natgillin/translations-raw huggingface dataset:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka filmsko obložena tableta vsebuje 150 mg irbesartana.
The efficacy of Irbesartan BMS is not influenced by age or gender. 
Spol in starost ne vplivata na učinkovitost zdravila Irbesartan BMS.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg film-coated tablets. 
IME ZDRAVILA Irbesartan BMS 300 mg filmsko obložene tablete.
Irbesartan BMS 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Irbesartan BMS 75 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg tablets irbesartan 
IME ZDRAVILA Irbesartan BMS 300 mg tablete irbesartan
Cartons of 84 film-coated tablets: 6 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters. 
Škatle s 84 filmsko obloženimi tabletami: 6 pretisnih omotov iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Cartons of 98 tablets: 7 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters. 
Škatle z 98 tabletami: 7 pretisnih omotov iz PVC/PVDC/aluminija s 14 tabletami.
Irbesartan BMS 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Irbesartan BMS 300 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Cartons of 56 tablets: 4 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters. 
Škatle z 56 tabletami: 4 pretisni omoti iz PVC/PVDC/aluminija s 14 tabletami.
Irbesartan BMS 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Irbesartan BMS 150 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Cartons of 14 tablets: 1 blister card of 14 tablets in PVC/PVDC/Aluminium blisters. 
Škatle s 14 tabletami: 1 pretisni omot iz PVC/PVDC/aluminija s 14 tabletami.
Cartons of 28 tablets: 2 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters. 
Škatle z 28 tabletami: 2 pretisna omota iz PVC/PVDC/aluminija s 14 tabletami.
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease. 
Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (štiri tablete) enkrat na dan.
Cartons of 28 film-coated tablets: 2 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters. 
Škatle z 28 filmsko obloženimi tabletami: 2 pretisna omota iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Cartons of 56 film-coated tablets: 4 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters. 
Škatle s 56 filmsko obloženimi tabletami: 4 pretisni omoti iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Irbesartan BMS 300 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets. 
Irbesartan BMS 300 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
Irbesartan BMS is used to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function. 
za zaščito ledvic pri bolnikih z visokim krvnim tlakom, ki imajo sladkorno bolezen tipa 2 in laboratorijsko potrjeno okvaro delovanja ledvic.
Irbesartan BMS 150 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets. 
Irbesartan BMS 150 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
Cartons of 98 film-coated tablets: 7 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters. 
Škatle z 98 filmsko obloženimi tabletami: 7 pretisnih omotov iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Irbesartan BMS 75 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets. 
Irbesartan BMS 75 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough 
Bolezni dihal, prsnega koša in mediastinalnega prostora: Občasni:
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg tablets. 
IME ZDRAVILA Irbesartan BMS 75 mg tablete
Cartons of 14 film-coated tablets: 1 blister card of 14 film-coated tablets in PVC/PVDC/Aluminium blisters. 
Škatle s 14 filmsko obloženimi tabletami: 1 pretisni omot iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg film-coated tablets irbesartan 
Irbesartan BMS 75 mg filmsko obložene tablete irbesartan
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease. 
Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg enkrat na dan.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side. 
Izgled zdravila Irbesartan BMS in vsebina pakiranja Irbesartan BMS 75 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
EU/1/06/375/011 - 14 tablets EU/1/06/375/012 - 28 tablets EU/1/06/375/013 - 56 tablets EU/1/06/375/014 - 56 x 1 tablets EU/1/06/375/015 - 98 tablets 
EU/1/06/375/011 - 14 tablet EU/1/06/375/012 - 28 tablet EU/1/06/375/013 - 56 tablet EU/1/06/375/014 - 56 x 1 tablet EU/1/06/375/015 - 98 tablet
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg tablets. 
IME ZDRAVILA Irbesartan BMS 150 mg tablete
EU/1/06/375/016 - 14 tablets EU/1/06/375/017 - 28 tablets EU/1/06/375/018 - 56 tablets EU/1/06/375/019 - 56 x 1 tablets EU/1/06/375/020 - 84 tablets EU/1/06/375/021 - 98 tablets 
EU/1/06/375/016 - 14 tablet EU/1/06/375/017 - 28 tablet EU/1/06/375/018 - 56 tablet EU/1/06/375/019 - 56 x 1 tablet EU/1/06/375/020 - 84 tablet EU/1/06/375/021 - 98 tablet
EU/1/06/375/022 - 14 tablets EU/1/06/375/023 - 28 tablets EU/1/06/375/024 - 56 tablets EU/1/06/375/025 - 56 x 1 tablets EU/1/06/375/026 - 84 tablets EU/1/06/375/027 - 98 tablets 
EU/1/06/375/022 - 14 tablet EU/1/06/375/023 - 28 tablet EU/1/06/375/024 - 56 tablet EU/1/06/375/025 - 56 x 1 tablet EU/1/06/375/026 - 84 tablet EU/1/06/375/027 - 98 tablet
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg film-coated tablets irbesartan 
Irbesartan BMS 150 mg filmsko obložene tablete irbesartan
EU/1/06/375/006 - 14 tablets EU/1/06/375/007 - 28 tablets EU/1/06/375/008 - 56 tablets EU/1/06/375/009 - 56 x 1 tablets EU/1/06/375/010 - 98 tablets 
EU/1/06/375/006 - 14 tablet EU/1/06/375/007 - 28 tablet EU/1/06/375/008 - 56 tablet EU/1/06/375/009 - 56 x 1 tablet EU/1/06/375/010 - 98 tablet
EU/1/06/375/028 - 14 tablets EU/1/06/375/029 - 28 tablets EU/1/06/375/030 - 56 tablets EU/1/06/375/031 - 56 x 1 tablets EU/1/06/375/032 - 84 tablets EU/1/06/375/033 - 98 tablets 
EU/1/06/375/028 - 14 tablet EU/1/06/375/029 - 28 tablet EU/1/06/375/030 - 56 tablet EU/1/06/375/031 - 56 x 1 tablet EU/1/06/375/032 - 84 tablet EU/1/06/375/033 - 98 tablet
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg film-coated tablets irbesartan 
Irbesartan BMS 300 mg filmsko obložene tablete irbesartan
EU/1/06/375/001 - 14 tablets EU/1/06/375/002 - 28 tablets EU/1/06/375/003 - 56 tablets EU/1/06/375/004 - 56 x 1 tablets EU/1/06/375/005 - 98 tablets 
EU/1/06/375/001 - 14 tablet EU/1/06/375/002 - 28 tablet EU/1/06/375/003 - 56 tablet EU/1/06/375/004 - 56 x 1 tablet EU/1/06/375/005 - 98 tablet
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side. 
Izgled zdravila Irbesartan BMS in vsebina pakiranja Irbesartan BMS 75 mg tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side. 
Izgled zdravila Irbesartan BMS in vsebina pakiranja Irbesartan BMS 150 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg tablets. 
IME ZDRAVILA Irbesartan BMS 300 mg tablete
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 75 mg film-coated tablets irbesartan 
NAVODILO ZA UPORABO Irbesartan BMS 75 mg filmsko obložene tablete irbesartan
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 75 mg tablets irbesartan 
NAVODILO ZA UPORABO Irbesartan BMS 75 mg tablete irbesartan
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 150 mg film-coated tablets irbesartan 
NAVODILO ZA UPORABO Irbesartan BMS 150 mg filmsko obložene tablete irbesartan
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side. 
Izgled zdravila Irbesartan BMS in vsebina pakiranja Irbesartan BMS 300 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 300 mg film-coated tablets irbesartan 
NAVODILO ZA UPORABO Irbesartan BMS 300 mg filmsko obložene tablete irbesartan
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side. 
Izgled zdravila Irbesartan BMS in vsebina pakiranja Irbesartan BMS 150 mg tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 150 mg tablets irbesartan 
NAVODILO ZA UPORABO Irbesartan BMS 150 mg tablete irbesartan
MA (EU) number (Invented) name 
Številka( EU) dovoljenja za promet
Strength Pharmaceutical Form Route of Administration Immediate Packaging 
Zrnca za peroralno suspenzijo Peroralna uporaba
Protection starts from 25 days after the last injection and lasts for at least a year. 
Zaščita je učinkovita od 25. dne po zadnji injekciji in traja vsaj eno leto.
The first injection is given from three months of age and the second injection is given three weeks later. 
Prva injekcija se daje od starosti treh mesecev, druga pa tri tedne pozneje.
After the second injection, animals may show a slight, temporary increase in body temperature of 0.4 ºC, in the 24 hours after vaccination. 
Po drugem injiciranju cepiva se lahko pri živalih v prvih 24 urah pojavi rahlo in prehodno povišanje telesne temperature za 0,4 ºC.
Results from a series of laboratory safety trials performed with a vaccine of similar composition containing serotypes 1 and 8 and of studies performed with a vaccine of the same composition but of different serotype, used in sheep were presented in order to extrapolate safety conclusions. 
Predstavljeni so bili tudi rezultati niza laboratorijskih študij varnosti z uporabo cepiva s podobno sestavo, ki je vsebovalo serotipa 1 in 8, ter študij, opravljenih pri ovcah s cepivom z enako sestavo, vendar z drugačnim serotipom, da bi pridobili zaključke o varnosti.
The European Commission granted a marketing authorisation valid throughout the EU for ZULVAC 8 Bovis on 15 January 2010. 
Evropska komisija je dovoljenje za promet s cepivom ZULVAC 8 Bovis, veljavno po vsej Evropski uniji, odobrila dne 15. januarja 2010.
In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 8 Bovis to convert to a normal status. 
Leta 2013 je CVMP menil, da predloženi podatki zadostujejo, da dovoljenje za promet s cepivom ZULVAC 8 Bovis dobi običajen status.
The vaccine is given to animals as an injection in the muscle. 
Cepivo se živalim injicira v mišico.
When it is given to cattle, the immune system recognises the viruses as ‘foreign' and makes antibodies against them. 
Ko govedo prejme cepivo, imunski sistem viruse prepozna kot „tujke“ in proti njim razvije protitelesa.
ZULVAC 8 Bovis was initially authorised under ‘exceptional circumstances'. 
Cepivo ZULVAC 8 Bovis je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
In the future, if the animals are exposed to the bluetongue virus the immune system will be able to produce antibodies more quickly. 
Ob ponovni izpostavitvi virusu bolezni modrikastega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
The vaccine is used to prevent viraemia (the presence of the virus in the blood) in cattle from three months of age. 
Cepivo se uporablja za preprečevanje viremije (prisotnosti virusa v krvi) pri govedu, starejšem od treh mesecev.
The studies showed that the vaccine is safe for cattle and that it prevents viraemia in animals from three months of age that are infected with bluetongue virus serotype 8. 
Študije so pokazale, da je cepivo varno za uporabo pri govedu in preprečuje viremijo pri živalih, starejših od treh mesecev, ki so okužene z virusom bolezni modrikastega jezika, serotip 8.
The efficacy of the vaccine in cattle was studied in a laboratory trial using the vaccine in calves from two and a half months of age. 
Učinkovitost cepiva pri govedu so raziskovali v laboratorijski študiji, pri katerih so cepili teleta, starejša od dveh mesecev in pol.
Another laboratory study looked at the duration of the immunity following vaccination with ZULVAC 8 Bovis. 
V drugi laboratorijski študiji so raziskovali trajanje odpornosti po cepljenju s cepivom ZULVAC 8 Bovis.
ZULVAC 8 Bovis is a vaccine that is available as a suspension for injection. 
Zdravilo ZULVAC 8 Bovis je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
Other information about ZULVAC 8 Bovis: 
Druge informacije o zdravilu ZULVAC 8 Bovis:
ZULVAC 8 Bovis contains bluetongue virus of one type (serotype 8). 
Cepivo ZULVAC 8 Bovis vsebuje virus bolezni modrikastega jezika enega tipa (serotipa 8).
ZULVAC 8 Bovis is a vaccine. 
Zdravilo ZULVAC 8 Bovis je cepivo.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ZULVAC 8 Bovis exceed the risks in the prevention of viraemia caused by the bluetongue virus serotype 8 in cattle from three months of age. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so pri govedu, starejšem od treh mesecev, koristi cepiva ZULVAC 8 Bovis pri preprečevanju viremije, ki jo povzroča serotip 8 virusa bolezni modrikastega jezika, večje od z njim povezanih tveganj.
The withdrawal period for ZULVAC 8 Bovis for meat and milk is zero days. 
Karenca za cepivo ZULVAC 8 Bovis za meso in mleko je nič dni.
What benefit has ZULVAC 8 Bovis shown during the studies? 
Kakšne koristi je zdravilo ZULVAC 8 Bovis izkazalo med študijami?
It contains inactivated (killed) bluetongue serotype 8 virus. 
Vsebuje inaktiviran (uničen) virus modrikastega jezika, serotip 8.
ZULVAC 8 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. 
Cepivo ZULVAC 8 Bovis se uporablja pri govedu za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo povzroča virus bolezni modrikastega jezika, prenašajo pa jo trzače.
ZULVAC 8 Bovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease. 
Cepivo ZULVAC 8 Bovis vsebuje inaktivirane viruse bolezni modrikastega jezika, ki ne povzročajo bolezni.
What is the risk associated with ZULVAC 8 Bovis? 
Kakšna tveganja so povezana z zdravilom ZULVAC 8 Bovis?
The safety of the vaccine was studied in laboratory safety studies carried out with ZULVAC 8 Bovis in cattle. 
Varnost cepiva ZULVAC 8 Bovis je bila raziskana v laboratorijskih študijah varnosti z njegovo uporabo na govedu.
Why has ZULVAC 8 Bovis been approved? 
Zakaj je bilo zdravilo ZULVAC 8 Bovis odobreno?
How has ZULVAC 8 Bovis been studied? 
Kako je bilo zdravilo ZULVAC 8 Bovis raziskano?
What is ZULVAC 8 Bovis? 
Kaj je zdravilo ZULVAC 8 Bovis?
Inactivated vaccine against Bluetongue virus, serotype 8 
ZULVAC 8 Bovis inaktivirano cepivo proti virusu bolezni modrikastega jezika, serotip 8
How does ZULVAC 8 Bovis work? 
Kako zdravilo ZULVAC 8 Bovis deluje?
What is ZULVAC 8 Bovis used for? 
Za kaj se zdravilo ZULVAC 8 Bovis uporablja?
This means that it was not possible to obtain complete information about ZULVAC 8 Bovis at the time of the initial authorisation. 
To pomeni, da ob prvotni izdaji dovoljenja za promet ni bilo mogoče pridobiti vseh podatkov o tem cepivu.
Date of first authorisation: 16 August 2012 Date of latest renewal: 
Datum prve odobritve: 16. avgust 2012 Datum zadnjega podaljšanja:
You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal 
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih
This corresponds to a 28% reduction in the risk of all cause mortality (p=0.01). 
To ustreza 28-odstotnemu zmanjšanju tveganja za umrljivost iz katerega koli vzroka (p=0,01).
- you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer. 
- prejemate zdravila, ki jih imenujemo kortikosteroidi (kot sta prednizolon ali deksametazon), - imate raka.
• Key signs and symptoms of serious adverse events • When to seek attention from the health care provider 
• ključne znake in simptome resnih neželenih dogodkov, • navodila o tem, kdaj je treba poiskati zdravniško pomoč.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVZI Z VARNO IN UČINKOVITO UPORABO
Class effects: 
Učinki po skupinah:
Contents of the pack and other information 
Vsebina pakiranja in dodatne infomacije
• Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity 
• kontraindikacije med nosečnostjo in dojenjem zaradi možne teratogenosti,
Therefore, interactions resulting from displacement of highly protein-bound drugs are unlikely. 
Zato interakcije, ki se kažejo kot izrivanje zdravil pretežno vezanih na beljakovine, niso verjetne.
Zoledronic acid Teva Pharma may also cause other side effects Very common: may affect more than 1 in 10 people Fever. 
Zdravilo Zoledronska kislina Teva Pharma lahko povzroča tudi druge neželene učinke Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov Vročina.
Zoledronic acid demonstrated a consistent effect over 3 years, resulting in a 41% reduction in the risk of hip fractures (95% CI, 17% to 58%). 
Zoledronska kislina je pokazala stalen učinek v obdobju 3 let, kar je omogočilo 41-odstotno znižanje tveganja za zlom kolkov (95 % IZ: 17 % do 58 %).
It is important for your doctor to know all the medicines you are taking, especially if you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or diuretics (“waterpills”) that may cause dehydration. 
Pomembno je, da vaš zdravnik ve, katera zdravila jemljete, zlasti če jemljete zdravila, za katera je znano, da lahko škodujejo ledvicam (na primer aminoglikozide) ali diuretike (zdravila za odvajanje vode), ki lahko povzročajo dehidracijo.
• in adult men at increased risk of fracture, including those with a recent low-trauma hip fracture. 
• pri odraslih moških s povečanim tveganjem za zlome, vključno s tistimi z nedavnim zlomom kolka po lažji poškodbi.
It must not be mixed or given intravenously with any other medicinal products. 
Ne smete ga mešati ali dajati intravensko skupaj z drugimi zdravili.
• Need to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diurectic therapy 
• potrebo po zagotovitvi primerne hidriranosti bolnika, zlasti v primeru starejših bolnikov in bolnikov, ki prejemajo diuretično terapijo,
The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established. 
Varnost in učinkovitost zoledronske kisline pri otrocih in mladostnikih starih do 18 let nista bili dokazani.
Treatment of osteoporosis 
Zdravljenje osteoporoze
Incidence of individual adverse reactions following the first infusion was: pyrexia (17.1%), myalgia (7.8%), influenza-like illness (6.7%), arthralgia (4.8%) and headache (5.1%). 
Po prvi infuziji so bile incidence posameznih neželenih učinkov naslednje: pireksija (17,1 %), mialgija (7,8 %), gripi podobna bolezen (6,7 %), artralgija (4,8 %) in glavobol (5,1 %).
• A single dose of Zoledronic acid Teva Pharma should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2). 
• Posamezen odmerek zdravila Zoledronska kislina Teva Pharma ne sme presegati 5 mg, infuzija pa mora trajati najmanj 15 minut (glejte poglavje 4.2).
- you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone 
- nimate urejene redne oskrbe zob oziroma že dolgo niste bili na zobozdravstvenem pregledu, - ste kadilec (saj to lahko povečuje tveganje za težave z zobmi), - ste že kdaj prej prejemali katerega od difosfonatov (ki jih uporabljamo za zdravljenje ali
- Do not use this medicine if you notice any discolouration or particles in the solution. 
- Ne uporabljajte tega zdravila, če opazite, da je raztopina drugačne barve ali so v njej majhni delci.
Before receiving Zoledronic acid Teva Pharma treatment, tell your doctor, pharmacist or nurse if - you have any problems with your mouth or teeth such as poor dental health, gum disease, or a 
Preden prejmete zdravilo Zoledronska kislina Teva Pharma, povejte zdravniku, farmacevtu ali medicinski sestri, če: - imate težave v ustih oziroma z zobmi, kot so slabo zdravstveno stanje zob, bolezni dlesni ali
For information on the infusion of Zoledronic acid Teva Pharma, see section 6.6. 
Za informacije o infundiranju zdravila Zoledronska kislina Teva Pharma glejte poglavje 6.6.
Zoledronic acid significantly decreased the incidence of one or more new vertebral fractures over three years and as early as the one year timepoint (see Table 2). 
Zoledronska kislina je statistično značilno znižalo incidenco enega ali več novih zlomov vretenc tako v obdobju treh let kot tudi že po enem letu opazovanja (glejte preglednico 2).
Ask your doctor, pharmacist or nurse for advice before using this medicine. 
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden uporabite to zdravilo.
• Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non 
• potrebnost zadostnega nadomeščanja kalcija in vitamina D, ustrezne telesne dejavnosti in zdrave
The incidence rates of key clinical fracture variables are presented in Table 4. 
Stopnje incidenc ključnih kliničnih zlomov so prikazane v preglednici 4.