FrancophonIA/ELRC3.0 huggingface dataset:
English: Haemoptysis has been commonly reported with Bronchitol in clinical studies.
Maltese: L-emoptisi ta' spiss ġiet irrapportata bi Bronchitol fi studji kliniċi.
English: In a study of 18 healthy male adult volunteers, the absolute bioavailability of mannitol powder for inhalation by comparison to mannitol administered intravenously was 0.59% ± 0.15.
Maltese: Fi studju fuq 18-il raġel voluntiera b'saħħithom, il-bijodisponibilità assoluta tat-trab mannitol għallinalazzjoni meta mqabbla ma' mannitol mogħti ġol-vina kienet ta' 0.59% ± 0.15.
English: In studies DPM-CF-301 and 302 relative % predicted FEV1 compared to control in children (6-11 years) was improved by 0.44% (95% CI -5.90, 6.77, N=43) and 6.1% (95% CI -1.28, 13.54, N=59) over 26 weeks (p=0.892 and 0.104) respectively.
Maltese: Fl-istudji DPM-CF-301 u 302 il-perċentaġġ relattiv tal-FEV1 previst meta mqabbel mal-kontroll fittfal (6-11-il sena) tjieb b'0.44% (95% CI -5.90, 6.77, N=43) u b'6.1% (95% CI -1.28, 13.54, N=59) fuq 26 ġimgħa (p=0.892 u 0.104) rispettivament.
English: Vomiting, Post-tussive vomiting Uncommon Nausea, Odynophagia, Retching
Maltese: Mhux komuni Nawseja, Odinofaġja, Tqalligħ
English: These figures for study DPM-CF-302 (N=305) are as follows: 65.24 (SD:13.90) and 64.35 (SD:15.29).
Maltese: Dawn il-figuri għall-istudju DPM-CF-302 (N=305) huma kif ġejjin: 65.24 (SD:13.90) u 64.35 (SD:15.
English: 2-week treatment pack of 280 hard capsules and 2 inhalers
Maltese: Pakkett ta' kura ta' ġimagħtejn ta' 280 kapsula iebsa u 2 inalaturi
English: Store below 30°C Store in the original blister in order to protect from moisture.
Maltese: Aħżen f'temperatura taħt 30°C Aħżen fil-folja oriġinali biex tilqa' mill-umdità.
English: Hyperresponsiveness to mannitol
Maltese: Rispons eċċessiv għal mannitol
English: Uncommon Pyrexia
Maltese: Mhux komuni Piressija
English: Bronchitol has not been studied in patients with a history of significant episodes of haemoptysis (>60 ml) in the previous three months.
Maltese: Bronchitol ma ġiex studjat f'pazjenti bi storja ta' episodji sinifikanti ta' emoptisi (>60 ml) fit-tliet xhur ta' qabel.
English: At the end of the initiation dose you will have taken 10 capsules (400 mg) which is the same as the usual dose.
Maltese: Fi tmiem id-doża inizjali, tkun ħadt 10 kapsuli (400 mg), l-istess ammont tad-doża normali.
English: One initiation dose pack of Bronchitol contains 1 blister with 10 capsules and 1 inhaler.
Maltese: Pakkett ta' doża tal-bidu waħda ta' Bronchitol fih 1 folja b'10 kapsuli u 1 inalatur.
English: The proportion of patients who experienced haemoptysis as an adverse reaction was 7.3%, 3.3% and 3.4% in the Bronchitol arms for studies 301, 302 and 303 respectively vs. 3.4%, 0% and 5.6% in the control arms.
Maltese: Ilproporzjon ta' pazjenti li esperjenzaw l-emoptisi bħala reazzjoni avversa kien ta' 7.3%, ta' 3.3% u 3.4% fil-fergħat ta' Bronchitol għall-istudji 301, 302 u 303, rispettivament imqabbla ma' 3.4%, 0% u 5.6% fil-fergħat ta' kontroll.
English: One 2-week treatment pack of Bronchitol contains 28 blisters with 10 capsules each (280 capsules in total) and 2 inhalers.
Maltese: Pakkett wieħed ta' kura ta' ġimagħtejn ta' Bronchitol fih 28 folja b'10 kapsuli kull waħda (280 kapsula b'kollox) u 2 inalaturi.
English: Three Phase 3, 26-week double blind, randomised, parallel arm, controlled, intervention studies (DPM-CF-301,DPM-CF-302 and DPM-CF-303) have been performed in which 324 (DPM-CF-301) and 318 (DPM-CF-302) patients aged 6 years and above were randomised in a 3:2 ratio to inhaled mannitol 400 mg twice daily or to control (inhaled mannitol 50 mg twice daily).
Maltese: Saru tliet studji ta' intervent fuq 26 ġimgħa, tal-Fażi 3, b'għamad doppju, randomizzati, b'fergħa parallela, ikkontrollati, (DPM-CF-301, DPM-CF-302 u DPM-CF-303) li fihom 324 (DPM-CF-301) u 318 (DPM-CF-302) pazjenti 'il fuq minn 6 snin ġew randomizzati f'proporzjon ta' 3:2 għal mannitol li jittieħed man-nifs 400 mg darbtejn kuljum jew għal kontroll (mannitol li jittieħed man-nifs 50 mg darbtejn kuljum).
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: It-tagħrif attwalment disponibbli huwa deskritt fis-sezzjonijiet 4.8, 5.1 u 5.2, iżda ma tista' tingħata l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: Impaired lung function
Maltese: Indeboliment tal-funzjoni tal-pulmun
English: Capsules contain powder for oral inhalation using the inhaler device enclosed.
Maltese: Il-kapsuli fihom trab għal inalazzjoni orali permezz tal-apparat inalatur inkluż.
English: In study 303 13.4% subjects in the mannitol arm and 13.6% in the control had a PDPE.
Maltese: Fl-istudju 303, 13.4% individiwi fil-fergħa ta' mannitol u 13.6% fil-kontroll kellhom PDPE.
English: Renal and urinary disorders Uncommon Urinary incontinence General disorders and administration site conditions
Maltese: Mhux komuni Inkontinenza urinarja
English: In the ITT population of an open label dose response study, DPM-CF-202, the mean (SD) percent change in FEV1 for the 400 mg dose was 8.75 (SD: 12.4) and -1.569 (SD: 9.0) for 40 mg dose (p <
Maltese: Fil-popolazzjoni ITT ta' studju b'tikketta miftuħa dwar ir-rispons tad-doża, DPM-CF-202, il-bidla perċentwali medja (SD) fl-FEV1 għad-doża ta' 400 mg kienet ta' 8.75 (SD: 12.4) u ta' -1.569 (SD: 9.0) għad-doża ta' 40 mg (p < 0.0001).
English: Therapeutic dose regimen(6 to 17 years of age)
Maltese: Doża tal-bidu (minn 6 sa 17-il sena)
English: The limited data available in adolescents aged 12 to 17 years indicate the pharmacokinetic parameters of inhaled mannitol are similar to the adult population.
Maltese: It-tagħrif limitat disponibbli f'adolexxenti minn 12 sa 17-il sena jindika li l-parametri farmakokinetiċi ta' mannitol li jittieħed man-nifs huma simili għal tal-popolazzjoni adulta.
English: Uncommon Decreased appetite, CF related diabetes, Dehydration
Maltese: Mhux komuni Tnaqqis fl-aptit, Dijabete relatata mas-CF, Deidratazzjoni
English: The mean terminal half-life in adults was approximately 4 to 5 hours from serum and approximately 3.66 hours from urine.
Maltese: Il-medja tal-half-life terminali fl-adulti kienet ta' madwar 4 sa 5 sigħat mis-serum u madwar 3.66 sigħat mill-awrina.
English: Bronchitol 40 mg inhalation powder, hard capsules
Maltese: Bronchitol 40 mg trab għall-inalazzjoni, kapsuli iebsin
English: Table 2: Frequency of adverse reactions with Bronchitol in the phase 3 studies (initiation dose assessment and/or treatment phase) - paediatric population (6 to 17 years of age) System organ class
Maltese: Tabella 2: Frekwenza ta' reazzjonijiet avversi bi Bronchitol fl-istudji ta' fażi 3 (valutazzjonitad-doża tal-bidu u/jew fażi tal-kura) - popolazzjoni pedjatrika (età ta' 6 sa 17-il sena).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Step 1: Patients baseline FEV1 and SpO2 is measured prior to the initiation dose Step 2: Patient inhales 40 mg (1x40 mg capsules) and SpO2 is monitored Step 3: Patient inhales 80 mg (2x40 mg capsules) and SpO2 is monitored Step 4: Patient inhales 120 mg (3x40 mg capsules), FEV1 is measured and SpO2 is monitored
Maltese: Il-pazjent jieħu 80 mg man-nifs (żewġ kapsuli x40 mg) u l-SpO2 jiġi mmonitorjat Pass 4: Il-pazjent jieħu 120 mg man-nifs (tliet kapsuli x40 mg), l-FEV1 jiġi mkejjel u l-SpO2 jiġi mmonitorjat
English: Twenty seven (7.1%) out of 378 patients who undertook the mannitol tolerance test (MTT) in study 301, 18 (5.3%) out of 341 patientsin study 302 and 25 (5.1%) out of 486 patients in Study 303 had a positive (MTT).
Maltese: Sebgħa u għoxrin minn 378 pazjent (7.1%) li għamlu t-test għat-tolleranza għal mannitol (MTT) flistudju 301, 18 minn 341 pazjent (5.3%) fl-istudju 302 u 25 minn 486 pazjent (5.1%) fl-Istudju 303 kellhom MTT pożittiv.
English: The proportion of patients who experienced haemoptysis including haemoptysis reported during exacerbation was 7.0% in the mannitol arm and 7.7% in the control arm (see section 4.4).
Maltese: Il-proporzjon ta' pazjenti li esperjenzaw emoptisi inkluża emoptisi rrappurtata waqt l-aggravar kien ta' 7.0% fil-fergħa ta' mannitol u ta' 7.7% fil-fergħa ta' kontroll (ara sezzjoni 4.4).
English: The cumulative amount of mannitol filtered into the urine over the 24 hour collection period was similar for inhaled (55%) and oral (54%) mannitol.
Maltese: L-ammont kumulattiv ta' mannitol filtrat fl-awrina matul il-perijodu ta' ġbir fuq 24 siegħa kien simili għal mannitol li jittieħed man-nifs (55%) u orali (54%).
English: Twenty seven (7.1%) out of 378 patients who undertook the mannitol tolerance test (MTT) in study 301, 18 (5.3) out of 341 patients in study 302 and 25 out of 486 patients (5.1%) in study 303 had a positive MTT defined as either 1) a fall in FEV1 >20% from baseline at midpoint (step 4) or 2) fall from baseline > 20 % at end of test that did not recover to < 20% within 15 minutes or 3) who had a fall in FEV1 > 50% from baseline at end of test (step 6) or 4) who had a fall in Sp02 to < 89% during the procedure.
Maltese: Seba' u għoxrin (7.1%) minn 378 pazjent li għamlu t-test għat-tolleranza għal mannitol (MTT) fl-istudju 301, 18 (5.3%) minn 341 pazjent fl-istudju 302 u 25 minn 486 pazjent (5.1%) fl-istudju 303 kellhom MTT pożittiv definit jew bħala (1) tnaqqis fl-FEV1 >20% mil-linja bażi fil-punt tan-nofs (pass 4); jew (2) tnaqqis mil-linja bażi > 20 % fl-aħħar tat-test li ma rkuprax għal < 20% sa 15-il minuta; jew (3) li kellhom tnaqqis fl-FEV1 > 50% mil-linja bażi fl-aħħar tat-test (pass 6); jew (4) li kellhom tnaqqis flSp02 għal < 89% matul il-proċedura.
English: Non-CF Bronchiectasis
Maltese: Kif taħżen Bronchitol
English: - Put the capsule into the capsule-shaped space in the bottom of the inhaler.
Maltese: - Poġġi l-kapsula fl-ispazju forma ta' kapsula fil-qiegħ tal-inalatur.
English: Uncommon Bronchitis, Bronchopneumonia, Dysphonia, Hyperventilation, Sputum Discoloured, Throat irritation, Pharyngitis, Upper respiratory tract infection, Bronchospasm, Dyspnoea, Chest pain
Maltese: Mhux komuni Bronkite, Bronkopnewmonja, Disfonja, Iperventilazzjoni, Sputum skulurit, Irritazzjoni fil-ġriżmejn, Farinġite, Infezzjoni fil-passaġġ respiratorju ta' fuq, Bronkospażmu, Dispneja, Uġigħ fis-sider
English: A small percentage of systemically absorbed mannitol undergoes hepatic metabolism to glycogen and carbon dioxide.
Maltese: Perċentwal żgħir ta' mannitol li jiġi assorbit b'mod sistematiku jgħaddi minn metaboliżmu epatiku għal glajkoġen u dijossidu tal-karbonju.
English: In adolescents (12-17 years) relative change in % predicted FEV1 compared to control improved by 3.31% (95% CI -2.29, 8.90, N=55) and 0.42% (95% CI -5.45, 6.29, N=94) over 26 weeks (p=0.245 and 0.888) respectively.
Maltese: Fl-adoloxxenti (12-17-il sena) il-perċentaġġ relattiv tal-FEV1 previst meta mqabbel mal-kontroll tjieb b'3.31% (95% CI -2.29, 8.90, N=55) u b'0.42% (95% CI -5.
English: In DPM-CF-303 imputation of missing data was performed using a baseline observation carried forward (BOCF) approach whereas no imputation was performed in DPM-CF-301 or DPM-CF-302.
Maltese: F'DPM-CF-303 l-imputazzjoni ta' dejta nieqsa saret permezz ta' approċċ osservazzjoni tal-linja bażi mressqa 'l quddiem (BOCF) fejn ma saret l-ebda imputazzjoni f'DPM-CF-301 jew f'DPM-CF-302.
English: Oropharyngeal pain, Wheezing Uncommon Productive cough, Throat irritation, Asthma, Bronchospasm, Forced expiratory volume decreased, Rhinorrhoea, Dyspnoea Dysphonia, Hyperventilation, Obstructive airways disorder, Respiratory tract congestion, Sputum discoloured, Hypoxia
Maltese: Mhux komuni Sogħla produttiva, Irritazzjoni fil-griżmejn, Ażżma, Bronkospażmu, Tnaqqis fil-volum espiratorju furzat, Rinoreja, Dispneja, Disfonja, Iperventilazzjoni, Disturb ostruttiv fil-pajpijiet tan-nifs, Konġestjoni fl-apparat respiratorju, Sputum skulurit, Ipoxja
English: The estimated effect of treatment (mean change and 95% CI from baseline over 26 weeks, mITT population) on FVC was 108.78 ml (95% CI: 49.21, 168.35) in study 301 and 71.4 ml (95% CI: 10.57, 132.13) in study 302 and 40 ml (95% CI: -12, 92) in study 303.
Maltese: L-effett ta' kura stmat (tibdil medju u 95% CI mil-linja bażi fuq 26 ġimgħa, popolazzjoni mITT) fuq lFVC kien ta' 108.78 ml (95% CI: 49.21, 168.35) fl-istudju 301, 71.4 ml (95% CI: 10.
English: Table 3 - Change in FEV1 from baseline over 26 weeks in the mITT and adult populations
Maltese: Tabella 3 - Tibdil fl-FEV1 mil-linja bażi matul is-26 ġimgħa fil-popolazzjonijiet mITT u tal-adulti
English: Chiesi Pharma AB Tel: + 46 8 753 35 20
Maltese: Tel: + 46 8 753 35 20
English: The safety/efficacy of Bronchitol in patients with asthma has not been formally studied.
Maltese: Is-sigurtà/l-effikaċja ta' Bronchitol f'pazjenti bl-ażżma ma ġietx studjata formalment.
English: In study 301, overall the most frequently reported adverse reactions during the MTT were cough in 20 (5.3%) subjects, wheezing/bronchospasm in seven (1.9%) subjects and chest discomfort in six (1.6%) subjects.
Maltese: Fl-istudju 301, generalment ir-reazzjonijiet avversi l-aktar frekwenti matul lMTT kienu sogħla f'20 suġġett (5.3%), tħarħir/bronkospażmu f'seba' individwi (1.9%) u skumdità fis-sider f'sitt individwi (1.6%).
English: Bronchitol 40 mg inhalation powder, hard capsules contain a white or almost white powder filled into clear, colourless, hard, capsules with “PXS 40 mg” imprinted on them.
Maltese: Bronchitol 40 mg trab li jittieħed man-nifs, kapsuli iebsin fihom trab abjad jew kważi abjad mimli f'kapsuli ċari, bla kulur, iebsin b'“PXS 40 mg” stampata fuqhom.
English: IMED Poland Sp. z o. o. Tel: +48 22 663 43 10
Maltese: Tel: +48 22 663 43 10
English: In study DPM-CF-303 (N=423) the baseline FEV1 percent predicted was 63.17 (SD: 15.15) and 62.98 (SD: 13.65).In study DPM-CF-301 64.4 % of the patient population were adults while in study DPM-CF302 this figure was 49.5%.
Maltese: Fl-istudju DPM-CF-301 64.4 % tal-popolazzjoni tal-pazjenti kienu adulti filwaqt li fl-istudju DPM-CF-302 din il-figura kienet ta' 49.5%.
English: Uncommon Musculoskeletal chest pain
Maltese: Mhux komuni Uġigħ muskoloskeletali fis-sider
English: In female patients, the adjusted mean change in FEV1 was 27ml for Bronchitol and 44ml for the control arm, suggesting potentially inferior benefit on lung function with Bronchitol compared to the control, although the difference was not statistically significant (p=0.480).
Maltese: F'pazjenti nisa, il-bidla medja aġġustata fl-FEV1 kienet 27 ml għal Bronchitol u 44 ml għall-fergħa ta' kontroll, li tissuġġerixxi benefiċċju potenzjalment inferjuri fuq il-funzjoni talpulmun bi Bronchitol meta mqabbel mal-kontroll, għalkemm id-differenza ma kinitx statistikament sinifikanti (p=0.480).
English: What Bronchitol contains:
Maltese: X'fih Bronchitol:
English: Cough was commonly reported with use of Bronchitol in clinical studies (see section 4.8).
Maltese: Fi studji kliniċi s-sogħla kienet irrapportata b'mod komuni bl-użu ta' Bronchitol (ara sezzjoni 4.8).
English: The number of subjects with at least one protocol defined pulmonary exacerbation (PDPE, defined by the presence of at least 4 symptoms and signs plus the use of intravenous antibiotics) was 18.1% in the mannitol arm and 28% in the control arm in study 301 (ITT population).
Maltese: In-numru ta' individwi li kellhom mill-inqas aggravar pulmonari wieħed skont il-protokoll (PDPE, definit bil-preżenza ta' mill-inqas 4 sintomi u sinjali flimkien mal-użu ta' antibijotiċi ġol-vini) kien ta' 18.1% fil-fergħa ta' mannitol u ta' 28% fil-fergħa ta' kontroll fl-istudju 301 (popolazzjoni ITT).
English: Mean (SD) baseline FEV1 percent predicted in study DPM-CF-301 (safety population, N= 295) was 62.4 (SD:16.45) and 61.4 (SD:16.13) in the mannitol and control groups, respectively.
Maltese: Il-medja perċentwali (SD) tal-FEV1 fil-linja bażi prevista fl-istudju DPM-CF-301 (popolazzjoni ta' N= 295) kienet ta' 62.4 (SD:16.45) u ta' 61.4 (SD:16.
English: Bronchitol is for use in adults 18 years of age and over.
Maltese: Bronchitol għandu jintuża f'adulti minn 18-il sena 'l fuq.
English: What Bronchitol is Bronchitol contains a medicine called mannitol which is a mucolytic agent.
Maltese: X'inhu Bronchitol Bronchitol fih mediċina msejħa mannitol li hija sustanza mukolitika.
English: Table 1: Frequency of adverse reactions with Bronchitol in the phase 3 studies (initiation dose assessment and/or treatment phase)
Maltese: Tabella 1: Frekwenza ta' reazzjonijiet avversi bi Bronchitol fl-istudji ta' fażi 3 (valutazzjoni taddoża tal-bidu u/jew fażi tal-kura)
English: In the third study (DPM-CF-303) 423 adult patients were randomised in a 1:1 ratio to inhaled mannitol 400 mg twice daily or to control.
Maltese: Fit-tielet studju (DPM-CF-303) 423 pazjent adult ġew randomizzati fi proporzjon 1:1 sabiex jiġbdu man-nifs mannitol 400 mg darbtejn kuljum jew għal kontroll.
English: Uncommon Dizziness
Maltese: Mhux komuni Inkontinenza tal-awrina
English: No evidence of carcinogenicity was observed when dietary mannitol (≤5%) was administered to mice and rats for 2 years.
Maltese: Ma kienet osservata l-ebda evidenza ta' karċinoġeniċità meta mannitol ingħata mal-ikel (≤5%) lillġrieden u l-firien għal sentejn.
English: Uncommon Initial insomnia
Maltese: Mhux komuni Insomnja inizjali
English: The safety and efficacy of Bronchitol in children and adolescents aged 6 to 18 years has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Bronchitol fit-tfal u l-adoloxxenti minn 6 sa 18-il sena ma ġewx iddeterminati s'issa.
English: The recommended dose of Bronchitol is 400 mg twice a day.
Maltese: Id-doża rrakkomandata ta' Bronchitol hija ta' 400 mg darbtejn kuljum.
English: Bronchial hyperresponsiveness to inhaled mannitol (see section 4.4).
Maltese: Rispons eċċessiv tal-bronki għal mannitol li jittieħed man-nifs (ara sezzjoni 4.4).
English: • recurrent bleeding ≥100 ml/day over several days The reinstitution or withholding of Bronchitol following smaller episodes of haemoptysis should be based on clinical judgement.
Maltese: • tnixxija rikorrenti ta' demm ≥100 ml/kuljum għal bosta ġranet Il-bidu mill-ġdid jew iż-żamma ta' Bronchitol wara episodji iżgħar ta' emoptisi għandhom ikunu bbażati fuq ġudizzju kliniku.
English: Use Bronchitol as part of your normal daily treatment routine.
Maltese: Uża Bronchitol bħala parti mir-rutina tal-kura ta' kuljum normali tiegħek.
English: The treatment effect of Bronchitol on FEV1 was less evident in the subgroup of patients who were receiving concomitant rhDNase.In rhDNase users in study 301 the relative change in FEV1 % predicted from baseline across 26 weeks of treatment was 2.83 (95% CI -0.62, 6.27).
Maltese: Fl-utenti ta' rhDNase fl-istudju 301 it-tibdil relattiv fil-% flFEV1 previst mil-linja bażi fuq 26 ġimgħa ta' kura kien ta' 2.83 (95% CI -0.
English: o The need of pre-medication by a bronchodilator 5-15 minutes before the Bronchitol initiation dose assessment and before each therapeutic administration of Bronchitol.
Maltese: o Il-ħtieġa għal medikazzjoni minn qabel permezz ta' bronkodilatur 5-15 minuta qabel il-valutazzjoni tad-doża tal-bidu ta' Bronchitol u qabel kull għoti terapewtiku ta' Bronchitol.
English: • acute bleeding ≥240 ml in a 24-hour period
Maltese: • tnixxija akuta ta' demm ≥240 ml fuq perijodu ta' 24 siegħa
English: The risk of haemoptysis during treatment o That Bronchitol has not been studied in patients with a history of significant haemoptysis (>60 ml) in the previous three months.
Maltese: Ir-riskju ta' emoptisi matul il-kura o Li Bronchitol ma ġiex studjat f'pazjenti bi storja ta' emoptisi sinifikanti (>60 ml) fit-tliet xhur ta' qabel.
English: The primary pre-specified endpoint i.e. the change from baseline in FEV1 (ml) in the modified ITT (mITT) population (n=269, 297 and 423 in studies DPM-CF-301,DPM-CF-302 and DPM-CF-303, respectively) compared to control over the 26 weeks period is provided in Table 3 alongside FEV1 presented as absolute and relative change % predicted.
Maltese: Il-punt ta' tmiem primarju speċifikat minn qabel, jiġifieri l-bidla mil-linja bażi fl-FEV1 (ml) filpopolazzjoni tal-ITT modifikata (mITT) (n=269, 297 u 423 fl-istudji DPM-CF-301, DPM-CF-302 u
English: Bronchitol has not formally been studied in patients with impaired renal and hepatic function.
Maltese: Bronchitol ma ġiex formalment studjat f'pazjenti b'indeboliment tal-funzjoni tal-kliewi u tal-fwied.
English: Lung deposition studies have demonstrated a 24.7% deposition of inhaled mannitol confirming its distribution to the target organ.
Maltese: Studji dwar id-depożizzjoni fil-pulmun urew depożizzjoni ta' 24.7% ta' mannitol li jittieħed man-nifs li dan jikkonferma d-distribuzzjoni tiegħu fl-organu ippjanat.
English: Cough
Maltese: jew
English: The risk of bronchospasm during treatment o The need to perform the Bronchitol initiation dose assessment to identify patients who have bronchial hyperresponsiveness in response to inhaled mannitol by measuring the degree of bronchoconstriction that occurs following sequential administrations of mannitol.
Maltese: Ir-riskju ta' bronkospażmu waqt il-kura o Il-ħtieġa li ssir valutazzjoni tad-doża tal-bidu ta' Bronchitol biex jiġu identifikati pazjenti li għandhom rispons eċċessiv tal-bronki bħala reazzjoni għal mannitol li jittieħed man-nifs billi jitkejjel il-grad ta' bronkokostrizzjoni li jseħħ wara l-għoti sekwenzjali ta' mannitol.
English: Dornase alfa (Pulmozyme) if this is part of your treatment routine Inhaled antibiotics if this is part of your treatment routine
Maltese: Dornase alfa (jekk applikabbli) Antibijotiċi li jittieħdu min-nifs (jekk applikabbli)
English: In study 302 15.2% subjects in the mannitol arm and 19% in the control had a PDPE.
Maltese: 2% mis-suġġetti fil-fergħa ta' mannitol u 19% fil-kontroll kellhom PDPE.
English: What Bronchitol looks like and contents of the pack:
Maltese: Kif jidher Bronchitol u l-kontenut tal-pakkett:
English: Bronchospasm can occur with inhalation of medicinal product and has been reported with Bronchitol in clinical studies, even in patients who were not hyperresponsive to the initiation dose of inhaled mannitol (see section 4.8).
Maltese: Bronkospażmu jista' jseħħ permezz ta' inalazzjoni ta' prodott mediċinali u ġie rrapportat bi Bronchitol fi studji kliniċi, anki f'pazjenti li ma kinux ibatu minn rispons eċċessiv għad-doża tal-bidu ta' mannitol li ttieħed man-nifs (ara sezzjoni 4.8).
English: However, studies conducted with orally administered mannitol indicated no teratogenic effects in mice or rats, at doses of up to 1.6 g/kg, or in hamsters at 1.2 g/kg.
Maltese: Madankollu, studji li saru b'mannitol mogħti b'mod orali ma ndikaw l-ebda effett teratoġeniku fil-ġrieden jew fil-firien, f'dożi sa 1.6 g/kg, jew fil-ħamsters f'1.2 g/kg.
English: Infections and infestations Uncommon Bacterial disease carrier, Bronchitis, Bronchopneumonia, Lung infection, Oral candidiasis, Pharyngitis, Staphylococcal infection, Upper respiratory tract infection
Maltese: Infezzjonijiet u infestazzjonijiet Mhux komuni Trasportatur tal-mard batterjali, Bronkite, Bronkopnewmonja, Infezzjoni fil-pulmun,
English: No treatment-related adverse effect occurred greater than 13 fold the maximal therapeutic dose.
Maltese: Ma seħħew l-ebda avvenimenti avversi relatati mad-doża ogħla minn 13-il darba d-doża massima terapewtika.
English: Bronchitol is an inhaled hyperosmotic medicinal product.
Maltese: Bronchitol huwa prodott mediċinali iperosmotiku li jittieħed man-nifs.
English: Absolute mL
Maltese: mL Assolut
English: DPM-CF-301
Maltese: Stima tad-daqs tal-effett DPM-CF-301
English: All patients should be formally reviewed after approximately six weeks of Bronchitol treatment to assess for signs and symptoms suggestive of active substance induced bronchospasm.
Maltese: Il-pazjenti kollha għandhom jiġu formalment eżaminati wara madwar sitt ġimgħat ta' kura bi Bronchitol biex jiġu vvalutati għal sinjali u sintomi li jissuġġerixxu bronkospażmu indott minn sustanza attiva.