FrancophonIA/ELRC3.0 huggingface dataset:
English: Ocular use
Danish: Til okulær brug
English: - The other ingredients are benzalkonium chloride, trometamol; sodium chloride; hypromellose;
Danish: - Øvrige indholdsstoffer: Benzalkoniumchlorid, trometamol, natriumchlorid, hypromellose, renset vand.
English: EMADINE 0.5 mg/ml eye drops, solution emedastine
Danish: EMADINE 0,5 mg/ml øjendråber, opløsning emedastin
English: Single-dose container
Danish: Enkeltdosisbeholder
English: Scleral mononuclear cell infiltrates were present in 1/4 males and 1/4 females treated with 0.5 mg/ml and in 2/4 males and 1/4 females treated with1.0 mg/ml.
Danish: Scleral mononucleære celle-infiltrater blev fundet i 1/4 han- og 1/4 hunaber behandlet med 0,5 mg/ml og i 2/4 han- og 1/4 hunaber behandlet med 1,0 mg/ml Middel peak plasma-koncentration var omkring 1 ng/ml og 2 ng/ml ved behandling med henholdsvis 0,5 mg/ml og 1,0 mg/ml.
English: EMADINE 0.5 mg/ml, eye drops, solution
Danish: EMADINE 0,5 mg/ml, øjendråber, opløsning.
English: In vivo topical ocular administration of emedastine produces a concentration-dependent inhibition of histamine-stimulated conjunctival vascular permeability.
Danish: Ki er henholdsvis 1.3 nM, 49.064 nM og 12.430 nM. In vivo topikal okulær administration af emedastin giver en koncentrationsafhængig hæmning af den histaminstimulerede konjunktivalvaskulære permeabilitet.
English: Posology
Danish: Foliepose
English: Now turn over>
Danish: Vend>
English: The European Commission granted a marketing authorisation valid throughout the European Union for Procysbi on 06.09.2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Procysbi den 06.09.2013
English: This is a summary of the European public assessment report (EPAR) for Procysbi.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Procysbi.
English: Levels were 0.51 nmol/mg with Procysbi, compared with 0.44 nmol/mg with Cystagon.
Danish: Indholdet var 0,51 nmol/mg med Procysbi, sammenholdt med 0,44 nmol/mg med Cystagon.
English: Because the number of patients with cystinosis is low, the disease is considered ‘rare', and Procysbi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 September 2010.
Danish: Da antallet af patienter med cystinose er lavt, betragtes sygdommen som “sjælden”, og Procysbi blev udpeget som ”lægemiddel til sjældne sygdomme” den 20. september 2010.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Procysbi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Procysbi er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The recommended daily dose is calculated according to body surface area, as 1.30 g per m2 divided into 2 doses given every 12 hours.
Danish: Den anbefalede daglige dosis beregnes efter legemsoverflade med 1,30 g pr. m2, fordelt på to doser, der gives med 12 timers mellemrum.
English: Procysbi is available as gastroresistant capsules (25 and 75 mg).
Danish: Procysbi fås som enterokapsler (25 og 75 mg).
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Procysbi is available in a formulation that allows for a delayed release of the active substance in the body.
Danish: Det vil sige, at det svarer til et “referencelægemiddel”, der indeholder samme aktive stof, men Procysbi fås i en formulering, der forsinker frigivelsen af det aktive stof i kroppen.
English: A risk management plan has been developed to ensure that Procysbi is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Procysbi anvendes så risikofrit som muligt.
English: In a main study involving 43 patients with nephropathic cystinosis, there was no meaningful difference between the average levels of cystine in white blood cells during a 3-week treatment with the two medicines.
Danish: I en hovedundersøgelse med 43 patienter med nefropatisk cystinose var der ingen betydningsfuld forskel mellem de to lægemidler hvad angår det gennemsnitlige cystinindhold i de hvide blodlegemer ved 3 ugers behandling.
English: Procysbi is a ‘hybrid medicine'.
Danish: Procysbi er et “hybridt lægemiddel”.
English: The reference medicine for Procysbi is Cystagon.
Danish: Referencelægemidlet for Procysbi er Cystagon.
English: The full EPAR for Procysbi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Procysbi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Procysbi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Procysbi?
English: Gastroresistant means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Danish: “Enterokapsler” er kapsler, hvis indhold passerer gennem mavesækken uden at nedbrydes, før de når frem til tarmen.
English: The most common side effects with Procysbi (which may affect more than 1 in 10 people) are loss of appetite, vomiting, nausea (feeling sick), diarrhoea, lethargy (lack of energy) and pyrexia (fever).
Danish: De hyppigste bivirkninger med Procysbi (som kan forekomme hos mere end 1 ud af hver 10 behandlede) er nedsat appetit, opkastning, kvalme, diarré, letargi (sløvhed) og feber.
English: What is Procysbi and what is it used for?
Danish: Hvad er Procysbi, og hvad anvendes det til?
English: Cystinosis is an inherited disease in which excess amounts of cystine, an amino acid naturally found in the body, build up within cells, especially in the kidneys and the eyes, damaging them.
Danish: Cystinose er en arvelig sygdom, hvor cystin, en aminosyre, der normalt findes i kroppen, ophobes i unormale mængder i cellerne, navnlig i nyrerne og øjnene, som derved beskadiges.
English: Procysbi can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of cystinosis.
Danish: Procysbi fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af cystinose.
English: It is not intended to provide practical advice on how to use Procysbi.
Danish: Det er ikke en praktisk vejledning i, hvordan Procysbi bør anvendes.
English: Regarding its safety, the CHMP considered that the safety profile of mercaptamine is well established and the safety of Procysbi is expected to be similar to that of the reference medicine.
Danish: Vedrørende sikkerheden fandt CHMP, at sikkerhedsprofilen for mercaptamin er velkendt, og at sikkerheden ved Procysbi forventes at svare til referencelægemidlets.
English: Procysbi must not be used in people who are hypersensitive (allergic) to any form of mercaptamine or any of the other ingredients, or to penicillamine.
Danish: Procysbi må ikke anvendes hos personer, der er overfølsomme (allergiske) over for mercaptamin eller andre af indholdsstofferne eller over for penicillamin.
English: Procysbi given every 12 hours has been shown to be at least as effective as Cystagon given every 6 hours at maintaining the amount of cystine in white blood cells at acceptable levels (less than 1 nmol hemicystine per mg of white blood cell protein).
Danish: Procysbi, givet hver 12. time, er påvist at være mindst ligeså effektivt som Cystagon, givet hver sjette time, til at holde cystinindholdet i de hvide blodlegemer på et acceptabelt niveau (under 1 nmol hemicystin pr. mg protein i de hvide blodlegemer).
English: Why is Procysbi approved?
Danish: Hvorfor blev Procysbi godkendt?
English: The CHMP noted that Procysbi was shown to be at least as effective as Cystagon at maintaining the amount of cystine in white blood cells at acceptable levels.
Danish: CHMP bemærkede, at Procysbi var påvist at være mindst ligeså effektivt som Cystagon til at holde indholdet af cystin i de hvide blodlegemer på et acceptabelt niveau.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Procysbi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Procysbi findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: It must also not be used in women who are breastfeeding.
Danish: Procysbi må heller ikke anvendes hos kvinder, der ammer.
English: Procysbi is a medicine that contains the active substance mercaptamine (also known as cysteamine).
Danish: Procysbi er et lægemiddel, der indeholder det aktive stof mercaptamin (også kaldet cysteamin).
English: Other information about Procysbi
Danish: Andre oplysninger om Procysbi:
English: For more information about treatment with Procysbi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Procysbi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Procysbi, mercaptamine, reacts with cystine to form another amino acid, called cysteine, and a compound called a cysteine-cysteamine salt.
Danish: Det aktive stof i Procysbi, mercaptamin, reagerer med cystin og danner derved en anden aminosyre kaldet cystein, og et stof, der kaldes et cystein-cysteaminsalt.
English: The Committee also considered that the gastroresistant formulation, due to its less frequent administration, is expected to increase compliance with treatment and the quality of life of patients with cystinosis.
Danish: Udvalget tog desuden i betragtning, at enteroformuleringen som følge af de længere intervaller mellem doserne ventes at øge ordinationsefterlevelse og livskvalitet hos patienter med cystinose.
English: What are the risks associated with Procysbi?
Danish: Hvilke risici er der forbundet med Procysbi?
English: Procysbi mercaptamine
Danish: Procysbi mercaptamin
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Procysbi, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Procysbi er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: Cystine levels in white blood cells (which are measured as nmol hemicystine per mg white blood cell protein), or alternatively mercaptamine concentration in the blood, should be monitored and used to adjust the dose, which should never exceed 1.95 g per m2 per day.
Danish: Cystinindholdet i de hvide blodlegemer (måles i nmol hemicystin pr. mg protein de i hvide blodlegemer) eller alternativt koncentrationen af mercaptamin i blodet skal overvåges, og dosis tilpasses derefter.
English: For the full list of all side effects reported with Procysbi, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Procysbi fremgår af indlægssedlen.
English: For practical information about using Procysbi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Procysbi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The body is able to remove this salt from the cells.
Danish: Dette salt er kroppen i stand til at fjerne fra cellerne, så cystinindholdet i organerne nedsættes, og skaden på organerne mindskes.
English: How is Procysbi used?
Danish: Hvordan anvendes Procysbi?
English: How does Procysbi work?
Danish: Hvordan virker Procysbi?
English: What benefits of Procysbi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Procysbi?
English: In addition, the company that markets Procysbi will provide educational material to all doctors expected to prescribe the medicine, containing important safety information including the risk that the medicine may be harmful to the unborn child.
Danish: Desuden skal den virksomhed, der markedsfører Procysbi, udlevere oplysningsmateriale til de læger, som forventes at ordinere lægemidlet.
English: It is used in patients with nephropathic (kidney) cystinosis.
Danish: Procysbi anvendes til behandling af nefropatisk cystinose (cystinose, der angriber nyrerne).
English: Elderly (>65 years old)
Danish: Ældre (>65 år)
English: Get medical help immediately.
Danish: Søg omgående lægehjælp.
English: All comparisons against placebo were statistically significant.
Danish: Alle sammenligninger med placebo var statistisk signifikante.
English: The more active you are, the higher your calorie target.
Danish: Jo mere aktiv du er, jo højere kaloriemål.
English: It may be necessary to discontinue treatment.
Danish: Det kan være nødvendigt at afbryde behandlingen.
English: They generally occurred early in treatment (within 3 months) and most patients experienced only one episode.
Danish: Generelt optrådte de tidligt i behandlingen (inden for 3 måneder), og de fleste patienter oplevede kun en enkelt episode.
English: If you are unsure which level you are, choose Low activity.
Danish: Hvis du er usikker på hvilket niveau du tilhører, så vælg Lavt aktivitetsniveau.
English: Hepatitis that may be serious.
Danish: Hepatitis, som kan være alvorlig.
English: Therefore orlistat treatment should only be initiated after careful consideration of the possible impact in these patients.
Danish: Derfor skal behandling med orlistat kun initieres efter nøje overvejelse af den mulige indvirkning på disse patienter.
English: This pack includes:
Danish: Pakningen indeholder:
English: Choose your start date
Danish: Vælg din startdato
English: 4.5 Interaction with other medicinal products and other forms of interaction Ciclosporin
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Ciclosporin
English: See section 2, warnings and precautions.
Danish: Se punkt 2, advarsler og forsigtighedsregler.
English: They are sometimes called kilocalories or kcal. Energy may also be measured in kilojoules, which you may also see on food labels.
Danish: Nogen gange kaldes det kilokalorier eller kcal. Energi kan også måles i kilojoule, hvilket du kan se på fødevaredeklarationer.
English: FURTHER HELPFUL INFORMATION
Danish: FLERE NYTTIGE OPLYSNINGER
English: 24018, 1700 Λευκωσία
Danish: 24018, 1700 Λευκωσία Tηλ.
English: See the chart further on in this section.
Danish: Se tabellen senere i dette afsnit.
English: This could potentially lead to a decrease of immunosuppressive efficacy.
Danish: Dette kan potentielt medføre reduceret immunosuppressivitet.
English: Effects seen in blood tests
Danish: Virkninger, der kan ses i blodprøver
English: System organ class and frequency
Danish: Systemorganklasse og hyppighed
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppighed defineres som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), samt ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: There are limited data on the use of orlistat in the elderly.
Danish: Der er begrænsede data om anvendelse af orlistat til ældre.
English: Animal studies do not indicate harmful effects with respect to fertility.
Danish: Forsøg på dyr indicerer ingen skadelige virkninger med hensyn til fertilitet.
English: No data are available.
Danish: Der er ingen data tilgængelige.
English: Choose the level that most closely fits your daily routine.
Danish: Vælg det aktivitetsniveau der passer bedst på din daglige rutine.
English: The cumulative renal excretion of total orlistat-related materials was <2% of the given dose.
Danish: Den kumulative renale udskillelse af totalt orlistatrelateret materiale var < 2 % af den indgivne dosis.
English: Should a significant overdose of orlistat occur, it is recommended that the patient be observed for 24 hours.
Danish: I tilfælde af signifikant overdosering med orlistat anbefales det, at patienten observeres i 24 timer.
English: The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
Danish: Den daglige indtagelse af fedt, kulhydrat og protein bør fordeles mellem de tre hovedmåltider.
English: This does not mean that the tablets are not working.
Danish: Det betyder ikke, at tabletterne ikke virker.
English: When stored in the carry case: 1 month.
Danish: Ved opbevaring i etuiet: 1 måned.
English: Date of first authorisation: 23rd July 2007 Date of latest renewal: 29th June 2017
Danish: Dato for første markedsføringstilladelse: 23. juli 2007 Dato for seneste fornyelse: 29. juni 2017
English: Find your height on the chart.
Danish: Find din højde i skemaet.
English: This does not mean that the capsules are not working.
Danish: Det betyder ikke, at kapslerne ikke virker.
English: Calories are a measurement of the energy your body needs.
Danish: Kalorier er et mål for den energi din krop behøver.
English: Important information about some of the ingredients of alli How to take alli
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i alli Sådan skal du tage alli
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: alli is not recommended for people taking acarbose.
Danish: alli anbefales ikke til personer, som tager acarbose.
English: • Whenever the risk management system is modified, especially as the result of new information being received that lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: You can also visit your country specific alli website for further information about the alli weight loss programme.
Danish: Du kan også besøge din landsspecifikke alli-hjemmeside for yderligere information om alli vægttabsprogrammet.
English: Think about how much weight you want to lose and then set a target weight.
Danish: Tænk over, hvor meget du gerne vil tabe dig og fastsæt så et mål for dit vægttab.
English: Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Danish: Tag altid dette lægemiddel nøjagtigt som beskrevet i denne indlægsseddel eller efter de anvisninger, lægen eller apotekspersonalet har givet dig.
English: You may need to stop taking alli.
Danish: Måske skal du holde op med at tage alli.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: If this occurs, the patient should consult a doctor.
Danish: Hvis dette opstår skal patienten konsultere en læge.
English: However, any possible risk should be avoided (see section 6.6).
Danish: Dog bør en eventuel risiko undgås (se pkt.
English: Although weight loss was assessed during 12 months of treatment in both studies, most weight loss occurred within the first 6 months.
Danish: Selv om vægttab blev vurderet i løbet af de 12 måneders behandling i begge forsøg, opstod de væsentligste vægttab inden for de først 6 måneder.
English: This risk is increased in patients with underlying chronic kidney disease and/or volume depletion.
Danish: Denne risiko er øget hos patienter med underliggende kronisk nyresygdom og/eller volumendepletion.
English: Other medicines and alli alli may affect some medicines you have to take.
Danish: Brug af anden medicin sammen med alli alli kan måske påvirke nogle lægemidler, som du har brug for at tage.
English: sodium laurilsulfate, talc.
Danish: natriumlaurilsulfat, talcum.
English: Stop taking the tablets.
Danish: Stop med at tage tabletterne.
English: The time to reach complete excretion (faecal plus urinary) was 3 to 5 days.
Danish: Tiden til fuldstændig udskillelse (fækal plus renal) var 3-5 dage.
English: - acarbose, (an anti-diabetic medicine used to treat type 2 diabetes mellitus).
Danish: - acarbose (et lægemiddel, som anvendes til behandling af type 2-sukkersyge).
English: Approximately 97% of the administered dose was excreted in faeces and 83% of that as unchanged orlistat.
Danish: Ca. 97 % af den indgivne dosis blev udskilt i fæces, og heraf var 83 % uomdannet orlistat.
English: This medicine must not be taken by children and adolescents under 18 years old.
Danish: Dette lægemiddel må ikke anvendes af børn og teenagere under 18 år.
English: - Low activity means you do little or no walking, climbing stairs, gardening, or other physical activity on a daily basis.
Danish: - Lavt aktivitetsniveau betyder, at du dagligt udfører lidt eller ingenting af det følgende: gang, trappegang, havearbejde, eller andre fysiske aktiviteter.
English: Stop taking the capsules.
Danish: Stop med at tage kapslerne.
English: Povidone (E1201) (K-value 30)
Danish: Povidon (E1201) (K-værdi 30)
English: These may affect up to 1 in 10 people - Stomach (abdominal) pain.
Danish: Kan forekomme hos op til 1 ud af 10 personer - Mavepine (abdominalsmerter).
English: Treatment should not exceed 6 months.
Danish: Behandlingens varighed må ikke overskride 6 måneder.
English: The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing.
Danish: Effekten af orlistat medfører en øgning af fækalt fedt allerede 24 til 48 timer efter indgift.
English: This could be due to a decreased absorption of iodine salts and/or levothyroxine.
Danish: Dette kan skyldes et fald i absorptionen af jodsalte og/eller levothyroxin.
English: - a medicine for epilepsy as any changes in the frequency and severity of your convulsions should be discussed with your doctor.
Danish: - medicin mod epilepsi, da enhver ændring i hyppighed og alvor af dine kramper skal diskuteres med din læge.
English: - Do not take 2 tablets at the same time to make up for a forgotten tablet.
Danish: - Du må ikke tage 2 tabletter på samme tid for at “indhente” den tablet du glemte at tage.
English: - if you are under 18 years old.
Danish: - er under 18 år.
English: Orlistat is a potent, specific and long-acting inhibitor of gastrointestinal lipases.
Danish: Orlistat er en kraftig, specifik og langtidsvirkende hæmmer af gastrointestinale lipaser.
English: Such diet-related treatment effects may be a signal that you have eaten more fat than you should have done.
Danish: Sådanne kostbetingede gener kan være et signal om, at du har indtaget mere fedt, end du burde.
English: Orlistat minimally partitions into erythrocytes.
Danish: Orlistat fordeler sig minimalt i erytrocytter.
English: If you forget to take alli
Danish: Hvis du har glemt at tage alli
English: To help you reach your weight-loss goal you need to set two daily targets, one for calories and one for fat.
Danish: For at hjælpe dig til at nå dit mål for vægttabet skal du fastsætte to daglige mål: Et for kalorier og et for fedt.
English: C. OTHER CONDITIONS AND REQUIRMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN