FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Nakon primjene jedne oralne doze od 2897 mikrograma linaklotida 8. dan, koja je uslijedila nakon 7 dana primjene 290 mikrograma dnevno u 18 zdravih dobrovoljaca, približno 3 do 5% doze je otkriveno u fecesu i to gotovo u potpunosti u obliku aktivnog metabolita des-tirozina.
English: No dose adjustments are required for patients with hepatic or renal impairment (see section 5.2).
Croatian: Nije potrebno prilagođavanje doza za bolesnike s oštećenjem funkcije bubrega ili jetre (vidjeti dio 5.2).
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.
Croatian: Constella je dostupna u pakiranjima od 10, 28 ili 90 kapsula, te u višestrukom pakiranju od 112 kapsula koje sadrži 4 kutije, a svaka sadrži 28 kapsula.
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.
Croatian: U dva glavna ispitivanja faze III u kojima je bolesnicima davana doza od 290 mikrograma linaklotida jedanput dnevno, linaklotid je detektiran u samo 2 od 162 bolesnika približno 2 sata nakon početne doze linaklotida (koncentracije su se kretale od 0,241 do 0,239 ng/ml), a nije detektiran niti u jednog od 162 bolesnika nakon 4 tjedna liječenja.
English: Straining (5-point ordinal scale) *p<0.0001, linaclotide vs placebo.
Croatian: *p< 0,0001, linaklotid naspram placeba.
English: Linaclotide has not been studied in patients with chronic inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis; therefore it is not recommended to use Constella in these patients.
Croatian: Linaklotid nije ispitivan u bolesnika s kroničnim upalnim stanjima intestinalnog trakta kao što su Crohnova bolest i ulcerozni kolitis te se, prema tome, ne preporučuje primjena Constelle u takvih bolesnika.
English: What Constella is used for
Croatian: Za što se Constella koristi
English: - Medicines to treat pain and inflammation called NSAIDs.
Croatian: - Lijekovi namijenjeni liječenju boli i upale pod nazivom nesteroidni protuupalni lijekovi.
English: Faecal incontinence Defecation urgency Lower gastrointestinal haemorrhage including haemorrhoidal haemorrhage and rectal haemorrhage Nausea
Croatian: Fekalna inkontinencija Urgencija defekacije Krvarenje iz donjeg gastrointestinalnog trakta, uključujući hemoroidalno krvarenje i krvarenje iz rektuma
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.
Croatian: Pokazalo se da linaklotid svojim djelovanjem na GC-C, smanjuje visceralnu bol, povećava gastrointestinalni prolazak u životinjskim modelima i povećava prolazak kroz kolon u ljudi.
English: Caution should be exercised when prescribing medicinal products absorbed in the intestinal tract with a narrow therapeutic index such as levothyroxine as their efficacy may be reduced.
Croatian: Pri propisivanju lijekova s uskim terapijskim indeksom koji se apsorbiraju u intestinalnom traktu, kao što je levotiroksin, mora se primijeniti oprez, jer njihova djelotvornost može biti smanjena.
English: The European Medicines Agency has deferred the obligation to submit the results of clinical studies with Constella in one or more subsets of the paediatric population in functional constipation (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja Constelle u jednoj ili više podskupina pedijatrijske populacije s funkcionalnim zatvorom.
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.
Croatian: Constellu se smije uzeti nakon što su isključene organske bolesti te je dijagnosticiran umjereni do teški oblik IBS-C-a (vidjeti dio 5.1).
English: • infrequent, hard, small or pellet-like stools (faeces).
Croatian: • neučestala, tvrda, mala količina stolice ili stolica u obliku kuglice.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING SINGLE BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA KOJA SADRŽI JEDNU BOCU
English: Unopened bottle for 28, 90 and multipack containing 112 (4 packs of 28) capsules: 3 years.
Croatian: Neotvorena boca s 28, 90 i višestruko pakiranje sa 112 (4 pakiranja od 28) kapsula: 3 godine.
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).
Croatian: Uzimanje Constelle nakon obroka rezultiralo je češćim i mekšim stolicama kao i sa više štetnih gastrointestinalnih događaja, nego kad se uzimala natašte (vidjeti dio 5.1).
English: Hypokalaemia Dehydration Decreased appetite
Croatian: Hipokalemija Dehidracija Smanjenje teka
English: Linaclotide is rarely detectable in plasma, therefore, renal impairment would not be expected to affect clearance of the parent compound or its metabolite.
Croatian: Linaklotid se rijetko detektira u plazmi, stoga se ne očekuje da oštećenje bubrega utiče na klirens ishodišne tvari ili njegovih metabolita.
English: Each capsule contains 290 micrograms of linaclotide.
Croatian: Svaka kapsula sadrži 290 mikrograma linaklotida.
English: Both linaclotide and its active metabolite bind to the GC-C receptor, on the luminal surface of the intestinal epithelium.
Croatian: Linaklotid i njegov aktivni metabolit se vežu za receptor gvanilat ciklaze-C (GC-C), na luminalnoj površini intestinalnog epitela.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOCA
English: Constella contains the active substance linaclotide.
Croatian: Constella sadrži djelatnu tvar linaklotid.
English: Once opened, use within 18 weeks.
Croatian: Nakon otvaranja, upotrijebiti u roku od 18 tjedana.
English: Warning: The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry.
Croatian: Upozorenje: Boca sadrži jedan ili više zatvorenih spremnika koji sadrže silikagel radi zaštite kapsula od vlage.
English: LS: Least Square CSBM: Complete Spontaneous Bowel Movement
Croatian: LS: Metoda najmanjih kvadrata (Least Square)
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.
Croatian: Bijela boca od polietilena visoke gustoće (HDPE) sa zaštitnom folijom s evidencijom otvaranja i sigurnosnim zatvaračem za djecu, zajedno s jednim ili više spremnika sa sredstvom za sušenje koji sadrže silikagel.
English: • bicarbonate decrease in your blood
Croatian: • smanjenje bikarbonata u krvi
English: Constella has not been studied in patients who have hepatic impairment.
Croatian: Constella nije ispitivana na bolesnicima s oštećenjem jetre.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON CONTAINING 4 x 28 CAPSULE BOTTLES (MULTIPACK) WITH BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA KOJA SADRŽI 4 BOCE PO 28 KAPSULA (VIŠESTRUKO PAKIRANJE) S PLAVIM OKVIROM
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.
Croatian: Kapsule su tvrde, neprozirne, bijele do bjelkasto-narančaste boje s oznakom „290“ otisnutom sivom tintom.
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.
Croatian: Pakirane su u bijele boce od polietilena visoke gustoće (HDPE) sa zaštitnom folijom s evidencijom otvaranja i sigurnosnim zatvaračem za djecu, zajedno s jednim ili više spremnika sa sredstvom za sušenje koji sadrže silikagel.
English: The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry.
Croatian: Boca sadrži jedan ili više zatvorenih spremnika koji sadrže silikagel radi zaštite kapsula od vlage.
English: Capsule shell: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatin.
Croatian: Ovojnica kapsule: crveni željezov oksid (E172), titanijev dioksid (E171), žuti željezov oksid (E172) i želatina.
English: Stool consistency (BSFS Score)
Croatian: Konzistencija stolice (BSFS rezultat) Naprezanje (Ordinalna ljestvica s 5 bodova)
English: Diarrhoea is normally short lived; however, if you experience severe or prolonged diarrhoea (passing frequent or watery stools for 7 days or more) and feel lightheaded, dizzy or faint, stop taking Constella and contact your doctor.
Croatian: Međutim, ako iskusite teški ili produljeni proljev (česta ili vodenasta stolica u trajanju od 7 dana ili dulje) te se osjećate ošamućeni, imate omaglicu ili nesvjesticu, prestanite uzimati Constellu i obratite se svom liječniku.
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.
Croatian: Zajednička primarna mjera ishoda u oba klinička ispitivanja je stopa bolesnika s odgovorom s obzirom na stupanj olakšanja IBS-a i stopa bolesnika s odgovorom s obzirom na bolove/nelagodu u abdomenu u trajanju od 12 tjedana.
English: Pack sizes: 10, 28 or 90 capsules and multipacks containing 112 (4 packs of 28) capsules.
Croatian: Veličina pakiranja: 10, 28, ili 90 kapsula, te višestruko pakiranje koje sadrži 112 (4 pakiranja s 28) kapsula.
English: EU/1/12/801/005 Multipack: 112 (4 packs of28) capsules
Croatian: EU/1/12/801/005 Višestruko pakiranje: 112 (4 pakiranja s 28) kapsula
English: Constella has not been studied in patients who have renal impairment.
Croatian: Constella nije ispitivana na bolesnicima s oštećenjem bubrega.
English: For the 26 weeks data, study 1 shows that 37% and 54% of the patients treated with linaclotide compared with 17% and 36% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and abdominal pain/discomfort (p<0.0001) respectively.
Croatian: Iz podataka prikupljenih u periodu od 26 tjedana, ispitivanje 1 je pokazalo da je 37% i 54% bolesnika liječenih linaklotidom u usporedbi sa 17% i 36% bolesnika liječenih placebom pokazalo odgovor s obzirom na stupanj olakšanja IBS-a (p< 0,0001) odnosno s obzirom na bol/nelagodu u trbuhu (p< 0,0001).
English: Constella 290 micrograms hard capsules linaclotide
Croatian: Constella 290 mikrograma tvrde kapsule linaklotid
English: • urgency to pass stools
Croatian: • hitnost pražnjenja stolice
English: The recommended dose is one capsule (i.e. 290 micrograms of linaclotide) taken orally once a day.
Croatian: Preporučena doza je jedna kapsula (tj. 290 mikrograma linaklotida) jedanput na dan kroz usta.
English: EU/1/12/801/001 10 capsules EU/1/12/801/002 28 capsules EU/1/12/801/004 90 capsules
Croatian: EU/1/12/801/001 10 kapsula EU/1/12/801/002 28 kapsula EU/1/12/801/004 90 kapsula
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON CONTAINING SINGLE 28 CAPSULE BOTTLES (MULTIPACK) WITHOUT BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA KOJA SADRŽI JEDNU BOCU S 28 KAPSULA (VIŠESTRUKO PAKIRANJE)
English: Very common side effects (may affect more than 1 in 10 people):
Croatian: Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba):
English: Fig 2.
Croatian: PRILOG II.
English: • stomach or abdominal pain,
Croatian: • bol u želucu ili trbuhu,
English: It is preferable to discuss stopping treatment with your doctor before actually doing so.
Croatian: Preporučuje se razgovarati sa svojim liječnikom u slučaju da želite prekinuti liječenje.
English: Study 2 shows that 37% of the patients treated with linaclotide compared with 19% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and 55% of the patients treated with linaclotide compared with 42% of the patients treated with placebo showed response to abdominal pain/discomfort (p=0.0002).
Croatian: je pokazalo da je 37% bolesnika liječenih linaklotidom u usporedbi s 19% bolesnika liječenih placebom pokazalo odgovor s obzirom na stupanj olakšanja IBS-a (p< 0,0001), dok je 55% bolesnika liječenih linaklotidom u usporedbi s 42% bolesnika liječenih placebom pokazalo odgovor s obzirom na bolove/nelagodu u abdomenu (p= 0,0002).
English: Printing ink: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, titanium dioxide (E171) and black iron oxide (E172).
Croatian: Tinta za označavanje: šelak, propilenglikol, koncentrirana otopina amonijaka, kalijev hidroksid, titanijev dioksid (E171) i crni željezov oksid (E172).
English: 2% of treated patients experienced severe diarrhoea and 5% of patients discontinued treatment due to diarrhoea in clinical studies.
Croatian: U kliničkim ispitivanjima, 2% liječenih bolesnika je imalo teški oblik proljeva, a 5% bolesnika je prekinulo liječenje zbog proljeva.
English: • feeling bloated,
Croatian: • osjećaj nadutosti,
English: • feeling bloated
Croatian: • osjećaj omaglice
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/801/005 Multipack: 112 (4 packs of 28) capsules 13.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/801/005 Višestruko pakiranje: 112 (4 pakiranja s 28) kapsula 13. BROJ SERIJE
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).
Croatian: Iz podataka prikupljenih u periodu od 12 tjedana, ispitivanje 1 je pokazalo da je 39% bolesnika liječenih linaklotidom u usporedbi sa 17% bolesnika liječenih placebom pokazalo odgovor s obzirom na stupanj olakšanja IBS-a (p< 0,0001), dok je 54% bolesnika liječenih linaklotidom u usporedbi s 39% bolesnika liječenih placebom pokazalo odgovor s obzirom na bolove/nelagodu u abdomenu (p< 0,0001).
English: Multipack : 112 (4 packs of 28) capsules 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
Croatian: Višestruko pakiranje: 112 (4 pakiranja s 28) kapsula NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: Red iron oxide (E172) Yellow iron oxide (E172)
Croatian: željezov oksid, crni (E172)
English: Rare side effects (may affect up to 1 in 1,000 people):
Croatian: Rijetke nuspojave (mogu se javiti kod do 1 na 1000 osoba):
English: Five percent of patients discontinued treatment due to diarrhoea in clinical studies.
Croatian: U kliničkim ispitivanjima, 5% bolesnika je prekinulo liječenje radi proljeva.
English: NAME OF THE MEDICINAL PRODUCT Constella 290 micrograms hard capsules linaclotide
Croatian: NAZIV LIJEKA Constella 290 mikrograma tvrde kapsule
English: EU/1/12/801/004 90 capsules
Croatian: EU/1/12/801/004 90 kapsula
English: How to take Constella
Croatian: Kako uzimati Constellu
English: What you need to know before you take Constella Do not take Constella - if you are allergic to linaclotide or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Constellu - ako ste alergični na linaklotid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako Vi ili Vaš liječnik znate da imate zastoj u želucu ili crijevima.
English: EU/1/12/801/001 10 capsules
Croatian: EU/1/12/801/001 10 kapsula
English: EU/1/12/801/002 28 capsules
Croatian: EU/1/12/801/002 28 kapsula
English: Capsule ink
Croatian: 90 kapsula
English: Blood bicarbonate decreased
Croatian: Smanjenje bikarbonata u krvi
English: • stomach or abdominal pain
Croatian: • bol u želucu ili trbuhu
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave (mogu se javiti kod do 1 na 100 osoba):
English: Name and address of the manufacturer responsible for batch release Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
English: Common side effects (may affect up to 1 in 10 people):
Croatian: Česte nuspojave (mogu se javiti kod do 1 na 10 osoba):
English: Capsule contents
Croatian: Tvrda kapsula
English: Tel: + 385 1 6646 563
Croatian: Ewopharma d.o.o. Tel: + 385 1 6646 563
English: Tel: + 48 22 256 37 00
Croatian: Allergan Sp. z o.o. Tel: + 48 22 256 37 00
English: How to store Constella
Croatian: Kako čuvati Constellu
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.
Croatian: P450, stoga se ne očekuje da oštećenje jetre utječe na metabolizam ili klirens ishodišnog lijeka ili njegovih metabolita.
English: Very common Common Uncommon
Croatian: Vrlo često Često
English: Propylene glycol Concentrated ammonia solution Potassium hydroxide Titanium dioxide (E 171) Black iron oxide (E172)
Croatian: Tinta za označavanje kapsule šelak propilenglikol koncentrirana otopina amonijaka kalijev hidroksid titanijev dioksid (E171)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 290 micrograms of linaclotide
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka kapsula sadrži 290 mikrograma linaklotida.
English: • rectal bleeding
Croatian: • krvarenje iz rektuma
English: Change from baseline Mean
Croatian: Promjena od početne Srednja vrijednost
English: Marketing Authorisation Holder Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
English: Magyarország Allergan Hungary Kft. Tel.: + 36 80 100 101
Croatian: Tel.: + 36 80 100 101
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: Početno Srednja vrijednost
English: Sími: + 354 550 3300
Croatian: Actavis Pharmaceuticals Iceland ehf. Sími: + 354 550 3300
English: Other medicines and Constella
Croatian: OZNAČIVANJE I UPUTA O LIJEKU
English: Talk to your doctor if you experience bleeding from the bowel or rectum.
Croatian: Ako imate krvarenje iz crijeva ili rektuma, obratite se svome liječniku.
English: • decreased appetite
Croatian: • osjećaj nadutosti
English: EU/1/12/801/001 EU/1/12/801/002 EU/1/12/801/004 EU/1/12/801/005
Croatian: EU/1/12/801/005
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
Croatian: Primjena kroz usta POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: --1 Live aroA gene deleted Escherichia coli, type O78, strain EC34195 - 5.2x106 - 9.1x108 CFU* * Colony forming units when grown on tryptic soy agar plates.
Croatian: --1 Živi aroA gen deletirane Escherichia coli, tip O78, soj EC34195 - 5,2 x 106 do 9,1 x 108 CFU *Jedinica tvorbe kolonija (colony forming units) kada se uzgaja na tripton soja agar podlogama
English: EU (MA) number
Croatian: 5000doz a
English: Invented name
Croatian: 10 bočica Nuladana
English: 12 (3 x 4) pre-filled pens (multipack)
Croatian: 12 (3 x 4) napunjenih štrcaljki (višestruko pakiranje)
English: If you need to have an operation:
Croatian: Ako morate ići na operaciju:
English: Please keep this card with you at all times.
Croatian: Molimo Vas da uvijek nosite ovu karticu sa sobom.
English: 0.004 (for superiority)
Croatian: 0,004 (za superiornost)
English: WHEN TO SEEK MEDICAL ADVICE
Croatian: KADA ZATRAŽITI SAVJET LIJEČNIKA
English: Experience with overdose cases is very limited.
Croatian: Iskustvo sa slučajevima predoziranja vrlo je ograničeno.
English: Please talk to your doctor if you experience any unusual symptoms.
Croatian: Molimo da se obratite svom liječniku ako osjetite ikakve neobične simptome.
English: The formula is as follows:
Croatian: Formula je bila sljedeća:
English: n Number of Events
Croatian: n Broj događaja
English: If you are taking any of the following:
Croatian: Ako uzimate nešto od sljedećeg:
English: Note: A subject can be included in multiple sub-categories if he/she had an event for those categories.
Croatian: Napomena: Ispitanik može biti uključen u više podkategorija ako je imao događaj u tim kategorijama.
English: The first event of each category is included in the analysis.
Croatian: Prvi događaj u pojedinoj kategoriji uključen je u analizu.
English: • Use of coagulation tests and their interpretation
Croatian: • uporaba testova koagulacije i njihovo tumačenje
English: This was not considered clinically significant.
Croatian: To se nije smatralo klinički značajnim.
English: In some cases the bleeding may not be obvious.
Croatian: U nekim slučajevima krvarenje ne mora biti vidljivo.
English: 5 years
Croatian: 50 godina.
English: The absolute bioavailability is approximately 62%.
Croatian: Apsolutna bioraspoloživost je približno 62%.
English: PVC/Aluminium blisters.
Croatian: PVC/aluminij blisteri.
English: If you take more Roteas than you should
Croatian: Ako uzmete više Roteasa nego što ste trebali
English: In case of clinically significant bleeding, stop treatment immediately.
Croatian: U slučaju klinički značajnog krvarenja, odmah obustavite liječenje.
English: • rifampicin, an antibiotic
Croatian: • rifampicin, antibiotik.
English: Exposure to the other metabolites is less than 5%.
Croatian: Izloženost drugim metabolitima manja je od 5%.
English: In vitro plasma protein binding is approximately 55%.
Croatian: In vitro vezanje za proteine plazme je približno 55%.
English: • Anaemia (low levels of red blood cells)
Croatian: • anemija (nizak broj crvenih krvnih stanica)
English: It is therefore important to be aware of the possible signs and symptoms of bleeding and to speak to your doctor immediately if you experience any of the following:
Croatian: Stoga je važno da budete upoznati s mogućim znakovima i simptomima krvarenja i da se odmah obratite svom liječniku ako Vam se pojavi nešto od sljedećeg:
English: 1 Reporting rates are based on the female population in clinical trials.
Croatian: 1 Stope prijava temelje se na ženskoj populaciji u kliničkim ispitivanjima.
English: - if you have a mechanical heart valve
Croatian: - ako imate mehanički srčani zalistak
English: Ethnic origin
Croatian: Etničko porijeklo
English: What Roteas is and what it is used for
Croatian: Što je Roteas i za što se koristi
English: • Relevant information on the risk of bleeding
Croatian: • relevantne informacije o riziku od krvarenja
English: It is very important to take Roteas before and after the operation exactly at the times you have been told by your doctor.
Croatian: Jako je važno da uzmete Roteas prije i poslije operacije točno u vrijeme kada Vam je odredio liječnik.
English: • Vomiting blood or material that looks like ground coffee
Croatian: • povraćanje krvi ili sadržaja koji izgleda kao mljevena kava
English: Food increases peak exposure to a varying extent, but has minimal effect on total exposure.
Croatian: Hrana povećava vršnu izloženost u različitoj mjeri, ali ima minimalni učinak na ukupnu izloženost.