FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using Posaconazole AHCL, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij o uporabi zdravila Posaconazole AHCL glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Posaconazole AHCL have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Posaconazole AHCL upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: As for every medicine, the company provided studies on the quality of Posaconazole AHCL.
Slovenian: Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Posaconazole AHCL.
English: What measures are being taken to ensure the safe and effective use of Posaconazole AHCL?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Posaconazole AHCL?
English: For the treatment of fungal infections, with the exception of thrush, Posaconazole AHCL is taken at a dose of 400 mg (10 ml) twice a day, or 200 mg (5 ml) four times a day in patients who are not eating.
Slovenian: Pri zdravljenju glivnih okužb, razen soora, se zdravilo Posaconazole AHCL jemlje v odmerku 400 mg (10 ml) dvakrat na dan ali 200 mg (5 ml) štirikrat na dan pri bolnikih, ki ne jedo.
English: Posaconazole AHCL (posaconazole)
Slovenian: Posaconazole AHCL (posakonazol)
English: An overview of Posaconazole AHCL and why it is authorised in the EU
Slovenian: Pregled zdravila Posaconazole AHCL in zakaj je odobreno v EU
English: • invasive aspergillosis (fungal infection caused by Aspergillus),
Slovenian: • invazivne aspergiloze (glivne okužbe, ki jo povzročajo glive iz rodu Aspergillus),
English: This means that Posaconazole AHCL contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Noxafil.
Slovenian: To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Noxafil.
English: Posaconazole AHCL can only be obtained with a prescription and treatment should be started by a doctor who has experience in managing fungal infections or in treating patients at high risk of invasive fungal infections.
Slovenian: Predpisovanje in izdaja zdravila Posaconazole AHCL je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem glivnih okužb ali bolnikov z visokim tveganjem za invazivne glivne okužbe.
English: Why is Posaconazole AHCL authorised in the EU?
Slovenian: Zakaj je zdravilo Posaconazole AHCL odobreno v EU?
English: The active substance in Posaconazole AHCL, posaconazole, is an antifungal medicine that belongs to the triazole group.
Slovenian: Učinkovina zdravila Posaconazole AHCL, posakonazol, je protiglivično zdravilo iz skupine triazolov.
English: As for all medicines, data on the use of Posaconazole AHCL are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Posaconazole AHCL stalno spremljajo.
English: What are the benefits and risks of Posaconazole AHCL?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Posaconazole AHCL?
English: Other information about Posaconazole AHCL
Slovenian: Druge informacije o zdravilu Posaconazole AHCL
English: • fusariosis (fungal infection caused by Fusarium),
Slovenian: • fuzarioze (glivne okužbe, ki jo povzročajo glive iz rodu Fusarium),
English: Posaconazole AHCL contains the active substance posaconazole and is a ‘generic medicine'.
Slovenian: Zdravilo Posaconazole AHCL vsebuje učinkovino posakonazol in je „generično zdravilo“.
English: What is Posaconazole AHCL and what is it used for?
Slovenian: Kaj je zdravilo Posaconazole AHCL in za kaj se uporablja?
English: • coccidioidomycosis (fungal infection of the lungs caused by breathing in spores).
Slovenian: • kokcidioidomikoze (glivne okužbe pljuč, ki jo povzroča vdihavanje spor).
English: Posaconazole AHCL is also used as a first-line treatment for ‘thrush', a fungal infection of the mouth and throat due to Candida.
Slovenian: Zdravilo Posaconazole AHCL se uporablja tudi kot zdravljenje prve izbire pri glivni okužbi ust in grla, sooru, z glivo Candido.
English: Therefore, the Agency's view was that, as for Noxafil, the benefit of Posaconazole AHCL outweighs the identified risk and it can be authorised for use in the EU.
Slovenian: Zato je menila, da koristi zdravila Posaconazole AHCL enako kot pri zdravilu Noxafil odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: The list of fungi posaconazole is active against can be found in the summary of product characteristics.
Slovenian: Seznam glivic, proti katerim posakonazol učinkuje, je na voljo v povzetku glavnih značilnosti zdravila.
English: For thrush, Posaconazole AHCL is taken as 200 mg (5 ml) on the first day followed by 100 mg (2.5 ml) once a day for the following 13 days.
Slovenian: Pri zdravljenju soora se zdravilo Posaconazole AHCL prvi dan vzame v odmerku 200 mg (5 ml), nato pa se 13 dni jemlje v odmerku 100 mg (2,5 ml) enkrat na dan. Za preprečevanje invazivnih glivnih okužb se zdravilo Posaconazole AHCL jemlje v odmerku 200 mg (5 ml) trikrat na dan. Trajanje zdravljenja je odvisno od bolnikovega stanja.
English: How has Posaconazole AHCL been studied?
Slovenian: Kako je bilo zdravilo Posaconazole AHCL raziskano?
English: How is Posaconazole AHCL used?
Slovenian: Kako se zdravilo Posaconazole AHCL uporablja?
English: How does Posaconazole AHCL work?
Slovenian: Kako zdravilo Posaconazole AHCL deluje?
English: Horse.
Slovenian: Konj
English: Treatment can be continued for a maximum of 14 consecutive days.
Slovenian: Zdravljenje lahko traja največ 14 zaporednih dni.
English: In case of doubt, it is advisable to test the urine.
Slovenian: V primeru dvoma je priporočljiva preiskava urina.
English: Approximately 70% of an orally administered dose is excreted in the urine.
Slovenian: Približno 70 % peroralno vnesenega odmerka se izloči z urinom.
English: Bioavailability after oral administration is 80-90%, but is reduced significantly if medication is administered with food.
Slovenian: Njegova biološka uporabnost po peroralnem dajanju je 80 do 90 % vendar pa je znatno manjša, če zdravilo dajemo ob obroku hrane.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Za pomožne snovi, navedene v poglavju 6.1 SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
English: The active substance in Quadrisol is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: Zdravilna učinkovina v Quadrisol je dovoljena učinkovina, kot je navedena v tabeli 1(dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010:
English: Overdosing may lead to death of treated animals.
Slovenian: Preveliki odmerki lahko povzročijo smrt zdravljenih živali.
English: INDICATION(S) Reduction of inflammation and relief of pain.
Slovenian: INDIKACIJA(E) Zmanjšanje vnetja in bolečine.
English: Both enantiomers contribute to therapeutic actions of the compound.
Slovenian: Oba enantiomera prispevata k terapevtskim učinkom racemata.
English: The terminal half-life following oral administration is 350-500 minutes and no accumulation occurs following repeated oral dosing.
Slovenian: Končna razpolovna doba je po peroralnem dajanju 350 do 500 minut, po večkratnem peroralnem dajanju ne prihaja do kopičenja.
English: Symptoms are reversible.
Slovenian: Simptomi so reverzibilni.
English: The most abundant metabolite is a monohydroxylated derivative.
Slovenian: Presnovek, ki nastaja v največji količini, je monohidroksilirani derivat.
English: Both enantiomers are equipotent PGF2α antagonists.
Slovenian: Oba enantiomera sta enako močna antagonista PGF2 α
English: Marker residue
Slovenian: Marker zaostanek
English: Steady state is reached quickly following onset of treatment.
Slovenian: Ravnovesno stanje doseže hitro po začetku zdravljenja.
English: Do not use in foals under the age of 6 months.
Slovenian: Ne uporabite pri žrebičkih, mlajših od 6 mesecev.
English: Meat and offal: 12 days
Slovenian: Meso in organi: 12 dni
English: Other NSAIDs, diuretics and substances with high protein binding may compete for binding and lead to toxic effects.
Slovenian: Druga nesteroidna protivnetna zdravila (NSAID), diuretiki in snovi z veliko vezavo na beljakovine lahko tekmujejo za vezna mesta, zaradi česar lahko pride do toksičnih učinkov.
English: 130 mg For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: A 30 ml adjustable multidose syringe consisting of high density polyethylene (white) and low density polyethylene (white and natural).
Slovenian: Nastavljiva večodmerna brizga po 30 ml, izdelana iz polietilena visoke gostote (bele barve) in polietilena nizke gostote (bele in naravne barve).
English: Reduction of inflammation and relief of pain associated with musculo-skeletal disorders and soft tissue lesions (traumatic injuries and surgical trauma).
Slovenian: Zmanjšanje vnetja in bolečine pri mišično-skeletnih obolenjih in poškodbah mehkega tkiva (travmatskih poškodbah in kirurških travmah).
English: Horses intended for racing and competition should be treated according to local requirements.
Slovenian: Dirkalne in tekmovalne konje je treba zdraviti v skladu z nacionalnimi zahtevami.
English: Twice daily administration.
Slovenian: Zdravilo dajemo 2-krat na dan.
English: BATCH NUMBER Lot: {number}
Slovenian: ŠTEVILKA SERIJE Lot {številka}
English: OTHER INFORMATION For animal treatment only.
Slovenian: DRUGE INFORMACIJE Samo za živali.
English: Date of last renewal: 13 November 2007
Slovenian: Datum pridobitve dovoljenja za promet: 4 december 1997 Datum podaljšanja dovoljenja za promet: 13 november 2007
English: The (+) enantiomer is more potent in inhibiting prostaglandin synthesis.
Slovenian: (+) enantiomer močneje zavira sintezo prostaglandinov.
English: In case of prophylactic treatment, a maximum duration of treatment of 7 consecutive days is sufficient.
Slovenian: Pri profilaktičnem zdravljenju zadošča zdravljenje 7 zaporednih dni.
English: The gel is administered orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of gel on the back of the tongue.
Slovenian: Gel dajemo peroralno, tako da konico brizge potisnemo skozi medzobni prostor in potrebno količino gela iztisnemo na zadnjo stran jezika.
English: Do not use in animals suffering from alimentary tract disorders, impaired heart, liver and kidney function.
Slovenian: Ne uporabite pri živalih, ki imajo obolenja prebavil ali srčne, jetrne ali ledvične okvare.
English: Horses with oral lesions should be assessed clinically and the attending veterinarian should take a decision as to whether treatment should be continued.
Slovenian: Pri konjih s poškodbami v ustni votlini je treba stanje klinično oceniti, lečeči veterinar pa mora odločiti o nadaljevanju zdravljenja.
English: Avoid the use in any dehydrated, hypovolaemic or hypotensive animals, as there may be potential risk of increased renal toxicity.
Slovenian: Uporabi zdravila se je treba izogibati pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih, ker se pri njih lahko poveča nevarnost toksičnih učinkov na ledvice.
English: EU/2/97/005/005
Slovenian: EU/2/97/005/001 EU/2/97/005/005
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Slovenian: PROIZVAJALČEVA ŠTEVILKA SERIJE Lot {številka}
English: In cases of anticipated surgical trauma, Quadrisol can be given prophylactically at least 3 hours prior to elective surgery.
Slovenian: Če je kirurška travma pričakovana, lahko dajemo Quadrisol profilaktično najmanj 3 ure pred kirurškim posegom.
English: Do not use in the case of hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali na katerokoli pomožno snov.
English: Propylene glycol:
Slovenian: Propilenglikol:
English: Vedaprofen is highly bound to plasma proteins and extensively metabolised.
Slovenian: Vedaprofen se obsežno veže na beljakovine v plazmi in v veliki količini presnavlja.
English: Not authorised for use in lactating animals producing milk for human consumption.
Slovenian: Ni dovoljena uporaba pri živalih, katerih mleko je namenjeno prehrani ljudi.
English: An initial dose of 2 mg/kg (2.0 ml/100 kg) is followed by a maintenance dose of 1 mg/kg (1.0 ml/100 kg) given every 12 hours.
Slovenian: Začetni odmerek je 2 mg/kg (2,0 ml/100 kg), nato dajemo vzdrževalni odmerek po 1 mg/kg (1,0 ml/100 kg) vsakih 12 ur.
English: Purna Pharmaceuticals N.V. Rijksweg 17
Slovenian: Purna Pharmaceuticals N.V.
English: Vedaprofen is a non-steroidal anti-inflammatory drug (NSAID) belonging to the propionic acid derivate group.
Slovenian: Vedaprofen je nesteroidno protivnetno zdravilo (NSAID) iz skupine derivatov aril-propionske kisline.
English: All metabolites of vedaprofen were shown to be less active than the parent compound as determined by a thromboxane B2 formation inhibition assay.
Slovenian: Vsi presnovki vedaprofena so manj učinkoviti kot matična spojina, kar je pokazal preizkus zaviranja nastajanja tromboksana B2.
English: None known.
Slovenian: Ni smiselno.
English: Appropriate precautions must be taken for such horses to ensure compliance with competition regulations.
Slovenian: Pri teh konjih je treba paziti, da je zdravljenje v skladu s tekmovalnimi predpisi.
English: Vedaprofen inhibits the prostaglandin synthesis enzyme system (cyclo-oxygenase enzyme) and thus possesses anti-inflammatory, antipyretic and analgesic properties.
Slovenian: Vedaprofen zavira encim sinteze prostaglandinov (ciklooksigenazo) in deluje protivnetno, antipiretično in analgetično.
English: Vedaprofen is rapidly absorbed following oral administration.
Slovenian: Vedaprofen se po peroralnem dajanju hitro absorbira.
English: Quadrisol must not be given with other NSAIDs or glucocorticosteroids.
Slovenian: Quadrisola ne smete dajati hkrati z drugimi nesteroidnimi protivnetnimi zdravili (NSAID) ali glukokortikosteroidi.
English: Quadrisol 100 mg/ml can be used during pregnancy.
Slovenian: Quadrisol 100 mg/ml se sme dajati v obdobju brejosti.
English: SPECIAL WARNINGS, IF NECESSARY If side effects occur, treatment should be discontinued.
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Če se pojavijo stranski učinki, moramo zdravljenje prekiniti.
English: EXPIRY DATE EXP: {Month/year}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/005/001 (1 x 30 ml)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/97/005/001 (1 x 30 ml)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Quadrisol oral gel contains:
Slovenian: 1 ml peroralnega gela Quadrisol vsebuje:
English: Shelf-life after first opening of the product: 2 months.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 2 meseca
English: It is advisable to administer the product before feeding.
Slovenian: Zdravilo je priporočljivo dajati pred krmljenjem.
English: Side effects are reversible.
Slovenian: Neželeni učinki so reverzibilni.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
English: Manufacturers responsible for batch release:
Slovenian: Proizvajalec odgovoren za sproščanje serij:
English: Studies in the horse have demonstrated potent inhibition of prostaglandin E2 (PG E2) synthesis in exudate and thromboxane B2 synthesis in serum and exudate.
Slovenian: Raziskave pri konjih so pokazale, da močno zavira sintezo prostaglandina E2 (Pg E2) v eksudatu in sintezo tromboksana B2 v serumu in eksudatu.Vsebuje nesimetrični ogljikov atom in je zato racemna zmes (+) enantiomera in (-) enantiomera.
English: SPECIAL STORAGE CONDITIONS No special precautions for storage.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Za shranjevanje ni posebnih navodil.
English: The advised dosage is an initial dose of 2 mg/kg (2.0 ml/100 kg) followed by a maintenance dose of 1 mg/kg (1.0 ml/100 kg) given every 12 hours.
Slovenian: Quadrisol dajemo 2-krat na dan. Priporočeno odmerjanje je začetni odmerek po 2 mg/kg (2,0 ml/100 kg), nato zdravljenje nadaljujemo z vzdrževalnim odmerkom po 1 mg/kg (1,0 ml/100 kg) vsakih 12 ur.
English: Horses should be monitored for oral lesions during treatment.
Slovenian: Konje je treba med zdravljenjem opazovati, da bi odkrili morebitne poškodbe v ustni votlini.
English: For full contra-indications, see package leaflet.
Slovenian: Podrobni podatki o kontraindikacijah so v priloženem navodilu.
English: Typical undesirable effects associated with NSAID use, such as lesions in the alimentary tract, soft faeces, urticaria and lethargy.
Slovenian: Zasledili so značilne neželene učinke nesteroidnih protivnetnih zdravil (NSAID), kot so poškodbe v prebavilih, mehko blato, urtikarija in letargija.
English: The syringe is fitted with variable dose capability, adjustable in steps of 0.5 ml and graduated to 1 ml.
Slovenian: Brizga ima oznake po 1 ml in je opremljena z nastavkom za različne odmerke, ki jih lahko prilagajamo v stopnjah po 0,5 ml. Na voljo so zloženke z eno brizgo ali tremi brizgami.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: 2 meseca Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.
English: The safety of the veterinary medicinal product has not been established during lactation
Slovenian: Varnost zdravila ni dokazana med laktacijo.
English: Adjustable dose syringe, containing 30 ml gel 3 adjustable dose syringes, each containing 30 ml gel
Slovenian: 3 brizge z nastavljivo velikostjo odmerka s po 30 ml gela
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Pojavijo se lahko poškodbe in krvavitve v prebavilih, driska, urtikarija, letargija in zmanjšan tek.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: non-steroidal anti-inflammatory drug ATCvet code: QM01AE90
Slovenian: Oznaka ATCvet: QM01AE90
English: If symptoms occur, treatment should be discontinued.
Slovenian: Če se ti simptomi pojavijo, je treba zdravljenje prekiniti.
English: Typical non-steroidal anti-inflammatory drugs (NSAIDs) side effects such as lesions and bleedings in the alimentary tract, diarrhoea, urticaria, lethargy, inappetence.
Slovenian: Zasledili so značilne neželene učinke nesteroidnih protivnetnih zdravil (NSAID), kot so poškodbe in krvavitve v prebavilih, driska, urtikarija, letargija in zmanjšan tek.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Slovenian: BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM'' Zdravilo shranjujte nedosegljivo otrokom.
English: Bodyweight and dosage must be accurately determined to avoid overdosing.
Slovenian: Da bi se izognili prevelikemu odmerjanje, je treba natančno določiti telesno maso in odmerjanje.
English: If oral lesions persist, treatment should be discontinued.
Slovenian: Če trajajo poškodbe v ustni votlini dlje časa, je treba zdravljenje prekiniti.
English: ROUTE(S) OF ADMINISTRATION For oral use.
Slovenian: POT(I) UPORABE ZDRAVILA Za peroralno uporabo.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev )zdravila, odgovornega (odgovornih) za sprostitev serije
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Vedaprofen:
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGIH SESTAVIN
English: Do not use in lactating mares.
Slovenian: Ne uporabite pri kobilah v obdobju laktacije.
English: Before administration, the syringe should be adjusted to the calculated dosage by setting the ring on the plunger.
Slovenian: Pred dajanjem s pomikom objemke na batu brizgo nastavimo na izračunani odmerek.
English: Bodyweight and dosage rate must be accurately determined to avoid overdosing.
Slovenian: Da bi se izognili prevelikemu odmerjanju, je treba natančno določiti telesno maso.
English: In case of accidental ingestion by a person, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: PACKAGE LEAFLET: Quadrisol 100 mg/ml oral gel for horses
Slovenian: Quadrisol 100 mg/ml, peroralni gel za konje
English: Target tissues Other provisions vedaprofen vedaprofen Equidae 1000 µg/kg 100 µg/kg
Slovenian: Ciljna tkiva Druge določbe vedaprofen vedaprofen kopitarji
English: Withdrawal period(s):
Slovenian: Učinkovina(e):
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Quadrisol 100 mg/ml oral gel for horses
Slovenian: NAVODILO ZA UPORABO Quadrisol 100 mg/ml, peroralni gel za konje
English: Shelf-life after first opening the immediate packaging: 2 months.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 2 meseca 6.4 Posebna navodila za shranjevanje
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 100 mg/ml oral gel for horses
Slovenian: PODATKI NA ZUNANJI OVOJNINI 100 mg/ml, peroralni gel za konje
English: PHARMACEUTICAL FORM Oral gel
Slovenian: FARMACEVTSKA OBLIKA
English: CLINICAL PARTICULARS
Slovenian: Klorovodikova kislina
English: TARGET SPECIES Horse.
Slovenian: CILJNE ŽIVALSKE VRSTE
English: Water (minimum purified grade), Propylene glycol, Hydroxyethylcellulose, Potassium hydroxide (E525), Hydrochloric acid, Chocolate flavour.
Slovenian: Kalijev hidroksid (E525)
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
English: To be supplied only on veterinary prescription.
Slovenian: {nalepka na injektorju} IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Quadrisol is intended for twice daily administration.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
English: WITHDRAWAL PERIOD(S) Withdrawal period(s):
Slovenian: Najvišje dovoljene količine zaostankov (MRL)
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Vedaprofen:
Slovenian: Pomožna (pomožne) snov(i):
English: Kidney Liver Muscle Fat
Slovenian: Zoetis Belgium SA Rue Laid Burniat 1
English: Each injection is given into a vein slowly, but in less than two minutes.
Slovenian: Injekciji se dajeta v veno počasi, a v manj kot dveh minutah.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rapilysin on 9 November 1996.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Rapilysin, veljavno po vsej Evropski uniji, izdala 9. novembra 1996.