FrancophonIA/ELRC3.0 huggingface dataset:
English: What Pioglitazone Krka is and what it is used for What you need to know before you take Pioglitazone Krka How to take Pioglitazone Krka Possible side effects
Slovenian: Kaj je zdravilo Pioglitazone Krka in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Pioglitazone Krka Kako jemati zdravilo Pioglitazone Krka Možni neželeni učinki
English: Environmental Risk Assessment (ERA): no environmental impact is anticipated from the clinical use of pioglitazone.
Slovenian: Ocena tveganja za okolje: ob klinični uporabi pioglitazona ni pričakovati vpliva na okolje.
English: Take Pioglitazone Krka tablets daily as prescribed.
Slovenian: Zdravilo Pioglitazone Krka jemljite vsak dan, kakor vam je predpisano.
English: Proportional increases of the plasma concentration were observed for doses from 2 - 60 mg.
Slovenian: Za odmerke od 2 do 60 mg so opažali sorazmerna povišanja plazemskih koncentracij.
English: The Prescriber Guide should highlight the following: - Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit.
Slovenian: Priročnik za predpisovanje zdravila mora izpostavljati: - kriterije izbora bolnikov, vključno z navodilom, da pioglitazona ne smemo uporabljati kot zdravilo prve izbire.
English: If you are following a diabetic diet, you should continue with this while you are taking Pioglitazone Krka.
Slovenian: Če ste na diabetični dieti, jo med jemanjem zdravila Pioglitazone Krka nadaljujte.
English: In animal fertility studies there was no effect on copulation, impregnation or fertility index.
Slovenian: Plodnost V študijah plodnosti pri živalih ni bilo vpliva na parjenje, oploditev ali rodnost.
English: common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Slovenian: pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - okužba dihal - motnje vida - povečanje telesne mase - otopelost občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - vnetje sinusov (sinusitis) - težave s spanjem (nespečnost)
English: Talk to your doctor before taking Pioglitazone Krka: - if you retain water (fluid retention) or have heart failures problems in particular if you are over
Slovenian: Pred začetkom jemanja zdravila Paglitaz se posvetujte z zdravnikom - če zadržujete vodo (zastajanje tekočine v telesu) ali imate probleme s srčnim popuščanjem,
English: If you have the impression that the effect of Pioglitazone Krka is too weak, talk to your doctor.
Slovenian: Če menite, da je učinek zdravila Pioglitazone Krka prešibak, se posvetujte z zdravnikom.
English: Similar changes were seen in metformin (haemoglobin 3 - 4% and haematocrit 3.6 - 4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1 - 2% and haematocrit 1 - 3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Slovenian: Podobne spremembe so opažali v primerjalnih kontroliranih preskušanjih s pioglitazonom pri bolnikih, zdravljenih z metforminom (hemoglobin 3-4 % in hematokrit 3,6-4,1 % relativna znižanja), in v manjšem obsegu pri bolnikih, zdravljenih s sulfonilsečnino in insulinom (hemoglobin 1-2 % in hematokrit 1-3,2 % relativna znižanja).
English: Excipient with known effect: Each tablet contains 176.46 mg of lactose (see section 4.4).
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 176,46 mg laktoze (glejte poglavje 4.4).
English: Excipient with known effect: Each tablet contains 88.83 mg of lactose (see section 4.4).
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 88,83 mg laktoze (glejte poglavje 4.4).
English: In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides.
Slovenian: V 20-tedenski študiji je pioglitazon znižal raven trigliceridov na tešče, pa tudi hipertrigliceridemijo po broku prek učinkovanja na absorbirane in v jetrih sintetizirane trigliceride.
English: In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDLcholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Slovenian: V večini kliničnih preskušanj so opažali znižane skupne plazemske koncentracije trigliceridov in prostih maščobnih kislin ter povišane ravni HDL holesterola v primerjavi s placebom, z majhnimi, vendar ne klinično značilnimi povišanji ravni LDL holesterola.
English: What you need to know before you take Pioglitazone Krka
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Pioglitazone Krka
English: A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Slovenian: Opravljena je bila skupna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8100 bolnikov v skupini zdravljeni s pioglitazonom in 7400 v skupini zdravljeni s primerjalnim zdravilom, ki so trajale do 3,5 let.
English: Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 times the upper limit of normal) or with any other evidence of liver disease.
Slovenian: Pri bolnikih s povišanimi izhodiščnimi ravnmi jetrnih encimov (ALT > 2,5-kratna zgornja meja normalnih vrednosti) ali s kakršnimikoli drugimi znaki jetrne bolezni zdravljenja s pioglitazonom ne smemo začeti.
English: Lactose monohydrate Hydroxypropylcellulose (E463) Croscarmellose sodium Magnesium stearate (E572)
Slovenian: 6.1 Seznam pomožnih snovi laktoza monohidrat hidroksipropilceluloza (E463) premreženi natrijev karmelozat magnezijev stearat (E572)
English: In patients with renal impairment, plasma concentrations of pioglitazone and its metabolites are lower than those seen in subjects with normal renal function, but oral clearance of parent substance is similar.
Slovenian: Pri bolnikih z ledvično okvaro so plazemske koncentracije pioglitazona in njegovih presnovkov nižjekot pri osebah z normalnim delovanjem ledvic, vendar je peroralni očistek izvorne učinkovinepodoben.
English: However if you miss a dose, just carry on with the next dose as normal.Do not take a double dose to make up for a forgotten tablet.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
English: Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Pioglitazone Krka.
Slovenian: Rak mehurja se lahko pojavi občasno (pojavijo se lahko pri največ 1 od 100 bolnikov) pri bolnikih, ki jemljejo zdravilo Pioglitazone Krka.
English: Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking Pioglitazone Krka in combination with insulin.
Slovenian: Odpoved srca je bila pogosto (pojavijo se lahko pri največ 1 od 10 bolnikov) ugotovljena pri bolnikih, ki so jemali Pioglitazone Krka v kombinaciji z insulinom.
English: In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Slovenian: V kliničnih preskušanjih pioglitazona je bila incidenca povišanih vrednosti ALT, višjih kot trikratna zgornja meja normalnih vrednosti, enaka kot pri placebu, vendar nižja kot v primerjalnih skupinah z metforminom ali sulfonilsečnino.
English: In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 - 3 kg over one year.
Slovenian: V kontroliranih preskušanjih s primerjalnim zdravilom je bilo povprečno povečanje telesne mase pri pioglitazonu, dajanemu kot monoterapija, 2-3 kg v enem letu.
English: Excipient with known effect: Each tablet contains 264.68 mg of lactose (see section 4.4).
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 264,68 mg laktoze (glejte poglavje 4.4).
English: Eye disorders visual disturbance common common uncommon macular oedema not known not known not known not known not known
Slovenian: Očesne bolezni motnje vida občasni makularni edem 3 neznana neznana neznana neznana neznana
English: 14 tablets: EU/1/11/723/001 28 tablets: EU/1/11/723/002 30 tablets: EU/1/11/723/003 56 tablets: EU/1/11/723/004 60 tablets: EU/1/11/723/005 90 tablets: EU/1/11/723/006 98 tablets: EU/1/11/723/007
Slovenian: 14 tablet: EU/1/11/723/001 28 tablet: EU/1/11/723/002 30 tablet: EU/1/11/723/003 56 tablet: EU/1/11/723/004 60 tablet: EU/1/11/723/005 90 tablet: EU/1/11/723/006 98 tablet: EU/1/11/723/007
English: 14 tablets: EU/1/11/723/015 28 tablets: EU/1/11/723/016 30 tablets: EU/1/11/723/017 56 tablets: EU/1/11/723/018 60 tablets: EU/1/11/723/019 90 tablets: EU/1/11/723/020 98 tablets: EU/1/11/723/021
Slovenian: 14 tablet: EU/1/11/723/015 28 tablet: EU/1/11/723/016 30 tablet: EU/1/11/723/017 56 tablet: EU/1/11/723/018 60 tablet: EU/1/11/723/019 90 tablet: EU/1/11/723/020 98 tablet: EU/1/11/723/021
English: - This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
Slovenian: - Namen tega izobraževalnega paketa je povečati zavedanje o pomembnih znanih tveganjih za nastanek raka mehurja in srčnega popuščanja, ter celokupna priporočila, namenjena optimizaciji meje med koristjo in tveganjem pri vsakem bolniku, - Izobraževalni paket za zdravnika mora vsebovati: Povzetek glavnih značilnosti zdravila, navodilo za uporabo in priročnik za predpisovanje zdravila.
English: How to take Pioglitazone Krka
Slovenian: Kako jemati zdravilo Pioglitazone Krka
English: 14 tablets: EU/1/11/723/008 28 tablets: EU/1/11/723/009 30 tablets: EU/1/11/723/010 56 tablets: EU/1/11/723/011 60 tablets: EU/1/11/723/012 90 tablets: EU/1/11/723/013 98 tablets: EU/1/11/723/014
Slovenian: 14 tablet: EU/1/11/723/008 28 tablet: EU/1/11/723/009 30 tablet: EU/1/11/723/010 56 tablet: EU/1/11/723/011 60 tablet: EU/1/11/723/012 90 tablet: EU/1/11/723/013 98 tablet: EU/1/11/723/014
English: How to store Pioglitazone Krka Contents of the pack and other information
Slovenian: Shranjevanje zdravila Pioglitazone Krka Vsebina pakiranja in dodatne informacije
English: The risk of fractures should be considered in the long term care of women treated with pioglitazone.
Slovenian: Pri dolgoročnem zdravljenju žensk s pioglitazonom je potrebno upoštevati tveganje za zlome.
English: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1, - cardiac failure or history of cardiac failure (NYHA stages I to IV), - hepatic impairment, - diabetic ketoacidosis, - current bladder cancer or a history of bladder cancer, - uninvestigated macroscopic haematuria.
Slovenian: - s srčnim popuščanjem ali srčnim popuščanjem v anamnezi (NYHA razredi od I do IV), - z okvarjenim delovanjem jeter, - z diabetično ketoacidozo, - z rakom mehurja ali rakom mehurja v anamnezi, - z neraziskano makroskopsko hematurijo.
English: Pioglitazone Krka contains pioglitazone.
Slovenian: Zdravilo Pioglitazone Krka vsebuje pioglitazon.
English: There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Slovenian: V obdobju trženja so poročali o primerih srčnega popuščanja, ko so pioglitazon uporabljali v kombinaciji z insulinom ali pri bolnikih s srčnim popuščanjem v anamnezi.
English: Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Krka.
Slovenian: Zdravnik vas bo v času zdravljenja z zdravilom Pioglitazone Krka naročil na redne preiskave krvi.
English: Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience.
Slovenian: V okviru izkušenj v obdobju trženja so se pojavljali redki primeri povišanih vrednosti jetrnih encimov in hepatocelularne disfunkcije.
English: - 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)
Slovenian: - zelo redki (< 1/10.000), - neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The other side effects that have been experienced by some patients when Pioglitazone Krka is taken with other antidiabetic medicines are:
Slovenian: Pri nekaterih bolnikih, ki so jemali zdravilo Pioglitazone Krka skupaj z drugimi antidiabetičnimi zdravili, so se pojavili naslednji drugi neželeni učinki:
English: Date of first authorisation: 21 March 2012 Date of latest renewal: DD month YYYY
Slovenian: Datum prve odobritve: 21. marec 2012
English: White to almost white round tablets with bevelled edges (diameter 8.0 mm).
Slovenian: Bele do skoraj bele, okrogle tablete s prirezanimi robovi (premer 8,0 mm).
English: - The risk bladder cancer and relevant risk minimisation advice.
Slovenian: - tveganje za nastanek raka mehurja ter ustrezne nasvete za zmanjševanje tveganja - tveganje za nastanek srčnega popuščanja ter ustrezne nasvete za zmanjševanje tveganja - previdnost pri uporabi zdravila pri starejših bolnikih glede tveganj, ki so povezana s starostjo
English: If you forget to take Pioglitazone Krka
Slovenian: Če ste pozabili vzeti zdravilo Pioglitazone Krka
English: - if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).
Slovenian: zlasti če ste starejši od 75 let; - če imate poseben tip diabetične očesne bolezni, imenovane makularni edem (oteklina očesnega ozadja); - če imate ciste na jajčnikih (sindrom policističnih jajčnikov).
English: Pioglitazone Krka may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Slovenian: Zdravilo Pioglitazone Krka lahko uporabljamo samo pri bolnikih, ki ne morejo jemati metformina, in ko zdravljenje z dieto in telesno vadbo ni uspešno pri nadzoru krvnega sladkorja.
English: Musculoskeletal and connective tissue disorders fracture bone common common common common common arthralgia common common back pain common
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva zlomi kosti artralgija bolečine v hrbtu
English: Blurred vision due to swelling (or fluid) at the back of the eye (frequency not known) has also been reported in patients taking Pioglitazone Krka.
Slovenian: Bolniki, ki so jemali Pioglitazone Krka, so poročali tudi o zamegljenem vidu zaradi otekanja (ali tekočine) očesnega ozadja (pogostnost ni poznana).
English: Since insulin and pioglitazone are both associated with fluid retention,
Slovenian: Ker sta insulin in pioglitazon povezana z zastajanjem tekočine, lahko sočasno jemanje poveča tveganje za edeme.
English: White to almost white round tablets with bevelled edges and with engraved "45" on one side of tablet (diameter 10.0 mm).
Slovenian: Bele do skoraj bele, okrogle tablete s prirezanimi robovi in z oznako ‘45' na eni strani (premer 10,0 mm).
English: Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon
Slovenian: Infekcijske in parazitske bolezni okužba zgornjih dihal bronhitis sinusitis občasni občasni občasni
English: What Pioglitazone Krka contains - The active substance is pioglitazone.
Slovenian: Kaj vsebuje zdravilo Pioglitazone Krka - Zdravilna učinkovina je pioglitazon.
English: What Pioglitazone Krka looks like and contents of the pack White to almost white round tablets with bevelled edges (diameter 8.0 mm).
Slovenian: Izgled zdravila Pioglitazone Krka in vsebina pakiranja Bele do skoraj bele, okrogle tablete s prirezanimi robovi (premer 8,0 mm).
English: Cardiac disorders heart failure common
Slovenian: Srčne bolezni srčno popuščanje
English: White to almost white round tablets with bevelled edges and with engraved "15" on one side of tablet (diameter 7.0 mm).
Slovenian: Bele do skoraj bele, okrogle tablete s prirezanimi robovi in z oznako ‘15' na eni strani (premer 7,0 mm).
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Slovenian: Pri tiazolidindionih, vključno s pioglitazonom, so v poročilih v obdobju trženja poročali o novonastalih ali poslabšanjih diabetičnega makularnega edema z zmanjšanjem vidne ostrine.
English: Pioglitazone Krka 30 mg tablets
Slovenian: Pioglitazone Krka 30 mg tablete
English: Pioglitazone Krka 45 mg tablets
Slovenian: Pioglitazone Krka 45 mg tablete
English: Investigations weight increased common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon
Slovenian: Preiskave povečanje telesne mase povišana vrednost kreatin fosfokinaze v krvi povišana vrednost laktatne dehidrogenaze občasni zvišana vrednost alanin neznana neznana neznana neznana neznana
English: Allergic reactions have been reported (frequency not known) in patients taking Pioglitazone Krka.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Pioglitazone Krka, so poročali o alergijskih reakcijah (pogostnost ni znana).
English: Pioglitazone Krka tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: What Pioglitazone Krka looks like and contents of the pack White to almost white round tablets with bevelled edges and with engraved "45" on one side of tablet (diameter 10.0 mm).
Slovenian: Izgled zdravila Pioglitazone Krka in vsebina pakiranja Bele do skoraj bele, okrogle tablete s prirezanimi robovi in z oznako ‘45' na eni strani (premer 10,0 mm).
English: Other medicines and Pioglitazone Krka
Slovenian: Druga zdravila in zdravilo Pioglitazone Krka
English: Do not take Pioglitazone Krka: - if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Pioglitazon je kontraindiciran pri bolnikih: - s preobčutljivostjo na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju
English: What Pioglitazone Krka looks like and contents of the pack White to almost white round tablets with bevelled edges and with engraved "15" on one side of tablet (diameter 7.0 mm).
Slovenian: Izgled zdravila Pioglitazone Krka in vsebina pakiranja Bele do skoraj bele, okrogle tablete s prirezanimi robovi in z oznako ‘15' na eni strani (premer 7,0 mm).
English: Pioglitazone Krka 15 mg tablets
Slovenian: Pioglitazone Krka 15 mg tablete
English: If you stop using Pioglitazone Krka tablets, your blood sugar may go up.
Slovenian: Če ste prenehali jemati zdravilo Pioglitazone Krka, se vam lahko raven krvnega sladkorja zviša, zato se posvetujte z zdravnikom, preden prenehate s tem zdravljenjem.
English: Frequencies are defined as: - 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)
Slovenian: Neželeni učinki, o katerih so poročali večkrat (> 0,5%) kot pri placebu in več kot enkrat pri bolnikih, ki so prejemali pioglitazon v dvojno slepih študijah, so našteti spodaj, in sicer po razredih organskih sistemov in absolutni pogostnosti, kot je priporočeno po MedDRA. Pogostnosti so določene kot: - 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),
English: Pioglitazone Krka 45 mg tablets Pioglitazone
Slovenian: Pioglitazone Krka 45 mg tablete pioglitazon
English: Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin fatigue uncommon
Slovenian: Kombinacija z metforminom s sulfonilsečnino z metforminom in sulfonilsečnino z insulinom aminotransferaze
English: Pioglitazone Krka 15 mg tablets Pioglitazone
Slovenian: Pioglitazone Krka 15 mg tablete pioglitazon
English: The other side effects that have been experienced by some patients taking Pioglitazone Krka are:
Slovenian: Pri nekaterih bolnikih, ki so jemali zdravilo Pioglitazone Krka, so se pojavili drugi neželeni učinki:
English: Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency.
Slovenian: Neželeni učinki, o katerih so poročali večkrat (> 0,5%) kot pri placebu in več kot enkrat pri bolnikih, ki so prejemali pioglitazon v dvojno slepih študijah, so našteti spodaj, in sicer po razredih organskih sistemov in absolutni pogostnosti, kot je priporočeno po MedDRA. Pogostnosti so določene kot: - 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),
English: Pioglitazone Krka 30 mg tablets Pioglitazone
Slovenian: Pioglitazone Krka 30 mg tablete pioglitazon
English: General disorders and administration site conditions oedema very common fatigue uncommon
Slovenian: Motnje reprodukcije in dojk erektilna disfunkcija Splošne težave in spremembe na mestu aplikacije edem zelo pogosti utrujenost občasni
English: Pioglitazone Krka tablets should be used every day to work properly.
Slovenian: Če ste prenehali jemati zdravilo Pioglitazone Krka Za pravilno delovanje je potrebno zdravilo Pioglitazone Krka jemati vsak dan.
English: Tel: + 49 (0) 4721 606-0
Slovenian: TAD Pharma GmbH Tel: + 49 (0) 4721 606-0
English: Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon
Slovenian: Kombinacija z metforminom s sulfonilsečnino z metforminom in sulfonilsečnino z insulinom novotvorbe (vključno s cistami in polipi) rak mehurja občasni občasni občasni občasni občasni
English: Localised swelling (oedema) has also been experienced very commonly in patients taking Pioglitazone Krka in combination with insulin.
Slovenian: Pri bolnikih, ki so jemali Pioglitazone Krka v kombinaciji z insulinom, je bilo zelo pogosto ugotovljeno lokalno otekanje (edemi).
English: Reproductive system and breast disorders erectile dysfunction common
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja
English: - Your kidneys do not work properly.
Slovenian: Vaše ledvice ne delujejo pravilno.
English: • Activated Clotting Time (ACT)
Slovenian: • Aktivirani čas strjevanja (ACT)
English: There are no adequate and well-controlled studies in pregnant women.
Slovenian: Ustreznih in dobro nadzorovanih študij pri nosečnicah ni.
English: Your doctor will discuss with you the risks and benefits of using this medicine.
Slovenian: Vaš zdravnik se bo z vami pogovoril o tveganjih in koristih tega zdravila.
English: Odds Ratio (95% CI)
Slovenian: Razmerje verjetnosti (95-% IZ)
English: Therefore interpretation of these observational studies is limited and an association between aprotinin use and increased mortality can neither be established nor refuted.
Slovenian: Zato je razlaga izsledkov teh opazovalnih študij omejena, povezave med uporabo aprotinina in povečano umrljivostjo pa ni mogoče niti potrditi, niti ovreči.
English: For adult patients the following dose regimen is recommended:
Slovenian: Za odrasle bolnike se priporoča naslednji režim odmerjanja
English: asthma (bronchospasm)
Slovenian: astma (bronhospazem)