FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Bovilis BTV8:
Croatian: Druge informacije o VMP-u Bovilis BTV8:
English: Bovilis BTV8 is a vaccine.
Croatian: Bovilis BTV8 je cjepivo.
English: What is the risk associated with Bovilis BTV8?
Croatian: Koji su rizici povezani s VMP-om Bovilis BTV8?
English: Why has Bovilis BTV8 been approved?
Croatian: Zašto je Bovilis BTV8 odobren?
English: What is Bovilis BTV8?
Croatian: Što je Bovilis BTV8?
English: What benefit has Bovilis BTV8 shown during the studies?
Croatian: Koje koristi Bovilis BTV8 su utvrđene tijekom ispitivanja?
English: What is Bovilis BTV8 used for?
Croatian: Za što se Bovilis BTV8 koristi?
English: How does Bovilis BTV8 work?
Croatian: Na koji način Bovilis BTV8 djeluje?
English: How has Bovilis BTV8 been studied?
Croatian: Kako se Bovilis BTV8 ispitivao?
English: It is given by injection under the skin, once a day.
Croatian: Daje se injekcijom pod kožu jednom dnevno.
English: This summary was last updated in 02-2018.
Croatian: Sažetak je posljednji put ažuriran u 02. 2018.
English: The diagnosis must be confirmed by genetic testing.
Croatian: Dijagnoza se mora potvrditi genetskim testiranjem.
English: • do not grow normally because they do not have enough growth hormone;
Croatian: • koja ne rastu normalno jer nemaju dovoljno hormona rasta;
English: As with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Omnitrope).
Croatian: Kao što je slučaj sa svim proteinskim lijekovima, neki bolesnici mogu razviti antitijela (proteine koji se proizvode kao reakcija na lijek Omnitrope).
English: It must also not be used for promoting growth in children with closed epiphyses (when the large bones have finished growing).
Croatian: Ne smije se također primjenjivati za poticanje rasta u djece sa zatvorenim epifizama (kad velike kosti prestanu rasti).
English: The full EPAR for Omnitrope can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Omnitrope nalazi se na internetskim stranicama Agencije: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Children receiving Omnitrope and Genotropin grew at a similar rate of about 10.7 cm per year.
Croatian: Djeca koja su primala Omnitrope i Genotropin rasla su sličnom brzinom od oko 10,7 cm na godinu.
English: • have a genetic condition called Prader-Willi syndrome.
Croatian: • s genetskim stanjem pod nazivom Prader-Willijev sindrom.
English: The dose may need to be adjusted over time, depending on change in body weight and response to treatment.
Croatian: Doza će se možda tijekom vremena trebati prilagođavati, ovisno o promjeni tjelesne težine i odgovoru na liječenje.
English: What is Omnitrope and what is it used for?
Croatian: Što je Omnitrope i za što se koristi?
English: These side effects are uncommon in children (may affect between 1 and 10 patients in 1,000).
Croatian: Takve nuspojave manje su česte u djece (u 1 do 10 bolesnika na 1 000).
English: In adults, side effects related to fluid retention, such as peripheral oedema (swelling, especially of the ankles and feet), paraesthesia (numbness or tingling), joint and muscle pain, and stiffness of the limbs are common (may affect between 1 and 10 patients in 100).
Croatian: Nuspojave povezane sa zadržavanjem tekućine, kao što su periferni edem (oticanje, posebno gležnjeva i stopala), parestezija (trnci ili utrnulost), bol u zglobovima i mišićima te ukočenost udova česte su u odraslih osoba (mogu se pojaviti u 1 do 10 na 100 bolesnika).
English: Somatropin is produced by a method known as ‘recombinant DNA technology': the hormone is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce somatropin.
Croatian: Somatropin se proizvodi metodom poznatom pod nazivom „tehnologija rekombinantne DNK”: hormon se stvara od bakterija u koje je uveden gen (DNK) kako bi mogle proizvoditi somatropin.
English: • are short because they have long-term kidney disease or a genetic disorder called Turner syndrome;
Croatian: • koja su niska zbog dugotrajne bolesti bubrega ili genetskog poremećaja koji se naziva Turnerov sindrom;
English: The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment.
Croatian: Deficit može nastupiti u odrasloj dobi ili u djetinjstvu te se prije liječenja treba potvrditi testiranjem.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Omnitrope on 12 April 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Omnitrope u promet koje vrijedi na prostoru Europske unije od 12. travnja 2006.
English: The European Medicines Agency considered that, in accordance with EU requirements for biosimilar medicines, Omnitrope has been shown to have a comparable quality, safety and effectiveness to Genotropin.
Croatian: Europska agencija za lijekove smatrala je da je, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Omnitrope pokazao usporedivu kvalitetu, sigurnost i učinkovitost kao i Genotropin.
English: Omnitrope is given to improve their growth and body composition (by reducing fat and improving muscle mass).
Croatian: Omnitrope se daje za poboljšanje njihova rasta i građe tijela (smanjenjem masnog tkiva i povećanjem mišićne mase).
English: This means that Omnitrope is highly similar to a biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, lijek Omnitrope vrlo je sličan biološkom lijeku („referentnom lijeku”) koji je već odobren u EU-u.
English: Results showed that, after treatment for 9 months, Omnitrope was as effective as Genotropin in improving growth.
Croatian: Rezultati su pokazali da je nakon devet mjeseci liječenja Omnitrope bio jednako djelotvoran kao i Genotropin u poboljšanju rasta.
English: The doctor calculates the dose for each patient individually according to the body weight and the condition being treated.
Croatian: Dozu izračunava liječnik za svakog bolesnika posebno, u skladu s tjelesnom težinom i stanjem koje se liječi.
English: Omnitrope was compared with Genotropin in 89 children with a lack of growth hormone who had not been treated before.
Croatian: Omnitrope je uspoređen s lijekom Genotropin u 89 djece s nedostatkom hormona rasta koja prethodno nisu liječena.
English: This is a summary of the European public assessment report (EPAR) for Omnitrope.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Omnitrope.
English: • are short and were born small for their gestational age, and have not caught up by the age of
Croatian: • koja su niska i rođena mala za svoju gestacijsku dob te koja nisu uspjela nadoknaditi zaostajanje u rastu do dobi od 4 godine ili kasnije;
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Omnitrope 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 Omnitrope nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Other information about Omnitrope
Croatian: Ostale informacije o lijeku Omnitrope
English: Therefore, the Agency's view was that, as for Genotropin, the benefit outweighs the identified risk and it recommended that Omnitrope be given marketing authorisation.
Croatian: Stoga je mišljenje Agencije da, kao i kod lijeka Genotropin, koristi nadmašuju utvrđene rizike te je preporučila davanje odobrenja za stavljanje lijeka Omnitrope u promet.
English: It is important for growth during childhood and adolescence, and it also affects how the body handles proteins, fat and carbohydrates.
Croatian: Ona je važna za rast u djetinjstvu i u odrasloj dobi te utječe i na metabolizam bjelančevina, masti i ugljikohidrata u tijelu.
English: Omnitrope is also used as replacement therapy in adult patients with pronounced growth hormone deficiency.
Croatian: Omnitrope se također primjenjuje kao nadomjesna terapija u odraslih bolesnika s izraženim deficitom hormona rasta.
English: Omnitrope can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with growth disorders.
Croatian: Omnitrope se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju bolesnika s poremećajima rasta.
English: The reference medicine for Omnitrope is Genotropin.
Croatian: Referentni lijek za lijek za Omnitrope je Genotropin.
English: Omnitrope must not be used if the patient has an active tumour or an acute life-threatening illness.
Croatian: Omnitrope ne smiju uzimati bolesnici koji imaju aktivan tumor ili akutnu bolest opasnu po život.
English: Omnitrope is a medicine used to treat children who:
Croatian: Omnitrope je lijek koji se primjenjuje u liječenju djece:
English: For more information about treatment with Omnitrope, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Omnitrope pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: What measures are being taken to ensure the safe use of Omnitrope?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna primjena lijeka Omnitrope?
English: The Omnitrope cartridges should only be used with the special Omnitrope injection device.
Croatian: Ulošci s lijekom Omnitrope trebali bi se upotrebljavati samo s posebnom injekcijskom napravom za Omnitrope.
English: What are the risks associated with Omnitrope?
Croatian: Koji su rizici povezani s lijekom Omnitrope?
English: The active substance in Omnitrope, somatropin, is identical to the human growth hormone, which it replaces.
Croatian: Djelatna tvar u lijeku Omnitrope, somatropin, identična je ljudskom hormonu rasta koji zamjenjuje.
English: The patient or caregiver can inject Omnitrope, after being trained by a doctor or a nurse.
Croatian: Omnitrope mogu ubrizgati bolesnik ili pružatelj skrbi nakon što su ih za to obučili liječnik ili medicinska sestra.
English: It is not intended to provide practical advice on how to use Omnitrope.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Omnitrope.
English: The medicine is available as a powder and solvent, which are made up into a solution for injection, or as a ready-to-use solution in a cartridge.
Croatian: Lijek je dostupan u obliku praška i otapala za otopinu za injekciju ili u obliku gotove otopine u ulošku.
English: Why is Omnitrope approved?
Croatian: Zašto je lijek Omnitrope odobren?
English: Omnitrope contains the active substance somatropin and is a ‘biosimilar' medicine.
Croatian: Omnitrope sadržava djelatnu tvar somatropin te je „biosličan lijek”.
English: Growth hormone is released by the pituitary gland (a gland at the base of the brain).
Croatian: Hormon rasta izlučuje hipofiza (žlijezda koja se nalazi u bazi mozga).
English: For practical information about using Omnitrope, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Omnitrope bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: What benefits of Omnitrope have been shown in studies?
Croatian: Koje su koristi lijeka Omnitrope utvrđene u ispitivanjima?
English: Omnitrope was studied to show that it is comparable to the reference medicine, Genotropin.
Croatian: Lijek Omnitrope ispitivan je kako bi se pokazala njegova usporedivost s referentnim lijekom, Genotropin.
English: How does Omnitrope work?
Croatian: Kako djeluje Omnitrope?
English: Howeve,r these antibodies do not have an effect on how well Omnitrope works.
Croatian: Međutim, ta antitijela ne utječu na djelotvornost lijeka Omnitrope.
English: How is Omnitrope used?
Croatian: Kako se Omnitrope koristi?
English: For the full list of side effects of Omnitrope, see the package leaflet.
Croatian: Potpuni popis nuspojava lijeka Omnitrope potražite u uputi o lijeku.
English: H-1114 Budapest Hungary
Croatian: H-1114 Budapest
English: E-08013 Barcelona Spain
Croatian: E-08013 Barcelona
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Croatian: POPIS NAZIVA, FARMACEUTSKIH OBLIKA, JAČINA LIJEKOVA, PUTEVA PRIMJENE,
English: 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France
Croatian: Francuska Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France
English: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes, 764
Croatian: Španjolska Novartis Farmacéutica S.A. Gran Via de les Corts
English: 2- 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France
Croatian: Francuska Novartis Pharma S.A.S. 2- 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France
English: 100mg/cap Capsule, soft
Croatian: 100mg/cap Kapsula, meka
English: 50mg/cap Capsule, soft
Croatian: 50mg/cap Kapsula, meka
English: Novartis Hungária Kft. Pharma részlege
Croatian: Mađarska Novartis Hungária Kft.
English: 25mg/cap Capsule, soft
Croatian: 25mg/cap Kapsula, meka
English: Belgium N.V. Novartis Pharma S.A. Medialaan 40,
Croatian: Novartis Pharma S.A. Medialaan 40, B-1800 Vilvoorde Belgium
English: International non-proprietary name (INN): eprinomectin
Croatian: Međunarodni nezaštićeni naziv (INN): eprinomektin
English: Article 33(4) of Directive 2001/82/EC, as amended
Croatian: Članak 33. stavak 4. Direktive 2001/82/EZ, s izmjenama
English: The decentralised procedure started on 21 February 2012.
Croatian: Decentralizirani postupak započet je dana 21. veljače 2012. godine.
English: The opinion was converted into a Decision by the European Commission on 21 March 2014.
Croatian: Europska komisija usvojila je mišljenje u obliku Odluke dana 21. ožujka 2014.
English: The referral procedure started on 15 May 2013.
Croatian: Postupak upućivanja započet je dana 15. svibnja 2013. godine.
English: Potential serious risks were identified during the decentralised procedure by Germany regarding the environmental safety of the product.
Croatian: Tijekom decentraliziranog postupka, Njemačka je identificirala potencijalne ozbiljne rizike vezane uz okolišnu sigurnost VMP-a.
English: Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle contains eprinomectin as an active substance and is intended for use in cattle as a topical application for the treatment and control of infections from gastrointestinal roundworms (adults and fourth stage larvae), lungworms (adults and fourth stage larvae), warbles (parasitic stages), mange mites, lice and horn flies.
Croatian: Norbonex 5 mg/ml otopina za polijevanje po koži goveda i mliječnih pasmina stoke sadrži eprinomektin kao djelatnu tvar i predviđena je za uporabu u stoke za topikalnu primjenu za liječenje i kontrolu infekcija uzrokovanih gastrointestinalnim oblićima (odraslima i u četvrtom stupnju ličinke), plućnim vlascima (odraslima i u četvrtom stupnju ličinke), štrkovima (stupnjevima parazita), šugarcima, ušima i rožnim muhama.
English: On 26 April 2013, the reference Member State, the United Kingdom, notified the Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Croatian: Dana 26. travnja 2013. godine, referentna država članica, Ujedinjeno Kraljevstvo, obavijestilo je Agenciju da CMD(v) nije postignuo sporazum u vezi sa VMP-om te da je predmet upućen CVMP-u sukladno članku 33. stavku 4. Direktive 2001/82/EZ.
English: The United Kingdom is the reference Member State and Germany and the Netherlands are concerned Member States.
Croatian: Njemačka i Nizozemska su države članice sudionice u postupku.
English: The Committee appointed C. Ibrahim as rapporteur and H. Jukes as co-rapporteur.
Croatian: Odbor je imenovao C.
English: Day 60 of the CMD(v) procedure was on 18 April 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Croatian: travnja 2013. godine bio je 60. dan postupka kojeg je provodio CMD(v), te s obzirom da države članice u postupku nisu uspjele postići sporazum u vezi sa VMP-om postupak je upućen CVMP-u.
English: Written explanations were provided by the applicant on 19 November
Croatian: Podnositelj zahtjeva dostavio je pisana pojašnjenja dana 19. studenog 2013. godine.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 18 February 2013.
Croatian: Ovi su problem ostali neriješeni 210. dana postupka, te je stoga 18. veljače 2013. godine započet postupak upućivanja sukladno članku 33. stavku 1. Direktive 2001/82/EZ od strane Koordinacijske grupe za postupak međusobnog priznavanja i decentralizirani postupak (veterina) (CMD(v)).
English: This is a ‘hybrid' application according to Article 13(3) of Directive 2001/82/EC, as amended, referring to the reference product Eprinex PourOn Solution for Beef and Dairy Cattle.
Croatian: Predmetni zahtjev predstavlja „hibridni” zahtjev u skladu sa člankom 13. stavkom 3. Direktive 2001/82/EZ, s izmjenama, u vezi s referentnim VMP-om Eprinex otopinom za polijevanje po koži goveda i mliječnih pasmina stoke.
English: Therefore, the Committee adopted by consensus a positive opinion on 15 January 2014 recommending the granting of the marketing authorisations for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle with amendment to the summary of product characteristics and package leaflet of the reference Member State.
Croatian: Stoga je Odbor konsenzusom usvojio pozitivno mišljenje dana 15. siječnja 2014. preporučajući izdavanje odobrenja za stavljanje u promet Norbonex 5 mg/ml otopine za polijevanje po koži goveda i mliječnih pasmina stoke s izmjenama navedenima u sažetku opisa svojstava VMP-a i upute za VMP referentne države članice.
English: The applicant, Norbrook Laboratories Ltd, submitted an application for a decentralised procedure for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle.
Croatian: Podnositelj zahtjeva, Norbrook Laboratories Ltd, dostavio je zahtjev za decentralizirani postupak za Norbonex 5 mg/ml otopinu za polijevanje po koži goveda i mliječnih pasmina stoke.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the summary of product characteristics and package leaflet in Annex III.
Croatian: Znanstveni su zaključci navedeni u Dodatku II, zajedno sa sažetkom opisa svojstava VMP-a i uputa za VMP u Dodatku III.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle is positive.
Croatian: Na temelju procijene trenutno dostupnih podataka, CVMP je razmotrio omjer koristi i rizika Norbonex 5 mg/ml otopine za polijevanje po koži goveda i mliječnih pasmina stoke.
English: Opinion following an Article 33(4)0F referral for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Croatian: Mišljenje nakon postupka upućivanja provedenog sukladno članku 33. stavku 4.0F za Norbonex 5 mg/ml otopinu za polijevanje po koži goveda i mliječnih pasmina stoke
English: EMA/128538/2014 Veterinary Medicines
Croatian: Veterinarsko-medicinski lijekovi
English: It can cause:
Croatian: Ona može uzrokovati:
English: Reversal should occur rapidly within 1-2 minutes.
Croatian: Oporavak bi se trebao dogoditi brzo, u roku od 1-2 minute.
English: • Your dog to feel cold when touched (for example the ears).
Croatian: • Pas je hladan kad se dotakne (npr. uši).
English: Your veterinarian can best describe these for you.
Croatian: Vaš veterinar će vam ih najbolje opisati.
English: Str. Menuetului nr. 12
Croatian: Menuetului nr. 12
English: 10 DATE OF REVISION OF THE TEXT {MM/YYYY}
Croatian: 10 DATUM REVIZIJE TEKSTA {MM/GGGG}
English: Within 5 minutes, the product dries on the skin.
Croatian: U roku od 5 minuta, proizvod se osuši na koži.
English: Once seated, do not remove the adaptor.
Croatian: Nakon što je sjeo, ne uklanjajte adapter.
English: • Loss of appetite or drinking less water.
Croatian: • Gubitak teka i pijenje manje vode.
English: 3.0 to 4.2 4.3 to 6.1 6.2 to 8.0 8.1 to 9.9 10.0 to 11.7 11.8 to 13.6 13.7 to 15.5 15.6 to 17.4 17.5 to 19.3 19.4 to 21.2 21.3 to 23.1 23.2 to 25.0 25.1 to 26.9 27.0 to 28.8 28.9 to 30.6 30.7 to 32.5 32.6 to 34.4 34.5 to 36.3 36.4 to 38.2 38.3 to 40.1 40.2 to 42.0 42.1 to 43.9 44.0 to 45.8 45.9 to 47.7 47.8 to 49.6 49.7 to 51.4 51.5 to 53.3 53.4 to 55.2 55.3 to 57.0
Croatian: 3,0 do 4,2 4,3 do 6,1 6,2 do 8,0 8,1 do 9,9 10,0 do 11,7 11,8 do 13,6 13,7 do 15,5 15,6 do 17,4 17,5 do 19,3 19,4 do 21,2 21,3 do 23,1 23,2 do 25,0 25,1 do 26,9 27,0 do 28,8 28,9 do 30,6 30,7 do 32,5 32,6 do 34,4 34,5 do 36,3 36,4 do 38,2 38,3 do 40,1 40,2 do 42,0 42,1 do 43,9 44,0 do 45,8 45,9 do 47,7 47,8 do 49,6 49,7 do 51,4 51,5 do 53,3 53,4 do 55,2 55,3 do 57,0
English: Children should not touch the dog before: Date
Croatian: Djeca ne smiju dirati psa prije: Datum
English: ATCvet code: QN02AB03
Croatian: ATCvet kod: QN02AB03
English: Thoroughly clean any contaminated clothing before reuse.
Croatian: Detaljno očistite svu kontaminiranu odjeću prije ponovne upotrebe.
English: Keep this package leaflet in a safe place.
Croatian: Čuvajte ovu uputu na sigurnom mjestu.
English: This dog was treated on: Date
Croatian: Ovaj pas liječen je: Datum
English: Recuvyra like any other medicine may cause adverse reactions.
Croatian: Recuvyra kao i bilo koji drugi lijek može izazvati nuspojave.
English: • Decreased stool production and some temporary weight loss.
Croatian: • Smanjenu proizvodnju stolice i određeni privremeni gubitak težine.
English: Your dog should not be given Recuvyra if it:
Croatian: Vaš pas ne smije primiti Recuvyru ako:
English: After the application site is dry, direct contact to the application site should not pose a risk to adults.
Croatian: Nakon što je mjesto primjene suho, direktni kontakt s mjestom primjene ne bi smio predstavljati rizik za odrasle osobe.
English: It is important that both tips make direct contact with the skin.
Croatian: Važno je da oba vrha dolaze u direktan kontakt s kožom.
English: Your veterinarian will ensure the product is stored correctly and safely for up to 3 years, but the contents of a bottle should be used within 30 days of the first dose being withdrawn.
Croatian: Vaš veterinar osigurat će da se proizvod čuva ispravno i sigurno do 3 godine, ali sadržaj boce potrebno je potrošiti u roku od 30 dana nakon izvlačenja prve doze.
English: Therefore, special precautions should be taken by people whose dogs have been treated with Recuvyra.
Croatian: Prema tome, posebne mjere opreza moraju se uzeti u obzir od strane ljudi čiji psi su liječeni s Recuvyrom.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/127/001
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/127/001
English: Remove the plastic protective cover from the top of the glass vial.
Croatian: Uklonite zaštitni plastični pokrivač s vrha staklene bočice.
English: Sedation may persist beyond 24 hours after application.
Croatian: Sedacija može trajati i dulje od 24 sata nakon aplikacije.
English: Banbury, Oxfordshire, OX16 4RS United Kingdom.
Croatian: Banbury, Oxfordshire, OX16 4RS Ujedinjeno Kraljevstvo.
English: Time to 1.0 ng/ml (hrs)
Croatian: Vrijeme do 1,0 ng/ml (sati)
English: Avoid contact with skin, as Recuvyra can be absorbed by human skin.
Croatian: Izbjegavajte kontakt s kožom jer se Recuvyra može apsorbirati u ljudsku kožu.
English: Your veterinarian received a separate information sheet (summary of product characteristics) with more details on the correct and safe administration of Recuvyra.
Croatian: Vaš veterinar dobio je odvojenu informaciju (Sažetak opisa svojstava) s više detalja o korektnoj i sigurnoj primjeni Recuvyre.