natgillin/translations-raw huggingface dataset:
Interrupt Iclusig for serious or severe haemorrhage and evaluate.
Pri resni ali hudi krvavitvi je treba zdravljenje z zdravilom Iclusig prekiniti in bolnika oceniti.
T315I Cohort (N=64)
T315I kohorta (N = 64)
• hot flush, flushing
• vročinski oblivi, zardevanje
There is insufficient data available to make formal recommendations on dose reduction (in the absence of an adverse event) in patients with chronic phase (CP) CML patients who have achieved Major Cytogenetic Response.
Pri bolnikih s kronično fazo s KML v kronični fazi (KF), ki so dosegli bistven citogenetski odgovor, ni dovolj podatkov za formalna priporočila o zmanjšanju odmerka (v odsotnosti neželenega učinka).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg of ponatinib (as hydrochloride).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 15 mg ponatiniba (v obliki klorida).
Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased
Presnovne in prehranske motnje zelo pogosti zmanjšan apetit pogosti dehidracija, zastajanje tekočine, hipokalciemija, hiperglikemija, hiperurikemija, hipofosfatemija, hipertrigliceridemija, hipokaliemija, zmanjšanje telesne mase občasni sindrom tumorske lize
T315I Cohort (N=18)
T315I kohorta (N = 18)
Reproductive system and breast disorders
Motnje reprodukcije in dojk pogosti erektilna disfunkcija
• a history of blood clots in your blood vessels
• krvne strdke v žilah v zdravstveni zgodovini
(95% CI) a Primary endpoint for CP-CML Cohorts was MCyR, which combines both complete (No detectable Ph+
(95-% IZ) a Primarni opazovani dogodek za kohorte CP-KML je bil MCyR, kar združuje celovit (brez zaznavnih celic Ph+) in delni (1 % do 35 % celic Ph+) citogenetski odgovor.
T315I Cohort (N=22)
T315I kohorta (N = 22)
Common blood bilirubin increased, blood alkaline phosphatase increased, gammaglutamyltransferase increased
Bolezni jeter, žolčnika in žolčevodov zelo pogosti zvišanje ravni alanin aminotransferaze, zvišanje ravni aspartat-aminotransferaze pogosti zvišanje ravni bilirubina v krvi, zvišanje ravni alkalne fosfataze v krvi, zvišanje ravni gama-glutamiltransferaze občasni hepatotoksičnost, zlatenica
• Withhold Iclusig and resume at 15 mg after recovery to
• Z uporabo zdravila Iclusig prenehajte in po okrevanju na
T315I Cohort (N=24)
T315I kohorta (N = 24)
Close clinical surveillance is recommended when ponatinib is administered with these medicinal products.
Pri dajanju ponatiniba s temi zdravili se priporoča skrbno klinično spremljanje.
Serious bleeding events and haemorrhage, including fatalities, occurred in Iclusig-treated patients.
Pri bolnikih, zdravljenih z zdravilom Iclusig, so se pojavile resne krvavitve in hemoragije, vključno s smrtnimi.
Haemorrhage
Mielosupresija
OUTER CARTON AND BOTTLE LABEL
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ZUNANJA ŠKATLA IN NALEPKA NA PLASTENKI
Resistant or Intolerant a Primary endpoint for AP-CML and BP-CML/Ph+ ALL Cohorts was MaHR, which combines complete haematological responses and no evidence of leukaemia.
(95-% IZ) a Primarni opazovani dogodek za kohorti AP-KML in BP-KML/Ph+ ALL je bil MaHR, ki združuje celovit hematološki odgovor in odsotnost dokazov o levkemiji.
Very common bone pain, arthralgia, myalgia, pain in extremity, back pain, muscle spasms
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti bolečine v kosteh, artralgija, mialgija, bolečine v okončinah, bolečine v hrbtu, mišični krči pogosti mišično-skeletne bolečine, bolečine v vratu, mišično-skeletne bolečine v prsnem košu
Sodium decreased
Znižana raven natrija
Common pancreatitis, blood amylase increased, gastrooesophageal reflux disease, stomatitis, dyspepsia, abdominal distension, abdominal discomfort, dry mouth
Bolezni prebavil zelo pogosti bolečine v trebuhu, driska, bruhanje, zaprtje, navzea, zvišanje ravni lipaz pogosti pankreatitis, zvišanje amilaz v krvi, gastroezofagealna refluksna bolezen, stomatitis, dispepsija, trebušna distenzija, nelagodje v trebuhu, suha usta občasni krvavitev v želodcu
A single dose of 30 mg ponatinib was administered to patients with mild, moderate, or severe hepatic impairment and to healthy volunteers with normal hepatic function.
Bolnikom z blago, zmerno ali hudo okvaro jeter in zdravim prostovoljcem z normalnim delovanjem jeter so dali enkratni odmerek 30 mg ponatiniba.
Common side effects (affects 1 to 10 users in 100):
Pogosti neželeni učinki (pojavijo se pri 1 do 10 od 100 bolnikov):
Uncommon retinal vein thrombosis, retinal vein occlusion, retinal artery occlusion, visual impairment
Očesne bolezni pogosti zamegljen vid, suhe oči, periorbitalni edem, edem veke občasni tromboza mrežnične vene, okluzija mrežnične vene, okluzija mrežnične arterije, okvara vida
NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets Ponatinib
Iclusig 15 mg filmsko obložene tablete ponatinib
Cytogenetic Response Major (MCyR) a
Citogenetski odgovor Bistven (MCyR) a (95-% IZ) Celovit (CCyR) (95-% IZ) Bistven molekularni odgovor b %
ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit juice.
Pri sočasni uporabi močnih zaviralcev CYP3A, kot so klaritromicin, indinavir, itrakonazol, ketokonazol, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromicin, troleandomicin, vorikonazol in sok grenivke, je potrebna previdnost, razmisliti pa je treba tudi o zmanjšanju začetnega odmerka zdravila Iclusig na 30 mg,
ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Third occurrence:
• Z uporabo zdravila Iclusig prenehajte in po okrevanju na ANC ≥ 1,5 x 109/l in trombociti ≥ 75 x 109/l začnite z odmerkom 30 mg Tretji pojav:
Iclusig contains lactose
- vnetje trebušne slinavke
Colloidal anhydrous silica
Zvišana raven alkalne fosfataze
ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Second occurrence:
• Z uporabo zdravila Iclusig prenehajte in po okrevanju na ANC ≥ 1,5 x 109/l in trombociti ≥ 75 x 109/l začnite z odmerkom 45 mg Drugi pojav:
Ponatinib did not exhibit genotoxic properties when evaluated in the standard in vitro and in vivo systems.
Ponatinib v ocenah s standardnimi sistemi in vitro in in vivo ne kaže genotoksičnih lastnosti.
NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets Ponatinib
Iclusig 45 mg filmsko obložene tablete ponatinib
Potassium decreased
Znižana raven kalija
No Dose Reduction Dose reduction to 30 mg only ≥ 90 day reduction at 30 mg ≥ 180 day reduction at 30 mg ≥ 360 day reduction at 30 mg Any dose reduction to 15 mg ≥ 90 day reduction at 15 mg ≥ 180 day reduction at 15 mg ≥ 360 day reduction at 15 mg
≥ 360-dnevno zmanjšanje pri 15 mg
• insomnia
• nespečnost
Brochure.
stopnje.
- decreased number of white blood cells called neutrophilis (symptoms include: increase tendency of infection)
• spremembe v krvi: - zmanjšano število rdečih krvnih celic (simptomi vključujejo šibkost, omotico, utrujenost) - zmanjšano število trombocitov (simptomi vključujejo povečano nagnjenost h krvavitvam ali nastanku podplutb) - zmanjšano število belih krvnih celic, imenovanih nevtrofilci (simptomi vključujejo povečano nagnjenost k okužbam) - zvišana raven serumske beljakovine, imenovane lipaza
ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L
• Z uporabo zdravila Iclusig prenehajte in po okrevanju na ANC ≥ 1,5 x 109/l in trombociti ≥ 75 x 109/l začnite z odmerkom 15 mg
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 45 mg ponatinib (as hydrochloride).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 45 mg ponatiniba (v obliki klorida).
Consider discontinuing ponatinib if a complete haematologic response has not occurred by 3 months (90 days).
Če v 3 mesecih (90 dneh) ni celovitega hematološkega odgovora, je treba razmisliti o ukinitvi ponatiniba.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg ponatinib (as hydrochloride).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 15 mg ponatiniba (v obliki klorida).
Date of first authorisation: 18/08/2017
Datum prve pridobitve dovoljenja za promet: 18/08/2017
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
1 litre 4 litres
1 liter 4 litri
Light yellow to dark yellow solution.
Rahlo rumena do temno rumena raztopina.
This procedure should be repeated on each day of administration.
Ta postopek je treba ponoviti vsak dan zdravljenja.
Eggs: zero days.
Jajca: 0 dni.
Do not eat, drink or smoke while handling the product.
Pri ravnanju z zdravilom ne jejte, pijte ali kadite.
The complete course of treatment must be administered for a full therapeutic effect.
Za popoln terapevtski učinek je treba izvesti celoten postopek zdravljenja.
This period of time must be long enough to allow all the birds to receive the required dose.
To razdobje mora biti dovolj dolgo, da bodo vse živali lahko dobile potrebni odmerek.
• For each day of treatment, medicated water must be freshly prepared.
• Za vsak dan zdravljenja je treba pripraviti svežo medicirano vodo.
This activity breaks the mite life cycle.
To delovanje prekine življenjski ciklus pršice.
No other source of drinking water should be available during the medication period.
V času zdravljenja ne sme biti na razpolago nobena druga voda za pitje.
Strict biosecurity measures at house and farm level should be implemented to prevent re-infestation of treated houses.
Izvajati je treba stroge ukrepe za biološko varnost v hlevu in na farmi, da preprečimo ponovno infestacijo zdravljenih hlevov.
If another course of treatment is indicated, the interval between two courses of treatment should be at least 3 months.
Če je potreben še en postopek zdravljenja, mora biti razmik med dvema zdravljenjema najmanj 3 mesece.
ATCvet code: QP53BE02.
Oznaka ATC vet: QP53BE02
Always add product and water simultaneously in order to avoid foaming.
Vedno dodajte vodo in zdravilo istočasno, da se izognete penjenju.
After oral administration, fluralaner is absorbed rapidly from the medicated drinking water, reaching maximum plasma concentrations 36 hours after the first dose and 12 hours after the second dose.
Po peroralnem dajanju se fluralaner hitro resorbira iz medicirane vode za pitje in doseže maksimalno koncentracijo v plazmi 36 ur po prvem in 12 ur po drugem odmerku.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini za EXP.
• Make sure the dosing pump is properly set to deliver the medicated water during the predetermined treatment period (hours).
• Prepričajte se, da je odmerna črpalka pravilno nastavljena, da bo dovajala medicirano vodo v preddoločenem razdobju zdravljenja (ure).
• Check the water system to ensure it works properly and is free of leaks; also ensure that water is available to all nipple or bell drinkers.
• Preverite vodni sistem, da zagotovite, da pravilno deluje in ne pušča; zagotovite tudi, da je voda na razpolago na vseh kapalnih in zvončastih napajalnikih.
If the product is spilled, remove any affected clothes.
Če se zdravilo polije, takoj odstranite polita oblačila.
Intervet Productions S.A. Rue de Lyons 27460 Igoville France
Intervet Productions S.A. Rue de Lyons 27460 Igoville Francija
Avoid contact with skin, eyes and mucous membranes.
Izogibajte se stiku s kožo, očmi in sluznicami.
Colourless high density polyethylene (HDPE) bottle closed with an aluminium/polyester foil seal and a blue child-resistant polypropylene screw cap (1 litre and 4 litre presentations) or type III amber glass bottle with a white polypropylene/polyethylene (PP/PE) child-proof screw cap with expanded low density PE/aluminium foil/ PE faced liner (50 ml presentation).
Brezbarvna plastenka iz polietilena visoke gostote (HDPE), zaprta z aluminijasto/poliestrsko zavarjeno folijo in z modro za otroke varno polipropilensko navojno zaporko (pakiranja 1 liter in 4 litri) ali steklenica iz rumenorjavega stekla tipa III z belo polipropilensko/polietilensko (PP/PE) za otroke varno navojno zaporko z oblogo iz ekspandiranega polietilena (PE) nizke gostote/aluminijasto folijo/PE (50 ml pakiranja).
Determine the duration of time (between 4 and 24 hours) over which to administer the medicated water on the treatment day.
Določite čas (med 4 in 24 urami), v katerem bodo živali dobivale medicirano vodo na dan zdravljenja.
In case of eye contact, immediately rinse thoroughly with water.
V primeru stika z očmi oči takoj temeljito spirajte z vodo.
Shelf life of the medicated drinking water: 24 hours.
Rok uporabnosti medicirane vode za pitje: 24 ur.
Fluralaner is widely distributed throughout the body, with the highest concentrations reported in the liver and skin/fat.
Fluralaner se v veliki meri porazdeli po vsem telesu, najvišje koncentracije pa doseže v jetrih in koži/maščobi.
Fluralaner is an acaricide and an insecticide which has a high potency against poultry mites, mostly by exposure via feeding, i.e. it is systemically active against the target parasites.
Fluralaner je akaricid in insekticid, ki ima močen učinek proti pršicam perutnine, večinoma z izpostavljanjem preko hranjenja, tj., je sistemsko aktiven proti ciljnim parazitom.
Medicines should not be disposed of via wastewater or household waste.
Ne odvrzite zdravila v odpadno vodo ali gospodinjske odpadke.
The excipients listed in section 6.1 of the SPC are 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.
Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
Fluralaner Poultry 65 µg/kg 650 µg/kg
Terapevtska indikacije fluralaner fluralaner perutnina 65 µg/kg 650 µg/kg
Fluralaner is highly bound to protein.
Fluralaner se močno veže na plazemske beljakovine.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
A. PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
The onset of activity against Dermanyssus gallinae is within four hours of the mites starting to feed on treated chickens.
Aktivnost proti Dermanyssus gallinae se začne v štirih urah po tem, ko se pršice začnejo hraniti na zdravljenih piščancih.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v tem navodilu za uporabo, če menite da zdravilo ni delovalo, obvestite svojega veterinarja.
Fluralaner is a potent inhibitor of parts of the arthropod nervous system by acting antagonistically on ligand-gated chloride channels (GABA-receptor and glutamate-receptor).
Fluralaner je močan inhibitor delov artropodnega živčnega sistema, s tem da antagonistično deluje na ligand odvisne kloridne kanale (GABA receptor in receptor glutamata).
It is important to rinse the measuring device used to measure the required product volume during the filling phase in order to ensure that the complete dose is emptied into the medication tank or the stock solution and that no residues remain in the measuring device.
Pomembno je, da sperete merilno napravo, ki ste jo uporabili za merjenje potrebne količine zdravila med polnjenjem, da zagotovite, da je celotni odmerek izpraznjen v rezervoar za medicirano vodo ali v zalogo raztopine in da v merilni napravi ni nobenih ostankov.
In vitro bio-assays show that fluralaner is effective against parasites having proven field resistance, including organophosphates, pyrethroids and carbamates.
In vitro bio-testi kažejo, da je fluralaner učinkovit proti parazitom, pri katerih je bila dokazana odpornost na terenu, vključno z organofosfati, piretroidi in karbamati.
To ensure administration of the correct dose, the body weight should be determined as accurately as possible and an accurate measuring device should be used for measuring the calculated volume of the product to be administered.
Da bo odmerek zagotovo pravilen, je treba telesno maso določiti čim bolj natančno in za merjenje izračunane količine zdravila, ki ga boste dodali vodi za pitje, uporabiti natančno merilno napravo.
No significant metabolites are observed in chickens, and fluralaner is mainly eliminated via the hepatic route.
Pri piščancih ni opaziti pomembnih metabolitov in fluralaner se v glavnem izloči preko jeter.
The apparent elimination half-life is approximately 5 days following oral administration.
Razpolovna doba je približno 5 dni po peroralnem dajanju.
• Prime the drinker lines with medicated water and check to see when medicated water has reached the end of the line.
• Napolnite napajalne vode z medicirano vodo in kontrolirajte, kdaj bo medicirana voda dosegla konec napajalnega voda.
Fluralaner degrades in aquatic sediment under anaerobic conditions while it has been shown to be very persistent under aerobic conditions.
Fluralaner se razgradi v vodnem sedimentu pod anaerobnimi pogoji, medtem ko se je izkazalo, da je zelo obstojen pod aerobnimi pogoji.
Environmental properties:
Okoljske lastnosti:
After each treatment administration, fill the stock solution container with clean (unmedicated) water to rinse the water lines.
Po vsakem dajanju zdravila napolnite posodo z zalogo raztopine s čisto (nemedicirano) vodo, da sperete napajalne vode.
For use in drinking water.
Za dajanje v vodo za pitje.
The safety of the veterinary medicinal product has been demonstrated in layers and breeders.
Varnost zdravila za uporabo v veterinarski medicini je bila dokazana pri kokoših nesnicah in matičnih jatah.
Meat and offal: 14 days.
Meso in organi: 14 dni.
Alpha-tocopherol (all-rac-α-tocopherol) Diethylene glycol monoethyl ether Polysorbate 80
Seznam pomožnih snovi alfatokoferol (vseracemni-α-tokoferol) dietilenglikolmonoetileter polisorbat 80
EXP {month/year} Once opened, use within 1 year.
EXP {mesec/leto} Odprto zdravilo uporabite v 1 letu.
Volume of product (ml) per treatment day = Total body weight (kg) of chickens to be treated x 0.05 ml/kg
količina zdravila (ml) za dan zdravljenja = celokupna telesna masa (kg) piščancev, ki jih boste zdravili, x 0,05 ml/kg
Pharmacotherapeutic group: Antiparasitic products, ectoparasiticides for systemic use, isoxazolines.
Farmakoterapevtska skupina: antiparazitiki, učinkovine proti ektoparazitom za sistemsko zdravljenje, izoksazolini.
In molecular on-target studies on insect gamma-aminobutyric acid (GABA) receptors of flea and fly, dieldrin resistance does not affect fluralaner.
V molekularnih ciljanih študijah na receptorjih gama-aminomaslene kisline (GABA) bolh in muh, odpornost na dieldrin ne vpliva na delovanje fluralanerja.
Exzolt should not enter water courses as this may be dangerous for aquatic invertebrates.
Zdravilo Exzolt ne sme priti v vodotoke, ker je to lahko nevarno za vodne organizme.
Target tissues Other provisions
Ciljna tkiva Druge določbe
The required volume of product for each treatment day is calculated from the total body weight (kg) of the entire group of chickens to be treated:
Potrebno količino zdravila za vsak dan zdravljenja izračunate iz celokupne telesne mase (kg) cele skupine piščancev, ki jih boste zdravili:
The product should be added to a volume of water that the chickens will consume in one day.
Zdravilo je treba dodati količini vode, ki jo bodo živali popile v enem dnevu.
To ensure long term control of the mite populations in a treated house, it is essential to treat any other infested poultry in houses in proximity to the treated one.
Da bi zagotovili dolgotrajen nadzor pršic v zdravljenem hlevu, je bistvenega pomena, da zdravimo tudi vso ostalo perutnino v hlevih, ki so v bližini zdravljenega.
The treatment kills mites feeding on treated chickens and stops egg production from female mites for 15 days after the first administration of the product.
Zdravljenje ubije pršice, ki se hranijo na zdravljenih piščancih in ustavi proizvodnjo jajčec pri samicah pršic za 15 dni po prvem dajanju zdravila.
Fluralaner has been shown to be very persistent in soil under both, aerobic and anaerobic conditions.
Izkazalo se je, da je fluralaner zelo obstojen v zemlji, tako v aerobnih kot anaerobnih pogojih.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smete mešati z drugimi zdravili za uporabo v veterinarski medicini.
The instructions below need to be followed, in the order described, to prepare the medicated water:
Za pripravo medicirane vode je treba upoštevati naslednja navodila po opisanem vrstnem redu:
The bioavailability is high, with approximately 91% of the dose absorbed following oral administration.
približno 91% resorbiranega odmerka po peroralnem dajanju.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE DOVOLJENJA ZA PROMET/ PODALJŠANJE DOVOLJENJA DOVOLJENJA ZA PROMET
EU/2/17/212/001 (1 litre) EU/2/17/212/002 (4 litres)
EU/2/17/212/002 (4 litri)
Antiparasitic agents/Agents against ectoparasites
NI VPISA Antiparazitska sredstva/sredstva proti ektoparazitom
Once diluted use within 24 hours.
Razredčeno zdravilo uporabite v 24 urah.
Treatment of poultry red mite (Dermanyssus gallinae) infestation in pullets, breeders and layer hens.
Zdravljenje infestacije rdečih pršic perutnine (Dermanyssus gallinae) pri jarkicah, matičnih jatah in kokoših nesnicah.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
o Mix the required volume of the product with water into a large medication tank or create a stock solution in a small container.
o Zmešajte potrebno količino zdravila z vodo v velik rezervoar za medicirano vodo ali pripravite zalogo raztopine v majhni posodi.
Wash hands and contacted skin with soap and water after use of the product.
Po uporabi zdravila si umijte roke in kožo, ki je bila v stiku z zdravilom, z milom in vodo.
Bottle of 50 ml, 1 litre or 4 litres.
Steklenica s 50 ml, plastenka z 1 litrom ali 4 litri.
Muscle Skin and fat in natural proportions Liver
1300 µg/kg mišice koža in maščoba v naravnih razmerjih jetra ledvice jajca
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
The active substance in Exzolt is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Učinkovina v zdravilu Exzolt je dovoljena učinkovina, kot je navedena v tabeli 1 priloge Uredbe
Estimate how much water birds will consume during treatment based on the previous day's water consumption.
Na podlagi porabe vode prejšnjega dne ocenite, koliko vode bodo živali popile med zdravljenjem.
The product can be used during lay.
Zdravilo se lahko uporablja v obdobju nesnosti.
10 mg fluralaner For the full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Fertility and lay:
Plodnost in nesnost:
Connect the medication tank or the proportioner or dosing pump to the drinking water system.
Spojite rezervoar za medicirano vodo ali odmernik ali odmerno črpalko na sistem vode za pitje.
CARTON BOX (50-ml presentation only)
Kartonska škatla (samo 50-ml pakiranja)
Calculate the volume of product needed based on the total weight of all birds in the house to be treated.
Izračunajte količino potrebnega zdravila na podlagi celokupne mase vseh piščancev v hlevu, ki jih boste zdravili.