FrancophonIA/ELRC3.0 huggingface dataset:
English: Two six-month supportive studies (M2-127 and M2-128) included patients with a history of COPD for at least 12 months prior to baseline.
Maltese: Żewġ studji ta' appoġġ li damu sitt xhur (M2-127 u M2-128) kienu jinkludu pazjenti bi storja medika ta' COPD għal mill-inqas 12-il xahar qabel il-linja bażi.
English: Exacerbation Category
Maltese: Kategorija t'Aggrav ar
English: If possible take your medicine and this leaflet with you.
Maltese: Jekk ikun possibbli, ħu l-mediċina u dan il-fuljett miegħek.
English: There is no evidence for an immunotoxic, skin sensitising or phototoxic potential.
Maltese: M'hemm l-ebda evidenza għal potenzjal immunotossiku, fototossiku jew sensibilizzazzjoni tal-ġilda.
English: Common side effects (may affect up to 1 in 10 people) - diarrhoea, nausea, stomach ache - weight decrease, decreased appetite - headache
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 f'10) - dijarea, nawsja, uġigħ fl-istonku - tnaqqis fil-piż, nuqqas ta' aptit - uġigħ ta' ras
English: Daxas 250 micrograms tablets Roflumilast
Maltese: Daxas 250 mikrogramma pilloli roflumilast
English: Daxas 250 micrograms tablets roflumilast
Maltese: Daxas 250 mikrogramma pilloli Roflumilast
English: Respiratory tract infections (excluding Pneumonia)
Maltese: Infezzjonijiet tal-apparat respiratorju (ħlief ilPnewmonja)
English: Pregnancy There are limited amount of data from the use of roflumilast in pregnant women.
Maltese: Tqala Hemm dejta limitata dwar l-użu ta' roflumilast f'nisa tqal.
English: It is not known whether roflumilast is dialysable by peritoneal dialysis.
Maltese: Mhux magħruf jekk roflumilast jistax jitneħħa permezz ta' dijalisi peritoneali.
English: Following intravenous or oral administration of radiolabelled roflumilast, about 20% of the radioactivity was recovered in the faeces and 70% in urine as inactive metabolites.
Maltese: Wara l-għoti ġo vina jew l-għoti orali ta' roflumilast radjutikkettat, madwar 20% tar-radjuattività kienet irkuprata fl-ippurgar u 70% fl-awrina bħala metaboliti inattivi.
English: The plasma AUC of the N-oxide metabolite on average is about 10-fold greater than the plasma AUC of roflumilast.
Maltese: L-AUC fil-plażma tal-metabolit N-oxide bħala medja hi ta' madwar 10 darbiet aktar mill-AUC filplażma ta' roflumilast.
English: Rate Ratio
Maltese: U KWANTITATTIVA
English: In addition, in vitro studies demonstrated no induction of the CYP1A2, 2A6, 2C9, 2C19, or 3A4/5 and only a weak induction of CYP2B6 by roflumilast.
Maltese: Flimkien ma' dan, studji in vitro wrew li m'hemm l-ebda induzzjoni ta' CYP1A2, 2A6, 2C9, 2C19, jew 3A4/5 u induzzjoni dgħajfa biss ta' CYP2B6 minn roflumilast.
English: The tested dose of fluvoxamine was 50 mg. A combination of roflumilast with these active substances might lead to an increase of exposure and persistent intolerability.
Maltese: Kombinazzjoni ta' roflumilast ma' dawn is-sustanzi attivi tista' twassal għal żieda fl-espożizzjoni u intollerabilità persistenti.
English: The incidence was 2.5% vs 2.2% in patients with a baseline body weight ≥60 kg, treated with roflumilast when compared to those treated with placebo.
Maltese: L-inċidenza kienet ta' 2.5% vs 2.2% f'pazjenti b'piż tal-ġisem fil-linja bażi ta' ≥60 kg, għal dawk trattati b'roflumilast meta mqabbla ma' dawk trattati bi plaċebo.
English: Steady state plasma concentrations of roflumilast and its N-oxide metabolite are reached after approximately 4 days for roflumilast and 6 days for roflumilast N-oxide following once-daily dosing.
Maltese: Il-konċentrazzjonijiet ta' roflumilast u l-metabolit tiegħu N-oxide fl-istat fiss fil-plażma jintlaħqu wara madwar 4 ijiem għal roflumilast u 6 ijiem għal roflumilast N-oxide wara dożaġġ ta' darba kuljum.
English: Marketing Authorisation Holder AstraZeneca AB
Maltese: AstraZeneca AB
English: A slight reduction in male fertility was seen in conjunction with epididymal toxicity in rats.
Maltese: Tnaqqis żgħir fil-fertilità fl-irġiel kien osservat flimkien ma' tossiċità epididimali fil-firien.
English: Rare side effects (may affect up to 1 in 1,000 people) - male breast enlargement - decreased sense of taste - respiratory tract infections (excluding pneumonia) - bloody stools, constipation - elevation of liver or muscle enzymes (seen in blood tests) - wheals (urticaria).
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 f'1000) - tkabbir tas-sider fl-irġiel - tnaqqis fis-sens tat-togħma - infezzjonijiet tal-apparat respiratorju (li jeskludu l-pnewmonja) - ippurgar bid-demm, stitikezza - żieda fl-enzimi tal-fwied jew tal-muskoli (osservati fit-testijiet tad-demm) - nefħa fil-ġilda (urtikarja).
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g.multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daxas should not be initiated or should be stopped in these patients.
Maltese: In-nuqqas ta' esperjenza f'pazjenti b'infezzjoni bl-HIV jew epatite attiva, b'mard immunoloġiku sever (eż. sklerosi multipla, lupus eritematuż, lewkoenċefalopatija multifokali) jew li jkunu kkurati b'terapijaimmunosoppressiva (minbarra kortikosterojdi sistemiċi għal żmien qasir) u li Daxas m'għandux jinbeda jew għandu jitwaqqaf f'dawn il-pazjenti.
English: The Marketing Authorisation Holder shall agree the content and format of the updated educational material with the national competent authority.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jaqbel dwar il-kontenut u l-format tal-materjal edukattiv aġġornat mal-awtorità kompetenti nazzjonali.
English: 2-Sided p-value
Maltese: TAGĦRIF
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daxas (see section 4.3).
Maltese: Pazjenti b'indeboliment moderat jew sever epatiku ikklassifikat bħala Child-Pugh B jew Ċ m'għandhomx jieħdu Daxas (ara sezzjoni 4.3).
English: Roflumilast is a PDE4 inhibitor, a non-steroid, anti-inflammatory active substance designed to target both the systemic and pulmonary inflammation associated with COPD.
Maltese: Roflumilast hu inibitur ta' PDE4, sustanza attiva mhux-sterojde, kontra l-infjammazzjoni maħsub biex jimmira kemm l-infjammazzjoni sistemika kif ukoll dik pulmonari, assoċjati ma' COPD.
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C should not take roflumilast (see section 4.3).
Maltese: Pazjenti b'indeboliment moderat jew sever epatiku ikklassifikat bħala Child-Pugh B jew Ċ m'għandhomx jieħdu roflumilast (ara sezzjoni 4.3).
English: There was a trend towards a reduction in moderate or severe exacerbations in subjects treated with roflumilast compared with placebo over 52 weeks, which did not achieve statistical significance (Table 2).
Maltese: Kien hemm xejra lejn tnaqqis f'aggravar moderat jew sever f'individwi trattati b'roflumilast meta mqabbla ma' plaċebo fuq 52 ġimgħa, li ma laħaqx sinifikat statistiku (Tabella 2).
English: Each Daxas 250 micrograms tablet contains 250 micrograms roflumilast.
Maltese: Kull pillola ta' 250 mikrogramma ta' Daxas fiha 250 mikrogramma ta' roflumilast.
English: White to off-white, round tablet, 5 mm in diameter, embossed with “D” on one side and “250” on the other side.
Maltese: Pilloli tondi, bojod għal offwajt, b'dijametru ta' 5 mm, intaljati b'“D” fuq naħa waħda u “250” fuq innaħa l-oħra.
English: Thus, the N-oxide metabolite is considered to be the main contributor to the total PDE4 inhibitory activity in vivo.
Maltese: Għaldaqstant, il-metabolit N-oxide hu kkunsidrat li hu l-kontributur ewlieni għall-attività inibitorja totali ta' PDE4 in vivo.
English: These findings consisted mainly of gastrointestinal findings (i.e. vomiting, increased gastric secretion, gastric erosions, intestine inflammation) and cardiac findings (i.e. focal haemorrhages, haemosiderin deposits and lympho-histiocytic cell infiltration in the right atria in dogs, and decreased blood pressure and increased heart rate in rats, guinea pigs and dogs).
Maltese: Dawn is-sejbiet kienu jikkonsistu primarjament f'sejbiet gastrointestinali (i.e. rimettar, żieda fit-tnixxija gastrika, tgħawwir gastriku, infjammazzjoni fl-imsaren) u sejbiet kardijaċi (i.e. emorraġiji fokali, depożiti ta' emosiderin u infiltrazzjoni limfo-istoċitika ta' ċelluli fl-atriji tal-lemin fil-klieb, u tnaqqis fil-pressjoni tad-demm u żieda fir-rata ta' taħbit tal-qalb fil-firien, fniek tal-Indi u klieb).
English: Each tablet contains 250 micrograms roflumilast.
Maltese: Kull pillola fiha 250 mikrogramma ta' roflumilast.
English: The potential risk of malignant tumours and the lack of experience in patients with past history of cancer.
Maltese: Ir-riskju potenzjali ta' tumuri malinni u n-nuqqas ta' esperjenza f'pazjenti bi storja medika ta' kanċer.
English: Rodent-specific toxicity in the nasal mucosa was observed in repeat-dose toxicity and carcinogenicity studies.
Maltese: Tossiċità speċifika għal annimali gerriema fil-mukuża nażali kienet osservata fi studji li saru dwar tossiċità u karċinoġeneċità minn dożi ripetuti.
English: Each film-coated tablet (tablet) contains 500 micrograms roflumilast.
Maltese: Kull pillola miksija b'rita (pillola) fiha 500 mikrogramma ta' roflumilast.
English: In Phase I studies, the following symptoms were observed at an increased rate after single oral doses of 2,500 micrograms and one single dose of 5,000 micrograms (ten times the recommended dose): headache, gastrointestinal disorders, dizziness, palpitations, light-headedness, clamminess and arterial hypotension.
Maltese: Fi studji ta' Fażi 1, is-sintomi li ġejjin ġew osservati f'rata ikbar wara dożi orali waħedhom ta' 2,500 mikrogramma u doża waħda ta' 5,000 mikrogramma (għaxar darbiet id-doża rakkomandata): uġigħ ta' ras, mard gastrointestinali, sturdament, palpitazzjonijiet, mejt, tidlik tal-ġilda minħabba lgħaraq u pressjoni arterjali baxxa.
English: Roflumilast improved lung function after 4 weeks (sustained over 52 weeks).
Maltese: Roflumilist tejjeb il-funzjoni tal-pulmun wara 4 ġimgħat (sostnut fuq 52 ġimgħa).
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX07
Maltese: Mediċini għal mard ostruttiv fil-pajp tan-nifs, mediċini sistemiċi oħrajn għal mard ostruttiv fil-pajp tan-nifs, kodiċi ATC:
English: BLISTERS
Maltese: Nawseja
English: This helps to stop narrowing of airways occurring in chronic obstructive pulmonary disease (COPD).
Maltese: Dan jgħin biex iwaqqaf it-tidjiq tal-passaġġi tan-nifs li jseħħ f'mard pulmonari ostruttiv kroniku (COPD).
English: This mechanism of action and the selectivity also apply to roflumilast N-oxide, which is the major active metabolite of roflumilast.
Maltese: Dan il-mekkaniżmu ta' azzjoni u s-selettività japplikaw ukoll għal roflumilast N-oxide, li hu l-metabolit attiv maġġuri ta' roflumilast.
English: The incidence observed was also higher in patients less than 75 years old, treated with roflumilast when compared to those treated with placebo (3.1% vs 2.0%).
Maltese: L-inċidenza osservata kienet ukoll ogħla f'pazjenti li għadhom m'għalqux 75 sena, trattati b'roflumilast meta mqabbla ma' dawk trattati bi plaċebo (3.1% kontra 2.0%).
English: Slovenská republika AstraZeneca AB, o.z.
Maltese: - Is-sustanzi l-oħra huma:
English: Co-administration with an antacid (combination of aluminium hydroxide and magnesium hydroxide) did not alter the absorption or pharmacokinetics of roflumilast or its N-oxide.
Maltese: L-għoti flimkien ma' antaċidu (kombinazzjoni ta' aluminium hydroxide u magnesium hydroxide) ma bidilx l-assorbiment jew il-farmakokinetika ta' roflumilast jew tal-N-oxide tiegħu.
English: Daxas is not recommended if you have one or more of the following diseases: - severe immunological diseases such as HIV infection, multiple sclerosis (MS), lupus erythematosus (LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function
Maltese: (LE), jew lewkoenċefalopatija multifokali progressiva (PML) - mard sever akut u infettiv bħal tuberkulożi, jew epatite akuta - kanċer (ħlief karċinoma taċ ċelluli bażali, tip ta' kanċer tal ġilda li jikber bil mod) - jew indeboliment sever tal-funzjoni tal-qalb.
English: Daxas 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Maltese: Daxas 500 mikrogramma pilloli miksija b'rita huma sofor, pilloli miksija b'rita b'forma tal-ittra D, imnaqqxa b'‘D' fuq naħa waħda.
English: Daxas is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.
Maltese: Daxas jintuża bħala terapija ta' manteniment ta' COPD severa fl-adulti li fil-passat tagħhom kellhom sintomi ta' COPD li marru għall-agħar b'mod frekwenti (dawk li jissejħu aggravamenti) u li għandhom bronkite kronika.
English: Special clinical conditions
Maltese: GĦAMLA KWALITATTIVA
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 din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: Roflumilast did not significantly reduce the rate of exacerbations compared with placebo in the subgroup of patients with moderate COPD.
Maltese: Roflumilast ma naqqasx b'mod sinifikanti r-rata ta' aggravamenti meta mqabbel malplaċebo fis-sottogrupp ta' pazjenti b'COPD moderat.
English: • cancer
Maltese: • kanċer
English: Dysgeusia
Maltese: Plaċebo
English: Severe
Maltese: Aggravament
English: The one-year studies included patients with a history of severe to very severe COPD [FEV1 (forced expiratory volume in one second) ≤50% of predicted] associated with chronic bronchitis, with at least one documented exacerbation in the previous year and with symptoms at baseline as determined by cough and sputum score.
Maltese: L istudji li damu sena kienu jinkludu pazjenti bi storja medika ta' COPD minn sever sa sever ħafna [FEV1 (volum respiratorju sfurzat f'sekonda) ta' ≤50% ta' dak previst] assoċjat ma' bronkite kronika, b'mill inqas aggravament wieħed dokumentat fis sena ta' qabel u b'sintomi fil linja bażi kif stabbilit minn punteġġ ta' sogħla u sputum.
English: This starting dose is intended to reduce adverse events and patient discontinuation when initiating therapy, but it is a sub-therapeutic dose.
Maltese: Din id-doża tal-bidu għandha l-għan li tnaqqas l-avvenimenti avversi u t-twaqqif tat-terapija, iżda hija doża sottoterapewtika.
English: Daxas 250 micrograms tablets
Maltese: Daxas 250 mikrogramma pilloli
English: Moderate or severe
Maltese: Moderat jew sever
English: In clinical studies and post-marketing experience, rare instances of suicidal thinking and behaviour (including suicide) were reported.
Maltese: Fl-istudji kliniċi u l-esperjenza ta' wara t-tqegħid tal-prodott fis-suq, kienu rrappurtati każijiet rari ta' ħsibijiet u mġiba suwiċidali, (inkluż suwiċidju).
English: This effect seems to be due to an ADCP (4-Amino-3,5-dichloro-pyridine) N-oxide intermediate specifically formed in rodent olfactory mucosa, with special binding affinity in these species (i.e. mouse, rat and hamster).
Maltese: Jidher li l-effett hu minħabba intermedju ADCP (4-Amino-3,5-dichloro-pyridine) N-oxide li jifforma speċifikament fil-mukuża olfattorja ta' annimali gerriema, b'affinità speċjali ta' twaħħil f'dawn l-ispeċi (fil-ġrieden, firien u ħamster).
English: Since roflumilast is highly protein bound, haemodialysis is not likely to be an efficient method of its removal.
Maltese: Billi roflumilast jeħel ħafna mal-proteina, lemodijalisi mhijiex mistennija li tkun metodu effiċjenti għattneħħija tiegħu.
English: There are no clinical data to support the concomitant treatment with theophylline for maintenance therapy.
Maltese: M'hemm l-ebda dejta klinika biex tissapportja l-kura fl-istess ħin b'theophylline għal terapija ta' manteniment.
English: Treatment with roflumilast may lead to a higher risk of sleep disorders (mainly insomnia) in patients with a baseline body weight of <60 kg, due to a higher total PDE4 inhibitory activity found in these patients (see section 4.8).
Maltese: It-trattament b'roflumilast jista' jwassal għal riskju akbar ta' disturbi fl-irqad (prinċipalment insomnja) f'pazjenti b'piż tal-ġisem fil-linja bażi ta' < 60 kg, minħabba attività inibitorja totali ogħla ta' PDE4 li tinsab f'dawn il-pazjenti (ara sezzjoni 4.8).
English: In 1-year studies (M2-124, M2-125), a decrease of body weight occurred more frequently in patients treated with roflumilast compared to placebo-treated patients.
Maltese: Fl-istudji li damu sena (M2-124, M2-125), tnaqqis fil-piż tal-ġisem seħħ iktar b'mod frekwenti f'pazjenti li kienu kkurati b'roflumilast meta mqabbel ma' pazjenti kkurati bi plaċebo.
English: Clinical data are considered insufficient to recommend dose adjustment and caution should be observed in patients with mild liver impairment (Child-Pugh A).
Maltese: Dejta klinika hi kkunsidrata li hi insuffiċjenti biex wieħed jirrakkomanda aġġustament fid-doża, u għandu jkun hemm kawtela f'pazjenti b'indeboliment ħafif tal-fwied (Child-Pugh A).
English: The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Daxas are provided with an updated Educational pack.
Maltese: Dan ser jippermetti identifikazzjoni ta' malajr ta' informazzjoni ġdida dwar is-sigurtà.
English: In older people, females and in non-Caucasians, total PDE4 inhibitory activity was increased.
Maltese: F'persuni akbar fl-età, nisa u persuni mhux Kawkasi, l-attività inibitorja totali ta' PDE4 żdiedet.
English: 26.3%, respectively).
Maltese: 3%, rispettivament).
English: 40549 Düsseldorf Germany
Maltese: 40549 Düsseldorf
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: L-iktar reazzjonijiet avversi serji kienu emorraġija gastrointestinali (mhux komuni) u stitikezza (komuni).
English: Triethyl citrate Titanium dioxide Talc
Maltese: Triethyl citrate Titanium dioxide
English: Intestinal obstruction*
Maltese: Ostruzzjoni intestinali*
English: Manufacturer allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
Maltese: Manifattur allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
English: Intestinal obstruction and ileus/subileus
Maltese: Ostruzzjoni intestinali u ileus/subileus
English: BindRen lowered the bioavailability of digoxin by 16% and Cmax by 17%, and the Cmax of enalapril by 27%.
Maltese: BindRen naqqas il bijodisponibilità ta' digoxin b'16% u s-Cmax bi 17%, u s-Cmax ta' enalapril b'27%.
English: Aluminium/polychlorotrifluoroethylene/PVC blister.
Maltese: Folja tal-aluminju/polychlorotrifluoroethylene/PVC.
English: Film-coating Ethylcellulose Hypromellose Macrogol 8000
Maltese: Kisja tar-rita Ethylcellulose Hypromellose Macrogol 8000
English: Allergic dermatitis, guttae psoriasis
Maltese: Dermatite allerġika, psorjażi guttae
English: Folate deficiency
Maltese: Defiċjenza ta' folate
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 January 2013
Maltese: Data tal-ewwel awtorizzazzjoni: 21 Jannar 2013
English: Foil laminate (polyethylene terephthalate/polyethylene/aluminium foil/polyethylene/polyvinylidene chloride) sachets.
Maltese: Qratas ta' laminat tal-fojl (polyethylene terephthalate/polyethylene/fojl talaluminju/polyethylene/polyvinylidene chloride).
English: Gastrointestinal haemorrhage
Maltese: Emorraġija gastrointestinali
English: Pack sizes of 45, 99, 198, 270 or 297 tablets per carton.
Maltese: Daqsijiet tal-pakkett ta' 45, 99, 198, 270 or 297 pillola f'kull kartuna.
English: A tabulated list of frequencies was defined using the following convention: 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) and not known (cannot be estimated from the available data).
Maltese: Lista tabulata ta' frekwenzi ġiet definita bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Colestilan significantly reduced serum LDL-cholesterol by 17.8, 25.6, 29.4, 34.8 and 33.4% at 3, 6, 9, 12 and 15 g/day at week 12 compared to placebo in fixed-dose study, respectively.
Maltese: Colestilan naqqas b'mod sinifikanti il-kolesterol LDL fis-serum bi 17.8, 25.6, 29.4, 34.8 u 33.4% f'dożi ta' 3, 6, 9, 12 u 15 g/kuljum f'ġimgħa 12 meta mqabbel mal-plaċebo fl-istudju ta' doża fissa, rispettivament.
English: BindRen contains the active substance colestilan.
Maltese: BindRen fih is-sustanza attiva colestilan.
English: INFORMATION IN BRAILLE BindRen 1 g tablets
Maltese: INFORMAZZJONI BIL-BRAILLE BindRen 1 g pilloli
English: BindRen 2 g granules BindRen 3 g granules colestilan
Maltese: BindRen 2 g grani BindRen 3 g grani colestilan
English: Serum glycosylated haemoglobin A1c
Maltese: Emoglobina A1c glycosylated fis-serum
English: Acetic acid esters of mono- and diglycerides of fatty acids Polysorbate 80
Maltese: Acetic acid esters ta' mono u diglycerides ta' aċidi grassi Polysorbate 80
English: After one year of treatment, a reduction of 1.12% in HbA1c was observed.
Maltese: Wara sena ta' kura, ġie osservat tnaqqis ta' 1.12% fl-HbA1c.
English: Granules.
Maltese: Grani.
English: Fixed-dose study:
Maltese: Studji fit-tul:
English: The other ingredients are: purified water, hydroxypropylcellulose, colloidal, anhydrous silica, hydrogenated castor oil, ethylcellulose, hypromellose, macrogol 8000, triethyl citrate, titanium dioxide, talc, cetanol and sodium laurilsulfate.
Maltese: hydrogenated castor oil, ethylcellulose, hypromellose, macrogol 8000, triethyl citrate, titanium dioxide, talc, cetanol u sodium laurilsulfate.
English: Pack sizes: 30, 60 or 90 sachets per carton.
Maltese: Daqsijiet tal-pakkett: 30, 60 jew 90 qratas f'kull kartuna.
English: Tel/Tel./ Teл./Tlf/Tél/Sími/Τηλ: +44 (0) 20 7382 9000 medinfo@mt-pharma-eu.com
Maltese: Tel./Tel./ Teл./Tlf/Tél/Sími/Τηλ: +44
English: The other ingredients are purified water, hydroxypropylcellulose, colloidal, anhydrous silica, hydrogenated castor oil, hypromellose, acetic acid esters of mono- and diglycerides of fatty acids, polysorbate 80, shellac, indigo carmine aluminium lake (E132) and carnauba wax.
Maltese: hydrogenated castor oil, hypromellose, acetic acid esters ta' mono u diglycerides ta' fatty acids, polysorbate 80, shellac, indigo carmine aluminium lake (E132) u carnauba wax.
English: Serum uric acid
Maltese: Uric acid fis-serum
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Sussegwentament, id-detentur tal awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Fertility No data are available to assess the potential influence of BindRen on fertility.
Maltese: M'hemmx dejta disponibbli biex tiġi evalwata l-influwenza potenzjali ta' BindRen fuq il-fertilità.
English: The reductions in LDL-cholesterol are also reflected in significant falls in total cholesterol.
Maltese: It-tnaqqis fil-kolesterol LDL huwa rifless ukoll fi tnaqqis sinifikanti fil-kolesterol totali.
English: Systemic ion balance
Maltese: Bilanċ sistemiku tal-joni
English: Granules 30 sachets 60 sachets 90 sachets
Maltese: Grani 30 qartas 60 qartas 90 qartas