FrancophonIA/ELRC3.0 huggingface dataset:
English: VANCOMYCIN HYDROCHLORIDE 0.5G VIAL
Danish: VANCOMYCINHYDROCHLORID 0,5 G HÆTTEGLAS
English: Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 1000MG VIAL
Danish: Vankomicin Cnp VANCOMYCIN 1000 MG HÆTTEGLAS
English: VANCOMYCIN HYDROCHLORIDE 510MG VIAL
Danish: Vancomycin Mip VANCOMYCINHYDROCHLORID 510 MG HÆTTEGLAS
English: Vancomycin Laboratorio Reig Jofré
Danish: Reig Jofré
English: Mip Pharma Gmbh Vancosan
Danish: Mip Pharma Gmbh
English: HYDROCHLORIDE 125MG CAPSULE
Danish: VANCOMYCINHYDROCHLORID 125 MG KAPSEL
English: Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE
Danish: Vancomycin Hydrochloride Hospira Uk
English: Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 500MG VIAL
Danish: Vankomicin Cnp VANCOMYCIN 500 MG HÆTTEGLAS
English: Vancomycin Xellia VANCOMYCIN 250MG CAPSULE, HARD ORAL USE
Danish: Vancomycin VANCOMYCIN 125 MG KAPSEL, HÅRD
English: Vancomicina Labesfal VANCOMYCIN Hydrochloride1000MG vial
Danish: Vancomycin Mip VANCOMYCINHYDROCHLORID 1020 MG HÆTTEGLAS
English: Vancomycin Xellia Pharmaceuticals Aps
Danish: Finland Xellia Pharmaceuticals Aps Vancomycin Xellia
English: POWDER FOR SOLUTION FOR INjection
Danish: PULVER TIL OPLØSNING TIL INJEKTION
English: Vancomycin Nrim VANCOMYCIN 1000MG VIAL
Danish: Vankomicin Lek VANCOMYCIN 1000 MG HÆTTEGLAS
English: Laboratórios Normon, S.A.
Danish: Laboratórios Normon, S.A. Vancomicina Normon
English: Bulgaria
Danish: Irland
English: Vancomycin Xellia VANCOMYCIN 1000MG VIAL
Danish: Xellia Pharmaceuticals Aps Vancomycin VANCOMYCIN 1000 MG PULVER TIL
English: Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 500MG VIAL
Danish: Tyskland Riemser Pharma Gmbh Vancomycin "lederle" 500
English: Vancomycin Noridem VANCOMYCIN 500MG VIAL
Danish: Levovanox VANCOMYCIN 500 MG HÆTTEGLAS
English: Hikma Farmacêutica Vancomycin Hikma VANCOMYCIN
Danish: Vancomycin Hikma
English: Vancomycin Nrim VANCOMYCIN 500MG VIAL
Danish: Vancocin VANCOMYCIN 500 MG HÆTTEGLAS
English: Vancomicina Combino
Danish: Vancomicina Sala
English: Vancomycin Xellia VANCOMYCIN 250MG CAPSULE
Danish: Levovanox VANCOMYCIN 250 MG KAPSEL
English: Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 1000MG VIAL
Danish: Tyskland Riemser Pharma Gmbh Vancomycin "lederle" 1000
English: VANCOMYCIN 1G VIAL POWDER FOR CONCENTRATE FOR SOLUTION FOR
Danish: VANCOMYCIN 50 MG/ML PULVER TIL KONCENTRAT TIL
English: United Kingdom Xellia Pharmaceuticals Aps
Danish: Tyskland Xellia Pharmaceuticals Aps VancoRatiopharm
English: Vanco-Ratiopharm VANCOMYCIN HYDROCHLORIDE
Danish: Vancomycin Ratiopharm
English: Vancomycine Mylan VANCOMYCIN 50MG/ML
Danish: Flynn Pharma Limited Vancocin VANCOMYCIN 50 MG/ML PULVER TIL KONCENTRAT TIL
English: The dose in children depends on their age.
Danish: Dosis for børn afhænger af alderen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Neoclarityn on 15 January 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Neoclarityn den 15. januar 2001
English: Adults and adolescents can use any form of the medicine.
Danish: Til voksne og unge kan der anvendes en hvilken som helst form af lægemidlet.
English: The full EPAR for Neoclarityn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Neoclarityn findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Neoclarityn.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Neoclarityn.
English: Other information about Neoclarityn
Danish: Andre oplysninger om Neoclarityn
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Neoclarityn.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Neoclarityn.
English: The side effects seen in children are similar.
Danish: Der kunne iagttages tilsvarende bivirkninger hos børn.
English: Neoclarityn has also been studied in 416 patients with urticaria.
Danish: Neoclarityn blev også undersøgt hos 416 patienter med urticaria.
English: Neoclarityn is a medicine containing the active substance desloratadine.
Danish: Neoclarityn er et lægemiddel, der indeholder det aktive stof desloratadin.
English: The active substance in Neoclarityn, desloratadine, is an antihistamine.
Danish: Det aktive stof i Neoclarityn, desloratadin, er et antihistamin.
English: In all studies, the effectiveness of Neoclarityn was compared with that of placebo (a dummy treatment).
Danish: I alle undersøgelserne blev Neoclarityn effekt sammenlignet med virkningen af placebo (uvirksom behandling).
English: For more information about treatment with Neoclarityn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Neoclarityn, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.
Danish: Der blev fremlagt resultater af supplerende undersøgelser for at påvise, at sirup, oral oplysning og smeltetabletter optages i kroppen på samme måde som tabletter, og for at vise, at de kan anvendes sikkert hos børn.
English: It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Danish: Det virker ved at blokere de receptorer, på hvilke histamin, et stof i kroppen, som forårsager allergiske symptomer, normalt fastgør sig.
English: In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Neoclarityn was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
Danish: I de to undersøgelser af urticaria var faldet i symptomscoren efter seks ugers behandling med Neoclarityn 58 % og 67 % sammenlignet med 40 % og 33 % for patienter behandlet med placebo.
English: In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%).
Danish: Hos voksne og unge er de hyppigste bivirkninger træthed (1,2 %), tørhed i munden (0,8 %) og hovedpine (0,6 %).
English: Neoclarityn has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
Danish: Neoclarityn blev undersøgt i otte undersøgelser i alt, som omfattede 4 800 voksne og unge med allergisk rhinitis (herunder fire undersøgelser af sæsonbestemt allergisk rhinitis og to undersøgelser af patienter, som også havde astma).
English: Neoclarityn must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Danish: Neoclarityn må ikke anvendes til personer, som er overfølsomme (allergiske) over for desloratadin, loratadin eller et af de øvrige indholdsstoffer.
English: The CHMP decided that Neoclarityn's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Neoclarityn opvejer risiciene ved lindring af symptomer forbundet med allergisk rhinitis eller urticaria og anbefalede udstedelse af markedsføringstilladelse.
English: What is the risk associated with Neoclarityn?
Danish: Hvilken risiko er der forbundet med Neoclarityn?
English: In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%).
Danish: Hos børn under toårsalderen er de hyppigste bivirkninger diarré (3,7 %), feber (2,3 %) og søvnløshed (2,3 %).
English: It is available as a 5 mg tablet, 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ml syrup and a 0.5 mg/ml oral solution.
Danish: Det leveres som 5 mg tablet, som 2,5 mg og 5 mg smeltetabletter (tabletter, der opløses i munden), som 0,5 mg/ml sirup og som 0,5 mg/ml oral opløsning.
English: The effectiveness was measured by looking at the change in the symptoms (itching, number and size of hives, interference with sleep and daytime function) before and after six weeks of treatment.
Danish: Effekten blev målt ved at se på ændringen i symptomerne (kløe, antallet og størrelsen af nældefeberen, interferens med søvn og funktion i dagtimerne) før og efter seks ugers behandling.
English: For the full list of all side effects reported with Neoclarityn, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Neoclarityn fremgår af indlægssedlen.
English: In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Neoclarityn led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
Danish: Til allergisk rhinitis førte en to ugers behandling med Neoclarityn 5 mg, hvis man ser på resultaterne af alle undersøgelserne taget under et, til et fald i symptomscoren på gennemsnitlig 25 til 32 % sammenlignet med et fald på 12 til 26 % hos patienter, som fik placebo.
English: Why has Neoclarityn been approved?
Danish: Hvorfor blev Neoclarityn godkendt?
English: The effectiveness of Neoclarityn was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.
Danish: Effekten af Neoclarityn blev målt ved at se på ændringen i symptomerne (næseflåd, kløe, nysen, tilstopning) før og efter to eller fire ugers behandling.
English: Neoclarityn is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Danish: Neoclarityn anvendes til lindring af symptomer på allergisk rhinitis (betændelse i næsepassagerne, som forårsages af allergi, f.eks. høfeber eller allergi over for støvmider) eller urticaria (en hudlidelse forårsaget af allergi med symptomer, der omfatter kløe og nældefeber).
English: For children from one to five years of age, the dose is 1.25 mg once a day, taken as 2.5 ml syrup or oral solution.
Danish: For børn mellem et og fem år er dosis 1,25 mg en gang dagligt taget som 2,5 ml sirup eller som oral opløsning.
English: What is Neoclarityn?
Danish: Hvad er Neoclarityn?
English: For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet.
Danish: For børn mellem seks og 11 år er dosis 2,5 mg en gang dagligt taget enten som 5 ml sirup eller oral opløsning eller som en 2,5 mg smeltetablet.
English: What benefit has Neoclarityn shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Neoclarityn?
English: How has Neoclarityn been studied?
Danish: Hvordan blev Neoclarityn undersøgt?
English: What is Neoclarityn used for?
Danish: Hvad anvendes Neoclarityn til?
English: How is Neoclarityn used?
Danish: Hvordan anvendes Neoclarityn?
English: How does Neoclarityn work?
Danish: Hvordan virker Neoclarityn?
English: These cases were considered serious in all reports.
Danish: Disse tilfælde blev betragtet som alvorlige i alle rapporter.
English: Some of these events have been reported more than 1-year after initiation of treatment.
Danish: Nogle af disse hændelser er rapporteret mere end 1 år efter påbegyndelse af behandlingen.
English: Prilaz baruna Filipovica 25 10000 Zagreb Croatia
Danish: Prilaz baruna Filipovica 25 10000 Zagreb Kroatien
English: Its terminal half-life is 0.6-2 hours.
Danish: Halveringstiden er 0,6-2 timer.
English: - If you see or hear things which are not there (hallucinations).
Danish: - Hvis De ser eller hører ting, der ikke er der (hallucinationer).
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt (hyppighed kan ikke vurderes ud fra forhåndenværende data)
English: Contact you doctor right away if you notice any of the following symptoms.
Danish: Kontakt omgående Deres læge, hvis De bemærker nogen af følgende symptomer.
English: Hallucinations*, Abnormal dreams
Danish: Hallucinationer* Abnorme drømme
English: Only single cases of reported cases had not recovered at the time they were reported.
Danish: Kun enkelte af de rapporterede tilfælde var ikke i bedring på rapporteringstidspunktet.
English: Blisters: 3 years Bottles: 3 years
Danish: Flasker: 3 år.
English: Tell your doctor or pharmacist if you are smoking or intend to stop smoking.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis De ryger eller har til hensigt at holde op med at ryge.
English: Tablet 30 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: Tablet 30 tabletter ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: It can be used together with or without Levodopa (another medicine that is used to treat Parkinson's disease).
Danish: Det kan bruges sammen med eller uden levodopa (et andet lægemiddel, som anvendes til behandling af Parkinsons sygdom).
English: Your doctor may need to adjust or stop your dose (see section 4).
Danish: Lægen kan være nødt til at ændre Deres dosis eller stoppe behandlingen (se punkt 4).
English: - If you have severe liver problems.
Danish: - hvis De lider af alvorlige leverlidelser.
English: Smoking could decrease the amount of Rasagiline ratiopharm in the blood.
Danish: Rygning kan nedsætte mængden af Rasagilin ratiopharm i blodet.
English: Adverse reactions were mild or moderate and not related to rasagiline treatment.
Danish: Bivirkningerne var milde eller moderate og ikke relaterede til rasagilin behandlingen.
English: - Involuntary movements (dyskinesia) - Headache
Danish: - Ufrivillige bevægelser (dyskinesi) - Hovedpine
English: White, high-density polyethylene bottle with or without a child-resistant cap containing 30 tablets.
Danish: Hvid, ugennemsigtig polyethylen flaske med eller uden børnesikret låg indeholdende 30 tabletter.
English: The robustness of the results for the primary efficacy endpoint, was confirmed in a battery of additional statistical models and was demonstrated in three cohorts (ITT, per protocol and completers).
Danish: Resultaternes styrke for det primære effektmåls vedkommende blev bekræftet af en ekstra række statistiske modeller og blev påvist i tre kohorter (ITT, pr. protokol og gennemførende deltagere).
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
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: Bivirkningerne er angivet nedenfor i tabel 1 og 2 i henhold til systemorganklasse og hyppighed med følgende konventioner: 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: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg indikerer ikke direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt.
English: SNRI/SSRI/tri- and tetracyclic antidepressants
Danish: SNRI/SSRI/tri- og tetracykliske antidepressiva
English: Other cytochrome P450 isoenzymes
Danish: Andre cytochrom P450-isoenzymer
English: This might be enhanced if you take other medicines to treat the symptoms of your Parkinson's disease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking Rasagiline ratiopharm.
Danish: Dette kan forstærkes, hvis De tager anden medicin til behandling af Deres symptomer på Parkinsons sygdom, eller hvis De tager medicin, som kan få Dem til at føle døsighed, eller hvis De drikker alkohol, mens De tager Rasagilin ratiopharm.
English: It is not known whether rasagiline is excreted in human milk.
Danish: Det vides ikke, om rasagilin udskilles i human mælk.
English: Additional cases of malignant melanoma were reported during post-marketing period.
Danish: Der blev rapporteret om flere tilfælde med malignt melanom efter markedsføringen.
English: Tyramine/rasagiline interaction
Danish: Tyramin/rasagilin interaktion
English: These symptoms may resemble those observed with nonselective MAO inhibitors.
Danish: Disse symptomer kan ligne dem, der blev observeret under behandling med non-selektive MAO-hæmmere.
English: Therefore, Rasagiline ratiopharm is not recommended for use under the age of 18.
Danish: Rasagilin ratiopharm anbefales derfor ikke til unge under 18 år.
English: There are no data from the use of rasagiline in pregnant women.
Danish: Der er ingen data fra anvendelse af rasagilin til gravide kvinder.
English: These are called impulse control disorders.
Danish: En sådan adfærd kaldes impulskontrolforstyrrelser.
English: Patients with Parkinson's disease are particularly vulnerable to the adverse reactions of hypotension due to existing gait issues.
Danish: Patienter med Parkinsons sygdom er særligt sårbare over for hypotension pga. deres eksisterende gangforstyrrelser.
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: Fall *See section description of selected adverse reactions Description of selected adverse reactions
Danish: Faldulykker *Se punktet med beskrivelse af udvalgte bivirkninger Beskrivelse af udvalgte bivirkninger
English: Rasagiline selectively inhibits MAO-B and is not associated with increased tyramine sensitivity at the indicated dose (1 mg/day).
Danish: Rasagilin hæmmer selektivt MAO-B og er ikke forbundet med øget følsomhed over for tyramin ved den indicerede dosis (1 mg/dag).
English: You should avoid taking Rasagiline ratiopharm if you are pregnant, as the effects of Rasagiline ratiopharm on pregnancy and the unborn child are not known.
Danish: Du skal undgå at tage Rasagilin ratiopharm, hvis du er gravid, da virkningen af Rasagilin ratiopharm på graviditeten og det ufødte barn er ukendt.
English: Rasagiline pharmacokinetics is linear with dose over the range of 0.5-2 mg in Parkinson's disease patients.
Danish: Rasagilins farmakokinetik er lineær i doser over 0,5-2 mg hos patienter med Parkinsons sygdom.
English: These adverse reactions were not associated with an elevated rate of drug discontinuation.
Danish: Disse bivirkninger blev ikke forbundet med en øget seponering af lægemidler.
English: 4.5 Interaction with other medicinal products and other forms of interaction MAO Inhibitors
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Dextromethorphan
Danish: Dextromethorfan
English: Patients should not drive, operate machinery, or work at heights during treatment if they have previously experienced somnolence and/or have fallen asleep without warning prior to use of rasagiline.
Danish: Patienterne må ikke føre motorkøretøj, betjene maskiner eller arbejde i højder under behandlingen, hvis de tidligere har oplevet somnolens og/eller er faldet i søvn uden forvarsel før brugen af rasagilin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 12. januar 2015 Dato for seneste fornyelse:
English: The metabolism of rasagiline proceeds through two main pathways: N-dealkylation and/or hydroxylation to yield: 1aminoindan, 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: EU/1/14/977/001 EU/1/14/977/002 EU/1/14/977/003 EU/1/14/977/004 EU/1/14/977/005 EU/1/14/977/006 EU/1/14/977/008 EU/1/14/977/009 EU/1/14/977/010
Danish: EU/1/14/977/001 EU/1/14/977/002 EU/1/14/977/003 EU/1/14/977/004 EU/1/14/977/005 EU/1/14/977/006
English: Half of the reported ICD cases were assessed as serious.
Danish: Halvdelen af de rapporterede tilfælde med impulskontrolforstyrrelser blev vurderet som værende alvorlige.
English: There is no relevant use of Rasagiline ratiopharm in the paediatric population in the indication Parkinson's disease.
Danish: Det er ikke relevant at anvende Rasagilin ratiopharm hos den pædiatriske population til indikationen Parkinsons sygdom.
English: Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with rasagiline.
Danish: Patienterne skal informeres om dette og rådes til at udvise forsigtighed, mens de fører motorkøretøj eller betjener maskiner under behandling med rasagilin.
English: If increased somnolence or new episodes of falling asleep during activities of daily living (e.g. watching television, passenger in a car, etc.) are experienced at any time during treatment, the patients should not drive or participate in potentially dangerous activities.
Danish: Hvis der på noget tidspunkt under behandlingen opleves øget somnolens eller nye episoder med indsovning under daglige aktiviteter (f.eks. når de ser fjernsyn, som bilpassager osv.), må patienterne ikke føre motorkøretøj eller deltage i potentielt farlige aktiviteter.
English: Non-clinical data reveal no special hazard for humans based on the standard studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: After oral administration of 14C-labelled rasagiline, elimination occurred primarily via urine (62.6%) and secondarily via faeces (21.8%), with a total recovery of 84.4% of the dose over a period of 38 days.
Danish: Efter peroral indgift af 14C-mærket rasagilin skete udskillelsen primært via urinen (62,6%) og sekundært via fæces (21,8%) med en samlet genfindelse på 84,4% af dosis i løbet af 38 dage.