qanastek/EMEA-V3 huggingface dataset:
The safe use of Aerinaze during pregnancy has not been established; however experience from a large number of exposed pregnancies in humans does not reveal any increase in the frequency of malformations as compared to the incidence in the general population.
L- użu sigur ta ’ Aerinaze waqt it- tqala ma ġiex stabbilit, iżda esperjenza minn numru kbir ta ’ esponimenti waqt it- tqala fil- bniedem ma tindikax xi żieda fl- ammont ta ’ malformazzjonijiet meta mqabbla ma ’ l- inċidenza fil- popolazzjoni ġenerali.
4 Because animal reproduction studies are not always predictive of human response, and due to the vasoconstrictive properties of pseudoephedrine, Aerinaze should not be used during pregnancy.
Minħabba li l- istudji dwar ir- riproduzzjoni fl- annimali mhux dejjem ikunu jistgħu jintużaw biex jitbassar ir- rispons fil- bniedem, u minħabba l- effetti ta ’ vażokostrizzjoni li għandu pseudoephedrine, Aerinaze m’ għandux jintuża waqt it- tqala.
Desloratadine and pseudoephedrine are both excreted in breast milk.
4 Desloratadine u pseudoephedrine jiġu eskretati t- tnejn fil- ħalib tas- sider.
Decreased milk production in nursing mothers has been reported with pseudoephedrine.
Tnaqqis fl- ammont ta ’ ħalib li joħrog minn ommijiet li jkunu qed ireddgħu kien irrappurtat bi pseudoephedrine.
Therefore Aerinaze should not be used in breast-feeding women.
Għalhekk Aerinaze m’ għandux jintuża f’ nisa li qed ireddgħu.
No studies on the effects on the ability to drive and use machines have been performed with Aerinaze.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni b’ Aerinaze.
In clinical trials that assessed the driving ability, no impairment occurred in patients receiving desloratadine.
Fi provi kliniċi li evalwaw il- ħila ta ’ sewqan, ma kienx hemm tixkil f’ pazjenti li kienu qed jirċievu desloratadine.
However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
Madankollu l- pazjenti għandhom ikunu avżati li rari ħafna xi nies kellhom ngħas, li jista ’ jeffettwa l - ħila tagħhom biex isuqu jew jużaw magni.
It is not expected that pseudoephedrine sulphate impairs psychomotor performance.
Mhux mistenni li pseudoephedrine sulphate ixekkel il- ħila psikomotriċi.
In clinical trials involving 414 adults the most frequent of adverse events reported were insomnia (8.9%), dry mouth (7.2%) and headache (3.1%).
Fi provi kliniċi li fihom ħadu sehem 414 adult, l- aktar każijiet avversi rrappurtati kienu nuqqas ta ’ rqad (8. 9%), ħalq xott (7. 2%) u uġigħ ta ’ ras (3. 1%).
These and other undesirable effects reported during the clinical trials are listed in the following table.
Dawn l- effetti mhux mixtieqa u oħrajn li kienu rrappurtati waqt il- provi kliniċi qegħdin elenkati fit- tabella li ġejja.
Adverse reactions reported during clinical trials for Aerinaze very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000)
Reazzjonijiet avversi rrappurtati waqt provi kliniċi għal Aerinaze komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100, < 1/ 10); mhux komuni (≥ 1/ 1000, < 1/ 100); rari (≥ 1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000)
Cardiac disorders Common:
Disturbi fil- qalb Komuni:
Tachycardia Palpitation, premature atrial contractions
Takikardija Palpitazzjoni, kontrazzjonijiet prematuri ta ’ l- atrija
Mouth dry, dizziness, psychomotor hyperactivity Hyperkinesia, flushing, hot flushes, confusion
Iperkinesja, issir ruxxan, fwarwar ta ’ sħana, konfużjoni
Blurred vision, dry eyes
Vista mċajpra, għajnejn xotti
Pharyngitis Rhinitis, sinusitis, epistaxis, nasal irritation, rhinorrhea, dry throat, hyposmia
Farinġite Rajnajtis, sinusite, epistassi, irritazzjoni fl - imnieħer, rajnorreja, grieżem xotti, iposomja
Anorexia, constipation Dyspepsia, nausea, abdominal pain, gastroenteritis, stool abnormal
Anoressija, stitkezza Dispepsja, tqalligħ, uġigħ addominali, gastro - enterite, ippurgar anormali
Dysuria, micturition disorder, altered micturition frequency
Disurja, disturbi biex tgħaddi l- awrina, bidla fil - frekwenza biex tgħaddi l- awrina
Pruritus
Ħakk
Thirst, glycosuria, hyperglycemia
Għatx, zokkor fl- awrina, zokkor għoli fid- demm
5 General disorders and administration site conditions Common:
Komuni:
Headache, fatigue Headache aggravated, rigors
Uġigħ ta ’ ras, għeja Uġigħ ta ’ ras jaggrava, tregħid
Increased hepatic enzymes
Żieda ta ’ enzimi epatiċi
Common:
5 Disturbi psikjatriċi Komuni:
Insomnia, somnolence, sleep disorder, nervousness Agitation, anxiety, irritability
Nuqqas ta ’ rqad, ngħas, disturbi fl- irqad, nervi Aġitazzjoni, ansjetà, irritabilità
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma elenkati skond is- serjetà ta ’ tagħhom.
Other adverse reactions reported very rarely for desloratadine during the post-marketing period are listed in Table 2.
Effetti avversi oħrajn irrappurtati rari ħafna għal desloratadine fil- perijodu ta ’ wara t- tqegħid fis- suq huma elenkati f’ Tabella 2.
Adverse reactions reported during the post-marketing period for desloratadine
Effetti avversi irrappurtati għal desloratadine fil- perijodu ta ’ wara t- tqegħid fis- suq
Psychiatric disorders Nervous system disorders
Disturbi psikjatriċi Disturbi fis- sistema nervuża
Hallucinations Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Alluċinazzjonijiet Sturdament, ngħas, nuqqas ta ’ rqad, attività psikomotriċi eċċessiva, aċċessjonijiet
Cardiac disorders Gastrointestinal disorders
Disturbi fil- qalb Disturbi gastro- intestinali
Tachycardia, palpitations Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
Takikardija, palpitazzjonijiet Uġigħ addominali, tqalligħ, rimettar, dispepsja, dijarea
Elevations of liver enzymes, increased bilirubin, hepatitis
Żieda fl- enzimi tal- fwied, żieda fil- bilirubin, epatite
Musculoskeletal and connective tissue disorders General disorders
Disturbi muskolu- skeltrali u tal- connective tissue Disturbi ġenerali
Myalgia Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Mijalġja Reazzjonijiet ta ’ sensittività eċċessiva (bħal anafilassi, anġjo- edema, dispneja, ħakk, raxx u urtikarja)
Symptoms of overdose are mostly of a sympathomimetic nature.
Sintomi ta ’ doża eċċessiva huma fil- parti l- kbira ta ’ natura simaptomimetika.
Symptoms may vary from CNS depression (sedation, apnoea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) to CNS stimulation (insomnia, hallucination, tremors, convulsions) with possible fatal outcome.
Sintomi jvarjaw minn depressjoni tas- CNS (tħeddil, apneja, tnaqqis fil- viġilanza, ċijanożi, koma, kollass kardjoavaskulari) għal stimulazzjoni tas- CNS (nuqqas ta ’ rqad, alluċinazzjoni, tregħid, aċċessjonijiet) li jistgħu jkunu fatali.
Other symptoms may include: headache, anxiety, micturition difficulty, muscle weakness and tenseness, euphoria, excitement, respiratory failure, cardiac arrhythmias, tachycardia, palpitations, thirst, perspiration, nausea, vomiting, precordial pain, dizziness, tinnitus, ataxia, blurred vision and hypertension or hypotension.
Sintomi oħrajn jistgħu jinkludu: uġigħ ta ’ ras, ansjetà, diffikulta biex tgħaddi l - awrina, dgħjufija u tensjoni tal- muskoli, ewforja, eċitament, insuffiċjenza respiratorja, arritmiji kardijaċi, takikardija, palpitazzjonijiet, għatx, għaraq, tqalligħ, rimettar, uġigħ prekordjali, sturdament, żarżir fil- widnejn, atassja, vista mċajpra u pressjoni għolja jew pressjoni baxxa.
CNS stimulation is particularly likely in children, as are atropine-like symptoms (dry mouth, fixed and dilated pupils, flushing, hyperthermia, and gastrointestinal symptoms).
Stimulazzjoni tas - CNS x’ aktarx li sseħħ fit- tfal, bħal m’ huma sintomi li jixbhu l- atropine (ħalq xott, ħabba ta ’ l- għajn fissa u dilatata, isiru ruxxana, il- ġisem jisħon, u sintomi gastro- intestinali).
Some patients may present a toxic psychosis with delusions and hallucinations.
Xi pazjenti jista ’ jkollhom psikożi tossiċi b’ delużjonijiet u alluċinazzjonijiet.
In the event of overdose, start symptomatic and supportive treatment immediately and maintain it for as long as necessary.
F’ każ ta ’ doża eċċessiva, ibda mill- ewwel kura sintomatika u ta ’ support immedjata u żommha għal kemm ikun hemm bżonn.
Adsorption of active substance remaining in the stomach may be attempted by administration of active charcoal suspended in water.
Jista ’ jkun hemm tentattiv ta ’ adsorbiment tas- sustanza attiva permezz ta ’ għoti b’ faħam attivat sospiż fl- ilma.
Perform gastric lavage with physiologic saline solution, particularly in children.
Għamel lavanda gastrika b’ ilma bil- melħ fisżjoloġiku, l- aktar fit- tfal.
In adults, tap water can be used.
Fl- adulti jista ’ jintuża ilma tal- vit.
Remove as much as possible of the amount administered before the next instillation.
Neħħi kemm jista ’ jkun mill- ammont mogħti qabel it- tfigħ li jmiss.
Desloratadine is not removed by haemodialysis and it is not known if it is eliminated by peritoneal dialysis.
Desloratadine ma jitneħhiex bl- emodijalisi u mhux magħruf jekk jitneħhiex b’ dijalisi tal - peritonew.
After emergency treatment, continue to monitor the patient medically.
Wara kura ta ’ emerġenza, kompli l- monitoraġġ kliniku tal- pazjent.
Treatment of the pseudoephedrine overdose is symptomatic and supportive.
Kura ta ’ doża eċċessiva ta ’ pseudoephedrine hija sintomatika u b ’ support.
Stimulants (analeptics) must not be used.
Stimulanti (analettiċi) m’ għandhomx jintużaw.
Hypertension can be controlled with an adrenoceptor-blocking agent and tachycardia with a
Pressjoni għolja tista ’ tiġi kkontrollata b’ aġent li jimblokka l- adrenoċettur u takikardija b’ beta blocking agent.
Short acting barbituates, diazepam or paraldehyde may be administered to control seizures.
Barbiturati li jaħdmu fil- qosor, diazepam jew paraldehyde jistgħu jingħataw biex jikkontrollaw l- aċċessjonijiet.
Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or hypothermia blanket.
Temperatura għolja żżejjed, l- aktar fit- tfal, tista ’ teħtieġ kura b’ ilma fietel u sponza tal- banju jew liżar ipotermiku.
Apnoea is treated with respiratory assistance.
L- apneja hija kkurata b’ assistenza respiratorja.
Antihistamines – H1 antagonist, ATC code:
Anti- histaminiċi – antagonisti H1, Kodiċi ATC:
Pharmacotherapeutic group:
6 Kategorija farmakoterapewtika:
Nasal decongestants for systemic use group, ATC code:
Dikonġestjonanti għall- imnieħer għal użu tal- grupp sistemiku grupp, Kodiċi ATC:
The pharmacodynamics of Aerinaze tablets are directly related to that of its components.
Il- farmakodinamika tal- pilloli Aerinaze hija relatata direttament mil- komponenti tagħha.
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity.
Desloratadine huwa antagonist ta ’ l- histamina li jaħdem fit- tul u li ma jħeddilx b’ attività seletiva antagonista għar- riċettur H1.
After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system.
Wara li jingħata orali, desloratadine jimblokka b’ mod silettiv ir- riċetturi - H1 periferali minħabba li s- sustanza ma titħalliex tidħol fis- sistema nervuża ċentrali.
Desloratadine has demonstrated antiallergic properties from in vitro studies.
Desloratadine wera karatteristiċi kontra l- allerġiji minn studji in vitro.
These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/ basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells.
Dawn kienu jinkludu l - inibizzjoni tal- liberazzjoni ta ’ ċitokini li jikkawżaw l- infjammazzjoni bħal IL- 4, IL- 6, IL- 8 u IL- 13 miċ- ċelluli mast/ bażofiliċi, kif ukoll l- inibzzjoni ta ’ l- espressjoni tal- molekula ta ’ adeżjoni P- selectin fuq iċ- ċelluli endotiljali.
Desloratadine does not readily penetrate the central nervous system.
Desloratadine ma jippenetrax faċilment is- sistema nervuża ċentrali.
In a single dose study performed in adults, desloratadine 5 mg did not affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks related to flying.
Fi studju b’ doża waħda li sar fl - adulti, desloratadine 5 mg ma effettwax il- miżuri standard tal- ħila tat- titjir inkluża l- aggravar ta ’ ngħas individwali jew ħiliet relatati mat- titjir.
In controlled clinical trials, at the recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to placebo.
Fi provi kliniċi kontrollati, bid- doża rakkomandata ta ’ 5 mg kuljum, ma kienx hemm aktar każijiet ta ’ ngħas meta mqabbel mal- plaċebo.
Desloratadine given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Desloratadine mogħti b’ doża waħda ta ’ 7. 5 mg ma effettwax il- ħila psikomotriċi fil- provi kliniċi.
Pseudoephedrine sulphate (d-isoephedrine sulphate) is a sympathomimetic agent with mostly α -mimetic activity in comparison with the β -activity.
Pseudoephedrine sulphate (d- isoephedrine sulphate) huwa aġent simpatomimetiku b’ attività fil- parti l - kbira α- mimetika meta mqabbla ma ’ l- attività- β.
Pseudoephedrine sulphate provides a nasal decongestant effect after oral administration due to its vasoconstrictive action.
Pseudoephedrine sulphate jipprovdi effett dikonġestjonant wara li jittieħed orali minħabba l- effett vażokostrittiv tiegħu.
It has an indirect sympathomimetic effect due primarily to the release of adrenergic mediators from the post-ganglionic nerve endings.
Għandu effett simpatomimetiku indirett l- aktar minħabba li jikkawża l- ħelsien ta ’ medjaturi adrinerġiċi mit- truf tan - nervituri wara l- ganglija.
Oral administration of pseudoephedrine at the recommended dose can cause other sympathomimetic effects, such as increased blood pressure, tachycardia or manifestations of central nervous system excitation.
Meta pseudoephedrine jittieħed orali bid- doża rakkomandata jista ’ jikkawża effetti simpatomimetiċi oħrajn, bħal żieda fil- pressjoni tad- demm, takikardija, jew sinjali ta ’ eċitazzjoni tas- sistema nervuża ċentrali.
The clinical efficacy and safety of Aerinaze tablets was evaluated in two, 2-week multicentre, randomized parallel group clinical trials involving 1,248 patients 12 to 78 years of age with seasonal allergic rhinitis, 414 of whom received Aerinaze tablets.
L- effikaċja u s- sigurtà klinika tal- pilloli Aerinaze kienet evalwata f’ żewġ provi kliniċi ta ’ grupp parallel randomized multicenter ta ’ ġimgħatejn, li fih ħadu sehem 1, 248 pazjent minn 12 sa 78 sena b’ rajnajtis allerġiku ta ’ l- istaġun, li 414 minnhom irċevew pilloli Aerinaze.
In both trials, the antihistaminic efficacy of Aerinaze tablets as measured by total symptom score, excluding nasal congestion, was significantly greater than pseudoephedrine alone over the 2-week treatment period.
Fiż- żewġ provi, l- effikaċja anti- histaminika tal- pilloli Aerinaze meta tkejlet bil- punteġġ globali tas- sintomi, eskluż l- imblukkar ta ’ l- imnieħer, kienet akbar b’ mod sinifikanti milli bi pseudoephedrine waħdu fuq perijodu ta ’ kura li dam ġimgħatejn.
In addition, the decongestant efficacy of Aerinaze tablets, as measured by nasal stuffiness/ congestion, was significantly greater than desloratadine alone over the 2-week treatment period.
Minbarra hekk l- attività dikonġestjonanti tal- pilloli Aerinaze, hekk kif imkejla mill - imblukkar/ sadda ta ’ l- imnieħer, kienet akbar b’ mod sinifikanti milli b’ desloratadine waħdu fuq perijodu ta ’ kura li dam ġimgħatejn.
There were no significant differences in the efficacy of Aerinaze tablets across subgroups of patients defined by gender, age, or race.
Ma kienx hemm differenzi sinifikanti fl- effikaċja tal- pilloli Aerinaze fis- sottogruppi ta ’ pazjenti imqassma skond is- sess, età jew razza.
Desloratadine and Pseudoephedrine:
Desloratadine u pseudoephedrine:
7 In a single dose pharmacokinetic study with Aerinaze, plasma concentration of desloratadine can be detected within 30 minutes of administration.
Fi studju farmakokinetiku b’ doża waħda b’ Aerinaze, il- konċentrazzjoni fil- plażma ta ’ desloratadine tista ’ titkejjel fi żmien 30 minuta minn mea jingħata.
The mean time to maximum plasma concentrations (Tmax) for desloratadine occurred at approximately 4-5 hours post dose and mean peak plasma concentrations (Cmax) and area under the concentration-time curve (AUC) of approximately 1.09 ng/ ml and 31.6 ng• hr/ ml, respectively, were observed.
Il- medja tal- ħin biex intlaħqu l- ogħla konċentrazzjonijiet fil- plażma (Tmax) għal desloratadine seħħ wara madwar 4- 5 sigħat wara li ngħatat id- doża u deher li l- ogħla konċentrazzjonijiet fil- plażma (Cmax) u l- erja taħt il- kurva tal - konċentrazzjoni- ħin (AUC) kienu madwar 1. 09 ng/ ml u 31. 6 ng• hr/ ml rispettivament, kienu osservati.
For pseudoephedrine, the mean Tmax occurred at 6-7 hours post dose and mean peak plasma concentrations (Cmax and AUC) of approximately 263 ng/ ml and 4,588 ng• hr/ ml, respectively, were observed.
Għal pseudoephedrine, il- medja ta ’ Tmax seħħet wara 6- 7 sigħat wara li ngħatat id- doża u deher li l - medja ta ’ l- ogħla konċentrazzjonijiet fil- plażma (Cmax u AUC) kienu 263 ng/ ml u 4, 588 ng• hr/ ml, rispettivament, kienu osservati.
Food had no effect on the bioavailability (Cmax and AUC) of desloratadine or pseudoephedrine.
L- ikel ma kellu l- ebda effett fuq il- bijodisponibilità (Cmax u AUC) ta ’ desloratadine jew pseudophedrine.
The half-life for desloratadine is 27.4 hours.
Il- half- life ta ’ desloratadine hija 27. 4 sigħat.
The apparent half-life of pseudoephedrine is 7.9 hours.
Il- half- life apparenti ta ’ pseudoephedrine hija 7. 9 sigħat.
Following oral administration of Aerinaze for 14 days in normal healthy volunteers, steady-state conditions were reached on day 10 for desloratadine, 3-hydroxydesloratadine and pseudoephedrine.
7 Wara li Aerinaze ittieħed orali għal 14- il jum f’ voluntiera normali b’ saħħithom, kondizzjonijiet ta ’ stat fiss intlaħqu f’ jum 10 għal desloratadine, 3- hydroxydesloratadine u pseudoephedrine.
For desloratadine, mean steady state peak plasma concentrations (Cmax and AUC (0-12 h)) of approximately 1.7 ng/ ml and 16 ng• hr/ ml were observed, respectively.
Għal desloratadine, deher li l- medja ta ’ l- ogħla konċentrazzjonijiet fil- plażma fi stat fiss (Cmax u AUC (0- 12 h)) kienu madwar 1. 7 ng/ ml u 16 ng• hr/ ml, rispettivament kien osservat.
For pseudoephedrine, mean steady state peak plasma concentrations (Cmax and AUC (0-12 h)) of 459 ng/ ml and 4,658 ng• hr/ ml were observed.
Għal pseudoephedrine deher li l- medja ta ’ l- ogħla konċentrazzjonijiet fil- plażma fi stat fiss (Cmax u AUC (0- 12 h) kienu madwar 459 ng/ ml u 4, 658 ng• hr/ ml kien osservat.
In a series of pharmacokinetic and clinical trials, 6% of the subjects reached a higher concentration of desloratadine.
F’ serje ta ’ provi kliniċi u farmakokinetiċi, 6% ta ’ l- individwi kisbu konċentrazzjoni ogħla b’ desloratadine.
2%) however the safety profile of these subjects was not different from that of the general population.
Il- prevalenza ta ’ dan il- finotip ta’ metabolizzaturi dgħajfa kienet akbar fost adulti suwed milli fl- adulti Kawkażi (18% vs 2%) madankollu l- profil ta ’ sigurtà f’ dawn l- individwi ma kienx differenti minn dak tal- popolazzjoni ġenerali.
In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult subjects, four subjects were found to be poor metabolisers of desloratadine.
Fi studju farmakokinetiku b’ ħafna dożi li sar bl - għamla tal- pillola f’ individwi adulti b’ saħħithom, erba ’ individwi instabu li kienu metabolizzaturi dgħajfa ta ’ desloratadine.
These subjects had a Cmax concentration about 3-fold higher at approximately 7 hours with a terminal phase half-life of approximately 89 hours.
Dawn l- individwi kellhom konċentrazzjoni Cmax madwar 3 darbiet ogħla f’ madwar 7 sigħat b’ half- life fil- fażi terminali ta ’ madwar 89 siegħa.
Desloratadine is moderately bound (83% - 87%) to plasma proteins.
Desloratadine jeħel b’ mod moderat (83% - 87%) mal- proteini fil- plażma.
Pseudoephedrine sulphate:
Pseudoephedrine sulphate:
Its elimination half-life in humans, at an approximate urinary pH of 6, ranges from 5 to 8 hours.
Il- half- life li biha jitneħħa fil- bniedem, f’ pH ta ’ l- awrina ta ’ madwar 6, tvarja bejn 5 sa 8 sigħat.
The active substance and its metabolite are excreted in urine; 55-75% of the administered dose is excreted unchanged.
Is - sustanza attiva u l- metabolite tagħha jitneħħew fl- awrina; b’ 55- 75% tad- doża li tingħata tiġi mneħħija mingħajr ma tinbidel.
The rate of excretion is accelerated and the duration of action decreased in acidic urine (pH5).
Ir- rata ta ’ tneħħija u ż- żmien kemm iddum l- azzjoni tonqos f’ awrina aċiduża (pH5).
In case of alkalinization of the urine, a partial resorption takes place.
F’ każ li l- awrina ssir alkalina, iseħħ risorbiment parzjali.
A component interaction study demonstrated that the exposure (Cmax and AUC) of pseudoephedrine following administration of pseudoephedrine alone was bioequivalent to pseudoephedrine exposure following administration of the Aerinaze tablet.
Studju ta ’ interazzjoni tal- komponent wera li l- esponiment (Cmax u AUC) ta ’ pseudoephedrine wara l - għotja ta ’ pseudoephedrine waħdu kienet bioekwivalenti għall- esponiment ta ’ pseudoephedrine wara l - għotja ta ’ pillola Aerinaze.
Therefore absorption of pseudoephedrine was not affected by the Aerinaze formulation.
Għalhekk l- assorbiment ta ’ pseudoephedrine ma kienx effettwat bil - formulazzjoni ta ’ Aerinaze.
Pseudoephedrine is presumed to cross the placenta and the haematoencephalic barrier.
Jista ’ jiġi assumat li pseudoephedrine jaqsam mill- plaċenta u l- barriera ħematoenċefalika.
The active substance is excreted in breast milk of lactating women.
Is- sustanza attiva titneħħa mal- ħalib tas- sider ta ’ nisa li jkollhom il- ħalib.
No pre-clinical studies have been performed with Aerinaze.
Ma sarux studji ta ’ qabel l- użu kliniku b’ Aerinaze.
However, non-clinical data with desloratadine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction.
Madankollu, informazzjoni li mhiex klinika b’ desloratadine, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin.
The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.
In- nuqqas ta ’ potenzjal karċinoġenu intwera bi studji li saru b’ desloratadine u loratadine.
8 The combination of loratadine/ pseudoephedrine sulphate used in acute and multiple-dose studies, exhibited a low order of toxicity.
Il- kombinazzjoni ta ’ loratadine/ pseudoephedrine sulphate li ntużat fi studji b’ ħafna dożi u akuti, kien anqas tossiku.
The combination was not more toxic than their individual components, and observed effects were generally related to the pseudoephedrine component.
Il- kombinazzjoni ma kienitx aktar tossika mill- komponenti individwali u l- effetti li dehru kienu ġeneralment relatati mal- komponent pseudoephedrine.
During reproductive toxicity studies, the combination of loratadine/ pseudoephedrine was not teratogenic when administered orally to rats at doses up to 150 mg/ kg/ day and rabbits at doses up to 120 mg/ kg/ day.
Waqt studji dwar it- tossiċità fuq is- sistema riproduttiva, il- kombinazzjoni ta ’ loratadine/ pseudoephedrine ma kienitx teratoġenika meta ngħatat orali lill- firien b’ dożi sa ’ 150 mg/ kg/ jum u fniek b’ dożi sa 120 mg/ kg/ jum.
Blue, immediate-release layer: maize starch microcrystalline cellulose edetate disodium citric acid stearic acid colorant (Indigo Carmine E132 Aluminum lake).
8 maize starch microcrystalline cellulose edetate disodium citric acid stearic acid Kulur (Indigo Carmine E132 Aluminum lake).
White, sustained-release layer: hypromellose 2208 microcrystalline cellulose povidone K30 silicon dioxide magnesium stearate.
Saff abjad li jintreħa bil- mod: hypromellose 2208 microcrystalline cellulose povidone K30 silicon dioxide magnesium stearate.
Keep the blisters in the outer carton.
Żomm il- folji fil- kartuna ta ’ barra.
Aerinaze is supplied in unit dose blisters comprised of laminate blister film and foil lidding.
Aerinaze jiġi f’ folji b’ doża waħda li jinkludu rita laminata tal- folja u kisja tal- fojl.
The blister consists of clear polychlortrifluorethylene/ polyvinyl chloride (PCTFE/ PVC) film, sealed with a vinyl heat seal coated aluminum foil.
Il- folja hi magħmula minn rita ċara ta ’ polychlortrifluorethylene/ polyvinyl chloride (PCTFE/ PVC), siġillata b’ fojl ta ’ l- aluminium miksi b’ vinyl siġillat bis- sħana.
Paper and/ or polyester may be added to the outer surface of the foil.
Karta u/ jew polyester jistgħu jiġu miżjuda mas- superfiċje ta ’ barra tal- fojl.
Pack sizes of 2, 4, 7, 10, 14 and 20 tablets.
Pakketti f’ daqsijiet ta ’ 2, 4, 7, 10, 14 u 20 pillola.
MARKETING AUTHORISATION HOLDER
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
MARKETING AUTHORISATION NUMBER(S)
DATA TA ’ META ĠIET RIVEDUTA L- KITBA
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
9 Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Industriepark 30 2220 Heist-op-den-Berg Belgium
Industriepark 30 2220 Heist- op- den- Berg Il- Belġju
The MAH must ensure that the system of pharmacovigilance, as described in the version dated 21 March 2007 and presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
L- MAH għandu jaċċerta ruħu li sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni datata 21 Marzu 2007 u preżentata f’ Module 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis - Suq, tkun imwaqqfa u taħdem qabel u waqt li l- prodott ikun fis- suq.
BOX OF 2, 4, 7, 10, 14, 20 MODIFIED-RELEASE TABLETS
KAXXA TA ’ 2, 4, 7, 10, 14, 20 PILLOLA LI TERĦI L- MEDIĊINA B’ MOD MODIFIKAT
Aerinaze 2.5 mg/ 120 mg modified-release tablets desloratadine/ pseudoephedrine (as sulphate)
Aerinaze 2. 5 mg/ 120 mg pilloli li jerħu l- mediċina b’ mod modifikat desloratadine/ pseudoephedrine (bħala sulphate)
2 modified-release tablets 4 modified-release tablets 7 modified-release tablets 10 modified-release tablets 14 modified-release tablets 20 modified-release tablets
2 pilloli li jerħu l- mediċina b’ mod modifikat 4 pilloli li jerħu l- mediċina b’ mod modifikat 7 pilloli li jerħu l- mediċina b’ mod modifikat 10 pilloli li jerħu l- mediċina b’ mod modifikat 14- il pillola li jerħu l- mediċina b’ mod modifikat 20 pillola li jerħu l- mediċina b’ mod modifikat
Swallow the tablet whole with water.
Ibla ’ l- pillola sħieha bl- ilma.
Do not crush, break or chew.
M’ għandekx tgħaffiġha, tifqagħha jew togħmodha.
15 EXP
15 Żomm il- folji fil- kartuna ta ’ barra.
SP Europe Rue de Stalle 73 B-1180 Bruxelles, Belgium
Detentur ta ’ l- Awtorizzazzjoni Għat- Tqegħid fis- Suq SP Europe Rue de Stalle 73 B- 1180 Bruxelles, Il- Belġju
16 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BOX OF 2, 4, 7, 10, 14, 20 MODIFIED-RELEASE TABLETS
KAXXA TA ’ 2, 4, 7, 10, 14, 20 PILLOLI LI JERĦU L- MEDIĊINA B’ MOD MODIFIKAT
Aerinaze 2.5 mg/ 120 mg modified-release tablet desloratadine/ pseudoephedrine (as sulphate)
Aerinaze 2. 5 mg/ 120 mg pillola li terħi l- mediċina b’ mod modifikat desloratadine/ pseudoephedrine (bħala sulphate)
What Aerinaze is and what it is used for 2.
X’ inhu Aerinaze u għalxiex jintuża 2.
Before you take Aerinaze 3.
Qabel ma tieħu Aerinaze 3.
How to take Aerinaze 4.
Kif għandek tieħu Aerinaze 4.
How to store Aerinaze 6.
Kif taħżen Aerinaze 6.
WHAT AERINAZE IS AND WHAT IT IS USED FOR
X’ INHU AERINAZE U GĦALXIEX JINTUŻA
Aerinaze tablets contain a combination of two medicines, an antihistamine and a decongestant.
Il- pilloli Aerinaze fihom kombinazzjoni ta ’ żewġ mediċini, anti- histaminiku u dikonġestjonant.
Antihistamines help to reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced by the body.
L- anti - histaminiċi jgħinu biex inaqqsu s- sintomi allerġiċi billi jevitaw l- effetti ta ’ sustanza msejħa histamina, li jipproduċi l- ġisem.
Decongestants help to clear nasal congestion.
Dikonġestjonanti jgħinu biex jiftħu l- konġestjoni fl- imnieħer.
Aerinaze tablets relieve symptoms associated with seasonal allergic rhinitis (hay fever), such as, sneezing, runny or itchy nose, and eyes, when accompanied by nasal congestion.
Il- pilloli Aerinaze iserrħu s- sintomi assoċjati ma ’ rajnajtis allerġiku ta ’ l- istaġun (hay fever), bħal għatis, imnieħer iqattar jew ħakk fl- imnieħer, u fl- għajnejn, meta jkun hemm ukoll imnieħer imblukkat.
BEFORE YOU TAKE AERINAZE
QABEL MA TIEĦU AERINAZE
Do not take Aerinaze
Tieħux Aerinaze
- if you are allergic (hypersensitive) to desloratadine, loratadine, pseudoephedrine or to any of the
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal desloratadine, loratadine,
other ingredients of Aerinaze.
pseudoephedrine jew sustanzi oħra ta ’ Aerinaze.
- if you are also receiving heart or blood pressure medicine.
- jekk qed tirċievi wkoll mediċini għall- qalb jew għall- pressjoni tad- demm.
- if you have glaucoma, difficulty in urinating, urinary tract blockage, high blood pressure, heart or
- jekk għandek glawkoma, tbati biex tgħaddi l- awrina, imblukkar fil- passaġġ ta ’ l- awrina,
blood vessel disease, a history of stroke, or an overactive thyroid.
pressjoni għolja tad- demm, mard tal- qalb jew tal- vini tad- demm, passat mediku ta ’ puplesija, jew għandek tirojde attiva żżejjed.
- Tell your doctor if you are receiving monoamine oxidase (MAO) inhibitor (a class of antidepressant
- Għid lit- tabib tiegħek jekk qed tirċievi terapija b’ inibituri ta ’ monamine oxidase (MAO) (klassi
agents) therapy or have stopped taking these types of medicines within the last 14 days.
ta ’ mediċini kontra d- dipressjoni), jew jekk waqaft tieħu dawn it- tipi ta ’ mediċini f’ dawn l- aħħar 14- il ġurnata.
Take special care with Aerinaze Certain conditions may make you unusually sensitive to the decongestant pseudoephedrine contained in this medicine.
Oqgħod attent ħafna b’ Aerinaze Ċerti kundizzjonijiet jistgħu jagħmluk sensittiv b’ mod mhux tas- soltu għad- dekonġestjonant pseudoephedrine li hemm f’ din il- mediċina.
Before taking Aerinaze, tell your doctor or pharmacist:
Qabel ma tieħu Aerinaze, għid lit- tabib jew lill- ispiżjar tiegħek:
- if you are 60 years of age or older.
- jekk għandek 60 sena jew aktar.
Older adults may be more sensitive to the effects of this
Adulti aktar anzjani jistgħu jkunu aktar sensittivi għall- effetti
medicine.
ta ’ din il- mediċina.
- if you have eye problems (such as increased pressure in the eye or glaucoma), diabetes mellitus
- jekk għandek problemi f’ għajnejk (bħal żieda fil- pressjoni ta ’ ġo għajnejk jew glawkoma),
(sugar diabetes), stenosing peptic ulcer (ulcer leading to the narrowing of the stomach, small intestine or esophagus), pyloral or duodenal blockage (intestine blockage), vesical cervix blockage
dijabete mellitus (dijabete taz- zokkor), ulċera fl- istonku bi stenożi (ulċera li twassal biex l - istonku, l- musrana jew l- esofagu jidjiequ), imblukkaġġ tal- pilori jew tad- duwodenu (sadda fl - imsaren), imblukkaġġ fiċ- cervika vessikali (sadda ta ’ l- għonq tal- bużżieqa ta ’ l- awrina), passat
19 (bladder neck blockage), previous history of bronchospasm (difficulty breathing due to tightening of the lung muscles), prostate enlargement or problems with your liver, kidney, or bladder.
19 mediku ta ’ bronkospażmu (tbati biex tieħu n- nifs minħabba li jinġibdu l- muskoli tal- pulmun), tkabbir tal- prostata jew problemi bil- fwied, kliewi jew bużżieqa ta ’ l- awrina tiegħek.
- if you are scheduled to have surgery, because you may have to stop taking Aerinaze for a few days.
- jekk għandek skedata operazzjoni, minħabba li jista ’ jkollok twaqqaf Aerinaze għal ftit ġranet.
- if you are taking digitalis, a medicine used to treat certain heart disorders, because the dosage may
- jekk qed tieħu diġitalis, mediċina li tintuża għal kura ta ’ ċerti tipi ta ’ mard tal- qalb, minħabba li
- if you are taking α -methyldopa, mecamylamine, reserpine, veratrum alkaloids and guanethidine for
d- dużaġġ jista ’ jkollu bżonn jiġi aġġustat. jekk qed tieħu α- methyldopa, mecamylamine, reserpine, veratrum alkaloids u guanethidine għal
blood pressure, because the dose may need to be adjusted.
pressjoni tad- demm, minħabba li d- dużaġġ jista ’ jkollu bżonn jiġi aġġustat.
- if you are taking decongestants (oral or nasal), appetite suppressants (diet pills), or amphetamines,
- jekk qed tieħu dikonġestjonanti (orali jew mill- imnieħer), pilloli li jaqtgħu l- aptit (pilloli tad -
because together with Aerinaze, these medicines may raise your blood pressure.
dieta) jew amphetamines, għax ma ’ Aerinaze, dawn il- mediċini jistgħu jgħollulek il- pressjoni tad- demm.
- if you are taking ergot alkaloids (such as dihydroergotamine, ergotamine, or methylergometrine) for
- jekk qed tieħu ergot alkaloids (bħal dihydroergotamine, ergotamine, jew methylergometrine)
migraines.
għall- emikranji.
Together with Aerinaze, these medicines may raise your blood pressure.
Flimkien ma ’ Aerinaze, dawn il- mediċini jistgħu jgħollulek il- pressjoni tad - demm.
- if you are taking linezolide (an antibiotic), bromocriptine (for infertility or Parkinson’ s disease),
- jekk qed tieħu linezolide (antibijotiku), bromocriptine (għall- infertilità jew marda ta ’ Parkinson),
cabergoline, lisuride and pergolide (for Parkinson’ s disease).
cabergoline, lisuride u pergolide (għal marda ta ’ Parkinson).
Together with Aerinaze, these medicines may raise your blood pressure.
Flimkien ma ’ Aerinaze, dawn il - mediċini jistgħu jgħollulek il- pressjoni tad- demm.
- if you are taking antacids, because they may increase the effectiveness of Aerinaze.
- jekk qed tieħu antaċidi, għax jistgħu jgħamlu Aerinaze aktar effettiv.
- if you are taking kaolin (for diarrhoea), because it may lower the effectiveness of Aerinaze.
- jekk qed tieħu kaolin (għad- dijarea), għax jista ’ jgħamel Aerinaze anqas effettiv.
Tell your doctor if you experience or are diagnosed with any of the following: • high blood pressure • a fast or pounding heart beat • abnormal heart rhythm • feeling sick and headache or increase headache while using Aerinaze.
Għid lit- tabib tiegħek jekk tħoss jew tiġi dijanjostikat b’ xi wieħed minn dawn li ġejjin: • pressjoni għolja tad- demm • qalb tħabbat mgħaġġla bil- qawwi • ritmu tal- qalb mhux normali • tħossok ma tiflaħx jew uġigħ ta ’ ras jew jiżdiedlek l- uġigħ ta ’ ras waqt li tkun qed tuża Aerinaze.
Your doctor may advise you to stop your treatment.
It- tabib tiegħek jista ’ jtik parir biex twaqqaf il- mediċina tiegħek.
One of the medicines in Aerinaze, pseudoephedrine sulphate, has the potential to be abused and large doses of pseudoephedrine sulphate can be toxic.
Wieħed mill- mediċini li hemm f’ Aerinaze, pseudoephedrine sulphate, jista ’ jiġi abbużat u dożi għoljin ta ’ pseudoephedrine sulphate jistgħu jkunu tossiċi.
Laboratory Tests Stop taking Aerinaze at least 48 hours before you have any skin tests.
Testijiet tal- Laboratorju Waqqaf Aerinaze mill- anqas 48 siegħa qabel ma tgħamel xi testijiet tal- ġilda.
Athletes taking Aerinaze may have positive doping-tests.
L- atleti li jieħdu Aerinaze jkollhom testijiet doping pożittivi.
Taking Aerinaze with food and drink Aerinaze tablets may be taken with or without food.
Meta tieħu Aerinaze ma ’ l- ikel u max- xorb Il- pilloli Aerinaze jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breast-feeding.
Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina waqt it- tqala jew treddigħ.
Taking Aerinaze is not recommended if you are pregnant.
Mhux rakkomandat li tieħu Aerinaze jekk ħriġt tqila.
Decreased milk production in nursing mothers has been reported with pseudoephedrine, a component of Aerinaze.
Tnaqqis fil- produzzjoni tal- ħalib f’ nisa li jreddgħu kien rappurtat bi pseudoephedrine, wieħed mill - komponenti ta ’ Aerinaze.
If you are breast-feeding taking Aerinaze is not recommended.
Jekk qed tredda ’ mhux rakkomandat li tieħu Aerinaze.
Driving and using machines At the recommended dose, Aerinaze is not expected to cause you to be drowsy or less alert.
Sewqan u tħaddim ta ’ magni Bid- doża rakkomandata, Aerinaze mhux mistenni li jikkawża tħeddil jew inaqqaslek il- viġilanza.
However, very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
Madankollu, rari ħafna xi nies ħassewhom bi ngħas, li seta jeffettwalhom il- ħila biex isuqu jew iħaddmu magni.
HOW TO TAKE AERINAZE
KIF GĦANDEK TIEĦU AERINAZE
20 Always take Aerinaze tablets exactly as your doctor has told you.
20 Dejjem għandek tieħu Aerinaze skond il- parir tat- tabib.
Adults and adolescents 12 years of age and over:
Adulti u adolexxenti minn 12- il sena ’ l fuq:
Take one Aerinaze tablet twice daily with a glass of water, with or without food.
Ħu pillola Aerinaze waħda darbtejn kuljum ma ’ tazza ilma, ma ’ likel jew mingħajr ikel.
Swallow the tablet whole; do not crush, break or chew the tablet before swallowing.
Ibla ’ l- pillola sħieħa, tgħaffiġiex, taqsamhiex jew tigdimhiex qabel ma tiblaha.
Aerinaze should not be used in children less than 12 years of age.
Aerinaze m’ għandux jintuża fi tfal taħt it- 12- il sena.
Do not take more Aerinaze tablets than recommended on the label.
M’ għandekx tieħu aktar pilloli Aerinaze milli hemm imniżżel fit- tikketta.
Do not take Aerinaze tablets more often than recommended.
Tieħux pilloli Aerinaze aktar ta ’ spiss milli rrakkomandat.
Do not take this medicine for more than 10 days continuously unless your doctor tells you to do so.
Tieħux din il- mediċina għal aktar minn 10 ijiem wara xulxin sakemm ma jgħidlekx it- tabib tiegħek biex tagħmel hekk.
If you take more Aerinaze than you should If you take more Aerinaze than you were told to, tell your doctor or pharmacist immediately.
Jekk tieħu Aerinaze aktar milli suppost Jekk tieħu Aerinaze aktar milli qalulek, għid lit- tabib jew lill- ispiżjar tiegħek mill- ewwel.
If you forget to take Aerinaze If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule.
Jekk tinsa tieħu Aerinaze Jekk tinsa tieħu d- doża fil- ħin, ħudha kemm jista ’ jkun malajr u imbagħad mur lura għall- iskeda regolari tad- dużaġġ.
Like all medicines, Aerinaze can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Aerinaze jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Contact a doctor or pharmacist if you have any reaction at all to Aerinaze that continues, is bothersome or that you think is serious.
Għamel kuntatt ma ’ tabib jew spiżjar jekk ikollok kwalunkwe reazzjoni għal Aerinaze li tippersisti, iddejqek jew taħseb li hi serja.
Common (at least 1 in 100 patients) side effects associated with Aerinaze include: fast heartbeat, restlessness with increased body movement, dry mouth, dizziness, sore throat, decreased appetite, constipation, sugar in urine, increased sugar in blood, thirst, tiredness, headache, trouble sleeping, nervousness, and drowsiness.
Effetti sekondarji komuni (mill- anqas 1 f’ kull 100 pazjent) assoċjati ma ’ Aerinaze jinkludu: qalb tħabbat mgħaġġla, nuqqas ta ’ kwiet b’ żieda fil- movimenti tal- ġisem, ħalq xott, sturdament, uġigħ fi griżmejk, nuqqas ta’ aptit, stitikezza, zokkor fl- awrina, żieda taz- zokkor fid- demm, għatx, għeja, uġigħ ta ’ ras, tbati biex torqod, nervi u ngħas.
Uncommon (at least 1 in 1,000 patients) side effects include: pounding or irregular heart beat, increased body movement, flushing, hot flushes, confusion, blurry vision, dry eyes, nose bleeds, irritated nose, inflammation of the nose, runny nose, inflammation of the sinus, dry throat, stomach pain, stomach flu, nausea, abnormal stool, painful or difficult urination, problems urinating, changes in frequency of urination, itching, chills, decreased sense of smell, abnormal liver function tests, agitation, anxiety, and irritability.
Effetti sekondarji mhux komuni (mill- anqas 1 f’ kull 1, 000 pazjent) jinkludu: qalb tħabbat bil- qawwa jew b’ mod irregolari, żieda fil- movimenti tal- ġisem, issir ruxxan, fwawar ta ’ sħana, konfużjoni, vista mċajpra, għajnejn xotti, tinfaraġ, imnieħer irritat, infjammazzjoni f’ imnieħrek, imnieħrek iqattar, infjammazzjoni tas- sinus, grieżem xotti, uġigħ fl- istonku, flu ta’ l- istonku, tqalligħ, ippurgar mhux normali, tweġġa ’ jew tbati biex tgħaddi l- awrina, problemi biex tgħaddi l- awrina, tgħaddi l- awrina bi frekwenza mhux tas- soltu, ħakk, dehxiet, nuqqas ta ’ xamm, testijiet tal- funzjoni tal- fwied mhux normali, aġitazzjoni, ansjetà u irritabilità.
During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Waqt it- tqegħid fis- suq ta ’ desloratadine, każijiet ta ’ reazzjonijiet ta ’ allerġija serji (tbatija biex tieħu n - nifs, tħarħir, ħakk, ħorriqija u nefħa) u raxx kienu rrappurtati rari ħafna.
Cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, hallucinations, dizziness, drowsiness, inability to sleep, muscle pain, seizures, restlessness with increased body movement, liver inflammation and abnormal liver function tests have also been reported very rarely.
Każijiet ta ’ palpitazzjoni, qalb tħabbat mgħaġġla, uġigħ fl- istonku, tqalligħ (tħossok ma tiflaħx), rimettar, stonku imqalleb, dijarea, alluċinazzjonijiet, sturdament, tħeddil, ma tkunx tista ’ torqod, uġigħ fil- muskoli, aċċessjonijiet, nuqqas ta ’ kwiet b’ żieda fil- movimenti tal- ġisem, infjammazzjoni tal- fwied u testijiet tal- funzjoni tal- fwied anormali kienu rrappurtati rari ħafna.
HOW TO STORE AERINAZE
KIF TAĦŻEN AERINAZE
Keep out of the reach and sight of children.
21 Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.
Do not use Aerinaze after the expiry date which is stated on the blister.
Tużax Aerinaze wara d- data ta ’ skadenza li tidher fuq il- folja.
Do not store above 30°C.
Taħżinx f’ temperatura ’ l fuq minn 30ºC.
What Aerinaze contains
X’ fih Aerinaze:
- The active substances are desloratadine and pseudoephedrine (as sulphate)
- Is- sustanzi attivi huma desloratadine u pseudoephedrine (bħala sulphate)
- Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine (as sulphate).
- Kull pillola fiha 2. 5 mg desloratadine u 120 mg pseudoephedrine (bħala sulphate).
cellulose, edetate disodium, citric acid, stearic acid and colorant (Indigo Carmine E132 Aluminum lake).
Sustanzi mhux attivi fis- saff ċelesti li jinħeles il- mediċina mill- ewwel: maize starch, microcrystalline cellulose, edetate disodium, citric acid, stearic acid and kolorant (Indigo Carmine E132 Aluminum lake).
cellulose, povidone K30, silicon dioxide and magnesium stearate.
Sustanzi mhux attivi fis- saff abjad li jeħles il- mediċina bil- mod: hypromellose 2208, microcrystalline cellulose, povidone K30, silicon dioxide and magnesium stearate.
What Aerinaze looks like and contents of the pack
Id- Dehra ta ’ Aerinaze u l- kontenuti tal- pakkett:
Aerinaze is a blue and white oval bi-layer tablet with “ D12” branded on the blue layer.
Aerinaze hija pillola ovali b’ żewġ saffi waħda ċelesti u l- oħra abjad b ’ ” D12 ” immarkata fuq is- saff ċelesti.
Aerinaze tablets are packed as 2, 4, 7, 10, 14, or 20 tablets in blisters comprised of laminate blister film and foil lidding.
Il- pilloli Aerinaze jiġu f’ pakketti ta ’ 2, 4, 7, 10, 14, jew 20 pillola f’ folji li jkun fihom rita laminate u kisja bil- fojl.
SP Europe Rue de Stalle 73 B-1180 Bruxelles Belgium.
SP Europe Rue de Stalle 73 B- 1180 Bruxelles Il- Belġju.
Industriepark 30 B-2220 Heist-op-den-Berg Belgium.
Industriepark 30 B- 2220 Heist- op- den- Berg Il- Belġju.
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (ukoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Aerius?
X' inhu Aerius?
Aerius is a medicine containing the active substance desloratadine.
Aerius hu mediċina li fiha s- sustanza attiva desloratadina (desloratadine).
It is available as a 5 mg tablet, a 5 mg oral lyophilisate (dispersible tablet), 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ ml syrup and a 0.5 mg/ ml oral solution.
Hija disponibbli bħala pillola ta '5 mg, pillola lijofilizzata (li tinħall) ta' 5 mg, pilloli li jinħallu fil- ħalq ta '2. 5 mg u ta' 5 mg, mistura (xropp) ta '0. 5 mg/ ml u soluzzjoni orali ta' 0. 5 mg/ ml.
What is Aerius used for?
Għal xiex jintuża Aerius?
Aerius is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Aerius jintuża għal serħan mis- sintomi tar- rinite allerġika (infjammazzjoni tal- passaġġi tan- nifs ikkawżata minn allerġija, per eżempju riħ tal- ħuxlief (hay fever) jew allerġija għad- dust mites) jew urtikarja (kundizzjoni tal- ġilda kkawżata minn allerġija, b' sintomi ta 'ħakk u ħorriqija).
The medicine can only be obtained with a prescription.
Il- mediċina tista 'tinkiseb biss b' riċetta medika.
How is Aerius used?
Kif jintuża Aerius?
The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.
Id- doża rakkomandata għall- adulti u l- adoloxxenti (ta '12- il sena jew aktar) hi ta' 5 mg darba kuljum.
The dose in children depends on their age.
Id- doża fit- tfal tvarja skond l- età tagħhom.
For children from one to five years of age, the dose is 1.25 mg once a day, taken as 2.5 ml syrup or oral solution.
Għal tfal ta 'bejn sena u ħames snin, id- doża hi ta' 1. 25 mg darba kuljum, li tittieħed bħala 2. 5 ml mistura jew soluzzjoni orali.
For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet.
Għal tfal ta 'bejn sitt snin u ħdax- il sena, id- doża hi ta' 2. 5 mg darba kuljum, meħuda bħala 5 ml mistura jew soluzzjoni orali, jew bħala pillola ta '2. 5 mg li tinħall fil- ħalq.
Adults and adolescents can use any form of the medicine.
L- adulti u l- adoloxxenti jistgħu jużaw kwalunkwe għamla tal - mediċina.
Aerius can be taken with or without food.
Aerius jista 'jittieħed fuq stonku vojt jew le.
How does Aerius work?
Kif jaħdem Aerius?
The active substance in Aerius, desloratadine, is an antihistamine.
Is- sustanza attiva f' Aerius, desloratadina, hija antistaminiku.
It works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself.
Id- desloratadina taħdem billi timblokka r - riċetturi li normalment teħel magħhom l- istamina, sustanza fil- ġisem li tikkawża s- sintomi ta 'l - allerġija.