natgillin/translations-raw huggingface dataset:
These side effects may occur with certain frequencies, which are defined as follows:  very common: affects more than 1 patient in 10  common: affects 1 to 10 patients in 100  uncommon: affects 1 to 10 patients in 1,000  rare: affects 1 to 10 patients in 10,000 49  very rare: affects less than 1 patient in 10,000  not known: frequency cannot be estimated from the available data.
49 Ti neželeni učinki se lahko pojavljajo z določenimi pogostnostmi, ki so opredeljene takole:  zelo pogosti: prizadenejo več kot 1 bolnika od 10,  pogosti: prizadenejo 1 do 10 bolnikov od 100,  občasni: prizadenejo 1 do 10 bolnikov od 1. 000,  redki: prizadenejo 1 do 10 bolnikov od 10. 000,  zelo redki: prizadenejo manj kot 1 bolnika od 10. 000,  neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Some symptoms need immediate medical attention You should stop taking Zomarist and see your doctor immediately if you experience the following side effects:
Pri nekaterih simptomih je potrebna takojšnja zdravniška pomoč V primeru, da pride do naslednjih neželenih učinkov, morate prenehati jemati zdravilo Zomarist in takoj obiskati zdravnika:
- decreased vitamin B12 levels (paleness, tiredness, mental symptoms such as confusion or
znižane vrednosti vitamina B 12 (bledica, utrujenost, psihični simptomi, kot sta zmedenost ali
HOW TO STORE ZOMARIST
SHRANJEVANJE ZDRAVILA ZOMARIST
The expiry
- Zdravila Zomarist ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na
What Zomarist contains 50
Kaj vsebuje zdravilo Zomarist
- Each Zomarist 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg
- Vsaka filmsko obložena tableta Zomarist 50 mg/ 850 mg vsebuje 50 mg vildagliptina in 850 mg
- Each Zomarist 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg
- Vsaka filmsko obložena tableta Zomarist 50 mg/ 1000 mg vsebuje 50 mg vildagliptina in
What Zomarist looks like and contents of the pack Zomar ist 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Izgled zdravila Zomarist in vsebina pakiranja Zomarist 50 mg/ 850 mg filmsko obložene tablete so rumene, ovalne tablete z oznako “ NVR ” na eni strani in “ SEH ” na drugi.
Zomarist 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Zomarist 50 mg/ 1000 mg filmsko obložene tablete so temno rumene, ovalne tablete z oznako “ NVR ” na eni strani in “ FLO ” na drugi.
It is available as a powder and solvent, and as a concentrate, which are made up into a solution for infusion (drip into a vein).
Na voljo je kot prašek in vehikel oz. kot koncentrat za pripravo raztopine za infundiranje (dajanje v veno).
Zometa can be used to prevent bone complications in patients with advanced cancer that is affecting the bone.
Zdravilo Zometa se lahko uporablja za preprečevanje zapletov, povezanih z okostjem, pri bolnikih z napredovalim rakom, ki zajame kosti.
This includes fractures, spinal compression, bone disorders needing radiotherapy or surgery, and hypercalcaemia (high levels of calcium in the blood).
Ti zapleti vključujejo zlome kosti, spinalno kompresijo, kostne zaplete, ki terjajo obsevanje ali operacijo, ter hiperkalciemijo (visoko raven kalcija v krvi).
Zometa must only be used by a doctor who has experience in the use of this type of intravenous medicine.
Zdravilo Zometa smejo uporabljati le zdravniki z izkušnjami z uporabo te vrste zdravil za intravensko uporabo.
The usual dose of Zometa is one infusion of 4 mg over at least 15 minutes.
Običajni odmerek zdravila Zometa je ena 4 mg infuzija v trajanju najmanj 15 minut.
When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D.
Pri uporabi za preprečevanje zapletov, povezanih z okostjem, je infuzijo mogoče ponoviti vsake tri do štiri tedne, bolniki pa morajo prejemati tudi dodatek kalcija in vitamina D.
A lower dose is recommended for patients with bone metastases (cancer that has spread to the bone) if they have mild to moderate problems with their kidneys.
Pri bolnikih s kostnimi metastazami (raku, ki se je razširil na kost), ki imajo blage do zmerne težave z ledvicami, je priporočljiv manjši odmerek zdravila.
The reduction of bone loss helps to make bones less likely to break, and this is useful in preventing fractures in cancer patients with bone metastases.
Zahvaljujoč zmanjšanju izgube kostne mase je manj verjetno, da se bodo kosti zlomile, to pa je koristno pri preprečevanju zlomov pri rakavih bolnikih s kostnimi metastazami.
Patients with tumours can have high level of calcium in their blood, released from the bones.
Bolniki s tumorji utegnejo imeti v krvi visoke koncentracije kalcija, ki se sprosti iz kosti.
By preventing the breakdown of bones, zoledronic acid helps to reduce the levels of calcium released in the blood.
S preprečevanjem razgradnje kosti zoledronska kislina prispeva k zmanjšanju količine kalcija, sproščenega v kri.
Zometa has been studied in over 3,000 patients with bone metastases to look at its effectiveness in the prevention of bone damage.
Zdravilo Zometa so preučevali pri več kot 3. 000 bolnikih s kostnimi metastazami, da bi tako raziskali njegovo učinkovitost pri preprečevanju poškodb kosti.
Zometa was compared with placebo (a dummy treatment) in two studies, and with pamidronate (another bisphosphonate) in the third study.
Zdravilo Zometa so v dveh študijah primerjali s placebom, v tretji pa s pamidronatom (drugim difosfonatom).
The main measure of effectiveness 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Glavno merilo učinkovitosti je bil delež 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. was the proportion of patients who developed at least one new ‘ skeletal event ’ over 13 months.
Reproduction is authorised provided the source is acknowledged. bolnikov, pri katerih se je v teku 13 mesecev razvil vsaj en nov dogodek, povezan z okostjem.
This included any bone complication needing to be treated either with radiotherapy or surgery, any fractures or any occurrence of spinal compression.
Taki dogodki so vključevali vsakršne kostne zaplete, ki so terjali bodisi obsevanje ali operacijo, morebitne zlome ali pojav spinalne kompresije.
The effectiveness of Zometa in patients with hypercalcaemia caused by tumours has been studied in two main studies involving a total of 287 patients.
Učinkovitost zdravila Zometa pri bolnikih s hiperkalciemijo, pogojeno s tumorji, so preučevali v dveh glavnih študijah, v kateri je bilo vključenih skupno 287 bolnikov.
Zometa was compared with pamidronate.
Zdravilo Zometa so primerjali s pamidronatom.
The main measure of effectiveness was the proportion of patients whose calcium levels had returned to normal within 10 days after treatment.
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih se je raven kalcija v 10 dneh po zdravljenju vrnila v normalno območje.
In patients with bone metastases, the proportion of patients who developed a new skeletal event was lower with Zometa (33 to 38%) than with placebo (44%).
Pri bolnikih s kostnimi metastazami, ki so prejemali zdravilo Zometa, je bil delež bolnikov, pri katerih se je razvil nov, z okostjem povezan dogodek nižji kot pri tistih, ki so prejemali placebo (33 do 38% v primerjavi s 44%).
Zometa was also as effective as pamidronate: the proportion of patients with one event was 44% with Zometa and 46% with pamidronate.
Zdravilo Zometa je bilo tudi enako učinkovito kot pamidronat: delež bolnikov z enim dogodkom je bil pri zdravilu Zometa 44%, pri pamidronatu pa 46%.
Looking at the results of the two studies together, the proportion of patients whose calcium levels were normal within 10 days after treatment was 88% with Zometa compared with 70% for pamidronate.
Če pogledamo rezultate obeh študij skupaj, ugotovimo, da je delež bolnikov, pri katerih je bila koncentracija kalcija v 10 dneh po zdravljenju normalna, pri zdravilu Zometa znašal 88%, pri pamidronatu pa 70%.
The most common side effect with Zometa (seen in more than 1 patient in 10) is hypophosphataemia (low blood phosphate levels).
Najpogostejši neželeni učinek zdravila Zometa (opažen pri več kot 1 bolniku izmed 10) je hipofosfatemija (nizka koncentracija fosfatov v krvi).
For the full list of all side effects reported with Zometa, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zometa, glejte navodilo za uporabo.
Zometa should not be used in people who may be hypersensitive (allergic) to zoledronic acid, to other bisphosphonates or to any of the other ingredients.
Zdravila Zometa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zoledronsko kislino, na druge difosfonate ali katero koli drugo sestavino zdravila.
Zometa should not be used in pregnant or breast- feeding women.
Zdravila Zometa ne smejo uporabljati nosečnice in doječe ženske.
As with all bisphosphonates, patients taking Zometa may be at risk of osteonecrosis (death of bone tissue) in the jaw.
Tako kot pri uporabi vseh difosfonatov obstaja pri bolnikih, ki jemljejo zdravilo Zometa, tveganje za osteonekrozo (odmiranje kostnega tkiva) čeljusti.
The Committee for Medicinal Products for Human Use (CHMP) decided that Zometa’ s benefits are greater than its risks for the prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone, and for the treatment of tumour-induced hypercalcaemia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Zometa pri preprečevanju z okostjem povezanih dogodkov (patoloških zlomov, spinalne kompresije, obsevanj oz. operacij kosti ali tumorsko povzročene hiperkalciemije) pri bolnikih z napredovalimi malignimi obolenji, ki zajamajo kosti, ter pri zdravljenju tumorsko povzročene hiperkalciemije večje od z njim povezanih tveganj.
The Committee recommended that Zometa be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Zometa odobri dovoljenje za promet.
Other information about Zometa:
Druge informacije o zdravilu Zometa:
The European Commission granted a marketing authorisation valid throughout the European Union to Novartis Europharm Limited for Zometa on 20 March 2001.
Evropska komisija je dovoljenje za promet z zdravilom Zometa, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 20. marca 2001.
The marketing authorisation was renewed on 20 March 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 20. marca 2006.
The full EPAR for Zometa is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zometa je na voljo tukaj.
4 mg; solvent:
4 mg; vehikel:
One vial contains 4 mg zoledronic acid (anhydrous), corresponding to 4.264 mg zoledronic acid monohydrate.
Ena viala vsebuje 4 mg zoledronske kisline (brezvodne), kar ustreza 4, 264 mg zoledronske kisline monohidrat.
- Prevention of skeletal related events (pathological fractures, spinal compression, radiation or
- Preprečevanje z okostjem povezanih dogodkov (patološki zlomi, spinalna kompresija,
surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone.
obsevanje ali operacija kosti ali tumorsko povzročena hiperkalciemija) pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti.
- Treatment of tumour-induced hypercalcaemia (TIH).
- Zdravljenje tumorsko povzročene hiperkalciemije (TIH).
Zometa must only be used by clinicians experienced in the administration of intravenous bisphosphonates.
Zometo smejo uporabljati samo zdravniki kliniki, ki imajo izkušnje z uporabo difosfonatov za intravensko uporabo.
Zometa reconstituted solution must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer’ s solution, and should be administered as a single intravenous solution in a separate infusion line.
Rekonstituirane raztopine zdravila Zometa se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jo je treba aplicirati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
Prevention of skeletal related events in patients with advanced malignancies involving bone Adults and elderly The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg reconstituted and further diluted Zometa solution for infusion (diluted with 100 ml 0.9% w/ v sodium chloride or 5% w/ v glucose solution), given in no less than a 15-minute intravenous infusion every 3 to 4 weeks.
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti Odrasli in starejši bolniki Priporočeni odmerek za preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti, je 4 mg rekonstituirane in dodatno razredčene raztopine Zomete za intravensko infundiranje (razredčene s 100 ml 0, 9 -% m/ v raztopine natrijevega klorida ali 5 -% m/ v raztopine glukoze), dane v obliki intravenske infuzije, ki teče vsaj 15 minut, vsake 3 do 4 tedne.
Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
Bolniki morajo prejeti tudi peroralni dodatek 500 mg kalcija in 400 i. e. vitamina D na dan.
Treatment of TIH Adults and elderly The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/ dl or 3.0 mmol/ l) is 4 mg reconstituted and further diluted Zometa solution for infusion (diluted with 100 ml sterile 0.9% w/ v sodium chloride or 5% w/ v glucose solution), given as a single intravenous infusion in no less than 15 minutes.
Zdravljenje tumorsko povzročene hiperkalciemije (TIH) Odrasli in starejši bolniki Priporočeni odmerek za hiperkalciemijo (za albumin korigirani serumski kalcij ≥ 12, 0 mg/ dl ali 3, 0 mmol/ l) je 4 mg rekonstituirane in dodatno razredčene raztopine Zomete za intravensko infundiranje (razredčene s 100 ml sterilne 0, 9- odstotne m/ v raztopine natrijevega klorida ali 5- odstotne m/ v raztopine glukoze), dane v obliki ene same intravenske infuzije, ki naj teče vsaj 15 minut.
Patients must be maintained well hydrated prior to and following administration of Zometa.
Bolniki morajo biti pred in po dajanju Zomete dobro hidrirani.
2 Renal impairment TIH:
2 Ledvične okvare Tumorsko povzročena hiperkalciemija (TIH):
Zometa treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Zdravljenje z Zometo pri bolnikih s TIH, ki imajo tudi težko ledvično okvaro, lahko pride v poštev šele po oceni nevarnosti in koristnih učinkov zdravljenja.
In the clinical studies, patients with serum creatinine > 400 µmol/ l or > 4.5 mg/ dl were excluded.
Bolnike s serumskim kreatininom > 400 µmol/ l ali > 4, 5 mg/ dl so izključili iz kliničnih študij.
No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/ l or < 4.5 mg/ dl (see section 4.4).
Pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH), s serumskim kreatininom < 400 µmol/ l ali < 4, 5 mg/ dl, ni potrebno prilagajanje odmerjanja (glejte poglavje 4. 4).
When initiating treatment with Zometa in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CrCl) should be determined.
Pri uvajanju zdravljenja z Zometo pri bolnikih z multiplim mielomom ali metastatičnimi kostnimi lezijami zaradi čvrstih tumorjev je treba določiti serumski kreatinin in očistek kreatinina (CrCl).
CrCl is calculated from serum creatinine using the Cockcroft-Gault formula.
CrCl se izračuna iz serumskega kreatinina s Cockcroft- Gaultovo formulo.
Zometa is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CrCl < 30 ml/ min.
Zomete ne priporočajo bolnikom, ki imajo že pred uvedbo zdravljenja težko ledvično okvaro, ki je za to skupino bolnikov opredeljena kot CrCl < 30 ml/ min.
In clinical trials with Zometa, patients with serum creatinine > 265 µmol/ l or > 3.0 mg/ dl were excluded.
Bolniki s serumskim kreatininom > 265 µmol/ l ali > 3, 0 mg/ dl so bili iz kliničnih preskušanj z Zometo izključeni.
In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CrCl 30– 60 ml/ min, the following Zometa dose is recommended (see also section 4.4):
Pri bolnikih z zasevki v kosteh, ki imajo pred začetkom zdravljenja blago do zmerno okvaro ledvic (opredeljeno za to skupino bolnikov kot CrCl 30– 60 ml/ min), priporočajo naslednji odmerek Zomete (glejte tudi poglavje 4. 4):
Clearance (ml/ min) > 60
Izhodiščni očistek kreatinina (ml/ min) > 60
Zometa Recommended Dose* 4.0 mg
odmerek Zomete * 4, 0 mg
*Doses have been calculated assuming target AUC of 0.66 (mg• hr/ l) (CrCl=75 ml/ min).
* Odmerke so izračunali tako, da so predpostavili tarčno AUC 0, 66 (mg• hr/ l) (CrCl=75 ml/ min).
The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/ min.
Pričakuje se, da bodo zmanjšani odmerki pri bolnikih z ledvičnimi okvarami dosegli iste AUC, kot jih vidimo pri bolnikih z očistkom kreatinina 75 ml/ min.
Following initiation of therapy, serum creatinine should be measured prior to each dose of Zometa and treatment should be withheld if renal function has deteriorated.
Po uvedbi terapije je treba izmeriti serumski kreatinin pred vsakim odmerkom Zomete, terapijo pa je treba prekiniti, če se je ledvična funkcija poslabšala.
- For patients with normal baseline serum creatinine (< 1.4 mg/ dl or < 124 µmol/ l), an increase of
- pri bolnikih z normalnim izhodiščnim serumskim kreatininom (< 1, 4 mg/ dl ali < 124µmol/ l),
0.5 mg/ dl or 44 µmol/ l;
zvišanje za 0, 5 mg/ dl ali 44 µmol/ l;
- For patients with an abnormal baseline creatinine (> 1.4 mg/ dl or > 124 µmol/ l), an increase of
- pri bolnikih s patološkim izhodiščnim kreatininom (> 1, 4 mg/ dl ali > 124 µmol/ l), zvišanje za
1.0 mg/ dl or 88 µmol/ l.
1, 0 mg/ dl ali 88 µmol/ l.
In the clinical studies, Zometa treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
V kliničnih študijah so nadaljevali z zdravljenjem z Zometo šele, ko se je koncentracija kreatinina vrnila na raven, ne za več kot 10% višjo od izhodiščne vrednosti (glejte poglavje 4. 4).
Zometa treatment should be resumed at the same dose as that prior to treatment interruption.
Zdravljenje z Zometo je treba spet začeti z enakim odmerkom kot pred prekinitvijo zdravljenja.
Instructions for preparing reduced doses of Zometa Withdraw an appropriate volume of the reconstituted solution (4 mg/ 5 ml) as needed:
Navodila za pripravo zmanjšanih odmerkov Zomete Odvzemite ustrezni volumen rekonstituirane raztopine (4 mg/ 5 ml), kot sledi:
- 4.4 ml for 3.5 mg dose
- 4, 4 ml za odmerek 3, 5 mg
- 4.1 ml for 3.3 mg dose
- 4, 1 ml za odmerek 3, 3 mg
- 3.8 ml for 3.0 mg dose
- 3, 8 ml za odmerek 3, 0 mg
For information on the reconstitution and dilution of Zometa, see section 6.6.
Za podatke o rekonstituciji in razredčevanju Zomete glejte poglavje 6. 6.
The withdrawn amount of reconstituted solution must be diluted in 100 ml of sterile 0.9% w/ v sodium chloride solution or 5% w/ v glucose solution.
Odvzeto količino rekonstituirane raztopine morate razredčiti v 100 ml sterilne 0, 9- odstotne m/ v raztopine natrijevega klorida ali 5- odstotne m/ v raztopine glukoze.
The use of Zometa in paediatric patients has not been studied.
Uporabe Zomete pri otrocih in mladostnikih niso raziskovali.
Zometa should not be used in that patient population until further data becomes available.
Pri tej skupini bolnikov Zomete ne smete uporabljati, dokler ne bo na voljo več podatkov.
Zometa powder for solution for infusion is contraindicated in breast-feeding women and in patients with clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any of the excipients in the formulation of Zometa.
Prašek za raztopino za infundiranje Zometa je kontraindiciran pri doječih ženskah in pri bolnikih s klinično pomembno preobčutljivostjo za zoledronsko kislino, za druge difosfonate ali za katero od pomožnih snovi v sestavi Zomete.
General Patients must be assessed prior to administration of Zometa to ensure that they are adequately hydrated.
Splošno Pred uporabo Zomete moramo bolnike oceniti, da zagotovimo, da so ustrezno hidrirani.
Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zometa therapy.
Po začetku zdravljenja z Zometo moramo skrbno spremljati standardne presnovne parametre, povezane s hiperkalciemijo, kot so: serumske koncentracije kalcija, fosfata in magnezija.
The safety and efficacy of Zometa in paediatric patients have not been established.
Varnosti in učinkovitosti Zomete pri pediatričnih bolnikih niso ugotavljali.
Renal insufficiency Patients with TIH with evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zometa outweighs the possible risk.
Ledvična insuficienca Bolnike s tumorsko povzročeno hiperkalciemijo (TIH), ki kažejo znake poslabšanja ledvične funkcije, moramo ustrezno ovrednotiti in pri tem pretehtati, ali možna korist zdravljenja z Zometo odtehta možno nevarnost.
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2– 3 months.
Pri odločanju glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov moramo upoštevati, da nastopi učinek zdravljenja čez 2– 3 mesece.
As with other bisphosphonates, Zometa has been associated with reports of renal dysfunction.
Tako kot druge difosfonate, tudi Zometo povezujejo s poročili o disfunkciji ledvic.
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of Zometa and other bisphosphonates as well as use of other nephrotoxic drugs.
Med dejavniki, ki utegnejo zvečati možnost poslabšanja ledvične funkcije so dehidracija, že obstoječa ledvična okvara, več ciklov zdravljenja z Zometo in drugimi difosfonati, pa tudi uporaba drugih nefrotoksičnih zdravil.
While the risk is reduced with a dose of Zometa 4 mg administered over 15 minutes, deterioration in renal function may still occur.
Čeprav se nevarnost zmanjša, če 4- miligramski odmerek Zomete dajemo 15 minut dolgo, pa lahko kljub temu nastopi poslabšanje ledvične funkcije.
Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of Zometa.
Poročali so o poslabšanju ledvične funkcije, napredovanju bolezni do ledvične odpovedi in dialize po začetnem odmerku ali po enkratnem odmerku Zomete.
Increases in serum creatinine also occur in some patients with chronic administration of Zometa at recommended doses for prevention of skeletal related events, although less frequently.
Čeprav redkeje, se zvišanje serumskega kreatinina pojavlja tudi pri nekaterih bolnikih, ki kronično prejemajo Zometo v priporočenih odmerkih za preprečevanje z okostjem povezanih dogodkov.
Patients should have their serum creatinine levels assessed prior to each dose of Zometa.
Bolnikom je treba pred vsakim odmerkom Zomete določiti raven serumskega kreatinina.
Upon initiation of treatment in patients with bone metastases with mild to moderate renal impairment, lower doses of Zometa are recommended.
Po uvedbi zdravljenja pri bolnikih z zasevki v kosteh in blago do zmerno ledvično okvaro priporočajo manjše odmerke Zomete.