natgillin/translations-raw huggingface dataset:
• transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment, 
• prolazni simptomi nalik gripi, kao što su bolovi u mišićima, opće loše stanje, a katkad i vrućica,
Patients with malabsorption may not adequately absorb vitamin D3. 
U bolesnica s malapsorpcijom može doći do smanjenja apsorpcije vitamina D3.
EU/1/09/572/004 - 12 tablets 
EU/1/09/572/004 - 12 tableta
Alendronate studies 
Ispitivanja alendronata
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR VANTAVO 70 mg/2,800 IU 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA VANTAVO 70 mg/2800 IU
No additional adverse reactions have been identified for the combination of alendronate and colecalciferol. 
Osim njih nisu bile prepoznate druge nuspojave vezane za kombinaciju alendronata i kolekalciferola.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR VANTAVO 70 mg/5,600 IU 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA VANTAVO 70 mg/5600 IU
• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence, 
• bol u trbuhu, nelagoda u želucu ili podrigivanje nakon jela, zatvor, osjećaj težine u trbuhu ili nadutost, proljev, vjetrovi,
A dental examination with appropriate preventive dentistry should be considered prior to treatment with oral bisphosphonates in patients with poor dental status. 
Prije početka liječenja oralnim bisfosfonatima u bolesnica s lošim dentalnim statusom mora se razmotriti stomatološki pregled uz primjenu odgovarajućih preventivnih stomatoloških mjera.
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). 
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).
The following risk factors should be considered when evaluating an individual's risk of developing osteonecrosis of the jaw: 
Pri procjeni rizika od razvoja osteonekroze čeljusti u svake pojedine bolesnice, u obzir se moraju uzeti sljedeći rizični faktori:
The most commonly reported adverse reactions are upper gastrointestinal adverse reactions including abdominal pain, dyspepsia, oesophageal ulcer, dysphagia, abdominal distension and acid regurgitation 
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%).
Very common musculoskeletal (bone, muscle or joint) pain which is sometimes severe Common joint swelling Rare osteonecrosis of the jaw 
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
• narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach), 
• suženje jednjaka (jednjak je cijev koja spaja usta sa želucem),
Musculoskeletal pain 
Bolovi u mišićno-koštanom sustavu
Relative to an intravenous reference dose, the oral mean bioavailability of alendronate in women was 0.64 % for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardised breakfast. 
U usporedbi s intravenskom referentnom dozom, prosječna bioraspoloživost u žena nakon peroralne primjene alendronata ujutro natašte dva sata prije standardiziranog doručka u dozama od 5 mg do 70 mg bila je 0,64%.
Activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected. 
Inhibirana je aktivnost osteoklasta, bez učinka na nakupljanje osteoklasta ili njihovo vezanje za kost.
Patients received the lower strength (70 mg/2800 IU) of VANTAVO (n=350) or FOSAMAX (alendronate) 70 mg (n=332) once a week; additional vitamin D supplements were prohibited. 
Bolesnice su jedanput na tjedan primale VANTAVO u nižoj dozi (70 mg/2800 IU) (n=350) ili FOSAMAX (alendronat) u dozi od 70 mg (n=332); dodatni nadomjestak vitamina
There were no differences in mean serum calcium, phosphate, or 24-hour urine calcium between treatment groups. 
Dvije se skupine nisu razlikovale u srednjim vrijednostima koncentracije kalcija i fosfata u serumu niti 24-satnog kalcija u urinu.
Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager's hump') and loss of mobility. 
Najčešća mjesta prijeloma su kuk, kralježnica ili ručni zglob, a uz bol se kao posljedica mogu pojaviti i teži problemi kao što su pogrbljeno držanje (grbavost) i gubitak pokretljivosti.
VANTAVO 70 mg/5,600 IU tablets 
VANTAVO 70 mg/5600 IU tablete
It is likely that certain medicines or food additives may prevent the vitamin D in VANTAVO from getting into your body, including artificial fat substitutes, mineral oils, the weight loss medicine, orlistat, and the cholesterol-lowering medicines, cholestyramine and colestipol. 
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 VANTAVO uđe u Vaše tijelo.
There was a 48 % reduction (alendronate 3.2 % vs placebo 6.2 %) in the proportion of patients treated with alendronate experiencing one or more vertebral fractures relative to those treated with placebo. 
Udio ispitanica s jednostrukim ili višestrukim prijelomom kralježnice bio je manji za 48% u skupini liječenoj alendronatom s obzirom na placebo (alendronat 3,2% naspram placebo 6,2%).
If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of alendronate. 
Moguće je da će hrana i napici (uključujući mineralnu vodu), nadomjesci kalcija, antacidi i neki peroralni lijekovi, ako se uzmu istodobno s alendronatom, utjecati na njegovu apsorpciju.
• tiredness; swelling in the hands or legs. 
• umor, oticanje šaka ili nogu.
It is important to maintain good oral hygiene when being treated with VANTAVO. 
Tijekom liječenja lijekom VANTAVO važno je održavati dobru higijenu usne šupljine.
After 24-weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher in the Vitamin D3 5,600 group (69 nmol/l [27.6 ng/ml]) than in the Vitamin D3 2,800 group (64 nmol/l [25.5 ng/ml]). 
D u serumu bile su značajno više u skupini Vitamin D3 5600 (69 nmol/l [27,6 ng/ml]) nego u skupini Vitamin D3 2800 (64 nmol/l [25,5 ng/ml]).
The effects of alendronate on bone mass and fracture incidence in post-menopausal women were examined in two initial efficacy studies of identical design (n=994) as well as in the Fracture Intervention Trial (FIT: n=6,459). 
U dva rana istovjetna ispitivanja djelotvornosti (n=994), kao i u ispitivanju pod nazivom Fracture Intervention Trial (FIT: n=6459) ispitivalo se djelovanje alendronata na koštanu masu i incidenciju prijeloma u žena u postmenopauzi.
VANTAVO should not be used during breast-feeding. 
VANTAVO se ne smije primjenjivati tijekom dojenja.
VANTAVO tablet whole with a full glass of water only (not mineral water) (not less than 
VANTAVO tabletu s punom čašom obične vode (ne mineralne vode) (najmanje 200 ml) kako bi se VANTAVO pravilno apsorbirao.
• irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach, 
• nadraženost ili upala jednjaka (jednjak je cijev koja spaja usta sa želucem) ili želuca,
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. 
Kod liječenja bisfosfonatima prijavljeni su netipični suptrohanterični prijelomi i prijelomi dijafize femura, poglavito u bolesnica koje su se dugotrajno liječile zbog osteoporoze.
• headache; dizziness, 
• glavobolja, omaglica,
• you suffer from kidney problems, 
• imate tegobe s bubrezima,
Musculoskeletal and connective tissue disorders 
Johnsonov sindrom i toksičnu epidermalnunekrolizu
The percentage of patients with vitamin D insufficiency was 5.4 % in the Vitamin D3 2,800 group vs. 3.2 % in the Vitamin D3 5,600 group through the 24-week extension. 
Tijekom 24-tjednog nastavka ispitivanja postotak bolesnica s nedostatkom vitamina D bio je 5,4% u skupini Vitamin D3 2800 u odnosu na 3,2% u skupini Vitamin D3 5600.
As we get older our skin makes less vitamin D. Too little vitamin D may lead to bone loss and osteoporosis. 
Kako starimo, u našoj se koži stvara sve manje vitamina D.
VANTAVO is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience. 
Zbog nedostatka iskustva VANTAVO se ne preporučuje bolesnicama s oštećenjem funkcije bubrega u kojih je klirens kreatinina manji od 35 ml/min.
The equivalence of intake of 5,600 IU of vitamin D3 weekly in VANTAVO to daily dosing of vitamin D 800 IU has not been studied. 
Nije ispitano odgovara li tjedna doza vitamina D3 od 5600 IU u lijeku VANTAVO dnevnom doziranju vitamina D od 800 IU.
Colloidal silicon dioxide Magnesium stearate (E572) Butyl hydroxytoluene (E321) Modified starch (maize) Sodium aluminium silicate (E554) 
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)
VANTAVO 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. 
VANTAVO 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.
Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer who are receiving treatment regimens including primarily intravenously administered bisphosphonates. 
U bolesnica s rakom liječenih uglavnom intravenskom primjenom bisfosfonata prijavljena je osteonekroza čeljusti, u pravilu povezana s vađenjem zuba i/ili lokalnom infekcijom (uključujući osteomijelitis).
Very rare (may affect up to 1 in 10,000 people): 
Vrlo rijetke (mogu se javiti u manje od 1 na 10 000 osoba):
Frequency in Clinical Trials was similar in the medicinal product and placebo group. 
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.
VANTAVO 70 mg/2800 IU tablets VANTAVO 70 mg/5,600 IU tablets 
VANTAVO 70 mg/2800 IU tablete VANTAVO 70 mg/5600 IU tablete
VANTAVO 70 mg/2800 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. 
VANTAVO 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.
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 VANTAVO (70 mg/2800 IU) vs. alendronate-only (1 % vs 13 %, respectively). 
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 VANTAVO (70 mg/2800 IU) naspram skupine koja je primala samo alendronat (1% naspram 13%).
VANTAVO 70 mg/5,600 IU tablets are available in packs containing 2, 4 or 12 tablets. 
VANTAVO 70 mg/5600 IU tablete dostupne su u pakiranjima koja sadrže 2, 4 ili 12 tableta.
Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose. 
Predoziranje nakon peroralne primjene može uzrokovati hipokalcijemiju, hipofosfatemiju i nuspojave u gornjem dijelu gastrointestinalnog trakta kao što su nadražen želudac, žgaravica, ezofagitis, gastritis ili ulkus.
This medicinal product should not be used in children less than 18 years of age because no data are available for the alendronic acid/colecalciferol combination. 
S obzirom da nema dostupnih podataka o primjeni kombinacije alendronatne kiseline/kolekalciferola, ovaj lijek se ne smije davati djeci mlađoj od 18 godina.
• taste disturbance. 
• promjena osjeta okusa.
EU/1/09/572/006 (2 tablets) EU/1/09/572/007 (4 tablets) EU/1/09/572/008 (12 tablets) 
EU/1/09/572/006 (2 tablete) EU/1/09/572/007 (4 tablete) EU/1/09/572/008 (12 tableta)
EU/1/09/572/001 (2 tablets) EU/1/09/572/002 (4 tablets) EU/1/09/572/003 (6 tablets) EU/1/09/572/004 (12 tablets) 
EU/1/09/572/001 (2 tablete) EU/1/09/572/002 (4 tablete) EU/1/09/572/003 (6 tableta) EU/1/09/572/004 (12 tableta)
VANTAVO 70 mg/5,600 IU tablets EU/1/09/572/006 - 2 tablets EU/1/09/572/007 - 4 tablets EU/1/09/572/008 - 12 tablets 
VANTAVO 70 mg/5600 IU tablete EU/1/09/572/006 - 2 tablete EU/1/09/572/007 - 4 tablete EU/1/09/572/008 - 12 tableta
The therapeutic equivalence of alendronate once weekly 70 mg (n=519) and alendronate 10 mg daily (n=370) was demonstrated in a one-year multicentre study of post-menopausal women with osteoporosis. 
U jednogodišnjem multicentričnom ispitivanju provedenom u žena u postmenopauzi s osteoporozom dokazana je terapijska istovrijednost alendronata u dozi od 70 mg jedanput na tjedan (n=519) i alendronata u dozi od 10 mg jedanput na dan (n=370).
How to store VANTAVO 
Kako čuvati VANTAVO
VANTAVO 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets. 
VANTAVO 70 mg/5600 IU tablete Aluminij/aluminij blisteri u kutijama sa 2, 4 ili 12 tableta.
The equivalence of intake of 2800 IU of vitamin D3 weekly in VANTAVO to daily dosing of vitamin D 400 IU has not been studied. 
Nije ispitano odgovara li tjedna doza vitamina D3 od 2800 IU u lijeku VANTAVO dnevnom doziranju vitamina D od 400 IU.
Rare (may affect up to 1 in 1,000 people): 
Rijetke (mogu se javiti u manje od 1 na 1000 osoba):
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. 
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.
VANTAVO 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets. 
VANTAVO 70 mg/2800 IU tablete Aluminij/aluminij blisteri u kutijama sa 2, 4, 6 ili 12 tableta.
A. MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Urine and serum calcium should be monitored in these patients. 
U tih se bolesnica mora pratiti koncentracija kalcija u serumu i mokraći.
VANTAVO 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets. 
VANTAVO 70 mg/2800 IU tablete dostupne su u pakiranjima koja sadrže 2, 4, 6 ili 12 tableta.
VANTAVO 70 mg/2,800 IU tablets 
VANTAVO 70 mg/2800 IU tablete
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking VANTAVO and contact your doctor. 
5) Prestanite uzimati VANTAVO i obratite se svom liječniku ako osjetite teškoće ili bol pri gutanju, bol u prsištu, žgaravicu ili pogoršanje žgaravice.
In studies, rats given high doses showed an increased incidence of incomplete foetal ossification. 
Istraživanja su također ukazala na povećanu incidenciju nepotpune osifikacije fetusa ženki štakora koje su primale visoke doze lijeka.
VANTAVO 70 mg/2800 IU tabletsVANTAVO 70 mg/5,600 IU tablets Alendronic acid / colecalciferol 
VANTAVO 70 mg/2800 IU tablete VANTAVO 70 mg/5600 IU tablete alendronatna kiselina/kolekalciferol
In healthy adult subjects (males and females), following administration of VANTAVO 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. 
Prosječna površina ispod krivulje koncentracija u serumu: vrijeme (AUC0-80 hrs) za vitamin D3 u zdravih je odraslih ispitanika (oba spola) nakon primjene VANTAVO 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.
If you get any side effects, talk to your doctor or pharmacist. 
Primijetite li ove simptome, obratite se svom liječniku i stomatologu.
Pharmacokinetic properties 
5.2 Farmakokinetička svojstva
At doses far higher than the human therapeutic range, reproductive toxicity has been observed in animal studies. 
Reproduktivna toksičnost opažena je u istraživanjima na životinjama koje su primale doze daleko više od terapijskoga raspona za ljude.
In healthy adult subjects (males and females), following administration of VANTAVO 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. 
Prosječna površina ispod krivulje koncentracija u serumu : vrijeme (AUC0-120 hrs) za vitamin D3 u zdravih je odraslih ispitanika (oba spola) nakon primjene VANTAVO 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.
Each VANTAVO 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3) 
Jedna VANTAVO 70 mg/5600 IU tableta sadrži 70 mg alendronatne kiseline (u obliku natrijevog trihidrata) i 140 mikrograma (5600 IU) kolekalciferola (vitamina D3).
Modified capsule-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '710' on the other. 
Bijele do gotovo bijele tablete oblika preinačene kapsule s oznakom kosti na jednoj strani i utisnutom oznakom '710' na drugoj.
70 mg/2800 IU tablets alendronic acid/colecalciferol 
70 mg/2800 IU tablete alendronatna kiselina/kolekalciferol
Each VANTAVO 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) colecalciferol (vitamin D3). 
Jedna VANTAVO 70 mg/2800 IU tableta sadrži 70 mg alendronatne kiseline (u obliku natrijevog trihidrata) i 70 mikrograma (2800 IU) kolekalciferola (vitamina D3).
The effect of the lower dose of VANTAVO (alendronate 70 mg/vitamin D3 2,800 IU) plus an additional 2,800 IU Vitamin D3 for a total of 5,600 IU (the amount of vitamin D3 in the higher dose of VANTAVO) once weekly was demonstrated in a 24-week, extension study that enrolled 619 osteoporotic post-menopausal women. 
U 24-tjednom nastavku ispitivanja koje je uključilo 619 žena u postmenopauzi s osteoporozom dokazan je učinak niže doze lijeka VANTAVO (alendronat 70 mg/vitamin D3 2800 IU) uz dodatak 2800 IU vitamina D3, što čini ukupno 5600 IU (količina vitamina D3 u višoj dozi lijeka VANTAVO) jedanput na tjedan.
After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26 %) in the VANTAVO (70 mg/2800 IU) group (56 nmol/l [23 ng/ml]) than in the alendronate-only group (46 nmol/l [18.2 ng/ml]). 
D u serumu bile su značajno više (26%) u skupini koja je primala VANTAVO (70 mg/2800 IU) (56 nmol/l [23 ng/ml]) u odnosu na skupinu koja je primala samo alendronat (46 nmol/l [18,2 ng/ml]).
Modified rectangle-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '270' on the other. 
Bijele do gotovo bijele tablete oblika preinačenog pravokutnika s oznakom kosti na jednoj strani i utisnutom oznakom '270' na drugoj.
insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/l [< 15 ng/ml]) was significantly reduced by 62.5 % with VANTAVO (70 mg/2800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15. 
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 VANTAVO (70 mg/2800 IU) značajno je smanjen za 62,5%, naspram skupine koja je primala samo alendronat (12% naspram 32%).
BLISTER FOR VANTAVO 70 mg/2,800 IU 
BLISTER ZA VANTAVO 70 mg/2800 IU tablete
and cumulative dose 
SAŽETAK OPISA SVOJSTAVA LIJEKA
Very rare osteonecrosis of the external auditory canal 
Poremećaji uha i labirinta često vrtoglavica vrlo rijetko osteonekroza vanjskog slušnog kanala (nuspojava skupine bisfosfonata)
THU 
C.
70 mg/5600 IU tablets alendronic acid/colecalciferol 
70 mg/5600 IU tablete alendronatna kiselina/kolekalciferol
VANTAVO 70 mg/5600 IU tablets alendronic acid /colecalciferol 
VANTAVO 70 mg/5600 IU tablete alendronatna kiselina/kolekalciferol
Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3). 
Jedna tableta sadrži 70 mg alendronatne kiseline (u obliku natrijevog trihidrata) i 140 mikrograma (5600 IU) kolekalciferola (vitamina D3).
Vitamin D3 may increase the magnitude of hypercalcaemia and/or hypercalciuria when administered to patients with disease associated with unregulated overproduction of calcitriol (e.g. leukaemia, lymphoma, sarcoidosis). 
U bolesnica čija je bolest povezana s nereguliranom hiperprodukcijom kalcitriola (npr. leukemija, limfom, sarkoidoza), vitamin D3 može pojačati hiperkalcijemiju i/ili hiperkalciuriju.
VANTAVO 70 mg/2,800 IU tablets EU/1/09/572/001 - 2 tablets 
VANTAVO 70 mg/2800 IU tablete EU/1/09/572/001 - 2 tablete EU/1/09/572/002 - 4 tablete EU/1/09/572/003 - 6 tableta
Other side effects include 
Ostale nuspojave uključuju
VANTAVO 70 mg/2800 IU tablets alendronic acid /colecalciferol 
VANTAVO 70 mg/2800 IU tablete alendronatna kiselina/kolekalciferol
Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) colecalciferol (vitamin D3). 
Jedna tableta sadrži 70 mg alendronatne kiseline (u obliku natrijevog trihidrata) i 70 mikrograma (2800 IU) kolekalciferola (vitamina D3).
Vitamin D toxicity has not been documented during chronic therapy in generally healthy adults at a dose less than 10,000 IU/day. 
U kroničnoj primjeni u zdravih odraslih osoba pri dozama nižim od 10 000 IU na dan nisu zabilježeni toksični učinci vitamina D.
Uncommon (may affect up to 1 in 100 people): 
Manje česte (mogu se javiti u manje od 1 na 100 osoba):
Common headache, dizziness Uncommon dysgeusia 
Poremećaji živčanog sustava često glavobolja, omaglica manje često disgeuzija
No dose adjustment is necessary for patients with a creatinine clearance greater than 35 ml/min. 
U bolesnica u kojih je klirens kreatinina veći od 35 ml/min nije potrebno prilagođavati dozu.
FRI 
Nuspojava
The body can only absorb calcium properly from our food if it has enough vitamin D. Very few foods contain vitamin D. The main source is through exposure to summer sunlight, which makes vitamin D in our skin. 
Tijelo može apsorbirati dovoljno kalcija iz hrane samo uz dovoljne količine vitamina D.