natgillin/translations-raw huggingface dataset:
The treatment of a vomiting dog should be started with the injection, since vomiting animals might not be able to keep a tablet down (as they might throw the intact tablet up again).
Zdravljenje psa, ki bruha, je treba začeti z injekcijo, kajti bruhajoče živali morebiti ne bi mogle pogoltniti tablete (nepoškodovano tableto bi utegnile ponovno izvreči).
Also, the treatment of vomiting should only be together with other supportive measure or other veterinary therapy while addressing the underlying causes of the vomiting.
Poleg tega je treba zdravljenje bruhanja izvajati samo skupaj z drugimi podpornimi ukrepi ali drugim veterinarskim zdravljenjem, pri čemer se je treba posvetiti izvirnim vzrokom bruhanja.
Cerenia was generally well tolerated when administered daily at dosages up to 5 times the recommended doses for an extended period of time (up to 3 times the recommended maximum duration of treatment).
Zdravilo Cerenia so živali na splošno dobro prenašale, kadar so ga v daljšem časovnem obdobju (do trikrat daljšem od priporočenega najdaljšega trajanja zdravljenja) dajali v dnevnih odmerkih, ki so do petkrat presegali priporočene odmerke.
A common side effect in the high dose group of 8 mg/ kg (motion sickness) was vomiting before the car journey started.
Pogost stranski učinek pri skupini, ki je prejemala velike odmerke v velikosti 8 mg/ kg (slabost zaradi vožnje), je bilo bruhanje, preden se je vožnja z avtomobilom začela.
Since this was mainly observed in dogs with an empty stomach, it is recommended to feed a light meal or snack a while before the tablets are given.
Ker so to ugotavljali predvsem pri psih, ki so imeli prazen želodec, je priporočljivo živalim dati lahek obrok ali zalogaj malo pred dajanjem tablete.
Other reported side effects were decreased activity levels and tiredness.
Drugi stranski učinki, o katerih so poročali, so bili zmanjšana raven aktivnosti in utrujenost.
The active substance in Cerenia, maropitant, is broken down via the liver and it is, therefore, recommended to use it with caution in dogs with liver disease.
Zdravilna učinkovina v zdravilu Cerenia, maropitant, se presnavlja v jetrih, zato je priporočljivo, da se pri psih z obolenji jeter, uporablja previdno.
And because maropitant might affect the heart activity and Cerenia should be used with caution in animals with certain heart conditions.
Ker pa bi maropitant lahko vplival na dejavnost srca, je treba zdravilo Cerenia uporabljati previdno pri živalih, ki imajo določena srčna obolenja.
Since Cerenia has not been studied in very young dogs or pregnant or lactating bitches, any use of Cerenia in these animals should be discussed with your veterinarian.
Ker zdravila Cerenia niso preučevali pri zelo mladih psih ali brejih oziroma doječih psicah, se je treba o vsakršni uporabi zdravila Cerenia pri teh živalih posvetovati z veterinarjem.
Cerenia does not represent a particular risk for people.
Zdravilo Cerenia ne predstavlja posebnega tveganja za ljudi.
However, maropitant can produce acute eye irritation and in the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention.
Vendarle pa maropitant lahko povzroči akutno draženje oči, tako da je treba v primeru nenamernega izpostavljanja oči le- te sprati z obilo vode in poiskati zdravniško pomoč.
In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega zaužitja se je treba nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo zdravila ali etiketo na ovojnini.
Why has Cerenia been approved?
Stran 2 od 3 ©EMEA 2006 Zakaj je bilo zdravilo Cerenia odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Cerenia exceed its risks for the treatment and prevention of vomiting including that induced by chemotherapy or motion sickness, and recommended that Cerenia be given a marketing authorisation.
Zato je priporočil, da se odobri dovoljenje za promet z zdravilom Cerenia.
The benefit-risk balance may be found in module 6 of this EPAR.
Razmerje med koristmi in tveganji najdete v modulu 6 tega EPAR.
The European Commission granted a marketing authorisation valid throughout the European Union, for Cerenia to Pfizer Ltd. on 29/ 09/ 2006.
Evropska komisija je dovoljenje za promet z zdravilom Cerenia, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Ltd. dne 29/ 09/ 2006.
Information on the prescription status of this product may be found on the label/ outer package.
Podatki o predpisovanju tega zdravila so navedeni na etiketi/ zunanji ovojnini.
This summary was last updated on 29/ 09/ 2006
Ta povzetek je bil nazadnje posodobljen 29/ 09/ 2006
Page 2/ 2 ©EMEA 2006
Stran 3 od 3 ©EMEA 2006
Strength Pharmaceutical
Izmišljeno ime
Target
Jakost
Withdrawal
Način uporabe zdravila
Form
Ovojnina
species
Vsebina
Period
Karenca
Blister (Alu/ Alu)
Pretisni omot (aluminij - aluminij)
N/ A
Navedba ni smiselna
160 mg
160 mg Tableta
10 mg/ ml
10 Raztopina za mg/ ml injiciranje
Vial (glass)
Steklena viala
1 TABLETS
1 TABLETE
Cerenia 16 mg tablets for dogs Cerenia 24 mg tablets for dogs Cerenia 60 mg tablets for dogs Cerenia160 mg tablets for dogs
Cerenia 16 mg tablete za pse Cerenia 24 mg tablete za pse Cerenia 60 mg tablete za pse Cerenia 160 mg tablete za pse
Each tablet contains 0.075% w/ w Sunset Yellow (E110) as a colourant For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi, glejte poglavje 6. 1.
Pale orange tablet The tablets have a score line on both sides allowing the tablet to be halved.
Tablete imajo zarezo na obeh straneh, ki omogoča razpolovitev.
Each tablet is marked with the Pfizer logo on the reverse side.
Vsaka tableta je na spodnji strani označena z logotipom Pfizer.
On the obverse side, each half is marked with the letters “ MPT” and figures denoting the quantity of maropitant.
Na zgornji strani je vsaka polovica označena s črkami 'MPT' in številkami, ki označujejo količino maropitanta.
For the prevention of vomiting including that induced by chemotherapy.
Za preprečevanje bruhanja, vključno z bruhanjem, povzročenim s kemoterapijo.
For the treatment of vomiting, in conjunction with Cerenia Solution For Injection and in combination with other supportive measures.
Za zdravljenje bruhanja, v povezavi s Cerenia raztopino za injiciranje in v kombinaciji z ostalimi podpornimi terapijami.
4.4 Special warnings
Posebna opozorila
It is therefore recommended to initiate the treatment of emesis with Cerenia Solution for Injection.
Priporočeno je, da se za prvotno terapijo uporabi Cerenia raztopino za injiciranje.
2 Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures, such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.
2 V skladu z dobro veterinarsko prakso se antiemetike uporablja v povezavi z ostalimi veterinarskimi in podpornimi terapijami, kot je dieta in tekočinska terapija, hkrati pa se zdravi osnovne vzroke bruhanja.
The safety of the veterinary medicinal product has not been established in dogs less than 16 weeks of age and in pregnant or lactating bitches.
Varnost zdravila pri psih, mlajših od 16 tednov, ter v obdobju brejosti in laktacije ni bila dokazana.
Use only according to the benefit/risk assessment by the responsible veterinarian.
Uporabite le v skladu z oceno razmerja korist/ tveganje odgovornega veterinarja.
Cerenia should be used with caution in animals suffering from or with predisposition for cardiac diseases as maropitant has affinity to Ca- and K-ion channels.
Posebna previdnost je potrebna pri uporabi Cerenie pri živalih, ki so predisponirane za kardiološke bolezni, saj ima maropitant afiniteto do Ca - in K - ionskih kanalov.
Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.
Približno 10% povečanje QT intervala ECG so opazili v raziskavi na zdravih psih beaglih, ki so jim aplicirali 8 mg/ kg, vendar pa naj tako povečanje ne bi imelo kliničnega pomena.
Incidents of pre-travel vomiting, usually within two hours post-dosing were commonly reported after administration of the 8 mg/kg dose.
Po dajanju odmerka 8 mg/ kg se je lahko pred vožnjo pojavilo bruhanje, ponavadi v dveh urah po dajanju.
Use only according to the benefit/risk assessment by the responsible veterinarian, because conclusive reproductive toxicity studies have not been conducted in any animal species.
Uporabite le v skladu z oceno razmerja korist/ tveganje odgovornega veterinarja, saj dokončne raziskave reprodukcijske toksičnosti niso bile izvedene pri nobeni živalski vrsti.
Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
Ne uporabljajte Cerenie hkrati z antagonisti Ca kanalov, saj ima maropitant afiniteto do Ca kanalov.
3 For the Treatment and Prevention of Vomiting (except Motion Sickness)
Zdravljenje ter preprečevanje bruhanja (razen slabosti zaradi vožnje)
To treat or prevent vomiting, Cerenia tablets should be administered once daily, at a dose of 2 mg maropitant per kg bodyweight, using the number of tablets given in the table below.
Za zdravljenje ali preprečevanje bruhanja dajemo tablete Cerenia enkrat dnevno v odmerku 2 mg maropitanta na kg telesne teže, uporabimo število tablet, kot je navedeno v tabeli.
Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection once daily for up to five days.
3 Cerenia se uporablja za zdravljenje ali preprečevanje bruhanja v obliki tablet ali raztopine za injiciranje enkrat dnevno do 5 dni.
Treatment and prevention of vomiting (except motion sickness)
Zdravljenje ter preprečevanje bruhanja (razen slabosti zaradi vožnje) Število tablet Telesna teža psa
* Correct dose for dogs of less than 3 kg cannot be accurately achieved.
* za pse, lažje od treh kilogramov, pravi odmerek ni točno določen
For Prevention of Vomiting induced by Motion Sickness
Preprečevanje bruhanja, ki je posledica slabosti zaradi vožnje
To prevent vomiting induced by motion sickness, Cerenia tablets should be administered once daily, at a dose of 8 mg maropitant per kg bodyweight, using the numbers of tablets given in the table below.
Za preprečevanje bruhanja, ki je posledica slabosti zaradi vožnje, dajemo Cerenia tablete enkrat dnevno v odmerku 8 mg maropitanta na kg telesne teže, uporabimo število tablet, kot je navedeno v tabeli.
Number of Tablets
Število tablet Telesna teža psa (kg)
7.6 – 10.0 10.1 – 15.0 15.1 – 20.0
7. 6 – 10. 0 10. 1 – 15. 0 15. 1 – 20. 0 20. 1 – 30. 0 30. 1 – 40. 0 40. 1 – 60. 0
4 As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily repeated administration, lower doses than recommended might be sufficient in some individuals and when repeating the dose.
Zaradi velikega farmakokinetičnega razpona in akumulacije maropitanta v telesu po enkratnem dnevnem dajanju, so lahko, pri določenih živalih ob ponovitvi odmerka, zadostni tudi nižji odmerki od priporočenih.
Cerenia tablets were well tolerated when administered for 15 days at dosages up to 10 mg/kg bodyweight per day.
Živali so Cerenia tablete dobro prenašale tudi po 15- dnevnem dajanju odmerkov do 10 mg/ kg telesne teže na dan.
Clinical signs including vomiting on first administration, excess salivation and watery faeces have been observed when the product has been administered at doses in excess of 20 mg/kg.
Po dajanju odmerka, ki je presegel 20 mg/ kg, so opazili klinične znake, kot so bruhanje po prvem dajanju, prekomerno slinjenje in vodeno blato.
4.11 Withdrawal period(s)
4 4. 11 Karenca
QA04AD90
Farmakoterapevtska skupina: antiemetiki, ATCvet oznaka:
Maropitant is a potent and selective neurokinin (NK-1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family, in the CNS.
QA04AD90 Maropitant je močan in selektiven antagonist neurokinin receptorja (NK- 1), ki inhibira vezavo substance P, tahikininskega neuropeptida, v centralnem živčnem sistemu.
A variety of in vitro assays have demonstrated that maropitant binds selectively at the NK1 receptor with dose-dependent functional antagonism of substance P activity.
Funkcionalni antagonizem aktivnosti substance P je odvisen od odmerka.
In vivo studies in dogs demonstrated the anti-emetic efficacy of maropitant against central and peripheral emetics including apomorphine, cisplatin and syrup of ipecac.
In vivo študije na psih so dokazale antiemetični učinek maropitanta proti centralnim in perifernim emetikom, vključno z apomorfinom, cisplatinom in sirupom ipekakuanje..
5.2 Pharmacokinetic particulars
5. 2 Farmakokinetične posebnosti
The pharmacokinetic profile of maropitant when administered as a single oral dose of 2 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 81 ng/ml; this was achieved within 1.9 hours post-dosing (Tmax).
Za farmakokinetični profil maropitanta, danega psom v enkratnem peroralnem odmerku 2 mg/ kg telesne teže, je značilna najvišja koncentracija (Cmax) v plazmi okoli 81 ng/ ml; ta je dosežena v 1, 9 ure po dajanju (Tmax).
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t0.5) of 4.03 hours.
Vrhu koncentracije sledi upadanje sistemske izpostavitve s polovičnim časom izločitve (t1/ 2) 4, 03 ure.
At a dose of 8 mg/kg, Cmax of 776 ng/ml was reached at 1.7 hours post-dosing.
Pri odmerku 8 mg/ kg je bila Cmax 776 ng/ kg dosežena v 1, 7 ure po dajanju.
The elimination half- life at 8 mg/kg was 5.47 hours.
Polovični čas izločitve je 5, 47 ure.
The inter-individual variation in kinetics may be large, up to 70 CV% for AUC.
Razlike v individualni kinetiki so lahko velike, do 70 CV% AUC.
5 Estimates for the oral bioavailability of maropitant were 23.7% at 2 mg/kg and 37.0% at 8 mg/kg.
Ocena peroralne biorazpoložljivosti maropitanta je 23, 7% pri 2 mg/ kg in 37, 0% pri 8 mg/ kg.
The volume of distribution at steady-state (Vss) determined after intravenous administration at 1 - 2 mg/kg ranged from approximately 4.4 to 7.0 l/kg.
Volumen distribucije v fazi stabilizacije koncentracije (VSS), določen po intravenskem vnosu 1 – 2 mg/ kg je od približno 4, 4 do 7. 0 l/ kg.
Maropitant displays non-linear pharmacokinetics (AUC increases more than proportionally with increasing dose) when administered orally within the 1 - 16 mg/kg dose range.
Maropitant kaže nelinearno farmakokinetiko (AUC raste več kot sorazmerno s povečanjem odmerka) po peroralnem dajanju v odmerku 1 – 16 mg/ kg.
Following repeated oral administration for five consecutive days at a daily dose of 2 mg/kg, accumulation was 151%.
Pri ponavljajočem se peroralnem dajanju 5 zaporednih dni, dnevni odmerek 2 mg/ kg, je akumulacija 151%.
Following repeated oral administration for two consecutive days at a daily dose of 8 mg/kg, accumulation was 218%.
Pri ponavljajočem se peroralnem dajanju 2 zaporedna dneva, dnevni odmerek 8 mg/ kg, je akumulacija 218%.
Renal clearance is a minor route of elimination, with less than 1% of an 8 mg/kg oral dose appearing in the urine as either maropitant or its major metabolite.
Ledvični klirens predstavlja manjši delež izločitve, saj se manj kot 1% peroralnega odmerka 8 mg/ kg izloči z urinom kot maropitant ali njegov metabolit.
Plasma protein binding of maropitant in dogs is more than 99%.
Vezava maropitanta na plazemske proteine pri psih je več kot 99%.
Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sunset Yellow (E110) as a colourant
Natrijev karmelozat, premreženi Laktoza monohidrat Magnezijev stearat Celuloza, mikrokristalna Barvilo sunset rumeno (E110)
Shelf life of the product as packaged for sale:
Rok uporabnosti zdravila v pakiranju za prodajo:
3 years Shelf life of half tablets:
Rok uporabnosti polovice tablete:
Cardboard box containing one aluminium-aluminium blister pack, each containing four tablets per pack.
Kartonska škatlica vsebuje en pretisni omot (aluminij- aluminij) s štirimi tabletami.
Cerenia tablets are available in 16 mg, 24 mg, 60 mg and 160 mg strength.
16 mg, 24 mg, 60 mg ali 160 mg.
EU/2/06/062/001 (16 mg tablets) EU/2/06/062/002 (24 mg tablets) EU/2/06/062/003 (60 mg tablets) EU/2/06/062/004 (160 mg tablets)
EU/ 2/ 06/ 062/ 001 (16 mg tablete) EU/ 2/ 06/ 062/ 002 (24 mg tablete) EU/ 2/ 06/ 062/ 003 (60 mg tablete) EU/ 2/ 06/ 062/ 004 (160 mg tablete)
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.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, EMEA) http: // www. emea. europa. eu /
7 SOLUTION FOR INJECTION
7 DODATEK I
Cerenia 10 mg/ml solution for injection for dogs.
Cerenia 10 mg/ ml raztopina za injiciranje za pse
The solution for injection contains 10 mg maropitant per ml as maropitant citrate monohydrate.
1 ml raztopine za injiciranje vsebuje 10 mg maropitanta v obliki maropitantijevega citrata monohidrata.
The solution for injection contains 3.3 mg/ml metacresol (as preservative).
Raztopina za injiciranje vsebuje 3. 3 mg/ ml metakrezola kot konzervansa.
Solution for injection A clear, colourless to light yellow solution.
Prozorna, brezbarvna do rahlo rumena raztopina.
Although Cerenia has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively.
Čeprav je bila dokazana učinkovitost Cerenie pri zdravljenju in preprečevanju slabosti zaradi kemoterapije, je bolj učinkovita v preventivi.
The use of Cerenia solution for injection against vomiting due to motion sickness is not recommended.
Uporaba Cerenia raztopine za injiciranje proti bruhanju, ki je posledica slabosti zaradi vožnje, ni priporočena.
8 4.5 Special precautions for use
9 4. 5 Posebni previdnostni ukrepi
In the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention
V primeru nenamernega stika z očmi, oči sperite z obilo vode in se posvetujte z zdravnikom.
Pain at injection site may occur.
Na mestu injiciranja se lahko pojavi bolečina.
Cerenia solution for injection should be injected subcutaneously, once daily, at a dose of 1 mg/kg bodyweight (1 ml/10 kg bodyweight).
Cerenia raztopino za injiciranje dajemo enkrat dnevno subkutano, v odmerku 1 mg/ kg telesne teže (1 ml/ 10 kg telesne teže).
Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection once daily for up to five days
Cerenia se za zdravljenje ali preprečevanje bruhanja lahko uporablja v obliki tablet ali raztopine za injiciranje enkrat dnevno do 5 dni.
9 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
10 4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
Cerenia solution for injection was well tolerated in dogs injected daily with up to 5 mg/kg (5 times the use dose) for 15 consecutive days (3-times the recommended duration of administration).
Injiciranje odmerka do 5 mg/ kg (5×večji odmerek od priporočenega) 15 zaporednih dni (3×daljše obdobje od priporočenega) so psi dobro prenašali.
Maropitant is a potent and selective neurokinin (NK-1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family, in the CNS.
QA04AD90 Maropitant je močan in selektiven antagonist neurokinin receptorja (NK- 1), ki inhibira vezavo substance P, tahikininski neuropeptid, v centralnem živčnem sistemu.
A variety of in vitro assays have demonstrated that maropitant binds selectively at the NK1 receptor with dose-dependent functional antagonism of substance P activity.
Funkcionalni anatagonizem aktivnosti substance P je odvisen od odmerka.
Signs of nausea including excessive salivation and lethargy might remain after treatment.
Znaki slabosti, kot je povečano slinjenje in letargija, so lahko prisotni tudi po zdravljenju.
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 92 ng/ml; this was achieved within 0.75 hours post-dosing (Tmax).
Za farmakokinetični profil maropitanta, danega psom v enkratnem subkutanem odmerku 1 mg/ kg telesne teže, je značilna najvišja koncentracija (Cmax) v plazmi okoli 92 ng/ ml; ta je dosežena v 0, 75 ure po dajanju (Tmax).
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 8.84 hours.
Vrhu koncentracije sledi upadanje sistemske izpostavitve s polovičnim časom izločitve (t1/ 2) 8, 84 ure.
The bioavailability of maropitant after subcutaneous administration in dogs was 90.7%.
Biorazpoložljivost maropitanta po subkutanem dajanju je 90, 7%.
The volume of distribution at steady-state (Vss) determined after intravenous administration at 1 - 2 mg/kg ranged from approximately 4.4 to 7.0 L/kg.
Volumen distribucije v fazi stabilizacije koncentracije (VSS), določen po intravenoznem vnosu 1 – 2 mg/ kg je od približno 4, 4 do 7, 0 l/ kg.
Maropitant displays linear kinetics when administered subcutaneously within the 0.5 – 2 mg/kg dose range.
Maropitant kaže linearno kinetiko po subkutanem dajanju v odmerku 0, 5 – 2 mg/ kg.
Following repeated subcutaneous administration of once-daily doses of 1 mg / kg bodyweight for five consecutive days, accumulation was 146%.
Pri ponavljajočem se subkutanem dajanju 5 zaporednih dni, dnevni odmerek 1 mg/ kg telesne teže, je akumulacija 146%.
10 Renal clearance is a minor route of elimination, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine as either maropitant or its major metabolite.
Ledvični klirens predstavlja manjši delež izločitve, saj se manj kot 1% subkutanega odmerka 1 mg/ kg izloči z urinom kot maropitant ali njegov metabolit.
Sulphobutyl ether β-cyclodextrin (SBECD) Water for injections Metacresol (as preservative)
Sulfobutil eter β- ciklodekstrin (SBECD) Voda za injekcije Metakrezol (kot konzervans)
2 years.
2 leti Rok uporabnosti po prvem odpiranju stične ovojnine:
Once broached, use within 28 days.
28 dni.
20 ml, amber molded glass type 1 vial, chlorobutyl rubber stopper and aluminium overseal with flip- off button.
20 ml steklena viala, steklo tipa I, jantarjeve barve, zaprta s klorobutilnim gumijastim zamaškom in aluminijastim pokrovčkom z zaporko.
Each cardboard outer contains 1 vial.
Vsaka kartonska škatlica vsebuje eno vialo.
11 10.
12 10.
18.11.2008
PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Navedba ni smiselna.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
I. de Pocé 29 route des Industries F-37530 Pocé sur Cisse France
I. de Poce 29 route des Industries F- 37530 Poce sur Cisse Francija
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Imetnik tega dovoljenja za promet mora obvestiti Evropsko Komisijo o marketinškem načrtu za zdravilo, ki je predmet tega dovoljenja.
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
OZNAČEVANJE
CARDBOARD CARTON / Tablets
KARTONSKA ŠKATLICA / Tablete
Cerenia 16 mg tablets for dogs
Cerenia 16 mg tablete za pse
The tablets also contain Sunset yellow (E110) as a colourant.
Tablete vsebujejo barvilo sunset rumeno (E110).
2 mg/kg bodyweight for prevention and treatment of vomiting 8 mg/kg bodyweight for motion sickness.
8 mg/ kg telesne teže pri slabosti zaradi vožnje.
It is recommended to initiate treatment of emesis with Cerenia Solution for Injection.
Priporoča se, da začnete zdravljenje slabosti s Cerenia raztopino za injiciranje.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
BESEDILO “ SAMO ZA ŽIVALI ”
For animal treatment only - to be supplied only on veterinary prescription
Samo za živali - oskrba le na podlagi veterinarskega recepta.