natgillin/translations-raw huggingface dataset:
Less frequently, a decrease in serum calcium below normal range (hypocalcaemia) is reported.
Manj pogosto poročajo o znižanju serumskega kalcija pod spodnjo mejo normale
Subjects with severe renal impairment (CLcr less than 30 ml/min) receiving daily oral administration of 10 mg ibandronic acid for 21 days, had 2 - 3 fold higher plasma concentrations than subjects with normal renal function and total clearance of ibandronic acid was 44 ml/min.
Bolniki s hudo motnjo ledvičnega delovanja (CLcr manjši kot 30 ml/min), ki so prejemali peroralno 10 mg ibandronske kisline na dan 21 dni, so imeli 2- do 3-krat višje plazemske koncentracije kot osebe z normalno ledvično funkcijo.
After intravenous administration of 0.5 mg of ibandronic acid, total, renal, and non-renal clearances decreased by 67 %, 77 % and 50 %, respectively, in subjects with severe renal failure, but there was no reduction in tolerability associated with the increase in exposure.
Po intravenskem dajanju 0,5 mg ibandronske kisline se je pri bolnikih s hudo motnjo ledvičnega delovanja celokupni očistek zmanjšal za 67 %, ledvični očistek za 77 %, neledvični očistek pa za 50 %.
• pain in your muscles, joints, or back
• bolečina v mišicah sklepih ali hrbtu,
radiotherapy to bone for treatment of fractures/impending fractures surgery to bone for treatment of fractures vertebral fractures non-vertebral fractures.
zdravljenje kosti z obsevanjem zaradi fraktur/pretečih fraktur, operacija kosti za zdravljenje fraktur, vertebralne frakture,
Table 4: Results from 3 years fracture study MF 4411 (%, 95 % CI) for patients with lumbar spine BMD T-score below -2.5 at baseline
Preglednica 4: Rezultati 3-letne študije zlomov MF 4411 (%, 95-% interval zaupanja) za bolnike, ki so imeli na začetku zdravljenja T-vrednost MKG ledvene hrbtenice pod -2,5.
Based on the results of study BM 16550, ibandronic acid 3 mg intravenous injection, administered every 3 months is expected to be at least as effective in preventing fractures as the oral regimen of ibandronic acid 2.5 mg daily.
Glede na rezultate študije BM 16550 pričakujemo, da je ibandronska kislina 3 mg v obliki intravenske injekcije, ki jo dajemo vsake 3 mesece, najmanj enako učinkovita v preprečevanju zlomov kakor peroralno odmerjena ibandronska kislina 2,5 mg enkrat na dan.
Due to limited clinical experience, ibandronic acid injection is not recommended for patients with a serum creatinine above 200 μmol/l (2.3 mg/dl) or with a creatinine clearance below 30 ml/min (see section 4.2 and section 5.2).
Zaradi omejenih kliničnih izkušenj ibandronske kisline v obliki injekcije ne priporočamo bolnikom, ki imajo serumski kreatinin nad 200 µmol/l (2,3 mg/dl) ali kreatininski očistek, manjši kot 30 ml/min (glejte poglavje 4.2 in poglavje 5.2).
Secondary efficacy endpoints
Sekundarni cilj raziskave učinkovitosti
Daily oral treatment with ibandronic acid 2.5 mg tablets resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Peroralno zdravljenje z 2,5-mg tabletami ibandronske kisline enkrat na dan je povzročilo progresivno povišanje MKG vretenc in nevretenčnih delov skeleta.
Ibandronic acid Accord 2 mg and 6 mg concentrate for solution for infusion (for oncology indications)
Ibandronska kislina Accord 2 mg in 6 mg koncentrat za raztopino za infundiranje (za onkološke indikacije)
Studies in rats have shown some reproductive toxicity (see section 5.3).
Študije na podganah so pokazale določen vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of ibandronic acid 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
V ključni dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16550) je bila celokupna varnost ibandronske kisline 3 mg v obliki intravenske injekcije, dane vsake 3 mesece, in ibandronske kisline 2,5 mg, dane peroralno enkrat na dan, podobna.
Solution for injection 1 pre-filled syringe + 1 injection needle 4 pre-filled syringes + 4 injection needles
1 napolnjena injekcijska brizga + 1 injekcijska igla 4 napolnjene injekcijske brizge + 4 injekcijske igle
Independent risk factors, for example, low BMD, age, the existence of previous fractures, a family history of fractures, high bone turnover and low body mass index should be considered in order to identify women at increased risk of osteoporotic fractures.
Pri prepoznavanju žensk s povečanim tveganjem za osteoporotični zlom moramo upoštevati neodvisne dejavnike tveganja, kot so na primer nizka mineralna kostna gostota, starost, obstoj predhodnih zlomov, družinska obremenjenost z zlomi, visoko razmerje med razgradnjo in tvorbo kosti in nizek indeks telesne mase.
Prior to treatment with Ibandronic acid Accord the patient should be adequately rehydrated with 9 mg/ml (0.9 %) sodium chloride.
Pred začetkom zdravljenja z zdravilom Ibandronska kislina Accord je potrebna zadostna rehidracija bolnika z natrijevim kloridom 9 mg/ml (0,9 %).
Plasma concentrations of ibandronic acid increase in a dose-proportional manner after intravenous administration of 0.5 mg to 6 mg.
Plazemske koncentracije ibandronske kisline se po intravenskem dajanju 0,5 mg do 6 mg povečujejo sorazmerno z odmerkom.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 6 mg/6 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 6 mg/6 ml
There is no evidence that ibandronic acid is metabolised in animals or humans.
Ni dokazov, da bi se ibandronska kislina pri ljudeh in živalih presnavljala.
Hypocalcaemia and other disturbances of bone and mineral metabolism should be assessed and effectively treated before starting Ibandronic acid Accord injection therapy.
Hipokalcemijo in druge motnje v kosteh in presnovi mineralov moramo prepoznati in učinkovito zdraviti pred začetkom intravenskega zdravljenja z zdravilom Ibandronska kislina Accord.
Early plasma levels fall quickly, reaching 10 % of the 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 in 8 ur po peroralnem dajanju.
What you need to know before you receive Ibandronic acid Accord 3.
Kaj morate vedeti, preden boste prejeli zdravilo Ibandronska kislina Accord 3.
Do not use this medicine after the expiry date which is stated on the carton and on the label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
INFORMATION IN BRAILLE [Justification for not including Braille accepted]
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
Ibandronic acid is only for use in postmenopausal women and must not be taken by women of child bearing potential.
Ibandronsko kislino lahko uporabljajo samo ženske v postmenopavzi, ženske v rodni dobi pa ga ne smejo uporabljati.
After that, go back to getting the injections every 3 months from the date of the most recent injection.
Po tem se vrnite na običajno shemo odmerjanja, ki je vsake 3 mesece od dneva zadnje injekcije.
• hair loss
• izguba las;
Most cases of adverse reactions did not lead to cessation of therapy.
V večini primerov prekinitev terapije zaradi neželenih učinkov ni bila potrebna.
Any unused solution for injection, syringe and injection needle should be disposed of in accordance with local requirements.
Neuporabljeno raztopino za injekcije, injekcijske brizge in injekcijske igle zavrzite v skladu z lokalnimi predpisi.
Each ml of solution contains 1 mg ibandronic acid.
En ml raztopine vsebuje 1 mg ibandronske kisline.
Excipients with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially sodium free.
Pomožne snovi z znanim učinkom Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni brez natrija.
See section 4.
Preglednica 3.
• pain or sore in your mouth or jaw.
• bolečina ali rana v vaših ustih ali čeljusti.
Gastritis, Dyspepsia, Diarrhoea, Abdominal pain, Nausea, Constipation
Bolezni prebavil gastritis, dispepsija, diareja, abdominalna bolečina, navzea, zaprtje
What you need to know before you receive Ibandronic acid Accord
Kaj morate vedeti, preden boste prejeli zdravilo Ibandronska kislina Accord
• inflammation of a vein
• vnetje vene,
Ibandronic acid concentrate for solution for infusion should be administered as an intravenous infusion over 2 hours.
Koncentrat ibandronske kisline za raztopino za infundiranje je treba aplicirati v obliki intravenske infuzije 2 uri.
Ibandronic acid Accord may help lower the chances of breaking bones (fractures).
Zdravilo Ibandronska kislina Accord pomaga zmanjšati možnost zloma.
There is no evidence for any clinically relevant inter-ethnic differences between Asians and Caucasians in ibandronic acid disposition.
Za klinično pomembne medetnične razlike v razpoložljivosti ibandronske kisline med Azijci in Kavkazijci ni dokazov.
• not enough calcium and vitamin D in the diet
• premajhen vnos kalcija in vitamina D s hrano,
• walking or other weight-bearing exercise
• hojo ali druge telesne aktivnosti z vplivom na telesno maso,
The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 1530 seconds, every three months.
Priporočeni odmerek ibandronske kisline je 3 mg v obliki intravenske injekcije, ki jo dajemo 15 do 30 sekund, vsake 3 mesece.
Clinical studies in the prevention of skeletal events in patients with breast cancer and bone metastases
Klinične študije preprečevanja z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh
For the prevention of skeletal events in patients with breast cancer and bone metastases, the Ibandronic acid Accord infusion is repeated at 3-4 week intervals.
Za preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh infuzijo zdravila Ibandronska kislina Accord ponovimo v 3- do 4-tedenskih intervalih.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Hypocalcaemia
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
This is because aminoglycosides and Ibandronic acid Accord can both lower the amount of calcium in your blood.
Aminoglikozidi in zdravilo Ibandronska kislina Accord lahko znižajo koncentracijo kalcija v krvi.
2 mg 4 mg 6 mg For these patients and dosages, the median time to achieve normocalcaemia was 4 to 7 days.
Za te bolnike je bila pri teh odmerkih mediana časa do normokalciemije 4 do 7 dni.
Prior to treatment with ibandronic acid the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride solution.
Pred zdravljenjem z ibandronsko kislino izvedemo ustrezno hidracijo bolnika z raztopino natrijevega klorida 9 mg/ml (0,9 %).
Overhydration should be avoided in patients at risk of cardiac failure.
Pri bolnikih, pri katerih obstaja tveganje za srčno popuščanje, se je treba izogibati pretirani hidraciji.
Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Rezultati učinkovitosti (bolniki z rakom dojke in metastatično boleznijo kosti)
Paediatric population (see section 4.2 and section 5.1)
Pediatrična populacija (glejte poglavji 4.2 in 5.1)
6 ml, glass vial (type I) with ethylene tetrafluoroethylene rubber stopper and aluminium seals with pink flip-off cap.
6 ml viala iz stekla (tipa I) z etilen tetrafluoroetilenskim gumijastim zamaškom in aluminijastim pokrovčkom s »flip-off« zaporko v roza barvi.
After dilution:
Po razredčitvi:
Where the medicinal product is administered into an existing intravenous infusion line, the infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.
Kadar se zdravilo daje v obstoječe intravenske infuzijske kanale, je infuzat lahko le izotonična raztopina natrijevega klorida ali 50 mg/ml (5-%) raztopina glukoze.
Each pre-filled syringe contains 3 ml of solution.
Ena napolnjena injekcijska brizga vsebuje 3 ml raztopine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Ibandronska kislina Accord Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Ibandronic acid injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients (see section 4.4 and section 5.2)
Uporaba ibandronske kisline v obliki injekcije pri bolnikih s serumskim kreatininom nad 200 µmol/l (2,3 mg/dl) ali s kreatininskim očistkom (izmerjenim ali ocenjenim) pod 30 ml/min zaradi malo kliničnih podatkov iz študij, ki so vključevale take bolnike, ni priporočljiva (glejte poglavji 4.4 in 5.2).
Ibandronic acid 2.5 mg daily tablets
Ibandronska kislina, 2,5-mg tableta, enkrat na dan
Care must be taken not to administer ibandronic acid injection via intra-arterial or paravenous administration as this could lead to tissue damage.
Potrebna je previdnost, da injekcije ibandronske kisline ne damo intraarterijsko ali paravensko, ker lahko poškodujemo tkivo.
Elderly population (see section 4.2)
Starejši bolniki (glejte poglavje 4.2)
Ibandronic acid Accord 3 mg solutionfor injection (for osteoporosos indications) Medicinal product subject to medical prescription.
Ibandronska kislina Accord 3 mg raztopina za injiciranje (za indikacije, povezane z osteoporozo) Predpisovanje in izdaja zdravila je le na recept.
(dead bone tissue) in the jaw bone).
(nekrozo (mrtvo kostno tkivo) v čeljustnicah);
Ibandronic acid solution for injection must not be mixed with calcium-containing solutions or other intravenously administered medicinal products.
Raztopine ibandronske kisline za injiciranje ne smemo mešati z raztopinami, ki vsebujejo kalcij, ali drugimi intravensko dajanimi zdravili.
Excipient with known effect Ibandronic acid injection is essentially sodium free.
Pomožna snov z znanim učinkom Zdravilo Ibandronska kislina Accord je praktično brez natrija.
The pharmacokinetics of ibandronic acid in patients with end-stage renal disease was only assessed in a small number of patients managed by haemodialysis, therefore, the pharmacokinetics of ibandronic acid in the patients not undergoing haemodialysis is unknown.
Farmakokinetiko ibandronske kisline pri bolnikih s končno ledvično odpovedjo so proučevali le pri majhnem številu bolnikov, ki so se zdravili s hemodializo.
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Ibandronska kislina Accord Obvestite zdravnika, medicinsko sestro ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with ibandronic acid in patients with concomitant risk factors.
Pri bolnikih s sočasnimi dejavniki tveganja je priporočljivo, da se pred začetkom zdravljenja z ibandronsko kislino opravita zobozdravstveni pregled in individualna ocena koristi in tveganja.
Where Ibandronic acid Accord is administered via an existing intravenous infusion line, the intravenous infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.
Kjer zdravilo Ibandronska kislina Accord dajemo skozi obstoječi intravenski infuzijski kanal, je intravenski infuzat lahko le izotonična raztopina natrijevega klorida ali 50 mg/ml (5-%) raztopina glukoze.
• fluid in your lungs
• nabiranje tekočine v pljučih;
Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Ibandronska kislina Accord 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi lahko kot drugi intravensko dajani difosfonati povzroči prehodno zmanjšanje koncentracije kalcija v serumu.
Packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
Na voljo je pakiranje po 1 napolnjeno injekcijsko brizgo in 1 injekcijsko iglo ali po 4 napolnjene injekcijske brizge in 4 injekcijske igle.
For treatment of tumour induced hypercalcaemia, Ibandronic acid Accord concentrate for solution for infusion is generally given as a single infusion.
Za zdravljenje tumorsko povzročene hiperkalciemije običajno dajemo koncentrat za raztopino za infundiranje Ibandronska kislina Accord kot enkratno infuzijo.
• kidney cyst(fluid-filled sac in the kidney)
• ledvična cista (vrečka v ledvicah napolnjena s tekočino).
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni "brez natrija".
Your doctor will work out how much Ibandronic acid Accord you will be given depending on your illness.
Glede na vašo bolezen bo vaš zdravnik določil, kolikšen odmerek zdravila Ibandronska kislina Accord boste prejeli.
Reproductive toxicity:
Vpliv na sposobnost razmnoževanja:
Ibandronic acid Accord contains the active substance ibandronic acid.
Zdravilo Ibandronska kislina Accord vsebuje zdravilno učinkovino ibandronsko kislino.
Strict adherence to the intravenous administration route is required (see section 4.4).
Zdravilo moramo dajati izključno intravensko (glejte poglavje 4.4).
The proportion of patients who increased or maintained their BMD at one year at both lumbar spine and total hip was 76.2 % in the 3 mg injection every 3 months arm and 67.2 % in the 2.5 mg daily orally arm (p=0.007).
Delež bolnikov, ki se jim je MKG lumbalne hrbtenice in kolka povišala ali ostala enaka izhodiščni vrednosti po enem letu je bil 76,2 % v skupini, ki je prejemala 3-mg injekcijo vsake 3 mesece, in 67,2 % v skupini, ki je prejemala 2,5 mg na dan peroralno (p = 0,007).
You can drive and use machines as it's expected that Ibandronic acid Accord has no or negligible effect on your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Lahko vozite in upravljate s stroji, saj pričakujemo, da zdravilo Ibandronska kislina Accord nima vpliva ali pa ima zanemarljiv vpliv na vašo sposobnost vožnje in upravljanja s stroji.
What Ibandronic Acid Accord is and what it is used for
Kaj je zdravilo Ibandronska kislina Accord in za kaj ga uporabljamo
PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra, brezbarvna raztopina
Talk to your doctor first if you want to drive, use machines or tools.
Če želite voziti ali upravljati s stroji, se prej posvetujte z zdravnikom.
6 ml, glass vial (type I) with ethylene tetrafluoroethylene rubber stopper and aluminium seals with lavender flip-off cap.
6 ml viala iz stekla (tipa I) z etilen tetrafluoroetilenskim gumijastim zamaškom in aluminijastim pokrovčkom s »flip-off« zaporko v barvi sivke.
EXP: Read the package leaflet for the shelf life after dilution.
EXP: Za rok uporabnosti zdravila po razredčitvi glejte navodilo za uporabo.
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev), odgovornega za sproščanje serij Accord Healthcare Ltd.
Incidence of new morphometric vertebral fractures
Incidenca novih zlomov vretenc (določeno morfometrično)
Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
osteonekroza čeljustnic†** osteonekroza zunanjega slušnega kanala (neželeni učinek na difosfonate)†
5 vials (6 mg/6 ml) 10 vials (6 mg/6 ml)
5 vial (6 mg/6 ml)
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 za 2 mg in 4 mg odmerke.
There is no relevant use of ibandronic acid in children below 18 years, and ibandronic acid was not studied in this population (see section 5.1 and 5.2).
Ibandronske kisline pri tej populaciji bolnikov niso proučevali (glejte poglavji 5.1 in 5.2).
Administration of Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Ibandronska kislina Accord 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi se daje intravensko 15 do 30 sekund.
• Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours.
• zdravljenje tumorsko povzročene hiperkalciemije − dodamo k 500 ml izotonične raztopine natrijevega klorida ali k 500 ml 5-% raztopine dekstroze in infundiramo 2 uri.
Pyrexia,Influenz a-like illness**, oedema peripheral, asthenia, thirst
Splošne težave in spremembe na mestu aplikacije pireksija, gripi podobna bolezen**, periferni edem, astenija, žeja hipotermija
Children and adolescents Ibandronic acid Accord must not be used in children or adolescents below 18 years.
Zdravila Ibandronska kislina Accord se ne sme uporabljati pri otrocih ali mladostnikih, mlajših od 18 let.
Overdose No specific information is available on the treatment of overdosage with Ibandronic acid Accord.
Specifičnih informacij o zdravljenju prevelikega odmerjanja zdravila Ibandronska kislina Accord ni na voljo.
If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Patients treated with ibandronic acid should be given the package leaflet and the patient reminder card. Posology
Bolniki, ki se zdravijo z ibandronsko kislino, morajo dobiti navodilo za uporabo in opozorilno kartico za bolnika.
If you are not sure, talk to your doctor or pharmacist before having Ibandronic acid Accord.
Če ste negotovi, se, preden boste prejeli zdravilo Ibandronska kislina Accord, posvetujte z zdravnikom ali farmacevtom.
No specific information is available on the treatment of overdosage with ibandronic acid injection.
Specifičnih informacij o zdravljenju prevelikega odmerjanja ibandronske kisline ni na voljo.
Care must be taken not to administer ibandronic acid concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Paziti je treba, da koncentrata za raztopino za infundiranje zdravila Ibandronska kislina Accord ne dajemo intraarterijsko ali paravensko, ker lahko to vodi v poškodbo tkiva.
In order to avoid potential incompatibilities, Ibandronic acid Accord concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution.
Da se izognemo možnim nezdružljivostim, lahko koncentrat za raztopino za infundiranje Ibandronska kislina Accord razredčimo le z izotonično raztopino natrijevega klorida ali 5 % raztopino glukoze.
The primary analysis of data from study BM16550 at one year and the confirmatory analysis at 2 years demonstrated the non-inferiority of 3 mg every 3 months injection dosing regimen compared to 2.5 mg oral daily dosing regimen, in terms of mean increases in BMD at lumbar spine, total hip, femoral neck and trochanter (Table 2).
Primarna analiza podatkov iz študije BM 16550 po enem letu in potrditvena analiza po dveh letih sta pokazali, da v povprečnem zvišanju MKG ledvene hrbtenice, kolka, stegneničnega vratu in trohantra 3-mg injekcija, dana vsake 3 mesece ni manj učinkovita kot 2,5 mg peroralno na dan (preglednica 2).
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg is an adequate single dose.
Pri večini bolnikov s hudo hiperkalciemijo (korigirani kalcij v serumu *  3 mmol/l ali  12 mg/dl) zadošča enkratni odmerek 4 mg.