natgillin/translations-raw huggingface dataset:
Haematocrit increase was observed with dapagliflozin treatment, (see section 4.8); therefore, caution in patients with already elevated haematocrit is warranted. 
Med zdravljenjem z dapagliflozinom so opažali zvišanje hematokrita (glejte poglavje 4.8).
The majority of the genital infection adverse events were reported in females (84 % of subjects with a genital infection), were mild or moderate in intensity, of single occurrence, and most patients continued on therapy. 
O večini okužb spolovil so poročali pri ženskah (84 % preiskovancev z okužbo spolovil).
C, urticaria 
C, urtikarija angioedem
Experience in NYHA class I-II is limited in dapagliflozin. 
• Učinkovini sta saksagliptin in dapagliflozin.
Talk to your doctor if you would like to or are breast-feeding before taking this medicine. 
Če dojite ali želite dojiti, se pred jemanjem tega zdravila posvetujte z zdravnikom.
A total of 534 adult patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin alone (HbA1c ≥ 8 % and ≤ 12 %), participated in this 24-week randomised, double-blind, active comparator-controlled superiority trial to compare the combination of saxagliptin and dapagliflozin added concurrently to metformin, versus saxagliptin (DPP-4 inhibitor) or dapagliflozin (SGLT2 inhibitor) added to metformin. 
To 24-tedensko randomizirano, dvojno slepo, z aktivno učinkovino kontrolirano preskušanje je zajelo skupaj 534 odraslih bolnikov s sladkorno boleznijo tipa 2, ki glikemije niso imeli ustrezno urejene s samim metforminom (HbA1c ≥ 8 % in ≤ 12 %).
F, blood urea increased, weight decreased 
zvišanje hematokrita zvišanje kreatinina v krvi zvišanje sečnine v krvi, zmanjšanje telesne mase
Other side effects when taking Qtern alone or in combination with metformin: Common - genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour) - back pain - passing more water (urine) than usual or needing to pass water more often - changes in the amount of cholesterol or fats in your blood (shown in tests) - increases in the amount of red blood cells in your blood (shown in tests) - decreases in creatinine renal clearance (shown in tests) 
Drugi neželeni učinki med jemanjem zdravila Qtern samega ali v kombinaciji z metforminom: Pogosti - okužba spolovil (glivice) na spolnem udu ali v nožnici (med znaki so lahko draženje, srbenje,
Description of selected adverse reactions Hypoglycaemia 
Uporaba z zdravili, ki povzročajo hipoglikemijo
Dermatitis 
dislipidemija
Titanium dioxide (E171) Talc (E553b) 
Filmska obloga polivinilalkohol (E1203) makrogol 3350 titanov dioksid (E171) smukec (E553b) rumeni železov oksid (E172) rdeči železov oksid (E172)
Volume depletion F, 
4 zmanjšanje volumna
This overview was last updated in November 2018. 
Pregled je bil nazadnje posodobljen novembra 2018.
This will help to protect them against the disease. 
Ta mu bodo pomagala pri obrambi pred boleznijo.
Further information on Syvazul BTV can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/syvazul-btv. 
Nadaljnje informacije o cepivu Syvazul BTV so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/syvazul-btv.
The European Medicines Agency decided that Syvazul BTV's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi cepiva Syvazul BTV večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The second injection is given 3 weeks after the first. 
Drugi odmerek se injicira tri tedne po injiciranju prvega.
The main measure of effectiveness was the presence of virus in the blood and the studies have shown that the vaccine is effective in producing protective antibodies in sheep and cattle. 
Glavno merilo učinkovitosti je bila prisotnost virusa v krvi, študije pa so pokazale, da je cepivo učinkovito pri tvorjenju zaščitnih protiteles pri ovcah in govedu.
People who are hypersensitive (allergic) to aluminium hydroxide, thiomersal or saponins should avoid contact with Syvazul BTV. 
Ljudje, ki so preobčutljivi za (alergični na) aluminijev hidroksid, tiomersal ali saponine, se morajo izogibati stiku s cepivom Syvazul BTV.
Syvazul BTV received a marketing authorisation valid throughout the EU on 9 January 2019. 
Cepivo Syvazul BTV je pridobilo dovoljenje za promet, veljavno po vsej EU, 09/01/2019.
The vaccine contains inactivated (killed) bluetongue viruses. 
Cepivo vsebuje inaktivirane (uničene) viruse modrikastega jezika.
The most common side effects with Syvazul BTV (which may affect more than 1 in 10 animals) are local injection site reactions, erythema (reddening of the skin) with mild to moderate swelling 1 to 6 days after vaccination, a painless nodule (up to 3.8 cm diameter in sheep and 7 cm diameter in cattle) 2 to 6 days after vaccination and a short-lived increase in body temperature of no more than 2.3˚C in the 48 hours after vaccination. 
Najpogostejši neželeni učinki zdravila Syvazul BTV (ki lahko prizadenejo več kot 1 žival od 10) so lokalne reakcije na mestu injiciranja, eritem (pordelost kože) z blago do zmerno oteklino, ki traja od enega do šest dni po cepljenju, neboleč vozlič (s premerom do 3,8 cm pri ovcah in 7 cm pri govedu), ki se pojavi od dva do šest dni po cepljenju in kratkotrajno povišanje telesne temperature za največ 2,3˚C v 48 urah po cepljenju.
The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) that enhance the response of the immune system. 
Vsebuje tudi „adjuvansa“ (aluminijev hidroksid in saponin) za povečanje imunskega odziva.
The vaccine is available as an injection and can only be obtained with a prescription. 
Cepivo je na voljo v obliki injekcije, njegovo predpisovanje in izdaja pa je le na recept.
In the future, if the animals are exposed to the bluetongue virus, their immune system will be able to produce antibodies more quickly. 
Ob ponovni izpostavitvi virusu modrikastega jezika v prihodnosti bo imunski sistem lahko hitreje tvoril protitelesa.
Other information about Syvazul BTV 
Druge informacije o zdravilu Syvazul BTV
Syvazul BTV is a vaccine. 
Zdravilo Syvazul BTV je cepivo.
The withdrawal period for meat and milk from sheep and cattle treated with Syvazul BRV is ‘zero' days, which means that there is no mandatory waiting time. 
Karenca za meso in mleko ovac in goveda, cepljenih s cepivom Syvazul BTV, je „nič“ dni, kar pomeni, da ni obvezne čakalne dobe.
The variety (serotype) of the virus in the vaccine is selected depending on which serotypes are circulating and causing disease at the time of manufacture, so it may contain serotype 1, 4 or 8 or a combination of any two of these. 
Vrsta (serotip) virusa v cepivu je izbrana glede na to, kateri serotipi krožijo in povzročajo obolenje v času proizvodnje cepiva, zato lahko vsebuje serotip 1, 4 ali 8 oziroma kombinacijo dveh serotipov.
For more information about using Syvazul BTV, see the package leaflet or contact your veterinarian or pharmacist. 
Za več informacij glede uporabe zdravila Syvazul BTV glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
For the full list of side effects and restrictions of Syvazul BTV, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi cepiva Syvazul BTV glejte navodilo za uporabo.
An overview of Syvazul BTV and why it is authorised in the EU 
Pregled zdravila Syvazul BTV in zakaj je odobreno v EU
The vaccine is given as two injections into a muscle to calves from 2 months of age if the calves have no immunity to bluetongue virus or from 3 months of age in calves born to mothers already immune to the disease. 
Cepivo se v dveh odmerkih injicira v mišico teličkom v starosti od dveh mesecev dalje, če niso imuni proti virusu modrikastega jezika, ali v starosti od treh mesecev dalje, če so se skotili kravam, ki so proti tej bolezni že imune.
When it is given to sheep and cattle, the animals' immune systems recognise the viruses as ‘foreign' and make antibodies against them. 
Ko ovce in govedo prejmejo cepivo, njihov imunski sistem prepozna viruse kot tujke in proti njim razvije protitelesa.
Syvazul BTV contains bluetongue viruses that have been inactivated so that they cannot cause the disease. 
Cepivo Syvazul BTV vsebuje viruse modrikastega jezika, ki so inaktivirani in ne morejo povzročiti bolezni.
Why is Syvazul BTV authorised in the EU? 
Zakaj je zdravilo Syvazul BTV odobreno v EU?
Syvazul BTV is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. 
Zdravilo Syvazul BTV je cepivo, ki se uporablja pri ovcah in govedu za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo prenašajo trzače, povzroča pa jo virus modrikastega jezika.
Safety information has been included in the summary of product characteristics and the package leaflet for Syvazul BTV, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers. 
V povzetek glavnih značilnosti cepiva Syvazul BTV in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
Laboratory studies were conducted in which sheep and cattle vaccinated with Syvazul BTV were exposed to BTV serotype 1, 4 or 8. 
Izvedene so bile laboratorijske študije, v katerih so bili ovce in govedo, cepljeni s cepivom Syvazul BTV, izpostavljeni serotipom 1, 4 ali 8 virusa bolezni modrikastega jezika.
No field studies were provided with BTV-4 in sheep or cattle, however, the laboratory studies were considered sufficient to show effectiveness of the BTV-4 vaccine. 
Pri ovcah in govedu ni bilo opravljenih terenskih študij s serotipom 4 virusa modrikastega jezika, vendar so bile laboratorijske študije ocenjene kot zadostne za prikaz učinkovitosti cepiva za serotip 4.
What benefits of Syvazul BTV have been shown in studies? 
Kakšne koristi je zdravilo Syvazul BTV izkazalo v študijah?
What is Syvazul BTV and what is it used for? 
Kaj je zdravilo Syvazul BTV in za kaj se uporablja?
What are the risks associated with Syvazul BTV? 
Kakšna tveganja so povezana z zdravilom Syvazul BTV?
Revaccination is required after 1 year. 
Po enem letu je treba cepljenje ponoviti.
Effectiveness was measured by comparing antibody levels to the virus at days 35 and 63 after vaccination with levels from laboratory studies. 
Učinkovitost so merili s primerjavo ravni protiteles proti virusu na 35. in 63. dan po cepljenju z ravnmi iz laboratorijskih študij.
Effectiveness was measured by comparing antibody levels at 21 and 42 days after completing the initial vaccination course with levels from laboratory studies. 
Učinkovitost so merili s primerjavo ravni protiteles na 21. in 42. dan po zaključku začetnega sklopa cepljenj z ravnmi iz laboratorijskih študij.
Syvazul BTV contains bluetongue virus of one or two types selected from serotypes 1, 4 and 8. 
Cepivo Syvazul BTV vsebuje eno ali dve vrsti izbranih serotipov virusa bolezni modrikastega jezika, in sicer 1, 4 in 8.
The data showed that antibody levels at day 42 after vaccination for each group remained at levels similar to day 21 after vaccination and above levels from the laboratory studies. 
Podatki so pokazali, da so ravni protiteles na 42. dan po cepljenju za vse skupine ostale podobne ravnem, doseženim na 21. dan po cepljenju, in nad ravnmi iz laboratorijskih študij.
The data showed that antibody levels at day 63 after vaccination for each group remained at levels similar to day 35 after vaccination and above levels from the laboratory studies. 
Podatki so pokazali, da so ravni protiteles na 63. dan po cepljenju za vse skupine ostale podobne ravnem, doseženim na 35. dan po cepljenju, in nad ravnmi iz laboratorijskih študij.
Laboratory studies showed that in sheep the vaccine starts to be effective 39 days after vaccination and protection lasts for 1 year. 
Laboratorijske študije so pokazale, da cepivo pri ovcah začne učinkovati 39 dni po cepljenju, zaščita pa traja eno leto.
Revaccination with one injection is required after 1 year. 
Po enem letu je treba cepljenje ponoviti z enim odmerkom.
How is Syvazul BTV used? 
Kako se zdravilo Syvazul BTV uporablja?
The vaccine starts to be effective 21 days after completion of the initial vaccination course and protection lasts one year. 
Cepivo začne učinkovati 21 dni po zaključku začetnega sklopa cepljenja, zaščita pa traja eno leto.
In a field study, 3 groups of 35 lambs from 3 months of age (with no antibodies to bluetongue virus) received vaccination with vaccines containing BTV-1, BTV-8 and BTV 1+8. 
V terenski študiji so tri skupine po 35 jagnjet v starosti od treh mesecev dalje (brez protiteles proti virusu modrikastega jezika) bile cepljene s cepivi, ki so vsebovala serotip 1 ali 8 oziroma kombinacijo serotipov 1 in 8 virusa modrikastega jezika.
Laboratory studies showed that in cattle the vaccine starts to be effective 21 days after completion of the initial vaccination course and protection lasts one year. 
Laboratorijske študije so pokazale, da cepivo pri govedu začne učinkovati 21 dni po zaključku začetnega sklopa cepljenja, zaščita pa traja eno leto.
How does Syvazul BTV work? 
Kako zdravilo Syvazul BTV deluje?
The vaccine is given as a single injection under the skin to sheep from 3 months of age. 
Cepivo se ovcam od starosti treh mesecev injicira v podkožje v enem odmerku.
The vaccine starts to be effective 39 days after vaccination and protection lasts for 1 year. 
Cepivo začne učinkovati 39 dni po cepljenju, zaščita pa traja eno leto.
Groups of 25 calves from 2 months of age (with no antibodies to bluetongue virus) were vaccinated with vaccines containing BTV-1, BTV-8 and BTV 1+8 in a field study. 
V terenski študiji so bile skupine po 25 teličkov v starosti od dveh mesecev dalje (brez protiteles proti bolezni modrikastega jezika) cepljenje s cepivi, ki so vsebovala serotip 1 ali 8 oziroma kombinacijo serotipov 1 in 8 virusa modrikastega jezika.
Do not take it if you are not going to eat a main meal. 
Ne vzemite ga, če ne nameravate pojesti glavnega obroka.
The clinical experience in patients over 75 years of age is limited. 
Klinične izkušnje pri bolnikih, starejših od 75 let, so omejene.
Your treatment may need to be adjusted. 
Mogoče bo treba prilagoditi vaše zdravljenje.
Post-marketing data revealed very rare cases of erythema multiforme. 
Postmarketinški podatki so razkrili zelo redke primere multiformnega eritema.
Approximately 
Približno
Your doctor may adjust the dose of these medicines. 
Zdravnik vam lahko prilagodi odmerek teh zdravil.
Absolute oral bioavailability is estimated to be 72%. 
Ocenjujejo, da je absolutna peroralna biološka uporabnost 72 %.
Swallow the tablets whole with a glass of water before the meal. 
Tablete pogoltnite cele s kozarcem vode pred obrokom.
Talk to your doctor if you have any further questions or you think that any of these may apply to you. 
Pogovorite se z zdravnikom, če imate še kakšna vprašanja ali če mislite, da utegne kaj od zgoraj navedenega veljati za vas.
• Pregnancy and breast-feeding (see section 4.6) 
• z nosečnostjo in dojenjem (glejte poglavje 4.6);
Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner). 
Nateglinid je treba jemati 1 do 30 minut pred obroki (navadno pred zajtrkom, kosilom in večerjo).
Studies in animals have shown developmental toxicity (see section 5.3). 
Študije na živalih so pokazale vpliv na razvoj (glejte poglavje 5.3).
Frequencies are defined as: common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000). 
Pogostnost je definirana takole: pogosti (>1/100, <1/10); občasni (>1/1.000, <1/100); redki (>1/10.000, <1/1.000); zelo redki (<1/10.000).
In some cases your doctor may prescribe higher doses. 
V nekaterih primerih vam bo zdravnik predpisal višje odmerke.
6-16% of the administered dose was excreted in the urine as unchanged drug. 
6-16 % danega odmerka se je izločilo v urinu v obliki nespremenjenega zdravila.
These were generally mild in nature and easily handled by intake of carbohydrates when necessary. 
V splošnem so bili blage narave in zlahka obvladljivi z zaužitjem ogljikovih hidratov, kadar je bilo potrebno.
It is used by people with type 2 diabetes. 
Uporabljajo ga ljudje s sladkorno boleznijo tipa 2.
If any of these apply to you, monitor your blood sugar levels more carefully. 
Če kaj od zgoraj navedenega velja za vas, skrbneje spremljajte svojo raven krvnega sladkorja.
There is no experience in pregnant women, therefore the safety of Trazec in pregnant women cannot be assessed. 
Ni izkušenj o uporabi pri nosečnicah, zato varnost uporabe Trazeca pri nosečnicah ne more biti ocenjena.
Trazec is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied. 
Trazec ni priporočljiv za otroke in mladostnike (mlajše od 18 let), ker njegovih učinkov v tej starostni skupini niso proučevali.
If you forget to take a tablet simply take the next one before your next meal. 
Če pozabite vzeti tableto, preprosto vzemite naslednjo tableto pred naslednjim obrokom.
• Diabetic ketoacidosis, with or without coma 
• z diabetično ketoacidozo, s komo ali brez nje;
At such times, it may be necessary to discontinue oral hypoglycaemic treatment and replace it with insulin on a temporary basis. 
Takrat utegne biti potrebno prekiniti peroralno hipoglikemično zdravljenje in ga začasno nadomestiti z insulinom.
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 03.04.2001 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 03.04.2001
Treatment is therefore not recommended in these patient groups. 
Pri teh skupinah bolnikov zdravljenje zato ni priporočljivo.
If you feel as if you are about to have a severe hypoglycaemic attack (which may lead to loss of consciousness or seizure), call for urgent medical help - or make sure that someone else does this for you. 
Če imate občutek, da boste dobili hud napad hipoglikemije (ki lahko povzroči izgubo zavesti ali napad krčev), pokličite nujno medicinsko pomoč - ali poskrbite, da to namesto vas stori kdo drug.
Alcohol may upset the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking Trazec. 
Alkohol lahko poslabša kontrolo vašega krvnega sladkorja, zato je priporočljivo, da se glede uživanja alkohola v času jemanja Trazeca pogovorite z zdravnikom.
Insulin is a substance produced by a body organ called the pancreas. 
Insulin je snov, ki ga izdeluje telesni organ, ki se imenuje trebušna slinavka.
This depolarises the beta cell and leads to an opening of the calcium channels. 
To depolarizira celico beta in povzroči odpiranje kalcijevih kanalčkov.
It helps to decrease blood sugar levels, especially after meals. 
Pomaga zniževati koncentracijo krvnega sladkorja, zlasti po obrokih hrane.
If you have any further questions, ask your doctor or pharmacist. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
Even though you are taking medicines for your diabetes, it is important to keep following the diet and/or exercise your doctor has recommended for you. 
Čeprav kot sladkorni bolnik jemljete zdravila, je pomembno, da se še naprej držite diete in/ali programa telesne aktivnosti, ki vam ju je priporočil zdravnik.
Take special care to avoid low blood sugar. 
Zlasti poskrbite, da se izognete nizkemu krvnemu sladkorju.
Your doctor will prescribe Trazec together with another oral anti-diabetic containing metformin. 
Zdravnik vam bo predpisal Trazec skupaj z drugim peroralnim antidiabetikom, ki vsebuje metformin.
Some people are more likely to get symptoms of low blood sugar than others. 
Pri nekaterih ljudeh se bodo verjetneje pojavili simptomi nizkega krvnega sladkorja kot pri drugih.
It is best to take it right before a main meal but you can take it up to 30 minutes before. 
Najbolje je, če ga vzamete tik pred glavnim obrokom, lahko pa ga vzamete tudi do 30 minut pred obrokom.
They can also be caused by lack of food or too high a dose of any anti-diabetic medicine you are taking. 
Neželene učinke lahko povzroči tudi pomanjkanje hrane ali prevelik odmerek kakega zdravila za sladkorno bolezen, ki ga jemljete.
(This kind of diabetes is also called non-insulin-dependent 
(Ta vrsta sladkorne bolezni se imenuje tudi insulinsko neodvisni diabetes mellitus.)
The amount of Trazec that you need may change if you take other medicines as these may cause your blood sugar levels to go up or down. 
Vaše potrebe po Trazecu se lahko spremenijo, če jemljete druga zdravila, ker to lahko povzroči zvišanje ali znižanje vaših vrednosti krvnega sladkorja.
Take Trazec before meals (see section 3, “How to take Trazec”). 
Jemljite Trazec pred obroki (glejte poglavje 3, “Kako jemati zdravilo Trazec”).
Although it is not known whether nateglinide is excreted in human milk, the potential for hypoglycaemia in breast-fed infants may exist and therefore nateglinide should not be used in lactating women. 
Čeprav ni znano, ali se nateglinid izloča v materino mleko pri ljudeh, lahko pri dojenih dojenčkih obstaja potencial za hipoglikemijo, zato se nateglinid pri doječih materah ne sme uporabljati.
Most of the [14C] nateglinide is excreted in the urine (83%), with an additional 10% eliminated in the faeces. 
Večina nateglinida, označenega s [14C], se izloči v urinu (83 %), dodatnih 10 % pa se ga odstrani iz telesa z blatom.
It is recommended that Trazec be administered prior to meals. 
Priporočljivo je jemanje Trazeca pred obroki.
This may be increased to 120 mg three times daily. 
Odmerek se sme povečati na 120 mg trikrat na dan.
Approximately 75% of the administered [14C] nateglinide is recovered in the urine within six hours post-dose. 
Približno 75 % danega [14C] nateglinida v šestih urah po odmerku prestrežemo v urinu.
Trazec and children and adolescents 
Trazec ter otroci in mladostniki
Nateglinide was not teratogenic in rats. 
Pri podganah nateglinid ni bil teratogen.
If you forget to take Trazec 
Če ste pozabili vzeti zdravilo Trazec
There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its use in this age group is not recommended. 
O uporabi nateglinida pri bolnikih, mlajših od 18 let, ni podatkov, zato njegova uporaba v tej starostni skupini ni priporočljiva.
Nateglinide should not be used in monotherapy. 
Splošno Nateglinid se ne sme uporabljati v monoterapiji.
Important information about some of the ingredients of Trazec Trazec tablets contain lactose monohydrate. 
Pomembne informacije o nekaterih sestavinah zdravila Trazec Tablete Trazec vsebujejo laktozo monohidrat.
As patients with severe liver disease were not studied, nateglinide is contraindicated in this group. 
Ker bolniki s hudo boleznijo jeter niso proučeni, je nateglinid v tej skupini kontraindiciran.
Electrophysiological studies demonstrate that nateglinide has 45-300-fold selectivity for pancreatic beta cell versus cardiovascular K+ATP channels. 
Elektrofiziološke študije kažejo, da ima nateglinid 45-300-kratno selektivnost za pankreatično celico beta v primerjavi s kardiovaskularnimi kanalčki K+ATP.
However, there is a delay in the rate of absorption characterised by a decrease in Cmax and a delay in time to peak plasma concentration (tmax). 
Vendar se absorpcija upočasni, za kar je značilno zmanjšanje Cmax in podaljšan čas do najvišje koncentracije v plazmi (tmax).
Hypoglycaemia has been observed in patients with type 2 diabetes on diet and exercise, and in those treated with oral antidiabetic agents (see section 4.8). 
Hipoglikemija je bila opazovana pri bolnikih s sladkorno boleznijo tipa 2 na dieti in pri telesnem naporu ter pri tistih, ki se zdravijo s peroralnimi antidiabetiki (glejte poglavje 4.8).
Interaction studies with a 3A4 inhibitor have not been carried out in vivo. 
Študije medsebojnega delovanja z zaviralcem 3A4 in vivo niso opravljene.