FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study comparing Evista with oestrogen, bone from patients treated with either medicinal product was histologically normal, with no evidence of mineralisation defects, woven bone or marrow fibrosis.
Croatian: U ispitivanju u kojem se uspoređivala Evista s estrogenom, kosti bolesnica koje su liječene jednim od lijekova bile su histološki uredne, bez dokaza poremećaja mineralizacije, iskrivljenja kostiju ili fibroze srži.
English: Evista contains lactose
Croatian: Evista sadrži laktozu
English: In the osteoporosis treatment study, significantly fewer Evista-treated patients required initiation of hypolipidaemic therapy compared to placebo.
Croatian: U ispitivanju liječenja osteoporoze značajno manji broj bolesnica liječenih Evistom zahtijevao je uvođenje hipolipemičke terapije u usporedbi sa skupinom koja je primala placebo.
English: Evista is only for use in postmenopausal women.
Croatian: Evista je namijenjena samo za primjenu kod žena u postmenopauzi.
English: Three trials included 1,764 postmenopausal women who were treated with Evista and calcium or calcium supplemented placebo.
Croatian: Tri su ispitivanja obuhvatila 1764 žene u postmenopauzi koje su liječene Evistom i kalcijem ili placebom s nadomjestkom kalcija.
English: Likewise, Evista is indicated for the treatment of osteoporosis or established osteoporosis in women with BMD of the spine 2.5 SD below the mean value of a normal young population and/or with vertebral fractures, irrespective of BMD.
Croatian: Također, Evista je indicirana u liječenju osteoporoze ili utvrđene osteoporoze u žena s vrijednošću BMD kralježnice 2,5 SD ispod srednje vrijednosti zdrave mlade populacije i/ili s prijelomima kralježaka neovisno o BMD-u.
English: In postmenopausal women with osteoporosis, Evista reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Croatian: U žena u postmenopauzi koje boluju od osteoporoze Evista smanjuje incidenciju prijeloma kralježaka, čuva koštanu masu i povećava mineralnu gustoću kostiju (BMD, bone mineral density).
English: 84 film coated tablets
Croatian: 84 filmom obloženih tableta
English: Evista produced significant increases in bone density of hip and spine as well as total body mineral mass compared to placebo.
Croatian: Evista je značajno povećala gustoću kosti kuka i kralježnice te cjelokupnu mineralnu masu tijela u usporedbi s placebo skupinom.
English: In patients with moderate and mild renal impairment, Evista should be used with caution.
Croatian: Kod bolesnica sa umjerenim i blagim bubrežnim oštećenjem Evistu treba uzimati s oprezom.
English: The safety of Evista in patients with breast cancer has not been adequately studied.
Croatian: Sigurnost primjene Eviste u bolesnica s karcinomom dojke nije dovoljno ispitivana.
English: What Evista looks like and contents of the pack Evista are white, oval, film coated tablets which are marked with the number 4165.
Croatian: Evista su bijele, ovalne, filmom obložene tablete s otisnutim brojem 4165.
English: The majority of side effects seen with Evista have been mild.
Croatian: Većina nuspojava primijećenih s Evistom su blage.
English: What Evista contains - The active substance is raloxifene hydrochloride.
Croatian: Što Evista sadrži - Djelatna tvar je raloksifenklorid.
English: Evista has no effect on the risk of ER negative breast cancers.
Croatian: Evista nema učinak na rizik od karcinoma dojke negativnog na ER.
English: Raloxifene modestly increases hormone-binding globulin concentrations, including sex steroid binding globulins (SHBG), thyroxine binding globulin (TBG), and corticosteroid binding globulin (CBG), with corresponding increases in total hormone concentrations.
Croatian: Raloksifen umjereno povisuje koncentraciju globulina za koje se vežu hormoni, uključujući globuline za koje se vežu steroidni spolni hormoni (SHBG), globuline za koje se veže tiroksin (TBG) te globuline za koje se vežu kortikosteroidi (CBG), koje prati povišenje ukupnih koncentracija hormona.
English: There was no difference between Evista and placebo treated women in the incidences of vaginal bleeding (spotting) or vaginal discharge.
Croatian: Nije postojala razlika između žena koje su liječene Evistom u usporedbi s placebom u incidenciji vaginalnog krvarenja (probojnog krvarenja) ili vaginalnog iscjetka.
English: In children, symptoms of accidental overdose included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, and elevation in alkaline phosphatase.
Croatian: Simptomi slučajnog predoziranja u djece uključivali su ataksiju, omaglicu, povraćanje, osip, proljev, tremor, crvenilo uz osjećaj vrućine i porast vrijednosti alkalne fosfataze.
English: Evista should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Croatian: Evistu ne smiju uzimati bolesnice s oštećenjem jetre (vidjeti dio 4.3 i 4.4).
English: The frequencies for postmarketing reports were calculated from placebo-controlled clinical trials (comprising a total of 15,234 patients, 7,601 on raloxifene 60 mg and 7,633 on placebo) in postmenopausal women with osteoporosis, or established coronary heart disease (CHD) or increased risk for CHD, without comparison to the frequencies of adverse events in the placebo assignment groups.
Croatian: Učestalosti za postmarketinška izvješća izračunate su iz placebo kontroliranih kliničkih ispitivanja (koja uključuju ukupno 15 234 bolesnice, 7601 koje su uzimale raloksifen od 60 mg i 7633 koje su uzimale placebo) u žena u postmenopauzi s osteoporozom, ili dokazanom koronarnom bolesti srca (KBS), ili povećanim rizikom za KBS-a, bez usporedbe s učestalostima štetnih događaja u skupinama kojima je dodijeljen placebo.
English: 6.3 Shelf-life 3 years.
Croatian: 6.3 Rok valjanosti
English: PHARMACEUTICAL FORM AND CONTENTS 100 film coated tablets
Croatian: OBLIK I SADRŽAJ 100 filmom obloženih tableta
English: Across all placebo-controlled trials, Evista was indistinguishable from placebo with regard to frequency and severity of breast symptoms (no swelling, tenderness and breast pain).
Croatian: U svim placebom kontroliranim ispitivanjima nije se mogla uočiti razlika između Eviste i placeba u učestalosti pojave i težini simptoma dojke (bez edema, osjetljivosti i bolnih dojki).
English: Evista should not be used in children of any age.
Croatian: Evistu ne smiju uzimati djeca bilo koje dobi.
English: Evista contains lactose.
Croatian: Evista sadrži laktozu.
English: • If you are suffering from breast cancer, as there is insufficient experience of Evista use in women with this disease.
Croatian: • Ako imate karcinom dojke, s obzirom na to da ne postoji dovoljno iskustva s primjenom Eviste u žena s tom bolešću.
English: Similarly, in the RUTH study, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, stroke or overall mortality, including overall cardiovascular mortality, compared to placebo (for the increase in risk of fatal stroke see section 4.4).
Croatian: Slično tome u ispitivanju RUTH, raloksifen nije utjecao na incidenciju infarkta miokarda, hospitalizaciju zbog akutnog koronarnog sindroma, moždani udar ili ukupnu smrtnost, uključujući ukupnu srčano-krvožilnu smrtnost, u usporedbi s placebom (za porast rizika od moždanog udara sa smrtnim ishodom vidjeti dio 4.4).
English: • Medicinal product subject to medical prescription
Croatian: • Lijek se izdaje na recept
English: NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi Sankyo Europe GmbH
Croatian: NAZIV nositelja odobrenja za stavljanje lijeka u promet Daiichi Sankyo Europe GmbH
English: Evista lowers total cholesterol and LDL ("bad") cholesterol.
Croatian: Evista snižava razinu ukupnog kolesterola i LDL („lošeg“) kolesterola.
English: When given during the preimplantation period, raloxifene delayed and disrupted embryo implantation resulting in prolonged gestation and reduced litter size but development of offspring to weaning was not affected.
Croatian: Kada se raloksifen daje prije implantacije, implantacija embrija kasni i poremećena je s posljedičnim produženjem gestacije i smanjenjem broja mladunčadi, ali nema utjecaja na njihov razvoj do trenutka samostalnog hranjenja.
English: de la Industria 30, 28108 Alcobendas (Madrid), Spain.
Croatian: Proizvođač Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas (Madrid), Španjolska.
English: In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke, compared to placebo.
Croatian: U ispitivanju žena u postmenopauzi s dokazanom koronarnom bolesti srca ili povećanim rizikom od koronarnih događaja, raloksifen u usporedbi s placebom nije utjecao na incidenciju infarkta miokarda, hospitalizacije zbog akutnog koronarnog sindroma, ukupnu smrtnost uključujući ukupnu srčanokrvožilnu smrtnost ili moždani udar.
English: Do not use after the expiry date which is stated on the pack after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake„Rok valjanosti“ili „EXP“.
English: Evista is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Croatian: Evista je indicirana u liječenju i prevenciji osteoporoze u žena u postmenopauzi.
English: Therefore Evista is not recommended to be used in patients with hepatic insufficiency.
Croatian: Stoga se primjena Eviste ne preporučuje u bolesnika s insuficijencijom jetre.
English: In the 4th year alone, Evista reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88).
Croatian: Samo u četvrtoj godini liječenja Evista je smanjila rizik novonastalog prijeloma kralješka za 39 % (RR 0,61; CI 0,43; 0,88).
English: Flu syndrome was reported by 16.2 % of Evista treated patients and 14.0 % of placebo treated patients.
Croatian: Sindrom nalik gripi prijavljen je u 16,2 % bolesnica koje su liječene Evistom i u 14,0 % bolesnica koje su dobivale placebo.
English: Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in Evista patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3 % Evista and 18.2 % placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6 % for Evista and 7.1 % placebo).
Croatian: Pojava vazodilatacije (navala crvenila uz osjećaj vrućine) umjereno je povećana u bolesnica koje su uzimale Evistu u usporedbi s bolesnicama koje su uzimale placebo (klinička ispitivanja u prevenciji osteoporoze, 2 do 8 godina postmenopauzalno, 24,3 % Evista i 18,2 % placebo; klinička ispitivanja u liječenju osteoporoze, srednja dob 66 godina, 10,6 % za Evistu i 7,1 % placebo).
English: PHARMACEUTICAL FORM AND CONTENTS 14 film coated tablets
Croatian: OBLIK I SADRŽAJ 14 filmom obloženih tableta
English: 28 film coated tablets
Croatian: 28 filmom obloženih tableta
English: Common side effects (affects 1 to 10 users in 100) are:
Croatian: Česte nuspojave (javljaju se u 1 do 10 na 100 korisnika):
English: Τηλ: +30 210 629 4600
Croatian: Φαρμασερβ-Λιλλυ Α.Ε.Β.Ε. Τηλ: +30 210 629 4600
English: Evista is used to treat and prevent osteoporosis in postmenopausal women.
Croatian: Evista se primjenjuje u liječenju i prevenciji osteoporoze u žena u postmenopauzi.
English: Evista does not treat postmenopausal symptoms, such as hot flushes.
Croatian: Evista ne služi za liječenje simptoma postmenopauze, poput navala crvenila uz osjećaj vrućine.
English: In a study of 7,705 postmenopausal women with a mean age of 66 years and with osteoporosis or osteoporosis with an existing fracture, Evista treatment for 3 years reduced the incidence of vertebral fractures by 47 % (RR 0.53, CI 0.35, 0.79; p < 0.001) and 31 % (RR 0.69, CI 0.56, 0.86; p < 0.001) respectively.
Croatian: U ispitivanju provedenom na 7705 žena u postmenopauzi srednje dobi od 66 godina s osteoporozom ili osteoporozom s postojećim prijelomom, 3-godišnje liječenje Evistom smanjilo je incidenciju prijeloma kralježaka za 47 % (RR 0,53; CI 0,35; 0,79; p < 0,001) odnosno za 31 % (RR 0,69; CI 0,56; 0,86; p < 0,001).
English: How to store Evista
Croatian: Kako uzimati Evistu
English: Evista treatment for 4 years reduced the incidence of vertebral fractures by 46 % (RR 0.54, CI 0.38, 0.75) and 32 % (RR 0.68, CI 0.56, 0.83) in patients with osteoporosis or osteoporosis with an existing fracture respectively.
Croatian: Liječenje Evistom tijekom 4 godine smanjilo je incidenciju prijeloma kralježaka za 46 % (RR 0,54; CI 0,38; 0,75), odnosno 32 % (RR 0,68; CI 0,56; 0,83) u bolesnica s osteoporozom, odnosno osteoporozom s postojećim prijelomom.
English: NAME OF THE MEDICINAL PRODUCT Evista 60 mg film coated tablets
Croatian: NAZIV LIJEKA Evista 60 mg filmom obložene tablete
English: Evista reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47
Croatian: U usporedbi s placebom Evista je smanjila incidenciju kliničkih prijeloma kralježaka za 35 % (HR 0,65; CI 0,47; 0,89).
English: Over the 4 years of the osteoporosis treatment trial (involving 7,705 patients), Evista treatment compared to placebo reduced the risk of total breast cancer by 62 % (RR 0.38; CI 0.21, 0.69), the risk of invasive breast cancer by 71 % (RR 0.29, CI 0.13, 0.58) and the risk of invasive oestrogen receptor (ER) positive breast cancer by 79 % (RR 0.21, CI 0.07, 0.50).
Croatian: U ispitivanju liječenja osteoporoze tijekom 4 godine (koje je uključivalo 7705 bolesnica) liječenje Evistom u usporedbi s placebom smanjilo je rizik od ukupnog karcinoma dojke za 62 % (RR 0,38; CI 0,21; 0,69), rizik od invazivnog karcinoma dojke za 71 % (RR 0,29; CI 0,13; 0,58), i rizik od invazivnog karcinoma dojke pozitivnog na estrogenski receptor (ER) za 79 % (RR 0,21; CI 0,07; 0,50).
English: Evista should not be used in patients with severe renal impairment (see section 4.3).
Croatian: Evistu ne smiju uzimati bolesnice s teškim oštećenjem bubrega (vidjeti dio 4.3).
English: Uncommon: Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial vein thrombophlebitis, Arterial thromboembolic reactions a
Croatian: Manje često: venski tromboembolijski događaji, uključujući duboku vensku trombozu, plućnu emboliju, trombozu vene retine, tromboflebitis površinskih vena arterijske tromboembolijske reakcije a
English: However, modest decreases in the prothrombin time have been observed, and if raloxifene is given concurrently with warfarin or other coumarin derivatives, the prothrombin time should be monitored.
Croatian: Međutim, uočena su umjerena smanjenja protrombinskog vremena što iziskuje praćenje tog vremena kod istodobne primjene raloksifena s varfarinom ili derivatima kumarina.
English: PHARMACEUTICAL FORM Film coated tablet.
Croatian: Filmom obložena tableta.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 60 mg raloksifenklorida, što odgovara 56 mg slobodne baze raloksifena.
English: Another adverse reaction observed was leg cramps (5.5 % for Evista, 1.9 % for placebo in the prevention population and 9.2 % for Evista, 6.0 % for placebo in the treatment population).
Croatian: Grčevi u nogama još su jedna uočena nuspojava (5,5 % kod Eviste i 1,9 % kod placeba u skupini koja je uzimala raloksifen za prevenciju te 9,2 % kod Eviste i 6,0 % kod placeba u skupini koja je uzimala raloksifen za liječenje).
English: Evista contains the active substance raloxifene hydrochloride.
Croatian: Evista sadrži djelatnu tvar raloksifenklorid.
English: This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1 % for Evista and 1.9 % for placebo; and in the treatment population occurred at an incidence of 7.1 % for Evista and 6.1 % for placebo.
Croatian: To je bio periferni edem koji se javio s incidencijom od 3,1 % za Evistu i 1,9 % za placebo u skupini koja je uzimala raloksifen za prevenciju; te koji se javio s incidencijom od 7,1 % za Evistu i 6,1 % za placebo u skupini koja je uzimala raloksifen za liječenje.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/073/001 14 film coated tablets EU/1/98/073/002 28 film coated tablets EU/1/98/073/003 84 film coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/073/001 14 filmom obloženih tableta
English: In a 2-year carcinogenicity study in rats, an increase in ovarian tumors of granulosa/theca cell origin was observed in high-dose females (279 mg/kg/day).
Croatian: U 2-godišnjem ispitivanju karcinogenosti u ženke štakora koje su dobivale veliku dozu raloksifena (279 mg/kg/dan) zabilježena je povećana incidencija tumora ovarija porijekla iz granuloznih ili teka stanica.
English: Tablet coating:
Croatian: Tablični sažetak nuspojava
English: Evista 60 mg film coated tablets raloxifene hydrochloride
Croatian: Evista 60 mg filmom obložene tablete raloksifenklorid
English: In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8 % of 2,557 Evista treated patients and 11.1 % of 2,576 placebo treated patients.
Croatian: U skupini od 2557 bolesnica koje su uzimale Evistu u svrhu liječenja osteoporoze, liječenje je prekinuto zbog bilo kojeg štetnog kliničkog događaja u 12,8 %, a u skupini od 2576 bolesnica koje su uzimale placebo u 11,1 % slučajeva.
English: SPECIAL STORAGE CONDITIONS Store in the original package.
Croatian: ROK VALJANOSTI Rok valjanosti {MM/GGGG} POSEBNE MJERE ČUVANJA Čuvati u originalnom pakiranju.
English: In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7 % of 581 Evista treated patients and 11.1 % of 584 placebo-treated patients.
Croatian: U skupini od 581 bolesnice koje su uzimale Evistu u svrhu prevencije, liječenje je prekinuto zbog bilo koje nuspojave u 10,7 %, a u skupini od 584 bolesnica koje su uzimale placebo u 11,1 % slučajeva.
English: A relative risk of 1.60 (CI 0.95, 2.71) was observed in Evista treated patients compared to placebo.
Croatian: Relativni rizik u bolesnica liječenih Evistom bio je 1,60 (CI 0,95 - 2,71), uspoređujući sa skupinom na placebu.
English: Compared to placebo there was no increased use in Evista treated patients.
Croatian: U bolesnica koje su liječene Evistom nije bilo njihove značajno veće primjene u usporedbi s bolesnicama na placebu.
English: Due to the nature of this disease process, Evista is intended for long term use.
Croatian: Evista je namijenjena za dugotrajnu primjenu.
English: Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg raloxifene.
Croatian: Jedna tableta sadrži 60 mg raloksifenklorida što odgovara 56 mg raloksifena.
English: Reproductive system and breast disorders Common: Mild breast symptoms a such as pain, enlargement and tenderness General disorders and administration site conditions Very common: Flu syndrome
Croatian: Poremećaji reproduktivnog sustava i dojki Često:blagi simptomi dojki a kao što su bol, povećanje i osjetljivost
English: Daiichi Sankyo Europe GmbH Тел.
Croatian: Daiichi Sankyo Deutschland GmbH Tel.
English: LIST OF EXCIPIENTS Also includes lactose See leaflet for further information
Croatian: POPIS POMOĆNIH TVARI Također sadrži laktozu.
English: So any vaginal bleeding while you take Evista is unexpected.
Croatian: Stoga se ne očekuje krvarenje iz rodnice dok uzimate Evistu.
English: Evista must not be taken by women of child bearing potential.
Croatian: Evistu ne smiju uzimati žene generativne dobi.
English: BATCH NUMBER Batch {number}
Croatian: 13. BROJ SERIJE Serija {broj}
English: 6.6 Special precautions for disposal No special requirements.
Croatian: 6.6 Posebne mjere opreza za zbrinjavanje
English: Endometrial thickness measurements in Evista treated women were not different from baseline after 4 years of therapy.
Croatian: Nakon 4 godine, u žena koje su liječene Evistom, izmjerena debljina endometrija nije se razlikovala od početnih vrijednosti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/073/004
Croatian: EU/1/98/073/004
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 60 mg raloksifenklorida, što odgovara 56 mg raloksifena.
English: Charles de Giorgio Ltd. Tel: +356 25600 500
Croatian: Tel: +356 25600 500
English: Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate
Croatian: Jezgra tablete: povidon polisorbat 80 laktoza, bezvodna laktoza hidrat krospovidon magnezijev stearat
English: Musculoskeletal and connective tissue disorders Common: Leg cramps
Croatian: Poremećaji kože i potkožnog tkiva Često: osip a
English: Very common: Gastrointestinal symptoms a such as nausea, vomiting, abdominal pain, dyspepsia Skin and subcutaneous tissue disorders
Croatian: Poremećaji probavnog sustava Vrlo često: gastrointestinalni simptomi a kao što su mučnima, povraćanje, bol u abdomenu,
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava Manje često: trombocitopenija a
English: Common: Rash a
Croatian: 4.8 Nuspojave a.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za primjenu kroz usta.
English: Fewer Evista treated women than placebo treated women required surgical intervention for uterine prolapse.
Croatian: Manji broj kirurških zahvata zbog prolapsa maternice zabilježen je u žena liječenih Evistom u usporedbi sa ženama koje su uzimale placebo.
English: The tablets are for oral use.
Croatian: Tablete se uzimaju kroz usta.
English: Nervous system disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: Magyarország Goodwill Pharma Kft. Tel: +36 62 443 571
Croatian: Tel: +36 62 443 571
English: Evista reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
Croatian: U žena s postmenopauzalnom osteoporozom Evista smanjuje rizik od prijeloma kralježaka.
English: • If you get any side effects talk to your doctor or pharmacist.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: If possible, show them the pack.
Croatian: Ukoliko je moguće, pokažite im pakiranje.
English: This usually lasts 4-5 days.
Croatian: Obično traje 4-5 dana.
English: Don't pass it on to others.
Croatian: Nemojte ga davati drugima.
English: Don't take any more tablets.
Croatian: Nemojte više uzeti nijednu tabletu.
English: • Risk management Plan (RMP)
Croatian: • Plan upravljanja rizikom (RMP)
English: * Post hoc analysis
Croatian: * Post hoc analiza
English: • trouble sleeping
Croatian: • probleme sa spavanjem
English: This effect decreases with increasing age from approximately 40 to 60 years.
Croatian: Ovaj učinak se smanjuje s povećanjem dobi od otprilike 40 prema 60 godina starosti.
English: You are responsible to decide if you are able to drive a motor vehicle or perform other tasks that require increased concentration.
Croatian: Vi ste odgovorni za odluku jeste li sposobni upravljati motornim vozilom ili za obavljanje drugih zadataka pri kojima je potrebna pojačana koncentracija.
English: Overall 58 % of these symptomatic patients recovered.
Croatian: Ukupno 58% ovih simptomatskih bolesnika se oporavilo.
English: • avoid milk and milk products (including ice cream)
Croatian: • izbjegavajte mlijeko i mliječne proizvode (uključujući i sladoled)
English: HER2 status should be determined using accurate and validated methods.
Croatian: HER2 status treba utvrditi primjenom točnih i validiranih metoda.
English: 1, months
Croatian: 1, mjeseci
English: These medicines include some medicines in the following groups:
Croatian: Ovi lijekovi uključuju određene lijekove iz sljedećih skupina:
English: NE=median was not reached.
Croatian: NE=medijan nije dosegnut.
English: These effects are described in section 4, ‘Possible side effects'.
Croatian: Ovi učinci opisani su u dijelu 4. „Moguće nuspojave“.