FrancophonIA/ELRC3.0 huggingface dataset:
English: Opinion following an Article 33(4)1 referral for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Maltese: 10 mg/ml Soluzzjoni li Titferra' għall-ifrat u n-nagħaġ u Deltanil 100 mg Soluzzjoni għall-Użu Lokalizzat għall-ifrat
English: 10 November 2011
Maltese: 10 ta' Novembru 2011
English: 1 Article 78 of Directive 2001/82/EC
Maltese: 1 L-Artikolu 78 tad-Direttiva 2001/82/KE
English: The rapporteur and co-rapporteur appointed were Dr JeanClaude Rouby and Dr David Murphy, respectively.
Maltese: Ir-relatur u l-ko-relatur maħtura kienu Dr Jean-Claude Rouby u Dr David Murphy, rispettivament.
English: Committee for medicinal products for veterinary use (CVMP)
Maltese: Kumitat għal prodotti mediċinali għall-użu veterinarju (CVMP)
English: Opinion following an Article 78
Maltese: Opinjoni wara proċedura skont l-Artikolu 78
English: The final opinion was converted into a Decision by the European Commission on 3 November 2011.
Maltese: L-opinjoni finali nqelbet f'Deċiżjoni mill-Kummissjoni Ewropea fit-3 ta' Novembru 2011.
English: HIPRABOVIS PNEUMOS Emulsion for injection for cattle is an inactivated vaccine for reduction of the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age.
Maltese: HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-frat huwa vaċċin inattivat għat-tnaqqis tassinjali kliniċi u ta' leżjonijiet fil-pulmun ikkawżati minn Mannheimia haemolytica serotip A1 u Histophilus somni f'għoġġiela mill-età ta' xahrejn.
English: procedure for
Maltese: II.
English: The procedure started on 5 May 2011.
Maltese: Il-proċedura bdiet fil-5 ta' Mejju 2011.
English: Based on the rapporteurs' assessment of the data available from pharmacovigilance reports and a laboratory study, the CVMP concluded that the underlying cause of the adverse events observed has yet to be determined; the data evaluated indicated an association between vaccination of cattle with HIPRABOVIS PNEUMOS Emulsion for injection for cattle and the occurrence of anaphylactic-type events; no corrective measures could be recommended; and the benefit-risk balance for the product was unfavourable.
Maltese: Abbażi tal-valutazzjoni tar-relaturi tad-dejta disponibbli minn rapporti ta' farmakoviġilanza u minn studju fil-laboratorju, is-CVMP ikkonkluda li l-kaġun prinċipali tal-avvenimenti avversi osservati għad irid jiġi stabbilit; id-dejta evalwata indikat rabta bejn il-vaċċinazzjoni ta' frat bi HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-frat u l-okkorrenza ta' avvenimenti tat-tip anafilattiċi; ma setgħet tiġi rrakkomandata l-ebda miżura korrettiva; u l-bilanċ tal-benefiċċju-riskju għall-prodott ma kienx wieħed favorevoli.
English: Due to concerns regarding reports of anaphylactic-type events following use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle, France suspended the marketing authorisation for the product on 6 April 2011 triggering a procedure under Article 78 of Directive 2001/82/EC.
Maltese: Minħabba tħassib dwar rapport ta' avvenimenti tat-tip anafilattiċi wara l-użu ta' HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-frat, Franza ssospendiet l-awtorizzazzjoni għat-tqegħid fis-suq għallprodott fis-6 ta' April 2011 u tat bidu għal proċedura skont l-Artikolu 78 tad-Direttiva 2001/82/KE.
English: The Committee, adopted on 14 July 2011, an opinion recommending the suspension of the marketing authorisations for HIPRABOVIS PNEUMOS Emulsion for injection for cattle and associated names until the marketing authorisation holder proposes appropriate measures to mitigate the risk of occurrence of such adverse events and demonstrates a favourable benefit-risk balance for the product when used according to the recommendations of the summary of product characteristics The list of product names concerned is given in Annex I. The scientific conclusions and grounds for suspension of the marketing authorisations are provided in Annex II.
Maltese: Fl-14 ta' Lulju 2011, il-Kumitat adotta opinjoni li tirrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-frat u ismijiet assoċjati sakemm id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq jipproponi miżuri xierqa biex itaffu r-riskju ta' okkorrenza ta' avvenimenti avversi bħal dawn u juri bilanċ favorevoli tal-benefiċċjuriskju għall-prodott meta użat skont ir-rakkomandazzjonijiet tas-sommarju tal-karatteristiċi tal-prodott Il-lista tal-ismijiet tal-prodott hija mogħtija fl-Anness I.
English: A written explanation was provided by the representative of the marketing authorisation holder on 23 May 2011.
Maltese: Ġiet ipprovduta spjegazzjoni bil-miktub mir-rappreżentant taddetentur tal-awtorizzazzjoni għat-tqegħid fis-suq fit-23 ta' Mejju 2011.
English: HIPRABOVIS PNEUMOS Emulsion for injection for cattle and associated names
Maltese: HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għallfrat u ismijiet assoċjati
English: It may harm them,
Maltese: - reazzjonijiet allerġiċi (antiistamini),
English: ZA des Gailletrous 41260 La Chaussée Saint Victor France
Maltese: ZA des Gailletrous 41260 La Chaussée Saint Victor Franza
English: ATC code: R03AL09.
Maltese: R03AL09.
English: See also section 4, “Possible side effects”.
Maltese: Ara wkoll sezzjoni 4, “Effetti sekondarji possibbli”.
English: EU/1/18/1275/001 EU/1/18/1275/002 EU/1/18/1275/003 EU/1/18/1275/004 EU/1/18/1275/005
Maltese: EU/1/18/1275/001 EU/1/18/1275/002 EU/1/18/1275/003 EU/1/18/1275/004
English: MedDRA system organ class
Maltese: Klassi tas-sistemi u talorgani MedDRA
English: • formoterol fumarate dihydrate and
Maltese: • formoterol fumarate dihydrate u
English: Similar effects were seen when comparing Riarify with the extemporary triple combination.
Maltese: Effetti simili kienu osservati meta Riarify kien imqabbel mal-kombinazzjoni tripla estemporanja.
English: The number of puffs remaining is displayed in intervals of 20.
Maltese: In-numru ta' nefħiet li jkun fadal jintwera f'intervalli ta' 20.
English: Cytochrome P450 isoenzymes CYP2D6, CYP2C19 and CYP2C9 are involved in the O-demethylation of formoterol.
Maltese: L-isoenzimi taċċitokroma P450 CYP2D6, CYP2C19 u CYP2C9 huma involuti fl-O-demethylation ta' formoterol.
English: Angioedema1
Maltese: Anġjoedema1
English: EU/1/18/1275/004 EU/1/18/1275/005
Maltese: EU/1/18/1275/005
English: Date of first authorisation: 23 April 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' April 2018
English: The renal clearance of formoterol is 150 mL/min.
Maltese: It-tneħħija ta' formoterol mill kliewi hija ta' 150 mL/min.
English: After dispensing:
Maltese: Tużax Riarify:
English: Absorption, distribution and biotransformation
Maltese: Assorbiment, distribuzzjoni u bijotrasformazzjoni
English: Angina pectoris (stable1 and unstable), ventricular extrasystoles1, nodal rhythm, sinus bradycardia
Maltese: Angina pectoris (stabbli1 u instabbli), extrasystoles ventrikulari1, ritmu nodali, bradikardija tas-sinus
English: At least 65% of the fraction that is swallowed is absorbed from the gastrointestinal tract.
Maltese: Mill-inqas 65% tal-frazzjoni li tinbela' hija assorbita mill-apparat gastro intestinali.
English: Use with a spacer
Maltese: Effett ta' spacer
English: Related to formoterol
Maltese: Relatat ma' formoterol
English: Prior to dispensing: Store in a refrigerator (2°C-8°C).
Maltese: Aħżen fi friġġ (2°C-8°C).
English: Adrenal suppression1
Maltese: Soppressjoni adrenali1
English: The systemic availability of the active metabolite arises from lung (36%) and from gastrointestinal absorption of the swallowed dose.
Maltese: Id-disponibilità sistemika tal-metabolit attiv tiġi mill-pulmun (36%) u minn assorbiment gastrointestinali tad-doża li tinbelgħa.
English: These improvements were statistically significant (p < 0.001).
Maltese: Dan it-titjib kien statistikament sinifikanti (p < 0.001).
English: CYP2D6 was found to be the only enzyme responsible for glycopyrronium metabolism.
Maltese: CYP2D6 instab li kienet l-unika enzima responsabbli għall-metaboliżmu ta' glycopyrronium.
English: Compared with tiotropium, Riarify significantly improved IC by 39 mL (p = 0.025) and 60 mL (p = 0.001) after 26 and 52 weeks of treatment respectively.
Maltese: Meta mqabbel ma' tiotropium, Riarify tejjeb l-IC b'mod sinifikanti b'39 mL (p = 0.025) u 60 mL (p = 0.001) wara 26 u 52 ġimgħa ta' trattament rispettivament.
English: The terminal elimination half-lives are 0.5 hours and 2.7 hours for beclometasone dipropionate and beclometasone 17-monopropionate respectively.
Maltese: Il-half-lives tal-eliminazzjoni terminali huma 0.5 sigħat u 2.7 sigħat għal beclometasone dipropionate u beclometasone 17-monopropionate, rispettivament.
English: Excipients: anhydrous ethanol, hydrochloric acid; propellant: norflurane.
Maltese: Eċċipjenti: anhydrous ethanol, hydrochloric acid; propellant: norflurane.
English: Pack sizes of 1 container of 60, 120 or 180 actuations and multipacks of 2 or 3 containers of 120 actuations each.
Maltese: Daqsijiet tal-pakkett ta' kontenitur wieħed ta' 60, 120 jew 180 attwazzjoni, u pakketti multipli ta' 2 jew 3 kontenituri ta' 120 attwazzjoni kull wieħed.
English: • a container providing 120 puffs
Maltese: • kontenitur li jipprovdi 120 nefħa
English: • a container providing 60 puffs
Maltese: • kontenitur li jipprovdi 60 nefħa
English: Dermatitis allergic1
Maltese: Dermatite allerġika1
English: Vision, blurred1 (see also section 4.4)
Maltese: Vista, imċajpra1 (ara wkoll sezzjoni 4.4)
English: • if you are due to have an anaesthetic.
Maltese: • jekk se tingħata anestetiku.
English: The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium.
Maltese: Is-sustanzi attivi huma: beclometasone dipropionate, formoterol fumarate dihydrate u glycopyrronium.
English: The absolute bioavailability following inhalation is approximately 2% and 62% of the nominal dose for unchanged beclometasone dipropionate and beclometasone 17-monopropionate respectively.
Maltese: Il-bijodisponibilità assoluta wara inalazzjoni hija madwar 2% u 62% tad-doża nominali għal beclometasone dipropionate mhux mibdul u beclometasone 17-monopropionate, rispettivament.
English: • a container providing 180 puffs.
Maltese: • kontenitur li jipprovdi 180 nefħa.
English: In addition, L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.
Maltese: Barra dan, L-dopa, L-thyroxine, oxytocin u alkoħol jistgħu jnaqqsu t-tolleranza tal-qalb għal simpatomimetiċi beta2.
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000 persuna):
English: Do not expose to temperatures higher than 50°C.
Maltese: Tesponix għal temperaturi ogħla minn 50°C.
English: IMPORTANT: Do not perform steps 2 to 5 too quickly.
Maltese: Twettaqx passi 2 sa 5 malajr wisq.
English: Repeat dose toxicity
Maltese: Effett tossiku minn dożi ripetuti
English: Glucuronide acid conjugate is inactive.
Maltese: Il-konjugat ta' glucuronide acid huwa inattiv.
English: The second major pathway involves O-demethylation followed by conjugation at the phenolic 2'-hydroxyl group.
Maltese: O-demethylation segwit minn konjugazzjoni tal-grupp phenolic 2'-hydroxyl.
English: See section 4.4 and section 5.2.
Maltese: Ara sezzjoni 4.4 usezzjoni 5
English: Related to Riarify
Maltese: Relatat ma' Riarify
English: Multipack: 360 actuations (3 pressurised containers of 120 actuations each).
Maltese: Pakkett b'ħafna: 360 attwazzjoni (3 kontenituri għal kontenut taħt pressjoni għolja ta' 120 attwazzjoni kull wieħed).
English: Glaucoma1, cataract1
Maltese: Glawkoma1, katarretti1
English: The (R,R)- and (S,S)-enantiomers represented about 40% and 60% of unchanged active substance excreted in the urine, respectively.
Maltese: enantjomeri (R,R) u (S,S) irrappreżentaw madwar 40% u 60% tas-sustanza attiva mhux mibdula mneħħija fl-awrina, rispettivament.
English: Oedema peripheral1
Maltese: Edima periferali1
English: Absorption of formoterol is linear following inhalation of 12 to 96 micrograms of formoterol.
Maltese: L-assorbiment ta' formoterol huwa lineari wara inalazzjoni ta' 12 sa 96 mikrogramma ta' formoterol.
English: Multipack: 240 actuations (2 pressurised containers of 120 actuations each).
Maltese: Pakkett b'ħafna: 240 attwazzjoni (2 kontenituri għal kontenut taħt pressjoni għolja ta' 120 attwazzjoni kull wieħed).
English: Store at 25°C for a maximum of 4 months.
Maltese: Aħżen f'temperatura ta' 25°C għal massimu ta' 4 xhur.
English: The frequency of adverse reactions is 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
Maltese: (≥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: Safety pharmacology
Maltese: Farmakoloġija tas-sigurtà
English: The Phase III clinical development programme in COPD included two 52-week active-controlled studies.
Maltese: III dwar żvilupp kliniku f'COPD inkluda żewġ studji kkontrollati b'sustanza attiva ta' 52 ġimgħa.
English: The total systemic exposure (as measured by AUC0-t) was slightly reduced for beclometasone 17-monopropionate (by 37%) and formoterol (by 24%), while it was increased for glycopyrronium (by 45%).
Maltese: L-esponiment sistemiku totali (kif imkejjel permezz ta' AUC0-t) kien kemxejn imnaqqas għal beclometasone 17-monopropionate (b'37%) u formoterol (b'24%), filwaqt li żdied għal glycopyrronium (b'45%).
English: Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong the QT interval and increase the risk of ventricular arrhythmias.
Maltese: Trattament flimkien ma' quinidine, disopyramide, procainamide, antiistamini, inibituri ta' monoamine oxidase, antidepressanti triċikliċi u phenothiazines jista' jtawwal l-intervall QT u jżid r-riskju ta'
English: Chiesi Hellas AEBE Τηλ: + 30 210 6179763
Maltese: Τηλ: + 30 210 6179763
English: There is a risk of worsening shortness of breath and wheezing immediately after using Riarify and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people).
Maltese: Hemm riskju ta' aggravar tal-qtugħ ta' nifs u tħarħir immedjatament wara li tuża Riarify u dan huwa magħruf bħala bronkospażmu paradossali (jista' jaffettwa sa persuna waħda minn kull 1,000 persuna).
English: Formoterol: hypokalaemia, hyperglycaemia, tremor, palpitations, muscle spasms, electrocardiogram QT prolonged, blood pressure increased, blood pressure decreased, atrial fibrillation, tachycardia, tachyarrhythmia, angina pectoris (stable and unstable), ventricular extrasystoles, nodal rhythm.
Maltese: Formoterol: ipokalemija, ipergliċemija, rogħda, palpitazzjonijiet, spażmi fil-muskoli, titwil tal-QT fuq l-elettrokardjogramm, żieda fil-pressjoni, tnaqqis fil-pressjoni, fibrillazzjoni tal-atriju, takikardija, takiarritmija, angina pectoris (stabbli u instabbli), extrasystoles ventrikulari, ritmu nodali.
English: Plasma protein binding of formoterol is 61-64% with 34% bound to albumin.
Maltese: L-irbit mal-proteini fil-plażma ta' formoterol huwa ta' 61-64%,
English: Compared with tiotropium, Riarify also reduced the rate of severe exacerbations (i.e. excluding moderate exacerbations) by 32% (rate: 0.067 versus 0.098 events per patient/year; p = 0.017).
Maltese: Riarify naqqas ukoll ir-rata ta' episodji ta' aggravar sever (jiġifieri episodji ta' aggravar moderat kienu esklużi) bi 32% (rata: 0.067 kontra 0.098 avveniment għal kull pazjent/sena; p = 0.017).
English: • feeling worried, nervous, over-excited or irritable.
Maltese: • tħossok inkwetat, nervuż, eċċitat wisq jew irritabbli.
English: Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions.
Maltese: Trattament flimkien ma' inibituri ta' monoamine oxidase, inklużi prodotti mediċinali bi kwalitajiet simili bħal furazolidone u procarbazine, jista' jikkawża reazzjonijiet ta' pressjoni għolja.
English: 180 actuations
Maltese: 180 attwazzjoni
English: However, an increase in total systemic exposure of up to 2.5-fold was observed in subjects with severe renal impairment (glomerular filtration rate below 30 mL/min/1.73 m2), as a consequence of a significant reduction of the amount excreted in urine (approximately 90% reduction of glycopyrronium renal clearance).
Maltese: Madankollu, ġiet osservata żieda fl-esponiment sistemiku totali sa 2.5 darbiet f'individwi b'indeboliment sever tal-kliewi (rata ta' filtrazzjoni glomerulari inqas minn 30 mL/min/1.73 m2), bħala konsegwenza ta' tnaqqis sinifikanti fl-ammont eliminat fl-awrina (tnaqqis ta' madwar 90% fit-tneħħija ta' glycopyrronium mill-kliewi).
English: Cough, productive cough1, throat irritation, epistaxis1
Maltese: Sogħla, sogħla produttiva1, irritazzjoni fil-griżmejn.
English: There is a theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole.
Maltese: Hemm potenzjal teoretiku ta' interazzjoni f'pazjenti partikularment sensittivi li jieħdu disulfiram jew metronidazole.
English: Riarify contains beclometasone dipropionate, formoterol and glycopyrronium in a solution formulation resulting in an aerosol with extrafine particles with an average mass median aerodynamic diameter (MMAD) of around 1.1 micrometres and co-deposition of the three components.
Maltese: Riarify fih beclometasone dipropionate, formoterol u glycopyrronium f'formulazzjoni ta' soluzzjoni li twassal għal aerosol b'partiċelli fini ħafna b'dijametru aerodinamiku medjan tal-massa (MMADmass median aerodynamic diameter) medju ta' madwar 1.1 mikrometri u ko-depożizzjoni tat-tliet komponenti.
English: This endpoint was only measured in study TRINITY.
Maltese: Dan il-punt aħħari kien imkejjel biss flistudju TRINITY.
English: TDI was only measured in study TRILOGY.
Maltese: TDI kien imkejjel biss fl-istudju TRILOGY.
English: It is important to use Riarify every day.
Maltese: Huwa importanti li tuża Riarify kuljum.
English: The use of Riarify with the AeroChamber Plus spacer in COPD patients increased the lung delivery of beclometasone 17-monopropionate, formoterol and glycopyrronium (maximum plasma concentration increased by 15%, 58% and 60% respectively).
Maltese: L-użu ta' Riarify bl-ispacer AeroChamber Plus f'pazjenti b'COPD żied it-twassil fil-pulmun ta' beclometasone 17-monopropionate, formoterol u glycopyrronium (il-konċentrazzjoni massima fil plażma żdiedet bi 15%, 58% u 60% rispettivament).
English: • some anaesthetics can increase the risk of abnormal heart rhythms.
Maltese: • xi anestetiċi jistgħu jżidu r-riskju ta' ritmu tal-qalb mhux normali.
English: The pharmacokinetics of beclometasone dipropionate in patients with hepatic impairment has not been studied, however, as beclometasone dipropionate undergoes a very rapid metabolism via esterase enzymes present in intestinal fluid, serum, lungs and liver to form the more polar products beclometasone 21-monopropionate, beclometasone 17-monopropionate and beclometasone, hepatic impairment is not expected to modify the pharmacokinetics and safety profile of beclometasone dipropionate.
Maltese: Il-farmakokinetika ta' beclometasone dipropionate f'pazjenti b'indeboliment tal-fwied ma ġietx studjata, madankollu, peress li beclometasone dipropionate jgħaddi minn metaboliżmu mgħaġġel ħafna permezz ta' enzimi esterase preżenti fil-fluwidu intestinali, fis-serum, fil-pulmuni u fil-fwied biex jifforma l-prodotti aktar polari beclometasone 21-monopropionate, beclometasone 17-monopropionate u beclometasone, indeboliment tal-fwied mhux mistenni li jimmodifika l-profil farmakokinetiku u tas-sigurtà ta' beclometasone dipropionate.
English: A total of 3,346 patients were treated with beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium 87 micrograms/5 micrograms/9 micrograms at the target dose regimen (two inhalations twice daily) in multiple dose studies.
Maltese: Total ta' 3,346 pazjent kienu ttrattati b'beclometasone dipropionate/formoterol fumarate dihydrate /glycopyrronium 87 mikrogramma/5 mikrogrammi/9 mikrogrammi bil-kors tad-doża mmirata (żewġ inalazzjonijiet darbtejn kuljum) fi studji b'dożi multipli.
English: After oral administration (40 to 80 micrograms), 6% to 10% of the dose was recovered in urine as unchanged active substance in healthy subjects; up to 8% of the dose was recovered as the glucuronide.
Maltese: Wara għoti orali (40 sa 80 mikrogramma), 6% sa 10% taddoża kienet irkuprata fl-awrina bħala sustanza attiva mhux mibdula f'individwi f'saħħithom; sa 8% tad-doża kienet irkuprata bħala glucuronide.
English: Mean renal clearance was similar across the range of doses tested and after single and repeated inhalation (range 281-396 mL/min).
Maltese: It-tneħħija medja mill-kliewi kienet simili tul il-firxa ta' dożi ttestjati u wara inalazzjoni waħda u ripetuta (firxa 281-396 mL/min).
English: Formoterol is widely metabolised and the prominent pathway involves direct conjugation at the phenolic hydroxyl group.
Maltese: Bijotrasformazzjoni Formoterol jiġi metabolizzat b'mod estensiv u r-rotta prinċipali tinvolvi konjugazzjoni diretta tal grupp phenolic hydroxyl.
English: 120 and 180 actuation pressurised container: 22 months.
Maltese: Kontenitur għal kontenut taħt pressjoni għolja b'120 u 180 attwazzjoni: 22 xahar.
English: Very rare (may affect up to 1 in 10,000 people):
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000 persuna):
English: Dispensing date dd/mm/yyyy
Maltese: Data meta ngħata jj/xx/ssss
English: Glycopyrronium: glaucoma, atrial fibrillation, tachycardia, palpitations, dry mouth, dental caries, dysuria, urinary retention, urinary tract infection.
Maltese: Glycopyrronium: glawkoma, fibrillazzjoni tal-atriju, takikardija, palpitazzjonijiet, ħalq xott, taħsir fissnien, disurja, żamma tal-awrina, infezzjoni fil-passaġġ urinarju.
English: For instructions for use, see section 6.6.
Maltese: Għal istruzzjonijiet dwar l-użu, ara sezzjoni 6.6.
English: • monoamine oxidase inhibitors (MAOIs), including medicines with similar properties like furazolidone and procarbazine, used to treat mental disorders, can cause a rise in blood pressure.
Maltese: • inibituri ta' monoamine oxidase (MAOIs - monoaminoxidase inhibitors), inklużi mediċini bi kwalitajiet simili bħal furazolidone u procarbazine, użati biex jittrattaw disturbi mentali, jistgħu jikkawżaw żieda fil-pressjoni tad-demm.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (MULTIPACK ONLY: no Blue Box is included)
Maltese: KARTUNA TA' BARRA INTERMEDJA (PAKKETT B'ĦAFNA BISS: mhux inkluża Kaxxa
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Riarify reduced the rate of moderate/severe exacerbations over 52 weeks by 23% (rate: 0.41 versus 0.53 events per patient/year; p = 0.005).
Maltese: Meta mqabbel ma' kombinazzjoni fissa ta' beclometasone dipropionate u formoterol, Riarify naqqas ir-rata ta' episodji ta' aggravar moderat/sever fuq medda ta' 52 ġimgħa bi 23% (rata: 0.41 kontra 0.53 avveniment għal kull pazjent/sena; p = 0.005).
English: In addition, compared with both a fixed combination of beclometasone dipropionate and formoterol and with tiotropium, Riarify significantly prolonged the time to first exacerbation (hazard ratio 0.80 and 0.84 respectively; p = 0.020 and 0.015 respectively), with no differences between Riarify and the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (hazard ratio 1.06).
Maltese: Barra dan, meta mqabbel kemm ma' kombinazzjoni fissa ta' beclometasone dipropionate u formoterol kif ukoll ma' tiotropium, Riarify tawwal b'mod sinifikanti ż-żmien sal-ewwel episodju ta' aggravar (proporzjon ta' periklu 0.80 u 0.84 rispettivament; p = 0.020 u 0.015 rispettivament), bl-ebda differenzi bejn Riarify u l-kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' beclometasone dipropionate u formoterol flimkien ma' tiotropium (proporzjon ta' periklu 1.06).