FrancophonIA/ELRC3.0 huggingface dataset:
English: In the scientific literature, cholic acid treatment was shown to reduce the amount of abnormal bile acids in patients, to restore the normal functions of the liver and to help delay or prevent the need for a liver transplant.
Maltese: Fil-letteratura xjentifika, il-kura bl-aċidu koliku ntweriet li tnaqqas l-ammont ta' aċidi biljari anormali fil-pazjenti, biex iġġib lura l-funzjonijiet normali tal-fwied u biex tgħin sabiex tittardja jew tevita lħtieġa ta' trapjant tal-fwied.
English: This helps to decrease the production of abnormal bile acids and contributes to the normal activity of bile in the digestive system, thereby relieving the symptoms of the condition.
Maltese: Dan jgħin sabiex titnaqqas il-produzzjoni ta' aċidi biljari anormali u jikkontribwixxi għall-attività normali tal-bila fis-sistema diġestiva, u b'hekk itaffi s-sintomi tal-kondizzjoni.
English: Orphacol is a medicine containing cholic acid, a substance found in the bile which is used to digest fats.
Maltese: Orphacol huwa mediċina li fiha l-aċidu koliku, sustanza li tinstab fil-bila li tintuża għad-diġestjoni taxxaħmijiet.
English: See section 4.4: “Adrenal function”.
Maltese: Ara sezzjoni 4.4: “Funzjoni adrenali”.
English: Relative Risk (95% confidence intervals)
Maltese: Riskju Relattiv (intervalli ta' kunfidenza ta' 95%)
English: 2 years.
Maltese: 2 sentejn.
English: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG
Maltese: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tel/Tél:
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35 IDA Industrial Park
Maltese: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35 IDA Industrial Park Cork Road
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland
Maltese: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, L-Irlanda
English: Teva Eesti esindus UAB Sicor Biotech Eesti
Maltese: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
English: salmeterol placebo
Maltese: salmeterol plaċebo
English: Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles).
Maltese: Arritmiji kardijaċi (inklużi takikardija supraventrikulari u ekstrasistoli).
English: A 4-unit decrease is considered clinically relevant.
Maltese: Tnaqqis ta' 4 unitajiet huwa kkunsidrat klinikament rilevanti.
English: βeta 2 adrenoreceptor agonists
Maltese: Agonisti tar-riċetturi βeta 2 adrenerġiċi
English: • Xanthine medicines such as aminophylline and theophylline.
Maltese: • Mediċini xanthine bħal aminophylline u theophylline.
English: Vision, blurred (see also section 4.4)
Maltese: Vista, imċajpra (ara wkoll sezzjoni 4.4)
English: Parodoxical bronchospasm
Maltese: Bronkospażmu paradossali
English: <2D barcode carrying the unique identifier included.>]
Maltese: <barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: Subjects were randomised 1:1 to salmeterol/FP 50/250 (total ITT n=776) or salmeterol (total ITT n=778).
Maltese: L-individwi kienu randomised 1:1 għal salmeterol/FP 50/250 (ITT totali n=776) jew salmeterol (ITT totali n=778).
English: The main pathway is metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4.
Maltese: Ir-rotta prinċipali hija metaboliżmu għall-metabolit inattiv carboxylic acid, permezz tal-enzima cytochrome P450 CYP3A4.
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Aerivio Spiromax contains lactose').
Maltese: - Is-sustanza l-oħra hija lactose monohydrate (ara sezzjoni 2 taħt ‘Aerivio Spiromax fih lactose').
English: FOIL
Maltese: FOJL
English: • Pneumonia and bronchitis (lung infection).
Maltese: • Pulmonite u bronkite (infezzjoni fil-pulmun).
English: The recommended dose is:
Maltese: Dożi rakkomandati:
English: (For Poland only) Teva Operations Poland Sp. z o.o.
Maltese: (For Poland only) Teva
English: • Beta blockers (such as atenolol, propranolol and sotalol).
Maltese: • Imblokkaturi tar-riċetturi Beta (bħal atenolol, propranolol u sotalol).
English: Potassium replacement should be considered.
Maltese: Għandu jiġi kkunsidrat sostituzzjoni tal-potassium.
English: • For inhalations remaining from 20 downwards to ‘8', ‘6', ‘4', ‘2' the numbers are displayed in red on a white background.
Maltese: • Għal inalazzjonijiet li jifdal minn 20 l-isfel sa ‘8', ‘6', ‘4', ‘2' in-numri huma murija bl-aħmar fuq sfond abjad.
English: Percentage of Patients Attaining *Well Controlled (WC) and **Totally Controlled (TC) Asthma over
Maltese: Persentaġġ ta' Pazjenti li Kisbu Ażżma *Ikkontrollata Tajjeb (WC - Well Controlled) u **Ikkontrollata Totalment (TC - Totally Controlled) fuq 12-il xahar
English: After opening the foil wrap: 3 months.
Maltese: Wara li tinfetaħ il-kisja tal-fojl: 3 xhur.
English: Aerivio Spiromax contains two medicines, salmeterol and fluticasone propionate:
Maltese: Aerivio Spiromax fih żewġ mediċini, salmeterol u fluticasone propionate:
English: Chronic Obstructive Pulmonary Disease (COPD)
Maltese: chronic obstructive pulmonary disease).
English: • Salmeterol is a long-acting bronchodilator.
Maltese: • Salmeterol huwa bronkodilatur li jaħdem fit-tul.
English: Teva Pharmaceuticals Polska Sp. z o.o.
Maltese: Teva Operations Poland Sp. z.o.o. ul.
English: Paediatric population
Maltese: Popolazzjonijiet etniċi
English: Plasma protein binding is 91%.
Maltese: It-twaħħil mal-proteini tal-plażma huwa 91%.
English: • Medicines to treat infections (such as ritonavir, ketoconazole, itraconazole and erythromycin).
Maltese: • Mediċini biex jittrattaw infezzjonijiet (bħal ritonavir, ketoconazole, itraconazole u erythromycin).
English: Key findings from SMART: primary endpoint Patient group
Maltese: Sejbiet ewlenin minn SMART: punt tat-tmiem primarju Grupp ta' pazjent
English: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Maltese: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, L-Olanda
English: Number of primary endpoint events /number of patients
Maltese: Numru ta' avvenimenti tal-punt tat-tmiem primarju/numru ta' pazjenti
English: System Organ Class Adverse reaction
Maltese: Klassi tas-Sistemi u tal-Organi
English: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects.
Maltese: Ko-trattament b'inibituri CYP3A, inklużi prodotti li fihom il-cobicistat, huwa mistenni li jżid ir-riskju ta 'effetti sekondarji sistemiċi.
English: The drug/mucosal contact parts of the inhaler are made of acrylonitrile butadiene styrene (ABS), polyethylene (PE) , and polypropylene (PP).
Maltese: Il-partijiet tal-inalatur li jmissu mal-mediċina/mukuża huma magħmula minn acrylonitrile butadiene styrene (ABS), polyethylene (PE), u polypropylene (PP).
English: COPD patients with a baseline (pre-bronchodilator) FEV1 <60% of predicted normal were randomised to double-blind medication.
Maltese: Pazjenti b'COPD b'FEV1 fil-linja bażi (qabel teħid ta' bronkodilatur) <60% tan-normal imbassar ġew randomised għal medikazzjoni double-blind.
English: • Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.
Maltese: • Fluticasone propionate huwa kortikosterojd li jnaqqas in-nefħa u l-irritazzjoni fil-pulmuni.
English: Pneumonia-related events were reported for 55 (7%) subjects in the salmeterol/fluticasone propionate 50/250 micrograms twice daily group and 25 (3%) in the salmeterol group.
Maltese: Avvenimenti relatati ma' pulmonite kienu rrappurtati għal 55 (7%) individwu fil-grupp ta' salmeterol/fluticasone propionate 50/250 mikrogramma darbtejn kuljum u għal 25 (3%) fil-grupp ta' salmeterol.
English: Rarely, Aerivio Spiromax may cause cardiac arrhythmias e.g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses.
Maltese: Rarament, Aerivio Spiromax jista' jikkawża arritmiji kardijaċi eż. takikardija supraventrikulari, ekstrasistoli u fibrillazzjoni tal-atriju, u tnaqqis temporanju ħafif fil-potassium fis-serum b'dożi terapewtiċi għoljin.
English: Fluticasone propionate is cleared very rapidly from the systemic circulation.
Maltese: Fluticasone propionate jitneħħa malajr ħafna miċ-ċirkolazzjoni sistemika.
English: Swensweg 5, 2031 GA Haarlem, Netherlands
Maltese: Swensweg 5, 2031 GA Haarlem, L-Olanda
English: Data from a large clinical trial (the Salmeterol Multi-Center Asthma Research Trial, SMART) suggested African-American patients were at increased risk of serious respiratory-related events or deaths when using salmeterol compared with placebo (see section 5.1).
Maltese: Data minn prova klinika kbira (Prova ta' Riċerka Dwar l-Ażżma b'Aktar Minn Ċentru Wieħed b'Salmeterol, SMART [Salmeterol Multi-center Asthma Research Trial]) issuġġeriet li pazjenti Amerikani-Afrikani kellhom riskju akbar ta' avvenimenti serji relatati mar-respirazzjoni jew imwiet meta jużaw salmeterol meta mqabbel ma' plaċebo (ara sezzjoni 5.1).
English: • Overactive thyroid gland
Maltese: • Glandola tat-tirojde attiva żżejjed
English: Aerivio Spiromax 50 micrograms/500 micrograms
Maltese: Aerivio Spiromax 50 µg/500 µg
English: There is also an increased risk of systemic undesirable effects when combining fluticasone propionate with other potent CYP3A inhibitors (see section 4.5).
Maltese: Hemm ukoll żieda fir-riskju ta' effetti sistemiċi mhux mixtieqa meta fluticasone propionate jiġi kkombinat ma' inibituri qawwija oħra ta' CYP3A (ara sezzjoni 4.5).
English: Depression, aggression (predominantly in children)
Maltese: Depressjoni, aggressjoni (l-aktar fit-tfal)
English: Aerivio Spiromax is not indicated for use in children and adolescents under the age of 18 years (see Section 4.2).
Maltese: Aerivio Spiromax mhux indikat għal użu fi tfal u adolexxenti taħt l-età ta' 18-il sena (ara sezzjoni 4.2).
English: Cases of Cushing's syndrome and adrenal suppression have been reported.
Maltese: Ġew irrappurtati każijiet tas-sindrome ta' Cushing u soppressjoni adrenali.
English: Each dose contains approximately 10 milligrams of lactose (as monohydrate).
Maltese: Kull doża fiha madwar 10 milligrammi ta' lactose (bħala monohydrate).
English: For pharmacokinetic purposes each component can be considered separately.
Maltese: Għall-finijiet farmakokinetiċi kull komponent jista' jiġi kkunsidrat b'mod separat.
English: The estimated 3-year probability of having pneumonia reported as an adverse event was 12.3% for placebo, 13.3% for salmeterol, 18.3% for FP and 19.6% for salmeterol/fluticasone propionate (hazard ratio for salmeterol/fluticasone propionate vs placebo: 1.64, 95% CI: 1.33 to 2.01, p<0.001).
Maltese: Stima tal-probabbiltà ta' 3 snin li wieħed ikollu pulmonite irrappurtata bħala avveniment avvers kienet ta' 12.3% għall-plaċebo, 13.3% għal salmeterol, 18.3% għal FP u 19.6% għal salmeterol/fluticasone propionate (proporzjon ta' periklu għal salmeterol/fluticasone propionate kontra plaċebo: 1.64, CI ta' 95%: 1.33 sa 2.01, p<0.001).
English: Possible systemic effects in these age groups include Cushing's syndrome, Cushingoid features, adrenal suppression and growth retardation in children and adolescents (see section 4.4).
Maltese: Effetti sistemiċi possibbli f'dawn il-gruppi ta' età jinkludu s-sindrome ta' Cushing, karatteristiċi Cushingoid, soppressjoni adrenali u ttardjar tat-tkabbir fi tfal u adolexxenti (ara sezzjoni 4.4).
English: Aerivio Spiromax is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Maltese: Aerivio Spiromax mhux indikat għal użu fit-tfal, b'età ta' 12-il sena u inqas jew adolexxenti b'età ta' 13 sa 17-il sena.
English: In a population pharmacokinetic analysis from 9 controlled clinical trials of 350 patients with asthma aged 4 to 77 years (174 patients 4 to 11 years of age) higher fluticasone propionate systemic exposure following treatment with salmeterol/fluticasone propionate inhalation powder 50/100 compared with fluticasone propionate inhalation powder 100 was seen.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni minn 9 provi kliniċi kkontrollati ta' 350 pazjent bl-ażżma ta' età minn 4 snin sa 77 sena (174 pazjent ta' età minn 4 snin sa 11-il sena) kien osservat esponiment sistemiku għal fluticasone propionate ogħla wara trattament b'salmeterol/fluticasone propionate 50/100 trab li jittieħed man-nifs meta mqabbel ma' fluticasone propionate 100 trab li jittieħed man-nifs.
English: The disposition of fluticasone propionate is characterised by high plasma clearance (1150 mL/min), a large volume of distribution at steady-state (approximately 300 L) and a terminal half-life of approximately 8 hours.
Maltese: Id-dispożizzjoni ta' fluticasone propionate hija kkaratterizzata minn tneħħija għolja mill-plażma (1150 mL/min), volum kbir ta' distribuzzjoni fi stat fiss (bejn wieħed u ieħor 300 L) u half-life terminali ta' madwar 8 sigħat.
English: Peak Inspiratory Flow Rate through the Spiromax Device A randomised, open-label cross-over study was performed in children and adolescents with asthma (aged 417 years), adults with asthma (aged 18-45 years), adults with chronic obstructive pulmonary disease (COPD) (aged older than 55 years) and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device (containing placebo).
Maltese: Rata Massima ta' Fluss Inspiratorju permezz tal-Apparat Spiromax Twettaq studju randomised, open-label u cross-over fi tfal u adolexxenti bl-ażżma (età ta' 4-17-il sena), f'adulti bl-ażżma (età ta' 18-45 sena), f'adulti b'marda kronika ostruttiva tal-pulmun (COPD - chronic obstructive pulmonary disease) (età ta' aktar minn 55 snin) u voluntiera f'saħħithom (età ta' 18-45 sena) biex tiġi evalwata r-rata massima ta' fluss inspiratorju (PIFR - peak inspiratory flow rate) u parametri oħra relatati mal-inalazzjoni wara inalazzjoni minn apparat Spiromax (li jkun fih plaċebo) meta mqabbel ma' inalazzjoni minn apparat għat-teħid man-nifs b'dożi multipli ta' trab niexef diġà fuq is-suq (li fih plaċebo).
English: Hence, clinically significant drug interactions mediated by fluticasone propionate
Maltese: Għalhekk, interazzjonijiet klinikament sinifikanti tal-mediċina medjati minn fluticasone propionate mhumiex probabbli.
English: • Headache - this usually gets better as treatment continues.
Maltese: • Uġigħ ta' ras - dan normalment jittaffa kif jitkompla t-trattament.
English: • Chronic obstructive pulmonary disease (COPD), to reduce the number of flare ups of symptoms.
Maltese: • Marda kronika ostruttiva tal-pulmun (COPD - chronic obstructive pulmonary disease), biex tnaqqas in numru ta' taħrix tas-sintomi.
English: Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Maltese: Teva B.V., Swensweg 5, 2031 GA Haarlem, l-Olanda
English: There were no differences in safety parameters between the two treatment arms.
Maltese: Ma kien hemm l-ebda differenza fil-parametri tas-sigurtà bejn iż-żewġ gruppi ta' trattament.
English: Risk in bold figures is statistically significant at the 95% level.
Maltese: Riskju mniżżel b'tipa grassa huwa statistikament sinifikanti fil-livell ta' 95%.
English: Aerivio Spiromax is not available on the market at strengths lower than 50/500 microgram.
Maltese: Aerivio Spiromax mhuwiex disponibbli fis-suq bħala qawwiet inqas minn 50/500 mikrogramma.
English: Patients using inhaled steroids Patients not using inhaled steroids African-American patients (Risk in bold is statistically significant at the 95% level.)
Maltese: Pazjenti Amerikani-Afrikani (Riskju mniżżel b'tipa grassa huwa statistikament sinifikanti fil-livell ta' 95%.)
English: This translates to a reduction in the rate of moderate to severe exacerbations of 25% (95% CI: 19% to 31%; p<0.001) compared with placebo, 12% compared with salmeterol (95% CI: 5% to 19%, p=0.002) and 9% compared with FP (95% CI: 1% to 16%, p=0.024).
Maltese: Dan jittraduċi għal tnaqqis fir-rata ta' episodji ta' rkadar moderat sa sever ta' 25% (CI ta' 95%: 19% sa 31%; p<0.001) meta mqabbel mal-plaċebo, 12% meta mqabbel ma' salmeterol (CI ta' 95%: 5% sa 19%, p=0.002) u 9% meta mqabbel ma' FP (CI ta' 95%: 1% sa 16%, p=0.024). Salmeterol u FP naqqsu b'mod sinifikanti r-rati ta' irkadar meta mqabbel ma' plaċebo b'15% (CI ta' 95%: 7% sa 22%; p<0.001) u 18% (CI ta' 95%: 11% sa 24%; p<0.001) rispettivament.
English: Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see Paediatric population sub-heading below for information on the systemic effects of inhaled corticosteroids in children and adolescents).
Maltese: Effetti sistemiċi possibbli jinkludu s-sindrome ta' Cushing, karatteristiċi Cushingoid, soppressjoni adrenali, tnaqqis fid-densità tal-minerali tal-għadam, katarretti u glawkoma u aktar rari, firxa ta' effetti psikoloġiċi jew ta' mġiba li jinkludu iperattività psikomotorja, disturbi fl-irqad, ansjetà, depressjoni jew aggressjoni (speċjalment fit-tfal) (ara s-sotto intestatura Popolazzjoni pedjatrika hawn taħt għal tagħrif dwar l-effetti sistemiċi ta' kortikosterojdi li jittieħdu man-nifs fit-tfal u l-adolexxenti).
English: The Salmeterol Multi-center Asthma Research Trial (SMART)
Maltese: Il-Prova ta' Riċerka Dwar l-Ażżma b'Aktar Minn Ċentru Wieħed b'Salmeterol (SMART - Salmeterol Multicenter Asthma Research Trial)
English: Low dose ICS ( ≤500 micrograms BDP or
Maltese: L-ebda ICS (SABA waħdu) ICS ta' doża baxxa (≤500 mikrogramma BDP jew ekwivalenti/jum)
English: How to store Aerivio Spiromax
Maltese: Preparazzjoni ta' Aerivio Spiromax
English: 1/10), uncommon (1/1000 to 1/100), rare (1/10,000 to <1/1000) and not known (frequency cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: 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) u mhux magħruf (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli).
English: SMART was a multi-centre, randomised, double blind, placebo-controlled, parallel group 28-week study in the US which randomised 13,176 patients to salmeterol (50 micrograms twice daily) and 13,179 patients to placebo in addition to the patients' usual asthma therapy.
Maltese: SMART kien studju ta' 28 ġimgħa b'aktar minn ċentru wieħed, randomised, double blind, ikkontrollat bilplaċebo, bi grupp parallel fl-Istati Uniti fejn 13,176 pazjent kienu randomised għal salmeterol (50 mikrogramma darbtejn kuljum) u 13,179 pazjent għal plaċebo flimkien ma' terapija tas-soltu għallażżma tal-pazjent.
English: [3%] vs 1 [<1%]) and a similar incidence of inhaled corticosteroid related adverse events (e.g. oral candidiasis - 6 [6%] vs 16 [8%], hoarseness - 2 [2%] vs 4 [2%]) compared with one inhalation twice daily.
Maltese: L-istudju wera li rduppjar tal-inalazzjonijiet ta' kull qawwa ta' salmeterol/fluticasone propionate sa 14-il ġurnata irriżulta f'żieda żgħira f'avvenimenti avversi relatati ma' agonisti tar-riċetturi β (rogħda - pazjent wieħed [1%] kontra 0, palpitazzjonijiet - 6 [3%] kontra 1 [<1%], bugħawwieġ fil-muskoli - 6 [3%] kontra 1 [<1%]) u inċidenza simili ta' avvenimenti avversi relatati ma' kortikosterojd meħud man-nifs (eż. kandidjasi orali - 6 [6%] kontra 16 [8%], ħanqa - 2 [2%] kontra 4 [2%]) meta mqabbel ma' inalazzjoni waħda darbtejn kuljum.
English: The percentage of patients who died within 3 years due to COPD-related causes was 6.0% for placebo, 6.1% for salmeterol, 6.9% for FP and 4.7% for salmeterol/fluticasone propionate.
Maltese: Il-persentaġġ ta' pazjenti li mietu fi żmien 3 snin minħabba kawżi relatati ma' COPD kien ta' 6.0% għallplaċebo, 6.1% għal salmeterol, 6.9% għal FP u 4.7% għal salmeterol/fluticasone propionate.
English: Co-treatment with other potent CYP3A inhibitors, such as itraconazole, and moderate CYP3A inhibitors, such as erythromycin, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic undesirable effects.
Maltese: Trattament fl-istess waqt b'inibituri potenti oħra ta' CYP3A, bħal itraconazole, u inibituri moderati ta' CYP3A, bħal erythromycin, wkoll huwa mistenni li jżid l-esponiment sistemiku għal fluticasone propionate u r-riskju ta' effetti mhux mixtieqa sistemiċi.
English: The mean number of moderate to severe exacerbations per year was significantly reduced with salmeterol/fluticasone propionate (FP) as compared with treatment with salmeterol, FP and placebo (mean rate in the salmeterol/fluticasone propionate group 0.85 compared with 0.97 in the salmeterol group, 0.93 in the FP group and 1.13 in the placebo).
Maltese: In-numru medju ta' episodji ta' rkadar moderat sa sever kull sena kien imnaqqas b'mod sinifikanti b'salmeterol/fluticasone propionate (FP) meta mqabbel ma' trattament b'salmeterol, FP u plaċebo (rata medja fil-grupp ta' salmeterol/fluticasone propionate ta' 0.85 meta mqabbel ma' 0.97 fil-grupp ta' salmeterol, 0.93 fil-grupp ta' FP u 1.13 bil-plaċebo).
English: Medium dose ICS (>500 to 1000 micrograms
Maltese: ICS ta' doża medja (>500 sa
English: Behavioural changes, including psychomotor hyperactivity and irritability (predominantly in
Maltese: Tibdil fl-imġiba, inkluż attività psikomotorja eċċessiva u irritabilità (l-aktar fit-tfal)
English: There was no increase in pneumonia related deaths; deaths while on treatment that were adjudicated as primarily due to pneumonia were 7 for placebo, 9 for salmeterol, 13 for FP and 8 for salmeterol/fluticasone propionate.
Maltese: Ma kien hemm l-ebda żieda ta' imwiet relatati ma' pulmonite; imwiet waqt it-trattament li kienu aġġudikati bħala primarjament ikkawżati minn pulmonite kienu 7 għall-plaċebo, 9 għal salmeterol, 13 għal FP u 8 għal salmeterol/fluticasone propionate.
English: There was no significant difference in probability of bone fracture (5.1% placebo, 5.1% salmeterol, 5.4% FP and 6.3% salmeterol/fluticasone propionate; hazard ratio for salmeterol/fluticasone propionate vs placebo: 1.22, 95%
Maltese: Ma kien hemm l-ebda differenza sinifikanti fil-probabbiltà ta' ksur fl-għadam (5.1% plaċebo, 5.1% salmeterol, 5.4% FP u 6.3% salmeterol/fluticasone propionate; proporzjon ta' periklu għal salmeterol/fluticasone propionate kontra plaċebo: 1.22, CI ta' 95%: 0.87 sa 1.72, p=0.248.
English: Salmeterol acts locally in the lung therefore plasma levels are not an indication of therapeutic effects.
Maltese: Salmeterol jaġixxi lokalment fil-pulmun għalhekk il-livelli fil-plażma mhumiex indikazzjoni ta' effetti terapewtiċi.
English: Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should therefore be avoided unless the benefits outweigh the potentially increased risk of systemic undesirable effects of salmeterol treatment (see section 4.5).
Maltese: Trattament flimkien ma' ketoconazole jew inibituri potenti oħra ta' CYP3A4 għalhekk għandu jiġi evitat sakemm il-benefiċċji ma jkunux akbar miż-żieda potenzjali fir-riskju ta' effetti sistemiċi mhux mixtieqa ta' trattament b'salmeterol (ara sezzjoni 4.5).
English: Respiratory tract infections
Maltese: Infezzjonijiet fl-apparat respiratorju
English: A double blind, randomised, parallel group study in 318 patients with persistent asthma aged ≥18 years evaluated the safety and tolerability of administering two inhalations twice daily (double dose) of salmeterol/fluticasone propionate for two weeks.
Maltese: Studju double blind, randomised bi grupp parallel fuq 318-il pazjent b'ażżma persistenti b'età ta' ≥18-il sena evalwa s-sigurtà u t-tollerabilità ta' għoti ta' żewġ inalazzjonijiet darbtejn kuljum (doża doppja) ta' salmeterol/fluticasone propionate għal ġimagħtejn.
English: Potentially serious hypokalaemia may result from β2 agonist therapy.
Maltese: Ipokalimja potenzjalment serja tista' tirriżulta minn terapija b'agonist tar-riċetturi β2.
English: Mechanism of action and pharmacodynamic effects
Maltese: .1 Proprjetajiet farmakodinamiċi