natgillin/translations-raw huggingface dataset:
• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,
• bolečine v trebuhu, neprijeten občutek v želodcu ali spahovanje po jedi, zaprtje, občutek polnega ali napihnjenega želodca, driska, vetrovi
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.
Telo lahko pravilno absorbira kalcij iz hrane le, če je na voljo dovolj vitamina D. Vitamin D se nahaja le v redkih živilih.
The bioavailability of the 2800 IU vitamin D3 in VANTAVO is similar to 2800 IU vitamin D3 administered alone.
Biološka uporabnost 2.800 i.e. vitamina D3 v zdravilu VANTAVO je podobna kot pri zaužitju 2.800 i.e. vitamina D3 samega.
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.
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 %).
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.
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.
Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Zaradi nevarnosti draženja požiralnika se bruhanja ne sme izzvati.
Excipients with known effect Each tablet contains 62 mg lactose (as lactose anhydrous) and 8 mg sucrose.
Pomožne snovi z znanim učinkom Ena tableta vsebuje 62 mg laktoze (v obliki brezvodne laktoze) in 8 mg saharoze.
No dose adjustment is necessary for patients with a creatinine clearance greater than 35 ml/min.
Pri bolnikih, pri katerih je kreatininski očistek večji od 35 ml/min, prilagoditev odmerka ni potrebna.
What VANTAVO contains
Kaj vsebuje zdravilo VANTAVO
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.
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.
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]).
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]).
Consult your doctor before you begin any exercise programme.
Preden začnete s programom telesne aktivnosti, se posvetujte z zdravnikom.
VANTAVO studies
Študije z zdravilom VANTAVO
VANTAVO contains lactose and sucrose.
Zdravilo VANTAVO vsebuje laktozo in saharozo.
†, peripheral oedema Uncommon transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment
Občasni prehodni simptomi kot pri akutni reakciji (mialgija, oslabelost in redko zvišana telesna temperatura), značilno za začetek zdravljenja
• nausea; vomiting,
• siljenje na bruhanje, bruhanje
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.
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.
Talk to your doctor or pharmacist before taking VANTAVO if:
Pred začetkom jemanja zdravila VANTAVO se posvetujte z zdravnikom ali farmacevtom:
This leaflet was last revised in <{MM/YYYY}>.
Navodilo je bilo nazadnje revidirano dne
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.
Ker podatkov o uporabi kombinacije alendronske kisline/holekalciferola ni na voljo, otroci, mlajši od 18 let, tega zdravila ne smejo jemati.
• talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
• V primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte z zdravnikom.
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.
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 %).
The active substances are alendronic acid and colecalciferol (vitamin D3).
Učinkovini sta alendronska kislina in holekalciferol (vitamin D3).
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.
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.
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).
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
Preclinical studies have shown preferential localisation of alendronate to sites of active resorption.
Predklinične študije so pokazale, da se alendronat porazdeljuje predvsem v predelih, kjer poteka aktivna resorpcija.
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).
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).
Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
Bolnik tablete ne sme zdrobiti, žvečiti ali je raztopiti v ustih, ker obstaja nevarnost razjede v ustih in žrelu.
• VANTAVO should not be taken at bedtime or before arising for the day.
• Bolnik zdravila VANTAVO ne sme vzeti pred spanjem ali preden zjutraj vstane.
VANTAVO is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
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.
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.
Ekvivalentnost vnosa 5.600 i.e. vitamina D3 tedensko z zdravilom VANTAVO in 800 i.e. vitamina D pri dnevnemu odmerjanju ni bila preučevana.
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.
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.
VANTAVO 70 mg/2,800 IU tablets
VANTAVO 70 mg/2.800 i.e. tablete
Rare oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUBs (perforation, ulcers, bleeding)
Redki striktura požiralnika*, razjede ust in žrela*; PUK (perforacije, ulkusi ali krvavitve) v zgornjem delu prebavil
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]).
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]).
Colloidal silicon dioxide Magnesium stearate (E572) Butyl hydroxytoluene (E321) Modified starch (maize) Sodium aluminium silicate (E554)
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)
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.
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.
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.
Ekvivalentnost vnosa 2.800 i.e. vitamina D3 tedensko z zdravilom VANTAVO in 400 i.e. vitamina D pri dnevnemu odmerjanju ni bila preučevana.
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.
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 %.
Common abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation Uncommon nausea, vomiting, gastritis, oesophagitis*, oesophageal erosions*, melena
Občasni navzea, bruhanje, gastritis, ezofagitis*, erozije požiralnika*, melena
VANTAVO 70 mg/5,600 IU tablets
VANTAVO 70 mg/5.600 i.e. tablete
Very rare osteonecrosis of the external auditory canal
Zelo redki osteonekroza zunanjega slušnega kanala (neželeni učinek skupine bisfosfonatov)
Once weekly.
enkrat tedensko peroralna uporaba
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 tableti) EU/1/09/572/007 (4 tablete) EU/1/09/572/008 (12 tablet)
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.
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 %.
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 tableti) EU/1/09/572/002 (4 tablete) EU/1/09/572/003 (6 tablet) EU/1/09/572/004 (12 tablet)
• 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,
• zgaga, težave pri požiranju, bolečine pri požiranju, razjede požiralnika, ki lahko povzročijo bolečine v prsnem košu, zgago ali težko/boleče požiranje
Rare (may affect up to 1 in 1,000 people):
Redki (pojavijo se lahko pri največ 1 od 1.000 ljudi):
A dental examination with appropriate preventive dentistry should be considered prior to treatment with oral bisphosphonates in patients with poor dental status.
Pred začetkom zdravljenja s peroralnimi bisfosfonati naj bolniki s slabim stanjem zob po potrebi opravijo preventivni zobozdravniški pregled.
What is VANTAVO?
Kaj je zdravilo VANTAVO?
Your doctor has prescribed VANTAVO to treat your osteoporosis and because you are at risk of vitamin D insufficiency.
Zdravnik vam je predpisal zdravilo VANTAVO za zdravljenje osteoporoze in zato, ker pri vas obstaja tveganje za pomanjkanje vitamina D. Zdravilo zmanjša tveganje za zlome hrbtenice in za zlome kolka pri ženskah po menopavzi.
How to take VANTAVO
Kako jemati zdravilo VANTAVO
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/5.600 i.e. tablete EU/1/09/572/006 - 2 tableti EU/1/09/572/007 - 4 tablete EU/1/09/572/008 - 12 tablet
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.
Poleg bolečin lahko ti zlomi povzročijo tudi znatne težave, kot sta sključena drža (grba) in izguba gibljivosti.
Very common musculoskeletal (bone, muscle or joint) pain which is sometimes severe Common joint swelling Rare osteonecrosis of the jaw
Zelo pogosti mišično-skeletne bolečine (v kosteh, mišicah ali sklepih), ki so včasih hude
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).
Delež bolnic s pomanjkanjem vitamina D (serumski 25-hidroksivitamin D < 22,5 nmol/l [< 9 ng/ml]) je bil v skupini, ki je prejemala zdravilo VANTAVO (70 mg/2.800 i.e.), pomembno nižji (za 92 %) kot v skupini, ki je prejemala le alendronat (1 % oz. 13 %).
There is important additional information about how to take VANTAVO in the package leaflet.
V navodilu za uporabo so pomembne dodatne informacije o jemanju zdravila VANTAVO.
VANTAVO 70 mg/2800 IU tablets VANTAVO 70 mg/5,600 IU tablets
VANTAVO 70 mg/2.800 i.e. tablete VANTAVO 70 mg/5.600 i.e. tablete
VANTAVO 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.
VANTAVO 70 mg/2.800 i.e tablete so na voljo v pakiranjih, ki vsebujejo 2, 4, 6 ali 12 tablet.
VANTAVO 70 mg/5,600 IU tablets are available in packs containing 2, 4 or 12 tablets.
VANTAVO 70 mg/5.600 i.e tablete so na voljo v pakiranjih, ki vsebujejo 2, 4 ali 12 tablet.
2) After getting up for the day and before taking any food, drink, or other medicine, swallow your
2) Potem, ko zjutraj vstanete in še preden zaužijete prvo hrano, pijačo ali katero koli drugo zdravilo, pogoltnite celo tableto VANTAVO samo s polnim kozarcem vode (ne mineralne vode)
Always take VANTAVO exactly as your doctor or pharmacist has told you.
Pri jemanju zdravila VANTAVO natančno upoštevajte navodila zdravnika ali farmacevta.
These side effects may worsen if patients continue to take VANTAVO after developing these symptoms.
Če potem, ko so se že pojavili neželeni učinki, bolnik nadaljuje z jemanjem zdravila VANTAVO, se lahko neželeni učinki še poslabšajo.
You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.
V primeru kakršnih koli težav v ustih ali z zobmi, kot so majavost zob, bolečina ali otekanje, se morate posvetovati z zdravnikom ali zobozdravnikom.
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.
Pri bolnikih, ki so jemali alendronat, so poročali o neželenih pojavih v požiralniku, kot so ezofagitis, razjede in erozije požiralnika, ki jim je redko sledila striktura požiralnika.
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.
Po peroralni uporabi (zjutraj na tešče in dve uri pred standardiziranim zajtrkom) je bila pri ženskah povprečna biološka uporabnost alendronata za odmerke od 5 do 70 mg v primerjavi z intravenskim referenčnim odmerkom 0,64 %.
Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose.
Zaradi prekomernih peroralnih odmerkov lahko pride do hipokalciemije, hipofosfatemije in neželenih učinkov v zgornjem delu prebavil, kot so razdraženost želodca, zgaga, ezofagitis, gastritis ali razjeda.
Very rare (may affect up to 1 in 10,000 people):
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
Common asthenia
Očesne bolezni
Ear and labyrinth disorders
Ušesne bolezni vključno z motnjami labirinta
• headache; dizziness,
• glavobol, omotica
Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain or new or worsening heartburn (see section 4.8).
Bolniku mora naročiti, naj v primeru simptomov draženja požiralnika, kot so disfagija, bolečine pri požiranju ali retrosternalna bolečina, pojav zgage ali poslabšanje le-te, prekine zdravljenje z alendronatom in poišče zdravniško pomoč (glejte poglavje 4.8).
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.
Bolnice v skupini "Vitamin D3 2.800" so prejemale zdravilo VANTAVO (70 mg/2.800 i.e.) (n = 299), bolnice v skupini "Vitamin D3 5.600" pa so prejemale zdravilo VANTAVO (70 mg/2.800 i.e.) in dodatnih 2.800 i.e. vitamina D3 (n = 309) enkrat tedensko; dovoljeni so bili tudi drugi dodatki vitamina D. Po 24 tednih zdravljenja so bile povprečne vrednosti 25-hidroksivitamina D v serumu v skupini "Vitamin D3 5.600" pomembno višje (69 nmol/l [27,6 ng/ml]) kot v skupini "Vitamin D3 2.800" (64 nmol/l [25,5 ng/ml]).
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/5.600 i.e. tablete imajo obliko modificiranega pravokotnika, so bele do skoraj bele barve, na eni strani imajo vtisnjen obris kosti, na drugi pa oznako ‘270'.
Every week, take one VANTAVO tablet on your chosen day.
1) Izberite dan v tednu, ki vam najbolj ustreza, nato pa vsak teden na izbrani dan vzemite eno tableto VANTAVO.
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/2.800 i.e. tablete imajo obliko modificirane kapsule, so bele do skoraj bele barve, na eni strani imajo vtisnjen obris kosti, na drugi pa oznako ‘710'.
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).
Previdnost je potrebna tudi pri bolnikih, ki so imeli v zadnjem obdobju (v preteklem letu) hujše bolezni prebavil, kot na primer peptično razjedo, aktivno krvavitev iz prebavil ali kirurški poseg (razen piloroplastike) v zgornjem delu prebavil (glejte poglavje 4.3).
VANTAVO 70 mg/2800 IU tabletsVANTAVO 70 mg/5,600 IU tablets Alendronic acid / colecalciferol
VANTAVO 70 mg/2.800 i.e. tablete VANTAVO 70 mg/5.600 i.e. tablete alendronska kislina/holekalciferol
VANTAVO 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
VANTAVO 70 mg/2.800 i.e. tablete Pretisni omoti (aluminij/aluminij) v škatlah, ki vsebujejo 2, 4, 6 ali 12 tablet.
The most commonly reported adverse reactions are upper gastrointestinal adverse reactions including abdominal pain, dyspepsia, oesophageal ulcer, dysphagia, abdominal distension and acid regurgitation
Najbolj pogosto so poročali o neželenih učinkih v zgornjem delu prebavil, vključno z bolečino v trebuhu, dispepsijo, razjedo požiralnika, disfagijo, napetim trebuhom in refluksom kisline (> 1 %).
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.
Delež bolnic s pomanjkanjem vitamina D (serumski 25-hidroksivitamin D < 37,5 nmol/l [< 15 ng/ml]) je bil v skupini, ki je prejemala zdravilo VANTAVO (70 mg/2.800 i.e.), v 15. tednu pomembno nižji (za 62,5 %) kot v skupini, ki je prejemala le alendronat (12 % oz. 32 %).
Each VANTAVO 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
Ena VANTAVO 70 mg/2.800 i.e. tableta vsebuje 70 mg alendronske kisline (v obliki natrijevega trihidrata) in 70 mikrogramov (2.800 i.e.) holekalciferola (vitamina D3).
Uncommon (may affect up to 1 in 100 people):
Občasni (pojavijo se lahko pri največ 1 od 100 ljudi):
VANTAVO 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
VANTAVO 70 mg/5.600 i.e. tablete Pretisni omoti (aluminij/aluminij) v škatlah, ki vsebujejo 2, 4 ali 12 tablet.
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)
Ena VANTAVO 70 mg/5.600 i.e. tableta vsebuje 70 mg alendronske kisline (v obliki natrijevega trihidrata) in 140 mikrogramov (5.600 i.e.) holekalciferola (vitamina D3).
70 mg/5600 IU tablets alendronic acid/colecalciferol
70 mg/5.600 i.e. tablete alendronska kislina/holekalciferol
Common alopecia
Pogosti alopecija †, pruritus