FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom(RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: • Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Croatian: • Preosjetljivost na djelatnu tvar, druge bisfosfonate ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Additional information on handling of Zoledronic acid Mylan, including guidance on preparation of reduced doses, is provided in section 4.2.
Croatian: Dodatne informacije o rukovanju Zoledronatnom kiselinom Mylan, uključujući i smjernice za pripremu smanjenih doza, dane su u dijelu 4.2.
English: How to store Zoledronic acid Mylan Your doctor, pharmacist or nurse knows how to store Zoledronic acid Mylan properly.
Croatian: Kako čuvati Zoledronatnu kiselinu Mylan Vaš liječnik, ljekarnik ili medicinska sestra znaju kako ispravno čuvati Zoledronatnu kiselinu Mylan.
English: Zoledronic acid Mylan contains the same active substance as found in medicinal products indicated for treatment of osteoporosis and Paget´s disease of the bone.
Croatian: Zoledronatna kiselina Mylan sadrži istu djelatnu tvar kao i lijekovi indicirani za liječenje osteoporoze i Pagetove bolesti kostiju.
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of zoledronic acid.
Croatian: Ako već imate hipokalcemiju, ona se mora korigirati prije uvođenja prve doze zoledronatne kiseline.
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: Kod procjene individualnog rizika za osteonekrozu čeljusti (ONČ) moraju se uzeti u obzir slijedeći čimbenici rizika: - Jačina bisfosfonata (veći rizik za vrlo jake spojeve), put primjene (veći rizik kod parenteralne primjene) i kumulativna doza bisfosfonata.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika i ne bi trebali biti dulji od 24 sata na temperaturi od 2°C - 8°C, osim ako se razrjeđivanje provelo u kontroliranim i validiranim aseptičkim uvjetima.
English: Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Croatian: - Uočeno je da se osteonekroza također vrlo rijetko pojavila i na drugim kostima osim čeljusti, naročito na kuku ili bedrima.
English: Vomiting, nausea
Croatian: povraćanje, mučnina
English: Statistically significant differences are marked (*p< 0.05) for between treatment comparisons (4 mg zoledronic acid vs.
Croatian: Označene su statistički značajne razlike (*p < 0,05) između dva liječenja (4 mg zoledronatne kiseline nasuprot placebu)
English: Aseptic techniques must be followed during the preparation of the infusion.
Croatian: Tijekom pripreme infuzije moraju se provoditi aseptičke tehnike.
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 Mylan 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 Mylan upravlja vozilima i radi sa strojevima.
English: - Cancer, co morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Croatian: - Rak, komorbiditetna stanja (npr. anemija, koagulopatije, infekcija), pušenje.
English: Median time to onset of the first SRE was not reached in the zoledronic acid-treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
Croatian: Medijan vremena do nastupa prvog koštanog događaja nije dosegnut u skupini liječenoj zoledronatnom kiselinom do kraja ispitivanja i bilo je značajno dulje u usporedbi s placebom (p = 0,007).
English: The active substance in Zoledronic acid Mylan is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Croatian: Djelatna tvar u Zoledronatnoj kiselini Mylan je zoledronatna kiselina, koja pripada skupini tvari koje se zovu bisfosfonati.
English: Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Croatian: Hipokalcemija je važan poznati rizik pri korištenju zoledronatne kiseline kod odobrenih indikacija.
English: Blood creatinine and blood urea increased, hypocalcaemia
Croatian: Povišeni kreatinin i urea u krvi, hipokalcemija
English: Zoledronic acid 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 ne preporučuje se u bolesnika koji prije početka liječenja imaju teško oštećenje funkcije bubrega, koje se u ove populacije definira kao CLcr < 30 ml/min.
English: 1 Adverse 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)
Croatian: 1 Štetni događaji koji nastaju s učestalošću < 5% bili su medicinski procijenjeni i pokazalo se da su u skladu s dobro utvrđenim sigurnosnim profilom zoledronatne kiseline (vidjeti dio 4.8).
English: Instructions for preparing reduced doses of Zoledronic acid Mylan: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose
Croatian: Upute za pripremu sniženih doza Zoledronatne kiseline Mylan: Izvucite sljedeći odgovarajući volumen tekućeg koncentrata: - 4,4 ml za dozu od 3,5 mg
English: It is used: - To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Croatian: Koristi se za: - sprječavanje koštanih komplikacija, npr. prijeloma, u odraslih bolesnika s koštanim metastazama (širenje raka iz primarnog mjesta u kosti).
English: (e.g. tooth extractions) and poorly fitting dentures.
Croatian: (npr. vađenje zuba) i slabo prianjajuće zubne proteze
English: How often you will be given Zoledronic acid Mylan - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid Mylan every three to four weeks.
Croatian: Koliko se često daje Zoledronatna kiselina Mylan - Ako se liječite radi sprječavanja koštanih komplikacija izazvanih metastazama, dobivat ćete jednu infuziju Zoledronatne kiseline Mylan svaka tri do četiri tjedna.
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 Mylan.
Croatian: - Ako se liječite radi snižavanja količine kalcija u krvi, obično ćete dobiti samo jednu infuziju
English: - From a microbiological point of view, the diluted solution for infusion should be used immediately.
Croatian: S mikrobiološkog stajališta, razrijeđena otopina za infuziju treba se odmah primijeniti.
English: What Zoledronic acid Mylan looks like and contents of the pack Zoledronic acid Mylan is a clear and colourless concentrate for solution for infusion.
Croatian: Kako Zoledronatna kiselina Mylan izgleda i sadržaj pakiranja Zoledronatna kiselina Mylan je bistar i bezbojni koncentrat za otopinu za infuziju.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion Multipack: 4 (4 packs of 1) vials of 5 ml
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju Višestruko pakiranje: 4 (4 pakiranja od 1) bočice od 5 ml
English: What Zoledronic acid Mylan is and what it is used for What you need to know before you are given Zoledronic acid Mylan How Zoledronic acid Mylan is used Possible side effects
Croatian: Što je Zoledronatna kiselina Mylan i za što se koristi Što morate znati prije nego primite Zoledronatnu kiselinu Mylan Kako primjenjivati Zoledronatnu kiselinu Mylan Moguće nuspojave
English: Zoledronic acid Mylan 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.
Croatian: Zoledronatnu kiselinu Mylan 4 mg/5 ml koncentrat za otopinu za infuziju, dodatno razrijeđenu u 100 ml (vidjeti dio 6.6), treba dati kao jednokratnu intravensku infuziju u trajanju od najmanje 15 minuta.
English: Patients being treated with Zoledronic acid Mylan should not be treated with such medicinal products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Croatian: Bolesnici koji se liječe Zoledronatnom kiselinom Mylan ne smiju se istovremeno liječiti takvim lijekovima ili bilo kojim drugim bisfosfonatom, budući da nisu poznati kombinirani učinci tih lijekova.
English: How to store Zoledronic acid Mylan Contents of the pack and other information
Croatian: Kako čuvati Zoledronatnu kiselinu Mylan Sadržaj pakiranja i druge informacije
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 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 (vidjeti također dio 4.4):
English: - Since no data are available on the compatibility of Zoledronic acid Mylan with other intravenously administered substances, Zoledronic acid Mylan must not be mixed with other medicinal products/substances and should always be given through a separate infusion line.
Croatian: - Budući da nema dostupnih podataka o kompatibilnosti Zoledronatne kiseline Mylan s drugim tvarima za intravensku primjenu, Zoledronatna kiselina Mylan ne smije se miješati s drugim lijekovima/tvarima i uvijek se mora primjenjivati putem zasebne infuzijske linije
English: The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Croatian: Preporučena doza kod hiperkalcemije (serumski kalcij korigiran za albumin ≥ 12,0 mg/dl ili 3,0 mmol/l) je jednokratna doza od 4 mg Zoledronatne kiseline.
English: Zoledronic acid recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
Croatian: Preporučena doza zoledronatne kiseline* 4,0 mg zoledronatne kiseline 3,5 mg* zoledronatne kiseline 3,3 mg* zoledronatne kiseline 3,0 mg* zoledronatne kiseline *Doze su izračunate uz pretpostavku da je ciljni AUC 0,66 (mg•hr/l) (CLcr = 75 ml/min).
English: It is especially important that you tell your doctor if you are also taking: - Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Croatian: Osobito je važno da obavijestite liječnika ako također uzimate: - Aminoglikozide (lijekovi za liječenje teških infekcija), kalcitonin (vrsta lijeka za liječenje postmenopauzalne osteoporoze i hiperkalcemije), diuretici Henleove petlje (vrsta lijekova za liječenje visokog krvnog tlaka ili edema) ili drugi lijekovi koji snizuju razinu kalcija, budući da kombinacija ovih lijekova s bisfosfonatima može dovesti do preniskih razina kalcija u krvi - Talidomid (lijek za liječenje određenih vrsta raka krvi koji zahvaća kost) ili neke druge lijekove koji mogu oštetiti bubrege
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA 1 BOČICU
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 Zometom.
English: Instructions for preparing reduced doses of Zoledronic acid Mylan
Croatian: Upute za pripremu sniženih doza Zoledronatne kiseline Mylan
English: - Blurred vision, tearing of the eye, eye sensitivity to light.
Croatian: - Pojačano znojenje - Pospanost - Zamagljen vid, suzenje oka, osjetljivost očiju na svjetlost
English: Caution is advised when zoledronic acid is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Croatian: Savjetuje se oprez kod primjene zoledronatne kiseline s lijekovima za koje je poznato da uzrokuju hipokalcemiju budući da mogu imati sinergistički učinak s posljedičnom teškom hipokalcemijom (vidjeti dio 4.5).
English: Packs containing 1, 4 or 10 vials or multipacks containing 4 (4 cartons of 1) vials.
Croatian: Pakiranja koja sadrže 1, 4 ili 10 bočica ili višestruka pakiranja koja sadrže 4 (4 kutije po 1) bočice.
English: BOX OF 4 VIALS
Croatian: KUTIJA ZA 4 BOČICE
English: BOX OF 10 VIALS
Croatian: KUTIJA ZA 10 BOČICA
English: 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.
Croatian: Dugotrajna ispitivanja ponovljene parenteralne doze u životinja pokazala su uzak raspon sigurnosti s obzirom na učinke na bubrege, ali najviša kumulativna doza koja ne uzrokuje štetne učinke (NOAEL) u ispitivanjima jednostruke doze (1,6 mg/kg) i višestrukih doza u trajanju do jednog mjeseca (0,060,6 mg/kg na dan) nije imala učinke na bubrege pri dozama jednakima ili višima od najviše terapijske doze namijenjene ljudima.
English: The following conventional classification is used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave navedene prema učestalosti prikazane su u tablici 6. Korištena je sljedeća klasifikacija: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Uncommon (may affect up to 1 in 100 people): - Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Croatian: Manje često (može se javiti u do 1 na 100 osoba): - Bol u ustima, zubima i/ili čeljusti, oteklina ili ranice u ustima ili čeljusti koje ne cijele, iscjedak, utrnulost ili osjećaj težine u čeljusti, klimanje zuba.
English: Caution is advised when zoledronic acid is administered with anti-angiogenic medicinal products as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Croatian: Savjetuje se oprez kod primjene zoledronatne kiseline s antiangiogenim lijekovima jer je primjećena veća incidencija osteonekroze čeljusti u bolesnika koji su istovremeno liječeni tim lijekovima.
English: What Zoledronic acid Mylan is and what it is used for
Croatian: Što je Zoledronatna kiselina Mylan i za što se koristi
English: - History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures
Croatian: - Anamneza bolesti zubi, loša higijena usta, periodontalna bolest, invazivni stomatološki zahvati
English: The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid-treated group versus 49.6% in the placebo group (p=0.003).
Croatian: Udio bolesnika s barem jednim koštanim događajem (isključujući hiperkalcemiju) iznosio je 29,8% u skupini liječenoj zoledronatnom kiselinom i 49,6% u skupini koja je primala placebo (p = 0,003).
English: Pyrexia, fatigue
Croatian: pireksija, umor
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 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 is not recommended in patients with severe renal impairment.
Croatian: S obzirom na mogući utjecaj bisfosfonata, uključujući i zoledronatnu kiselinu, 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 μmol/l ili ≥ 4,5 mg/dl u bolesnika s hiperkalcemijom izazvanom tumorom, odnosno ≥ 265 μmol/l ili ≥ 3,0 mg/dl u bolesnika s rakom i metastazama u kostima) na početku liječenja i ograničene farmakokinetičke podatke u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min) na početku liječenja, ne preporučuje se primjena zoledronatne kiseline u bolesnika s teškim oštećenjem funkcije bubrega.
English: There was faster normalisation of corrected serum calcium at day 4 for 8 mg zoledronic acid and at day 7 for 4 mg and 8 mg zoledronic acid.
Croatian: Pronašla se brža normalizacija korigiranog kalcija u serumu 4. dana kod doze zoledronatne kiseline od 8 mg i 7. dana kod doze zoledronatne kiseline od 4 mg i 8 mg.
English: Common (may affect up to 1 in 10 people): - Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Croatian: Često (može se javiti u do 1 na 10 osoba): - Teško oštećenje funkcije bubrega (obično će ga utvrditi liječnik pomoću određenih specifičnih krvnih pretraga) - Niska razina kalcija u krvi.
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%), karcinom prostate (3,1%), karcinom dojke (4,3%), karcinom pluća i drugi solidni tumori (3,2%).
English: What you need to know before you are given Zoledronic acid Mylan
Croatian: Što morate znati prije nego primite Zoledronatnu kiselinu Mylan
English: - The other ingredients are: sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.
Croatian: - Drugi sastojci su: natrijev citrat, natrijev hidroksid, kloridna kiselina i voda za injekcije.
English: Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Croatian: Manje često (može se javiti u do 1 na 100 osoba): - Reakcije preosjetljivosti
English: - Flu-like symptoms including arthritis and joint swelling.
Croatian: - Simptomi nalik gripi uključujući artritis i oticanje zglobova.
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 vrijednosti kalcija: napadaji, utrnulost, tetanija (posljedica hipokalcemije).
English: Patients treated with Zoledronic acid Mylan should be given the package leaflet and the patient reminder card.
Croatian: Bolesnicima koji se liječe Zoledronatnom kiselinom Mylan potrebno je dati Uputu o lijeku i karticu-podsjetnik za bolesnika.
English: LIST OF EXCIPIENTS It also contains sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.
Croatian: POPIS POMOĆNIH TVARI Također sadrži natrijev citrat, natrijev hidroksid, kloridnu kiselinu i vodu za injekcije.
English: - Zoledronic acid Mylan must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Croatian: - Zoledronatnu kiselinu Mylan smiju davati samo zdravstveni radnici iskusni u davanju bisfosfonata intravenskim putem, tj. u venu.
English: Marketing Authorisation Holder Mylan S.A.S.
Croatian: Nositelj odobrenja za stavljanje u promet lijeka Mylan S.A.S.
English: Fertility, pregnancy and lactation
Croatian: 4.6 Plodnost, trudnoća i dojenje
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Croatian: Astenija, periferni edemi, reakcije na mjestu primjene injekcije (uključujući bol, nadraženost, oteklinu i otvrdnuće), bol u prsištu, povećanje tjelesne težine, anafilaktična reakcija/šok, urtikarija
English: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Croatian: Proljev, zatvor, bol u abdomenu, dispepsija, stomatitis, suha usta
English: Only clear solution free from particles and discolouration should be used.
Croatian: Smije se upotrijebiti samo bistra otopina bez čestica i promjene boje.
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 razmotrenih slučajeva za vrijeme kliničkog ispitivanja i nakon stavljanja lijeka na tržište, sakupljeno je dovoljno dokaza koji podupiru povezanost terapije zoledronatnom kiselinom sa zabilježenim slučajevima hipokalcemije i posljedičnog razvoja srčane aritmije.
English: How Zoledronic acid Mylan is given - Zoledronic acid Mylan is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Croatian: Kako se daje Zoledronatna kiselina Mylan - Zoledronatna kiselina Mylan daje se u venu kao infuzija (drip) u trajanju od najmanje 15 minuta i mora se primijeniti kao jednokratna intravenska otopina putem zasebnog infuzijskog sustava.