FrancophonIA/ELRC3.0 huggingface dataset:
English: Xeplion is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min) (see section 4.4).
Croatian: Xeplion se ne preporučuje u bolesnika s umjerenim ili teškim bubrežnim oštećenjem (klirens kreatinina < 50 ml/min) (vidjeti dio 4.4).
English: Other medicines that have this effect include some medicines used to treat depression or to treat infection, and other antipsychotics.
Croatian: Takav učinak imaju i neki lijekovi za liječenje depresije, za liječenje infekcija te drugi antipsihotici.
English: Xeplion is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min) (see sections 4.2 and 5.2).
Croatian: Ne preporučuje se primjena lijeka Xeplion u bolesnika s umjerenim ili teškim oštećenjem bubrega (klirens kreatinina < 50 ml/min) (vidjeti dijelove 4.2 i 5.2).
English: In the 13-week study involving the 150 mg initiation dosing, the proportion of subjects with an abnormal weight increase ≥ 7% showed a dose-related trend, with a 5% incidence rate in the placebo group compared with rates of 6%, 8% and 13% in the Xeplion 25 mg, 100 mg, and 150 mg groups, respectively.
Croatian: U 13-tjednom ispitivanju s početnom dozom od 150 mg, udio ispitanika s abnormalnim porastom tjelesne težine ≥ 7% imao je trend proporcionalan dozi, pri čemu je incidencija u skupini koja je primala placebo iznosila 5% u usporedbi sa 6%, 8% i 13% u bolesnika koji su primali Xeplion u dozi od 25 mg, 100 mg, odnosno 150 mg.
English: Even if you have previously tolerated oral paliperidone or risperidone, rarely allergic reactions occur after receiving injections of Xeplion.
Croatian: Čak i ako ste prethodno podnosili oralni paliperidon ili risperidon, alergijske reakcije se rijetko javljaju nakon primanja injekcija Xepliona.
English: Events of leucopenia, neutropenia, and agranulocytosis have been reported with Xeplion.
Croatian: Leukopenija, neutropenija i agranulocitoza bile su prijavljene uz Xeplion.
English: • a decrease in body temperature
Croatian: • sniženje tjelesne temperature
English: Although Xeplion was not studied on patients with hepatic impairment, no dose adjustment is required in patients with mild or moderate hepatic impairment.
Croatian: Iako Xeplion nije ispitivan u bolesnika s oštećenjem jetre, nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije.
English: Orthostatic hypotension
Croatian: Ortostatska hipotenzija
English: Since paliperidone is the major active metabolite of risperidone, caution should be exercised when Xeplion is co-administered with risperidone or with oral paliperidone for extended periods of time.
Croatian: Budući da je paliperidon glavni aktivni metabolit risperidona, potreban je oprez kada se lijek Xeplion primjenjuje istodobno s risperidonom ili s oralnim paliperidonom kroz duže vremensko razdoblje.
English: Xeplion 25 mg prolonged release suspension for injection Xeplion 50 mg prolonged release suspension for injection Xeplion 75 mg prolonged release suspension for injection Xeplion 100 mg prolonged release suspension for injection Xeplion 150 mg prolonged release suspension for injection
Croatian: Xeplion 25 mg suspenzija za injekciju s produljenim oslobađanjem Xeplion 50 mg suspenzija za injekciju s produljenim oslobađanjem Xeplion 75 mg suspenzija za injekciju s produljenim oslobađanjem Xeplion 100 mg suspenzija za injekciju s produljenim oslobađanjem Xeplion 150 mg suspenzija za injekciju s produljenim oslobađanjem
English: Date of first authorisation: 04 March 2011 Date of latest renewal:16 December 2015
Croatian: Datum prvog odobrenja: 04. ožujka 2011.
English: The disposition of a single oral dose paliperidone 3 mg prolonged release tablet was studied in subjects with varying degrees of renal function.
Croatian: Izlučivanje jednokratne oralne doze od 3 mg paliperidon tableta s produljenim oslobađanjem ispitivano je u ispitanika s različitim stupnjevima oštećenja bubrežne funkcije.
English: The plasma concentrations of paliperidone are increased in patients with renal impairment and therefore, dose adjustment is recommended in patients with mild renal impairment.
Croatian: U bolesnika s oštećenjem bubrega koncentracije paliperidona u plazmi su povišene te se stoga preporučuje prilagodba doze u bolesnika s blagim oštećenjem bubrega.
English: Xeplion contains the active substance paliperidone which belongs to the class of antipsychotic medicines and is used as a maintenance treatment for the symptoms of schizophrenia in adult patients stabilised on paliperidone or risperidone.
Croatian: Xeplion sadrži aktivnu tvar paliperidon koja pripada skupini antipsihotičkih lijekova i namijenjen je za terapiju održavanja kod simptoma shizofrenije u odraslih bolesnika stabiliziranih paliperidonom ili risperidonom.
English: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicinal products.
Croatian: Antipsihoticima se pripisuje poremećaj sposobnosti organizma da snizi osnovnu tjelesnu temperaturu.
English: • inflammation of the pancreas, swollen tongue, stool incontinence, very hard stool
Croatian: • upala gušterače, otečen jezik, inkontinencija stolice, vrlo tvrda stolica
English: CARDBOARD CARTON
Croatian: KARTONSKA KUTIJA
English: The active substance is paliperidone.
Croatian: Djelatna tvar je paliperidon.
English: Thereafter, you will receive an injection (ranging from 25 mg to 150 mg) in either the upper arm or buttocks once a month.
Croatian: Nakon toga ćete, jednom mjesečno primati injekciju (u dozi od 25 mg do 150 mg) ili u nadlakticu ili u stražnjicu.
English: Other medicines that have this effect include some medicines used to treat the rhythm of the heart or to treat infection, and other antipsychotics.
Croatian: Takav učinak imaju i neki lijekovi za liječenje nepravilnog srčanog ritma, za liječenje infekcija te drugi antipsihotici.
English: Co-administration of oral paliperidone prolonged release tablets at steady-state (12 mg once daily) with divalproex sodium prolonged release tablets (500 mg to 2,000 mg once daily) did not affect the steady-state pharmacokinetics of valproate.
Croatian: Istodobna primjena oralnih paliperidon tableta s produljenim oslobađanjem u stanju dinamičke ravnoteže (12 mg jednom dnevno) s divalproeksnatrij tabletama s produljenim oslobađanjem (500 mg do 2000 mg jednom dnevno) nije utjecala na farmakokinetiku valproata u stanju dinamičke ravnoteže.
English: In vitro studies indicate that CYP2D6 and CYP3A4 may be minimally involved in paliperidone metabolism, but there are no indications in vitro nor in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Croatian: Ispitivanja in vitro ukazuju na to da CYP2D6 i CYP3A4 mogu biti minimalno uključeni u metabolizam paliperidona, ali nema dokaza niti in vitro niti in vivo da ti izoenzimi imaju značajnu ulogu u metabolizmu paliperidona.
English: • rapid heart rate
Croatian: • brzi otkucaji srca
English: • dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood
Croatian: • opasno nizak broj određene vrste bijelih krvnih stanica, koje su u krvi potrebne za obranu od infekcije
English: Paliperidone has not been studied in patients with severe hepatic impairment.
Croatian: Paliperidon nije ispitivan u bolesnika s teškim oštećenjem jetre.
English: Xeplion has not been systematically studied in patients with renal impairment (see section 5.2).
Croatian: Xeplion nije sustavno ispitivan u bolesnika s bubrežnim oštećenjem (vidjeti dio 5.2).
English: The first initiation dose of Xeplion (150 mg) is to be administered on Day 1 in the DELTOID muscle using the needle for DELTOID injection.
Croatian: Prvu početnu dozu lijeka Xeplion (150 mg) treba primijeniti 1. dan u DELTOIDNI mišić, pomoću igle za injiciranje u DELTOIDEUS.
English: In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Croatian: U određenih odraslih bolesnika sa shizofrenijom koji su prethodno imali odgovor na liječenje oralnim oblikom paliperidona ili risperidona, Xeplion se može primijeniti bez prethodne stabilizacije oralnom terapijom ako su psihotični simptomi blagi do umjereni, a potrebno je liječenje dugodjelujućim parenteralnim lijekom.
English: Missed second initiation dose (> 7 weeks from first injection) If more than 7 weeks have elapsed since the first injection of Xeplion, initiate dosing as described for the initial recommended initiation of Xeplion above.
Croatian: Propuštanje druge početne doze (> 7 tjedana nakon prve injekcije) Ako je nakon prve injekcije lijeka Xeplion prošlo više od 7 tjedana, doziranje treba započeti kako je ispred opisano za prvo početno uvođenje lijeka Xeplion.
English: Pack sizes: Pack contains 1 pre-filled syringe and 2 needles.
Croatian: Veličine pakiranja: Pakiranje sadrži 1 napunjenu štrcaljku i 2 igle.
English: • fall.
Croatian: • pad.
English: The initiation regimen for Xeplion (150 mg/100 mg in the deltoid muscle on day 1/day 8) was designed to rapidly attain steady-state paliperidone concentrations when initiating therapy without the use of oral supplementation.
Croatian: Režim uvodnog doziranja lijeka Xeplion (150 mg/100 mg u deltoidni mišić 1./8. dana) oblikovan je tako da se brzo postignu koncentracije paliperidona u stanju dinamičke ravnoteže, bez dodatne primjene oralnih lijekova.
English: Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.
Croatian: Xeplion je indiciran kao terapija održavanja u liječenju shizofrenije kod odraslih bolesnika stabiliziranih paliperidonom ili risperidonom.
English: • hardening of the skin
Croatian: • otvrdnuće kože
English: 59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised in the liver.
Croatian: C-paliperidona s trenutnim otpuštanjem, 59% doze izlučeno je u urinu u nepromijenjenom obliku, što upućuje na činjenicu da se paliperidon u jetri ne metabolizira u velikoj mjeri.
English: Caution should be exercised when paliperidone is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QT interval.
Croatian: Potreban je oprez kod propisivanja paliperidona bolesnicima s poznatom bolešću srca i krvnih žila ili obiteljskom anamnezom produljenja QT intervala, kao i kod istodobne primjene lijekova koji produljuju QT interval.
English: Even if you have previously tolerated oral risperidone or oral paliperidone, rarely allergic reactions occur after receiving injections of paliperidone.
Croatian: Čak i ako ste prethodno podnosili oralni risperidon ili oralni paliperidon, rijetke alergijske reakcije javile su se nakon primjene injekcije paliperidona.
English: Xeplion should be used with caution in elderly patients with dementia with risk factors for stroke.
Croatian: Xeplion treba primjenjivati uz oprez u bolesnika s demencijom koji imaju faktore rizika za moždani udar.
English: Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Croatian: Incidencija mortaliteta iznosila je 4% u bolesnika liječenih risperidonom, u usporedbi s 3,1% u bolesnika koji su primali placebo.
English: In vitro studies have shown that paliperidone is a P-gp substrate and a weak inhibitor of P-gp at high concentrations.
Croatian: In vitro ispitivanja pokazala su kako je paliperidon supstrat P-glikoproteina i u visokim koncentracijama slab inhibitor P-glikoproteina.
English: • tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue,
Croatian: • tardivna diskinezija (trzajni pokreti lica, jezika i drugih dijelova tijela koje ne možete kontrolirati).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially sodium-free.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: 50 mg every 2 weeks
Croatian: 50 mg svaka 2 tjedna
English: Discard the syringe with needle appropriately.
Croatian: Štrcaljku s iglom uklonite na odgovarajući način.
English: Caution is advised when prescribing Xeplion with medicinal products known to prolong the QT interval, e.g. class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g. amiodarone, sotalol), some antihistaminics, some other antipsychotics and some antimalarials (e.g. mefloquine).
Croatian: Preporučuje se oprez kad se Xeplion propisuje zajedno s lijekovima koji produljuju QT interval, npr. antiaritmicima IA skupine (npr. kinidin, dizopiramid), antiaritmicima III skupine (npr. amiodaron, sotalol), nekim antihistaminicima, nekim drugim antipsihoticima i nekim antimalaricima (npr. meflokin).
English: Treatment initiation pack: Each pack contains 1 pack of Xeplion 150 mg and 1 pack of Xeplion 100 mg.
Croatian: Pakiranje za početak liječenja: Jedno pakiranje sadrži 1 pakiranje lijeka Xeplion 150 mg i 1 pakiranje lijeka Xeplion 100 mg.
English: A total of 410 stabilised patients were randomised to either Xeplion (median duration 171 days [range 1 day to 407 days]) or to placebo (median duration 105 days [range 8 days to 441 days]) until they experienced a relapse of schizophrenia symptoms in the variable length double-blind phase.
Croatian: U dvostruko slijepoj fazi različitog trajanja, ukupno 410 stabiliziranih bolesnika randomizirano je ili u skupinu koja je primala Xeplion (medijan trajanja 171 dan [raspon 1 do 407 dana]) ili u skupinu koja je primala placebo (medijan trajanja 105 dana [raspon 8 do 441 dan]) sve dok nisu ponovno nastupili simptomi shizofrenije.
English: If your doctor is switching you from risperidone long acting injection to this medicine, you will receive the first injection of this medicine (ranging from 25 mg to 150 mg) in either the upper arm or buttocks on the date that your next injection was scheduled.
Croatian: Ukoliko Vam liječnik mijenja terapiju s dugodjelujuće injekcije risperidona na ovaj lijek, prvu injekciju ovog lijeka (u dozi od 25 mg do 150 mg) primit ćete ili u nadlakticu ili u stražnjicu, na dan kad ste trebali primiti sljedeću injekciju.
English: Anaphylactic reaction
Croatian: Anafilaktičke reakcije
English: Injection site reactions
Croatian: Reakcije na mjestu primjene
English: Neonates exposed to paliperidone during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Croatian: U novorođenčadi koja su tijekom trećeg tromjesečja trudnoće izložena paliperidonu, nakon rođenja postoji rizik pojave nuspojava koje uključuju ekstrapiramidne i/ili simptome ustezanja, koje mogu varirati u težini i trajanju.
English: • experience a severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an ‘anaphylactic reaction').
Croatian: • doživite tešku alergijsku reakciju čija su obilježja vrućica, oticanje usta, lica, usana ili jezika, nedostatak zraka, svrbež, osip kože te ponekad pad krvnog tlaka (može se razviti u anafilaktičku reakciju).
English: Switching from risperidone long acting injection to Xeplion When switching patients from risperidone long acting injection, initiate Xeplion therapy in place of the next scheduled injection.
Croatian: Prijelaz s risperidona u obliku injekcija s produljenim djelovanjem na Xeplion Bolesniku koji prelazi s risperidona u obliku injekcija s produljenim djelovanjem, Xeplion treba uvesti umjesto sljedeće predviđene injekcije.
English: Population pharmacokinetics analyses indicated no discernible difference on the apparent clearance of paliperidone after administration of oral paliperidone between extensive metabolisers and poor metabolisers of CYP2D6 substrates.
Croatian: Analiza populacijske farmakokinetike pokazala je da nakon peroralne primjene paliperdona nema zamjetne razlike u prividnom klirensu paliperidona između brzih i sporih metabolizatora supstrata CYP2D6.
English: The experience from risperidone cited below is considered valid also for paliperidone.
Croatian: Smatra se da iskustvo iz ispitivanja risperidona prikazano u daljnjem tekstu vrijedi i za paliperidon.
English: 25 mg every 2 weeks
Croatian: 25 mg svaka 2 tjedna
English: The recommended monthly maintenance dose is 50 mg with a range of 25 to 100 mg based on patient tolerability and/or efficacy.
Croatian: Preporučena mjesečna doza održavanja je 50 mg, s rasponom od 25 mg do 100 mg, ovisno o podnošljivosti i/ili djelotvornosti u pojedinog bolesnika.
English: Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% on average in mild (CrCl = 50 to < 80 mL/min), 64% in moderate (CrCl = 30 to < 50 mL/min), and 71% in severe (CrCl = 10 to < 30 mL/min) renal impairment, corresponding to an average increase in exposure (AUCinf) of 1.5, 2.6, and 4.8 fold, respectively, compared to healthy subjects.
Croatian: U osoba s poremećajem bubrežne funkcije ukupni klirens paliperidona bio je smanjen za prosječno 32% kod blagog (CrCl = 50 do < 80 ml/min), 64% kod umjerenog (CrCl = 30 do < 50 ml/min) te 71% kod teškog (CrCl = 10 do < 30 ml/min) oštećenja bubrega, što odgovara prosječnom porastu izloženosti (AUCinf) za 1,5; 2,6 odnosno 4,8 puta u odnosu na zdrave ispitanike.
English: • abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth,
Croatian: • nelagoda u trbuhu, infekcija želuca ili crijeva, otežano gutanje, suha usta
English: Co-administration of a single dose of an oral paliperidone prolonged release tablet 12 mg with divalproex sodium prolonged release tablets (two 500 mg tablets once daily) resulted in an increase of approximately 50% in the Cmax and AUC of paliperidone, likely as a result of increased oral absorption.
Croatian: Istodobna primjena jedne doze oralnih paliperidon tableta s produljenim oslobađanjem od 12 mg s divalproeksnatrij tabletama s produljenim oslobađanjem (dvije tablete od 500 mg jednom na dan) dovela je do povećanja Cmax i AUC paliperidona za oko 50%, što je vjerojatno rezultat povećane oralne apsorpcije.
English: Xeplion should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Croatian: Xeplion treba primjenjivati uz oprez u bolesnika s napadajima u povijesti bolesti ili drugim stanjima koja mogu sniziti konvulzivni prag.
English: The total exposure of paliperidone following Xeplion administration was dose-proportional over a 25-150 mg dose range, and less than dose-proportional for Cmax for doses exceeding 50 mg.
Croatian: Nakon primjene lijeka Xeplion, ukupna izloženost paliperidonu bila je proporcionalna dozi u rasponu doza od 25-150 mg, a Cmax je bila manje proporcionalna za doze veće od 50 mg.
English: • symptoms of drug withdrawal
Croatian: • simptomi ustezanja lijeka
English: Renal and urinary disorders urinary incontinence, pollakiuria, dysuria urinary retention
Croatian: Poremećaji bubrega i mokraćnog sustava urinarna inkontinencija, polakizurija, dizurija urinarna retencija
English: Deltoid muscle administration
Croatian: Primjena u deltoidni mišić
English: Vascular disorders hypertension hypotension, orthostatic hypotension venous thrombosis, flushing pulmonary embolism, ischaemia
Croatian: Krvožilni poremećaji hipertenzija hipotenzija, ortostatska hipotenzija venska tromboza, navale crvenila plućna embolija ishemija
English: When symptoms of high prolactin occur, they may include (in men) breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction;
Croatian: Kada se pojave simptomi visokog prolaktina, oni mogu uključiti: (u muškaraca) oticanje dojki, poteškoće s postizanjem ili održavanjem erekcija ili druge spolne disfunkcije, (u žena) nelagodu u dojkama, curenje mlijeka iz dojki, propuštanje menstruacije ili druge probleme s ciklusom.
English: QT prolongation, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia), sudden unexplained death, cardiac arrest, and Torsade de pointes may occur with antipsychotics.
Croatian: Kod primjene antipsihotika može doći do produljenja QT intervala, ventrikularnih aritmija (ventrikularne fibrilacije, ventrikularne tahikardije), iznenadne neobjašnjive smrti, zastoja srca i torsade de pointes.
English: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotic medicinal products (frequency unknown).
Croatian: Uz liječenje antipsihoticima zabilježeni su slučajevi venske tromboembolije, uključujući slučajeve plućne embolije i duboke venske tromboze (učestalost je nepoznata).
English: • cough, stuffy nose
Croatian: • kašalj, začepljen nos
English: Prolonged release suspension for injection.
Croatian: Suspenzija za injekciju s produljenim oslobađanjem.
English: Neuroleptic Malignant Syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated serum creatine phosphokinase levels has been reported to occur with paliperidone.
Croatian: Kod primjene paliperidona može se javiti maligni neuroleptički sindrom (MNS), obilježen hipertermijom, rigiditetom mišića, nestabilnošću autonomnog živčanog sustava, promjenama svijesti i povišenim razinama kreatin fosfokinaze u serumu.
English: • dead skin cells at the injection site and an ulcer at the injection site.
Croatian: • odumiranje stanica kože na mjestu injekcije i čir na mjestu injekcije.
English: Reporting suspected adverse reactions after authorisation of the medical product is important.
Croatian: Nakon dobivanja odobrenja lijeka važno je prijavljivanje sumnji na njegove nuspojave.
English: Xeplion can help alleviate the symptoms of your disease and stop your symptoms from coming back.
Croatian: Vaše bolesti i spriječiti povratak simptoma.
English: EPS included a pooled analysis of the following terms: parkinsonism (includes salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, glabellar reflex abnormal, and parkinsonian rest tremor), akathisia (includes akathisia, restlessness, hyperkinesia, and restless leg syndrome), dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia (includes dystonia, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus), and tremor.
Croatian: EPS je uključio objedinjenu analizu sljedećih izraza: Parkinsonizam (koji uključuje hipersekreciju sline, mišićno-koštanu ukočenost, parkinsonizam, slinjenje, rigidnost s fenomenom zupčanika, bradikineziju, hipokineziju, izraz lica u obliku maske, mišićnu napetost, akineziju, nuhalni rigiditet, rigiditet mišića, hod tipičan za parkinsonizam, abnormalan glabelarni refleks, te parkinsonski tremor u mirovanju), akatizija (uključuje akatiziju, nemir, hiperkineziju i sindrom nemirnih nogu), diskinezija (diskinezija, mišićni trzaji, koreoatetoza, atetoza i mioklonus), distonija (uključuje distoniju, hipertoniju, tortikolis, nevoljne mišićne kontrakcije, kontrakturu mišića, blefarospazam, okulogiraciju, paralizu jezika, spazam lica, laringospazam, miotoniju, opistotonus, orofaringealni spazam, pleurototonus, spazam jezika i trizmus), te tremor.
English: (day 8) time point.
Croatian: (vidjeti dio 4.8).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING TREATMENT INITIATION PACK OUTER LABEL (WITH BLUE BOX)
Croatian: LIJEČENJA VANJSKA NALJEPNICA (S PLAVIM OKVIROM)