FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.
Croatian: Jedna filmom obložena tableta sadrži 15 mg memantinklorida što odgovara 12,46 mg memantina.
English: Each film-coated tablet contains 1.89 mg lactose monohydrate.
Croatian: Nemdatine 20 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 1,89 mg laktoze hidrata.
English: Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
Croatian: Jedna filmom obložena tableta sadrži 5 mg memantinklorida što odgovara 4,15 mg memantina.
English: Orange, oval shaped, biconvex film-coated tablets, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Croatian: Narančasta, bikonveksna filmom obložena tableta, ovalnog oblika, veličine 11,4 mm x 6,4 mm i s ugraviranom oznakom „M15” na jednoj strani.
English: Hepatobiliary disorders
Croatian: TVARI memantinklorid
English: Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg film-coated tablets memantine hydrochloride
Croatian: Nemdatine 15 mg filmom obložene tablete Nemdatine 20 mg filmom obložene tablete memantinklorid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/001 42 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/001 42 filmom obložene tablete EU/1/13/824/002 98 filmom obloženih tableta
English: Each film-coated tablet contains 1.42 mg lactose monohydrate.
Croatian: Nemdatine 15 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 1,42 mg laktoze hidrata.
English: White, capsule-shaped, biconvex film-coated tablets, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.
Croatian: Bijela, bikonveksna filmom obložena tableta, u obliku kapsule, veličine 9,8 mm x 4,9 mm, s razdjelnom crtom i ugraviranom oznakom „M 10” na strani s razdjelnom crtom.
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 10 mg tablets memantine hydrochloride
Croatian: NAZIV LIJEKA Nemdatine 10 mg tablete memantinklorid
English: Pack sizes Blister packs: 42 and 98 film-coated tablets.
Croatian: Veličine pakiranja Pakiranja s blisterima: 42 i 98 filmom obloženih tableta.
English: Nemdatine 20 mg film-coated tablets memantine hydrochloride
Croatian: Nemdatine 20 mg filmom obložene tablete memantinklorid
English: White, oval shaped, biconvex film-coated tablets, 8 mm x 4.5 mm in size, with the marking “M5”
Croatian: Bijela, bikonveksna filmom obložena tableta, ovalnog oblika, veličine 8 mm x 4,5 mm i s ugraviranom oznakom „M5” na jednoj strani.
English: Nemdatine 5 mg film-coated tablets
Croatian: Nemdatine 5 mg filmom obložene tablete
English: 10 mg tablet
Croatian: 2. tjedan tableta od 10 mg
English: Each film-coated tablet contains 0.95 mg lactose monohydrate.
Croatian: Nemdatine 10 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 0,95 mg laktoze hidrata.
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 15 mg tablets memantine hydrochloride
Croatian: NAZIV LIJEKA Nemdatine 15 mg tablete memantinklorid
English: Nemdatine 5 mg film-coated tablets Nemdatine 10 mg film-coated tablets Nemdatine 15 mg film-coated tablets Nemdatine 20 mg film-coated tablets
Croatian: 7 Nemdatine 5 mg filmom obloženih tableta 7 Nemdatine 10 mg filmom obloženih tableta 7 Nemdatine 15 mg filmom obloženih tableta 7 Nemdatine 20 mg filmom obloženih tableta
English: 5 mg tablet
Croatian: 1. tjedan tableta od 5 mg
English: Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: Week 1: 7 film-coated tablets of Nemdatine 5 mg
Croatian: Jedno pakiranje s 28 filmom obloženih tableta za plan liječenja za 4 tjedna sadrži:
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 5 mg tablets memantine hydrochloride
Croatian: NAZIV LIJEKA Nemdatine 5 mg tablete memantinklorid
English: Nemdatine 10 mg film-coated tablets memantine hydrochloride
Croatian: Nemdatine 10 mg filmom obložene tablete memantinklorid
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
Croatian: BLISTER ZA TABLETE - PAKIRANJE ZA POČETAK
English: White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in size, with the marking “M5”
Croatian: Bijele, bikonveksne, ovalnog oblika, veličine 8 mm x 4,5 mm i s ugraviranom oznakom „M5” na jednoj strani.
English: Each film-coated tablet contains 0.47 mg lactose monohydrate.
Croatian: Nemdatine 5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 0,47 mg laktoze hidrata.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/021
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/021
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/018
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/018
English: Nemdatine 15 mg film-coated tablets memantine hydrochloride
Croatian: Nemdatine 15 mg filmom obložene tablete memantinklorid
English: Nemdatine 5 mg film-coated tablets memantine hydrochloride
Croatian: Nemdatine 5 mg filmom obložene tablete memantinklorid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/019
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/019
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/020
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/020
English: Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Croatian: Jedna tableta sadrži 10 mg memantinklorida, što odgovara 8,31 mg memantina.
English: In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Croatian: (konfuziju, omamljenost, somnolenciju, vrtoglavicu, agitaciju, agresiju, halucinacije i poremećaj hoda)
English: Aurobindo Pharma B.V. Tel: +31 355429933
Croatian: Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
English: Hypromellose 6cP Titanium dioxide (E171) Lactose monohydrate Macrogol 3350
Croatian: Ovojnica tablete za 5 mg i 10 mg filmom obložene tablete hipromeloza 6cP titanijev dioksid (E171) laktoza hidrat makrogol 3350 triacetin
English: Nemdatine 5 mg film-coated tablets:
Croatian: Veličine pakiranja Nemdatine 5 mg filmom obložene tablete:
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 20 mg film-coated tablets memantine hydrochloride
Croatian: Uputa o lijeku: Informacija za bolesnika Nemdatine 20 mg filmom obložene tablete memantinklorid
English: In the event of such reactions, treatment may be needed.
Croatian: U slučaju takvih reakcija, može biti potrebno liječenje.
English: Date of last renewal: 13/12/2013
Croatian: Datum posljednjeg produženja:13/12/2013.
English: The NETHERLANDS
Croatian: Nizozemska
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Croatian: Ako bol traje više od 12 sati nakon liječničkog pregleda, potražite ponovo savjet liječnika.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Croatian: Rok valjanosti veterinarsko medicinskog proizvoda kao pakiranog za prodaju: 3 godine.
English: This veterinary medicinal product contains mineral oil.
Croatian: Veterinarsko medicinski proizvod sadrži mineralno ulje.
English: 30938 Burgwedel GERMANY
Croatian: 30938 Burgwedel Njemačka
English: In such cases it is advised to perform PCV2 serology, using suitable diagnostics, to select the most appropriate vaccination schedule.
Croatian: U takvim slučajevima savjetuje se obavljanje PCV2 serolologije, koristeći prikladnu dijagnostiku da se odabere najprikladniji raspored cijepljenja.
English: These reactions resolve spontaneously over a period of approximately 14-21 days without any major consequence on the general health status of the animals.
Croatian: 14 do 21 dan bez većih posljedica na opće zdravstveno stanje životinja.
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 or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari ( uključujući i adjuvanse) navedeni u odjeljku 6.1 SPC-a su ili odobrene tvari za koje je u tablici: 1 Dodataka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se koriste u ovom veterinarsko medicinskom proizvodu.
English: Vials are closed with a nitryl rubber stopper and a coded aluminium cap.
Croatian: Bočice su zatvorene s nitril gumenim čepom i kodiranom aluminijskom kapicom.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions 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) - rijetke (više od 1, ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve)
English: 4.8 Interaction with other medicinal products and other forms of interaction
Croatian: 4.8 Interakcija s drugim lijekovima i drugi oblici interakcija
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Nema dostupnih informacija o neškodljivosti i djelotvornosti ovog cjepiva kada se koristi s bilo kojim drugim veterinarsko medicinskim proizvodom.
English: In post marketing experience:
Croatian: Iskustva nakon stavljanja u promet:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom proizvodu dostupne su na internetskoj stranici Europske agencije za lijekove (http://www.ema.europa.eu/).
English: In very rare cases anaphylactic-type reactions can occur, which may be life-threatening.
Croatian: U vrlo rijetkim slučajevima mogu se pojaviti anafilaktičke reakcije koje mogu biti opasne po život.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Croatian: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
English: Administer one dose of 2 ml by intramuscular injection in the neck, in the area behind the ear, according to the following schedule:
Croatian: Primijeniti jednu dozu od 2 ml intramuskularnom injekcijom u vrat, u područje iza uha, u skladu sa sljedećim uputama:
English: EU/2/08/091/003 100 ml EU/2/08/091/004 200 ml EU/2/08/091/005 500 ml EU/2/08/091/006 10 x 20 ml EU/2/08/091/007 10 x 50 ml EU/2/08/091/008 10 x 100 ml EU/2/08/091/009 10 x 200 ml EU/2/08/091/010 10 x 500 ml
Croatian: EU/2/08/091/001 20 ml EU/2/08/091/002 50 ml EU/2/08/091/003 100 ml EU/2/08/091/004 200 ml EU/2/08/091/005 500 ml EU/2/08/091/006 10 x 20 ml EU/2/08/091/007 10 x 50 ml EU/2/08/091/008 10 x 100 ml
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: Djelatna tvar se sastoji od tvari biološkog podrijetla, namijenjena je za izazivanje aktivnog imuniteta i na njih se ne primjenjuju odredbe Uredbe (EZ) br. 470/2009.
English: In case of doubt, apply the two shot vaccination schedule.
Croatian: U slučaju sumnje koristiti raspored od 2 cijepljenja.
English: SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous.
Croatian: POSEBNO(A) UPOZORENJE(A), UKOLIKO JE POTREBNO Slučajno samoinjiciranje je opasno.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Croatian: ZABRANA PRODAJE, NABAVE I/ILI UPOTREBE
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International BV
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: Intervet International BV
English: Before using the vaccine allow it to reach room temperature (15-25 °C) and shake well before use.
Croatian: Prije primjene cjepivo zagrijati na sobnu temperaturu (15-25°C), a potom dobro protresti.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: Svaki neiskorišteni veterinarsko-medicinski proizvod ili otpadni materijal koji proizlazi iz takvog veterinarsko - medicinskog proizvoda treba zbrinuti u skladu s lokalnim propisima.
English: Transient local reactions at the injection site were very commonly observed after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm).
Croatian: Uočene su prolazne lokalne reakcije na mjestu ubrizgavanja nakon cijepljenja, u obliku tvrde, tople i ponekad bolne otekline (promjera do 10 cm).
English: A transient increase in body temperature, normally not exceeding 1 °C, was very commonly observed until 2 days after vaccination.
Croatian: Prolazan porast tjelesne temperature, obično za 1ºC, uočen je vrlo često 2 dana nakon cijepljenja.
English: When it is expected that higher levels of maternally derived antibodies against PCV2 are present, the following schedule of two vaccinations is advised: the first injection (2 ml) can be given from an age of 3-5 days, the second injection (2 ml) 2-3 weeks later.
Croatian: Kad se očekuje prisutnost više razine materalnih antitijela protiv PCV2, savjetuje se slijedeća shema od dva cijepljenja: Prva injekcija (2 ml) može se dati u dobi od 3 - 5 dana, a sljedeća (2 ml) 2 - 3 tjedna kasnije.
English: Avoid use of vaccination equipment with rubber parts.
Croatian: Izbjegavati uporabu opreme za cijepljenje koja sadrži gumene dijelove.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Croatian: Odluka za korištenje ovog cjepiva prije ili nakon bilo kojeg drugog veterinarsko medicinskog proizvoda mora biti donijeta od slučaja do slučaja.
English: High levels of MDA may be expected when sows/gilts are vaccinated against PCV2 virus or when sows/gilts have recently been exposed to high levels of PCV2 virus.
Croatian: Visoke razine materalnih antitijela (MDA) mogu biti očekivane kad su krmače/nazimice cijepljene protiv PCV2 virusa ili kad su krmače/nazimice nedavno bile izložene visokim razinama PCV2 virusa.
English: Dl-α-tocopheryl acetate
Croatian: D1-α-tokoferil acetat
English: Name and address of the manufacturers of the biological active substance
Croatian: Naziv i adresa proizvođača biološki djelatne tvari.
English: Do not use this veterinary medicinal product after the expiry date (EXP) which is stated on the carton and the vial.
Croatian: Ne upotrebljavajte ovaj veterinarsko medicinski proizvod nakon datuma isteka valjanosti (EXP)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials {20 and 50 ml}
Croatian: OSNOVNI DIJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Bočica {20 i 50 ml }
English: Immediate systemic hypersensitivity-like reactions were commonly observed after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment.
Croatian: Nakon cijepljenja obično se uoče su brze sustavne reakcije, nalik na reakcije preosjetljivosti, , koje rezultiraju malim neurološkim simptomima kao što su podrhtavanje i/ili uzbuđenje, koji mogu prestati u roku od par minuta bez liječenja.
English: 6.5 Nature and composition of immediate packaging
Croatian: 6.5 Osobine i sastav pakovanja
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/01/2009.
Croatian: Datum prvog odobrenja: 12/01/2009.
English: In individual animals, an increase of rectal temperature of 2.5 °C lasting less than 24 hours was uncommonly observed.
Croatian: U individualnim slučajevima rijetko može doći do povećanja rektalne temperature od 2,5 ºC, u trajanju od 24 sata.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza od 2 ml cjepiva sadrži:
English: Before using the vaccine, allow it to reach room temperature and shake well before use.
Croatian: Prije primjene cjepivo treba zagrijati na sobnu temperaturu, a potom dobro protresti.
English: Following the administration of a double dose of vaccine no side effects other than those described under “adverse reactions” have been observed.
Croatian: Primjenom duple doze cjepiva, nisu primijećene nuspojave osim onih opisanih pod „Nuspojave“.
English: No data are available on the use of the vaccine in breeding boars.
Croatian: Nema dostupnih podataka primjene cjepiva kod rasplodnih nerasta.
English: IM Shake well before use.
Croatian: Prije primjene dobro promućkati.
English: For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period.
Croatian: Za aktivnu imunizaciju svinja za smanjenje količine virusa u krvi i limfnom tkivu, te smanjenje smrtnost i gubitka težine, povezane s PCV2 infekcijom koja se javlja tijekom tova.
English: Opalescent white, with brown resuspendable sediment.
Croatian: Opalescentno bijela, sa smeđim talogom koji se lako ponovno suspendira.
English: Pack sizes: cardboard boxes with either 1 or 10 vials of 20, 50, 100, 200 or 500 ml (10, 25, 50, 100 or 250 doses).
Croatian: Pakiranje: kartonska kutija s 1 ili 10 PET bočica od 20, 50, 100, 200 ili 500 ml (10, 25, 50, 100 ili 250 doza).
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere opreza pri odlaganju neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala koji proizlaze iz takvih korištenja takvih proizvoda
English: Zero days.
Croatian: Karencija: 0 dana.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/091/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/091/001- 010
English: From the data provided, it can be concluded that a single dose regimen of vaccination breaks through up to medium levels and double dose regimen through medium to high levels of maternally derived antibodies in piglets.
Croatian: Na temelju dobivenih podataka može se zaključiti da je pri cijepljenju jednom dozom cjepiva razina materalnih protutijela u prasadi srednje razine, a pri shemi cijepljenja s dvostrukom dozom razina materalnih protutijela kod prasadi je srednja do visoka.
English: Vaccine to stimulate active immunity against porcine circovirus type 2.
Croatian: Cjepivo za poticanje aktivnog imuniteta protiv cirovirusa svinja, tipa 2.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2 °C - 8 °C).
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati u hladnjaku (2 - 8 ºC).
English: Shelf life after first opening the immediate packaging: 8 hours.
Croatian: Rok valjanosti nakon prvog otvaranja unutarnjeg pakovanja: 8 sati.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Croatian: Posebna upozorenja za osobu koja primjenjuje veterinarsko medicinski proizvod na životinjama:
English: In some piglets depression and a reduced feed intake for up to 5 days were uncommonly observed.
Croatian: U rijetkim slučajevima uočena je potištenost pojedine prasadi, do 5 dana te smanjen unos hrane.
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated porcine circovirus vaccine.
Croatian: Farmakoterapijska skupina: inaktivirano svinjsko cirkovirus cjepivo.
English: MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJI ODOBRENJA ZA STAVLJANJE U PROMET
English: Do not use during pregnancy and lactation.
Croatian: Cjepivo ne primjenjivati tijekom graviditeta i laktacije.
English: Shelf-life after first opening the container: 8 hours.
Croatian: Rok valjanosti nakon prvog otvaranja: 8 sati.
English: Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and, in rare cases, could result in the loss of the affected finger if prompt medical attention is not given.
Croatian: Slučajno injiciranje/samoinjiciranje može uzrokovati jaku bol i oteklinu, posebice ako je ubrizgan u zglob na prstu, i u rijetkim slučajevima, ako se trenutno nije poduzeta liječnička pomoć, može doći i do gubitka prsta.
English: Cardboard boxes with either 1 or 10 PET vials of 20, 50, 100, 200 or 500 ml.
Croatian: Kartonske kutije s 1 ili 10 PET bočica od 20, 50, 100, 200 ili 500 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes {20, 50, 100, 200 and 500 ml}
Croatian: PODACI NA VANJSKOM PAKOVANJU Kartonska kutija { 20, 50, 100, 200 i 500 ml}
English: To the user:
Croatian: Za korisnika
English: If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
Croatian: Ako dođe do slučajnog injiciranja ovim pripravkom, čak i kod male injicirane količine treba odmah potražiti medicinski savjet, te ponijeti uputu sa sobom.
English: Avoid introduction of contamination.
Croatian: Obratiti pozornost da se pripravak ne kontaminira.
English: 4.2 Indications for use, specifying the target species For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period.
Croatian: Za aktivnu imunizaciju svinja, za smanjenje količine virusa u krvi i limfnom tkivu, te smanjenje smrtnost i gubitka težine, povezane s PCV2 infekcijom koja se javlja tijekom tova.
English: Pregnancy and lactation: Do not use during pregnancy and lactation.
Croatian: Cjepivo se ne smije primjenjivati tijekom gravidnosti i laktacije.
English: EXPIRY DATE EXP {month/year} Once broached, use within 8 hours.
Croatian: Nakon otvaranja, iskoristiti unutar 8 sati.
English: Water for injections
Croatian: Simetikon Voda za injekcije
English: In the case of low to medium levels of maternally derived antibodies against PCV2 a single vaccination (2 ml) to pigs from an age of 3 weeks onwards is advised.
Croatian: U slučaju niske do srednje razine materalnih antitijela protiv PCV2 savjetuje se jedno cijepljenje (2
English: EU/2/08/091/002
Croatian: EU/2/08/091/009 10 x 200 ml
English: Following the administration of a double dose of vaccine no side effects other than those described in section 4.6 have been observed.
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidot), ako je nužno Primjena duple doze cjepiva, nema nikakvih drugih učinaka osim onih koji su opisani u poglavlju 4.6.
English: Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.
Croatian: Cjepivo može, neposredno nakon aplikacije, uzrokovati prolazno smanjenje prirasta.
English: 25 mg dl-α-tocopheryl acetate
Croatian: 25 mg dl-α-tokoferil acetata 346 mg rijetko tekućeg parafina
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNE(IH) TVARI ODGOVORNI ZA PUŠTANJE SERIJE U PROMET