FrancophonIA/ELRC3.0 huggingface dataset:
English: Respiratory Tract Infections
Danish: Luftvejsinfektioner
English: IFN 44 mcg (n=411)
Danish: Interferonbeta-1a 44 mikrog (n=411)
English: Ocrevus must be diluted before it is given to you.
Danish: Ocrevus skal fortyndes inden du får det. Fortyndingen vil blive foretaget af sundhedspersonalet.
English: What Ocrevus looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Percentage change in brain volume from Week 24 to Week 120
Danish: Procentuel ændring i hjernevolumen fra Uge 24-120 Relativ reduktion i hastighed af tab af hjernevolumen
English: What Ocrevus is and what it is used for What you need to know before you are given Ocrevus How Ocrevus is given
Danish: Det skal du vide, før du begynder at bruge Ocrevus Sådan skal du bruge Ocrevus Bivirkninger
English: Women of child bearing potential
Danish: Opbevares utilgængeligt for børn
English: · The next 600 mg doses of Ocrevus will be given as a single infusion.
Danish: • Efterfølgende doser af Ocrevus gives som en enkelt infusion af 600 mg. Hver infusion vil tage ca. 3 timer og 30 minutter.
English: There were no life-threatening IRRs.
Danish: Der var ingen livstruende infusionsrelaterede reaktioner (se pkt.
English: Sodium
Danish: Natriumindhold
English: The Reference Member State were Estonia, Latvia, Lithuania, Netherlands, Spain, United Kingdom.
Danish: De berørte medlemsstater var Estland, Letland, Litauen, Nederlandene, Spanien og Det Forenede Kongerige.
English: The Sweden referred the reasons for disagreement to the EMEA on 3 March 2006.
Danish: Sverige fremsendte begrundelserne for uenighederne til EMEA den 3. marts
English: Stada Artzneimittel submitted applications for mutual recognition of Doxastad 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Sweden on 4 July 2004.
Danish: Stada Artzneimittel indgav ansøgninger om gensidig anerkendelse af Doxastad 4 mg depottabletter og tilknyttede navne på grundlag af den markedsføringstilladelse, Sverige udstedte den 4. juli 2004.
English: The Marketing Authorisation Holder provided written explanations on 06 April 2006.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 6. april 2006.
English: Doxastad 4 mg prolonged release tablets and associated names (Doxazosin) is 1 is a receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Danish: Doxastad 4 mg depottabletter og tilknyttede navne (doxazosin) er et alfa-1-receptor-blokerende stof, som anvendes til behandling af patienter med essentiel hypertension og til symptomatisk behandling af benign prostatahyperplasi.
English: The scope of the referral was to agree whether Doxastad 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Danish: Formålet med indbringelsen var at opnå enighed om, hvor vidt frigivelsesprofilen for Doxastad 4 mg depottabletter afviger væsentligt fra det oprindelige lægemiddel og eventuelt medfører øget forekomst af bivirkninger såsom svimmelhed og hypotension, hvorvidt der er væsentlige forskelle i resultaterne af testbatcher i enkeltdosisfasen af undersøgelserne 5208 og 1995 og hvor vidt ansøgeren ved udformningen af bioækvivalensundersøgelserne afviger fra CHMP's retningslinjer, navnlig når det gælder virkningen af fødevarer.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxastad 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Doxastad 4 mg depottabletter og tilknyttede navne Internationalt fællesnavn ( INN): Doxazosin
English: During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxastad 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: I lyset af de samlede data, der var blevet fremlagt, og den faglige debat i udvalget var CHMP på sit møde i juni 2006 af den opfattelse, at benefit-risk forholdet er gunstigt for Doxastad 4 mg depottabletter og tilknyttede navne, at de rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: *Relative Potency by a mice potency test compared to a reference vaccine efficacious in sheep and cattle **Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep.
Danish: **Relativ styrke bestemt ved en styrketest i mus, som blev sammenlignet med en referencevaccine, der blev påvist at være effektiv hos får.
English: --1 Each dose of 2 ml of vaccine contains one of the following inactivated bluetongue virus strains: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1
Danish: --1 Hver dosis på 2 ml vaccine indeholder en inaktiveret bluetonguevirusstamme: Inaktiveret bluetonguevirus, serotype 1, stamme BTV-1/ALG2006/01 E1
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1
Danish: Inaktiveret bluetonguevirus, serotype 8, stamme BTV-8/BEL2006/02
English: Inactivated bluetongue virus, serotype 4, strain SPA-1/2004 RP** ≥ 0.8
Danish: Inaktiveret bluetonguevirus, serotype 4, stamme SPA-1/2004
English: 1 dose (1 ml) contains: Hepatitis A virus (inactivated)1,2
Danish: 1 dosis (1 ml): Hepatitis A-virus (inaktiveret)1,2
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Danish: 3 produceret i gærceller (Saccharomyces cerevisiae) ved rekombinant DNA-teknologi 4 adsorberet på aluminiumphosphat
English: More information
Danish: Yderligere oplysninger
English: 27 November 2015 EMA/134145/2015
Danish: Den 27. november 2015 EMA/134145/2015
English: More detailed information on such dose adjustment is provided in the product information.
Danish: Nærmere oplysninger om en sådan dosisjustering findes i produktinformationen.
English: Always follow the instructions of your healthcare professional.
Danish: Følg altid anvisningerne fra din sundhedsperson.
English: Recommendations for patients and carers
Danish: Anbefalinger for patienter og omsorgsgivere
English: 1 In exceptional cases your dose may need to be changed because of differences in the way the high-strength and standard strength solutions are taken up into the body - your doctor will advise you if this is needed.
Danish: 1 I særlige tilfælde kan det være nødvendigt at ændre din dosis pga. forskelle i den måde, højstyrkeopløsninger og opløsninger af sædvanlig styrke optages i kroppen på - lægen vil sige det til dig, hvis dette bliver nødvendigt.
English: Recommendations for healthcare professionals
Danish: Anbefalinger til sundhedspersoner
English: • Always carefully check the product selected in electronic prescribing or dispensing systems.
Danish: • Kontrollér altid omhyggeligt det valgte produkt i systemerne til elektronisk medicinordination og dispensering.
English: Read the instructions in your package leaflet carefully before using this medicine.
Danish: Læs indlægssedlens anvisninger grundigt, før du bruger denne medicin.
English: • Ensure that your patients are adequately informed on how to use their high-strength insulin.
Danish: • Sørg for, at dine patienter er tilstrækkeligt informeret om, hvordan de skal bruge deres højstyrkeinsulin.
English: Focus on colour differentiation, warning statements on carton/label and other safety design features (such as tactile elements on the pre-filled pen).
Danish: Gør opmærksom på forskelle i farver, advarsler på kartonen/etiketten og andre sikkerhedsdetaljer (såsom følbare elementer på den fyldte pen).
English: • During the switch to high-strength insulin and in the weeks after the switch you should measure your blood sugar levels more frequently.
Danish: • Ved skift til højstyrkeinsulin og i ugerne efter bør du få målt blodsukkeret oftere.
English: Further information on the safe use of these medicines and other ways to minimise the possible risk of medication errors with these medicines can be found in the guidance on risk minimisation strategies for high-strength and fixed-combination insulin products.
Danish: Yderligere oplysninger om sikker brug af disse lægemidler og andre måder at minimere risikoen for medicineringsfejl på findes i vejledning om strategier til risikominimering for højstyrkeinsulin og faste kombinationsprodukter med insulin.
English: The strength of the insulin formulation should also be always included in the prescription.
Danish: Insulinets styrke skal også altid være angivet i ordinationen.
English: Guidance on prevention of medication errors with highstrength insulins
Danish: Vejledning om forebyggelse af medicineringsfejl med højstyrkeinsulin
English: Pharmacists should also check that patients have been trained on how to use the new pen.
Danish: Apotekspersonalet bør desuden kontrollere, at patienterne har fået instruktion i at bruge den nye pen.
English: • Pharmacists should be aware that insulins are now available in different strengths.
Danish: • Apotekspersonale bør være klar over, at insulin nu findes i forskellige styrker.
English: • Patients who are blind or with poor vision must be instructed to always get assistance from another person who has good vision and is trained in using the insulin pen device.
Danish: • Blinde eller svagtseende patienter skal instrueres om altid at få hjælp fra en anden person, som ser godt og er instrueret i at bruge insulinpennen.
English: • If different short-and long-acting insulins are being prescribed together, the differences in appearance and use between the two pen devices must be highlighted.
Danish: • Hvis der ordineres forskellige korttidsvirkende og langtidsvirkende insulintyper sammen, skal forskellene i udseende og brug mellem de to penne fremhæves.
English: Examples of high-strength insulin formulations are Tresiba (200 units/ml insulin degludec) and Humalog (insulin lispro 200 units/ml).
Danish: Eksempler på formuleringer af højstyrkeinsulin er Tresiba (200 enheder/ml insulin degludec) og Humalog (insulin lispro 200 enheder/ml).
English: The dose counter of the pen device displays the number of units of insulin irrespective of strength.
Danish: Dosistælleren på pennen viser antal enheder insulin uanset styrken.
English: • Tell patients to closely monitor their blood sugar levels when starting high-strength insulin and in the weeks after.
Danish: • Fortæl patienterne, at de skal have overvåget blodsukkeret ved påbegyndelse af behandlingen med højstyrkeinsulin og i ugerne efter.
English: In addition, healthcare professionals are encouraged to take the following precautions when storing and dispensing high strength insulins:
Danish: Sundhedspersoner opfordres desuden til at træffe følgende forholdsregler ved opbevaring og dispensering af højstyrkeinsulin:
English: Medicines containing high-strength insulin may allow patients to receive a high dose in a single injection, and help meet an increasing need for higher doses of insulin.
Danish: Højstyrkeinsulin giver patienterne mulighed for at få en høj dosis med en enkelt injektion, og imødekommer det stigende behov for højere doser insulin.
English: • If you are using other types of insulin alongside your high-strength insulin, always check the strength on the packaging and the label of each type of insulin before every injection to avoid mixing them up.
Danish: • Hvis du bruger andre typer insulin sammen med højstyrkeinsulin, skal du altid kontrollere styrken på pakningen og etiketten for hver type insulin før hver indsprøjtning for at undgå at forveksle dem.
English: Patients and healthcare professionals are therefore advised to take extra care when using highstrength insulin medicines and to carefully follow the recommendations given below.
Danish: Patienter og sundhedspersoner tilrådes derfor at udvise ekstra forsigtighed ved brug af højstyrkeinsulin, og nøje at følge nedenstående anbefalinger.
English: • Ensure that electronic and paper systems used to prescribe and dispense these medicines facilitate correct selection of the medicine and avoid confusion with other medicines.
Danish: • Sørg for, at de elektroniske systemer og papirsystemer, der anvendes til at ordinere og dispensere sådanne lægemidler, letter korrekt valg af lægemidlet og undgåelse af forveksling med andre lægemidler.
English: A high-strength insulin is a medicine that contains insulin at a concentration of more than the standard 100 units/ml, which for many years has been the only strength available across the EU.
Danish: Højstyrkeinsulin er et lægemiddel med insulin i højere koncentration end de sædvanlige 100 enheder/ml, som i mange år har været den eneste styrke på markedet i EU.
English: • Pharmacists are encouraged to check that patients and carers are able to read the strength of insulin and the dose counter of the pen device before dispensing the medicine.
Danish: • Apotekspersonale opfordres til at kontrollere, at patienter og omsorgsgivere er i stand til at aflæse insulinets styrke og pennens dosistæller, før lægemidlet udleveres.
English: • If the concentration of insulin stated on your medicine pack is higher than 100 units/ml, you are using high-strength insulin.
Danish: • Hvis den koncentration af insulin, der står på din medicinpakning, er højere end 100 enheder/ml, er det et højstyrkeinsulin.
English: Therefore, when switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit to unit basis, but a higher Toujeo dose (approx. 10-18%) may be needed to achieve target ranges for plasma glucose level.
Danish: Skift fra insulin glargin 100 enheder/ml til Toujeo kan derfor gøres på enhed-tilenhed-basis, men det kan være nødvendigt med en højere dosis Toujeo (ca. 10-18 %) for at nå målområdet for plasmaglukose.
English: • Always prescribe the insulin dose in units (“units” to be spelled out and stated in lower case) and include the dose frequency.
Danish: • Ordiner altid insulindosis i enheder ("enheder" skrevet uforkortet med små bogstaver), og angiv også en dosishyppighed.
English: • Explain differences in the design of the package and the pre-filled pen for high-strength insulins and standard-strength insulins, especially if the patient has been transferred from standardstrength insulin to high-strength insulin.
Danish: • Forklar forskellen i udformningen af pakningen og af den fyldte pen for højstyrkeinsulin og insulin af standardstyrke, navnlig hvis patienten er skiftet fra insulin af standardstyrke til højstyrkeinsulin.
English: • Ensure that storage arrangements for combination insulin medicines facilitate correct selection of the medicine and avoid confusion with other medicines.
Danish: • Sørg for, at kombinerede lægemidler med insulin opbevares på en måde, der fremmer korrekt valg af lægemidlet og undgåelse af forveksling med andre lægemidler.
English: • When switching patients from standard-strength insulin to an insulin formulation that is not bioequivalent (such as Toujeo, insulin glargine 300 units/ml), switching can be done on a unit to unit basis, but the dose may need to be adjusted to achieve target ranges for plasma glucose level.
Danish: • Når patienterne skifter fra insulin af standardstyrke til en insulinformulering, der ikke er bioækvivalent (såsom Toujeo, insulin glargin 300 enheder/ml), kan skiftet ske på enhed-tilenhed basis, men det kan være nødvendigt at justere dosis for at nå målområdet for plasmaglukose.
English: • If you have any questions speak to your healthcare professional.
Danish: • Spørg din sundhedsperson, hvis der er mere, du vil vide.
English: Toujeo (insulin glargine 300 units/ml), although it is also a high-strength insulin, is not bioequivalent to insulin glargine 100 units/ml (such as Lantus) which means that these insulins are not interchangeable.
Danish: Toujeo (insulin glargin 300 enheder/ml), som, selv om det også er et højstyrkeinsulin, ikke er bioækvivalent med insulin glargin 100 enheder/ml (såsom Lantus).
English: • If you are being transferred from standard strength insulin to high-strength insulin, your healthcare professional will highlight any differences in design between your high-strength insulin pen and other standard-strength insulin pens.
Danish: • Hvis du skifter fra insulin af sædvanlig styrke til højstyrkeinsulin, vil din sundhedsperson fremhæve eventuelle forskelle mellem pennen med højstyrkeinsulin og penne med insulin af standardstyrke.
English: • The insulin is supplied in a pre-filled pen and it should only be used with this device.
Danish: • Insulinet leveres i en fyldt pen og bør altid kun bruges med pennen.
English: • You must never use a syringe to withdraw insulin from a pre-filled pen otherwise severe overdose may result.
Danish: • Du må aldrig trække insulin op fra en fyldt pen med en sprøjte, da dette kan medføre alvorlige overdosering.
English: • The high-strength insulin is supplied in a pre-filled pen and it should only be used with this device.
Danish: • Højstyrkeinsulinet leveres i en fyldt pen og bør altid kun bruges med pennen.
English: Healthcare professionals must never use a syringe to withdraw insulin from a pre-filled pen otherwise severe overdose can result.
Danish: Sundhedspersoner må aldrig trække insulin op fra en fyldt pen med en sprøjte, da dette kan medføre alvorlig overdosering.
English: • If you are being transferred from standard-strength insulin to a high-strength insulin you will usually be using the same number of units that you were when using the standard-strength insulin.1 This also applies if you are being transferred from a high-strength to a standard-strength insulin.
Danish: • Hvis du skifter fra insulin af sædvanlig styrke til højstyrkeinsulin, skal du normalt have samme antal enheder som da du fik insulin af sædvanlig styrke1.
English: However, there are differences in the way high-strength insulin products are used compared with existing insulin formulations of standardstrength and there is therefore a risk of medication errors and accidental mix-ups.
Danish: Der er dog forskelle i den måde, højstyrkeinsulin anvendes på i forhold til eksisterende insulinformuleringer af sædvanlig styrke.
English: Call your doctor immediately.
Danish: Kontakt straks lægen.
English: Date of first authorisation: 15 May 2009 Date of latest renewal: 15 May 2014
Danish: Dato for første markedsføringstilladelse: 15. maj 2009 Dato for seneste fornyelse: 15. maj 2014
English: No more than 4 patches should be used at the same time.
Danish: Der må ikke anvendes mere end 4 plastre på samme tid.
English: Your doctor or nurse will remove it for you.
Danish: Lægen eller sygeplejersken vil fjerne det for dig.
English: In a small number of cases, these may be signs of a second degree burn and need urgent attention.
Danish: I et mindre antal tilfælde, kan disse være tegn på en andengradsforbrænding og har brug for øjeblikkelig opmærksomhed.
English: Latex gloves should NOT be worn as they do not provide adequate protection.
Danish: Latex-handsker må IKKE anvendes, da de ikke yder tilstrækkelig beskyttelse.
English: • If you feel that your heart is beating too fast, too slow or is beating abnormally.
Danish: • Hvis du føler, at dit hjerte slår for hurtigt, for langsomt eller slår unormalt .
English: This educational programme will include: - recommendations regarding the general handling and disposal measures for Qutenza
Danish: Dette undervisningsprogram skal omfatte: - anbefalinger vedrørende generelle håndterings- og bortskaffelsesforanstaltninger for Qutenza
English: Keep in place for 30 or 60 minutes depending on the location of treatment.
Danish: Lad det sidde på i 30 eller 60 minutter afhængigt af behandlingsstedet.
English: If Qutenza is used longer than it should
Danish: Hvis Qutenza anvendes længere end det burde
English: Do not attempt to remove the patch yourself.
Danish: Forsøg ikke at fjerne plastret selv.
English: Do not touch the patch with your hands.
Danish: Rør ikke ved plastret med hænderne.
English: Tell your doctor if the following side effects occur or get worse:
Danish: Fortæl din læge, hvis de følgende bivirkninger forekommer eller bliver værre:
English: Sensory function
Danish: Sensorisk funktion
English: No data are available following 30-minute treatments.
Danish: Der findes ingen tilgængelige data for 30 minutters behandling.
English: Do not touch your eyes, mouth or other sensitive areas.
Danish: Rør ikke dine øjne, mund eller andre følsomme steder.
English: There is no antidote to capsaicin.
Danish: Der er ingen antidot til capsaicin.
English: Qutenza should be used with caution if you are pregnant.
Danish: Qutenza skal anvendes med forsigtighed, hvis du er gravid.
English: o Frequency not known: frequency cannot be estimated from the available data
Danish: o Ikke kendt hyppighed: hyppigheden kan ikke estimeres ud fra forhåndenværende data
English: For this case a relationship with Qutenza could not be excluded.
Danish: I dette tilfælde kunne en årsagssammenhæng til Qutenza ikke udelukkes.
English: Wait up to 60 minutes, or according to product's instructions for use.
Danish: Vent i op til 60 minutter, eller så lang tid som produktets brugervejledning foreskriver.
English: Supportive measures should be taken as clinically needed.
Danish: Understøttende foranstaltninger skal iværksættes som klinisk indiceret.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske sikkerhedsopdateringer for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: It is unknown whether capsaicin/metabolites are excreted in human milk.
Danish: Det vides ikke, om capsaicin/metabolitter udskilles i human mælk.
English: Unintended exposure
Danish: Utilsigtet eksponering
English: Your doctor will mark the most painful areas on your skin with a pen or marker.
Danish: Lægen vil markere de mest smertefulde områder på din hud med en kuglepen eller tusch.
English: If after that time you still have a lot of pain, please talk to your doctor.
Danish: Hvis du efter den tid stadig har mange smerter, skal du kontakte lægen.
English: Sensations from non TRPV1-expressing cutaneous nerves are expected to remain unaltered, including the ability to detect mechanical and vibratory stimuli.
Danish: Følelser fra ikke-TRPV1-udtrykkende kutane nerver forventes at forblive uændrede, herunder evnen til at opdage mekaniske og vibrerende stimuli.
English: There are no or limited amount of data from the use of capsaicin in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af capsaicin til gravide kvinder.
English: Qutenza contains capsaicin and belongs to a group of medicines called anaesthetics.
Danish: Qutenza indeholder capsaicin og tilhører en gruppe af lægemidler som kaldes anæstetika.
English: • to monitor blood pressure during the treatment procedure
Danish: • at monitorere blodtrykket under behandlingsproceduren
English: Qutenza is not recommended for treatment in patients under 18 years of age.
Danish: Qutenza frarådes til behandling af patienter under 18 år.