natgillin/translations-raw huggingface dataset:
Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Hirobriz Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2adrenergic agonists. 
Iako nije bio zapažen klinički značajan učinak na kardiovaskularni sustav nakon primjene Hirobriz Breezhalera u preporučenim dozama, indakaterol treba, kao i druge beta2-adrenergičke agoniste, oprezno primjenjivati u bolesnika s kardiovaskularnim poremećajima (koronarna srčana bolest, akutni infarkt miokarda, srčane aritmije, hipertenzija), u bolesnika s konvulzivnim poremećajima ili tireotoksikozom te u bolesnika koji imaju neuobičajeni odgovor na beta2-adrenergičke agoniste.
Hirobriz Breezhaler has no or negligible influence on the ability to drive and use machines. 
Hirobriz Breezhaler ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
If paradoxical bronchospasm occurs Hirobriz Breezhaler should be discontinued immediately and alternative therapy substituted. 
Ako dođe do pojave paradoksalnog bronhospazma, primjenu Hirobriz Breezhalera treba odmah prekinuti i zamijeniti ga drugim lijekom.
Hirobriz Breezhaler, administered once a day at doses of 150 and 300 microgram consistently provided clinically significant improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) over 24 hours across a number of clinical pharmacodynamic and efficacy studies. 
Hirobriz Breezhaler primijenjen jedanput na dan u dozi od 150 i 300 mikrograma dosljedno je pružao klinički značajna poboljšanja plućne funkcije (mjereno forsiranim izdisajnim volumenom u jednoj sekundi, FEV1) tijekom 24 sata kroz brojna farmakodinamička ispitivanja i ispitivanja djelotvornosti.
How long to continue your treatment with Hirobriz Breezhaler Keep using your treatment with Hirobriz Breezhaler for as long as your doctor tells you. 
Koliko dugo trebate nastaviti svoje liječenje Hirobriz Breezhalerom Nastavite svoje liječenje Hirobriz Breezhalerom toliko dugo koliko Vam je rekao liječnik.
Hirobriz Breezhaler capsules must always be stored in the blister, and only removed immediately before use. 
Hirobriz Breezhaler kapsule se moraju uvijek čuvati u blisteru te se smiju izvaditi tek neposredno prije primjene.
At the recommended doses, the adverse reaction profile of Hirobriz Breezhaler in patients with COPD shows clinically insignificant systemic effects of beta2-adrenergic stimulation. 
U preporučenim dozama profil nuspojava Hirobriz Breezhalera u bolesnika s KOPB-om pokazuje klinički beznačajne sistemske učinke beta2-adrenergičke stimulacije.
Although indacaterol did not affect general reproductive performance in a rat fertility study, a decrease in the number of pregnant F1 offspring was observed in the peri- and post-developmental rat study at an exposure 14-fold higher than in humans treated with Hirobriz Breezhaler. 
Iako indakaterol nije u pravilu utjecao na reproduktivne parametre u ispitivanju plodnosti u štakora, zapažen je pad broja trudnih F1 potomaka u ispitivanju peri- i post-razvoja u štakora pri izloženosti 14 puta većoj od one u ljudi liječenih Hirobriz Breezhalerom.
What Hirobriz Breezhaler is and what it is used for What you need to know before you use Hirobriz Breezhaler How to use Hirobriz Breezhaler Possible side effects 
Što je Hirobriz Breezhaler i za što se koristi Što morate znati prije nego počnete primjenjivati Hirobriz Breezhaler Kako primjenjivati Hirobriz Breezhaler Moguće nuspojave
Hirobriz Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators. 
Hirobriz Breezhaler sadrži djelatnu tvar indakaterol koja pripada skupini lijekova koji se nazivaju bronhodilatatori.
Your Hirobriz Breezhaler pack: Each Hirobriz Breezhaler pack contains: one Hirobriz Breezhaler inhaler one or more blister containing Hirobriz Breezhaler capsules to be used in the inhaler. 
Vaše Hirobriz Breezhaler pakiranje: Jedno Hirobriz Breezhaler pakiranje sadrži: jedan Hirobriz Breezhaler inhalator jedan ili više blistera koji sadrže Hirobriz Breezhaler kapsule koje se koriste u inhalatoru.
The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Hirobriz Breezhaler inhaler. 
Preporučena doza je udisanje sadržaja jedne kapsule od 150 mikrograma jedanput na dan uz pomoć Hirobriz Breezhaler inhalatora.
Hirobriz Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed clinically meaningful improvements in lung function. 
Hirobriz Breezhaler primijenjen jedanput na dan u dozama od 150 mikrograma i 300 mikrograma pokazao je klinički značajna poboljšanja plućne funkcije.
Immediate hypersensitivity reactions have been reported after administration of Hirobriz Breezhaler. 
Reakcije preosjetljivosti su odmah bile prijavljene nakon primjene Hirobriz Breezhalera.
Hirobriz Breezhaler has not been investigated in patients with not well controlled diabetes mellitus. 
Hirobriz Breezhaler se nije ispitivao u bolesnika s loše kontroliranom šećernom bolešću.
The inhalation of the content of one 300 microgram capsule once a day, using the Hirobriz Breezhaler inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly for patients with severe COPD. 
Dokazano je da udisanje sadržaja kapsule od 300 mikrograma jedanput na dan uz pomoć Hirobriz Breezhaler inhalatora omogućava dodatnu kliničku korist s obzirom na dispneju, osobito u bolesnika s teškim KOPB-om.
Hirobriz Breezhaler is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). 
Hirobriz Breezhaler se koristi da bi se olakšalo disanje u odraslih bolesnika koji imaju poteškoće s disanjem zbog plućne bolesti koja se zove kronična opstruktivna plućna bolest (KOPB).
What you need to know before you use Hirobriz Breezhaler 
Što morate znati prije nego počnete primjenjivati Hirobriz Breezhaler
Breezhaler capsules with any other inhaler, and do not use Hirobriz Breezhaler inhaler to take any other capsule medicine. 
Hirobriz Breezhaler kapsule s nekim drugim inhalatorom i ne koristite Hirobriz Breezhaler inhalator za primjenu bilo kojeg drugog lijeka u kapsulama.
Only use the capsules with the inhaler provided in this pack (Hirobriz Breezhaler inhaler). 
Koristite samo kapsule koje ste dobili uz inhalator u ovom pakiranju (Hirobriz Breezhaler inhalator).
Hirobriz Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy. 
Hirobriz Breezhaler nije indiciran za liječenje akutnih epizoda bronhospazma, tj. kao lijek za hitna stanja.
There are no data available for use of Hirobriz Breezhaler in patients with severe hepatic impairment. 
Nema podataka o primjeni Hirobriz Breezhalera u bolesnika s teškim oštećenjem jetre.
The Hirobriz Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD. 
Program ispitivanja faze III tijekom razvoja Hirobriz Breezhalera uključivao je bolesnike s kliničkom dijagnozom umjerenog do teškog KOPB-a.
Show the pack of Hirobriz Breezhaler. 
Pokažite pakiranje Hirobriz Breezhalera.
Hirobriz Breezhaler contains lactose 
Hirobriz Breezhaler sadrži laktozu
In the event of deterioration of COPD during treatment with Hirobriz Breezhaler, a reevaluation of the patient and of the COPD treatment regimen should be undertaken. 
Ako dođe do pogoršanja KOPB-a tijekom liječenja Hirobriz Breezhalerom, bolesnika treba ponovno pregledati i provesti liječenje KOPB-a.
What Hirobriz Breezhaler contains - Each Hirobriz Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate. 
Što Hirobriz Breezhaler sadrži - Svaka Hirobriz Breezhaler 150 mikrogramska kapsula sadrži 150 mikrograma indakaterola u obliku indakaterolmaleata.
Talk to your doctor or pharmacist before using Hirobriz Breezhaler if you have asthma (in this case you should not use Hirobriz Breezhaler). 
Obratite se svom liječniku ili ljekarniku prije nego primijenite Hirobriz Breezhaler ako imate astmu (u tom slučaju ne biste trebali koristiti Hirobriz Breezhaler). ako imate problema sa srcem. ako imate epilepsiju. ako imate problema sa štitnjačom (tireotoksikoza). ako imate šećernu bolest.
The Hirobriz Breezhaler inhaler provided with each new prescription should be used. 
Potrebno je koristiti Hirobriz Breezhaler inhalator koji se dobije sa svakim novim receptom.
Hirobriz Breezhaler 150 microgram capsules have a black product code “IDL 150” printed above a black bar and a black company logo ( ) printed below the black bar. 
Hirobriz Breezhaler 150 mikrograma kapsule imaju crnu oznaku „IDL 150“ otisnutu iznad crne crte i crni logo proizvođača ( ) otisnut ispod crne crte.
Other medicines and Hirobriz Breezhaler 
Drugi lijekovi i Hirobriz Breezhaler
Always keep the Hirobriz Breezhaler inhaler and capsules in a dry place. 
Uvijek držite Hirobriz Breezhaler inhalator i kapsule na suhom mjestu.
If you forget to inhale a dose, inhale just one dose at the usual time the next day. 
Ako ste zaboravili primijeniti Hirobriz Breezhaler Ako ste zaboravili udahnuti svoju dozu, udahnite samo jednu dozu u uobičajeno vrijeme sljedećeg dana.
What Hirobriz Breezhaler is and what it is used for 
Što je Hirobriz Breezhaler i za što se koristi
Hirobriz Breezhaler is a single-dose inhalation device. 
Hirobriz Breezhaler je jednodozni inhalator.
An increase in the daily dose of Hirobriz Breezhaler beyond the maximum dose of 300 microgram is not appropriate. 
Povećanje dnevne doze iznad doze od 300 mikrograma nije primjereno.
Hirobriz Breezhaler 300 microgram capsules have a blue product code “IDL 300” printed above a blue bar and a blue company logo ( ) printed below the blue bar. 
Hirobriz Breezhaler 300 mikrograma kapsule imaju plavu oznaku „IDL 300“ otisnutu iznad plave crte i plavi logo proizvođača ( ) otisnut ispod plave crte.
The Hirobriz Breezhaler inhaler enables you to inhale the medicine contained in a capsule. 
Hirobriz Breezhaler inhalator Vam omogućava udisati lijek koji se nalazi u kapsuli.
Upon initiation of treatment with Hirobriz Breezhaler plasma glucose should be monitored more closely in diabetic patients. 
Nakon početka liječenja Hirobriz Breezhalerom, u bolesnika sa šećernom bolešću treba pomno pratiti glukozu u plazmi.
Carton containing 30 capsules and one Hirobriz Breezhaler inhaler. 
Kutija sadrži 30 kapsula i jedan Hirobriz Breezhaler inhalator.
Hirobriz Breezhaler capsules must not be swallowed. 
Hirobriz Breezhaler kapsule se ne smiju progutati.
Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). 
Hirobriz Breezhaler je indiciran za terapiju održavanja bronhodilatacije kod opstrukcije dišnih puteva u odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti (KOPB).
Carton containing 10 capsules and one Hirobriz Breezhaler inhaler. 
Kutija sadrži 10 kapsula i jedan Hirobriz Breezhaler inhalator.
The Hirobriz Breezhaler inhaler enables you to inhale the medicine contained in an Hirobriz Breezhaler capsule. 
Hirobriz Breezhaler inhalator Vam omogućuje udisanje lijeka koji se nalazi u Hirobriz Breezhaler kapsuli.
When you start a new pack, use the new Hirobriz Breezhaler inhaler that is supplied in the pack. 
Kada otvorite novo pakiranje, upotrijebite novi Hirobriz Breezhaler inhalator koji je priložen u pakiranju.
Driving and using machines It is unlikely that Hirobriz Breezhaler will affect your ability to drive and use machines. 
Nije vjerojatno da će Hirobriz Breezhaler utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
- Each Hirobriz Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate. 
- Svaka Hirobriz Breezhaler 300 mikrogramska kapsula sadrži 300 mikrograma indakaterola u obliku indakaterolmaleata.
INSTRUCTIONS FOR USE OF HIROBRIZ BREEZHALER INHALER 
UPUTE ZA PRIMJENU HIROBRIZ BREEZHALER INHALATORA
Hirobriz Breezhaler inhaler 
Hirobriz Breezhaler inhalator
Always use the new Hirobriz Breezhaler inhaler that comes with your new pack. 
Uvijek koristite Hirobriz Breezhaler inhalator koji se nalazi u Vašem novom pakiranju.
Never place a Hirobriz Breezhaler capsule directly into the mouthpiece of the Hirobriz Breezhaler inhaler. 
Nikada ne stavljajte Hirobriz Breezhaler kapsulu direktno u nastavak za usta Hirobriz Breezhaler inhalatora.
Only use the Hirobriz Breezhaler inhaler contained in this pack. 
Koristite samo Hirobriz Breezhaler inhalator koji se nalazi u ovom pakiranju.
• Only use the Hirobriz Breezhaler inhaler contained in this pack. 
• Koristite samo Hirobriz Breezhaler inhalator koji se nalazi u ovom pakiranju.
• When you start a new pack, only use the new Hirobriz Breezhaler inhaler that is supplied in the pack. 
• Kada otvorite novo pakiranje, koristite samo novi Hirobriz Breezhaler inhalator koji se nalazi u ovom pakiranju.
The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with Hirobriz Breezhaler in clinical studies of up to one year at doses up to twice the maximum recommended therapeutic dose. 
Iskustvo iz ispitivanja vezanih uz sigurnost liječenja Hirobriz Breezhalerom u trajanju do jedne godine u dozama dvostruko većim od najveće preporučene terapijske doze pokazuje da se s porastom izloženosti zbog interakcija ne smanjuje sigurnost primjene lijeka.
How much Hirobriz Breezhaler to use 
Koliko Hirobriz Breezhalera primijeniti
Never take the Hirobriz Breezhaler inhaler apart. 
Nikad nemojte rastavljati Hirobriz Breezhaler inhalator.
Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Hirobriz Breezhaler. 
Prema iskustvima nakon stavljanja gotovog lijeka u promet zabilježeni su slučajevi preosjetljivosti povezani s primjenom Hirobriz Breezhalera.
Do not swallow Hirobriz Breezhaler capsules. 
Ne gutajte Hirobriz Breezhaler kapsule.
What Hirobriz Breezhaler is 
Što je Hirobriz Breezhaler
Do not store the capsules in the Hirobriz Breezhaler inhaler. 
Ne čuvajte kapsule u Hirobriz Breezhaler inhalatoru.
How to store Hirobriz Breezhaler Contents of the pack and other information 
Kako Hirobriz Breezhaler izgleda i sadržaj pakiranja
Never blow into the mouthpiece of the Hirobriz Breezhaler inhaler. 
Nikad ne pušite u nastavak za usta Hirobriz Breezhaler inhalatora.
Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules indacaterol 
Hirobriz Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule Hirobriz Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule indakaterol
What Hirobriz Breezhaler is used for 
Za što se koristi Hirobriz Breezhaler
How to store Hirobriz Breezhaler 
Kako primjenjivati Hirobriz Breezhaler
Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules 
Hirobriz Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule
Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules 
Hirobriz Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule
Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules indacaterol 
Hirobriz Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule indakaterol
How to use Hirobriz Breezhaler 
Kako primijeniti Hirobriz Breezhaler
Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules indacaterol 
Hirobriz Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule indakaterol
Never wash the Hirobriz Breezhaler inhaler with water. 
Nikad nemojte prati Hirobriz Breezhaler vodom.
Immediate Packaging 
Pakiranje
Route of Administration 
Način uzimanja
Treatment may be restarted once the patient's condition has stabilised. 
Liječenje se može nastaviti nakon što se bolesnikovo stanje stabilizira.
The review of SGLT2 inhibitors was initiated at the request of European Commission in June 2015, under Article 20 of Regulation (EC) No 726/2004. 
Ponovna procjena SGLT2 inhibitora započela je na zahtjev Europske komisije u lipnju 2015. u skladu s člankom 20. Uredbe (EZ) br. 726/2004.
You may need emergency treatment and your diabetes medicine may need to be changed. 
Možda će vam trebati hitno liječenje i možda ćete morati promijeniti lijek za liječenje dijabetesa koji uzimate.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 25/04/2016 (Invokana, Jardiance) and 28/04/2016 (Forxiga, XigDuo, Synjardy, Vokanamet). 
Mišljenje CHMP-a proslijeđeno je Europskoj komisiji koja je objavila konačnu zakonski obvezujuću odluku primjenjivu u svim državama članicama EU-a od 25/04/2016 (Invokana, Jardiance) i 28/04/2016 (Forxiga, XigDuo, Synjardy, Vokanamet).
• Inform patients of the signs and symptoms of diabetic ketoacidosis and advise them to seek medical advice immediately if they develop such signs and symptoms. 
• Obavijestite bolesnike o znakovima i simptomima dijabetičke ketoacidoze i savjetujte ih da smjesta potraže liječnički savjet ako uoče takve znakove i simptome.
The CHMP opinion was then sent to the European Commission, which issued a legally-binding decision valid throughout the EU. 
Mišljenje CHMP-a zatim je poslano Europskoj komisiji koja je objavila zakonski obvezujuću odluku koja vrijedi na prostoru EU-a.
EMA's recommendations are based on an initial review by its Pharmacovigilance Risk Assessment Committee (PRAC). 
EMA-ine preporuke temelje se na prvotnom ocjenjivanju njezina Odbora za procjenu rizika na području farmakovigilancije (PRAC).
Healthcare professionals should be aware of possible atypical cases 
Zdravstveni radnici trebaju imati u vidu da mogu postojati atipični slučajevi
An atypical presentation of diabetic ketoacidosis can delay diagnosis and treatment. 
Atipična manifestacija dijabetičke ketoacidoze može odgoditi uspostavljanje dijagnoze i liječenje.
• SGLT2 inhibitors in the EU are available under the following trade names: Ebymect, Edistride, Forxiga, Invokana, Jardiance, Synjardy, Vokanamet and Xigduo. 
• SGLT2 inhibitori u EU-u su dostupni pod sljedećim trgovačkim nazivima: Ebymect, Edistride, Forxiga, Invokana, Jardiance, Synjardy, Vokanamet i Xigduo.
The benefits of these medicines continue to outweigh the risks in the treatment of type 2 diabetes. 
Koristi od tih lijekova i dalje nadmašuju s njima povezane rizike u liječenju dijabetesa tipa 2.
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which confirmed them and adopted the Agency's final opinion. 
Preporuke PRAC-a poslane su Odboru za lijekove za humanu uporabu (CHMP) koji ih je potvrdio i usvojio konačno mišljenje Agencije.
On 25 February 2016, the European Medicines Agency (EMA) confirmed recommendations1 to minimise the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors (a class of type 2 diabetes medicines). 
Europska agencija za lijekove (EMA) 25. veljače 2016. potvrdila je preporuke 1 o svođenju rizika od dijabetičke ketoacidoze u bolesnika koji uzimaju SGLT2 inhibitore (lijekove za liječenje dijabetesa razreda tipa 2) na najmanju moguću mjeru.
In addition, EMA recommended temporarily stopping SGLT2 inhibitors in patients who are undergoing major surgery or are in hospital due to serious illness. 
Osim toga, EMA je preporučila privremeni prekid liječenja SGLT2 inhibitorima u bolesnika koji trebaju biti podvrgnuti većem kirurškom zahvatu ili koji su u bolnici zbog teške bolesti.
• If you have any of the symptoms above while taking an SGLT2 inhibitor, contact a doctor or the nearest hospital straightaway even if your sugar level is not particularly high. 
• Ako imate bilo koji od navedenih simptoma tijekom uzimanja SGLT2 inhibitora, smjesta se obratite liječniku ili otiđite u najbližu bolnicu, čak i ako nemate izrazito visoku razinu šećera u krvi.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations. 
Procjenu je prvotno proveo Odbor za procjenu rizika na području farmakovigilancije (PRAC), odbor odgovoran za procjenu sigurnosnih pitanja u području lijekova za humanu uporabu, koji je iznio niz preporuka.
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion. 
Preporuke PRAC-a poslane su Odboru za lijekove za humanu uporabu (CHMP), odgovornom za pitanja koja se odnose na lijekove za humanu uporabu, koji je usvojio konačno mišljenje Agencije.
Finally, EMA reminded healthcare professionals that SGLT2 inhibitors are not authorised for type 1 diabetes, noting that cases of ketoacidosis have also occurred during off-label use and clinical trials in type 1 diabetes. 
Naposljetku, EMA je podsjetila zdravstvene djelatnike na to da SGLT2 inhibitori nisu odobreni za dijabetes tipa 1 uz napomenu da su slučajevi ketoacidoze zabilježeni i tijekom uporabe lijeka bez odobrenja i kliničkih ispitivanja dijabetesa tipa 1.
Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels. 
Dijabetička ketoacidoza ozbiljno je stanje pri kojem dolazi do komplikacije dijabetesa zbog niskih razina inzulina.
• Always consider the possibility of diabetic ketoacidosis in patients taking SGLT2 inhibitors who have non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. 
• Uvijek imajte u vidu mogućnost da se stanje dijabetičke ketoacidoze razvilo u bolesnika koji uzimaju SGLT2 inhibitore, a koji imaju nespecifične simptome kao što su mučnina, povraćanje, anoreksija, bol u trbuhu, prekomjerna žeđ, poteškoće pri disanju, smetenost, neuobičajen umor ili pospanost.
A number of these cases were atypical with patients having only moderately raised blood sugar levels and some of them occurred during offlabel use and clinical trials in patients with type 1 diabetes. 
Brojni su slučajevi bili atipični jer su bolesnici imali tek umjereno povećane razine šećera u krvi, a neki od slučajeva zabilježeni su tijekom uporabe lijeka bez odobrenja i kliničkih ispitivanja na bolesnicima s dijabetesom tipa 1.
Following a review of the cases, EMA recommended updating the product information of SGLT2 inhibitors to list diabetic ketoacidosis as a rare adverse reaction (affecting up to 1 in 1,000 patients). 
Nakon ponovnog ocjenjivanja dotičnih slučajeva, EMA je preporučila izmjenu informacija o proizvodu za SGLT2 inhibitore kako bi se dijabetička ketoacidoza uvrstila na popis rijetkih nuspojava (koja se može javiti u do 1 na 1000 bolesnika).
• Healthcare professionals are reminded that SGLT2 inhibitors are only authorised for treating type 2 diabetes. 
• Zdravstvene radnike ponovno se podsjeća na to da su SGLT2 inhibitori odobreni samo za liječenje dijabetesa tipa 2.
Symptoms include rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat. 
Simptomi uključuju brz gubitak težine, mučninu ili povraćanje, bol u trbuhu, prekomjernu žeđ, brzo i duboko disanje, smetenost, neuobičajenu pospanost ili umor, slatki miris daha, okus slatkoće ili metala u ustima ili drugačiji miris mokraće ili znoja.