FrancophonIA/ELRC3.0 huggingface dataset:
English: Animal studies are insufficient with respect to developmental toxicity (see section 5.3).
Danish: Data fra dyreforsøg er utilstrækkelige hvad angår udviklingstoksicitet (se pkt.
English: The adverse reactions reported during clinical trials conducted with afamelanotide are listed in the table below by MedDRA system organ class and frequency convention.
Danish: De indberettede bivirkninger i kliniske undersøgelser med afamelanotid er anført i nedenstående tabel, inddelt efter MedDRA-systemorganklasse og -hyppighed.
English: Poly (DL-lactide-co-glycolide)
Danish: Poly(DL-lactid-co-glycolid)
English: - Disinfect the skin above the supra-iliac crest.
Danish: - Desinficer huden over crista iliaca superior.
English: EPP is a condition in which patients have an increased sensitivity to sunlight, which can cause toxic effects such as pain and burning.
Danish: EPP er en sygdom med øget følsomhed for sollys, som kan medføre skadevirkninger i form af smerter og skoldning.
English: Decreased appetite Hypercholesterolaemia Increased appetite
Danish: Hyperkolesterolæmi Øget appetit
English: The most commonly reported adverse reactions are nausea, experienced by approximately 19% of subjects who received treatment with this medicinal product, headache (20%), and implant site reactions (21%; mainly discolouration, pain, haematoma, erythema).
Danish: De hyppigst indberettede bivirkninger er kvalme, der forekommer hos ca. 19 % af de behandlede, hovedpine (20 %) og reaktioner på implantationsstedet (21 %, hovedsagelig affarvning, smerter, hæmatom og erytem).
English: Instruction for use
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: Afamelanotide works in a way similar to the natural hormone, by making skin cells produce eumelanin which is a brown-black type of melanin pigment in the body.
Danish: Afamelanotid virker ligesom det naturlige hormon ved at få hudcellerne til at producere eumelanin, som er et sortbrunt melaninpigment i kroppen.
English: The implant is given as injection under your skin using a catheter tube and needle (subcutaneous use).
Danish: Implantatet gives som en injektion under huden ved hjælp af en kateterslange og en kanyle (subkutan anvendelse).
English: This is because patients taking such medicines may experience increased bruising or bleeding at the site of the implant.
Danish: Grunden er, at sådanne lægemidler kan øge forekomsten af blå mærker eller blødning på implantationsstedet.
English: The recommended maximum number of implants is four per year.
Danish: Der anbefales maksimalt fire implantater årligt.
English: SCENESSE is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Danish: SCENESSE er indiceret til forebyggelse af fototoksicitet hos voksne med erythropoietisk protoporfyri (EPP).
English: There are no clinical data on the effects of afamelanotide on fertility.
Danish: Der foreligger ingen kliniske data om virkningerne af afamelanotid på fertiliteten.
English: The requirements for submission of PSURs 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: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af PSUR´er 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 Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: SCENESSE should only be prescribed by specialist physicians in recognised porphyria centres and administration should be performed by a physician trained and accredited by the marketing authorisation holder to administer the implant.
Danish: SCENESSE bør kun ordineres af speciallæger på afdelinger, der er specialiseret i porfyri, og bør administreres af en læge, som af indehaveren af markedsføringstilladelsen har modtaget instruktion i og autorisation til at administrere implantatet.
English: E. SPECIFIC OBLIGATIONS TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures: Description
Danish: Dette er en godkendelse under særlige vilkår, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Store in a refrigerator (2oC - 8oC).
Danish: Opbevares i køleskab (2º - 8º C).
English: Afamelanotide is a melanocortin receptor agonist and binds predominantly to the melanocortin-1 receptor (MC1R).
Danish: Afamelanotid er en melanocortinreceptor-agonist, der hovedsagelig bindes til melanocortin1-receptoren (MC1R).
English: - The active substance is afamelanotide.
Danish: - Aktivt stof: afamelanotid.
English: - Transfer the implant to the outlet of the catheter.
Danish: - Overfør implantatet til kateterets afgang.
English: Aspartate aminotransferase increased
Danish: Aspartataminotransferase forhøjet
English: - Apply a small pressure dressing to the injection site.
Danish: - Læg et let tryk på indstiksstedet.
English: The overall duration of treatment is at the specialist physician's discretion (see section 4.4).
Danish: Den samlede behandlingsvarighed fastsættes af speciallægen (se pkt.
English: A study in Sprague-Dawley rats showed no adverse effects on embryo-fetal development at exposures approximately 135-fold the human exposure (based on Cmax).
Danish: I en undersøgelse hos Sprague-Dawley rotter sås ingen negative virkninger på den embryoføtale udvikling ved ca. 135 gange den humane eksponering (baseret på Cmax).
English: Blood creatine phosphokinase increased
Danish: Kreatinfosfokinase i blodet forhøjet
English: - The other ingredient is poly (D,L-lactide-co-glycolide).
Danish: - Øvrige indholdsstoffer: poly(D,L-lactid-co-glycolid).
English: Other medicines and SCENESSE
Danish: Brug af anden medicin sammen med SCENESSE
English: If the skin changes noted are consistent with skin cancer or its precursors, or are ambiguous to the porphyria specialist, dermatology specialist consultation should be sought.
Danish: Ved hudforandringer, som er forenelige med hudkræft eller forstadier dertil eller af porfyrispecialisten anses for tvivlsomme, bør der søges speciallæge.
English: The MAH shall also agree the details of the controlled access programme to ensure distribution of SCENESSE only to centres where the physicians received the educational materials and have been trained.
Danish: Indehaveren af markedsføringstilladelsen skal desuden træffe aftale om detaljerne i programmet for adgangskontrol, der sikrer, at SCENESSE kun distribueres til behandlingscentre, hvor lægerne har modtaget uddannelsesmaterialet og instruktion.
English: In a fertility study no effects on the reproductive function of male or female Sprague-Dawley rats were observed after subcutaneous application of afamelanotide.
Danish: I en fertilitetsundersøgelse iagttoges ingen virkninger på reproduktionen hos Sprague-Dawley rotter uanset køn efter subkutan administration af afamelanotid.
English: Disease registry
Danish: Sygdomsregister
English: Administration should be performed by a physician trained and accredited by the marketing authorisation holder to administer the implant.
Danish: Administrationen skal foretages af en læge, der af indehaveren af markedsføringstilladelsen har modtaget instruktion og autorisation til at administrere implantatet.
English: The implant may be removed by a simple surgical procedure if needed.
Danish: Om nødvendigt kan implantatet fjernes ved et simpelt operativt indgreb.
English: Due to limited data in treatment of elderly patients, the use of afamelanotide is not recommended (see section 4.4).
Danish: Da der er begrænsede data fra behandling af ældre patienter, bør afamelanotid ikke anvendes (se pkt.
English: - Wound complication, open wound
Danish: - Sårkomplikationer, åbent sår
English: There are no or limited amounts of data from the use of afamelanotide in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af afamelanotid til gravide kvinder.
English: Afamelanotide may induce darkening of pre-existing pigmentary lesions due to its pharmacological effect.
Danish: Afamelanotid kan medføre, at eksisterende pigmentforandringer bliver mørkere på grund af stoffets farmakologiske virkning.
English: - Palpitations, fast heart rate, bruising, high blood pressure, difficulty to make some sounds
Danish: - Hjertebanken, hurtig hjerterytme, blå mærker, højt blodtryk, besvær med at udtale visse lyde
English: What SCENESSE contains
Danish: SCENESSE indeholder:
English: However, this number should not exceed more than 4 per year.
Danish: Der kan dog ikke gives mere end 4 implantater om året.
English: If the implant has not been administered during the procedural steps described above, discard the implant and administer a new implant.
Danish: Hvis det ikke er lykkedes at indsætte implantatet ved ovenstående fremgangsmåde, skal implantatet kasseres, og et nyt implantat ilægges.
English: Patients taking substances which reduce coagulation, such as vitamin K antagonists (e.g. warfarin), acetylsalicylic acid and non-steroidal anti-inflammatory drug (NSAIDs) may experience increased bruising or bleeding at the site of implantation.
Danish: Patienter, som får antikoagulantia såsom vitamin K-antagonister (f.eks. warfarin), acetylsalicylsyre eller nonsteroide antiinflammatoriske lægemidler (NSAID), kan lettere få blå mærker eller blødning på implantationsstedet.
English: Over time the implant will be absorbed by the body, this will happen within 50 to 60 days after implantation.
Danish: Dette vil tage mellem 50 og 60 dage efter implantationen.
English: - Using a suitable device (such as a stylet) gently push the implant down the full length of the catheter lumen.
Danish: - Skub med et passende redskab (såsom en stilet) implantatet helt ind gennem kateterets lumen i dettes fulde længde.
English: - Confirm insertion of the implant by palpating the skin with subcutis cranial to/overlying the suprailiac crest until the implant is located.
Danish: - Kontrollér, at implantatet er på plads, ved at palpere huden og subcutis kranialt for/over crista iliaca superior, indtil implantatet er lokaliseret.
English: Clinically significant disorders of the gastrointestinal, cardiovascular, respiratory, endocrine (including diabetes, Cushing's disease, Addison's disease, Peutz-Jeghers syndrome), neurological (including seizures) and haematological (especially anaemia) systems have not been evaluated.
Danish: Der er ikke vurderet klinisk betydningsfulde sygdomme af gastrointestinal, kardiovaskulær, respiratorisk, endokrin (diabetes, Cushings sygdom, Addisons sygdom, Peutz-Jeghers syndrom), neurologisk (herunder kramper) eller hæmatologisk (specielt anæmi) art.
English: Afamelanotide is a synthetic tridecapeptide and a structural analogue of α-melanocyte stimulating hormone (α-MSH).
Danish: Afamelanotid er et syntetisk tridekapeptid og en strukturel analog til α-melanocytstimulerende hormon (α-MSH).
English: - Decrease white blood cells, abnormal liver function tests, decreased iron binding, increased cholesterol, increased sugar level, decreased blood iron level, increased blood pressure, blood in urine
Danish: - Nedsat antal hvide blodlegemer, abnorme leverfunktionsprøver, nedsat jernbinding, forhøjet kolesterol, forhøjet blodsukker, nedsat jernindhold i blodet, forhøjet blodtryk, blod i urinen
English: If you experience discomfort and are concerned, speak to your doctor.
Danish: Hvis du mærker ubehag og er bekymret, skal du kontakte lægen.
English: - Swollen eye lids, red eyes, dry eye, difficulty focusing on close objects, ringing in ears
Danish: - Hævede øjenlåg, røde øjne, tørre øjne, besvær med at se skarpt tæt på, ringen for ørerne
English: • Registry information sheet.
Danish: • oplysningsblad til register.
English: Pigmentation lip Post inflammatory pigmentation change Seborrhoea
Danish: Pigmentering af læber Postinflammatorisk pigmentændring Seborré
English: SPECIFIC OBLIGATIONS TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: E. SÆRLIGE FORPLIGTELSER TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE OMSTÆNDIGHEDER
English: The implant will be inserted by a doctor who has been trained in the administration procedure.
Danish: Implantatet vil blive indsat af en læge, som har fået instruktion i at indsætte det.
English: - With the bevel of the needle facing upwards, insert the catheter laterally 1.5 to 2 cm into the subcutaneous layer at a 30 to 45 degree angle to the skin surface in one continuous flowing movement.
Danish: - Vend kanylens skråtskårne del opad, hold kateteret i en vinkel på 30-45 grader med hudoverfladen, og før kateteret lateralt 1,5-2 cm ind i subcutis i én uafbrudt bevægelse.
English: - With the catheter in place, aseptically remove the implant from the vial.
Danish: - Når kateteret er på plads, udtages implantatet aseptisk fra hætteglasset.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION The implant contains 16 mg of afamelanotide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Implantatet indeholder 16 mg afamelanotid.
English: Women who could become pregnant should use adequate contraception such as oral contraceptives, diaphragm plus spermicide, intrauterine device (also known as a coil) during treatment and for three months after the last SCENESSE implantation.
Danish: Kvinder, der kan blive gravide, bør bruge sikker prævention såsom p-piller, pessar plus sæddræbende creme eller spiral under behandlingen og tre måneder efter at have fået det sidste SCENESSEimplantat.
English: Solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter.
Danish: Massiv, hvid til let gullig stav, længde 1,7 cm og 1,5 mm i diameter.
English: Talk to your doctor before receiving SCENESSE if you have or have ever had: - heart problems or severe breathing problems; - gastrointestinal problems; - diabetes;
Danish: Kontakt lægen, før du får SCENESSE, hvis du har eller nogensinde har haft: - hjerteproblemer eller svært vejrtrækningsbesvær, - mave-tarm-problemer, - sukkersyge, - Cushings sygdom (en hormonsygdom, hvor kroppen producerer for meget af hormonet kortisol),
English: Arrange for an early appointment with your porphyria specialist if pigmented lesions like moles grow or if other growing, non-healing, weeping, plaque-like, wart-like, or ulcerated lesions appear.
Danish: Få snarest en konsultation hos en speciallæge i porfyri, hvis stærkt farvede forandringer som modermærker begynder at vokse, eller hvis der viser sig andre væskende, forhøjede, vortelignende eller sårfyldte forandringer, der ikke vil heles og vokser.
English: The implant is a solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter in an amber glass vial sealed with a PTFE coated rubber stopper.
Danish: Implantatet er en massiv, hvid til let gullig stav, der måler 1,7 cm i længden og 1,5 mm i diameter, i et gult hætteglas af glas med PTFE-belagt gummiprop.
English: - Infected hair follicle, fungal infection, urinary tract infection
Danish: - Betændelse i hårsække, svampeinfektioner, urinvejsinfektioner
English: 6.6 Special precautions for disposal and other handling For instructions on correct administration and preparation see section 4.2.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Se pkt.
English: These may include warfarin, acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever or to prevent blood clotting) and a group of medicines called non-steroidal antiinflammatory drug (NSAIDs), used to treat common ailments, such as arthritis, headaches, mild fever, rheumatism and sore throats.
Danish: Sådanne lægemidler kan være warfarin, acetylsalicylsyre (et stof, der findes i mange smertestillende og febernedsættende lægemidler og også er blodpropforebyggende) samt nonsteroide antiinflammatoriske lægemidler (NSAID), der bruges mod almindelige lidelser såsom gigt, hovedpine, let feber, reumatisme og ondt i halsen.
English: Pack of one vial containing one implant.
Danish: Pakningen indeholder ét hætteglas med ét implantat.
English: One implant contains 16 mg of afamelanotide.
Danish: Et implantat indeholder 16 mg afamelanotid.
English: It is recommended that sun protection measures routinely adopted by each patient to manage their photosensitivity related to EPP and in accordance with their skin type (Fitzpatrick scale) are maintained during treatment with this medicinal product.
Danish: Under behandlingen med dette lægemiddel anbefales det, at patienten fortsætter med sin sædvanlige solbeskyttelse mod sin EPP-betingede fotosensitivitet i overensstemmelse med sin hudtype (Fitzpatrick-skalaen).
English: Inflammation was observed in the Harderian gland in the rat.
Danish: Der iagttoges inflammation af Harders kirtel hos rotter.
English: - Mark 1.5 to 2 cm on the catheter shaft using surgical ink.
Danish: - Markér dybden 1,5 til 2 cm på kateterskaftet med en kirurgisk mærkepen.
English: Abdominal pain Abdominal pain upper Diarrhoea
Danish: Abdominalsmerter Øvre abdominalsmerter Diarré
English: LIST OF EXCIPIENTS Poly (DL-lactide-co-glycolide).
Danish: LISTE OVER HJÆLPESTOFFER Poly(DL-lactid-co-glycolid)
English: Abdominal symptom Bowel movement irregularity Flatulence
Danish: Abdominale symptomer Uregelmæssig afføring Flatulens
English: Skin exfoliation Skin hypopigmentation Hair colour changes Hyperhidrosis
Danish: Hudeksfoliation Hypopigmentering af hud Ændret hårfarve Hyperhidrose
English: • Summary of product characteristics,
Danish: • produktresumé,
English: - Depression, inability to sleep, poor quality sleep, fainting, fainting sensation, fall, hangover, weakness, inability to get legs comfortable, increased sensitivity to touch, headache following injury, burning sensation, abnormal taste sensation
Danish: - Depression, søvnbesvær, dårlig søvnkvalitet, besvimelse, følelse af at ville besvime, fald, tømmermænd, svaghed, ubehag i benene, øget berøringsfølsomhed, hovedpine efter skader, brændende fornemmelse, abnorme smagsindtryk
English: Type I amber glass vial sealed with a PTFE coated rubber stopper.
Danish: Gult hætteglas type I med PTFE-coatet gummiprop.
English: Restless leg syndrome Hyperaesthesia Presyncope
Danish: Restless Legs Syndrom Hyperæstesi
English: Blood cholesterol increased Blood glucose increased Blood iron decreased Blood pressure diastolic increased
Danish: Transaminaser forhøjet Transferrinmætning nedsat Kolesterol i blodet forhøjet Blodsukker forhøjet Jernindhold i blodet nedsat Diastolisk blodtryksforhøjelse Blod i urinen
English: No clinical data are available on the use of afamelanotide in breastfeeding women.
Danish: Der foreligger ingen kliniske data om anvendelse af afamelanotid hos ammende kvinder.
English: Depression Depressed mood Insomnia
Danish: Depression Nedsat stemningsleje Søvnløshed
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Subcutaneous use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug
English: • Methods to prevent or minimise application errors and application site reactions Registry information sheet shall contain the following key messages:
Danish: • metoder til forebyggelse eller minimering af fejl ved implantationen og reaktioner på implantationsstedet.
English: - if you are allergic to afamelanotide or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for afamelanotid eller et af de øvrige indholdsstoffer i SCENESSE
English: Since available data in treatment of the elderly are limited, afamelanotide should not be used in patients over 70 years of age.
Danish: Afamelanotid bør ikke anvendes hos patienter over 70 år, da der kun foreligger begrænsede data om behandling af ældre.
English: • Face to face training material,
Danish: • materiale til direkte personlig instruktion,
English: - Heavy and prolonged period, abnormal period, breast tenderness, irregular periods, discharge from vagina, decreased sex drive
Danish: - Generende og langstrakt menstruation, abnorm menstruation, ømme bryster, uregelmæssig menstruation, udflåd fra skeden, nedsat sexlyst
English: - Cushing's disease (a hormone disorder where the body produces too much of the hormone cortisol); - Addison's disease (a disorder of the adrenal glands causing a lack of some hormones); - Peutz-Jeghers syndrome (a disorder that causes blockage of the bowel and where your hands, soles of your feet and surface of your lips may have brown freckles); - epilepsy (or have been told that you are at risk of having fits); - anaemia (low counts of red blood cells in your blood); - melanoma (an aggressive type of skin cancer), including in-situ melanoma, e.g. lentigo maligna; or if you have certain inherited conditions that increase the risk of developing a melanoma; - skin cancer of the types, basal cell carcinoma or squamous cell carcinoma (inclusive of carcinoma in situ, e.g. Bowen's disease), Merkel cell carcinoma or other malignant or premalignant skin problems.
Danish: - Addisons sygdom (en sygdom i binyrerne, der medfører mangel på visse hormoner), - Peutz-Jeghers syndrom (en sygdom, der medfører blokering af tarmen, og hvor der kan være fregner på hænder, fodsåler og læber), - epilepsi (eller hvis du har fået at vide, at du kan få krampeanfald), - for lavt antal røde blodlegemer (anæmi), - modermærkekræft (melanom, en aggressiv form for hudkræft), herunder in situ melanom, f.eks.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each implant contains 16 mg afamelanotide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert implantat indeholder 16 mg afamelanotid.
English: - Pain, swelling around site of implantation, bruising at injection site, irritation at injection site, enlargement at implant site, itching at implant site, implant falling out, change in colour of skin at implant site
Danish: - Smerter, hævelse omkring implantationsstedet, blå mærker på indstiksstedet, irritation på indstiksstedet, opsvulmning på implantationsstedet, kløe på implantationsstedet, implantatet falder ud, ændret hudfarve på implantationsstedet
English: Implant site oedema Pyrexia
Danish: Ødem på implantationsstedet Pyreksi
English: Patients should not drive or use machines in case they are affected by these symptoms.
Danish: Ved sådanne symptomer må patienten ikke føre motorkøretøj eller betjene maskiner.
English: Implant site hypersensitivity Implant site reaction Implant site pain Implant site haematoma Implant site erythema Implant site irritation Asthenia
Danish: Hypersensitivitet på implantationsstedet Reaktion på implantationsstedet Smerter på implantationsstedet Hæmatom på implantationsstedet Erytem på implantationsstedet Irritation på implantationsstedet Asteni
English: - Irregularity of skin, rash with small blisters, itch, rash, red rash, red swelling on skin, rash with small bumps, itchy rash, skin irritation, lighter skin patches, acne, eczema, secretions on skin, skin peeling, skin with loss of colour, hair colour changes, excessive sweating
Danish: - Ujævn hud, udslæt med små blærer, kløe, udslæt, rødt udslæt, rød, hævet hud, udslæt med små knopper, kløende udslæt, hudirritation, områder med lysere hud, akne, eksem, væskende hud, afskalning af huden, farveløs hud, ændret hårfarve, svedtendens
English: Afamelanotide is a synthetic form of a body hormone called alpha-melanocyte stimulating hormone (α-MSH).
Danish: Afamelanotid er en syntetisk form af kroppens naturlige α-melanocytstimulerende hormon (α-MSH).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SCENESSE 16 mg implant afamelanotide
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) SCENESSE, implantat, 16 mg afamelanotid