FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 ml (100 µg/ml).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldt injektionssprøjte indeholder 50 mikrogram darbepoetin alfa i 0,5 ml (100 µg/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml vial 15 micrograms darbepoetin alfa.
Danish: Hvert 1 ml hætteglas indeholder 15 mikrogram darbepoetin alfa.
English: NAME OF THE MEDICINAL PRODUCT Nespo 500 micrograms solution for injection in a pre-filled pen Darbepoetin alfa
Danish: LÆGEMIDLETS NAVN Nespo 500 µg injektionsvæske Darbepoetin alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml vial 40 micrograms darbepoetin alfa.
Danish: Hvert 1 ml hætteglas indeholder 40 mikrogram darbepoetin alfa.
English: Remember
Danish: Desuden må
English: Annex I List of medicinal products affected by the procedure
Danish: Bilag I Liste over lægemidler, som er omfattet af proceduren
English: You may need to read it again
Danish: Du kan få brug for at læse den igen.
English: Results from literature suggest the following:
Danish: Resultater fra litteraturen tyder på følgende:
English: Date of latest renewal: 18 December 2018.
Danish: Dato for seneste fornyelse: 18. december 2018
English: • Make your child eat it straight away.
Danish: • Få barnet til at spise det med det samme.
English: Do not take more than 3 sachets per day.
Danish: Tag ikke mere end 3 breve dagligt.
English: Date of first authorisation: 07 April 2014.
Danish: Dato for første markedsføringstilladelse: 07. April 2014.
English: It is especially important to tell your doctor if you are taking any of the following:
Danish: Det er særlig vigtigt, at du fortæller det til lægen, hvis du tager noget af følgende:
English: Treatment should be stopped immediately in this case.
Danish: Behandlingen bør i så fald straks seponeres.
English: • Drink straight away
Danish: • Drik det med det samme.
English: This leaflet was last revised in Other sources of information
Danish: Denne indlægsseddel blev senest ændret i Andre informationskilder
English: Treatment is usually given for two years (24 months).
Danish: Behandlingstiden er sædvanligvis to år (24 måneder).
English: There is no experience with overdose in humans.
Danish: Der foreligger ingen erfaring med overdosering hos mennesker.
English: Use in infants, children and adolescents
Danish: Brug til spædbørn, børn og unge
English: • if you are infected with HIV
Danish: • hvis du er smittet med HIV.
English: • crystals in urine.
Danish: • krystaller i urinen.
English: Triglyceride absorption is always normal.
Danish: Absorptionen af triglycerider er altid normal.
English: Wait until the next dose is due, then take your normal dose.
Danish: Vent, til du skal have næste dosis, og tag så den normale dosis.
English: The acetylation process is not genetically determined as is the case for isoniazid.
Danish: Acetyleringsprocessen er ikke genetisk bestemt, som det er tilfældet for isoniazid.
English: • nerve damage in the hands and feet,
Danish: • nervebeskadigelse i hænder og fødder,
English: The optimal dose regimen in children is uncertain.
Danish: Den optimale dosis til børn er usikker.
English: Limited pharmacokinetic data suggest no substantial difference between adults and children.
Danish: De begrænsede farmakokinetiske data tyder ikke på, at der er væsentlig forskel mellem voksne og børn.
English: 4 g (one sachet) three times per day.
Danish: 4 g (ét brev) tre gange dagligt.
English: This is because small amounts of the medicine can pass into mother's milk.
Danish: Dette skyldes, at små mængder af lægemidlet kan gå over i modermælken.
English: • You may notice granules appearing in your stools; this is normal.
Danish: • Du vil kunne se rester af granulatet i afføringen; dette er normalt.
English: Reactions are rare after a total dosage of 1.5 g.
Danish: Der forekommer sjældent reaktioner efter en total dosis på 1,5 g.
English: The recommended schedule is 4 g every 8 hours.
Danish: Den anbefalede dosisplan er 4 g hver 8. time.
English: Together they constitute more than 90% of the total metabolites of PAS found in urine.
Danish: Tilsammen udgør de over 90 % af alle metabolitter af PAS, der findes i urinen.
English: Your physician may need to start with a lower dose to prevent possible side effects.
Danish: Lægen kan finde det nødvendigt at begynde med en lavere dosis for at undgå eventuelle bivirkninger.
English: A dosing spoon is provided to measure small doses below 4 g for young children.
Danish: Der medfølger en doseringsske til måling af små doser under 4 g til små børn.
English: Other malformations were observed; however, the exact nature of these findings is unknown.
Danish: Der iagttoges andre misdannelser, men arten af disse fund kendes ikke nøjagtigt.
English: • red spots on the skin,
Danish: • røde pletter på huden,
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidigt.
English: Not known side effects (frequency cannot be estimated from the available data): • Hepatitis.
Danish: Ikke kendt bivirkninger (kan ikke estimeres ud fra forhåndenværende data): • hepatitis
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan desuden indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indberette bivirkninger kan du medvirke til at skaffe flere oplysninger om sikkerheden af dette lægemiddel.
English: If you experience any of these symptoms, you must contact to your doctor immediately.
Danish: Hvis du kommer ud for nogen af disse symptomer, skal du straks kontakte lægen.
English: • If some granules are left in the glass, add some more juice and drink straight away.
Danish: • Hvis der er granulat tilbage i glasset, skal du tilsætte mere juice og drikke det med det samme.
English: Maximum daily dose is 12 g. Usual duration of treatment is 24 months.
Danish: Den maksimale daglige dosis er 12 g. Behandlingstiden er sædvanligvis 24 måneder.
English: Each box contains 30 sachets.
Danish: Hver karton indeholder 30 breve.
English: The recommended total dose per day is 150 mg for each kg of body weight.
Danish: Den anbefalede daglige totaldosis er 150 mg pr. kg legemsvægt.
English: If you forget to take a dose of GRANUPAS
Danish: Hvis du har glemt at tage en dosis GRANUPAS
English: Cutaneous hypersensitivity reactions were also frequent as well as adverse reactions related to the nervous system.
Danish: Kutane hypersensitivitetsreaktioner var også hyppige, ligesom bivirkninger relateret til nervesystemet.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Danish: Ikke-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet efter gentagne doser.
English: Use of GRANUPAS is not recommended in newborn babies (under 28 days of age).
Danish: GRANUPAS frarådes til nyfødte (under 28 dage gamle).
English: Ethionamide should be withdrawn if these effects are significant.
Danish: Ethionamid bør seponeres, hvis disse bivirkninger forekommer i nævneværdig grad.
English: In the event of overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse reactions and that appropriate symptomatic treatment is instituted immediately.
Danish: I tilfælde af overdosering anbefales det at monitorere patienten for tegn eller symptomer på bivirkninger og straks indlede en passende symptomatisk behandling.
English: Under neutral conditions as are found in the small intestine or in neutral foods, the acid-resistant coating is dissolved within one minute.
Danish: Under neutrale betingelser som i tyndtarmen eller i neutrale fødemidler opløses den syrebestandige coating inden for 1 minut.
English: The plasma half-life of this agent is about 1 hour, the concentration is not substantially altered in hepatic dysfunction.
Danish: Plasmahalveringstiden for stoffet er ca. en time, og koncentrationen er ikke væsentligt ændret ved hepatisk dysfunktion.
English: Take the correct amount as prescribed by your doctor.
Danish: Tag den mængde, lægen har ordineret.
English: Sachets consisting of paper/low density polyethylene/aluminium foil/primer/low density polyethylene.
Danish: Breve af papir/low density polyethylen/aluminiumfolie/primer/low density polyethylen.
English: The dose in infants, children and adolescents will be calculated by your doctor based on the patient's body weight.
Danish: Dosis til spædbørn, børn og unge vil af lægen blive beregnet ud fra patientens legemsvægt.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedspersoner opfordres til at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Studies in animals have shown some reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har påvist nogen reproduktionstoksicitet (se pkt.
English: Hypothyroidism in HIV co-infected patients
Danish: Hypothyreoidisme i HIV-smittede patienter
English: • reduced ability to absorb nutrients from food ulcer,
Danish: • nedsat evne til at optage næringsstoffer fra føden,
English: It should be drunk at once ensuring that the granules are not left in the glass.
Danish: Det skal drikkes straks, og man skal påse, at der ikke er granulat tilbage i glasset.
English: • disturbance of gait and equilibrium.
Danish: • gang- eller ligevægtsforstyrrelser.
English: • Antituberculosis medicines or ethionamide (other treatments against tuberculosis)
Danish: • Ethionamid eller andre lægemidler mod tuberkulose
English: For infants, children and adolescents the dosage will be adapted to the patient's weight at 150 mg/kg per day, divided in two intakes.
Danish: Til spædbørn, børn og unge skal dosis tilpasses patientens vægt med 150 mg/kg/dag fordelt på to doser.
English: (*) in subjects also infected with HIV thyroid gland problems and specifically underactive thyroid or low levels of thyroid hormones, are a very common side effect that may affect more than 1 in 10 people.
Danish: (*) hos personer,der også er smittet med HIV og har problemer med skjoldbruskkirtlen specielt en underaktiv skjoldbruskkirtel eller som har lave niveauer af skjoldbruskkirtlens hormoner, er det en meget almindelig bivirkning, der kan påvirke mere end 1 af 10 personer.
English: Do not store above 25°C.
Danish: Må ikke opbevares over 25º C.
English: Regular monitoring of the thyroid function is indicated for all people living with HIV.
Danish: En regelmæssig overvågning af skjoldbruskkirtlens funktion er indiceret hos personer, som lever med HIV.
English: Pharmacotherapeutic group: Antimycobacterials, drugs for treatment of tuberculosis, ATC code: J04AA01
Danish: Farmakoterapeutisk klassifikation: Antimycobacterica, stoffer til behandling af tuberkulose, ATCkode: J04AA01
English: • if you have liver problems or mild or moderate kidney disease
Danish: • hvis du har leverproblemer eller let til moderat nyresygdom
English: The lack of a dose-response relationship suggests that the findings are not of clinical relevance, but it is noted that the findings were observed at doses below those proposed clinically.
Danish: Den manglende dosis-responssammenhæng tyder på, at resultaterne er uden klinisk relevans, men det må bemærkes, at fundene blev iagttaget ved doser under de påtænkte kliniske doser.
English: Bone defects were observed at 77 mg/kg only.and increased foetal weight was noted at the other doses.
Danish: Knogledefekter blev kun iagttaget ved 77 mg/kg, mens der sås øget fostervægt ved de andre doser.
English: Results indicate that para-aminosalicylic acid was considered not to have produced any clastogenic effect in mice treated at non-toxic dose levels (examined 24 hours after 2 daily administrations of 312.5 to 1250 mg/kg).
Danish: Resultaterne indikerer, at para-aminosalicylsyre blev anset for ikke at have givet nogen klastogen effekt hos mus behandlet med ikke-toksiske doser (undersøgt 24 timer efter 2 daglige administrationer 312,5 til 1250 mg/kg).
English: It is unknown whether it passes through the placental barrier.
Danish: Det vides ikke, om stoffet passerer placentabarrieren.
English: In the table below all adverse reactions are listed by system organ class and by frequency.
Danish: I nedenstående tabel er alle bivirkninger opstillet efter systemorganklasse og hyppighed.
English: • Use the spoon that comes with the medicine to measure the dose.
Danish: • Brug den medfølgende ske til at måle dosis.
English: • To measure the dose: o Lines on the spoon indicate the amount (in milligrams of para-aminosalicylic acid).
Danish: • Måling af dosis: o Linjerne på skeen angiver mængden (i milligram para-aminosalicylsyre).
English: *see Description of selected adverse reactions below Description of selected adverse reactions
Danish: *Se beskrivelsen af udvalgte bivirkninger nedenfor Beskrivelse af udvalgte bivirkninger Hypothyroidism
English: • if you have a stomach ulcer
Danish: • hvis du har mavesår
English: GRANUPAS is unlikely to affect your ability to drive any vehicle and use machines.
Danish: GRANUPAS forventes ikke at påvirke din evne til at føre køretøj eller betjene maskiner.
English: The patient must be monitored carefully during the first three months of therapy and treatment must be discontinued immediately at the first sign of a rash, fever or other premonitory signs of intolerance.
Danish: Patienten skal overvåges nøje under de første tre måneder af behandlingen, som straks skal seponeres ved første tegn på udslæt, feber eller andre tegn, der varsler intolerance.
English: The medicinal product should be swallowed immediately after mixing with orange juice, tomato juice, apple sauce and yogurt whilst the granules are intact.
Danish: Lægemidlet skal synkes straks efter opslæmning i appelsinjuice, tomatjuice, æblemos eller yoghurt, mens kornene af granulat er intakte.
English: Plasma protein binding is about 50 to 60%, the kinetic distribution has a half-life of 0.94 hours and a volume of distribution of 1.001 L/kg.
Danish: Plasmaproteinbindingen er ca. 50 til 60 %, den kinetiske fordeling har en halveringstid på 0,94 timer, og fordelingsvolumenet er 1,001 l/kg.
English: It inhibits the onset of bacterial resistance to streptomycin and isoniazid.
Danish: Det hæmmer indsætten af bakteriel resistens over for streptomycin og isoniazid.
English: to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden 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) eller ikke kendt (kan ikke beregnes af forhåndenværende data).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet i rækkefølge efter aftagende alvorlighed.
English: The cumulative excretion of para-aminosalicylic after 24 hours is 84% of an oral dose of 4 g, 21% as para-aminosalicylic acid and 63% as the acetylated form.
Danish: Den kumulative udskillelse af para-aminosalicylsyre efter 24 timer udgør 84 % af en oral dosis på 4 g, 21 % som para-aminosalicylsyre og 63 % som den acetylerede form.
English: Lucane Pharma 172 rue de Charonne 75011 Paris France
Danish: Lucane Pharma 172 rue de Charonne 75011 Paris Frankrig
English: The granules should not be crushed or chewed, as this impairs the gastro-resistant coating.
Danish: Granulatet må ikke knuses eller tygges, da dette kan beskadige den gastro-resistente coating.
English: GRANUPAS can be taken with food.
Danish: GRANUPAS kan indtages sammen med et måltid.
English: See section 4.2 for posology adjustments for desensitization.
Danish: 4.2 vedrørende dosisjustering med henblik på desensibilisering.
English: Patients should be advised that the skeletons of the granules may be seen in the stools.
Danish: Patienterne bør oplyses om, at der kan ses rester af granulat i afføringen.
English: During the first 3 months of your treatment with GRANUPAS, you must be attentive to any sign of allergic reaction (for example skin eruption, itchy red spots on the skin, itching, rash, watery or itchy eyes or stuffy nose) or hepatitis (for example fever, fatigue, dark urine, pale stool, abdominal pain, yellow skin and eyes).
Danish: I løbet af de første tre måneder af behandlingen med GRANUPAS skal du være opmærksom på ethvert tegn på overfølsomhedsreaktion (såsom hududslæt, kløende røde pletter på huden, kløe, udslæt, øjne der løber i vand eller klør, tilstoppet næse) eller leverbetændelse (såsom feber, træthed, mørk urin, bleg afføring, mavesmerter, gul hud og øjne).
English: As there are no adequate and well controlled studies of para- aminosalicylic acid in humans, para-aminosalicylic acid should be given to a pregnant woman only if clearly needed.
Danish: Da der ikke foreligger tilstrækkelige og velkontrollerede undersøgelser af para-aminosalicylsyre hos mennesker, bør para-aminosalicylsyre kun gives til gravide kvinder, hvis der er klart behov for det.
English: The dosage is doubled every 2 days until reaching a total of 1 gram after which the dosage is divided to follow the regular schedule of administration.
Danish: Doseringen fordobles hver anden dag til i alt 1 g, hvorefter dosis opdeles i henhold til den normale doseringsplan.
English: The first symptoms usually appear within three months of the start of therapy with a rash as the most common adverse reaction followed by fever and much less frequently by gastrointestinal disturbances of anorexia, nausea or diarrhoea.
Danish: De første symptomer indtræder sædvanligvis inden for tre måneder efter påbegyndelse af behandlingen, hvor udslæt er den hyppigste bivirkning, efterfulgt af feber og langt mindre hyppigt gastrointestinale gener bestående i anoreksi, kvalme eller diarré.
English: If a mild temperature rise or skin reaction develops, the increment is to be dropped back one level or the progression held for one cycle.
Danish: Hvis der opstår let temperaturstigning eller hudreaktion, sættes dosisforøgelsen et trin ned, eller dosisforøgelsen springes over i én cyklus.
English: In human lymphocyte cultures in-vitro clastogenic effects of achromatic, chromatid, isochromatic breaks or chromatid translocations were not seen at 153 or 600 µg /mL but at 1500 and 3000 µg /mL there was a dose related increase in chromatid aberrations.
Danish: I in vitro kulturer af humane lymfocytter sås ikke klastogene virkninger i form af akromatiske brud, kromatid og isokromatid brud eller kromatidtranslokationer ved 153 eller 600 µg/ml, men ved 1 500 og 3 000 µg/ml var der dosisafhængig stigning i kromatidaberrationer.
English: 1244 RL Ankeveen The Netherlands
Danish: 1244 RL Ankeveen Holland
English: Uncommon side effects (may affect more than 1 in 1,000 people): • loss of appetite (anorexia).
Danish: Ikke almindelige bivirkninger (forekommer hos mere end 1 ud af 1 000 behandlede): • nedsat appetit (anoreksi).
English: This daily amount is divided into two doses spread out through the day.
Danish: Den daglige mængde skal gives som to doser, der fordeles over døgnet.
English: The drug does not cross the blood brain barrier in patients unless the meninges are inflamed, when the concentration of para-aminosalicylic acid in cerebrospinal fluid is about 10 to 50% of the plasma.
Danish: Stoffet passerer ikke blod-hjernebarrieren hos patienterne undtagen ved inflammation af meninges, i hvilket tilfælde koncentrationen af para-aminosalicylsyre i cerebrospinalvæsken er ca. 10 til 50 % af plasmakoncentrationen.
English: Desensitization can be accomplished by starting with 10 mg para-aminosalicylic acid (PAS) given as a single dose.
Danish: Desensibilisering kan opnås ved at begynde med 10 mg para-aminosalicylsyre (PAS) som en enkelt dosis.
English: o Put granules directly into the spoon.
Danish: o Hæld granulatet direkte i skeen.
English: The data available from a rat embryofoetal development study, where animals were given sodium aminosalicylate (3.85 to 385 mg/kg) were limited.
Danish: Der foreligger begrænsede data fra en embryoføtal udviklingsundersøgelse hos rotter, som blev indgivet natriumaminosalicylat (3,85 til 385 mg/kg).
English: • reduction of the ability of red blood cells to release oxygen
Danish: • reduktion af de røde blodlegemers evne til at frigive ilt,
English: Any granules left-over at the bottom of the glass should be swallowed immediately by adding a small quantity of liquid.
Danish: Eventuelt tilbageværende granulat i bunden af glasset skal synkes straks efter tilføring af en lille mængde væske.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin, har gjort det for nylig eller påtænker at gøre det.
English: • prolonged bleeding time,
Danish: • forlænget blødningstid,
English: The soft skeletons of the granules remain and may be seen in the stools.
Danish: De bløde rester af granulatkornene nedbrydes ikke og kan ses i afføringen.
English: • Do not crush or chew the granules.
Danish: • Undlad at knuse eller tygge granulatet.
English: Methacrylic acid - Ethyl acrylate copolymer (1:1) Dispersion 30 per cent Hypromellose
Danish: Methacrylsyre-ethylacrylat copolymer (1:1) dispersion 30 % Hypromellose
English: Contents of the pack and other information What GRANUPAS contains
Danish: Pakningsstørrelser og yderligere oplysninger GRANUPAS indeholder:
English: Small amounts of this agent are distributed in the milk and bile.
Danish: Små mængder af stoffet fordeles i mælk og galde.
English: o Tap the spoon once on a table to give a horizontal level of granules and continue filling if necessary.
Danish: o Bank skeen let mod bordet, så overfladen af granulatet bliver vandret, og fyld efter om nødvendigt.
English: Smaller doses in children should be measured using the dosing spoon and given by sprinkling on apple sauce or yogurt.
Danish: Mindre doser til børn kan afmåles med doseringsskeen og gives ved at drysse granulatet på æblemos eller yoghurt.
English: The recommended dose for adults is 1 sachet three times a day, with a schedule of 1 sachet every 8 hours.
Danish: Den anbefalede dosis til voksne er 1 brev tre gange dagligt, fordelt med 1 brev hver 8. time.
English: However, para-aminosalicylic acid appears to be a weak inhibitor of DHP in vitro, raising the possibility that it may have a different target.
Danish: Para-aminosalicylsyre er imidlertid en svag hæmmer af DHP in vitro, hvilket gør det sandsynligt, at det kan have et andet mål.
English: It is important that you do not dissolve, crush or chew the granules as they may not absorb properly and may cause stomach ache or bleeding.
Danish: knuser eller tygger granulatet, da det måske ikke vil blive absorberet korrekt og kan give mavesmerter eller maveblødning.
English: If you are not sure, talk to your doctor or pharmacist before taking GRANUPAS.
Danish: Hvis du er i tvivl, skal du tale med lægen eller apotekspersonalet, inden du tager GRANUPAS.
English: Aminosalicylic acid is bacteriostatic against Mycobacterium tuberculosis.
Danish: Aminosalicylsyre virker bakteriostatisk over for Mycobacterium tuberculosis.
English: A calibrated measuring spoon is provided.
Danish: Der medfølger en kalibreret måleske.
English: Para-aminosalicylic acid may cause hepatitis.
Danish: Para-aminosalicylsyre kan forårsage hepatitis.
English: In case it does, please report it to your doctor or pharmacist.
Danish: Hvis det gør, fortæl det venligst til din læge eller på apoteket.
English: • low levels of blood sugar,
Danish: • lavt blodsukker,
English: Speak to a doctor or pharmacist.
Danish: Tal med lægen eller apotekspersonalet.