FrancophonIA/ELRC3.0 huggingface dataset:
English: • Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
Slovenian: • Zdravilo Ovaleap je s sočasnim zdravljenjem s humanim horionskim gonadotropinom (hCG) indicirano za stimulacijo spermatogeneze pri moških, ki imajo prirojen ali pridobljen hipogonadotropni hipogonadizem.
English: In clinical studies comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table 3 below) and in ovulation induction, follitropin alfa was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.
Slovenian: V kliničnih študijah so primerjali r-hFSH (folitropin alfa) in urinarni FSH pri ART (glejte preglednico 3 spodaj) ter pri indukciji ovulacije.
English: • Sacs of fluid within the ovaries (ovarian cysts) Common (may affect up to 1 in 10 people)
Slovenian: • votlinice s tekočino v jajčnikih (ciste jajčnikov) Pogosti (pojavijo se lahko pri največ 1 od 10 bolnic)
English: The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Slovenian: Bolnici se priporoča spolni odnos na isti dan, ko je prejela hCG in naslednji dan.
English: The patients should be advised of the potential risk of multiple births before starting treatment.
Slovenian: Pred pričetkom zdravljenja morajo biti bolnice seznanjene s potencialnim tveganjem večplodnih porodov.
English: Ovaleap 450 IU/0.75 mL is available in packs containing 1 cartridge and 10 injection needles.
Slovenian: Zdravilo Ovaleap 450 i.e./0,75 ml je na voljo v pakiranjih, ki vsebujejo 1 vložek in 10 injekcijskih igel.
English: Ovaleap 900 IU/1.5 mL solution for injection EU/1/13/871/003
Slovenian: Ovaleap 900 i.e./1,5 ml raztopina za injiciranje EU/1/13/871/003
English: Ovaleap 450 IU/0.75 mL solution for injection EU/1/13/871/002
Slovenian: Ovaleap 450 i.e./0,75 ml raztopina za injiciranje EU/1/13/871/002
English: You must discard this medicine if it has not been used after 3 months.
Slovenian: Če se ne uporabi, je treba zdravilo po 3 mesecih zavreči.
English: Ovaleap 900 IU/1.5 mL is available in packs containing 1 cartridge and 20 injection needles.
Slovenian: Zdravilo Ovaleap 900 i.e./1,5 ml je na voljo v pakiranjih, ki vsebujejo 1 vložek in 20 injekcijskih igel.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARTRIDGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Birth defects
Slovenian: Prirojene napake
English: Once opened, the cartridge in-use in the pen may be stored for a maximum of 28 days.
Slovenian: Rok uporabnosti in pogoji shranjevanja po prvem odprtju zdravila Vložek v injekcijskem peresniku se lahko shranjuje največ 28 dni.
English: Ovaleap 300 IU/0.5 mL is available in packs containing 1 cartridge and 10 injection needles.
Slovenian: Zdravilo Ovaleap 300 i.e./0,5 ml je na voljo v pakiranjih, ki vsebujejo 1 vložek in 10 injekcijskih igel.
English: Posology
Slovenian: VLOŽEK
English: Ovaleap is designed for use in conjunction with the Ovaleap Pen only.
Slovenian: Zdravilo Ovaleap je oblikovano samo za uporabo v povezavi z injekcijskim peresnikom Ovaleap Pen.
English: The medicinal product must be discarded if it has not been used after 3 months.
Slovenian: Zdravilo, ki po 3 mesecih ni bilo uporabljeno, je treba zavreči.
English: Ovaleap 450 IU/0.75 mL solution for injection
Slovenian: Ovaleap 450 i.e./0,75 ml raztopina za injiciranje
English: 1 cartridge with 1.5 mL solution and 20 injection needles
Slovenian: 1 vložek z 1,5 ml raztopine in 20 injekcijskih igel
English: There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility treatment.
Slovenian: Pri ženskah, ki so bile vključene v več režimov zdravljenja neplodnosti, so poročali o novotvorbah na jajčnikih in drugih delih reprodukcijskega sistema, tako benignih kot malignih.
English: For the following cycle, your doctor will give you a higher starting dose of this medicine than before.
Slovenian: Za naslednji ciklus vam bo vaš zdravnik predpisal zdravljenje z večjim začetnim odmerkom tega zdravila kot v predhodnem ciklusu.
English: Ovaleap 450 IU/0.75 mL: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
Slovenian: - Ovaleap 450 i.e./0,75 ml: En vložek vsebuje 450 i.e. (kar ustreza 33 mikrogramom) folitropina alfa v 0,75 ml raztopine.
English: If after this period, the patient has not responded, the combination treatment may be continued; current clinical experience indicates that treatment for at least 18 months may be necessary to achieve spermatogenesis.
Slovenian: Sedanje klinične izkušnje kažejo, da je lahko za doseganje spermatogeneze potrebno vsaj 18 mesecev.
English: Ovaleap 900 IU/1.5 mL: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution.
Slovenian: - Ovaleap 900 i.e./1,5 ml: En vložek vsebuje 900 i.e. (kar ustreza 66 mikrogramom) folitropina alfa v 1,5 ml raztopine.
English: This side effect is common (may affect up to 1 in 10 people).
Slovenian: Ta neželeni učinek je pogost (prizadene lahko največ 1 od 10 bolnic).
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
Slovenian: Ovaleap 300 i.e./0,5 ml raztopina za injiciranje Ovaleap 450 i.e./0,75 ml raztopina za injiciranje Ovaleap 900 i.e./1,5 ml raztopina za injiciranje folitropin alfa
English: What Ovaleap is
Slovenian: Kaj je zdravilo Ovaleap
English: Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa.
Slovenian: En ml raztopine vsebuje 600 i.e. (kar ustreza 44 mikrogramom) folitropina alfa.
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..
Slovenian: Vložek (steklo tipa I) z gumijastim batom (bromobutilna guma) in zgibano zaporko (aluminij) s pregradno steno (bromobutilna guma), ki vsebuje 0,75 ml raztopine.
English: The cartridge in-use in the pen may be stored for a maximum of 28 days.
Slovenian: Odprt vložek v injekcijskem peresniku lahko shranjujete največ 28 dni.
English: Table 1: Adverse reactions in women System organ class
Slovenian: Preglednica 1: Neželeni učinki pri ženskah
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..
Slovenian: Vložek (steklo tipa I) z gumijastim batom (bromobutilna guma) in zgibano zaporko (aluminij) s pregradno steno (bromobutilna guma), ki vsebuje 1,5 ml raztopine.
English: If your body responds too strongly, your treatment with Ovaleap will be stopped and you will not be given any hCG [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Slovenian: Če pride do pretiranega odziva, je treba zdravljenje z zdravilom Ovaleap prekiniti in opustiti uporabo hCG [glejte tudi poglavje 2 "Sindrom hiperstimulacije jajčnikov (OHSS)"].
English: If your body responds too strongly, your treatment will be stopped and you will not be given any hCG [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Slovenian: Če pride do pretiranega odziva, je treba zdravljenje prekiniti in opustiti uporabo hCG [glejte tudi poglavje 2 "Sindrom hiperstimulacije jajčnikov (OHSS)"].
English: How to store Ovaleap
Slovenian: Shranjevanje zdravila Ovaleap
English: Ovaleap contains 10.0 mg per mL benzyl alcohol
Slovenian: Zdravilo Ovaleap vsebuje 10,0 mg benzilalkohola na 1 ml.
English: Ovaleap 900 IU/1.5 mL solution for injection
Slovenian: Ovaleap 900 i.e./1,5 ml raztopina za injiciranje
English: 1 cartridge with 0.5 mL solution and 10 injection needles
Slovenian: 1 vložek z 0,5 ml raztopine in 10 injekcijskih igel
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.
Slovenian: Vložek (steklo tipa I) z gumijastim batom (bromobutilna guma) in zgibano zaporko (aluminij) s pregradno steno (bromobutilna guma), ki vsebuje 0,5 ml raztopine.
English: What Ovaleap is used for
Slovenian: Za kaj uporabljamo zdravilo Ovaleap
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovaleap 450 IU/0.75 mL injection follitropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ovaleap 450 i.e./0,75 ml injekcija folitropin alfa s.c.
English: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution for injection.
Slovenian: En vložek vsebuje 900 i.e. (kar ustreza 66 mikrogramom) folitropina alfa v 1,5 ml raztopine za injiciranje.
English: The instructions for use of the pen will be provided together with the Ovaleap Pen.
Slovenian: Navodila za uporabo injekcijskega peresnika bodo priložena injekcijskemu peresniku Ovaleap Pen.
English: 1 cartridge with 0.75 mL solution and 10 injection needles
Slovenian: 1 vložek z 0,75 ml raztopine in 10 injekcijskih igel
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.
Slovenian: Ko je dosežen optimalen odziv, se mora dati eno samo injekcijo 250 mikrogramov rekombinantnega humanega horionskega gonadotropina alfa (r-hCG) ali 5.000 i.e. do 10.000 i.e. hCG-ja, 24 do 48 ur po zadnji injekciji folitropina alfa.
English: Ovaleap 300 IU/0.5 mL solution for injection
Slovenian: Ovaleap 300 i.e./0,5 ml raztopina za injiciranje
English: You are more likely to have a pregnancy outside the womb (an ectopic pregnancy) than the average woman when undergoing assisted reproductive technology and if you have damaged fallopian tubes.
Slovenian: Pri tehnikah asistirane reprodukcije in pri poškodovanih jajcevodih je verjetnost ugnezditve zarodka zunaj maternice (zunajmaternične nosečnosti) višja kot pri povprečnih ženskah.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/871/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/871/002
English: Nevertheless one could expect Ovarian Hyper-Stimulation Syndrome (OHSS) to occur, which is described in section 4 under “Serious side effects in women".
Slovenian: Če ste uporabili večji odmerek zdravila Ovaleap, kot bi smeli Učinki jemanja prevelike količine zdravila Ovaleap niso znani, lahko pa pričakujemo pojav sindroma hiperstimulacije jajčnikov (OHSS), ki je opisan v poglavju 4 "Resni neželeni učinki pri ženskah".
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.
Slovenian: Ena sama injekcija 250 mikrogramov r-hCG ali 5.000 i.e. do 10.000 i.e. hCG se injicira 24 do 48 ur po zadnji injekciji folitropina alfa, za sprožitev končnega zorenja foliklov.
English: - any condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause), fibroid tumours of the womb or malformed reproductive organs.
Slovenian: • če ste ženska in imate: - povečane jajčnike ali votlinice s tekočino znotraj jajčnikov (ciste jajčnikov) neznanega izvora; - ginekološke krvavitve nepojasnjenega vzroka; - rak jajčnika, maternice ali dojke; - kakršno koli stanje, ki običajno onemogoča normalno nosečnost, kot je odpoved jajčnikov (prezgodnja menopavza), fibroidni tumorji v maternici ali malformacija spolnih organov.
English: Ovaleap 300 IU/0.5 mL: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution.
Slovenian: - Ovaleap 300 i.e./0,5 ml: En vložek vsebuje 300 i.e. (kar ustreza 22 mikrogramom) folitropina alfa v 0,5 ml raztopine.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/871/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/871/001
English: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution.
Slovenian: En vložek vsebuje 900 i.e. (kar ustreza 66 mikrogramom) folitropina alfa v 1,5 ml raztopine.
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.
Slovenian: Ko je dosežen optimalen odziv, se injicira ena sama injekcija 250 mikrogramov r-hCG ali 5.000 i.e. do 10.000 i.e. hCGja, 24 do 48 ur po zadnji injekciji folitropina alfa in lutropina alfa.
English: There is no relevant use of follitropin alfa in the elderly population.
Slovenian: Folitropin alfa ni namenjen za uporabo pri starejših bolnikih.
English: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution for injection.
Slovenian: En vložek vsebuje 300 i.e. (kar ustreza 22 mikrogramom) folitropina alfa v 0,5 ml raztopine za injiciranje.
English: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution for injection.
Slovenian: En vložek vsebuje 450 i.e. (kar ustreza 33 mikrogramom) folitropina alfa v 0,75 ml raztopine za injiciranje.
English: This medicine also contains 0.02 mg per mL of benzalkonium chloride and 10.0 mg per mL of benzyl alcohol.
Slovenian: Zdravilo Ovaleap vsebuje 0,02 mg benzalkonijevega klorida na 1 ml. Vsebnost benzilalkohola
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/871/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/871/003
English: MARKETING AUTHORISATION NUMBER(S) Ovaleap 300 IU/0.5 mL solution for injection EU/1/13/871/001
Slovenian: Ovaleap 300 i.e./0,5 ml raztopina za injiciranje 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.
Slovenian: Ena injekcija bo vsebovala 250 mikrogramov r-hCG ali 5.000 do 10.000 i.e. hCG, 24 do 48 ur po zadnji injekciji zdravila Ovaleap.
English: You are more likely to have a miscarriage than the average woman when undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs.
Slovenian: Pri tehnikah asistirane reprodukcije ali stimulacije jajčnikov za tvorbo jajčec je verjetnost splava večja kot pri povprečnih ženskah.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovaleap 900 IU/1.5 mL injection follitropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ovaleap 900 i.e./1,5 ml injekcija folitropin alfa s.c.
English: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution.
Slovenian: En vložek vsebuje 300 i.e. (kar ustreza 22 mikrogramom) folitropina alfa v 0,5 ml raztopine.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovaleap 300 IU/0.5 mL injection follitropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ovaleap 300 i.e./0,5 ml injekcija folitropin alfa s.c.
English: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
Slovenian: En vložek vsebuje 450 i.e. (kar ustreza 33 mikrogramom) folitropina alfa v 0,75 ml raztopine.
English: Gynaecomastia, varicocele
Slovenian: Motnje reprodukcije in dojk pogosti ginekomastija, varikokela
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 900 IU/1.5 mL solution for injection follitropin alfa
Slovenian: Ovaleap 900 i.e./1,5 ml raztopina za injiciranje folitropin alfa
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJI OVOJNINI
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 450 IU/0.75 mL solution for injection follitropin alfa
Slovenian: Ovaleap 450 i.e./0,75 ml raztopina za injiciranje folitropin alfa
English: BATCH NUMBER Batch
Slovenian: ŠTEVILKA SERIJE LOT
English: Immune system disorders
Slovenian: Organski sistem
English: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti reakcije na mestu injiciranja (npr. bolečina, eritem, hematom, oteklina in/ali razdraženost na mestu injiciranja)
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 300 IU/0.5 mL solution for injection follitropin alfa
Slovenian: Ovaleap 300 i.e./0,5 ml raztopina za injiciranje folitropin alfa
English: OTHER
Slovenian: LOT
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zelo redki ponovni izbruhi ali poslabšanje astme
English: Please talk to your doctor as soon as you realise that you forgot a dose.
Slovenian: Takoj ko opazite, da ste odmerek izpustili, se pogovorite s svojim zdravnikom.
English: Strength Pharmaceutical form Route of administration
Slovenian: Jakost Farmacevtska oblika Pot uporabe
English: The consecutive treatment should be administered at the same time each day.
Slovenian: Zdravljenje je potrebno opraviti vsak dan ob istem času.
English: - Wash hands after use.
Slovenian: - Po uporabi si umijte roke.
English: Do not use on an empty stomach.
Slovenian: Ne uporabljajte na prazen želodec.
English: ATCvet code: QP51AX08.
Slovenian: Oznaka ATC vet: QP51AX08.
English: Halofuginone
Slovenian: Halofuginon
English: Rehydration may be necessary.
Slovenian: Včasih je potrebna rehidracija.
English: The time necessary to obtain the maximum concentration Tmax is 11 hours.
Slovenian: Čas do največje koncentracije (Tmax) je 11 ur.
English: Not for use in animals from which milk is produced for human consumption.
Slovenian: Ni za uporabo pri živalih katerih mleko se uporablja za prehrano ljudi.
English: The product should not enter watercourses as this may be dangerous for fish and other aquatic organisms.
Slovenian: Zdravilo ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.
English: The maximum concentration in plasma Cmax is 4 ng/ml.
Slovenian: Največja koncentracija v plazmi (Cmax) je 4 ng/ml.
English: - In case of skin and eye contact wash the exposed area thoroughly with clean water.
Slovenian: - V primeru stika s kožo ali očmi, izpostavljeno mesto temeljito sperite s čisto vodo.
English: The animals should receive enough colostrum according to good breeding practice.
Slovenian: Živali morajo prejeti dovolj veliko količino kolostruma, v skladu z dobro vzrejno prakso.
English: Do not use in cases of diarrhoea established for more than 24 hours and in weak animals.
Slovenian: Ne uporabite pri driskah, ki trajajo dlje kot 24 ur in pri oslabelih živalih.
English: In both cases, the reduction of oocysts excretion has been demonstrated.
Slovenian: V obeh primerih je bilo dokazano zmanjšanje števila oocist v izločkih.
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.
Slovenian: Po zdravljenju prvega teleta, morajo biti sistematično zdravljena tudi vsa naslednja novorojena teleta, vse dokler obstaja tveganje za pojav driske povzročene s C. Parvum.
English: The terminal elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral administration.
Slovenian: Končna razpolovna doba izločanja je 11,7 ur po intravenskem dajanju in 30,84 ur po enkratnem peroralnem dajanju.
English: The product is mainly excreted in the urine.
Slovenian: Zdravilo se pretežno izloča z urinom.
English: - Wear protective gloves while handling the product.
Slovenian: - Pri ravnanju z zdravilom nosite zaščitne rokavice.
English: Highest values have been found in the liver and the kidney.
Slovenian: Največje vrednosti so izmerili v jetrih in ledvicah.
English: The apparent volume of distribution is 10 l/kg.
Slovenian: Navidezna porazdelitev prostornine je 10 l/kg.
English: - Repetitive contact with the product may lead to skin allergies.
Slovenian: - Večkratni stik z zdravilom lahko povzroči kožne alergije.
English: The frequency of adverse reactions is defined using the following convention: - Very common (more than 1 in 10 animals treated displaying adverse reactions) - 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).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: As symptoms of toxicity may occur at twice the therapeutic dose, it is necessary to apply the recommended dosage strictly.
Slovenian: Ker se po dvakratnem terapevtskem odmerku lahko pojavijo znaki toksičnosti, morate natančno upoštevati priporočeno odmerjanje.
English: If product remains in the bottle, leave the pump attached until further use.
Slovenian: Če v plastenki ostane zdravilo, pustite črpalko pritrjeno do naslednje uporabe.
English: Administration should start in the first 24 to 48 hours of age.
Slovenian: Zdravilo začnemo dajati v prvih 24. do 48. urah po rojstvu.
English: Halofuginone lactate is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections.
Slovenian: Halofuginon laktat je sol, katere antiprotozoični učinek in učinkovitost proti Cryprosporidium parvum so dokazali tako in vitro kot pri umetnih in naravnih okužbah.
English: It is mainly active on the free stages of the parasite (sporozoïte, merozoïte).
Slovenian: Učinkovita je predvsem proti prostim oblikam parazita (sporozoitom, merozoitom).
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.
Slovenian: Koncentraciji, potrebni za 50- in 90-odstotno zaviranje parazitov v in vitro preskusu sta: IC50 < 0,1 µg/ml in IC90 4,5 µg/ml.
English: United Kingdom Virbac Ltd,
Slovenian: Virbac Ltd,
English: Clear yellow solution.
Slovenian: Bistra, rumena raztopina.
English: Meat and offal: 13 days.
Slovenian: Meso in organi: 13 dni.
English: 4 to 12 ml pump
Slovenian: 4 do 12 ml črpalka
English: Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration.
Slovenian: Simptomi toksičnosti vključujejo drisko, vidne sledi krvi v blatu, zmanjšano uživanje mleka, dehidracijo, apatijo in prostracijo (huda izčrpanost).
English: For the full list of excipients, see section 6.1.
Slovenian: 0,03 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Carton with bottle only Refill
Slovenian: Karton s samo plastenko Ponovno polnjenje
English: Disposal : read package leaflet.
Slovenian: Odstranjevanje: preberite navodilo za uporabo.
English: Tartrazine (E 102)
Slovenian: Tartrazin (E 102)
English: The bioavailability of the drug in the calf following single oral administration is about 80%.
Slovenian: Biološka uporabnost zdravila je pri teletih po enkratnem peroralnem dajanju približno 80%.
English: Halofuginone Halofuginone Bovine 10 μg/kg
Slovenian: Halofuginon Halofuginon Govedo 10 μg/kg 25 μg/kg
English: Halofuginone (as lactate salt)
Slovenian: halofuginon (v obliki soli laktata)
English: Benzoic acid (E 210)
Slovenian: Benzojska kislina (E 210)
English: EXP {month/year} Once opened use within 6 months.
Slovenian: EXP {mesec/leto} Odprto zdravilo uporabite v 6 mesecih.
English: 8) Continue using until the bottle is empty.
Slovenian: 8) Nadaljujte z uporabo, dokler plastenka ni prazna.