FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, Pexion should not be used as a primary treatment for dogs with cluster seizures (group of seizures occurring close together) and status epilepticus (continual seizures).
Slovenian: Zato se zdravilo Pexion ne sme uporabljati kot primarno zdravljenje pri psih s serijskimi epileptičnimi napadi (več napadi v kratkih razmikih) in epileptičnim statusom (neprekinjenimi napadi).
English: During the evaluation phase of 12 weeks, 47% (30 out of 64) of Pexion-treated dogs were free from generalised seizures, whilst 58% (51 out of 88) of phenobarbital-treated dogs had no seizures.
Slovenian: Med 12-tedenskim ocenjevanjem se generalizirani epileptični napadi niso pojavili pri 47 % (30 od 64) psov, zdravljenih z zdravilom Pexion, in pri 58 % (51 od 88) psov, zdravljenih s fenobarbitalom.
English: For epilepsy, the most common side effects with Pexion (which may affect more than 1 in 10 dogs) are ataxia (inability to coordinate muscle movements), vomiting, polyphagia (excessive eating), and somnolence (sleepiness).
Slovenian: Najpogostejši neželeni učinki zdravila Pexion (ki lahko prizadenejo več kot 1 psa od 10) pri epilepsiji so ataksija (nezmožnost usklajenega premikanja mišic), bruhanje, polifagija (čezmerno uživanje hrane) in somnolenca (zaspanost).
English: Out of 104 Pexion-treated dogs, 64% showed a good or excellent effect compared to 25% of 122 dogs receiving dummy treatment (placebo) as reported by owners.
Slovenian: Kot so poročali lastniki psov, je bil učinek dober ali odličen pri 64 % od 104 psov, zdravljenih z zdravilom Pexion, ter pri 25 % od 122 psov, ki so prejemali zdravilo brez učinkovine (placebo).
English: For epilepsy, treatment with Pexion should be started at a dose of 10 mg per kg bodyweight twice a day.
Slovenian: Pri epilepsiji je treba zdravljenje z zdravilom Pexion uvesti v odmerku 10 mg na kg telesne mase dvakrat na dan.
English: Ingestion of this medicine may cause dizziness, lethargy and nausea.
Slovenian: Zaužitje tega zdravila lahko povzroči omotico, letargijo in siljenje na bruhanje.
English: How does Pexion work?
Slovenian: Kako zdravilo Pexion deluje?
English: For noise phobia, the most common side effects with Pexion (which may affect more than 1 in 10 dogs) are short-lived ataxia, increased appetite, and lethargy (lack of energy).
Slovenian: Najpogostejši neželeni učinki zdravila Pexion (ki lahko prizadenejo več kot 1 psa od 10) pri fobiji zaradi hrupa so kratkotrajna ataksija, povečan apetit in letargija (pomanjkanje energije).
English: Pexion-treated dogs also had reduced anxiety scores compared to the placebo group.
Slovenian: Psi, zdravljeni z zdravilom Pexion, so bili v primerjavi s skupino, ki je prejemala placebo, tudi manj tesnobni.
English: For noise phobia, treatment with Pexion is given at a dose of 30 mg per kg bodyweight twice a day, starting 2 days before an expected noise event and continuing through it.
Slovenian: Pri fobiji zaradi hrupa zdravljenje z zdravilom Pexion poteka z odmerkom 30 mg na kg telesne mase dvakrat na dan, pri čemer se začne dva dni pred pričakovanim hrupnim dogodkom in se nadaljuje ves čas dogodka.
English: In an EU field study looking at effects on noise phobia, the effectiveness of 3 days' treatment with Pexion, at a dose of 30 mg/kg bodyweight twice daily, was investigated during New Year's Eve fireworks in dogs diagnosed with noise phobia.
Slovenian: V terenski študiji, opravljeni v EU, v kateri so preučevali učinke na fobijo zaradi hrupa, so učinkovitost tridnevnega zdravljenja z zdravilom Pexion v odmerku 30 mg/kg telesne mase dvakrat dnevno preučevali pri psih z diagnozo fobije zaradi hrupa med novoletnimi ognjemeti.
English: Pexion contains the active substance imepitoin.
Slovenian: Zdravilo Pexion vsebuje učinkovino imepitoin.
English: How is Pexion used?
Slovenian: Kako se zdravilo Pexion uporablja?
English: In an EU field study looking at effects on epilepsy, Pexion at a dose of 10 to 30 mg/kg bodyweight twice daily reduced the average number of generalised seizures from 2.3 to 1.1 per month after 20 weeks of treatment.
Slovenian: V terenski študiji, opravljeni v EU, v kateri so preučevali učinke na epilepsijo, se je po 20 tednih zdravljenja z zdravilom Pexion z odmerkom 10-30 mg/kg telesne mase dvakrat dnevno povprečno število generaliziranih epileptičnih napadov znižalo z 2,3 na 1,1 napada na mesec.
English: The active substance in Pexion, imepitoin, is an anti-epileptic and anti-anxiety medicine.
Slovenian: Učinkovina v zdravilu Pexion, imepitoin, je zdravilo za preprečevanje epileptičnih napadov in zdravilo proti tesnobi.
English: In a second US field study looking at effects on epilepsy and involving 151 dogs, Pexion treatment for 12 weeks at a fixed dose of 30 mg/kg bodyweight twice daily resulted in 21% of dogs (21 out of 99) being free of generalised seizures compared to 8% of dogs (4 out of 52) given a dummy treatment.
Slovenian: V drugi terenski študiji, opravljeni v ZDA, v kateri so preučevali učinke na epilepsijo in ki je vključevala 151 psov, se med 12-tedenskim zdravljenjem epileptični napadi niso pojavili pri 21 % (21 od 99) psov, zdravljenih z zdravilom Pexion v fiksnem odmerku 30 mg/kg dvakrat na dan, in 8 % (4 od 52) psov, ki so prejemali zdravilo brez učinkovine.
English: This compared with a reduction of 2.4 seizures to 1.1 per month with phenobarbital (another anti-epileptic medicine).
Slovenian: Pri fenobarbitalu (drugem zdravilu za zdravljenje epileptičnih napadov) se je število napadov znižalo z 2,4 napada na 1,1 napada na mesec.
English: This means that it was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union.
Slovenian: To pomeni, da naj bi bilo podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je v Evropski uniji že odobreno.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 January 2017
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: It was to be available as a solution for injection under the skin.
Slovenian: Na voljo naj bi bilo v obliki raztopine za injiciranje pod kožo.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Slovenian: Vlogo so umaknili po tem, ko je odbor CHMP že ocenil začetno dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
English: The company had not yet responded to the questions at the time of the withdrawal.
Slovenian: Družba ob umiku vloge še ni odgovorila na zastavljena vprašanja.
English: In addition, two studies in patients receiving cancer medicines compared the safety and effectiveness of Zioxtenzo and Neulasta.
Slovenian: Poleg tega so v dveh študijah pri bolnikih, ki so prejemali zdravila za zdravljenje raka, primerjali varnost in učinkovitost zdravil Zioxtenzo in Neulasta.
English: Because filgrastim is pegylated, its removal from the body is slowed down, allowing the medicine to be given less often.
Slovenian: Ker je filgrastim pegiliran, se iz telesa odstranjuje počasneje, zato je treba zdravilo dajati manj pogosto.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Slovenian: Za več informacij o podobnih bioloških zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj.
English: Withdrawal of the marketing authorisation application for Zioxtenzo (pegfilgrastim) EMA/47326/2017
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Zioxtenzo (pegfilgrastim) EMA/47326/2017
English: On 18 January 2017, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zioxtenzo, intended for treating neutropenia in patients taking cancer treatments.
Slovenian: Družba Sandoz GmbH je 18. januarja 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Zioxtenzo, namenjenim zdravljenju nevtropenije pri bolnikih, ki jemljejo zdravila proti raku.
English: One concern was that study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo and Neulasta.
Slovenian: Eden izmed pomislekov je bil, da rezultati študije niso mogli dokazati, da so koncentracije pegfilgrastima v krvi enake po jemanju zdravil Zioxtenzo in Neulasta.
English: An inspection of the site will therefore be needed before the medicine can be approved.
Slovenian: Preden bo zdravilo lahko odobreno, bo potreben pregled proizvodnega mesta.
English: The other concern was the lack of a certificate of Good Manufacturing Practice (GMP) for the medicine's manufacturing site.
Slovenian: Drugi pomislek je bil odsotnost potrdila o dobri proizvodni praksi za proizvodno mesto, kjer zdravilo proizvajajo.
English: It encourages the bone marrow to produce more neutrophils and improves the patient's ability to fight off infections.
Slovenian: Filgrastim spodbuja kostni mozeg k proizvodnji večjega števila nevtrofilcev in izboljša bolnikovo sposobnost boja proti okužbam.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it would not be able to provide the additional data required by the CHMP within the timeframe allowed for the procedure.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da v časovnem okviru, določenem za postopek, ne bi mogla zagotoviti dodatnih podatkov, ki jih zahteva odbor CHMP.
English: Zioxtenzo was to be used in cancer patients to treat neutropenia (low levels of neutrophils, a type of white blood cell that helps fight infection).
Slovenian: Zdravilo Zioxtenzo naj bi se uporabljalo pri bolnikih z rakom za zdravljenje nevtropenije (nizke vrednosti nevtrofilcev, vrste belih krvnih celic, ki se pomagajo boriti proti okužbam).
English: Neutropenia is a side effect of certain cytotoxic (cell-killing) cancer treatments and can lead to development of serious infections.
Slovenian: Nevtropenija je neželeni učinek določenih citotoksičnih zdravil za zdravljenje raka (zdravil, ki uničujejo celice) in lahko vodi do razvoja resnih okužb.
English: Withdrawal of the marketing authorisation application for Zioxtenzo (pegfilgrastim)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Zioxtenzo (pegfilgrastim)
English: Zioxtenzo is a medicine that contains the active substance pegfilgrastim.
Slovenian: Zioxtenzo je zdravilo, ki vsebuje zdravilno učinkovino pegfilgrastim.
English: The company informed the CHMP that there is no impact of the withdrawal of Zioxtenzo on ongoing clinical trials and there are no compassionate use programmes for Zioxtenzo.
Slovenian: Družba je odbor CHMP obvestila, da umik zdravila Zioxtenzo nima vpliva na klinična preskušanja, ki trenutno potekajo, in da ne potekajo programi sočutne uporabe zdravila Zioxtenzo.
English: The active substance in Zioxtenzo, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Slovenian: Zdravilna učinkovina v zdravilu Zioxtenzo, pegfilgrastim, je sestavljena iz filgrastima, ki je bil pegiliran (nanj je bila pritrjena kemična snov, imenovana polietilenglikol).
English: The company presented results of studies designed to show that Zioxtenzo is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Slovenian: Družba je predstavila rezultate študij, ki naj bi pokazale, da je zdravilo Zioxtenzo po kemijski strukturi, čistosti, načinu delovanja in tem, kako ga telo presnavlja, zelo podobno referenčnemu zdravilu Neulasta.
English: The reference medicine for Zioxtenzo is Neulasta.
Slovenian: Referenčno zdravilo za zdravilo Zioxtenzo je zdravilo Neulasta.
English: At the time of the withdrawal, the company had not demonstrated that Zioxtenzo is highly similar to Neulasta and an inspection to confirm that it was being manufactured according to GMP standards had not yet taken place.
Slovenian: V času umika vloge družba ni dokazala, da je zdravilo Zioxtenzo zelo podobno zdravilu Neulasta, in pregled, ki bi potrdil, da je bilo zdravilo proizvedeno v skladu s standardi dobre proizvodne prakse, še ni bil opravljen.
English: Zioxtenzo was developed as a ‘biosimilar' medicine.
Slovenian: Zdravilo Zioxtenzo je bilo razvito kot „podobno biološko zdravilo“.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had two main concerns and was of the provisional opinion that Zioxtenzo could not have been approved as a biosimilar of Neulasta.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil dva glavna zadržka in je začasno menil, da zdravila Zioxtenzo ni mogoče odobriti kot biološko podobnega zdravilu Neulasta.
English: Zioxtenzo was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Slovenian: Zdravilo Zioxtenzo naj bi se uporabljalo za skrajšanje nevtropenije ter zmanjšanje pojavljanja febrilne nevtropenije (nevtropenije s povišano telesno temperaturo).
English: How does Zioxtenzo work?
Slovenian: Kako zdravilo Zioxtenzo deluje?
English: What was Zioxtenzo expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Zioxtenzo uporabljalo?
English: What is Zioxtenzo?
Slovenian: Kaj je zdravilo Zioxtenzo?
English: granulocyte-colony-stimulating factor (G-CSF).
Slovenian: Filgrastim je zelo podoben človeški beljakovini, imenovani granulocitne kolonije stimulirajoči faktor (G-CSF).
English: Avoid contact with the product.
Slovenian: Izogibajte se stiku z izdelkom.
English: 24 months.
Slovenian: 24 mesecev
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
English: The Ministerie van Landbouw, Natuurbeheer en Visserij confirmed that the manufacturing site was authorised under number 324-BVEAK for pharmaceutical products.
Slovenian: The Ministerie van Landbouw, Natuurbeheer en Visserij je potrdilo, da je kraj izdelave registriran pod številko 324-BVEAK za farmacevtske izdelke.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/024/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/00/024/001
English: Treat for 7 to 14 days.
Slovenian: Zdravite 7 do 14 dni.
English: PHARMACEUTICAL PARTICULARS 6.1 Incompatibilities None known.
Slovenian: FARMACEVTSKEI PODATKI 6.1 Glavne inkompatibilnosti Niso znane.
English: Lesions should be monitored closely for signs of infection.
Slovenian: Poškodbe je treba skrbno opazovati, da bi odkrili znake okužbe.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pruban 0.1 % cream for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Pruban 0,1 %, krema za pse
English: The treatment period should not exceed 14 days.
Slovenian: Zdravljenje ne sme trajati dlje kot 14 dni.
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
Slovenian: ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI
English: Do not use in puppies under 6 months of age.
Slovenian: Ne uporabite pri mladičih, mlajših od 6 mesecev.
English: For example, the total surface area treated of a dog weighing 5 kg should not exceed 50 cm2).
Slovenian: Na primer: skupna zdravljena površina pri psu, ki tehta 5 kg, ne sme prekoračiti 50 cm2).
English: SPECIAL WARNING(S), IF NECESSARY
Slovenian: POSEBNO(A) OPOZORIL(O)A, ČE JE/SO POTREBNO(A)
English: The expression of these effects depends on the mode of application and the dosage applied.
Slovenian: Izrazitost teh učinkov je odvisna od načina dajanja in velikosti odmerka.
English: Pharmacotherapeutic group: Glucocorticosteroid, ATCvet code: QD07AC90.
Slovenian: Farmakoterapevtska skupina: glukokortikosteroid, oznaka ATCvet: QD07AC90.
English: Do not use in animals suffering from Cushing's syndrome.
Slovenian: Ne uporabite pri živalih, ki imajo Cushingov sindrom.
English: The maximum total surface of lesions (treated in cm2) should not exceed 10 times the body weight (in kg).
Slovenian: Največja skupna površina zdravljenih poškodb (v cm2) ne sme biti večja kot 10-kratna telesna masa (v kg).
English: PHARMACEUTICAL FORM Cream
Slovenian: FARMACEVTSKA OBLIKA Krema
English: 4.2 Indications for use
Slovenian: 4.2 Indikacije za uporabo
English: 4.8 Interaction with other veterinary medicinal products and other forms of interaction Do not apply other topical preparations concomitantly to the same lesions.
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Na poškodbe sočasno ne nanašajte drugih pripravkov za lokalno uporabo.
English: Apply a 1 cm strip (0.2 g) of cream per 10 cm2 of lesion.
Slovenian: Nanesite 1 cm (0,2 g) kreme na 10 cm2 poškodbe.
English: PACKAGE SIZE Tube containing 15 g of cream
Slovenian: VELIKOST PAKIRANJA Tuba s 15 g kreme
English: Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Slovenian: Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z nacionalnimi zahtevami.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO ''SAMO ZA ŽIVALI'' TER POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
English: PHARMACEUTICAL FORM White to off-white cream
Slovenian: FARMACEVTSKA OBLIKA Bela do skoraj bela krema
English: The dog should be re-examined by the veterinarian if the lesion is not cured after 14 days of treatment.
Slovenian: Psa mora veterinar ponovno pregledati, če se poškodba po 14 dneh zdravljenja ne zaceli.
English: CONTRA-INDICATIONS
Slovenian: KONTRAINDIKACIJE
English: Do not store above 25 °C.
Slovenian: Ne shranjujte pri temperaturi nad 25 °C.
English: It is recommended that the animal be distracted for several minutes following treatment to prevent licking (oral absorption of the cream is not harmful to the dog, but removal of the cream by licking directly after treatment might decrease efficacy).
Slovenian: Žival je nekaj minut po nanašanju priporočljivo zamotiti, da se ne liže (peroralna absorpcija kreme psu ne škoduje, vendar pa se zmanjša njena učinkovitost, če kremo odstrani takoj po nanašanju).
English: 6.4 Nature and composition of immediate packaging Collapsible aluminium tube containing 15 g cream, sealed with aluminium and closed with a polyethylene screw cap, packed in cardboard boxes, one tube per box.
Slovenian: 1 zložljiva aluminijasta tuba s 15 g kreme, zatesnjena z aluminijasto zaporko in zaprta z navojno zaporko iz polietilena; zloženke z eno tubo.
English: Its mineralocorticoid and progestational activity is very low.
Slovenian: Njegov mineralokortikoidni in progestacijski učinek je zelo šibak.
English: The therapeutic use of these substances in humans has been recognised to induce local side effects such as skin thinning, skin weakness, delayed healing process and secondary infections.
Slovenian: Pri terapevtski uporabi teh snovi pri ljudeh so ugotovili, da imajo lokalne neželene učinke, kot so na primer tanjšanje kože, ohlapnost kože, upočasnjeno celjenje in sekundarne okužbe.
English: 4.7 Use during pregnancy and lactation
Slovenian: 4.7 Uporaba v obdobju brejosti in laktacije
English: Resocortol butyrate has local and systemic glucocorticoid effects.
Slovenian: Resokortol butirat ima lokalne in sistemske glukokortikoidne učinke.
English: 11 PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Navedba ni smiselna.
English: Do not use in dogs with extensive lesions.
Slovenian: Ne uporabite pri psih z obsežnimi poškodbami.
English: Since glucocorticosteroids can slow growth, use in young, growing animals should be well controlled and large lesions should not be treated.
Slovenian: Ker lahko glukokortikosteroidi upočasnijo rast, moramo njihovo uporabo pri mladih živalih, ki še rastejo, skrbno nadzorovati in jih ne uporabljati za zdravljenje velikih poškodb.
English: After oral administration in dogs few systemic effects were observed.
Slovenian: Po peroralnem dajanju so pri psih zasledili malo sistemskih učinkov.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THEMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
English: In case of diabetes mellitus, the potential systemic effects of the product may influence glycaemia.
Slovenian: Pri živalih s sladkorno boleznijo (diabetes mellitus) lahko morebitni sistemski učinki zdravila vplivajo na glikemijo.
English: 6.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from such medicinal products
Slovenian: 6.5 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo iz teh zdravil
English: 4.1 Target species
Slovenian: 4.1 Ciljna živalska vrsta
English: ANNEX III LABELLING AND PACKAGE INSERT
Slovenian: DODATEK III OZNAČEVANJE IN NAVODILO ZA UPORABO
English: Overdosing, i.e. application rate of more than twice a day, or extension of the duration of treatment, increases the risk of glucocorticoid systemic effects particularly when administered on extensive lesions.
Slovenian: pogostnejša uporaba kot 2-krat na dan ali podaljšanje zdravljenja, poveča nevarnost glukokortikoidnih sistemskih učinkov, zlasti kadar zdravilo uporabljamo na večjem predelu.
English: Shelf life after first opening of the tube: 8 weeks
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: 8 tednov
English: Resocortol butyrate is a corticosteroid which has a high intrinsic glucocorticoid activity.
Slovenian: Resokortol butirat je kortikosteroid z visoko intrinzično glukokortikoidno aktivnostjo.
English: EXPIRY DATE Month/Year
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI Mesec/leto
English: D. STATEMENT OF THE MRLs Not applicable.
Slovenian: D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Navedba ni smiselna.
English: To be supplied only on veterinary prescription.
Slovenian: Uporablja se le na osnovi veterinarskega recepta..
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 25 ºC.
English: 4.10 Overdose
Slovenian: 4.10 Preveliko odmerjanje
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only
Slovenian: BESEDILO ''SAMO ZA ŽIVALI'' Samo za živali
English: TARGET SPECIES
Slovenian: CILJNA ŽIVALSKA VRSTA
English: On rare occasions hyperaemia of the treated area has been observed.
Slovenian: Redko so na zdravljenem predelu zapazili hiperemijo.
English: For topical administration to the skin.
Slovenian: Za lokalno uporabo na koži.
English: This product belongs to the class of dermocorticoids.
Slovenian: Zdravilo sodi v skupino dermokortikoidov.
English: Not applicable.
Slovenian: Navedba ni smiselna.
English: Do not use in dogs with infected lesions of bacterial, viral, fungal or parasitic origin or with ulcerated lesions.
Slovenian: Ne uporabite pri psih z okužbami poškodb bakterijskega, virusnega, glivičnega ali parazitskega izvora, ali razjedami.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS IF ANY
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: After topical application on the skin, a local anti-inflammatory effect is seen, which is accompanied by a moderate and reversible adrenal suppression at higher doses.
Slovenian: Po nanašanju na kožo ima zdravilo lokalni protivnetni učinek, ki ga pri uporabi večjih odmerkov spremlja zmerna in reverzibilna supresija nadledvične žleze.
English: 4.6 Adverse reactions (frequency and seriousness) On rare occasions hyperaemia of the treated area has been observed.
Slovenian: 4.6 Neželeni učinki (pogostnost in resnost)
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Slovenian: ODMERJANJE ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN