natgillin/translations-raw huggingface dataset:
Hvis patienten er skiftet fra et andet lægemiddel mod diabetes, er den anbefalede startdosis 1 mg. Repaglinid Accord anbefales ikke til patienter under 18 år på grund af manglende data om sikkerhed og virkning i denne aldersgruppe.
Repaglinide Accord is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Patientens blodglukose skal regelmæssigt kontrolleres af en
A doctor should regularly test the patient's blood glucose to find the lowest effective dose.
Hvad er Repaglinid Accord?
What is Repaglinide Accord?
Hvorfor blev Repaglinid Accord godkendt?
Why has Repaglinide Accord been approved?
Hvordan blev Repaglinid Accord undersøgt?
How has Repaglinide Accord been studied?
Hvad anvendes Repaglinid Accord til?
What is Repaglinide Accord used for?
Hvordan anvendes Repaglinid Accord?
How is Repaglinide Accord used?
Repaglinid Accord kan også anvendes til patienter med type 2-diabetes, hvis blodglukoseniveau normalt kontrolleres tilfredsstillende med diæt, men hvor blodglukosen midlertidigt ikke er under kontrol.
blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Indhold (Koncentration)
<Content (concentration)>
3 NHBA (Neisserial heparinbindende antigen), NadA (Neisseria adhesin A), fHbp (faktor H-bindende protein)
3 NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein)
1 produceret i E. coli-celler ved rekombinant DNA-teknologi 2 adsorberet på aluminiumhydroxid (0,5 mg Al³+)
1 produced in E. coli cells by recombinant DNA technology 2 adsorbed on aluminium hydroxide (0.5 mg Al3+)
--1 Én dosis (0,5 ml) indeholder: Rekombinant Neisseria meningitidis gruppe B NHBA-fusionsprotein 1, 2, 3
--1 One dose (0.5 ml) contains: Recombinant Neisseria meningitidis group B NHBA fusion protein 1, 2, 3
10 fyldte injektionssprøjter uden kanyler
10 pre-filled syringes without needles
10 fyldte injektionssprøjter med kanyler
10 pre-filled syringes with needles
1 fyldt injektionssprøjte uden kanyler
1 pre-filled syringe without needles
1 fyldt injektionssprøjte med kanyler
1 pre-filled syringe with needles
Behandlingen fortsættes sædvanligvis i to år.
Treatment is usually continued for 2 years.
Lægemidlets navn blev ændret til Granupas den 15. maj 2014.
The name of the medicine was changed to Granupas on 15 May 2014.
Den første omfattede 166 tuberkulosepatienter i alderen 15-30 år.
The first of these involved 166 patients with tuberculosis aged between 15 to 30 years.
Der gives i alt 150 mg/kg legemsvægt pr. dag, fordelt på to doser.
They should be given a total of 150 mg per kilogram body weight every day, split into two doses.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Para-aminosalicylsyre Lucane den 7. april 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Para-aminosalicylic acid Lucane on 7 April 2014.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Granupas.
This is a summary of the European public assessment report (EPAR) for Granupas.
Den anbefalede dosis til voksne er ét brev tre gange dagligt.
The recommended dose for adults is one sachet three times a day.
PAS har været anvendt i mange år i EU til kombinationsbehandling af tuberkulose.
PAS has been used for many years in the EU for the combination treatment of tuberculosis.
Andre oplysninger om Granupas
Other information about Granupas
Der er udarbejdet en risikostyringsplan for at sikre, at Granupas anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Granupas is used as safely as possible.
Granupas må ikke anvendes af patienter med svært nedsat nyrefunktion.
Granupas must not be taken by patients with severely reduced kidney function.
Det anvendes i kombination med andre lægemidler til behandling af voksne og børn i alderen 28 dage og derover med multiresistent tuberkulose, når kombinationsbehandlinger uden dette lægemiddel ikke kan anvendes, enten fordi sygdommen er resistent over for dem eller på grund af deres bivirkninger.
It is used in combination with other medicines to treat adults and children from 28 days of age who have multi-drug resistant tuberculosis when combinations without this medicine cannot be used, either because the disease is resistant to them or because of their side effects.
De hyppigste bivirkninger ved Granupas (som kan forekomme hos op til 1 ud af 10 personer) er mavesmerter, opkastning, kvalme, oppustethed, diarré og blød afføring, svimmelhed, gang- og balanceforstyrrelser, allergiske hudreaktioner og udslæt.
The most common side effects with Granupas (which may affect up to 1 in 10 people) are abdominal pain (stomach ache), vomiting, nausea, bloating, diarrhoea and soft stools, giddiness, disturbance in gait and balance, and allergic skin reactions and rash.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Granupas opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Granupas's benefits are greater than its risks and recommended that it be approved for use in the EU.
Da antallet af patienter med tuberkulose er lavt i EU, betragtes sygdommen som »sjælden«, og Granupas blev udpeget som »lægemiddel til sjældne sygdomme« den 17. december 2010.
Because the number of patients with tuberculosis is low in the EU, the disease is considered ‘rare', and Granupas was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 December
Hos børn og voksne fastsættes den daglige dosis efter legemsvægten.
In children and adolescents, the daily dose depends on their weight.
Granupas er et lægemiddel mod tuberkulose og indeholder det aktive stof para-aminosalicylsyre (PAS).
Granupas is a tuberculosis medicine that contains the active substance para-aminosalicylic acid (PAS).
Patienterne blev behandlet i 3 måneder enten med PAS eller et andet lægemiddel, streptomycin, eller med en kombination af PAS og streptomycin og blev derefter fulgt op i yderligere 3 måneder.
The patients were treated for 3 months with either PAS or another medicine called streptomycin, or with a combination of PAS and streptomycin, and then followed up for 3 extra months.
Der medfølger doseringsske til måling af små doser til små børn.
A dosing spoon is used to measure small doses for young children.
Ansøgeren forelagde publicerede data om de doser af PAS, der skal anvendes hos børn.
The applicant also provided published data on the doses of PAS to be used in children.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Granupas?
What measures are being taken to ensure the safe and effective use of Granupas?
Hvad er Granupas, og hvad anvendes det til?
What is Granupas and what is it used for?
PAS har tidligere været udbredt til kombinationsbehandling, men er stort set gået ud af brug på grund af bivirkninger fra maven.
PAS had been widely used in the past for combination treatment but was largely discontinued due to adverse effects on the stomach.
Multiresistens vil sige, at tuberkulosebakterien (Mycobacterium tuberculosis) er resistent over for behandling med mindst isoniazid og rifampicin, som er to standardlægemidler mod tuberkulose.
Multi-drug resistance is when the bacteria causing tuberculosis (Mycobacterium tuberculosis) are resistant to treatment with at least isoniazid and rifampicin, two standard tuberculosis medicines.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Granupas, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Granupas, including the appropriate precautions to be followed by healthcare professionals and patients.
Hvorfor blev Granupas godkendt?
Why is Granupas approved?
Granupas udleveres kun efter recept.
Granupas can only be obtained with a prescription.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Granupas findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Granupas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
I den anden hovedundersøgelse med 341 patienter over 12 år blev en kombination af PAS og isoniazid sammenlignet med isoniazid alene.
In the second main study involving 341 patients aged over 12 years, PAS in combination with isoniazid was compared with isoniazid alone.
Granupas para-aminosalicylsyre
para-aminosalicylic acid
Udvalget bemærkede, at det aktive stof, PAS, er påvist at være gavnligt, når det anvendes i kombination med andre lægemidler til behandling af tuberkulose, og at det mindsker opståen af resistens over for andre lægemidler.
The Committee noted that the active substance, PAS, has been shown to be beneficial when used in combination with other medicines to treat tuberculosis and that it helps reduce the emergence of resistance to other medicines.
Udvalget bemærkede desuden, at Verdenssundhedsorganisationen fortsat anbefaler mulig anvendelse af PAS i kombination med andre lægemidler til behandling af multiresistent tuberkulose.
The Committee also noted that the World Health Organization continues to recommend PAS as an option to be used in combination with other medicines for treating multi-drug resistant tuberculosis.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Granupas findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Granupas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Hvis du ønsker yderligere oplysninger om behandling med Granupas, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Granupas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det er ikke en praktisk vejledning i, hvordan Granupas bør anvendes.
It is not intended to provide practical advice on how to use Granupas.
PAS ligner et kemisk stof (paraaminobenzoesyre), som bakterierne anvender til at producere folsyre, der er nødvendigt for vækst af nye bakterier.
PAS is similar to a chemical (para-aminobenzoic acid) that is used by the bacteria to make folic acid needed for new bacteria to grow.
Hvilke risici er der forbundet med Granupas?
What are the risks associated with Granupas?
Det aktive stof, PAS, er »bakteriostatisk«, dvs. det virker ved at standse væksten af bakterien M. tuberculosis.
The active substance, PAS, is a ‘bacteriostatic agent', which means that it works by stopping the growth of M. tuberculosis bacteria.
Det leveres som breve på 4 g, der indeholder et enterogranulat, som tillader det aktive stof at nå frem til tarmen, uden at det frigives i mavesækken, hvorved bivirkningerne fra maven mindskes.
It is available as 4 g sachets containing ‘gastroresistant' granules that allow the active substance to reach the intestine without being released in the stomach, thus reducing side effects in the stomach.
Virksomheden fremlagde publicerede undersøgelser, der viser fordelene ved kombination med andre tuberkulosemidler, hvor to af undersøgelserne blev anset for at være hovedgrundlag for ansøgningen.
The benefits in combination with other tuberculosis treatments were shown in published studies presented by the company, two of which were considered to be the main studies for the application.
Tidligere kendt som Para-aminosalicylsyre Lucane.
Previously known as Para-aminosalicylic acid Lucane
CHMP bemærkede, at Granupas indeholder et enterogranulat, som tillader PAS at nå frem til tarmen, uden at det frigives i mavesækken, hvorved de mulige bivirkninger nedsættes.
The CHMP noted that Granupas contains gastro-resistant granules, designed to allow PAS to reach the intestine without being released in the stomach, and thus reduce the potential for side effects.
Efter 12 måneder havde 90 % af patienterne i kombinationsgruppen ikke bakterierne i deres ophostede slim, sammenholdt med 51 % af dem, der kun fik en sammenlignelig dosis af isoniazid.
After 12 months, 90% of patients in the combination group did not have the bacteria in their phlegm compared with 51% of patients given a comparable dose of isoniazid alone.
PAS kombineret med streptomycin nedsatte også opståen af resistens over for streptomycin: Hos 89 % af de patienter, der fik kombinationsbehandlingen, forblev bakterierne følsomme over for streptomycin, sammenholdt med 21 % af dem, der kun fik streptomycin.
PAS in combination with streptomycin also helped reduce the emergence of resistance to streptomycin: in 89% of patients receiving the combination the bacteria remained responsive to streptomycin, compared with 21% of patients who were given only streptomycin.
Den fuldstændige liste over indberettede bivirkninger ved Granupas fremgår af indlægssedlen.
For the full list of all side effects reported with Granupas, see the package leaflet.
PAS kombineret med isoniazid nedsatte desuden opståen af resistens over for isoniazid: Efter 1 år var der resistente bakterier hos 47 % af patienterne i den gruppe, der kun fik isoniazid, mod 8 % i kombinationsgruppen.
In addition, the PAS-isoniazid combination helped reduce the emergence of resistance to isoniazid: after 1 year, while 47% of patients in the isoniazid-only group had resistant bacteria the figure was only 8% in the combination group.
Desuden havde 33 % af patienterne i kombinationsgruppen ingen bakterier i deres ophostede slim, sammenholdt med 8 % i gruppen på PAS.
In addition,33% of patients in the combination group had no bacteria detected in their phlegm (sputum) compared with 8% in the PAS group.
Hvis du ønsker praktisk vejledning om anvendelsen af Granupas, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Granupas, patients should read the package leaflet or contact their doctor or pharmacist.
Para-aminosalicylsyre indtager paraaminobenzoesyres plads i de processer, hvor der dannes folsyre, og nedsætter derved den mængde folsyre, der dannes, således at væksten af M. tuberculosis standses eller bremses.
By interfering and taking the place of this chemical in the processes that make folic acid, para-aminosalicylic acid reduces the amount of folic acid produced and thereby stops or slows the growth of M. tuberculosis.
Hvilke fordele viser undersøgelserne, at der er ved Granupas?
What benefits of Granupas have been shown in studies?
Efter 6 måneder viste røntgen af brystkassen bedring hos 87 % af patienterne på kombinationen, sammenholdt med 56 % af patienterne i den gruppe, der kun fik PAS.
At the end of the 6 months, 87% of patients on the combination had improvements in their chest x-rays compared with 56% of patients in the group taking PAS alone.
Hvordan anvendes Granupas?
How is Granupas used?
Hvordan virker Granupas?
How does Granupas work?
• voksne (på 18 år og derover) med mild til moderat Gauchers sygdom type 1.
• adults (aged 18 years and above) with mild to moderate type-1 Gaucher disease.
Miglustat Gen.Orph fik en markedsføringstilladelse med gyldighed i hele EU den 10. november 2017.
Miglustat Gen.Orph received a marketing authorisation valid throughout the EU on 10 November 2017.
Yderligere information vedrørende Miglustat Gen.Orph findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/miglustat-genorph.
Further information on Miglustat Gen.Orph can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/miglustat-genorph.
Lægemidlet fås kun på recept, og behandlingen bør følges af læger med erfaring i håndtering af Gauchers sygdom.
The medicine can only be obtained with a prescription and treatment should be supervised by doctors who are experienced in the management of Gaucher disease.
• patienter i alle aldre med Niemann-Picks sygdom type C, en potentielt dødelig sygdom, hvor der ophobes glycosphingolipider i hjerneceller og celler andre steder i kroppen.
• patients of all ages with Niemann-Pick type-C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body.
Ved at forhindre enzymet i at virke kan miglustat mindske produktionen af glucosylceramid i cellerne og derved reducere symptomerne på Gauchers sygdom type 1.
By preventing the enzyme from working, miglustat can reduce the production of glucosylceramide in cells, thereby reducing the symptoms of type-1 Gaucher disease.
Da Miglustat Gen.Orph er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
Because Miglustat Gen.Orph is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Det betyder, at Miglustat Gen.Orph indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Zavesca.
This means that Miglustat Gen.Orph contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Zavesca.
Miglustat Gen.Orph anvendes til behandling af de neurologiske symptomer på sygdommen (symptomer, der påvirker hjernen og nerverne).
Miglustat Gen.Orph is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Miglustat Gen.Orph er af sammenlignelig kvalitet og er bioækvivalent med Zavesca.
The European Medicines Agency concluded that, in accordance with EU requirements, Miglustat Gen.Orph has been shown to have comparable quality and to be bioequivalent to Zavesca.
Begge sygdomme forårsager en ophobning i kroppen af fedtstoffer, der kaldes glycosphingolipider.
Both diseases cause a build-up of fatty substances called glycosphingolipids in the body.
Hvis du ønsker mere information om anvendelsen af Miglustat Gen.Orph, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Miglustat Gen.Orph, see the package leaflet or contact your doctor or pharmacist.
Miglustat Gen.Orph anvendes til behandling af to arvelige sygdomme, der påvirker den måde, kroppen håndterer fedt på.
Miglustat Gen.Orph is used to treat two inherited diseases that affect the way the body handles fats.
De indberettede bivirkninger ved Miglustat Gen.Orph vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Miglustat Gen.Orph are carefully evaluated and any necessary action taken to protect patients.
Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Miglustat Gen.Orph.
As for every medicine, the company provided studies on the quality of Miglustat Gen.Orph.
Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet Zavesca, og de behøver ikke blive gentaget for Miglustat Gen.Orph.
Studies on the benefits and risks of the active substance in Gaucher disease have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Miglustat Gen.Orph.
Som for alle lægemidler bliver data vedrørende brug af Miglustat Gen.Orph løbende overvåget.
As for all medicines, data on the use of Miglustat Gen.Orph are continuously monitored.
Det aktive stof i Miglustat Gen.Orph, miglustat, blokerer virkningen af enzymet glucosylceramidsyntase.
The active substance in Miglustat Gen.Orph, miglustat, blocks an enzyme called glucosylceramide synthase.
Miglustat Gen.Orph fås som 100 mg-kapsler, der tages gennem munden.
Miglustat Gen.Orph is available as 100 mg capsules to be taken by mouth.
Miglustat Gen.Orph anvendes til patienter, der ikke kan få standardbehandling med enzymsubstitutionsterapi (ERT)
Miglustat Gen.Orph is used in patients who cannot receive the standard treatment of enzymereplacement therapy (ERT);
Andre oplysninger om Miglustat Gen.Orph
Other information about Miglustat Gen.Orph
Det var derfor agenturets opfattelse, at fordelene ved Miglustat Gen.Orph opvejer de identificerede risici som for Zavesca, og at det kan godkendes til anvendelse i EU.
Therefore, the Agency's view was that, as for Zavesca, the benefit of Miglustat Gen.Orph outweighs the identified risk and it can be authorised for use in the EU.
Miglustat Gen.Orph anvendes til behandling af følgende patienter:
Miglustat Gen.Orph is used to treat the following patients:
Miglustat Gen.Orph er et "generisk lægemiddel".
Miglustat Gen.Orph is a ‘generic medicine'.
Oversigt over Miglustat Gen.Orph, og hvorfor det er godkendt i EU
An overview of Miglustat Gen.Orph and why it is authorised in the EU
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Miglustat Gen.Orph?
What measures are being taken to ensure the safe and effective use of Miglustat Gen.Orph?
Hvad er Miglustat Gen.Orph, og hvad anvendes det til?
What is Miglustat Gen.Orph and what is it used for?
Hvilke fordele og risici er der forbundet med Miglustat Gen.Orph?
What are the benefits and risks of Miglustat Gen.Orph?
Hvorfor blev Miglustat Gen.Orph godkendt i EU?
Why is Miglustat Gen.Orph authorised in the EU?
Miglustat Gen.Orph er beregnet til langtidsbehandling.
Miglustat Gen.Orph is intended for long-term use.
Det medfører, at et glycosphingolipid kaldet glucosylceramid ophobes forskellige steder i kroppen, f.eks. i milten, leveren og knoglerne.
Patients with this disease lack an enzyme called glucocerebrosidase, which results in a glycosphingolipid called glucosylceramide building up in different parts of the body, such as the spleen, liver and bones.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Miglustat Gen.Orph.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Miglustat Gen.Orph have been included in the summary of product characteristics and the package leaflet.
Hvordan blev Miglustat Gen.Orph undersøgt?
How has Miglustat Gen.Orph been studied?
Hvordan anvendes Miglustat Gen.Orph?
How is Miglustat Gen.Orph used?
Hvordan virker Miglustat Gen.Orph?
How does Miglustat Gen.Orph work?
Disse kan sædvanligvis behandles af Deres læge.
These can usually be treated by your doctor.
Dato for første markedsføringstilladelse: 19. juli 2006 Dato for seneste fornyelse: 21. juli 2011
Date of first authorisation: 19 July 2006 Date of latest renewal: 21 July 2011
Den absolutte biotilgængelighed er ikke kendt.
The absolute bioavailability is not known.
Lignende effekter opstod ikke i voksne hunde.
Similar effects were not induced in adult dogs.
Tabletterne bør sluges med et glas vand.
The tablets should be swallowed with a glass of water.
Dette lægemiddel kan også påvirke resultaterne af visse blodprøver.
This medicine may also affect the results of some blood tests.
- hvis De har et højt blodtryk.
- If you have high blood pressure.
Monitorering af nyrefunktionen bør overvejes.
Monitoring of renal function should be considered.
Alle grader*
All Grades*
Den nominelle alfa-værdi for denne analyse var 0,0094.
The nominal alpha value for this analysis was 0.0094.
- hvis De har diabetes.
- If you have diabetes.
Fortæl det til Deres læge, hvis noget af dette berører Dem.
Tell your doctor if any of these affect you.
Laboratorieparameter, (i % af undersøgte prøver)
Laboratory parameter, (in % of samples investigated)
Deres læge vil beslutte, hvornår De skal starte med Nexavar igen.
Your doctor will decide when to start with Nexavar again.