FrancophonIA/ELRC3.0 huggingface dataset:
English: In repeat dose toxicology studies in rats, adverse effects (e.g. thickening of epiphyseal plates, lesions of the incisors) were mostly related to the mechanism of action (i.e. VEGFR-2 inhibition) of nintedanib.
Maltese: Fi studji tossikoloġiċi dwar doża ripetuta fil-firien, l-effetti avversi (eż. tħaxxin talepiphyseal plates, leżjonijiet tal-incisors) kienu fil-biċċa l-kbira tagħhom relatati mal-mekkaniżmu ta' azzjoni (i.e. inibizzjoni ta' VEGFR-2) ta' nintedanib.
English: Ofev 150 mg capsules are brown-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “150”.
Maltese: Ofev 150 mg kapsuli huma kapsuli tal-ġelatina ratba ta' kulur kannella, opaki, tawwalin, stampati fuq naħa waħda bl-iswed bis-simbolu tal-kumpanija Boehringer Ingelheim u n-numru “150”.
English: Two pack-sizes of Ofev 100 mg capsules are available:
Maltese: Hemm żewġ daqsijiet ta' pakketti disponibbli ta' Ofev 100 mg kapsuli:
English: Diarrhoea may lead to dehydration: a loss of fluid and important salts (electrolytes, such as sodium or potassium) from your body.
Maltese: Id-dijarea tista' twassal għal deidratazzjoni: telf ta' fluwidu u mluħa importanti (elettroliti, bħal sodium jew potassium) mill-ġisem tiegħek.
English: Patients with mild hepatic impairment (Child Pugh A) should be treated with a reduced dose of Ofev (see sections 4.2 and 5.2).
Maltese: Pazjenti b'indeboliment ħafif tal-fwied (Child Pugh A) għandhom jiġu kkurati b'doża mnaqqsa ta' Ofev (ara sezzjonijiet 4.2 u 5.2).
English: All-cause mortality over 52 weeks in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set
Maltese: Tabella 6: Mortalità bil-kawżi kollha fuq 52 ġimgħa fil-provi INPULSIS-1, INPULSIS-2 u d-dejta raggruppata tagħhom - sett ikkurat
English: Patients should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, e.g. loperamide, and may require treatment interruption.
Maltese: Il-pazjenti għandhom jiġu kkurati malli jfeġġu s-sinjali b'idratazzjoni adegwata u bi prodotti mediċinali kontra d-dijarea, eż. loperamide, u tista' tkun teħtieġ interruzzjoni.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: Бьорингер Ингелхайм РЦВ ГмбХ и Ко.
Maltese: Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГклон България
English: In the INPULSIS-2 trial, the risk of first acute IPF exacerbation over 52 weeks was significantly reduced in patients receiving nintedanib compared to placebo, in the INPULSIS-1 trial there was no difference between the treatment groups.
Maltese: Fil-prova INPULSIS-2, ir-riskju tal-ewwel taħrix akut tal-IPF fuq 52 ġimgħa tnaqqas b'mod sinifikanti fil-pazjenti li ngħataw nintedanib meta mqabbel ma' plaċebo, fil-prova INPULSIS-1 ma kien hemm l-ebda differenza bejn il-gruppi tal-kura.
English: In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to nintedanib decreased to 50.3% based on AUC and to 60.3% based on Cmax upon co-administration with rifampicin compared to administration of nintedanib alone.
Maltese: Fi studju dwar linterazzjonijiet bejn mediċina u oħra bl-induttur potenti ta' P-gp rifampicin, l-esponiment għal nintedanib naqas għal 50.3% ibbażat fuq l-AUC u għal 60.3% ibbażat fuq is-Cmax mal-għoti flimkien ma' rifampicin meta mqabbel mal-għoti ta' nintedanib waħdu.
English: INFORMATION IN BRAILLE Ofev 100 mg
Maltese: Ofev 100 mg
English: If you do not tolerate the recommended dose of two Ofev 150 mg capsules per day (see possible side effects in section 4) your doctor may reduce the daily dose of Ofev.
Maltese: Jekk ma tittollerax id-doża rakkomandata ta' żewġ kapsuli ta' Ofev 150 mg kuljum (ara effetti sekondarji possibbli f'sezzjoni 4) it-tabib tiegħek jista' jnaqqas id-doża ta' kuljum ta' Ofev.
English: Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischemia.
Maltese: L-interruzzjoni tal-kura għandha tiġi kkunsidrata f'pazjenti li jiżviluppaw sinjali jew sintomi ta' iskemija mijokardijaka akuta.
English: Supportive evidence from the phase II trial (1199.30) Ofev 150 mg twice daily results Additional evidence of efficacy is provided by the randomised, double-blind, placebo-controlled, dose finding phase II trial including a nintedanib 150 mg twice daily dose group.
Maltese: II, randomizzata, double-blind, ikkontrollata bi plaċebo, għas-sejba tad-doża li kienet tinkludi grupp tad-doża nintedanib 150 mg darbtejn kuljum.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900
Maltese: KG Tel: +49 (0) 800 77 90 900
English: SGRQ total score measuring health related quality of life (HRQoL) was analysed at 52 weeks.
Maltese: Il-punteġġ totali SGRQ li jkejjel il-kwalità tal-ħajja relatata mas-saħħa (HRQoL) kien analizzat f'ġimgħat 52.
English: The estimated mean change from baseline in SGRQ total score at 52 weeks was 5.46 for placebo, indicating worsening of the health-related quality of life and -0.66 for nintedanib, indicating stable health-related quality of life.
Maltese: Il-bidla medja stmata mil-linja bażi fil-punteġġ totali SGRQ f'ġimgħat 52 kienet 5.46 għall-plaċebo, li turi deterjorament tal-kwalità tal-ħajja relatata mas-saħħa u -0.66 għal nintedanib, li turi kwalità talħajja relatata mas-saħħa stabbli.
English: Ofev 100 mg soft capsules are peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “100”.
Maltese: Ofev 100 mg kapsuli rotob huma kapsuli tal-ġelatina ratba ta' kulur lewn il-ħawħ, opaki, oblungi, stampati fuq naħa waħda bl-iswed bis-simbolu tal-kumpanija Boehringer Ingelheim u n-numru “100”.
English: Co-administration with pirfenidone
Maltese: Kura mogħtija ma' pirfenidone
English: The key secondary endpoints were change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score at 52 weeks and time to first acute IPF exacerbation.
Maltese: Il-punti aħħarin sekondarji prinċipali kienu l-bidla mil-linja bażi fil-punteġġ totali tal-Kwestjonarju Respiratorju Saint George (SGRQ) wara 52 ġimgħa u ż-żmien sal-ewwel taħrix akut tal-IPF.
English: United Kingdom Boehringer Ingelheim Ltd. Tel: +44 1344 424 600
Maltese: Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600
English: Method of administration
Maltese: KG organizačná zložka
English: Frequency of patients with acute IPF exacerbations over 52 weeks and time to first exacerbation analysis based on investigator-reported events in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set
Maltese: Tabella 5: Frekwenza ta' pazjenti b'taħrix akut tal-IPF fuq 52 ġimgħa u analiżi taż-żmien sal-ewwel taħrix ibbażata fuq avvenimenti rrapportati minn investigatur fil-provi INPULSIS-1, INPULSIS-2 u d-dejta raggruppata tagħhom - sett ikkurat
English: The potential impact of VEGFR inhibition by nintedanib and the antiangiogenic activity of nintedanib on IPF pathology are currently not fully elucidated.
Maltese: L-impatt potenzjali tal-inibizzjoni tal-VEGFR b'nintedanib u l-attività antianġjoġenika ta' nintedanib fuq il-patoloġija tal-IPF għadhom mhux iċċarati sew.
English: This could be symptoms of serious liver problems; - if you have severe pain in your stomach, fever, chills, sickness, vomiting, or abdominal rigidity or bloating, as these could be symptoms of a hole in the wall of your gut (‘gastrointestinal perforation').
Maltese: Dawn jistgħu jkunu sintomi ta' problemi serji tal-fwied - jekk ikollok uġigħ sever fl-istonku, deni, tertir, mard, rimettar jew riġidità jew nefħa fiż-żaqq, għax dawn jistgħu jkunu sintomi ta' toqba fil-ħajt tal-imsaren tiegħek (‘perforazzjoni gastrointestinali').
English: Boehringer Ingelheim Sp. z o.o.
Maltese: Boehringer Ingelheim Ellas A.E.
English: Table 1 summarizes the frequencies of adverse drug reactions (ADRs) that were reported in the nintedanib group (638 patients) pooled from the two placebo-controlled Phase III clinical trials of 52 weeks duration or from the post-marketing period.
Maltese: Tabella 1 tipprovdi sommarju tal-frekwenzi tar-reazzjonijiet avversi tal-mediċina (ADRs) li kienu rrappurtati fil-grupp ikkurat b'nintedanib (638 pazjent) miġburin flimkien miż-żewġ provi kliniċi talFażi
English: Data from Black individuals were very limited but in the same range as for Caucasians.
Maltese: Dejta minn individwi suwed kienet limitata ħafna, iżda fl-istess medda bħal dik għal Kawkasi.
English: Due to the mechanism of action of nintedanib patients might have an increased risk of gastrointestinal perforation.
Maltese: Minħabba l-mod kif jaħdem nintedanib il-pazjenti jista' jkollhom riskju miżjud ta' perforazzjoni gastrointestinali.
English: Only a weak inhibitory potential on OCT-1, BCRP, and P-gp was observed in vitro which is considered to be of low clinical relevance.
Maltese: Nintedanib ukoll ma kienx substrat ta' BCRP Ġie osservat potenzjal inibitorju dgħajjef biss fuq OCT-1, BCRP, u P-gp in vitro, li hu kkunsidrat li hu ta' rilevanza klinika baxxa.
English: Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways, with CYP 3A4 being the predominant enzyme involved.
Maltese: Parti żgħira biss tal-bijotrasformazzjoni ta' nintedanib kienet tikkonsisti minn passaġġi ta' CYP, b'CYP 3A4 li tkun l-enzima predominanti involuta.
English: Due to the mechanism of action of nintedanib patients might have an increased risk of thromboembolic events.
Maltese: Minħabba l-mekkaniżmu ta' azzjoni ta' nintedanib il-pazjenti jista' jkollhom riskju miżjud ta' avvenimenti tromboemboliċi.
English: Transport
Maltese: Trasport
English: Patients with low body weight (< 65 kg), Asian and female patients have a higher risk of elevations of liver enzymes.
Maltese: Pazjenti b'piż tal-ġisem baxx (< 65 kg), pazjenti Asjatiċi u nisa, għandhom riskju ogħla ta' żidiet flenzimi tal-fwied.
English: Annual rate of decline in FVC
Maltese: Rata annwali ta' tnaqqis fl-FVC
English: Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300
Maltese: Boehringer Ingelheim Sp. z o.o. Tel: +48 22 699 0 699
English: Two patients in the oncology programme had an overdose of maximum 600 mg twice daily up to eight days.
Maltese: Żewġ pazjenti fil-programm tal-onkoloġija kellhom doża eċċessiva ta' massimu ta' 600 mg darbtejn kuljum sa tmint ijiem.
English: Women who can become pregnant must use an effective combination of birth control methods, including barrier methods as a second form of contraception, while they are taking Ofev and for at least 3 months after stopping treatment.
Maltese: Nisa li jistgħu joħorġu tqal iridu jużaw kombinazzjoni effettiva ta' kontraċezzjoni, li jinkludu metodi barriera bħala t-tieni forma ta' kontraċezzjoni, waqt li jkunu qed jieħdu Ofev u għal mill-inqas 3 xhur wara li titwaqqaf il-kura.
English: Boehringer Ingelheim Zagreb d.o.o.
Maltese: Boehringer Ingelheim b.v.
English: In the INPULSIS trials no increased risk of venous thromboembolism was observed in nintedanib treated patients.
Maltese: Fil-provi INPULSIS ma kien osservat l-ebda riskju miżjud ta' tromboemboliżmu venuż fil-pazjenti kkurati b'nintedanib.
English: In patients with mild hepatic impairment (Child Pugh A), the recommended dose of Ofev is 100 mg twice daily approximately 12 hours apart.
Maltese: F'pazjenti b'indeboliment ħafif tal-fwied (Child Pugh A), id-doża rakkomandata ta' Ofev hija 100 mg darbtejn kuljum b'intervall ta' 12-il siegħa bejniethom.
English: Nausea led to discontinuation of nintedanib in 2.0% of patients.
Maltese: In-nawseja wasslet għal twaqqif ta' nintedanib fi 2.0% tal-pazjenti.
English: In INPULSIS-2, patients receiving placebo had a larger increase from baseline SGRQ total score as compared to patients receiving nintedanib 150 mg twice daily.
Maltese: F'INPULSIS-2, il-pazjenti li ngħataw plaċebo kellhom żieda ikbar mill-punteġġ totali SGRQ tal-linja bażi meta mqabbla mal-pazjenti li ngħataw nintedanib 150 mg darbtejn kuljum.
English: An inverse correlation between body weight and exposure to nintedanib was observed.
Maltese: Ġiet osservata korrelazzjoni inversa bejn il-piż tal-ġisem u l-esponiment għal nintedanib.
English: Uncommon side effects (may affect up to 1 in 100 people) - Pancreatitis - Inflammation of the large bowel - Serious liver problems - Low platelet count (thrombocytopenia) - High blood pressure (hypertension) - Jaundice, that is a yellow colour to the skin and whites of the eyes due to high levels of bilirubin - Itching - heart attack - Hair loss (alopecia)
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw aktar minn pazjent 1 minn kull 10) - Tħossok imdardar (nawseja) - Uġigħ fil-parti t'isfel tal-ġisem (iż-żaqq)
English: Renal and urinary disorders
Maltese: Disturbi fil-kliewi u fis-sistema urinarja
English: Boehringer Ingelheim b.v. Tel: +31 (0) 800 22 55 889
Maltese: Tel: +31 (0) 800 22 55 889
English: For further information about special populations, recommended measures and dosing adjustments in case of diarrhoea and hepatic enzyme increased, refer additionally to sections 4.4 and 4.2, respectively.
Maltese: Għal informazzjoni dwar popolazzjonijiet speċjali, miżuri rakkomandati u aġġustamenti fid-dożaġġ f'każ ta' dijarea u żidiet fl-enzimi tal-fwied, irreferi għal sezzjoni 4.4 u 4.2, rispettivament.
English: Hepatic enzyme increased
Maltese: Reazzjoni allerġika
English: These changes are known from other VEGFR-2 inhibitors and can be considered class effects.
Maltese: Dan it-tibdil hu magħruf minn inibituri ta' VEGFR-2 oħrajn u jista' jiġi kkunsidrat bħala effetti tal-klassi.
English: Diarrhoea (very common, may affect more than 1 in 10 people):
Maltese: Dijarea (komuni ħafna, tista' taffettwa aktar minn pazjent 1 minn kull 10):
English: In patients with mild hepatic impairment (Child Pugh A), treatment interruption or discontinuation for management of adverse reactions should be considered.
Maltese: F'pazjenti b'indeboliment ħafif tal-fwied (Child Pugh A), għandha tiġi kkunsidrata l-interruzzjoni jew it-twaqqif tal-kura għallimmaniġġjar ta' reazzjonijiet avversi.
English: Time to event analysis of the adjudicated exacerbation events using pooled data yielded a hazard ratio (HR) of 0.32 (95% CI 0.16, 0.65; p=0.0010).
Maltese: 32 (95% CI 0.16, 0.65; p=0.0010).
English: Hypertension
Maltese: Emorraġija
English: Skin and subcutaneous tissue disorders
Maltese: Analiżi tas-sopravivenza
English: EMA/123532/2013 EMEA/H/C/002500
Maltese: EMEA/H/C/002500
English: The full EPAR for Pheburane 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: Pheburane is available as granules (483 mg/g).
Maltese: Pheburane jiġi bħala granuli (483 mg/g).
English: Pheburane is a ‘hybrid medicine'.
Maltese: Pheburane huwa ‘mediċina ibrida'.
English: This summary was last updated in 08-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'08-2013.
English: Pheburane is a medicine that contains the active substance sodium phenylbutyrate.
Maltese: Pheburane huwa mediċina li fiha s-sustanza attiva sodium phenylbutyrate.
English: Pheburane sodium phenylbutyrate
Maltese: Sommarju tal-EPAR għall-pubbliku sodium phenylbutyrate
English: Why is Pheburane approved?
Maltese: Għal xiex ġie approvat Pheburane?
English: The reference medicine for Pheburane is Ammonaps.
Maltese: Il-mediċina ta' referenza għal Pheburane hija Ammonaps.
English: This is a summary of the European public assessment report (EPAR) for Pheburane.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pheburane.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pheburane on 31 July 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pheburane fit-31 ta' Lulju 2013.
English: What are the benefits and risks of Pheburane?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pheburane?
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Pheburane granules are available at a lower strength and contain different excipients (inactive ingredients) to mask the unpleasant taste of the active substance.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' li fiha l-istess sustanza attiva, iżda l-granuli ta' Pheburane jiġu b'doża aktar baxxa u fihom eċċipjenti differenti (sustanzi inattivi) biex jaħbu t-togħma ħażina tas-sustanza attiva.
English: Because Pheburane is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Pheburane huwa mediċina ibrida u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The active substance in Pheburane, sodium phenylbutyrate, is converted into a substance called phenylacetate in the body.
Maltese: Is-sustanza attiva f'Pheburane, issodium phenylbutyrate, tinbidel f'sustanza li tissejjaħ phenylacetate fil-ġisem.
English: Studies in patients have been limited to tests to determine that Pheburane is bioequivalent to the reference medicine, Ammonaps.
Maltese: L-istudji fil-pazjenti kienu limitati għal testijiet sabiex jiġi determinat li Pheburane huwa bijoekwivalenti għall-mediċina ta' referenza, Ammonaps.
English: The Committee recommended that Pheburane be approved for use in the EU.
Maltese: IlKumitat irrakkomanda li Pheburane ikun approvat għall-użu fl-UE.
English: How has Pheburane been studied?
Maltese: Kif ġie studjat Pheburane?
English: Pheburane is used in patients who lack one or more of the following enzymes: carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinate synthetase.
Maltese: Pheburane jintuża f'pazjenti li huma nieqsa minn enzima waħda jew iktar minn dawn li ġejjin: carbamylphosphate synthetase, ornithine transcarbamylase, jew argininosuccinate synthetase.
English: Phenylacetate combines with the amino acid glutamine, which contains nitrogen, to form a substance that can be removed from the body by the kidneys.
Maltese: Fil-ġisem, innitroġenu żejjed ikun f'forma ta' ammonia, li ssir tossika meta din takkumula, speċjalment għall-moħħ.
English: Other information about Pheburane
Maltese: Kif jintuża Pheburane?
English: • 'late-onset' disease in patients who show a partial lack of one or more of these enzymes after the age of one month and have had high blood ammonia levels that affected the brain's activity.
Maltese: • marda li 'toħroġ aktar tard' f'pazjenti b'nuqqasijiet parzjali f'enzima waħda jew aktar li jidhru wara l-ewwel xahar ta' ħajja u li għandhom livelli għolja ta' ammonia fid-demm li affettwaw l-attività talmoħħ.
English: It can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in treating patients with urea cycle disorders.
Maltese: Id-doża ta' kuljum ta' Pheburane għandha tkun maħduma b'mod individwali għal kull pazjent u tiddependi mid-dieta, it-tul u l-piż tal-pazjent.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Pheburane has been shown to have comparable quality and to be bioequivalent to Ammonaps.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li Pheburane wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Ammonaps.
English: Pack size
Maltese: Il-pakkett li jmiss malprodott
English: EU Number
Maltese: Numru tal-EU Isem (ivvintat)
English: CHMP opinion
Maltese: Opinjoni tas-CHMP
English: The PRAC adopted a recommendation on 17 March 2016 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Il-PRAC adotta rakkomandazzjoni, fis-17 ta' Marzu 2016 li dak iż-żmien kienet ikkunsidrata mis-CHMP, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
English: ICS-containing products authorised across the EU for the treatment of COPD includes the active substances beclomethasone, fluticasone propionate, fluticasone furoate, budesonide and flunisolide.
Maltese: Prodotti li fihom ICS awtorizzati fl-UE kollha għall-kura tal-COPD jinkludu s-sustanzi attivi beclomethasone, fluticasone propionate, fluticasone furoate, budesonide u flunisolide.
English: Exacerbations and comorbidities contribute to the overall severity in individual patients [Global Initiative for Obstructive Lung Disease (GOLD), 2015].
Maltese: Taħrix u komorbiditajiet jikkontribwixxu għas-severità ġenerali f'pazjenti individwali [Global Initiative for Obstructive Lung Disease (GOLD), 2015].
English: A signal of increased risk of pneumonia in COPD patients with ICS-containing treatments was first identified in the TORCH study (Calverley et al., 2007) a large clinical study of three years treatment duration comparing the fluticasone propionate/salmeterol combination with its component parts and placebo in COPD patients.
Maltese: Sinjal ta' riskju miżjud ta' pulmonite f'pazjenti b'COPD b'kuri li fihom ICS kien l-ewwel identifikat flistudju TORCH (Calverley et al., 2007), studju kliniku kbir ta' tliet snin ta' kura li qabbel ilkombinazzjoni ta' fluticasone propionate/salmeterol mal-partijiet komponenti tiegħu u plaċebo filpazjenti b'COPD.
English: Symptoms of COPD include dyspnoea, chronic cough and chronic sputum production.
Maltese: Sintomi ta' COPD jinkludu dispnea, sogħla kronika u produzzjoni kronika ta' sputum.
English: The therapeutic effect of inhaled corticosteroids is considered to be the result of suppression of airway inflammation, but the airway effects of ICS in COPD are complex and the mechanism of action is not completely understood (Finney et al., 2014, Jen et al., 2012).
Maltese: L-effett terapewtiku ta' kortikosterojdi li jittieħdu man-nifs huwa meqjus bħala li huwa r-riżultat ta' trażżin ta' infjammazzjoni tal-passaġġ tal-arja, iżda l-effetti tal-passaġġi tal-arja tal-ICS f'COPD huma kumplessi u l-mekkaniżmu ta' azzjoni mhuwiex mifhum għal kollox (Finney et al., 2014, Jen et al., 2012).
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for inhaled corticosteroids (ICS)-containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease (COPD);
Maltese: • Il-PRAC qies il-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE li rriżultat minn data ta' farmakoviġilanza għal prodotti mediċinali li fihom il-kortikosterojdi (ICS) li jittieħdu man-nifs indikati fil-kura ta' mard għall-kura ta' mard pulmonari ostruttiv kroniku (COPD);
English: • The PRAC also concluded that there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among ICS-containing products;
Maltese: • Il-PRAC ikkonkluda wkoll li ma hemm ebda evidenza klinika konklussiva għal differenzi bejn klassi u oħra fid-daqs tar-riskju fost prodotti li fihom ICS;
English: Chronic obstructive pulmonary disease (COPD) is characterised by persistent, usually progressive, airflow limitation associated with an enhanced inflammatory response in the airways and the lungs.
Maltese: Il-mard pulmonari ostruttiv kroniku (COPD) huwa kkaratterizzat minn limitazzjoni tal-fluss tal-arja persistenti, normalment progressiv assoċjat ma' rispons infjammatorju mtejjeb fil-passaġġi tal-arja u tal-pulmuni.
English: However ICSs are an important therapeutic option for certain patient groups as established in some treatment guidelines (GOLD report, 2015).
Maltese: Madankollu, l-ICSs huma opzjoni terapewtika importanti għal ċerti gruppi ta' pazjenti kif stabbilit f'xi linji gwida ta' kura (GOLD report, 2015).
English: No clinical trials directly examined the risk of pneumonia with ICSs head to head, and only indirect comparison in meta-analyses/systematic reviews or from observational studies is available, mainly between budesonide and fluticasone.
Maltese: Ebda prova klinika ma eżaminat direttament ir-riskju ta' pulmonite b'ICSs ras għal ras, u tqabbil indirett biss f'metaanaliżi/rieżamijiet sistematiċi jew minn studji ta' osservazzjoni huwa disponibbli, prinċipalment bejn budesonide u fluticasone.