FrancophonIA/ELRC3.0 huggingface dataset:
English: Not all pack sizes may be marketed.
Slovenian: Ni nujno, da so v prometu vsa navedena pakiranja
English: Body weight (kg) Number of chewable tablets by size mg/kg range
Slovenian: Število žvečljivih tablet glede na njihovo velikost mg/kg obseg
English: In case of accidental ingestion, seek medical advice immediately and show the package insert or the label to the physician.
Slovenian: V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
English: EXP {month/year} Half tablets should be returned to the original market container and may be stored for up to 7 days.
Slovenian: EXP {mesec/leto} Razpolovljene tablete vrnjene v originalno embalažo lahko hranite največ sedem dni.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a risk of increased renal toxicity.
Slovenian: Izogibajte se uporabi tega zdravila pri dehidriranih, hipovolemičnih in hipotenzivnih živalih, ker obstaja povečano tveganje za ledvice.
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) - mediated prostaglandin synthesis.
Slovenian: Firokoksib je nesteroidno protivnetno zdravilo (NSAID), selektivno zavira delovanje ciklooksigenaze-2 (COX-2) v sintezi prostaglandinov.
English: At dose rates equal or greater to 15 mg/kg/day (3 times the recommended dose) for six months, similar clinical signs were observed, albeit that the severity and frequency were less and duodenal ulcers were absent.
Slovenian: Podobna klinična znamenja so se pojavila po šestih mesecih pri odmerkih višjih od 15 mg/kg/dan, (trikratni priporočeni odmerek), čeprav so bila manj resna, manj pogosta in ni bilo razjed dvanajstnika.
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids.
Slovenian: Farmakoterapevtska skupina: Nesteroidna protivnetna in protirevmatična zdravila
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) - mediated prostaglandin synthesis.
Slovenian: Firokoksib je nesteroidno protivnetno zdravilo (NSAID), ki pripada skupini koksibov, in ki selektivno zavirajo delovanje ciklooksigenaze-2 (COX-2) v sintezi prostaglandinov.
English: For the relief of post-operative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery in dogs.
Slovenian: Za lajšanje post-operativne bolečine in blaženje vnetja, povezanih z operativnimi posegi na mehkih tkivih, ortopedskimi operativnimi posegi in zobni kirurgiji pri psih.
English: In dogs seven months of age at the start of treatment at dose rates greater than or equal to 25 mg/kg/day (5 times the recommended dose) for six months, gastrointestinal adverse effects, i.e. vomiting were observed.
Slovenian: Pri psih, ki so bili ob začetku raziskave stari 7 mesecev in so šest mesecev prejemali odmerke 25 mg/kg/dan ali višje (petkratni priporočeni odmerek), niso opazili stranskih učinkov v prebavilih t.j.
English: Do not use in pregnant or lactating bitches.
Slovenian: Ne uporabite pri psicah v obdobju brejosti in laktacije.
English: Laboratory studies in rabbits have shown evidence of maternotoxic and foetotoxic effects at dose rates approximating the recommended treatment dose for the dog.
Slovenian: Laboratorijske raziskave na kuncih z vnosom priporočenih odmerkov za pse so pokazale maternotoksične in fetotoksične učinke.
English: If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters occur, use of the product should be stopped and the advice of a veterinarian should be sought.
Slovenian: Če se pojavijo stranski učinki kot je bruhanje, ponavljajoča se driska, kri v blatu, nenadna izguba telesne mase, anoreksija, letargičnost, spremenjene vrednosti biokemičnih parametrov ledvic ali jeter, takoj prenehajte z uporabo tega zdravila in poiščite veterinarsko pomoč.
English: Half tablets should be returned to the original market container and may be stored for up to 7 days.
Slovenian: Razpolovljene tablete vrnjene v originalno embalažo lahko hranite največ 7 dni.
English: Renal and/or hepatic disorders have been reported in very rare cases in dogs administered the recommended treatment dose.
Slovenian: Zelo redko so poročali o ledvičnih in/ali jetrnih obolenjih pri psih, zdravljenih s priporočenimi odmerki.
English: In in-vitro canine whole blood assays, firocoxib exhibits approximately 380-fold selectivity for COX-2 over COX-1.
Slovenian: Raziskave krvi pri psu in vitro so pokazale, da firokoksib 380 krat bolj selektivno deluje na COX-2 kot na COX-1.
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
English: Administer 5 mg per kg bodyweight once daily.
Slovenian: Enkrat dnevno dajte 5 mg na kg telesne mase.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Firocoxib 57 mg
Slovenian: Firokoksib 57 mg
English: Firocoxib 227 mg
Slovenian: Firokoksib 227 mg
English: For the relief of pain and inflammation associated with osteoarthritis in dogs.
Slovenian: Za blažitev bolečin in vnetja, ki so povezani z osteoartritisom pri psih.
English: Special precautions for use in animals The recommended dose, as indicated in the dosing table, should not be exceeded.
Slovenian: Ne prekoračite priporočenega odmerka, ki je naveden v tabeli odmerkov.
English: COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Slovenian: Predvnetni dražljaj sproži nastanek COX-2 izoformne oblike encima, ki je po ugotovitvah prvotno odgovoren za sintezo prostanoidnih mediatorjev bolečine, vnetja in povišane telesne temperature.
English: Name and address of the manufacturer responsible for batch release
Slovenian: SPROŠČANJE SERIJE Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije
English: COX-2 is the isoform of the enzyme that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Slovenian: COX-2 izoformna oblika encima je po nekaterih ugotovitvah prvotno odgovorna za sintezo prostanoidnih mediatorjev bolečine, vnetja in povišane telesne temperature.
English: *The frequency of possible adverse effects is defined using the following convention: Rare (affects 1 to 10 animals in 10,000)
Slovenian: *Pogostost pojavljanja neželenih učinkov določa naslednja konvencija:
English: The treatment should be discontinued if any of these signs are observed: repeated diarrhoea, vomiting, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters.
Slovenian: Če se pojavijo stranski učinki kot so bruhanje, ponavljajoča se driska, kri v blatu, nenadna izguba telesne mase, anoreksija, letargičnost, spremenjene vrednosti biokemičnih parametrov ledvic ali jeter,
English: Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given non-steroidal anti-inflammatory drugs.
Slovenian: Pri psih zdravljenih z nesteroidnimi protivnetnimi zdravili se lahko na prebavilih stanje razjed povzročenih s kortikosteroidi poslabša.
English: Firocoxib 57 mg Firocoxib 227 mg
Slovenian: Firokoksib 57 mg Firokoksib 227 mg
English: The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Slovenian: Pri določitvi časa, ki mora miniti od prenehanja zdravljenja s prejšnjim zdravilom in pričetkom zdravljenja z zdravilom Previcox,, moramo upoštevati farmakokinetične lastnosti prejšnjega zdravila.
English: Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
Slovenian: Previcox 57 mg žvečljive tablete za pse Previcox 227 mg žvečljive tablete za pse
English: Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before the commencement of treatment with Previcox.
Slovenian: Zato je potrebno preden začnemo z zdravljenjem z zdravilom Previcox počakati vsaj 24 ur.
English: Previcox 227 mg chewable tablets for dogs
Slovenian: Previcox 227 mg žvečljive tablete za pse
English: In order to protect from moisture, store in the original package.
Slovenian: Hranite na suhem mestu v originalni ovojnini.
English: Previcox 57 mg chewable tablets for dogs
Slovenian: Previcox 57 mg žvečljive tablete za pse
English: Chewable tablet
Slovenian: Žvečljive tablete
English: Previcox 227 mg chewable tablets Firocoxib
Slovenian: Previcox 227 mg žvečljive tablete
English: Elimination is principally in the bile and gastrointestinal tract.
Slovenian: Izloča se predvsem z žolčem in preko črevesja.
English: Pain and inflammation associated with osteoarthritis.
Slovenian: Bolečina in vnetje, povezana z osteoartritisom pri psih.
English: Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk for renal toxicity.
Slovenian: Izogibajte se sočasni uporabi z drugimi nefrotoksičnimi zdravili, ker obstaja povečana nevarnost toksičnega vpliva na ledvice.
English: Concurrent administration of potentially nephrotoxic drugs should be avoided.
Slovenian: Izogibajte se sočasni uporabi z drugimi potencialno nefrotoksičnimi zdravili.
English: Previcox 57 mg chewable tablets Firocoxib
Slovenian: Previcox 57 mg žvečljive tablete
English: Use this product under strict veterinary monitoring where there is a risk of gastrointestinal bleeding, or if the animal previously displayed intolerance to NSAIDs.
Slovenian: Pri uporabi zdravila pri živalih, kjer obstaja tveganje za pojav želodčno-črevesnih krvavitev ali gre za živali z znano preobčutljivostjo na druga NSAID, morajo biti te živali pod strogim veterinarskim nadzorom.
English: Administer 5 mg per kg bodyweight once daily as presented in the table below for up to 3 days as needed, starting approximately 2 hours prior to surgery.
Slovenian: Zdravimo po potrebi do 3 zaporedne dni; prvi odmerek damo približno 2 uri pred operativnim posegom.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity.
Slovenian: hipovolemične ali imajo nizek krvni tlak, ker v teh primerih obstaja potencialna nevarnost za povečano toksičnost za ledvice.
English: Emesis and diarrhoea have occasionally been reported.
Slovenian: Občasno se pojavljata bruhanje in driska.
English: Not applicable
Slovenian: Navedba ni smiselna
English: Tranexamic acid
Slovenian: Traneksamična kislina
English: Tranexamic acid had not previously been associated with an increased risk of mortality and this has remained unchanged post-publication of the BART study.
Slovenian: Traneksamične kisline prej niso povezovali s povečanim tveganjem za smrtnost in to se niti po objavi študije BART ni spremenilo.
English: Tranexamic acid is a lysine analogue authorised for several indication since 1969.
Slovenian: Traneksamična kislina je analog lizina in je že od leta 1969 odobrena za več indikacij.
English: Acute venous or arterial thrombosis should constitute a contraindication.
Slovenian: Akutna venska ali arterijska tromboza bi morali predstavljati kontraindikacijo.
English: Detailed grounds for re-examination submitted by the marketing authorisation holder
Slovenian: Podrobni razlogi za ponovno presojo, ki jih je predložil imetnik dovoljenja za promet
English: Therefore, the CHMP concluded that a PK study should not be requested as a condition at this point in time.
Slovenian: Zato je odbor CHMP zaključil, da se farmakokinetična študija trenutno ne sme zahtevati kot pogoj.
English: The same is applicable for fibrinolytic conditions following consumption coagulopathy except in those with predominant activation of the fibrinolytic system with acute severe bleeding.
Slovenian: Enako velja za fibrinolitična stanja po porabni koagulopatiji, razen pri bolnikih s prevladujočo aktivacijo fibrinolitičnega sistema z akutno hudo krvavitvijo.
English: This document presents the conclusions on tranexamic acid.
Slovenian: V tem dokumentu so predstavljeni sklepi o traneksamični kislini.
English: For some conditions modifications to the wording were proposed, in order to bring them in line with current scientific knowledge on the use of TXA.
Slovenian: Za nekatere indikacije so bile predlagane spremembe besedila, da bi jih uskladili s sedanjimi znanstvenimi dognanji o uporabi traneksamične kisline.
English: The latest quality review of documents templates were taken into account during this review.
Slovenian: Med tem pregledom je bil upoštevan zadnji pregled kakovosti predlog za dokumente.
English: One MAH for tranexamic acid containing medicinal products expressed its disagreement with the CHMP Opinion, focusing its grounds for re-examination on the following points:
Slovenian: Eden od imetnikov dovoljenj za promet z zdravili, ki vsebujejo traneksamično kislino, je izrazil nesoglasje z mnenjem odbora CHMP in osredotočil svoje razloge za ponovno presojo na naslednje točke:
English: Having considered the detailed grounds for re-examination submitted by the MAH in writing, the CHMP considered that no additional conditions were necessary to ensure the safe and effective use of tranexamic acid.
Slovenian: Po proučitvi podrobnih razlogov za ponovno presojo, ki jih je imetnik dovoljenja za promet pisno predložil, je odbor CHMP sklenil, da za zagotovitev varne in učinkovite uporabe traneksamične kisline niso potrebni nobeni dodatni pogoji.
English: The MAH was not convinced that the fulfilment of a condition such as performing a pharmacokinetic study in children was an essential condition for the safe and effective use of tranexamic acid IV in adults.
Slovenian: • Imetnik dovoljenja za promet ni bil prepričan, da je izpolnitev pogoja, kot je izvedba farmakokinetične študije pri otrocih, osnovni pogoj za varno in učinkovito uporabo traneksamične kisline IV pri odraslih.
English: The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for aprotinin, aminocaproic acid and tranexamic acid (see Annex I).
Slovenian: • odbor je upošteval postopek po členu 31 Direktive 2001/83/ES za aprotinin, aminokaprojsko kislino in traneksamično kislino (glejte Prilogo I);
English: Therefore the CHMP concluded that the balance of risks and benefits for tranexamic acid is positive under normal conditions of use subject to the revision of the indications as follows:
Slovenian: je odbor CHMP zaključil, da je razmerje med tveganji in koristmi za traneksamično kislino pozitivno pri običajnih pogojih uporabe in z naslednjo revizijo indikacij:
English: A list of indications for which the CHMP considered that the benefit risk balance remains positive is presented below.
Slovenian: Seznam indikacij, za katere je odbor CHMP menil, da zanje ostaja razmerje med tveganji in koristmi pozitivno, je na voljo spodaj.
English: The Committee considered that the product information should be updated.
Slovenian: • odbor je presodil, da je treba posodobiti informacije o zdravilih.
English: Having considered the data presented, the CHMP noted that there are ongoing PK studies in children that could provide valuable information.
Slovenian: Ob upoštevanju predstavljenih podatkov je odbor CHMP ugotovil, da že potekajo farmakokinetične študije pri otrocih, ki bi lahko prinesle koristne informacije.
English: The results of the BART trial did not have a negative impact on the benefit risk profile of TXA.
Slovenian: Rezultati preskušanja BART niso negativno vplivali na profil koristi in tveganja za traneksamično kislino.
English: Thromboembolic events, including interaction with oestrogens have been reported.
Slovenian: Poročali so o trombemboličnih dogodkih, vključno z medsebojnim delovanjem z estrogeni.
English: In addition, information on convulsions and visual disturbances including impaired colour vision are adverse events which can be serious and have been reported, but these risks had not been considered in the current authorised product information.
Slovenian: Poleg tega so med neželenimi učinki konvulzije in motnje vida, vključno s poslabšanjem barvnega vida, ki so lahko resne in o katerih so poročali, toda ta tveganja niso bila upoštevana v podatkih o zdravilih, ki so trenutno odobrena.
English: The final study results of these clinical trials should be considered before recommending the need of additional studies.
Slovenian: Pred priporočanjem, da so potrebne dodatne študije, je treba upoštevati končne rezultate teh kliničnih preskušanj.
English: Taking into account all the available information on safety and efficacy, the Committee agreed on the variation of the marketing authorisation with the balance of the risks and benefits considered positive in the following revised indications for TXA:
Slovenian: Ob upoštevanju vseh razpoložljivih informacij o varnosti in učinkovitosti je Odbor pristal na spremembo dovoljenj za promet z zdravili, ker meni, da je razmerje med tveganji in koristmi pozitivno za naslednje revidirane indikacije za traneksamično kislino:
English: The safety profile of TXA has evolved since its authorisation, and safety data has accumulated over the years.
Slovenian: Po odobritvi traneksamične kisline se je varnostni profil te učinkovine še povečal in podatkov o varnosti je bilo skozi leta čedalje več.
English: Overall summary of the scientific evaluation of referral on antifibrinolytics Tranexamic acid containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja napotitve za antifibrinolitike Zdravila, ki vsebujejo traneksamično kislino (glejte Prilogo I)
English: The ongoing studies could provide some relevant PK data in different age stratum and some pharmacodynamic data, which is considered of interest.
Slovenian: Potekajoče študije bi lahko prinesle nekatere pomembne farmakokinetične podatke za različne starostne skupine in nekaj farmakodinamičnih podatkov, ki bi lahko bili zanimivi.
English: The CHMP considered also the adverse reactions profile, including new adverse events (some of which serious) associated with the use of TXA.
Slovenian: Upošteval je tudi profil neželenih učinkov, vključno z novimi neželenimi učinki (med katerimi je nekaj resnih), povezanih z uporabo traneksamične kisline;
English: This PK study had been requested by the CHMP in the article 31 referral on antifibrinolytics containing aprotinin, aminocaproic acid and tranexamic acid.
Slovenian: To farmakokinetično študijo je zahteval odbor CHMP v napotitvenem postopku po členu 31 za antifibrinolitike, ki vsebujejo aprotinin, aminokaprojsko kislino in traneksamično kislino.
English: On the basis of the above, the Committee recommended the variation to the terms of the marketing authorisation for the medicinal products containing tranexamic acid referred to in Annex I for which the amendments to the product information are set out in annex III of the opinion.
Slovenian: Na podlagi navedenega je Odbor priporočil spremembo pogojev za dovoljenja za promet z zdravili, ki vsebujejo traneksamično kislino, naštetimi v Prilogi I. Spremembe informacij o zdravilih so navedene v Prilogi III tega mnenja.
English: The MAHs are reminded that any new information on the use of TXA in children is considered valuable.
Slovenian: Imetniki dovoljenj za promet z zdravili naj imajo v mislih, da vsakršne nove informacije o uporabi traneksamične kisline pri otrocih veljajo za koristne.
English: Dermatitis allergic, vascular disorders, such as malaise with hypotension, with or without loss of consciousness and arterial or venous thrombosis, and hypersensitivity reactions including anaphylaxis have been reported.
Slovenian: Poročali so o alergijskem dermatitisu, žilnih motnjah, kot je slabo počutje s hipotenzijo, izgubo zavesti in arterijsko ali vensko trombozo ali brez njih, ter o preobčutljivostnih reakcijah, vključno z anafilaksijo.
English: In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of TXA, and considering the adverse reactions profile (some of which serious) associated with the use of TXA, the CHMP considered that some of these indications should be removed.
Slovenian: Ob upoštevanju ugotovljenih resnih omejitev podatkov o učinkovitosti, razpoložljivih novih dokazov in/ali sedanjega medicinskega znanja o uporabi traneksamične kisline ter profila neželenih učinkov (med katerimi je nekaj resnih), povezanih z uporabo traneksamične kisline, je odbor CHMP menil, da je treba nekatere od teh indikacij odstraniti.
English: The MAH informed that for children, some recent pharmacokinetic studies conducted with tranexamic acid in the paediatric population should provide relevant information.
Slovenian: • Imetnik dovoljenja za promet je poročal, da bi nekatere nedavne farmakokinetične študije, opravljene s traneksamično kislino pri pediatrični populaciji, morale dati ustrezne informacije o uporabi pri otrocih.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations for tranexamic acid containing medicinal products presented by the EMA
Slovenian: Znanstveni zaključki in razlogi za spremembo pogojev dovoljenj za promet z zdravili z vsebnostjo traneksamične kisline, ki jih je predstavila Evropska agencija za zdravila
English: The Committee considered that evidence from randomised clinical trials and observational studies support the use of tranexamic acid in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Slovenian: • odbor meni, da dokazi iz randomiziranih kliničnih preskušanj in opazovalnih študij podpirajo uporabo traneksamične kisline pri bolnikih, ki imajo posege na zobeh in druge kirurške posege ter pri bolnikih, ki so v nevarnosti za zaplete zaradi krvavitve;
English: In addition to cardiac surgery, the CHMP considered that sufficient evidence is available on the safety and efficacy of TXA in other indications, including in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Slovenian: Po mnenju odbora CHMP je poleg srčnih operacij na voljo dovolj dokazov o varnosti in učinkovitosti traneksamične kisline tudi za druge indikacije, vključno s posegi na zobeh in drugimi kirurškimi posegi ter pri bolnikih, ki so v nevarnosti za zaplete zaradi krvavitve.
English: In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of TXA, and considering the adverse reactions profile (some of which serious) associated with the use of TXA, the CHMP considered that for some of the therapeutic indications the benefits no longer outweigh the risks and therefore they should be removed.
Slovenian: • ob upoštevanju ugotovljenih resnih omejitev podatkov o učinkovitosti, razpoložljivih novih dokazov in/ali sedanjega medicinskega znanja o uporabi traneksamične kisline ter profila neželenih učinkov (med katerimi je nekaj resnih), povezanih z uporabo traneksamične kisline, je odbor CHMP menil, da za nekatere terapevtske indikacije koristi ne odtehtajo več tveganj, zato je te indikacije treba odstraniti;
English: Haematuria and the risk for urethral obstruction should also be included as warnings.
Slovenian: Med opozorila je treba vključiti tudi hematurijo in tveganje za obstrukcijo sečnice.
English: Grounds for amendment of the marketing authorisations of tranexamic acid containing medicinal products listed in Annex I
Slovenian: Podlaga za spremembo dovoljenj za promet z zdravili, ki vsebujejo traneksamično kislino, naštetimi v Prilogi I