FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking this enzyme, Nevirapine Teva, taken in combination with other antiviral medicines, reduces the amount of HIV-1 in the blood and keeps it at a low level.
Slovenian: Če se zdravilo Nevirapine Teva jemlje v kombinaciji z drugimi protivirusnimi zdravili, z zaviranjem tega encima zmanjša koncentracijo virusa HIV-1 v krvi in jo ohranja na nizki ravni.
English: Other information about Nevirapine Teva
Slovenian: Druge informacije o zdravilu Nevirapine Teva
English: Because Nevirapine Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Viramune.
Slovenian: Ker je zdravilo Nevirapine Teva generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Viramune.
English: Nevirapine Teva is never taken on its own.
Slovenian: Zdravila Nevirapine Teva se nikoli ne daje samostojno.
English: The Committee recommended that Nevirapine Teva be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Nevirapine Teva izda dovoljenje za promet.
English: The active substance in Nevirapine Teva, nevirapine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Slovenian: Zdravilna učinkovina zdravila Nevirapine Teva, nevirapin, je nenukleozidni zaviralec reverzne transkriptaze (NNRTI).
English: Therefore, the CHMP's view was that, as for Viramune, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi, tako kot pri zdravilu Viramune, odtehtajo znana tveganja.
English: Nevirapine Teva is a ‘generic medicine'.
Slovenian: Nevirapine Teva je „generično zdravilo“.
English: Nevirapine Teva is a medicine that contains the active substance nevirapine.
Slovenian: Nevirapine Teva je zdravilo, ki vsebuje zdravilno učinkovino nevirapin.
English: Why has Nevirapine Teva been approved?
Slovenian: Zakaj je bilo zdravilo Nevirapine Teva odobreno?
English: Nevirapine Teva is an antiviral medicine.
Slovenian: Nevirapine Teva je protivirusno zdravilo.
English: How has Nevirapine Teva been studied?
Slovenian: Kako je bilo zdravilo Nevirapine Teva raziskano?
English: What is Nevirapine Teva?
Slovenian: Kaj je zdravilo Nevirapine Teva?
English: What is Nevirapine Teva used for?
Slovenian: Za kaj se zdravilo Nevirapine Teva uporablja?
English: How is Nevirapine Teva used?
Slovenian: Kako se zdravilo Nevirapine Teva uporablja?
English: How does Nevirapine Teva work?
Slovenian: Kako zdravilo Nevirapine Teva deluje?
English: Strength Pharmaceutical Form
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja o č
English: An updated RMP should be submitted:
Slovenian: Posodobljeni RMP je treba predložiti:
English: Any SRE (+TIH)
Slovenian: Kateri koli SRE (+TIH)
English: The most common ones are usually mild and will probably disappear after a short time.
Slovenian: Najpogostejši so navadno blagi in bodo verjetno v kratkem času izzveneli.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23.08.2012
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 23.08.2012
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 5.1, vendar priporočil glede odmerjanja ni mogoče dati.
English: Tell your doctor if you are or think that you may be pregnant.
Slovenian: Povejte zdravniku, če mislite, da ste noseči ali da bi utegnili zanositi.
English: Date of latest renewal: 24.05.2017
Slovenian: Datum zadnjega podaljšanja: 24.05.2017
English: Estrada do Rio da Mó , nº 8, 8-A e 8-B Fervença, Terrugem SNT, 2705-906 Portugal
Slovenian: Estrada do Rio da Mó, nº 8, 8-A e 8-B Fervença, Terrugem SNT, 2705-906 Portugalska
English: Effects on ability to drive and use machines
Slovenian: Vpliv na sposobnost vožnje in upravljanja s stroji
English: CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
Slovenian: CLcr se izračuna iz vrednosti serumskega kreatinina s Cockcroft-Gaultovo formulo.
English: As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
Slovenian: Ker so za bolnike s hudo insuficienco jeter na voljo le omejeni klinični podatki, za to skupino bolnikov specifičnih priporočil ni mogoče dati.
English: - If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Slovenian: - Če imate težave z ledvicami, vam bo zdravnik dal manjši odmerek, ki bo odvisen od tega, kako hude so vaše težave z ledvicami.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati, oznaka ATC: M05BA08.
English: - A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Slovenian: - okvara v delovanju ledvic, imenovana Fanconijev sindrom (običajno jo ugotovi zdravnik s pomočjo določenih preiskav urina).
English: - Storage conditions of the diluted solution are described in the above paragraph (See “How to prepare and administer Zoledronic acid Mylan”).
Slovenian: - Pogoji shranjevanja raztopine po redčenju so opisani v zgornjem odstavku (glejte “Kako pripraviti in dajati zdravilo Zoledronska kislina Mylan”).
English: Tell your doctor about any of the following side effects as soon as possible:
Slovenian: Čimprej povejte zdravniku za katerega koli od naslednjih neželenih učinkov:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Zdravilo, namenjeno izključno za uporabo na točno določenih specializiranih področjih (glejte Priloga I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: If a lower dose of Zoledronic acid Mylan is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Slovenian: Če je potreben manjši odmerek zdravila Zoledronska kislina Mylan, najprej odvzemite ustrezni volumen, kot je navedeno spodaj, in ga nato dodatno razredčite s 100 ml infuzijske raztopine.
English: Zoledronic acid Mylan can be given to people aged 65 years and over.
Slovenian: Zdravilo Zoledronska kislina Mylan se lahko daje ljudem, ki so stari 65 let ali več.
English: Additional information on handling of Zoledronic acid Mylan, including guidance on preparation of reduced doses, is provided in section 4.2.
Slovenian: Nadaljnje informacije o ravnanju z zdravilom Zoledronska kislina Mylan, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.
English: If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Slovenian: Če nastopi hipokalciemija, hipofosfatemija ali hipomagneziemija, je treba uvesti kratkoročno dopolnilno zdravljenje.
English: Baseline creatinine clearance (ml/min)
Slovenian: Izhodiščna vrednost očistka kreatinina (ml/min)
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic acid Mylan.
Slovenian: - Če prejemate zdravilo za zniževanje količine kalcija v krvi, boste običajno prejeli samo eno infuzijo zdravila Zoledronska kislina Mylan.
English: Tell your doctor about any of the following serious side effects straight away:
Slovenian: Nemudoma povejte zdravniku, če imate katerega od naslednjih resnih neželenih učinkov:
English: Clinical trial results in the treatment of severe osteogenesis imperfecta in paediatric patients aged 1 to 17 years
Slovenian: Rezultati kliničnih preskušanj zdravljenja hude oblike osteogenesis imperfecta pri pediatričnih bolnikih, starih od 1 do 17 let
English: The dose must be given as a single intravenous infusion over no less than 15 minutes.
Slovenian: Odmerek je potrebno dati v obliki ene same intravenske infuzije v času, ki ne sme biti krajši od 15 minut.
English: Each vial contains 5 ml of concentrate.
Slovenian: Vsaka viala vsebuje 5 ml koncentrata.
English: - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic acid Mylan and inform your doctor about your dental treatment.
Slovenian: - če si zdravite zobe ali če boste imeli zobozdravstveno operacijo, povejte svojemu zobozdravniku, da se zdravite z zdravilom Zoledronska kislina Mylan in obvestite svojega zdravnika o zdravljenju zob.
English: How often you will be given Zoledronic acid Mylan - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid Mylan every three to four weeks.
Slovenian: Kako pogosto boste prejeli zdravilo Zoledronska kislina Mylan - Če prejemate zdravilo za preprečevanje zapletov na kosteh zaradi kostnih metastaz, boste prejeli eno infuzijo zdravila Zoledronska kislina Mylan vsake tri do štiri tedne.
English: Very common (may affect more than 1 in 10 people): - Low level of phosphate in the blood.
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): - nizka raven fosfata v krvi.
English: Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.
Slovenian: Bolniki z nezdravljeno hiperkalciemijo imajo na splošno bolj ali manj izraženo okvaro delovanja ledvic, zato je treba razmisliti o skrbnem spremljanju ledvične funkcije.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: Natisnjeno Navodilo za uporabo mora vsebovati ime in naslov imetnika dovoljenja za izdelavo zdravila, odgovornega za sproščanje serij tega zdravila.
English: 1 Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid (see section 4.8)
Slovenian: 1 Neželene učinke s pogostnostjo < 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zoledronske kisline (glejte poglavje 4.8).
English: 1.0 mg/dl or 88 μmol/l.
Slovenian: zvišanje za 1,0 mg/dl ali 88 µmol/l.
English: - Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Slovenian: - huda alergijska reakcija: zadihanost, otekanje zlasti obraza in žrela oziroma grla.
English: Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Slovenian: Zoledronske kisline se ne priporoča bolnikom, ki imajo že pred uvedbo zdravljenja hudo ledvično okvaro, ki je za to skupino bolnikov opredeljena kot CLcr < 30 ml/min.
English: While being treated with Zoledronic acid Mylan, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Slovenian: V času zdravljenja z zdravilom Zoledronska kislina Mylan morate skrbeti za dobro ustno higieno (kar vključuje redno čiščenje zob) in redno hoditi na rutinske preglede k zobozdravniku.
English: - if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Slovenian: - če imate ali ste imeli bolečino, oteklino ali odrevenelost čeljusti, občutek pritiska v čeljusti ali če se vam maje zob.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Slovenian: Preglednica 3: Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate) Kateri koli SRE (+TIH)
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje zoledronsko kislino, za vse podskupine pediatrične populacije glede zdravljenja tumorsko povzročene hiperkalciemije in preprečevanja z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Zoledronic acid has been associated with reports of renal dysfunction.
Slovenian: Zoledronsko kislino povezujejo s poročili o ledvični disfunkciji.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če zdravstveni delavec raztopine ne uporabi takoj, je sam odgovoren za trajanje in pogoje shranjevanja pred uporabo, kar ponavadi ne traja dalj kot 24 ur pri temperaturi 2ºC - 8ºC, razen, če je bilo redčenje izvedeno v nadzorovanih in validiranih aseptičnih pogojih.
English: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Slovenian: Neravnovesja, ki so ga opažali v tem preskušanju, niso opažali v drugih preskušanjih z zoledronsko kislino, vključno s preskušanji z zoledronsko kislino v odmerku 4 mg vsake 3 - 4 tedne pri onkoloških bolnikih.
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of zoledronic acid.
Slovenian: Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zoledronske kisline.
English: - From a microbiological point of view, the diluted solution for infusion should be used immediately.
Slovenian: Z mikrobiološkega stališča je razredčeno raztopino za infundiranje najbolje uporabiti takoj.
English: The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Slovenian: Naslednji neželeni učinki, navedeni v preglednici 1, so zbrani iz kliničnih študij in iz poročanj v obdobju trženja, ki so sledili pretežno kroničnemu zdravljenju s 4-miligramsko zoledronsko kislino:
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Slovenian: Preglednica 6: Neželeni učinki, ki so jih opažali pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta1
English: In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
Slovenian: V študijah faze I za ugotavljanje odmerka pri bolnikih z blago do zmerno hiperkalciemijo, povzročeno s tumorjem (TIH), so bili testirani učinkoviti odmerki v razponu približno 1,2 - 2,5 mg.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Slovenian: Intravensko aplicirana zoledronska kislina se odstranjuje iz telesa s trifaznim procesom: hitro dvofazno izginotje iz sistemskega krvnega obtoka z razpolovnima časoma t1/2 0,24 ure in t1/2 1,87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t1/2 146 ur.
English: How to store Zoledronic acid Mylan Your doctor, pharmacist or nurse knows how to store Zoledronic acid Mylan properly.
Slovenian: Shranjevanje zdravila Zoledronska kislina Mylan Vaš zdravnik, farmacevt ali medicinska sestra vedo, kako je treba zdravilo Zoledronska kislina Mylan pravilno shranjevati.
English: Healthcare professionals are advised not to dispose of unused Zoledronic acid Mylan via the domestic sewage system.
Slovenian: Zdravstvenim delavcem svetujemo, da neporabljenega zdravila Zoledronska kislina Mylan ne izlijejo v gospodinjske odplake.
English: The following conventional classification is used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so opredeljene z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: For instructions on the dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije in redčenja zdravila pred dajanjem glejte poglavje 6.6.
English: The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid-treated group versus 49.6% in the placebo group (p=0.003).
Slovenian: Delež bolnic z vsaj enim SRE (razen hiperkalciemije) je bil v skupini, zdravljeni z zoledronsko kislino 29,8 % v primerjavi s skupino s placebom, kjer je bil 49,6 % (p = 0,003).
English: Median time to onset of the first SRE was not reached in the zoledronic acid-treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
Slovenian: V skupini, zdravljeni z zoledronsko kislino, mediana časa do pojava prvega SRE ob koncu študije še ni bila dosežena, bila je signifikantno podaljšana v primerjavi s placebom (p = 0,007).
English: While the risk is reduced with a dose of 4 mg zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Slovenian: Čeprav se nevarnost zmanjša, če se 4-miligramski odmerek zoledronske kisline daje v času, ki ni krajši od 15 minut, lahko kljub temu nastopi poslabšanje ledvične funkcije.
English: Zoledronic acid Mylan is supplied as packs containing 1, 4 or 10 vials or as multipacks comprising 4 packs, each containing 1 vial.
Slovenian: Zdravilo Zoledronska kislina Mylan je na voljo v ovojnini, ki vsebuje 1 vialo, 4 viale ali 10 vial ali v obliki skupnega pakiranja s 4 vialami, od katerih vsako vsebuje po 1 vialo.
English: 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.
Slovenian: Pri odločanju glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov je treba upoštevati, da nastopi učinek zdravljenja čez 2 - 3 mesece.
English: Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of Zoledronic acid Mylan along with driving and operating of machinery.
Slovenian: Neželena učinka, kot sta na primer vrtoglavica in zaspanost, lahko vplivata na sposobnost vožnje in upravljanja s stroji, zato je ob uporabi zdravila Zoledronska kislina Mylan potrebna previdnost.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C.
Slovenian: Če zdravstveni delavec raztopine ne uporabi takoj, je sam odgovoren za trajanje in pogoje shranjevanja pred uporabo, kar ponavadi ne traja dalj kot 24 ur pri temperaturi 2 ºC8 ºC.
English: In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 μmol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 μmol/l or ≥ 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of zoledronic acid is not recommended in patients with severe renal impairment.
Slovenian: Glede na možni vpliv zoledronske kisline na delovanje ledvic ob pomanjkanju kliničnih podatkov o varnosti pri bolnikih s hudo izhodiščno okvaro ledvic (v kliničnih študijah opredeljeno z vrednostmi serumskega kreatinina ≥ 400 µmol/l ali ≥ 4,5 mg/dl za bolnike s tumorsko povzročeno hiperkalciemijo - TIH - oziroma z vrednostmi serumskega kreatinina ≥ 265 µmol/l ali ≥ 3,0 mg/dl za bolnike z rakom in zasevki v kosteh) in glede na samo omejene farmakokinetične podatke pri bolnikih s hudo izhodiščno okvaro ledvic (očistek kreatinina < 30 ml/min), se uporabe zoledronske kisline pri bolnikih s hudo okvaro ledvic ne priporoča.
English: The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Slovenian: Priporočeni odmerek za hiperkalciemijo (za albumin korigirana vrednost serumskega kalcija ≥ 12,0 mg/dl ali 3,0 mmol/l) je enkratni odmerek 4 mg zoledronske kisline.
English: Zoledronic acid Mylan contains the same active substance as found in medicinal products indicated for treatment of osteoporosis and Paget´s disease of the bone.
Slovenian: Zdravilo Zoledronska kislina Mylan vsebuje isto učinkovino (zoledronsko kislino) kot zdravila, ki so indicirana za zdravljenje osteoporoze in Pagetove bolezni kosti.
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so razvrščeni glede na padajočo pogostnost, najprej najpogostejši, skladno z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Slovenian: vrtoglavica, parestezija, disgevzija, hipestezija, hiperestezija, tremor, somnolenca zelo redki:
English: Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Slovenian: - Osteonekrozo so zelo redko opažali tudi na drugih kosteh in ne le na čeljustnici, še posebej na kolku in stegnu.
English: Following initiation of therapy, serum creatinine should be measured prior to each dose of zoledronic acid and treatment should be withheld if renal function has deteriorated.
Slovenian: Po uvedbi terapije je treba izmeriti vrednosti serumskega kreatinina pred vsakim odmerkom zoledronske kisline, terapijo pa je treba prekiniti v primeru poslabšanja funkcije ledvic.
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Slovenian: V kliničnih študijah so z zdravljenjem z zoledronsko kislino nadaljevali šele, ko se je vrednost kreatinina vrnila na raven, ki ne presega izhodiščne vrednosti za več kot 10 % (glejte poglavje 4.4).
English: Instructions for preparing reduced doses of Zoledronic acid Mylan: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose
Slovenian: Navodila za pripravo zmanjšanih odmerkov zdravila Zoledronska kislina Mylan: Odvzemite ustrezni volumen rekonstituirane raztopine (4 mg/5 ml), kot sledi: - 4,4 ml za odmerek 3,5 mg