FrancophonIA/ELRC3.0 huggingface dataset:
English: Izba is expected to be effective and safe in children from 3 years of age, based on adult studies and a study of 40 microgram/ml travoprost solution in children.
Maltese: Izda huwa mistenni li jkun effettiv u sigur fit-tfal minn 3 snin ‘fuq, skont studji fl-adulti u studju ta' 40 mikrogramma/ml ta' soluzzjoni ta' travoprost fit-tfal.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Izba on 20 February 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Izba fl-20 ta' Frar 2014.
English: The safety profile of Izba seemed more favourable than that of the higher-strength solution, as side effects were less frequent with Izba.
Maltese: Ilprofil ta' sigurtà ta' Izba deher aktar favorevoli minn dak tas-soluzzjoni ta' doża ogħla, peress li l-effetti sekondarji kienu inqas frekwenti b'Izba.
English: In the study of children with glaucoma or ocular hypertension given Travatan, the average eye pressure was reduced by around 27% after 12 weeks.
Maltese: FL-istudju fit-tfal bil-glawkoma jew l-ipertensjoni okulari li ngħataw Travatan, il-pressjoni medja fl-għajn tnaqqset b'madwar 27% wara 12-il ġimgħa.
English: An eye-drop solution containing travoprost at a concentration of 40 microgram/ml has been already authorised in the EU as Travatan since 2001.
Maltese: Soluzzjoni għall-qtar fl-għajnejn li fiha travoprost b'konċentrazzjoni ta' 40 mikrogramma/ml diġà ġiet awtorizzata fl-UE bħal Travatan mill-2001.
English: Izba is available as an eye-drop solution (30 microgram/ml) and can only be obtained with a prescription.
Maltese: Izba jiġi bħala soluzzjoni għall-qtar fl-għajnejn (30 mikrogramma/ml) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Evidence from studies with Izba in adults and with Travatan in children has also been used to work out the effectiveness of Izba in children.
Maltese: Intużat ukoll evidenza mill-istudji b'Izba fl-adulti u bi Travatan fit-tfal biex tinħadem l-effikaċja ta' Izba fit-tfal.
English: For the full list of all side effects and restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha, ara l-fuljett ta' tagħrif.
English: In the eye, prostaglandins increase the drainage of the watery fluid (aqueous humour) out of the eyeball.
Maltese: Fl-għajn, il-prostaglandini jżidu s-sistema li minnha l-fluwidu likwidu fl-għajn (aqueous humour) joħroġ 'il barra mill-boċċa tal-għajn.
English: It is not intended to provide practical advice on how to use Izba.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Izba.
English: How does Izba work?
Maltese: Kif jaħdem Izba?
English: Izba acts in the same way and increases the flow of fluid out of the eye.
Maltese: Izba jaġixxi bl-istess mod u jżid il-fluss tal-fluwidu 'l barra mill-għajn.
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 Seebri 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 Seebri Breezhaler u plaċebo rispettivament.
English: Seebri 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 Seebri 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: In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Seebri Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Seebri Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
Maltese: Fl-istudju ta' 6 xhur, il-persentaġġ ta' pazjenti li kellhom taħrix moderat jew sever kien ta' 17.5% għal Seebri 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 Seebri Breezhaler u ta' 40.2% għallplaċebo (Proporzjon ta' periklu: 0.66, p=0.001).
English: Seebri Breezhaler 44 mcg inhalation powder glycopyrronium
Maltese: Seebri Breezhaler 44 μg trab li jittieħed man-nifs glycopyrronium
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 Seebri 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' Seebri Breezhaler u kienu ttollerati sew.
English: PA/Alu/PVC - Alu perforated unit-dose blister Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.
Maltese: Folja pperforata b'dożi waħdiena PA/Alu/PVC - Alu Pakketti li fihom 6x1, 10x1, 12x1 jew 30x1 kapsula iebsa, flimkien ma' inhaler wieħed.
English: Seebri Breezhaler administered at 44 micrograms once daily statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI).
Maltese: Seebri 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: Seebri Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Seebri Breezhaler hu indikat bħala trattament bronkodilatatur ta' manutenzjoni biex iserraħ lil pazjenti adulti minn sintomi ta' mard pulmonari ostruttiv kroniku (COPD).
English: Date of first authorisation: 28 September 2012 Date of latest renewal: 19 July 2017
Maltese: Data tal-aħħar tiġdid: 19 Lulju 2017
English: In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) Seebri 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) Seebri Breezhaler jista' jintuża skont id-doża rrakkomandata.
English: No specific side effects have been reported when Seebri 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 Seebri 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: Seebri Breezhaler 44 micrograms inhalation powder, hard capsules glycopyrronium (as glycopyrronium bromide)
Maltese: Seebri Breezhaler 44 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa glycopyrronium (bħala glycopyrronium bromide)
English: Seebri 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: Seebri 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: Seebri Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8).
Maltese: Seebri Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti anzjani (minn 75 sena 'l fuq) (ara sezzjoni 4.8).
English: In the 12-month study, the improvements were 87 ml at 5 minutes and 143 ml at 15 minutes (both p<0.001).
Maltese: Flistudju li dam 12-il xahar, it-titjib kien ta' 87 ml fi żmien 5 minuti u ta' 143 ml fi żmien 15-il minuta (it-tnejn p<0.001).
English: This includes medicines similar to Seebri Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).
Maltese: Dan jinkludi mediċini simili għal Seebri Breezhaler użati għall-mard li għandek tal-pulmun, bħal ipratropium, oxitropium jew tiotropium (imsejħa wkoll antikolinerġiċi).
English: What Seebri Breezhaler contains - The active substance is glycopyrronium bromide.
Maltese: X'fih Seebri Breezhaler - Is-sustanza attiva hi glycopyrronium bromide.
English: In clinical studies with Seebri Breezhaler, paradoxical bronchospasm was not observed.
Maltese: Fi studji kliniċi b'Seebri Breezhaler, ma kienx hemm spażmi paradossali tal-bronki.
English: 1) More frequent for glycopyrronium than placebo in the 12 months database only.
Maltese: 1) Iżjed frekwenti bi glycopyrronium milli bil-plaċebo fid-database ta' 12-il xahar biss.
English: 6 or 10 Seebri Breezhaler capsules to be used in the inhaler
Maltese: 10 kapsuli Seebri Breezhaler biex jintużaw mal inhaler
English: • One Seebri Breezhaler inhaler
Maltese: • Inhaler wieħed Seebri Breezhaler
English: The magnitude of the effect was dependent on the degree of reversibility of airflow limitation at baseline (tested by administration of a short-acting muscarinic antagonist bronchodilator): Patients with the lowest degree of reversibility at baseline (<5%) generally exhibited a lower bronchodilator response than patients with a higher degree of reversibility at baseline (≥5%).
Maltese: Il-qawwa tal-effett kienet tiddependi mill-grad ta' riversibbiltà tal-limitazzjoni tal-mogħdija tal-arja fil-linja bażi (ippruvat bl-għoti ta' bronkodilatatur tal-antagonist muskariniku li jaħdem għal ftit żmien): Pazjenti bl-anqas grad ta' riversibbiltà fil-linja bażi (<5%) ġeneralment urew rispons aktar baxx tal-bronkodilatatur minn pazjenti bi grad ogħla ta' riversibbiltà fil-linja bażi (≥5%).
English: Seebri Breezhaler 44 micrograms inhalation powder, hard capsules
Maltese: Seebri Breezhaler 44 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa
English: No change in mean heart rate or QTc interval was observed with Seebri 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'Seebri Breezhaler b'dożi sa 176 mikrogramma f'pazjenti b'COPD.
English: In the 6-month study, Seebri 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, Seebri 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: In a pooled analysis of the 6and 12-month pivotal studies a statistically significantly higher percentage of patients receiving Seebri 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 Seebri 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: At 12 weeks (primary endpoint), Seebri 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), Seebri Breezhaler żied il-FEV1 minimu bi 72 ml fil-pazjenti blinqas 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: Show the pack of Seebri Breezhaler.
Maltese: Uri l-pakkett ta' Seebri Breezhaler.
English: The capsules must be administered only using the Seebri Breezhaler inhaler (see section 6.6).
Maltese: Il-kapsuli għandhom jittieħdu biss billi jintuża l-inhaler Seebri Breezhaler (ara sezzjoni 6.6).
English: • Do not use the Seebri Breezhaler capsules with any other inhaler.
Maltese: • Tużax il-kapsuli Seebri Breezhaler ma' xi inhaler ieħor.
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 Seebri 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 Seebri Breezhaler għallkuntrarju tal-half-life wara l-għoti mill-vina (ara sezzjoni 5.2).
English: Although no formal drug interaction studies have been performed, Seebri 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, Seebri Breezhaler intuża flimkien ma' prodotti mediċinali oħrajn użati normalment waqt it-trattament ta' COPD mingħajr evidenza klinika ta' interazzjonijiet bejn il-mediċini.
English: Acute intoxication by inadvertent oral ingestion of Seebri Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%).
Maltese: Mhux mistenni li jkun hemm effett tossiku gravi meta l-kapsuli Seebri Breezhaler jinbelgħu bi żball mill-ħalq minħabba l-bijodisponibbiltà orali baxxa (madwar 5%).
English: What Seebri Breezhaler looks like and contents of the pack Seebri Breezhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder.
Maltese: Kif jidher Seebri Breezhaler u l-kontenut tal-pakkett Il-kapsuli iebsin ta' Seebri Breezhaler 44 mikrogramma trab li jittieħed man-nifs, huma trasparenti u oranġjo u fihom trab abjad.
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, Seebri 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, Seebri Breezhaler għandu jintuża biss jekk il-benefiċċji mistennija jegħlbu r-riskju li jista' jkun hemm (ara sezzjoni 5.2).
English: In the 12-month study, Seebri 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, Seebri 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: Your Seebri Breezhaler Inhaler pack contains:
Maltese: Dawn huma l-qisien tal-pakketti disponibbli:
English: The following pack sizes are available: Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.
Maltese: Pakketti li fihom 6 x 1, 10 x 1, 12 x 1 jew 30 x 1 kapsula iebsa, flimkien ma' inhaler wieħed.
English: In a pooled analysis of the first 6 months of treatment in the 6- and 12-month studies, compared to placebo Seebri 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 Seebri 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: Seebri Breezhaler also reduced dyspnoea at rest measured using the Transitional Dyspnoea Index.
Maltese: Seebri Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti b'indeboliment tal-kliewi bejn ħafif u moderat.
English: 2) Reports have been received from post-approval marketing experience in association with the use of Seebri Breezhaler.
Maltese: 2) Wara li l-prodott tqiegħed fis-suq, waslulna rapporti b'rabta mal-użu ta' Seebri Breezhaler.
English: Seebri Breezhaler contains lactose
Maltese: Seebri Breezhaler fih il-lactose
English: Seebri 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: Seebri 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: At 12 weeks (primary endpoint), Seebri 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), Seebri 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: Other medicines and Seebri Breezhaler
Maltese: Kif taħżen Seebri Breezhaler
English: A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Seebri 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 Seebri 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, Seebri 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, Seebri Breezhaler għandu jintuża biss jekk il-benefiċċji mistennija jegħlbu r-riskju li jista' jkun hemm (ara sezzjoni 4.4).
English: Seebri Breezhaler is used as a maintenance treatment for your COPD.
Maltese: Seebri Breezhaler jintuża bħala trattament ta' manutenzjoni għas-COPD.
English: The pooled analysis also showed fewer patients treated with Seebri 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'Seebri Breezhaler milli dawk bi plaċebo li kellhom taħrix u li kienu jeħtieġu kura l-isptar (1.7% kontra 4.2%, p=0.003).
English: After three weeks of treatment the improvement in inspiratory capacity with Seebri 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'Seebri 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: The absolute bioavailability of glycopyrromium inhaled via Seebri Breezhaler was estimated to be about 45% of the delivered dose.
Maltese: Il-bijodisponibbiltà assoluta ta' glycopyrronmium meħud man-nifs permezz ta' Seebri Breezhaler kienet stmata li hi ta' madwar 45% tad-doża meħuda.
English: Seebri Breezhaler 44 micrograms once daily can be safely used in all age and body weight groups.
Maltese: 44 mikrogramma Seebri Breezhaler darba kuljum jistgħu jintużaw bla periklu minn nies ta' kull età u piż.
English: Side buttons
Maltese: Vojta it-trab
English: • High level of blood sugar (hyperglycaemia: typical symptoms include excessive thirst or hunger and frequent urination)
Maltese: • Uġigħ inti u tgħaddi l-awrina u awrina frekwenti
English: Pruritus
Maltese: Fadal
English: The European Medicines Agency has waived the obligation to submit the results of studies with Seebri 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'Seebri Breezhaler f'kull sett tal-popolazzjoni pedjatrika fil-COPD (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: • Nose bleeds
Maltese: • Taħsir tas-snien
English: EMA/51634/2016 EMEA/H/C/002155
Maltese: EMA/51634/2016 EMA/H/C/002155
English: This summary was last updated in 02-2016.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi 02-2016.
English: Tobi Podhaler tobramycin
Maltese: Tobi Podhaler tobramiċina
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Tobi Podhaler can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Tobi Podhaler jinstab fis-sit web tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR for Tobi Podhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Tobi Podhaler, tobramycin, is an antibiotic that belongs to the group ‘aminoglycosides'.
Maltese: Is-sustanza attiva f'Tobi Podhaler, it-tobramiċina, hija antibijotiku li tagħmel parti mill-grupp ta' "aminoglikosidi".
English: They also presented data from the published literature.
Maltese: Ippreżenta wkoll data mid-dokumentazzjoni ppubblikata.
English: This is a summary of the European public assessment report (EPAR) for Tobi Podhaler.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Tobi Podhaler.
English: The first trial, which involved 102 patients aged 6 to 21 years, compared Tobi Podhaler with placebo (a dummy treatment), while the second, involving 553 mostly adult patients, compared it with Tobi.
Maltese: L-ewwel prova, li fiha ħadu sehem 102 pazjenti ta' bejn is-6 u l-21 sena, qabblet Tobi Podhaler ma' plaċebo (kura finta), filwaqt li t-tieni, li fiha ħadu sehem 553 pazjent li lmaġġoranza tagħhom kienu adulti, qabblitu ma' Tobi.