natgillin/translations-raw huggingface dataset:
Patienter med svært nedsat nyrefunktion (CLcr < 30 ml/ min) som fik 10 mg oral ibandronsyre dagligt i 21 dage, havde 2- 3 gange højere plasmakoncentrationer end personer med normal nyrefunktion og den totale ibandronsyre clearance var 44 ml/ min.
Subjects with severe renal failure (CLcr less than 30 ml/ min) receiving daily oral administration of 10 mg ibandronic acid for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function and total clearance of ibandronic acid was 44 ml/ min.
Efter intravenøs administration af 0, 5 mg faldt den totale, renale og ikke- renale clearance hos patienter med svær nyrefunktions- nedsættelse, med henholdsvis 67%, 77% og 50%, men der fandtes ikke nedsat tolerabilitet i forbindelse med den øgede eksponering.
After intravenous administration of 0.5 mg, total, renal, and non-renal clearances decreased by 67%, 77% and 50%, respectively, in subjects with severe renal failure but there was no reduction in tolerability associated with the increase in exposure.
På grund af begrænsede erfaringer, kan Bondenza ikke anbefales til patienter med svært nedsat nyrefunktion, (se pkt 4. 2 og pkt 4. 4).
Due to the limited clinical experience, Bondenza is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Patienter med nedsat leverfunktion Der er ingen farmakokinetiske data for ibandronsyre hos patienter med nedsat leverfunktion.
Patients with hepatic impairment There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Ældre population I en multivariant analyse kunne alder ikke påvises som en uafhængig faktor for nogen af de undersøgte farmakokinetiske parametre.
12 Elderly Population In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Pædiatrisk population Der findes ikke data vedrørende brugen af Bondenza til disse aldersgrupper.
Paediatric population There are no data on the use of Bondenza in these age groups.
Hos hunde blev der kun iagttaget toksiske virkninger f. eks. tegn på renal skade ved eksponering, som anses for i tilstrækkelig grad at overstige maksimal eksponering for mennesker, og disse derfor kun er af ringe relevans for klinisk brug.
Toxic effects, e. g signs of renal damage, were observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Mutagenicitet/ carcinogenicitet:
Mutagenicity/ Carcinogenicity:
Bivirkningerne af ibandronsyre hos rotter i reproduktionstoksicitets- undersøgelserne var de samme som for øvrige bisphosphonater.
Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Tabletkerne Lactosemonohydrat Povidon Mikrokrystallinsk cellulose Crospovidon Stearinsyre 13 Kolloidt, vandfrit silica
Tablet core Lactose monohydrate Povidone Cellulose, microcrystalline Crospovidone Stearic acid Silica, colloidal anhydrous
Tabletovertræk Hypromellose Titandioxid E171 Talcum Makrogol 6000
Tablet coat Hypromellose Titanium dioxide E171 Talc Macrogol 6,000
6. 5 Emballage og pakningsstørrelser
13 6.5 Nature and contents of container
Bondenza 150 mg filmovertrukne tabletter leveres i blisterpakninger (PVC/ PVDC) indeholdende 1 eller 3 tabletter.
Bondenza 150 mg film-coated tablets are supplied in blisters (PVC/ PVDC) containing 1 or 3 tablets.
14 10.
14 1.
En fyldt injektionssprøjte med 3 ml opløsning, indeholder 3 mg ibandronsyre (som 3, 375 mg ibandronsyre som ibandronnatrium monohydrat).
One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as 3.375 mg ibandronic acid, monosodium salt, monohydrate).
Injektionsvæske, opløsning..
Solution for injection.
Den anbefalede dosis af ibandronsyre er 3 mg hver 3. måned, administreret som en intravenøs injektion over 15 - 30 sekunder.
The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 15 - 30 seconds, every three months.
4. 4 og 4. 5).
Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5)
Specielle populationer Patienter med nedsat nyrefunktion Dosisjustering er ikke nødvendig hos patienter med mild eller moderat nyreinsufficiens, hvor serumkreatinin er lig med eller mindre end 200 μmol/ l (2, 3 mg/ dl) eller hvor kreatininclearance (målt eller estimeret) er højere end eller lig med 30 ml/ min.
Special Populations Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment where serum creatinine is equal or below 200 μ mol/ l (2.3 mg/ dl) or where creatinine clearance (measured or estimated) is equal or greater than 30 ml/ min.
4. 4 og 5. 2).
Bondenza injection is not recommended for use in patients who have a serum creatinine above 200 μ mol/ l (2.3 mg/ dl) or who have a creatinine clearance (measured or estimated) below 30 ml/ min, because of limited clinical data available from studies including such patients (see section 4.4 and section 5.2)
5. 2).
Patients with hepatic impairment No dose adjustment is required (see section 5.2).
5. 2).
Elderly Population No dose adjustment is required (see section 5.2).
Pædiatrisk population Anvendelse af Bondenza er ikke relevant hos børn og der er ingen erfaring med behandling af børn.
15 Paediatric Population There is no relevant use of Bondenza in children, and Bondenza was not studied in the paediatric population.
16 Indgivelsesmåde:
Method of Administration:
4. 4).
Strict adherence to the intravenous administration route is required (see section 4.4).
4. 4)
- Hypocalcaemia (see section 4.4)
Administrationsfejl Proceduren for intravenøs administration skal nøje overholdes.
Administration failures Strict adherence to the intravenous route of administration is required.
Der skal udvises forsigtighed for ikke at give Bonvivia- injektionerne intraarterielt eller paravenøst, da det kan medføre vævsskader.
Care must be taken not to administer Bondenza injection via intra-arterial or paravenous administration as this could lead to tissue damage.
Hypercalæmi Bondenza kan, ligesom andre intravenøst administrerede bisphosphonater, forårsage et forbigående fald i værdierne for serum calcium.
Hypocalcaemia Bondenza, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Eksisterende hypocalcæmi bør behandles, før i. v. behandling med Bondenza initieres.
Existing hypocalcaemia must be corrected before starting Bondenza injection therapy.
Andre forstyrrelser i knogle – og mineralstofskiftet bør ligeledes behandles effektivt før behandlingen med Bondenza- injektioner påbegyndes.
Other disturbances of bone and mineral metabolism should also be effectively treated before starting Bondenza injection therapy.
Alle patienter skal have et tilstrækkeligt tilskud af calcium og D- vitamin.
All patients must receive adequate supplemental calcium and vitamin D.
Nedsat nyrefunktion I henhold til god klinisk praksis, bør patienter med sygdomme eller patienter som tager anden medicin, der kan påvirke nyrefunktionen, regelmæssigt kontrolleres under behandlingen.
Renal impairment Patients with concomitant diseases, or who use medicinal products which have potential for undesirable effects on the kidney, should be reviewed regularly in line with good medical practice during treatment.
4. 2 og 5. 2).
Due to limited clinical experience, Bondenza injection is not recommended for patients with a serum creatinine above 200 μ mol/ l (2.3 mg/ dl) or with a creatinine clearance below 30 ml/ min (see section 4.2 and section 5.2).
Knoglerekrose i kæben Knoglenekrose i kæben, normalt set ved tandudtrækning og / eller lokal infektion (herunder osteomyelitis), er rapporteret blandt cancerpatienter, der får behandlingsregimer primært med intravenøst administrerede bisphosphonater.
Osteonecrosis of the jaw 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.
En tandundersøgelse med passende præventiv tandbehandling bør overvejes hos patienter med samtidige risikofaktorer (som cancer, kemoterapi, strålebehandling, kortikosteroider, dårlig mundhygiejne) før behandling med bisphosphonater.
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).
4. 5 Interaktion med andre lægemidler og andre former for interaktion
16 4.5 Interaction with other medicinal products and other forms of interaction
Plasmaproteinbindingen er ca.
Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats.
85% - 87% (bestemt in vitro ved terapeutiske ibandronsyrekoncentrationer), og interaktioner med andre lægemidler på grund af displacering, er derfor usandsynlig.
Furthermore, plasma protein binding is approximately 85% - 87% (determined in vitro at therapeutic ibandronic acid concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Ibandronsyre elimineres udelukkende ved renal ekskretion og gennemgår ikke 17 biotransformation.
Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation.
Farmakokinetiske interaktionsundersøgelser hos postmenopausale kvinder har vist, at der ikke er interaktion med tamoxifen eller hormonsubstitutionsbehandling (østrogen).
Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (oestrogen).
Der er ikke set interaktion ved samtidig administration af melphalan/ prednisolon hos patienter med myelomatose.
No interaction was observed when co-administered with melphalan/ prednisolone in patients with multiple myeloma.
5. 3).
Studies in rats have shown some reproductive toxicity (see section 5.3).
Bondenza bør ikke anvendes under amning
Bondenza should not be used during lactation.
Sikkerheden af oral behandling med ibandronsyre 2, 5 mg en gang daglig er undersøgt hos 1251 patienter, som indgik i 4 placebo- kontrollerede kliniske undersøgelser; 73% af patienterne kom fra det pivotale 3- års studie (MF 4411).
The safety of oral treatment with ibandronic acid 2.5 mg once daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies; 73% of these patients came from the pivotal three-year treatment study (MF 4411).
Det totale antal patienter, som havde en bivirkning med sandsynlig eller mulig relation til forsøgslægemidlet, var i det pivotale behandlingsforsøg (MF 4411) 19, 8% for ibandronsyre 17, 9% for placebo.
The overall proportion of patients who experienced an adverse reaction, i. e. adverse event with a possible or probable relationship to trial medicinal product, in the pivotal treatment study (MF 4411) was 19.8% for ibandronic acid and 17.9% for placebo.
I det pivotale to- års studie hos postmenopausale kvinder med osteoporose (BM 16550) var sikkerheden af i. v. behandling med Bondenza 3 mg hver 3 måned og oral ibandronsyre 2, 5 mg daglig den samme.
In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of Bondenza 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
Det totale antal patienter, som havde en bivirkning, var 26, 0% og 28, 6% Bondenza 3 mg injektion hver 3. måned og 20, 4% og 22, 6% for oral ibandronsyre 2, 5 mg daglig efter henholdsvis et og to år.
The overall proportion of patients who experienced an adverse reaction was 26.0% and 28.6% for Bondenza 3 mg injection every 3 months and 20.4% and 22.6% for oral ibandronic acid 2.5 mg daily after one year and two years, respectively.
De fleste tilfælde af bivirkninger førte ikke til afbrydelse af behandlingen.
Most cases of adverse reactions did not lead to cessation of therapy.
Af tabel 1 og 2 fremgår bivirkningerne med sandsynlig eller mulig relation til forsøgslægemidlet efter et og to års behandling fra det pivotale fase III studie BM 16550 og rapporteret hos mere end 1% af patienterne, behandlet med enten intravenøs injektion af Bondenza 3 mg hver 3. måned eller intravenøs injektion af placebo plus oral ibandronsyre 2, 5 mg daglig.
Table 1 and table 2 list adverse events after one year and two years of treatment, respectively, from the pivotal phase III trial BM16550, reported as possibly or probably related to trial medicinal product, in more than 1% of the patients treated with either intravenous injection of Bondenza 3 mg every 3 months or intravenous injection of placebo plus oral ibandronic acid 2.5 mg daily.
Bivirkninger, som blev rapporteret hos patienter behandlet med injektion af Bondenza 3 mg, med en hyppighed svarende til eller mindre end hos oralt behandlede patienter er ikke inkluderet.
Adverse reactions reported in patients treated with Bondenza 3 mg injection at a frequency equal to or less than that in orally treated patients, are not included.
Af tabel 1 og 2 fremgår også bivirkningerne hos patienter behandlet i 3 år med oral ibandronsyre 2, 5 mg daglig i anti- fraktur- studiet (MF 4411).
Tables 1 and 2 also show adverse reactions in patients treated for 3 years with oral ibandronic acid 2.5 mg daily in the anti-fracture study (MF4411).
For begge studier vises de bivirkninger, som forekom hyppigere hos de ibandronsyrebehandlede patienter i forhold til de placebobehandlede patienter i studie MF 4411.
For both studies, adverse reactions are listed which occurred with a higher incidence in ibandronic acid -treated
Inden for hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter, hvor alvorlige bivirkningerne er.
17 patients compared with the placebo-treated patients of study MF4411.
18 Tabel 1:
Table 1:
Almindelige bivirkninger (> 1/ 100, ≤ 1/ 10), bedømt af investigator til at være sandsynlig eller mulig relateret til forsøgslægemidlet, fra fase III studiet BM16550 om osteoporose efter et års behandling og fra fase III anti- fraktur- studiet MF 4411 efter 3 års behandling.
Common adverse reactions (> 1/ 100, ≤ 1/ 10) in the phase III osteoporosis study BM16550 after one year of treatment and in the phase III anti-fracture study MF 4411 (three-year study), that were considered by the investigator to be possibly or probably related to study medicinal product.
Et- årsdata fra studie BM 16550
One year data in study BM
Tre- årsdata fra studie MF 4411
Three year data in 4411
Placebo
study MF
bivirkning
System Organ Class/ Adverse reaction Gastrointestinal disorders
3 mg hver 3. måned
(%)
oral ibandronsyre
Placebo injection + oral ibandronic acid 2.5 mg daily (N=465) ADR No.
2, 5 mg daglig
(%)
2, 5 mg daglig
Oral ibandronic acid 2.5 mg daily (N=977) ADR No.
(N=977)
(%)
(N=975)
Placebo (N=975) ADR No.
Mave- tarmkanalen
Gastritis Diarrhoea Abdominal pain Dyspepsia Nausea Constipation Musculoskeletal disorders
Bivirkning, n (%) Bivirkning, n (%) Bivirkning, n (%)
5 (1.1) 5 (1.1) 13 (2.8) 12 (2.6) 8 (1.7) 5 (1.1)
Bivirkning, n (%)
4 (0.9) 2 (0.4) 15 (3.2) 18 (3.9) 12 (2.6) 7 (1.5)
5 (1, 1) 4 (0, 9) 7 (0, 7) 5 (1, 1) 2 (0, 4) 14 (1, 4) 13 (2, 8) 15( 3, 2) 21 (2, 1) 12 (2, 6) 18 (3, 9) 40 (4, 1) 8 (1, 7) 12 (2, 6) 18 (1, 8) 5 (1, 1) 7 (1, 5) 3 (0, 3)
7 (0.7) 14 (1.4) 21 (2.1) 40 (4.1) 18 (1.8) 3 (0.3)
Smerter i bevægeapparatet og bindevæv
Musculo-skeletal pain
5 (1, 1) 2 (0, 4) -
2 (0.4)
Artralgier Myalgier Almene symptomer og reaktioner på indgivelsesstedet
Arthralgia Myalgia General System disorders
11 (2, 3) 4 (0, 9) 4 (0, 4) 8( 1, 7) 4 (0, 9) 18 (1, 8)
4 (0.4) 18 (1.8)
4 (0, 4) 8 (0, 8)
4 (0.4) 8 (0.8)
Influenzalignende sygdom *
Influenza-like illness*
22 (4, 7) 4 (0, 9) 3 (0, 3)
22 (4.7)
Træthed Nervesystemet
Fatigue Nervous System disorders
5 (1, 1) 2 (0, 4) 3 (0, 3)
3 (0.3)
Hovedpine Hud og subkutane væv
Headache Skin disorders
5 (1, 1) 3 (0, 6) 8 (0, 8)
3 (0.6)
Udslæt MedDRA - version 7. 0
Rash MedDRA version 7.0
4 (0, 9) 3 (0, 6) 12 (1, 2)
3 (0.6)
* Der er rapporteret om forbigående, influenzalignende symptomer hos patienter, som fik intravenøs injektion af Bondenza 3 mg hver 3. måned, typisk i forbindelse med den første dosis.
* Transient, influenza-like symptoms have been reported in patients receiving intravenous injection of Bondenza 3 mg every 3 months, typically in association with the first dose.
Influenzalignende sygdom omfatter hændelser, der blev beskrevet som akut fasereaktion eller symptomer, inklusive myalgier, artralgier, feber, kulderystelser, træthed, kvalme, appetitløshed og knoglesmerter.
Influenza-like illness includes events reported as acute phase reaction or symptoms, including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, and bone pain.
Symptomerne var almindeligvis af kort varighed, af let eller moderat intensitet og forsvandt under fortsat behandling uden intervention.
Such symptoms were generally of short duration, mild or moderate in intensity, and resolved during continuing treatment without requiring remedial measures.
19 Tabel 2:
18 Table 2:
Almindelige bivirkninger (> 1/ 100, ≤ 1/ 10), bedømt af investigator til at være sandsynlig eller mulig relateret til forsøgslægemidlet, fra fase III studiet BM16550 om osteoporose efter to års behandling (kummulative data) og fra fase III anti- fraktur- studiet MF 4411 efter 3 års behandling.
Common adverse reactions (> 1/ 100, ≤ 1/ 10) in the phase III osteoporosis study BM16550 after two years of treatment (cumulative data) and in the phase III anti-fracture study MF 4411 (three- year study), that were considered by the investigator to be possibly or probably related to study medicinal product.
To- årsdata fra studie BM 16550
Two year data in study BM 16550
4411
Three year data in 4411
Systemorganklasse / bivirkning
System Organ Class/ Adverse reaction Gastrointestinal disorders
Bondenza- injektion Placeboinjektion + 3 mg hver 3. måned oral ibandronsyre
(%)
Oral ibandronsyre
(%)
Bivirkning, n (%) Bivirkning, n (%) Bivirkning, n (%)
Gastritis Diarrhoea Abdominal pain Dyspepsia Nausea Constipation Musculoskeletal disorders
Gastritis Diarré Mavesmerter Dyspepsi Kvalme Obstipation Knogler, led, muskler og bindevæv
6 (1.3) 4 (0.9) 5 (1.1) 3 (0.6) 17 (3.6) 21 (4.5) 14 (3.0) 19 (4.1) 8 (1.7) 13 (2.8) 5 (1.1) 7 (1.5)
6 (1, 3) 4 (0, 9) 7 (0, 7) 5 (1, 1) 3 (0, 6) 14 (1, 4) 17 (3, 6) 21 (4, 5) 21 (2, 1) 14 (3, 0) 19 (4, 1) 40 (4, 1) 8 (1, 7) 13 (2, 8) 18 (1, 8) 5 (1, 1) 7 (1, 5) 3 (0, 3)
7 (0.7) 14 (1.4) 21 (2.1) 40 (4.1) 18 (1.8) 3 (0.3)
5 (1, 1) 2 (0, 4) -
5 (1.1) 2 (0.4)
Artralgier Myalgier Rygsmerter Almene symptomer og reaktioner på indgivelsesstedet
Arthralgia Myalgia Back pain General System disorders
13 (2, 8) 4( 0, 9) 4 (0, 4) 8( 1, 7) 4 (0, 9) 18 (1, 8) 5 (1, 1) 1 (0, 2) 3 (0, 3)
13 (2.8) 4 (0.9) 8 (1.7) 4 (0.9) 5 (1.1) 1 (0.2)
4 (0, 4) 8 (0, 8) 2 (0, 2)
4 (0.4) 18 (1.8) 3 (0.3)
Influenzalignende sygdom *
4 (0.4) 8 (0.8) 2 (0.2)
21 (4, 5) 4 (0, 9) 3 (0, 3)
Influenza-like illness*
Træthed Nervesystemet
21 (4.5) 4 (0.9)
4 (0, 4)
2 (0.2)
Hovedpine Hud og subkutane væv
Fatigue Nervous System disorders
6( 1, 3) 3 (0, 6) 8 (0, 8)
3 (0.3)
6 (0, 6)
4 (0.4)
Udslæt MedDRA- version 8. 0
Rash MedDRA version 8.0
4 (0, 9) 4 (0, 9) 12 (1, 2)
4 (0.9) 4 (0.9)
* Der er rapporteret om forbigående, influenzalignende symptomer hos patienter som fik intravenøs injektion af Bondenza 3 mg hver 3. måned, typisk i forbindelse med den første dosis.
* Transient, influenza-like symptoms have been reported in patients receiving intravenous injection of Bondenza 3 mg every 3 months, typically in association with the first dose.
Influenzalignende sygdom omfatter hændelser der blev beskrevet som akut fasereaktion eller symptomer, inklusive myalgier, artralgier, feber, kulderystelser, træthed, kvalme, appetitløshed og knoglesmerter.
Influenza-like illness includes events reported as acute phase reaction or symptoms, including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, and bone pain.
Symptomerne var almindeligvis af kort varighed, af let eller moderat intensitet og forsvandt under fortsat behandling udenintervention.
Such symptoms were generally of short duration, mild or moderate in intensity, and resolved during continuing treatment without requiring remedial measures.
Bivirkninger, som optræder med en frekvens på ≤ 1% i studie BM 16650:
Adverse reactions occurring at a frequency of ≤ 1% in study BM16650:
Ikke almindelige (> 1/ 1000 og < 1/ 100) Knogler, led, muskler og bindevæv:
Uncommon (> 1/ 1,000 and < 1/ 100) Musculoskeletal disorders
Almene symptomer og reaktioner på indgivelsesstedet:
General disorders and administration site conditions
Asteni Reaktioner på indgivelsesstedet
Asthenia Injection site reactions
Vaskulære sygdomme:
19 Vascular Disorders
Phlebitis/ trombophlebitis
Phlebitis/ thrombophlebitis
Sjældne (≥ 1/ 10. 000 og ≤ 1/ 1000)
Rare (> 1/ 10,000 and < 1/ 1,000)
Hypersensitivitetsreaktioner Angioødem Ansigtshævelse/ ødem Urticaria
Hypersensitivity reactions Angioedema Facial swelling/ oedema Urticaria
Laboratoriefund I det pivotale 3- års studie med oral ibandronsyre 2, 5 mg daglig (MF 4411) var der ingen forskel i forhold til placebo for abnorme laboratoriefund med hensyn til lever – eller nyredysfunktion, svækket hæmatologisk system, hypocalcæmi eller hypophosphatæmi.
Laboratory test findings In the pivotal three-year study with oral ibandronic acid 2.5 mg daily (MF 4411) there was no difference compared with placebo for laboratory abnormalities indicative of hepatic or renal dysfunction, impaired haematologic system, hypocalcaemia or hypophosphataemia.
Der var tilsvarende ingen forskelle mellem grupperne i det pivotale studie med Bondenza- injektion 3 mg hver 3. måned (BM 16550).
Similarly, no differences were noted between the groups in the pivotal study with Bondenza 3 mg injection every 3 months (BM 16550).
Erfaringer efter markedsføringen Knoglenekrose i kæben er rapporteret hos patienter, der behandles med bisphosphonater.
Post-marketing Experience Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Hovedparten af rapporterne omhandler cancerpatienter, men lignende tilfælde er også set hos patienter, der behandes for osteoporose.
The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Baseret på erfaringer fra lignende præparater inden for samme klasse kan intravenøs overdosering forårsage hypocalcæmi, hypophosphatæmi og hypomagnesæmi.
Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia, hypophosphataemia, and hypomagnesaemia.
Ibandronsyre forhindrer in- vivo knogledestruktion eksperimentelt fremkaldt af ophørt gonadefunktion, retinoider, tumorer eller tumorekstrakter.
In vivo, ibandronic acid prevents bone destruction experimentally induced 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 osteoporosebehandling.
In growing rats, there was no evidence of impaired mineralisation even at doses greater than 5,000 times the dose required for osteoporosis treatment.
21 Både daglig og intermitterende (med forlængede dosisfri intervaller) langtidsadministration til rotter, hunde og aber resulterede i dannelse af ny knogle med normal kvalitet og bevaret eller øget mekanisk styrke, selv ved toksiske doser.
Both daily and intermittent (with prolonged dose-free intervals) long-term administration in rats, dogs and monkeys was associated with formation of new bone of normal quality and maintained or