natgillin/translations-raw huggingface dataset:
14 F. J. Angulo et al., Evidence of an Association Between Use of Anti-microbial Agents in Food Animals and Antimicrobial Resistance Among Bacteria Isolated from Humans and the Human Health Consequences of Such Resistance, J. Vet. Med.. 51: 374 - 379 
F. J. Angulo et al., Evidence of an Association Between Use of Anti-microbial Agents in Food Animals and Antimicrobial Resistance Among Bacteria Isolated from Humans and the Human Health Consequences of Such Resistance (Dokazi o povezavi med uporabo protimikrobnih sredstev pri živalih za proizvodnjo živil in odpornostjo proti protimikrobnim sredstvom pri bakterijah, izoliranih iz ljudi, ter posledice takšne odpornosti za zdravje ljudi.)
Shelf life after first opening the container: 3 months. 
Rok uporabnosti zdravila po prvemu odprtju vsebnika: 3 mesece.
Resistance to tetracyclines has also been reported in pig respiratory pathogens (A. pleuropneumoniae, S. suis,) and calf pathogens (Pasteurella spp) in some EU countries. 
V nekaterih državah EU so poročali tudi o odpornosti na tetracikline pri prašičjih respiratornih patogenih (A. pleuropneumoniae, S. suis,) in telečjih patogenih (Pasteurella spp).
Resistance to tetracyclines has also been reported in pig respiratory pathogens (A. pleuropneumoniae, S. suis) and calf pathogens (Pasteurella spp) in some EU countries. 
V nekaterih državah EU so poročali tudi o odpornosti na tetracikline pri prašičjih respiratornih patogenih (A. pleuropneumoniae, S. suis) in telečjih patogenih (Pasteurella spp).
Poultry Sci. 56, 452-458 (1977) 3 Migaki et al, Efficacy of doxycycline against experimental complicated chronic respiratory disease compared with commercially available water medicants in broilers Poultry Sci. 56, 1739 (1977) 4 Goren et al, Therapeutic efficacy of doxycycline hyclate in experimentaI Escherichia coli infection in broilers, The Vet 
Poultry Sci. 56, 1739 (1977) 4 Goren et al.: Therapeutic efficacy of doxycycline hyclate in experimentaI Escherichia coli infection in broilers.
In calves acute, sometimes fatal myocardial degeneration can occur following singe or multiple dosages. 
Pri teletih lahko pride po enem samem ali več odmerkih do akutne miokardialne degeneracije, včasih s smrtnim izidom.
Benefit Risk assessment 
Ocena razmerja med tveganji in koristmi
A pharmacokinetics study demonstrated that when Doxycyline 50% WSP was administered in drinking water to broilers at a dose of doxycycline hyclate of 25 mg/kg body weight/day for 5 days, a steady state plasma doxycycline concentration of 2 μg/ml was reached after 6 hours. 
Farmakokinetična študija je pokazala, da kadar brojlerji 5 dni s pitno vodo prejemajo zdravilo Doxycycline 50% WSP z odmerkom doksiciklinijevega hiklata 25 mg na kg telesne mase na dan, je po šestih urah dosežena stabilna plazemska koncentracija doksiciklina 2 μg/ml.
Pharmacovigilance data (summary of PSURs) from use of the product in pigs have been provided covering the past 5 years. 
Predloženi so bili farmakovigilančni podatki (povzetek z zadnjimi podatki dopolnjenih poročil o varnosti zdravila) o uporabi zdravila pri prašičih za zadnjih pet let.
Lactose 
Teleta
Steady state plasma levels for doxycycline ranged from 0.37 - 0.89 μg/ml (at 7 mg/kg body weight), 0.7 to 1.14 μg/ml (at 13 mg/kg body weight) and 1.62 to 3.18 μg/ml (at 26 mg/kg body weight). 
Pijpers, 1990, je koncentracijo doksiciklina v stanju dinamičnega ravnovesja po peroralni uporabi s krmo z odmerki 7, 13 in 26 mg na kg telesne mase določal dvakrat na dan. Plazemska koncentracija doksiciklina v stanju dinamičnega ravnovesja je bila med 0,37 in 0,89 μg/ml (pri odmerku 7 mg na kg telesne mase), med 0,7 in 1,14 μg/ml (pri odmerku 13 mg na kg telesne mase) ter med 1,62 in 3,18 μg/ml (pri odmerku 26 mg na kg telesne mase).
Limited clinical data were provided to support use of the product to treat pleuropneumonia caused by A. pleuropneumoniae, and no clinical or field data were provided to support use of doxycycline in the treatment of atrophic rhinitis or bronchopneumonia in pigs. 
Predloženi so bili omejeni klinični podatki v podporo uporabi zdravila pri zdravljenju plevropnevmonije, ki jo povzroča A. pleuropneumoniae, v podporo uporabi doksiciklina pri zdravljenju atrofičnega rinitisa in bronhopnevmonije pri prašičih pa niso bili predloženi nobeni klinični ali terenski podatki.
A study showed that Doxycyline hyclaat 50% was well tolerated when administered at the recommended dose of 5 mg doxycycline hyclate/kg body weight/ twice daily for twice the recommended duration (10 days). 
Študija je pokazala, da so živali dobro prenašale zdravilo Doxycycline hyclaat 50%, kadar so ga dajali s priporočenim odmerkom 5 mg doksiciklinijevega hiklata na kg telesne mase dvakrat na dan in v dvakratnem priporočenem trajanju (10 dni).
A pharmacokinetic and residues study showed that at a daily dose of 10 mg doxycycline hydrochloride/kg body weight, administered once daily via milk replacer for 5 days, Cmax was achieved within 2 - 3 days with a mean value of 2.2 to 2.5 μg/ml. 
Farmakokinetična študija in študija ostankov sta pokazali, da se je z dnevnim odmerkom 10 mg doksiciklinijevega hidroklorida na kg telesne mase, ki se je dajal 5 dni enkrat na dan z mlečnim nadomestkom, v dveh do treh dneh dosegla povprečna vrednost Cmax 2,2 do 2,5 μg/ml.
Pre-ruminant calves: - Bronchopneumonia and pleuropneumonia caused by Pasteurella spp., Streptococcus spp., Arcanobacterium pyogenes, Histophilus somni and Mycoplasma spp. 
Teleta pred nastopom prežvekovanja: - Bronhialna pljučnica in plevropnevmonija, ki ju povzročajo Pasteurella spp., Streptococcus spp., Arcanobacterium pyogenes, Histophilus somni in Mycoplasma spp.
A study investigated the safety of Doxycyline 50% WSP administered at dose rates of 0, 10, 50 and 150 mg doxycycline hyclate/kg body weight/day for 10 days. 
S študijo so preučevali varnost zdravila Doxycycline 50% WSP pri desetdnevni uporabi odmerkov 0, 10, 50 in 150 mg doksiciklinijevega hiklata na kg telesne mase na dan.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES Doxycycline hyclate 500 mg/g (equivalent to doxycycline 433 mg/g) 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Doksiciklinijev hiklat 500 mg/g (enakovredno 433 mg/g doksiciklina)
Mean plasma values of 0.44 ± 0.12 μg/ml after 3 days of medication with an average dose of 10 mg/kg body weight were found. 
Po 3 dneh zdravljenja s povprečnim odmerkom 10 mg/kg so ugotovili povprečne vrednosti v plazmi, ki so 0,44 ± 0,12 μg/ml.
• the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data; the CVMP has recommended the variation of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxycycline 50% WSP and associated names (see Annex I). 
CVMP je priporočil spremembo dovoljenj za promet z zdravilom Doxycycline 50% WSP in povezanimi imeni (glejte Prilogo I), katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Prilogi III.
Pigs: - Atrophic rhinitis caused by Pasteurella multocida and Bordetella bronchiseptica; - Bronchopneumonia caused by Pasteurella multocida, Streptococcus suis and Mycoplasma hyorhinis; - Pleuropneumonia caused by Actinobacillus pleuropneumoniae. 
Prašiči: - Atrofični rinitis, ki ga povzročata Pasteurella multocida in Bordetella bronchiseptica; - Bronhialna pljučnica, ki jo povzročajo Pasteurella multocida, Streptococcus suis in Mycoplasma hyorhinis; - Plevropnevmonija, ki jo povzroča Actinobacillus pleuropneumoniae.
There was no clear discrepancy between Member States in the dose regimen of 10 mg doxycycline hyclate/kg body weight for 3 to 5 days. 
Pri režimih odmerjanja z odmerkom 10 mg doksiciklinijevega hiklata na kg telesne mase 3 do 5 dni med državami članicami ni bilo očitnih neskladij.
Doxycycline inhibits bacteria, Mycoplasma, Chlamydia, Rickettsia, and certain Protozoa. 
Doksiciklin zavira bakterije, mikoplazme, klamidijo, rikecijo in nekatere protozoe.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally 
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Izpolni se na nacionalni ravni
calves. 
• karenci.
Pharmacovigilance data (summary of PSURs) from use of the product in calves were provided covering the past 5 years. 
Predloženi so bili farmakovigilančni podatki (povzetek z zadnjimi podatki dopolnjenih poročil o varnosti zdravila) o uporabi zdravila pri teletih za zadnjih pet let.
A pharmacokinetic and residues study showed that at a daily dose of 10 mg doxycycline hydrochloride/kg body weight, doxycycline reached a steady state concentration of 0.4 μg/ml within 3 days. 
Farmakokinetična študija in študija ostankov sta pokazali, da je bila z dnevnim odmerkom 10 mg doksiciklinijevega hidroklorida na kg telesne mase v roku treh dni dosežena koncentracija doksiciklina v stanju dinamičnega ravnovesja 0,4 μg/ml.
There have been no adverse events in chickens, including suspected lack of expected efficacy reports during this period. 
V tem obdobju pri piščancih ni bilo nobenih poročil o neželenih učinkih, vključno z domnevno manjšo učinkovitostjo od pričakovane.
25 mg doxycycline hyclate /kg body weight / day, corresponding to 50 mg of product per kg body weight, for 3-5 consecutive days. 
25 mg doksiciklinijevega hiklata /kg telesne mase/dan, ustreza 50 mg zdravila na kg telesne mase, 3-5 zaporednih dni.
Shelf life after first opening of the immediate packaging: 3 months. 
Rok uporabnosti zdravila po prvemu odprtju stične ovojnine: 3 mesece.
There have been no adverse events in pigs, including suspected lack of expected efficacy reports during this period. 
V tem obdobju pri prašičih ni bilo nobenih poročil o neželenih učinkih, vključno z domnevno manjšo učinkovitostjo od pričakovane.
haemolytica. 
Tijdschr.
Doxycycline hyclate 500 mg/g (equivalent to doxycycline 433 mg/g) 
Doksiciklinijev hiklat 500 mg/g (enakovredno 433 mg/g doksiciklina)
A study investigated the safety of Doxycyline 50% WSP administered at doses of 0, 25 and 75 mg doxycycline hyclate/kg body weight /day for 5 days. 
S študijo so preučevali varnost zdravila Doxycycline 50% WSP pri petdnevni uporabi odmerkov 0,25 in 75 mg doksiciklinijevega hiklata na kg telesne mase na dan.
Doxycycline hyclate: 500 mg (equivalent to 433 mg doxycycline) Excipients: 
Doksiciklinijev hiklat: 500 mg (enakovredno 433 mg doksiciklina)
Doxycycline hyclate 500 mg/g 
doksiciklinijev hiklat500 mg/g
Calves, pigs, chicken 
Teleta, prašiči, piščanci
10 mg doxycycline hyclate /kg body weight / day, corresponding to 20 mg of product per kg body weight, for 3-5 consecutive days. 
10 mg doksiciklinijevega hiklata /kg telesne mase/dan, ustreza 20 mg zdravila na kg telesne mase, 3-5 zaporednih dni.
Applicant/ Marketing Authorisation Holder 
Imetnik dovoljenja za promet
Treatment was considered to have been effective in 98% of calves treated with Ronaxan (n=361) compared to 85% of calves treated with reference antimicrobial products (n=174). 
Haemolytica, in sicer 4-6 dni z odmerkom 10 mg na kg telesne mase na dan. Zdravljenje je štelo za učinkovito pri 98 % telet, zdravljenih z zdravilom Ronaxan (n=361), v primerjavi s 85 % telet, ki so jih zdravili z
Water Soluble Powder Poultry (not for use in animals from which eggs are produced for human consumption) Calves 
Perutnina (ni dovoljeno za uporabo pri pticah nesnicah jajc za prehrano ljudi), teleta, prašiči
Water Soluble Powder Cattle (calves), swine, birds 
Govedo (teleta), prašiči, ptic
Doxycycline 50% Doxycycline hyclate 500 mg/g 
Doxycycline 50% Dopharma doksiciklinijev hiklat 500 mg/g
INN & Strength 
INN Jakost
There have been no adverse events in calves, including suspected lack of expected efficacy reports during this period. 
V tem obdobju pri teletih ni bilo nobenih poročil o neželenih učinkih, vključno z domnevno manjšo učinkovitostjo od pričakovane.
THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the reach and sight of children. 
BESEDILO „ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM“ Zdravilo shranjujte nedosegljivo otrokom.
• Bronchopneumonia caused by Pasteurella multocida, Streptococcus suis and Mycoplasma hyorhinis 
• Bronhopnevmonija, ki jo povzročajo Pasteurella multocida, Streptococcus suis in
Calves: 7 days 
Teleta pred nastopom prežvekovanja: 7 dni
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE PP Container 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Vsebnik iz polipropilena
TARGET SPECIES Pre-ruminant calves, pigs and chickens 
CILJNE ŽIVALSKE VRSTE Teleta pred nastopom prežvekovanja, prašiči in piščanci
In a study by Meijer, 19938, following administration of doxycycline hyclate at 5 mg/kg body weight/twice daily via milk replacer for 5 days to immature calves, plasma concentrations varied between 1.0 and 2.3 μg/ml. 
V študiji Meijerja, 19938, je po uporabi doksiciklinijevega hiklata z odmerkom 5 mg na kg telesne mase, ki se je dajal mladim teletom 5 dni dvakrat na dan z mlečnim nadomestkom, plazemska koncentracija nihala med 1,0 in 2,3 μg/ml Kremer, 19889, in Hartman, 199310 in 199411, sta pokazala visoko stopnjo odpornosti pri Pasteurella spp., izolirani iz klavnih telet na Nizozemskem.
5% (doxycycline hyclate) administered in milk replacer at a dose of 10 mg/kg body weight/ day for 46 days in the treatment of calves suffering from pneumonia caused by Mycoplasma and Past. 
5% (doksiciklinijev hiklat), ki se je dajal z mlečnim nadomestkom za zdravljenje telet s pljučnico, ki jo povzročata Mycoplasma in Past.
Calves, pigs and poultry 
Teleta, prašiči, perutnina
Cattle, 627-631 (1986) 13 Kuttler et al, Relative efficacy of two oxytetracycline formulations and doxycycline in the treatment of acute anaplasmosis in splenectomized calves, Am. J. Vet. Res., 39 (2), 347-349 (1978) 
13 Kuttler et al, Relative efficacy of two oxytetracycline formulations and doxycycline in the treatment of acute anaplasmosis in splenectomized calves.
Water Soluble Powder Pigs 
Vodotopni prašek
Calves 
KARENCA
Residue depletion data in pigs support a meat withdrawal period of 8 days when pigs are administered at 10 mg doxycycline hyclate/kg body weight/day for 5 days. 
Podatki o izločanju ostankov pri prašičih podpirajo karenco za meso 8 dni, kadar prašiči 5 dni prejemajo 10 mg doksiciklinijevega hiklata na kg telesne mase na dan.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD(S) OF ADMINISTRATION 
ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN DAJANJA ZDRAVILA
Pre-ruminant calves, pigs, chickens. 
Teleta pred nastopom prežvekovanja, prašiči, piščanci.
TARGET SPECIES Pre-ruminant calves, pigs, chickens 
CILJNE ŽIVALSKE VRSTE Teleta pred nastopom prežvekovanja, prašiči, piščanci
The chicken meat residue depletion data available support a meat withdrawal period of 5 days when chicken are administered 25 mg doxycycline hyclate/kg body weight/day for 5 days. 
Podatki o izločanju ostankov pri piščancih podpirajo karenco za meso 5 dni, kadar piščanci 5 dni prejemajo 25 mg doksiciklinijevega hiklata na kg telesne mase na dan.
Residue depletion data in chickens support a meat withdrawal period of 5 days when chicken are administered at 25 mg doxycycline hyclate/kg body weight/day for 5 days. 
Podatki o izločanju ostankov v piščančjem mesu podpirajo karenco za meso 5 dni, kadar piščanci 5 dni prejemajo 25 mg doksiciklinijevega hiklata na kg telesne mase na dan.
Residue depletion data in calves support a meat withdrawal period of 7 days when calves are administered at 5 mg doxycycline hyclate/kg body weight, twice a day for 5 days. 
Podatki o izločanju ostankov pri teletih podpirajo karenco za meso 7 dni, kadar teleta 5 dni dvakrat na dan prejemajo 5 mg doksiciklinijevega hiklata na kg telesne mase.
Pre-ruminant calves: 10 mg doxycycline hyclate /kg body weight / day, corresponding to 20 mg of product per kg body weight, for 3-5 consecutive days, divided over 2 administrations. 
Teleta pred nastopom prežvekovanja: 10 mg doksiciklinijevega hiklata /kg telesne mase/dan, ustreza 20 mg zdravila na kg telesne mase,
The calf meat residues depletion data available support a meat withdrawal period of 7 days when calves are administered 5 mg doxycycline hyclate/kg body weight twice a day for 5 days. 
Podatki o izločanju ostankov v telečjem mesu podpirajo karenco za meso 7 dni, kadar teleta 5 dni dvakrat na dan prejemajo 5 mg doksiciklinijevega hiklata na kg telesne mase.
• Infections of the respiratory tract caused by Mycoplasma spp., Escherichia coli, 
• Okužbe dihal, ki jih povzročajo Mycoplasma spp., Escherichia coli, Haemophilus paragallinarium in Bordetella avium.
Marketing authorisation holder: Dopharma Research B.V. Zalmweg 24 
Imetnik dovoljenja za promet z zdravilom: Dopharma Research B.V.
Doxycycline 50% WSP 
Doxycycline 50% WSP doksiciklinijev hiklat500 mg/g
• Amounts to be administered; 
• odmerjanju;
6.5 Nature and composition of immediate packaging White polypropylene container of 1000 g, covered with a low-density polyethylene lid. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products 
Bel polipropilenski vsebnik po 1000 g, prekrit s pokrovčkom iz polietilena nizke gostote.
SPECIAL WARNINGS 
POSEBNA NAVODILA ZA SHRANJEVANJE
• fast and deep breathing 
• hitro in globoko dihanje
ATC code: A10BK02. 
Oznaka ATC: A10BK02.
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference 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. 
Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
• about what you can do to prevent dehydration (see section 4 for signs of dehydration). 
• kaj lahko storite, da boste preprečili dehidracijo (glejte poglavje 4 glede znakov dehidracije)
Date of first authorisation: 15 November 2013 Date of latest renewal: 26 July 2018 
Datum prve pridobitve dovoljenja za promet: 15. 11. 2013 Datum zadnjega podaljšanja: 26. 07. 2018
• increased levels of “ketone bodies” in your urine or blood 
• zvečane koncentracije “ketonskih teles” v urinu in krvi
17% of patients were Hispanic. 
Sedemnajst odstotkov (17%) bolnikov je bilo Latinoameričanov.
Canagliflozin has no or negligible influence on the ability to drive and use machines. 
Kanagliflozin nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Severe allergic reaction (rare, may affect up to 1 in 1,000 people) Possible signs of severe allergic reaction may include: 
Huda alergijska reakcija (redko; lahko se pojavijo pri največ 1 od 1.000 bolnikov) Možni znaki hude alergijske reakcije lahko vključujejo:
• if you have type 1 diabetes because Invokana should not be used to treat this condition. 
• če imate sladkorno bolezen tipa 1, ker se za zdravljenje te bolezni zdravilo Invokana ne sme uporabljati
Treatment with canagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised. 
Zdravljenje s kanagliflozinom je mogoče ponovno uvesti, ko so vrednosti ketonov normalne in se bolnikovo stanje stabilizira.
• if you have severe liver problems. 
• če imate hude težave z jetri
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in na škatli poleg oznake "EXP".
• swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing. 
• otekanje obraza, ustnic, ust, jezika, grla, zaradi česar je lahko oteženo dihanje ali požiranje
• unusual sleepiness or tiredness 
• nenavadna zaspanost ali utrujenost
Children and adolescents Invokana is not recommended for children and adolescents under 18 years. 
Otroci in mladostniki Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Invokana ni priporočljiva.
If you stop taking Invokana 
Če ste prenehali jemati zdravilo Invokana
The racial distribution was 72% White, 16% Asian, 5% Black, and 8% other groups. 
Pripadnost različnim rasam je bila naslednja: 72% bolnikov je bilo bele rase, 16% azijske rase, 5% črne rase, 8% je bilo pripadnikov drugih etničnih skupin.
For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5, and 5.1. 
Za rezultate študij glede na kombinacije zdravil, učinke na urejenost glikemije in kardiovaskularne dogodke ter preiskovane populacije glejte poglavja 4.4, 4.5 in 5.1.
• It is important to check your feet regularly and adhere to any other advice regarding foot care and adequate hydration given by your healthcare professional. 
• Pomembno je, da si redno pregledujete stopala in upoštevate ostale nasvete zdravstvenih delavcev o negi stopal in vzdrževanju zadostne količine telesnih tekočin (hidracije).
• if you have ever had serious heart disease or if you have had a stroke. 
• če ste že imeli katero od resnih bolezni srca ali ste preživeli možgansko kap
In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute clinical measures if required. 
V primeru prevelikega odmerjanja je smiselno začeti z običajnimi podpornimi ukrepi, kot so odstranjevanje neabsorbiranega zdravila iz prebavil, klinično spremljanje bolnika in uvedba kliničnih ukrepov, če so potrebni.
If Fournier's gangrene is suspected, Invokana should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted. 
Če obstaja sum na Fournierovo gangreno, je treba zdravilo Invokana ukiniti in uvesti takojšnje zdravljenje (vključno z antibiotiki in kirurško odstranitvijo prizadetega tkiva).
Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2): 
Diabetična ketoacidoza (redko; lahko se pojavijo pri največ 1 od 1.000 bolnikov) Znaki diabetične ketoacidoze so (glejte tudi poglavje 2):
Before initiating Invokana, consider factors in the patient history that may increase the risk for amputation. 
Pred uvedbo zdravljenja z zdravilom Invokana je treba upoštevati tiste dejavnike v bolnikovi anamnezi, ki lahko povečajo tveganje za amputacije.
The Leydig cell tumours are associated with an increase in luteinizing hormone (LH), which is a known mechanism of Leydig cell tumour formation in rats. 
Tumorji Leydigovih celic so povezani s povečanjem koncentracije luteinizirajočega hormona (LH), kar je že znan mehanizem tvorbe tumorja Leydigovih celic pri podganah.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. 
Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Both improvement in glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes. 
Izboljševanje urejenosti glikemije in zmanjševanje obolevnosti ter mortalnost zaradi kardiovaskularnih bolezni sta bistvena elementa zdravljenja sladkorne bolezni tipa 2.
Monitoring of renal function is recommended as follows: - Prior to initiation of canagliflozin and at least annually, thereafter (see sections 4.2, 4.8, 5.1, and 
Priporočljivo je spremljanje delovanja ledvic, in sicer: - pred uvedbo kanagliflozina, nato pa najmanj enkrat na leto (glejte poglavja 4.2, 4.8, 5.1 in 5.2).
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking this medicine. 
Če karkoli od navedenega velja za vas (ali če o tem niste prepričani), se pogovorite z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.