FrancophonIA/ELRC3.0 huggingface dataset:
English: • Patients should note that symptoms of hepatitis can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage), sometimes with a loss of appetite.
Maltese: • Il-pazjenti għandhom jinnotaw li s-sintomi tal-epatite jistgħu jinkludu sfurija fil-ġilda u fl-għajnejn, ħakk, awrina skura, uġigħ fl-istonku u sensittività fil-fwied (indikata minn uġigħ taħt in-naħa ta' quddiem tal-kustilji), xi drabi b'nuqqas ta' aptit.
English: There were 9 reports of liver failure in people using Alli since it was marketed in May 2007 until January 2011, although in some cases there were other possible explanations and in some cases there was insufficient information to assess the cause.
Maltese: Kien hemm disa' rapporti ta' insuffiċjenza tal-fwied f'persuni li użaw Alli sa minn meta tqiegħed fis-suq f'Mejju 2007 sa Jannar 2011, għalkemm f'ċerti każi kien hemm spjegazzjonijiet oħrajn possibbli u f'ċerti każi ma kienx hemm biżżejjed informazzjoni sabiex tkun evalwata l-kawża.
English: It noted that the product information for Xenical already listed ‘hepatitis that may be serious' as a side effect of unknown frequency, and recommended that the product information for all orlistat-containing medicines should be harmonised to include this information.
Maltese: Innota li l-informazzjoni dwar il-prodott għal Xenical diġà ssemmi ‘epatite li tista' tkun serja' bħala effett sekondarju ta' frekwenza mhux magħrufa, u rrakkomanda li l-informazzjoni dwar il-prodott għallmediċini kollha li fihom l-orlistat għandha tkun armonizzata sabiex tinkludi din l-informazzjoni.
English: The CHMP reviewed the available data on the risk of liver injury and other side effects with orlistat, including post-marketing surveillance, data from the studies supporting the marketing authorisations and population-based studies in the published literature.
Maltese: Is-CHMP irreveda d-dejta disponibbli dwar ir-riskju ta' ħsara fil-fwied u effetti sekondarji oħrajn blorlistat, inkluża sorveljanza ta' wara t-tqegħid fis-suq, dejta mill-istudji li jappoġġjaw lawtorizzazzjonijiet għat-tqegħid fis-suq u studji bbażati fuq il-popolazzjoni fir-riċensjoni ppubblikata.
English: This risk has been closely monitored by the CHMP and measures to manage the known risks were put in place.
Maltese: Dan ir-riskju kien issorveljat mill-qrib mis-CHMP u ġew stabbiliti miżuri ta' ġestjoni tar-riskji magħrufa.
English: Overall, from 1997 to January 2011, 21 cases of severe liver toxicity were reported where Xenical was considered a possible cause, although other factors that could have caused the liver injury were present.
Maltese: Inġenerali, mill-1997 sa Jannar 2011, ġew irrapportati 21 każ ta' tossiċità severa tal-fwied fejn Xenical kien meqjus bħala kawża possibbli, għalkemm kien hemm fatturi oħrajn li setgħu kkawżaw il-ħsara fil-fwied.
English: When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about a quarter of the fat eaten in the meal to be passed out in the stools undigested.
Maltese: Meta dawn l-enzimi jiġu mblokkati, ma jkunux jistgħu jimmetabolizzaw ċerti xaħmijiet fl-ikel, u dan jippermetti li madwar kwart tax-xaħam li jittiekel fl-ikel jgħaddi fl-ippurgar mingħajr ma jkun metabolizzat.
English: The Committee also agreed on minor amendments to the package leaflet for all orlistat-containing medicines to ensure they give the same information, including a description of the symptoms of hepatitis to alert patients to these symptoms.
Maltese: Il-Kumitat qabel ukoll dwar emendi żgħar fil-fuljett ta' tagħrif għall-mediċini kollha li fihom l-orlistat sabiex ikun żgurat li jagħtu l-istess informazzjoni, inkluża deskrizzjoni tas-sintomi tal-epatite sabiex iwissu lill-pazjenti dwar dawn is-sintomi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of orlistat continue to outweigh its risks, and recommended that the marketing authorisations be maintained with minor amendments to the product information to ensure the same information on very rare liver-related side effects is provided for all orlistat-containing medicines.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem tal-Aġenzija (CHMP) ikkonkluda li l-benefiċċji tal-orlistat għadhom akbar mir-riskji tiegħu, u rrakkomanda li l-awtorizzazzjonijiet għat-tqegħid fis-suq jinżammu b'emendi żgħar flinformazzjoni dwar il-prodott sabiex ikun żgurat li tingħata l-istess informazzjoni għall-mediċini kollha li fihom l-orlistat dwar effetti sekondarji rari ħafna marbuta mal-fwied.
English: The Committee also reviewed information requested from the companies that market orlistat-containing medicines, including the estimated number of people using these medicines and an analysis of the observed number of reports of severe liver problems compared with the expected background rate of liver problems in these people.
Maltese: IlKumitat irreveda wkoll informazzjoni mitluba mingħand il-kumpaniji li jbiegħu l-mediċini li fihom lorlistat, inkluża stima tan-numru ta' persuni li jużaw dawn il-mediċini u analiżi tan-numru osservat ta' rapporti ta' problemi serji fil-fwied apparagun mar-rata ta' sfond ta' problemi tal-fwied mistennija f'dawn il-persuni.
English: (Invented) name Strength Pharmaceutical form Route of administration
Maltese: Invega 3 mg Pillola li terħi l-mediċina bilmod folja (OPA-Alu-PVC/Alu) 28 pillola
English: Pack size
Maltese: Ippakkjar
English: EU number
Maltese: Numru ta' lEU
English: In the pooled 6-month database the frequency of dry mouth was 2.2% versus 1.1%, of insomnia 1.0% versus 0.8%, and of gastroenteritis 1.4% versus 0.9%, for Enurev Breezhaler and placebo respectively.
Maltese: Fid-databażi miġbura tul is-6 xahar il-frekwenza ta' ħalq xott kienet ta' 2.2% kontra 1.1%, ta' nuqqas ta' rqad 1.0% kontra 0.8%, u ta' gastroenterite 1.4% kontra 0.9%, għal Enurev Breezhaler u plaċebo rispettivament.
English: Enurev Breezhaler 44 micrograms once daily provided consistently statistically significant improvement in lung function (forced expiratory volume in one second, FEV1, forced vital capacity, FVC, and inspiratory capacity, IC) in a number of clinical studies.
Maltese: 44 mikrogramma Enurev Breezhaler darba kuljum ipprovdew titjib statistikament sinifikanti konsistenti fil-funzjoni tal-pulmun (volum espiratorju sfurzat f'sekonda waħda, FEV1, kapaċità vitali sfurzata, FVC, u kapaċità ispiratorja, IC) f'għadd ta' studji kliniċi.
English: Enurev Breezhaler 44 mcg inhalation powder glycopyrronium
Maltese: Enurev Breezhaler 44 μg trab li jittieħed man-nifs glycopyrronium
English: In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Enurev Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Enurev Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
Maltese: Fl-istudju ta' 6 xhur, ilpersentaġġ ta' pazjenti li kellhom taħrix moderat jew sever kien ta' 17.5% għal Enurev Breezhaler u ta' 24.2% għall-plaċebo (Proporzjon ta' periklu: 0.69, p=0.023), u fl-istudju ta' 12-il xahar kien ta' 32.8% għall Enurev Breezhaler u ta' 40.2% għall-plaċebo (Proporzjon ta' periklu: 0.66, p=0.001).
English: Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (44 micrograms once daily) of Enurev Breezhaler and were well tolerated.
Maltese: L-ogħla livelli tal-plażma u l-espożizzjoni sistemika totali wara l-għoti ta' 150 mikrogramma glycopyrronimum bromide fil-vini (ekwivalenti għal 120 mikrogramma glycopyrronium) f'voluntiera b'saħħithom kienu ta' madwar 50 darba u 6 darbiet aktar mill-ogħla espożizzjoni u mill-espożizzjoni sħiħa fi stat fiss rispettivament miksuba mid-doża rrakkomandata (44 mikrogramma darba kuljum) ta' Enurev Breezhaler u kienu ttollerati sew.
English: Date of first authorisation: 28 September 2012 Date of latest renewal: 13 July 2017
Maltese: Data tal-aħħar tiġdid: 13 Lulju 2017
English: In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) Enurev Breezhaler can be used at the recommended dose.
Maltese: F'pazjenti b'COPD b'indeboliment tal-kliewi minn ħafif għal moderat (rata ta' filtrazzjoni glomerulari, eGFR taħt it-30 ml/min/1.73 m2) Enurev Breezhaler jista' jintuża skont id-doża rrakkomandata.
English: Enurev Breezhaler 44 micrograms inhalation powder, hard capsules glycopyrronium (as glycopyrronium bromide)
Maltese: Enurev Breezhaler 44 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa glycopyrronium (bħala glycopyrronium bromide)
English: Enurev Breezhaler administered at 44 micrograms once daily statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI).
Maltese: Enurev Breezhaler mogħti f'doża ta' 44 mikrogramma kuljum inaqqas b'mod statistikament sinifikanti l-episodji ta' qtugħ ta' nifs skont kif evalwat mill-Indiċi ta' Dispnea Tranżitorja (TDI).
English: Enurev Breezhaler once daily statistically significantly reduced the use of rescue medication (salbutamol) by 0.46 puffs per day (p=0.005) over 26 weeks and by 0.37 puffs per day (p=0.039) over 52 weeks, compared to placebo for the 6- and 12-month studies, respectively.
Maltese: Enurev Breezhaler darba kuljum naqqas b'mod statistikament sinifikanti l-użu ta' mediċini ta' salvataġġ (salbutamol) b'0.46 pumpjaturi kuljum (p=0.005) tul 26 ġimgħa u b'0.37 pumpjaturi kuljum (p=0.039) tul 52 ġimgħa, imqabbel mal-plaċebo tul l-istudji li damu 6 u 12-il xahar, rispettivament.
English: Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Enurev Breezhaler hu indikat bħala trattament bronkodilatatur ta' manutenzjoni biex iserraħ lil pazjenti adulti minn sintomi ta' mard pulmonari ostruttiv kroniku (COPD).
English: No specific side effects have been reported when Enurev Breezhaler has been used together with other medicines used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).
Maltese: Ma ġewx irrappurtati effetti sekondarji speċifiċi meta Enurev Breezhaler intuża flimkien ma' mediċini oħrajn użati biex jittrattaw COPD bħalma huma inalaturi ta' serħan (eż. salbutamol), methylxanthines (eż. theophylline) u/jew sterojdi orali u meħuda mal-imnfisejn (eż. prednisolone).
English: This includes medicines similar to Enurev Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).
Maltese: Dan jinkludi mediċini simili għal Enurev Breezhaler użati għall-mard li għandek tal-pulmun, bħal ipratropium, oxitropium jew tiotropium (imsejħa wkoll antikolinerġiċi).
English: Enurev Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8).
Maltese: Enurev Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti anzjani (minn 75 sena 'l fuq) (ara sezzjoni 4.8).
English: No change in mean heart rate or QTc interval was observed with Enurev Breezhaler in doses up to 176 micrograms in COPD patients.
Maltese: Ma kienx hemm bidla fir-rata tat-taħbit tal-qalb jew fl-intervall tal-QTc b'Enurev Breezhaler b'dożi sa 176 mikrogramma f'pazjenti b'COPD.
English: In clinical studies with Enurev Breezhaler, paradoxical bronchospasm was not observed.
Maltese: Fi studji kliniċi b'Enurev Breezhaler, ma kienx hemm spażmi paradossali tal-bronki.
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: Ir-rekwiżiti biex jiġu ppreżentatirapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Enurev Breezhaler contains lactose
Maltese: Enurev Breezhaler fih il-lactose
English: What Enurev Breezhaler contains - The active substance is glycopyrronium bromide.
Maltese: X'fih Enurev Breezhaler - Is-sustanza attiva hi glycopyrronium bromide.
English: Enurev Breezhaler 44 micrograms inhalation powder, hard capsules
Maltese: IL-PRODOTT MEDIĊINALI Enurev Breezhaler 44 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa
English: In the 6-month study, Enurev Breezhaler increased FEV1 after the first dose with an improvement of 93 ml within 5 minutes and 144 ml within 15 minutes of dosing, compared to placebo (both p<0.001).
Maltese: Fl-istudju li dam 6 xhur, Enurev Breezhaler żied l-FEV1 wara l-ewwel doża b'titjib ta' 93 ml fi żmien 5 minuti u ta' 144 ml fi żmien 15-il minuta mid-doża, imqabbel mal-plaċebo (it-tnejn p<0.001).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attivaelenkata fissezzjoni 6.1.
English: What Enurev Breezhaler looks like and contents of the pack Enurev Breeyhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder.
Maltese: Kif jidher Enurev Breezhaler u l-kontenut tal-pakkett Il-kapsuli iebsin ta' Enurev Breeyhaler 44 mikrogramma trab li jittieħed man-nifs, huma trasparenti u oranġjo u fihom trab abjad.
English: 6 or 10 Seebri Breezhaler capsules to be used in the inhaler
Maltese: 10 kapsuli Enurev Breezhaler biex jintużaw mal inhaler
English: In a pooled analysis of the 6and 12-month pivotal studies a statistically significantly higher percentage of patients receiving Enurev Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (58.4% and 46.4% respectively, p<0.001).
Maltese: Fl-analiżi miġbura taż-żewġ studji pivitali, dak ta' 6 xhur u l-ieħor ta' 12-il xahar, kien hemm perċentwali ogħla b'mod statistikament sinifikanti ta' pazjenti li qed jingħataw Enurev Breezhaler li rrispondew b'titjib ta' punt 1 jew aktar fl-iskor fokali ta' TDI fis-26 ġimgħa mqabbel mal-plaċebo (58.4% u 46.4% rispettivament, p<0.001).
English: Show the pack of Enurev Breezhaler.
Maltese: Uri l-pakkett ta' Enurev Breezhaler.
English: The long duration of action can be partly attributed to sustained concentrations of active substance in the lung as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the Enurev Breezhaler inhaler in contrast to the half life after intravenous administration (see section 5.2).
Maltese: Jista' jkun li parti mir-raġuni għala l-prodott mediċinali jibqa' jaħdem fit-tul hi minħabba lkonċentrazzjonijiet sostenibbli tas-sustanza attiva fil-pulmun kif jidher mill-eliminazzjoni terminali mtawla tal-half-life ta' glycopyrronium wara li jittieħed man-nifs bl-inhaler Enurev Breezhaler għallkuntrarju tal-half-life wara l-għoti mill-vina (ara sezzjoni 5.2).
English: At 12 weeks (primary endpoint), Enurev Breezhaler increased trough FEV1 by 72 ml in patients with the lowest degree of reversibility (<5%) and by 113 ml in those patients with a higher degree of reversibility at baseline (≥5%) compared to placebo (both p<0.05).
Maltese: Wara 12-il ġimgħa (punt ta' tmiem primarju), Enurev Breezhaler żied il-FEV1 minimu bi 72 ml fil-pazjenti bl-inqas livell ta' riversibbiltà (<5%) u b'113-il ml f'dawk il-pazjenti li kellhom grad ogħla ta' riversibbiltà fil-linja bażi (≥5%) meta mqabbel mal-plaċebo (it-tnejn p<0.05).
English: Other medicines and Enurev Breezhaler
Maltese: Mediċini oħra u Enurev Breezhaler
English: • One Seebri Breezhaler inhaler
Maltese: • Inhaler wieħed Enurev Breezhaler
English: The capsules must be administered only using the Enurev Breezhaler inhaler (see section 6.6).
Maltese: Il-kapsuli għandhom jittieħdu biss billi jintuża l-inhaler Enurev Breezhaler (ara sezzjoni 6.6).
English: Although no formal drug interaction studies have been performed, Enurev Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions.
Maltese: Minkejja li ma saru l-ebda studji formali dwar l-interazzjoni tal-mediċina, Enurev Breezhaler intuża flimkien ma' prodotti mediċinali oħrajn użati normalment waqt it-trattament ta' COPD mingħajr evidenza klinika ta' interazzjonijiet bejn il-mediċini.
English: In the 12-month study, Enurev Breezhaler produced statistically significant improvements in FEV1 compared to tiotropium in the first 4 hours after dosing on day 1 and at week 26, and numerically greater values for FEV1 in the first 4 hours after dosing than tiotropium at week 12 and week 52.
Maltese: Fl-istudju li dam 12-il ġimgħa, Enurev Breezhaler ipproduċa titjib sinjifikanti statistikament fl-FEV1, imqabbel ma' tiotropium fl-ewwel 4 sigħat mid-doża fl-ewwel jum u fis26 ġimgħa, u valuri numerikament akbar għal FEV1, fl-ewwel 4 sigħat mid-doża milli għal tiotropium fit-12-il ġimgħa u fit-52 ġimgħa.
English: In a pooled analysis of the first 6 months of treatment in the 6- and 12-month studies, compared to placebo Enurev Breezhaler statistically significantly prolonged time to first moderate or severe exacerbation and reduced the rate of moderate or severe COPD exacerbations (0.53 exacerbations/year versus 0.77exacerbations /year, p<0.001).
Maltese: F'analiżi miġbura tal-ewwel 6 xhur ta' kura fl-istudji ta' 6 xhur u 12-il xahar, imqabbel mal-plaċebo Enurev Breezhaler tawwal b'mod statistikament sinifikanti ż-żmien għall-ewwel taħrix ħafif jew gravi u naqqas ir-rata ta' taħrix moderat jew gravi ta' COPD (taħrix ta' 0.53 fis-sena kontra taħrix ta' 0.77 fis-sena, p<0.001).
English: In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Enurev Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Maltese: F'pazjenti b'indeboliment tal-kliewi gravi (rata ta' filtrazzjoni glomerulari stmata taħt it-30 ml/min/1.73 m2), inkluż dawk li jinsabu fl-aħħar stadju talmarda tagħhom tal-kliewi u li jeħtieġu dijaliżi, Enurev Breezhaler għandu jintuża biss jekk ilbenefiċċji mistennija jegħlbu r-riskju li jista' jkun hemm (ara sezzjoni 5.2).
English: Enurev Breezhaler also reduced dyspnoea at rest measured using the Transitional Dyspnoea Index.
Maltese: Enurev Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti b'indeboliment tal-kliewi bejn ħafif u moderat.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Enurev Breezhaler in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Enurev Breezhaler f'kull sett tal-popolazzjoni pedjatrika fil-COPD (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Enurev Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p<0.001).
Maltese: Fl-analiżi miġbura taż-żewġ studji pivitali, dak ta' 6 xhur u l-ieħor ta' 12-il xahar, instab li kien hemm perċentwali ogħla b'mod statistikament sinifikanti ta' pazjenti li qed jingħataw Enurev Breezhaler li rrispondew b'titjib ta' punt 4 jew aktar f'SGRQ fis-26 ġimgħa mqabbel mal-plaċebo (57.8% u 47.
English: In patients with severe renal impairment (eGFR <30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Enurev Breezhaler should only be used if the expected benefit outweighs the potential risk (see section 4.4).
Maltese: F'pazjenti b'indeboliment tal-kliewi gravi (eGFR <30 ml/min/1.73 m2), inkluż dawk li jinsabu fl-aħħar stadju tal-marda tagħhom tal-kliewi u li jeħtieġu dijaliżi, Enurev Breezhaler għandu jintuża biss jekk il-benefiċċji mistennija jegħlbu r-riskju li jista' jkun hemm (ara sezzjoni 4.4).
English: Enurev Breezhaler 44 micrograms once daily can be safely used in all age and body weight groups.
Maltese: 44 mikrogramma Enurev Breezhaler darba kuljum jistgħu jintużaw bla periklu minn nies ta' kull età u piż.
English: At 12 weeks (primary endpoint), Enurev Breezhaler increased trough FEV1 by 108 ml in the 6-month study and by 97 ml in the 12-month study compared to placebo (both p<0.001).
Maltese: Fit-12-il ġimgħa (l-endpoint primarju), Enurev Breezhaler żied l-FEV1 b'108 ml fl-istudju li dam 6 xhur u b'97 ml fl-istudju li dam 12-il xahar imqabbel mal-plaċebo (it-tnejn p<0.001).
English: Enurev Breezhaler is a once-daily, long-term maintenance treatment and is not indicated for the initial treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Maltese: Enurev Breezhaler hu trattament ta' manutenzjoni fit-tul, biex jintuża darba kuljum u mhux indikat biex jintuża bħala trattament inizjali ta' episodji akuti ta' spażmi tal-bronki, jiġifieri bħala terapija ta' salvataġġ.
English: Skin and subcutaneous tissue disorders Rash
Maltese: Disturbi fis-sistema nervuża Uġigħ ta' ras3)
English: The pooled analysis also showed fewer patients treated with Enurev Breezhaler than with placebo experienced an exacerbation requiring hospitalisation (1.7% versus 4.2%, p=0.003).
Maltese: L-analiżi miġbura wriet ukoll li kien hemm anqas pazjenti kkurati b'Enurev Breezhaler milli dawk bi plaċebo li kellhom taħrix u li kienu jeħtieġu kura l-isptar (1.7% kontra 4.2%, p=0.003).
English: Acute intoxication by inadvertent oral ingestion of Enurev Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%).
Maltese: Mhux mistenni li jkun hemm effett tossiku gravi meta l-kapsuli Enurev Breezhaler jinbelgħu bi żball mill-ħalq minħabba l-bijodisponibbiltà orali baxxa (madwar 5%).
English: Infections and infestations Nasopharyngitis1)
Maltese: Infezzjonijiet u infestazzjonijiet Nażofarinġite
English: After three weeks of treatment the improvement in inspiratory capacity with Enurev Breezhaler was similar to the first day (200 ml), exercise endurance time however had increased by 89 seconds (an increase of 21%) compared to placebo.
Maltese: Wara tliet ġimgħat ta' trattament it-titjib fil-kapaċità ispiratorja b'Enurev Breezhaler kien jixbah lil dak fl-ewwel ġurnata (200 ml), madanakollu kien hemm żieda ta' 89 sekonda (żieda ta' 21%) fl-ammont ta' ħin li wieħed jiflaħ għall-eżerċizzju mqabbel mal-plaċebo.
English: • Do not use the Enurev Breezhaler capsules with any other inhaler.
Maltese: • Tużax il-kapsuli Enurev Breezhaler ma' xi inhaler ieħor.
English: • Runny or stuffy nose, sneezing, sore throat
Maltese: • Diffikultà u wġigħ meta tgħaddi l-awrina