FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to launch of Jylamvo in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Jylamvo f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jiftiehem mal-Awtorità Nazzjonali Kompetenti dwar il-kontenut u l-format tal-materjal edukattiv, inkluż il-mezzi tal-komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Maltese: Neoplażmi beninni, malinn-i u dawk mhux speċifikati (inklużi ċesti u polipi)
English: Nephropathy Inflammation and ulceration of urinary bladder (possibly with haematuria), Dysuria
Maltese: Nefropatija Infjammazzjoni u ulċerazzjoni tal-bużżieqa tal awrina (possibilment blematurja),
English: If clinically indicated, tuberculosis and hepatitis B and C should be excluded.
Maltese: it-tuberkulożi u l-epatite B u Ċ għandhom jiġu esklużi.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu)
English: In particular, elderly patients should be monitored at short intervals for early signs of toxicity (see section 4.2).
Maltese: B'mod partikolari, il-pazjenti anzjani għandhom jiġu mmonitorjati f'intervalli qosra għal sinjali bikrija ta' tossiċità (ara s sezzjoni 4.2).
English: Treatment should follow currently published therapy protocols for children (see section 4.4).
Maltese: Il-kura għandha ssegwi protokolli tatterapija attwalment ippubblikati għat-tfal (ara s-sezzjoni 4.4).
English: The half-life may be prolonged up to four-fold in patients with a third distribution compartment (pleural effusion, ascites).
Maltese: In-nofs ħajja tista' tittawwal sa erba' darbiet f'pazjenti bit-tielet kompartiment ta' distribuzzjoni (effużjoni plewrali, axxite).
English: − thirst and/or frequent urination
Maltese: − għatx u/jew awrina frekwenti
English: The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes methotrexate less than 30 mg (15 ml)/week.
Maltese: L-evidenza disponibbli ma tindikax riskju ogħla ta' malformazzjonijiet jew korrimenti fit-tqala jekk il missier jieħu inqas minn 30 mg (15 ml)/ġimgħa ta' methotrexate.
English: Infertility, Loss of libido, Impotence, Vaginal discharge, Gynaecomastia
Maltese: Telf tal-libido, Impotenza, Tnixxija mill-vaġina,
English: − diarrhoea
Maltese: − dijarea
English: One ml of solution contains 2 mg methyl hydroxybenzoate (as the sodium salt), and 0.2 mg ethyl hydroxybenzoate.
Maltese: 0.2 mg ta' ethyl hydroxybenzoate.
English: Methotrexate has been reported to cause impairment of fertility, oligospermia, menstrual dysfunction and amenorrhoea in humans during and for a short period after the discontinuation of treatment, affecting spermatogenesis and oogenesis during the period of its administration - effects that appear to be reversible on discontinuing therapy.
Maltese: Methotrexate ġie rrappurtat li jikkawża indeboliment tal-fertilità, oligospermja, disfunzjoni menstruwali u amenorrea fil-bniedem matul u għal perjodu qasir wara l-waqfien tal-kura, li jaffettwa l ispermatoġenesi u l-ooġenesi waqt il-perijodu tal-amministrazzjoni tiegħu - effetti li jidhru riversibbli meta t-terapija tittwaqqaf.
English: Methotrexate has been shown to be teratogenic to humans; it has been reported to cause foetal death, miscarriages and/or congenital abnormalities (e.g. craniofacial, cardiovascular, central nervous system and extremity-related).
Maltese: Methotrexate wera li huwa teratoġeniku għall-bnedmin; ġie rrappurtat li jikkawża mewt tal-fetu, korrimenti u/jew anormalitajiet konġenitali (eż. kranjofaċċali, kardjovaskulari, sistema nervuża ċentrali, u dawk relatati mal-estremitajiet).
English: You will possibly also have an X-ray of your chest.
Maltese: Inti possibbilment se tieħu wkoll raġġi-X ta' sidrek.
English: Pruritus vasculitis, herpetiform skin eruptions, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), Increased rheumatic nodules,
Maltese: , nekroliżi tossika epidermali (sindromu ta' Lyell), Noduli rewmatiċi miżjuda, Erożojonijiet bluġigħ tal-plakka bil-psorijażi,
English: Treatment should follow current therapy protocols.
Maltese: Il-kura għandha ssegwi protokolli ta' terapija attwali.
English: Antibiotics such as penicillins, glycopeptides, sulphonamides, ciprofloxacin and cefalotin can in individual cases reduce the renal clearance of methotrexate, so that increased serum methotrexate concentrations can occur, accompanied by haematological and gastrointestinal toxicity.
Maltese: L-antibijotiċi bħal peniċillini, glikopeptidi, sulfonamidi, ciprofloxacin u cefalotin jistgħu f'każijiet individwali jnaqqsu t-tneħħija mill-kliewi ta' methotrexate, sabiex il-konċentrazzjonijiet ta'
English: Therefore, the possible effects on reproduction, pregnancy loss and congenital malformations should be discussed with female patients of childbearing age (see section 4.6).
Maltese: Għalhekk, leffetti possibbli fuq ir-riproduzzjoni, telf ta' tqala u malformazzjonijiet konġenitali għandhom jiġu diskussi ma' pazjenti femminli ta' età li jista' jkollhom it-tfal (ara sezzjoni 4.6).
English: Pneumocystis jiroveci pneumonia and other lung infections, Chronic obstructive pulmonary disease, Pleural effusion
Maltese: Marda pulmonari ostruttiva kronika,
English: Other medicines and Jylamvo
Maltese: Mediċini oħra u Jylamvo
English: Dosage in adult patients with rheumatoid arthritis
Maltese: Dożaġġ f'pazjenti adulti b'artrite rewmatika
English: 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.
Maltese: L-użu ta' nitrous oxide jqawwi l-effett ta' methotrexate fuq il-metaboliżmu ta' folates, b'rendiment ogħla ta' tossiċità bħal mijelosuppressjoni mhux prevedibbli, stomatitè u newrotossiċità b'għoti intratekali.
English: Dermatitis and sunburn
Maltese: Tibdil fil-burdata Insomnija
English: Please note that this oral solution contains 2 mg methotrexate in 1 ml solution and that the scaling of the dosing syringe is in ml and not mg.
Maltese: Jekk jogħġbok innota li din is-soluzzjoni orali fiha 2 mg ta' methotrexate f'soluzzjoni ta' 1 ml u liskalar tas-siringa tad-dożaġġ huwa f'ml u mhux f'mg.
English: − mood swings
Maltese: Effużjoni plewrali
English: − severe visual disorders
Maltese: − kontraċettivi orali
English: Jylamvo is used in patients with: - the following rheumatic and skin diseases: o active rheumatoid arthritis (RA) in adults o polyarthritic forms (when five or more joints are affected) of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate o severe, treatment-resistant, disabling psoriasis that does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, as well as in severe psoriasis that also affects the joints (psoriatic arthritis) in adult patients - acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over
Maltese: 3 snin u iżjed meta r-rispons għal mediċini antiinfjammatorji mhux sterojdi (nonsteroidal anti-inflammatory drugs, NSAIDs) ma jkunx adegwat o psorjasi severa, reżistenti għall-kura u diżabilitanti li ma tirrispondix b'mod xieraq għal forom oħra ta' kura bħal fototerapija, terapija ta' radjazzjoni ta' psoralen u ultravjola A
English: This oral solution contains 2 mg methotrexate in 1 ml solution and the scaling of the dosing syringe is in ml and not mg.
Maltese: Din is-soluzzjoni orali fiha 2 mg ta' methotrexate f'soluzzjoni ta' 1 ml u l-iskalar tas-siringa tad-dożaġġ huwa f'ml u mhux f'mg.
English: Orange flavour
Maltese: Użu orali
English: tissue disorders
Maltese: Id-doża rakkomandata
English: Methotrexate should be discontinued in patients with pulmonary symptoms and an immediate examination (including chest X-ray) should be performed to exclude infection and tumours.
Maltese: Methotrexate għandu jitwaqqaf f'pazjenti b'sintomi pulmonari u għandu jitwettaq eżami immedjat (inkluż raġġi X tas-sider) biex jiġu esklużi l-infezzjoni u t-tumuri.
English: Glycerol
Maltese: Anzjani
English: It is recommended to check levels of vitamin B12 prior to initiating folic acid supplementation, particularly in adults aged over 50 years, as folic acid intake may mask a vitamin B12 deficiency.
Maltese: B12 qabel ma tinbeda s-supplimentazzjoni tal-aċidu foliku, b'mod partikolari f'adulti li għandhom aktar minn 50 sena, peress li t-teħid tal-aċidu foliku jista' jaħbi defiċjenza ta' vitamina
English: The application of procarbazine during high-dose methotrexate therapy increases the risk of impairment or renal function
Maltese: L-applikazzjoni ta' procarbazine waqt it-terapija b'methotrexate b'doża għolja żżid ir-riskju ta' indeboliment tal-funzjoni tal-kliewi.
English: 2 Lymphoma/Lymphoproliferative disorders: there have been reports of individual cases of lymphoma and other lymphoproliferative disorders which subsided in a number of cases once treatment with methotrexate had been discontinued.
Maltese: 2 Limfoma/Disturbi limfoproliferattivi: kien hemm rapporti ta' każijiet individwali ta' limfoma u disturbi limfoproliferattivi oħrajn li battew f'għadd ta' każijiet ġaladarba it-trattament b'methotrexate twaqqaf.
English: In the antineoplastic treatment, myelosuppression and mucositis are the predominant dose-limiting toxic effects of methotrexate.
Maltese: Fil-kura antineoplastika, il-majelosuppressjoni u l-mukożite huma l-effetti tossiċi li jillimtaw id-doża predominanti ta' methotrexate.
English: Diarrhoea and ulcerative stomatitis may be signs of toxic effects and require the discontinuation of treatment, otherwise haemorrhagic enteritis and death from intestinal perforation may occur.
Maltese: Id-dijarea u l-istomatite ulċerattiva jistgħu jkunu sinjali ta' effetti tossiċi u jeħtieġu t-twaqqif tal-kura, inkella jistgħu jseħħu enterite emorraġika u mewt minn perforazzjoni intestinali.
English: Diabetes mellitus
Maltese: Dijabete mellitus
English: Methotrexate-induced lung diseases such as pneumonitis can occur acutely and at any time during treatment, are not always completely reversible and have already been observed at all doses (including low doses of 7.5 mg (3.75 ml)/week).
Maltese: Mard tal pulmun ikkawżat minn methotrexate bħall-pulmonite jista' jseħħ b'mod akut u fi kwalunkwe ħin matul il-kura, mhuwiex dejjem kompletament riversibbli u diġà ġie osservat fid-dożi kollha (inklużi dożi baxxi ta' 7.5 mg (3.75 ml)/ġimgħa).
English: Diarrhoea
Maltese: Anemija
English: Bone marrow depression (severe courses),
Maltese: Depressjoni talmudullun dipressjoni (korsijiet severi)
English: Particular caution is also required in the presence of inactive chronic infections (e.g. herpes zoster, tuberculosis, hepatitis B or C) as it is possible that activation of these infections may occur.
Maltese: Hija meħtieġa wkoll attenzjoni partikolari fil-preżenza ta' infezzjonijiet kroniċi inattivi (eż. herpes zoster, tuberkulożi, epatite B jew Ċ) peress li huwa possibbli li sseħħ l-attivazzjoni ta'
English: Excretion occurs predominantly in the unchanged form by glomerular filtration and active secretion in the proximal tubule via the kidneys.
Maltese: L-eskrezzjoni sseħħ b'mod predominanti fil-forma mhux mibdula mill-filtrazzjoni glomerulari u ssekrezzjoni attiva fit-tubulu prossimali permezz tal-kliewi.
English: − inflammation of the pancreas, inflammation of the digestive tract, bloody stools, inflamed gums,
Maltese: − moviment indebolit tal-muskoli użati għall-produzzjoni tad-diskors, diffikultà biex titkellem,
English: Very rare (may affect up to 1 in 10,000 people):
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000):
English: Dose in rheumatic and skin diseases (RA, JIA and psoriasis or psoriatic arthritis)
Maltese: Id-doża f'mard rewmatiku u tal-ġilda (RA, JIA u psorjasi jew artrite psorjatika) Ħu Jylamvo darba fil-ġimgħa biss.
English: Pericarditis, Pericardial effusion, Pericardial tamponade
Maltese: − dardir, rimettar, skumdità addominali jew dijarea severa
English: Persistent abnormalities of liver enzymes and/or a decrease in serum albumin can indicate severe hepatotoxicity.
Maltese: Anormalitajiet persistenti ta' enżimi talfwied u/jew tnaqqis fl-albumina tas-seru jistgħu jindikaw epatotossiċità severa.
English: Thromboembolic reactions (including arterial and cerebral thrombosis, thrombophlebitis, deep leg vein thrombosis, retinal vein thrombosis, pulmonary embolism), Hypotension
Maltese: Reazzjonijiet tromboemboliċi (inkluż trombożi arterjali u ċerebrali,
English: Acute liver degeneration, Liver failure, Reactivation of chronic hepatitis,
Maltese: Indeboliment tal-fwied, Riattivazzjoni talepatite kronika
English: The possibility of delayed methotrexate clearance should be considered in combination with other cytostatic medicinal products.
Maltese: Il-possibbiltà ta' tneħħija ta' methotrexate mdewma għandha titqies f'kombinazzjoni ma' prodotti mediċinali ċitostatiċi oħra.
English: Pancytopenia, Agranulocytosis, Haematopoietic disorders
Maltese: Pankreatite, Enterite, Assorbiment ħażin,
English: 3 has been reported for methotrexate used in rheumatologic and related indications 4 see remarks on liver biopsy in section 4.4
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: In patients with rheumatoid arthritis or psoriasis, folic acid or folinic acid supplementation may reduce methotrexate toxicity, such as gastrointestinal symptoms, stomatitis, alopecia and elevated liver enzymes.
Maltese: F'pazjenti b'artrite tar-rewmatojde jew psorjasi, is-supplimentazzjoni tal-aċidu foliku jew tal-aċidu foliniku tista' tnaqqas it-tossiċità ta' methotrexate, bħal sintomi gastrointestinali, stomatite, alopeċja u enzimi tal-fwied elevati.
English: − serious disorder of bone marrow (anaemia), swollen glands
Maltese: − disturb serju tal-mudullun (anemija), glandoli minfuħin
English: Methotrexate has been shown to be genotoxic in animal studies, such that the risk of genotoxic effects on sperm cells cannot completely be excluded.
Maltese: Methotrexate ntwera li hu ġenotossiku fi studji fuq l-annimali, b'mod li r-riskju ta' effetti ġenotossiċi ma jistax jiġi eskluż kompletament.
English: − joint or muscle pain, osteoporosis (reduction in bone strength)
Maltese: − uġigħ fil-ġogi jew fil-muskoli, osteoporożi (tnaqqis fis-saħħa tal-għadam)
English: Hepatic steatosis, fibrosis and cirrhosis, Decrease in serum albumin
Maltese: Steatożi, fibrożi u ċirrożi tal fwied,
English: Toxic megacolon, Haematemesis
Maltese: Megakolon tossiku,
English: How to take Jylamvo
Maltese: X'fih Jylamvo
English: Chills
Maltese: Ngħas
English: Photosensitivity, Increased skin pigmentation, Hair loss, Impaired wound healing,
Maltese: Fotosenittività, Pigmentazzjoni tal-ġilda miżjuda, Telf ta' xagħar,
English: Talk to your doctor or pharmacist before taking Jylamvo: - if you have diabetes mellitus treated with insulin - if you are suffering from inactive, chronic infections (e.g. tuberculosis, hepatitis B or C,
Maltese: − jekk qed tbati minn infezzjonijiet inattivi u kroniċi (eż. tuberkulożi, epatite B jew Ċ, ħruq ta'
English: Radiation-induced dermatitis and sunburn can reappear during methotrexate therapy (recall reactions).
Maltese: Id-dermatite indotta mir-radjazzjoni u l-ħruq mix-xemx jistgħu jerġgħu jitfaċċaw matul it-terapija b'methotrexate (reazzjonijiet “recall”).
English: Dosage in children and adolescents with polyarthritic forms of juvenile idiopathic arthritis
Maltese: Id-dożaġġ fit-tfal u fl-adolexxenti b'forom ta' poliartrite ta' artritè idjopatika ġovanili (juvenile idiopathic arthritis, JIA).
English: Additionally for non-oncological indications • Pregnancy (see section 4.6)
Maltese: il-kura hija kontraindikata waqt il-perjodu tat-treddigħ (ara s-sezzjoni 4.3).
English: The combination of methotrexate and sulfasalazine can enhance the effect of methotrexate, as sulfasalazine causes inhibition of folic acid synthesis.
Maltese: Mhux magħruf jekk methotrexate hux preżenti fis-semen.
English: This evaluation should differentiate between patients with no risk factors and patients with risk factors, such as excessive prior alcohol consumption, persistent elevation of liver enzymes, history of liver disease, family history of a hereditary liver disease, diabetes mellitus, obesity and history of significant exposure to hepatotoxic medicinal product or chemicals, as well as prolonged methotrexate treatment or a cumulative total dose of 1.5 g or more.
Maltese: evalwazzjoni persistenti ta' enzimi tal-fwied, storja ta' mard tal-fwied, storja familjari ta' mard tal-fwied ereditarju, dijabete milletus, obeżità u storja ta' esponiment sinifikanti għal prodott mediċinali jew kimiċi epatotossiċi, kif ukoll kura b'methotrexate fit-tul jew doża totali kumulattiva ta' 1.5 g jew iżjed.
English: Cardiac disorders
Maltese: Nocardiosis,
English: Immunosuppression, Allergic vasculitis (severe toxic symptom), Hypogammaglobulinaemia
Maltese: Anemija alpastika, Disturb limfoproliferattiv2, Eosinofilija, Newtropenija, Limfadenopatija
English: − tonsillitis, stopping breathing, asthma
Maltese: − tonsillite, waqfien tan-nifs, ażma
English: Probenecid and weak organic acids can also reduce the tubular secretion of methotrexate and thus likewise cause an indirect increase in dose.
Maltese: Probenecid u aċidi organiċi dgħajfin jistgħu wkoll inaqqsu s-sekrezzjoni tubulari ta' methotrexate u b'hekk jikkawżaw ukoll żieda indiretta fid-doża.
English: In patients with unimpaired elimination mechanisms, myelosuppression and mucositis are generally reversible within 14 to 28 days.
Maltese: F'pazjenti b'mekkaniżmi ta' eliminazzjoni mhux mittiefsa, il-majelosuppressjoni u l-mukożite huma ġeneralment riversibbli fi żmien 14 sa 28 jum.
English: 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
Maltese: M'hemmx biżżejjed tagħrif disponibbli għal esponiment b'methotrexate waqt tqala b'doża ogħla minn 30 mg (15 ml)/ġimgħa, imma rati ogħla ta' aborti spontaneji u malformazzjonijiet konġenitali huma mistennija b'mod partikolari f'dożi komuni użati f'indikazzjonijiet onkoloġiċi
English: Leucocytopenia, Thrombocytopenia, Anaemia
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Inflammation and ulceration
Maltese: Infjammazzjoni u ulċerazzjoni vaġinali
English: Folic acid supplementation
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Jylamvo is for use in the following indications:
Maltese: Jylamvo huwa għall-użu fl-indikazzjonijiet li ġejjin:
English: 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.
Maltese: (sindromu ta' Lyell) jew is-sindromu ta' Stevens-Johnson wara doża waħda jew dożi multipli ta' methotrexate.
English: − lymphoma (lump in neck, groin or armpits with associated backache, weight loss or night sweats)
Maltese: − retinojdi (għall-kura ta' psorjasi u mard ieħor tal-ġilda)
English: Male Fertility
Maltese: Fertilità tal-Irġiel
English: This summary was last updated in 11-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 11-2016.
English: The medicine is available as tablets (15, 30 and 45 mg) and the recommended starting dose is 15 or 30 mg once a day.
Maltese: Il-mediċina tiġi bħala pilloli (15, 30 u 45 mg) u d-doża tal-bidu rakkomandata hija 15 jew 30 mg darba kuljum.
English: 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.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Pioglitazone Accord pioglitazone
Maltese: Pioglitazone Accord pijoglitażon
English: Pioglitazone Accord is a ‘generic medicine'.
Maltese: Pioglitazone Accord huwa "mediċina ġenerika".
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Accord on 21 March 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Pioglitazone Accord valida flUnjoni Ewropea kollha fil-21 ta' Marzu 2012.
English: Pioglitazone Accord contains the active substance pioglitazone.
Maltese: Pioglitazone Accord fih is-sustanza attiva l-pijoglitażon.
English: Other information about Pioglitazone Accord
Maltese: Informazzjoni oħra dwar Pioglitazone Accord
English: 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.
Maltese: Il-kumpanija li tqiegħed Pioglitazone Accord fis-suq se tipproduċi materjal edukattiv għat-tobba li jippreskrivu l-mediċina, li se jkopri r-riskju possibbli ta' insuffiċjenza tal-qalb u kanċer fil-bużżieqa talurina bil-kuri li fihom il-pijoglitażon, il-kriterji għall-għażla tal-pazjenti u l-ħtieġa ta' rieżami regolari tal-kura u li l-kura titwaqqaf jekk il-pazjenti ma jibqgħux jibbenefikaw minnha.
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Accord.
Maltese: Dan huwa sommarju tar-rappport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pioglitazone Accord.
English: 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.
Maltese: Is-sustanza attiva f' Pioglitazone Accord, il-pijoglitażon, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi.
English: This means that Pioglitazone Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Dan ifisser li Pioglitazone Accord huwa simili għall"mediċina ta' referenza" diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Actos.
English: 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.
Maltese: Minħabba li Pioglitazone Accord huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: 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.
Maltese: Peress li Pioglitazone Accord huwa mediċina ġenerika, l-istudji f' pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza Actos.
English: 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.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Pioglitazone Accord għandu kwalità komparabbli u huwa bijoekwivalenti għal Actos.