FrancophonIA/ELRC3.0 huggingface dataset:
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 2.5mg Tablet
Danish: Accord Healthcare Limited Methotrexat Accord Methotrexat 2,5mg tablet
English: Methotrexate 0.55ml/27.5mg
Danish: Methotrexat 0,55ml/27,5mg
English: Метожект Pen Methotrexate 15mg/0.3ml
Danish: Метожект Pen Methotrexat 15mg/0,3ml
English: Methotrexate Sodium 2.742mg Tablet
Danish: Methotrexatnatrium 2,742mg tablet
English: Metotreksat Ebewe Methotrexate 10mg Tablet
Danish: Metotreksat Ebewe Methotrexat 10mg tablet
English: Methotrexaat Ab Methotrexate 25mg/Ml
Danish: Methotrexaat Ab Methotrexat 25mg/ml
English: Metotreksat Ebewe Methotrexate 2.5mg Tablet
Danish: Metotreksat Ebewe Methotrexat 2,5mg tablet
English: Methotrexate Pfizer Methotrexate 2.5mg Tablet
Danish: Methotrexate Pfizer Methotrexat 2,5mg tablet
English: Метожект Pen Methotrexate 17.5mg/0.35ml
Danish: Метожект Pen Methotrexat 17,5mg/0,35ml
English: Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Injection
Danish: Intramuskulær anvendelse | Intratekal anvendelse | Intravenøs injektion
English: Methotrexate Sodium 8.226mg/Ml
Danish: Methotrexatnatrium 8,226mg/ml
English: Methotrexate Disodium 8.22mg/0.3ml
Danish: Methotrexatdinatrium 8,22mg/0,3ml
English: Methotrexate Orion Methotrexate 2.5mg Tablet
Danish: Methotrexate Orion Methotrexat 2,5mg tablet
English: Methotrexate Gry Methotrexate Disodium 5483.7mg/50ml
Danish: Methotrexate Gry Methotrexatdinatrium 5483,7mg/50ml
English: Methotrexate Sodium 548.4mg/20ml
Danish: Methotrexatnatrium 548,4mg/20ml
English: Metotrexat Astron Methotrexate 20mg/0.4ml
Danish: Metotrexat Astron Methotrexat 20mg/0,4ml
English: Metotrexato Pfizer Methotrexate 1g Bottle Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use |
Danish: Metotrexato Pfizer Methotrexat 1g flaske Injektionsvæske, opløsning
English: Methotrexaat Teva Methotrexate 17.5mg Syringe
Danish: Methotrexaat Teva Methotrexat 17,5mg injektionssprøjte
English: Methotrexate 20mg Syringe
Danish: Methotrexat 20mg injektionssprøjte
English: Metotrexat Astron Methotrexate 12.5mg/0.25ml
Danish: Metotrexat Astron Methotrexat 12,5mg/0,25ml
English: Methotrexat Medac Methotrexate 25mg/Ml
Danish: Methotrexat Medac Methotrexat 25mg/ml
English: Methotrexate Gry Methotrexate Disodium 548.37mg/20ml
Danish: Methotrexate Gry Methotrexatdinatrium 548,37mg/20ml
English: Methotrexate 25mg Syringe
Danish: Methotrexat 25mg hætteglas
English: Метожект Pen Methotrexate 27.5mg/0.55ml
Danish: Метожект Pen Methotrexat 27,5mg/0,55ml
English: Metotrexat Astron Methotrexate 22.5mg/0.45ml
Danish: Metotrexat Astron Methotrexat 22,5mg/0,45ml
English: Methotrexate Teva Methotrexate 500mg/20ml
Danish: Methotrexate Teva Methotrexat 500mg/20ml
English: Methotrexate 7.5mg Tablet
Danish: Methotrexat 7,5mg tablet
English: Methotrexate Disodium 5.48mg
Danish: Methotrexatdinatrium 5,48mg
English: Метожект Pen Methotrexate 7.5mg/0.15ml
Danish: Метожект Pen Methotrexat 7,5mg/0,15ml
English: Methotrexate 0.5ml/25mg
Danish: Methotrexat 0,5ml/25mg
English: Metotrexat Astron Methotrexate 10mg/0.2ml
Danish: Metotrexat Astron Methotrexat 10mg/0,2ml
English: Metotrexat Astron Methotrexate 15mg/0.3ml
Danish: Metotrexat Astron Methotrexat 15mg/0,3ml
English: Metotrexat Astron Methotrexate 17.5mg/0.35ml
Danish: Metotrexat Astron Methotrexat 17,5mg/0,35ml
English: Methotrexaat Pch Methotrexate 2.5mg Tablet
Danish: Methotrexaat Pch Methotrexat 2,5mg tablet
English: Methotrexate 2.5mg Tablet
Danish: Methotrexat 2,5mg tablet
English: Methotrexat Ebewe Methotrexate 10mg Tablet
Danish: Methotrexat Ebewe Methotrexat 10mg tablet
English: Methotrexate 5mg Tablet
Danish: Methotrexat 5mg tablet Tablet
English: Methotrexat Ebewe Methotrexate 10mg/Ml
Danish: Methotrexat Ebewe Methotrexat 10mg/ml
English: Methotrexat Ebewe Methotrexate 20mg/Ml
Danish: Methotrexat Ebewe Methotrexat 20mg/ml
English: Metotrexat Astron Methotrexate 27.5mg/0.55ml
Danish: Metotrexat Astron Methotrexat 27,5mg/0,55ml
English: Methotrexate 15mg Syringe
Danish: Methotrexat 15mg injektionssprøjte
English: Metotrexato Teva Methotrexate 52mg/2ml
Danish: Metotrexato Teva Methotrexat 52mg/2ml
English: Метожект Pen Methotrexate 25mg/0.5ml
Danish: Метожект Pen Methotrexat 25mg/0,5ml
English: Methotrexate Gry Methotrexate Disodium 5.48mg/2ml
Danish: Methotrexate Gry Methotrexatdinatrium 5,48mg/2ml
English: Methotrexat Ebewe Methotrexate 2.5mg Tablet
Danish: Methotrexat Ebewe Methotrexat 2,5mg tablet
English: Metotreksat Cipla Methotrexate 2.5mg Tablet
Danish: Metotreksat Cipla Methotrexat 2,5mg tablet
English: Methotrexate Teva Methotrexate 2.5mg/Ml
Danish: Methotrexate Teva Methotrexat 2,5mg/ml
English: Methotrexat Gry Methotrexate Disodium 54.84mg/2ml
Danish: Methotrexat Gry Methotrexatdinatrium 54,84mg/2ml
English: Metotrexato Pfizer Methotrexate 25mg/Ml
Danish: Metotrexato Pfizer Methotrexat 25mg/ml
English: Methotrexate Sodium 54.84mg/2ml
Danish: Methotrexatnatrium 54,84mg/2ml
English: Methotrexaat Teva Methotrexate 10mg Syringe
Danish: Methotrexaat Teva Methotrexat 10mg injektionssprøjte
English: United Kingdom Accord Healthcare Limited Methotrexate Accord Healthcare
Danish: Storbritannien Accord Healthcare Limited Methotrexate Accord Healthcare
English: Metotrexato Cipla Methotrexate 2.5mg Tablet
Danish: Metotrexato Cipla Methotrexat 2,5mg tablet
English: Metotrexate Ebewe Methotrexate 10mg/Ml
Danish: Metotrexate Ebewe Methotrexat 10mg/ml
English: Metotrexat Astron Methotrexate 25mg/0.5ml
Danish: Metotrexat Astron Methotrexat 25mg/0,5ml
English: Metotrexat Astron Methotrexate 7.5mg/0.15ml
Danish: Metotrexat Astron Methotrexat 7,5mg/0,15ml
English: Methotrexate Teva Methotrexate 26mg/Ml
Danish: Methotrexate Teva Methotrexat 26mg/ml
English: Methotrexate 12.5mg Syringe
Danish: Methotrexat 12,5mg injektionssprøjte
English: United Kingdom Accord Healthcare Limited Methotrexate Accord
Danish: Storbritannien Accord Healthcare Limited Methotrexate Accord
English: Methotrexaat Teva Methotrexate 12.5mg Syringe
Danish: Methotrexaat Teva Methotrexat 12,5mg injektionssprøjte
English: Methotrexate Pfizer Methotrexate 25mg/Ml
Danish: Methotrexate Pfizer Methotrexat 25mg/ml
English: Solution For Injection/Infusion
Danish: Koncentrat til injektions/infusionsvæske, opløsning
English: Methotrexaat Teva Methotrexate 22.5mg Syringe
Danish: Methotrexaat Teva Methotrexat 22,5mg injektionssprøjte
English: Methotrexate Disodium 8.23mg/Ml
Danish: Methotrexatdinatrium 8,23mg/ml
English: Methotrexate 22.5mg Syringe
Danish: Methotrexat 22,5mg injektionssprøjte
English: Methotrexate Disodium 21.94mg/Ml
Danish: Methotrexatdinatrium 21,94mg/ml
English: Solution For Injection Intravenous Use
Danish: Intramuskulær anvendelse | Intravenøs anvendelse
English: Metotreksat Ebewe Methotrexate 5mg Tablet
Danish: Metotreksat Ebewe Methotrexat 5mg tablet Tablet
English: Methotrexate Teva Methotrexate 50mg/2ml
Danish: Methotrexate Teva Methotrexat 50mg/2ml
English: Methotrexat Ebewe Methotrexate 5mg Tablet
Danish: Methotrexat Ebewe Methotrexat 5mg tablet Tablet
English: Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use | Intraventricular Use
Danish: Intraarteriel brug | Intramuskulær brug | Intratekal brug | Intravenøs brug | Intraventikulær brug
English: Methotrexate Disodium 8.22mg/Ml
Danish: Methotrexatdinatrium 8,22mg/ml
English: Methotrexate Teva Methotrexate Sodium 10mg Tablet
Danish: Methotrexate Teva Methotrexatnatrium 10mg tablet
English: Metotrexato Pfizer Methotrexate 100mg Vial
Danish: Metotrexato Pfizer Methotrexat 100mg hætteglas
English: Concentrate For Solution For Injection
Danish: Koncentrat til injektionsvæske, opløsning
English: Methotrexate Cipla Methotrexate 2.5mg Tablet
Danish: Methotrexate Cipla Methotrexat 2,5mg tablet
English: Methotrexat ”ebew e”
Danish: Methotrexat ”ebewe”
English: Solution For Injection Subcutaneous Use
Danish: Intramuskulær anvendelse | Subkutan anvendelse
English: Metotrexato Teva Methotrexate 26ml/Ml
Danish: Metotrexato Teva Methotrexat 26mg/ml
English: Accord Healthcare Limited Metotrexát Accord Methotrexate 50mg/20ml
Danish: Accord Healthcare Limited Metotrexát Accord Methotrexat 50mg/20ml
English: Metotrexato Pfizer Methotrexate 5mg Vial
Danish: Metotrexato Pfizer Methotrexat 5mg hætteglas
English: Metotressato Teva Methotrexate 25mg/Ml
Danish: Metotressato Teva Methotrexat 25mg/ml
English: Solution For Injection Intramuscular Use | Intravenous Injection | Subcutaneous Use
Danish: Intramuskulær anvendelse | Intravenøs injektion| Subkutan anvendelse
English: Methotrexate Disodium 1096mg Vial
Danish: Methotrexatdinatrium 1096mg hætteglas
English: Intraarterial Use | Intramuscular Use | Intrathecal Use | Intratumoral Use | Intravenous Use
Danish: Intraarterial anvendelse | Intramuskulær anvendelse | Intratekal anvendelse | Intratumoral anvendelse | Intravenøs anvendelse
English: Methotrexaat Teva Methotrexate 25mg/Ml
Danish: Methotrexaat Teva Methotrexat 25mg/ml
English: Methotrexate Teva Methotrexate Sodium 2.5mg Tablet
Danish: Methotrexate Teva Methotrexatnatrium 2,5mg tablet
English: Solution For Injection Intramuscular Use
Danish: Intramuskulær anvendelse
English: Methotrexate Sodium 5.484mg Vial
Danish: Methotrexatnatrium 5,484mg hætteglas
English: Methotrexate Disodium 20mg/Ml
Danish: Methotrexatdinatrium 20mg/ml
English: Methotrexate Sodium 54.84mg Vial
Danish: Methotrexatnatrium 54,84mg hætteglas
English: Methotrexate 10mg Syringe
Danish: Methotrexat 100mg hætteglas
English: Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use
Danish: Intraarterial anvendelse | Intramuskulær anvendelse | Intravenøs anvendelse
English: Methotrexate Teva Methotrexate 25mg/Ml
Danish: Methotrexate Teva Methotrexat 25mg/ml
English: Methotrexate Disodium 5483mg Vial
Danish: Methotrexatdinatrium 5483mg hætteglas
English: Netherlands Accord Healthcare Limited Methotrexaat Accord
Danish: Accord Healthcare Limited Methotrexaat Accord
English: Czech Republic Ebewe Pharma
Danish: Rumænien Ebewe Pharma
English: Metotreksat Ebewe Methotrexate Disodium 10mg/Ml
Danish: Metotreksat Ebewe Methotrexatdinatrium 10mg/ml
English: Methotrexaat Teva Methotrexate 7.5mg Syringe
Danish: Methotrexaat Teva Methotrexat 7,5mg injektionssprøjte
English: Methotrexate Sodium 548.4mg Vial
Danish: Methotrexatnatrium 548,4mg hætteglas
English: Methotrexate Disodium 54.83mg Vial
Danish: Methotrexatdinatrium 54,83mg hætteglas
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/10ml
Danish: Accord Healthcare Limited Methotrexat Accord Methotrexat 1000mg/10ml
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 5000mg/50ml
Danish: Accord Healthcare Limited Methotrexat Accord Methotrexat 5000mg/50ml
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 50mg/2ml
Danish: Accord Healthcare Limited Methotrexat Accord Methotrexat 50mg/2ml
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 500mg/5ml
Danish: Accord Healthcare Limited Methotrexat Accord Methotrexat 500mg/5ml
English: Methotrexate Disodium 548.37mg Vial
Danish: Methotrexatdinatrium 548,37mg hætteglas
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/40ml
Danish: Accord Healthcare Limited Methotrexat Accord Methotrexat 1000mg/40ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 5000mg/50ml
Danish: Accord Healthcare Limited Metotrexato Accord Methotrexat 5000mg/50ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 1000mg/10ml
Danish: Accord Healthcare Limited Metotrexato Accord Methotrexat 1000mg/10ml
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 500mg/20ml
Danish: Accord Healthcare Limited Methotrexat Accord Methotrexat 500mg/20ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 1000mg/10ml
Danish: Accord Healthcare Limited Metotreksat Accord Methotrexat 1000mg/10ml
English: Solution For Injection Intramuscular Use | Intravenous Use | Oral Use | Subcutaneous Use
Danish: Intramuskulær anvendelse | Intratekal anvendelse | Intravenøs anvendelse | Subkutan anvendelse
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 50mg/2ml
Danish: Accord Healthcare Limited Metotrexato Accord Methotrexat 50mg/2ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 50mg/2ml
Danish: Accord Healthcare Limited Metotreksat Accord Methotrexat 50mg/2ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 5000mg/50ml
Danish: Accord Healthcare Limited Metotreksat Accord Methotrexat 5000mg/50ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 500mg/5ml
Danish: Accord Healthcare Limited Metotrexato Accord Methotrexat 500mg/5ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 500mg/5ml
Danish: Accord Healthcare Limited Metotreksat Accord Methotrexat 500mg/5ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 500mg/20ml
Danish: Accord Healthcare Limited Metotrexato Accord Methotrexat 500mg/20ml
English: Concentrate For Solution For Infusion
Danish: Koncentrat til infusionsvæske, opløsning
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 1000mg/40ml
Danish: Accord Healthcare Limited Metotrexato Accord Methotrexat 1000mg/40ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 1000mg/10ml
Danish: Accord Healthcare Limited Metotrexat Accord Methotrexat 1000mg/10ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 50mg/2ml
Danish: Accord Healthcare Limited Metotrexat Accord Methotrexat 50mg/2ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 5000mg/50ml
Danish: Accord Healthcare Limited Metotrexat Accord Methotrexat 5000mg/50ml
English: Accord Healthcare Limited Metotrexát Accord Methotrexate 1000mg/40ml
Danish: Accord Healthcare Limited Metotrexát Accord Methotrexat 1000mg/40ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 1000mg/40ml
Danish: Accord Healthcare Limited Metotreksat Accord Methotrexat 1000mg/40ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 500mg/5ml
Danish: Accord Healthcare Limited Metotrexat Accord Methotrexat 500mg/5ml
English: Accord Healthcare Limited Metotrexát Accord Methotrexate 500mg/20ml
Danish: Accord Healthcare Limited Metotrexát Accord Methotrexat 500mg/20ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 1000mg/40ml
Danish: Accord Healthcare Limited Metotrexat Accord Methotrexat 1000mg/40ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 500mg/20ml
Danish: Accord Healthcare Limited Metotreksat Accord Methotrexat 500mg/20ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 500mg/20ml
Danish: Accord Healthcare Limited Metotrexat Accord Methotrexat 500mg/20ml
English: Methotrexate Disodium 10mg Tablet
Danish: Methotrexatdinatrium 10mg tablet
English: Methotrexate Disodium 2.5mg Tablet
Danish: Methotrexatdinatrium 2,5mg tablet
English: Solution For Injection Intramuscular Use | Intravenous Use
Danish: Intramuskulær anvendelse | Intratekal anvendelse | Intravenøs anvendelse
English: Methotrexate Disodium 27.41mg Vial
Danish: Methotrexatdinatrium 27,41mg hætteglas
English: Solution For Injection Intraarticular Use | Intramuscular Use | Intrathecal Use | Intravenous Use
Danish: Intraartikulær anvendelse | Intramuskulær anvendelse | Intratekal anvendelse | Intravenøs anvendelse
English: Methotrexate Disodium 10.96mg Vial
Danish: Methotrexatdinatrium 10,96mg hætteglas
English: No other interaction studies have been performed.
Danish: Der er ikke udført andre interaktionsundersøgelser.
English: 18 months.
Danish: 18 måneder.
English: An updated RMP should be submitted: • At the request of the European Medicines Agency;
Danish: Der skal indsendes en opdateret RMP: • på anmodning fra Det Europæiske Lægemiddelagentur
English: 6 hours.
Danish: 6 timer.
English: Appropriate aseptic precautions should be taken.
Danish: Der skal træffes passende aseptiske forholdsregler.
English: The following side effects may happen with this medicine:
Danish: Følgende bivirkninger kan forekomme med dette lægemiddel:
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen er den sidste dag i den nævnte måned.
English: That means it is essentially ‘sodium-free'.
Danish: Det er således stort set “natriumfrit”.
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra en mikrobiologisk synsvinkel skal præparatet anvendes straks.
English: The dose may be divided up into smaller amounts.
Danish: Dosis kan opdeles i mindre mængder.
English: This medicine is not for use in children and adolescents under 18 years of age because it has not been studied in this age group.
Danish: Dette lægemiddel er ikke til brug hos børn og unge under 18 år, da det ikke er undersøgt hos denne aldersgruppe.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA Not applicable.
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA Ikke relevant.
English: Other sources of information
Danish: Andre informationskilder
English: Total volume: ________mL
Danish: Totalt volumen: ________ml
English: No data are available.
Danish: Der foreligger ingen data.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: No dose adjustment is recommended based on age.
Danish: Der anbefales ikke dosisjustering på grundlag af alder.
English: • The active substance is tilmanocept.
Danish: • Det aktive stof er tilmanocept.
English: Italia
Danish: Italien
English: Individual benefit/risk justification
Danish: Individuel begrundelse af benefit/risk-forholdet
English: Children and adolescents
Danish: Børn og unge
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: Frequency categories are defined as follows: 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) and not known (frequency cannot be estimated from the available data).
Danish: Hyppighedskategorierne defineres som følger: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Whatman Grade 1, 3MM, 31ET Chromatography strip
Danish: Whatman Grade 1, 3MM, 31ET Chromatography strimmel
English: The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Danish: Den administrerede aktivitet skal i alle tilfælde være så lav som rimeligt muligt for at opnå de nødvendige diagnostiske oplysninger.
English: For injection
Danish: Til injektion
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelig (forekommer hos indtil 1 ud af 100 behandlede):
English: To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Danish: For at muliggøre øjeblikkelig intervention i akutte situationer skal de fornødne lægemidler og det fornødne udstyr såsom endotrakeal tube og ventilator være umiddelbart tilgængelige.
English: • high levels of calcium in the blood
Danish: • for højt calciumindhold i blodet
English: Origin Line 1 cm from Bottom
Danish: Startlinje 1 cm fra underkant
English: Elderly patients aged 65 or older (32%) were evaluated in clinical studies; no safety issues were identified.
Danish: Ældre patienter over 65 år (32 %) er vurderet i de kliniske undersøgelser, uden at der er konstateret sikkerhedsproblemer.
English: See section 4.
Danish: Se afsnit 4.
English: Patient preparation
Danish: Forberedelse af patienten
English: d. Calculate the percent radiochemical purity (% RCP) as follows:
Danish: d. Beregn den radiokemiske renhedsprocent (% RCP) på følgende måde:
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 risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Summary of safety profile
Danish: Resumé af sikkerhedsprofilen
English: • if you have experienced any signs of allergic reaction (listed in section 4) after previous admistration of Lymphoseek
Danish: • hvis du tidligere har oplevet tegn på en allergisk reaktion (anført i afsnit 4) efter at have fået Lymphoseek
English: Their receipt, storage, use, transfer, and disposal are subject to the regulations and/or appropriate licenses of the competent official organisation.
Danish: Modtagelse, opbevaring, anvendelse, overførsel og bortskaffelse skal ske i overensstemmelse med de relevante bestemmelser og/eller påkrævede tilladelser fra den kompetente officielle organisation.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du bruger dette lægemiddel, da den indeholder vigtige oplysninger.
English: The place depends on the type of tumour.
Danish: Placeringen afhænger af svulstens art.
English: It will be the smallest quantity necessary to get the desired information.
Danish: Det vil være den mindste mængde, der er nødvendig for at undersøgelsen kan give de nødvendige oplysninger.
English: Chronic or acute overdose is unlikely to occur given the total injection amount.
Danish: Kronisk eller akut overdosering er usandsynlig på baggrund af den totale injicerede mængde.
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Danish: For hver patient skal eksponeringen for stråling kunne begrundes med den forventede fordel.
English: It is not a treatment for your illness.
Danish: Det er ikke til behandling af sygdommen.
English: There are no data from the use of Lymphoseek in pregnant women.
Danish: Der foreligger ingen data fra anvendelse af Lymphoseek hos gravide kvinder.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved et indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Specific warnings
Danish: Særlige advarsler
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Ikke relevant.
English: • irritation or pain where the injection is given (including the breast and skin)
Danish: • irritation eller smerter på indsprøjtningsstedet (herunder brystet og huden)
English: Lymphoseek must not be used after the expiry date which is stated on the carton and label after “Exp”.
Danish: Lymphoseek må ikke anvendes efter den udløbsdato, der står på kartonen og etiketten efter “Exp”.
English: Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed.
Danish: Der er ikke udført omfattende dosisområde- eller dosisjusteringsundersøgelser med lægemidlet hos normale eller særlige populationer.
English: The following information is intended for the specialist only.
Danish: Følgende oplysninger er udelukkende tiltænkt speciallægen.
English: Lymphoseek will only be used in special controlled areas.
Danish: Lymphoseek vil kun blive anvendt i særlige, kontrollerede lokaler.
English: Follow appropriate radiation safety precautions during preparation and administration.
Danish: Følg passende forholdsregler for strålingssikkerhed under fremstilling og administration.