natgillin/translations-raw huggingface dataset:
As data on use of Zinbryta during pregnancy are limited, the risk to the baby and benefit to the mother should be taken into consideration. 
Trudnoća i dojenje Budući da su podaci o primjeni Zinbryte tijekom trudnoće ograničeni, treba uzeti u obzir rizik za dijete i korist za majku.
• sore throat, tonsillitis (pharyngitis, laryngitis) 
• grlobolja, upala krajnika (faringitis, laringitis)
You will be given a Patient Card with further information about the things to watch out for while taking Zinbryta. 
Dobit ćete Karticu za bolesnika s više informacija o stvarima na koje trebate paziti dok primjenjujete
When observed during Zinbryta clinical studies, lymphopenia was mostly mild to moderate (≥ 500/mm3). 
Limfopenija opažena tijekom kliničkih ispitivanja Zinbryte bila je uglavnom blaga do umjerena (≥ 500/mm3).
Choose an injection site in your thigh, abdomen, or the back of your upper arm (See highlighted areas in Figure D). 
Odaberite mjesto za injiciranje na bedru, trbuhu ili stražnjoj strani nadlaktice (vidjeti označena područja na slici D).
Zinbryta is provided with the needle pre-attached. 
Zinbryta se isporučuje s već pričvršćenom iglom.
The recommended dose of Zinbryta is 150 mg injected subcutaneously once a month. 
Preporučena doza Zinbryte je 150 mg koja se daje supkutanom injekcijom jedanput na mjesec.
Mean number of new T1 Gdenhancing lesions between 8 and 24 weeks (on monthly MRI scans) 
Srednji broj novih lezija imbibiranih gadolinijem na T1-mjerenoj snimci između 8 i 24 tjedana (na mjesečnom
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK INNER CARTON (without blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KARTONSKA KUTIJA VIŠESTRUKOG PAKIRANJA (bez plavog okvira)
• alcohol wipe 
• vata natopljena alkoholom
If a patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g. unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine), it is recommended to promptly measure serum transaminases, discontinue treatment with Zinbryta, as appropriate, and promptly refer the patient to a hepatologist. 
Ako bolesnik razvije kliničke znakove ili simptome koji upućuju na disfunkciju jetre (npr. neobjašnjiva mučnina, povraćanje, bol u abdomenu, umor, anoreksija, ili žutica i/ili tamni urin), preporučuje se odmah izmjeriti serumske transaminaze, prekinuti liječenje Zinbrytom i bolesnika bez odlaganja uputiti hepatologu.
Percentage of relapse-free patients 
Postotak bolesnika bez relapsa
Zinbryta is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylaxis or anaphylactoid reactions) to daclizumab or to any of the excipients (see section 6.1). 
Zinbryta je kontraindicirana u bolesnika s anamnezom teške preosjetljivosti (npr. anafilaksija ili anafilaktoidna rekcija) na daklizumab ili na neku od pomoćnih tvari (vidjeti dio 6.1).
Let the injection site dry on its own before injecting the dose. 
Pustite da se mjesto injiciranja samo osuši prije injiciranja doze.
Zinbryta is for subcutaneous use. 
Zinbryta je namijenjena za supkutanu primjenu.
• the solution is any other colour than colourless to slightly yellow. 
• otopina bilo koje druge boje osim bezbojne do blago žute.
If a dose is missed and it is more than 2 weeks from the missed dose, patients should skip the missed dose, wait until their next scheduled dose, and then remain on their original monthly dosing schedule. 
Ako je doza propuštena i prošlo je više od 2 tjedna od propuštene doze, bolesnici trebaju preskočiti propuštenu dozu, pričekati njihovu sljedeću dozu, a zatim nastaviti s izvornim mjesečnim rasporedom doziranja.
Before you prepare your injection, take the syringe out of the fridge and let it warm to room temperature. 
Priprema za injiciranje Napomena: Prije pripreme injekcije, izvadite štrcaljku iz hladnjaka i pustite da se ugrije na sobnu temperaturu.
There is limited data on concomitant use of Zinbryta with MS symptomatic therapies. 
Ograničeni su podaci o primjeni Zinbryte istodobno sa simptomatskim terapijama multiple skleroze.
It is not known whether Zinbryta passes into breast milk. 
Nije poznato da li se Zinbryta izlučuje u majčino mlijeko.
Zinbryta pre-filled syringe is for subcutaneous injection (injection into skin). 
Zinbryta napunjena štrcaljka namijenjena je za supkutanu injekciju (injekciju pod kožu).
Upper respiratory tract infection† 
Infekcija gornjih dišnih putova†
In patients with neutralising antibodies, daclizumab clearance was increased on average by 19% (see section 5.2). 
U bolesnika s neutralizirajućim protutijelima, klirens daklizumaba bio je povišen u prosjeku za 19% (vidjeti dio 5.2).
Step 9: Disposing of used Zinbryta Pens 
9. korak: Odlaganje iskorištenih Zinbryta brizgalica
The incidence of discontinuation due to medicine related hepatic disorders was 5% in Zinbryta-treated patients and 4% in interferon beta-1a (intramuscular). 
Incidencija prekida liječenja zbog jetrenih poremećaja povezanih s lijekom iznosila je 5% u bolesnika liječenih Zinbrytom i 4% u bolesnika liječenih interferonom beta-1a (intramuskularno).
The active substance in Zinbryta is daclizumab. 
Djelatna tvar Zinbryte je daklizumab.
Step 1: Collect your supplies and wash your hands Use a well-lit, clean, flat surface to work on, like a table. 
Koristite dobro osvijetljenu, čistu i ravnu površinu za rad, poput stola.
Total lymphocyte counts <0.8x109 cells/L ([Common Terminology Criteria for Adverse 
Ukupni broj limfocita <0,8x109 stanica/L
If you do develop liver problems your MS doctor may stop your treatment with Zinbryta and refer you to a liver specialist (see section 4, Possible side effects). 
Vas liječi protiv multiple skleroze može Vam prekinuti liječenje Zinbrytom i uputiti Vas specijalistu za jetru (vidjeti dio 4. Moguće nuspojave)
If you do not not undergo your scheduled blood tests your doctor may decide to stop treatment with Zinbryta. 
Ako se ne pridržavate rasporeda krvnih pretraga, liječnik Vam može odlučiti prekinuti liječenje Zinbrytom.
Table 4: SELECT study clinical and MRI results (at 52 weeks) Placebo 
Tablica 4: Klinički i MR rezultati ispitivanja SELECT (u 52. tjednu)
It is not known whether Zinbryta is secreted in human milk. 
Nije poznato izlučuje li se Zinbryta u ljudsko mlijeko.
Pre-filled syringe made of glass (Type 1) with a rubber stopper and thermoplastic rigid needle shield containing 1 mL of solution. 
Napunjena štrcaljka napravljena od stakla (tip 1) s gumenim čepom i termoplastičnim krutim štitnikom igle koja sadrži 1 ml otopine.
• The importance of monitoring the liver function (AST, ALT and total bilirubin levels) at least monthly (or more frequently as clinically indicated) as close as possible before each treatment administration, and for up to six months after the last dose; 
• važnost praćenja funkcije jetre (razine AST-a, ALT-a i ukupnog bilirubina) najmanje jednom mjesečno (ili češće ako je klinički indicirano) što bliže prije svake primjene lijeka, te do šest mjeseci nakon zadnje doze
• If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C for up to 30 days. 
• Ako bude potrebno, Zinbryta se može čuvati u zatvorenoj originalnoj kutiji bez rashlađivanja na temperaturi do 30°C do 30 dana.
The colitis improved with discontinuation of Zinbryta and standard treatment. 
Kolitis se poboljšao nakon prekida liječenja Zinbrytom i primjene standardnog liječenja.
Baseline characteristics Mean age (years) Mean disease duration (years) Mean number of relapses within 12 months prior to study Median EDSS score Percent with EDSS ≥ 3.5 
Srednja vrijednost broja relapsa unutar 12 mjeseci prije ispitivanja Medijan EDSS ocjene Postotak s EDSS ≥ 3,5
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OUTER CARTON (with blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KARTONSKA KUTIJA VIŠESTRUKOG PAKIRANJA (s plavim okvirom)
Do not use external heat sources such as hot water to warm Zinbryta pre-filled syringe. 
Nemojte koristiti vanjske izvore topline kao što je vruća voda da zagrijete Zinbryta napunjenu štrcaljku.
Table 1: Adverse reactions reported for Zinbryta 150mg System Organ Class 
Tablica 1: Nuspojave prijavljene za Zinbrytu od 150 mg Klasifikacija organskih sustava
In case a dose is missed and it is within 2 weeks of the missed dose, patients should be instructed to inject without delay their missed dose and then remain on their original monthly dosing schedule. 
Ako je doza propuštena i nisu još prošla 2 tjedna od propuštene doze, bolesnike treba uputiti da bez odgađanja injiciraju propuštenu dozu čim se sjete, a zatim nastave s izvornim mjesečnim rasporedom doziranja.
• your skin or the whites of the eyes turn yellow Increased tiredness, dark urine and skin or whites of the eyes turning yellow also may be symptoms of liver problems, see section above on liver problems. 
Povećan umor, tamna mokraća i žuta boja kože ili bjeloočnica mogu također biti simptomi problema s jetrom, vidjeti prethodni dio o problemima s jetrom.
• inflamed or enlarged lymph nodes (lymphadenopathy, lymphadenitis) 
• upaljeni ili povećani limfni čvorovi (limfadenopatija, limfadenitis)
• Very common (≥ 1/10) 
• vrlo često (≥ 1/10)
Elimination As an IgG1 monoclonal antibody, daclizumab is not expected to undergo renal elimination. 
Eliminacija Budući da je IgG1 monoklonsko protutijelo, za daklizumab se ne očekuje eliminacija putem bubrega.
Marketing Authorisation Holder Biogen Idec Ltd. 
Nositelj odobrenja za stavljanje lijeka u promet Biogen Idec Ltd.
• The importance of the liver function monitoring, at least monthly during treatment (or more frequently as clinically indicated), and for up to 6 months after the last dose; 
• navesti važnost praćenja funkcije jetre najmanje jednom mjesečno tijekom liječenja (ili češće ako je klinički indicirano) te do 6 mjeseci nakon zadnje doze
• increased tiredness 
• povećan umor
1.0 point improvement p=0.0008 
pogoršanje od 3,0 boda poboljšanje od 1,0 bod p=0,0008
If you remove the cap, do not re-cap the pen. 
Ako zatvarač ipak skinete, nemojte ga vraćati na brizgalicu.
The Card informs patients of the risk of serious hepatic injury, and its possible symptoms, so that they are aware of situations in which they should contact a healthcare professional in a timely manner. 
Kartica obavještava bolesnika o riziku od ozbiljnog oštećenja jetre i mogućim simptomima, kako bi znao u kojoj se situaciji treba pravodobno obratiti zdravstvenom radniku.
Total exposure (subject-years) ≥ 3 x ULN > 5 x ULN > 10 x ULN > 20 x ULN 
> 5 x GGN > 10 x GGN > 20 x GGN
Parts of the Zinbryta pre-filled syringe (See Figure C) 
Dijelovi Zinbryta napunjene štrcaljke (vidjeti sliku C)
Pre-existing hepatic disease or hepatic impairment (see section 4.4). 
Postojeća bolest jetre ili oštećenje jetre (vidjeti dio 4.4).
Percentage of patients with clinically meaningful worsening in MSIS-29 
Postotak bolesnika s klinički značajnim pogoršanjem u fizičkoj ocjeni MSIS-29 (≥7,5 bodova)
In the active-controlled study (the DECIDE study), 919 patients received Zinbryta (150 mg, every 4 weeks) and 922 patients received interferon beta-1a intramuscular, (30 microgram weekly) for a minimum of 2 years and up to 3 years. 
U aktivno kontroliranom ispitivanju (ispitivanje DECIDE), 919 bolesnika je primalo Zinbrytu (150 mg, svaka 4 tjedna) i 922 bolesnika je primalo interferon beta-1a intramuskularno (30 mikrograma tjedno) najmanje 2 godine, a najviše 3 godine.
• The need to provide the patient with the Patient Card and the Acknowledgment Form, discuss their content before starting Zinbryta treatment, informing patients of the risk of hepatic injury, the need for periodic monitoring and the signs or symptoms suggestive of hepatic dysfunction. 
• potrebu da bolesnik prije nego što započne liječenje Zinbrytom dobije Karticu za bolesnika i Obrazac potvrde o upoznatosti s rizicima, da bolesnicima objasne sadržaj tih dokumenata koji bolesnike upoznaju s rizikom od oštećenja jetre, potrebom za periodičnim praćenjem i znakovima ili simptomima koji ukazuju na disfunkciju jetre.
Caution is recommended when administering medicinal products of known hepatotoxic potential including non-prescription products and herbal supplements concomitantly with Zinbryta (see section 4.4). 
Preporučuje se oprez kada se lijekovi poznatog hepatotoksičnog potencijala, uključujući bezreceptne lijekove i biljne pripravke, primjenjuju istodobno s lijekom Zinbryta (vidjeti dio 4.4).
The SELECT study was double-blind, randomised, placebo-controlled, with either Zinbryta 150 mg (n=208), or 300 mg (n=209) versus placebo (n=204) every 4 weeks for 52 weeks. 
SELECT je bilo dvostruko slijepo, randomizirano, placebom kontrolirano ispitivanje sa Zinbrytom od 150 mg (n = 208) ili 300 mg (n = 209) u odnosu na placebo (n = 204) primijenjene svaka 4 tjedna tijekom 52 tjedana.
LIST OF EXCIPIENTS Sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections 
Natrijev sukcinat, sukcinatna kiselina, natrijev klorid, polisorbat 80, voda za injekcije
In clinical studies, Zinbryta increased the incidence of depression [5% vs 1% (placebo); 8% vs 6% (interferon beta-1a (intramuscular))]; the incidence of serious reactions of depression was <1% with Zinbryta. 
U kliničkim ispitivanjima Zinbryta je povećala incidenciju depresije [5% naspram 1% (placebo); 8% naspram 6% (interferon beta-1a (intramuskularno)]; incidencija ozbiljnih nuspojava depresije bila je <1% sa Zinbrytom.
If a patient develops signs or symptoms of autoimmune haemolytic anaemia (e.g. pallor, fatigue, dark urine, jaundice, shortness of breath), consider referring to a specialist and discontinuing Zinbryta (see section 4.8). 
Ako bolesnik razvije znakove ili simptome autoimune hemolitične anemije (npr. bljedilo, umor, tamni urin, žuticu, nedostatak zraka), razmislite o tome da bolesnika uputite specijalistu i prekinete liječenje Zinbrytom (vidjeti dio 4.8).
Zinbryta can be stored at room temperature (up to 30oC) in the original pack for 30 days. 
Zinbryta se može čuvati na sobnoj temperaturi (do 30 °C) u originalnom pakiranju 30 dana.
Treatment with Zinbryta 150 mg every 4 weeks versus placebo significantly reduced the annualised relapse rate (ARR) and risk of relapse compared to placebo. 
Rezultati ispitivanja SELECT prikazani su u tablici 4. Liječenje Zinbrytom od 150 mg svaka 4 tjedna u odnosu na placebo značajno je smanjilo godišnju stopu relapsa i rizik od relapsa u usporedbi s placebom.
Zinbryta significantly reduced the ARR and the risk of relapse, compared to interferon beta-1a (intramuscular)-treated patients. 
Zinbryta je značajno smanjila godišnju stopu relapsa i rizik od relapsa, u odnosu na bolesnike liječene interferonom beta-1a (intramuskularno).
Compared with interferon beta-1a intramuscular (n=440), Zinbryta (n=404) led to reductions on ARR (rate ratio 0.52 [95% CI: 0.42, 0.64], p<0.0001), number of new or newly enlarging T2 hyperintense lesions (lesion mean ratio 0.46 [95% CI: 0.37, 0.57], p<0.0001), and 24 weeks confirmed disability progression (hazard ratio 0.60 [95% CI: 0.40, 0.89], p=0.012). 
U usporedbi s intramuskularnim interferonom beta-1a (n = 440), Zinbryta (n = 404) je dovela do smanjenja godišnje stope relapsa (omjer stopa 0,52 [95% CI: 0,42, 0,64], p <0,0001), broja novih ili novoprogredirajućih hiperintenzivnih lezija na T2-mjerenoj snimci (srednji omjer lezija 0,46
In clinical trials, an increased incidence of elevations of ALT or AST was reported more frequently in Zinbryta-treated patients compared to placebo or interferon beta1a (intramuscular). 
Povećana incidencija povišenja razine vrijednosti ALT ili AST prijavljena je češće u bolesnika liječenih Zinbrytom u usporedbi s placebom ili interferonom beta-1a (intramuskularno).
Do not pull back on the plunger. 
Nemojte vraćati zatvarač na brizgalicu.
Step 7: Remove the Zinbryta Pen from your injection site a. 
7. korak: Uklonite Zinbryta brizgalicu s mjesta injekcije a.
The syringe inside the pen is a pre-filled syringe made of glass (Type 1) with a rubber stopper and thermoplastic rigid needle shield, containing 1 mL of solution. 
Štrcaljka unutar brizgalice jest napunjena štrcaljka napravljena od stakla (tip 1) s gumenim čepom i termoplastičnim krutim štitnikom igle koja sadrži 1 ml otopine.
Events - CTCAE] Grade 2; at least one measurement) occurred in 4% of placebo-treated and 5% of Zinbryta-treated patients in the SELECT study, and 9% of the interferon beta-1a (intramuscular)-treated and 8% of Zinbryta-treated patients in the DECIDE study. 
CTCAE)] 2. stupnja; pri najmanje jednom mjerenju) zabilježen je u 4% bolesnika kojima je davan placebo i 5% bolesnika liječenih Zinbrytom u ispitivanju SELECT te u 9% bolesnika liječenih interferonom beta-1a (intramuskularno) i 8% bolesnika liječenih Zinbrytom u ispitivanju DECIDE.
Instructions for injecting Zinbryta 
Upute za injiciranje Zinbryte
In addition, Zinbryta reduced clinically meaningful worsening in the patient reported physical impact of MS (≥7.5 point worsening from baseline to week 96 in the MSIS-29 
Osim toga, Zinbryta je smanjila klinički značajno pogoršanje fizičkog učinka MS-a kojeg su izvijestili bolesnici (pogoršanje od ≥7,5 bodova od početne vrijednosti do 96. tjedna prema fizičkoj ocjeni ljestvice MSIS-29) u usporedbi s interferonom beta-1a (intramuskularno).
Lung infections: 
Infekcije pluća:
The physician should discuss the risk of hepatic injury with patients and provide them with a Patient Card. 
Liječnici moraju upoznati bolesnike s rizikom od oštećenja jetre i dati im Karticu za bolesnika.
No impact on male or female fertility as assessed by fertility indices was detected in animal studies (see section 5.3). 
Plodnost Prema ocjeni indeksa plodnosti u ispitivanjima na životinjama nije pronađen učinak na mušku ili žensku plodnost (vidjeti dio 5.3).
The DECIDE study was double-blind, randomised, parallel-group, active-controlled with Zinbryta 150 mg every 4 weeks (n=919) versus interferon beta-1a (intramuscular) 30 micrograms weekly (n=922), for a minimum of 2 to a maximum of 3 years (96 to 144 weeks). 
DECIDE je bilo dvostruko slijepo, randomizirano, aktivnim lijekom kontrolirano ispitivanje usporednih skupina sa Zinbrytom od 150 mg svaka 4 tjedna (n = 919) u odnosu na interferon beta-1a (intramuskularno) 30 mikrograma tjedno (n = 922), u trajanju od najmanje 2 do maksimalno 3 godine (96 do 144 tjedna).
Your doctor will evaluate if any medicines or supplements you are taking have liver side effects and whether you should continue these medicines while receiving Zinbryta. 
Liječnik će procijeniti ima li bilo koji od lijekova ili dodataka prehrani koje uzimate jetrene nuspojave i smijete li nastaviti uzimati te lijekove dok se liječite Zinbrytom.
Rash*† 
Osip*†
Step 2: Check The Zinbryta Pre-filled Syringe 
2. korak: Provjerite Zinbryta napunjenu štrcaljku
In the placebo-controlled study (the SELECT study), 417 patients received Zinbryta (150 mg, n=208; 300 mg, n=209; every 4 weeks) for up to 1 year. 
U placebom kontroliranom ispitivanju (ispitivanje SELECT), 417 bolesnika je primalo Zinbrytu do 1 godine (150 mg, n=208; 300 mg, n=209; svaka 4 tjedna).
Do not remove the cap until you are ready to inject. 
Nemojte skidati zatvarač sve dok niste spremni injicirati.
• Check the expiry date on the Zinbryta prefilled syringe (See Figure D). 
• Provjerite rok valjanosti otisnut na Zinbryta napunjenoj štrcaljki (vidjeti sliku D).
• skin infection (folliculitis, acne) 
• infekcija kože (folikulitis, akne)
- if you have a serious infection, such as pneumonia. 
- ako imate depresiju ili ste je imali u prošlosti - ako imate ozbiljnu infekciju, kao što je upala pluća
Patients on Zinbryta may receive non-live vaccines. 
Bolesnici liječeni Zinbrytom mogu primiti neživa cjepiva.
In addition, there was a statistically significant effect on 24 week confirmed disability progression in Zinbryta treated patients with a hazard ratio 0.24 [95% CI: 0.09, 0.63]. 
Osim toga, u bolesnika liječenih Zinbrytom došlo je do statistički značajnog učinka na potvrđenu progresiju onesposobljenosti tijekom 24 tjedna s omjerom hazarda od 0,24 [95% CI: 0,09, 0,63].
• Zinbryta pre-filled syringe is for injecting the medicine under the skin only (subcutaneous). 
• Zinbryta napunjena štrcaljka je namijenjena samo za ubrizgavanje lijeka potkožno (supkutano).
In clinical studies, Zinbryta increased the incidence of infections [50% vs 44% (placebo) and 65% vs 57% (interferon beta-1a (intramuscular))] and serious infections [3% vs 0% (placebo); 4% vs 2% (interferon beta-1a (intramuscular))] compared to placebo and interferon beta-1a (intramuscular). 
U kliničkim ispitivanjima Zinbryta je povećala incidenciju infekcija [50% naspram 44% (placebo) i 65% naspram 57% (interferon beta-1a (intramuskularno))] i ozbiljnih infekcija [3% naspram 0% (placebo); 4% naspram 2% (interferon beta-1a (intramuskularno))] u usporedbi s placebom i interferonom beta-1a (intramuskularno).
• the solution is cloudy or you can see particles floating in it. 
• otopina zamućena ili možete vidjeti da čestice plutaju u njoj.
The active substance is daclizumab. 
Djelatna tvar je daklizumab.
Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom 
Innovation House 70 Norden Road Maidenhead Berkshire
Multipack: 3 (3 packs of 1) pre-filled pens. 
Višestruko pakiranje: 3 (3 pakiranja od 1) napunjene brizgalice.
Quickly insert the needle straight into the skin fold until the needle is fully under the skin. 
Brzo ubodite iglu ravno u nabor kože tako da je igla potpuno pod kožom (vidjeti sliku I).
• the solution is cloudy or you can see particles floating in it 
• je otopina zamućena ili možete vidjeti da u njoj plutaju čestice
The usual sites for subcutaneous injection include the thigh, abdomen, and back of the upper arm. 
Uobičajena mjesta supkutane injekcije su bedro, trbuh i stražnji dio nadlaktice.
Following subcutaneous administration of daclizumab 150 mg every 4 weeks, steady-state serum daclizumab concentrations were achieved by the 4th dose and daclizumab accumulated to a level approximately 2.5-fold compared to a single dose. 
Nakon supkutane primjene daklizumaba od 150 mg svaka 4 tjedna, koncentracije daklizumaba u serumu u stanju dinamičke ravnoteže postignute su do 4. doze te se daklizumab akumulirao do razine približno 2,5 puta veće u usporedbi s jednom dozom.
Supplies needed for your Zinbryta injection • Zinbryta pre-filled syringe 
Pribor potreban za injiciranje Zinbryte • Zinbryta napunjena štrcaljka
At steady state, daclizumab mean maximum serum concentration (Cmax), minimum serum concentration (Cmin) and area under the serum concentrationtime curve over the dosing interval (AUCtau) values were approximately 30 micrograms/mL, 15 micrograms/mL and 640 day*micrograms/mL, respectively, with inter-patient variability (% CV) of approximately 40%. 
U stanju dinamičke ravnoteže, srednja maksimalna koncentracija daklizumaba u serumu (Cmax) iznosila je približno 30 mikrograma/ml, minimalna koncentracija u serumu (Cmin) iznosila je približno 15 mikrograma/ml, a površina ispod krivulje ovisnosti serumske koncentracije o vremenu tijekom intervala doziranja (AUCtau) približno
Try to do your injection on the same day each month, to help you remember it. For example, inject on the first day of each month. 
Pokušajte obaviti injiciranje istog dana svakog mjeseca, kako biste bolje zapamtili.
- 3 month multipack containing three 150 mg pre-filled pens (3 boxes containing 1 pen each). 
- Višestruko pakiranje za 3 mjeseca sadrži tri napunjene brizgalice od 150 mg (3 kutije od kojih svaka sadrži 1 brizgalicu).
Multipack: 3 (3 packs of 1) pre-filled syringes. 
Višestruko pakiranje: 3 (3 pakiranja od 1) napunjene štrcaljke.
There are limited data from the use of Zinbryta in pregnant women. 
Podaci o primjeni Zinbryte kod trudnica su ograničeni.
Zinbryta pre-filled syringe should be injected into the abdomen, thigh, or the back of the upper arm (see Figure F). 
Zinbryta u napunjenoj štrcaljki injicira se u trbuh, bedra ili stražnji dio nadlaktice (vidjeti sliku F).
What Zinbryta is used for 
Za što se Zinbryta koristi
INFORMATION IN BRAILLE Zinbryta 
16. PODACI NA BRAILLEOVOM PISMU Zinbryta