FrancophonIA/ELRC3.0 huggingface dataset:
English: • The recommended dose is one 10 mg tablet each day.
Slovenian: • Priporočeni odmerek je ena 10 mg tableta vsak dan.
English: LOCF: Last observation carried forward
Slovenian: LOCF: Prenos zadnjega opažanja [Last observation carried forward]
English: Non-inferior to glipizide + metformin p-value < 0.0001
Slovenian: Neinferiorno glede na glipizid + metformin Vrednost p < 0,0001
English: glimepiride 4 mg/day; Metformin (immediate- or extended-release formulations) ≥1500 mg/day plus maximum tolerated dose, which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrolment.
Slovenian: Glimepirid 4 mg/dan; Metformin (oblike s takojšnjim ali podaljšanim sproščanjem) ≥ 1500 mg/dan ter največji tolerirani odmerek (ki mora biti vsaj polovičen maksimalni odmerek) sulfonilsečnine vsaj 8 tednov pred zajetjem v študijo.
English: Combination of a single dose of dapagliflozin 20 mg and simvastatin (a CYP3A4 substrate) resulted in a 19 % increase in AUC of simvastatin and 31 % increase in AUC of simvastatin acid.
Slovenian: Kombinacija enkratnega odmerka 20 mg dapagliflozina in simvastatina (substrata CYP3A4) je povzročila 19-odstotno povečanje AUC simvastatina in 31-odstotno% povečanje AUC simvastatinske kisline.
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95 % Confidence interval [CI]: 0.58, 1.07), indicating that in this analysis Forxiga is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Slovenian: Razmerje ogroženosti z dapagliflozinom v primerjavi s primerjalnim zdravilom je bilo 0,79 (95 % interval zaupanja [IZ]: 0,58; 1,07), kar nakazuje, da v tej analizi zdravilo Forxiga ni bilo povezano s povečanjem kardiovaskularnega tveganja pri bolnikih s sladkorno boleznijo tipa 2.
English: In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), Forxiga was evaluated as add-on therapy to metformin compared with a sulphonylurea (glipizide) as add-on therapy to metformin in subjects with inadequate glycaemic control (HbA1c > 6.5 % and ≤ 10 %).
Slovenian: V 52-tedenski, z zdravilno učinkovino kontrolirani študiji neinferiornosti (z 52-tedenskim in 104-tedenskim obdobjem podaljšanja), so zdravilo Forxiga ocenjevali kot dodatek k zdravljenju z metforminom v primerjavi s sulfonilsečnino (glipizid) kot dodatkom k zdravljenju z metforminom pri osebah z neustrezno urejenostjo glikemije (HbA1c > 6,5 % in ≤ 10 %).
English: At 52, 104 and 208 weeks, a significantly lower proportion of subjects in the group treated with dapagliflozin (3.5 %, 4.3 % and 5.0 %, respectively) experienced at least one event of hypoglycaemia compared to the group treated with glipizide (40.8 %, 47.0 % and 50.0 %, respectively).
Slovenian: 52., 104. in 208. teden je imel vsaj eno hipoglikemijo značilno manjši delež oseb, ki so prejemale dapagliflozin (3,5 %, 4,3 % in 5,0 %) v primerjavi s skupino, zdravljeno z glipizidom (40,8 %, 47,0 % in 50,0 %).
English: Subjects with mean daily insulin dose reduction of at least 10 % (%)
Slovenian: Osebe z zmanjšanjem povprečnega dnevnega odmerka insulina za vsaj a
English: Columns 1 and 2, HbA1c analysed using LOCF (see footnote d); Columns 3 and 4, HbA1c analysed using LRM (see footnote e) Least squares mean adjusted for baseline value LOCF: Last observation (prior to rescue for rescued subjects) carried forward LRM: Longitudinal repeated measures analysis p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product(s)
Slovenian: Stolpca 1 in 2, HbA1c analiziran po metodi LOCF (glejte opombo d), stolpca 3 in 4, HbA1c analiziran z metodo LRM (glejte opombo e) Povprečje najmanjših kvadratov, prilagojeno za izhodiščno vrednost LOCF: Prenos zadnjega opažanja (pred rešilnim zdravljenjem za preiskovance s takšnim zdravljenjem) [Last observation carried forward] eLRM: longitudinalna analiza s ponovljenimi meritvami Vrednost p < 0,0001 v primerjavi s kombinacijo placebo + peroralni antidiabetik/antidiabetiki
English: Forxiga has not been studied in severe renal impairment (CrCl < 30 ml/min or eGFR < 30 ml/min/1.73 m 2) or end-stage renal disease (ESRD).
Slovenian: Zdravilo Forxiga ni bilo raziskano pri hudi okvari ledvic (CrCl < 30 ml/min ali eGFR < 30 ml/min/1,73 m 2) ali pri končni odpovedi ledvic (ESRD - end-stage renal disease).
English: Effect of dapagliflozin on other medicinal products In interaction studies conducted in healthy subjects, using mainly a single-dose design, dapagliflozin did not alter the pharmacokinetics of metformin, pioglitazone, sitagliptin, glimepiride, hydrochlorothiazide, bumetanide, valsartan, digoxin (a P-gp substrate) or warfarin (S-warfarin, a CYP2C9 substrate), or the anticoagulatory effects of warfarin as measured by INR.
Slovenian: V študijah medsebojnega delovanja pri zdravih preiskovancih, ki so bile v glavnem izvedene po raziskovalnem načrtu z uporabo enkratnega odmerka, dapagliflozin ni spremenil farmakokinetike metformina, pioglitazona, sitagliptina, glimepirida, hidroklorotiazida, bumetanida, valsartana, digoksina (ki je substrat P-gp ) ali varfarina (S-varfarina, ki je substrat CYP2C9 ); prav tako ni spremenil antikoagulantnih učinkov varfarina, merjenih z INR.
English: Forxiga is not recommended for use in patients with moderate to severe renal impairment (patients with CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2).
Slovenian: Zdravila Forxiga ni priporočljivo uporabljati pri bolnikih z zmerno do hudo okvaro ledvic (bolnikih s CrCl < 60 ml/min ali eGFR < 60 ml/min/1,73 m 2).
English: tablet core: microcrystalline cellulose (E460i), anhydrous lactose (see section 2 ‘Forxiga contains lactose'), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b).
Slovenian: • Druge sestavine zdravila so: jedro tablete: mikrokristalna celuloza (E460i), brezvodna laktoza (glejte poglavje 2 "Zdravilo Forxiga vsebuje laktozo"), krospovidon (E1202), silicijev dioksid (E551), magnezijev stearat (E470b).
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo c
Slovenian: HbA1c (%) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo c
English: See section 4.4 Reported in ≥ 2 % of subjects and ≥ 1 % more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Slovenian: Opisano pri ≥ 2 % preiskovancev ter pri ≥ 1 % več in pri vsaj 3 preiskovancih več med uporabo 10 mg dapagliflozina kot med uporabo placeba.
English: Forxiga 5 mg film-coated tablets EU/1/12/795/001 14 film-coated tablets EU/1/12/795/002 28 film-coated tablets EU/1/12/795/003 98 film-coated tablets EU/1/12/795/004 30 x 1 (unit dose) film-coated tablets EU/1/12/795/005 90 x 1 (unit dose) film-coated tablets
Slovenian: Forxiga 5 mg filmsko obložene tablete EU/1/12/795/001 14 filmsko obloženih tablet EU/1/12/795/002 28 filmsko obloženih tablet EU/1/12/795/003 98 filmsko obloženih tablet EU/1/12/795/004 30 x 1 (enkratni odmerek) filmsko obložena tableta EU/1/12/795/005 90 x 1 (enkratni odmerek) filmsko obložena tableta
English: Forxiga 10 mg film-coated tablets EU/1/12/795/006 14 film-coated tablets EU/1/12/795/007 28 film-coated tablets EU/1/12/795/008 98 film-coated tablets EU/1/12/795/009 30 x 1 (unit dose) film-coated tablets EU/1/12/795/010 90 x 1 (unit dose) film-coated tablets
Slovenian: Forxiga 10 mg filmsko obložene tablete EU/1/12/795/006 14 filmsko obloženih tablet EU/1/12/795/007 28 filmsko obloženih tablet EU/1/12/795/008 98 filmsko obloženih tablet EU/1/12/795/009 30 x 1 (enkratni odmerek) filmsko obložena tableta EU/1/12/795/010 90 x 1 (enkratni odmerek) filmsko obložena tableta
English: Dapagliflozin 10 mg
Slovenian: Monoterapija dapagliflozin 10 mg placebo
English: Forxiga 10 mg tablets dapagliflozin
Slovenian: Forxiga 10 mg tablete dapagliflozin
English: Forxiga 5 mg tablets dapagliflozin
Slovenian: Forxiga 5 mg tablete dapagliflozin
English: (95 % CI) Subjects (%) achieving: HbA1c < 7 % Adjusted for baseline Body weight (kg) Baseline (mean) Change from baseline Difference from placebo c
Slovenian: (95 % IZ) Preiskovanci (%), ki so dosegli: HbA1c < 7 % Prilagojeno za izhodišče Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo c
English: LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Slovenian: Povprečje najmanjših kvadratov, prilagojeno za izhodiščno vrednost in prisotnost peroralnega antidiabetika Vrednost p < 0,0001 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika Vrednost p < 0,05 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika Povečevanje insulinske sheme (vključno s kratkodelujočim, srednjedolgodelujočim in bazalnim insulinom) je bilo dovoljeno le, če so bolniki izpolnjevali vnaprej določena merila glede glukoze v plazmi na tešče.
English: Forxiga 5 mg film-coated tablets Forxiga 10 mg film-coated tablets
Slovenian: Forxiga 5 mg filmsko obložene tablete Forxiga 10 mg filmsko obložene tablete
English: Forxiga 10 mg film-coated tablets
Slovenian: Forxiga 10 mg filmsko obložene tablete
English: Forxiga 5 mg film-coated tablets
Slovenian: Forxiga 5 mg filmsko obložene tablete
English: Randomised and treated subjects with baseline and at least 1 post-baseline efficacy measurement Least squares mean adjusted for baseline value
Slovenian: Randomizirane in zdravljene osebe z izhodiščno in vsaj še eno poizhodiščno meritvijo učinkovitosti c
English: LOCF: Last observation (prior to rescue for rescued subjects) carried forward All randomised subjects who took at least one dose of double-blind study medication during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo Not evaluated for statistical significance as a result of the sequential testing procedure for secondary end points
Slovenian: Povprečje najmanjših kvadratov, prilagojeno za izhodiščno vrednost Vrednost p < 0,0001 v primerjavi s placebom Ni ocenjeno za statistično značilnost zaradi postopka zaporednega preskušanja za sekundarne opazovane dogodke
English: Forxiga 5 mg film-coated tablets dapagliflozin
Slovenian: Forxiga 5 mg filmsko obložene tablete dapagliflozin
English: Forxiga 10 mg film-coated tablets dapagliflozin
Slovenian: Forxiga 10 mg filmsko obložene tablete dapagliflozin
English: Forxiga 5 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Slovenian: Forxiga 5 mg filmsko obložene tablete Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 5 mg dapagliflozina.
English: Forxiga 10 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Slovenian: Forxiga 10 mg filmsko obložene tablete Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 10 mg dapagliflozina.
English: Baseline (mean) Change from baseline Difference from placebo c
Slovenian: Izhodišče (povprečje) Sprememba od izhodišča Razlika v primerjavi s placebom c
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to10 mg dapagliflozin
Slovenian: Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 10 mg dapagliflozina.
English: Forxiga contains lactose
Slovenian: Zdravilo Forxiga vsebuje laktozo
English: inhaler (ABS/PE/PP) 3 inhalers (3 x 60 doses)
Slovenian: 3 inhalatorji (3 x 60 odmerkov)
English: This summary was last updated in December 2016.
Slovenian: Povzetek je bil nazadnje posodobljen decembra 2016.
English: Treatment is once daily.
Slovenian: Zdravljenje poteka enkrat dnevno.
English: EMA/261874/2008 EMEA/V/C/000142
Slovenian: EMEA/261874/2008 EMEA/V/C/000142
English: The overall duration of treatment depends on the horse's response, but should not exceed 14 days.
Slovenian: Skupno trajanje zdravljenja je odvisno od odziva konja, vendar ne sme trajati več kot 14 dni.
English: The full EPAR for Equioxx can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Equioxx je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Equioxx on 25 June 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Equioxx, veljavno po vsej Evropski uniji, izdala 25. junija 2008.
English: This is a summary of the European public assessment report (EPAR) for Equioxx.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Equioxx.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Equioxx's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Equioxx večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The dose depends on the bodyweight of the animal except for the tablets which are for horses of 450 to 600 kg bodyweight and where the dose is one tablet.
Slovenian: Odmerek je odvisen od telesne mase živali, razen pri tabletah, ki se lahko dajejo samo konjem s telesno maso med 450 in 600 kg, in sicer v odmerku ene tablete.
English: Two forms of a medicine are bioequivalent when they produce the same levels of active substance in the body.
Slovenian: Dve zdravili sta biološko enakovredni, kadar dosegata enake ravni zdravilne učinkovine v telesu.
English: vedaprofen.
Slovenian: Zdravilo
English: This authorisation was based on the authorisation granted to Previcox in 2004 (‘informed consent').
Slovenian: Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Previcox, ki je bilo izdano leta 2004 (uporaba dokumentacije s soglasjem).
English: These are typically mild and resolve without treatment.
Slovenian: Ti so običajno blagi in izzvenijo z zdravljenjem.
English: Other information about Equioxx:
Slovenian: Druge informacije o zdravilu Equioxx:
English: Equioxx firocoxib
Slovenian: Equioxx firokoksib
English: People should avoid contact of the medicine with eyes and skin and wash their hands after handling the product.
Slovenian: Ljudje se morajo izogibati stiku z očmi in kožo ter si po uporabi zdravila umiti roke.
English: It is not intended to provide practical advice on how to use Equioxx.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The withdrawal period for meat from horses treated with Equioxx is 26 days.
Slovenian: Karenca za meso konj, zdravljenih z zdravilom Equioxx, je 26 dni.
English: Two field studies investigated the effectiveness of Equioxx oral paste in treating horses with lameness of more than 4 weeks due to osteoarthritis.
Slovenian: V dveh terenskih študijah so proučevali učinkovitost peroralne paste zdravila Equioxx pri zdravljenju konjev z več kot štiritedensko šepavostjo zaradi osteoartritisa.
English: The active substance in Equioxx, firocoxib, is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘cyclo-oygenase-s (COX-2) inhibitors' (or Coxibs).
Slovenian: Zdravilna učinkovina v zdravilu Equioxx, firokoksib, je nesteroidno protivnetno zdravilo (NSAID), ki spada v skupino zdravil, imenovanih inhibitorji ciklooksigenaze-2 (COX-2) (oziroma koksibi).
English: Women of child-bearing age should avoid contact with, or wear disposable gloves, when giving the product.
Slovenian: Ženske v rodni dobi se morajo izogibati stiku z zdravilom ali pri njegovem dajanju nositi rokavice za enkratno uporabo.
English: Equioxx is a medicine used in horses to relieve pain and inflammation in the joints caused by osteoarthritis (a long-term disease causing damage and pain in the joints) and to reduce the lameness that is associated with the disease.
Slovenian: Zdravilo Equioxx se uporablja pri konjih za lajšanje bolečin in vnetja v sklepih, ki jih povzroča osteoartritis (dolgotrajna bolezen, ki povzroča okvaro in bolečine v sklepih), ter zmanjšanje šepavosti, povezane s tem obolenjem.
English: The studies showed that Equioxx oral paste given daily for 14 days was as effective as the comparator medicines.
Slovenian: Študiji sta pokazali, da je 14-dnevno vsakdanje jemanje peroralne paste zdravila Equioxx enako učinkovito kot primerjalna zdravila.
English: What are the risks associated with Equioxx?
Slovenian: Kakšna tveganja so povezana z zdravilom Equioxx?
English: This means that the solution for injection and the chewable tablets can be expected to produce similar results to the oral paste.
Slovenian: To pomeni, da naj bi raztopina za injiciranje in žvečljive tablete dosegle podobne rezultate kot peroralna pasta.
English: For the full list of all side effects reported with Equioxx and the full list of restrictions, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Equioxx, in omejitev glejte navodilo za uporabo.
English: What benefits of Equioxx have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Equioxx izkazalo v študijah?
English: What is Equioxx and what is it used for?
Slovenian: Kaj je zdravilo Equioxx in za kaj se uporablja?
English: If the medicine is accidentally swallowed or someone accidentally injects themselves, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Slovenian: Če človek zdravilo nenamerno zaužije ali mu ga nekdo nenamerno vbrizga, se mora nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali ovojnino.
English: Equioxx is available as a solution for injection, an oral paste and chewable tablets.
Slovenian: Zdravilo Equioxx je na voljo kot raztopina za injiciranje, peroralna pasta in žvečljive tablete.
English: By reducing the production of prostaglandins, Equioxx helps reduce the responses of inflammation, including pain.
Slovenian: Equioxx z zmanjšanjem nastajanja prostaglandinov pomaga zmanjšati simptome vnetja, vključno z bolečino.
English: Similarly Equioxx oral paste and Equioxx chewable tablets have been shown to be bioequivalent.
Slovenian: Podobno je bilo dokazano, da sta tudi peroralna pasta in žvečljive tablete zdravila Equioxx biološko enakovredne.
English: Why is Equioxx approved?
Slovenian: Zakaj je bilo zdravilo Equioxx odobreno?
English: It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
Slovenian: Z zaviranjem encima COX-2 zmanjša nastajanja prostaglandinov, tj. snovi, ki sodelujejo pri vnetnem procesu.
English: The most common side effects with Equioxx (which may affect more than 1 in 10 horses) are ulcers or sores of the lining of the mouth or the skin around the mouth.
Slovenian: Najpogostejši neželeni učinki zdravila Equioxx (ki lahko prizadenejo več kot 1 od 10 konjev) so ulkusi ali razjede na ustni sluznici ali koži okrog ust.
English: The solution for injection is given into a vein while the paste and tablets are given by mouth.
Slovenian: Raztopina za injiciranje se daje v veno, medtem ko se pasta in tablete jemljejo peroralno.
English: The most common side effects with Equioxx (which may affect up to 1 in 100 horses) are salivation and lip and tongue swelling associated with the mouth sores.
Slovenian: Najpogostejši neželeni učinki zdravila Equioxx (ki lahko prizadenejo največ 1 od 100 konjev) so slinjenje ter oteklina ustnic in jezika zaradi razjed v ustih.
English: It contains the active substance firocoxib.
Slovenian: Vsebuje zdravilno učinkovino firokoksib.
English: One study in the USA compared Equioxx to another NSAID medicine, phenylbutazone, and the second study in Europe compared Equioxx to the NSAID
Slovenian: V prvi študiji, ki so jo izvedli v ZDA, so zdravilo Equioxx primerjali z drugim nesteroidnim protivnetnim zdravilom, fenilbutazonom, v drugi študiji, ki je potekala v Evropi, pa so ga primerjali nesteroidnim protivnetnim zdravilom vedaprofenom.
English: Equioxx must not be used at the same time as corticosteroid medicines or other NSAIDs.
Slovenian: Sočasno se ne sme uporabljati s kortikosteroidi ali drugimi nesteroidnimi priotivnetnimi zdravili.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Equioxx, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Slovenian: V povzetek glavnih značilnosti zdravila Equioxx in navodilo za uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
English: Equioxx oral paste and Equioxx solution for injection have been studied in a laboratory and found to be bioequivalent.
Slovenian: Peroralno pasto in raztopino za injiciranje zdravila Equioxx so proučevali v laboratorijskih študijah, na podlagi katerih so ugotovili, da sta biološko enakovredni.
English: For more information about treatment with Equioxx, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Equioxx naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: For practical information about using Equioxx, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Equioxx naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: How does Equioxx work?
Slovenian: Kako zdravilo Equioxx deluje?
English: Equioxx must not be used in horses suffering from stomach or gut disorders and bleeding, nor in case of reduced liver, heart or kidney function or bleeding disorders.
Slovenian: Prav tako se ne sme uporabljati pri tistih živalih, ki imajo oslabljeno delovanje jeter, srca in ledvic ter motnje v strjevanju krvi.
English: Equioxx can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Equioxx je le na recept.
English: How is Equioxx used?
Slovenian: Kako se zdravilo Equioxx uporablja?
English: Equioxx must not be used in breeding, pregnant or lactating horses.
Slovenian: Ne sme se uporabljati pri rejnih živalih, brejih živalih ali živalih v laktaciji.
English: This means that Thorinane is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je zelo podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: What measures are being taken to ensure the safe and effective use of Thorinane?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Thorinane?
English: The full EPAR for Thorinane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Thorinane je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Thorinane.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Thorinane.
English: Other information about Thorinane
Slovenian: Druge informacije o zdravilu Thorinane