FrancophonIA/ELRC3.0 huggingface dataset:
English: Dark brown, 18 x 10 mm oval, film-coated tablet debossed with “7.5/850” on one side and plain on the other side.
Croatian: Segluromet 7,5 mg/850 mg filmom obložene tablete Tamnosmeđa, ovalna, filmom obložena tableta dimenzija 18 x 10 mm, s utisnutom oznakom „7.5/850“ na jednoj strani i bez oznaka na drugoj strani.
English: Epivir lamivudine
Croatian: Epivir lamivudin
English: The combination also reduced viral loads in all studies after two to four weeks of treatment, but this effect was temporary.
Croatian: Kombinacija je također smanjila virusno opterećenje u svim ispitivanjima nakon dva do četiri tjedna terapije, no ovo je djelovanje bilo privremeno.
English: This can be taken either as a single daily dose or divided into 150 mg twice a day.
Croatian: Ta se doza može uzimati kao jedna dnevna doza ili podijeljena u 150 mg dva puta na dan.
English: The study measured how long the patients lived without their disease getting worse.
Croatian: Ispitivanje je izmjerilo koliko su dugo bolesnici živjeli bez pogoršanja bolesti.
English: It is available as tablets (150 and 300 mg) and as an oral solution (10 mg/ml).
Croatian: Dostupan je u obliku tableta (150 i 300 mg) te kao oralna suspenzija (10 mg/ml).
English: Epivir has also been studied in 615 patients aged between nine months and 15 years.
Croatian: Epivir je također ispitan u 615 bolesnika u dobi između devet mjeseci i 15 godina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Epivir on 8 August 1996.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Epivir na snazi u Europskoj uniji od 8. kolovoza 1996.
English: Similar results were seen in HIV-infected patients aged under 15 years.
Croatian: Slični su rezultati uočeni u bolesnika zaraženih HIV-om mlađih od 15 godina.
English: It does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Croatian: Ne liječi zaraze HIV-om niti AIDS, no može odgoditi oštećenje imunosnog sustava, te razvijanje infekcija i bolesti povezanih s AIDS-om.
English: Patients who cannot swallow tablets should use the oral solution, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it.
Croatian: Bolesnici koji ne mogu progutati tabletu trebaju uzimati oralnu otopinu ili mogu usitniti tablete i dodati ih u male količine hrane ili pića neposredno prije gutanja.
English: In children weighing less than 25 kg the recommended dose depends on their weight.
Croatian: U djece s tjelesnom masom manjom od 25 kg preporučena doza ovisi o njihovoj masi.
English: What measures are being taken to ensure the safe and effective use of Epivir?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Epivir?
English: Epivir has been studied in five main studies involving almost 3,000 adults (aged 18 years or over).
Croatian: Epivir je ispitan u pet glavnih ispitivanja koja su obuhvatila 3 000 odraslih osoba (u dobi od 18 godina ili starijih).
English: This study looked at how many patients had developed an illness associated with AIDS or had died after a year's treatment.
Croatian: Ispitivanje je istražilo koliko je bolesnika razvilo bolest povezanu s AIDS-om ili umrlo nakon godinu dana terapije.
English: CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Croatian: CD4 T-stanice su bijele krvne stanice koje su važne jer pomažu u borbi protiv infekcija, ali HIV ih ubija.
English: Other information about Epivir
Croatian: Ostale informacije o lijeku Epivir
English: The recommended dose of Epivir for adults and children weighing at least 25 kg is 300 mg a day.
Croatian: Preporučena doza lijeka Epivir za odrasle i djecu tjelesne mase veće od 25 kg iznosi 300 mg dnevno.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Epivir.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Epivir.
English: All of the studies found that combinations including Epivir were more effective than the comparator medicines.
Croatian: Svim je ispitivanjima utvrđeno da su kombinacije koje uključuju Epivir bile djelotvornije od komparatorskih lijekova.
English: Treatment with Epivir should be started by a doctor who has experience in the management of HIV infection.
Croatian: Liječenje lijekom Epivir treba započeti liječnik koji ima iskustva u liječenju infekcija HIV-om.
English: In the fifth adult study, adding Epivir to existing treatment reduced the risk of disease progression or death: after a year, 9% of the patients taking Epivir had developed an AIDS-related illness or died (128 out of 1,369), compared with 20% of those taking placebo (95 out of 471).
Croatian: U petom ispitivanju provedenom na odraslim osobama, dodavanje lijeka Epivir postojećoj terapiji smanjilo je rizik od napredovanja bolesti ili smrti: nakon godinu dana 9 % bolesnika (128 od 1 369) koji su uzimali lijek Epivir razvilo je bolesti povezane s AIDS-om ili je umrlo, u usporedbi s 20 % (95 od 471) onih koji su uzimali placebo.
English: Epivir is a medicine containing the active substance lamivudine.
Croatian: Epivir je lijek koji sadrži djelatnu tvar lamivudin.
English: This document is a summary of the European Public Assessment Report (EPAR) for Epivir.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Epivir.
English: The most common side effects with Epivir (seen in between 1 and 10 patients in 100) are diarrhoea, nausea (feeling sick), vomiting, headache, insomnia (difficulty sleeping), cough, nasal symptoms, rash, muscle disorders, arthralgia (joint pain), alopecia (hair loss), fever, abdominal pain (stomach ache) or cramps, malaise (feeling unwell) and fatigue (tiredness).
Croatian: Najčešće nuspojave lijeka Epivir (mogu se javiti u 1 do 10 na 100 bolesnika) su proljev, mučnina (osjećaj slabosti), povraćanje, glavobolja, nesanica (poteškoće sa spavanjem), kašalj, nazalni simptomi, osip, mišićni poremećaji, artralgija (bol u zglobovima), alopecija (gubitak kose), groznica,
English: A risk management plan has been developed to ensure that Epivir is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Epivir.
English: Epivir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Epivir primijenjen u kombinaciji s drugim antivirusnim lijekovima smanjuje količinu HIV-a u krvi i održava je niskom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Epivir, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Epivir nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: In the first four studies in adults, Epivir, taken in combination with zidovudine, increased CD4 cell counts more than the comparator medicines after 24 weeks of treatment.
Croatian: U prva četiri ispitivanja provedena u odraslih osoba, Epivir je, kada se uzimao u kombinaciji sa zidovudinom, povećao broj CD4 stanica više od komparatorskih lijekova nakon 24 tjedna terapije.
English: The studies examined the effects of Epivir on the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count).
Croatian: U ispitivanjima je ispitano djelovanje lijeka Epivir na koncentracije HIV-a u krvi (virusno opterećenje) i broj CD4 T-stanica u krvi (broj CD4 stanica).
English: The CHMP decided that Epivir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Epivir nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The fifth study compared the effects of adding Epivir or placebo (a dummy treatment) to existing treatment for HIV infection in 1,895 adults who had been taking antiviral medicines for at least four weeks.
Croatian: Peto ispitivanje usporedilo je djelovanje dodavanja lijeka Epivir ili placeba (prividnog liječenja) postojećem liječenju infekcije HIV-om u 1 895 odraslih osoba koje su uzimale antivirusne lijekove tijekom najmanje četiri tjedna.
English: Epivir is used in combination with other antiviral medicines to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Epivir je antivirusni lijek koji se koristi u kombinaciji s drugim lijekovima za liječenje bolesnika zaraženih virusom humane imunodeficijencije (HIV), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Why has Epivir been approved?
Croatian: Zašto je Epivir odobren?
English: Four of these studies compared Epivir in combination with zidovudine (another antiviral medicine) to either Epivir or zidovudine alone, or to the combination of Epivir and zalcitabine (another antiviral medicine).
Croatian: Četiri ispitivanja usporedila su Epivir u kombinaciji sa zidovudinom (drugim antivirusnim lijekom) u odnosu na monoterapiju lijekom Epivir ili zidovudinom te kombinaciju lijeka Epivir i zalcitabina (drugog antivirusnog lijeka).
English: What is the risk associated with Epivir?
Croatian: Koji su rizici povezani s lijekom Epivir?
English: The full EPAR for Epivir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Epivir nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Epivir pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The oral solution can be used to achieve the appropriate dose.
Croatian: Za postizanje primjerene doze može se koristiti oralna otopina.
English: What is Epivir?
Croatian: Što je Epivir?
English: What benefit has Epivir shown during the studies?
Croatian: Koje su koristi lijeka Epivir dokazane u ispitivanjima?
English: The study compared the effects of Epivir taken with zidovudine to didanosine (another antiviral medicine) taken alone.
Croatian: Ispitivanje je usporedilo djelovanje lijeka Epivir koji se uzimao sa zidovudinom i monoterapiju didanozinom (drugim antivirusnim lijekom).
English: The active substance in Epivir, lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI).It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell.
Croatian: Djeluje inhibirajući djelovanje reverzne transkriptaze, enzima koji je potreban HIV-u da proizvede genetske upute za stvaranje više virusa nakon što je stanica zaražena.
English: For the full list of all side effects and restrictions with Epivir, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Epivir potražite u uputi o lijeku.
English: What is Epivir used for?
Croatian: Za što se Epivir koristi?
English: How is Epivir used?
Croatian: Kako se Epivir koristi?
English: The dose of Epivir needs to be adjusted in patients who have severe kidney problems.
Croatian: U bolesnika koji imaju ozbiljne probleme s bubrezima dozu lijeka Epivir treba prilagoditi.
English: How has Epivir been studied?
Croatian: Kako je Epivir ispitivan?
English: How does Epivir work?
Croatian: Kako djeluje Epivir?
English: Date of the last renewal:
Croatian: Datum zadnje obnove:
English: The entire content of the bottle should be used immediately after broaching and during the same procedure.
Croatian: Sav sadržaj bočice treba primijeniti odmah nakon otvaranja i u istom postupku.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: a) će primjena proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole ili eradikacije bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: Avoid bubble formation, as this can be irritating at the site of injection.
Croatian: Izbjegavajte stvaranje mjehurića, jer to može biti nadražujuće na mjestu injiciranja.
English: No other adverse reactions except those mentioned in section 4.6 were observed.
Croatian: Nisu primijećene druge nuspojave osim onih već spomenutih u odjeljku 4.6.
English: Store and transport refrigerated (2 °C-8 °C).
Croatian: Čuvati i prevoziti rashlađeno (2 °C - 8 °C).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of the first authorisation: 17/12/2010
Croatian: Datum prvog odobrenja : 17/12/2010
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatne tvari koje se sastoje od tvari biološkog podrijetla, namijenjene za izazivanje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Croatian: Ako se primjenjuje na druge domaće i divlje preživače za koje se smatra da postoji opasnost od zaraze, za te vrste treba primijeniti s oprezom, a preporučuje se i testiranje cjepiva na malom broju životinja prije masovnog cijepljenja.
English: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom
Croatian: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Ujedinjeno Kraljevstvo
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u odjeljku 6.1 Sažetka opisa svojstava su dopuštene tvari za koje, kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010. za koje se MRL ne zahtijeva.
English: PHARMACEUTICAL FORM Homogeneous milky white suspension for injection.
Croatian: OBLIK Homogena mliječno bijela injekcijska suspenzija.
English: Annual.
Croatian: Godišnje jednom.
English: Sheep and cattle
Croatian: Ovce i goveda.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 doses (10 ml)
Croatian: SADRŽAJ, TEŽINA, VOLUMEN ILI BROJ DOZA 10 doza (10 ml).
English: Can be used during pregnancy in ewes.
Croatian: Može se primijeniti tijekom graviditeta u ovaca.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Very rare and transient apathy can be observed after the administration of a double-dose of the vaccine.
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nakon primjene dvostruke doze cjepiva vrlo rijetko je primijećena prolazna apatija.
English: In very rare cases it has been observed a transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Croatian: U vrlo rijetkim slučajevima uočeno je prolazno povišenje tjelesne temperature, obično ne više od 1,1 °C, može se javiti unutar 24 sata nakon cijepljenja.
English: The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
Croatian: Trajnost imuniteta kod goveda i ovaca je 1 godina nakon prvog cijepljenja.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u priloženoj uputi o VMP, molimo da se javite veterinaru.
English: Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code QI04AA02 (sheep) and QI02AA08 (cattle).
Croatian: Farmakoterapijska grupa: cjepivo protiv virusa bolesti plavog jezika, ATCvet kod QI04AA02 (ovce) i QI02AA08 (goveda).
English: Can be used during pregnancy and lactation in cows
Croatian: Može se primijeniti tijekom graviditeta i laktacije u krava.
English: TARGET SPECIES Sheep and cattle.
Croatian: CILJNE VRSTE ŽIVOTINJA Ovce i goveda.
English: 50 doses (50 ml)
Croatian: 50 doza (50 ml).
English: (**) Haemolytic units For the full list of excipients, see section 6.1.
Croatian: Hemolitičke jedinice Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:
Croatian: Injicirajte jednu dozu 1 ml cjepiva supkutano u skladu sa sljedećim rasporedom cijepljenja:
English: No other adverse reactions except those mentioned in section ‘Adverse Reactions' were observed.
Croatian: Nisu primijećene druge nuspojave osim onih već spomenutih u odjeljku ‘Nuspojave'.
English: EXPIRY DATE EXP {month/year} Once broached, use immediately.
Croatian: ROK VALJANOSTI EXP {mjesec/godina} Jednom načeto, upotrijebiti odmah.
English: Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.
Croatian: Početak imuniteta pokazao se 3 tjedna nakon prvog cijepljenja.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: Sukladno članku 71 Direktive 2001/82/EV i Europskog Parlamenta i Vijeća koja je dopunjena, države članice zabranjuju ili mogu zabraniti uvoz, prodaju, opskrbu i/ili primjenu veterinarsko-medicinskog proizvoda na cijelom teritoriju ili na jednom njegovom dijelu ako je utvrđeno da: Sukladno članku 71 Direktive 2001/82/EV i Europskog Parlamenta i Vijeća koja je dopunjena, države članice mogu sukladno nacionalnoj legislativi, zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunološkog veterinarsko-medicinskog proizvoda na cijelom teritoriju ako je utvrđeno da:
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Croatian: U toj kategoriji životinja cjepivo treba primijeniti samo po procjeni odnosa koristi/rizika od strane odgovornog veterinara i/ili nadležnih tijela sukladno važećim odredbama o cijepljenju protiv virusa bolesti plavog jezika (BTV).
English: - Very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: - Vrlo rijetko (manje od 1 na 10.000 životinja životinja, uključujući izolirana izvješća).
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE C. STATEMENT OF THE MRLs
Croatian: ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET B. UVIJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
English: SC Read the package leaflet before use.
Croatian: SC Pročitati uputu o VMP prije primjene.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated.
Croatian: 11. POSEBNI UVIJETI ČUVANJA Čuvati i prevoziti rashlađeno Ne zamrzavati.
English: The vaccine contains inactivated Bluetongue Virus Serotype 1 with aluminium hydroxide and saponin adjuvants.
Croatian: Cjepivo sadrži inaktivirani virus bolesti plavog jezika serotip 1 s aluminijevim hidroksidom i saponinom kao adjuvansima.
English: Al3+ (as hydroxide)
Croatian: (kao hidroksid)
English: Shake gently immediately before use.
Croatian: Neposredno prije primjene lagano protresite.
English: PACKAGE LEAFLET FOR: BTVPUR AlSap 1 suspension for injection for sheep and cattle
Croatian: UPUTA O VMP ZA: BTVPUR AlSap 1 suspenzija za injekciju za ovce i goveda
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 opreza za odlaganje neupotrijebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 10 and 50 ml
Croatian: OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Bočica od 10 ml i 50 ml
English: - Second injection: after 3-4 weeks
Croatian: - Druga injekcija: nakon 3-4 tjedna
English: NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 1 suspension for injection for sheep and cattle.
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA BTVPUR AlSap 1 suspenzija za injekciju za ovce i goveda.
English: - 2nd injection: after 3-4 weeks.
Croatian: - Druga injekcija: nakon 3- 4 tjedna.
English: PACKAGE SIZE 100 doses (100 ml)
Croatian: VELIČINA PAKOVANJA 100 doza (100 ml).
English: In very rare cases it has been observed a small local swelling at the injection site (at most 32 cm² in cattle and 24 cm² in sheep) which becomes residual 35 days later (≤ 1 cm2).
Croatian: U vrlo rijetkim slučajevima uočeno je da se može na mjestu uboda javiti prolazni mali otok (najviše 32 cm² u goveda i 24 cm² u ovaca) koji se povlači za 35 dana (≤ 1 cm
English: Inactivated BTV1 ..................................................................................................... ≥ 1.9 log10 pixels* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet
Croatian: Inaktivirani BTV1 ................................................................................................... ≥1,9 log10piksela* Aluminij hidroksid, saponin, q.s. 1 doza (*)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/112/001
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/10/112/001
English: Inactivated Bluetongue Virus Serotype 1 ................................................................. ≥ 1.9 log10 pixels* (*) Antigen content (VP2 protein) by immuno-assay Adjuvants: .
Croatian: Inaktivirani Virus protiv bolesti plavog jezika Serotip 1 ....................................... ≥1,9 log10piksela * (*) Antigen sadržaj (VP2 proteina) po imuno-testu
English: Any person intending to manufacture, import, possess, sell, supply and/or use BTVPUR AlSap 1 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Croatian: Tko namjerava proizvoditi,uvesti, posjedovati, prodavati, opskrbljivati i/ili primjenjivati BTVPUR AlSap 1 mora konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju prije proizvodnje, uvoza, posjedovanja, prodaje, opskrbe i/ili primjene.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, AKO JE PRIMJENJIVO