natgillin/translations-raw huggingface dataset:
Table 7: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders Common: 
Preglednica 7: Neželeni učinki, ki so jih opažali pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta
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 
astenija, periferni edemi, reakcije na mestu injiciranja (vključujoč bolečino, iritacijo, otekanje, zatrdlino), bolečina v prsih, zvečanje telesne mase, anafilaktična reakcija/šok,
Multipack: 4 x 1 vial of 5 ml Multipack: 10 x 1 vial of 5 ml 
Skupno pakiranje: 4 x 1 viala s 5 ml.
Austria medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 
2491 Neufeld/Leitha Avstrija medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
LIST OF EXCIPIENTS Excipients: mannitol, sodium citrate, water for injections. 
SEZNAM POMOŽNIH SNOVI Pomožne snovi: manitol, natrijev citrat, voda za injekcije.
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. 
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.
MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/001<1 vial> 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/779/001<1 vial>
Pyrexia, fatigue Acute phase reaction, pain 
reakcija akutne faze, bolečina
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). 
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).
Risk reduction of suffering from multiple events** 
vrednost p stopnja obolevnosti skeleta vrednost p zmanjšanje tveganja za pojav večkratnih dogodkov** (%)
• The readily prepared Zoledronic acid medac infusion solution should preferably be used immediately. 
• Razredčeno infuzijsko raztopino zdravila Zoledronska kislina medac morate po možnosti porabiti takoj.
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. 
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.
Colourless glass bottle type I with fluoropolymer coated halobutyl rubber stopper and aluminium flipoff cap. 
Brezbarvna steklenica iz stekla tipa I, zaprti z zamaškom iz halobutilne gume, prevlečene s fluoropolimerom, in z aluminijasto odtržno zaporko.
Hypocalcaemia has been reported in patients treated with zoledronic acid. 
Pri bolnikih, ki so prejemali zdravilo z zoledronsko kislino, so poročali o hipokalciemiji.
- Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite. 
- reakcije prebavil, na primer slabost s siljenjem na bruhanje (navzea) in bruhanje, pa tudi izguba teka,
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. 
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.
Very rare: 
urtikarija redki:
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. 
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.
Zoledronic acid medac 4mg/5ml concentrate for solution for infusion Sanochemia Pharmazeutika AG 
Zoledronska kislina medac 4 mg/5 ml koncentrat za raztopino za infundiranje Sanochemia Pharmazeutika AG
Replace with the following volume of sterile sodium chloride 9 mg/ml (0.9%), or 5% glucose solution for injection (ml) 
Nadomestite z navedenim volumnom sterilne raztopine natrijevega klorida 9 mg/ml (0,9-odstotne) ali 5-odstotne raztopine glukoze za injiciranje (ml)
Very common: Common: 
Preiskave zelo pogosti:
• Keep Zoledronic acid medac out of the sight and reach of children. 
• Zdravilo Zoledronska kislina medac shranjujte nedosegljivo otrokom!
Table 1: Preparation of reduced doses of Zoledronic acid medac 4 mg/100 ml solution for infusion 
Preglednica 1: Pripravljanje nižjih odmerkov zdravila Zoledronska kislina medac 4 mg/100 ml raztopine za infundiranje
• Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented. 
Imetnik dovoljenja za promet z zdravilom bo zagotovil opozorilno kartico za bolnika glede osteonekroze čeljustnic.
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. 
Odvzeto količino koncentrata morate dodatno redčiti v 100 ml sterilne 9 mg/ml (0,9-odstotne) raztopine natrijevega klorida ali 5
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking bisphosphonates, including zoledronic acid. 
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.
Hypersensitivity reaction Angioneurotic oedema 
angionevrotični edem
How to store Zoledronic acid medac Contents of the pack and other information 
Izgled zdravila Zoledronska kislina medac in vsebina pakiranja
PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless solution. 
koncentrat za raztopino za infundiranje bistra in brezbarvna raztopina
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. 
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.
LABEL ON MULTIPACKS WITH 4 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX) 
NALEPKA NA SKUPNEM PAKIRANJU S 4 STEKLENICAMI, ZAVITIMI V PROZORNO FOLIJO (VKLJUČNO Z BLUE BOX)
- 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. 
da se zdravite z zdravilom Zoledronska kislina medac, in obvestite svojega zdravnika o svojem zobozdravstvenem zdravljenju.
There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid. 
Vpliv na sposobnost upravljanja vozil in strojev Ob uporabi zoledronske kisline v zelo redkih primerih prišlo do dremavosti in zaspanosti.
LABEL ON MULTIPACKS WITH 10 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX) 
NALEPKA NA SKUPNEM PAKIRANJU Z 10 STEKLENICAMI, ZAVITIMI V PROZORNO FOLIJO (VKLJUČNO Z BLUE BOX)
BATCH NUMBER Lot 
placebo Δ
Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH) 
Preglednica 4: Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom) kateri koli SRE (+TIH) zlomi*
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. 
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.
What Zoledronic acid medac contains - The active substance is zoledronic acid. 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zoledronska kislina medac - Učinkovina je zoledronska kislina.
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. 
Da ne bi prišlo do možnih inkompatibilnosti, mora biti infuzijska raztopina bodisi 9 mg/ml (0,9
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. 
Po uvedbi terapije je treba izmeriti serumski kreatinin pred vsakim odmerkom zoledronske kisline,
Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo. 
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.
Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo. 
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.
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). 
29,8 % v primerjavi s skupino s placebom, kjer je bil 49,6 % (p=0,003).
EXP: Read the leaflet for the shelf life of the medicinal product after first opening. 
Za datum izteka roka uporabnosti zdravila po prvem odprtju preberite navodila.
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. 
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),
Zoledronic acid medac is supplied as packs containing 1 bottle or multipacks of 4 or 10 packs each containing 1 bottle. 
Zdravilo Zoledronska kislina medac je na voljo v pakiranjih po eno steklenico ali skupno pakiranje po 4 ali 10 škatel s po 1 steklenico.
MARKETING AUTHORISATION NUMBER EU/1/12/779/004 
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/12/779/004
Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth 
driska, zapeka, bolečine v trebuhu, dispepsija,
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. 
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.
How to store Zoledronic acid medac 
Shranjevanje zdravila Zoledronska kislina medac
Figure 1: Mean changes from baseline in BPI scores. 
BPI: povprečne spremembe od izhodišča
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). 
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.
Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients versus 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) versus 41% (31/76). 
O zlomih dolgih kosti spodnjih okončin so pri bolnikih s hudo obliko osteogenesis imperfecta, ki so prejemali zoledronsko kislino, poročali v približno 24 % (zlom stegnenice) in v 14 % (zlom golenice) v primerjavi z enakovrednimi bolniki, ki so prejemali pamidronat, pri katerih so o zlomu stegnenice poročali v 12 %, o zlomu golenice pa v 5 %.
Placebo Zoledronic acid 4 mg 
4 mg placebo zoledronska kislina
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. 
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.
- if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which 
Zdravila Zoledronska kislina medac ne smete dobiti: - če dojite, - če ste alergični na zoledronsko kislino, kak drug difosfonat (skupina snovi, ki ji pripada zdravilo
Table 3: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH) 
Preglednica 3: Rezultati učinkovitosti (bolniki z rakom prostate, ki so prejemali hormonsko zdravljenje)
- High blood pressure, shortness of breath, dizziness, sleep disturbances, taste disturbances, 
- bolečina v prsih, - kožne reakcije (rdečina in otekanje) na mestu infuzije, izpuščaj, srbenje, - visok krvni tlak, zadihanost, omotičnost, motnje spanja, motnje okušanja, tresenje,
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
QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle with 100 ml solution contains 4 mg zoledronic acid (as monohydrate). 
Ena plastenka s 100 ml raztopine vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
How Zoledronic acid medac is used 
Kako se zdravilo Zoledronska kislina medac daje
- Weight increase. 
- Navodilo shranite.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/100 ml solution for infusion Zoledronic acid 
Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje zoledronska kislina
You must not be given Zoledronic acid medac if you are breast-feeding. 
Če dojite, vam ne smejo dati zdravila Zoledronska kislina medac.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/100 ml solution for infusion 
Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje
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. 
diuretike Henlejeve zanke (vrsta zdravila za zdravljenje visokega krvnega tlaka ali otekanja) ali druga zdravila, ki znižujejo koncentracijo kalcija, ker kombinacija le-teh z difosfonati lahko preveč zniža koncentracijo kalcija v krvi, - talidomid (zdravilo, ki ga uporabljamo pri zdravljenju določenih vrst krvnega raka, ki zajemajo kosti) ali druga zdravila, ki lahko škodujejo ledvicam,
• Zoledronic acid medac 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function. 
• Za bolnike z normalnim delovanjem ledvic je zdravilo Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje mogoče uporabiti takoj brez dodatne priprave.
You should not be given Zoledronic acid medac if you are pregnant. 
Če ste noseči, vam ne bi smeli dati zdravila Zoledronska kislina medac.
Zoledronic acid medac must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. 
Zdravilo Zoledronska kislina medac smejo predpisovati in dajati bolnikom samo zdravstveni delavci,
NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion 
Zoledronska kislina medac 4 mg/5 ml koncentrat za raztopino za infundiranje
PHARMACEUTICAL FORM Solution for infusion Clear, colourless solution. 
raztopina za infundiranje bistra in brezbarvna raztopina
3.5 mg* 
4,0 mg 3,5 mg* 3,3 mg* 3,0 mg*
MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/005 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/779/005
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as Zoledronic acid medac (see section 4.4). 
Predvsem pri bolnikih z rakom, zdravljenih z zdravili, ki zavirajo resorpcijo kosti, kot je zdravilo
1 bottle of 100 ml. 
1 steklenica s 100 ml. Del skupnega pakiranja.
Very common (may affect more than 1 in 10 people): - Low level of phosphate in the blood. 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic acid medac 4 mg/5 ml sterile concentrate Intravenous use. 
Zoledronska kislina medac 4 mg/5 ml sterilni koncentrat intravenska uporaba
Episcleritis 
uveitis episkleritis
Table 3: Efficacy results (solid tumours other than breast or prostate cancer) 
Preglednica 3: Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate) kateri koli SRE (+TIH) zlomi*
NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion Zoledronic acid 
Zoledronska kislina medac 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
Each vial contains 100 ml of solution 
Ena viala vsebuje 100 ml koncentrata.
Uncommon: Very rare: 
preobčutljivostna reakcija redki:
- Increased sweating. 
- zvečanje telesne mase, - zvečano znojenje,
Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic acid medac. 
O teh primerih so poročali predvsem pri odraslih bolnikih z rakom, ki so se zdravili z zdravilom Zoledronska kislina medac.
Common: Uncommon: 
konjunktivitis občasni:
MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/002 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/779/002
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid medac or after stopping treatment. 
Če pride do takih simptomov med zdravljenjem ali po prenehanju zdravljenja z zdravilom Zoledronska kislina medac, takoj obvestite svojega zdravnika in zobozdravnika.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL ON MULTIPACKS WITH 4 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX) 
NALEPKA NA SKUPNEM PAKIRANJU S 4 VIALAMI, OVITIMI V PROZORNO FOLIJO (Z BLUE BOX)
LABEL ON MULTIPACKS WITH 10 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX) 
NALEPKA NA SKUPNEM PAKIRANJU Z 10 VIALAMI, OVITIMI V PROZORNO FOLIJO (Z BLUE BOX)
This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment. 
Če ste prejeli večji odmerek zdravila Zoledronska kislina medac, kot bi smeli Če ste prejeli odmerek, ki je večji od priporočenega, vas mora zdravnik natančno nadzorovati, zato ker lahko pride do nepravilnosti elektrolitov v serumu (do nepravilnih koncentracij kalcija, fosforja in magnezija) in/ali do spremenjenega delovanja ledvic, vključno z ledvično odpovedjo.
MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/004 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/779/004
Uveitis 
zmedenost
- Blurred vision, tearing of the eye, eye sensitivity to light. 
- zamegljen vid, solzenje oči, občutljivost oči na svetlobo, - nenaden občutek hladu z izgubo zavesti, mlahavost ali kolaps (padec zaradi nenadnega znižanja krvnega tlaka),
Package leaflet: Information for the user Zoledronic acid medac 4 mg/100 ml solution for infusion Zoledronic acid 
Navodilo za uporabo Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje zoledronska kislina
Grounds for the variation to the terms of the marketing authorisation(s) 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Package leaflet: Information for the user Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion Zoledronic acid 
Navodilo za uporabo Zoledronska kislina medac 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
Zoledronic acid medac 4mg/100ml solution for infusion medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 
IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje medac Gesellschaft für klinische Spezialpräparate mbH
SPECIAL STORAGE CONDITIONS Do not freeze. 
POSEBNA NAVODILA ZA SHRANJEVANJE
In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following zoledronic acid dose is recommended (see also section 4.4): 
(opredeljeno za to skupino bolnikov kot CLcr 30-60 ml/min), priporočajo naslednji odmerek zoledronske kisline (glejte tudi poglavje 4.4):
STATEMENT OF ACTIVE SUBSTANCE(S) One bottle contains 4 mg of zoledronic acid (as monohydrate). 
Ena steklenica vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg of zoledronic acid (as monohydrate). 
Ena viala vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
How to prepare and administer Zoledronic acid medac 
Kako zdravilo Zoledronska kislina medac pripravljate in dajete
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI NALEPKA STEKLENICE
If you are given more Zoledronic acid medac than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor. 
Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina medac Skrbno se ravnajte po vseh navodilih, ki vam jih je dal vaš zdravnik.
It is available as chewable tablets (2.5 mg/20 mg, 5 mg/40 mg and 10 mg/80 mg). 
Na voljo je v obliki žvečljivih tablet (2,5 mg/20 mg, 5 mg/40 mg in 10 mg/80 mg).
The European Commission granted a marketing authorisation valid throughout the European Union, for Cardalis on 23 July 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Cardalis, veljavno po vsej Evropski uniji, odobrila dne 23. julija 2012.