FrancophonIA/ELRC3.0 huggingface dataset:
English: FOSAVANCE must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day.
Croatian: FOSAVANCE se mora uzimati samo s vodom (ne mineralnom vodom) najmanje 30 minuta prije uzimanja prvoga dnevnog obroka, napitka ili drugih lijekova (uključujući antacide, nadomjestke kalcija i vitamine).
English: What is FOSAVANCE used for?
Croatian: Za što se koristi FOSAVANCE?
English: Results are insufficient to support the use of alendronate sodium in paediatric patients with osteogenesis imperfecta.
Croatian: Rezultati nisu dostatni da opravdaju primjenu natrijevog alendronata u pedijatrijskih bolesnika s osteogenesis imperfecta.
English: You may be advised to have a dental check-up before starting treatment with FOSAVANCE.
Croatian: Liječnik će Vam možda savjetovati da obavite kontrolu kod stomatologa prije nego počnete uzimati FOSAVANCE.
English: Alendronate sodium has been studied in a small number of patients with osteogenesis imperfecta under the age of 18 years.
Croatian: Natrijev alendronat je ispitivan u malobrojnih bolesnika mlađih od 18 godina s osteogenesis imperfecta.
English: It is very important to follow instructions 2), 3), 4) and 5) to help the FOSAVANCE tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
Croatian: Vrlo je važno pridržavati se uputa navedenih pod 2), 3), 4) i 5) kako bi FOSAVANCE tableta brzo stigla do želuca i kako bi se smanjila vjerojatnost da će nadražiti jednjak (jednjak je cijev koja spaja usta sa želucem).
English: The content of vitamin D in FOSAVANCE is not suitable for correction of vitamin D deficiency.
Croatian: Količina vitamina D u lijeku FOSAVANCE nije primjerena za korekciju nedostatka vitamina D.
English: FOSAVANCE should not be used during pregnancy.
Croatian: FOSAVANCE se ne smije primjenjivati tijekom trudnoće.
English: FOSAVANCE tablet whole with a full glass of water only (not mineral water) (not less than
Croatian: FOSAVANCE tabletu s punom čašom obične vode (ne mineralne vode) (najmanje 200 ml)
English: In case of overdose with FOSAVANCE, milk or antacids should be given to bind alendronate.
Croatian: Dođe li do predoziranja FOSAVANCE tabletama, bolesnici se moraju dati mlijeko ili antacidi kako bi vezali alendronat.
English: If you stop taking FOSAVANCE
Croatian: Ako prestanete uzimati FOSAVANCE
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 FOSAVANCE 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 FOSAVANCE tabletu (tabletu nemojte drobiti, žvakati niti dopustiti da se otopi u ustima) s punom čašom obične vode (ne mineralne vode).
English: FOSAVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see section 4.2).
Croatian: FOSAVANCE se ne preporučuje bolesnicama s oštećenjem funkcije bubrega u kojih je klirens kreatinina manji od 35 ml/min (vidjeti dio 4.2).
English: What FOSAVANCE contains
Croatian: Što FOSAVANCE sadrži
English: These side effects may worsen if patients continue to take FOSAVANCE after developing these symptoms.
Croatian: Spomenute se nuspojave mogu pogoršati nastave li bolesnice uzimati FOSAVANCE i nakon pojave opisanih simptoma.
English: FOSAVANCE is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3.
Croatian: FOSAVANCE je tableta koja sadrži dvije djelatne tvari, alendronatnu kiselinu (koja se često naziva alendronat) i kolekalciferol, poznat kao vitamin D3.
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: FOSAVANCE contains lactose and sucrose.
Croatian: FOSAVANCE sadrži laktozu i saharozu.
English: Hypocalcaemia must be corrected before initiating therapy with FOSAVANCE (see section 4.3).
Croatian: Prije početka liječenja lijekom FOSAVANCE mora se korigirati hipokalcijemija (vidjeti dio 4.3).
English: FOSAVANCE is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Croatian: FOSAVANCE je indiciran za liječenje osteoporoze u žena u postmenopauzi s rizikom od nedostatka vitamina D.
English: Take one FOSAVANCE tablet once a week.
Croatian: Uzmite jednu FOSAVANCE tabletu jedanput na tjedan.
English: • Patients should only swallow FOSAVANCE whole.
Croatian: • Bolesnice moraju FOSAVANCE tabletu progutati cijelu.
English: Due to the nature of the disease process in osteoporosis, FOSAVANCE is intended for long-term use.
Croatian: Zbog prirode bolesti, tj. razvoja osteoporoze, FOSAVANCE je lijek za dugotrajnu primjenu.
English: You should not take FOSAVANCE 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: As well as your treatment with FOSAVANCE, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Croatian: Uz to što Vam je propisao FOSAVANCE, liječnik Vam može predložiti promjene nekih životnih navika koje mogu poboljšati
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 FOSAVANCE.
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 FOSAVANCE tabletu ne popiju s punom čašom vode i/ili u onih koje legnu ne pričekavši da prođe 30 minuta od uzimanja lijeka.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of FOSAVANCE on an individual patient basis, particularly after 5 or more years of use.
Croatian: Na temelju koristi i mogućih rizika primjene lijeka FOSAVANCE, potrebu za nastavkom liječenja u svake pojedine bolesnice treba periodički ponovno procijeniti, posebice nakon 5 ili više godina liječenja.
English: The mean half-life of vitamin D3 in the serum following an oral dose of FOSAVANCE (70 mg/2,800 IU) is approximately 24 hours.
Croatian: Prosječan poluvijek vitamina D3 u serumu nakon peroralne primjene lijeka FOSAVANCE (70 mg/2800 IU) iznosi približno 24 sata.
English: How to take FOSAVANCE tablets
Croatian: Kako uzimati FOSAVANCE tablete
English: It is likely that food and beverages (including mineral water) will make FOSAVANCE less effective if taken at the same time.
Croatian: Moguće je da će hrana i piće (uključujući mineralnu vodu) smanjiti djelotvornost lijeka FOSAVANCE ako se uzmu u isto vrijeme kad i lijek.
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), butylhydroxytoluene (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 silicijev dioksid, magnezijev stearat (E572), butilhidroksitoluen (E321), modificirani škrob (kukuruzni) i natrijev aluminijev silikat (E554).
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,
English: If you forget to take FOSAVANCE
Croatian: Ako ste zaboravili uzeti FOSAVANCE
English: There have been side effects (for example, blurred vision, dizziness and severe bone, muscle or joint pain) reported with FOSAVANCE that may affect your ability to drive or operate machinery (see section 4).
Croatian: Prijavljene su nuspojave na FOSAVANCE (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: 2031 BN, Haarlem The Netherlands
Croatian: 2031 BN, Haarlem Nizozemska
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 FOSAVANCE moraju procijeniti korist liječenja alendronatom u odnosu na moguće rizike u svake pojedine bolesnice.
English: • FOSAVANCE should not be taken at bedtime or before arising for the day.
Croatian: • FOSAVANCE se ne smije uzimati navečer prije spavanja niti ujutro prije ustajanja.
English: Every week, take one FOSAVANCE tablet on your chosen day.
Croatian: Svakoga tjedna, u odabrani dan, uzmite jednu FOSAVANCE tabletu.
English: In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with FOSAVANCE.
Croatian: U bolesnica s ovim stanjima se tijekom liječenja lijekom FOSAVANCE moraju pratiti koncentracija kalcija u serumu i simptomi hipokalcijemije.
English: 6) After swallowing your FOSAVANCE 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 FOSAVANCE tabletu, najmanje 30 minuta nemojte jesti, piti niti uzimati druge lijekove, uključujući antacide (lijekove za sniženje želučane kiseline), nadomjestke kalcija i vitamine.
English: Patients should be instructed that if they miss a dose of FOSAVANCE they should take one tablet on the morning after they remember.
Croatian: Bolesnice treba poučiti da, propuste li uzeti FOSAVANCE tabletu, istu moraju uzeti sljedećeg jutra.
English: The bioavailability of the 5,600 IU vitamin D3 in FOSAVANCE is similar to 5,600 IU vitamin D3 administered alone.
Croatian: Bioraspoloživost 5600 IU vitamina D3 u lijeku FOSAVANCE slična je onoj kod primjene 5600 IU samog vitamina D3.
English: FOSAVANCE 70 mg/2,800 IU tablets EU/1/05/310/001 - 2 tablets
Croatian: FOSAVANCE 70 mg/2800 IU tablete EU/1/05/310/001 - 2 tablete
English: Patients in the Vitamin D3 2,800 group received FOSAVANCE (70 mg/2,800 IU) (n=299) and patients in the Vitamin D3 5,600 group received FOSAVANCE (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 FOSAVANCE (70 mg/2800 IU) (n=299) jedanput na tjedan, dok su bolesnice u skupini Vitamin D3 5600 uzimale FOSAVANCE (70 mg/2800 IU) uz dodatak 2800 IU vitamina D3 (n=309) jedanput na tjedan; bio je dopušten dodatni nadomjestak vitamina D.
English: Do not take FOSAVANCE
Croatian: Nemojte uzimati FOSAVANCE
English: BLISTER FOR FOSAVANCE 70 mg/5,600 IU
Croatian: BLISTER ZA FOSAVANCE 70 mg/5600 IU
English: There is important additional information about how to take FOSAVANCE in the package leaflet.
Croatian: Važne dodatne informacije o tome kako uzimati FOSAVANCE navedene su u Uputi o lijeku.
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 FOSAVANCE (70 mg/2,800 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 FOSAVANCE 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: It is important to maintain good oral hygiene when being treated with FOSAVANCE.
Croatian: Tijekom liječenja lijekom FOSAVANCE važno je održavati dobru higijenu usne šupljine.
English: EU/1/05/310/001 (2 tablets) EU/1/05/310/002 (4 tablets) EU/1/05/310/003 (6 tablets) EU/1/05/310/004 (12 tablets)
Croatian: EU/1/05/310/001 (2 tablete) EU/1/05/310/002 (4 tablete) EU/1/05/310/003 (6 tableta) EU/1/05/310/004 (12 tableta)
English: †, pruritus Uncommon rash, erythema Rare rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
Croatian: Poremećaji kože i potkožnog tkiva često alopecija †, pruritus manje često osip, eritem rijetko osip s reakcijama preosjetljivosti na svjetlost, teške kožne reakcije uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu
English: It is likely that certain medicines or food additives may prevent the vitamin D in FOSAVANCE from getting into your body, including artificial fat substitutes, mineral oils, the weight loss medicine, orlistat, and the cholesterol-lowering medicines, cholestyramine and colestipol.
Croatian: Moguće je da neki lijekovi ili dodaci prehrani, uključujući umjetne zamjenske masti, mineralna ulja, lijekove za smanjenje tjelesne težine, orlistat te lijekove za snižavanje kolesterola kolestiramin i kolestipol, mogu spriječiti da vitamin D koji je sadržan u lijeku FOSAVANCE uđe u Vaše tijelo.
English: The bioavailability of the 2,800 IU vitamin D3 in FOSAVANCE is similar to 2,800 IU vitamin D3 administered alone.
Croatian: Bioraspoloživost 2800 IU vitamina D3 u lijeku FOSAVANCE slična je onoj kod primjene 2800 IU samog vitamina D3.
English: The alendronate component in the FOSAVANCE (70 mg/2,800 IU) combination tablet and the FOSAVANCE (70 mg/5,600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Croatian: Alendronat sadržan u kombiniranoj FOSAVANCE (70 mg/2800 IU) tableti i kombiniranoj FOSAVANCE (70 mg/5600 IU) tableti bioekvivalentan je alendronatu u tableti od 70 mg.
English: Very common musculoskeletal (bone, muscle or joint) pain which is sometimes severe Common joint swelling Rare osteonecrosis of the jaw
Croatian: Poremećaji mišićnokoštanog 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: FOSAVANCE should not be used during breast-feeding.
Croatian: FOSAVANCE se ne smije primjenjivati tijekom dojenja.
English: BLISTER FOR FOSAVANCE 70 mg/2,800 IU
Croatian: BLISTER ZA FOSAVANCE 70 mg/2800 IU
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR FOSAVANCE 70 mg/5,600 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA FOSAVANCE 70 mg/5600 IU
English: FOSAVANCE 70 mg/5,600 IU tablets EU/1/05/310/006 - 2 tablets EU/1/05/310/007 - 4 tablets EU/1/05/310/008 - 12 tablets
Croatian: FOSAVANCE 70 mg/5600 IU tablete EU/1/05/310/006 - 2 tablete EU/1/05/310/007 - 4 tablete EU/1/05/310/008 - 12 tableta
English: EU/1/05/310/006 (2 tablets) EU/1/05/310/007 (4 tablets) EU/1/05/310/008 (12 tablets)
Croatian: EU/1/05/310/006 (2 tablete) EU/1/05/310/007 (4 tablete) EU/1/05/310/008 (12 tableta)
English: FOSAVANCE 70 mg/5,600 IU tablets
Croatian: FOSAVANCE 70 mg/5600 IU tablete
English: Colloidal silicon dioxide Magnesium stearate (E572) Butylhydroxytoluene (E321) Modified starch (maize) Sodium aluminium silicate (E554)
Croatian: 6.1 Popis pomoćnih tvari mikrokristalična celuloza (E460) laktoza, bezvodna trigliceridi srednje duljine lanca želatina umrežena karmelozanatrij saharoza koloidni silicijev dioksid magnezijev stearat (E572) butilhidroksitoluen (E321) modificirani škrob (kukuruzni) natrijev aluminijev silikat (E554)
English: FOSAVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
Croatian: Zbog nedostatka iskustva FOSAVANCE se ne preporučuje bolesnicama s oštećenjem funkcije bubrega u kojih je klirens kreatinina manji od 35 ml/min.
English: Patients received the lower strength (70 mg/2,800 IU) of FOSAVANCE (n=350) or FOSAMAX (alendronate) 70 mg (n=332) once a week; additional vitamin D supplements were prohibited.
Croatian: Bolesnice su jedanput na tjedan primale FOSAVANCE u nižoj dozi (70 mg/2800 IU) (n=350) ili FOSAMAX (alendronat) u dozi od 70 mg (n=332); dodatni nadomjestak vitamina
English: EU/1/05/310/003 - 6 tablets
Croatian: EU/1/05/310/003 - 6 tableta
English: How to store FOSAVANCE
Croatian: Kako čuvati FOSAVANCE
English: FOSAVANCE 70 mg/5,600 IU tablets are available as modified rectangle-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘270' on the other.
Croatian: FOSAVANCE 70 mg/5600 IU tablete su bijele do gotovo bijele tablete oblika preinačenog pravokutnika s oznakom kosti na jednoj strani i utisnutom oznakom '270' na drugoj.
English: The percentage of patients with vitamin D deficiency (serum 25-hydroxyvitamin D  22.5 nmol/l [ 9 ng/ml]) was significantly reduced by 92 % with FOSAVANCE (70 mg/2,800 IU) vs. alendronate-only (1 % vs 13 %, respectively).
Croatian: Postotak ispitanica s manjkom vitamina D (25-hidroksivitamin D < 22,5 nmol/l [< 9 ng/ml] u serumu) značajno je smanjen za 92% u skupini koja je primala FOSAVANCE (70 mg/2800 IU) naspram skupine koja je primala samo alendronat (1% naspram 13%).
English: EU/1/05/310/004 - 12 tablets
Croatian: EU/1/05/310/004 - 12 tableta
English: The equivalence of intake of 5,600 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 800 IU has not been studied.
Croatian: Nije ispitano odgovara li tjedna doza vitamina D3 od 5600 IU u lijeku FOSAVANCE dnevnom doziranju vitamina D od 800 IU.
English: FOSAVANCE 70 mg/2,800 IU tablets FOSAVANCE 70 mg/5,600 IU tablets
Croatian: FOSAVANCE 70 mg/2800 IU tablete FOSAVANCE 70 mg/5600 IU tablete
English: How to take FOSAVANCE
Croatian: Kako uzimati FOSAVANCE
English: FOSAVANCE 70 mg/5,600 IU tablets are available in packs containing 2, 4 or 12 tablets.
Croatian: FOSAVANCE 70 mg/5600 IU tablete dostupne su u pakiranjima koja sadrže 2, 4 ili 12 tableta.
English: EU/1/05/310/002 - 4 tablets
Croatian: EU/1/05/310/002 - 4 tablete
English: Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture, have been reported in patients receiving alendronate.
Croatian: U bolesnica koje su uzimale alendronat prijavljene su nuspojave na jednjaku (u pojedinim su slučajevima nuspojave bile teške i zahtijevale hospitalizaciju), poput ezofagitisa, ulkusa i erozija na jednjaku, koje su rijetko bile praćene strikturama jednjaka.
English: FOSAVANCE 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
Croatian: FOSAVANCE 70 mg/5600 IU tablete Aluminij/aluminij blisteri u kutijama sa 2, 4 ili 12 tableta.
English: FOSAVANCE 70 mg/2,800 IU tablets
Croatian: FOSAVANCE 70 mg/2800 IU tablete
English: 5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE and contact your doctor.
Croatian: 5) Prestanite uzimati FOSAVANCE i obratite se svom liječniku ako osjetite teškoće ili bol pri gutanju, bol u prsištu, žgaravicu ili pogoršanje žgaravice.
English: The equivalence of intake of 2,800 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 400 IU has not been studied.
Croatian: Nije ispitano odgovara li tjedna doza vitamina D3 od 2800 IU u lijeku FOSAVANCE dnevnom doziranju vitamina D od 400 IU.
English: FOSAVANCE 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
Croatian: FOSAVANCE 70 mg/2800 IU tablete Aluminij/aluminij blisteri u kutijama sa 2, 4, 6 ili 12 tableta.
English: Frequency in Clinical Trials was similar in the medicinal product and placebo group.
Croatian: Vidjeti dio 4.4 Učestalost u kliničkim ispitivanjima bila je slična u skupini koja je uzimala lijek i u skupini koja je uzimala placebo *Vidjeti dijelove 4.2 i 4.4.
English: FOSAVANCE 70 mg/2,800 IU tablets are available as modified capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘710' on the other.
Croatian: FOSAVANCE 70 mg/2800 IU tablete su bijele do gotovo bijele tablete oblika preinačene kapsule s oznakom kosti na jednoj strani i utisnutom oznakom '710' na drugoj.
English: The percentage of patients with vitamin D insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/l [< 15 ng/ml]) was significantly reduced by 62.5 % with FOSAVANCE (70 mg/2,800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15.
Croatian: Do 15. tjedna postotak bolesnica s nedostatkom vitamina D (25-hidroksivitamin D < 37,5 nmol/l [< 15 ng/ml] u serumu) u skupini koja je primala FOSAVANCE (70 mg/2800 IU) značajno je smanjen za 62,5%, naspram skupine koja je primala samo alendronat (12% naspram 32%).
English: FOSAVANCE 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.
Croatian: FOSAVANCE 70 mg/2800 IU tablete dostupne su u pakiranjima koja sadrže 2, 4, 6 ili 12 tableta.
English: Each FOSAVANCE 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3).
Croatian: Jedna FOSAVANCE 70 mg/5600 IU tableta sadrži 70 mg alendronatne kiseline (u obliku natrijevog trihidrata) i 140 mikrograma (5600 IU) kolekalciferola (vitamina D3).
English: In healthy adult subjects (males and females), following administration of FOSAVANCE 70 mg/5,600 IU after an overnight fast and two hours before a meal, the mean area under the serumconcentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng•hr/ml.
Croatian: Prosječna površina ispod krivulje koncentracija u serumu: vrijeme (AUC0-80 hrs) za vitamin D3 u zdravih je odraslih ispitanika (oba spola) nakon primjene FOSAVANCE 70 mg/5600 IU tableta ujutro natašte i dva sata prije obroka (bez prilagodbe za endogene razine vitamina D3) iznosila 490,2 ng•hr/ml.
English: In healthy adult subjects (males and females), following administration of FOSAVANCE 70 mg/2,800 IU tablets after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng•hr/ml.
Croatian: Prosječna površina ispod krivulje koncentracija u serumu : vrijeme (AUC0-120 hrs) za vitamin D3 u zdravih je odraslih ispitanika (oba spola) nakon primjene FOSAVANCE 70 mg/2800 IU tableta ujutro natašte i dva sata prije obroka (bez prilagodbe za endogene razine vitamina D3) iznosila 296,4 ng•hr/ml.