natgillin/translations-raw huggingface dataset:
Anasarca, asthenia, chest tightness, chest discomfort
anasarka, astenija, stiskanje v prsih, občutek neugodja v prsnem košu
Livensa 300 micrograms/24 hours transdermal patch Testosterone
Livensa 300 mikrogramov/24 ur transdermalni obliž Testosteron
Eye disorders
- pordelost oči
8 transdermal patches
8 transdermalnih obližev 24 transdermalnih obližev
NAME OF THE MEDICINAL PRODUCT Livensa 300 micrograms/24 hours transdermal patch
IME ZDRAVILA Livensa 300 mikrogramov/24 ur transdermalni obliž
Hepatic impairment No studies have been conducted in patients with hepatic impairment.
Študij pri bolnikih z okvarjenim delovanjem jeter niso izvajali.
How to stick on the patch
Kam nalepiti obliž
Remove the patch.
Navodilo shranite.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Livensa 300 micrograms/24 hours transdermal patch Testosterone
IME ZDRAVILA IN POT(I) UPORABE Livensa 300 mikrogramov/24 ur transdermalni obliž Testosteron
Therefore, based on the safety profile in Livensa, which requires the submission of 6 monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Zato je Odbor za zdravila za uporabo v humani medicini na podlagi varnostnega profila zdravila Livensa, za katerega je treba periodično poročilo o varnosti zdravila predložiti vsakih 6 mesecev,
Always use Livensa exactly as your doctor has told you.
Pri uporabi zdravila Livensa natančno upoštevajte zdravnikova navodila.
Breastfeeding Livensa must not be used by breast-feeding women.
Previdnostni ukrepi Zdravila Livensa se ne sme uporabljati pri ženskah po naravni menopavzi
Acrylic co-polymer adhesive containing 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone co-polymer.
Samolepilna matriksna plast, ki vsebuje zdravilo sorbitanoleat akrilno kopolimerno lepilo, ki vsebuje 2-etilheksilakrilat - 1-vinil-2-pirolidonski kopolimer
You should check with your doctor or pharmacist if you are not sure of the instructions or if you want any more information.
Če ste negotovi, da razumete navodila, ali če želite dodatne informacije, se posvetujte z zdravnikom ali s farmacevtom.
THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription.
Izdaja zdravila je le na recept.
Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4 64331 Weiterstadt Germany
Dr.-Otto-Röhm-Strasse 2-4
Reproductive system and breast disorders
Infekcijske in parazitske bolezni sinuzitis
Baseline
Livensa.
The mode of administration of Livensa makes overdose unlikely.
4.9 Preveliko odmerjanje Zaradi načina odmerjanja zdravila Livensa preveliko odmerjanje ni verjetno.
Information to appear on the inside of the flap
Podatki na notranji strani zavihka Kdaj namestiti obliž:
Special populations
Posebna opozorila
B. PACKAGE LEAFLET
DODATEK IV
Press the sticky side of the patch firmly into place for about 10 seconds.
10 sekund močno pritisnite na kožo.
Where to stick the patch - Stick the patch onto your lower abdomen, below your waist.
Obliž nalepite na spodnji del trebuha, pod pas.
- Keep out of the reach and sight of children - Do not use Livensa after the expiry date which is stated on the carton and sachet after EXP.
Zdravila Livensa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in zaščitni vrečici poleg oznake EXP/Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Tabulated list of adverse reactions
Seznam neželenih učinkov v obliki razpredelnice
The significance of these data for the use of Livensa in patients is not known.
Livensa pri bolnicah ni znan.
Very common Common
Pogosti
Subgroup analyses suggested that the route and type of concomitant estrogen (transdermal oestradiol, oral conjugated equine estrogen (CEE), oral non-CEE) can influence patient response.
Analiza podskupin je nakazala, da lahko na odziv bolnic vpliva način uporabe in vrsta estrogena
NAME OF THE MEDICINAL PRODUCT Livensa 300 micrograms/24 hours transdermal patch Testosterone
NAVODILO ZA UPORABO Livensa 300 mikrogramov/24 ur transdermalni obliž Testosteron
please tell your doctor or pharmacist.
Zdravniku takoj povejte:
The CHMP decided that the MAH should continue to submit 6 monthly PSURs.
Odbor za zdravila za uporabo v humani medicini se je odločil, da naj imetnik dovoljenja za promet z zdravilom predloži periodično poročilo o varnosti zdravila vsakih 6 mesecev.
Livensa is not recommended in naturally
Uporaba zdravila Livensa se ne priporoča ženskam po naravni menopavzi.
Blood and lymphatic system
Bolezni krvi in limfatičnega nenormalni faktor strjevanja krvi
Arthritis
Dojenje
Abnormal clotting factor
- sinusitis (vnetje nosnih sinusov) - nenormalen faktor strjevanja krvi
Increased appetite
Presnovne in prehranske motnje povečanje apetita
Each pack contains the vial with concentrate.
Vsaka škatla vsebuje vialo s koncentratom.
Date of latest renewal: 20th November 2018
Datum prve odobritve: 16.01.2014 Datum zadnjega podaljšanja: 20. novembra 2018
Packs containing 1, 4 or 10 vials.
Pakiranje vsebuje 1, 4 ali 10 vial.
EXP Use immediately after dilution.
EXP Uporabite takoj po redčenju.
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention:
Neželeni učinki so razvrščeni glede na pogostnost, najprej najpogostejši, in to po naslednjem dogovoru:
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.
Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Accord properly (see section 6).
Vaš zdravnik, farmacevt ali medicinska sestra vedo, kako je treba zdravilo Zoledronska kislina Accord pravilno shranjevati (glejte poglavje 6).
Zoledronic Acid Accord can be given to people aged 65 years and over.
Zdravilo Zoledronska kislina Accord lahko dajemo ljudem, ki so stari 65 let ali več.
• 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.
Very common (may affect more than 1 in 10 people): • Low level of phosphate in the blood.
Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 ljudi): nizka koncentracija fosfata v krvi.
If a lower dose of Zoledronic Acid Accord is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Če je potreben manjši odmerek zdravila Zoledronska kislina Accord, najprej odvzemite ustrezni volumen, kot je navedeno spodaj, in ga nato dodatno razredčite s 100 ml infuzijske raztopine.
• If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
- Če imate težave z ledvicami, vam bo zdravnik dal manjši odmerek, ki bo odvisen od tega, kako hude so vaše težave z ledvicami.
Additional information on handling of Zoledronic Acid Accord, including guidance on preparation of reduced doses, is provided in section 4.2.
Nadaljnje informacije o ravnanju z zdravilom Zoledronska kislina Accord, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.
Other medicines and Zoledronic Acid Accord Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Zoledronska kislina Accord Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Chemical and physical in-use stability has been demonstrated for 36 hours at 2 - 8 °C.
- Kemijska in fizikalna stabilnost je bila dokazana med uporabo 36 ur pri 2-8 ° C.
In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several anti-tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Poleg tega, da je zoledronska kislina močan inhibitor resorpcije kosti, ima tudi več protitumorskih lastnosti, ki bi lahko prispevale k njeni celotni učinkovitosti v zdravljenju metastatične bolezni kosti.
• A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
okvara v delovanju ledvic, imenovana Fanconijev sindrom (običajno jo ugotovi zdravnik s pomočjo določenih preiskav urina).
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Glede bolnikov, pri katerih so potrebni zobozdravstveni postopki, ni na voljo nikakršnih podatkov, ki bi kazali na to, ali prekinitev difosfonatnega zdravljenja zmanjša tveganje osteonekroze čeljustnic.
In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralization or mechanical properties of bone.
V dolgoročnih raziskavah na živalih zoledronska kislina zavira resorpcijo kosti, ne da bi neugodno vplivala na oblikovanje, mineralizacijo ali mehanske lastnosti kosti.
Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1
Preglednica 6: Neželeni učinki, ki so jih opažali pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta1
* Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR-Not Reached
* zajema vertebralne in nevertebralne zlome; ** velja za vse skeletne dogodke, tako za njihovo celotno število kot za trajanje vsakega dogodka med preskušanjem;
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, S PROSTORNINO ALI ŠTEVILOM ENOT
• Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zoledronic Acid Accord.
Študije z več vrstami infuzijskih sistemov, izdelanih iz polivinilklorida, polietilena in polipropilena, niso pokazale nezdružljivosti z zdravilom Zoledronska kislina Accord.
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 Accord along with driving and operating of machinery.
Neželeni učinki, kot na primer vrtoglavost in somnolenca, lahko vplivajo na sposobnost vožnje in upravljanja s stroji, zato je ob uporabi zdravila Zoledronska kislina Accord potrebna previdnost pri vožnji in upravljanju s stroji.
• 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 Accord.
- Če prejemate zdravilo za zniževanje količine kalcija v krvi, boste običajno prejeli samo eno infuzijo zdravila Zoledronska kislina Accord.
For instructions on the dilution of zoledronic acid before administration, see section 6.6.
Za navodila glede redčenja zoledronske kisline pred dajanjem glejte poglavje 6.6.
Healthcare professionals are advised not to dispose of unused Zoledronic Acid Accord via the domestic sewage system.
Zdravstvenim delavcem svetujemo, da neporabljenega zdravila Zoledronska kislina Accord ne izlijejo v gospodinjske odplake.
Zoledronic acid treatment should be resumed at the same dose as that given prior to treatment interruption.
Zdravljenje z zoledronsko kislino je treba spet začeti z enakim odmerkom kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
Treatment of TIH Adults and older people
Odrasli in starejši ljudje
Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
Zoledronska kislina ne kaže znatne vezave na plazemske beljakovine in ne zavira humanih encimov P450 in vitro (glejte poglavje 5.2), niso pa bile narejene formalne klinične študije medsebojnega delovanja.
PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate) Clear and colourless solution.
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) bistra in brezbarvna raztopina
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.
Zoledronske kisline ne priporočajo bolnikom, ki imajo že pred uvedbo zdravljenja težko ledvično okvaro, ki je za to skupino bolnikov opredeljena kot CLcr < 30 ml/min.
Hypophosphataemia 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)
hipofosfatemija 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).
The study treatment period was 12 months preceded by a 4- to 9-week screening period during which vitamin D and elemental calcium supplements were taken for at least 2-weeks.
Obdobje zdravljenja v študiji je trajalo 12 mesecev, pred tem so imeli bolniki 4- do 9-tedensko obdobje presejanja (screening), v katerem so bolniki vsaj 2 tedna jemali vitamin D in nadomestke z elementarnim kalcijem.
Zoledronic acid should not be used during pregnancy.
Zoledronske kisline ne smete uporabljati med nosečnostjo.
The European Medicines Agency has waived the obligation to submit the results of studies with the reference 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).
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).
The diluted Zoledronic Acid Accord infusion solution should be used immediately in order to avoid microbial contamination.
Razredčeno infuzijsko raztopino zdravila Zoledronska kislina Accord morate porabiti takoj, da bi preprečili onesnaženje z mikroorganizmi.
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.
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.
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 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
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 redčenje potekalo pod kontroliranimi in validiranimi aseptičnimi pogoji.
Zoledronic Acid Accord treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Zdravljenje z zdravilom Zoledronska kislina Accord pri bolnikih s TIH, ki imajo tudi težko ledvično okvaro, lahko pride v poštev šele po oceni nevarnosti in koristnih učinkov zdravljenja.
Zoledronic Acid Accord 4 mg concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Zdravilo Zoledronska kislina Accord 4 mg koncentrat za raztopino za infundiranje, nadaljnje razredčeno v 100 ml (glejte poglavje 6.6), je treba dajati v obliki ene same intravenske infuzije, ki traja najmanj 15 minut.
In the clinical trials, renal deterioration was defined as follows: For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 µmol/l), an increase of 0.5 mg/dl or 44 µmol/l; For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of 1.0 mg/dl or 88 µmol/l.
V kliničnih preskušanjih so opredelili ledvično poslabšanje takole: pri bolnikih z normalnim izhodiščnim serumskim kreatininom (< 1,4 mg/dl ali < 124µmol/l), zvišanje za 0,5 mg/dl ali 44 µmol/l; pri bolnikih s patološkim izhodiščnim kreatininom (> 1,4 mg/dl ali > 124 µmol/l), zvišanje za 1,0 mg/dl ali 88 µmol/l.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni "brez natrija".
From a microbiological point of view, the diluted solution for infusion should be used immediately.
Z mikrobiološkega stališča je razredčeno raztopino za infundiranje najbolje uporabiti takoj.
This medicinal product does not require any special storage condition.
Za shranjevanje zdravila niso potrebna posebna navodila.
• Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
huda alergijska reakcija: zadihanost, otekanje zlasti v obraz in žrelo oziroma grlo.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI MEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
In-vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer drugs, anti-adhesion/invasion activity.
In vitro: Inhibicijo proliferacije osteoblastov, neposredno citostatično in pro-apoptotično aktivnost pri tumorskih celicah, sinergističen citostatični učinek z drugimi zdravili proti raku, anti-adhezijsko in anti-invazijsko aktivnost.
Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Zdravljenje odraslih bolnikov s tumorsko povzročeno hiperkalciemijo (TIH).
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.
Intravensko dana 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.
• Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
- Skrbno se ravnajte tudi po vseh drugih navodilih, ki jih dobite od svojega zdravnika, farmacevta ali medicinske sestre.
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.
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.
• The other ingredients are: mannitol, sodium citrate, water for injections.
Druge sestavine so: manitol, natrijev citrat, voda za injekcije.
Very rare (may affect up to 1 in 10,000 people):
Zelo redki (lahko se pojavijo pri 1 od 10.000 ljudi):
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Accord.
Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zdravila Zoledronska kislina Accord.
Zoledronic Acid Accord is supplied as packs containing 1, 4 or 10 vials.
Zdravilo Zoledronska kislina Accord je na voljo v ovojnini, ki vsebuje 1 vialo, 4 viale ali 10 vial.
• The unopened vial does not require any specific storage conditions.
Za shranjevanje neodprte viale niso potrebna posebna navodila.
Zoledronic acid 4 mg significantly reduced the proportion of patients experiencing at least one skeletal related event (SRE), delayed the median time to first SRE by > 5 months, and reduced the annual incidence of events per patient-skeletal morbidity rate.
Zoledronska kislina 4 mg je značilno (signifikantno) zmanjšala delež bolnikov, ki so doživeli vsaj po en z okostjem povezan dogodek (SRE), odložila mediano časa nastopa prvega z okostjem povezanega dogodka (SRE) za > 5 mesecev in zmanjšala letno incidenco dogodkov na bolnika - stopnjo obolevnosti skeleta.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/834/001- 1vial pack EU/1/13/834/002- 4 vial pack EU/1/13/834/003- 10 vial pack
EU/1/13/834/001-1 viala EU/1/13/834/002- 4 viale EU/1/13/834/003-10 vial
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.
Priporočeni odmerek za hiperkalciemijo (za albumin korigirani serumski kalcij ≥ 12,0 mg/dl ali 3,0 mmol/l) je enkratni odmerek 4 mg zoledronske kisline.
Excipients: mannitol (E421), sodium citrate and water for injections.
Pomožne snovi: manitol (E421), natrijev citrat in voda za injekcije.
Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Accord and will check your response to treatment at regular intervals.
Preden začnete zdravljenje z zdravilom Zoledronska kislina Accord, vam bo zdravnik opravil preiskave krvi in v rednih presledkih preverjal vaš odziv na zdravljenje.
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).
V kliničnih študijah so nadaljevali z zdravljenjem z zoledronsko kislino šele, ko se je koncentracija kreatinina vrnila na raven, ne za več kot 10 % višjo od izhodiščne vrednosti (glejte poglavje 4.4).
Table 5: Proportion of complete responders by day in the combined TIH studies
Preglednica 5: Delež bolnikov s popolnim odzivom po dnevih v združenih raziskavah tumorsko povzročene hiperkalciemije (TIH)
Median time to relapse (re-increase of albumin-corrected serum calcium ≥ 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Mediana časa do ponovnega pojava bolezni (ponovno zvišanje za albumin korigiranega serumskega kalcija  2,9 mmol/l) je bila pri bolnikih, zdravljenih z zoledronsko kislino, 30 do 40 dni, pri tistih, ki so bili zdravljeni s pamidronatom 90 mg, pa 17 dni (vrednosti p: 0,001 za 4 mg in 0,007 za 8 mg zoledronske kisline).
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.
Glede na možni vpliv zoledronske kisline na delovanje ledvic ob pomanjkanju kliničnih podatkov o varnosti pri bolnikih s težko izhodiščno okvaro ledvic (v kliničnih preskušanjih opredeljeno s serumskim kreatininom ≥ 400 µmol/l ali ≥ 4,5 mg/dl za bolnike s tumorsko povzročeno hiperkalciemijo - TIH - oziroma s serumskim kreatininom ≥ 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 težko izhodiščno ledvično okvaro (očistek kreatinina < 30 ml/min), uporabe zoledronske kisline pri bolnikih s težko ledvično okvaro ne priporočamo.
• Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Osteonekrozo so zelo redko opažali tudi na drugih kosteh in ne le na čeljustnici, še posebej na kolku in stegnu.
N Proportion of patients with SREs p-value Median time to SRE (days)
N delež bolnikov s SREs (%) vrednost p mediana časa do SRE (dnevi)
Musculoskeletal pain
Mišično- skeletne bolečine