natgillin/translations-raw huggingface dataset:
Results at Week 24 (LOCFa) of a placebo-controlled study of dapagliflozin as monotherapy
Rezultati s placebom kontrolirane študije dapagliflozina kot monoterapije po 24 tednih (LOCF
Not applicable.
Ni posebnih zahtev.
Forxiga 5 mg film-coated tablets Forxiga 10 mg film-coated tablets dapagliflozin
Forxiga 5 mg filmsko obložene tablete Forxiga 10 mg filmsko obložene tablete dapagliflozin
Bone mineral density measurements in patients with normal or mildly impaired renal function did not indicate bone loss over a treatment period of two years.
Poročali so o majhnih povečanjih vrednosti PTH v serumu, ki so bila izrazitejša pri preiskovancih z večjo izhodiščno koncentracijo PTH. Merjenja mineralne kostne gostote pri bolnikih z normalno ali blago okvaro ledvic v dveletnem obdobju zdravljenja niso pokazala izgube kostne mase.
Mean changes from baseline in haematocrit were 2.30% for dapagliflozin 10 mg versus -0.33% for placebo.
Povprečni odstotek spremembe hematokrita od izhodišča je bil 2,30 % z 10 mg dapagliflozina in -0,33 % s placebom.
HbA1c < 7%
HbA1c < 7 % (LOCF)
NAME OF THE MARKETING AUTHORISATION HOLDER AstraZeneca AB
Imetnik dovoljenja za promet z zdravilom AstraZeneca AB
Diuretics
Dojenje
Use in patients with hepatic impairment
Uporaba pri bolnikih z okvaro jeter
Dapagliflozin 10 mg
Monoterapija dapagliflozin 10 mg placebo b
Add-on combination therapy
Dodatek h kombiniranemu zdravljenju
In an add-on to insulin study, episodes of major hypoglycaemia were reported in 0.5% and 1.0% of subjects treated with dapagliflozin 10 mg plus insulin at Weeks 24 and 104, respectively, and in 0.5% of subjects treated with placebo plus insulin groups at Weeks 24 and 104.
V študiji dodatka k insulinu so hude hipoglikemije do 24. oziroma 104. tedna zabeležili pri 0,5 % oziroma 1,0 % prejemnikov kombinacije 10 mg dapagliflozina in insulina ter pri 0,5 % prejemnikov kombinacije placeba in insulina.
Use in patients with renal impairment
Uporaba pri bolnikih z okvaro ledvic
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350
Filmska obloga polivinilalkohol (E1203) titanov dioksid (E171) makrogol 3350 smukec (E553b) železov oksid, rumeni (E172)
• Your doctor may start you on a 5 mg dose if you have a liver problem.
• Če imate težave z jetri, vam zdravnik lahko predpiše začetni odmerek 5 mg.
adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7% and 0.8% of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4).
Pri osebah, starih ≥ 65 let, so o pomanjkanju volumna kot neželenemu učinku, najpogosteje poročali kot o hipotenziji in jo zabeležili pri 1,7 % oseb, ki so prejemale dapagliflozin in pri 0,8 % oseb, ki so prejemale placebo (glejte poglavje 4.4).
(95% CI) Subjects (%) achieving: HbA1c < 7% (LOCF)d Adjusted for baseline Body weight (kg) (LOCF)d Baseline (mean) Change from baselinec Difference from placeboc (95% CI) 1glimepiride 4 mg/day; 2Metformin (immediate- or extended-release formulations) ≥1500 mg/day plus maximum tolerated dose, which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrollment.
2Metformin (oblike s takojšnjim ali podaljšanim sproščanjem) ≥ 1500 mg/dan ter največji tolerirani odmerek (ki mora biti vsaj polovičen maksimalni odmerek) sulfonilsečnine vsaj 8 tednov pred zajetjem v študijo.
LIST OF EXCIPIENTS Contains lactose.
Zdravilo Forxiga vsebuje laktozo
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 10 mg dapagliflozina.
The mean change from baseline in HbA1c at 24 weeks was -0.44% and -0.33%, for dapagliflozin 10 mg and placebo, respectively.
Povprečna sprememba HbA1c od izhodišča za 10 mg dapagliflozina je bila 24. teden -0,44 % in -0,33 % za placebo.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 5 mg dapagliflozina.
Each Forxiga 5 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Ena tableta zdravila Forxiga 5 mg filmsko obložene tablete vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 5 mg dapagliflozina.
Stop taking Forxiga and see a doctor as soon as possible if you notice any of the following serious side effects:
Če opazite katerega od naslednjih resnih neželenih učinkov, prenehajte z jemanjem zdravila Forxiga in čim prej obiščite zdravnika:
• dizziness
• omotica
• genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour)
• okužba spolovil (glivice) na spolnem udu ali v nožnici (med znaki so lahko draženje, srbenje,
Each Forxiga 10 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Ena tableta zdravila Forxiga 10 mg filmsko obložene tablete vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 10 mg dapagliflozina.
Contact your doctor as soon as possible if you have any of the following side effects:
Čim prej se posvetujte z zdravnikom, če imate katerega od naslednjih neželenih učinkov: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov):
Evidence of sustained glucose excretion was seen in subjects with type 2 diabetes mellitus given dapagliflozin 10 mg/day for up to 2 years.
Pri osebah s sladkorno boleznijo tipa 2, ki so prejemale 10 mg dapagliflozina na dan, do 2 leti, so ugotovili ohranjeno izločanje glukoze.
Dizziness
Malignomi
Results at Week 52 (LOCFa) in an active-controlled study comparing dapagliflozin to glipizide as add-on to metformin
Rezultati z zdravilno učinkovino kontrolirane študije, ki je primerjala dapagliflozin z glipizidom kot dodatkom k metforminu po 52 tednih (LOCF
Talk to your doctor if you would like to or are breast-feeding before taking this medicine.
Če dojite ali želite dojiti, se posvetujte z zdravnikom pred jemanjem tega zdravila.
• Keep this medicine out of the sight and reach of children.
• Zdravilo shranjujte nedosegljivo otrokom!
• Forxiga 5 mg film-coated tablets are yellow and round with diameter of 0.7 cm.
• Tablete zdravila Forxiga 5 mg filmsko obložene tablete so rumene barve, okrogle oblike s premerom 0,7 cm. Na eni strani imajo vtisnjeno oznako "5" in na drugi strani "1427".
(95% CI) Mean daily insulin dose (IU)1
Razlika glede na placebo (95 % IZ) Povprečni dnevni odmerek insulina (i.e.) Izhodišče (povprečje) Sprememba od izhodišča c
Increases in the amount of glucose excreted in the urine were observed in healthy subjects and in subjects with type 2 diabetes mellitus following the administration of dapagliflozin.
Pri zdravih osebah in osebah s sladkorno boleznijo tipa 2 se je po uporabi dapagliflozina povečala količina glukoze, izločene z urinom.
How to store Forxiga
Shranjevanje zdravila Forxiga
Nocturia** Renal impairment**,b
*,f nikturija okvara ledvic
Parameter
Odmerjanje
• weight decreased
• zmanjšanje telesne mase
HbA1c (%) Baseline (mean) Change from baselinec
HbA1c (%) Izhodišče (povprečje) Sprememba od izhodišča
(95% CI) Subjects with mean daily insulin dose reduction of at least 10% (%) LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Povprečje najmanjših kvadratov, prilagojeno za izhodiščno vrednost in prisotnost peroralnega antidiabetika Vrednost p < 0,0001 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika Vrednost p < 0,05 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika Povečevanje insulinske sheme (vključno s kratkodelujočim, srednjedolgodelujočim in bazalnim insulinom) je bilo dovoljeno le, če so bolniki izpolnjevali vnaprej določena merila glede glukoze v plazmi na tešče.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 5 mg
NEPERFORIRANI KOLEDARSKI PRETISNI OMOTI 5 mg
Volume depletion
Pomanjkanje volumna
EU/1/12/795/008 98 film-coated tablets
EU/1/12/795/008 98 filmsko obloženih tablet
EU/1/12/795/007 28 film-coated tablets
EU/1/12/795/007 28 filmsko obloženih tablet
EU/1/12/795/002 28 film-coated tablets
EU/1/12/795/002 28 filmsko obloženih tablet
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 10 mg
NEPERFORIRANI KOLEDARSKI PRETISNI OMOTI 10 mg
EU/1/12/795/001 14 film-coated tablets
EU/1/12/795/001 14 filmsko obloženih tablet
EU/1/12/795/003 98 film-coated tablets
EU/1/12/795/003 98 filmsko obloženih tablet
(95% CI) LOCF: Last observation (prior to rescue for rescued subjects) carried forward All randomised subjects who took at least one dose of double-blind study medication during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo § Not evaluated for statistical significance as a result of the sequential testing procedure for secondary end points
Povprečje najmanjših kvadratov, prilagojeno za izhodiščno vrednost Vrednost p < 0,0001 v primerjavi s placebom Ni ocenjeno za statistično značilnost zaradi postopka zaporednega preskušanja za sekundarne opazovane dogodke
Back pain*
• bolečine v hrbtu
NAME OF THE MEDICINAL PRODUCT Forxiga 10 mg film-coated tablets
Forxiga 10 mg filmsko obložene tablete
EU/1/12/795/006 14 film-coated tablets
EU/1/12/795/006 14 filmsko obloženih tablet
Fifty percent of subjects were on insulin monotherapy at baseline; 50% were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80% were on metformin alone, 12% were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Petdeset odstotkov preiskovancev je bilo izhodiščno na monoterapiji z insulinom; 50 % jih je poleg insulina jemalo 1 ali 2 peroralna antidiabetika.
NAME OF THE MEDICINAL PRODUCT Forxiga 5 mg film-coated tablets
Forxiga 5 mg filmsko obložene tablete
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo.
2Fifty percent of subjects were on insulin monotherapy at baseline; 50% were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80% were on metformin alone, 12% were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Med slednjimi jih je 80 % jemalo samo metformin, 12 % jih je jemalo metformin in sulfonilsečnino, preostali pa so uporabljali druge peroralne antidiabetike.
(95% CI) Body weight (kg) Baseline (mean) Change from baselinec Difference from placeboc
(95 % IZ) Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča c
Forxiga contains lactose
Vsebuje laktozo.
Your doctor may want to lower the dose of these other medicines,
Zdravnik vam bo morda zmanjšal odmerek teh drugih zdravil, da bi preprečil prekomerno zmanjšanje količine sladkorja v vaši krvi (hipoglikemijo).
Each tablet contains 50 mg of lactose anhydrous.
Pomožna snov z znanim učinkom: Ena tableta vsebuje 50 mg brezvodne laktoze.
Vulvovaginitis, balanitis and related genital infections*,b,c Urinary tract infection*,b,d
Infekcijske in parazitske bolezni vulvovaginitis, balanitis in sorodne okužbe spolovil
Renal and urinary disorders
Glukoza v urinu
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS PERFORATED UNIT DOSE 10 mg
PERFORIRANI PRETISNI OMOTI ZA POSAMEZNI ODMEREK 10 mg
Pruritus genital
Delovanje ledvic
Each tablet contains 25 mg of lactose anhydrous.
Pomožna snov z znanim učinkom: Ena tableta vsebuje 25 mg brezvodne laktoze.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS PERFORATED UNIT DOSE 5 mg
PERFORIRANI PRETISNI OMOTI ZA POSAMEZNI ODMEREK 5 mg
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 5 mg dapagliflozina.
Hepatic impairment
Okužbe sečil
Your body can also make too much sugar.
Vaše telo lahko izdela tudi preveč sladkorja.
A risk to newborns/infants cannot be excluded.
Tveganja za novorojenčke/otroke ne moremo izključiti.
• about what you can do to prevent dehydration
• kaj lahko storite, da boste preprečili dehidracijo
• Try to take it at the same time each day.
• Poskušajte jemati tableto vsak dan ob istem času.
How much to take
Koliko zdavila je potrebno vzeti
• Swallow the tablet whole with a half glass of water.
• Tableto pogoltnite celo, s pol kozarca vode.
ATC code: A10BX11.
Oznaka ATC: A10BX11.
However, if it is nearly time for the next dose, skip the missed dose.
Če pa je že skoraj čas za naslednji odmerek, izpustite pozabljeni odmerek.
It is best to take your tablet before the first meal of the day.
Najbolje je če tableto vzamete pred prvim dnevnim obrokom.
Your doctor will decide whether to increase your dose to 300 mg.
Zdravnik se bo odločil, ali bo odmerek povečal na 300 mg.
These reductions were sustained over the treatment period and near maximal after the first day of treatment.
Navedena znižanja so se ohranila v celotnem obdobju zdravljenja in so dosegala skoraj največji obseg po prvem dnevu zdravljenja.
In general, elevations were transient and did not require specific treatment.
Zvišanja so bila večinoma prehodna, specifično zdravljenje ni bilo potrebno.
In particular, tell your doctor if you are taking any of the following medicines:
Zdravnika obvestite zlasti, če jemljete katero od naslednjih zdravil:
• You can take your tablet with or without food.
• Zdravilo lahko vzamete s hrano ali brez nje.
• Your doctor will prescribe the strength that is right for you.
• Zdravnik vam bo predpisal odmerek, ki je za vas primeren.
16% of patients were Hispanic.
Šestnajst odstotkov (16%) bolnikov je bilo Špancev.
The doctor may decide to temporarily or permanently stop the treatment with Invokana.
Zdravnik vam lahko začasno ali trajno ukine zdravljenje z zdravilom Invokana.
• Do not take a double dose (two doses on the same day) to make up for a forgotten dose.
• Ne vzemite dvojnega odmerka (dveh odmerkov na isti dan), če ste pozabili vzeti prejšnji odmerek.
Active-controlled studies
Aktivno nadzorovane študije
• Risk Management Plan (RMP)
ZDRAVILA • Načrt za obvladovanje tveganja (RMP)
Lactose intolerance
Laktozna intoleranca
Do not stop taking this medicine without talking to your doctor first.
Ne prenehajte jemati tega zdravila, ne da bi se prej posvetovali s svojim zdravnikom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 November 2013
Datum prve pridobitve dovoljenja za promet: 15. 11. 2013
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).
Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
6.6 Special precautions for disposal No special requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
In both cases, treatment with canagliflozin may be restarted once the patient's condition has stabilised.
V obeh primerih se lahko zdravljenje s kanagliflozinom ponovno uvede, ko je stanje bolnikov stabilizirano.
Approximately 58% of patients were male.
Približno 58% bolnikov je bilo moškega spola.
Both UGT1A9 and UGT2B4 are subject to genetic polymorphism.
UGT1A9 in UGT2B4 sta podvržena genetskemu polimorfizmu.
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Sladkorna bolezen tipa 2 je bolezen, pri kateri vaše telo ne tvori dovolj insulina oziroma insulin, ki ga tvori vaše telo, ne deluje tako dobro, kot bi moral.
More information is given below in “Other medicines and Invokana”.
Več podatkov lahko najdete spodaj pod naslovom “Druga zdravila in zdravilo Invokanaˮ.
• severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing).
• hude alergijske reakcije (lahko vključujejo otekanje obraza, ustnic, ust, jezika, grla, zaradi česar je lahko oteženo dihanje ali požiranje).
Tablets should be swallowed whole.
Tablete je treba pogoltniti cele.
These differences are not considered to be clinically meaningful.
Navedene razlike ne veljajo za klinično pomembne.
Elderly (≥ 65 years old)
Starostniki (≥ 65 let)
This was accompanied by a sustained reduction in serum uric acid concentration of approximately 20%.
To je spremljalo vztrajno znižanje koncentracije sečne kisline v serumu za približno 20%.
Possible signs of losing too much fluid from your body are listed at the top of section 4 “Possible side effects”.
Znaki morebitnega prevelikega izločanja vode iz telesa so našteti na začetku poglavja 4 “Možni neželeni učinki”.
The safety and efficacy of canagliflozin in children under 18 years of age have not yet been established.
Varnost in učinkovitost kanagliflozina pri otrocih, mlajših od 18 let, še nista bili dokazani.
Invokana should be taken orally once a day, preferably before the first meal of the day.
Zdravilo Invokana je treba jemati peroralno enkrat na dan, najbolje pred prvim dnevnim obrokom.
Talk to your doctor about whether to stop taking this medicine or to stop breast-feeding.
Z zdravnikom se pogovorite o prenehanju jemanja tega zdravila ali o prenehanju dojenja.
Canagliflozin is extensively bound to proteins in plasma (99%), mainly to albumin.
Kanagliflozin se v veliki meri veže na beljakovine v plazmi (v 99%), večinoma na albumine.
If interrupted, consideration should be given to more frequent glucose monitoring.
V primeru prekinitve zdravljenja je treba razmisliti o bolj pogostem spremljanju glikemije.
• if you have severe liver problems
• če imate hude težave z jetri
58% of patients had a body mass index (BMI) ≥ 30 kg/m2.
58% bolnikov je imelo indeks telesne mase (ITM) ≥ 30 kg/m2.
• loss of too much fluid from your body (dehydration).
• prevelika izguba telesnih tekočin (dehidracija).
SGLT2 inhibitors should be used with caution in these patients.
Pri teh bolnikih je treba uporabljati zaviralce SGLT2 previdno.
Other medicines and Invokana
Druga zdravila in zdravilo Invokana
** See section 4.4.
** glejte poglavje 4.4.
Invokana should not be used for the treatment of diabetic ketoacidosis as it is not effective in this setting.
Zdravila Invokana ne smete uporabljati za zdravljenje diabetične ketoacidoze, saj pri tem ni učinkovito.
• The starting dose of Invokana is one 100 mg tablet each day.
• Začetni odmerek zdravila Invokana je ena 100 mg tableta na dan.
Your doctor will tell you how to treat low blood sugar levels and what to do if you have any of the signs above.
Zdravnik vam bo povedal, kako ravnati v primeru znižane koncentracije sladkorja v krvi in kaj morate storiti, če se pojavijo našteti znaki.
The mean absolute oral bioavailability of canagliflozin is approximately 65%.
Povprečna absolutna peroralna biološka uporabnost kanagliflozina je približno 65%.
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
Children and adolescents Invokana is not recommended for children and adolescents under 18 years.
Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Invokana ni priporočena.
Patients taking digoxin or other cardiac glycosides (e.g., digitoxin) should be monitored appropriately.
Bolnike, ki jemljejo digoksin ali druge kardiotonične glikozide (na primer digitoksin), je treba ustrezno spremljati.
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.
Če bolnik izpusti odmerek, naj ga vzame takoj, ko se spomni, vendar na isti dan ne sme vzeti dveh odmerkov zdravila.
• changes in urination (including urinating more frequently or in larger amounts, urgent need to urinate, need to urinate at night)
• spremembe pri uriniranju (vključno s pogostejšim odvajanjem urina ali z odvajanjem večjih količin urina, z občutkom nuje po uriniranju in s potrebo po uriniranju ponoči)
Urine laboratory assessments
Laboratorijske preiskave urina
• feeling thirsty
• občutek žeje
Diabetic ketoacidosis**
redki diabetična ketoacidoza**
• if you are on medicines to lower your blood pressure (anti-hypertensives) or have ever had low blood pressure (hypotension).
• če jemljete zdravila za zniževanje krvnega tlaka (antihipertenzive) in ste že kdaj imeli znižan krvni tlak (hipotenzijo).
The effect of being homozygote (UGT1A9*3/*3, frequency < 0.1%) is probably more marked, but has not been investigated.
(UGT1A9*3/*3, pogostnost < 0,1%), vendar tega niso preiskovali.
The hazard ratios for the 100 mg and 300 mg doses were similar.
Razmerji ogroženosti za odmerek 100 mg in 300 mg sta bili podobni.
The pharmacokinetics of canagliflozin are essentially similar in healthy subjects and patients with type 2 diabetes.
Farmakokinetika kanagliflozina je v bistvu enaka pri zdravih osebah in pri bolnikih s sladkorno boleznijo tipa 2.
Monotherapy (26 weeks)
Monoterapija (26 tednov)
• if you have ever had serious heart disease or if you have had a stroke
• če ste že imeli katero od resnih bolezni srca ali ste preživeli možgansko kap
This is because this medicine can affect the way some other medicines work.
To zdravilo lahko namreč vpliva na delovanje nekaterih drugih zdravil, pa tudi nekatera druga zdravila lahko vplivajo na delovanje tega zdravila.
When this happens, sugar (glucose) builds up in the blood.
Če pride do tega, se raven sladkorja (glukoze) v krvi zviša.
Each tablet contains 117.78 mg lactose.
Ena tableta vsebuje 117,78 mg laktoze.
Invokana has not been studied in patients with type 1 diabetes and is therefore not recommended for use in these patients.
Zdravila Invokana niso proučevali pri bolnikih s sladkorno boleznijo tipa 1, zato uporaba pri teh bolnikih ni priporočena.
There was no notable change in heart rate.
Pri tem ni prišlo do opazne spremembe srčne frekvence.
Each tablet contains 39.2 mg lactose.
Ena tableta vsebuje 39,2 mg laktoze.
Two hundred eleven (211) patients from the clinical study in older patients participated in a body composition substudy using DXA body composition analysis.
Dvestoenajst (211) bolnikov iz klinične študije s starejšimi bolniki je sodelovalo v podskupini, v kateri so bolnikom analizirali sestavo telesa z metodo DEXA.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking or continuing to take this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete to zdravilo ali preden nadaljujete z jemanjem tega zdravila.