FrancophonIA/ELRC3.0 huggingface dataset:
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: There is no relevant use of AZILECT in the paediatric population in the indication Parkinson's disease.
Danish: Det er ikke relevant at anvende AZILECT hos den pædiatriske population til indikationen Parkinsons sygdom.
English: Not known: frequency cannot be estimated from the available data - Elevated blood pressure - Excessive drowsiness - Sudden onset of sleep
Danish: Ikke kendt (hyppighed kan ikke vurderes ud fra forhåndenværende data) - Forhøjet blodtryk - Overdreven døsighed - Pludselig indsovning
English: Teva Pharma Belgium N.V./S.A./AG, Belgique/Belgien
Danish: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG, Belgique/Belgien
English: Tablet 30 tablets
Danish: Tablet 30 tabletter
English: Symptoms reported following overdose of AZILECT included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).
Danish: Rapporterede symptomer efter en overdosering af AZILECT omfattede let eufori (let form for mani), ekstremt højt blodtryk og serotoninsyndrom (se punkt 4).
English: Very common (may affect more than 1 in 10 people) - Involuntary movements (dyskinesia) - Headache
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) - Ufrivillige bevægelser (dyskinesi) - Hovedpine
English: If you think that you may have taken too many AZILECT tablets, contact your doctor or pharmacist immediately.
Danish: Hvis De mener, at De har taget for mange AZILECT tabletter, skal De straks kontakte Deres læge eller apotekspersonalet.
English: AZILECT contains the active substance rasagiline and it is used for the treatment of Parkinson's disease in adults.
Danish: AZILECT indeholder det aktive stof rasagilin og anvendes til behandling af Parkinsons sygdom hos voksne.
English: - Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome) - If you notice any suspicious skin changes because there is a higher risk of skin cancer (not exclusively melanoma) in patients with Parkinson's disease (see section 2).
Danish: - Enhver kombination af hallucinationer, feber, rastløshed, rysten og svenden (serotoninsyndrom) - Hvis De bemærker nogen mistænkelige hudforandringer, fordi der er højere risiko for hudkræft (ikke udelukkende melanom) hos patienter med Parkinsons sygdom (se punkt 2).
English: The metabolism of rasagiline proceeds through two main pathways: N-dealkylation and/or hydroxylation to yield: 1-aminoindan, 3-hydroxy-N-propargyl-1 aminoindan and 3-hydroxy-1-aminoindan.
Danish: Metaboliseringen af rasagilin sker via to hovedmetaboliseringsveje: N-dealkylation og/eller hydroxylering til 1aminoindan, 3-hydroxy-N-propargyl-1 aminoindan og 3-hydroxy-1-aminoindan.
English: 7 tablets 10 tablets 28 tablets 30 tablets 100 tablets 112 tablets
Danish: 7 tabletter 10 tabletter 28 tabletter 30 tabletter 100 tabletter 112 tabletter
English: What you need to know before you take AZILECT Do not take AZILECT
Danish: Det skal de vide, før de begynder at tage AZILECT Tag ikke AZILECT
English: AZILECT may be taken with or without food.
Danish: AZILECT kan tages i forbindelse med et måltid eller uden for måltiderne.
English: The safety and efficacy of AZILECT in children and adolescents have not been established.
Danish: AZILECTs sikkerhed og virkning hos børn og unge er ikke klarlagt.
English: The recommended dose of rasagiline is 1 mg (one tablet of AZILECT) once daily, to be taken with or without levodopa.
Danish: Den anbefalede dosis rasagilin er 1 mg (en tablet AZILECT) én gang dagligt til indtagelse med eller uden levodopa.
English: Levodopa and other Parkinson's disease medicinal products
Danish: Levodopa og andre lægemidler mod Parkinsons sygdom
English: AZILECT may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson's disease).
Danish: AZILECT kan forårsage døsighed, og at du pludselig falder i søvn under daglige aktiviteter, især hvis du tager andre dopaminerge lægemidler (anvendes til behandling af Parkinsons sygdom).
English: In patients experiencing somnolence/sudden sleep episodes, rasagiline may have major influence on the ability to drive and use machines.
Danish: Hos patienter der oplever somnolens/episoder med pludseligt opstået søvn, kan rasagilin i væsentlig grad påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets or in a bottle containing 30 tablets.
Danish: Tabletterne findes i blisterpakninger med 7, 10, 28, 30, 100 og 112 tabletter eller i en beholder med 30 tabletter.
English: AZILECT is indicated in adults for the treatment of idiopathic Parkinson's disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Danish: AZILECT er indiceret hos voksne ved behandling af idiopatisk Parkinsons sygdom som monoterapi (uden levodopa) eller som kombinationsbehandling (med levodopa) hos patienter med end-of-dose fluktuationer.
English: Teva UK Limited Tel: +44(0) 1977 628500
Danish: United Kingdom Teva UK Limited Tel: +44(0) 1977 628500
English: Depression, Hallucinations*
Danish: Depression Hallucinationer*
English: Conjunctivitis
Danish: Conjunctivities
English: Take the AZILECT carton/ blister or bottle with you to show the doctor or pharmacist.
Danish: Medbring AZILECT æsken/blisterpakningen eller beholderen, når De opsøger Deres læge/skadestue eller apotekspersonalet.
English: AZILECT 1 mg tablets
Danish: AZILECT 1 mg tabletter
English: Teva GmbH Tel: +800 53 23 66 48
Danish: Deutschland Teva GmbH Tel: +800 53 23 66 48
English: If you forget to take AZILECT
Danish: Hvis De har glemt at tage AZILECT
English: *See section description of selected adverse reactions
Danish: *Se punktet med beskrivelse af udvalgte bivirkninger
English: The difference between the mean change from baseline to week 26/termination (LOCF, Last Observation Carried Forward) was statistically significant (UPDRS, parts I-III: for rasagiline 1 mg compared to placebo -4.2, 95% CI [-5.7, -2.7]; p<0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p<0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p<0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
Danish: Forskellen mellem gennemsnitlig ændring fra baseline til uge 26/afslutning (LOCF, Last Observation Carried Forward) var statistisk signifikant (UPDRS, del I-III: forskellen mellem rasagilin 1 mg sammenlignet med placebo var ÷4,2, 95% CI [÷5,7; ÷2,7]; p<0,0001; forskellen mellem rasagilin 2 mg sammenlignet med placebo var ÷3,6, 95% CI [÷5,0; ÷2,1]; p<0,0001, UPDRS Motor, del II: forskellen mellem rasagilin 1 mg sammenlignet med placebo var ÷2,7; 95% CI [÷3,87; ÷1,55], p<0,0001; forskellen mellem rasagilin 2 mg sammenlignet med placebo var ÷1,68; 95% CI [÷2,85; ÷0,51], p=0,0050).
English: Renal impairment No special precautions are required in patients with renal impairment.
Danish: Nedsat nyrefunktion Der er ingen særlige forholdsregler for patienter med nedsat nyrefunktion.
English: Package leaflet: Information for the user AZILECT 1 mg tablets rasagiline
Danish: Indlægsseddel: Information til brugeren AZILECT 1 mg tabletter rasagilin
English: In Parkinson's disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Danish: Hos patienter med Parkinsons sygdom, der fik rasagilin i kombination med vedvarende behandling med levodopa sås ingen klinisk signifikant virkning af levodopa-behandlingen på rasagilin clearance.
English: Do not take the following medicines while taking AZILECT: - Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson's disease,
Danish: Tag ikke følgende lægemidler, mens De er i behandling med AZILECT: - Monoaminooxidasehæmmere (MAO-hæmmere) (f.eks. til behandling af depression eller
English: If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking AZILECT do not drive or operate machinery (see section 2).
Danish: Hvis De har oplevet søvnighed og/eller episoder med pludseligt opstået søvn før, eller mens De tager AZILECT, skal De undlade at køre bil eller betjene maskiner (se punkt 2).
English: If you stop taking AZILECT
Danish: Hvis De holder op med at tage AZILECT
English: Contents of the pack and other information What AZILECT contains
Danish: Pakningsstørrelser og yderligere oplysninger AZILECT indeholder:
English: AZILECT tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.
Danish: AZILECT tabletter fås som hvide til grålighvide, runde, flade tabletter med skrå kant, præget på den ene side med ”GIL” og nedenunder ”1” og uden præg på den anden side.
English: Other medicines and AZILECT
Danish: Brug af anden medicin sammen med AZILECT
English: - If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis De er allergisk over for rasagilin eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Elderly No change in dose is required for elderly patients (see section 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: Adverse reactions are listed below in Tables 1 and 2 by system organ class and frequency using the following conventions: 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: (≥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: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes Excessive daily sleepiness (hypersomnia, lethargy, sedation, sleep attacks, somnolence, sudden onset of sleep) can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Danish: Ekstrem daglig søvnighed (hypersomni, letargi, sedation, søvnanfald, somnolens, pludselig opstået søvn) kan forekomme hos patienter i behandling med dopaminagonister og/eller anden behandling med dopaminerg virkning.
English: Tlf: +47 66775590
Danish: Teva Norway AS Tlf: +47 66775590
English: The recommended dose of AZILECT is 1 tablet of 1 mg taken by mouth once daily.
Danish: Den anbefalede dosis er 1 tablet (1 mg) AZILECT én gang dagligt.
English: In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain, as back and neck pain, and arthralgia in both regimens.
Danish: I kliniske studier af patienter med Parkinsons sygdom var de hyppigst rapporterede bivirkninger: hovedpine, depression, vertigo og influenza (influenza og rhinitis) i monoterapi; dyskinesi, ortostatisk hypotension, fald, mavesmerter, kvalme og opkastning samt tør mund ved supplerende behandling med levodopa; smerter i knogler, led og muskler som ryg- og halssmerter og artralgi i begge regimener.
English: - The active substance is rasagiline.
Danish: - Aktivt stof: Rasagilin.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De bruger anden medicin eller har brugt det for nylig.
English: Serotonin syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes*
Danish: Serotoninsyndrom*, Episoder med ekstrem daglig søvnighed (EDS) og pludselig opstået søvn (SOS)*
English: Talk to your doctor before taking AZILECT - If you have any liver problems - You should speak with your doctor about any suspicious skin changes.
Danish: - hvis De har leverproblemer - hvis De får mistænkelige hudforandringer, skal De tale med Deres læge
English: Each tablet contains 1 mg of rasagiline (as mesilate).
Danish: Hver tablet indeholder 1 mg rasagilin (som mesilat).
English: In study III, the mean difference compared to placebo was -0.94h, 95% CI [-1.36, -0.51], p<0.0001.
Danish: I undersøgelse III var den gennemsnitlige forskel sammenlignet med placebo ÷0,94 timer, 95% CI [÷1,36; ÷0,51], p<0,0001.
English: The mean total daily decrease in the OFF time was similar in the entacapone group (-0.80h, 95% CI [-1.20, -0.41], p<0.0001) to that observed in the rasagiline 1 mg group.
Danish: Den gennemsnitlige totale reduktion i ”off” timer pr. dag var omtrent det samme i entakapongruppen (÷0,80 timer, 95% CI [÷1,20; ÷0,41], p<0,0001) som i rasagilin 1 mg gruppen.
English: AZILECT 1 mg tablets rasagiline
Danish: AZILECT 1 mg tabletter rasagilin
English: In study II, the mean difference in the number of hours spent in the “OFF” state compared to placebo was -0.78h, 95% CI [-1.18, -0.39], p=0.0001.
Danish: I undersøgelse II var den gennemsnitlige forskel i antallet af timer tilbragt i ”off” tilstand sammenlignet med placebo ÷0.78 timer, 95% CI [÷1,18; ÷0,39], p=0,0001.
English: In patients taking AZILECT and/or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed.
Danish: Hos patienter i behandling med AZILECT og/eller andre lægemidler til behandling af Parkinsons sygdom er der set tvangshandlinger, tvangstanker, afhængighedspræget spillelyst, overdrevent pengeforbrug, impulshandling og en unormalt stor sexlyst eller en stigning i seksuelle tanker og følelser.
English: Ask your doctor for advice before you drive and operate machines, since Parkinson's disease itself as well as the treatment with AZILECT may influence your ability to do so. AZILECT can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.
Danish: Spørg Deres læge til råds, inden De kører bil, og inden De arbejder med maskiner, da Parkinsons sygdom tillige med behandlingen med AZILECT kan påvirke evnen til at udføre disse handlinger.
English: Uncommon (may affect up to 1 in 100 people) - Stroke (cerebrovascular accident) - Heart attack (myocardial infarction) - Blistering rash (vesiculobullous rash)
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) - Slagtilfælde (cerebrovaskulært tilfælde) - Hjerteanfald (myokardieinfarkt) - Udslæt med blæredannelse (vesikulobulbært udslæt)
English: - Flatulence - Abnormal results of blood tests (leucopenia) - Joint pain (arthralgia) - Musculoskeletal pain - Joint inflammation (arthritis) - Numbness and muscle weakness of the hand (carpal tunnel syndrome) - Decreased weight - Abnormal dreams - Difficulty in muscular coordination (balance disorder) - Depression - Dizziness (vertigo) - Prolonged muscle contractions (dystonia) - Runny nose (rhinitis) - Irritation of the skin (dermatitis) - Rash - Bloodshot eyes (conjunctivitis) - Urinary urgency
Danish: - Blodtryksfald ved hurtig ændring fra liggende/siddende til stående stilling med symptomer som svimmelhed (ortostatisk hypotension) - Nedsat appetit - Forstoppelse - Mundtørhed - Kvalme og opkastning - Luftafgang fra tarmen - Unormale blodprøveresultater (leukopeni (nedsat antal hvide blodlegemer)) - Ledsmerter (artralgi) - Smerter i muskler og led - Betændelsestilstand i led (artritis) - Følelsesløshed og kraftesløshed i musklerne i hånden (karpaltunnelsyndrom) - Vægttab - Unormale drømme - Manglende koordination af bevægelser (balanceforstyrrelser) - Depression - Svimmelhed - Ufrivillige bevægelser af kroppen (dystoni) - Løbenæse (snue) - Irritation af huden (dermatitis) - Udslæt - Øjenbetændelse med røde øjne (conjunctivitis) - Pludseligt opstået vandladningstrang.
English: ≤ 50 mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100 mg/daily, and paroxetine ≤ 30 mg/daily (see section 4.5).
Danish: men det var tilladt at anvende følgende antidepressiva og doser: amitriptylin ≤ 50 mg dagligt, trazodon ≤ 100 mg dagligt, citalopram ≤ 20 mg dagligt, sertralin ≤ 100 mg dagligt og paroxetin ≤ 30 mg dagligt
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Teva Pharmaceuticals Europe B.V.
English: How to take AZILECT
Danish: Sådan skal De tage AZILECT
English: In vitro studies showed that rasagiline at a concentration of 1 µg/ml (equivalent to a level that is 160 times the average Cmax ~ 5.9-8.5 ng/ml in Parkinson's disease patients after 1 mg rasagiline multiple dosing), did not inhibit cytochrome P450 isoenzymes, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A.
Danish: In vitro undersøgelser viste, at rasagilin ikke hæmmede cytochrom P450 isoenzymer, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 og CYP4A i en koncentration på 1 µg/ml (svarende til en koncentration, som er 160 gange højere end det gennemsnitlige Cmax ∼ 5,98,5 ng/ml hos patienter med Parkinsons sygdom efter indtagelse af 1 mg rasaglin som multipel dosis).
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret AZILECT til Dem personligt.
English: Common (may affect up to 1 in 10 people) - Abdominal pain - Fall - Allergy - Fever - Flu (influenza) - General feeling of being unwell (malaise) - Neck pain - Chest pain (angina pectoris) - Low blood pressure when rising to a standing position with symptoms like dizziness/light headedness (orthostatic hypotension) - Decreased appetite - Constipation - Dry mouth - Nausea and vomiting
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer) - Mavesmerter - Fald - Allergi - Feber - Influenza - En følelse af at være sløj (utilpashed) - Nakkesmerter - Smerter i brystet (angina pectoris)
English: 21 February 2005
Danish: Dato for første markedsføringstilladelse: 21. februar 2005 Dato for seneste fornyelse: 21. september 2009
English: *See section description of selected adverse reactions Adjunct Therapy
Danish: *Se punktet med beskrivelse af udvalgte bivirkninger Kombinationsbehandling
English: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes Rasagiline may cause daytime drowsiness, somnolence, and, occasionally, especially if used with other dopaminergic medicinal products - falling asleep during activities of daily living.
Danish: Rasagilin kan forårsage døsighed i løbet af dagen, somnolens og undertiden indsovning under daglige aktiviteter - især ved anvendelse sammen med andre dopaminerge lægemidler.
English: What AZILECT looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Especially tell your doctor if you are taking any of the following medicines: - Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants) - The antibiotic ciprofloxacin used against infections - The cough suppressant dextromethorphan - Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine
Danish: tricykliske eller tetracykliske antidepressive lægemidler) - Antibiotikummet ciprofloxacin til behandling af infektioner - Det hostestillende middel dextromethorphan - Øjendråber, næsedråber/-spray og slimløsende lægemidler til næse og svælg, der indeholder sympatomimetika, samt forkølelsesmedicin, der indeholder ephedrin eller pseudoephedrin AZILECT bør ikke indtages sammen med antidepressive lægemidler, der indeholder fluoxetin eller fluvoxamin.
English: If you are starting treatment with AZILECT, you should wait at least 5 weeks after stopping fluoxetine treatment.
Danish: De skal vente mindst 5 uger efter at have stoppet behandling med fluoxetin, inden De påbegynder behandling med AZILECT.
English: You must wait at least 14 days after stopping AZILECT treatment and starting treatment with MAO inhibitors or pethidine.
Danish: De skal vente mindst 14 dage efter at have stoppet behandling med AZILECT, inden De påbegynder behandling med fluoxetin eller fluvoxamin.
English: Rasagiline clinical trials did not allow concomitant use of fluoxetine or fluvoxamine with rasagiline, but the following antidepressants and doses were allowed in the rasagiline trials: amitriptyline
Danish: Serotoninsyndrom I de kliniske undersøgelser med rasagilin var samtidig brug af fluoxetin eller fluvoxamin ikke tilladt,
English: Do not stop taking AZILECT without first talking to your doctor.
Danish: Hold ikke op med at tage AZILECT uden først at have talt med Deres læge om det. Spørg lægen eller apotekspersonalet, hvis der er noget, De er i tvivl om.
English: Fall
Danish: Faldulykker
English: Serotonin syndrome
Danish: Nakkesmerter Artritis
English: Cerebrovascular Serotonin
Danish: Тева Фармасютикълс България ЕООД
English: Nervous system Dyskinesia
Danish: Dystoni Karpaltunnelsyndrom Balanceforstyrrelser
English: What AZILECT is and what it is used for What you need to know before you take AZILECT How to take AZILECT
Danish: Det skal De vide, før De begynder at tage AZILECT Sådan skal De tage AZILECT Bivirkninger
English: EU/1/05/322/002 Yttriga vial (glass) 1 vial (flat bottom)
Danish: 1 hætteglas (V-formet bund)
English: (Invented) name Strength Pharmaceutical Form Route of Administration Packaging Package size EU/1/05/322/001 Yttriga vial (glass) 1 vial (V-shaped bottom)
Danish: Lægemiddelform Indgivelsesvej
English: 4 (4 x 1) prefilled syringes (multipack)
Danish: 4 (4 x 1) fyldte injektionssprøjter (multipakning)
English: Always wash your hands prior to performing the following procedures.
Danish: Vask altid hænder, før du udfører følgende fremgangsmåde.
English: Date of first authorisation: 27 August 1997 Date of latest renewal: 20 July 2012
Danish: Dato for første markedsføringstilladelse: 27. august 1997 Dato for seneste fornyelse: 20. juli 2012
English: These reactions are potentially life-threatening.
Danish: Disse reaktioner er potentielt livstruende.
English: The required dose is determined using the following formula:
Danish: De krævede doser bestemmes ved anvendelse af følgende formel:
English: This is a verbatim term.
Danish: Dette er en direkte oversat term.
English: Age Group (years)
Danish: Aldersgruppe (år)
English: White/almost white powder and clear and colourless solvent.
Danish: Hvidt/næsten hvidt pulver og klar og farveløs solvens.
English: BeneFIX can be used for all age groups.
Danish: BeneFIX kan anvendes til alle aldersgrupper.
English: The parameters estimated using the final 2-compartment model are shown in Table 2.
Danish: Parametrene estimeret ved hjælp af den endelige 2-kompartment-model er vist i skema 2.
English: Paediatric population Allergic reactions might be experienced more frequently in children than in adults.
Danish: Pædiatrisk population Allergiske reaktioner kan forekomme hyppigere hos børn end hos voksne.
English: In most of the cases, an infusion rate of up to 4 mL per minute has been used.
Danish: I de fleste tilfælde blev der anvendt en infusionshastighed på op til 4 ml pr. minut.
English: Common to < 1/10
Danish: Almindelig til <1/10
English: Safety analysis of 25 evaluable patients reflected a safety profile as expected.
Danish: En analyse af sikkerheden hos 25 patienter viste en sikkerhedsprofil som forventet.
English: Infants and children had higher clearance, larger volume of distribution, shorter half-life and lower recovery than adolescents and adults.
Danish: Spædbørn og børn havde højere clearance, større fordelingsvolumen, kortere halveringstid og lavere genfinding end unge og voksne.