FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, an improvement of 6% in percent predicted FEV1 was obtained in about 30% versus 36% of the adult patients in the TOBI Podhaler and TOBI nebuliser solution group respectively.
Maltese: Barra minn hekk, inkiseb titjib ta' 6% fil-perċentwal imbassar għal FEV1 f'madwar 30% kontra 36% ta' pazjenti adulti f'TOBI Podhaler u l-grupp ta' soluzzjoni bin-nebulizzatur TOBI rispettivament.
English: TOBI Podhaler 28 mg inhalation powder, hard capsules tobramycin
Maltese: TOBI Podhaler 28 mg trab li jittieħed man-nifs, kapsuli ibsin tobramycin
English: After inhalation of a 112 mg single dose (4 x 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, the maximum serum concentration (Cmax) of tobramycin was 1.02 ± 0.53 μg/ml (mean ± SD) and the median time to reach the peak concentration (Tmax) was one hour.
Maltese: Wara li 112 mg ta' doża waħda (4 kapsuli ta' 28 mg) ta' TOBI Podhaler ittieħdu man-nifs minn pazjenti b'fibrożi ċistika, l-ogħla konċentrazzjoni ta' tobramycin fis-serum (Cmax) kienet ta' 1.02 ± 0.53 μg/ml (medja ± SD) u l-ħin medju biex tintlaħaq il-konċentrazzjoni massima (Tmax) kien ta' siegħa.
English: The recommended dose is 112 mg tobramycin (4 x 28 mg capsules), administered twice daily for 28 days.
Maltese: Id-doża rrakkomandata hi ta' 112 mg tobramycin (4 kapsuli tat-28 mg), mogħtija darbtejn kuljum għal 28 ġurnata.
English: This antibiotic belongs to a class called aminoglycosides.
Maltese: Dan l-antibijotiku jappartjeni lil klassi msejħa aminoglikosidi.
English: The apparent terminal half-life of tobramycin in serum after inhalation of a 112 mg single dose of TOBI Podhaler was approximately 3 hours in cystic fibrosis patients and consistent with the half-life of tobramycin after inhalation of tobramycin 300 mg/5 ml nebuliser solution (TOBI).
Maltese: Il-half-life terminali evidenti ta' tobramycin fis-serum wara li tittieħed man-nifs doża waħda ta' 112 mg TOBI Podhaler kienet ta' madwar 3 sigħat f'pazjenti b'fibrożi ċistika u konsistenti mal-half-life ta' tobramycin wara t-teħid man-nifs ta' soluzzjoni ta' tobramycin ta' 300mg/5 ml b'nebulizzatur (TOBI).
English: Serum concentrations
Maltese: Konċentrazzjonijiet fis-serum
English: Vascular disorders
Maltese: Disturbi vaskulari Emottiżi
English: Not known (frequency cannot be estimated from the available data)
Maltese: Mhux magħrufa (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli)
English: In clinical studies, patients receiving TOBI Podhaler continued to take dornase alfa, bronchodilators, inhaled corticosteroids and macrolides, no evidence of drug interactions with these medicines was identified.
Maltese: Fi studji kliniċi, pazjenti mogħtija TOBI Podhaler komplew jieħdu dornase alfa, dilitaturi tal-bronki, kortikosterojdi meħudin man-nifs u makrolidi, ma kienet identifikata l-ebda interazzjoni bejn ilmediċina u dawn il-mediċini.
English: The TOBI Podhaler Phase III clinical development programme consisted of two studies and 612 treated patients with a clinical diagnosis of CF, confirmed by quantitative pilocarpine iontophoresis sweat chloride test or well-characterised disease causing mutations in each cystic fibrosis transmembrane regulator (CFTR) gene, or abnormal nasal transepithelial potential difference characteristic of CF.
Maltese: Il-programm ta' żvilupp kliniku fil-Fażi III ta' TOBI Podhaler kien jikkonsisti f'żewġ studji u f'612il pazjent ikkurati minħabba dijanjosi klinika ta' fibrożi ċistika, ikkonfermat b'test kwantitattiv talkloru fl-għaraq ikkaġunat mill-pilokarpina jontoforeżi jew b'marda kkaratterizzata tajjeb li tikkawża mutazzjonijiet f'kull regulatur tal-ġene transmembranu tal-fibrożi ċistika (CFTR), jew b'differenza potenzjali tat-transepitilja nażali anormali karatteristika tal-fibrożi ċistika.
English: For safety results see section 4.8
Maltese: Għar-riżultati ta' sigurtà ara sezzjoni 4.8.
English: At the end of a 4-week dosing cycle of TOBI Podhaler (112 mg twice daily), maximum serum concentration of tobramycin 1 hour after dosing was 1.99 ± 0.59 µg/ml.
Maltese: Fi tmiem ċiklu ta' 4 ġimgħat ta' doża TOBI Podhaler (112 mg darbtejn kuljum), il-konċentrazzjoni massima ta' tobramycin fis-serum sa siegħa wara li ngħatat id-doża kienet ta' 1.99 ± 0.59 µg/ml.
English: Treatment with both TOBI Podhaler and tobramycin 300 mg/5 ml nebuliser solution (TOBI) resulted in relative increases from baseline to day 28 of the third treatment cycle in percent predicted FEV1 of 5.8% and 4.7%, respectively.
Maltese: Il-kura kemm b'TOBI Podhaler kif ukoll b'tobramycin 300 mg/5ml ta' soluzzjoni b'nebulizzatur (TOBI) wasslet għal żidiet relattivi mil-linja bażi sat-28 jum tat-tielet ċiklu ta' kura fil-perċentwali mbassra għal FEV1 ta' 5.8% u 4.7%, rispettivament.
English: ON TOBI Podhaler OFF TOBI Podhaler
Maltese: META MHUX TIEĦU TOBI Podhaler
English: In the patients aged <20 years the increase from baseline percent predicted FEV1 was larger: 11.3% for TOBI Podhaler and 6.9% for the nebuliser solution after 3 cycles.
Maltese: F'pazjenti ta' <20 sena ż-żieda mil-linja bażi talperċentwali mbassra għal FEV1 kienet akbar: 11.3% għal TOBI Podhaler u 6.9% għas-soluzzjoni binnebulizzatur wara 3 ċikli.
English: The most commonly reported adverse reactions in the main safety, active-controlled clinical study with TOBI Podhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.
Maltese: L-aktar effetti mhux mixtieqa rrappurtati waqt l-istudju kliniku ewlieni kkontrollat bl-attiv dwar issigurtà b'TOBI Podhaler kontra s-soluzzjoni fin-nebulizzatur tobramycin f'pazjenti b'fibrożi ċistika b'infezzjoni P. aeruginosa kienu sogħla, sogħla produttiva, deni, qtugħ ta' nifs, uġigħ orofarinġali, disfonja u emottiżi.
English: A numerically lower response in patients aged ≥20 years was observed: the change from baseline FEV1 observed in the patients aged ≥20 years was smaller (0.3% with TOBI Podhaler and 0.9% with TOBI nebuliser solution).
Maltese: Kien osservat rispons numerikament anqas f'pazjenti ta' ≥20 sena: il-bidla mil-linja bażi għal FEV1 li dehret fil-pazjenti ta' ≥20 sena kienet anqas (0.3% b'TOBI Podhaler u 0.9% bis-soluzzjoni bin-nebulizzatur TOBI).
English: In the active controlled studies, all patients were aged >6years old (range 6-66 years) with an FEV1 % predicted at screening of between 24% and 76%.
Maltese: Flistudji kkontrollati bl-attiv, il-pazjenti kollha kellhom >6 snin (bejn 6-66 sena) b'FEV1 % mbassar waqt l-iskrining ta' bejn 24% u 76%.
English: Sputum discoloured
Maltese: Indeboliment tal-fwied
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Maltese: Barra minn hekk, qed tingħata wkoll il-kategorija bil-frekwenza korrispondenti billi qed tintuża l-konvenzjoni li ġejja (CIOMS III) għal kull effett mhux mixtieq tal-mediċina: komuni ħafna (≥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); mhux magħruf: ma tistax tittieħed stima mid-data disponibbli).
English: Oropharnygeal pain
Maltese: Bidla fil-kulur tal-bżieq
English: In the absence of conventional susceptibility breakpoints for the inhaled route of administration, caution must be exercised in defining organisms as susceptible or insusceptible to inhaled tobramycin.
Maltese: Fin-nuqqas ta' breakpoints ta' suxxetibilità konvenzjonali għal amminitrazzjoni man-nifs, għandu jkun hemm kawtela meta jiġu ddefiniti organiżmi bħala suxxetibbli jew mhux suxxetibbli għal tobramycin meħud man-nifs.
English: In a randomised, double-blind, placebo-controlled, multicentre study, TOBI Podhaler 112 mg (4 x 28 mg capsules) was administered twice daily, for three cycles of 28 days on-treatment and 28 days off-treatment (a total treatment period of 24 weeks).
Maltese: Fi studju multiċentriku, randomizzat, double-blind, ikkontrollat bi plaċebo, 112 mg TOBI Podhlaer (4 kapsuli ta' 28 mg) ingħataw darbtejn kuljum, għal tliet ċikli ta' 28 jum ta' kura u 28 jum mhux ta' kura (perjodu sħiħ ta' kura ta' 24 ġimgħa).
English: In case of signs of acute toxicity, immediate withdrawal of TOBI Podhaler and testing of renal function are recommended.
Maltese: F'każ li jkun hemm sinjali ta' tossiċità gravi, huwa rrakkomandat li jitwaqqaf minnufih TOBI Podhaler u li jsir test tal-funzjoni tal-kliewi.
English: The extent of systemic exposure (AUC) was also similar for the 112 mg TOBI Podhaler dose and the 300 mg tobramycin nebuliser solution dose.
Maltese: Il-firxa tal-espożizzjoni sistemika (AUC) kienet ukoll simili kemm għad-doża ta' 112 mg TOBI Podhaler kif ukoll għad-doża ta' 300 mg soluzzjoni ta' tobramycin b'nebulizzatur.
English: In children under 13 years of age, discontinuations were more frequent in the TOBI nebuliser solution arm whereas in patients aged 13 to 19, discontinuation rates with both formulations were similar.
Maltese: Fittfal ta' taħt it-13 -il sena, in-nuqqas ta' tkomplija kienet iktar frekwenti bis-soluzzjoni fin-nebulizzatur TOBI waqt li f'pazjenti f'età ta' bejn it-13 u 19 -il sena, in-nuqqas ta' tkomplija biż-żewġ formulazzjonijiet kienet simili.
English: Each weekly carton contains 56 x 28 mg capsules (7 blisters with 8 capsules per blister), and a Podhaler device in its storage case.
Maltese: Kull kartuna għal ġimgħa fiha 56 kapsula ta' 28 mg (7 folji bi 8 kapsuli kull folja), u inhaler Podhaler fil-kontenitur tiegħu.
English: See also section 5.1 for the profile of response of TOBI Podhaler compared to tobramycin nebuliser solution.
Maltese: Ara wkoll sezzjoni 5.1 għall-profil ta' reazzjoni ta' TOBI Podhaler meta mqabbel massoluzzjoni tan-nebulizzatur tobramycin.
English: In a second open-label, multicentre study, patients received treatment with either TOBI Podhaler (112 mg) or tobramycin 300 mg/5 ml nebuliser solution (TOBI), administered twice daily for three cycles.
Maltese: Fit-tieni studju multiċentriku, open-label, il-pazjenti ngħataw kura jew b'TOBI Podhaler (112 mg) jew bi 300 mg/5 ml soluzzjoni ta' tobramycin b'nebulizzatur (TOBI), mogħtija darbtejn kuljum għal tliet ċikli.
English: Mylan Medical SAS
Maltese: IL-PRODOTT MEDIĊINALI
English: • Anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin.
Maltese: • Antikolinesterasi bħalma huma neostigmine u pyridostigmine (użati biex jikkuraw id-dgħufija fil-muskoli), jew tossina botulinika.
English: Haemoptysis
Maltese: Emoptażi (Haemoptysis)
English: • The other ingredients are DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), calcium chloride, sulfuric acid (for pH adjustment).
Maltese: • Is-sustanzi l-oħra huma DSPC 1,2-distearoyl-sn-glycero-3-phosphocholine, calcium chloride u sulphuric acid (għall-aġġustament tal-pH).
English: TOBI Podhaler is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment.
Maltese: TOBI Podhaler jittieħed f'ċikli alternati jiġifieri 28 jum ta' kura segwiti bi 28 jum bla kura.
English: Hypersensitivity to the active substance and any aminoglycoside, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva u għal kull aminoglikoside, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Inhalation powder, hard capsules 56 capsules + 1 inhaler
Maltese: U KONTENUT Trab li jittieħed man-nifs, kapsuli ibsin 56 kapsula + inhaler wieħed
English: • Replace the mouthpiece and repeat steps 8,9 and 10.
Maltese: • Erġa' poġġi l-bokkin u rrepeti Stadji 8, 9 u 10.
English: In the active-controlled study, administration of a TOBI Podhaler dose was faster with a mean difference of approximately 14 minutes (6 minutes vs. 20 minutes with the nebuliser solution).
Maltese: Fl- istudju kkontrollat bl-attiv, l-għoti tad-doża ta' TOBI Podhaler saret f'anqas ħin b'differenza medja ta' madwar 14-il minuta (6 minuti vs. 20 minuta bis-soluzzjoni b'nebulizzatur).
English: Monitoring of serum tobramycin concentrations
Maltese: Monitoraġġ tal-konċentrazzjonijiet ta' tobramycin fis-serum
English: Capsule card
Maltese: Folja bil-kapsuli
English: Nephrotoxicity has been reported with the use of parenteral aminoglycosides.
Maltese: Kienet irrappurtata nefrotossiċità bl-użu ta' aminoglikosidi parenterali.
English: Immediately insert the capsule into the inhaler chamber.
Maltese: Daħħal minnufih il-kapsula fit-toqba tal-kapsula fl-inhaler.
English: The main resistance mechanisms are drug efflux and drug inactivation by modifying enzymes.
Maltese: Il-mekkaniżmi ta' reżistenza ewlenin huma effluss u inattivazzjoni tal-mediċina minn enżimi modifikaturi.
English: Date of first authorisation: 20 July 2011 Date of latest renewal: 18 February 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Lulju 2011
English: • Replace the mouthpiece and repeat Steps 7, 8 and 9.
Maltese: • Erġa' poġġi l-bokkin u rrepeti Stadji 7, 8 u 9.
English: Animal studies with tobramycin do not indicate a teratogenic effect (see section 5.3).
Maltese: Studji f'annimali b'tobramycin ma jurux effett teratoġeniku (ara sezzjoni 5.3).
English: Patients with serum creatinine 2 mg/dl or more and blood urea nitrogen (BUN) 40 mg/dl or more have not been included in clinical studies and there are no data in this population to support a recommendation for or against dose adjustment with TOBI Podhaler.
Maltese: Pazjenti b'2 mg/dl kreatinina fis-serum jew aktar u b'40 mg/dl nitroġenu urea fid-demm (BUB) jew aktar ma kenux inklużi fl-istudji kliniċi u m'hemmx informazzjoni minn din il-popolazzjoni li tgħinna rressqu rakkomandazzjoni favur l-aġġustament taddoża b'TOBI Podhaler jew kontrih.
English: Remove inhaler from mouth, and hold breath for approximately 5 seconds, then exhale normally away from the inhaler.
Maltese: Neħħi l-inhaler minn ħalqek, u żomm in-nifs għal madwar 5 sekondi, umbagħad onfoħ 'il barra normali imma mhux fl-inhaler.
English: In comparison, after inhalation of a single dose of tobramycin 300 mg/5 ml nebuliser solution (TOBI), Cmax was 1.04 ± 0.58 µg/ml and median Tmax was one hour.
Maltese: Għall-kuntrarju, wara li ttieħdet man-nifs doża waħda ta' 300 mg/5 ml soluzzjoni ta' tobramycin b'nebulizzatur (TOBI), is-Cmax kien ta' 1.04 ± 0.58 µg/ml u l-medja tat-Tmax kienet ta' siegħa.
English: Reinspect capsule.
Maltese: Tiblax il-kapsuli.
English: Monthly pack.
Maltese: 6 sigħat.
English: 56 inhalation powder, hard capsules and 1 inhaler (weekly pack) 224 (4 x 56) inhalation powder, hard capsules and 5 inhalers (monthly multipack) 448 (8 x 56) inhalation powder, hard capsules and 10 inhalers (2 x monthly multipack wrapped in foil)
Maltese: 224 (4 x 56) kapsula iebsa bi trab li jittieħed man-nifs u 5 inhalers (pakkett b'ħafna għal xahar) 448 (8 x 56) kapsula iebsa bi trab li jittieħed man-nifs b'10 inhalers (pakketti b'ħafna għal xahrejn imgeżwrin fil-fojl)
English: Such coumpounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
Maltese: Dawn il-komponenti jistgħu jżidu t-tossiċità minn aminoglikosidi billi jalteraw il-konċentrazzjonijiet antibijotiċi fis-serum u ttessut.
English: Nephrotoxicity
Maltese: Kategorija talfrekwenza
English: Inhalation powder, hard capsule
Maltese: Jekk tbattlet, armi l-kapsula.
English: TOBI Podhaler 28 mg inhalation powder, hard capsules
Maltese: TOBI Podhaler 28 mg trab li jittieħed man-nifs, kapsuli ibsin
English: TOBI Podhaler is administered by inhalation using the Podhaler device (see section 6.6 for detailed instructions for use).
Maltese: TOBI Podhaler jingħata b'inalazzjoni billi jintuża l-inhaler Podhaler (ara sezzjoni 6.6 għal tagħrif iddetaljat dwar kif jintuża).
English: • Vomiting, nausea
Maltese: • Rimettar, nawsja
English: The European Medicines Agency has waived the obligation to submit the results of studies with TOBI Podhaler in one or more subsets of the paediatric population in treatment of pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'TOBI Podhaler f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-kura talinfezzjoni/kolonizzazzjoni pulmonari pseudomonas aeruginosa b'fibrożi ċistika (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: • hearing problems (including noises in the ears and dizziness)
Maltese: • problemi fis-smigħ (inkluż ħsejjes fil-widnejn u sturdamenti)
English: After inhalation of a 112 mg single dose (4 x 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, sputum Cmax of tobramycin was 1047 ± 1080 µg/g (mean ± SD).
Maltese: Wara li 112 mg ta' doża waħda (4 kapsuli ta' 28 mg) ta' TOBI Podhaler ttieħdu man-nifs minn pazjenti b'fibrożi ċistika, is-Cmax ta' tobramycin fl-isputum kienet ta' 1047 ±1080 μg/g (medja ± SD). Għall-kuntrarju, wara li ttieħdet man-nifs doża waħda ta' 300 mg soluzzjoni ta' tobramycin b'nebulizzatur (TOBI), is-Cmax fl-isputum kienet ta' 737.3 ± 1028.4 µg/g.
English: Do not overtighten.
Maltese: Irrepeti ċ-ċiklu
English: • Cough, productive cough, voice alteration (hoarseness)
Maltese: • Sogħla, sogħla produttiva, tibdil fil-vuċi (ħanqa)
English: Do not push capsule through foil.
Maltese: Timbuttax il-kapsula minn ġol-fojl.
English: • Store in the original packaging in order to protect from moisture.
Maltese: • Żomm fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: • Nosebleed
Maltese: • Tinfaġar
English: Wheezing
Maltese: Dijarea
English: Urea and creatinine levels should be reassessed after every 6 complete cycles of TOBI Podhaler therapy.
Maltese: Il-livelli tal-urea u tal-kreatinina għandhom ikunu evalwati mill-ġdid wara kull 6 ċikli kompluti ta' terapija b'TOBI Podhaler.
English: Mylan EPD Kft. Tel: +36 1 465 2100
Maltese: Tel: +36 1 465 2100
English: TOBI Podhaler significantly improved lung function compared with placebo, as shown by the relative increase in percent predicted FEV1 of about 13% after 28 days of treatment.
Maltese: TOBI Podhaler tejjeb b'mod qawwi l-funzjoni tal-pulmun meta mqabbel mal-plaċebo, kif jidher fiżżieda relattiva fil-perċentwali mbassra għal FEV1 b'madwar 13% wara 28 jum ta' kura.
English: • The chances of the capsule breaking into pieces will be increased if the capsule is accidentally pierced more than once or if the device is not held with the mouthpiece pointing down during step 7.
Maltese: • Il-probabbiltajiet li l-kapsula titkisser f'biċċiet jiżdiedu jekk il-kapsula tittaqqab bi żball għal aktar minn darba jew jekk l-inhaler mhux qed jinżamm bil-bokkin iħares 'l isfel waqt Stadju 7.
English: Hearing loss
Maltese: Imnieħer misdud
English: In the active-controlled open-label study, patients aged 20 years and older tended to discontinue more frequently with TOBI Podhaler than with the nebuliser solution; discontinuations due to adverse events accounted for about half of the discontinuations with each formulation.
Maltese: Fl-istudju open label ikkontrollat bl-attiv, dawk il-pazjenti li kellhom minn 20 sena ‘l fuq kellhom iktar it-tendenza li ma jkomplux b'TOBI Podhaler milli bis-soluzzjoni fin-nebulizzatur; in-nuqqas ta' tkomplija dovuti għal każijiet avversi kienu jkopru madwar nofs il-każijiet ma' kull formulazzjoni.
English: TOBI Podhaler inhalation powder, hard capsules consist of a white to almost white powder for inhalation filled into clear colourless hard capsules with “NVR AVCI” imprinted in blue ink on one part of the capsule and the Novartis logo imprinted in blue on the other part of the capsule.
Maltese: Kapsuli ċari bla kulur li fihom trab jagħti fl-abjad jew kważi fl-abjad, b'“NVR AVCI” stampata bil-blu fuq naħa waħda tal-kapsula u bil-lowgo ta' Novartis stampat bil-blu fuq in-naħa l-oħra tal-kapsula.
English: Nephrotoxicity was not observed during TOBI Podhaler clinical studies.
Maltese: Ma kienx hemm nefrotossiċità waqt l-istudji kliniċi b'TOBI Podhaler.
English: Inhale the content of 4 capsules twice a day (4 capsules in the morning and 4 capsules in the evening), using the Podhaler device.
Maltese: Iġbed man-nifs il-kontenut ta' 4 kapsuli darbtejn kuljum (4 kapsuli filgħodu u 4 kapsuli filgħaxija), billi tuża l-inhaler Podhaler.
English: How to take TOBI Podhaler
Maltese: Tiħux TOBI Podhaler
English: Haemoptysis is a complication in cystic fibrosis and is more frequent in adults.
Maltese: L-emoptażi hija kumplikazzjoni tal-fibrożi ċistika u hija aktar frekwenti fl-adulti.
English: • 1 inhaler (the Podhaler device) and its storage case.
Maltese: • inhaler wieħed (l-inhaler Podhaler) u l-kontenitur fejn jintrefa'.
English: Mylan Healthcare B.V. Tel: +31 20 426 3300
Maltese: Mylan Healthcare d.o.o. Tel: +386 1 23 63 180
English: Sputum from cystic fibrosis exhibits an inhibitory action on the local biological activity of inhaled aminoglycosides.
Maltese: Sputum mill-fibrożi ċistika juri azzjoni inibitorja fl-attività bijoloġika lokali ta' aminogliċidi mdaħħla man-nifs.
English: Based on clinical trial data the inhalation powder TOBI Podhaler was associated with a higher reported rate of cough compared with tobramycin nebuliser solution (TOBI).
Maltese: Skont data minn provi kliniċi, it-trab ta' inalazzjoni TOBI Podhaler ġie assoċjat ma' rata ogħla rrapurtata ta'sogħla meta mqabbla mas-soluzzjoni bin-nebulizzatur tobramycin (TOBI).
English: Step 8, using the same capsule.
Maltese: Ħu t-3 kapsuli l-oħra bl-istess mod.
English: Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.
Maltese: It-tossiċità vestibulari tista' tidher permezz ta' vertigo, atassja jew sturdament.
English: • Decreasing hearing (ringing in the ears is a potential warning sign of hearing loss), noises (such as hissing) in the ears (common).
Maltese: • Tnaqqis fis-smigħ (iż-żarżir fil-widnejn huwa sinjal potenzjali ta' twissija li jindika nuqqas ta'
English: After you have taken TOBI Podhaler for 28 days, you then have a 28-day break, during which you do not inhale any TOBI Podhaler.
Maltese: Wara li tkun ħadt TOBI Podhaler għal 28 jum, umbagħad għandek waqfa ta' 28 jum, li matulhom m'inti se tieħu l-ebda TOBI Podhaler man-nifs.
English: TOBI Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.
Maltese: TOBI Podhaler huwa indikat biex jintuża mill-adulti u t-tfal minn 6 snin jew akbar b'fibrożi ċistika bħala terapija suppressiva f'każ ta' infezzjoni pulmonari kronika bi Pseudomonas aeruginosa.
English: Chest discomfort
Maltese: Komuni ħafna
English: • 4 capsules in the evening to be inhaled using the Podhaler device.
Maltese: • 4 kapsuli filgħodu li jridu jittieħdu man-nifs permezz tal-inhaler Podhaler.
English: In the event of accidental oral ingestion of TOBI Podhaler capsules, toxicity is unlikely as tobramycin is poorly absorbed from an intact gastrointestinal tract.
Maltese: F'każ li l-kapsuli TOBI Podhaler jinbelgħu bi żball, mhuwiex probabbli li jkun hemm tossiċità minħabba li t-tobramycin ma tantx tiġi assorbita tajjeb minn passaġġ gastrointestinali intatt.
English: What is Pseudomonas aeruginosa
Maltese: Pseudomonas aeruginosa Haemophilus influenzae Staphylococcus aureus
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-MP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Resistance to tobramycin involves different mechanisms.
Maltese: Ir-reżistenza għal tobramycin tinvolvi mekkaniżmi differenti.
English: • Platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer).
Maltese: • Komposti ta' platinu bħalma huma l-carboplatin u ċ-cisplatin (użati biex jikkuraw xi forom ta' kanċer).
English: Unscrew mouthpiece (1) and remove the capsule from the chamber (2).
Maltese: Ħoll il-bokkin (1) u neħħi l-kapsula mit-toqba tal-kapsula fl-inhaler (2).