FrancophonIA/ELRC3.0 huggingface dataset:
English: - 10 ml Zyrtec oral solution (=2 measuring spoons) contain: 3.15 g glucose equivalents (sorbitol).
Maltese: - 10 ml ta' Zyrtec soluzzjoni orali (= żewġ imgħaref ta' kejl) fih: ekwivalenti ta' 3.15 g ta' glucose (sorbitol).
English: Hungary: Zyrtec filmtabletta, Zyrtec start filmtabletta Ireland: Zirtek tablets
Maltese: Zyrtec filmtabletta, Zyrtec start filmtabletta L-Irlanda:
English: Boxes of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, or 100 tablets.
Maltese: Kaxxi ta' 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, jew 100 pillola.
English: Belgium UCB Pharma SA (Brussels) Allée de la Recherche, 60
Maltese: Il-Lussemburgu UCB Pharma SA (Brussels) Allée de la Recherche, 60
English: [To be completed nationally] {Name and address} {tel} {fax} {e-mail}
Maltese: [Biex timtela mill-pajjiż partikolari] [Isem u indirizz] {telefon} {fax} {e-mail}
English: Sweden: Alerid, Zyrlex
Maltese: Alerid, Zyrlex
English: UCB SA Pharma Secteur Chemin du Foriest, B-1420 Braine l´Alleud Belgium
Maltese: UCB Pharma SA (BRAINE) Chemin du Foriest Braine-l'Alleud B-1420 Il-Belġju
English: Braine-l'Alleud
Maltese: Braine l´Alleud Il-Belġju
English: Gastro-intestinal system disorders Diarrhoea
Maltese: Mard tas-sistema gastro-intestinali Dijareja
English: Uncommon: agitation
Maltese: Mhux komuni: aggressjoni
English: Ltd (CY) 8 Ayiou Nicolaou Street P.O.
Maltese: Lifepharma (Z.A.M.) Ltd (CY) 8 Ayiou Nicolaou Street P.O. Box 22679
English: - Respiratory system disorders: common: pharyngitis, rhinitis
Maltese: - Mard tas-sistema respiratorja: komuni: farinġite, rinite
English: Spain: Alerlisin, Virlix, Reactine 5mg/5ml solución oral, Zyrtec solución oral Sweden: Zyrlex
Maltese: Alerlisin, Virlix, Reactine 5mg/5ml solución oral, Zyrtec solución oral L-Isvezja:
English: In some cases, paradoxical CNS stimulation has been reported.
Maltese: F'xi każi, kien irrapportat stimulazzjoni paradossali tas-CNS.
English: Italy: Formistin, Virlix, Zirtec 10mg/ml gocce orali soluzione Latvia: Zyrtec
Maltese: Formistin, Virlix, Zirtec 10mg/ml gocce orali soluzione Il-Latvja:
English: Excipients: - one ml of solution contains 1.35 mg methylparahydroxybenzoate
Maltese: Is-sustanzi mhux attiva: - ml wieħed tas-soluzzjoni fiħ 1.35 mg methylparahydroxybenzoate
English: Whereas
Maltese: Iżda,
English: Dosage and frequency
Maltese: Dożaġġ u frekwenza
English: ZYRTEC 10 MG/ML PERORALNE KAPLJICE, RAZTOPINA
Maltese: Zyrtec10 mg/ml peroralne kapljice, raztopina Spanja:
English: ZYRTEC GOTAS ORALES EN SOLUCIÓN
Maltese: ZYRTEC GOTAS ORALES EN
English: Italy: Formistin, Virlix, Zirtec 10 mg compresse rivestite con film Latvia: Zyrtec
Maltese: Formistin, Virlix, Zirtec 10 mg compresse rivestite con film Il-Latvja:
English: Pack with a bottle of 10, 15, 20, or 30 ml solution.
Maltese: Pakkett oriġinali b'flixkun ta' 10, 15, 20, jew 30 ml ta' soluzzjoni.
English: Content (concentration)
Maltese: Il-Kontenut (Konċentrat)
English: Oral solution Bottle of 60 ml Bottle of 75 ml Bottle of 100 ml Bottle of 125 ml Bottle of 150 ml Bottle of 200 ml
Maltese: Taqtir tal-ħalq, soluzzjoni Flixkun ta' 60 ml Flixkun ta' 75 ml Flixkun ta' 100 ml Flixkun ta' 125 ml Flixkun ta' 150 ml Flixkun ta' 200 ml
English: 90 tablets
Maltese: 90 pilloli
English: France: Reactine, Virlix, Cetirizine UCB 10mg, Zyrtec, Actifed Allergie cetirizine 10mg, Zyrtecset Germany: Zyrtec, Zyrtec P, Reactine
Maltese: Reactine, Virlix, Cetirizine UCB 10mg, Zyrtec, Actifed Allergie cetirizine 10mg, Zyrtecset Il-Ġermanja:
English: Cetirizine exhibits linear kinetics over the range of 5 to 60 mg.
Maltese: Cetirizine għandu kinetika linejari fuq medda bejn 5 sa 60 mg.
English: Exp:
Maltese: Lott:
English: Adverse drug reactions (WHO-ART)
Maltese: Effett Mhux Mixtieq (WHO-ART)
English: 21 tablets
Maltese: 21 pilloli
English: Poland: Reactine, Virlix, Zyrtec, Zyrtec UCB
Maltese: Il-Polonja: Reactine, Virlix, Zyrtec, Zyrtec UCB
English: 20 tablets
Maltese: 20 pilloli
English: Respiratory system disorders Rhinitis
Maltese: Mard tas-sistema respiratorja Rinite
English: Clinical trials
Maltese: Provi Kliniċi
English: Pfizer Consumer Healthcare BV Rivium Westlaan 142
Maltese: Pfizer Consumer Healthcare BV Rivium
English: Zyrtec (cetirizine dihydrochloride) is an antiallergic drug indicated for the relief of nasal symptoms of seasonal and perennial allergic rhinitis.
Maltese: Zyrtec (cetirizine dihydrochloride) huwa mediċina antiallerġenika indikata għas-serħan mis-sintomi nażali tar-rinite allerġika staġjonali u perennali.
English: Amber glass bottle (type III) of 60, 75, 100, 125, 150, or 200 ml, closed with a white polypropylene child-resistant closure.
Maltese: Flixkun tal-ħġieġ ta' kulur ambra (tat-tip III ) ta' 60, 75, 100, 125, 150 jew 200 ml, magħluq b'tapp li ma jinfetaħx mit-tfal tal-polyethylene abjad.
English: The MAH was also asked to justify the dosing in paediatric patients suffering from renal impairment and the dosing by weight in the 2-5 year age group and dosing by age groups 2-5, 6-11 and 12-18 as well as dosing for children less than 2 years old.
Maltese: Il-MAH intalab ukoll jiġġustifika d-doża f'pazjenti pedjatriċi li jsofru minn insuffiċjenza renali u d-doża skond il-piż filgruppi ta' età ta' bejn sentejn u 5 snin, u d-doża fil-gruppi ta' età ta' bejn sentejn u 5 snin, 6 u 11-il sena u 12 u 18-il sena kif ukoll id-dożi għal tfal ta' inqas minn sentejn.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 1 mg cetirizine dihydrochloride Excipients: - one ml of solution contains 450 mg sorbitol (solution at 70 %, non crystallizing) - one ml of solution contains 1.35 mg methylparahydroxybenzoate - one ml of solution contains 0.15 mg propylparahydroxybenzoate For a full list of excipients, see section 6.1
Maltese: - ml wieħed ta'soluzzjoni fiħ 450 mg sorbitol (soluzzjoni ta' 70 % (li ma tikkristillax) - ml wieħed ta'soluzzjoni fiħ 1.35 mg methylparahydroxybenzoate - ml wieħed ta'soluzzjoni fiħ 0.15 mg propylparahydroxybenzoate
English: Contains methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), sorbitol (E 420), among other substances.
Maltese: Fih methylparahydroxybenzoate (E 218) u propylparahydroxybenzoate (E 216), sorbitol (E 420), fost sustanzi oħra.
English: Uncommon: paraesthesia
Maltese: Mhux komuni: paresteżija
English: Pack with a bottle of 60, 75, 100, 125, 150, or 200 mL solution.
Maltese: Pakkett oriġinali b'flixkun ta' 60, 75,100, 125, 150, jew 200 mL ta' soluzzjoni.
English: Slovenia: Zyrtec1 mg/ml peroralna raztopina
Maltese: Zyrtec1 mg/ml peroralna raztopina
English: • Adults and adolescents over 12 years of age: 10 mg once daily (20 drops).
Maltese: • Adulti u adolexxenti ta' iktar minn 12-il sena: 10 mg darba kuljum (20 qatra).
English: The apparent volume of distribution is 0.50 l/kg.
Maltese: Milli jidher, il-volum ta' distribuzzjoni huwa ta' 0.50 l/kg.
English: Patients with rare hereditary problems of fructose intolerance should not take cetirizine 1 mg/ml oral solution.
Maltese: Pazjenti bi problem ereditarji rari ta' intolleranza għal fructose m'għandhomx jieħdu cetirizine 1 mg/ml soluzzjoni orali.
English: Psychiatric disorders:
Maltese: Mard psikjatriku:
English: Hepatobiliary disorders: Rare: hepatic function abnormal (increased transaminases, alkaline phosphatase, γ-GT and bilirubin)
Maltese: Rari: funzjoni tal-fwied abnormali (żieda fit-transaminases, alkaline phosphatase, γ-GT u bilirubin)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ALUMINIUM BLISTERS
Maltese: Folji tal-aluminju/PVC
English: 100 tablets
Maltese: 100 pilloli
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take cetirizine film-coated tablet.
Maltese: - Jekk għandek problemi ereditarji ta' intolleranza għal galactose, id-defiċjenza Lapp lactase jew mal-assorbiment ta' glucose-galactose.
English: Slovenia: Zyrtec10 mg filmsko oblozene tablete
Maltese: Zyrtec10 mg filmsko oblozene tablete
English: - Hepatobiliary disorders: rare: liver function abnormal
Maltese: - Mard tal-fwied u tal-marrara: rari: funzjoni tal-fwied abnormali
English: 60 tablets
Maltese: 60 pilloli
English: - Renal and urinary disorders: very rare: abnormal elimination of urine
Maltese: - Mard tal-kliewi u tas-sistema urinarja: rari ħafna: eliminazzjoni abnormali tal-awrina
English: Contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), among other substances.
Maltese: Fih methylparahydroxybenzoate (E 218) u propylparahydroxybenzoate (E 216), fost sustanzi oħra.
English: 4 tablets
Maltese: 4 pilloli
English: Poland: Zyrtec
Maltese: Il-Polonja: Zyrtec
English: Poland: Virlix, Zyrtec
Maltese: Il-Polonja: Virlix, Zyrtec
English: Belgium: Reactine, Cetirizine-UCB, Zyrtec
Maltese: Reactine, Cetirizine-UCB, Zyrtec
English: 50 tablets
Maltese: 50 pilloli
English: 14 tablets
Maltese: 14 pilloli
English: UCB GmbH Huttenstraße 205 D-50170 Kerpen Germany
Maltese: UCB GmbH Huttenstraße 205
English: The frequencies are defined as such: (common: 1 patient out of 100 to 1 out of 10, uncommon: 1 out of 1,000 to 1 out of 100, rare: 1 out of 10,000 to 1 out of 1,000, very rare: less than 1 out of 10,000).
Maltese: Il-frekwenzi huma definiti hekk: ( komuni: pazjent 1 minn kull 100 sa I minn kull 10, mhux komuni: 1 minn kull 1,000 sa 1 minn kull 100, rari: 1 minn kull 10,000 sa 1 minn kull 1,000, rari ħafna għal < 1/100, rari:
English: - Psychiatric disorders: common: somnolence uncommon: agitation rare: aggression, confusion, depression, hallucination, insomnia very rare: tic
Maltese: - Mard psikjatriku: komuni: ngħas tqil mhux komuni: aġitazzjoni rari: aggressjoni, konfużjoni, depressjoni, alluċinazzjonijiet, insomnija, rari ħafna: tikk
English: Regarding the dosing by age group, the MAH defended the same dosing for age group 12 to 18 as in adults because the increase in body weight is compensated by a decrease in clearance, allowing for an equivalent systemic exposure.
Maltese: Dwar id-dożi skond il-grupp ta' età, il-MAH iddefenda l-istess doża għall-grupp ta' età ta' bejn 12 u 18-il sena kif ukoll fladulti, għax iż-żieda fil-piż tal-ġisem hija kkumpensata minn tnaqqis fir-rata ta' eliminazzjoni, u dan jippermetti espożizzjoni sistemika ekwivalenti.
English: 45 tablets
Maltese: 45 pilloli
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml solution contain 1 mg of cetirizine dihydrochloride
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA 1 ml tas-soluzzjoni fih 1 mg ta' cetirizine dihydrochloride
English: The extent of bioavailability is similar when cetirizine is given as solutions, capsules or tablets.
Maltese: Il-biodisponibilta` totali hija simili meta cetirizine jingħata bħala soluzzjoni, kapsuli jew pilloli.
English: You should not take Zyrtec 1 mg/ml oral solution: - if you have rare hereditary problems of fructose intolerance
Maltese: M'għandekx tieħu Zyrtec 1 mg/ml soluzzjoni orali: - jekk inti għandek problema ereditarja rari ta' intolleranza għal fructose
English: The MAH also reworded the entire section 4.8 Undesirable effects in accordance with current guidelines and with the QRD comments received.
Maltese: Il-MAH bidel ukoll kompletament il-formolazzjoni tas-sezzjoni 4.8 Effetti mhux mixtieqa b'mod konformi mal-linji gwida attwali u mal-kummenti fil-QRD rċevuti.
English: 30 tablets
Maltese: 30 pilloli
English: - The other ingredients are microcrystalline cellulose, lactose, macrogol 400, magnesium stearate, hypromellose, colloidal silicon dioxide, titanium dioxide (E 171).
Maltese: hypromellose, colloidal silicon dioxide, titanium dioxide (E 171).
English: Children, infants and toddlers: The half-life of cetirizine was about 6 hours in children of 6-12 years and 5 hours in children 2-6 years.
Maltese: Tfal, Tfal żgħar u trabi: il-half-life ta' cetirizine kien ta' madwar 6 sigħat fi tfal ta' bejn is-6-12 il-sena u 5 sigħat f'tfal ta' bejn 2-6 snin.
English: 15 tablets
Maltese: 15 pilloli
English: Adverse drug reactions at rates of 1 % or greater in children aged from 6 months to 12 years, included in placebo-controlled clinical or pharmacoclinical trials are:
Maltese: Ir-reazzjonijiet mhux mixtieqa għal mediċina fit-tfal t'eta` ta' bejn 6 xhur u 12-il xahar, f'rati ta' 1 % jew aktar, inklużi fi provi kliniċi u farmakokliniċi kkontrollati double-blind huma:
English: Amber glass bottle (type III) with 10, 15, 20, or 30 ml solution, fitted with a dropper insert in white low density polyethylene and closed with a white polypropylene child-resistant closure.
Maltese: Flixkun tal-ħġieġ ta' kulur ambra (tat-tip III ) b' 10, 15, 20, jew 30 ml ta' soluzzjoni, mgħammar b' qattara mdaħħla ta' polyethylene ta' densita` baxxa abjad u magħluq b'tapp li ma jistax jinfetaħ mittfal tal-polyethylene abjad.
English: Rare: hypersensitivity Very rare: anaphylactic shock
Maltese: Rari: sensittivita` eċċessiva
English: Luxemburg
Maltese: HELSINKI
English: Pharmacotherapeutic group: Piperazine derivatives, ATC code: R06A E07
Maltese: Kategorija farmakoterapewtika: derivattivi ta' piperazine, Kodiċi ATC:
English: Renally impaired patients: The pharmacokinetics of the drug were similar in patients with mild impairment (creatinine clearance higher than 40 ml/min) and healthy volunteers.
Maltese: Il-farmakokinetika tal-mediċina kienet simili f'pazjenti b'indeboliment ħafif (clearance tal-krejatinina iżjed minn 40 ml/min) u voluntiera normali.
English: 40 tablets
Maltese: 40 pilloli
English: Adults and adolescents above 12 years old:
Maltese: Adulti u addoloxxenti ‘l fuq minn 12-il sena:
English: The distribution of pharmacokinetic parameters such as peak plasma concentration (Cmax) and area under curve (AUC), is unimodal in human volunteers.
Maltese: Id-distribuzzjoni ta' parametri farmakokinetiċi, bħall-ogħla konċentrazzjoni fil-plażma (Cmax) u l-erja taħt il-kurva (AUC), kienu unimodal f'voluntiera umani.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablets contains 10 mg cetirizine dihydrochloride Excipients: one film-coated tablet contains 66.40 mg lactose-monohydrate For a full list of excipients, see section 6.1
Maltese: U KWANTITATTIVA Pillola waħda miksija b'rita fiha 10 mg cetirizine dihydrochloride Sustanzi mhux attivi: pillola miksija b'rita waħda fiha 66.40 mg lactose monohydrate.
English: - Sorbitol solution at 70 % (non crystallizing) (E420) - Glycerol - Propylene glycol - Sodium saccharinate - Methylparahydroxybenzoate (E 218) - Propylparahydroxybenzoate (E 216) - Banana flavor 54.330/A (Firmenich) - Sodium acetate - Glacial acetic acid - Purified water
Maltese: - soluzzjoni ta'sorbitol ta' 70 % (li ma tikkristillax) - Glycerol - Propylene glycol - Sodium saccharinate - Methylparahydroxybenzoate - Propylparahydroxybenzoate - Togħma ta' banana 54.330/A (Firmenich) - Sodium acetate - Glacial acetic acid - Ilma purifikat
English: 5 tablets
Maltese: 5 pilloli
English: McNeil Sweden AB,
Maltese: McNeil Sweden AB, Sollentuna L-Isvezja
English: - Glycerol - Propylene glycol - Sodium saccharinate - Methylparahydroxybenzoate (E 218) - Propylparahydroxybenzoate (E 216) - Sodium acetate - Glacial acetic acid - Purified water
Maltese: - Glycerol - Propylene glycol - Sodium saccharinate - Methylparahydroxybenzoate - Propylparahydroxybenzoate - Sodium acetate - Glacial acetic acid - Ilma purifikat
English: Rare: aggression, confusion, depression, hallucination, insomnia Very rare: tic
Maltese: Rari: aggressjoni, konfużjoni, depressjoni, alluċinazzjonijiet, insomnija, Rari ħafna: tikk
English: - The other ingredients are glycerol, propylène glycol, saccharine sodium, methyl (4hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, sodium acetate, acetic acid, purified water.
Maltese: - Is-sustanzi l-oħra huma glycerol, propylène glycol, saccharine sodium, methyl (4hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, sodium acetate, acetic acid, ilma purifikat.
English: Zyrtec 1 mg/mlorale Lösung oral solution
Maltese: Zyrtec 1 mg/mlorale Lösung
English: {tel} {fax} {e-mail}
Maltese: Sewqan u tħaddim ta' magni:
English: Italy: Zirtec 1mg/ml soluzione orale
Maltese: Zirtec 1mg/ml soluzione orale
English: Slovak Republic: Zyrtec tbl flm 10mg
Maltese: ZYRTEC TBL FLM 10MG
English: - The other ingredients are sorbitol (E 420), glycerol, propylene glycol, saccharine sodium, methyl (4-hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, flavouring agent, sodium acetate, acetic acid, purified water.
Maltese: - Is-sustanzi l-oħra huma Sorbitol (E420), glycerol, propylène glycol, saccharine sodium, methyl (4-hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, sustanza għat-togħma, sodium acetate, acetic acid, ilma purifikat.
English: For these less frequently reported undesirable effects, the estimate d frequencies (uncommon: ≥1/1,000 to 1/100, rare: ≥1/10,000 to 1/1,000, very rare: 1/10,000) are made based on post-marketing experience.
Maltese: ≥1/10,000 għal < 1/1,000, rari ħafna: < 1/10,000) huma mfassla bbażati fuq rapporti ta' wara t-tqegħid fis-suq.
English: The doses proposed for registration have been demonstrated as being safe and effective in many trials performed in children 2 to 12 years old, as reviewed in the clinical expert report provided in the MAH dossier.
Maltese: Id-dożi proposti għar-reġistrazzjoni ntwerew li huma siguri u effettivi f'ħafna provi li saru fi tfal ta' bejn sentejn u 12il sena, kif riveduti fir-rapport kliniku ta' l-esperti pprovdut fid-dossier tal-MAH.
English: 5 mg once daily
Maltese: 5mg
English: When a treatment with cetirizine is stopped after repeated administration, the skin recovers its normal reactivity to histamine within 3 days.
Maltese: Meta trattament b'cetirizine kien mwaqqaf wara li ngħata ripetutament, il-ġilda ġiet lura għal reattivita` normali għal histamine li kella qabel fi żmien 3 ijiem.
English: Immune system disorders:
Maltese: Mard tas-sistema immuni:
English: The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:
Maltese: Il- CLcr (ml/min) tista' tiġi kalkulata mill-valur tal-krejatinina tas-serum(mg/dl) billi tintuża din il-formula:
English: Austria: Zyrtec 10 mg -Filmtabletten
Maltese: Zyrtec 10 mg - Filmtabletten
English: • Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis
Maltese: • Cetirizine huwa indikat għas-serħan mis-sintomi nażali u mis-sintomi okulari tar-rinite allerġika staġjonali u perennali
English: Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1receptors.
Maltese: Cetirizine, prodott tal-metaboliżmu ta' hydroxyzine fil-bniedem, huwa antagonist qawwi u selettiv ta' riċetturi periferali tip H1.
English: Portugal: Zyrtec, Virlix
Maltese: Zyrtec, Virlix
English: Luxembourg: Virlix, Zyrtec, Cetirizine-UCB Norway: Zyrtec
Maltese: Virlix, Zyrtec, Cetirizine-UCB In-Norveġja:
English: Norway: Reactine, Zyrtec
Maltese: Reactine, Zyrtec
English: Austria: Zyrtec 1 mg/ml - orale Lösung
Maltese: Zyrtec 1 mg/ml - orale Lösung
English: LIST OF EXCIPIENTS Also contains lactose.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Fih ukoll lactose.
English: Respiratory system disorders Pharyngitis
Maltese: Mard tas-sistema respiratorja Farinġite
English: In a placebo-controlled study, cetirizine given at the high daily dose of 60 mg for seven days did not cause statistically significant prolongation of QT interval.
Maltese: Fi studju kkontrollat mill-plaċebo, cetirizine, li ngħata f'doża għolja ta' 60 mg għal sebat ijiem, ma kkawżax titwil statistikament sinifikanti tal-interval QT.
English: Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.
Maltese: Ġew rapportati effetti mhux mixtieqa bħal konfużjoni, dijareja, sturdament, għeja, uġigħ ta' ras, tħossok ma tiflaħx, tkabbir tal-pupilla, ħakk, irrekwitezza, sedazzjoni, ngħas tqil, sturdament, il-qalb tħabbat aktar mis-soltu, rogħda, u ma tistax tgħaddi awrina.
English: Adults and adolescents over 12 years of age: 10 mg once daily (10 ml oral solution (2 full spoons)).
Maltese: Adulti u addoloxxenti ‘l fuq minn 12-il sena: 10 mg darba kuljum (10 ml soluzzjoni orali (2 imgħaref sħaħ)).
English: - Nervous system disorders: common: dizziness, headache uncommon: paresthesia (abnormal feelings of the skin), rare: convulsions, movements disorders very rare: syncope, tremor, dysgeusia (altered taste)
Maltese: - Mard tas-sistema nervuża: komuni: sturdament, uġigħ ta' ras mhux komuni: para-esteżija (sensazzjoni abnormali fil-ġilda) rari: aċċessjonijiet, mard tal-moviment, rari ħafna: sinkope,rogħda, disġewsja(tibdil fit-togħma)
English: ZYRTEC OLDAT 1mg/ml oral solution
Maltese: ZYRTEC OLDAT 1mg/ml
English: Ireland: Zirtek oral solution 1mg/ml
Maltese: Zirtek oral solution 1mg/ml
English: One ml of solution contains 10 mg of cetirizine dihydrochloride, one drop of solution contains 0.5 mg cetirizine dihydrochloride
Maltese: U KWANTITATTIVA Ml wieħed tas-soluzzjoni fiħ 10 mg cetirizine dihydrochloride, taqtira waħda tas-soluzzjoni fiha 0.5 mg cetirizine dihydrochloride.
English: Strength Pharmaceutical Form
Maltese: GĦAMLA FARMAĊEWTIKA
English: Luxembourg: Reactine, Zyrtec, Cetirizine-UCB
Maltese: Reactine, Zyrtec, Cetirizine-UCB Malta:
English: Patients on hemodialysis (creatinine clearance less than 7 ml/min) given a single oral 10 mg dose of cetirizine had a 3-fold increase in half-life and a 70 % decrease in clearance compared to normals.
Maltese: Pazjenti fuq l-emodijaliżi (clearance tal-krejatinina inqas minn 7 ml/min) li ngħataw doża waħda ta' 10 mg ta' cetirizine kellhom żieda ta' tliet darbiet aktar fil-half-life u tnaqqis ta' 70% fil-clearance meta mqabbla ma' voluntiera normali.
English: Zyrtec is an antiallergic medication.
Maltese: Zyrtec hija mediċina ta' kontra l-allerġiji.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of cetirizine dihydrochloride
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 10 mg ta' cetirizine dihydrochloride
English: The drug is authorised for the symptomatic treatment of seasonal allergic rhinitis, perennial allergic rhinitis, and various types of pruritus and dermatological conditions from allergic origin, in particular chronic idiopathic urticaria.
Maltese: Il-mediċina hija awtorizzata għat-trattament sintomatiku tar-rinite allerġika staġjonali, rinite allerġika perennali, u diversi tipi ta' ħakk u kundizzjonijiet dermatoloġiċi minn oriġini allerġika, b'mod partikolari urtikarja idjopatika kronika.
English: The CHMP acknowledged the problem of translating from old to new formats and the MAH's division of events into frequencies observed in clinical trials and frequencies estimated from post marketing experience could be agreed upon.
Maltese: Is-CHMP irrikonoxxa lproblema tal-qlib minn formati qodma għal dawk ġodda u seta' jintlaħaq ftehim fuq id-diviżjoni ta' episodji tal-MAH fi frekwenzi osservati fil-provi kliniċi u l-frekwenzi stmati mill-esperjenza ta' wara t-tqegħid fis-suq.
English: Special populations:
Maltese: Investigazzjonijiet:
English: Cardiac disorders: Rare: tachycardia
Maltese: Mard tal-qalb: Rari: takikardja
English: Cetirizine was poorly cleared by haemodialysis.
Maltese: Cetirizine ma jissaffiex effettivament bid-dijaliżi.
English: What Zyrtec contains - The active substance of Zyrtec is cetirizine dihydrochloride.
Maltese: - Is-sustanzi attiva ta' Zyrtec hija cetirizine dihydrochloride.
English: Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/day).
Maltese: farmakdinamiċi u lanqas interazzjonijiet farmakokinetiċi sinifikanti fi studji li saru dwar l-effetti ta' mediċini jew ta' affarijiet oħra fuq l-effett farmaċewtiku tal-prodott, speċjalment b'psewdo-efedrine jew theophylline (400 mg/ġurnata).
English: A harmonized wording for age groups and relevant posology was agreed upon:
Maltese: Intlaħaq qbil fuq formolazzjoni armonizzata tal-kliem għall-gruppi ta' età u l-pożoloġija relevanti: