FrancophonIA/ELRC3.0 huggingface dataset:
English: In the two pivotal phase 3 studies in which patients were dosed with 290 micrograms of linaclotide once daily, linaclotide was only detected in 2 out of 162 patients approximately 2 h following the initial linaclotide dose (concentrations were 0.241 ng/ml to 0.239 ng/ml) and in none of the 162 patients after 4 weeks of treatment.
Slovenian: V dveh ključnih študijah 3. faze, pri katerih so bolniki prejemali odmerek 290 mikrogramov linaklotida enkrat na dan, so linaklotid zaznali pri samo 2 od 162 bolnikov približno 2 uri po začetnem odmerku linaklotida (koncentracije so bile v razponu od 0,241 ng/ml do 0,239 ng/ml), in pri nobenem od 162 bolnikov po 4 tednih zdravljenja.
English: During the 2-weeks pre-treatment baseline period, patients had a mean abdominal pain score of 5.6 (0-10 scale) with 2.2% of abdominal pain-free days, a mean bloating score of 6.6 (0-10 scale), and an average of 1.8 spontaneous bowel movements (SBM)/week.
Slovenian: Med 2-tedenskim izhodiščnim obdobjem pred zdravljenjem so imeli bolniki povprečni rezultat bolečine 5,6 (lestvica 0-10) z 2,2 % dneva brez bolečine v abdomnu, povprečnim rezultatom napenjanja 6,6 (lestvica 0-10) in 1,8 spontanimi defekacijami/teden.
English: Constella with food
Slovenian: Zdravilo Constella skupaj s hrano
English: All patients met Rome II criteria for IBS-C and were required to report a mean abdominal pain score of ≥ 3 on a 0-to-10-point numeric rating scale (criteria that correspond to a moderate to severe IBS population), < 3 complete spontaneous bowel movements and ≤ 5 SBMs per week during a 2-week baseline period.
Slovenian: Vsi bolniki so ustrezali merilom Rome II za sindrom razdražljivega črevesja z zaprtostjo in so morali imeti med 2-tedenskim izhodiščnim obdobjem povprečni rezultat abdominalnih bolečin ≥ 3 na numerični lestvici od 0 do 10 točk (kriterij, ki ustreza populaciji z zmernim do hudim simptomom razdražljivega črevesja), rezultat < 3 za popolno spontano defekacijo in ≤ 5 spontanih defekacij na teden.
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA trda kapsula 28 kapsul.
English: Elderly (>65 years), hypertensive and diabetic patients reported diarrhoea more frequently as compared to the overall IBS-C population included in the clinical trials.
Slovenian: Starostniki (> 65 let), bolniki s povišanim krvnim tlakom in bolniki s sladkorno boleznijo, so pogosteje poročali o driski kot splošna populacija bolnikov s sindromom razdražljivega črevesja z zaprtostjo, vključenih v klinična preskušanja.
English: What Constella is and what it is used for
Slovenian: Kaj je zdravilo Constella in za kaj ga uporabljamo
English: INFORMATION IN BRAILLE constella 290 mcg
Slovenian: constella 290 mcg
English: Diarrhoea is the most common adverse reaction and is consistent with the pharmacological action of the active substance.
Slovenian: Driska je najpogostejši neželeni učinek in je v skladu s farmakološkim delovanjem zdravilne učinkovine.
English: Patients should be aware of the possible occurrence of diarrhoea and lower gastrointestinal bleeding during treatment.
Slovenian: Bolniki morajo vedeti, da se lahko med zdravljenjem pojavi driska in krvavenje iz spodnjih prebavil.
English: The co-primary endpoints in both clinical studies were 12-week IBS degree of relief responder rate and 12 week abdominal pain/discomfort responder rate.
Slovenian: Sočasna primarna opazovana dogodka v obeh kliničnih raziskavah sta bili delež odzivnih oseb s stopnjo olajšanja sindroma razdražljivega črevesja (IBS) pri 12 tednih in delež odzivnih oseb z olajšanjem abdominalnih bolečin/neugodja pri 12 tednih.
English: • urgency to pass stools
Slovenian: • nujna potreba po odvajanju blata
English: Intracellular cGMP causes secretion of chloride and bicarbonate into the intestinal lumen, through activation of the cystic fibrosis transmembrane conductance regulator (CFTR), which results in increased intestinal fluid and accelerated transit.
Slovenian: Znotrajcelični cGMP povzroči izločanje klorida in hidrogenkarbonata v črevesno svetlino z aktiviranjem transmembranskega regulatorja cistične fibroze (CFTR - cystic fibrosis transmembrane conductance regulator), kar poveča količino črevesne tekočine in pospeši prehod.
English: If you experience severe or prolonged diarrhoea (passing of frequent watery stools for 7 days or more), stop taking Constella and contact your doctor (see section 4).
Slovenian: V primeru hude ali dolgotrajne driske (pogosto izločanje vodenega blata, ki traja 7 dni ali več) prenehajte jemati zdravilo Constella in se posvetujte s svojim zdravnikom (glejte poglavje 4).
English: No dose adjustments are required for patients with hepatic or renal impairment (see section 5.2).
Slovenian: Odmerka za bolnike z okvaro jeter ali ledvic ni treba prilagajati (glejte poglavje 5.2).
English: 2% of treated patients experienced severe diarrhoea and 5% of patients discontinued treatment due to diarrhoea in clinical studies.
Slovenian: V kliničnih študijah je 2 % zdravljenih bolnikov imelo hudo drisko, 5 % bolnikov pa je zaradi driske prekinilo zdravljenje.
English: A food interaction clinical study in healthy subjects showed that linaclotide was not detectable in plasma either in fed or in fasted conditions at the therapeutic doses.
Slovenian: Klinična študija interakcije s hrano pri zdravih osebah je pokazala, da linaklotida pri terapevtskih odmerkih ni bilo mogoče zaznati v plazmi na poln želodec ali na tešče.
English: Stool consistency (BSFS Score)
Slovenian: Konsistenca blata (rezultat BSFS) Napor (5točkovna običajna lestvica)
English: Following a single oral dose of 2,897 micrograms linaclotide on day 8, after a 7-day course of 290 micrograms/day in 18 healthy volunteers, approximately 3 to 5% of the dose was recovered in the faeces, virtually all of it as the des-tyrosine active metabolite.
Slovenian: Po enem peroralnem odmerku 2.897 mikrogramov na 8. dan po 7-dnevnem ciklu dajanja 290 mikrogramov/dan 18 zdravim prostovoljcem so v blatu zaznali približno 3 do 5 % odmerka, skoraj v celoti v obliki aktivnega presnovka des-tirozina.
English: Taking Constella immediately after a high fat breakfast resulted in more frequent and looser stools, as well as more gastrointestinal adverse events, compared with taking it in the fasted state.
Slovenian: Jemanje zdravila Constella neposredno po zajtrku z visoko vsebnostjo maščob je povzročilo pogostejše odvajanje in redkejše blato ter več neželenih učinkov na črevesje, v primerjavi z jemanjem na tešče.
English: Linaclotide has been given orally to 1,166 patients with IBS-C in controlled clinical studies.
Slovenian: Linaklotid je bil dajan peroralno 1.166 bolnikom s sindromom razdražljivega črevesja z zaprtostjo v kontroliranih kliničnih študijah.
English: It is preferable to discuss stopping treatment with your doctor before actually doing so.
Slovenian: Najbolje je, da se pred dejanskim prenehanjem jemanja zdravila Constella o tem pogovorite s svojim zdravnikom.
English: Patients with known or suspected mechanical gastrointestinal obstruction.
Slovenian: Bolniki z znano mehanično obstrukcijo prebavil ali s sumom nanjo.
English: If you stop taking Constella
Slovenian: Če ste prenehali jemati zdravilo Constella
English: Linaclotide is rarely detectable in plasma following administration of the recommended clinical doses and in vitro studies have shown that linaclotide is neither a substrate nor an inhibitor/inducer of the cytochrome P450 enzyme system and does not interact with a series of common efflux and uptake transporters (see section 5.2).
Slovenian: Po uporabi priporočenega kliničnega odmerka se linaklotid v plazmi redko zazna, študije in vitro pa so pokazale, da linaklotid ni niti substrat niti inhibitor/induktor encimskega sistema citokroma P450 in ne stopa v interakcijo z vrsto običajnih izločevalnih in privzemnih prenašalcev (glejte poglavje 5.2).
English: Both linaclotide and its active metabolite bind to the GC-C receptor, on the luminal surface of the intestinal epithelium.
Slovenian: Linaklotid in njegov aktivni presnovek se vežeta na receptor GC-C na površini svetline črevesnega epitelija.
English: When 2,897 micrograms was administered on day 8, following a 7-day course of 290 micrograms/day, linaclotide was detectable in only 2 of 18 subjects at concentrations just above the lower limit of quantification of 0.2 ng/ml (concentrations ranged from 0.212 to 0.735 ng/ml).
Slovenian: Po odmerku 2.897 mikrogramov na 8. dan, ki je sledil 7-dnevnem ciklu uporabe 290 mikrogramov/dan, so linaklotid zaznali pri samo 2 od 18 oseb v koncentracijah, ki so malo nad mejo določljivosti, in je 0,2 ng/ml (koncentracije so bile v razponu od 0,212 do 0,735 ng/ml).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
Slovenian: Zdravilo Constella je indicirano pri odraslih za simptomatsko zdravljenje srednje hudega do hudega sindroma razdražljivega črevesja z zaprtostjo (IBS-C - irritable bowel syndrome with constipation).
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA TRGOVANJE Z ZDRAVILOM
English: Warning: The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry.
Slovenian: Opozorilo: Plastenka vsebuje eno ali več zatesnjenih vsebnikov s silikagelom, ki ohranja kapsule suhe.
English: • wind
Slovenian: • vetrovi
English: Linaclotide is rarely detectable in plasma, therefore, renal impairment would not be expected to affect clearance of the parent compound or its metabolite.
Slovenian: Linaklotid je v plazmi le redko zaznaven, zato ni pričakovati, da bi okvarjeno delovanje ledvic vplivalo na očistek prvotne spojine ali njenega presnovka.
English: Orthostatic hypotension
Slovenian: Žilne bolezni ortostatska hipotenzija
English: The efficacy of linaclotide was established in two randomised, double-blind, placebo-controlled Phase 3 clinical studies in patients with IBS-C.
Slovenian: Učinkovitost linaklotida je bila ugotovljena v dveh randomiziranih, dvojno slepih, s placebom kontroliranih kliničnih študijah 3. faze pri bolnikih s sindromom razdražljivega črevesja z zaprtostjo.
English: What Constella is used for
Slovenian: Za kaj se zdravilo Constella uporablja
English: In a cross-over food interaction study, 18 healthy subjects were administered Constella 290 micrograms for 7 days both in the fasting and fed state.
Slovenian: Pri navzkrižni študiji interakcij s hrano so 18 zdravim osebam 7 dni dajali zdravilo Constella 290 mikrogramov na poln želodec in na tešče.
English: Constella acts locally in your gut, helping you to feel less pain and less bloated, and to restore the normal functioning of your bowels.
Slovenian: Zdravilo Constella deluje lokalno v črevesju tako, da zmanjša občutek bolečine in napenjanje ter ponovno vzpostavi običajno delovanje črevesja.
English: Straining (5-point ordinal scale) *p<0.0001, linaclotide vs placebo.
Slovenian: *p < 0,0001, linaklotid v primerjavi s placebom.
English: Activation of GC-C results in an increase in concentrations of cyclic guanosine monophosphate (cGMP), both extracellularly and intracellularly.
Slovenian: Aktiviranje GC-C povzroči povečanje zunajceličnih in znotrajceličnih koncentracij cikličnega gvanozin monofosfata (cGMP).
English: Five percent of patients discontinued treatment due to diarrhoea in clinical studies.
Slovenian: Pri kliničnih preskušanjih je pet odstotkov bolnikov prekinilo zdravljenje zaradi driske.
English: White to off-white-orange opaque capsule (18 mm x 6.35 mm) marked “290” with grey ink.
Slovenian: FARMACEVTSKA OBLIKA trda kapsula bela do belkasta in oranžna neprozorna kapsula (18 mm x 6,35 mm) z oznako „290“ v sivem črnilu
English: Hypokalaemia Dehydration Decreased appetite
Slovenian: Presnovne in prehranske motnje hipokaliemija, dehidracija, zmanjšan apetit
English: Constella is available in packs containing 10, 28 or 90 capsules and in multipacks of 112 capsules comprising 4 cartons, each containing 28 capsules.
Slovenian: Zdravilo Constella je na voljo v pakiranjih, ki vsebujejo po 10, 28 ali 90 kapsul, in v velikih pakiranjih s 112 kapsulami, ki vsebujejo 4 plastenke s po 28 kapsulami.
English: Driving and using machines Constella will not affect your ability to drive or use machines
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Constella ne vpliva na sposobnost vožnje in upravljanja s stroji.
English: Constella should be used after organic diseases have been ruled out and a diagnosis of moderate to severe IBS-C (see section 5.1) is established.
Slovenian: Zdravilo Constella uporabite po izključitvi organskih bolezni in po postavitvi diagnoze zmerno hudega do hudega razdražljivega črevesja z zaprtjem (glejte poglavje 5.1).
English: Constella contains the active substance linaclotide.
Slovenian: Zdravilo Constella vsebuje zdravilno učinkovino linaklotid.
English: Caution should be used when co-administering Constella with such medications.
Slovenian: Pri sočasni uporabi zdravila Constella in tovrstnih zdravil je potrebna previdnost.
English: It is used to treat the symptoms of moderate to severe irritable bowel syndrome (often just called “IBS”) with constipation in adult patients.
Slovenian: Uporablja se za zdravljenje zmerno hudih do hudih simptomov razdražljivega črevesja (IBS - irritable bowel syndrome) z zaprtostjo pri odraslih bolnikih.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Slovenian: 2D črtna koda z enolično identifikacijsko oznako je priložena.
English: The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry.
Slovenian: Plastenka vsebuje eno ali več zatesnjenih vsebnikov s silikagelom, ki ohranja kapsule suhe.
English: • stomach or abdominal pain
Slovenian: • bolečina v želodcu ali trebuhu
English: - If you have any further questions, ask your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali farmacevtom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON CONTAINING SINGLE 28 CAPSULE BOTTLES (MULTIPACK) WITHOUT BLUE BOX
Slovenian: NOTRANJA ŠKATLA Z ENO PLASTENKO Z 28 KAPSULAMI (VELIKO PAKIRANJE) BREZ "BLUE BOX" PODATKOV
English: Taking Constella in the fed condition produced more frequent and looser stools, as well as more gastrointestinal adverse events, than when taking it under fasting conditions (see section 5.1).
Slovenian: Jemanje zdravila Constella na poln želodec je povzročilo pogostejše odvajanje in bolj mehko blato ter več neželenih učinkov na črevesje kot pri jemanju na tešče (glejte poglavje 5.1).
English: Each capsule contains 290 micrograms of linaclotide.
Slovenian: Ena kapsula vsebuje 290 mikrogramov linaklotida.
English: Linaclotide is metabolised locally within the gastrointestinal tract to its active primary metabolite, destyrosine.
Slovenian: Linaklotid se v prebavilih lokalno presnovi do svojega aktivnega primarnega presnovka, des-tirozina.
English: Constella produces more frequent bowel movements and diarrhoea (looser stools) when it is taken with food than when it is taken on an empty stomach (see section 3).
Slovenian: Zdravilo Constella lahko pri jemanju skupaj s hrano povzroči pogostejšo potrebo po iztrebljanju ali drisko (tekoče blato), kot če ga jemljete na prazen želodec (glejte poglavje 3).
English: Through its action at GC-C, linaclotide has been shown to reduce visceral pain and increase GI transit in animal models and increase colonic transit in humans.
Slovenian: Na živalskih modelih so dokazali, da delovanje linaklotida na GC-C zmanjša visceralne bolečine in poveča prehod skozi prebavila, pri ljudeh pa poveča prehod skozi debelo črevo.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Capsule shell: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatin.
Slovenian: Ovojnica kapsule: rdeči železov oksid (E172), titanov dioksid (E171), rumeni železov oksid (E172) in želatina.
English: • infrequent, hard, small or pellet-like stools (faeces).
Slovenian: • neredno odvajanje blata, trdo, majhno ali v kroglice oblikovano blato
English: White high density polyethylene (HDPE) bottle with a tamper evident seal and a child-resistant closure, together with one or more desiccant canisters containing silica gel.
Slovenian: Bela plastenka iz polietilena velike gostote (HDPE) s pečatom proti poseganju, z za otroke varnim pokrovčkom, skupaj z enim ali več vsebniki silikagela kot sredstva za sušenje.
English: Marketing Authorisation Holder Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
Slovenian: Imetnik dovoljenja za promet z zdravilom Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
English: Pack sizes: 10, 28 or 90 capsules and multipacks containing 112 (4 packs of 28) capsules.
Slovenian: Velikosti pakiranja: 10, 28 ali 90 kapsul ter večkratna pakiranja s 112 (4 pakiranja po 28) kapsulami.
English: Linaclotide is rarely detectable in plasma and is not metabolised by liver cytochrome P450 enzymes, therefore, hepatic impairment would not be expected to affect the metabolism or clearance of the parent drug or its metabolite.
Slovenian: Linaklotid je v plazmi le redko zaznaven, encimi jetrnega citokromskega sistema P450 pa ga ne presnavljajo, zato ni pričakovati, da bi okvara jeter vplivala na presnovo ali očistek prvotnega zdravila ali njegovega presnovka.
English: • bicarbonate decrease in your blood
Slovenian: • znižana raven hidrogenkarbonata v krvi
English: Printing ink: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, titanium dioxide (E171) and black iron oxide (E172).
Slovenian: Črnilo: šelak, propilenglikol, koncentrirana raztopina amoniaka, kalijev hidroksid, titanov dioksid (E171) in črni železov oksid (E172).
English: They are packaged in a white, high density polyethylene (HDPE) bottle with a tamper evident seal and a child-resistant screw cap, together with one or more desiccant canisters containing silica gel.
Slovenian: Pakirane so v beli plastenki iz polietilena velike gostote (HDPE) s pečatom proti poseganju in za otroke varno navojno zaporko, skupaj z enim ali več vsebniki silikagela kot sredstva za sušenje.
English: How to store Constella
Slovenian: Kako jemati zdravilo Constella
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON CONTAINING 4 x 28 CAPSULE BOTTLES (MULTIPACK) WITH BLUE BOX
Slovenian: ZUNANJA ŠKATLA S 4 PLASTENKAMI S PO 28 KAPSULAMI (VEČKRATNO PAKIRANJE) VKLJUČNO Z "BLUE BOX" PODATKI
English: EU/1/12/801/001 10 capsules EU/1/12/801/002 28 capsules EU/1/12/801/004 90 capsules
Slovenian: EU/1/12/801/001 10 kapsul EU/1/12/801/002 28 kapsul EU/1/12/801/004 90 kapsul
English: Constella 290 micrograms hard capsules linaclotide
Slovenian: Constella 290 mikrogramov trde kapsule linaklotid
English: NAME OF THE MEDICINAL PRODUCT Constella 290 micrograms hard capsules linaclotide
Slovenian: IME ZDRAVILA Constella 290 mikrogramov trde kapsule
English: EU/1/12/801/005 Multipack: 112 (4 packs of28) capsules
Slovenian: EU/1/12/801/005 Veliko pakiranje: 112 (4 pakiranja po 28) kapsul
English: How Constella works
Slovenian: Kako deluje zdravilo Constella
English: Of these patients, 892 patients received linaclotide at the recommended dose of 290 micrograms per day.
Slovenian: 892 od teh bolnikov je prejemalo linaklotid v priporočenemu odmerku 290 mikrogramov na dan. Celokupna izpostavitev v načrtu kliničnega razvoja je presegala 1.500 bolnikov-let.
English: For the 12 weeks data, study 1 shows that 39% of the patients treated with linaclotide compared with 17% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and 54% of the patients treated with linaclotide compared with 39% of the patients treated with placebo showed response to abdominal pain/discomfort (p<0.0001).
Slovenian: Podatki za 12 tednov v študiji 1 so pokazali, da je bila stopnja odziva olajšanja sindroma razdražljivega črevesja dosežena pri 39 % bolnikov, zdravljenih z linaklotidom, v primerjavi s 17 % bolnikov, zdravljenih s placebom (p < 0,0001), odziv olajšanja abdominalne bolečine/nelagodja pa pri 54 % bolnikov, zdravljenih z linaklotidom v primerjavi z 39 % bolnikov, zdravljenih s placebom (p<0,0001).
English: Red iron oxide (E172) Yellow iron oxide (E172)
Slovenian: Ovojnica kapsule titanov dioksid (E171) želatina rdeči železov oksid (E172) rumeni železov oksid (E172)
English: Constella has not been studied in patients who have renal impairment.
Slovenian: Uporabe zdravila Constella pri bolnikih z okvaro ledvic niso preučili.
English: Constella has not been studied in patients who have hepatic impairment.
Slovenian: Uporabe zdravila Constella pri bolnikih z okvaro jeter niso preučili.
English: Faecal incontinence Defecation urgency Lower gastrointestinal haemorrhage including haemorrhoidal haemorrhage and rectal haemorrhage Nausea
Slovenian: Bolezni prebavil driska abdominalne bolečine, flatulenca, abdominalna distenzija fekalna inkontinenca, urgentna defekacija, krvavenje iz spodnjih prebavil, vključno s krvavenjem hemeroidov in iz danke, navzea, bruhanje
English: Unopened bottle for 28, 90 and multipack containing 112 (4 packs of 28) capsules: 3 years.
Slovenian: V zaprti plastenki, ki vsebuje 28 ali 90 kapsul, oziroma v velikem pakiranju, ki vsebuje 112 kapsul (4 zavoji po 28): 3 leta.
English: By attaching to this receptor, it blocks the sensation of pain and allows liquid to enter from the body into the gut, thereby loosening the stools and increasing your bowel movements.
Slovenian: Zdravilo se ne absorbira v telo, temveč se veže na receptor na površini črevesja, imenovan gvanilat ciklaza C. Z vezavo na ta receptor zavre občutek bolečine in omogoči vstopanje tekočine iz telesa v črevesje ter s tem zmehča blato in poveča izločanje blata.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines: Some medicines may not work as effectively if you have severe or prolonged diarrhoea, such as: - Oral contraceptives.
Slovenian: Nekatera zdravila morda ne bodo delovala dovolj učinkovito, če imate hudo ali dolgotrajno drisko, na primer: - peroralna kontracepcijska sredstva.
English: They should be instructed to inform their physician if severe or prolonged diarrhoea or lower gastrointestinal bleeding occurs (see section 4.8).
Slovenian: Če se pojavi huda ali dolgotrajna driska ali krvavenje iz spodnjih prebavil, morajo o tem obvestiti zdravnika (glejte poglavje 4.8).
English: The recommended dose is one capsule (i.e. 290 micrograms of linaclotide) taken orally once a day.
Slovenian: Priporočeni odmerek je ena kapsula (tj. 290 mikrogramov linaklotida) peroralno enkrat na dan. Kapsulo vzemite vsaj 30 minut pred obrokom.
English: EU/1/12/801/004 90 capsules
Slovenian: EU/1/12/801/004 90 kapsul
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: peroralna uporaba POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom!
English: • feeling bloated
Slovenian: • občutek napenjanja
English: What Constella looks like and contents of the pack The capsules are white to off-white-orange opaque hard capsules marked “290” with grey ink.
Slovenian: Kapsule so bela do belkastoa in- oranžna , z oznako „290“ v sivem črnilu.