FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, during treatment with the veterinary medicinal product, other products that can inhibit pglycoprotein (e.g. cyclosporine, ketoconazole, spinosad, verapamil) should only be used concomitantly according to the benefit-risk assessment of the responsible veterinarian.
Croatian: Stoga se tijekom liječenja ovim veterinarsko-medicinskim proizvodom ostali proizvodi koji mogu inhibirati p-glikoprotein (npr. ciklosporin, ketokonazol, spinozad, verapamil) mogu se istodobno primjenjivati samo u skladu s procjenom koristi i rizika od strane nadležnog veterinara.
English: In endemic areas, dogs should receive lungworm and/or heartworm preventive treatments at monthly intervals.
Croatian: U endemičnim područjima psi trebaju primati preventivne tretmane protiv plućnih vlasaca i/ili srčanih crva u mjesečnim intervalima.
English: This interference leads to the opening of the chloride channels on the postsynaptic junction to allow the inflow of chloride ions.
Croatian: Ova interferencija dovodi do otvaranja kloridnih kanala na postsinaptičkom spoju kako bi se omogućio ulazak kloridnih iona.
English: However, accidental administration to dogs infected with adult heartworms should not pose safety concerns.
Croatian: Međutim, slučajna primjena na psima infestiranima odraslim srčanim crvima ne ugrožava sigurnost pasa.
English: Simparica Trio chewable tablets sarolaner (mg)
Croatian: Simparica Trio tablete za žvakanje sarolaner (mg)
English: Tablet is debossed with the sarolaner strength on one face of the tablet.
Croatian: Tableta ima oznaku jačine sarolanera s jedne strane.
English: A single treatment is efficacious for the treatment of gastrointestinal nematodes.
Croatian: Jednokratan tretman učinkovit je za liječenje infestacije gastrointestinalnim nematodima.
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
Croatian: U slučaju nehotičnog gutanja, odmah potražite savjet liječnika i pokažite mu uputu o veterinarsko-medicinskom proizvodu ili etiketu.
English: In particular, both active substances contribute to the overall efficacy against the gastrointestinal nematodes Ancylostoma caninum and Toxocara canis.
Croatian: Točnije, obje djelatne tvari doprinose sveukupnoj učinkovitosti protiv gastrointestinalnih nematoda Ancylostoma caninum i Toxocara canis.
English: The prandial state of the dogs does not affect the extent of absorption of sarolaner and moxidectin.
Croatian: Prandijalni status pasa ne utječe na stupanj apsorpcije sarolanera i moksidektina.
English: To prevent children from accessing the product, only one chewable tablet at a time should be removed from the blister pack and only when required.
Croatian: Kako djeca ne bi imala pristup proizvodu, iz blistera vadite samo jednu po jednu tabletu za žvakanje i samo kada je to potrebno.
English: Pyrantel is a nicotinic acetylcholine (ACh) channel receptor (nAChR) agonist.
Croatian: Pirantel je agonist nikotinskih acetilkolinskih (ACh) kanalskih receptora (nAChR).
English: A single administration also prevents lungworm disease (by reducing the immature adults (L5) of A. vasorum) and heartworm disease (D. immitis) for one month.
Croatian: Jednokratna primjena također sprečava infestaciju s plućnim vlascima (smanjujući broj nezrelih odraslih (L5) jedinki A. vasorum) i bolest srčanog crva (D. immitis) tijekom jednog mjeseca.
English: In the absence of the risk of mixed co-infestation, a narrower spectrum parasiticide should be used.
Croatian: Ako ne postoji rizik od mješovitih istodobnih infestacija, potrebno je koristiti paraziticid užeg spektra.
English: Dogs in areas endemic for heartworm (or those which have travelled to endemic areas) may be infected with adult heartworms.
Croatian: Psi u područjima endemičnim za srčane crve (ili psi koji su putovali u endemična područja) mogu biti infestirani odraslim srčanim crvima.
English: The veterinary medicinal product kills newly emerged fleas on the dog before they can lay eggs and therefore it prevents environmental flea contamination in areas to which the dog has access.
Croatian: Ovaj veterinarsko-medicinski proizvod ubija nove buhe na psu prije nego što uspiju izleći jajašca i tako sprečava kontaminaciju okoline buhama u područjima kojima pas ima pristup.
English: This results in flaccid paralysis and eventual death of parasites exposed to the drug.
Croatian: To rezultira flacidnom paralizom, a s vremenom i smrću parazita izloženih lijeku.
English: Sarolaner is an acaricide and insecticide belonging to the isoxazoline family.
Croatian: Sarolaner je akaricid i insekticid iz skupine izoksazolina.
English: A reddish-brown colored, pentagon shaped tablet with rounded edges.
Croatian: Crvenkasto-smeđa obojena tableta oblika peterokuta sa zaobljenim rubovima.
English: − For the prevention of heartworm disease (Dirofilaria immitis);
Croatian: Za prevenciju bolesti srčanog crva (Dirofilaria immitis);
English: Ticks on the animal prior to administration or from new infestations after product administration are killed within 48 hours.
Croatian: Krpelji na životinji prije primjene ili pri novim infestacijama nakon primjene proizvoda ugibaju u roku od 48 sati.
English: The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for 5 weeks;
Croatian: Veterinarsko medicinski proizvod ima trenutačan i postojan učinak ubijanja buha protiv novih infestacija tijekom 5 tjedna;
English: After treatment of the nematode infections, further flea and tick treatment should be continued with a mono-active product.
Croatian: Nakon liječenja infekcija nematodima, daljnje tretiranje protiv buha i krpelja potrebno je nastaviti proizvodom s jednom djelatnom tvari.
English: EU/2/19/243/001-018
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/19/243/001-018
English: After a single administration of 5 times the maximum recommended dose to this sensitive dog breed, transient ataxia and/or muscle fasciculation were observed.
Croatian: Nakon jednokratne primjene doze do 5 puta veće od maksimalne preporučene doze za ovu osjetljivu pasminu pasa, primijećene su prolazna ataksija i/ili mišićna fascikulacija.
English: Sarolaner exhibits higher functional potency to block insect/acarine receptors compared to mammalian receptors.
Croatian: Sarolaner iskazuje veću funkcionalnu snagu blokiranja receptora insekata/akarina u usporedbi s receptorima sisavaca.
English: If based on veterinarian opinion re-administration(s) of the product is required, any subsequent administration(s) must follow the minimum 1-month interval schedule.
Croatian: Ako je prema mišljenju veterinara potrebna ponovna primjena proizvoda, sve sljedeće primjene moraju slijediti raspored s minimalnim intervalom od 1 mjeseca.
English: Following receptor binding, the channel opens to allow the influx of cations resulting in a depolarization and excitatory effects on nematode muscle, ultimately leading to spastic paralysis of the worm and death.
Croatian: Nakon vezanja na receptore, kanal se otvara i omogućuje ulazak kationa, što rezultira depolarizacijom i ekscitatornim učincima na mišiće nematoda te u konačnici dovodi do spastičke paralize crva i njegove smrti.
English: The product was well tolerated in dogs with a deficient multidrug-resistance-protein 1 (MDR1 -/-).
Croatian: Proizvod dobro podnose psi s nedostatkom proteina 1 višestruke rezistencije na lijekove (MDR1 -/-).
English: Colorants: Sunset Yellow FCF (E110), Allura Red (E129), Indigo Carmine (E132).
Croatian: Bojila: Sunset žuto FCF (E110), Allura crveno (E129), Indigotin (E132).
English: Corden Pharma GmbH Otto-Hahn-Str., Plankstadt Baden-Wuerttemberg
Croatian: Otto-Hahn-Str., Plankstadt Baden-Wuerttemberg
English: Sarolaner does not interact with known insecticidal binding sites of nicotinic or other GABAergic insecticides such as neonicotinoids, fiproles, milbemycins, avermectins, and cyclodienes.
Croatian: Sarolaner nema interakciju s poznatim mjestima vezanja insekticida nikotinskih ili drugih GABA-ergičkih insekticida kao što su neonikotinoidi, fiproli, milbemicini, avermektini i ciklodieni.
English: Parasite resistance to any particular class of parasiticides may develop following the frequent, repeated use of a product of that class.
Croatian: Paraziti mogu razviti rezistenciju na određenu skupinu paraziticida u slučaju učestale i višekratne upotrebe proizvoda iz te klase.
English: Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Croatian: Ne primjenjivati u slučajevima preosjetljivosti na djelatne tvari ili neku od pomoćnih tvari.
English: − For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis).
Croatian: Za liječenje infestacije buhama (Ctenocephalides felis i Ctenocephalides canis).
English: Simparica Trio tablets are palatable and readily consumed by the majority of dogs when offered by the owner.
Croatian: Trio tablete su ugodnog okusa i većina pasa ih bez oklijevanja uzima od vlasnika.
English: The veterinary medicinal product should be administered at a dose of 1.2-2.4 mg/kg of sarolaner, 0.024-0.048 mg/kg of moxidectin and 5-10 mg/kg of pyrantel in accordance with the following table:
Croatian: Veterinarsko-medicinski proizvod potrebno je primijeniti u dozi od 1,2-2,4 mg/kg sarolanera, 0,0240,048 mg/kg moksidektina i 5-10 mg/kg pirantela, prema sljedećoj tablici:
English: In a laboratory study, the product was well tolerated in dogs with a deficient multidrug-resistanceprotein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose.
Croatian: U laboratorijskim istraživanjima, proizvod je imao dobru podnošljivost u pasa s nedostatkom proteina-1 (MDR-1 -/-), nakon jedne oralne primjene 3 puta veće doze od preporučene.
English: The primary target of action of sarolaner in insects and acarines is functional blockade of ligand-gated chloride channels (GABA-receptors and glutamate-receptors).
Croatian: Primarni cilj djelovanja sarolanera na insekte i akaricide je funkcionalna blokada ligandom reguliranih kloridnih kanala (GABA receptori i receptori glutamata).
English: Sarolaner is readily and rapidly absorbed systemically following oral dosing, reaching maximum concentrations in plasma within 3.5 hours (tmax) after administration with a high bioavailability of 86.7%.
Croatian: Sarolaner se lako i brzo sustavno apsorbira nakon oralne primjene te postiže maksimalne koncentracije u plazmi unutar 3,5 sati (tmax) nakon primjene, uz visoku bioraspoloživost od 86,7%.
English: Pyrantel mimics the agonist effects of ACh through high affinity binding to subtype specific ionophoric nAChRs in nematodes, while not binding at muscarinic mAChRs.
Croatian: Pirantel oponaša agonističke učinke ACh-a tako što se s visokim afinitetom veže na podtip specifičnih ionofornih nAChR-a kod nematoda, ali se ne veže na muskarinske mAChR-e.
English: Ticks and fleas need to start feeding on the host to become exposed to sarolaner; therefore, the transmission of infectious parasite-borne diseases cannot be excluded.
Croatian: Da bi postali izloženi sarolaneru, krpelji i buhe moraju se početi hraniti krvlju domaćina, stoga se ne može isključiti prijenos infektivnih bolesti koje paraziti prenose.
English: The veterinary medicinal product also provides concurrent efficacy for the prevention of heartworm disease and angiostrongylosis.
Croatian: Ovaj veterinarsko-medicinski proizvod također pruža istovremenu učinkovitost za prevenciju bolesti srčanog crva i angiostrongiloze.
English: Pyrantel is active against immature stages (L5) and adults of Toxocara canis, adults of Ancylostoma caninum, Toxascaris leonina and Uncinaria stenocephala.
Croatian: Pirantel djeluje protiv nezrelih stadija (L5) i odraslih Toxocara canis, odraslih Ancylostoma caninum, Toxascaris leonina i Uncinaria stenocephala.
English: The veterinary medicinal product can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a mono-active flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infections.
Croatian: Veterinarsko-medicinski proizvod može se koristiti kao dio sezonskog tretiranja buha i krpelja (kao zamjena za tretiranje proizvodima protiv buha i krpelja s jednom djelatnom tvari) u pasa s dijagnosticiranim istodobnim infestacijama gastrointestinalnim nematodima.
English: Moxidectin is readily and rapidly absorbed systemically following oral dosing, reaching maximum concentrations in plasma within 2.4 hours (tmax) after administration and with 66.9% bioavailability.
Croatian: Moksidektin se lako i brzo sustavno apsorbira nakon oralne primjene te postiže maksimalne koncentracije u plazmi unutar 2,4 sati (tmax) nakon primjene, uz bioraspoloživost od 66,9%.
English: moxidectin (mg)
Croatian: moksidektin (mg)
English: Sarolaner is slowly eliminated from plasma (half-life of approximately 12 days) via biliary excretion and elimination through the faeces with minor contributions of metabolic clearance.
Croatian: Sarolaner se sporo eliminira iz plazme (poluvijek od približno 12 sati) putem bilijarnog izlučivanja i eliminacije kroz feces, uz manje doprinose metaboličkog klirensa.
English: The product should only be used in dogs when treatment of ticks / fleas and gastrointestinal nematodes is indicated at the same time.
Croatian: Proizvod je potrebno primjenjivati u pasa samo kada je istovremeno indicirano liječenje krpelja/buha i gastrointestinalnih nematoda.
English: Sarolaner binding to these receptors prevents the uptake of chloride ions by GABA and glutamate gated ion channels, thus resulting in increased nerve stimulation and death of the target parasite.
Croatian: Sarolaner koji se veže na ove receptore sprečava pohranu kloridnih iona putem ionskih kanala reguliranih GABA-om i glutamatom, što rezultira povećanom stimulacijom živaca i smrću ciljniog parazita.
English: Moxidectin is slowly eliminated from plasma (half-life of approximately 11 days) via biliary excretion and elimination through the faeces with minor contributions of metabolic clearance.
Croatian: Moksidektin se sporo eliminira iz plazme (poluvijek od približno 11 dana) putem bilijarnog izlučivanja i eliminacije kroz feces, uz manje doprinose metaboličkog klirensa.
English: Its principal mode of action is interfering with neuromuscular transmission at the level of the glutamate-gated chloride channels and, to a lesser extent, of GABA (gamma amino butyric acid)-gated channels.
Croatian: Njegov glavni način djelovanja je ometanje neuromuskularnog prijenosa na razini glutamatom reguliranih kloridnih kanala te, u manjoj mjeri, GABA-om (gama-aminomaslačna kiselina) reguliranih kanala.
English: Prevention of heartworm disease and angiostrongylosis:
Croatian: Prevencija bolesti srčanog crva i angiostrongiloze:
English: Sarolaner blocks GABA- and glutamate-gated chloride channels in the central nervous system of insects and acarines.
Croatian: Sarolaner blokira GABA-om i glutamatom regulirane kloridne kanale u središnjem živčanom sustavu insekata i akarina.
English: − For the treatment of tick infestations.
Croatian: Za liječenje infestacija krpeljima.
English: The veterinary medicinal product is exclusively indicated when use against ticks or fleas and gastrointestinal nematodes is indicated at the same time.
Croatian: Ovaj veterinarsko-medicinski proizvod indiciran je isključivo kada je istovremeno indicirana primjena protiv krpelja ili buha i gastrointestinalnih nematoda.
English: − For the prevention of angiostrongylosis by reducing the level of infection with immature adult
Croatian: Za prevenciju angiostrongiloze smanjenjem razine infekcije nezrelim adultnim (L5) stadijima
English: Treatment of flea and tick infestations and gastrointestinal nematodes:
Croatian: Liječenje infestacija buhama i krpeljima i gastrointestinalnim nematodima:
English: 3 mg/0.06 mg/12.5 mg 6 mg/0.12 mg/25 mg 12 mg/0.24 mg/50 mg 24 mg/0.48 mg/100 mg 48 mg/0.96 mg/200 mg 72 mg/1.44 mg/300 mg sarolaner/moxidectin/pyrantel (EN or Latin)
Croatian: 3 mg/0,06 mg/12,5 mg 6 mg/0,12 mg/25 mg 12 mg/0,24 mg/50 mg 24 mg/0,48 mg/100 mg 48 mg/0,96 mg/200 mg 72 mg/1,44 mg/300 mg sarolaner/moksidektin/pirantel (EN ili Latinski)
English: The veterinary medicinal product has immediate and persistent tick killing activity for 5 weeks against Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus and for 4 weeks against Dermacentor reticulatus;
Croatian: Veterinarsko-medicinski proizvod ima trenutačan i postojan učinak ubijanja krpelja tijekom 5 tjedana protiv Ixodes hexagonus, Ixodes ricinus i
English: sarolaner 3 mg/moxidectin 0.06 mg/pyrantel (as embonate) 12.5 mg sarolaner 6 mg/moxidectin 0.12 mg/pyrantel (as embonate) 25 mg sarolaner 12 mg/moxidectin 0.24 mg/pyrantel (as embonate) 50 mg sarolaner 24 mg/moxidectin 0.48 mg/pyrantel (as embonate) 100 mg sarolaner 48 mg/moxidectin 0.96 mg/pyrantel (as embonate) 200 mg sarolaner 72 mg/moxidectin 1.44 mg/pyrantel (as embonate) 300 mg
Croatian: sarolaner 3 mg/moksidektin 0,06 mg/pirantel (kao embonat) 12,5 mg sarolaner 6 mg/moksidektin 0,12 mg/pirantel (kao embonat) 25 mg sarolaner 12 mg/moksidektin 0,24 mg/pirantel (kao embonat) 50 mg sarolaner 24 mg/moksidektin 0,48 mg/pirantel (kao embonat) 100 mg sarolaner 48 mg/moksidektin 0,96 mg/pirantel (kao embonat) 200 mg sarolaner 72 mg/moksidektin 1,44 mg/pirantel (kao embonat) 300 mg
English: Fleas on the animal prior to administration are killed within 8 hours.
Croatian: Buhe na životinji prisutne prije primjene ugibaju u roku od 8 sati.
English: Calcium hydrogen phosphate anhydrous
Croatian: Kalcijev hidrogenfosfat, bezvodni
English: − Toxocara canis immature adults (L5) and adults;
Croatian: − nezreli odrasli oblici (L5) i adulti Toxocara canis;
English: (L5) stages of Angiostrongylus vasorum.
Croatian: L4 stadija Dirofilaria immitis i nezrelih stadija (L5) Angiostrongylus vasorum.
English: Simparica Trio 1.25-2.5 kg Simparica Trio >2.5-5 kg Simparica Trio >5-10 kg Simparica Trio >10-20 kg Simparica Trio >20-40 kg Simparica Trio >40-60 kg
Croatian: Simparica Trio >2,5-5 kg Simparica Trio >5-10 kg Simparica Trio >10-20 kg Simparica Trio >20-40 kg Simparica Trio >40-60 kg
English: Tablet strength 72 mg/1.44 mg/300 mg
Croatian: 72 mg/1,44 mg/300 mg
English: Wheat germ
Croatian: Pšenične klice
English: Hydrolysed vegetable protein Gelatin
Croatian: Svinjska jetra u prahu Hidrolizirani biljni protein Želatina
English: For the treatment of gastrointestinal roundworm and hookworm infections:
Croatian: Za liječenje gastrointestinalnih infekcija oblićima i kukastim crvima:
English: Other nematodes
Croatian: Drugi nematodi
English: Confectioner's sugar Glucose, liquid
Croatian: Glukoza, tekuća
English: Each tablet contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži:
English: Tablet strength 48 mg/0.96 mg/200 mg
Croatian: 48 mg/0,96 mg/200 mg
English: Butylhydroxytoluene (E321) Pigment blend 018 (E110, E129, E132) Hydroxypropylcellulose Silica, colloidal anhydrous Magnesium stearate Maize starch
Croatian: Butilhidroksitoluen (E321) Mješavina pigmenta 018 (E110, E129, E132)
English: Tablet strength 24 mg/0.48 mg/100 mg
Croatian: 24 mg/0,48 mg/100 mg
English: Ectoparasites
Croatian: Simparica
English: − Ancylostoma caninum L4 larvae, immature adults (L5) and adults;
Croatian: − L4 larve, nezreli odrasli oblici (L5) i adulti Ancylostoma caninum;
English: Pork liver powder
Croatian: Šećer u prahu
English: for dogs 1.25-2.5 kg for dogs >2.5-5 kg for dogs >5-10 kg for dogs >10-20 kg for dogs >20-40 kg for dogs >40-60 kg
Croatian: za pse 1,25-2,5 kg za pse >2,5-5 kg za pse >5-10 kg za pse >10-20 kg za pse >20-40 kg za pse >40-60 kg
English: Sarolaner is active against adult fleas (Ctenocephalides felis and Ctenocephalides canis) as well as several tick species such as Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus.
Croatian: Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus i Rhipicephalus sanguineus.
English: Tablet strength 3 mg/0.06 mg/ 12.5 mg
Croatian: Jačina tablete 3 mg/0,06 m g/12,5 mg
English: Moxidectin is active against adults of Toxocara canis, L4 larvae and immature stages (L5) of Ancylostoma caninum, L4 of Dirofilaria immitis and immature stages (L5) of Angiostrongylus vasorum.
Croatian: Moksidektin djeluje protiv odraslih jedinki Toxocara canis, L4 larvi i nezrelih stadija (L5)
English: chewable tablet
Croatian: OBLIK tableta za žvakanje
English: Lactose monohydrate Sodium starch glycolate type A Meglumine
Croatian: Natrijev škrobni glikolat tipa
English: Tablet strength 12 mg/0.24 mg/50 mg
Croatian: 12 mg/0,24 mg/50 mg
English: Tablet strength 6 mg/0.12 mg/25 mg
Croatian: Jačina tablete 6 mg/0,12 m g/25 mg
English: Tablet strength 3 mg/0.06 mg/12.5 mg
Croatian: 3 mg/0,06 m g/12,5 mg
English: Manufacturer responsible for batch release: Corden Pharma GmbH Otto-Hahn-Str., Plankstadt 68723 Baden-Wuerttemberg GERMANY
Croatian: 68723 Baden-Wuerttemberg
English: PACKAGE LEAFLET: Simparica Trio chewable tablets for dogs 1.25-2.5 kg Simparica Trio chewable tablets for dogs >2.5-5 kg Simparica Trio chewable tablets for dogs >5-10 kg Simparica Trio chewable tablets for dogs >10-20 kg Simparica Trio chewable tablets for dogs >20-40 kg Simparica Trio chewable tablets for dogs >40-60 kg
Croatian: UPUTA O VMP ZA: Simparica Trio tablete za žvakanje za pse od 1,25-2,5 kg Simparica
English: Use at the same time each day.
Croatian: Primijenite svaki dan u isto vrijeme.
English: Tilt your head back.
Croatian: Zabacite glavu prema natrag.
English: Carton containing 1 or 3 bottles.
Croatian: Kutija sadrži 1 ili 3 boce.
English: Plasma concentrations are very low.
Croatian: Koncentracije u plazmi su vrlo niske.
English: All subjects were reported to have made a full recovery, usually within 6-24 hours.
Croatian: Kod svih bolesnika došlo je do potpunog oporavka, obično unutar 6-24 sata.
English: Continue with the next dose as planned.
Croatian: Nastavite sa slijedećom dozom kako je planirano.
English: There are no efficacy and safety data for adjunct therapy beyond 6 weeks.
Croatian: Nema podataka o djelotvornosti i sigurnosti dodatne terapije nakon 6 tjedana.
English: Do not touch the dropper with your fingers when opening or closing the bottle.
Croatian: Ne dodirujte kapaljku sa prstima kada otvarate ili zatvarate bocu.
English: Contact with soft contact lenses should be avoided.
Croatian: Kontakt s mekim kontaktnim lećama se mora izbjegavati.
English: Date of first authorisation: 18 July 2014 Date of last renewal: 20 February 2019
Croatian: Datum posljednje obnove odobrenja: 20. veljače 2019.
English: Hold the bottle, pointing down, between your thumb and fingers.
Croatian: Držite bocu, okrenutu prema dolje, između palca i ostalih prstiju.
English: The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years have not been established.
Croatian: Sigurnost i djelotvornost SIMBRINZE u djece i adolescenata u dobi od 2 do 17 godina nisu ustanovljene.
English: Wash your hands before you start.
Croatian: Operite ruke prije primjene.
English: Do not put in any more drops until it is time for your next regular dose.
Croatian: Ne ukapavajte dalje kapi sve dok ne dođe vrijeme za slijedeću uobičajenu dozu.
English: The drop will go in here (picture 1).
Croatian: . Tu se nanosi kap (slika 1).
English: If you use drops in both eyes, repeat the steps for your other eye.
Croatian: Ako primjenjujete kapi na oba oka, ponovite korake za dugo oko.
English: Do not drive or use machines until the symptoms are cleared.
Croatian: Nemojte upravljati vozilima ni strojevima sve dok Vam se ovi simptomi ne povuku.
English: Only use SIMBRINZA for your eyes.
Croatian: SIMBRINZU primjenjujte samo za oči.
English: BE-2870 Puurs Belgium or
Croatian: BE-2870 Puurs Belgija ili
English: Do not swallow or inject.
Croatian: Nemojte gutati niti injicirati.
English: White-to-off-white uniform suspension, pH 6.5 (approximately).
Croatian: Bijela do bjelkasta jednolična suspenzija, pH 6,5 (približno).
English: In rabbits, maximum ocular concentrations were achieved in less than one hour in most cases.
Croatian: Kod kunića, maksimalne koncentracije u oku postignute su za manje od jednog sata u većini slučajeva.