FrancophonIA/ELRC3.0 huggingface dataset:
English: Peyona 20 mg/ml solution for infusion and oral solution Caffeine citrate (equivalent to 10 mg/ml of caffeine base) IV/oral use
Danish: Peyona 20 mg/ml infusionsvæske, opløsning og oral opløsning Caffeincitrat (svarende til 10 mg/ml caffein (base)) i.v./oral anvendelse
English: In newborn infants born to mothers who consumed large quantities of caffeine prior to delivery, baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate (see section 4.4).
Danish: Hos nyfødte børn, hvis mødre indtog store mængder caffein inden fødslen, bør baseline caffeinkoncentrationerne i plasma måles inden påbegyndelse af behandling med caffeincitrat (se pkt.
English: • If your newborn has frequent regurgitation
Danish: • Hvis Deres nyfødte barn ofte gylper
English: In a post authorisation safety study, the frequency of adverse reactions in a small number of very premature infants with renal/hepatic imparment appeared to be higher as compared to premature infants without organ impairment (see sections 4.4 and 4.8).
Danish: I et sikkerhedsstudie, udført efter udstedelse af markedsføringstilladelsen, syntes hyppigheden af bivirkninger at være højere hos et lille antal meget præmature spædbørn med nedsat nyre-/leverfunktion sammenlignet med præmature spædbørn uden nedsat organfunktion (se pkt.
English: In newborn infants born to mothers who consumed large quantities of caffeine prior to delivery, baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate, since caffeine readily crosses the placenta into the foetal circulation (see sections 4.2 and 5.2).
Danish: Hos nyfødte børn, hvis mødre indtog store mængder caffein inden fødslen, bør baselinecaffeinkoncentrationerne i plasma måles inden påbegyndelse af behandling med caffeincitrat, da caffein let krydser placentaen og går over i fostrets kredsløb (se pkt.
English: Route
Danish: Administrationsvej
English: The known pharmacology and toxicology of caffeine and other methylxanthines predict the likely adverse reactions to caffeine citrate.
Danish: Caffeincitrats sandsynlige bivirkninger kan forudsiges på baggrund af den kendte farmakologi og toksikologi for caffein og andre metylxantiner.
English: − infants with hepatic and renal impairment (see sections 4.4 and 5.2)
Danish: − spædbørn med nedsat lever- og nyrefunktion (se pkt.
English: Peyona 20 mg/ml solution for infusion and oral solution Caffeine citrate (equivalent to 10 mg/ml of caffeine base)
Danish: Peyona 20 mg/ml infusionsvæske, opløsning og oral opløsning Caffeincitrat (svarende til 10 mg/ml caffein (base))
English: Hyperglycaemia
Danish: Metabolisme og ernæring Hyperglykæmi
English: Breast-feeding mothers of newborn infants treated with caffeine citrate should not ingest caffeinecontaining foods and beverages or medicinal products containing caffeine (see section 4.6), since caffeine is excreted into breast milk (see section 5.2).
Danish: Ammende mødre til nyfødte børn, der behandles med caffeincitrat, bør ikke indtage caffeinholdige mad- og drikkevarer eller lægemidler, der indeholder caffein (se pkt.
English: Adverse Reaction
Danish: Overfølsomhedsreaktion
English: Arrhythmia
Danish: Krampeanfald
English: • If your newborn has a reduced weight gain or food intake • If you (the mother) consumed caffeine prior to delivery
Danish: • Hvis De (moderen) indtog caffein inden fødslen
English: - If you have further questions, please ask your baby's doctor.
Danish: - Spørg Deres spædbarns læge, hvis der er mere, De vil vide.
English: • If your newborn suffers from seizures
Danish: • Hvis Deres nyfødte barn lider af krampeanfald
English: A large multicentre study (n=2006) investigating long-term outcome of premature infants treated with caffeine citrate (see section 5.1) did not show an increased frequency of necrotising enterocolitis in the caffeine group when compared to placebo.
Danish: Et stort, multicenterstudie (n=2006), der undersøgte det langsigtede resultat af behandling af præmature nyfødte børn med caffeincitrat (se pkt.
English: Nervous system disorders Convulsion
Danish: Infusionsvæske, opløsning.
English: How to store Peyona
Danish: Sådan vil Deres spædbarn få Peyona
English: What Peyona is and what it is used for What you need to know before your baby is given Peyona How to use Peyona
Danish: Det skal De vide, før Deres spædbarn begynder at få Peyona Sådan vil Deres spædbarn få Peyona Bivirkninger
English: Immune system disorders Hypersensitivity reaction
Danish: Ikke kendt sygdomme Immunsystemet
English: If your newborn receives more Peyona than he/she should
Danish: Hvis Deres nyfødte spædbarn har fået for meget Peyona
English: Caffeine has been shown to increase heart rate, left ventricular output, and stroke volume in published studies.
Danish: Publicerede undersøgelser har vist, at caffein øger hjerterytmen, venstre ventrikelfunktion og slagvolumen.
English: Each 3 ml ampoule contains 60 mg caffeine citrate (equivalent to 30 mg of caffeine base).
Danish: Hver 3 ml ampul indeholder 60 mg caffeincitrat (svarende til 30 mg caffein).
English: Each ml contains 20 mg caffeine citrate (equivalent to 10 mg caffeine).
Danish: Hver ml indeholder 20 mg caffeincitrat (svarende til 10 mg caffein).
English: Each ml contains 20 mg caffeine citrate (equivalent to 10 mg/ml of caffeine base).
Danish: Hver ml indeholder 20 mg caffeincitrat (svarende til 10 mg/ml caffein (base)).
English: Each 1 ml ampoule contains 20 mg caffeine citrate (equivalent to 10 mg of caffeine base).
Danish: Hver 1 ml ampul indeholder 20 mg caffeincitrat (svarende til 10 mg caffein (base)).
English: Seizures
Danish: Døvhed
English: Chiesi Pharmaceuticals B.V. Tel: +31 88 501 64 00
Danish: Tel: +31 88 501 64 00
English: Theophylline
Danish: Teofyllin
English: Each ml of solution contains 20 mg of caffeine citrate (equivalent to 10 mg of caffeine base).
Danish: Hver ml opløsning indeholder 20 mg caffeincitrat (svarende til 10 mg caffein (base)).
English: Hepatic and renal impairment
Danish: Nedsat lever- eller nyrefunktion
English: Continued treatment is needed to maintain the beneficial effects and may lead to further improvement.
Danish: Der kræves fortløbende behandling for at fastholde den gavnlige virkning, og dette kan medføre yderligere forbedring.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Vaniqa on 20 March 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vaniqa den 20. marts 2001.
English: When this enzyme is blocked, the growth of hair is slowed down.
Danish: Når dette enzym blokeres, vokser håret langsommere.
English: This is a summary of the European public assessment report (EPAR) for Vaniqa.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vaniqa.
English: The full EPAR for Vaniqa can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Vaniqa findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Vaniqa eflornithine
Danish: Vaniqa eflornithin
English: In both studies, significant improvement was seen with Vaniqa compared with placebo.
Danish: I begge undersøgelser kunne der iagttages væsentlige forbedringer med Vaniqa sammenlignet med placebo.
English: Women using Vaniqa may still need to use other means to remove hair (plucking, shaving).
Danish: Kvinder, som anvender Vaniqa, kan stadig have behov for at benytte andre midler til fjernelse af hår (plukning, barbering).
English: 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 Vaniqa.
Danish: 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 Vaniqa.
English: The effectiveness of the treatment was assessed at the end of the study by a doctor who graded the hirsutism as ‘clear/almost clear', ‘marked improvement', ‘improved' or ‘no improvement/worse', 48 hours after women had shaved the treated areas of the face and under the chin.
Danish: Behandlingens virkning blev vurderet ved undersøgelsens afslutning af en læge, der klassificerede hirsutismen som ”borte/næsten borte”, ”markant forbedret”, ”forbedret” eller ”ikke forbedret/forværret” 48 timer efter, at kvinderne havde barberet de behandlede områder af ansigtet og under hagen.
English: The active substance in Vaniqa, eflornithine, works by blocking the action of an enzyme called ornithine decarboxylase.
Danish: Det aktive stof i Vaniqa, eflornithin, virker ved at blokere virkningen af et enzym kaldet ornithin decarboxylase.
English: Vaniqa is a white cream that contains the active substance eflornithine (115 mg).
Danish: Vaniqa er en hvid creme, som indeholder det aktive stof eflornithin (115 mg).
English: Facial hirsutism is excessive growth on the face of coarse hair, often in a male pattern.
Danish: Hirsutisme er overdreven vækst i ansigtet af groft hår, ofte i et maskulint mønster.
English: The CHMP decided that Vaniqa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Vaniqa er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Vaniqa.
English: Vaniqa should not be used in people who may be hypersensitive (allergic) to eflornithine or any of the other ingredients.
Danish: Vaniqa må ikke anvendes af personer, som kan være overfølsomme (allergiske) over for eflornithin eller et af de øvrige indholdsstoffer.
English: For more information about treatment with Vaniqa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vaniqa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Vaniqa has been studied in two clinical trials involving 596 women treated for up to 24 weeks with Vaniqa or placebo (a dummy treatment, in this case the cream without any active substance).
Danish: Vaniqa blev undersøgt i to kliniske undersøgelser af 596 kvinder, der blev behandlet i op til 24 uger med Vaniqa eller placebo (en virkningsløs behandling, i dette tilfælde den samme creme uden det aktive stof).
English: Vaniqa is used for the treatment of facial hirsutism in women.
Danish: Vaniqa anvendes til behandling af hirsutisme i ansigtet hos kvinder.
English: This enzyme is found in the bulb of the hair follicle where it controls hair production.
Danish: Dette enzym findes i hårsækkens bulbus, hvor det kontrollerer hårproduktionen.
English: The most common side effect with Vaniqa (seen in more than 1 patient in 10) is acne.
Danish: Den hyppigste bivirkning ved Vaniqa (som optræder hos flere end 1 ud af 10 patienter) er acne.
English: Vaniqa should be stopped if no improvements are noticed within four months of starting treatment.
Danish: Behandlingen med Vaniqa skal ophøre, hvis der ikke kan iagttages forbedringer fire måneder efter behandlingens start.
English: When the results were combined, a successful outcome (graded as ‘clear/almost clear' or ‘marked improvement') was seen in 35% of the women treated with Vaniqa, compared with 9% of those treated with placebo.
Danish: Når resultaterne blev kombineret, kunne der ses et vellykket resultat (klassificeret som ”borte/næsten borte” eller ”markant forbedret”) hos 35 % af de kvinder, som blev behandlet med Vaniqa, sammenlignet med 9 % af dem, der blev behandlet med placebo.
English: Other information about Vaniqa
Danish: Andre oplysninger om Vaniqa:
English: Vaniqa is applied to clean and dry affected areas of the face and under the chin twice a day (at least eight hours apart).
Danish: De berørte områder i ansigtet og under hagen renses og tørres, inden Vaniqa påføres to gange dagligt (med mindst otte timers interval).
English: It is applied in a thin layer and rubbed in thoroughly.
Danish: Cremen påføres i et tyndt lag og gnides derefter grundigt ind i huden.
English: Improvements may be noticed within eight weeks of starting treatment.
Danish: Der kan iagttages forbedringer otte uger efter behandlingsstart.
English: What is the risk associated with Vaniqa?
Danish: Hvilken risiko er der forbundet med Vaniqa?
English: Improvement was seen as early as eight weeks after starting treatment.
Danish: Der kunne iagttages en forbedring så tidligt som otte uger efter behandlingens start.
English: For the full list of all the side effects reported with Vaniqa, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Vaniqa fremgår af indlægssedlen.
English: What is Vaniqa?
Danish: Hvad er Vaniqa?
English: How has Vaniqa been studied?
Danish: Hvordan blev Vaniqa undersøgt?
English: What is Vaniqa used for?
Danish: Hvad anvendes Vaniqa til?
English: How is Vaniqa used?
Danish: Hvordan anvendes Vaniqa?
English: What benefit has Vaniqa shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Vaniqa?
English: How does Vaniqa work?
Danish: Hvordan virker Vaniqa?
English: Strength Pharmaceutical form Route of administration
Danish: Lægemiddelform Administration Emballage
English: (Invented) name
Danish: MF (EU)-nummer (Særnavn) Navn Styrke
English: This summary was last updated in July 2013.
Danish: Dette sammendrag blev sidst ajourført i juli 2013.
English: Treatment may then be continued at the same dose given once a day.
Danish: Derefter kan der fortsættes med samme dosis en gang dagligt.
English: Hands should be washed after handling the tablets.
Danish: Der skal vaskes hænder efter håndtering af tabletterne.
English: Oclaticinib
Danish: Apoquel oclacitinib
English: Other information about Apoquel:
Danish: Andre oplysninger om Apoquel:
English: One study involved 220 dogs and the second involved 299 dogs.
Danish: Den ene undersøgelse omfattede 220 hunde, den anden 299 hunde.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Apoquel on 12/09/2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Apoquel den 12. september 2013.
English: Treatment should be started at a dose of 0.4 - 0.6 mg per kilogram bodyweight twice a day for up to two weeks.
Danish: Behandlingen skal indledes med en dosis på 0,4-0,6 mg/kg kropsvægt to gange dagligt i op til to uger.
English: The success rates in the second study were similar.
Danish: Den anden undersøgelse gav tilsvarende succesrater.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Apoquel exceed the risks for the approved indications and recommended that Apoquel be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Apoquel overstiger risiciene til de godkendte anvendelser, og anbefalede udstedelse af markedsføringstilladelse for Apoquel.
English: Apoquel is a veterinary medicine that contains the active substance oclaticinib.
Danish: Apoquel er et veterinærlægemiddel, der indeholder det aktive stof oclacitinib.
English: Apoquel tablets are available in three different strengths (3.5 mg, 5.4 mg and 16 mg) to cover a range of dog weights.
Danish: Apoquel tabletter fås i tre forskellige styrker (3,5 mg, 5,4 mg og 16 mg) til hunde af forskellig vægt.
English: In both, Apoquel was compared with placebo.
Danish: I begge undersøgelser blev Apoquel sammenlignet med placebo.
English: In case of accidental ingestion, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Danish: Ved utilsigtet indtagelse skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: The active substance in Apoquel, oclacitinib, is an immunomodulator (a medicine that changes the activity of the immune system) that works by blocking the action of enzymes known as Janus kinases.
Danish: Det aktive stof i Apoquel, oclacitinib, er et immunmodulerende middel (et lægemiddel, der ændrer immunsystemets aktivitet), som virker ved at blokere virkningen af enzymer af typen Janus-kinaser.
English: The most common side effects were diarrhoea, vomiting and loss of appetite in decreasing order of frequency.
Danish: De hyppigste bivirkninger var diarré, opkastninger og nedsat appetit, angivet efter faldende hyppighed.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Danish: Benefit/risk-forholdet (afvejningen af fordele og risici) fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: What is the risk associated with Apoquel?
Danish: Hvilken risiko er der forbundet med Apoquel?
English: In one, Apoquel was compared with prednisolone (an immunosuppressant) in 220 dogs, and in the other Apoquel was compared with placebo (dummy treatment) in 436 dogs.
Danish: I den ene blev Apoquel sammenlignet med prednisolon (et immunundertrykkende middel) hos 220 hunde, og i den anden blev Apoquel sammenlignet med placebo (virkningsløs behandling) hos 436 hunde.
English: The measure of effectiveness in the studies was based on the assessment by the dog owner of the severity of the pruritus and improvements in the dog's behaviour using a standard scale.
Danish: I undersøgelserne blev virkningen vurderet på grundlag af hundeejerens bedømmelse af kløens sværhedsgrad og forbedringer i hudens adfærd, angivet på en standardskala.
English: These enzymes play an important role in the processes of inflammation and itchiness including those involved in allergic dermatitis and atopic dermatitis in dogs.
Danish: Disse enzymer spiller en vigtig rolle i inflammationsprocessen og kløe, og nogle af dem er involveret i allergisk dermatitis og atopisk dermatitis hos hunde.
English: Why has Apoquel been approved?
Danish: Hvorfor blev Apoquel godkendt?
English: In the pruritus study comparing Apoquel with prednisolone, both medicines were shown to be effective, with a successful response seen in 68% of dogs treated with Apoquel, and 76% of those treated with prednisolone.
Danish: I undersøgelsen af kløe, hvor Apoquel blev sammenlignet med prednisolon, var begge lægemidler effektive og gav tilfredsstillende respons hos 68 % af de hunde, der blev behandlet med Apoquel, og 76 % af dem, der blev behandlet med prednisolon.
English: What is Apoquel?
Danish: Hvad er Apoquel?
English: Studies in atopic dermatitis also used assessment of skin lesions on a score known as the canine atopic dermatitis extent and severity index (CADESI).
Danish: I undersøgelser af atopisk dermatitis vurderes hudforandringerne desuden på skalaen “atopic dermatitis extent and severity index” (CADESI).
English: Apoquel is used in dogs to treat pruritus (itching) associated with allergic dermatitis (inflammation of the skin).
Danish: Apoquel anvendes til behandling af kløe (pruritus) hos hunde ved allergisk dermatitis (inflammation af huden).
English: For a full list of all side-effects reported with Apoquel, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Apoquel fremgår af indlægssedlen.
English: For atopic dermatitis the treatment success rate for Apoquel-treated dogs in the first study was 66% compared with 4% in placebo-treated dogs using pruritus assessment; the results for CADESI scores were 49% and 4% respectively.
Danish: For atopisk dermatitis var succesraten med Apoquel i den første undersøgelse 66 %, mod 4 % med placebo, vurderet efter graden af kløe; resultaterne i CADESI-score var hhv. 49 % og 4 %.
English: Apoquel should not be given to dogs less than one year of age or weighing less than 3 kg. Apoquel should not be given to dogs with signs of immune suppression or progressive cancer as Apoquel has not been studied in such cases.
Danish: Apoquel bør ikke gives til hunde med tegn på immunundertrykkelse eller fremadskridende kræft, da Apoquel ikke er undersøgt i sådanne tilfælde.
English: By blocking the enzymes, Apoquel reduces the inflammation and itchiness associated with the disease.
Danish: Da oclacitinib blokerer disse enzymer, forventes det at mindske inflammation og kløe ved sygdommen.
English: It is also used in dogs to treat atopic dermatitis.
Danish: Det anvendes desuden til behandling af atopisk dermatitis hos hunde.
English: The atopic dermatitis indication was also investigated in two field studies.
Danish: Anvendelsen til atopisk dermatitis blev desuden undersøgt i to feltundersøgelser.
English: The action of Apoquel in pruritus associated with allergic dermatitis was studied in two field studies.
Danish: Virkningen af Apoquel ved kløe i forbindelse med allergisk dermatitis blev undersøgt i to feltundersøgelser.
English: When compared with placebo, the success rate was 67% for Apoquel-treated dogs and 29% for placebo-treated dogs.
Danish: Ved sammenligning med placebo var succesraten 67 % med Apoquel, og 29 % med placebo.
English: How has Apoquel been studied?
Danish: Hvordan blev Apoquel undersøgt?
English: What is Apoquel used for?
Danish: Hvad anvendes Apoquel til?
English: For the appropriate strength of tablets and number of tablets to be given, see the dosage table in the package leaflet.
Danish: Af dosistabellen i indlægssedlen fremgår det, hvilken tabletstyrke og hvor mange tabletter der skal anvendes.
English: What benefit has Apoquel shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Apoquel?
English: How does Apoquel work?
Danish: Hvordan virker Apoquel ?
English: A single injection is enough.
Danish: En enkelt injektion er nok.
English: Harmful for those suffering from alcoholism.
Danish: Skadeligt for mennesker, der lider af alkoholisme.
English: Date of first authorisation: 27 July 2000 Date of latest renewal: 28 July 2010
Danish: Dato for første tilladelse: 27. juli 2000 Dato for seneste fornyelse: 28. juli 2010
English: • if you are pregnant
Danish: • hvis De er gravid.
English: It collects in a small area of your brain.
Danish: Det samler sig i et lille område af Deres hjerne.
English: It will be passed out of the body in a few days without need for you to take special precautions.
Danish: Den vil blive udskilt af kroppen i løbet af nogle få dage, uden at De behøver at tage særlige forholdsregler.
English: I) which remains in your body will naturally lose its radioactivity.
Danish: I), som forbliver i Deres krop, vil naturligt miste dets radioaktivitet.
English: There is no experience in types of tremor other than essential tremor.
Danish: Der er ikke erfaring fra andre typer af tremor end essentiel tremor.
English: See also section 6.6.
Danish: Se også sektion 6.6.
English: Not known: frequency cannot be estimated from the available data.
Danish: Ikke kendt: hyppigheden kan ikke estimeres ud fra forhåndenværende data.
English: • You will need to continue to do this for 3 days, until the radioactivity is no longer in your body.
Danish: • De skal fortsætte med at gøre dette i 3 dage, indtil der ikke længere er radioaktivitet tilbage i kroppen.
English: • Periodic Safety Update Reports
Danish: • Periodiske sikkerhedsopdateringsrapporter
English: • A picture, known as a scan, can be taken.
Danish: • Der kan tages et billede, der kaldes en scanning.
English: They should tell you anything you need to do for the safe use of this medicine.
Danish: De vil fortælle Dem alt, hvad De skal gøre for sikker brug af denne medicin.
English: This can give the doctor valuable information about how that organ is working.
Danish: Dette kan give lægen værdifuld information om, hvorledes organet fungerer.
English: A minimum of 500k counts should be collected for optimal images.
Danish: Et minimum på 500k counts bør optages for at opnå optimale billeder.
English: DaTSCAN will always be used in a hospital or a similar place.
Danish: DaTSCAN vil altid blive anvendt på et hospital eller et lignende sted.