natgillin/translations-raw huggingface dataset:
The CHMP also noted problems with the study data provided by the company, including statistical errors and missing information.
CHMP je odkril tudi pomanjkljivosti v zvezi s podatki iz študij, ki jih je predložila družba, vključno s statističnimi napakami in manjkajočimi informacijami.
While the CHMP was awaiting the company's response to the questions, it requested an inspection of the site where studies with the medicine had taken place.
Medtem ko je CHMP čakal, da družba odgovori na vprašanja, je zahteval pregled lokacije, kjer so potekale študije z zdravilom.
The failures identified were such that the data provided by the company could not be used to evaluate the marketing authorisation application.
Opažene pomanjkljivosti so bile tako velike, da podatkov, ki jih je predložila družba, ni bilo mogoče uporabiti za presojo vloge za odobritev dovoljenja za promet z zdravilom.
In its letter notifying the Agency of the withdrawal of application, the company stated that they decided to withdraw the applications in order to repeat the studies at a validated contract research organisation and to submit additional data.
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge odločila zato, da bi ponovila študije pri priznani pogodbeni raziskovalni organizaciji in predložila dodatne podatke.
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar or when the body is unable to use insulin effectively.
Sladkorna bolezen je bolezen, pri kateri v telesu ne nastaja dovolj insulina za uravnavanje ravni krvnega sladkorja ali pri kateri telo insulina ne more učinkovito izrabiti.
The concerns over the data led the CHMP to request an inspection of Bombay Bioresearch Centre (BBRC) in India, where studies were carried out for Marvel LifeSciences (the sponsor of the studies), and also of Marvel LifeSciences's UK site.
Zaradi pomislekov glede podatkov je CHMP zahteval pregled Bombajskega centra za biološke raziskave (BBRC) v Indiji, kjer so opravljali študije za družbo Marvel LifeSciences (sponzorja študij), ter tudi prostorov družbe Marvel LifeSciences v Združenem kraljestvu.
In addition, the company presented the results from a main study in 432 patients with diabetes comparing the safety and effectiveness of the three medicines from Marvel LifeSciences with their respective reference medicines.
Poleg tega je družba predložila tudi rezultate glavne študije pri 432 bolnikih s sladkorno boleznijo, v kateri so primerjali varnost in učinkovitost treh zdravil družbe Marvel LifeSciences z ustreznimi referenčnimi zdravili.
The insulin in Combimarv is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Insulin v zdravilu Combimarv se pridobiva z metodo, imenovano „tehnologija rekombinantne DNK“: izdela ga bakterija, ki je prejela gen (DNK), s pomočjo katerega lahko tvori insulin.
The initial concerns related mainly to the manufacture of the medicine and whether Combimarv was sufficiently similar to its reference medicine.
Prvotni pomisleki so bili v glavnem povezani s proizvodnjo zdravila in z vprašanjem, ali je zdravilo Combimarv dovolj podobno referenčnemu zdravilu.
On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Combimarv, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Družba Marvel LifeSciences Ltd je dne 15. novembra 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Combimarv, namenjenim zdravljenju bolnikov s sladkorno boleznijo, ki potrebujejo insulin za uravnavanje glukoze v krvi.
The company informed the CHMP that at the time of the withdrawal no patients were receiving Combimarv in clinical trials.
Družba je CHMP obvestila, da v času umika vloge ni bilo bolnikov, ki bi v kliničnih študijah prejemali zdravilo Combimarv.
Withdrawal of the marketing authorisation application for Combimarv (human insulin)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Combimarv (humani insulin)
Combimarv is a medicine that contains the active substance human insulin.
Combimarv je zdravilo, ki vsebuje zdravilno učinkovino humani insulin.
Among these were results from studies that looked at how the body handles Combimarv compared with Humulin M3 and how these insulins affect blood sugar levels.
Med rezultati so bili tudi rezultati študij, v katerih so proučevali, kako se telo odziva na zdravilo Combimarv v primerjavi z zdravilom Humulin M3, in kako omenjena insulina vplivata na ravni krvnega sladkorja.
After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Combimarv could not have been approved.
Po oceni začetne dokumentacije je CHMP izrazil velike zadržke in je začasno menil, da zdravila Combimarv ni mogoče odobriti.
What is Combimarv?
Kaj je zdravilo Combimarv?
Combimarv was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Zdravilo Combimarv naj bi se uporabljalo za zdravljenje bolnikov s sladkorno boleznijo, ki potrebujejo insulin za uravnavanje glukoze (sladkorja) v krvi.
The application was a joint application from Marvel LifeSciences for Combimarv and two other medicines (Solumarv and Isomarv medium, also developed as biosimilar medicines).
Vloga, ki jo je predložila družba Marvel LifeSciences, je bila skupna vloga za zdravilo Combimarv in dve drugi zdravili (Solumarv in Combimarv, ki sta bili prav tako razviti kot podobni biološki zdravili).
Combimarv was developed as a biosimilar medicine.
Zdravilo Combimarv je bilo razvito kot biološko podobno zdravilo.
What was Combimarv expected to be used for?
Za kaj naj bi se zdravilo Combimarv uporabljalo?
Combimarv was intended as a replacement insulin that is similar to the insulin made by the body.
Zdravilo Combimarv naj bi bilo nadomestni insulin, ki je podoben insulinu, ki nastaja v telesu.
The company presented the results of studies designed to show that Combimarv is similar to its reference medicine Humulin M3 in terms of its structure, biological activity and clinical performance.
Družba je predložila rezultate študij, ki naj bi dokazale, da je zdravilo Combimarv po svoji sestavi, biološki aktivnosti in klinični učinkovitosti podobno referenčnemu zdravilu Humulin M3.
Withdrawal of the marketing authorisation application for Combimarv (human insulin) EMA/CHMP/800908/2012
Umik vloge za pridobitev dovoljenja za promet z zdravilom Combimarv (humani insulin) EMA/130454/2013
How is Combimarv expected to work?
Kako naj bi zdravilo Combimarv delovalo?
The reference medicine for Combimarv in this application was Humulin M3. For more information on biosimilar medicines, see the questions-and-answers document here.
Za več informacij o biološko podobnih zdravilih si oglejte dokument z vprašanji in odgovori tukaj.
London, 19 November 2009 Doc.
London, 19. novembra 2009 Sklic dok.
There was also a lack of data on the long-term effects in a European population.
Na voljo je bilo tudi premalo podatkov o dolgoročnih učinkih v evropski populaciji.
Ref.: EMA/814249/2009 EMEA/H/C/1034 EMEA/H/C/1122
: EMA/64551/2010 EMEA/H/C/1034 EMEA/H/C/1122
The applicant requested a re-examination of the opinion.
Predlagatelj je zahteval ponovno presojo mnenja.
The cause of fibromyalgia is not known.
Vzrok fibromialgije ni znan.
The main measures of effectiveness were based on the patients perceived improvement in symptoms, particularly pain levels and their overall wellbeing.
Glavna merila učinkovitosti so temeljila na izboljšanju simptomov, kot so jih dojemali bolniki, zlasti stopnje bolečine in njihovega splošnega počutja.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 November 2009.
Po proučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 19. novembra 2009 potrdil zavrnitev vloge za dovoljenje za promet.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Živčni prenašalci so kemijske spojine, ki živčnim celicam omogočajo medsebojno komunikacijo.
Since these neurotransmitters are involved in reducing the sensation of pain, it was expected that blocking their re-uptake into nerve cells would improve the symptoms of fibromyalgia.
Ker ti živčni prenašalci sodelujejo pri zmanjšanju občutka bolečine, je bilo pričakovati, da bo zaviranje njihovega ponovnega privzema v živčne celice izboljšalo simptome fibromialgije.
Fibromyalgia can also cause other symptoms such as tenderness, stiffness, tiredness, anxiety and changes in how the patient sleeps, feels and thinks.
Fibromialgija lahko povzroči tudi druge simptome, kot so občutljivost, otrdelost, utrujenost, anksioznost in spremembe bolnikovih vzorcev spanja, čustvovanja in mišljenja.
The CHMP was of the opinion that the effect of the medicine was marginal.
CHMP je menil, da so učinki zdravila obrobnega pomena.
By blocking their re-uptake, milnacipran was expected to increase the level of communication between these nerve cells.
Z zaviranjem njihovega ponovnega privzema naj bi milnacipran povečal stopnjo sporazumevanja med temi živčnimi celicami.
What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
Kateri so bili glavni zadržki, zaradi katerih je CHMP predlagal zavrnitev dovoljenja za promet?
The CHMP refusal was confirmed after re-examination.
Zavrnitev, ki jo je priporočil CHMP, je bila po ponovni presoji mnenja potrjena.
It was expected to work by preventing the neurotransmitters 5hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Deloval naj bi tako, da bi preprečeval ponovni privzem živčnih prenašalcev 5-hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v živčne celice v možganih in hrbtenjačo.
Milnacipran Pierre Fabre Médicament/Impulsor was expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Zdravilo Milnacipran Pierre Fabre Médicament/Impulsor naj bi se uporabljalo za zdravljenje odraslih s fibromialgijo, boleznijo, ki povzroča dolgotrajno, obsežno bolečino in boleče odzive na dotik.
In three main studies, 2,960 adult patients with fibromyalgia were given either Milnacipran Pierre Fabre Médicament/Impulsor or placebo (a dummy treatment) for around four to seven months.
V treh glavnih študijah je 2 960 odraslih bolnikov s fibromialgijo približno štiri do sedem mesecev prejemalo zdravilo Milnacipran Pierre Fabre Médicament/Impulsor ali placebo (zdravilo brez zdravilne učinkovine).
The effects of Milnacipran Pierre Fabre Médicament/Impulsor were first tested in experimental models before being studied in humans.
Učinki zdravila Milnacipran Pierre Fabre Médicament/Impulsor so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Questions and answers on the recommendation for the refusal of the marketing authorisation for Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
Vprašanja in odgovori v zvezi s priporočilom za zavrnitev vloge za dovoljenje za promet z zdravilom Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Milnacipran Pierre Fabre Médicament/Impulsor, intended for the treatment of fibromyalgia in adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 23. julija 2009 priporočil zavrnitev vloge za dovoljenja za promet z zdravilom Milnacipran Pierre Fabre Médicament/Impulsor, namenjenim zdravljenju fibromialgije pri odraslih.
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Milnacipran Pierre Fabre Médicament/Impulsor?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Milnacipran Pierre Fabre Médicament/Impulsor?
The company that applied for authorisation is Pierre Fabre Medicament.
Vlogo za dovoljenje je vložila družba Pierre Fabre Medicament.
The company informed the CHMP that there are currently no ongoing clinical trials with Milnacipran Pierre Fabre Médicament/Impulsor in Europe for fibromyalgia.
Družba je obvestila CHMP, da klinična preskušanja z zdravilom Milnacipran Pierre Fabre Médicament/Impulsor pri bolnikih s fibromialgijo v Evropi trenutno ne potekajo.
Milnacipran Pierre Fabre Médicament/Impulsor is a medicine that contains the active substance milnacipran.
Milnacipran Pierre Fabre Médicament/Impulsor je zdravilo, ki vsebuje zdravilno učinkovino milnacipran.
The active substance in Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, is a ‘serotoninnoradrenaline re-uptake inhibitor'.
Zdravilna učinkovina zdravila Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, je „zaviralec ponovnega privzema serotonina in noradrenalina“.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Milnacipran Pierre Fabre Médicament/Impulsor in the treatment of fibromyalgia did not outweigh its risks.
CHMP je zato takrat menil, da koristi zdravila Milnacipran Pierre Fabre Médicament/Impulsor pri zdravljenju fibromialgije ne odtehtajo z njim povezanih tveganj.
What is Milnacipran Pierre Fabre Médicament/Impulsor?
Kaj je zdravilo Milnacipran Pierre Fabre Médicament/Impulsor?
Hence, the CHMP recommended that Milnacipran Pierre Fabre Médicament/Impulsor be refused marketing authorisation.
Zato je CHMP priporočil zavrnitev dovoljenja za promet z zdravilom Milnacipran Pierre Fabre Médicament/Impulsor.
How was Milnacipran Pierre Fabre Médicament/Impulsor expected to work?
Kako naj bi zdravilo Milnacipran Pierre Fabre Médicament/Impulsor delovalo?
What was Milnacipran Pierre Fabre Médicament/Impulsor expected to be used for?
Za kaj naj bi se zdravilo Milnacipran Pierre Fabre Médicament/Impulsor uporabljalo?
Please open here
Prosimo, odprite tukaj.
The response rate in these patients was about 52%.
Stopnja odzivnosti pri teh bolnikih je bila okrog 52 %.
• At the request of the European Medicines Agency,
• na zahtevo Evropske agencije za zdravila;
Time on study (weeks)
čas v študiji (tedni)
Adults and older people
Odrasli in starejši ljudje
The most common ones are usually mild and will probably disappear after a short time.
Najpogostejši so navadno blagi in bodo verjetno v kratkem času izginili.
Use the entire contents.
Vsebino porabite v celoti.
Any SRE (+TIH)
katerikoli SRE (+TIH)
Patients aged 65 years and over
Bolniki, stari 65 let ali več
You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
Zato morate biti previdni pri upravljanju motornih vozil, uporabi strojev in opravljanju drugih nalog, ki zahtevajo vašo celotno pozornost.
Unopened bottle: 3 years.
Neodprta plastenka: 3 leta
Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days).
V večini primerov ni potrebno nikakršno specifično zdravljenje in simptomi v kratkem (čez nekaj ur ali dni) izzvenijo.
Acquired Fanconi syndrome
pridobljen Fanconijev sindrom
Median time to normocalcaemia was 4 days.
Mediana časa do normalne vrednosti kalcija je bila 4 dni.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Natančno preberite navodilo, preden vam dajo zdravilo, ker vsebuje za vas pomembne podatke!
Mutagenicity and carcinogenic potential
Mutagenost in kancerogeni potencial
Use immediately after first opening.
Uporabite takoj po prvem odpiranju.
Zometa can be given to people aged 65 years and over.
Zdravilo Zometa lahko dajemo ljudem, ki so stari 65 let ali več.
In some instances the hypocalcaemia may be life-threatening.
Hipokalciemija je v nekaterih primerih lahko življenjsko ogrožujoča.
Follow carefully all instructions given to you by your doctor.
Skrbno se ravnajte po vseh navodilih, ki vam jih je dal vaš zdravnik.
CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
CLcr se izračuna iz serumskega kreatinina s Cockcroft-Gaultovo formulo.
Tell your doctor if you are or think that you may be pregnant.
Povejte zdravniku, če mislite, da ste noseči ali da bi utegnili biti noseči.
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
INFORMACIJE ZA ZDRAVSTVENE DELAVCE
Subchronic and chronic toxicity
Subkronična in kronična toksičnost
There is no evidence to suggest that any extra precautions are needed.
Ni dokazov, ki bi kazali, da so potrebni kakšni posebni varnostni ukrepi.
These could be signs of bone damage in the ear.
To so lahko znaki poškodbe kosti v ušesu.
The time to onset of symptoms varied from one day to several months after starting treatment.
Čas do pojava simptomov je bil različen: od enega dneva do nekaj mesecev po začetku zdravljenja.
Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Pozorni moramo biti tudi na možnost, da bi se med zdravljenjem razvila hipomagneziemija.
• To reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
• zniževanje količine kalcija v krvi pri odraslih, kadar je ta prevelika zaradi prisotnosti tumorja.
1.0 mg/dl or 88 µmol/l.
1,0 mg/dl ali 88 µmol/l.
The following response rates were observed:
Ugotovili so naslednje stopnje odzivnosti:
Osteonecrosis of other anatomical sites
Osteonekroza na drugih anatomskih lokacijah
Your doctor, pharmacist or nurse knows how to store Zometa properly (see section 6).
Vaš zdravnik, farmacevt ali medicinska sestra vedo, kako je treba zdravilo Zometa pravilno shranjevati (glejte poglavje 6).
The reconstituted solution is stable for 24 hours at 2°C - 8°C.
Rekonstituirana raztopina je stabilna 24 ur pri 2 °C - 8 °C.
Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Izmed teh bolnikov so številni prejemali tudi kemoterapijo in kortikosteroide in imeli znake lokalne infekcije, vključno z osteomielitisom.
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Skupni telesni očistek je 5,04  2,5 l/h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa in telesna masa.
The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Mehanizem, na katerem temelji zvišana pojavnost atrijske fibrilacije v tem edinem kliničnem preskušanju, ni znan.
Aseptic techniques must be followed during the preparation of the infusion.
Pri pripravljanju infuzije je treba uporabljati aseptične tehnike.
As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
Ker so za bolnike s težko insuficienco jeter na voljo le omejeni klinični podatki, za to skupino bolnikov ne moremo dati specifičnih priporočil.
If the solution is not used immediately, it should be stored in a refrigerator at 2°C - 8°C.
Če raztopine ne uporabite takoj, jo je treba shraniti v hladilnik pri temperaturi 2 °C 8 °C.
Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati, oznaka ATC: M05BA08
There are no adequate data on the use of zoledronic acid in pregnant women.
Ni zadostnih podatkov o uporabi zoledronske kisline pri nosečnicah.
The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Večina poročil se nanaša na bolnike z rakom po ekstrakciji zoba ali drugih zobozdravniških operativnih posegih.
Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
V prvih 24 urah se izloči v urin 39  16 % danega odmerka, preostanek pa se predvsem veže v kostno tkivo.
In some instances, the hypocalcaemia may be life-threatening (see section 4.8).
Hipokalciemija je v nekaterih primerih lahko življenjsko ogrožujoča (glejte poglavje 4.8).
The treatment effects were less pronounced in patients with blastic lesions.
Učinki zdravljenja so bili manj izraziti pri bolnikih z blastnimi lezijami.
If any of these apply to you, tell your doctor straight away.
Če se pri vas razvije karkoli od navedenega, takoj obvestite svojega zdravnika.
Each pack contains the vial with concentrate.
Vsako pakiranje vsebuje vialo s koncentratom.
Other medicines and Zometa Tell your doctor if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Zometa Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
- Zdravnik vam bo priporočil, da pred vsako infuzijo spijete dovolj vode, kar bo pomagalo preprečiti dehidracijo.
What Zometa is and what it is used for
Kaj je zdravilo Zometa in za kaj ga uporabljamo
Since those patients were retreated with the 8 mg dose only, there are no data available allowing comparison with the 4 mg zoledronic acid dose.
Ker so bili ti bolniki ponovno zdravljeni samo z odmerkom 8 mg, ni na voljo podatkov, ki bi omogočali primerjavo z odmerkom 4 mg zoledronske kisline.
Baseline creatinine clearance (ml/min)
Izhodiščni očistek kreatinina (ml/min)
In particular there was no clear evidence of efficacy on incidence of fracture or on pain.
V študiji namreč niso mogli jasno potrditi učinkovitosti na pogostnost zlomov ali na bolečino.
Arthritis and joint swelling as a symptom of acute phase reaction
artritis in otekline sklepov kot simptoma reakcije akutne faze
The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Varnost in učinkovitost zoledronske kisline pri otrocih, starih 1 do 17 let, nista bili dokazani.
- If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zometa.
- Če prejemate zdravilo za zniževanje količine kalcija v krvi, boste običajno prejeli samo eno infuzijo zdravila Zometa.
It is an inhibitor of osteoclastic bone resorption.
Je zaviralec osteoklastne resorpcije kosti.
Most patients had relief of symptoms after stopping treatment.
Pri večini bolnikov je prišlo do olajšanja po prekinitvi zdravljenja.
It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received zoledronic acid.
Zaenkrat ni jasno, ali to nepravilno bitje srca povzroča zoledronska kislina, kljub temu pa morate zdravniku sporočiti, če pri vas pride do takih simptomov po tem, ko ste prejeli zoledronsko kislino.
What you need to know before you are given Zometa
Kaj morate vedeti, preden vam bodo dali zdravilo Zometa
Patients receiving zoledronic acid 4 mg reported less increase in pain than those receiving placebo, and the difference reached significance at months 3, 9, 21 and 24.
Bolniki, ki so dobivali zoledronsko kislino 4 mg, so poročali o manjšem porastu bolečin kot tisti, ki so dobivali placebo, ta razlika pa je dosegla statistično značilnost v 3., 9., 21. in 24. mesecu.
Acute phase reaction, pain
reakcija akutne faze, bolečina
It is used:
Uporabljamo jo za:
Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Kaže, da starost, telesna masa, spol in očistek kreatinina ne vplivajo na sistemsko izpostavljenost zoledronski kislini.