FrancophonIA/ELRC3.0 huggingface dataset:
English: Purevax RCPCh is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Croatian: Purevax RCPCh je dostupan kao liofilizat (prašak smrznut sušenjem) i otapalo od kojih se pravi suspenzija za injekciju.
English: In the field, the studies of Purevax RCPCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination.
Croatian: Na terenu, ispitivanja cjepiva Purevax RCPCh fokusirala su se na temeljni raspored cijepljenja (2 injekcije u razmaku od 3 do 4 tjedna) te na docjepljivanje.
English: Purevax RCPCh is a veterinary vaccine that contains:
Croatian: Purevax RCP je veterinarsko cjepivo koje sadrži:
English: In laboratory conditions Purevax RCPCh was demonstrated to provide protection against the diseases listed above.
Croatian: U laboratorijskim uvjetima je dokazano da Purevax RCP osigurava zaštitu protiv prethodno spomenutih bolesti.
English: • attenuated feline panleucopenia virus (PLI IV).
Croatian: • oslabljeni virus mačje panleukopenije (PLI IV).
English: • attenuated Chlamydophila felis (905 strain),
Croatian: • oslabljene bakterije Chlamydophila felis (soj 905),
English: Purevax RCPCh contains small amounts of weakened or killed viruses and bacteria that cause feline rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
Croatian: Purevax RCPCh sadrži male količine oslabljenih ili mrtvih virusa i bakterija koji uzrokuju mačji rinotraheitis, kalicivirozu, klamidiozu i panleukopeniju.
English: The effectiveness of Purevax RCPCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis or parvovirus.
Croatian: Učinkovitost cjepiva Purevax RCPCh ispitivana je u nekoliko ispitivanja u laboratorijskim uvjetima gdje su mačke cijepljene i inficirane herpesvirusom, kalicivirusom, virusom C. felis ili parvovirusom.
English: Other information about Purevax RCPCh:
Croatian: Ostale informacije o VMP-u Purevax RCPCh:
English: What benefit has Purevax RCPCh shown during the studies?
Croatian: Koje je koristi Purevax RCP pokazao tijekom ispitivanja?
English: Purevax RCPCh is a vaccine.
Croatian: Purevax RCPCh je cjepivo.
English: In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.
Croatian: U ispitivanju koje je ispitivalo docjepljivanje, razine protutijela na herpesvirus rinotraheitisa, infekciju kalicivirusom, mačju leukopeniju te C. felis ostale su stabilne pri visokim razinama ili su blago povećane.
English: What is the risk associated with Purevax RCPCh?
Croatian: Koji su rizici povezani s cjepivom Purevax RCPCh?
English: For a full list of the side-effects reported with Purevax RCPCh, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni VMP-a Purevax RCPCh potražite u uputi o VMP-u.
English: What is Purevax RCPCh?
Croatian: Što je Purevax RCPCh?
English: Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated) and feline calicivirosis (inactivated) vaccine
Croatian: Cjepivo protiv mačjeg rinotraheitisa, mačje panleukopenije (živo oslabljeno) i mačje kaliciviroze (inaktivirano)
English: Why has Purevax RCPCh been approved?
Croatian: Zašto je lijek Purevax RCPCh odobren?
English: • feline chlamydiosis (a flu-like illness caused by the bacterium C. felis),
Croatian: • mačje klamidioze (bolesti nalik gripi koju uzrokuje C. felis),
English: What is Purevax RCPCh used for?
Croatian: Za što se koristi Purevax RCPCh?
English: How does Purevax RCPCh work?
Croatian: Kako djeluje Purevax RCPCh?
English: How has Purevax RCPCh been studied?
Croatian: Kako je lijek Purevax RCPCh ispitivan?
English: A further study was carried out in 15 female patients.
Croatian: Provedeno je daljnje ispitivanje u 15 ženskih bolesnika.
English: The full EPAR for Replagal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Replagal nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Replagal is given once every 2 weeks as an infusion of 0.2 mg per kilogram body weight over 40 minutes.
Croatian: Replagal se primjenjuje jednom svakih 2 tjedna kao infuzija od 0,2 mg po kilogramu tjelesne težine tijekom 40 minuta.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 20 July 2015.
Croatian: Tvrtka je dostavila dodatne zatražene informacije, tako da je dodano „u iznimnim okolnostima” dana 20. srpnja 2015
English: Replagal has also been evaluated in additional studies involving 38 children aged 7 years or above.
Croatian: Replagal je također ocijenjen u daljnjim ispitivanjima koja su obuhvatila 38 djece u dobi od 7 godina ili starijih.
English: Replagal was originally authorised under ‘exceptional circumstances', because as the disease is rare, limited information was available at the time of approval.
Croatian: Replagal je prvobitno odobren u „iznimnim okolnostima” zbog toga što su, iz znanstvenih razloga, u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Replagal on 3 August 2001.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Replagal na snazi u Europskoj uniji od 3. kolovoza 2001.
English: Children who received Replagal had no unexpected increase in heart mass, and the levels of Gb3 in their blood were reduced.
Croatian: Djeca koja su primila lijek Replagal nisu imala neočekivanih povećanja u srčanoj masi, a koncentracije Gb3 u njihovoj krvi su se smanjile.
English: Replagal agalsidase alfa
Croatian: Replagal agalzidaza alfa
English: The active substance in Replagal, agalsidase alfa, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme.
Croatian: Djelatna tvar lijeka Replagal, agalzidaza alfa, jest kopija ljudskog enzima, proizvedena metodom poznatom pod nazivom "tehnologija rekombinantne DNK": proizvodi ga stanice koje su primile gen (DNK), koji im omogućuje stvaranje enzima.
English: For more information about treatment with Replagal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Replagal pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: After 6 months of treatment, Replagal significantly reduced pain in patients compared with placebo.
Croatian: Nakon 6 mjeseci terapije, Replagal je značajno smanjio bol u bolesnika u usporedbi s placebom.
English: People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems, and stroke.
Croatian: Osobe s Fabryjevom bolesti mogu imati široko raspon znakova i simptoma, uključujući ozbiljna stanja poput zatajenja bubrega, srčanih problema i moždanog udara.
English: Why has Replagal been approved?
Croatian: Zašto je Replagal odobren?
English: Other information about Replagal
Croatian: Ostale informacije o lijeku Replagal
English: These include chills, headache, nausea, pyrexia (fever), pain and discomfort, flushing and fatigue (tiredness), and are rarely severe.
Croatian: Ove nuspojave uključuju zimicu, mučninu, pireksiju (vrućicu), bol i nelagodu, znojenje o iscrpljenost (umor), te su rijetko ozbiljne.
English: 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 Replagal.
Croatian: 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 Replagal.
English: It is available as a concentrate to be made into solution for infusion (drip) into a vein.
Croatian: Postoji kao koncentrat za suspenziju za infuziju (drip u venu).
English: The first study measured the effects of Replagal on pain while the second study measured its effect on the mass of the left ventricle (heart muscle), a measure of the amount of Gb3 in the heart cells.
Croatian: Prvo je ispitivanje izmjerilo djelovanje lijeka Replagal na bol dok je drugo ispitivanje izmjerilo njegovo djelovanje na masu lijevog ventrikula (srčanog mišića), mjera količine Gb3 u srčanim stanicama.
English: If the enzyme is not present, Gb3 cannot be broken down and it builds up in the body's cells, such as kidney cells.
Croatian: Ako enzim nije prisutan, Gb3 se ne može razgrađivati i ugrađuje se u stanice tijela poput stanica bubrega.
English: The most common side effects with Replagal (seen in more than 1 patient in 10) are infusionassociated reactions.
Croatian: Najčešće nuspojave lijeka Replagal (može se javiti u više od 1 na 10 osoba) su reakcije povezane s infuzijom..
English: This is a summary of the European public assessment report (EPAR) for Replagal.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Replagal.
English: Replagal has been compared with placebo (a dummy treatment) in two main studies involving a total of 40 male patients.
Croatian: Replagal je uspoređen s placebom (prividnim terapijom) u dva glavna ispitivanja koja su obuhvatila ukupno 40 muških bolesnika.
English: The effect of giving doses weekly rather than every two weeks was also investigated.
Croatian: Istraženo je i djelovanje primjene tjednih doza u odnosu na primjenu svaka dva tjedna.
English: The replacement enzyme helps to break down the Gb3 and stops it building up in the cells.
Croatian: Zamjenski enzim pomaže pri razgradnji Gb3 i zaustavlja njegovu ugradnju u stanice.
English: Enzyme replacement therapy provides patients with the enzyme they are lacking.
Croatian: Enzimska zamjenska terapija osigurava bolesniku enzime koji mu nedostaju.
English: Replagal is designed to replace the human enzyme alpha-galactosidase A, which is lacking in people with Fabry disease.
Croatian: Replagal je dizajniran kako bi zamijenio ljudski enzim alfa-galaktozidaza A, koji nedostaje osobama s Fabryjevom bolesti.
English: Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Replagal.
Croatian: Samo liječnici koji su iskusni u liječenju bolesnika s Fabryjevom bolesti ili drugom nasljednom metaboličkom bolesti smiju primjenjivati lijek Replagal.
English: The CHMP decided that Replagal's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Replagal nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: What is the risk associated with Replagal?
Croatian: Koji su rizici povezani s lijekom Replagal?
English: Replagal is medicine that contains the active substance agalsidase alfa.
Croatian: Replagal je lijek koji sadrži djelatnu tvar agalzidaza alfa.
English: The CHMP decided that for patients with Fabry disease treatment with Replagal might provide longterm clinical benefits.
Croatian: CHMP je odlučio da bolesnici s Fabryevom bolesti mogu imati dugoročne koristi od terapije lijekom Replagal.
English: Replagal is used to treat patients who have Fabry disease, a rare inherited disorder.
Croatian: Replagal se koristi uza liječenje bolesnika s Fabryjevom bolesti, rijetkim nasljednim poremećajem.
English: Replagal reduced left ventricle mass by an average of 11.5 g while patients receiving placebo had an increase in left ventricular mass of 21.8 g. The effects in female patients were comparable to those in male patients and weekly dosing had no advantage over standard doses.
Croatian: Replagal je smanjio masu lijevog ventrikula prosječno za 11,5 g dok su bolesnici koji su primali placebo imali povećanje u masi lijevog ventrikula od 21,8 g.
English: Replagal is an enzyme replacement therapy.
Croatian: Replagal je enzimska zamjenska terapija.
English: Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (Gb3 or GL-3).
Croatian: Ovaj enzim normalno razgrađuje masnu tvar naziva globotriaosilkeramid (Gb3 ili GL-3).
English: What benefit has Replagal shown during the studies?
Croatian: Koje su koristi lijeka Replagal utvrđene u ispitivanjima?
English: What is Replagal used for?
Croatian: Za što se Replagal koristi?
English: For the full list of all side effects and restrictions with Replagal, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Replagal potražite u uputi o lijeku.
English: What is Replagal?
Croatian: Što je Replagal?
English: How is Replagal used?
Croatian: Kako se Replagal koristi?
English: How does Replagal work?
Croatian: Kako djeluje Replagal?
English: How has Replagal been studied?
Croatian: Kako je Replagal ispitivan?
English: The volume of distribution is 53 - 93 litres.
Croatian: Volumen distribucije iznosi 53-93 litre.
English: Sabervel should not be given to children under 18 years of age.
Croatian: Sabervel se ne smije davati djeci mlađoj od 18 godina.
English: Risk Management Plan (RMP) Not applicable
Croatian: Plan upravljanja rizicima (RMP)
English: This medicine should not be used in children and adolescents (under 18 years) because the safety and efficacy have not yet been fully established.
Croatian: Ovaj lijek ne smiju uzimati djeca i adolescenti (mlađi od 18 godina), jer sigurnost i djelotvornost još nisu u potpunosti utvrđene.
English: Always take Sabervel exactly as your doctor has told you.
Croatian: Uvijek uzmite Sabervel točno onako kako Vam je rekao liječnik.
English: • This medicine has been prescribed for you.
Croatian: Ovaj je lijek propisan Vama.
English: • if you suffer from heart problems
Croatian: • Ako imate srčanih problema.
English: The terminal elimination half-life of irbesartan is 11 - 15 hours.
Croatian: Krajnje poluvrijeme eliminacije irbesartana iznosi 11-15 sati.
English: If you take more Sabervel than you should:
Croatian: Ako uzmete više Sabervela nego što se trebali
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first Authorization: 13 April 2012
Croatian: Datum prvog odobrenja: 13. travnja, 2012.
English: Like all medicines, Sabervel can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, Sabervel može uzrokovati nuspojave, iako ih neće svi dobiti.
English: hepatitis, abnormal liver function
Croatian: Hepatitis, abnormalna funkcija jetre
English: It is important that you continue to take Sabervel until your doctor tells you otherwise.
Croatian: Važno je da kontinuirano uzimate Sabervel sve dok Vam liječnik ne kaže drukčije.
English: Other medicines and Sabervel
Croatian: Drugih lijekova i Sabervel
English: Important information about some of the ingredients of Sabervel Sabervel contains lactose.
Croatian: Važne informacije o nekim sastojcima Sabervela Sabervel sadrži laktozu.
English: Irbesartan did not affect survival, development, or reproduction of offspring.
Croatian: Irbesartan nije imao učinka na preživljenje, razvoj, ili reprodukcijsku sposobnost potomstva.
English: WHAT SABERVEL IS AND WHAT IT IS USED FOR
Croatian: ŠTO JE SABERVEL I ZA ŠTO SE KORISTI
English: Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
Croatian: Vezivanje za proteine plazme iznosi oko 96%, s neznatnim vezanjem za krvne stanice.
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation is in place and functioning before and whilst the medicinal product is on the market.
Croatian: Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav prikazan u Modulu 1.8.1. nositelja odobrenja, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
English: Such conditions should be corrected before the administration of Sabervel.
Croatian: Takva stanja treba korigirati prije primjene Sabervela.
English: No specific information is available on the treatment of overdose with Sabervel.
Croatian: Nema dostupnih specifičnih podataka o liječenju predoziranja Sabervelom.
English: • if you are allergic (hypersensitive) to irbesartan or any other ingredients of Sabervel
Croatian: • Ako ste alergični (preosjetljivi) na irbesartan ili neki drugi sastojak Sabervela.
English: Your doctor will normally advise you to stop taking Sabervel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Sabervel.
Croatian: Vaš će Vam liječnik obično preporučiti da prestanete uzimati Sabervel prije nego što zatrudnite ili čim saznate da ste trudni te će Vam savjetovati da uzmete neki drugi lijek umjesto Sabervela.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Croatian: Detaljne informacije o ovog lijeka dostupne su na web stranici Europske agencije za lijekove (EMAe): http://www.ema.europa.eu/.
English: Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 4.8, 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
English: (See section 5.3).
Croatian: (vidjeti dio 5.1.).
English: Warnings and precautions Tell your doctor if any of the following apply to you:
Croatian: Upozorenja i mjere opreza Obavijestite svog liječnika ako se nešto od dolje navedenog odnosi na Vas:
English: After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Croatian: Nakon peroralne primjene irbesartan se dobro apsorbirao: ispitivanja apsolutne bioraspoloživosti pokazala su vrijednosti oko 60-80%.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Croatian: Epidemiološki dokazi koji se odnose na rizik od teratogenog učinka nakon uporabe ACE inhibitora tijekom prvog tromjesečja nisu bili dostatni za donošenje zaključaka; manji porast rizika, međutim, ne može se isključiti.
English: Sabervel is unlikely to affect your ability to drive or use machines.
Croatian: Sabervel ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: • The active substance is irbesartan.
Croatian: Djelatna tvar je irbesartan.
English: Less than 2% of the dose is excreted in the urine as unchanged irbesartan.
Croatian: Manje od 2% doze izlučuje se u obliku nepromijenjenog irbesartana.
English: Lactose: this medicinal product contains lactose.
Croatian: Laktoza: ovaj lijek sadrži laktozu.
English: • potassium-sparing medicines (such as certain diuretics)
Croatian: • lijekove koji čuvaju kalij (kao što su neki diuretici)
English: Tell your doctor if any of the following apply to you:
Croatian: Obavijestite svog liječnika ako se nešto od dolje navedenog odnosi na Vas:
English: Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18 - 40
Croatian: Vrijednosti AUC i Cmax irbesartana također su bile nešto veće u starijih ispitanika (≥ 65 godina) u usporedbi s mlađima (18-40 godina).
English: Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Croatian: Stariji: iako za bolesnike starije od 75 godina treba razmotriti započinjanje terapije dozom od 75 mg, prilagodba doze obično nije potrebna.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove (EMA) http://www.ema.europa.eu/
English: Use in Children
Croatian: Primjena kod djece
English: orthostatic hypotension*
Croatian: ortostatska hipotenzija*
English: Read all of this leaflet carefully before you start taking this medicine .
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati lijek.
English: Therefore, the use of Sabervel is not recommended.
Croatian: Stoga se ne preporučuje primjena Sabervela.
English: The PSUR submission schedule should follow the PSUR submission schedule for the reference medicinal product.
Croatian: Plan predavanja PSUR-a treba slijediti raspored prijave PSUR-a za referentni lijek.
English: arthralgia, myalgia (in some cases associated with increased plasma creatine kinase
Croatian: Artralgija, mijalgija (u nekim slučajevima povezana s povećanom koncentracijom kreatin kinaze u plazmi), grčevi mišića
English: The frequency of adverse reactions listed below is defined using the following convention:
Croatian: Učestalost dolje navedenih nuspojava definirana je na sljedeći način:
English: Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e.g.,
Croatian: Bolesnici u svim liječenim skupinama obično su uzimali između 2 i 4 antihipertenzivna lijeka (npr.
English: Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Croatian: Rodopi Prefecture, Block No 5, Rodopi 69300, Grčka
English: Cartons of 28, 56, 90 or 98 film-coated tablets in PVC/PVDC-aluminium/PVDC blisters.
Croatian: Kutije s 28, 56, 90 ili 98 filmom obloženih tableta u PVC/PVDC-aluminij/PVDC blisterima.
English: Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Croatian: Primarni aldosteronizam: bolesnici s primarnim hiperaldosteronizmom općenito ne reagiraju na antihipertenzivne lijekove koji djeluju putem inhibicije renin-angiotenzinskog sustava.
English: No significant effects on the number of corpora lutea, implants, or live fetuses were observed.
Croatian: Nisu zabilježeni značajni učinci na broj žutih tijela, implantate, ili žive fetuse.
English: C.V. MEDILINE LTD
Croatian: MEDILINE LTD
English: See also information under the heading “Do not take Sabervel”.
Croatian: Vidjeti također informacije pod naslovom “Nemojte <uzimati> <primjenjivati> Saberver”
English: C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Croatian: C irbesartana, 80-85% cirkulirajuće radioaktivnosti u plazmi odnosi se na nepromijenjeni irbesartan.
English: Pharmathen International S.A. Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300,
Croatian: Pharmathen International S.A. Industrijski Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300,
English: Mechanism of action: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Croatian: Mehanizam djelovanja: irbesartan je snažan, oralno djelotvoran, selektivni antagonist receptora angiotenzina II (tip AT1).
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet gotovog lijeka:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kutija
English: This leaflet was last approved in
Croatian: Uputa je zadnji puta odobrena u {MM/GGGG}.
English: Keep out of the sight and reach of children.
Croatian: Čuvati izvan dohvata i pogleda djece.