FrancophonIA/ELRC3.0 huggingface dataset:
English: Tracleer 125 mg tablets bosentan
Croatian: Tracleer 125 mg tablete bosentan
English: Do not swallow the desiccant
Croatian: Nemojte progutati sredstvo za sušenje
English: Lopinavir+ritonavir (and other ritonavir-boosted protease inhibitors): Co-administration of bosentan 125 mg twice daily and lopinavir+ritonavir 400+100 mg twice daily for 9.5 days in healthy volunteers resulted in initial trough plasma concentrations of bosentan that were approximately 48-fold higher than those measured after bosentan administered alone.
Croatian: 125 mg dvaput dnevno i lopinavira 400 mg + ritonavira 100 mg dvaput dnevno kroz 9,5 dana kod zdravih dobrovoljaca rezultirala je početnim najnižim koncentracijama bosentana u plazmi koje su bile približno 48 puta više od onih izmjerenih nakon primjene bosentana samostalno.
English: Laboratory abnormalities
Croatian: Abnormalne vrijednosti laboratorijskih nalaza
English: Simvastatin: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of simvastatin (a CYP3A4 substrate) and its active β-hydroxy acid metabolite by 34% and 46%, respectively.
Croatian: Simvastatin: istodobna primjena bosentana 125 mg dvaput dnevno tijekom 5 dana dovela je do smanjenja koncentracija simvastatina u plazmi (susptrat CYP3A4) te njegovog aktivnog β hidroksikiselinskog metabolita za 34%, odnosno 46%.
English: Tracleer 62.5 mg tablets bosentan
Croatian: Tracleer 62,5 mg tablete bosentan
English: Tracleer 62.5 mg film-coated tablets Tracleer 125 mg film-coated tablets
Croatian: Tracleer 62,5 mg filmom obložene tablete Tracleer 125 mg filmom obložene tablete
English: In this open-label randomised study with the bosentan 32 mg dispersible tablet formulation, 64 children with stable PAH from 3 months to 11 years of age were randomised to 24 weeks' bosentan treatment 2 mg/kg twice daily (n = 33) or 2 mg/kg three times daily (n = 31).
Croatian: 64 djece sa stabilnim PAH-om u dobi od 3 mjeseca do 11 godina randomizirano je u skupine liječenja bosentanom u dozi od 2 mg/kg dvaput na dan (n = 33) ili u dozi od 2 mg/kg triput na dan (n = 31)
English: To remove the dispersible tablet:
Croatian: Kako biste izvadili tabletu za oralnu suspenziju:
English: Birth control based on hormones - such as oral contraceptives or birth control pills, hormone injections, implants, or birth control skin patches don't reliably prevent pregnancy in women who are taking Tracleer.
Croatian: Metode hormonske kontracepcije primijenjene oralno, u obliku injekcija, implantata ili flastera nisu pouzdane u žena koje uzimaju Tracleer.
English: No dose adjustment is required in patients with renal impairment.
Croatian: Prilagodba doze nije potrebna kod bolesnika s oštećenjem funkcije bubrega.
English: After 4 weeks of bosentan 62.5 mg twice daily, the maintenance dose studied in both these studies was
Croatian: Nakon 4 tjedna primanja bosentana 62,5 mg dvaput dnevno, doza održavanja bila je 125
English: Package leaflet: Information for the user Tracleer 32 mg dispersible tablets
Croatian: Uputa o lijeku: Informacije za korisnika Tracleer 32 mg tablete za oralnu suspenziju bosentan
English: The dispersible tablet is contained in a child-proof blister.
Croatian: Tableta za oralnu suspenziju nalazi se u blisteru sigurnom za djecu.
English: The impact of moderately impaired liver function (Child-Pugh class B) on the pharmacokinetics of bosentan and its primary metabolite Ro 48-5033 was investigated in a study including 5 patients with pulmonary hypertension associated with portal hypertension and Child-Pugh class B hepatic impairment, and 3 patients with PAH from other causes and normal liver function.
Croatian: Ro 48-5033 istraženo je u ispitivanju koje je uključivalo 5 bolesnika sa plućnom hipertenzijom povezanom s portalnom hipertenzijom i jetrena oštećenja Child-Pugh stadija B
English: The NOAEL was 21 times (at Day 21 post partum) and 2.3 times (Day 69 post partum) the human therapeutic exposure, respectively.
Croatian: No observed adverse effect level) je bila 21 put (na 21. postpartalni dan) odnosno 2,3 puta (na 69.
English: In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2,486 patients were treated with bosentan at daily doses ranging from 100 mg to 2000 mg and 1,838 patients were treated with placebo.
Croatian: bolesnika dobivalo je bosentan u dnevnim dozama od 100 mg do 2000 mg, a 1838 bolesnika dobivalo je placebo.
English: Cartons contain 56 film-coated tablets (Tracleer 62.5 mg film-coated tablets).
Croatian: Kutije sadrže 56 filmom obloženih tableta (Tracleer 62,5 mg filmom obložene tablete).
English: Mar ______
Croatian: Ožujak ______
English: Cartons contain 56 film-coated tablets (Tracleer 125 mg film-coated tablets).
Croatian: Kutije sadrže 56 filmom obloženih tableta (Tracleer 125 mg filmom obložene tablete).
English: Tracleer 125 mg film-coated tablets Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side.
Croatian: Tracleer 125 mg filmom obložene tablete Narančasto-bijele, ovalne, bikonveksne filmom obložene tablete, s oznakom „125“ na jednoj strani.
English: At steady state, AUCτ was 6,165 ng·h/mL (CV: 133%, n = 7), which is similar to the exposure observed in adult PAH patients receiving 125 mg twice daily and taking into account a blood/plasma distribution ratio of 0.6.
Croatian: 7), što je slično izloženosti zabilježenoj u odraslih bolesnika s PAH-om koji su primali 125 mg dvaput dnevno i uzimajući u obzir omjer distribucije u krvi i plazmi od 0,6.
English: A pooled analysis of uncontrolled paediatric studies conducted in PAH with the bosentan 32 mg dispersible tablet formulation (FUTURE 1/2, FUTURE 3/Extension) included a total of 100 children treated with bosentan 2 mg/kg twice daily (n = 33), 2 mg/kg three times daily (n = 31), or 4 mg/kg twice daily (n = 36).
Croatian: 3/produžetak) uključila je ukupno 100 djece liječene bosentanom 2 mg/kg dvaput dnevno (n = 33), 2 mg/kg triput dnevno (n = 31) ili 4 mg/kg dvaput dnevno (n = 36).
English: Background treatments for systemic sclerosis and digital ulcers were permitted if they remained constant for at least 1 month prior to the start of treatment and during the double-blind study period.
Croatian: Dodatni lijekovi za sistemsku sklerozu i ulceracije prstiju bili su dozvoljeni ako su uzimani najmanje 1
English: However, Tracleer can induce hypotension (decrease of your blood pressure) which can make you feel dizzy, affect your vision and affect your ability to drive and use machines.
Croatian: Ipak, Tracleer može uzrokovati hipotenziju (pad krvnog tlaka) što može uzrokovati osjećaj omaglice,
English: In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo).
Croatian: 4) ukupno je 13 novorođenčadi liječeno bosentanom u obliku tablete za oralnu suspenziju u dozi od 2 mg/kg dvaput dnevno (8 bolesnika primalo je placebo).
English: 112 film-coated tablets (Tracleer 62.5 mg film-coated tablets).
Croatian: filmom obloženih tableta (Tracleer 62,5 mg filmom obložene tablete).
English: Cartons contain 56 dispersible tablets.
Croatian: Kutije sadrže 56 tableta za oralnu suspenziju.
English: Tracleer 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
Croatian: Tracleer 62,5 mg filmom obložene tablete su narančasto-bijele, okrugle filmom obložene tablete s oznakom „62,5“ na jednoj strani.
English: Tracleer 62.5 mg film-coated tablets bosentan
Croatian: Tracleer 62,5 mg filmom obložene tablete bosentan
English: • The median time to complete weaning from mechanical ventilation was 10.8 days (95% CLs 3.21, 12.21 days) on bosentan and 8.6 days (95% CLs 3.71, 9.66 days) on placebo (p = 0.24).
Croatian: • Medijan vremena do potpunog odvikavanja od iNO bio je 3,7 dana (95% granice pouzdanosti [CL] 1,17; 6,95) uz bosentan i 2,9 dana (95% CL 1,26; 4,23) uz placebo (p = 0,34).
English: Of the 7 patients who deteriorated at week 8, 3 improved at week 12/16 and 4 deteriorated compared with baseline.
Croatian: 3 došlo je do poboljšanja nakon 12/16 tjedana, a u 4 je došlo do pogoršanja.
English: Tracleer 62.5 mg film-coated tablets Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side.
Croatian: Tracleer 62,5 mg filmom obložene tablete Narančasto-bijele, okrugle, bikonveksne filmom obložene tablete, s oznakom „62,5“ na jednoj strani.
English: In the patients with Child-Pugh class B liver impairment, the mean (95% CI) steady-state AUC of bosentan was 360 (212613) ng⋅h/mL, i.e., 4.7 times higher, and the mean (95% CI) AUC of the active metabolite Ro 48-5033 was 106 (58.4-192) ng⋅h/mL, i.e., 12.4 times higher than in the patients with normal liver function (bosentan: mean [95% CI] AUC: 76.1 [9.07-638] ng⋅h/mL; Ro 48-5033: mean [95% CI] AUC 8.57 [1.28-57.2] ng⋅h/ml).
Croatian: Ro 48-5033 bio je 106 (58,4-192) ng⋅h/ml, tj. 12,4 puta viši nego kod bolesnika s normalnom funkcijom jetre (bosentan: srednji [95% CI] AUC: 76,1 [9,07-638] ng⋅h/ml; Ro 48-5033:
English: Do not store above 25 °C
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25°C
English: Tracleer 125 mg film-coated tablets bosentan
Croatian: Tracleer 125 mg filmom obložene tablete bosentan
English: Tracleer 32 mg dispersible tablets
Croatian: Tracleer 32 mg tablete za oralnu suspenziju
English: Tracleer 32 mg dispersible tablets bosentan
Croatian: Tracleer 32 mg tablete za oralnu suspenziju bosentan
English: Jul ______
Croatian: Listopad _____
English: Based on the findings in studies BREATHE-3, FUTURE 1, and FUTURE-3, it appears that the exposure to bosentan reaches a plateau at lower doses in paediatric patients than in adults, and that doses higher than 2 mg/kg twice daily (4 mg/kg twice daily or 2 mg/kg three times daily) will not result in greater exposure to bosentan in paediatric patients.
Croatian: Na osnovi nalaza u studijama BREATHE-3, FUTURE 1 i FUTURE-3 pokazalo se da izloženost bosentanu doseže plato kod nižih doza u pedijatrijskih bolesnika nego u odraslih te da doze više od 2
English: At study entry, patients were treated with PAH medications (most frequently phosphodiesterase type-5 inhibitor [sildenafil] alone [35.9%], bosentan alone [10.9%], and a combination of bosentan, iloprost, and sildenafil [10.9%]) and continued their PAH treatment during the study.
Croatian: [sildenafil] u monoterapiji [35,9%], bosentanom u monoterapiji [10,9%] i kombinacijom bosentana,
English: You need to use a barrier form of birth control - like a condom, diaphragm or vaginal sponge - in addition to any of these kinds of hormonal birth control.
Croatian: dijafragma ili kontracepcijska spužva uz bilo koju od navedenih vrsta hormonalne kontracepcije.
English: > 3 and ≤ 5 × ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue Tracleer, possibly at a reduced dose, or to stop Tracleer administration (see section 4.2).
Croatian: > 3 i ≤ 5 × GGN Nalaz treba potvrditi drugim testom jetrene funkcije; ako je potvrđen, donijeti odluku za svakog bolesnika ponaosob da li nastaviti liječenje
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Croatian: Plućna arterijska hipertenzija Liječenje smije započeti i nadzirati jedino liječnik s iskustvom u liječenju PAH-a.
English: Tracleer 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side.
Croatian: Tracleer 125 mg filmom obložene tablete su narančasto bijele, okrugle filmom obložene tablete s oznakom „125“ na jednoj strani.
English: Each dispersible tablet contains 32 mg bosentan (as monohydrate)
Croatian: Jedna tableta za oralnu suspenziju sadrži 32 mg bosentana (u obliku bosentan hidrata)
English: Liver test abnormalities
Croatian: Abnormalne vrijednosti testova jetrene funkcije
English: Each dispersible tablet contains 32 mg bosentan (as monohydrate).
Croatian: Jedna tableta za oralnu suspenziju sadrži 32 mg bosentana (u obliku bosentan hidrata).
English: Feb ______
Croatian: Svibanj ______
English: How to store Tracleer
Croatian: Moguće nuspojave Kako čuvati Tracleer
English: These will be done every month for the first 4 months of treatment, then every 3 months after that, as patients taking Tracleer may get anaemia.
Croatian: S obzirom na to da bolesnici koji uzimaju Tracleer mogu dobiti anemiju, ti nalazi provode se svakog mjeseca tijekom prva 4 mjeseca liječenja, a potom svaka 3 mjeseca.
English: Aug ______
Croatian: Travanj ______
English: Each tablet contains 125 mg of bosentan (as monohydrate).
Croatian: Jedna tableta za oralnu suspenziju sadrži 125 mg bosentana (u obliku bosentan hidrata).
English: • Hypersensitivity reactions (including skin inflammation, itching and rash)
Croatian: • Reakcije preosjetljivosti (uključujući upalu, svrbež i osip na koži) • Gastroezofagealna refluksna bolest (vraćanje kiselog sadržaja iz želuca)
English: Safety and tolerability of bosentan was investigated in an exploratory, uncontrolled 12-week study in 11 patients with pulmonary hypertension secondary to severe COPD (stage III of GOLD classification).
Croatian: Sigurnost i podnošljivost bosentana ispitana je u eksploratornij, nekontroliranoj 12-tjednoj studiji na
English: Efficacy in adult patients with pulmonary arterial hypertension Two randomised, double-blind, multi-centre, placebo-controlled studies have been conducted in 32 (study AC-052-351) and 213 (study AC-052-352 [BREATHE-1]) adult patients with WHO functional class III-IV PAH (primary pulmonary hypertension or pulmonary hypertension secondary mainly to scleroderma).
Croatian: 32 (studija AC-052-351) i 213 (studija AC-052-352 [BREATHE-1]) odrasla bolesnika s PAH-om
English: A careful benefit/risk assessment should be made, taking into consideration the liver toxicity of bosentan (see sections 4.4 and 4.8).
Croatian: Treba napraviti pažljivu procjenu koristi i rizika, uzimajući u obzir da je bosentan toksičan za jetru
English: Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Silica colloidal anhydrous Tartaric acid
Croatian: Drugi sastojci su mikrokristalična celuloza, kalcijev hidrogenfosfat, bezvodni, karmelozanatrij,
English: Liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals for the duration of treatment with Tracleer.
Croatian: Prije početka liječenja i svaki mjesec tijekom liječenja Tracleerom treba izmjeriti vrijednosti jetrenih aminotransferaza.
English: Jun ______
Croatian: Rujan _____
English: Jan ______
Croatian: Studeni _____
English: • Gastrooesophageal reflux disease (acid reflux)
Croatian: • Ciroza (stvaranje ožiljaka) jetre, zatajenje jetre (teški poremećaj funkcije jetre)
English: In the adult placebo-controlled studies, a decrease in haemoglobin concentration to below 10 g/dL from baseline was reported in 8.0% of bosentan-treated patients and 3.9% of placebo-treated patients (see section 4.4).
Croatian: g/dl od početne vrijednosti prijavljeno je kod 8,0% bolesnika koji su dobivali bosentan i 3,9%
English: 164 ng·h/mL, n = 11).
Croatian: U stanju dinamičke ravnoteže AUCτ je bila 6165 ng•h/mL (CV: 133%, n =
English: Тел.
Croatian: Vas.
English: Re-introduction of treatment
Croatian: Učinci liječenja
English: Slovak Republic Actavis Group PTC ehf Reykjavikurvegi 76-78
Croatian: Češka Republika Actavis Group PTC ehf Reykjavikurvegi 76-78
English: Perlinring 0,120 mg/0,015 mg pro 24 Stunden - Vaginalring
Croatian: Perlinring 0,120 mg/0,015 mg pro 24 StundenVaginalring
English: EU/2/19/239/001 Baycox Iron
Croatian: EU/2/19/239/001 Baycox Iron 36 mg/ml / 182 mg/mL
English: Piglets
Croatian: Karencija
English: Vial (glass) 100 ml
Croatian: 100 ml
English: Meat and offal: 53 days
Croatian: 53 dana.
English: Intramuscular use
Croatian: Intramuskularna injekcija
English: Each ml contains:
Croatian: Svaki ml sadržava:
English: Date of first authorisation: 09/12/2015
Croatian: Datum prvog odobrenja: 09/12/2015
English: More than 74% of cabergoline is bound to plasma protein.
Croatian: Više od 74% kabergolina je vezano za proteine plazme.
English: Velactis reduces milk production.
Croatian: Velactis smanjuje lučenje mlijeka.
English: Meat and offal: 23 days
Croatian: Meso i jestive iznutrice: 23 dana
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara ili ljekarnika kako odlagati lijekove koji vam više nisu potrebni.
English: Prolactin inhibitor
Croatian: inhibitor prolaktina
English: Approximately 66% of the administered dose is eliminated by faeces.
Croatian: Približno 66% primijenjene doze eliminira se fecesom.
English: This veterinary medicinal product does not require any special storage condition.
Croatian: Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne uvjete čuvanja.
English: The active substance in Velactis is cabergoline, an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar u Velactisu je kabergolin, dozvoljena tvar kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010:
English: The veterinary medicinal product may cause skin sensitization.
Croatian: Veterinarsko-medicinski proizvod može izazvati senzibilizaciju kože.
English: Do not use after the expiry date which is stated on the carton after EXP.
Croatian: Ne koristiti nakon isteka roka valjanosti naznačenog na kutiji poslije EXP.
English: This was observed following 1.5-2 times of the recommended dose and was more pronounced at higher doses.
Croatian: To je uočeno nakon primjene doza 1,5-2 puta većih od preporučene i bilo je izraženije pri većim dozama.
English: (There are no data on pregnancy outcome in humans following injection of cabergoline, but studies in laboratory animals have shown a risk for embryonic death following repeat oral exposure to cabergoline.)
Croatian: (Nema podataka o ishodu trudnoće u ljudi nakon injiciranja kabergolina, ali su ispitivanja na laboratorijskim životinjama pokazala da postoji rizik od smrti embrija nakon ponovljene peroralne izloženosti kabergolinu.)
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 are 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 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.
English: Urine is the second pathway of elimination.
Croatian: Sekundarni put eliminacije je urin.
English: Velactis should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Croatian: Velactis se ne smije se odlagati u otvorene vode jer to može biti opasno za ribe i druge vodene organizme.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije http://www.ema.europa.eu
English: Studies in laboratory animals have shown a risk for embryonic death following repeat oral exposure to cabergoline.
Croatian: Ispitivanja na laboratorijskim životinjama pokazala su da postoji rizik od smrti embrija nakon ponovljene peroralne izloženosti kabergolinu.
English: Shelf-life after first opening the immediate packaging: 28 days.
Croatian: Rok trajanja poslije prvog otvaranja unutarnjeg pakovanja: 28 dana.
English: Cabergoline is rapidly metabolized principally by liver, and is eliminated with a mean half-life of about 20 h.
Croatian: Kabergolin se brzo metabolizira uglavnom u jetri i eliminira se uz srednju vrijednost poluživota od otprilike 20 sati.
English: Pharmacotherapeutic group: Other gynaecologicals, prolactin inhibitors, cabergoline ATCvet code: QG02CB03
Croatian: Farmakoterapijska grupa: Ostali ginekološki pripravci, inhibitori prolaktina, kabergolin ATCvet kod: QG02CB03
English: If you notice any serious effects or any other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP, molimo obavijestite svog veterinara.
English: Fatal meteorism has been observed in a single cow following a second administration of 5 times the recommended dose.
Croatian: Fatalni meteorizam je uočen kod jedne krave nakon druge primjene doze 5 puta veće od preporučene.
English: Normal aseptic procedures for administration of an intramuscular injection should be followed.
Croatian: Treba slijediti uobičajene aseptične postupke za primjenu intramuskularne injekcije.
English: This could theoretically decrease the metabolisation of cabergoline, and prolong its persistence in plasma from cows treated concomitantly with Velactis and such products.
Croatian: To bi teoretski moglo usporiti metabolizam kabergolina te produljiti njegovo zadržavanje u plazmi kod krava koje su istovremeno liječene Velactisom i takvim proizvodima.
English: In the absence of data on pregnancy outcome in humans following injection of cabergoline, pregnant women and women attempting to conceive should avoid contact with the product.
Croatian: U nedostatku podataka o ishodu trudnoće u ljudi nakon injiciranja kabergolina, trudnice i žene koje pokušavaju začeti trebaju izbjegavati doticaj s proizvodom.
English: Overdose (symptoms, emergency procedures, antidotes), if necessary Overdoses resulted in some cases in slight and transient decrease of appetite.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Predoziranje je u nekim slučajevima uzrokovalo blago i prolazno smanjenje apetita.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/192/001-004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/15/192/001-004
English: Only use a dry sterile needle and avoid the introduction of humidity/water during use.
Croatian: Koristite samo suhu sterilnu iglu kako biste izbjegli unos vlage/vode tijekom primjene.
English: TARGET SPECIES Cattle (dairy cows)
Croatian: CILJNE VRSTE ŽIVOTINJA Goveda (muzne krave)
English: Cattle (dairy cows)
Croatian: Goveda (muzne krave).
English: Excipients: For the full list of excipients, see section 6.1
Croatian: Pomoćne tvari: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Meat and offal: 23 days Milk: - Zero hours after calving when the dry period length is 32 days or more.
Croatian: Meso i jestive iznutrice: 23 dana Mlijeko: - Nula sati nakon telenja ako je suhostaj trajao 32 dana ili dulje.
English: Administer the veterinary medicinal product with caution to avoid self-injection.
Croatian: Veterinarsko-medicinski proizvod primjenjujte oprezno kako biste izbjegli samoinjiciranje.
English: The product should be injected within 4 hours after the last milking.
Croatian: Proizvod treba injicirati unutar 4 sata nakon zadnje mužnje.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use
Croatian: POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO Pročitati uputu o VMP prije primjene
English: Three consecutive administrations of 1, 3 or 5 times the recommended dose may result in transient and reversible slight elevation of plasma glucose levels.
Croatian: Tri uzastopne primjene doze 1, 3 ili 5 puta veće od preporučene može dovesti do prolaznog i reverzibilnog blagog povišenja razina glukoze u plazmi.
English: Therefore, Velactis-treated cows should not be allowed to have access to open water, and should not contaminate watercourses with faeces until at least 5 days after administration.
Croatian: Zato krave tretirane Velactisom ne smiju imati pristup otvorenoj vodi te se vodeni tokovi ne smiju kontaminirati njihovim fecesom najmanje 5 dana nakon primjene.