natgillin/translations-raw huggingface dataset:
Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.
Nemdatine 10 mg filmom obložene tablete (tablete) su bijele, u obliku kapsule, bikonveksne, veličine 9,8 mm x 4,9 mm, s razdjelnom crtom i ugraviranom oznakom „M 10” na strani s razdjelnom crtom.
Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.
Ovojnica tablete (Opadry II White 33G28435): hipromeloza 6cP, titanijev dioksid (E171), laktoza hidrat, makrogol 3350 i triacetin.
In patients with moderate renal impairment (creatinine clearance 3049 ml/min) daily dose should be 10 mg per day.
30-49 ml/min) dnevna doza bi trebala biti 10 mg na dan.
<[For HDPE bottle only:]>
<[Samo za HDPE bocu:]> Iskoristiti unutar 100 dana od otvaranja.
Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side.
Nemdatine 5 mg filmom obložene tablete (tablete) su bijele, ovalnog oblika, bikonveksne, veličine 8 mm x 4,5 mm i s ugraviranom oznakom „M5” na jednoj strani.
Tablet coat (Opadry II Orange 33G230001): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide yellow, red and black (E172).
Ovojnica tablete (Opadry II Orange 33G230001): hipromeloza 6cP, titanijev dioksid (E171), laktoza hidrat, makrogol 3350, triacetin i željezov oksid, žuti, crveni i crni (E172).
Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Nemdatine 15 mg filmom obložene tablete (tablete) su narančaste, ovalnog oblika, bikonveksne, veličine 11,4 mm x 6,4 mm i s ugraviranom oznakom „M15” na jednoj strani.
One 5 mg tablet
1. tjedan jedna tableta od 5 mg
Nemdatine 20 mg film-coated tablets:
Nemdatine 20 mg filmom obložene tablete:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf.
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Actavis Group PTC ehf.
Dizziness
Nemdatine.
Nemdatine 10 mg film-coated tablets:
Nemdatine 10 mg filmom obložene tablete:
The patient should take one 5 mg film-coated tablet per day (white, oval-shaped) for 7 days.
Bolesnik treba uzimati jednu filmom obloženu tabletu od 5 mg dnevno (bijelu, ovalnog oblika) tijekom 7 dana.
Nemdatine 20 mg Week 4
Nemdatine 10 mg 2. tjedan
Dark pink, oval shaped, biconvex film-coated tablets, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.
Tamno ružičasta, bikonveksna filmom obložena tableta, ovalnog oblika, veličine 12,6 mm x 7 mm i s ugraviranom oznakom „M20” na jednoj strani.
Breast-feeding Women taking Nemdatine should not breast-feed.
Nemdatine ne bi trebale dojiti.
Tablet coat (Opadry II Pink 33G240000): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide red and yellow (E172).
Ovojnica tablete (Opadry II Pink 33G240000): hipromeloza 6cP, titanijev dioksid (E171), laktoza hidrat, makrogol 3350, triacetin i željezov oksid, crveni i žuti (E172).
15 mg tablet Week 4 and beyond 20 mg tablets once a day
3. tjedan tableta od 15 mg 4. tjedan i nadalje tableta od 20 mg jedanput na dan
One 15 mg tablet Week 4 and beyond One 20 mg tablet once a day
3. tjedan jedna tableta od 15 mg 4. tjedan i nadalje jedna tableta od 20 mg jedanput na dan
Blister packs: 42 and 98 film-coated tablets.
Pakiranja s blisterima: 42 i 98 filmom obloženih tableta.
Nemdatine 20 mg film-coated tablets
Nemdatine 20 mg filmom obložene tablete
Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland
Reykjavíkurvegi 76 78 220 Hafnarfjörður Island
Nemdatine 10 mg film-coated tablets
Nemdatine 10 mg filmom obložene tablete
Pack sizes Blister packs: 7, 42 and 98 film-coated tablets.
Veličine pakiranja Pakiranja s blisterima: 7, 42 i 98 filmom obloženih tableta.
shortness of breath, high blood pressure and drug hypersensitivity
glavobolja, pospanost, zatvor, povišeni rezultati testova jetrene funkcije, omaglica, poremećaji ravnoteže, nedostatak zraka, visoki krvni tlak i preosjetljivost na lijek
In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11 − 23) were randomised.
U drugom monoterapijskom ispitivanju blage do umjerene Alzheimerove bolesti randomizirano je ukupno 470
One 10 mg tablet
2. tjedan jedna tableta od 10 mg
The patient should take one 15 mg film-coated tablet per day (orange, oval shaped) for 7 days.
Bolesnik treba uzimati jednu filmom obloženu tabletu od 15 mg dnevno (narančastu, ovalnog oblika) tijekom 7 dana.
Nemdatine 10 mg and 20 mg film-coated tablets:
Nemdatine 10 mg i 20 mg filmom obložene tablete: HDPE boca.
NAME OF THE MEDICINAL PRODUCT Nemdatine 20 mg tablets memantine hydrochloride
NAZIV LIJEKA Nemdatine 20 mg tablete memantinklorid
Week 1: Take one tablet daily of Nemdatine 5 mg. Week 2: Take one tablet daily of Nemdatine 10 mg. Week 3: Take one tablet daily of Nemdatine 15 mg. Week 4: Take one tablet daily of Nemdatine 20 mg.
1. tjedan: 7 Nemdatine 5 mg filmom obloženih tableta 2. tjedan: 7 Nemdatine 10 mg filmom obloženih tableta 3. tjedan: 7 Nemdatine 15 mg filmom obloženih tableta 4. tjedan: 7 Nemdatine 20 mg filmom obloženih tableta
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Jedna filmom obložena tableta sadrži 20 mg memantinklorida što odgovara 16,62 mg memantina.
PHARMACEUTICAL FORM AND CONTENTS 42 film-coated tablets
OBLIK I SADRŽAJ 42 filmom obložene tablete 98 filmom obloženih tableta
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Jedna filmom obložena tableta sadrži 10 mg memantinklorida što odgovara 8,31 mg memantina.
Orange, oval shaped, biconvex film-coated tablet, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Narančaste, bikonveksne, ovalnog oblika, veličine 11,4 mm x 6,4 mm i s ugraviranom oznakom „M15” na jednoj strani.
Nemdatine 15 mg film-coated tablets
Nemdatine 15 mg filmom obložene tablete
White, capsule-shaped, biconvex film-coated tablet, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.
Bijele, bikonveksne, u obliku kapsule, veličine 9,8 mm x 4,9 mm, s razdjelnom crtom i ugraviranom oznakom „M 10” na strani s razdjelnom crtom.
Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.
Jedna filmom obložena tableta sadrži 15 mg memantinklorida što odgovara 12,46 mg memantina.
Each film-coated tablet contains 1.89 mg lactose monohydrate.
Nemdatine 20 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 1,89 mg laktoze hidrata.
Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
Jedna filmom obložena tableta sadrži 5 mg memantinklorida što odgovara 4,15 mg memantina.
Orange, oval shaped, biconvex film-coated tablets, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Narančasta, bikonveksna filmom obložena tableta, ovalnog oblika, veličine 11,4 mm x 6,4 mm i s ugraviranom oznakom „M15” na jednoj strani.
Hepatobiliary disorders
TVARI memantinklorid
Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg film-coated tablets memantine hydrochloride
Nemdatine 15 mg filmom obložene tablete Nemdatine 20 mg filmom obložene tablete memantinklorid
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/001 42 film-coated tablets
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
Each film-coated tablet contains 1.42 mg lactose monohydrate.
Nemdatine 15 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 1,42 mg laktoze hidrata.
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.
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.
NAME OF THE MEDICINAL PRODUCT Nemdatine 10 mg tablets memantine hydrochloride
NAZIV LIJEKA Nemdatine 10 mg tablete memantinklorid
Pack sizes Blister packs: 42 and 98 film-coated tablets.
Veličine pakiranja Pakiranja s blisterima: 42 i 98 filmom obloženih tableta.
Nemdatine 20 mg film-coated tablets memantine hydrochloride
Nemdatine 20 mg filmom obložene tablete memantinklorid
White, oval shaped, biconvex film-coated tablets, 8 mm x 4.5 mm in size, with the marking “M5”
Bijela, bikonveksna filmom obložena tableta, ovalnog oblika, veličine 8 mm x 4,5 mm i s ugraviranom oznakom „M5” na jednoj strani.
Nemdatine 5 mg film-coated tablets
Nemdatine 5 mg filmom obložene tablete
10 mg tablet
2. tjedan tableta od 10 mg
Each film-coated tablet contains 0.95 mg lactose monohydrate.
Nemdatine 10 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 0,95 mg laktoze hidrata.
NAME OF THE MEDICINAL PRODUCT Nemdatine 15 mg tablets memantine hydrochloride
NAZIV LIJEKA Nemdatine 15 mg tablete memantinklorid
Nemdatine 5 mg film-coated tablets Nemdatine 10 mg film-coated tablets Nemdatine 15 mg film-coated tablets Nemdatine 20 mg film-coated tablets
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
5 mg tablet
1. tjedan tableta od 5 mg
Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: Week 1: 7 film-coated tablets of Nemdatine 5 mg
Jedno pakiranje s 28 filmom obloženih tableta za plan liječenja za 4 tjedna sadrži:
NAME OF THE MEDICINAL PRODUCT Nemdatine 5 mg tablets memantine hydrochloride
NAZIV LIJEKA Nemdatine 5 mg tablete memantinklorid
Nemdatine 10 mg film-coated tablets memantine hydrochloride
Nemdatine 10 mg filmom obložene tablete memantinklorid
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
BLISTER ZA TABLETE - PAKIRANJE ZA POČETAK
White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in size, with the marking “M5”
Bijele, bikonveksne, ovalnog oblika, veličine 8 mm x 4,5 mm i s ugraviranom oznakom „M5” na jednoj strani.
Each film-coated tablet contains 0.47 mg lactose monohydrate.
Nemdatine 5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 0,47 mg laktoze hidrata.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/021
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/021
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/018
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/018
Nemdatine 15 mg film-coated tablets memantine hydrochloride
Nemdatine 15 mg filmom obložene tablete memantinklorid
Nemdatine 5 mg film-coated tablets memantine hydrochloride
Nemdatine 5 mg filmom obložene tablete memantinklorid
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/019
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/019
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/020
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/020
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Jedna tableta sadrži 10 mg memantinklorida, što odgovara 8,31 mg memantina.
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).
(konfuziju, omamljenost, somnolenciju, vrtoglavicu, agitaciju, agresiju, halucinacije i poremećaj hoda)
Aurobindo Pharma B.V. Tel: +31 355429933
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Hypromellose 6cP Titanium dioxide (E171) Lactose monohydrate Macrogol 3350
Ovojnica tablete za 5 mg i 10 mg filmom obložene tablete hipromeloza 6cP titanijev dioksid (E171) laktoza hidrat makrogol 3350 triacetin
Nemdatine 5 mg film-coated tablets:
Veličine pakiranja Nemdatine 5 mg filmom obložene tablete:
NAME OF THE MEDICINAL PRODUCT Nemdatine 20 mg film-coated tablets memantine hydrochloride
Uputa o lijeku: Informacija za bolesnika Nemdatine 20 mg filmom obložene tablete memantinklorid
In the event of such reactions, treatment may be needed.
U slučaju takvih reakcija, može biti potrebno liječenje.
Date of last renewal: 13/12/2013
Datum posljednjeg produženja:13/12/2013.
The NETHERLANDS
Nizozemska
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Ako bol traje više od 12 sati nakon liječničkog pregleda, potražite ponovo savjet liječnika.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Rok valjanosti veterinarsko medicinskog proizvoda kao pakiranog za prodaju: 3 godine.
This veterinary medicinal product contains mineral oil.
Veterinarsko medicinski proizvod sadrži mineralno ulje.
30938 Burgwedel GERMANY
30938 Burgwedel Njemačka
In such cases it is advised to perform PCV2 serology, using suitable diagnostics, to select the most appropriate vaccination schedule.
U takvim slučajevima savjetuje se obavljanje PCV2 serolologije, koristeći prikladnu dijagnostiku da se odabere najprikladniji raspored cijepljenja.
These reactions resolve spontaneously over a period of approximately 14-21 days without any major consequence on the general health status of the animals.
14 do 21 dan bez većih posljedica na opće zdravstveno stanje životinja.
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.
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.
Vials are closed with a nitryl rubber stopper and a coded aluminium cap.
Bočice su zatvorene s nitril gumenim čepom i kodiranom aluminijskom kapicom.
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).
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)
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Interakcija s drugim lijekovima i drugi oblici interakcija
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
SADRŽAJ PO TEŽINI, VOLUMENU
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Nema dostupnih informacija o neškodljivosti i djelotvornosti ovog cjepiva kada se koristi s bilo kojim drugim veterinarsko medicinskim proizvodom.
In post marketing experience:
Iskustva nakon stavljanja u promet:
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Detaljne informacije o ovom proizvodu dostupne su na internetskoj stranici Europske agencije za lijekove (http://www.ema.europa.eu/).
In very rare cases anaphylactic-type reactions can occur, which may be life-threatening.
U vrlo rijetkim slučajevima mogu se pojaviti anafilaktičke reakcije koje mogu biti opasne po život.
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
Administer one dose of 2 ml by intramuscular injection in the neck, in the area behind the ear, according to the following schedule:
Primijeniti jednu dozu od 2 ml intramuskularnom injekcijom u vrat, u područje iza uha, u skladu sa sljedećim uputama:
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
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
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.
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.
In case of doubt, apply the two shot vaccination schedule.
U slučaju sumnje koristiti raspored od 2 cijepljenja.
SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous.
POSEBNO(A) UPOZORENJE(A), UKOLIKO JE POTREBNO Slučajno samoinjiciranje je opasno.
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
ZABRANA PRODAJE, NABAVE I/ILI UPOTREBE
Marketing authorisation holder and manufacturer responsible for batch release: Intervet International BV
Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: Intervet International BV
Before using the vaccine allow it to reach room temperature (15-25 °C) and shake well before use.
Prije primjene cjepivo zagrijati na sobnu temperaturu (15-25°C), a potom dobro protresti.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Svaki neiskorišteni veterinarsko-medicinski proizvod ili otpadni materijal koji proizlazi iz takvog veterinarsko - medicinskog proizvoda treba zbrinuti u skladu s lokalnim propisima.
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).
Uočene su prolazne lokalne reakcije na mjestu ubrizgavanja nakon cijepljenja, u obliku tvrde, tople i ponekad bolne otekline (promjera do 10 cm).
A transient increase in body temperature, normally not exceeding 1 °C, was very commonly observed until 2 days after vaccination.
Prolazan porast tjelesne temperature, obično za 1ºC, uočen je vrlo često 2 dana nakon cijepljenja.
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.
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.
Avoid use of vaccination equipment with rubber parts.
Izbjegavati uporabu opreme za cijepljenje koja sadrži gumene dijelove.
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.
Odluka za korištenje ovog cjepiva prije ili nakon bilo kojeg drugog veterinarsko medicinskog proizvoda mora biti donijeta od slučaja do slučaja.
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.
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.
Dl-α-tocopheryl acetate
D1-α-tokoferil acetat
Name and address of the manufacturers of the biological active substance
Naziv i adresa proizvođača biološki djelatne tvari.
Do not use this veterinary medicinal product after the expiry date (EXP) which is stated on the carton and the vial.
Ne upotrebljavajte ovaj veterinarsko medicinski proizvod nakon datuma isteka valjanosti (EXP)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials {20 and 50 ml}
OSNOVNI DIJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Bočica {20 i 50 ml }
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.
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.
6.5 Nature and composition of immediate packaging
6.5 Osobine i sastav pakovanja
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/01/2009.
Datum prvog odobrenja: 12/01/2009.
In individual animals, an increase of rectal temperature of 2.5 °C lasting less than 24 hours was uncommonly observed.
U individualnim slučajevima rijetko može doći do povećanja rektalne temperature od 2,5 ºC, u trajanju od 24 sata.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains:
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza od 2 ml cjepiva sadrži:
Before using the vaccine, allow it to reach room temperature and shake well before use.
Prije primjene cjepivo treba zagrijati na sobnu temperaturu, a potom dobro protresti.
Following the administration of a double dose of vaccine no side effects other than those described under “adverse reactions” have been observed.
Primjenom duple doze cjepiva, nisu primijećene nuspojave osim onih opisanih pod „Nuspojave“.
No data are available on the use of the vaccine in breeding boars.
Nema dostupnih podataka primjene cjepiva kod rasplodnih nerasta.
IM Shake well before use.
Prije primjene dobro promućkati.
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.
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.
Opalescent white, with brown resuspendable sediment.
Opalescentno bijela, sa smeđim talogom koji se lako ponovno suspendira.
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).
Pakiranje: kartonska kutija s 1 ili 10 PET bočica od 20, 50, 100, 200 ili 500 ml (10, 25, 50, 100 ili 250 doza).
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
6.6 Posebne mjere opreza pri odlaganju neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala koji proizlaze iz takvih korištenja takvih proizvoda
Zero days.
Karencija: 0 dana.
MARKETING AUTHORISATION NUMBER(S) EU/2/08/091/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/091/001- 010
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.
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.