qanastek/EMEA-V3 huggingface dataset:
Other information about Bondenza:
Informazzjoni oħra dwar Bondenza:
The European Commission granted a marketing authorisation valid throughout the European Union for Ibandronic Acid Roche to Roche Registration Limited on 23 February 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Ibandronic Acid Roche lil Roche Registration Limited fit- 23 ta ’ Frar 2004.
The name of the medicine was changed to Bondenza on 18 August 2004.
L- isem tal- mediċina nbidel f’ Bondenza fit- 18 ta ’ Awwissu 2004.
The marketing authorisation was renewed on 23 February 2009.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit - 23 ta ’ Frar 2009.
The full EPAR for Bondenza can be found here.
L- EPAR sħiħ għal Bondenza jista ’ jiġi kkonsultat hawn.
This summary was last updated in 02-2009.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Invented name
Isem
Film-coated tablet Film-coated tablet
Pilloli Miksija B’ rita Pilloli Miksija B’ rita
Oral use Oral use
Użu Orali Użu Orali
Blister (PVC/ PVDC) Blister (PVC/ PVDC)
Folja (PVC/ PVDC) Folja (PVC/ PVDC)
1 tablet 3 tablets
1 pillola 3 pilloli
Solution for injection
Soluzzjoni Għall - Injezzjoni
Intravenous
F’ siringa Mimlija Għal Lest
Pre-filled syringe (glass)
Siringa Mimlija Għal - 3mg (1mg/ ml) Lest (Ħġieġ)
1 pre-filled syringe
1 siringa mimlija għal- lest waħda
4 pre-filled syringes
4 siringi mimlija għal- lest
ANNEX I
ANNESS 1
Bondenza 150 mg film-coated tablets
Bondenza 150 mg pilloli miksija b’ rita.
Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic sodium monohydrate).
Kull pillola miksija b’ rita fiha 150 mg ibandronic acid (bħala ibandronic sodium monohydrate).
Each film-coated tablet contains 162.75 mg lactose monohydrate.
Kull pillola miksija b’ rita fiha 162. 75 mg lactose monohydrate.
Film-coated tablet White to off white film-coated tablets, of oblong shape marked “ BNVA” on one side, and “ 150” on the other side.
Pillola miksija b’ rita Pilloli bojod sa fl- offwajt miksija b’ rita, b’ forma oblung immarkati “ BNVA ” fuq naħa u “ 150 ” fuq in - naħa l- oħra.
Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).
Kura ta ’ l- osteoporożi fin- nisa f’ riskju akbar ta ’ ksur wara l- menopawża (ara sezzjoni 5. 1).
A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Intwera tnaqqis fir- riskju ta ’ ksur vertebrali, l- effikaċja fuq il- ksur ta ’ l- għonq femorali għadha ma ġietx stabbilita.
Posology:
Pożoloġija:
The recommended dose is one 150 mg film-coated tablet once a month.
Id- doża rakkomandata hija ta ’ pillola waħda miksija b’ rita ta ’ 150 mg darba kull xahar.
The tablet should preferably be taken on the same date each month.
Preferibilment, il- pillola għandha tittieħed fl- istess data kull xahar.
Bondenza 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).
Bondenza għandu jittieħed wara lejl ta ’ sawm (mill- inqas 6 sigħat) u siegħa qabel l- ewwel ikel jew xorb (għajr ilma) tal- ġurnata (ara sezzjoni 4. 5) jew kwalunkwe prodott mediċinali jew supplimentazzjoni (inkluż kalċju) oħra li jittieħdu mill- ħalq:
In case a dose is missed, patients should be instructed to take one Bondenza 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days.
F’ każ li tinqabeż doża, il- pazjenti għandhom jiġu informati biex jieħdu pillola waħda ta ’ Bondenza 150 mg filgħodu wara li l- pillola tiġi mfakkra, sakemm il- ħin sad- doża pprogrammata li jmiss huwa fi żmien sebat ijiem.
Patients should then return to taking their dose once a month on their originally scheduled date.
Wara, l- pazjenti għandhom ikomplu jieħdu d- doża tagħhom darba fix- xahar fid - data pprogrammata oriġinali tagħhom.
If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled.
Jekk id- doża pprogrammata li jmiss hija fi żmien sebat ijiem, il- pazjenti għandhom jistennew sad - doża li jmiss u wara jkomplu jieħdu pillola waħda darba fix- xahar kif ipprogrammat oriġinarjament.
Patients should not take two tablets within the same week.
Il- pazjenti m’ għandhomx jieħdu żewġ pilloli fl- istess ġimgħa.
Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate (see section 4.4 and section 4.5).
Il- pazjenti għandhom jirċievu kalċju u/ jew vitamina D supplimentari jekk l- ammont li jkunu qed jieħdu fid- dieta ma jkunx biżżejjed (ara sezzjoni 4. 4 u sezzjoni 4. 5).
Special Populations Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/ min.
Popolazzjonijiet speċjali Pazjenti b’ indeboliment tal- kliewi Ma hu meħtieġ l- ebda tibdil fid- doża għal pazjenti b’ indeboliment ħafif jew moderat tal- kliewi meta t - tneħħija tal- krejatinina hija 30 ml/ min jew aktar.
Bondenza 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).
Bondenza mhux irrakkomandat għal pazjenti bi tneħħija tal- krejatinina taħt 30 ml/ min minħabba esperjenza klinika limitata (ara sezzjoni 4. 4 u sezzjoni 5. 2)
2 Patients with hepatic impairment No dose adjustment is required (see section 5.2).
2 Pazjenti b’ indeboliment tal- fwied L- ebda tibdil fid- doża ma huwa meħtieġ (ara sezzjoni 5. 2).
Elderly Population No dose adjustment is required (see section 5.2).
Popolazzjoni Anzjana L- ebda tibdil fid- doża ma huwa meħtieġ (ara sezzjoni 5. 2)
Paediatric Population There is no relevant use of Bondenza in children, and Bondenza was not studied in the paediatric population.
Popolazzjoni Pedjatrika M’ hemm l- ebda użu rilevanti ta ’ Bondenza fit- tfal, u Bonviva ma kienx studjat fil- popolazzjoni pedjatrika.
Method of Administration:
Metodu ta ’ kif għandu jingħata:
For oral use.
Għall- użu orali
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.
Il- pilloli għandhom jinbelgħu sħaħ ma ’ tazza ilma waħdu (180 sa 240 ml) waqt li l- pazjent ikun bil - qiegħda jew bilwieqfa f’ pożizzjoni dritta.
Patients should not lie down for 1 hour after taking Bondenza.
Il- pazjenti m’ għandhomx jimteddu għal siegħa wara li jieħdu Bonviva.
Plain water is the only drink that should be taken with Bondenza.
Ilma waħdu huwa l- uniku xorb li għandu jittieħed ma ’ Bonviva.
Please note that some mineral waters may have a higher concentration of calcium and therefore, should not be used.
Jekk jogħġbok innota li ċerti ilmijiet minerali jista ’ jkollhom konċentrazzjoni akbar ta ’ kalċju u għalhekk, m’ għandhomx jintużaw.
Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration.
Il- pazjenti m’ għandhomx jomogħdu jew isoffu l- pillola, minħabba l- potenzjal għal ulċerazzjoni orofarinġali.
- Hypocalcaemia (see section 4.4)
- Ipokalċimja (ara sezzjoni 4. 4).
- Hypersensitivity to ibandronic acid or to any of the excipients.
- Sensittività eċċessiva għal ibandronic acid jew għal xi sustanzi mhux attivi.
Gastrointestinal Disorders Bisphosphonates have been associated with dysphagia, oesophagitis and oesophageal or gastric ulcers.
Disturbi Gastro- intestinali Bisphosphonates kienu assoċjati ma ’ disfaġija, esofaġite u ulċeri esofagali jew gastriċi.
Therefore patients, especially those with a history of prolonged oesophageal transit time, should pay particular attention to and be able to comply with the dosing instructions (see section 4.2).
Għalhekk pazjenti, speċjalment dawk b’ passat ta ’ ħin ta ’ transizzjoni esofagali mtawwal, għandhom jagħtu attenzjoni speċjali għal u jkunu kapaċi jsegwu l- istruzzjonijiet tad- dożaġġ (ara sezzjoni 4. 2).
Physicians should be alert to signs or symptoms signalling a possible oesophageal reaction during therapy, and patients should be instructed to discontinue Bondenza and seek medical attention if they develop symptoms of oesophageal irritation such as new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn.
It- tobba għandhom joqgħodu attenti għal sinjali jew sintomi li jindikaw il- possibbiltà ta ’ reazzjoni esofagali waqt it- terapija, u l- pazjenti għandhom jingħataw istruzzjonijiet biex iwaqqfu Bondenza u jfittxu attenzjoni medika jekk jiżviluppaw sintomi ta ’ irritazzjoni esofagali bħal ma huma disfaġija jew disfaġja li qed tmur għall- agħar, uġigħ meta jibilgħu, uġigħ retrosternali, jew ħruq ta ’ istonku.
Since Nonsteroidal Anti-Inflamatory Drugs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Peress li Mediċini Anti- Infjammatorji mhux Sterojdi u bisphosphonates it- tnejn, huma assoċjati ma ’ rritazzjoni gastro- intestinali, għandha tingħata attenzjoni waqt għoti flimkien.
Hypocalcaemia Existing hypocalcaemia must be corrected before starting Bondenza therapy.
Ipokalċimja Ipokalċimja eżistenti għandha tiġi kkorreġuta qabel tinbeda terapija b’ Bonviva.
Other disturbances of bone and mineral metabolism should also be effectively treated.
Disturbi oħra tal - metaboliżmu ta ’ l- għadam u l- minerali ukoll għandhom jiġu kkurati b’ mod effettiv.
Adequate intake of calcium and vitamin D is important in all patients.
Konsum adegwat ta ’ kalċju u vitamina D huwa importanti għall- pazjenti kollha.
Renal impairment Due to limited clinical experience, Bondenza is not recommended for patients with a creatinine clearance below 30 ml/ min (see section 5.2).
Indeboliment renali Minħabba esperjenza klinika limitata, Bonviva mhux irrakkomandat għal pazjenti bi tneħħija tal - krejatinina taħt 30ml/ min (ara sezzjoni 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.
Osteonekrosi tax- xedaq Osteonekrosi tax- xedaq, ġeneralment assoċjata mal- qlugħ ta ’ sinna u/ jew infezzjoni lokali (inkluż osteomijelite) kienet irrappurtata f’ pazjenti bil- kanċer li qed jirċievu korsijiet ta ’ kura inkluż primarjament bisphosphonates mogħtija minn ġol- vini.
Many of these patients were also receiving chemotherapy and corticosteroids.
Ħafna minn dawn il- pazjenti kienu qed jirċievu wkoll kimoterapija u kortikosterojdi.
Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
Osteonekrosi tax- xedaq kienet irrappurtata wkoll f’ pazjenti b’ osteoporożi li qed jirċievu bisphosphonates orali.
3 A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e. g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Eżami dentali b’ dentistrija ta ’ prevenzjoni xierqa għandha tiġi kkunsidrata qabel il- kura b’ bisphosphonates f’ pazjenti b’ fatturi ta ’ riskju fl- istess ħin (e. ż. kanċer, kimoterapija, radjuterapija, kortikosterojdi, iġene tal- ħalq ħażina).
While on treatment, these patients should avoid invasive dental procedures if possible.
3 Waqt il- kura, dawn il- pazjenti, jekk possibli, għandhom jevitaw proċeduri dentali invasivi.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Għall - pazjenti li jiżviluppaw osteonekrożi tax- xedaq waqt fuq terapija ta ’ bisphosphonate, kirurġija dentali tista ’ tagħmel din il- kundizzjoni agħar.
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Għall- pazjenti li jinħtieġu proċeduri dentali, m’ hemmx tagħrif disponibbli biex jissuġġerixxi jekk twaqqif tal- kura b’ bisphosphonate jnaqqasx ir- riskju ta ’ osteonekrosi tax- xedaq.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Ġudizzju kliniku mit- tabib li qed jikkura għandu jiggwida il- pjan ta ’ mmaniġġjar ta ’ kull pazjent ibbażat fuq analiżi individwali tal- benefiċċju/ riskju.
Galactose intolerance Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicinal product.
Intolleranza għal galactose Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, defiċjenza Lapp lactase jew assorbiment ħażin ta ’ glucose- galactose m’ għandhomx jieħdu dan il- prodott mediċinali.
Oral bioavailability of ibandronic acid is generally reduced in the presence of food.
Il- bijodisponibiltà ’ ta ’ ibandronic acid meta jittieħed mill- ħalq ġeneralment tonqos fil- preżenza ta ’ l - ikel.
In particular, products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk, are likely to interfere with absorption of Bondenza, which is consistent with findings in animal studies.
B’ mod partikolari, prodotti li fihom il- kalċju jew ketajins oħra multivalenti (bħall- aluminju, l - magneżju u l- ħadid), inkluż il- ħalib, x’ aktarx jinterferixxu mal- assorbiment ta ’ Bondenza, u dan huwa konsistenti ma ’ sejbiet fl- istudji fuq l- annimali.
Therefore, patients should fast overnight (at least 6 hours) before taking Bondenza and continue fasting for 1 hour following intake of Bondenza (see section 4.2).
Għalhekk, il- pazjenti għandhom isumu matul il- lejl (mill- inqas 6 sigħat) qabel ma jieħdu Bondenza u jkomplu jsumu għal siegħa wara t- teħid ta ’ Bondenza (ara sezzjoni 4. 2).
Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Bondenza.
Supplimenti tal- kalċju, antaċidi u xi prodotti mediċinali li jittieħdu mill- ħalq li fihom ketajins multivalenti (bħall- aluminju, l- magneżju u l- ħadid) x’ aktarx li jinterferixxu mal- assorbiment ta ’ Bondenza.
Therefore, patients should not take other oral medicinal products for at least 6 hours before taking Bondenza and for 1 hour following intake of Bondenza.
Għalhekk, il- pazjenti m’ għandhomx jieħdu prodotti mediċinali oħra li jittieħdu mill- ħalq għal mill- inqas 6 sigħat qabel ma jieħdu Bondenza u għal siegħa wara li jieħdu Bondenza.
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.
Interazzjonijiet metaboliċi mhux ikkunsidrati bħala probabbli peress li ibandronic acid ma jinibixxix l- isoenzimi P450 maġġuri umani tal- fwied u ntwera li ma jinduċix is- sistema taċ- ċitokromju P450 tal - fwied fil- firien.
Furthermore, plasma protein binding 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.
Barra minn hekk, it- twaħħil mal- proteini fil- plażma huwa madwar 85% - 87% (determinat in vitro f’ konċentrazzjonijiet terapewtiċi ta ’ mediċini), u għalhekk hemm possibbiltà baxxa li jkun hemm interazzjonijiet ma ’ prodotti mediċinali oħra minħabba spostament.
Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation.
Ibandronic acid huwa eliminat biss permezz ta ’ eskrezzjoni mill- kliewi u ma jkollu l- ebda biotrasformazzjoni.
The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other active substances.
Il - mogħdija tas- sekrezzjoni tidher li ma tinkludix sistemi ta ’ trasport aċidużi jew bażiċi magħrufa li huma involuti fl- eskrezzjoni ta ’ sustanzi attivi oħra.
In a two-year study in postmenopausal women with osteoporosis (BM 16549), the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking ibandronic acid 2.5 mg daily or 150 mg once monthly after one and two years.
Fi studju ta ’ sentejn f’ nisa wara l- menopawża b’ osteoprożi (BM 16549), l- inċidenza ta ’ avvenimenti gastro- intestinali ta ’ fuq, wara sena u sentejn, f’ pazjenti li qed jieħdu aspirina jew NSAIDs fl- istess waqt kienet simili f’ pazjenti li qed jieħdu ibandronic acid 2. 5 mg kuljum jew 150 mg darba fix- xahar.
Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% and 18% of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively.
Fost aktar minn 1500 pazjent imdaħħla fl- istudju BM 16549 li qabbel korsijiet ta ’ dożaġġ ta ’ ibandronic acid ta ’ kull xahar ma ’ dożaġġ ta ’ kuljum, 14% u 18% tal- pazjenti wżaw imblokkaturi ta ’ histamine (H2) jew inibituri tal- pompi tal- protoni wara sena u sentejn, rispettivament.
Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bondenza 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Fost dawn il - pazjenti, l- inċidenza ta ’ avvenimenti gastro- intestinali ta ’ fuq fil- pazjenti kkurati b’ Bondenza 150 mg darba fix- xahar kienet simili għal dik f’ pazjenti kkurati b’ ibandronic acid 2. 5 mg kuljum.
In healthy male volunteers and postmenopausal women, intravenous administration of ranitidine caused an increase in ibandronic acid bioavailability of about 20%, probably as a result of reduced gastric acidity.
F’ voluntiera maskili b’ saħħithom u f’ nisa wara l- menopawża, l- għoti ta ’ ranitidine minn ġol- vina ikkawża żjieda ta ’ madwar 20% fil- bijodisponibiltà ta ’ ibandronic acid probabbilment bħala riżultat ta ’ tnaqqis ta ’ l- aċidità gastrika.
However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Bondenza is administered with H2- antagonists or other active substances which increase gastric pH.
Madankollu, peress li din iż- żjieda taqa ’ fil- varjabilità normali tal - bijodisponibiltà ta ’ ibandronic acid, l- ebda tibdil fid- doża ma huwa kkunsidrat meħtieġ meta Bonviva jingħata flimkien ma ’ antagonisti ta ’ H2 jew ma ’ sustanzi attivi oħrajn li jżiedu l- pH gastrika.
Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (oestrogen).
Studji dwar l- interazzjoni farmakokinetika f’ nisa wara l- menopawża wrew li m’ hemm l- ebda potenzjal ta ’ interazzjoni ma ’ tamoxifen jew ma ’ terapija ta ’ sostituzzjoni ta ’ l- ormoni (oestrogen).
No interaction was observed when co-administered with melphalan/ prednisolone in patients with multiple myeloma.
Ma kienet osservata l- ebda interazzjoni meta ingħata flimkien ma ’ melphalan/ prednisolone f’ pazjenti b’ majeloma multipla.
4 4.6 Pregnancy and lactation
4 4. 6 Tqala u Treddigħ
Pregnancy There are no adequate data from the use of ibandronic acid in pregnant women.
Tqala M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ ibandronic acid waqt it- tqala.
Studies in rats have shown some reproductive toxicity (see section 5.3).
Studji fuq il- firien urew xi ħsara fuq is- sistema riproduttiva (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju li jista jkun hemm fuq in- nies, mhux magħruf.
Bondenza should not be used during pregnancy.
Bondenza m’ għandux jintuża waqt it- tqala.
Lactation It is not known whether ibandronic acid is excreted in human milk.
Treddigħ M’ huwiex magħruf jekk ibandronic acid jitneħħiex fil- ħalib uman.
Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration.
Studji fuq il- firien li qed ireddgħu wrew il- preżenza ta ’ livelli baxxi ta ’ ibandronic acid fil- ħalib wara għoti minn ġol- vina.
Bondenza should not be used during lactation.
Bondenza m’ għandux jintuża waqt it- treddigħ
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq u tħaddem magni
The safety of ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo- controlled clinical studies; 73% of these patients came from the pivotal three-year treatment study (MF 4411).
Is- sigurtà ta ’ ibandronic acid 2. 5 mg kuljum kienet stmata f’ 1251 pazjent ikkurati f’ 4 studji kliniċi kontrollati bil- plaċebo; 73% minn dawn il- pazjenti ġew mill- istudju pivotali ta ’ tliet snin ta ’ kura (MF 4411).
The overall safety profile of ibandronic acid 2.5 mg daily in all these studies was similar to that of placebo.
Il- profil globali tas- sigurtà ta ’ ibandronic acid 2. 5 mg kuljum f’ dawn l- istudji kollha kien simili għal dak tal- plaċebo.
The overall proportion of patients who experienced an adverse reaction, i. e. adverse event with a possible or probable relationship to trial medication, in the pivotal treatment study (MF 4411) was 19.8% for ibandronic acid and 17.9% for placebo.
Il- proporzjoni globali ta ’ pazjenti li kellhom esperjenza ta ’ reazzjoni avversa tal - mediċina, i. e. reazzjoni avversa b’ possibbiltà jew probabbiltà ta ’ relazzjoni mal- mediċina taħt prova, fl- istudju pivitali tal- kura (MF 4411) kien ta ’ 19. 8% għal ibandronic acid u 17. 9% għal plaċebo.
In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Bondenza 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
Fi studju ta ’ sentejn f’ nisa wara l- menopawża b’ osteoprożi (BM 16549), is- sigurtà globali ta ’ Bondenza 150 mg darba fix- xahar u ibandronic acid 2. 5 mg kuljum kienet simili.
The overall proportion of patients who experienced an adverse reaction, was 22.7% and 25.0% for Bondenza 150 mg once monthly and 21.5% and 22.5% for ibandronic acid 2.5 mg daily after one and two years, respectively.
Il- proporzjon globali ta ’ pazjenti li kellhom esperjenza ta ’ reazzjoni avversa, kien 22. 7% u 25. 0% għal Bondenza 150 mg darba fi- xahar u 21. 5% u 22. 5% għal ibandronic acid 2. 5 mg kuljum wara sena u sentejn, rispettivament.
The majority of adverse reactions were mild to moderate in intensity.
Il- maġġoranza ta ’ reazzjonijiet avversi kienu ħfif għal moderati fl- intensità tagħhom.
Most cases did not lead to cessation of therapy.
Il- biċċa l- kbira tal- każijiet ma wasslux għall- waqfien tat- terapija.
Table 1 and table 2 list adverse reactions occurring in more than 1% of patients treated with Bondenza 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.
Tabella 1 u tabella 2 iniżżlu reazzjonijiet avversi li seħħew f’ iżjed minn 1% tal- pazjenti kkurati b’ Bondenza 150 mg darba fix- xahar jew 2. 5 mg kuljum fl- istudju BM 16549, u f’ pazjenti kkurati b’ ibandronic acid 2. 5 mg kuljum fl- istudju MF 4411.
The tables show the adverse reactions in the two studies that occurred with a higher incidence than in patients treated with placebo in study MF 4411.
It- tabelli juru r- reazzjonijiet avversi fiż- żewġ studji li seħħew b’ inċidenza ogħla minn dik f’ pazjenti kkurati bil- plaċebo fl- istudju MF 4411.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
Data at one year from BM 16549 are represented in Table 1 and cumulative data for the two years from BM 16549 are represented in table 2.
Tagħrif wara sena minn BM 16549 huwa rrappreżentat f’ Tabella 1 u tagħrif kumulattiv ta ’ sentejn minn BM 16549 huwa rrappreżentat f’ tabella 2.
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
Reazzjonijiet avversi tal- mediċina komuni (> 1/ 100, ≤ 1/ 10) fi studji ta ’ fażi III dwar l - osteoporożi, li kienu kkunsidrati mill- investigatur bħala possibilment jew probabbilment relatati mal - kura – Tagħrif ta ’ sena mill- istudju BM 16549 u tagħrif ta ’ tliet snin mill- istudju ikkontrollat bil - plaċebo dwar ksur MF 4411
One year data in study BM 16549
Tagħrif ta ’ sena fl- istudju BM 16549
Three year data in study MF 4411
Tagħrif ta ’ tliet snin fl- istudju MF 4411
System Organ Class/ Adverse reaction Gastrointestinal system
Sistema tal - klassifika tal -
Bondenza 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
Bondenza 150 mg ibandronic acid darba fix- xahar 2. 5 mg kuljum
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
ibandronic acid Plaċebo 2. 5 mg kuljum (N=975)
Gastro-oesophageal reflux disease
Organi/ Reazzjoni
0.5 1.0
(N=396) (N=395)
0.4 0.1
(N=977) (%)
Diarrhoea
(%) (%)
2.5 1.8
(%)
1.4 1.0
0. 5 1. 0
System Organ Class/ Adverse reaction
Bondenza 150 mg darba fix- xahar
Bondenza 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
ibandronic acid 2. 5 mg kuljum
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
ibandronic acid 2. 5 mg kuljum
Abdominal pain Dyspepsia Nausea Flatulence Nervous system
Dijarea Uġigħ addominali Dispepsja Tqalligħ Gass fl- istonku Sistema Nervuża
3.5 2.8 3.3 5.8 3.3 3.5 0.5 1.0
1. 8 2. 8 5. 8 3. 5 1. 0
2.1 2.9 4.3 2.9 1.8 2.3 0.4 0.7
1. 4 2. 1 4. 3 1. 8 0. 4
Headache General disorders
Uġigħ ta ’ ras Disturbi ġenerali
0.8 1.5
0. 3
0.8 0.6
0. 2
Influenza like illness* Fatigue Musculoskeletal system
Għeja Sistema muskolu - skeltrali
3.3 0.3 1.0 0.3
1. 0
0.3 0.2 0.3 0.4
0. 4
Arthralgia Myalgia Skin disorders
Atralġja Mijalġja Disturbi fil- ġilda
1.0 0.3 1.5 0.3
1. 0 1. 5
0.4 0.4 1.8 0.8
0. 4 1. 8
Rash MedDRA version 6.1
Raxx MedDRA versjoni 6. 1
0.8 1.0
1. 0
1.2 0.7
0. 7
* Transient, influenza-like symptoms have been reported with Bondenza 150 mg once monthly, typically in association with the first dose.
* Sintomi temporanji, li jixbħu lill- influwenza ġew irrappurtati b’ Bondenza 150 mg darba fix- xahar, tipikament assoċjati ma ’ l- ewwel doża.
Such symptoms were generally of short duration, mild or moderate in intensity, and resolved during continuing treatment without requiring remedial measures.
Sintomi bħal dawn kienu ġeneralment ta ’ tul qasir, ta ’ intensità ħafifa jew moderata, u fiequ waqt li tkompliet il- kura mingħajr il- ħtieġa ta ’ miżuri ta ’ fejqan.
Influenza-like illness includes events reported as acute phase reaction or symptoms including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, or bone pain.
Marda li tixbaħ lill- influwenza tinkludi avvenimenti rrappurtati bħala reazzjoni ta ’ fażi akuta jew sintomi inkluż mijalġja, artralġja, deni, rogħda, għeja, tqalligħ, telf ta ’ aptit, jew uġigħ fl- għadam.
Cumulative 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 - Two year data from study BM 16549 and three year data from placebo-controlled fracture study MF 4411
Reazzjonijiet avversi tal- mediċina komuni, kumulattivi (> 1/ 100, ≤ 1/ 10) fi studji ta ’ Fażi III dwar l- osteoporożi, li kienu kkunsidrati mill- investigatur bħala possibilment jew probabbilment relatati mal- kura – Tagħrif ta ’ sentejn mill- istudju BM 16549 u tagħrif ta ’ tliet snin mill- istudju ikkontrollat bil- plaċebo dwar ksur MF 4411
Two year cumulative data in study BM 16549
Tagħrif kumulattiv ta ’ sena fl- istudju BM 16549
Three year data in study MF 4411
Tagħrif ta ’ tliet snin fl- studju MF 4411
System Organ Class/ Adverse reaction Gastrointestinal system
Sistema tal- klassifika ta ’ l- Organi/ Reazzjoni avversa Sistema gastro - intestinali
Bondenza 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
Bondenza 150 mg ibandronic acid darba fix- xahar 2. 5 mg kuljum (N=396) (N=395) (%) (%)
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
ibandronic acid Plaċebo 2. 5 mg kuljum (N=975) (N=977) (%) (%)
Gastritis Gastro-oesophageal reflux disease
Gastrite Marda ta ’ rifluss gastro- esofagali
0.3 0.2
0. 7 0. 5 0. 5 0. 1
Muscle cramp Musculoskeletal pain Arthralgia
Esofaġite Dijarea Uġigħ addominali Dispepsja Tqalligħ Sistema Nervuża
0.5 1.0 1.0 0.5 1.0 0.5
0 1. 0 2. 5 2. 0 4. 0 3. 0 4. 0 6. 3 3. 0 3. 5
0.1 0.4 0 0 0.4 0.4
0. 5 0. 4 1. 4 1. 0 2. 1 2. 9 4. 0 2. 7 1. 8 2. 3
6
0. 8 0. 6
Two year cumulative data in study BM 16549
Marda li tixbaħ lill - influwenza *
Three year data in study MF 4411
0. 3 0. 2
System Organ Class/ Adverse reaction
6 Sistema tal- klassifika ta ’ l- Organi/ Reazzjoni avversa Sistema muskolu - skeltrali
Bondenza 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
Tagħrif kumulattiv ta ’ sena fl- istudju BM 16549 Bondenza 150 mg ibandronic acid 2. 5 mg kuljum darba fix- xahar (N=395) (N=396) (%) (%)
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
Tagħrif ta ’ tliet snin fl- studju MF 4411 Plaċebo ibandronic acid (N=975) 2. 5 mg kuljum (%) (N=977) (%)
Myalgia Musculoskeletal stiffness Skin disorders
Bugħawwieġ Uġigħ muskolu - skeltrali
1.5 0.3 1.0 0
0. 5 1. 0 1. 0 0. 5
1.8 0.8 0 0
0. 4 0. 4 1. 8 0. 8 0 0
Rash MedDRA version 7.1
Raxx MedDRA versjoni 7. 1
Adverse reactions occurring at a frequency of less than or equal to 1%
Reazzjonijiet avversi li jseħħu bi frekwenza ta ’ 1% jew inqas
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 Bondenza 150 mg once monthly than with ibandronic acid 2.5 mg daily.
Il- lista ta ’ hawn taħt tipprovdi informazzjoni dwar reazzjonijiet avversi li ġew irrappurtati fl- istudju MF 4411 li seħħew bi frekwenza akbar b’ ibandronic acid 2. 5 mg kuljum milli bil- plaċebo, u fl- studju BM 16549 li seħħew bi frekwenza akbar b’ Bondenza 150 mg darba fix- xahar milli b’ ibandronic acid 2. 5 mg kuljum.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
L- effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji:
Uncommon (1/ 100 – 1/ 1,000) Gastro-intestinal Disorders:
Mhux komuni (1/ 100 – 1/ 1000) Disturbi Gastro- intestinali:
gastritis, oesophagitis including oesophageal ulcerations or strictures, vomiting, dysphagia
gastrite, esofaġite inkluż ulċerazzjonijiet jew kontrazzjonijiet esofagali, rimettar, disfaġija
Musculoskeletal and Connective Tissue Disorders:
Disturbi fis- Sistema Nervuża: sturdament Disturbi Muskolu- skeltrali u tal- Connective Tissue: uġigħ fid- dahar
Rare (1/ 1,000 – 1/ 10,000)
Rari (1/ 1000 – 1/ 10, 000) Disturbi Gastro- intestinali:
Immune System Disorders:
duwodenite
duodenitis hypersensitivity reactions angioedema, face oedema, urticaria
Disturbi fis- Sistema Immuni: reazzjonijiet ta ’ sensittività eċċessiva Disturbi fil- Ġilda u fit- Tessuti ta ’ taħt il - Ġilda: anġjoedima, edima tal- wiċċ, urtikarja
Patients with a previous history of gastrointestinal disease including patients with peptic ulcer without recent bleeding or hospitalisation, and patients with dyspepsia or reflux controlled by medication were included in the once monthly treatment study.
Pazjenti b’ passat minn qabel ta ’ mard gastro- intestinali inkluż pazjenti b’ ulċera peptika mingħajr fsada reċenti jew dħul l- isptar, u pazjenti b’ dispepsja jew rifluss ikkontrollat permezz ta ’ medikazzjoni kienu inklużi fl- istudju ta ’ kura ta ’ darba fix- xahar.
For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150 mg once monthly regimen compared to the 2.5 mg daily regimen.
Għal dawn il- pazjenti, ma kien hemm l- ebda differenza fl- inċidenza ta ’ avvenimenti avversi fil- parti gastro- intestinali ta ’ fuq bil- kors ta ’ 150 mg darba fix- xahar meta mqabbel mal- kors ta ’ 2. 5 mg kuljum.
Laboratory test findings In the pivotal three-year study with ibandronic acid 2.5 mg daily (MF 4411) there was no difference compared with placebo for laboratory abnormalities indicative of hepatic or renal dysfunction, an impaired haematologic system, hypocalcaemia or hypophosphataemia.
Sejbiet minn testijiet tal- laboratorju Fl- istudju pivotali ta ’ tliet snin b’ ibandronic acid 2. 5 mg kuljum (MF 4411), ma kien hemm l- ebda differenza fl- anormalitajiet tal- laboratorju indikattivi għal funzjoni epatika jew tal- kliewi ħażina, sistema ematoloġika indebolita, ipokalċimja jew ipofosfatimja, meta mqabbel mal- plaċebo.
Similarly, no differences were noted between the groups in study BM 16549 after one and two years.
Bl- istess mod, ma kienet osservata l- ebda differenza bejn il- gruppi fl- istudju BM 16549 wara sena u sentejn.
Post-marketing Experience Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Esperjenza ta ’ Wara t- Tqegħid fis- Suq Osteonekrosi tax- xedaq kienet irrappurtata f’ pazjenti kkurati b’ bisphosphonates.
The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Il- maġġoranza tar - rapporti jirreferu għall- pazjenti bil- kanċer, iżda każijiet bħal dawn kienu rrappurtati wkoll f’ pazjenti
Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
Osteonekrosi tax- xedaq huwa ġeneralment assoċjat mal- qlugħ ta ’ sinna u / jew infezzjoni lokali (inkluż osteomijelite).
Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
Dijanjosi tal- kanċer, kimoterapija, radjuterapija, koritikosterojdi u iġene orali ħażina wkoll huma meqjusa bħala fatturi ta ’ riskju (ara sezzjoni 4. 4).
7 4.9 Overdose
4. 9 Doża eċċessiva
No specific information is available on the treatment of over dosage with Bondenza.
L- ebda informazzjoni speċifika ma hija disponibbli dwar il- kura ta ’ doża eċċessiva ta ’ Bondenza.
However, based on a knowledge of this class of compounds, oral over-dosage may result in upper gastrointestinal adverse reactions (such as upset stomach, dyspepsia, oesophagitis, gastritis, or ulcer) or hypocalcaemia.
Madankollu, ibbażat fuq tagħrif dwar din il- klassi ta ’ sustanzi, doża eċċessiva meħuda mill- ħalq tista ’ tirriżulta f’ reazzjonijiet avversi gastro- intestinali fil- parti ta ’ fuq (bħal taqlib fl- istonku, dispepsja, esofaġite, gastrite, jew ulċera) jew ipokalċimja.
Milk or antacids should be given to bind Bondenza, and any adverse reactions treated symptomatically.
Ħalib jew antaċidi għandhom jingħataw biex jeħlu ma ’ Bondenza, u kull reazzjoni avversa għandha tiġi kkurati skond is- sintomi.
Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Minħabba r- riskju ta ’ irritazzjoni esofagali, m’ għandux jiġi indott r- rimettar u l- pazjent għandu jibqa ’ f’ pożizzjoni kompletament wieqfa.
Bisphosphonates, ATC code:
Bisphosphonates, kodiċi ATC:
Mechanism of action Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act selectively on bone tissue and specifically inhibit osteoclast activity without directly affecting bone formation.
Mekkaniżmu ta ’ azzjoni Ibandronic acid huwa bisphosphonate potenti ħafna li jagħmel parti mill- grupp ta ’ bisphosphonates li fihom n- nitroġenu, li jaġixxi b’ mod selettiv fuq it- tessut ta ’ l- għadam u jinibixxi speċifikament l - attività osteoklastika mingħajr ma jaffettwa direttament il- formazzjoni ta ’ l- għadam.
It does not interfere with osteoclast recruitment.
Ma jinterferixxix mar- reklutaġġ osteoklastiku.
Ibandronic acid leads to progressive net gains in bone mass and a decreased incidence of fractures through the reduction of elevated bone turnover towards premenopausal levels in postmenopausal women.
Ibandronic acid iwassal għal żidiet progressivi netti fil- massa ta ’ l - għadam u għall- inċidenza mnaqqsa ta ’ ksur billi jnaqqas it- tibdil elevat ta ’ l- għadam lejn livelli ta ’ qabel il- menopawża f’ nisa wara l- menopawża.
Pharmacodynamic effects The pharmacodynamic action of ibandronic acid is inhibition of bone resorption.
Effetti farmakodinamiċi L- azzjoni farmakodinamika ta ’ ibandronic acid hija l- inibizzjoni ta ’ assorbiment mill- ġdid tal- għadam.
In vivo, ibandronic acid prevents experimentally induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.
In vivo, ibandronic acid jipprevjeni id- distruzzjoni ta ’ l- għadam indotta bl- esperimenti permezz ta ’ waqfien tal- funzjoni gonadali, retinojdi, tumuri jew estratti tat- tumur.
In young (fast growing) rats, the endogenous bone resorption is also inhibited, leading to increased normal bone mass compared with untreated animals.
F’ firien ta ’ età żgħira (li jikbru malajr), l- assorbiment mill- ġdid endoġenu ta ’ l- għadam huwa wkoll inibit, u jwassal għal żjieda fil - massa normali ta ’ l- għadam meta mqabbel ma ’ annimali mhux ikkurati.
Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity.
Mudelli ta ’ l- annimali jikkonfermaw li ibandronic acid huwa inibitur qawwi ħafna ta ’ l- attività osteoklastika.
In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment.
F’ firien li kienu qed jikbru, ma kien hemm l- ebda evidenza ta ’ tnaqqis fil - mineralizzazjoni anki f’ dożi ta ’ aktar minn 5, 000 darba akbar mid- doża meħtieġa għall- kura ta ’ l - osteoporożi.
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.
L- għoti għall- perijodu twil, kemm kuljum kif ukoll b’ mod intermittenti (b’ intervalli mtawwla bla doża) lill- firien, klieb u xadini kien assoċjat mal- formazzjoni ta ’ għadam ġdid ta ’ kwalità normali u saħħa mekkanika miżmuma jew miżjuda anki b’ dożi fi skala tossika.
In humans, the efficacy of both daily and intermittent administration with a dose-free interval of 9-10 weeks of ibandronic acid was confirmed in a clinical trial (MF 4411), in which ibandronic acid demonstrated anti-fracture efficacy.
Fil- bnedmin, kemm l- effikaċja ta ’ għotja kuljum kif ukoll dik ta ’ għotja intermittenti b’ intervall bla doża ta ’ 9- 10 ġimgħat ta ’ ibandronic acid, kienet ikkonfermata fi prova klinika (MF 4411), fejn ibandronic acid wera effikaċja kontra l- ksur.
In animal models ibandronic acid produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including suppression of urinary biochemical markers of bone collagen degradation (such as deoxypyridinoline, and cross-linked N-telopeptides of type I collagen (NTX)).
F’ mudelli ta ’ l- annimali Ibandronic acid ipproduċa bidliet biokimiċi li jindikaw inibizzjoni tal - assorbiment mill- ġdid ta ’ l- għadam li tiddependi fuq id- doża, inkluż soppressjoni ta ’ markaturi biokimiċi tad- degradazzjoni tal- kollaġen ta ’ l- għadam (bħal deoxypyridinoline, u cross linked N - telopeptides ta ’ kollaġen tat- tip I (NTX).
In a Phase 1 bioequivalence study conducted in 72 postmenopausal women receiving 150 mg orally every 28 days for a total of four doses, inhibition in serum CTX following the first dose was seen as early as 24 hours post-dose (median inhibition 28%), with median maximal inhibition (69%) seen 6 days later.
Fi studju ta ’ bioekwivalenza ta ’ Fażi I imwettaq f’ 72 mara wara l- menopawża li kienu qed jirċievu 150 mg orali kull 28 ġurnata għal total ta ’ erba ’ dożi, kienet osservata inibizzjoni fis- CTX tas- serum wara l- ewwel doża sa minn 24 siegħa wara d- doża (inibizzjoni medjana ta ’ 28%), b’ inibizzjoni medjana massima (69%) osservata 6 ijiem wara.
Following the third and fourth dose, the median maximum inhibition 6 days post dose was 74% with reduction to a median inhibition of 56% seen 28 days following the fourth dose.
Wara t- tielet u r- raba ’ doża, l- inibizzjoni medjana massima 6 ijiem wara d- doża kienet ta ’ 74%, bi tnaqqis għal inibizzjoni medjana ta ’ 56% osservata 28 ġurnata wara r- raba ’ doża.
With no further dosing, there is a loss of suppression of biochemical markers of bone resorption.
Meta ma jkunx hemm aktar għoti ta ’ doża, ikun hemm telf tas - soppressjoni tal- markaturi biokimiċi ta ’ l- assorbmient mill- ġdid ta ’ l- għadam.
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 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 150 mg once monthly
Bondenza 150 mg darba fix- xahar
8 Bone mineral density (BMD) Bondenza 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).
Densità tal- minerali ta ’ l- għadam (BMD) Fi studju ta ’ ħafna ċentri, double- blind, ta ’ sentejn (BM 16549) ta ’ nisa wara l- menopawża b’ osteoporożi (punteġġ T tal- BMD tas- sinsla lumbari taħt - 2. 5 SD fil- linja bażi), Bondenza 150 mg darba fix- xahar intwera li kien mill- inqas effettiv daqs ibandronic acid 2. 5 mg kuljum biex iżid il - BMD.
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).
One year data in study BM 16549
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 16549.
Two year data in study BM 16549
Tagħrif kumulattiv ta ’ wara Tagħrif ta ’ wara sena fl- istudju sentejn fl- istudju BM 16549 BM 16549 Bidliet relattivi medji mil -
Mean relative changes from baseline% [95% CI]
linja bażi% [95% CI]
ibandronic acid Bondenza 2.5 mg daily 150 mg once (N=318) monthly (N=320)
2. 5 mg kuljum
ibandronic acid Bondenza 2.5 mg daily 150 mg once (N=294) monthly (N=291)
2. 5 mg kuljum
Lumbar spine L2-L4 BMD
Sinsla lumbari L2- L4 BMD
Total hip BMD
BMD totali tal- ġembejn
Femoral neck BMD
BMD tal- għonq tal- wirk
Trochanter BMD
BMD tat- trokanter
Furthermore, Bondenza 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.
Barra minn hekk, f’ analiżi prospettiva ippjanata ma ’ l- ewwel sena, p=0. 002, u mas- sentejn, p < 0. 001, ġie ppruvat li Bondenza 150 mg darba fix- xahar kien superjuri għal ibandronic acid 2. 5 mg kuljum biex iżid il- BMD tas- sinsla lumbari.
At one year (primary analysis), 91.3% (p=0.005) of patients receiving Bondenza 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.
Ma ’ l- ewwel sena (analiżi primarja), 91. 3% (p=0. 005) tal- pazjenti li kienu qed jirċievu Bondenza 150 mg darba fix- xahar kellhom żieda fil- BMD tas- sinsla lumbari ’ l fuq jew daqs il- linja bażi (dawk li rrispondew għal BMD), meta mqabbel ma ’ 84. 0% tal- pazjenti li kienu qed jirċievu ibandronic acid 2. 5 mg kuljum.
At two years, 93.5% (p=0.004) and 86.4% of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Mas- sentejn, 93. 5% (p=0. 004) u 86. 4% tal- pazjenti li kienu qed jirċievu Bondenza 150 mg darba fix- xahar jew ibandronic acid 2. 5 mg kuljum, rispettivament, kienu dawk li rrispondew.
For total hip BMD, 90.0% (p < 0.001) of patients receiving Bondenza 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.
Għal BMD totali tal- ġembejn, 90. 0% (p < 0. 001) tal- pazjenti li kienu qed jirċievu Bondenza 150 mg darba fix- xahar u 76. 7% tal- pazjenti li kienu qed jirċievu ibandronic acid 2. 5 mg kuljum kellhom żieda fil- BMD totali tal- ġembejn ’ l fuq jew daqs il- linja bażi ma ’ l- ewwel sena.
At two years 93.4% (p < 0.001) of patients receiving Bondenza 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.
Mat- tieni sena 93. 4% (p < 0. 001) tal- pazjenti li kienu qed jirċievu Bondenza 150 mg darba fix- xahar u 78. 4%, tal- pazjenti li kienu qed jirċievu ibandronic acid 2. 5 mg kuljum kellhom żieda fil- BMD totali tal- ġembejn ’ l fuq jew daqs il- linja bażi.
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 Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Meta jkun ikkunsidrat kriterju aktar strett, li jikkombina kemm il- BMD tas- sinsla lumbari kif ukoll il - BMD totali tal- ġembejn, 83. 9% (p < 0. 001) u 65. 7% tal- pazjenti li kienu qed jirċievu Bondenza 150 mg darba fix- xahar jew ibandronic acid 2. 5 mg kuljum, rispettivament, kienu dawk li rrispondew
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.
Mat- tieni sena, 87. 1% (p < 0. 001) u 70. 5%, tal- pazjenti laħqu dan il- kriterju fil - gruppi ta ’ 150 mg kull xahar u 2. 5 mg kuljum rispettivament.
Biochemical markers of bone turn-over Clinically meaningful reductions in serum CTX levels were observed at all time points measured, i. e. months 3, 6, 12 and 24.
Markaturi biokimiċi tat- tibdil ta ’ l- għadam Tnaqqis ta ’ sinifikat kliniku fil- livelli fis- serum ta ’ CTX kienu osservati fil- punti kollha ta ’ ħin imkejjla, i. e. xhur 3, 6, 12 u 24.
After one year (primary analysis) the median relative change from baseline was -76% for Bondenza 150 mg once monthly and -67% for ibandronic acid 2.5 mg daily.
Wara sena (analiżi primarja) il- bidla medjana relattiva mil- linja bażi kienet - 76% għal Bondenza 150 mg darba fix- xahar u - 67% għal ibandronic acid 2. 5 mg kuljum.
At two years the median relative change was -68% and -62%, in the 150 mg monthly and 2.5 mg daily arms respectively.
Mat- tieni sena l- bidla medjana relattiva kienet - 68% u - 62%, fil- gruppi ta ’ 150 mg kull xahar u 2. 5 mg kuljum rispettivament.
At one year, 83.5% (p= 0.006) of patients receiving Bondenza 150 mg once monthly and 73.9% of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease
Ma ’ l- ewwel sena, 83. 5% (p= 0. 006) tal- pazjenti li kienu qed jirċievu Bondenza 150 mg darba fix - xahar u 73. 9% tal- pazjenti li kienu qed jirċievu ibandronic acid 2. 5 mg kuljum kienu identifikati bħala dawk li rrispondew (definit bħala tnaqqis ta ’ ≥50% mil- linja bażi).
At two years 78.7% (p=0.002) and 65.6% of patients were identified as responders in the 150 mg monthly and 2.5 mg daily arms respectively.
Mat- tieni sena 78. 7% (p=0. 002) u 65. 6% tal- pazjenti kienu identifikati bħala dawk li rrispondew fil- gruppi ta ’ 150 mg kull xahar u 2. 5 mg kuljum rispettivament.
Based on the results of study BM 16549, Bondenza 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily.
Ibbażat fuq ir- riżultati ta ’ l- istudju BM 16549, Bondenza 150 mg darba fix- xahar huwa mistenni li jkun minn ta ’ l- inqas effetiv daqs ibandronic acid 2. 5 mg kuljum biex jipprevjeni l- ksur.
Ibandronic acid 2.5 mg daily
Ibandronic acid 2. 5 mg kuljum