FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kevzara have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Kevzara.
English: Kevzara is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints.
Danish: Kevzara er et lægemiddel til behandling af voksne med moderat til svær leddegigt (reumatoid arthritis).
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
Danish: *Relativ styrke bestemt ved en styrketest i mus, som blev sammenlignet med en referencevaccine, der blev påvist at være effektiv hos kvæg.
English: Whereas - The Committee considered the procedure under Article 20 of Regulation (EC) No 726/2004 for
Danish: - Udvalget behandlede proceduren i henhold til artikel 20 af forordning (EF) nr. 726/2004 for
English: • The treatment should be intermittent and not continuous.
Danish: • Behandlingen bør være intermitterende, ikke kontinuerlig
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION
Danish: SAMMENFATNING AF DEN VIDENSKABELIGE EVALUERING
English: • A statement that Protopy should not be used in children under 2 years.
Danish: • En erklæring om, at Protopy ikke bør anvendes hos børn under 2 år
English: However there appeared to be an increase in numbers of patients with CTCL, relative to what would be expected.
Danish: Der synes dog at være et højere antal patienter med CTCL end forventet.
English: The CHMP also expressed concerns about the degree of use of Protopy in children under the age of 2 (not approved) when the immune system is still developing.
Danish: CHMP udtrykte endvidere betænkelighed ved omfanget af anvendelsen af Protopy hos børn under to år (ikke godkendt), hos hvem immunsystemet stadig er under udvikling.
English: This effect is thought to be mediated by the immunosuppression caused as a result of systemic treatment with the product.
Danish: Denne bivirkning antages at være medieret af den immunosuppression, der resulterer af systemisk behandling med produktet.
English: The CHMP endorsed the ongoing registry study presented by the Marketing Authorisation Holder - APPLES study (paediatric registry).
Danish: CHMP godkendte den igangværende registerundersøgelse, der er forelagt af indehaveren af markedsføringstilladelsen - APPLES-undersøgelsen (pædiatrisk register).
English: On 21 April 2005 the European Commission in view of the potential risk of malignancies requested the Opinion of the CHMP on the benefit/risk profile of Protopy.
Danish: På baggrund af den potentielle risiko for maligne lidelser anmodede Europa-Kommissionen den 21. april 2005 CHMP om en udtalelse om benefit/risk profilen af Protopy.
English: Protopy is a dermatological medicinal product that contains the calcineurin inhibitor tacrolimus at a 0.1% and 0.03% concentration.
Danish: Protopy er et dermatologisk lægemiddel, som indeholder calcineurin-hæmmeren tacrolimus i styrkerne 0,1 % og 0,03 %.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR ÆNDRING AF DET AF EMEA FORELAGTE PRODUKTRESUMÉ
English: The mode of action of tacrolimus is stated to be by inhibition of calcium dependent signal transduction pathways in T cells which results in prevention of transcription and synthesis of IL-2, IL3, IL-4, IL-5 and other cytokines.
Danish: Virkningsmekanismen af tacrolimus angives at bestå i hæmning af de calciumafhængige signaltransduktionsveje i T-celler, hvilket fører til hæmning af transkriptionen og syntesen af IL-2, IL-3, IL-4, IL-5 og andre cytokiner.
English: Systemic exposure is limited with the topical use of tacrolimus, however a local immunosuppressive effect in the skin cannot be excluded.
Danish: Den systemiske eksponering er begrænset, når tacrolimus anvendes topikalt, men en lokal immunosuppressiv virkning på huden kan ikke udelukkes.
English: Following this request, the CHMP reviewed the available data on this safety issue, including post-marketing reports, data from nonclinical studies, clinical trials and epidemiological studies.
Danish: På denne anmodning gennemgik CHMP de foreliggende oplysninger om dette sikkerhedsproblem, herunder rapporter over undersøgelser efter markedsføring, oplysninger fra ikke-kliniske forsøg, kliniske forsøg og
English: Therefore the CHMP requested that the MAH should take the appropriate measures in order to ensure that Protopy is not used in this age group.
Danish: CHMP forlangte derfor, at indehaveren af markedsføringstilladelsen tager passende skridt til at sikre, at Protopy ikke anvendes i denne aldersgruppe.
English: After reviewing the available data the CHMP concluded that the balance of risks and benefits for Protopy is considered favourable.
Danish: Efter at have gennemgået de foreliggende oplysninger konkluderede CHMP, at balancen mellem risici og fordele ved Protopy bør anses for gunstig.
English: • Protopy should not be used in immunocompromised adults or children.
Danish: • Protopy bør ikke anvendes hos voksne eller børn med nedsat immunforsvar
English: The data presented did not show a definite association with lymphoma or any malignancy.
Danish: De forelagte oplysninger udviser ingen sikker sammenhæng med lymfom eller andre maligne sygdomme.
English: However, having reviewed the available data, the CHMP concluded that not all cases could be considered to be cases of pre-existing malignancy disease, and an association with tacrolimus could not be excluded in some of the cases.
Danish: Efter at have gennemgået de foreliggende oplysninger konkluderede CHMP imidlertid, at ikke alle tilfældene kan anses for at være forud eksisterende malign sygdom, og at en sammenhæng med tacrolimus i nogle af
English: The CHMP also concluded that the potential role of tacrolimus in the pathogenesis of CTCL should be further investigated through mechanistic studies.
Danish: CHMP konkluderede yderligere, at den potentielle rolle af tacrolimus i patogenesen af CTCL bør undersøges nærmere ved mekanistiske
English: Lymphoma is a recognised and listed adverse effect for systemically administered calcineurin inhibitor products.
Danish: Lymfom er en anerkendt og registreret bivirkning af produkter til systemisk behandling med calcineurin-hæmmere.
English: In addition, the CHMP concluded that further data are required to better elicit the long-term safety of Protopy in respect of its association with malignancies.
Danish: Desuden konkluderede CHMP, at der er brug for flere oplysninger for bedre at få belyst den langsigtede sikkerhed af Protopy hvad angår sammenhængen med ondartede lidelser.
English: • A statement to highlight that tacrolimus should not be applied to lesions, which are considered to be potentially malignant or pre-malignant.
Danish: • En erklæring, hvori det understreges, at tacrolimus ikke må påføres på forandringer, der anses for potentielt maligne eller præmaligne
English: • A warning to advise that any lymphadenopathy present prior to initiation of therapy should be investigated and kept under assessment.
Danish: • En advarsel om, at lymfadenopati, der er til stede inden behandlingens iværksættelse, skal undersøges og løbende kontrolleres
English: The CHMP concluded as well that the risk of cutaneous malignancies should be assessed through case-control studies.
Danish: CHMP konkluderede ligeledes, at risikoen for maligne hudlidelser skal vurderes ved hjælp af case-control undersøgelser.
English: • The treatment with Protopy should only be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Danish: • Behandling med Protopy bør kun iværksættes af læger med erfaring i diagnose og
English: The CHMP requested that the MAH should present 6 monthly updates on the status of recruitment of this study.
Danish: CHMP forlangte, at indehaveren af markedsføringstilladelsen fremlægger 6-måneders interimsrapporter om status af rekrutteringen til denne undersøgelse.
English: - The Committee, as a consequence, concluded that the following information should be included in the Summary of Product Characteristics and relevant sections of the Package Leaflet of
Danish: - Som konsekvens heraf konkluderede udvalget, at følgende oplysninger skal indgå i produktresuméet og i de pågældende afsnit af indlægssedlen til Protopy:
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BEGRUNDELSE FOR ÆNDRINGEN AF PRODUKTRESUMÉET OG INDLÆGSSEDLEN
English: With regard to the skin cancers, the CHMP concluded that treatment with tacrolimus was not likely to have caused these skin malignancies.
Danish: Hvad angår hudkræfttilfældene konkluderede CHMP, at det ikke er sandsynligt, at disse er forårsaget af behandlingen med tacrolimus.
English: As tacrolimus is an effective immunosuppressant that acts by suppressing T lymphocytes in the skin, the CHMP was of the opinion that an effect of tacrolimus on the development or progression of a variety of skin lesions could not be excluded.
Danish: Da tacrolimus er et effektivt immunosuppressivum, der virker ved at undertrykke T-lymfocytterne i huden, kan det efter CHMPs opfattelse ikke udelukkes, at tacrolimus påvirker udviklingen eller progressionen af en række forskellige hudforandringer.
English: Case reports of malignancies (including skin cancer, cutaneous T-Cell lymphoma (CTCL), NonHodking lymphoma (NHL) and systemic malignancies) have been received during the clinical development and post-marketing experience in association with the use of Protopy.
Danish: Der er indkommet case-rapporter om maligne lidelser i forbindelse med brug af Protopy (bestående i hudkræft, kutant T-celle lymfom (CTCL), non-Hodgkin lymfom (NHL) og systemiske maligne sygdomme) under den kliniske udvikling og efter markedsføring.
English: In view of the available data (including pre clinical, clinical and epidemiological) the CHMP concluded that a potential association with the use of Protopy cannot be ruled out and therefore further data are needed to ensure an acceptable
Danish: (prækliniske, kliniske og epidemiologiske) konkluderede CHMP, at man ikke kan udelukke en mulig sammenhæng med brug af Protopy, hvorfor der er brug for flere oplysninger for at sikre,
English: In order to address the safety concerns in relation to the cases of malignancies the CHMP concluded that warnings reflecting the cases of malignancies and the need for monitoring of patients treated with Protopy should be included in the product information.
Danish: Hvad angår de sikkerhedsmæssige betænkeligheder omkring tilfældene af maligne lidelser konkluderede CHMP, at der i produktoplysningerne bør indsættes advarsler, der afspejler tilfældene af maligne lidelser og nødvendigheden af at overvåge patienter, der behandles med Protopy.
English: - The Committee acknowledged that cases of malignancy (including skin cancer and lymphoma) have been reported in patients treated with Protopy.
Danish: - Udvalget tog til efterretning, at der er indberettet tilfælde af maligne lidelser (hudkræft og lymfom) hos patienter behandlet med Protopy På grundlag af de foreliggende oplysninger
English: However, considering that tacrolimus is effective through its suppression of T cells which are involved in immune surveillance, it is possible that tacrolimus could have an effect on the behaviour of cutaneous lesions which were either pre-malignant or cases of early malignancy.
Danish: I betragtning af, at tacrolimus virker gennem suppression af de Tceller, der er involveret i immunovervågningen, kan tacrolimus dog tænkes at påvirke den videre udvikling af hudforandringer, der enten er præmaligne eller er i et tidligt stadium af malignitet.
English: Protopy 0.1% is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults who are not adequately responsive to or are intolerant of conventional therapies and Protopy 0.03% is indicated for the treatment of moderate to severe AD in adults or children (2 years of age and above) who failed to respond adequately to conventional therapies.
Danish: Protopy 0,03 % er indiceret til behandling af moderat til svær atopisk dermatitis hos voksne og børn (fra 2-års alderen), der ikke har reageret tilfredsstillende på traditionelle behandlingsformer.
English: The CHMP has recommended the amendment to the terms of the Marketing Authorisation for Protopy for which the revised Summary of Product Characteristics and Package Leaflet are set out respectively in annexes I and IIIB.
Danish: • En erklæring, der afspejler de tilfælde af maligne lidelser, der er indberettet efter anbefaler CHMP ændring af betingelserne for markedsføringstilladelsen for Protopy, for hvilket revideret produktresumé og indlægsseddel fremgår henholdsvis af bilag I og IIIB.
English: The CHMP agreed that the diagnosis of these skin malignancies is difficult and may mimic AD.
Danish: I CHMP var der enighed om, at diagnosticering af maligne hudlidelser er vanskelig, og at disse kan fremtræde som atopisk dermatitis.
English: In order to reduce the likelihood of mis-diagnosis and in order to better ensure the appropriate use of the medicinal product, the CHMP emphasised that the product information should reflect that the initial diagnosis and initial prescription should be undertaken by physicians with experience in the treatment of AD. Additionally, the CHMP concluded that Protopy should not be used in immunocompromised adults or children and that Protopy should not be applied to lesions that are considered to be potentially malignant or pre-malignant and that lymphadenopathy present at initiation of therapy should be investigated and kept under review.
Danish: For at begrænse sandsynligheden for fejldiagnose og sikre hensigtsmæssig brug af lægemidlet lagde CHMP vægt på, at det af produktoplysningerne fremgår, at indledende diagnose og første ordination bør foretages af læger med erfaring i behandling af atopisk dermatitis.
English: Need help?
Danish: Brug for hjælp?
English: Get medical help immediately.
Danish: Søg straks lægehjælp.
English: Extra items you will need:
Danish: Ekstra ting, du får brug for:
English: But you must use it only if it looks like water.
Danish: Du må kun bruge det, hvis det ser ud som vand.
English: See the section below for help.
Danish: Se punktet nedenfor for hjælp.
English: This is normal, they will not harm you.
Danish: Dette er normalt, og de er ikke farlige for dig.
English: Check your blood sugar.
Danish: Kontrollér dit blodsukker.
English: - Are you exercising more than usual?
Danish: - Dyrker du mere motion end normalt?
English: Read this first
Danish: Læs dette først
English: • Always carry something to show you are diabetic.
Danish: • Medbring altid noget, der viser, at du er diabetiker.
English: • you exercise or work too hard just before or after a meal;
Danish: • du motionerer eller arbejder for hårdt lige før eller efter et måltid;
English: Even when you are not eating normally, you still need insulin.
Danish: Selv når du ikke spiser normalt, har du stadig brug for insulin.
English: This is especially important if you have other injector pens.
Danish: Det er særligt vigtigt, hvis du har andre injektorpenne.
English: Please follow the instructions carefully.
Danish: Følg instruktionerne omhyggeligt.
English: The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.
Danish: Tidsforskellen mellem lande kan betyde, at du skal have dine injektioner og måltider på andre tidspunkter, end når du er hjemme.
English: Ask your doctor to tell you about glucagon.
Danish: Bed din læge fortælle dig om glukagon.
English: Follow them exactly and visit your diabetes clinic regularly.
Danish: Følg dem nøjagtigt og besøg dit diabetesambulatorium regelmæssigt.
English: • Only use your pen for up to 28 days after its first use.
Danish: • Brug kun pennen i op til 28 dage efter første anvendelse.
English: But your doctor will have told you exactly how much to use, when to use it, and how often.
Danish: Din læge har fortalt dig præcist, hvor meget du skal bruge, hvornår du skal bruge det og hvor ofte.
English: The first symptoms come on slowly over many hours or days.
Danish: De første symptomer kommer langsomt over mange timer eller dage.
English: If you do not follow all of these instructions, you may get too much or too little insulin.
Danish: Hvis du ikke følger alle disse instruktioner, risikerer du at få for meget eller for lidt insulin.
English: • there is a change in your need for insulin; or
Danish: • der er en ændring i dit behov for insulin; eller
English: This might just be for the first injection or it may be a gradual change over several weeks or months.
Danish: Dette gælder måske kun den første injektion eller kan være en gradvis ændring over flere uger eller måneder.
English: 21 units selected
Danish: 21 enheder valgt
English: • Ask for help if you have problems handling the pen, for example if you have problems with your sight.
Danish: • Spørg om hjælp, hvis du har problemer med at håndtere pennen, for eksempel hvis du har problemer med synet.
English: Alcohol and some medicines can affect your blood sugar levels (see section 2).
Danish: Alkohol og visse lægemidler kan påvirke dit blodsukkerniveau (se punkt 2).
English: Each pen contains more than one dose.
Danish: Hver pen indeholder mere end én dosis.
English: If your dose is more than 80 units, you will need to give yourself more than one injection.
Danish: Hvis din dosis er højere end 80 enheder, er du nødt til at give dig selv mere end en indsprøjtning.
English: This can be caused if:
Danish: Dette kan skyldes, at:
English: Patients must be educated to use the proper injection techniques.
Danish: Patienter skal undervises i at bruge korrekte injektionsteknikker.
English: Severe cases of generalised allergy may be life-threatening.
Danish: Alvorlige tilfælde af generaliseret allergi kan være livstruende.
English: • rash over the whole body
Danish: • udslæt over hele kroppen
English: This may damage your pen.
Danish: Dette kan beskadige pennen.
English: Common problems of diabetes
Danish: Almindelige problemer ved diabetes
English: Use a new pen.
Danish: Brug en ny pen.
English: • You may need to repeat this step up to 3 times before seeing insulin.
Danish: • Det kan være nødvendigt at gentage dette trin op til 3 gange, inden insulinen kommer ud.
English: However, a consistent routine must be followed.
Danish: En ensartet rutine bør indarbejdes.
English: • angiotensin II receptor blockers.
Danish: • angiotensin II-receptorblokkere.
English: The patient should be given a meal as soon as consciousness is recovered.
Danish: Patienten bør have noget at spise, så snart han/hun kommer til bevidsthed.
English: • Always carry sugar with you.
Danish: • Hav altid sukker på dig.
English: • eating a lot more than your diet allows; or
Danish: • at du spiser mere, end din diæt tillader dig; eller
English: Protect your pen from dust and dirt
Danish: Beskyt din pen mod støv og snavs
English: The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (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: cannot be estimated from the available data).
Danish: Følgende bivirkninger fra kliniske studier er anført nedenfor efter systemorganklasse og faldende hyppighed (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: The number of units are displayed in the dose window, always check this before your injection.
Danish: Antal enheder er synligt i doseringsvinduet, tjek derfor altid dette inden din indsprøjtning.
English: If you find it hard to press the button in:
Danish: Hvis du har svært ved at trykke knappen ind:
English: STEP 3: Do a safety test
Danish: TRIN 3: Udfør en sikkerhedstest
English: • you have an infection or illness (especially diarrhoea or vomiting);
Danish: • du har en infektion, eller du er syg (specielt diarré eller opkastning);
English: Severe symptoms are heavy breathing and a rapid pulse.
Danish: Alvorlige symptomer er tung vejrtrækning og hurtig puls.
English: • fever, infection or emotional stress.
Danish: • feber, infektion eller følelsesmæssig ubalance.
English: DC5, Campona utca 1., Budapest, 1225, Hungary
Danish: DC5, Campona utca 1., Budapest, 1225
English: Warning signs are listed later in this leaflet.
Danish: Advarselssymptomer beskrives senere i denne indlægsseddel.
English: Patients with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy.
Danish: Diabetikere bør rådes til at oplyse deres læge om, hvorvidt de er gravide eller overvejer graviditet.
English: Dispose of after 4 weeks.
Danish: Kasseres efter 4 uger.
English: Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin.
Danish: Systemisk allergi, som er sjælden, men potentielt mere alvorlig, er en generaliseret overfølsomhed over for insulin.
English: The typical activity profile following subcutaneous injection is illustrated below.
Danish: Den typiske virkningsprofil efter subkutan injektion illustreres nedenfor.
English: • If no insulin comes out after the third time, the needle may be blocked.
Danish: • Hvis der ikke kommer insulin ud efter den tredje gang, kan nålen være tilstoppet.
English: Insulin requirements usually fall during the first trimester and increase during the second and third trimesters.
Danish: Insulinbehovet nedsættes sædvanligvis under første trimester og øges under andet og tredje trimester.
English: For single patient use only.
Danish: Må kun anvendes til en enkelt patient.
English: • If you turn past your dose, you can turn back down.
Danish: • Hvis du drejer forbi din dosis, kan du dreje tilbage igen.
English: • no appetite
Danish: • manglende appetit
English: Never use your pen if it is damaged or if you are not sure that it is working properly.
Danish: Brug aldrig pennen, hvis den er beskadiget, eller hvis du er usikker på, om den virker som den skal.
English: A Make sure a needle is attached and the dose is set to ‘0'.
Danish: A Sørg for, at en nål er påsat, og at dosis er indstillet til “0”.
English: METHOD OF ADMINISTRATION Use specific pens.
Danish: ADMINISTRATIONSMETODE Brug bestemte penne.
English: Do not overtighten.
Danish: Må ikke overspændes.
English: The symptoms include the following:
Danish: Symptomerne inkluderer følgende:
English: If no insulin appears:
Danish: Hvis der ikke kommer insulin ud:
English: You should contact your doctor about the advisability of driving if you have:
Danish: Du bør drøfte med din læge om bilkørsel er tilrådeligt, hvis du har:
English: Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
Danish: Patienter, der er blinde eller svagtseende, skal instrueres til altid at modtage hjælp/assistance fra en person, som har et godt syn og som er trænet i brug af insulinpennen.
English: Acute, one month and twelve month toxicology studies produced no significant toxicity findings.
Danish: Akutte, 1 måneds og 12 måneders toksikologistudier viste ingen væsentlig toksicitet.
English: Store below 30°C and protect from direct heat and light.
Danish: Opbevares ved temperaturer under 30°C og skal beskyttes mod direkte varme og lys.
English: This helps stop blocked needles, contamination and infection.
Danish: Dette hjælper med at forebygge blokerede nåle, kontaminering og infektion.
English: A Check the name and expiration date on the label of your pen.
Danish: A Kontroller navnet og udløbsdatoen på etiketten på din pen.
English: Then remove the needle from your skin.
Danish: Fjern derefter nålen fra huden.