FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC concluded that in view of the currently available safety data in order to maintain a favourable benefit-risk as parenteral nutrition in term newborn infants and children up to 2 years when oral or enteral nutrition is not possible, insufficient or contraindicated, additional warnings on the risk of hypermagnesemia should be introduced in the Product Information;
Maltese: • Il-PRAC ikkonkluda li fid-dawl tad-dejta disponibbli fil-preżent dwar is-sigurtà sabiex jinżamm benefiċċju-riskju favorevoli bħala nutrizzjoni parenterali fi trabi tat-twelid li jitwieldu wara 37 ġimgħa ta' ġestazzjoni u fi tfal sa sentejn meta n-nutrizzjoni orali jew enterali ma tkunx possibbli, biżżejjed jew tkun kontraindikata, twissijiet addizzjonali dwar ir-riskju ta' ipermagnesimja għandhom jiġu introdotti fl-Informazzjoni dwar il-Prodott;
English: Overall Numeta was found to be acceptable to paediatric clinical staff in terms of handling, ease of use and time from prescription to infusion.
Maltese: Numeta nstab li kien aċċettabbli għall-persunal pedjatriku kliniku f'termini ta' immaniġġjar, faċilità ta' użu u żmien mill-preskrizzjoni sal-infużjoni.
English: Laparoscopic / minimally invasive procedures
Maltese: Proċeduri laparoskopiċi/ minimament invażivi
English: Duplospray MIS Regulator NIST B11
Maltese: Regolatur Duplospray MIS NIST B11
English: 10 - 15 cm
Maltese: 10 - 15 ċm
English: Duplospray MIS Regulator
Maltese: Duplospray MIS Regolatur
English: 10-15cm
Maltese: 10-15ċm
English: In minimally invasive/laparoscopic procedures - a pressure regulator device that delivers a maximum pressure of no more than 1.5 bar (22 psi) and uses carbon dioxide gas only should be used.
Maltese: Fi proċeduri laparoskopiċi/minimament invażivi - tagħmir b'regolatur tal-pressjoni li jforni pressjoni massima ta' mhux iktar minn 1.5 bar (22 psi) u juża biss gass tal-carbon dioxide għandu jintuża.
English: Tisseel / Tissucol Spray Set
Maltese: Sett tal-Isprej Tisseel/Tissucol
English: • “[PRODUCT NAME] should not be used in laparoscopic surgery (keyhole surgery).
Maltese: • “[PRODUCT NAME] m'għandux jintuża f'operazzjoni laparoskopika (operazzjoni tat-tip keyhole).
English: 2 - 5 cm 1.2-1.5 bar (18-22 psi)
Maltese: 2 - 5 ċm 1.2-1.5 bar (18-22 psi)
English: Open wound
Maltese: Ferita miftuħa
English: Tisseel / Artiss Spray Set 10 pack
Maltese: Sett tal-Isprej Tisseel/Artiss 10 pakketti
English: Duplospray MIS
Maltese: Regolatur Duplospray MIS
English: 10-15cm 1.5-2.0 bar (21.5-28.5 psi).
Maltese: 10-15ċm 1.5-2.0 bar (21.5-28.5 psi).
English: “Apply [PRODUCT NAME] as a thin layer.
Maltese: “Applika [PRODUCT NAME] bħala saff irqiq.
English: For spray application, see sections 4.4 and 6.6 for specific recommendations on the required pressure and distance from tissue per surgical procedure and length of applicator tips.”
Maltese: Għall-applikazzjoni tal-isprej, ara sezzjonijiet 4.4 u 6.6 għal rakkomandazzjonijiet speċifiċi dwar il-pressjoni u d-distanza meħtieġa mit-tessut skont il-proċedura kirurġika u t-tul tat-trufijiet tal-applikatur.
English: Recommended pressure, distance and devices for spray application of [product name] Spray set to be used
Maltese: Pressjoni, distanza u tagħmir irrakkomandati għal applikazzjoni tal-isprej ta' [product name]
English: In order to ensure optimal safe use of [PRODUCT NAME] it should be sprayed using a pressure regulator device that delivers a maximum pressure of up to 2.0 bar (28.5 psi).
Maltese: Sabiex tiżgura l-aħjar użu sigur ta' [PRODUCT NAME], dan għandu jiġi sprejjat billi tuża tagħmir b'regolatur tal-pressjoni li jforni pressjoni massima ta' sa 2.0 bar (28.5 psi).
English: Beriplast P and associated names
Maltese: Beriplast P (u ismijiet assoċjati)
English: Take special care with [PRODUCT NAME]
Maltese: Oqgħod attent ħafna bi [PRODUCT NAME]
English: When applying [PRODUCT NAME] using a spray device, be sure to use a pressure within the pressure range recommended by the spray device manufacturer (see table in section 6.6 for pressures and distances).
Maltese: Meta tapplika [PRODUCT NAME] billi tuża tagħmir tal-isprej, kun ċert li tuża pressjoni li tkun fil-medda tal-pressjoni rrakkomandata mill-manifattur tat-tagħmir tal-isprej (ara t-tabella f'sezzjoni 6.6 għal pressjonijiet u distanzi).
English: Tisseel / Artiss Spray Set
Maltese: Sett tal-Isprej Tisseel/Artiss
English: Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.
Maltese: Ħxuna eċċessiva tal-embolu tista' tinterferixxi b'mod negattiv mal-effikaċja tal-prodott u mal-proċess ta' fejqan tal-ferita.
English: [PRODUCT NAME] is not recommended for laparoscopic surgery.
Maltese: [PRODUCT NAME] mhuwiex irrakkomandat għal operazzjoni laparoskopika.
English: Recommen ded distance from target tissue
Maltese: Distanza rakkomandata mit-tessut fil-mira
English: Open wound surgery of subcutaneou s tissue
Maltese: Kirurġija Sett tal-isprej li jrid jintuża
English: • When spraying [PRODUCT NAME], changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored for possible occurrence of gas embolism.
Maltese: • Meta tisprejja [PRODUCT NAME], it-tibdil fil-pressjoni tad-demm, il-polz, is-saturazzjoni tal-ossiġnu u l-end tidal CO2 għandhom jiġu mmonitorjati għall-okkorrenza possibbli ta' emboliżmu tal-gass.
English: When spraying the [PRODUCT NAME], changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism (see sections 4.2 and 4.4).”
Maltese: Meta tisprejja l-[PRODUCT NAME], it-tibdil fil-pressjoni tad-demm, il-polz, is-saturazzjoni tal-ossiġnu u l-end tidal CO2 għandhom jiġu mmonitorjati minħabba l-possibbilità tal-okkorrenza ta' emboliżmu tal-arja jew tal-gass (ara sezzjonijiet 4.2 u 4.4).”
English: The risk appears to be higher when fibrin sealants are sprayed with air, as compared to CO2 and therefore cannot be excluded with [Product Name] when sprayed in open wound surgery.
Maltese: Ir-riskju jidher li hu ogħla meta siġillanti ta' fibrin jiġu sprejjati mal-arja, meta mqabbla ma' CO2 u għalhekk ma jistax jiġi eskluż ma' [Product Name] meta sprejjat f'operazzjoni fuq ferita miftuħa.
English: • “Life-threatening/fatal air or gas embolism (air getting into the blood circulation which can be serious or life-threatening) has occurred very rarely with the use of spray devices employing pressure regulators to administer fibrin sealants.
Maltese: • “Emboliżmu tal-arja jew tal-gass fatali/ta' periklu għall-ħajja (arja li tidħol fiċ-ċirkolazzjoni tad-demm li tista' tkun serja jew ta' periklu għall-ħajja) seħħ b'mod rari ħafna bl-użu ta' tagħmir tal-isprej li juża regolaturi tal-pressjoni biex jingħataw siġillanti ta' fibrin.
English: The risk appears to be higher when fibrin sealants are sprayed with air, as compared to CO2 and therefore cannot be excluded with [Product Name].
Maltese: Ir-riskju jidher li hu ogħla meta siġillanti ta' fibrin jiġu sprejjati mal-arja, meta mqabbla ma' CO2 u għalhekk ma jistax jiġi eskluż ma' [Product Name].
English: Recommend ed distance from target tissue
Maltese: Distanza rakkomandat a mit-tessut fil-mira
English: Life-threatening/fatal air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealants.
Maltese: Emboliżmu tal-arja jew tal-gass ta' periklu għall-ħajja/fatali seħħ bl-użu ta' tagħmir tal-isprej li juża regolatur tal-pressjoni biex jingħataw siġillanti ta' fibrin.
English: • Life-threatening/fatal air or gas embolism (air getting into the blood circulation which can be serious or life-threatening) has occurred very rarely with the use of spray devices employing pressure regulators to administer fibrin sealants.
Maltese: • Emboliżmu tal-arja jew tal-gass fatali/ta' periklu għall-ħajja (arja li tidħol fiċ-ċirkolazzjoni tad-demm li tista' tkun serja jew ta' periklu għall-ħajja) seħħ b'mod rari ħafna bl-użu ta' tagħmir tal-isprej li juża regolaturi tal-pressjoni biex jingħataw siġillanti ta' fibrin.
English: When applying [PRODUCT NAME] using a spray device be sure to use a pressure and a distance from the tissue within the range recommended by the manufacturer as follows:
Maltese: Meta tapplika [PRODUCT NAME] billi tuża tagħmir tal-isprej, kun ċert li tuża pressjoni u distanza mit-tessut li jkunu fil-medda rakkomandata mill-manifattur kif ġej:
English: In open wound surgery - a pressure regulator device that delivers a maximum pressure of no more than 2.0 bar (28.5 psi) should be used.
Maltese: F'operazzjoni ta' ferita miftuħa - għandu jintuża tagħmir b'regolatur tal-pressjoni li jforni pressjoni massima ta' mhux iktar minn 2.0 bar (28.5 psi).
English: “When applying [PRODUCT NAME] using a spray device be sure to use a pressure and a distance from tissue within the ranges recommended by the manufacturer as follows:
Maltese: “Meta tapplika [PRODUCT NAME] billi tuża tagħmir tal-isprej, kun ċert li tuża pressjoni u distanza mit-tessut li jkunu fil-meded irrakkomandati mill-manifattur kif ġej:
English: Prior to applying [PRODUCT NAME] the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Maltese: Qabel ma tapplika [PRODUCT NAME], l-erja tas-superfiċje tal-ferita jeħtieġ li titnixxef permezz ta' proċeduri standard (eż. applikazzjoni intermittenti ta' kompressi, swabs, l-użu ta' tagħmir li jiġbed).
English: When spraying [PRODUCT NAME], changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism (also see section 4.2).”
Maltese: Meta tisprejja [PRODUCT NAME], it-tibdil fil-pressjoni tad-demm, il-polz, is-saturazzjoni tal-ossiġnu u l-end tidal CO2 għandhom jiġu mmonitorjati minħabba l-possibbilità tal-okkorrenza ta' emboliżmu tal-arja jew tal-gass (ara wkoll sezzjoni 4.2).”
English: The following text should be inserted in this section: “Prior to applying [PRODUCT NAME] the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Maltese: Il-kitba li jmiss għandha tiddaħħal f'din is-sezzjoni: “Qabel ma tapplika [PRODUCT NAME], l-erja tas-superfiċje tal-ferita jeħtieġ li titnixxef permezz ta' proċeduri standard (eż. applikazzjoni intermittenti ta' kompressi, swabs, l-użu ta' tagħmir li jiġbed).
English: Applicator tips to be used
Maltese: Applikazzjoni tal-isprej
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Maltese: ANNESS III EMENDI GĦAS-SEZZJONIJIET RILEVANTI
English: When spraying the [PRODUCT NAME], changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism (see section 2).”
Maltese: Meta tisprejja l-[PRODUCT NAME], it-tibdil fil-pressjoni tad-demm, il-polz, is-saturazzjoni tal-ossiġnu u l-end tidal CO2 għandhom jiġu mmonitorjati minħabba l-possibbilità tal-okkorrenza ta' emboliżmu tal-arja jew tal-gass (ara sezzjoni 2).
English: Life-threatening air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealants.
Maltese: Emboliżmu tal-arja jew tal-gass ta' periklu għall-ħajja seħħ bl-użu ta' tagħmir tal-isprej li juża regolatur tal-pressjoni biex jingħataw siġillanti ta' fibrin.
English: Date of latest renewal: 26 July 2018
Maltese: Data ta' l-aħħar tiġdid: 26 ta 'Lulju 2018
English: INFORMATION IN BRAILLE revinty ellipta 92:22
Maltese: Revinty Ellipta 92:22
English: - The other ingredients are lactose monohydrate (See section 2) and magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma lactose monohydrate(Ara t-taqsima 2) u magnesium stearate.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 02 ta' Mejju 2014
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li għandha l-identifikatur uniku inkluż.
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations), Harmire Road,
Maltese: Glaxo Operations UK Ltd (li tinnegozja bħala Glaxo Wellcome Operations), Harmire Road,
English: In a placebo-controlled study (SUMMIT) in subjects with moderate COPD (mean percent postbronchodilator screening FEV1 of 60%, SD 6%), and a history of, or an increased risk of cardiovascular disease, the incidence of pneumonia with FF/VI, FF, VI and placebo was: adverse events (6%, 5%, 4%, 5%); serious adverse events (3%, 4%, 3%, 3%); adjudicated on treatment deaths due to pneumonia (0.3%, 0.2%, 0.1%, 0.2%); the exposure adjusted rates (per 1000 treatment years) were: adverse events (39.5, 42.4, 27.7, 38.4); serious adverse events (22.4, 25.1, 16.4, 22.2); adjudicated on-treatment deaths due to pneumonia (1.8, 1.5, 0.9, 1.4) respectively.
Maltese: Fi studju kkontrollat bi plaċebo (SUMMIT) f'individwi b'COPD moderata (skrinjar wara l-bronkodilatur perċentwali medju FEV1 ta' 60%, SD 6%), u bi storja ta', jew b'riskju akbar ta' mard kardjovaskulari, linċidenza tal-pulmonite ma' FF/VI, FF, VI u plaċebo kienet: avvenimenti avversi (6%, 5%, 4%, 5%); avvenimenti avversi serji (3%, 4%, 3%, 3%); imwiet aġġudikati waqt il-kura minħabba l-pulmonite (0.3%, 0.2%, 0.1%, 0.2%); ir-rati aġġustati għall-esponiment (għal kull 1000 sena ta' kura) kienu: avvenimenti avversi (39.5, 42.4, 27.7, 38.4); avvenimenti avversi serji (22.4, 25.1, 16.4, 22.2); imwiet aġġudikati waqt ilkura minħabba l-pulmonite (1.8, 1.5, 0.9, 1.4) rispettivament.
English: Subjects randomised to once-daily FF/VI maintained lung function comparable with those randomised to twice-daily salmeterol/FP [difference in trough FEV1 of +19 mL (95% CI: -11, 49)].
Maltese: Il pazjenti randomisedgħal FF/VI darba kuljum żammew funzjoni tal-pulmun komparabbli ma' dawk li ġew randomisedgħal salmeterol/FP darbtejn kuljum [differenza fl-FEV1 minimu ta' +19 mL (95% CI: -11, 49)].
English: Revinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
Maltese: Revinty Ellipta hu indikat għat-trattament sintomatiku ta' persuni adulti b'COPD b'FEV1 ta' <70% imbassar normali (wara bronkodilatur) bi storja ta' taħrix minkejja terapija regolari bi bronkodilatur.
English: The pharmacologic effects of beta2-adrenoceptor agonist active substances, including vilanterol trifenatate, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP).
Maltese: L-effetti farmakoloġiċi tas-sustanzi attivi agonisti tal-adrenoriċetturi beta2, inkluż vilanterol trifenatate, huma tal-anqas parzjalment attribwibbli lill-istimulazzjoni tal-adenylate cyclase ġoċ-ċelloli, l-enzima li tikkatalizza l-konverżjoni ta' adenosine triphosphate (ATP) fi 3',5'-adenosine monophosphate ċikliku (AMP ċikliku).
English: BIAL, Portela & Ca. SA. Tel: + 351 22 986 61 00 info@bial.com
Maltese: Tel: + 351 22 986 61 00 info@bial.com
English: Two different strengths of Revinty Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.
Maltese: Huma disponibbli żewġ qawwiet differenti ta' Revinty Ellipta: fluticasone furoate 92 mikrogramma/vilanterol 22 mikrogramma u fluticasone furoate 184 mikrogramma/vilanterol 22 mikrogramma.
English: INFORMATION IN BRAILLE revinty ellipta 184:22
Maltese: Revinty Ellipta 184:
English: The adjusted mean treatment difference of -37 mL between the groups was not statistically significant (p=0.162).
Maltese: Id-differenza medja aġġustata tal-kuri, ta' 37 mL, bejn il-gruppi ma kinitx statistikament sinifikanti (p=0.162).
English: Asthma Revinty Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:
Maltese: Revinty Ellipta hu indikat għat-trattament regolari tal-ażżma f'persuni adulti u adolexxenti minn 12-il sena 'l fuq fejn l-użu ta' prodott mediċinali kombinat (agonisti beta2 li jaħdmu fit-tul u kortikosterojd li jittieħed man-nifs) ikun adattat:
English: Revinty Ellipta contains two active substances: fluticasone furoate and vilanterol.
Maltese: Revinty Ellipta fih żewġ sustanzi attivi: fluticasone furoate u vilanterol.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal mediċini.
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Maltese: M'hemm ebda evidenza klinika konklużiva għal differenzi bejn klassi u oħra fid-daqs tar-riskju talpulmonite fost prodotti kortikosterojdi li jittieħdu man-nifs.
English: A randomised, double-blind, parallel group, 24 week study (201378) was conducted to demonstrate noninferiority (using a margin of -100 mL for trough FEV1) of fluticasone furoate/vilanterol 92/22 once daily to salmeterol/FP 50/250 twice daily in adults and adolescents whose asthma was well controlled following 4 weeks of treatment with open-label salmeterol/FP 50/250 twice daily (N=1504).
Maltese: Sar studju randomised, double-blind, ta' grupp parallel, ta' 24 ġimgħa (201378) biex jintwera n-nuqqas ta' inferjorità (bl-użu ta' marġini ta' -100 mL għall-FEV1 minimu) ta' fluticasone furoate/vilanterol 92/22 darba kuljum għal salmeterol/FP 50/250 darbtejn kuljum fl-adulti u fl-adolexxenti li l-ażżma tagħhom kienet ikkontrollata tajjeb wara 4 ġimgħat ta' kura b'salmeterol/FP 50/250 open-label darbtejn kuljum (N=1504).
English: Following repeat dosing of fluticasone furoate/vilanterol for 7 days, there was an increase in fluticasone furoate systemic exposure (up to three-fold as measured by AUC(0-24)) in subjects with hepatic impairment (Child-Pugh A, B or C) compared with healthy subjects.
Maltese: Wara għoti ripetut ta' fluticasone furoate/vilanterol għal 7 ijiem, kien hemm żieda fl-esponiment sistemiku għal fluticasone furoate (sa tliet darbiet aktar kif imkejjel mill-AUC(0-24)) f'individwi b'indeboliment tal fwied (Child-Pugh A, B jew C) meta mqabbel ma' individwi b'saħħithom.
English: How to use Revinty Ellipta 4.
Maltese: Kif għandek tuża Revinty Ellipta 4.
English: Other medicines and Revinty Ellipta
Maltese: Mediċini oħra u Revinty Ellipta
English: Multipacks contain 3 x 30 dose inhalers.
Maltese: Il-pakketti multipli fihom 3 Inalaturi ta' 30 doża kull wieħed.
English: long-acting beta2-adrenergic agonists, such as salmeterol
Maltese: L-effetti farmakoloġiċi tas-sustanzi attivi agonisti tal-adrenoriċetturi beta2, inkluż vilanterol trifenatate,
English: Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including Revinty Ellipta.
Maltese: Jistgħu jidhru effetti kardjovaskulari, bħal arritmiji tal-qalb, eż. takikardija sopraventrikolari u extrasistoli, bi prodotti mediċinali simpatomimetiċi fosthom Revinty Ellipta.
English: The step-by-step instructions shown below for the 30-dose Ellipta inhaler (30 day supply) also apply to the 14-dose Ellipta inhaler (14 day supply).
Maltese: L-istruzzjonijiet pass pass murija hawn taħt għall-inalatur Ellipta ta '30 doża (provvista ta' 30 ġurnata) japplikaw ukoll għad-doża Ellipta inalatur ta' 14-il darba (provvista ta' 14-il ġurnata).
English: The maximum recommended dose is Revinty Ellipta 184/22 micrograms once daily.
Maltese: Id-doża massima rakkomandata hi Revinty Ellipta 184/22 mikrogramma darba kuljum.
English: EU/1/14/929/004 EU/1/14/929/005
Maltese: EU/1/14/929/001 EU/1/14/929/002 EU/1/14/929/003
English: For trough FEV1 subjects in the fluticasone furoate/vilanterol group achieved a LS mean change from baseline of 281 mL and subjects in the salmeterol/FP group a change of 300 mL; (the difference in adjusted mean of -19 mL (95%CI:-0.073, 0.034) was not statistically significant (p=0.485).
Maltese: Għall-FEV1 minimu, il-pazjenti fil-grupp li ngħata fluticasone furoate/vilanterol kisbu bidla medja fil-LS mil-linja bażi ta' 281 mL u l-pazjenti fil-grupp li ngħata salmeterol/FP kisbu bidla ta' 300 mL; (id-differenza fil-medja aġġustata ta' 19 mL (95%CI:-0.073, 0.034) ma kinitx statistikament sinifikanti (p=0.485).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 92/22 micrograms
Maltese: TIKKETTA TAL-PAKKETT (BIL-KAXXA L-BLU- PAKEKTT MULTIPLU) 92/22 mikrogramma
English: One inhalation of Revinty Ellipta 92/22 micrograms once daily.
Maltese: Revinty Ellipta 92/22 µg
English: Pharmacotherapeutic group: Drugs for obstructive airways diseases, adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics, ATC code: R03AK10.
Maltese: Mediċini għal mard ostruttiv tal-passaġġi tal-arja, adrenerġiċi flimkien ma' kortikosterojdi jew mediċini oħra, esklużi antikolinerġiċi,Kodiċi ATC:
English: In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of pneumonia per 1000 patient years was 18.4 for FF/VI 184/22 versus 9.6 for FF/VI 92/22 and 8.0 in the placebo group.
Maltese: F'analiżi integrata ta' 11-il studju dwar l-ażma (7,034 pazjent), l-inċidenza ta' pulmonite għal kull 1000 sena tal-pazjent kienet 18.4 għal FF/VI 184/22 kontra 9.6 għal FF/VI 92/22 u 8.0 fil-grupp tal-plaċebo. **Ksur
English: Revinty Ellipta contains lactose
Maltese: Kif jidher Revinty Ellipta u l-kontenut tal-pakkett
English: Prescribers should be aware that in patients with asthma, fluticasone furoate (FF) 100 micrograms once daily is approximately equivalent to fluticasone propionate (FP) 250 micrograms twice daily, while FF 200 micrograms once daily is approximately equivalent to FP 500 micrograms twice daily.
Maltese: Min jordnah għandu jkun konxju li f'pazjenti bl-ażma, fluticasone furoate (FF) 100 mikrogramma darba kuljum huwa bejn wieħed u ieħor ekwivalenti għal fluticasone propionate (FP) 250 mikrogramma darbtejn kuljum, filwaqt li FF 200 mikrogramma darba kuljum huma bejn wieħed u ieħor ekwivalenti għal FP 500 mikrogramma darbtejn kuljum.
English: Influenza
Maltese: • influwenza
English: The 184/22 micrograms strength is not approved for the treatment of COPD.
Maltese: Il-qawwa ta '184/22 mikrogramma mhix approvata għat-trattament tas-COPD.
English: Although there were more fractures in the Revinty Ellipta groups compared with the vilanterol 22 micrograms group, fractures typically associated with corticosteroid use (e.g., spinal compression/thoracolumbar vertebral fractures, hip and acetabular fractures) occurred in <1% of the Revinty Ellipta and vilanterol treatment arms.
Maltese: Għalkemm kien hemm aktar ksur fil gruppi li ħadu Revinty Ellipta meta mqabbel mal-grupp li ħa vilanterol 22 mikrogramma, ksur tipikament assoċjat mal-użu ta' kortikosterojdi (eż. kompressjoni spinali/ksur fil-partijiet toraċiċi u lombari tas-sinsla, ksur fil-ġenbejn u aċetubulari) seħħ f'<1% tal-gruppi li ngħataw Revinty Ellipta u vilanterol.
English: 1 inhaler of 14 doses 1 inhaler of 30 doses
Maltese: 3 x 30 doża Inalatur 1 ta' 14-il doża