natgillin/translations-raw huggingface dataset:
Dosing adjustment is only necessary in hepatically impaired patients if concomitant renal impairment is present.
Prilagajanje odmerka je potrebno samo pri tistih bolnikih z jetrno okvaro, ki imajo hkrati prisotno tudi ledvično okvaro.
Oral solution Bottle of 60 ml Bottle of 75 ml Bottle of 100 ml Bottle of 125 ml Bottle of 150 ml Bottle of 200 ml
Peroralna raztopina Steklenička 60 ml Steklenička 75 ml Steklenička 100 ml Steklenička 125 ml Steklenička 150 ml Steklenička 200 ml
The MAH was also asked to justify the dosing in paediatric patients suffering from renal impairment and the dosing by weight in the 2-5 year age group and dosing by age groups 2-5, 6-11 and 12-18 as well as dosing for children less than 2 years old.
Imetnik dovoljenja za promet z zdravilom je bil tudi naprošen, da obrazloži odmerjanje pri pediatričnih bolnikih z ledvičnimi obolenji, pri odmerjanju zdravila na podlagi telesne mase pri starostni skupini od 2 do5 let ter odmerjanje pri starostnih skupinah od 2-5, 6-11 in 12-18 let kakor tudi pri otrocih, mlajših od 2 let.
The MAH stated that the clinical benefit/risk ratio of cetirizine has not been specifically evaluated in patients with renal impairment and that the dose is therefore based on pharmacokinetic calculations only.
Imetnik dovoljenja za promet z zdravilom je navedel, da klinično razmerje med koristmi in tveganji cetirizina ni bilo posebej ovrednoteno pri bolnikih z ledvičnimi obolenji in da so zato odmerki določeni samo na podlagi farmakokinetičnih izračunov.
Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache.
Klinične študije so pokazale, da cetirizin pri jemanju priporočenih odmerkov povzroča manj pomembne neželene učinke na centralni živčni sistem, na primer somnolenco, utrujenost, omotico in glavobol.
The doses proposed for registration have been demonstrated as being safe and effective in many trials performed in children 2 to 12 years old, as reviewed in the clinical expert report provided in the MAH dossier.
Več študij, izvedenih pri otrocih, starih od 2 do 12 let, je pokazalo, da so odmerki, predlagani za registracijo, varni in učinkoviti, kar je razvidno tudi iz strokovnega kliničnega poročila, ki ga je imetnik dovoljenja za promet z zdravilom predložil v dokumentaciji.
The Product Information of the tablet and the oral formulations also reflected the additional contraindication related to the excipients.
Informacije o zdravilu pri tabletah in peroralnih pripravkih odražajo tudi dodatno kontraindikacijo v zvezi s pomožnimi snovmi.
The posology proposed for children has been tested in clinical trials, but also results from dosing adaptations based on body weight and clearance that varies according to the maturation of the renal system.
Predlagano odmerjanje za otroke je bilo preverjeno v kliničnih preskušanjih, izhaja pa tudi iz prilagajanja odmerkov telesni masi in izločanju zdravila, kar je odvisno od zrelosti ledvičnega sistema.
United Kingdom: Benadryl one a day, Benadryl one a day relief, Zirtek allergy relief tablets
Švedska: Zyrlex Velika Britanija: Benadryl one a day, Benadryl one a day relief, Zirtek allergy relief tablets
Caution in epileptic patients and patients at risk of convulsions is recommended.
Pri bolnikih z epilepsijo in pri bolnikih s povečanim tveganjem za nastanek krčev, se priporoča previdnost.
If you think you have any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
The CHMP agreed that no safety or toxicity issues with the use of cetirizine in renal failure have been identified over the many years of clinical experience; however the CHMP adopted a lower age limit of 2 years for the use of cetirizine.
CHMP je soglašal, da se v več letih klinične uporabe cetirizina pri odpovedi ledvic niso pokazale nobene težave glede varnosti ali toksičnosti, vendar pa je sprejel nižjo starostno omejitev 2 let za uporabo cetirizina.
The CHMP asked the MAH to revise the wording, restrict and define the indication in rhinoconjunctivitis rather than in conjunctivitis alone and discuss seasonal conjunctivitis, itching and allergic pruritis, severe skin reactions induced by mosquito and atopic dermatitis, as they should be considered as separate entities requiring more supportive data.
CHMP je zaprosil imetnika dovoljenja za promet z zdravilom za ponovni pregled besedila ter omejitev in natančno opredelitev indikacije pri rinokonjunktivitisu, namesto samo pri konjunktivitisu, ter preučitev indikacij sezonski konjunktivitis, srbenje in alergijski pruritis, hude kožne spremembe zaradi pikov komarjev ali atopični dermatitis, ker jih je treba obravnavati kot posamezne primere, ki zahtevajo več podpornih podatkov.
Renally impaired patients: The pharmacokinetics of the drug were similar in patients with mild impairment (creatinine clearance higher than 40 ml/min) and healthy volunteers.
Farmakokinetika zdravila je bila pri bolnikih z blago ledvično okvaro (očistek kreatinina večji od 40 ml/min) in zdravih prostovoljcih podobna.
Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect.
Simptomi, ki so jih opazili pri prevelikem odmerjanju cetirizina, so v glavnem povezani z učinki na centralni živčni sistem ali antiholinergičnimi učinki.
No signal suggesting an unfavourable benefit/risk ratio for Zyrtec compared to other antihistamines was ever detected in pharmacovigilance during the 22 years on the market; however the MAH would like to retain the contraindication: “Patients with severe renal impairment at less than 10 ml/min creatinine clearance.”
Prav tako se v zadnjih 22 letih, ko je zdravilo na tržišču, v farmakovigilanci ni pokazal noben znak, ki bi nakazoval neustrezno razmerje med koristmi in tveganji zdravila Zyrtec v primerjavi z drugimi antihistaminiki; kljub temu pa imetnik dovoljenja za promet z zdravilom želi obdržati kontraindikacijo: „Bolniki s hudimi ledvičnimi obolenji z manj kot 10 ml/min izločanja kreatinina.“
The MAH argued that the paediatric use of cetirizine in the same indications as in adults is justified, as no pathophysiological reason was identified for not using antihistamines in the paediatric population, provided the dose is adequately adapted to different body weight, age and clearance of the drug.
Imetnik dovoljenja za promet z zdravilom je trdil, da je uporaba cetirizina pri otrocih pri istih indikacijah kot pri odraslih utemeljena, saj ne obstajajo nobeni patofiziološki razlogi, ki bi utemeljevali neuporabo antihistaminikov pri pediatrični populaciji, če je odmerek ustrezno prilagojen različni telesni masi, starosti in izločanju zdravila.
Patients with hepatic impairment: no dose adjustment is needed in patients with solely hepatic impairment.
Bolniki z jetrno okvaro: odmerka ni potrebno prilagoditi za bolnike, ki imajo samo jetrno okvaro.
Pack with a bottle of 10, 15, 20, or 30 ml solution.
Pakiranje s stekleničko po 10, 15, 20 ali 30 ml raztopine.
For children with renal impairment, the clinical effects or the pharmacokinetics of cetirizine have never been tested but the MAH agreed that the current wording is not entirely correct since the age of the patient is important as it determines its clearance.
Klinični učinki ali farmakokinetika cetirizina pri otrocih z ledvičnimi obolenji niso bili nikoli preverjeni, se pa imetnik dovoljenja za promet z zdravilom strinja, da sedanje besedilo ni popolnoma pravilno, ker je starost bolnikov pri odmerjanju pomembna, saj vpliva na izločanje.
The MAH agreed with the CHMP recomendations but considered that the sentence on food interaction should be retained as it is independent from the liver enzymes interactions.
Imetnik dovoljenja za promet z zdravilom se je strinjal s priporočili CHMP, vendar menil, da stavek o medsebojnem delovanju s hrano ni potreben, saj to ni odvisno od medsebojnega delovanja z jetrnimi encimi.
Tablets need to be swallowed with a glass of liquid.
Tablete naj bolnik pogoltne s kozarcem tekočine.
McNeil Products Limited Walton Oaks, Dorking Road, Walton on the Hill, Surrey KT20 7NS UK
McNeil Products Limited Walton Oaks, Dorking Road, Walton on the Hill, Surrey KT20 7NS, Velika Britanija
One film-coated tablet contains
Ena filmsko obložena tableta vsebuje
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
Metilparahidroksibenzoat in propilparahidroksibenzoat lahko povzročita alergijske reakcije (lahko zapoznele).
These guidelines apply unless your doctor has given you different instructions on how to use Zyrtec.
Upoštevajte ta navodila, razen če vam je zdravnik dal drugačna navodila, kako jemati zdravilo Zyrtec.
These guidelines apply unless your Doctor has given you different instructions on how to use Zyrtec.
Upoštevajte ta navodila, razen, če vam je zdravnik dal drugačna navodila, kako jemati zdravilo Zyrtec.
Dosing adjustment is necessary in patients with moderate or severe renal impairment (see section 4.2).
Pri bolnikih z zmerno ali hudo ledvično okvaro je potrebno prilagajanje odmerka (glejte poglavje 4.2).
Investigations: Rare: weight increased
Preiskave: Redki: povečana telesna masa
DATE OF REVISION OF THE TEXT [To be completed nationally]
DATUM ZADNJE REVIZIJE BESEDILA [Dopolniti lokalno]
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.
V šesttedenski s placebom nadzorovani študiji, v katero je bilo vključenih 186 bolnikov z alergijskim rinitisom in sočasno blago do zmerno astmo, je cetirizin 10 mg enkrat na dan izboljšal simptome rinitisa in ni spremenil pljučne funkcije.
Very rare: angioneurotic oedema, fixed drug eruption
Zelo redki: angionevrotičen edem, z zdravilom povezane kožne erupcije
Regarding the dosing by weight, the MAH responded that systemic exposure to cetirizine is not only a function of body weight but also of renal clearance of the drug, with studies demonstrating that clearance is more important when age is low.
V zvezi z odmerjanjem na podlagi telesne mase je imetnik dovoljenja za promet z zdravilom odgovoril, da sistemska izpostavljenost cetirizinu ne more temeljiti le na sami telesni masi, ampak tudi na ledvičnem izločanju zdravila, saj študije kažejo, da je pri nizki starosti izločanje pomembnejše.
Like all medicines, Zyrtec can cause side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi zdravilo Zyrtec neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Elderly subjects: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.
Podatki ne kažejo, da bi bilo treba odmerek zmanjšati pri starejših, če je njihovo delovanje ledvic normalno.
You should not take Zyrtec 1 mg/ml oral solution: - if you have rare hereditary problems of fructose intolerance
Zdravila Zyrtec 1 mg/ml peroralne raztopine ne smete jemati: - če imate redko dedno intoleranco za fruktozo.
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.
Objektivna merjenja sposobnosti vožnje, nagnjenosti k zaspanosti in storilnosti za tekočim trakom pri priporočenem odmerku 10 mg niso pokazala klinično pomembnih učinkov.
White, oblong, film-coated tablet, with breakline and Y-Y logo
Bela, podolgovata, filmsko obložena tableta, z razdelilno zarezo in Y-Y oznako.
Film-coated tablets 1 tablet
Filmsko obložene tablete 1 tableta
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.
Cetirizin ima poleg svojega antihistaminskega delovanja tudi protialergijski učinek: pri odmerku 10 mg enkrat ali dvakrat na dan zavira pozno fazo zbiranja eozinofilcev, v koži in očesni veznici atopičnih subjektov, podvrženih alergenom.
Pack with a bottle of 60, 75, 100, 125, 150, or 200 mL solution.
Pakiranje s stekleničko po 60, 75, 100, 125, 150 ali 200 ml raztopine.
A 5ml Dosing spoon with a line at 2.5 ml is provided with the bottle.
5 ml merilna žlička z oznako pri 2,5 ml je priložena steklenički.
- Body as a whole: common: fatigue
- Splošne težave: pogosti: utrujenost.
Children between 6 and 12 years old:
Otroci, stari od 6 do 12 let:
At the first signs of a hypersensitivity reaction, stop taking Zyrtec.
Ob prvih znakih preobčutljivostne reakcije prenehajte z jemanjem zdravila Zyrtec.
Boxes of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, or 100 tablets.
Škatle z 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, ali 100 tabletami.
Children, infants and toddlers: The half-life of cetirizine was about 6 hours in children of 6-12 years and 5 hours in children 2-6 years.
Razpolovna doba cetirizina je bila pri otrocih, starih od 6 do 12 let, okoli 6 ur, pri otrocih, starih od 2 do 6 let, pa 5 ur.
Due to the profile of cetirizine, no interactions with other drugs are expected.
Glede na lastnosti cetirizina ni pričakovati medsebojnega delovanja z drugimi zdravili.
- 10 ml Zyrtec oral solution (=2 measuring spoons) contain: 3.15 g glucose equivalents (sorbitol).
2 merilni žlički) vsebuje: 3,15 g ekvivalenta glukoze (sorbitol).
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.
Če kapljice razredčimo, je treba upoštevati, še posebej pri otrocih, količino vode, v kateri razredčimo kapljice.
France: Reactine, Virlix, Cetirizine UCB 10mg, Zyrtec, Actifed Allergie cetirizine 10mg, Zyrtecset Germany: Zyrtec, Zyrtec P, Reactine
Francija: Reactine, Virlix, Cetirizine UCB 10mg, Zyrtec, Actifed Allergie cetirizine 10mg, Zyrtecset Nemčija: Zyrtec, Zyrtec P, Reactine
Slovenia: Zyrtec10 mg filmsko oblozene tablete
Slovenija: Zyrtec10 mg filmsko oblozene tablete
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.
Steklenička jantarne barve (tip III) z 10, 15, 20 ali 30 ml raztopine s kapalko iz belega polietilena majhne gostote, zaprta z za otroke varno polipropilensko zaporko.
Do not use Zyrtec after the expiry date which is stated on the box and blister.
Zdravila Zyrtec ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
The MAH proposed a harmonised text for section 4.4 Special Warnings, as the section was extensively disharmonised and added some warnings regarding the suitability of the formulations for certain age ranges and reflecting the lack of appropriate data on the benefit- risk for children below one year old, restricting the use of film-coated tablets in children aged less than 6 years, the use of the oral solution children aged less than 2 years and the use of the drop formulation in infants and toddlers aged less than 1 year old.
Posebna opozorila, saj se je razdelek v tem delu precej razhajal, dodana pa so bila tudi posebna opozorila o primernosti oblik pripravkov za določene starostne skupine in, glede na pomanjkanje ustreznih podatkov o razmerju med koristmi in tveganji pri otrocih, mlajših od enega leta, omejevanju uporabe filmsko obloženih tablet pri otrocih, mlajših od 6 let, peroralne raztopine pri otrocih, mlajših od 2 let, ter kapljičnih pripravkov pri dojenčkih in mlajših otrocih, starih manj kot 1 leto.
Regarding dosage under the age of 2, the MAH justified the dosing based on PK data.
Kar zadeva odmerjanje pri starostni skupini do 2 let, je imetnik dovoljenja za promet zagovarjal odmerjanje na podlagi farmakokinetičnih podatkov.
You should not take Zyrtec 10 mg tablets: - if you have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Zdravila Zyrtec 10 mg tablete ne smete jemati: - če imate dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze.
Slovenia: Zyrtec1 mg/ml peroralna raztopina
Slovenija: Zyrtec1 mg/ml peroralna raztopina
If you develop one of the side effects described above, please inform your doctor.
Če opazite katerikoli zgoraj navedeni neželeni učinek, obvestite svojega zdravnika.
Cetirizine is not effectively removed by dialysis.
Z dializo cetirizina ne odstranimo učinkovito.
Zyrtec is an antiallergic medication.
Zdravilo Zyrtec je zdravilo proti alergiji.
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:
Pri 1 % ali več otrok, starih od 6 mesecev do 12 let, ki so bili vključeni v s placebom nadzorovana klinična in farmakoklinična preskušanja, so se pojavili naslednji neželeni učinki:
Spain: Alerlisin, Virlix, Reactine 5mg/5ml solución oral, Zyrtec solución oral Sweden: Zyrlex
Španija: Alerlisin, Virlix, Reactine 5mg/5ml solución oral, Zyrtec solución oral Švedska: Zyrlex
INSTRUCTIONS ON USE [To be completed nationally]
NAVODILA ZA UPORABO [Dopolniti lokalno]
Austria: Zyrtec 10 mg -Filmtabletten
Avstrija: Zyrtec 10 mg - Filmtabletten
If you are intending to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose.
V primeru, da nameravate voziti, se ukvarjati s potencialno nevarnimi aktivnostmi ali upravljati s stroji, ne smete preseči priporočenega odmerka in morate pozorno opazovati svoj odziv na zdravilo.
Patients with severe renal impairment at less than 10 ml/min creatinine clearance.
Bolniki s hudo ledvično okvaro z očistkom kreatinina manj kot 10 ml/min.
Do not take Zyrtec - if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min); - if you are known to be hypersensitive to the active substance of Zyrtec, to any of its excipients (other constituents), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines).
Ne jemljite zdravila Zyrtec - Če imate hudo ledvično bolezen (huda ledvična odpoved s kreatininskim očistkom manjšim od 10 ml/min); - Če ste alergični na (preobčutljivi za) zdravilno učinkovino zdravila Zyrtec, katerokoli pomožno snov (druge sestavine zdravila), hidroksizin ali derivate piperazina (blizu sorodne zdravilne učinkovine drugih zdravil)
UCB Pharma SA (Brussels) Allée de la Recherche, 60
UCB Pharma SA (Bruselj) Allée de la Recherche, 60 B-1070
As with other drugs, use of Zyrtec should be avoided in pregnant women.
Uporabi zdravila Zyrtec pri nosečnicah se je treba izogibati.
Cetirizine was poorly cleared by haemodialysis.
Cetirizin se je s hemodializo slabo izločil.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Pack with 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, or 100 tablets.
Pakiranje z 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90 ali 100 tabletami.
In these sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.
Pri občutljivih bolnikih lahko sočasna uporaba alkohola in drugih pomirjeval dodatno zmanjša zbranost in poslabša delovno storilnost.
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.
Čeprav je cetirizin selektivni antagonist perifernih receptorjev H1 in nima antiholinergičnega delovanja, so poročali o posameznih primerih motenj mokrenja, motenj akomodacije očesa in pojava suhih ust.
If you take more Zyrtec than you should If you think you have taken an overdose of Zyrtec please inform your doctor.
Če ste vzeli večji odmerek zdravila Zyrtec, kot bi smeli Če mislite, da ste vzeli prevelik odmerek zdravila Zyrtec, obvestite svojega zdravnika.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take cetirizine film-coated tablet.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride.
V glavnem so težave odpravljene s prenehanjem jemanja cetirizinejevega diklorida..
- You must contact a doctor if your symptoms worsen or do not improve after 3 days.
- Če se znaki vaše bolezni poslabšajo ali ne izboljšajo v treh dneh, se posvetujte z zdravnikom.
Italy: Formistin, Virlix, Zirtec 10 mg compresse rivestite con film Latvia: Zyrtec
Italija: Formistin, Virlix, Zirtec 10 mg compresse rivestite con film Latvija: Zyrtec
From this pooling, the following adverse events were reported for cetirizine 10 mg in the placebocontrolled trials at rates of 1.0 % or greater:
Iz zbira podatkov v s placebom nadzorovanih preskušanjih so ugotovili, da so se pri uporabi 10 mg cetirizina pojavili naslednji neželeni dogodki pri 1,0 % ali več bolnikov:
If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
Če imate epilepsijo ali če pri vas obstaja povečano tveganje za nastanek krčev, se posvetujte s svojim zdravnikom.
In some cases, paradoxical CNS stimulation has been reported.
V nekaterih primerih so poročali o presenetljivi stimulaciji centralnega živčnega sistema.
At the recommended dosage, cetirizine has demonstrated that it improves the quality of life of patients with perennial and seasonal allergic rhinitis.
Ugotovili so, da cetirizin v priporočenih odmerkih izboljša kakovost življenja bolnikom s celoletnim in sezonskim alergijskim rinitisom.
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet,
- da je bila podlaga napotitve uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo;
Hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to any piperazine derivatives.
Preobčutljivost za hidroksizin ali katerikoli derivat piperazina.
Important information about some of the ingredients of Zyrtec Zyrtec film-coated tablets contain lactose; if you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.
Pomembne informacije o nekaterih sestavinah zdravila Zyrtec Zyrtec filmsko obložene tablete vsebujejo laktozo; če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
The use of the product is not recommended in children aged less than 2 years.
Pri otrocih, mlajših od 2 let, uporaba tega zdravila ni priporočljiva.
Slovak Republic: Zyrtec tbl flm 10mg
Slovaška: Zyrtec tbl flm 10mg
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.
Po zaužitju najmanj petkratnega priporočenega odmerka dnevno poročajo o pojavu sledečih neželenih učinkov: zmedenost, diareja, omotica, utrujenost, glavobol, slabo počutje, midriaza, pruritus, nemir, sedacija, somnolenca, stupor, tahikardija, tremor in retencija urina.