FrancophonIA/ELRC3.0 huggingface dataset:
English: As there is a risk of worsening of the underlying disease, caution should be observed if alendronate is given to patients with active upper gastrointestinal tract problems, such as dysphagia, oesophageal disease, gastritis, duodenitis or ulcers, or in cases of recent (during the last year) severe gastrointestinal disease such as gastric ulcer, active gastrointestinal bleeding or surgery in the upper gastrointestinal tract other than pyloroplasty (see section 4.3).
Slovenian: Ker obstaja tveganje za poslabšanje obstoječe bolezni, je potrebna previdnost pri dajanju Alendronata HEXAL bolnikom z aktivnimi težavami zgornjega dela prebavil, kot so disfagija, bolezen požiralnika, gastritis, vnetje dvanajstnika ali razjede, ali v primeru hujše bolezni prebavil v zadnjem času (v zadnjem letu), kot so želodčna razjeda, aktivna krvavitev iz prebavil ali kirurški poseg v zgornjem delu prebavil razen piloroplastike (glejte poglavje 4.3).
English: Concentrations of active substance in plasma following therapeutic oral doses are too low for analytical detection (<5 ng/ml).
Slovenian: Plazemske koncentracije zdravilne učinkovine po peroralnih terapevtskih odmerkih so za analitsko določitev prenizke (<5 ng/ml).
English: Important information about some of the ingredients of Alendronate HEXAL Alendronate HEXAL contains lactose.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Alendronat HEXAL Alendronat HEXAL vsebuje laktozo.
English: If taken at the same time, it is likely that foods and drinks (including mineral water), calcium supplements, antacids and some oral medicines will affect the absorption of alendronate.
Slovenian: Ob hkratnem jemanju lahko hrana in pijača (vključno z mineralno vodo), dodatki kalcija, antacidi in nekatera peroralna zdravila vplivajo na absorpcijo alendronske kisline.
English: Treatment of osteoporosis in men at increased risk of fracture.
Slovenian: Zdravljenje osteoporoze pri moških s povečanim tveganjem za zlom.
English: There are insufficient data regarding the use of alendronate in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi Alendronata HEXAL pri nosečnicah.
English: Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Slovenian: O osteonekrozi čeljusti, ki je običajno povezana s puljenjem zoba in/ali lokalno okužbo (vključno z osteomielitisom), so poročali pri bolnikih z rakom, katerih zdravljenje je vključevalo predvsem intravensko aplicirane difosfonate.
English: Take special care with Alendronate HEXAL Tell your doctor - if you suffer from kidney problems - if you have any swallowing or digestive problems - if you have low blood calcium levels.
Slovenian: Bodite posebno pozorni pri jemanju zdravila Alendronat HEXAL Zdravniku povejte - če imate težave z ledvicami, - če imate kakšne težave pri požiranju ali s prebavo, - če imate nizke vrednosti kalcija v krvi.
English: 5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate HEXAL and contact your doctor.
Slovenian: 5) Če se pojavijo težave ali bolečine pri požiranju, bolečine v prsih ali zgaga oz. stopnjevanje težav z zgago, prenehajte jemati zdravilo Alendronat HEXAL in se posvetujte z zdravnikom.
English: Preclinical studies have demonstrated a preference for localisation of alendronate to sites where active resorption takes place.
Slovenian: Predklinične študije so pokazale, da se alendronska kislina lokalizira predvsem v predelih, kjer poteka aktivna resorpcija.
English: The increases in BMD with alendronate 10 mg once daily were the same as for alendronate 5 mg once daily in all patients, with the exception of postmenopausal women who were not being treated with oestrogen.
Slovenian: Zvišanja MGK pri jemanju Alendronata HEXAL 10 mg enkrat dnevno so bila enaka kot pri jemanju Alendronata HEXAL 5 mg enkrat dnevno pri vseh bolnikih, z izjemo žensk po menopavzi, ki se niso zdravile z estrogenom.
English: Osteoporosis is defined as bone mineral density (BMD) of the spine or hip 2.5 standard deviations below the mean value of a normal young population or as a previous fragility fracture, irrespective of bone mineral density.
Slovenian: Osteoporoza je opredeljena kot mineralna gostota kosti (MGK) hrbtenice ali kolkov za 2,5 standardne deviacije pod povprečno vrednostjo, ki velja za normalno mlado populacijo, ali kot predhoden primer zloma zaradi krhkosti, do katerega pride ne glede na mineralno gostoto kosti.
English: A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated.
Slovenian: Dokazano je zmanjšanje pojavnosti vretenčnih, ne pa tudi nevretenčnih zlomov.
English: After two years of treatment with alendronate 10 mg/day, BMD increased on average by 5.3 % in the spine, by 2.6 % in the femoral neck, by 3.1 % in the trochanter, and by 1.6 % for the skeleton as a whole, relative to placebo (p<0.001 for all measurement points).
Slovenian: Po dveh letih zdravljenja z Alendronatom HEXAL 10 mg/dan, se je MGK v povprečju zvečala za 5,3% v hrbtenici, za 2,6% v vratu stegnenice, za 3,1% v trohantru in za 1,6% v okostju celotnega telesa, v primerjavi s placebom (p < 0,001 za vse točke merjenja).
English: To assist delivery to the stomach and thus reduce the risk of irritation/side effects locally and in the oesophagus (see section 4.4)
Slovenian: Za hiter prehod v želodec in zmanjšanje tveganja za draženje/neželene učinke lokalno in v požiralniku (glejte poglavje 4.4)
English: Consult your doctor before you begin any exercise programme.
Slovenian: Preden začnete s programom vadbe, se posvetujte s svojim zdravnikom.
English: If you miss a dose, just take one tablet on the morning after you remember.
Slovenian: Če ste pozabili vzeti zdravilo Alendronat HEXAL Če pozabite vzeti odmerek, vzemite eno tableto naslednje jutro, potem ko se spomnite.
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Slovenian: Bolnikom, pri katerih se med zdravljenjem z difosfonati razvije osteonekroza čeljusti, se lahko zaradi kirurškega posega na zobeh stanje poslabša.
English: Tablets
Slovenian: Tableta
English: Rare (≥1/10,000, <1/1000): Hypersensitivity reactions including urticaria and angioedema.
Slovenian: Redki (≥1/10.000, <1/1.000): preobčutljivostne reakcije, vključno z urtikarijo in angioedemom.
English: White to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "Arrow logo" on the other.
Slovenian: Tableta v obliki kapsule, bele ali skoraj bele barve, ki ima na eni strani vtisnjeno oznako "AN 10", na drugi strani pa "Arrow logo".
English: What Alendronate HEXAL looks like and contents of the pack Alendronate HEXAL are available as white to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "Arrow logo" on the other.
Slovenian: Izgled zdravila Alendronat HEXAL in vsebina pakiranja Alendronat HEXAL je na voljo kot tableta v obliki kapsule, bele do skoraj bele barve, ki ima na eni strani vtisnjeno oznako "AN 10", na drugi strani pa "Arrow logo".
English: Alendronate given to pregnant rats caused hypocalcaemia-related dystocia (see section 5.3).
Slovenian: Pri brejih podganah, ki so prejemale Alendronat HEXAL, je le-ta povzročil distocijo, povezano s hipokalcemijo (glejte poglavje 5.3).
English: Alendronate HEXAL has been shown to reduce the risk of spine and hip fractures in women and spine fractures in men.
Slovenian: Izkazalo se je, da Alendronat HEXAL zmanjša tveganje za zlome hrbtenice in kolka pri ženskah in zlome hrbtenice pri moških.
English: Causes of osteoporosis other than oestrogen deficiency, ageing and glucocorticoid use should be considered.
Slovenian: Poleg pomanjkanja estrogena, staranja in uporabe glukokortikoidov je treba preučiti tudi druge vzroke za osteoporozo.
English: Use in impaired hepatic function No dose adjustment is necessary.
Slovenian: Uporaba pri bolnikih z motnjami v delovanju jeter Prilagajanje odmerka ni potrebno.
English: In the patients treated with alendronate, the proportion of patients who suffered one or more vertebral fractures was reduced by 48 % (alendronate 3.2 % versus placebo 6.2 %).
Slovenian: Delež bolnic, ki so se zdravile z Alendronatom HEXAL in so imele enega ali več zlomov vretenc, se je znižal za 48% (Alendronat HEXAL 3,2% v primerjavi s placebom 6,2%).
English: In addition, other amendments to the Summary of Product Characteristics, labelling and package leaflet not in relation with the outcome of the referral procedure were included in accordance with the Guideline on Summary of Product Characteristics, excipient guideline and the latest Quality Review of Document templates.
Slovenian: Poleg tega so bila v skladu s smernicami o povzetku glavnih značilnosti, o pomožnih snoveh in zadnjimi predlogami za pregledovanje kakovosti dokumentov, vključena tudi druga dopolnila Povzetka glavnih značilnosti zdravila, označevanja in Navodila za uporabo, ki niso povezana z rezultatom napotitvenega postopka.
English: In addition, alendronate 10 mg and alendronate 5 mg were effective irrespective of age (<65 years as against ≥65 years), gender, baseline BMD, baseline bone turnover and concomitant use of a number of common medicines.
Slovenian: Poleg tega sta bila Alendronat HEXAL 10 mg in Alendronat HEXAL 5 mg učinkovita ne glede na starost (<65 let v primerjavi z ≥65 let), spol, MGK na začetku študije, kostno presnovo na začetku študije in sočasno uporabo številnih pogosto uporabljanih zdravil.
English: These side effects may worsen if patients continue to take Alendronate HEXAL after developing these symptoms.
Slovenian: Ti neželeni učinki se lahko stopnjujejo, če bolnik nadaljuje z jemanjem zdravila Alendronat HEXAL potem, ko so se simptomi že pojavili.
English: dizziness swelling in the hands or legs lack or loss of strength osteonecrosis (death of bone tissue)
Slovenian: omotica otekanje rok in nog pomanjkanje ali izguba moči ostenekroza (odmrtje kostnega tkiva) otekanje sklepov
English: Laboratory values: In clinical trials, asymptomatic, slight and transient decreases in serum calcium and serum phosphate were observed in approx. 18 and 10 % respectively of the patients taking alendronate 10 mg/day versus 12 and 3 % respectively of those taking placebo.
Slovenian: Izvidi laboratorijskih preiskav: V kliničnih preskušanjih so opazili asimptomatska, blaga in prehodna znižanja serumskega kalcija pri približno 18% bolnikov in serumskega fosfata pri približno 10% bolnikov, ki so jemali Alendronat HEXAL 10 mg na dan, v primerjavi z znižanjem serumskega kalcija pri približno 12% bolnikov in serumskega fosfata pri 3% bolnikov, ki so jemali placebo.
English: Take one Alendronate 10 mg tablet once daily.
Slovenian: Vzemite eno tableto Alendronata HEXAL 10 mg enkrat na dan.
English: - the literature provided by the applicant provide evidence that 10 mg daily could increase bone mineral density both at vertebral as well as non vertebral level in men with primary osteoporosis, - an effect on non-vertebral fractures has nonetheless not been demonstrated in this population.
Slovenian: - literatura, ki jo je predložil vlagatelj, je pokazala, da lahko 10 mg alendronata dnevno poveča mineralno gostoto kosti v vetrebralnem kot tudi v nevertebralnem okostju moških s primarno osteoporozo, - učinek na nevertebralne zlome kosti v tej populaciji kljub vsemu ni bil dokazan,
English: In these women the increases (relative to placebo) with alendronate 10 mg once daily were greater than for alendronate 5 mg once daily in the spine (4.11 % versus 1.56 %) and trochanter (2.84 % versus 1.67 %).
Slovenian: Pri teh ženskah so bila zvečanja (v primerjavi s placebom) pri zdravljenju z Alendronatom HEXAL 10 mg enkrat dnevno večja kot pri zdravljenju z Alendronatom HEXAL 5 mg enkrat dnevno v hrbtenici (4,11% v primerjavi z 1,56%) in trohantru (2,84% v primerjavi z 1,67%).
English: • Patients should not lie down within 30 minutes of taking Alendronate HEXAL tablets.
Slovenian: • Bolnik ne sme leči prej kot 30 minut po zaužitju Alendronat HEXAL tablet.
English: Eye disorders: Rare (≥1/10,000, <1/1000): Uveitis, scleritis, episcleritis
Slovenian: Očesne bolezni: Redki (≥1/10.000, <1/1.000): uveitis, skleritis, episkleritis
English: Very rare, not known: perforation of the oesophagus was reported in isolated cases
Slovenian: Zelo redki, ni znano: v posameznih primerih so poročali o perforaciji požiralnika
English: 10 mg per tablet
Slovenian: Peroralna uporaba 10 mg na tableto
English: Do not lie down within 30 minutes of taking Alendronat HEXAL
Slovenian: Ne ulezite se prej kot 30 minut po zaužitju tablete Alendronat HEXAL!
English: Patients should be informed that the risk of oesophageal problems may increase if they do not follow these instructions.
Slovenian: Bolnikom je treba povedati, da neupoštevanje teh navodil lahko poveča tveganje za težave s požiralnikom.
English: During post-marketing experience the following side effects have been reported (frequency unknown):
Slovenian: Po izdaji zdravila v promet so poročali o naslednjih neželenih učinkih (pogostnost ni znana):
English: The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans.
Slovenian: Srednja vrednost volumna porazdelitve v stanju dinamičnega ravnovesja (brez kosti) je pri ljudeh najmanj 28 litrov.
English: The fracture-preventing effect of increasing bone density with alendronate 10 mg or alendronate 5 mg in corticosteroidinduced osteoporosis has not been established.
Slovenian: Učinek preprečevanja zlomov zaradi zvečanja kostne gostote z Alendronatom HEXAL 10 mg ali Alendronatom HEXAL 5 mg pri osteoporozi, povzročeni s kortikosteroidi, ni bi ugotovljen.
English: There is no specific information available with regard to overdosage with alendronate.
Slovenian: Posebne informacije v zvezi s prevelikim odmerjanjem Alendronata HEXAL niso na voljo.
English: General disorders and administration site conditions: asthenia, peripheral oedema
Slovenian: Splošne težave in spremembe na mestu aplikacije: astenija, periferni edem
English: Therefore, somewhat greater accumulation of alendronate in bone might be expected in patients with impaired renal function (see section 4.2).
Slovenian: Zato se pri bolnikih z motnjami v delovanju ledvic lahko pričakuje nekoliko večje kopičenje alendronske kisline v kosteh (glejte poglavje 4.2).
English: Symptomatic hypocalcaemia, generally in connection with predisposing conditions (see.
Slovenian: Simptomatska hipokalcemija, običajno povezana s predispozicijami (glejte poglavje 4.4).
English: Nervous system disorders: dizziness
Slovenian: Bolezni živčevja: omotica
English: Alendronate HEXAL is effective only if taken when your stomach is empty.
Slovenian: Alendronat HEXAL je učinkovit samo, če ga vzamete na tešče.
English: Nervous system disorders: Common (≥1/100, <1/10): Headache
Slovenian: Bolezni živčevja: Pogosti (≥1/100, <1/10): glavobol
English: Alendronate is not recommended for patients with impaired renal function if the GFR is less than 35 ml/min (see section 4.2).
Slovenian: Zdravilo Alendronat HEXAL se ne priporoča bolnikom z motnjami v delovanju ledvic, pri katerih je hitrost glomerulne filtracije manjša od 35 ml/min (glejte poglavje 4.2).
English: Very common: ≥ 1/10
Slovenian: Zelo pogosti (≥1/10)
English: Post-menopausal osteoporosis:
Slovenian: Pomenopavzna osteoporoza:
English: In the initial efficacy studies, the increases in BMD with alendronate 10 mg daily relative to placebo after three years were 8.8 %, 5.9 % and 7.8 % at the spine, femoral neck and trochanter respectively.
Slovenian: V začetnih študijah učinkovitosti se je pri jemanju Alendronata HEXAL 10 mg dnevno v primerjavi s placebom po treh letih MGK hrbtenice zvišala za 8,8%, MGK vratu stegnenice za 5,9% in MGK trohantra za 7,8%.
English: Bioavailability decreased to an estimated 0.46 % and 0.39 % when alendronate was given an hour or half an hour before a standardised breakfast.
Slovenian: Biološka uporabnost se je pri zaužitju Alendronata HEXAL eno uro ali pol ure pred standardiziranim zajtrkom zmanjšala na ocenjenih 0,46% in 0,39%.
English: The studies indicated that alendronate 10 mg daily could increase bone mineral density both at vertebral as well as non vertebral level in men with primary osteoporosis.
Slovenian: Raziskave so pokazale, da lahko 10 mg alendronata dnevno pri moških s primarno osteoporozo poveča mineralno gostoto kosti v vertebralnem in tudi v nevertebralnem okostju.
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}> <[To be completed nationally]>
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA {MM/LLLL} [Izpolni država članica]
English: Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
Slovenian: O osteonekrozi čeljusti so poročali tudi pri bolnikih z osteoporozo, ki so jemali peroralne difosfonate.
English: • Alendronate HEXAL tablets should not be taken at bedtime or before arising for the day.
Slovenian: • Bolnik Alendronat HEXAL tablet ne sme vzeti pred spanjem ali preden zjutraj vstane.
English: The following undesirable effects have also been reported in clinical trials and/or post marketing:
Slovenian: V kliničnih študijah in/ali po izdaji zdravila v promet so poročali tudi o naslednjih neželenih učinkih:
English: 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 Alendronate HEXAL.
Slovenian: Pojavijo se lahko draženje, vnetje ali razjeda požiralnika (cevi, ki povezuje usta z želodcem), pogosto z znaki bolečine v prsnem košu, zgage ali težkega oz. bolečega požiranja, še posebno, če bolnik po zaužitju zdravila Alendronat HEXAL ne popije polnega kozarca vode in/ali se uleže prej kot po 30 minutah po zaužitju zdravila.
English: Alendronate HEXAL must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medication of the day!
Slovenian: Tablete Alendronat HEXAL je treba vzeti na prazen želodec takoj po jutranjem vstajanju izključno z navadno vodo, najmanj 30 minut pred zaužitjem prve hrane, pijače ali drugih zdravil v tem dnevu!
English: It reduces the risk of spine and hip fractures.
Slovenian: Zmanjša tveganje za zlome hrbtenice in kolka.
English: How to store Alendronate HEXAL Further information
Slovenian: Shranjevanje zdravila Alendronat HEXAL Dodatne informacije
English: Common: headache abdominal pain uncomfortable feeling in the stomach or belching after eating constipation full or bloated feeling in the stomach diarrhoea flatulence 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 bone, muscle and/or joint pain
Slovenian: Pogosti: glavobol bolečina v trebuhu neprijeten občutek v želodcu ali riganje po jedi zaprtje občutek polnega ali napihnjenega želodca driska vetrovi zgaga težave pri požiranju bolečine pri požiranju razjede požiralnika (požiralnik je cev, ki povezuje usta z želodcem), ki lahko povzročijo bolečine v prsnem košu, zgago ali težko/boleče požiranje bolečine v kosteh, mišicah in/ali sklepih
English: Microcrystalline cellulose
Slovenian: Mikrokristalna celuloza
English: In view of the indication, alendronate should not be used during pregnancy.
Slovenian: Zato se Alendronata HEXAL med nosečnostjo ne sme uporabljati.
English: Skin rash with photosensitivity.
Slovenian: Kožni izpuščaj z občutljivostno reakcijo na svetlobo.
English: Milk or antacids should be given in order to bind alendronate.
Slovenian: Bolnik naj popije mleko ali vzame antacid, ki vežeta alendronsko kislino.
English: Relative to placebo, BMD increased significantly in the spine (2.41 %), femoral neck (2.19 %) and trochanter (1.65 %) in patients who were treated with alendronate 5 mg once daily.
Slovenian: Bolniki so prejemali dodatke kalcija in vitamina D. V primerjavi s placebom se je MGK pomembno zvišala v hrbtenici (2,41%), vratu stegnenice (2,19%) in trohantru (1,65%) pri bolnikih, ki so se zdravili z Alendronatom HEXAL 5 mg enkrat dnevno.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: INFORMATION IN BRAILLE Alendronate HEXAL [To be completed nationally]
Slovenian: PODATKI V BRAILLOVI PISAVI Alendronat HEXAL [Izpolni država članica]
English: No effect on nonvertebral fractures was seen.
Slovenian: Opazili niso nobenih učinkov na nevretenčne zlome.
English: The active substance in Alendronate HEXAL tablets, sodium alendronate trihydrate, is a bisphosphonate that inhibits osteoclastic bone resorption without any direct effect on bone formation.
Slovenian: Zdravilna učnikovina v Alendronat HEXAL tabletah, natrijev alendronat trihidrat, je difosfonat, ki zavira osteoklastno kostno resorpcijo brez neposrednega učinka na tvorbo kosti.
English: “How to take Alendronate HEXAL”.
Slovenian: “Kako jemati zdravilo Alendronat HEXAL”.
English: • Alendronate HEXAL tablets should only be swallowed on rising for the day with a whole glass of water (not less than 200 ml or 7 fl. oz).
Slovenian: • Alendronat HEXAL tablete mora bolnik pogoltniti po jutranjem vstajanju s polnim kozarcem vode (ne manj kot 200 ml).
English: Other disorders of mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting alendronate.
Slovenian: Pred začetkom jemanja Alendronata HEXAL je treba učinkovito zdraviti tudi ostale motnje, ki vplivajo na presnovo mineralov (kot sta pomanjkanje vitamina D in hipoparatiroidizem).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg alendronic acid (as sodium alendronate trihydrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 10 mg alendronske kisline (v obliki natrijevega alendronata trihidrata).
English: Alendronate reduces the risk of vertebral and hip fractures.
Slovenian: Alendronat Hexal zmanjša tveganje za zlome vretenc in kolka.
English: The active substance is alendronate sodium trihydrate.
Slovenian: Zdravilna učinkovina je natrijev alendronat trihidrat.
English: The effect of alendronate on BMD was independent of age, race, gonadal function, baseline BMD or baseline bone turnover.
Slovenian: Učinek Alendronata HEXAL na MGK je bil neodvisen od starosti, rase, delovanja spolnih žlez, MGK na začetku študije ali kostne presnove na začetku študije.
English: Common (≥1/100, <1/10): Musculoskeletal pain (bones, muscles or joints) Rare (≥1/10,000, <1/1000): Severe musculoskeletal (bone, muscle or joint pain) (see section 4.4) Unknown frequency: Osteonecrosis
Slovenian: Pogosti (≥1/100, <1/10): mišično-skeletne bolečine (v kosteh, mišicah ali sklepih) Redki (≥1/10.000, <1/1.000): hude mišično-skeletne bolečine (bolečine v kosteh, mišicah ali sklepih) (glejte poglavje 4.4)
English: Each tablet contains 10 mg alendronic acid as alendronate sodium trihydrate.
Slovenian: Vsaka tableta vsebuje 10 mg alendronske kisline v obliki natrijevega alendronata trihidrata.
English: Alendronate HEXAL and associated names (see Annex I) 10 mg tablets [See Annex I - To be completed nationally]
Slovenian: Alendronat HEXAL in pripadajoča imena (glejte Dodatek I) 10 mg tablete [Glejte Dodatek I - Izpolni država članica]
English: Treatment of post-menopausal osteoporosis
Slovenian: Zdravljenje pomenopavzne osteoporoze