FrancophonIA/ELRC3.0 huggingface dataset:
English: Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone.
Croatian: Do prijeloma može doći pri obavljanju uobičajenih, svakodnevnih aktivnosti, kao što je podizanje nekog tereta ili uslijed manjih ozljeda koje obično ne bi završile prijelomom zdrave kosti.
English: Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Croatian: Zbog rizika od nadražaja jednjaka ne smije se izazivati povraćanje i bolesnica mora ostati u uspravnom položaju.
English: In this study alendronate daily reduced the incidence of  1 new vertebral fracture by 47 % (alendronate 7.9 % vs. placebo 15.0 %).
Croatian: U tom je ispitivanju dnevna doza alendronata smanjila incidenciju ≥ 1 novog prijeloma kralježaka za 47% (alendronat 7,9% naspram placebo 15,0%).
English: Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur especially in patients taking glucocorticoids in whom calcium absorption may be decreased.
Croatian: Zbog pozitivnog učinka alendronata na porast minerala u kostima može doći do sniženja koncentracije kalcija i fosfata u serumu, osobito u bolesnica koje uzimaju glukokortikoide pa mogu imati smanjenu apsorpciju kalcija.
English: Bioavailability was decreased similarly to an estimated 0.46 % and 0.39 % when alendronate was administered one hour or half an hour before a standardised breakfast.
Croatian: Bioraspoloživost se na sličan način smanjivala na približno 0,46% kada se alendronat uzimao jedan sat, odnosno na 0,39% kada se uzimao pola sata prije standardiziranog doručka.
English: It is unknown whether alendronate/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se alendronat/metaboliti u majčino mlijeko.
English: Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Croatian: Bolesnice s rijetkim nasljednim poremećajima nepodnošenja fruktoze, nepodnošenja galaktoze, nedostatkom Lapp laktaze, malapsorpcijom glukoze i galaktoze ili insuficijencijom saharaza-izomaltaza ne smiju uzimati ovaj lijek.
English: You should not take VANTAVO if you are or think you may be pregnant, or if you are breast-feeding.
Croatian: • žgaravica; otežano gutanje; bolno gutanje; vrijedovi (čirevi) na jednjaku (cijevi koja spaja usta sa želucem) koji mogu uzrokovati bol u prsištu, žgaravicu ili otežano ili bolno gutanje.
English: Osteoporosis is defined as bone mineral density (BMD) of the spine or hip 2.5 standard deviations (SD) below the mean value of a normal young population or as a previous fragility fracture, irrespective of BMD.
Croatian: Osteoporoza se definira kao mineralna gustoća kostiju (engl. bone mineral density, BMD) kralježnice ili kuka koja je za 2,5 standardne devijacije manja od srednje vrijednosti u zdrave mlade populacije, ili kao prethodni prijelom zbog krhkosti kosti, bez obzira na mineralnu gustoću kostiju.
English: • blurred vision; pain or redness in the eye,
Croatian: • zamagljen vid, bol ili crvenilo očiju,
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Croatian: U bolesnica u kojih se u vrijeme liječenja bisfosfonatima razvije osteonekroza čeljusti, dentalni kirurški zahvati mogu pogoršati stanje.
English: When you get out of bed on the day you have chosen, and before taking your first food, drink or other medicines, swallow (do not crush or chew the tablet or allow it to dissolve in your mouth) one VANTAVO tablet with a full glass of water (not mineral water).
Croatian: Toga dana neposredno nakon ustajanja, a prije uzimanja bilo kakve hrane, napitka ili drugog lijeka progutajte jednu VANTAVO tabletu (tabletu nemojte drobiti, žvakati niti dopustiti da se otopi u ustima) s punom čašom obične vode (ne mineralne vode).
English: However, there is a theoretical risk of foetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.
Croatian: Međutim, postoji teoretski rizik od oštećenja fetusa, pretežno oštećenja kostura, u žena koje zatrudne nakon liječenja bisfosfonatima.
English: In healthy subjects, oral prednisone (20 mg three times daily for five days) did not produce a clinically meaningful change in oral bioavailability of alendronate (a mean increase ranging from 20 % to 44 %).
Croatian: U zdravih osoba peroralno primijenjeni prednizolon (20 mg tri puta na dan tijekom pet dana) nije uzrokovao klinički značajne promjene bioraspoloživosti alendronata nakon peroralne primjene (prosječni porast u rasponu od 20% do 44%).
English: ; atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
Croatian: ; netipični subtrohanterični prijelomi i prijelomi dijafize femura (nuspojava skupine bisfosfonata)
English: No evidence of saturation of bone uptake was found after chronic dosing with cumulative intravenous doses up to 35 mg/kg in animals.
Croatian: U životinja nije utvrđeno da dolazi do zasićenja pohrane u kosti nakon dugotrajne primjene kumulativnih intravenskih doza do 35 mg/kg.
English: Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture.
Croatian: Prijelomi su često bilateralni, stoga se mora napraviti pregled kontralateralnog femura u bolesnica liječenih bisfosfonatima koje imaju prijelom dijafize femura.
English: These side effects may worsen if patients continue to take VANTAVO after developing these symptoms.
Croatian: Spomenute se nuspojave mogu pogoršati nastave li bolesnice uzimati VANTAVO i nakon pojave opisanih simptoma.
English: Due to the nature of the disease process in osteoporosis, VANTAVO is intended for long-term use.
Croatian: Zbog prirode bolesti, tj. razvoja osteoporoze, VANTAVO je lijek za dugotrajnu primjenu.
English: The following adverse reactions have been reported during clinical studies and/or post-marketing use with alendronate.
Croatian: Niže navedene nuspojave prijavljene su u kliničkim ispitivanjima i/ili nakon stavljanja alendronata u promet.
English: VANTAVO is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Croatian: VANTAVO je indiciran za liječenje osteoporoze u žena u postmenopauzi s rizikom od nedostatka vitamina D.
English: Do not take VANTAVO
Croatian: Nemojte uzimati VANTAVO
English: Alendronate sodium has been studied in a small number of patients with osteogenesis imperfecta under the age of 18 years.
Croatian: Pedijatrijska populacija Natrijev alendronat je ispitivan u malobrojnih bolesnika mlađih od 18 godina s osteogenesis imperfecta.
English: • black or tar-like stools,
Croatian: • crna stolica ili stolica poput katrana,
English: However, there have been rare reports of symptomatic hypocalcaemia, which have occasionally been severe and often occurred in patients with predisposing conditions (e.g. hypoparathyroidism, vitamin D deficiency and calcium malabsorption) (see section 4.8).
Croatian: Ipak, prijavljeni su i rijetki slučajevi simptomatske hipokalcijemije, od kojih su neki bili teški i obično su se javljali u bolesnica s predisponirajućim stanjima (npr. hipoparatiroidizam, nedostatak vitamina D i malapsorpcija kalcija) (vidjeti dio 4.8).
English: The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans.
Croatian: Prosječan volumen raspodjele u stanju dinamičke ravnoteže, ne uključujući kosti, u ljudi iznosi najmanje 28 litara.
English: Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive problems.
Croatian: Neki lijekovi za ublažavanje reumatizma ili dugotrajnih bolova koji se zovu nesteroidni protuupalni lijekovi (primjerice acetilsalicilatna kiselina ili ibuprofen) mogu izazvati probavne tegobe.
English: Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Croatian: Klinička odluka liječnika koji provodi liječenje mora biti temelj plana liječenja prilagođenog svakoj pojedinoj bolesnici na temelju procjene individualne koristi i rizika.
English: Following a single 10 mg intravenous dose, the renal clearance of alendronate was 71 ml/min, and systemic clearance did not exceed 200 ml/min.
Croatian: Nakon primjene jedne intravenske doze od 10 mg bubrežni klirens alendronata iznosio je 71 ml/min, a sistemski klirens nije prelazio 200 ml/min.
English: Therefore, caution should be used when these medicines are taken at the same time as VANTAVO.
Croatian: Stoga je potreban oprez kada se ti lijekovi uzimaju istodobno s lijekom VANTAVO.
English: 2031 BN, Haarlem, Netherlands
Croatian: 2031 BN, Haarlem, Nizozemska
English: • if you are allergic to alendronic acid, colecalciferol or any of the other ingredients of this medicine (listed in section 6),
Croatian: • ako ste alergični na alendronatnu kiselinu, kolekalciferol ili neki drugi sastojak ovog lijeka
English: The percentage of patients with hypercalciuria at the end of the 24-week extension was not statistically different between treatment groups.
Croatian: Do kraja 24-tjednog nastavka ispitivanja, postotak bolesnica s hiperkalciurijom nije se statistički značajno razlikovao između liječenih skupina.
English: It reduces the risk of spine and hip fractures in women after menopause.
Croatian: On smanjuje rizik od prijeloma kralježnice i kuka u žena nakon menopauze.
English: Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.
Croatian: Bolesnice se mora upozoriti da nepridržavanje uputa može povećati rizik od tegoba s jednjakom.
English: Rare hypersensitivity reactions including urticaria and angioedema
Croatian: Poremećaji imunološkog sustava rijetko reakcije preosjetljivosti uključujući urtikariju i angioedem
English: 1) Choose the day of the week that best fits your schedule.
Croatian: 1) Odaberite dan u tjednu koji najviše odgovara Vašim uobičajenim aktivnostima.
English: Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain or new or worsening heartburn (see section 4.8).
Croatian: Liječnici stoga moraju biti oprezni zbog pojave znakova ili simptoma koji bi upućivali na moguće nuspojave na jednjaku, a bolesnice se moraju uputiti da prestanu uzimati alendronat i zatraže liječničku pomoć pojave li se simptomi nadražaja jednjaka kao što su disfagija, bol pri gutanju ili retrosternalni bolovi, novonastala žgaravica ili pogoršanje žgaravice (vidjeti dio 4.8).
English: Studies in rats show that alendronate transiently distributes to soft tissues following 1 mg/kg intravenous administration but is then rapidly redistributed to bone or excreted in the urine.
Croatian: Istraživanja na štakorima pokazala su da se alendronat nakon intravenske primjene u dozi od 1 mg/kg privremeno raspodjeljuje u meka tkiva, a onda naglo preraspodjeljuje u kost ili eliminira mokraćom.
English: VANTAVO is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see section 4.2).
Croatian: VANTAVO se ne preporučuje bolesnicama s oštećenjem funkcije bubrega u kojih je klirens kreatinina manji od 35 ml/min (vidjeti dio 4.2).
English: If you stop taking VANTAVO
Croatian: Ako prestanete uzimati VANTAVO
English: The principal action of 1,25-dihydroxyvitamin D3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.
Croatian: Osnovni način na koji djeluje 1,25-dihidroksivitamin D3 jest povećavanje apsorpcije kalcija i fosfata iz crijeva, reguliranje koncentracije kalcija u serumu, izlučivanje kalcija i fosfata bubrezima, formiranje i resorpcija kostiju.
English: In this study, a significant difference was observed in the analysis of the subgroup of osteoporotic women (37 % of the global population who correspond with the above definition of osteoporosis) in the incidence of hip fractures (alendronate 1.0 % vs. placebo 2.2 %, a reduction of 56 %) and in the incidence of  1 vertebral fracture (2.9 % vs. 5.8 %, a reduction of 50 %).
Croatian: U ovom je ispitivanju zabilježena značajna razlika u podskupini žena s osteoporozom (37% globalne populacije prema prethodno navedenoj definiciji osteoporoze) u incidenciji prijeloma kuka (alendronat 1,0% naspram placebo 2,2%, smanjenje od 56%) te u incidenciji ≥ 1 prijeloma kralježaka (2,9% naspram 5,8%, smanjenje od 50%).
English: Lesser amounts are distributed to adipose and muscle tissue and stored as vitamin D3 at these sites for later release into the circulation.
Croatian: Manje se količine raspodjeljuju u masno i mišićno tkivo i na tim mjestima pohranjuju kao vitamin D3, koji se odatle kasnije otpušta u krvotok.
English: Bioavailability was negligible whether alendronate was administered with, or up to two hours after, a standardised breakfast.
Croatian: Bioraspoloživost je bila zanemariva kad se alendronat uzimao sa standardiziranim doručkom ili do dva sata nakon njega.
English: VANTAVO is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3.
Croatian: VANTAVO je tableta koja sadrži dvije djelatne tvari, alendronatnu kiselinu (koja se često naziva alendronat) i kolekalciferol, poznat kao vitamin D3.
English: A small percentage of vitamin D3 undergoes glucuronidation prior to elimination.
Croatian: Manji udio vitamina D3 prije eliminacije podliježe glukuronidaciji.
English: • your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus),
Croatian: • Vam je liječnik rekao da imate Barretov jednjak (stanje koje nastaje zbog promjena na stanicama donjeg dijela jednjaka),
English: In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18 % and 10 %, respectively, of patients taking alendronate 10 mg/day versus approximately 12 % and 3 % of those taking placebo.
Croatian: U kliničkim je ispitivanjima uočeno asimptomatsko, blago i prolazno sniženje serumskog kalcija u približno 18% i fosfata u približno 10% bolesnica koje su uzimale alendronat u dozi od 10 mg na dan, naspram 12%, odnosno 3% u bolesnica koje su primale placebo.
English: The mean half-life of vitamin D3 in the serum following an oral dose of VANTAVO (70 mg/2800 IU) is approximately 24 hours.
Croatian: Prosječan poluvijek vitamina D3 u serumu nakon peroralne primjene lijeka VANTAVO (70 mg/2800 IU) iznosi približno 24 sata.
English: While no increased risk was observed in extensive clinical trials with alendronate, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some of which were severe and with complications (see section 4.8).
Croatian: Iako u opsežnim kliničkim ispitivanjima s alendronatom nije zabilježen povećan rizik bilo je rijetkih izvješća (nakon stavljanja lijeka u promet) o pojavi ulkusa želuca i dvanaesnika od kojih su neki bili teški i s komplikacijama (vidjeti dio 4.8).
English: †, peripheral oedema Uncommon transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment
Croatian: †, periferni edem manje često prolazni simptomi kao što su odgovor akutne faze (mialgija, malaksalost i rijetko vrućica), tipično povezani s početkom liječenja
English: 2) After getting up for the day and before taking any food, drink, or other medicine, swallow your
Croatian: 2) Ujutro, nakon ustajanja i prije prvog dnevnog obroka, napitka ili drugog lijeka progutajte cijelu
English: Hypocalcaemia must be corrected before initiating therapy with VANTAVO (see section 4.3).
Croatian: Prije početka liječenja lijekom VANTAVO mora se korigirati hipokalcijemija (vidjeti dio 4.3).
English: During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Croatian: Tijekom liječenja bisfosfonatima bolesnicama treba savjetovati da prijave svaku bol u natkoljenici, kuku ili preponama, a u svake bolesnice s takvim simptomima treba ispitati da li je došlo do nepotpunog prijeloma femura.
English: • FIT 1: A three-year study of 2,027 patients who had at least one baseline vertebral (compression) fracture.
Croatian: • FIT 1: trogodišnje ispitivanje koje je uključilo 2027 bolesnica koje su pri uključivanju u ispitivanje imale najmanje jedan prethodni prijelom kralješka (kompresivni).
English: Vitamin D3 is produced in the skin by conversion of 7-dehydrocholesterol to vitamin D3 by ultraviolet light.
Croatian: Vitamin D3 stvara se u koži pretvorbom 7-dehidrokolesterola u vitamin D3 nakon izlaganja ultraljubičastoj svjetlosti.
English: During bisphosphonate treatment, all patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain, or swelling.
Croatian: Tijekom liječenja bisfosfonatima, sve se bolesnice mora poticati da održavaju dobru oralnu higijenu, redovito posjećuju stomatologa i prijave bilo koji oralni simptom kao što je pomičnost zuba, bol ili oticanje.
English: VANTAVO contains lactose and sucrose.
Croatian: VANTAVO sadrži laktozu i saharozu.
English: Alendronate can cause local irritation of the upper gastrointestinal mucosa.
Croatian: Alendronat može nadražiti sluznicu gornjeg dijela gastrointestinalnog trakta.
English: You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.
Croatian: Tijekom liječenja morate redovito posjećivati stomatologa i morate obavijestiti svog liječnika ili stomatologa primijetite li bilo kakve tegobe s ustima ili zubima kao što su pomičnost zuba, bol ili oticanje.
English: Concentrations of alendronate in plasma following therapeutic oral doses are too low for analytical detection (< 5 ng/ml).
Croatian: Koncentracija alendronata u plazmi nakon peroralne primjene terapijskih doza (< 5 ng/ml) preniska je za analitičko dokazivanje.
English: Consult your doctor before you begin any exercise programme.
Croatian: Posavjetujte se sa svojim liječnikom prije nego počnete s tjelovježbom.
English: Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
Croatian: Bolesnice ne smiju drobiti niti žvakati tablete, niti dopustiti da se tableta rastopi u ustima zbog mogućnosti razvoja ulceracija orofarinksa.
English: Colecalciferol
Croatian: Kolekalciferol
English: As well as your treatment with VANTAVO, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Croatian: Uz to što Vam je propisao VANTAVO, liječnik Vam može predložiti promjene nekih životnih navika koje mogu poboljšati
English: The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied.
Croatian: Nije ispitan učinak varijabli kao što su vrijeme od prestanka liječenja do začeća, vrsta primijenjenog bisfosfonata i put primjene (intravenska naspram peroralna primjena) na razvoj rizika.
English: Vitamin D3 is rapidly metabolized by hydroxylation in the liver to 25-hydroxyvitamin D3, and subsequently metabolized in the kidney to 1,25-dihydroxyvitamin D3, which represents the biologically active form.
Croatian: Vitamin D3 se u jetri brzo metabolizira hidroksilacijom u 25-hidroksivitamin D3, a nakon toga se u bubrezima metabolizira u 1,25-dihidroksivitamin D3, koji je biološki aktivan oblik.
English: - Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.
Croatian: - Abnormalnosti jednjaka i drugi faktori koji usporavaju njegovo pražnjenje kao što su strikture ili ahalazija.
English: Non-clinical studies with the combination of alendronate and colecalciferol have not been conducted.
Croatian: Nisu provedena neklinička ispitivanja kombinacije alendronata i kolekalciferola.
English: If you forget to take VANTAVO
Croatian: Ako ste zaboravili uzeti VANTAVO
English: This medicinal product contains lactose and sucrose.
Croatian: Ovaj lijek sadrži laktozu i saharozu.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of VANTAVO on an individual patient basis, particularly after 5 or more years of use.
Croatian: Na temelju koristi i mogućih rizika primjene lijeka VANTAVO, potrebu za nastavkom liječenja u svake pojedine bolesnice treba periodički ponovno procijeniti, posebice nakon 5 ili više godina liječenja.
English: It is likely that food and beverages (including mineral water) will make VANTAVO less effective if taken at the same time.
Croatian: Moguće je da će hrana i piće (uključujući mineralnu vodu) smanjiti djelotvornost lijeka VANTAVO ako se uzmu u isto vrijeme kad i lijek.
English: - It is particularly important to understand the information in section 3 before taking this medicine.
Croatian: Pogledajte dio 4. - Prije nego počnete uzimati ovaj lijek, posebno je važno da razumijete upute u dijelu 3.
English: Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
Croatian: Osteonekroza čeljusti prijavljena je i u bolesnica s osteoporozom koje su uzimale oralne bisfosfonate.
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Croatian: Osteonekroza vanjskog slušnog kanala prijavljena je s bisfosfonatima, uglavnom povezana s dugotrajnom terapijom.
English: The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms such as pain or discharge, or chronic ear infections.
Croatian: Mogućnost osteonekroze vanjskog slušnog kanala potrebno je razmotriti u bolesnika koji primaju bisfosfonate, a koji imaju simptome koji zahvaćaju uho uključujući bol ili iscjedak ili kronične infekcije uha.
English: It reduces the risk of spine and hip fractures.
Croatian: Smanjuje rizik od prijeloma kralježnice i kuka.
English: Also contains: lactose and sucrose.
Croatian: Također sadrži: laktozu i saharozu.
English: Patients may experience certain adverse reactions (for example, blurred vision, dizziness and severe bone muscle or joint pain (see section 4.8)) that may influence the ability to drive and use machines.
Croatian: Bolesnice mogu razviti određene nuspojave (npr. zamagljen vid, omaglicu i jake bolove u kostima, mišićima ili zglobovima (vidjeti dio 4.8)) koje mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Preclinical studies show that alendronate that is not deposited in bone is rapidly excreted in the urine.
Croatian: Neklinička su ispitivanja pokazala da se alendronat koji se nije odložio u kosti brzo eliminira mokraćom.
English: Vitamin D insufficiency develops when both sunlight exposure and dietary intake are inadequate.
Croatian: D javlja se kada su i izlaganje sunčevoj svjetlosti i njegov unos hranom nedovoljni.