FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhibitory antibodies against porcine Factor VIII (measured using a modification of the Nijmegen variation of the Bethesda assay) were detected before and after exposure to OBIZUR.
Croatian: Inhibicijska protutijela na svinjski faktor VIII (izmjerena korištenjem modifikacije Nijmegenove prilagodbe Bethesda testa) utvrđene su prije i nakon izlaganja lijeku OBIZUR.
English: Place the vial adapter package on a clean surface with the luer lock pointing up.
Croatian: Pakiranje adaptera za bočicu staviti na čistu površinu s luer-lockom okrenutim prema gore.
English: Healing phase
Croatian: Faza zacjeljivanja
English: Circulating antibodies (inhibitors) targeted against human Factor VIII have minimal or no cross reactivity against OBIZUR.
Croatian: Protutijela (inhibitori) u cirkulaciji usmjereni protiv faktora VIII imaju minimalnu ili nikakvu unakrsnu reaktivnost na lijek OBIZUR.
English: The total volume of reconstituted OBIZUR should be administered at a rate of 1 to 2 mL per minute.
Croatian: Ukupni volumen pripremljenog lijeka OBIZUR treba primjenjivati brzinom od 1 do 2 ml u minuti.
English: The procedures below are provided as general guidelines for the preparation and reconstitution of OBIZUR.
Croatian: Postupci opisani u nastavku navedeni su kao općenite upute za pripremu i rekonstituciju lijeka OBIZUR.
English: • Health care professional brochure including a detailed calculation of number of vials for a patient weighing for example 70 kg
Croatian: • Brošuru za zdravstvene radnike koja uključuje detaljni izračun broja bočica za bolesnika koji,
English: Three subjects included in pharmacokinetic analysis had a detectable anti-porcine factor VIII inhibitor titre at baseline (≥ 0.6 Bethesda Units (BU)/mL).
Croatian: Tri ispitanika uključena u farmakokinetičku analizu imala su mjerljiv titar protu-svinjskog faktor VIII inhibitora prije početka ispitivanja (≥0,6 jedinica Bethesda (BU)/ml).
English: Other medicines and OBIZUR
Croatian: Drugi lijekovi i OBIZUR
English: Factor VIII activity determined by the chromogenic assay is generally lower than Factor VIII activity determined by the one-stage clotting assay.
Croatian: Aktivnost faktora VIII koja se određuje kromogenim ispitivanjem općenito je niža od aktivnosti faktora VIII koja se određuje jednostupanjskim testom koagulacije.
English: After reconstitution the solution should be clear and colourless.
Croatian: Otopina nakon pripreme treba biti bistra i bezbojna.
English: Invert the vial; push the air in the syringe into the vial and withdraw the reconstituted OBIZUR into the syringe (Figure I).
Croatian: Okrenuti bočicu naopako; gurnuti zrak iz štrcaljke u bočicu i izvući rekonstituirani lijek OBIZUR u štrcaljku (Slika I).
English: It is strongly recommended that every time OBIZUR is used, the name and batch number of the medicine are recorded by the medical professional to maintain a link between your treatment and the batch of the medicine.
Croatian: Preporučuje se da zdravstveni radnik zabilježi naziv i broj serije lijeka svaki put kada se OBIZUR primjeni, s ciljem održavanja veze između Vašeg liječenja i serije lijeka.
English: • Same number of 1 mL solvent syringes and sterile vial adapters
Croatian: • Isti broj štrcaljki s otapalom od 1 ml i sterilnim adapterima za bočice
English: The required initial dose of Obizur for a patient is calculated using the following formula: Initial dose (U/kg)  Product strength (U/vial) × Body weight (kg) = Number of vials e.g. for a 70 kg subject the number of vials for an initial dose will be calculated as follows: 200 U/kg  500 U/vial × 70 kg = 28 vials
Croatian: Potrebna početna doza lijeka OBIZUR za bolesnika izračunava se korištenjem sljedeće formule: Početna doza (U/kg)  jačina lijeka (U/bočica) × tjelesna težina (kg) = Broj bočica npr. za ispitanika od 70 kg broj bočica za početnu dozu izračunava se ovako: 200 U/kg  500 U/bočica × 70 kg = 28 bočica
English: Patients with acquired haemophilia may develop inhibitory antibodies to porcine Factor VIII.
Croatian: Bolesnici sa stečenom hemofilijom mogu razviti inhibicijska protutijela na svinjski faktor VIII.
English: Each vial contains 4.4 mg (198 mM) sodium per ml of reconstituted solution.
Croatian: Jedna bočica sadrži 4,4 mg (198 mM) natrija po ml rekonstituirane otopine.
English: Manufacturer Baxter AG Industriestrasse 67 A-1221 Vienna Austria
Croatian: Proizvođač Baxter AG Industriestrasse 67 A-1221 Vienna Austrija
English: OBIZUR is used for the treatment of bleeding episodes in adults with acquired haemophilia (a bleeding disorder caused by lack of Factor VIII activity due to antibody development).
Croatian: OBIZUR se koristi za liječenje epizoda krvarenja u odraslih sa stečenom hemofilijom (poremećaj krvarenja prouzročen nedostatkom aktivnosti faktora VIII uslijed razvoja protutijela).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Obizur water for injections.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za OBIZUR voda za injekcije.
English: The one-stage assay is recommended because it has been used in determination of the potency and the mean recovery rate of OBIZUR (see sections 4.2 and 5.2).
Croatian: Jednostupanjski test se preporučuje zato što je korišten u određivanju aktivnosti i srednje vrijednosti stupnja poboljšanja lijeka OBIZUR (vidjeti dijelove 4.2 i 5.2).
English: Baxter AG Industriestrasse 67 A-1221 Vienna AUSTRIA
Croatian: Baxter AG Industriestrasse 67 A-1221 Vienna AUSTRIJA
English: Excipient(s) with known effect Each vial contains 4.4 mg (198 mM) sodium per ml of reconstituted solution.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedna bočica sadrži 4,4 mg (198 mM) natrija po ml rekonstituirane otopine.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Croatian: Bolesnike je potrebno upozoriti da u slučaju pojave simptoma preosjetljivosti odmah prestanu uzimati ovaj lijek te se obrate svom liječniku.
English: Antibodies to baby hamster kidney cell protein were not detected in subjects after exposure to OBIZUR.
Croatian: Protutijela na protein bubrežnih stanica mladunčadi kineskog hrčka nisu detektirana u ispitanika nakon izloženosti lijeku OBIZUR.
English: What OBIZUR contains - The active substance is susoctocog alfa (antihaemophilic Factor VIII, porcine sequence produced by recombinant DNA technology).
Croatian: Što OBIZUR sadrži - Djelatna tvar je susoktokog alfa (koagulacijski faktor VIII, svinjska sekvencija proizvedena tehnologijom rekombinantne DNK).
English: The recommended initial dose is 200 U per kilogram bodyweight, given by injection.
Croatian: Preporučena početna doza je 200 U po kilogramu tjelesne težine, primijenjena injekcijom.
English: Use OBIZUR immediately and within 3 hours after reconstitution when stored at room temperature.
Croatian: 13. OBIZUR treba primijeniti odmah i unutar 3 sata nakon rekonstitucije kada se čuva na sobnoj temperaturi.
English: Do not use this medicine after the expiry date which is stated on the carton, on the vial and on the pre-filled syringe after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, bočici i napunjenoj štrcaljki iza oznake „Rok valjanosti“.
English: Allergic type hypersensitivity reactions are possible with OBIZUR.
Croatian: Moguće su reakcije preosjetljivosti alergijskog tipa na lijek OBIZUR.
English: Marketing authorisation holder Baxalta Innovations GmbH Industriestrasse 67
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Baxalta Innovations GmbH Industriestrasse 67
English: OBIZUR 500 U powder and solvent for solution for injection Susoctocog alfa
Croatian: OBIZUR 500 U prašak i otapalo za otopinu za injekciju susoktokog alfa
English: The number of units of Factor VIII administered is expressed in Units (U) that are derived from an in-house standard that has been calibrated with the current WHO standard for Factor VIII products.
Croatian: Units, U) koje potječu od internog standarda koji je kalibriran postojećim standardom Svjetske zdravstvene organizacije (WHO) za lijekove koji sadrže faktor VIII.
English: OBIZUR contains sodium This medicine contains 4.4 mg sodium per milliliter once it is made up.
Croatian: Ovaj lijek sadrži 4,4 mg natrija po mililitru nakon što se pripremi.
English: The one-stage clotting assay for Factor VIII is recommended as it has been used in determination of the potency of OBIZUR and the mean recovery rate (see section 4.4 and 5.2).
Croatian: Preporučuje se jednostupanjski test koagulacije za Faktor VIII jer se koristi za određivanje aktivnosti lijeka OBIZUR i srednje vrijednosti stupnja poboljšanja (vidjeti dio 4.4 i 5.2).
English: No interactions of OBIZUR with other medicines are known.
Croatian: Nisu poznate interakcije lijeka OBIZUR s drugim lijekovima.
English: 6.6 Special precautions for disposal and other handling After reconstitution, the solution is clear, colourless, free from particles and has a pH of 6.8 to 7.2.
Croatian: • uređaj za prijenos tekućine s ugrađenim plastičnim šiljkom 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Otopina je nakon rekonstitucije bistra, bezbojna, bez vidljivih čestica i pH otopine iznosi između 6,8 i 7,2.
English: • powder vials (type I glass) with a stopper (butyl rubber) and a flip-off seal
Croatian: • bočice s praškom (staklo tip I) s gumenim čepom (butilna guma) i "flip-off" prstenom
English: Extensive cutaneous purpura do not necessarily require treatment.
Croatian: Nije uvijek potrebno liječenje opsežne purpure na koži.
English: The reconstituted solution should be inspected visually for particulate matter before administration.
Croatian: Rekonstituiranu otopinu treba prije primjene vizualno pregledati na postojanje čestica.
English: Calcium chloride dihydrate Sucrose
Croatian: Kalcijev klorid dihidrat Saharoza
English: Each powder vial contains nominally 500 Units of B domain deleted antihaemophilic Factor VIII (recombinant), porcine sequence, susoctocog alfa.
Croatian: Svaka bočica s praškom nominalno sadrži 500 jedinica koagulacijskog faktora VIII (rekombinantnog) s uklonjenom B-domenom, svinjska sekvencija, susoktokog alfa.
English: Treatment with OBIZUR will be conducted by a doctor who is experienced in the care of patients with haemophilia (bleeding disorders).
Croatian: Liječenje lijekom OBIZUR će započeti liječnik s iskustvom u liječenju bolesnika s hemofilijom (poremećaji krvarenja).
English: Remove the plastic cap from the OBIZUR powder vial (Figure A).
Croatian: Skinuti plastični zatvarač s bočice praška OBIZUR (Slika A).
English: It is strongly recommended that every time that OBIZUR is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Croatian: Strogo se preporučuje da se svaki put kada se bolesniku primijeni OBIZUR zabilježi naziv i broj serije lijeka kako bi se vodila evidencija o primijenjenim brojevima serije svakom bolesniku.
English: The product is for in-patient administration only.
Croatian: Lijek je namijenjen samo za primjenu na hospitaliziranim bolesnicima.
English: Each powder vial contains 500 U susoctocog alfa.
Croatian: Jedna bočica s praškom sadrži 500 U susoktokoga alfa.
English: How to use OBIZUR
Croatian: Kako primjenjivati OBIZUR
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology or repeated dose toxicity.However, in repeated dose toxicity studies, the incidence and severity of glomerulopathy observed in monkeys intravenously administered OBIZUR at doses of 75, 225 and 750 U/kg/day tended to increase over time.
Croatian: Međutim, u ispitivanjima toksičnosti ponovljenih doza, incidencija i težina glomerulopatije zabilježene u majmuna kojima je intravenski primijenjen OBIZUR u dozama od 75, 225 i 750 U/kg/dan povećavale su se tijekom vremena.
English: If you stop using OBIZUR
Croatian: Ako prestanete primjenjivati lijek OBIZUR
English: Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII.
Croatian: Liječenje krvarenja u bolesnika sa stečenom hemofilijom prouzročenom protutijelima na faktor VIII.
English: • Alcohol swabs
Croatian: • Vate natopljene alkoholom
English: Tabulated list of adverse reactions:
Croatian: Tablični popis nuspojava:
English: The recommended first dose is 200 U per kilogram bodyweight given by intravenous injection.
Croatian: Preporučena prva doza je 200 U po kilogramu tjelesne težine, primijenjena injekcijom u venu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S PRAŠKOM
English: Once all vials have been reconstituted, connect a large syringe to the vial adapter by gently pushing the syringe tip down onto the luer lock in the centre of the vial adapter, and turning clockwise until the syringe is secured.
Croatian: Nakon što su sve bočice rekonstituirane, priključiti veliku štrcaljku na adapter za bočicu nježnim guranjem vrha štrcaljke prema dolje na luer lock u sredini adaptera za bočicu, i okretanjem u smjeru kazaljke na satu dok se štrcaljka ne pričvrsti.
English: Sodium chloride Calcium chloride dihydrate Sucrose
Croatian: Natrijev klorid Kalcijev klorid dihidrat Saharoza
English: How to store OBIZUR
Croatian: Kako čuvati OBIZUR
English: Bring the OBIZUR powdervial and the pre-filled solvent syringe to room temperature.
Croatian: Bočica praška OBIZUR i napunjena štrcaljka otapala trebaju dosegnuti sobnu temperaturu.
English: Administer the reconstituted OBIZUR intravenously at a rate of 1 to 2 mL per minute.
Croatian: Primijeniti lijek OBIZUR intravenski brzinom od 1 do 2 ml u minuti.
English: Place the vial adapter over the OBIZUR powder vial and firmly push the filter spike of the vial adapter through the centre of the OBIZUR powder vial's rubber circle until the clear plastic cap snaps onto the vial (Figure F).
Croatian: Staviti adapter za bočicu preko bočice praška OBIZUR i čvrsto gurnuti šiljasti priključak s filterom adaptera za bočicu kroz središte gumenog kruga bočice praška OBIZUR dok se proziran plastični zatvarač ne zakvači za bočicu (Slika F).
English: NAME OF THE MEDICINAL PRODUCT OBIZUR 500 U powder and solvent for solution for injection
Croatian: NAZIV LIJEKA OBIZUR 500 U prašak i otapalo za otopinu za injekciju
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL FOR THE SOLVENT
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA NAPUNJENOJ ŠTRCALJKI S OTAPALOM
English: No interactions of OBIZUR with other medicinal products have been reported.
Croatian: Nisu prijavljene interakcije lijeka OBIZUR s drugim lijekovima.
English: The frequency and duration of administration will depend on how well OBIZUR is working for you.
Croatian: Učestalost i trajanje primjene ovisit će o učinkovitosti lijeka OBIZUR u Vas.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OBIZUR 500 U powder for solution for injection Susoctocog alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA OBIZUR 500 U prašak za otopinu za injekciju susoktokog alfa i.v.
English: One, five, ten vials
Croatian: OBLIK I SADRŽAJ Jedna, pet, deset bočica
English: OBIZUR contains the active substance susoctocog alfa, antihaemophilic Factor VIII, porcine sequence.
Croatian: OBIZUR sadrži djelatnu tvar susoktokog alfa, koagulacijski faktor VIII, svinjska sekvencija.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml of solution contains approximately 500 U of antihaemophilic factor VIII (recombinant), porcine sequence, susoctocog alfa after reconstitution.
Croatian: Jedan ml otopine sadrži približno 500 U koagulacijskog faktora VIII (rekombinantnog), svinjska sekvencija, susoktokog alfa nakon rekonstitucije.
English: Peel back the cover of the vial adapter package (Figure B).
Croatian: Skinuti pokrov pakiranja adaptera za bočicu (Slika B).
English: • pre-filled (type I glass) syringes with a stopper (butyl rubber), a rubber tip cap and a Luer Lock adapter
Croatian: • napunjene štrcaljke (staklo tip I) s gumenim čepom (butilna guma), gumenim zatvaračem vrha i
English: Unscrew the large syringe counterclockwise from the vial adapter, and repeat this process for all reconstituted vials of OBIZUR until the total volume to be administered is reached.
Croatian: Odviti veliku štrcaljku u smjeru suprotnom od kazaljke na satu s adaptera za bočicu i ponoviti postupak za sve rekonstituirane bočice lijeka OBIZUR dok se ne dostigne ukupan volumen koji treba primijeniti.
English: rFVIIa, activated prothrombin-complex concentrate, tranexamic acid) prior to first treatment with OBIZUR.
Croatian: U jedanaest ispitanika zabilježeno je uzimanje lijekova protiv krvarenja (primjerice rFVIIa, aktivirani koncentrat protrombinskog kompleksa, traneksamična kiselina) prije prvog liječenja lijekom OBIZUR.
English: OBIZUR is produced by recombinant DNA technology in baby hamster kidney cells.
Croatian: OBIZUR se proizvodi tehnologijom rekombinantne DNK u bubrežnim stanicama mladunčadi kineskog hrčka.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatak V.
English: Patients developing inhibitory antibodies to OBIZUR Your doctor may check if you have inhibitory antibodies to porcine Factor VIII.
Croatian: Vaš će liječnik možda provjeriti imate li inhibicijska protutijela na svinjski faktor VIII.
English: Snap off the tamper resistant cap of the pre-filled solvent syringe (Figure C).
Croatian: Skinuti zaštitni zatvarač s napunjene štrcaljke s otapalom (Slika C).
English: With one hand hold the powder vial and vial adapter, and with the other hand firmly grasp the barrel of the pre-filled solvent syringe and in a counterclockwise motion unscrew the syringe from the vial adapter (Figure H).
Croatian: 12. Jednom rukom držati bočicu i adapter bočice, a drugom rukom čvrsto uhvatiti tijelo napunjene štrcaljke s otapalom i pokretom u smjeru suprotnom od kazaljke na satu odviti štrcaljku s adaptera za bočicu (Slika H).
English: Initial dose (U/kg)  Product strength (U/vial) × Body weight (kg) = Number of vials e.g. for a 70 kg subject the number of vials for an initial dose will be calculated as follows: 200 U/kg  500 U/vial × 70 kg = 28 vials
Croatian: Početna doza (U/kg)  jačina lijeka (U/bočica) × tjelesna težina (kg) = Broj bočica npr. za ispitanika od 70 kg broj bočica za početnu dozu izračunava se ovako:
English: While firmly holding the vial adapter package connect the pre-filled solvent syringe to the vial adapter by pushing the syringe tip down onto the luer lock in the centre of the vial adapter, and turning it clockwise until the syringe is secured.
Croatian: Čvrsto držeći pakiranje adaptera za bočicu, priključiti napunjenu štrcaljku s otapalom na adapter za bočicu guranjem vrha štrcaljke prema dolje na luer lock u sredini adaptera za bočicu, i njegovim okretanjem u smjeru kazaljke na satu dok se štrcaljka ne pričvrsti.
English: Preferred MedDRA term Frequency
Croatian: MedDRA preporučeni naziv Učestalost
English: Obizur is a recombinant, B-domain deleted, porcine sequence Factor VIII (susoctocog alfa).
Croatian: OBIZUR je rekombinantni faktor VIII s uklonjenom B-domenom i svinjskom sekvencijom (susoktokog alfa).
English: The solution should be clear and colorless in appearance.
Croatian: Otopina treba biti bistra i bezbojna.
English: Factor VIII activity was measured by the one-stage clotting assay.
Croatian: Aktivnost faktora VIII izmjerena je jednostupanjskim testom koagulacije.
English: Do not administer if particulate matter or discoloration is found.
Croatian: Lijek se ne smije primijeniti ako su prisutne čestice ili promjena boje.
English: Do not remove the vial adapter from the package.
Croatian: Ostaviti adapter za bočicu u pakiranju.
English: Do not administer if particulate matter or discoloration is observed.
Croatian: Ne smiju se primjenjivati otopine s vidljivim česticama ili promijenjene boje.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Croatian: OBLIK Prašak i otapalo za otopinu za injekciju Prašak je bijele boje.
English: Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Prije primjene rekonstituiranog lijeka treba vizualno provjeriti jesu li u njemu prisutne čestice i je li promijenio boju.
English: Subsequent Dose
Croatian: DODATAK
English: Baseline hFVIII activity t½ (h)
Croatian: Početna aktivnost hFVIII
English: Do not use if particulate matter or discoloration is observed.
Croatian: Lijek se ne smije koristiti ako su prisutne čestice ili promjena boje.
English: What Synjardy looks like and contents of the pack
Croatian: Kako Synjardy izgleda i sadržaj pakiranja
English: • cimetidine, a medicine used to treat stomach problems.
Croatian: • cimetidin, lijek za liječenje problema sa želucem.
English: What Synjardy contains
Croatian: Što Synjardy sadrži
English: Diabetic ketoacidosis a,
Croatian: Dijabetička ketoacidoza a, b
English: Gastrointestinal symptoms
Croatian: Gastrointestinal ni simptomi
English: Table 9: Treatment effect for the primary composite endpoint, its components and mortality
Croatian: Tablica 9: Učinak liječenja za primarnu kompozitnu mjeru ishoda, njezine komponente i mortalitet Placebo
English: These symptoms could be a sign of “diabetic ketoacidosis”a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Croatian: Ovi simptomi mogu biti znak „dijabetičke ketoacidoze“problema koji se može javiti uz šećernu bolest zbog povišenih razina „ketonskih tijela“ u mokraći ili krvi što je vidljivo u nalazima pretraga.
English: Very common Common Uncommon Rare
Croatian: Manje često Rijetko Vrlo rijetko
English: General Synjardy should not be used in patients with type 1 diabetes.
Croatian: Općenito Synjardy se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1.
English: Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see section 2, ‘Warnings and precautions'): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Croatian: Dijabetička ketoacidoza, rijetko zabilježena (može se javiti u do 1 na 1000 osoba) Ovo su znakovi dijabetičke ketoacidoze (vidjeti dio 2, „Upozorenja i mjere opreza“): - povišene razine „ketonskih tijela” u mokraći ili krvi - nagli gubitak tjelesne težine - mučnina ili povraćanje - bol u trbuhu - prekomjerna žeđ - ubrzano i duboko disanje - smetenost - neuobičajena pospanost ili umor - zadah slatkog mirisa, slatki ili metalni okus u ustima ili drugačiji miris mokraće ili znoja.
English: Blood creatinine increased/ Glomerular filtration rate decreased Haematocrit increased
Croatian: Povišena razina kreatinina u krvi/snižena brzina glomerularne filtracije Povišena vrijednost hematokrita
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „Rok valjanosti“.
English: Complicated urinary tract infections (including serious urinary infections, pyelonephritis or urosepsis) occurred at a similar frequency in patients treated with empagliflozin compared to placebo.
Croatian: Komplicirane infekcije mokraćnog sustava (uključujući ozbiljne urinarne infekcije, pijelonefritis ili urosepsa) javile su se sa sličnom učestalošću u bolesnika liječenih empagliflozinom u usporedbi s placebom.