natgillin/translations-raw huggingface dataset:
Vitekta 150 mg [Outer packaging only]
16. PODACI NA BRAILLEOVOM PISMU Vitekta 150 mg [samo vanjsko pakiranje]
Vitekta film-coated tablets are green, triangle-shaped tablets, debossed on one side with “GSI” and “150” on the other side of the tablet.
Vitekta filmom obložene tablete su zelene tablete u obliku trokuta, s utisnutom oznakom „GSI“ na jednoj strani i brojem „150“ na drugoj strani tablete.
Lopinavir/Ritonavir has been shown to significantly increase the plasma concentrations of elvitegravir.
Pokazalo se da lopinavir/ritonavir značajno povećavaju koncentracije elvitegravira u plazmi.
No clinically relevant differences in elvitegravir pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira između ispitanika s umjerenim oštećenjem funkcije jetre i zdravih ispitanika.
Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with hepatitis B virus (HBV).
U cilju optimalnog liječenja HIV infekcije u pacijenata koji su istovremeno zaraženi virusom hepatitisa B (HBV), liječnici se moraju pridržavati trenutačno važećih smjernica za liječenje HIV-a.
No clinically relevant pharmacokinetic differences due to gender have been identified for boosted
Klinički značajne farmakokinetičke razlike vezane uz spol nisu ustanovljene za pojačani elvitegravir.
Plasma concentrations of OATP substrates are not expected to change upon co-administration of elvitegravir.
Koncentracije supstrata polipeptida koji transportira organske anione (OATP) u plazmi očekivano se ne mijenjaju nakon istovremene primjene elvitegravira.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 85 mg of elvitegravir.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 85 mg elvitegravira.
Elvitegravir (simultaneous
Elvitegravir (istodobna primjena antacida):
• cobicistat
• kobicistat
Refer to the package leaflet for Vitekta 150 mg tablets.
Pročitajte Uputu o lijeku za Vitekta 150 mg tablete.
Elvitegravir (125 mg once daily)
Elvitegravir (125 mg jedanput na dan)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of elvitegravir.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 150 mg elvitegravira.
Vitekta 85 mg film-coated tablets Elvitegravir
Vitekta 85 mg filmom obložene tablete elvitegravir
It is recommended that the international normalised ratio (INR) be monitored upon co-administration of Vitekta.
U slučaju istovremene primjene lijeka Vitekta preporučuje se praćenje međunarodnog normaliziranog omjera (INR).
Vitekta 150 mg film-coated tablets Elvitegravir
Vitekta 150 mg filmom obložene tablete elvitegravir
Cmin: ↔ Abacavir: AUC: ↔ Cmax: ↔
Cmin: ↔ Abakavir: AUC: ↔ Cmax: ↔
Vitekta film-coated tablets are green, pentagon-shaped tablets, debossed on one side with “GSI” and “85” on the other side of the tablet.
Vitekta filmom obložene tablete su zelene tablete u obliku peterokuta, s utisnutom oznakom „GSI“ na jednoj strani i brojem „85“ na drugoj strani tablete.
Vitekta 85 mg film-coated tablets
Vitekta 85 mg filmom obložene tablete
 If you think that you may have any of these side effects, talk to your doctor.
Ako mislite da imate neku od ovih nuspojava, obavijestite svog liječnika.
When used in combination with atazanavir/ritonavir and lopinavir/ritonavir, the dose of Vitekta should be decreased from 150 mg once daily to 85 mg once daily (see section 4.2).
Kada se primjenjuje u kombinaciji s atazanavirom/ritonavirom i lopinavirom/ritonavirom, doza lijeka Vitekta mora se smanjiti s 150 mg jedanput na dan na 85 mg jedanput na dan (vidjeti dio 4.2).
There are no data available to make dosing recommendations for co-administration with other doses of darunavir (see section 4.2).
Ne postoje dostupni podaci o preporukama doziranja za istovremenu primjenu s drugim dozama darunavira (vidjeti dio 4.2).
Look out for signs of inflammation or infection soon after you start taking Vitekta.
Odmah nakon početka uzimanja lijeka Vitekta pazite na znakove upale ili infekcije.
No dose adjustment is required when Vitekta is co-administered with ketoconazole.
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s ketokonazolom.
When used in combination with atazanavir, the dose of Vitekta should be 85 mg once daily.
Kada se primjenjuje u kombinaciji s atazanavirom, doza lijeka Vitekta mora biti 85 mg jedanput na dan.
When used in combination with darunavir, the dose of Vitekta should be 150 mg once daily.
Kada se primjenjuje u kombinaciji s darunavirom, doza lijeka Vitekta mora biti 150 mg jedanput na dan.
No dose adjustment of Vitekta is required for patients with renal impairment.
Nije potrebna prilagodba doze lijeka Vitekta u pacijenata s oštećenjem funkcije bubrega.
Women of childbearing potential / contraception in males and females The use of Vitekta must be accompanied by the use of effective contraception (see sections 4.4 and 4.5).
Uz primjenu lijeka Vitekta mora se koristiti učinkovita kontracepcija (vidjeti dijelove 4.4 i 4.5).
Please refer to the Summary of Product Characteristics for Vitekta 85 mg
Pročitajte Sažetak opisa svojstava lijeka za Vitekta 85 mg
Vitekta 150 mg film-coated tablets
Vitekta 150 mg filmom obložene tablete
Gilead Sciences International Limited Cambridge
Gilead Sciences Intl Ltd Cambridge
No dose adjustment of Vitekta is required in patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B) (see sections 4.2 and 5.2).
U pacijenata s blagim (Child-Pugh stadij A) i umjerenim (Child-Pugh stadij B) oštećenjem jetre nije potrebna prilagodba doze lijeka Vitekta (vidjeti dijelove 4.2 i 5.2).
-21.4% (-73.6% to 30.7%)
1,6% (-33,0% do 36,2%) -21,4% (-73,6% do 30,7%)
Although limited by the small number of female subjects in study GS-US-183-0145, subgroup analysis by gender showed that the rates of virologic success in female subjects at weeks 48 and 96 (HIV-1 RNA < 50 copies/mL) were numerically lower in the elvitegravir treatment arm than in the raltegravir treatment arm. Virologic success rates at week 48 for elvitegravir and raltegravir were 47.5% (28/59) and 62.7% (42/67) (difference: -12.3% [95% CI: -30.1% to 5.5%]), respectively, for female subjects, and 62.3% (182/292) and 56.3% (160/284) (difference: 5.3% [95% CI: -2.5% to 13.2%]), respectively, for male subjects.
Stope virološkog uspjeha u 48. tjednu za elvitegravir i raltegravir bile su 47,5% (28/59), odnosno 62,7% (42/67) (razlika: -12,3% [95% CI: -30,1% do 5,5%]) za ispitanice, a za ispitanike 62,3% (182/292), odnosno 56,3% (160/284) (razlika: 5,3% [95% CI: -2,5% do 13,2%]).
-11.1% (-45.7% to 23.4%)
-11,1% (-45,7% do 23,4%) 7,1% (-47,1% do 61,4%)
Elvitegravir
Nuspojava
When used in combination with lopinavir/ritonavir, the dose of Vitekta should be 85 mg once daily.
Kada se primjenjuje u kombinaciji s lopinavirom/ritonavirom, doza lijeka Vitekta mora biti 85 mg jedanput na dan.
When used in combination with fosamprenavir, the dose of Vitekta should be 150 mg once daily.
Kada se primjenjuje u kombinaciji s fosamprenavirom, doza lijeka Vitekta mora biti 150 mg jedanput na dan.
• atazanavir and ritonavir
• atazanavir i ritonavir
There are no data available to make dosing recommendations for co-administration with other doses of atazanavir (see section 4.2).
Ne postoje dostupni podaci o preporukama doziranja za istovremenu primjenu s drugim dozama atazanavira (vidjeti dio 4.2).
Refer to the package leaflet for Vitekta 85 mg tablets.
Pročitajte Sažetak opisa svojstava lijeka za Vitekta 85 mg tablete.
Ketoconazole (200 mg twice daily) Elvitegravir (150 mg once daily) Ritonavir (100 mg once daily)
Ketokonazol (200 mg dvaput na Elvitegravir (150 mg jedanput na Ritonavir (100 mg jedanput na dan)
Each film-coated tablet contains 85 mg elvitegravir.
Jedna filmom obložena tableta sadrži 85 mg elvitegravira.
No dose adjustment is required when Vitekta is co-administered with famotidine.
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s famotidinom.
MARKETING AUTHORISATION HOLDER
Sažetak profila sigurnosti primjene
• fosamprenavir and ritonavir
• fosamprenavir i ritonavir
No dose adjustment is required when Vitekta is co-administered with etravirine.
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s etravirinom.
Co-administration of Vitekta with moderate CYP3A inducers (including, but not limited to, efavirenz and bosentan) is not
Ne preporučuje se istovremena primjena lijeka Vitekta i umjerenih induktora CYP3A (uključujući, bez ograničenja, efavirenz i bosentan) (vidjeti dio 4.5).
There are no data available to make dosing recommendations for co-administration with other doses of fosamprenavir (see section 4.2).
Ne postoje dostupni podaci o preporukama doziranja za istovremenu primjenu s drugim dozama fosamprenavira (vidjeti dio 4.2).
Each film-coated tablet contains 150 mg elvitegravir.
Jedna filmom obložena tableta sadrži 150 mg elvitegravira.
No dose adjustment is required when Vitekta is co-administered with methadone.
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s metadonom.
No dose adjustment is required when Vitekta is co-administered with buprenorphine/naloxone.
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s buprenorfinom/naloksonom.
Elvitegravir-resistant viruses show cross-resistance to the integrase strand transfer inhibitor raltegravir
Virusi rezistentni na elvitegravir u većini slučaja pokazuju križnu rezistenciju na raltegravir, inhibitor prijenosa lanca integraze (vidjeti dio 5.1).
• darunavir and ritonavir
• darunavir i ritonavir
Rosuvastatin (10 mg single dose) Elvitegravir (150 mg once daily) Cobicistat (150 mg once daily)
Rosuvastatin (jednokratna doza od Elvitegravir (150 mg jedanput na Kobicistat (150 mg jedanput na
The active substance elvitegravir is persistent in the environment.
Djelatna tvar elvitegravir nije razgradiva u okolišu.
Slovenská republika Gilead Sciences International Ltd Tel: + 44 (0) 20 7136 8820
Slovenská republika Gilead Sciences International Ltd Tel: + 44 (0) 20 7136 8820 Suomi/Finland
Elvitegravir (85 mg once daily) Atazanavir (300 mg once daily) Ritonavir (100 mg once daily)
Atazanavir (300 mg jedanput na Elvitegravir (85 mg jedanput na Ritonavir (100 mg jedanput na
Signs of osteonecrosis are: - joint stiffness - joint aches and pains (especially of the hip, knee and shoulder) - difficulty with movement.
Znakovi tupi bolovi i probadanje u zglobovima (osobito u kuku, koljenu i ramenu), Ako primijetite bilo koji od ovih simptoma, obavijestite svog liječnika.
A dose of 150 mg is recommended: If you are taking Vitekta with:
Ako lijek Vitekta uzimate s:
Lopinavir/Ritonavir has been shown to significantly increase the plasma concentrations of
Pokazalo se da atazanavir/ritonavir značajno povećavaju koncentracije
Effects on drug levels Mean percent change in AUC,
Učinci na razine lijekova Srednja vrijednost postotka promjene AUC, Cmax, Cmin
Due to inhibition of CYP3A by ritonavir, 25-O-desacetyl-rifabutin exposure is increased.
Izloženost 25-O-desacetilrifabutinu je povećana zbog inhibicije CYP3A ritonavirom.
No dose adjustment is required when Vitekta is co-administered with maraviroc.
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s maravirokom.
No dose adjustment is required when Vitekta is co-administered with rosuvastatin.
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s rosuvastatinom.
§Due to inhibition of CYP3A by ritonavir, 25-O-desacetyl-rifabutin exposure is increased.
§Izloženost 25-O-desacetilrifabutinu je povećana zbog inhibicije CYP3A ritonavirom.
Suomi/Finland Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849
Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849 Sverige
No dose adjustment is required when Vitekta is co-administered with omeprazole.
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s omeprazolom.
Tenofovir disoproxil fumarate (300 mg once daily) Emtricitabine (200 mg once daily) Elvitegravir (50 mg once daily)
Tenofovirdizoproksilfumarat (300 mg jedanput na dan) Emtricitabin (200 mg jedanput na dan)
No dose adjustment is required when Vitekta is co-administered with zidovudine.
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje sa zidovudinom.
Famotidine (40 mg once daily) Elvitegravir (150 mg once daily) Cobicistat (150 mg once daily)
Famotidin (40 mg jedanput na dan) Elvitegravir (150 mg jedanput na
§Due to inhibition of CYP3A by ritonavir, ketoconazole exposure is increased.
§Izloženost ketokonazolu je povećana zbog inhibicije CYP3A ritonavirom.
No dose adjustment is required when Vitekta is co-administered with abacavir.
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s abakavirom.
Fosamprenavir (700 mg twice daily)
Ritonavir (200 mg dvaput na dan)
Elvitegravir (50 mg once daily) Ritonavir (100 mg once daily)
Elvitegravir (200 mg jedanput na Ritonavir (100 mg jedanput na
CCR5 antagonists Maraviroc (150 mg twice daily) Elvitegravir (150 mg once daily) Ritonavir (100 mg once daily)
Maravirok (150 mg dvaput na dan) Elvitegravir (150 mg jedanput na dan)
A dose of 85 mg is recommended: If you are taking Vitekta with:
Preporučena doza je 85 mg:
Skin and subcutaneous tissue disorders: General disorders and administration site conditions:
Opći poremećaji i reakcije na mjestu primjene:
§Due to inhibition of CYP3A by ritonavir, maraviroc exposure is significantly increased.
Izloženost maraviroku značajno je povećana zbog inhibicije CYP3A ritonavirom.
 If you get any side effects, talk to your doctor or pharmacist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
Abacavir (600 mg once daily) Elvitegravir (200 mg once daily) Ritonavir (100 mg once daily)
Fosamprenavir (700 mg dvaput na Elvitegravir (125 mg jedanput na Ritonavir (100 mg dvaput na dan)
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE
Nervous system disorders:
Oštećenje funkcije bubrega
Elvitegravir (150 mg once daily) Cobicistat (150 mg once daily)
Elvitegravir (150 mg jedanput na dan)
The in vitro antiviral activity of elvitegravir when combined with antiretroviral drugs from the nucleos(t)ide reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI),
Nenukleozidni inhibitori reverzne transkriptaze (NNRTI)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Gilead Sciences Intl Ltd
Nositelj odobrenja za stavljanje lijeka u promet Gilead Sciences International Limited
If you notice signs of inflammation or infection, tell your doctor at once.
Odmah obavijestite svog liječnika ako primijetite znakove upale ili infekcije.
No dose adjustment is required when Vitekta is co-administered with stavudine.
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje sa stavudinom.
What Invokana is and what it is used for
Što je Invokana i za što se koristi
See section 3, “Taking this medicine”.
Pogledajte dio 3, „Uzimanje ovog lijeka”.
• fast and deep breathing
• ubrzano i duboko disanje
These differences are not considered to be clinically meaningful.
Ove razlike se ne smatraju klinički značajnima.
If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.
U slučaju da propusti dozu, bolesnik ju treba uzeti čim se sjeti; međutim, ne smije se uzeti dvostruka doza u istom danu.
ATC code: A10BK02.
ATK oznaka: A10BK02.
More information is given below in “Other medicines and Invokana”.
Više informacija možete pronaći niže, u dijelu „Drugi lijekovi i Invokana“.
Possible signs of losing too much fluid from your body are listed in section 4.
Mogući znakovi prevelikog gubitka tjelesne tekućine navedeni su u dijelu 4.
This reduces the amount of sugar in your blood and can help prevent heart disease.
To smanjuje količinu šećera u Vašoj krvi i može pomoći spriječiti razvoj srčane bolesti.
• if you have ever had serious heart disease or if you have had a stroke.
• ako ste ikada imali ozbiljnu bolest srca ili ako ste ikada imali moždani udar.
• about what you can do to prevent dehydration (see section 4 for signs of dehydration).
• vezano uz to što možete poduzeti radi sprječavanja dehidracije (pogledajte dio 4 za znakove dehidracije)
Date of first authorisation: 15 November 2013 Date of latest renewal: 26 July 2018
Datum posljednje obnove odobrenja: 26. srpnja 2018.
The doctor may decide to temporarily or permanently stop the treatment with Invokana.
Vaš liječnik može odlučiti privremeno ili trajno prekinuti Vaše liječenje lijekom Invokana.
• if you have type 1 diabetes because Invokana should not be used to treat this condition.
• ako imate šećernu bolest tipa 1 jer se Invokana ne smije uzimati za liječenje ovog stanja.
If you take more of this medicine than you should, talk to a doctor or go to the nearest hospital immediately.
Ako uzmete više ovog lijeka nego što biste trebali, obratite se liječniku ili otiđite odmah u najbližu bolnicu.
• increased levels of “ketone bodies” in your urine or blood
• povišene razine „ketonskih tijela“ u mokraći ili krvi
The racial distribution was 72% White, 16% Asian, 5% Black, and 8% other groups.
Raspodjela po rasama bila je 72% bijelaca, 16% azijata, 5% crnaca i 8% ostalih skupina.
Stop taking Invokana and talk to a doctor or go to the nearest hospital immediately if you have any of the following serious side effects:
Prestanite uzimati lijek Invokana i obratite se liječniku ili odmah otiđite u najbližu bolnicu ako imate bilo koju od sljedećih ozbiljnih nuspojava:
Each MACE component positively contributed to the overall composite, as shown in Figure 2.
Svaki je pojedinačna sastavnica MACE događaja pozitivno pridonijela ukupnoj kompozitnoj mjeri ishoda, što je prikazano na Slici 2.
Balanitis or balanoposthitis b,l
Balanitis ili balanopostitis b,l
Figure 1: Time to First Occurrence of MACE
Vrijeme do prvog nastupa MACE događaja
Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Katregorije učestalosti su definirane prema sljedećem sporazumu: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
• unusual sleepiness or tiredness
• neuobičajena pospanost ili umor
Kidney function Your kidneys will be tested by a blood test before you start taking and while you are on this medicine.
Funkcija Vaših bubrega bit će provjeravana krvnim pretragama prije početka uzimanja i dok uzimate ovaj lijek.
Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2):
Dijabetička ketoacidoza (rijetko, može se javiti u do 1 na 1000 osoba) Ovo su znakovi dijabetičke ketoacidoze (također pogledajte dio 2):
• kidney failure (mainly as a consequence of loss of too much fluid from your body).
• zatajenje bubrega (većinom kao posljedica prevelikog gubitka tekućine iz Vašeg tijela)
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.
U slučaju predoziranja, opravdano je primijeniti uobičajene potporne mjere, npr. ukloniti neapsorbirani lijek iz gastrointestinalnog sustava, vršiti klinički nadzor, te po potrebi uvesti kliničke mjere.
canagliflozin N = 5790
Kanagliflozin N = 5790
• The starting dose of Invokana is one 100 mg tablet each day.
• Početna doza lijeka Invokana je jedna tableta od 100 mg svaki dan.
Diabetic ketoacidosis b,h
Dijabetička ketoacidoza b,h
Invokana is available in PVC/aluminium perforated unit dose blisters.
Invokana je dostupna u PVC/aluminij perforiranim blisterima s jediničnim dozama.
Before initiating Invokana, consider factors in the patient history that may increase the risk for amputation.
Prije uvođenja lijeka Invokana potrebno je razmotriti faktore iz bolesnikove anamneze koji bi mogli povećati rizik od amputacije.
Moderate increases (generally < 400 mL to 500 mL) in daily urine volume were seen that attenuated over several days of dosing.
Uvidjelo se da su umjerena povišenja (uglavnom < 400 ml do 500 ml) u dnevnom volumenu mokraće umanjena kroz nekoliko dana doziranja.
Two hundred eleven (211) patients from the clinical study in older patients participated in a body composition substudy using DXA body composition analysis.
Dvjesto i jedanaest (211) bolesnika iz kliničkih ispitivanja sa starijim bolesnicima sudjelovali su u podispitivanju sastava tijela korištenjem DXA analize sastava tijela.
Figure 2: Treatment Effect for the Primary Composite Endpoint and its Components
Slika 2: Utjecaj liječenja za primarnu kompozitnu mjeru ishoda i njezine pojedinačne sastavnice
Medicinal product/Laboratory test interference
Interferencija s lijekovima/laboratorijskim pretragama
Treatment with canagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised.
Liječenje kanagliflozinom može se ponovno započeti nakon što vrijednosti razine ketona ponovo postanu normalne i bolesnikovo stanje je stabilizirano.
• if you have severe kidney problems or are on dialysis.
• ako imate teške probleme s bubrezima ili ste na dijalizi.
• if you have severe liver problems.
• ako imate teške probleme s jetrom.
Related to bone fracture; see description of AR below.
Povezano s frakturom kostiju; vidjeti opis nuspojave u nastavku..
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications - in addition to other medicinal products for the treatment of diabetes.
- kao monoterapija kada se primjena metformina ne smatra prikladnom zbog nepodnošenja ili kontraindikacija - kao dodatak drugim lijekovima za liječenje dijabetesa
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
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 ispitivanja koji se odnose na kombinirane terapije, učinke na regulaciju glikemije i kardiovaskularne događaje, te ispitivane populacije vidjeti dijelove 4.4, 4.5 i 5.1.
Due to its mechanism of action, canagliflozin, by increasing urinary glucose excretion (UGE) induces an osmotic diuresis, which may reduce intravascular volume and decrease blood pressure (see section 5.1).
Zbog svog mehanizma djelovanja, kanagliflozin, povećavajući ekskreciju glukoze urinom (UGE) inducira osmotsku diurezu, što može reducirati intravaskularni volumen i smanjiti krvni tlak (vidjeti dio 5.1).
• if you experience 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, talk to a doctor or go to the nearest hospital immediately.
• ako iskusite nagli gubitak tjelesne težine, osjećaj mučnine ili povraćanje, bol u trbuhu, prekomjernu žeđ, ubrzano i duboko disanje, smetenost, neuobičajenu pospanost ili umor, zadah slatkog mirisa, slatki ili metalni okus u ustima ili drugačiji miris mokraće ili znoja, odmah razgovarajte sa svojim liječnikom ili odmah otiđite u najbližu bolnicu.