natgillin/translations-raw huggingface dataset:
Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab.
Pri bolnikih, zdravljenih z adalimumabom, je bil v redkih primerih med obdobjem trženja identificiran hepatosplenični T-celični limfom.
Continued therapy should be reconsidered in a patient not responding within this time period.
Po 12 tednih je treba nadaljevanje zdravljenja pri bolniku, pri katerem v tem obdobju ni prišlo do
Placebo Adalimumab 40 mg Weekly
placebo adalimumab
Anaphylaxis
Imunosupresija
• sensation of heart beating rapidly;
• občutek siljenja na bruhanje, bruhanje;
p-value p-value p-value p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test.
Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U.
• Do not rub the injection site.
Stisnite mesto injiciranja
If these medicines do not work well enough, you will be given Cyltezo to reduce the signs and
Če ta zdravila ne bodo delovala dovolj dobro, boste za zmanjšanje znakov in simptomov bolezni dobili zdravilo Cyltezo.
40 mg Adalimumab every week
40 mg adalimumaba vsak teden n = 172
5) Clean injection site
11) Zavrzite napolnjeno injekcijsko brizgo
Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia pruritus
pogosti poslabšanje ali pojav psoriaze (vključno s palmplantarno pustularno psoriazo) urtikarija, modrice (vključno s purpuro), dermatitis (vključno z ekcemom), oniholiza, čezmerno znojenje, alopecija srbenje nočno potenje, brazgotinjenje multiformni eritem Stevens-Johnsonov sindrom angioedem kožni vaskulitis lihenoidna reakcija poslabšanje simptomov dermatomiozitisa mišično-skeletne bolečine mišični spazmi (vključno s povišano kreatin fosfokinazo v krvi)
Traceability
A. OZNAČEVANJE
Rare (may affect up to 1 in 1,000 people): • leukaemia (cancer affecting the blood and bone marrow);
• levkemija (rak, ki prizadene kri in kostni mozeg);
• facial oedema;
• kratka sapa;
In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:
≥ 40 kg • 80 mg v 0. tednu in 40 mg v 2. tednu V primeru, ko je potreben hitrejši odgovor na zdravljenje, z zavedanjem, da je tveganje za pojav neželenih učinkov povečano ob uporabi večjega začetnega odmerka, se lahko uporabi odmerek:
ACR Responses in Placebo-Controlled Trials (Percent of Patients) RA Study II a**
Preglednica 7: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov) Odziv
Diplopia
adalimumab
Adalimumab 40 mg eow N = 80
adalimumab 80/40 mg n = 75
RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks 40 mg adalimumab administered every other week
Študija revmatoidnega artritisa I po 24 tednih, študija revmatoidnega artritisa II po 26 tednih in študija revmatoidnega p < 0,01, adalimumab v prim.
The recommended Cyltezo dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1
Priporočeni odmerek zdravila Cyltezo je 80 mg v 0. tednu, ki mu sledi 40 mg vsak drugi teden z začetkom v 1. tednu, v obliki subkutane injekcije.
Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30 % plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab vs. placebo pairwise comparison of proportions ** p < 0.001 for adalimumab vs. placebo pairwise comparison of proportions
Klinični odgovor pomeni znižanje ocene Mayo od začetka za ≥ 3 in ≥ 30 % ter znižanje podocene rektalne krvavitve [RBS]
• 4 pre-filled syringes (0.8 mL sterile solution), each in a blister, with 4 alcohol pads.
• 4 napolnjene injekcijske brizge (0,8 ml sterilne raztopine), vsaka v svojem pretisnem omotu, s
• inflammations.
• hepatitis;
Hospitalisation rates
Celjenje sluznice
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
Če je potreben hitrejši odziv na zdravljenje, lahko uporabite shemo 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekcijia v enem dnevu).
• inflammation of the skin (such as eczema); • breaking of finger nails and toe nails;
• vnetje kože (kot je ekcem);
• 6 pre-filled syringes (0.8 mL sterile solution), each in a blister, with 6 alcohol pads.
• 6 napolnjenih injekcijskih brizg (0,8 ml sterilne raztopine), vsaka v svojem pretisnem omotu, s
Keep the syringes in the outer carton in order to protect from light.
Injekcijske brizge shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Napolnjene injekcijske peresnike shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Liver failure
Bat igle
Table 10:
Preglednica 11:
- Keep this leaflet.
Pokrovčka ne sučite.
Package leaflet: Information for the patient Cyltezo 40 mg solution for injection in pre-filled syringe Adalimumab
Navodilo za uporabo Cyltezo 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
There is no relevant use of adalimumab in patients aged less than 2 years for this indication.
Pri bolnikih, starih manj kot 2 leti, adalimumab za to indikacijo ni namenjen.
What Cyltezo is and what it is used for 2.
Kaj je zdravilo Cyltezo in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Cyltezo
Adalimumab 0.8 mg/kg eow N = 38
adalimumab 0,8 mg/kg vsak drugi teden n = 38
Headache
Konica
Patients treated with adalimumab usually experienced improvement in haematological signs of chronic inflammation.
Z adalimumabom zdravljenim bolnikom so se ponavadi izboljšali
Mean steady-state trough levels of approximately 7 μg/mL were observed in Crohn's disease patients who received a maintenance dose of 40 mg adalimumab every other week.
Pri bolnikih s Crohnovo boleznijo, ki so dobivali vzdrževalni odmerek 40 mg adalimumaba vsak drugi teden, so ugotovili najmanjšo koncentracijo v stanju dinamičnega ravnovesja približno 7 µg/ml.
2) Inspect pen
6) Odstranite pokrovček
Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Pri bolniku, ki se v tem času ne odzove na zdravljenje je treba ponovno razmisliti o nadaljevanju zdravljenja.
Age over 65 years
13 do 17 let
• 2 pre-filled syringes (0.8 mL sterile solution), each in a blister, with 2 alcohol pads.
• 2 napolnjeni injekcijski brizgi (0,8 ml sterilne raztopine), vsaka v svojem pretisnem omotu, z
• erythema multiforme (inflammatory skin rash);
• edem obraza povezan z alergijskimi reakcijami; • multiformni eritem (vnetje kožnega izpuščaja);
Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Psoriatični artritis in aksialni spondiloartritis, vključno z ankiloznim spondilitisom
Muscle spasms (including blood creatine phosphokinase increased)
Bolezni kože in podkožja zelo pogosti izpuščaj (vključno z eksfoliativnim izpuščajem)
p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in monoterapije z metotreksatom z Mann
Endpoint
ASDAS
Adults with non-infectious uveitis
Neinfekcijski uveitis pri odraslih in otrocih
- if you have blood in your urine that your doctor has not checked.
če imate kri v urinu, ki ga zdravnik ni preiskal.
- if you have or have ever had bladder cancer.
če imate ali ste kdaj imeli raka sečnega mehurja.
Your doctor will check whether Glustin is working 3 to 6 months after you start taking it.
Zdravnik bo preveril ali zdravilo Glustin deluje, 3 do 6 mesecev po tem, ko začnete jemati zdravilo.
Date of first authorisation: 11/10/2000 Date of latest renewal: 31/08/2010
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 11. oktober 2000 Datum zadnjega podaljšanja: 31. avgust 2010
not known not known not known not known not known
neznana neznana neznana neznana
Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Približno polovica populacije, vključene v študijo, je ustrezala vsaj dvema vstopnima kriterijema kardiovaskularne anamneze.
The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Starost populacije, vključene v študijo, je bila v povprečju 62 let; povprečno trajanje sladkorne bolezni je bilo 9,5 let.
You can usually continue to take other medicines whilst you are being treated with Glustin.
Običajno lahko še naprej jemljete druga zdravila, medtem ko se zdravite z zdravilom Glustin.
- if you have a problem with your liver or heart.
če imate težave z jetri ali s srcem.
Tell your doctor if - you are, you think you might be or are planning to become pregnant.
Povejte zdravniku če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev.
Your doctor will tell you the dose to take.
Zdravnik vam bo predpisal odmerek, ki ga morate jemati
Use in children and adolescents under 18 years is not recommended.
Otroci in mladostniki Uporaba tega zdravila pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
The safety and efficacy of Glustin in children and adolescents under 18 years of age have not been established.
Varnost in učinkovitost zdravila Glustin pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
Approximately one third of patients were receiving insulin in combination with metformin and/or a sulphonylurea.
Približno tretjina bolnikov je prejemala insulin v kombinaciji z metforminom in/ali sulfonilsečnino.
Glustin helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Zdravilo Glustin pomaga nadzorovati raven sladkorja v krvi, če imate sladkorno bolezen tipa 2, in sicer tako, da telesu pomaga bolje izkoristiti insulin, ki ga izdela.
What Glustin is and what it is used for
Kaj je zdravilo Glustin in za kaj ga uporabljamo
Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Skoraj polovica bolnikov je predhodno doživela miokardni infarkt in približno 20% jih je doživelo kap.
Glustin has no or negligible influence on the ability to drive and use machines.
Zdravilo Glustin nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Take Glustin daily as prescribed.
Zdravilo Glustin jemljite vsak dan, kakor vam je predpisano.
If you take Glustin with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Če zdravilo Glustin jemljete z drugimi zdravili za zdravljenje sladkorne bolezni, je bolj verjetno, da vrednost krvnega sladkorja pade pod normalno raven (hipoglikemija).
The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
Opazovano povečano tveganje za zlom pri ženskah v tej skupini podatkov na pioglitazonu je torej 0,8 zlomov na 100 bolniških let uporabe.
Talk to your doctor or pharmacist before taking Glustin (also see section 4) - if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old.
Pred začetkom jemanja zdravila Glustin se posvetujte z zdravnikom ali s farmacevtom (glejte tudi poglavje 4): - če zadržujete vodo (zastajanje tekočine v telesu) ali imate težave s srčnim popuščanjem, zlasti če ste starejši od 75 let.
not known (frequency cannot be estimated from the available data) - increase in liver enzymes - allergic reactions
neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) povišanje vrednosti jetrnih encimov alergijske reakcije
ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
PRILOGA IV ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJ (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Epidemiological studies have also suggested a small increased risk of bladder cancer in diabetic patients treated with pioglitazone, although not all studies identified a statistically significant increased risk.
Tudi epidemiološke študije kažejo tudi malo večje tveganje za rak mehurja pri bolnikih s sladkorno boleznijo zdravljenih s pioglitazonom, čeprav pri vseh študijah povečanje tveganja ni bilo statistično signifikantno.
Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, acetylsalicylic acid, statins, fibrates).
Skoraj vsi preiskovanci (95%) so prejemali kardiovaskularna zdravila (zaviralce adrenergičnih receptorjev beta, zaviralce angiotenzinske konvertaze (zaviralce ACE), antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, acetilsalicilno kislino, statine, fibrate).
Other medicines and Glustin
Druga zdravila in zdravilo Glustin
When Glustin is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Če boste zdravilo Glustin jemali skupaj z drugimi zdravili za zdravljenje sladkorne bolezni (kot so insulin, klorpropamid, glibenklamid, gliklazid, tolbutamid), vam bo zdravnik povedal, če morate jemati nižje odmerke teh zdravil.
Before you start taking Glustin you will have a blood sample taken to check your liver function.
Pred začetkom jemanja zdravila Glustin vam bodo odvzeli vzorec krvi, da se preveri delovanje jeter.
5 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
5 O edemih so poročali pri 6-9% bolnikov, zdravljenih s pioglitazonom leto dni v kontroliranih kliničnih preskušanjih.
Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs; excl. insulins; ATC code: A10BG03.
Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, antidiabetiki; oznaka ATC: A10BG03
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Glustin.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila Glustin posvetujte s svojim zdravnikom.
common common uncommon macular oedema not known not known not known not known not known
občasni makularni edem neznana neznana neznana neznana
If ALT levels are increased to 3 x upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Če se med zdravljenjem s pioglitazonom ravni ALT zvišajo do 3 kratne zgornje meje normalnih vrednosti, je treba ravni jetrnih encimov čim prej ponovno kontrolirati.
Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Čeprav je bila študija neuspešna v povezavi z primarnimi opazovanimi dogodki, ki so zajemali umrljivost zaradi vseh vzrokov, neusodne miokardne infarkte, kapi, akutne koronarne sindrome, težje amputacije nog, koronarne revaskularizacije in revaskularizacije nog, izsledki kažejo, da v zvezi z kardiovaskularnim sistemom ni dolgoročnih pomislekov glede uporabe pioglitazona.
What Glustin is and what it is used for What you need to know before you take Glustin How to take Glustin
Kaj je zdravilo Glustin in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Glustin Kako jemati zdravilo Glustin Možni neželeni učinki
If you have the impression that the effect of Glustin is too weak, talk to your doctor.
Če menite, da je učinek zdravila Glustin prešibak, se posvetujte z zdravnikom.
Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Bolniki, ki so prejemali pioglitazon, so imeli povprečno znižanje HbA1c za 0,45%, v primerjavi s tistimi, ki so nadaljevali zdravljenje samo z insulinom, in znižan odmerek insulina v skupini zdravljeni s pioglitazonom.
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Če ste vzeli večji odmerek zdravila Glustin, kot bi smeli Če po nesreči zaužijete preveč tablet ali če kdo drug ali otrok zaužije vaša zdravila, o tem nemudoma obvestite zdravnika ali farmacevta.
Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90 and 98 tablets.
Aluminij/aluminij pretisni omoti, pakiranja po 14, 28, 30, 50, 56, 84, 90 in 98 tablet.
On the basis of the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za glimepirid/pioglitazon hidroklorid, metformin/pioglitazon, pioglitazon odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zdravilno(-e) učinkovinoe glimepirid/pioglitazon hidroklorid, metformin/pioglitazon, pioglitazon{ime(-na) zdravilne(-ih) učinkovine(učinkovin)} nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Your doctor will ask you to have blood tests periodically during treatment with Glustin.
Zdravnik vas bo v času zdravljenja z zdravilom Glustin naročal na redne preiskave krvi.
The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 84, 90 or 98 tablets.
Tablete so na voljo v pretisnih omotih po 14, 28, 30, 50, 56, 84, 90 ali 98 tablet.
very common (may affect more than 1 in 10 people) - decreased blood sugar (hypoglycaemia)
zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) znižanje ravni krvnega sladkorja (hipoglikemija)
The other side effects that have been experienced by some patients taking Glustin are:
Drugi neželeni učinki, ki so se pojavili pri nekaterih bolnikih, ki so jemali zdravilo Glustin, so:
However, the incidences of oedema, weight gain and heart failure were increased.
Vendar je bila incidenca edemov, pridobivanja telesne mase in srčnih odpovedi povečana.
− The other ingredients are lactose monohydrate, hyprolose, carmellose calcium and magnesium stearate.
Pomožne snovi so laktoza monohidrat, hiproloza, kalcijev karmelozat in magnezijev stearat.
If you are following a special diet for diabetes, you should continue with this while you are taking Glustin.
Če ste na posebni dieti za sladkorno bolezen, morate z dieto med jemanjem zdravila Glustin nadaljevati.
In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included insulin.
V študiji za ocenitev izida pri bolnikih z že obstoječimi težjimi makrovaskularnimi boleznimi, je bila incidenca resnega srčnega popuščanja 1,6% višja s pioglitazonom kot s placebom, dodanim k zdravljenju, ki je vključevalo insulin.
The European Medicines Agency has waived the obligation to submit the results of studies with Glustin in all subsets of the paediatric population in type 2 diabetes mellitus.
Evropska agencija za zdravila je odstopila od zahteve za predložitve rezultatov študij z zdravilom Glustin za vse podskupine pediatrične populacije s sladkorno boleznijo tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets
14 tablet 28 tablet 30 tablet 50 tablet 56 tablet 84 tablet 90 tablet 98 tablet
- if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Glustin - če ste alergični na pioglitazon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
- if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss,
če ste imeli diabetično ketoacidozo (zaplet sladkorne bolezni, ki povzroča hitro hujšanje, siljenje na bruhanje ali bruhanje).
The improved glycaemic control is associated with a reduction in both fasting and postprandial plasma insulin concentrations.
Izboljšan nadzor glikemije je povezan z znižanjem plazemskih koncentracij insulina tako na tešče kot po obrokih.
The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Učinek pioglitazona (45 mg monoterapija v primerjavi s placebom) so preučevali v majhnem 18tedenskem preskušanju pri bolnikih s sladkorno boleznijo tipa 2.
The other side effects that have been experienced by some patients when Glustin is taken with other antidiabetic medicines are:
Drugi neželeni učinki, ki so se pojavili pri nekaterih bolnikih, ki so jemali zdravilo Glustin skupaj z drugimi antidiabetičnimi zdravili, so:
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Študijo s pioglitazonom, kjer so spremljali kardiovaskularni izid so opravili pri bolnikih, mlajših od 75 let, s sladkorno boleznijo tipa 2 in že obstoječimi težjimi makrovaskularnimi boleznimi.
If you forget to take Glustin
Če ste pozabili vzeti zdravilo Glustin
What Glustin looks like and contents of the pack
Izgled zdravila Glustin in vsebina pakiranja
common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness - increased appetite
pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) glavobol omotica bolečine v sklepih impotenca bolečine v hrbtu težko dihanje majhno znižanje števila rdečih krvnih celic vetrovi občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) sladkor v urinu, beljakovine v urinu povišanje vrednosti encimov občutek vrtenja (vrtoglavica) znojenje utrujenost povečan apetit
Environmental Risk Assessment (ERA) No environmental impact is anticipated from the clinical use of pioglitazone
Ocena tveganja za okolje: Pri klinični uporabi pioglitazona ni pričakovati vpliva na okolje
- 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
- s preobčutljivostjo na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 - 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
If you experience this symptom for the first time, talk to your doctor as soon as possible.
Če ste prvič opazili ta simptom, se čim prej posvetujte z zdravnikom.