natgillin/translations-raw huggingface dataset:
Alendronate is not recommended for patients with impaired renal function if the GFR is less than 35 ml/ min, as there is no experience of this.
Bolnikom z motnjami v delovanju ledvic, pri katerih je hitrost glomerulne filtracije pod 35 ml/ min, se zdravilo Alendronat HEXAL zaradi pomanjkanja izkušenj ne priporoča.
Use in children Alendronate HEXAL is not recommended for use in children due to a lack of data on safety and efficacy.
Uporaba pri otrocih Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Alendronat HEXAL pri otrocih ni priporočljiva.
• Hypersensitivity to the active substance or to any of the excipients. • Oesophageal abnormalities and other factors that delay oesophageal emptying, such as stricture or achalasia. • Inability to stand or sit upright for at least 30 minutes. • Hypocalcaemia.
• Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov. • Nenormalnosti požiralnika in drugi dejavniki, ki upočasnjujejo praznjenje požiralnika, kot sta zožitev ali ahalazija. • Nesposobnost stati ali sedeti vzravnano vsaj 30 minut. • Hipokalcemija.
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).
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).
The patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new/ worsened heartburn.
Bolnike je treba poučiti, da v primeru pojava simptomov draženja požiralnika, kot so disfagija, bolečina pri požiranju, retrosternalna bolečina ali pojav oz. poslabšanje zgage, prekinejo jemanje Alendronata HEXAL in poiščejo zdravniško pomoč.
8 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.
8 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.
It is very important that complete administration instructions are given to, and understood, by the patient (see section 4.2).
Zelo pomembno je, da se bolnika v celoti pouči o uporabi zdravila in da navodila tudi razume (glejte poglavje 4. 2).
A causal relationship cannot be excluded (see section 4.8).
Vzročne povezave ni mogoče izključiti (glejte poglavje 4. 8).
Alendronate is not recommended for patients with impaired renal function if the GFR is less than 35 ml/ min (see section 4.2).
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).
Hypocalcaemia must be corrected before treatment with alendronate is initiated (see section 4.3).
Hipokalcemijo je treba korigirati pred začetkom zdravljenja z Alendronatom HEXAL (glejte poglavje 4. 3).
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).
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).
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.
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.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e. g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Pri bolnikih s sočasnimi dejavniki tveganja (npr. rak, kemoterapija, radioterapija, kortikosteroidi, slaba ustna higiena) je treba razmisliti o zobozdravstvenem pregledu pri ustreznem zobozdravniku.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Lečeči zdravnik bi moral po klinični presoji na podlagi razmerja med koristjo in tveganjem načrtovati obravnavo vsakega bolnika.
Bone, joint, and/ or muscle pain has been reported in patients taking bisphosphonates.
Pri bolnikih, ki so jemali difosfonate, so poročali o bolečinah v kosteh, sklepih in/ ali mišicah.
In post- marketing experience, these symptoms have rarely been seen and/ or incapacitating (see section 4.8).
Po izdaji zdravila v promet so te učinke redko opazili in/ ali so bili redko moteči (glejte poglavje 4. 8).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malapsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
9 4.5 Interaction with other medicinal products and other forms of interaction
9 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Patients must therefore wait for at least 30 minutes after taking alendronate before taking any other oral medicine (see section 4.2).
Bolniki morajo zato po zaužitju Alendronata HEXAL počakati vsaj 30 minut, preden peroalno vzamejo katerokoli drugo zdravilo (glejte poglavje 4. 2).
Alendronate given to pregnant rats caused hypocalcaemia-related dystocia (see section 5.3).
Pri brejih podganah, ki so prejemale Alendronat HEXAL, je le- ta povzročil distocijo, povezano s hipokalcemijo (glejte poglavje 5. 3).
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.
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.
Three-year studies Gastrointestinal
Triletne študije Prebavni
Alendronate10 mg daily (n=196)%
Alendronat HEXAL 10 dnevno (n=196)%
Abdominal pain Dyspepsia Acid regurgitation Nausea Abdominal distension Constipation Diarrhoea Dysphagia Flatulence
Bolečina v trebuhu Dispepsija Regurgitacija kisline Navzeja Napet trebuh Zaprtje Driska Disfagija Flatulenca Gastritis Želodčna razjeda
Alendronate10 mg daily (n=196)%
Alendronat HEXAL 10 mg dnevno (n=196)%
Gastritis Gastric ulcer Oesophageal ulcer Musculoskeletal
Razjeda požiralnika Mišično- skeletni
Musculoskeletal pain (bone, muscle or joints)
Bolečina v mišicah in kosteh (kosti, mišice ali sklepi)
Muscle cramps Neurological
Mišični krči Živčevje
The following undesirable effects have also been reported in clinical trials and/ or post marketing:
V kliničnih študijah in/ ali po izdaji zdravila v promet so poročali tudi o naslednjih neželenih učinkih:
Very common: ≥ 1/ 10 Common: ≥ 1/ 100 - < 1/ 10 Uncommon: ≥ 1/ 1,000 - < 1/ 100 Rare: ≥ 1/ 10,000 - < 1/ 1,000 Very rare: < 1/ 10,000, not known (cannot be estimated from the available data)
Zelo pogosti (≥1/ 10) Pogosti (≥1/ 100 do < 1/ 10) Občasni (≥1/ 1. 000 do < 1/ 100) Redki (≥1/ 10. 000 do < 1/ 1. 000) Zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Headache
Pogosti (≥1/ 100, < 1/ 10): glavobol
Uveitis, scleritis, episcleritis
Redki (≥1/ 10. 000, < 1/ 1. 000): uveitis, skleritis, episkleritis
Uncommon (≥ 1/ 1000, < 1/ 100):
Pogosti (≥1/ 100, < 1/ 10): bolečina v trebuhu, dispepsija, zaprtje, driska, flatulenca, razjede požiralnika *, disfagija *, napet trebuh, regurgitacija kisline.
Rare (≥ 1/ 10,000, < 1/ 1000):
Občasni (≥1/ 1. 000, < 1/ 100): navzeja, bruhanje, gastritis, ezofagitis *, erozije požiralnika *, melena.
*See section 4.2 and 4.4.
* Glejte poglavji 4. 2 in 4. 4.
Isolated cases of severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Zelo redki (≤1/ 10. 000): poročali so o posameznih primerih hudih kožnih reakcij, vključno s Stevens - Johnsonovim sindromom in toksično epidermalno nekrolizo.
Osteonecrosis
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) Pogostnost ni znana: osteonekroza
Uncommon (≥ 1/ 1000, < 1/ 100):
Občasni (≥1/ 1. 000, < 1/ 100): izpuščaj, srbenje, eritem.
Hypersensitivity reactions including urticaria and angioedema.
Redki (≥1/ 10. 000, < 1/ 1. 000): preobčutljivostne reakcije, vključno z urtikarijo in angioedemom.
Section 4.4).
Simptomatska hipokalcemija, običajno povezana s predispozicijami (glejte poglavje 4. 4).
11 During post-marketing experience the following reactions have been reported (frequency unknown):
11 Po izdaji zdravila v promet so poročali o naslednjih reakcijah (pogostnost ni znana):
Musculoskeletal and connective tissue disorders: Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Pri bolnikih, ki so se zdravili z difosfonati, so poročali o osteonekrozi čeljusti.
Osteonecrosis of the jaw is generally associated with tooth extraction and/ or local infection (including osteomyelistis).
Osteonekroza čeljusti se običajno povezuje s puljenjem zoba in/ ali lokalno okužbo (vključno z osteomielitisom).
Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4). joint swelling
Dejavniki tveganja naj bi bili tudi diagnoza raka, kemoterapija, radioterapija, kortikosteroidi in slaba ustna higiena (glejte poglavje 4. 4). otekanje sklepov
Laboratory values:
Izvidi laboratorijskih preiskav:
18 and 10% respectively of the patients taking alendronate 10 mg/ day versus 12 and 3% respectively of those taking placebo.
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.
However, the incidence of reductions in serum calcium to < 2.0 mmol/ l and serum phosphate to ≤ 0.65 mmol/ l was comparable in the two groups.
Vendar pa je bila pojavnost znižanja serumskega kalcija na < 2, 0 mmol/ l in serumskega fosfata na ≤ 0, 65 mmol/ l v obeh skupinah primerljiva.
Drugs for treatment of bone diseases, bisphosphonates.
Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati.
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.
Osteoporoza je opredeljena z zmanjšanjem mineralne gostote kosti (MGK) hrbtenice ali kolka za 2. 5 standardni deviaciji pod srednjo vrednost za normalno mlado populacijo ali s predhodnim zlomom krhkih kosti ne glede na MKG.
12 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.
12 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%.
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%).
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%).
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). • FIT 1:
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). • FIT 1:
A three-year study with 2027 patients who had had at least one baseline vertebral (compression) fracture.
Triletna študija na 2027 bolnicah, ki so imele na začetku študije vsaj en (kompresijski) zlom vretenca.
In this study alendronate daily reduced the incidence of ≥ 1 new vertebral fracture by 47% (alendronate 7.9% versus placebo 15.0%).
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%).
In addition, a statistically significant reduction in the incidence of hip fractures was confirmed (1.1% versus 2.2%, a reduction of 51%). • FIT 2:
Poleg tega je bilo potrjeno statistično pomembno zmanjšanje pojavnosti zlomov kolka (1, 1% v primerjavi z 2, 2%, zmanjšanje za 51%). • FIT 2:
A four-year study with 4432 patients who had a low bone mass but had not had any vertebral fracture at the start of the study.
Štiriletna študija na 4432 bolnicah z nizko kostno maso, vendar na začetku študije brez zloma vretenca.
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%).
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%).
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.
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.
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).
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).
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).
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).
The reduction in height was less after treatment with alendronate, relative to placebo (-0.6 mm and -2.4 mm respectively, p=0.02).
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).
No effect on non- vertebral fractures was seen.
Opazili niso nobenih učinkov na nevretenčne zlome.
Glucocorticoid-induced osteoporosis Long-term use of steroids is often associated with the development of osteoporosis accompanied by fractures.
Osteoporoza, povzročena z glukokortikoidi Dolgotrajna uporaba steroidov je pogosto povezana z razvojem osteoporoze, ki jo spremljajo zlomi.
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.
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.
These studies involved a total of 560 patients aged 17-83 years.
Ti študiji sta vključevali skupaj 560 bolnikov v starosti 17- 83 let.
The patients received calcium and vitamin D supplements.
Bolniki so prejemali dodatke kalcija in vitamina D.
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.
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.
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 post- menopausal women who were not being treated with oestrogen.
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.
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%).
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%).
The fracture-preventing effect of increasing bone density with alendronate 10 mg or alendronate 5 mg in corticosteroid- induced osteoporosis has not been established.
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.
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.
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.
In the patients who received alendronate in doses up to 10 mg daily and in whom
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.
Absorption 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.
Absorpcija 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.
Bioavailability decreased to an estimated 0.46% and 0.39% when alendronate was given an hour or half an hour before a standardised breakfast.
Biološka uporabnost se je pri zaužitju Alendronata HEXAL eno uro ali pol ure pred standardiziranim zajtrkom zmanjšala na ocenjenih 0, 46% in 0, 39%.
60%.
Sočasna uporaba Alendronata HEXAL s kavo ali pomarančnim sokom je zmanjšala biološko uporabnost za približno 60%.
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%).
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 44%).
Distribution 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.
Porazdelitev 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.
Concentrations of active substance in plasma following therapeutic oral doses are too low for analytical detection (< 5 ng/ ml).
Plazemske koncentracije zdravilne učinkovine po peroralnih terapevtskih odmerkih so za analitsko določitev prenizke (< 5 ng/ ml).
Elimination 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.
Izločanje 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.
Following a single intravenous dose of 10 mg, the renal clearance of alendronate was 71 ml/ min, and systemic clearance did not exceed 200 ml/ min.
Po enkratnem intravenskem odmerku 10 mg je bil ledvični očistek alendronske kisline 71 ml/ min, sistemski očistek pa ni presegel 200 ml/ min.
Characteristics in patients Preclinical studies show that the active substance that is not deposited in bone is rapidly excreted in the urine.
Značilnosti pri bolnikih Predklinične študije kažejo, da se zdravilna učinkovina, ki se ne nalaga v kosteh, hitro izloča z urinom.
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 motnjami v delovanju ledvic lahko pričakuje nekoliko večje kopičenje alendronske kisline v kosteh (glejte poglavje 4. 2).
Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate
Mikrokristalna celuloza Laktoza monohidrat Premrežen natrijev karmelozat Magnezijev stearat
The tablets are supplied in triplex blister (PVC/ PE/ PVDC/ AL) packaging.
Tablete so na voljo v pakiranju s tremi pretisnimi omoti (PVC/ PE/ PVDC/ AL).
< [See Annex I - To be completed nationally]
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