FrancophonIA/ELRC3.0 huggingface dataset:
English: Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules lomitapide
Croatian: Lojuxta 40 mg tvrde kapsule Lojuxta 60 mg tvrde kapsule lomitapid
English: Based on observations of decreased essential fatty acid and vitamin E levels in clinical studies, patients should take daily dietary supplements that provide 400 IU vitamin E and approximately 200 mg linoleic acid, 110 mg eicosapentaenoic acid (EPA), 210 mg alpha linolenic acid (ALA) and 80 mg docosahexaenoic acid (DHA) per day, throughout treatment with Lojuxta.
Croatian: Stoga bolesnici trebaju svaki dan uzimati dodatke prehrani koji sadrže 400 IU vitamina E, približno 200 mg linolne kiseline, 110 mg eikosapentaenske kiseline (EPA), 210 mg alfa linolenske kiseline (ALA) i 80 mg dokosaheksaenske kiseline (DHA).
English: Non high-density lipoprotein cholesterol (Non-HDL-C) (mg/dL)
Croatian: Trigliceridi (TG) (mg/dl)a ne-HDL kolesterol (lipoproteini koji nisu visoke gustoće) (mg/dl)
English: • Lojuxta 5 mg is an orange cap/orange body hard capsule with “5 mg” printed on the body and “A733“ printed on the cap in black ink.
Croatian: • Lojuxta 5 mg tvrde kapsule imaju narančastu kapicu i narančasto tijelo s oznakom „5 mg“ otisnutom na tijelu, i „A733“ na kapici crnom bojom.
English: Lojuxta 60 mg hard capsules
Croatian: Lojuxta 60 mg tvrde kapsule
English: Excipient with known effect Each hard capsule contains 140.23 mg of lactose (as monohydrate) (see section 4.4).
Croatian: Jedna tvrda kapsula sadrži 140,23 mg laktoze (u obliku hidrata) (vidjeti dio 4.4).
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava Manje često anemija
English: Excipient with known effect Each hard capsule contains 129.89 mg of lactose (as monohydrate) (see section 4.4).
Croatian: Jedna tvrda kapsula sadrži 129,89 mg laktoze (u obliku hidrata) (vidjeti dio 4.4).
English: Alopecia
Croatian: Nepoznato alopecija
English: Lojuxta 20 mg hard capsules
Croatian: Lojuxta 20 mg tvrde kapsule
English: • Lojuxta 20 mg is a white cap/white body hard capsule with “20 mg” printed on the body and “A733” printed on the cap in black ink.
Croatian: • Lojuxta 20 mg tvrde kapsule imaju bijelu kapicu i bijelo tijelo s oznakom „20 mg“ otisnutom na tijelu, i „A733“ na kapici crnom bojom.
English: Lojuxta 10 mg hard capsules
Croatian: Lojuxta 10 mg tvrde kapsule
English: • combined oral contraceptives (e.g. ethinylestradiol, norgestimate)
Croatian: • kombinirane kontracepcijske tablete koje se uzimaju na usta (npr. etinilestradiol, norgestimat)
English: Frequency of adverse reactions in elevated LDL-C patients System Organ Class
Croatian: Tablica 4: Učestalosti nuspojava u bolesnika s povišenim LDL kolesterolom Klasifikacija organskih sustava Učestalost
English: Parameter/Abnormality
Croatian: Parametar (jedinice)
English: Each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide.
Croatian: Jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 20 mg lomitapida.
English: • The capsule shell for the 40 mg capsule contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172).
Croatian: • Ovojnica kapsule od 40 mg sadrži želatinu, titanijev dioksid (E171) i žuti željezov oksid (E172).
English: Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide.
Croatian: Jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 5 mg lomitapida.
English: You should not take more than 40 mg of simvastatin when using Lojuxta (see section 2 under ‘Do not take Lojuxta')
Croatian: Kada primjenjujete lijek Lojuxta ne smijete uzeti više od 40 mg simvastatina (pogledajte dio 2. pod
English: • anti-histamine medicines to treat hayfever (e.g. fexofenadine)
Croatian: • antihistaminske lijekove za liječenje peludne groznice (npr. feksofenadin).
English: Lojuxta 30 mg hard capsules
Croatian: Lojuxta 30 mg tvrde kapsule
English: Medicinal products
Croatian: FARMACEUTSKI
English: Lojuxta 60 mg: each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide.
Croatian: Lojuxta 60 mg: jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 60 mg lomitapida.
English: • Lojuxta 60 mg is a yellow cap/yellow body hard capsule with “60 mg” printed on the body and “A733” printed on the cap in black ink.
Croatian: • Lojuxta 60 mg tvrde kapsule imaju žutu kapicu i žuto tijelo s oznakom „60 mg“ otisnutom na tijelu, i „A733“ na kapici crnom bojom.
English: Lojuxta 40 mg hard capsules
Croatian: Lojuxta 40 mg tvrde kapsule
English: Blood bilirubin increased Gamma-glutamyltransferase increased Neutrophil percentage increased Protein urine
Croatian: Manje često smanjena težina povišen bilirubin u krvi povišena gama-glutamiltransferaza povišen postotak neutrofila proteini u mokraći produljeno protrombinsko vrijeme abnormalnosti testova plućne funkcije povišen broj bijelih krvnih stanica
English: Each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide.
Croatian: Jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 60 mg lomitapida.
English: Abdominal pain upper Abdominal distension Abdominal pain Vomiting
Croatian: Često bol u gornjem dijelu trbuha abdominalna distenzija bol u trbuhu povraćanje nelagoda u trbuhu dispepsija eruktacija bol u donjem dijelu trbuha česta pražnjenja crijeva
English: Lomitapide Observational Worldwide Evaluation Registry Information about the existence and importance of the registry aiming to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide.
Croatian: Informacije o postojanju i važnosti registra u cilju sustavnog prikupljanja podataka o ishodima sigurnosti i učinkovitosti u bolesnika liječenih lomitapidom.
English: Each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide.
Croatian: Jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 30 mg lomitapida.
English: The capsule is an orange cap/orange body hard capsule of 19.4 mm, printed with black ink imprinted with “5 mg” on body and “A733” on cap.
Croatian: Tvrda kapsula veličine 19,4 mm sastoji se od narančaste kapice i narančastog tijela, s otisnutim oznakama crnom tintom „5 mg“ na tijelu i „A733“ na kapici.
English: Lojuxta 30 mg: each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide.
Croatian: Lojuxta 30 mg: jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 30 mg lomitapida.
English: Lojuxta 10 mg: each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.
Croatian: Lojuxta 10 mg: jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 10 mg lomitapida.
English: gamma-GT, serum albumin (liver injury); high sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), CK-18 Fragment, NashTest (liver inflammation);
Croatian: C-reaktivni protein visoke osjetljivosti (hs-CRP), brzina sedimentacije eritrocita (ESR), fragment CK-18, NASH test (upala jetre); panel biomarkera za uznapredovalu fibrozu jetre (Enhanced Liver Fibrosis, ELF), Fibrometer, omjer AST/ALT, rezultat Fib-4, Fibrotest (fibroza jetre).
English: • The capsule shell for the 60 mg capsule contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172).
Croatian: • Ovojnica kapsule od 60 mg sadrži želatinu i titanijev dioksid (E171) i žuti željezov oksid (E172.
English: The capsule is an orange cap/yellow body hard capsule of 21.6 mm, printed with black ink imprinted with “30 mg” on body and “A733” on cap.
Croatian: Tvrda kapsula veličine 21,6 mm sastoji se od narančaste kapice i žutog tijela, s otisnutim oznakama crnom tintom „30 mg“ na tijelu i „A733“ na kapici.
English: The capsule is a white cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “20 mg” on body and “A733” on cap.
Croatian: Tvrda kapsula veličine 19,4 mm sastoji se od bijele kapice i bijelog tijela, s otisnutim oznakama crnom tintom „20 mg“ na tijelu i „A733“ na kapici.
English: • Lojuxta 30 mg is an orange cap/yellow body hard capsule with “30 mg” printed on the body and “A733” printed on the cap in black ink.
Croatian: • Lojuxta 30 mg tvrde kapsule imaju narančastu kapicu i žuto tijelo s oznakom „30 mg“ otisnutom na tijelu, i „A733“ na kapici crnom bojom.
English: Very-low-density lipoprotein cholesterol (VLDL-C) (mg/dL)
Croatian: VLDL kolesterol (lipoproteini vrlo niske gustoće) (mg/dl)
English: The use of St. John's Wort should be avoided with Lojuxta.
Croatian: Uz lijek Lojuxta valja izbjegavati upotrebu gospine trave.
English: The capsule is a yellow cap/yellow body hard capsule of 23.4 mm, printed with black ink imprinted with “60 mg” on body and “A733” on cap.
Croatian: Tvrda kapsula veličine 23,4 mm sastoji se od žute kapice i žutog tijela, s otisnutim oznakama crnom tintom „60 mg“ na tijelu i „A733“ na kapici.
English: Lojuxta 40 mg: each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide.
Croatian: Lojuxta 40 mg: jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 40 mg lomitapida.
English: CYP3A4, lomitapide AUC increased approximately 27-fold and Cmax increased approximately 15-fold.
Croatian: Kada je lomitapid 60 mg primjenjivan s ketokonazolom 200 mg dvaput na dan, jakim inhibitorom CYP3A4, došlo je do povećanja AUC lomitapida približno 27 puta, a Cmax približno 15 puta.
English: Each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide.
Croatian: Jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 40 mg lomitapida.
English: Recommendation concerning co-administration with Lojuxta
Croatian: Učinci na razine lomitapida Preporuke za istodobnu primjenu s Lojuxtom
English: • Lojuxta 10 mg is an orange cap/white body hard capsule with “10 mg” printed on the body and “A733“ printed on the cap in black ink.
Croatian: • Lojuxta 10 mg tvrde kapsule imaju narančastu kapicu i bijelo tijelo s oznakom „10 mg“ otisnutom na tijelu, i „A733“ na kapici crnom bojom.
English: Each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.
Croatian: Jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 10 mg lomitapida.
English: Dose reduction of the P gp substrate should be considered when used concomitantly with Lojuxta.
Croatian: Kada se primjenjuje istodobno s Lojuxtom valja razmotriti smanjenje doze supstrata P-gp-a.
English: • Lojuxta 40 mg is a yellow cap/white body hard capsule with “40 mg” printed on the body and “A733” printed on the cap in black ink.
Croatian: • Lojuxta 40 mg tvrde kapsule imaju žutu kapicu i bijelo tijelo s oznakom „40 mg“ otisnutom na tijelu, i „A733“ na kapici crnom bojom.
English: • medicines to treat cancer (e.g. bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib, tamoxifen) or nausea/vomiting with cancer treatment (e.g. fosaprepitant)
Croatian: • lijekove za liječenje raka (npr. bikalutamid, lapatinib, metotreksat, nilotinib, pazopanib,
English: The capsule is an orange cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “10 mg” on body and “A733” on cap.
Croatian: Tvrda kapsula veličine 19,4 mm sastoji se od narančaste kapice i bijelog tijela s, s otisnutim oznakama crnom tintom „10 mg“ na tijelu i „A733“ na kapici.
English: You can help by reporting any side effects you may get.
Croatian: Prijavom svih sumnji na nuspojave i Vi možete pomoći.
English: Your doctor will give you a blood test to check your liver before you start taking these capsules, if your dose is increased, and regularly during treatment.
Croatian: Vam se povećava doza te redovito tijekom liječenja, liječnik će Vas uputiti da napravite krvne pretrage radi provjere funkcije jetre.
English: The capsule is a yellow cap/white body hard capsule of 23.4 mm, printed with black ink imprinted with “40 mg” on body and “A733” on cap.
Croatian: Tvrda kapsula veličine 23,4 mm sastoji se od žute kapice i bijelog tijela, s otisnutim oznakama crnom tintom „40 mg“ na tijelu i „A733“ na kapici.
English: Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
Croatian: Lojuxta 30 mg tvrde kapsule želatina titanijev dioksid (E171) željezov oksid, crveni (172) željezov oksid, žuti (172)
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva Manje često mjehurići na koži suha koža hiperhidroza
English: Grapefruit juice must be omitted from the diet while patients are treated with Lojuxta.
Croatian: Za vrijeme liječenja Lojuxtom bolesnici moraju iz prehrane izbaciti sok od grejpa.
English: General disorders and administrative site conditions
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: • nausea and vomiting (feeling or being sick)
Croatian: • mučnina i povraćanje
English: Lower gastrointestinal haemorrhage Reflux oesophagitis
Croatian: Svjetski opservacijski registar procjene lomitapida
English: Defaecation urgency Eructation
Croatian: Prijavljivanje nuspojava
English: Pharyngeal lesion Upper-airway cough syndrome
Croatian: Manje često faringealna lezija sindrom gornjih dišnih puteva kao uzrok kašlja
English: Eructation
Croatian: Doziranje
English: Blood alkaline phosphatase increased Blood potassium decreased Carotene decreased International normalised ratio abnormal
Croatian: Često povišen INR povišena razina alkalne fosfataze u krvi smanjena razina kalija u krvi smanjeni karoten poremećen INR poremećeni nalazi pretraga funkcije jetre produljeno protrombinsko vrijeme povišene transaminaze smanjen vitamin E smanjen vitamin
English: Pain in extremity Joint swelling Muscle twitching
Croatian: Manje često artralgija mialgija bol u udovima oticanje zglobova trzanje mišića
English: Pyrexia
Croatian: • proljev
English: • The Summary of Product Characteristics
Croatian: • sažetak opisa svojstava lijeka
English: Titanium dioxide (E171)
Croatian: Lojuxta 20 mg tvrde kapsule želatina titanijev dioksid (E171)
English: Lojuxta 40 mg, 60 mg hard capsules Gelatin
Croatian: Lojuxta 40 mg tvrde kapsule Lojuxta 60 mg tvrde kapsule
English: Hepatic impairment
Croatian: Insuficijencija bubrega
English: Ecchymosis Papule
Croatian: • mišićni grčevi
English: This summary was last updated in 01-2017.
Croatian: Ovaj sažetak je posljednji put ažuriran u 01. 2017.
English: The full EPAR and risk management plan summary for Jardiance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR i sažetak plana upravljanja rizikom za lijek Jardiance nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: On average, patients in the study were followed up for 3.1 years.
Croatian: Bolesnike koji su sudjelovali u ispitivanju u prosjeku se pratilo tijekom razdoblja od 3,1 godine.
English: The recommended starting dose is 10 mg once a day, which can be increased if necessary to 25 mg daily in suitable patients.
Croatian: Preporučena početna doza iznosi 10 mg jednom na dan što se, prema potrebi, može povećati na 25 mg na dan kod odgovarajućih bolesnika.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jardiance on 22 May 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Jardiance na snazi u Europskoj uniji od 22. svibnja 2014.
English: In those receiving Jardiance, cardiovascular events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of patients receiving placebo.
Croatian: Kod bolesnika koji su primali lijek Jardiance kardiovaskularni događaji nastupili su u 10,5 % (490 od 4 687) bolesnika u usporedbi s 12,1 % (282 od 2 333) bolesnika koji su primali placebo.
English: Other information about Jardiance
Croatian: Ostale informacije o lijeku Jardiance
English: This is a summary of the European public assessment report (EPAR) for Jardiance.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Jardiance.
English: This leads to high levels of glucose in the blood.
Croatian: To dovodi do visoke razine glukoze u krvi.
English: Supportive evidence was provided from a further six studies.
Croatian: Dostavljeni su podupirući dokazi iz dodatnih šest ispitivanja.
English: What measures are being taken to ensure the safe and effective use of Jardiance?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Jardiance?
English: The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease.
Croatian: Glavna mjera djelotvornosti bila je prva pojava jednog od tri teška kardiovaskularna događaja: moždani udar, srčani udar ili smrt izazvana kardiovaskularnom bolešću.
English: What is Jardiance and what is it used for?
Croatian: Što je Jardiance i za što se koristi?
English: Why is Jardiance approved?
Croatian: Zašto je lijek Jardiance odobren?
English: Jardiance is available as tablets (10 and 25 mg) and can only be obtained with a prescription.
Croatian: Lijek Jardiance dostupan je u tabletama (od 10 i 25 mg) i izdaje se samo na recept.
English: A beneficial effect of Jardiance on blood glucose has been shown in four main studies involving over 2,700 patients.
Croatian: Koristan učinak lijeka Jardiance na glukozu u krvi dokazan je u četiri glavna ispitivanja koja su obuhvatila više od 2 700 bolesnika.
English: There was also supportive evidence suggesting benefit when the medicine was combined with insulin.
Croatian: Postojali su također podupirući dokazi koji su ukazivali na korist kad se lijek kombinirao s inzulinom.
English: It is not intended to provide practical advice on how to use Jardiance.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Jardiance.
English: Some of these were continuations of the main studies, and suggested that the benefits of the medicine continued with longer therapy.
Croatian: Neka od tih ispitivanja bila su nastavci glavnih ispitivanja i pokazala su da se koristi lijeka nastavljaju uz dulju terapiju.
English: When blood sugar levels decrease, HbA1C levels also decrease.
Croatian: Kada se razine šećera u krvi smanje, smanje se i razine tvari HbA1c.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Jardiance's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi lijeka Jardiance nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: It can also be used as an ‘add-on' to other diabetes medicines.
Croatian: Također se može primjenjivati kao dodatak drugim lijekovima protiv dijabetesa.
English: What are the risks associated with Jardiance?
Croatian: Koji su rizici povezani s lijekom Jardiance?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jardiance have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Jardiance nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The study involved patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack and stroke).
Croatian: U to su ispitivanje bili uključeni bolesnici s dijabetesom tipa 2 koji su već imali kardiovaskularne bolesti (npr. anginu te srčani i moždani udar).
English: Another main study showed that adding Jardiance to usual treatment reduced adverse cardiovascular (heart and blood vessels) effects.
Croatian: Još jedno glavno ispitivanje pokazalo je da su se dodavanjem lijeka Jardiance uobičajenoj terapiji smanjili nepovoljni kardiovaskularni učinci (učinci na srce i krvne žile).
English: Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Croatian: Dijabetes tipa 2 bolest je pri kojoj tijelo ne proizvodi dovoljno inzulina za kontrolu razine glukoze (šećera) u krvi ili pri kojoj tijelo ne može učinkovito koristiti inzulin.
English: If Jardiance is used in combination with insulin or sulphonylureas (medicines that make the body produce insulin), the doses of these may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).
Croatian: Ako se Jardiance koristi u kombinaciji s inzulinom ili sulfonilurejama (lijekovima koji tijelu omogućuju proizvodnju inzulina), njihove doze će možda trebati smanjiti kako bi se smanjio rizik od hipoglikemije (niske razine šećera u krvi).
English: Jardiance was compared with placebo (a dummy treatment) when used alone or added to treatment with other diabetes medicines (metformin, pioglitazone, or metformin plus either pioglitazone or another type of diabetes medicine called a sulphonylurea).
Croatian: Jardiance je uspoređen s placebom (prividnim liječenjem) kada se koristio sam ili kao dodatak drugim lijekovima protiv dijabetesa (metforminom, pioglitazonom ili metforminom u kombinaciji s pioglitazonom ili drugom vrstom lijeka protiv dijabetesa pod nazivom sulfonilureja).
English: Jardiance is a diabetes medicine used with diet and exercise to treat adults whose type 2 diabetes is not satisfactorily controlled.
Croatian: Jardiance je lijek protiv dijabetesa koji se koristi uz dijetu i tjelovježbu u liječenju odraslih osoba u kojih dijabetes tipa 2 nije kontroliran na zadovoljavajući način.
English: The main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, after 24 weeks of treatment.
Croatian: Glavna mjera djelotvornosti bila je promjena razine glikoziliranog hemoglobina (HbA1c) u krvi, što ukazuje na to koliko se uspješno kontrolira glukoza u krvi, nakon 24 tjedna terapije.
English: What benefits of Jardiance have been shown in studies?
Croatian: Koje su koristi lijeka Jardiance dokazane u ispitivanjima?
English: The most common side effect with Jardiance (which may affect more than 1 in 10 people) is hypoglycaemia (low blood sugar) when the medicine is taken with a sulphonylurea or insulin.
Croatian: Najčešća nuspojava lijeka Jardiance (može se javiti u više od 1 na 10 osoba) je hipoglikemija (niska razina šećera u krvi) kad se lijek uzima sa sulfonilurejom ili inzulinom.
English: Because Jardiance relies on the working of the kidneys for its effect, treatment with this medicine is not recommended in patients with moderately or severely impaired kidney function.
Croatian: Budući da učinak lijeka Jardiance ovisi o funkciji bubrega, liječenje njime ne preporučuje se u bolesnika s umjerenim ili teškim oštećenjem funkcije bubrega.
English: In addition, the results indicated that Jardiance treatment was associated with a beneficial fall in body weight and blood pressure.
Croatian: Nadalje, rezultati ukazuju na to da je terapija lijekom Jardiance povezana s korisnim snižavanjem tjelesne težine i krvnoga tlaka.
English: Jardiance contains the active substance empagliflozin.
Croatian: Lijek Jardiance sadrži djelatnu tvar empagliflozin.
English: For more information about treatment with Jardiance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Jardiance pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Jardiance can be used on its own in patients who cannot take metformin (another diabetes medicine).
Croatian: Jardiance se može koristiti kao monoterapija u bolesnika koji ne mogu uzimati metformin (drugi lijek protiv dijabetesa).
English: However, the blood glucose lowering effects of the medicine are lower in patients with kidney impairment, and the CHMP recommended that the medicine not be used in some patients, depending on their kidney function.
Croatian: Međutim, koristi koje lijek ima na smanjivanje razine glukoze u krvi bile su manje u bolesnika s oštećenjem bubrega te je CHMP preporučio da se lijek ne koristi u nekih bolesnika, ovisno o funkciji njihovih bubrega.