natgillin/translations-raw huggingface dataset:
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
What Zinbryta looks like and contents of the pack Zinbryta is a colourless to slightly yellow, clear to opalescent liquid contained within a syringe/pen.
Zinbryta je bezbojna do blago žuta, bistra do opalescentna tekućina koja se nalazi u štrcaljki/brizgalici.
How long to use Zinbryta
Kako dugo primjenjivati Zinbrytu
Do not share Zinbryta pre-filled syringe.
Nemojte dijeliti Zinbryta napunjenu štrcaljku.
• Rare (≥1/10, 000 to <1/1,000)
• rijetko (≥1/10 000 i <1/1000)
Serious reactions, including autoimmune hepatitis, hepatitis and jaundice, were observed in 1.7% of patients in clinical trials.
uključujući autoimuni hepatitis, hepatitis i žuticu, opažene su u kliničkim ispitivanjima u
If your MS does not respond to Zinbryta, your doctor may decide to stop your treatment with Zinbryta.
Ako u Vas multipla skleroza ne odgovara na lijek Zinbryta, liječnik može odlučiti zaustaviti liječenje Zinbrytom.
This may cause the pen to accidentally lock.
To bi moglo prouzročiti nehotično blokiranje brizgalice.
- 3 month multipack containing three 150 mg pre-filled syringes (3 boxes containing 1 syringe each).
- Višestruko pakiranje za 3 mjeseca sadrži tri napunjene štrcaljke od 150 mg (3 kutije od kojih svaka sadrži 1 štrcaljku).
Treatment initiation is not recommended in patients with history of concurrent autoimmune conditions other than multiple sclerosis.
Ne preporučuje se započeti liječenje u bolesnika s istodobnim autoimunim bolestima u anamnezi osim multiple skleroze.
How to inject Zinbryta
Kako injicirati Zinbrytu
• Hepatic Risk Management Guide for Physicians;
• Vodič za liječnike o zbrinjavanju rizika za jetru
• unexplained nausea (feeling sick)
• neobjašnjiva mučnina • povraćanje
How Zinbryta works
Kako djeluje Zinbryta
Store in a refrigerator (2oC-8oC).
6.4 Posebne mjere pri čuvanju lijeka Čuvati u hladnjaku (2oC-8oC).
An increased incidence of serious colitis (<1%) was reported in patients treated with Zinbryta in clinical studies.
U kliničkim ispitivanjima zabilježena je povećana incidencija ozbiljnog kolitisa (<1%) u bolesnika liječenih Zinbrytom.
Depression: (Uncommon - may affect up to 1 in 100 people)
Depresija: (Manje često - mogu se javiti u manje od 1 na 100 osoba)
Mean number of new or newly enlarging T2 hyperintense lesions
Srednji broj novih ili novoprogredirajućih hiperintenzivnih lezija na T2-mjerenoj snimci
Can be stored at room temperature (up to 30°C) for a single period up of to 30 days.
Može se čuvati na sobnoj temperaturi (do 30 oC) u jednokratnom razdoblju do 30 dana.
Using one hand, hold the syringe by the glass barrel.
4. korak: Snažnim pokretom uklonite pokrov igle Jednom rukom držite štrcaljku za stakleni cilindar.
Gauze Pad
Česte nuspojave
Inflammation of the bowel (colitis): (Uncommon - may affect up to 1 in 100 people)
Upala crijeva (kolitis): (Manje često - mogu se javiti u manje od 1 na 100 osoba)
• Keep Zinbryta pre-filled syringe and all medicines out of reach and sight of children.
• Zinbryta napunjenu štrcaljku i sve lijekove čuvajte izvan pogleda i dohvata djece.
A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe.
Na štrcaljku je pričvršćena igla od 29 G i 0,5 inča.
You will also have a blood test to check your liver every month, as close as possible before each dose of Zinbryta, and more often if your doctor decides this is necessary.
Također ćete svaki mjesec provoditi krvni test za provjeru jetre, što bliže prije primjene svake doze
Caution - do not recap the Zinbryta prefilled syringe.
Oprez - nemojte vraćati zatvarač natrag na Zinbryta napunjenu štrcaljku.
Skin reactions generally resolved with standard care, including treatment with topical or systemic steroids.
uključujući liječenje topikalnim ili sistemskim steroidima.
Talk to your doctor before using Zinbryta: - if you have any other autoimmune disorders in addition to MS - if you are taking, have recently taken or might take any other medicines and herbal supplements.
Obratite se svom liječniku prije nego primijenite Zinbrytu: - ako imate neke druge autoimune poremećaje osim multiple skleroze
Daclizumab is not expected to undergo metabolism by hepatic enzymes such as CYP isoenzymes (see section 4.5).
Ne očekuje se da se daklizumab metabolizira jetrenim enzimima kao što su CYP izoenzimi (vidjeti dio
Respiratory tract infection
Infekcija dišnih putova
In patients with severe active infection, a delay in initiation of Zinbryta therapy should be considered (see section 4.8).
U bolesnika s teškom aktivnom infekcijom, treba uzeti u obzir odgodu početka liječenja Zinbrytom
• skin rashes, including inflamed, irritated, itchy, dry or peeling skin (dermatitis, eczema,
• kožni osip, uključujući i upaljenu, nadraženu kožu, svrbež, suhu kožu ili ljuštenje kože
Patients with RMS, at least 1 relapse (clinical and/or MRI) during the year prior to randomisation, and had an EDSS score between 0 to 5.0.
Bolesnici s RMS-om, najmanje 1 relapsom (klinički i/ili MR)
Do not reuse the Zinbryta pre-filled syringe.
Nemojte ponovno upotrijebiti Zinbryta napunjenu štrcaljku.
Treatment should be initiated by a physician experienced in the management of multiple sclerosis.
4.2 Doziranje i način primjene Liječenje treba započeti pod nadzorom liječnika koji ima iskustva u liječenju multiple skleroze.
Skin reactions, some serious (e.g. exfoliative rash or dermatitis, toxic skin eruption), have been reported with Zinbryta.
Pri liječenju Zinbrytom zabilježene su kožne reakcije, od kojih i neke ozbiljne (npr. eksfolijativni osip ili dermatitis, toksična kožna erupcija).
† MRI analyses used evaluable dataset for each MRI endpoint.
† Analiza MR koristila je skup podataka koji su se mogli ocijeniti za svaki MR ishod.
Alcohol Wipe
Vata natopljena alkoholom
Only one dose should be administered at a time to make up for a missed dose.
Kako bi se nadoknadila propuštena doza, odjednom se smije primijeniti samo jedna doza.
• Be designed to enable physicians to present patient-friendly information;
Kartica za bolesnika treba: • biti osmišljena tako da omogući liječnicima pružanje informacija bolesnicima na njima blizak način
Slowly push the plunger all the way down until the syringe is empty.
Polako pritiskajte klip do kraja prema dolje sve dok štrcaljka ne bude prazna (vidjeti sliku J).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-Filled Pen Label
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica napunjene brizgalice
If a patient develops a diffuse or highly inflammatory rash, referral to a dermatologist and discontinuation of Zinbryta may be required (see section 4.8).
Ako bolesnik razvije difuzni ili visoko upalni osip, može biti potrebno upućivanje dermatologu i trajni prekid liječenja Zinbrytom (vidjeti dio
Skin exfoliation
Eksfolijacija kože
• severe wide-spread rash.
• teški rasprostranjeni osip
No studies were conducted to evaluate daclizumab pharmacokinetics in patients with renal or hepatic impairment.
Oštećenja bubrega ili jetre Nisu provedena ispitivanja za procjenu farmakokinetike daklizumaba u bolesnika s oštećenjem bubrega ili jetre.
Skin reactions: (Common - may affect up to 1 in 10 people)
Kožne reakcije: (Često - mogu se javiti u manje od 1 na 10 osoba)
Step 5: Gently pinch your injection site Gently pinch the skin around the cleaned injection site using thumb and forefinger to create a slight bulge.
Nježno uštipnite kožu oko očišćenog mjesta za injekciju koristeći palac i kažiprst da napravite malu izbočinu. (vidjeti sliku H).
Refer to section below, ‘Educational Guidance', for details of the Hepatic Risk Management Guide for Physicians and Patient Card that are recommended for use with this medicine.
Detalji koji se odnose na Vodič za liječnike o zbrinjavanju rizika za jetru i Karticu za bolesnika, koje se preporučuje poznavati uz uporabu ovog lijeka, nalaze se u nastavku u dijelu „Smjernice za edukaciju“.
Patient serum transaminase and total bilirubin levels should be monitored at least monthly and as close as possible before each administration, and more frequently as clinically indicated during treatment and up to 6 months after the last dose of Zinbryta.
Tijekom liječenja i do 6 mjeseci nakon zadnje doze Zinbryte, u bolesnika treba pratiti razine serumskih transaminaza i ukupnog bilirubina najmanje jednom mjesečno, i to što bliže prije svake primjene lijeka, a češće ako je klinički indicirano.
• Common (≥1/100 to <1/10)
• često (≥1/100 i <1/10)
The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Order Class by frequency and incidence.
Nuspojave su prikazane kao MedDRA-ini preporučeni pojmovi prema MedDRA klasifikaciji organskih sustava po učestalosti i incidenciji.
• Check with your doctor, pharmacist or nurse about the right way to throw away the used syringe.
• Pitajte svog liječnika, ljekarnika ili medicinsku sestru za ispravan način bacanja iskorištenih štrcaljki.
Serious hepatic injury including elevations of serum transaminases and fatal cases of autoimmune hepatitis and fulminant liver failure have occurred in patients treated with Zinbryta (see section 4.8).
U bolesnika liječenih Zinbrytom zabilježeno je ozbiljno oštećenje jetre, uključujući povišenja serumskih transaminaza te slučajeve autoimunog hepatitisa i fulminantnog zatajenja jetre sa smrtnim ishodom (vidjeti dio 4.8).
The safety and effectiveness of Zinbryta in this age group are not known.
Zinbryte u toj dobnoj skupini nije poznata.
• fever
• flaster
Among the evaluable patients, the majority of treatment-emergent neutralising antibody responses were transient (6% [56 of 913]) and 2% of patients (15 of 913) had persistent responses.
[56 od 913]) a 2% bolesnika (15 od 913) imalo je trajni odgovor.
• Keep this leaflet and the Patient Card. You may need to read them again.
• Sačuvajte ovu uputu i karticu za bolesnika.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-Filled Syringe Label
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica napunjene štrcaljke
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1107/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1107/001
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zinbryta 150 mg injection daclizumab
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Zinbryta 150 mg injekcija daklizumab s.c.
Giving your injection Step 5: Remove the Zinbryta Pen cap a.
5. korak: Odstranite zatvarač sa Zinbryta brizgalice a.
Percent ≥ 2 relapses in the year prior to study
Postotak s ≥ 1 Gd imbibiranih lezija (srednja vrijednost) Postotak ≥ 2 relapsa u godini prije ispitivanja
During Zinbryta treatment, mean cell counts for the major immune subsets (T, B, and NK cells) remained within normal ranges; total lymphocyte, T
Zinbrytom, srednji broj stanica za glavne imunološke podskupine (T, B, i NK stanice) ostao je unutar normalnih raspona; ukupni broj limfocita,T i B stanica smanjio su se u prosjeku ≤10% od početne vrijednosti tijekom prve godine liječenja.
Discontinuation due to lymphadenopathy was <1% in Zinbryta-treated patients.
Prekid liječenja zbog limfadenopatije u bolesnika liječenih Zinbrytom bio je <1%.