natgillin/translations-raw huggingface dataset:
Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear.
Bisfosfonati zavirajo osteoklastno aktivnost, natančni mehanizem pa še vedno ni jasen.
Prevention of skeletal events in patients with breast cancer and bone metastases with Bondronat 50 mg tablets was assessed in two randomized placebo controlled phase III trials with duration of 96 weeks.
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh s tabletami Bondronat 50 mg so raziskovali v dveh randomiziranih, s placebom kontroliranih preskušanjih faze III, ki so potekala 96 tednov.
Primary Efficacy Endpoints The primary endpoint of the trials was the skeletal morbidity period rate (SMPR).
Primarni cilj raziskave učinkovitosti Primarni cilj raziskave je bil stopnja hitrosti obolevnosti okostja (SMPR – skeletal morbidity period rate).
- non-vertebral fractures
- nevertebralne frakture.
Multiple events were therefore, counted only once in any given 12 week period for the purposes of the analysis.
Večkratni dogodki so bili za namen analize upoštevani le enkrat v kateremkoli 12- tedenskem obdobju.
Pooled data from these studies demonstrated a significant advantage for Bondronat 50 mg p. o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Združeni podatki teh študij so pokazali značilno prednost zdravila Bondronat 50 mg, danega peroralno, pred placebom v zmanjšanju SRE, ki so jih merili s SMPR (p = 0, 041).
There was also a 38% reduction in the risk of developing an SRE for Bondronat treated patients when compared with placebo (relative risk 0.62, p=0.003).
V primerjavi s placebom je bilo tveganje za nastanek SRE pri bolnikih, zdravljenih z zdravilom Bondronat, za 38% manjše (relativno tveganje 0, 62, p = 0, 003).
Efficacy results are summarised in Table 2.
Preglednica 2.
Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Rezultati učinkovitosti (bolniki z rakom dojke z metastatično boleznijo kosti).
All Skeletal Related Events (SREs) Placebo Bondronat 50 mg p-value n=277 n=287
vsi z okostjem povezani dogodki (SREs) Placebo Bondronat 50 mg p- vrednost n = 277 n = 287
p=0.041
1, 15 0, 99 p = 0, 041
Secondary Efficacy Endpoints A statistically significant improvement in bone pain score was shown for Bondronat 50 mg compared to placebo.
Sekundarni cilji raziskave učinkovitosti V primerjavi s placebom se je pri zdravilu Bondronat 50 mg pokazalo statistično značilno izboljšanje rezultata pri bolečinah v kosteh.
Urinary concentrations of the bone resorption marker CTx (C-terminal telopeptide released from Type I collagen) were significantly reduced in the Bondronat group compared to placebo.
Koncentracije označevalca resorpcije kosti CTx (C- terminalni telopeptid, ki se sprosti s kolagena tipa I) v seču so bile v skupini zdravljeni z zdravilom Bondronat v primerjavi s placebom značilno znižane.
This reduction in urinary CTx levels was significantly correlated with the primary efficacy endpoint SMPR (Kendall-tau-b (p < 0.001)).
Znižanje koncentracij CTx v seču je bilo značilno v korelaciji s primarnim ciljem raziskave učinkovitosti SMPR (Kendall- tau- b (p < 0, 001)).
Table 3
Preglednica 3.
Secondary Efficacy Results (Breast Disease)
Sekundarni rezultati učinkovitosti (bolniki z rakom dojke z metastatično boleznijo kosti).
Bondronat 50 mg p-value n=287
Placebo Bondronat 50 mg p- vrednost n = 277 n = 287
Bone pain *
bolečina v kosteh *
-26.8
– 26, 8
-8.3
– 8, 3
WHO performance score *
status učinka po SZO *
Urinary CTx **
koncentracija CTx v seču **
-77.32
– 77, 32
* Mean change from baseline to last assessment. ** Median change from baseline to last assessment
* Povprečna sprememba od začetne do zadnje ocene. ** Mediana spremembe od začetne do zadnje ocene.
Absorption The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration.
19 Absorpcija Po peroralnem jemanju je absorpcija ibandronske kisline v zgornjem delu gastrointestinalnega trakta hitra.
Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6%.
Najvišje plazemske koncentracije so bile med postom dosežene v obdobju od 0, 5 do 2 ur (mediana časa 1 ura), absolutna biološka uporabnost je bila okoli 0, 6%.
The extent of absorption is impaired when taken together with food or beverages (other than plain water).
Obseg absorpcije je pri sočasnem jemanju hrane ali pijače (druge kot navadna pitna voda) zmanjšan.
When taken 30 minutes before a meal, the reduction in
Pri sočasnem jemanju ibandronske kisline s standardnim zajtrkom se biološka uporabnost zmanjša za okoli 90% v primerjavi z biološko uporabnostjo, ki so jo opazili pri bolnikih po postu.
19 bioavailability is approximately 30%.
Pri jemanju 30 minut pred obrokom, je zmanjšanje biološke uporabnosti približno 30 -%.
Bioavailability was reduced by approximately 75% when Bondronat tablets were administered 2 hours after a standard meal.
Ko so tablete Bondronat dali 2 uri po standardnem obroku, se je biološka uporabnost zmanjšala za 75%.
Therefore, it is recommended that the tablets should be taken after an overnight fast (minimum 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see Section 4.2).
Zato je priporočljivo, da bolnik vzame tablete po postu prek noči (post naj traja najmanj 6 ur), po vzetem odmerku pa mora miniti vsaj 30 minut, preden bolnik zaužije pijačo ali hrano (glejte poglavje 4. 2).
In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50% of the circulating dose.
Pri ljudeh znaša navidezni terminalni volumen porazdelitve najmanj 90 l, količina odmerka, ki doseže kosti, je ocenjena na 40 do 50% odmerka, ki je v krvnem obtoku.
Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus drug-drug interaction due to displacement is unlikely.
Vezava na plazemske beljakovine pri ljudeh je pri terapevtskih koncentracijah približno 87 -%, zato so medsebojna delovanja med zdravili zaradi izpodrivanja malo verjetna.
Elimination The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50%) and the remainder is eliminated unchanged by the kidney.
Izločanje Absorbiran delež ibandronske kisline se iz sistemskega krvnega obtoka odstrani z absorpcijo v kostno tkivo (predvidoma 40 do 50%), preostanek pa se nespremenjen izloči skozi ledvice.
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.
Navidezni terminalni razpolovni čas je v splošnem v razponu od 10 do 60 ur.
However, early plasma levels fall quickly, reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Zgodnje plazemske koncentracije hitro padejo, 10% največje vrednosti dosežejo 3 ure po intravenskem dajanju in 8 ur po peroralnem dajanju.
No dosage adjustment is necessary for patients with mild or moderate renal impairment (CLcr > 30 ml/ min).
Za bolnike z blago ali zmerno ledvično okvaro (CLcr > 30 ml/ min) prilagajanje odmerkov ni potrebno.
Subjects with severe renal impairment (CLcr ≤ 30 ml/ min) receiving oral administration of 10 mg ibandronic acid daily for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function.
Bolniki s hudo motnjo ledvičnega delovanja (CLcr ≤ 30 ml/ min), ki so peroralno prejemali 10 mg ibandronske kisline na dan 21 dni, so imeli 2 do 3- krat višje plazemske koncentracije kot osebe z normalno ledvično funkcijo.
Total clearance of ibandronic acid was reduced to 44 ml/ min in the subjects with severe renal impairment.
Celokupni očistek ibandronske kisline je bil pri bolnikih s hudo ledvično okvaro zmanjšan na 44 ml/ min.
After intravenous administration of 0.5 mg, total, renal, and non-renal clearances decreased by 67%, 77% and 50%, respectively, in subjects with severe renal impairment.
20 odmerka 0, 5 mg se je pri bolnikih s hudo ledvično okvaro celokupni očistek zmanjšal za 67%, ledvični očistek za 77%, neledvični očistek pa za 50%.
However, there was no reduction in tolerability associated with the increase in exposure.
Zaradi povečane izpostavljenosti pa ni prišlo do zmanjšanja prenašanja zdravila.
Reduction of the oral dose to one 50 mg tablet once weekly is recommended in patients with severe renal impairment (CLcr < 30 ml/ min) (see Section 4.2).
Pri bolnikih s hudo ledvično okvaro (CLcr < 30 ml/ min) je priporočljivo zmanjšanje peroralnega odmerka na eno 50- mg tableto enkrat na teden (glejte poglavje 4. 2).
Patients with hepatic impairment There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Bolniki z jetrno okvaro Pri bolnikih z jetrno okvaro za ibandronsko kislino ni farmakokinetičnih podatkov.
20 cleared by renal excretion and by uptake into bone.
Jetra niso pomembna za očistek ibandronske kisline, ker se ne presnavlja, ampak izloča z renalno ekskrecijo in vstopanjem v kostno tkivo.
Elderly In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Starejši bolniki Večvariantna analiza je pokazala, da starost med vsemi preskušanimi farmakokinetičnimi parametri ni neodvisen dejavnik.
Children and adolescents There are no data on the use of Bondronat in patients less than 18 years old.
Otroci in mladostniki O uporabi zdravila Bondronat pri bolnikih, mlajših od 18 let, ni podatkov.
Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those expected for this class of drugs (bisphosphonates).
Neželeni učinki ibandronske kisline v študijah vplivov na sposobnost za razmnoževanje pri podganah so bili pričakovano značilni za to vrsto zdravil (bisfosfonati).
Lactose monohydrate Povidone Cellulose, microcrystalline Crospovidone Stearic acid Silica, anhydrous colloidal
Jedro tablete: monohidrat laktoze povidon mikrokristalna celuloza krospovidon stearinska kislina brezvoden koloidni silicijev dioksid
Tablet coat:
Obloga tablet: hipromeloza titanov dioksid E 171 smukec
Hypromellose Titanium dioxide E171 Talc Macrogol 6000
21 makrogol 6000
21 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
Bondronat 6 mg Concentrate for solution for infusion
Bondronat 6 mg koncentrat za raztopino za infundiranje
One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid, (as 6.75 mg ibandronic acid monosodium salt, monohydrate)
Ena viala s 6 ml koncentrata za raztopino za infundiranje vsebuje 6 mg ibandronske kisline (kot 6, 75 mg ibandronske kisline v obliki monohidrata natrijeve soli).
- Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy
- preprečevanje z okostjem povezanih dogodkov (patološke frakture, zapleti, pri katerih je
For infusion, the contents of the vials(s) should only be added to 100 ml isotonic sodium chloride solution or 100 ml 5% glucose solution.
Za infuzijo dodamo vsebino vial le k 100 ml izotonične raztopine natrijevega klorida ali k 100 ml 5 -% raztopine glukoze.
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥ 3 mmol/ l or ≥ 12 mg/ dl) 4 mg is an adequate single dosage.
23 serumu * ≥ 3 mmol/ l ali ≥ 12 mg/ dl) zadošča enkratni odmerek 4 mg.
Albumin-corrected Serum calcium (mmol/ l)
korigirani kalcij v serumu (mmol/ l)
Or Albumin-corrected Serum calcium (mg/ dl)
korigirani kalcij v serumu (mg/ dl)
To convert the albumin-corrected serum calcium in mmol/ l value to mg/ dl, multiply by 4.
Če želimo korigirani kalcij v serumu, izražen v mmol/ l pretvoriti v mg/ dl, vrednost pomnožimo s 4.
As the inadvertent intra-arterial administration of preparations not expressly recommended for this purpose as well as paravenous administration can lead to tissue damage, care must be taken to ensure that Bondronat concentrate for solution for infusion is administered intravenously.
Paziti je treba, da koncentrat za raztopino za infundiranje Bondronat dajemo intravensko.
6 mg / 1 hour 2 mg / 1 hour
6 mg / 1 ura 2 mg / 1 ura
Administration every 3 to 4 week 2 0.9% sodium chloride solution or 5% glucose solution
dajanje vsake 3 do 4 tedne 2 0, 9 -% raztopina natrijevega klorida ali 5 -% raztopina glukoze
24 Children and adolescents Bondronat is not recommended for patients below age 18 years due to insufficient data on safety and efficacy.
24 Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Bondronat pri otrocih pod 18 let ni priporočljiva.
Bondronat should not be used in children.
Zdravila Bondronat ne smemo uporabljati pri otrocih.
Patients should receive supplemental calcium and/ or vitamin D if dietary intake is inadequate.
Če je s hrano vnos nezadosten, morajo bolniki prejeti dodatke kalcija ali vitamina D ali oboje.
25 In relation to disposition, no drug interactions of clinical significance are likely.
25 Glede na razpoložljive podatke klinično pomembna medsebojna delovanja niso verjetna.
No studies on the effects on the ability to drive and use machines have been performed.
Študije o vplivu na sposobnost za vožnjo in upravljanje s stroji niso bile izvedene.
Class / Adverse reaction Frequency Number (%) (n=352)
Organski sistem/ neželeni učinek
26 System Organ Class / Adverse reaction
26 Organski sistem/ neželeni učinek Presnovne in prehranske motnje:
Frequency
Pogostnost, število (%) (n = 352)
Uncommon:
pogosti: hipokalciemija
Bone Pain Myalgia
10 (2, 8)
6 (1.7) 1 (0.3)
Bolezni mišično- skeletnega sistema in vezivnega tkiva:
General disorders and administration site conditions:
pogosti: bolečina v kosteh manj pogosti: mialgija
Very common:
6 (1, 7) 1 (0, 3)
Pyrexia Uncommon:
Splošne težave in spremembe na mestu aplikacije: zelo pogosti: manj pogosti:
Influenza-like illness Rigors
pireksija gripi podobna bolezen rigorji
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.
Neželeni učinki so bili malo verjetno, možno ali verjetno povezani s preskušanim zdravilom.
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
Neželeni učinki, ki so se pri bolnikih z metastatično boleznijo v kosti zaradi raka dojke, zdravljenih z zdravilom Bondronat 6 mg, danim intravensko, pojavili pogosto in večkrat v primerjavi s placebom.
27 Adverse Reaction
27 Neželeni učinek
(%)
število (%)
Cataract Cardiac disorders:
katarakta Srčne bolezni:
Bundle branch block Respiratory, thoracic and mediastinal disorders:
kračni blok Bolezni dihal, prsnega koša in mediastinalnega prostora:
Pharyngitis Gastrointestinal disorders:
faringitis Bolezni prebavil:
Diarrhoea Dyspepsia Vomiting Gastrointestinal pain Tooth disorder Skin and subcutaneous tissue disorders:
diareja dispepsija bruhanje gastrointestinalna bolečina bolezen zob Bolezni kože in podkožja:
Skin disorder Ecchymosis Musculoskeletal and connective tissue disorders:
bolezen kože ehimoza Bolezni mišično- skeletnega sistema in vezivnega tkiva:
Myalgia Arthralgia Joint disorder Osteoarthritis General disorders:
mialgija artralgija bolezen sklepov osteoartritis Splošne težave:
Asthenia Influenza-like illness Oedema peripheral Thirst Investigations:
astenija gripi podobna bolezen periferni edem žeja Preiskave:
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
Infekcijske in parazitske bolezni: cistitis, vaginitis, kandidoza v ustih Benigne in maligne neoplazme (vključno s cistami in polipi): benigna kožna neoplazma Bolezni krvi in limfatičnega sistema: anemija, diskrazija krvi Presnovne in prehranske motnje: hipofosfatemija Psihiatrične motnje: motnje spanca, anksioznost, čustvena labilnost Bolezni živčevja: cerebrovaskularna bolezen, lezija živčnih korenov, amnezija, migrena, nevralgija, hipertonija, hiperastezija, parestezija okoli ust, parozmija Ušesne bolezni, vključno z motnjami labirinta: gluhota Srčne bolezni: srčnomišična ishemija, kardiovaskularna bolezen, palpitacije Žilne bolezni: hipertenzija, limfni edem, krčne žile Bolezni dihal, prsnega koša in mediastinalnega prostora: pljučni edem, stridor Bolezni prebavil: gastroenteritis, disfagija, gastritis, ulceracija ust, heilitis Bolezni jeter, žolčnika in žolčevodov: holelitiaza Bolezni kože in podkožja: osip, plešavost Bolezni sečil: zastajanje seča, ledvična cista Motnje reprodukcije in dojk: bolečine v medenici
28 Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
28 Splošne težave in spremembe na mestu aplikacije: hipotermija Preiskave: zvišane koncentracije alkalne fosfataze v krvi, znižanje telesne mase Poškodbe in zastrupitve: poškodba, bolečina na mestu injiciranja
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.
Klinične študije zdravljenja tumorsko povzročene hiperkalciemije Klinične študije hiperkalciemije zaradi malignosti so pokazala, da je za zaviralni učinek ibandronske kisline na tumorsko povzročeno osteolizo in še posebno na hiperkalciemijo, povzročeno s tumorjem, značilno znižanje serumskega kalcija in zmanjšano izločanje kalcija z urinom.
78 86 100%
29% odzivnih bolnikov
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.
Klinične študije preprečevanja z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh Klinične študije pri bolnikih z rakom dojke in metastazami v kosteh so pokazale, da je zaviralni učinek na osteolizo kosti odvisen od odmerka, ki se izraža z označevalci resorpcije kosti ter da so dogodki povezani z okostjem odvisni od odmerka.
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.
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh z zdravilom Bondronat 6 mg, danim intravensko, so raziskovali v randomiziranem s placebom kontroliranim preskušanju faze III, ki je potekala 96 tednov.
- radiotherapy to bone for treatment of fractures/ impending fractures
- zdravljenje kosti z obsevanjem zaradi fraktur/ preteče frakture,
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).
Podatki raziskave so pokazali značilno prednost zdravila Bondronat 6 mg, danega intravensko, pred placebom v zmanjšanju SRE, ki so jih merili s SMPR (p = 0, 004).
30 Table 3
30 Preglednica 3.
cancer Patients with Metastatic Bone Disease)
Sekundarni rezultati učinkovitosti (bolniki z rakom dojke in metastatično boleznijo kosti).
Bondronat 6 mg p-value n=154
Placebo Bondronat 6 mg p- vrednost n = 158 n = 154
-0.28 p < 0.001
* 0, 21 – 0, 28 p < 0, 001
Protein binding in human plasma is
Vezava na
31 approximately 87% at therapeutic concentrations, and thus drug-drug interaction due to displacement is unlikely.
31 plazemske beljakovine pri ljudeh je pri terapevtskih koncentracijah približno 87 -%, zato so medsebojna delovanja med zdravili zaradi izpodrivanja malo verjetna.
Children and adolescents There are no data on the use of Bondronat in patients less than 18 years old
Otroci in mladostniki O uporabi zdravila Bondronat pri bolnikih, mlajših od 18 let, ni zadostnih podatkov.
32 Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
32 Predklinične učinke so opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
Mutagenicity/ Carcinogenicity:
Mutagenost in kancerogeni potencial:
Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vial).
Zdravilo Bondronat je na voljo v škatlah, v katerih je 1, 5 ali 10 vial (6 ml viale iz stekla tipa I).
The vials are closed with rubber stoppers complying with Ph. Eur.
Viale so zaprte z gumijastim zamaškom v skladu s Ph. Eur.
Not all pack sizes may be marketed..
Na trgu ni vseh navedenih pakiranj.
34 ANNEX II
34 DODATEK II
Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany
Roche Diagnostics GmbH Sandhofer Strasse 116 D- 68305 Mannheim Nemčija
1 D-79639 Grenzach-Wyhlen Germany
1 D- 79639 Grenzach- Wyhlen Nemčija
36 ANNEX III
36 DODATEK III
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
38 PODATKI NA ZUNANJI OVOJNINI
Each vial contains 2 mg of ibandronic acid (as monosodium salt, monohydrate).
Vsaka viala vsebuje 2 mg ibandronske kisline v obliki monohidrata natrijeve soli.
Intravenous use, for infusion after dilution.
Za infundiranje po razredčitvi.
After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)
Po razredčitvi je infuzijska raztopina stabilna 24 ur pri temperaturi med 2 °C in 8 °C (v hladilniku)
EU/ 1/ 96/ 012/ 004
EU71/ 96/ 012/ 004
40 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
40 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Bondronat 2 mg concentrate for solution for infusion ibandronic acid I. V. use
Bondronat 2 mg koncentrat za raztopino za infundiranje ibandronska kislina i. v. uporaba
Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronic sodium monohydrate).
Vsaka filmsko obložena tableta vsebuje 50 mg ibandronske kisline (v obliki natrijevega ibandronat monohidrata).
Lactose monohydrate, Povidone, Cellulose (microcrystalline), Crospovidone, Stearic acid, Silica (anhydrous colloidal), Hypromellose, Titanium dioxide E171, Talc, Macrogol 6000.
Monohidrat laktoze, povidon, celuloza (mikrokristalna), krospovidon, stearinska kislina, silicijev dioksid (brezvoden koloidni), hipromeloza, titanov dioksid E171, smukec, makrogol 6000.
Oral use Do not suck or chew tablets Read the package leaflet before use
Peroralna uporaba Tablet ne sesajte ali žvečite Pred uporabo preberite priloženo navodilo
The tablets also contain lactose
Tablete vsebujejo tudi laktozo
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
45 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Mon Tue Wed Thu Fri Sat Sun
Ned.
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton
46 PODATKI NA ZUNANJI OVOJNINI
Each vial contains 6 mg of ibandronic acid (as monosodium salt, monohydrate).
Vsaka viala vsebuje 6 mg ibandronske kisline (v obliki monohidrata natrijeve soli).
No special storage requirements prior to reconstitution.
Za shranjevanje pred rekonstitucijo niso potrebna posebna navodila.
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
48 PODATKI NA ZUNANJI OVOJNINI