natgillin/translations-raw huggingface dataset:
Elderly patients (≥ 65 years) No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Starejši bolniki (≥ 65 let) Prilagajanje odmerjanja ni potrebno, ker so vrednosti biološke uporabnosti, porazdelitve in izločanja iz telesa pri starejših bolnikih in mlajših preiskovancih podobne.
Children and adolescents Aclasta is not recommended for use in children and adolescents below 18 years of age due to lack of data on safety and efficacy.
Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Aclasta pri otrocih in mladostnikih pod 18 let ni priporočljiva.
Hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov ali na katerega od difosfonatov.
Aclasta is contraindicated for patients with hypocalcaemia (see section 4.4).
Aclasta je kontraindicirana pri bolnikih s hipokalciemijo (glejte poglavje 4. 4).
Aclasta is contraindicated during pregnancy and in breast-feeding women (see section 4.6).
Aclasta je kontraindicirana med nosečnostjo in za doječe ženske (glejte poglavje 4. 6).
The dose of 5 mg zoledronic acid must be administered over at least 15 minutes.
Petmiligramski odmerek zoledronske kisline morate infundirati vsaj 15 minut.
Aclasta is not recommended in patients with severe renal impairment (creatinine clearance < 35 ml/ min) due to limited clinical experience in this population.
Zdravila Aclasta ne priporočajo za bolnike s hudo ledvično okvaro (očistek kreatinina < 35 ml/ min), zaradi omejenega obsega kliničnih izkušenj pri tej skupini bolnikov.
Patients should have their serum creatinine level measured before receiving Aclasta.
Bolnikom je treba izmeriti raven kreatinina v serumu, preden prejmejo zdravilo Aclasta.
Patients must be appropriately hydrated prior to administration of Aclasta.
Bolniki morajo biti pred uporabo zdravila Aclasta primerno hidrirani.
This is especially important in the elderly and for patients receiving diuretic therapy.
To je posebno pomembno za starejše in za bolnike, ki jemljejo diuretike.
Caution is indicated when Aclasta is administered in conjunction with medicinal products that can significantly impact renal function (e. g. aminoglycosides or diuretics that may cause dehydration), see section 4.5.
Previdnost je potrebna, kadar uporabljate zdravilo Aclasta skupaj z zdravili, ki lahko znatno vplivajo na delovanje ledvic (npr. z aminoglikozidi ali diuretiki, ki lahko povzročijo dehidracijo), glejte poglavje 4. 5.
Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Aclasta (see section 4.3).
Že obstoječo hipokalciemijo je treba zdraviti z zadostnim vnosom kalcija in vitamina D še pred uvedbo zdravljenja z zdravilom Aclasta (glejte poglavje 4. 3).
Other disturbances of mineral metabolism must also be effectively treated (e. g. diminished parathyroid reserve, intestinal calcium malabsorption).
Učinkovito je treba zdraviti tudi druge motnje presnove elektrolitov (kot sta zmanjšano delovanje ostanka obščitnice in okvarjena absorpcija kalcija v črevesju).
3 Elevated bone turnover is a characteristic of Paget’ s disease of the bone.
Povečana kostna presnova je značilnost Pagetove bolezni kosti.
Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of Aclasta (see section 4.8).
3 simptomatska in ki je navadno najbolj izražena v prvih 10 dneh po infuziji zdravila Aclasta (glejte poglavje 4. 8).
Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
Skupaj z dajanjem zdravila Aclasta priporočajo zadostno uživanje kalcija in vitamina D.
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration (see section 4.2).
Poleg tega je zelo priporočljivo, da bolnikom s Pagetovo boleznijo zagotovimo zadostno dodajanje kalcija, ki ustreza vsaj 500 mg elementarnega kalcija, dvakrat na dan vsaj 10 dni po uporabi zdravila Aclasta (glejte poglavje 4. 2).
Severe and occasionally incapacitating bone, joint and/ or muscle pain have been infrequently reported in patients taking bisphosphonates, including Aclasta.
Pri bolnikih, ki jemljejo difosfonate, vključno z zdravilom Aclasta, so redko poročali o hudih bolečinah v kosteh, sklepih in/ ali mišicah, ki so bolnike občasno onesposobile.
Aclasta contains the same active substance found in Zometa (zoledronic acid), used for oncology indications, and a patient being treated with Zometa should not be treated with Aclasta.
Bolniki, ki prejemajo zdravilo Zometa, ne smejo prejemati še zdravila Aclasta.
Osteonecrosis of the jaw (ONJ):
Osteonekroza čeljusti:
Osteonecrosis of the jaw has been reported predominantly in patients with cancer receiving treatment regimens including bisphosphonates, including zoledronic acid.
O osteonekrozi čeljusti so poročali predvsem pri bolnikih z rakom na terapevtskih shemah, ki vključujejo difosfonate, vključno z zoledronsko kislino.
Many of these patients were also receiving chemotherapy and corticosteroids.
Številni izmed teh bolnikov so dobivali tudi kemoterapijo in kortikosteroide.
The majority of reported cases have been associated with dental procedures such as tooth extraction.
Večina primerov, o katerih so poročali, je bila povezana z zobozdravstvenimi posegi, kot je ekstrakcija zoba.
Many had signs of local infection including osteomyelitis.
Številni izmed njih so imeli znake lokalne okužbe, vključno z osteomielitisom.
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, corticosteroids, poor oral hygiene).
Pri bolnikih s spremljajočimi dejavniki tveganja (na primer rak, kemoterapija, kortikosteroidi, slaba ustna higiena) je treba pred začetkom zdravljenja z difosfonati razmisliti o zobozdravniškem pregledu z ustreznimi preventivnimi zobozdravstvenimi ukrepi.
The clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Lečeči zdravnik naj se pri vodenju zdravljenja posameznega bolnika opira na klinično presojo na podlagi ocene individualnega razmerja med koristjo in tveganjem.
Specific drug-drug interaction studies have not been conducted with zoledronic acid.
Z zoledronsko kislino niso opravili posebnih študij o medsebojnem delovanju zdravil.
Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2).
Zoledronska kislina se sistemsko ne presnavlja ter in vitro ne vpliva na encime citokroma P450 pri človeku (glejte poglavje 5. 2).
Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound drugs are therefore unlikely.
Zoledronska kislina se ne veže v veliki meri na beljakovine plazme (vezana je približno v 43- 55%), zato interakcije, ki se kažejo kot izrinjanje zdravil pretežno vezanih na beljakovine, niso verjetne.
Zoledronic acid is eliminated by renal excretion.
Zoledronska kislina se odstranjuje iz telesa z izločanjem skozi ledvice.
Caution is indicated when Aclasta is administered in conjunction with medicinal products that can significantly impact renal function (e. g. aminoglycosides or diuretics that may cause dehydration).
Kadar uporabljamo zdravilo Aclasta skupaj z zdravili, ki lahko znatno vplivajo na delovanje ledvic (npr. z aminoglikozidi ali diuretiki, ki lahko povzročijo dehidracijo), je potrebna previdnost.
Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations (see section 5.3).
Študije z zoledronsko kislino pri živalih so pokazale vpliv na sposobnost razmnoževanja, med drugim tudi malformacije (glejte poglavje 5. 3).
It is not known whether zoledronic acid is excreted into human breast milk.
Prav tako ni znano, ali se zoledronska kislina izloča v materino mleko pri ljudeh.
Aclasta is contraindicated during pregnancy and in breast-feeding women (see section 4.3).
Aclasta je kontraindicirana med nosečnostjo in za doječe matere (glejte poglavje 4. 3).
4 4.8 Undesirable effects
4 4. 8 Neželeni učinki
The overall percentage of patients who experienced post-dose symptoms were 44.7%, 16.7% and 10.2% after the first, second and third infusion, respectively.
Deleži vseh bolnikov, pri katerih je prišlo do sipmtomov po odmerjanju, so bili po prvi infuziji 44, 7%, po drugi infuziji 16, 7%, po tretji infuziji pa 10, 2%.
Incidence of individual symptoms following the first infusion was: fever (17.1%), myalgia (7.8%), flu-like symptoms (6.7%), arthralgia (4.8%) and headache (5.1%).
Po prvi infuziji so bile incidence posameznih simptomov naslednje: povišana telesna temperatura (17, 1%), mialgija (7, 8%), gripi podobni simptomi (6, 7%), artralgija (4, 8%) in glavobol (5, 1%).
The incidence of these symptoms decreased markedly with subsequent doses of Aclasta.
Incidenca teh simptomov je izrazito upadla pri naslednjih odmerjanjih zdravila Aclasta.
The majority of these symptoms occur within the first three days following Aclasta administration.
Večina teh simptomov je nastopila v prvih treh dneh po aplikaciji zdravila Aclasta.
The majority of these symptoms were mild to moderate and resolved within three days of the event onset.
Večina teh simptomov je bila blagih do zmernih, izzveneli so v treh dneh po nastopu.
The percentage of patients who experienced post-dose symptoms was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion, respectively), where prophylaxis against post-dose symptoms was used as described below.
V manjši študiji, v kateri so uporabljali spodaj opisano profilakso proti simptomom po odmerjanju, so bili deleži vseh bolnikov, pri katerih je prišlo do simptomov po odmerjanju, nižji, in sicer po prvi infuziji 19, 5%, po drugi infuziji 10, 4%, po tretji infuziji pa 10, 7%.
The incidence of post-dose symptoms occurring within the first three days after administration of Aclasta can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta administration (see section 4.2).
Incidenco simptomov po odmerjanju, ki nastopijo v prvih treh dneh po aplikaciji zdravila Aclasta, je mogoče znižati z jemanjem paracetamola ali ibuprofena kmalu po aplikaciji zdravila Aclasta (glejte poglavje 4. 2).
In the HORIZON – Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving Aclasta and placebo, respectively.
V študiji HORIZON – študiji pomembnih zlomov (Pivotal Fracture Trial [PFT], glejte poglavje 5. 1) je bila skupna incidenca atrijske fibrilacije pri bolnikih, ki so prejemali zdravilo Aclasta, 2, 5% (pri 96 od 3. 862 bolnikov), pri bolnikih, ki so prejemali placebo, pa 1, 9% (pri 75 od 3. 852 bolnikov).
The rate of atrial fibrillation serious adverse events was increased in patients receiving Aclasta (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Delež atrijske fibrilacije, ki so jo opredelili kot resen neželen dogodek, je bil pri bolnikih, ki so prejemali zdravilo Aclasta, zvišan (1, 3%) (pri 51 od 3. 862 bolnikov) v primerjavi z bolniki, ki so prejemali placebo (0, 6%) (pri 22 od 3. 852 bolnikov).
The mechanism behind the increased incidence of atrial fibrillation is unknown.
Mehanizem, na katerem temelji zvišana incidenca atrijske fibrilacije, ni znan.
In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between Aclasta (2.6%) and placebo (2.1%).
V študijah osteoporoze (v PFT, v študiji HORIZON – študiji ponovnih zlomov (Recurrent Fracture Trial [RFT]) sta bili združeni incidenci atrijske fibrilacije primerljivi med zdravilom Aclasta (2, 6%) in placebom (2, 1%).
For atrial fibrillation serious adverse events the pooled incidences were 1.3% for Aclasta and 0.8% for placebo.
Združeni incidenci atrijske fibrilacije, ki so jo opredelili kot resen neželen dogodek, sta bili 1, 3% pri zdravilu Aclasta in 0, 8% pri placebu.
Very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000) adverse drug reactions are shown in Table 1.
Zelo pogosti (≥1/ 10), pogosti (≥1/ 100, < 1/ 10), občasni (≥1/ 1. 000, < 1/ 100), redki (≥1/ 10. 000, < 1/ 1. 000) neželeni učinki so prikazani v preglednici 1.
Table 1*
občasni
Investigations Cardiac disorders Nervous system disorders
zvišan krvni tlak
Uncommon Common Common Uncommon
Srčne bolezni
Blood pressure increased Atrial fibrillation Headache, dizziness Lethargy, paraesthesia, somnolence, tremor, syncope
pogosti
Eye disorders
atrijska fibrilacija
Uncommon Rare
Bolezni živčevja
Conjunctivitis, eye pain Uveitis, episcleritis, iritis
glavobol, omotičnost
Ear and labyrinth disorders Respiratory, thoracic and mediastinal disorders
letargija, parestezija, somnolenca, tremor, sinkopa
Uncommon Uncommon
Očesne bolezni
Vertigo Dyspnoea
občasni
Gastrointestinal disorders
konjunktivitis, bolečina v očesu
Common Uncommon
redki občasni
Nausea, vomiting Diarrhoea, dyspepsia, abdominal pain, dry mouth
uveitis, episkleritis, iritis vrtoglavica
Renal and urinary disorders Skin and subcutaneous tissue disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
Uncommon Uncommon
Bolezni prebavil
Blood creatinine increased, pollakiuria Rash, night sweats, hyperhydrosis, pruritus, erythema
navzea, bruhanje
Musculoskeletal and connective tissue disorders
driska, dispepsija, bolečine v trebuhu, suha usta
Common Uncommon
občasni
Myalgia, arthralgia, bone pain, back pain, pain in extremity Neck pain, musculoskeletal stiffness, joint swelling, shoulder pain, muscle spasms, musculoskeletal pain, non-cardiac chest pain, arthritis, muscular weakness, joint stiffness
zvišana vrednost kreatinina v krvi, polakisurija
Metabolism and nutrition disorders
Bolezni kože in podkožja
Hypocalcaemia† Anorexia, decreased appetite
izpuščaj, nočno znojenje, čezmerno znojenje, srbenje, rdečina
5
5 Bolezni mišično- skeletnega sistema in vezivnega tkiva
Infections and infestations Vascular disorders General disorders and administration site conditions
mialgija, artralgija, bolečine v kosteh, bolečine v hrbtu, bolečine v okončinah
Uncommon Uncommon Very common Common
občasni
Influenza Hypertension, flushing Fever Flu-like symptoms, chills, fatigue, asthenia, pain, malaise, rigors†
bolečina v vratu, mišičnoskeletna okorelost, otekanje sklepov, bolečine v rami, mišični spazmi, mišičnoskeletna bolečina, nekardiogena bolečina v prsnem košu, artritis, šibkost mišic, okorelost sklepov
Uncommon
Infekcijske in parazitske bolezni
Peripheral oedema, thirst
anoreksija, zmanjšan apetit gripa
Not known**
občasni
Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/ shock
hipertenzija, navali rdečice
Psychiatric disorders
povišana telesna temperatura
Insomnia
pogosti
* Additional adverse events which were reported in the individual studies but were not included due to the pooled presentation are:
gripi podobni simptomi, mrzlica, utrujenost, astenija, bolečine, splošno slabo počutje, okorelost †
Uncommon: dysgeusia, oesophagitis, toothache. † Common in Paget’ s disease only.
občasni neznana **
For hypocalcaemia, see also text below. ** Based on post-marketing reports.
periferni edemi, žeja preobčutljivostne reakcije, vključno z redkimi primeri bronhospazma, urtikarije in angioedema, in z zelo redkimi primeri anafilaktične reakcije/ šoka
Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency or establish a causal relationship to exposure to the medicinal product.
* drugi neželeni dogodki, ki so jih opisovali v posameznih študijah, vendar zaradi združenega prikaza niso vključeni v preglednico, so: občasni: motnje okušanja, ezofagitis, zobobol † pogosti samo pri Pagetovi bolezni; za hipokalciemijo glejte besedilo v nadaljevanju ** na podlagi postmarketinških poročil; ker ni mogoče določiti velikosti populacije, iz katere izhajajo ta poročila, in ker nanje vplivajo moteči dejavniki, ni mogoče zanesljvo ugotoviti njihove pogostnosti oziroma vzročne povezave z izpostavljenostjo zdravilu.
Renal dysfunction Zoledronic acid has been associated with renal dysfunction manifested as deterioration in renal function (i. e. increased serum creatinine) and in rare cases acute renal failure.
Ledvična disfunkcija Zoledronsko kislino povezujejo z disfunkcijo ledvic ki se kaže kot poslabšanje delovanja ledvic (zvišanje vrednosti kreatinina v serumu) in v redkih primerih z akutno odpovedjo ledvic.
Renal dysfunction has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal compromise or additional risk factors (e. g oncology patients with chemotherapy, concomitant nephrotoxic medications, severe dehydration), the majority of whom received a 4 mg dose every 3– 4 weeks, but it has been observed in patients after a single administration.
Večina teh bolnikov je prejela odmerek 4 mg vsake 3- 4 tedne, težave pa so opažali tudi pri bolnikih po enem samem odmerku.
There was a transient increase in serum creatinine observed within 10 days in 1.8% of Aclasta-treated patients versus 0.8% of placebo-treated patients.
V prvih 10 dneh po odmerjanju je prišlo do prehodnega zvišanja vrednosti kreatinina v serumu pri 1, 8% bolnikov v skupini z zdravilom Aclasta v primerjavi z 0, 8% bolnikov v skupini s placebom.
Hypocalcaemia In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 1.87 mmol/ l) following Aclasta administration.
Hipokalciemija V kliničnih preskušanjih pri osteoporozi je pri 0, 2% bolnikov prišlo do opaznega znižanja koncentracij kalcija v serumu (manj kot 1, 87 mmol/ l) po aplikaciji zdravila Aclasta.
In the Paget’ s disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
V preskušanjih zdravljenja Pagetove bolezni so opažali simptomatsko hipokalciemijo pri približno 1% bolnikov, pri katerih je tudi izzvenela.
Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/ l) occurred in 2.3% of Aclasta-treated patients in a large clinical trial compared to 21% of Aclasta-treated patients in the Paget’ s disease trials.
Na podlagi laboratorijskih preiskav so ugotovili, da je do prehodnega asimptomatskega znižanja koncentracij kalcija pod okvir normalnih referenčnih vrednosti (pod 2, 10 mmol/ l) prišlo pri 2, 3% bolnikov, ki so prejemali zdravilo Aclasta v obsežnem kliničnem preskušanju, v primerjavi z 21% pri
The frequency of hypocalcaemia was much lower following subsequent infusions.
6 bolnikih, ki so prejemali zdravilo Aclasta v preskušanjih zdravljenja Pagetove bolezni.
All patients received adequate supplementation with vitamin D and calcium in the post-menopausal osteoporosis trial, the prevention of clinical fractures after hip fracture trial, and the Paget’ s disease trials (see also section 4.2).
V preskušanju zdravljenja postmenopavzalne osteoporoze, v preskušanju preventive kliničnih zlomov po zlomu kolka in v preskušanjih zdravljenja Pagetove bolezni so vsi bolniki prejemali ustrezne dodatke vitamina D in kalcija (glejte tudi poglavje 4. 2).
In the trial for the prevention of clinical fractures following a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to Aclasta administration (see section 4.2).
V preskušanju preventive kliničnih zlomov po nedavnem zlomu kolka niso rutinsko merili koncentracij vitamina D, vendar je večina bolnikov pred aplikacijo zdravila Aclasta prejela večji začetni odmerek vitamina D (glejte poglavje 4. 2).
Local reactions In a large clinical trial, local reactions at the infusion site, such as redness, swelling and/ or pain, were reported (0.7%) following the administration of zoledronic acid.
Lokalne reakcije V obsežnem kliničnem preskušanju so poročali o lokalnih reakcijah, kot so rdečina, oteklina in/ ali bolečina (0, 7%), po odmerjanju zoledronske kisline.
6 Osteonecrosis of the jaw Uncommonly, cases of osteonecrosis (primarily of the jaw) have been reported, predominantly in cancer patients treated with bisphosphonates, including zoledronic acid.
Osteonekroza čeljusti O osteonekrozi (večinoma čeljusti) so občasno poročali predvsem pri bolnikih z rakom, zdravljenih z difosfonati, vključno z zoledronsko kislino.
Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (e. g. chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (e. g. anaemia, coagulopathies, infection, pre- existing dental disease).
Osteonekroza čeljusti ima številne dobro dokumentirane dejavnike tveganja, ki vključujejo diagnozo raka, sočasno zdravljenje (npr. kemoterapijo, radioterapijo, kortikosteroide) in sočasna bolezenska stanja (npr. anemijo, koagulopatije, infekcijo, predhodno bolezen zob).
Although causality has not been determined, it is prudent to avoid dental surgery as recovery may be prolonged (see section 4.4).
Čeprav vzročna povezanost ni bila ugotovljena, se je smiselno izogibati kirurškim posegom na zobeh, saj lahko podaljšajo čas okrevanja (glejte poglavje 4. 4).
In a large clinical trial in 7,736 patients, osteonecrosis of the jaw has been reported in one patient treated with Aclasta and one patient treated with placebo.
V obsežnem kliničnem preskušanju s 7. 736 bolniki so o osteonekrozi čeljusti poročali pri enem bolniku, ki je prejemal zdravilo Aclasta, in pri enem bolniku, ki je prejemal placebo.
There is no experience of acute intoxication with Aclasta.
O akutni zastrupitvi z zdravilom Aclasta ni izkušenj.
In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/ or an intravenous infusion of calcium gluconate.
Klinično pomembno hipokalciemijo, ki je posledica prevelikega odmerka, lahko odpravimo z dodatkom peroralnega kalcija ali intravensko infuzijo kalcijevega glukonata ali z obema.
Bisphosphonate, ATC code:
Farmakoterapevtska skupina: difosfonati, oznaka ATC:
Mechanism of action Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone.
Način delovanja Zoledronska kislina spada v skupino difosfonatov, ki vsebujejo dušik, in deluje primarno na kost.
Pharmacodynamic effects Aclasta treatment rapidly reduced the rate of bone turnover from elevated post-menopausal levels with the nadir for resorption markers observed at 7 days, and for formation markers at 12 weeks.
Farmakodinamični učinki Zdravljenje z zdravilom Aclasta je hitro znižalo stopnjo kostne presnove z zvišanih postmenopavzalnih vrednosti; vrednosti markerjev resorpcije so bile najnižje po 7 dneh, vrednosti markerjev nastajanja kosti pa po 12 tednih.
Thereafter bone markers stabilised within the pre-menopausal range.
Po tem so se kostni markerji stabilizirali v premenopavzalnem okviru.
There was no progressive reduction of bone turnover markers with repeated annual dosing.
Pri ponovljenem odmerjanju enkrat letno ni prišlo do progresivnega zniževanja vrednosti markerjev kostne presnove.