qanastek/EMEA-V3 huggingface dataset:
Diarrhoea Psychiatric disorders
Dijareja Mard psikjatriku
1.0%
1. 0%
1.8%
1. 8%
Rhinitis Body as a whole – general disorders
Rinite Il- Ġisem kollu kemm hu - mard ġenerali
1.4%
1. 4%
Post-marketing experience
Esperjenza ta ’ wara li jitqiegħed fis- suq
In addition to the adverse effects reported during clinical studies and listed above, isolated cases of the following adverse drug reactions have been reported in post-marketing experience.
Minnbarra l- effetti mhux mixtieqa li ġew irrappurtati waqt studji kliniċi li huma mniżżla hawn fuq, każi iżolati ta ’ l- effetti mhux mixtieqa li ġejjin kienu rrappurtati wara t- tqegħid fis- suq.
1/ 10,000) are made based on post-marketing experience.
Għal dawn l - effetti mhux mixtieqa li huma rrappurtati anqas frekwentament, frekwenzi ta ’ l- estimi (mhux komuni: ≥1/ 1, 000 għal < 1/ 100, rari: ≥1/ 10, 000 għal < 1/ 1, 000, rari ħafna: < 1/ 10, 000) huma mfassla bbażati fuq rapporti ta ’ wara t- tqegħid fis- suq.
Blood and lymphatic disorders:
Mard tad- demm u tas- sistema limfatika:
Very rare: thrombocytopenia
Rari ħafna: tromboċitopenja
Rare: hypersensitivity Very rare: anaphylactic shock
Rari: sensittivita` eċċessiva Rari ħafna: xokk anafillatiku
Uncommon: agitation Rare: aggression, confusion, depression, hallucination, insomnia Very rare: tic
Mhux komuni: aggressjoni Rari: aġitazzjoni, konfużjoni, depressjoni, alluċinazzjonijiet, insomnja Rari ħafna: tikk
Uncommon: paraesthesia Rare: convulsions, movements disorders Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia
Mhux komuni: parestesja Rari: aċċessjonijiet, mard tal- moviment Rari ħafna: disġewsja, sinkope, rogħda, distonja, diskinesja
Very rare: accommodation disorder, blurred vision, oculogyration
Rari ħafna: disturb biex tiffoka l- vista, vista mċajpra, okulogirazzjoni
Rare: tachycardia
Rari: takikardja
Gastro-intestinal disorders:
Mard gastro- intestinali:
Uncommon: diarrhoea
Mhux komuni: dijareja
Hepatobiliary disorders:
Mard tal- fwied u tal- marrara:
Rare: hepatic function abnormal (increased transaminases, alkaline phosphatase, γ -GT and bilirubin)
Rari: funzjoni tal- fwied anormali (żieda fit- transaminases, alkaline phosphatase, γ- GT u bilirubin)
Skin and subcutaneous tissue disorders:
Mard tal- ġilda u t- tessut ta ’ taħt il- ġilda:
Uncommon: pruritus, rash Rare: urticaria Very rare: angioneurotic oedema, fixed drug eruption
Mhux komuni: ħakk, raxx, Rari: urtikarja, Rari: edema anġjonewrotika, eruzzjoni fissa għall- mediċina
Renal and urinary disorders:
26 Mard tal- kliewi u tas- sistema urinarja:
Very rare: dysuria, enuresis
Rari ħafna: disurja, enureżi
28 General disorders and administration site conditions:
Mard ġenerali u kundizzjonijiet ta ’ mnejn jingħata:
Uncommon: asthenia, malaise Rare: oedema
Mhux komuni: astenja, telqa kbira, Rari: edima
Rare: weight increased
Rari: żieda fil- piż
Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect.
Is- sintomi li ġew osservati wara doża eċċessiva b’ cetirizine huma assoċjati ma ’ effetti tas- CNS jew ma ’ effetti li jissuġġerixxu effett anti- kolinerġiku.
Adverse events reported after an intake of at least 5 times the recommended daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.
Effetti mhux mixtieqa rrappurtati wara li tittieħed qwantita` ta ’ mill- inqas 5 darbiet id- doża rrakkomandata huma: konfużjoni, dijareja, sturdament, għeja, uġigħ ta ’ ras, telqa, mydriasis, ħakk, irrekwitezza, sedazzjoni, ngħas tqil, sturdament, takikardja, rogħda, u żamma ta ’ l- awrina.
Management
Maniġment
There is no known specific antidote to cetirizine.
M’ hemmx antidotu speċifiku għal cetirizine.
Should overdose occur, symptomatic or supportive treatment is recommended.
Jekk ikun hemm doża eċċessiva, huwa rrakkomandat trattament sintomatiku jew ta ’ support.
Gastric lavage should be considered following ingestion of a short occurrence.
Għandu jiġi kkunsidrat il- ħasil ta ’ l- istonku jekk ma jkunx ilu li ttieħdet il- mediċina mill- ħalq.
Cetirizine is not effectively removed by dialysis.
Cetirizine ma jissaffiex effettivament bid- dijaliżi.
Piperazine derivatives, ATC code:
Kategorija farmakoterapewtika: derivattivi ta ’ piperazine, Kodiċi ATC:
Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1- receptors.
Cetirizine, prodott tal- metaboliżmu ta ’ hydroxyzine fil- bniedem, huwa antagonist qawwi u selettiv ta ’ riċetturi periferali tip H1.
In vitro receptor binding studies have shown no measurable affinity for other than H1- receptors.
Studji in vitro fuq ir- rabta mar- riċetturi ma wrew ebda affinita` għal riċetturi ħlief dawk H1.
In addition to its anti-H1 effect, cetirizine was shown to display anti-allergic activities: at a dose of 10 mg once or twice daily, it inhibits the late phase recruitment of eosinophils, in the skin and conjunctiva of atopic subjects submitted to allergen challenge.
Minbarra l- effett tiegħu kontra H1, instab li cetirizine għandu attivita` kontra l- allerġiji: f’ doża ta ’ 10 mg darba jew darbtejn kuljum, jinibixxi li l- eosinofili jieħdu sehem fl- aħħar fażi tal- proċess, fil - ġilda u l- kunġunktiva ta ’ persuni atopiċi li ġew sottomessi għal sfida bl- allerġeni.
Studies in healthy volunteers show that cetirizine, at doses of 5 and 10 mg strongly inhibits the wheal and flare reactions induced by very high concentrations of histamine into the skin, but the correlation with efficacy is not established.
Studji f’ voluntiera f’ saħħithom juru li cetirizine f’ dożi ta ’ 5 u 10 mg jinibixxi bil- qawwa r - reazzjoniijiet tat- tip ‘ wheal and flare ’ minħabba konċentrazzjonijiet għolja ħafna ta ’ l- istamina fil - ġilda, imma l- korrelazzjoni mal- effikaċja mhijiex stabbilita.
In a 35-day study in children aged 5 to 12, no tolerance to the antihistaminic effect (suppression of wheal and flare) of cetirizine was found.
Fistudju ta - 35- ġurnata fit- tfal ta ’ bejn il- 5 u t- 12- il sena, ma nstabet ebda tolleranza għall- effett ta ’ cetirizine kontra l- istamina (biex trażżan il - ‘ wheal and flare ’).
When a treatment with cetirizine is stopped after repeated administration, the skin recovers its normal reactivity to histamine within 3 days.
Meta trattament b’ cetirizine kien imwaqqaf wara li ngħata ripetutament, il- ġilda ġiet lura għal reattivita` normali għall- istamina li kella qabel fi żmien 3 ijiem.
In a six-week, placebo-controlled study of 186 patients with allergic rhinitis and concomitant mild to moderate asthma, cetirizine 10 mg once daily improved rhinitis symptoms and did not alter pulmonary function.
Fi studju ta ’ sitt ġimgħat ikkontrollat mill- plaċebo ta ’ 186 pazjent b’ rinite allerġika flimkien ma ’ ażżma ħafifa jew moderata, cetirizine 10 mg darba kuljum taffa s- sintomi tar- rinite u ma biddilx il - funzjoni tal- pulmun.
This study supports the safety of administering cetirizine to allergic patients with mild to moderate asthma.
Dan l- istudju jikkonferma s- sigurta` tat- teħid ta ’ cetirizine f ’ pazjenti allerġiċi b’ ażżma ħafifa jew moderata.
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.
27 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.
At the recommended dosage, cetirizine has demonstrated that it improves the quality of life of patients with perennial and seasonal allergic rhinitis.
Fid- dożaġġ irrakkomandat, huwa ċar li cetirizine itejjeb il- kwalita` tal- ħajja tal- pazjenti b ’ rinite allerġika perenni jew staġjonali.
The steady - state peak plasma concentrations is approximately 300 ng/ ml and is achieved within 1.0 ± 0.5 h.
L- ogħla konċentrazzjoni tal- plażma fi stat fiss huwa madwar 300 ng/ ml u jintlaħaq f’ 1. 0 ± 0. 5 siegħa.
No accumulation is observed for cetirizine following daily doses of 10 mg for 10 days.
Ma deheritx akkumulazzjoni b’ cetirizine wara dożi ta ’ 10 mg kuljum għal 10 ijiem.
The distribution of pharmacokinetic parameters such as peak plasma concentration (Cmax) and area under curve (AUC), is unimodal in human volunteers.
Id- distribuzzjoni ta ’ parametri farmakokinetiċi, bħal l- ogħla konċentrazzjoni fil- plażma (Cmax) u l- erja taħt il- kurva (AUC), kienu unimodal f’ voluntiera umani.
The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.
Il - medda t’ assorbiment ta ’ cetirizine mhix imnaqqsa bl- ikel, għalkemm ir- rata t’ assorbiment hija mnaqqsa.
The extent of bioavailability is similar when cetirizine is given as solutions, capsules or tablets.
Il- biodisponibilta` totali hija simili meta cetirizine jingħata bħala soluzzjoni, kapsuli jew pilloli.
The apparent volume of distribution is 0.50 l/ kg.
Milli jidher, il- volum ta ’ distribuzzjoni huwa ta ’ 0. 50 l/ kg.
Plasma protein binding of cetirizine is 93 ± 0.3%.
Ir- rabta ta ’ proteini fil- plażma ta ’ cetirizine hija ta ’ 93 ± 0. 3%.
Cetirizine does not modify the protein binding of warfarin.
Cetirizine ma jbiddilx ir- rabta tal- warfarina mal- proteini.
Cetirizine does not undergo extensive first pass metabolism.
Cetirizine mhux immetaboliżżat estensivament mill- ewwel.
About two third of the dose are excreted unchanged in urine.
Madwar żewġt terżi tad- doża hija mneħħija mhux mibdula fl- awrina.
The terminal half-life is approximately 10 hours.
Il- half life aħħari huwa madwar 10 sigħat.
Cetirizine exhibits linear kinetics over the range of 5 to 60 mg.
Cetirizine għandu kinetika linejari fuq medda bejn 5 sa 60 mg
Special populations
Populazzjonijiet Speċjali L- anzjani:
Following a single 10 mg oral dose, half-life increased by about 50% and clearance decreased by 40% in 16 elderly subjects compared to the normal subjects.
Wara doża waħda ta ’ 10 mg mill- ħalq, il- half- life żdied b’ madwar 50% u l- clearance niżel b ’ 40% f ’ 16 il- pazjent anzjan meta mqabbla ma ’ suġġetti normali.
The decrease in cetirizine clearance in these elderly volunteers appeared to be related to their decreased renal function.
It- tnaqqis fil- clearance ta ’ cetirizine f’ dawn il- voluntiera anzjani deher li kien relatat mat- tnaqqis fil- funzjoni li kellhom tal - kliewi.
The half-life of cetirizine was about 6 hours in children of 6-12 years and 5 hours in children 2-6 years.
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.
In infants and toddlers aged 6 to 24 months, it is reduced to 3.1 hours
F’ tfal żgħar u trabi ta ’ bejn is- 6- 24 il- xahar, dan kien mnaqqas għal 3. 1sigħat.
Renally impaired patients:
Pazjenti b’ indeboliment tal- kliewi:
The pharmacokinetics of the drug were similar in patients with mild impairment (creatinine clearance higher than 40 ml/ min) and healthy volunteers.
Il- farmakokinetika tal- mediċina kienet simili f’ pazjenti b’ indeboliment ħafif (clearance tal- krejatinina iżjed minn 40 ml/ min) u voluntiera f’ saħħithom.
Patients with moderate renal impairment had a 3-fold increase in half-life and 70% decrease in clearance compared to healthy volunteers.
Pazjenti b’ indeboliment moderat tal- kliewi kellhom żieda ta ’ tliet darbiet aktar fil- half- life u tnaqqis ta ’ 70% fil- clearance meta mqabbla ma ’ voluntiera f’ saħħithom.
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.
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.
Cetirizine was poorly cleared by haemodialysis.
Cetirizine ma kienx imsaffi tajjeb b’ emodijaliżi.
Dosing adjustment is necessary in patients with moderate or severe renal impairment (see section 4.2).
Hemm bżonn aġġustament fid- dożaġġ f’ pazjenti b’ indebolament moderat jew sever tal- kliewi( ara sezzjoni 4. 2).
Patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis) given 10 or 20 mg of cetirizine as a single dose had a 50% increase in half-life along with a 40% decrease in clearance compared to healthy subjects.
Pazjenti b’ mard kroniku tal- fwied (epato- cellulari, kolestatiku u ċirrożi) li ngħataw 10 mg jew 20 mg ta ’ cetirizine bħala doża waħda kellhom 50% żieda fil- half- life flimkien ma ’ tnaqqis ta ’ 40% tal- clearance meta mqabbla ma ’ suġġetti f’ saħħithom.
Dosing adjustment is only necessary in hepatically impaired patients if concomitant renal impairment is present.
Hemm bżonn aggustament tad- dożaġġ f’ pazjenti b’ indeboliment tal- fwied, biss jekk ikun hemm ukoll indeboliment tal- kliewi.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin.
- Microcrystalline cellulose
- Microcrystalline cellulose
- Colloidal anhydrous silica
- Colloidal anhydrous silica
- Opadry Y-1-7000
- Opadry Y- 1- 1700
- Hydroxypropylmethylcellulose (E 464)
- Hydroxypropylmethylcellulose (E 464)
- Titanium dioxide (E 171)
- Titanium dioxide (E 171)
5 years
5 snin.
This medicinal product does not require any special storage conditions.
Dan l- prodott mediċinali m’ għandux bżonn kundizzjonijiet speċjali għal ħażna.
Thermoformed transparent, colorless, physiologically inert PVC blister strip thermosealed by an aluminium foil covered by suitable lac; in a carton box.
Folja tal- PVC li ma jagħmilx reazzjonijiet fiżjoloġiċi, trasparenti, bla kulur u fformata bis- sħana, issiġillata b’ fojl ta ’ l- aluminju u miksija b’ gommalakka xierqa; f’ kaxxa tal- kartun.
Boxes of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, or 100 tablets.
Kaxxi ta ’ 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, jew 100 pillola.
[To be completed nationally] {Name and address} {tel} {fax} {e-mail}
[Biex timtela mill- pajjiż partikolari] [Isem u indirizz] {telefon} {fax} {e- mail}
Zyrtec 10 mg/ ml oral drops, solution
Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 10 mg/ ml taqtir tal- ħalq, soluzzjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari]
One ml of solution contains 10 mg cetirizine dihydrochloride, one drop of solution contains 0.5 mg cetirizine dihydrochloride
Ml wieħed tas- soluzzjoni fiħ 10 mg cetirizine dihydrochloride, taqtira waħda tas- soluzzjoni fiha 0. 5 mg cetirizine dihydrochloride.
Excipients: - one ml of solution contains 1.35 mg methylparahydroxybenzoate
Is- sustanzi mhux attiva: - ml wieħed tas- soluzzjoni fiħ 1. 35 mg methylparahydroxybenzoate
- one ml of solution contains 0.15 mg propylparahydroxybenzoate
- ml wieħed tas- soluzzjoni fiħ 0. 15 mg propylparahydroxybenzoate
Oral drops, solution
Taqtir tal- ħalq, soluzzjoni
Clear and colorless liquid
Likwidu car u bla kulur.
In adults and paediatric patient 2 year and above:
F’ adulti u pazjenti tfal ta ’ sentejn ‘ l fuq:
- Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial
- Cetirizine huwa indikat biex jittaffew minn sintomi nażali u tal- għajnejn ta ’ rinite allerġika tal -
allergic rhinitis.
istaġun u perenni.
- Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.
- Cetirizine huwa indikat għal mistrieħ mis- sintomi ta ’ urtikarja idjopatika kronika.
Children aged from 2 to 6 years:
Tfal ta ’ bejn is- sentejn u s- 6 snin:
2.5 mg twice daily (5 drops twice daily).
2. 5 mg darbtejn kuljum (5 taqtiriet darbtejn kuljum).
5 mg twice daily (10 drops twice daily).
5 mg darbtejn kuljum (10 taqtiriet darbtejn kuljum).
10 mg once daily (20 drops).
10 mg darba kuljum (20 taqtira).
The drops should be poured in a spoon or diluted in water, and taken orally.
It- taqtir irid jiġi mferra ’ ġo mgħarfa jew dilwit fl- likwidu, u jittieħed mill- ħalq.
If dilution is used, it should be considered, especially for administration to children, that the volume of water to which the drops are added, needs to be adapted according to the quantity of water the patient is able to swallow.
Jekk iżżidu bl- ilma, dan għandu jkun ikkunsidrat, speċjalment jekk tatih lit- tfal, skond il- kwantita` t’ ilma li l- pazjent jista ’ jibla ’.
The diluted solution should be taken immediately.
Is- soluzzjoni dilwita għandha tittieħed immedjatament.
Elderly subjects: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.
It- tagħrif ma jissuġġerix li d- doża għandha bżonn titnaqqas f’ pazjenti anzjani, sakemm il- funzjoni tal- kliewi tkun normali.
Patients with moderate to severe renal impairment: there are no data to document the efficacy/ safety ratio in patients with renal impairment.
Pazjenti b’ indeboliment renali moderat għal sever: m’ hemmx tagħrif biex juri l- proporzjon ta ’ effikaċja/ sigurta´ f’ pazjenti b’ indeboliment tal- kliewi.
Since cetirizine is mainly eliminated via renal route (see section 5.2.), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function.
Peress li cetirizine jitneħħa prinċipalment eskret mill- kliewi (ara sezzjoni 5. 2), f’ każi fejn m’ hemmx kura alternattiva, l- intervalli ta ’ bejn doża u oħra jridu jiġu individwalizzati skond il- funzjoni renali.
Refer to the following table and adjust the dose as indicated.
Biex tuża din it- tabella ta ’ dożaġġ, hemm bżonn li jitkejjel il- clearance tal- krejatinina tal -
To use this dosing table, an estimate of the patient’ s creatinine clearance (CLcr) in ml/ min is needed.
31 pazjent (CLcr) f ’ ml/ min.
32
(x 0. 85 ghan − nisa)
Dosing adjustments for adult patients with impaired renal function
Aġġustament fid- dożaġġ għal- pazjenti adulti b ’ indeboliment tal- funzjoni tal- kliewi:
In pediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age and his body weight.
F’ pazjenti pedjatriċi li jbagħatu minn indeboliment renali, id- doża trid tiġi aġġustata fuq bażi individwali wara li jitqies il- clearance tal- kliewi, l- eta`u l- piż tal- pazjent.
Patients with hepatic impairment: no dose adjustment is needed in patients with solely hepatic impairment.
Pazjenti b’ indeboliment epatiku: m’ hemmx bżonn aġġustament tad- doża f’ pazjenti li għandhom biss indeboliment epatiku.
Patients with hepatic impairment and renal impairment: dose adjustment is recommended (see Patients with moderate to severe renal impairment above).
Pazjenti b’ indeboliment kemm tal- fwied u kemm tal- kliewi: aġġustament tad- doża huwa rrakkomandat (ara Pazjenti b’ indeboliment renali moderat għal sever hawn fuq).
Hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to any piperazine derivatives.
Sensittività eċċessiva għas- sustanza attiva, għal xi sustanza mhux attiva, għal hydroxyzine jew għal xi derivattiv ta ’ piperazine.
Patients with severe renal impairment at less than 10 ml/ min creatinine clearance.
Pazjenti bi indeboliment renali sever bi clearance tal- krejatinina ta ’ inqas minn 10 ml/ min.
At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/ l).
Ma kienx hemm effett klinikament sinifikanti f’ dożi terapewtiċi flimkien ma ’ l- alkoħol (livell ta ’ alkoħol fid- demm ta ’ 0. 5 g/ l).
The use of the product is not recommended in infants and toddlers aged less than 2 years.
L- użu tal- prodott mhux irrakkomandat fit- tfal u trabi ta ’ inqas minn sentejn.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
Methyl parahydroxybenzoate u propyl parhydroxybenzoate jista ’ jikkawża reazzjonijiet allerġiċi (li jistgħu idumu biex joħorġu).
Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine.
Mhux mistennija interazzjonijiet b ’ din l- antistamina, minħabba il- profil farmakokinetiku, farmakodinamiku u ta ’ tolleranza ta ’ cetirizine.
Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/ day).
In fatti, ma kienux rappurtati la interazzjonijiet 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).
The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.
32 Il - livell t’ assorbiment ta ’ cetirizine mhux imnaqqas bl- ikel, għalkemm ir- rata ta ’ assorbiment kienet mnaqqsa.
33 4.6 Pregnancy and lactation
4. 6 Tqala u effetti fuq il- ħalib tas- sider
For cetirizine very rare clinical data on exposed pregnancies are available.
Hemm tagħrif kliniku rari ħafna każi ta ’ tqala esposti għal cetirizine.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ fetal development, parturition or postnatal development.
Studji fuq l- annimali ma jurux effetti ħżiena diretti jew indiretti fejn tidħol it- tqala, żvillup ta ’ embriju/ fetu, ħlas jew żvillup ta ’ wara t- tqala.
In these sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.
F’ dawn il- pazjenti sensittivi, l- użu flimkien ma ’ l- alkoħol jew depressanti oħra tas - sistema nervuża ċentrali (CNS) jista ’ jikkawża tnaqqis addizzjonali fil- viġilanża jew indeboliment fil - ħila.
Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache.
Studji kliniċi juru li cetirizine fid- dożaġġ irrakkomandat kellu effetti żgħar mhux mixtieqa fuq is - CNS, li jinkludu ngħas tqil, għeja, sturdament u uġigħ ta ’ ras.
Although cetirizine is a selective antagonist of peripheral H1-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported.
Għalkemm cetirizine huwa agonist selettiv ta ’ riċetturi H1 periferali u huwa relattivament ħieles minn attivita` antikolinerġika, kienu rappurtati każi iżolati ta ’ diffikulta` biex tgħaddi l- awrina, disturb biex tiffoka l- għajn u ħalq xott.
Double blind controlled clinical or pharmacoclinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.
Provi kliniċi jew farmakokliniċi kkontrollati double- blind li jqabblu cetirizine mal - plaċebo jew mediċini oħra kontra l- istamini fid- doża rrakkomandata (10 mg kuljum għal cetirizine), fejn sar kejl ta ’ tagħrif ta ’ sigurta`, inkludew iżjed minn 3200 persuna li kienu esposti għal cetirizine.
From this pooling, the following adverse events were reported for cetirizine 10 mg in the placebo- controlled trials at rates of 1.0% or greater:
Minn dan il- grupp, l- effetti mhux mixtieqa li ġejjien kienu rrappurtati b ’ cetirizine 10 mg fi provi kkontrollati bil- plaċebo f’ rati ta ’ 1. 0% jew aktar:
34 Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases.
Għalkemm statistikament iżjed komuni minn bil- plaċebo, in- ngħas tqil kien ħafif għal moderat fil - biċċa l- kbira tal- każi.
Objective tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily dose in healthy young volunteers.
Fi studji oħra f’ voluntieri żgħar f’ saħħithom saru testijiet oġġettivi li wrew li fid- doża rrakkomandata ta ’ kuljum tas- soltu, ma kienux affetwati l- attivitajiet tas- soltu ta ’ kuljum,.
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:
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:
In addition to the adverse effects reported during clinical studies and listed above, isolated cases of the following adverse drug reactions have been reported in post-marketing experience.
Minnbarra l- effetti mhux mixtieqa li ġew irrappurtati waqt studji kliniċi li huma mniżżla hawn fuq, każi iżolati ta ’ l- effetti mhux mixtieqa li ġejjien kienu rrappurtati wara t- tqegħid fis- suq.
1/ 10,000) are made based on post-marketing experience.
Għal dawn l - effetti mhux mixtieqa li huma rappurtati anqas frekwentament, frekwenzi ta ’ l- estimi (mhux komuni: ≥1/ 1, 000 għal < 1/ 100, rari: ≥1/ 10, 000 għal < 1/ 1, 000, rari ħafna: < 1/ 10, 000) huma mfassla bbażati fuq rapporti ta ’ wara t- tqegħid fis- suq.
Uncommon: agitation Rare: aggression, confusion, depression, hallucination, insomnia Very rare: tic
Mhux komuni: aġitazzjoni Rari: aggressjoni, konfużjoni, depressjoni, alluċinazzjonijiet, insomnija, Rari ħafna: tikk
Nervous system disorders:
34 Mard tas- sistema nervuża:
Uncommon: paraesthesia Rare: convulsions, movements disorders Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia
Mhux komuni: paresteżija Rari: aċċessjonijiet, mard tal- moviment Rari ħafna: disġewsja, sinkope, rogħda, distonja, diskinesja
Rare: hepatic function abnormal (increased transaminases, alkaline phosphatase, γ -GT and bilirubin)
Rari: funzjoni tal- fwied abnormali (żieda fit- transaminases, alkaline phosphatase, γ- GT u bilirubin)
35 Skin and subcutaneous tissue disorders:
Mard tal- ġilda u t- tessut ta ’ taħt il- ġilda:
Uncommon: pruritus, rash Rare: urticaria Very rare: angioneurotic oedema, fixed drug eruption
Mhux komuni: ħakk, raxx Rari: urtikarja Rari ħafna: edema anġjonewrotika, eruzzjoni fissa għall- mediċina
General disorders and administration site conditions:
Mard ġenerali u kundizzjonijiet ta ’ mnejn jingħata:
Uncommon: asthenia, malaise Rare: oedema
Mhux komuni: astenja, telqa Rari: edima
Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect.
Is- sintomi li ġew osservati wara doża eċċessiva b ’ cetirizine huma assoċjati ma ’ effetti tas- CNS jew ma ’ effetti li jissuġġerixxu effett anti- kolinerġiku.
Adverse events reported after an intake of at least 5 times the recommended daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.
Effetti mhux mixtieqa rrappurtati wara li tittieħed qwantita` ta ’ mill- inqas 5 darbiet id- doża irrakkomandata huma: konfuzzjoni, dijareja, sturdament, għeja, uġigħ ta ’ ras, telqa kbira, mydriasis, ħakk, irrekwitazza, sedazzjoni, ngħas tqil, sturdament, takikardja, rogħda, u żamma ta ’ l- awrina.
Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1- receptors.
35 Cetirizine, prodott tal- metaboliżmu ta ’ hydroxyzine fil- bniedem, huwa antagonist qawwi u selettiv ta ’ riċetturi periferali tip H1.
In addition to its anti-H1 effect, cetirizine was shown to display anti-allergic activities: at a dose of 10 mg once or twice daily, it inhibits the late phase recruitment of eosinophils, in the skin and conjunctiva of atopic subjects submitted to allergen challenge.
Minn barra l- effett tiegħu kontra H1, instab li cetirizine għandu attivita` kontra l- allerġiji: f’ doża ta ’ 10 mg darba jew darbtejn kuljum, jinibixxi li l- eosinofili jieħdu sehem fl- aħħar fażi tal- proċess, fil - ġilda u l- kunġunktiva ta ’ persuni atopiċi li ġew sottomessi għal sfida bl- allerġen.
Studies in healthy volunteers show that cetirizine, at doses of 5 and 10 mg strongly inhibits the wheal and flare reactions induced by very high concentrations of histamine into the skin, but the correlation with efficacy is not established.
Studji f’ voluntiera f’ saħħithom juru li cetirizine f’ dożi ta ’ 5 u 10 mg jinibixxi bil- qawwa r - reazzjoniijiet tat- tip ‘ wheal and flare ’ minħabba konċentrazzjonijiet għolja ħafna ta ’ histamine fil - ġilda, iżda l- korrelazzjoni ma ’ l- effikaċja ma kienx stabbilit.
In a 35-day study in children aged 5 to 12, no tolerance to the antihistaminic effect (suppression of wheal and flare) of cetirizine was found.
Fi studju ta - 35- ġurnata fit- tfal ta ’ bejn il- 5 u t- 12- il sena, ma nstabet ebda tolleranza għall- effett ta ’ cetirizine kontra histamine (biex trażżan il - ‘ wheal and flare ’).
When a treatment with cetirizine is stopped after repeated administration, the skin recovers its normal reactivity to histamine within 3 days.
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.
In a six-week, placebo-controlled study of 186 patients with allergic rhinitis and concomitant mild to moderate asthma, cetirizine 10 mg once daily improved rhinitis symptoms and did not alter pulmonary
Fi studju ta ’ sitt ġimgħat ikkontrollat mill- plaċebo ta ’ 186 pazjent b’ rinite allerġika flimkien ma ’ ażżma ħafifa jew moderata, cetirizine 10 mg darba kuljum taffa s- sintomi tar- rinite u ma biddilx il - funzjoni tal- pulmun.
This study supports the safety of administering cetirizine to allergic patients with mild to moderate asthma.
Dan l- istudju jikkonferma s- sigurta` tat- teħid ta ’ cetirizine fil pazjenti allerġiċi b’ ażżma ħafifa jew moderata.
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.
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.
No accumulation is observed for cetirizine following daily doses of 10 mg for 10 days.
Ma deheritx akkumulazzjoni b ’ cetirizine wara dożi ta ’ 10 mg kuljum għal 10 ijiem.
The distribution of pharmacokinetic parameters such as peak plasma concentration (Cmax) and area under curve (AUC), is unimodal in human volunteers.
Id- distribuzzjoni ta ’ parametri farmakokinetiċi, bħall- ogħla konċentrazzjoni fil- plażma (Cmax) u l- arja taħt il- kurva (AUC), kienu unimodal f’ voluntiera umani.
The apparent volume of distribution is 0.50 l/ kg.
Milli jidher, il- volum ta ’ distribuzzjoni li jidher huwa ta ’ 0. 50 l/ kg.
Cetirizine does not modify the protein binding of warfarin.
Cetirizine ma jbiddilx ir- rabta tal- warfarina tal- proteini.
Cetirizine exhibits linear kinetics over the range of 5 to 60 mg.
Cetirizine għandu kinetika linejari fuq medda bejn 5 sa 60 mg.
Special populations:
Populazzjonijiet Speċjali
The half-life of cetirizine was about 6 hours in children of 6-12 years and 5 hours in children 2-6 years.
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.
In infants and toddlers aged 6 to 24 months, it is reduced to 3.1 hours.
F’ tfal żgħar u trabi ta ’ bejn is- 6- 24 il- xahar, dan kien mnaqqas għal 3. 1 sigħat.
Renally impaired patients:
36 Pazjenti b’ indeboliment tal- kliewi:
The pharmacokinetics of the drug were similar in patients with mild impairment (creatinine clearance higher than 40 ml/ min) and healthy volunteers.
Il- farmakokinetika tal- mediċina kienet simili f’ pazjenti b’ indeboliment ħafif (clearance tal- krejatinina iżjed minn 40 ml/ min) u voluntiera normali.
Patients with moderate renal impairment had a 3-fold increase in half-life and 70% decrease in clearance compared to healthy volunteers.
Pazjenti b’ indeboliment moderat tal- kliewi kellhom żieda ta ’ tliet darbiet aktar fil- half- life u tnaqqis ta ’ 70% fil- clearance meta mqabbla ma ’ voluntiera normali.
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.
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.
Dosing adjustment is necessary in patients with moderate or severe renal impairment (see section 4.2).
Hemm bżonn aġġustament fid- dożaġġ f’ pazjenti b’ indebolament moderat jew sever tal- kliewi (ara sezzjoni 4. 2).
Patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis) given 10 or 20 mg of cetirizine as a single dose had a 50% increase in half-life along with a 40% decrease in clearance compared to healthy subjects.
Pazjenti b’ mard kroniku tal- fwied (epato- cellulari, kolestatiku u ċirrożi tal- marrara) li ngħataw 10 mg jew 20 mg ta ’ cetirizine bħala doża waħda kellhom 50% żieda fil- half- life flimkien ma ’ tnaqqis ta ’ 40% tal- clearance meta mqabbla ma ’ suġġetti f’ saħħithom.
- Sodium saccharinate
- Sodium saccharinate
- Methylparahydroxybenzoate (E 218)
- Methylparahydroxybenzoate
- Propylparahydroxybenzoate (E 216)
- Propylparahydroxybenzoate
- Sodium acetate
- Sodium acetate
- Glacial acetic acid
- Glacial acetic acid
- Purified water
- Ilma purifikat
This medicinal product does not require any special storage conditions.
Dan l- prodott mediċinali m’ għandux bżonn kundizzjonijiet speċjali ta ’ ħażna.
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.
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 mit - tfal tal- polyethylene abjad.
6.7 Special precautions for disposal
37 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Zyrtec 1 mg/ ml oral solution
Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 1 mg/ ml soluzzjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari]
One ml of solution contains 1 mg cetirizine dihydrochloride
Ml wieħed ta ’ soluzzjoni fih 1 mg cetirizine dihydrochloride
- one ml of solution contains 1.35 mg methylparahydroxybenzoate
Sustanzi mhux attivi:
- one ml of solution contains 0.15 mg propylparahydroxybenzoate
- 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
Clear and colorless liquid
Likwidu car u bla kulur kemmxejn ħelu u b’ togħma ta ’ banana.
In adults and children 2 year and above:
F’ adulti u tfal ta ’ sentejn ‘ l fuq:
- Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial
- Cetirizine huwa indikat biex jittaffew sintomi nażali u tal- għajnejn ta ’ rinite allerġika tal- istaġun u
allergic rhinitis.
perenni.
Children aged from 2 to 6 years:
Tfal ta ’ bejn is- senjejn u s- 6 snin:
2.5 mg twice daily (2.5 ml oral solution twice daily (a half spoon twice daily)).
2. 5 mg darbtejn kuljum (2. 5 ml soluzzjoni orali darbtejn kuljum (nofs mgħarfa darbtejn kuljum)).
5 mg twice daily (5 ml oral solution bid (a full spoon twice daily).
5 mg darbtejn kuljum (5 ml soluzzjoni orali bid (mgħarfa sħiħa darbtejn kuljum)).
10 mg once daily (10 ml oral solution (2 full spoons)).
10 mg darba kuljum (10 ml soluzzjoni orali (2 imgħaref sħaħ)).
The solution can be swallowed as such.
Is- soluzzjoni tista ’ tittieħed kif inhi.
Patients with moderate to severe renal impairment: there are no data to document the efficacy/ safety ratio in patients with renal impairment.
Pazjenti b’ impediment renali moderat għal sever: m’ hemmx tagħrif biex juri l- proporzjon ta ’ effikaċja/ sigurta´ f’ pazjenti b’ indeboliment tal- kliewi.
Since cetirizine is mainly eliminated via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function.
Peress li cetirizine jitneħħa prinċipalment mill - kliewi (ara sezzjoni 5. 2), f’ każi fejn m’ hemmx kura alternattiva, l- intervalli ta ’ bejn doża u oħra jridu jiġu individwalizzati skond il- funzjoni renali.
Refer to the following table and adjust the dose as indicated.
Irreferi għat- tabelli li ġejja u aġġusta d- doża kif indikat.
To use this dosing table, an estimate of the patient’ s creatinine clearance (CLcr) in ml/ min is needed.
Biex tuża din it- tabella ta ’ dożaġġ, hemm bżonn li jitkejjel il- clearance tal- krejatinina tal- pazjent
40
(x 0. 85 ghan − nisa)
In pediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age and his body weight.
F’ pazjenti tfal li jbagħtu minn impediment renali, id- doża trid tiġi aġġustata fuq bażi individwali wara li jitqies il- clearance tal- kliewi, l- eta`u l- piż tal- pazjent..
Patients with hepatic impairment: no dose adjustment is needed in patients with solely hepatic impairment.
Pazjenti b’ impediment epatiku: m’ hemmx bżonn aġġustament tad- doża f’ pazjenti li għandhom biss impediment epatiku.
Patients with hepatic impairment and renal impairment: dose adjustment is recommended (see Patients with moderate to severe renal impairment above).
Pazjenti b’ indeboliment kemm tal- fwied u kemm tal- kliewi: aġġustament tad- doża huwa rrakkomandat (ara Pazjenti b’ impediment renali moderat jew sever hawn fuq).
Patients with severe renal impairment at less than 10 ml/ min creatinine clearance.
Pazjenti b’ indeboliment renali sever bi clearance tal- krejatinina ta ’ inqas minn 10 ml/ min.
Patients with rare hereditary problems of fructose intolerance should not take cetirizine 1 mg/ ml oral solution.
Pazjenti bi problem ereditarji rari ta ’ intolleranza għal fructose m’ għandhomx jieħdu cetirizine 1 mg/ ml soluzzjoni orali.
The use of the product is not recommended in children aged less than 2 years.
L- użu tal- prodott mhux rrakkomandat fit- tfal t ’ inqas minn sentejn.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
Methyl parahydroxybenzoate u propyl parahydroxybenzoate jista ’ jikkawża reazzjonijiet allerġiċi (li jistgħu jdumu ma joħorġu).
Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine.
Mhux mistennija interazzjonijiet b ’ din l- antistamina, minħabba il- profil farmakokinetiku, farmakodinamiku ta ’ tolleranza ta ’ cetirizine.
Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/ day).
40 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).
41 The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.
Il- livell t’ assorbiment ta ’ cetirizine mhux imnaqqas bl- ikel, għalkemm ir- rata ta ’ assorbiment kienet mnaqqsa.
Caution should be exercised when prescribing to pregnant or breast feeding women because cetirizine passes into breast milk.
Trid tittieħed attenzjoni meta jinkiteb għal nisa tqal jew li jkunu qed ireddgħu għaliex cetirizine jgħaddi għal ġol- ħalib ta ’ l- omm.
Objective measurements of driving ability, sleep latency and assembly line performance have not demonstrated any clinically relevant effects at the recommended dose of 10 mg.
Kejl oġġettiv tal- ħila biex ssuq, il- ħin sakemm torqod, u l- ħila f’ linja ta ’ immuntar ma wrewx effetti klinikament sinifikanti fid- doża irrakkomandata ta ’ 10 mg.
Patients intending to drive, engaging in potentially hazardous activities or operating machinery should not exceed the recommended dose and should take their response to the medicinal product into account.
Pazjenti li għandhom intenzjoni li jsuqu, li jagħmlu xi attivita` li tista ’ tkun perikoluża jew li jħaddmu magni m’ għandhomx jieħdu iżjed mid- doża irrakkomandata u għandhom iqisu r- rispons tagħhom għall- mediċina.
In some cases, paradoxical CNS stimulation has been reported.
F’ xi każi, kien irrapportat stimulazzjoni paradossali tas- CNS.
Although cetirizine is a selective antagonist of peripheral H1-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported.
Għalkemm cetirizine huwa agonist selettiv ta ’ riċetturi H1 periferali u huwa relattivament ħieles minn attivita` antikolinerġika, kienu rrappurtati każi iżolati ta ’ diffikulta` biex tgħaddi l- awrina, disturb biex tiffoka l- għajn u ħalq xott.
Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported.
Kienu rappurtati każi ta ’ funzjoni anormali tal- fwied b ’ livelli għolja ta ’ enżimi tal- fwied u bilirubin.
Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride.
Dawn ġeneralment jitjiebu meta jitwaqqaf il- kura b’ cetirizine dihydrochloride.
Double blind controlled clinical or pharmacoclinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.
Provi kliniċi jew farmakokliniċi kkontrollati double- blind jqabblu cetirizine mal - plaċebo jew mediċini oħra kontra l- istamina fid- doża rrakkomandata (10 mg kuljum għal cetirizine), fejn sar kejl ta ’ tagħrif ta ’ sigurta`, inkludew iżjed minn 3200 persuna li kienu esposti għal cetirizine.
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:
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:
Rare: hypersensitivity Very rare: anaphylactic shock
Rari: sensittivita` eċċessiva Rari ħafna: xokk anafillatiku,
Uncommon: agitation Rare: aggression, confusion, depression, hallucination, insomnia Very rare: tic
Mhux komuni:, aġitazzjoni Rari: aggressjoni, konfużjoni, depressjoni, alluċinazzjonijiet, insomnja Rari ħafna: tikk
Nervous system disorders:
42 Mard tas- sistema nervuża:
43 Rare: convulsions, movements disorders Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia
Mhux komuni: paresteżija Rari: aċċessjonijiet, mard tal- moviment Rari ħafna: disġewsja, sinkope,, rogħda, distonja, diskinesja
Uncommon: pruritus, rash Rare: urticaria Very rare: angioneurotic oedema, fixed drug eruption
Mhux Komuni: ħakk, raxx Rari: urtikarja Rari ħafna: edema anġjonewrotika, eruzzjoni fissa għall- mediċina
Adverse events reported after an intake of at least 5 times the recommended daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.
Effetti mhux mixtieqa rrappurtati wara li tittieħed qwantita` ta ’ mill- inqas 5 darbiet id- doża irrakkomandata huma: konfużjoni, dijareja, sturdament, għeja, uġigħ ta ’ ras, telqa, mydriasis, ħakk, irrekwitezza, sedazzjoni, ngħas tqil, sturdament, takikardja, rogħda, u żamma ta ’ l- awrina.
Gastric lavage should be considered following ingestion of a short occurrence.
Għandu jiġi kkunsidrat il- ħasil ta ’ l- istonku jekk ma jkunx ilu li ttieħdet mill- ħalq.
44 Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1- receptors.
43 Cetirizine, prodott tal- metaboliżmu ta ’ hydroxyzine fil- bniedem, huwa antagonist b’ saħħtu u selettiv ta ’ riċetturi periferali tip H1.
In vitro receptor binding studies have shown no measurable affinity for other than H1- receptors.
Studji in vitro fuq ir- rabta mar- riċetturi ma wrew ebda affinita` għal riċetturi ħlief dawk H1
In addition to its anti-H1 effect, cetirizine was shown to display anti-allergic activities: at a dose of 10 mg once or twice daily, it inhibits the late phase recruitment of eosinophils, in the skin and conjunctiva of atopic subjects submitted to allergen challenge.
Minn barra l- effett tiegħu kontra H1, instab li cetirizine għandu attivita` kontra l- allerġiji: f’ doża ta ’ 10 mg darba jew darbtejn kuljum, li l- eosinofili jieħdu sehem fl- aħħar fażi tal- proċess, fil- ġilda u l - kunġunktiva ta ’ persuni atopiċi li ġew sottomessi għal sfida bl- allerġen.
In a 35-day study in children aged 5 to 12, no tolerance to the antihistaminic effect (suppression of wheal and flare) of cetirizine was found.
Studji f’ voluntiera f’ saħħithom juru li cetirizine f’ dożi ta ’ 5 u 10 mg jinibixxi bil- qawwa r - reazzjoniijiet tat- tip ‘ wheal and flare ’ minħabba b’ konċentrazzjonijiet għolja ħafna ta ’ l- istamina fil - ġilda, imma il- korrelazzjoni ma ġietx stabbilita Fi studju ta - 35- ġurnata fit- tfal ta ’ bejn il- 5 u t- 12- il sena, ma nstabet ebda tolleranza għall- effett ta ’ cetirizine kontra l- istamina (biex trażżan il - ‘ wheal and flare ’).
This study supports the safety of administering cetirizine to allergic patients with mild to moderate asthma.
Dan l- istudju jikkonferma s- sigurta` tat- teħid ta ’ cetirizine lil pazjenti allerġiċi b’ ażżma ħafifa jew moderata.
The distribution of pharmacokinetic parameters such as peak plasma concentration (Cmax) and area under curve (AUC), is unimodal in human volunteers.
Id- distribuzzjoni ta ’ parametri farmakokinetiċi, bħall- ogħla konċentrazzjoni fil- plażma (Cmax) u l- erja taħt il- kurva (AUC), kienu unimodal f’ voluntiera umani.
Special populations
Populazzjonijiet Speċjali
The decrease in cetirizine clearance in these elderly volunteers appeared to be related to their decreased renal function.
It- tnaqqis fil- clearance ta ’ cetirizine f’ dawn il- voluntiera anzjani deher li kien relatat mat- tnaqqis fil- funzjoni rli kellhom tal - kliewi.
In infants and toddlers aged 6 to 24 months, it is reduced to 3.1 hours.
F’ tfal żgħar u trabi ta ’ bejn is- 6 u l- 24 xahar, dan kien mnaqqas għal 3. 1 sigħat.
Renally impaired patients:
44 Pazjenti b’ indeboliment tal- kliewi:
Patients with
Il- farmakokinetika tal- mediċina kienet simili f’ pazjenti b’ indeboliment ħafif (clearance tal- krejatinina iżjed minn 40 ml/ min) u voluntiera f’ saħħithom.
45 moderate renal impairment had a 3-fold increase in half-life and 70% decrease in clearance compared to healthy volunteers.
Pazjenti b’ indeboliment moderat tal- kliewi kellhom żieda ta ’ tliet darbiet aktar fil- half- life u tnaqqis ta ’ 70% fil- clearance meta mqabbla ma ’ voluntiera f’ saħħithom.
Dosing adjustment is necessary in patients with moderate or severe renal impairment (see section 4.2).
Hemm bżonn aġġustament fid - dożaġġ f’ pazjenti b’ indeboliment moderat jew sever tal- kliewi( ara sezzjoni 4. 2).
- Sorbitol solution at 70% (non crystallizing) (E420)
- soluzzjoni ta’ sorbitol ta ’ 70% (li ma tikkristillax)
- Banana flavor 54.330/ A (Firmenich)
- Togħma ta ’ banana 54. 330/ A (Firmenich)
This medicinal product does not require any special storage conditions
Dan l- prodott mediċinali m’ għandux bżonn kundizzjonijiet ta ’ ħażna.
Amber glass bottle (type III) of 60, 75, 100, 125, 150, or 200 ml, closed with a white polypropylene child-resistant closure.
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.