FrancophonIA/ELRC3.0 huggingface dataset:
English: It is very important that complete administration instructions are given to, and understood, by the patient (see section 4.2).
Slovenian: Zelo pomembno je, da se bolnika v celoti pouči o uporabi zdravila in da navodila tudi razume (glejte poglavje 4.2).
English: Eating a balanced diet Your doctor can advise you about your diet or whether you should take any dietary supplements.
Slovenian: Uravnotežena prehrana Zdravnik vam lahko svetuje glede prehrane ali morebitnih prehranskih dodatkov.
English: Bone formed during treatment with alendronate is of normal quality.
Slovenian: Kost, ki se tvori med zdravljenjem z Alendronatom HEXAL, je normalne kakovosti.
English: Bioavailability was negligible irrespective of whether alendronate was given together with or up to two hours after a standardised breakfast.
Slovenian: Biološka uporabnost je bila zanemarljiva ne glede na to, ali je bil Alendronat HEXAL vzet skupaj s standardiziranim zajtrkom ali do dve uri po njem.
English: If left untreated, however, it can result in broken bones.
Slovenian: Če se ne zdravi, lahko povzroči zlome kosti.
English: In the patients who received alendronate in doses up to 10 mg daily and in whom biopsy was performed after one year no signs of a disturbance of the bone mineralisation process were seen.
Slovenian: Pri bolnikih, ki so prejemali Alendronat HEXAL v odmerkih do 10 mg dnevno in pri katerih je bila po enem letu opravljena biopsija, niso opazili znakov motenj v procesu mineralizacije kosti.
English: Alendronate prevents the loss of bone, and helps to rebuild bone.
Slovenian: Alendronat HEXAL preprečuje izgubo kostne mase in pomaga pri ponovni gradnji kosti.
English: Three-year studies Alendronate10 mg daily (n=196)
Slovenian: Triletne študije Alendronat HEXAL 10 mg dnevno (n=196)
English: Most patients had relief of symptoms after stopping treatment.
Slovenian: Večina bolnikov je po prenehanju zdravljenja občutila olajšanje simptomov.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Despite no increased risk having been observed in extensive clinical trials, following marketing of the original preparation there have been reports of rare cases of gastric and duodenal ulcers, some of them severe and with complications.
Slovenian: Kljub temu, da v obsežnih kliničnih preskušanjih niso opazili povečanega tveganja, so po izdaji originatorjevega zdravila v promet poročali o redkih primerih razjed na želodcu in dvanajstniku, od katerih so bili nekateri hudi in s komplikacijami.
English: Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approx. 60 %.
Slovenian: Sočasna uporaba Alendronata HEXAL s kavo ali pomarančnim sokom je zmanjšala biološko uporabnost za približno 60%.
English: Lactose monohydrate
Slovenian: Laktoza monohidrat
English: Driving and using machines Alendronate HEXAL should not affect your ability to drive or operate machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Alendronat HEXAL ne bi smel vplivati na vašo sposobnost vožnje ali upravljanja strojev.
English: However, in rare cases, symptomatic hypocalcaemia has been reported which occasionally has been severe and often occurred in patients with predisposing conditions (e.g. hypoparathyroidism, vitamin D deficiency and in cases of calcium malabsorption).
Slovenian: Vendar pa obstajajo redka poročila o simptomatski hipokalcemiji, ki je bila občasno huda in se je pogosto pojavila pri bolnikih s predispozicijami (npr. hipoparatiroidizem, pomanjkanje vitamina D in v primerih malabsorpcije kalcija).
English: Animal studies revealed effects on foetal bone formation at high doses.
Slovenian: Študije na živalih so pokazale učinke na tvorbo kosti pri plodu pri visokih odmerkih.
English: Other drinks (including mineral water), food and some medicines are likely to reduce the absorption of alendronate (see section 4.5).
Slovenian: Druge pijače (vključno z mineralno vodo), hrana in nekatera zdravila lahko zmanjšajo absorpcijo Alendronata HEXAL (glejte poglavje 4.5).
English: It is not known whether alendronate is excreted into breast milk in humans.
Slovenian: Ni znano, ali se pri ljudeh alendronska kislina izloča v materino mleko.
English: Hypocalcaemia must be corrected before treatment with alendronate is initiated (see section 4.3).
Slovenian: Hipokalcemijo je treba korigirati pred začetkom zdravljenja z Alendronatom HEXAL (glejte poglavje 4.3).
English: Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.
Slovenian: Prenehanje kajenja Kaže, da kajenje povečuje hitrost izgubljanja kostne mase in lahko zato zveča tveganje za zlome kosti.
English: No undesirable effects could be related to the combination treatment.
Slovenian: S kombiniranim zdravljenjem ni bilo mogoče povezati nobenih neželenih učinkov.
English: • Patients should not lie down until after the first meal of the day, which must be at least 30 minutes after taking the tablet.
Slovenian: • Bolnik ne sme leči, dokler ne zaužije prvega dnevnega obroka, kar pa ne sme biti prej kot 30 minut po zaužitju tablete.
English: Adverse reactions reported by the investigators as possibly, probably or definitely related to the active substance are presented below if they occurred in ≥ 1 % of any in the treatment groups in the one-year study or in ≥ 1 % of the patients who were treated with alendronate 10 mg per day and with an incidence higher than in patients who were treated with placebo in three-year studies.
Slovenian: Neželene reakcije, o katerih so raziskovalci poročali, da so morda, verjetno ali zagotovo povezane z zdravilno učinkovino, so predstavljene spodaj, če so se pojavile pri ≥1% v katerikoli od skupin zdravljenja v enoletni študiji ali pri ≥1% bolnikov, ki so se zdravili z Alendronatom HEXAL 10 mg dnevno in pri katerih je bila pogostnost višja kot pri bolnikih, zdravljenih s placebom v triletnih študijah.
English: Therefore no adjustment of the dose is necessary for elderly patients.
Slovenian: Zato pri starejših prilagajanje odmerka ni potrebno.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/PE/PVDC/AL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU PVC/PE/PVDC/AL
English: A subset had recurrence of symptoms when rechallenged with the same medicinal product or another bisphosphonate.
Slovenian: Pri podskupini bolnikov so se simptomi ponovili, ko so ponovno prejeli enako zdravilo ali drug difosfonat.
English: 1) After getting up for the day and before taking any food, drink, or other medicine, swallow your Alendronate HEXAL with a full glass of water only (not mineral water) (not less than 200 ml or 7 fl. oz.).
Slovenian: 1) Ko zjutraj vstanete in še preden zaužijete kakršnokoli hrano, pijačo ali drugo zdravilo, pogoltnite tableto Alendronat HEXAL izključno s polnim kozarcem vode (ne mineralne vode) (ne manj kot 200 ml).
English: Transient symptoms as in an acute phase reaction (myalgia, malaise and in rare cases fever) usually in connection with the start of treatment.
Slovenian: Prehodni simptomi kot pri reakciji v akutni fazi (mialgija, slabo počutje in v redkih primerih zvišana telesna temperatura), običajno povezani z začetkom zdravljenja.
English: An effect on nonvertebral fractures has nonetheless not been demonstrated in this population.
Slovenian: Učinek zdravila na nevertebralne zlome pa v tej populaciji kljub vsemu ni bil dokazan.
English: Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Slovenian: Lečeči zdravnik bi moral po klinični presoji na podlagi razmerja med koristjo in tveganjem načrtovati obravnavo vsakega bolnika.
English: • FIT 1: A three-year study with 2027 patients who had had at least one baseline vertebral (compression) fracture.
Slovenian: • FIT 1: Triletna študija na 2027 bolnicah, ki so imele na začetku študije vsaj en (kompresijski) zlom vretenca.
English: A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated.”
Slovenian: Dokazano je bilo zmanjšanje pojavnosti vertebralnih zlomov, ne pa tudi nevertebralnih zlomov."
English: • Oesophageal abnormalities and other factors that delay oesophageal emptying, such as stricture or achalasia.
Slovenian: • Nenormalnosti požiralnika in drugi dejavniki, ki upočasnjujejo praznjenje požiralnika, kot sta zožitev ali ahalazija.
English: The applicant was asked to further justify the broad indication “treatment of osteoporosis in men” for Alendronate HEXAL.
Slovenian: Vlagatelj je bil zaprošen, da podrobneje utemelji široko zastavljeno indikacijo "zdravljenje osteoporoze pri moških" z zdravilom Alendronate HEXAL.
English: In a retrospective analysis (assessed by quantitative radiography) one new fracture (0.8 %) was documented among patients treated with alendronate, compared with 6 new fractures (7.1 %) for placebo (p=0.017).
Slovenian: Z retrospektivno analizo (ocenjeno s kvantitativno radiografijo) je bil dokumentiran en nov zlom (0,8%) med bolniki, ki so se zdravili z Alendronatom HEXAL, v primerjavi s 6 novimi zlomi (7,1%) pri placebu (p=0,017).
English: WHAT IS ALENDRONATE HEXAL AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO ALENDRONAT HEXAL IN ZA KAJ GA UPORABLJAMO
English: Alendronate has no influence on the ability to drive and use machines.
Slovenian: Alendronat HEXAL nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: Alendronate is not excreted through the acidic or basic transport systems of the kidney in rats, and thus it is not thought to interfere with the excretion of other active substances by those systems in humans.
Slovenian: Alendronska kislina se pri podganah ne izloča prek acidobaznega transportnega sistema ledvic in naj zato pri ljudeh ne bi ovirala izločanja drugih zdravilnih učinkovin prek teh sistemov.
English: Preclinical studies show that the active substance that is not deposited in bone is rapidly excreted in the urine.
Slovenian: Predklinične študije kažejo, da se zdravilna učinkovina, ki se ne nalaga v kosteh, hitro izloča z urinom.
English: For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Slovenian: Za bolnike, ki potrebujejo posege na zobeh, ni na voljo podatkov o tem, ali prenehanje zdravljenja z difosfonati zmanjša tveganje za osteonekrozo čeljusti.
English: Two studies from Orwell and Ringe demonstrated that compared respectively with placebo or alfacalcidol, alendronate treatment reduced the incidence of vertebral fractures in men with osteoporosis.
Slovenian: Dve raziskavi, ki sta jih izvedla Orwell in Ringe, sta pokazali, da zdravljenje z alendronatom v primerjavi s placebom ali alfakalcidolom zniža pojavnost vertebralnih zlomov pri moških z osteoporozo.
English: On account of the positive effects of alendronate on the increase in bone mineralisation, reductions in serum calcium and serum phosphate may occur.
Slovenian: Ker ima Alendronat HEXAL pozitivne učinke na povečanje vsebnosti mineralov v kosteh, se lahko pojavijo znižanja serumskega kalcija in fosfata.
English: Following a single intravenous dose of (14C) alendronate, approximately 50% of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the faeces.
Slovenian: Po enkratnem intravenskem odmerku (14C) Alendronata HEXAL se je približno 50% radioaktivnosti izločilo z urinom v 72 urah in v blatu so odkrili malo ali nič radioaktivnosti.
English: Alendronate HEXAL can treat your osteoporosis only if you continue to take the tablets.
Slovenian: Alendronat HEXAL lahko zdravi osteoporozo le, če redno jemljete tablete.
English: 7) It is important that you continue taking Alendronate HEXAL for as long as your doctor prescribes the medicine.
Slovenian: 7) Pomembno, je, da zdravilo Alendronat HEXAL jemljete tako dolgo, kot vam je predpisal zdravnik.
English: Osteoporosis in men: The recommended dosage is 10 mg once daily.
Slovenian: Osteoporoza pri moških: Priporočen odmerek je 10 mg enkrat dnevno.
English: Osteoporosis in men with increased risk of fracture The efficacy of alendronate 10 mg once daily in men (31-87 years, mean age 63 years, n=241) with osteoporosis was evaluated in a two-year study.
Slovenian: Osteoporoza pri moških s povečanim tveganjem za zlom Učinkovitost Alendronata HEXAL 10 mg enkrat dnevno pri moških (starih 31-87 let, povprečna starost 63 let, n=241) z osteoporozo so ocenjevali v dvoletni študiji.
English: 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.
Slovenian: Največkrat se zlomijo kosti kolka, hrbtenice ali zapestja, ki ne povzročajo samo bolečin, temveč tudi precejšnje težave, kot so sključena drža (grba) in nezmožnost gibanja.
English: Your doctor has prescribed Alendronate HEXAL to treat your osteoporosis.
Slovenian: Zdravnik vam je predpisal Alendronat HEXAL za zdravljenje osteoporoze.
English: In healthy persons, oral prednisolone (20 mg three times daily for five days) did not result in any clinically meaningful change in the oral bioavailability of alendronate (a mean increase ranging from 20 % to 44 %).
Slovenian: Pri zdravih osebah peroralno jemanje prednizolona (20 mg trikrat dnevno pet dni) ni povzročilo nobene klinično pomembne spremembe biološke uporabnosti Alendronata HEXAL (srednje zvišanje se je gibalo od 20% do
English: “Treatment of osteoporosis in men at increased risk of fracture.
Slovenian: "Zdravljenje osteoporoze pri moških s povečanim tveganjem za zlom.
English: During post-marketing experience the following reactions have been reported (frequency unknown):
Slovenian: Po izdaji zdravila v promet so poročali o naslednjih reakcijah (pogostnost ni znana):
English: Osteoclastic activity is inhibited, but formation and binding of the osteoclasts is not affected.
Slovenian: Delovanje osteoklastov je zavrto, vendar pa njihova tvorba in vezava nista prizadeti.
English: Like all medicines, Alendronate HEXAL can have side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Alendronat HEXAL neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Alendronate HEXAL tablets contain lactose.
Slovenian: Alendronat HEXAL tablete vsebujejo laktozo.
English: In two three-year studies of almost identical design, with post-menopausal women (alendronate 10 mg: n=196; placebo: n=397) the overall safety profiles for alendronate 10 mg daily and placebo were similar.
Slovenian: V dveh skoraj enako zasnovanih triletnih študijah na pomenopavznih ženskah (Alendronat HEXAL 10 mg: n=196; placebo: n=397) sta bila skupna varnostna profila Alendronata HEXAL 10 mg dnevno in placeba podobna.
English: Studies in rats show that alendronate is initially distributed to soft tissues after intravenous administration of 1 mg/kg, but is then rapidly redistributed to the skeleton or excreted in the urine.
Slovenian: Študije pri podganah kažejo, da se alendronska kislina po intravenski aplikaciji 1 mg/kg najprej porazdeli v mehka tkiva, vendar se nato hitro prerazporedi v kosti ali se izloči z urinom.
English: Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
Slovenian: Dejavniki tveganja naj bi bili tudi diagnoza raka, kemoterapija, radioterapija, kortikosteroidi in slaba ustna higiena (glejte poglavje 4.4).
English: The tablets are supplied in triplex blister (PVC/PE/PVDC/AL) packaging.
Slovenian: Tablete so na voljo v pakiranju s tremi pretisnimi omoti (PVC/PE/PVDC/AL).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malapsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Studies in female rats showed that treatment with alendronate during pregnancy was associated with dystocia during parturition, which was related to hypocalcaemia.
Slovenian: Študije pri podganjih samicah so pokazale, da je zdravljenje z Alendronatom HEXAL med nosečnostjo povezano z distocijo med porodom, ki je bila povezana s hipokalcemijo.
English: 6) After swallowing your Alendronate HEXAL, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
Slovenian: 6) Ko pogoltnete tableto Alendronat HEXAL, počakajte vsaj 30 minut, preden zaužijete prvo hrano, pijačo ali drugo zdravilo v tem dnevu, vključno z antacidi, dodatki kalcija in vitamini.
English: Patients must therefore wait for at least 30 minutes after taking alendronate before taking any other oral medicine (see section 4.2).
Slovenian: Bolniki morajo zato po zaužitju Alendronata HEXAL počakati vsaj 30 minut, preden peroalno vzamejo katerokoli drugo zdravilo (glejte poglavje 4.2).
English: The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate.
Slovenian: Pomožne snovi so mikrokristalna celuloza, laktoza monohidrat, premrežen natrijev karmelozat, magnezijev stearat.
English: The CHMP has recommended the granting of the Marketing Authorisation and the amendment of the Summary of Product Characteristics, labelling, package leaflet of the Reference Member State accordingly for Alendronate HEXAL and associated names (see Annex I) 10 mg tablets.
Slovenian: CHMP je priporočil odobritev dovoljenja za promet in dopolnila Povzetka glavnih značilnosti zdravila, označevanja in Navodila za uporabo za referenčno državo članico za zdravilo Alendronate HEXAL 10 mg tablete in z njim povezana imena (glejte Dodatek I).
English: In osteoporosis studies alendronate was effective when it was given at least 30 minutes before the first meal or drink of the day.
Slovenian: V študijah osteoporoze je bil Alendronat HEXAL učinkovit pri jemanju vsaj 30 minut pred prvim dnevnim obrokom hrane ali pijače.
English: In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during treatment with alendronate.
Slovenian: Pri bolnikih s temi boleznimi je treba med zdravljenjem z Alendronatom HEXAL spremljati serumski kalcij in simptome hipokalcemije.
English: This medicinal product is authorised in the Member States of the EEA under the following names:>
Slovenian: Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: Švedska
English: The FIT study included two placebo-controlled trials in which alendronate was given daily (5 mg daily for two years and 10 mg daily for a further one or two years).
Slovenian: Študija FIT je vključevala dvoje s placebom nadzorovanih preskušanj, v katerih so bolnice jemale Alendronat HEXAL vsak dan (5 mg dnevno dve leti in 10 mg dnevno nadaljnje leto ali dve).
English: It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronate HEXAL if taken at the same time.
Slovenian: Verjetno je, da bodo dodatki kalcija, antacidi in nekatera peroralna zdravila motila absorpcijo Alendronata HEXAL, če jih boste vzeli istočasno.
English: In clinical trials there was no age-related difference with regard to efficacy or safety profiles of alendronate.
Slovenian: V kliničnih preskušanjih ni bilo nobene od starosti odvisne razlike v učinkovitosti ali varnosti Alendronata HEXAL.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <{DD/MM/YYYY}> <{DD month YYYY}> <[To be completed nationally]>
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET {DD/MM/LLLL} {DD mesec LLLL} [Izpolni država članica]
English: What is Alendronate HEXAL and what is it used for Before you take Alendronate HEXAL How to take Alendronate HEXAL Possible side effects
Slovenian: Kaj je zdravilo Alendronat HEXAL in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Alendronat HEXAL Kako jemati zdravilo Alendronat HEXAL Možni neželeni učinki
English: The reduction in height was less after treatment with alendronate, relative to placebo (-0.6 mm and -2.4 mm respectively, p=0.02).
Slovenian: Znižanje višine je bilo po zdravljenju z Alendronatom HEXAL manjše kot pri placebu (-0,6 mm v primerjavi z -2,4 mm, p=0,02).
English: The risk of severe oesophageal side effects is thought to be greater in patients who do not take alendronate correctly and/or continue to take alendronate after developing symptoms indicative of oesophageal irritation.
Slovenian: Kaže, da je tveganje za pojav hudih neželenih učinkov v požiralniku večje pri bolnikih, ki Alendronata HEXAL ne jemljejo pravilno in/ali nadaljujejo z jemanjem Alendronata HEXAL po pojavu simptomov, ki kažejo na draženje požiralnika.
English: In this study alendronate daily reduced the incidence of ≥1 new vertebral fracture by 47 % (alendronate 7.9 % versus placebo 15.0 %).
Slovenian: V tej študiji je dnevno jemanje Alendronata HEXAL zmanjšalo pojavnost ≥1 novega zloma vretenc za 47% (Alendronat HEXAL 7,9% v primerjavi s placebom 15,0%).
English: In this study, in a subgroup analysis of osteoporotic women (37 % of the total population who fulfilled the definition of osteoporosis given above) a significant difference was seen in the incidence of hip fractures (alendronate 1.0 % versus placebo 2.2 %, a reduction of 56 %) and in the incidence of ≥1 vertebral fracture (2.9 % versus 5.8 %, a reduction of 50 %).
Slovenian: V tej študiji so pri analizi podskupine žensk z osteoporozo (37% celotne populacije, ki je ustrezala zgoraj navedeni definiciji osteoporoze) opazili pomembno razliko v pojavnosti zlomov kolka (Alendronat HEXAL 1,0% v primerjavi s placebom 2,2%, zmanjšanje za 56%) in pojavnosti ≥1 zloma vretenc (2,9% v primerjavi z 5,8%, zmanjšanje za 50%).
English: 4) Do not take Alendronate HEXAL at bedtime or before getting up for the day.
Slovenian: 4) Zdravila Alendronat HEXAL ne vzemite zvečer ali preden zjutraj vstanete.
English: Compared with an intravenous reference dose, the mean oral bioavailability of alendronate in women was 0.64 % for doses ranging from 5 to 70 mg given after an overnight fast and two hours before a standardised breakfast.
Slovenian: V primerjavi z intravenskim referenčnim odmerkom je bila srednja peroralna biološka uporabnost Alendronata HEXAL pri ženskah 0,64% za odmerke med 5 do 70 mg, vzete zjutraj na tešče in dve uri pred standardiziranim zajtrkom.
English: Please store in the original package in order to protect from moisture.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA
English: • Alendronate HEXAL tablets should be swallowed whole.
Slovenian: • Alendronat HEXAL tablete je treba pogoltniti cele.
English: The efficacy of alendronate 10 mg and alendronate 5 mg once daily in men and women treated with steroids (at least 7.5 mg/day of prednisone or equivalent, median dose 10 mg/day) was demonstrated in two one-year studies of practically identical design.
Slovenian: Učinkovitost Alendronata HEXAL 10 mg in Alendronata HEXAL 5 mg enkrat dnevno pri moških in ženskah, ki se zdravijo s steroidi (najmanj 7,5 mg/dan prednizona ali ekvivalenta, povprečni odmerek 10 mg/dan), je bila dokazana v dveh skoraj enako zasnovanih enoletnih študijah.
English: A number of patients in the clinical trials received oestrogen (intravaginally, transdermally or orally) concomitantly with alendronate.
Slovenian: Številni bolniki so v kliničnih preskušanjih prejemali estrogen (intravaginalno, transdermalno ali peroralno) sočasno z Alendronatom HEXAL.