natgillin/translations-raw huggingface dataset:
Coarse spray administration for chickens and turkeys or in drinking water use for chickens.
Primjena putem raspršivanja za piliće i pure ili vodom za piće za piliće.
Cardboard box of ten vials of 2,500, 5,000, 10,000 or 20,000 doses.
Kartonska kutija s deset bočica od 2500, 5000, 10000 ili 20000 doza.
Cardboard box of one vial of 2,500, 5,000, 10,000 or 20,000 doses.
Kartonska kutija s jednom bočicom od 2500, 5000, 10000 ili 20000 doza.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nikakve nuspojave nisu primijećene nakon primjene deseterostruke preporučene doze vakcine.
Coarse spray administration for chickens / turkeys or in drinking water use for chickens.
Primjena raspršivanjem za piliće/pure ili putem vode za piće, za piliće.
Spray vaccination or in drinking water use.
Vakcinacija raspršivanjem ili vodom za piće.
Lyophilisate for suspension for spray vaccination or for use in drinking water.
Liofilizat za suspenziju za vakcinaciju raspršivanjem ili vodom za piće.
The vaccine is supplied in type I borosilicate glass vial of 10 ml or 50 ml with a bromobutyl rubber stopper sealed with aluminium crimp caps.
Vakcina je pakovana u Tip I (borosilikatne staklene bočice od 10 ml za 2500 i 5000 doza i 50 ml za 10000 i 20000 doza s brombutilnim gumenim čepom i aluminijskom kapicom.
Poulvac E. coli lyophilisate for suspension for spray vaccination or for use in drinking water
Poulvac E. coli, liofilizat za suspenziju za vakcinaciju raspršivanjem ili vodom za piće
Name and address of the manufacturer of the biological active substance Zoetis Inc.
Naziv i adresa proizvođača biološki djelatne tvari
Poulvac E. coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens
Poulvac E. coli liofilizat za suspenziju za vakcinaciju raspršivanjem za piliće i pure ili vodom za piće za piliće
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI (I) PROIZVOĐAČ(I) ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
Veterinary medicinal product subject to prescription.
Izdaje se na veterinarski recept.
Chickens and turkeys
CILJNE VRSTE ŽIVOTINJA Pilići i pure
PACKAGE LEAFLET Poulvac E. coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens
UPUTA O VMP Poulvac E. coli, liofilizat za suspenziju za vakcinaciju raspršivanjem za piliće i pure ili vodom za piće za piliće
Zoetis Belgium SA Rue Laid Burniat 1
Zoetis Belgium SA
5.2 x 106 - 9.1 x 108 CFU* * Colony forming units when grown on tryptic soy agar plates.
tip O78, soj EC34195 *Jedinica tvorbe kolonija (colony forming units) kada se uzgaja na tripton soja agar podlogama
USA
BELGIJA
Spray vaccination or for use in drinking water.
Vakcinacija raspršivanjem ili primjena putem vode za piće.
Spray application:
Primjena raspršivanjem:
BATCH NUMBER
Zoetis Inc.
EU/1/16/1104/001
EU/1/16/1104/001 Palonosetron Accord mikrogram a
(Invented) name Strength Pharmaceutical form
(Zaštićeno) ime Doza Farmaceutski oblik
Intravenous use vial (glass) 5 ml
Za primjenu u venu bočica (staklo) 5 ml
EU/1/19/1367/001 Zynteglo cells/mL
EU/1/19/1367/001 Zynteglo stanica/ml disperzija za infuziju
1 bag (or more)
1 vrećica (ili više)
Intravenous use bag (FEP)
Vrećica (FEP)
One capsule daily.
Jedna kapsula dnevno.
The following indication should be deleted:
Sljedeću je indikaciju potrebno izbrisati:
The usual dose is one capsule a day.
Uobičajena doza je jedna kapsula dnevno.
Section 4.1: Therapeutic indications
Dio 4.1: Terapijske indikacije
Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, anti-platelet medicinal products, beta-blockers, ACE inhibitors).
Adjuvantno liječenje u sekundarnoj prevenciji nakon infarkta miokarda, uz drugu standardnu terapiju (npr. statine, antitrombocitne lijekove, beta-blokatore, ACE inhibitore).
Section 5.1 Pharmacodynamic properties
Dio 5.1. Farmakodinamička svojstva
B. Package Leaflet: Information for the patient
Uputa o lijeku: Informacije za bolesnika
Section 3
Dio 3.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Nadležna tijela države članice mogu, prema potrebi, naknadno ažurirati informacije o lijeku u suradnji s referentnom državom članicom, u skladu s postupcima utvrđenima u poglavlju 4. glave III.
Section 1
Dio 1.
The heading and information on dose after a heart attack should be deleted: Dose after a heart attack
Potrebno je izbrisati naslov i informacije o doziranju nakon srčanog udara: Doza nakon srčanog udara
Existing relevant information on use after a heart attack should be deleted.
Potrebno je izbrisati postojeće relevantne informacije o primjeni nakon srčanog udara.
Existing relevant text in section 5.1 of the SmPC in relation to “secondary prevention after myocardial infarction” indication should be deleted.
Potrebno je izbrisati postojeći relevantni tekst u dijelu 5.1. sažetka opisa svojstava lijeka koji se odnosi na indikaciju „sekundarna prevencija nakon infarkta miokarda”.
Annex III Amendments to relevant sections of the Product Information
Izmjene odgovarajućih dijelova Informacija o lijeku
For omega-3 containing medicinal products, the existing product information shall be amended (deletion of the text as appropriate) as provided below:
Postojeće informacije o lijeku za lijekove koji sadrže omega-3 kiseline će biti izmijenjene (brisanje teksta, kako je prikladno) sukladno navedenom u nastavku:
For omega-3 containing medicinal products, the existing package leaflet shall be amended (deletion of the text as appropriate) as provided below:
Postojeće upute o lijeku za lijekove koji sadrže omega-3 kiseline bit će izmijenjene (brisanje teksta, kako je prikladno) sukladno navedenom u nastavku:
Section 4.2: Posology and method of administration Information related to “secondary prevention after myocardial infarction” indication should be deleted: Post Myocardial Infarction
Potrebno je izbrisati informacije koje se odnose na indikaciju „sekundarna prevencija nakon infarkta miokarda”:
The absolute bioavailability was 74%.
Apsolutna bioraspoloživost bila je 74 %.
Wash hands after handling the product.
Operite ruke nakon rukovanja s proizvodom.
None known.
Nije poznato.
Date of first authorisation: 20/05/2019
Datum prvog odobrenja: 20/05/2019
These measures should help to protect the environment.
Te mjere bi trebale pomoći u zaštiti okoliša.
The tablets should not be divided.
Tablete ne treba dijeliti.
Macrogol 4000
Makrogol 4000
No evidence of enterohepatic recycling has been observed.
Nema dokaza enterohepatičkog recikliranja.
ATC vet code: QP53BE01.
ATCvet broj: QP53BE01.
For the full list of excipients, see section 6.1.
Za potpuni popis pomoćnih tvari, vidjeti dio 6.1.
Bodyweight of dog (kg)
Tjelesna težina psa (kg)
Return the blister with the remaining chewable tablets into the carton.
Vratite blister s preostalim tabletama u kutiju.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Budući da je demodikoza multifaktoralna bolest, u slučajevima gdje je potrebno, preporučljivo je također liječiti bilo koju osnovnu bolest na odgovarajući način.
One treatment kills ticks for up to one month.
Jedan tretman ubija krpelje do mjesec dana.
Use only according to the benefit-risk assessment by the responsible veterinarian.
Koristite samo prema procjeni koristi i rizika od strane odgovornog veterinara.
This results in uncontrolled activity of the central nervous system and death of insects or acarines.
To rezultira nekontroliranim djelovanjem središnjeg živčanog sustava i smrti insekata ili akarida.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Pitajte veterinara kako odlagati lijekove koji više nisu potrebni.
The expiry date refers to the last day of that month.
Rok valjanosti se odnosi na zadnji dan tekućeg mjeseca..
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Ukoliko primijetite bilo kakve nuspojave, čak i one koje nisu navedene u uputama o VMP ili mislite da proizvod ne djeluje, molimo obavijestite svog veterinara.
Afoxolaner MERIAL kills fleas within 8 hours and ticks within 48h.
Afoksolaner MERIAL ubija buhe unutar 8 sati i krpelje unutar 48h.
Treatment schedule:
Raspored tretmana:
The veterinary medicinal product is individually packaged in thermoformed laminated PVC blisters with paper-backed aluminium (Aclar/PVC/Alu).
Veterinarsko-medicinski proizvod je pojedinačno pakiran u termoformirane lamelirane PVC blistere s papirnato-aluminijskom podlogom (Aclear/PVC/Alu).
The product kills fleas before egg production and therefore prevents household contamination.
Proizvod ubija buhe prije proizvodnje jaja i time sprečava kontaminaciju kućanstva.
If the dog does not accept the tablets directly they may be administered with food.
Ako pas ne prihvati tabletu izravno, mogu se primjenjivati s hranom.
The product should be administered at a dose of 2.7-7 mg/kg bodyweight in accordance with the following table:
Proizvod treba davati u dozi od 2,7 - 7 mg/kg tjelesne težine u skladu sa sljedećom tablicom:
Strength and number of chewable tablets to be administered
Jačina i broj tableta za žvakanje koje treba primijeniti
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji poslije EXP.
Special warnings for each target species:
Posebna upozorenja za svaku ciljnu vrstu:
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 potječe od veterinarsko medicinskog proizvoda treba zbrinuti u skladu s lokalnim zahtjevima.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE B. UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
The terminal plasma half-life is approximately 2 weeks in most dogs; however, half-life of afoxolaner can differ between dogs (e.g. in one study, t½ in Collies at 25 mg/kg bodyweight was up to 47.7 days) with no effect on safety.
Terminalno vrijeme poluraspada u plazmi je otprilike 2 tjedna kod većine pasa, međutim poluživot afoksanera može biti različit kod pasa (npr. u jednom istraživanju poluživot u colija za dozu 25 mg/kg tjelesne težine bio je do 47,7 dana) bez utjecaja na neškodljivost.
Specific pharmacovigilance requirements:
Posebni zahtjevi za farmakovigilanciju:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding dogs.
Neškodljivost veterinarsko-medicinskog proizvoda nije ispitana tijekom graviditeta i laktacije ili u rasplodnih pasa.
This veterinary medicinal product does not require any special storage conditions.
Ovaj veterinarsko medicinski proizvod ne zahtijeva posebne uvjete čuvanja.
Each chewable tablet contains: Afoxolaner MERIAL
Svaka tableta za žvakanje sadrži: Afoksolaner MERIAL
In-vitro experiments demonstrated that P-glycoprotein efflux does not occur, confirming that afoxolaner is not a substrate for the P-glycoprotein transporters.
In-vitro eksperimenti pokazali su da se efluks vezan uz P-glikoprotein ne događa, čime je potvrđeno da afoksolaner nije supstrat za P-glikoproteinske transportere.
The periodic safety update report (PSUR) submissions shall be synchronised and submitted at the same frequency as for the reference product.
Periodička izvješća o neškodljivosti lijeka (PSUR) moraju se uskladiti i dostaviti u istim vremenskim periodima kao i za referentni proizvod.
The mean maximum concentration (Cmax) was 1,655 ± 332 ng/ml in plasma at 2-4 hours (Tmax) after a 2.5 mg/kg afoxolaner dose.
Srednja maksimalna koncentracija (Cmax) je 1,655 ± 332 ng/ml u plazmi 2-4 sata (Tmax) nakon 2,5 mg/kg afoksolaner doze.
Soy protein fines Braised beef flavouring Povidone (E1201) Macrogol 400
Aroma pirjane govedine Povidon (E1201) Makrogol 400
Afoxolaner in the dog is metabolised to more hydrophilic compounds and then eliminated.
Afoksolaner u psa se metabolizira u više hidrofilnih spojeva, a zatim eliminira.
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
U nedostatku dostupnih podataka, liječenje štenadi mlađih od 8 tjedna i/ili pasa lakših od 2 kg tjelesne težine treba temeljiti na procjeni koristi i rizika odgovornog veterinara.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females.
Laboratorijska ispitivanja na štakorima i kunićima nisu dala dokaz teratogenog učinka ili bilo kakav nepovoljan učinak na reproduktivnu sposobnost mužjaka i ženki.
1 tablet 3 tablets 6 tablets 15 tablets
6 tableta 15 tableta
For dogs above 50 kg bodyweight, use an appropriate combination of chewable tablets of different/same strengths.
Za pse iznad 50 kg tjelesne težine, koristiti odgovarajuće kombinacije žvakaćih tableta različite/iste jačine.
Further monthly administration of the product may be required based on clinical assessment and skin scrapings.
Dodatne mjesečne primjene proizvoda moguće je preporučiti na temelju kliničkog pregleda i pretrage strugotina kože.
Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family.
Afoksolaner je insekticid i akaricid koji pripada skupini izoksazolina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija
Macrogol 15 hydroxystearate Glycerol (E422) Medium-chain triglycerides
Makrogol 15 hidroksistearat Glicerol (E422) Trigliceridi srednjeg lanca
Monthly intervals throughout the flea and/or tick seasons, based on local epidemiological situations.
Mjesečnim intervalima tijekom sezone buha i/ili krpelja, na temelju lokalnih epidemioloških situacija.
Treatment of flea infestation in dogs (Ctenocephalides felis and C. canis) for at least 5 weeks.
Liječenje infestacije buhama u pasa (Ctenocephalides felis i C. canis) do najmanje 5 tjedana.
Overdose (symptoms, emergency procedures, antidotes):
Predoziranje (simptomi, postupci u slučaju nužde, protuotrov):
Afoxolaner acts at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Afoksolaner djeluje na ligandom regulirane kloridne kanale, osobito one s neurotransmiterom gama-aminomaslačnom kiselinom (GABA), čime blokira pre i post-sinaptički prijenos kloridnih iona kroz stanične membrane.
Special precautions for use in animals:
Posebne mjere opreza za uporabu na životinjama:
Treatment of demodicosis (caused by Demodex canis).
Liječenje demodikoze (uzrokovane s Demodex canis).
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Rok trajanja kad je zapakiran za prodaju: 3 godine.
Parasites need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of parasite borne diseases cannot be excluded.
Parazit mora započeti hranjenje na domaćinu kako bi započelo djelovanje afoksolanera, stoga se rizik od prijenosa krpeljno prenosivih bolesti ne može u potpunosti isključiti.
After oral administration in dogs, afoxolaner was shown to have high systemic absorption following administration.
Nakon peroralne primjene kod pasa, afoksolaner je pokazao da ima visoku sustavnu apsorpciju nakon primjene.
Afoxolaner (mg)
Afoksolaner (mg)
The selective toxicity of afoxolaner between insect/acarines and mammals may be inferred by the differential sensitivity of the insect/acarines' GABA receptors versus mammalian receptors.
Selektivna toksičnost afoksolanera za kukce/akaride i sisavce se može zaključiti po različitoj osjetljivosti GABA receptora insekata/akarida u odnosu na receptore sisavaca.
Pharmacotherapeutic group: Ectoparasiticides for systemic use.
Farmakoterapijska skupina: ostali ektoparazitici za sustavnu primjenu.
One carton contains one blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Jedna kartonska kutija sadrži blister s 1, 3, ili 6 tableta ili 15 blistera s 1 tabletom za žvakanje.
No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of two to four weeks.
Nepovoljne reakcije nisu zabilježene kod zdravih beagle štenaca u dobi od 8 tjedana, kada se tretira s dozom pet puta većom od maksimalne doze, ponovljeno 6 puta u intervalima od 2 - 4 tjedana.
Mild gastrointestinal effects (vomiting, diarrhoea), pruritus, lethargy, anorexia, and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely.
Blage nuspojave vezane uz gastrointestinalni sustav (povraćanje, proljev), pruritus, letargija, anoreksija i neurološki simptomi (konvulzije, ataksija i mišićni tremor) prijavljivane su vrlo rijetko.
The metabolites and parent compound are eliminated from the body via urinary and biliary excretion with the majority eliminated in the bile.
Metaboliti i matični spoj se eliminiraju iz tijela putem mokraće te bilijarnim izlučivanjem, s većom eliminacijom putem žuči.
The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Može se koristiti kao dio strategije liječenja za kontrolu alergijskog dermatitisa uzrokovanog buhama (FAD).
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
OSTALI UVJETI I ZAHTJEVI ZA ODOBRENJE STAVLJANJA U PROMET
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Ne koristiti u slučajevima preosjetljivosti na djelatnu tvar ili na bilo koju od pomoćnih tvari.
Afoxolaner distributes into tissues with a volume of distribution of 2.6 ± 0.6 l/kg and a systemic clearance value of 5.0 ± 1.2 ml/hr/kg.
Afoksolaner se distribuira u tkiva s volumenom raspodjele koji iznosi 2,6 ± 0,6 l/kg te sustavnim klirensom vrijednosti 5,0 ± 1,2 ml/h/kg.
Maize starch
Kukuruzni škrob
Veterinary medicinal product subject to prescription.
Veterinarsko medicinski proizvod izdaje se na recept.
Afoxolaner MERIAL
Afoksolaner MERIAL
Afoxolaner MERIAL tablets are chewable and palatable to most dogs.
Afoksolaner MERIAL tablete za žvakanje ukusne su za većinu pasa.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
Krpelji i buhe se moraju pričvrstiti na domaćina kako bi bili izloženi djelovanju djelatne tvari.
• very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
Special precautions to be taken by the person administering the veterinary medicinal product to animals To prevent children from getting access to the veterinary medicinal product, remove only one chewable tablet at a time from the blister.
Posebne mjere koje treba poduzeti osoba koja propisuje veterinarsko-medicinski proizvod Kako bi djeci spriječili pristup veterinarsko-medicinskom proizvodu, izvadite samo jednu tabletu za žvakanje u isto vrijeme iz blistera.
Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Nositelj odobrenja za stavljanje u promet Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
Liječenje invazije krpelja u pasa (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
Afoxolaner MERIAL is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, and Haemaphysalis longicornis.
Afoksolaner MERIAL djeluje protiv odraslih buha kao i na nekoliko vrsta krpelja poput Dermacentor reticulatus, D. variabilis, Ixodes ricinus i I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum i Haemaphysalis longicornis.
Severe cases may require prolonged monthly treatments.
U težim slučajevima liječenje produljiti u mjesečnim intervalima.
The tablets are chewable and palatable to most dogs.
Način primjene: Tablete za žvakanje ukusne su za većinu pasa.
• very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu (e))
Chewable tablets
Tablete za žvakanje
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Liječenje Sarcoptes-šuge (uzrokovane s Sarcoptes scabiei var.canis).
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis):
Liječenje Sarcoptes-šuge (uzrokovane sa Sarcoptes scabiei var.canis).
For oral use
Za peroralnu primjenu
Dogs 2-4 kg Dogs >4-10 kg Dogs >10-25 kg Dogs >25-50 kg
Psi od 2-4 kg Psi >4-10 kg Psi >10-25 kg Psi >25-50 kg
Monthly administration of the product until two negative skin scrapings are obtained one month apart.
Liječenje demodikoze (uzrokovane s Demodex canis) Mjesečna primjena proizvoda sve do pojave dva negativna nalaza dobivena pretragom strugotina kože uzetih u razmaku od mjesec dana.
Most reported adverse reactions were self-limiting and of short duration.
Većina nuspojava kratko traje i općenito prolaze same od sebe.
• rare (more than 1 but less than 10 animals in 10,000 animals treated)
- rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja)
Afoxolaner MERIAL 136 mg
Afoksolaner MERIAL 136 mg
Treatment of flea and tick infestations:
Liječenje infestacije buhama i krpeljima
Afoxolaner MERIAL 68 mg
Afoksolaner MERIAL 68 mg
Mottled red to reddish brown, circular shaped (tablets for dogs 2-4 kg) or rectangular shaped (tablets for dogs >4-10 kg, tablets for dogs >10-25 kg and tablets for dogs >25-50 kg).
Prošarane crvene do smeđe crvenkaste, kružnog (tablete za pse 2-4 kg) ili pravokutnog oblika (tablete za pse >4-10 kg, tablete za pse >10-25 kg i tablete za pse >25-50 kg).
Afoxolaner MERIAL 28 mg
Afoksolaner MERIAL 28 mg
Afoxolaner MERIAL 11 mg
Afoksolaner MERIAL 11 mg
chewable tablets for dogs 2-4 kg chewable tablets for dogs >4-10 kg chewable tablets for dogs >10-25 kg chewable tablets for dogs >25-50 kg
tablete za žvakanje za pse 2-4 kg tablete za žvakanje za pse >4-10 kg tablete za žvakanje za pse >10-25 kg tablete za žvakanje za pse >25-50 kg
common (more than 1 but less than 10 animals in 100 animals treated) uncommon (more than 1 but less than 10 animals in 1,000 animals treated) rare (more than 1 but less than 10 animals in 10,000 animals treated) very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- česte ( više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje 10 životinja na 1.000 tretiranih životinja)
Afoxolaner is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum and Haemaphysalis longicornis.
D. variabilis, Ixodes ricinus I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, Haemaphysalis longicornis.
Name and address of the manufacturer responsible for batch release
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE Naziv i adresa proizvođača odgovornog za puštanje serije u promet
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava je određena sljedećim pravilima: