FrancophonIA/ELRC3.0 huggingface dataset:
English: In adults and adolescents over 12 years of age, the recommended dose of Aerinaze is one tablet twice a day, taken whole with a full glass of water.
Danish: Hos voksne og unge over 12 år er den anbefalede dosis af Aerinaze én tablet to gange dagligt.
English: The main measures of effectiveness were the change in the severity of hayfever symptoms reported by the patients between before treatment started, and over the entire 15 days of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på ændringen i sværhedsgraden af høfebersymptomerne, som patienterne indberettede, fra før behandlingens start og i løbet af hele den 15 dage lange behandlingsperiode.
English: What is Aerinaze?
Danish: Hvad er Aerinaze?
English: When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Danish: Når receptorerne er blokeret, kan histaminet ikke udøve sin virkning, og det fører til et fald i allergisymptomerne.
English: In both studies, Aerinaze was compared with desloratadine alone and with pseudoephedrine alone.
Danish: I begge undersøgelser blev Aerinaze sammenlignet med desloratadin alene og med pseudoephedrin alene.
English: The patients recorded their symptoms in a diary every 12 hours during the study, scoring on a standard symptom scale how severe the symptoms were over the previous 12-hour period.
Danish: Symptomerne blev af patienterne registreret i et skema, og for hver 12 timer gav de symptomerne score-værdi efter, hvor svære de havde været i den foregående 12 timers periode.
English: Desloratadine is released from its layer immediately after it is taken, while pseudoephedrine is released slowly over 12 hours.
Danish: Desloratadin frigives straks, når man har taget tabletten, mens pseudoephedrin frigives langsomt over 12 timer.
English: Aerinaze is a medicine containing the active substances desloratadine (2.5 mg) and pseudoephedrine (120 mg).
Danish: Aerinaze er et lægemiddel, der indeholder de to aktive stoffer desloratadin (2,5 mg) og pseudoephedrin (120 mg).
English: Desloratadine has been available in the European Union (EU) since 2001, and pseudoephedrine is widely used in medicines that have been available over-the-counter for many years.
Danish: Desloratadin har været på markedet i EU siden 2001, og pseudoephedrin har i mange år haft stor udbredelse i håndkøbsmedicin.
English: It should not be used in people who are taking a monoamine oxidase inhibitor (such as some medicines used to treat depression) or who have stopped taking one of these medicines within the last two weeks.
Danish: Det bør heller ikke anvendes hos patienter, der er i behandling med monoaminoxidasehæmmere (MAO-hæmmere) (f.eks. visse lægemidler mod depression) eller er holdt op med at tage sådanne lægemidler inden for de seneste to uger.
English: For the full list of all side effects reported with Aerinaze, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Aerinaze fremgår af indlægssedlen.
English: In Aerinaze, the two active substances are used together, since an antihistamine alone may not provide adequate relief for patients with nasal congestion.
Danish: I Aerinaze anvendes de to aktive stoffer sammen, da et antihistamin i sig selv ikke altid hjælper tilstrækkeligt på stoppet næse.
English: When looking at all hayfever symptoms except for nasal congestion, patients taking Aerinaze reported a reduction in symptoms of 46.0%, compared with 35.9% in those taking pseudoephedrine alone.
Danish: For alle høfebersymptomer under ét bortset fra stoppet næse mindskede Aerinaze symptomerne med 46,0 %, sammenholdt med 35,9 % med pseudoephedrin alene.
English: The most common side effects with Aerinaze (seen in between 1 and 10 patients in 100) are tachycardia (fast heart rate), dry mouth, dizziness, psychomotor hyperactivity (restlessness), pharyngitis (sore throat), anorexia (loss of appetite), constipation, headache, fatigue (tiredness), insomnia (difficulty sleeping), somnolence (sleepiness), sleep disorders and nervousness.
Danish: De almindeligste bivirkninger af Aerinaze (der ses hos mellem 1 og 10 patienter ud af hver 100) er hjertebanken, mundtørhed, svimmelhed, rastløshed, ondt i halsen, appetitløshed, forstoppelse, hovedpine, træthed, søvnbesvær, søvnighed, søvnforstyrrelser og nervøsitet.
English: When looking at nasal congestion, patients taking Aerinaze had a reduction in symptoms of 37.4%, compared with 26.7% in those taking desloratadine alone.
Danish: Aerinaze mindskede symptomerne ved stoppet næse med 37,4 %, sammenholdt med 26,7 % med desloratadin alene.
English: Aerinaze tablets have two layers, one containing desloratadine, and the other containing pseudoephedrine.
Danish: Aerinaze tabletter består af to lag, hvoraf det ene indeholder desloratadin, og det andet indeholder pseudoephedrin.
English: This reduces the amount of fluid released from the vessels, resulting in less swelling and less mucus production in the nose.
Danish: Derved afgiver karrene mindre væske, så hævelsen og slimproduktionen i næsen mindskes.
English: What benefit has Aerinaze shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Aerinaze?
English: Pseudoephedrine works by stimulating nerve endings to release the chemical noradrenaline, which causes the blood vessels to constrict (narrow).
Danish: Pseudoephedrin virker ved at stimulere nerveenderne til at afgive det kemiske stof noradrenalin, hvilket får blodkarrene til at trække sig sammen.
English: Aerinaze must not be used in people who are hypersensitive (allergic) to desloratadine, pseudoephedrine or any of the other ingredients, to adrenergic agents or to loratadine (another medicine used to treat allergies).
Danish: Aerinaze må ikke anvendes hos patienter, der muligvis er overfølsomme (allergiske) over for desloratadin, pseudoephedrin, andre af indholdsstofferne, adrenerge stoffer eller loratadin (et andet lægemiddel til behandling af allergi).
English: What is Aerinaze used for?
Danish: Hvad anvendes Aerinaze til?
English: Desloratadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Danish: Desloratadin virker ved at blokere de receptorer, der normalt besættes af histamin, som er et allergifremkaldende stof i kroppen.
English: Aerinaze contains two active substances: desloratadine, an antihistamine, and pseudoephedrine, which is a nasal decongestant.
Danish: Aerinaze indeholder to aktive stoffer: desloratadin, der er et antihistamin, og pseudoephedrin, der modvirker stoppet næse.
English: How has Aerinaze been studied?
Danish: Hvordan blev Aerinaze undersøgt?
English: Aerinaze should also not be taken by people who have narrow angle glaucoma (increased pressure inside the eye), urinary retention (difficulty in passing urine), heart or blood vessel diseases including hypertension (high blood pressure), hyperthyroidism (an overactive thyroid gland), or a history or risk of haemorrhagic stroke (stroke caused by bleeding within the brain).
Danish: Aerinaze bør desuden ikke anvendes hos patienter med snævervinklet glaukom (grøn stær, forhøjet tryk i øjet), vandladningsbesvær, hjerte-karsygdomme, herunder for højt blodtryk, for stor produktion af skjoldbruskkirtelhormon, tidligere hjerneblødning eller forhøjet risiko for hjerneblødning.
English: How is Aerinaze used?
Danish: Hvordan anvendes Aerinaze?
English: Treatment for more than 10 days is not advisable, as the medicine's effects on nasal congestion may wear off. Once the nose has cleared, patients can use desloratadine alone.
Danish: Det frarådes at tage medicinen i mere end 10 dage, da dens virkning på stoppet næse efterhånden kan aftage.
English: Aerinaze is used to treat the symptoms of seasonal allergic rhinitis (hayfever, inflammation of the nasal passages caused by an allergy to pollen) in patients who have nasal congestion (a blocked nose).
Danish: Aerinaze anvendes til behandling af symptomer på sæsonbundet allergisk rhinitis (høfeber, dvs. inflammation af næseslimhinden forårsaget af pollenallergi) ledsaget af stoppet næse.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze's benefits are greater than its risks for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion and recommended that Aerinaze be given marketing authorisation.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Aerinaze opvejer risiciene til behandling af symptomerne ved sæsonbundet høfeber ledsaget af stoppet næse.
English: How does Aerinaze work?
Danish: Hvordan virker Aerinaze?
English: *This is based on protein content only.
Danish: *Dette er kun baseret på proteinindholdet.
English: The safety device will be activated immediately.
Danish: Sikkerhedsanordningen vil straks aktiveres.
English: These symptoms generally develop in a rapid fashion.
Danish: Disse symptomer opstår generelt hurtigt.
English: There is no evidence that such an interaction would be harmful.
Danish: Der er ikke bevis for, at en sådan interaktion er skadelig.
English: ● At the request of the European Medicines Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: ● Risk Management Plan (RMP)
Danish: • Risikostyringsplan (RMP)
English: Date of first authorisation: 25 July 2013.
Danish: Dato for første markedsføringstilladelse: 25. juli 2013.
English: This could damage the safety device.
Danish: Det kan beskadige sikkerhedsanordningen.
English: Find a comfortable, well-lit place.
Danish: Find et behageligt, veloplyst sted.
English: Proper treatment of your disease, however, requires close and constant co-operation with your doctor.
Danish: En korrekt behandling af din sygdom kræver imidlertid nøje og konstant samarbejde med lægen.
English: Date of latest renewal: 08 May 2018
Danish: Dato for seneste fornyelse: 8. maj 2018.
English: Take the medicine out of the refrigerator.
Danish: Tag medicinen ud af køleskabet.
English: Your doctor will carry out regular blood tests in order to monitor various blood components and their levels.
Danish: Din læge vil udføre regelmæssige blodprøver for at overvåge forskellige bestanddele i blodet og niveauerne af disse.
English: Do not give this medicine to children and adolescents under 18 years of age because there is only limited experience in children to show that this medicine is safe and works in this age group.
Danish: Giv ikke dette lægemiddel til børn og unge under 18 år, da der kun er begrænset erfaring hos børn til at vise, at dette lægemiddel er sikkert og virker i denne aldersgruppe.
English: If a patient fails to respond to treatment, the patient should undergo further evaluation.
Danish: Hvis en patient ikke responderer på behandlingen, skal patienten gennemgå yderligere evaluering.
English: Tell your doctor if you experience these symptoms.
Danish: Fortæl det til lægen, hvis du oplever disse symptomer.
English: If you have a fever or any of these symptoms, it is important to contact your doctor immediately.
Danish: Hvis du har feber eller et af disse symptomer, er det vigtigt straks at kontakte lægen.
English: Only clear, colourless solutions without particles should be used.
Danish: Kun klare, farveløse opløsninger uden partikler må anvendes.
English: Your doctor or nurse will give you instructions on how to do this.
Danish: Din læge eller sygeplejersken vil vejlede dig i, hvordan du skal gøre det.
English: The relevance of these findings for humans is not known.
Danish: Betydningen af disse fund for mennesker er ukendt.
English: Consequent decrease in efficacy in these patients cannot be excluded on current data.
Danish: En efterfølgende nedsat virkning hos disse patienter kan ikke ekskluderes fra aktuelle data.
English: Do not warm Lonquex in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Du må ikke opvarme Lonquex på nogen anden vis (for eksempel må du ikke varme den i en mikrobølgeovn eller i varmt vand).
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Danish: Det er vigtigt, at du ikke forsøger at give dig selv en injektion, medmindre du har fået særlig træning fra lægen eller sygeplejersken.
English: ITT = Intent-to-treat population (all randomised patients) SD = standard deviation d = days
Danish: ITT = Intent-to-treat-population (alle randomiserede patienter) SD = Standardafvigelse d = Dage
English: The adverse reactions listed below in table 1 are classified according to system organ class.
Danish: Bivirkningerne opstillet nedenfor i tabel 1 er klassificeret i henhold til systemorganklasse.
English: Therefore, no adjustment of the dose is necessary for elderly patients.
Danish: Derfor er ingen dosisjustering nødvendig for ældre patienter.
English: The solution should be visually inspected before use.
Danish: Opløsningen bør inspiceres visuelt før brug.
English: CI = confidence interval
Danish: CI = Konfidensinterval
English: Lonquex may be removed from the refrigerator and stored below 25°C for a maximum single period of up to 3 days.
Danish: Lonquex kan fjernes fra køleskabet og opbevares ved temperaturer under 25 °C i en maksimal enkelt periode på op til 3 dage.
English: The average molecular mass is approximately 39 kDa of which the protein moiety constitutes approximately 48 %.
Danish: Den gennemsnitlige molekylmasse er ca. 39 kDa, hvoraf proteinandelen udgør ca. 48 %.
English: Only use each syringe for one injection.
Danish: Brug kun hver sprøjte til én injektion.
English: Your doctor may suggest that you learn how to inject yourself with this medicine.
Danish: Din læge kan foreslå, at du selv lærer at injicere dig med dette lægemiddel.
English: *See section “Description of selected adverse reactions” below Description of selected adverse reactions
Danish: *Se punktet “Beskrivelse af udvalgte bivirkninger” nedenunder Beskrivelse af udvalgte bivirkninger
English: The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Danish: Muligheden for interaktion med lithium, som også fremmer frigivelsen af neutrofiler, er ikke blevet specifikt undersøgt.
English: The solution should be allowed to reach a comfortable temperature (15°C - 25°C) for injection.
Danish: Opløsningen bør få lov til at nå en komfortabel temperatur (15 °C - 25 °C) til injektionen.
English: Frequency groupings are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighedsgrupperingerne er defineret i henhold til den følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The most suitable places to inject yourself are:
Danish: De mest velegnede steder til injektionen er:
English: If you have missed an injection, contact your doctor to discuss when you should inject the next dose.
Danish: Hvis du har sprunget en injektion over, skal du kontakte lægen for at diskutere, hvornår du bør injicere den næste dosis.
English: There are very limited data (less than 300 pregnancy outcomes) on the use of lipegfilgrastim in pregnant women.
Danish: Der er meget begrænsede data (mindre end 300 gravide forsøgspersoner) fra anvendelse af lipegfilgrastim til gravide kvinder.
English: Once removed from the refrigerator, the medicinal product must be used within this period or disposed of.
Danish: Når det fjernes fra køleskabet, skal lægemidlet anvendes i løbet af denne periode eller bortskaffes.
English: If white blood cells fall to a low level, there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Danish: Hvis antallet af hvide blodlegemer falder til et lavt niveau, kan der ikke være nok tilbage i kroppen til at bekæmpe bakterier, og du kan have en forhøjet infektionsrisiko.
English: If a serious allergic reaction occurs, appropriate therapy with close patient follow-up over several days should be administered.
Danish: Hvis der opstår en alvorlig allergisk reaktion, bør der administreres hensigtsmæssig behandling med nøje opfølgning af patienten i flere dage.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, as the doctor may decide that you should not use this medicine.
Danish: Det er vigtigt at fortælle det til lægen, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, da lægen kan beslutte, at du ikke må bruge dette lægemiddel.
English: Allergic reactions and immunogenicity
Danish: Allergiske reaktioner og immunogenicitet
English: The mean terminal half-lives in the fourth cycle were approximately 39 and 42 hours.
Danish: De gennemsnitlige terminale halveringstider i den fjerde cyklus var ca. 39 og 42 timer.
English: Median ANC (x 109 cells/l)
Danish: Median ANC (x 109 celler/l)
English: These findings are consistent with results from G-CSF and derivatives.
Danish: Disse fund er i overensstemmelse med resultaterne fra G-CSF og derivater.
English: The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Danish: Styrken af dette lægemiddel bør ikke sammenlignes med styrken af et andet pegyleret eller ikke-pegyleret protein fra den samme terapeutiske klasse.
English: • Some changes may occur in your blood, but these will be detected by routine blood tests.
Danish: • Der kan forekomme ændringer af blodet, men det vil opdages under rutinemæssige blodprøver.
English: The incidence of FN varied according to age (from 14.3 % to 71.4 %), with the highest frequency in the oldest age group.
Danish: Forekomsten af febril neutropeni varierede i henhold til alder (fra 14,3 % til 71,4 %) med den største hyppighed i den ældste aldersgruppe.
English: The results of the study are presented in table 3.
Danish: Resultaterne fra studiet vises i tabel 3.
English: This section contains information on how to give yourself an injection of Lonquex under the skin.
Danish: Dette afsnit indeholder oplysninger om, hvordan du kan give dig selv en injektion af Lonquex under huden.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Incidence (%)
Danish: Forekomst (%)
English: Nevertheless, pharmacodynamic effects were similar and independent from gender and injection site.
Danish: Ikke desto mindre var de farmakodynamiske virkninger sammenlignelige og uafhængige mht. køn og injektionssted.
English: If you see blood in the syringe, remove the needle and re-insert it in another place.
Danish: Hvis du kan se blod i sprøjten, fjernes den og den indsættes et andet sted.
English: There could be a risk of reacting to Lonquex too.
Danish: Der kunne også være en risiko for en reaktion over for Lonquex.
English: This may result in lowered pharmacodynamic responses in heavy patients (> 95 kg).
Danish: Dette kan føre til et sænket farmakodynamisk respons hos kraftige patienter (> 95 kg).
English: No pharmacokinetic data are available in patients ≥ 75 years.
Danish: Der foreligger ingen farmakokinetiske data for patienter ≥ 75 år.
English: If there are particles in it or if it is cloudy, you must not use it.
Danish: Hvis den indeholder partikler eller er uklar, må du ikke bruge den.
English: In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal handelsnavnet og batchnummeret for det administrerede lægemiddel tydeligt registreres i patientjournalen.
English: p-value SN
Danish: p-værdi SN
English: Leukocytosis*, Splenomegaly*
Danish: Leukocytose*, splenomegali*
English: Do not use this medicine if you notice that it is cloudy or there are particles in it.
Danish: Brug ikke lægemidlet, hvis du bemærker, at det er uklart eller indeholder partikler.
English: • the top of your thighs,
Danish: • øverst på lårene,
English: Lonquex has not been tested in pregnant women.
Danish: Lonquex er ikke blevet afprøvet hos gravide kvinder.
English: How are the injections given?
Danish: Hvordan gives injektionerne?
English: If you think you are having this type of reaction, you must stop your Lonquex injection and get medical help immediately.
Danish: Hvis du mener, at du har denne type reaktion, skal du stoppe injektionen med Lonquex og straks søge lægehjælp.
English: Most biological medicinal products elicit some level of anti-drug antibody response.
Danish: De fleste biologiske lægemidler udløser et vist niveau af antistofrespons mod lægemidlet.
English: There is evidence that filgrastim and pegfilgrastim may be transported at low levels over the placenta in rats, although no information is available for lipegfilgrastim.
Danish: Der er evidens for, at filgrastim og pegfilgrastim ved lave niveauer kan transporteres over placenta hos rotter, selvom der ikke foreligger nogen information for lipegfilgrastim.
English: These can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly-growing cells).
Danish: Disse tilstande kan skyldes anvendelse af cytotoksisk kemoterapi (medicin, der nedbryder hurtigvoksende celler).
English: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Danish: Patienter med nyere tilfælde af lungeinfiltrater eller pneumoni kan have en højere risiko.
English: It is unknown whether the active substance in this medicine passes into the breast milk.
Danish: Det er ukendt, om det aktive stof i dette lægemiddel udskilles i mælken hos mennesker.
English: • if you have a cough, fever and difficulty breathing.
Danish: • hvis du hoster, har feber og vejrtrækningsbesvær.
English: The safety and efficacy of Lonquex in children and adolescents aged up to 17 years have not yet been established.
Danish: Lonquex' sikkerhed og virkning hos børn og unge i alderen op til 17 år er endnu ikke klarlagt.
English: No adverse events directly attributable to leukocytosis have been reported.
Danish: Der er ikke rapporteret nogen uønskede hændelser, der direkte kan tilskrives leukocytose.
English: Study days, injection of lipegfilgrastim at day 0
Danish: Studiedage, injektion af lipegfilgrastim ved dag 0
English: Do not use it if the date has passed the last day of the month shown.
Danish: Må ikke anvendes, hvis den sidste dato i den nævnte måned er overskredet.
English: Table 1: Adverse reactions System organ class
Danish: Tabel 1: Bivirkninger Systemorganklasse
English: The entire needle and syringe will be drawn back automatically and covered so that you cannot prick yourself (see picture 11).
Danish: Hele kanylen og sprøjten vil automatisk trækkes tilbage og dækkes, så du ikke kan stikke dig selv (se figur 11).
English: What you should do before your injection
Danish: Det skal du gøre før injektionen
English: Tell your doctor if you experience severe musculoskeletal pain.
Danish: Fortæl det til lægen, hvis du oplever svære knogle- og muskelsmerter.
English: In clinical studies with a limited number of elderly patients, there was no relevant age-related difference with regard to the efficacy or safety profiles of lipegfilgrastim.
Danish: I kliniske studier med et begrænset antal ældre patienter var der ingen relevant aldersrelateret forskel med hensyn til profilerne for virkning og sikkerhed af lipegfilgrastim.