natgillin/translations-raw huggingface dataset:
Forbedring af overvågningen af veterinærlægemidler
Improving veterinary pharmacovigilance
En fællesskabsdrogemonografi omfatter HMPC's videnskabelige udtalelse om et givet plantelægemiddel baseret på udvalgets vurdering af de tilgængelige videnskabelige data (almindelig anerkendt anvendelse) eller på den historiske anvendelse af produktet i Det Europæiske Fællesskab (traditionel anvendelse).
its evaluation of available scientific data (well-established use) or on the historic use of that product in the European Community (traditional use).
CHMP godkendte en række informationsbreve til læger og en række offentlige EMEA-meddelelser.
A number of ‘Dear Doctor Letters' were agreed by the CHMP, in addition to public statements.
Udvalget frigav udkast til fællesskabslisten over plantestoffer, plantepræparater og kombinationer heraf til anvendelse i traditionelle plantelægemidler vedrørende baldrianrod og hørfrø til offentlig høring.
The Committee released for public consultation draft entries to the ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products' for Valerian root and Linseed.
4.1 humanmedicinske lægemidler
4.1 Medicines for human use
Nye lægemidler til behandling af diabetes
New medicines for the treatment of diabetes
ADR'er fra tredjelande ADR'er fra EU-lande
Non-EU ADRs EU ADRs
5.4 Certifikater for lægemidler
5.4 Certificates of a medicinal product
Udkastet omfattede baldrianrod, psylliumfrø, hørfrø, ispaghulaskaller og ispaghulafrø.
The Committee released for public consultation the first draft Community herbal monographs - for Valerian root, Psyllium seed, Linseed, Ispaghula husk and Ispaghula seed.
Disse værktøjer omfatter en hurtigere vurdering, udstedelse af markedsføringstilladelser på visse betingelser og udtalelser om lægemidler, der anvendes af humanitære grunde.
These include accelerated assessment, conditional marketing authorisation, and opinions on compassionate use of medicines.
3.1 HUMANMEDICINSKE LÆGEMIDLER 3.1.1 Lægemidler til sjældne sygdomme
3.1 Medicines for human use 3.1.1 Orphan designation
EMEA'S IDÉGRUNDLAG
EMEA MISSION STATEMENT
For at fremme innovation og udvikling af nye lægemidler i små og mellemstore virksomheder og som følge af ikrafttrædelsen af den nye SMV-forordning2 om gennemførelse af bestemmelser om Kommissionens forordning (EF) nr. 2049/2005, EUT L 329 af 16.12.2005, s. 4.
Commission Regulation (EC) No 2049/2005, OJ L329, 16.12.2005, p. 4.
Cheferne for lægemiddelstyrelserne og EMEA's bestyrelse vedtog anbefalingerne fra den ad hocarbejdsgruppe, der havde til opgave at undersøge de politiske og lovgivningsmæssige aspekter af EudraVigilance.
The recommendations by the ad hoc working group to look at policy, compliance and regulatory aspects relating to EudraVigilance were adopted by the Heads of Medicines Agencies and the EMEA Management Board.
syv antibiotika, hvoraf to er beregnet til behandling af hiv og aids fire til behandling af metaboliske sygdomme, hvoraf det ene produkt byder på en ny indgiftsmåde for diabetespatienter ved at tillade dispensering af insulin via lungerne,
Public health impact of opinions in 2005 Of the medicinal products intended for the European market for which a positive opinion was adopted: 2 are for use in cancer therapy, including the treatment of lung cancer - one of the highest causes of cancer-related deaths in the EU 7 are anti-infectives, of which 2 are for the treatment of HIV and AIDS 4 are for the treatment of metabolic disorders, of which 1 offers a new route of administration for diabetes patients by allowing insulin to be delivered via the lungs 5 are for the treatment of diseases of the central nervous system and sensory organs 6 are for the diagnosis or treatment of cardiovascular or pulmonary diseases.
Anmodninger om videnskabelig rådgivning og protokolbistand
Scientific-advice and protocol-assistance requests received
incitamenter for SMV'er i EU's nye lægemiddellovgivning har agenturet oprettet et SMV-kontor, som har til opgave at imødekomme mindre virksomheders særlige behov.
With the aim of promoting innovation and the development of new medicinal products by micro, small and medium-sized enterprises, the Agency launched the ‘SME Office', dedicated to addressing the particular needs of smaller companies, following the entry into force of the new SME Regulation3
Biologiske lægemidler, der svarer til allerede godkendte lægemidler Videnskabelige udtalelser til markeder uden for EU
Scientific opinions for non-EU markets
For at tilskynde firmaerne til at anvende denne fremgangsmåde med et hoveddossier blev der i 2005 indført forskellige incitamenter, herunder gebyrfritagelser for videnskabelig rådgivning.
Incentives, including fee waivers for scientific advice, were introduced in 2005 to encourage companies to use the core-dossier approach.
Anmodninger om protokolbistand og opfølgning
Scientific-advice and follow-up requests Protocol-assistance and follow-up requests
Basisbidrag fra EU og EØS 18 430 000 EUR
Basic EU and EEA contribution
Det kan bl.a. nævnes, at firmaerne pålægges nye forpligtelser vedrørende lægemiddelovervågning, og at der indføres nye bestemmelser for fremsendelse af risikostyringsplaner.
The new legislation contains new tools to reinforce the Agency's capacity to ensure the safety of medicines, especially new pharmacovigilance obligations on companies and new provisions for submission of risk management plans.
Lægemidler, der er udpeget som lægemidler til sjældne sygdomme.
Designated orphan medicinal products.
Bød to repræsentanter for patientorganisationer, en repræsentant for lægeorganisationer og en repræsentant for dyrlægeorganisationer velkommen som medlemmer af bestyrelsen.
Welcomed two representatives of patients', one representative of doctors' and one representative of veterinarians' organisations as members of the Board Welcomed observers from Bulgaria and Romania Reappointed Thomas Lönngren as Executive Director of the EMEA Adopted strengthened rules on the handling of conflicts of interest of committee members and experts
Efter gennemførelsen af den reviderede lægemiddellovgivning blev det obligatorisk at holde agenturet underrettet vedrørende paralleldistribution.
Notification to the EMEA became mandatory following the implementation of the revised pharmaceutical legislation.
Nye lægemidler (ikke til børn)
New medicinal products (non-orphan) Orphan medicinal products Similar biological products
Anmodninger om videnskabelig rådgivning og opfølgning
Scientific advice requests received
1 en ny kombination af endoparasitter til behandling af rundorm og bændelorm hos katte
Among the 5 positive opinions were: 1 for a third-generation cephalosporin used to treat bacterial infections in pigs 1 for a novel combination endoparasiticide to treat roundworms and tapeworms in cats 3 vaccines for horses, against equine influenza and tetanus.
Der blev modtaget otte ansøgninger om udvidelse af markedsføringstilladelser.
Eight applications for extension of a marketing authorisation were received: 6 related to pharmaceuticals and 2 to immunologicals.
Udbetalinger til nationale myndigheder for indberetningstjenester 35 492 000 EUR
Payments to national authorities for rapporteur services
Infusionen skal vare omkring fire timer.
The infusion should last around 4 hours.
Den anbefalede dosis er 2 mg pr. kg legemsvægt én gang ugentligt.
The recommended dose is 2 mg per kilogram body weight, given once a week.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vimizim den 28. april 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Vimizim on 28 April 2014.
Normalt er disse bivirkninger lette eller moderate, og de optræder oftere i de første 12 uger af behandlingen.
These are usually mild or moderate and more frequent in the first 12 weeks of treatment.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vimizim.
This is a summary of the European public assessment report (EPAR) for Vimizim.
Der kan også gives et lægemiddel til at forebygge feber.
Patients may also be given a medicine to prevent fever.
Virksomheden skal derudover oprette et register til vurdering af de langsigtede fordele og risici ved Vimizim.
The company will also set up a registry to assess the long-term benefits and risks of Vimizim.
Andre oplysninger om Vimizim
Other information about Vimizim
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Vimizim overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vimizim's benefits are greater than its risks and recommended that it be approved for use in the EU.
Der er udarbejdet en risikostyringsplan for at sikre, at Vimizim anvendes så risikofrit som muligt.
A risk management plan has been developed to ensure that Vimizim is used as safely as possible.
Hvis det mangler eller kun findes i meget små mængder, bliver GAG ikke nedbrudt, men ophobes i knogler og organer.
If the enzyme is not present, or only present in very small quantities, GAGs cannot be broken down and they build up in bones and organs.
Da antallet af patienter med mukopolysakkaridose type IVA er lavt, bliver sygdommen anset for at være “sjælden”, og Vimizim blev udpeget som “lægemiddel til sjældne sygdomme” den 24. juli 2009.
Because the number of patients with MPS IVA is low, the disease is considered ‘rare', and Vimizim was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 July 2009.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vimizim?
What measures are being taken to ensure the safe and effective use of Vimizim?
Lægemidlet fås kun på recept og skal gives af en fagligt kvalificeret sundhedsperson.
The medicine can only be obtained with a prescription and should be given by an appropriately trained healthcare professional.
Før behandlingen kunne patienterne i gennemsnit gå lidt over 200 meter på seks minutter.
Before treatment, the patients could walk on average just over 200 metres in six minutes.
Hvad er Vimizim, og hvad anvendes det til?
What is Vimizim and what is it used for?
Hvorfor er Vimizim blevet godkendt?
Why is Vimizim approved?
Den fuldstændige EPAR og en sammenfatning af risikohåndteringsplanen for Vimizim 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 Vimizim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Det er ikke en praktisk vejledning i, hvordan Vimizim bør anvendes.
It is not intended to provide practical advice on how to use Vimizim.
Hvilke risici er der forbundet med Vimizim?
What are the risks associated with Vimizim?
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Vimizim findes på EMA's 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 Vimizim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
En alvorlig, men ikke almindelig reaktion på infusionen er svær allergisk reaktion (anafylaksi).
Serious but uncommon infusion-related reactions include anaphylaxis (severe allergic reaction).
Før Vimizim indgives, skal der gives et lægemiddel, der forebygger allergisk reaktion på Vimizim.
Before receiving Vimizim, the patient should be given a medicine to prevent an allergic reaction to Vimizim.
Undersøgelsen tyder desuden på, at lægemidlet kan forbedre patienternes vejrtrækning og evne til at gå op ad trapper samt deres vækst.
Study results also suggested that the medicine could improve how well patients breathe or climb stairs, and in children, how well they grew.
Hvis du ønsker yderligere oplysninger om behandling med Vimizim, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Vimizim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det aktive stof i Vimizim, elosulfase alfa, er en kopi af det naturlige menneskelige enzym N-acetylgalactosamin-6-sulfatase.
The active substance in Vimizim, elosulfase alfa, is a copy of the human enzyme N-acetylgalactosamine-6-sulfatase.
Vimizim er et lægemiddel, der indeholder det aktive stof elosulfase alfa.
Vimizim is a medicine that contains the active substance elosulfase alfa.
Tegn på sygdommen er især korte knogler, nedsat bevægelighed og vejrtrækning, sløret syn og høretab.
This causes the signs of the disease, the most noticeable being short bones, difficulty moving and breathing, clouding of the eyes and hearing loss.
Vimizim må ikke anvendes hos patienter, der har haft en livstruende allergisk reaktion på elosulfase alfa eller på andre af indholdsstofferne.
Vimizim must not be used in patients who have experienced life-threatening allergic reactions to elosulfase alfa or any of the other ingredients in Vimizim.
Efter seks måneders behandling kunne de patienter, der havde fået den anbefalede dosis af Vimizim, gå gennemsnitligt 37 m længere på seks minutter, mens de, der fik placebo, kunne gå 14 m længere.
After 6 months, patients treated with the recommended dose of Vimizim could walk an extra 37 metres on average in six minutes, compared with an increase of 14 metres in patients receiving placebo.
Behandlingen med Vimizim skal ske under opsyn af en læge, der har erfaring med mukopolysakkaridose type IVA eller tilsvarende sygdomme.
Treatment with Vimizim should be supervised by a doctor experienced in MPS IVA or similar diseases.
Virkningen blev hovedsagelig bedømt på ændringen i den distance, patienten kunne gå på seks minutter efter 6 måneders behandling.
The main measure of effectiveness was the change in the distance patients could walk in six minutes after 6 months of treatment.
I produktresuméet og indlægssedlen for Vimizim er der sikkerhedsoplysninger baseret på denne plan, bl.a. passende forholdsregler for sundhedspersonale og patienter.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vimizim, including the appropriate precautions to be followed by healthcare professionals and patients.
Den fuldstændige liste over indberettede bivirkninger med Vimizim fremgår af indlægssedlen.
For the full list of all side effects reported with Vimizim, see the package leaflet.
Alvorlige bivirkninger er ualmindelige, men der må indsamles yderligere langsigtede sikkerhedsdata.
The Committee also considered that the safety profile of Vimizim appears manageable and serious side effects are uncommon, but further long-term safety data are to be collected.
Ved behandlingen får patienten tilført det manglende enzym.
Enzyme replacement therapy provides patients with the enzyme they are lacking.
Hvis du ønsker praktisk vejledning om anvendelsen af Vimizim, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Vimizim, patients should read the package leaflet or contact their doctor or pharmacist.
Det produceres af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere enzymet.
Elosulfase alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce the enzyme.
Erstatningsenzymet nedbryder GAG og forhindrer, at de ophobes i cellerne.
The replacement enzyme helps to break down GAGs and stop them building up in cells, thereby improving the symptoms of MPS IVA.
Vimizim blev undersøgt i én hovedundersøgelse, der omfattede 176 patienter med mukopolysakkaridose type IVA.
Vimizim has been investigated in one main study involving 176 patients with MPS IVA, which compared Vimizim with placebo (a dummy treatment).
Hvilke fordele viser undersøgelserne, at der er ved Vimizim?
What benefits of Vimizim have been shown in studies?
Vimizim er enzymerstatningsbehandling.
Vimizim is an enzyme replacement therapy.
CHMP konkluderede, at det var påvist, at Vimizim var effektivt til at forbedre den afstand, patienterne kunne gå på seks minutter efter 6 måneders behandling.
The CHMP concluded that, following 6 months of treatment, Vimizim was shown to be effective at improving the distance patients could walk in six minutes, and this was accompanied by other beneficial effects, including improved ability to carry out daily activities.
Hvordan virker Vimizim?
How does Vimizim work?
Vimizim leveres som et koncentrat, der opløses og derefter indgives med drop (ved infusion) i en vene.
Vimizim is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Hvordan anvendes Vimizim?
How is Vimizim used?
Dette enzym er nødvendigt for at nedbryde stoffer af typen glycosaminoglycaner (GAG).
This disease is caused by the lack of an enzyme called N-acetylgalactosamine-6-sulfatase, which is needed to break down substances in the body called glycosaminoglycans (GAGs).
De almindeligste bivirkninger med Vimizim (som kan optræde hos mere end 1 af hver 10 behandlede) er reaktioner på infusionen.
The most common side effects with Vimizim (which may affect more than 1 in 10 people) are infusionrelated reactions, including headache, nausea (feeling sick), vomiting, fever, chills and abdominal pain (stomach ache).
Desuden skal den virksomhed, der fremstiller Vimizim, udlevere oplysningsmateriale til de læger, som kan tænkes at ville ordinere lægemidlet.
In addition, the company that makes Vimizim must ensure that all healthcare professionals expected to prescribe or use the medicine are provided with educational material, informing them of how the medicine should be used and the risk of severe allergic reactions.
Det bruges til behandling af sygdommen mukopolysakkaridose type IVA (kaldes også Morquio A-syndrom), som skyldes mangel på enzymet N-acetylgalactosamin-6-sulfatase.
It is used to treat patients with mucopolysaccharidosis type IVA (MPS IVA, also known as Morquio A syndrome).
Biotilgængeligheden blev påvist at være cirka 70%.
Bioavailability was shown to be approximately 70%.
ATCvet-kode: QP53BX03.
ATCvet code: QP53BX03.
Plasmaproteinbinding er høj (~99%).
Plasma protein binding is high (~99%).
Det anbefalede doseringsregime bør følges.
The recommended dosage regimen should be followed.
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 11/02/2011.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/02/2011.
Det anbefalede dosisregime bør følges (se punkt 4.10 for information om overdosis).
The recommended dosage regimen should be followed (see section 4.10 for information regarding overdose).
Børn må ikke komme i kontakt med veterinærlægemidlet.
Children should not come into contact with the veterinary medicinal product.
Farmakoterapeutisk gruppe: andre ektoparasiticider til systemisk brug.
Pharmacotherapeutic group: other ectoparasiticides for systemic use.
Spinosad er blevet påvist at være et substrat for P-glykoprotein (PgP).
Spinosad has been shown to be a substrate for P-glycoprotein (PgP).
Alle hunde og katte i husstanden bør behandles.
All dogs and cats within the household should be treated.
Disse virkninger er hovedsagligt forårsaget af aktivering af nikotinerge acetylkolin receptorer (nAChR'er).
These effects are caused primarily by activation of nicotinic acetylcholine receptors (nAChRs).
EU/2/10/115/017 (90 mg, 6 tabletter)
EU/2/10/115/017 (90 mg, 6 tablets)
Veterinærlægemidlet kan anvendes som del af en behandlingsstrategi i kontrollen af loppebetinget allergisk dermatitis (FAD).
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Regelmæssig månedlig behandling med Comfortis afbryder loppernes livscyklus og kan være nødvendigt for at kontrollere loppebestanden i kontaminerede husstande.
Regular monthly treatments with Comfortis break the fleas' life cycle and may be needed to control the flea population in contaminated households.
Hvis hunden eller katten ikke vil tage tabletterne direkte, kan de gives i maden eller direkte ved at åbne dyrets mund og anbringe tabletten bagerst på tungen.
If the dog or cat does not accept the tablets directly they may be administered with food, or directly by opening the animal's mouth and placing the tablet onto the back of the tongue.
Veterinærlægemidlet skal administreres med mad eller umiddelbart efter fodring.
The veterinary medicinal product should be administered with food or immediately after feeding.
SÆRLIGE OPBEVARINGSBETINGELSER Opbevar blisteren i den ydre karton.
SPECIAL STORAGE CONDITIONS Keep the blister in the outer carton.
Spørg dyrlægen om råd angående det optimale tidspunkt for start af behandling med produktet.
Seek veterinary advice regarding information on the optimal time to start treatment with this product.
Hvis der ses lopper igen i den fjerde uge, kan behandlingsintervallet afkortes med op til 3 dage hos hunde.
If fleas reappear in the fourth week, the treatment interval can be shortened by up to 3 days in dogs.
Insektbekæmpende aktivitet mod nye infestationer vedbliver i op til 4 uger.
Insecticidal activity against new infestations persists for up to 4 weeks.
Den forebyggende virkning mod nye infestationer er et resultat af aktiviteten mod voksne lopper og reduktionen i deres produktion af æg.
The preventive effect against re-infestations is a result of the activity against adult fleas and the reduction in their production of eggs.
I størstedelen af tilfælde var opkastningen forbigående, mild og krævede ikke symptomatisk behandling.
In the majority of cases, vomiting was transient, mild and did not require symptomatic treatment.
Vær forsigtig ved anvendelse til hunde og katte med præeksisterende epilepsi.
Use with caution in dogs and cats with pre-existing epilepsy.
Opbevar blisteren i den ydre karton for at beskytte mod lys.
Keep the blister in the outer carton to protect from light.
INDIKATION(ER) Til behandling og forebyggelse af loppeinfestationer.
INDICATION(S) For the treatment and prevention of flea infestations.
Behandling og forebyggelse af loppeinfestationer (Ctenocephalides felis).
Treatment and prevention of flea infestations (Ctenocephalides felis).
Cirka 90 % af spinosad består af spinosyner A og D. Af de 90 %, er forholdet af spinosyn A til A+D 0,85 når beregnet som spinosyn A/spinosyn A+D.
Approximately 90% of spinosad is comprised of spinosyns A and D. Of that 90%, the ratio of spinosyn A to A+D is 0.85 when calculated as spinosyn A/spinosyn A+D.
Effektens varighed kan reduceres, hvis dosen gives på tom mave.
The duration of efficacy may be reduced if the dose is administered on an empty stomach.
I tilfælde af tegn på kliniske bivirkninger, bør dyret behandles symptomatisk.
In case of adverse clinical signs, the animal should be treated symptomatically.
Spinosad kan derfor gensidigt påvirke andre PgP-substrater (for eksempel digoxin, doxorubicin) og muligvis forstærke bivirkninger fra sådanne molekyler eller kompromittere effekten.
Spinosad could therefore interact with other PgP-substrates (for example, digoxin, doxorubicin) and possibly enhance adverse reactions from such molecules or compromise efficacy.
I meget sjældne tilfælde blev blindhed, svækket syn og andre synsforstyrrelser observeret.
In very rare cases, blindness, impaired vision and other eye disorders were observed.
Denne aktivitet vedvarer i op til 4 uger efter en enkelt indgift af produktet.
This activity persists for up to 4 weeks after a single administration of the product.
Der kan vedblive med at være lopper i et stykke tid efter indgift af produktet pga. udklækning af voksne lopper fra loppelarver, som allerede er i omgivelserne.
Fleas may persist for a period of time after administration of the product due to the emergence of adult fleas from pupae already in the environment.