FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Zoledronic acid Actavis is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Croatian: Djelatna tvar u Zoledronatnoj kiselini Actavis je zoledronatna kiselina, koja pripada skupini tvari koje se zovu bisfosfonati.
English: Contains mannitol, sodium citrate and water for injections.
Croatian: Sadrži manitol, natrijev citrat i vodu za injekcije.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer)
Croatian: Tablica 3: Rezultati djelotvornosti (solidni tumori osim raka dojke i prostate)
English: Caution is indicated when Zoledronic acid Actavis is used with other potentially nephrotoxic medicinal products.
Croatian: Potreban je oprez kad se Zoledronatna kiselina Actavis koristi s drugim potencijalno nefrotoksičnim lijekovima.
English: Warnings and precautions Talk to your doctor before you are given Zoledronic acid Actavis:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego primite Zoledronatnu kiselinu Actavis:
English: - The other ingredients are: mannitol, sodium citrate and water for injections.
Croatian: - Drugi sastojci su: manitol, natrijev citrat i voda za injekcije.
English: Contents of the pack and other information What Zoledronic acid Actavis contains
Croatian: Sadržaj pakiranja i druge informacije Što Zoledronatna kiselina Actavis sadrži
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic acid Actavis.
Croatian: Vaš liječnik može preporučiti pregled kod zubara prije nego počnete liječenje Zoledronatnom kiselinom Actavis.
English: 5 ml concentrate in a plastic vial made of clear, colourless oleofinic polymer closed with fluoropolymer-coated bromobutyl rubber stopper and aluminium cap with plastic flip-off component.
Croatian: Plastična bočica s 5 ml koncentrata izrađena od prozirnog, bezbojnog oleofinskog polimera zatvorena brombutilnim gumenim čepom obloženim fluoropolimerom i aluminijskim zatvaračem s plastičnim „flip-off“ poklopcem.
English: From a microbiological point of view, the solution for infusion should be used immediately after dilution.
Croatian: S mikrobiološkog stajališta, otopinu za infuziju treba primijeniti odmah nakon razrjeđivanja.
English: Zoledronic acid Actavis should not be used during pregnancy.
Croatian: Zoledronatna kiselina Actavis se ne smije primjenjivati tijekom trudnoće.
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy)
Croatian: Tablica 2: Rezultati djelotvornosti (bolesnici s rakom prostate koji primaju hormonsku terapiju)
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid Actavis.
Croatian: Ako već imate hipokalcemiju, ona se mora korigirati prije uvođenja prve doze Zoledronatne kiseline Actavis.
English: Following initiation of therapy, serum creatinine should be measured prior to each dose of Zoledronic acid Actavis and treatment should be withheld if renal function has deteriorated.
Croatian: Nakon početka liječenja kreatinin u serumu treba mjeriti prije primjene svake doze Zoledronatne kiseline Actavis, a liječenje treba obustaviti ako se funkcija bubrega pogorša.
English: Very rare (may affect up to 1 in 10,000 people): - As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Croatian: Vrlo rijetko (može se javiti u do 1 na 10 000 osoba): - Kao posljedica niskih razina kalcija: napadaji, utrnulost i tetanija (uslijed hipokalcemije).
English: If you are given more Zoledronic acid Actavis than you should be
Croatian: Ako ste primili više Zoledronatne kiseline Actavis nego što ste trebali
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to zoledronic acid administration.
Croatian: Tijekom liječenja, invazivne stomatološke zahvate treba izvoditi tek nakon pažljivog razmatranja i izbjegavati ih neposredno blizu primjene zoledronatne kiseline
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal 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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži zoledronatnu kiselinu u svim podskupinama pedijatrijske populacije u liječenju hiperkalcemije izazvane tumorom i sprječavanju događaja povezanih s koštanim sustavom u bolesnika s uznapredovalom zloćudnom bolešću koja zahvaća kosti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic acid Actavis.
Croatian: Ako se liječite radi snižavanja količine kalcija u krvi, obično ćete dobiti samo jednu infuziju
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Croatian: - Antiangiogene lijekove (primjenjuju se za liječenje raka), budući da je kombinacija ovih lijekova sa zoledronatnom kiselinom povezana s povećanim rizikom osteonekroze čeljusti.
English: Very rare (may affect up to 1 in 10,000 people): - Fainting due to low blood pressure.
Croatian: Vrlo rijetko (može se javiti u do 1 na 10 000 osoba): - Nesvjestica zbog niskog krvnog tlaka.
English: Zoledronic acid Actavis 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.
Croatian: Zoledronatna kiselina Actavis se ne preporučuje u bolesnika koji prije početka liječenja imaju teško oštećenje funkcije bubrega, koje se u ove populacije definira kao CLcr < 30 ml/min.
English: - Other medicines that contain zoledronic acid which are used to treat osteoporosis and other noncancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic acid Actavis are unknown.
Croatian: - Druge lijekove koji sadrže zoledronatnu kiselinu i koriste se za liječenje osteoporoze i drugih bolesti kostiju koje nisu uzrokovane rakom ili bilo koji drugi bisfosfonat, budući da kombinirani učinci ovih lijekova kad se uzimaju zajedno sa Zoledronatnom kiselinom Actavis nisu poznati.
English: 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 Actavis along with driving and operating of machinery.
Croatian: Nuspojave poput omaglice i somnolencije mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima te je stoga potreban oprez kad se tijekom primanja Zoledronatne kiseline Actavis upravlja vozilima i radi sa strojevima.
English: - Sudden coldness with fainting, limpness or collapse.
Croatian: - Iznenadan osjećaj hladnoće s nesvjesticom, posrtanjem ili kolapsom.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½ α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Croatian: Intravenski primijenjena zoledronatna kiselina eliminira se procesom u tri faze: brzim bifazičnim nestankom iz sistemskog krvotoka, uz poluvijek t1/2α od 0,24 sata i t1/2β od 1,87 sati, za kojim slijedi dugotrajna faza eliminacije uz terminalni poluvijek eliminacije t1/2γ od 146 sati.
English: Clear and colourless concentrate for solution for infusion.
Croatian: Bistar i bezbojan koncentrat za otopinu za infuziju.
English: Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Croatian: 4 mg zoledronatne kiseline (N=86) 45,3% (p=0,104) 82,6% (p=0,005)* 88,4% (p=0,002)* 8 mg zoledronatne kiseline (N=90) 55,6% (p=0,021)* 83,3% (p=0,010)* 86,7% (p=0,015)* 90 mg pamidronata (N=99) *p-vrijednosti uspoređene s pamidronatom.
English: If refrigerated, the solution must be allowed to reach room temperature before administration.
Croatian: Ako se čuva u hladnjaku, otopina se prije primjene mora ostaviti da dosegne sobnu temperaturu.
English: 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.
Croatian: Dodatno, bilo je sporadičnih prijava osteonekroze drugih anatomskih mjesta, uključujući kuk i bedrenu kost, koje su bile prijavljene pretežno u odraslih bolesnika oboljelih od raka liječenih zoledronatnom kiselinom.
English: In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Croatian: Bolesnici uključeni u klinički program u dobi od 1 do < 3 godine primali su 0,025 mg/kg zoledronatne kiseline (do najveće jednokratne doze od 0,35 mg) svaka 3 mjeseca, a bolesnici u dobi od 3 do 17 godina primali su 0,05 mg/kg zoledronatne kiseline (do najviše jednokratne doze od 0,83 mg)
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107. c stavkom 7. Direktive
English: The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Croatian: Sljedeće nuspojave navedene u Tablici 1, prikupljene su iz kliničkih ispitivanja i prijava nakon stavljanja lijeka u promet, uglavnom kod kroničnog liječenja sa 4 mg zoledronatne kiseline:
English: 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 Actavis dose is recommended (see also section 4.4):
Croatian: U bolesnika s metastazama u kostima koji prije početka liječenja imaju blago do umjereno oštećenje funkcije bubrega, koje se u ove populacije definira kao CLcr od 30 do 60 ml/min, preporučuje se sljedeća doza Zoledronatne kiseline Actavis (vidjeti također dio 4.4):
English: The onset time is ≤ 3 days post-zoledronic acid infusion (used as indicated in sections 4.1 and 4.2), and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Croatian: Vrijeme nastupa je ≤ 3 dana nakon infuzije zoledronatne kiseline (ako se koristila sukladno navedenom u dijelovima 4.1 i 4.2), a reakcija se još zove „sindrom nalik gripi” ili simptomi „nakon doziranja”.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR VIALS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJE ZA BOČICE
English: Zoledronic acid, used as indicated in sections 4.1 and 4.2, has been associated with reports of renal dysfunction.
Croatian: Kad se zoledronatna kiselina koristi sukladno navedenom u dijelovima 4.1 i 4.2, povezuje se s prijavama poremećaja funkcije bubrega.
English: - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid Actavis every three to four weeks.
Croatian: Ako se liječite radi sprječavanja koštanih komplikacija izazvanih metastazama, dobivat ćete jednu infuziju Zoledronatne kiseline Actavis svaka tri do četiri tjedna.
English: 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 micromol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 micromol/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 Actavis is not recommended in patients with severe renal impairment.
Croatian: S obzirom na mogući utjecaj zoledronatne kiseline na funkciju bubrega, nedostatak kliničkih podataka o sigurnosti primjene u bolesnika s teškim oštećenjem funkcije bubrega (u kliničkim ispitivanjima definiranim kao kreatinin u serumu ≥ 400 mikromola/l ili ≥ 4,5 mg/dl u bolesnika s hiperkalcemijom izazvanom tumorom, odnosno ≥ 265 mikromola/l ili ≥ 3,0 mg/dl u bolesnika s rakom i metastazama u kostima) na početku liječenja i samo ograničene farmakokinetičke podatke u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min) na početku liječenja, ne preporučuje se primjena Zoledronatne kiseline Actavis u bolesnika s teškim oštećenjem funkcije bubrega.
English: • To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Croatian: • Sprječavanje koštanih komplikacija, npr. prijeloma, u odraslih bolesnika s koštanim metastazama (širenje raka iz primarnog mjesta u kosti).
English: Increases in serum creatinine also occur in some patients with chronic administration of zoledronic acid at recommended doses for prevention of skeletal related events, although less frequently.
Croatian: U nekih bolesnika također dolazi do povišenja kreatinina u serumu i kod kronične primjene zoledronatne kiseline u dozama koje se preporučuju za sprječavanje koštanih događaja, iako manje često.
English: - For storage conditions of Zoledronic acid Actavis after dilution, see “Shelf life after dilution”
Croatian: - Za uvjete čuvanja Zoledronatne kiseline Actavis nakon razrjeđivanja, vidjeti pod „Rok valjanosti nakon razrjeđivanja“.
English: You will be given adequate calcium and vitamin D supplements.
Croatian: Dobit ćete odgovarajuće nadomjestke kacija i vitamina D.
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Croatian: Osteonekroza vanjskog slušnog kanala prijavljena je s bisfosfonatima, uglavnom u vezi s dugotrajnom terapijom.
English: - Since no data are available on the compatibility of Zoledronic acid Actavis with other intravenously administered substances, Zoledronic acid Actavis must not be mixed with other medications/substances and should always be given through a separate infusion line.
Croatian: - Budući da nema dostupnih podataka o kompatibilnosti Zoledronatne kiseline Actavis s drugim tvarima za intravensku primjenu, Zoledronatna kiselina Actavis ne smije se miješati s drugim lijekovima/tvarima i uvijek se mora primjenjivati kroz zasebnu infuzijsku liniju.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. može se smatrati da lijek „ne sadrži natrij“.
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.
Croatian: Snižene razine kalcija u krvi (hipokalcemija), koje su ponekad dovele do mišićnih grčeva, suhoće kože, osjećaja peckanja, zabilježene su u bolesnika liječenih zoledronatnom kiselinom.
English: • At the request of the European Medicines Agency,
Croatian: Ažurirani RMP treba dostaviti: • na zahtjev Europske agencije za lijekove;
English: Other products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Croatian: Dostupni su drugi lijekovi koji sadrže zoledronatnu kiselinu kao djelatnu tvar indicirani kod osteoporoze i za liječenje Pagetove bolesti kostiju.
English: What you need to know before you are given Zoledronic acid Actavis
Croatian: Što morate znati prije nego počnete primati Zoledronatnu kiselinu Actavis
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Croatian: Utvrđeni su sljedeći važni rizici primanja zoledronatne kiseline u odobrenim indikacijama: oštećenje funkcije bubrega, osteonekroza čeljusti, reakcija akutne faze, hipokalcemija, fibrilacija atrija,
English: Zoledronic acid Actavis treatment should be resumed at the same dose as that given prior to treatment interruption.
Croatian: Liječenje Zoledronatnom kiselinom Actavis treba nastaviti istom dozom koja se davala prije prekida liječenja.
English: How to store Zoledronic acid Actavis Contents of the pack and other information
Croatian: Kako čuvati Zoledronatnu kiselinu Actavis Sadržaj pakiranja i druge informacije
English: The following risk factors should be considered when evaluating an individual's risk of developing ONJ: - Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Croatian: Sljedeće čimbenike rizika treba uzeti u obzir kada se kod pojedinca ocjenjuje rizik od razvoja osteonekroze čeljusti ( ONČ): - Potentnost bisfosfonata (veći rizik kod visoko potentnih spojeva), put primjene (veći rizik kod parenteralne primjene) i kumulativnu dozu bisfosfonata. - -Rak, komorbiditetna stanja (npr. anemija, koagulopatije, infekcija), pušenje.
English: For storage conditions of Zoledronic acid Actavis after dilution, see section 6.3.
Croatian: Uvjete čuvanja Zoledronatne kiseline Actavis nakon razrjeđivanja vidjeti u dijelu 6.3.
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.
Croatian: Na temelju pregleda slučajeva iz kliničkih ispitivanja i nakon stavljanja lijeka u promet postoji dovoljno dokaza o povezanosti između liječenja zoledronatnom kiselinom, zabilježenih događaja hipokalcemije i razvoja srčane aritmije kao njene posljedice.
English: If a lower dose of Zoledronic acid Actavis is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Croatian: Actavis, prvo izvucite odgovarajući volumen kako je navedeno niže, i potom ga dodatno razrijedite sa 100 ml otopine za infuziju.
English: Blurred vision, scleritis and orbital inflammation Uveitis
Croatian: Zamagljen vid, skleritis i upala orbite Uveitis
English: In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Croatian: U analizi objedinjenih podataka o sigurnosti primjene zoledronatne kiseline iz registracijskih ispitivanja za sprječavanje koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti, sumnjalo se da je učestalost štetnih događaja oštećenja funkcije bubrega povezana sa zoledronatnom kiselinom (nuspojava) na sljedeći način: multipli mijelom (3,2%), rak prostate (3,1%), rak dojke (4,3%), rak pluća i drugi solidni tumori (3,2%).
English: Patients must be assessed prior to administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
Croatian: Bolesnici moraju biti pregledani prije primjene Zoledronatne kiseline Actavis kako bi se potvrdilo da su odgovarajuće hidrirani.
English: The following properties have been demonstrated in preclinical studies: - In vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Croatian: U nekliničkim ispitivanjima pokazala je sljedeća svojstva: - in vivo: inhibicija osteoklastične resorpcije kosti, koja mijenja mikrookoliš koštane srži i čini je manje pogodnom za rast tumorskih stanica, antiangiogeno djelovanje i analgetsko djelovanje.
English: Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Croatian: Rijetko (može se javiti u do 1 na 1000 osoba): - Usporen rad srca.
English: What Zoledronic acid Actavis is and what it is used for What you need to know before you are given Zoledronic acid Actavis How Zoledronic acid Actavis is used Possible side effects
Croatian: Što je Zoledronatna kiselina Actavis i za što se koristi Što morate znati prije nego počnete primati Zoledronatnu kiselinu Actavis Kako primjenjivati Zoledronatnu kiselinu Actavis
English: To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
Croatian: Da bi se procijenili učinci 4 mg zoledronatne kiseline u usporedbi sa 90 mg pamidronata, u unaprijed planiranoj analizi kombinirali su se rezultati dva glavna multicentrična ispitivanja u bolesnika s
English: - Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
Croatian: - Liječnik će Vam savjetovati da prije svake primjene Zoledronatne kiseline Actavis popijete dovoljnu količinu vode, kako bi se spriječila dehidracija.
English: NR 714
Croatian: ND ND 424
English: Zoledronic acid Actavis is contraindicated in breast-feeding women (see section 4.3).
Croatian: Zoledronatna kiselina Actavis je kontraindicirana tijekom dojenja (vidjeti dio 4.3).
English: EXP Shelf life after dilution: See leaflet.
Croatian: EXP Rok valjanosti nakon razrjeđivanja: vidjeti uputu o lijeku.
English: - High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
Croatian: - Visok krvni tlak, nedostatak zraka, omaglica, tjeskoba, poremećaji spavanja, promjena osjeta okusa, drhtavica, trnci ili utrnulost šaka ili stopala, proljev, zatvor, bol u trbuhu, suha usta.
English: What Zoledronic acid Actavis is and what it is used for
Croatian: Što je Zoledronatna kiselina Actavis i za što se koristi
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) .
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: You should not be given Zoledronic acid Actavis:
Croatian: Ne smijete primiti Zoledronatnu kiselinu Actavis:
English: Actavis Italy S.p.A Via Pasteur, 10 20014 Nerviano (MI) Italy
Croatian: Actavis Italy S.p.A Via Pasteur, 10
English: Patients must be maintained well hydrated prior to and following administration of Zoledronic acid Actavis.
Croatian: Bolesnici moraju biti dobro hidrirani prije i nakon primjene Zoledronatne kiseline Actavis.
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Croatian: Tablica 4: Rezultati djelotvornosti (u bolesnika s rakom dojke i multiplim mijelomom)
English: - Zoledronic acid Actavis must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Croatian: - Zoledronatnu kiselinu Actavis smiju davati samo zdravstveni radnici iskusni u davanju bisfosfonata intravenskim putem, tj. u venu.