FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of this low inhibitory activity and the low plasma levels at therapeutic doses (average of 26 ng/ml and 108 ng/ml respectively), these metabolites are considered to be pharmacologically inconsequential.
Croatian: S obzirom na tu nisku inhibicijsku aktivnost i nisku razinu u plazmi u terapijskim dozama (prosječno 26 ng/ml, odnosno 108 ng/ml), ti se metaboliti ne smatraju farmakološki značajnim.
English: If orlistat is taken with a meal very high in fat, the possibility of gastrointestinal adverse reactions may increase.
Croatian: Ako se orlistat uzima uz visokomasni obrok, može se povećati mogućnost pojave gastrointestinalnih nuspojava.
English: The usual dose of Xenical is one 120 mg capsule taken with each of the three main meals per day.
Croatian: Uobičajena doza lijeka Xenical je jedna kapsula od 120 mg uz svaki od tri glavna obroka dnevno.
English: When warfarin or other anticoagulants are given in combination with orlistat, international normalised ratio (INR) values should be monitored (see section 4.4).
Croatian: Kad se varfarin ili drugi antikoagulansi daju u kombinaciji s orlistatom, potrebno je nadzirati vrijednosti internacionalnog normaliziranog omjera (INR, engl. international normalised ratio) (vidjeti dio 4.4) .
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 July 1998
Croatian: Datum prvog odobrenja: 29. srpnja 1998.
English: The possibility of this happening may increase if Xenical is taken with a diet high in fat.
Croatian: Mogućnost da se to dogodi povećava se ako se Xenical uzima istovremeno s hranom bogatom mastima.
English: Hepatitis (inflammation of the liver).
Croatian: Hepatitis (upala jetre).
English: Taking Xenical during pregnancy is not recommended.
Croatian: Ne preporučuje se uzimanje lijeka Xenical tijekom trudnoće.
English: Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ml) eight hours following oral administration of orlistat.
Croatian: Koncentracija nepromijenjenog orlistata u plazmi nije se mogla odrediti (< 5 ng/ml) osam sati nakon peroralne primjene orlistata.
English: This risk is increased in patients with underlying chronic kidney disease and/or volume depletion (see section 4.8).
Croatian: Taj je rizik povećan u bolesnika s podležećom kroničnom bolešću bubrega i/ili deplecijom volumena (vidjeti dio 4.8).
English: INFORMATION IN BRAILLE xenical
Croatian: 16. PODACI NA BRAILLEOVOM PISMU xenical
English: There are some case reports of reduced efficacy of antiretroviral HIV medicines, antidepressants antipsychotics (including lithium) and benzodiazepines coincidental to the initiation of orlistat treatment in previously well-controlled patients.
Croatian: Postoji nekoliko izvješća o slučajevima smanjene djelotvornosti antiretrovirusnih lijekova za liječenje infekcije HIV-om, antidepresiva, antipsihotika (uključujući litij) i benzodiazepina koja se podudaraju sa započinjanjem primjene orlistata u bolesnika koji su do tada bili dobro regulirani.
English: Weight loss may also affect the dose of medicines taken for other conditions (e.g. high cholesterol or diabetes).
Croatian: Upozorenja i mjere opreza Gubitak težine može utjecati na potrebnu dozu lijekova koji se uzimaju za druge bolesti (npr. visoki kolesterol ili šećernu bolest).
English: In a multi-centre (US, Canada), parallel-group, double-blind, placebo-controlled study, 539 obese adolescent patients were randomised to receive either 120 mg orlistat (n=357) or placebo (n=182) three times daily as an adjunct to a hypocaloric diet and exercise for 52 weeks.
Croatian: U multicentričnom (SAD, Kanada), s paralelnim grupama, dvostruko slijepom, placebom kontroliranom ispitivanju, 539 pretilih bolesnika adolescenata randomizirano je da bi tijekom 52 tjedna tri puta dnevno primili 120 mg orlistata (n=357) ili placebo (n=182) uz hipokalorijsku dijetu i vježbanje.
English: The majority of orlistat overdose cases received during post-marketing reported either no adverse events or adverse events that are similar to those reported with recommended dose.
Croatian: većini prijavljenih slučajeva predoziranja orlistatom u razdoblju nakon stavljanja lijeka u promet nisu prijavljene nikakve nuspojave ili su prijavljene nuspojave bile slične onima za vrijeme uzimanja lijeka u preporučenoj dozi.
English: Patients should be advised to adhere to the dietary recommendations they are given (see section 4.2).
Croatian: Bolesnicima treba savjetovati da se strogo pridržavaju savjeta o prehrani (vidjeti dio 4.2 ).
English: The disposition of orlistat appeared to be similar between normal weight and obese volunteers.
Croatian: Dispozicija orlistata činila se jednakom u dobrovoljaca normalne težine kao i u onih pretilih.
English: Co-administration with ciclosporin is not recommended.
Croatian: Ne preporučuje se istovremena primjena sa ciklosporinom.
English: The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug-drug interaction studies.
Croatian: Odsutnost interakcija između oralnih kontraceptiva i orlistata dokazana je u specifičnim studijama interakcija lijek-lijek.
English: Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m², or overweight patients (BMI > 28 kg/m²) with associated risk factors.
Croatian: Xenical je u kombinaciji s blago hipokalorijskom dijetom indiciran za liječenje pretilih bolesnika kojima je indeks tjelesne mase (BMI = Body Mass Index) 30 kg/m² ili veći, kao i u bolesnika s prekomjernom tjelesnom težinom (BMI ≥ 28 kg/m²) i pridruženim faktorima rizika.
English: Skin blistering (including blisters that burst).
Croatian: Kožni mjehurići (uključujući mjehuriće koji pucaju).
English: This medicine can cause harmless changes in your bowel habits, such as fatty or oily stools, due to the elimination of undigested fat in your faeces.
Croatian: Ovaj lijek može izazvati bezazlene promjene u radu crijeva, poput masne ili uljne stolice, zbog uklanjanja neprobavljene masti stolicom.
English: If you forget to take XENICAL
Croatian: Ako ste zaboravili uzeti XENICAL
English: Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal.
Croatian: Ispitivanja provedena na dobrovoljcima normalne težine i pretilima pokazala su da je opseg apsorpcije orlistata minimalan.
English: Oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).
Croatian: Oksalatna nefropatija (nakupljanje kalcijevog oksalata, što može dovesti do stvaranja bubrežnih kamenaca).
English: Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K).
Croatian: Vitamini topivi u masti Liječenje orlistatom može potencijalno smanjiti apsorpciju vitamina topivih u masti (A, D, E i K).
English: Increases in the levels of some liver enzymes may be found in blood tests.
Croatian: U krvnim nalazima mogu se naći povećane razine nekih jetrenih enzima.
English: In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 ng/ml or 0.02 µmol), with no evidence of accumulation, which is consistent with minimal absorption.
Croatian: Općenito, pri terapijskim dozama je pojava nepromijenjenog orlistat u plazmi bila sporadična, i u iznimno malim koncentracijama (< 10 ng/ml ili 0,02 µmol), bez znakova nakupljanja, što je u skladu s minimalnom apsorpcijom.
English: You must not breast-feed your infant during treatment with Xenical as it is not known whether Xenical passes into human milk.
Croatian: Tijekom terapije lijekom Xenical ne smijete dojiti dijete jer nije poznato izlučuje li se Xenical u majčino mlijeko.
English: As it is not known whether orlistat is secreted into human milk, orlistat is contra-indicated during breast-feeding.
Croatian: Kako nije poznato izlučuje li se u majčino mlijeko, orlistat je kontraindiciran tijekom dojenja.
English: The mean difference in weight loss with the drug compared to placebo was 3.2 kg.
Croatian: Srednja razlika u gubitku težine uz lijek u odnosu na placebo iznosila je 3,2 kg.
English: The majority of unwanted effects related to the use of Xenical result from its local action in your digestive system.
Croatian: Većina nuspojava vezanih uz upotrebu lijeka Xenical proizlazi iz njegovog lokalnog djelovanja u probavnom sustavu.
English: 42 hard capsules
Croatian: 42 tvrde kapsule
English: In a 4 year clinical trial, the general pattern of adverse event distribution was similar to that reported for the 1 and 2 year studies with the total incidence of gastrointestinal related adverse events occurring in year 1 decreasing year on year over the four year period.
Croatian: U četverogodišnjem kliničkom ispitivanju opći obrazac distribucije štetnih događaja bio je sličan onome u jednogodišnjim i dvogodišnjim ispitivanjima, pri čemu se ukupna incidencija štetnih događaja vezanih uz gastrointestinalni sustav koji su se javili u prvoj godini smanjivala iz godine u godinu tijekom četverogodišnjeg razdoblja.
English: Studies in normal weight and obese subjects have shown that faecal excretion of the unabsorbed drug was the major route of elimination.
Croatian: Ispitivanja na osobama normalne težine i pretilim osobama pokazala su da je izlučivanje neapsorbiranog lijeka u stolici glavni put eliminacije.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: In the absence of pharmacokinetic interaction studies, the concomitant administration of orlistat with acarbose should be avoided.
Croatian: U nedostatku studija farmakokinetičkih interakcija treba izbjegavati istovremenu primjenu orlistata i akarboze.
English: Store in original package and keep the blister in the outer carton in order to protect from light and moisture.
Croatian: Čuvati u originalnom pakiranju i čuvati blister u vanjskom pakiranju radi zaštite od svjetlosti i vlage.
English: In the 2-year studies and the 4-year study, a hypocaloric diet was used in association with treatment in both the orlistat and the placebo treated groups.
Croatian: U dvogodišnjim studijama i četverogodišnjoj studiji, hipokalorijska dijeta je korištena u skupinama koje su primale terapiju orlistatom kao i u skupinama koje su primale placebo.
English: Antiretrovirals for HIV: Orlistat may potentially reduce the absorption of antiretroviral medicines for HIV and could negatively affect the efficacy of antiretroviral medications for HIV (see section 4.5).
Croatian: Antiretrovirusni lijekovi za liječenje infekcije HIV-om: Orlistat može potencijalno smanjiti apsorpciju antiretrovirusnih lijekova za liječenje infekcije HIV-om i može negativno utjecati na djelotvornost antiretrovirusnih lijekova za liječenje infekcije HIV-om (vidjeti dio 4.5).
English: Please contact your doctor if you think that the frequency and/or severity of the convulsions have changed when taking Xenical together with antiepileptic drugs.
Croatian: Obavijestite svog liječnika ukoliko mislite da primjena lijeka Xenical zajedno s antiepilepticima mijenja učestalost i/ili težinu konvulzija.
English: The capsule has a turquoise cap and turquoise body bearing the imprint of “XENICAL 120”.
Croatian: Kapsula ima tirkiznu kapicu i tirkizno tijelo s natpisom "XENICAL 120".
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.
Croatian: Neklinički podaci iz konvencionalnih ispitivanja farmakološke sigurnosti, toksičnosti ponovljene doze, genotoksičnosti, karcinogenog potencijala ili reproduktivne toksičnosti, ne ukazuju na poseban rizik za ljude.
English: Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of therapy.
Croatian: Liječenje orlistatom treba prekinuti nakon 12 tjedana ako bolesnik ne uspije izgubiti barem 5% tjelesne težine izmjerene na početku terapije.
English: For orlistat no clinical data on exposed pregnancies are available.
Croatian: Nema kliničkih podataka o primjeni orlistata tijekom trudnoće.
English: Your doctor may need to monitor your ciclosporin blood levels more frequently than usual.
Croatian: Liječnik će možda morati češće pratiti razinu ciklosporina u krvi.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000) including isolated reports.
Croatian: Učestalosti su definirane na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1,000 i <1/100), rijetko
English: Xenical only works in the presence of dietary fat.
Croatian: Xenical djeluje samo na prehrambene masti.
English: Xenical should be taken with a well-balanced, calorie controlled diet that is rich in fruit and vegetables and contains an average of 30 % of the calories from fat.
Croatian: Xenical treba uzimati uz uravnoteženu prehranu bogatu voćem i povrćem s kontroliranim unosom kalorija koja sadrži prosječno 30% kalorija iz masti.
English: Children Xenical is not intended to be used in children.
Croatian: Xenical nije namijenjen primjeni kod djece.
English: Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite.
Croatian: Simptomi mogu uključivati žutilo kože i očiju, svrbež, tamnu boju mokraće, bol u trbuhu i osjetljivost jetre (bol ispod prednjeg rebrenog luka s desne strane), ponekad praćene gubitkom teka.
English: The reason for this difference is that the five 2-year studies included a 4-week diet and placebo lead-in period during which patients lost on average 2.6 kg prior to commencing treatment.
Croatian: Uzrok je toj razlici što je u pet dvogodišnjih studija obuhvaćeno uvodno razdoblje četverotjedne dijete uz liječenje placebom, tijekom kojeg su bolesnici u prosjeku izgubili 2,6 kg prije početka samog liječenja.
English: • Iodine salts and/or levothyroxine.
Croatian: • soli joda i/ili levotiroksina.
English: Adverse reaction/event
Croatian: Nuspojava/ štetan događaj
English: The effect of orlistat in patients with hepatic and/or renal impairment, children and elderly patients has not been studied.
Croatian: Nije ispitan učinak orlistata u bolesnika s oštećenom jetrenom i/ili bubrežnom funkcijom, djece i starijih bolesnika.
English: The use of orlistat may be associated with renal stones in patients suffering from chronic kidney disease.
Croatian: Primjena orlistata može biti povezana s nastankom bubrežnih kamenaca u bolesnika koji boluju od kronične bolesti bubrega.
English: It can be taken immediately before, during a meal or up to one hour after a meal.
Croatian: Možete ju uzeti neposredno prije, tijekom ili unutar jednog sata nakon obroka.
English: In clinical trials, the decrease in bodyweight with orlistat treatment was less in type II diabetic patients than in non-diabetic patients.
Croatian: U kliničkim ispitivanjima orlistata, smanjenje tjelesne težine bilo je manje u bolesnika s dijabetesom tipa II nego u bolesnika koji nisu bolovali od dijabetesa.
English: The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30 % of calories from fat.
Croatian: Bolesnik mora biti na uravnoteženoj, umjereno hipokalorijskoj prehrani, otprilike 30% kalorija unešenih hranom trebaju biti iz masti.
English: Orlistat, M1 and M3 are all subject to biliary excretion.
Croatian: Orlistat, M1 i M3,
English: Glass bottles with desiccant containing 21, 42 and 84 hard capsules.
Croatian: Staklene boce sa sredstvom za sušenje koje sadrže 21, 42 i 84 tvrde kapsule.
English: In patients receiving concomitant amiodarone treatment, reinforcement of clinical and ECG monitoring is warranted.
Croatian: U bolesnika istovremeno liječenih amiodaronom preporučuje se pojačano praćenje kliničke slike i EKG-a.
English: Co-administration of orlistat with ciclosporin is not recommended (see section 4.5).
Croatian: Ne preporučuje se istodobno davanje orlistata sa ciklosporinom (vidjeti dio 4.5.).
English: However, there was an unexplained increase in the incidence of bone fractures (6 % versus 2.8 % in the orlistat and placebo groups, respectively).
Croatian: No, došlo je do neobjašnjenog porasta učestalosti pojave prijeloma kostiju (6 % u skupinama koje su primale orlistat u odnosu na 2,8 % u skupinama koje su primale placebo).
English: - Cholestasis.
Croatian: - Kolestaza.
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time
Croatian: Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
English: Based on a study in obese patients, of the minimal fraction of the dose that was absorbed systemically, two major metabolites, M1 (4-member lactone ring hydrolysed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42 % of the total plasma concentration.
Croatian: Na temelju ispitivanja pretilih osoba, od minimalne frakcije doze koja se sistemski apsorbira, dva glavna metabolita, M1 (nastaje hidrolizom laktonskog prstena na položaju 4) i M3 (M1 s odcijepljenim N-formil leucinskim ostatkom) iznose 42 % ukupne koncentracije u plazmi.
English: Orlistat may unbalance an anticonvulsivant treatment, by decreasing the absorption of antiepileptic drugs, thus leading to convulsions.
Croatian: Orlistat može narušiti ravnotežu antikonvulzivne terapije, smanjenjem apsorpcije antiepileptika, što dovodi do konvulzija.
English: The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
Croatian: Dnevni unos masti, ugljikohidrata i proteina treba biti raspoređen na tri glavna obroka.
English: However, if such concomitant use is unavoidable, more frequent monitoring of ciclosporin blood levels should be performed both after addition of orlistat and upon discontinuation of orlistat in ciclosporin treated patients.
Croatian: Ako je, međutim, takva istodobna primjena neizbježna, u bolesnika liječenih ciklosporinom valja češće pratiti razine ciklosporina u krvi, i nakon početka i nakon prestanka uzimanja orlistata.
English: Xenical capsules are turquoise with the imprint “XENICAL 120” and are supplied in blister packs and glass bottles, containing 21, 42 and 84 capsules.
Croatian: Xenical kapsule tirkizne su boje s natpisom "XENICAL 120", a dostupne su u blister pakiranjima i staklenim bocama sa 21,42 i 84 kapsule.
English: The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine (see section 4.4).
Croatian: Mehanizam, iako nije dokazan, može uključivati smanjenu apsorpciju soli joda i/ili levotiroksina (vidjeti dio 4.4).
English: Very common: Headache Respiratory, thoracic and mediastinal disorders Very common:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 120 mg orlistat.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 120 mg orlistata.
English: Bleeding from the back passage (rectum).
Croatian: Krvarenje iz završnog dijela crijeva (rektuma).
English: Your daily intake of fat, carbohydrate and protein should be distributed over three meals.
Croatian: Vaš dnevni unos masti, ugljikohidrata i proteina treba biti raspoređen na tri glavna obroka.
English: The following table of undesirable effects (first year of treatment) is based on adverse events that occurred at a frequency of > 2 % and with an incidence ≥ 1 % above placebo in clinical trials of 1 and 2 years duration:
Croatian: Sljedeća tablica nuspojava (prva godina liječenja) prikazuje štetne događaje koji su se pojavili s učestalošću > 2 % i s incidencijom ≥ 1 % u odnosu na placebo u kliničkim ispitivanjima u trajanju od 1 i 2 godine:
English: The capsule shell consists of gelatine, indigo carmine (E132), titanium dioxide (E171) and edible printing ink.
Croatian: Ovojnica kapsule se sastoji od želatine, indigo karmina (E132), titanijevog dioksida (E171) i jestive tinte za označavanje.
English: The difference was driven by the outcome in the group of patients with ≥ 5 % weight loss after 12 weeks of treatment with orlistat representing 19 % of the initial population.
Croatian: Na razliku su značajno utjecali rezultati u skupini bolesnika s gubitkom tjelesne težine od ≥ 5% nakon 12 tjedana liječenja orlistatom, koji su predstavljali 19 % početne populacije.
English: Do not use Xenical after the expiry date stated on the bottle.
Croatian: Xenical se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci.
English: In the absence of a teratogenic effect in animals, no malformative effect is expected in man. To date, active substances responsible for malformations in man have been found teratogenic in animals when well-conducted studies were performed in two species.
Croatian: Dosad su se djelatne tvari koje uzrokuju malformacije u ljudi, pokazale teratogenima u životinja kada su provedene dobro vođene studije na dvije životinjske vrste.
English: The following table of undesirable effects is based on post-marketing spontaneous reports, and therefore the frequency remains unknown:
Croatian: Sljedeća tablica nuspojava prikazuje spontano prijavljene nuspojave u razdoblju nakon stavljanja lijeka u promet i stoga njihova učestalost nije poznata:
English: Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs e.g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded.
Croatian: U bolesnika istovremeno liječenih orlistatom i antiepilepticima, npr. valproat, lamotrigin, prijavljene su konvulzije za koje se ne može isključiti da su uzrokovane interakcijom tih lijekova.
English: Capsule shell: gelatine indigo carmine (E132) titanium dioxide (E171) edible printing ink (black iron oxide, ammonia solution concentrated, potassium hydroxide, shellac, propylene glycol)
Croatian: Ovojnica kapsule: želatina indigo karmin (E132) titanijev dioksid (E171) jestiva tinta za označavanje (željezov oksid crni, koncentrirana otopina amonijaka, kalijev hidroksid, šelak, propilenglikol)
English: It works in your digestive system to block about one-third of the fat in the food you eat from being digested.
Croatian: Djeluje u probavnom sustavu tako što sprječava probavu oko jedne trećine masnoća iz obroka.
English: What you need to know before you take XENICAL
Croatian: Što morate znati prije nego počnete uzimati XENICAL Nemojte uzimati XENICAL
English: Each capsule contains 120 mg of orlistat.
Croatian: Jedna kapsula sadrži 120 mg orlistata.
English: A decrease in ciclosporin plasma levels has been observed in a drug-drug-interaction study and also reported in several cases, when orlistat was administered concomitantly.
Croatian: Ciklosporin Smanjenje razine ciklosporina u plazmi opaženo je u studiji interakcija s ostalim lijekovima te je prijavljeno u nekoliko slučajeva u kojima se lijek primjenjivao u kombinaciji s orlistatom.
English: In obese type 2 diabetic patients insufficiently controlled by antidiabetic agents, data from four oneyear clinical trials showed that the percentage of responders (≥ 10 % of body weight loss) was 11.3 % with orlistat as compared to 4.5 % with placebo.
Croatian: U pretilih bolesnika s dijabetesom tipa II koji nisu u potpunosti kontrolirani antidijabeticima, podaci iz četiri jednogodišnje studije pokazuju da je postotak onih koji su odgovorili na terapiju (≥ 10 % gubitka tjelesne težine) bio 11,3 % uz primjenu orlistata u usporedbi s 4,5 % uz primjenu placeba.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva bulozne erupcije
English: • If you have any further questions, please ask your doctor or your pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.