FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical study, subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively.
Maltese: Fi studju kliniku, individwi ta' eta' ta' bejn it-18-60 sena ingħataw doża booster ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat jew minn A/Vietnam/1194/2004 jew minn Indonesia/5/2005 sitt xhur wara li kienu ħadu doża jew tnejn inizjali ta' vaċċin stimulat li fih 3.75μg HA derivat minn A/Vietnam/1194/2004 f'ġurnata 0 jew fi ġranet 0 u 21 rispettivament.
English: However, in the event of an officially declared influenza pandemic, persons previously vaccinated with one or two doses of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg that contained HA antigen derived from a different clade of the same influenza subtype as the pandemic influenza strain may receive a single dose of Pandemrix instead of two doses that are required in previously unvaccinated individuals.
Maltese: Madankollu, fil-kas ta' pandemiku ta' l-influwenza iddikjarat uffiċjalment, nies li jkunu tlaqqmu qabel b'doża waħda jew tnejn tal-vaċċin ta' l-influwenza Prepandemika (H5N1) (virjon maqsum, inattivat, stimulat) GlaxoSmithKline Biologicals 3.75μg li fih antiġen HA derivat minn clade differenti ta' l-istess subtip ta' influwenza bħar-razza ta' influwenza pandemika jistgħu jirċievu doża waħda ta' Pandemrix minflok iż-żewġ dożi necessarji f'individwi mhux imlaqqma qabel.
English: The emulsion is a whitish homogeneous liquid.
Maltese: L-emulsjoni hija likwidu omoġenju bajdani.
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml).
Maltese: Il-volum wara li jiħallat kunjett wieħed ta' suspensjoni (2.5 ml) ma' kunjett wieħed ta' emulsjoni (2.5ml) jikkorispondi għal 10 dożi ta' vaċċin (5ml).
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (these are listed at the end of this leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
Maltese: • jekk xi darba kellek reazzjoni allerġika f'daqqa waħda li tkun ta' periklu għal-ħajja għal kwalunkwe ingredjent ta' Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg (dawn huma mniżżla fl-aħħar ta' dan il fuljett), jew għal xi wieħed mis-sustanzi li jista' jkun fih f'ammonti żgħar ħafna: proteini talbajd jew tat-tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate (antibiotiku) jew sodium deoxycholate.
English: 0, 6 months schedule
Maltese: 4.6 Tqala u Treddigħ
English: PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic:
Maltese: Sottomissjoni ta' PSUR meta Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg jintuża waqt influwenza pandemika:
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkustraße 40, D-01069 Dresden Germany
Maltese: Zirkustraße 40, D-01069 Dresden Il-Ġermanja
English: Split influenza virus, inactivated, containing antigen equivalent to A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Maltese: Virus maqsum, mhux attivat ta' l-influwenza li jkun fih antiġen ekwivalenti għal razza tixbaħ lil A/VietNam/1194/2004
English: After mixing, one dose (0.5 ml) contains 3.75 micrograms of haemagglutinin from the following influenza virus strain:
Maltese: Wara li jitħallat, doża waħda (0.5 ml ) ikun fiha 3.75 mikrogrammi ta' emagglutinina mir-razza tal-virus ta' l-influwenza li ġej:
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection Prepandemic influenza vaccine (H5N1)
Maltese: Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg suspensjoni għal emulsjoni għall-injezzjoni Vaċċin għal influwenza prepandemika (H5N1)
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Maltese: Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat)
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml)
Maltese: Il-volum wara li jitħallat kunjett 1 ta' suspensjoni (2.5ml) ma' kunjett 1 ta' emulsjoni (2.5ml) jikkorrispondi għal 10 dożi ta' vaċċin (5ml)
English: At day 42, the anti-HA antibody responses were as follows:
Maltese: F'ġurnata 42, ir-responsi ta' l-antikorpi anti-HA kienu kif ġej:
English: A 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in >90% of subjects after two doses regardless of the schedule.
Maltese: Żieda ta' 4 darbiet aktar fl-antikorpi li jinnewtralizzaw is-serum kontra A/Indonesia/5/2005 intlaħqu f'>90 mill-individwi wara żewġ dożi kienet x'kienet l-iskeda.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection.
Maltese: Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is a vaccine for use in adults from 18 years old.
Maltese: Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg huwa vaċċin għall-użu fl-adulti ta' età minn 18 sa 60 sena.
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Maltese: Storja ta' reazzjoni anafilattika (i.e. li tista' twassal għall-mewt) għal xi wieħed mill-kostitwenti jew traċċi ta' residwi (proteina tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate u sodium deoxycholate) ta' dan il-vaċċin.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two containers:
Maltese: Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg jikkonsisti f'żewġ kontenituri:
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection IM
Maltese: Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg suspensjoni għal emulsjoni għall-injezzjoni IM
English: Vasculitis with transient renal involvement.
Maltese: U DETENTUR TA' LAWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: EXP: MM/YYYY
Maltese: Mhux komuni: telqa
English: Based on very limited data, adults aged >80 years may require a double dose of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1).
Maltese: Fuq bażi ta' data limitata ħafna, adulti ta' eta' >80 sena jista' jkollhom bżonn doża doppja ta' vaċċin ta' l-influwenza Prepandemic (H5N1) (virjon maqsum, inattivat, stimulat) GlaxoSmithKline Biologicals 3.75μg f'data fissa u għal darb'oħra wara intervall ta' almenu tlett ġimgħat biex jaslu għal respons immuni (ara sezzjoni 5.1)
English: 3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT.
Maltese: 3fattur tal-booster: il-proporzjon ta' titru ġeometriku intermedju (GMT) wara l-vaċċinazzjoni u l-GMT qabel il-vaċċinazzjoni.
English: The anti-HA responses were as follows:
Maltese: Ir-respons anti-HA kien kif ġej:
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Maltese: F'sitwazzjoni pandemika, il-frekwenza tas-sottomissjoni ta' rapporti perjodikament aġġornati dwar sigurta` speċifikata fl-Artikolu 24 tar-Regolament (KE) Nru 726/2004 ma tkunx biżżejjed għallmonitoraġġ tas-sigurta` ta' vaċċin pandemiku li dwaru huma mistennija livelli għolja ta' esponiment fi żmien qasir.
English: Very limited data in seronegative subjects >80 years of age (N=5) showed that no subject achieved seroprotection following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1).
Maltese: Data limitata ħafna f'individwi seronegattivi ta' eta' ta' >80 sena (N=5) uriet li ma ntlaħqet l-ebda rata ta' seroprotezzjoni wara żewġ amministrazzjonijiet ta' doża waħda ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivati minn A/Vietnam/1194/2004
English: It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
Maltese: Lintenzjoni hija li jingħata qabel jew waqt il-pandemija ta' l-influwenza li jmiss biex jilqa' kontra linfluwenza kkawżata mit-tip H5N1 tal-virus.
English: Immunisation should be carried out by intramuscular injection.
Maltese: Disturbi gastro-intestinali
English: Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Maltese: Emulsjoni għal emulsjoni għall-injezzjoni għal Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg
English: Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg IM
Maltese: Emulsjoni għal emulsjoni għall-injezzjoni għal Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg IM
English: Take special care with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
Maltese: Tieħux Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg:
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Maltese: Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni Vaċċin ta' l-influwanza prepandemika (H5N1) (virjon maqsum, inattivat, stimulat)
English: This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1).
Maltese: Din l-indikazzjoni hija bbażata fuq dejta ta' immunoġeniċità minn individwi b'saħħithom mill-età ta' 18-il sena ‘l fuq wara amministrazzjoni ta' żewġ dożi ta' vaċċin ippreparati minn A/VietNam/1194/2004
English: In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Maltese: Fi studju kliniku ieħor, 39 individwu ta' eta' bejn it-18-60 sena ingħataw doża booster ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivati minn A/Indonesia/5/2005 erbatax-il xahar wara li jkunu ingħataw żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75μg derivati minn A/Vietnam/1194/2004 li ngħataw f'ġurnata 0 u ġurnata 21.
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained.
Maltese: Barra mill-perjodu pandemiku, tinżamm il-frekwenza u l-format tas-soltu tal-PSUR.
English: How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Maltese: X'fih Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg looks like and contents of the pack
Maltese: Id-dehra ta' Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg u l-kontenuti tal-pakkett
English: If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can still be given but your response to the vaccine may be poor.
Maltese: Jekk tieħu xi mediċini li jnaqqsu l-immunita` għall-infezzjonijiet jew jekk tkun tieħu xi tip ta' kura oħra (bħal radjoterapija) li taffettwa s-sistema immuni, Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg xorta jista' jingħata iżda r-respos tiegħek għall-vaċċin jista' jkun batut.
English: These side effects may occur with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Maltese: Inti se tirċievi żewġ dożi ta' Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat) GlaxoSmithKline Biologicals 3.75 µg.
English: (See Table 1).
Maltese: (Ara Tabella 1).
English: Wait 5 to 15 minutes;
Maltese: Stenna 5 sa 15-il minuta;
English: - Worsening of symptoms.
Maltese: - Aggravar tas-sintomi.
English: Absolute % predicted Relative % predicted
Maltese: % Relattiv previst
English: Date of first authorisation: 13 April 2012 Date of latest renewal: 11 January 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta' April 2012 Data tal-aħħar tiġdid: 11 ta' Jannar 2017
English: Aluminium/polyamide/PVC/aluminium blisters.
Maltese: Aluminju/poliamide/PVC/folji tal-aluminju.
English: Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland.
Maltese: Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Irlanda.
English: Adult Population
Maltese: Popolazzjoni Adulta
English: ATC code: R05CB16
Maltese: R05CB16
English: Step 1 - 1 capsule (40 mg) Step 2 - 2 capsules (80 mg) Step 3 - 3 capsules (120 mg) Step 4 - 4 capsules (160 mg)
Maltese: Pass 1 - 1 kapsula (40 mg) Pass 2 - 2 kapsuli (80 mg) Pass 3 - 3 kapsuli (120 mg) Pass 4 - 4 kapsuli (160 mg)
English: Arvato distribution GmbH Gottlieb-Daimler Straβe 1 33428 Harsewinkel North Rhine-Westphalia Germany
Maltese: Arvato distribution GmbH Gottlieb-Daimler Straβe 1 33428 Harsewinkel North Rhine-Westphalia Ġermanja
English: Bacteria sputum identified
Maltese: Batterji identifikati fl-isputum,
English: D18AY29
Maltese: Dublin 18, D18AY29 Irlanda
English: Note: There were some differences in analysis methods across the 3 studies.
Maltese: Nota: Kien hemm xi differenzi fil-metodi ta' analiżi fost it-3 studji.
English: Adults 18 years of age and over
Maltese: Adulti ta' 18-il sena u iktar
English: Pharmacodynamic effects
Maltese: Effetti farmakodinamiċi .
English: Each capsule contains 40 milligrams mannitol.
Maltese: Kull kapsula fiha 40 milligramma mannitol.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≥1/100,000 to <1/10,000); not known (cannot be estimated from the available data).
Maltese: 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); rari ħafna (≥1/100,000 sa <1/10,000); mhux magħruf (ma jistax jiġi stmat mid-data disponibbli).
English: Arvato distribution GmbH, Gottlieb-Daimler Straβe 1, 33428 Harsewinkel, North Rhine-Westphalia Germany
Maltese: Arvato distribution GmbH, Gottlieb-Daimler Straβe 1, 33428 Harsewinkel, North Rhine-Westphalia, Ġermanja.
English: Pharmaxis Europe Limited 108 Q House, Furze Road,
Maltese: Pharmaxis Europe Limited 108 Q House
English: Mawdsleys Clinical Services, Unit 22, Quest Park, Wheatley Hall Road, Doncaster, DN2 4LT, United Kingdom.
Maltese: Mawdsleys Clinical Services, Unit 22, Quest Park, Wheatley Hall Road, Doncaster, DN2 4LT, IrRenju Unit.
English: The active substance is mannitol.
Maltese: Is-sustanza attiva hija mannitol.
English: A massive/serious haemoptysis is considered to be:
Maltese: Emoptisi massiva/serja hija kkunsidrata bħala:
English: Study DPM-CF-303 was all adult patients.
Maltese: Studju DPMCF-303 kien kollu pazjenti adulti.
English: 10 hard capsules and 1 inhaler
Maltese: 10 kapsulin iebsin u 1 inalatur
English: If the capsule has not emptied you may need to repeat steps 6 to 8.
Maltese: Jekk il-kapsula ma titbattalx jista' jkollok bżonn tirrepeti l-passi 6 sa 8.
English: Initiation dose (6 to 17 years of age)
Maltese: Tfal (minn 6 sa 17-il sena)
English: Uncommon Pruritus, Pruritic rash
Maltese: Mhux komuni Prurite, Raxx pruritiku
English: Pharmacotherapeutic group: Cough and cold preparations, Mucolytic.
Maltese: Kategorija farmakoterapewtika:Preparazzjonijiet għas-sogħla u għal riħ, Mucolytic.
English: 2D barcode carrying the unique identifier included.
Maltese: Barcode 2D li għandu l-identifikatur uniku inkluż
English: When administered intravenously, mannitol is eliminated largely unchanged by glomerular filtration and 87% of the dose is excreted in the urine within 24 hours.
Maltese: Meta mogħti ġol-vina, mannitol ġeneralment jiġi eliminat mhux mibdul permezz ta' filtrazzjoni glomerulari u 87% tad-doża tiġi eliminata fl-awrina fi żmien 24 siegħa.
English: In study 303 the relative change (95% CI) for rhDNase users and non-users was 1.30 (-0.91, 3.51) and 4.45 (0.52, 8.38), respectively.
Maltese: Fl-istudju 303 it-tibdil relattiv (95% CI) għal utenti ta' rhDNase u non-utenti kien ta' 1.30 (-0.91, 3.51) u 4.45 (0.52, 8.38), rispettivament.
English: Each hard capsule contains 40 mg mannitol.
Maltese: Kull kapsula iebsa fiha 40 mg mannitol.
English: Slovenská republika 4 Life Pharma SK, s.r.o.
Maltese: Slovenská republika 4 Life Pharma
English: CARTON - INITIATION DOSE PACK
Maltese: KARTUNA - PAKKETT TAD-DOŻA TAL-BIDU
English: Bronchodilator
Maltese: Bronkodilatur
English: In study 302 the relative change (95% CI) for rhDNase users and non-users was 3.21 (-0.61, 7.03) and 4.73 (-1.93, 11.40), respectively.
Maltese: Fl-istudju 302 it-tibdil relattiv (95% CI) għall-utenti ta' rhDNase u tan-non-utenti kien ta' 3.21 (-0.61, 7.03) u 4.73 (-1.93, 11.40), rispettivament.
English: Inhaler device
Maltese: Apparat tal-inalatur
English: However, Bronchitol has been used in clinical studies in conjunction with standard cystic fibrosis therapies such as mucolytics, antibiotics (including tobramycin and colistimethate sodium), bronchodilators, pancreatic enzymes, vitamins, inhaled and systemic corticosteroids, and analgesics.
Maltese: Madankollu, Bronchitol intuża fi studji kliniċi flimkien ma' terapiji standard għall-fibrożi ċistika bħal mucolytics, antibijotiċi (inkluż tobramycin u colistimethate sodium), bronkodilaturi, enzimi pankreatiċi, vitamini, kortikosterojdi sistematiċi u li jittieħdu man-nifs, u analġeżiċi.
English: Inhalation powder, hard capsule.
Maltese: Trab għall-inalazzjoni, kapsula iebsa.
English: The safety profile of Bronchitol has been evaluated in clinical studies involving more than 1200 patients.
Maltese: Il-profil tas-sigurtà ta' Bronchitol ġie evalwat fi studji klinċi li involvew aktar minn 1200 pazjent.
English: A bronchodilator must be administered 5-15 minutes before each dose of Bronchitol.
Maltese: Bronkodilatur għandu jingħata 5-15-il minuta qabel kull doża ta'Bronchitol
English: Uncommon (may affect up to 1 in 100 people) - Burning or painful sensation on the tongue - CF related diabetes - Chest and abdominal pain - Change in voice - Cold sweat - Congestion - Dehydration - Decreased appetite - Diarrhoea - Ear pain - Feeling tired - Feeling dizzy - Feeling sick (nausea) - Feeling unwell - Flu and fever - Wind - Heartburn - Hernia pain - Hyperventilation - Itching, rash, acne - Joint stiffness and pain - Morbid thoughts - Mouth ulcers - Respiratory tract infection - Runny nose - Sputum infection - Throat irritation - Trouble sleeping - Yeast infection of the mouth (thrush) - Unintentional loss of urine
Maltese: Mhux komuni (jaffettwaw aktar minn persuna 1 minn kull 100) - Sensazzjoni ta' ħruq jew ta' uġigħ fl-ilsien - Dijabete relatata mas-CF - Uġigħ fis-sider u uġigħ addominali - Tibdil fil-vuċi - Għaraq kiesaħ - Konġestjoni - Deidratazzjoni - Tnaqqis fl-aptit - Dijarea - Uġigħ fil-widnejn - Tħossok għajjien/a - Tħossok imdardar (dardir) - Tħossok stordut/a - Tħossok ma tiflaħx - Influwenza u deni - Gass - Ħruq ta' stonku - Uġigħ tal-ftuq - Iperventilazzjoni - Ħakk, raxx, akne - Ebusija u uġigħ fil-ġogi - Ħsibijiet morbużi - Ulċeri fil-ħalq - Infezzjoni fil-passaġġ respiratorju - Flissjoni - Infezzjoni tal-isputum - Irritazzjoni fil-griżmejn - Diffikultà biex torqod - Infezzjoni tal-ħmira fil-ħalq (ħrar) - Taħrablek l-awrina
English: Mean delivered dose per capsule is 32.2 mg.
Maltese: Id-doża medja f'kull kapsula hija ta' 32.2 mg.
English: An additional 2.8% (n=34) of patients from the three studies had incomplete MTTs and were not randomised.
Maltese: Żieda addizzjonali ta' 2.84% (n=34) ta' pazjenti mit-tliet studji kellhom MTTs inkompleti u ma kienux randomizzati.
English: The Tmax after inhaled administration was 1.5 ± 0.5 hours.
Maltese: It-Tmax wara l-għoti man-nifs kien ta' 1.5 ± 0.5 sigħat.
English: In a study of 9 cystic fibrosis patients (6 adults, 3 adolescents), using 400 mg inhaled mannitol as a single dose (Day 1) then twice a day for 7 days (Days 2 - 7), pharmacokinetic parameters were similar for adults and adolescents, except for a longer average apparent terminal half life for adolescents (Day 1 = 7.29 hours, Day 7 = 6.52 hours) compared with adults (Day 1 = 6.10 hours, Day 7 = 5.42 hours).
Maltese: Fi studju fuq 9 pazjenti bil-fibrożi ċistika (6 adulti, 3 adoloxxenti), bl-użu ta' 400 mg ta' mannitol man-nifs bħala doża waħda (Jum 1) u wara darbtejn kuljum għal 7t ijiem (Jiem 2 - 7), il-parametri farmakokinetiċi kienu simili għall-adulti u għall-adoloxxenti, ħlief għal medja itwal tal-half life terminali apparenti għall-adoloxxenti (Jum 1 = 7.29 siegħa, Jum 7 = 6.52 siegħa) meta mqabbla maladulti (Jum 1 = 6.10 sigħat, Jum 7 = 5.42 siegħa).
English: Uncommon Initial insomnia, Morbid thoughts
Maltese: Mhux komuni Insonnja inizjali, Ħsibijiet morbużi
English: Cough, Haemoptysis,
Maltese: Sogħla, Kundizzjoni aggravata, Emoptisi,
English: Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
Maltese: Bronchitol huwa indikat għall-kura tal-fibrożi ċistika (CF) f'adulti li għandhom 'l fuq minn 18-il sena bħala terapija miżjuda mal-aqwa kura standard.