natgillin/translations-raw huggingface dataset:
The majority of transaminase elevations were of Grade 1-3 toxicity and resolved upon discontinuation of treatment. 
Većina slučajeva u kojima je zabilježeno povišenje transaminaza bilo je između 1. i 3. stupnja toksičnosti te se povišenje enzima povuklo nakon prestanka primjene lijeka.
If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6). 
Ne smijete primati lijek Daptomicin Hospira: ako ste alergični na daptomicin ili na natrijev hidroksid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
In in vitro studies, daptomycin was not metabolised by human liver microsomes. 
U in vitro ispitivanjima daptomicin se nije metabolizirao putem mikrosoma ljudske jetre.
Therefore, caution is advised when daptomycin is co-administered with any other medicinal product known to reduce renal filtration. 
Stoga se savjetuje oprez pri istodobnoj primjeni daptomicina s bilo kojim lijekom za koji je poznato da smanjuje bubrežnu filtraciju.
Among these failures six patients treated with daptomycin and one patient treated with vancomycin were infected with Staphylococcus aureus that developed increasing MICs of daptomycin on or following therapy (see “Mechanisms of resistance” above). 
Od tih neuspjelih slučajeva, šest bolesnika liječenih daptomicinom i jedan bolesnik liječen vankomicinom imali su infekcije izazvane bakterijom Staphylococcus aureus kod kojih su se tijekom ili nakon terapije povećali MIK-ovi za daptomicin (vidjeti "Mehanizmi rezistencije" gore).
The volume of distribution at steady state of daptomycin in healthy adult subjects was approximately 0.1 l/kg and was independent of dose. 
Volumen distribucije daptomicina u stanju dinamičke ravnoteže bio je u zdravih odraslih dobrovoljaca otprilike 0,1 l/kg te je bio neovisan o dozi.
For example, patients with any degree of renal impairment (creatinine clearance <80 ml/min; see also section 4.2), including those on haemodialysis or CAPD, and patients taking other medicinal products known to be associated with myopathy (e.g. HMG-CoA reductase inhibitors, fibrates and ciclosporin). 
Među te bolesnike ubrajaju se oni s bilo kojim stupnjem oštećenja bubrega (klirens kreatinina < 80 ml/min; vidjeti također dio 4.2), uključujući one na hemodijalizi ili kontinuiranoj ambulantnoj peritonejskoj dijalizi (CAPD), kao i bolesnici koji uzimaju druge lijekove za koje se zna da su povezani s miopatijom (npr. inhibitori HMG-CoA reduktaze, fibrati i ciklosporin).
Tell a doctor or a nurse straight away if you experience symptoms suggestive of allergic reaction, such as wheezing, difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever (see section 4 of this leaflet for more information). 
Odmah obavijestite liječnika ili medicinsku sestru ako Vam se pojave simptomi koji upućuju na alergijsku reakciju, poput piskanja, otežanog disanja, oticanje lica, vrata ili grla, osipa i koprivnjače, vrućice (za više podataka vidjeti dio 4 ove upute).
Therefore it is important that your doctor takes into account that you are receiving Daptomycin Hospira. 
Stoga je važno da liječnik zna da primate lijek Daptomicin Hospira.
False prolongation of prothrombin time (PT) and elevation of international normalised ratio (INR) have been observed when certain recombinant thromboplastin reagents are utilised for the assay (see section 
Lažno produljenje protrombinskog vremena (PV) i povećanje internacionalnog normaliziranog omjera (INR) zabilježeni su kada se određeni rekombinantni tromboplastinski reagensi koriste u testu (vidjeti također dio 4.5).
Daptomycin Hospira is therefore not indicated for the treatment of pneumonia. 
Stoga lijek Daptomicin Hospira nije indiciran za liječenje pneumonije.
Single use 10 ml type I clear glass vials with gray rubber closure and aluminium cap. 
Prozirne staklene bočice (staklo tip I) od 10 ml, za jednokratnu upotrebu, sa sivim gumenim čepom i aluminijskom kapicom.
If unexplained abnormalities of PT/INR are observed in patients taking daptomycin, consideration should be given to a possible in vitro interaction with the laboratory test. 
Ako se u bolesnika koji primaju daptomicin uoče neobjašnjivi poremećaji vrijednosti PV/INR, potrebno je razmotriti moguću in vitro interakciju u laboratorijskoj pretrazi.
In the paediatric SAB study, the mean duration of IV Daptomycin Hospira was 12 days, with a range of 1 to 44 days. 
U pedijatrijskom SAB ispitivanju, srednja vrijednost trajanja liječenja lijekom Daptomycin Hospira primjenjenog intravenski, iznosila je 12 dana, s rasponom od 1 do 44 dana.
Deep-seated infections 
Duboko smještene infekcije
The key efficacy endpoint was the sponsor-defined clinical outcome at test-of-cure (TOC), which was defined by a blinded medical director. 
Ključna mjera ishoda djelotvornosti bio je klinički ishod prema definiciji naručitelja ispitivanja kod utvrđivanja izlječenja (engl. test-of-cure, TOC), koji je definirao medicinski direktor koji nije bio upoznat s informacijama o ispitanicima.
Failures with daptomycin in the treatment of enterococcal infections that were mostly accompanied by bacteraemia have been reported. 
Zabilježeni su neuspjesi s daptomicinom u liječenju enterokoknih infekcija koje su većinom bile praćene bakterijemijom.
Creatine phosphokinase and myopathy Increases in plasma creatine phosphokinase (CPK; MM isoenzyme) levels associated with muscular pains and/or weakness and cases of myositis, myoglobinaemia and rhabdomyolysis have been reported during therapy with daptomycin (see also sections 4.5, 4.8 and 5.3). 
Kreatin fosfokinaza i miopatija Tijekom terapije daptomicinom zabilježeni su porasti razina kreatin fosfokinaze (CPK; MM izoenzim) u plazmi, povezani s bolovima i/ili slabošću mišića, kao i slučajevi miozitisa, mioglobinemije i rabdomiolize (vidjeti također dijelove 4.5, 4.8 i 5.3).
The site of metabolism has not been identified. 
Metabolički put nije utvrđen.
In a single human case study, daptomycin was intravenously administered daily for 28 days to a nursing mother at a dose of 500 mg/day, and samples of the patient's breast milk were collected over a 24-hour period on day 27. 
Tijekom ispitivanja pojedinačnog slučaja daptomicin je primjenjivan intravenski svaki dan tijekom 28 dana u dozi od 500 mg/dan majci koja je dojila, a 27. dana prikupljeni su uzorci izdojenog mlijeka bolesnice tijekom razdoblja od 24 sata.
Following intravenous administration, plasma clearance of daptomycin is approximately 7 to 9 ml/h/kg and its renal clearance is 4 to 7 ml/h/kg. 
Nakon intravenske primjene, klirens daptomicina iz plazme iznosi otprilike 7 do 9 ml/h/kg, a bubrežni klirens iznosi 4 do 7 ml/h/kg.
Experience with the concomitant administration of daptomycin and warfarin is limited. 
Ograničena su iskustva s istodobnom primjenom daptomicina i varfarina.
Powder for solution for injection/infusion 1 vial 
Prašak za otopinu za injekciju/infuziju 1 bočica
This results in bacterial cell death with negligible cell lysis. 
Ishod je smrt bakterijske stanice uz zanemarivu lizu stanice.
Eosinophilic pneumonia has been reported in patients receiving daptomycin (see section 4.8). 
Eozinofilna pneumonija prijavljena je u bolesnika koji su dobivali daptomicin (vidjeti dio 4.8).
The lowest observable effect level (LOEL) for myopathy in rats and dogs occurred at exposure levels of 0.8 to 2.3-fold the human therapeutic levels at 6 mg/kg (30-minute intravenous infusion) for patients with normal renal function. 
Lowest Observable Effect Level, LOEL) za miopatiju se u štakora i pasa javila pri razinama izloženosti od 0,8 do 2,3 puta većim od terapijskih razina u ljudi uz 6 mg/kg (30-minutna intravenska infuzija) u bolesnika s urednom funkcijom bubrega.
Anticoagulant activity in patients receiving daptomycin and warfarin should be monitored for the first several days after therapy with Daptomycin Hospira is initiated. 
U bolesnika koji primaju daptomicin i varfarin potrebno je pratiti antikoagulantnu aktivnost tijekom prvih nekoliko dana nakon uvođenja terapije lijekom Daptomicin Hospira.
Please inform your doctor that you are on treatment with Daptomycin Hospira. 
Obavijestite svog liječnika da se liječite lijekom Daptomicin Hospira.
Relative to non-obese subjects daptomycin systemic exposure measured by AUC was about 28% higher in moderately obese subjects (Body Mass Index of 25-40 kg/m2) and 42% higher in extremely obese subjects 
U usporedbi s ispitanicima koji nisu bili pretili, sustavna izloženost daptomicinu mjerena pomoću AUC bila je za oko 28% veća u umjereno pretilih ispitanika (indeks tjelesne mase 25-40 kg/m2) a 42%
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. 
Po potrebi, kada je lokalna prevalencija rezistencije takva da je opravdanost primjene lijeka barem u nekim vrstama infekcija upitna, potrebno je zatražiti stručni savjet.
If you experience these symptoms, tell your doctor or nurse straight away. 
Ukoliko Vam se pojave ovi simptomi, odmah obavijestite svog liječnika ili medicinsku sestru.
The most common type of infection treated was wound infection (38% of patients), while 21% had major abscesses. 
(38% bolesnika), dok je 21% imalo velike apscese.
1 to <2 years (N=30) 
1 do <2 godina (N=30)
In a mass balance study using radiolabelled material, 78% of the administered dose was recovered from the urine based on total radioactivity, whilst urinary recovery of unchanged daptomycin was approximately 50% of the dose. 
U ispitivanju masene ravnoteže pomoću radioaktivno obilježenog materijala, temeljeno na ukupnoj radioaktivnosti, 78% primijenjene doze nađeno je u mokraći, dok je otprilike 50% doze nađeno u mokraći u obliku nepromijenjenog daptomicina.
This dose is given directly into the blood stream (into a vein), as an infusion lasting about 30-60 minutes. 
Ova doza se daje izravno u krvotok (u venu) u obliku infuzije u trajanju od 30 do 60 minuta.
- It cannot be ruled out that those patients with CPK greater than 5 times upper limit of normal at baseline may be at increased risk of further increases during daptomycin therapy. 
- U bolesnika s početnom vrijednošću CPK 5 puta većom od gornje granice normale ne može se isključiti povećan rizik od daljnjih porasta tijekom terapije daptomicinom.
Limb pain, serum creatine phosphokinase (CPK) increased 
Bolovi u ekstremitetima, povišenje razine kreatin fosfokinaze u serumu (CPK)
Other medicines and Daptomycin Hospira Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. 
Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
The microbiological outcome at TOC for the daptomycin and SOC treatment arms for infections caused by MRSA and MSSA are presented in the table below (mMITT population). 
Mikrobiološki ishod kod utvrđivanja izlječenja infekcija uzrokovanih MRSA ili MSSA u skupinama liječenima daptomicinom i standardnom skrbi prikazan je u tablici niže (mMITT populacija).
Concomitant administration of probenecid and daptomycin has no effect on daptomycin pharmacokinetics in humans suggesting minimal to no active tubular secretion of daptomycin. 
Istodobna primjena probenecida i daptomicina ne utječe na farmakokinetiku daptomicina u ljudi, što ukazuje da je aktivna tubularna sekrecija daptomicina minimalna ili je uopće nema.
Recurrence of eosinophilic pneumonia upon re-exposure has been reported. 
Nakon ponovnog uvođenja lijeka prijavljena je ponovna pojava eozinofilne pneumonije.
Therefore, until more experience is gained, breast-feeding should be discontinued when daptomycin is administered to nursing women. 
Stoga, dok se ne bude raspolagalo većim brojem podataka, treba prekinuti dojenje ukoliko se daptomicin primjenjuje u dojilja.
Following administration of a single 4 mg/kg intravenous dose of daptomycin over a 30-minute period, the mean total clearance of daptomycin was approximately 35% lower and the mean AUC0-∞ was approximately 58% higher in elderly subjects (≥ 75 years of age) compared with those in healthy young subjects (18 to 30 years of age). 
Nakon jednokratne primjene daptomicina u dozi od 4 mg/kg intravenski tijekom 30 minuta prosječni ukupni klirens daptomicina bio je otprilike 35% manji, a prosječni AUC0-∞ bio je otprilike 58% veći u starijih ispitanika (≥ 75 godina starosti) u usporedbi sa skupinom mladih zdravih ispitanika (18 do 30 godina starosti).
Less frequently reported, but more serious, adverse reactions include hypersensitivity reactions, eosinophilic pneumonia (occasionally presenting as organising pneumonia), drug rash with eosinophilia and systemic symptoms (DRESS), angioedema and rhabdomyolysis. 
Manje učestale, ali ozbiljnije nuspojave, uključuju reakcije preosjetljivosti, eozinofilnu pneumoniju (koja se povremeno manifestira kao organizirana pneumonija), osip uzrokovan lijekom uz eozinofiliju i sistemske simptome (DRESS), angioedem i rabdomiolizu.
Your doctor will check the condition of your lungs and decide whether or not you should continue Daptomycin Hospira treatment. 
Liječnik će Vam pregledati pluća te će odlučiti trebate li nastaviti liječenje lijekom Daptomicin Hospira ili ne.
Daptomycin Hospira vials are for single-use only. 
Bočice lijeka Daptomicin Hospira isključivo su za jednokratnu uporabu.
What Daptomycin Hospira is and what it is used for 
Hospira i za što se koristi
Simulation using a population pharmacokinetic model demonstrated that the AUCss (area under the concentration-time curve at steady state) of daptomycin in paediatric patients 1 to <2 years of age receiving12 mg/kg once daily would be comparable to that in adult patients receiving 6 mg/kg once daily. 
Simulacija korištenjem modela populacijske farmakokinetike pokazala je da bi AUCss (površina ispod krivulje u stanju mirovanja) daptomicina u pedijatrijskih bolesnika u dobi od 1 do <2 godine koji su primali 12 mg/kg na dan bio usporediv s onim primijećenim u odraslih bolesnika koja su primali 6 mg/kg na dan.
However, no dose adjustment is considered to be necessary based on obesity alone. 
Međutim, smatra se da samo zbog pretilosti dozu ne treba prilagođavati.
The pharmacokinetics of daptomycin in paediatric subjects was evaluated in 3 single-dose pharmacokinetic studies. 
Farmakokinetika daptomicina u pedijatrijskih ispitanika bila je procijenjena u 3 farmakokinetička ispitivanja primjene jednokratne doze.
The pharmacokinetics of daptomycin in patients with severe hepatic impairment (Child-Pugh C classification) have not been evaluated. 
Farmakokinetika daptomicina u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) nije ispitivana.
Excretion of daptomycin into milk of lactating animals has not been studied. 
Izlučivanje daptomicina u mlijeko životinja za vrijeme laktacije nije ispitivano.
Animal studies showed that daptomycin is not absorbed to any significant extent after oral administration. 
Ispitivanja na životinjama pokazala su da se daptomicin nakon peroralne primjene ne apsorbira u značajnoj mjeri.
The interaction between daptomycin and tobramycin with an approved dose of daptomycin is unknown. 
Nisu poznate interakcije daptomicina i tobramicina tijekom primjene daptomicina u odobrenoj dozi.
The efficacy of daptomycin in patients with prosthetic valve infections or with left-sided infective endocarditis due to Staphylococcus aureus has not been demonstrated. 
Djelotvornost daptomicina u bolesnika s infekcijama umjetnih zalistaka ili s lijevostranim infektivnim endokarditisom izazvanim bakterijom Staphylococcus aureus nije dokazana.
Important: Please refer to the Summary of Product Characteristics before prescribing. 
Važno: Prije propisivanja pročitati sažetak opisa svojstava lijeka.
Sodium hydroxide Citric acid 
natrijev hidroksid citratna kiselina
The possibility of erroneous results may be minimised by drawing samples for PT or INR testing near the time of trough plasma concentrations of daptomycin (see section 
Mogućnost dobivanja pogrešnih rezultata može se smanjiti tako da se uzorci za određivanje PV ili INR uzmu u vrijeme kada su koncentracije daptomicina u plazmi najniže (vidjeti dio 4.4).
Not known*: Acute generalised exanthematous pustulosis 
Akutna generalizirana egzantematozna pustuloza
Daptomycin should not be administered as a 2-minute injection to paediatric patients. 
Daptomicin se ne smije primijeniti kao 2-minutna injekcija pedijatrijskim bolesnicima.
If this applies to you, tell your doctor or nurse. 
Ako se to odnosi na Vas, obavijestite svog liječnika ili medicinsku sestru.
Hospira UK Limited Horizon 
Hospira UK Ltd Horizon
There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes. 
Ne postoji kliničko iskustvo u bolesnika s primjenom daptomicina putem injekcije tijekom 2 minute.
In adults, daptomycin is given by intravenous infusion (see section 6.6) and administered over a 30-minute period or by intravenous injection (see section 6.6) and administered over a 2-minute period. 
U odraslih se daptomicin daje intravenskom infuzijom (vidjeti dio 6.6) koja se primjenjuje u trajanju od 30 minuta ili intravenskom injekcijom (vidjeti dio 6.6) koja se primjenjuje u trajanju od 2 minute.
Gender No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed. 
Spol Nisu uočene klinički značajne razlike u farmakokinetici daptomicina s obzirom na spol.
In addition, regular monitoring of renal function is advised during concomitant administration of potentially nephrotoxic agents, regardless of the patient's pre-existing renal function (see section 4.5). 
Osim toga, tijekom istodobne primjene potencijalno nefrotoksičnih lijekova savjetuje se redovito praćenje bubrežne funkcije, bez obzira na prethodnu bubrežnu funkciju bolesnika (vidjeti također dio
Modified intent-to-treat Clinically evaluable Microbiologically evaluable (ME) 
Microbiologically evaluable, ME)
Studies of daptomycin with anticoagulants other than warfarin have not been conducted. 
Nisu provedena ispitivanja istodobne primjene daptomicina i drugih antikoagulansa osim varfarina.
Daptomycin Hospira should only be reconstituted with sodium chloride 9 mg/ml (0.9%). 
Daptomicin Hospira smije se rekonstituirati samo s otopinom natrijevog klorida 9 mg/ml (0,9%).
The pharmacokinetics of daptomycin is not altered in subjects with moderate hepatic impairment (Child-Pugh B classification of hepatic impairment) compared with healthy volunteers matched for gender, age and weight following a single 4 mg/kg dose. 
Farmakokinetika daptomicina u ispitanika s umjerenim oštećenjem jetre (Child-Pugh stadij B oštećenja jetre), nakon primjene jednokratne doze od 4 mg/kg, nije se promijenila u usporedbi s onom u zdravih dobrovoljaca istog spola, dobi i tjelesne težine.
Daptomycin was not mutagenic or clastogenic in a battery of in vivo and in vitro genotoxicity tests. 
Daptomicin se nije pokazao mutagenim ni klastogenim pomoću kompleta testova za ispitivanje genotoksičnosti in vivo i in vitro.
Clinical studies in patients employed infusion of daptomycin over at least 30 minutes. 
U kliničkim ispitivanjima u bolesnika primjenjivana je infuzija daptomicina tijekom najmanje 30 minuta.
What Daptomycin Hospira is and what it is used for What you need to know before you are given Daptomycin Hospira How Daptomycin Hospira is given Possible side effects 
Što je Daptomicin Hospira i za što se koristi Što morate znati prije nego počnete primati Daptomicin Hospira
The Marketing Authorisation Holder shall ensure that all laboratories expected to perform Daptomycin Hospira susceptibility testing are provided with: - Summary of Product Characteristics - Laboratory susceptibility testing leaflet 
Nositelj odobrenja osigurat će da svi laboratoriji za koje se očekuje da će izvoditi testove osjetljivosti na lijek Daptomicin Hospira dobiju: - sažetak opisa svojstava lijeka, - letak za laboratorije vezano uz testiranje osjetljivosti.
(Body Mass Index of >40 kg/m 2). 
veća u ekstremno pretilih ispitanika (indeks tjelesne mase > 40 kg/m 2).
Uncommon: Supraventricular tachycardia, extrasystole 
Supraventrikularna tahikardija, ekstrasistole
Following administration of a single 4 mg/kg or 6 mg/kg intravenous dose of daptomycin over a 30-minute period to adult subjects with various degrees of renal impairment, total daptomycin clearance (CL) decreased and systemic exposure (AUC) increased as renal function (creatinine clearance) decreased. 
Nakon primjene jednokratne intravenske doze daptomicina od 4 mg/kg ili 6 mg/kg tijekom 30 minuta odraslim ispitanicima s različitim stupnjevima oštećenja bubrega, ukupni se klirens daptomicina (CL) smanjivao, a sistemska izloženost (AUC) se povećavala kako se pogoršavala funkcija bubrega (smanjivao se klirens kreatinina).
Using a new syringe, insert the needle into the inverted vial. 
Koristeći novu štrcaljku umetnuti iglu u preokrenutu bočicu.
- That daptomycin susceptibility testing needs Ca in the testing medium and testing methods with mediums providing consistent Ca concentrations are recommended. 
Kod testiranja osjetljivosti na daptomicin potrebna je prisutnost kalcija u mediju za testiranje i preporučuju se metode ispitivanja kod kojih je koncentracija kalcija u mediju stalna.
- Adult and paediatric (1 to 17 years of age) patients withStaphylococcus aureus bacteraemia (SAB). 
- Odrasli i pedijatrijski bolesnici (u dobi od 1 do 17 godina) sa Staphylococcus aureus bakterijemijom (SAB).
The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes. 
Rekonstituirana i razrijeđena otopina se zatim treba primijeniti putem intravenske infuzije tijekom 30 ili 60 minuta.
In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 minutes (see sections 4.2 and 5.2). 
U pedijatrijskih bolesnika mlađih od 7 godina koji primaju dozu od 9-12 mg/kg, daptomicin treba primijeniti tijekom 60 minuta (vidjeti dijelove 4.2 i 5.2).
The differences noted are most likely due to the normal reduction in renal function observed in the geriatric population. 
Uočene razlike su najvjerojatnije posljedica fiziološkog smanjenja bubrežne funkcije u starijoj populaciji.
Not known*: Eosinophilic pneumonia 1**, cough 
Eozinofilna pneumonija 1**, kašalj
Creatine phosphokinase (CPK) levels must be measured at baseline and at regular intervals (at least weekly) during treatment (see section 4.4). 
Razine kreatin fosfokinaze (CPK) moraju se mjeriti na početku i u redovitim razmacima (barem svakog tjedna) tijekom liječenja (vidjeti dio 4.4).
If CDAD is suspected or confirmed, daptomycin may need to be discontinued and appropriate treatment instituted as clinically indicated. 
Ako se posumnja ili potvrdi proljev povezan s bakterijom Clostridium difficile, možda će biti potrebno prekinuti liječenje daptomicinom te uvesti odgovarajuće klinički indicirano liječenje.
- Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). 
- Odrasli i pedijatrijski bolesnici (u dobi od 1 do 17 godina) bolesnici s kompliciranim infekcijama kože i mekih tkiva.
In adult patients, this dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes. 
U odraslih bolesnika, ta doza se daje izravno u krvotok (u venu) ili u obliku infuzije koja traje oko 30 minuta ili u obliku injekcije koja traje oko 2 minute.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe/use Daptomycin Hospira are provided with: - Summary of Product Characteristics - Dosage card 
Nositelj odobrenja osigurat će da svi liječnici za koje se očekuje da će propisivati/primjenjivati lijek Daptomicin Hospira dobiju sljedeće: - sažetak opisa svojstava lijeka, - karticu za doziranje.
For the 2-minute intravenous injection, the storage time of the reconstituted solution in the vial (see section 6.6) at 25°C must not exceed 12 hours (or 48 hours at 2°C-8°C). 
Za 2-minutnu intravensku injekciju, vrijeme čuvanja rekonstituirane otopine u bočici (vidjeti dio 6.6) pri 25°C ne smije prelaziti 12 sati (ili 48 sati pri 2°C - 8°C).