English: Film-coated tablet.
Slovenian: PRETISNI OMOTI - FILMSKO OBLOŽENE TABLETE
English: Purified water Hydroxypropylcellulose Silica, colloidal anhydrous Castor oil, hydrogenated
Slovenian: 6.1 Seznam pomožnih snovi Jedro tablete prečiščena voda hidroksipropilceluloza silicijev dioksid, koloidni brezvodni ricinusovo olje, hidrogenirano
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/011-013
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/804/011-013
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: NAME OF THE MEDICINAL PRODUCT BindRen 3 g granules
Slovenian: IME ZDRAVILA BindRen 3 g zrnca
English: Musculoskeletal and connective tissue disorders Uncommon:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/006-010
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/804/006-010
English: Blisters This medicine does not require any special storage conditions.
Slovenian: Pretisni omoti Za shranjevanje zdravila niso potrebna posebna navodila.
English: Bottles
Slovenian: Plastenke
English: Infections and infestations Uncommon:
Slovenian: Bolezni prebavil Pogosti:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION BindRen 2 g granules colestilan
Slovenian: IME ZDRAVILA IN POT(I) UPORABE BindRen 2 g zrnca kolestilan peroralna uporaba
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION BindRen 3 g granules colestilan
Slovenian: IME ZDRAVILA IN POT(I) UPORABE BindRen 3 g zrnca kolestilan peroralna uporaba
English: How to store BindRen
Slovenian: Shranjevanje zdravila BindRen
English: NAME OF THE MEDICINAL PRODUCT BindRen 1 g film-coated tablets colestilan
Slovenian: Navodilo za uporabo BindRen 1 g filmsko obložene tablete kolestilan
English: Serum uric acid
Slovenian: Kalcij v serumu
English: Cetyl alcohol Sodium laurilsulfate Castor oil, hydrogenated
Slovenian: Filmska obloga etilceluloza hipromeloza makrogol 8000 trietil citrat titanov dioksid smukec cetil alkohol natrijev lavrilsulfat ricinusovo olje, hidrogenirano
English: BindRen 2 g granules BindRen 3 g granules colestilan
Slovenian: VREČICE ZA 2 G ZRNC
English: Nervous system disorders Uncommon:
Slovenian: Bolezni živčevja Občasni:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 2 G GRANULES IN SACHETS
Slovenian: ZUNANJA ŠKATLA 2 G ZRNCA V VREČICAH
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 3 G GRANULES IN SACHETS
Slovenian: ZUNANJA ŠKATLA 3 G ZRNCA V VREČICAH
English: • Seizure disorders
Slovenian: • epileptičnimi napadi,
English: - swallowing problems - severe problems with stomach or bowel movement, such as constipation, ulcers in the stomach or the gut or haemorrhoids, since these problems may lead to increased risk of e.g. bleeding from the intestines - recent major stomach or bowel surgery - gall bladder obstruction - severe liver problems - seizures - recent history of inflammation of the membrane that forms the lining of the abdominal (tummy) cavity
Slovenian: hemeroide, saj lahko te težave pomenijo tveganje za pojav npr. krvavitev iz črevesja, - nedavno veliko operacijo želodca ali črevesja, - zaporo žolčnika,
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: Bolezni kože in podkožja
English: Skin and subcutaneous tissue disorders Uncommon:
Slovenian: Bolezni jeter, žolčnika in žolčevodov Občasni:
English: Shellac
Slovenian: astenija
English: Tabulated list of adverse reactions A tabulated list of frequencies was defined using the following convention: very common (≥1/10); common
Slovenian: Neželeni učinki v obliki preglednice so bili razvrščeni po naslednjem pogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki
English: This summary was last updated in 06-2008.
Slovenian: Povzetek je bil nazadnje posodobljen 07-2008.
English: The marketing authorisation was renewed on 29 July 2003 and on 29 July 2008.
Slovenian: Dovoljenje za promet z zdravilom je bilo obnovljeno dne 29. julija 2003 in 29. julija 2008.
English: Neither the patients nor the doctors knew which treatment each patient was taking until the end of the study.
Slovenian: Niti zdravniki niti bolniki do konca študije niso vedeli, katero zdravljenje bolniki prejemajo.
English: This helps weight reduction.
Slovenian: To pomaga pri zmanjševanju telesne mase.
English: It is available as turquoise capsules (120 mg).
Slovenian: Na voljo je v kapsulah turkizne barve (120 mg).
English: The food in the diet should be spread over three main meals.
Slovenian: Dietna prehrana mora biti porazdeljena med tri glavne obroke.
English: These symptoms generally occur at the beginning of treatment, and go away after some time.
Slovenian: Našteti simptomi se večinoma pojavijo na začetku zdravljenja in sčasoma izginejo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xenical to Roche Registration Limited on 29 July 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Xenical, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 29. julija 1998.
English: In all studies, the main measure of effectiveness was the change in weight.
Slovenian: V vseh študijah je bilo glavno merilo učinkovitosti sprememba telesne mase.
English: The patient should be on a diet in which about 30% of the calories come from fat, and which is rich in fruit and vegetables.
Slovenian: Bolnik mora biti na dieti, v kateri okoli 30 % kalorij izvira iz maščob in ki je bogata s sadjem in zelenjavo.
English: The effects of Xenical were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Xenical so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The body cannot use this dietary fat for energy or convert it into fat tissue.
Slovenian: Tega deleža maščob telo ne more uporabiti kot vira energije ali ga pretvoriti v maščobno tkivo.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) XENICAL EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) XENICAL Povzetek EPAR za javnost
English: When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about 30% of the fat eaten in the meal to pass through the gut undigested.
Slovenian: Če so ti encimi blokirani, potem ne morejo razkrojiti nekaterih maščob, zaradi česar se približno 30 % maščob, zaužitih z hrano, izloči skozi črevo neprebavljenih.