FrancophonIA/ELRC3.0 huggingface dataset:
English: You can also report side effects directly via the national reporting system listed in Appendix V.. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: Ovaleap 450 IU/0.75 mL solution for injection
Croatian: Ovaleap 450 IU/0,75 ml otopina za injekciju
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 300 IU/0.5 mL solution for injection Ovaleap 450 IU/0.75 mL solution for injection Ovaleap 900 IU/1.5 mL solution for injection
Croatian: Ovaleap 300 IU/0,5 ml otopina za injekciju Ovaleap 450 IU/0,75 ml otopina za injekciju Ovaleap 900 IU/1,5 ml otopina za injekciju
English: Ovaleap 300 IU/0.5 mL: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution.
Croatian: Ovaleap 300 IU/0,5 ml: jedan uložak sadrži 300 IU (što odgovara 22 mikrograma) folitropina alfa u 0,5 ml otopine.
English: 1 cartridge with 1.5 mL solution and 20 injection needles
Croatian: 1 uložak s 1,5 ml otopine i 20 igala za injekciju
English: Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 1.5 mL of solution..
Croatian: Uložak (staklo tipa I) s gumenim klipom (bromobutilna guma) i poklopcem (aluminij) s pregradom (bromobutilna guma), koji sadrži 1,5 ml otopine.
English: The patient is recommended to have coitus on the day of, and the day following, hCG administration.
Croatian: Pacijentici se preporučuje spolni odnos istog dana ili dan nakon primjene hCG.
English: The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Croatian: Pacijentici se preporučuje spolni odnos na dan primjene hCG i dan poslije.
English: Ovaleap 900 IU/1.5 mL solution for injection
Croatian: Ovaleap 900 IU/1,5 ml otopina za injekciju
English: Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 0.75 mL of solution..
Croatian: Uložak (staklo tipa I) s gumenim klipom (bromobutilna guma) i poklopcem (aluminij) s pregradom (bromobutilna guma), koji sadrži 0,75 ml otopine.
English: Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomifene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of follitropin alfa needed to elicit an adequate ovarian response.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Istovremena primjena folitropina alfa s drugim lijekovima koji se primjenjuju za stimulaciju ovulacije (npr. hCG, klomifen citrat) može pojačati odgovor folikula, dok istovremena primjena agonista ili antagonista
English: When an optimal response is obtained, a single injection of 250 micrograms recombinant human choriogonadotropin alfa (r-hCG) or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa injection.
Croatian: Kad se dobije optimalni odgovor, potrebno je primijeniti jednu injekciju od 250 mikrograma rekombinantnog humanog koriogonadotropina alfa (r-hCG) ili 5000 IU do 10 000 IU hCG 24-48 sata nakon zadnje injekcije folitropina alfa.
English: 1 cartridge with 0.5 mL solution and 10 injection needles
Croatian: 1 uložak s 0,5 ml otopine i 10 igala za injekciju
English: Benzalkonium chloride
Croatian: folitropin alfa
English: Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 0.5 mL of solution.
Croatian: Uložak (staklo tipa I) s gumenim klipom (bromobutilna guma) i poklopcem (aluminij) s pregradom (bromobutilna guma), koji sadrži 0,5 ml otopine.
English: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution for injection.
Croatian: Jedan uložak sadrži 900 IU (što odgovara 66 mikrograma) folitropina alfa u 1,5 ml otopine za injekciju.
English: The medicinal product must be discarded if it has not been used after 3 months.
Croatian: Ako se nije primijenio, lijek se mora baciti nakon 3 mjeseca.
English: This side effect is common (may affect up to 1 in 10 people).
Croatian: Ova nuspojava je česta (mogu se javiti u manje od 1 na 10 osoba).
English: 1 cartridge with 0.75 mL solution and 10 injection needles
Croatian: 1 uložak s 0,75 ml otopine i 10 igala za injekciju
English: Package leaflet: Information for the user Ovaleap 300 IU/0.5 mL solution for injection Ovaleap 450 IU/0.75 mL solution for injection Ovaleap 900 IU/1.5 mL solution for injection follitropin alfa
Croatian: Ovaleap 300 IU/0,5 ml otopina za injekciju Ovaleap 450 IU/0,75 ml otopina za injekciju Ovaleap 900 IU/1,5 ml otopina za injekciju folitropin alfa
English: A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG is administered 24-48 hours after the last follitropin alfa injection to induce final follicular maturation.
Croatian: Jedna injekcija od 250 mikrograma r-hCG ili 5000 IU do 10 000 IU hCG primjenjuje se 24-48 sati nakon zadnje injekcije folitropina alfa da bi se izazvalo konačno sazrijevanje folikula.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovaleap 450 IU/0.75 mL injection follitropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ovaleap 450 IU/0,75 ml injekcija folitropin alfa s.c.
English: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution for injection.
Croatian: Jedan uložak sadrži 450 IU (što odgovara 33 mikrograma) folitropina alfa u 0,75 ml otopine za injekciju.
English: When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa and lutropin alfa injections.
Croatian: Kad se dobije optimalni odgovor, potrebno je primijeniti jednu injekciju od 250 mikrograma r-hCG ili 5000 IU do najviše 10 000 IU hCG 24-48 sati nakon zadnje injekcije folitropina alfa i lutropina alfa.
English: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution for injection.
Croatian: Jedan uložak sadrži 300 IU (što odgovara 22 mikrograma) folitropina alfa u 0,5 ml otopine za injekciju.
English: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution.
Croatian: Jedan uložak sadrži 900 IU (što odgovara 66 mikrograma) folitropina alfa u 1,5 ml otopine.
English: The best time to have sex is on the day of the hCG
Croatian: Najbolje vrijeme za spolni odnos je na dan injekcije hCG i dan poslije.
English: Ovaleap 300 IU/0.5 mL solution for injection
Croatian: Ovaleap 300 IU/0,5 ml otopina za injekciju
English: Sodium dihydrogen phosphate dihydrate Sodium hydroxide (2 M) (for pH adjustment) Mannitol
Croatian: 6.1 Popis pomoćnih tvari natrijev dihidrogenfosfat dihidrat natrijev hidroksid (2 M) (za podešavanje pH) manitol metionin polisorbat 20 benzilni alkohol benzalkonijev klorid voda za injekcije
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 450 IU/0.75 mL solution for injection follitropin alfa
Croatian: Ovaleap 450 IU/0,75 ml otopina za injekciju folitropin alfa
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 900 IU/1.5 mL solution for injection follitropin alfa
Croatian: Ovaleap 900 IU/1,5 ml otopina za injekciju folitropin alfa
English: • Stomach ache
Croatian: • rast dojki
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.5 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često reakcije na mjestu injiciranja (npr. bol, eritem, hematom, oticanje i/ili nadraženost na mjestu injiciranja)
English: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution.
Croatian: Jedan uložak sadrži 300 IU (što odgovara 22 mikrograma) folitropina alfa u 0,5 ml otopine.
English: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
Croatian: Jedan uložak sadrži 450 IU (što odgovara 33 mikrograma) folitropina alfa u 0,75 ml otopine.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovaleap 900 IU/1.5 mL injection follitropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ovaleap 900 IU/1,5 ml injekcija folitropin alfa s.c.
English: Thromboembolism (both in association with and separate from OHSS)
Croatian: Krvožilni poremećaji vrlo rijetko tromboembolija (povezana ili nepovezana s OHSS-om)
English: MARKETING AUTHORISATION NUMBER(S) Ovaleap 300 IU/0.5 mL solution for injection EU/1/13/871/001
Croatian: Ovaleap 300 IU/0,5 ml otopina za injekciju EU/1/13/871/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/871/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/871/002
English: Multiple pregnancy
Croatian: Višeplodna trudnoća
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovaleap 300 IU/0.5 mL injection follitropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ovaleap 300 IU/0,5 ml injekcija folitropin alfa s.c.
English: The single injection will be 250 micrograms of r-hCG or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last injections of Ovaleap and lutropin alfa.
Croatian: Jedna injekcija imat će 250 mikrograma r-hCG, ili 5000 do 10 000 IU hCG, a daje se 24 do 48 sati nakon zadnje injekcije Ovaleapa i lutropina alfa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/871/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/871/001
English: The single injection will be 250 micrograms of r-hCG or 5,000 to 10,000 IU of hCG, 24 to 48 hours after the last Ovaleap injection.
Croatian: Jedna injekcija iznosit će 250 mikrograma r-hCG ili 5000 do 10 000 IU hCG, 24 do 48 sati nakon zadnje injekcije Ovaleapa.
English: Very rare
Croatian: Urođene mane
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 300 IU/0.5 mL solution for injection follitropin alfa
Croatian: Ovaleap 300 IU/0,5 ml otopina za injekciju folitropin alfa
English: Methionine
Croatian: • mučnina
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/871/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/871/003
English: The effects of using too much Ovaleap are unknown.
Croatian: Ako primijenite više Ovaleapa nego što ste trebali Učinci primjene previše Ovaleapa nisu poznati.
English: • Feeling sick
Croatian: • bol u trbuhu
English: Mild or moderate OHSS (including associated symptomatology)
Croatian: Poremećaji reproduktivnog sustava i dojki vrlo često ciste na jajnicima često blagi ili umjereni OHSS (uključujući povezanu simptomatologiju)
English: • Breast development
Croatian: • nadutost trbuha
English: BATCH NUMBER Batch
Croatian: 13. BROJ SERIJE Lot
English: Do not use on an empty stomach.
Croatian: Ne primjenjivati na prazan želudac.
English: Halofuginone
Croatian: Halofuginon
English: The time necessary to obtain the maximum concentration Tmax is 11 hours.
Croatian: Vrijeme potrebna da se postigne najviša koncentracija je 11 sati.
English: The product should not enter watercourses as this may be dangerous for fish and other aquatic organisms.
Croatian: Proizvod ne treba odlagati u otvorene vode jer to može biti opasno za ribe i druge vodene organizme.
English: Once broached, use by …
Croatian: Jednom otvoren upotrijebiti do ...
English: Interaction with other medicinal products and other forms of interaction
Croatian: 4.8 Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija
English: If eye irritation persists, seek medical advice.
Croatian: Ako se nadraženost očiju nastavi, potražiti pomoć liječnika.
English: Rehydration may be necessary.
Croatian: Možda će biti potrebna i rehidracija životinje.
English: Αθηνών - Λαμίας EL-14452, Μεταμόρφωση Τηλ.
Croatian: EL-14452, Μεταμόρφωση
English: EXP {month/year} Once opened use within 6 months.
Croatian: EXP {mjesec/godina} Jednom otvoren upotrijebiti unutar 6 mjeseci.
English: The consecutive treatment should be administered at the same time each day.
Croatian: Primjenu VMP-a treba obavljati u isto vrijeme svakog dana.
English: VIRBAC Sp. z o.o.
Croatian: VIRBAC Sp. z o.o. ul.
English: Not for use in animals from which milk is produced for human consumption.
Croatian: Ne primjenjivati životinjama čije mlijeko se koristi za ljudsku upotrebu.
English: It is mainly active on the free stages of the parasite (sporozoïte, merozoïte).
Croatian: Uglavnom je učinkovita protiv slobodnih faza parazita (sporoziti, merozoiti).
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Croatian: Za bilo koju informaciju o ovom veterinarsko-medicinskom proizvodu molimo kontaktirajte lokalnog predstavnika nositelja odobrenja za stavljanje u promet:
English: The active substance in Kriptazen is an allowed substance as described in Table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar u Kriptazen je dozvoljena tvar kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010:
English: The maximum concentration in plasma Cmax is 4 ng/ml.
Croatian: Najviša koncentracija u plazmi je 4 ng/mL.
English: Halofuginone Halofuginone Bovine 10 μg/kg
Croatian: Halofuginon Halofuginon Goveda 10 μg/kg
English: Meat and offal: 13 days.
Croatian: Meso i jestive iznutrice: 13 dana.
English: 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.
Croatian: Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno 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.
English: Do not use in cases of diarrhoea established for more than 24 hours and in weak animals.
Croatian: Ne primjenjivati kada je proljev prisutan više od 24 sata i kod slabih životinja.
English: - Repetitive contact with the product may lead to skin allergies.
Croatian: Učestali dodir sa proizvodom može dovesti do alergija.
English: The product is mainly excreted in the urine.
Croatian: Uglavnom se izlučuje putem urina.
English: The terminal elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral administration.
Croatian: Eliminacijski poluživot je 11,7 sati nakon primjene u venu i 30,84 sati nakon primjene kroz usta.
English: Highest values have been found in the liver and the kidney.
Croatian: Najviše vrijednosti su pronađene u tkivu jetre i bubrega.
English: If product remains in the bottle, leave the pump attached until further use.
Croatian: Ako u boci ostane sadržaja ostavite pumpu na boci do ponovne uporabe.
English: United Kingdom Virbac Ltd,
Croatian: Virbac Ltd,
English: Administration should start in the first 24 to 48 hours of age.
Croatian: Primjenu treba započeti u prvih 24 - 48 sati od teljenja.
English: 10) Always replace the bottle in the box.
Croatian: 10) Uvijek zamijenite bocu u kutiji.
English: 9) Always replace the bottle in the box.
Croatian: 9) Uvijek zamijenite bocu u kutiji.
English: For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution.
Croatian: Kod anoreksične teladi proizvod treba primijeniti u pola litre otopine elektrolita.
English: Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration.
Croatian: Simptomi toksičnosti su proljev, krv u izmetu, odbijanje mlijeka prilikom hranjenja, dehidracija, apatija i klonulost.
English: Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi,
English: Tartrazine (E 102)
Croatian: Tartrazin(E 102)
English: Unchanged halofuginone is the major component in the tissues.
Croatian: Nevezani halofuginon je glavni sastojak tkiva.
English: Antiparasitic agents/ Agents acting against protozoa
Croatian: Antiparazitik sa djelovanjem protiv protozoa
English: 4 to 12 ml pump
Croatian: Pumpa od 4 - 12 mL
English: Halofuginone (as lactate salt)
Croatian: Halofuginon (kao sol laktata)
English: Use during pregnancy, lactation or lay
Croatian: 4.7 Primjena tijekom graviditeta, laktacije ili nesenja
English: The concentrations to inhibit 50% and 90% of the parasites, in an in vitro test system, are IC50 < 0.1 μg/ml and IC90 of 4.5 μg/ml, respectively.
Croatian: parazite u in vitro testovima je IC50 < 0,1 μg/ml i IC90 of 4,5 μg/ml.
English: - Wash hands after use.
Croatian: Nakon rukovanja proizvodom, oprati ruke.
English: Carton with bottle and dosing device
Croatian: Kutija s bocom i uređajem za doziranje
English: Shelf-life after first opening the immediate packaging: 6 months.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 6 mjeseci.
English: Magyarország VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21., HU-1055 Budapest Teл: +36703387177
Croatian: VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21., HU-1055 Budapest Teл: +36703387177
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija
English: In both cases, the reduction of oocysts excretion has been demonstrated.
Croatian: Smanjenje izlučivanja oocista je zabilježeno u oba slučaja.
English: The plasmatic concentrations of halofuginone after repeated oral administrations are comparable to the pharmacokinetic pattern after single oral treatment.
Croatian: Koncentracija halofuginona u plazmi nakon višestruke uzastopne primjene odgovara farmakokinetičkom obrascu nakon jednostruke primjene kroz usta.
English: 8) Continue using until the bottle is empty.
Croatian: 8) Nastavite primjenu dok ne ispraznite bocu.
English: Indications for use, specifying the target species
Croatian: 4.2 Indikacije za primjenu, navesti ciljne vrste životinja
English: Major Incompatibilities
Croatian: 6.2 Glavne inkompatibilnosti
English: Administer after colostrum feeding, or after milk or milk replacer feeding only, using an appropriate device for oral administration.
Croatian: Primijeniti nakon hranjenja kolostrumom, mlijekom ili mliječnom zamjenicom koristeći primjerenu opremu za primjenu.
English: 7) Continue using until the bottle is empty.
Croatian: 7) Nastavite primjenu dok ne ispraznite bocu.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 490 ml or 980 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Boca od 490 mL ili 980 mL
English: MARKETING AUTHORISATION NUMBERS EU/2/18/234/001-006
Croatian: EU/2/18/234/001-006
English: Target species
Croatian: CILJNE VRSTE ŽIVOTINJA
English: The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles).
Croatian: Djelatna tvar, halofuginon je sredstvo protiv protozoa, derivat iz grupe kinazolinona (nitrogeni poliheterociklidi).
English: The bioavailability of the drug in the calf following single oral administration is about 80%.
Croatian: Bioraspoloživost kod teladi prilikom samo jedne primjene kroz usta je 80%.
English: NOTE: The package leaflet on the market shall mention either the 4 ml pump or the 4 to 12 ml pump or the refill bottle without a pump as appropriate.
Croatian: Upute o VMP na tržištu, prema potrebi, moraju navesti ili pumpu od 4 ml ili pumpu od 4 do 12 ml ili nadomjesnu bocu ( Refill ) bez pumpe.
English: Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists.
Croatian: Jednom kada je VMP primijenjen, treba ga primjenjivati kod sve novorođene i nadolazeće teladi, sve dok postoji opasnost od proljeva izazvanog s C. parvum.
English: - In case of skin and eye contact wash the exposed area thoroughly with clean water.
Croatian: U slučaju dodira proizvoda sa kožom ili očima, odmah isprati većom količinom čiste vode.
English: 4 ml pump
Croatian: Pumpa od 4 mL
English: Marker residue Animal species MRLs
Croatian: Životinj ska vrsta MRL
English: Carton with bottle only Refill
Croatian: Kutija s bocom Refill
English: 4) Turn the ring, in order to select the weight of the calf to be treated.
Croatian: 4) Okrenite prsten kako bi odredili težinu životinje.
English: For oral use in calves after feeding.
Croatian: Za primjenu kroz usta, kod teladi nakon hranjenja.
English: The compound has a cryptosporidiostatic effect on Cryptosporidium parvum.
Croatian: Djelatna tvar pokazuje kriptosporidiostatski učinak prema Cryptosporidium parvum.
English: Luxembourg/Luxemburg VIRBAC BELGIUM NV Esperantolaan 4
Croatian: VIRBAC BELGIUM NV Esperantolaan 4
English: Disposal : read package leaflet.
Croatian: Odlaganje: pročitati uputu o VMP.
English: Should clinical signs of overdosing occur, the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer.
Croatian: Pojave li se znakovi toksičnosti, primjenu VMP-a treba odmah prekinuti, a životinju nastaviti hraniti sa mlijekom ili mliječnom zamjenicom bez VMP-a.
English: Package without a metering pump:
Croatian: Pakovanje bez mjerne pumpe:
English: STATEMENT OF ACTIVE SUBSTANCES Each ml contains:
Croatian: Svaki mL sadržava:
English: ATCvet code: QP51AX08.
Croatian: Farmakoterapijska grupa: Ostala protuprotozalna sredstva, halofuginon ATCvet kod: QP51AX08.
English: Administration should start within 24 hours after the onset of diarrhoea.
Croatian: Primjenu treba započeti unutar 24 sata od početka proljeva.
English: EU/2/18/234/001 (490 ml bottle) EU/2/18/234/002 (980 ml bottle) EU/2/18/234/003 (490 ml bottle + 4 ml dosing pump) EU/2/18/234/004 (980 ml bottle + 4 ml dosing pump) EU/2/18/234/005 (490 ml bottle + 4-12 ml dosing pump) EU/2/18/234/006 (980 ml bottle + 4-12 ml dosing pump)
Croatian: EU/2/18/234/001 (490 ml boca) EU/2/18/234/002 (980 ml boca) EU/2/18/234/003 (490 ml boca
English: 6) Restrain the calf and insert the nozzle of the metering pump into its mouth.
Croatian: 6) Obuzdajte tele i uvedite mu otvor pumpe u usta.
English: Boxes with a metering pump:
Croatian: Kutije sa mjernom pumpom:
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVETI ILI OGRANIČENJA U
English: - People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.
Croatian: - Osobe preosjetljive na djelatnu tvar ili na bilo koju od pomoćnih tvari trebaju izbjegavati kontakt s veterinarsko-medicinskim proizvodom.
English: For lighter or heavier animals, a precise calculation should be performed (2 ml/10 kg bw).
Croatian: Za životinje manje ili veće težine treba precizno izračunati dozu (2 ml / 10 kg t.m.)
English: The animals should receive enough colostrum according to good breeding practice.
Croatian: Životinje trebaju dobiti dovoljnu količinu kolostruma, bez obzira na postojeće stanje.
English: In cases where the dosing pump is unsuitable for the weight of animals to be treated, either a syringe or any other appropriate device can be used.
Croatian: U slučajevima, kada veličina pumpe ne odgovara težini životinje kojoj se primjenjuje, može se uporabiti brizgaljka ili bilo kakav drugi prikladni uređaj za primjenu kroz usta.
English: Amounts to be administered and administration route
Croatian: 4.9 Količine koje se primjenjuju i put primjene