natgillin/translations-raw huggingface dataset:
Victrelis in combination with peginterferon alfa and ribavirin can lead to a higher rate of anaemia (low red blood cell counts) than is seen in treatment with peginterferon and ribavirin alone. 
Zdravilo Victrelis lahko v kombinaciji s peginterferonom alfa in ribavirinom povzroča višjo stopnjo anemije (nizko število rdečih krvnih celic) v primerjavi z zdravljenjem samo s peginterferonom in ribavirinom.
The CHMP noted that Victrelis in combination with peginterferon alfa and ribavirin significantly increases the number of patients cured of chronic hepatitis C infection. 
CHMP je menil, da zdravilo Victrelis v kombinaciji s peginterferonom alfa in ribavirinom pomembno poveča število bolnikov, pri katerih je okužba s kroničnim hepatitisom C ozdravljena.
How does Victrelis work? 
Kako zdravilo Victrelis deluje?
Victrelis was effective at curing patients with chronic hepatitis C genotype 1 infection who were also treated with peginterferon alfa and ribavirin. 
Zdravilo Victrelis je bilo učinkovito pri zdravljenju bolnikov, okuženih s kroničnim hepatitisom C genotipa 1, ki so jih zdravili tudi s peginterferonom alfa in ribavirinom.
Victrelis is used to treat adults with chronic (long-term) hepatitis C genotype 1 (a disease of the liver due to infection with the hepatitis C virus) in combination with two other medicines, peginterferon alfa 
Zdravilo Victrelis se uporablja za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C genotipa 1 (boleznijo jeter zaradi okužbe z virusom hepatitisa C) v kombinaciji z dvema drugima zdraviloma, peginterferonom alfa in ribavirinom.
This was an important improvement on results seen with only peginterferon alfa and ribavirin together. 
To predstavlja pomembno izboljšanje v primerjavi z rezultati, opaženimi pri zdravljenju samo s peginterferonom alfa in ribavirinom.
The patients must first take peginterferon alfa and ribavirin for four weeks, after which they will add Victrelis to the treatment for up to 44 weeks, depending on several factors such as the patient's previous treatment and results of blood tests during treatment. 
Bolniki morajo najprej štiri tedne jemati peginterferon alfa in ribavirin, šele nato zdravljenju dodajo zdravilo Victrelis, ki ga jemljejo do 44 tednov.
The main increase in side effects seen when adding Victrelis to treatment was anaemia. 
Med neželenimi učinki, opaženimi pri dodajanju zdravila Victrelis k tej terapiji, se je najbolj povečalo število primerov anemije.
The marketing authorisation holders shall complete the below conditions, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled: 
Imetniki dovoljenja za promet z zdravilom izpolnijo spodnje pogoje v navedenem roku, pristojni organi pa zagotovijo, da je izpolnjeno naslednje:
The details of the visual reminder should be agreed at national level and be subject to a user test taking into account input from local patient representatives. 
O podrobnostih vizualnega opomnika se je treba dogovoriti na nacionalni ravni, in sicer jih je treba preskusiti z uporabniškim preskusom, pri čemer je treba upoštevati pripombe lokalnih predstavnikov bolnikov.
A visual reminder on the outer package to warn patient about the harm to unborn baby and the need for effective contraception when using the medicinal product should be implemented in all medicinal products containing substances related to valproate. 
Vizualni opomnik na zunanji ovojnini za opozorilo bolnici o škodi za nerojenega otroka in potrebi po učinkoviti kontracepciji pri uporabi zdravila je treba uvesti pri vseh zdravilih, ki vsebujejo valproatu sorodne snovi.
With regards to the studies abovementioned, the MAHs are strongly encouraged to collaborate and perform joint studies. 
V zvezi s prej omenjenimi študijami se imetnike dovoljenj za promet z zdravili močno spodbuja k sodelovanju in izvedbi skupnih študij.
These should be submitted to the National Competent Authorities: Within 1 month of the Commission decision. 
v enem mesecu po sklepu Komisije.
MAHs are encouraged to extend the ongoing drug utilisation study (DUS). 
Imetnike dovoljenj za promet z zdravili se spodbuja, da študijo o uporabi zdravila (DUS), ki še poteka, podaljšajo.
All MAHs should have in place a Risk management plan (RMP). 
Poleg tega morajo imeti vsi imetniki dovoljenj za promet z zdravili vzpostavljen načrt za obvladovanje tveganj:
The MAHs of medicinal products with substances related to valproate shall develop and submit educational materials according to agreed core elements. 
Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo oblikovati in predložiti izobraževalna gradiva v skladu z dogovorjenimi bistvenimi elementi.
The MAHs of medicinal products with substances related to valproate shall conduct a retrospective observational study to investigate the association between paternal exposure to valproate and the risk of congenital anomalies and neurodevelopmental disorders including autism in offspring. 
Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo izvesti retrospektivno opazovalno študijo za raziskavo povezave med očetovo izpostavljenostjo valproatu ter tveganjem prirojenih anomalij in motenj razvoja živčevja, vključno z avtizmom, pri potomcih.
The MAHs of medicinal products with substances related to valproate shall perform a drug utilisation study to assess the effectiveness of the new risk minimisation measures and to further characterise the prescribing patterns for valproate. 
Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo izvesti študijo o uporabi zdravila, da ocenijo učinkovitost novih ukrepov za zmanjševanje tveganj in nadaljnjo opredelitev vzorcev predpisovanja valproata.
These materials should ensure that prescriber are informed and the patients understand and acknowledge the risks associated with valproate in-utero exposure. 
Ta gradiva morajo zagotoviti, da so zdravniki, ki predpisujejo zdravilo, in bolnice poučeni ter razumejo tveganja, povezana z izpostavljenostjo valproatu v maternici, in potrjujejo seznanjenost z njimi.
The MAHs of medicinal products with substances related to valproate shall conduct a PASS preferably based on existing registries to further characterise the foetal anticonvulsant syndrome in children with valproate in utero exposure as compared to other anti-epileptic drugs. 
Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo - po možnosti na podlagi obstoječih evidenc - izvesti študijo PASS za nadaljnjo opredelitev antikonvulzivnega sindroma pri plodu pri otrocih, izpostavljenih valproatu in utero, v primerjavi z drugimi zdravili proti epilepsiji.
The MAHs of medicinal products with substances related to valproate shall conduct an observational study to evaluate and identify the best practices for switching of valproate in clinical practice. 
Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo izvesti opazovalno študijo, da ocenijo in odkrijejo dobre prakse prehoda z valproata na druga zdravila v klinični praksi.
The MAHs of medicinal products with substances related to valproate shall perform a survey among patients to assess knowledge of the patients with regards to PPP as well as receipt/use of educational materials. 
Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo med bolniki izvesti raziskavo, da ocenijo njihovo znanje in ravnanje glede prednostnih vzorcev predpisovanja ter prejem/uporabo neposrednih sporočil za bolnike in izobraževalnih gradiv.
The MAHs of medicinal products with substances related to valproate shall perform a survey among HCP to assess knowledge of HCP and behaviour with regard to PPP as well as receipt/use of DHPC and educational materials. 
Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo med zdravstvenimi delavci izvesti raziskavo, da ocenijo njihovo znanje in ravnanje glede prednostnih vzorcev predpisovanja ter prejem/uporabo neposrednih sporočil za zdravstvene delavce in izobraževalnih gradiv.
Each dose (2 ml) contains: 
En odmerek (2 ml) vsebuje:
6.2 Major incompatibilities 
6.2 Glavne Inkompatibilnosti
ATCvet code: QI09AL 
Oznaka ATC vet: QI09AL
Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation. 
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Vsakdo, ki namerava proizvajati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo , se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
Date of first authorization: 06/11/2015. 
Datum pridobitve dovoljenja za promet: 06/11/2015.
Incompatibilities: Do not mix with any other vaccine or immunological product. 
Inkompatibilnosti: Ne uporabljajte z ostalimi cepivi ali imunološkimi zdravili.
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
SPC dovoljenje snovi za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, ne spadajo v področje uporabe Uredbe (ES) št. 470/2009 kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
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). 
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).
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
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/.
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. 
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.
Squalane Poloxamer 401 Polysorbate 80 
Skvalan Poloksamer 401 Polisorbat 80
0.2 mg *Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine. 
* Relativna Potenca enote določena s količino ELISA antigena (in vitro test potence) v primerjavi z referenčnim cepivom.
The area of local tissue reactions is in general below 2 cm in diameter. 
Področje lokalne tkivne reakcije je ponavadi manjše od 2 cm v premeru.
Zoetis WHC 2 LLC 2000 Rockford Road, Charles City IA 50616 USA 
2000 Rockford Road, Charles City IA 50616 ZDA
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.
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). 
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).
Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting, diarrhea or depression. 
Takoj po cepljenju se lahko pojavijo blage reakcije, podobne preobčutljivostnim reakcijam, ki se kažejo s prehodnimi kliničnimi znaki kot so bruhanje, driska ali depresija.
During Storage, a slight black deposit may appear and the emulsion may separate into two distinct phases. 
Med shranjevanjem se lahko pojavi rahla črna usedlina in emulzija se lahko razsloji v dve fazi.
Name and address of the manufacturer of the biological active substance(s) 
Ime in naslov proizvajalca proizvajalcevbiološke(bioloških) učinkovine (učinkovin)
125 doses 
125 odmerkov
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 
EU/2/15/190/002 EU/2/15/190/003 EU/2/15/190/004 EU/2/15/190/005
10 x 25 doses 10 x 50 doses 4 x 125 doses 
10 x 25 odmerkov 10 x 50 odmerkov 4 x 125 odmerkov
Inactivated Mycoplasma hyopneumoniae, strain P-5722-3 
Inaktivirana Mycoplasma hyopneumoniae, sev P-5722-3
Shelf life of the veterinary medicinal product as package for sale: 18months. 
Rok uporabnosti zdravila v pakiranju za prodajo: 18 mesecev
Administer one dose of 2 ml to pigs in the neck behind the ear. 
Odmerek po 2 ml aplicirajte pujsku v vrat za uho.
Pigs (for fattening). 
Prašiči (pitanci).
No information is available on the safety of this vaccine in breeding boars. 
Informacije o varnosti uporabe cepiva pri plemenskih merjascih niso na voljo.
Special warnings for use in animals: Vaccinate only healthy animals. 
Posebni previdnostni ukrepi za uporabo pri živalih Cepite samo zdrave živali.
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. 
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.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 
NAVEDBA UČINKOVIN(E) IN DRUGIH SNOVI
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. 
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.
In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2°C. 
Pri posameznih prašičih lahko telesna temperatura, v primerjavi s tisto pred cepljenjem, naraste za 2°C).
Suvaxyn Circo+MH RTU emulsion for injection for pigs 
NAVODILO ZA UPORABO Suvaxyn Circo+MH RTU emulzija za injiciranje za prašiče
Duration of immunity: 23 weeks after vaccination. 
Trajanje imunosti: 23 tednov po cepljenju .
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALECZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
Emulsion for injection 
emulzija za injiciranje
25 doses 50 doses 
25 odmerkov 50 odmerkov
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
A. PROIZVAJALEC(PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE
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 
Natrijev hidrogenfosfat, brezvodni Natrijev hidrogenfosfat, heptahidrat Dinatrijev tetraborat dekahidrat Tetranatrijev EDTA
Pharmacotherapeutic group: immunologicals for Suidae, inactivated viral and inactivated bacterial vaccines for pigs. 
Inaktivirana virusna in inaktivirana bakterijska cepiva za prašiče.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC(PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) INPROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
For active immunization of pigs from the age of 3 weeks against Mycoplasma hyopneumoniae to reduce lung lesions caused by infection with M. hyopneumoniae. 
Za aktivno imunizacijo prašičev, starejših od 3 tednov, proti Mycoplasma hyopneumoniae, s čimer se zmanjša poškodbe pljuč, ki jih povzroči okužba z Mycoplasma hyopneumoniae.
PACKAGE LEAFLET: Suvaxyn Circo+MH RTU emulsion for injection for pigs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Suvaxyn Circo+MH RTU emulzija za injiciranje za prašiče
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. 
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
Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 3 weeks of age. 
Enkratno intramuskularno injekcijo odmerka po 2 ml aplicirajte pujsku v vrat za uho od 3. tedna starosti.
A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2-fold overdose. 
4 ure po dvakratnem prekomernem odmerjanju se je pojavilo prehodno povečanje telesne temperature (v povprečju za 0,8°C).
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 
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.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL)
It is intended to stimulate active immunity against PCV2 and Mycoplasma hyopneumoniae in pigs. 
Namenjeno je aktivni imunizaciji prašičev, proti prašičjemu cirkovirusu tipa 2 (PCV2) in proti Mycoplasio hyopneumoniae.
EU/2/15/190/001-006. 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/15/190/001-006.
Cardboard box of 1 vial of 50 ml (25 doses), 100 ml (50 doses) or 250 ml (125 doses). 
Kartonska škatla z 1 vialo s 25 odmerki (50 ml), 50 odmerki (100ml) ali 125 odmerki (250 ml).
Cardboard box of 4 vials of 250 ml (125 doses). 
Kartonska škatla s 4 vialami s 125 odmerki (250 ml).
Cardboard box of 10 vials of 50 ml (25 doses) or 100 ml (50 doses). 
Kartonska škatla z 10 vialami s 25 odmerki (50 ml), 50 odmerki (100ml).
Withdrawal period(s): Zero days. 
Karenca: 0 dni.
IM 
Skvalan
The vaccine contains an inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein. 
Cepivo vsebuje inaktiviran rekombinanten prašičji cirko virus tip I z izraženim proteinom ORF2
Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein 
Inaktiviran rekombinanten prašičji cirko virus tip I z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS HDPE vials (25 or 50 doses) 
HDPE viale (25 ali 50 odmerkov)
4.4 Special warnings for each target species 
4.4 Posebna opozorila za vsako ciljno živalsko vrsto Informacije o varnosti uporabe cepiva pri plemenskih merjascih niso na voljo.
QUANTITY OF THE ACTIVE SUBSTANCES 
KOLIČINA UČINKOVIN(E)
The vaccine contains an inactivated recombinant chimeric Porcine Circovirus type 1 containing the Porcine Circovirus type 2 ORF2 protein and inactivated Mycoplasma hyopneumoniae. 
prašičjega cirkovirusa tipa 2 in inktivirano Mycoplasmo hyopneumoniae.
Ask your veterinary surgeon how to dispose of medicines no longer required. 
Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem Ti ukrepi pomagajo varovati okolje.
What to do if you forget to take a tablet depends on how long it is until your next dose. 
Kaj narediti, če pozabite vzeti tableto, je odvisno od tega, koliko časa je do naslednjega odmerka.
• about what you can do to prevent dehydration 
• glede tega, kaj lahko naredite, da bi preprečili dehidracijo.
This effect was observed after 24 weeks and maintained for 76 weeks. 
Ta učinek so opazili po 24 tednih in se je ohranil 76 tednov.
The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for the products listed in Annex A; 
Odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 za zdravila, navedena v Prilogi A;
The safety and efficacy of empagliflozin in children and adolescents has not yet been established. 
Varnost in učinkovitost empagliflozina pri otrocih in mladostnikih še nista bili dokazani.
Your doctor will decide whether to increase your dose to 25 mg once a day. 
Vaš zdravnik se bo odločil, ali bo odmerek povečal na 25 mg enkrat na dan.
The PRAC therefore considered that the risk may constitute a possible class effect; 
Odbor PRAC je zato menil, da je tveganje morda morebiten učinek razreda zdravil;
• excessive hunger, headache 
• pretirana lakota, glavobol
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). 
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).
Do not take Jardiance: - if you are allergic to empagliflozin or any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila Jardiance: • če ste alergični na empagliflozin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• Your doctor may limit your dose to 10 mg once a day if you have a kidney problem. 
• Vaš zdravnik bo morda odmerek omejil na 10 mg enkrat na dan, če imate težave z ledvicami.
If you note an increase in such symptoms, you should also contact your doctor. 
Če se število teh simptomov poveča, se morate posvetovati z zdravnikom.
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. 
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.
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. 
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.
see section 4.4 
* glejte poglavje 4.4
Other medicines and Jardiance 
Druga zdravila in zdravilo Jardiance
The PRAC was also of the opinion that a mechanism of action, allowing to understand which patients are at risk, is still unclear; 
Odbor PRAC je prav tako menil, da mehanizem delovanja, ki bi omogočil razumevanje, kateri bolniki so ogroženi, še ni jasen;