natgillin/translations-raw huggingface dataset:
Trifexis can be used as part of the seasonal prevention of fleas (replacing treatment with a monovalent flea product) in dogs with diagnosed concurrent gastrointestinal nematode infections.
Zdravilo Trifexis se lahko uporablja kot del sezonske preventive proti bolham (namesto zdravljenja z monovalentnim izdelkom proti bolham) pri psih z diagnozo sočasne okužbe prebavil z želodčnočrevesnimi nematodi.
Based on the local epidemiological situation, the veterinary medicinal product may be given at monthly intervals throughout the season at the recommended dose as outlined below.
Glede na lokalne epidemiološke okoliščine se lahko to zdravilo v priporočenih odmerkih daje v mesečnih intervalih skozi vso sezono, kakor je opisano spodaj.
It is active against mites, larval and adult stages of nematodes as well as larvae of Dirofilaria immitis.
Deluje proti pršicam, odraslim nematodom in njihovim ličinkam, kot tudi proti ličinkam filarije Dirofilaria immitis.
Mottled tan to brown, round, biconvex tablets with a debossed code on one side and dimples on the other side.
Lisaste rumenorjave do rjave, okrogle, bikonveksne tablete z vtisnjeno oznako na eni strani in vdolbinicami na drugi strani.
In studies performed with spinosad only, the primary biliary, faecal and urinary metabolites in both rat and dog were identified as the demethylated spinosyns, glutathione conjugates of the parent compounds and N-demethylated spinosyns A and D. Excretion is primarily via the bile and faeces, and to a lesser extent in the urine.
V študijah, opravljenih s samim spinosadom, so glavne presnovke v žolču, blatu in urinu pri podganah in psih opredelili kot demetilirane spinosine, glutationske konjugate starševskih spojin in Ndemetilirana spinosina A in D. Glavna pot izločanja je z žolčem in blatom, v manjši meri pa z urinom.
After oral administration of 45 mg spinosad and 0.75 mg milbemycin oxime/kg bodyweight to fed dogs, spinosyns A and D are rapidly absorbed and extensively distributed.
Po peroralni uporabi 45 mg spinosada in 0,75 mg milbemicin oksima/kg telesne mase pri nahranjenih psih se spinosina A in D hitro absorbirata in obsežno porazdelita.
At doses of 30 to 60 mg spinosad and 0.5 to 1 mg milbemycin oxime per kg bodyweight, lethargy, anorexia/decreased appetite, diarrhoea, pruritus, dermatitis and reddening of the skin and pinna were commonly seen.
Pri odmerkih od 30 do 60 mg spinosada in 0,5 do 1 mg milbemicin oksima na kg telesne mase so se pogosto pojavili tudi letargija, anoreksija/zmanjšanje apetita, diareja, pruritus, dermatitis ter pordelost kože in uhljev.
For the prevention of lungworm disease by reducing the level of infection with immature adult (L5) Angiostrongylus vasorum larvae and the concurrent treatment and prevention of flea infestation, the veterinary medicinal product must be given at regular monthly intervals during the time of the year when snails/slugs and fleas are present.
Za preprečevanje angiostrongiloze z zmanjšanjem stopnje okužbe z nezrelo odraslo obliko (L5) Angiostrongylus vasorum larve ter sočasno zdravljenje in preprečevanje infestacij z bolhami je treba to zdravilo dajati v rednih mesečnih intervalih v tistem obdobju leta, ko so prisotni polži in bolhe.
Spinosad and milbemycin oxime have been shown to be substrates for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones.
Dokazano je, da sta spinosad in milbemicin oksim substrata za P-glikoprotein (P-gp), zato lahko medsebojno delujeta z drugimi P-gp substrati (npr. digoksinom in doksorubicinom) ali drugimi makrocikličnimi laktoni.
PHARMACEUTICAL FORM Chewable tablets
FARMACEVTSKA OBLIKA Žvečljive tablete.
The primary faecal and urinary metabolites in dog were identified as glucuronide conjugates of milbemycin A3 or A4 5-oximes, dealkylated milbemycin A3 or A4 5-oximes, and hydroxylated milbemycin A4 5-oxime.
Glavne presnovke v blatu in urinu pri psih so opredelili kot glukuronidne konjugate milbemicina A3 ali A4 5-oksima, dealkiliranega milbemicin A3 ali A4 5-oksima in hidroksiliranega milbemicin A4 5oksima.
Milbemycin oxime is isolated from the fermentation of Streptomyces hygroscopicus var. aureolacrimosus.
Izoliran je iz fermentacije z bakterijsko vrsto Streptomyces hygroscopicus var. aureolacrimosus.
It is recommended to observe the treated dog up to 24 hours post-administration of the product for possible adverse reactions (see section 6).
Priporočamo vam, da zdravljenega psa opazujete do 24 ur po uporabi zdravila zaradi možnih neželenih učinkov (glejte poglavje 6).
Bodyweight (kg) of dog
Telesna masa psa (kg)
At doses in excess of the recommended dose, vomiting becomes a very common event.
Pri odmerkih, ki presegajo priporočenega, se bruhanje pojavlja zelo pogosto.
Milbemycin A4 5-oxime tends to eliminate slower resulting in approximately 10-fold higher exposure than Milbemycin A3 5-oxime.
Milbemicin A4 5-oksim se izloča počasneje, zato je izpostavljenost približno 10-krat večja v primerjavi z milbemicin A3 5-oksimom.
Use with caution in dogs with pre-existing epilepsy.
Previdnost je potrebna pri psih z epilepsijo.
The following list shows the code and the number of dimples marked on each strength of tablet: Trifexis 270 mg/4.5 mg tablets:
Na naslednjem seznamu so oznake in število vdolbinic na tabletah različnih jakosti: Trifexis 270 mg/4,5 mg tablete:
The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 45 to 70 mg spinosad and 0.75 to 1.18 mg milbemycin oxime/kg bodyweight.
Zdravilo se daje skladno z naslednjo tabelo, da se zagotovita odmerek spinosada 45-70 mg/kg telesne mase in odmerek milbemicin oksima 0,75-1,18 mg/kg telesne mase.
Manufacturer responsible for batch release: Eli Lilly and Company Ltd Speke Operations
Izdelovalec, odgovoren za sproščanje serij: Eli Lilly and Company Ltd Speke Operations
Based on the local epidemiological situation and the decision of the prescribing veterinarian, the veterinary medicinal product may be given at monthly intervals throughout the season at the recommended dose as outlined below.
Glede na lokalne epidemiološke okoliščine in po presoji odgovornega veterinarja se lahko to zdravilo v priporočenih odmerkih daje v mesečnih intervalih skozi vso sezono, kakor je opisano spodaj.
Prior to first use of this product, dogs in heartworm endemic areas or who have visited heartworm endemic areas must be tested for existing heartworm infection.
Pred prvo uporabo tega zdravila je treba pse, ki živijo na endemičnih območjih za srčno glisto ali ki so tako območje obiskali, testirati na obstoječo okužbo z glisto.
The excretion of milbemycin oxime in lactating dogs (bitches) has not been tested and the safety for suckling puppies has not been established.
Izločanje milbemicin oksima pri psicah v laktaciji ni preverjeno in varnost za mladiče, ki sesajo materino mleko, ni ugotovljena.
Dogs living in non-heartworm endemic areas:
Psi, ki živijo na območjih, ki niso endemična za srčno glisto:
In dogs, hydroxymilbemycin A4 5-oxime was detected only in plasma, but not in urine or faeces, suggesting predominant excretion of conjugated metabolites in the dog.
Pri psih so odkrili hidroksimilbemicin A4 5-oksim samo v plazmi, ne pa tudi v urinu in blatu, kar kaže, da se pri psih izločajo predvsem konjugirani presnovki.
Dogs travelling to a heartworm region should start medication within a month after arrival there.
Pse, ki bodo obiskali endemično območje za srčno glisto, je treba začeti zdraviti najpozneje en mesec po prihodu na to območje.
After spinosad administration, the incidence of vomiting on the day of, or the day after dosing has been observed to increase as a function of the dose.
Opazili so, da se je po dajanju spinosada pojavnost bruhanja na dan odmerjanja ali naslednji dan povečala sorazmerno z odmerkom.
No studies have been performed in sick or convalescent dogs, therefore the product should only be used based on a benefit-risk assessment of the responsible veterinarian.
Pri bolnih in psih v okrevanju niso izvedli nobenih študij, zato se sme zdravilo uporabljati samo na podlagi ocene koristi in tveganj, ki jo opravi odgovorni veterinar.
Approximately 90% of spinosad is comprised of spinosyns A and D. Of that 90%, the ratio of spinosyn A to A+D is 0.85 when calculated as spinosyn A/spinosyn A+D.
Približno 90 % spinosada sestavljata spinosina A in D. Od teh 90 % je razmerje med spinosinom A in A + D 0,85, če se izračuna kot spinosin A/spinosin A + D. Konsistentnost te številke v farmakokinetičnih in drugih študijah kaže na primerljivost absorpcije, presnove in izločanja dveh glavnih spinosinov.
Special precautions for each target species:
Posebna opozorila za vsako živalsko vrsto:
The safe use of the maximum recommended dose (70 mg/kg spinosad and 1.18 mg/kg milbemycin oxime) given as capsules has been demonstrated for 12 months.
Varno uporabo največjega priporočenega odmerka (70 mg/kg spinosada in 1,18 mg/kg milbemicin oksima), danega v obliki kapsul, so dokazali za obdobje 12 mesecev.
Regular monthly treatments with the insecticidal active substance in this product (spinosad) break the fleas' life cycle and may be used to control the flea population in contaminated households.
Redna mesečna uporaba insekticidne učinkovine v tem zdravilu (spinosada) prekine življenjski cikel bolhe in se lahko uporablja za nadzor populacije bolh v okuženih gospodinjstvih.
Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings.
Bolhe domačih živali pogosto infestirajo košaro živali, ležišče in prostore, v katerih žival redno počiva, kot so preproge in oblazinjeno pohištvo.
Treatment and prevention of flea infestation when concurrent prevention of heartworm disease, angiostrongylosis and/or concurrent treatment of nematode infections is indicated.
Zdravljenje in preprečevanje infestacij z bolhami, kadar je indicirano sočasno preprečevanje dirofilarioze, angiostrongiloze in/ali sočasno zdravljenje okužb z nematodi.
Milbemycin A3 and A4 5-oximes are rapidly absorbed and extensively distributed in dogs after oral administration.
Milbemicin A3 in A4 5-oksimi se pri psih po peroralni uporabi hitro absorbirajo in obsežno porazdelijo.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
Prior to first administration, dogs in heartworm endemic areas or who have visited heartworm endemic areas must be tested for existing heartworm infection.
Pred prvim dajanjem je treba pse, ki živijo na endemičnih območjih za srčno glisto ali ki so tako območje obiskali, testirati na obstoječo okužbo z glisto.
NAME OF THE MARKETING AUTHORISATION HOLDER Eli Lilly and Company Ltd
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly and Company Ltd
Microcrystalline cellulose Hydroxypropyl cellulose Silica, colloidal anhydrous Croscarmellose sodium Magnesium stearate Artificial beef flavour
6.1 Seznam pomožnih snovi mikrokristalna celuloza hidroksipropilceluloza brezvodni koloidni silicijev dioksid natrijeva kroskarmeloza magnezijev stearat umetna aroma govedine
Safe use in overdose situations up to 3.6 times the recommended dose has been demonstrated following 6 monthly administrations.
Varnost zdravila pri prevelikem odmerjanju z do 3,6-kratnim največjim priporočenim odmerkom zdravila so dokazali po 6 mesečnih odmerjanjih.
Marketing authorisation holder: Eli Lilly and Company Ltd Elanco Animal Health Priestley Road
Imetnik dovoljenja za promet z zdravilom: Eli Lilly and Company Ltd Elanco Animal Health Priestley Road
The following list shows the code and the number of dimples marked on each strength of tablet:
Na naslednjem seznamu so oznake in število vdolbinic na tabletah različnih jakosti:
For the prevention of heartworm disease and the concurrent treatment and prevention of flea infestations, the veterinary medicinal product must be given at regular monthly intervals during the time of the year when mosquitoes and fleas are present.
Za preprečevanje dirofilarioze ter sočasno zdravljenje in preprečevanje infestacij z bolhami je treba to zdravilo dajati v rednih mesečnih intervalih v tistem obdobju leta, ko so prisotni komarji in bolhe.
Regular monthly treatments with the insecticidal active substance, spinosad, break the fleas' life cycle and may be used to control the flea population in contaminated households.
Redna mesečna uporaba insekticidne učinkovine spinosad prekine življenjski cikel bolhe in se lahko uporablja za nadzor populacije bolh v okuženih gospodinjstvih.
Laboratory studies on the effect of spinosad and milbemycin oxime in rats and rabbits have neither produced any evidence of teratogenic, foetotoxic or maternotoxic effects, nor any effect on the reproductive capacity in males and females.
Laboratorijske študije učinkov spinosada in milbemicin oksima na podganah in kuncih niso dokazale teratogenih in fetotoksičnih učinkov, toksičnih učinkov na mater ali učinkov na sposobnost razmnoževanja samcev in samic.
Carton containing 1 blister pack.
Škatla vsebuje en pretisni omot.
Dogs living in heartworm endemic areas:
Psi, ki živijo na endemičnih območjih za srčno glisto:
Parasite resistance to any particular class of anthelmintic may develop following the frequent, repeated use of an anthelmintic of that class.
Po pogosti, ponavljajoči se uporabi antihelmintika istega razreda lahko zajedavci razvijejo odpornost na ta razred antihelmintika.
AUC values increased approximately linearly while Cmax increased slightly less than linearly with increasing dose-rates over the intended therapeutic dose range.
Vrednosti AUC so z naraščanjem stopenj odmerkov v nameravanem razponu terapevtskih odmerkov naraščale skoraj linearno, vrednosti Cmax pa nekoliko manj kot linearno.
The tablets are a mottled tan to brown colour, and are round and chewable.
Tablete so lisaste, rumenorjave do rjave barve, okrogle in žvečljive.
If a dose is missed, administer the veterinary medicinal product with the next offering of food.
Če izpustite odmerek, dajte psu zdravilo z naslednjim obrokom hrane.
If the dog does not accept the tablet(s) directly in its mouth then the tablet(s) may be mixed with food.
V primeru, da pes ne zaužije celih tablet(e), mu jo(jih) lahko zmešamo v hrano.
Laboratory studies (in rats and rabbits) on the effect of spinosad and milbemycin oxime have neither produced any evidence of teratogenic, foetotoxic or maternotoxic effects, nor any effect on the reproductive capacity in males and females.
Laboratorijske študije (na podganah in kuncih) učinkov spinosada in milbemicin oksima niso dokazale teratogenih in fetotoksičnih učinkov, toksičnih učinkov na mater ali učinkov na sposobnost
The flea preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the veterinary medicinal product.
Učinek preprečevanja ponovnih infestacij z bolhami je rezultat insekticidnega delovanja na odrasle oblike in zmanjšanja tvorbe jajčec, ki se po dajanju zdravila ohrani do 4 tedne.
Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control, therefore, to minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each season prior to starting monthly preventive treatments.
Da se zmanjša tveganje za razvoj odpornosti, se priporoča, da pred začetkom vsake sezone, preden začnete z mesečnim preventivnim zdravljenjem, pregledate, ali imajo psi v obtoku antigene in mikrofilarije.
Monthly repeated oral administration of spinosad and milbemycin oxime over six months revealed evidence of spinosad and milbemycin oxime accumulation in juvenile dogs.
Ponavljajoče se mesečno peroralno dajanje spinosada in milbemicin oksima, ki je trajalo več kot šest mesecev, je pri mladih psih razkrilo dokaze o kopičenju spinosada in milbemicin oksima.
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
DRUGI POGOJI IN ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
The oral administration of spinosad and milbemycin oxime combination tablets at mean cumulative monthly doses of up to 255 mg spinosad and 4.2 mg milbemycin oxime per kg body weight (up to 3.6 times the maximum recommended dose) for 6 consecutive dosing periods in young dogs was well tolerated.
Mladi psi so dobro prenašali peroralno dajanje kombiniranih tablet spinosada in milbemicin oksima v povprečnih kumulativnih mesečnih odmerkih do 255 mg spinosada in 4,2 mg milbemicin oksima na kg telesne mase (do 3,6-kratni največji priporočeni odmerek) v 6 zaporednih obdobjih odmerjanja.
It is recommended to observe the treated dog up to 24 hours post-administration of the product for possible adverse reactions (see section 4.6).
Zaradi možnih neželenih učinkov je priporočeno zdravljenega psa opazovati do 24 ur po uporabi zdravila (glejte poglavje 4.6).
For the treatment and prevention of flea (Ctenocephalides felis) infestations in dogs where one or more of the following indications are required concurrently: - prevention of heartworm disease (L3, L4 Dirofilaria immitis), - prevention of angiostrongylosis by reducing the level of infection with immature adult (L5)
Za zdravljenje in preprečevanje infestacij z bolhami (Ctenocephalides felis) pri psih, kjer se sočasno pojavlja ena ali več naslednjih indikacij: - preprečevanje dirofilarioze (L3, L4 Dirofilaria immitis), - preprečevanje angiostrongiloze z zmanjšanjem stopnje okužbe z nezrelo odraslo obliko (L5) nematoda Angiostrongylus vasorum, - zdravljenje okužb z želodčno-črevesnimi nematodi, ki jih povzročajo kavljasti črvi (L4, nezrele odrasle oblike (L5) in odrasle oblike Ancylostoma caninum), valjasti črvi (nezrele odrasle oblike L5 in odrasle oblike Toxocara canis ter odrasle oblike Toxascaris leonina) in bičeglavci (odrasle oblike Trichuris vulpis).
The veterinary medicinal product should be administered with food or immediately after feeding.
Zdravilo dajemo s hrano ali takoj po obroku.
As the safety of the veterinary medicinal product in male dogs used for breeding has not been determined, it should only be used according to the benefit-risk assessment of the responsible veterinarian.
Ker varnost zdravila pri pasjih samcih za razplod še ni ugotovljena, se sme to zdravilo uporabljati samo skladno z oceno razmerja med koristmi in tveganji, ki jo opravi odgovorni veterinar.
4347 and no dimples
4347 in brez vdolbinic
In rats dosed with milbemycin A4 5-oxime, the main metabolites identified in urine and faeces were mono-, di-, and trihydroxy milbemycin A4 5-oximes.
Ipodganah, ki so dobivale milbemicin A4 5-oksim, so kot glavne presnovke v urinu in blatu opredelili mono-, di- in trihidroksi milbemicin A4 5-oksime.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
In adult dogs, after repeated oral administration of spinosad and milbemycin oxime for six consecutive months, increases in elimination half-lives were observed up to month 3.
Pri odraslih psih večkratno peroralno dajanje spinosada in milbemicin oksima za šest zaporednih mesecev povzroči povečanje končnega razpolovnega časa do 3. meseca.
In juvenile dogs, repeated oral administration of spinosad and milbemycin oxime over six months resulted in the trough plasma concentrations of spinosad and milbemycin increasing throughout the study.
Pri mladih psih je večkratno šestmesečno peroralno dajanje spinosada in milbemicin oksima povzročilo povečevanje najnižje koncentracije spinosada in milbemicin oksima v plazmi ves čas študije.
4349 and 4 dimples
4349 in 4 vdolbinice
Dosage:
Odmerjanje:
Post-marketing reports following the concomitant use of spinosad with ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Izkušnje uporabe zdravila kažejo, da je prišlo pri psih ob sočasni uporabi spinosada z ivermektinom do tresenja/trzanja, salivacije/slinjenja, epileptičnih napadov, ataksije, midriaze, slepote in dezorientacije.
This product should therefore only be used during pregnancy and lactation according to the benefit-risk assessment of the responsible veterinarian.
Zato se sme v obdobju brejosti ali laktacije to zdravilo uporabljati samo skladno z oceno razmerja med koristmi in tveganji, ki jo opravi odgovorni veterinar.
Spinosad starts killing fleas 30 minutes after administration; 100% of fleas are dead/moribund within 4 hours post-treatment.
Spinosad začne pobijati bolhe 30 minut po dajanju.
Fleas may be observed for a period of time after administration of the veterinary medicinal product due to the emergence of adult fleas from pupae already present in the environment.
Bolhe se lahko zaradi razvoja odraslih bolh iz bub, ki so že v okolju, pojavljajo še nekaj časa tudi v obdobju po dajanju zdravila.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
BESEDILO »ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM« Zdravilo shranjujte nedosegljivo otrokom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH PRETISNI OMOT
4333 and 2 dimples
4333 in 2 vdolbinici
EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg)
EU/2/13/155/001 (1 tableta, 270 mg/4,5 mg) EU/2/13/155/002 (1 x 3 tablete, 270 mg/4,5 mg) EU/2/13/155/003 (1 x 6 tablet, 270 mg/4,5 mg) EU/2/13/155/004 (1 tableta, 425 mg/7,1 mg) EU/2/13/155/005 (1 x 3 tablete, 425 mg/7,1 mg) EU/2/13/155/006 (1 x 6 tablet, 425 mg/7,1 mg) EU/2/13/155/007 (1 tableta, 665 mg/11,1 mg)
EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg) EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 tablets, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 tablets, 665 mg/11.1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 tablets, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 tablets, 1040 mg/17.4 mg) EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg) EU/2/13/155/014 (1 x 3 tablets, 1620 mg/27.0 mg) EU/2/13/155/015 (1 x 6 tablets, 1620 mg/27.0 mg)
EU/2/13/155/001 (1 tableta, 270 mg/4,5 mg) EU/2/13/155/002 (1 x 3 tablete, 270 mg/4,5 mg) EU/2/13/155/003 (1 x 6 tablet, 270 mg/4,5 mg) EU/2/13/155/004 (1 tableta, 425 mg/7,1 mg) EU/2/13/155/005 (1 x 3 tablete, 425 mg/7,1 mg) EU/2/13/155/006 (1 x 6 tablet 425 mg/7,1 mg) EU/2/13/155/007 (1 tableta, 665 mg/11,1 mg) EU/2/13/155/008 (1 x 3 tablete, 665 mg/11,1 mg) EU/2/13/155/009 (1 x 6 tablet, 665 mg/11,1 mg) EU/2/13/155/010 (1 tableta, 1040 mg/17,4 mg) EU/2/13/155/011 (1 x 3 tablete, 1040 mg/17,4 mg) EU/2/13/155/012 (1 x 6 tablet, 1040 mg/17,4 mg) EU/2/13/155/013 (1 tableta, 1620 mg/27,0 mg) EU/2/13/155/014 (1 x 3 tablete, 1620 mg/27,0 mg) EU/2/13/155/015 (1 x 6 tablet, 1620 mg/27,0 mg)
In addition, in studies containing only spinosad, AUC and Cmax values were higher in fed than fasted dogs and therefore it is recommended to treat dogs with food as this maximises the opportunity for fleas to ingest lethal amounts of spinosad.
Poleg tega so bile v študijah s samim spinosadom vrednosti AUC in Cmax višje pri nahranjenih psih kot pri teščih.
6.5 Nature and composition of immediate packaging Blister packs (of 1, 3 or 6 chewable tablets) in a carton.
Pretisni omoti (z 1, s 3 ali 6 žvečljivimi tabletami) v kartonski škatli.
4346 and 3 dimples
4346 in 3 vdolbinice
4336 and 5 dimples
4336 in 5 vdolbinic