FrancophonIA/ELRC3.0 huggingface dataset:
English: Following treatment with alitretinoin 0.5% gel, mean plasma concentrations in the female rats were generally below the lower limit of quantitation (5 nMol) and mean plasma concentrations in the male rats were about 200 nMol.
Danish: Efter behandling med alitretinoin 0,5% gel var de gennemsnitlige plasmakoncentrationer hos hunrotterne generelt under den nedre grænse for kvantificering (5 nmol), og de gennemsnitlige plasmakoncentrationer hos hanrotterne var ca. 200 nmol.
English: Panretin gel contains alcohol, keep away from naked flame.
Danish: Panretin gel indeholder alkohol og må ikke komme i nærheden af åben ild.
English: For any information about this medicine please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis De ønsker yderligere oplysninger om Panretin, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: You do not need to rub the gel into the lesion.
Danish: De behøver ikke at massere gelen ind i læsionen.
English: Plasma concentrations of 9-cis-retinoic acid were evaluated during clinical studies in patients with cutaneous lesions of AIDS-related KS after repeated multiple-daily dose application of Panretin gel for up to 60 weeks.
Danish: Plasmakoncentationerne af 9-cis-retinsyre blev vurderet i kliniske undersøgelser hos patienter med kutane læsioner af AIDS-relateret KS efter gentagne dosisapplikationer af Panretin gel flere gange dagligt i op til 60 uger.
English: Panretin gel is for cutaneous use and is unlikely to have an effect on the ability to drive and use machines.
Danish: Panretin gel er til kutan anvendelse, det er usandsynligt, at det skulle have nogen effekt på evnen til at føre motorkøretøj og betjene maskiner.
English: It is recommended that you should not eat more vitamin A in your diet than the amount suggested by your doctor.
Danish: Brug af Panretin sammen med mad og drikke Det anbefales, at De ikke spiser mere vitamin A i Deres kost end den mængde, Deres læge foreslår.
English: Local dermal toxicity associated with Panretin gel therapy generally resolved with treatment adjustment or discontinuation (see section 4.2).
Danish: Lokal hudtoksicitet i forbindelse med behandling med Panretin gel svandt i reglen med behandlingsjustering eller seponering (se pkt.
English: It is supplied in a multi-use 60 g epoxy-lined aluminium tube.
Danish: Den leveres i en 60 g epoxy-beklædt aluminiumstube til flergangsbrug.
English: Care should be taken not to bring the neonate into skin contact with areas to which Panretin has been recently applied.
Danish: Der skal udvises omhu for ikke at bringe den nyfødte i hudkontakt med områder, hvor der for nylig er påsmurt Panretin.
English: It is recommended that HIV-infected mothers do not breast-feed their children to exclude the risk of transmission of the virus.
Danish: For at undgå overførsel af virus anbefales det, at HIV-inficerede mødre ikke ammer deres børn.
English: Table 2 Adjustment guidelines for treatment-limiting toxicity LOCAL DERMAL IRRITATION
Danish: Tabel 2 Retningslinier for justering for behandlingsbegrænsende toksicitet LOKAL HUDIRRITATION (Gradueret iflg.
English: Care must be taken to avoid application of the gel to normal skin surrounding the lesions.
Danish: Der skal udvises omhu for at undgå at påsmøre gelen på normal hud rundt om læsionerne.
English: Uncommon (can occur in less than 1 in 100 but in more than 1 in 1000 patients treated): Infection
Danish: Ikke almindelige (som kan forekomme hos færre end 1 ud af 100, men flere end 1 ud af 1.000 patienter i behandling):
English: Driving and using machines Panretin is unlikely to affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Panretin vil påvirke Deres evne til at køre bil eller betjene maskiner.
English: Lesions
Danish: læsioner
English: This level is about 1/100 the mean concentration measured in male rats.
Danish: Denne koncentration er ca. 1/100 af gennemsnitskoncentrationen målt hos hanrotter.
English: How to use Panretin
Danish: Sådan skal De bruge Panretin
English: - Immediately after application, wipe the finger(s) you have used to apply the gel and any healthy skin touched by the gel with a disposable tissue.
Danish: - Umiddelbart efter påsmøringen aftørres den finger/de fingre, De har brugt til at påsmøre gelen, og al sund hud, der har været berørt med gelen, med køkkenrulle eller andet engangsmateriale.
English: However, the mutagenic potential has been evaluated, and alitretinoin has tested negative in the Ames test, the in vivo mouse micronucleus assay, the chromosomal aberration test in human lymphocytes, and the CHO cell mutation test.
Danish: Det mutagene potentiale er imidlertid blevet vurderet, og alitretinoin tester negativt ved Ames-testen, in vivo-musemikronukleus-assay'en, kromosomaberrationstesten i humane lymfocytter og CHO-cellemutationstesten.
English: You need to avoid applying the gel to the healthy skin around the lesion.
Danish: De skal undgå at smøre gel på den sunde hud rundt om læsionen.
English: Vehicle (N=72)
Danish: Vehikel (N=72)
English: The use of other topical products on treated KS lesions should be avoided.
Danish: Anvendelse af andre produkter til lokal behandling på behandlede KS-læsioner skal undgås.
English: The use of other topical products on Panretin treated KS lesions should be avoided.
Danish: Brugen af andre produkter til lokal behandling på Panretin-behandlede KS-læsioner bør undgås.
English: The range and frequency of detection of quantifiable plasma 9-cis-retinoic acid concentrations in patients with KS applying the medicinal product to up to 64 lesions were comparable to respective values in untreated patients.
Danish: Mængden og påvisningsfrekvensen af kvantificerbare plasmakoncentrationer af 9-cis-retinsyre hos patienter med KS, der påsmurte lægemidlet på op til 64 læsioner, var sammenlignelig med de respektive værdier hos ubehandlede patienter.
English: Women of child-bearing potential must use effective contraception during, and up to one month after cessation of treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i en måned efter behandlingsophør.
English: This dose in rabbits resulted in plasma concentrations more than 60 times the highest observed plasma concentration in patients with KS following topical application of Panretin gel.
Danish: Denne dosis resulterede hos kaniner i plasmakoncentrationer på mere end 60 gange den højest observerede plasmakoncentration hos patienter med KS efter lokal applikation af Panretin gel.
English: Sometimes it is necessary to interrupt treatment, your doctor will inform you about this.
Danish: Undertiden er det nødvendigt at afbryde behandlingen.
English: Mineral oil may be used between Panretin applications in order to help prevent excessive dryness or itching.
Danish: Mineralsk olie må anvendes mellem applikationer af Panretin for at medvirke til forebyggelse af udtalt tørhed eller kløe.
English: Panretin gel is supplied in a multi-use 60 g epoxy-lined aluminium tube.
Danish: Panretin gel leveres i en 60 g epoxy-beklædt aluminiumstube til flergangsbrug.
English: Alitretinoin was studied for genotoxic potential using the Ames test, the in vivo mouse micronucleus assay, the chromosomal aberration test in human lymphocytes, and the CHO cell mutation test.
Danish: Alitretinoin blev undersøgt for genotoksisk potentiale ved brug af Ames-testen, in vivo-musemikronukleus-assay'en, kromosomaberrationstesten i humane lymfocytter og CHO-cellemutationstesten.
English: - Mineral oil may be used between Panretin applications in order to help prevent excessive dryness or itching.
Danish: - Mineralsk olie må anvendes mellem påsmøringerne af Panretin for at medvirke til at forebygge udtalt tørhed eller kløe.
English: Protocol-specified dose regimen was application twice a day (BD) only, with downward adjustments for toxicity.
Danish: Protokolspecificeret dosisregimen var applikation kun 2 gange dagligt (2xdgl.)
English: No gross malformations were observed following oral administration to rabbits of doses 12 times the human topical dose (which resulted in plasma concentrations 60 times the highest observed plasma concentration in patients with KS following topical application of the gel).
Danish: Der sås ingen umiddelbart synlige misdannelser efter oral indgivelse til kaniner af doser på 12 gange den humane, lokale dosis (som resulterede i plasmakoncentrationer på 60 gange den højest observerede plasmakoncentration hos patienter med KS efter lokal applikation af gelen).
English: - CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG ANVENDELSE
English: lips, vagina, tip of the penis, rectum, or anus.
Danish: læber, skeden, spidsen af penis, endetarmen eller endetarmsåbningen.
English: Phlebitis, Vascular disorder
Danish: Flebitis, vaskulær sygdom
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Eisai Manufacturing Limited
English: 3 = Severe
Danish: 3 = Svær
English: - Do not apply the gel to healthy skin around a KS lesion.
Danish: - Påsmør ikke gelen på sund hud rundt om en KS-læsion.
English: Haemorrhage (bleeding at or around lesions), Oedema (oedema, swelling, inflammation), Peripheral oedema
Danish: Hæmoragi (blødning i eller rundt om læsionerne), ødem (ødem, hævelse, inflammation), perifert ødem
English: It is unlikely that the undesirable systemic side effects associated with oral retinoids will be observed with the use of Panretin gel because the range and frequency of quantifiable 9-cis-retinoic acid plasma levels concentrations after application of the medicinal product were comparable to the range and frequency of quantifiable plasma concentrations of circulating, naturally occurring 9-cis-retinoic acid in untreated individuals.
Danish: Det er usandsynligt, at de uønskede, systemiske bivirkninger i forbindelse med orale retinoider vil blive observeret ved brug af Panretin gel, da mængden og frekvensen af kvantificerbare plasmakoncentrationer af 9-cis-retinsyre efter applikation af lægemidlet var sammenlignelige med mængden og frekvensen af kvantificerbare plasmakoncentrationer af naturligt forekommende 9-cis-retinsyre i blodbanen hos ubehandlede personer.
English: Skin ulcer, Serous drainage, Exfoliative dermatitis (flaking, peeling, desquamation, exfoliation), Skin discoloration (brown discoloration, surrounding hyperpigmentation, paler), Dry skin
Danish: Hudsår, serøs drænage, exfoliativ dermatitis (afskalning i flager, afskalning, afstødning, exfoliation), misfarvning af huden (brun misfarvning, hyperpigmentering af omgivende væv, blegere), tør hud
English: Cellulitis, Vesiculobullous rash, Maculopapular rash, Allergic reaction
Danish: Cellulitis, vesikulobulløst udslæt, makulopapuløst udslæt, allergisk reaktion
English: Very common (can occur in more than 1 in 10 patients treated): Rash, scaling, irritation, redness Cracking, scabbing, crusting, draining, oozing Pain, burning, soreness
Danish: Meget almindelige (som kan forekomme hos mere end 1 ud af 10 patienter i behandling): Udslæt, afskalning, irritation, rødme
English: In rabbits, alitretinoin was shown to be teratogenic at a dose which resulted in plasma concentrations about 60 times the highest observed plasma concentration in male patients with KS following topical application of the gel.
Danish: Hos kaniner påvistes alitretinoin at være teratogent på en dosis, som resulterede i plasmakoncentrationer på cirka 60 gange den højest observerede plasmakoncentration hos mandlige patienter med KS efter lokal applikation af gelen.
English: Alitretinoin (9-cis-retinoic acid), a naturally-occurring endogenous hormone related to vitamin A, binds to and activates all known intracellular retinoid receptor subtypes (RAR, RAR, RAR, RXR, RXR, RXR).
Danish: Skønt alitretinoins molekylære virkning menes at være medieret gennem interaktion med retinoidreceptorerne, er den nøjagtige virkningsmekanisme af dette lægemiddel ukendt ved den lokale behandling af kutane læsioner af AIDS-relateret KS. Alitretinoin (9-cis-retinsyre), et naturligt forekommende, endogent hormon beslægtet med vitamin A, binder sig til og aktiverer alle kendte undertyper af intracellulære retinoidreceptor (RARα, RAR, RAR, RXRα, RXRβ, RXRγ).
English: Vehicle (N=134)
Danish: Vehikel (N=134)
English: Skin disorder (cracking, scab, crusting, excoriation, drainage, oozing), Rash (erythema, redness, scaling, irritation, dermatitis), Pruritus (itching, pruritus)
Danish: Hud og subkutane væv Hudlidelse (sprækning, sårskorpe, skorpedannelse, afskrabning, drænering, sivning), udslæt (erytem, rødme, afskalning, irritation, dermatitis), pruritus (kløe, pruritus)
English: The patient response rate was evaluated using the AIDS Clinical Trials Group (ACTG) criteria for lesion response in KS. Study 1 included an open-label phase, in which patients themselves elected to enroll.
Danish: Patienternes responsrate blev vurderet ved brug af AIDS Clinical Trials Group (ACTG)-kriterier for læsionsrespons ved KS.
English: C SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Danish: SÆRLIGE FORPLIGTELSER, SOM SKAL OPFYLDES AF INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: Patients with renal or hepatic impairment
Danish: Patienter med nyre- eller leverinsufficiens
English: What Panretin contains - The active substance is alitretinoin.
Danish: Panretin indeholder: - Aktivt stof: Panretin 0,1% gel er alitretinoin.
English: Two controlled, multicentre, randomised, double blind parallel group, Phase III studies provided the data for Panretin gel in the treatment of index cutaneous lesions of KS (Table 4).
Danish: Data for Panretin gel til behandling af indeks kutane KS-læsioner er fra to kontrollerede, randomiserede, dobbeltblinde, multicenter-fase III-undersøgelser med parallelgrupper (Tabel 4).
English: Paraesthesia (stinging, tingling)
Danish: Paræstesier (brænden, snurren)
English: Frequency of application
Danish: Applikationshyppighed
English: Vehicle N=72
Danish: N=72
English: Women of child-bearing potential must use a reliable form of contraception during treatment with Panretin gel (see section 4.6) and until one month after cessation of treatment.
Danish: Kvinder i den fødedygtige alder skal anvende en pålidelig form for kontraception under behandling med Panretin gel (se pkt.
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Common (can occur in less than 1 in 10 but in more than 1 in 100 patients treated): Flaking, peeling, dry skin
Danish: Almindelige (som kan forekomme hos færre end 1 ud af 10, men flere end 1 ud af 100 patienter i behandling):
English: Pharmacokinetic studies indicate that the range and frequency of detection of quantifiable 9-cis-retinoic acid plasma concentrations in patients with KS after application of the medicinal product were comparable to the range and frequency of detection of quantifiable plasma concentrations of circulating, naturally-occurring 9-cis-retinoic acid in untreated individuals (see section 5.2).
Danish: Farmakokinetiske undersøgelser viser, at mængden og påvisningsfrekvensen af kvantificerbare plasmakoncentrationer af 9-cis-retinsyre hos patienter med KS efter applikation af lægemidlet var sammenlignelige med mængden og påvisningsfrekvensen af kvantificerbare plasmakoncentrationer af naturligt forekommende 9-cis-retinsyre i blodbanen hos ubehandlede personer (se pkt.
English: In this latter group, the range and frequency of detection of quantifiable 9-cis-retinoic acid plasma concentrations in patients with KS after application of the medicinal product were comparable to the range and frequency of detection of quantifiable plasma concentrations of circulating, naturally-occurring 9-cis-retinoic acid in untreated individuals.
Danish: I den sidstnævnte gruppe var mængden og påvisningsfrekvensen af kvantificerbare plasmakoncentrationer af 9-cis-retinsyre hos patienter med KS efter applikation af lægemidlet sammenlignelige med mængden og påvisningsfrekvensen af kvantificerbare plasmakoncentrationer af naturligt forekommende 9-cis-retinsyre i blodbanen hos ubehandlede personer.
English: However, it is not currently certain to what extent topical treatment with Panretin gel would increase 9-cis-retinoic acid plasma concentrations, in women with KS above naturally occurring levels; therefore, Panretin is contraindicated ( see section 4.3) in pregnancy, or in women planning a pregnancy.
Danish: På nuværende tidspunkt er det imidlertid ikke sikkert, i hvilket omfang lokal behandling med Panretin gel ville forøge plasmakoncentrationerne af 9-cis-retinsyre hos kvinder med KS over naturligt forekommende koncentrationer.
English: Swelling, inflammation
Danish: Brænden, snurren Blødning
English: What Panretin is and what it is used for What you need to know before you use Panretin How to use Panretin
Danish: Det skal De vide, før De begynder at bruge Panretin Sådan skal De bruge Panretin Bivirkninger
English: Avoid the use of other products on your treated KS lesions such as insect repellents that you use on your skin.
Danish: Brug af anden medicin sammen med Panretin Undgå at anvende andre produkter, som anvendes på huden, på Deres behandlede KS-læsioner så som insektafvisende midler.
English: Protocol-specified dose regimen was application three times a day (TID) escalating to four times a day (QID) after two weeks, with downward adjustments for toxicity.
Danish: Protokolspecificeret dosisregimen var applikation 3 gange dagligt (3xdgl.)
English: B. CONDITIONS OF THE MARKETING AUTHORISATION
Danish: BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Duration of application
Danish: Applikationsvarighed
English: Posology
Danish: Kløe
English: Skin discoloration
Danish: Misfarvning af huden Sår i huden
English: How to store Panretin
Danish: Panretin Vehikel
English: Vehicle N=134
Danish: N= 134 N=134 N=62
English: Isemid (torasemide)
Danish: Isemid (torasemid)
English: Isemid received a marketing authorisation valid throughout the EU on 09/01/2019.
Danish: Isemid modtog en markedsføringstilladelse med gyldighed i hele EU den 09/01/2019.
English: This overview was last updated in November 2018.
Danish: Denne oversigt blev sidst ajourført i 11-2018.
English: Further information on Isemid can be found on the Agency's website: ema.europa.eu/ medicines/veterinary/EPAR/isemid.
Danish: Yderligere oplysninger om Isemid findes på agenturets websted under: ema.europa.eu/ medicines/veterinary/EPAR/isemid.
English: Other information about Isemid
Danish: Andre oplysninger om Isemid
English: Isemid contains the active substance torasemide.
Danish: Isemid indeholder det aktive stof torasemid.
English: It works by increasing the loss of water and salt in the urine.
Danish: Det virker ved at øge udskillelsen af vand og salt i urinen.
English: This medicine may also cause hypersensitivity (allergic) reactions.
Danish: Dette lægemiddel kan også forårsage overfølsomhedsreaktioner (allergiske reaktioner).
English: The dose is then reduced and adjusted according the dog's response.
Danish: Derefter reduceres dosis, og den tilpasses efter hundens respons.
English: The European Medicines Agency decided that Isemid's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Isemid opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: What is Isemid and what is it used for?
Danish: Hvad er Isemid, og hvad anvendes det til?
English: Isemid must not be given at the same time as other diuretics which work in the same way as torasemide.
Danish: Isemid må ikke gives samtidig med andre vanddrivende midler, der virker på samme måde som torasemid.
English: An overview of Isemid and why it is authorised in the EU
Danish: En oversigt over Isemid, og hvorfor det er godkendt i EU
English: The usual dose is 0.13 to 0.25 mg torasemide per kg bodyweight once daily.
Danish: Den sædvanlige dosis er 0,13 til 0,25 mg torasemid pr. kg kropsvægt en gang dagligt.
English: It is given once daily and the starting dose depends on bodyweight.
Danish: Det gives en gang dagligt, og dosis afhænger af kropsvægten.
English: Torasemide is a diuretic medicine.
Danish: Torasemid er et vanddrivende lægemiddel.
English: The tablet can be given with food or directly into the mouth if the dog does not take it easily.
Danish: Tabletten kan gives sammen med mad eller direkte i munden, hvis hunden ikke tager den spontant.
English: Why is Isemid authorised in the EU?
Danish: Hvorfor blev Isemid godkendt i EU?
English: This may be increased for up to 5 days to a maximum of 0.4 mg per kg bodyweight once daily in dogs with moderate to severe fluid retention in the lungs.
Danish: Dette kan øges i op til fem dage til højst 0,4 mg pr. kg kropsvægt en gang dagligt hos hunde med moderat til svær væskeophobning i lungerne.
English: Congestive heart failure is a condition when the heart cannot pump enough blood around the body.
Danish: Kongestivt hjertesvigt er en sygdom, hvor hjertet ikke er i stand til at pumpe tilstrækkeligt med blod rundt i kroppen.
English: People who are hypersensitive to torasemide, sulfonamides or to any of the other ingredients in Isemid should avoid contact with the medicine.
Danish: Personer, som er overfølsomme over for torasemid, sulfonamider eller andre af indholdsstofferne i Isemid, bør undgå kontakt med lægemidlet.
English: What are the risks associated with Isemid?
Danish: Hvilke risici er der forbundet med Isemid?
English: The most common side effects with Isemid (which may affect more than 1 in 10 animals) are poor function of the kidneys, alterations in blood tests measuring kidney function, haemoconcentration (increase in the concentration of red blood cells circulating in the blood), and changes in electrolyte (salt) levels (chloride, sodium, potassium, phosphorus, magnesium and calcium).
Danish: De hyppigste bivirkninger ved Isemid (som kan optræde hos mere end 1 ud af 10 dyr) er ringe nyrefunktion, ændringer i blodprøver for nyrefunktion, hæmokoncentration (forhøjet koncentration af røde blodlegemer i blodet) og ændringer i elektrolytniveauerne (saltniveauerne) (klorid, natrium, kalium, fosfor, magnesium og calcium).
English: Isemid is available as tablets and can only be obtained with a prescription.
Danish: Isemid fås som tabletter og udleveres kun efter recept.
English: Isemid (torasemide) EMA/790616/2018
Danish: Isemid (torasemid) EMA/15610/2019
English: If the product is accidentally swallowed by a person, particularly by a child, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Hvis produktet ved hændeligt uheld sluges af en person, i særdeleshed børn, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: This decreases the overall blood volume, reducing the effort needed for the heart to pump blood and thereby improving its function.
Danish: Dette nedsætter den samlede blodvolumen og dermed hjertets pumpearbejde, så hjertefunktionen bliver bedre.
English: In a field study involving 321 dogs with congestive heart failure, treatment with Isemid was compared with another established diuretic medicine, furosemide.
Danish: I et feltstudie, som omfattede 321 hunde med kongestivt hjertesvigt, blev behandling med Isemid sammenlignet med et andet almindeligt anerkendt vanddrivende lægemiddel kaldet furosemid.
English: Any part-used tablets should be returned to the blister pack and then to the original carton to keep them out of the reach of children.
Danish: Tabletdele skal lægges tilbage i blisterpakningen og ind i den originale yderpakning, så de ikke er tilgængelige for børn.