FrancophonIA/ELRC3.0 huggingface dataset:
English: The following side effects have been reported in patients taking Cholestagel:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati f'pazjenti li kienu qed jieħdu Cholestagel:
English: However no interaction was observed when Cholestagel was administered four hours after the oral contraceptive pill.
Maltese: Din l-interazzjoni kienet osservata wkoll meta Cholestagel ngħata siegħa wara l-pillola kontraċettiva orali.
English: These could include poorly controlled diabetes, untreated hypothyroidism (low levels of thyroid hormone for which no treatment is being given currently), proteins in urine (nephrotic syndrome), altered protein levels in the blood (dysproteinaemias), and blockage of the bile transport to your gall bladder (obstructive liver disease).
Maltese: Dawn jinkludu dijabete li mhix ikkontrollata tajjeb, ipotirojdiżmu (livelli baxxi ta' l-ormon tat-tirojde li bħalissa mhix qed tingħata kura għalih) mhux ikkurat, proteina fl-awrina (sindromu nefrotiku), bidla fil-livelli tal-proteina fid-demm
English: When a drug interaction cannot be excluded with a concomitant medicinal product for which minor variations in the therapeutic level would be clinically important, or where no clinical data are available on co-administration, Cholestagel should be administered at least four hours before or at least four hours after the concomitant medication in order to minimize the risk of reduced absorption of the concomitant medication (see section 4.5).
Maltese: Cholestagel għandu jingħata mill-inqas 4 sigħat qabel jew mill-inqas erba' sigħat wara li tittieħed il-mediċina fl-istess ħin biex jiġi jitnaqqas ir-riskju ta' tnaqqis fl- assorbiment tal-mediċina użata fl-istess ħin (ara sezzjoni 4.5).
English: This is especially important for patients with coronary heart disease and angina pectoris.
Maltese: Dan hu importanti speċjalment għal pazjenti b'mard koronarju tal-qalb u anġina pectoris.
English: If you are prescribed Cholestagel and any other medicine together you must also read the patient information leaflet that comes with that particular medicine before you start to take your medicine.
Maltese: Jekk int qed tieħu Cholestagel u waħda minn dawn il-mediċini, it-tabib tiegħek għandu mnejn ikun irid jagħmel testijiet biex jkun ċert li Cholestagel ma jinterferixxix ma' dawn il-mediċini.
English: Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
Maltese: Desloratadine jeħel b'mod moderat (83%-87%) mal-proteini tal-plażma.
English: ● aggression
Maltese: ● aggressjoni
English: Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
Maltese: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Il-Belġju.
English: ● insomnia
Maltese: ● insomnja
English: Hallucinations Abnormal behaviour, aggression
Maltese: Alluċinazzjonijiet Imġiba mhux normali, aggressjoni
English: 2220 Heist-op-den-Berg Belgium
Maltese: Heist-op-den-Berg
English: Date of first authorisation: 15 January 2001 Date of latest renewal: 15 January 2006
Maltese: Data tal-aħħar tiġdid: 15 ta' Jannar 2006
English: Contains propylene glycol and sorbitol.
Maltese: Fih propylene glycol u sorbitol.
English: Excipient(s) with known effect: This medicine contains mannitol and aspartame (E951).
Maltese: Din il-mediċina fiha mannitol u aspartame (E951).
English: Common Very rare
Maltese: Rari ħafna
English: Pharmacotherapeutic group: antihistamines - H1 antagonist, ATC code: R06A X27
Maltese: Kategorija farmakoterapewtika: antiistamini - antagonista ta' H1, Kodiċi ATC:
English: Contains mannitol and aspartame.
Maltese: TA' EĊĊIPJENTI Fiha mannitol u aspartame.
English: Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc.
Maltese: Qalba tal-pillola: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc.
English: Frequencies are defined as 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 (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala 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 (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Children 1 through 5 years of age:
Maltese: Tfal minn sena sa 5 snin:
English: 6.1 List of excipients microcrystalline cellulose pregelatinized starch sodium starch glycolate magnesium stearate butylated methacrylate copolymer crospovidone sodium hydrogen carbonate citric acid colloidal silicon dioxide ferric oxide mannitol aspartame (E951) flavour Tutti-Frutti
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti microcrystalline cellulose pregelatinized starch sodium starch glycolate magnesium stearate butylated methacrylate copolymer crospovidone sodium hydrogen carbonate citric acid colloidal silicon dioxide ferric oxide mannitol aspartame (E951) Togħma ta' Tutti-Frutti
English: Desloratadine is the primary active metabolite of loratadine.
Maltese: Desloratadine huwa l-metabolit attiv ewlieni ta' loratadine.
English: Other medicines and Aerius
Maltese: Mediċini oħra u Aerius
English: Common Common (children less than 2 years) Very rare
Maltese: Komuni Komuni (tfal ta' inqas minn sentejn) Rari ħafna
English: Aerius tablets contain lactose.
Maltese: Din il-mediċina fiha lactose.
English: In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving placebo.
Maltese: Fi prova klinika b'578 pazjent adolexxenti, b'età minn 12 sa 17-il sena, l-aktar każ avvers komuni kien uġigħ ta' ras; dan seħħ f'5.9% tal-pazjenti kkurati b'desloratadine u f'6.9% tal-pazjenti li kienu qed jirċievu plaċebo.
English: Aerius 0.5 mg/ml oral solution
Maltese: Aerius 0.5 mg/ml soluzzjoni orali
English: Aerius oral solution contains sorbitol
Maltese: Aerius soluzzjoni orali fiha sorbitol
English: Children 1 through 5 years of age: 2.5 ml (1.25 mg) Aerius oral solution once a day.
Maltese: Tfal minn sena sa 5 snin : 2.5 ml (1.25 mg) Aerius soluzzjoni orali darba kuljum.
English: Children 6 through 11 years of age: 5 ml (2.5 mg) Aerius oral solution once a day.
Maltese: Tfal minn 6 snin sa 11-il sena: 5 ml (2.5 mg) Aerius soluzzjoni orali darba kuljum.
English: ● muscle pain
Maltese: ● uġigħ fil-muskoli
English: MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
Maltese: Tlf: + 45 4482 4000 dkmail@merck.com
English: Aerius 0.5 mg/ml oral solution desloratadine
Maltese: Aerius 0.5 mg/ml soluzzjoni orali desloratadine
English: Aerius contains lactose
Maltese: Aerius fih lactose
English: Desloratadine does not readily penetrate the central nervous system.
Maltese: Desloratadine ma jippenetrax malajr fis-sistema nervuża ċentrali.
English: Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Maltese: Sturdament, sonnolenza, nuqqas ta' rqad, iperattività psikomotorjali, aċċessjonijiet
English: Efficacy of Aerius oral solution has not been investigated in separate paediatric trials.
Maltese: L-effikaċja tas-soluzzjoni orali Aerius ma ġietx investigata fi provi pedjatriċi separati.
English: - The active substance is desloratadine 0.5 mg/ml - The other ingredients of the oral solution are sorbitol, propylene glycol, sucralose E 955, hypromellose 2910, sodium citrate dihydrate, natural and artificial flavour (bubblegum), citric acid anhydrous, disodium edetate and purified water.
Maltese: - Is-sustanza attiva hi desloratadine 0.5 mg/ml - Is-sustanzi l-oħra tas-soluzzjoni orali huma sorbitol, propylene glycol, sucralose E 955, hypromellose 2910, sodium citrate dihydrate, essenza naturali u artifiċjali (babbilgamm), citric acid anhydrous, disodium edetate u ilma purifikat.
English: Aerius oral solution contains sorbitol.
Maltese: Aerius soluzzjoni orali fiha sorbitol.
English: Treatment was well tolerated as documented by clinical laboratory tests, vital signs, and ECG interval data, including QTc.
Maltese: Il-kura kienet ittollerata tajjeb kif deher minn testijiet kliniċi tal-laboratorju, sinjali vitali, u dejta tal-intervall tal-ECG, inkluż QTc.
English: In infants and toddlers aged 6 to 23 months, the most frequent adverse reactions reported in excess of placebo were diarrhoea (3.7 %), fever (2.3 %) and insomnia (2.3 %).
Maltese: Fi trabi żgħar u tfal żgħar ta' etajiet minn 6 sa 23 xahar, l-aktar reazzjonijiet avversi frekwenti rrappurtati iżjed ta' spiss millplaċebo kienu dijarea (3.7%), deni (2.3%) u nuqqas ta' rqad (2.3%).
English: BOTTLE OF 30 ML, 50 ML, 60 ML, 100 ML, 120 ML, 150 ML, 225 ML, 300 ML
Maltese: ML, 150 ML, 225
English: Desloratadine plasma concentrations can be detected within 30 minutes of desloratadine administration in adults and adolescents.
Maltese: Il-konċentrazzjonijiet ta' desloratadine fil-plażma jkunu jistgħu jitkejlu fi żmien 30 minuta minn meta jingħata f'adulti u adolexxenti.
English: The overall incidence of adverse events in children 2 through 11 years of age was similar for the desloratadine and the placebo groups.
Maltese: L-inċidenza globali ta' każi avversi fi tfal minn sentejn sa 11-il sena kienet simili għal gruppi fuq desloratadine u dawk fuq plaċebo.
English: In a series of pharmacokinetic and clinical trials, 6 % of the subjects reached a higher concentration of desloratadine.
Maltese: F'serje ta' provi farmakokinetiċi u kliniċi, 6% tal-individwi kisbu konċentrazzjoni ogħla ta' desloratadine.
English: Aerius oral solution, is supplied in 30, 50, 60, 100, 120, 150, 225 and 300 ml size Type III amber glass bottles closed with a plastic child resistant (C/R) screw closure having a multi-ply polyethylenefaced liner.
Maltese: Aerius soluzzjoni orali, jiġi fi fliexken tal-ħġieġ kulur l-ambra tat-Tip III ta' daqsijiet ta' 30, 50, 60, 100, 120, 150, 225 u 300 ml, magħluqin b'għatu tal-plastik b'kamin li ma jistax jinfetaħ mit-tfal (C/R) li fih inforra b'ħafna saffi b'faċċata tal-polyethylene.
English: Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 tablets.
Maltese: Pakketti ta' 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 pillola.
English: Aerius given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Maltese: Aerius mogħti bħala doża waħda kuljum ta' 7.5 mg ma affettwax ilprestazzjonijiet psikomotorei fi provi kliniċi.
English: Aerius 2.5 mg orodispersible tablet is light red, speckled, and round with “K” branded on one side.
Maltese: Aerius 2.5 mg pillola li tinħall fil-ħalq hija ħamra ċara, ittikkjata, u tonda immarkata b'“K” fuq naħa.
English: 6.1 List of excipients sorbitol, propylene glycol, sucralose E 955, hypromellose 2910,
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti sorbitol, propylene glycol,
English: Excipient(s) with known effect: This medicinal product contains 150 mg/ml of sorbitol
Maltese: Dan il-prodott mediċinali fih 150 mg/ml ta' sorbitol
English: This medicinal product contains sorbitol; thus, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Dan il-prodott mediċinali fih sorbitol; għalhekk, pazjenti li għandhom problemi ereditarji rari ta' intolleranza għal fructose, malassorbiment tal-glucose-galactose jew nuqqas ta' sucrase-isomaltase, m'għandhomx jieħdu din il-mediċina.
English: Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1receptor antagonist activity.
Maltese: Desloratadine huwa antagonist ta' istamina li ma jħeddilx u li jaħdem fit-tul b'attività antagonista selettiva għar-riċettur-H1 periferali.
English: Adults and adolescents (12 years of age and over)
Maltese: Adulti u adolexxenti (minn 12-il sena 'il fuq)
English: There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Maltese: Hemm esperjenza limitata dwar l-effikaċja minn provi kliniċi bl-użu ta' desloratadine f'adolexxenti minn 12 sa 17-il sena (ara sezzjonijiet 4.8 u 5.1).
English: Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
Maltese: Desloratadine ma jimpedixxix CYP3A4 in vivo, u studji in vitro wrew li l-prodott mediċinali ma jimpedixxix CYP2D6 u la huwa substrat u l-anqas inibitur tal-glikoproteina-P.
English: The bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.
Maltese: Il-bijodisponibilità ta' desloratadine kienet proporzjonali għad-doża fuq il-medda ta' 5 mg sa 20 mg.
English: The prevalence of this poor metaboliser phenotype was comparable for adult (6 %) and paediatric subjects 2- to 11-year old (6 %), and greater among Blacks (18 % adult, 16 % paediatric) than Caucasians (2 % adult, 3 % paediatric) in both populations.
Maltese: Il-prevalenza ta' dan il-fenotip ta' metabolizzatur dgħajjef seta' jitqabbel mal-individwi adulti (6%) u dawk pedjatriċi minn sentejn sa 11-il sena (6%), u ogħla fis-Suwed (18% adulti, 16% pedjatriċi) milli fil-Kawkasi (2% adulti, 3% pedjatriċi) fiż-żewġ popolazzjonijiet.
English: In clinical trials in a paediatric population, the desloratadine syrup formulation was administered to a total of 246 children aged 6 months through 11 years.
Maltese: Fi provi kliniċi fit-tfal, il-formulazzjoni ta' mistura ta' desloratadine ngħatat b'kollox lil 246 tifel u tifla ta' etajiet minn 6 xhur sa 11-il sena.
English: Similar pharmacokinetic parameters were observed in a multiple-dose pharmacokinetic study conducted with the syrup formulation in paediatric poor metaboliser subjects 2- to 11-year old diagnosed with allergic rhinitis.
Maltese: Ġew osservati parametri farmakokinetiċi simili fi studju farmakokinetiku b'ħafna dożi li sar bilformulazzjoni tal-mistura f'individwi pedjatriċi li huma metabolizzaturi dgħajfin minn sentejn sa 11-il sena li kienu ddijanjostikati b'rinite allerġika.
English: Contains lactose.
Maltese: TA' EĊĊIPJENTI Fih lactose.
English: Approximately 6 % of adults and children 2- to 11-year old are phenotypic poor metabolisers of desloratadine and exhibit a higher exposure (see section 5.2).
Maltese: Madwar 6% tal-adulti u tfal ta' etajiet bejn sentejn u 11-il sena huma metabolizzaturi dgħajfin ta' desloratadine b'mod fenotipiku u juru esponiment ogħla (ara sezzjoni 5.2).
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu/
English: The presence of food prolongs Tmax for desloratadine from 2.5 to 4 hours and Tmax for 3-OHdesloratadine from 4 to 6 hours.
Maltese: Fil-preżenza tal-ikel it-Tmax ta' desloratadine jitwal minn 2.5 għal 4 sigħat, u t-Tmax għal 3-OH-desloratadine minn 4 għal 6 sigħat.
English: The efficacy of Aerius tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Maltese: L-effikaċja tal-pilloli Aerius ma ntwerietx b'mod ċar fi provi b'pazjenti adolexxenti minn 12 sa 17-il sena.
English: Tablet coating: film coat (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.
Maltese: Kisja tar-rita : (li fiha lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), kisja trasparenti (li fiha hypromellose, macrogol 400), carnauba wax,
English: Tablet coating contains film coat (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.
Maltese: Il-kisja tal-pillola għandha kisja b'rita (li fiha lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), kisja trasparenti (li fiha hypromellose, macrogol 400), carnauba wax, white wax.
English: There is no evidence of clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to 20 mg) for 14 days.
Maltese: M'hemmx evidenza ta' akkumulazzjoni rilevanti b'mod kliniku tal-mediċina wara li jingħata dożaġġ ta' desloratadine darba kuljum (5 mg sa 20 mg) għal 14-il ġurnata.
English: Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
Maltese: Uġigħ addominali, dardir, rimettar, dispepsija, dijarea
English: Aerius tablets effectively controlled symptoms for 24 hours.
Maltese: Il-pilloli Aerius ikkontrollaw is-sintomi b'mod effettiv għal 24 siegħa.
English: - The active substance is desloratadine 2.5 mg - The other ingredients are microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame (E951) and flavour Tutti-Frutti.
Maltese: - Is-sustanza attiva hi desloratadine 2.5 mg - Is-sustanzi l-oħra huma microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame (E951) u togħma ta' Tutti-Frutti.
English: At the recommended dose, Aerius 5 mg orodispersible tablet was found to be bioequivalent to the Aerius 5 mg conventional tablet formulation of desloratadine.
Maltese: Bid-doża rakkomandata, il-pillola li tinħall fil-ħalq Aerius 5 mg instabet li hija bijoekwivalenti għallformulazzjoni tal-pillola konvenzjonali Aerius 5 mg ta' desloratadine.
English: Children, 1-11 years of age, who were candidates for antihistamine therapy received a daily desloratadine dose of 1.25 mg (1 through 5 years of age) or 2.5 mg (6 through 11 years of age).
Maltese: Tfal bejn sena u 11-il sena, li kienu kandidati għal terapija b'mediċini antiistaminiċi, irċivew doża ta' 1.25 mg (minn sena sa 5 snin) desloratadine kuljum jew 2.5 mg (minn 6 sa 11-il sena).
English: - The active substance is desloratadine 5 mg - The other ingredients are microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame (E951) and flavour Tutti-Frutti.
Maltese: - Is-sustanza attiva hi desloratadine 5 mg - Is-sustanzi l-oħra huma microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame (E951) u togħma ta' Tutti-Frutti.
English: The recommended dose is 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.
Maltese: Id-doża rakkomandata hija 2.5 ml (1/2 kuċċarina ta' 5 ml) tas-soluzzjoni orali darba kuljum.
English: Each ml of oral solution contains 0.5 mg desloratadine.
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni orali fih 0.5 mg desloratadine.
English: No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
Maltese: Ma ġewx osservati interazzjonijiet klinikament rilevanti waqt provi kliniċi li fihom il-pilloli desloratadine ngħataw flimkien ma' erythromycin jew ketoconazole (ara sezzjoni 5.1).
English: Aerius 5 mg orodispersible tablet is light red, speckled, and round with “A” branded on one side.
Maltese: Aerius 5 mg pillola li tinħall fil-ħalq hija ħamra ċara, ittikkjata, u tonda immarkata b'“A” fuq naħa.
English: Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria) Asthenia
Maltese: Reazzjonijiet ta' sensittività eċċessiva (bħal reazzjonijiet anafilattiċi, anġjoedema, ħakk, raxx u urtikarja)
English: EU/1/00/160/001 1 tablet EU/1/00/160/002 2 tablets EU/1/00/160/003 3 tablets EU/1/00/160/004 5 tablets EU/1/00/160/005 7 tablets EU/1/00/160/006 10 tablets EU/1/00/160/007 14 tablets EU/1/00/160/008 15 tablets EU/1/00/160/009 20 tablets EU/1/00/160/010 21 tablets EU/1/00/160/011 30 tablets EU/1/00/160/012 50 tablets EU/1/00/160/036 90 tablets EU/1/00/160/013 100 tablets
Maltese: EU/1/00/160/007 14-il pillola EU/1/00/160/008 15-il pillola EU/1/00/160/009 20 pillola EU/1/00/160/010 21 pillola EU/1/00/160/011 30 pillola EU/1/00/160/012 50 pillola EU/1/00/160/036 90 pillola EU/1/00/160/013 100 pillola
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1, jew għal loratadine.
English: sodium citrate dihydrate, natural and artificial flavour (bubblegum), citric acid anhydrous, disodium edetate, purified water
Maltese: sucralose E 955, hypromellose 2910, sodium citrate dihydrate, essenza naturali u artifiċjali (babbilgam), citric acid anhydrous, disodium edetate,
English: - The active substance is desloratadine 5 mg - The other ingredients of the tablet are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc.
Maltese: - Is-sustanza attiva hi desloratadine 5 mg - Is-sustanzi l-oħra tal-pillola huma calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc.
English: Aerius 5 mg tablet desloratadine
Maltese: Aerius pillola 5 mg desloratadine
English: 5 orodispersible tablets 6 orodispersible tablets 10 orodispersible tablets 12 orodispersible tablets 15 orodispersible tablets 18 orodispersible tablets 20 orodispersible tablets 30 orodispersible tablets 50 orodispersible tablets 60 orodispersible tablets 90 orodispersible tablets 100 orodispersible tablets
Maltese: 20 pillola li jinħallu fil-ħalq 30 pillola li jinħallu fil-ħalq 50 pillola li jinħallu fil-ħalq 60 pillola li jinħallu fil-ħalq 90 pillola li jinħallu fil-ħalq 100 pillola li jinħallu fil-ħalq
English: 30 ml with 1 spoon 50 ml with 1 spoon 60 ml with 1 spoon 100 ml with 1 spoon 120 ml with 1 spoon 150 ml with 1 spoon 150 ml with 1 oral syringe 225 ml with 1 spoon 300 ml with 1 spoon
Maltese: 30 ml b'kuċċarina waħda 50 ml b'kuċċarina waħda 60 ml b'kuċċarina waħda 100 ml b'kuċċarina waħda 120 ml b'kuċċarina waħda 150 ml b'kuċċarina waħda 150 ml b'siringa waħda għall-ħalq 225 ml b'kuċċarina waħda 300 ml b'kuċċarina waħda
English: There is limited clinical trial efficacy experience with the use of desloratadine in children 1 through 11 years of age and adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Maltese: Hemm esperjenza limitata dwar l-effikaċja minn provi kliniċi bl-użu ta' desloratadine fi tfal minn sena sa 11-il sena u f'adolexxenti minn 12 sa 17-il sena (ara sezzjonijiet 4.8 u 5.1).
English: In a clinical pharmacology trial, Aerius tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Maltese: Fi prova farmakoloġika klinika, pilloli Aerius li ttieħdu flimkien mal-alkoħol ma żidux l-effetti talalkoħol li jxekkel il-prestazzjoni (ara sezzjoni 5.1).
English: Based on a multiple dose clinical trial in adults and adolescents, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.
Maltese: Abbażi ta' prova klinika b'ħafna dożi f'adulti u adolexxenti, li fiha ngħataw sa 45 mg ta' desloratadine (disa' darbiet id-doża klinika), ma ġew osservati l-ebda effetti kliniċi rilevanti.
English: There is limited clinical trial efficacy experience with the use of desloratadine in children 6 through 11 years of age (see section 5.2).
Maltese: Hemm esperjenza limitata dwar l-effikaċja minn provi kliniċi bl-użu ta' desloratadine fi tfal minn 6 snin sa 11-il sena (ara sezzjoni 5.2).
English: This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Aerius orodispersible tablet.
Maltese: Dan il-prodott fih 1.4 mg phenylalanine għal kull doża ta' 2.5 mg ta' pillola li tinħall fil-ħalq Aerius.