natgillin/translations-raw huggingface dataset:
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.
3 Desloratadina iz telesa ni mogoče odstraniti s hemodializo in ni znano, ali se lahko odstrani s peritonealno dializo.
Neoclarityn given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
V kliničnih preskušanjih zdravilo Neoclarityn v enem dnevnem odmerku 7, 5 mg ni vplivalo na psihomotorične sposobnosti bolnikov.
In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced impairment in performance or increase in sleepiness.
V kliničnih farmakoloških preskušanjih sočasna uporaba zdravila Neoclarityn z alkoholom ni okrepila škodljivega vpliva alkohola na psihomotorične sposobnosti ali povečala zaspanosti pri bolnikih.
Neoclarityn effectively controlled symptoms for 24 hours.
Neoclarityn učinkovito obvladuje te simptome za čas 24 ur.
The efficacy of Neoclarityn tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Učinkovitosti zdravila Neoclarityn tablete niso jasno dokazali v preskušanjih pri mladostnikih, starih od 12 do 17 let.
The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.
Neoclarityn je učinkovito ublažil težave, povezane s sezonskim alergijskim rinitisom, kar so pokazali skupni rezultati vprašalnika o kakovosti življenja bolnikov z rinitisom in konjunktivitisom Največje izboljšanje so ugotavljali v zvezi s praktičnimi problemi in pri dnevnih dejavnostih, ki jih sicer ovirajo simptomi te bolezni.
4 In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
V dveh s placebom kontroliranih šesttedenskih preskušanjih pri bolnikih s kronično idiopatsko urtikarijo je Neoclarityn učinkovito blažil srbenje in zmanjšal velikost in število izpuščajev koprivnice že do konca prvega intervala odmerjanja.
Treatment with Neoclarityn also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Zdravljenje z zdravilom Neoclarityn je tudi bistveno zmanjšalo motnje spanja in dnevnih dejavnosti bolnika čez dan, kar so ugotavljali na podlagi meritev s štiritočkovno lestvico za oceno teh spremenljivk.
Neoclarityn is supplied in unit dose blisters comprised of laminant blister film with foil lidding.
Neoclarityn je na voljo v laminatnih pretisnih omotih za enojni odmerek, ki ga sestavljata film pretisnega, omota in folija, ki ga prekriva.
Neoclarityn may be taken without regard to mealtime for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
Zdravilo Neoclarityn lahko bolnik jemlje ne glede na obroke za lajšanje simptomov, povezanih z alergijskim rinitisom (vključno z intermitentnim in perzistentnim alergijskim rinitisom) in za zdravljenje urtikarije (glejte poglavje 5. 1).
The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin (see section 4.4) and there are no data supporting the treatment of infectious rhinitis with Neoclarityn.
Zdravnik, ki predpiše zdravilo, naj se zaveda, da je pri otrocih, mlajših od 2 let, večina primerov rinitisa infekcijskega izvora (glejte poglavje 4. 4) in da ni nobenih podatkov, ki bi govorili v prid zdravljenju infekcijskega rinitisa z zdravilom Neoclarityn.
2.5 ml (1.25 mg) Neoclarityn syrup once a day.
2, 5 ml (1, 25 mg) sirupa Neoclarityn enkrat na dan.
5 ml (2.5 mg) Neoclarityn syrup once a day.
5 ml (2, 5 mg) sirupa Neoclarityn enkrat na dan.
10 ml (5 mg) Neoclarityn syrup once a day.
10 ml (5 mg) sirupa Neoclarityn enkrat na dan.
Efficacy and safety of Neoclarityn syrup in children under 1 year of age have not been established.
Pri otrocih, mlajših od 1 leta, še niso ugotovili učinkovitosti in varnosti Neoclarityn sirupa.
The effects of Neoclarityn syrup in poor metabolisers < 2 years of age have not been studied.
Učinkov zdravila Neoclarityn sirup pri otrocih, mlajših od 2 let, ki slabo presnavljajo zdravilo, niso raziskovali.
No clinically relevant interactions were observed in clinical trials with Neoclarityn tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
V kliničnih preskušanjih tablet Neoclarityn, v katerih so bolniki sočasno jemali tudi eritromicin ali ketokonazol, niso opažali nobenih klinično pomembnih interakcij med zdravili (glejte poglavje 5. 1).
In a clinical pharmacology trial, Neoclarityn tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
(glejte poglavje 5. 1).
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in breastfeeding women.
Desloratadin se izloča v materino mleko, zato ne priporočamo uporabe zdravila Neoclarityn pri doječih materah.
In clinical trials in a paediatric population, Neoclarityn syrup was administered to a total of 246 children aged 6 months through 11 years.
V kliničnih preskušanjih pri pediatrični populaciji so zdravilo Neoclarityn sirup dajali skupaj 246 otrokom, starim od 6 mesecev do 11 let.
The overall incidence of adverse events in children 2 through 11 years of age was similar for the Neoclarityn syrup and the placebo groups.
Skupna incidenca neželenih učinkov pri otrocih, starih od 2 do 11 let, ki so prejemali zdravilo Neoclarityn, je bila podobna skupni incidenci pri skupini, ki je prejemala placebo.
At the recommended dose, in clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic idiopathic urticaria, undesirable effects with Neoclarityn were reported in 3% of patients in excess of those treated with placebo.
V kliničnih preskušanjih pri različnih indikacijah za uporabo zdravila, vključno z alergijskim rinitisom in kronično idiopatsko urtikarijo, so pri priporočenem odmerku na dan o neželenih učinkih zdravila Neoclarityn poročali pri 3% bolnikov več kot pri tistih, ki so bili zdravljeni s placebom.
Cardiac disorders Gastrointestinal disorders
Omotica, zaspanost, nespečnost, psihomotorična Bolezni živčevja hiperaktivnost, epileptični napadi
Efficacy of Neoclarityn syrup has not been investigated in separate paediatric trials.
Učinkovitosti zdravila Neoclarityn sirup niso raziskovali v ločenih pediatričnih preskušanjih.
Safety of Neoclarityn syrup was demonstrated in three paediatric trials.
V treh preskušanjih pri pediatričnih bolnikih so dokazali varnost zdravila Neoclarityn sirup.
Neoclarityn tablets given at a single daily dose of 7.5 mg to adults and adolescents did not affect psychomotor performance in clinical trials.
V kliničnih preskušanjih zdravilo Neoclarityn pri enkratnem dnevnem odmerku 7, 5 mg pri odraslih in mladostnikih ni vplivalo na psihofizične sposobnosti bolnikov.
In clinical pharmacology trials in adults, co-administration with alcohol did not increase the alcohol- induced impairment in performance or increase in sleepiness.
V kliničnih farmakoloških preskušanjih pri odraslih sočasna uporaba zdravila Neoclarityn z alkoholom ni okrepila škodljivega vpliva alkohola na psihomotorične sposobnosti ali povečala zaspanosti pri bolnikih.
Efficacy of Neoclarityn syrup has not been investigated in paediatric trials in children less than 12 years of age.
Učinkovitosti zdravila Neoclarityn sirup niso proučili v pediatričnih preskušanjih pri otrocih, mlajših od 12 let.
Neoclarityn tablets were effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Neoclarityn tablete so učinkovito ublažile težave, povezane s sezonskim alergijskim rinitisom, kar je pokazal skupni rezultat vprašalnika o kakovosti življenja bolnikov z rinitisom in konjunktivitisom.
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
V dveh s placebom kontroliranih šesttedenskih preskušanjih pri bolnikih s kronično idiopatsko urtikarijo je Neoclarityn učinkovito blažil srbenje in zmanjšal velikost in število izpuščajev koprivnice že do konca prvega intervala odmerjanja.
Treatment with Neoclarityn also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Zdravljenje z zdravilom Neoclarityn je tudi bistveno zmanjšalo motnje spanja in dnevnih dejavnosti, kar so ugotavljali na podlagi meritev s štiritočkovno lestvico za oceno teh spremenljivk.
The effects of Neoclarityn syrup in poor metabolizers < 2 years of age have not been studied.
Učinkov zdravila Neoclarityn sirup pri bolnikih, mlajših od 2 let, ki slabo presnavljajo zdravilo, niso raziskovali.
Neoclarityn syrup is supplied in bottles of 30, 50, 60, 100, 120, 150, 225, and 300 ml in type III amber glass bottles closed with a childproof polypropylene cap.
Neoclarityn sirup je na voljo v stekleničkah po 30, 50, 60, 100, 120, 150, 225 in 300 ml iz rjavega stekla tipa III, zaprtih z za otroke varno polipropilensko zaporko.
Neoclarityn 5 mg oral lyophilisate
Neoclarityn 5 mg peroralni liofilizat
Each dose of Neoclarityn oral lyophilisate contains 5 mg desloratadine.
Vsak odmerek zdravila Neoclarityn peroralni liofilizat vsebuje 5 mg desloratadina.
Adults and adolescents (12 years of age and over): one dose of Neoclarityn oral lyophilisate placed in the mouth once a day for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
Odrasli in mladostniki (stari 12 let ali več): bolnik naj si da en odmerek zdravila Neoclarityn peroralni liofilizat v usta enkrat na dan za lajšanje simptomov, povezanih z alergijskim rinitisom (vključno z intermitentnim in perzistentnim alergijskim rinitisom) in za zdravljenje urtikarije (glejte poglavje 5. 1).
Neoclarityn oral lyophilisate disperses instantly and water or other liquid is not needed.
Neoclarityn peroralni liofilizat se v ustih dispergira v trenutku in ni potrebno pitje vode ali drugih tekočin.
In the case of severe renal insufficiency, Neoclarityn should be used with caution.
V primeru hude ledvične insuficience morate zdravilo Neoclarityn uporabljati previdno.
No clinically relevant interactions were observed in clinical trials with Neoclarityn tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
V kliničnih preskušanjih, v katerih so bolniki sočasno s tabletami Neoclarityn jemali tudi eritromicin ali ketokonazol, niso opažali klinično pomembnih interakcij med zdravili (glejte poglavje 5. 1).
In a clinical pharmacology trial, Neoclarityn tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
V klinični farmakološki raziskavi pri sočasnem jemanju tablet Neoclarityn in uživanju alkohola ni bilo okrepljenih škodljivih učinkov alkohola (glejte poglavje 5. 1).
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Neoclarityn tablets were reported in 3% of patients in excess of those treated with placebo.
V kliničnih preskušanjih pri nizu indikacij za uporabo zdravila, vključno z alergijskim rinitisom in kronično idiopatsko urtikarijo, so pri priporočenem odmerku 5 mg na dan o neželenih učinkih tablet Neoclarityn poročali pri 3% bolnikov več kot pri tistih, ki so bili zdravljeni s placebom.
Hepatobiliary disorders
Omotica, zaspanost, nespečnost, psihomotorična Bolezni živčevja hiperaktivnost, epileptični napadi
16 Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.
16 Na podlagi izsledkov kliničnega preskušanja večkratnega odmerjanja zdravila, v kateri so bolniki dobili do 45 mg desloratadina (9- kratni klinični odmerek), niso opažali nobenih klinično pomembnih učinkov zdravila.
In two single-dose trials, Neoclarityn oral lyophilisate was well tolerated as documented by clinical laboratory findings, physical examinations, vital signs, and ECG interval data.
V dveh preskusih uporabe enkratnih odmerkov so bolniki dobro prenašali zdravilo Neoclarityn peroralni liofilizat, kar je razvidno iz kliničnih laboratorijskih izvidov, pregleda telesa, vitalnih znakov in podatkov o EKG intervalih.
At the recommended dose, Neoclarityn oral lyophilisate was found to be bioequivalent to the conventional tablet formulation of desloratadine.
Ugotovili so, da je zdravilo Neoclarityn peroralni liofilizat v priporočenem odmerku bioekvivalenten običajni formulaciji desloratadina v obliki tablet.
Therefore, the efficacy of Neoclarityn oral lyophilisate is expected to be the same as with the Neoclarityn tablet formulation.
Zato je pričakovana učinkovitost zdravila Neoclarityn peroralni liofilizat enaka učinkovitosti tablet Neoclarityn.
Neoclarityn tablets given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
V kliničnih preskušanjih tablete Neoclarityn pri enkratnem dnevnem odmerku 7, 5 mg niso vplivale na psihofizične sposobnosti bolnikov.
In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced impairment in performance or increase in sleepiness.
V kliničnih farmakoloških preskušanjih sočasna uporaba zdravila Neoclarityn z alkoholom ni okrepila šlodljivega vpliva alkohola na psihomotorične sposobnosti ali povečala zaspanosti pri bolnikih.
Neoclarityn tablets effectively controlled symptoms for 24 hours.
17 Tablete Neoclarityn učinkovito obvladujejo te simptome za čas 24 ur.
Intermittent allergic rhinitis is defined as the presence of symptoms for less
Poleg že uveljavljene klasifikacije, po kateri alergijski rinitis delimo na sezonski in celoletni alergijski rinitis, ga lahko na drug način, to je na podlagi trajanja simptomov, razvrščamo tudi na intermitentni alergijski rinitis in perzistentni alergijski rinitis.
Neoclarityn was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Neoclarityn je učinkovito ublažil težave, povezane s sezonskim alergijskim rinitisom, kar so pokazali skupni rezultati vprašalnika o kakovosti življenja bolnikov z rinitisom in konjunktivitisom.
In single-dose crossover studies of Neoclarityn oral lyophilisate with Neoclarityn tablets, the formulations were bioequivalent.
V navzkrižnih študijah primerjave enkratnega odmerka zdravil Neoclarityn peroralni liofilizat in Neoclarityn tablet sta se ti dve formulaciji izkazali za bioekvivalentni.
The presence of food has no relevant influence on AUC and Cmax of Neoclarityn oral lyophilisate while the presence of food prolongs Tmax for desloratadine from 2.5 to 4 hours and Tmax for 3-OH- desloratadine from 4 to 6 hours.
18 Prisotnost hrane nima pomembnejšega vpliva na vrednost AUC in Cmax za zdravilo Neoclarityn peroralni liofilizat, podaljša pa Tmax desloratadina z 2, 5 na 4 ure in Tmax 3- OH- desloratadina s 4 na 6 ur.
Neoclarityn oral lyophilisate is supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Neoclarityn peroralni liofilizat je na voljo v laminatnih pretisnih omotih za enojni odmerek, ki ga sestavljata film pretisnega omota in folija. ki ga prekriva.
Neoclarityn 2.5 mg orodispersible tablets
Neoclarityn 2, 5 mg orodisperzibilne tablete
Each dose of Neoclarityn orodispersible tablet contains 2.5 mg desloratadine.
Vsaka orodisperzibilna tableta vsebuje 2, 5 mg desloratadina.
Children 6 to 11 years of age: one 2.5 mg Neoclarityn orodispersible tablet placed in mouth once a day for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
Otroci (stari 6 do 11 let): eno 2, 5 mg orodisperzibilno tableto Neoclarityn enkrat na dan za lajšanje simptomov, povezanih z alergijskim rinitisom (vključno z intermitentnim in perzistentnim alergijskim rinitisom) in za zdravljenje urtikarije (glejte poglavje 5. 1).
Adults and adolescents (12 years of age and over): two 2.5 mg Neoclarityn orodispersible tablets placed in the mouth once a day for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
Odrasli in mladostniki (stari 12 let ali več): dve 2, 5 mg orodisperzibilni tableti Neoclarityn enkrat na dan za lajšanje simptomov, povezanih z alergijskim rinitisom (vključno z intermitentnim in perzistentnim alergijskim rinitisom) in za zdravljenje urtikarije (glejte poglavje 5. 1).
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents12 through 17 years of age (see sections 4.8 and 5.1).
Izkušenj iz kliničnih preskušanj glede učinkovitosti uporabe desloratadina pri mladostnikih, starih od 12 do 17 let, je malo (glejte poglavji 4. 8 in 5. 1).
Efficacy and safety of Neoclarityn 2.5 mg orodispersible tablets in children under 6 years of age have not been established.
Pri otrocih, mlajših od 6 let, še niso ugotovili učinkovitosti in varnosti Neoclarityn 2, 5 mg orodisperzibilnih tablet.
This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Neoclarityn orodispersible tablet.
Neoclarityn orodisperzibilne tablete vsebujejo 1, 4 mg fenilalanina na 2, 5 mg odmerek zdravila.
22 Psychiatric disorders Nervous system disorders
22 Halucinacije Psihiatrične motnje
Cardiac disorders Gastrointestinal disorders
Bolezni živčevja
Tachycardia, palpitations Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
Omotica, zaspanost, nespečnost, psihomotorična hiperaktivnost, epileptični napadi
In addition, Neoclarityn orodispersible tablets were well tolerated in a multiple dose trial.
Poleg tega so bolniki dobro prenašali zdravilo Neoclarityn orodisperzibilne tablete tudi v preskušanju z uporabo večkratnih odmerkov zdravila.
At the recommended dose, Neoclarityn 5 mg orodispersible tablet was found to be bioequivalent to the Neoclarityn 5 mg conventional tablet and the Neoclarityn 5 mg oral lyophilisate formulations of desloratadine.
Ugotovili so, da je zdravilo Neoclarityn orodisperzibilna tableta v priporočenem odmerku 5 mg bioekvivalenten običajni formulaciji desloratadina v obliki zdravila Neoclarityn 5 mg tablete in Neoclarityn 5 mg peroralni liofilizat.
In a multiple dose clinical trial, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed.
23 V klinični preskušanjih večkratnega odmerjanja zdravila, v kateri so preiskovanci prejemali do 20 mg desloratadina na dan v času 14 dni, niso opažali nobenih statistično značilnih ali klinično pomembnih učinkov tega zdravila na srce ali ožilje.
23 Desloratadine does not readily penetrate the central nervous system.
Desloratadin ne prehaja zlahka v osrednji živčni sistem.
Neoclarityn tablets effectively controlled symptoms for 24 hours.
Tablete Neoclarityn učinkovito obvladujejo te simptome za čas 24 ur.
5.2 Pharmacokinetic properties
24 5. 2 Farmakokinetične lastnosti
The prevalence of this poor metaboliser phenotype was comparable for adult (6%) and paediatric subjects 2- to 11-year old (6%), and greater among Blacks (18% adult, 16% paediatric) than Caucasians (2% adult, 3% paediatric) in both populations however the safety profile of these subjects was not different from that of the general population.
Prevalenca tega fenotipa slabih metabolizatorjev je bila pri odraslih preiskovancih (6%) podobna kot pri pediatričnih preiskovancih v starosti od 2 do 11 let (6%), medtem ko je bila pri črncih (18% pri odraslih in 16% pri pediatričnih preiskovancih) večja kot pri belcih (2% pri odraslih in 3% pri pediatričnih preiskovancih) iz obeh skupin, profil varnosti zdravila pri teh preiskovancih pa se ni razlikoval od profila varnosti pri splošni populaciji.
In single-dose crossover studies of Neoclarityn 5 mg orodispersible tablets with Neoclarityn 5 mg conventional tablets or Neoclarityn 5 mg oral lyophilisate, the formulations were bioequivalent.
V navzkrižnih študijah primerjave enkratnega odmerka zdravil Neoclarityn 5 mg orodisperzibilne tablete z zdravili Neoclarityn 5 mg tablete in Neoclarityn 5 mg peroralni liofilizat sta se ti dve formulaciji izkazali za bioekvivalentni.
Neoclarityn 2.5 mg tablets has not been evaluated in paediatric patients however in conjunction with the dose finding studies in paediatrics, the pharmacokinetics data for Neoclarityn orodispersible tablets supports the use of the 2.5 mg dose in paediatric patients 6 to 11 years of age.
Uporabe zdravila Neoclarityn 2, 5 mg tablete niso ovrednotili pri pediatričnih bolnikih, vendar pa skupaj s študijami za ugotavljanje pediatričnega odmerka tudi farmakokinetični podatki za zdravilo Neoclarityn orodisperzibilne tablete govorijo v prid uporabi 2, 5 mg odmerka pri pediatričnih bolnikih starih 6 do 11 let.
The presence of food has no relevant influence on AUC and Cmax of Neoclarityn oral lyophilisate while the presence of food prolongs Tmax for desloratadine from 2.5 to 4 hours and Tmax for 3-OH- desloratadine from 4 to 6 hours.
Prisotnost hrane nima pomembnejšega vpliva na vrednost AUC in Cmax za zdravilo Neoclarityn peroralni liofilizat, podaljša pa Tmax desloratadina z 2, 5 na 4 ure in Tmax 3- OH- desloratadina s 4 na 6 ur.
Water had no affect on the bioavailability of Neoclarityn orodispersible tablets.
Voda ni vplivala na biološko uporabnost zdravila Neoclarityn orodisperzibilne tablete.
6.2 Incompatibilities 25 Not applicable.
6. 2 Inkompatibilnosti
Each dose of Neoclarityn orodispersible tablet contains 5 mg desloratadine.
Vsaka orodisperzibilna tableta vsebuje 5 mg desloratadina.
Adults and adolescents (12 years of age and over): one 5 mg Neoclarityn orodispersible tablet placed in the mouth once a day for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
Odrasli in mladostniki (stari 12 let ali več): eno 5 mg orodisperzibilno tableto Neoclarityn enkrat na dan za lajšanje simptomov, povezanih z alergijskim rinitisom (vključno z intermitentnim in perzistentnim alergijskim rinitisom) in za zdravljenje urtikarije (glejte poglavje 5. 1).
27 4.4 Special warnings and precautions for use
28 4. 4 Posebna opozorila in previdnostni ukrepi
Efficacy and safety of Neoclarityn orodispersible tablets in children under 12 years of age have not been established.
Pri otrocih, mlajših od 12 let, še niso ugotovili učinkovitosti in varnosti Neoclarityn orodisperzibilnih tablet.
This product contains 2.9 mg of phenylalanine per 5 mg dose of Neoclarityn orodispersible tablet.
Neoclarityn orodisperzibilne tablete vsebujejo 2, 9 mg fenilalanina na 5 mg odmerek zdravila.
Psychiatric disorders Nervous system disorders
Drugi zelo redki neželeni učinki, o katerih so poročali v okviru postmarketinških izkušenj, so navedeni v spodnji preglednici.
Hallucinations Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
29 Halucinacije Psihiatrične motnje
28 4.9 Overdose
4. 9 Preveliko odmerjanje
In addition, Neoclarityn orodispersible tablets were well tolerated in a multiple-dose trial.
Poleg tega so bolniki dobro prenašali zdravilo Neoclarityn orodisperzibilne tablete tudi v preskušanju z uporabo večkratnih odmerkov zdravila.
Therefore, the efficacy of Neoclarityn orodispersible tablet is expected to be the same as with the Neoclarityn tablet formulation.
Zato je pričakovana učinkovitost zdravila Neoclarityn peroralni liofilizat enaka učinkovitosti tablet Neoclarityn.