FrancophonIA/ELRC3.0 huggingface dataset:
English: Finland Boehringer Ingelheim International GmbH Binger Strasse 173
Maltese: Il-Finlandja Boehringer Ingelheim International GmbH Binger Strasse 173
English: Ambroxolo Angenerico nebuliser solution inhalation use
Maltese: Ambroxolo Angenerico soluzzjoni għannebulizzatur għal biex jinġibed mannifs
English: Ambroxol acis 60 mg Brausetabletten effervescent tablet oral use
Maltese: Ambroxol acis 60 mg Brausetabletten pillola li tfexfex
English: Bulgaria Boehringer Ingelheim International GmbH Binger Strasse 173
Maltese: Il-Bulgarija Boehringer Ingelheim International GmbH Binger Strasse 173
English: BROMHEXIN 4 BC
Maltese: Germany idroklorur tal-bromhexine BROMHEXIN 4 BC
English: Ambroxol Tecnigen nebuliser solution inhalation use
Maltese: Ambroxol Tecnigen soluzzjoni għannebulizzatur għal biex jinġibed mannifs
English: Romania bromhexine hydrochloride
Maltese: Romania idroklorur tal-bromhexine BROMHEXIN
English: Mucosolvan 60 mg granules for oral solution
Maltese: Mucosolvan 60 mg granijiet għal soluzzjoni orali
English: Bisolvon drank voor kinderen met aardbeiensmaak, 4 mg/5 ml
Maltese: 1817 MS Alkmaar The Netherlands idroklorur tal-bromhexine Bisolvon drank voor kinderen met aardbeiensmaak, 4 mg/5 ml
English: Mucosolvan Bambini suppository rectal use
Maltese: Mucosolvan Bambini suppositorju użu għal ġorrektum
English: Mucosolvan Brausetabletten 60 mg effervescent tablet oral use
Maltese: Mucosolvan Brausetabletten 60 mg pillola li tfexfex
English: Bisolvon 2 mg/ml peroralna raztopina/inhalacijska raztopina za nebulator oral solution/nebuliser solution oral use, inhalation use
Maltese: D-55216 Ingelheim am Rhein Germany idroklorur tal-bromhexine Bisolvon 2 mg/ml peroralna raztopina/inhalacijska raztopina za nebulator soluzzjoni orali/soluzzjoni għan-nebulizzatur użu orali, għal biex jinġibed mannifs
English: BROMHEXIN 12 BC
Maltese: Germany idroklorur tal-bromhexine Bromhexin 12 BC
English: Bromhexin 12 BC
Maltese: Germany idroklorur tal-bromhexine BROMHEXIN 12 BC
English: Slovenia Boehringer Ingelheim International GmbH Binger Strasse 173
Maltese: Is-Slovakkja Boehringer Ingelheim International GmbH Binger Strasse 173
English: Bromexina Pharmentis
Maltese: Germed Pharma
English: Hoesttabletten Broomhexine HCl 8 mg HTP Huisapotheek, tabletten
Maltese: ETTEN-LEUR The Netherlands idroklorur tal-bromhexine Hoesttabletten Broomhexine HCl 8 mg HTP Huisapotheek, tabletten
English: Lithuania Boehringer Ingelheim International GmbH Binger Strasse 173
Maltese: Il-Litwanja Boehringer Ingelheim International GmbH Binger Strasse 173
English: 120 mg prolonged-release capsule, hard
Maltese: 120 mg kapsula li terħi lmediċina bil-mod, iebsa
English: Lithuania CYATHUS Exquirere Pharmaforschungs GmbH Rudolfsplatz 2/1/8
Maltese: Il-Litwanja CYATHUS Exquirere Pharmaforschungs GmbH Rudolfsplatz 2/1/8
English: Croatia bromhexinum Bisolex 8 mg tablete
Maltese: Latvia idroklorur tal-bromhexine Bromhexin Sopharma 8 mg tablets
English: Kruidvat HOESTDRANK Broomhexine HCl 4 mg/ 5ml suikervrij, drank
Maltese: HCl 8 mg/ 5ml suikervrij, drank
English: France bromhexine (chlorhydrate de)
Maltese: (kloridrat tal-) bromhexine
English: Ambroxol retard Temmler 75mg prolonged-release capsule, hard
Maltese: Ambroxol retard Temmler 75mg kapsula li terħi lmediċina bil-mod, iebsa
English: Mucosolvan Retardkapseln 75 mg prolonged-release capsule, hard
Maltese: Mucosolvan Retardkapseln 75 mg kapsula li terħi lmediċina bil-mod, iebsa
English: Leidapharm Hoestdrank Broomhexine HCl 4 mg/5 ml suikervrij, drank
Maltese: Archimedesweg 2 2333 CN LEIDEN The Netherlands idroklorur tal-bromhexine Leidapharm Hoestdrank Broomhexine HCl 4 mg/5 ml suikervrij, drank
English: IDYL Hoestdrank Broomhexine HCl 4 mg/5 ml, drank
Maltese: 1112 BA DIEMEN The Netherlands idroklorur tal-bromhexine IDYL Hoestdrank Broomhexine HCl 4 mg/5 ml, drank
English: 1817 MS Alkmaar The Netherlands bromhexine hydrochloride
Maltese: 1817 MS Alkmaar The Netherlands idroklorur tal-bromhexine Bisolvon druppels voor kinderen, oplossing 2 mg/ml
English: PAXIRASOL 2 mg/ml oldatos injekció solution for injection intravenous use, intramuscular use, subcutaneous use
Maltese: PAXIRASOL 2 mg/ml oldatos injekció soluzzjoni għallinjezzjoni użu għal ġol-vini, użu għal ġolmuskoli, użu għal taħt il-ġilda
English: Berlin-Chemie AG Glienicker Weg 125
Maltese: Il-Ġermanja Berlin-Chemie AG Glienicker Weg 125
English: AMBROBENE 7,5 mg/ml oldatos injekció solution for injection intravenous use, intramuscular use, subcutaneous use
Maltese: AMBROBENE 7,5 mg/ml oldatos injekció soluzzjoni għallinjezzjoni użu għal ġol-vini, użu għal ġolmuskoli, użu għal taħt il-ġilda
English: Leidapharm Hoestdrank Extra sterk Broomhexine HCl 8 mg/5 ml suikervrij, drank
Maltese: Archimedesweg 2 2333 CN LEIDEN The Netherlands idroklorur tal-bromhexine Kruidvat HOESTDRANK Extra sterk Boomhexine HCl 8 mg/5 ml suikervrij, drank
English: Latvia bromhexine hydrochloride
Maltese: Italy idroklorur tal-bromhexine Flutoxil
English: Mucosolvan retard 75 mgKapseln prolonged-release capsule, hard
Maltese: Mucosolvan retard 75 mgKapseln kapsula li terħi lmediċina bil-mod, iebsa
English: Noordwijk
Maltese: Wynn
English: Ambroxine lozenge oropharyngeal use
Maltese: Ambroxol Genericon Saft likwidu orali
English: nasal spray, solution nasal use
Maltese: qtar orali, soluzzjoni użu orali
English: The Netherlands bromhexine hydrochloride
Maltese: The Netherlands idroklorur tal-bromhexine Bronchi-Mereprine
English: BROMHEXIN FARMACOM 8 mg
Maltese: Romania idroklorur tal-bromhexine BROMHEXIN FARMACOM 8 mg
English: Flavamed 60mg Brausetabletten effervescent tablet oral use
Maltese: Flavamed 60mg Brausetabletten pillola li tfexfex
English: Kruidvat HOESTDRANK Extra sterk Boomhexine HCl 8 mg/5 ml suikervrij, drank
Maltese: HCl 8 mg/5 ml suikervrij, drank
English: Mucoangine Cassis lozenge
Maltese: Mucosolvan gamm tal-ħalq
English: Ambex effervescent tablet oral use
Maltese: Ambex pillola li tfexfex
English: Trekpleister hoesttabletten bij vastzittende hoest 8, tabletten 8 mg
Maltese: Archimedesweg 2 2333 CN LEIDEN The Netherlands idroklorur tal-bromhexine Trekpleister hoesttabletten bij vastzittende hoest 8, tabletten 8 mg
English: Germany Cyathus Exquirere PharmaforschungsGmbH Rudolfplatz 2/1/8
Maltese: Il-Ġermanja Cyathus Exquirere PharmaforschungsGmbH Rudolfplatz 2/1/8
English: Mucosolvan Lutschpastillen 15 mg pastille oromucosal use
Maltese: Mucosolvan Lutschpastillen 15 mg pastilja użu għallmukuża tal-ħalq
English: Hungary Divapharma GmbH Motzener Str. 41
Maltese: Il-Ġermanja Divapharma GmbH Motzener Str.
English: Lizipadol 20 mg pastillas para chupar lozenge oromucosal use
Maltese: Lizipadol 20 mg pastillas para chupar mustardina mediċinali użu għallmukuża tal-ħalq
English: 1 singledose container
Maltese: 1 kontenitur b'doża waħda
English: It may harm them,
Maltese: Bucureşti-Ploieşti,
English: 2770-192 Paço d' Arcos Portugal
Maltese: 2770-192 Paço d' Arcos Il-Portugall
English: Corp clădire C1, Etaj 3, Sector 1, Bucureşti Romania
Maltese: Corp clădire C1, Etaj 3, Sector 1, Bucureşti
English: Skanstes 13, second floor, LV- 1013, Riga Latvia
Maltese: Skanstes 13, second floor, LV- 1013, Riga Il-Latvja
English: Istituto Gentili S.p.A Via B. Croce, 37 56125 Pisa Italy
Maltese: Istituto Gentili S.p.A Via B. Croce, 37 56125
English: 1407 Sofia Bulgaria
Maltese: 1407 Sofia Il-Bulgarija
English: Distribution.
Maltese: Distribuzzjoni.
English: Tatoiou Street, Nea Erythrea, 146 71, Greece
Maltese: Tatoiou Street, Nea Erythrea, 146 71, Il-Greċja
English: Granules 7 x 1 sachet 20 x 1 sachet 28 x 1 sachet 30 x 1 sachet
Maltese: 7 x 1 qartas 20 x 1 qartas 28 x 1 qartas 30 x 1 qartas
English: MSD Magyarország Kft. 1123 Budapest, Alkotás u. 50., Hungary
Maltese: MSD Magyarország Kft. 1123 Budapest, Alkotás u. 50., L-Ungerija
English: Elimination.
Maltese: Eliminazzjoni.
English: Donau-City-Straße 6 1220 Wien
Maltese: Donau-City-Straße 6
English: Dieckmann Arzneimittel GmbH, Lindenplatz 1 85540 Haar
Maltese: Dieckmann Arzneimittel GmbH, Lindenplatz 1 85540
English: 28027 - Madrid Spain
Maltese: 28027 - Madrid Spanja
English: 28027- Madrid Spain
Maltese: 28027- Madrid Spanja
English: Montelukast is more than 99% bound to plasma proteins.
Maltese: Montelukast jeħel aktar minn 99% mal-proteini tal-plasma.
English: Mannitol, microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry flavour, aspartame (E951), and magnesium stearate.
Maltese: Mannitol, microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry flavour, aspartame (E951), u magnesium stearate.
English: Both were of doubleblind, randomised, parallel-group type.
Maltese: It-tnejn kienu tattip double-blind, randomizzati, bi gruppi paralleli.
English: • The active substance is montelukast.
Maltese: • Is-sustanza attiva hi montelukast.
English: EXCIPIENT: ASPARTAME (E 951) 1.2 MG PER TABLET.
Maltese: Aspartame (E 951) 1.2 mg kull pillola.
English: Box 214
Maltese: P.O. Box 214
English: Singulair 4 mg oral granules was approved by 16 member states (not by AT, BE, CZ, DK, FR, HU, NL, PL, SK) in MRP in 2002.
Maltese: Ilgranuli orali ta' Singulair ta' 4 mg kienu approvati minn 16-il Stat Membru (mhux minn AT, BE, CZ, DK, FR, HU, NL, PL, SK) fl-MRP fl-2002.
English: “Merck Sharp & Dohme”, UAB, Kestucio str. 59/27 LT-08124 Vilnius Lithuania
Maltese: “Merck Sharp & Dohme”, UAB, Kestucio str. 59/27 LT-08124 Vilnius Il-Litwanja
English: The mean oral bioavailability is 64%.
Maltese: Il-bijodisponibilità medja orali hija ta' 64%.
English: Absorption.
Maltese: Assorbiment.
English: Singulair 4 mgKautabletten für Kleinkinder
Maltese: 4 mgKautabletten für Kleinkinder
English: Bulgaria, Cyprus, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Norway, Portugal, Romania, Slovenia, Spain, Sweden, United Kingdom: SINGULAIR
Maltese: Il-Bulgarija, Ċipru, l-Estonja, il-Finlandja, il-Ġermanja, il-Greċja, l-Islanda, l-Irlanda, l-Italja, ilLatvja, il-Litwanja, il-Lussemburgu, Malta, in-Norveġja, il-Portugall, ir-Rumanija, is-Slovenja, Spanja, l-Isvezja, ir-Renju Unit
English: Montelukast is extensively metabolized.
Maltese: Montelukast jiġi metabolizzat b'mod estensiv.
English: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovak Republic, Spain, Sweden, United Kingdom
Maltese: L-Awstrija, il-Belġju, il-Bulgarija, Ċipru; ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Finlandja, il-Ġermanja, il-Greċja, l-Ungerija, l-Islanda, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, l-Olanda, in-Norveġja, il-Polonja, il-Portugall, ir-Rumanija, is-Slovenja, ir-Repubblika Slovakka, Spanja, l-Isvezja, ir-Renju Unit
English: FEV1 increased from 1.83 L to 2.09 L in the montelukast group and from 1.85 L to 2.14 L in the fluticasone group.
Maltese: FEV1 żdied minn 1.83 L għal 2.09 L fil-grupp ta' montelukast u minn 1.85 L għal 2.14 L fil-grupp ta' fluticasone.
English: • The other ingredients are: Mannitol, hyprolose (E 463), and magnesium stearate.
Maltese: Mannitol, hyprolose (E 463), u magnesium stearate.
English: PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 chewable tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 pillola li tomgħodha
English: • To be taken by mouth
Maltese: • ġilda qxur qxur u li tieklok
English: The mean oral bioavailability is 73% and is decreased to 63% by a standard meal.
Maltese: Ilbijodisponibilità orali medja hija ta' 73% u tonqos għal 63% b'ikla standard.
English: • phenobarbital (used for treatment of epilepsy)
Maltese: • phenobarbital (użat għat-trattament ta' l-epilessija)
English: Further efficacy reports of two clinical studies (P176 and P072-02; double-blind, randomized, placebo-controlled, parallel group) were presented for both 4mg OG and CT formulations.
Maltese: Rapporti oħra ta' l-effikaċja ta' żewġ studji kliniċi (P176 u P072-02; grupp parallel, double-blind, randomatizzat, ikkontrollat bi plaċebo) ġew ippreżentati għall-formolazzjonijiet ta' OG u CT4mg.
English: The steady-state volume of distribution of montelukast averages 8-11 liters.
Maltese: Il-volum tad-distribuzzjoni fiss ta' montelukast huwa bħala medja 8-11 -il litru.
English: The between group difference in LS means was significant: 7.3% with a 95%CI of 2.9; 11.7.
Maltese: 7.3% b'95% CI ta' 2.9; 11.7.
English: The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils.
Maltese: Is-cysteinyl leukotrienes (LTC4, LTD4, LTE4) huma eicosanoids infjammatorji qawwija merħija minn diversi ċelloli fosthom il-mast cells u l-esinofili.
English: SINGULAIR contains aspartame, a source of phenylalanine.
Maltese: SINGULAIR fih aspartame, li huwa sors ta' phenylalanine.
English: Merck Sharp & Dohme B.V. Chaussée de Waterloo 1135 B- 1180 Brussels Belgium
Maltese: Merck Sharp & Dohme B.V. Chaussée de Waterloo 1135 B- 1180 Brussell Il-Belġju
English: Blisters in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.
Maltese: Folji f'pakketti ta': 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 u 200 pillola.
English: Blisters (unit doses), in packages of: 49, 50 and 56 tablets.
Maltese: Folji (dożi singoli), f'pakketti ta': 49, 50 u 56 pillola.
English: 4 mg Granules
Maltese: 4 mg Granuli
English: 11415 Tallinn Estonia
Maltese: Tallinn L-Estonja
English: In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following medicinal products: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
Maltese: Fi studji dwar l-interazzjonijiet tal-mediċina, id-doża klinika rakkomandata ta' montelukast ma kellhiex effetti kliniċi importanti fuq il-farmakokinetiċi tal-prodotti mediċinali li ġejjin: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin u warfarin.
English: LIST OF EXCIPIENTS Contains aspartame (E 951).
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Fih aspartame (E 951).
English: Cartons of 7, 20, 28 and 30 sachets.
Maltese: Pakketti ta' 7, 20, 28 u 30 qartas.
English: Pharmacotherapeutic group: Leukotriene receptor antagonist ATC-code: R03D C03
Maltese: Antagonista tar-riċetturi leukotriene Kodiċi ATC:
English: The MAH provided harmonised modules 3 in CTD format for Singulair 4 mg granules and 4 mg chewable tablets.
Maltese: Il-MAH ipprovda moduli armonizzati 3 fil-format CTD għal Singulair 4 mg granuli u 4 mg pilloli jintmagħdu.
English: SPC Harmonisation
Maltese: Armonizzazzjoni ta' l-SPC
English: Merck Sharp and Dohme Bulgaria EOOD 55, Nikola Vaptzarov blvd. EXPO 2000, east wing, sectors B1&B2, 1st fl.
Maltese: Merck Sharp and Dohme Bulgaria EOOD 55, Nikola Vaptzarov blvd. EXPO 2000, east wing, sectors B1&B2, 1
English: The active substance in Singulair products is montelukast sodium.
Maltese: Is-sustanza attiva fil-prodotti Singulair hija montelukast sodium.
English: In monkeys, the adverse effects appeared at doses from 150 mg/kg/day (>232-fold the systemic exposure seen at the clinical dose).
Maltese: Fixxadini, l-effetti avversi dehru b'dożi minn 150 mg/kg/ġurnata (>232 darba l-esponiment sistemiku muri bid-doża klinika).
English: Hepatobiliary disorders: elevated levels of serum transaminases (ALT, AST), cholestatic hepatitis.
Maltese: Disturbi fil-fwied u fil-marrara: livelli għoljin ta' transaminases fis-serum (ALT, AST), epatite kolestatika.
English: The mean Cmax is 66% higher while mean Cmin is lower than in adults receiving a 10 mg tablet.
Maltese: Il-Cmax medja hija 66% ogħla filwaqt li l-Cmin medja hija aktar baxxa f'pazjenti adulti li jirċievu pillola ta' 10 mg.
English: The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients.
Maltese: Is-sejbiet kliniċi u osservati fil-laboratorju kienu konsistenti malprofil tas-sigurtà f'pazjenti adulti u pedjatriċi.
English: • phenytoin (used for treatment of epilepsy)
Maltese: • phenytoin (użat għat-trattament ta' l-epilessija)
English: Bucureşti-Ploieşti, nr.1A,
Maltese: nr.1A,
English: Adult Patients 15 years and older (two 12-week studies; n=795)
Maltese: Pazjenti Adulti 15-il sena u aktar (żewġ studji ta' 12-il ġimgħa; n=795)
English: Paediatric Patients 2 to 5 years old (one 12-week study; n=461) (one 48-week study; n=278)
Maltese: Pazjenti Pedjatriċi 2 sa 5 snin (studju wieħed ta' 12-il ġimgħa; n=461) (studju wieħed ta' 48 ġimgħa; n=278)
English: INFORMATION IN BRAILLE SINGULAIR 4 mg
Maltese: INFORMAZZJONI BIL-BRAILLE SINGULAIR 4 mg
English: The co-administration of applesauce or a high-fat standard meal with the granule formulation did not have a clinically meaningful effect on the pharmacokinetics of montelukast as determined by AUC (1225.7 vs 1223.1 ng.hr/mL with and without applesauce, respectively, and 1191.8 vs 1148.5 ng.hr/mL with and without a high-fat standard meal, respectively).
Maltese: L-għoti ta' zalza tat-tuffieħ jew ikla standard b'kontenut għoli ta' xaħam mal-formulazzjoni tal-granuli ma kellux effett kliniku sinifikanti fuq il-farmakokinetiċi ta' montelukast kif stabbilit mill-AUC (1225.7 vs 1223.1 ng.hr/mL bi u mingħajr zalza tat-tuffieħ, rispettivament, u 1191.8 vs 1148.5 ng.hr/mL bi u mingħajr ikla standard b'kontenut għoli ta' xaħam, rispettivament).
English: Based on further in vitro results in human liver microsomes, therapeutic plasma concentrations of montelukast do not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6.
Maltese: Fuq il-bażi ta' aktar riżultati in vitro fuq mikrosomi tal-fwied uman, konċentrazzjonijiet terapewtiċi ta' montelukast fil-plasma ma jwaqqfux iċ-ċitokromi P450 3A4, 2C9, 1A2, 2A6, 2C19, jew 2D6.
English: The following revision to Section 4.2 of Singulair 4 mg OG SPC was finally accepted:
Maltese: Ir-reviżjoni li ġejja għas-Sezzjoni 4.2 ta' l-SPC ta' Singulair 4 mg OG kienet finalment aċċettata:
English: The percentage of days with β-agonist use decreased from 38.0 to 15.4 in the montelukast group, and from 38.5 to 12.8 in the fluticasone group.
Maltese: Il-perċentwali ta' ġranet b'użu ta' β-agonist naqsu minn 38.0 għal 15.4 fil-grupp ta' montelukast, u minn 38.5 għal 12.8 fil-grupp ta' fluticasone.
English: Montelukast was neither mutagenic in in vitro and in vivo tests nor tumorigenic in rodent species.
Maltese: Montelukast la kien mutaġeniku f'testijiet in vitro u in vivo u lanqas tumoriġeniku fi speċijiet gerriema.
English: Body System Class
Maltese: Klassifika tas-Sistema talĠisem
English: With high doses of montelukast (20- and 60-fold the recommended adult dose), a decrease in plasma theophylline concentration was observed.
Maltese: B'dożi għoljin ta' montelukast (20 u 60 darba d-doża rakkomandata għall-adulti), kien osservat tnaqqis fil-konċentrazzjoni ta' theophylline fil-plasma.
English: Study P910 (treatment duration 52 weeks) was carried out in 6 to 14-year old paediatric patients, study P907 in patients 2 to 6 years old.
Maltese: L-istudju P910 (bi trattament ta' 52 ġimgħa) sar f'pazjenti ta' bejn 6 u 14-il sena, studju P907 f'pazjenti ta' bejn sentejn u sitt snin.
English: Paediatric Patients 6 to 14 years old (one 8-week study; n=201) (two 56-week studies; n=615)
Maltese: Pazjenti Pedjatriċi 6 sa 14-il sena (studju wieħed ta' 8 ġimgħat; n=201) (żewġ studji ta' 56 ġimgħa; n=615)
English: White granules
Maltese: Granuli bojod
English: The between-group difference in LS mean increase in FEV1 was -0.02 L with a 95% CI of -0.06, 0.02.
Maltese: 02 L b'95% CI ta' -0.06, 0.02.
English: SINGULAIR, granule, 4 mg/plic
Maltese: Singulair, granule, 4 mg/plic 4 mg Granuli
English: Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, the United Kingdom
Maltese: Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, IrRenju Unit
English: Gastrointestina l disorders abdominal pain abdominal pain diarrhoea
Maltese: Disturbi gastrointestinali uġigħ addominali uġigħ addominali dijarea
English: In a trend voting after the Applicant/MAH's Oral Explanation, the majority of the CHMP (26+2 positive, 3 negative votes) was in favour of accepting the indication as proposed by the Applicant/MAH, including the treatment of very young patients (6 months to 2 year old) when diagnosis of persistent asthma has been established.
Maltese: F'votazzjoni tat-tendenza wara l-Ispjegazzjoni Orali ta' l-Applikant/MAH, ilmaġġoranza tas-CHMP (26+2 pożittivi, 3 voti negattivi) kienet favur l-aċċettazzjoni ta' l-indikazzjoni kif proposta mill-Applikant/MAH, inkluż it-trattament ta' pazjenti żgħar ħafna (ta' bejn 6 xhur u sentejn) meta tkun ġiet stabbilita d-dijanjożi ta' ażżma persistenti.
English: 4 mg chewable tablets are available as an alternative formulation for paediatric patients 2 to 5 years of age.
Maltese: Pilloli li tomgħodhom ta' 4 mg huma disponibbli bħala formulazzjoni alternattiva għal pazjenti pedjatriċi minn 2 sa 5 snin.
English: In vitro studies using human liver microsomes indicate that cytochrome P450 3A4, 2A6 and 2C9 are involved in the metabolism of montelukast.
Maltese: Studji in vitro li jużaw mikrosomi tal-fwied uman jindikaw li ċ-ċitokromi P459 3A4, 2A6 u 2C9 huma involuti fil-metaboliżmu ta' montelukast.
English: In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8.
Maltese: Studji in vitro wrew li montelukast huwa inibitur qawwi ta' CYP 2C8.
English: • rifampicin (used to treat tuberculosis and some other infections) Taking SINGULAIR with food and drink
Maltese: • rifampicin (użat għat-trattament tat-tuberkulożi u xi infezzjonijiet oħra)
English: Formulations for paediatric use, 4 mg chewable tablets and 4 mg oral granules, have been available since 2000 and 2002, respectively.
Maltese: Formulazzjonijiet għal użu fit-tfal, pilloli jintmagħdu ta' 4 mg u granuli orali ta' 4 mg, ilhom jeżistu mill-2000 u l-2002 rispettivament.
English: 10 mg film-coated tablets in approximately 4000 adult patients 15 years of age and older 5 mg chewable tablets in approximately 1750 paediatric patients 6 to 14 years of age, and 4 mg chewable tablets in 851 paediatric patients 2 to 5 years of age.
Maltese: 10 mg pilloli miksijin b'rita f'madwar 4000 pazjent adult ta' 15 -il sena jew aktar 5 mg pilloli li tomgħodhom f'madwar 1750 pazjent pedjatriku minn 6 sa 14 -il sena, u 4 mg pilloli li tomgħodhom fi 851 pazjent pedjatriku minn 2 sa 5 snin.
English: The SPCs proposed by the MAH were those approved through the MRP in the "old" member states and in CY and IS.
Maltese: L-SPCs proposti mill-MAH kienu dawk approvati mill-MRP fl-Istati Membri l-“antiki” u f'CY u flIS.
English: Psychiatric disorders: dream abnormalities including nightmares, hallucinations, insomnia, psychomotor hyperactivity (including irritability, restlessness, agitation including aggressive behaviour, and tremor), depression, suicidal thinking and behaviour (suicidality) in very rare cases.
Maltese: Disturbi psikjatriċi: anormalitajiet tal-ħolm fosthom inkubi, alluċinazzjonijiet, nuqqas ta' rqad, attività psikomotorili eċċessiva (inkluż irritabilità, irrekwitezza, aġitazzjoni li tinkludi mġiba aggressiva, u rogħda), depressjoni, ħsibijiet u mġiba suwiċidjali (suwiċidjalità f'każijiet rari ħafna).
English: The mean increase from baseline in % predicted FEV1 was 0.6% in the montelukast treatment group, and 2.7% in the fluticasone treatment group.
Maltese: Iż-żieda medja mil-linja bażi f'perċentwali mbassra ta' FEV1 kienet ta' 0.6% fil-grupp ta' trattament b'montelukast, u 2.7% fil-grupp ta' trattament bi fluticasone.
English: No deaths occurred following a single oral administration of montelukast sodium at doses up to 5000 mg/kg in mice and rats (15,000 mg/m2 and 30,000 mg/m2 in mice and rats, respectively), the maximum dose tested.
Maltese: Ma seħħew ebda mwiet wara għoti orali wieħed ta' montelukast sodium f'dożi sa 5000 mg/kg filġrieden u l-firien (15,000 mg/m2 u 30,000 mg/m2 fil-ġrieden u l-firien, rispettivament), l-akbar doża ttestjata.