natgillin/translations-raw huggingface dataset:
På grund af indholdet af kortikosteroid er Daivobet gel kontraindiceret ved følgende lidelser: Hudinfektioner forårsaget af virus (fx herpes eller varicella), svampe- eller bakterieinfektioner i huden, infektioner forårsaget af parasitter, hudsygdomme relateret til tuberkulose eller syfilis, perioral dermatitis, hudatrofi, striae atrophicae, skørhed i hudens kar, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcerationer og sår, perianal og genital kløe.
Due to the content of corticosteroid, Daivobet gel is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds, perianal and genital pruritus.
På grund af indholdet af kortikosteroid er Daivobet salve kontraindiceret ved følgende lidelser: Hudinfektioner forårsaget af virus (fx herpes eller varicella), svampe- eller bakterieinfektioner i huden, infektioner forårsaget af parasitter, hudsygdomme relateret til tuberkulose eller syfilis, perioral dermatitis, hudatrofi, striae atrophicae, skørhed i hudens kar, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcerationer og sår, perianal og genital kløe.
Due to the content of corticosteroid Daivobet ointment is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds, perianal and genital pruritus.
Hvis du vil have yderligere oplysninger om Daivobet, skal du henvende dig til den lokale repræsentant: [Udfyldes nationalt]
For further information about this medicine, contact the local representative of the Marketing Authorisation Holder [To be completed nationally]
50 microgram/g + 0,5 mg/g, zalf
Dovobet 50 microgram/g + 0,5 mg/g, zalf
Ordlyden i de nationale produktresuméer var i vid udstrækning afspejlet i det gensidigt anerkendte produktresumé.
The wording in the national SPCs was largely reflected in the MRP SPC.
Daivobet salve, produktresumé: “Topisk behandling af stabil plaque-psoriasis vulgaris, der er egnet til topisk behandling hos voksne”.
In conclusion, the CHMP endorsed the following wording under this section: Daivobet ointment SPC: “Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy in adults”.
50 μg/g + 0,5 mg/g
50 µg/g + 0.5 mg/g
Topisk behandling af mild til moderat plaque-psoriasis vulgaris, der optræder andre steder end i hovedbunden, hos voksne”.
Topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults”.
Daivobet gel virker bedst, hvis du ikke går i bad lige efter, du har påsmurt den. - Undgå kontakt med tekstiler, der let tager imod fedtpletter (fx silke), når du har smurt gelen på.
- In order to achieve optimal effect, it is recommended not to take a shower or bath immediately after application of Daivobet ointment - After applying the ointment avoid contact with textiles which are easily stained by grease (e.g. silk).
Ordlyden i flere medlemsstaters nationale produktresuméer var i vid udstrækning afspejlet i det gensidigt anerkendte produktresumé.
The wording in the national SPCs of several MS largely was reflected in MRP SPC.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et gram gel indeholder 50 mikrogram calcipotriol (som monohydrat) og 0,5 mg betamethason (som dipropionat).
QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Et gram gel indeholder 50 mikrogram calcipotriol (som monohydrat) og 0,5 mg betamethason (som dipropionat).
One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Du må IKKE bruge gelen på hud angrebet af: - betændelse forårsaget af virus (fx forkølelsessår eller skoldkopper) - betændelse forårsaget af svampe (fx fodsvamp eller ringorm) - betændelse forårsaget af bakterier - betændelse forårsaget af parasitter (fx fnat/scabies) - tuberkulose (TB) eller syfilis - perioral dermatitis (rødt udslæt omkring munden) - tynd hud, skørhed i hudens kar, strækmærker - ichthyosis (tør hud med fiskeskællignende afskalning) - acne (bumser) - rosacea (alvorlig blussen eller rødme i ansigtet) - sår eller beskadiget hud - kløe omkring endetarmen eller kønsdelene
As Daivobet contains a strong steroid do NOT use on skin affected by - infections caused by viruses (e.g. cold sores or chicken pox) - infections caused by a fungus (e.g. athlete's foot or ringworm) - infections caused by bacteria - infections caused by parasites (e.g. scabies) - tuberculosis (TB) or syphilis - perioral dermatitis (red rash around the mouth) - thin skin, easily damaged veins, stretch marks - ichthyosis (dry skin with fish-like scales) - acne (pimples) - rosacea (severe flushing or redness of the skin on the face) - ulcers or broken skin - itching of the anus (back passage) or genitals (sex organs).
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et gram salve indeholder 50 mikrogram calcipotriol (som monohydrat) og 0,5 mg betamethason (som dipropionat)
QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
Pakningsstørrelser: 15 g, 30 g, 60 g, 100 g og 120 g.
Daivobet ointment in tubes of 15 g, 30 g, 60 g, 100 g or 120 g
Påfør Daivobet på de angrebne steder med fingerspidserne og gnid den forsigtigt ind. - Normalt er 1-4 g om dagen nok til behandling af hårbunden (4 g svarer til en teskefuld).
Apply Daivobet to the affected area with your fingertips, and rub it in gently - For treatment of the scalp usually an amount between 1 g and 4 g per day is sufficient (4 g corresponds to one teaspoon) - Washing your hair before application of Daivobet is not necessary - In order to achieve optimal effect, it is recommended that the hair is not washed immediately after application of Daivobet.
Daivobet og tilhørende navne (se bilag I) 50 mikrogram/0,5 mg/g gel [Se bilag I - Udfyldes nationalt] calcipotriol/betamethason
Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g gel [See Annex I - To be completed nationally] calcipotriol/betamethasone
Et gram salve indeholder 50 mikrogram calcipotriol (som monohydrat) og 0,5 mg betamethason (som dipropionat).
One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
50 microgram/g + 0.5 mg/g ointment
Dovobet 50 microgram/g + 0.5 mg/g ointment
50 míkrógrömm/0,5 mg/g hlaup
Daivobet 50 míkrógrömm/0 ,5 mg/g hlaup
Kroppens samlede areal behandlet med calcipotriol bør ikke overstige 30 % (se pkt.
When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30 % (see section 4.4).
Opbevar flasken i yderkartonen beskyttet mod lys.
Keep the bottle in the outer carton in order to protect from light - Discard the bottle with any remaining gel 3 months after first opening.
Daivobet og tilhørende navne (se bilag I) 50 mikrogram/0,5 mg/g gel [Se bilag I - Udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g gel [See Annex I - To be completed nationally]
Topikal behandling af mild til moderat plaque psoriasis på resten af kroppen hos voksne.
Topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults.
Daivobet og tilhørende navne (se bilag I) 50 mikrogram/0,5 mg/g salve [Se bilag I - Udfyldes nationalt] calcipotriol/betamethason
Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g ointment [See Annex I - To be completed nationally] Calcipotriol/betamethasone
Brugen af Daivobet gel én gang dagligt blev sammenlignet med Daivonex kutanopløsning til hårbunden to gange dagligt i op til 8 uger.
Another randomised, investigator-blinded clinical study including 312 patients with scalp psoriasis of at least moderate severity according to the IGA investigated use of Daivobet gel once daily compared with Daivonex Scalp solution twice daily for up to 8 weeks.
Polyoxypropylen-15-stearylether Ricinusolie, hydrogeneret Butylhydroxytoluen (E321)
Polyoxypropylene-15 stearyl ether Castor oil, hydrogenated Butylhydroxytoluene (E321) All-rac-α-tocopherol
Daivobet ointment 50 μg/g + 0,5 mg/g
DAIVOBET 50 µg/g + 0.5 mg/g
Hvis du får en allergisk reaktion, skal du stoppe behandlingen med Daivobet og øjeblikkeligt kontakte din læge eller tage på nærmeste skadestue.
If you have an allergic reaction, stop taking Daivobet, tell your doctor immediately or go to the casualty department at your nearest hospital - Treatment with this ointment may cause the level of calcium in your blood or urine to increase (usually when too much ointment has been used).
50 microgram/g + 0.5 mg/g
Dovobet 50 microgram/g + 0.5 mg/g
Udslæt
Pruritus
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et gram gel indeholder 50 mikrogram calcipotriol (som monohydrat) og 0,5 mg betamethason (som dipropionat).
STATEMENT OF ACTIVE SUBSTANCE(S) One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Storbritannien LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
United Kingdom LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
Polyoxypropylen-15-stearylether all-rac-α-tocopherol
Polyoxypropylene-15 stearyl ether
Daivobet og tilhørende navne (se bilag I) 50 mikrogram/0,5 mg/g salve [Se bilag I - Udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g ointment [See Annex I - To be completed nationally]
Meget almindelig Almindelig
Very common ≥1/10 Common
Daivobet salve
DAIVOBET OINTMENT
DAIVOBET SALVE
Daivobet ointment
- Tør hud - Udslæt som følge af, at huden er blevet lysfølsom - Eksem.
Less serious side effects known to be caused by calcipotriol include the following - Dry skin - Sensitivity of the skin to light resulting in a rash has also been reported - Eczema.
- Behandling med denne gel kan give øget kalciumkoncentration i dit blod og din urin (sædvanligvis hvis du har brugt for meget af gelen).
If you have an allergic reaction, stop taking Daivobet, tell your doctor immediately or go to the casualty department at your nearest hospital - Treatment with this gel may cause the level of calcium in your blood or urine to increase (usually when too much gel has been used).
CHMP var af den opfattelse, at der ikke var nogen klar information om, at lægemidlet ikke må bruges på de pågældende områder, og CHMP
The CHMP found that there was no clear statement that this product should not be used there and endorsed the following harmonised wording: “Skin of the face and genitals are very sensitive to corticosteroids.
- Infektioner (fordi dit immunsystem, som bekæmper infektioner, kan blive undertrykt eller svækket).
or an increase in pressure inside your eye (signs are eye pain, red eye, decreased or cloudy vision) - Infections (because your immune system, which fights infections, may be suppressed or weakened) - Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet).
50 microgram/g + 0.5 mg/g gel
Dovobet 50 microgram/g + 0.5 mg/g gel
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dacogen den 20. september 2012.
The European Commission granted a marketing authorisation valid throughout the European Union for Dacogen on 20 September 2012.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Dacogen.
This is a summary of the European public assessment report (EPAR) for Dacogen.
Over et fire ugers behandlingsforløb gives Dacogen dagligt de første fem dage.
In a 4-week treatment cycle, Dacogen is given daily for the first 5 days.
Der anbefales mindst fire behandlingsforløb, men de kan fortsættes, så længe som AML stadig holdes under kontrol.
At least 4 treatment cycles are recommended but they can be continued for as long as the AML remains under control.
Dosis afhænger af patientens højde og vægt.
The dose is calculated using the patient's height and weight.
Dacogen decitabin
Dacogen decitabine
Andre oplysninger om Dacogen
Other information about Dacogen
De patienter, der fik Dacogen, levede i gennemsnit 7,7 måneder, sammenholdt med 5,0 måneder for patienter, der fik støttende behandling eller behandling med cytarabin.
Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Dacogen?
What measures are being taken to ensure the safe and effective use of Dacogen?
Behandlingen fortsatte, så længe det var til fordel for patienterne.
Treatment was given for as long as patients benefited from it.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Dacogen.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dacogen.
Disse enzymer er ansvarlige for kræftens opståen og udvikling.
These enzymes promote the development and progression of cancer.
Behandling med Dacogen bør indledes under opsyn af en læge med erfaring i at anvende kemoterapi.
Treatment with Dacogen should be started under the supervision of a doctor who has experience in the use of chemotherapy.
Hvis du ønsker yderligere oplysninger om behandling med Dacogen, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Dacogen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Da antallet af patienter med AML er lavt, betragtes sygdommen som "sjælden", og Dacogen blev udpeget som "lægemiddel til sjældne sygdomme" den 8. juni 2006.
Because the number of patients with AML is low, the disease is considered ‘rare', and Dacogen was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2006.
Hvis patienten får svære bivirkninger, kan lægen beslutte at udsætte eller standse behandlingen med Dacogen.
If a patient develops certain severe side effects, the doctor may decide to delay or stop Dacogen treatment.
Det anvendes hos patienter, som ikke kan få en traditionel indledende kemoterapi (indledende behandling med kræftlægemidler).
It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines).
Den fuldstændige EPAR for Dacogen findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Dacogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Der var ingen større sikkerhedsmæssige betænkeligheder forbundet med Dacogen, og den overordnede sikkerhedsprofil svarede til sikkerhedsprofilen af lavdosis cytarabin bortset fra visse bivirkninger såsom infektioner og neutropeni, som var mere almindelige med Dacogen.
There were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine but some side effects such as infections and neutropenia were more common with Dacogen.
Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne overlevede.
The main measure of effectiveness was how long the patients lived.
Da det ikke vides, om det aktive stof udskilles i modermælk, skal patienter, der ammer, ophøre dermed, hvis de skal behandles med Dacogen.
As it is not known whether the active substance is excreted in breast milk, in the event that a patient is breastfeeding, they must discontinue breastfeeding if they require treatment with Dacogen.
CHMP fandt, at forbedringen i overlevelse med Dacogen hos patienter med AML var beskeden, men relevant, idet fordelene ved de nuværende behandlingsmuligheder er begrænsede hos patienter, som ikke kan få en traditionel indledende kemoterapi.
The CHMP noted that the improvement in survival with Dacogen in patients with AML was modest but relevant, as the benefits of current treatments are limited in patients who are not eligible for standard induction chemotherapy.
CHMP besluttede, at fordelene ved Dacogen opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Dacogen.
The CHMP decided that Dacogen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Dacogen blev sammenlignet med enten støttebehandling (enhver medicin eller teknik, der anvendes til at hjælpe patienterne, bortset fra kræftmedicin og operation) eller lavdosis cytarabin (et andet lægemiddel mod kræft).
Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding cancer medicines or surgery) or low-dose cytarabine (another cancer medicine).
Det aktive stof i Dacogen, decitabin, er en "cytidindeoxynukleosid-analog".
The active substance in Dacogen, decitabine, is a cytidine deoxynucleoside analogue.
I kroppen omdannes decitabin til decitabintrifosfat, som derefter indbygges i dna, hvor det blokerer enzymerne dna-metyltransferaser (DNMT).
In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA where it blocks the activity of enzymes called DNA methyltransferases (DNMTs).
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Dacogen findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Dacogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Hvilken risiko er der forbundet med Dacogen?
What is the risk associated with Dacogen?
Dacogen anvendes til at behandle patienter, der netop har fået stillet diagnosen akut melodi leukæmi (AML), en kræfttype, der påvirker de hvide blodlegemer.
Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Hvorfor blev Dacogen godkendt?
Why has Dacogen been approved?
Den fuldstændige liste over begrænsninger og bivirkninger ved Dacogen fremgår af indlægssedlen.
For the full list of all restrictions and side effects reported with Dacogen, see the package leaflet.
Dacogen blev undersøgt i en hovedundersøgelse, der omfattede 485 voksne, som netop havde fået stillet diagnosen AML, men som ikke kan få en traditionel indledende kemoterapi.
Dacogen has been studied in one main study involving 485 adults, who were newly diagnosed with AML but were not eligible for standard induction chemotherapy.
Det vil sige, at det ligner cytidindeoxynukleosid, der er en grundlæggende byggesten i cellernes genetiske materiale.
This means that it is similar to cytidine deoxynucleoside, a fundamental component of the DNA (genetic material) of cells.
Dacogen gives i en vene ved en infusion, der varer en time.
Dacogen is given as an infusion into a vein over one hour.
De hyppigste alvorlige bivirkninger (som optrådte hos flere end 20 % af patienterne) er lungebetændelse, trombocytopeni, neutropeni (for lavt antal neutrofiler, der er en type hvide blodlegemer), febril neutropeni (for lavt antal hvide blodlegemer med feber) og anæmi.
The most common serious side effects (seen in more than 20% of patients) include pneumonia (lung infection), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white blood cell count with fever) and anaemia.
Ved at blokere DNMT forhindrer decitabin kræftcellerne i at dele sig, og dermed dør de.
By blocking DNMTs, decitabine will prevent the increase of tumour cells and lead to their death.
Dacogen må ikke gives til ammende kvinder.
Dacogen must not be used in people who are breastfeeding.
De hyppigste bivirkninger ved Dacogen (som optrådte hos flere end 35 % af patienterne) er feber, anæmi (for lavt antal røde blodlegemer) og trombocytopeni (for lavt antal blodplader).
The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count).
Hvad er Dacogen?
What is Dacogen?
Lægemidlet udleveres kun efter recept.
Dacogen can only be obtained with a prescription.
Dacogen indeholder det aktive stof decitabin.
It contains the active substance decitabine.
Hvad anvendes Dacogen til?
What is Dacogen used for?
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 Dacogen.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dacogen have been included in the summary of product characteristics and the package leaflet.
Hvordan blev Dacogen undersøgt?
How has Dacogen been studied?
Dacogen er et pulver, der blandes til en infusionsvæske, opløsning, der gives som drop i en vene.
Dacogen is a powder that is made up into a solution for infusion (drip) into a vein.
Hvilken fordel viser undersøgelserne, at der er ved Dacogen?
What benefit has Dacogen shown during the studies?
Hvordan anvendes Dacogen?
How is Dacogen used?
Hvordan virker Dacogen?
How does Dacogen work?
Tidligere kendt som Zenas.
Previously known as Zenas.
Lægemidlets navn blev ændret til Firdapse den 28. januar 2010.
The name of the medicine was changed to Firdapse on 28 January 2010.
Firdapse er blevet godkendt under "særlige omstændigheder".
Firdapse has been authorised under ‘exceptional circumstances'.
Det fås som tabletter (10 mg).
It is available as tablets (10 mg).
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Firdapse.
This document is a summary of the European public assessment report (EPAR) for Firdapse.
Der er udarbejdet en risikostyringsplan for at sikre, at Firdapse anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Firdapse is used as safely as possible.
Den anbefalede startdosis af Firdapse er på 15 mg om dagen, som kan øges med 5 mg hver 4. eller 5. dag til maksimalt 60 mg om dagen.
The recommended starting dose of Firdapse is 15 mg per day, which can be increased by 5 mg every four to five days up to a maximum of 60 mg per day.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zenas til EUSA Pharma SAS den 23. december 2009.
The European Commission granted a marketing authorisation valid throughout the EU for Zenas on 23 December 2009.
Firdapse tages i doser fordelt på tre eller fire gange om dagen, og en enkelt dosis bør ikke overstige 20 mg. Firdapse skal tages sammen med mad.
Firdapse is taken in divided doses, three or four times a day, and a single dose should not be more than 20 mg. Firdapse should be taken with food.
Da antallet af patienter, der lider af LEMS, er lavt, betragtes sygdommen som "sjælden", og Firdapse blev udpeget som "lægemiddel til sjældne sygdomme" den 18. december 2002.
Because the number of patients with LEMS is low, the disease is considered ‘rare', and Firdapse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2002.