FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several anti-tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Croatian: Osim što je jaki inhibitor resorpcije kosti, zoledronatna kiselina također ima nekoliko antitumorskih svojstava koja bi mogla pridonositi njezinoj cjelokupnoj djelotvornosti u liječenju metastatske koštane bolesti.
English: • If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Croatian: • Ako imate tegobe s bubrezima, liječnik će Vam dati nižu dozu ovisno o težini tegoba koje imate s bubrezima.
English: • Weight increase.
Croatian: • povećanje tjelesne težine.
English: Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Croatian: Tijekom prva 24 sata, 39 ± 16% primijenjene doze otkrije se u mokraći, dok se preostali dio u načelu veže za koštano tkivo.
English: While being treated with Zoledronic Acid Accord, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Croatian: Za vrijeme liječenja Zoledronatnom kiselinom Accord, morate održavati dobru oralnu higijenu (uključujući redovito pranje zuba) i obavljati rutinske preglede kod zubara.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1
Croatian: Tablica 6: Nuspojave primijećene u pedijatrijskih bolesnika s teškim oblikom osteogenesis imperfecta1
English: • if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Accord and inform your doctor about your dental treatment.
Croatian: • ako se liječite kod zubara ili trebate ići na zubarski kirurški zahvat, obavijestite svog zubara da se liječite Zoledronatnom kiselinom Accord i obavijestite svog liječnika o Vašem liječenju kod zubara.
English: Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including; convulsions, hypoaesthesia and tetany (see section 4.4).
Croatian: Nadalje, postoje dokazi o povezanosti između hipokalcemije i posljedičnih neuroloških događaja prijavljenih u ovim slučajevima, uključujući konvulzije, hipoesteziju i tetaniju (vidjeti dio 4.4).
English: Zoledronic Acid Accord is supplied as packs containing 1, 4 or 10 vials.
Croatian: Zoledronatna kiselina Accord isporučuje se u pakiranjima od 1, 4 ili 10 bočica.
English: Chemical and physical in-use stability has been demonstrated for 36 hours at 2 - 8 °C.
Croatian: Dokazana kemijska i fizikalna stabilnost iznosi 36 sati na temperaturi od 2 - 8°C.
English: After dilution: From a microbiological point of view, the product should be used immediately.
Croatian: Nakon razrjeđenja: s mikrobiološkog stajališta, lijek treba odmah primijeniti.
English: • Low blood pressure.
Croatian: • nizak krvni tlak.
English: EU/1/13/834/002
Croatian: EU/1/13/834/001 EU/1/13/834/002 EU/1/13/834/003
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate) Clear and colourless solution.
Croatian: OBLIK Koncentrat za otopinu za infuziju (sterilni koncentrat) Bistra i bezbojna otopina.
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.
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.
English: Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have higher risk of developing osteonecrosis of the jaw.
Croatian: Bolesnici kod kojih je u tijeku kemoterapija i/ili radioterapija, koji uzimaju steroide, koji idu na kirurški zahvat zuba, koji ne obavljaju rutinske preglede kod zubara, koji imaju bolest desni, koji su pušači, ili koji su se prije liječili bisfosfonatima (u svrhu liječenja ili prevencije poremećaja kostiju) mogu imati veći rizik razvoja osteonekroze čeljusti.
English: Caution is indicated when zoledronic acid is used with other potentially nephrotoxic medicinal products.
Croatian: Potreban je oprez kad se zoledronatna kiselina primjenjuje s drugim potencijalno nefrotoksičnim lijekovima.
English: • A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Croatian: • Poremećaj rada bubrega koji se zove Fanconijev sindrom (kojeg inače može odrediti Vaš liječnik pomoću određenih testova urina).
English: • The other ingredients are: mannitol, sodium citrate, water for injections.
Croatian: • Drugi sastojci su: manitol, natrijev citrat, voda za injekcije.
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 to 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: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Croatian: hipertenzija, hipotenzija, fibrilacija atrija, hipotenzija s posljedičnom sinkopom ili cirkulacijskim kolapsom
English: Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Croatian: Hipokalcemija predstavlja važan potvrđeni rizik vezan za zoledronatnu kiselinu u odobrenim indikacijama.
English: The study treatment period was 12 months preceded by a 4- to 9-week screening period during which vitamin D and elemental calcium supplements were taken for at least 2-weeks.
Croatian: Ispitivano liječenje trajalo je 12 mjeseci, a prethodilo mu je probirno razdoblje od 4 do 9 tjedana tijekom kojeg su bolesnici uzimali vitamin D i nadomjeske elementarnog kalcija tijekom najmanje 2 tjedna.
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: • Slow heart beat.
Croatian: • usporen rad srca.
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Accord.
Croatian: Vaš liječnik može preporučiti pregled kod zubara prije nego počnete liječenje Zoledronatnom kiselinom Accord.
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Accord.
Croatian: Ako već imate hipokalcemiju, ona se mora korigirati prije uvođenja prve doze Zoledronatne kiseline Accord.
English: For instructions on the dilution of zoledronic acid before administration, see section 6.6.
Croatian: Za upute o razrjeđivanju zoledronatne kiseline prije primjene vidjeti dio 6.6.
English: Zoledronic Acid Accord 4 mg 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 Accord 4 mg koncentrat za otopinu za infuziju, dodatno razrijeđen u 100 ml (vidjeti dio 6.6), treba dati kao jednokratnu intravensku infuziju u trajanju od najmanje 15 minuta.
English: In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralization or mechanical properties of bone.
Croatian: U dugotrajnim ispitivanjima na životinjama, zoledronatna kiselina inhibirala je resorpciju kosti bez štetnog djelovanja na stvaranje, mineralizaciju ili mehanička svojstva kosti.
English: • Painful redness and/or swelling of the eye.
Croatian: • bolno crvenilo i/ili oticanje oka.
English: The diluted Zoledronic Acid Accord infusion solution should be used immediately in order to avoid microbial contamination.
Croatian: • Razrijeđenu otopinu Zoledronatne kiseline Accord za infuziju treba primijeniti odmah kako bi se izbjegla mikrobiološka kontaminacija.
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 bio je značajno dulji u usporedbi s placebom (p=0,007).
English: • Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Croatian: • teško oštećenje funkcije bubrega (obično će ga utvrditi liječnik pomoću određenih specifičnih krvnih pretraga)
English: No pharmacokinetic data for zoledronic acid are available in patients with hypercalcaemia or in patients with hepatic insufficiency.
Croatian: Nema dostupnih farmakokinetičkih podataka za zoledronatnu kiselinu u bolesnika s hiperkalcemijom ili bolesnika sa insuficijencijom jetre.
English: • Thalidomide (a medicine used to treat a certain type of blood cancer involving the bone) or any other medicines which may harm your kidneys.
Croatian: • talidomid (lijek za liječenje određenih vrsta raka krvi koji zahvaća kost) ili neke druge lijekove koji mogu oštetiti bubrege
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 od osteonekroze čeljusti.
English: • Sudden coldness with fainting, limpness or collapse.
Croatian: • iznenadan osjećaj hladnoće s nesvjesticom, posrtanjem ili kolapsom.
English: The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2000 ng/ml of zoledronic acid
Croatian: Vezanje za proteine plazme je nisko, s nevezanom frakcijom u rasponu od 60% kod 2 ng/ml do 77% kod 2000 ng/ml zoledronatne kiseline.
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Croatian: U kliničkim je ispitivanjima liječenje zoledronatnom kiselinom nastavljeno tek kad se kreatinin vratio na vrijednosti unutar 10% početne vrijednosti (vidjeti dio 4.4).
English: Dyspnoea, cough, bronchoconstriction
Croatian: dispneja, kašalj, bronhokonstrikcija
English: Thrombocytopenia, leukopenia
Croatian: trombocitopenija, leukopenija
English: Patients received either 4 mg zoledronic acid or placebo every four weeks for one year.
Croatian: Bolesnici su primali zoledronatnu kiselinu u dozi od 4 mg ili placebo svaka četiri tjedna tijekom jedne godine.
English: - Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1 - Breast-feeding (see section 4.6)
Croatian: - Preosjetljivost na djelatnu tvar, druge bisfosfonate ili neku od pomoćnih tvari navedenih u dijelu 6.1 - Dojenje (vidjeti dio 4.6)
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 Accord.
Croatian: • Ako se liječite radi snižavanja količine kalcija u krvi, obično ćete dobiti samo jednu infuziju
English: • 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: • 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
English: Aseptic techniques must be followed during the preparation of the infusion.
Croatian: Tijekom pripreme infuzije moraju se koristiti aseptičke tehnike.
English: Blood creatinine and blood urea increased, hypocalcaemia
Croatian: povišeni kreatinin i urea u krvi, hipokalcemija
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 Accord along with driving and operating of machinery.
Croatian: Nuspojave poput omaglice i pospanosti mogu utjecati na sposobnost upravljanja vozilima i rada na strojevima te je stoga potreban oprez kad se tijekom primanja Zoledronatne kiseline Accord upravlja vozilima i radi sa strojevima.
English: Very common Hypocalcaemia Common:
Croatian: Vrlo često: hipokalcemija Često:
English: • Since no data are available on the compatibility of Zoledronic Acid Accord with other intravenously administered substances, Zoledronic Acid Accord 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 Accord s drugim tvarima za intravensku primjenu, Zoledronatna kiselina Accord se ne smije miješati s drugim lijekovima/tvarima i uvijek se mora primjenjivati kroz zasebnu infuzijsku liniju.
English: 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.
Croatian: Nakon početka infuzije zoledronatne kiseline, koncentracija zoledronatne kiseline u plazmi brzo se povisila i postigla vršnu vrijednost na kraju razdoblja infuzije, nakon čega je uslijedilo brzo sniženje na < 10% vršne vrijednosti nakon 4 sata te < 1% vršne vrijednosti nakon 24 sata, a potom produljeno razdoblje vrlo niskih koncentracija koje nisu prelazile 0,1% vršne vrijednosti prije druge infuzije zoledronatne kiseline 28. dana.
English: Zoledronic Acid Accord contains the same active substance as found in Aclasta (zoledronic acid).
Croatian: Zoledronatnom kiselinom Accord sadrži istu djelatnu tvar koja se nalazi u Aclasti (zoledronatna kiselina).
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 klirens kreatinina < 30 ml/min.
English: • Other medicines that also contain zoledronic acid and are used to treat osteoporosis and other non-cancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic Acid Accord are unknown.
Croatian: • druge lijekove koji također 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 Accord nisu poznati
English: Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja zoledronatne kiseline na životinjama pokazala su da postoji reproduktivna toksičnost (vidjeti dio 5.3).
English: 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).
Croatian: Europska agencija za lijekove je izuzela 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: Following initiation of therapy, serum creatinine should be measured prior to each dose of zoledronic acid and treatment should be withheld if renal function has deteriorated.
Croatian: Nakon početka liječenja kreatinin u serumu treba mjeriti prije primjene svake doze zoledronatne kiseline, a liječenje treba obustaviti ako se funkcija bubrega pogorša.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI ZA SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: • Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Croatian: • nepravilan srčani ritam (fibrilacija atrija) opažen je u bolesnica koje su primale zoledronatnu kiselinu zbog postmenopauzalne osteoporoze.
English: Within three days after zoledronic acid administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Croatian: Tijekom tri dana nakon primjene zoledronatne kiseline često je zabilježena reakcija akutne faze sa simptomima koji uključuju bol u kostima, vrućicu, umor, artralgiju, mialgiju, tresavicu i artritis s posljedičnim oticanjem zglobova; ti se simptomi obično povuku u roku od nekoliko dana (vidjeti opis odabranih nuspojava).
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: 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 Zoledronatnu kiselina.
English: The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Croatian: Vrijeme nastupa je ≤3 dana nakon infuzije Zomete, a reakcija se još zove “sindrom sličan gripi” ili simptomi “nakon doziranja”.
English: Hypophosphataemia 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: hipofosfatemija 1 Nuspojave koje nastaju učestalošću < 5% bile su medicinski procijenjene i pokazalo se da su u skladu s dobro utvrđenim sigurnosnim profilom zoledronatne kiseline (vidjeti dio 4.8).
English: Hypersensitivity reaction
Croatian: reakcija preosjetljivosti
English: Intravenous use after dilution.
Croatian: Primjena u venu nakon razrjeđenja.
English: In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Croatian: U kliničkim se ispitivanjima zoledronatna kiselina primjenjivala istodobno s često davanim antitumorskim lijekovima, diureticima, antibioticima i analgeticima bez klinički vidljivih interakcija.
English: 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.
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: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Croatian: Opažena neravnoteža u ovom ispitivanju nije bila primijećena u drugim ispitivanjima zoledronatne kiseline, uključujući ispitivanja zoledronatne kiseline u dozi od 4 mg primijenjene svaka 3-4 tjedna u onkoloških bolesnika.
English: 5-ml plastic vial made of clear, cycloolefine copolymer with chlorobutyl rubber stopper and aluminium cap with flip-off component.
Croatian: Plastična bočica od 5 ml izrađena od prozirnog cikloolefinskog kopolimera s čepom od klorobutilne gume i aluminijskim poklopcem s „flip-off“ dijelom.
English: During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Croatian: Bolesnicima treba savjetovati da tijekom liječenja bisfosfonatima prijave svaki bol u natkoljenici, kuku ili preponama, i svakog bolesnika s takvim simptomima treba pregledati na nepotpuni prijelom bedrene kosti.
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) svaka 3 mjeseca.
English: • if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic Acid Accord belongs), or any of the other ingredients of this medicine
Croatian: • ako ste alergični (preosjetljivi) na zoledronatnu kiselinu, drugi bisfosfonat (skupina tvari kojoj pripada Zoledronatna kiselina Accord) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • The active substance is zoledronic acid.
Croatian: • Djelatna tvar je zoledronatna kiselina.
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 dvije terapije (zoledronatna kiselina u dozi od 4 mg nasuprot placebu)
English: • Zoledronic Acid Accord must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Croatian: • Zoledronatnu kiselinu Accord smije davati samo zdravstveni djelatnici iskusni u davanju bisfosfonata intravenskim putem, tj. u venu.
English: 4.1 ml for 3.3 mg dose
Croatian: - 4,1 ml za dozu od 3,3 mg
English: Median time to SRE (days)
Croatian: Vrijeme u ispitivanju (tjedni)