natgillin/translations-raw huggingface dataset:
På grund af risikoen for esophageal irritation, bør opkastning ikke induceres, og patienten skal forblive i oprejst stilling.
Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Bisphosphonat, ATC- kode:
Bisphosphonates, ATC code:
Virkningsmekanisme Ibandronsyre er et højpotent bisphosphonat, tilhørende gruppen af nitrogen- holdige bisphosphonater, som virker selektivt på knoglevæv og specifikt hæmmer osteoklast aktiviteten uden direkte påvirkning af knogleopbygningen.
Mechanism of action Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act selectively on bone tissue and specifically inhibit osteoclast activity without directly affecting bone formation.
Farmakodynamiske virkninger Den farmakodynamiske virkning af ibandronsyre er hæmning af knogleresorptionen.
Pharmacodynamic effects The pharmacodynamic action of ibandronic acid is inhibition of bone resorption.
Ibandronsyre forhindrer in- vivo eksperimentelt fremkaldt knogledestruktion forårsaget af ophørt gonadefunktion, retinoider, tumorer eller tumorekstrakter.
In vivo, ibandronic acid prevents experimentally induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.
I forsøg med rotter i vækst, fandtes der ikke tegn på nedsat mineralisering, selv ved doser som var 5. 000 gange højere end dosis til osteoporose behandling.
In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment.
I dette studie viste ibandronsyre antifraktur- effekt.
In humans, the efficacy of both daily and intermittent administration with a dose-free interval of 9-10 weeks of ibandronic acid was confirmed in a clinical trial (MF 4411), in which ibandronic acid demonstrated anti-fracture efficacy.
I dyreforsøg producerede ibandronsyre biokemiske ændringer, som indikerer en dosisafhængig hæmning af knogleresorptionen, herunder suppression af biokemiske urinmarkører for nedbrydning af knoglekollagen (som f. eks. deoxypyridinolin og kollagen type 1 krydsbundne N- telopeptider (NTX)).
In animal models ibandronic acid produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including suppression of urinary biochemical markers of bone collagen degradation (such as deoxypyridinoline, and cross-linked N-telopeptides of type I collagen (NTX)).
8 I et fase I bioækvivalens- studie hos 72 postmenopausale kvinder, som fik 150 mg oralt hver 28. dag, i ialt 4 doser, blev der set hæmning af CTX efter første dosis allerede 24 timer efter indtagelsen (median hæmning 28%) med median maksimal hæmning (69%) 6 dage senere.
In a Phase 1 bioequivalence study conducted in 72 postmenopausal women receiving 150 mg orally every 28 days for a total of four doses, inhibition in serum CTX following the first dose was seen as early as 24 hours post-dose (median inhibition 28%), with median maximal inhibition (69%) seen 6 days later.
Efter tredje og fjerde dosis var den mediane maksimale hæmning 6 dage efter indtagelsen 74% med et fald til en median hæmning på 56% 28 dage efter indtagelsen af fjerde dosis.
Following the third and fourth dose, the median maximum inhibition 6 days post dose was 74% with reduction to a median inhibition of 56% seen 28 days following the fourth dose.
Disse er for eksempel lav BMD, alder, eksistens af tidligere frakturer, familiær tendens til frakturer, høj knogleomsætning og lavt body mass index.
Clinical efficacy Independent risk factors, for example, low BMD, age, the existence of previous fractures, a family history of fractures, high bone turnover and low body mass index should be considered in order to identify women at increased risk of osteoporotic fractures.
Knoglemineraltæthed (BMD) I et to- års, dobbeltblindt multicenterstudie (BM 16549) var Bondenza 150 mg én gang om måneden mindst ligeså effektivt som ibandronsyre 2, 5 mg daglig til at øge BMD hos postmenopausale kvinder med osteoporose (lumbal BMD T score under - 2, 5 SD ved baseline).
8 Bone mineral density (BMD) Bondenza 150 mg once monthly was shown to be at least as effective as ibandronic acid 2.5 mg daily at increasing BMD in a two year, double-blind, multicentre study (BM 16549) of postmenopausal women with osteoporosis (lumbar spine BMD T score below -2.5 SD at baseline).
Dette blev vist ved både den primære analyse efter et år og i den bekræftende analyse efter to års endpoint (tabel 3).
This was demonstrated in both the primary analysis at one year and in the confirmatory analysis at two years endpoint (Table 3).
Den gennemsnitlige relative ændring fra baseline for lumbal -, hofte -, lårbenshals - og trochanter BMD efter et år (primær analyse) og to- års behandling (per- protokol population) i studie BM 16549
Mean relative change from baseline of lumbar spine, total hip, femoral neck and trochanter BMD after one year (primary analysis) and two years of treatment (Per-Protocol Population) in study BM 16549.
To- års data fra studie BM 16549
Two year data in study BM 16549
Gennemsnitlige relative ændringer fra baseline% [95% konfidensinterval]
Mean relative changes from baseline% [95% CI]
ibandronsyre Bondenza 150 mg 2, 5 mg daglig én gang om (N=318) måneden (N=320)
ibandronic acid Bondenza 2.5 mg daily 150 mg once (N=318) monthly (N=320)
ibandronsyre Bondenza 150 mg 2, 5 mg daglig én gang om (N=294) måneden (N=291)
ibandronic acid Bondenza 2.5 mg daily 150 mg once (N=294) monthly (N=291)
Lumbal L2- L4 BMD
Total hip BMD
3, 9 [3, 4; 4, 3] 4, 9 [4, 4; 5, 3]
1.9 [1.4, 2.4]
5, 0 [4, 4; 5, 5] 6, 6 [6, 0; 7, 1]
3.1 [2.7, 3.6]
Hofte BMD Lårbenshals BMD Trochanter BMD
Trochanter BMD
2, 0 [1, 7; 2, 3] 3, 1 [2, 8; 3, 4] 1, 7 [1, 3; 2, 1] 2, 2 [1, 9; 2, 6] 3, 2 [2, 8; 3, 7] 4, 6 [4, 2; 5, 1]
4.0 [3.5, 4.5]
2, 5 [2, 1; 2, 9] 4, 2 [3, 8; 4, 5] 1, 9 [1, 4; 2, 4] 3, 1 [2, 7; 3, 6] 4, 0 [3, 5; 4, 5] 6, 2 [5, 7; 6, 7]
6.2 [5.7, 6.7]
Desuden blev det i en prospektiv planlagt analyse vist, at Bondenza 150 mg én gang om måneden var bedre end ibandronsyre 2, 5 mg daglig mht. stigning i lumbal BMD efter et år p=0, 002 og efter to år p < 0, 001.
Furthermore, Bondenza 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p < 0.001.
Efter et år (primær analyse) havde 91, 3% (p=0, 005) af de patienter, som fik Bondenza 150 mg én gang om måneden, en stigning i lumbal BMD over eller lig baseline (BMD respondenter), sammenlignet med 84, 0% af de patienter, som fik ibandronsyre 2, 5 mg daglig.
At one year (primary analysis), 91.3% (p=0.005) of patients receiving Bondenza 150 mg once monthly had a lumbar spine BMD increase above or equal to baseline (BMD responders), compared with 84.0% of patients receiving ibandronic acid 2.5 mg daily.
Efter to år var 93, 5% (p=0, 004) og 86, 4% af de patienter, som fik henholdsvis Bondenza 150 mg én gang om måneden eller ibandronsyre 2, 5 mg daglig, respondenter.
At two years, 93.5% (p=0.004) and 86.4% of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
For hofte BMD havde 90, 0% (p < 0, 001) af de patienter, som fik 150 mg én gang om måneden og 76, 7% af patienterne, som fik ibandronsyre 2, 5 mg daglig, stigninger i hofte BMD over eller lig baseline efter et år.
For total hip BMD, 90.0% (p < 0.001) of patients receiving Bondenza 150 mg once monthly and 76.7% of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline at one year.
Efter to år havde 93, 4% (p < 0, 001) af patienterne, som fik henholdsvis Bondenza 150 mg én gang om måneden og 78, 4% af patienterne, som fik ibandronsyre 2, 5 mg daglig, stigninger i hofte BMD over eller lig baseline.
At two years 93.4% (p < 0.001) of patients receiving Bondenza 150 mg once monthly and 78.4%, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Efter to år mødte 87, 1%
When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9% (p < 0.001) and 65.7% of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
9 (p < 0, 001) og 70, 5% af patienterne dette kriterie i armene for henholdsvis 150 mg én gang om måneden og 2, 5 mg daglig.
At two years, 87.1% (p < 0.001) and 70.5%, of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Biokemiske markører for knogleomsætning Der blev set klinisk betydende reduktioner i serum- CTX- koncentrationerne på alle målte tidspunkter, dvs. efter 3, 6, 12 og 24 måneder.
Biochemical markers of bone turn-over Clinically meaningful reductions in serum CTX levels were observed at all time points measured, i. e. months 3, 6, 12 and 24.
Efter et år (primær analyse) var de mediane, relative ændringer fra baseline - 76% for gruppen, som fik Bondenza 150 mg én gang om måneden og - 67% for gruppen, som fik ibandronsyre 2, 5 mg daglig.
After one year (primary analysis) the median relative change from baseline was -76% for Bondenza 150 mg once monthly and -67% for ibandronic acid 2.5 mg daily.
Efter to år var de mediane, relative ændringer - 68% og - 62% i armene for henholdsvis 150 mg én gang om måneden og 2, 5 mg daglig.
At two years the median relative change was -68% and -62%, in the 150 mg monthly and 2.5 mg daily arms respectively.
Efter et år var 83, 5% (p=0, 006) af patienterne, som fik Bondenza 150 mg én gang om måneden og 73, 9% af patienterne, som fik ibandronsyre 2, 5 mg daglig, identificeret som respondenter (defineret som et fald ≥ 50% fra baseline).
At one year, 83.5% (p= 0.006) of patients receiving Bondenza 150 mg once monthly and 73.9% of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease
Efter to år var 78, 7% (p=0, 002) og 65, 6% af patienterne identificeret som respondenter i armene med henholdsvis 150 mg én gang om måneden og 2, 5 mg daglig.
At two years 78.7% (p=0.002) and 65.6% of patients were identified as responders in the 150 mg monthly and 2.5 mg daily arms respectively.
På grundlag af resultaterne fra studie BM 16549 forventes Bondenza 150 mg én gang om måneden at være mindst ligeså effektivt med hensyn til at forebygge frakturer som ibandronsyre 2, 5 mg daglig.
Based on the results of study BM 16549, Bondenza 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily.
Ibandronsyre 2, 5 mg daglig
Ibandronic acid 2.5 mg daily
I det første tre- års randomiserede, dobbeltblinde, placebokontrollerede frakturstudie (MF 4411) påvistes et statistisk signifikant og medicinsk relevant fald i hyppigheden af nye røntgen - morfometriske og kliniske vertebrale frakturer (tabel 4).
In the initial three-year, randomised, double-blind, placebo-controlled, fracture study (MF 4411), a statistically significant and medically relevant decrease in the incidence of new radiographic morphometric and clinical vertebral fractures was demonstrated (table 4).
I denne undersøgelse blev ibandronsyre undersøgt ved doser på 2, 5 mg daglig og 20 mg intermitterende som et eksploratorisk regime.
In this study, ibandronic acid was evaluated at oral doses of 2.5 mg daily and 20 mg intermittently as an exploratory regimen.
Ibandronsyre blev indtaget 60 minutter før første indtagelse af mad eller drikkevarer (post- dosis fasteperiode).
Ibandronic acid was taken 60 minutes before the first food or drink of the day (post-dose fasting period).
Undersøgelsen omfattede kvinder i alderen 55 til 80 år, som var mindst 5 år postmenopausale, havde et BMD på 2 til 5 SD under den præmenopausale middelværdi (T- score) i mindst én ryghvirvel [L1- L4], og som havde haft 1- 4 tidligere vertebrale frakturer.
The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at lumbar spine of 2 to 5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Alle patienter fik dagligt 500 mg calcium og 400 IE vitamin D.
All patients received 500 mg calcium and 400 IU vitamin D daily.
Ibandronsyre 2, 5 mg administreret dagligt resulterede i en statistisk signifikant og medicinsk relevant reduktion i forekomsten af nye vertebrale frakturer.
Efficacy was evaluated in 2,928 patients. ibandronic acid 2.5 mg administered daily, showed a statistically significant and medically relevant reduction in the incidence of new vertebral fractures.
Dette regime reducerede forekomsten af nye røntgenverificerede vertebrale frakturer med 62% (p=0, 0001) gennem den 3- årige undersøgelsesperiode.
This regimen reduced the occurrence of new radiographic vertebral fractures by 62% (p=0.0001) over the three year duration of the study.
En relativ risikoreduktion på 61% blev observeret efter 2 år (p=0, 0006).
A relative risk reduction of 61% was observed after 2 years (p=0.0006).
Ingen statistisk signifikant forskel blev opnået efter 1 års behandling (p=0, 056).
No statistically significant difference was attained after 1 year of treatment (p=0.056).
Antifraktur effekten var konsistent gennem hele undersøgelsen.
The anti-fracture effect was consistent over the duration of the study.
Hyppigheden af kliniske vertebrale frakturer blev desuden signifikant reduceret med 49% (p=0, 011).
The incidence of clinical vertebral fractures was also significantly reduced by 49% (p=0.011).
Den udtalte effekt på vertebrale frakturer viste sig desuden ved en statistisk signifikant reduktion i højdetab sammenlignet med placebo (p < 0, 0001).
The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p < 0.0001).
Resultater fra 3- års frakturundersøgelsen MF 4411 (%, 95% Konfidensinterval)
Results from 3 years fracture study MF 4411 (%, 95% CI)
Relativ Risiko Reduktion
Relative Risk Reduction New morphometric vertebral fractures
ibandronsyre 2, 5 mg daglig (N=977)
ibandronic acid 2.5 mg daily (N=977) 62% (40.9, 75.1)
Nye morfometriske vertebrale frakturer Hyppighed af nye morfometriske
Incidence of new morphometric vertebral fractures
62% (40, 9; 75, 1)
9.56% (7.5, 11.7)
4, 68%
4.68% (3.2,6.2)
Relativ Risiko Reduktion af kliniske
Relative risk reduction of clinical vertebral fracture
49%
49% (14.03, 69.49)
efter 3 år BMD – gennemsnitlig ændring i
Incidence of clinical vertebral fracture BMD – mean change relative to baseline lumbar spine at year 3
(0, 8; 1, 7)
5.33% (3.73, 6.92) 1.26% (0.8, 1.7)
(6, 1; 7, 0)
2.75% (1.61, 3.89) 6.54% (6.1, 7.0)
forhold til baseline - total hofte - efter 3
BMD – mean change relative to baseline total hip at year 3
3, 36%
-0.69% (-1.0, -0.4)
(- 1, 0; - 0, 4)
3.36% (3.0, 3.7)
Effekten af behandlingen med ibandronsyre blev yderligere vurderet i en analyse af subpopulationen af patienter, som ved baseline havde en lumbal columna BMD T- score under - 2, 5.
The treatment effect of ibandronic acid was further assessed in an analysis of the subpopulation of patients who at baseline had a lumbar spine BMD T-score below – 2.5.
Tabel 5:
10 Table 5:
Resultater fra 3- års frakturundersøgelsen MF 4411 (%, 95% Konfidensinterval) for patienter med lumbal columna BMD T- score under - 2, 5 ved baseline
Results from 3 years fracture study MF 4411 (%, 95% CI) for patients with lumbar spine BMD T-score below – 2.5 at baseline
ibandronsyre 2, 5 mg daglig (N=575)
ibandronic acid 2.5 mg daily (N=575) 59% (34.5, 74.3)
59% (34, 5; 74, 3)
12.54% (9.53, 15.55)
12, 54%
5.36% (3.31, 7.41)
50%
50% (9.49, 71.91)
(9, 49; 71, 91) Hyppighed af kliniske vertebrale
Incidence of clinical vertebral fracture
3, 57%
6.97% (4.67, 9.27)
(1, 89; 5, 24)
3.57% (1.89, 5.24)
forhold til baseline - lumbal columna - efter 3 år BMD – gennemsnitlig ændring i
BMD – mean change relative to baseline lumbar spine at year 3
1, 13% (0, 6; 1, 7)
1.13% (0.6, 1.7)
7, 01% (6, 5; 7, 6)
7.01% (6.5, 7.6)
forhold til baseline - total hofte - efter 3 år
BMD – mean change relative to baseline total hip at year 3
- 0, 70% (- 1, 1; - 0, 2)
-0.70% (-1.1, -0.2)
3, 59% (3, 1; 4, 1)
3.59% (3.1, 4.1)
I den samlede patientpopulation i studie MF4411, sås ingen reduktion af non- vertebrale frakturer, selvom dagligt indtag af ibandronat tilsyneladende havde effekt i en høj- risiko- undergruppe (lårbenshalsen BMD T- score < - 3, 0), hvor en risikoreduktion på 69% blev observeret.
In the overall patient population of the study MF4411, no reduction was observed for non-vertebral fractures, however daily ibandronate appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69% was observed.
Daglig behandling med 2, 5 mg Bondenza resulterede i en tiltagende øgning af BMD både vertebralt og non- vertebralt.
Daily treatment with 2.5 mg resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Der fandtes efter 3 år en lumbal BMD stigning på 5, 3% i forhold til placebo og på 6, 5% i forhold til baseline.
Three-year lumbar spine BMD increase compared to placebo was 5.3% and 6.5% compared to baseline.
Stigningen i BMD i hoften i forhold til baseline var 2, 8% i lårbenshalsen, 3, 4% i hele hoften og 5, 5% i trochanter.
Increases at the hip compared to baseline were 2.8% at the femoral neck, 3.4% at the total hip, and 5.5% at the trochanter.
Biokemiske markører for knogleomsætning (som f. eks. urin CTX og serum osteocalcin) viste det forventede suppressionsmønster til præmenopausale værdier og maksimal suppression opnåedes indenfor 3- 6 måneder.
Biochemical markers of bone turnover (such as urinary CTX and serum Osteocalcin) showed the expected pattern of suppression to premenopausal levels and reached maximum suppression within a period of 3-6 months.
En klinisk relevant reduktion på 50% i biokemiske markører for knogleresorption blev observeret allerede en måned efter start på behandling med ibandronsyre 2, 5 mg.
A clinically meaningful reduction of 50% of biochemical markers of bone resorption was observed as early as one month after start of treatment with ibandronic acid 2.5 mg.
11 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
Den primære farmakologiske effekt af ibandronsyre på knogler er ikke direkte relateret til de aktuelle plasmakoncentrationer, hvilket er påvist i flere undersøgelser på dyr og mennesker.
The primary pharmacological effects of ibandronic acid on bone are not directly related to actual plasma concentrations, as demonstrated by various studies in animals and humans.
Absorption Absorptionen af ibandronsyre i den øvre mavetarmkanal er hurtig efter oral administration og plasmakoncentrationen øges dosisafhængigt op til 50 mg oral indtagelse, mens der ses større end dosis- proportionale stigninger over denne dosis.
Absorption The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration and plasma concentrations increase in a dose-proportional manner up to 50 mg oral intake, with greater than dose-proportional increases seen above this dose.
0, 6%.
Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6%.
Absorptionen nedsættes ved samtidig indtagelse af føde eller drikkevarer (andet end postevand).
The extent of absorption is impaired when taken together with food or beverages (other than plain water).
90%, når ibandronsyre indtages sammen med et almindeligt morgenmåltid i forhold til biotilgængeligheden hos personer i fastetilstand.
Bioavailability is reduced by about 90% when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Distribution Efter initial systemisk eksponering, bindes ibandronsyre hurtigt til knogler eller udskilles med urinen.
11 Distribution After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine.
Hos mennesker er det tilsyneladende terminale fordelingsvolumen mindst 90 liter og det estimeres, at 40- 50% af den cirkulerende dosis bindes til knoglerne.
In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50% of the circulating dose.
Sandsynligheden for interaktioner med andre lægemidler på grund af displacering er derfor ringe.
Protein binding in human plasma is approximately 85% - 87% (determined in vitro at therapeutic concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Metabolisme Der er ikke tegn på, at ibandronsyre metaboliseres i dyr eller mennesker.
Metabolism There is no evidence that ibandronic acid is metabolised in animals or humans.
Elimination Den absorberede del af ibandronsyre elimineres fra cirkulationen via knogleabsorption (estimeret til 40- 50% hos postmenopausale kvinder), og den resterende del udskilles uændret via nyrerne.
Elimination The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50% in postmenopausal women) and the remainder is eliminated unchanged by the kidney.
Den ikke- absorberede del af ibandronsyre udskilles i uændret form via fæces.
The unabsorbed fraction of ibandronic acid is eliminated unchanged in the faeces.
Den tilsyneladende terminale halveringstid er generelt i området 10- 72 timer.
The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10-72 hours.
Da de beregnede værdier for det meste er en funktion af studiets varighed, den anvendte dosis og analysens følsomhed, er den sande terminale halveringstid sandsynligvis væsentlig højere, ligesom hos andre bisphosphonater.
As the values calculated are largely a function of the duration of study, the dose used, and assay sensitivity, the true terminal half-life is likely to be substantially longer, in common with other bisphosphonates.
De tidlige plasma- værdier falder hurtigt, og når 10% af peakværdien indenfor 3 og 8 timer efter henholdsvis intravenøs og oral administration.
Early plasma levels fall quickly reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Den totale clearance af ibandronsyre er lav med middelværdier i området 84- 160 ml/ min.
Total clearance of ibandronic acid is low with average values in the range 84-160 ml/ min.
60 ml/ min hos raske postmenopausale kvinder) udgør 50- 60% af den totale clearance og er relateret til kreatininclearance.
Renal clearance (about 60 mL/ min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Race Der er ikke noget, der tyder på en klinisk relevant inter- etnisk forskel i tilstedeværelsen af ibandronsyre mellem asiater og kaukasere.
Race There is no evidence for any clinically relevant inter-ethnic differences between Asians and Caucasians in ibandronic acid disposition.
Patienter med nedsat nyrefunktion Den renale clearance for ibandronsyre hos patienter med forskellige grader af nedsat nyrefunktion er lineært relateret til kreatininclearance.
Patients with renal impairment Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance.
12 Dosisjustering er ikke nødvendig for patienter med mild eller moderat nyrefunktionsnedsættelse (CLcr ≥ 30 ml/ min), som vist i studie BM 16459, hvor de fleste patienter havde mild til moderat nyrefunktionsnedsættelse.
No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or greater than 30 ml/ min), as shown in study BM 16549 where the majority of patients had mild to moderate renal impairment.