FrancophonIA/ELRC3.0 huggingface dataset:
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Slovenian: Osteonekroza čeljustnic O osteonekrozi čeljustnic so občasno poročali v kliničnih preskušanjih in po začetku trženja zdravila pri bolnikih, ki so prejemali zoledronsko kislino.
English: Respiratory, thoracic and mediastinal disorders Uncommon: Rare:
Slovenian: zamegljen vid, skleritis in orbitalno vnetje redki: zelo redki:
English: After first opening, Zoledronic acid medac solution for infusion should preferably be used immediately.
Slovenian: Raztopino za infundiranje Zoledronska kislina medac je najbolje uporabiti takoj po prvem odpiranju.
English: NA Not applicable
Slovenian: NR ni bil dosežen
English: Zoledronic acid medac 4 mg/100 ml solution for infusion should be given as a single intravenous infusion in no less than 15 minutes.
Slovenian: Zdravilo Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje je treba dajati v obliki ene same intravenske infuzije, ki traja najmanj 15 minut.
English: What Zoledronic acid medac looks like and contents of the pack Zoledronic acid medac is supplied as a concentrate for solution for infusion in a 5 ml plastic vial made of clear, colourless plastic (cycloolefine copolymer) with rubber stopper (type I bromobutyl) and sealed with flip-off seal (aluminium and polypropylene).
Slovenian: Zdravilo Zoledronska kislina medac je v obliki koncentrata za raztopino za infundiranje v 5 ml plastični viali, narejeni iz prozorne, brezbarvne plastike (cikloolefinski kopolimer) z gumijastim zamaškom (tip 1 bromobutil), prevlečena z odtržno zaporko (aluminij ali polipropilen).
English: Table 6: Proportion of complete responders by day in the combined TIH studies
Slovenian: Preglednica 6: Delež bolnikov s popolnim odzivom po dnevih v združenih raziskavah tumorsko povzročene hiperkalciemije (TIH)
English: Zoledronic acid 4 mg
Slovenian: Zoledronska kislina 4 mg 
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Slovenian: Pri uvajanju zdravljenja z zoledronsko kislino pri bolnikih z multiplim mielomom ali metastatičnimi kostnimi lezijami zaradi čvrstih tumorjev je treba določiti serumski kreatinin in očistek kreatinina (CLcr).
English: Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Slovenian: Po pregledu podatkov kliničnih preskušanj in primerov, ki so jih opažali po prihodu zdravila na trg, je na voljo dovolj dokazov, ki povezujejo zdravljenje z zdravilom zoledronska kislina, opisane primere hipokalciemije in posledičen razvoj aritmije.
English: 6.6 Special precautions for disposal and other handling Additional information on handling of Zoledronic acid medac 4 mg/100 ml solution for infusion, including guidance on the preparation of reduced doses using the Zoledronic acid medac ready-to-use bottle, is provided in section 4.2.
Slovenian: Nadaljnje informacije o ravnanju z zdravilom Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje, vključno z navodili za pripravo nižjih odmerkov iz plastenke z že pripravljeno raztopino zdravila Zoledronska kislina medac, so navedene v poglavju 4.2.
English: Zoledronic acid medac contains sodium
Slovenian: Zdravilo Zoledronska kislina medac vsebuje natrij
English: Muscle spasms, osteonecrosis of the jaw Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Slovenian: osteonekroza zunanjega slušnega kanala (neželeni učinek skupine difosfonatov) in osteonekroza na drugih anatomskih lokacijah, vključno s stegnenico in kolkom
English: Remove the following amount of Zoledronic acid medac solution for infusion (ml)
Slovenian: Odvzemite navedeni volumen zdravila Zoledronska kislina medac raztopina za infundiranje (ml)
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
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: Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
Slovenian: Zoledronsko kislino 4 mg so proučevali tudi v dvojno slepem, randomiziranem, s placebom kontroliranem preskušanju pri 228 bolnicah z dokazanimi kostnimi zasevki raka dojke, da bi ocenili učinek 4 mg zoledronske kisline na razmerje pogostnosti z okostjem povezanih dogodkov (SRE
English: • Do not use Zoledronic acid medac after the expiry date stated on the vial and carton after EXP.
Slovenian: • Zdravila Zoledronska kislina medac ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake Uporabno do.
English: Statistically significant differences are marked (*p< 0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Slovenian: Povprečne spremembe od izhodišča na BPI lestvici, označene so statistično značilne vrednosti p (*p<0,05) za primerjavo med obema vrstama zdravljenja (4 mg zoledronska kislina v primerjavi s placebom)
English: Prior to administration, 5 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution or 5% w/v glucose solution).
Slovenian: Pred uporabo je treba 5,0 ml koncentrata iz ene viale oziroma ustrezni volumen odvzetega koncentrata dodatno redčiti s 100 ml infuzijske raztopine v kateri ni kalcija (9 mg/ml (0,9-odstotna) raztopina natrijevega klorida ali 5-odstotna m/v raztopina glukoze).
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),
Slovenian: Neželeni učinki so razvrščeni glede na pogostnost, najprej najpogostejši, in to po naslednjem dogovoru: 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: CARTON FOR 4 VIALS
Slovenian: ŠKATLA ZA 1 VIALO ŠKATLA ZA 4 VIALE
English: ≥ 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 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.
English: Table 4: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Slovenian: Preglednica 4: Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate) kateri koli SRE (+TIH) zlomi*
English: Do not mix Zoledronic acid medac with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Slovenian: Ne mešajte zdravila Zoledronska kislina medac z raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata.
English: trembling, tingling or numbness of the hands or feet, diarrhoea, abdominal pain, dry mouth.
Slovenian: mravljinčenje ali odrevenelost rok ali stopal, driska, bolečine v trebuhu, suha usta,
English: The active substance in Zoledronic acid medac is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Slovenian: Kaj je zdravilo Zoledronska kislina medac in za kaj ga uporabljamo Zdravilna učinkovina v zdravilu Zoledronska kislina medac je zoledronska kislina, ki sodi v skupino snovi, ki se imenujejo difosfonati.
English: Table 5: Efficacy results (breast cancer and multiple myeloma patients)
Slovenian: Preglednica 5: Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom)
English: The rate of atrial fibrillation serious adverse events was 1.3 % (51 out of 3,862) and 0.6 % (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Slovenian: Delež atrijske fibrilacije, ki so jo opredelili kot resen neželen dogodek, je bil pri bolnicah, ki so prejemale 5 mg zoledronske kisline, 1,3 % (pri 51 od 3.862 bolnic), pri bolnicah, ki so prejemale placebo, pa 0,6 % (pri 22 od 3.852 bolnic).
English: Table 7: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders Common:
Slovenian: Preglednica 7: Neželeni učinki, ki so jih opažali pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing) Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Slovenian: astenija, periferni edemi, reakcije na mestu injiciranja (vključujoč bolečino, iritacijo, otekanje, zatrdlino), bolečina v prsih, zvečanje telesne mase, anafilaktična reakcija/šok,
English: Multipack: 4 x 1 vial of 5 ml Multipack: 10 x 1 vial of 5 ml
Slovenian: Skupno pakiranje: 4 x 1 viala s 5 ml.
English: Austria medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Slovenian: 2491 Neufeld/Leitha Avstrija medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: LIST OF EXCIPIENTS Excipients: mannitol, sodium citrate, water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: manitol, natrijev citrat, voda za injekcije.
English: Remove the volume of Zoledronic acid medac 4 mg/100 ml solution indicated from the bottle and replace with an equal volume of sterile sodium chloride 9 mg/ml (0.9%) solution for injection, or 5% glucose.
Slovenian: Navedeni volumen raztopine Zoledronska kislina medac 4 mg/100 ml odvzemite iz plastenke in ga nadomestite z enakim volumnom sterilne raztopine natrijevega klorida za injiciranje 9 mg/ml (0,9-odstotne) ali 5-odstotne raztopine glukoze za injiciranje.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/001<1 vial>
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/779/001<1 vial>
English: Pyrexia, fatigue Acute phase reaction, pain
Slovenian: reakcija akutne faze, bolečina
English: Rare (may affect up to 1 in 1,000 people): - As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov): - zaradi nizke vrednosti kalcija: motnje srčnega ritma (aritmija, razvije se zaradi hipokalciemije) - okvara v delovanju ledvic, imenovana Fanconijev sindrom (običajno jo ugotovi zdravnik s pomočjo določenih preiskav urina).
English: Risk reduction of suffering from multiple events**
Slovenian: vrednost p stopnja obolevnosti skeleta vrednost p zmanjšanje tveganja za pojav večkratnih dogodkov** (%)
English: • The readily prepared Zoledronic acid medac infusion solution should preferably be used immediately.
Slovenian: • Razredčeno infuzijsko raztopino zdravila Zoledronska kislina medac morate po možnosti porabiti takoj.
English: What Zoledronic acid medac looks like and contents of the pack Zoledronic acid medac is supplied as solution for infusion in a 100 ml colourless glass bottle (type I) with rubber stoppers (halobutyl, fluoropolymer coated) and aluminium flip-off caps.
Slovenian: Zdravilo Zoledronska kislina medac je v obliki raztopine za infundiranje v 100 ml steklenice, narejeni iz brezbarvnega, prozornega stekla (tipa 1) z gumijastimi zamaški (halobutilna guma, prevlečena s fluoropolimerom) in z aluminijasto odtržno zaporko.
English: Colourless glass bottle type I with fluoropolymer coated halobutyl rubber stopper and aluminium flipoff cap.
Slovenian: Brezbarvna steklenica iz stekla tipa I, zaprti z zamaškom iz halobutilne gume, prevlečene s fluoropolimerom, in z aluminijasto odtržno zaporko.
English: Hypocalcaemia has been reported in patients treated with zoledronic acid.
Slovenian: Pri bolnikih, ki so prejemali zdravilo z zoledronsko kislino, so poročali o hipokalciemiji.
English: Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Slovenian: Spezialpräparate mbH Theaterstr.
English: - Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Slovenian: - reakcije prebavil, na primer slabost s siljenjem na bruhanje (navzea) in bruhanje, pa tudi izguba teka,
English: Zoledronic acid medac 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.
Slovenian: Zdravila Zoledronska kislina medac se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
English: Very rare:
Slovenian: urtikarija redki:
English: This medicinal product 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.
Slovenian: Zdravila ne smemo mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jih je treba dajati kot samostojne intravenske raztopine z ločenim infuzijskim sistemom.
English: Zoledronic acid medac 4mg/5ml concentrate for solution for infusion Sanochemia Pharmazeutika AG
Slovenian: Zoledronska kislina medac 4 mg/5 ml koncentrat za raztopino za infundiranje Sanochemia Pharmazeutika AG
English: Replace with the following volume of sterile sodium chloride 9 mg/ml (0.9%), or 5% glucose solution for injection (ml)
Slovenian: Nadomestite z navedenim volumnom sterilne raztopine natrijevega klorida 9 mg/ml (0,9-odstotne) ali 5-odstotne raztopine glukoze za injiciranje (ml)
English: Very common: Common:
Slovenian: Preiskave zelo pogosti:
English: • Keep Zoledronic acid medac out of the sight and reach of children.
Slovenian: • Zdravilo Zoledronska kislina medac shranjujte nedosegljivo otrokom!
English: Table 1: Preparation of reduced doses of Zoledronic acid medac 4 mg/100 ml solution for infusion
Slovenian: Preglednica 1: Pripravljanje nižjih odmerkov zdravila Zoledronska kislina medac 4 mg/100 ml raztopine za infundiranje
English: • Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil opozorilno kartico za bolnika glede osteonekroze čeljustnic.
English: The withdrawn amount of the concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution or 5% w/v glucose solution.
Slovenian: Odvzeto količino koncentrata morate dodatno redčiti v 100 ml sterilne 9 mg/ml (0,9-odstotne) raztopine natrijevega klorida ali 5
English: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking bisphosphonates, including zoledronic acid.
Slovenian: Iz izkušenj v obdobju trženja pri bolnikih, ki so dobivali difosfonate, vključno z zoledronsko kislino, so poročali o hudih bolečinah v kosteh, sklepih in/ali mišicah.
English: Hypersensitivity reaction Angioneurotic oedema
Slovenian: angionevrotični edem
English: How to store Zoledronic acid medac Contents of the pack and other information
Slovenian: Izgled zdravila Zoledronska kislina medac in vsebina pakiranja
English: PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless solution.
Slovenian: koncentrat za raztopino za infundiranje bistra in brezbarvna raztopina
English: Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with zoledronic acid.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom zoledronska kislina, so poročali o znižani koncentraciji kalcija v krvi (hipokalciemiji), zaradi katere v nekaterih primerih lahko pride do mišičnih krčev, suhe kože in pekočega občutka.
English: LABEL ON MULTIPACKS WITH 4 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Slovenian: NALEPKA NA SKUPNEM PAKIRANJU S 4 STEKLENICAMI, ZAVITIMI V PROZORNO FOLIJO (VKLJUČNO Z BLUE BOX)
English: - are having dental treatment or are due to undergo dental surgery; tell your dentist that you are being treated with Zoledronic acid medac and inform your doctor about your dental treatment.
Slovenian: da se zdravite z zdravilom Zoledronska kislina medac, in obvestite svojega zdravnika o svojem zobozdravstvenem zdravljenju.
English: There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ob uporabi zoledronske kisline v zelo redkih primerih prišlo do dremavosti in zaspanosti.
English: LABEL ON MULTIPACKS WITH 10 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Slovenian: NALEPKA NA SKUPNEM PAKIRANJU Z 10 STEKLENICAMI, ZAVITIMI V PROZORNO FOLIJO (VKLJUČNO Z BLUE BOX)
English: BATCH NUMBER Lot
Slovenian: placebo Δ
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Slovenian: Preglednica 4: Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom) kateri koli SRE (+TIH) zlomi*
English: Zoledronic acid medac is supplied as unit packs containing 1 vial or 4 vials and as multipacks of 4 or 10 cartons each containing 1 vial.
Slovenian: Zdravilo Zoledronska kislina medac je na voljo v posamičnih pakiranjih po 1 vialo ali 4 viale in v večodmernih pakiranjih s 4 ali 10 škatlami, od katerih vsaka vsebuje 1 vialo.
English: What Zoledronic acid medac contains - The active substance is zoledronic acid.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zoledronska kislina medac - Učinkovina je zoledronska kislina.
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Slovenian: Da ne bi prišlo do možnih inkompatibilnosti, mora biti infuzijska raztopina bodisi 9 mg/ml (0,9
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 serumski kreatinin pred vsakim odmerkom zoledronske kisline,
English: Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Slovenian: Analiza večkratnih dogodkov je pokazala za 36 % zmanjšano tveganje za razvoj z okostjem povezanih dogodkov (SRE) v skupini, ki je prejemala zoledronsko kislino 4 mg, v primerjavi s placebom.
English: Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Slovenian: Analiza večkratnih dogodkov je pokazala za 30,7 % zmanjšano tveganje za razvoj z okostjem povezanih dogodkov (SRE) v skupini, ki je prejemala zoledronsko kislino 4 mg, v primerjavi s placebom.
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: 29,8 % v primerjavi s skupino s placebom, kjer je bil 49,6 % (p=0,003).
English: EXP: Read the leaflet for the shelf life of the medicinal product after first opening.
Slovenian: Za datum izteka roka uporabnosti zdravila po prvem odprtju preberite navodila.
English: It is especially important that you tell your doctor if you are also taking: - • Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Slovenian: Posebno pomembno je, da zdravniku poveste, če jemljete tudi naslednja zdravila: - aminoglikozide (zdravila, ki jih uporabljamo za zdravljenje težkih okužb), kalcitonin (vrsta zdravila, ki ga uporabljamo za zdravljenje pri postmenopavzalni osteoporozi in hiperkalciemiji),
English: Zoledronic acid medac is supplied as packs containing 1 bottle or multipacks of 4 or 10 packs each containing 1 bottle.
Slovenian: Zdravilo Zoledronska kislina medac je na voljo v pakiranjih po eno steklenico ali skupno pakiranje po 4 ali 10 škatel s po 1 steklenico.
English: MARKETING AUTHORISATION NUMBER EU/1/12/779/004
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/12/779/004
English: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Slovenian: driska, zapeka, bolečine v trebuhu, dispepsija,
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 2-8°C unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če se zdravilo ne uporabi takoj, je uporabnik odgovoren za trajanje in pogoje shranjevanja pred uporabo, kar ponavadi ne traja dalj kot 24 ur pri temperaturi 2 ºC do 8 ºC, razen če je redčenje potekalo v kontroliranih in validiranih aseptičnih pogojih.
English: How to store Zoledronic acid medac
Slovenian: Shranjevanje zdravila Zoledronska kislina medac
English: Figure 1: Mean changes from baseline in BPI scores.
Slovenian: BPI: povprečne spremembe od izhodišča
English: Within three days after zoledronic acid administration, an acute phase reaction has been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Slovenian: So poročali o reakciji akutne faze, do katere pride v prvih treh dneh po vnosu zoledronske kisline, simptomi pa vključujejo bolečine v kosteh, zvišano telesno temperaturo, utrujenost, artralgijo, mialgijo, okorelost in artritis, ki povzroči otekline sklepov.