natgillin/translations-raw huggingface dataset:
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.
Pri osebah z ≥7,0 % HbA1c ob izhodišču je kolestilan pokazal znižanje med 0,36 do 1,38 % v 12. tednu v študiji s fiksnim odmerkom in za 0,94 in 0,91 % v 12. tednu v dveh študijah s prilagodljivim odmerkom.
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)
Kaj morate vedeti, preden boste vzeli zdravilo BindRen Ne jemljite zdravila BindRen če ste alergični na kolestilan ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
Tremor, dizziness, headache, dysgeusia
tremor, omotica, glavobol, disgevzija
Rare (may affect up to 1 in 1000 people) side effects: blockage of intestines, a low level of vitamin K, obstruction of the blood vessels that supply the heart muscle and swelling of the ankles or extremities.
Redki (pojavijo se lahko pri do 1 od 1.000 bolnikih) neželeni učinki: zapora črevesja, nizke vrednosti vitamina K, zapora žil, ki oskrbujejo srčno mišico s krvjo, otekli gležnji ali okončine.
Folate deficiency
Pomanjkanje folata
BindRen is not absorbed from the gastrointestinal tract of healthy volunteers following oral administration of 14C-radiolabelled colestilan.
Zdravilo BindRen se ni absorbiralo iz prebavil zdravih prostovoljcev po peroralnem dajanju s 14C
However, BindRen did not induce any clinically relevant change in chloride and bicarbonate on treatment for up to one year.
Vendar pa zdravilo BindRen pri zdravljenju do enega leta ni induciral nobenih klinično pomembnih sprememb klorida in bikarbonata.
Caution should be exercised when prescribing BindRen to patients receiving immunosuppressants.
Pri predpisovanju zdravila BindRen bolnikom, ki prejemajo imunosupresive, je potrebna previdnost.
INFORMATION IN BRAILLE BindRen 1 g tablets
PODATKI V BRAILLOVI PISAVI BindRen 1 g tablete
Serum phosphorus Fixed-dose study:
Fosfor v serumu Študija s fiksnim odmerkom:
Single dose interaction studies demonstrated that the bioavailability of ciprofloxacin, warfarin and enalapril were not affected when co-administered with BindRen (6-9 g/day).
Študije interakcije pri enem odmerku so pokazale, da sočasno dajanje zdravila BindRen (6-9 g/dan) ni vplivalo na biološko razpoložljivost ciprofloksacina, varfarina in enalaprila.
In addition, reduced bioavailability of other medicinal products by changes in enterohepatic circulation, for example, steroid hormones with potential impairment of the effectiveness of oral contraceptives, have been reported for medicinal products with a similar mechanism of action to BindRen.
Poleg tega so pri zdravilih s podobnim mehanizmom delovanja kot zdravilo BindRen poročali o zmanjšani biološki razpoložljivosti drugih zdravil zaradi sprememb v enterohepatični cirkulaciji, na primer steroidnih hormonov z možnim vplivom na učinkovitost peroralnih kontraceptivov.
Serum calcium In clinical studies, colestilan had no effect on serum calcium levels over a period of up to one year.
Kalcij v serumu V kliničnih študijah kolestilan ni vplival na ravni kalcija v serumu v obdobju do enega leta.
Caution should be exercised when prescribing BindRen to patients also taking anti-seizure medicinal products.
Pri predpisovanju zdravila BindRen bolnikom, ki jemljejo tudi zdravila proti epilepsiji, je potrebna previdnost.
Elemental calcium should be given as a supplement in case of hypocalcaemia.
V primeru hipokalciemije je treba bolniku dajati dodatek elementarnega kalcija.
Hyperparathyroidism BindRen alone is not indicated for the control of hyperparathyroidism.
Zdravilo BindRen ni indicirano za obvladovanje hiperparatiroidizma, če se uporablja samo.
Muscle spasm, musculoskeletal pain, arthralgia, back pain, pain in extremities
mišični spazem, mišično-skeletne bolečine, artralgija, bolečine v hrbtu, bolečine v okončinah
Non-clinical data reveal no direct special hazard for humans based on conventional studies of safety pharmacology, single- and repeated-dose toxicity, genotoxicity, carcinogenic potential or toxicity to reproduction and development.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnem in ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega neposrednega tveganja za človeka.
Pack sizes: 30, 60 or 90 sachets per carton.
30, 60 ali 90 vrečic na škatlo.
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.
Druge sestavine zdravila so prečiščena voda, hidroksipropilceluloza, silicijev dioksid, koloidni brezvodni, ricinusovo olje, hidrogenirano, hipromeloza, acetatni estri mono-in digliceridov maščobnih kislin, polisorbat 80, šelak, indigo karmin aluminijev lak (E132) in karnauba vosek.
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).
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).
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 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.
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.
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.
Serum parathyroid hormone (PTH)
Paratiroidni hormon (PTH) v serumu
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.
Če vaše ledvice ne delujejo več pravilno, se morda zdravite z dializo, ki nadomesti številne funkcije vaših ledvic.
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.
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.
However, intestinal folate absorption may be impaired during long-term treatment of BindRen.
Vendar pa lahko dolgotrajno zdravljenje z zdravilom BindRen vpliva na absorpcijo folata v črevesju.
The active substance is colestilan.
Zdravilna učinkovina je kolestilan.
• Severe gastrointestinal disorders such as chronic or severe constipation, intestinal stenosis, intestinal diverticulum, sigmoid colitis, gastrointestinal ulcers, or recent major gastrointestinal surgery
• hudimi gastrointestinalnimi motnjami, kot so kronično ali hudo zaprtje, stenoza črevesja, divertikel črevesja, sigmoidni kolitis, gastrointestinalne razjede ali nedavna velika
Hepatic enzymes increased
zvišanje jetrnih encimov
BindRen is not absorbed from the gastrointestinal tract but may affect the bioavailability or absorption rate of other medicinal products.
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.
Acetic acid esters of mono- and diglycerides of fatty acids Polysorbate 80
Filmska obloga hipromeloza acetatni estri mono-in digliceridov maščobnih kislin polisorbat 80
Elderly population
Posebne populacije Starejši bolniki
BindRen is indicated for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
Zdravilo BindRen je indicirano za zdravljenje hiperfosfatatemije pri odraslih bolnikih s kronično boleznijo ledvic (KBL) 5. stopnje, ki so na hemodializi ali peritonealni dializi.
BindRen did not induce a clinically relevant reduction in folate absorption during clinical studies of up to one year.
Zdravilo BindRen ni v kliničnih študijah do eno leto induciralo nobenega klinično pomembnega zmanjšanja absorpcije folata.
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.
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.
The colestilan-bound phosphorus is then excreted from your body in faeces.
Fosfor, vezan na kolestilan, se nato izloči iz telesa v blatu.
• Dysphagia or swallowing disorders
• disfagijo ali motnjami v požiranju,
BindRen 1 g film-coated tablets colestilan
BindRen 1 g filmsko obložene tablete kolestilan
BindRen contains colestilan.
BindRen in levotiroksin.
BindRen contains the active substance colestilan.
Zdravilo BindRen vsebuje zdravilno učinkovino kolestilan.
Fax: +44 (0)207 065 5050
Velika Britanija tel.: +44 (0)207 065 5000 faks: +44 (0)207 065 5050 e-pošta: info@mt-pharma-eu.com
BindRen is indicated for use in patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
Zdravilo BindRen je indicirano za uporabo pri bolnikih s kronično boleznijo ledvic (KBL) 5. stopnje, ki so na hemodializi ali peritonealni dializi.
The recommended starting dose is 6-9 g per day taken as 2 g or 3 g three times per day with meals.
Priporočeni začetni odmerek je 6-9 g, ki ga vzamete 2-3 g trikrat na dan s hrano.
(≥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).
(<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
However, decreased blood concentrations have been reported for medicinal products with a similar mechanism of action to BindRen.
Vendar pa so za zdravila s podobnim mehanizmom delovanja kot zdravilo BindRen poročali o znižanju koncentracij v krvi.
What BindRen contains
Kaj vsebuje navodilo
Serum phosphorus
Fosfor v serumu
Colestilan may also bind uric acid in the gastrointestinal tract.
Kolestilan lahko veže tudi sečno kislino v prebavilih.
- If you get any side effects, talk to your doctor or pharmacist or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
(peritonitis) - low levels of albumin (a protein) in your blood
- nedavno vnetje membrane, ki oblikuje oblogo abdominalne (trebušne) votline (peritonitis), - nizke ravni albumina (beljakovine) v krvi.
Haemorrhage and increased clotting parameters (PT and aPTT) were evident in rats following repeat administration.
Pri podganah so se po ponavljajočih odmerkih pokazale krvavitve in višji parametri strjevanja (PT in aPTT).
Gastrointestinal haemorrhage, oesophagitis, faecaloma, dysphagia, change in bowel habit, dry mouth
gastrointestinalna krvavitev, ezofagitis, fekalom, disfagija, spremenjeno odvajanje blata, suha usta
See section 4.
(glejte poglavje 4).
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
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 %).
The following side effects have also been seen in patients taking BindRen:
Pri bolnikih, ki so uporabljali zdravilo BindRen, so opazili še naslednje neželene učinke:
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.
in III. faze, v katerih je sodelovalo 1.410 bolnikov s KBL 5. faze na dializi,
No data are available on the safety and effectiveness of BindRen in children and adolescents (below the age of 18 years).
Pediatrična populacija Varnost in učinkovitost zdravila BindRen pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
How BindRen works
Kako deluje zdravilo BindRen
Posology The recommended starting dose is 6-9 g per day (2-3 g three times daily).
Odmerjanje Priporočeni začetni odmerek je 6-9 g na dan (2-3 g trikrat na dan).
Serum calcium-phosphorus ion product
Produkt ionov kalcija in fosforja v serumu
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.
ricinusovo olje, hidrogenirano, etilceluloza, hipromeloza, makrogol 8000, trietil citrat, titanov dioksid, smukec, cetanol and natrijev lavrilsulfat.
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
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;
Flexible-dose studies:
Študije s fiksnimi odmerki:
Close monitoring of patients with hypothyroidism is recommended when levothyroxine is co-administered with BindRen (see section 4.5).
Pri sočasnem dajanju levotiroksina skupaj z zdravilom BindRen bolnikom s hipotiroidizmom se priporoča skrbno nadziranje (glejte poglavje 4.5).
4.4 Special warnings and precautions for use
• Zapora želodca 4.4 Posebna opozorila in previdnostni ukrepi
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.
Priporočeno je, da jemljete zdravilo BindRen zrnca kot en odmerek iz vrečice z majhno količino vode.
NAME OF THE MARKETING AUTHORISATION HOLDER Mitsubishi Tanabe Pharma Europe Ltd.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Mitsubishi Tanabe Pharma Europe Ltd.
Intestinal obstruction*
zapora črevesja*
Asthenia
nespečnost
Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence, abdominal discomfort
trebušna distenzija, navzea, gastritis, dispepsija, driska, flatulenca, nelagodje v trebuhu
- BindRen 2 g granules: each sachet contains 2 g of colestilan.
- Zdravilo BindRen 2 g zrnca: ena vrečica vsebuje 2 g kolestilana.
- BindRen 3 g granules: each sachet contains 3 g of colestilan.
- Zdravilo BindRen 3 g zrnca: ena vrečica vsebuje 3 g kolestilana.
NAME OF THE MEDICINAL PRODUCT BindRen 2 g granules colestilan
IME ZDRAVILA BindRen 2 g zrnca kolestilan
NAME OF THE MEDICINAL PRODUCT BindRen 1 g film-coated tablets
IME ZDRAVILA BindRen 1 g filmsko obložene tablete
Marketing Authorisation Holder Mitsubishi Tanabe Pharma Europe Ltd. Dashwood House
Imetnik dovoljenja za promet z zdravilom Mitsubishi Tanabe Pharma Europe Ltd. Dashwood House
Each sachet contains 2 g of granules.
Ena vrečica vsebuje 2 g zrnc.
Changes in the bile acid pool in the gastrointestinal tract have also been observed to lower serum glucose.
Opazili so, da glukozo v serumu znižujejo tudi spremembe v količini želodčne kisline v prebavilih.
This medicine does not require any special temperature storage conditions.
Za shranjevanje zdravila ni posebnih temperaturnih pogojev.
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).
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).
NAME OF THE MEDICINAL PRODUCT BindRen 3 g granules colestilan
IME ZDRAVILA BindRen 3 g zrnca kolestilan
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).
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).
Severe hepatic impairment
- hude težave z jetri,
If you get any side effects, talk to you doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
INFORMATION IN BRAILLE BindRen 3 g granules
PODATKI V BRAILLOVI PISAVI BindRen 3 g zrnca
INFORMATION IN BRAILLE BindRen 2 g granules
PODATKI V BRAILLOVI PISAVI BindRen 2 g zrnca
Each sachet contains 3 g of granules.
Ena vrečica vsebuje 3 g zrnc.
Serum cholesterol
Holesterol v serumu
Granules.
BindRen.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BOTTLES - FILM-COATED TABLETS
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA ZA PRETISNE OMOTE - FILMSKO OBLOŽENE TABLETE
NAME OF THE MEDICINAL PRODUCT BindRen 2 g granules
IME ZDRAVILA BindRen 2 g zrnca
Fixed-dose study:
Študija s fiksnim odmerkom:
They are supplied in 2 g or 3 g sachets in cartons of 30, 60 or 90 sachets.
Na voljo so v vrečicah po 2 g ali 3 g v škatlah s po
MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/001-005
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/804/001-005
Hyperparathyroidism
hiperparatiroidizem
MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/014-016
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/804/014-016
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - FILM-COATED TABLETS
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA ZA PLASTENKE - FILMSKO OBLOŽENE TABLETE
CLINICAL PARTICULARS
Klinične študije II.
Film-coated tablet.
PRETISNI OMOTI - FILMSKO OBLOŽENE TABLETE
Purified water Hydroxypropylcellulose Silica, colloidal anhydrous Castor oil, hydrogenated
6.1 Seznam pomožnih snovi Jedro tablete prečiščena voda hidroksipropilceluloza silicijev dioksid, koloidni brezvodni ricinusovo olje, hidrogenirano
MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/011-013
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/804/011-013
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
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
NAME OF THE MEDICINAL PRODUCT BindRen 3 g granules
IME ZDRAVILA BindRen 3 g zrnca
Musculoskeletal and connective tissue disorders Uncommon:
Bolezni mišično-skeletnega sistema in vezivnega tkiva
MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/006-010
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/804/006-010
Blisters This medicine does not require any special storage conditions.
Pretisni omoti Za shranjevanje zdravila niso potrebna posebna navodila.
Bottles
Plastenke
Infections and infestations Uncommon:
Bolezni prebavil Pogosti:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION BindRen 2 g granules colestilan
IME ZDRAVILA IN POT(I) UPORABE BindRen 2 g zrnca kolestilan peroralna uporaba
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION BindRen 3 g granules colestilan
IME ZDRAVILA IN POT(I) UPORABE BindRen 3 g zrnca kolestilan peroralna uporaba
How to store BindRen
Shranjevanje zdravila BindRen
NAME OF THE MEDICINAL PRODUCT BindRen 1 g film-coated tablets colestilan
Navodilo za uporabo BindRen 1 g filmsko obložene tablete kolestilan
Serum uric acid
Kalcij v serumu
Cetyl alcohol Sodium laurilsulfate Castor oil, hydrogenated
Filmska obloga etilceluloza hipromeloza makrogol 8000 trietil citrat titanov dioksid smukec cetil alkohol natrijev lavrilsulfat ricinusovo olje, hidrogenirano
BindRen 2 g granules BindRen 3 g granules colestilan
VREČICE ZA 2 G ZRNC
Nervous system disorders Uncommon:
Bolezni živčevja Občasni:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 2 G GRANULES IN SACHETS
ZUNANJA ŠKATLA 2 G ZRNCA V VREČICAH
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 3 G GRANULES IN SACHETS
ZUNANJA ŠKATLA 3 G ZRNCA V VREČICAH
• Seizure disorders
• epileptičnimi napadi,
- 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
hemeroide, saj lahko te težave pomenijo tveganje za pojav npr. krvavitev iz črevesja, - nedavno veliko operacijo želodca ali črevesja, - zaporo žolčnika,
PHARMACEUTICAL FORM AND CONTENTS
Bolezni kože in podkožja
Skin and subcutaneous tissue disorders Uncommon:
Bolezni jeter, žolčnika in žolčevodov Občasni:
Shellac
astenija