natgillin/translations-raw huggingface dataset:
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS The veterinary medicinal product is a white to off-white suspension for use in drinking water containing 200 mg/ml of fenbendazole and 20 mg/ml of benzyl alcohol (E1519). 
ki vsebuje 200 mg/ml fenbendazola in 20 mg/ml benzilalkohola (E1519).
Ascaridia galli and Heterakis gallinarum: 1 mg fenbendazole per kg body weight per day (equivalent to 0.005 ml Panacur AquaSol) for 5 consecutive days. 
Ascaridia galli in Heterakis gallinarum: Odmerek 1 mg fenbendazola na kg telesne mase na dan
Pigs: 
KARENCA(E) Prašiči:
HDPE container with pulp board/aluminium/polyester/MDPE seal closed with child-resistant polypropylene screw cap. 
HDPE vsebnik z otrokom varno zaporko z navojem s folijo za induktivno varjenje, material MDPE
Treatment and control of gastro-intestinal nematodes in pigs infected with: - Ascaris suum (adult, intestinal and migrating larval stages) - Oesophagostomum spp. 
- Ascaris suum (odrasli, intestinalni in migrirajoči larvalni stadiji)
400 ml 1600 ml 
1.600 ml
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani
Liver Kidney Milk Eggs 
Živalska vrsta MRL Ciljna tkiva
ADVERSE REACTIONS None known. 
NEŽELENI UČINKI
• At the request of the European Medicines Agency, 
• na zahtevo Evropske agencije za zdravila,
10 000 Zagreb Croatia 
10 000 Zagreb
Any SRE (+TIH) 
kateri koli SRE (+TIH)
Adults and elderly people 
Odrasli in starejši ljudje
(See Annex I: Summary of Product Characteristics, section 4.2) 
(Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
EU/1/12/771/001 1 plastic vial EU/1/12/771/002 4 plastic vials EU/1/12/771/003 10 plastic vials EU/1/12/771/004 1 glass vial EU/1/12/771/005 4 glass vials EU/1/12/771/006 10 glass vials 
EU/1/12/771/001 1 plastična viala EU/1/12/771/002 4 plastične viale EU/1/12/771/003 10 plastičnih vial EU/1/12/771/004 1 steklena viala EU/1/12/771/005 4 steklene viale EU/1/12/771/006 10 steklenih vial
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 August 2012 
Datum prve odobritve: 16. avgust 2012
In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days). 
V večini primerov ni potrebno nikakršno specifično zdravljenje in simptomi v kratkem (čez nekaj ur ali dni)
Date of latest renewal: 22 May 2017 
Datum zadnjega podaljšanja: 22. maj 2017 10.
Do not throw away any medicines via wastewater (or household waste). 
Zdravila ne smete odvreči v odpadne vode (ali med gospodinjske odpadke).
- Low blood pressure. 
- nizek krvni tlak,
- 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.
If any of these apply to you, tell your doctor straight away. 
Če se pri vas razvije kar koli od navedenega, takoj obvestite svojega zdravnika.
1.0 mg/dl or 88 μmol/l. 
1,0 mg/dl ali 88 μmol/l.
Pack sizes of 1, 4 or 10 vials. 
Pakiranja po 1, 4 ali 10 vial.
MARKETING AUTHORISATION NUMBER(S) EU/1/12/771/001-006 
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/12/771/001-006
- Confusion. 
- zmedenost,
After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and 25°C. 
Po redčenju: Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 2 °C8 °C in 25 °C.
− 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).
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight. 
5,04 ± 2,5 l/h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa in telesna masa.
If a lower dose of zoledronic acid 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 zoledronske kisline, najprej odvzemite ustrezni volumen, kot je navedeno spodaj, in ga nato dodatno razredčite s 100 ml infuzijske raztopine.
Zoledronic Acid Teva can be given to people aged 65 years and over. 
Zdravilo Zoledronska kislina Teva lahko dajemo ljudem, ki so stari 65 let ali več.
Additional information on handling on Zoledronic Acid Teva, including guidance on preparation of reduced doses, is provided in section 4.2. 
Nadaljnje informacije o ravnanju z zdravilom Zoledronska kislina Teva, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.
• To reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour. 
- zniževanje količine kalcija v krvi pri odraslih, kadar je ta prevelika zaradi prisotnosti tumorja.
* 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 
** velja za vse skeletne dogodke, tako za njihovo celotno število kot za trajanje vsakega dogodka med preskušanjem NR ni bil dosežen
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: 
Hrvaška Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
- Urticaria. 
- koprivnica.
- if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which zoledronic acid belongs), or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na zoledronsko kislino, kak drug difosfonat (skupina snovi, ki ji pripada zoledronska kislina) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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
- If you are being treated to reduce the amount of calcium in your blood, you will normally only be given a single infusion of Zoledronic Acid Teva. 
- Če prejemate zdravilo za zniževanje količine kalcija v krvi, boste običajno prejeli samo eno infuzijo zdravila Zoledronska kislina Teva.
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. 
Hrvaška V natisnjenem navodilu morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
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 Teva 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 Teva potrebna previdnost pri vožnji in upravljanju s stroji.
Prilaz baruna Filipovića 25 
PLIVA Croatia Ltd Prilaz baruna Filipovića 25
Arthritis and joint swelling as a symptom of acute phase reaction 
urtikarija artritis in otekline sklepov kot simptoma reakcije akutne faze
How much Zoledronic Acid Teva is given - The usual single dose given is 4 mg. - If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem. 
Koliko zdravila Zoledronska kislina Teva se daje - Običajni posamezni odmerek je 4 mg. - Če imate težave z ledvicami, vam bo zdravnik dal manjši odmerek, ki bo odvisen od tega, kako hude so vaše težave z ledvicami.
METHOD OF ADMINISTRATION Dilute before use. 
POSTOPEK UPORABE Pred uporabo razredčiti.
How often Zoledronic Acid Teva is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic Acid Teva every three to four weeks. 
Kako pogosto se daje zdravilo Zoledronska kislina Teva - Če prejemate zdravilo za preprečevanje zapletov na kosteh zaradi kostnih metastaz, boste prejeli eno infuzijo zdravila Zoledronska kislina Teva vsake tri do štiri tedne.
The total time between dilution, storage in a refrigerator at 2°C - 8°C and end of administration must not exceed 24 hours. 
Celoten čas med razredčitvijo, shranjevanjem v hladilniku pri 2 °C - 8 °C, ter koncem infuzije ne sme presegati 24 ur.
- Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with zoledronic acid. 
- Študije z več vrstami infuzijskih sistemov, izdelanih iz polivinilklorida, polietilena in polipropilena, niso pokazale nezdružljivosti z zdravilom Zoledronska kislina Teva.
1Adverse 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). 
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).
Other medicines and Zoledronic Acid Teva Tell your doctorif you are taking, have recently taken or might take any other medicines. 
Druga zdravila in zdravilo Zoledronska kislina Teva Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
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 obveze za predložitev rezultatov študij referenčnega zdravila, 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).
Zoledronic Acid Teva 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. 
Zdravila Zoledronska kislina Teva ne priporočajo bolnikom, ki imajo že pred uvedbo zdravljenja težko ledvično okvaro, ki je za to skupino bolnikov opredeljena kot CLcr < 30 ml/min.
Each vial contains 5 ml of concentrate. 
Ena viala vsebuje 5 ml koncentrata.
Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) 
Preglednica 2: Rezultati učinkovitosti (bolniki z rakom prostate, ki so prejemali hormonsko zdravljenje)
The active substance in this medicine is zoledronic acid, which belongs to a group of substances called bisphosphonates. 
Zdravilna učinkovina v zdravilu je zoledronska kislina, ki sodi v skupino snovi, ki se imenujejo difosfonati.
Zoledronic Acid Teva is supplied as packs containing 1, 4 or 10 vials. 
Zdravilo Zoledronska kislina Teva je na voljo v pakiranju po 1, 4 ali 10 vial.
- 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.
Cyclic Olefin Polymer (COP) plastic vial or clear glass vial (type I) with chlorobutyl/butyl flurotec stopper and aluminium cap with plastic flip-off cap. 
Plastična viala iz cikloolefinskega polimera (COP) ali prozorna steklena viala (tipa I) z zamaškom iz klorobutil/butil Flurotec in aluminijasto zaporko s plastično snemno zaporko.
After initiating the infusion of zoledronic acid, the plasma concentrations of zoledronic acid rapidly increased, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak prior to the second infusion of zoledronic acid on day 28. 
Po začetku infuzije zoledronske kisline so se plazemske koncentracije zoledronske kisline hitro zvišale, dosegle ob koncu obdobja infuzije vrh, ki mu je sledilo hitro znižanje na < 10 % najvišje koncentracije po 4 urah in na < 1 % najvišje koncentracije po 24 urah, čemur je sledilo dolgotrajno obdobje zelo nizkih koncentracij, ki pred drugo infuzijo zoledronske kisline na 28. dan niso presegle
Single and multiple 5- and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients with bone metastases yielded the following pharmacokinetic data, which were found to be dose independent. 
Pri posameznih in večkratnih 5-minutnih in 15-minutnih infuzijah 2, 4, 8 in 16 mg zoledronske kisline pri 64 bolnikih z zasevki v kosteh so dobili spodnje farmakokinetične podatke, za katere so ugotovili,
Each plastic or clear glass vial contains 5 ml of a clear, colourless concentrate. 
Ena plastična ali prozorna steklena viala vsebuje 5 ml bistrega brezbarvnega koncentrata.
While being treated with Zoledronic Acid Teva, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. 
V času zdravljenja z zdravilom Zoledronska kislina Teva morate skrbeti za dobro ustno higieno (kar vključuje redno čiščenje zob) in redno hoditi na rutinske preglede k zobozdravniku.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06-0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose. 
Varno območje, glede na učinke na ledvici, je bilo v dolgoročnih študijah večkratnih parenteralnih odmerkov na živalih ozko, vendar kumulativne koncentracije brez neželenih učinkov (NOAEL) pri enkratnih odmerkih (1,6 mg/kg) in pri do en mesec trajajočih študijah večkratnih odmerkov (0,06-0,6 mg/kg/dan) niso kazale na učinke na ledvici v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
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 t½α 0,24 ure in t½β 1,87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t½γ 146 ur.
Proportion of patients with SREs (%) p-value 
delež bolnic/bolnikov s SREs (%) vrednost p mediana časa do SRE
For instructions of the dilution of the medicinal product before administration, see section 6.6. 
Za navodila glede redčenja zdravila pred dajanjem glejte poglavje 6.6.
- For single use only. 
Samo za enkratno uporabo.
- 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. 
- če imate (ali ste imeli kdaj prej) bolečino, oteklino ali občutek odrevenelosti v čeljusti, če čutite težo v čeljusti ali se vam maje zob.
Following initiation of therapy, serum creatinine should be measured prior to each dose of Zoledronic Acid Teva and treatment should be withheld if renal function has deteriorated. 
Po uvedbi terapije je treba izmeriti serumski kreatinin pred vsakim odmerkom zdravila Zoledronska kislina Teva, terapijo pa je treba prekiniti, če se je ledvična funkcija poslabšala.
Zoledronic Acid Teva 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 Teva pri bolnikih s TIH, ki imajo tudi težko ledvično okvaro, lahko pride v poštev šele po oceni nevarnosti in koristnih učinkov zdravljenja.
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). 
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).
Please see below for maximum in-use storage time. 
Za informacije najdaljšega shranjevanja pripravljene raztopine glejte spodaj.
Zoledronic acid Teva 4 mg/5 ml 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 Teva 4 mg/5 ml 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.
The other ingredients are: mannitol, sodium citrate and water for injections. 
- Druge sestavine so: manitol, natrijev citrat in voda za injekcije.
Zoledronic acid was teratogenic in the rat at subcutaneous doses ≥ 0.2 mg/kg. 
Zoledronska kislina je bila teratogena pri podganah pri subkutanih odmerkih ≥ 0,2 mg/kg.
In the zoledronic acid-treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1). 
V skupini, zdravljeni z zoledronsko kislino, so opažali statistično značilno izboljšanje na bolečinski lestvici (uporabili so Brief Pain Inventory, BPI) po 4 tednih in ob vseh nadaljnjih časovnih točkah primerjave s placebom v študiji (slika 1).
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). 
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).
- The total time between dilution, storage in the refrigerator and end of administration must not exceed 24 hours. 
- Celoten čas med razredčitvijo, shranjevanjem v hladilniku ter koncem infuzije ne sme presegati
The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/min. 
Pričakuje se, da bodo zmanjšani odmerki pri bolnikih z ledvičnimi okvarami dosegli iste AUC, kot jih vidimo pri bolnikih z očistkom kreatinina
If the solution is not used immediately, storage prior to use is the responsibility of the user and should be in a refrigerator at 2°C - 8°C. 
Če zdravstveni delavec raztopine ne uporabi takoj, je sam odgovoren za trajanje in pogoje shranjevanja pred uporabo, raztopina mora biti shranjena v hladilniku pri 2 °C - 8 °C.
− 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.
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 Teva 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 zdravila Zoledronska kislina Teva pri bolnikih s težko ledvično okvaro ne priporočamo.
- Low level of red blood cells (anaemia). 
- nizka koncentracija rdečih krvnih celic (anemija), - konjuktivitis (vnetje očesne veznice).
When initiating treatment with Zoledronic Acid Teva in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined. 
Pri uvajanju zdravljenja z zdravilom Zoledronska kislina Teva pri bolnikih z multiplim mielomom ali metastatičnimi kostnimi lezijami zaradi čvrstih tumorjev je treba določiti serumski kreatinin in očistek kreatinina (CLcr).
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid Teva. 
Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zdravila Zoledronska kislina Teva.
• To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone). 
- preprečevanje zapletov na kosteh, na primer zlomov, pri odraslih bolnikih z metastazami v kosteh (z razširitvijo raka s prvotnega mesta na kosti),
10 x 5 ml vials 
10 x 5 ml vial
- Since no data are available on the compatibility of zoledronic acid with other intravenously administered substances, zoledronic acid must not be mixed with other medicinal products/substances and should always be given through a separate infusion line. 
- Ker o združljivosti zoledronske kisline z drugimi intravensko dajanimi snovmi ni na voljo nikakršnih podatkov, zoledronske kisline ne smete mešati z drugimi zdravili ali snovmi in jo moramo vedno dajati po ločenem infuzijskem sistemu.
- In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer medicinal products, 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,
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. 
Če ga uporabnik ne uporabi takoj, je sam odgovoren za čas in pogoje shranjevanja pred uporabo.
Placebo Δ Zoledronic acid  
Placebo Δ Zoledronska kislina 
Marketing Authorisation Holder Teva B.V. 
Imetnik dovoljenja za promet Teva B.V.
For single use only. 
samo za enkratno uporabo
Table 1 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). 
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).
Zoledronic Acid Teva should not be used during pregnancy. 
Zdravila Zoledronska kislina Teva ne smete uporabljati med nosečnostjo.
Hypocalcaemia is an important identified risk with Zoledronic Acid Teva in the approved indications. 
Hipokalciemija predstavlja pomembno tveganje, ki ga opažajo pri uporabi zdravila Zoledronska kislina Teva za odobrene indikacije.