FrancophonIA/ELRC3.0 huggingface dataset:
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce somatropin.
Maltese: Dan huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': l-ormon huwa magħmul minn batterji li fihom ikun ġie introdott ġene (DNA) li permezz tiegħu jkunu jistgħu jipproduċu s-somatropina.
English: NutropinAq replaces the natural hormone.
Maltese: NutropinAq jissostitwixxi l-ormon naturali.
English: • children who fail to grow because of a lack of growth hormone;
Maltese: • tfal li ma jikbrux minħabba nuqqas tal-ormon tal-iżvilupp;
English: They should use a different injection site each day.
Maltese: L-injezzjoni għanda tingħata f'postijiet differenti kuljum.
English: What is NutropinAq?
Maltese: X'inhu NutropinAq?
English: In children, these side effects are seen in between 1 and 10 patients in 100.
Maltese: Fit-tfal, dawn l-effetti sekondarji dehru f'bejn 1 u 10 minn kull 100 pazjent.
English: NutropinAq is used to treat the following groups of children:
Maltese: NutropinAq jintuża fit-trattament ta' dawn il-gruppi ta' tfal:
English: • girls from 2 years old who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
Maltese: • Bniet minn sentejn 'il fuq li huma qosra minħabba s-sindromu ta' Turner (disturb ġenetiku rari li jaffettwa l-bniet), ikkonfermat permezz ta' analiżi tal-kromożomi (testijiet bid-DNA);
English: The active substance in NutropinAq, somatropin, is identical to human growth hormone.
Maltese: Is-sustanza attiva f'NutropinAq, issomatropina, hija identika għall-ormon tal-iżvilupp fil-bniedem.
English: NutropinAq is also used to treat adults with a deficiency (low levels) of growth hormone.
Maltese: NutropinAq jintuża wkoll fil-kura tal-adulti b'defiċjenza (livelli baxxi) tal-ormon tal-iżvilupp.
English: Somatropin may interfere with the body's use of insulin.
Maltese: Somatropina tista' tinterferixxi mal-użu tal-insulina mill-ġisem.
English: Other information about NutropinAq
Maltese: Aktar tagħrif dwar NutropinAq
English: Why has NutropinAq been approved?
Maltese: Għaliex ġie approvat NutropinAq?
English: The European Commission granted a marketing authorisation valid throughout the European Union for NutropinAq on on 16 February 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal NutropinAq valida fl-Unjoni Ewropea kollha fis-16 ta' Frar 2001.
English: The most serious side effects reported were the development of neoplasms (tumours) and intracranial hypertension (increased pressure inside the skull).
Maltese: L-effetti sekondarji rrappurtati bħala l-aktar serji kienu l-iżvilupp ta' neoplażmi (tumuri) u ipertensjoni intrakranjali (żieda ta' pressjoni ġewwa l-kranju).
English: What is the risk associated with NutropinAq?
Maltese: X'riskji huma assoċjati ma' NutropinAq ?
English: The CHMP concluded that NutropinAq's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP ikkonkluda li l-benefiċċji ta' NutropinAq huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: In adults, NutropinAq increased lean body mass and reduced total body fat.
Maltese: Il-kejl ewlieni fl-istudji tal-adulti kienu l-massa korporja u t-tnaqqis tax-xaħam totali fil-ġisem.
English: How has NutropinAq been studied?
Maltese: Kif ġie studjat NutropinAq?
English: How does NutropinAq work?
Maltese: Għal xiex jintuża NutropinAq?
English: For the full list of all side effects reported with NutropinAq, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'NutropinAq, ara l-fuljett ta' tagħrif.
English: EMA/668089/2014 EMEA/H/C/002314
Maltese: EMEA/H/C/002314
English: Duavive conjugated oestrogens / bazedoxifene
Maltese: Duavive estroġeni konjugati / bazedoxifene
English: The full EPAR and risk management plan summary for Duavive 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: Other information about Duavive
Maltese: Informazzjoni oħra dwar Duavive
English: Why is Duavive approved?
Maltese: Għaliex ġie approvat Duavive?
English: This is a summary of the European public assessment report (EPAR) for Duavive.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Duavive.
English: Similar results were seen with a higher strength of conjugated oestrogen (0.625 mg) plus bazedoxifene 20 mg when compared with placebo.
Maltese: Riżultati simili dehru b'qawwa ikbar ta' estroġenu konjugat (0.625 mg) b'bazedoxifene 20 mg meta mqabbel malplaċebo.
English: Duavive contains two active substances: conjugated oestrogens and bazedoxifene.
Maltese: Duavive fih żewġ sustanzi attivi: estroġeni konjugati u bazedoxifene.
English: Some women must not use Duavive including those who have had problems with venous thromboembolism (blood clots in the veins) such as deep-vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal-vein thrombosis (a blood clot at the back of the eye), or are at an increased risk of such problems.
Maltese: Ċertu nisa ma għandhomx jużaw Duavive inklużi dawk li kellhom problemi bi tromboemboliżmu vaskulari (emboli tad-demm fil-vini) bħal trombożi fil-vini profondi (DVT), emboliżmu pulmonari (embolu tad-demm fil-pulmun) u trombożi fil-vini retinali (embolu tad-demm fuq in-naħa ta' wara talgħajn), jew li qegħdin f'riskju miżjud ta' problemi simili.
English: In the study investigating the effects on hot flushes, treatment with Duavive (conjugated oestrogen 0.45 mg and bazedoxifene 20 mg) over 12 weeks reduced the average daily number of moderate and severe hot flushes by 7.6 compared with 4.9 for placebo.
Maltese: Fl-istudju li investiga l-effetti fuq fwawar, il-kura b'Duavive (estroġenu konjugat 0.45 mg u bazedoxifene 20 mg) fuq medda ta' 12-il ġimgħa naqqset l-għadd medju ta' fwawar moderati u severi ta' kuljum b'7.6 meta mqabbel ma' 4.9 għall-plaċebo.
English: Duavive was compared with placebo (a dummy treatment) in two main studies in 996 women who have been through the menopause, investigating the effects on either hot flushes or vulvovaginal atrophy (dryness, irritation and soreness around the genital area).
Maltese: Duavive tqabbel ma' plaċebo (kura finta) f'żewġ studji ewlenin f'996 nisa li għaddew mill-menopawża, fejn ġew investigati l-effetti fuq fwawar jew atrofija vulvovaġinali (nixfa, irritazzjoni u uġigħ mad-dawra taż-żona ġenitali).
English: What are the risks associated with Duavive?
Maltese: X'inhuma r-riskji assoċjati ma' Duavive?
English: It is available as modified release tablets (containing 0.45 mg conjugated oestrogens and 20 mg bazedoxifene) which release bazedoxifene immediately and conjugated oestrogens over a longer period of time.
Maltese: Huwa disponibbli bħala pilloli ta' rilaxx modifikat (li fihom 0.45 mg ta' estroġeni konjugati u 20 mg bazedoxifene) li jirrilaxxaw bazedoxifene mill-ewwel u lestroġeni konjugati fuq perjodu ta' żmien itwal.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duavive on 16 December 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Duavive fis-16 ta' Diċembru 2014.
English: An additional study also looked at the effects of Duavive on osteoporosis.
Maltese: Studju addizzjonali ħares ukoll lejn l-effetti ta' Duavive fuq osteoporożi.
English: The CHMP also noted that long-term use of Duavive is associated with a risk of stroke and venous thromboembolism which is similar to the risk with conjugated oestrogens and bazedoxifene when used alone.
Maltese: Is-CHMP innota wkoll li l-użu fit-tul ta' Duavive huwa assoċjat ma' riskju ta' puplesija u tromboemboliżmu vaskulari li huwa simili għar-riskju b'estorġeni konjugati u bazedoxifene meta jintuża waħdu.
English: Treatment with Duavive also led to a greater average fall in the daily severity score of hot flushes than placebo treatment: 0.9 versus 0.3.
Maltese: Kura b'Duavive wasslet ukoll għal tnaqqis medju ikbar fil-punteġġ tas-severità ta' kuljum ta' fwawar mill-kura bi plaċebo: 0.9 kontra 0.3.
English: However, oestrogens used alone can cause hyperplasia (growth) of the endometrium (lining of the womb) which could lead to endometrial cancer.
Maltese: Madankollu, estroġeni użati waħidhom jistgħu jikkawżaw iperplażija (tkabbir) tal-endometriju (l-inforra tal-ġuf) u dan jista' jwassal għal kanċer endometrijali.
English: One of the active substances in Duavive, conjugated oestrogens, works as hormone replacement therapy.
Maltese: Waħda mis-sustanzi attivi f'Duavive, l-estroġeni konjugati, taħdem bħala terapija ta' sostituzzjoni talormon.
English: For the full list of all side effects and restrictions with Duavive, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha u restrizzjonijiet b'Duavive, ara l-fuljett ta' tagħrif.
English: Regarding safety, the long-term risk of endometrial hyperplasia has not been fully investigated and the CHMP recommended further studies to be carried out.
Maltese: Fir-rigward tas-sigurtà, ir-riskju fit-tul ta' iperplażija endometrijali ma ġiex investigat bir-reqqa u sCHMP irrakkomanda li jitwettqu iktar studji.
English: Because the observed treatment effects were smaller than what is seen with alternative treatments (progestogen-containing treatments) the CHMP therefore concluded that Duavive should be reserved for women who cannot take these alternative medicines.
Maltese: Minħabba li l-effetti tal-kura osservati kienu iżgħar minn dawk li ntwerew b'kuri alternattivi (kuri li fihom proġestoġen) is-CHMP ikkonkluda li Duavive għandu jinżamm għal nisa li ma jistgħux jieħdu dawn il-mediċini alternattivi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duavive, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Id-doża rakkomandata ta' Duavive hija pillola waħda darba kuljum.
English: Conjugated oestrogens have been available for many years as hormone replacement therapy and bazedoxifene has been authorised in 2009 for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Maltese: L-estroġeni konjugati ilhom disponibbli bħala terapija għal sostituzzjoni tal-ormoni għal ħafna snin u bazedoxifene ġie awtorizzat fl2009 għall-kura ta' osteoporożi (marda li ddgħajjef l-għadam) f'nisa li għaddew mill-menopawża.
English: The study looking at the effects of Duavive on vulvovaginal atrophy found an improvement in some of the signs of vaginal atrophy but not in the most bothersome symptoms when compared with placebo.
Maltese: L-istudju li ħares lejn l-effetti ta' Duavive fuq atrofija vulvovaġinali sab titjib f'xi sinjali ta' atrofija vaġinali iżda mhux fl-iktar sintomi fastidjużi meta mqabbel mal-plaċebo.
English: Further information on NovoEight can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/novoeight.
Maltese: ema.europa.eu/en/medicines/human/EPAR/novoeight.
English: NovoEight (turoctocog alfa)
Maltese: NovoEight (turoktokog alfa)
English: The medicine contains the active substance turoctocog alfa.
Maltese: Il-mediċina fiha s-sustanza attiva turoktokog alfa.
English: NovoEight received a marketing authorisation valid throughout the European Union on 13 November
Maltese: NovoEight irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea fit-13 ta' Novembru 2013.
English: In the first study involving 150 patients aged 12 years and above, adolescents who used NovoEight to prevent bleeding had an average of 5.55 bleeding episodes per year and adults had an average of 6.68 bleeding episodes per year.
Maltese: Fl-ewwel studju li involva 150 pazjent li kellhom 12-il sena u aktar, adolexxenti li użaw NovoEight biex jipprevjenu l-fsada kellhom medja ta' 5.55 episodji ta' fsada kull sena u l-adulti kellhom medja ta' 6.68 episodji ta' fsada kull sena.
English: NovoEight was effective at preventing and treating bleeding episodes in two main studies involving a total of 213 patients with haemophilia A. Neither study compared NovoEight with any other medicines.
Maltese: NovoEight kien effettiv fil-prevenzjoni u l-kura ta' episodji ta' fsada f'żewġ studji ewlenin li involvew total ta' 213-il pazjent b'emofilja A.
English: Other information about NovoEight
Maltese: Informazzjoni oħra dwar NovoEight
English: NovoEight was rated as ‘excellent' or ‘good' at treating 116 of the 126 bleeding episodes.
Maltese: NovoEight ġie kklassifikat bħala “eċċellenti” jew “tajjeb” billi kkura 116 mill-126 episodju ta' fsada.
English: These inhibitors are antibodies that the immune system (the body's natural defences) produces against factor VIII.
Maltese: Dawn linibituri huma l-antikorpi li s-sistema immunitarja (id-difiżi naturali tal-ġisem) tipproduċi kontra l-fattur VIII.
English: In the second study involving 63 children less than 12 years of age, children treated with NovoEight had an average of 5.33 bleeding episodes per year.
Maltese: Fit-tieni studju li involva 63 tifel u tifla ta' inqas minn 12-il sena, it-tfal ikkurati b'NovoEight kellhom medja ta' 5.33 episodji ta' fsada kull sena.
English: What are the risks associated with NovoEight?
Maltese: X'inhuma r-riskji assoċjati ma' NovoEight?
English: NovoEight is available for injection into a vein.
Maltese: NovoEight jiġi bħala injezzjoni ġol-vina.
English: In addition, 89.4% of the bleeding episodes resolved after 1 to 2 doses of NovoEight.
Maltese: Barra minn hekk, 89.4 % tal-episodji ta' fsada ġew riżolti wara doża waħda sa żewġ dożi ta' NovoEight.
English: When used for the treatment of spontaneous bleeding, NovoEight was rated as ‘excellent' or ‘good' at treating 403 of 499 of the bleeding episodes.
Maltese: Meta ntuża għall-kura ta' fsada spontanja, NovoEight ġie kklassifikat bħala “eċċellenti” jew “tajjeb” billi kkura 403 minn 499 episodju ta' fsada.
English: The Agency concluded that NovoEight is effective for treating and preventing bleeding episodes, with effects similar to other factor VIII products.
Maltese: L-Aġenzija kkonkludiet li NovoEight huwa effettiv fil-kura u filprevenzjoni ta' episodji ta' fsada, b'effetti simili għal prodotti oħra tal-fattur VIII.
English: In addition, 95.2% of the bleeding episodes resolved after 1 to 2 doses of NovoEight.
Maltese: Barra minn hekk, 95.2 % tal-episodji ta' fsada ġew riżolti wara doża waħda sa żewġ dożi ta' NovoEight.
English: The safety profile of NovoEight was also considered similar to other factor VIII products.
Maltese: Il-profil tas-sigurtà ta' NovoEight tqies ukoll li huwa simili għal prodotti oħra tal-fattur VIII.
English: Hypersensitivity (allergic) reactions can occur rarely with NovoEight and may in some cases progress to severe allergic reactions.
Maltese: Reazzjonijiet ta' sensittività eċċessiva (allerġiċi) jistgħu jseħħu rarament b'NovoEight u f'xi każijiet jistgħu jipprogressaw għal reazzjonijiet allerġiċi severi.
English: Patients with haemophilia A lack factor VIII, which prevents blood from clotting and can cause problems such as bleeding in the joints, muscles or internal organs.
Maltese: Pazjenti b'emofilja A għandhom nuqqas tal-fattur VIII, li jipprevjeni lid-demm milli jagħqad u jista' jikkawża problemi bħal fsada fil-ġogi, fil-muskoli jew fl-organi interni.
English: The active substance in NovoEight, turoctocog alfa, works in the same way as natural factor VIII and helps the blood to clot.
Maltese: Is-sustanza attiva f'NovoEight, it-turoktokog alfa, taħdem fil-ġisem bl-istess mod bħall-fattur naturali VIII u tgħin sabiex id-demm jagħqad.
English: What measures are being taken to ensure the safe and effective use of NovoEight?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' NovoEight?
English: What benefits of NovoEight have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' NovoEight li ħarġu mill-istudji?
English: NovoEight is a medicine used to treat and prevent bleeding in patients with haemophilia A an inherited bleeding disorder caused by lack of factor VIII.
Maltese: NovoEight huwa mediċina li tintuża għall-kura u l-prevenzjoni ta' fsada f'pazjenti b'emofilja A, disturb ta' fsada li jintiret ikkawżat minn nuqqas ta' fattur VIII.
English: The European Medicines Agency decided that NovoEight's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' NovoEight huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: NovoEight is used to correct the factor VIII deficiency by replacing the missing factor VIII, thereby giving temporary control of the bleeding disorder.
Maltese: NovoEight jintuża biex jikkoreġi d-defiċjenza tal-fattur VIII billi jissostitwixxi l-fattur VIII nieqes, u b'hekk jagħti kontroll temporanju tad-disturb ta' fsada.
English: NovoEight (turoctocog alfa) EMA/655123/2019
Maltese: Ħarsa ġenerali lejn NovoEight u għalfejn huwa awtorizzat fl-UE
English: 3.1 mg / 24 h Transdermal patch Transdermal use sachet (coated paper/alu/LLDPE)
Maltese: Użu minn fuq il-ġilda qartas (karta miksija/alu/LLDPE)
English: 1 patch
Maltese: 1 garża
English: (Invented) name
Maltese: Numru ta'l-EU Isem inventat Qawwa
English: Solvent: 3 years.
Maltese: Solvent: 3 snin.
English: EU/1/09/543/001 EU/1/09/543/002
Maltese: EU/1/09/543/002
English: Figure 3a
Maltese: Figura 3a
English: Microbiology
Maltese: Mikrobijoloġija
English: Figure 3b
Maltese: Figura 3b
English: ESBLs from Class A, B and D beta-lactamases may have activity against aztreonam.
Maltese: ESBLs minn beta-lactamases ta' Klassi A, B u D, jista' jkollhom attività kontra aztreonam.
English: One plastic ampoule of solvent (0.17% w/v sodium chloride).
Maltese: Ampulla waħda tal-plastik bis-solvent (0.17% w/v sodium chloride).
English: Aztreonam exhibits activity in vitro against gram-negative aerobic pathogens, including P. aeruginosa.
Maltese: Aztreonam juri attività in vitro kontra patoġeni aerobiċi gram-negattivi li jinkludu P. aeruginosa.
English: rash1
Maltese: raxx1
English: bronchodilator mucolytics and lastly, Cayston.
Maltese: bronkodilatur mukolitiċi u fl-aħħar nett, Cayston.
English: Powder vial: 4 years.
Maltese: Kunjett bit-trab: 4 snin.
English: CP-AI-005 enrolled 246 adult (predominantly) and paediatric patients.
Maltese: CP-AI-005 irreġistra 246 persuna adulta (fil-biċċa l-kbira tagħhom) u pazjenti pedjatriċi.
English: Bronchospasm
Maltese: Bronkospażmu
English: Solvent for Cayston Sodium Chloride 0.17%
Maltese: Sodium Chloride 0.17%
English: Refer to section 4.4.
Maltese: Irreferi għal sezzjoni 4.4.
English: Solvent: 1 ml low density polyethylene ampoule.
Maltese: Ampulla ta' 1 ml ta' polyethylene b'densità baxxa.
English: An Altera Nebuliser Handset containing an Altera Aerosol Head connected to an eFlow Control Unit of the type 178 (eFlow rapid) or type 678 (eBase Controller).
Maltese: Altera Nebuliser Handset li fih Altera Aerosol Head ikkonnettjata ma' eFlow Control Unit tattip 178 (eFlow rapid) jew tip 678 (eBase Controller).
English: Class A betalactamases reported to hydrolyse aztreonam include the VEB type (primarily Southeast Asia), PER type (Turkey), and GES and IBC types (France, Greece, and S. Africa).
Maltese: Betalactamases ta' Klassi A irrappurtati li jidrolizzaw aztreonam jinkludu t-tip VEB (primarjament fixXlokk tal-Asja), it-tip PER (Turkija), u t-tipi GES u IBC (Franza, Greċja, u Afrika t'Isfel).
English: There are rare reports of Class D beta-lactamases from clinical isolates of P. aeruginosa, OXA-11 (Turkey) and OXA-45 (United States) that hydrolyse aztreonam.
Maltese: Kien hemm rapporti rari ta' beta-lactamases ta' Klassi D mill-iżolati kliniċi ta' P. aeruginosa, OXA-11 (Turkija) u OXA-45 (Stati Uniti) li jidrolizzaw aztreonam.
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100).
Maltese: Il-frekwenzi huma definiti kif ġej: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10) u mhux komuni (≥ 1/1,000 sa < 1/100).
English: In GS-US-205-0110, 268 patients with CF and chronic P. aeruginosa lung infection were randomised and received Cayston (n = 136) or TNS (n = 132).
Maltese: Fi studju GS-US-205-0110, 268 pazjent bis-CF u infezzjoni pulmonari kronika b'P. aeruginosa ntgħażlu b'mod każwali u rċivew Cayston (n = 136) jew TNS (n = 132).
English: Gilead Sciences Slovakia s.r.o Tel: + 421 232 121 210
Maltese: Slovenská republika Gilead Sciences Slovakia s.r.o Tel: + 421 232 121 210
English: Gilead Sciences Ltd Tel: + 44 (0) 8000 113700
Maltese: United Kingdom Gilead Sciences Ltd Tel: + 44 (0) 8000 113700
English: There are rare reports of organisms with metallo-beta-lactamases (MBLs), Class B, that are resistant to aztreonam, VIM-5 (K. pneumoniae and P. aeruginosa - Turkey), VIM-6 (P. putida - Singapore) and VIM-7 (P. aeruginosa - United States), however, it is possible that these organisms were expressing multiple resistance mechanisms and thus a MBL was not responsible for the observed resistance to aztreonam.
Maltese: Kien hemm rapporti rari ta' organiżmi b'metallo-beta-lactamases (MBLs), Klassi B, li huma reżistenti għal aztreonam, VIM-5 (K. pneumoniae u P. aeruginosa - Turkija), VIM-6 (P. putida - Singapore) u VIM-7 (P. aeruginosa - Stati Uniti), madankollu, hu possibbli li dawn l-organiżmi kienu qed jesprimu mekkaniżmi multipli tar-reżistenza u għaldaqstant MBL ma kienx responsabbli għar-reżistenza osservata għal aztreonam.
English: Aztreonam is not extensively metabolised.
Maltese: Aztreonam ma jiġix metabolizzat b'mod estensiv.
English: • 28-day pack of Cayston
Maltese: • pakkett ta' 28 jum ta' Cayston
English: Sodium chloride Water for injections
Maltese: Sodium chloride Ilma għall-injezzjonijiet
English: Ελλάδα Gilead Sciences Ελλάς Μ.ΕΠΕ.
Maltese: Sewqan u tħaddim ta' magni
English: In a Phase 2 open-label study (GS-US-205-0162), 105 paediatric patients aged 3 months to < 18 years (24 patients aged 3 months to < 2 years; 25 patients aged 2 to < 6 years; 56 patients aged 6 to < 18 years) with CF and documented initial/new onset P. aeruginosa infection/colonisation received Cayston 3 times a day for a single course of 28 days.
Maltese: Fi studju open-label ta' Fażi 2, (GS-US-205-0162), 105 pazjenti pedjatriċi li kellhom minn 3 xhur sa < 18-il sena (24 pazjent b'età minn 3 xhur sa < sentejn; 25 pazjent b'età minn sentejn sa < 6 snin; 56 pazjent b'età minn 6 sa < 18-il sena) bis-CF u infezzjoni/kolonizzazzjoni inizjali/bikrija b'P. aeruginosa dokumentata irċevew Cayston 3 darbiet kuljum għal kors wieħed ta' 28 jum.
English: You can use either an eBase Controller or an eFlow rapid Control Unit with the Altera Handset.
Maltese: Tista' tuża jew eBase Controller jew eFlow rapid Control Unit ma' Altera Handset.
English: The adjusted mean percent change from baseline to Day 28 in FEV1 % predicted was 8.35 and 0.55 in the Cayston and TNS groups, respectively (treatment difference: 7.80; p = 0.0001; 95% CI: 3.86, 11.73).
Maltese: Il-medja aġġustata f'perċentwali tal-bidla mil-linja bażi sa jum 28 f'FEV1 % imbassra kienet 8.35 u 0.55 fil-gruppi ta' Cayston u TNS, rispettivament (differenza fil-kura: 7.80; p = 0.0001; 95% CI: 3.86, 11.73).
English: An acute reduction of ≥ 15% in FEV1 is a complication associated with nebulised therapies, including Cayston (see section 4.4).
Maltese: Tnaqqis akut ta' ≥ 15% fl-FEV1 hi komplikazzjoni assoċjata ma' terapiji li jingħataw bin-nebulizzatur, li jinkludu Cayston (ara sezzjoni 4.4).
English: Other medicines and Cayston
Maltese: Mediċini oħra u Cayston
English: Cayston was evaluated over a period of 28-days of treatment (one course) in two randomised, doubleblind, placebo-controlled, multicentre studies (CP-AI-005 and CP-AI-007).
Maltese: Cayston kien evalwat fuq perjodu ta' 28 jum ta' kura (kors wieħed) f'żewġ studji randomised, doubleblind, ikkontrollati bil-plaċebo, u multiċentriċi (CP-AI-005 u CP-AI-007).