natgillin/translations-raw huggingface dataset:
LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg /0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection LOVENOX (and associated names) 12,000 IU (120 mg)/0.8 mL solution for injection LOVENOX (and associated names) 15,000 IU (150 mg)/1 mL solution for injection 
LOVENOX (in povezana imena) 2.000 i.e. (20 mg)/0,2 ml raztopina za injiciranje LOVENOX (in povezana imena) 4.000 i.e. (40 mg)/0,4 ml raztopina za injiciranje LOVENOX (in povezana imena) 6.000 i.e. (60 mg)/0,6 ml raztopina za injiciranje LOVENOX (in povezana imena) 8.000 i.e. (80 mg)/0,8 ml raztopina za injiciranje LOVENOX (in povezana imena) 10.000 i.e. (100 mg)/1 ml raztopina za injiciranje LOVENOX (in povezana imena) 12.000 i.e. (120 mg)/0,8 ml raztopina za injiciranje LOVENOX (in povezana imena) 15.000 i.e. (150 mg)/1 ml raztopina za injiciranje enoksaparin
All Treated DVT Patients with or without PE Total VTE (%) 
Vse VTE (%) Samo GVT (%) Proksimalne GVT PE (%)
6.6 Special precautions for disposal and other handling [To be completed nationally] 
4.4 Posebna opozorila in previdnostni ukrepi • Splošno
PACKAGE LEAFLET 
Odmerna shema
NAME OF THE MEDICINAL PRODUCT LOVENOX 10 x 4,000 IU (10 x 40 mg) Pen Enoxaparin STATEMENT OF ACTIVE SUBSTANCE(S) 1 pen contains 3.0 mL corresponding to 10 single doses of 4,000 IU (40 mg) enoxaparin sodium. 
1 peresnik vsebuje 3,0 ml, kar ustreza 10 enkratnim odmerkom 4.000 i.e. (40 mg) natrijevega enoksaparinata.
Thrombocytopenia and thrombocytosis System 
Trombocitopenija in trombocitoza
100 IU/kg (1 mg/kg) body weight SC once daily 
i.e./kg (1,5 mg/kg) enkrat na dan 0,19 i.e./ml.
Volume to be injected through IV line after dilution is completed at a concentration of 300 IU (3 mg) /mL. 
Količina, ki jo je treba injicirati v intravensko linijo po dokončanem razredčenju na koncentracijo
Enoxaparin sodium, as with any other anticoagulant therapy, should be used with caution in conditions with increased potential for bleeding, such as: - impaired haemostasis, - history of peptic ulcer, - recent ischemic stroke, - severe arterial hypertension, recent diabetic retinopathy, - neuro- or ophthalmologic surgery, - concomitant use of medications affecting haemostasis (see section 4.5). 
Med takšna zdravila spadajo na primer: - sistemski salicilati, acetilsalicilna kislina v protivnetnih odmerkih in NSAID, vključno s ketorolakom, - drugi trombolitiki (npr. alteplaza, reteplaza, streptokinaza, tenekteplaza, urokinaza) in antikoagulansi (glejte poglavje 4.2).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTIPLE DOSE VIALS 
V dvojno slepi, multicentrični študiji vzporednih skupin so natrijev enoksaparinat v odmerkih
Immune system disorders 
Imuno-alergijska trombocitopenija
Rare (may affect up to 1 in 1,000 people) 
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) • Huda alergijska reakcija.
• Sudden severe headache. 
• Pogosti: Glavobol* Žilne bolezni
- The active substance(s) is enoxaparin sodium 
- Zdravilna učinkovina je natrijev enoksaparinat.
some medicines for heart problems. 
priloženem v pakiranju zdravila.
After repeated SC administration of the 100 IU/kg (1 mg/kg) twice daily regimen, the steady-state is reached from day 3 to 4 with mean exposure about 65% higher than after a single dose and mean maximum and trough anti-Xa activity levels of about 1.2 and 0.52 IU/mL, respectively. 
Povprečna izpostavljenost je približno 65 % večja kot po enkratnem odmerku, povprečna največja raven aktivnosti anti-Xa je približno 1,2 i.e./ml in povprečna najmanjša raven okoli 0,52
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally] 
[Glejte Prilogo I - Izpolni država članica] KAKOVOSTNA IN KOLIČINSKA SESTAVA
Major bleeding were respectively 1.7% in the enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day group, 1.3% in the enoxaparin sodium 100 IU/kg (1mg/kg) twice a day group and 2.1% in the heparin group. 
Večjih krvavitev je bilo v skupini s 150 i.e./kg (1,5 mg/kg) natrijevega enoksaparinata enkrat na dan
Most cases were mild and none were severe. 
Večinoma so bili blagi, nobeden pa ni bil resen.
The European Commission granted a marketing authorisation valid throughout the European Union for Trajenta on 24 August 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Trajenta, veljavno po vsej Evropski uniji, odobrila dne 24. avgusta 2011.
Other information about Trajenta 
Druge informacije o zdravilu Trajenta
The recommended dose of Trajenta is one tablet once a day. 
Priporočeni odmerek zdravila Trajenta je ena tableta enkrat dnevno.
EPAR summary for the public linagliptin 
Povzetek EPAR za javnost linagliptin
The full EPAR for Trajenta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Trajenta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Trajenta. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Trajenta.
• metformin and a sulphonylurea; 
• metformin in sulfonilsečnina;
For more information about treatment with Trajenta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Trajenta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefit has Trajenta shown during the studies? 
Kakšne koristi je zdravilo Trajenta izkazalo med študijami?
• insulin, either on its own or together with metformin. 
• insulin, bodisi kot samostojno zdravilo bodisi skupaj z metforminom.
In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment. 
V vseh študijah je bilo glavno merilo učinkovitosti sprememba ravni snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), po 24 tednih zdravljenja.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Trajenta. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Trajenta, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
However the benefit of adding Trajenta to pioglitazone treatment was not considered to have been sufficiently established. 
Koristi dodajanja zdravila Trajenta zdravljenju s pioglitazonom pa niso bile zadostno dokazane.
Together, these processes reduce blood glucose levels and help to control type 2 diabetes. 
Ti procesi skupaj znižajo raven glukoze v krvi in pripomorejo k vzpostavitvi nadzora nad sladkorno boleznijo tipa 2.
Trajenta must not be used in people who are hypersensitive (allergic) to linagliptin or to any of the other ingredients. 
Zdravila Trajenta ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) linagliptin ali katero koli drugo sestavino zdravila.
Trajenta is a medicine that contains the active substance linagliptin. 
Trajenta je zdravilo, ki vsebuje zdravilno učinkovino linagliptin.
What is the risk associated with Trajenta? 
Kakšna tveganja so povezana z zdravilom Trajenta?
The most frequently reported side effect, seen in around 6 out of 100 patients taking Trajenta, was hypoglycaemia. 
Najpogostejši neželeni učinek jemanja zdravila Trajenta, o katerem so poročali pri približno 6 bolnikih od 100, je bila hipoglikemija.
The active substance in Trajenta, linagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor. 
Zdravilna učinkovina v zdravilu Trajenta, linagliptin, je zaviralec dipeptidil peptidaze 4 (DPP-4).
The Committee therefore concluded that the benefits of Trajenta outweigh its risks and recommended that it be granted marketing authorisation. 
CHMP je zato zaključil, da koristi zdravila Trajenta odtehtajo z njim povezana tveganja, in priporočil, da se zanj odobri dovoljenje za promet.
Hypoglycaemia was seen in around 15 out of 100 patients treated with the triple combination of Trajenta with metformin and a sulphonylurea (around twice as many as the placebo group). 
Hipoglikemijo so opazili pri okoli 15 bolnikih od 100, ki so jih zdravili s trojno kombinacijo zdravila Trajenta, metformina in sulfonilsečnine (okoli dvakrat več primerov kot v skupini, ki je prejemala placebo).
Trajenta was shown to be more effective than placebo at reducing HbA1c levels in all combinations studied: 
Zdravilo Trajenta je bilo pri zniževanju ravni HbA1c učinkovitejše od placeba v vseh proučevanih kombinacijah:
Five main studies in patients with type 2 diabetes were carried out with Trajenta, comparing the medicine with placebo (a dummy treatment) in combination with metformin (701 patients), in combination with metformin plus a sulphonylurea (1,058 patients), in combination with another antidiabetes medicine pioglitazone (389 patients) and in combination insulin with or without metformin and/or pioglitazone (1235 patients). 
Z zdravilom Trajenta je bilo izvedenih pet glavnih študij pri bolnikih s sladkorno boleznijo tipa 2, v katerih so zdravilo primerjali s placebom (zdravilom brez zdravilne učinkovine) v kombinaciji z metforminom (pri 701 bolniku), v kombinaciji z metforminom in sulfonilsečnino (pri 1 058 bolnikih), v kombinaciji z drugim zdravilom za zdravljenje sladkorne bolezni, pioglitazonom (pri 389 bolnikih), in v kombinaciji z insulinom ob sočasnem jemanju metformina in/ali pioglitazona ali brez njiju (pri 1 235 bolnikih).
Results from studies show that the overall risk of side effects were similar between Trajenta and placebo: (63% versus 60%). 
Rezultati študij kažejo, da je celokupno tveganje za pojav neželenih učinkov pri uporabi zdravila Trajenta podobno tveganju pri uporabi placeba (63 % v primerjavi s 60 %).
Linagliptin does not work when the blood glucose is low. 
Linagliptin namreč nima učinka, kadar je raven glukoze v krvi nizka.
Trajenta on its own was also shown to be effective compared with placebo and was considered appropriate for patients who cannot take metformin either due to intolerance or because they have kidney problems. 
Samostojno zdravljenje z zdravilom Trajenta je bilo prav tako učinkovito v primerjavi s placebom in se je štelo kot primerno za bolnike, ki ne smejo jemati metformina, ker ga ne prenašajo ali ker imajo težave z ledvicami.
Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. 
Prav tako zmanjšuje količino glukoze, ki jo tvorijo jetra, tako da poveča raven insulina in zmanjša raven hormona glukagona.
The overall risk of side effects with Trajenta was mostly comparable to placebo and the medicine's safety is similar to that of other dipeptidyl peptidase 4 (DPP-4) inhibitor medicines. 
Skupno tveganje za pojav neželenih učinkov pri jemanju zdravila Trajenta je bilo večinoma primerljivo s tveganjem pri placebu, varnost zdravila pa je podobna varnosti drugih zdravil, ki vsebujejo zaviralce dipeptidil peptidaze (DPP-4).
Why has Trajenta been approved? 
Zakaj je bilo zdravilo Trajenta odobreno?
Trajenta was also compared with placebo when used on its own in 503 patients. 
Zdravilo Trajenta so pri 503 bolnikih primerjali tudi s samostojno uporabljenim placebom.
For the full list of all side effects reported with Trajenta, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Trajenta, glejte navodilo za uporabo.
When added to metformin the dose of metformin should remain unchanged, however when combined with a sulphonylurea or insulin, a lower dose of the sulphonylurea or insulin may be considered because of the risk of hypoglycaemia (low blood sugar). 
Kadar se zdravilo dodaja metforminu, mora odmerek metformina ostati enak, pri kombinaciji s sulfonilsečnino ali insulinom pa je morda treba zmanjšati odmerek sulfonilsečnine ali insulina, da se zmanjša tveganje hipoglikemije (nizke ravni sladkorja v krvi).
By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. 
Linagliptin s podaljševanjem delovanja inkretinskih hormonov v krvi spodbuja trebušno slinavko k tvorjenju večje količine insulina, kadar so ravni glukoze v krvi visoke.
This gives an indication of how well blood glucose is controlled. 
Ta kaže, kako dobro je raven glukoze v krvi uravnana.
Trajenta is also used on its own in patients whose blood sugar levels are not adequately controlled by diet and exercise alone and who cannot be treated with metformin because they cannot tolerate it or because they have kidney problems. 
Zdravilo Trajenta se kot samostojno zdravilo uporablja tudi pri bolnikih, pri katerih samo z dieto in telesno vadbo ni mogoče zadovoljivo uravnati sladkorja v krvi in ki se ne smejo zdraviti z metforminom, ker ga ne prenašajo ali imajo težave z ledvicami.
Trajenta was also more effective than placebo when used on its own, reducing HbA1c levels by 0.46 percentage points compared with a rise of 0.22 percentage points seen with placebo. 
Zdravilo Trajenta je bilo učinkovitejše tudi od samostojno uporabljenega placeba, saj so se ravni HbA1c pri uporabi zdravila Trajenta znižale za 0,46 odstotne točke, medtem ko so se pri uporabi placeba povečale za 0,22 odstotne točke.
Based on the results of the main studies, the CHMP concluded that significant benefits in controlling blood glucose levels were seen in the combinations of Trajenta with metformin, with metformin plus a sulphonylurea, and with insulin with or without metformin. 
Na podlagi rezultatov glavnih študij je CHMP zaključil, da so bile pri jemanju zdravila Trajenta v kombinaciji z metforminom, v kombinaciji z metforminom in sulfonilsečnino in v kombinaciji z insulinom ob sočasnem jemanju metformina ali brez njega opažene pomembne koristi pri uravnavanju ravni glukoze v krvi.
Trajenta is used to treat type 2 diabetes with the following antidiabetes medicines when blood sugar levels are not already adequately controlled by diet, exercise and these antidiabetes medicines taken alone: 
Zdravilo Trajenta se uporablja za zdravljenje sladkorne bolezni tipa 2 v kombinaciji s spodaj navedenimi zdravili za zdravljenje sladkorne bolezni, kadar raven sladkorja v krvi ni zadovoljivo uravnana z dieto, telesno vadbo in jemanjem zadevnih zdravil kot samostojnih zdravil:
How has Trajenta been studied? 
Kako je bilo zdravilo Trajenta raziskano?
• when used in combination with a metformin plus a sulphonylurea, a reduction of 0.72 percentage points was seen with Trajenta compared with a reduction of 0.10 percentage points with placebo; 
• pri uporabi zdravila Trajenta v kombinaciji z metforminom in sulfonilsečnino so zabeležili znižanje za 0,72 odstotne točke v primerjavi s porastom za 0,10 odstotne točke v kombinaciji s placebom;
• when used in combination with metformin, a reduction of 0.56 percentage points was seen with 
• pri uporabi zdravila Trajenta v kombinaciji z metforminom so zabeležili znižanje za 0,56 odstotne
What is Trajenta used for? 
Za kaj se zdravilo Trajenta uporablja?
How is Trajenta used? 
Kako se zdravilo Trajenta uporablja?
• in combination with insulin with or without metformin and/or pioglitazone, a reduction of 0.55 
• pri uporabi zdravila Trajenta v kombinaciji z insulinom ob sočasni uporabi metformina in/ali pioglitazona so zabeležili znižanje za 0,55 odstotne točke v primerjavi s porastom za 0,10 odstotne točke v kombinaciji s placebom.
• in combination with pioglitazone, a reduction of 1.25 percentage points was seen with Trajenta compared with a reduction of 0.75 percentage points with placebo; 
• pri uporabi zdravila Trajenta v kombinaciji s pioglitazonom so zabeležili znižanje za 1,25 odstotne
What is Trajenta? 
Kaj je zdravilo Trajenta?
How does Trajenta work? 
Kako zdravilo Trajenta deluje?
• Educational brochure 
• izobraževalno knjižico,
• Summary of Product Characteristics (SPC) and Package Leaflet and Labelling 
• Povzetek glavnih značilnosti zdravila (SPC), Navodilo za uporabo in Označevanje.
• Brief background on Tasigna, its authorised indication and posology 
• kratek opis zdravila Tasigna, njegovih odobrenih indikacij in odmerjanja,
• The need to inform patients about the effects of food on Tasigna o Not to eat within two hours before and one hour after taking Tasigna o The need to avoid foods such as grapefruit juice which inhibit CYP3A4 enzymes 
• da je treba bolnike obvestiti o vplivu hrane na zdravilo Tasigna in sicer: o naj ne jedo dve uri pred zaužitjem zdravila Tasigna in eno uro po njem, o naj se izogibajo uživanju živil, kot je grenivkin sok, ki zavira encime CYP3A4.
The MAH shall ensure that prior to launch, all doctors who intend to prescribe Tasigna, and all pharmacists who may dispense Tasigna, are provided with a healthcare professional information pack containing the following: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo pred prihodom zdravila na tržišče vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Tasigna, in vsi lekarnarji, ki bodo lahko izdajali zdravilo Tasigna, prejeli komplet podatkov za strokovno zdravstveno osebje, ki bo vseboval sledeče:
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES 
POGOJI ALI OMEJITVE, KI SO V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA POSTAVLJENI DRŽAVAM ČLANICAM
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: 
Države članice morajo zagotoviti, da se vzpostavijo vsi pogoji oziroma omejitve glede varne in učinkovite uporabe zdravila, kot so opisani spodaj:
Key elements to be included in the educational brochure 
Izobraževalna knjižica mora vsebovati sledeče ključne vsebine:
ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES 
DODATEK POGOJI ALI OMEJITVE, KI JIH MORAJO V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA ZAGOTOVITI DRŽAVE ČLANICE
• Information on the cardiac risks associated with the use of Tasigna o That Tasigna can cause prolongation of the QT interval and that patients at risk of arrythmia, especially torsade de pointes, should not be prescribed Tasigna. 
• informacije o tveganju za srce v povezavi z uporabo zdravila Tasigna in sicer: o da zdravilo Tasigna lahko povzroča podaljšanje intervala QT in da se ga ne sme predpisovati bolnikom s tveganjem za aritmije, še posebno ne tistim s tveganjem za torsade de pointes, o da se je treba izogibati predpisovanju sočasne uporabe drugih zdravil, ki bi lahko podaljševala interval QT, o da je potrebna previdnost pri predpisovanju zdravila bolnikom z anamnezo koronarne bolezni ali s tveganjem za zanjo, o da zdravilo Tasigna lahko povzroča zastajanje tekočine, popuščanje srca in pljučni edem,
• That Tasigna is metabolised by CYP3A4 and that strong inhibitors or inducers of this enzyme may significantly affect exposure to Tasigna. 
• da se zdravilo Tasigna presnavlja s CYP3A4 in da močni zaviralci ali induktorji tega encima lahko pomembno vplivajo na izpostavljenost zdravilu Tasigna: o da zaviralci lahko povečajo možnost neželenih učinkov, še posebno podaljšanja intervala QT, o da je treba bolnike opozoriti glede uporabe zdravil brez recepta, še posebno šentjanževke,
The tablet should be swallowed whole with a little water. 
Tableto je treba pogoltniti celo z malo vode.
The European Commission granted a marketing authorisation valid throughout the EU for Tandemact on 8 January 2007. 
Evropska komisija je dovoljenje za promet z zdravilom Tandemact, veljavno po vsej Evropski uniji, izdala 8. januarja 2007.
The usual dose of Tandemact is one tablet once a day, taken just before or with the first meal of the day. 
Običajni odmerek zdravila Tandemact je ena tableta enkrat dnevno tik pred ali med prvim dnevnim obrokom.
Other information about Tandemact 
Druge informacije o zdravilu Tandemact
The patients' HbA1c levels fell from a baseline of over 7.5% by between 1.22 and 1.64%. 
Njihove ravni HbA1c so z izhodiščne vrednosti nad 7,5 % padle od 1,22 do 1,64 %.
Because pioglitazone has been approved in the European Union (EU) since 2000 under the name Actos, and glimepiride is already used in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature. 
Ker je pioglitazon v Evropski uniji (EU) odobren od leta 2000 pod imenom Actos in ker se glimepirid uporablja v že odobrenih zdravilih v EU, je družba predložila podatke iz predhodnih študij in objavljene literature.
The full EPAR for Tandemact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tandemact je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Tandemact? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tandemact?
It is available as tablets (30 mg pioglitazone and 2 or 4 mg glimepiride, or 45 mg pioglitazone and 4 mg glimepiride). 
Na voljo je v obliki tablet (30 mg pioglitazona in 2 mg ali 4 mg glimepirida oziroma 45 mg pioglitazona in 4 mg glimepirida).
At least 64% of the patients treated were classified as ‘responders', since their HbA1c levels either fell by at least 0.6% from the baseline value over the course of the studies, or their HbA1c levels were 6.1% or less at the end of the studies. 
Vsaj 64 % zdravljenih bolnikov je bilo razvrščenih med „odzivne bolnike“, ker so njihove ravni Hb1Ac med trajanjem študije padle za vsaj 0,6 % izhodiščne vrednosti, ali pa so njihove ravni HbA1c ob koncu študije znašale 6,1 % ali manj.
This is a summary of the European public assessment report (EPAR) for Tandemact. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tandemact.
Treatment with Tandemact should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. 
Zdravljenje z zdravilom Tandemact je treba ponovno oceniti po treh do šest mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, prekiniti.
For more information about treatment with Tandemact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Tandemact preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Tandemact pioglitazone and glimepiride 
Tandemact pioglitazon in glimepirid
What benefit has Tandemact shown during the studies? 
Kakšne koristi je zdravilo Tandemact izkazalo med študijami?
The most common side effects with Tandemact (seen in between 1 and 10 patients in 100) are upper respiratory tract infections (such as colds), hypoaesthesia (reduced sense of touch), bone fractures, weight gain, dizziness, flatulence (gas) and oedema (swelling). 
Najpogostejši neželeni učinki zdravila Tandemact (opaženi pri 1 do 10 bolnikih od 100) so okužba zgornjih dihal (prehladi), hipestezija (zmanjšan občutek za dotik), zlomi kosti, povečanje telesne mase, vrtoglavica, napenjanje (vetrovi) in edem (oteklina).
The studies included 1,390 patients who added pioglitazone to their existing treatment with a sulphonylurea. 
V te študije je bilo vključenih 1 390 bolnikov, ki so pioglitazon dodajali svojemu že obstoječemu zdravljenju s sulfonilsečnino.