FrancophonIA/ELRC3.0 huggingface dataset:
English: Take one VANTAVO tablet once a week.
Slovenian: Vzemite eno tableto VANTAVO enkrat na teden.
English: If you miss a dose, take only one VANTAVO tablet on the morning after you remember.
Slovenian: Če pozabite vzeti odmerek, vzemite le eno tableto VANTAVO naslednje jutro, potem ko se spomnite.
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.
Slovenian: Povprečna maksimalna serumska koncentracija (Cmax) vitamina D3 je znašala 12,2 ng/ml, mediana časa do maksimalne serumske koncentracije (Tmax) pa je bila 10,6 ur.
English: They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
Slovenian: Ne vzemite dveh tablet na isti dan. Nadaljujte z jemanjem ene tablete enkrat na teden, kot ste prvotno načrtovali, na izbrani dan.
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.
Slovenian: Povprečna maksimalna serumska koncentracija (Cmax) vitamina D3 je znašala 5,9 ng/ml, mediana časa do maksimalne serumske koncentracije (Tmax) pa je bila 12 ur.
English: What is VANTAVO used for?
Slovenian: Za kaj uporabljamo zdravilo VANTAVO?
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: VANTAVO is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
Slovenian: Bolnikom z okvaro ledvic, pri katerih je kreatininski očistek manjši od 35 ml/min, zdravila VANTAVO zaradi pomanjkanja izkušenj ne priporočamo.
English: Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture.
Slovenian: Zlomi so pogosto obojestranski; zato je treba pri bolnikih, ki so utrpeli zlom srednjega dela stegnenice in se zdravijo z bisfosfonati, pregledati tudi kontralateralno stegnenico.
English: • you suffer from kidney problems,
Slovenian: • če imate težave z ledvicami,
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake Uporabno do oz. EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Conversion to the active calcium-mobilizing hormone 1,25-dihydroxyvitamin D3 (calcitriol) in the kidney is tightly regulated.
Slovenian: Pretvorba v aktivni 1,25-dihidroksivitamin D3 (kalcitriol), ki mobilizira kalcij, poteka v ledvicah in je natančno nadzorovana.
English: • you have poor dental health, gum disease, a planned dental extraction or you don't receive routine dental care,
Slovenian: • če imate slabo stanje zob, bolezen dlesni, če nameravate na izdrtje zoba ali če nimate rednih zobozdravniških pregledov,
English: You must wait at least 30 minutes before taking any food and beverages except water.
Slovenian: Preden zaužijete kakršno koli hrano ali pijačo, razen vode, morate počakati vsaj 30 minut.
English: Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4).
Slovenian: V kolikor je vnos s hrano nezadosten, morajo bolniki prejemati dodatke kalcija (glejte poglavje 4.4).
English: Vitamin D3 is converted to 25-hydroxyvitamin D3 in the liver, and stored until needed.
Slovenian: Vitamin D3 se v jetrih pretvori v 25-hidroksivitamin D3, nato pa se uskladišči, dokler ni potreben.
English: VANTAVO should not be used during breast-feeding.
Slovenian: Zdravila VANTAVO se med dojenjem ne sme uporabljati.
English: Do not crush or chew the tablet or allow it to dissolve in your mouth because of the possibility of mouth ulceration.
Slovenian: Tablete ne zdrobite, ne žvečite in ne raztapljajte v ustih, saj obstaja možnost nastanka razjede v ustih.
English: Vitamin D3 is rapidly distributed mostly to the liver where it undergoes metabolism to 25-hydroxyvitamin D3, the major storage form.
Slovenian: Vitamin D3 se hitro porazdeli večinoma v jetra, kjer se presnovi v 25-hidroksivitamin D3, glavno skladiščno obliko.
English: VANTAVO is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3.
Slovenian: Zdravilo VANTAVO je tableta, ki vsebuje dve učinkovini: alendronsko kislino (splošno poimenovano alendronat) in holekalciferol oziroma vitamin D3.
English: Also contains: lactose and sucrose.
Slovenian: Vsebuje tudi: laktozo in saharozo.
English: VANTAVO 70 mg 2800 IU
Slovenian: VANTAVO 70 mg 2800 i.e.
English: 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.
Slovenian: Če jih bolnik vzame sočasno z alendronatom, lahko hrana in pijače (vključno z mineralno vodo), dodatki kalcija, antacidi in nekatera peroralna zdravila vplivajo na njegovo absorpcijo.
English: 3) Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet.
Slovenian: 3) Potem, ko ste pogoltnili tableto, se ne ulezite, ampak še vsaj 30 minut ostanite v pokončnem položaju (sede, stoje ali hodeč).
English: Patients with malabsorption may not adequately absorb vitamin D3.
Slovenian: Absorpcija vitamina D3 je pri bolnikih z malabsorpcijo lahko premajhna.
English: Alendronate studies
Slovenian: Študije z alendronatom
English: Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Slovenian: Lečeči zdravnik naj zdravljenje prilagodi vsakemu posameznemu bolniku glede na njegovo oceno razmerja koristi/tveganja.
English: Colecalciferol
Slovenian: Holekalciferol
English: You may be advised to have a dental check-up before starting treatment with VANTAVO.
Slovenian: Zdravnik vam bo lahko pred začetkom zdravljenja z zdravilom VANTAVO svetoval zobozdravniški pregled.
English: Do not take VANTAVO
Slovenian: Ne jemljite zdravila VANTAVO
English: • bone, muscle and/or joint pain which is sometimes severe.
Slovenian: • bolečine v kosteh, mišicah in/ali sklepih, ki so včasih hude
English: The bioavailability of the 5,600 IU vitamin D3 in VANTAVO is similar to 5,600 IU vitamin D3 administered alone.
Slovenian: Biološka uporabnost 5.600 i.e. vitamina D3 v zdravilu VANTAVO je podobna kot pri zaužitju 5.600 i.e. vitamina D3 samega.
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.
Slovenian: Delež bolnic s pomanjkanjem vitamina D je bil v skupini "Vitamin D3 2.800" 0,3 % in v skupini "Vitamin D3 5.600" 0 %.
English: VANTAVO is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see section 4.2).
Slovenian: Bolnikom, pri katerih je kreatininski očistek manjši od 35 ml/min, zdravila VANTAVO ne priporočamo (glejte poglavje 4.2).
English: • rash; redness of the skin,
Slovenian: • izpuščaj, rdečina kože
English: No evidence of saturation of bone uptake was found after chronic dosing with cumulative intravenous doses up to 35 mg/kg in animals.
Slovenian: Po kroničnem odmerjanju kumulativnih intravenskih odmerkov do 35 mg/kg pri živalih niso našli nobenih dokazov o nasičenju privzema v kosti.
English: Marketing Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Merck Sharp & Dohme B.V.
English: Excipients with known effect Each tablet contains 63 mg lactose (as lactose anhydrous) and 16 mg sucrose.
Slovenian: Pomožne snovi z znanim učinkom Ena tableta vsebuje 63 mg laktoze (v obliki brezvodne laktoze) in 16 mg saharoze.
English: Bioavailability was negligible whether alendronate was administered with, or up to two hours after, a standardised breakfast.
Slovenian: Pri jemanju alendronata skupaj s standardiziranim zajtrkom ali do dve uri po njem je bila biološka uporabnost zanemarljiva.
English: Osteoporosis is a thinning and weakening of the bones.
Slovenian: Osteoporoza je bolezen, zaradi katere postanejo kosti tanjše in šibkejše.
English: Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting this medicinal product.
Slovenian: Pred začetkom jemanja tega zdravila je treba učinkovito zdraviti tudi ostale bolezni, ki vplivajo na presnovo mineralov (kot npr. pomanjkanje vitamina D in hipoparatiroidizem).
English: 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.
Slovenian: Bolnice so enkrat tedensko dobivale manjšo jakost (70 mg/2.800 i.e.) zdravila VANTAVO (n = 350) ali zdravilo FOSAMAX (alendronat) 70 mg (n = 332); jemanje dodatkov vitamina D je bilo prepovedano.
English: VANTAVO 70 mg 5600 IU
Slovenian: VANTAVO 70 mg 5600 i.e.
English: ; atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
Slovenian: , atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice (za bisfosfonate značilen neželeni učinek)
English: • abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,
Slovenian: • bolečine v trebuhu, neprijeten občutek v želodcu ali spahovanje po jedi, zaprtje, občutek polnega ali napihnjenega želodca, driska, vetrovi
English: 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.
Slovenian: Telo lahko pravilno absorbira kalcij iz hrane le, če je na voljo dovolj vitamina D. Vitamin D se nahaja le v redkih živilih.
English: The bioavailability of the 2800 IU vitamin D3 in VANTAVO is similar to 2800 IU vitamin D3 administered alone.
Slovenian: Biološka uporabnost 2.800 i.e. vitamina D3 v zdravilu VANTAVO je podobna kot pri zaužitju 2.800 i.e. vitamina D3 samega.
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.
Slovenian: Po enem letu se je v skupini, ki je jemala 70 mg odmerek enkrat tedensko, MKG ledvene hrbtenice glede na izhodiščno vrednost zvišala povprečno za 5,1 % (95 % interval zaupanja: 4,8 %, 5,4 %), v skupini, ki je jemala 10 mg odmerek enkrat dnevno, pa povprečno za 5,4 % (95 % interval zaupanja: 5,0 %, 5,8 %).
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.
Slovenian: Pri bolnikih, pri katerih obstaja sum na atipičen zlom stegnenice, je treba razmisliti o prekinitvi zdravljenja z bisfosfonati do pregleda, na katerem bo ovrednoteno razmerje med koristmi in tveganji za posameznega bolnika.
English: Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Slovenian: Zaradi nevarnosti draženja požiralnika se bruhanja ne sme izzvati.
English: Excipients with known effect Each tablet contains 62 mg lactose (as lactose anhydrous) and 8 mg sucrose.
Slovenian: Pomožne snovi z znanim učinkom Ena tableta vsebuje 62 mg laktoze (v obliki brezvodne laktoze) in 8 mg saharoze.
English: No dose adjustment is necessary for patients with a creatinine clearance greater than 35 ml/min.
Slovenian: Pri bolnikih, pri katerih je kreatininski očistek večji od 35 ml/min, prilagoditev odmerka ni potrebna.
English: What VANTAVO contains
Slovenian: Kaj vsebuje zdravilo VANTAVO
English: 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.
Slovenian: Vpliv manjšega odmerka zdravila VANTAVO (alendronat 70 mg/vitamin D3 2.800 i.e.) in dodatnih 2.800 i.e. vitamina D3, kar pomeni skupaj 5.600 i.e. (količina vitamina D3 v večjem odmerku zdravila VANTAVO), enkrat tedensko, so ugotavljali v 24-tedenski podaljšani študiji, v katero je bilo vključenih 619 žensk s pomenopavzalno osteoporozo.
English: The effect of the lower dose of VANTAVO (alendronate 70 mg/vitamin D3 2800 IU) on vitamin D status was demonstrated in a 15-week, multinational study that enrolled 682 osteoporotic postmenopausal women (serum 25-hydroxyvitamin D at baseline: mean, 56 nmol/l [22.3 ng/ml]; range, 22.5-225 nmol/l [9-90 ng/ml]).
Slovenian: Vpliv manjšega odmerka zdravila VANTAVO (alendronat 70 mg/vitamin D3 2.800 i.e.) na status vitamina D so ugotavljali v 15-tedenski, mednarodni študiji, v katero je bilo vključenih 682 žensk s pomenopavzalno osteoporozo (serumski 25-hidroksivitamin D ob začetku študije: povprečna vrednost 56 nmol/l [22,3 ng/ml]; obseg vrednosti 22,5-225 nmol/l [9-90 ng/ml]).
English: Consult your doctor before you begin any exercise programme.
Slovenian: Preden začnete s programom telesne aktivnosti, se posvetujte z zdravnikom.
English: VANTAVO studies
Slovenian: Študije z zdravilom VANTAVO
English: VANTAVO contains lactose and sucrose.
Slovenian: Zdravilo VANTAVO vsebuje laktozo in saharozo.
English: †, peripheral oedema Uncommon transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment
Slovenian: Občasni prehodni simptomi kot pri akutni reakciji (mialgija, oslabelost in redko zvišana telesna temperatura), značilno za začetek zdravljenja
English: • nausea; vomiting,
Slovenian: • siljenje na bruhanje, bruhanje
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.
Slovenian: Alendronat v kombinirani tableti VANTAVO (70 mg/2.800 i.e.) in kombinirani tableti VANTAVO (70 mg/5.600 i.e.) je bioekvivalenten alendronatu v 70 mg tableti.
English: Talk to your doctor or pharmacist before taking VANTAVO if:
Slovenian: Pred začetkom jemanja zdravila VANTAVO se posvetujte z zdravnikom ali farmacevtom:
English: This leaflet was last revised in <{MM/YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: 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.
Slovenian: Ker podatkov o uporabi kombinacije alendronske kisline/holekalciferola ni na voljo, otroci, mlajši od 18 let, tega zdravila ne smejo jemati.
English: • talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Slovenian: • V primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte z zdravnikom.
English: 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.
Slovenian: Delež bolnic, ki so se zdravile z alendronatom in so doživele enega ali več zlomov vretenc, se je v primerjavi s tistimi, ki so dobivale placebo, znižal za 48 % (alendronat 3,2 % v primerjavi s placebom 6,2 %).
English: The active substances are alendronic acid and colecalciferol (vitamin D3).
Slovenian: Učinkovini sta alendronska kislina in holekalciferol (vitamin D3).
English: 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.
Slovenian: Določena zdravila ali dodatki hrani, vključno z umetnimi nadomestki maščob, mineralnimi olji, zdravili za hujšanje, orlistatom in zdravili za zniževanje holesterola, holestiraminom in holestipolom, lahko preprečijo absorpcijo vitamina D iz zdravila VANTAVO v telo.
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).
Slovenian: V tej študiji so se povprečne vrednosti 25-hidroksivitamina D pri bolnicah s pomanjkanjem vitamina D na začetku študije (25-hidroksivitamin D, 22,5 do 37,5 nmol/l [9 do <15 ng/ml]) v skupini, ki je prejemala zdravilo VANTAVO (70 mg/2.800 i.e.) (n = 75), v 15. tednu zvišale s 30 nmol/l (12,1 ng/ml) na 40 nmol/l (15,9 ng/ml), v skupini, ki je prejemala le alendronat (n = 70) pa v 15. tednu znižale s
English: Preclinical studies have shown preferential localisation of alendronate to sites of active resorption.
Slovenian: Predklinične študije so pokazale, da se alendronat porazdeljuje predvsem v predelih, kjer poteka aktivna resorpcija.
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).
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Pri uporabi zdravila VANTAVO so poročali o neželenih učinkih (na primer zamegljenem vidu, omotici in hudih bolečinah v kosteh, mišicah ali sklepih), ki lahko vplivajo na vašo sposobnost vožnje ali upravljanja strojev (glejte poglavje 4).
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.
Slovenian: Bolnik tablete ne sme zdrobiti, žvečiti ali je raztopiti v ustih, ker obstaja nevarnost razjede v ustih in žrelu.
English: • VANTAVO should not be taken at bedtime or before arising for the day.
Slovenian: • Bolnik zdravila VANTAVO ne sme vzeti pred spanjem ali preden zjutraj vstane.
English: VANTAVO is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Slovenian: Zdravilo VANTAVO je indicirano za zdravljenje pomenopavzalne osteoporoze pri ženskah s tveganjem za pomanjkanje vitamina D. Zdravilo zmanjša tveganje za vertebralne zlome in za zlome kolka.
English: 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.
Slovenian: Ekvivalentnost vnosa 5.600 i.e. vitamina D3 tedensko z zdravilom VANTAVO in 800 i.e. vitamina D pri dnevnemu odmerjanju ni bila preučevana.
English: 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.
Slovenian: Pri zdravih odraslih preiskovancih (moških in ženskah) je po zaužitju VANTAVO 70 mg/5.600 i.e. tablet zjutraj na tešče in dve uri pred obrokom povprečna površina pod krivuljo serumska koncentracija-čas (AUC0-80 ur) za vitamin D3 (neprilagojen endogenim vrednostim vitamina D3) znašala 490,2 ngh/ml.
English: VANTAVO 70 mg/2,800 IU tablets
Slovenian: VANTAVO 70 mg/2.800 i.e. tablete
English: Rare oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUBs (perforation, ulcers, bleeding)
Slovenian: Redki striktura požiralnika*, razjede ust in žrela*; PUK (perforacije, ulkusi ali krvavitve) v zgornjem delu prebavil
English: 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]).
Slovenian: Po 15 tednih zdravljenja so bile povprečne vrednosti 25-hidroksivitamina D v serumu v skupini, ki je dobivala zdravilo VANTAVO (70 mg/2.800 i.e.), pomembno višje (26 %) (56 nmol/l [23 ng/ml]) kot v skupini, ki je jemala samo alendronat (46 nmol/l [18,2 ng/ml]).
English: Colloidal silicon dioxide Magnesium stearate (E572) Butyl hydroxytoluene (E321) Modified starch (maize) Sodium aluminium silicate (E554)
Slovenian: 6.1 Seznam pomožnih snovi mikrokristalna celuloza (E460) brezvodna laktoza srednjeverižni trigliceridi želatina premreženi natrijev karmelozat saharoza koloidni silicijev dioksid magnezijev stearat (E572) butilhidroksitoluen (E321) modificiran škrob (koruzni) aluminijev natrijev silikat (E554)
English: 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.
Slovenian: Pri zdravih odraslih preiskovancih (moških in ženskah) je po zaužitju VANTAVO 70 mg/2.800 i.e. tablet zjutraj na tešče in dve uri pred obrokom povprečna površina pod krivuljo serumska koncentracija-čas (AUC0-120 ur) za vitamin D3 (neprilagojen endogenim vrednostim vitamina D3) znašala 296,4 ngh/ml.
English: 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.
Slovenian: Ekvivalentnost vnosa 2.800 i.e. vitamina D3 tedensko z zdravilom VANTAVO in 400 i.e. vitamina D pri dnevnemu odmerjanju ni bila preučevana.
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.
Slovenian: Povprečno zvišanje MKG na vratu stegnenice je bilo v skupini, ki je jemala 70 mg odmerek enkrat tedensko, 2,3 %, v skupini, ki je jemala 10 mg odmerek enkrat dnevno, pa 2,9 %.
English: Common abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation Uncommon nausea, vomiting, gastritis, oesophagitis*, oesophageal erosions*, melena
Slovenian: Občasni navzea, bruhanje, gastritis, ezofagitis*, erozije požiralnika*, melena
English: VANTAVO 70 mg/5,600 IU tablets
Slovenian: VANTAVO 70 mg/5.600 i.e. tablete
English: Very rare osteonecrosis of the external auditory canal
Slovenian: Zelo redki osteonekroza zunanjega slušnega kanala (neželeni učinek skupine bisfosfonatov)
English: Once weekly.
Slovenian: enkrat tedensko peroralna uporaba
English: EU/1/09/572/006 (2 tablets) EU/1/09/572/007 (4 tablets) EU/1/09/572/008 (12 tablets)
Slovenian: EU/1/09/572/006 (2 tableti) EU/1/09/572/007 (4 tablete) EU/1/09/572/008 (12 tablet)
English: 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.
Slovenian: Tekom 24-tedenske podaljšane študije je bil delež bolnic s pomanjkanjem vitamina D v skupini "Vitamin D3 2.800" 5,4 % in v skupini "Vitamin D3 5.600" 3,2 %.
English: 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)
Slovenian: EU/1/09/572/001 (2 tableti) EU/1/09/572/002 (4 tablete) EU/1/09/572/003 (6 tablet) EU/1/09/572/004 (12 tablet)
English: • heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing,
Slovenian: • zgaga, težave pri požiranju, bolečine pri požiranju, razjede požiralnika, ki lahko povzročijo bolečine v prsnem košu, zgago ali težko/boleče požiranje