FrancophonIA/ELRC3.0 huggingface dataset:
English: Biotransformation via CYP450 enzymes plays a minor role in the total metabolic clearance of aclidinium.
Maltese: Il-bijotrasformazzjoni permezz ta' enzimi CYP450 għandha rwol żgħir fit-tneħħija metabolika totali ta' aclidinium.
English: The main plasma protein that binds aclidinium is albumin.
Maltese: Il-proteina tal-plażma ewlenija li twaħħal aclidinium hija l-albumina.
English: N), or
Maltese: NUMRU(I)
English: The hydrolysis occurs both chemically (non-enzymatically) and enzymatically by esterases, butyrylcholinesterase being the main human esterase involved in the hydrolysis.
Maltese: L-idrolisi sseħħ kemm b'mod kimiku (mhux b'mod enzimatiku) kif ukoll b'mod enzimatiku b'esterasi, b'butyrylcholinesterase jkun l-esterase ewlieni tal-bniedem involut fl-idroliżi.
English: As Brimica Genuair contains aclidinium and formoterol, the type and severity of adverse reactions associated with each of the components may be expected with Brimica Genuair.
Maltese: Peress li Brimica Genuair fih aclidinium u formoterol, it-tip u s-severità tar-reazzjonijiet avversi assoċjati ma' kull wieħed mill-komponenti jistgħu jkunu mistennija b'Brimica Genuair.
English: Effects of aclidinium in nonclinical studies with respect to reproductive toxicity (foetotoxic effects) and fertility (slight decreases in conception rate, number of corpora lutea, and pre- and post implantation losses) were observed only at exposures considered sufficiently in excess of themaximum human exposure indication to be of little relevance to clinical use.
Maltese: Fi studji li mhumiex kliniċi fir-rigward tat-tossiċità riproduttiva (effetti fetotossiċi), u l-fertilità (tnaqqis żgħir fir-rata ta' konċepiment, numru ta' corpora lutea, u telf ta' qabel u wara l-impjant) l-effetti ta' aclidinium dehru biss wara esponimenti meqjusin ferm aktar għolja mill-massimu ta' esponiment fil-bniedem, li juru ftit li xejn rilevanza għall-użu kliniku.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics, ATC code: R03AL05
Maltese: Mediċini għal mard ostruttiv tal-passaġġi tal-arja, adrenerġiċi f'kombinazzjoni ma' antikolinerġiċi, Kodiċi ATC:
English: Patients with a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, QTc (Bazett's method) above 470 msec, or hospitalisation within the previous 12 months for heart failure functional classes III and IV as per the “New York Heart Association” were excluded from the clinical studies, therefore Brimica Genuair should be used with caution in these patients groups.
Maltese: Il-pazjenti b'infart mijokardijaku matul is-6 xhur preċedenti, b'anġina instabbli, b'arritmija li tkun għadha kif ġiet iddijanjostikata matul l-aħħar 3 xhur, QTc (metodu ta' Bazett) itwal minn 470 msek, jew li ddaħħlu l-isptar matul l-aħħar 12-il xahar għal insuffiċjenza kardijaka tal-klassijiet funzjonali
English: • Each time you load a dose by pressing the orange button, the dose indicator moves by a small amount towards the next number (50, 40, 30, 20, 10, or 0).
Maltese: • Kull darba li tħejji doża billi tagħfas il-buttuna l-oranġjo, l-indikatur tad-doża jiċċaqlaq b'ammont żgħir lejn in-numru li jmiss (50, 40, 30, 20, 10, jew 0).
English: Rash Pruritus
Maltese: Vista mċajpra
English: These may be signs of a condition called “paradoxical bronchospasm”, which is an excessive and prolonged contraction of the airway muscles immediately following treatment with a bronchodilator.
Maltese: Dawn jistgħu jkunu sinjali ta' kondizzjoni msejħa “bronkospażmu paradossikali” li hija kontrazzjoni eċċessiva u fit-tul tal-muskoli tal-passaġġ tal-arja immedjatament wara kura bi bronkodilatur.
English: Whole lung deposition of inhaled aclidinium via Genuair averaged approximately 30% of the metered dose.
Maltese: Id-depożitu sħiħ fil-pulmun ta' aclidinium permezz ta' Genuair kellu medja ta' bejn wieħed u ieħor 30% tad-doża mkejla.
English: Nonclinical studies investigating the effects of aclidinium/formoterol on cardiovascular parameters showed increased heart rates and arrhythmias at exposures sufficiently in excess of the maximum human exposure indication to be of little relevance to clinical use.
Maltese: L-istudji mhux kliniċi li jinvestigaw l-effetti ta' aclidinium/formoterol fuq il-parametri kardjovaskulari wrew żieda fir-rati ta' taħbit tal-qalb u arritmiji b'esponimenti ferm aktar għoljin mill-massimu ta' esponiment fil-bniedem, li juru ftit li xejn rilevanza għall-użu kliniku.
English: Dry mouth has been observed with medicines like Brimica Genuair.
Maltese: Ħalq xott ġie osservat b'mediċini bħal Brimica Genuair.
English: Do not use this medicine after the expiry date which is stated on the inhaler label, carton and inhaler bag after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta tal-inalatur, il-kartuna u l-borża tal-inalatur wara “JIS”.
English: Each delivered dose (the dose leaving the mouthpiece) contains 396 micrograms aclidinium bromide equivalent to 340 micrograms of aclidinium and 11.8 micrograms of formoterol fumarate dihydrate.
Maltese: Kull doża fornuta (id-doża li tħalli l-biċċa tal-ħalq) fiha 396 mikrogramma ta' aclidinium bromide (ekwivalenti għal 340 mikrogramma ta' aclidinium) u 11.8 mikrogramma ta' formoterol fumarate dihydrate.
English: How to store Brimica Genuair
Maltese: X'inhu Brimica Genuair
English: High doses of Brimica Genuair may lead to exaggerated anticholinergic and/or β2-adrenergic signs and symptoms; the most frequent of which include blurred vision, dry mouth, nausea, muscle spasm, tremor, headache, palpitations and hypertension.
Maltese: Dożi għoljin ta' Brimica Genuair jistgħu jwasslu għal sinjali u sintomi ta' antikolinerġiċi u/jew adrenerġiċi β2 esaġerati; li l-aktar frekwenti minnhom huma vista mċajpra, ħalq xott, dardir, spażmi fil-muskoli, rogħda, uġigħ ta' ras, palpitazzjonijiet u pressjoni għolja.
English: If you use more Brimica Genuair than you should If you think you may have used more Brimica Genuair than you should, you are more likely to experience some of its side effects, such as blurred vision, dry mouth, feeling sick, shaking/tremor, headache, palpitations or an increase in blood pressure, therefore you must immediately contact your doctor or go to the nearest emergency unit.
Maltese: Jekk taħseb li użajt Brimica Genuair aktar milli suppost, huwa aktar probabbli li jkollok xi effetti sekondarji tiegħu, bħal vista mċajpra, ħalq xott, dardir, rogħda/tertir, uġigħ ta' ras, palpitazzjonijiet jew żieda fil-pressjoni tad-demm, għaldaqstant għandek tikkuntattja immedjatament lit-tabib tiegħek jew tmur fl-eqreb taqsima ta' emerġenza.
English: Name and address of the manufacturer responsible for batch release Industrias Farmacéuticas Almirall, S.A.
Maltese: Industrias Farmacéuticas Almirall, S.A.
English: Uncommon - Fast heart beat (tachycardia) - Chest pain or tightness in the chest (angina pectoris) - Blurred vision - Changes in the sound of the voice (dysphonia) - Difficulty passing urine or a feeling that your bladder has not completely emptied (urinary retention) - An abnormal heart trace (QT interval prolongation) potentially leading to an abnormal heart rhythm - Distorted sense of taste (dysgeusia) - Throat irritation - Inflammation of the mouth (stomatitis) - Increased blood pressure - Agitation - Rash - Itching of the skin
Maltese: - Traċċar mhux normali tal-qalb (titwil tal-intervall QT) li potenzjalment iwassal għal ritmu mhux normali tal-qalb - Sens mibdul tat-togħma (disgewżja) - Irritazzjoni fil-griżmejn - Infjammazzjoni tal-ħalq (stomatite)
English: Renal impairment No dose adjustments are required in patients with renal impairment (see section 5.2).
Maltese: Indeboliment epatiku Ma huwa meħtieġ l-ebda aġġustament tad-doża fil-pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: Mouthpiece
Maltese: Faxxa
English: Plasma levels of the acid metabolite are approximately 100-fold greater than those of the alcohol metabolite and the unchanged active substance following inhalation.
Maltese: Il-livelli fil-plażma tal-metabolit tal-aċidu huma bejn wieħed u ieħor 100 darba akbar minn dawk tal-metabolit tal-alkoħol u s-sustanza attiva mhux mibdula ta' wara t-teħid man-nifs.
English: Cough
Maltese: GmbH.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for aclidinium bromide / formoterol fumarate dihydrate, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal aclidinium bromide / formoterol fumarate dihydrate, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: When aclidinium and formoterol were administered in combination by the inhaled route, the pharmacokinetics of each component showed no relevant differences from those observed when the medicinal products were administered separately.
Maltese: Meta aclidinium u formoterol ingħataw flimkien permezz ta' inalazzjoni, il-farmokokinetika ta' kull wieħed minnhom ma wriet ebda differenza rilevanti minn dik osservata meta l-prodotti mediċinali ngħataw b'mod separat.
English: Tooth abscess
Maltese: Axxessi tas-snin
English: Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium and formoterol (see section 5.3).
Maltese: Studji f'firien urew tnaqqis żgħir fil-fertilità biss f'livelli ta' doża ferm ogħla mill-espożizzjoni massima tal-bniedem għal aclidinium u formoterol (ara sezzjoni 5.3).
English: The low absolute bioavailability of inhaled aclidinium (<5%) is because aclidinium undergoes extensive systemic and pre-systemic hydrolysis whether deposited in the lung or swallowed.
Maltese: Il-bijodisponibilità assoluta baxxa ta' aclidinium meħud man-nifs (<5%) hija għaliex aclidinium jgħaddi minn idrolisi sistemika u presistemika estensiva kemm jekk iddepożitat fil-pulmun kif ukoll jekk jinbela'.
English: Getting Started:
Maltese: Ieqaf u Ċċekkja:
English: Studies in animals have shown foetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium and adverse effects in reproduction studies with formoterol at very high systemic exposure levels (see section 5.3).
Maltese: Studji f'annimali urew tossiċità fetali biss f'livelli ta' doża ferm ogħla mill-esponiment massimu tal-bniedem għal aclidinium u reazzjonijiet avversi fi studji dwar ir-riproduzzjoni b'formoterol f'livelli ta' esponiment sistemiku għoli ħafna (ara sezzjoni 5.3).
English: In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see section 4.5).
Maltese: F'pazjenti b'COPD severa, ipokalemija tista' titqawwa b'ipoksja u b'kura konkomitanti (ara sezzjoni 4.5).
English: These include: o corticosteroids that you take by mouth (such as prednisolone), o diuretics (such as furosemide or hydrochlorothiazide), o certain medicines used to treat breathing conditions (such as theophylline).
Maltese: Dawn jinkludu: o kortikosterojdi li tieħu mill-ħalq (bħal prednisolone). o dijuretiċi (bħal furosemide jew hydrochlorothiazide).
English: Since aclidinium bromide is quickly broken down in plasma, the level of systemic anticholinergic undesirable effects is low.
Maltese: Peress li aclidinium malajr jinqasam fil-plażma, il-livell ta' effetti sistemiċi antikolinġiċi mhux mixtieqa huwa wieħed baxx.
English: Bronchodilation is induced by causing direct relaxation of airway smooth muscle as a consequence of the increase in cyclic AMP through activation of adenylate cyclase.
Maltese: Bronkodilatazzjoni tiġi indotta billi jiġi kkawżat rilassament dirett tal-muskolu lixx tal-passaġġ tal-arja bħala konsegwenza taż-żieda fl-AMP ċikliku permezz tal-attivazzjoni ta' cyclase adenylate.
English: Inhaled aclidinium bromide acts locally in the lungs to antagonise M3 receptors of airway smooth muscle and induce bronchodilation.
Maltese: Aclidinium bromide li jittieħed man-nifs jaġixxi lokalment fil-pulmun sabiex jantagonizza r-riċetturi M3 tal-muskolu lixx tal-passaġġ tal-arja u jinduċi l-bronkodilatazzjoni.
English: Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of β2-adrenergic agonists, therefore caution is advised in their concomitant use (see section 4.4).
Maltese: Kura konkomitanti b'derivati ta' methylxanthine, sterojdi jew dijuretiċi li jħallu l-potassju joħroġ fl-awrina tista' żżid l-effett ipokalimiku possibbli ta' agonisti adrenerġiċi β2, għalhekk hija rakkomandata kawtela fl-użu konkomitanti tagħhom (ara sezzjoni 4.4).
English: Renal and urinary disorders Urinary retention
Maltese: Pazjenti b'indeboliment renali u epatiku
English: a.
Maltese: ĦA
English: Moreover, post-marketing reports of ‘peripheral oedema' did not show positive re-challenge.
Maltese: Barra minn hekk, rapporti ta' wara t-tqegħid fis-suq ta' “edema periferali” ma wrewx riesponiment pożittiv.
English: Brimica Genuair should be used with caution in patients with severe cardiovascular disorders, convulsive disorders, thyrotoxicosis and phaeochromocytoma.
Maltese: Brimica Genuair għandu jintuża b'kawtela f'pazjenti b'disturbi kardjovaskulari severi, b'disturbi konvulsivi, tirotossikożi u feokromoċitoma.
English: Locked
Maltese: Tqala
English: Agitation
Maltese: Svezzja
English: The presentation of the safety profile is based on the experience with Brimica Genuair and the individual components.
Maltese: Il-preżentazzjoni tal-profil tas-sigurtà hija bbażata fuq l-esperjenza b'Brimica Genuair u l-komponenti individwali.
English: COPD medicinal products
Maltese: IL-PRODOTT MEDIĊINALI
English: Taking Brimica Genuair regularly will reduce the effects of COPD on your everyday life.
Maltese: Jekk tieħu Brimica Genuair b'mod regolari, dan inaqqas l-effetti tas-COPD matul il-ħajja ta' kuljum tiegħek.
English: β-adrenergic blockers β-adrenergic blockers may weaken or antagonise the effect of β2-adrenergic agonists.
Maltese: L-imblokkaturi adrenerġiċi β jistgħu jdgħajfu jew jantagonizzaw l-effett tal-agonisti adrenerġiċi β2.
English: Rare (may affect up to 1 in 1,000 people) - Sudden difficulty in breathing or swallowing, swelling of the tongue, throat, lips or face, skin rash and/or itching - these may be signs of an allergic reaction
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna) - Diffikultà f'daqqa biex tieħu n-nifs jew tibla', nefħa tal-ilsien, griżmejn, xufftejn jew il-wiċċ, jew raxx u/jew ħakk tal-ġilda - dawn jistgħu jkunu sinjali ta' reazzjoni allerġika.
English: Do not use Brimica Genuair: - if you are allergic to aclidinium, formoterol fumarate dihydrate or to the other ingredient of this medicine (listed in Section 6).
Maltese: Tużax Brimica Genuair: - jekk inti allerġiku għal aclidinium, formoterol fumarate dihydrate jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-Sezzjoni 6).
English: Brimica Genuair 340 micrograms /12 micrograms inhalation powder
Maltese: Brimica Genuair 340 mikrogramma/12-il mikrogramma trab li jittieħed man-nifs.
English: As a consequence of the differential density of muscarinic receptors and β2-adrenoceptors in the central and peripheral airways of the lung, muscarinic antagonists should be more effective in relaxing central airways and β2-adrenergic agonists should be more effective in relaxing peripheral airways; relaxation of both central and peripheral airways with combination treatment may contribute to its beneficial effects on lung function.
Maltese: Bħala konsegwenza tad-densità differenti tar-riċetturi muskariniċi u l-adrenoriċetturi β2 fil-passaġġi tal-arja ċentrali u periferali tal-pulmun, l-antagonisti muskariniċi għandhom ikunu aktar effikaċi biex jirrilassaw il-passaġġi tal-arja ċentrali u l-agonisti adrenerġiċi β2għandhom ikunu aktar effikaċi biex jirrilissaw il-passaġġi tal-arja periferali; ir-rilassament kemm tal-passaġġi tal-arja ċentrali kif ukoll dawn periferali b'kura ta' kombinazzjoni jista' jikkontribwixxi għall-effetti ta' benefiċċju fuq il-funzjoni tal-pulmun.
English: In addition, Brimica Genuair statistically significantly delayed the time to first moderate or severe exacerbation compared to placebo (hazard ratio=0.70; p=0.027).
Maltese: Barra minn hekk, Brimica Genuair dewwem b'mod statistikament sinifikanti, il-ħin għall-ewwel taħrix moderat jew sever għal plaċebo (proporzjon ta' periklu =0.70; p=0.027).
English: No clinically relevant effects of Brimica Genuair on ECG parameters (including QT-interval) compared with aclidinium, formoterol and placebo were seen in Phase III studies of 6 to 12 months duration conducted in approximately 4,000 patients with COPD.
Maltese: Ma ntwera ebda effett klinikament rilevanti ta' Dukalir Genuair fuq il-parametri ECG (inkluż intervall tal-QT) meta mqabbel ma' aclidinium, formoterol u plaċebo fl-istudji ta' Fażi
English: INHALER LABEL
Maltese: TIKKETTA TAL-INALATUR
English: MA (EU) Number Name Strength Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla farmaċewtik a
English: Ifirmasta 75 mg Film-coated tablet
Maltese: Il-pakkett li jmiss mal-prodott
English: Teva Pharmaceutical Works Private Limited Company Pallagi Ut 13
Maltese: Teva Pharmaceutical Works Private Limited Company Pallagi út 13
English: C/C, n. 4, Poligono Industrial Malpica ES-50016 Zaragoza Spain
Maltese: C/C, n. 4, Poligono Industrial Malpica ES-50016 Zaragoza Spanja
English: It may harm them,
Maltese: insomnja (nuqqas ta' rqad)
English: Prilaz baruna Filipovica 25 10 000 Zagreb Croatia
Maltese: Prilaz baruna Filipovica 25 10 000 Zagreb Il-Kroazja
English: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren
English: Ostravská 29, č.p.
Maltese: Ostravská 29, c.p. 305
English: EU/1/17/1244/001 30 capsules EU/1/17/1244/002 30x1 capsules EU/1/17/1244/003 50 capsules EU/1/17/1244/004 50x1 capsules EU/1/17/1244/005 100 capsules EU/1/17/1244/006 100x1 capsules EU/1/17/1244/007 30 capsules EU/1/17/1244/008 30x1 capsules EU/1/17/1244/009 50 capsules EU/1/17/1244/010 50x1 capsules EU/1/17/1244/011 60 capsules EU/1/17/1244/012 60x1 capsules EU/1/17/1244/013 100 capsules EU/1/17/1244/014 100x1 capsules EU/1/17/1244/015 30 capsules EU/1/17/1244/016 30x1 capsules EU/1/17/1244/017 50 capsules EU/1/17/1244/018 50x1 capsules EU/1/17/1244/019 100 capsules EU/1/17/1244/020 100x1 capsules EU/1/17/1244/021 30 capsules EU/1/17/1244/022 30x1 capsules EU/1/17/1244/023 50 capsules EU/1/17/1244/024 50x1 capsules
Maltese: EU/1/17/1244/001 30 kapsula EU/1/17/1244/002 30x1 kapsula EU/1/17/1244/003 50 kapsula EU/1/17/1244/004 50x1 kapsula EU/1/17/1244/005 100 kapsula EU/1/17/1244/006 100x1 kapsula EU/1/17/1244/007 30 kapsula EU/1/17/1244/008 30x1 kapsula EU/1/17/1244/009 50 kapsula EU/1/17/1244/010 50x1 kapsula EU/1/17/1244/011 60 kapsula EU/1/17/1244/012 60x1 kapsula EU/1/17/1244/013 100 kapsula EU/1/17/1244/014 100x1 kapsula EU/1/17/1244/015 30 kapsula EU/1/17/1244/016
English: toxic epidermal necrolysis (Lyell's syndrome)
Maltese: nekrolisi tossika tal-ġilda (sindrome ta' Lyell)
English: Each capsule contains 537.25 mg lactose and 0.0154 mg ponceau 4R.
Maltese: Kull kapsula fiha 537.25 mg lactose u 0.0154 mg ponceau 4R.
English: 0.5 mg, 1 mg, 3 mg Contains lactose.
Maltese: 0.5 mg, 1 mg, 3 mg
English: Posterior reversible encephalopathy syndrome (PRES)
Maltese: Sindrome ta' enċefalopatija riversibbli ta' wara (PRES - Posterior reversible encephalopathy syndrome)
English: Capsule content Ethylcellulose Hypromellose 2910 Lactose monohydrate Magnesium stearate
Maltese: X'fiha l-kapsula Ethylcellulose Hypromellose 2910 Lactose monohydrate Magnesium stearate.
English: Significantly more ciclosporin-treated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02) (Keenan et al., Ann Thoracic Surg 1995;60:580).
Maltese: Sinifikattiv il-fatt li kien hemm aktar pazjenti li ħadu ciclosporin (n = 13) li kellhom jaqilbu għal tacrolimus milli pazjenti fuq tacrolimus li kellhom jaqilbu għal ciclosporin (n = 2) (p = 0.02) (Keenan et al., Ann Thoracic Surg 1995; 60:580).
English: Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.
Maltese: Shellac, propylene glycol, iron oxide iswed (E172), potassium hydroxide.
English: Intestinal transplantation
Maltese: Trapjant intestinali
English: Tacforius contains the active substance tacrolimus.
Maltese: Tacforius fih is-sustanza attiva tacrolimus.
English: - The active substance is tacrolimus.
Maltese: - Is-sustanza attiva hi tacrolimus
English: Propylene glycol Black iron oxide (E172) Potassium hydroxide
Maltese: Propylene glycol Iron oxide iswed (E172) Potassium hydroxide
English: Limited knowledge of interactions between tacrolimus and statins is available.
Maltese: Hemm għarfien limitat dwar interazzjonijiet bejn tacrolimus u statins.
English: Tacforius contains lactose
Maltese: Tacforius fih lactose
English: Lymphoproliferative disorders and malignancies
Maltese: Disturbi limfoproliferattivi u malinni
English: Tacforius is used in adults.
Maltese: Tacforius jingħata lil persuni adulti.
English: 98.8%) to plasma proteins, mainly to serum albumin and α - 1-acid glycoprotein.
Maltese: Fil plażma, tacrolimus jingħaqad ħafna (> 98.8%) mal-proteini tal-plażma, l-aktar mal-albumin tas-serum u l-α - 1-acid glycoprotein.
English: Tacrolimus is widely metabolised in the liver, primarily by the cytochrome P450 - 3A4.
Maltese: Tacrolimus jiġi metabolizzat ħafna fil-fwied, primarjament miċ-ċitokromju P450 - 3A4.
English: Each capsule contains 107.45 mg lactose.
Maltese: Kull kapsula fiha 107.45 mg lactose.
English: Tacforius is a once-a-day oral formulation of tacrolimus.
Maltese: Tacforius huwa formulazzjoni orali ta' tacrolimus li tittieћed darba kuljum.
English: Tacrolimus is extensively bound to plasma proteins.
Maltese: Tacrolimus jingħaqad estensivament mal-proteini tal-plażma.
English: Investigations very common: liver function tests abnormal common:
Maltese: Investigazzjonijiet komuni ħafna: testijiet tal-funzjoni tal-fwied mhux normali komuni:
English: The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000),
English: Each capsule contains 322.35 mg lactose.
Maltese: Kull kapsula fiha 322.35 mg lactose.
English: A lower incidence of acute rejection episodes for tacrolimus- versus ciclosporin-treated patients (11.5% versus 22.6%) and a lower incidence of chronic rejection, the bronchiolitis obliterans syndrome (2.86% versus 8.57%), was reported within the first year after transplantation.
Maltese: Fl-ewwel sena wara t-trapjant kienu rrappurtati inqas każi ta' episodji fejn kien hemm rifjut akut għal tacrolimus kontra pazjenti li ħadu ciclosporin (11.5% kontra 22.6%) u inqas inċidenza ta' rifjut kroniku u tas-sindrome bronkolite obliterans (2.86% kontra 8.57%).
English: pancreatic pseudocyst, subileus Hepatobiliary disorders common:
Maltese: psewdoċista pankreatika, subileus Disturbi fil-fwied u fil-marrara komuni:
English: Each capsule contains 53.725 mg lactose.
Maltese: Kull kapsula fiha 53.725 mg lactose.
English: Tacforius 5 mg prolonged-release hard capsules: red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), ponceau 4R (E124), gelatin.
Maltese: Tacforius 5 mg kapsuli ibsin li jerћu l-mediċina bil-mod: iron oxide aħmar (E172), iron oxide isfar (E172), titanium dioxide (E171), iron oxide iswed (E172), ponceau 4R (E124), gelatin Linka għall-istampar
English: thromboembolic and ischaemic events, vascular hypotensive disorders, haemorrhage, peripheral vascular disorders uncommon:
Maltese: avvenimenti trombemboliċi u iskemiċi, disturbi vaskulari ipotensivi, emorraġija, disturbi vaskulari fil-periferi mhux komuni:
English: Black iron oxide (E172)
Maltese: Iron oxide aħmar (E172)
English: Another randomised study included 66 patients on tacrolimus versus 67 patients on ciclosporin.
Maltese: Studju randomised ieħor kien jinkludi 66 pazjent li ħadu tacrolimus kontra 67 pazjent li ħadu ciclosporin.