natgillin/translations-raw huggingface dataset:
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for Zavesca findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
The summaries of the opinions of the Committee for Orphan Medicinal Products for Zavesca on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
Hvorfor blev Zavesca godkendt?
Why has Zavesca been approved?
Hvilken risiko er der forbundet med Zavesca?
What is the risk associated with Zavesca?
• patienter i alle aldre med Niemann-Picks sygdom type C, en potentielt dødelig sygdom, hvor glycosphingolipider ophobes i hjerneceller og 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.
Yderligere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
For further information, see the summary of product characteristics (also part of the EPAR).
Dette enzym har betydning for det første trin i dannelsen af glycosphingolipider.
This enzyme is involved in the first step of the production of glycosphingolipids.
Den anbefalede startdosis til behandling af voksne patienter med Gauchers sygdom type 1 er en kapsel tre gange dagligt.
The recommended starting dose for type 1 Gaucher disease is one capsule three times a day.
Symptomerne omfatter tab af koordinationsevne, problemer med hurtige øjenbevægelser, hvilket kan medføre nedsat syn, forsinket udvikling, synkebesvær, nedsat muskeltonus, krampeanfald og indlæringsvanskeligheder.
These include loss of co-ordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, decreased muscle tone, fits and learning difficulties.
De hyppigste bivirkninger ved Zavesca (som optræder hos flere end 1 ud af 10 patienter) er vægttab, nedsat appetit, rysten, diarré, luft i maven og mavesmerter.
The most common side effects with Zavesca (seen in more than 1 patient in 10) are weight loss, decreased appetite, tremor (shaking), diarrhoea, flatulence (gas) and abdominal pain (stomach ache).
Zavesca til behandling af Niemann-Picks sygdom type C blev undersøgt i en hovedundersøgelse af 31 patienter, hvoraf 12 var under 12 år.
For Niemann-Pick type C disease, Zavesca was studied in one main study involving 31 patients, 12 of whom were less than 12 years old.
Patienter med denne sygdom mangler et enzym, som kaldes glucocerebrosidase, hvilket medfører ophobning af et glycosphingolipid kaldet glucosylceramid i forskellige dele af kroppen, f.eks. 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.
Det aktive stof i Zavesca, miglustat, forhindrer et enzym kaldet glucosylceramidsyntase i at virke.
The active substance in Zavesca, miglustat, prevents an enzyme called glucosylceramide synthase from working.
Ved at forhindre enzymet i at virke kan miglustat reducere dannelsen af glycosphingolipider i cellerne.
By preventing the enzyme from working, miglustat can reduce the production of glycosphingolipids in cells.
Behandlingen med Zavesca bør indledes og overvåges af læger med erfaring i behandling af patienter med Gauchers sygdom eller Niemann Picks sygdom type C.
Treatment with Zavesca should be started and monitored by doctors who are experienced in the management of Gaucher or Niemann-Pick type C disease.
Hvad er Zavesca?
What is Zavesca?
Zavesca anvendes, når patienten anses for uegnet til standardbehandling med enzymsubstitutionsbehandling,
Zavesca is used in patients who cannot receive the standard treatment of enzyme replacement therapy (ERT);
Ved begge sygdomme ophobes et fedtstof kaldet glycosphingolipid i kroppen.
Both diseases cause a build-up of fatty substances called glycosphingolipids in the body.
Den fuldstændige liste over de indberettede bivirkninger ved Zavesca fremgår af indlægssedlen.
For the full list of all side effects reported with Zavesca, see the package leaflet.
Zavescas virkning på Gauchers sygdom type 1 blev undersøgt i en hovedundersøgelse af 28 voksne med let til moderat Gauchers sygdom type 1, som ikke kunne eller ikke ville modtage enzymsubstitutionsbehandling.
For type 1 Gaucher disease, Zavesca was investigated in one main study involving 28 adults with mild to moderate disease who were unable or unwilling to receive ERT.
Zavesca blev udpeget som lægemiddel til sjældne sygdomme den 18. oktober 2000 for Gauchers sygdom type 1 og den 16. februar 2006 for Niemann Picks sygdom type C.
Because the number of patients with these diseases is low, they are considered ‘rare', and Zavesca was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 October 2000 for type 1 Gaucher disease and on 16 February 2006 for Niemann-Pick type C disease.
Hvordan blev Zavesca undersøgt?
How has Zavesca been studied?
Hvad anvendes Zavesca til?
What is Zavesca used for?
Hvilken fordel viser undersøgelserne, at der er ved Zavesca?
What benefit has Zavesca shown during the studies?
Hvordan anvendes Zavesca?
How is Zavesca used?
Den anbefalede dosis til behandling af Niemann Picks sygdom type C er to kapsler tre gange dagligt til patienter på 12 år og derover.
For Niemann-Pick type C disease, it is two capsules three times a day for patients aged 12 years and over; in younger patients, the dose depends on their weight and height.
Hvordan virker Zavesca?
How does Zavesca work?
Europa-Kommissionen traf en afgørelse den 22. august 2016.
The European Commission issued a decision on 22 August 2016.
Proceduren blev afsluttet, og den 11. juli 2014 vedtog Europa-Kommissionen en afgørelse
The procedure was concluded and on 11 July 2014 the European Commission adopted a Decision1.
Resultatet af en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/110)
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/110)
Hvad er lincomycin og spectinomycin?
What are lincomycin and spectinomycin?
Lincosamider anses for at være bakteriostatiske.
The lincosamides are considered to be bacteriostatic agents.
Det blev ikke fundet nødvendigt at ændre de aktuelt godkendte tilbageholdelsestider for svin og kyllinger for det føromtalte pulver til anvendelse i drikkevand.
No amendments to the currently approved withdrawal periods for pigs and chicken for the aforementioned powders for use in the drinking water were considered necessary.
Kommissionens afgørelse i henhold til artikel 34 i Europa-Parlamentets og Rådets direktiv 2001/82/EF angående markedsføringstilladelserne for "Linco-Spectin 100 og relaterede navne", veterinærlægemidler, som indeholder de aktive stoffer "Lincomycin and spectinomycin" ((2014)5053 af 11/07/2014) http://ec.europa.eu/health/documents/community-register/html/vo25233.htm
Commission Decision concerning, in the framework of Article 34 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for “Linco-Spectin 100 and its associated names”, veterinary medicinal products which contain the active substances “Lincomycin and spectinomycin” ((2014)5053 of 11/07/2014) http://ec.europa.eu/health/documents/community-register/html/vo25233.htm
Efter udfaldet af den nævnte artikel 34-indbringelsesprocedure for Linco-Spectin 100 fandt Belgien det i EU's interesse at fremme effektiv og rationel anvendelse af kombinationen lincomycinspectinomycin i orale veterinærlægemidler og derved begrænse risikoen for resistensudvikling.
Subsequent to the outcome of the aforementioned Article 34 referral procedure for Linco-Spectin 100, Belgium considered that it is in the interest of the EU to promote effective and rational use of the lincomycin-spectinomycin combination in orally administered veterinary medicinal products, and thereby limit the risk of the development of resistance.
De fuldstændige ændringer i produktinformationen for pulver til anvendelse i drikkevand er beskrevet i bilag III til CVMP's udtalelse, der kan tilgås via fanen "All documents".
The full changes made to the product information for powders for use in the drinking water are detailed in Annex III of the CVMP opinion on the 'All documents' tab.
Hvorfor blev veterinærlægemidler, der indeholder en kombination af lincomycin og spectinomycin, undersøgt?
Why were veterinary medicinal products containing a combination of lincomycin and spectinomycin reviewed?
I september 2012 indledte Belgien en indbringelsesprocedure i henhold til artikel 34 i direktiv 2001/82/EF for Linco-Spectin 100, pulver til anvendelse i drikkevand til svin og kyllinger (EMEA/V/A/088).
In September 2012 Belgium initiated a referral procedure under Article 34 of Directive 2001/82/EC for Linco-Spectin 100, powder for use in the drinking water for pigs and chickens (EMEA/V/A/088).
CVMP blev anmodet om at vurdere de tilgængelige data og gennemgå indikationerne, doseringsregimerne og tilbageholdelsestiderne for svin og fjerkræ for at sikre forbrugersikkerheden, en virkningsfuld behandling af svin, kyllinger og andet fjerkræ samt en lavere risiko for udvikling af antimikrobiel resistens over for lincomycin og spectinomycin.
The CVMP was requested to assess the available data and to review the indications, dosage regimens and withdrawal periods for pigs and poultry in order to ensure consumer safety, efficacious treatment in pigs, chickens and other poultry species, as well as a lower risk of the development of antimicrobial resistance to lincomycin and spectinomycin.
Den 5. maj 2015 indledte Belgien derfor en procedure i medfør af artikel 35 i direktiv 2001/82/EF for veterinærlægemidler, der indeholder en kombination af lincomycin og spectinomycin til oral administration til svin og/eller fjerkræ.
Therefore, on 5 May 2015, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Spørgsmål og svar vedrørende veterinærlægemidler, der indeholder en kombination af lincomycin og spectinomycin og administreres oralt til svin og/eller fjerkræ EMA/462762/2016
Questions and answers on veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry EMA/462762/2016
Den 19. maj 2016 afsluttede Det Europæiske Lægemiddelagentur (EMA) en undersøgelse af sikkerheden ved og virkningen af samt den antimikrobielle resistens over for alle veterinærlægemidler, der indeholder en kombination af lincomycin og spectinomycin og administreres oralt til svin og/eller fjerkræ.
On 19 May 2016, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of, and antimicrobial resistance to, veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Til svin og fjerkræ findes der tre orale lægemiddelformer med en kombination af lincomycin og spectinomycin - premix til foderlægemiddel, pulver til anvendelse i foder og pulver til opløsning i drikkevand.
For pigs and poultry three pharmaceutical forms for oral administration exist with a combination of lincomycin and spectinomycin - premixes for medicated feeding stuff, powders to be administered with the feed and powders for use in the drinking water.
Lincomycin er aktivt mod grampositive bakterier, visse anaerobe gramnegative bakterier og Mycoplasma spp.
Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria and Mycoplasma spp.
I forbindelse med denne artikel 35-indbringelsesprocedure har indehaverne af markedsføringstilladelse fremsendt egne data og videnskabelige referencer vedrørende virkning og restkoncentrationer.
Proprietary data and scientific references on efficacy and residue depletion were provided by the marketing authorisation holders in this Article 35 referral procedure.
Lincomycin er et antibiotikum i lincosamidgruppen og udvindes af Streptomyces lincolnensis, som er en proteinsyntesehæmmer.
Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis which inhibits protein synthesis.
Spørgsmål og svar vedrørende veterinærlægemidler, der indeholder en kombination af lincomycin og spectinomycin og administreres oralt til svin og/eller fjerkræ
Questions and answers on veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry
CVMP anbefalede, at markedsføringstilladelserne for pulver, der indeholder en kombination af lincomycin og spectinomycin til anvendelse i drikkevand, ændres, og at produktinformationen ændres tilsvarende.
The CVMP recommended that the marketing authorisations for powders containing a combination of lincomycin and spectinomycin for use in the drinking water should be varied in order to amend the product information accordingly.
CVMP anbefalede, at alle markedsføringstilladelser for premix til foderlægemiddel og pulver til anvendelse i foder, der indeholder en kombination af lincomycin og spectinomycin, trækkes tilbage i EU.
The CVMP recommended that all marketing authorisations for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin be withdrawn throughout the European Union (EU).
Agenturets Udvalg for Veterinærlægemidler (CVMP) konkluderede, at den overordnede vurdering af benefit/risk-forholdet for premix til foderlægemiddel og pulver til anvendelse i foder, der indeholder en kombination af lincomycin og spectinomycin, er negativt, da brugen af disse produkter i de anbefalede doseringsregimer medfører en høj risiko for selektering og udvikling af resistens som følge af eksponering for lave antimikrobielle niveauer over længere perioder.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin is negative, as the use of these products at the recommended dosing regimens entails a high risk of resistance selection and development due to exposure to low antimicrobial levels for prolonged periods.
CVMP konkluderede på basis af evalueringen af de i øjeblikket tilgængelige data, at det overordnede benefit/risk-forhold for premix til foderlægemiddel og pulver til anvendelse i foder, der indeholder en kombination af lincomycin og spectinomycin, er negativt, da brugen af disse produkter i de anbefalede doseringsregimer medfører en høj risiko for selektion og udvikling af resistens som følge af eksponering for lave antimikrobielle niveauer over længere perioder.
Based on the evaluation of the currently available data, the CVMP concluded that the overall benefitrisk balance for premixes for medicated feeding stuff and powders containing a combination of lincomycin and spectinomycin, to be administered with the feed, is negative, as the use of these products at the recommended dosing regimens entails a high risk of resistance selection and development due to exposure to low antimicrobial levels for prolonged periods.
CVMP anbefalede tilbagetrækning af markedsføringstilladelserne for premix til foderlægemiddel og pulver til anvendelse i foder, der indeholder en kombination af lincomycin og spectinomycin.
The CVMP recommended the withdrawal of the marketing authorisations for premixes for medicated feeding stuff and powders containing a combination of lincomycin and spectinomycin to be administered with feed.
CVMP konkluderede også, at det overordnede benefit/risk-forhold for pulver til brug i drikkevand, der indeholder en kombination af lincomycin og spectinomycin, er positivt, og anbefalede en harmonisering af indikationer, doseringsregimer og advarselssætninger vedrørende forsvarlig brug.
The CVMP also concluded that the overall benefit-risk balance for powders for use in the drinking water containing a combination of lincomycin and spectinomycin is positive and recommended harmonised indications, dosing regimens and warning sentences on prudent use.
CVMP konkluderede ydermere, at det overordnede benefit/risk-forhold for pulver til brug i drikkevand, der indeholder en kombination af lincomycin og spectinomycin, er positivt, og vedtog harmonisering af indikationer, doseringsregimer og advarselssætninger vedrørende forsvarlig brug.
The CVMP further concluded that the overall benefit-risk balance for powders for use in the drinking water containing a combination of lincomycin and spectinomycin is positive and agreed harmonised indications, dosing regimens and warning sentences on prudent use.
Det virker bakteriostatisk og er aktivt mod visse aerobe gramnegative bakterier, grampositive kokker og Mycoplasma spp.
Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis; it has bacteriostatic activity and is active against some aerobic gram-negative bacteria, gram-positive cocci and Mycoplasma spp.
• efter anmodning fra EMEA.
− At the request of the EMEA.
I meget sjældne tilfælde er der rapporteret om fatale udfald.
In very rare cases a fatal outcome has been reported.
Yderligere skal der indsendes en opdateret RMP:
In addition, an updated RMP should be submitted:
Brug ikke Avandia efter den udløbsdato, der står på pakningen.
Do not use Avandia after the expiry date shown on the pack.
Allergiske reaktioner: Disse forekommer meget sjældent hos personer, som tager Avandia.
Allergic reactions: These are very rare in people taking Avandia.
Den kliniske relevans af denne observation er endnu ikke fuldt ud belyst.
The clinical relevance of this observation has not been fully elucidated.
Rosiglitazon kan tages sammen med eller uden mad.
Rosiglitazone may be taken with or without food.
− diabetisk ketoacidose eller diabetisk præ-koma.
- diabetic ketoacidosis or diabetic pre-coma.
Overordnet var disse stigninger generelt milde til moderate og som regel var behandlingsstop ikke nødvendigt.
Overall, these increases were generally mild to moderate and usually did not require discontinuation of treatment.
Dato for seneste fornyelse af tilladelsen: 11. juli 2005.
Date of latest renewal: 11 July 2005
Efter forlængelsen af markedsføringstilladelsen vil indehaveren af markedsføringstilladelsen indsende årlige PSURs, medmindre andet er bestemt af CHMP.
Following the renewal of the Marketing Authorisation, the Marketing Authorisation Holder will submit yearly PSURs unless otherwise decided by the CHMP.
Denne dosis kan øges til 8 mg/dag efter 8 uger, hvis en bedre glykæmisk kontrol er påkrævet.
This dose can be increased to 8 mg/day after eight weeks if greater glycaemic control is required.
Hvis du er gravid, eller der er mulighed for at du kan være det, skal du fortælle det til din læge.
If you are pregnant or could be pregnant, tell your doctor.
Hvis du holder op med at tage Avandia, vil dit blodsukker ikke længere være under kontrol, og du kan blive utilpas.
If you stop taking Avandia, your blood sugar will not be controlled, and you may become unwell.
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Tag Avandia så længe som lægen anbefaler det.
Take Avandia for as long as your doctor recommends.
Det vides ikke, om amning vil kunne medføre, at barnet eksponeres for lægemidlet.
It is not known whether breastfeeding will lead to exposure of the infant to drug.
Skønt en hormonal ubalance er set i prækliniske undersøgelser (se afsnit 5.3), så er der ikke observeret signifikante uønskede effekter i forbindelse med menstruelle forstyrrelser.
Although hormonal imbalance has been seen in preclinical studies (see section 5.3), no significant undesirable effects associated with menstrual disorders have been observed.
Patienter bør være opmærksomme på risikoen for graviditet, og hvis en patient ønsker at blive gravid, eller hvis graviditet opstår, bør behandlingen seponeres (se afsnit 4.6).
Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs the treatment should be discontinued (see section 4.6).
Der bør udvises forsigtighed ved behandling af patienter over 75 år på grund af den begrænsede erfaring med behandling af disse patienter.
Caution should be exercised in patients over 75 years because of the limited experience in this patient group.
*Frekvenskategorien for baggrundshyppigheden af disse bivirkninger, som er taget fra placebo gruppe data fra kliniske undersøgelser, er ”Almindelig”.
*The frequency category for the background incidence of these events, as taken from placebo group data from clinical trials, is 'common'.
• inden for 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering)
− Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Individuelle CL/F for den pædiatriske gruppe var i samme område som individuelle data for voksne.
Individual CL/F in the paediatric population was in the same range as individual adult data.
Måske skal dosis af dine lægemidler nedsættes.
The dose of your medicines may need to be reduced.
Avandia kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Avandia can cause side effects, but not everybody gets them.
CL/F syntes at være uafhængig af alder, men øgedes med stigende vægt i den pædiatriske gruppe.
CL/F seemed to be independent of age, but increased with weight in the paediatric population.
Den endelige halveringstid for radioaktivitet var omkring 130 timer, hvilket indikerede en meget langsom elimination af metabolitter.
The terminal half-life for radioactivity was about 130 hours indicating that elimination of metabolites is very slow.
• hvis du har haft diabetisk ketoacidose (en komplikation til diabetes, der medfører hurtigt vægttab, kvalme eller opkastning).
• if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting)
Rosiglitazons distributionsvolumen er ca. 14 liter hos raske frivillige.
The volume of distribution of rosiglitazone is approximately 14 litres in healthy volunteers.
For børn mellem 10 og 17 år er der begrænsede data om rosiglitazon som monoterapi (se afsnit 5.1 og 5.2).
For children aged 10 to 17 years, there are limited data on rosiglitazone as monotherapy (see sections 5.1 and 5.2).
Rosiglitazon kan indgives en eller to gange daglig.
Rosiglitazone may be given once or twice a day.
Det aktive stof er rosiglitazon.
The active substance is rosiglitazone.
Frekvensen er defineret som: sjælden (≥ 1/10.000, < 1/1.000) og meget sjælden (< 1/10.000) herunder isolerede rapporter.
Frequencies are defined as: rare ≥1/10,000, <1/1000 and very rare <1/10,000 including isolated reports.
Der er begrænset datamateriale til rådighed i forbindelse med overdosering hos mennesker.
Limited data are available with regard to overdose in humans.
Insulin bør kun tilføjes til etableret behandling med rosiglitazon i exceptionelle tilfælde og under tæt overvågning.
Insulin should only be added to established rosiglitazone therapy in exceptional cases and under close supervision.
Avandia kan anvendes alene eller sammen med andre lægemidler til behandling af diabetes (såsom metformin eller et sulfonylurinstof).
Avandia can be used alone or in combination with other medicines to treat diabetes (such as metformin or a sulphonylurea).
Det forhøjede totale cholesterolniveau blev forbundet med en forøgelse i både LDLc og HDLc, men forholdet af total cholesterol:HDLc var uændret eller forbedret i langtidsundersøgelser.
The elevated total cholesterol levels were associated with increase in both LDLc and HDLc, but the ratio of total cholesterol:HDLc was unchanged or improved in long term studies.