natgillin/translations-raw huggingface dataset:
The marketing authorisation was renewed on 25 June 2001 and on 25 June 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano 25. junija 2001 in 25. junija 2006.
The full EPAR for Bondronat is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Bondronat je na voljo tukaj.
EU Number
farmacevtska
Invented name
vsebina
Strength
velikost
Pharmaceutical Form
Številka EU
Route of Administration
Izmišljeno ime jakost 2 mg 1
Bondronat Bondronat
Bondronat 50 mg
50 mg 50 mg
Bondronat 50 mg 6 mg 1
blister (alu/ alu) blister (alu/ alu)
pretisni omot (alu/ alu)
28 tablets 84 tablets
84 tablet
6 mg 1
Bondronat 6 mg 1
1 1 ml of solution contains 1.125 mg ibandronic acid, monosodium salt, monohydrate, corresponding to 1mg ibandronic acid.
1 1 ml raztopine vsebuje 1, 125 mg ibandronske kisline v obliki monohidrata natrijeve soli, kar ustreza 1 mg ibandronske kisline.
Bondronat 2 mg Concentrate for solution for infusion
Bondronat 2 mg koncentrat za raztopino za infundiranje
One vial with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as 2.25 mg ibandronic acid, monosodium salt, monohydrate).
Ena viala z 2 ml koncentrata za raztopino za infundiranje vsebuje 2 mg ibandronske kisline (kot 2, 25 mg ibandronske kisline v obliki monohidrata natrijeve soli).
Clear, colourless solution.
Koncentrat za raztopino za infundiranje Bistra, brezbarvna raztopina
Bondronat is indicated for
Bondronat je indiciran za:
- Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy
- preprečevanje z okostjem povezanih dogodkov (patološke frakture; zapleti, pri katerih je
or surgery) in patients with breast cancer and bone metastases.
potrebno obsevanje ali kirurški poseg) pri bolnikih z rakom dojke in metastazami v kosteh.
- Treatment of tumour-induced hypercalcaemia with or without metastases.
- zdravljenje tumorsko povzročene hiperkalciemije z metastazami ali brez njih.
Only clear solution without particles should be used.
Uporabljamo lahko le bistro raztopino brez vidnih delcev.
Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh
For infusion, the contents of the vial(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.
A shorter (i. e.
Krajši čas infuzije (t. j.
There are no data available characterizing the use of a shorter infusion time in patients with creatinine clearance below 50 ml/ min.
Podatkov, ki bi označevali uporabo krajšega časa infuzije pri bolnikih z očistkom kreatinina pod 50 ml/ min, ni na voljo.
Prescribers should consult the section Patients with Renal Impairment (Section 4.2) for recommendations on dosing and administration in this patient group.
Pri tej skupini bolnikov morajo predpisovalci upoštevati navodila za odmerjanje in način uporabe iz poglavja Bolniki z ledvično okvaro (poglavje 4. 2).
Treatment of Tumour-Induced Hypercalcaemia
Zdravljenje tumorsko povzročene hiperkalciemije
Prior to treatment with Bondronat the patient should be adequately rehydrated with 9 mg/ ml (0.9%) sodium chloride.
Pred zdravljenjem z zdravilom Bondronat izvedemo ustrezno hidracijo bolnika z raztopino natrijevega klorida 9 mg/ ml (0, 9 -%).
In general patients with osteolytic bone metastases require lower doses than patients with
V splošnem potrebujejo bolniki z osteolitičnimi metastazami v kosteh manjše odmerke kot bolniki s humoralnim tipom hiperkalciemije.
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥ 3 mmol/ l or ≥ 12 mg/ dl) 4 mg is an adequate single dosage.
2 serumu * ≥ 3 mmol/ l ali ≥ 12 mg/ dl) zadošča enkratni odmerek 4 mg.
In patients with moderate hypercalcaemia (albumin-corrected serum calcium < 3 mmol/ l or < 12 mg/ dl) 2 mg is an effective dose.
Pri bolnikih z zmerno hiperkalciemijo (korigirani kalcij v serumu < 3 mmol/ l ali < 12 mg/ dl) je učinkovit odmerek 2 mg.
* Note albumin-corrected serum calcium concentrations are calculated as follows:
* Opomba: koncentracije korigiranega kalcija v serumu izračunamo po naslednji formuli:
Albumin-corrected serum calcium (mmol/ l)
korigirani kalcij v serumu (mmol/ l)
serum calcium (mmol/ l) - [0.02 x albumin (g/ l)] + 0.8
koncentracija kalcija v serumu (mmol/ l) – [0, 02 x albumin (g/ l)] + 0, 8
Albumin-corrected serum calcium (mg/ dl)
korigirani kalcij v serumu (mg/ dl)
serum calcium (mg/ dl) + 0.8 x [4 - albumin (g/ dl)]
koncentracija kalcija v serumu (mg/ dl) + 0, 8 x [4 – albumin (g/ 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.
The median time to relapse (return of albumin-corrected serum calcium to levels above 3 mmol/ l) was 18 - 19 days for the 2 mg and 4 mg doses.
Mediana časa do relapsa (ponovnega zvišanja korigiranega kalcija v serumu nad 3 mmol/ l) je bila 18 do 19 dni pri 2 mg in 4 mg odmerkih.
For this purpose, the contents of the vials are to be added to 500 ml isotonic sodium chloride solution (or 500 ml 5% dextrose solution) and infused over two hours.
V ta namen dodamo vsebino vial k 500 ml izotonične raztopine natrijevega klorida (ali k 500 ml 5 -% raztopine glukoze) in infundiramo 2 uri.
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 Zdravilo Bondronat dajemo intravensko.
Patients with hepatic impairment No dosage adjustment is required (see section 5.2).
Bolniki z jetrno okvaro Prilagajanje odmerkov ni potrebno (glejte poglavje 5. 2).
Patients with renal impairment There is no evidence of a reduction in tolerability associated with an increase in exposure to ibandronate in patients with various degrees of renal impairment.
Bolniki z ledvično okvaro Pri bolnikih z različnimi stopnjami ledvične okvare ni dokazov o zmanjšanem prenašanju zdravila zaradi povečane izpostavljenosti ibandronatu.
However, for the prevention of skeletal events in patients with breast cancer and bone metastases the following recommendations should be followed:
Vendar je treba pri bolnikih z rakom dojke in metastazami v kosteh upoštevati naslednja priporočila, da se prepreči z okostjem povezane dogodke:
Dosage / Infusion time 1
odmerjanje / čas infuzije 1
Infusion Volume 2
volumen infuzije 2
6 mg / 15 minutes
6 mg / 15 minut
1
6 mg / 1 ura
30 < CLcr < 50 < 30
500 ml
6 mg / 1 hour 2 mg / 1 hour
1
Administration every 3 to 4 week 2 0.9% sodium chloride solution or 5% glucose solution
0, 9 -% raztopina natrijevega klorida ali 5 -% raztopina glukoze
A 15 minute infusion time has not been studied in cancer patients with CLCr < 50 mL/ min.
15 minutne infuzije pri bolnikih z rakom, ki imajo očistek kreatinina < 50 ml/ min, niso proučevali.
Elderly No dose adjustment is required.
Starejši bolniki Prilagajanje odmerkov ni potrebno.
3 Children and adolescents Bondronat is not recommended for patients below age 18 years due to insufficient data on safety and efficacy.
3 Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Bondronat pri otrocih pod 18 let ni priporočljiva.
Caution is to be taken in patients with known hypersensitivity to other bisphosphonates.
Previdnost je potrebna pri bolnikih z znano preobčutljivostjo za druge bisfosfonate.
Bondronat should not be used in children.
Zdravila Bondronat pri otrocih ne smemo uporabljati.
Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Bondronat.
Vseeno pa je glede na klinično oceno posameznega bolnika pri zdravljenju z zdravilom Bondronat priporočljivo spremljati delovanje ledvic, serumski kalcij, fosfat in magnezij.
As no clinical data are available, dosage recommendations cannot be given for patients with severe hepatic insufficiency.
Ker za bolnike s težko insuficienco jeter klinični podatki niso na voljo, za to skupino bolnikov ne moremo dati priporočil o odmerjanju.
Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Bondronat therapy for metastatic bone disease.
Pred začetkom zdravljenja metastatične bolezni kosti z zdravilom Bondronat je hipokalciemijo in druge motnje kosti in presnove mineralov treba učinkovito zdraviti.
Patients should receive supplemental calcium and/ or vitamin D if dietary intake is inadequate.
Če je vnos s hrano nezadosten, morajo bolniki prejeti dodatke kalcija ali vitamina D ali oboje.
Osteonecrosis of the jaw, generally associated with tooth extraction and/ or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Pri bolnikih z rakom, ki so prejemali zdravljenje, ki je prvenstveno vključevalo bisfosfonate, dane intravensko, so poročali o osteonekrozi čeljusti, po navadi povezani z izdrtjem zoba ali lokalno okužbo (vključno z osteomielitisom) ali obojim.
Bondronat should not be mixed with calcium containing solutions
Zdravila Bondronat ne smemo mešati z drugimi raztopinami, ki vsebujejo kalcij.
No interaction was observed when co-administered with melphalan/ prednisolone in patients with multiple myeloma.
Pri sočasnem jemanju z melfalanom ali prednizolonom ali obojim pri bolnikih z multiplim mielomom medsebojnega delovanja niso opazili.
Other interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (oestrogen).
Druge študije medsebojnega delovanja pri ženskah v postmenopavzi so pokazale, da s tamoksifenom ali hormonskim nadomestnim zdravljenjem (estrogenom) ne prihaja do medsebojnega delovanja.
4 In relation to disposition, no drug interactions of clinical significance are likely.
4 Glede na razpoložljive podatke klinično pomembna medsebojna delovanja niso verjetna.
Ibandronic acid is eliminated by renal secretion only and does not undergo any biotransformation.
Ibandronska kislina se izloča le prek ledvic in ni podvržena biotransformaciji.
The secretory pathway does not appear to include known acidic or basic transport systems involved in the excretion of otheractive substances.
Zdi se, da pot izločanja ne vključuje znanih kislinskih ali bazičnih transportnih sistemov, ki sodelujejo pri izločanju drugih zdravilnih učinkovin.
In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Ibandronska kislina pri ljudeh ne zavira glavnih humanih jetrnih izoencimov P450 in ne povzroča indukcije jetrnega sistema citokroma P450 pri podganah.
Plasma protein binding is low at therapeutic concentrations and ibandronic acid is therefore unlikely to displace other active substances.
Vezava na plazemske beljakovine je pri terapevtskih koncentracijah majhna, zato ni verjetno, da bi ibandronska kislina izpodrivala druge zdravilne učinkovine.
Caution is advised when bisphosphonates are administered with aminoglycosides, since both agents can lower serum calcium levels for prolonged periods.
Pri sočasnem jemanju bisfosfonatov z aminoglikozidi je potrebna previdnost, ker lahko obe učinkovini znižata koncentracijo kalcija v serumu za daljše obdobje.
In clinical studies, Bondronat has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
V kliničnih študijah so zdravilo Bondronat dajali sočasno s pogosto uporabljanimi zdravili proti raku, diuretiki, antibiotiki in analgetiki, ne da bi prišlo do klinično očitnega medsebojnega delovanja.
Studies in rats have shown reproductive toxicity (see section 5.3).
Študije na podganah so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
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%).
Neželeni učinki so razvrščeni v poglavja glede na pogostnost, in sicer od najbolj do najmanj pogostih: zelo pogosti (≥ 10%), pogosti (≥ 1% in < 10%), občasni (≥ 0, 1% in < 1%), redki (≥ 0, 01% in < 0, 1%) in zelo redki (≤ 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.
Zdravljenje tumorsko povzročene hiperkalciemije Podatki o varnostnem profilu zdravila Bondronat pri tumorsko povzročeni hiperkalciemiji izhajajo iz kontroliranih kliničnih preskušanj pri tej indikaciji in po intravenskem dajanju zdravila Bondronat v priporočenih odmerkih.
Treatment was most commonly associated with a rise in body temperature.
Zdravljenje je bilo najpogosteje povezano z zvišanjem telesne temperature.
Occasionally, a flu- like syndrome consisting of fever, chills, bone and/ or muscle ache-like pain was reported.
Občasno se je pojavil gripi podoben sindrom, ki so ga spremljali vročina, mrzlica, bolečine v kosteh in mišicah.
In most cases no specific treatment was required and the symptoms subsided after a couple of hours/ days.
V večini primerov posebno zdravljenje ni bilo potrebno, simptomi so izginili po nekaj urah ali dneh.
Table 1 lists adverse reactions recorded in the trials (events were recorded irrespective of a determination of causality).
V preglednici 1 so našteti neželeni učinki, ki so jih poročali v kliničnih preskušanjih (dogodke so poročali ne glede na določeno vzročnost).
Number (percentage) of Patients Reporting Adverse Reactions in Controlled Clinical Trials in Tumour-Induced Hypercalcaemia after Treatment with Bondronat
Število (odstotek) bolnikov, pri katerih so se v kontroliranih kliničnih preskušanjih tumorsko povzročene hiperkalciemije po zdravljenju z zdravilom Bondronat pojavili neželeni učinki.
Class / Adverse reaction Frequency Number (%) (n=352)
Organski sistem/ neželeni učinek Presnovne in prehranske motnje:
Metabolism and nutrition disorders Common:
Pogostnost, število (%) (n = 352)
Hypocalcaemia
pogosti: hipokalciemija
Frequency Number (%) (n=352)
Bolezni mišično- skeletnega sistema in vezivnega tkiva: pogosti: občasni:
Bone Pain Uncommon:
bolečina v kosteh mialgija
General disorders and administration site conditions:
Splošne težave in spremembe na mestu aplikacije: zelo pogosti: pireksija občasni: gripi podobna bolezen rigorji
Data for both the 2 mg and 4 mg doses of ibandronic acid are pooled.
Opomba: podatki za 2- mg in 4- mg odmerke ibandronske kisline so združeni.
Events were recorded irrespective of a determination of causality.
Dogodke so zabeležili ne glede na njihov vzrok.
Frequently, decreased renal calcium excretion is accompanied by a fall in serum phosphate levels not requiring therapeutic measures.
Zmanjšano renalno izločanje kalcija pogosto spremlja padec koncentracije fosfata v serumu, kar pa ne zahteva zdravljenja.
Other reactions reported at lower frequency are as follows:
Drugi učinki, ki so jih opazili manj pogosto, so:
Very rare:
Bolezni imunskega sistema: zelo redki: preobčutljivost
Very rare:
Bolezni kože in podkožja: zelo redki: angionevrotični edem
Very rare:
Bolezni dihal, prsnega koša in mediastinalnega prostora: zelo redki: bronhospazem
of other bisphosphonates has been associated with broncho-constriction in
Dajanje drugih bisfosfonatov so povezovali z bronhokonstrikcijo pri astmatičnih bolnikih, ki so občutljivi za acetilsalicilno kislino.
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.
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh Podatki o varnostnem profilu zdravila Bondronat, danega intravensko pri bolnikih z rakom dojke in metastazami v kosteh, izhajajo iz kontroliranega kliničnega preskušanja pri tej indikaciji in po intravenskem dajanju zdravila Bondronat v priporočenem odmerku.
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 dogodki 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 kosti zaradi raka dojke, zdravljenih z zdravilom Bondronat 6 mg, danim intravensko, pojavili pogosto in večkrat v primerjavi s placebom.
Placebo (n = 157) No.
Neželeni učinek
(%)
Placebo Bondronat 6 mg (n = 157), (n = 152), število (%) število (%)
Infections and Infestations:
Infekcijske in parazitske bolezni:
Nervous
Bolezni endokrinega sistema:
Parathyroid disorder System disorders:
okvara ščitnice
Headache Dizziness Dysgeusia (taste perversion)
Bolezni živčevja:
4 (2.5) 2 (1.3) 0 (0.0)
4 (2, 5) 2 (1, 3) 0 (0, 0)
9 (5.9) 4 (2.6) 2 (1.3)
9 (5, 9) 4 (2, 6) 2 (1, 3)
6 Adverse Reaction
Očesne bolezni:
Placebo
2 (1, 3)
Bondronat 6mg
Neželeni učinek
(n = 157) No.
(n = 157),
(n = 152) No.
(n = 152),
(%)
Srčne
Cataract Cardiac disorders:
bolezni:
1 (0.6)
število (%)
2 (1.3)
število (%)
Bundle branch block Respiratory, thoracic and mediastinal disorders:
kračni blok
Pharyngitis Gastrointestinal disorders:
Bolezni dihal, prsnega koša in mediastinalnega prostora:
Diarrhoea Dyspepsia Vomiting Gastrointestinal pain Tooth disorder Skin and subcutaneous tissue disorders:
diareja dispepsija bruhanje gastrointestinalna bolečina bolezen zob
Skin disorder Ecchymosis Musculoskeletal and connective tissue disorders:
Bolezni kože in podkožja:
Myalgia Arthralgia Joint disorder Osteoarthritis General disorders:
Bolezni mišično- skeletnega sistema in vezivnega tkiva:
Asthenia Influenza-like illness Oedema peripheral Thirst Investigations:
Splošne težave:
Gamma-GT increased Creatinine increased
zvišana γ- GT zvišan kreatinin
Other adverse reactions reported at a lower frequency are as follows:
Drugi neželeni učinki, o katerih so poročali manj pogosto, so navedeni spodaj:
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 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
7 Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Pri bolnikih, zdravljenih z bisfosfonati, so poročali o osteonekrozi čeljusti.
The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Osteonekroza čeljusti
Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
7 je navadno povezana z izdrtjem zoba ali lokalno okužbo (vključno z osteomielitisom) ali obojim.
Pharmaco-therapeutic group:
Farmakoterapevtska skupina: bisfosfonati.
Bisphosphonate, ATC Code:
Oznaka ATC:
Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone.
Ibandronska kislina pripada skupini bisfosfonatov, ki specifično delujejo na kosti.
Their selective action on bone tissue is based on the high affinity of bisphosphonates for bone mineral.
Selektivno delovanje bisfosfonatov na kostno tkivo temelji na njihovi veliki afiniteti do mineralizirane kosti.
Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear.
Bisfosfonati zavirajo osteoklastno aktivnost, natančen mehanizem pa še vedno ni jasen.
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 pokazale, 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.
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.
V razponih odmerkov, priporočenih za zdravljenje, so med kliničnimi preskušanji za bolnike, ki so pred začetkom zdravljenja imeli korigirani kalcij v serumu ≥ 3, 0 mmol/ l po ustrezni rehidraciji, ugotovili naslednje hitrosti odziva in intervale zaupanja.
78 86 100%
8% odzivnih bolnikov
ibandronic ac id dos e
odmerek ibandronske kisline
high 90%
visok 90% interval hitrost odziva
res pons e rat e
zaupanja
low 90% c onf idenc e int erv al
nizek 90% interval zaupanja
The median time to relapse (return of albumin-corrected serum calcium above 3.0 mmol/ l) was 18 to 26 days.
Mediana časa do relapsa (ponovnega zvišanja korigiranega kalcija v serumu nad 3, 0 mmol/ l) je bila 18 do 26 dni.