natgillin/translations-raw huggingface dataset:
The principal action of 1,25-dihydroxyvitamin D3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.
Glavni učinek 1,25-dihidroksivitamina D3 je povečanje absorpcije kalcija in fosfata v črevesju, uravnava pa tudi količino kalcija v serumu, izločanje kalcija in fosfata skozi ledvice ter tvorbo in resorpcijo kosti.
PARTICULARS TO APPEAR WITHIN THE OUTER PACKAGING (CARTON)
PODATKI, KI MORAJO BITI NAVEDENI NA ZUNANJI OVOJNINI (ŠKATLA)
Bone and mineral metabolism Causes of osteoporosis other than oestrogen deficiency and ageing should be considered.
Presnova kosti in mineralov Poleg pomanjkanja estrogena in staranja je treba upoštevati tudi druge vzroke za osteoporozo.
What VANTAVO looks like and contents of the pack
Izgled zdravila VANTAVO in vsebina pakiranja
In healthy subjects, oral prednisone (20 mg three times daily for five days) did not produce a clinically meaningful change in oral bioavailability of alendronate (a mean increase ranging from 20 % to 44 %).
Pri zdravih preiskovancih peroralni prednizon (20 mg trikrat dnevno, pet dni) ni povzročil klinično pomembne spremembe v biološki uporabnosti po peroralni uporabi alendronata (povprečni porast od 20 % do 44 %).
Non-clinical studies with the combination of alendronate and colecalciferol have not been conducted.
Predklinične študije s kombinacijo alendronata in holekalciferola niso bile izvedene.
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).
Čeprav v obsežnih kliničnih preskušanjih z alendronatom povečanega tveganja niso opazili, so v obdobju trženja zdravila v redkih primerih poročali o razjedah v želodcu in dvanajstniku (nekatere so bile resne in s komplikacijami) (glejte poglavje 4.8).
• a history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures and poorly fitting dentures
• anamnezo bolezni zob, slabo ustno higieno, bolezen dlesni, invazivni zobozdravniški poseg in slabo prilegajočo zobno protezo.
Alendronate sodium is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation.
Natrijev alendronat je bisfosfonat, ki zavira delovanje osteoklastov in s tem kostno resorpcijo, nima pa neposrednega vpliva na proces tvorbe kosti.
Take one tablet once a week.
Vzemite eno tableto enkrat na teden.
Patients may experience certain adverse reactions (for example, blurred vision, dizziness and severe bone muscle or joint pain (see section 4.8)) that may influence the ability to drive and use machines.
Pri bolnikih se lahko pojavijo določeni neželeni učinki (npr. zamegljen vid, omotica in hude bolečine v kosteh, mišicah ali sklepih (glejte poglavje 4.8)), ki lahko vplivajo na sposobnost vožnje in upravljanja strojev.
Vitamin D insufficiency develops when both sunlight exposure and dietary intake are inadequate.
Pomanjkanje vitamina D se pojavi, kadar sta premajhna tako izpostavljenost soncu, kot tudi vnos s hrano.
An Instruction Card is included in the carton for VANTAVO.
V škatli zdravila VANTAVO je priložena kartica z navodili.
It reduces the risk of vertebral and hip fractures.
Zmanjša tveganje za zlome hrbtenice in kolka.
At doses far higher than the human therapeutic range, reproductive toxicity has been observed in animal studies.
Pri odmerkih, ki daleč presegajo terapevtsko območje pri ljudeh, so v študijah na živalih opazili škodljiv vpliv na sposobnost razmnoževanja.
• potency of the bisphosphonate (highest for zoledronic acid), route of administration (see above)
• jakost bisfosfonatov (največja pri zoledronski kislini), pot uporabe (glejte zgoraj) in kumulativni odmerek,
• stomach or peptic ulcers (sometimes severe or with bleeding),
• razjede v želodcu ali dvanajstniku (včasih hude ali s krvavitvijo)
Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
O osteonekrozi čeljusti so poročali tudi pri bolnikih z osteoporozo, ki so prejemali peroralne bisfosfonate.
- Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.
- Nenormalnosti požiralnika in drugi dejavniki, ki upočasnjujejo praznjenje požiralnika, kot sta zožitev ali ahalazija.
In this study, a significant difference was observed in the analysis of the subgroup of osteoporotic women (37 % of the global population who correspond with the above definition of osteoporosis) in the incidence of hip fractures (alendronate 1.0 % vs. placebo 2.2 %, a reduction of 56 %) and in the incidence of  1 vertebral fracture (2.9 % vs. 5.8 %, a reduction of 50 %).
V tej študiji so pri analizi podskupine žensk z osteoporozo (37 % svetovne populacije, ki ustreza že omenjeni definiciji osteoporoze) opazili pomembno razliko v pojavnosti zlomov kolka (alendronat 1,0 % v primerjavi s placebom 2,2 %, 56 % zmanjšanje) in v pojavnosti ≥ 1 zlomov vretenc (2,9 % v primerjavi s 5,8 %, 50 % zmanjšanje).
Bioavailability was decreased similarly to an estimated 0.46 % and 0.39 % when alendronate was administered one hour or half an hour before a standardised breakfast.
Biološka uporabnost se je pri zaužitju alendronata eno uro ali pol ure pred standardiziranim zajtrkom podobno zmanjšala na ocenjenih 0,46 % oz. 0,39 %.
The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms such as pain or discharge, or chronic ear infections.
Možnost osteonekroze zunanjega slušnega kanala je treba upoštevati pri bolnikih, ki prejemajo bisfosfonate in pri katerih se pojavljajo simptomi bolezni ušesa, kot sta bolečina ali izcedek, ali kronična vnetja ušesa.
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.
Terapevtsko ekvivalenco alendronata 70 mg enkrat tedensko (n = 519) in alendronata 10 mg enkrat dnevno (n = 370) so dokazali v enoletni multicentrični študiji pri ženskah s pomenopavzalno osteoporozo.
Alendronate given during pregnancy in rats caused dystocia related to hypocalcaemia (see section 5.3).
Alendronat, ki so ga dajali brejim podganam, je povzročil distocijo, povezano s hipokalciemijo (glejte poglavje 5.3).
Medicines for fits (seizures) (like phenytoin or phenobarbital) may decrease the effectiveness of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Zdravila proti krčem (napadom) (kot sta fenitoin ali fenobarbital) lahko zmanjšajo učinek vitamina D. Pri posameznih bolnikih lahko pride v poštev jemanje dodatkov vitamina D.
VANTAVO is only intended for use in postmenopausal women.
Zdravilo VANTAVO je namenjeno le ženskam po menopavzi.
• Patients should only swallow VANTAVO whole.
• Bolnik mora pogoltniti celo tableto VANTAVO.
The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans.
Povprečni volumen porazdelitve v stanju dinamičnega ravnovesja (brez kosti), je pri ljudeh vsaj 28 litrov.
It is very important that the full dosing instructions are provided to, and are understood by the patient (see section 4.2).
Zelo pomembno je, da se bolnika natančno pouči, kako naj jemlje alendronat, in da bolnik navodila tudi razume (glejte poglavje 4.2).
VANTAVO is effective only if taken when your stomach is empty.
Zdravilo VANTAVO je učinkovito samo, če ga vzamete na tešče.
A small percentage of vitamin D3 undergoes glucuronidation prior to elimination.
Pri majhnem deležu vitamina D3 pred izločanjem pride do glukuronidacije.
The following adverse reactions have been reported during clinical studies and/or post-marketing use with alendronate.
Seznam neželenih učinkov v preglednici Iz kliničnih študij in/ali v obdobju trženja alendronata so poročali o naslednjih neželenih učinkih.
• blurred vision; pain or redness in the eye,
• zamegljen vid, bolečina v očesu ali rdeče oko
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D. Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Olestra, mineralna olja, orlistat in izmenjevalci žolčnih kislin (npr. holestiramin, holestipol) lahko motijo absorpcijo vitamina D. Antikonvulzivi, cimetidin in tiazidi lahko povečajo razgradnjo vitamina D. Pri posameznih bolnikih lahko pride v poštev še dodatno jemanje vitamina D.
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Bolnikom je treba svetovati, naj v času zdravljenja z bisfosfonati sporočijo kakršne koli bolečine v stegnu, kolku ali dimljah, vsakega bolnika z navedenimi simptomi pa je treba pregledati glede nepopolnega zloma stegnenice.
Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive problems.
Določena zdravila za zdravljenje revmatičnih obolenj ali dolgotrajne bolečine, imenovana nesteroidni antirevmatiki (NSAID) (npr: acetilsalicilna kislina ali ibuprofen), lahko povzročijo prebavne motnje.
Studies in animals have shown hypercalcaemia and reproductive toxicity with high doses of vitamin D (see section 5.3).
Študije na živalih so pri velikih odmerkih vitamina D pokazale hiperkalciemijo in vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Therefore, somewhat greater accumulation of alendronate in bone might be expected in patients with impaired renal function (see section 4.2).
Zato se pri bolnikih z okvaro ledvične funkcije pričakuje nekoliko večje kopičenje alendronata v kosteh (glejte poglavje 4.2).
Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking VANTAVO.
Po zaužitju lahko pride do draženja, vnetja ali razjede požiralnika, pogosto z bolečino v prsnem košu, zgago ali oteženim ali bolečim požiranjem, še posebej, če bolnik ne spije polnega kozarca vode in/ali če se uleže prej kot v 30 minutah po zaužitju zdravila VANTAVO.
The mean half-life of vitamin D3 in the serum following an oral dose of VANTAVO (70 mg/2800 IU) is approximately 24 hours.
Povprečni razpolovni čas vitamina D3 v serumu po peroralnem odmerku zdravila VANTAVO (70 mg/2.800 i.e.) je približno 24 ur.
Studies in rats have shown that treatment with alendronate during pregnancy was associated with dystocia in dams during parturition which was related to hypocalcaemia.
Študije na podganah so pokazale, da je bila distocija med porodom zaradi hipokalciemije povezana z zdravljenjem z alendronatom.
Vitamin D toxicity has not been documented during chronic therapy in generally healthy adults at a dose less than 10,000 IU/day.
Toksičnega učinka vitamina D pri sicer na splošno zdravih odraslih, ki so dlje časa dobivali odmerke manj kot 10.000 i.e. dnevno, niso zabeležili.
• pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
• bolečina v ustih in/ali čeljusti, otekanje ali ranice v ustih, odrevenelost ali občutek pritiska v čeljusti ali majanje zoba.
In the initial efficacy studies, the mean BMD increases with alendronate 10 mg/day relative to placebo at three years were 8.8 %, 5.9 % and 7.8 % at the spine, femoral neck and trochanter, respectively.
V začetnih študijah učinkovitosti se je povprečna MKG hrbtenice, vratu stegnenice oz. trohantra pri zdravljenju z alendronatom 10 mg/dan v primerjavi s placebom po treh letih zvišala za 8,8 %, 5,9 % oz. 7,8 %.
If you forget to take VANTAVO
Če ste pozabili vzeti zdravilo VANTAVO
A. MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Alendronate can cause local irritation of the upper gastrointestinal mucosa.
Alendronat lahko povzroči lokalno draženje sluznice zgornjega dela prebavil.
It is likely that food and beverages (including mineral water) will make VANTAVO less effective if taken at the same time.
Hrana in pijače (vključno z mineralno vodo) lahko ob sočasnem zaužitju zmanjšajo učinek zdravila VANTAVO.
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva
The other ingredients are microcrystalline cellulose (E460), lactose anhydrous (see section 2), medium chain triglycerides, gelatin, croscarmellose sodium, sucrose (see section 2), colloidal silicon dioxide, magnesium stearate (E572), butyl hydroxytoluene (E321), modified starch (maize), and sodium aluminium silicate (E554).
Pomožne snovi so: mikrokristalna celuloza (E460), brezvodna laktoza (glejte poglavje 2), srednjeverižni trigliceridi, želatina, premreženi natrijev karmelozat, saharoza (glejte poglavje 2), koloidni silicijev dioksid, magnezijev stearat (E572), butilhidroksitoluen (E321), modificirani škrob (koruzni) in aluminijev natrijev silikat (E554).
This medicinal product contains lactose and sucrose.
To zdravilo vsebuje laktozo in saharozo.
• if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing,
• če imate določene težave s požiralnikom (del prebavne cevi, ki povezuje usta in želodec), kot je njegovo zoženje ali oteženo požiranje,
If you stop taking VANTAVO
Če ste prenehali jemati zdravilo VANTAVO
5 How to store VANTAVO Contents of the pack and other information
Shranjevanje zdravila VANTAVO Vsebina pakiranja in dodatne informacije
Vitamin D3 is rapidly metabolized by hydroxylation in the liver to 25-hydroxyvitamin D3, and subsequently metabolized in the kidney to 1,25-dihydroxyvitamin D3, which represents the biologically active form.
Vitamin D3 se v jetrih s hidroksilacijo hitro presnovi v 25-hidroksivitamin D3, nato pa se v ledvicah presnovi v 1,25-dihidroksivitamin D3, ki je biološko aktivna oblika.
• tiredness; swelling in the hands or legs.
• utrujenost, otekanje dlani ali nog
No specific information is available on the treatment of overdose with alendronate.
Posebnih napotkov o ukrepih pri prekomernem odmerjanju alendronata ni na voljo.
†, pruritus Uncommon rash, erythema Rare rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
Redki izpuščaj z občutljivostjo na svetlobo, hude kožne reakcije, vključno s Stevens-Johnsonovim sindromom in toksično epidermalno nekrolizo
Return to taking one tablet once a week, as originally scheduled on your chosen day.
Nadaljevati morajo z jemanjem ene tablete enkrat na teden na izbrani dan, tako kot so prvotno načrtovali.
Activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected.
Zavrto je delovanje osteoklastov, ne pa tudi njihovo zbiranje ali vezava.
Take one VANTAVO tablet once a week.
Vzemite eno tableto VANTAVO enkrat na teden.
If you miss a dose, take only one VANTAVO tablet on the morning after you remember.
Če pozabite vzeti odmerek, vzemite le eno tableto VANTAVO naslednje jutro, potem ko se spomnite.
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.
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.
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.
Ne vzemite dveh tablet na isti dan. Nadaljujte z jemanjem ene tablete enkrat na teden, kot ste prvotno načrtovali, na izbrani dan.
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.
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.
What is VANTAVO used for?
Za kaj uporabljamo zdravilo VANTAVO?
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
VANTAVO is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
Bolnikom z okvaro ledvic, pri katerih je kreatininski očistek manjši od 35 ml/min, zdravila VANTAVO zaradi pomanjkanja izkušenj ne priporočamo.
Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture.
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.
• you suffer from kidney problems,
• če imate težave z ledvicami,
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
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.
Conversion to the active calcium-mobilizing hormone 1,25-dihydroxyvitamin D3 (calcitriol) in the kidney is tightly regulated.
Pretvorba v aktivni 1,25-dihidroksivitamin D3 (kalcitriol), ki mobilizira kalcij, poteka v ledvicah in je natančno nadzorovana.
• you have poor dental health, gum disease, a planned dental extraction or you don't receive routine dental care,
• če imate slabo stanje zob, bolezen dlesni, če nameravate na izdrtje zoba ali če nimate rednih zobozdravniških pregledov,
You must wait at least 30 minutes before taking any food and beverages except water.
Preden zaužijete kakršno koli hrano ali pijačo, razen vode, morate počakati vsaj 30 minut.
Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4).
V kolikor je vnos s hrano nezadosten, morajo bolniki prejemati dodatke kalcija (glejte poglavje 4.4).
Vitamin D3 is converted to 25-hydroxyvitamin D3 in the liver, and stored until needed.
Vitamin D3 se v jetrih pretvori v 25-hidroksivitamin D3, nato pa se uskladišči, dokler ni potreben.
VANTAVO should not be used during breast-feeding.
Zdravila VANTAVO se med dojenjem ne sme uporabljati.
Do not crush or chew the tablet or allow it to dissolve in your mouth because of the possibility of mouth ulceration.
Tablete ne zdrobite, ne žvečite in ne raztapljajte v ustih, saj obstaja možnost nastanka razjede v ustih.
Vitamin D3 is rapidly distributed mostly to the liver where it undergoes metabolism to 25-hydroxyvitamin D3, the major storage form.
Vitamin D3 se hitro porazdeli večinoma v jetra, kjer se presnovi v 25-hidroksivitamin D3, glavno skladiščno obliko.
VANTAVO is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3.
Zdravilo VANTAVO je tableta, ki vsebuje dve učinkovini: alendronsko kislino (splošno poimenovano alendronat) in holekalciferol oziroma vitamin D3.
Also contains: lactose and sucrose.
Vsebuje tudi: laktozo in saharozo.
VANTAVO 70 mg 2800 IU
VANTAVO 70 mg 2800 i.e.
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.
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.
3) Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet.
3) Potem, ko ste pogoltnili tableto, se ne ulezite, ampak še vsaj 30 minut ostanite v pokončnem položaju (sede, stoje ali hodeč).
Patients with malabsorption may not adequately absorb vitamin D3.
Absorpcija vitamina D3 je pri bolnikih z malabsorpcijo lahko premajhna.
Alendronate studies
Študije z alendronatom
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Lečeči zdravnik naj zdravljenje prilagodi vsakemu posameznemu bolniku glede na njegovo oceno razmerja koristi/tveganja.
Colecalciferol
Holekalciferol
You may be advised to have a dental check-up before starting treatment with VANTAVO.
Zdravnik vam bo lahko pred začetkom zdravljenja z zdravilom VANTAVO svetoval zobozdravniški pregled.
Do not take VANTAVO
Ne jemljite zdravila VANTAVO
• bone, muscle and/or joint pain which is sometimes severe.
• bolečine v kosteh, mišicah in/ali sklepih, ki so včasih hude
The bioavailability of the 5,600 IU vitamin D3 in VANTAVO is similar to 5,600 IU vitamin D3 administered alone.
Biološka uporabnost 5.600 i.e. vitamina D3 v zdravilu VANTAVO je podobna kot pri zaužitju 5.600 i.e. vitamina D3 samega.
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.
Delež bolnic s pomanjkanjem vitamina D je bil v skupini "Vitamin D3 2.800" 0,3 % in v skupini "Vitamin D3 5.600" 0 %.
VANTAVO is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see section 4.2).
Bolnikom, pri katerih je kreatininski očistek manjši od 35 ml/min, zdravila VANTAVO ne priporočamo (glejte poglavje 4.2).
• rash; redness of the skin,
• izpuščaj, rdečina kože
No evidence of saturation of bone uptake was found after chronic dosing with cumulative intravenous doses up to 35 mg/kg in animals.
Po kroničnem odmerjanju kumulativnih intravenskih odmerkov do 35 mg/kg pri živalih niso našli nobenih dokazov o nasičenju privzema v kosti.
Marketing Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Merck Sharp & Dohme B.V.
Excipients with known effect Each tablet contains 63 mg lactose (as lactose anhydrous) and 16 mg sucrose.
Pomožne snovi z znanim učinkom Ena tableta vsebuje 63 mg laktoze (v obliki brezvodne laktoze) in 16 mg saharoze.
Bioavailability was negligible whether alendronate was administered with, or up to two hours after, a standardised breakfast.
Pri jemanju alendronata skupaj s standardiziranim zajtrkom ali do dve uri po njem je bila biološka uporabnost zanemarljiva.
Osteoporosis is a thinning and weakening of the bones.
Osteoporoza je bolezen, zaradi katere postanejo kosti tanjše in šibkejše.
Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting this medicinal product.
Pred začetkom jemanja tega zdravila je treba učinkovito zdraviti tudi ostale bolezni, ki vplivajo na presnovo mineralov (kot npr. pomanjkanje vitamina D in hipoparatiroidizem).
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.
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.
VANTAVO 70 mg 5600 IU
VANTAVO 70 mg 5600 i.e.
; atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
, atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice (za bisfosfonate značilen neželeni učinek)