FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC considered the preliminary new safety data from a recent fatal case of fulminant liver failure and from cases of serious liver injury that occurred since the marketing authorisation, in the context of the data generated during the clinical development of daclizumab.
Maltese: Il-PRAC ikkunsidra d-data dwar is-sigurtà ġdida preliminarja minn każ fatali riċenti ta' insuffiċjenza talfwied fulminanti u minn każijiet ta' ħsara serja fil-fwied li saru sa mill-awtorizzazzjoni għat-tqegħid fissuq, fil-kuntest tad-data ġġenerata matul l-iżvilupp kliniku ta' daclizumab.
English: The efficacy of daclizumab was demonstrated in two pivotal studies in subjects with relapsing remitting multiple sclerosis that led to the indication in relapsing multiple sclerosis.
Maltese: L-effikaċja ta' daclizumab intweriet f'żewġ studji pivotali f'individwi bi sklerożi multipla remittenti rikaduta, li wasslet għall-indikazzjoni fi sklerożi multipla rikaduta.
English: Libertek is contraindicated in patients with moderate or severe liver impairment (Child Pugh B or C).
Maltese: Libertek hu kontraindikat f'pazjenti b'indeboliment moderat jew sever tal-fwied (Child Pugh B jew Ċ).
English: ¾ The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g. multiple sclerosis, lupus erythematous, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Libertek should not be initiated or should be stopped in these patients.
Maltese: In-nuqqas ta' esperjenza f'pazjenti b'infezzjoni bl-HIV jew epatite attiva, b'mard immunoloġiku sever (eż. sklerosi multipla, lupus eritematuż, lewkoenċefalopatija multifokali) jew li jkunu kkurati b'terapija immunosoppressiva (minbarra kortikosterojdi sistemiċi għal żmien qasir) u li Libertek m'għandux jinbeda jew għandu jitwaqqaf f'dawn il-pazjenti.
English: ¾ The potential cardiac risk: Libertek has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Maltese: Libertek ma ġiex studjat f'pazjenti b'insuffiċjenza konġestiva talqalb (NYHA grad 3 u 4); għaldaqstant, mhuwiex rakkomandat f'din il-popolazzjoni.
English: ¾ The potential risk of infections: Libertek should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Maltese: Ir-riskju potenzjali ta' infezzjonijiet: Libertek m'għandux jinbeda, jew il-kura għandha titwaqqaf, f'pazjenti b'mard infettiv sever u akut.
English: The fact that Libertek is not indicated for the treatment of COPD patients other than those covered by the approved indication, nor for use in patients with asthma or alpha 1 anti trypsine deficiency.
Maltese: Il-fatt li Libertek mhuwiex indikat għall-kura ta' pazjenti b'COPD, ħlief dawk koperti mill-indikazzjoni approvata, u lanqas għall-użu f'pazjenti b'ażżma jew defiċjenza ta' alpha 1 anti trypsine.
English: ¾ The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Libertek and the potential risk of suicide.
Maltese: Ir-riskju ta' mard psikjatriku bħal nuqqas ta' rqad, ansjetà, u dipressjoni f'pazjenti li jkunu qed jirċievu Libertek u r-riskju potenzjali ta' suwiċidju.
English: • The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Libertek are provided with an Educational pack.
Maltese: • Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jiżgura li, fit-tnedija talprodott, il-Professjonisti fil-Qasam tal-Kura tas-Saħħa li huma mistennija li jagħtu riċetta għal Libertek, jingħataw il-Pakkett edukattiv.
English: Patient Card
Maltese: Kard tal-Pazjent
English: The patient card should contain the following key elements:
Maltese: Ir-riskju kardijaku potenzjali:
English: 14 January 2016 EMA/168579/2015
Maltese: EMA/168579/2015
English: Ambroxol and bromhexine medicines have been authorised in: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
Maltese: Il-mediċini ambroxol u bromhexine ġew awtorizzati f': l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, irRepubblika Ċeka, id-Danimarka, l-Estonja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Iżlanda, lIrlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, in-Netherlands, in-Norveġja, il-Polonja, ilPortugall, ir-Rumanija, is-Slovakkja, is-Slovenja, Spanja u l-Isvezja.
English: Ambroxol and bromhexine expectorants: safety information updated
Maltese: Ambroxol u bromhexine expectorants: informazzjoni aġġornata dwar is-sigurtà
English: The review of ambroxol and bromhexine was initiated on 4 April 2014 at the request of Belgium, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' ambroxol u bromhexine nbeda fl-4 ta' April 2014 fuq talba tal-Belġju, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: • Anaphylactic reactions and severe cutaneous adverse reactions (SCARs), including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis, have been reported in patients receiving ambroxol.
Maltese: • Reazzjonijiet anafilattiċi u reazzjonijiet avversi severi fil-ġilda (SCARs), li jinkludu eritema multiformi, sindrome ta' Stevens-Johnson/nekroliżi epidermali tossika u exanthematous pustulosis ġeneralizzata akuta, ġew irrappurtati f'pazjenti li qed jirċievu ambroxol.
English: On 18 November 2015, the CMDh1 endorsed by majority vote recommendations to update the product information for ambroxol- and bromhexine-containing medicines with information about the small risk of severe allergic reactions and severe cutaneous adverse reactions (SCARs).
Maltese: Fit-18 ta' Novembru 2015, is-CMDh1 approva b'votta' maġġoranza rakkomandazzjonijiet biex jaġġorna l-informazzjoni dwar il-prodott għall-mediċini li fihom ambroxol u bromhexine b'informazzjoni dwar irriskju żgħir ta' reazzjonijiet allerġiċi severi u reazzjonijiet avversi severi tal-ġilda (SCARs).
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
Maltese: 1 Is-CMDh huwa korp regolatorju tal-mediċini li jirrappreżenta lill-Istati Membri tal-Unjoni Ewropea (UE).
English: Ambroxol- and bromhexine-containing medicines are marketed as single products or as fixed combination products with various other active ingredients.
Maltese: Il-mediċini li fihom ambroxol u bromhexine huma kummerċjalizzati bħala prodotti individwali jew bħala prodotti b'kombinazzjoni fissa b'diversi sustanzi attivi oħra.
English: In making the recommendations, the PRAC evaluated available data on ambroxol and bromhexine, including reports of severe allergic reactions or SCARs.
Maltese: Huwa u jagħmel ir-rakkomandazzjonijiet, il-PRAC evalwa data disponibbli dwar ambroxol u bromhexine, inkluż rapporti ta' reazzjonijiet allerġiċi severi jew SCARs.
English: • As ambroxol is a metabolite of bromhexine, the risk of anaphylactic and severe cutaneous reactions is considered to apply also to bromhexine.
Maltese: • Peress li ambroxol huwa metabolit ta' bromhexine, ir-riskju ta' reazzjonijiet anafilattiċi u severi filġilda huwa meqjus li japplika wkoll għal bromhexine.
English: The recommendations were originally made by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed the previously known risk of allergic reactions and also identified a small risk of SCARs, a group of skin conditions which include erythema multiforme and Stevens-Johnson syndrome.
Maltese: Ir-rakkomandazzjonijiet kienu oriġinarjament magħmula mill-Kumitat tal-Evalwazzjoni tar-Riskju filqasam tal-Farmakoviġilanza (PRAC) tal-EMA, li kkonferma r-riskju li qabel kien magħruf ta' reazzjonijiet allerġiċi u identifika wkoll riskju żgħir ta' SCARs, grupp ta' kondizzjonijiet tal-ġilda li jinkludu eritema multiformi u s-sindromu Stevens-Johnson.
English: • There is a small risk of allergy and skin reactions with ambroxol and bromhexine used as expectorants to clear mucus in the airways.
Maltese: • Hemm riskju żgħir ta' allerġija u reazzjonijiet tal-ġilda ma' ambroxol u bromhexine użati bħala expectorants sabiex ineħħu l-mukus fil-passaġġi tal-arja.
English: Frequencies of these side effects are unknown.
Maltese: Il-frekwenzi ta' dawn l-effetti sekondarji mhumiex magħrufa.
English: This position was then sent to the European Commission which issued an EU-wide legally binding decision on 14/01/2016.
Maltese: Din il-pożizzjoni mbagħad intbagħtet lill-Kummissjoni Ewropea li ħarġet deċiżjoni vinkolanti legalment fl-14/01/2016.
English: • The risk of anaphylactic reactions and SCARs with ambroxol or bromhexine is low.
Maltese: • Ir-riskju ta' reazzjonijiet anafilattiċi u SCARs b'ambroxol jew bromhexine huwa baxx.
English: Risk of allergy and skin reactions included in the product information
Maltese: Riskju ta' allerġija u reazzjonijiet tal-ġilda inklużi fl-informazzjoni dwar dan ilprodott
English: Reports of severe allergic reactions and SCARs in patients taking the medicines are rare, and the frequencies of these side effects are unknown.
Maltese: Rapporti ta' reazzjonijiet allerġiċi severi u SCARs f'pazjenti li jkunu qed jieħdu l-mediċini huma rari, u l-frekwenzi ta' dawn l-effetti sekondarji mhumiex magħrufa.
English: Injectable formulations are also used to prevent and treat lung complications following surgery.
Maltese: Il-formulazzjonijiet injettabbli huma użati wkoll sabiex jipprevjenu u jikkuraw komplikazzjonijiet tal-pulmun wara l-kirurġija.
English: For ambroxol, lozenge formulations are also available to relieve sore throat.
Maltese: Għal ambroxol, il-formulazzjonijiet tal-mustardini huma wkoll disponibbli sabiex itaffu uġigħ filgriżmejn.
English: As ambroxol- and bromhexine-containing medicines are all authorised nationally, the PRAC recommendation was forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), for a position.
Maltese: huma kollha awtorizzati fuq livell nazzjonali, ir-rakkomandazzjoni tal-PRAC intbagħtet lill-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u l-Proċeduri Deċentralizzati - Bniedem (CMDh), għal pożizzjoni.
English: Hungary AstraZeneca Kft. Bocskai út 134-146.
Maltese: L-Ungerija AstraZeneca Kft. Bocskai út 134-146.
English: A -4020 Linz
Maltese: A -4020
English: DK-2605 Brøndby
Maltese: DK-2605 Brøndby Denmark
English: Rua Dr. António Loureiro Borges, 3 - ArquiparqueMiraflores
Maltese: António Loureiro Borges, 3 - ArquiparqueMiraflores
English: Norway AstraZeneca AS Innspurten 15
Maltese: In-Norveġja AstraZeneca AS Innspurten 15
English: Cyprus Medochemie Ltd 1-10 Constantinoupoleos Street
Maltese: Medochemie Ltd 1-10 Constantinoupoleos Street
English: Galenica SA 4, Eleftherias Street Kifisia 14564
Maltese: Il-Greċja Galenica SA 4, Eleftherias Street Kifisia 14564
English: B-1200 Woluwe-Saint
Maltese: B-1200 Woluwe-SaintLambert
English: Ireland GlaxoSmithKline (Ireland) Limited
Maltese: GlaxoSmithKline (Ireland) Limited
English: Belgium SCS Boehringer Ingelheim SA Avenue Ariane 16
Maltese: SCS Boehringer Ingelheim SA Avenue Ariane 16
English: Ireland AstraZeneca UK Limited 600 Capability Green Luton, LU1 3LU
Maltese: L-Irlanda AstraZeneca UK Limited 600 Capability Green Luton, LU1 3LU
English: 55216 Ingelheim Germany fenoterol
Maltese: 55216 Ingelheim
English: France AstraZeneca 1, place Renault 92844 Rueil Malmaison Cedex
Maltese: AstraZeneca 1, place Renault 92844
English: Laboratorio Reig Jofre SA. Gran Capita 10
Maltese: Laboratorio Reig Jofre SA.
English: Stonemasons Way
Maltese: Stonemasons
English: Austria AstraZeneca Österreich GmbH
Maltese: L-Awstrija AstraZeneca Österreich GmbH
English: Glaxo Wellcome UK Limited
Maltese: WELLCOME UK Limited
English: Luxembourg Eumedica S.A. Av. Winston Churchill 67 B-1180 Bruxelles Belgium ritodrine
Maltese: Winston Churchill 67 B-1180 Bruxelles Belgium ritodrine
English: Cvetkova ulica 29 1000 Ljubljana Slovenija
Maltese: 1000 Ljubljana Slovenija
English: BEROTEC 0,5MG/10 ML
Maltese: BEROTEC 0,5MG/10
English: Bricanyl Tablets 5mg
Maltese: Bricanyl Tablets 5mg 5mg
English: Actavis UK Limited Whiddon Valley Barnstaple
Maltese: Ir-Renju Unit Actavis UK Limited Whiddon Valley
English: Denmark GlaxoSmithKline Pharma A/S
Maltese: GlaxoSmithKline Pharma A/S
English: Austria hexoprenaline GYNIPRAL 10 MCG/2 ML
Maltese: Austria hexoprenaline GYNIPRAL 10 μg/2 ml
English: Warszawskie Zakłady Farmaceutyczne Polfa S.A. ul.
Maltese: Warszawskie Zakłady Farmaceutyczne Polfa S.A.
English: Lithuania Warszawskie Zakłady Farmaceutyczne Polfa S.A. ul.
Maltese: Il-Litwanja Warszawskie Zakłady Farmaceutyczne Polfa S.A. ul.
English: Austria hexoprenaline GYNIPRAL 25 MCG
Maltese: Linz Austria hexoprenaline GYNIPRAL 25 MCG
English: Romania GLAXO WELLCOME UK Limited
Maltese: Ir-Renju Unit Glaxo Wellcome UK Limited
English: Czech Republic Takeda Austria GmbH St.-Peter-Straße 25
Maltese: Ir-Rumanija NYCOMED Austria GmbH St.-Peter-Straße 25
English: Boehringer Ingelheim Pharma GmbH & Co. KG Binger Str. 173
Maltese: Il-Ġermanja Boehringer Ingelheim Pharma GmbH & Co.
English: Luxembourg GlaxoSmithKline Pharmaceuticals S.A./N.V.
Maltese: GlaxoSmithKline Pharmaceuticals S.A./N.V.
English: Teva UK Limited Bampton Road Hampden Park Eastbourne
Maltese: Ir-Renju Unit Teva UK Limited Bampton Road
English: Rathfarnham
Maltese: Way Rathfarnham Dublin 16
English: Asmaven 2 / Salbutamol Tablets BP 2mg
Maltese: Asmaven 2 / Salbutamol Pillolas
English: Concentrate for solution for injection
Maltese: Solution for injection
English: NYCOMED Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria hexoprenaline GYNIPRAL
Maltese: NYCOMED Austria GmbH St.-Peter-Straße 25 A -4020
English: Asmaven 4 / Salbutamol Tablets BP 4mg
Maltese: Asmaven 4 / Salbutamol Pillolas
English: Subcutaneous, intramuscular, intravenous
Maltese: Soluzzjoni għal injezzjoni/infużjoni
English: Lambert
Maltese: Errobi
English: Takeda Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria hexoprenaline Gynipral 25 μgKonzentrat zur
Maltese: Takeda Austria GmbH St.-Peter-Straße 25 A -4020
English: Belgium GlaxoSmithKline Pharmaceuticals S.A./N.V.
Maltese: Il-Belġju GlaxoSmithKline Pharmaceuticals S.A./N.V. Site Apollo, 2-4-6
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn għandu jingħata, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: GSK d.o.o.
Maltese: Eumedica S.A.
English: Takeda Austria GmbH St.-Peter-Straße 25 A -4020 Linz Austria hexoprenaline Gynipral 10 μg / 2 ml - Ampullen
Maltese: Linz Austria hexoprenaline Gynipral 10 μg / 2 ml - Ampullen
English: Modified-release tablet
Maltese: Salbutamol Pillolas
English: Insulin human
Maltese: Insulina umana
English: Comparator N= 253, 238, 252, 248,
Maltese: Komparatur N= 253, 238, 252, 248,
English: Respiratory,
Maltese: Respiratorji).
English: Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13, 9NJ United Kingdom
Maltese: Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13, 9NJ Ir-Renju Unit
English: Comparator N=145, 143, 125, 129, 120.
Maltese: Komparatur N=145, 143, 125, 129, 120.
English: Pharmacotherapeutic group: Medicinal products used in diabetes, ATC code: A10AF01
Maltese: Prodotti mediċinali wżati fid-dijabete, Kodiċi ATC: A10AF01
English: Body weight (kg) X 0.15 mg/kg = Total Daily Dose (mg).
Maltese: Piż tal-ġisem (kg) X 0.15 mg/kg = Doża Totali ta' Kuljum (mg).
English: Mean GIR (% of Maximum)
Maltese: GIR medja (% talMassimu
English: Decline in pulmonary function
Maltese: Tnaqqis fil-funzjoni pulmonari
English: GmbH & Co. KG, Heinrich Mack Strasse 35, 89257, Illertissen, Germany.
Maltese: KG, Heinrich Mack Strasse 35, 89257,
English: Also contains: Mannitol, glycine, sodium citrate (as dihydrate), sodium hydroxide
Maltese: Fih ukoll: Mannitol, glycine, sodium citrate (bħala dihydrate), sodium hydroxide
English: INFORMATION IN BRAILLE EXUBERA 1 mg
Maltese: INFORMAZZJONI BIL-BRAILLE EXUBERA 1 mg
English: Produced by recombinant DNA technology in Escherichia coli.
Maltese: Magħmula permezz ta' teknoloġija rekombinanti tad-DNA f'Escherichia coli.
English: Exubera (6mg) Fast-acting Human Insulin (18 U)
Maltese: Exubera (6mg) Insulina Umana li Tahdem Malajr (18 U)
English: INFORMATION IN BRAILLE EXUBERA 3 mg
Maltese: INFORMAZZJONI BIL-BRAILLE EXUBERA 3 mg
English: Pfizer Limited Ramsgate Road, Sandwich,
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq huwa Pfizer Limited, Ramsgate Road, Sandwich,
English: FEV1 reversibility
Maltese: Riversibbilità ta' FEV1
English: Inhaled Insulin Subcutaneous Insulin
Maltese: Inhaled Insulin
English: There are 6 blisters on each card and 5 cards per tray.
Maltese: Hemm 6 bżieżaq f'kull kartuna u 5 kartuniet f'kull trej.
English: Respiratory Diseases (Underlying Lung Disease)
Maltese: Mard Respiratorju (Mard tal-Pulmun Diġà Eżistenti)
English: Store below 30˚C.
Maltese: Aħżen f'temperatura taħt 30˚C.
English: Experience with inhaled insulin in patients 75 years of age is limited.
Maltese: Esperjenza b'insulina inalata f'pazjenti b'età ≥ 75 sena hija limitata.
English: In EXUBERA treated subjects 0.4% discontinued treatment due to dyspnoea.
Maltese: F'pazjenti ttrattati b'EXUBERA, 0.4% waqqfu t-trattament minħabba l-qtugħ ta' nifs.
English: 5.2 Pharmacokinetic properties
Maltese: 5.1 Tagħrif farmakodinamiku
English: The percentage of patients who achieved a goal of HbA1c < 7.0% was comparable between the treatment groups.
Maltese: Il-perċentwal ta' pazjenti li laħqu l-mira ta' HbA1c < 7.0% kien komparabbli bejn il-gruppi ta' trattament.
English: • A pack containing 30, 60, 90, 180 and 270 x 1 of 1 mg PVC/Aluminium perforated unit dose
Maltese: • Pakkett fih 30, 60, 90, 180 u 270 x 1 ta' 1 mg bżieżaq ipperforati tal-PVC/Aluminju ta' doża
English: EXUBERA (inhaled human insulin) is a fast-acting human insulin for use in type 1 or type 2 diabetes.
Maltese: EXUBERA (insulina umana inalata) hija insulina umana li taħdem malajr sabiex tintuża f'dijabete tip 1 jew tip 2.
English: 30 x 1 perforated unit dose blisters 60 x 1 perforated unit dose blisters 90 x 1 perforated unit dose blisters 180 x 1 perforated unit dose blisters 270 x 1 perforated unit dose blisters
Maltese: 30 x 1 bużżieqa ta' doża waħda perforata 60 x 1 bużżieqa ta' doża waħda perforata 90 x 1 bużżieqa ta' doża waħda perforata 180 x 1 bużżieqa ta' doża waħda perforata 270 x 1 bużżieqa ta' doża waħda perforata
English: • A pack containing 30, 60, 90, 180 and 270 x 1 of 3 mg PVC/Aluminium perforated unit dose
Maltese: • Pakkett fih 30, 60, 90, 180 u 270 x 1 ta' 3 mg bżieżaq ipperforati tal-PVC/Aluminju ta' doża
English: congestive heart failure, pregnancy, children and adolescent
Maltese: falliment konġestiv tal-qalb, tqala, tfal u adolexxenti.
English: When EXUBERA was administered to healthy volunteers following 2-hours of passive exposure to cigarette smoke in a controlled experimental setting, insulin AUC and Cmax were reduced by approximately 17 and 30%, respectively (see section 4.5).
Maltese: Meta EXUBERA ngħatat lil voluntiera b'saħħithom wara sagħtejn ta' espożizzjoni passiva għadduħħan tas-sigaretti f'sitwazzjoni esperimentali, l-AUC u s-Cmax ta' l-insulina tnaqqsu b'madwar 17% u 30%, rispettivament (ara sezzjonijiet 4.5).
English: EXUBERA - Centrul de Rela)ii cu Clien)ii Tel.: 0800 390 000
Maltese: EXUBERA - Centrul de Relaţii cu Clienţii Tel.: 0800 390 000
English: Fast-acting Human Insulin (12 IU)
Maltese: Insulina Umana li taħdem malajr (12 IU)
English: Insulin antibodies may develop during treatment with all insulins including EXUBERA.
Maltese: Antikorpi ta' l-insulina jistgħu jiżviluppaw waqt trattament bl-insulini kollha inkluż EXUBERA.
English: In a study where the dosage form of three 1 mg blisters was compared with one 3 mg blister, Cmax and AUC of inhaling three 1 mg blisters were approximately 30% and 40% greater, respectively, than that of inhaling from one 3 mg blister, indicating that three 1 mg blisters are not interchangeable with one 3 mg blister (see sections 2, 4.2 and 4.4).
Maltese: Fi studju fejn il-forma tad-dożaġġ ta' tliet bżieżaq ta' 1 mg ġiet imqabbla ma' dik ta' bużżieqa waħda ta' 3 mg, isCmax u l-AUC ta' l-inalazzjoni ta' bużżieqa waħda ta' 3 mg kienu madwar 30% u 40% akbar, rispettivament, milli dawk ta' inalazzjoni ta' bużżieqa waħda ta' 3 mg, li tindika li 3 bżieżaq ta' 1 mg mhumiex skambjabbli ma' bużżieqa ta' 3 mg (ara sezzjoni 2, 4.2 u 4.4).
English: Store below 30°C.
Maltese: Aħżen f'temperatura taħt 30oC.
English: FEV1 decline
Maltese: Tnaqqis fl-FEV1
English: Peak insulin concentration is reached generally by 45 minutes for inhaled human insulin.
Maltese: Il-konċentrazzjoni massima ta' l-insulina ġeneralment tintlaħaq f'45 minuta għal insulina umana inalata.
English: Cough - A cough may occur within seconds to minutes after inhaling EXUBERA.
Maltese: Sogħla - Tista' tiżviluppa sogħla wara ftit sekondi sa minuti wara l-inalazzjoni ta' EXUBERA.
English: In Phase 2/3 trials, 9 out of 2498 subjects treated with EXUBERA were discontinued from trials due to a decline in pulmonary function whose end of study FEV1 showed a decline of ≥ 15% from baseline.
Maltese: Fi provi ta' Fażi 2/3, 9 minn 2,498 pazjent ittrattat b'EXUBERA twaqqfu mill-provi minħabba tnaqqis fil-funzjoni pulmonari li l-FEV1 tagħha fl-aħħar ta' l-istudju wera tnaqqis ta' 15% mil-linja bażi ta' referenza.
English: The manufacturer is Heinrich Mack Nachf.
Maltese: Il-manifattur huwa Heinrich Mack Nachf. GmbH & Co.
English: Small treatment group differences (favouring comparator) in change from baseline of 0.034L in type 1 and 0.039L in type 2 occurred after 2 years of therapy.
Maltese: Differenzi żgħar fil-grupp ta' trattament (li jiffavorixxu l-mediċina ta' tqabbil) fil-bidla mil-linja ta' referenza bażi ta' 0.034L f'tip 1 u 0.039L f'tip 2 seħħew wara sentejn ta' terapija.
English: Do not take EXUBERA
Maltese: Tieħux EXUBERA
English: Bioavailability of inhaled human insulin relative to subcutaneously administered fast-acting human insulin was comparable to that of adult subjects with type 1 diabetes (see section 4.2).
Maltese: Il-bijodisponibilità ta' insulina umana inalata meta mqabbla ma' insulina umana li taħdem malajr mogħtija taħt il-ġilda kienet komparabbli ma' dik f'pazjenti adulti b'dijabete ta' tip 1 (ara sezzjoni 4.2).
English: A decline from baseline in FEV1 of > 15% occurred in 1.3% of EXUBERA-treated type 1 subjects and in 5.0% of EXUBERA-treated type 2 subjects.
Maltese: Kien hemm tnaqqis mil-linja bażi ta' referenza ta' FEV1 ta' > 15% f'1.3% ta' pazjenti ta' tip 1 ittrattati b'EXUBERA u f'5.0% ta' pazjenti ta' tip 2 ittrattati b'EXUBERA.
English: Note: In the overall clinical program, including uncontrolled extension studies, there were two reports of pleural effusion in which a treatment-related effect could not be excluded.
Maltese: Nota: Fil-program kliniku totali, inkluż studji t'estensjoni mingħajr kontrolli, kien hemm żewġ rapporti ta' tnixxija plewrali fejn effett relatat mat-trattament ma setax jiġi eskluż.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE AUTHORISATION HOLDER(S) RESPONSIBLE FOR
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I) U> DETENTUR
English: Number of 3 mg Blisters per Dose
Maltese: Numru ta' Bżieżaq ta' 3 mg kull doża
English: Beta-blocking agents may mask the symptoms of hypoglycaemia.
Maltese: Mediċini beta-blockers jistgħu jgħattu s-sintomi ta' l-ipogliċemija.
English: If the hypoglycaemia comes back again take another 10 to 20 gram sugar.
Maltese: Jekk l-ipogliċemija terġa' sseħħ, ħu 10 sa 20 gramma zokkor oħra.
English: N=Number of Subjects at Baseline, week 12, week 24, week 36 , week 48, week 60 , week 72 , INH N= 236, 231, 233, 233, 235, 235, 226, 217, 208, 236.
Maltese: N=Number of Subjects at Baseline, week 52, week 104, week +6, week +12. INH and INH washout N=158, 155, 143, 139, 123. Comparator N=145, 143, 125, 129, 120.