FrancophonIA/ELRC3.0 huggingface dataset:
English: Rhokiinsa, which has a different mode of action from previously authorised treatments, provides another treatment option for patients with open-angle glaucoma and ocular hypertension.
Croatian: Lijek Rhokiinsa, koji ima drugačiji način djelovanja od prethodno odobrenih lijekova, predstavlja dodatnu mogućnost liječenja za bolesnike s glaukomom otvorenog kuta i očnom hipertenzijom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rhokiinsa have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Rhokiinsa nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Other information about Rhokiinsa
Croatian: Ostale informacije o lijeku Rhokiinsa
English: Other common side effects (which may affect up to 2 in 10 people) are: cornea verticillata (deposits in the cornea, the transparent layer in front of the eye that covers the pupil and iris), eye pain, conjunctival haemorrhage (bleeding in the surface layer of the eye), erythema (reddening) at the site where the medicine was applied and the eyelid, corneal staining, blurred vision and increased lacrimation (watery eyes).
Croatian: Ostale česte nuspojave (koje se mogu javiti u do 2 na 10 osoba) jesu: cornea verticillata (naslage u rožnici, prozirnom sloju u prednjem dijelu oka koji pokriva zjenicu i šarenicu), bol u oku, konjuktivno krvarenje (krvarenje u površinskom sloju oka), eritem (crvenilo) na mjestu primjene lijeka i na očnom kapku, obojanost rožnice, zamućen vid i povećana lakrimacija (suzne oči).
English: For more information about using Rhokiinsa, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Rhokiinsa pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: This means that it blocks the activity of an enzyme called Rho kinase, which has a role in controlling drainage of fluid from the eye.
Croatian: To znači da inhibira djelovanje enzima Rho kinaze koji kontrolira istjecanje tekućine iz oka.
English: As for all medicines, data on the use of Rhokiinsa are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Rhokiinsa kontinuirano se prate.
English: An overview of Rhokiinsa and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Rhokiinsa i zašto je odobren u EU-u
English: Why is Rhokiinsa authorised in the EU?
Croatian: Zašto je lijek Rhokiinsa odobren u EU-u?
English: Rhokiinsa is an eye-drop solution that is used to reduce pressure inside the eye in adults who have open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal).
Croatian: Rhokiinsa je otopina kapi za oči koja se koristi za smanjenje očnog tlaka u odraslih koji imaju glaukom otvorenog kuta (bolest kod koje tlak u oku raste zbog nemogućnosti istjecanja tekućine iz oka) ili očnu hipertenziju (kada je tlak u oku viši od normalnog).
English: The active substance in Rhokiinsa, netarsudil, is a Rho kinase inhibitor.
Croatian: Djelatna tvar u lijeku Rhokiinsa, netarsudil, inhibitor je Rho kinaze.
English: The most common side effect with Rhokiinsa (which may affect around 5 in 10 people) is conjunctival hyperaemia (increased blood supply to the eye, leading to redness).
Croatian: Najčešća nuspojava lijeka Rhokiinsa (koja se može javiti u otprilike 5 na 10 osoba) je konjuktivna hiperemija (povišen dotok krvi u oko što uzrokuje crvenilo).
English: A main study of 708 patients with open-angle glaucoma or ocular hypertension showed that Rhokiinsa is effective at lowering eye pressure.
Croatian: U glavnom ispitivanju na 708 bolesnika s glaukomom otvorenog kuta ili očnom hipertenzijom utvrđeno je da je lijek Rhokiinsa djelotvoran u snižavanju očnog tlaka.
English: In patients whose eye pressure was higher than 25 mmHg, Rhokiinsa was less effective than timolol.
Croatian: U bolesnika čiji je očni tlak bio veći od 25 mmHg, lijek Rhokiinsa bio je manje djelotvoran od timolola.
English: What are the risks associated with Rhokiinsa?
Croatian: Koji su rizici povezani s lijekom Rhokiinsa?
English: Rhokiinsa contains the active substance netarsudil.
Croatian: Lijek Rhokiinsa sadrži djelatnu tvar netarsudil.
English: The effect of Rhokiinsa was less pronounced in patients whose eye pressure was more than 30 mmHg, but these results were considered less important because Rhokiinsa is not expected to be used on its own in this group.
Croatian: Njegovo je djelovanje bilo manje naglašeno u bolesnika čiji je očni tlak iznosio preko 30 mmHg, ali ti su se podatci smatrali manje važnima jer se ne očekuje da će se lijek Rhokiinsa za tu skupinu bolesnika primjenjivati kao monoterapija.
English: In terms of safety, the side effects of Rhokiinsa are considered manageable and were more likely to be confined to the eye.
Croatian: Kada je riječ o sigurnosti, smatra se da je nuspojave lijeka Rhokiinsa moguće kontrolirati te da su vrlo vjerojatno ograničene na oko.
English: Rhokiinsa showed good effects across a range of eye pressures.
Croatian: Lijek Rhokiinsa pokazao se kao djelotvoran za različite vrste očnih tlakova.
English: Rhokiinsa is only available on prescription and should be started by an eye specialist.
Croatian: Lijek Rhokiinsa izdaje se samo na recept, a liječenje treba započeti specijalist oftalmolog.
English: How does Rhokiinsa work?
Croatian: Kako djeluje Rhokiinsa?
English: What benefits of Rhokiinsa have been shown in studies?
Croatian: Koje su koristi od lijeka Rhokiinsa utvrđene u ispitivanjima?
English: When it blocks this enzyme, Rhokiinsa increases the flow of fluid out of the eyeball, thereby lowering pressure inside the eye. Rhokiinsa is also thought to lower eye pressure by reducing pressure in the veins around the eyes.
Croatian: Kada lijek Rhokiinsa taj enzim ihhibira, povećava se istjecanje tekućine iz očne jabučice i time se smanjuje očni tlak.
English: For the full list of side effects and restrictions with Rhokiinsa, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Rhokiinsa potražite u uputi o lijeku.
English: How is Rhokiinsa used?
Croatian: Kako se Rhokiinsa primjenjuje?
English: Packaging Content Package size
Croatian: Put primjene Pakiranje Sadržaj Veličina pakiranja
English: ATCvet code: QI06AJ03.
Croatian: ATCvet kod: QI06AJ03.
English: Date of first authorisation: 23/02/2005 Date of last renewal: 14/01/2010
Croatian: Datum prvog odobrenja: 23/02/2005 Datum posljednje obnove: 14/01/2010
English: Primary vaccination course: - first injection: from 8 weeks of age, - second injection: 3 to 4 weeks later.
Croatian: Prvo cijepljenje: - prva injekcija: od 8 tjedana starosti, - druga injekcija: 3 do 4 tjedna kasnije.
English: * less than 1 animal in 10,000 animals displaying adverse reaction(s) during the course of one treatment, including isolated reports.
Croatian: * manje od 1 životinje na 10.000 životinja pokazalo je nuspojave tijekom jedne primjene, uključujući izolirane slučajeve
English: EU/2/04/050/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/050/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Croatian: EU/2/04/050/001 Liofilizat (10 bočica s 1 dozom) + otapalo (10 bočica od 1 ml) EU/2/04/050/002 Liofilizat (50 bočica s 1 dozom) + otapalo (50 bočica od 1 ml)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja)
English: A local reaction may occur (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most.
Croatian: Može se javiti i lokalna reakcija (lagana bol pri palpaciji, svrbež ili ograničena otok) koja nestaje za najviše 1 ili 2 tjedna.
English: Manufacturer responsible for the batch release: MERIAL
Croatian: Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet: MERIAL
English: Where high levels of maternal antibodies against rhinotracheitis, calicivirosis, panleucopenia or Chlamydophila components are expected to be present (e.g. in kittens of 9-12 weeks of age borne from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Croatian: kaliciviroze, panleukopenije ili Chlamydophila (npr. kod mačića u dobi 9-12 tjedana porijeklom od mačaka cijepljenih prije graviditeta i/ili s poznatim ili suspektnim prethodnim izlaganjem patogenima, prvo cijepljenje treba odgoditi do dobi od 12 tjedana.
English: 2 egg infective dose 50%
Croatian: 2 količina virusa koja zarazi 50 posto oplođenih jaja u koja se virus ucijepi
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Croatian: Dostupni su podaci o neškodljivosti i učinkovitosti koji pokazuju da se ova vakcina može miješati i primijeniti s Merialovom vakcinom protiv mačje leukemije i/ili primijeniti isti dan, ali se ne smije miješati s Merialovom vakcinom protiv bjesnoće.
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against Chlamydophila felis infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs.
Croatian: Aktivna imunizacija mačaka starijih od 8 tjedana: - protiv virusnog rinotraheitisa mačaka za smanjenje kliničkih znakova, - protiv infekcije kalicivirusom za smanjenje kliničkih znakova,
English: In very rare cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.
Croatian: U vrlo rijetkim slučajevima primijećena je hipertermija i letargija ponekad povezana sa šepanjem jedan do tri tjedna nakon revakcinacije u odraslih mačaka.
English: Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the chlamydiosis component and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Croatian: Docjepljivanje: - prva revakcinacija mora se provesti za sve komponente jednu godinu nakon prvog cijepljenja, - naknadne revakcinacije moraju biti provedene svake godine za klamidiozu i u intervalima od najviše tri godine za komponente rinotraheitisa, kalicivirusa, i panleukopenije
English: If self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.
Croatian: Ako dođe do samoinjiciranja, mora se odmah potražiti savjet liječnika a liječnik mora biti obaviješten da je došlo do samoinjiciranja živim cjepivom protiv klamidije.
English: In very rare* cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.
Croatian: U vrlo rijetkim* slučajevima primijećena je hipertermija i letargija ponekad povezana sa šepanjem jedan do tri tjedna nakon revakcinacije u odraslih mačaka.
English: Lyophilisate (10xdose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Croatian: Liofilizat (10 x 1 doza) + otapalo (10 x 1 ml) Liofilizat (50 x 1 doza) + otapalo (50 x 1ml)
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti pomiješano s cjepivom protiv mačje leukemije tvrtke Merial i/ili primijenjeno istog dana ali ne pomiješano s cjepivom protiv bjesnoće tvrtke Merial.
English: Gentamicin, at most .......................................................................................................................... 28 µg Solvent:
Croatian: Gentamicin, najviše .......................................................................................................................... 28 µg
English: The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the Chlamydophila felis component.
Croatian: Trajnost imuniteta nakon zadnje re-vakcinacije je 3 godine za komponente rinotraheitisa, kaliciviroze, panleukopenije i 1 godinu za komponentu Chlamydophila felis .
English: Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Croatian: Nakon rekonstitucije liofilizata s otapalom injicirajte supkutano jednu dozu (1 ml) cjepiva, prema slijedećem rasporedu cijepljenja:
English: Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Croatian: Po dozi od 1ml: FHV (soj F2) ...................................................................................................................... ≥ 104,9 CCID50
English: Water for injections ..................................................................................................................... q.s.
Croatian: Voda za injekcije ......................................................................................................................... q.s. 1 ml.
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous
Croatian: Dinatrij hidrogen ortofosfat Monokalij fosfat anhidrid
English: Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml solvent, both closed with a butyl elastomer closure and sealed with an aluminium or plastic cap.
Croatian: I staklena bočica s 1 ml otapala, obje zatvorene gumenim čepom i aluminijskom ili plastičnom kapicom.
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components.
Croatian: Pokazalo se da imunitet nastupa 1 tjedan nakon prvog cijepljenja protiv rinotraheitisa, kalicivirusa, Chlamydophila felis i komponente panleukopenije.
English: 1 cell culture infective dose 50%
Croatian: 1 količina virusa koja zarazi 50 posto stanica kulture u koju je dodan virus 2 količina virusa koja zarazi 50 posto oplođenih jaja u koja se virus ucijepi
English: Purevax RCPCh lyophilisate and solvent for suspension for injection
Croatian: Purevax RCPCh liofilizat i otapalo za suspenziju za injekcije
English: Purevax RCPCh Lyophilisate and solvent for suspension for injection.
Croatian: Purevax RCPCh Liofilizat i otapalo za suspenziju za injekcije.
English: PACKAGE LEAFLET FOR: Purevax RCPCh lyophilisate and solvent for suspension for injection
Croatian: UPUTA O VMP Purevax RCPCh liofilizat i otapalo za suspenziju za injekcije
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNIH TVARI I NOSITELJ
English: Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis and feline panleucopenia virus.
Croatian: Potiče aktivni imunitet protiv herpesvirusa rinotraheitisa mačaka, kaliciviroze mačaka, klamidioze mačaka i virusa panleukopenije mačaka.
English: Water for injection ...................................................................................................................... q.s.
Croatian: Voda za injekcije ......................................................................................................................... q.s. 1 ml. 1 količina virusa koja zarazi 50 posto stanica kulture u koju je dodan virus
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis, chlamydiosis and feline panleucopenia.
Croatian: Cjepivo protiv virusnog rinotraheitisa mačaka, kaliciviroze mačaka, klamidioze mačaka i panleukopenije mačaka.
English: Wash hands after use.
Croatian: Operite ruke nakon uporabe.
English: Mortality was the principal criteria for efficacy.
Croatian: Smrtnost je bila glavni kriterij djelotvornosti.
English: Therefore this indication was removed.
Croatian: Stoga je ta indikacija uklonjena.
English: ATCvet code: QA07AA92.
Croatian: ATCvet kôd: QA07AA92.
English: However, the same EFSA document also states that:
Croatian: Međutim, u istom dokumentu EFSA-e navodi se i sljedeće:
English: The study was conducted under the principles of Good Clinical Practice.
Croatian: Studija je provedena u skladu s načelima dobre kliničke prakse.
English: A disease shall be included on the list if it has been assessed in accordance with Article 7.
Croatian: Bolest se uvrštava na popis ako je procijenjena u skladu s člankom 7.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 g sadržava:
English: Human and animal bacteria share the same resistance determinants.
Croatian: Ljudske i životinjske bakterije imaju iste determinante otpornosti.
English: Drinking systems should be clean and free of rust to avoid reduction of activity.
Croatian: Sustavi za piće trebaju biti čisti i bez hrđe kako bi se izbjeglo smanjenje aktivnosti.
English: Average daily water intake (l/animal)
Croatian: Prosječni dnevni unos vode (l/životinji)
English: • The restriction of the indications to those that are adequately substantiated by efficacy data;
Croatian: • ograničavanjem indikacija na one koje su odgovarajuće potkrijepljene podatcima o djelotvornosti;
English: This is stated in the Regulation (EC) No 2160/20039 and based on the EFSA Opinion (2004)11.
Croatian: To se navodi u Uredbi (EZ) br. 2160/20039 i temelji se na mišljenju EFSA-e (2004.)11.
English: The harmonisation of withdrawal periods was based on the better conducted and most reliable studies.
Croatian: Usklađivanje razdoblja karencije temeljilo se na bolje provedenim i najpouzdanijim studijama.
English: Therefore, the CVMP concluded that the proposed indication was justified.
Croatian: Stoga je CVMP zaključio da je predložena indikacija opravdana.
English: The possible risk for the environment has not been considered as part of this referral.
Croatian: Mogući rizik za okoliš nije se smatrao dijelom ovog postupka upućivanja.
English: MIC90 was 8 μg/ml or less.
Croatian: MIK90 iznosio je 8 μg/ml ili manje.
English: All calves were subjected to a full clinical examination daily for at least the first week of each trial.
Croatian: Sva telad podvrgnuta je cjelovitom dnevnom kliničkom ispitivanju barem tijekom prvog tjedna svakog ispitivanja.
English: If irritation persists, seek medical advice.
Croatian: Ako se iritacija nastavi, potražite savjet liječnika.
English: Those measures may cover, for example, prohibitions and restrictions on the use of veterinary medicinal products.
Croatian: Te mjere mogu obuhvaćati, na primjer, zabranu i ograničenja primjene veterinarsko-medicinskih proizvoda.
English: Swelling of the face, lips and eyes or difficult breathing are more serious symptoms and require urgent medical assistance.
Croatian: Oticanje lica, usana i očiju ili teško disanje ozbiljniji su simptomi te zahtijevaju hitnu medicinsku pomoć.
English: Animals with acute or severe clinical conditions that cannot drink, should receive adequate parenteral treatment.
Croatian: Životinje s akutnim ili teškim kliničkim stanjem, koje ne mogu piti, trebaju dobiti odgovarajuće parenteralno liječenje.
English: The scope of the re-examination was the shelf life of the product prior to first opening which was reduced from 3 years to 18 months.
Croatian: Ponovna procjena odnosila se na rok valjanosti proizvoda prije prvog otvaranja koji je skraćen s 3 godine na 18 mjeseci.
English: Additionally, the shelf life has been reduced to 18 months.
Croatian: Osim toga, rok valjanosti skraćen je na 18 mjeseci.
English: Res. Vol. 4(9), pp. 796-800
Croatian: Vol. 4(9), pp. 796-800
English: Sachets are packed in cardboard boxes containing 50 sachets.
Croatian: Pakiraju se u kartonske kutije koje sadržavaju 50 vrećica.
English: Not for use in birds producing or intended to produce eggs for human consumption.
Croatian: Nije odobrena primjena na nesilicama koje proizvode ili su namijenjene za proizvodnju jaja za ljudsku upotrebu.
English: If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Croatian: Ako to nije moguće, terapiju treba temeljiti na lokalnim (regionalnim, na razini farme) epidemiološkim podacima o osjetljivosti ciljnih bakterija.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name>
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA <Izmišljeni naziv>
English: Absorption: Absorption may be high in new-born animals but rapidly decreases in the first weeks of life.
Croatian: Apsorpcija može biti visoka kod novorođenih životinja, ali se brzo smanjuje tijekom prvih tjedana života.
English: Do not exceed the recommended dose.
Croatian: Ne davati doze veće od preporučenih.
English: Data for 36 months was presented for 3 batches of finished product packaged in the final containers (bottles, bags and two different size sachets).
Croatian: Podatci za 36 mjeseci predstavljeni su za tri serije završnog proizvoda pakiranog u završne spremnike (boce, vreće i vrećice u dvjema veličinama).
English: Furthermore, in this sense, the European Commission shall adopt delegated acts in accordance with Article 264 concerning amendments to the list referred.
Croatian: Nadalje, Europska komisija u tom pogledu donosi delegirane akte u skladu s člankom 264. radi izmjene tog popisa.
English: Lilly France 24 Boulevard Vital Bouhot
Croatian: Francuska Lilly France 24 Boulevard Vital Bouhot
English: Bottle (booklet) and bag (label)
Croatian: Boca (letak) i vreća (etiketa)
English: Although the respiratory route is considered a significant mode of entry, antimicrobials are expected to act at the site of infection.
Croatian: Iako se dišni put smatra značajnim načinom ulaska, od antimikrobnih lijekova očekuje se da djeluju na mjestu infekcije.
English: Once opened, use immediately.
Croatian: Jednom otvoren odmah upotrijebiti.
English: The results obtained showed statistically significant difference on mortality between all the apramycin medicated groups and the unmedicated control groups.
Croatian: Dobiveni rezultati pokazuju statistički značajnu razliku u pogledu smrtnosti između svih skupina liječenih apramicinom i kontrolnih neliječenih skupina.
English: The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2015.
Croatian: European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in
English: Pharmacotherapeutic group: Intestinal antiinfectives, antibiotics.
Croatian: FARMAKOLOŠKA SVOJSTVA Farmakoterapijska grupa: intestinalni antiinfektivi, antibiotici.