natgillin/translations-raw huggingface dataset:
The Marketing Authorisation Holders of adrenaline auto-injectors shall submit to the National Competent Authorities a Risk Management Plan containing key elements as described in the CHMP assessment report (including educational materials). 
Imetniki dovoljenj za promet z zdravilom za samoinjektorje adrenalina morajo nacionalnim pristojnim organom predložiti načrt obvladovanja tveganja, ki vsebuje ključne elemente, opisane v poročilu odbora CHMP o oceni (vključno z izobraževalnimi gradivi).
Each Marketing Authorisation Holder of adrenaline auto-injectors shall perform a PK/PD study to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via their adrenaline auto-injector device. 
Vsak imetnik dovoljenja za promet z zdravilom za samoinjektorje adrenalina bo izvedel FK-/FD-študijo, s katero bi lahko pojasnili vpliv različnih dejvnikov na porazdelitev, izpostavljenost in aktivnost adrenalina, kadar se uporablja s samoinjektorjem adrenalina.
National Competent Authorities of Member States or Reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAHs: 
Pristojni nacionalni organi držav članic ali referenčnih držav članic bodo zagotovili, kadar je to primerno, da imetniki dovoljenj za promet z zdravilom izpolnjujejo naslednje pogoje:
Austria and Hungary 
Avstrija in Madžarska
As above 
Kot zgoraj
Belgium, Czech Republic, Denmark, Spain, Finland, Italy, Luxembourg, The Netherlands, Norway, Poland and Slovakia 
Belgija, Češka republika, Danska, Španija, Finska, Italija, Luksemburg, Nizozemska, Norveška, Poljska in Slovaška
The responses were submitted to the EMEA on 12 September 2006. 
Odgovori so bili predloženi EMEA 12. septembra
Not known. 
Niso znane.
In these cases take immediate contact to a doctor. 
V takšnih primerih se takoj posvetujte z zdravnikom.
The variation between individual cows was 1-3 hours. 
Razlika med posameznimi kravami je znašala 1 do 3 ure.
For generic applications bioequivalence must be demonstrated. 
Za splošno uporabo je treba dokazati bioekvivalenco.
The bioavailability after per-oral dosing is about 76 %. 
Biološka razpoložljivost po peroralnem odmerjanju je približno 76 %.
The reason for this was that the national competent authorities of Belgium and Norway considered that this medicinal product could present a potential serious risk to animal health on the ground that the efficacy has not been sufficiently substantiated in the dossier. 
Razlog za to je bilo mnenje nacionalnih pristojnih organov Belgije in Norveške, da lahko zdravilo predstavlja potencialno resno tveganje za zdravje živali, saj v dosjeju učinkovitost zdravila ni bila zadostno utemeljena.
No such studies have been conducted with cattle. 
Podobnih študij na govedu niso opravili.
Do not use in animals which have completely lost their appetite because this could lead to insufficient absorption of ketoprofen. 
Ne uporabite pri živalih, ki so v celoti izgubile apetit, ker to lahko privede do nezadostne absorbcije ketoprofena.
This is also the indication applied for at the start of the mutual recognition procedure (MRP). 
Ta indikacija je tudi v vlogi za začetek postopka medsebojnega priznavanja (MRP).
There is no specific antidote. 
Specifičnih protistrupov ni na voljo.
Rifen 2.4g As above 
Rifen 2,4 g Kot zgoraj
However, given that the pharmacokinetic data allowed to optimise the dose (keeping overall exposure comparable between the two products), it is concluded that a bridge exists that allows wellestablished use to apply to Dolovet. 
Vendar se glede na to, da so farmakokinetični podatki omogočili optimizacijo odmerka (z ohranjanjem primerljivosti celokupne izpostavljenosti med obema zdraviloma), lahko zaključi, da obstaja povezava, ki omogoča dobro utemeljeno uporabo zdravila Dolovet.
Although not all effects of ketoprofen are covered by thromboxane activity (ketoprofen also has lipooxygenase activity), thromboxane activity is a sensitive parameter, not only for evaluating inflammation in this experimental model, but also for allowing extrapolation to the field condition up to a certain point. 
Čeprav vseh učinkov ketoprofena ne pokriva tromboksanska aktivnost (ketoprofen ima tudi lipooksigenazno aktivnost), je tromboksanska aktivnost občutljiv parameter ne samo za oceno vnetja v tem eksperimentalnem modelu temveč tudi za ekstrapolacijo terenskih pogojev do določene točke.
In cases of overdose symptomatic therapy should be given. 
V primerih prevelikega odmerjanja uvedemo simptomatsko zdravljenje.
If one accepts that a bridge exists, then the clinical indications that exist for Ketofen, as evidence in the literature, should apply in large part to Dolovet. 
Če sprejmemo, da obstaja povezava, potem morajo obstoječe klinične indikacije za Ketofen, dokazane v literaturi, v veliki meri veljati tudi za zdravilo Dolovet.
The experimental design of the study mimics an acute toxic mastitis. 
Eksperimentalni načrt raziskave posnema akutni toksični mastitis.
4..6 Adverse reactions (frequency and seriousness) 
Neželeni učinki (pogostost in resnost)
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 3.8.2005 (revised2 10.11.2006) 
3.8.2005 (datum zadnje revizije: 10.11.2006)
However, a dose confirmation study, submitted with the response, is considered pivotal for the assessment of the efficacy: “Dose confirmation of oral ketoprofen in endotoxin-induced mastitis in cows, Study 06-131-LC, August 7th, 2006”. 
Vendar vlagatelj šteje raziskavo določitve odmerka, ki jo je predložil z odgovorom, kot ključno za oceno učinkovitosti: „Določitev peroralnega odmerka ketoprofena pri mastitisu pri kravah, sproženem z endotoksinom, Raziskava 06-131-LC, 7. avgust 2006“.
For example, in generic applications, a preclinical bridge is made that allows extrapolation to the field situation. 
Npr. za splošno uporabo se vzpostavi predklinična povezava, ki omogoča ekstrapolacijo na terensko situacijo.
Even though equivalence has not been formally shown, the two products perform similarly when compared to placebo in regards to a number of critical parameters, both clinical and otherwise (thromboxane B2 levels in plasma). 
Čeprav enakovrednost ni bila formalno dokazana, imata obe zdravili podobno učinkovitost v primerjavi s placebom glede na številne kritične parametre, tako klinične kot tudi drugačne parametre (ravni tromboksana B2 v plazmi).
The elimination half life after per oral administration was about 4,5 hours. 
Razpolovni čas izločanja po peroralnem vnosu je znašal približno 4,5 ure.
Considering then the data provided and the well-established use of ketoprofen, CVMP is of the opinion that the following claim can be substantiated: 
Na osnovi predloženih podatkov in dobro utemeljene uporabe ketoprofena CVMP meni, da obstajajo dokazi za naslednji zahtevek:
Reducing of pyrexia or fever and alleviation of inflammation are considered important clinical claims that should be retained as they have been demonstrated clearly enough. 
Zniževanje pireksije oz. zvišane telesne temperature in lajšanje vnetja se štejeta za pomembna klinična zahtevka in ju je treba ohraniti v indikacijah, saj sta bila zadostno dokazana.
General and local clinical signs, milk production, somatic cell counts, thromboxane B2 levels in milk and in plasma, and serum levels of zinc, calcium, magnesium, and copper were studied. 
Preučili so splošne in lokalne klinične znake, nastajanje mleka, število somatskih celic, ravni tromboksana B2 v mleku in plazmi ter serumske ravni cinka, kalcija, magnezija ter bakra.
To restrict the indications of Dolovet to only those that were tested (endotoxemic mastitis control) would be inappropriate. 
Omejevanje indikacij zdravila Dolovet izključno na indikacije, ki so bile preizkušene (zdravljenje endotoksemijskega mastitisa), bi bilo neprimerno.
A trend exists for udder size of the inoculated quarter, pain as reported on a visual analog scale (VAS) after palpation, and poorer milk aspect (milk production was equally affected in all groups). 
Pokazal se je trend za velikost inokulirane četrti vimena, bolečino, določeno z vizualno analogno lestvico (VAS) po palpaciji in slabše lastnosti mleka (nastajanje mleka je bilo v vseh skupinah prizadeto enako).
In Finland the product has been authorised for the indication: “The treatment of fever and inflammation in cattle”. 
Na Finskem je bilo zdravilo odobreno za indikacijo: „Zdravljenje zvišane telesne temperature in vnetja pri govedu“.
In his response the Marketing Authorisation Holder (MAH)did not develop any further the preclinical argument already presented during the mutual recognition procedure. 
V odgovoru vlagatelj ni razširil predkliničnih argumentov, ki so že bili predstavljeni v postopku medsebojnega priznavanja.
Vetcare Ltd. P.O.Box 99 24101 Salo Finland 
Vetcare Ltd. P.O.Box 99 24101 Salo Finska
The Reference Member State for the Mutual Recognition Procedure regarding Dolovet vet 2.4g oral powder, Finland, notified the EMEA on 2 March 2006 that the CMD(v) failed to reach an agreement regarding the product. 
Referenčna država članica v postopku medsebojnega priznavanja zdravila Dolovet vet 2,4 g peroralni prašek, Finska, je 2. marca 2006 obvestila EMEA, da v CMD(v) ni bilo doseženo soglasje o zdravilu.
Milk: zero days. 
Mleko: nič dni.
Thromboxane levels were measured in both milk and plasma. 
Izmerjene so bile ravni tromboksana v mleku in plazmi.
Do not use after the expiry date stated on the carton and bag. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in na vrečki po EXP:.
Both pain in the infected quarter and increased size are indicative of inflammation. 
Bolečina v okuženi četrti vimena in povečano vime kažeta na vnetje.
That a difference in udder size in the inoculated quarter is reported at all under these experimental conditions is noteworthy. 
Pomembno je izpostaviti, da je bila v vseh teh eksperimentalnih pogojih opažena razlika v velikosti inokulirane četrti vimena.
ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER 
DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, NAČINI UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET
Opposed to injectable ketoprofen the results for milk are not “as clear” for Dolovet as what they are for plasma. 
V nasprotju s ketoprofenom za injiciranje rezultati preiskav mleka za zdravilo Dolovet niso „tako jasni“ kot rezultati preiskav plazme.
Hands should be washed after the administration of the drug. 
Po dajanju zdravila si umijte roke.
One bag of 15g once daily for 1 - 3 days. 
Ena 15 g vrečka enkrat dnevno 1 - 3 dni.
Somatic cell counts were affected by the challenge, and few differences exist between the groups. 
Vnos endotoksina je vplival na število somatskih celic, med skupinami pa so bile razlike majhne.
The powder should be mixed with water e.g. in a bottle using ½ litres of water, shaked well and administered immediately per orally to an animal. 
Prašek je treba zmešati z vodo, npr. v steklenici s ½ litra vode, dobro pretresti in nemudoma dati živali peroralno.
- Maltodextrin - Carmellose sodium 
Maltodekstrin, natrijev karmelozat.
Following discussions in the CMD(v), the proposed indication was changed during the course of the MRP to: “For the treatment of painful disorders (lameness; abdominal pain) in individual animals”. 
Po razpravi znotraj skupine za usklajevanje medsebojnega priznavanja in decentraliziranih postopkov za veterinarska zdravila, CMD(v), je bila tekom postopka medsebojnega priznavanja predlagana indikacija spremenjena v: „Za zdravljenje bolečih obolenj (ohromelost; trebušne bolečine) pri posameznih živalih“.
To the target species: 
Za ciljno živalsko vrsto:
This corresponds to 4mg ketoprofen per kg body weight. 
To ustreza 4 mg ketoprofena na kg telesne mase.
Alleviation of inflammation and reduction of fever in individual animals. 
Lajšanje vnetja in zniževanje zvišane telesne temperature pri posameznih živalih.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Ketoprofen 2.4 g 
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) ketoprofen 2,4 g
The anti-inflammatory effect in tissues has been documented to continue even after the plasma concentration has decreased. 
Protivnetni učinek v tkivih se je dokumentirano ohranil tudi po znižanju vsebnosti ketoprofena v plazmi.
In cattle, after the recommended dose of 4 mg/kg of ketoprofen per os before feeding the concentrate, the highest concentration of ketoprofen in plasma (Cmax3,9 µg/ml) was achieved in about 2 hours. 
Po uporabi priporočenega odmerka 4 mg ketoprofena /kg (peroralni vnos pred krmljenjem koncentratov) je bila pri govedu najvišja vsebnost ketoprofena v plazmi (Cmax 3,9 µg/ml) dosežena v približno 2 urah.
36 healthy lactating cows were challenged in one hindquarter, infused with endotoxin Bacto E. coli 026:B6 lipopolysaccharide B (LPS). 
Pri 36 zdravih kravah v času laktacije so v eno zadnjo nogo infundirali endotoksin lipopolisaharid B (LPS) Bacto E. coli 026:B6.
Simultaneous use of loop-diuretics (for example furosemid) may decrease the effect of the diuretic. 
Istočasna uporaba diuretikov, ki delujejo na ledvično zanko (npr. furosemid), lahko zniža učinek diuretikov.
PHARMACEUTICAL FORM Oral powder. 
FARMACEVTSKA OBLIKA Peroralni prašek
An anti-oedemic effect is usually evaluated over several days, and an NSAID may be considered limited in its efficacy here. 
Učinek zmanjšanja otekline se ponavadi ocenjuje več dni in nesteroidna protivnetna zdravila (NSAID) imajo tukaj omejeno učinkovitost.
To be supplied only on veterinary prescription. 
Samo za živali - oskrba le na podlagi veterinarskega recepta.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE 
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
Strength Animal species 
CILJNE ŽIVALSKE VRSTE
Simultaneous use of glucocorticoids may add undesirable effects on GI-canal. 
Hkratna uporaba glukokortikoidov lahko privede do dodatnih neželenih učinkov v prebavilih.
If a person accidentally swallows a 2.4 g bag of Dolovet powder (= 2400 mg ketoprofen), it may cause a serious intoxication. 
Nenamerno zaužitje vrečke Dolovet vet praška (= 2400 mg ketoprofena) lahko povzroči resno zastrupitev.
The statistical report indicates that the number of animals used does not allow to establish equivalence (nor non-inferiority) between Dolovet containing ketoprofen administered orally at the dose of 4 mg/kg bodyweight, and Ketofen containing ketoprofen administered intramuscularly at the dose of 3 mg/kg. 
Statistično poročilo kaže, da je uporabljeno število živali premajhno za dokaz enakovrednosti (ali neinferiornosti) med zdravilom Dolovet s ketoprofenom peroralno v odmerku 4 mg/kg telesne mase in zdravilom Ketofen s ketoprofenom intramuskularno v odmerku 3 mg/kg.
Milk yield dropped for all groups and rose again after challenge, similarly for all groups. 
Donos mleka je upadel v vseh skupinah in se po vnosu endotoksina znova zvečal v vseh skupinah podobno.
Treatment was conducted two hours after challenge and the groups were Group A: Saline, Group B: 2 mg/kg ketoprofen orally, Group C: 4 mg/kg ketoprofen orally, and Group D: 3 mg/kg ketoprofen intramuscularly. 
Določili so naslednje skupine: skupina A: fiziološka raztopina, skupina B: 2 mg/kg ketoprofena peroralno, skupina C: 4 mg/kg ketoprofena peroralno in skupina D: 3 mg/kg ketoprofena intramuskularno.
The MAH was also requested to substantiate the bridging of pharmacokinetic studies and dose-confirmation studies data to prove efficacy. 
Imetnika dovoljenja za promet z zdravilom so zaprosili tudi, da utemelji povezovanje raziskav farmakokinetike in raziskav določitve odmerka za dokazovanje učinkovitosti.
MANUFACTURER'S BATCH NUMBER Batch 
IZDELOVALČEVA ŠTEVILKA SERIJE Serija:
Do not use for animals with gastrointestinal ulcers or severe renal insufficiency, coagulation disorders or severe hypovolemia. 
Ne uporabite pri živalih z razjedami (ulkusi) prebavil, hudo ledvično insuficienco, motnjami v strjevanju krvi ali hudo hipovolemijo.
The CVMP during its meeting of 14-16 March 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Dolovet vet 2.4g oral powder. 
CVMP se je na sestanku 14.-16. marca 2006 odločil, da za zdravilo Dolovet vet 2,4 g peroralni prašek začne napotitveni postopek iz člena 33(4) Direktive 2001/28/ES, kot je spremenjena.
After challenge and treatment, rectal temperature, ruminal contractions, and respiratory rate were significantly higher in the non-treated group than in the treated groups. 
Po vnosu endotoksina in zdravljenju so bili rektalna temperatura, število krčev želodcev in frekvenca dihanja statistično pomembno višji v nezdravljenih skupini kot v skupinah krav, ki so jih zdravili.
The blocking of cyclo-oxygenase enxyme inhibits the formation of the inflammation mediators PGE2 and PGI2. 
Blokada encima ciklooksigenaza zavira tvorbo prenašalcev vnetja PGE2 in PGI2.
Ketoprofen has been documented to stabilise lysosomal cell membranes. 
Dokazano je bilo, da ketoprofen stabilizira lizosomske membrane.
The inhibition of lipo-oxygenase enzyme reduces the synthesis of leucotriens. 
Inhibicija encima lipooksigenaza zmanjša tvorbo levkotrienov.
If you notice any other side effects, 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.
Applicant or Marketing Authorisation Holder 
Prosilec ali imetnik dovoljenja za promet z zdravilom
Ketoprofen has been shown to inhibit the intravenously injected E.coli endotoxin induced tromboxane B2 production in the bovine. 
Pri govedu se je pokazalo, da ketoprofen zavira tudi z intravensko injiciranim endotoksinom E. coli inducirano tvorbo tromboksana B2.
A 15 g aluminium-laminate sachet, which are further packed to a cardboard box. 
15 g vrečke iz aluminijske folije, pakirane v kartonsko škatlo, 3 x 15 g.
Ketroprofen inhibits the secretion of bradykinin, which is a chemical mediator of pain and inflammation. 
Ketoprofen zavira izločanje bradikinina, kemičnega mediatorja bolečine in vnetja.
The Marketing Authorisation Holder (MAH) was requested to substantiate the indication and posology as discussed during the recent MRP. 
Odbor je zaprosil imetnika dovoljenja za promet z zdravilom (MAH), da utemelji indikacijo in odmerjanje v skladu z razpravo, ki je potekala med nedavnim postopkom medsebojnega priznavanja.
People with known hypersensitivity to non steroidal anti-inflammatory drugs (NSAID) should avoid contact with the veterinary medicinal product. 
Osebe z znano preobčutljivostjo na nesteroidna protivnetna zdravila (NSPVZ) naj se izogibajo stiku z zdravilom.
4.2 Indications for use, specifying the target species Alleviation of inflammation and reduction of fever in individual animals 4.3 Contraindications 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Lajšanje vnetnih procesov in zniževanje povišane telesne temperature pri posameznih živalih.
Dolovet vet 2.4g oral powder is a powder presented in sachets of 15g, containing 2.4g ketoprofen each. 
Dolovet vet 2,4 g peroralni prašek je na voljo v vrečkah po 15 g, ki vsebujejo po 2,4 g ketoprofena.
Concentrations over 0,1 µg/ml in plasma were measured 24 hours after the administration of the drug. 
24 ur po uporabi zdravila so v plazmi izmerili vsebnost ketoprofena, višjo od 0,1 µg/ml.
Do not use for animals hypersensitive to ketoprofen or other non steroid anti-inflammatory (NSAID) drugs (like aspirin or flunixin). 
Ne uporabite v primeru preobčutljivosti na ketoprofen ali druga nesteroidna protivnetna zdravila (NSPVZ), na primer Aspirin ali Flunixin.
For well-established use dossiers the bridge can be constructed a bit more tentatively.) 
Za dosjeje za dobro utemeljeno uporabo pa je treba povezavo pripraviti nekoliko bolj eksperimentalno, kot se to sicer pričakuje za splošno uporabo.
Ketoprofen is a non steroid anti-inflammatory drug (NSAID) with anti-inflammatory, antipyretic and analgesic effect. 
Ketoprofen je nesteroidno protivnetno zdravilo (NSPVZ), ki deluje protivnetno, analgetično in antipiretično.
Do not use for animals hypersensitive to ketoprofen or other non steroid anti-inflammatory (NSAID) drugs. 
Ne uporabite v primeru preobčutljivosti na ketoprofen ali druga nesteroidna protivnetna zdravila (NSPVZ).
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 
BESEDILO “SAMO ZA ŽIVALI” Samo za živali (govedo).
NAME OF THE VETERINARY MEDICINAL PRODUCT Dolovet vet 2.4 g oral powder. 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dolovet vet 2,4 g peroralni prašek
SPECIAL WARNING(S) To the user: 
Za uporabnika:
2.4g ketoprofen per sachet of 15g powder 
2,4 g ketoprofena v vsaki vrečki s 15 g praška
The anti-inflammatory action of ketoprofen is based on the inhibition of cyclo-oxygenase and lipo-oxygenase enzymes. 
Protivnetno delovanje ketoprofena je posledica inhibicije encimov ciklooksigenaza in lipooksigenaza.
Ketoprofen may cause adverse reactions typical to non-steroidal anti-inflammatory drugs, such as diarrhoea which is caused by gastro-intestinal irritation and ulceration. 
Ketoprofen lahko povzroči neželene učinke, tipične za nesteroidna protivnetna zdravila, kot so diareja, ki nastopi zaradi draženja prebavil, in razjede (ulceracije).
Therefore the use of the product in cattle close to parturition should be avoided. 
Zaradi tega se je potrebno uporabi Dolovet vet praška pri govedu pred pričakovanim porodom izogibati.
The recommended dose and treatment time must not be exceeded. 
Posebni previdnostni ukrepi za uporabo pri živalih Ne presezite priporočenega odmerka in trajanja zdravljenja.
The induction of parturition in laboratory animals have been found to be delayed when ketoprofen was given just before parturition. 
Uporaba ketoprofena tik pred porodom je pri laboratorijskih živalih privedla do zakasnitve pričetka poroda.
3 x 15 g. 
VELIKOST PAKIRANJA 3 x 15 g
4.4 Special warnings for each target species 
Posebna opozorila za vsako ciljno živalsko vrsto Jih ni.
4.5 Special precautions for use Special precautions for use in animals 
4.5 Posebni previdnostni ukrepi
Other non steroidal anti-inflammatory drugs (NSAID) must not be used simultaneously with the product and within 24 hours after the last dose of Dolovet, because the substances may compete in binding with proteins thus leading to toxic effects. 
Istočasno in še 24 ur po zadnjem odmerku Dolovet vet praška ne smemo uporabiti drugih nesteroidnih protivnetnih zdravil (NSPVZ), ker učinkovine lahko tekmovale v vezavi na beljakovine, kar lahko privede do toksičnih učinkov.
The induction of parturition can be delayed when ketoprofen is given just before parturition. 
Uporaba ketoprofena tik pred porodom lahko privede do zakasnitve pričetka poroda.
No teratogenic or embryotoxic effects in laboratory animals with the recommended dose of ketoprofen has been recorded. 
Z laboratorijskimi študijami na živalih s priporočenim odmerkom ketoprofena niso bili dokazani teratogeni in fetotoksični učinki.
Frequency and route of administration 
NAČIN IN POT UPORABE
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
Ketoprofen 2.4 g For a full list of excipients, see section 6.1. 
Pomožne snovi: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
STATEMENT OF THE ACTIVE AND OTHER INGREDIENTS 1 sachet= 15 g powder contains of 2.4 g ketoprofen and exipients to 15 g. INDICATION(S) Alleviation of inflammation and reduction of fever in individual animals 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGEIH SESTAVIN 1 vrečka (15 g praška) vsebuje 2,4 g ketoprofena in pomožne snovi do 15g.
Batch 
Ketoprofen