FrancophonIA/ELRC3.0 huggingface dataset:
English: Deutschland Sanofi-Aventis Deutschland GmbH
Croatian: Nederland sanofi-aventis Netherlands B.V.
English: Each infusion will take approximately 4 hours.
Croatian: Svaka infuzija će trajati otprilike 4 sata.
English: Genotoxic and carcinogenic potential are not expected.
Croatian: Ne očekuje se genotoksičan i karcinogeni potencijal.
English: The dose you receive is based on your body weight.
Croatian: Doza koju ćete primiti temelji se na Vašoj tjelesnoj težini.
English: In addition, an updated RMP should be submitted:
Croatian: Nadalje, nadopunjen RMP treba biti dostavljen:
English: Unopened vials: 3 years.
Croatian: Neotvorene bočice: 3 godine.
English: 46 Galli Drive, Novato, CA 94949 United States of America
Croatian: 46 Galli Drive, Novato, CA 94949 Sjedinjene Američke Države
English: This leaflet was last revised in MM/YYYY
Croatian: Ova uputa je zadnji puta revidirana u MM/YYYY
English: Date of latest renewal: 26 January 2011
Croatian: Datum posljednje obnove odobrenja: 26. siječnja 2011.
English: Module 5 - Clinical
Croatian: Modul 5 - klinički
English: Currently available data are described in section 5.1.
Croatian: Trenutno dostupni podaci su opisani u djelu 5.1.
English: If you forget to take this medicine
Croatian: Ako ste zaboravili uzeti ovaj lijek
English: Risk Management Plan
Croatian: Plan upravljanja rizicima
English: Your doctor may also give you additional medicines to manage any allergic reactions.
Croatian: Liječnik Vam također može dati dodatne lijekove za liječenje alergijske reakcije.
English: Although limited by the very small number of patients that were enrolled, the conclusions that can be drawn from this study are the following:
Croatian: Iako limitirani malim brojem uključenih bolesnika, zaključci koji su se mogli izvući iz ove studije bili su sljedeći:
English: Pharmacokinetic parameters in Phase 1 patients have remained stable over the long term (through at least 194 weeks).
Croatian: Farmakokinetički parametri bolesnika u fazi 1 su ostali stabilni tijekom dužeg vremena (kroz barem 194 tjedna).
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Molimo obavijestite svog liječnika ako uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Peri- and post-natal toxicity has not been investigated.
Croatian: Peri- i post-natalna toksičnost nije bila istražena.
English: Urinary GAG levels decreased by more than 70%, consistent with results in older patients.
Croatian: Razina GAG u urinu smanjila se za više od 70 %, što je u skladu s rezultatima kod starijih bolesnika.
English: Not all package sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakovanja.
English: Pack sizes: 1 and 6 vials.
Croatian: Veličina pakovanja: 1 i 6 bočica.
English: Other side effects with an unknown frequency:
Croatian: Druge nuspojave s nepoznatom učestalosti:
English: Other measures (urinary GAG, antibodies) are assessed more frequently.
Croatian: Druge mjere (urinarni GAG, antitijela) se procjenjuju češće.
English: The majority (42/59; 71%) of patients experienced at least one Adverse Drug Reaction.
Croatian: Većina (42/59; 71%) bolesnika je iskusila barem jednu nuspojavu na lijek.
English: Substudies will be conducted within the CSP that will:
Croatian: Unutar CSP-a provest će se pod ispitivanja koja će:
English: What this medicine is and what it is used for
Croatian: Što je ovaj lijek i za što se koristi
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave, iako se neće javiti kod svakoga.
English: 53/54 patients (98%) were positive for IgG antibodies to galsulfase.
Croatian: 53/54 bolesnika (98%) su bili pozitivni na IgG antitijela na galsulfazu.
English: Improved hearing was noted in at least one ear for all four subjects.
Croatian: Poboljšanje sluha zabilježeno je na barem jednom uhu kod svih četiri bolesnika.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Pitajte svog liječnika ili ljekarnika za savjet prije uzimanja bilo kojeg lijeka.
English: • At the request of the European Medicines Agency
Croatian: • Na traženje Europske agencije za lijekove.
English: If you get any of these symptoms, or other symptoms not listed in this leaflet, tell your doctor immediately.
Croatian: Ako primijetite bilo koji od ovih simptoma, ili druge simptome koji nisu navedeni u ovoj uputi, odmah se obratite svom liječniku.
English: Specification,Pharmacovigilance Plan or risk minimisation activities
Croatian: Farmakovigilancijski plan ili aktivnosti smanjenja rizika
English: A key issue is to treat children aged <5 years suffering from a severe form of the disease, even though children <5 years were not included in the pivotal phase 3 study.
Croatian: Ključno pitanje je liječenje djece mlađe od 5 godina koja pate od teškog oblika bolesti, iako djeca mlađa od 5 godina nisu bila uključena u ključnu studiju faze 3.
English: The molecule contains 6 N-linked oligosaccharide modification sites.
Croatian: Molekula sadrži 6 N-vezanih oligosaharidnih modifikacijskih mjesta.
English: The current medical standards for emergency treatment are to be observed.
Croatian: Ono treba biti u skladu s trenutnim medicinskim standardima za hitno liječenje.
English: Several measures will be implemented to assess the Naglazyme dose.
Croatian: Nekoliko mjera će se primijeniti kako bi se procijenila doza Naglazyme-a.
English: As a result, these substances do not get broken down and processed by the body as they should.
Croatian: Posljedično tome, te se tvari ne razgrađuju i metaboliziraju u tijelu kao što bi trebalo.
English: This medicine contains a recombinant enzyme called galsulfase.
Croatian: Ovaj lijek sadrži rekombinirani enzim koji se naziva galsulfaza.
English: What this medicine is and what it is used for What you need to know before you are given this medicine How this medicine is given
Croatian: Što je ovaj lijek i za što se koristi Što morate znati prije nego počnete primati ovaj lijek Kako se ovaj lijek daje
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryo-foetal development (see section 5.3).
Croatian: Studije na životinjama ne pokazuju direktni ili indirektni štetni učinak lijeka na trudnoću ili na embrio fetalni razvoj (vidjeti dio 5.3).
English: This medicine has been authorised under “exceptional circumstances”.
Croatian: Ovaj lijek je odobren pod "iznimnim okolnostima".
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator Do not freeze
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku Ne zamrzavati
English: A comprehensive antibody analysis based on data from three clinical studies has been carried out in 48 patients.
Croatian: Sveobuhvatna analiza antitijela temeljena na podacima iz tri kliničke studije provedena je na 48 bolesnika.
English: - Please talk to your doctor if you experience muscle pain, numbness in your arms or legs, or any bowel or bladder problems as these may be caused by pressure on your spinal cord.
Croatian: - Molimo, razgovarajte s Vašim liječnikom ako osjetite bol u mišićima, obamrlost u rukama ili nogama, ili bilo kakve probleme s crijevima ili mokraćnim mjehurom, jer oni mogu biti uzrokovani pritiskom na Vašu leđnu moždinu.
English: This can replace the natural enzyme which is lacking in MPS VI patients.
Croatian: On može zamijeniti prirodni enzim koji nedostaje u bolesnika s MPS VI.
English: The final study report under this CSP will be submitted by 31 July 2020.
Croatian: Završni izvještaj ispitivanja u skladu s Programom kliničkog nadzora podnijet će se do 31. srpnja 2020.
English: They accumulate in many tissues in the body, which causes the symptoms of MPS VI.
Croatian: Umjesto toga, nakupljaju se u mnogim tkivima u tijelu što uzrokuje simptome MPS VI.
English: - If you have an allergic reaction your doctor may slow down, or stop, your infusion.
Croatian: Ako dođe do alergijske reakcije liječnik može usporiti ili zaustaviti infuziju.
English: It did not prevent the progression of skeletal dysplasia and development of hernias and did not prevent the progression of corneal clouding.
Croatian: Nije preveniralo progresiju displazije kostiju i razvoj hernija i nije spriječilo razvoj zamućenja rožnice.
English: When you experience such a reaction, you should immediately contact your doctor.
Croatian: Kada osjetite takvu reakciju, trebate odmah kontaktirati Vašeg liječnika.
English: Limited data are available in patients < 1 year of age (see section 5.1).
Croatian: Dostupni su ograničeni podaci o liječenju bolesnika mlađih od 1 godine života (vidjeti dio 5.1).
English: The mean ( SD) elimination half-life (t1/2) was 22.8 ( 10.7) minutes at Week 24.
Croatian: Srednje (± SD) poluvrijeme eliminacije (t1/2) je bilo 22,8 (± 10,7) minuta u 24 tjednu.
English: An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management System for medicinal products for human use.
Croatian: Nadopunjeni Plan upravljanja rizicima treba biti pripremljen u skladu s CHMP smjernicama za Sustav upravljanja rizicima za lijekove za humanu uporabu.
English: Galsulfase is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Croatian: Galsulfaza je protein i očekuje se da će se metabolički razgraditi putem peptidne hidrolize.
English: Growth rate remained normal over this limited follow-up period.
Croatian: Brzina rasta ostala je normalna tijekom ovog ograničenog praćenja.
English: You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids) or to reduce fever (antipyretics).
Croatian: Možda ćete trebati dobiti dodatne lijekove da bi se spriječila alergijska reakcija (kao na primjer antihistaminike i/ili kortikosteroide) ili da bi se smanjila vrućica (antipiretike).
English: This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
Croatian: To znači da zbog rijetkosti bolesti nije bilo moguće dobiti potpune informacije o ovom lijeku.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 January 2006
Croatian: DATUM PRVOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET/ DATUM OBNOVE ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Datum prvog odobrenja: 24. siječnja 2006.
English: If you have any further questions on the use of this medicine, ask your doctor.
Croatian: Ako imate daljnjih pitanja o korištenju ovog lijeka, obratite se svom liječniku.
English: Store in a refrigerator (2°C - 8°C).
Croatian: Čuvati u hladnjaku (2°C do 8°C).
English: Common reactions have a frequency of 1/100 to <1/10.
Croatian: Česte nuspojave imaju učestalost ≥1/100 do <1/10.
English: Do not take Naglazyme if it contains visible particles.
Croatian: Nemojte primijeniti Naglazyme ako sadrži vidljive čestice.
English: Patients received either 1 mg/kg of galsulfase or placebo every week for a total of 24 weeks.
Croatian: Bolesnici su dobivali ili 1 mg/kg galsulfaze ili placebo svaki tjedan, ukupno 24 tjedna.
English: The infusion can be restarted with a reduction of the infusion rate to 50% - 25% of the rate at which the reaction occurred.
Croatian: Infuziju se može opet započeti sa smanjenom brzinom infuzije do 50% - 25% brzine pri kojoj je došlo do reakcije.
English: As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease.
Croatian: Kao i kod svih lizosomskih genetskih poremećaja, od primarne važnosti je, osobito u težim oblicima, započeti liječenje što je ranije moguće, prije pojave ireverzibilnih kliničkih simptoma bolesti.
English: As with any intravenous protein medicinal product, severe allergic-type hypersensitivity reactions are possible.
Croatian: Kao i kod svakog drugog intravenskog proteinskog lijeka, moguće su teške reakcije preosjetljivosti alergijskog tipa.
English: Institution of positive-airway pressure during sleep as well as potential tracheostomy in clinically appropriate situations should also be considered.
Croatian: Uvođenje pozitivnog tlaka zraka kroz dišne putove tijekom sna, kao i moguću traheotomiju u klinički prihvatljivim situacijama, mora se također uzeti u obzir.
English: Specific Obligations:
Croatian: Posebni zahtjevi:
English: As there is little experience on resumption of treatment following prolonged interruption, caution is to be used due to the theoretical increased risk of hypersensitivity reaction.
Croatian: Kako ima malo iskustva s nastavkom liječenja nakon produžene stanke, treba biti oprezan zbog teoretski povećanog rizika reakcije preosjetljivosti.
English: Pharyngitis1, gastroenteritis1
Croatian: Faringitis1, gastroenteritis1
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: Thirty-eight patients subsequently enrolled in an Open Label extension study where they received 1 mg/kg of galsulfase every week.
Croatian: Trideset i osam bolesnika je bilo kasnije uključeno u proširenu otvorenu studiju gdje su dobivali 1 mg/kg galsulfaze svaki tjedan.
English: Hypertension1
Croatian: Hipertenzija1
English: Based on data obtained during Naglazyme clinical trials, the majority of patients are expected to develop IgG antibodies to galsulfase within 4-8 weeks of treatment initiation.
Croatian: Temeljeno na podacima dobivenim tijekom kliničkih ispitivanja lijeka Naglazyme, očekuje se da će većina bolesnika razviti IgG antitijela na galsulfazu unutar 4-8 tjedana od početka liječenja.
English: Spinal/cervical cord compression (SCC) with resultant myelopathy is a known and serious complication that can be due to MPS VI.
Croatian: Kompresija leđne/cervikalne moždine i mijelopatija koja iz toga proizlazi je poznata i ozbiljna komplikacija koja može biti izazvana MPS VI.
English: • High blood pressure
Croatian: • Visoki krvni tlak
English: • Poor reflexes
Croatian: • Oslabljeni refleksi
English: Infusion reactions began as early as Week 1 and as late as Week 146 of Naglazyme treatment, and occurred during multiple infusions though not always in consecutive weeks.
Croatian: Reakcije na infuziju su započele rano, već tijekom 1. tjedna, ali i kasno kao u 146. tjednu primjene Naglazyme i pojavile su se tijekom višekratnih primjena iako ne uvijek uzastopno svaki tjedan.
English: Warnings and precautions - If you are treated with Naglazyme, you may develop infusion-associated reactions.
Croatian: Upozorenja i mjere opreza - Ako budete liječeni s Naglazymom možete razviti reakciju na infuziju.
English: There is no evidence for special considerations when Naglazyme is administered to the paediatric population.
Croatian: Nema dokaza da postoje posebne okolnosti kada se Naglazyme primjenjuje pedijatrijskoj populaciji.
English: The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to hydrolyze the accumulated substrate and to prevent further accumulation.
Croatian: Smisao terapije nadoknade enzima je povratiti nivo enzimatske aktivnosti dovoljne za hidrolizu nakupljenog supstrata i sprječavanje daljnjeg nakupljanja.
English: In four patients <1 year of age, the overall safety profile of a higher dose (2 mg/kg/week) did not differ in a clinically meaningful manner from that of the recommended 1 mg/kg/week dose, and was consistent with the safety profile of Naglazyme in older children.
Croatian: U četiri bolesnika mlađih od godinu dana, ukupni profil sigurnosti veće doze (2 mg/kg/tjedan) se nije razlikovao značajno u kliničkom smislu od onoga pri preporučenoj dozi od 1 mg/kg/tjedan, i bio je u skladu s profilom sigurnosti Naglazymea kod starije djece.
English: MedDRA Preferred Term
Croatian: MedDRA Preporučeni naziv
English: This medicine may improve the symptoms of MPS VI.
Croatian: Ovaj lijek može poboljšati simptome MPS VI bolesti.
English: After intravenous infusion, galsulfase is rapidly removed from the circulation and taken up by cells into lysosomes, most likely via mannose-6 phosphate receptors.
Croatian: Nakon intravenske infuzije, galsulfaza se brzo uklanja iz cirkulacije i unosi se u stanice u lizosome, najvjerojatnije preko manoze-6-fosfatnih receptora.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mg/5 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA 5 mg/5 ml
English: The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.
Croatian: Nositelj odobrenja ispunit će sljedeći program ispitivanja unutar zadanog vremenskog okvira, čiji će rezultati činiti osnovu za godišnju procjenu omjera koristi/rizika.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children.
Croatian: POSEBNO UPOZORENJE DA LIJEK TREBA ČUVATI IZVAN DOHVATA I POGLEDA DJECE
English: Infusion reactions, defined as adverse reactions occurring during Naglazyme infusions or until the end of the infusion day, were observed in 33 (56%) of the 59 patients treated with Naglazyme across five clinical studies.
Croatian: Reakcije na infuziju, definirane kao nuspojave koje se javljaju tijekom infuzije lijeka Naglazyme ili do kraja dana kada je infuzija primijenjena, zabilježene su u 33 (56%) od 59 bolesnika liječenih Naglazymeom tijekom 5 kliničkih studija.
English: Your doctor or nurse will administer Naglazyme to you.
Croatian: Vaš liječnik ili medicinska sestra će Vam dati Naglazyme.
English: What you need to know before you are given this medicine
Croatian: Što morate znati prije nego počnete primati ovaj lijek
English: The cause of clinical relevance of the hepatic toxicity (bile duct hyperplasia / periportal inflammation) seen at clinically relevant doses in the repeated dose monkey toxicity study is not known.
Croatian: Uzrok kliničke važnosti toksičnog oštećenja jetre (hiperplazija žučnog kanala / periportalna upala) viđena kod klinički relevantnih doza u studiji toksičnosti ponovljene doze u majmuna, nije poznata.
English: The majority of the patients presented with short stature, impaired endurance, and musculoskeletal symptoms.
Croatian: Većina bolesnika je bila niskog rasta, oslabljene izdržljivosti i sa mišićno-koštanim simptomima.
English: Detailed clinical status information will be collected at study entry and on an annual basis for at least 15 years.
Croatian: Detaljne informacije o kliničkom statusu sakupit će se kod ulaska u ispitivanje i jednom godišnje tijekom najmanje 15 godina.
English: Samples for total antibody will be collected at specific intervals.
Croatian: Uzorci ukupnih antitijela prikupljat će se u određenim intervalima.
English: The safety and efficacy of Naglazyme was assessed in a randomised, double blind, placebo controlled, Phase 3 study of 39 MPS VI patients, ranging in age from 5 to 29 years.
Croatian: Sigurnost i djelotvornost Naglazyme je procijenjena kroz randomiziranu, dvostruko-slijepu placebokontroliranu studiju faze 3 na 39 MPS VI bolesnika u dobi od 5 do 29 godina.
English: In case of a single severe IAR, the infusion should be stopped until the symptoms are resolved and treatment with antihistamines and paracetamol should be considered.
Croatian: U slučaju samo jednokratne teške reakcije na infuziju, infuziju se mora prekinuti dok simptomi ne prođu i mora se razmisliti o liječenju antihistaminicima i paracetamolom.
English: When using 100 ml bags, the volume of Naglazyme may be added directly to the infusion bag.
Croatian: Kada se koriste vrećice od 100 ml, volumen Naglazyme-a se može dodati direktno u infuzijsku vrećicu.
English: If you have missed a Naglazyme infusion, please contact your doctor.
Croatian: Ako ste propustili infuziju Naglazyme, molimo kontaktirajte svog liječnika.
English: The pharmacokinetics of galsulfase were evaluated in 13 patients with MPS VI who received 1 mg/kg of galsulfase as a 4 hour infusion.
Croatian: Farmakokinetika galsulfaze je bila procjenjivana kod 13 bolesnika sa MPS VI koji su dobivali 1 mg/kg galsulfaze tijekom 4 sata infuzije.
English: The safety and efficacy of Naglazyme in patients older than 65 years has not been established, and no alternative dose regimen can be recommended in these patients.
Croatian: Sigurnost i djelotvornost lijeka Naglazyme u bolesnika starijih od 65 godina nije utvrđena te se ne može preporučiti alternativni režim doziranja kod tih bolesnika.
English: In an additional Phase 4, randomised, two-dose level study, four MPS VI patients <1 year of age were treated at 1 or 2 mg/kg/week for 53 to 153 weeks.
Croatian: U dodatnoj randomiziranoj studiji faze 4 s dvije doze, četiri MPS VI bolesnika mlađih od jedne godine života bili su liječeni s dozama 1 ili 2 mg/kg/tjedan tijekom 53 do 153 tjedna.
English: This medicine contains Sodium
Croatian: Ovaj lijek sadrži natrij
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of galsulfase in a clinically significant way.
Croatian: Dosljedno tome, oštećenje jetre ne bi trebalo imati utjecaj na farmakokinetiku galsulfaze na klinički značajan način.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom
English: Several patients have received their total dose of Naglazyme at approximately twice the recommended infusion rate without apparent adverse events.
Croatian: Nekoliko bolesnika je dobilo svoju ukupnu dozu Naglazymea otprilike dvaput brže od preporučene brzine infuzije bez očitih nuspojava.
English: Very common side effects (these may affect more than 1 in 10 people):
Croatian: Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba):
English: Renal elimination of galsulfase is considered a minor pathway for clearance (see section 4.2).
Croatian: Bubrežna eliminacija galsulfaze se smatra manje značajnim putem klirensa (vidjeti dio 4.2).
English: Preparation of the Naglazyme Infusion (Use Aseptic Technique)
Croatian: Priprema infuzije Naglazyme-a (mora se koristiti aseptička tehnika)
English: The CSP data will be analysed at yearly intervals and results will be submitted as annual reports.
Croatian: CSP podaci će se analizirati svake godine i rezultati će biti predani kao godišnji izvještaji.
English: - This medicine has not been tested in patients with kidney or liver problems.
Croatian: Ovaj lijek nije ispitivan na bolesnicima koji imaju problema s bubrezima ili jetrom.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB08
Croatian: Farmakoterapijska skupina: Ostali lijekovi s djelovanjem na probavni sustav i metabolizam, enzimi, ATK oznaka: A16AB08
English: C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Croatian: POSEBNE OBVEZE KOJE MORA ISPUNITI NOSITELJ ODOBRENJA
English: • Low blood pressure
Croatian: • Niski krvni tlak
English: Patients who could walk more than 5 meters (m) but less than 250 m in 6 minutes of a 12 Minute Walk test or less than 400 m at the 12 minute time point at baseline were enrolled in the study.
Croatian: U studiju su bili uključeni bolesnici koji su mogli prehodati više od 5 metara (m), ali manje od 250 m u 6 minuta u Testu 12 minuta hodanja, ili manje od 400 m unutar 12 minuta prilikom početnog pregleda.
English: • When new information is received that may impact on the current Safety
Croatian: • Kada su primljene nove informacije koje mogu utjecati na važeći Sigurnosni profil lijeka,
English: • Shock
Croatian: • Šok