FrancophonIA/ELRC3.0 huggingface dataset:
English: Elderly patients are more likely to have decreased renal function; therefore caution should be exercised when treating elderly patients with Emtriva.
Croatian: Kod starijih je pacijenata veća vjerojatnost da imaju smanjenu funkciju bubrega, pa je stoga potrebno primijeniti oprez kad se stariji pacijenti liječe Emtrivom.
English: Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) which works by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the HIV virus to reproduce itself.
Croatian: Emtricitabin je nukleozidni inhibitor reverzne transkriptaze (NRTI) koji djeluje tako da ometa normalan rad enzima (reverzne transkriptaze) koji je ključan za reprodukciju virusa HIV-a.
English: Adults: The recommended dose of Emtriva is one 200 mg hard capsule, taken orally, once daily.
Croatian: Odrasli: Preporučena doza Emtrive je jedna tvrda kapsula od 200 mg, primijenjena peroralno, a uzima se jedanput na dan.
English: If you accidentally take too much Emtriva oral solution, contact your doctor or nearest emergency department for advice.
Croatian: Ako slučajno uzmete previše oralne otopine Emtriva, obratite se svom liječniku ili otiđite po savjet u hitnu službu najbliže bolnice.
English: Patients with renal impairment: Emtricitabine is eliminated by renal excretion and exposure to emtricitabine was significantly increased in patients with renal insufficiency.
Croatian: Pacijenti s oštećenjem funkcije bubrega: Emtricitabin se eliminira izlučivanjem putem bubrega i izloženost emtricitabinu znatno se povećava u pacijenata s insuficijencijom bubrega.
English: In addition to the adverse reactions reported in adults (see section 4.8, Tabulated summary of adverse reactions), the following adverse reactions were observed more frequently in paediatric patients: anaemia was common (9.5%) and skin discolouration (increased pigmentation) was very common (31.8%) in paediatric patients.
Croatian: Uz nuspojave zabilježene u odraslih (vidjeti dio 4.8, Tablični prikaz nuspojava), u pedijatrijskih pacijenata češće su zabilježene sljedeće nuspojave: anemija je bila česta (9,5%), a promjena boje kože (povećana pigmentacija) bila je vrlo česta (31,8%) u pedijatrijskih pacijenata.
English: Before starting treatment, your doctor may order blood tests to assess kidney function and may advise you to take the capsules less often or prescribe Emtriva oral solution.
Croatian: Prije početka liječenja, liječnik će možda zatražiti krvne pretrage da bi ocijenio funkciju bubrega te Vam može preporučiti da rjeđe uzimate kapsule ili Vam može propisati oralnu otopinu Emtriva.
English: • increased triglycerides (fatty acids), bile or sugar in the blood
Croatian: • povišene trigliceride (masne kiseline), bilirubin (žučna boja) ili šećer u krvi • poteškoće s jetrom i gušteračom
English: The pharmacokinetics of emtricitabine have not been studied in non-HBV infected subjects with varying degrees of hepatic insufficiency.
Croatian: Farmakokinetika emtricitabina nije ispitana u ispitanika koji nisu zaraženi virusom HBV-a, a koji imaju različit stupanj insuficijencije jetre.
English: Based on the results of these in vitro experiments and the known elimination pathways of emtricitabine, the potential for CYP450 mediated interactions involving emtricitabine with other medicinal products is low.
Croatian: Na temelju rezultata tih ispitivanja in vitro i poznatih puteva eliminacije emtricitabina smatra se kako je potencijal za interakciju emtricitabina s drugim lijekovima, posredstvom CYP450, malen.
English: Patients co-infected with HIV and HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with emtricitabine for evidence of exacerbations of hepatitis.
Croatian: U pacijenata istovremeno inficiranih HIV-om i HBV-om nužno je pažljivo pratiti pokazatelje egzacerbacije hepatitisa, kliničkom i laboratorijskom kontrolom od najmanje nekoliko mjeseci nakon prekida liječenja emtricitabinom.
English: Contact your doctor again before you restart taking Emtriva oral solution.
Croatian: Obratite se liječniku prije nego što ponovno počnete uzimati oralnu otopinu Emtriva.
English: There is no experience of the use of emtricitabine in patients who are failing their current regimen or who have failed multiple regimens.
Croatian: Nema iskustva primjene emtricitabina u pacijenata u kojih trenutno liječenje nije uspješno ili u kojih višestruki režimi liječenja nisu bili uspješni.
English: The methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).
Croatian: Metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216) mogu uzrokovati alergijske reakcije (koje mogu biti zakašnjele).
English: The mean AUC in 77 infants, children and adolescents receiving 6 mg/kg emtricitabine once daily as oral solution or 200 mg emtricitabine as hard capsules once daily was similar to the mean AUC of 10.0 µg·h/mL in 20 adults receiving 200 mg hard capsules once daily.
Croatian: Srednji AUC u 77 dojenčadi, djece i adolescenata, koji su primali 6 mg/kg emtricitabina jedanput na dan kao oralnu otopinu ili 200 mg emtricitabina u tvrdim kapsulama jedanput na dan, bio je sličan srednjem AUC-u od 10,0 µg·h/mL u 20 odraslih pacijenata koji su primali tvrde kapsule od 200 mg jedanput na dan.
English: Do not use this medicine after the expiry date which is stated on the bottle, blister pack and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci, blister pakiranju i kutiji iza oznake „Rok valjanosti“.
English: However, limited data are available on the efficacy and safety of emtricitabine (as a 200 mg hard capsule once daily) in patients who are co-infected with HIV and HBV.
Croatian: No podaci o djelotvornosti i sigurnosti emtricitabina (koji se uzima kao tvrda kapsula od 200 mg jedanput na dan), u pacijenata s istovremenom infekcijom
English: In combination studies of emtricitabine with protease inhibitors (PIs), nucleoside, nucleotide and non-nucleoside analogue inhibitors of HIV reverse transcriptase, additive to synergistic effects were observed.
Croatian: Pri ispitivanjima emtricitabina u kombinaciji s inhibitorima proteaze, nukleozidnim, nukleotidnim i nenukleozidnim analozima inhibitora reverzne transkriptaze HIV-a, opaženi su aditivni do sinergistički učinci.
English: Recommended dose of Emtriva 10 mg/mL oral solution every 24 hours
Croatian: Preporučena doza Emtriva 10 mg/mL oralne otopine svaka 24 sata
English: Intracellular pharmacokinetics: In a clinical study, the intracellular half-life of emtricitabine-triphosphate in PBMCs was 39 hours.
Croatian: Unutarstanična farmakokinetika: Unutarstanični poluvijek emtricitabin-trifosfata u mononuklearnim stanicama periferne krvi (PBMC) tijekom kliničkog ispitivanja iznosio je 39 sati.
English: In antiretroviral treatment-naïve adults, emtricitabine was significantly superior to stavudine when both medicinal products were taken in combination with didanosine and efavirenz through 48 weeks of treatment.
Croatian: U odraslih koji nisu prethodno liječeni antiretrovirusnim lijekovima, emtricitabin je bio značajno superioran stavudinu prilikom pojedinačnog kombiniranja s didanozinom i efavirenzom tijekom 48 tjedana liječenja.
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Emtriva (see section 4.2).
Croatian: U starijih pacijenata postoji veća vjerojatnost da imaju smanjenu funkciju bubrega, pa je stoga nužan oprez prilikom liječenja starijih pacijenata Emtrivom (vidjeti dio 4.2).
English: Emtriva is also available as a 10 mg/mL oral solution for use in infants aged 4 months and over, children and patients who are unable to swallow hard capsules and patients with renal insufficiency.
Croatian: Emtriva je dostupna i kao oralna otopina od 10 mg/mL za dojenčad od 4 mjeseca i više, djecu i pacijente koji ne mogu progutati tvrde kapsule te pacijente s insuficijencijom bubrega.
English: This active substance is an antiretroviral medicine which is used to treat HIV infection.
Croatian: Ta je djelatna tvar antiretrovirusni lijek koji se koristi za liječenje infekcija virusom HIV-a.
English: diarrhoea, nausea
Croatian: proljev, mučnina
English: Table 1: Dose interval guidelines for 200 mg hard capsules adjusted according to creatinine clearance
Croatian: Tablica 1: Smjernice za interval doziranja tvrdih kapsula od 200 mg prilagođen prema klirensu kreatinina
English: • headache, diarrhoea, feeling sick (nausea)
Croatian: • glavobolja, proljev, mučnina
English: Renal insufficiency: Emtricitabine is eliminated by renal excretion and exposure to emtricitabine was significantly increased in patients with renal insufficiency (see section 5.2).
Croatian: Insuficijencija bubrega: Emtricitabin se eliminira izlučivanjem putem bubrega i izloženost emtricitabinu znatno se povećava u pacijenata s insuficijencijom bubrega (vidjeti dio 5.2).
English: Children given emtricitabine also experienced changes in skin colour including darkening of the skin in patches, very commonly and anaemia (low red blood cell count), commonly.
Croatian: Djeca kojoj je davan emtricitabin također su vrlo često imala promjene boje kože, uključujući mjestimično tamnjenje kože te često anemiju (nizak broj crvenih krvnih stanica).
English: These are only suitable for patients who weigh at least 33 kg and can swallow hard capsules.
Croatian: One su prikladne samo za pacijente tjelesne težine od najmanje 33 kg koji mogu progutati tvrde kapsule.
English: This is because the active substance in this medicine passes into human breast milk.
Croatian: Djelatna tvar iz ovoga lijeka prelazi u majčino mlijeko.
English: Patients with renal insufficiency can also be managed by administration of Emtriva 200 mg hard capsules at modified dose intervals.
Croatian: Pacijenti s insuficijencijom bubrega mogu se liječiti i primjenom Emtriva 200 mg tvrdih kapsula uz prilagođene intervale doziranja.
English: Emtricitabine is principally eliminated by the kidney via glomerular filtration and active tubular secretion.
Croatian: Emtricitabin se prvenstveno eliminira putem bubrega glomerularnom filtracijom i aktivnom tubularnom sekrecijom.
English: If you do miss a dose of Emtriva within 12 hours of when it is usually taken, take it as soon as you can, and then take your next dose at its regular time.
Croatian: Ako ipak propustite uzeti jednu dozu Emtrive, a to ste primijetili prije nego je proteklo 12 sati od vremena kada Emtrivu obično uzimate, uzmite dozu čim možete, a potom sljedeću dozu uzmite u redovito vrijeme.
English: Administration of Emtriva 200 mg hard capsules with a high-fat meal or administration of Emtriva 10 mg/mL oral solution with a low-fat or high-fat meal did not affect systemic exposure (AUC0-∞) of emtricitabine; therefore Emtriva 200 mg hard capsules and Emtriva 10 mg/mL oral solution may be administered with or without food.
Croatian: Primjena Emtriva 200 mg tvrdih kapsula uz obrok s visokim udjelom masnoće ili primjena Emtriva 10 mg/mL oralne otopine uz obrok s niskim ili visokim udjelom masnoće nije imala utjecaj na sistemsku izloženost (AUC0-∞) emtricitabina, stoga se Emtriva 200 mg tvrde kapsule i Emtriva
English: • The active substance is emtricitabine.
Croatian: • Djelatna tvar je emtricitabin.
English: Emtriva oral solution contains sunset yellow (E110) which may cause allergic reactions, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Croatian: Oralna otopina Emtriva sadrži boju sunset yellow (E110) koja može uzrokovati alergijske reakcije, te metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216) koji mogu uzrokovati alergijske reakcije (koje mogu biti zakašnjele).
English: Emtriva 200 mg hard capsules may be taken with or without food.
Croatian: Doziranje Emtriva 200 mg tvrde kapsule mogu se uzimati s hranom ili bez nje.
English: Please also refer to the Summaries of Product Characteristics of the other antiretroviral medicinal products used in the combination regimen.
Croatian: Pročitajte i sažetke opisa svojstava lijeka za druge antiretrovirusne lijekove koji se koriste u kombiniranom režimu liječenja.
English: Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infected adults and children aged 4 months and over.
Croatian: Emtriva je indicirana u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje odraslih osoba i djece u dobi od 4 mjeseca i više, inficiranih virusom humane imunodeficijencije-1 (HIV-1).
English: Each mL contains 10 mg of emtricitabine.
Croatian: Svaki mL sadrži 10 mg emtricitabina.
English: Caution should be exercised when emtricitabine is co-administered with medicinal products that are eliminated by active tubular secretion as such co-administration may lead to an increase in serum concentrations of either emtricitabine or a co-administered medicinal product, due to competition for this elimination pathway (see section 4.5).
Croatian: Nužno je oprezno postupati pri istovremenoj primjeni emtricitabina i lijekova koji se eliminiraju aktivnom tubularnom sekrecijom jer takva istovremena primjena može povećati serumsku koncentraciju emtricitabina ili istovremeno primijenjenog lijeka, zbog natjecanja za taj put eliminacije (vidjeti dio 4.5).
English: Patients with renal insufficiency can also be managed by administration of Emtriva 10 mg/mL oral solution to provide a reduced daily dose of emtricitabine.
Croatian: Pacijenti s insuficijencijom bubrega mogu se liječiti i primjenom Emtriva 10 mg/mL oralne otopine da bi se smanjila dnevna doza emtricitabina.
English: If a patient misses a dose of Emtriva by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
Croatian: Ako pacijent propusti uzeti dozu Emtrive u roku duljem od 12 sati, a već je blizu vrijeme za uzimanje sljedeće doze, pacijent ne treba uzeti propuštenu dozu nego jednostavno nastaviti uzimati lijek prema svom uobičajenom rasporedu.
English: When tested for activity against laboratory strains of HBV, the IC50 value for emtricitabine was in the range of 0.01 to 0.04 µmol/l.
Croatian: Prilikom ispitivanja aktivnosti na laboratorijskim sojevima HBV-a vrijednost IK50 emtricitabina bila je u rasponu od 0,01 do 0,04 µmol/L.
English: The blood levels obtained after taking one Emtriva 200 mg hard capsule are similar to those obtained after taking 24 mL of the oral solution.
Croatian: Razine u krvi izmjerene nakon uzimanja jedne tvrde kapsule Emtriva 200 mg slične su razinama izmjerenima nakon uzimanja 24 mL oralne otopine.
English: If a patient misses a dose of Emtriva within 12 hours of the time it is usually taken, the patient should take Emtriva with or without food as soon as possible and resume their normal dosing schedule.
Croatian: Ako pacijent propusti uzeti dozu Emtrive, a prošlo je manje od 12 sati od uobičajenog vremena uzimanja doze, pacijent treba što prije uzeti Emtrivu s hranom ili bez nje i potom ju nastaviti uzimati prema svom normalnom rasporedu.
English: Capsule contents: microcrystalline cellulose (E460), crospovidone, magnesium stearate (E572), povidone (E1201)
Croatian: Sadržaj kapsule: mikrokristalična celuloza (E460), krospovidon, magnezijev stearat (E572),
English: BLISTER CARTON LABELLING
Croatian: OZNAČIVANJE NA KUTIJI BLISTERA
English: This indication is based on studies in treatment-naïve patients and treatment-experienced patients with stable virological control.
Croatian: Ova je indikacija utemeljena na ispitivanjima provedenima na pacijentima koji nisu bili prethodno liječeni te pacijentima koji su bili liječeni, a u kojih je virološka kontrola bila stabilna.
English: Indigotine (E132) Titanium dioxide (E171)
Croatian: Ovojnica kapsule želatina indigotin (E132) titanijev dioksid (E171)
English: Tell your doctor about any of the following side effects: Most frequent side effects
Croatian: Obavijestite liječnika o bilo kojoj od sljedećih nuspojava:
English: Please refer to the package leaflet of the other antiretrovirals for guidance on how to take those medicines.
Croatian: Molimo da pročitate upute o lijeku drugih antiretrovirusnih lijekova koje daju smjernice o načinu uzimanja tih lijekova.
English: In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbations of hepatitis may lead to hepatic decompensation.
Croatian: U pacijenata s uznapredovalom bolešću jetre ili cirozom jetre ne preporučuje se prekid liječenja jer egzacerbacija hepatitisa nakon liječenja može dovesti do dekompenzacije jetre.
English: One 200 mg hard capsule every 72 hours
Croatian: Jedna tvrda kapsula od 200 mg svaka 72 sata
English: Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may lead to an increase in serum concentrations of either emtricitabine or a co-administered medicinal product due to competition for this elimination pathway.
Croatian: Istovremena primjena emtricitabina i lijekova koji se eliminiraju aktivnom tubularnom sekrecijom može uzrokovati povećanje serumske koncentracije emtricitabina, ili lijeka koji se istovremeno primjenjuje, zbog kompetitivnosti za taj put eliminacije.
English: This medicinal product contains 36 mg of sodium per 24 mL, equivalent to 1.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži 36 mg natrija po 24 mL, što odgovara 1,8% maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO-a za odraslu osobu.
English: Emtricitabine in combination with other antiretroviral agents, including nucleoside analogues, non-nucleoside analogues and PIs, has been shown to be effective in the treatment of HIV infection in treatment-naïve patients and treatment-experienced patients with stable virological control.
Croatian: Emtricitabin se u kombinaciji s drugim antiretrovirusnim lijekovima, uključujući nukleozidne analoge, nenukleozidne analoge i inhibitore proteaze, pokazao djelotvornim pri liječenju infekcije HIV-a i u pacijenata koji nisu bili prethodno liječeni te u pacijenata koji su već liječeni, a u kojih je virološka kontrola stabilna.
English: Emtricitabine has been shown to be excreted in human milk.
Croatian: Dojenje Pokazalo se da se emtricitabin izlučuje u majčino mlijeko.
English: Please refer to the package leaflets of the other antiretrovirals for guidance on how to take those medicines.
Croatian: Molimo da pročitate upute o lijeku drugih antiretrovirusnih lijekova za informacije o načinu uzimanja tih lijekova.
English: Your doctor may also order blood tests during treatment to monitor your kidneys.
Croatian: Liječnik može zatražiti krvne pretrage i tijekom liječenja u cilju praćenja funkcije bubrega.
English: Children aged 4 months and over, who weigh at least 33 kg may either take one 200 mg hard capsule daily or may take emtricitabine as the oral solution up to a maximum of 240 mg once daily.
Croatian: Djeca u dobi od 4 mjeseca i starija, tjelesne mase najmanje 33 kg mogu uzimati jednu tvrdu kapsulu od 200 mg na dan ili mogu emtricitabin uzimati kao oralnu otopinu do maksimalne doze od 240 mg jedanput na dan.
English: Assessment of adverse reactions from clinical study data is based on experience in three studies in adults (n = 1,479) and three paediatric studies (n = 169).
Croatian: Procjena nuspojava iz podataka prikupljenih kliničkim ispitivanjima temelji se na iskustvima prikupljenima tijekom tri ispitivanja provedenih na odraslim (n = 1479) te tri pedijatrijska ispitivanja (n = 169).
English: Skin and subcutaneous tissue disorders: Common:
Croatian: Poremećaji kože i potkožnog tkiva:
English: Printing ink containing Black iron oxide (E172) Shellac (E904)
Croatian: Tinta za označavanje sadrži: crni željezov oksid (E172), šelak (E904)
English: Paediatric population: The recommended dose of Emtriva for children aged 4 months and over and adolescents up to 18 years of age weighing at least 33 kg who are able to swallow hard capsules is one 200 mg hard capsule, taken orally, once daily.
Croatian: Pedijatrijska populacija: Za djecu u dobi od 4 mjeseca i više te za adolescente do 18 godina starosti tjelesne mase najmanje 33 kg, koji mogu progutati tvrde kapsule, preporučena doza Emtrive je jedna tvrda kapsula od 200 mg, primijenjena peroralno, a uzima se jedanput na dan.
English: Table 1: Daily doses of Emtriva 10 mg/mL oral solution adjusted according to creatinine clearance
Croatian: Tablica 1: Dnevne doze Emtriva 10 mg/mL oralne otopine prilagođene prema klirensu kreatinina
English: Metabolic parameters: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Croatian: Metabolički parametri: Tijekom antiretrovirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi (vidjeti dio 4.4).
English: Emtriva is also available as an oral solution for use in children and infants aged 4 months and over, patients who have difficulty in swallowing and patients with kidney problems.
Croatian: Emtriva je dostupna i kao oralna otopina za djecu i dojenčad od 4 mjeseca i stariju, pacijente koji imaju poteškoća s gutanjem te pacijente s insuficijencijom bubrega.
English: elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia Hepatobiliary disorders: Common:
Croatian: povišena amilaza uključujući povišenu amilazu gušterače, povišena serumska lipaza, povraćanje, bolovi u trbuhu, dispepsija
English: Paediatric population: The recommended dose of Emtriva 10 mg/mL oral solution is 6 mg/kg up to a maximum of 240 mg (24 mL) once daily.
Croatian: Pedijatrijska populacija: Preporučena doza Emtriva 10 mg/mL oralne otopine iznosi 6 mg/kg do najviše 240 mg (24 mL) jedanput na dan.
English: The adverse reactions with suspected (at least possible) relationship to treatment in adults from clinical trial and post-marketing experience are listed in Table 2 below by body system organ class and frequency.
Croatian: Nuspojave, za koje se na temelju kliničkih ispitivanja na odraslima i iskustva nakon stavljanja lijeka u promet, sumnja (ili smatra da je moguća) povezanost s liječenjem, navedene su niže u Tablici 2 po organskim sustavima i učestalosti.
English: In 20 HIV infected subjects receiving 200 mg emtricitabine daily as hard capsules, steady-state plasma emtricitabine peak concentrations (Cmax), trough concentrations (Cmin) and area under the plasma concentration time curve over a 24-hour dosing interval (AUC) were 1.8 ± 0.7 µg/mL, 0.09 ± 0.07 µg/mL and 10.0 ± 3.1 µg·h/mL, respectively.
Croatian: 200 mg emtricitabina u obliku tvrdih kapsula, vršna koncentracija emtricitabina u stanju dinamičke ravnoteže u plazmi (Cmax) iznosila je 1,8 ± 0,7 µg/mL, najniža koncentracija (Cmin) iznosila je 0,09 ± 0,07 µg/mL, a područje ispod vremenske krivulje koncentracije u plazmi tijekom 24-satnog intervala doziranja (AUC) iznosilo je 10,0 ± 3,1 µg·h/mL.
English: Pack size: 30 hard capsules.
Croatian: Veličina pakiranja: 30 tvrdih kapsula.
English: • The other ingredients are: cotton candy flavouring, disodium edetate, hydrochloric acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sodium phosphate monobasic hydrate, sunset yellow (E110), purified water, xylitol (E967).
Croatian: Drugi sastojci su: aroma šećerne vate, dinatrijev edetat, kloridna kiselina, metilparahidroksibenzoat (E218), propilenglikol, propilparahidroksibenzoat (E216), natrijev hidroksid, natrijev fosfat monobazični hidrat, boja sunset yellow (E110), pročišćena voda,
English: Emtriva oral solution contains:
Croatian: Oralna otopina Emtriva sadrži:
English: Amber-coloured polyethylene terephthalate (PET) bottle with a child-resistant closure.
Croatian: Boca od polietilen tereftalata (PET) jantarne boje sa sigurnosnim zatvaračem.