FrancophonIA/ELRC3.0 huggingface dataset:
English: For the treatment and prevention of flea (Ctenocephalides felis) infestations in dogs where one or more of the following indications are required concurrently: - prevention of heartworm disease (L3, L4 Dirofilaria immitis), - prevention of angiostrongylosis by reducing the level of infection with immature adult (L5)
Slovenian: Za zdravljenje in preprečevanje infestacij z bolhami (Ctenocephalides felis) pri psih, kjer se sočasno pojavlja ena ali več naslednjih indikacij: - preprečevanje dirofilarioze (L3, L4 Dirofilaria immitis), - preprečevanje angiostrongiloze z zmanjšanjem stopnje okužbe z nezrelo odraslo obliko (L5) nematoda Angiostrongylus vasorum, - zdravljenje okužb z želodčno-črevesnimi nematodi, ki jih povzročajo kavljasti črvi (L4, nezrele odrasle oblike (L5) in odrasle oblike Ancylostoma caninum), valjasti črvi (nezrele odrasle oblike L5 in odrasle oblike Toxocara canis ter odrasle oblike Toxascaris leonina) in bičeglavci (odrasle oblike Trichuris vulpis).
English: The veterinary medicinal product should be administered with food or immediately after feeding.
Slovenian: Zdravilo dajemo s hrano ali takoj po obroku.
English: Trifexis 1620 mg/27 mg tablets:
Slovenian: Trifexis 1620 mg/27 mg tablete:
English: As the safety of the veterinary medicinal product in male dogs used for breeding has not been determined, it should only be used according to the benefit-risk assessment of the responsible veterinarian.
Slovenian: Ker varnost zdravila pri pasjih samcih za razplod še ni ugotovljena, se sme to zdravilo uporabljati samo skladno z oceno razmerja med koristmi in tveganji, ki jo opravi odgovorni veterinar.
English: 4347 and no dimples
Slovenian: 4347 in brez vdolbinic
English: Trifexis 665 mg/11.1 mg spinosad 665 mg/milbemycin oxime 11.1 mg
Slovenian: Trifexis 665 mg/11,1 mg spinosad 665 mg/milbemicin oksim 11,1 mg
English: In rats dosed with milbemycin A4 5-oxime, the main metabolites identified in urine and faeces were mono-, di-, and trihydroxy milbemycin A4 5-oximes.
Slovenian: Ipodganah, ki so dobivale milbemicin A4 5-oksim, so kot glavne presnovke v urinu in blatu opredelili mono-, di- in trihidroksi milbemicin A4 5-oksime.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Trifexis 1620 mg/27 mg spinosad 1620 mg/milbemycin oxime 27.0 mg
Slovenian: Trifexis 1620 mg/27 mg spinosad 1620 mg/milbemicin oksim 27,0 mg
English: In adult dogs, after repeated oral administration of spinosad and milbemycin oxime for six consecutive months, increases in elimination half-lives were observed up to month 3.
Slovenian: Pri odraslih psih večkratno peroralno dajanje spinosada in milbemicin oksima za šest zaporednih mesecev povzroči povečanje končnega razpolovnega časa do 3. meseca.
English: In juvenile dogs, repeated oral administration of spinosad and milbemycin oxime over six months resulted in the trough plasma concentrations of spinosad and milbemycin increasing throughout the study.
Slovenian: Pri mladih psih je večkratno šestmesečno peroralno dajanje spinosada in milbemicin oksima povzročilo povečevanje najnižje koncentracije spinosada in milbemicin oksima v plazmi ves čas študije.
English: spinosad 270 mg/milbemycin oxime 4.5 mg spinosad 425 mg/milbemycin oxime 7.1 mg spinosad 665 mg/milbemycin oxime 11.1 mg spinosad 1040 mg/milbemycin oxime 17.4 mg spinosad 1620 mg/milbemycin oxime 27 mg
Slovenian: spinosad 270 mg/milbemicin oksim 4,5 mg spinosad 425 mg/milbemicin oksim 7,1 mg spinosad 665 mg/milbemicin oksim 11,1 mg spinosad 1040 mg/milbemicin oksim 17,4 mg spinosad 1620 mg/milbemicin oksim 27 mg
English: Trifexis 665 mg/11.1 mg tablets:
Slovenian: Trifexis 665 mg/11,1 mg tablete:
English: 4349 and 4 dimples
Slovenian: 4349 in 4 vdolbinice
English: Dosage:
Slovenian: Odmerjanje:
English: Post-marketing reports following the concomitant use of spinosad with ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Slovenian: Izkušnje uporabe zdravila kažejo, da je prišlo pri psih ob sočasni uporabi spinosada z ivermektinom do tresenja/trzanja, salivacije/slinjenja, epileptičnih napadov, ataksije, midriaze, slepote in dezorientacije.
English: This product should therefore only be used during pregnancy and lactation according to the benefit-risk assessment of the responsible veterinarian.
Slovenian: Zato se sme v obdobju brejosti ali laktacije to zdravilo uporabljati samo skladno z oceno razmerja med koristmi in tveganji, ki jo opravi odgovorni veterinar.
English: Spinosad starts killing fleas 30 minutes after administration; 100% of fleas are dead/moribund within 4 hours post-treatment.
Slovenian: Spinosad začne pobijati bolhe 30 minut po dajanju.
English: Fleas may be observed for a period of time after administration of the veterinary medicinal product due to the emergence of adult fleas from pupae already present in the environment.
Slovenian: Bolhe se lahko zaradi razvoja odraslih bolh iz bub, ki so že v okolju, pojavljajo še nekaj časa tudi v obdobju po dajanju zdravila.
English: Trifexis 1040 mg/17.4 mg spinosad 1040 mg/milbemycin oxime 17.4 mg
Slovenian: Trifexis 1040 mg/17,4 mg spinosad 1040 mg/milbemicin oksim 17,4 mg
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: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH PRETISNI OMOT
English: Trifexis 1040 mg/17.4 mg tablets:
Slovenian: Trifexis 1040 mg/17,4 mg tablete:
English: 4333 and 2 dimples
Slovenian: 4333 in 2 vdolbinici
English: EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg)
Slovenian: EU/2/13/155/001 (1 tableta, 270 mg/4,5 mg) EU/2/13/155/002 (1 x 3 tablete, 270 mg/4,5 mg) EU/2/13/155/003 (1 x 6 tablet, 270 mg/4,5 mg) EU/2/13/155/004 (1 tableta, 425 mg/7,1 mg) EU/2/13/155/005 (1 x 3 tablete, 425 mg/7,1 mg) EU/2/13/155/006 (1 x 6 tablet, 425 mg/7,1 mg) EU/2/13/155/007 (1 tableta, 665 mg/11,1 mg)
English: EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg) EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 tablets, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 tablets, 665 mg/11.1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 tablets, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 tablets, 1040 mg/17.4 mg) EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg) EU/2/13/155/014 (1 x 3 tablets, 1620 mg/27.0 mg) EU/2/13/155/015 (1 x 6 tablets, 1620 mg/27.0 mg)
Slovenian: EU/2/13/155/001 (1 tableta, 270 mg/4,5 mg) EU/2/13/155/002 (1 x 3 tablete, 270 mg/4,5 mg) EU/2/13/155/003 (1 x 6 tablet, 270 mg/4,5 mg) EU/2/13/155/004 (1 tableta, 425 mg/7,1 mg) EU/2/13/155/005 (1 x 3 tablete, 425 mg/7,1 mg) EU/2/13/155/006 (1 x 6 tablet 425 mg/7,1 mg) EU/2/13/155/007 (1 tableta, 665 mg/11,1 mg) EU/2/13/155/008 (1 x 3 tablete, 665 mg/11,1 mg) EU/2/13/155/009 (1 x 6 tablet, 665 mg/11,1 mg) EU/2/13/155/010 (1 tableta, 1040 mg/17,4 mg) EU/2/13/155/011 (1 x 3 tablete, 1040 mg/17,4 mg) EU/2/13/155/012 (1 x 6 tablet, 1040 mg/17,4 mg) EU/2/13/155/013 (1 tableta, 1620 mg/27,0 mg) EU/2/13/155/014 (1 x 3 tablete, 1620 mg/27,0 mg) EU/2/13/155/015 (1 x 6 tablet, 1620 mg/27,0 mg)
English: In addition, in studies containing only spinosad, AUC and Cmax values were higher in fed than fasted dogs and therefore it is recommended to treat dogs with food as this maximises the opportunity for fleas to ingest lethal amounts of spinosad.
Slovenian: Poleg tega so bile v študijah s samim spinosadom vrednosti AUC in Cmax višje pri nahranjenih psih kot pri teščih.
English: Trifexis 425 mg/7.1 mg spinosad 425 mg/milbemycin oxime 7.1 mg
Slovenian: Trifexis 425 mg/7,1 mg spinosad 425 mg/milbemicin oksim 7,1 mg
English: 6.5 Nature and composition of immediate packaging Blister packs (of 1, 3 or 6 chewable tablets) in a carton.
Slovenian: Pretisni omoti (z 1, s 3 ali 6 žvečljivimi tabletami) v kartonski škatli.
English: Trifexis 425 mg/7.1 mg tablets:
Slovenian: Trifexis 425 mg/7,1 mg tablete:
English: 4346 and 3 dimples
Slovenian: 4346 in 3 vdolbinice
English: 4336 and 5 dimples
Slovenian: 4336 in 5 vdolbinic
English: EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 tablets, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 tablets, 665 mg/11.1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 tablets, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 tablets, 1040 mg/17.4 mg) EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg) EU/2/13/155/014 (1 x 3 tablets, 1620 mg/27.0 mg) EU/2/13/155/015 (1 x 6 tablets, 1620 mg/27.0 mg)
Slovenian: EU/2/13/155/008 (1 x 3 tablete, 665 mg/11,1 mg) EU/2/13/155/009 (1 x 6 tablet, 665 mg/11,1 mg) EU/2/13/155/010 (1 tableta, 1040 mg/17,4 mg) EU/2/13/155/011 (1 x 3 tablete, 1040 mg/17,4 mg) EU/2/13/155/012 (1 x 6 tablet, 1040 mg/17,4 mg) EU/2/13/155/013 (1 tableta, 1620 mg/27,0 mg) EU/2/13/155/014 (1 x 3 tablete, 1620 mg/27,0 mg) EU/2/13/155/015 (1 x 6 tablet, 1620 mg/27,0 mg)
English: Heartworm prevention treatment should be continued monthly, with the last administration being given one month after the dog has left the region, but not for more than 6 consecutive months using Trifexis in any one year.
Slovenian: Preprečevanje okužb s srčno glisto se mora nadaljevati mesečno in pes naj dobi zadnji odmerek en mesec po odhodu z zadevnega območja, vendar naj zdravljenje z zdravilom Trifexis ne traja več kot 6 zaporednih mesecev v enem letu.
English: Trifexis 270 mg/4.5 mg spinosad 270 mg/milbemycin oxime 4.5 mg
Slovenian: Trifexis 270 mg/4,5 mg spinosad 270 mg/milbemicin oksim 4,5 mg
English: Trifexis 270 mg/4.5 mg tablets:
Slovenian: Trifexis 270 mg/4,5 mg tablete:
English: In another study, after repeated oral administration of 70 mg spinosad and 1.18 mg milbemycin oxime/kg bodyweight to fed juvenile dogs for twelve consecutive months, steady state for systemic exposure (AUC) was reached by month 7.
Slovenian: V drugi študiji je po ponavljajoči se peroralni uporabi 70 mg spinosada in 1,18 mg milbemicin oksima/kg telesne mase, ki so ju mladi psi prejemali po obroku dvanajst zaporednih mesecev, bilo stanje dinamičnega ravnovesja za sistemsko izpostavljenost (AUC) doseženo do 7. meseca.
English: In another study, after repeated monthly oral administration of 70 mg spinosad and 1.18 mg milbemycin oxime/kg bodyweight to fed adult dogs for twelve consecutive months, steady state for systemic exposure (AUC) was reached in month 3.
Slovenian: V drugi študiji je po ponavljajoči se mesečni peroralni uporabi 70 mg spinosada in 1,18 mg milbemicin oksima/kg telesne mase, ki so ju odrasli psi prejemali po obroku dvanajst zaporednih mesecev, bilo stanje dinamičnega ravnovesja za sistemsko izpostavljenost (AUC) doseženo v 3. mesecu.
English: Faecal excretion accounted for the vast majority of metabolites in dogs.
Slovenian: Velika večina presnovkov se je pri psih izločila z blatom.
English: Vomiting was seen in both treated and control dogs with similar frequencies.
Slovenian: Pogostost bruhanja je bila podobna v zdravljeni in kontrolni skupini.
English: Trifexis 270 mg/4.5 mg chewable tablets for dogs (3.9 - 6.0 kg) Trifexis 425 mg/7.1 mg chewable tablets for dogs (6.1 - 9.4 kg) Trifexis 665 mg/11.1 mg chewable tablets for dogs (9.5 - 14.7 kg) Trifexis 1040 mg/17.4 mg chewable tablets for dogs (14.8 - 23.1 kg) Trifexis 1620 mg/27 mg chewable tablets for dogs (23.2 - 36.0 kg)
Slovenian: Trifexis 270 mg/4,5 mg žvečljive tablete za pse (3,9 - 6,0 kg) Trifexis 425 mg/7,1 mg žvečljive tablete za pse (6,1 - 9,4 kg) Trifexis 665 mg/11,1 mg žvečljive tablete za pse (9,5 - 14,7 kg) Trifexis 1040 mg/17,4 mg žvečljive tablete za pse (14,8 - 23,1 kg) Trifexis 1620 mg/27 mg žvečljive tablete za pse (23,2 - 36,0 kg)
English: Trifexis 270 mg/4.5 mg for dogs (3.9 - 6.0 kg) Trifexis 425 mg/7.1 mg for dogs (6.1 - 9.4 kg) Trifexis 665 mg/11.1 mg for dogs (9.5 - 14.7 kg) Trifexis 1040 mg/17.4 mg for dogs (14.8 - 23.1 kg) Trifexis 1620 mg/27 mg for dogs (23.2 - 36.0 kg)
Slovenian: Trifexis 270 mg/4,5 mg za pse (3,9-6,0 kg) Trifexis 425 mg/7,1 mg za pse (6,1-9,4 kg) Trifexis 665 mg/11,1 mg za pse (9,5-14,7 kg) Trifexis 1040 mg/17,4 mg za pse (14,8-23,1 kg) Trifexis 1620 mg/27 mg za pse (23,2-36,0 kg)
English: PACKAGE LEAFLET FOR: Trifexis 270 mg/4.5 mg chewable tablets for dogs Trifexis 425 mg/7.1 mg chewable tablets for dogs Trifexis 665 mg/11.1 mg chewable tablets for dogs Trifexis 1040 mg/17.4 mg chewable tablets for dogs Trifexis 1620 mg/27 mg chewable tablets for dogs
Slovenian: NAVODILO ZA UPORABO Trifexis 270 mg/4,5 mg žvečljive tablete za pse Trifexis 425 mg/7,1 mg žvečljive tablete za pse Trifexis 665 mg/11,1 mg žvečljive tablete za pse Trifexis 1040 mg/17,4 mg žvečljive tablete za pse Trifexis 1620 mg/27 mg žvečljive tablete za pse
English: It is recommended that lungworm prevention should be continued until at least 1 month after the last exposure to slugs and snails, but not for more than 6 consecutive months using Trifexis in any one year.
Slovenian: Priporočeno je, da se preprečevanje angiostrongiloze nadaljuje še najmanj en mesec po zadnji izpostavljenosti polžem, vendar ne več kot 6 zaporednih mesecev uporabe zdravila Trifexis v enem letu.
English: It is recommended that heartworm prevention treatment should be continued at regular monthly intervals until at least 1 month after the last exposure to mosquitoes, but not for more than 6 consecutive months using Trifexis in any one year.
Slovenian: Priporočeno je, da se preprečevanje okužb s srčno glisto nadaljuje v rednih mesečnih intervalih še najmanj en mesec po zadnji izpostavljenosti komarjem, vendar naj zdravljenje z zravilo Trifexis ne traja več kot 6 zaporednih mesecev v enem letu.
English: Neurotoxicity characterised by transient mild depression, ataxia, trembling, mydriasis, and excessive salivation has been observed in dogs given higher dose multiples of milbemycin oxime alone (5 to 10 mg/kg).
Slovenian: Pri psih, ki so dobili več večjih odmerkov samega milbemicin oksima (od 5 do 10 mg/kg), so opazili nevrotoksičnost z blago depresijo, ataksijo, tremorjem, midriazo in čezmerno salivacijo.
English: In pregnant and lactating dogs (bitches), the safety of this veterinary medicinal product has not been sufficiently established.
Slovenian: Varnost tega zdravila pri psicah v obdobju brejosti in laktacije ni zadostno ugotovljena.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Po uporabi si umijte roke.
English: Hypersalivation, muscle tremors, ataxia and seizures were uncommon.
Slovenian: Občasno so opazili prekomerno slinjenje, mišični tremor, ataksijo in konvulzije.
English: A single treatment is effective for the treatment of gastrointestinal nematodes.
Slovenian: Pri želodčno-črevesnih nematodih zadostuje že en cikel zdravljenja.
English: Date of first authorisation: 15 July 2016
Slovenian: Datum prve odobritve: 15. julij 2016
English: This will help get the best results for your health.
Slovenian: Tako boste dosegli najboljši izid za svoje zdravje.
English: - if you are 75 years old or older.
Slovenian: - če ste stari 75 let ali več.
English: (See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)
Slovenian: (Glejte poglavja 4.2, 4.4, 4.5 in 5.1 za podatke, ki so na voljo o raziskanih kombinacijah.)
English: < 8.0 % ≥ 8 % to < 9.0 % ≥ 9.0 %
Slovenian: < 8,0 % ≥ 8 % do < 9,0 % ≥ 9,0 %
English: Some symptoms need immediate medical attention:
Slovenian: Nekateri simptomi zahtevajo takojšnjo zdravniško pomoč:
English: What to do if you forget to take a tablet.
Slovenian: Kaj storiti, če pozabite vzeti tableto.
English: How much to take - The recommended dose is one tablet a day.
Slovenian: Koliko zdravila morate vzeti - Priporočeni odmerek je ena tableta na dan.
English: This will help you to remember to take it.
Slovenian: Tako si boste lažje zapomnili, da jo vzamete.
English: This is an antibiotic used to treat infections such as tuberculosis.
Slovenian: To je antibiotik, ki se uporablja za zdravljenje okužb, kot je tuberkuloza.
English: The safety and efficacy of this medicinal product in children and adolescents aged 0 to < 18 years have not yet been established.
Slovenian: Varnost in učinkovitost tega zdravila pri otrocih in mladostnikih v starosti od 0 do < 18 let še nista ugotovljeni.
English: The increased/decreased risk was not statistically significant in any of the organ systems.
Slovenian: Povečanje/zmanjšanje tveganja ni bilo statistično značilno v katerem koli od organskih sistemov.
English: Study CV181168
Slovenian: Študija CV181168
English: Your blood sugar may increase without this medicine.
Slovenian: Krvni sladkor se vam lahko brez tega zdravila zviša.
English: For more information, see section “Other medicines and Qtern” below.
Slovenian: Za več informacij glejte poglavje "Druga zdravila in zdravilo Qtern", spodaj.
English: Then take your next dose at the usual time.
Slovenian: Naslednji odmerek nato vzemite ob običajnem času.
English: Taking this medicine - Swallow the tablet whole with half a glass of water.
Slovenian: Jemanje tega zdravila - Tableto zaužijte celo s pol kozarca vode.
English: Fournier's gangrene has to be treated immediately.
Slovenian: Fournierjevo gangreno je treba takoj začeti zdraviti.
English: Such studies have been conducted with the individual active substances.
Slovenian: Takšne študije so izvedli z njegovima posameznima učinkovinama.
English: EU/1/16/1108/001 14 film-coated tablets EU/1/16/1108/002 28 film-coated tablets EU/1/16/1108/003 98 film-coated tablets EU/1/16/1108/004 30 film-coated tablets
Slovenian: EU/1/16/1108/001 14 filmsko obloženih tablet EU/1/16/1108/002 28 filmsko obloženih tablet EU/1/16/1108/003 98 filmsko obloženih tablet EU/1/16/1108/004 30 filmsko obloženih tablet
English: - if you have or have had a disease of the pancreas.
Slovenian: - če imate ali ste kdaj imeli bolezen pankreasa (trebušne slinavke).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Reproductive and developmental toxicity
Slovenian: Reprodukcijska in razvojna toksičnost
English: p-value <0.0001.
Slovenian: Vrednost p < 0,0001.
English: The efficacy and safety profile of Qtern in these patients has not been established.
Slovenian: Profil učinkovitosti in varnosti zdravila Qtern pri teh bolnikih ni ugotovljen.
English: - You can take your tablet with or without food.
Slovenian: - Tableto lahko vzamete s hrano ali brez nje.
English: This may be used to treat inflammation in different body parts and organs.
Slovenian: Uporablja se lahko za zdravljenje vnetij v različnih delih telesa in organih.
English: See section 4.4
Slovenian: Glejte poglavje 4.4
English: Monitoring of ketones is recommended in these patients.
Slovenian: Pri teh bolnikih se priporoča spremljanje ketonov.
English: Your doctor will advise you of the signs and symptoms of heart failure.
Slovenian: Zdravnik vas bo seznanil z znaki in simptomi srčnega popuščanja.
English: p-value=0.0166.
Slovenian: Vrednost p = 0,0166.
English: Additional analysis did not indicate a differential effect among NYHA classes.
Slovenian: Dodatna analiza ni pokazala različnega vpliva med razredi po NYHA.
English: • For renal function approaching moderate renal impairment, at least 2 to 4 times per year.
Slovenian: • Pri bolnikih, pri katerih se delovanje ledvic približuje zmerni okvari ledvic, vsaj 2- do 4-krat na leto.
English: Patients who completed the initial 24-week study period were eligible to enter a controlled 28-week long-term study extension (52 weeks).
Slovenian: Bolniki, ki so dokončali začetno 24-tedensko obdobje študije, so lahko vstopili v kontrolirano 28-tedensko dolgoročno podaljšanje študije (52 tednov).
English: The AUC values of 5-OH-saxagliptin were also increased.
Slovenian: Višje so bile tudi vrednosti AUC 5-OH-saksagliptina.
English: The numerical imbalance of breast, bladder and prostate tumours must be considered with caution; it will be further investigated in post-authorisation studies.
Slovenian: Številsko neravnovesje tumorjev dojke, sečnega mehurja in prostate je treba interpretirati previdno; dodatno jih bodo raziskali v študijah po odobritvi zdravila.
English: Your doctor may prescribe other medicines to lower the amount of sugar in your blood.
Slovenian: Zdravnik vam bo morda predpisal še druga zdravila za znižanje sladkorja v krvi.
English: Difference in HbA1c effect
Slovenian: Razlika v učinku HbA1c
English: - Ketoconazole.
Slovenian: - ketokonazol.
English: What Qtern is and what it is used for
Slovenian: Kaj je zdravilo Qtern in za kaj ga uporabljamo
English: Efficacy parameter
Slovenian: Parameter učinkovitosti
English: The majority of patients in this study had a baseline HbA1c of > 8 % (see table 3).
Slovenian: Večina bolnikov v tej študiji je imela izhodiščni HbA1c > 8 % (glejte preglednico 3).
English: Especially tell your doctor: - if you are taking a medicine used to increase the amount of water you pass out of the body (diuretic).
Slovenian: Še zlasti morate zdravniku povedati: - če jemljete kakšno zdravilo, ki se uporablja za povečanje odvajanja vode iz telesa (diuretik).
English: No benefit was observed for MACE or all-cause mortality.
Slovenian: Opažali niso nobene koristi glede MACE ali umrljivosti zaradi vseh vzrokov.
English: There is no restriction based solely on age.
Slovenian: Omejitev za uporabo samo glede na starost ni.
English: Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.
Slovenian: Kot pri vseh bolnikih s sladkorno boleznijo je pomembno, da si redno pregledujete stopala in upoštevate ostale nasvete o negi stopal, ki ste jih prejeli od zdravstvenega delavca.
English: Frequencies of all uncommon adverse reactions were based on the individual mono-components data.
Slovenian: Pogostnosti vseh občasnih neželenih učinkov so temeljile na podatkih o posameznih učinkovinah.
English: These pharmacokinetic effects are not clinically meaningful and do not require dose adjustment.
Slovenian: Ti farmakokinetični učinki niso klinično pomembni in ne zahtevajo prilagoditve odmerka.
English: Frequency categories were defined according to very common (≥ 1/10), common (≥ 1/100 to ˂ 1/10), uncommon (≥ 1/1000 to ˂ 1/100), rare ( 1/10,000 to < 1/1000) and not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni  1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000) in neznana pogostnost (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
English: Treatment with dapagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised.
Slovenian: Zdravljenje z dapagliflozinom je mogoče znova uvesti, ko so vrednosti ketonov normalne in se bolnikovo stanje stabilizira.
English: The volume of distribution of saxagliptin was 205 l.
Slovenian: Volumen porazdelitve saksagliptina je bil 205 l.