FrancophonIA/ELRC3.0 huggingface dataset:
English: Lumark is only used by specialists who have experience in radiolabelling.
Croatian: Lumark smiju primjenjivati samo specijalisti koji imaju iskustva u radioaktivnom označavanju.
English: Radiolabelling is a technique for tagging (or labelling) medicines with radioactive compounds so they can carry radioactivity to where it is needed in the body, for example, the site of a tumour.
Croatian: Radioaktivno označavanje tehnika je označavanja (ili obilježavanja) lijekova radioaktivnim spojevima kako bi mogli prenositi radioaktivnost do mjesta u tijelu gdje je to potrebno, primjerice do mjesta tumora.
English: Why is Lumark authorised in the EU?
Croatian: Zašto je lijek Lumark odobren u EU-u?
English: Radiolabelling with Lumark takes place in a laboratory.
Croatian: Radioaktivno označavanje lijekom Lumark provodi se u laboratoriju.
English: As with all radiolabelling materials for medicines, there are risks linked to radiation exposure from Lumark.
Croatian: Kao i u slučaju svih materijala za radioaktivno označavanje za lijekove, postoje rizici povezani s izlaganjem zračenju od lijeka Lumark.
English: Information on how to minimise the risks is included in the product information for Lumark.
Croatian: Informacije o tome kako minimizirati rizike uključene su u informacije o lijeku Lumark.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lumark 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 Lumark nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: When a medicine is radiolabelled with Lumark, the medicine carries the radiation to where it is needed in the body, either to kill cancer cells (when used for treatment) or to obtain images on a screen (when used for diagnosis).
Croatian: Lijek radioaktivno označen lijekom Lumark prenosi radioaktivnost do mjesta u tijelu gdje je to potrebno ili za uništavanje stanice raka (ako se koristi za liječenje) ili da bi se dobile slike na zaslonu (ako se koristi za postavljanje dijagnoze).
English: The radiolabelled medicine is then given to the patient according to the instructions in that medicine's product information.
Croatian: Radioaktivno označen lijek potom se daje bolesniku u skladu s uputama u informacijama o dotičnom lijeku.
English: An overview of Lumark and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Lumark i zašto je odobren u EU-u
English: What are the risks associated with Lumark?
Croatian: Koji su rizici povezani s lijekom Lumark?
English: The doctor will ensure that the expected benefit to the patients of using Lumark outweigh the risks linked to the radioactivity.
Croatian: Liječnik će voditi računa da očekivane koristi lijeka Lumark za bolesnika nadmaše rizike povezane s radioaktivnošću.
English: Lumark itself is radioactive, and as with any other radioactive product, its use may carry a risk of developing cancer and hereditary defects.
Croatian: Lumark je sam po sebi radioaktivan te njegova primjena, kao i u slučaju svih ostalih radioaktivnih lijekova, može predstavljati rizik od razvoja raka i nasljednih oštećenja.
English: How does Lumark work?
Croatian: Kako djeluje Lumark?
English: Lumark is never given to a patient on its own.
Croatian: Lumark se nikada ne primjenjuje u bolesnika kao monoterapija.
English: As for all medicines, data on the use of Lumark are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Lumark kontinuirano se prate.
English: The active substance in Lumark, lutetium (177Lu) chloride, is a radioactive compound that mainly releases beta radiation, with small amounts of gamma radiation.
Croatian: Djelatna tvar lijeka Lumark, lutecijev (177Lu) klorid, radioaktivan je spoj koji uglavnom otpušta betazračenje uz malu količinu gama-zračenja.
English: Information on restrictions that apply specifically to medicines radiolabelled with Lumark can be found in the package leaflets of those medicines.
Croatian: Informacije o ograničenjima koja se odnose posebice na lijekove radioaktivno označene lijekom Lumark, navedene su u uputi o lijeku za te lijekove.
English: The side effects with Lumark depend largely on the medicine it is used with and are described in that medicine's package leaflet.
Croatian: Nuspojave lijeka Lumark uvelike ovise o lijeku s kojim se koristi i opisane su u uputi o lijeku za dotični lijek.
English: Lumark is to be used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.
Croatian: Lumark se upotrebljava za radioaktivno označavanje lijekova koji su posebno razvijeni za primjenu s lutecijevim (177Lu) kloridom.
English: How well Lumark works will largely depend on the medicine that it is used to radiolabel.
Croatian: Koliko dobro Lumark djeluje uvelike će ovisiti o lijeku koji se radioaktivno označava.
English: The Agency concluded that the benefits of Lumark outweigh the risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Lumark nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The European Medicines Agency considered that the use of lutetium (177Lu) for radiolabelling medicines was well established and well documented in the scientific literature.
Croatian: Europska agencija za lijekove zaključila je da je primjena lutecija (177Lu) za radioaktivno označavanje lijekova ustaljena i dobro dokumentirana u znanstvenoj literaturi.
English: Several published studies have established the usefulness of lutetium (177Lu) in radiolabelling medicines for diagnosing and treating neuroendocrine tumours.
Croatian: U nekoliko objavljenih ispitivanja utvrdila se korisnost lutecija (177Lu) u radioaktivnom označavanju lijekova za dijagnosticiranje i liječenje neuroendokrinih tumora.
English: Because the use of lutetium (177Lu) to radiolabel medicines is well established, the company presented data from the scientific literature.
Croatian: Budući da je primjena lutecija (177Lu) za radioaktivno označavanje lijekova već ustaljena, tvrtka je dostavila podatke iz znanstvene literature.
English: Lumark contains the radioactive compound lutetium (177Lu) chloride and is used for radiolabelling other medicines.
Croatian: Lumark sadrži radioaktivni spoj lutecijev (177Lu) klorid i koristi se za radioaktivno označavanje drugih lijekova.
English: What benefits of Lumark have been shown in studies?
Croatian: Koje su koristi od lijeka Lumark utvrđene u ispitivanjima?
English: For the list of all side effects and restrictions with Lumark, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja vezanih uz primjenu lijeka Lumark potražite u uputi o lijeku.
English: Lu) chloride)
Croatian: Lumark (lutecijev (177Lu) klorid)
English: How is Lumark used?
Croatian: Kako se Lumark primjenjuje?
English: Animals should be re-examined every 6 months during treatment.
Croatian: Životinje treba ponovo pregledati svakih 6 mjeseci tijekom liječenja.
English: See also 4.3 Contraindications.
Croatian: Vidi također 4.3 kontraindikacije.
English: Ensure the dose used to achieve the therapeutic effect is as low as possible.
Croatian: Osigurajte da doza koja se koristi za postizanje terapijskog učinka bude niža što je više moguće.
English: Do not store above 30°C.
Croatian: Ne skladištiti na temperaturi iznad 30 ° C.
English: Do not use more than 2 tablets per dog per day.
Croatian: Ne koristite više od 2 tablete po psu dnevno.
English: Dogs (bitches).
Croatian: Psi (kuje)
English: Pharmacotherapeutic group: estrogens, ATCvet code: QG03CA04.
Croatian: Farmakoterapijska skupina: estrogeni, ATCvet kod: QG03CA04.
English: The minimum dose given should not be less than 0.5 mg per dog per day.
Croatian: Najmanja doza koja se daje ne bi trebala biti manja od 0,5 mg po psu dnevno.
English: Further, in some dogs, symptoms of nausea were observed.
Croatian: Nadalje, kod nekih pasa primijećeni su simptomi mučnine.
English: Date of last renewal: March 2010
Croatian: Datum zadnje obnove odobrenja: ožujak 2010
English: These effects are reversible after lowering the dose.
Croatian: Ovi učinci su reverzibilni nakon snižavanja doze.
English: Each strip is packed in a carton box.
Croatian: Svaka traka je zapakirana u kartonsku kutiju.
English: SPECIAL WARNINGS, IF NECESSARY Not applicable.
Croatian: POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO
English: In rare cases vaginal bleeding occurred.
Croatian: U rijetkim slučajevima vaginalno krvarenjedogodilo.
English: Nearly the whole Estriol is bound to Albumin in Plasma.
Croatian: Gotovo cijeli estriol se veže sa albuminima u plazmi.
English: If no response to treatment is obtained the diagnosis should be reconsidered in order to investigate other causes for the incontinence such as neurological disorders, bladder neoplasia, etc.
Croatian: Ukoliko nema odgovora na terapiju, dijagnozu treba razmotriti, kako bi se istražilo i druge moguće uzroke inkontinencije, kao što su neurološki poremećaji, neoplazije mokraćnog mjehura, itd.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Croatian: Za bilo kakve informacije o ovom veterinarsko-medicinskom proizvodu, obratite se lokalnim predstavnicima nositelja odobrenja.
English: In rare cases development of alopecia has also been observed.
Croatian: U rijetkim slučajevima je također primijećen razvoj alopecije.
English: In case of oestrogenic effects, the dose should be lowered.
Croatian: U slučaju estrogenskog učinka, dozu treba smanjiti.
English: Animals showing a polyuria-polydipsia should not be treated with Incurin.
Croatian: Životinje koje pokazuju poliuriju i polidipsiju ne smiju biti tretirane sa Incurinom.
English: The use of Incurin is contraindicated during pregnancy, lactation and in animals younger than 1 year.
Croatian: Korištenje Incurina je kontraindicirano tijekom graviditeta, dojenja i kod životinja mlađih od 1 godine
English: In the target animal safety study and the clinical trials, including long-term treatment, no signs of bone marrow suppression were observed.
Croatian: Kod ciljnih životinja u ispitivanjima neškodljivosti i kliničkim ispitivanjima, uključujući i dugotrajna liječenja, nije bilo znakova supresije koštane srži.
English: Estriol is excreted in conjugated from via the urine.
Croatian: Estriol se izlučuje u konjugiranih od preko urina.
English: EXPIRY DATE Exp (Month / year)
Croatian: ROK VALJANOSTI Exp (mjesec / godina)
English: 1 mg/tablet
Croatian: 1 mg/tableta
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/018/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/00/018/001
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Croatian: 11. POSEBNI UVIJETI ČUVANJA Ne skladištiti na temperaturi iznad 30°C.
English: For oral administration.
Croatian: Za peroralnu primjenu.
English: Do not use after the expiry date which is stated on the label after Exp.
Croatian: Nemojte koristiti nakon isteka roka valjanosti navedenog na etiketi
English: PHARMACEUTICAL FORM Tablet.
Croatian: OBLIK Tableta.
English: The incidence is about 59 %.
Croatian: Incidencija je oko 5
English: Aspen Oss.
Croatian: Aspen Oss B.V.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Croatian: Ukoliko primijetite nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da se javite veterinaru.
English: 6.5 Nature and composition of immediate packaging Blister package of clear PVC film backed by aluminium foil provided with heat seal coating (vinyl copolymer) on the side in contact with the tablets.
Croatian: Blister pakovanje od PVC filma potpomognuto aluminijskom folijom osigurana topline pečat premazom (vinil kopolimera) na strani u kontaktu s tabletama.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Svaki neiskorišteni veterinarsko-medicinski proizvod ili otpadni materijal dobiven iz veterinarsko medicinskih proizvoda mora se odlagati u skladu s lokalnim uvjetima.
English: High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary glands).
Croatian: Visoke doze estrogena mogu imati protumorski učinak u ciljnim organima s estrogenim receptorima (mliječne žlijezde).
English: In case of overdose typical oestrogen effects may occur.
Croatian: U slučaju predoziranja mogu se pojaviti tipični estrogeni učinci.
English: This is probably due to the short-acting oestrogenic character of estriol.
Croatian: To je vjerojatno zbog kratkog djelovanja estrogenog učinka estriola.
English: The following dosing schedule is advised: start treatment with 1 tablet (1 mg estriol) every day.
Croatian: Savjetuje se slijedeći raspored doziranja: započeti s 1 tabletom (1 mg estriol) svaki dan.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Croatian: I POGLEDA DJECE” Čuvati izvan dosega i pogleda djece.
English: To be supplied only on veterinary prescription
Croatian: Može se izdavati samo na veterinarski recept
English: A relationship between final effective dose and body weight has not been established and therefore the dose has to be determined for each dog on an individual basis.
Croatian: Odnos između konačne efektivne doze i tjelesne težine nije utvrđen, a time i doza mora biti utvrđena za svakog psa na individualnoj osnovi.
English: After oral administration of multiple doses no accumulation occurs.
Croatian: Nakon peroralne primjene više doze nema akumulacije događa.
English: PACKAGE SIZE Carton box with 1 blister.
Croatian: VELIČINA PAKOVANJA Kartonska kutija sa 1 blisterom.
English: Upon oral administration a steady state is reached after the second treatment day and no accumulation occurs after multiple dosing.
Croatian: Nakon peroralne primjene ravnotežno stanje se postiže nakon drugog dana tretmana i nema akumulacije nakon primjene višestruke doze.
English: Estriol is a short-acting natural oestrogen.
Croatian: Estriol je kratko-djelujući prirodni estrogen.
English: After oral administration Estriol is nearly completely absorbed from gastrointestinal tract.
Croatian: Nakon peroralne primjene gotovo sav estriol se apsorbira iz gastrointestinalnog trakta.
English: Pack size: carton box with 1 blister
Croatian: Veličina pakovanja: karton kutija sa 1 blisterom
English: Oestrogenic effects such as swollen vulva, swollen mammary glands and/or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog.
Croatian: Estrogeni učinci kao što su oticanje stidnice, natečenost mliječne žlijezde i/ili privlačenje mužjaka i povraćanje su primijećene pri najvišim preporučenim dozama od 2 mg po psu.
English: SPECIAL STORAGE CONDITIONS Keep out of the reach and sight of children.
Croatian: 11. POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE Čuvati izvan dosega i pogleda djece.
English: Some dogs do not need daily treatment; treatment every other day may be tried, once the effective daily dose has been established.
Croatian: Neki psi ne trebaju dnevni tretman, može se primijeniti tretman svaki drugi dan, nakon što je uspostavljena efektivna dnevna doza.
English: One blister contains 30 tablets.
Croatian: Jedan blister sadržava 30 tableta.
English: Do not use in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches.
Croatian: Ne koristiti kod intaktnih kuja, jer je djelotvornost jedino uspostavljena u ovariohisterektomiranih kuja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: estriol
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Croatian: Wim de Körverstraat 35 5831 Boxmeer Nizozemska
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere predostrožnosti za odlaganje neupotrjebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: EXPIRY DATE (Month / year)
Croatian: ROK VALJANOSTI (Mjesec / godina)
English: 11 PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Croatian: ZABRANA PRODAJE, OPSKRBE I/ILI PRIMJENE
English: In ovarioectomised female dogs it has a beneficial effect on urinary incontinence.
Croatian: U ovarioektomiziranih kuja ima blagotvoran učinak na urinarnu inkontinenciju.
English: Amylopectin Potato starch Magnesium stearate Lactose
Croatian: Magnezij stearat Laktoza
English: OTHER INFORMATION Each push-through strip contains 30 tablets.
Croatian: 15. OSTALE INFORMACIJE Svaka blister traka sadrži 30 tableta.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE VMP U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE PROIZVODNE SERIJE, AKO JE RAZLIČITO
English: ADVICE ON CORRECT ADMINISTRATION Not applicable.
Croatian: SAVJETI ZA ISPRAVNU PRIMJENU
English: Each blister contains 30 tablets.
Croatian: Blister sadrži 30 tableta.
English: In the incontinent female dog it has a beneficial effect on the urinary incontinence.
Croatian: U intaktnih kuja ima blagotvoran učinak na urinarnu inkontinenciju.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Croatian: Intervet International B.V.
English: Do not use this product during pregnancy or lactation.
Croatian: 4.7 Primjena tijekom graviditeta, laktacije ili nesenja Nemojte koristiti ovaj proizvod tijekom graviditeta ili dojenja.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Croatian: Naziv i adresa proizvođača biološki djelatne tvari
English: Round single-scored tablets.
Croatian: Okrugla tableta.
English: 6.2 Incompatibilities
Croatian: 6.2 Inkompatibilnosti Nisu poznate.
English: Because of its short acting action, oestriol does not induce bone marrow suppression in the dog.
Croatian: Zbog kratkog djelovanja, estriol ne potiče supresiju koštane srži u pasa.
English: Mild, oestrogenic effects such as swollen vulva, swollen teats and/or attractiveness for males have been observed at the high dose of 2 mg.
Croatian: Estrogeni učinci kao što su oticanje stidnice, natečenost mliječne žlijezde i/ili privlačenje mužjaka i povraćanje su primijećeni na najvišim preporučenim dozama od 2 mg.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I> NOSITELJ(I) ODOBRENJA ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: If treatment is successful, lower the dose to half a tablet a day.
Croatian: Ako je liječenje uspješno, smanjiti dozu na pola tablete dnevno.
English: MANUFACTURER'S BATCH NUMBER Batch number.
Croatian: 17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
English: 4.9 Amount(s) to be administered and administration route
Croatian: 4.9 Količine koje se primjenjuju i način primjene
English: If treatment is not successful, increase the dose to 2 tablets a day to be given in one dose.
Croatian: Ako liječenje ne uspije, povećati dozu na 2 tablete dnevno i dati u jednoj dozi.
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Croatian: UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU NEŠKODLJIVE I DJELOTVORNE PRIMJENE PROIZVODA
English: Because of its short-acting oestrogenic properties, Incurin does not induce bone marrow suppression in the dog.
Croatian: Zbog kratkotrajnog djelovanja estrogenih svojstava, Inkurin ne izaziva supresiju koštane srži u psa.
English: None.
Croatian: Pas
English: Incurin is indicated for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs.
Croatian: INDIKACIJE Incurin je indiciran za liječenje hormonski ovisne urinarne inkontinencije, zbog nekompetentnosti mehanizma sfinktera u kuja.
English: 7 MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET
English: 1 mg/tablet For a full list of excipients, see section 6.1
Croatian: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only - to be supplied only on veterinary prescription.
Croatian: Samo za primjenu na životinjama - izdaje se samo na veterinarski recept.
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Croatian: UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU NEŠKODLJIVE I DJELOTVORNE PRIMJENE
English: B.V. Kloosterstraat 6 5349 AB Oss The Netherlands
Croatian: 5349 AB Oss
English: Treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs.
Croatian: Liječenje hormonski uvjetovane urinarne inkontinencije, zbog nekompetentnosti sfinktera kod ovariohisterektomiranih kuja.
English: STATEMENT OF ACTIVE AND OTHER SUBTANCES Active substance: estriol 1 mg/tablet
Croatian: Djelatna tvar: estriol 1 mg/tableti
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE VMP U PROMET
English: PACKAGE LEAFLET INCURIN 1 mg tablet
Croatian: INCURIN 1 mg tableta
English: MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE BLISTER
Croatian: OSNOVNI PODACI NAPISANI NA BLISTERIMA
English: 6.4 Special precautions for storage
Croatian: Posebne mjere predostrožnosti za čuvanje
English: PHARMACEUTICAL FORM Round single-scored tablets
Croatian: Okrugla tableta
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv i adresa proizvođača odgovorna za puštanje serije u promet:
English: None known.
Croatian: Nije primjenjivo
English: 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Croatian: 6.1 Popis pomoćnih tvari
English: SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: BROJ PROIZVODNE SERIJE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX
Croatian: PODACI NA VANJSKOM PAKOVANJU OSOBINE/TIP
English: NAME OF THE VETERINARY MEDICINAL PRODUCT INCURIN 1 mg tablet.
Croatian: INCURIN 1 mg tableta.
English: Dog.
Croatian: C.
English: --1 Modified live Porcine Respiratory and Reproductive Syndrome Virus, strain 96V198: 102.2 - 105.2 CCID50* per 2 ml *Cell culture infectious dose 50%
Croatian: --1 Modificirani živi Virus respiratornog i reproduktivnog sindroma svinja PRRSV*, soj 96V198: 102.2 - 105.2 CCID50 *Doza virusa koja inficira 50 % uzoraka stanične kulture
English: Dogs should be treated for as long as is needed.
Croatian: Pse treba liječiti onoliko dugo koliko je potrebno.
English: Further information on Onsior can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u Onsior nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The tablets are given once a day at the same time every day, at a dose range of 1 - 2.4 mg per kg bodyweight depending on whether one or two tablets are required.
Croatian: Tablete se daju jedanput na dan svakog dana u isto doba, u rasponu doziranja od 1 do 2,4 mg po kilogramu tjelesne težine, ovisno o tome je li potrebna jedna ili dvije tablete.
English: Onsior (robenacoxib)
Croatian: Onsior (robenakoksib)
English: The solution for injection can also cause pain on injection.
Croatian: Otopina za injekciju može prouzročiti i bol pri ubrizgavanju.
English: Onsior received a marketing authorisation valid throughout the EU on 16 December 2008.
Croatian: Za VMP Onsior izdano je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 16. prosinca 2008.