natgillin/translations-raw huggingface dataset:
• Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne. • Abnormiteter i oesophagus og andre faktorer, som forsinker tømningen af spiserøret, såsom striktur eller akalasi. • Manglende evne til at stå eller sidde oprejst i mindst 30 minutter. • Hypokalcæmi.
• 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.
4. 3).
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).
Patienterne skal instrueres i at stoppe behandlingen med alendronat og søge læge, hvis de udvikler symptomer på oesophagusirritation såsom fx dysfagi, smerter ved synkning, retrosternal smerte, ny eller forværret halsbrand.
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.
8 Risikoen for at få alvorlige spiserørsbivirkninger synes større hos patienter, der ikke tager alendronat som foreskrevet og/ eller fortsætter med at tage alendronat efter at have udviklet symptomer, der tyder på spiserørsirritation.
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.
4. 2).
It is very important that complete administration instructions are given to, and understood, by the patient (see section 4.2).
4. 8).
A causal relationship cannot be excluded (see section 4.8).
4. 2).
Alendronate is not recommended for patients with impaired renal function if the GFR is less than 35 ml/ min (see section 4.2).
4. 3).
Hypocalcaemia must be corrected before treatment with alendronate is initiated (see section 4.3).
D- vitaminmangel og hypoparathyreoidisme) bør også behandles effektivt før initiering af behandling med alendronat.
Other disorders of mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting alendronate.
I sjældne tilfælde har der imidlertid været rapporter om symptomatisk hypokalcæmi, som til tider har været alvorlig og ofte forekom hos patienter med prædisponerende tilstande (f. eks. hypoparathyreoidisme, D- vitaminmangel og ved kalcium- malabsorption).
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).
Hos cancerpatienter, der blev behandlet med primært intravenøse bisphosphonater, er der rapporter om osteonekrose af kæben, generelt forbundet med tandudtrækning og/ eller lokal infektion (herunder osteomyelitis).
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.
Før der indledes en behandling med bisphosphonater hos patienter med samtidige risikofaktorer (f. eks. cancer, kemoterapi, stråleterapi, kortikosteroidbehandling eller dårlig tandhygiene), bør det overvejes at undersøge tænderne og gennemføre forebyggende tandpleje.
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).
Behandlingsplanen for den enkelte patient bør baseres på den behandlende læges kliniske vurdering af fordele og ricisi.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Der er rapporter om knogle -, led og muskelsmerter hos patienter, der tager bisphosphonater.
Bone, joint, and/ or muscle pain has been reported in patients taking bisphosphonates.
4. 8).
In post- marketing experience, these symptoms have rarely been seen and/ or incapacitating (see section 4.8).
Alendronat HEXAL- tabletter indeholder lactose.
Alendronate HEXAL tablets contain lactose.
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Derfor skal patienterne vente mindst 30 minutter efter indtagelsen af alendronat, før andre perorale lægemidler indtages (se pkt.).
Patients must therefore wait for at least 30 minutes after taking alendronate before taking any other oral medicine (see section 4.2).
5. 3).
Alendronate given to pregnant rats caused hypocalcaemia-related dystocia (see section 5.3).
Bivirkninger, der blev indberettet af investigatorerne, som værende mulige, sandsynlige eller med sikkerhed relaterede til lægemidlet er vist nedenfor, såfremt forekomsten i behandlingsgrupperne i den 1- årige undersøgelse var ≥1%, eller såfremt forekomsten i en af de 3- årige undersøgelser var ≥1% hos de patienter, som var i behandling med alendronat 10 mg dagligt, og denne forekomst var større end hos de patienter, der fik placebo:
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.
Gastrointestinale sygdomme
Three-year studies Gastrointestinal
(n=196)%
Alendronate10 mg daily (n=196)%
(n=397)%
Placebo (n=397)%
Abdominalsmerter Dyspepsi Syreregurgitation Kvalme Abdominal udspiling Obstipation Diarré Dysfagi Flatulens
Abdominal pain Dyspepsia Acid regurgitation Nausea Abdominal distension Constipation Diarrhoea Dysphagia Flatulence
6, 6 3, 6 2, 0 3, 6 1, 0 3, 1 3, 1 1, 0 2, 6
6.6 3.6 2.0 3.6 1.0 3.1 3.1 1.0 2.6
4, 8 3, 5 4, 3 4, 0 0, 8 1, 8 1, 8 0, 0 0, 5
4.8 3.5 4.3 4.0 0.8 1.8 1.8 0.0 0.5
10
10 Three-year studies
Gastritis Gastrisk ulcus Oesophagus ulcus Bevægeapparat og bindevæv
Gastritis Gastric ulcer Oesophageal ulcer Musculoskeletal
0, 5 0, 0 1, 5
0.5 0.0 1.5
1, 3 0, 0 0, 0
1.3 0.0 0.0
Smerter i bevægeapparatet og bindevæv (knogler, muskler eller led)
Musculoskeletal pain (bone, muscle or joints)
Muskelkramper Sygdomme i nervesystemet
Muscle cramps Neurological
Følgende bivirkninger er blevet indberettet under kliniske undersøgelser og/ eller efter markedsføring:
The following undesirable effects have also been reported in clinical trials and/ or post marketing:
Meget almindelig (≥1/ 10) Almindelig (≥1/ 100 til, < 1/ 10) Ikke almindelig (≥1/ 1. 000 til, < 1/ 100) Sjælden (≥1/ 10. 000 til, < 1/ 1. 000) Meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
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)
Almindelig (≥1/ 100 og < 1/ 10):
Common (≥ 1/ 100, < 1/ 10):
Sjælden (≥1/ 10. 000 og < 1/ 1. 000):
Rare (≥ 1/ 10,000, < 1/ 1000):
Uveitis, scleritis, episcleritis.
Uveitis, scleritis, episcleritis
Abdominalsmerter, dyspepsi, obstipation, diaré, flatulens, oesophagus ulcus *, dysfagi *, abdominal udspiling, syreregurgitation.
Abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcers*, dysphagia*, abdominal distension, acid regurgitation.
Ikke almindelig (≥1/ 1. 000 og < 1/ 100):
Uncommon (≥ 1/ 1000, < 1/ 100):
Kvalme, opkastning, gastritis, oesophagitis *, oesophageale erosioner *, melæna.
Nausea, vomiting, gastritis, oesophagitis* oesophageal erosions*, melaena.
Oesophagusstriktur *, oropharyngeal ulceration *, øvre gastrointestinale PUB (perforationer, ulcera, blødning), kausal sammenhæng kan ikke udelukkes.
Oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUB (perforations, ulcers, bleeding), a causal relationship cannot be ruled out.
Der findes enkeltstående rapporter om oesophagusperforation.
Very rare, not known: perforation of the oesophagus was reported in isolated cases
4. 2 og 4. 4
*See section 4.2 and 4.4.
Meget sjælden (≥1/ 10. 000):
Very rare (≤ 1/ 10,000):
Der er rapporter om enkeltstående tilfælde af alvorlige hudreaktioner inklusiv Stevens- Johnson’ s syndrom og toksisk epidermal nekrolyse.
Isolated cases of severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Almindelig (≥1/ 100, < 1/ 10):
Common (≥ 1/ 100, < 1/ 10):
Muskuloskeletale smerter (knogle -, muskel - eller ledsmerter).
Musculoskeletal pain (bones, muscles or joints) Rare (≥ 1/ 10,000, < 1/ 1000):
4. 4) Ukendt frekvens:
Severe musculoskeletal (bone, muscle or joint pain) (see section 4.4) Unknown frequency:
Ikke almindelig (≥1/ 1. 000, < 1/ 100):
Uncommon (≥ 1/ 1000, < 1/ 100):
Udslæt, kløe, erythem.
Rash, pruritus, erythema.
Sjælden (≥1/ 10. 000, < 1/ 1. 000):
Rare (≥ 1/ 10,000, < 1/ 1000):
Overfølsomhedsreaktioner, herunder urticaria og angioødem.
Hypersensitivity reactions including urticaria and angioedema.
4. 4).
Section 4.4).
Svimmelhed
11 During post-marketing experience the following reactions have been reported (frequency unknown):
Vertigo
Nervous system disorders: dizziness
Almene symptomer og reaktioner på administrationsstedet:
Ear and labyrinth disorders: vertigo
Knogler, led, muskler og bindevæv:
General disorders and administration site conditions: asthenia, peripheral oedema
Der er rapporter om osteonekrose i kæben hos patienter, som blev behandlet med bisphosphonater.
Musculoskeletal and connective tissue disorders: Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Osteonekrose i kæben er generelt forbundet med tandudtrækning og/ eller lokal infektion (herunder osteomyelitis).
Osteonecrosis of the jaw is generally associated with tooth extraction and/ or local infection (including osteomyelistis).
Hævede led.
Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4). joint swelling
Laboratoriefund:
Laboratory values:
Der er i kliniske forsøg set asymptomatiske, milde og forbigående fald i serumkalcium og serumfosfat hos henholdsvis ca.
In clinical trials, asymptomatic, slight and transient decreases in serum calcium and serum phosphate were observed in approx.
12% og 3% af de patienter, der fik placebo.
18 and 10% respectively of the patients taking alendronate 10 mg/ day versus 12 and 3% respectively of those taking placebo.
Forekomsterne af fald i serumkalcium til < 2, 0 mol/ l og i serumfosfat til ≤0, 65 mmol/ l lignede imidlertid hinanden i begge behandlingsgrupper.
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.
Peroral overdosering kan forårsage hypokalcæmi, hypofosfatæmi og symptomer i den øvre gastrointestinalkanal, som f. eks. mavetilfælde, halsbrand, oesophagitis, gastritis eller ulcus.
Hypocalcaemia, hypophosphataemia and upper gastrointestinal side effects such as upset stomach, heartburn, oesophagitis, gastritis or ulcer can occur on oral overdosage.
Lægemidler til behandling af knoglesygdomme, bisphosphonater, ATC - kode:
ATC code:
M 05 BA 04.
M05BA04
Det aktive indholdsstof i Alendronat HEXAL- tabletterne, natriumalendronattrihydrat, er et bisphosphonat, som hæmmer osteoklasternes knogleresorption uden at have en direkte effekt på knogleformationen.
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.
Osteoporose defineres som en knoglemineraltæthed (BMD, bone mineral density) i rygrad eller hofte, der er 2, 5 standarddeviationer under gennemsnitsværdien for en normal yngre population, eller som en tidligere skørhedsfraktur uanset BMD.
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.
Alendronats effekt på BMD og forekomsten af frakturer hos postmenopausale kvinder er undersøgt i to ens tilrettelagte, indledende effekt- undersøgelser (n=994), samt i undersøgelsen ” Fracture Intervention Trial ” (FIT: n=6. 459).
The effects of alendronate on BMD and fracture incidence in post-menopausal women were studied in two initial efficacy studies of identical design (n=994), and in the Fracture Intervention Trial (FIT: n=6459).
I de indledende effekt- undersøgelser var de gennemsnitlige stigninger i BMD efter 3 års behandling med alendronat 10 mg dagligt på henholdsvis 8, 8%; 5, 9% og 7, 8% i rygrad, lårbenshals og trochanter, sammenlignet med placebo.
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 behandlet med alendronat, blev den andel af patienter, der fik en eller flere vertebralfrakturer, reduceret med 48% (alendronat 3, 2% mod placebo 6, 2%).
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%).
FIT- studiet bestod af to placebokontrollerede undersøgelser med alendronat (5 mg dagligt i 2 år og 10 mg dagligt i yderligere enten 1 eller 2 år): • FIT 1:
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:
En 3- årig undersøgelse af 2. 027 patienter som havde haft mindst en vertebral - (kompressions -) fraktur ved baseline.
A three-year study with 2027 patients who had had at least one baseline vertebral (compression) fracture.
I denne undersøgelse reducerede alendronat, administreret 1 gang dagligt, forekomsten af ≥1 ny vertebralfraktur med 47% (alendronat 7, 9% mod placebo 15, 0%).
In this study alendronate daily reduced the incidence of ≥ 1 new vertebral fracture by 47% (alendronate 7.9% versus placebo 15.0%).
Derudover fandtes en statistisk signifikant reduktion i forekomsten af hoftefrakturer (1, 1% mod 2, 2%, en reduktion på 51%). • FIT 2:
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:
En 4- årig undersøgelse af 4. 432 patienter med lav knoglemasse men uden vertebralfraktur ved baseline.
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.
I denne undersøgelse blev der observeret en signifikant forskel ved en analyse af sub - gruppen af kvinder med osteoporose (37% af den samlede population, som havde osteoporose, der svarede til den ovennævnte definition) i forekomsten af hoftefrakturer (alendronat 1, 0% mod placebo 2, 2%, en reduktion på 56%) og i forekomsten af ≥1 vertebralfraktur (2, 9% mod 5, 8%, en reduktion på 50%).
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%).
Effekten at alendronat 10 mg administreret 1 gang dagligt hos mænd (31- 87 år gamle, gennemsnitsalder 63 år, n=241) med osteroporose blev evalueret i en toårig undersøgelse.
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.
Efter 2 års behandling med alendronat 10 mg dagligt øgedes BMD med gennemsnitligt 5, 3% i rygraden, med 2, 6% i lårbenshalsen, med 3, 1% i trochanter og med 1, 6% i skelettet som helhed, i forhold til placebo (p < 0, 001 for alle måleværdier).
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).
I en retrospektiv analyse (kvantitativ røntgenvaluering) blev der dokumenteret en ny fraktur (0, 8%) blandt de patienter, der var blevet behandlet med alendronat, over for 6 nye frakturer (7, 1%) med placebo (p=0, 017).
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).
Reduktion af højden var mindre ved behandling med alendronat i forhold til placebo (hhv. - 0, 6 mm og - 2, 4 mm, p=0, 02).
The reduction in height was less after treatment with alendronate, relative to placebo (-0.6 mm and -2.4 mm respectively, p=0.02).
Der sås ingen effekt på ikke- vertebrale frakturer.
No effect on non- vertebral fractures was seen.
Glukokotikoidudløst osteoporose Langtidsbrug af steroider forbindes ofte med udviklingen af osteoporose efterfulgt af frakturer.
Glucocorticoid-induced osteoporosis Long-term use of steroids is often associated with the development of osteoporosis accompanied by fractures.
Virkningen af alendronat 10 mg og alendronat 5 mg, administreret 1 gang dagligt til mænd og kvinder, som blev behandlet med steroider (mindst 7, 5 mg/ dagligt af lægemidlet prednisolon eller ækvivalent lægemiddel, median dosis 10 mg/ dagligt) blev undersøgt i to enårige næsten identisk tilrettelagte undersøgelser.
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.
I disse undersøgelser var der inkluderet i alt 560 patienter i alderen 17- 83 år.
These studies involved a total of 560 patients aged 17-83 years.
Patienterne fik kalcium - og vitamin D- tilskud.
The patients received calcium and vitamin D supplements.
I forhold til placebo var der en signifikant øgning af BMD i rygrad (2, 41%), lårbenshals (2, 19%) og trochanter (1, 65%) hos de patienter, der blev behandlet med alendronat 5 mg 1 gang dagligt.
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.
Ved administration af alendronat 10 mg 1 gang dagligt svarede den øgede BMD hos alle patienter til den, der fremkom ved administration af alendronat 5 mg 1 gang dagligt med undtagelse af postmenopausale kvinder, som ikke var i østrogenbehandling.
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.
Hos denne gruppe kvinder var øgningen (i forhold til placebo) større med alendronat 10 mg 1 gang dagligt end med alendronat 5 mg 1 gang dagligt i rygrad (4, 11% mod 1, 56%) og trochanter (2, 84% mod 1, 67%).
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%).
Det er endnu ikke godtgjort at øgningen af knoglemineraltætheden med alendronat 10 mg eller alendronat 5 mg har en profylaktiske effekt mod frakturer ved kortikosteroidudløst osteoporose.
The fracture-preventing effect of increasing bone density with alendronate 10 mg or alendronate 5 mg in corticosteroid- induced osteoporosis has not been established.
Dette galt også for både alendronat 10 mg og 5 mg uanset alder (både < 65 år og ≥65 år), køn, BMD ved baseline, gennemsnitlig knogleomsætning ved baseline eller samtidig brug af forskellige andre almindeligt brugte lægemidler.
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.
Hos de patienter, der fik alendronat i doser på op til 10 mg dagligt og som fik gennemført en biopsi efter 1 år, var der ingen tegn på forstyrrelser i knoglemineraliseringsprocessen.
In the patients who received alendronate in doses up to 10 mg daily and in whom
13 5. 2 Farmakokinetiske egenskaber
13 biopsy was performed after one year no signs of a disturbance of the bone mineralisation process were seen.
Absorption Den gennemsnitlige, perorale biotilgængelighed for alendronat var - sammenlignet med en intravenøs referencedosis - på 0, 64% hos kvinder ved doser fra 5- 70 mg, når det blev administreres efter en nats faste og 2 timer før et standardiseret morgenmåltid.
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.
0, 46% og 0, 39%, når alendronat blev administreret en time, eller en halv time, før et standardiseret morgenmåltid.
Bioavailability decreased to an estimated 0.46% and 0.39% when alendronate was given an hour or half an hour before a standardised breakfast.
I osteoporose- undersøgelser havde alendronat effekt når det blev administreret mindst 30 minutter før dagens første måltid eller indtag af drikkevarer.
In osteoporosis studies alendronate was effective when it was given at least 30 minutes before the first meal or drink of the day.
Samtidig administration af alendronat og kaffe eller appelsinjuice reducerede biotilgængeligheden med ca.
Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approx.
60%.
60%.
Hos raske forsøgspersoner førte peroral administreret prednison (20 mg 3 gange dagligt i 5 dage) ikke til nogen klinisk relevant forandring af alendronats perorale biotilgængelighed (gennemsnitlig stigning fra 20- 44%).
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%).
Distribution Forsøg med rotter viser, at alendronat initialt distribueres i blødt væv efter intravenøs administration af 1 mg/ kg, men herefter hurtigt redistribueres til knogler eller udskilles i urinen.
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.
Det gennemsnitlige steady state- fordelingsrum, undtagen for knogler, er mindst 28 liter hos mennesker.
The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans.
Plasmakoncentrationer af lægemidlet efter terapeutiske, orale doser er for lave til at kunne analyseres (≤5 ng/ ml).
Concentrations of active substance in plasma following therapeutic oral doses are too low for analytical detection (< 5 ng/ ml).
50% af radioaktiviteten i urinen inden for 72 timer, og meget lidt eller ingen radioaktivitet genfindes i fæces.
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.