natgillin/translations-raw huggingface dataset:
Behandling med Bonviva kan være forbundet med knoglevævsdød i kæben.
Bonviva treatment may be linked to osteonecrosis of the jaw (collapse of bone tissue in the jaw).
Derfor skal forsigtighed udvises hos patienter, der også modtager tandbehandling
Care is needed in patients who receive the medicine and are having dental treatment.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Bonviva opvejer risiciene til behandling og forebyggelse af osteoporose hos kvinder efter overgangsalderen med forhøjet risiko for brud.
The Committee for Medicinal Products for Human Use (CHMP) decided that Bonviva’ s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Bonviva.
The Committee recommended that Bonviva be given marketing authorisation.
Andre oplysninger om Bonviva:
Other information about Bonviva:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bonviva til Roche Registration Limited den 23. februar 2004.
The European Commission granted a marketing authorisation valid throughout the European Union for Bonviva to Roche Registration Limited on 23 February 2004.
Den fuldstændige EPAR for Bonviva findes her.
The full EPAR for Bonviva can be found here.
Blister (PVC/ PVDC) Blister (PVC/ PVDC)
Blister (PVC/ PVDC) Blister (PVC/ PVDC)
EU/ 1/ 03/ 265/ 005 EU/ 1/ 03/ 265/ 006
EU/ 1/ 03/ 265/ 005
Bonviva Bonviva
Bonviva
Intravenøs Intravenøs
EU/ 1/ 03/ 265/ 006 Bonviva
Fyldt injektionssprøjte (glas) Fyldt injektionssprøjte (glas) 3
3 mg
3 ml (1 mg/ ml) ml (1 mg/ ml)
3 ml (1 mg/ ml)
Bonviva skal indtages efter natlig faste (mindst 6 timer) og 1 time før dagens første indtagelse af mad - eller drikkevarer (andet end vand) (se pkt 4. 5) eller andet oralt lægemiddel eller kosttilskud (herunder calcium).
Bonviva should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium).
Hvis patienterne opdager, at de har glemt at tage en Bonviva- tablet 150 mg, skal de tage den næste morgen forudsat, at der er mindst 7 dage til næste dosis.
In case a dose is missed, patients should be instructed to take one Bonviva 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days.
På grund af manglende klinisk erfaring kan Bonviva ikke anbefales til patienter, hvor kreatininclearance er lavere end 30 ml/ min (se pkt 4. 4 og 5. 2).
Bonviva is not recommended for patients with a creatinine clearance below 30 ml/ min due to limited clinical experience (see section 4.4 and section 5.2).
Pædiatrisk population Anvendelse af Bonviva er ikke relevant hos børn, og der er ingen erfaring med behandling af børn.
Paediatric Population There is no relevant use of Bonviva in children, and Bonviva was not studied in the paediatric population.
Tabletterne skal synkes hele med et glas postevand (180 til 240 ml), mens patienten sidder ned eller står op.
Tablets should be swallowed whole with a glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position.
Bonviva må kun indtages sammen med postevand.
Plain water is the only drink that should be taken with Bonviva.
Lægen skal være opmærksom på ethvert tegn eller symptom på esophagus reaktion under behandlingen, og patienten skal instrueres i at standse behandlingen med Bonviva og søge læge, hvis der udvikles symptomer på spiserørsirritation som f. eks. nyopstået eller forværret dysphagi, synke - smerter, retrosternal smerte eller halsbrand.
Physicians should be alert to signs or symptoms signalling a possible oesophageal reaction during therapy, and patients should be instructed to discontinue Bonviva and seek medical attention if they develop symptoms of oesophageal irritation such as new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn.
Hypocalcæmi Eksisterende hypocalcæmi bør behandles, før behandling med Bonviva initieres.
Hypocalcaemia Existing hypocalcaemia must be corrected before starting Bonviva therapy.
Nedsat nyrefunktion På grund af begrænset klinisk erfaring, kan Bonviva ikke anbefales til patienter med kreatinin - clearance lavere end 30 ml/ min (se pkt 5. 2).
Renal impairment Due to limited clinical experience, Bonviva is not recommended for patients with a creatinine clearance below 30 ml/ min (see section 5.2).
Dette er i overensstemmelse med resultater fra dyreforsøg.
In particular, products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk, are likely to interfere with absorption of Bonviva, which is consistent with findings in animal studies.
4. 2).
Therefore, patients should fast overnight (at least 6 hours) before taking Bonviva and continue fasting for 1 hour following intake of Bonviva (see section 4.2).
Calciumtilskud, antacida samt visse orale lægemidler indeholdende multivalente kationer (som f. eks. aluminium, magnesium, jern), vil sandsynligvis påvirke absorptionen af Bonviva.
Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Bonviva.
Incidensen af øvre gastrointestinale hændelser var den samme hos patienter, som blev behandlet med 150 mg Bonviva én gang om måneden, som hos patienter, som blev behandlet med 2, 5 mg ibandronsyre daglig.
Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bonviva 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Da øgningen ligger inden for den normale variabilitet for biotilgængeligheden af ibandronsyre, anses dosisjustering ikke for nødvendig, når Bonviva administreres sammen med H2- antagonister eller andre aktive substanser, som øger gastrisk pH.
However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Bonviva is administered with H2- antagonists or other active substances which increase gastric pH.
Bonviva bør ikke anvendes under amning.
Bonviva should not be used during lactation.
I et to- års studie hos postmenopausale kvinder med osteoporose (BM 16549) var sikkerheden af Bonviva 150 mg én gang om måneden den samme som for ibandronsyre 2, 5 mg daglig.
In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Bonviva 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
Andelen af patienter med bivirkninger var 22, 7% og 25, 0% for Bonviva 150 mg én gang om måneden og 21, 5% og 22, 5% for ibandronsyre 2, 5 mg daglig efter henholdsvis et og to år.
The overall proportion of patients who experienced an adverse reaction, was 22.7% and 25.0% for Bonviva 150 mg once monthly and 21.5% and 22.5% for ibandronic acid 2.5 mg daily after one and two years, respectively.
Af tabel 1 og 2 fremgår de bivirkninger i studiet BM 16549, som forekom hos mere end 1% af de patienter, som fik Bonviva, enten 150 mg én gang om måneden eller 2, 5 mg daglig, og hos patienter, som fik ibandronsyre 2, 5 mg daglig i MF 4411.
Table 1 and table 2 list adverse reactions occurring in more than 1% of patients treated with Bonviva 150 mg monthly or 2.5 mg daily in study BM 16549 and in patients treated with ibandronic acid 2.5 mg daily in study MF 4411.
Almindelige bivirkninger (> 1/ 100, ≤ 1/ 10) i fase III- osteoporose- studier som af investigator blev betragtet som muligt eller sandsynligt relateret til behandlingen - Data fra et- års studie BM 16549 og tre- års data fra placebokontrolleret frakturstudie MF 4411
Common adverse reactions (> 1/ 100, ≤ 1/ 10) in phase III osteoporosis studies that were considered by the investigator to be possibly or probably related to treatment - One year data from study BM 16549 and three year data from placebo-controlled fracture study MF 4411
Bonviva 150 mg ibandronsyre én gang om 2, 5 mg daglig måneden (N=395) (N=396) (%) (%)
Bonviva 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
* Der er rapporteret om forbigående influenzalignende symptomer efter indtagelse af Bonviva 150 mg én gang om måneden, typisk i forbindelse med første dosis.
* Transient, influenza-like symptoms have been reported with Bonviva 150 mg once monthly, typically in association with the first dose.
To- års kumulative data fra studie BM 16549
Two year cumulative data in study BM 16549
Esophagitis Diarré Mavesmerter Dyspepsi Kvalme Nervesystemet
Oesophagitis Diarrhoea Abdominal pain Dyspepsia Nausea Nervous system
0 1, 0 2, 5 2, 0 4, 0 3, 0 4, 0 6, 3 3, 0 3, 5
0 1.0 2.5 2.0 4.0 3.0 4.0 6.3 3.0 3.5
0, 5 0, 4 1, 4 1, 0 2, 1 2, 9 4, 0 2, 7 1, 8 2, 3
0.5 0.4 1.4 1.0 2.1 2.9 4.0 2.7 1.8 2.3
0, 8 1, 5
0.3 0.2
0, 8 0, 6
0.1 0.4 0 0 0.4 0.4
Organklasse / bivirkninger Almene symptomer og reaktioner på indgivelsesstedet
System Organ Class/ Adverse reaction
0, 5 1, 0 1, 0 0, 5
1.5 0.3 1.0 0
Følgende liste viser de bivirkninger, rapporteret fra studie MF 4411, som optrådte hyppigere med ibandronsyre 2, 5 mg daglig end med placebo og fra studie BM 16549, som optrådte hyppigere med Bonviva 150 mg én gang om måneden end med ibandronsyre 2, 5 mg daglig.
The following list provides information on adverse reactions reported in study MF 4411 occurring more frequently with ibandronic acid 2.5 mg daily than with placebo and study BM 16549 occurring more frequently with Bonviva 150 mg once monthly than with ibandronic acid 2.5 mg daily.
Mave- tarmkanalen:
Immune System Disorders:
Der er ingen tilgængelig specifik information vedrørende behandling af overdosering med Bonviva.
No specific information is available on the treatment of over dosage with Bonviva.
Bonviva 150 mg én gang om måneden
8 Bonviva 150 mg once monthly
Knoglemineraltæthed (BMD) I et to- års, dobbeltblindt multicenterstudie (BM 16549) var Bonviva 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).
Bone mineral density (BMD) Bonviva 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).
ibandronsyre Bonviva 150 mg 2, 5 mg daglig én gang om (N=318) måneden (N=320)
ibandronic acid Bonviva 2.5 mg daily 150 mg once (N=318) monthly (N=320)
ibandronsyre Bonviva 150 mg 2, 5 mg daglig én gang om (N=294) måneden (N=291)
ibandronic acid Bonviva 2.5 mg daily 150 mg once (N=294) monthly (N=291)
Desuden blev det i en prospektiv planlagt analyse vist, at Bonviva 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, Bonviva 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 Bonviva 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 Bonviva 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 Bonviva 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 Bonviva 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 Bonviva 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 Bonviva 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 Bonviva 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 Bonviva 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Efter et år (primær analyse) var de mediane, relative ændringer fra baseline - 76% for gruppen, som fik Bonviva 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 Bonviva 150 mg once monthly and -67% for ibandronic acid 2.5 mg daily.
Efter et år var 83, 5% (p=0, 006) af patienterne, som fik Bonviva 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).
9 At one year, 83.5% (p= 0.006) of patients receiving Bonviva 150 mg once monthly and 73.9% of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease ≥ 50% from baseline).
På grundlag af resultaterne fra studie BM 16549 forventes Bonviva 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, Bonviva 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily.
vertebrale frakturer
4.68% (3.2,6.2)
ibandronsyre 2, 5 mg daglig
49% (14.03, 69.49)
(9, 53; 15, 55)
5.36% (3.31, 7.41)
(9, 49; 71, 91) Hyppighed af kliniske vertebrale
Relative risk reduction of clinical vertebral fracture
3, 57%
50% (9.49, 71.91)
frakturer BMD – gennemsnitlig ændring i
Incidence of clinical vertebral fracture
Daglig behandling med 2, 5 mg Bonviva 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.
På grund af begrænsede erfaringer, kan Bonviva ikke anbefales til patienter med svært nedsat nyrefunktion, (se pkt 4. 2 og pkt 4. 4).
Due to the limited clinical experience, Bonviva is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Pædiatrisk population Der findes ikke data vedrørende brugen af Bonviva til disse aldersgrupper.
Paediatric Population There are no data on the use of Bonviva in these age groups.
Bonviva 150 mg filmovertrukne tabletter leveres i blisterpakninger (PVC/ PVDC) indeholdende 1 eller 3 tabletter.
Bonviva 150 mg film-coated tablets are supplied in blisters (PVC/ PVDC) containing 1 or 3 tablets.
4. 4 og 5. 2).
Bonviva 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)
Pædiatrisk population Anvendelse af Bonviva er ikke relevant hos børn og der er ingen erfaring med behandling af børn.
15 Paediatric Population There is no relevant use of Bonviva in children, and Bonviva was not studied in the paediatric population.
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 Bonviva injection via intra-arterial or paravenous administration as this could lead to tissue damage.
Hypercalæmi Bonviva kan, ligesom andre intravenøst administrerede bisphosphonater, forårsage et forbigående fald i værdierne for serum calcium.
Hypocalcaemia Bonviva, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Eksisterende hypocalcæmi bør behandles, før i. v. behandling med Bonviva initieres.
Existing hypocalcaemia must be corrected before starting Bonviva injection therapy.
Andre forstyrrelser i knogle – og mineralstofskiftet bør ligeledes behandles effektivt før behandlingen med Bonviva- injektioner påbegyndes.
Other disturbances of bone and mineral metabolism should also be effectively treated before starting Bonviva injection therapy.
4. 2 og 5. 2).
Due to limited clinical experience, Bonviva 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).
Metaboliske interaktioner anses ikke for sandsynlige, da ibandronsyre ikke hæmmer de vigtige humane lever P450 isoenzymer og inducerer ikke levercytokrom P450 systemet hos rotter.
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.
Bonviva bør ikke anvendes under amning
Bonviva should not be used during lactation.
I det pivotale to- års studie hos postmenopausale kvinder med osteoporose (BM 16550) var sikkerheden af i. v. behandling med Bonviva 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 Bonviva 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% Bonviva 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 Bonviva 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.
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 Bonviva 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 Bonviva 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 Bonviva 3 mg, med en hyppighed svarende til eller mindre end hos oralt behandlede patienter er ikke inkluderet.
Adverse reactions reported in patients treated with Bonviva 3 mg injection at a frequency equal to or less than that in orally treated patients, are not included.
(N=465)
(%)
2 (0, 4)
(%)
Mavesmerter Dyspepsi Kvalme Obstipation Knogler, led, muskler og bindevæv
Gastritis Diarrhoea Abdominal pain Dyspepsia Nausea Constipation Musculoskeletal disorders
13 (2, 8) 12 (2, 6) 8 (1, 7) 5 (1, 1)
5 (1.1) 5 (1.1) 13 (2.8) 12 (2.6) 8 (1.7) 5 (1.1)
15( 3, 2) 18 (3, 9) 12 (2, 6) 7 (1, 5)
4 (0.9) 2 (0.4) 15 (3.2) 18 (3.9) 12 (2.6) 7 (1.5)
21 (2, 1) 40 (4, 1) 18 (1, 8) 3 (0, 3)
7 (0.7) 14 (1.4) 21 (2.1) 40 (4.1) 18 (1.8) 3 (0.3)
28 (2, 9) 26 (2, 7) 22 (2, 3) 9 (0, 9)
5 (0.5) 10 (1.0) 28 (2.9) 26 (2.7) 22 (2.3) 9 (0.9)
11 (2, 3) 8( 1, 7)
11 (2.3) 8 (1.7)
4 (0, 4) 18 (1, 8)
4 (0.4) 18 (1.8)
* Der er rapporteret om forbigående, influenzalignende symptomer hos patienter, som fik intravenøs injektion af Bonviva 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 Bonviva 3 mg every 3 months, typically in association with the first dose.
To- årsdata fra studie BM 16550
Two year data in study BM
Tre- årsdata fra studie MF
16550
Bonviva- injektion Placeboinjektion + 3 mg hver 3. måned oral ibandronsyre
(%)
2, 5 mg daglig
6 (1.3) 5 (1.1) 17 (3.6) 14 (3.0) 8 (1.7) 5 (1.1)
2, 5 mg daglig
4 (0.9) 3 (0.6) 21 (4.5) 19 (4.1) 13 (2.8) 7 (1.5)
(N=469) (N=465)
Musculo-skeletal pain
(N=977)
5 (1.1)
(N=975)
2 (0.4)
Mave- tarmkanalen
Arthralgia Myalgia Back pain General System disorders
Bivirkning, n (%) Bivirkning, n (%) Bivirkning, n (%)
13 (2.8) 8 (1.7) 5 (1.1)
Bivirkning, n (%)
4 (0.9) 4 (0.9) 1 (0.2)
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)
4 (0.4) 18 (1.8) 3 (0.3)
5 (0, 5) 10 (1, 0) 28 (2, 9) 26 (2, 7) 22 (2, 3) 9 (0, 9)
4 (0.4) 8 (0.8) 2 (0.2)
Smerter i bevægeapparatet og bindevæv
Influenza-like illness*
5 (1, 1) 2 (0, 4) -
21 (4.5)
-
4 (0.9)
Artralgier Myalgier Rygsmerter Almene symptomer og reaktioner på indgivelsesstedet
3 (0.3)
4 (0, 4) 8 (0, 8) 2 (0, 2)
2 (0.2)
Influenzalignende sygdom *
Fatigue Nervous System disorders
21 (4, 5) 4 (0, 9) 3 (0, 3)
5 (1.1)
2 (0, 2)
2 (0.4)
6( 1, 3) 3 (0, 6) 8 (0, 8)
3 (0.6)
4 (0, 9) 4 (0, 9) 12 (1, 2)
12 (1.2)
* Der er rapporteret om forbigående, influenzalignende symptomer hos patienter som fik intravenøs injektion af Bonviva 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 Bonviva 3 mg every 3 months, typically in association with the first dose.
Almene symptomer og reaktioner på indgivelsesstedet:
19 General disorders and administration site conditions
Vaskulære sygdomme:
Vascular Disorders
Der var tilsvarende ingen forskelle mellem grupperne i det pivotale studie med Bonviva- injektion 3 mg hver 3. måned (BM 16550).
Similarly, no differences were noted between the groups in the pivotal study with Bonviva 3 mg injection every 3 months (BM 16550).
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.
20 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 increased mechanical strength even at doses in the toxic range.
Intravenøse injektioner med Bonviva nedsatte koncentrationen af serum- C- telopeptid af alfakæden af type I kollagen (CTX) indenfor 3 - 7 dage efter påbegyndelsen af behandlingen og af osteocalcin indenfor 3 måneder.
Bonviva intravenous injection decreased levels of serum C-telopeptide of the alpha chain of Type I collagen (CTX) within 3 - 7 days of starting treatment and decreased levels of osteocalcin within 3 months.
Der blev også set et forventet fald i knogleomsætning, normal knoglekvalitet og fravær af mineraliseringsdefekt efter 2 års behandling med i. v behandling med Bonviva 3 mg.
An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with Bonviva 3 mg injection.
Bonviva 3 mg injektion hver 3 måned
Bonviva 3 mg injection every 3 months