natgillin/translations-raw huggingface dataset:
The dispersible tablet is contained in a child-proof blister.
Tableta za oralnu suspenziju nalazi se u blisteru sigurnom za djecu.
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.
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
The NOAEL was 21 times (at Day 21 post partum) and 2.3 times (Day 69 post partum) the human therapeutic exposure, respectively.
No observed adverse effect level) je bila 21 put (na 21. postpartalni dan) odnosno 2,3 puta (na 69.
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.
bolesnika dobivalo je bosentan u dnevnim dozama od 100 mg do 2000 mg, a 1838 bolesnika dobivalo je placebo.
Cartons contain 56 film-coated tablets (Tracleer 62.5 mg film-coated tablets).
Kutije sadrže 56 filmom obloženih tableta (Tracleer 62,5 mg filmom obložene tablete).
Mar ______
Ožujak ______
Cartons contain 56 film-coated tablets (Tracleer 125 mg film-coated tablets).
Kutije sadrže 56 filmom obloženih tableta (Tracleer 125 mg filmom obložene tablete).
Tracleer 125 mg film-coated tablets Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side.
Tracleer 125 mg filmom obložene tablete Narančasto-bijele, ovalne, bikonveksne filmom obložene tablete, s oznakom „125“ na jednoj strani.
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.
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.
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).
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).
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.
Dodatni lijekovi za sistemsku sklerozu i ulceracije prstiju bili su dozvoljeni ako su uzimani najmanje 1
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.
Ipak, Tracleer može uzrokovati hipotenziju (pad krvnog tlaka) što može uzrokovati osjećaj omaglice,
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).
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).
112 film-coated tablets (Tracleer 62.5 mg film-coated tablets).
filmom obloženih tableta (Tracleer 62,5 mg filmom obložene tablete).
Cartons contain 56 dispersible tablets.
Kutije sadrže 56 tableta za oralnu suspenziju.
Tracleer 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
Tracleer 62,5 mg filmom obložene tablete su narančasto-bijele, okrugle filmom obložene tablete s oznakom „62,5“ na jednoj strani.
Tracleer 62.5 mg film-coated tablets bosentan
Tracleer 62,5 mg filmom obložene tablete bosentan
• 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).
• 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).
Of the 7 patients who deteriorated at week 8, 3 improved at week 12/16 and 4 deteriorated compared with baseline.
3 došlo je do poboljšanja nakon 12/16 tjedana, a u 4 je došlo do pogoršanja.
Tracleer 62.5 mg film-coated tablets Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side.
Tracleer 62,5 mg filmom obložene tablete Narančasto-bijele, okrugle, bikonveksne filmom obložene tablete, s oznakom „62,5“ na jednoj strani.
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).
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:
Do not store above 25 °C
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25°C
Tracleer 125 mg film-coated tablets bosentan
Tracleer 125 mg filmom obložene tablete bosentan
Tracleer 32 mg dispersible tablets
Tracleer 32 mg tablete za oralnu suspenziju
Tracleer 32 mg dispersible tablets bosentan
Tracleer 32 mg tablete za oralnu suspenziju bosentan
Jul ______
Listopad _____
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.
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
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.
[sildenafil] u monoterapiji [35,9%], bosentanom u monoterapiji [10,9%] i kombinacijom bosentana,
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.
dijafragma ili kontracepcijska spužva uz bilo koju od navedenih vrsta hormonalne kontracepcije.
> 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).
> 3 i ≤ 5 × GGN Nalaz treba potvrditi drugim testom jetrene funkcije; ako je potvrđen, donijeti odluku za svakog bolesnika ponaosob da li nastaviti liječenje
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Plućna arterijska hipertenzija Liječenje smije započeti i nadzirati jedino liječnik s iskustvom u liječenju PAH-a.
Tracleer 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side.
Tracleer 125 mg filmom obložene tablete su narančasto bijele, okrugle filmom obložene tablete s oznakom „125“ na jednoj strani.
Each dispersible tablet contains 32 mg bosentan (as monohydrate)
Jedna tableta za oralnu suspenziju sadrži 32 mg bosentana (u obliku bosentan hidrata)
Liver test abnormalities
Abnormalne vrijednosti testova jetrene funkcije
Each dispersible tablet contains 32 mg bosentan (as monohydrate).
Jedna tableta za oralnu suspenziju sadrži 32 mg bosentana (u obliku bosentan hidrata).
Feb ______
Svibanj ______
How to store Tracleer
Moguće nuspojave Kako čuvati Tracleer
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.
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.
Aug ______
Travanj ______
Each tablet contains 125 mg of bosentan (as monohydrate).
Jedna tableta za oralnu suspenziju sadrži 125 mg bosentana (u obliku bosentan hidrata).
• Hypersensitivity reactions (including skin inflammation, itching and rash)
• Reakcije preosjetljivosti (uključujući upalu, svrbež i osip na koži) • Gastroezofagealna refluksna bolest (vraćanje kiselog sadržaja iz želuca)
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).
Sigurnost i podnošljivost bosentana ispitana je u eksploratornij, nekontroliranoj 12-tjednoj studiji na
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).
32 (studija AC-052-351) i 213 (studija AC-052-352 [BREATHE-1]) odrasla bolesnika s PAH-om
A careful benefit/risk assessment should be made, taking into consideration the liver toxicity of bosentan (see sections 4.4 and 4.8).
Treba napraviti pažljivu procjenu koristi i rizika, uzimajući u obzir da je bosentan toksičan za jetru
Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Silica colloidal anhydrous Tartaric acid
Drugi sastojci su mikrokristalična celuloza, kalcijev hidrogenfosfat, bezvodni, karmelozanatrij,
Liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals for the duration of treatment with Tracleer.
Prije početka liječenja i svaki mjesec tijekom liječenja Tracleerom treba izmjeriti vrijednosti jetrenih aminotransferaza.
Jun ______
Rujan _____
Jan ______
Studeni _____
• Gastrooesophageal reflux disease (acid reflux)
• Ciroza (stvaranje ožiljaka) jetre, zatajenje jetre (teški poremećaj funkcije jetre)
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).
g/dl od početne vrijednosti prijavljeno je kod 8,0% bolesnika koji su dobivali bosentan i 3,9%
164 ng·h/mL, n = 11).
U stanju dinamičke ravnoteže AUCτ je bila 6165 ng•h/mL (CV: 133%, n =
Тел.
Vas.
Re-introduction of treatment
Učinci liječenja
Slovak Republic Actavis Group PTC ehf Reykjavikurvegi 76-78
Češka Republika Actavis Group PTC ehf Reykjavikurvegi 76-78
EU/2/19/239/001 Baycox Iron
EU/2/19/239/001 Baycox Iron 36 mg/ml / 182 mg/mL
Piglets
Karencija
Meat and offal: 53 days
53 dana.
Intramuscular use
Intramuskularna injekcija
Each ml contains:
Svaki ml sadržava:
Date of first authorisation: 09/12/2015
Datum prvog odobrenja: 09/12/2015
More than 74% of cabergoline is bound to plasma protein.
Više od 74% kabergolina je vezano za proteine plazme.
Velactis reduces milk production.
Velactis smanjuje lučenje mlijeka.
Meat and offal: 23 days
Meso i jestive iznutrice: 23 dana
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Pitajte vašeg veterinara ili ljekarnika kako odlagati lijekove koji vam više nisu potrebni.
Prolactin inhibitor
inhibitor prolaktina
Approximately 66% of the administered dose is eliminated by faeces.
Približno 66% primijenjene doze eliminira se fecesom.
This veterinary medicinal product does not require any special storage condition.
Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne uvjete čuvanja.
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:
Djelatna tvar u Velactisu je kabergolin, dozvoljena tvar kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010:
The veterinary medicinal product may cause skin sensitization.
Veterinarsko-medicinski proizvod može izazvati senzibilizaciju kože.
Do not use after the expiry date which is stated on the carton after EXP.
Ne koristiti nakon isteka roka valjanosti naznačenog na kutiji poslije EXP.
This was observed following 1.5-2 times of the recommended dose and was more pronounced at higher doses.
To je uočeno nakon primjene doza 1,5-2 puta većih od preporučene i bilo je izraženije pri većim dozama.
(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.)
(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.)
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.
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.
Urine is the second pathway of elimination.
Sekundarni put eliminacije je urin.
Velactis should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Velactis se ne smije se odlagati u otvorene vode jer to može biti opasno za ribe i druge vodene organizme.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije http://www.ema.europa.eu
Studies in laboratory animals have shown a risk for embryonic death following repeat oral exposure to cabergoline.
Ispitivanja na laboratorijskim životinjama pokazala su da postoji rizik od smrti embrija nakon ponovljene peroralne izloženosti kabergolinu.
Shelf-life after first opening the immediate packaging: 28 days.
Rok trajanja poslije prvog otvaranja unutarnjeg pakovanja: 28 dana.
Cabergoline is rapidly metabolized principally by liver, and is eliminated with a mean half-life of about 20 h.
Kabergolin se brzo metabolizira uglavnom u jetri i eliminira se uz srednju vrijednost poluživota od otprilike 20 sati.
Pharmacotherapeutic group: Other gynaecologicals, prolactin inhibitors, cabergoline ATCvet code: QG02CB03
Farmakoterapijska grupa: Ostali ginekološki pripravci, inhibitori prolaktina, kabergolin ATCvet kod: QG02CB03
If you notice any serious effects or any other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP, molimo obavijestite svog veterinara.
Fatal meteorism has been observed in a single cow following a second administration of 5 times the recommended dose.
Fatalni meteorizam je uočen kod jedne krave nakon druge primjene doze 5 puta veće od preporučene.
Normal aseptic procedures for administration of an intramuscular injection should be followed.
Treba slijediti uobičajene aseptične postupke za primjenu intramuskularne injekcije.
This could theoretically decrease the metabolisation of cabergoline, and prolong its persistence in plasma from cows treated concomitantly with Velactis and such products.
To bi teoretski moglo usporiti metabolizam kabergolina te produljiti njegovo zadržavanje u plazmi kod krava koje su istovremeno liječene Velactisom i takvim proizvodima.
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.
U nedostatku podataka o ishodu trudnoće u ljudi nakon injiciranja kabergolina, trudnice i žene koje pokušavaju začeti trebaju izbjegavati doticaj s proizvodom.
Overdose (symptoms, emergency procedures, antidotes), if necessary Overdoses resulted in some cases in slight and transient decrease of appetite.
Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Predoziranje je u nekim slučajevima uzrokovalo blago i prolazno smanjenje apetita.
MARKETING AUTHORISATION NUMBER(S) EU/2/15/192/001-004
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/15/192/001-004
Only use a dry sterile needle and avoid the introduction of humidity/water during use.
Koristite samo suhu sterilnu iglu kako biste izbjegli unos vlage/vode tijekom primjene.
TARGET SPECIES Cattle (dairy cows)
CILJNE VRSTE ŽIVOTINJA Goveda (muzne krave)
Cattle (dairy cows)
Goveda (muzne krave).
Excipients: For the full list of excipients, see section 6.1
Pomoćne tvari: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
Meat and offal: 23 days Milk: - Zero hours after calving when the dry period length is 32 days or more.
Meso i jestive iznutrice: 23 dana Mlijeko: - Nula sati nakon telenja ako je suhostaj trajao 32 dana ili dulje.
Administer the veterinary medicinal product with caution to avoid self-injection.
Veterinarsko-medicinski proizvod primjenjujte oprezno kako biste izbjegli samoinjiciranje.
The product should be injected within 4 hours after the last milking.
Proizvod treba injicirati unutar 4 sata nakon zadnje mužnje.
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use
POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO Pročitati uputu o VMP prije primjene
Three consecutive administrations of 1, 3 or 5 times the recommended dose may result in transient and reversible slight elevation of plasma glucose levels.
Tri uzastopne primjene doze 1, 3 ili 5 puta veće od preporučene može dovesti do prolaznog i reverzibilnog blagog povišenja razina glukoze u plazmi.
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.
Zato krave tretirane Velactisom ne smiju imati pristup otvorenoj vodi te se vodeni tokovi ne smiju kontaminirati njihovim fecesom najmanje 5 dana nakon primjene.
Consequently, cabergoline administration induces a reduction of milk production leading to a reduction in udder engorgement and intramammary pressure.
Posljedično, primjena karbegolina uzrokuje smanjenje proizvodnje mlijeka i dovodi do smanjenja nabreklosti vimena i intramamarnog pritiska.
The administration of three or five times the recommended dose for 3 consecutive days (i.e. corresponding to 9 and 15 times the recommended dose, respectively) resulted in addition in some cases in transient and reversible digestive signs such as diarrhoea.
Primjena doza tri ili pet puta većih od preporučene tijekom 3 uzastopna dana (odgovara 9 odnosno 15 puta većim dozama od preporučene) u nekim je slučajevima dovelo i do prolaznih i reverzibilnih probavnih znakova kao što je proljev.
For use in the herd management programme of dairy cows as an aid in the abrupt drying-off by reducing milk production to: - reduce milk leakage at drying off, - reduce the risk of new intramammary infections during the dry period, - reduce discomfort.
Za primjenu u planiranom upravljanju stadom muznih krava kao pomoć pri naglom zasušivanju smanjivanjem lučenja mlijeka kako bi se: - smanjilo curenje mlijeka tijekom isušivanja, - smanjio rizik novih intramamarnih infekcija tijekom suhostaja, - smanjila nelagoda.
For the 25 ml, 50 ml and the 5x5ml only: Once broached, use within 28 days.
Samo za pakovanja od 25 ml, 50 ml i 5x5ml: Nakon otvaranja, upotrijebite unutar 28 dana.
Cabergoline is a synthetic ergot derivative, which is a potent dopamine receptor agonist on D2 receptors.
Kabergolin je sintetski derivat ergolina koji je snažan agonist D2 dopaminskih receptora.
Overdoses resulted in some cases in slight and transient decrease of appetite.
Predoziranje je u nekim slučajevima uzrokovalo blago i prolazno smanjenje apetita.
Brown glass vials closed by bromobutyl stoppers and crimped with aluminium and plastic flip capsules.
Bočice od smeđeg stakla zatvorene bromobutilnim čepovima obavijenim s aluminijskom kapicomi s plastičnim "flip-off" zatvaračima.
Clear pale yellow solution.
Bistra blijedo žuta otopina.
- 4 days (8 milkings) after calving when the dry period length is less than 32 days
- 4 dana (8 mužnji) nakon telenja ako je suhostaj trajao kraće od 32 dana.
Subsequently udder pain and discomfort are reduced at one and two days after drying off, respectively.
Posljedično se bol i nelagoda u vimenu smanjuju tijekom jednog odnosno dva dana nakon zasušivanja.
After intramuscular administration in cattle, the systemic absorption of cabergoline is rapid and important (bioavailability over 90%), with a peak concentration observed around 3 h after administration and followed by a high tissue distribution.
Nakon intramuskularne primjene u goveda, sistemska apsorpcija kabergolina je brza i značajna (biodostupnost preko 90%), s vršnom koncentracijom uočenom otprilike 3 sata nakon primjene popraćenom visokim stupnjem tkivne distribucije.
The cows should be diagnosed to be free of subclinical mastitis by using suitable criteria such as bacterial examination of milk, somatic cell count or other recognized tests.
Odsutnost subkliničkog mastitisa u krava treba potvrditi prema odgovarajućim kriterijima kao što su bakteriološki pregled mlijeka, broj somatskih stanica ili drugi priznati testovi.
The veterinary medicinal product may cause skin sensitisation and persons with a known hypersensitivity to cabergoline or any of the excipients should avoid contact with it.
Veterinarsko-medicnski proizvod može uzrokovati senzibilizaciju kože i osobe preosjetljive na kabergolin ili bilo koju od pomoćnih tvari trebaju izbjegavati kontakt s njim.
In vitro, some macrolide antibiotics, like erythromycin, inhibited the activity of bovine Cytochrom P 450-enzymes (CYP3A4-subclass).
In vitro su neki makrolidni antibiotici, kao eritromicin, inhibirali aktivnost goveđih enzima citokroma P450 (podvrsta CYP3A4).
Velactis should be used as part of a comprehensive mastitis and milk quality control program under veterinarian advice, which might include the need to use intramammary treatment.
Velactis treba koristiti kao dio sveobuhvatnog programa kontrole mastitisa i kvalitete mlijeka što može uključivati i potrebu intramamarne terapije pod nadzorom veterinara.
The product should be administered within 4 hours after the last milking.
Proizvod treba primijeniti unutar 4 sata nakon zadnje mužnje.
QUANTITY OF THE ACTIVE SUBSTANCE(S) 1.12 mg/ml
KOLIČINA DJELATNE(IH) TVARI 1,12 mg/ml
Pregnant or breastfeeding women and women attempting to conceive should avoid contact with the solution and should be prevented from an accidental self-injection.
Trudnice ili žene koje doje te žene koje pokušavaju začeti trebaju izbjegavati kontakt s otopinom i spriječiti slučajno samoinjiciranje.
Cardboard box with 1 vial of 5 ml, 25 ml or 50 ml, or 5 vials of 5 ml.
Kartonska kutija s jednom bočicom od 5 ml, 25 ml ili 50 ml; ili 5 bočica od 5 ml.
Milk: - zero hours after calving when the dry period length is 32 days or more.
Mlijeko: - nula sati nakon telenja ako je suhostaj trajao 32 dana ili dulje.
Cabergoline should not enter surface waters as it has harmful effects on aquatic species.
Kabergolin ne smije dospjeti u površinske vode jer štetno djeluje na vodene organizme.