natgillin/translations-raw huggingface dataset:
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.
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
The 100 mg tablet also contains iron oxide yellow (E172). 
100 mg tablete vsebujejo tudi rumeni železov oksid (E172).
The racial distribution was 72% White, 16% Asian, 4% Black, and 8% other groups. 
Pripadnost različnim rasam je bila naslednja: 72% bolnikov je bilo bele rase, 16% azijske rase, 4% črne rase, 8% je bilo pripadnikov drugih etničnih skupin.
Older patients 
Starejši bolniki
Invokana should not be used during pregnancy. 
Zdravila Invokana se ne sme jemati med nosečnostjo.
No clinically relevant effect on CYP3A4 was observed in vivo (see section 4.5). 
In vivo niso opazili klinično pomembnega učinka na CYP3A4 (glejte poglavje 4.5).
A study in juvenile rats administered canagliflozin from day 1 through day 90 postnatal did not show increased sensitivity compared to effects observed in adults rats. 
Študija pri podganjih mladičih, ki so jim dajali kanagliflozin od 1. do 90. dne po skotitvi, ni pokazala povečane občutljivosti v primerjavi z učinki, ki so jih opazili pri odraslih podganah.
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. 
V primeru prevelikega odmerjanja je smiselno začeti z običajnimi podpornimi ukrepi, kot so odstranjevanje nabsorbiranega zdravila iz prebavil, klinično spremljanje bolnika in uvedba kliničnih ukrepov, če so potrebni.
There are no data from the use of canagliflozin in pregnant women. 
Ni podatkov o uporabi kanagliflozina pri nosečnicah.
The European Medicines Agency has deferred the obligation to submit the results of studies with canagliflozin in one or more subsets of the paediatric population in type 2 diabetes (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s kanagliflozinom za eno ali več podskupin pediatrične populacije pri sladkorni bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
It is unknown whether canagliflozin and/or its metabolites are excreted in human milk. 
Ni znano ali se kanagliflozin in/ali njegovi presnovki izločajo v materino mleko.
Most reports of vulvovaginal candidiasis occurred during the first four months of treatment with canagliflozin. 
Do večine poročil o vulvovaginalni kandidozi je prišlo v prvih štiri mesecih zdravljenja s kanagliflozinom.
It is not known if DKA is more likely to occur with higher doses of canagliflozin. 
Ni znano, ali je DKA verjetnejša pri večjih odmerkih kanagliflozina.
• digoxin or digitoxin (medicines used for certain heart problems). 
• digoksin ali digitoksin (zdravili, ki ju uporabljamo pri določenih boleznih srca).
* Related to volume depletion; see section 4.4. 
* v povezavi s hipovolemijo; glejte poglavje 4.4.
10 x 1 film-coated tablets 30 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets 
10 x 1 filmsko obložena tableta 30 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta 100 x 1 filmsko obložena tableta
This may occur regardless of blood glucose level. 
To se lahko pojavi ne glede na koncetracije glukoze v krvi.
These increases in canagliflozin exposure are not expected to be clinically relevant. 
Ni pričakovano, da bi bila ta povečanja izpostavljenosti kanagliflozinu klinično pomembna.
Less than 1% of the dose was excreted as unchanged canagliflozin in urine. 
V urinu se je izločil manj kot 1% odmerka nespremenjenega kanagliflozina.
The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness. 
Tveganje za razvoj diabetične ketoacidoze je lahko povečano v primeru dolgotrajnega stradanja, prekomernega uživanja alkohola, dehidracije, nenadnega zmanjšanja odmerka insulina ali povečane potrebe po insulinu zaradi večjega kirurškega posega ali resne bolezni.
• If your doctor has prescribed canagliflozin along with any bile acid sequestrant such as cholestyramine (medicines for lowering cholesterol) you should take canagliflozin at least 1 hour before or 4 hours to 6 hours after the bile acid sequestrant. 
• Če vam je zdravnik predpisal kanagliflozin skupaj z adsorbentom žolčnih kislin, kot je holestiramin (zdravilo za zniževanje holesterola v krvi), morate vzeti kanagliflozin vsaj 1 uro prej ali 4 do 6 ur po tem, ko ste vzeli adsorbent žolčnih kislin.
The majority of genital mycotic infections were treated with topical antifungal treatments, either prescribed by a healthcare professional or self-treated while continuing therapy with Invokana. 
Genitalne glivične okužbe so večinoma zdravili z lokalnimi antimikotiki, ki jih je bodisi predpisal zdravnik ali pa so se bolniki z njimi zdravili sami, zdravljenje z zdravilom Invokana pa so pri tem nadaljevali.
• rifampicin (an antibiotic used to treat tuberculosis) 
• rifampicin (antibiotik, ki ga uporabljamo pri zdravljenju tuberkuloze)
In rare instances, phimosis was reported and sometimes circumcision was performed. 
V redkih primerih so poročali o fimozi in v nekaj primerih so izvedli cirkumcizijo.
Patients had an overall mean age of 59.6 years (range 21 years to 96 years), with 3,082 patients ≥ 65 years of age and 510 patients ≥ 75 years of age. 
Povprečna starost vseh bolnikov je bila 59,6 let (od 21 do 96 let), pri čemer je bilo 3.082 bolnikov starih najmanj 65 let, 510 bolnikov pa najmanj 75 let.
Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. 
Pri bolnikih, ki so hospitalizirani zaradi večjih kirurških posegov ali resnih akutnih bolezni, je treba zdravljenje prekiniti.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product. 
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
• kidney failure (mainly as a consequence of loss of too much fluid from your body). 
• ledvična odpoved (kot posledica prevelike izgube tekočine iz telesa)