natgillin/translations-raw huggingface dataset:
In newly diagnosed and relapsed/refractory APL patients who develop sustained leukocytosis after initiation of therapy, hydroxyurea should be administered. 
a koji su razvili trajnu leukocitozu nakon započinjanja terapije potrebno je primijeniti hidroksiureju.
Treatment with arsenic trioxide must be temporarily interrupted before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed and judged to be possibly related to Arsenic trioxide treatment. 
Liječenje arsenovim trioksidom mora se privremeno prekinuti prije planiranog kraja terapije u bilo kojem trenutku ako se primijeti toksičnost 3. stupnja ili veća prema Zajedničkim kriterijima toksičnosti američkog Nacionalnog instituta za rak te procijeni da su toksični učinci možda povezani s liječenjem arsenovim trioksidom.
Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion 
Arsenov trioksid Accord 1 mg/ml koncentrat za otopinu za infuziju
Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with Arsenic trioxide, caution is advised in the use of Arsenic trioxide in patients with hepatic impairment (see section 4.4 and 4.8). 
S obzirom da ni za jednu skupinu s oštećenjem jetre nema dostupnih podataka, a hepatotoksični učinci se mogu pojaviti tijekom liječenja arsenovim trioksidom, potreban je oprez kod primjene arsenovog trioksida u bolesnika s oštećenjem jetre (vidjeti dio 4.4 i 4.8).
In the multicentre study 27 of 40 patients were alive with a median follow-up time of 16 months (range 9 to 25). 
U monocentričnom ispitivanju preživjelo je 27 od 40 bolesnika s medijanom vremena kontrole od
Medicinal products known to cause hepatotoxic effects Hepatotoxic effects may occur during the treatment with arsenic trioxide, caution is advised when arsenic trioxide is coadministered with other medicinal products known to cause hepatotoxic effects (see section 4.4 and 4.8). 
Tijekom liječenja arsenovim trioksidom mogu se pojaviti hepatotoksični učinci; potreban je oprez kada se arsenov trioksid primjenjuje istodobno s drugim lijekovima za koje je poznato da imaju hepatotoksične učinke (vidjeti dijelove 4.4 i 4.8).
hours after first administration of arsenic trioxide), but due to their longer half-life, accumulate more upon multiple dosing than does AsIII. 
Pentavalentni metaboliti MMAV i DMAV, sporo se pojavljuju u plazmi (približno 10-24 sata nakon prve primjene arsenovog trioksida), ali zbog njihova duljeg poluvremena, akumuliraju se više nakon višestrukog doziranja nego AsIII.
Leukocytosis occurred in 50% of patients with relapsed/refractory APL, as determined by haematology assessments. 
Leukocitoza se pojavila u 50% bolesnika s APL-om koji je bio u fazi relapsa/refraktoran na liječenje,
Not known (frequency cannot be estimated from the available data): - lung infection, infection in the blood - inflammation of the lungs which causes chest pain and breathlessness, cardiac failure - dehydration, confusion 
- crvenilo kože, natečeno lice, zamućeni vid Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): - infekcija pluća, infekcija u krvi - upala pluća koja uzrokuje bol u prsima i nedostatak zraka, zatajenje srca
Undesirable effects are listed in table 2 below as MedDRA preferred term by system organ class and frequencies observed during arsenic trioxide clinical trials in 52 patients with refractory/relapsed 
preporučenim izrazima, prema klasi organskih sustava i učestalosti primijećenoj tijekom liječenja arsenovim trioksidom u kliničkim ispitivanjima na 52 bolesnika s APL-om u refraktornoj fazi/relapsu.
Since no data are available across all renal impairment groups, caution is advised in the use of Arsenic trioxide in patients with renal impairment. 
S obzirom da ni za jednu skupinu s oštećenjem bubrega nema dostupnih podataka, potreban je oprez kod primjene arsenovog trioksida u bolesnika s oštećenjem bubrega.
The active ingredient of Arsenic trioxide Accord, arsenic trioxide, is a human carcinogen. 
Djelatna tvar lijeka Arsenov trioksid Accord, arsenov trioksid, kancerogen je za ljude.
There are no studies in pregnant women using arsenic trioxide. 
Ispitivanja na trudnicama koje su uzimale arsenov trioksid nisu provedena.
Treatment with arsenic trioxide must be temporarily interrupted before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed and judged to be possibly related to arsenic trioxide treatment (see section 4.2). 
Odgoda i prilagodba doze Liječenje arsenovim trioksidom mora se privremeno prekinuti prije planiranog kraja terapije u bilo kojem trenutku ako se primijeti toksičnost 3. stupnja ili veća prema Zajedničkim kriterijima toksičnosti američkog Nacionalnog instituta za rak te procijeni da su toksični učinci možda povezani s liječenjem arsenovim trioksidom (vidjeti dio 4.2).
3/µl 
9/l.
Patients in the ATRA+ arsenic trioxide treatment group received oral ATRA at 45 mg/m2 daily and iv arsenic trioxide at 0.15 mg/kg daily until CR. 
Bolesnici u skupini liječenoj kombinacijom ATRA+ arsenov trioksid primali su kroz usta ATRA u dozi 45 mg/m2 dnevno, a u venu arsenov trioksid u dozi 0,15 mg/kg dnevno do potpune remisije.
In clinical trials, in the relapsed/refractory setting, 40% of patients treated with arsenic trioxide experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after arsenic trioxide infusion, and then returned to baseline by the end of 8 weeks after arsenic trioxide infusion. 
U kliničkim ispitivanjima bolesti u fazi relapsa/refraktorne na liječenje, 40% bolesnika liječenih arsenovim trioksidom iskusilo je najmanje jedan korigirani produžetak QT (QTc) intervala veći od 500 ms.
If your disease responds to Arsenic trioxide Accord, you will be given a second treatment cycle of 25 doses given 5 days per week (followed by 2 days interruption) for 5 weeks. 
Arsenov trioksid Accord, započet ćete drugi ciklus liječenja od 25 doza koje se daju 5 dana u tjednu
Arsenic trioxide Accord contains sodium 
Lijek Arsenov trioksid Accord sadrži natrij
Use of Arsenic trioxide Accord 
Uporaba lijeka Arsenov trioksid Accord
If symptoms suggestive of serious acute arsenic toxicity (e.g. convulsions, muscle weakness and confusion) appear, arsenic trioxide must be immediately discontinued and chelating therapy with penicillamine at a daily dose ≤ 1 gm per day may be considered. 
konvulzije, slabosti u mišićima i konfuzija), mora se odmah prekinuti primjenu arsenovog trioksida i razmotriti primjenu kelirajućih agensa s penicilaminom pri dnevnoj dozi od ≤ 1 mg na dan.
• Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene. 
a koja je karakterizirana prisutnošću translokacije t(15;17) i/ili prisutnošću gena za alfa receptor za promijelocitnu leukemiju/retinoatnu kiselinu (PML/RAR-alfa).
Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion arsenic trioxide 
Arsenov trioksid Accord 1 mg/ml koncentrat za otopinu za infuziju arsenov trioksid
Very common (may affect more than 1 in 10 people): - fatigue (weariness), pain, fever, headache - nausea, vomiting, diarrhoea - dizziness, muscle pain, numbness or tingling - rash or itching, increased blood sugar, oedema (swelling due to excess fluid) - shortness of breath, fast heart beat, abnormal ECG heart tracing - reduced potassium or magnesium in the blood, liver function tests abnormal including presence of excess bilirubin or gamma-glutamyltransferase in the blood 
- umor (klonulost), bol, vrućica, glavobolja - mučnina, povraćanje, proljev - omaglica, bolovi u mišićima, obamrlost ili trnci - osip ili svrbež, povećana razina šećera u krvi, oticanje (oteklina zbog viška tekućine) - nedostatak zraka, ubrzani srčani otkucaji, poremećeni EKG nalaz srca
The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products, a history of torsade de pointes, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalaemia or hypomagnesaemia. 
Rizik od torsade de pointes povezan je sa stupnjem produljenja QT intervala, istodobnom primjenom lijekova koji produljuju QT interval, anamnezom torsade de pointes, postojećim prethodnim produljenjem QT
How to store Arsenic trioxide Accord 
Kako primjenjivati Arsenov trioksid Accord
Ventricular tachycardia 
Srčani poremećaji tahikardija
Arsenic trioxide Accord must be diluted with 100 to 250 ml of glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection immediately after withdrawal from the vial. 
50 mg/ml (5%) ili otopine natrijeva klorida 9 mg/ml (0,9%) za injekciju odmah nakon izvlačenja lijeka iz bočice.
Electrocardiogram QT prolonged 
produljenje QT intervala elektrokardiograma
Patients with hepatic impairment Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with arsenic trioxide caution is advised in the use of arsenic trioxide in patients with hepatic impairment (see section 4.4 on hepatotoxicity and section 4.8). 
S obzirom da ni za jednu skupinu s oštećenjem jetre nema dostupnih podataka, a hepatotoksični učinci se mogu pojaviti tijekom liječenja arsenovim trioksidom, potreban je oprez kod primjene arsenovog trioksida u bolesnika s oštećenjem jetre (vidjeti dio 4.4 o hepatotoksičnosti i dio 4.8).
Because of the potential for serious adverse reactions in breastfeeding infants from arsenic trioxide, breast-feeding must be discontinued prior to and throughout administration. 
Prije i tijekom primjene arsenovog trioksida mora se prekinuti dojenje zbog mogućnosti nastanka ozbiljnih nuspojava u dojenčadi.
If you experience discomfort or if you feel unwell after a Arsenic trioxide Accord injection, you should wait until the symptoms go away before driving or using machines. 
Ako osjetite nelagodu ili Vam se ne osjećate dobro nakon injekcije lijeka Arsenov trioksid Accord,
If your disease responds to Arsenic trioxide Accord, you will be given 4 additional treatment cycles of 20 doses given 5 days per week (followed by 2 days interruption) for 4 weeks followed by 4 weeks interruption. 
Svaki ciklus sastoji se od 20 doza koje se daju 5 dana u tjednu (nakon čega slijedi 2 dana pauze) tijekom 4 tjedna, nakon čega slijedi pauza od 4 tjedna.
• Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/µl) in combination with all-trans-retinoic acid (ATRA) 
(broj bijelih krvnih stanica ≤ 10 x 103/µl) u kombinaciji sa sve-trans-retinoatnom kiselinom
After first opening Once opened the product should be used immediately. 
Lijek se mora upotrijebiti odmah nakon otvaranja.
Negative Positive Not evaluable 
Nepoznato* Nepoznato*
Respiratory, thoracic and mediastinal disorders 
Poremećaji dišnog sustava, prsišta i sredoprsja sindrom diferencijacije
Absent Present Not evaluable 
Ne može se procijeniti
In a phase 3, multicenter, noninferiority trial comparing all-trans-retinoic acid (ATRA) plus chemotherapy with ATRA plus arsenic trioxide in newly diagnosed low-to-intermediate risk APL patients (Study APL0406; see also section 5.1), serious adverse reactions including hepatic toxicity, thrombocytopenia, neutropenia and QTc prolongation were observed in patients treated with arsenic trioxide. 
U multicentričnom ispitivanju neinferiornosti faze 3 u kojem je uspoređena primjena kombinacije sve-trans-retinoatne kiseline (ATRA) i kemoterapije s primjenom kombinacije ATRA-e i arsenovog trioksida u novodijagnosticiranih bolesnika s APL-om niskog do srednjeg rizika (ispitivanje APL0406;
Fertility studies have not been conducted with arsenic trioxide. 
S arsenovim trioksidom nisu provedena ispitivanja plodnosti.
Confusional state 
Psihijatrijski poremećaji konfuzno stanje
Common (may affect up to 1 in 10 people): - reduction in blood cell counts (platelets, red and/or white blood cells), increased white blood cells - chills, increased weight - a fever due to an infection and low levels of white blood cells, herpes zoster infection - chest pain, bleeding in the lung, hypoxia (low oxygen level), collection of fluid around the heart or the lung, low blood pressure, abnormal heart rhythm - fit, joint or bone pain, inflammation of the blood vessels - increased sodium or magnesium, ketones in the blood and urine (ketoacidosis), renal function tests abnormal, kidney failure - stomach (abdominal) ache - redness of the skin, swollen face, blurred vision 
- vrućica zbog infekcije i niskih razina bijelih krvnih stanica, infekcija herpesom zosterom - bolovi u prsima, krvarenje u plućima, hipoksija (niska razina kisika), nakupljanje tekućine oko srca ili pluća, nizak krvni tlak, poremećeni srčani ritam
Arsenic trioxide Accord contains sodium: 
Lijek Arsenov trioksid Accord sadrži natrij.
In newly diagnosed patients, with low to intermediate risk APL, QTc prolongation was observed in 15.6 %. 
Među novodijagnosticiranim bolesnicima s APL-om niskog do srednjeg rizika, njih 63,2% razvilo je
Dilution of Arsenic trioxide Accord 
Razrjeđivanje lijeka Arsenov trioksid Accord
Pyrexia 
RMP-a.
Pneumonitis 
FARMACEUTSKI
Oedema 
Prisutno
Lymphopenia 
BOČICA
This event is called extravasation. 
Taj se događaj naziva ekstravazacija.
The infusion will last 1-2 hours. 
Infuzija će trajati 1-2 sata.
• Infection (after an operation or other infections) 
• Infekcija (nakon operacije ili druge infekcije)
Both of these effects are expected for this class of compound. 
Oba ova učinka očekivana su za ovu skupinu spojeva.
Powder and solvent: 3 years. 
Prašak i otapalo: 3 godine.
CTC grade 3-4 
CTC stupanj 3-4
If you receive more Savene than you should 
Ako primite više lijeka Savene nego što ste trebali
It is a serious complication as it can cause severe tissue damage. 
To je ozbiljna komplikacija jer može izazvati teško oštećenje tkiva.
Date of latest renewal: 18 July 2011 
Datum posljednje obnove odobrenja: 18. srpnja 2011.
All adverse reactions have been rapidly reversible. 
Sve nuspojave su brzo reverzibilne.
Total urinary recovery of unchanged dexrazoxane is 34-60 %. 
Ukupni postotak urinarnog povrata nepromijenjenog deksrazoksana je 34-60%.
• Changes in liver function (these may be seen in test results) 
• Promjene u funkciji jetre (mogu se vidjeti u nalazima pretraga)
In both studies the dosage regimen was the same. 
U oba je ispitivanja režim doziranja bio isti.
Treatment Day 2 and Day 3 should start at the same hour (+/- 3 hours) as Day 1. 
Liječenje drugog i trećeg dana treba započeti u isti sat (+/- 3 sata) kao i prvi dan.
Some side effects can be serious and need immediate medical attention. 
Neke nuspojave mogu biti ozbiljne i zahtijevaju trenutnu medicinsku pažnju.
Your doctor will calculate your body surface area in square meter (m2) to determine the dose you should receive. 
Liječnik će izračunati Vašu površinu tijela u četvornim metrima (m2) kako bi odredio dozu koju trebate primati.
Savene will not be used again at the time of your next anthracycline cycle, except if extravasation occurs again. 
Savene se neće ponovno davati prilikom Vašeg sljedećeg ciklusa antraciklina, osim ako ponovno dođe do ekstravazacije.
The dose will depend on your height, weight and kidney function. 
Doza ovisi o Vašoj visini, težini i funkciji bubrega.
None of the patients required surgical intervention. 
Nitko od bolesnika nije trebao kiruršku intervenciju.
The toxicity in combination with doxorubicin was additive and not synergistic. 
Toksičnost u kombinaciji s doksorubicinom bila je aditivna, a ne sinergistička.
It contains no antibacterial preservative. 
Ne sadrži antibakterijske konzervanse.
Treatment with Savene had to be started within 6 hours from the incident and was repeated after 24 and 48 hours. 
Liječenje lijekom Savene je moralo započeti unutar 6 sati od nezgode te je bilo ponovljeno nakon 24 i 48 sati.
• Weight loss, loss of appetite 
• Gubitak težine, gubitak apetita
Only one of the 36 patients required surgery. 
Samo je jedan od 36 bolesnika trebao kiruršku intervenciju.
If you get any of the above symptoms, seek medical advice immediately. 
Ako imate bilo koji od gore navedenih simptoma, odmah potražite liječničku pomoć.
What Savene is and what it is used for What you need to know before you use Savene How to use Savene 
Što je Savene i za što se koristi Što morate znati prije nego počnete primjenjivati Savene
• Other live attenuated vaccines: risk of systemic, possible fatal disease. 
• drugim živim oslabljenim cjepivima: rizik od sistemske, moguće smrtonosne bolesti.
The first infusion should be initiated as soon as possible, within the first six hours after the accident. 
Prvu infuziju treba dati što je moguće prije, unutar prvih šest sati od nezgode.
The elimination half-life of the two-ring opened metabolite ADR-925 is not given in literature. 
Poluvrijeme eliminacije otvorenog dvoprstenastog metabolita ADR-925 nije navedeno u literaturi.
Children and adolescents Savene should not be administered to children below the age of 18 years. 
Savene se ne smije davati djeci mlađoj od 18 godina.
Based on a limited number of patients, interindividual variability calculated as the coefficient of variation (CV %) was estimated to be approximately 30 % for the main pharmacokinetic parameters. 
Temeljeno na ograničenom broju bolesnika, interindividualna varijabilnost izračunata kao koeficijent varijacije (CV %) procijenjena je na otprilike 30% glavnih farmakokinetičkih parametara.
Volume of distribution is independent of dose. 
Volumen distribucije neovisan je o dozi.
- In order to avoid the potential contamination of the medicine by microbes, the product should be used immediately. 
- Kako bi se izbjegla potencijalna kontaminacija lijeka mikrobima, lijek treba odmah upotrijebiti.
This is equivalent to 81% of the recommended maximum daily dietary intake of sodium for an adult. 
To odgovara 81 % preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
Inter- and intra-individual pharmacokinetic variabilities have not been studied systematically. 
Inter- i intraindividualne farmakokinetičke varijabilnosti nisu sustavno ispitivane.
Use of gloves and other protective clothing to prevent skin contact is recommended. 
Preporučuje se upotreba rukavica i ostale zaštitne odjeće za sprječavanje kontakta s kožom.
The apparent effects were greater during chronic than acute administration. 
Vidljivi učinci bili su veći pri kroničnoj nego akutnoj primjeni.
Overall, the most commonly received anthracycline was epirubicin (56 % of the patients). 
Općenito uzevši, najčešći antraciklin koji su primili bio je epirubicin (56% bolesnika).
It is important that you read the entire content of this procedure prior to the preparation of Savene. 
Važno je pročitati sav sadržaj ovog postupka prije pripremanja lijeka Savene.
- Myelosuppressive medicines (decrease production of red, white, or coagulating blood cells). 
- Mijelosupresivne lijekove (smanjuju proizvodnju crvenih, bijelih ili koagulacijskih krvnih stanica).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
• Blood clot in the vein, usually in an arm or leg 
• Krvni ugrušak u veni, obično u ruci ili nozi
There is insufficient data available to draw any definite conclusions regarding intrinsic pharmacokinetic factors such as age, gender, race and weight. 
Nema dovoljno dostupnih podataka temeljem kojih bi se utvrdili unutarnji farmakokinetički faktori kao što su starosna dob, spol, rasa i težina.
Savene is supplied as: 
Savene se isporučuje kao:
Eighteen were evaluable for efficacy and safety and a further five patients were evaluable for toxicity only. 
U osamnaest bolesnika su se mogle procijeniti djelotvornost i sigurnost, a u preostalih pet mogla se je procijeniti samo toksičnost.
If you are at risk of high potassium levels in your blood, your doctor will monitor this. 
Ako kod Vas postoji rizik od visoke razine kalija u krvi, Vaš liječnik će to nadzirati.
• Reduction in any of your senses (sight, smell, hearing, touch, taste) 
• Slabljenje bilo kojeg osjeta (vid, njuh, sluh, dodir, okus)
A number of published reports comprising more than 1000 patients have demonstrated a uniform pattern of dose dependent adverse reactions. 
Brojna objavljena izvješća koja obuhvaćaju više od 1000 bolesnika pokazala su uniforman uzorak ovisnosti nuspojava o dozi.
< PC: {number} [product code] 
PC: {broj} [oznaka lijeka]
Inhibition of topoisomerase II. 
Inhibicija topoizomeraze II.
Dexrazoxane has two major mechanisms of action: 
Deksrazoksan ima dva glavna mehanizma djelovanja:
There is limited information about the effect of Savene on fertility - if you have a concern about this speak to you doctor. 
Postoje ograničene informacije o učinku lijeka Savene na plodnost: u slučaju zabrinutosti obratite se liječniku.
Savene infusion will be given at the same time every day of your treatment. 
Infuzija lijeka Savene bit će dana u isto vrijeme svaki dan Vašeg liječenja.
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) 
Vrlo često (≥1/10) Često (≥1/100 i <1/10) Manje često (≥1/1000 i <1/100) Rijetko (≥1/10 000 i <1/1000)
• Inflammation of a blood vessel just under the skin, often with a small blood clot 
• Upala krvne žile odmah ispod kože, često uz mali krvni ugrušak
36 patients were evaluable for efficacy. 
U 36 bolesnika se je mogla procijeniti djelotvornost.
For patients with a body surface area of more than 2 m2 the single dose should not exceed 2000 mg. 
U bolesnika površine tijela veće od 2 m2 jedna doza ne smije prekoračiti 2000 mg.
In both studies all patients had received anthracycline. 
U oba ispitivanja svi su bolesnici primili antraciklin.
The safety and efficacy of Savene in children below the age of 18 years have not been established and no data are available. 
Pedijatrijska populacija Sigurnost i djelotvornost lijeka Savene u djece mlađe od 18 godina nisu ustanovljeni i nema dostupnih podataka.
Due to the rarity of the condition only historical data could be used for comparison (demonstrating surgical rates of 35-50 %, in one country 100% in biopsy proven cases). 
Zbog male učestalosti navedenog stanja, za usporedbu su se mogli koristiti samo povijesni podaci (pokazujući stopu kirurških zahvata od 35-50%, u jednoj zemlji 100% slučajeva potvrđenih biopsijom).
Most anti-cancer medicines are administered intravenously (into a vein). 
Većina lijekova protiv raka daje se intravenski (u venu).
All items for preparation, administration or cleaning, including gloves, as well as liquid waste should be disposed of in accordance with local requirements. 
Sav pribor za pripremu, primjenu ili čišćenje, uključujući rukavice, kao i tekući otpad treba zbrinuti sukladno nacionalnim propisima.
Cooling procedures such as ice packs should have been removed from the area at least 15 minutes before the Savene administration in order to allow sufficient blood flow. 
Postupci hlađenja, kao što su ledeni oblozi, moraju biti uklonjeni s tog područja barem 15 minuta prije primjene lijeka Savene kako biste omogućili dostatan protok krvi.
Savene should not be administered if you are pregnant. 
Savene se ne smije primijeniti ako ste trudni.
The apparent volumes of distribution are 0.13-1.3 l/kg (median 0.49 l/kg). 
Prividni volumeni distribucije su 0,13-1,3 l/kg (medijan 0,49 l/kg).
4.1 Before reconstitution and dilution: - Store below 25 °C. 
4.1 Prije rekonstitucije i razrjeđivanja: - Čuvati na temperaturi ispod 25 °C.