FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of severe oesophageal adverse reactions appears to be greater in patients who fail to take alendronate properly and/or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation.
Croatian: Čini se da je rizik od teških nuspojava na jednjaku veći u bolesnica koje se ne pridržavaju uputa o uzimanju alendronata i/ili u bolesnica koje nastave uzimati alendronat nakon pojave simptoma koji upućuju na nadražaj jednjaka.
English: Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking VANTAVO.
Croatian: Mogu se pojaviti nadražaj, upala ili vrijedovi (čirevi) na jednjaku (cijev koja spaja usta sa želucem), često sa simptomima boli u prsištu, žgaravice ili otežanog ili bolnog gutanja, posebno u bolesnica koje VANTAVO tabletu ne popiju s punom čašom vode i/ili u onih koje legnu ne pričekavši da prođe 30 minuta od uzimanja lijeka.
English: In the absence of adequate sunlight exposure, vitamin D3 is an essential dietary nutrient.
Croatian: Kad je izlaganje sunčevoj svjetlosti nedovoljno, neophodan je unos vitamina D3 hranom.
English: There are no or limited amount of data from the use of alendronate in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni alendronata u trudnica ograničeni.
English: The other ingredients are microcrystalline cellulose (E460), lactose anhydrous (see section 2), medium chain triglycerides, gelatin, croscarmellose sodium, sucrose (see section 2), colloidal silicon dioxide, magnesium stearate (E572), butyl hydroxytoluene (E321), modified starch (maize), and sodium aluminium silicate (E554).
Croatian: Drugi sastojci su mikrokristalična celuloza, (E460), bezvodna laktoza (pogledajte dio 2.), trigliceridi srednje duljine lanca, želatina, umrežena karmelozanatrij, saharoza (pogledajte dio 2.), koloidni, bezvodni silicijev dioksid, magnezijev stearat (E572), butilhidroksitoluen (E321), modificirani škrob (kukuruzni) i natrijev aluminijev silikat (E554).
English: Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastrointestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastrointestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty (see section 4.3).
Croatian: Zbog mogućnosti pogoršanja postojeće bolesti, posebna pozornost mora se obratiti kod primjene alendronata u bolesnica s aktivnim tegobama u gornjem dijelu gastrointestinalnog trakta kao što su disfagija, bolest jednjaka, gastritis, upala dvanaesnika, ulkusi ili nedavna anamneza (u posljednjih godinu dana) težih gastrointestinalnih bolesti kao što su peptički ulkus ili aktivno gastrointestinalno krvarenje ili operativni zahvat u gornjem dijelu gastrointestinalnog trakta, osim piloroplastike (vidjeti dio 4.3).
English: • Patients should only swallow VANTAVO whole.
Croatian: • Bolesnice moraju VANTAVO tabletu progutati cijelu.
English: Do not crush or chew the tablet or allow it to dissolve in your mouth because of the possibility of mouth ulceration.
Croatian: Nemojte drobiti ni žvakati tabletu niti dopustiti da se rastopi u ustima jer mogu nastati vrijedovi u ustima.
English: • you have poor dental health, gum disease, a planned dental extraction or you don't receive routine dental care,
Croatian: • imate loše zdravlje zuba, bolest zubnog mesa, ako planirate vađenje zuba ili nemate odgovarajuću stomatološku zaštitu,
English: Additional supplementation with vitamin D should be considered on an individual basis taking into account any vitamin D intake from vitamins and dietary supplements.
Croatian: Potrebno je na individualnoj bazi razmotriti uzimanje dodatne količine vitamina D, a pri tome treba uzeti u obzir količinu vitamina D koju bolesnica unosi pripravcima vitamina ili dodacima prehrani.
English: Take one VANTAVO tablet once a week.
Croatian: Uzmite jednu VANTAVO tabletu jedanput na tjedan.
English: Severe vitamin D deficiency may cause muscle weakness which can lead to falls and a greater risk of fractures.
Croatian: Značajan nedostatak vitamina D može uzrokovati slabost mišića, a time i padove, čime se povećava i rizik od prijeloma kostiju.
English: Alendronate prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone.
Croatian: Alendronat sprečava gubitak koštane mase do kojega dolazi u žena nakon menopauze, pomaže ponovnu izgradnju kosti i smanjuje rizik od prijeloma kralježnice i kuka.
English: Uncommon eye inflammation (uveitis, scleritis, or episcleritis)
Croatian: Poremećaji oka manje često upala oka (uveitis, skleritis ili episkleritis)
English: Stopping smoking Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.
Croatian: Čini se da pušenje ubrzava gubitak koštane mase, stoga može povećati rizik od prijeloma.
English: • unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Croatian: • rijetko može doći do neuobičajenog prijeloma bedrene kosti, osobito u bolesnica koje se dugotrajno liječe zbog osteroporoze.
English: • rash; redness of the skin,
Croatian: • osip, crvenilo kože,
English: Marketing Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Merck Sharp & Dohme B.V.
English: The percentage of patients with vitamin D deficiency was 0.3 % in the Vitamin D3 2,800 group vs. zero in the Vitamin D3 5,600 group.
Croatian: Postotak bolesnica s nedostatkom vitamina D bio je 0,3% u skupini Vitamin D3 2800 u usporedbi s 0% u skupini Vitamin D3 5600.
English: There is important additional information about how to take VANTAVO in the package leaflet.
Croatian: Važne dodatne informacije o tome kako uzimati VANTAVO navedene su u Uputi o lijeku.
English: This adverse reaction was identified through post-marketing surveillance.
Croatian: Ova je nuspojava zabilježena praćenjem nakon stavljanja lijeka u promet.
English: There have been side effects (for example, blurred vision, dizziness and severe bone, muscle or joint pain) reported with VANTAVO that may affect your ability to drive or operate machinery (see section 4).
Croatian: Prijavljene su nuspojave na VANTAVO (npr. zamagljen vid, omaglica i jaki bolovi u kostima, mišićima ili zglobovima) koje mogu utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima (pogledajte dio 4.).
English: Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
Croatian: U bolesnice u koje se posumnja na netipičan prijelom femura treba razmotriti prekid liječenja bisfosfonatima dok se ne ocijeni njezino stanje, na temelju procjene individualne koristi i rizika.
English: • pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Croatian: • bol u ustima i/ili čeljusti, oticanje ili rane u ustima, utrnulost ili osjećaj težine u čeljusti ili pomičnost zuba.
English: The mean increases from baseline in lumbar spine BMD at one year were 5.1 % (95 % CI: 4.8, 5.4 %) in the 70 mg once-weekly group and 5.4 % (95 % CI: 5.0, 5.8 %) in the 10 mg daily group.
Croatian: Prosječan porast BMD-a u lumbalnom dijelu kralježnice s obzirom na početne vrijednosti nakon godine dana ispitivanja iznosio je 5,1% (95% CI: 4,8, 5,4%) u skupini koja je primala tjednu dozu alendronata od 70 mg, odnosno 5,4% (95% CI: 5,0, 5,8%) u skupini koja je primala dnevnu dozu alendronata od 10 mg.
English: Conversion to the active calcium-mobilizing hormone 1,25-dihydroxyvitamin D3 (calcitriol) in the kidney is tightly regulated.
Croatian: Pretvorba u aktivni hormon 1,25-dihidroksivitamin D3 (kalcitriol), koji mobilizira kalcij, odvija se u bubrezima i precizno je regulirana.
English: Alendronate
Croatian: Alendronat
English: BLISTER FOR VANTAVO 70 mg/5,600 IU
Croatian: BLISTER ZA VANTAVO 70 mg/5600 IU
English: • a history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures and poorly fitting dentures
Croatian: • anamneza bolesti zuba, loša oralna higijena, bolesti parodonta, invazivni stomatološki zahvati i neodgovarajuće zubne proteze.
English: Alendronate given during pregnancy in rats caused dystocia related to hypocalcaemia (see section 5.3).
Croatian: U skotnih ženki štakora alendronat je uzrokovao otežan okot povezan s hipokalcijemijom (vidjeti dio 5.3).
English: The frequency of rare was estimated based on relevant clinical trials.
Croatian: Na temelju podataka iz odgovarajućih kliničkih ispitivanja učestalost je procijenjena kao rijetka.
English: In patients with known Barrett's oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.
Croatian: U bolesnica s dijagnozom Barretovog jednjaka, liječnici koji propisuju VANTAVO moraju procijeniti korist liječenja alendronatom u odnosu na moguće rizike u svake pojedine bolesnice.
English: As a result, bone loss occurs and bones become weaker.
Croatian: Posljedica toga je gubitak koštane mase i slabljenje kostiju.
English: Vitamin D3 is rapidly distributed mostly to the liver where it undergoes metabolism to 25-hydroxyvitamin D3, the major storage form.
Croatian: Vitamin D3 brzo se raspodjeljuje, većinom u jetru, gdje se metabolizira do 25-hidroksivitamina D3, oblika u kojemu se najčešće pohranjuje.
English: • hair loss; itching,
Croatian: • gubitak kose, svrbež,
English: Every week, take one VANTAVO tablet on your chosen day.
Croatian: Svakoga tjedna, u odabrani dan, uzmite jednu VANTAVO tabletu.
English: Studies in rats have shown that treatment with alendronate during pregnancy was associated with dystocia in dams during parturition which was related to hypocalcaemia.
Croatian: Istraživanja na štakorima ukazala su na vezu između liječenja alendronatom tijekom skotnosti i otežanog okota ženki povezanog s hipokalcijemijom.
English: Vitamin D3 is converted to 25-hydroxyvitamin D3 in the liver, and stored until needed.
Croatian: Vitamin D3 se u jetri pretvara u 25-hidroksivitamin D3 i pohranjuje dok se ne ukaže potreba za njim.
English: Choose the day of the week that best fits your schedule.
Croatian: Odaberite dan u tjednu koji najviše odgovara Vašim uobičajenim aktivnostima.
English: • VANTAVO should not be taken at bedtime or before arising for the day.
Croatian: • VANTAVO se ne smije uzimati navečer prije spavanja niti ujutro prije ustajanja.
English: Excipients with known effect Each tablet contains 63 mg lactose (as lactose anhydrous) and 16 mg sucrose.
Croatian: Pomoćne tvari s poznatim učinkom Jedna tableta sadrži 63 mg laktoze (u obliku bezvodne laktoze) i 16 mg saharoze.
English: Rare symptomatic hypocalcaemia, often in association with predisposing conditions.
Croatian: Poremećaji metabolizma i prehrane rijetko simptomatska hipokalcijemija, često povezana s predisponirajućim stanjima
English: Medicines for fits (seizures) (like phenytoin or phenobarbital) may decrease the effectiveness of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Croatian: Lijekovi za liječenje napadaja (poput fenitoina ili fenobarbitala) mogu smanjiti učinkovitost vitamina D.
English: Common abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation Uncommon nausea, vomiting, gastritis, oesophagitis*, oesophageal erosions*, melena
Croatian: Poremećaji probavnog sustava često bol u abdomenu, dispepsija, konstipacija, dijareja, flatulencija, ulkus jednjaka*, disfagija*, distenzija abdomena, regurgitacija želučane kiseline manje često mučnina, povraćanje, gastritis, ezofagitis*, ezofagealne erozije*, melena rijetko ezofagealna striktura*, orofaringealni ulkus*, perforacije, ulkusi i krvarenja u gornjem dijelu gastrointestinalnog trakta
English: The earlier a woman reaches the menopause, the greater the risk of osteoporosis.
Croatian: Žene u kojih menopauza nastupi ranije imaju veći rizik od razvoja osteoporoze.
English: If you miss a dose, just take one tablet on the morning after you remember.
Croatian: Ako propustite uzeti dozu, jednostavno uzmite jednu tabletu sljedećeg jutra.
English: The two treatment groups were also similar with regard to BMD increases at other skeletal sites.
Croatian: Dvije ispitivane skupine imale su sličan rast mineralne gustoće kostiju i na drugim dijelovima skeleta.
English: In severe cases, deficiency results in secondary hyperparathyroidism, hypophosphataemia, proximal muscle weakness and osteomalacia, further increasing the risk of falls and fractures in osteoporotic individuals.
Croatian: D dolazi do sekundarnoga hiperparatiroidizma, hipofosfatemije, slabljenja proksimalnih mišića i osteomalacije, čime se još više povećava rizik od padova i prijeloma kostiju u osoba s osteoporozom.
English: Neopharmed Gentili S.p.A. Tel. + 39 02 89 13 21 regulatory@neogen.it
Croatian: + 39 02 89 13 21 regulatory@neogen.it
English: Read the Package Leaflet before use.
Croatian: Prije uporabe pročitajte uputu o lijeku.
English: The bioavailability of the 2800 IU vitamin D3 in VANTAVO is similar to 2800 IU vitamin D3 administered alone.
Croatian: Bioraspoloživost 2800 IU vitamina D3 u lijeku VANTAVO slična je onoj kod primjene 2800 IU samog vitamina D3.
English: Instruction Card
Croatian: Kartica s uputama
English: How to take VANTAVO
Croatian: Kako uzimati VANTAVO
English: The mean BMD increases were 2.3 % and 2.9 % at the femoral neck and 2.9 % and 3.1 % at the total hip in the 70 mg once weekly and 10 mg daily groups, respectively.
Croatian: Prosječan porast BMD-a u skupini koja je primala 70 mg jedanput na tjedan iznosio je 2,3% za vrat bedrene kosti i 2,9% za kuk, a u skupini koja je primala 10 mg jedanput na dan 2,9% za vrat bedrene kosti i 3,1% za kuk.
English: The active substances are alendronic acid and colecalciferol (vitamin D3).
Croatian: Djelatne tvari su alendronatna kiselina i kolekalciferol (vitamin D3).
English: The mean maximal serum concentration (Cmax) of vitamin D3 was 5.9 ng/ml, and the median time to maximal serum concentration (Tmax) was 12 hours.
Croatian: Prosječna najviša koncentracija (Cmax) vitamina D3 u serumu iznosila je 5,9 ng/ml, dok je medijan vremena potrebnog za njezino postizanje (Tmax) bio 12 sati.
English: The mean maximal serum concentration (Cmax) of vitamin D3 was 12.2 ng/ml and the median time to maximal serum concentration (Tmax) was 10.6 hours.
Croatian: Prosječna najviša koncentracija (Cmax) vitamina D3 u serumu iznosila je 12,2 ng/ml, dok je medijan vremena potrebnog za njezino postizanje (Tmax) bio 10,6 sati.
English: 3) Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet.
Croatian: 3) Nakon što progutate tabletu, najmanje 30 minuta nemojte leći - ostanite u potpuno uspravnom položaju (možete sjediti, stajati ili hodati).
English: Patients should be instructed that if they miss a dose of VANTAVO they should take one tablet on the morning after they remember.
Croatian: Bolesnice treba poučiti da, propuste li uzeti VANTAVO tabletu, istu moraju uzeti sljedećeg jutra.
English: In the initial efficacy studies, the mean BMD increases with alendronate 10 mg/day relative to placebo at three years were 8.8 %, 5.9 % and 7.8 % at the spine, femoral neck and trochanter, respectively.
Croatian: U ranim je ispitivanjima djelotvornosti nakon tri godine u skupini koja je primala alendronat u dozi od 10 mg na dan srednji BMD bio veći za 8,8% za kralježnicu, 5,9% za vrat bedrene kosti i 7,8% za trohanter u odnosu na skupinu koja je primala placebo.
English: Return to taking one tablet once a week, as originally scheduled on your chosen day.
Croatian: Nastavite uzimati jednu tabletu jedanput na tjedan, prema uobičajenom rasporedu, na odabrani dan.
English: A subset had recurrence of symptoms when rechallenged with the same medicinal product or another bisphosphonate.
Croatian: U dijela bolesnica je nakon ponovnog uvođenja istog lijeka ili nekog drugog bisfosfonata došlo do ponovne pojave simptoma.
English: The bioavailability of the 5,600 IU vitamin D3 in VANTAVO is similar to 5,600 IU vitamin D3 administered alone.
Croatian: Bioraspoloživost 5600 IU vitamina D3 u lijeku VANTAVO slična je onoj kod primjene 5600 IU samog vitamina D3.
English: 6) After swallowing your VANTAVO tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
Croatian: 6) Nakon što progutate VANTAVO tabletu, najmanje 30 minuta nemojte jesti, piti niti uzimati druge lijekove, uključujući antacide (lijekove za sniženje želučane kiseline), nadomjestke kalcija i vitamine.
English: The alendronate component in the VANTAVO (70 mg/2800 IU) combination tablet and the VANTAVO (70 mg/5,600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Croatian: Alendronat sadržan u kombiniranoj VANTAVO (70 mg/2800 IU) tableti i kombiniranoj VANTAVO (70 mg/5600 IU) tableti bioekvivalentan je alendronatu u tableti od 70 mg.
English: • if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing,
Croatian: • ako imate tegobe s jednjakom (cijev koja spaja usta sa želucem) poput suženja jednjaka ili otežanog gutanja,
English: • bone, muscle and/or joint pain which is sometimes severe.
Croatian: • bolovi u kostima, mišićima i/ili zglobovima, ponekad jaki.
English: In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with VANTAVO.
Croatian: U bolesnica s ovim stanjima se tijekom liječenja lijekom VANTAVO moraju pratiti koncentracija kalcija u serumu i simptomi hipokalcijemije.
English: Take one tablet once a week.
Croatian: Uzmite jednu tabletu jedanput na tjedan.
English: Following absorption, vitamin D3 enters the blood as part of chylomicrons.
Croatian: Vitamin D3 nakon apsorpcije ulazi u krv u sastavu hilomikrona.
English: The following instructions should be followed exactly in order to minimise the risk of oesophageal irritation and related adverse reactions (see section 4.4):
Croatian: Kako bi se smanjio rizik od nadražaja jednjaka i s time povezanih nuspojava, treba se strogo pridržavati sljedećih uputa (vidjeti dio 4.4):
English: Take one tablet once a week
Croatian: Uzmite jednu tabletu jedanput na tjedan
English: Preclinical studies have shown preferential localisation of alendronate to sites of active resorption.
Croatian: Neklinička su ispitivanja pokazala da se alendronat veže ponajprije na mjesta aktivne resorpcije kostiju.
English: Patients in the Vitamin D3 2,800 group received VANTAVO (70 mg/2,800 IU) (n=299) and patients in the Vitamin D3 5,600 group received VANTAVO (70 mg/2,800 IU) plus an additional 2,800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed.
Croatian: Bolesnice u skupini Vitamin D3 2800 uzimale su VANTAVO (70 mg/2800 IU) (n=299) jedanput na tjedan, dok su bolesnice u skupini Vitamin D3 5600 uzimale VANTAVO (70 mg/2800 IU) uz dodatak 2800 IU vitamina D3 (n=309) jedanput na tjedan; bio je dopušten dodatni nadomjestak vitamina D.
English: Excipients with known effect Each tablet contains 62 mg lactose (as lactose anhydrous) and 8 mg sucrose.
Croatian: Pomoćne tvari s poznatim učinkom Jedna tableta sadrži 62 mg laktoze (u obliku bezvodne laktoze) i 8 mg saharoze.
English: • transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment,
Croatian: • prolazni simptomi nalik gripi, kao što su bolovi u mišićima, opće loše stanje, a katkad i vrućica,
English: Patients with malabsorption may not adequately absorb vitamin D3.
Croatian: U bolesnica s malapsorpcijom može doći do smanjenja apsorpcije vitamina D3.
English: EU/1/09/572/004 - 12 tablets
Croatian: EU/1/09/572/004 - 12 tableta
English: Alendronate studies
Croatian: Ispitivanja alendronata
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR VANTAVO 70 mg/2,800 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA VANTAVO 70 mg/2800 IU
English: No additional adverse reactions have been identified for the combination of alendronate and colecalciferol.
Croatian: Osim njih nisu bile prepoznate druge nuspojave vezane za kombinaciju alendronata i kolekalciferola.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR VANTAVO 70 mg/5,600 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA VANTAVO 70 mg/5600 IU
English: • abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,
Croatian: • bol u trbuhu, nelagoda u želucu ili podrigivanje nakon jela, zatvor, osjećaj težine u trbuhu ili nadutost, proljev, vjetrovi,
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with oral bisphosphonates in patients with poor dental status.
Croatian: Prije početka liječenja oralnim bisfosfonatima u bolesnica s lošim dentalnim statusom mora se razmotriti stomatološki pregled uz primjenu odgovarajućih preventivnih stomatoloških mjera.
English: In this study, mean 25-hydroxyvitamin D levels in patients with vitamin D insufficiency at baseline (25-hydroxyvitamin D, 22.5 to 37.5 nmol/l [9 to < 15 ng/ml]) increased from 30 nmol/l (12.1 ng/ml) to 40 nmol/l (15.9 ng/ml) at week 15 in the VANTAVO (70 mg/2800 IU) group (n=75) and decreased from 30 nmol/l (12.0 ng/ml) at baseline to 26 nmol/l (10.4 ng/ml) at week 15 in the alendronate-only group (n=70).
Croatian: U ovom su ispitivanju srednje vrijednosti 25-hidroksivitamina D u bolesnica s početnim nedostatkom vitamina D (25-hidroksivitamin D, 22,5 do 37,5 nmol/l [9 do < 15 ng/ml]) liječenih VANTAVO tabletama (70 mg/2800 IU) (n=75) porasle s početnih 30 nmol/l (12,1 ng/ml) na 40 nmol/l (15,9 ng/ml) u 15. tjednu, dok su u skupini koja je primala samo alendronat one u 15. tjednu pale s početnih 30 nmol/l (12,0 ng/ml) na 26 nmol/l (10,4 ng/ml) (n=70).
English: The following risk factors should be considered when evaluating an individual's risk of developing osteonecrosis of the jaw:
Croatian: Pri procjeni rizika od razvoja osteonekroze čeljusti u svake pojedine bolesnice, u obzir se moraju uzeti sljedeći rizični faktori:
English: The most commonly reported adverse reactions are upper gastrointestinal adverse reactions including abdominal pain, dyspepsia, oesophageal ulcer, dysphagia, abdominal distension and acid regurgitation
Croatian: Najčešće prijavljene nuspojave su nuspojave u gornjem dijelu gastrointestinalnog trakta koje uključuju bol u abdomenu, dispepsiju, ulkus jednjaka, disfagiju, abdominalnu distenziju i regurgitaciju želučane kiseline (> 1%).
English: Very common musculoskeletal (bone, muscle or joint) pain which is sometimes severe Common joint swelling Rare osteonecrosis of the jaw
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često bolovi u mišićno-koštanom sustavu (u kostima, mišićima ili zglobovima), koji su ponekad jaki često oticanje zglobova rijetko osteonekroza čeljusti
English: • narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach),
Croatian: • suženje jednjaka (jednjak je cijev koja spaja usta sa želucem),
English: Musculoskeletal pain
Croatian: Bolovi u mišićno-koštanom sustavu