natgillin/translations-raw huggingface dataset:
The estimated formoterol Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 1030 L, and 647 L, respectively, via population pharmacokinetic analysis. 
S populacijsko farmakokinetično analizo ocenjeni Vc/F (volumen centralnega prostora) formoterola je 1030 l in njegov Vp1/F (volumen perifernega razdelka) je 647 l. V razponu koncentracij od 10 do 500 nmol/l je segala vezava formoterola na beljakovine v plazmi od 46 do 58 %.
In PINNACLE 1 and PINNACLE 2, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by Self-administered Computerised Transitional Dyspnoea Index (SAC TDI) focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2). 
V študiji PINNACLE 1 in PINNACLE 2 je zdravilo Bevespi Aerosphere izboljšalo težko dihanje, kot je bilo dokazano s fokalno oceno računalniško podprte ocene indeksa spreminjanja dispneje v času po navedbi bolnika (SAC TDI-Self-administered Computerised Transitional Dyspnoea Index), v 24 tednih v primerjavi s placebom in glikopironijem (glejte preglednico 2).
INHALER LABEL (ACTUATOR) 
NALEPKA INHALATORJA (SPROŽILNIK)
• For inhalation use only. 
Samo za inhaliranje.
NAMES OF THE MARKETING AUTHORISATION HOLDER 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Aerosphere (N=510) vs placebo (N=223) 
s placebom (N = 223)
In PINNACLE 4, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by TDI focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2). 
V študiji PINNACLE 4 je zdravilo Bevespi Aerosphere izboljšalo težko dihanje, kot je bilo dokazano s fokalno oceno TDI v 24 tednih v primerjavi s placebom in glikopironijem (glejte preglednico 2).
120 actuations (1 inhaler) 
inhalacijska suspenzija pod tlakom 120 sprožitev (1 inhalator)
Bevespi Aerosphere 7.2 micrograms / 5 micrograms pressurised inhalation, suspension glycopyrronium / formoterol fumarate dihydrate 
Bevespi Aerosphere 7,2 mikrograma/5 mikrogramov inhalacijska suspenzija pod tlakom glikopironij/formoterolijev fumarat dihidrat
• Use Bevespi Aerosphere exactly as your doctor tells you to. 
Pri uporabi zdravila Bevespi Aerosphere natančno upoštevajte navodila zdravnika.
6.1 List of excipients 
6.1 Seznam pomožnih snovi norfluran
Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium or formoterol. 
Po uporabi antagonistov muskarinskih receptorjev in simpatikomimetikov, tudi glikopironija in formoterola, se lahko pojavijo učinki na srce in ožilje, npr. motnje srčnega ritma, kakršni sta atrijska fibrilacija in tahikardija.
Bevespi Aerosphere 7.2 mcg/5 mcg pressurised inhalation glycopyrronium/formoterol fumarate dihydrate Inhalation use 
Bevespi Aerosphere 7,2 μg/5 μg inhalacijska tekočina pod tlakom glycopyrronium/formoterol fumarate dihydrate za inhaliranje
Aerosphere (N=551) vs placebo (N=235) 
s placebom (N = 235)
Each single actuation (delivered dose, ex-actuator) contains glycopyrronium bromide 9 micrograms equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate. 
Ena sprožitev (oddani odmerek iz sprožilnika) vsebuje 7,2 mikrograma glikopironija v obliki 9 mikrogramov glikopironijevega bromida in 5 mikrogramov formoterolijevega fumarata dihidrata.
Priming your Bevespi Aerosphere inhaler: 
Osnovna priprava inhalatorja Bevespi Aerosphere:
Each single actuation contains glycopyrronium bromide equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate. 
Ena sprožitev vsebuje 7,2 mikrograma glikopironija v obliki glikopironijevega bromida in 5 mikrogramov formoterolijevega fumarata dihidrata.
• The pointer points to 100 after you take 10 more puffs. 
• Po uporabi dodatnih 10 vpihov kazalec kaže proti oznaki 100.
Aerosphere (N=526) vs placebo (N=219) 
s placebom (N = 219)
Bevespi Aerosphere (N=551) vs formoterol fumarate (N=480) 
s formoterolijevim fumaratom (N = 480)
How to clean your Bevespi Aerosphere inhaler: 
Čiščenje inhalatorja Bevespi Aerosphere:
120 actuations (1 inhaler). 
inhalacijska suspenzija pod tlakom 120 sprožitev (1 inhalator).
• you have an eye problem called narrow-angle glaucoma (also called angle-closure glaucoma) 
• če imate očesno bolezen, imenovano "glavkom ozkega zakotja" (ki jo imenujemo tudi "glavkom zaprtega zakotja").
oC. 
vpihov.
Bevespi Aerosphere (N=510) vs formoterol fumarate (N=437) 
s formoterolijevim fumaratom (N = 437)
Each single puff delivers a dose of 9 micrograms glycopyrronium bromide (equivalent to 7.2 micrograms of glycopyrronium), and 5 micrograms of formoterol fumarate dihydrate. 
Z enim vpihom bolnik prejme odmerek 7,2 mikrograma glikopironija v obliki 9 mikrogramov glikopironijevega bromida in 5 mikrogramov formoterolijevega fumarata dihidrata.
• Prime the inhaler by shaking it and actuating into the air four times before first use or two times when the inhaler has not been used for more than seven days, has been exposed to low temperatures, or has been dropped. 
Če inhalator ni bil uporabljen več kot sedem dni, je bil izpostavljen nizki temperaturi ali je kam padel, za osnovno pripravo zadošča dvakratna sprožitev.
The active substances are glycopyrronium and formoterol fumarate dihydrate. 
Kaj vsebuje zdravilo Bevespi Aerosphere Učinkovini sta glikopironij in formoterolijev fumarat dihidrat.
Pointer 
Kazalec
Bevespi Aerosphere (N=526) vs formoterol fumarate (N=449) 
s formoterolijevim fumaratom (N = 449)
OTHER 
DAN
Talk to your doctor or pharmacist before using Bevespi Aerosphere if: 
Pred uporabo zdravila Bevespi Aerosphere se posvetujte z zdravnikom ali farmacevtom:
Aerosphere (N=510) vs 
Zdravilo Bevespi Aerosphere (N = 510) v prim.
Nervous system disorders 
β-adrenergični blokatorji
Bevespi Aerosphere (N=551) vs glycopyrronium (N=474) 
Zdravilo Bevespi Aerosphere (N = 551) v prim.
Cardiovascular effects 
• mišični krči
LIST OF EXCIPIENTS 
Okence kazalnika odmerkov
Metabolism and nutrition disorders 
Presnovne in prehranske motnje hiperglikemija občasni
Aerosphere (N=526) vs 
Zdravilo Bevespi Aerosphere (N = 526) v prim.
• dry mouth 
Bolezni prebavil suhost ust
Palpitations 
Hipokaliemija
The terminal half-life is approximately 10 hours. 
Končna razpolovna doba je približno 10 ur.
The following indications were agreed upon: 
Dogovorjene so bile naslednje indikacije:
About two third of the dose are excreted unchanged in urine. 
Približno dve tretjini odmerka se izloči nespremenjenega z urinom.
A list of Questions was adopted by the CHMP, highlighting the main areas of divergences. 
CHMP je sprejel seznam vprašanj, v katerih je izpostavil glavna področja odstopanja.
(Slovenia) Brnciceva 1 
(Slovenija) Brnciceva 1
The CHMP agreed with the harmonised text but maintained its lower age limit of 2 years. 
CHMP se je strinjal z usklajenim besedilom, vendar ohranil svojo nižjo starostno omejitev 2 let.
Post-marketing experience 
Postmarketinške izkušnje
The apparent volume of distribution is 0.50 l/kg. 
Navidezni volumen porazdelitve je 0,50 l/kg.
The diluted solution should be taken immediately. 
Razredčeno raztopino je treba zaužiti takoj.
Please follow these instructions, otherwise Zyrtec may not be fully effective. 
Prosimo upoštevajte navodila, drugače zdravilo Zyrtec ne bo popolnoma učinkovito.
McNeil Denmark Aps Bregnerødvej 133 
McNeil Danska Aps Bregnerødvej 133
Your doctor will then decide what measures, if any, should be taken. 
Vaš zdravnik bo nato določil katere ukrepe sprejeti, če je to potrebno.
Your doctor will then assess the severity and decide on any further measures that may be necessary. 
Zdravnik bo ocenil resnost in se odločil za morebitne dodatne ukrepe.
20068 Peschiera Borromeo (MI) Italy 
20068 Peschiera Borromeo (MI) Italija
The new dose will be determined by your Doctor. 
Nov odmerek bo določil vaš zdravnik.
B - 2600 Berchem Belgium 
B - 2600 Berchem Belgija
SLO - 1001 Ljubljiana Slovenia 
SLO - 1001 Ljubljiana Slovenija
Should overdose occur, symptomatic or supportive treatment is recommended. 
Če pride do prevelikega odmerjanja, priporočamo simptomatsko ali podporno zdravljenje.
Kruczkowskiego, 8 00 - 380 Warszawa Poland 
Kruczkowskiego, 8 00 - 380 Warszawa Poljska
Adverse event (WHO-ART) 
Neželeni dogodek (WHO-ART)
Read all of this leaflet carefully because it contains important information for you. 
Pred uporabo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
31-546 Krakow Poland 
31-546 Krakow Poljska
NL-4822 NK Breda Nederland 
NL-4822 NK Breda Nizozemska
For cetirizine very rare clinical data on exposed pregnancies are available. 
Za cetirizin je na voljo zelo malo kliničnih podatkov nosečnic, ki so bile izpostavljene zdravilu.
After an overdose, the side effects described below may occur with increased intensity. 
Po zaužitju prevelikega odmerka se lahko spodaj opisani neželeni učinki pojavijo s povečano intenzivnostjo.
The experimental effects observed in animals or at higher than recommended doses and not in line with the indication should be deleted. 
Izkustvene učinke, ki so bili opaženi pri živalih ali višjih odmerkih od priporočenih in ki niso v skladu z indikacijo, je treba izbrisati.
04010 Borgo San Michele (LT) Italy 
04010 Borgo San Michele (LT) Italija
Sardenya 346 - 350 E - 08025 Barcelona Spain 
Sardenya 346 - 350 E - 08025 Barcelona Španija
Cetirizine 10 mg (n= 3260) 
cetirizin 10 mg (n = 3260)
UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Hungary 
UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Madžarska
[To be completed nationally] {Name and address} {tel} {fax} {e-mail} 
[Dopolniti lokalno] {Ime in naslov} {tel.} {fax} {e-mail}
How and when should you take Zyrtec? 
Kako in kdaj jemati zdravilo Zyrtec?
D-76139 Karlsruhe GERMANY 
D-76139 Karlsruhe NEMČIJA
In particular, frequencies were added to the listing of events, as observed from pharmacovigilance surveys. 
Zlasti so bile na seznam dodane pogostnosti pojavov, kot so bile zaznane s farmakovigilančnimi študijami.
Regarding section 5.1 Pharmacodynamic properties, the MAH was asked to reword section 5.1 and retain only the properties that are relevant with regards to the therapeutic effects. 
V zvezi z razdelkom 5.1 Farmakodinamične lastnosti je bil imetnik dovoljenja za promet z zdravilom zaprošen, da preoblikuje razdelek 5.1 in obdrži le lastnosti, ki so pomembne v zvezi s terapevtskimi učinki.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ZYRTEC AND ASSOCIATED NAMES (SEE ANNEX I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA ZYRTEC IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
08918 Badalona (Barcelona) Spain 
08918 Badalona (Barcelona) Španija
There is no known specific antidote to cetirizine. 
Znanega specifičnega antidota za cetirizin ni.
The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor. 
Trajanje zdravljenja Trajanje zdravljenja je odvisno od vrste, trajanja in poteka vaše bolezni in ga določi vaš zdravnik.
The drops should be poured in a spoon or diluted in water, and taken orally. 
Kapljice je treba nakapati na žlico ali razredčiti v vodi in jih vzeti peroralno.
UCB Pharma Ireland Limited, United Drug House, Magna Drive 
UCB Pharma Irska Limited, United Drug House, Magna Drive
The decrease in cetirizine clearance in these elderly volunteers appeared to be related to their decreased renal function. 
Manjši očistek cetirizina pri teh starejših prostovoljcih je bil videti povezan z zmanjšanim delovanjem ledvic.
Quinta da Fonte 2770-229 Paco de Arcos Portugal 
Quinta da Fonte 2770-229 Paco de Arcos Portugalska
Due to the divergent national decisions taken by Member States concerning the authorisation of Zyrtec, a number of divergences exist in the product information and a referral was therefore triggered by the European Commission Article 30 of Directive 2001/83/EC as amended in order to harmonise the divergent Product Information texts across the EU. 
Ker so države članice sprejele različne odločitve glede dovoljenj za promet z zdravilom Zyrtec, obstajajo razhajanja v informacijah o zdravilu, zato je Evropska komisija v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, sprožila napotitveni postopek za uskladitev različnih besedil v informacijah o zdravilu po vsej EU.
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee, 
- da so bili povzetki glavnih značilnosti zdravila, označevanja in navodil za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, ocenjeni na podlagi predložene dokumentacije in znanstvene razprave v odboru;
The distribution of pharmacokinetic parameters such as peak plasma concentration (Cmax) and area under curve (AUC), is unimodal in human volunteers. 
Porazdelitev farmakokinetičnih parametrov, kot sta največja plazemska koncentracija (Cmax) in površina pod krivuljo (AUC), je unimodalna pri ljudeh prostovoljcih.
The MAH agreed to the text proposed by the CHMP. 
Imetnik dovoljenja za promet z zdravilom se je strinjal z besedilom, ki ga je predložil CHMP.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. 
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/plodu, porod in postnatalni razvoj.
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. 
V 35-dnevni študiji pri otrocih, starih od 5 do 12 let, niso ugotovili tolerance za antihistaminski učinek (zmanjšanje otekline in rdečine) cetirizina.
The extent of bioavailability is similar when cetirizine is given as solutions, capsules or tablets. 
Obseg biološke uporabnosti je podoben, če se cetirizin jemlje v obliki raztopine, kapsul ali tablet.
In 16 member states, treatment with cetirizine is also recommended in infants and toddlers aged 1 to 2 years. 
V 16 državah članicah se zdravljenje s cetirizinom priporoča tudi pri dojenčkih in mlajših otrocih, starih od 1 do 2 let.
In infants and toddlers aged 6 to 24 months, it is reduced to 3.1 hours. 
Pri dojenčkih, starih od 6 do 24 mesecev, je zmanjšana na 3,1 uro.
A harmonized wording for age groups and relevant posology was agreed upon: 
Dogovorjeno je naslednje usklajeno besedilo za starostne skupine in ustrezno odmerjanje:
This medicine is available without prescription. 
Zdravilo je na voljo brez recepta.
The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased. 
Obseg absorpcije cetirizina se zaradi hrane ne zmanjša, čeprav se zmanjša hitrost absorpcije.
Since cetirizine is mainly eliminated via renal route (see section 5.2. 
Glede na to, da se cetirizin v glavnem izloča preko ledvic (glejte poglavje 5.2.)
In vitro receptor binding studies have shown no measurable affinity for other than H1receptors. 
In vitro študije vezave na receptor niso pokazale merljive afinitete za druge receptorje razen za H1.
Content (concentration) 
Pot uporabe zdravila vsebina (koncentracija)
Plasma protein binding of cetirizine is 93 ± 0.3 %. 
Vezava cetirizina na plazemske beljakovine je 93 ± 0,3 %.
Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1receptors. 
Cetirizin, človeški presnovek hidroksizina, je močan in selektiven antagonist perifernih receptorjev H1.
Sanofi Aventis France 9 Boulevard Romain Rolland 75159 Paris Cedex 14 France 
Sanofi Aventis Francija 9 Boulevard Romain Rolland 75159 Paris Cedex 14 Francija
The MAH also reviewed the remaining divergent contra-indications. 
Imetnik dovoljenja za promet z zdravilom je preučil tudi preostale razhajajoče kontraindikacije.
The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula: 
CLcr v ml/min je mogoče oceniti iz koncentracije kreatinina v serumu (mg/dl) po formuli:
UCB Pharma GmbH (AT) Jacquingasse,16-18/3.OG 1030 Wien 
UCB Pharma GmbH (AT) Jacquingasse,16-18/3.OG 1030 Dunaj
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. 
Poleg neželenih učinkov, o katerih so poročali med kliničnimi študijami in so navedeni zgoraj, so v okviru postmarketinških izkušenj poročali tudi o posameznih primerih sledečih neželenih učinkov.
However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol. 
Vendar pa se, kot pri vseh antihistaminikih, odsvetuje sočasno uživanje alkohola.
This is why the harmonized wording does not propose a weight - based posology, as weight is clearly not the only factor to define the dose. 
Zato usklajeno besedilo ne predlaga odmerjanja na podlagi telesne mase, saj ta ne more biti edini dejavnik pri določanju odmerka.
McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6 3UG, UK 
McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6 3UG, Velika Britanija
Cetirizine (n=1656) 
cetirizin (n = 1656)
The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation. 
Pri otrocih, mlajših od 6 let, ni priporočljiva uporaba filmsko obloženih tablet, ker ta oblika ne dopušča ustrezne prilagoditve odmerka.
Thermoformed transparent, colorless, physiologically inert PVC blister strip thermosealed by an aluminium foil covered by suitable lac; in a carton box. 
Toplotno oblikovan, prozoren, brezbarven, fiziološko inerten PVC pretisni omot, toplotno zavarjen z aluminijasto folijo in prevlečen z ustreznim voskom; v kartonasti škatli.
Cetirizine does not modify the protein binding of warfarin. 
Cetirizin ne spremeni vezave varfarina na beljakovine.
Cetirizine exhibits linear kinetics over the range of 5 to 60 mg. 
Cetirizin ima linearno kinetiko v odmerkih od 5 do 60 mg.
LIST OF EXCIPIENTS Also contains lactose. 
SEZNAM POMOŽNIH SNOVI Vsebuje laktozo.
The current paediatric indications are not disharmonised based on the indication itself but with regards to the definition of the paediatric age groups and with regards to the dosing for these groups. 
Trenutne pediatrične indikacije se ne razlikujejo glede same indikacije, ampak glede opredelitve pediatričnih starostnih skupin ter predpisanih odmerkov za posamezno starostno skupino.
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. 
V s placebom nadzorovani študiji cetirizin, ki so ga sedem dni dajali v odmerku 60 mg na dan, ni povzročil statistično pomembnega podaljšanja QT intervala.
The liquid formulations are primarily for children up to 12 years, the solid tablets are for children from 12 years on and for adults. 
Tekoči pripravki so predvsem namenjeni zdravljenju otrok do 12 leta starosti, trde tablete pa za zdravljenje otrok, starejših od 12 let, in odraslih.
The MAH acknowledged that the indication section varies a lot from one Member State to the other but that the wording differences corresponded to three well-identified indications. 
Imetnik dovoljenja za promet z zdravilom priznava, da se besedila z indikacijami med posameznimi državami članicami precej razlikujejo, vendar vse različice ustrezajo trem dobro opredeljenim indikacijam.
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. 
Študije na zdravih prostovoljcih so pokazale, da cetirizin v odmerkih po 5 in 10 mg močno zavira rdečino in oteklino povzročeno z zelo veliko koncentracijo histamina apliciranega v kožo, vendar povezava z učinkovitostjo ni dokazana.
Pregnancy and breast-feeding Ask your doctor for advice before taking any medicine. 
Nosečnost in dojenje Posvetujte se z zdravnikom, preden vzamete katerokoli zdravilo.
Cetirizine does not undergo extensive first pass metabolism. 
Cetirizin ni podvržen obsežnemu prvemu prehodu preko jeter.
If you are a sensitive patient, you may find that the simultaneous use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react. 
Če ste občutljivi, lahko pri vas sočasna uporaba alkohola ali drugih pomirjeval dodatno vpliva na pozornost in sposobnost reagiranja.
United Kingdom: Benadryl allergy oral syrup, Benadryl for children allergy solution, Zirtek allergy relief for children, Zirtek allergy solution, Benadryl allergy solution, Benadryl allergy oral solution 
Velika Britanija: Benadryl allergy oral syrup, Benadryl for children allergy solution, Zirtek allergy relief for children, Zirtek allergy solution, Benadryl allergy solution, Benadryl allergy oral solution
Avenida de Barcelona, 239 08750 Molins de Rei (Barcelona) Spain 
Avenida de Barcelona 239 08750 Molins de Rei (Barcelona) Španija
The MAH also reworded the entire section 4.8 Undesirable effects in accordance with current guidelines and with the QRD comments received. 
Imetnik dovoljenja za promet z zdravilom je preoblikoval tudi celotni razdelek 4.8 Neželeni učinki v skladu s trenutnimi smernicami in prejetimi pripombami po pregledu kakovosti dokumentacije.
Depending on the member state, the posology is based on the weight or the age, or even a combination of both and a number of age groups and posology groups were identified. 
V posameznih državah članicah je tako odmerjanje določeno glede na telesno maso ali starost otroka ali celo kombinacijo obeh dejavnikov, ugotovljene pa so številne starostne skupine ali skupine za odmerjanje.
Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases. 
Čeprav je bila statistično somnolenca pri cetirizinu bolj pogosta kot pri placebu, je bila v večini primerov blaga do zmerna.
Uncommon: agitation 
Občasni: agitacija
Adverse drug reactions (WHO-ART) 
Neželeni učinki (WHO-ART)
UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Germany 
UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Nemčija
UCB Nordic A/S Arne Jacobsens Allé 15 DK-2300 Kobenhavn S Denmark 
UCB Nordic A/S Arne Jacobsens Allé 15 DK-2300 Kobenhavn S Danska
This study supports the safety of administering cetirizine to allergic patients with mild to moderate asthma. 
Ta študija podpira varnost dajanja cetirizina bolnikom z alergijo in blago do zmerno astmo.
To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. 
Za uporabo te preglednice je potrebno predhodno oceniti bolnikov očistek kreatinina (CLcr) v ml/min.
If you feel that the effect of Zyrtec is too weak or too strong, please consult your doctor. 
Če menite, da je učinek zdravila Zyrtec prešibak ali premočan, se posvetujte s svojim zdravnikom.
Taking Zyrtec with food and drink Food does not affect noticeabily the absorbtion of cetirizine. 
Jemanje zdravila Zyrtec skupaj s hrano in pijačo Hrana ne vpliva opazno na absorpcijo cetirizina.
The MAH was asked to revise section 4.5 Interaction with other medicinal products, as no pharmacokinetic interactions are awaited with this substance, since it is not metabolised and two third of the ingested dose are eliminated unchanged in urine. 
Imetnik dovoljenja za promet z zdravilom je bil naprošen tudi za preoblikovanje razdelka 4.5 Medsebojno delovanje z drugimi zdravili, ker se ne pričakuje nobeno farmakokinetično medsebojno delovanje s to snovjo, saj se ta ne presnavlja, dve tretjini zaužitega odmerka pa se izločita nespremenjeni z urinom.
Walton Oaks Dorking Road, Walton on the Hill KT 20 7 NS, Surrey Great Britain 
Walton Oaks Dorking Road, Walton on the Hill KT 20 7 NS, Surrey Velika Britanija