natgillin/translations-raw huggingface dataset:
However, 1,611 patients (804 bosentan- and 807 placebo-treated patients) with severe chronic heart failure (CHF) were treated for a mean duration of 1.5 years in a placebocontrolled study (study AC-052-301/302 [ENABLE 1 & 2]).
2]) s povprečnim trajanjem zdravljenja 1,5 let sodelovalo 1.611 bolnikov (804 bolniki so jemali bosentan, 807 bolnikov je prejemalo placebo) s hudim kroničnim srčnim popuščanjem (CHF
For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with Tracleer is not recommended.
itrakonazolom ali ritonavirjem) in tudi zaviralcem CYP2C9 (denimo, vorikonazolom).
112 film-coated tablets (Tracleer 62.5 mg film-coated tablets).
14, 56 ali 112 filmsko obloženih tablet (Tracleer 62,5 mg filmsko obložene tablete).
Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Silica colloidal anhydrous Tartaric acid
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi mikrokristalna celuloza brezvodni kalcijev hidrogenfosfat natrijev karmelozat, premreženi koloidni brezvodni silicijev dioksid vinska kislina aroma sadja aspartam (E951) kalijev acesulfamat magnezijev stearat
Each film-coated tablet contains 62.5 mg bosentan (as monohydrate)
Ena filmsko obložena tableta vsebuje 62,5 mg bosentana v obliki bosentana monohidrata.
A.
‘II.
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Pljučna arterijska hipertenzija Zdravljenje naj začne in vodi zdravnik z izkušnjami z zdravljenjem PAH.
24 weeks of study treatment without experiencing PAH worsening.
Po Kaplan-Meierjevem izračunu je bilo po 24 tednih brez dogodkov poslabšanja PAH (smrt,
Aug ______
Avg ______
• a pregnancy test if you are a woman of childbearing potential Some patients taking Tracleer have been found to have abnormal liver function tests and anaemia (low haemoglobin).
Pri nekaterih bolnikih, ki so uporabljali zdravilo Tracleer, so ugotovili nenormalne vrednosti testov delovanja jeter in anemijo (nizek hemoglobin).
- Keep this leaflet.
Odluščite vrhnje plasti.
Package leaflet: Information for the user Tracleer 62.5 mg film-coated tablets
Filmsko obložena tableta (filmsko obložene tablete): Tracleer 62,5 mg filmsko obložene tablete
P-value
95-% MZ Vrednost p
United Kingdom Actavis Group PTC ehf Reykjavikurvegi 76-78
Velika Britanija Actavis Group PTC ehf Reykjavikurvegi 76-78
Meat and offal: 53 days
Meso in organi: 53 dni.
Strength Pharmaceutical form
Farmacev tska oblika
Piglets
Prašiči
Content Package size
Način uporabe Pakiranje Vsebina Velikost pakiranja Karenca
Intramuscular use
Intramuskularna injekcija viala (steklo)
EU/1/11/741/001 Levetiracetam SUN 100 mg/ml
EU/1/11/741/001 Levetiracetam SUN 100 mg/ml koncentrat za raztopino za infundiranje
Intravenous use vial (glass) 5 ml
Intravenska uporaba steklenih vialah
More than 74% of cabergoline is bound to plasma protein.
Več kot 74% kabergolina se veže na plazemske proteine.
Date of first authorisation: 09/12/2015
Datum pridobitve dovoljenja za promet: 09/12/2015
Velactis reduces milk production.
Zdravilo Velactis zmanjšuje proizvodnjo mleka.
Meat and offal: 23 days
Meso in organi: 23 dni
This was observed following 1.5-2 times of the recommended dose and was more pronounced at higher doses.
To je bilo opaženo po dajanju 1,5-2 kratnega priporočenega odmerka in je bilo bolj izraženo pri visokih odmerkih.
Studies in laboratory animals have shown a risk for embryonic death following repeat oral exposure to cabergoline.
Raziskave na laboratorijskih živalih so pokazale, da obstaja tveganje za embrionalno smrtnost po ponavljajoči se oralni izpostavljenosti kabergolinu.
(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.)
(Ni podatkov o izzidu nosečnosti pri ljudeh po injekciji kabergolina, a raziskave na laboratorijskih živalih so pokazale nevarnost embrionalne smrtnosti po ponavljajoči se oralni izpostavljenosti kabergolinu.)
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali med enim zdravljenjem) - pogosti (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 100 živali) - občasni (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 1.000 živali) - redki (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
Prolactin inhibitor
Inhibitor prolaktina
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Pred uporabo preberite navodilo za uporabo.
Velactis should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Zdravilo Velactis ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.
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.
Za pomožne snovi, navedene v poglavju 6.1 SPC , tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
If you notice any serious effects or any other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
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 zdravljene z zdravilomVelactis ne smejo imeti dostopa do odprtih voda in ne smejo kontaminirati vodnih virov z blatom vsaj 5 dni po dajanju zdravila.
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:
Zdravilna učinkovina v Velactisu jekabergolin, dovoljena učinkovina, kot je navedena v tabeli 1(dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010,:
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.)
Subsequently udder pain and discomfort are reduced at one and two days after drying off, respectively.
Tako se zmanjšata bolečina vimena in nelagodje en ali dva dni po presušitvi.
Liver Kidney Muscle Milk
Maščoba Jetra Ledvice Mišice Mleko
Cabergoline is rapidly metabolized principally by liver, and is eliminated with a mean half-life of about 20 h.
Kabergolin se hitro metabolizira predvsem v jetrih in izloča s srednjo razpolovno dobo okrog 20 ur.
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 uporabo v programu upravljanja čred krav molznic kot pomoč pri nenadnem presuševanju z zmanjšanjem proizvodnje mleka za: - zmanjšanje uhajanja mleka ob presuševanju - zmanjšanje tveganja novih intramamarnih okužb med obdobjem presušitve - zmanjšanje nelagodja.
Approximately 66% of the administered dose is eliminated by faeces.
Približno 66% odmerka se izloči z blatom.
Pharmacotherapeutic group: Other gynaecologicals, prolactin inhibitors, cabergoline ATCvet code: QG02CB03
Farmakoterapevtska skupina: druge ginekološke substance, prolaktin inhibitor, kabergolin oznaka ATC vet: QG02CB03
For cows considered likely to be free of subclinical mastitis at drying off, in which antibiotic use is not justified/permitted, Velactis can be used as a dry cow treatment.
Za krave, ki so v presušitvenem obdobju smatrane kot proste subkliničnega mastitisa, kjer uporaba antibiotikov ni upravičena/dovoljena, se zdravilo Velactis lahko uporablja za presušitev.
Excipients: For the full list of excipients, see section 6.1
Pomožna(pomožne) snov(i): Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Consequently, cabergoline administration induces a reduction of milk production leading to a reduction in udder engorgement and intramammary pressure.
Posledično dajanje kabergolina povzroči zmanjšano proizvodnjo mleka kar vodi k zmanjšanju nabrekanja vimena in intramamarnega pritiska.
MARKETING AUTHORISATION NUMBER(S) EU/2/15/192/001-004
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/15/192/001-004
Active substance: Cabergoline ....................................................................... 1.12 mg
Zdravilna(e) učinkovina(e): Kabergolin ……………………………………………….1,12 mg
TARGET SPECIES Cattle (dairy cows)
CILJNE ŽIVALSKE VRSTE Govedo (krave molznice)
This could theoretically decrease the metabolisation of cabergoline, and prolong its persistence in plasma from cows treated concomitantly with Velactis and such products.
To lahko teoretično zmanjša metabolizem kabergolina in podaljša njegov obstoj v plazmi pri kravah zdravljenih sočasno z zdravilom Velactis in navedenimi antibiotiki.
Cabergoline is a synthetic ergot derivative, which is a potent dopamine receptor agonist on D2 receptors.
Kabergolin je sintetični ergot derivat, ki je močan agonist dopaminskih D2 receptorjev.
- 4 days (8 milkings) after calving when the dry period length is less than 32 days
- 4 dni (8 molž) po telitvi, ko je obdobje presušitve manj kot 32 dni.
Overdose (symptoms, emergency procedures, antidotes), if necessary Overdoses resulted in some cases in slight and transient decrease of appetite.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Preveliko odmerjanje je v nekaterih primerih povzročilo blago in prehodno zmanjšanje apetita.
Three consecutive administrations of 1, 3 or 5 times the recommended dose may result in transient and reversible slight elevation of plasma glucose levels.
Trikratno zaporedno dajanje 1, 3 ali 5 kratnega priporočenega odmerka lahko povzroči prehodno in reverzibilno blago povišanje nivoja glukoze v plazmi.
Overdoses resulted in some cases in slight and transient decrease of appetite.
Preveliko odmerjanje je v nekaterih primerih povzročilo blago in prehodno zmanjšanje apetita.
The efficacy of Velactis in reducing the risk of new intramammary infections during the dry period when administered concomitantly with antimicrobial treatment to cows with intramammary infections has not been investigated compared to antimicrobial treatment alone.
Učinkovitost Velactisa pri zmanjšanju tveganja novih intramamarnih okužb v obdobju presušitve ob sočasnem protimikrobnem zdravljenju krav z intramamarno okužbo, ni bila raziskana v primerjavi samo s protimikrobnim zdravljenjem.
Fatal meteorism has been observed in a single cow following a second administration of 5 times the recommended dose.
Smrtni meteorizem je bil opažen pri eni kravi po drugem dajanju 5 kratnega priporočenega odmerka.
Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale
Imetnik dovoljenja za promet z zdravilom in izdelovalec odgovoren za sproščanje serij: Ceva Santé Animale
At 9 times the recommended dose a decrease in ruminal activity may be observed.
Pri 9 kratnem priporočenem odmerku lahko opazimo zmanjšanje aktivnosti vampa.
Brown glass vials closed by bromobutyl stoppers and crimped with aluminium and plastic flip capsules.
Rjava viala (iz stekla) z brombutilnim zamaškom in aluminijasto in plastično flip zaporko.
Shelf-life after first opening the immediate packaging: 28 days.
Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
Due to its pharmacological effect (inhibition of lactation) breastfeeding women should avoid contact with the product.
Zaradi farmakološkega učinka (inhibicija laktacije) naj se doječe ženske izogibaju stiku z zdravilom.
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 je potrebno uporabljati kot del celovitega programa za nadzor mastitisa in kakovosti mleka v skladu z navodili veterinarja, ki lahko vključujejo tudi uporabo intramamarnega zdravljenja.
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.
Dajanje tri ali petkratnega priporočenega odmerka 3 zaporedne dni (kar ustreza 9 in 15 kratnemu priporočenemu odmerku) je v nekaterih primerih povzročilo še dodatne prehodne in reverzibilne prebavne znake kot je driska.
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.
Po intramuskularnem dajanju je pri govedu sistemska absorpcija kabergolina hitra in pomembna (biorazpoložljivost preko 90%), z maksimalno koncentracijo izmerjeno okrog 3 ure po dajanju, sledi visoka distribucija v tkivih.
Cabergoline should not enter surface waters as it has harmful effects on aquatic species.
Kabergolin ne sme vstopiti v površinske vode zaradi škodljivih učinkov na vodne organizme.
Normal aseptic procedures for administration of an intramuscular injection should be followed.
Potrebno je upoštevati normalne aseptične postopke za dajanje intramuskularnih injekcij.
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.
Ker ni podatkov o izzidu nosečnosti pri človeku po injiciranju kabergolina, naj se noseče ženske in ženske, ki se trudijo zanositi, izogibaju stiku z zdravilom.
The difference between groups was 13.7% (95% confidence interval 6.4-21%).
Razlika med skupinama je bila 13.7% (95% interval zaupanja 6.4-21%).
Urine is the second pathway of elimination.
Sekundarna pot izločanja je z urinom.
Clear pale yellow solution.
Bistra bledo rumena raztopina.
Cabergoline Bovine 0.10 µg/kg 0.25 µg/kg
Kabergolin Govedo 0.10 µg/kg 0.25 µg/kg
However, administration of tylosin concomitantly with Velactis in cows did not show any changes of cabergoline pharmacokinetic properties.
Vendar pa dajanje tilozina sočasno z zdravilom Velactis pri kravah ni povzročilo nobenih sprememb v farmakokinetičnih lastnostih kabergolina.
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
NAČIN IN POT(I) UPORABE Intramuskularna uporaba.
Milk: - zero hours after calving when the dry period length is 32 days or more.
Mleko: - Nič ur po telitvi, ko je obdobje presušitve 32 dni ali več.
The difference between groups was 8.7% (95% confidence interval 4.9-12.6%).
Razlika med skupinama je bila 8.7% (95% interval zaupanja 4.9-12.6%).
Pregnant or breastfeeding women and women attempting to conceive should avoid contact with the solution and should be prevented from an accidental self-injection.
Noseče ženske in ženske, ki se trudijo zanositi naj se izogibajo stiku z raztopino in naj ne pride do nenamernega samo-injiciranja.
For the 25 ml, 50 ml and the 5x5ml only: Once broached, use within 28 days.
Samo za 25 ml, 50 ml in 5 x 5 ml: Načeto zdravilo uporabite v 28 dneh.
ADVICE ON CORRECT ADMINISTRATION Normal aseptic procedures for administration of an intramuscular injection should be followed.
NASVET O PRAVILNI UPORABI ZDRAVILA Potrebno je upoštevati normalne aseptične postopke za dajanje intramuskularnih injekcij.
QUANTITY OF THE ACTIVE SUBSTANCE(S) 1.12 mg/ml
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) 1.12 mg/ml
Slight injection site reactions (mostly swellings) were commonly observed after injection of the product and may persist for at least 7 days.
Po injiciranju zdravila je bila pogosto opažena blaga reakcija na mestu injiciranja (predvsem otekanje), ki lahko traja vsaj 7 dni.
It acts on dopamine receptors of prolactin producing cells in the pituitary gland suppressing the prolactin production and leading to the inhibition of prolactin secretion dependent process.
Deluje na dopaminske receptorje celic, ki proizvajajo prolaktin v hipofizi, zavira proizvodnjo prolaktina in vodi v inhibicijo procesov, ki so odvisni od izločanja prolaktina.
In a multicentric randomized clinical trial where dairy cows with no intramammary infections at the time of drying-off were administered either Velactis or placebo at the time of drying-off, the incidence of new intramammary infections within 7 days after subsequent calving was significantly lower among udder quarters of cows treated with Velactis (20.5%) as compared to placebo (26.0%).
V multicentrični naključni klinični raziskavi, kjer so kravam brez intramamarnih okužb v času presušitve dajali ali zdravilo Velactis ali placebo, je bil pojav novih intramamarnih okužb v 7 dneh po naknadni telitvi bistveno nižji v vimenskih četrtih krav zdravljenih z zdravilom Velactis (20.5%) v primerjavi s placebom (26.0%).
The recommended dose is 5.6 mg of cabergoline (corresponding to 5 ml of solution for injection) per animal in one single injection at the day of drying-off after the last milking.
Priporočen odmerek je 5,6 mg kabergolina (kar ustreza 5 ml raztopine za injiciranje) na žival v enem odmerku na dan presušitve po zadnji molži.
In the same study, incidence of milk leakage was significantly lower among Velactis treated animals (2.0%) as compared to placebo treated animals (10.7%).
V isti raziskavi je bil pojav uhajanja mleka bistveno nižji pri živalih zdravljenih z zdravilom Velactis (2.0%) v primerjavi s placebom (10.7%).
Dimethyl sulfoxide Triglycerides, medium-chain
Seznam pomožnih snovi dimetilsulfoksid trigliceridi, nasičeni, srednjeverižni
The product should be injected within 4 hours after the last milking.
Zdravilo dajte znotraj 4 ur po zadnji molži.
In vitro, some macrolide antibiotics, like erythromycin, inhibited the activity of bovine Cytochrom P 450-enzymes (CYP3A4-subclass).
In vitro lahko nekateri makrolidni antibiotiki, kot je eritromicin, zavirajo delovanje govejega Citohroma P 450-encima (CYP3A4-podrazred).
Special precautions for use in animals The product should only be used in dairy cows at the time of drying-off.
Posebni previdnostni ukrepi za uporabo pri živalih Zdravilo uporabite le pri kravah molznicah v obdobju presušitve.
Interactions with other medicinal products and other forms of interaction In vitro, some macrolide antibiotics like erythromycin inhibited the activity of bovine Cytochrom P 450-enzymes (CYP3A4-subclass).
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij In vitro lahko nekateri makrolidni antibiotiki, kot je eritromicin, zavirajo delovanje govejega Citohroma P 450-encima (CYP3A4-podrazred).
In a randomized and placebo controlled clinical study, reduced discomfort was demonstrated during the first day after drying-off by increasing daily lying time by 143 +/- 17 minutes in Velactis treated animals in comparison with untreated controls.
V naključni in s placebom kontrolirani klinični raziskavi je bilo prvi dan po presušitvi ugotovljeno zmanjšano nelagodje z daljšim časom ležanja za 143+/- 17 minut pri živalih, ki so bile zdravljene z zdravilom Velactisom v primerjavi z nezdravljeno kontrolno skupino.
Administer the veterinary medicinal product with caution to avoid self-injection.
Zdravilo dajajte previdno, da se izognete samo-injiciranju.
Persons with a known hypersensitivity to cabergoline or any of the excipients should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo na kabergolin ali katerokoli drugo pomožno snov naj se izogibajo stiku z zdravilom.
The recommended dose is 5.6 mg of cabergoline (corresponding to 5 ml of Velactis) per animal in one single injection at the day of drying-off after the last milking.
Priporočen odmerek je 5,6 mg kabergolina (kar ustreza 5 ml Velactisa) na žival v enem odmerku na dan presušitve po zadnji molži.
Do not use in case of hypersensitivity to cabergoline or to any of the excipients.
Ne uporabite v primeru preobčutljivosti na kabergolin ali na katero koli pomožno snov.
This was confirmed in another multicentric randomized clinical trial where incidence of milk leakage was significantly lower among Velactis treated animals (3.9%) as compared to placebo treated animals (17.6%).
To je bilo potrjeno v drugi multicentrični naključni klinični raziskavi, kjer je bil pojav uhajanja mleka pri živalih zdravljenih z zdravilom Velactis bistveno nižji (3.9%) v primerjavi s placebom (17.6%).
In case of accidental self-injection, seek medical advice, and show the package leaflet or the label to the physician.
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Cardboard box of 5 ml vial Cardboard box of 25 ml vial Cardboard box of 50 ml vial Cardboard box of 5x5 ml vials
Kartonska škatla s 5 ml vialo Kartonska škatla s 25 ml vialo Kartonska škatla s 50 ml vialo Kartonska škatla s 5x5 ml vialami
The difference in percentage of new intramammary infections during the dry period between Velactis treated animals and the placebo group was 5.5% (95% confidence interval 0.5-10.4%).
Razlika v odstotku novih intramamarnih okužb v obdobju presušitve med živalmi zdravljenimi z zdravilom Velactis in s placebom je bila 5.5% (95% intreval zaupanja 0.510.4%).
CONTRAINDICATIONS Do not use in case of hypersensitivity to cabergoline or to any of the excipients.
KONTRAINDIKACIJE Ne uporabite v primeru preobčutljivosti na kabergolin ali na katero koli pomožno snov.
The veterinary medicinal product may cause skin sensitization.
Zdravilo lahko draži kožo.
The difference in occurrence of pain was 9.9% (95% confidence interval 4.0-15.8%) between the Velactis treated cows compared to placebo treated animals.
Razlika v pojavu bolečine je bila 9.9% (95% intreval zaupanja 4.0-15.8%) med kravami zdravljenimi z zdravilom Velactis in kravami, ki so prejele placebo.
In a randomized and placebo controlled clinical study Velactis treated cows presented less signs of udder pain in comparison with controls on the first two days after drying-off.
V naključni in s placebom kontrolirani klinični raziskavi so v prvih dveh dneh krave, ki so bile zdravljene z zdravilom Velactis pokazale manj znakov bolečin vimena v primerjavi s kontrolno skupino.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains 1.12 mg of cabergoline.
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN Vsak ml vsebuje 1,12 mg kabergolina.
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.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Zdravilo lahko draži kožo in osebe z znano preobčutljivostjo na kabergolin ali katerokoli drugo pomožno snov naj se izogibajo stiku z zdravilom.
Cardboard box with 1 vial of 5 ml, 25 ml or 50 ml, or 5 vials of 5 ml.
Kartonska škatla z 1 vialo s 5 ml, 25 ml ali 50 ml ali 5 vialami s 5 ml. Ni nujno, da so v prometu vsa navedena pakiranja.