qanastek/EMEA-V3 huggingface dataset:
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.
L- osteonekrożi tax- xedaq, huwa ġeneralment assoċjat ma ’ l- estrazzjoni tas- snien u/ jew infezzjoni lokali (inkluż_ osteomijelite) ġie rapportat f’ pazjenti b’ kanċer li kienu qed jingħataw korsijiet ta ’ kura inkluż bisfosfonati primarji mogħtija ġol- vina.
Many of these patients were also receiving chemotherapy and corticosteroids.
Ħafna minn dawn il- pazjenti kienu qegħdin jirċievu l - kemjoterapija u kortikosterojdi.
Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
L- osteonekrożi tax- xedaq ġie rapportat f’ pazjenti li isoffru minn osteoporożi waqt li jirċievu bisfosfonati orali.
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).
Eżaminazzjoni dentali bid- dentistrija preventiva xierqa għandu jkun kkunsidrat qabel it- trattament b’ bisfosfonati f’ pazjenti li għandhom fatturi tar- riskju konkomittanti (per eżempju l- kanċer, il - kemjoterapija, ir- radjuterapija, kortikosterojdi, iġene orali batuta).
While on treatment, these patients should avoid invasive dental procedures if possible.
Jekk ikun possibbli dawn il- pazjenti għandhom jevitaw proċeduri dentali invażivi waqt it- trattment.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Għall- pazjenti li jiżvillupaw osteonekrożi fix- xedaq waqt li qegħdin jirċievu terapija bil- bisfosfonati, kirurġija dentali tista ’ tiggrava l- kundizzjoni.
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 jinħteġilhom proċeduri dentali, ma hemm l- ebda tagħrif disponibbli li jissuġerixxi jekk it- twaqqif tat- trattament bil- bisfosfonati tnaqqas ir- riskju ta ’ l- osteonekrożi tax- xedaq.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Id- deċiżjoni klinika tat- tabib li qed jikkura għandha tagħti direzzjoni għall- pjan ta ’ mmaniġġjar għal kull pazjent bbażat fuq stima tal- benefiċju/ riskju individwali.
Bondronat should not be mixed with calcium containing solutions
Bondronat ma għandux jitħallat ma ’ soluzzjonijiet li fihom il- kalċju
No interaction was observed when co-administered with melphalan/ prednisolone in patients with multiple myeloma.
4 Ma ġiet osservata l- ebda interazzjoni meta mogħtija flimkien ma ’ melphalan/ prednisolone f’ pazjenti b’ mijeloma multipla.
Other interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (oestrogen).
Studji oħra ta ’ interazzjoni f’ nisa li għaddew mill- menopawża ma urew l- ebda potenzjal għal interazzjoni ma ’ tamoxifen jew terapija ta ’ sostituzzjoni bl- ormoni (estroġenu).
4 In relation to disposition, no drug interactions of clinical significance are likely.
B’ relazzjoni mad- disposizzjoni, x’ aktarx li m’ hemm l- ebda interazzjoni ta ’ sinifikat kliniku.
Ibandronic acid is eliminated by renal secretion only and does not undergo any biotransformation.
Ibandronic acid jiġi eliminat mill- kliewi biss u ma jgħaddix minn biotrasformazzjoni.
The secretory pathway does not appear to include known acidic or basic transport systems involved in the excretion of otheractive substances.
Il- passaġġ li jnixxih ma jidhirx li jinkludi sistemi ta ’ trasport aċidużi jew alkalini li jinvolvu t- tneħħija ta ’ sustanzi attivi oħra.
In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Barra minn dan, ibandronic acid ma jwaqqafx l- isoenżimi maġġuri umani P450 tal- fwied u ma jinduċix is- sistema taċ- ċitokromju tal- fwied P450 fil- firien.
Plasma protein binding is low at therapeutic concentrations and ibandronic acid is therefore unlikely to displace other active substances.
Twaħħil ma’ proteini fil- plażma hija baxxa f’ konċentrazzjonijiet terapewtiċi u ibandronic acid x’ aktarx ma jissostitwix sustanzi attivi oħra.
Caution is advised when bisphosphonates are administered with aminoglycosides, since both agents can lower serum calcium levels for prolonged periods.
Wieħed għandu joqgħod attent meta jingħataw bisfosfonati ma ’ aminoglycosides, minħabba li ż- żewġ mediċinali jistgħu ibaxxu l- livelli ta ’ kalċju fis- serum għal perijodi twal.
Attention should also be paid to the possible existence of simultaneous hypomagnesaemia.
Għandha tingħata attenzjoni wkoll għal possibilità ta ’ esistenza ta ’ ipomanjesimja simultanja.
In clinical studies, Bondronat has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Fi studji kliniċi, Bondronat ġie amministrat flimkien ma ’ aġenti użati b’ mod komuni kontra l- kanċer, dijuretiċi, antibijotiċi u analġesjiċi mingħajr ma ġraw interazzjonijiet kliniċi evidenti.
Interaction studies have only been performed in adults.
Studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott twettqu biss fl- adulti.
There are no adequate data from the use of ibandronic acid in pregnant women.
M’ hemmx tagħrif adegwata mill- użu ta ’ ibandronic acid fin- nisa tqal.
Studies in rats have shown reproductive toxicity (see section 5.3).
Studji fil- firien urew tossiċità riproduttiva (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju potenzjali fil- bnedmin għadu mhux magħruf.
Therefore, Bondronat should not be used during pregnancy.
Għalhekk, Bondronat m’ għandux jintuża waqt it- tqala.
It is not known whether ibandronic acid is excreted in human milk.
Għadu mhux magħruf jekk ibandronic acid jitneħħix fil- ħalib tal- bnedmin.
Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration.
Studji fuq firien li qed ireddgħu urew il- presenza ta ’ livelli baxxi ta ’ ibandronic acid fil- ħalib wara amministrazzjoni ġol - vina.
Bondronat should not be used during lactation.
Bondronat ma għandux jintuża waqt it- treddigħ.
No studies on the effects on the ability to drive and use machines have been performed.
Ma saru l- ebda studji fuq il- ħila biex issuq u tħaddim ta ’ magni.
Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), and very rare (≤ 0.01%).
Reazzjonijiet avversi huma kklassifikati taħt it- titlu tal- frekwenza, l- aktar frekwenti l- ewwel, bil - konvenzjoni li ġejja: komuni ħafna (≥ 10%), komuni (≥ 1% u < 10%), mhux komuni (≥ 0. 1% u < 1%), rari (≥ 0. 01% u < 0. 1%), rari ħafna (≤ 0. 01%).
Treatment of Tumour Induced Hypercalcaemia The safety profile for Bondronat in tumour-induced hypercalcaemia is derived from controlled clinical trials in this indication and after the intravenous administration of Bondronat at the recommended doses.
Trattament ta ’ Iperkalċemja Kkawżata minn Tumur Il- profil tas- sigurtà għal Bondronat f’ iperkalċemja kkawżata minn tumur huwa derivat minn provi kliniċi kkontrollati f’ din l- indikazzjoni u wara l- amministrazzjoni ġol- vina ta ’ Bondronat fid- dożi rrakkomandati.
Treatment was most commonly associated with a rise in body temperature.
It- trattament kien assoċjat l- iktar ma ’ żjieda fit- temperatura tal- ġisem.
Occasionally, a flu- like syndrome consisting of fever, chills, bone and/ or muscle ache-like pain was reported.
Xi kultant, sindromi li jixbħu l- influwenza li jikkonsistu f’ deni, tkexkix, uġigħ fl- għadam jew/ u fil- muskoli ġew irrapportati.
In most cases no specific treatment was required and the symptoms subsided after a couple of hours/ days.
Fil- maġġoranza tal- każijiet ma kien jinħtieġ l- ebda trattament speċifiku u s- sintomi battew wara xi ftit sigħat/ ġranet.
Table 1 lists adverse reactions recorded in the trials (events were recorded irrespective of a determination of causality).
Tabella 1 telenka r- reazzjonijiet avversi rekordjati fil- provi (eventi ġew irrekordjati irrispettivament mid- determinazzjoni tal- kawżalità).
Number (percentage) of Patients Reporting Adverse Reactions in Controlled Clinical Trials in Tumour-Induced Hypercalcaemia after Treatment with Bondronat
Numru (perċentwal) ta ’ Pazjenti li Rrapportaw Reazzjonijiet Avversi fil- Provi Kliniċi Kontrollati f’ Iperkalċemja Kkawżata minn Tumur wara Trattament b’ Bondronat
System Organ
Sistema tal- klassifika tal- organi / Reazzjoni Avversa
Class / Adverse reaction Frequency Number (%) (n=352)
Frekwenza Numru (%) (n=352)
Metabolism and nutrition disorders Common:
Mard marbut mal- metaboliżmu u n- nutrizzjoni:
10 (2.8)
Komuni:
5 System Organ Class / Adverse reaction Musculoskeletal and connective tissue disorders:
Mard muskolu- skeltrali u tal- connective tissue:
Frequency Number (%) (n=352)
ipokalċemja
Bone Pain Uncommon:
Uġigħ fl- Għadam Mhux Komuni:
Myalgia
Mijalgja
6 (1.7) 1 (0.3)
6 (1. 7) 1 (0. 3)
General disorders and administration site conditions:
Mard ġenerali u kondizzjonijiet ta 'mnejn jingħata:
Pyrexia Uncommon:
Deni Mhux komuni:
Influenza-like illness Rigors
Mard bħall- influwenza Tertir
39 (11.1) 2 (0.6) 1 (0.3)
39 (11. 1) 2 (0. 6) 1 (0. 3)
Data for both the 2 mg and 4 mg doses of ibandronic acid are pooled.
Data għad- doża ta ’ 2 mg kif ukoll ta ’ 4 mg ta ’ ibandronic acid huma miġbura flimkien.
Events were recorded irrespective of a determination of causality.
Avvenimenti ġew irrekordjati irrispetivament mid- determinazzjoni tal- kawżalità.
Frequently, decreased renal calcium excretion is accompanied by a fall in serum phosphate levels not requiring therapeutic measures.
Ta ’ spiss, tnaqqis ta ’ l- eliminazzjoni tal- kalċju mill- kliewi huwa akkompanjat bi tnaqqis fil- livelli tal - fosfat fis- serum li ma jirrekjedix miżuri terapewtiċi.
The serum calcium level may fall to hypocalcaemic values.
Il- livell tal- kalċju tas- serum jista ’ jaqa ’ għal valuri ta ’ ipokalċemja.
Other reactions reported at lower frequency are as follows:
Reazzjonijiet oħrajn li jseħħu fi frekwenza iktar baxxa huma dawk li ġejjin:
Immune system disorders:
Mard tas- sistema immuni:
Hypersensitivity
Ipersensittività
Skin and subcutaneous tissue disorders:
Mard tal- ġilda Rari ħafna:
Angioneurotic oedema
Edema anġjonewrotika
Respiratory, thoracic and mediastinal disorders:
Mard respiratorju, toraċiku u medjastinali:
of other bisphosphonates has been associated with broncho-constriction in
BronkospażmuL- amministrazzjoni ta ’ bisfosfonati oħrajn kienet assoċjata ma ’
acetylsalicylic acid-sensitive asthmatic patients.
bronko- kostrizzjoni f’ pazjenti li jbatu bl- ażma b’ sensittività għal acetylsalicylic acid.
Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases The safety profile of intravenous Bondronat in patients with breast cancer and bone metastases is derived from a controlled clinical trial in this indication and after the intravenous administration of Bondronat at the recommended dose.
Prevenzjoni ta ’ Episodji skeletriċi f’ Pazjenti b’ kanċer tas- Sider u Metastażi fl- għadam Il- profil tas- sigurtà ta ’ pazjenti li ngħataw Bondronat ġol- vina b’ kanċer tas- sider u metastażi fl - għadam huwa derivat minn prova klinika kkontrollata b’ din l- indikazzjoni u wara l- amministrazzjoni ġol- vina ta ’ Bondronat fid- doża rrakkomandata.
Table 2 lists adverse reactions from the pivotal phase III study (152 patients treated with Bondronat 6 mg), i. e. adverse events with a remote, possible, or probable relationship to study medication, occurring commonly and more frequently in the active treatment group than in placebo.
Tabella 2 telenka reazzjonijiet avversi mill- fażi pivotali III (152 pazjent trattati b’ Bondronat 6 mg), jiġifieri effetti avversi b’ relazzjoni remota, possibbli, jew probabbli mal- medikazzjoni taħt studju, li jseħħ ta ’ spiss u iktar frekwentement fil- grupp attiv tat- trattament milli fil- plaċebo.
Adverse Reactions Occurring Commonly and Greater than Placebo in Patients with Metastatic Bone Disease due to Breast Cancer Treated with Bondronat 6 mg administered intravenously
Reazzjonijiet Avversi li Jseħħu ta ’ Spiss u iktar mill- Plaċebo f’ Pazjenti b’ Metastażi fl- għadam minnħabba kanċer tas- Sider Trattat bil- Bondronat 6 mg mogħtija ġol - vina
Adverse Reaction
Reazzjoni Avvers
Placebo (n = 157) No.
(%) No.
(%)
Infezzjonijiet u
Infections and Infestations:
Infestazzjonijiet:
Infection
Infezzjoni
1 (0.6)
1 (0. 6)
2 (1.3)
2 (1. 3)
Endocrine disorders:
Mard tal- paratirojd
Nervous
2 (1. 3)
Parathyroid disorder System disorders:
Mard tas- Sistema Nervuża:
1 (0.6)
6 Reazzjoni Avvers
2 (1.3)
Plaċebo
4 (2.5) 2 (1.3) 0 (0.0)
Bondronat 6 mg
9 (5.9) 4 (2.6) 2 (1.3)
(%)
6 Adverse Reaction
(%)
Placebo
Uġigħ ta ’ Ras Sturdament Disgewsja (bidla fit- togħma)
Bondronat 6mg
4 (2. 5) 2 (1. 3) 0 (0. 0)
Eye disorders:
9 (5. 9) 4 (2. 6) 2 (1. 3)
(%)
Mard ta’ l- Għajnejn:
(n = 152) No.
Kataretti
Cataract Cardiac disorders:
1 (0. 6)
1 (0.6)
2 (1. 3)
2 (1.3)
Mard tal- qalb:
Bundle branch block Respiratory, thoracic and mediastinal disorders:
Bundle branch block
Pharyngitis Gastrointestinal disorders:
Mard respiratorju, toraċiku u medjastinali:
0 (0.0)
Faringite
3 (2.0)
0 (0. 0)
1 (0.6) 5 (3.2) 2 (1.3) 2 (1.3) 0 (0.0)
3 (2. 0)
8 (5.3) 6 (3.9) 5 (3.3) 4 (2.6) 3 (2.0)
Mard gastro- intestinali:
Skin disorder Ecchymosis Musculoskeletal and connective tissue disorders:
Mard tal- ġilda u tat- tessuti ta ’ taħt il - ġilda:
0 (0.0) 0 (0.0)
0 (0. 0) 0 (0. 0)
2 (1.3) 2 (1.3)
2 (1. 3) 2 (1. 3)
Myalgia Arthralgia Joint disorder Osteoarthritis General disorders:
Mard muskolu- skeltrali u tal- connective tissue:
6 (3.8) 1 (0.6) 0 (0.0) 0 (0.0)
6 (3. 8) 1 (0. 6) 0 (0. 0) 0 (0. 0)
8 (5.3) 2 (1.3) 2 (1.3) 2 (1.3)
8 (5. 3) 2 (1. 3) 2 (1. 3) 2 (1. 3)
Asthenia Influenza-like illness Oedema peripheral Thirst Investigations:
Astenja Mard li jixbah lill- influwenza Edema periferali Għatx
8 (5.1) 2 (1.3) 2 (1.3) 0 (0.0)
8 (5. 1) 2 (1. 3) 2 (1. 3) 0 (0. 0)
10 (6.6) 8 (5.3) 3 (2.0) 2 (1.3)
Investigazzjonijiet:
Gamma-GT increased Creatinine increased
Żieda tal- gamma- GT Żieda tal- kreatinina
1 (0.6) 1 (0.6)
1 (0. 6) 1 (0. 6)
4 (2.6) 3 (2.0)
4 (2. 6) 3 (2. 0)
Other adverse reactions reported at a lower frequency are as follows:
Reazzjonijiet avversi oħrajn rrapportati f’ frekwenza iżjed baxxa huma s- segwenti:
Infection and infestation: cystitis, vaginitis, oral candidiasis Neoplasms benign and malignant (including cysts and polyps): benign skin neoplasm Blood and lymphatic system: anaemia, blood dyscrasia Metabolism and nutrition disorders: hypophosphataemia Psychiatric disorders: sleep disorder, anxiety, affection lability Nervous system disorders: cerbrovascular disorder, nerve root lesion, amnesia, migraine, neuralgia, hypertonia, hyperaestesia, paraesthesia circumoral, parosmia.
Infezzjonijiet u infestazzjonijiet: ċistite, vaġinite, kandidjażi orali Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi): neoplażmi tal- ġilda beninji Mard tad- demm u tas- sistema limfatika: anemja, diskrajażi tad- demm Mard marbut mal- metabolismu u nutrizzjoni: ipofosfatemja Mard psikjatriku: mard ta ’ l- irqad, ansjetà, lijabilità affettiva Mard tas- sistema nervuża: mard ċerebrovaskulari, ferita ta ’ l- għerq tan- nerv, amneżja, migranja, newralġija, ipertonja, iperesteżija, parasteżija ċirkumorali, parosmja.
Ear and labyrinth disorders: deafness Cardiac disorders: myocardial ischaemia, cardiovascular disorder, palpitations Vascular disorders: hypertension, lymphoedema, varicose veins Respiratory, thoracic and mediastinal disorders: lung oedema, stridor Gastrointestinal disorders: gastroenteritis, dysphagia, gastritis, mouth ulceration, cheilitis Hepato-biliary disorders: cholelithiasis Skin and subcutaneous tissue disorders: rash, alopecia Renal and urinary disorders: urinary retention, renal cyst Reproductive system and breast disorders: pelvic pain General disorders and administration site conditions: hypothermia Investigations: blood alkaline phosphatase increase, weight decrease Injury, poisoning and procedural complications: injury, injection site pain
Mard tal- widnejn u tas- sistema labirintika: truxija Mard tal- qalb: iskimja mijokardjali, mard kardjovaskolari, palpitazzjonijiet Mard vaskulari: ipertensjoni, limfoedema, vini varikużi Mard respiratorju, toraċiku u medjastinali: edema tal- pulmum, stridor Mard gastro- intestinali: gastroenterite, disfaġja, gastrite, ulċerazzjoni tal- ħalq, kelite Mard tal- fwied u tal- marrara: kolelitijażi Mard tal- ġilda u tessuti taħta: raxx, alopeċja
7 Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
7 Mard tal- kliewi u tas- sistema urinarja: retenzjoni ta ’ l- urina, ċista tal- kliewi Mard tas- sistema riproduttiva u tas- sider: uġigħ pelviku Mard ġenerali u kundizzjonijiet ta 'mnejn jingħata: ipotermja Investigazzjonijiet: żjieda ta ’ alkaline phosphatase fid- demm, tnaqqis fil- piż Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura: korriment, uġigħ fil- lok ta ’ l - injezzjoni
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 għal- pazjenti tal- kanċer, iżda każijiet simili ġew rapportati f’ pazjenti li rċevew kura għall- osteoporożi.
Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
Osteonekrożi tax- xedaq huwa ġeneralment assoċċjat ma ’ l- estrazzjoni tas- snien u/ jew infezzjoni lokali (inkluż osteomielite).
Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
Dijanjosi tal- kanċer, kemjoterapija, radjuterapija, kortikosterojdi u iġene orali batuta ukoll huma meqjusa bħala fatturi ta ’ riskju (ara sezzjoni 4. 4).
Up to now there is no experience of acute poisoning with Bondronat concentrate for solution for infusion.
Sa issa ma hemm l- ebda każ ta ’ doża eċċessiva bil- konċentrat ta ’ Bondronat għal soluzzjoni għall - infużjoni.
Since both the kidney and the liver were found to be target organs for toxicity in preclinical studies with high doses, kidney and liver function should be monitored.
Minħabba li fi studji pre- kliniċi b’ dożi għolja, kemm il- kliewi kif ukoll il- fwied instabu li kienu organi li setgħu kienu milquta minn tossiċita, il- funzjoni tal- kliewi u tal- fwied għandhom jiġu mmonitorjati.
Clinically relevant hypocalcaemia should be corrected by intravenous administration of calcium gluconate.
Ipokalċemja li tkun klinikament relevanti għandha tkun ikkurata permezz ta ’ amministrazzjoni ġol- vina ta ’ calcium gluconate.
Pharmaco-therapeutic group:
Kategorija farmakoterapewtika:
Bisphosphonate, ATC Code:
Bisfosfonat, Kodiċi ATC:
Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone.
Ibandronic acid jappartjeni għas- sustanzi tal- grupp ta ’ bisfosfonati li jaħdmu speċifikament fuq l - għadam.
Their selective action on bone tissue is based on the high affinity of bisphosphonates for bone mineral.
L- azzjoni selettiva tagħhom fuq it- tessut ta ’ l- għadam hija bbażata fuq l- affinità għolja tal - bisfosfonati għall- minerali fl- għadam.
Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear.
Il- bisfosfonati jaħdmu bl- inibizzjoni ta ’ l- attività ta ’ l - osteoclasts, għalkemm il- mekkaniżmu preċiż għadu mhuwiex ċar.
In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.
In vivo, ibandronic acid jimpedixxi l- qerda ta ’ l- għadam stimolat b’ mod sperimentali u kkawżat bil - waqfien tal- funzjoni tal- gonadi, retinojdi, tumuri jew estratti tat- tumuri.
The inhibition of endogenous bone resorption has also been documented by 45Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton.
L- inibizzjoni ta ’ assorbiment endoġenu ta ’ l- għadam ġie dokumentat ukoll permezz ta ’ studji kinetiċi ta ’ 45Ca u l- liberazzjoni ta ’ tetraċiklina radjuattiva li kienet qabel inkorporata fl- iskeletru.
At doses that were considerably higher than the pharmacologically effective doses, ibandronic acid did not have any effect on bone mineralisation.
F’ dożi li kienu ogħla mhux ħażin minn dożi effettivi farmakoloġiċi, ibandronic acid ma kellu l- ebda effett fuq il- mineralizzazzjoni ta ’ l- għadam.
Bone resorption due to malignant disease is characterized by excessive bone resorption that is not balanced with appropriate bone formation.
Assorbiment ta ’ l- għadam ikkawżat minn mard malinn huwa kkaratterizzat b’ assorbiment eċċessiv ta ’ l- għadam li mhuwiex ibbilanċjat minn formazzjoni ta ’ l- għadam adegwat.
Ibandronic acid selectively inhibits osteoclast activity, reducing bone resorption and thereby reducing skeletal complications of the malignant disease.
Ibandronic acid jinibixxi selettivament l- attività tal- osteoclasts, u b’ hekk inaqqas l- assorbiment mill- ġdid ta ’ l- għadam u b’ hekk inaqqas il- komplikazzjonijiet skeletriċi tal- marda malinna.
Clinical Studies in the Treatment of Tumour-Induced Hypercalcemia Clinical studies in hypercalcaemia of malignancy demonstrated that the inhibitory effect of ibandronic acid on tumour-induced osteolysis, and specifically on tumour-induced hypercalcaemia, is characterised by a decrease in serum calcium and urinary calcium excretion.
Studji Kliniċi fit- Trattament ta ’ l- Iperkalċemja Kkawżata minn Tumur Studji kliniċi fl- iperkalċemja malinna wriet li l- effett inibitorju ta ’ Ibandronic acid fuq osteolisi kkawżata mit- tumur, u speċifikament fuq l- iperkalċemja kkawżata minn tumur, hija kkaratterizzata bi tnaqqis fil- kalċju fis- serum u eliminazzjoni tal- kalċju fl- urina.
In the dose range recommended for treatment, the following response rates with the respective confidence intervals have been shown in clinical trials for patients with baseline albumin-corrected serum calcium ≥ 3.0 mmol/ l after adequate rehydration.
Fl- iskala tad- doża rrakkomandata għat- trattament, ir- rati ta ’ rispons li ġejjin, bl- intervalli tal - konfidenza rispettivi, ntwerew fi provi kliniċi għall- pazjenti b’ linja bażika ta’ kalċju fis- serum ikkoreġut bl- albumina ≥ 3. 0 mmol/ l wara rijidrattazzjoni adegwata.
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For these patients and dosages, the median time to achieve normocalcaemia was 4 to 7 days.
Għal dawn il- pazjenti u dożaġġi, iż- żmien medjan sa biex tintlaħaq in- normokalċemija kien ta ’ bejn 4 u 7 ijiem.
The median time to relapse (return of albumin-corrected serum calcium above 3.0 mmol/ l) was 18 to 26 days.
Iż- żmien medjan sa biex il- livell jerġa jgħola (ir- ritorn għal- livelli ta ’ 'l fuq minn 3 mmol/ l ta ’ kalċju fis- serum ikkoreġut bl- albumina) kien ta ’ 18 – 26 ġurnata.
Clinical Studies in the Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases Clinical studies in patients with breast cancer and bone metastases have shown that there is a dose dependent inhibitory effect on bone osteolysis, expressed by markers of bone resorption, and a dose dependent effect on skeletal events.
Studji kliniċi f’ pazjenti b’ kanċer tas- sider u metastasi fl- għadam urew li hemm effett inibitorju dipendenti mid- doża fuq l- osteoliżi ta ’ l- għadam, espress b’ markaturi ta ’ assorbiment ta ’ l- għadam, u effett dipendenti mid- doża fuq reazzjonijiet skeletriċi.
Prevention of skeletal events in patients with breast cancer and bone metastases with Bondronat 6 mg administered intravenously was assessed in one randomized placebo controlled phase III trial with duration of 96 weeks.
plaċebo ta ’ fażi III b’ dewmien ta ’ 96 ġimgħa.
Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (158 patients) or 6 mg Bondronat (154 patients).
Pazjenti femminili b’ kanċer tas- sider u metastażi fl - għadam ikkonfermat radjologikament tħalltu sa biex jirċievu l- plaċebo (158 pazjent) jew 6 mg Bondronat (154 pazjent).
The results from this trial are summarised below.
Ir- riżultati ta ’ din il- prova huma miġbura fil- qosor hawn taħt.
Primary Efficacy Endpoints The primary endpoint of the trial was the skeletal morbidity period rate (SMPR).
Il -- mira primarja ta ’ l- istudji kienet ir- rata tal- perjodu tal- morbidità skeletrika (SMPR).
This was a composite endpoint which had the following skeletal related events (SREs) as sub-components:
Din kienet mira komposta li kellha l- episodji relatati ma ’ l- iskeletru (SREs) li ġejjin bħala l- komponenti tagħha:
- radiotherapy to bone for treatment of fractures/ impending fractures
- - - -
- surgery to bone for treatment of fractures
radjuterapija fl- għadam għat- trattament ta ’ fratturi/ fratturi imminenti kirurġija fl- għadam għat- trattament ta ’ fratturi fratturi vertebrali fratturi mhux vertebrali
- vertebral fractures
L- analisi ta ’ 12- il
- non-vertebral fractures.
Effetti multipli kienu għalhekk, magħduda biss darba
Multiple events were therefore counted only once for the purposes of the analysis.
fi kwalunkwe perijodu ta ’ 12- il ġimgħa għall- iskopijiet ta ’ din l- analiżi.
Data from this study demonstrated a significant advantage for intravenous Bondronat 6 mg over placebo in the reduction in SREs measured by the time-adjusted SMPR (p=0.004).
Tagħrif minn dan l- istudju wriet vantaġġ sinifikanti għal Bondronat 6 mg ġol- vina fuq il- plaċebo biex inaqqas SREs mkejla b’ SMPR aġġustat mal- ħin (p=0. 004).
The number of SREs was also significantly reduced with Bondronat 6 mg and there was a 40% reduction in the risk of a SRE over placebo (relative risk 0.6, p = 0.003).
In- numru ta ’ SREs kien imnaqqas b’ mod sinifikanti b’ Bondronat 6 mg u kien hemm tnaqqis ta ’ 40% fir- riskju ta ’ SRE fuq il- plaċebo (riskju relattiv 0. 6, p =0. 003).
Efficacy results are summarised in Table 3.
Tabella 3
9 Table 3
Riżultati ta ’ l- Effikaċja (Pazjenti b’ Kanċer tas- Sider b’ Mard Metastatiku fl - Għadam)
Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Episodji Kollha Relatati ma ’ l- Iskeletru (SREs)
All Skeletal Related Events (SREs) Placebo Bondronat 6 mg p-value n=158 n=154
Plaċebo n=158
SMPR (per patient year)
SMPR (għal kull sena ta ’ pazjent)
1.19
1. 19
p=0.004
P=0. 004
Number of events (per patient)
Numru ta ’ effetti (għal kull pazjent)
3.64
3. 64
p=0.025
P=0. 025
SRE relative risk
Riskju relattiv ta ’ SRE
p=0.003
P=0. 003
Secondary Efficacy Endpoints A statistically significant improvement in bone pain score was shown for intravenous Bondronat 6 mg compared to placebo.
L- Miri Sekondarji ta ’ l- Effikaċja Titjib għall- aħjar fil- marka ta ’ l- uġigħ fl- għadam statistikament sinifikanti intwera għal Bondronat 6 mg ġol- vina meta mqabbel mal- plaċebo.
The pain reduction was consistently below baseline throughout the entire study and accompanied by a significantly reduced use of analgesics.
It- tnaqqis fl- uġigħ kien b’ mod konformi taħt il - linja bażika matul l- istudju kollu u kien akkumpanjat b’ użu mnaqqas sinifikattiv ta ’ analġesiċi meta
The deterioration in Quality of Life was significantly less in Bondronat treated patients compared with placebo.
Id- deterjorament tal- Kwalità tal- Ħajja kienet sinifikatament inqas fil- pazjenti kkurati b’ Bondronat meta mqabbla mal- plaċebo.
A tabular summary of these secondary efficacy results is presented in Table 4.
Taqsira tabellari ta ’ dawn ir- riżultati ta ’ l- effikaċja sekondarja hija ppreżentata f' Tabella 4.
cancer Patients with Metastatic Bone Disease)
Riżultati ta ’ l- Effikaċja Sekondarja (Pazjenti b’ Kanċer tas- Sider b’ Mard - Metastatiku ta ’ l- Għadam)
Placebo n=158
Plaċebo Bondronat 6 mg Valur- p n=158 n=154
Bondronat 6 mg p-value n=154
Uġigħ fl- għadam *
Bone pain *
0. 21
0.21
- 0. 28
-0.28 p < 0.001
p < 0. 001
Analgesic use *
Użu analġesiku *
0.51
0. 51
p=0.083
p=0. 083
Quality of Life *
Kwalità tal- Ħajja *
-45.4
- 45. 4
-10.3
- 10. 3
p=0.004
p=0. 004
* Mean change from baseline to last assessment.
* Bidla medja mill- linja bażika sa l- aħħar eżami.
There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with Bondronat that was statistically significant compared to placebo.
Kien hemm tnaqqis sinifikanti ta ’ markaturi fl- urina ta ’ assorbiment mill- ġdid ta ’ l- għadam (pyridinoline u deoxypyridinoline) f’ pazjenti ttrattati b’ Bondronat li kien statistikament sinifikanti meta mqabbel mal- plaċebo.
In a study in 130 patients with metastatic breast cancer the safety of Bondronat infused over 1 hour or 15 minutes was compared.
Fi studju f’ 130 pazjent b’ kanċer metastatiku tas- sider, kienet imqabbla is- sigurtà ta ’ Bondronat mgħoti bħala infużjoni fuq medda ta ’ siegħa, jew 15- il minuta.
No difference was observed in the indicators of renal function.
L- ebda differenza ma kienet osservata fl - indikaturi tal- funzjoni renali.
The overall adverse event profile of ibandronic acid following the 15 minute infusion was consistent with the known safety profile over longer infusion times and no new safety concerns were identified relating to the use of a 15 minute infusion time.
Il- profil totali ta ’ reazzjonijiet avversi ta ’ ibandronic acid wara l - infużjoni ta ’ 15- il minuta kien konsistenti mal- profil magħruf ta ’ sigurtà għall- infużjonijiet fuq medda ta ’ ħin itwal, u l- ebda tħassib ta ’ sigurtà ġdid relatat ma ’ l- użu ta ’ ħin ta ’ l- infużjoni ta ’ 15- il minuta ma kien identifikat.
A 15 minute infusion time has not been studied in cancer patients with a creatinine clearance of < 50ml/ min.
Ħin ta ’ l- infużjoni ta ’ 15- il minuta ma ġiex studjat f’ pazjenti tal- kanċer bi tneħħija ta ’ kreatinina ta ’ < 50 ml/ min.
After a 2 hour infusion of 2, 4 and 6 mg ibandronic acid pharmacokinetic parameters are dose proportional.
Wara infużjoni ta ’ sagħtejn (2) ta ’ 2, 4 u 6 mg ta ’ ibandronic acid il- parametri farmakokinetiċi huma fi proporzjon mad- doża.
Distribution After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine.
Distribuzzjoni Wara espożizzjoni sistemika fil- bidu tat- terapija, ibandronic acid jingħaqad malajr ma ’ l- għadam jew jiġi eliminat fl- urina.
Protein binding in human plasma is
Fil- bnedmin, il- volum apparenti tad- distribuzzjoni terminali huwa mill- inqas 90 l u l- ammont tad- doża li jilħaq l- għadam huwa stmat li huwa 40- 50% tad- doża fiċ- ċirkolazzjoni.
10 approximately 87% at therapeutic concentrations, and thus drug-drug interaction due to displacement is unlikely.
L - għaqda mal- proteini fil- plażma umana hija bejn wieħed u ieħor 87% f’ konċentrazzjonijiet terapewtiċi, u għalhekk interazzjoni bejn mediċini minħabba spostament mhuwiex probabbli.
Metabolism There is no evidence that ibandronic acid is metabolized in animals or humans.
Metaboliżmu M’ hemm l- ebda evidenza li ibandronic acid jiġi metabolizzat fl- annimali jew fil- bnedmin.
Elimination The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Eliminazzjoni Il- firxa osservata ta ’ half- lifes apparenti hija wiesgħa u tiddependi fuq id- doża u s- sensittività ta ’ l - analażi, iżda jidher li l- half- life terminali apparenti huwa fl- iskala ta ’ bejn 10- 60 siegħa.
However, early plasma levels fall quickly, reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Iżda, livelli tal- plażma tal- bidu jaqgħu malajr, li jilħqu l- 10% ta ’ l- għola valuri f’ medda ta ’ bejn 3 u 8 sigħat wara amministrazzjoni ġol- vina jew orali rispettivament.
No systemic accumulation was observed when ibandronic acid was administered intravenously once every 4 weeks for 48 weeks to patients with metastatic bone disease.
L- ebda akkumulazzjoni sistematika ma ġiet osservata meta ibandronic acid ġie amministrat ġol- vina darba kull 4 ġimgħat għal 48 ġimgħa lill - pazjenti b’ mard metastatiku ta ’ l- għadam.
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’ livelli medji b’ firxa 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 f’ saħħithom li għaddew mill- menopawża) tagħmel għal 50 -
The difference between the apparent total and renal clearances is considered to reflect the uptake by bone.
10 60% mit- tneħħija totali u hija relatata mat- tneħħija tal- kreatinina.
Pharmacokinetics in Special Populations
Farmakokinetika f’ Popolazzjonijiet Speċjali
Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in both men and women.
Sess Il- farmakokinetika ta ’ ibandronic acid u l- biodisponibiltà huma simili f’ kemm l- irġiel u fin- nisa.
Race There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Razza M’ hemmx evidenza għal differenzi interetniċi ta ’ rilevanza klinika bejn l- Ażjatiċi u l- Kawkasi fid - disposizzjoni ta ’ ibandronic acid.
There are only very few data available on patients with African origin.
Hemm tagħrif limitata ħafna fuq pazjenti ta ’ oriġini Afrikana.
Patients with renal impairment Exposure to ibandronic acid in patients with various degrees of renal impairment is related to creatinine clearance (CLcr).
Pazjenti b’ indeboliment tal- kliewi Espożizzjoni għal ibandronic acid f’ pazjenti b’ livelli varji ta ’ indeboliment tal- kliewi hija relatata mat - tneħħija tal- kreatinina (CLcr).
In clinical pharmacology trial WP18551, after a single dose intravenous administration of 6 mg (15 minutes infusion), mean AUC0-24 increased by 14% and 86%, respectively, in subjects with mild (mean estimated CLcr=68.1 mL/ min) and moderate (mean estimated CLcr=41.2 mL/ min) renal impairment compared to healthy volunteers (mean estimated CLcr=120 mL/ min).
Fl- istudju kliniku tal- farmakoloġija WP18551, wara l- għotja ta ’ doża waħda ta ’ 6 mg (fuq medda ta ’ 15- il minuta) ġol- vina, l’ AUC0- 24 medja żdiedet b’ 14% u 86% rispettivament, f’ soġġetti b’ indeboliment renali ħafif (CLcr medja stmata =68. 1 mL/ min) u moderat (CLcr medja stmata =41. 2 mL/ min), meta mqabbla ma ’ voluntiera b’ saħħithom (CLcr medja stmata=120 mL/ min).
Mean Cmax was not increased in patients with mild renal impairment and increased by 12% in patients with moderate renal impairment.
Cmax medja ma żdieditx f’ pazjenti b’ indeboliment renali ħafif, u żdiedet bi 12% f’ pazjenti b’ indeboliment renali moderat.
There is no evidence of a reduction in tolerability associated with an increase in exposure.
Ma hemm l- ebda evidenza ta ’ tnaqqis fit- tollerabilità assoċjata ma ’ żjieda fl- espożizzjoni.
However, an adjustment in the dose or infusion time is recommended in patients being treated for the prevention of skeletal events in patients with breast cancer and bone metastases (see section 4.2).
Madankollu, aġġustament fid- doża jew fil- ħin ta ’ l- infużjoni hija rakkomandata f’ pazjenti li qed jiġu kkurati għall- prevenzjoni ta ’ episodji skeletriċi f’ pazjenti b’ kanċer tas- sider u metastazi fl- għadam (ara sezzjoni 4. 2).
Patients with hepatic impairment There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Pazjenti b’ indeboliment tal- fwied M’ hemm l- ebda tagħrif farmakokinetiku għal ibandronic acid f’ pazjenti li għandhom indeboliment tal - fwied.
The liver has no significant role in the clearance of ibandronic acid since it is not metabolized but is cleared by renal excretion and by uptake into bone.
Il- fwied m’ għandu l- ebda rwol sinifikanti fit- tneħħija ta ’ ibandronic acid għax ma jiġix metabolizzat imma jitneħħa permezz tal- kliewi u b’ assorbiment fl- għadam.
Therefore dosage adjustment is not necessary in patients with hepatic impairment.
Għalhekk aġġustament fid- doża mhuwiex neċessarju f’ pazjenti b’ indeboliment tal- fwied.
Further, as protein binding of ibandronic acid is approximately 87% at therapeutic concentrations, hypoproteinaemia in severe liver disease is unlikely to lead to clinically significant increases in free plasma concentration.
Mhux hekk biss imma, peress li l - għaqda ta ’ ibandronic acid mal- proteini hija madwar 87% f’ konċentrazzjonijiet terapewtiċi, ipoprotenemja f’ mard serju fil- fwied x’ aktarx ma jwassalx għal żidiet ta ’ sinifikat kliniku fil - konċentrazzjoni ħielsa fil- plażma.
Elderly In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
L- anzjani F’ analiżi multivarjata, instab li l- età mhix fattur indipendenti ta ’ kwalunkwe parametru farmakokinetiku li ġie studjat.
As renal function decreases with age, this is the only factor that should be considered (see renal impairment section).
Hekk kif il- funzjoni renali tonqos bl- eta ’, dan huwa l- uniku fattur li għandu jiġi kkunsidrat (ara sezzjoni indeboliment tal- kliewi).
Children and adolescents There are no data on the use of Bondronat in patients less than 18 years old.
Tfal u adoloxxenti M’ hemm l- ebda tagħrif fuq l- użu ta ’ Bondronat f’ pazjenti ta ’ eta ’ inqas minn 18- il sena.
5.3 Preclinical safety data
5. 3 Tagħrif ta ‘ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
11 Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Fi studji mhux kliniċi ġew osservati effetti biss f’ esposizzjonijiet ħafna aktar eċċessivi mill - esposizzjoni massima umana li tindika ftit rilevanza għall- użu kliniku.
As with other bisphosphonates, the kidney was identified to be the primary target organ of systemic toxicity.
Bħall- bisfosfonati l- oħra, il - kilwa ġiet identifikata bħala l- organu primarju ta ’ tossiċità sistemika.
No indication of carcinogenic potential was observed.
Mutaġeniċità/ Karċinoġeniċità L- ebda indikazzjoni ta ’ potenzjal karċinoġeniku ma ġie osservat.
Tests for genotoxicity revealed no evidence of effects on genetic activity for ibandronic acid.
Testijiet għal ġenotossiċità ma urew l- ebda evidenza ta ’ attività ġenetika għal ibandronic acid.
Reproductive toxicity:
Tossiċità riproduttiva:
No evidence of direct foetal toxicity or teratogenic effects were observed for ibandronic acid in intravenously treated rats and rabbits.
L- ebda evidenza ta ’ tossiċità diretta fuq il- fetu jew effetti teratoġeniċi ma ġew osservati għal ibandronic acid fil- firien u fil- fniek trattati ġol- vina.
Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those expected for this class of drug (bisphosphonates).
Effetti mhux mixtieqa ta ’ ibandronic acid fi studji ta ’ tossiċità riproduttiva fil- far kienu dawk mistennija għal din il- klassi ta ’ mediċini (bisfosfonati).
They include a decreased number of implantation sites, interference with natural delivery (dystocia), an increase in visceral variations (renal pelvis ureter syndrome) and teeth abnormalities in F1 offspring in rats.
Dawn jinkludu numru iżgħar ta ’ siti ta ’ implantazzjoni, interferenza fil- ħlas naturali (distoċja), żieda fil- varjazzjonijiet vixxerali (sindromu ta ’ l- uretru pelviku renali) u anomaliji fis- snien fil- ġenerazzjoni F1 fil- firien.
Sodium chloride Acetic acid (99%) Sodium acetate Water for injections
Sodium chloride Acetic acid (99%) Sodium acetate Ilma għall- injezzjoni
To avoid potential incompatibilities Bondronat concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Biex jiġu evitati inkompatabiltajiet potenzjali Bondronat konċentrat għal soluzzjoni għall- infużjoni għandu jiġi dilwit biss ma ’ soluzzjoni ta ’ sodium chloride jew soluzzjoni ta ’ dextrose 5%.
Bondronat should not be mixed with calcium containing solutions.
Bondronat m’ għandux jitħallat ma ’ soluzzjonijiet li fihom il- kalċju.
5 years After reconstitution:
5 snin Wara r- rikostituzzjoni:
24 hours.
24 siegħa.
6.4 Special precautions for storage
Tagħrif speċjali dwar kif għandu jinħażen 6. 4
No special precautions for storage prior to reconstitution.
M' hemmx prekawzjonijiet speċjali għall- ħażna qabel ir- rikostituzzjoni.
After reconstitution:
Wara r- rikostituzzjoni:
Store at 2 °C – 8 °C (in a refrigerator).
Aħżen f’ temperatura ta ’ bejn 2 °C – 8 °C (fil- friġġ).
From a microbiological point of view, the product should be used immediately.
Minn aspett mikrobijoloġiku, il- prodott għandu jintuża immedjatament.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, il- perjodu u l- kundizzjonijiet tal- ħażna qabel l- użu huma r- responsabilità ta ’ min jużah u normalment ma jkunx ta ’ iktar minn 24 siegħa f’ temperatura ta ’ bejn 2 °C – 8 °C, sa kemm r - rikostituzzjoni ma sseħħx f’ kundizzjonijiet kontrollati u validati asettiċitament.
Bondronat is supplied as packs containing 1 vial (2 ml type I glass vial).
Bondronat jiġi f’ pakketti li fihom kunjett 1 (kunjett tal- ħġieġ ta ’ 2 ml tat- tip I).
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TA ’ L- AWTORIZZAZZJONI
Date of first Authorisation:
Data ta ’ l- ewwel Awtorizzazzjoni:
25 June 1996
25 ta’ Ġunju 1996
Date of last renewal:
Data ta ’ l- aħħar tiġdid:
25 June 2006
25 ta ’ Ġunju 2006
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
Bondronat 50 mg Film Coated Tablets
Bondronat 50 mg Pilloli miksija b’ rita
Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronic sodium monohydrate).
Kull pillola miksija b’ rita għandha 50 mg ta ’ ibandronic acid (bħala ibandronic sodium monohydrate).
Bondronat tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Il- pilloli Bondronat fihom lattosju u ma għandhomx jingħataw lill- pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għal galattosjua, defiċenza Lapp lactase jew malassorbiment tal - glukosju- galattosju.
Film-coated tablets.
Pilloli miksija b’ rita.
White to off-white film-coated tablets, of oblong shape engraved “ L2” on one side and “ IT” on the other side.
Pilloli miksija b’ rita ta ’ forma tawwalija bojod jagħtu fl- offwajt, b’ inċiżjoni “ L2 ” fuq naħa waħda u “ IT ” fuq in- naħa l- oħra.
Bondronat is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Bondronat huwa indikat fil- prevenzjoni ta ’ effetti skeletriċi (fratturi patoloġiċi, komplikazzjonijiet fl - għadam li jeħtieġu r- radjuterapija jew il- kirurġija) f’ pazjenti b’ kanċer fis- sider u metastasi fl- għadam.
Bondronat therapy should only be initiated by physicians experienced in the treatment of cancer.
Terapija b’ Bondronat għandu jingħata biss minn tobba li għandhom esperjenza fil- kura tal- kanċer.
For oral use.
Għall- użu orali.
The recommended dose is one 50 mg film-coated tablet daily.
Id- doza rakkomandata hija pillola waħda miksija b' rita ta '50 mg kuljum.
Bondronat tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Pilloli ta ’ Bondronat għandhom jittieħdu wara s- sawma ta ’ bil- lejl (mill- inqas 6 sigħat) u qabel l - ewwel ikel jew xorb tal- ġurnata.
Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Bondronat tablets.
Prodotti u supplimenti mediċinali (inkluż il- kalċju) għandhom jiġu evitati qabel ma jittieħdu l- pilloli ta ’ Bondronat.
Fasting should be continued for at least 30 minutes after taking the tablet.
Is- sawma għandha tkompli għal mill- inqas 30 minuta wara li tieħu l- pillola.
Plain water may be taken at any time during the course of Bondronat treatment.
Ilma waħdu jista ’ jittieħed f’ kull ħin matul il- kors ta ’ trattament b’ Bondronat.
- The tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the
- Il- pilloli għandhom jinbelgħu sħaħ b’ tazza mimlija ilma waħdu (180 sa 240 ml) bil- pazjent bil -
patient is standing or sitting in an upright position.
wieqfa jew bil- qiegħda f’ qagħda wieqfa.
- Patients should not lie down for 60 minutes after taking Bondronat.
- Il- pazjenti m’ għandhomx jimteddu għal 60 minuta wara li jieħdu Bondronat.
- Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.
- Il- pazjenti m’ għandhomx jomogħdu jew jerdgħu il- pillola minħabba l- potenzjal ta ’ ulċera
- Plain water is the only drink that should be taken with Bondronat.
- Ilma waħdu huwa l- unika xarba li għandha tittieħed ma ’ Bondronat.
Please note that some mineral
Jekk jogħġbok oqgħod
waters may have a higher concentration of calcium and therefore should not be used.
attent li ċerti ilma minerali jista ’ jkollhom konċentrazzjoni ogħla ta ’ kalċju u għalhekk m’ għandhomx jintużaw.
Patients with hepatic impairment No dosage adjustment is required (see section 5.2).
14 Pazjenti b’ indeboliment tal- fwied L- ebda aġġustament fid- doża ma huwa meħtieġ (ara sezzjoni 5. 2).
14 No dosage adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal to or greater than 30 ml/ min.
Pazjenti b’ indeboliment tal- kliewi L- ebda aġġustament fid- doża ma hu neċessarju għall- pazjenti b’ indeboliment ħafif jew moderat tal - kliewi fejn ir- rata li biha jitneħħa l- kreatinina hija daqs jew aktar minn 30 ml/ min.
Below 30 ml/ min creatinine clearance, the recommended dose is 50 mg once weekly.
Meta r- rata li biha jitneħħa l- kreatinina hija anqas minn 30 ml/ min, id- doża rakkomandata hija 50 mg darba fil- ġimgħa.
See dosing instructions, above.
Ara struzzjonijiet dwar id- doża akar ‘ il fuq.
Elderly No dose adjustment is necessary.
L- anzjani L- ebda aġġustament fid- doża ma huwa neċessarju.
Children and adolescents Bondronat is not recommended for patients below age 18 years due to insufficient data on safety and efficacy.
Bondronat mhux rakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Hypersensitivity to ibandronic acid or to any of the excipients.
Sensitivita eċċessiva għal ibondronic acid jew għal xi wieħed mis- sustanzi mhux attivi.
Bondronat should not be used in children.
Bondronat m’ għandux jintuża fit- tfal.
Caution is indicated in patients with known hypersensitivity to other bisphosphonates.
Hija indikata l- kawtela f’ pazjenti b’ ipersensittività magħrufa għal bisfosfonati oħra.
Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Bondronat therapy.
Nuqqas ta ’ kalċju u disturbi oħra fil- metaboliżmu ta ’ l- għadam u l- minerali għandhom jiġu trattati effettivament qabel ma tinbeda terapija b’ Bondronat.
Oral bisphosphonates have been associated with dysphagia, oesophagitis and oesophageal or gastric ulcers.
Bisfosfonati orali kienu assoċjati ma ’ disfaġja, oseofaġite, u ulċeri oseofaġali jew gastriċi.
Therefore, patients should pay particular attention to the dosing instructions (see section 4.2).
Għalhekk, il- pazjenti għandhom joqogħdu attenti partikolarment għall- istruzzjonijiet dwar id- doża (ara sezzjoni 4. 2).