FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Maltese: Pazjenti li kienu qed jirċievu pioglitazone kellhom tnaqqis medju f'HbA1c ta' 0.45 % meta mqabbel ma dawk li komplew b'insulina waħedha, u tnaqqis fid-doża ta' l-insulina fil-grupp ikkurat b'pioglitazone.
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Maltese: Huwa meqjus li l farmakokinetika tal-assorbiment ta' metformin mhix linejari.
English: Competact should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Maltese: Indeboliment epatiku Competact m'għandux jintuża f'pazjenti b'indeboliment epatiku (ara sezzjonijiet 4.3 u 4.4).
English: Mon. 2
Maltese: E 2
English: Lactic acidosis
Maltese: Tfal u adolexxenti
English: Therapy with Competact should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.
Maltese: Terapija b'Competact m'għandiex tinbeda f'pazjenti b'livelli ta' l-enżimi tal-fwied fil-linja bażika miżjuda (ALT > 2.5 x l-għola limitu tan-normal) jew b'xi evidenza oħra ta' mard tal-fwied.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq il-folja wara ‘EXP'.
English: Sun. 1
Maltese: S 1
English: Very common (may affect more than 1 in 10 people) - stomach ache - feeling sick (nausea) - vomiting - diarrhoea - loss of appetite
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - nefħa lokalizzata (edema) - żieda fil-piż - uġigħ ta' ras
English: Uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - gas - difficulty sleeping (insomnia)
Maltese: - infjammazzjoni tas-sinus (sinusite) - gass - diffikultà fl-irqad (insonnja)
English: Clinical trials have been conducted with Competact tablets and co-administered pioglitazone and metformin (see section 5.1).
Maltese: Twettqu provi kliniċi kemm b'pilloli Competact kif ukoll bi pioglitazone u metformin mogħtija fl-istess waqt (ara Sezzjoni 5.1).
English: Thu.
Maltese: T
English: Infections and infestations upper respiratory tract infection common common sinusitis uncommon uncommon
Maltese: - infezzjoni respiratorja - vista mhux normali
English: If no adequate strength of Competact is available, individual monocomponents should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Competact, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.
Maltese: Il-fertilità fil-ferien maskili jew femminili ma kienitx effettwata bil-metformin meta ingħatat f'dożi għolja sa 600 mg/kg/jum, li hi bejn wieħed u ieħor tliet darbiet tad-doża massima ta' kuljum fl-umani rrakkomandata bbażata fuq tqabbil tal-erja superfiċje tal-ġisem.
English: Blood and lymphatic system disorders anaemia common
Maltese: Disturbi tad-demm u tas-sistema limfatika anemija komuni
English: Sun. 2
Maltese: S 2
English: 2 Long term treatment of metformin has been associated with a decrease of vitamin B12 absorption with decrease of serum levels.
Maltese: B12 bi tnaqqis tal-livelli fis-serum.
English: Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Maltese: Pioglitazone jidher li jaħdem permezz ta' attivazzjoni ta' riċetturi nuklejari speċifiċi (proliferatur ta' peroxisome ta' riċettur gamma attivat) li jwassal għal żieda fis-sensittività għall-insulina tal-fwied, xaħam u ċelloli tal-muskoli skeletrali fl-annimali.
English: Skin and subcutaneous tissue disorders erythema very rare very rare pruritis very rare very rare urticaria very rare very rare
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda eritima rari ħafna rari ħafna prurite rari ħafna rari ħafna urtikarja rari ħafna rari ħafna
English: These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Maltese: Dawn is-sejbiet kienu osservati fi speċi differenti b'konċentrazzjonijiet fil-plażma ≤ 4 darbiet l-espożizzjoni klinika.
English: It is an anti-diabetic medicine used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone is not sufficient.
Maltese: Huwa mediċina anti-dijabetika wżata fl'adulti biex tikkura dijabete mellitus tat-tip 2 (mhux dipendenti mill-insulina) meta kura bil-metformin biss mhux suffiċjenti.
English: Package leaflet: Information for the patient Competact 15 mg/850 mg film-coated tablets pioglitazone/metformin hydrochloride
Maltese: Pilloli Competact 15 mg/850 mg pioglitazone/metformin idrokloridu
English: Pregnancy
Maltese: Ipromellosi
English: Patients with hepatic impairment
Maltese: - Indeboliment epatiku
English: Competact should be discontinued if any deterioration in cardiac status occurs.
Maltese: insulina jew f'pazjenti b'passat ta' insuffiċjenza kardijaka.
English: Food had no effect on the AUC and Cmax of pioglitazone when Competact was administered to healthy volunteers.
Maltese: L-ikel ma kellu l-ebda effett fuq l-AUC u Cmax ta' pioglitazone meta Competact ingħata lil voluntiera b'saħħithom.
English: Tablet core
Maltese: Mikrokristallina ċellulosi
English: 28 tablets
Maltese: 14-il pillola 28 pillola
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Maltese: Disturbi fl-għajnejn Rapporti ta' wara t-tqegħid fis-suq ta' żvilupp jew irkadar ta' edima makulari dijabetika bi tnaqqis fl-akutezza viżiva kienu irrappurtati b'thiazolidinediones, inkluż pioglitazone.
English: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation - by delaying intestinal glucose absorption.
Maltese: - fil-muskolu, billi jżid bi ftit is-sensittività għall-insulina, itejjeb il-ġbir u l-utilizzazzjoni periferika ta' glukożju - billi jittardja l-assorbiment intestinali ta' glukożju.
English: Mon. 1
Maltese: E 1
English: In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged ≥ 65 years compared with those less than 65 years (9.7% compared to 4.0%).
Maltese: kien osservat persentaġġ ogħla ta' pazjenti b'insuffiċjenza tal-qalb f'pazjenti li għandhom ≥ 65 sena meta mqabbla ma'dawk iżgħar minn 65 sena (9.7 % meta mqabbla ma'4.0 %).
English: Renal and urinary disorders haematuria common
Maltese: Disturbi fil-kliewi u fis-sistema urinarja ematurja komuni
English: Competact 15 mg/850 mg film-coated tablets
Maltese: Competact 15 mg/850 mg pilloli miksija b'rita
English: After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Maltese: 500 mg metformin hija ta' madwar 50-60 % f'persuni b'saħħithom.
English: Animal studies have not revealed teratogenic effects.
Maltese: Studji fuq l-annimali ma wrewx effetti teratoġeniċi.
English: comprising 2 packs, each containing 98 film-coated tablets.
Maltese: Komponent ta ' pakkett multiplu li fiħ 2 pakketti, kull wieħed fiħ 98 pillola miksija b'rita.
English: Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Maltese: Studji fil-bniedem jissuġġerixxu li m'hemm l-ebda induzzjoni taċ-ċitokromju prinċipali induċibbli P450, 1A, 2C8/9 u
English: In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
Maltese: Pioglitazone Fi studji dwar l-effett tossiku, l-espansjoni tal-volum tal-plażma permeżz ta' emodiluzzjoni, anemija u ipertrofija kardijaka eċċentrika riversibbli kienet apparenti b'mod konsistenti wara dożaġġ ripetut-fil ġrieden, firien, klieb u xadini.
English: In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
Maltese: Fi provi kliniċi kkontrollati, l-inċidenza ta' rapporti ta' insuffiċjenza tal-qalb b'kura b'pioglitazone kienet l-istess bħall-gruppi ta' kura bil-plaċebo, metformin u sulphonylurea, iżda kienet miżjuda meta wżata f'terapija kombinata ma'linsulina.
English: Adverse reactions reported in double-blind studies and post-marketing experience are listed below as MedDRA preferred term by system organ class and absolute frequency.
Maltese: Reazzjonijiet avversi rrappurtati fi studji doppju għomja u esperjenza ta' wara l-kummerċ huma mniżżla hawn taħt bis-sistema ta' terminu MedDRA ppreferut permeżż tas-sistema tal-klassifika tal-organi u frekwenza assoluta.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Maltese: Metformin huwa biguanide b'effetti anti-ipergliċemiċi, li jnaqqas kemm il-glukożju basali fil-plażma kif ukoll dak ta' wara l-ikel.
English: B. PACKAGE LEAFLET
Maltese: B'KALENDARJU:
English: Stop taking Competact for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Maltese: Waqqaf it-teħid ta' Competact għal żmien qasir jekk għandek kundizzjoni li tista' tkun assoċjata ma' deidratazzjoni (telf sinifikanti ta' fluwidi tal-ġisem) bħal rimettar sever, dijarea, deni, esponiment għal sħana jew jekk tixrob inqas fluwidu min-normal.
English: In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg.
Maltese: Fi provi ta' taħlita, pioglitazone miżjud ma' metformin wassal għall-żieda medja fil-piż fuq medda ta' sena ta' 1.5 kg.
English: Lusal, Produção Químico-Farmacêutica Luso-Alemã, Lda.
Maltese: Lusal, Produção Químico-Farmacêutica LusoAlemã, Lda.
English: Estrada Nacional 249, Km 15 2725-397 Mem Martins Portugal
Maltese: 2725-397 Mem Martins Portugal
English: The wallet with the inserted blister is assembled with a package leaflet (PL) and all components are wrapped together with clear, transparent cellophane wrapping to form the unit pack which prevents the loss of individual components.
Maltese: Il-portafoll bil-folja infilzata jiġi mmuntat b'fuljett ta' tagħrif (PL) u l-komponenti kollha jitgeżwru flimkien b'kisja ta' cellophane irqiq u trasparenti biex jifforma l-pakkett ta' l-unit li jipprevjeni t-telf ta' komponenti individwali.
English: Strength
Maltese: Sveżja
English: The Belanette blister is glued in a carton which is subsequently folded to a wallet configuration.
Maltese: Il-folja ta' Belanette hija mwaħħla bil-kolla ma' kartuna li mbagħad tintlewa f'forma ta' portafoll.
English: Jenapharm GmbH & Co. KG Otto - Schott - Str. 15 D-07745 Jena
Maltese: Għalhekk persuni għomja li jużaw dan il-prodott ikunu jistgħu jiċċekkjaw doppjament it-tagħrif miktub (bil-Braille) fuq il-portafolli tal-kartun bit-tagħrif miksub mit-tabib (waqt iżżjara).
English: Although different observations in respect to readability of the Braille text through the cellophane wrapping have been made by blind users, it is assumed that before use of the product the cellophane wrapping will be removed and therefore blind person will be in a position to identify the product.
Maltese: Għalkemm saru osservazzjonijiet differenti dwar il-possibilità ta' qari tal-kitba bil-Braille mill-kisi tascellophane minn persuni għomja, wieħed jassumi li qabel ma xi ħadd juża l-prodott, dan ineħħi l-kisi tascellophane u għalhekk il-persuna għamja tkun tista' tidentifika l-prodott.
English: 143, Avenue Louise 1050 Brussel
Maltese: Lussemburgu Bayer S.A./N.V. 143, Avenue Louise 1050
English: Germany aida
Maltese: Renju Unit
English: Ελλάδα BGP ΠΡΟΪΟΝΤΑ Μ.Ε.Π.Ε.
Maltese: BGP ΠΡΟΪΟΝΤΑ Μ.Ε.Π.Ε.
English: 224 capsules + 5 inhalers
Maltese: 224 kapsula + 5 inhalers
English: Tear the perforations along the length then width: see Figures (a) and (b).
Maltese: Aqta' tul il-perforazzjonijiet mit-tul u wara mill-wiesa': ara Figuri (a) u (b).
English: • Furosemide or ethacrynic acid, diuretics
Maltese: • Furosemide jew ethacrynic acid, djuretiċi
English: Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Ireland
Maltese: Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 L-Irlanda
English: Mylan IRE Healthcare Limited
Maltese: FIS-SUQ Mylan IRE Healthcare Limited
English: • The active substance is tobramycin.
Maltese: • Is-sustanza attiva hi t-tobramycin.
English: • Wheezing, rales (crackles)
Maltese: • Tħarħir, rales (tfaqqigħ)
English: Gastrointestinal disorders
Maltese: Disturbi gastrointestinali Uġigħ orofarinġali
English: See also section 4.2.
Maltese: Ara wkoll sezzjoni 4.2.
English: See sections 4.4 and 5.1 regarding data in different age groups.
Maltese: Ara sezzjonijiet 4.4 u 5.1 għal informazzjoni dwar gruppi ta' etajiet differenti.
English: Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius.
Maltese: Tobramycin hi antibijotiku aminoglikoside prodott minn Streptomyces tenebrarius.
English: • Amphotericin B, cefalotin, polymyxins (used to treat microbial infections), ciclosporin, tacrolimus (used to reduce the activity of immune system).
Maltese: • Amphotericin B, cefalotin, polymyxins (użati biex jikkuraw infezzjonijiet b'mikrobi), ciclosporin, tacrolimus (użati biex inaqqsu l-attività tas-sistema immuna).
English: BGP Product s. r.o.
Maltese: Slovenská republika BGP Product s. r.o.
English: See also information on clinical benefit and tolerability in sections 4.4, 4.8 and 5.1.
Maltese: Ara wkoll informazzjoni dwar il-benefiċċju kliniku u t-tolerabbilità f'sezzjonijiet 4.4, 4.8 u 5
English: BGP Products s.r.o.
Maltese: Česká republika BGP Products s.r.o.
English: 4 capsules = 1 dose
Maltese: 4 kapsuli = doża waħda
English: The hard capsules are supplied in PVC/PA/Alu/PVC- PET/Alu blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-kapsuli iebsa jiġu f'folji tal-PVC/PA/Alu/PVC- PET/Alu.
English: A difference in FEV1 response by age was noted.
Maltese: Kienet innutata differenza fl-FEV1 skont l-età.
English: Other medicinal products that have been reported to increase the potential toxicity of parenterally administered aminoglycosides include: - amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity); - platinum compounds (risk of increased nephrotoxicity and ototoxicity); - anticholinesterases, botulinum toxin (neuromuscular effects).
Maltese: Prodotti mediċinali oħrajn li kienu rrappurtati li jżidu l-potenzjal ta' tossiċità ta' aminoglikosidi mogħtija parenteralment jinkludu: - amfoteriċina B, ċefalotina, ċiklosperina, takrolimus, polimiksin (riskju ta' żieda tan nefrotossiċità); - komponenti tal-platinu (riskju ta' żieda tan-nefrotossiċità u l-ototossiċità); - antikolinesterasi, tossina botulinika (effetti newromuskolari).
English: • After this if the capsule is still full and appears not to be pierced, replace the inhaler with the reserve inhaler and repeat Steps 2, 3, 6, 7, 8, 9 and 10.
Maltese: • Wara dan jekk il-kapsula xorta għadha mimlija u tidher li ma ttaqqbitx, biddel l-inhaler mal-inhaler żejjed u rrepeti Stadji 2, 3, 6, 7, 8, 9 u 10.
English: Mylan Healthcare GmbH Tel: +49 6172 888 01
Maltese: Deutschland Mylan Healthcare GmbH Tel: +49 6172 888 01
English: If the capsule does not look pierced:
Maltese: Jekk il-kapsula ma tidhirx imtaqqba:
English: • So for each remaining capsule, repeat steps 5,6, 7, 8, 9,
Maltese: • Għaldaqstant għal kull kapsula li fadallek, irrepeti Stadji 5, 6, 7, 8, 9, 10 u 11.
English: One capsule contains 28 mg tobramycin.
Maltese: Kull kapsula iebsa fiha 28 mg tobramycin.
English: Tél: +33 1 56 64 10 70
Maltese: Mylan Medical SAS Tél: +33 1 56 64 10 70
English: Sulfuric acid (for pH adjustment)
Maltese: Sulfuric acid (għall-aġġustament tal-pH)
English: Pseudomonas aeruginosa Haemophilus influenzae Staphylococcus aureus Insusceptible Burkholderia cepacia Stenotrophomonas maltophilia Alcaligenes xylosoxidans
Maltese: Burkholderia cepacia Stenotrophomonas maltophilia Alcaligenes xylosoxidans
English: Mylan Healthcare d.o.o.
Maltese: Mylan Healthcare B.V.
English: Tear along the perforations of the capsule card lengthwise then widthwise, as indicated in pictures (1) and (2).
Maltese: Aqta' matul il-perforazzjonijiet tal-folja bil-kapsuli mattul u mal-wiesgħa, kif indikat fi stampi (1) u (2).
English: Aphonia
Maltese: Afonija
English: Inhalation powder, hard capsules Multipack: 224 capsules (4 packs of 56 + 1 inhaler) + reserve inhaler
Maltese: Pakkett b'ħafna: 224 kapsula (4 pakketti ta' 56 + inhaler wieħed) + inhaler żejjed
English: Treatment with TOBI Podhaler for 28 days resulted in a statistically significant reduction in P. aeruginosa sputum density (-1.61 log10 CFUs), as did the nebuliser solution (-0.77 log10 CFUs).
Maltese: Il-kura b'TOBI Podhaler għal 28 jum irriżulta fi tnaqqis statistikament sinnifikanti ta' densità talisputum P. aeruginosa (-1.61 log10 CFUs), kif ġara wkoll bis-solizzjoni fin-nebulizzatur (-0.77log10
English: • Do not swallow TOBI Podhaler capsules.
Maltese: • Tiblax il-kapsuli TOBI Podhaler.
English: Contains 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride and sulphuric acid (for pH adjustment).
Maltese: Fiha 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride u sulphuric acid (għallaġġustament tal-pH).
English: • Take a few normal breaths away from the inhaler.
Maltese: • Ħu ftit nifsijiet normali mhux fl-inhaler.
English: TOBI Podhaler contains a medicine called tobramycin which is an antibiotic.
Maltese: TOBI Podhaler fih mediċina msejħa tobramycin li hija antibijotiku.
English: In a 6-month (3 treatment cycles) study of TOBI Podhaler versus tobramycin nebuliser solution, which included a majority of tobramycin-experienced adult patients with chronic pulmonary P. aeruginosa infection, the suppression of sputum P. aeruginosa density was similar across age groups in both arms; however the increase from baseline FEV1 was larger in younger age groups (6 - <20) than in the adult subgroup (20 years and older) in both arms.
Maltese: Fi studju li dam 6 xhur (3 ċikli ta' kura) b'TOBI Podhaler kontra s-soluzzjoni tan-nebulizzatur tobramycin li kien jinkludi maġġoranza ta' pazjenti adulti b'infezzjoni pulmonari kronika b'P. aeruginosa b'esperjenza ta' tobramycin, it-trażżin tad-densità ta' P. aeruginosa fl-isputum kien listess fost l-etajiet differenti fiż-żewġ gruppi; madanakollu ż-żieda fl-FEV1 mil-linja bażi kienet akbar fost il-gruppi ta' età iżgħar (6 - <20) milli kienet fis-sottogrupp tal-adulti (20 sena jew aktar) fiż-żewġ gruppi.
English: In the placebo controlled study, patients were aged 6 - ≤22 years with an FEV1 at screening of between 25% and 84% of predicted normal values for their age, sex and height based upon Knudson criteria.
Maltese: Fl-istudju kkontrollat bi plaċebo, il-pazjenti kellhom 6 - ≤22 sena b'FEV1 waqt l-iskrining ta' bejn 25% u 84% tal-valuri normali mbassra għall-età, is-sess u t-tul tagħhom skont il-kriterji Knudson.
English: Suppression of sputum P. aeruginosa density was similar across age groups in both arms.
Maltese: It-tneħħija tad-densità ta'' l-isputum P. aeruginosa kien simili fost il-gruppi ta' etajiet fiżżewġ partijiet.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Aminoglycoside antibacterials, ATC Code: J01GB01
Maltese: Antibatteriċi għal użu sistemiku, Antibatteriċi aminoglikosidi, Kodiċi ATC:
English: Data in different age groups
Maltese: Informazzjoni minn gruppi ta' etajiet differenti
English: 56 capsules and 1 inhaler
Maltese: 56 kapsula u inhaler wieħed
English: Inhalation powder, hard capsules Multipack: 448 capsules (2 packs of 224 + 5 inhalers)
Maltese: U KONTENUT Trab li jittieħed man-nifs, kapsuli ibsin Pakkett b'ħafna: 448 kapsula (2 pakketti ta' 224 + 5 inhalers)
English: A population pharmacokinetic analysis for TOBI Podhaler in cystic fibrosis patients aged 6 to 66 years estimated the apparent serum clearance of tobramycin to be 14 litres/h.
Maltese: Skont analiżi farmakokinetika tal-popolazzjoni fejn jidħol TOBI Podhaler f'pazjenti b'fibrożi ċistika ta' bejn 6 u 66 sena kien stmat li t-tneħħija evidenti ta' tobramycin fis-serum kienet ta' 14 litri/siegħa.
English: See also section 4.2 and “Monitoring of serum tobramycin concentrations” below.
Maltese: Ara wkoll sezzjoni 4.2 “Monitoraġġ tal-konċentrazzjonijiet ta' tobramycin fis-serum” hawn taħt.
English: Susceptibility
Maltese: Suxxetibilità
English: Dyspnoea
Maltese: Disfonja
English: 224 (4 x 56) capsules and 5 inhalers (monthly multipack) 448 (8 x 56) capsules and 10 inhalers (2 x monthly multipack wrapped in foil) Not all pack sizes may be marketed.
Maltese: 224 (4 x 56) kapsula u 5 inhalers (pakkett b'ħafna għal xahar) 448 (8 x 56) kapsula b'10 inhalers (żewġ pakketti b'ħafna għal xahar imgeżwrin fil-fojl) Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Hearing loss and tinnitus were reported by patients in the TOBI Podhaler clinical studies (see section 4.8).
Maltese: It-telf tas-smigħ u ż-żanżin fil-widnejn kienu rrappurtati minn pazjenti waqt studji kliniċi b'TOBI Podhaler (ara sezzjoni 4.8).
English: Treatment with TOBI Podhaler for 28 days resulted in a statistically significant reduction in P. aeruginosa sputum density (mean difference with placebo about 2.70 log10 in colony forming units/CFUs).
Maltese: Kura b' TOBI Podhaler għal 28 jum irriżulta fi tnaqqis statistikmaent sinnifikanti fid-densità tal-isputum P. aeruginosa (differenza miedja bil-plaċebo ta' madwar 2.70 log10 f'unitajiet li jiffurmaw kolonji)
English: REMEMBER:
Maltese: FTAKAR:
English: The proportions of patients requiring hospitalisation for respiratory events were 24.4% with TOBI Podhaler and 22.0% with TOBI nebuliser solution.
Maltese: Il-proporzjoni ta' pazjenti li kienu jeħtieġu li jiddaħħlu lisptar għal każijiet respiratorji kienu 24.4% b'TOBI Podhaler u 22.0% b'soluzzjoni tan-nebulizzatur
English: Over half of the patients in both the TOBI Podhaler and TOBI nebuliser solution treatment groups received new (additional) anti-pseudomonal antibiotics (64.9% and 54.5% respectively, the difference consisting mainly of oral ciprofloxacin use).
Maltese: Iktar min-nofs il-pazjenti kemm fil-gruppi b'TOBI Podhaler kif ukoll għal dawk bil-kura tas-soluzzjoni bin-nebulizzatur TOBI rċevew antibijotiċi ġodda (addizzjonali) anti-psewdonomali (64.9% u 54.5% rispettivament, bid-differenza tikkonsisti prinċipalment fl-użu orali ta' ciprofloxacin).
English: A population pharmacokinetic analysis for TOBI Podhaler in cystic fibrosis patients estimated the apparent volume of distribution of tobramycin in the central compartment to be 84.1 litres for a typical CF patient.
Maltese: Skont analiżi farmakokinetika tal-popolazzjoni fejn jidħol TOBI Podhaler f'pazjenti b'fibrożi ċistika kien stmat li l-volum evidenti ta' distribuzzjoni ta' tobramycin fil-kompartiment ċentrali kien ta' 84.1 litri għal pazjent b'fibrożi ċistika tipika.
English: Safety and efficacy have not been studied in patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonised with Burkholderia cepacia.
Maltese: Is-sigurtà u l-effikaċja ma ġewx studjati f'pazjenti b'volum maħsub tan-nifs sfurzat 'il barra f'sekonda (FEV1) ta' <25% jew >75%, jew f'pazjenti kkolonizzat b'Burkholderia cepacia.