FrancophonIA/ELRC3.0 huggingface dataset:
English: Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH.
Maltese: Insulin glargine hija insulina analoga umana imfassla b'mod li ma tinħallx biżżejjed f'pH newtrali.
English: Fertility Animal studies do not indicate direct harmful effects with respect to fertility.
Maltese: Fertilità Studji fl-annimali ma jurux li hemm xi effetti diretti ħżiena fuq il-fertilità.
English: Effects of insulin glargine (once daily) on diabetic retinopathy were evaluated in an open-label 5-year NPH-controlled study (NPH given bid) in 1024 type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography.
Maltese: L-effetti ta' insulin glargine (darba kuljum) fuq retinopatija tad-dijabete ġew evalwati f'1024 pażjent fi studju ta' ħames snin, fejn kemm l-investigatur kif ukoll il-pazjenti kienu jafu x'mediċini kienu qed jintużaw, b'NPH bħala kontrol (NPH jingħata darbtejn kuljum) u fejn il-progress tar-retinopatija bi tlett gradi jew aktar fuq Studju Dwar Trattament Kmieni ta' Retinopatija tad-Dijabete (ETDRS) kien investigat b'ritratt tal- fundus.
English: HbA1c changes from baseline were similar between treatment groups; however blood glucose values recorded overnight were significantly higher in the insulin glargine/ lispro group than the NPH/regular group, with a mean nadir of 5.4 mM versus 4.1 mM.
Maltese: Tibdiliet fl-HbA1c mil-linja bażi kienu simili għaż-żewġ gruppi ta' kura; madankollu l-valuri tal-glukożju fid-demm meħud mal-lejl kienu ogħla b'mod sinifikanti fil-grupp tal-insulin glargine/lispro milli fil-grupp NPH/regolari bl-inqas livell jilħaq medja ta' 5.4 mM kontra 4.1 mM.
English: A - Take a new sterile disposable needle and peel off the protective seal.
Maltese: A - Ħu labra sterili ġdida li tintrema wara li tintuża, u qaxxar is-siġill protettiv.
English: If this occurs:
Maltese: Attent:
English: Tabulated list of adverse reactions
Maltese: Lista ta' reazzjonijiet avversi f'forma tabulari
English: Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: - all other medicines to treat diabetes, - angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever), - sulfonamide antibiotics.
Maltese: - disopyramide (użat għall-kura ta' ċerti kundizzjonijiet tal-qalb), - fluoxetine (użat għall-kura tad-depressjoni), - fibrates (użati biex ibaxxu l-livelli għoljin tal-lipidi fid-demm), - l-inibituri ta' monoamine oxidase (MAO) (użati għall-kura tad-depressjoni), - pentoxifylline, propoxyphene, salicylates (bħall-acetylsalicylic acid, użata biex ittaffi l-uġigħ u tbaxxi d-deni), - l-antibijotiċi sulfonamidi.
English: The primary aim of demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there was a trend to an increase of hypoglycemic events with insulin glargine [insulin glargine: NPH rate ratio (95% CI) = 1.18 (0.97-1.44)].
Maltese: Proporzjon tar-rata NPH (95% CI) = 1.18 (0.97-1.44)].
English: • Sterile disposable hypodermic needle compatible with this pen
Maltese: • Labra sterili ipodermika li tintrema wara li tintuża, kompatibbli ma' din il-pinna
English: Although Semglee contains the same active substance as insulin glargine 300 units/ml, these medicines are not interchangeable.
Maltese: Għalkemm Semglee fih l-istess sustanza attiva bħal insulin glargine 300 unità/mL, dawn il-mediċini ma jistgħux jinbidlu ma' xulxin.
English: D - Hold the purple injection button down for 10 seconds after the dose window shows “0” to make sure all of the insulin is injected.
Maltese: D - Żomm il-buttuna tal-injezzjoni vjola 'l isfel għal 10 sekondi wara li t-tieqa tad-doża turi “0” biex tiżgura li l-insulina kollha tiġi injettata.
English: In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
Maltese: Fi studju kliniku, is-sintomi ta' l-ipogliċemija jew ir-rispons ormonali kontro-regolatorju kienu simili wara insulin glargin.e intravenuż u insulina umana intravenuża, kemm f'individwi voluntiera b'saħħithom kif ukoll f'pazjenti bid-dijabete tip 1.
English: In general, the safety profile for children and adolescents (≤ 18 years of age) is similar to the safety profile for adults.
Maltese: Ġeneralment, il-profil ta' sigurtà fit-tfal u fl-adolexxenti (≤ 18-il sena) huwa l-istess bħall-profil ta' sigurtà għall-adulti.
English: • General disorders
Maltese: • Disturbi ġenerali
English: Insulin mix-ups
Maltese: .8 Effetti mhux mixtieqa
English: To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with Semglee should reduce their dose by approximately 20%.
Maltese: Sabiex titnaqqas ir-riskju ta' ipogliċemija, pazjenti li qed ibidlu l-iskeda ta' insulina bażali tagħhom minn skeda ta' insulina b'insulin glargine 300 unità/mL darba kuljum għal skeda ta' darba kuljum b'Semglee għandhom inaqqsu d-doża tagħhom b'madwar 20 %.
English: Severe allergic reactions (rare, may affect up to 1 in 1,000 people) - the signs may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Maltese: Reazzjonijiet allerġiċi serji (rari, jistgħu jaffettwaw sa persuna 1 minn kull 1,000) - is-sinjali jistgħu jinkludu reazzjonijiet tal-ġilda fuq skala kbira (raxx u ħakk mal-ġisem kollu), nefħa severa fil-membrana mukuża (anġioedema), qtugħ ta' nifs, tħarħir, taqa' l-pressjoni fid-demm, polz mgħaġġel jew tkun għarqan.
English: If administration by syringe is necessary, a vial should be used (see sections 4.2 and 4.4).
Maltese: Jekk ikun hemm bżonn ta' teħid permezz ta' siringa, għandu jintuża kunjett (ara sezzjonijiet 4.2 u 4.4).
English: Semglee contains insulin glargine, an insulin analogue, and has a prolonged duration of action.
Maltese: Semglee fih insulin glargine, analogu ta' l-insulina li jaħdem għal perijodu twil ta' żmien.
English: Mylan bvba/sprl
Maltese: Suomi/Finland Mylan Finland OY Puh/Tel:
English: The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 diabetic patients was markedly lower than what would be required for a halfmaximal occupation of the IGF-1 receptor and the subsequent activation of the mitogenic-proliferative pathway initiated by the IGF-1 receptor.
Maltese: Il-konċentrazzjoni terapewtika kollha tal-insulina (insulin glargine u l-metaboliti tiegħu) li nstabet f'pazjenti dijabetiċi tat-tip 1 kienet ħafna inqas milli hemm bżonn sabiex tintlaħaq nofs l-okkupazzjoni massima tar- riċettur IGF-1 u l-attivazzjoni sussegwenti tas-sensiela ta' reazzjonijiet mitoġeniċi-proliferattivi kkawżati mir-riċettur IGF-1.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Semglee 100 units/ml solution for injection insulin glargine
Maltese: U MNEJN GĦANDU JINGĦATA Semglee 100 unità/ml soluzzjoni għall-injezzjoni insulin glargine
English: The exposure to M1 increases with the administered dose of Semglee.
Maltese: L- espożizzjoni għal M1 tiżdied meta tingħata d-doża ta' Semglee.
English: Semglee 100 units/ml solution for injection in pre-filled pen insulin glargine
Maltese: Semglee 100 unità/ml soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest insulin glargine
English: • 2 alcohol wipes
Maltese: • 2 tajjariet bl-alkoħol
English: The adverse reaction reports received from post marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (≤ 18 years of age) than in adults.
Maltese: Ir-rapporti dwar effetti avversi li oriġinaw mis-sorveljanza ta' wara t-tqegħid fis-suq jinkludu reazzjonijiet fis-siti ta' l-injezzjonijiet relattivament aktar spissi (uġigħ fis-sit ta' l-injezzjoni, reazzjoni fis-sit ta' l- injezzjoni) u reazzjonijiet tal-ġilda (raxx, urtikarja) fit-tfal u fl-adolexxenti (≤ 18-il sena) meta mqabblin mal- adulti.
English: At the last on-treatment visit, there was a mean increase in body weight from baseline of 1.4 kg in the insulin glargine group and a mean decrease of 0.8 kg in the standard care group.
Maltese: Waqt l-aħħar viżta ta' matul il-kura, kien hemm medja ta' żieda fil-piż tal-ġisem mil-linja bażi ta' 1.4 kg fil- grupp ta' insulin glargine u medja ta' tnaqqis ta' 0.8 kg fil-grupp ta' kura standard.
English: Each pen contains 3 ml of solution for injection (equivalent to 300 units).
Maltese: Kull pinna fiha 3 mL ta' soluzzjoni għall-injezzjoni (ekwivalenti għal 300 unità).
English: With the other hand pull off the pen cap.
Maltese: Kun ċert li tkellem tabib kmieni.
English: Solution for injection 1 pen of 3 ml 3 pens of 3 ml 5 pens of 3 ml 10 pens of 3 ml
Maltese: Soluzzjoni għall-injezzjoni Pinna 1 ta' 3 mL
English: In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
Maltese: F'pazjenti li għandhom indeboliment fil-funzjoni tal-kliewi, il-ħtieġa għall-insulina tista' tonqos dovuta minħabba t-tnaqqis tal-metaboliżmu ta' l-insulina.
English: D - Wipe the rubber seal (at the front of the cartridge) with a new alcohol wipe.
Maltese: D - Imsaħ is-siġill tal-lastku (fuq in-naħa ta' quddiem tal-iskartoċċ) b'imselħa bl-alkoħol ġdida.
English: Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Maltese: Pentamidine (użat għall-kura ta' xi infezzjonijiet ikkawżati mill-parassiti) jista' jikkawża l-ipogliċemija li kultant tkun segwita mill-ipergliċemija.
English: METHOD OF ADMINISTRATION
Maltese: Tab protettiv
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
Maltese: Tibdil fil-qawwa, fil-marka (il-manifattur), fit-tip (regolari, NPH, lente, effett fit-tul eċċ.), fl- oriġini (annimal, uman, insulina analoga umana) u/jew metodu ta' manifattura jista' jirriżulta fil-ħtieġa tat- tibdil tad-doża.
English: Switch from twice daily NPH insulin to Semglee
Maltese: ▬ Insulin glargine - NPH insulin
English: Suomi/Finland Mylan Finland OY Puh/Tel: + 358 20 720 9555
Maltese: België/Belgique/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00
English: PHARMACEUTICAL FORM Solution for injection in pre-filled pen.
Maltese: Mediċini użati fid-dijabete.
English: Complaints of injection site reactions (injection site reaction, injection site pain) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults.
Maltese: Ilmenti ta' reazzjonijiet fis-sit ta' l-injezzjoni (uġigħ fis-sit tal-injezzjoni, reazzjoni fis-sit tal-injezzjoni) u reazzjonijiet tal-ġilda (raxx, urtikarja) huma rrapportati relattivament aktar spiss fit-tfal u fl-adolexxenti ta' 18-il sena jew anqas, milli fl-adulti.
English: Insulin antibodies
Maltese: Antikorpi għall-insulina
English: There were no differences between insulin glargine and standard care for the two co-primary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome.
Maltese: Ma kien hemm ebda differenza bejn insulin glargine u l-kura standard għaż- żewġ lottijiet ta' riżultati primarji; għal kull komponent li jagħmel parti minn dawn ir-riżultati; għall-mewt minn kwalunkwe kawża; jew għar-riżultat compost mikrovaskulari.
English: Type I colourless glass cartridge with a plunger (bromobutyl rubber), sealed using lined seals (laminate of polyisoprene and bromobutyl rubber).
Maltese: Uża biss labar li huma kompatibbli għall-użu mal-pinna Semglee (ara “L-Istruzzjonijiet Dwar l-Użu”).
English: After first use of the pen, store it at room temperature up to 30°C.
Maltese: Wara li tuża l-pinna għall-ewwel darba, aħżinha fit-temperatura ambjentali sa 30oC.
English: Very rare reported side effects (may affect up to 1 in 10,000 people) In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.
Maltese: F'każijiet rari ħafna, jista' jkollok dysgeusia (disturbi fit-togħma) u majalġja (uġigħ muskolari).
English: Similar effects on glycohemoglobin and the incidence of symptomatic hypoglycemia were observed in both treatment groups, however fasting plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group.
Maltese: Fiż-żewġ gruppi ta' kura ġew osservati effetti simili fuq il-glikoemoglobina u fl-inċidenza ta' ipogliċemija sintomatika, madankollu kien hemm tnaqqis akbar mil-linja bażi fil-livell tal-glukożju fil-plażma fi s-stat ta' sawm fil-grupp tal-insulin glargine milli fil- grupp ta' NPH.
English: Hypoglycaemia (very common), in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement (see section 4.4).
Maltese: L-ipogliċemija (komuni ħafna), li ġeneralment hija l-aktar reazzjoni avversa frekwenti tat-terapija bl-insulina, tista' sseħħ meta d-doża ta' l-insulina tkun għolja aktar milli meħtieġ (ara sezzjoni 4.4).
English: Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Maltese: Studji fuq l-annimali ma wrewx tossiċità riproduttiva.
English: Switch from other insulins to Semglee
Maltese: Il-bidla minn tipi oħrajn ta' insulina għal Semglee
English: No metabolic effects of ingested insulin glargine on the breast-fed newborn/infant are anticipated since insulin glargine as a peptide is digested into aminoacids in the human gastrointestinal tract.
Maltese: Biex jiġu evitati żbalji fil-medikazzjoni bejn l- insulina glargine u insulini oħra, it-tikketta ta' l-insulina għandha tiġi ċċekkjata qabel kull injezzjoni.
English: Pen care
Maltese: Pinen fl-użu
English: In-use pens
Maltese: Għatu tal-pinna
English: EMA/319123/2014 EMEA/H/C/002655
Maltese: EMEA/H/C/002655
English: Envarsus is a ‘hybrid medicine'.
Maltese: Envarsus huwa ‘mediċina ibrida'.
English: Envarsus is available as prolonged-released tablets containing tacrolimus (0.75, 1 and 4 mg).
Maltese: Envarsus huwa disponibbli bħala pilloli ta' rilaxx imtawwal li fihom tacrolimus (0.75, 1 u 4 mg).
English: Treatment failure occurred in 18.3% patients treated with Envarsus (49 out of 268), and 19.6% given Prograf (54 out of 275).
Maltese: Falliment tal-kura seħħ fi 18.3% tal-pazjenti kkurati b'Envarsus (49 minn 268), u 19.6% li ngħataw Prograf (54 minn 275).
English: The full EPAR and risk management plan summary for Envarsus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Envarsus jistgħu jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tacrolimus, the active substance in Envarsus, is an immunosuppressive medicine.
Maltese: Tacrolimus, is-sustanza attiva f'Envarsus, huwa mediċina immunosopressiva.
English: Other information about Envarsus
Maltese: Informazzjoni oħra dwar Envarsus
English: This is a summary of the European public assessment report (EPAR) for Envarsus.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Envarsus.
English: Envarsus is a medicine that contains the active substance tacrolimus.
Maltese: Envarsus hija mediċina li fiha s-sustanza attiva tacrolimus.
English: Failure rates were 2.5% in both groups (4 of 162 patients treated with Envarsus, and 4 of 162 treated with Prograf).
Maltese: Ir-rati ta' falliment kienu 2.5% fiż-żewġ gruppi (4 minn 162 pazjenti kkurati b'Envarsus, u 4 minn 162 kkurati bi Prograf).
English: The most commonly reported side effects with Envarsus (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
Maltese: L-effetti sekondarji l-aktar komuni b'Envarsus (li dehru f'aktar minn pazjent 1 minn kull 10) huma rogħda, uġigħ ta' ras, dardir, dijarea, problemi fil-kliewi, ipergliċemija (livelli għoljin taz-zokkor fid
English: Because Envarsus is similar to the reference medicine Advagraf, the applicant provided comparative data on Advagraf.
Maltese: Minħabba li Envarsus huwa simili għall-mediċina ta' riferenza Advagraf, l-applikant ipprovda dejta komparattiva dwar Advagraf.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Envarsus on 18 July 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Envarsus fi 18 Lulju 2014.
English: Why is Envarsus approved?
Maltese: Għaliex ġie approvat Envarsus?
English: In the prevention of rejection, doses should start at 0.17 mg per kg of body weight daily in patients who have had a kidney transplant, and 0.11 to 0.13 mg per kg daily in those who have had a liver transplant.
Maltese: Fil-prevenzjoni ta' rifjut, id-dożi għandhom jibdew minn 0.17 mg għal kull kg tal-piż tal-ġisem kuljum f'pazjenti li kellhom trapjant tal-kliewi, u 0.11 sa 0.13 mg għal kull kg kuljum f'dawk li kellhom trapjant tal-fwied.
English: The reference medicine for Envarsus is Advagraf.
Maltese: Il-mediċina ta' referenza għal Envarsus hija Advagraf.
English: The company also provided studies on the levels of tacrolimus in the body after taking Envarsus, which showed that it produced levels of tacrolimus that have been previously shown to be effective in treating and preventing rejection, and reported results in 29 patients who were given Envarsus starting after a liver transplant, none of whom rejected the transplanted organ during the 360 days following transplantation.
Maltese: Il-kumpanija pprovdiet ukoll studji fuq il-livelli ta' tacrolimus fil-ġisem wara li jittieħed Envarsus, li juru li dan ipproduċa livelli ta' tacrolimus li ntwerew qabel li huma effettivi fil-kura u prevenzjoni ta' rifjut, u rrapportat riżultati f'29 pazjent li ngħataw Envarsus eżatt wara trapjant tal-fwied, fejn l-ebda minnhom ma rrifjutaw l-organu trapjantat waqt it-360 ġurnata ta' wara t-trapjant.
English: Envarsus tacrolimus
Maltese: Sommarju tal-EPAR għall-pubbliku tacrolimus
English: What are the risks associated with Envarsus?
Maltese: X'inhuma r-riskji assoċjati ma' Envarsus?
English: This means that Envarsus is similar to a ‘reference medicine' that contains the same active substance but Envarsus has been formulated in a different way and is available at different doses.
Maltese: Dan ifisser li Envarsus huwa simili għal ‘mediċina ta' referenza' li fiha l-istess sustanza attiva iżda Envarsus ġie fformulat b'mod differenti u huwa disponibbli f'dożi differenti.
English: The second study compared Envarsus with Prograf as part of standard treatment in 543 patients with a newly transplanted kidney.
Maltese: It-tieni studju qabbel Envarsus ma' Prograf bħala parti minn kura standard f'543 pazjent b'kilwa ġdida trapjantata.
English: A risk management plan has been developed to ensure that Envarsus is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Envarsus intuża bl-aktar mod sigur possibbli.
English: Tacrolimus reduces the activity of certain cells in the immune system, called T-cells, that are primarily responsible for attacking the transplanted organ (organ rejection).
Maltese: Tacrolimus inaqqas lattività ta' ċertu ċelloli fis-sistema immunitarja, imsejħa ċelloli-T, li huma primarjament responsabbli għall-attakki fuq l-organu trapjantat (rifjut tal-organu).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the approved doses of Envarsus have been shown to have a comparable quality, safety and effectiveness to Advagraf and Prograf.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li d-dożi approvati ta' Envarsus intwerew li għandhom kwalità, sigurtà u effikaċja komparabli ma' Advagraf u Prograf.
English: This summary was last updated in 07-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 07-2014.
English: Because tacrolimus is absorbed into the body differently from Envarsus than from other tacrolimus medicines, when switching patients who are already being treated with any other formulation of tacrolimus they should be given a dose of Envarsus 30% less than their existing dose.
Maltese: Minħabba li tacrolimus jiġi assorbit ġol-ġisem b'mod differenti minn Envarsus minn forom oħra ta' mediċini b'tacrolimus, meta l-pazjenti li diġà jkunu qed jiġu kkurati b'xi formulazzjoni oħra ta' tacrolimus jinqelbu għal fuq mediċina oħra, dawn għandhom jingħataw doża ta' Envarsus 30% inqas mid-doża eżistenti tagħhom.
English: Envarsus is often given with other immunosuppressive medicines following the transplant.
Maltese: Envarsus ta' spiss jingħata ma' mediċini immunosopressivi oħrajn wara trapjant.
English: Envarsus can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.
Maltese: Envarsus jista' jintuża wkoll biex jikkura rifjut ta' organu f'pazjenti adulti meta mediċini immunosopressivi oħrajn (mediċini li jnaqqsu l-attività tas-sistema immunitarja) mhumiex effettivi.
English: For the full list of all side effects reported with Envarsus see the package leaflet
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Envarsus ara l-fuljett ta' tagħrif.
English: The first study involved 326 patients who had already had a kidney transplant and were being treated with Prograf and other immunosuppressants to prevent rejection.
Maltese: L-ewwel studju involva 326 pazjent li diġà kellhom trapjant tal-kliewi u kienu qed jiġu kkurati bi Prograf u b'immunosopressivi oħrajn biex jipprevjenu rifjut.
English: Envarsus must not be used in patients who are hypersensitive (allergic) to tacrolimus or any of the other ingredients, nor in those who are allergic to substances called macrolides (which include antibiotics such as erythromycin).
Maltese: Envarsus m'għandux jintuża f'pazjenti li għandhom sensittività eċċessiva (allerġiċi) għal tacrolimus jew xi ingredjenti oħrajn, lanqas f'dawk li huma allerġiċi għal sustanzi msejħa macrolides (li jinkludu antibijotiċi bħal erythromycin).
English: These studies compared Envarsus with Prograf, a widely used and well-established tacrolimus medicine that releases tacrolimus more quickly.
Maltese: Dawn l-istudji qabblu Envarsus ma' Prograf, mediċina b'tacrolimus stabbilita sew u użata ħafna li tirrilaxxa tacrolimus iktar malajr.
English: In addition, because of the formulation/dosage differences between Envarsus and Advagraf, clinical studies in patients were also provided.
Maltese: Barra minn hekk, minħabba d-differenzi fil-formulazzjoni/dożaġġ bejn Envarsus u Advagraf, ġew ipprovduti wkoll studji kliniċi f'pazjenti.
English: Patients may also have abnormal results in liver function tests.
Maltese: Pazjenti jista' wkoll ikollhom riżultati mhux normali tat-testijiet tal-funzjoni talfwied.
English: The full EPAR for Adynovi 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.