FrancophonIA/ELRC3.0 huggingface dataset:
English: Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases.
Danish: Selvom forekomsten af døsighed var statistisk mere almindelig end ved placebo, var den mild til moderat i størstedelen af tilfældene.
English: 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.
Danish: Derfor foreslår den harmoniserede formulering ikke en vægtbaseret dosering, da vægt tydeligvis ikke er den eneste faktor, som definerer dosis.
English: 31-546 Krakow Poland
Danish: 31-546 Krakow Polen
English: The systemic exposure with half doses is not documented and insufficient efficacy related to half doses may lead the patients to cumulate other treatments.
Danish: Den systemiske eksponering ved halveret dosis er ikke dokumenteret, og utilstrækkelig effekt ved halve doser kan føre til, at patienter akkumulerer andre behandlinger.
English: Sardenya 346 - 350 E - 08025 Barcelona Spain
Danish: Sardenya 346 - 350 E - 08025 Barcelona Spanien
English: 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.
Danish: Afhængig af medlemsstaten er doseringen baseret på vægten eller alderen eller en kombination af begge dele, og der blev identificeret et antal aldersgrupper og doseringsgrupper.
English: NL-2909 LD Capelle a/d IJsel Nederland
Danish: NL-2909 LD Capelle a/d IJsel Holland
English: 08918 Badalona (Barcelona) Spain
Danish: 08918 Badalona (Barcelona) Spanien
English: D-76139 Karlsruhe GERMANY
Danish: D-76139 Karlsruhe TYSKLAND
English: The experimental effects observed in animals or at higher than recommended doses and not in line with the indication should be deleted.
Danish: De virkninger, som er observeret i undersøgelser med dyr og ved doser, som er højere end de anbefalede og ikke i overensstemmelse med indikationen, skal slettes.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Danish: Dyrestudier viser ikke direkte eller indirekte skadelige virkninger for graviditet, embryoets/fostrets udvikling, fødsel eller den postnatale udvikling.
English: Cetirizine does not modify the protein binding of warfarin.
Danish: Cetirizin modificerer ikke proteinbindingen af warfarin.
English: Cetirizine 10 mg (n= 3260)
Danish: Cetirizin 10 mg (n= 3260)
English: In 16 member states, treatment with cetirizine is also recommended in infants and toddlers aged 1 to 2 years.
Danish: I 16 medlemsstater anbefales behandling med cetirizin også til spædbørn og små børn i alderen 1-2 år.
English: The solution can be swallowed as such.
Danish: Opløsningen kan synkes, som den er.
English: 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.
Danish: De aktuelle pædiatriske indikationer mangler ikke harmonisering baseret på selve indikationen, men med hensyn til definitionen af de pædiatriske aldersgrupper og doseringen til disse grupper.
English: UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Hungary
Danish: UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Ungarn
English: This study supports the safety of administering cetirizine to allergic patients with mild to moderate asthma.
Danish: Dette studie understøtter sikkerheden ved administrering af cetirizin til allergiske patienter med mild til moderat astma.
English: Decongestif & Antihistaminicum
Danish: Decongestif & Antihistaminicu m
English: Belgium McNeil Roderveld 1
Danish: Luxembourg McNeil Roderveld 1
English: 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.
Danish: Indehaveren af markedsføringstilladelsen anerkendte, at indikationsafsnittet varierer meget i de forskellige medlemsstater, men at formuleringsforskellene svarer til tre velidentificerede indikationer.
English: NL-4822 NK Breda Nederland
Danish: NL-4822 NK Breda Holland
English: When a treatment with cetirizine is stopped after repeated administration, the skin recovers its normal reactivity to histamine within 3 days.
Danish: Når behandlingen stoppes efter gentagne administrationer af cetirizin, vil huden genvinde den normale aktivitet mod histamin inden for 3 dage.
English: The decrease in cetirizine clearance in these elderly volunteers appeared to be related to their decreased renal function.
Danish: Faldet i clearance af cetirizin hos frivillige ældre viste sig at være relateret til deres nedsatte nyrefunktion.
English: How and when should you take Zyrtec?
Danish: Hvornår og hvordan skal De tage Zyrtec?
English: The liquid formulations are primarily for children up to 12 years, the solid tablets are for children from 12 years on and for adults.
Danish: De flydende formuleringer er primært beregnet til børn op til 12 år, mens tabletterne er til børn fra 12 år og til voksne.
English: If you feel that the effect of Zyrtec is too weak or too strong, please consult your doctor.
Danish: Hvis De oplever, at virkningen af Zyrtec er for svag eller for stærk, skal De kontakte Deres læge.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ZYRTEC AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF ZYRTEC OG TILKNYTTEDE NAVNE (SE BILAG I)
English: If you develop one of the side effects described above, please inform your doctor.
Danish: Hvis De får en af de bivirkninger, som er beskrevet ovenfor, skal De fortælle det til Deres læge.
English: The extent of bioavailability is similar when cetirizine is given as solutions, capsules or tablets.
Danish: Biotilgængeligheden er ens, når cetirizin administreres som opløsning, kapsler eller tabletter.
English: 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.
Danish: Med hensyn til afsnit 5.1 Farmakodynamiske egenskaber blev indehaveren af markedsføringstilladelsen bedt om at omformulere afsnit 5.1 og kun bevare de egenskaber, som er relevante for den terapeutiske virkning.
English: Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus.
Danish: Tilfældig brug af lægemidlet af en gravid kvinde bør ikke medføre skadelige påvirkninger af fostret.
English: 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.
Danish: Børn, spædbørn og småbørn: Halveringstiden af cetirizin var ca. 6 timer hos børn på 6-12 år og 5 timer hos børn på 2-6 år.
English: If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
Danish: Hvis De er epileptisk patient eller De har risiko for krampeanfald, skal De spørge Deres læge til råds.
English: However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.
Danish: Som det er tilfældet med alle antihistaminer, tilrådes det, at undgå samtidig indtagelse af alkohol.
English: In vitro receptor binding studies have shown no measurable affinity for other than H1receptors.
Danish: In vitro undersøgelser omhandlende receptorbinding har ikke vist nogen målbar affinitet for andre receptorer end H1-receptorer.
English: The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:
Danish: CLcr (ml/min) kan beregnes ud fra bestemmelse af serumkreatinin (mg/dl) ud fra følgende formel:
English: Post-marketing experience
Danish: Erfaring efter markedsføring
English: The distribution of pharmacokinetic parameters such as peak plasma concentration (Cmax) and area under curve (AUC), is unimodal in human volunteers.
Danish: Fordelingen af farmakokinetiske parametre, såsom peak-plasma concentration (Cmax) og areal under kurven (AUC) er unimodal hos frivillige forsøgspersoner.
English: In particular, frequencies were added to the listing of events, as observed from pharmacovigilance surveys.
Danish: Primært blev frekvenser tilføjet til listen over hændelser, som de er observeret i lægemiddelovervågningsundersøgelser.
English: Tablets need to be swallowed with a glass of liquid.
Danish: Tabletterne skal synkes sammen med et glas væske.
English: There is no known specific antidote to cetirizine.
Danish: Der findes ingen specifik antidot til cetirizin.
English: [To be completed nationally] {Name and address} {tel} {fax} {e-mail}
Danish: [Udfyldes nationalt] {Navn og adresse} {tlf} {fax} {email}
English: The MAH also reworded the entire section 4.8 Undesirable effects in accordance with current guidelines and with the QRD comments received.
Danish: Indehaveren af markedsføringstilladelsen omformulerede også hele afsnit 4.8 Bivirkninger i overensstemmelse med de aktuelle retningslinjer og med de modtagne QRD-kommentarer.
English: 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.
Danish: I en 35-dages undersøgelse med børn mellem 5 og 12 år, blev der ikke fundet tolerans mod virkningen af antihistamin (suppression af vabler og blussen).
English: Objective tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily dose in healthy young volunteers.
Danish: Objektive undersøgelser, som blev vist ved andre studier, viste at almindelige dagligdags aktiviteter ikke blev påvirket hos raske unge frivillige forsøgspersoner ved den anbefalede dosis.
English: LIST OF EXCIPIENTS Also contains lactose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også lactose.
English: Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect.
Danish: Symptomer på overdosering er hovedsageligt associeret ved virkninger på CNS eller med virkninger, som kunne tyde på en antikolinerg effekt.
English: Thermoformed transparent, colorless, physiologically inert PVC blister strip thermosealed by an aluminium foil covered by suitable lac; in a carton box.
Danish: Termoformet, transparent, farveløs fysiologisk inaktiv PVC blister strip, som er varmebeskyttet med aluminiumsfolie dækket af egnet lak; i en karton.
English: The frequencies are defined as such: (common: 1 patient out of 100 to 1 out of 10, uncommon: 1 out of 1,000 to 1 out of 100, rare: 1 out of 10,000 to 1 out of 1,000, very rare: less than 1 out of 10,000).
Danish: Frekvenserne er defineret på følgende måde: (almindelig: 1 patient ud af 100 til 1 ud af 10, ikke almindelig: 1 ud af 1000 til 1 ud af 100; sjælden: 1 ud af 10000 til 1 ud af 1000, meget sjælden: mindre end 1 ud af 10000).
English: Creatinine clearance (ml/min)
Danish: Kreatinin clearance (ml/min)
English: CARTON BOX AND BOTTLES
Danish: KARTON OG FLASKER
English: Avenida de Barcelona, 239 08750 Molins de Rei (Barcelona) Spain
Danish: Avenida de Barcelona, 239 08750 Molins de Rei (Barcelona)
English: FI-00700 HELSINKI
Danish: FI-00700 HELSINGFORS
English: If you forget to take Zyrtec Do not take a double dose to make up for forgotten dose.
Danish: Hvis De har glemt at tage Zyrtec De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The Product Information of the tablet and the oral formulations also reflected the additional contraindication related to the excipients.
Danish: Produktinformationen for tabletten og de orale formuleringer afspejler også de yderligere kontraindikationer i forhold til hjælpestofferne.
English: If you are intending to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose.
Danish: Hvis De ønsker at køre, udføre potentielt farlige aktiviteter eller betjene maskiner bør De ikke overskride den anbefalede dosis.
English: Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1receptors.
Danish: Cetirizin, en human metabolit af hydroxycin, er en potent og selektiv perifer H1-receptor antagonist.
English: 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.
Danish: CHMP var enig i, at der ikke er identificeret nogen problemer med sikkerhed eller toksicitet ved brug af cetirizin ved nedsat nyrefunktion i de mange år med kliniske erfaringer, men CHMP vedtog dog en lavere aldersgrænse på 2 år for anvendelsen af cetirizin.
English: According to the guideline of the SPC, negative interactions should be mentioned in the SPC only if they are of clinical interest to the prescriber.
Danish: Ifølge retningslinjerne for produktresuméer skal negative interaktioner kun nævnes i produktresuméet, hvis de er af klinisk interesse for den ordinerende læge.
English: The MAH agreed to the text proposed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen accepterede teksten som foreslået af CHMP.
English: The MAH also reviewed the remaining divergent contra-indications.
Danish: Indehaveren af markedsføringstilladelsen gennemgik også de resterende afvigende kontraindikationer.
English: 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.
Danish: Indehaveren af markedsføringstilladelsen blev bedt om at revidere afsnit 4.5 Interaktion med andre lægemidler og andre former for interaktion, fordi der ikke forventes nogen farmakokinetiske interaktioner med dette stof, da det ikke metaboliseres, og to tredjedele af den indtagne dosis udskilles uændret i urinen.
English: UCB A.E. 580 Avenue Vouliagmenis GR-16452 Argyroupoli Athens
Danish: UCB A.E. 580 Avenue Vouliagmenis GR-16452 Argyroupoli Athen
English: The drug is indicated in adults and children aged 2 years and older in all the member states.
Danish: Lægemidlet er indiceret til voksne og børn på 2 år eller derover i alle medlemsstater.
English: In infants and toddlers aged 6 to 24 months, it is reduced to 3.1 hours.
Danish: Hos spædbørn og småbørn på 6 til 24 måneder er halveringstiden reduceret til 3,1 time.
English: Caution in epileptic patients and patients at risk of convulsions is recommended.
Danish: Forsigtighed tilrådes til epileptiske patienter og til patienter som har risiko for krampeanfald.
English: Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine.
Danish: På grund af cetirizins farmakokinetiske-, farmakodynamiske- og toleranceprofil forventes der ikke interaktioner med dette antihistamin.
English: 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.
Danish: Foruden de bivirkninger, som blev rapporteret under de kliniske studier og som er anført ovenfor, blev følgende isolerede tilfælde af bivirkninger rapporteret efter markedsføring.
English: Cetirizine does not undergo extensive first pass metabolism.
Danish: Cetirizin undergår kun ubetydelig første-passage metabolisering.
English: For cetirizine very rare clinical data on exposed pregnancies are available.
Danish: Der er kun meget få data tilgængelige for eksponering under graviditet.
English: The CHMP acknowledged the problem of translating from old to new formats and the MAH's division of events into frequencies observed in clinical trials and frequencies estimated from post marketing experience could be agreed upon.
Danish: CHMP anerkendte problemet med oversættelse fra gamle til nye formater, og man var enig i indehaveren af markedsføringstilladelsens opdeling af hændelser i hyppighed observeret under kliniske undersøgelser og hyppighed estimeret på basis af erfaring efter markedsføringen.
English: 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.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og reproduktionstoksicitet.
English: 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.
Danish: De doser, som er foreslået til registrering, er påvist som sikre og effektive i mange undersøgelser med børn i alderen 212 år, som vurderet i den kliniske ekspertrapport i indehaveren af markedsføringstilladelsens data.
English: After an overdose, the side effects described below may occur with increased intensity.
Danish: Efter en overdosis kan nedenstående bivirkninger optræde med tiltagende styrke.
English: 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.
Danish: Denne formulering (filmovertrukket tablet) bør ikke anvendes til børn under 6 år, da denne formulering ikke tager hensigtsmæssig tilpasning af dosis i betragtning.
English: McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6 3UG, UK
Danish: Storbritannien McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6 3UG, Storbritannien
English: Cetirizine (n=1656)
Danish: Cetirizin (n=1656)
English: These guidelines apply unless your Doctor has given you different instructions on how to use Zyrtec.
Danish: De følgende anvisninger er gældende, medmindre lægen har givet Dem andre anvisninger vedrørende brugen af Zyrtec.
English: Dosing adjustments for adult patients with impaired renal function Group
Danish: Dosisjusteringer for voksne patienter med nedsat nyrefunktion Gruppe
English: In adults, all three indications are treated by a 10 mg daily dose of cetirizine.
Danish: Hos voksne behandles alle tre indikationer med en daglig dosis på 10 mg cetirizin.
English: At the first signs of a hypersensitivity reaction, stop taking Zyrtec.
Danish: Ved det første tegn på en overfølsomhedsreaktion, skal De stoppe med at tage Zyrtec.
English: Following side effects have been reported in post marketing experience.
Danish: Følgende bivirkninger er indberettet efter markedsføring.
English: 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.
Danish: Patienter, som ønsker at køre, involvere sig i potentielt farlige aktiviteter eller betjene maskiner bør ikke overskride den anbefalede daglige dosis og bør tage hensyn til deres respons på lægemidlet.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ALUMINIUM BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS PVC/ALUMINIUM BLISTER
English: Do not use Zyrtec after the expiry date which is stated on the box and bottle.
Danish: Brug ikke Zyrtec efter den udløbsdato, der står på æsken og flasken.
English: DK-2300 Kobenhavn S
Danish: DK-2300 København S
English: Cetirizine is not effectively removed by dialysis.
Danish: Cetirizin elimineres ikke effektivt ved dialyse.
English: Regarding the dosing by age group, the MAH defended the same dosing for age group 12 to 18 as in adults because the increase in body weight is compensated by a decrease in clearance, allowing for an equivalent systemic exposure.
Danish: Vedrørende dosering efter aldersgruppe forsvarede indehaveren af markedsføringstilladelsen den samme dosering til aldersgruppen 12-18 år som til voksne, fordi den øgede legemsvægt kompenseres af et fald i clearance, hvilket giver en tilsvarende systemisk eksponering.
English: The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.
Danish: Absorption af cetirizin reduceres ikke ved samtidig fødeindtagelse, selvom absorptionshastigheden er reduceret.
English: Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache.
Danish: Kliniske studier har vist, at cetirizin ved den anbefalede dosis har mindre bivirkninger på CNS, herunder døsighed, træthed, svimmelhed og hovedpine.
English: Contra-indicated
Danish: Kontraindiceret
English: Refer to the following table and adjust the dose as indicated.
Danish: Se nedenstående skema og justér dosis som anvist.
English: Invented name
Danish: Særnavn Navn
English: 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.
Danish: Den foreslåede dosering til børn er afprøvet i kliniske undersøgelser, men stammer også fra doseringstilpasninger baseret på legemsvægt og clearance, som varierer efter, hvor modent det renale system er.
English: Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride.
Danish: Dette forsvinder for det meste ved seponering af behandlingen med cetirizindihydrochlorid.
English: United Kingdom: Benadryl one a day, Benadryl one a day relief, Zirtek allergy relief tablets
Danish: England: Benadryl one a day, Benadryl one a day relief, Zirtek allergy relief tablets
English: 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
Danish: England: Benadryl allergy oral syrup, Benadryl for children allergy solution, Zirtek allergy relief for children, Zirtek allergy solution, Benadryl allergy solution, Benadryl allergy oral solution
English: 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.
Danish: Hvis De er en følsom patient, kan De opdage, at samtidig brug af alkohol og andre lægemidler som virker dæmpende på centralnervesystemet, kan påvirke Deres opmærksomhed og reaktionstid.
English: UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Germany
Danish: UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Tyskland
English: Please ask your doctor for advice; if necessary, you will take a lower dose.
Danish: Hvis De har nedsat nyrefunktion, skal De spørge Deres læge til råds; om nødvendigt, skal De tage en lavere dosis.
English: UCB SA Pharma Secteur Chemin du Foriest, B-1420 Braine l´Alleud Belgium
Danish: UCB SA Pharma Secteur Chemin du Foriest, B-1420 Braine l´Alleud Belgien
English: Due to the profile of cetirizine, no interactions with other drugs are expected.
Danish: På grund af cetirizins profil kan der ikke forventes interaktioner med andre lægemidler.
English: Walton Oaks Dorking Road, Walton on the Hill KT 20 7 NS, Surrey Great Britain
Danish: Walton Oaks Dorking Road, Walton on the Hill KT 20 7 NS, Surrey Storbritannien
English: Taking Zyrtec with food and drink Food does not affect noticeabily the absorption of cetirizine.
Danish: Brug af Zyrtec sammen med mad og drikke Mad påvirker ikke optagelsen af cetirizin væsentligt.
English: Cetirizine exhibits linear kinetics over the range of 5 to 60 mg.
Danish: Cetirizin udviser liniær kinetik inden for dosisområdet 5 til 60 mg.
English: - Body as a whole: common: fatigue
Danish: Hele kroppen: Almindelig: træthed