natgillin/translations-raw huggingface dataset:
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.
Celoten delež bolnikov, ki so imeli neželeni učinek, to je neželeni dogodek z možno ali verjetno povezavo z zdravilom v preskušanju, je bil 22, 7% za Bonvivo 150 mg enkrat na mesec po enem letu in 25, 0% po dveh letih ter 21, 5% za ibandronsko kislino 2, 5 mg enkrat na dan po enem letu in 22, 5% po dveh letih.
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.
Preglednica 1 in preglednica 2 prikazujeta neželene dogodke, ki so se pojavili pri več kot 1% bolnikov, ki so se zdravili z Bonvivo 150 mg enkrat na mesec ali 2, 5 mg enkrat na dan v študiji BM 16549 in pri bolnikih, zdravljenih z ibandronsko kislino 2, 5 mg enkrat na dan v študiji MF 4411.
Bonviva 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
Bonviva 150 mg ibandronska enkrat na mesec kislina 2, 5 mg (n = 396) enkrat na dan (%) (n = 395) (%)
Gastro-oesophageal reflux disease
gastroezofagealna refluksna bolezen
Diarrhoea
0, 8 1, 5
2.5 1.8
0, 8 0, 6
1.4 1.0
0, 3 1, 0 0, 3
System Organ Class/ Adverse reaction
Organski sistem /
Bonviva 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
Bonviva 150 mg ibandronska
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
(n = 975) kislina 2, 5 mg
Influenza like illness* Fatigue Musculoskeletal system
neželeni učinek Mišično- skeletni sistem
3.3 0.3 1.0 0.3
enkrat na mesec kislina 2, 5 mg (n = 396) enkrat na dan (%) (n = 395) (%)
0.3 0.2 0.3 0.4
(%) enkrat na dan (n = 977) (%)
* Transient, influenza-like symptoms have been reported with Bonviva 150 mg once monthly, typically in association with the first dose.
* Prehodni, gripi podobni simptomi, o katerih so poročali pri jemanju Bonvive 150 mg enkrat na mesec, značilno v povezavi s prvim odmerkom.
Oesophagitis Diarrhoea Abdominal pain Dyspepsia Nausea Nervous system
ezofagitis diareja abdominalna bolečina dispepsija navzea Živčevje
Influenza like illness* Musculoskeletal system
bolezen, podobna gripi * 3, 3 Mišično- skeletni sistem
3.3 0.3
0, 3
0.3 0.2
0, 2
Muscle cramp Musculoskeletal pain Arthralgia
mišični krči 0, 5 mišičnoskeletna 1, 0 bolečina
0.5 1.0 1.0 0.5 1.0 0.5
1, 0 0, 5
0.1 0.4 0 0 0.4 0.4
0, 4 0
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
enkrat na mesec kislina 2, 5 mg (n = 396) enkrat na dan (%) (n = 395) (%)
Myalgia Musculoskeletal stiffness Skin disorders
mišičnoskeletna otrplost Bolezni kože
1.5 0.3 1.0 0
1, 0 0
1.8 0.8 0 0
0 0
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.
Spodaj navedeni neželeni učinki so se v študiji MF 4411 pojavili pogosteje pri ibandronski kislini 2, 5 mg enkrat na dan kot pri placebu in v študiji BM 16549 pogosteje pri zdravilu Bonviva 150 mg enkrat na mesec kot pri ibandronski kislini 2, 5 mg enkrat na dan.
Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
Osteonekroza čeljusti
7 4.9 Overdose
7 je navadno povezana z izdrtjem zoba ali lokalno okužbo (vključno z osteomielitisom) ali obojim.
No specific information is available on the treatment of over dosage with Bonviva.
Specifičnih informacij o zdravljenju prevelikega odmerjanja zdravila Bonviva ni na voljo.
Milk or antacids should be given to bind Bonviva, and any adverse reactions treated symptomatically.
Za vezavo Bonvive je treba zaužiti mleko ali antacide, neželene učinke pa zdravimo simptomatično.
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.
8 Klinična učinkovitost Pri prepoznavanju žensk s povečanim tveganjem za osteoporotični zlom moramo upoštevati neodvisne dejavnike tveganja, kot so na primer nizka mineralna kostna gostota, starost, obstoj predhodnih zlomov, družinska obremenjenost z zlomi, visoko razmerje med razgradnjo in tvorbo kosti in nizek indeks telesne mase.
8 Bonviva 150 mg once monthly
Bonviva 150 mg enkrat na mesec
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).
Mineralna kostna gostota (MKG) Bonviva 150 mg enkrat na mesec se je v povišanju MKG izkazala za najmanj enako učinkovito kakor ibandronska kislina 2, 5 mg enkrat na dan v dveletni dvojno slepi, multicentrični študiji (BM 16549) pri ženskah z osteoporozo v postmenopavzi (izhodiščna T- vrednost MKG ledvene hrbtenice pod – 2, 5 SD).
ibandronic acid Bonviva 2.5 mg daily 150 mg once (N=318) monthly (N=320)
Bonviva 150 mg enkrat na mesec
ibandronic acid Bonviva 2.5 mg daily 150 mg once (N=294) monthly (N=291)
Bonviva 150 mg enkrat na mesec
Lumbar spine L2-L4 BMD
MKG ledvene hrbtenice L2- L4
2.0 [1.7, 2.3]
6, 6 [6, 0; 7, 1]
3.1 [2.8, 3.4]
2, 0 [1, 7; 2, 3]
2.5 [2.1, 2.9]
3, 1 [2, 8; 3, 4]
4.2 [3.8, 4.5]
2, 5 [2, 1; 2, 9]
Femoral neck BMD
4, 2 [3, 8; 4, 5]
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.
Zdravilo Bonviva 150 mg enkrat na mesec se je izkazalo za boljše kakor ibandronska kislina 2, 5 mg enkrat na dan v povišanju MKG ledvene hrbtenice v prospektivno načrtovani analizi po enem letu, p = 0, 002, in dveh letih, p < 0, 001.
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.
Po enem letu (primarna analiza) se je 91, 3% (p = 0, 005) bolnikom, ki so prejemali Bonvivo 150 mg enkrat na mesec, MKG lumbalne hrbtenice povišala ali ostala enaka izhodiščni vrednosti (bolniki, odzivni na povišanje MKG) v primerjavi s 84, 0% bolnikov, ki so prejemali ibandronsko kislino 2, 5 mg na dan.
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.
Po dveh letih je bilo odzivnih 93, 5% bolnikov (p = 0, 004), ki so prejemali Bonvivo 150 mg enkrat na mesec in 86, 4% bolnikov, ki so prejemali ibandronsko kislino 2, 5 mg enkrat na dan.
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.
MKG kolka se je po enem letu povišala ali ostala enaka izhodiščni vrednosti pri 90, 0% (p < 0, 001) bolnikov, ki so prejemali 150 mg enkrat na mesec in 76, 7% bolnikov, ki so prejemali ibandronsko kislino 2, 5 mg na dan.
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.
Po dveh letih se je MKG kolka povišala ali ostala enaka izhodiščni vrednosti pri 93, 4% bolnikov (p < 0, 001), ki so prejemali Bonvivo 150 mg enkrat na mesec in 78, 4% bolnikov, ki so prejemali ibandronsko kislino 2, 5 mg enkrat na dan.
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.
Po dveh letih je 87, 1% (p
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.
9 < 0, 001) bolnikov, ki so prejemali 150 mg enkrat na mesec in 70, 5% bolnikov, ki so prejemali 2, 5 mg na dan, zadostilo kriterijem za odzivnost.
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.
Po enem letu (primarna analiza) je bila mediana relativne spremembe od izhodiščne vrednosti – 76% za Bonvivo 150 mg enkrat na mesec in – 67% za ibandronsko kislino 2, 5 mg enkrat na dan.
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).
Po enem letu je bilo odzivnih 83, 5% bolnikov (p = 0, 006), ki so prejemali Bonvivo 150 mg enkrat na mesec in 73, 9% bolnikov, ki so jemali ibandronsko kislino 2, 5 mg enkrat na dan, odzivnost so definirali kot ≥ 50% zmanjšanje od izhodišča.
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.
Glede na rezultate študije BM 16549 pričakujemo, da je Bonviva 150 mg enkrat na mesec najmanj enako učinkovita v preprečevanju zlomov kakor ibandronska kislina 2, 5 mg enkrat na dan.
Relative Risk Reduction New morphometric vertebral fractures
placebo (n = 974)
Placebo (N=974)
ibandronska kislina 2, 5 mg enkrat na dan (n = 977)
Incidence of clinical vertebral fracture BMD – mean change relative to baseline lumbar spine at year 3
MKG – povprečna sprememba glede 1, 26% (0, 8; 1, 7) na izhodiščno vrednost za ledveno hrbtenico po 3 letih
5.33% (3.73, 6.92) 1.26% (0.8, 1.7)
placebo (n = 974)
2.75% (1.61, 3.89) 6.54% (6.1, 7.0)
ibandronska kislina 2, 5 mg enkrat na dan (n = 977)
BMD – mean change relative to baseline total hip at year 3
na izhodiščno vrednost kolka po 3 letih
-0.69% (-1.0, -0.4)
(– 1, 0; – 0, 4)
Relative Risk Reduction New morphometric vertebral fractures
placebo (n = 587)
Placebo (N=587)
ibandronska kislina 2, 5 mg enkrat na dan (n = 575)
ibandronic acid 2.5 mg daily (N=575) 59% (34.5, 74.3)
59% (34, 5; 74, 3)
BMD – mean change relative to baseline lumbar spine at year 3
MKG – povprečna sprememba glede 1, 13% (0, 6; 1, 7) na izhodiščno vrednost za ledveno hrbtenico po 3 letih
BMD – mean change relative to baseline total hip at year 3
MKG – povprečna sprememba glede – 0, 70% (– 1, 1; – 0, 2) na izhodiščno vrednost kolka po 3 letih
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.
Vezava na plazemske beljakovine pri ljudeh je približno 85 - do 87 -% (določeno in vitro pri terapevtskih koncentracijah), zato so medsebojna delovanja med zdravili zaradi izpodrivanja malo verjetna.
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.
12 Bolniki s hudo motnjo ledvičnega delovanja (CLcr manjši kot 30 ml/ min), ki so prejemali peroralno 10 mg ibandronske kisline na dan 21 dni, so imeli 2 - do 3- krat višje plazemske koncentracije kot osebe z normalno ledvično funkcijo.
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.
Po intravenskem dajanju odmerka 0, 5 mg se je pri bolnikih s hudo ledvično okvaro celokupni očistek zmanjšal za 67%, ledvični očistek za 77%, neledvični očistek pa za 50%.
Due to the limited clinical experience, Bonviva is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Zaradi omejenih kliničnih izkušenj jemanje Bonvive pri bolnikih s hudo okvaro ledvic ni priporočljivo (glejte poglavje 4. 2 in poglavje 4. 4).
Paediatric Population There are no data on the use of Bonviva in these age groups.
Otroci in mladostniki O uporabi Bonvive pri tej skupini bolnikov ni podatkov.
There was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats at an extrapolated exposure of at least 35 times above human exposure.
Pri ekstrapolaciji izpostavljenosti, ki je 35- krat presegala izpostavljenost pri človeku, na razvoj F1 potomcev podgan niso opazili škodljivih vplivov.
Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Neželeni učinki ibandronske kisline v študijah vplivov na sposobnost razmnoževanja pri podganah so bili pričakovano značilni za to vrsto zdravil (bisfosfonati).
Tablet coat Hypromellose Titanium dioxide E171 Talc Macrogol 6,000
13 Obloga tablete hipromeloza titanov dioksid E171 smukec makrogol 6000
Bonviva 150 mg film-coated tablets are supplied in blisters (PVC/ PVDC) containing 1 or 3 tablets.
Filmsko obložene tablete Bonviva 150 mg so na voljo v (PVC/ PVDC) pretisnih omotih z 1 ali 3 tabletami.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. eu. int /.
Bonviva 3 mg solution for injection
Bonviva 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Solution for injection.
Raztopina za injiciranje, napolnjena injekcijska brizga.
Posology:
Za intravensko uporabo.
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.
Bolniki z ledvično okvaro Pri bolnikih z blago do zmerno ledvično okvaro, ki imajo serumski kreatinin enak ali manjši kot 200 µmol/ l (2, 3 mg/ dl) ali očistek kreatinina (izmerjen ali ocenjen) enak ali večji kot 30 ml/ min, prilagajanje odmerkov ni potrebno.
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)
Uporaba Bonvive v obliki injekcije pri bolnikih s serumskim kreatininom nad 200 µmol/ l (2, 3 mg/ dl) ali s kreatininskim očistkom (izmerjenim ali ocenjenim) pod 30 ml/ min zaradi omejenih kliničnih podatkov iz študij, ki so vključevale take bolnike, ni priporočljiva (glejte poglavje 4. 4 in poglavje 5. 2).
15 Paediatric Population There is no relevant use of Bonviva in children, and Bonviva was not studied in the paediatric population.
15 Otroci in mladostniki Izkušenj pri otrocih ni.
Care must be taken not to administer Bonviva injection via intra-arterial or paravenous administration as this could lead to tissue damage.
Bonviva lahko, tako kot drugi bisfosfonati, ki jih dajemo intravensko, povzroči prehodno zmanjšanje serumskih vrednosti kalcija.
Existing hypocalcaemia must be corrected before starting Bonviva injection therapy.
Hipokalcemijo je treba popraviti pred začetkom zdravljenja z Bonvivo v obliki injekcije.
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.
Bolnike, ki imajo sočasno še druge bolezni ali jemljejo zdravila z možnimi neželenimi učinki za ledvice, je treba med zdravljenjem redno spremljati v skladu z dobro zdravniško prakso.
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).
Zaradi omejenih kliničnih izkušenj Bonvive v obliki injekcije ne priporočamo bolnikom, ki imajo serumski kreatinin nad 200 µmol/ l (2, 3 mg/ dl) ali kreatininski očistek, manjši kot 30 ml/ min (glejte poglavje 4. 2 in poglavje 5. 2).
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.
Pri bolnikih z rakom, ki so prejemali zdravljenje, ki je prvenstveno vključevalo bisfosfonate, dane intravensko, so poročali o osteonekrozi čeljusti, po navadi povezani z izdrtjem zoba ali lokalno okužbo (vključno z osteomielitisom) ali obojim.
16 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (oestrogen).
16 Farmakokinetične študije medsebojnega delovanja pri ženskah v postmenopavzi so pokazale, da s tamoksifenom ali hormonskim nadomestnim zdravljenjem (estrogenom) ne prihaja do medsebojnega delovanja.
Pregnancy There are no adequate data from the use of ibandronic acid in pregnant women.
Ni zadostnih podatkov o uporabi ibandronske kisline pri nosečnicah.
Bonviva should not be used during pregnancy.
Zdravilo Bonviva se med nosečnostjo ne sme uporabljati.
Lactation It is not known whether ibandronic acid is excreted in human milk.
Ni znano, ali se ibandronska kislina izloča v materino mleko.
Bonviva should not be used during lactation.
Zdravilo Bonviva se med dojenjem ne sme uporabljati.
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.
V ključni dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16550), je bila celokupna varnost zdravila Bonviva 3 mg v obliki intravenske injekcije, dane vsake 3 mesece, in ibandronske kisline 2, 5 mg, dane peroralno enkrat na dan, podobna.
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.
Celoten delež bolnikov, ki so imeli neželeni učinek, je bil 26, 0% za zdravilo Bonviva 3 mg v obliki injekcije, dane vsake 3 mesece, po enem letu in 28, 6% po dveh letih; 20, 4% za 2, 5 mg ibandronske kisline, dane peroralno enkrat na dan, po enem letu in 22, 6% po dveh letih.
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.
Preglednici 1 in 2 prikazujeta neželene dogodke po enem in dveh letih zdravljenja iz ključne faze III preskušanja BM 16550, o katerih so poročali, da so možno ali verjetno povezani z zdravilom v preskušanju pri več kot 1% bolnikov, ki so se zdravili z intravensko injekcijo Bonvive 3 mg vsake 3 mesece ali intravensko injekcijo placeba z 2, 5 mg ibandronske kisline, dane peroralno enkrat na dan.
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.
Neželeni učinki, o katerih so poročali enako pogosto ali redkeje pri bolnikih, zdravljenih s 3- mg injekcijami Bonvive kakor pri peroralnem odmerjanju, niso upoštevani.
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).
Preglednici 1 in 2 prikazujeta tudi neželene učinke pri bolnikih, ki so se v okviru študije, v kateri so proučevali učinkovitost proti zlomom (MF 4411), 3 leta zdravili z ibandronsko kislino 2, 5 mg na dan peroralno.
For both studies, adverse reactions are listed which occurred with a higher incidence in ibandronic acid -treated
Za obe študiji so navedeni neželeni učinki, ki so se pojavili z večjo incidenco pri bolnikih, zdravljenih z ibandronsko kislino, kakor pri bolnikih, zdravljenih s placebom v študiji MF 4411.
Table 1:
17 Preglednica 1.
study MF
Bonviva 3 mg v
Bonviva injection 3 mg every 3 months (N=469) ADR No.
ibandronska
Placebo injection + oral ibandronic acid 2.5 mg daily (N=465) ADR No.
(n = 469) število neželenih učinkov (%)
(%)
peroralno (n = 977) število
Oral ibandronic acid 2.5 mg daily (N=977) ADR No.
število neželenih učinkov (%)
(%)
učinkov (%)
Placebo (N=975) ADR No.
učinkov (%)
(%)
2 (0, 4)
5 (0.5) 10 (1.0) 28 (2.9) 26 (2.7) 22 (2.3) 9 (0.9)
28 26 22 9
Arthralgia Myalgia General System disorders
artralgija
4 (0.4) 8 (0.8)
4 (0, 4)
Influenza-like illness*
mialgija Splošne težave
* 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.
* Prehodni, gripi podobni simptomi, o katerih so poročali pri uporabi intravenske injekcije zdravila Bonviva 3 mg, dani vsake 3 mesece, značilno v povezavi s prvim odmerkom.
18 Table 2:
18 Preglednica 2.
16550
Dveletni podatki iz študije BM 16550
(%)
3 (0, 6)
6 (1.3) 5 (1.1) 17 (3.6) 14 (3.0) 8 (1.7) 5 (1.1)
17 (3, 6) 14 (3, 0) 8 (1, 7) 5 (1, 1)
4 (0.9) 3 (0.6) 21 (4.5) 19 (4.1) 13 (2.8) 7 (1.5)
21 (4, 5) 19 (4, 1) 13 (2, 8) 7 (1, 5)
Arthralgia Myalgia Back pain General System disorders
artralgija
4 (0.4) 8 (0.8) 2 (0.2)
4 (0, 4)
* 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.
* Prehodni, gripi podobni simptomi, o katerih so poročali pri uporabi intravenske injekcije Bonvive 3 mg, dani vsake 3 mesece, značilno v povezavi s prvim odmerkom.
19 General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije:
Vascular Disorders
Žilne bolezni:
Rare (> 1/ 10,000 and < 1/ 1,000)
19 Redki (> 1/ 10. 000 in < 1/ 1. 000) Bolezni imunskega sistema:
Similarly, no differences were noted between the groups in the pivotal study with Bonviva 3 mg injection every 3 months (BM 16550).
Tudi v ključni študiji s 3- mg injekcijo Bonvive, dano vsake 3 mesece (BM 16550) razlik med skupinama niso opazili.
No specific information is available on the treatment of overdosage with Bonviva.
Specifičnih informacij o zdravljenju prevelikega odmerjanja Bonvive ni na voljo.
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.
20 pa je bila ohranjena ali celo povečana tudi pri toksičnih odmerkih.
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.
Intravenske injekcije Bonvive so zmanjšale vrednosti serumskih C- telopeptidov alfa verige kolagena tipa I (CTX) v 3 do 7 dneh po začetku zdravljenja in vrednosti osteokalcina v 3 mesecih.