natgillin/translations-raw huggingface dataset:
Excipients: Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, water for injections. 
Pomoćne tvari: saharoza, L-histidin, L-histidinklorid hidrat, polisorbat 80, voda za injekcije.
How Stelara is given 
Kako se primjenjuje Stelara
STELARA 90 mg solution for injection EU/1/08/494/002 
STELARA 90 mg otopina za injekciju EU/1/08/494/002
STELARA 45 mg solution for injection EU/1/08/494/001 
STELARA 45 mg otopina za injekciju EU/1/08/494/001
How much Stelara is given Your doctor will decide how much Stelara you need to receive and for how long. 
Liječnik će odrediti koju dozu Stelare trebate primiti, te trajanje liječenja.
STELARA 90 mg solution for injection in pre-filled syringe 3 years 
STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki 3 godine
Symptomatic remission is defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. 
Simptomatska remisija definirana je kao Mayo podrezultat za učestalost pražnjenja crijeva 0 ili 1 i podrezultat za rektalno krvarenje 0.
This effect was driven by PsA Study 1. 
Ovaj učinak bio je potaknut PsA Ispitivanjem
Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose or 16 weeks after switching to the 8-weekly maintenance dose. 
U bolesnika kod kojih se 16 tjedana nakon primjene intravenske uvodne doze ili 16 tjedana nakon prelaska na terapiju održavanja primijenjenu svakih 8 tjedana ne pokaže terapijska korist, treba razmotriti prekid liječenja.
PRE-FILLED SYRINGE LABEL TEXT (45 mg) 
TEKST NA NALJEPNICI NAPUNJENE ŠTRCALJKE (45 mg)
Any unused product remaining in the vial and the syringe should be thrown away. 
Sav neiskorišteni lijek koji je preostao u bočici i štrcaljki potrebno je primjereno zbrinuti.
Histologic healing (defined as neutrophil infiltration in < 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue) was assessed at week 8 of UNIFI-I and Week 44 of UNIFI-M. At week 8, after a single intravenous induction dose, significantly greater proportions of patients in the recommended dose group achieved histologic healing (36%) compared with patients in the placebo group (22%). 
Histološko cijeljenje (koje se definiralo kao infiltracija neutrofila u < 5% kripti, izostanak oštećenja kripti te izostanak erozija, ulceracija i granuloma) ocjenjivalo se u 8. tjednu ispitivanja UNIFI-I i 44. tjednu ispitivanja UNIFI-M.
• the number of vials and strength is correct o If your dose is 90 mg you will get one 90 mg vial of Stelara. 
• da je količina bočica i jačina lijeka ispravna o Ako je Vaša doza 90 mg, dobit ćete jednu bočicu Stelare od 90 mg.
In Psoriasis Study 2, the Hospital Anxiety and Depression Scale (HADS) and Work Limitations Questionnaire (WLQ) were also significantly improved in each ustekinumab treatment group compared with placebo. 
Work Limitations Questionnaire, WLQ) također su se značajno poboljšali u svakoj grupi liječenoj ustekinumabom u usporedbi s placebom.
The solution is clear to slightly opalescent, colourless to light yellow. 
Otopina je bistra do blago opalescentna, bezbojna do svijetložuta.
PRE-FILLED SYRINGE LABEL TEXT (90 mg) 
TEKST NA NALJEPNICI NAPUNJENE ŠTRCALJKE (90 mg)
In both studies, patients were randomised to receive a single intravenous administration of either the recommended tiered dose of approximately 6 mg/kg (see Table 1, section 4.2), a fixed dose of 130 mg ustekinumab, or placebo at week 0. 
U oba ispitivanja, bolesnici su bili randomizirani na jednu intravensku primjenu, bilo preporučene doze određene prema tjelesnoj težini (od engl. tiered dose) od otprilike 6 mg/kg (vidjeti Tablicu 1, dio 4.2), bilo fiksne doze od 130 mg ustekinumaba ili placeba u 0. tjednu.
Solution for injection 90 mg/1 mL 1 vial 
Otopina za injekciju 90 mg/1 ml 1 bočica
In Psoriasis Study 1, improvements in nail psoriasis (Nail Psoriasis Severity Index), in the physical and mental component summary scores of the SF-36 and in the Itch Visual Analogue Scale (VAS) were also significant in each ustekinumab treatment group compared with placebo. 
Nail Psoriasis Severity Index), sažetih rezultata fizičkih i mentalnih komponenti SF-36 i vizualno analognoj skali (eng.
Renal and hepatic impairment STELARA has not been studied in these patient populations. 
Ispitivanja sa STELAROM u toj populaciji bolesnika nisu provedena.
Each pre-filled syringe contains 90 mg ustekinumab in 1 mL of solution for injection. 
Jedna napunjena štrcaljka sadrži 90 mg ustekinumaba u 1 ml otopine za injekciju.
The safety and efficacy of ustekinumab was assessed in three randomized, double-blind, placebo-controlled, multicenter studies in adult patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index [CDAI] score of ≥ 220 and ≤ 450). 
Sigurnost i djelotvornost ustekinumaba bila je ocijenjena u tri randomizirana, dvostruko slijepa, placebom kontrolirana, multicentrična ispitivanja u odraslih bolesnika s umjerenim do teškim oblikom aktivne Crohnove bolesti (Indeks aktivnosti Crohnove bolesti od engl.
Patients receiving ustekinumab at the recommended dose showed significant improvements on the histo endoscopic mucosal healing endpoint at week 8 in the ustekinumab group (18%) as compared to theplacebo group (9%). 
U 8. tjednu zabilježeno je značajno poboljšanje histo-endoskopskog cijeljenja sluznice u bolesnika koji su primili ustekinumab u preporučenoj dozi (18%) u usporedbi s onima koji su primili placebo (9%).
Endoscopic normalization was defined as a Mayo endoscopic subscore of 0 and was observed as early as week 8 of UNIFI-I. At week 44 of UNIFI-M, it was achieved in 24% and 29% of patients treated with ustekinumab every 12 or 8weeks, respectively,as compared to18% of patients in the placebo group. 
U 44. tjednu ispitivanja UNIFI-M normalizaciju je postiglo 24% bolesnika liječenih ustekinumabom svakih 12 tjedana, 29% bolesnika liječenih ustekinumabom svakih 8 tjedana te 18% bolesnika koji su primali placebo.
a 41 (19.6%) 84 (40.2%) 
Klinička remisija, 8. tjedan a 41 (19,6%) 84 (40,2%)
Dosing frequency adjustment 
Prilagodba učestalosti primjene lijeka
The clinical development program consisted of one intravenous induction study (referred to as UNIFI-I) with treatment of up to 16 weeks followed by a 
Klinički razvojni program sastojao se od jednog ispitivanja intravenske primjene uvodnog liječenja (UNIFI-I) u trajanju do 16 tjedana, nakon čega je uslijedilo randomizirano ispitivanje supkutane primjene terapije održavanja u trajanju od 44 tjedna (UNIFI-M), što je činilo najmanje 52 tjedna liječenja.
Each vial contains 130 mg of ustekinumab in 26 mL. 
Jedna bočica sadrži 130 mg ustekinumaba u 26 ml otopine.
Patients were randomised to receive treatment with ustekinumab 45 mg, 90 mg, or placebo subcutaneously at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing. 
Bolesnici su bili randomizirani u skupine liječene ustekinumabom od 45 mg, 90 mg ili placebom, primijenjenim supkutano u 0. i 4. tjednu, a potom svakih 12 tjedana.
How much Stelara is given Your doctor will decide how much Stelara you need to use and for how long. 
Liječnik će odrediti koju Vam je dozu Stelare potrebno primijeniti, te trajanje liječenja.
STELARA 90 mg solution for injection Each vial contains 90 mg ustekinumab in 1 mL. 
STELARA 90 mg otopina za injekciju Jedna bočica sadrži 90 mg ustekinumaba u 1 ml otopine.
Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL of solution for injection. 
Jedna napunjena štrcaljka sadrži 45 mg ustekinumaba u 0,5 ml otopine za injekciju.
L-histidine monohydrochloride monohydrate Polysorbate 80 
L-histidinklorid hidrat polisorbat 80 saharoza voda za injekcije
VIAL LABEL TEXT (45 mg) 
TEKST NA NALJEPNICI BOČICE (45 mg)
As part of the monitoring of the patient's psoriasis, physicians should be alert for symptoms of erythrodermic psoriasis or exfoliative dermatitis. 
Liječnici moraju budno pratiti simptome eritrodermne psorijaze ili eksfolijativnog dermatitisa, kao dio postupka nadzora psorijaze u bolesnika.
• Keep the pre-filled syringe in the outer carton in order to protect from light. 
• Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
• the solution in the vial is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow 
• da je otopina u bočici bistra do blago opalescentna (biserno sjajna) i bezbojna do svijetložuta
STELARA 90 mg injection ustekinumab 
STELARA 90 mg otopina za injekciju ustekinumab
At 3 years (week 148), 82% of patients re-randomised to maintenance treatment were PASI 75 responders. 
U 3. godini (148. tjedan), 82% bolesnika koji su ponovno randomizirani na održavanje liječenja, imalo je odgovor PASI 75. U 5. godini (244. tjedan), 80% bolesnika koji su ponovno randomizirani na održavanje liječenja imalo je PASI odgovor
What Stelara looks like and contents of the pack Stelara is a clear, colourless to light yellow concentrate for solution for infusion. 
Stelara je bistri, bezbojni do svijetložuti koncentrat za otopinu za infuziju.
STELARA 45 mg injection ustekinumab 
STELARA 45 mg otopina za injekciju ustekinumab
STELARA 45 mg solution for injection Each vial contains 45 mg ustekinumab in 0.5 mL. 
STELARA 45 mg otopina za injekciju Jedna bočica sadrži 45 mg ustekinumaba u 0,5 ml otopine.
If this happens, please contact your doctor or pharmacist 
kontaktirajte svog liječnika ili ljekarnika
VIAL LABEL TEXT (90 mg) 
TEKST NA NALJEPNICI BOČICE (90 mg)
Each vial contains 90 mg ustekinumab in 1 mL of solution for injection. 
Jedna bočica sadrži 90 mg ustekinumaba u 1 ml otopine za injekciju.
Your doctor will check how well you are before treatment. 
Vam je zdravstveno stanje prije primjene lijeka.
Patients were randomised to receive a single intravenous administration of either the recommended tiered dose of approximately 6 mg/kg (see Table 1, section 4.2), a fixed dose of 130 mg ustekinumab, or placebo at week 0. 
Bolesnici su bili randomizirani na jednokratnu intravensku primjenu ustekinumaba, bilo u preporučenoj dozi određenoj na temelju tjelesne težine koja je iznosila približno 6 mg/kg (vidjeti Tablicu 1, dio 4.2), bilo u fiksnoj dozi od 130 mg, ili na primanje placeba u 0. tjednu.
STELARA 90 mg solution for injection in pre-filled syringe EU/1/08/494/004 
STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki EU/1/08/494/004
Preparing for use of the pre-filled syringe 
Priprema za primjenu napunjene štrcaljke
STELARA 45 mg solution for injection in pre-filled syringe EU/1/08/494/003 
STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki EU/1/08/494/003
A numerically lower number of subjects in the ustekinumab group (0.6%, 2/348) underwent UC disease related surgeries compared with subjects in the placebo group (1.7%, 3/175) through week 44. 
Tijekom 44 tjedna kirurškom zahvatu povezanom s ulceroznim kolitisom bilo je podvrgnut manji broj ispitanika u skupini liječenoj ustekinumabom (0,6%; 2/348) nego u onoj koja je primala placebo (1,7%; 3/175).
Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL. 
Jedna napunjena štrcaljka sadrži 90 mg ustekinumaba u 1 ml otopine.
Each vial contains 45 mg ustekinumab in 0.5 mL of solution for injection. 
Jedna bočica sadrži 45 mg ustekinumaba u 0,5 ml otopine za injekciju.
STELARA 90 mg solution for injection Solution for injection. 
STELARA 90 mg otopina za injekciju Otopina za injekciju.
• it has not passed its expiry date 
• da lijeku nije istekao rok valjanosti
Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL. 
Jedna napunjena štrcaljka sadrži 45 mg ustekinumaba u 0,5 ml otopine.
• If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see section 6 ‘What Stelara looks like and contents of the pack'). 
(pogledajte dio 6 ‘Kako Stelara izgleda i sadržaj pakiranja').
In patients who failed biological therapy In patients who failed both a TNF and vedolizumab Clinical Response 
U bolesnika neuspješno liječenih antagonistima TNFα i vedolizumabom Održan klinički odgovor tijekom 44 tjedna
Table 12: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the induction dose) 
Tablica 12: Sažetak ključnih mjera ishoda za djelotvornost u ispitivanju UNIFI-M (44. tjedan; 52 tjedna od početka primjene uvodne doze) Placebo* N = 175
Maintenance of Clinical Response through week 44 
Održan klinički odgovor tijekom 44 tjedna Klinička remisija bez kortikosteroida Dugotrajna remisija
STELARA 45 mg solution for injection Solution for injection. 
STELARA 45 mg otopina za injekciju Otopina za injekciju.
The primary endpoint in these studies was the proportion of patients who achieved PASI 75 response from baseline at week 12 (see Tables 4 and 5). 
PASI 75 u odnosu na početnu vrijednost (vidjeti Tablicu 4 i 5).
The solution should be visually inspected for particulate matter or discoloration prior to administration. 
Prije primjene otopinu treba vizualno pregledati radi prisutnosti čestica ili promjene boje.
• the number of vials and strength is correct o If your dose is 45 mg or less, you will get one 45 mg vial of Stelara o If your dose is 90 mg you will get two 45 mg vials of Stelara and you will need to give yourself two injections. 
o Ako je Vaša doza 90 mg, dobit ćete dvije bočice Stelare od 45 mg i trebat ćete si dati dvije injekcije.
Table 6: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the induction dose) 
Tablica 6: Sažetak ključnih mjera ishoda za djelotvornost u ispitivanju UNIFI-M (44. tjedan; 52 tjedna od početka primjene uvodne doze) Placebo* N = 175
PASI 50 response N (%) 
ACR 50 odgovor, N (%)
Children weighing less than 60 kg need a dose lower than 45 mg. Make sure you know the proper amount (volume) to remove from the vial and type of syringe needed for dosing. 
Budite sigurni da znate odgovarajuću količinu (volumen) koju treba izvaditi iz bočice i tip štrcaljke potreban za doziranje.
The proportion of patients achieving a modified PsA response criteria (PsARC) response was also significantly greater in the ustekinumab groups compared to placebo at week 24. 
PsA response criteria) bio je značajno veći u skupinama liječenim ustekinumabom u odnosu na placebo u 24. tjednu
• the number of pre-filled syringes and strength is correct o If your dose is 45 mg you will get one 45 mg pre-filled syringe of Stelara o If your dose is 90 mg you will get two 45 mg pre-filled syringes of Stelara and you will need to give yourself two injections. 
o Ako je Vaša doza 90 mg, dobit ćete dvije napunjene štrcaljke Stelare od 45 mg i trebat ćete si dati dvije injekcije.
Combined symptomatic remission and mucosal healing is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1. p<0.001 
Kombinacija simptomatske remisije i cijeljenjasluznicedefiniranaje kao podrezultat za učestalost pražnjenja crijeva 0 ili 1, podrezultat za rektalno krvarenje 0 i endoskopski podrezultat 0 ili 1.
In UNIFI-I a significantly greater proportion of patients were in clinical remission in the ustekinumab treated group compared to placebo at week 8 (Table 11). 
U ispitivanju UNIFI-I, u 8. tjednu je u kliničkoj remisiji bio značajno veći udio bolesnika liječenih ustekinumabom nego onih koji su primili placebo (Tablica 11).
In UNIFI-I a significantly greater proportion of patients were in clinical remission in the ustekinumab treated group compared to placebo at week 8 (Table 5). 
U ispitivanju UNIFI-I, u 8. tjednu je u kliničkoj remisiji bio značajno veći udio bolesnika liječenih ustekinumabom nego onih koji su primili placebo (Tablica 5).
response, N (%) 
PASI 90 odgovor, N (%)
Significantly greater proportions of patients were in clinical remission in both ustekinumab treated groups compared to the placebo group at week 44 (see Table 12). 
U 44. tjednu je u kliničkoj remisiji bio značajno veći udio bolesnika u obje skupine liječene ustekinumabom nego u onoj koja je primala placebo (vidjeti Tablicu 12).
CorticosteroidFree Clinical Remission Durable Remission 
Klinička remisija bez kortikosteroida Klinička remisija u bolesnika:
Each vial contains 90 mg ustekinumab in 1 mL. 
Jedna bočica sadrži 90 mg ustekinumaba u 1 ml otopine.
Each vial contains 45 mg ustekinumab in 0.5 mL. 
Jedna bočica sadrži 45 mg ustekinumaba u 0,5 ml otopine.
Secondary endpoints included PASI 75, PASI 90, change from baseline in Children's Dermatology Life Quality Index (CDLQI), change from baseline in the total scale score of PedsQL (Paediatric Quality of Life Inventory) at week 12. 
Children's Dermatology Life Quality Index (CDLQI)), promjenu u odnosu na početnu vrijednost skale ukupnog rezultata PedsQL (engl.
In these patients, 45 mg was also shown to be efficacious. 
Kod tih bolesnika, doza od 45 mg također se pokazala djelotvornom, međutim, doza od 90 mg pokazala je veću djelotvornost (vidjeti dio 5.1, tablicu 4).
STELARA 90 mg solution for injection in pre-filled syringe Ustekinumab 
STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki ustekinumab
STELARA 45 mg solution for injection in pre-filled syringe Ustekinumab 
STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki ustekinumab
• The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 
• Pomoćne tvari su: EDTA dinatrijeva sol dihidrat, L-histidin, L-histidinklorid hidrat, L-metionin,
Patients who weigh more than 100 kilograms 
Broj bolesnika ≤ 100 kg
• If you have recently had or are going to have a vaccination. 
• ako ste se nedavno cijepili ili ćete se cijepiti.
STELARA 45 mg solution for injection 0.5 mL solution in a type I glass 2 mL vial closed with a coated butyl rubber stopper. 
0,5 ml otopine u bočici od 2 ml, izrađenoj od stakla tipa
STELARA 90 mg solution for injection in pre-filled syringe Solution for injection. 
STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki.
Psoriasis 
• proljev
Table 6 Number of patients who achieved clinical response in Psoriatic arthritis Study 1 (PSUMMIT I) and Study 2 (PSUMMIT II) at week 24 
Tablica 6 Broj bolesnika koji su dostigli klinički odgovor u ispitivanjima psorijatičnog artritisa 1 (PSUMMIT I) i 2 (PSUMMIT II) u 24. tjednu Ispitivanje psorijatičnog artritisa 1 Ispitivanje psorijatičnog artritisa 2 placebo 45 mg 90 mg placebo 45 mg 90 mg
Clinical Remission Clinical Response Corticosteroid-Free Clinical Remission Clinical Remission in patients: in remission at the start of maintenance therapy who entered from study CRD3002 who are Anti-TNFα naïve who entered from study CRD3001 
Koji su ušli iz ispitivanja CRD3002 Koji prethodno nisu primali anti-TNFα terapiju
The solution should be visually inspected for particulate matter or discoloration prior to subcutaneous administration. 
Prije supkutane primjene otopinu treba vizualno pregledati radi prisutnosti čestica ili promjene boje.
Comprehensive instructions for administration are given in the package leaflet. 
Detaljne upute kako primijeniti lijek navedene su u Uputi o lijeku.
STELARA 45 mg solution for injection in pre-filled syringe Solution for injection. 
STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki.
This stops air bubbles forming in the syringe (see Figure 4) 
Na taj način se sprječava stvaranje mjehurića u štrcaljki
Single dose versus multiple doses 
SAŽETAK OPISA SVOJSTAVA LIJEKA
(discard 26 mL sodium chloride for each vial of STELARA needed, for 2 vials-discard 52 mL, for 3 vials- discard 78 mL, for 4 vials- discard 104 mL) 
Izvucite i uklonite volumen 9 mg/ml (0,9%-tne) otopine natrijevog klorida iz infuzijske vrećice od 250 ml, jednak volumenu STELARE koji će se dodati (uklonite 26 ml otopine natrijevog klorida za svaku bočicu STELARE koju trebate, za 2 bočice- uklonite 52 ml, za 3 bočice bacite 78 ml, za 4 bočice- uklonite 104 ml).
The tablets must never be swallowed but should be placed under the tongue and allowed to dissolve, which usually takes five to 10 minutes. 
Tablete se ne smiju nikada progutati već ih treba staviti pod jezik kako bi se omogućila njihova razgradnja, što obično traje 5 do 10 minuta.
Suboxone is used in adults and children over 15 years of age, who are also receiving medical, social and psychological support. 
Suboxone se koristi u odraslih osoba i djece starije od 15 godina koji također primaju medicinsku, socijalnu i psihološku podršku.
The doctor may increase the dose depending on the patient's response but the daily dose should not be higher than 24 mg buprenorphine. 
Liječnik može povećati dozu ovisno o odgovoru bolesnika, no dnevna doza ne smije premašiti 24 mg buprenorfina.
Other information about Suboxone 
Ostale informacije o lijeku Suboxone
Once the patient has been stabilised, the maintenance dose may be reduced gradually and eventually treatment may be stopped. 
Nakon što je bolesnik stabiliziran, doza održavanja može se postupno smanjivati te se terapija može naposljetku prekinuti.
The European Commission granted a marketing authorisation valid throughout the European Union for Suboxone on 26 September 2006. 
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Suboxone na snazi u Europskoj uniji od 26. rujna 2006.
What measures are being taken to ensure the safe and effective use of Suboxone? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Suboxone?
Suboxone buprenorphine / naloxone 
Suboxone buprenorfin / nalokson
Sublingual tablets containing buprenorphine alone have been available in the EU since the mid-1990's for the treatment of opioid addiction. 
Sublingvalne tablete koje sadrže samo buprenorfin dostupne su u EU-u od sredine 1990.-ih godina za liječenje ovisnosti o opioidima.
The CHMP noted that the combination of an opioid analogue with an opioid antagonist is an established strategy for reducing the potential misuse of the medicine. 
CHMP je zaključio da je kombinacija opioidnog analoga s opioidnim antagonistom ustaljena strategija za smanjivanje potencijalne zlouporabe lijeka.
Patients also used a specially designed questionnaire to record their cravings, and the change in the questionnaire score before and at the end of the study was measured. 
Bolesnici su također koristili posebno osmišljene upitnike kako bi zabilježili svoju žudnju, te su utvrđene promjene rezultata upitnika prije i nakon ispitivanja.
Suboxone must not be used in patients with severe respiratory insufficiency (difficulty breathing) or severe liver problems. 
Suboxone se ne smije koristiti u bolesnika s ozbiljnom respiratornom insuficijencijom (poteškoćama s disanjem) ili ozbiljnim jetrenim problemima.
The recommended starting dose is one or two tablets of Suboxone 2 mg/0.5 mg. 
Preporučena početna doza je jedna do dvije tablete lijeka Suboxone od 2 mg/0,5 mg.
This document is a summary of the European public assessment report (EPAR) for Suboxone. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Suboxone.
It is recommended that the patient's liver be checked before starting treatment with Suboxone and should also be monitored regularly during treatment. 
Preporučuje se da se jetra bolesnika pregleda prije početka terapije lijekom Suboxone te se treba redovito kontrolirati tijekom terapije.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Suboxone. 
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Suboxone.
The most common side effects with Suboxone (seen in more than 1 patient in 10) are insomnia (difficulty sleeping), constipation, nausea (feeling sick), sweating, headache and withdrawal syndrome. 
Najčešće nuspojave lijeka Suboxone (uočene u više od 1 bolesnika na 10) su insomnija (poteškoće sa spavanjem), zatvor, mučnina (povraćanje), znojenje, glavobolja i sindrom ustezanja.
A risk management plan has been developed to ensure that Suboxone is used as safely as possible. 
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Suboxone.