qanastek/EMEA-V3 huggingface dataset:
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 Bondenza 3 mg injection.
Dehru ukoll tnaqqis mistenni fil- bidla ta ’ l- għadam, kwalità normali ta ’ l- għadam u nuqqas ta ’ difetti fil - mineralizzazjoni wara sentejn ta ’ kura b’ injezzjoni ta ’ Bondenza 3 mg.
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.
Effikaċja klinika Fatturi ta ’ riskju indipendenti, per eżempju, BMD baxx, eta ’, l- eżistenza ta ’ ksur minn qabel, passat ta ’ ksur fil- familja, bidla għolja fl- għadam u indiċi tal- massa tal- ġisem baxx, għandhom jiġu kkunsidrati sabiex jiġu identifikati nisa f’ riskju akbar ta ’ ksur osteoporotiku.
Bondenza 3 mg injection every 3 months
Injezzjoni ta ’ Bondenza 3 mg kull tliet xhur
Bone mineral density (BMD)
Densità tal- minerali tal- għadam (BMD)
Bondenza 3 mg intravenous injection, administered every 3 months, was shown to be at least as effective as oral ibandronic acid 2.5 mg daily in a 2-year, randomised, double-blind, multicentre, non- inferiority study (BM16550) of postmenopausal women (1386 women aged 55 - 80) with osteoporosis (lumbar spine BMD T-score below -2.5 SD at baseline).
Fi studju ta ’ ħafna ċentri, double- blind, randomized, mhux ta ’ inferjorità ta ’ sentejn (BM 16550) ta ’ nisa wara l- menopawża (1386 mara b’ età ta ’ 55 - 80) b’ osteoporożi (punteġġ T tal- BMD tas- sinsla lumbari taħt - 2. 5 SD fil- linja bażi), injezzjoni ġol- vini ta ’ Bondenza 3 mg mogħtija kull 3 xhur, intweriet li kienet mill- inqas effettiva daqs ibandronic acid 2. 5 mg kuljum.
This was demonstrated in both the primary analysis at one year and in the confirmatory analysis at two years endpoint (Table 3).
Dan intwera kemm fl - analiżi primarja wara sena kif ukoll fl- analiżi ta ’ konferma ma ’ tmiem is- sentejn (Tabella 3).
The primary analysis of data from study BM16550 at one year and the confirmatory analysis at 2 years demonstrated the non-inferiority of 3 mg every 3 months injection dosing regimen compared to 2.5 mg oral daily dosing regimen, in terms of mean increases in BMD at lumbar spine, total hip, femoral neck and trochanter (Table 3).
Analiżi primarja ta ’ tagħrif mill- istudju BM16550 wara sena u l- analiżi ta ’ konferma wara sentejn urew li kors ta ’ dożaġġ ta ’ injezzjoni ta ’ 3 mg kull 3 xhur mhux inferjuri meta mqabbel ma ’ kors ta ’ dożaġġ ta ’ 2. 5 mg orali kuljum, f’ termini ta ’ żieda medja fil- BMD tas- sinsla lumbari, tal- ġenbejn totali, tal- għonq tal- wirk u tat- trokanter (Tabella 3).
21 Table 3:
21 Tabella 3:
One year data in study BM 16550
Bidla relattiva medja mil- linja bażi fil- BMD tas- sinsla lumbari, tal- ġembejn totali, ta ’ l - għonq tal- wirk u tat- trokanter wara sena (analiżi primarja), u sentejn ta ’ kura (Popolazzjoni Per - Protokoll) fl- istudju BM 16550.
Two year data in study BM 16550
Tagħrif kumulattiv ta ’ wara Tagħrif ta ’ wara sena fl- istudju sentejn fl- istudju BM 16550 BM 16550 Bidliet relattivi medji mil -
ibandronic acid
ibandronic acid
ibandronic acid Bondenza ibandronic
Injezzjoni ta ’ ibandronic acid
Bondenza
Injezzjoni
from baseline% [95% CI]
linja bażi% [95% CI]
2.5 mg daily (N=377)
2. 5 mg kuljum
3 mg injection every 3 months (N=365)
Bondenza 3 mg 2. 5 mg kuljum
3 mg injection every 3 months (N=334)
3 mg kull 3 (N=365) xhur (N=334)
3.8 [3.4, 4.2]
3. 8 [3. 4, 4. 2]
4.8 [4.5, 5.2]
4. 8 [4. 5, 5. 2]
4.8 [4.3, 5.4]
4. 8 [4. 3, 5. 4]
6.3 [5.7, 6.8]
6. 3 [5. 7, 6. 8]
1.8 [1.5, 2.1]
1. 8 [1. 5, 2. 1]
2.4 [2.0, 2.7]
2. 4 [2. 0, 2. 7]
2.2 [1.8, 2.6]
2. 2 [1. 8, 2. 6]
3.1 [2.6, 3.6]
3. 1 [2. 6, 3. 6]
1.6 [1.2, 2.0]
1. 6 [1. 2, 2. 0]
2.3 [1.9, 2.7]
2. 3 [1. 9, 2. 7]
2.2 [1.8, 2.7]
2. 2 [1. 8, 2. 7]
2.8 [2.3, 3.3]
2. 8 [2. 3, 3. 3]
3.0 [2.6, 3.4]
3. 0 [2. 6, 3. 4]
3.8 [3.2, 4.4]
3. 8 [3. 2, 4. 4]
3.5 [3.0, 4.0]
3. 5 [3. 0, 4. 0]
4.9 [4.1, 5.7]
4. 9 [4. 1, 5. 7]
Furthermore, Bondenza 3 mg injection every 3 months was proven superior to oral ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p < 0.001, and at two years, p < 0.001.
Barra minn hekk, f’ analiżi prospettiva ippjanata ma ’ l- ewwel sena, p=0. 001, u mas- sentejn, p < 0. 001, ġie ppruvat li injezzjoni ta ’ Bondenza 3 mg darba kull 3 xhur kienet superjuri għal ibandronic acid 2. 5 mg kuljum għal żidiet fil- BMD tas- sinsla lumbari.
For lumbar spine BMD, 92.1% of patients receiving 3 mg injection every 3 months increased or maintained their BMD after 1 year of treatment (i. e. were responders) compared with 84.9% of patients receiving oral 2.5 mg daily (p=0.002).
Għall- BMD tas- sinsla lombari, 92. 1% tal- pazjenti li kienu qed jirċievu injezzjoni ta ’ 3 mg kull 3 xhur żiedu jew żammew il- BMD tagħhom wara sena ta ’ kura (i. e dawk li rrispondew), meta mqabbel ma ’ 84. 9% tal- pazjenti li kienu qed jirċievu Bondenza 2. 5 mg kuljum (p=0. 002).
After 2 years of treatment, 92.8% of patients receiving 3 mg injections and 84.7% of patient receiving 2.5 mg oral therapy had increased or maintained lumbar spine BMD (p=0.001).
Wara sentejn ta ’ kura, 92. 8% tal- pazjenti li kienu qed jirċievu injezzjonijiet ta ’ 3 mg u 84. 7% tal- pazjenti li kienu qed jirċievu 2. 5 mg ta ’ terapija orali kellhom BMD tas- sinsla lumbari miżjud jew miżmum (p=0. 001).
For total hip BMD, 82.3% of patients receiving 3 mg injection every 3 months were responders at one year, compared with 75.1% of patients receiving 2.5 mg daily orally (p=0.02).
Għal BMD totali tal- ġembejn, 82. 3% tal- pazjenti li kienu qed jirċievu injezzjoni ta ’ 3 mg kull 3 xhur kienu dawk li rripsondew wara sena, meta mqabbel ma ’ 75. 1% tal- pazjenti li kienu qed jirċievu 2. 5 mg orali kuljum (p=0. 02).
After 2 years of treatment, 85.6% of patients receiving 3 mg injections and 77.0% of patient receiving 2.5 mg oral therapy had increased or maintained total hip BMD (p=0.004).
Wara sentejn ta ’ kura, 85. 6% tal- pazjenti li kienu qed jirċievu injezzjonijiet ta ’ 3 mg u 77. 0% tal- pazjenti li kienu qed jirċievu 2. 5 mg ta ’ terapija orali kellhom BMD totali tal - ġembejn miżjud jew miżmum (p=0. 004).
The proportion of patients who increased or maintained their BMD at one year at both lumbar spine and total hip was 76.2% in the 3 mg injection every 3 months arm and 67.2% in the 2.5 mg daily orally arm (p=0.007).
Il- proporzjon ta ’ pazjenti li żiedu jew żammew il- BMD tagħhom wara sena kemm fis- sinsla lumbari kif ukoll fil- ġembejn totali kien ta ’ 76. 2% fil- grupp ta ’ injezzjoni ta ’ 3 mg kull 3 xhur u 67. 2% fil - grupp ta ’ 2. 5 mg orali kuljum (p=0. 007).
At two years, 80.1% and 68.8% of patients met this criterion in the 3 mg every 3 months injection arm and the 2.5 mg daily arm (p=0.001).
Mas- sentejn, 80. 1% u 68. 8% tal- pazjenti laħqu dan il - kriterju fil- grupp ta ’ injezzjoni ta ’ 3 mg mg kull 3 xhur u fil- grupp ta ’ 2. 5 mg kuljum (p=0. 001).
Biochemical markers of bone turn-over
Markaturi biokimiċi tat- tibdil ta ’ l- għadam
Clinically meaningful reductions in serum CTX levels were observed at all time points measured.
Tnaqqis ta ’ sinifikat kliniku fil- livelli fis- serum ta ’ CTX kienu osservati fil- punti kollha ta ’ ħin imkejjla.
At 12 months median relative changes from baseline were – 58.6% for the intravenous injection of 3 mg every 3 months regimen and – 62.6% for oral 2.5 mg daily regimen.
Wara 12- il xahar, bidliet medjani relattivi mil- linja bażi kienu ta ’ – 58. 6% għall- injezzjoni ġol- vini ta ’ 3 mg kull 3 xhur u – 62. 6% għall- kors ta ’ 2. 5 mg orali kuljum.
In addition, 64.8% of patients receiving 3 mg every 3 months injection were identified as responders (defined as a decrease ≥ 50% from baseline), compared with 64.9% of patients receiving 2.5 mg daily orally.
Barra minn hekk 64. 8% tal- pazjenti li kienu qed jirċievu injezzjoni ta ’ 3 mg kull 3 xhur kienu identifikati bħala dawk li rrispondew (definiti bħala tnaqqis ta ’ ≥50% mil- linja bażi), meta mqabbel ma ’ 64. 9% tal- pazjenti li kienu qed jirċievu 2. 5 mg orali kuljum.
Serum CTX reduction was maintained over the 2 years, with more than half of the patients identified as responders in both treatment groups.
Tnaqqis tas- CTX fis- serum kien miżmum tul is- sentejn, b’ aktar minn nofs il- pazjenti identifikati bħala dawk li rrispondew fiż- żewġ gruppi ta ’ kura.
Based on the results of study BM 16550, Bondenza 3 mg intravenous injection, administered every 3 months is expected to be at least as effective in preventing fractures as the oral regimen of ibandronic acid 2.5 mg daily.
Ibbażat fuq ir- riżultati ta ’ l- istudju BM 16550, Bondenza 3 mg injezzjoni ġol- vini darba kull 3 xhur huwa mistenni li jkun minn ta ’ l- inqas effettiv daqs ibandronic acid 2. 5 mg kuljum biex jipprevjeni l - ksur.
22 Ibandronic acid 2.5 mg daily tablets
22 Pilloli ibandronic acid 2. 5 mg kuljum
The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at the lumbar spine of -2 to -5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
L- istudju involva nisa b’ età minn 55 sa 80 sena, li kienu mill- inqas 5 snin wara l- menopawża u li kellhom BMD fis- sinsla lumbari ta ’ - 2 sa - 5 SD taħt il- medja ta ’ qabel il- menopawża (punteġġ T) f’ mill- inqas vertebra waħda [L1- L4], u li kellhom minn wieħed sa erba ’ ksur vertebrali prevalenti.
Efficacy was evaluated in 2,928 patients.
L- effikaċja ġiet evalwata f’ 2, 928 pazjent.
Ibandronic acid 2.5 mg administered daily, showed a statistically significant and medically relevant reduction in the incidence of new vertebral fractures.
Ibandronic acid 2. 5 mg mogħti kuljum wera tnaqqis statistikament sinifikanti u ta ’ relevanza medika fl- inċidenza ta ’ ksur vertebrali ġdid.
The incidence of clinical vertebral fractures was also significantly reduced by 49% after 3 years (p=0.011).
L- inċidenza ta ’ ksur vertebrali kliniku kienet ukoll mnaqqsa b’ mod sinifikanti b’ 49% wara 3 snin (p=0. 011).
The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p < 0.0001).
L- effett qawwi fuq il- ksur vertebrali kien rifless ukoll minn tnaqqis statistikament sinifikanti ta ’ telf fit- tul meta mqabbel mal- plaċebo (p < 0. 0001).
Results from 3 years fracture study MF 4411 (%, 95% CI)
Riżultati mill- istudju fuq 3 snin dwar il- ksur, MF 4411 (%, 95% CI)
9.56% (7.5, 11.7)
62% (40. 9, 75. 1)
4.68%
9. 56% (7. 5, 11. 7)
(3.2, 6.2)
4. 68% (3. 2, 6. 2)
Relative risk reduction of clinical
Tnaqqis relattiv tar- riskju ta ’ ksur vertebrali kliniku
49%
49% (14. 03, 69. 49)
Incidence of clinical vertebral fracture
Inċidenza ta ’ ksur vertebrali kliniku
5.33% (3.73, 6.92)
5. 33% (3. 73, 6. 92)
2.75% (1.61, 3.89)
2. 75% (1. 61, 3. 89)
BMD – mean change relative to baseline lumbar spine at year 3
BMD – bidla medja relattiva għas - sinsla lumbari fil- linja bażi fit- tielet sena
1.26% (0.8, 1.7)
1. 26% (0. 8, 1. 7)
6.54% (6.1, 7.0)
6. 54% (6. 1, 7. 0)
BMD – mean change relative to baseline total hip at year 3
BMD – bidla medja relattiva għal - linja bażi tal- ġenbejn totali fit- tielet sena
The treatment effect of ibandronic acid was further assessed in an analysis of the subpopulation of patients who, at baseline, had a lumbar spine BMD T-score below – 2.5 (table 5).
L- effett tal- kura ta ’ ibandronic acid kien evalwat ukoll f’ analiżi tas- sottopopolazzjoni ta ’ pazjenti li fil- linja bażi kellhom il- punteġġ T tal- BMD tas- sinsla lumbari taħt - 2. 5 (tabella 5).
23
23 Tabella 5:
Placebo
Plaċebo (N=587)
ibandronic acid 2.5 mg daily
ibandronic acid 2. 5 mg kuljum (N=575)
(N=587)
Tnaqqis relattiv tar- riskju Ksur vertebrali morfometriku ġdid
(N=575)
59% (34. 5, 74. 3)
Incidence of clinical vertebral fracture
Inċidenza ta ’ ksur vertebrali morfometriku ġdid
6.97% (4.67, 9.27)
5. 36% (3. 31, 7. 41)
Daily oral treatment with ibandronic acid 2.5 mg tablets resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Kura orali kuljum b’ pilloli ibandronic acid 2. 5 mg irriżultat f’ żidiet progressivi fil- BMD f’ postijiet vertebrali u mhux vertebrali ta ’ l- iskeletru.
Biochemical markers of bone turnover (such as urinary CTX and serum Osteocalcin) showed the expected pattern of suppression to premenopausal levels and reached maximum suppression within a period of 3 - 6 months of using 2.5 mg ibandronic acid daily.
Markaturi biokimiċi tal- bidla ta ’ l- għadam (bħal CTX urinarju u Osteocalcin tas- serum) urew id - disinn mistenni tas- soppressjoni għal- livelli ta ’ qabel il- menopawża u laħqu s- soppressjoni massima f’ perijodu ta ’ 3 - 6 xhur ta ’ użu ta ’ ibandronic acid 2. 5 mg kuljum.
A clinically meaningful reduction of 50% of biochemical markers of bone resorption was observed as early as one month after starting treatment with ibandronic acid 2.5 mg.
Tnaqqis ta ’ sinifikanza klinika ta ’ 50% tal- markaturi biokimiċi ta ’ assorbiment mill- ġdid ta ’ l- għadam kien osservat minn xahar wara l- bidu tal- kura b’ ibandronic acid 2. 5 mg.
Plasma concentrations of ibandronic acid increase in a dose-proportional manner after intravenous administration of 0.5 mg to 6 mg.
Konċentrazzjonijiet fil- plażma ta ’ ibandronic acid jiżdiedu b’ mod proporzjonali mad- doża wara għotja ġol- vini ta ’ 0. 5 mg sa 6 mg.
Absorption Not applicable
Assorbiment Ma jgħoddx f’ dan il- każ.
Distribution After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine.
Distribuzzjoni Wara espożizzjoni sistematika inizjali, ibandronic acid jingħaqad malajr mal- għadam jew jitneħħa fl - urina.
In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40 – 50% of the circulating dose.
Fil- bnedmin, il- volum ta ’ distribuzzjoni terminali apparenti huwa mill- inqas 90 1 u l- ammont ta ’ doża li tilħaq l- għadam hija stmata li hija 40 - 50% tad- doża li tkun qed tiċċirkola.
Protein binding in human plasma 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.
It- twaħħil mal - proteini fil- plażma umana hija madwar 85% - 87% (determinata in vitro f’ konċentrazzjonijiet terapewtiċi ta ’ ibandronic acid), u għalhekk hemm potenzjal żgħir għall- interazzjoni ma ’ prodotti mediċinali minħabba spostament.
Metabolism There is no evidence that ibandronic acid is metabolised in animals or humans.
24 Metaboliżmu M’ hemm l- ebda evidenza li ibandronic acid huwa metabolizzat fl- annimali jew fil- bnedmin.
Elimination Ibandronic acid is removed from the circulation via bone absorption (estimated to be 40 – 50% in postmenopausal women) and the remainder is eliminated unchanged by the kidney.
Eliminazzjoni Ibandronic acid jitneħħa miċ- ċirkolazzjoni permezz ta ’ assorbiment fl- għadam (stmat li huwa 40 - 50% f’ nisa wara l- menopawża) u l- bqija jiġi eliminat mingħajr ma jinbidel mill- kliewi.
The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10 - 72 hours.
L- skala tal- half- lifes apparenti osservati hija wiesgħa, l- half- life terminali apparenti ġeneralment hija fl- iskala ta ’ 10 - 72 siegħa.
Early plasma levels fall quickly, reaching 10% of the peak values within 3 and 8 hours after intravenous or oral administration, respectively.
Livelli bikrija fil- plażma jinżlu malajr u jilħqu 10% tal- valuri massimi fi 3 u 8 sigħat wara għoti minn ġol- vini jew mill- ħalq rispettivament.
24 Total clearance of ibandronic acid is low with average values in the range 84 - 160 ml/ min.
It- tneħħija totali ta ’ ibandronic acid hija baxxa b’ valuri medji fl- iskla ta ’ 84 - 160 ml/ min.
Renal clearance (about 60 ml/ min in healthy postmenopausal females) accounts for 50 – 60% of total clearance, and is related to creatinine clearance.
It- tneħħija mill- kliewi (madwar 60 ml/ min f’ nisa b’ saħħithom wara l- menopawża) tkopri 50 - 60% tat- tneħħija totali u hija relatata mat- tneħħija tal- krejatinina.
Gender Pharmacokinetics of ibandronic acid are similar in men and women.
Sess L- farmakokinetika ta ’ ibandronic acid huma simili fl- irġiel u fin- nisa.
There is limited data available on patients of African origin.
Hemm tagħrif limitat disponibbli dwar pazjenti ta ’ oriġini Afrikana.
Patients with renal impairment Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance (CLcr).
Pazjenti b’ indeboliment tal- kliewi It- tneħħija ta ’ ibandronic acid mill- kliewi f’ pazjenti bi gradi diversi ta ’ indeboliment tal- kliewi hija relatata b’ mod lineari mat- tneħħija tal- krejatinina (CLcr).
No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or above 30 ml/ min).
L- ebda tibdil tad- doża ma hu meħtieġ għall- pazjenti b’ indeboliment ħafif jew moderat tal- kliewi (CLcr ugwali jew aktar minn 30 ml/ min).
Subjects with severe renal impairment (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.
Individwi b’ indeboliment sever tal- kliewi (CLcr inqas minn 30 ml/ min) li rċevew għoti orali kuljum ta ’ 10 mg ibandronic acid għal 21 ġurnata, kellhom konċentrazzjonijiet fil- plażma 2 - 3 darbiet għola minn individwi b’ funzjoni tal- kliewi normali u t- tneħħija totali ta ’ ibandronic acid kienet ta ’ 44 ml/ min.
After intravenous administration of 0.5 mg of ibandronic acid, 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.
Wara għoti minn ġol- vini ta ’ 0. 5 mg ta ’ ibandronic acid, it- tneħħija totali, renali u mhux renali naqsu b’ 67%, 77% u 50% rispettivament, f’ individwi b’ insuffiċjenza severa tal- kliewi iżda ma kien hemm l- ebda tnaqqis fit- tollerabilità assoċjata maż- żjieda fl- espożizzjoni.
Due to the limited clinical experience, Bondenza is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Minħabba li l - esperjenza klinika hija limitata, Bondenza mhux rakkomandat f’ pazjenti b’ indeboliment sever tal - kliewi (ara sezzjoni 4. 2 u sezzjoni 4. 4).
The pharmacokinetics of ibandronic acid in patients with end-stage renal disease was only assessed in a small number of patients managed by haemodialysis, therefore, the pharmacokinetics of ibandronic acid in the patients not undergoing haemodialysis is unknown.
Il- farmakokinetika ta ’ ibandronic acid f’ pazjenti b’ marda tal - kliewi ta ’ l- aħħar stadju kienet stmata biss f’ numru żgħir ta ’ pazjenti immaniġġjati b’ emodijalisi, għalhekk il- farmakokinetika ta ’ ibandronic acid f’ pazjenti mhux fuq emodijalisi mhux magħrufa.
Due to the limited data available, ibandronic acid should not be used in all patients with end-stage renal disease.
Minħabba tagħrif limitat, ibandronic acid m’ għandux jintuża fil- pazjenti kollha b’ marda tal- kliewi ta ’ l- aħhar stadju.
The liver has no significant role in the clearance of ibandronic acid, which is not metabolised but is cleared by renal excretion and by uptake into bone.
Il- fwied m’ għandux rwol sinifikanti fit- tneħħija ta ’ ibandronic acid li m’ huwiex metabolizzat iżda jitneħħa permezz ta ’ eskrezzjoni mill- kliewi u minn teħid fl- għadam.
Elderly Population In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Popolazzjoni Anzjana F’ analiżi multivarjata, l- età ma nstabitx li hija fattur indipendenti fl- ebda wieħed mill- parametri farmakokinetiċi studjati.
As renal function decreases with age, renal function is the only factor to take into consideration (see renal impairment section).
Billi l- funzjoni tal- kliewi tonqos bl- età, l- funzjoni tal- kliewi hija l- uniku fattur li għandu jittieħed f’ konsiderazzjoni (ara s- sezzjoni dwar l- indeboliment tal- kliewi).
Paediatric Population There are no data on the use of Bondenza in these age groups.
25 Popolazzjoni Pedjatrika M’ hemm l- ebda tagħrif dwar l- użu ta ’ Bondenza f’ dawn il- gruppi ta ’ etajiet.
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.
Effetti tossiċi, e. ż. sinjali ta ’ ħsara fil- kliewi, ġew osservati fil- klieb biss f’ espożizzjonijiet ikkunsidrati suffiċjentement akbar mill- espożizzjoni massima fil- bniedem u jindikaw relevanza żgħira għall- użu kliniku.
Specific studies for the 3-monthly dosing regimen have not been performed.
Tossiċità riproduttiva Ma sarux studji speċifiċi għall- kors ta ’ dożaġġ ta ’ kull 3 xhur.
In studies with daily i. v. dosing regimen, there was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in rats and rabbits.
Fi studji b’ kors ta ’ dożaġġ i. v. kuljum ma kien hemm l- ebda evidenza ta ’ effett tossiku dirett fuq il- fetu jew effett teratoġeniku ta ’ ibandronic acid f’ firien u fniek.
Body weight gain was decreased in F1 offspring in rats.
Żieda fil- piż tal- ġisem naqset fl- ulied F1 fil- firien.
Other adverse reactions to ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Reazzjonijiet avversi oħra għal ibandronic acid fi studji tat- tossiċità riproduttiva fil- far kienu dawk osservati bil- bisphosphonates bħala klassi.
Sodium chloride Glacial acetic acid Sodium acetate trihydrate Water for injections
Sodium chloride Glacial acetic acid Sodium acetate trihydrate Ilma għall- injezzjonijiet
Bondenza solution for injection must not be mixed with calcium-containing solutions or other intravenously administered medicinal products.
Soluzzjoni għall- injezzjoni Bondenza m’ għandiex titħallat ma ’ soluzzjonijiet li fihom il- kalċju jew ma ’ prodotti mediċinali oħra li jingħataw ġol- vini.
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fiħ
Pre-filled syringes (5 ml) made of colourless type I glass, the grey rubber plunger stopper and tip cap are made of fluororesin-laminated butyl rubber, containing 3 ml of solution for injection.
Siringi mimlija għal- lest (5 ml) li fihom 3 ml ta ’ soluzzjoni għall- injezzjoni, magħmula minn ħġieġ bla kulur tat- Tip I, it- tapp tal- planġer griż tal- lasktu u l- għatu tat- tarf huma magħmula minn lastku llaminat b’ fluororesin.
Packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
Pakketti ta ’ siringa mimlija għal- lest waħda u labra għall- injezzjoni waħda jew 4 siringi mimlija għal - lest u 4 labar għall- injezzjoni.
6.6 Special precautions for disposal
26 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Where the product is administered into an existing intravenous infusion line, the infusate should be restricted to either isotonic saline or 50 mg/ ml (5%) glucose solution.
Fejn il- prodott jingħata ġo linja ta ’ l- infużjoni ġol- vini eżistenti, is- soluzzjoni għall- infużjoni għandha tiġi limitata għal isotonic saline jew soluzzjoni tal- glukosju ta ’ 50 mg/ ml (5%).
This also applies to solutions used to flush butterfly and other devices.
Dan jgħodd ukoll għal soluzzjonijiet użati biex ilaħalħu l- farfett u apparat ieħor.
Any unused solution for injection, syringe and injection needle should be disposed of in accordance with local requirements.
Kull soluzzjoni għall- injezzjoni, siringa jew labra għall- injezzjoni mhux użati għandhom jintremew skond il- liġijiet lokali.
27 ANNEX II
27 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
28 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
28 A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Film-coated tablet:
Pillola miksija b’ rita:
Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Roche Pharma AG Emil- Barell- Strasse 1 D- 79639 Grenzach- Wyhlen Il- Ġermanja
Solution for injection in pre-filled syringe:
Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest:
Roche Diagnostics GmbH Sandhoferstrasse 116 D-68305 Mannheim Germany
Roche Diagnostics GmbH Sandhoferstrasse 116 D- 68305 Mannheim Il- Ġermanja
B CONDITIONS OF THE MARKETING AUTHORISATION
B KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq se jkompli jissottometti PSURs kull sena, sakemm ma jkunx speċifikat mod ieħor mis- CHMP.
The MAH must ensure that the system of pharmacovigilance, as described in the document “ Description of the PharmacoVigilance system” submitted on 16 November 2005, and any subsequent updates, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt fid- dokument “ Deskrizzjoni tas- Sistema ta ’ Farmakoviġilanza ” ippreżentat fis- 16 ta ’ Novembru 2005, u kull aġġornament sussegwenti, hija f’ postha u qed tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan
Pjan għall- Immanniġġjar ta ’ Riskji
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan (RMP) report No.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq iwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fir- rapport tal- Pjan għall- Immaniġġjar ta ’ Riskji (RMP) No.
1021880 submitted on 23 May 2006, and any subsequent updates of the RMP agreed by the CHMP.
1021880 ippreżentat fit- 23 ta ’ Mejju 2006, u kull aġġornament sussegwenti tal- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida tas- CHMP dwar is- Sistemi għall- Immaniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem, l- RMP imġedded għandu jiġi pprovdut fl- istess żmien mar- Rapport Perjodiku Aġġornat dwar is- Sigurtà (PSUR) li jmiss.
In addition, an updated RMP should be submitted:
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
29 • Meta tinkiseb informazzjoni ġdida li jista ’ jkollha effett fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskju
29 • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
• Fi żmien 60 ġurnata wara li jintlaħaq għan ewlieni (farmakoviġilanza jew tnaqqis ta ’ riskju)
• At the request of the EMEA
• Fuq talba ta ’ l- EMEA
30 ANNEX III
30 ANNESS III
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bondenza 150 mg film-coated tablets Ibandronic acid
Bondenza 150 mg pilloli miksija b’ rita Ibandronic acid
Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic sodium monohydrate).
Kull pillola miksija b’ rita fiha 150 mg ta ’ ibandronic acid (bħala ibandronic sodium monohydrate).
Also contains lactose.
Fih ukoll lactose.
See the package leaflet for further information
Għall- aktar informazzjoni ara l- fuljett ta ’ tagħrif
1 film-coated tablet 3 film-coated tablets
Pillola miksija b’ rita 3 pilloli miksija b’ rita
Once monthly tablet Oral use Read the package leaflet before use
MOD TA ’ KIF U MNEJN JINGĦATA
Month 1 __/__/__ 3 film-coated tablets Month 2 __/__/__ 3 film-coated tablets Month 3 __/__/__ 3 film-coated tablets Note down the date you take your tablet Open
3 __ / __ / __ 3 pilloli miksija b’ rita Niżżel id- data ta ’ meta tieħu l- pillola tiegħek Iftaħ
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA ’ JINTLAĦAQX U MA ’ JIDHIRX MIT- TFAL
Keep out of the reach and sight of children
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
EU/1/03/266/003 1 film-coated tablet EU/1/03/266/004 3 film-coated tablets
EU/ 1/ 03/ 266/ 003 pillola miksija b’ rita EU/ 1/ 03/ 266/ 004 3 pilloli miksija b’ rita
Medicinal product subject to medical prescription
Prodott mediċinali jingħata bir- riċetta tat- tabib
34 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister foil
Folja
NAME OF THE MEDICINAL PRODUCT
ISEM TAL - PRODOTT MEDIĊINALI
Bondenza 150 mg film-coated tablets Ibandronic acid
Bondenza 150 mg pilloli miksija b’ rita ibandronic acid
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bondenza 3 mg solution for injection Ibandronic acid
Bondenza 3 mg soluzzjoni għall- injezzjoni Ibandronic acid
One pre-filled syringe of 3 ml solution contains 3 mg of ibandronic acid (as 3.375 mg of ibandronic acid, monosodium salt, monohydrate).
Siringa mimlija għal lest b’ 3 ml ta ’ soluzzjoni fiha 3 mg ibandronic acid (bħala 3. 375 mg ibandronic acid, monosodium salt, monohydrate).
Also contains sodium chloride, glacial acetic acid, sodium acetate trihydrate, water for injections.
Fih ukoll sodium chloride, glacial acetic acid, sodium acetate trihydrate, ilma għall- injezzjonijiet.
solution for injection 1 pre-filled syringe + 1 injection needle 4 pre-filled syringes + 4 injection needles
soluzzjoni għall- injezzjoni Siringa mimlija għal- lest waħda + labra għall- injezzjoni waħda 4 siringi mimlija għal- lest + 4 labar għall- injezzjoni.
For intravenous use only Read the package leaflet before use
Użu għal ġol- vini biss Aqra l- fuljett ta ’ tagħrif qabel l- użu
EU/1/03/266/005 1 pre-filled syringe EU/1/03/266/006 4 pre-filled syringes
EU/ 1/ 03/ 266/ 005 siringa mimlija għal- lest EU/ 1/ 03/ 266/ 006 4 siringi mimlija għal- lest
[Justification for not including Braille accepted]
[Il- ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettataMa jgħoddx f’ dan il- każ]
37 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PRE-FILLED SYRINGE
SIRINGA MIMLIJA GĦAL- LEST
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI
Bondenza 3 mg solution for injection Ibandronic acid For IV use only
Bondenza 3 mg soluzzjoni għall- injezzjoni Ibandronic acid Użu għal ġol- vini biss
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu
39 PACKAGE LEAFLET:
39 FULJETT TA ’ TAGĦRIF:
Bondenza 150 mg film-coated tablets Ibandronic acid
BONDENZA 150 mg pilloli miksija b’ rita Ibandronic acid
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
Do not pass it on to others.
M’ għandekx tgħaddiha lill- persuni oħra.
please tell your doctor.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
Planning when to take Bondenza with peel-off stickers for your personal calendar 1.
Tippjana meta tieħu Bondenza b’ tikketti li jitqaxxru għall- kalendarju personali tiegħek 1.
What Bondenza is and what it is used for 2.
X’ inhu Bondenza u għalxiex jintuża 2.
Before you take Bondenza 3.
Qabel ma ’ tieħu Bondenza 3.
How to take Bondenza 4.
Kif għandek tieħu Bondenza 4.
How to store Bondenza 6.
Kif taħżen Bondenza 6.
WHAT BONDENZA IS AND WHAT IT IS USED FOR
X’ INHU BONDENZA U GĦALXIEX JINTUŻA
Bondenza belongs to a group of medicines called bisphosphonates.
Bondenza jagħmel parti minn grupp ta ’ mediċini msejħa bisphosphonates.
It contains ibandronic acid.
Fih ibandronic acid.
It does not contain hormones.
Ma fihx ormoni.
Bondenza may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won’t be able to see or feel a difference.
Bondenza jista ’ jreġġa lura it- telf ta ’ l- għadam billi jwaqqaf aktar telf ta ’ għadam u jżid il- massa ta ’ l - għadam fil- biċċa l- kbira tan- nisa, anki jekk ma jkunux jistgħu jaraw jew iħossu differenza.
Bondenza may help lower the chances of breaking bones (fractures).
Bonviva jista ’ jgħin inaqqas ir- riskju ta ’ ksur ta ’ għadam (fratturi).
This reduction in fractures was shown for the spine but not for the hip.
Dan it- tnaqqis fil- fratturi kien osservat għas - sinsla tad- dahar iżda mhux għall- ġenbejn.
Bondenza is prescribed to you to treat osteoporosis because you have an increased risk of fractures.
Bondenza huwa preskritt lilek biex jikkura l- osteoporożi għax għandek riskju ogħla ta ’ ksur.
Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause.
L - osteoporożi hija traqqiq u tidjgħif ta ’ l- għadam, li hija komuni f’ nisa wara l- menopawża.
At the menopause, a woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.
Fil - menopawża, l- ovarji tal- mara jieqfu jipproduċu l- ormon femminili, l- estroġenu, li jgħin biex iżomm l - iskeletru tagħha b’ saħħtu.
The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis.
Iżjed ma l- mara tilħaq il- menopawża kmieni, iktar ikun kbir r- riskju tagħha ta ’ ksur fl- osteoporożi.
Other things that can increase the risk of fractures include:
Affarijiet oħra li jistgħu jżidu r- riskju ta ’ ksur jinkludu:
- not enough calcium and vitamin D in the diet
- insuffiċjenza ta ’ kalċju u vitamina D fid- dieta
- smoking, or drinking too much alcohol
- tipjip, jew xorb ta ’ alkoħol żejjed
- not enough w alking or other weight-bearing exercise
- mhux biżżejjed mixi jew eżerċizzju ieħor ta ’ rfigħ ta ’ piżijiet
- a family history of osteoporosis
- passat mediku ta ’ osteoporożi fil- familja
Many people with osteoporosis have no symptoms.
Ħafna persuni bl- osteoporożi ma jkollhom l- ebda sintomi.
If you have no symptoms you may not know if you have the condition.
Jekk ma jkollokx sintomi tista ’ ma tkunx taf li għandek il- kondizzjoni.
However, osteoporosis makes you more likely to break bones if you fall or hurt yourself.
Madankollu, l- osteoporożi tagħmlek iżjed suxxettibbli li tikser l- għadam jekk taqa ’ jew tweġġa ’.
A broken bone after the age of 50 may be a sign of osteoporosis.
Għadma miksura wara l- età ta ’ 50 sena tista ’ tkun sinjal ta ’ osteoporożi.
Osteoporosis can also cause back pain, height loss and a curved back.
L - osteoporożi tista ’ tikkawża wkoll uġigħ fid- dahar, tnaqqis fit- tul u dahar mgħawweġ.
Bondenza prevents loss of bone from osteoporosis, and helps to rebuild bone.
Bondenza jipprevjeni telf ta ’ l- għadam mill- osteoporożi, u jgħin sabiex l- għadam jinbena mill- ġdid.
Therefore Bondenza makes bone less likely to break.
Għalhekk Bondenza jagħmel l- għadam inqas suxxettibbli għal ksur.
40 A healthy lifestyle will also help you to get the most benefit from your treatment.
40 Stil ta ’ ħajja b’ saħħitha ukoll jgħinek biex tieħu l- benefiċċju massimu mill- kura tiegħek.
This includes eating a balanced diet rich in calcium and vitamin D; walking or any other weight-bearing exercise; not smoking; and not drinking too much alcohol.
Dan jinkludi li tiekol dieta bilanċjata b’ ħafna kalċju u vitamina D, li timxi jew tagħmel eżerċizzju ieħor ta ’ rfigħ ta ’ piżijiet; li ma tpejjipx u li ma tixrobx wisq alkoħol.
BEFORE YOU TAKE BONDENZA
QABEL MA ’ TIEĦU BONDENZA
Do not take Bondenza
Tieħux Bondenza
- If you are allergic (hypersensitive) to ibandronic acid, or to any of the other ingredients of
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal ibandronic acid, jew għal xi wieħed
Bondenza.
mis- sustanzi l- oħra ta ’ Bondenza.
- If you have, or had in the past low blood calcium.
- Jekk għandek, jew kellek fil- passat, kalċju baxx fid- demm.
Please consult your doctor.
Jekk jogħġbok kellem lit- tabib
Do not give Bondenza to children or adolescents.
Tagħtix Bondenza lit- tfal jew lill- adoloxxenti.
Take special care with Bondenza Some people need to be especially careful while they’re taking Bondenza.
Oqgħod attent ħafna b’ Bondenza Xi persuni għandhom joqgħodu attenti ħafna meta qed jieħdu Bondenza.
Check with your doctor:
Ikkonsulta mat- tabib tiegħek:
- If you have any disturbances of mineral metabolism (such as vitamin D deficiency).
- Jekk għandek xi disturbi fil- metaboliżmu tal- minerali (bħal defiċjenza ta ’ vitamina D).
- If you can’t stand or sit upright for up to an hour at a time.
- Jekk ma tistax toqgħod bilwieqfa jew bilqegħda dritt għal siegħa sħiħa.
- If your kidneys are not functioning normally.
- Jekk il- kliewi tiegħek mhux qed jaħdmu b’ mod normali.
- If you have ever had problems with your oesophagus (the tube connecting your mouth to your
Jekk qatt kellek xi problemi bl- esofagu (it- tubu li jgħaqqad il- ħalq tiegħek mal- istonku).
Problems in your oesophagus might give you symptoms including: severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting.
Problemi fl- esofagu tiegħek jistgħu jikkawżawlek sintomi li jinkludu: uġigħ qawwi fis- sider, uġigħ qawwi wara li tibla ’ l- ikel u/ jew xorb, tqalligħ sever, jew rimettar.
If you develop these symptoms, speak to your doctor straight away.
Jekk tħoss dawn is- sintomi, kellem lit- tabib tiegħek minnufih.
- If you are under dental treatment or will undergo dental surgery, tell your dentist that you are
Jekk qiegħed taħt kura dentali jew ser tagħmel kirurġija dentali, għarraf lid- dentist tiegħek li qed tiġi kkurat b’ Bondenza.
Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra anki dawk mingħajr riċetta.
Especially:
Speċjalment:
- Supplements containing calcium, magnesium, iron or aluminium, as they could possibly
- Supplimenti li fihom calcium, magnesium, iron jew aluminium, għax dawn jistgħu
influence the effects of Bondenza.
jinfluwenzaw l- effetti ta ’ Bonviva.
- Aspirin and other non-steroidal anti-inflammatory medicines (NSAIDs) (including
- Aspirin u mediċini oħra anti- infjammatorji mhux sterojdi (NSAIDs) (inkluż ibuprofen,
ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine.
diclofenac sodium u naproxen) jistgħu jirritaw l- istonku u l- imsaren.
Bisphosphonates (like Bondenza) may also do so.
Bisphosphonates (bħal Bonviva) jistġħu jagħmlu dan ukoll.
So be especially careful if you take painkillers or anti-inflammatories while you’re taking Bondenza.
Għalhekk oqgħod attent ħafna jekk tieħu xi mediċini għall- uġigħ jew kontra l- infjammazzjoni waqt li qed tieħu Bonviva.
After swallowing your monthly Bondenza tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.
Wara li tibla l- pillola tiegħek ta ’ kull xahar ta ’ Bondenza, stenna għal siegħa qabel tieħu xi mediċina oħra, inkluż pilloli għall- indiġestjoni, supplimenti ta ’ kalċju, jew vitamini.
Taking Bondenza with food and drink:
Meta tieħu Bonviva ma ’ l- ikel u max- xorb:
Do not take Bondenza with food.
Tieħux Bonviva ma ’ l- ikel.
Bondenza is less effective if it’s taken with food.
Bonviva huwa inqas effettiv jekk jittieħed ma ’ l- ikel.
You can drink plain water but no other drinks (see 3.
Tista ’ tixrob ilma waħda iżda ma tistax tieħu xorb ieħor (ara 3.
HOW TO TAKE BONDENZA).
KIF GĦANDEK TIEĦU BONVIVA).
Pregnancy and breast feeding Do not take Bondenza if you’re pregnant or breast feeding.
Tqala u Treddigħ Tieħux Bondenza jekk inti tqila jew qed tredda ’.
If you’re breast feeding, you may need to stop in order to take Bondenza.
Jekk qed tredda ’, jista ’ jkun li jkollok tieqaf sabiex tieħu Bondenza.
Driving and using machines You can drive and use machines as it’s very unlikely that Bondenza will affect your ability to drive and use machines.
Sewqan u tħaddim ta ’ magni Tista ’ issuq u tħaddem magni għax huwa improbabbli ħafna li Bondenza jaffettwa l- abbilità tiegħek li issuq u tħaddemmagni.
41 Important information about some of the ingredients of Bondenza Bondenza contains an ingredient called lactose.
41 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Bondenza Bonviva fih ingredjent imsejjaħ lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi zokkrijiet, kellem lit- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali.
HOW TO TAKE BONDENZA
KIF GĦANDEK TIEĦU BONDENZA
Always take Bondenza exactly as your doctor has told you.
Dejjem għandek tieħu Bondenza skond il- parir tat- tabib.
If you’re not sure about anything, ask your doctor or pharmacist.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
The usual dose of Bondenza is one tablet once a month.
Id- doża tas- soltu ta ’ Bondenza hija pillola waħda kull xahar.
Taking your monthly tablet It’s important to follow these instructions carefully.
Kif tieħu l- pillola ta ’ kull xahar Huwa mportanti li ssegwi dawn l- istruzzjonijiet b’ attenzjoni.
They are designed to help your Bondenza tablet reach your stomach quickly, so it’s less likely to cause irritation.
Huma maħsuba biex jgħinu l- pillola ta ’ Bondenza tasal sa l- istonku tiegħek malajr, u b’ hekk tkun inqas probabbli li tikkawża rritazzjoni.
- Take one Bondenza 150 mg tablet once a month.
- Ħu pillola waħda ta ’ Bondenza 150 mg darba fix- xahar.
- Choose one day of the month that will be easy to remember.
- Għażel ġurnata fix- xahar li tkun faċli biex tiftakar.
You can choose either the same
Tista ’ tagħżel jew l- istess data (bħal l -
date (such as the 1st of each month) or the same day (such as the first Sunday of each month) to take your Bondenza tablet.
ewwel ġurnata ta ’ kull xahar) jew l- istess ġurnata (bħal l- ewwel Ħadd ta ’ kull xhar) biex tieħu l - pillola tiegħek ta ’ Bondenza.
Choose the date that best fits your routine.
Għażel id- data li taqbel l- aħjar mar- rutina tiegħek.
- Take your Bondenza tablet at least 6 hours after you last had anything to eat or drink except
- Ħu l- pillola tiegħek ta ’ Bondenza mill- inqas 6 sigħat minn meta tkun kilt xi ħaġa jew xrobt
plain water.
għajr ilma waħdu.
- Take your Bondenza tablet
- Ħu l- pillola tiegħek ta ’ Bondenza
- -
- wara li tqum l- ewwel darba matul il- ġurnata, u
after you first get up for the day, and before you have anything to eat or drink (on an empty stomach)
- qabel ma tiekol jew tixrob (fuq stonku vojt)
- Swallow your tablet with a full glass of plain water (at least 180 ml).
- Ibla ’ l- pillola tiegħek ma ’ tazza mimlija bl- ilma waħdu (mill- inqas 180 ml)
Do not take your tablet with mineral water, fruit juice or any other drinks.
Tieħux il- pillola tiegħek ma ’ ilma minerali, meraq tal- frott, jew xi xorb ieħor.
- Swallow your tablet whole — do not chew it, crush it or let it dissolve in your mouth.
- Ibla ’ l- pillola tiegħek sħiħa – M’ għandekx tomgħodha, tisħaqha jew tħalliha tinħall f’ ħalqek.
- For the next hour (60 minutes) after you’ve taken your tablet
- Għas- siegħa sussegwenti (60 minuta) wara li tkun ħadt il- pillola tiegħek:
do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus
- timteddx; jekk ma toqgħodx dritt (bilwieqfa jew bilqegħda), xi ftit mill- mediċina tista ’ terġa ’
do not eat anything
tiekol xejn
do not drink anything (except plain water if you need it) do not take any other medicines
tixrob xejn (għajr ilma waħdu jekk għandek bżonnu) tieħux mediċini oħra
- After you’ve waited for an hour, you can have your first food and drink of the day.
- Wara li tkun stennejt għal siegħa, tista ’ tieħu l- ewwel ikel u xorb tal- ġurnata.
Once you’ve
Ġaladarba tkun
eaten, it’s OK to lie down if you wish, and to take any other medication you need.
kilt, jekk trid tista ’ timtedd, u tista ’ tieħu kwalunkwe mediċina oħra li teħtieġ.
Do not take your tablet at bedtime or before you get up for the day.
Tieħux il- pillola tiegħek fil- ħin ta ’ l- irqad jew qabel ma tqum għall- ġurnata.
42 Continuing to take Bondenza It’s important to keep taking Bondenza every month, as long as your doctor prescribes it for you.
42 Kompli ħu Bondenza Huwa importanti li tkompli tieħu Bondenza kull xahar, sakemm jippreskrivulek it- tabib tiegħek.
Bondenza can treat osteoporosis only as long as you keep taking it.
Bondenza jista ’ jikkura l- osteoporożi sakemm tibqa ’ tieħdu biss.
If you take too much Bondenza If you’ve taken more than one tablet by mistake, drink a full glass of milk and talk to your doctor straight away.
Jekk ħadt aktar minn pillola waħda bi żball, ixrob tazza sħiħa ħalib u kellem lit- tabib tiegħek immedjatament.
Do not make yourself vomit, and do not lie down — this could cause Bondenza to irritate your oesophagus.
Iġġiegħelx lilek innifsek tirremetti, u timteddx – dan jista ’ jikkawża li Bondenza jirrita l- esofagu.
If you forget a dose If you forget to take your tablet on the morning of your chosen day, do not take a tablet later in the day.
Jekk tinsa tieħu doża Jekk tinsa tieħu l- pillola tiegħek filgħodu tal- ġurnata magħżula tiegħek, tieħux pillola aktar tard matul il- ġurnata.
Instead, consult your calendar and find out when your next scheduled dose is:
Minflok ikkonsulta mal- kalendarju tiegħek u ara meta jmiss id- doża pprogrammata tiegħek:
If your next scheduled dose is only 1 to 7 days away… You should wait until the next scheduled dose is due and take it as normal; then, continue taking one tablet once a month on the scheduled days you’ve marked on your calendar.
Jekk id- doża pprogrammata li jmiss tiegħek hija biss ġurnata sa 7 ijiem ’ l bogħod...
If your next scheduled dose is more than 7 days away… You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you’ve marked on your calendar.
kalendarju tiegħek Jekk id- doża pprogrammata li jmiss tiegħek baqalha aktar minn 7 ijiem … Għandek tieħu pillola waħda l- għada filgħodu tal- ġurnata li tiftakar; - wara, kompli ħu pillola waħda darba fix- xahar fil- ġranet ipprogrammati li mmarkajt fuq il- kalendarju tiegħek
Never take two Bondenza tablets within the same week.
Tieħu qatt żewġ pilloli Bondenza fl- istess ġimgħa
Like all medicines, Bondenza can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Bondenza jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These side effects may occur with certain frequencies, which are defined as follows:
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċertu frekwenzi li huma definiti kif ġej:
- very common: affects more than 1 user in 10
- komuni ħafna: jaffettwaw aktar minn persuna waħda minn kull 10 li qed jużawh
- common: affects 1 to 10 users in 100
- komuni: jaffettwaw minn persuna waħda sa 10 minn kull 100 li qed jużawh
- uncommon: affects 1 to 10 users in 1,000
- mhux komuni: jaffettwaw minn persuna waħda sa 10 minn kull 1, 000 li qed jużawh
- rare: affects 1 to 10 users in 10,000
- rari: jaffettwaw minn persuna waħda sa 10 minn kull 10, 000 li qed jużawh
- very rare: affects less than 1 user in 10,000
- rari ħafna: jaffettwaw inqas minn persuna waħda minn kull 100, 000 li qed jużawh
- not known: frequency cannot be estimated from the available data.
- mhux magħruf: il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli.
Common side effects are heartburn, indigestion, diarrhoea, stomach ache, nausea and flatulence.
Effetti sekondarji komuni huma ħruq ta ’ stonku, indiġestjoni, dijarea, uġigħ ta ’ żaqq, dardir u gass fl- istonku..