FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 90 mg of cinacalcet (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 90 mg ta' cinacalcet (bħala hydrochloride).
English: Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).
Maltese: Mimpara jista' jintuża bħala parti minn kors terapewtiku li jinkludi phosphate binders u/jew sterols tal-Vitamina D, kif xieraq (ara sezzjoni 5.1).
English: Light green, oval (approximately 13.9 mm long and 8.7 mm wide), film-coated tablet marked “AMG” on one side and “90” on the other.
Maltese: Pillola miksija b'rita, ta' lewn aħdar ċar, ovali (b'tul ta' madwar 13.9 mm u wisa' ta' 8.7 mm), immarkata b'“AMG” fuq naħa waħda u “90” fuq in-naħa l-oħra.
English: • high potassium levels in the blood (hyperkalaemia)
Maltese: • livelli għolja ta' potassium fid-demm (iperkalimja)
English: Mean baseline iPTH concentrations across the 3 studies were 733 and 683 pg/mL (77.8 and 72.4 pmol/L) for the cinacalcet and placebo groups, respectively.
Maltese: Konċentrazzjonijiet medji fil-linja bażi ta' iPTH matul it-tliet studji kienu 733 u 683 pg/mL (77.8 u 72.4 pmol/L) għall-gruppi ta' cinacalcet u plaċebo, rispettivament. 66% tal-pazjenti kienu qed jirċievu sterols tal-vitamina D meta daħlu fl-istudju, u > 90% kienu qed jirċievu phosphate binders.
English: Switch from etelcalcetide to Mimpara
Maltese: Bidla minn etelcalcetide għal Mimpara
English: After titration to the maximum dose of Mimpara, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Mimpara therapy should be considered (see section 5.1).
Maltese: Wara titrazzjoni sad-doża massima ta' Mimpara, il-kalċju fis-serum għandu jiġi mmonitorjat perjodikament; jekk ma jinżammx tnaqqis klinikament rilevanti tal-kalċju fis-serum, għandu jiġi kkunsidrat twaqqif għal kollox tat-terapija b'Mimpara (ara sezzjoni 5.1).
English: The granules are not compatible with tubes made of polyurethane and silicone.
Maltese: Il-grani mhumiex kompatibbli ma' tubi magħmula minn polyurethane u silicone.
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 5 mg of cinacalcet (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull kapsula fiha 5 mg ta' cinacalcet (bħala hydrochloride).
English: Capsule consists of a rich yellow colour cap, marked “AMG” and white opaque body, marked “2.5 mg”.
Maltese: Il-kapsula tikkonsisti f'għatu ta' lewn isfar jgħajjat, immarkat b'“AMG” u korp abjad opak, immarkat b'“2.5 mg”.
English: The majority of patients (75%) were using vitamin D sterols at baseline.
Maltese: Il-maġġoranza tal-pazjenti (75%) kienu qed jużaw sterols tal-vitamina D fil-linja bażi.
English: Calcium-containing phosphate binders, vitamin D sterols and/or adjustment of dialysis fluid calcium concentrations can be used to raise serum calcium according to clinical judgment.
Maltese: Phosphate binders li fihom il-kalċju, sterols talvitamina D u/jew aġġustament tal-konċentrazzjonijiet tal-kalċju fil-fluwidu tad-dijalisi jistgħu jintużaw biex jgħollu l-kalċju fis-serum skont il-ġudizzju kliniku.
English: Mimpara 60 mg film-coated tablets
Maltese: Mimpara 60 mg, pillola Cinacalcet
English: Mimpara 5 mg granules in capsules for opening Gelatin
Maltese: Mimpara 5 mg grani f'kapsuli biex jinfetħu Gelatin
English: Light green, oval (approximately 9.7 mm long and 6.0 mm wide), film-coated tablet marked “AMG” on one side and “30” on the other.
Maltese: Pillola miksija b'rita, ta' lewn aħdar ċar, ovali (b'tul ta' madwar 9.7 mm u wisa' ta' 6.0 mm), immarkata b'“AMG” fuq naħa waħda u “30” fuq in-naħa l-oħra.
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/004
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/292/004
English: There were no effects on fertility in males or females at exposures up to 4 times a human dose of 180 mg/day (safety margins in the small population of patients administered a maximum clinical dose of 360 mg daily would be approximately half those given above).
Maltese: Ma kienx hemm effetti fuq il-fertilità fl-irġiel jew in-nisa f'esponimenti sa 4 darbiet id-doża umana ta' 180 mg/jum (marġini ta' siġurtà fil-popolazzjoni żgħira ta' pazjenti mogħtija id-doża klinika massima ta' 360 mg kuljum tkun madwar nofs dawk mogħtija hawn fuq).
English: A significantly higher percentage of cinacalcet-treated patients achieved mean corrected total serum calcium concentration ≤ 10.3 mg/dL (2.57 mmol/L) and ≥ 1 mg/dL (0.25 mmol/L) decrease from baseline in mean corrected total serum calcium concentration, when compared with the placebo-treated patients (75.8% versus 0% and 84.8% versus 5.9% respectively).
Maltese: 3 mg/dL (2.57 mmol/L) u tnaqqis ta' ≥ 1 mg/dL (0.25 mmol/L) mil-linja bażi fil-konċentrazzjoni medja ta' kalċju totali kkoreġut fis-serum, meta mqabbla mal-pazjenti ttrattati bil-plaċebo (75.
English: The safety of Mimpara for the treatment of secondary HPT in paediatric patients with ESRD receiving dialysis was evaluated in two randomised controlled studies and one single-arm study (see section 5.1).
Maltese: Is-sigurtà ta' Mimpara għat-trattament ta' HPT sekondarju f'pazjenti pedjatriċi b'ESRD li kienu qed jirċievu id-dijalisi ġiet evalwata f'żewġ studji randomised u kkontrollati u fi studju wieħed bi grupp wieħed (ara sezzjoni 5.1).
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Mimpara works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Maltese: Mimpara jaħdem billi jikkontrolla l-livelli tal-ormon tal-paratirojde (PHT - parathyroid hormone), tal-kalċju u tal-fosforu fil-ġisem tiegħek.
English: Medicinal products known to reduce serum calcium
Maltese: Prodotti mediċinali magħrufa li jnaqqsu l-kalċju fis-serum
English: The lack of effect of cinacalcet on the pharmacokinetics of R- and S-warfarin and the absence of auto-induction upon multiple dosing in patients indicates that cinacalcet is not an inducer of CYP3A4, CYP1A2 or CYP2C9 in humans.
Maltese: In-nuqqas ta' effett ta' cinacalcet fuq il-farmakokinetika ta' R- u S-warfarin u n-nuqqas ta' awto-induzzjoni wara dożaġġ multiplu fil-pazjenti jindika li cinacalcet mhux induttur ta' CYP3A4, CYP1A2 jew CYP2C9 fil-bnedmin.
English: Myalgia Muscle spasms Back pain
Maltese: Uġigħ fil-muskoli Spażmi fil-muskoli Uġigħ fid-dahar
English: The mean maximum daily dose of cinacalcet was 1.0 mg/kg/day.
Maltese: Id-doża medja massima ta' kuljum ta' cinacalcet kienet ta' 1.0 mg/kg/jum.
English: Granules
Maltese: Amgen
English: Smoking: Clearance of cinacalcet is higher in smokers than in non-smokers, likely due to induction of CYP1A2-mediated metabolism.
Maltese: It-tneħħija ta' cinacalcet hija ogħla f'persuni li jpejpu milli f'persuni li ma jpejpux, probabbilment minħabba induzzjoni ta' metaboliżmu medjat minn CYP1A2.
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/012
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/292/012
English: Corrected total serum calcium is above age-specified lower limit of normal, and
Maltese: Kalċju totali kkoreġut fis-serum huwa 'l fuq mil-limitu l-baxx tan-normal speċifikat għall-età, u
English: The frequencies of the individual preferred terms including angioedema and urticaria cannot be estimated from available data.
Maltese: Ma tistax tittieħed stima tal-frekwenzi ta' termini ppreferuti individwali li jinkludu anġjoedima u urtikarja mid-data disponibbli.
English: Concurrent administration of other medicinal products known to reduce serum calcium and Mimpara may result in an increased risk of hypocalcaemia (see section 4.4).
Maltese: L-għoti ta' prodotti mediċinali oħra magħrufa li jnaqqsu l-kalċju fis-serum flimkien ma' Mimpara jista' jwassal għal żieda fir-riskju ta' ipokalċimija (ara sezzjoni 4.4).
English: The normal calcium range differs depending on the methods used by your local laboratory and the age of the child/patient.
Maltese: Il-firxa normali tal-kalċju tvarja skont il-metodi wżati mil-laboratorju lokali tiegħek u l-età tat-tifel/tifla/pazjent.
English: • medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin);
Maltese: rifampicin u ciprofloxacin);
English: Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been reported in adults and children treated with Mimpara.
Maltese: Avvenimenti ta' theddida għall-ħajja u riżultati fatali assoċjati ma' livelli baxxi ta' kalċju (ipokalċimija) ġew irrappurtati f'adulti u tfal ittrattati b'Mimpara.
English: In the event that corrected serum calcium levels fall below 8.4 mg/dL (2.1 mmol/L) and/or symptoms of hypocalcaemia occur the following management is recommended:
Maltese: K'każ li l-livelli ta' kalċju kkoreġut fis-serum jonqsu taħt 8.4 mg/dL (2.1 mmol/L) u/jew iseħħu sintomi ta' ipokalċimija huwa rakkomandat l-immaniġġjar li jmiss:
English: Dose adjustment in paediatric patients ≥ 3 to < 18 years of age
Maltese: Aġġustament tad-doża f'pazjenti pedjatriċi ta' età minn ≥ 3 sa < 18-il sena
English: What Mimpara looks like and contents of the pack Mimpara granules are white to off-white in appearance and are presented in capsules for opening.
Maltese: Mimpara grani huma bojod sa offwajt u huma ppreżentati f'kapsuli biex jinfetħu.
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/013
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/292/013
English: An open-label extension of this study showed no further reductions in free and total testosterone concentrations over a period of 3 years in Mimpara-treated patients.
Maltese: Estensjoni open-label ta' dan l-istudju ma wrietx aktar tnaqqis fil-konċentrazzjoni ta' testosterone ħieles u fil-konċentrazzjoni ta' testosterone totali fuq perjodu ta' 3 snin f'pazjenti ttrattati b'Mimpara.
English: The majority of patients (91%) were using vitamin D sterols at baseline.
Maltese: Il-maġġoranza tal-pazjenti (91%)kienu qed jużaw sterols tal-vitamina D fil-linja bażi.
English: • abdominal pain, abdominal pain - upper
Maltese: • uġigħ fid-dahar • livelli baxxi ta kalċju fid-demm (ipokalċimija)
English: Hepatic Insufficiency: Mild hepatic impairment did not notably affect the pharmacokinetics of cinacalcet.
Maltese: Indeboliment ħafif tal-fwied ma affettwax il-farmakokinetika ta' cinacalcet b'mod notevoli.
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/014
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/292/014
English: • medicines used to treat changes in heart rate (flecainide and propafenone);
Maltese: • mediċini wżati għat-trattament ta' tibdil fir-rata tal-qalb (flecainide u propafenone);
English: Each bottle contains 30 tablets.
Maltese: U KONTENUT Flixkun wieħed fih 30 pillola.
English: NAME OF THE MEDICINAL PRODUCT Mimpara 1 mg granules in capsules for opening cinacalcet
Maltese: Mimpara 1 mg grani f'kapsuli biex jinfetħu cinacalcet
English: High Density Polyethylene (HDPE) bottle with a cotton coil, and a child-resistant polypropylene cap with an induction seal, packed into a carton.
Maltese: Flixkun ta' Polyethylene ta' Densità Għolja (HDPE - High Density Polyethylene) b'kolja tal-qoton, u għatu tal-polypropylene li ma jinfetaħx faċilment mit-tfal b'siġill ta' induzzjoni, ippakkjat ġo kartuna.
English: Cinacalcet was initiated at a dose of 30 mg twice daily and titrated to maintain a corrected total serum calcium concentration within the normal range.
Maltese: Cinacalcet inbeda b'doża ta' 30 mg darbtejn kuljum u ġie ttitrat biex tinżamm konċentrazzjoni ta' kalċju totali kkoreġut fis-serum fil-firxa normali.
English: • loss (anorexia) or decrease of appetite
Maltese: • telf (anoreksja ) jew tnaqqis ta' aptit
English: PTH levels should be assessed at least 12 hours after dosing with Mimpara.
Maltese: Il-livelli ta' PTH għandhom jiġu stmati tal-inqas 12-il siegħa wara li jingħata Mimpara.
English: Co-administration of 200 mg bid ketoconazole, a strong inhibitor of CYP3A4, caused an approximate 2-fold increase in cinacalcet levels.
Maltese: L-għoti flimkien ma' 200 mg bid ketoconazole, inibitur qawwi ta' CYP3A4, wassal għal żieda ta' madwar darbtejn fil-livelli ta' cinacalcet.
English: Mimpara 2.5 mg granules in capsules for opening
Maltese: Mimpara 2.5 mg grani f'kapsuli biex jinfetħu
English: The majority of patients (89%) were using vitamin D sterols at baseline.
Maltese: Il-maġġoranza tal-pazjenti (89%) kienu qed jużaw sterols tal-vitamina D fil-linja bażi.
English: Hypocalcaemia† Hyperkalaemia Reduced testosterone levels†
Maltese: Iperkalimja Tnaqqis fil-livelli ta' testosterone†
English: Do not swallow the capsule.
Maltese: Tiblax il-kapsula.
English: Thereafter, as cinacalcet levels begin to decline, PTH levels increase until 12 hours post-dose, and then PTH suppression remains approximately constant to the end of the once daily dosing interval.
Maltese: Minn hemm 'il quddiem, kif il-livelli ta' cinacalcet jibdew jonqsu, il-livelli ta' PTH jiżdiedu sa 12-il siegħa wara d-doża, u wara s-soppressjoni ta' PTH tibqa' bejn wieħed u ieħor kostanti sal-aħħar tal-intervall ta' dożaġġ ta' darba kuljum.
English: There have been reports of idiosyncratic cases of hypotension and/or worsening heart failure in cinacalcet-treated patients with impaired cardiac function in post-marketing safety surveillance, the frequencies of which cannot be estimated from available data.
Maltese: Kien hemm rapporti ta' każijiet idjosinkratiċi ta' pressjoni baxxa u/jew insuffiċjenza tal-qalb li tmur għall-agħar, f'pazjenti b'indeboliment fil-funzjoni tal-qalb li ngħataw cinacalcet waqt is-sorveljanza tas-sigurtà ta' wara t-tqegħid fis-suq, li l-frekwenzi tagħhom ma jistgħux jiġu stmati mid-data disponibbli.
English: • Hold each capsule upright (with the coloured cap on top).
Maltese: • Żomm kull kapsula wieqfa (bl-għatu kkulurit fuq).
English: Secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism Based on available data from patients receiving cinacalcet in placebo-controlled studies and single-arm studies the most commonly reported adverse reactions were nausea and vomiting.
Maltese: Ibbażat fuq data disponibbli minn pazjent li kienu qed jirċievu cinacalcet fi studji kkontrollati bilplacebo u studji bi grupp wieħed l-aktar reazzjonijiet avversi rrappurtati b'mod komuni kienu tqalligħ u rimettar.
English: The recommended starting dose for children aged ≥ 3 years to < 18 years is ≤ 0.20 mg/kg once daily based on the patient's dry weight (see table 1).
Maltese: Id-doża tal-bidu rakkomandata għal tfal b'età ta' ≥ 3 snin sa < 18-il sena hija ≤ 0.20 mg/kg darba kuljum ibbażata fuq il-piż niexef tal-pazjent (ara tabella 1).
English: Demographic and baseline characteristics were representative of the dialysis patient population with secondary HPT.
Maltese: Karatteristiċi demografiċi u tal-linja bażi kienu rappreżentattivi tal-popolazzjoni ta' pazjenti fuq dijalisi b'HPT sekondarju.
English: • For patients who have nasogastric or gastrostomy tubes, the granules can be administered with a small amount (at least 5 mL) of water using PVC tubing.
Maltese: • Għall-pazjenti li għandhom tubi nażogastriċi jew tal-gastrostomija, il-grani jistgħu jingħataw b'ammont żgħir (mill-inqas 5 mL) ta' ilma bl-użu ta' tubi tal-PVC.
English: The calcium sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH secretion.
Maltese: Mimpara huwa disponibbli wkoll bħala grani f'kapsuli biex jinfetħu.
English: Since cinacalcet is highly protein-bound, haemodialysis is not an effective treatment for overdose.
Maltese: Peress li cinacalcet jintrabat b'mod qawwi mal-proteini, l-emodijalisi mhix trattament effettiv għal doża eċċessiva.
English: QT prolongation and ventricular arrhythmia secondary to hypocalcaemia QT prolongation and ventricular arrhythmia secondary to hypocalcaemia have been identified during post-marketing use of Mimpara, the frequencies of which cannot be estimated from available data (see section 4.4).
Maltese: Sturdament u aċċessjonijiet, li jista' jkollhom effett qawwi ħafna fuq il-ħila biex issuq u tħaddem magni, ġew irrappurtati minn pazjenti li kienu qed jieħdu Mimpara (ara sezzjoni 4.4).
English: Mimpara 1 mg granules in capsules for opening
Maltese: Mimpara 1 mg grani f'kapsuli biex jinfetħu
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/015
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/292/015
English: Mimpara is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets.
Maltese: Mimpara huwa disponibbli fi fliexken b'pilloli miksija b'rita ta' 30 mg, 60 mg jew 90 mg, ġo kartuna.
English: Capsule consists of a dark green colour cap, marked “AMG” and white opaque body, marked “1 mg”.
Maltese: Il-kapsula tikkonsisti f'għatu ta' lewn aħdar skur, immarkat b'“AMG” u korp abjad opak, immarkat b'“1 mg”.
English: Amgen Biotechnologia Sp. z o.o.
Maltese: • Aħsel idejk sew bis-sapun u l-ilma.
English: NAME OF THE MEDICINAL PRODUCT Mimpara 90 mg film-coated tablets Cinacalcet
Maltese: Mimpara 90 mg pilloli miksija b'rita Cinacalcet
English: • 1 to 3 capsules a day use at least 1 tablespoon (15 mL)
Maltese: • 1 sa 3 kapsuli kuljum uża tal-inqas mgħarfa waħda (15mL)
English: Mimpara 5 mg granules in capsules for opening
Maltese: Mimpara 5 mg grani f'kapsuli biex jinfetħu
English: NAME OF THE MEDICINAL PRODUCT Mimpara 5 mg granules in capsules for opening cinacalcet
Maltese: Mimpara 5 mg grani f'kapsuli biex jinfetħu cinacalcet
English: • seizures (convulsions or fits)
Maltese: • aċċessjonijiet (konvulżjonijiet jew attakki epileptici)
English: The capsules are provided in High Density Polyethylene (HDPE) bottle with a foil induction seal and a child-resistant polypropylene cap, packed into a carton.
Maltese: Il-kapsuli huma pprovduti fi flixkun magħmul minn Polyethylene ta' Densità Għolja (HDPE - High Density Polyethylene) b'siġill ta' induzzjoni tal-fojl u għatu tal-polypropylene li ma jinfetaħx faċilment mit-tfal, ippakkjat ġo kartuna.
English: EMA/288552/2014 EMEA/H/C/003875
Maltese: EMEA/H/C/003875
English: The full EPAR and risk management plan summary for Ulunar Breezhaler 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 Ulunar Breezhaler jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ulunar Breezhaler indacaterol / glycopyrronium
Maltese: Ulunar Breezhaler indakaterol / glikopirronju
English: Glycopyrronium is a muscarinic receptor antagonist.
Maltese: Il-glikopirronju huwa antagonist tar-riċettur muskariniku.
English: Ulunar Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Maltese: Ulunar Breezhaler huwa mediċina li fiha żewġ sustanzi attivi, l-indakaterol (85 mikrogramma) u lglikopirronju (43 mikrogramma).
English: Indacaterol is a long-acting beta-2 agonist.
Maltese: L-indakaterol huwa agonist tal-beta-2 li jaġixxi fit-tul.
English: Ulunar Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
Maltese: Ulunar Breezhaler ġie studjat f'żewġ studji ewlenin li involvew total ta' 2,667 pazjent b'COPD.
English: It is used as maintenance (regular) treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Jintuża bħala kura ta' manteniment (regolari) biex itaffi s-sintomi ta' mard pulmonari ostruttiv kroniku (COPD) fl-adulti.
English: The reduction in the rate of exacerbations was 10 to 12% higher with Ulunar Breezhaler than with tiotropium and glycopyrronium.
Maltese: It-tnaqqis fir-rata ta' aggravamenti kien ta' 10 sa 12 % ogħla b'Ulunar Breezhaler milli bit-tiotropju u l-glikopirronju.
English: It works by attaching to beta-2-adrenergic receptors found in the muscles of many organs including the airways of the lungs.
Maltese: Jaħdem billi jeħel mar-riċetturi adrenerġiċi ta' beta-2 misjuba fil-muskoli ta' diversi organi inkluż il-passaġġi tal-arja tal-pulmuni.
English: This is a summary of the European public assessment report (EPAR) for Ulunar Breezhaler.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ulunar Breezhaler.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ulunar Breezhaler on 23 April 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ulunar Breezhaler fit-23 ta' April 2014.
English: Ulunar Breezhaler also increased FEV1 by 70 ml more than indacaterol alone and 90 ml more than glycopyrronium alone.
Maltese: Ulunar Breezhaler żied ukoll l-FEV1 b'70 ml aktar mill-indakaterol waħdu u 90 ml aktar mill-glikopirronju waħdu.
English: The effects of Ulunar Breezhaler when used to relieve symptoms of COPD were clinically meaningful.
Maltese: Leffetti ta' Ulunar Breezhaler meta użati biex itaffu s-sintomi tas-COPD kienu klinikament sinifikanti.
English: Why is Ulunar Breezhaler approved?
Maltese: Għal xiex ġie approvat Ulunar Breezhaler?
English: Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Maltese: B'mod komuni, l-antagonisti tar-riċetturi muskariniċi u l-agonisti ta' beta-2 fit-tul jiġu kkombinati fil-ġestjoni tas-COPD.
English: The company that makes Ultibro Breezhaler has agreed that its scientific data can be used for Ulunar Breezhaler (‘informed consent').
Maltese: Ilkumpanija li tipproduċi Ultibro Breezhaler qablet li d-dejta xjentifika tagħha tista' tintuża għal Ulunar Breezhaler (‘kunsens infurmat').
English: This medicine is the same as Ultibro Breezhaler, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal Ultibro Breezhaler, li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: Other information about Ulunar Breezhaler
Maltese: Kif jintuża Ulunar Breezhaler?
English: Regarding its safety, Ulunar Breezhaler is comparable to indacaterol and glycopyrronium used as separate medicines.
Maltese: Breezhaler jista' jitqabbel mal-indakaterol u l-glikopirronju użati bħala mediċini separati.
English: A risk management plan has been developed to ensure that Ulunar Breezhaler is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Ulunar Breezhaler jintuża bl-aktar mod sigur possibbli.
English: In the second study the average increase in FEV1 was 140 ml more with Ulunar Breezhaler treatment than with treatment with fluticasone and salmeterol.
Maltese: Fit-tieni studju, iż-żieda medja f'FEV1 kienet ta' 140 ml aktar bilkura ta' Ulunar Breezhaler milli bil-kura bil-flutikasone u s-salmeterol.
English: The active substances in Ulunar Breezhaler, indacaterol and glycopyrronium, work in different ways to widen the airways and improve breathing in COPD.
Maltese: Is-sustanzi attivi f'Ulunar Breezhaler, l-indakaterol u l-glikopirronju, jaħdmu b'modi differenti biex iwessgħu l-passaġġi tal-arja u jtejbu t-teħid tan-nifs f'COPD.
English: The most common side effects with Ulunar Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Maltese: L-effetti sekondarji l-aktar komuni b'Ulunar Breezhaler (li jistgħu jolqtu aktar minn 1 minn kull 10 persuni) huma l-infezzjonijiet fil-parti ta' fuq tal-passaġġ respiratorju (irjiħat).
English: What are the risks associated with Ulunar Breezhaler?
Maltese: X'inhuma r-riskji assoċjati ma' Ulunar Breezhaler?