FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejopri več kot 1 od 10 zdravljenih) - pogosti (pri več kot 1 toda manj kot pri 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1 toda manj kot pri 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1 toda manj kot pri 10 živalih od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina, ki je v osnovi biološkega izvora namenjena vzbujanju aktivne imunosti, ne spadajo v področje uporabe Uredbe(ES) št.470/2009.
English: Squalane Poloxamer 401 Polysorbate 80
Slovenian: Skvalan Poloksamer 401 Polisorbat 80
English: 0.2 mg *Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
Slovenian: * Relativna Potenca enote določena s količino ELISA antigena (in vitro test potence) v primerjavi z referenčnim cepivom.
English: The area of local tissue reactions is in general below 2 cm in diameter.
Slovenian: Področje lokalne tkivne reakcije je ponavadi manjše od 2 cm v premeru.
English: Zoetis WHC 2 LLC 2000 Rockford Road, Charles City IA 50616 USA
Slovenian: 2000 Rockford Road, Charles City IA 50616 ZDA
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.
English: Local tissue reactions in the form of swelling at the injection site, which may be associated with local heat, redness and pain at palpation, are very common and may last for up to 2 days (based on laboratory safety studies).
Slovenian: Zelo pogosta je lokalna reakcija tkiva v obliki otekline na mestu injiciranja, ki je lahko povezana z lokalno toploto, rdečino in bolečino na otip, ki lahko traja do 2 dni (osnovano na laboratorijskih varnostnih študijah).
English: Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting, diarrhea or depression.
Slovenian: Takoj po cepljenju se lahko pojavijo blage reakcije, podobne preobčutljivostnim reakcijam, ki se kažejo s prehodnimi kliničnimi znaki kot so bruhanje, driska ali depresija.
English: During Storage, a slight black deposit may appear and the emulsion may separate into two distinct phases.
Slovenian: Med shranjevanjem se lahko pojavi rahla črna usedlina in emulzija se lahko razsloji v dve fazi.
English: Name and address of the manufacturer of the biological active substance(s)
Slovenian: Ime in naslov proizvajalca proizvajalcevbiološke(bioloških) učinkovine (učinkovin)
English: 125 doses
Slovenian: 125 odmerkov
English: EU/2/15/190/001 EU/2/15/190/002 EU/2/15/190/003 EU/2/15/190/004 EU/2/15/190/005 EU/2/15/190/006
Slovenian: EU/2/15/190/002 EU/2/15/190/003 EU/2/15/190/004 EU/2/15/190/005
English: 10 x 25 doses 10 x 50 doses 4 x 125 doses
Slovenian: 10 x 25 odmerkov 10 x 50 odmerkov 4 x 125 odmerkov
English: Inactivated Mycoplasma hyopneumoniae, strain P-5722-3
Slovenian: Inaktivirana Mycoplasma hyopneumoniae, sev P-5722-3
English: Shelf life of the veterinary medicinal product as package for sale: 18months.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 18 mesecev
English: Administer one dose of 2 ml to pigs in the neck behind the ear.
Slovenian: Odmerek po 2 ml aplicirajte pujsku v vrat za uho.
English: Pigs (for fattening).
Slovenian: Prašiči (pitanci).
English: No information is available on the safety of this vaccine in breeding boars.
Slovenian: Informacije o varnosti uporabe cepiva pri plemenskih merjascih niso na voljo.
English: Special warnings for use in animals: Vaccinate only healthy animals.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Cepite samo zdrave živali.
English: High density polyethylene vials of 50 ml, of 100 ml and of 250 ml (25, 50 and 125 doses), with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Slovenian: Viale iz polietilena visoke gostote: 50 ml, 100 ml in 250 ml (s po 25, 50 ali 125 odmerki), z elastomernim zamaškom iz klorbutila, zaščitenim z aluminijasto kapico.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGIH SNOVI
English: In a laboratory study, a post-mortem examination of the injection site, performed 4 weeks after the administration of a single dose of the vaccine, revealed a mild inflammatory response, as evidenced by the absence of tissue necrosis and little fibrosis.
Slovenian: V kliničnih študijah je post-mortem pregled mesta injiciranja 4 tednov po aplikaciji enega odmerka cepiva pokazal blago vnetje z nekrozo tkiva in manjšimi fibrozami.
English: In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2°C.
Slovenian: Pri posameznih prašičih lahko telesna temperatura, v primerjavi s tisto pred cepljenjem, naraste za 2°C).
English: Suvaxyn Circo+MH RTU emulsion for injection for pigs
Slovenian: NAVODILO ZA UPORABO Suvaxyn Circo+MH RTU emulzija za injiciranje za prašiče
English: Duration of immunity: 23 weeks after vaccination.
Slovenian: Trajanje imunosti: 23 tednov po cepljenju .
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALECZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
English: Emulsion for injection
Slovenian: emulzija za injiciranje
English: 25 doses 50 doses
Slovenian: 25 odmerkov 50 odmerkov
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Slovenian: A. PROIZVAJALEC(PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE
English: Thiomersal Squalane Poloxamer 401 Polysorbate 80 Monobasic potassium phosphate anhydrous Sodium chloride Potassium chloride Disodium phosphate anhydrous Sodium phosphate dibasic heptahydrate Disodium tetraborate decahydrate EDTA tetrasodium Water for injections
Slovenian: Natrijev hidrogenfosfat, brezvodni Natrijev hidrogenfosfat, heptahidrat Dinatrijev tetraborat dekahidrat Tetranatrijev EDTA
English: Pharmacotherapeutic group: immunologicals for Suidae, inactivated viral and inactivated bacterial vaccines for pigs.
Slovenian: Inaktivirana virusna in inaktivirana bakterijska cepiva za prašiče.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC(PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) INPROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: For active immunization of pigs from the age of 3 weeks against Mycoplasma hyopneumoniae to reduce lung lesions caused by infection with M. hyopneumoniae.
Slovenian: Za aktivno imunizacijo prašičev, starejših od 3 tednov, proti Mycoplasma hyopneumoniae, s čimer se zmanjša poškodbe pljuč, ki jih povzroči okužba z Mycoplasma hyopneumoniae.
English: PACKAGE LEAFLET: Suvaxyn Circo+MH RTU emulsion for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Suvaxyn Circo+MH RTU emulzija za injiciranje za prašiče
English: For active immunisation of pigs from 3 weeks of age against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
Slovenian: Aktivna imunizacija prašičev, starejših od 3 tednov, proti prašičjemu cirkovirusu tipa 2 (PCV2) za zmanjšanje kopičenja virusa v krvi in limfoidnem tkivu in širjenja z iztrebki, povezanih z infekcijo z
English: Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 3 weeks of age.
Slovenian: Enkratno intramuskularno injekcijo odmerka po 2 ml aplicirajte pujsku v vrat za uho od 3. tedna starosti.
English: A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2-fold overdose.
Slovenian: 4 ure po dvakratnem prekomernem odmerjanju se je pojavilo prehodno povečanje telesne temperature (v povprečju za 0,8°C).
English: In the case of accidental self-injection, 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 nenamerne(ga) samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL)
English: It is intended to stimulate active immunity against PCV2 and Mycoplasma hyopneumoniae in pigs.
Slovenian: Namenjeno je aktivni imunizaciji prašičev, proti prašičjemu cirkovirusu tipa 2 (PCV2) in proti Mycoplasio hyopneumoniae.
English: EU/2/15/190/001-006.
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/15/190/001-006.
English: Cardboard box of 1 vial of 50 ml (25 doses), 100 ml (50 doses) or 250 ml (125 doses).
Slovenian: Kartonska škatla z 1 vialo s 25 odmerki (50 ml), 50 odmerki (100ml) ali 125 odmerki (250 ml).
English: Cardboard box of 4 vials of 250 ml (125 doses).
Slovenian: Kartonska škatla s 4 vialami s 125 odmerki (250 ml).
English: Cardboard box of 10 vials of 50 ml (25 doses) or 100 ml (50 doses).
Slovenian: Kartonska škatla z 10 vialami s 25 odmerki (50 ml), 50 odmerki (100ml).
English: Withdrawal period(s): Zero days.
Slovenian: Karenca: 0 dni.
English: IM
Slovenian: Skvalan
English: The vaccine contains an inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein.
Slovenian: Cepivo vsebuje inaktiviran rekombinanten prašičji cirko virus tip I z izraženim proteinom ORF2
English: Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Slovenian: Inaktiviran rekombinanten prašičji cirko virus tip I z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS HDPE vials (25 or 50 doses)
Slovenian: HDPE viale (25 ali 50 odmerkov)
English: 4.4 Special warnings for each target species
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Informacije o varnosti uporabe cepiva pri plemenskih merjascih niso na voljo.
English: QUANTITY OF THE ACTIVE SUBSTANCES
Slovenian: KOLIČINA UČINKOVIN(E)
English: The vaccine contains an inactivated recombinant chimeric Porcine Circovirus type 1 containing the Porcine Circovirus type 2 ORF2 protein and inactivated Mycoplasma hyopneumoniae.
Slovenian: prašičjega cirkovirusa tipa 2 in inktivirano Mycoplasmo hyopneumoniae.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Slovenian: Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem Ti ukrepi pomagajo varovati okolje.
English: What to do if you forget to take a tablet depends on how long it is until your next dose.
Slovenian: Kaj narediti, če pozabite vzeti tableto, je odvisno od tega, koliko časa je do naslednjega odmerka.
English: • about what you can do to prevent dehydration
Slovenian: • glede tega, kaj lahko naredite, da bi preprečili dehidracijo.
English: This effect was observed after 24 weeks and maintained for 76 weeks.
Slovenian: Ta učinek so opazili po 24 tednih in se je ohranil 76 tednov.
English: The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for the products listed in Annex A;
Slovenian: Odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 za zdravila, navedena v Prilogi A;
English: The safety and efficacy of empagliflozin in children and adolescents has not yet been established.
Slovenian: Varnost in učinkovitost empagliflozina pri otrocih in mladostnikih še nista bili dokazani.
English: Your doctor will decide whether to increase your dose to 25 mg once a day.
Slovenian: Vaš zdravnik se bo odločil, ali bo odmerek povečal na 25 mg enkrat na dan.
English: The PRAC therefore considered that the risk may constitute a possible class effect;
Slovenian: Odbor PRAC je zato menil, da je tveganje morda morebiten učinek razreda zdravil;
English: • excessive hunger, headache
Slovenian: • pretirana lakota, glavobol
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene kot zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥ 1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000) in zelo redki (<1/10.000) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Do not take Jardiance: - if you are allergic to empagliflozin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Jardiance: • če ste alergični na empagliflozin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • Your doctor may limit your dose to 10 mg once a day if you have a kidney problem.
Slovenian: • Vaš zdravnik bo morda odmerek omejil na 10 mg enkrat na dan, če imate težave z ledvicami.
English: If you note an increase in such symptoms, you should also contact your doctor.
Slovenian: Če se število teh simptomov poveča, se morate posvetovati z zdravnikom.
English: The efficacy for preventing cardiovascular mortality has not been conclusively established in users of DPP-4 inhibitors or in Black patients because the representation of these groups in the EMPA-REG OUTCOME study was limited.
Slovenian: Učinkovitost preprečevanja srčno-žilne umrljivosti niso neizpodbitno dokazali pri uporabnikih DPP-4 zaviralcev ali temnopoltih bolnikih, ker je bila zastopanost teh skupin v študiji EMPA-REG OUTCOME omejena.
English: For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Slovenian: Za rezultate študij glede kombiniranega zdravljenja, učinka na urejenost glikemije in kardiovaskularne dogodke ter proučevano populacijo, glejte poglavja 4.4, 4.5 in 5.1.
English: see section 4.4
Slovenian: * glejte poglavje 4.4
English: Other medicines and Jardiance
Slovenian: Druga zdravila in zdravilo Jardiance
English: The PRAC was also of the opinion that a mechanism of action, allowing to understand which patients are at risk, is still unclear;
Slovenian: Odbor PRAC je prav tako menil, da mehanizem delovanja, ki bi omogočil razumevanje, kateri bolniki so ogroženi, še ni jasen;
English: Because no specific risk factors could be identified apart from general amputation risk factors potentially contributing to the events, the PRAC recommended that patients should be advised on routine preventative foot care and maintaining adequate hydration as a general advice to prevent amputation;
Slovenian: Ker poleg splošnih dejavnikov tveganja za amputacijo ni bilo mogoče določiti specifičnih dejavnikov tveganja, ki bi prispevali k dogodkom, je odbor PRAC priporočil, da je treba bolnikom svetovati rutinsko preventivno nego stopal in vzdrževanje primerne hidratacije kot splošen nasvet za preprečevanje amputacije;
English: • Jardiance can also be used with other medicines for the treatment of diabetes.
Slovenian: • Zdravilo Jardiance se lahko uporablja tudi z drugimi zdravili za zdravljenje sladkorne bolezni.
English: Five studies had treatment durations of 24 weeks; extensions of those and other studies had patients exposed to empagliflozin for up to 102 weeks.
Slovenian: V petih študijah je zdravljenje trajalo 24 tednov; v podaljških teh in drugih študij so bili bolniki empagliflozinu izpostavljeni do 102. tedna.
English: An urge to pass urine or more frequent urination may be due to the way Jardiance works, but they can also be signs of urinary tract infection.
Slovenian: Znaki siljenja na uriniranje ali pogostejše uriniranje so lahko tudi posledica načina delovanja zdravila Jardiance, vendar so lahko tudi znak okužbe sečil.
English: By blocking this protein, the medicine causes glucose (blood sugar), sodium (salt) and water to be removed via the urine.
Slovenian: Z zaviranjem te beljakovine zdravilo povzroča izločanje glukoze (krvnega sladkorja), natrija (soli) in vode prek urina.
English: These may be medicines taken by mouth or given by injection such as insulin.
Slovenian: Ta zdravila se lahko jemljejo peroralno ali pa jih injiciramo, kot na primer insulin.
English: The PRAC was therefore of the view that the risk of lower limb amputation should be included in the product information for all products listed in Annex A, with a warning highlighting to healthcare professional and patients the importance of routine preventative foot care.
Slovenian: Odbor PRAC je torej menil, da je treba tveganje za amputacijo spodnjih okončin vključiti v informacije o zdravilu za vsa zdravila, navedena v Prilogi A, z opozorilom za zdravstvene delavce in bolnike o pomenu rutinske preventivne nege stopal.
English: No Met mg mg
Slovenian: Brez Met mg mg
English: The glucosuria observed with empagliflozin is accompanied by diuresis which may contribute to sustained and moderate reduction of blood pressure.
Slovenian: Glukozurijo, ki so jo opazili pri empagliflozinu, spremlja diureza, ki lahko prispeva k trajnemu in zmernemu znižanju krvnega tlaka.
English: • blood tests may show changes in blood fat (cholesterol) levels in your blood
Slovenian: • krvni testi lahko pokažejo spremembe ravni maščob v krvi (holesterol)
English: Initial increases in creatinine and initial decreases in estimated glomerular filtration rates in patients treated with empagliflozin were generally transient during continuous treatment or reversible after drug discontinuation of treatment.
Slovenian: Začetna zvišanja ravni kreatinina in začetna zmanjšanja predvidene hitrosti glomerularne filtracije pri bolnikih, zdravljenih z empagliflozinom, so bila praviloma prehodna med neprekinjenim zdravljenjem ali reverzibilna po prenehanju zdravljenja.
English: The reduction of cardiovascular death was comparable for empagliflozin 10 mg and 25 mg (Figure 1) and confirmed by an improved overall survival (Table 10).
Slovenian: Znižanje srčno-žilne smrtnosti je bilo primerljivo za empagliflozin 10 mg in 25 mg (slika 1) in dokazano z izboljšanjem celokupnega preživetja (preglednica 10).
English: In 6 placebo-controlled trials of 18 to 24 weeks duration, 3,534 patients were included of which 1,183 were treated with placebo and 2,351 with empagliflozin.
Slovenian: V 6 s placebom nadzorovanih preskušanjih, ki so trajala 18 do 24 tednov, je bilo vključenih 3.534 bolnikov, od katerih jih je 1.183 prejemalo placebo, 2.351 pa empagliflozin.
English: What you need to know before you take Jardiance
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Jardiance
English: The PRAC also considered that additional information on amputation events should be collected through appropriate case report forms (CRFs) for clinical trials, follow-up questionnaires for postmarketing cases, use of common MedDRA preferred term (PT) lists for amputation preceding events, and appropriate meta-analyses of large studies including cardiovascular outcome studies.
Slovenian: Odbor PRAC je menil tudi, da je treba zbrati dodatne informacije o amputacijah, in sicer z ustreznimi obrazci za poročila o primerih v kliničnih preskušanjih, vprašalniki za spremljanje primerov v obdobju trženja, uporabo seznamov prednostnih izrazov MedDRA za znake, ki napovedujejo amputacijo, in ustreznimi metaanalizami velikih študij, vključno s študijami kardiovaskularnih izidov.
English: Blood glucose levels, which are too high because of your type 2 diabetes, are thereby reduced.
Slovenian: Raven glukoze v krvi, ki je previsoka zaradi sladkorne bolezni tipa 2, se s tem zmanjša.
English: The PRAC considered that the available data on amputation in the CANVAS and CANVAS-R trials confirm that treatment with canagliflozin may contribute to an increased risk of amputation of the lower limb, mainly of the toe;
Slovenian: Odbor PRAC je menil, da razpoložljivi podatki o amputacijah iz preskušanj CANVAS in CANVAS-R potrjujejo, da zdravljenje s kanagliflozinom lahko prispeva k povečanemu tveganju za amputacijo spodnjih okončin, predvsem prstov;
English: If you forget to take Jardiance
Slovenian: Če ste pozabili vzeti zdravilo Jardiance
English: 2-hour post-prandial glucose
Slovenian: Vrednost glukoze 2 uri po jedi
English: Other side effects while taking Jardiance: Common
Slovenian: Drugi neželeni učinki, ki se lahko pojavijo med jemanjem zdravila Jardiance: Pogosti
English: Table 10:Treatment effect for the primary composite endpoint, its components and mortality Placebo
Slovenian: Preglednica 10: Učinek zdravljenja na primarni sestavljeni opazovani dogodek, njegovi sestavni deli in umrljivost placebo empagliflozin
English: • blood tests may show changes related to kidney function (creatinine or urea)
Slovenian: • krvni testi lahko pokažejo spremembe, povezane z delovanjem ledvic (kreatinin ali sečnina)
English: A total of 15,582 patients with type 2 diabetes were included in clinical studies to evaluate the safety of empagliflozin, of which 10,004 patients received empagliflozin, either alone or in combination with metformin, a sulphonylurea, pioglitazone, DPP-4 inhibitors, or insulin.
Slovenian: V klinične študije za ocenitev varnosti empagliflozina je bilo vključenih skupaj 15.582 bolnikov s sladkorno boleznijo tipa 2, od katerih je 10.004 bolnikov prejemalo empagliflozin samostojno ali v kombinaciji z metforminom, sulfonilsečnino, pioglitazonom, zaviralci DPP-4 ali insulinom.
English: In this analysis, AUC was estimated to be 5.82%, 10.4%, and 17.3% lower in subjects with BMI of 30, 35, and 45 kg/m2, respectively, compared to subjects with a body mass index of 25 kg/m
Slovenian: V tej analizi so ocenili, da je vrednost AUC 5,82 %, 10,4 % oz. 17,3 % nižja pri osebah z BMI 30, 35 oz. 45 kg/m2 v primerjavi z osebami z indeksom telesne mase 25 kg/m
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja tega zdravila in med zdravljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: These infections were reported more frequently in females treated with empagliflozin compared to placebo, and the difference in frequency was less pronounced in males.
Slovenian: O teh okužbah so pogosteje poročali pri ženskah, zdravljenih z empagliflozinom v primerjavi s placebom, razlika v pogostnosti pa je bila manj izrazita pri moških.
English: No dose adjustment is required for patients with hepatic impairment.
Slovenian: Prilagoditev odmerka pri bolnikih z jetrno okvaro ni potrebna.