natgillin/translations-raw huggingface dataset:
Severe, occasionally fatal, dermatologic reactions, including toxic epidermal necrolysis (Lyell's syndrome) or Stevens-Johnson syndrome have been reported after single or multiple doses of methotrexate.
Po enkratnem odmerku ali večkratnih odmerkih metotreksata so poročali o hudih, občasno smrtnih dermatoloških reakcijah, vključno s toksično epidermalno nekrolizo (Lyellovim sindromom) ali
The doctor may increase the dose if the used dose is not effective but tolerated well.
Če predpisani odmerek ni učinkovit, bolnik pa ga dobro prenaša, ga lahko zdravnik poveča.
Ethyl parahydroxybenzoate (E214) Sodium methyl parahydroxybenzoate (E219) Citric acid monohydrate
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi makrogol 400 glicerol aroma pomaranče sukraloza etilparahidroksibenzoat (E214) natrijev metilparahidroksibenzoat (E219) citronska kislina monohidrat trinatrijev citrat prečiščena voda
In the event of (prior) treatment with medicinal products that can have adverse reactions on bone marrow (e.g. sulphonamides, trimethoprim/sulphamethoxazole, chloramphenicol, pyrimethamine), the possibility of haematopoietic disorders must be considered.
(npr. sulfonamidi, trimetoprim/sulfametoksazol, kloramfenikol, pirimetamin), je treba upoštevati možnost hematopoetskih motenj.
Thromboembolic reactions (including arterial and cerebral thrombosis, thrombophlebitis, deep leg vein thrombosis, retinal vein thrombosis, pulmonary embolism), Hypotension
(vključno z arterijsko in možgansko trombozo, tromboflebitisom , globoko vensko trombozo, vensko trombozo mrežnice,
Radiation-induced dermatitis and sunburn can reappear during methotrexate therapy (recall reactions).
Med zdravljenjem z metotreksatom se lahko znova pojavijo dermatitis, ki ga povzroči obsevanje, in sončne opekline (spominske reakcije).
• Patient Card
• opozorilno kartico za bolnika.
The other ingredients are: macrogol 400, glycerol, orange flavour, sucralose, ethyl parahydroxybenzoate (E214), sodium methyl parahydroxybenzoate (E219), citric acid, tri-sodium citrate, purified water.
etilparahidroksibenzoat (E214), natrijev metilparahidroksibenzoat (E219), citronska kislina, trinatrijev citrat, prečiščena voda.
Concurrent vaccination using live vaccines should not be given.
Cepljenja z živimi cepivi se med zdravljenjem z metotreksatom ne sme izvajati.
Telangiectasis, Hidradenitis
akutna zanohtnica, furunkuloza teleangiektazija hidradenitis
Your doctor will therefore do tests to check for any changes in your blood (such as a low white blood cell count, a low blood platelet count, lymphomas), kidneys or liver.
Zato bo zdravnik opravil preiskave, s katerimi bo preveril morebitne spremembe v krvi (npr. nizko število belih krvnih celic,
Most frequently (very common) observed adverse reactions of methotrexate include gastrointestinal disorders (e.g. stomatitis, dyspepsia, abdominal pain, nausea, loss of appetite) and abnormal liver function tests (e.g. increased alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), bilirubin, alkaline phosphatase).
Najpogostejši (zelo pogosti) opaženi neželeni učinki metotreksata vključujejo bolezni prebavil (npr. stomatitis, dispepsijo, bolečine v trebuhu, navzejo, izgubo teka) in nenormalne teste jetrne funkcije
Eosinophilia, Neutropenia, Lymphadenopathy
limfoproliferativna bolezen2, eozinofilija, nevtropenija, limfadenopatija krvavitve
− mood swings
− nihanja razpoloženja,
- if you have a weakened immune system - if you are suffering from a serious infection such as tuberculosis or HIV - if you have ulcers in the stomach or in the intestines - if you have an inflammation of the mucous membrane of the mouth or mouth ulcers - if you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”) - if you have had a live vaccine recently or are about to have one
− ste noseči ali dojite (glejte poglavje „Nosečnost, dojenje in plodnost“); − ste bili pred kratkim cepljeni ali če boste cepljeni z živim cepivom.
Pain,
− driska,
Such side effects cannot be excluded when methotrexate is used to treat other diseases.
Če se metotreksat uporablja za zdravljenje drugih bolezni, takšnih neželenih učinkov ni mogoče izključiti.
Due to its potentially toxic effects on the liver, additional hepatotoxic medicinal products should not be taken during treatment with methotrexate unless urgently necessary and the consumption of alcohol should be avoided or reduced (see section 4.5).
- Zaradi morebitnega toksičnega učinka na jetra se med zdravljenjem z metotreksatom ne smejo uporabljati dodatna hepatotoksična zdravila, razen če je to nujno potrebno.
The use of nitrous oxide potentiates the effect of methotrexate on folate metabolism, yielding increased toxicity such as severe, unpredictable myelosuppression, stomatitis and neurotoxicity with intrathecal administration.
kar povzroči povečano toksičnost, ki se lahko izrazi v obliki hude, nepredvidljive mielosupresije, stomatitisa in nevrotoksičnosti.
Jylamvo contains ethyl parahydroxybenzoate and sodium methyl parahydroxybenzoate
Zdravilo Jylamvo vsebuje etilparahidroksibenzoat in natrijev metilparahidroksibenzoat
The dose should be adjusted as follows for patients with rheumatoid arthritis, juvenile arthritis, psoriasis and psoriatic arthritis.
Pri bolnikih z revmatoidnim artritisom, juvenilnim artritisom, psoriazo in psoriatičnim artritisom je treba odmerek prilagoditi.
Insufficient data is available for methotrexate exposure during pregnancy higher than 30 mg (15 ml)/week, but higher rates of spontaneous abortions and congenital malformations are expected, in particular at doses commonly used in oncologic indications
vendar se pričakujejo višje stopnje spontanih splavov in kongenitalnih malformacij, še zlasti pri odmerkih, ki se pogosto uporabljajo pri onkoloških indikacijah.
− kidney disease, inflammation or ulcers of the bladder (possibly also with blood in the urine),
− bolezen ledvic, vnetje ali razjede sečnega mehurja (lahko se pojavi kri v urinu), boleče uriniranje, − vnetje in draženje v nožnici.
Psoriatic lesions can worsen during UV radiation and co-administration of methotrexate.
psoriatične lezije se lahko s sočasnim obsevanjem z UV-žarki poslabšajo, dermatitis,
− nausea, vomiting, abdominal discomfort or severe diarrhoea
− navzeja, bruhanje, neprijeten občutek v trebuhu ali huda driska,
− inflammation of the lungs (pneumonia) with dry cough, shortness of breath and fever
− vnetje pljuč (pljučnica) s suhim kašljem, zadihanostjo in zvišano telesno temperaturo,
How to store Jylamvo
Shranjevanje zdravila Jylamvo
Take Jylamvo only once a week for the treatment of rheumatic or skin diseases (RA, JIA and psoriasis or psoriatic arthritis).
Zdravilo Jylamvo jemljite samo enkrat na teden pri zdravljenju revmatskih ali kožnih bolezni (RA,
Malignant lymphomas may occur in patients receiving low dose methotrexate, in which case therapy must be discontinued.
Pri bolnikih, ki jemljejo majhne odmerke metotreksata, se lahko pojavijo maligni limfomi.
Methotrexate should be administered only with the greatest caution, if at all, in patients with significant existing or previous liver disease, especially if due to alcohol.
Pri bolnikih s hudim trenutnim ali nedavnim obolenjem jeter, zlasti če je ta posledica alkohola, je treba metotreksat, če sploh, uporabljati zelo previdno.
Methotrexate should be used only with great caution, if at all, in patients who have a significant liver disease, particularly if this is/was alcohol-related.
Pri bolnikih s hudo boleznijo jeter, zlasti če je ta posledica alkohola, je treba metotreksat, če sploh,
Patients with rheumatological or dermatological diseases must be informed unequivocally that treatment is to be taken just once a week and not daily.
Revmatološke ali dermatološke bolniki je treba jasno opozoriti na to, da se zdravilo uporablja samo enkrat tedensko in ne vsak dan. Nepravilna uporaba metotreksata lahko povzroči hude neželene učinke, ki so lahko celo smrtni.
You should avoid fathering a child or to donate semen during treatment with methotrexate and for at least 6 months after the end of treatment.
Med zdravljenjem z metotreksatom in še vsaj šest mesecev po koncu zdravljenja se morate izogibati spočetju otroka ali darovanju semenske tekočine.
Closer monitoring of liver enzymes should be undertaken in patients taking other hepatotoxic medicinal products concomitantly (e.g. leflunomide).
Pri bolnikih, ki sočasno prejemajo druga hepatotoksična zdravila (npr. leflunomid), je treba skrbno spremljati jetrne encime.
− fingernail infections, detachment of the nail from the nail bed, boils, widening of small blood vessels, damage to the blood vessels of the skin, allergic inflammation of blood vessels
− vnetje nohtov, odstopanje nohtov od nohtne posteljice, bule, razširitev malih krvnih žil,
Put on disposable gloves before handling.
Konico brizge za odmerjanje potisnite v odprtino nastavka.
− a blood disorder characterised by the appearance of very large red blood cells (megaloblastic anaemia)
Redki (pojavijo se lahko pri največ 1 od 1 000 bolnikov): − krvna motnja, za katero je značilen pojav zelo velikih rdečih krvničk (megaloblastna anemija),
The risk of an interaction between NSAIDs and methotrexate should be considered in patients with a low methotrexate dose, particularly in the case of impaired kidney function.
Pri bolnikih, zdravljenih z majhnimi odmerki metotreksata, še posebno pri tistih z okvarjenim delovanjem ledvic, je treba upoštevati medsebojno delovanje nesteroidnih protivnetnih zdravil in metotreksata.
In addition, pulmonary alveolar haemorrhage has been reported with methotrexate used in rheumatologic and related indications.
3 O tem so poročali pri uporabi metotreksata pri revmatoloških in sorodnih indikacijah.
Immunosuppression, Allergic vasculitis (severe toxic symptom), Hypogammaglobulinaemia
anafilaktični šok, zvišana telesna temperatura, mrzlica imunosupresija, alergijski vaskulitis (hud simptom toksičnosti),
Allergic reactions, Anaphylactic shock,
Bolezni imunskega sistema alergijske reakcije,
Renal failure, Oliguria, Anuria, Azotaemia
(po možnosti s hematurijo), disurija ledvična odpoved, oligurija, anurija, azotemija proteinurija
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijski alveolitis/pljučnica
Oral solution.
Peroralna uporaba.
Diarrhoea can be a possible side effect of Jylamvo and requires an interruption of therapy.
Možen neželeni učinek zdravila Jylamvo je driska; če se pojavi, je treba zdravljenje prekiniti.
- diuretics, that reduce fluid retention - medicines for lowering blood sugar levels such as metformin
− zdravila za zniževanje ravni glukoze v krvi, kot je metformin, − retinoide (za zdravljenje luskavice in drugih bolezni kože),
Symptoms include leucocytopenia, thrombocytopenia, anaemia, pancytopenia, neutropenia, myelosuppression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration and bleeding.
Simptomi vključujejo levkopenijo, trombocitopenijo, anemijo, pancitopenijo, nevtropenijo,
Treatment should not be initiated or should be discontinued if there are any abnormalities in liver function tests or liver biopsies, or if these develop during therapy.
Če se med preiskavami delovanja jeter ali biopsijami jeter odkrijejo kakršne koli bolezenske spremembe ali če te nastanejo med zdravljenjem, se zdravljenje ne sme začeti oziroma ga je treba prekiniti.
The possibility of delayed methotrexate clearance should be considered in combination with other cytostatic medicinal products.
Pri sočasni uporabi metotreksata z drugimi citostatičnimi zdravili je treba upoštevati, da je lahko očistek metotreksata zakasnel.
This oral solution contains 2 mg methotrexate in 1 ml solution and the scaling of the dosing syringe is in ml and not mg.
Opozorila in previdnostni ukrepi Pomembno opozorilo glede odmerjanja zdravila Jylamvo (metotreksat): Ta peroralna raztopina vsebuje 2 mg metotreksata v 1 ml raztopine, merilne enote na brizgi za odmerjanje pa so mililitri in ne miligrami.
Cerebral oedema, Acute aseptic meningitis with meningism (paralysis, vomiting), Lethargy,
akutni aseptični meningitis z meningizmom (paralizo, bruhanjem), letargija, prehodna blaga kognitivna motnja, psihoze, afazija,
Infections
ZDRAVILA
− loss of sex drive, erection problems, vaginal discharge, infertility, enlargement of the breasts in men (gynaecomastia) − fever.
− izguba libida, težave z erekcijo, nožnični izcedek, neplodnost, povečanje prsi pri moških
Recommended dose
− Navodilo shranite.
− lymphoma (lump in neck, groin or armpits with associated backache, weight loss or night sweats)
− limfom (oteklina na vratu, v dimljah ali pod pazduhama, ki ji je pridružena bolečina v hrbtu,
Your doctor must carry out investigations and laboratory tests in order to detect these effects as early as possible.
Za njihovo pravočasno prepoznavanje bo vaš zdravnik opravil preiskave in laboratorijske teste.
The prescriber should make sure patients understand that Jylamvo (methotrexate) should only be taken once a week.
Zdravnik, ki predpisuje zdravilo, se mora prepričati, da bolniki razumejo, da smejo zdravilo Jylamvo
Dosage in adult rheumatoid arthritis: The usual initial dose is 7.5 mg (3.75 ml), once a week.
Običajni začetni odmerek je 7,5 mg (3,75 ml) enkrat tedensko.
Symptoms of overdose are e.g. sore throat, fever, mouth ulcers, diarrhoea, vomiting, skin rashes, bleeding or unusual weakness.
Simptomi prevelikega odmerjanja so npr. vnetje žrela, zvišana telesna temperatura, razjede v ustih, driska,
Diabetes mellitus
Kreatininski očistek
See also section “Pregnancy, breast-feeding and fertility”.
Glejte tudi poglavje „Nosečnost,
Oral solution 60 ml bottle Bottle adaptor 10 ml dosing syringe
Steklenička 60 ml Nastavek za stekleničko
especially bone marrow depression.
zlasti z zaviranjem delovanja kostnega mozga.
Loss of appetite, Nausea, Vomiting, Abdominal pain,
Bolezni prebavil izguba teka, navzeja, bruhanje,
Excipient warnings
peroralna raztopina
Methotrexate-induced haematopoietic suppression may occur abruptly and with apparently safe dosages.
Nenadoma in pri na videz varnih odmerkih metotreksata lahko pride do z metotreksatom povzročene zavore hematopoeze.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Pulmonary fibrosis
Žilne bolezni tromboembolične reakcije
• Information on treatment with Jylamvo, administration and posology.
• informacije glede zdravljenja z zdravilom Jylamvo, uporabe in odmerjanja
− blood test showing raised liver enzymes.
vnetje in razjede v ustih in žrelu, − izvidi preiskav krvi, ki kažejo zvišane vrednosti jetrnih encimov.
− diabetes
− sladkorna bolezen,
− inflammation of the pancreas, inflammation of the digestive tract, bloody stools, inflamed gums,
− vnetje trebušne slinavke, vnetje prebavil, krvavo blato, vnetje dlesni, prebavne motnje,
− loss of appetite, feeling sick (nausea), vomiting, abdominal pain, indigestion, inflammation and ulcers of the mouth and throat
− izguba teka, slabost (siljenje na bruhanje), bruhanje, bolečine v trebuhu, prebavne motnje,
Methotrexate has moderate influence on the ability to drive and use machines, since central nervous system disorders such as tiredness, dizzy spells or drowsiness can occur during treatment.
Med zdravljenjem z zdravilom Jylamvo se lahko pojavijo neželeni učinki, ki vplivajo na osrednje živčevje, npr. utrujenost in omotica.
You must talk to a doctor if you do not feel better or if you feel worse
Če se znaki vaše bolezni poslabšajo ali ne izboljšajo, se posvetujte z zdravnikom.
Male Fertility
Plodnost pri moških
It is particularly important to tell your doctor if you are using the following medicines: - other medicines for rheumatoid arthritis or psoriasis, such as leflunomide, azathioprine (also used to prevent rejection after an organ transplant), sulfasalazine (also used for ulcerative colitis) - ciclosporin (for supressing the immune system) - non-steroidal anti-inflammatory drugs or salicylates (medicines against pain and/or inflammation such as acetylsalicylic acid, diclofenac and ibuprofen or pyrazole) - live vaccines
− nesteroidna protivnetna zdravila ali salicilate (protibolečinska in/ali protivnetna zdravila, kot so acetilsalicilna kislina, diklofenak in ibuprofen ali pirazol), − živa cepiva,
• Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcers
• stomatitis, razjede v ustni votlini in znane aktivne ulkusne bolezni prebavil; • dojenje (glejte poglavje 4.6);
Elderly
Bata
Elimination in patients with impaired renal function is markedly delayed.
Pri okvari ledvic se izločanje znatno podaljša.
Before the beginning of treatment
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Osteonecrosis of jaw (secondary to lymphoprolifer -ative disorders)
Bolezni mišično skeletnega sistema in vezivnega tkiva osteoporoza artralgija mialgija stresni zlom osteonekroza čeljusti (kot posledica limfoprolifer -ativnih bolezni)
− severe visual disorders
− učinkuje protivnetno.
Enlarged lymph nodes (lymphoma) may occur in patients receiving low dose methotrexate and if this is the case, therapy must be stopped.
Pri bolnikih, ki prejemajo majhne odmerke metotreksata, se lahko pojavijo otekle bezgavke (limfom);
Vitamin preparations or other products containing folic acid, folinic acid or their derivatives may decrease the effectiveness of methotrexate (see sections 4.2 and 4.5).
Vitaminski pripravki ali drugi izdelki, ki vsebujejo folno kislino, folinsko kislino ali njune derivate,
− pain or difficulties in passing urine
Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura
The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Accord on 21 March 2012.
Evropska komisija je dovoljenje za promet z zdravilom Pioglitazone Accord, veljavno po vsej Evropski uniji, izdala 21. marca 2012.
Treatment with Pioglitazone Accord should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Zdravljenje z zdravilom Pioglitazone Accord je treba ponovno oceniti po treh do šest mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, prekiniti.
The full EPAR for Pioglitazone Accord 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 Pioglitazone Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Posledično se raven glukoze v krvi zniža, kar pripomore k boljšemu uravnavanju sladkorne bolezni tipa 2.
Pioglitazone Accord is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Zdravilo Pioglitazone Accord se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih (starejših od 18 let), zlasti tistih s prekomerno telesno maso.
This is a summary of the European public assessment report (EPAR) for Pioglitazone Accord.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pioglitazone Accord.
What measures are being taken to ensure the safe and effective use of Pioglitazone Accord?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pioglitazone Accord?
The company that markets Pioglitazone Accord will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Družba, ki trži zdravilo Pioglitazone Accord, bo za zdravnike, ki bodo predpisovali zdravilo, pripravila izobraževalno gradivo, ki bo vključevalo možno tveganje za srčno popuščanje in rak sečnega mehurja pri zdravljenju s pioglitazonom, merila za izbiro bolnikov in potrebo po redni oceni zdravljenja ter njegovi prekinitvi, če to bolnikom ne koristi več.
This means that Pioglitazone Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Actos.
The active substance in Pioglitazone Accord, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Zdravilna učinkovina v zdravilu Pioglitazone Accord, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pioglitazone Accord has been shown to have comparable quality and to be bioequivalent to Actos.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pioglitazone Accord primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
The Committee recommended that Pioglitazone Accord be approved for use in the EU.
Priporočil je, da se zdravilo Pioglitazone Accord odobri za uporabo v EU.
The medicine is available as tablets (15, 30 and 45 mg) and the recommended starting dose is 15 or 30 mg once a day.
Zdravilo je na voljo v obliki tablet (15, 30 in 45 mg), priporočeni začetni odmerek pa je 15 ali 30 mg enkrat na dan. Odmerek bo po enem ali dveh tednih morda treba povečati do 45 mg enkrat na dan, če je treba izboljšati uravnavanje glukoze (sladkorja) v krvi.
Because Pioglitazone Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Pioglitazone Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
For more information about treatment with Pioglitazone Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pioglitazone Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is Pioglitazone Accord and what is it used for?
Kaj je zdravilo Pioglitazone Accord in za kaj se uporablja?
What are the benefits and risks of Pioglitazone Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Pioglitazone Accord?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pioglitazone Accord have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pioglitazone Accord upoštevati zdravstveni delavci in bolniki, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Pioglitazone Accord is a ‘generic medicine'.
Zdravilo Pioglitazone Accord je „generično zdravilo“.
Other information about Pioglitazone Accord
Druge informacije o zdravilu Pioglitazone Accord
Because Pioglitazone Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Ker je zdravilo Pioglitazone Accord generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Actos.