natgillin/translations-raw huggingface dataset:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 50 MG FILM-COATED TABLETS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA FILMOM OBLOŽENE TABLETE OD 50 MG
Verzenios 150 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172)
Verzenios 150 mg filmom obložene tablete poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol (E1521) talk (E553b) željezov oksid, žuti (E172)
Verzenios 100 mg film-coated tablets Each film-coated tablet contains 100 mg abemaciclib.
Verzenios 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg abemacikliba.
0.246, 0.698); in patients who were progesterone receptor negative, the HR was 0.509 (95% CI: 0.325,
Omjer hazarda u bolesnica u predmenopauzi/perimenopauzi iznosio je 0,415 (95% CI: 0,246; 0,698), dok je u bolesnica negativnih na progesteronske receptore HR iznosio 0,509 (95% CI: 0,325; 0,797).
Alanine aminotransferase increased Aspartate aminotransferase increased a
Tablica 4. Preporuke za zbrinjavanje povišenih vrijednosti aminotransferaza Potrebno je kontrolirati vrijednosti alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST)
Grade 2
2. stupanj
Verzenios 100 mg
16. PODACI NA BRAILLEOVOM PISMU Verzenios 100 mg
Verzenios 50 mg film-coated tablets
Verzenios 50 mg filmom obložene tablete
In patients who were pre/perimenopausal, the hazard ratio was 0.415 (95% CI:
Hazard Ratio, HR]: 0,540 [95% CI:
Verzenios 50 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172) iron oxide red (E172)
Verzenios 50 mg filmom obložene tablete poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol (E1521) talk (E553b) željezov oksid, žuti (E172)
• Dizziness
• svrbež
Grade 1
1. stupanj
EU/1/18/1307/007 (14 film-coated tablets) EU/1/18/1307/008 (168 film-coated tablets) EU/1/18/1307/009 (28 x 1 film-coated tablets) EU/1/18/1307/014 (28 film-coated tablets) EU/1/18/1307/015 (56 film-coated tablets) EU/1/18/1307/020 (42 film-coated tablets) EU/1/18/1307/021 (70 film-coated tablets)
EU/1/18/1307/007 (14 filmom obloženih tableta) EU/1/18/1307/008 (168 filmom obloženih tableta) EU/1/18/1307/009 (28 x 1 filmom obložena tableta) EU/1/18/1307/014 (28 filmom obloženih tableta) EU/1/18/1307/015 (56 filmom obloženih tableta) EU/1/18/1307/020 (42 filmom obložene tablete) EU/1/18/1307/021 (70 filmom obloženih tableta)
Verzenios 150 mg
TABLETE OD 150 MG
EU/1/18/1307/001 (14 film-coated tablets) EU/1/18/1307/002 (168 film-coated tablets) EU/1/18/1307/003 (28 x 1 film-coated tablets) EU/1/18/1307/010 (28 film-coated tablets) EU/1/18/1307/011 (56 film-coated tablets) EU/1/18/1307/016 (42 film-coated tablets) EU/1/18/1307/017 (70 film-coated tablets)
EU/1/18/1307/001 (14 filmom obloženih tableta) EU/1/18/1307/002 (168 filmom obloženih tableta) EU/1/18/1307/003 (28 x 1 filmom obložena tableta) EU/1/18/1307/010 (28 filmom obloženih tableta) EU/1/18/1307/011 (56 filmom obloženih tableta) EU/1/18/1307/016 (42 filmom obložene tablete) EU/1/18/1307/017 (70 filmom obloženih tableta)
EU/1/18/1307/004 (14 film-coated tablets) EU/1/18/1307/005 (168 film-coated tablets) EU/1/18/1307/006 (28 x 1 film-coated tablets) EU/1/18/1307/012 (28 film-coated tablets) EU/1/18/1307/013 (56 film-coated tablets) EU/1/18/1307/018 (42 film-coated tablets) EU/1/18/1307/019 (70 film-coated tablets)
EU/1/18/1307/004 (14 filmom obloženih tableta) EU/1/18/1307/005 (168 filmom obloženih tableta) EU/1/18/1307/006 (28 x 1 filmom obložena tableta) EU/1/18/1307/012 (28 filmom obloženih tableta) EU/1/18/1307/013 (56 filmom obloženih tableta) EU/1/18/1307/018 (42 filmom obložene tablete) EU/1/18/1307/019 (70 filmom obloženih tableta)
Neutropenia
Doziranje
Verzenios 50 mg film-coated tablets abemaciclib
Verzenios 50 mg filmom obložene tablete abemaciklib
Verzenios 100 mg film-coated tablets
Verzenios 100 mg filmom obložene tablete
Warnings and precautions
Preporuke za zbrinjavanje
Verzenios 50 mg tablets abemaciclib
NAZIV LIJEKA Verzenios 50 mg tablete abemaciklib
Verzenios 150 mg tablets abemaciclib
NAZIV LIJEKA Verzenios 150 mg tablete abemaciklib
Verzenios 150 mg film-coated tablets abemaciclib
Verzenios 150 mg filmom obložene tablete abemaciklib
The primary endpoint was investigator-assessed progression-free survival (PFS) evaluated according to RECIST 1.1; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Primarna mjera ishoda bilo je preživljenje bez progresije bolesti (engl. progression-free survival, PFS) prema ocjeni ispitivača na temelju verzije 1.1 Kriterija za ocjenu odgovora kod solidnih tumora (engl.
Verzenios 100 mg film-coated tablets abemaciclib
Verzenios 100 mg filmom obložene tablete abemaciklib
Verzenios 150 mg abemaciclib
NAZIV LIJEKA Verzenios 150 mg abemaciklib
Verzenios 100 mg tablets abemaciclib
NAZIV LIJEKA Verzenios 100 mg tablete abemaciklib
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER CARD FOR 150 MG FILM-COATED TABLETS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KALENDARSKA BLISTER KARTICA ZA FILMOM OBLOŽENE TABLETE OD 150 MG
Eli Lilly Italia S.p.A. Tel: + 39- 055 42571
Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER CARD FOR 50 MG FILM-COATED TABLETS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KALENDARSKA BLISTER KARTICA ZA FILMOM OBLOŽENE TABLETE OD 50 MG
Verzenios 50 mg
16. PODACI NA BRAILLEOVOM PISMU Verzenios 50 mg
Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER CARD FOR 100 MG FILM-COATED TABLETS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KALENDARSKA BLISTER KARTICA ZA FILMOM OBLOŽENE TABLETE OD 100 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 150 MG FILMCOATED TABLETS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ULOŽEN U KALENDARSKU BLISTER KARTICU ZA FILMOM OBLOŽENE TABLETE OD 150 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 50 MG FILMCOATED TABLETS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ULOŽEN U KALENDARSKU BLISTER KARTICU ZA FILMOM OBLOŽENE TABLETE OD 50 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 100 MG FILMCOATED TABLETS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ULOŽEN U KALENDARSKU BLISTER KARTICU ZA FILMOM OBLOŽENE TABLETE OD 100 MG
Progression-free survival (PFS) was significantly prolonged in the Verzenios plus aromatase inhibitor (AI) arm, (Hazard Ratio [HR] of 0.540 [95% CI, 0.418 to 0.698]); median PFS was 28.18 months in the Verzenios plus AI arm and was 14.76 months in the placebo plus AI arm.
0,418 - 0,698]); medijan PFS-a iznosio je 28,18 mjeseci u skupini koja je primala Verzenios plus inhibitor aromataze te 14,76 mjeseci u skupini koja je primala placebo plus inhibitor aromataze.
Verzenios 100 mg abemaciclib
NAZIV LIJEKA Verzenios 100 mg abemaciklib
Very common
I DOHVATA
Verzenios 50 mg film-coated tablets Each film-coated tablet contains 50 mg abemaciclib.
KVALITATIVNI I KVANTITATIVNI SASTAV Verzenios 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg abemacikliba.
Please refer to the Summary of Product Characteristics of the endocrine therapy combination partner for the recommended posology.
Za preporučeno doziranje endokrine terapije koja se primjenjuje u kombinaciji s abemaciklibom vidjeti sažetak opisa svojstava lijeka za tu endokrinu terapiju.
- The active substance is abemaciclib.
Što Verzenios sadrži - Djelatna tvar je abemaciklib.
Verzenios 50 mg abemaciclib
NAZIV LIJEKA Verzenios 50 mg abemaciklib
Management recommendations for diarrhoea
Preporuke za zbrinjavanje proljeva
• Dry mouth
• suha usta
Package leaflet: Information for the patient Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets abemaciclib This medicine is subject to additional monitoring.
Verzenios 50 mg filmom obložene tablete Verzenios 100 mg filmom obložene tablete Verzenios 150 mg filmom obložene tablete abemaciklib
Overall survival was not mature at the final PFS analysis (133 events observed across the two arms).
(133 događaja opažena u obje skupine).
Protect from light.
Zaštititi od svjetla.
In case of such reactions, appropriate treatment is recommended.
U slučaju takvih reakcija preporuča se prikladna terapija.
Lot: {number}
Lot: {broj}
CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA
ATC Vet Code: QI09AA07
ATCvet kôd: QI09AA07
1348 Louvain-la-Neuve BELGIUM
1348 Louvain-la-Neuve BELGIJA
10 doses (20 ml)
10 doza (20 ml)
Sulfolipo-cyclodextrin (SLCD)
Sulfolipo-ciklodekstrin (SLCD)
Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days.
Lokalna reakcija tkiva u obliku otekline na mjestu aplikacije je vrlo česta i može trajati do 26 dana.
Interactions with other medicinal products and other forms of interaction:
Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:
Overdose (symptoms, emergency procedures, antidotes):
Predoziranje (simptomi, hitni postupci, antidoti):
a) The administration of the veterinary medicinal 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.
a) će primjena veterinarsko-medicinskog proizvoda na životinjama interferirati s provedbom nacionalnih programa za otkrivanje, kontrolu i iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
Avoid stress in the animals before and after the time of vaccination.
Treba izbjegavati stres u životinja prije i nakon vakcinacije.
Vaccination schedule:
Program vakcinacije:
Hepes acid
Hepes kiselina
SPECIAL WARNING(S), IF NECESSARY
POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO
Pigs (piglets)
Svinje (prasad)
50 doses 125 doses
125 doza
Zero days.
Nula dana.
Pigs (piglets) from 3 weeks of age.
Svinje (prasad) starije od 3 tjedna života.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Nema dostupnih podataka o neškodljivosti i učinkovitosti ovog cjepiva kada se koristi zajedno sa bilo kojim drugim veterinarsko-medicinskim proizvodom.
Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Svaka osoba koja namjerava proizvoditi, uvoziti, posjedovati, prodavati, opskrbljivati i koristiti ovaj veterinarsko-medicinski proizvod mora prethodno konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju, jer te aktivnosti mogu biti zabranjene u državi članici, u cijelosti ili samo na djelu njezinog teritorija, u skladu s nacionalnim zakonodavstvom.
EU/2/09/099/001-006
ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/099/001-006
Store and transport refrigerated (2 °C - 8 °C).
Čuvati i prevoziti na hladnom (2 ⁰C - 8 ⁰C).
Shelf life after first opening the immediate packaging: use immediately.
Rok valjanosti nakon prvog otvaranja unutarnjeg pakiranja: iskoristiti odmah.
Zoetis Manufacturing & Research Spain, S.L.
Zoetis Manufacturing & Research Spain, S.L. Ctra.
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:
Sukladno članku 71. Direktive 2001/82/EK 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 ili na dijelu svog teritorija ako je utvrđeno da:
The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur.
Površina reakcije je uglavnom do 5 cm u promjeru iako u nekim slučajevima može biti i veća.
Vaccinate only healthy animals.
Cijepiti samo zdrave životinje.
Use vaccination devices according to the manufacturer's instructions.
Koristite automatske aplikatore u skladu s uputama proizvođača.
Date of first authorisation: 24/07/2009 Date of last renewal: 06/06/2014
Datum zadnje obnove: 06/06/2014
EXP {month/year} Once broached use immediately.
ROK VALJANOSTI EXP {mjesec/godina} Jednom otvorenu bočicu odmah upotrijebiti.
These clinical signs normally resolve without treatment.
Navedeni klinički znaci najčešće prolaze bez dodatne terapije.
Minimum Essential Medium without phenol red Sodium bicarbonate
Minimalni esencijalni medij bez fenol crvene
The excipients 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 adjuvanse), navedene u dijelu 6.1 SPC su ili dozvoljene 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 (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko-medicinskim proizvodima.
0.1 mg * Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
*Jedinica relativne potencije određena ELISA određivanjem količine antigena (in vitro test potencije)
Do not mix with any other veterinary medicinal product.
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom.
Special warnings for each target species:
Posebna upozorenja za svaku od ciljnih vrsta životinja:
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, koje su namijenjene za stvaranje aktivne imunosti i na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Odluku o primjeni ovog cjepiva prije ili poslije bilo kojeg drugog veterinarsko-medicinskog proizvoda treba pojedinačno donijeti ovisno od slučaja do slučaja.
The benefit of the vaccination of pigs with very high levels of maternally-derived antibodies, e.g. due to vaccination of their mothers, has not been demonstrated.
Korist vakcinacije prasadi koja ima visoku koncentraciju maternalnih antitijela zbog npr. vakcinacije krmača, nije dokazana.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle.
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici poslije EXP.
Duration of immunity: 19 weeks post-vaccination.
Trajanje imunosti: 19 tjedana nakon vakcinacije.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobivenih primjenom tih veterinarsko-medicinskih proizvoda mora se odlagati u skladu s lokalnim propisima.
Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Proizvođač odgovoran za puštanje serije u promet: Zoetis Manufacturing & Research Spain, S.L. Ctra.
Severe anaphylactic reactions are uncommon but may be lethal.
Teške anafilaktičke reakcije su manje česte, ali mogu biti smrtonosne.
Immediate mild hypersensitivity-like reactions may occur commonly after vaccination, resulting in transient clinical signs such as vomiting.
Trenutna blaga reakcija slična reakciji preosjetljivosti često se može javiti nakon cijepljenja, rezultira prolaznim kliničkim znacima kao što je povraćanje.
Shelf life of the veterinary medicinal product as package for sale: 2 years.
6.3 Rok valjanosti Rok valjanosti veterinarsko-medicinskog proizvoda kada je zapakiran za prodaju: 2 godine .
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
13. RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA ” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, AKO JE PRIMJENJIVO
The use of a multi-dosing syringe is recommended.
Upotreba više doznih injektora je preporučena.
Suspension for injection
Suspenzija za injekciju
Withdrawal period(s): Zero days.
Karencija(e): Nula dana.
In clinical studies, a post-mortem examination of the injection site, performed 8 weeks after the administration of a single dose of the vaccine, revealed a mild to moderate granulomatous inflammation of the muscular fibres at the injection site.
Prilikom kliničke studije, patoanatomski nalaz mjesta aplikacije izvršene osam tjedana nakon aplikacije jedne doze vakcine pokazao je blagu do umjerenu granulomatoznu upalu mišićnog tkiva.
Suvaxyn PCV suspension for injection for pigs
Suvaxyn PCV suspenzija za injekciju za svinje
Medicines should not be disposed of via wastewater or household waste.
Veterinarsko-medicinski proizvodi se ne smiju odlagati u otvorene vode ili kućni otpad.
Do not use in breeding boars.
Ne davati rasplodnim nerastovima.
One dose of 2 ml contains:
Jedna doza od 2 ml sadržava:
QUANTITY OF THE ACTIVE SUBSTANCES
KOLIČINA DJELATNE(IH) TVARI
A transient increase in body temperature (up to 1.7 °C) is very common during the first 24 hours after vaccination.
Vrlo čest je prolazni porast tjelesne temperature (do 1,7 ⁰C) u prvih 24 sata nakon vakcinacije, koji se spontano povlači unutar 48 sati bez liječenja.
Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 21 days of age.
Jedna intramuskularna injekcija u vrat svinje, iza uha u dozi od 2 ml prasadi starijoj od 21 dan.
Onset of immunity: from 3 weeks post-vaccination.
Početak imunosti: 3 tjedna nakon vakcinacije.
Single intramuscular injection of one dose (2 ml).
Jedna intramuskularna injekcija u dozi od 2 ml.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET
Major incompatibilities: Do not mix with any other veterinary medicinal product.
Inkompatibilnosti:Ovaj proizvod se ne smije miješati s drugim veterinarsko-medicinskim proizvodima.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
U slučaju da se nehotice samoinjiciranja, odmah potražite pomoć liječnika i pokažite mu uputu o VMP
It is intended to stimulate active immunity against PCV2 in piglets.
Namijenjen za stimulaciju aktivne imunosti protiv PCV2 kod prasadi.
Pharmacotherapeutic group: Immunologicals for suidae, inactivated viral vaccine.
Farmakoterapijska skupina: Imunološki proizvodi za svinje (Suidae), inaktivirano virusno cjepivo
Due to new field strains (PCV genotype), lack of expected efficacy (LEE) events should be submitted electronically on a yearly basis.
Zbog novih terenskih sojeva (PCV genotip), nedostatak očekivane učinkovitosti (eng.
Cardboard box containing polyethylene bottles with a chlorobutyl elastomer closure and sealed with an aluminium cap.
6.5 Osobine i sastav unutarnjeg pakovanja Kartonska kutija sadrži polietilensku bočicu sa klorbutilnim elastomernim čepom i aluminijskom kapicom.
b) The disease to which the product is intended to confer immunity is largely absent from the territory in question.
b) je bolest za koju je odnosni veterinarsko-medicinski proizvod namijenjen da pruži imunost, odsutna s tog područja.
A milky white to pink opaque liquid, free from visible particles
Mliječno bijela do ružičasta neprozirna tekućina, bez vidljivih čestica
Pregnancy and lactation: Do not use during pregnancy and lactation.
Ne primjenjivati tijekom graviditeta i laktacije.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
PACKAGE LEAFLET: Suvaxyn PCV suspension for injection for pigs
UPUTA O VMP: Suvaxyn PCV suspenzija za injekciju za svinje
Name and address of the manufacturer of the biological active substance(s)
Naziv i adresa proizvođača biološki djelatne tvari
Shake well before administration and intermittently during the process of vaccination.
Dobro protresti prije uporabe te povremeno i za vrijeme vakcinacije.
Cardboard box of 10 bottles of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Kartonska kutija s deset bočica od 10 doza (20 ml), 50 doza (100 ml) ili 125 doza (250 ml).
Administer one dose of 2 ml to piglets in the neck behind the ear.
Vakcina se daje u dozi od 2 ml u vrat, iza uha prasadi.
Intramuscular use
Intramuskularna primjena
Cardboard box of 1 bottle of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Kartonska kutija s jednom bočicom od 10 doza (20 ml), 50 doza (100 ml) ili 125 doza (250 ml).
Veterinary medicinal product subject to prescription.
Veterinarsko-medicinski proizvod se izdaje na veterinarski recept.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle label 50 and 125 doses
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Staklena bočica/etiketa 50 i 125 doza
The vaccine is to be administered aseptically.
Treba provesti aseptičke mjere prilikom vakcinacije.
Store and transport refrigerated.
11. POSEBNI UVJETI ČUVANJA Čuvati i prevoziti na hladnom.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
Adjuvants:
Adjuvansi:
CLINICAL PARTICULARS 4.1 Target species
4.1 Ciljne vrste životinja
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products, if appropriate
6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
Exceptionally, a large proportion of animals may react in some specific herds after vaccination.
U izuzetnim slučajevima, velika većina jedinki u specifičnim stadima može reagirati.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Boxes of 10 bottles of 10, 50 or 125 doses Boxes of 1 bottle of 10, 50 or 125 doses
PODACI NA KOJI SE MORAJU NALAZITI VANJSKOM PAKOVANJU Kartonska kutija s jednom bočicom od 10, 50 ili 125 doza Kartonska kutija s deset bočica od 10, 50 ili 125 doza
Name and address of the manufacturer responsible for batch release
Naziv i adresa proizvođača odgovornog za puštanje serije u promet
Box of 10 bottles of 10 doses Box of 10 bottles of 50 doses Box of 10 bottles of 125 doses
Kartonska kutija s deset bočica od 10 doza Kartonska kutija s deset bočica od 50 doza Kartonska kutija s deset bočica od 125 doza
The vaccine strain is an inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein.
Vakcinalni soj je inaktivirani rekombinirani cirkovirus svinja tip 1 s izraženim proteinom ORF2 cirkovirusa svinja tip 2.
Box of 1 bottle of 10 doses Box of 1 bottle of 50 doses Box of 1 bottle of 125 doses
Kartonska kutija s jednom bočicom od 10 doza Kartonska kutija s jednom bočicom od 50 doza Kartonska kutija sa jednom bočicom od 125 doza
Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein 1.6 ≤ RP ≤ 5.3
Inaktivirani rekombinirani cirkovirus svinja tip 1 s izraženim proteinom ORF2 1,6 ≤ RP ≤ 5,3 cirkovirusa svinja tip 2