natgillin/translations-raw huggingface dataset:
Virkningen af dapagliflozin, en bestanddel af dette lægemiddel, er afhængig af nyrefunktionen, og virkningen reduceres hos patienter, som har moderat nedsat nyrefunktion, og er sandsynligvis ikke til stede hos patienter med svær nedsat nyrefunktion.
The efficacy of dapagliflozin, a component of this medicinal product, is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment.Therefore, this medicinal product is not recommended for use in patients with moderate to severe renal impairment (patients with GFR < 60 mL/min) (see section 4.2).
• ubehag ved vandladning
• discomfort when passing water (urine)
Vitamin B12mangel h,§
Lactic acidosis Vitamin B
Hvis du har taget for meget Xigduo
If you take more Xigduo than you should
Nykturi Nedsat nyrefunktion
Kidney function
Svampeinfekti on
Hepatic impairment
Forstyrrelser i leverfunktionen Hepatitis
Liver function disorder
• muskelkramper
• dry mouth
Udvalget fastholdt sine øvrige betænkeligheder.
The Committee retained its other concerns.
London, den 20. november 2008 Dok.
London, 20 November 2008 Doc.
Sygdommen er sædvanligvis dødelig i voksenalderen.
It is usually fatal in adulthood.
Internationalt fællesnavn (INN): idebenon
International non-proprietary name (INN): idebenone
Det skulle have været leveret som tabletter (150 mg).
It was to be available as tablets (150 mg).
Under revurderingen af udtalelsen var den planlagte anvendelse af lægemidlet dog begrænset til børn.
However, during the re-examination of the opinion, the intended use of the medicine was restricted to children only.
Virksomheden, der ansøgte om tilladelse, er Santhera Pharmaceuticals (Deutschland) GmbH.
The company that applied for authorisation is Santhera Pharmaceuticals (Deutschland) GmbH.
Det får ingen konsekvenser at anvende idebenon til de eksisterende indikationer, for hvilke benefit/risk-forholdet forbliver uændret.
There are no consequences on the use of idebenone in its existing indications, for which the balance of benefits and risks remains unchanged.
Hvad er Sovrima?
What is Sovrima?
Frataxin spiller en rolle i opbygningen af de energiproducerende dele af cellerne.
Frataxin plays a role in building the energy-producing parts of cells.
Hvad sker der med idebenon til kognitive forstyrrelser og Alzheimers sygdom?
What is happening with idebenone for cognitive disorders and Alzheimer's disease?
Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om markedsføringstilladelse for Sovrima
Questions and answers on recommendation for the refusal of the marketing authorisation for Sovrima
Virkningen af Sovrima blev undersøgt i en hovedundersøgelse, som omfattede 48 patienter.
The effectiveness of Sovrima was studied in one main study involving 48 patients.
Virkningerne af Sovrima blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Sovrima were first tested in experimental models before being studied in humans.
Patienter med Friedreichs ataksi producerer ikke tilstrækkeligt af et protein kaldet frataxin.
Patients with Friedreich's ataxia do not have enough of a protein called frataxin.
I den indledende ansøgning var det beregnet til behandling af børn og unge samt voksne, hvis sygdom var blevet diagnosticeret inden for de seneste fem år, og til voksne med kardiomyopati (skade på hjertemuskulaturen).
In the initial application, it was intended for use in children and young adults, as well as in adults whose disease had been diagnosed within the past five years and in adults with cardiomyopathy (harm to the heart muscle).
I undersøgelsen blev virkningen af tre forskellige doser af Sovrima (5, 15 og 40 mg pr. kg legemsvægt) sammenlignet med placebo (en virkningsløs behandling) i seks måneder.
The study compared the effectiveness of three different doses of Sovrima (5, 15 and 40 mg per kilogram body weight) with that of placebo (a dummy treatment) over six months.
Det aktive stof i Sovrima, idebenon, har været på markedet i flere europæiske lande siden 1990'erne til behandling af kognitive forstyrrelser (vanskeligheder med at tænke, lære og huske) samt Alzheimers sygdom.
The active substance in Sovrima, idebenone, has been available in some countries in Europe since the 1990s for cognitive disorders (problems with thinking, learning and memory) and for Alzheimer's disease.
Efter at have drøftet begrundelserne for denne anmodning revurderede CHMP den oprindelige udtalelse og bekræftede anbefalingen af afslag på ansøgningen om markedsføringstilladelse den 20. november 2008.
After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 November 2008.
Friedreichs ataksi er en arvelig sygdom.
Friedreich's ataxia is an inherited disease.
Dette forventedes at beskytte cellerne mod skader og mindske symptomerne på Friedreichs ataksi.
This was expected to protect cells from damage and to reduce the symptoms of Friedreich's ataxia.
Den 24. juli 2008 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgning om markedsføringstilladelse for lægemidlet Sovrima 150 mg tabletter, beregnet til behandling af Friedreichs ataksi.
On 24 July 2008, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Sovrima 150 mg tablets, intended for the treatment of Friedreich's ataxia.
Det primære effektmål var ændringen i blodets indhold af et stof, der kaldes deoxyguanosin, som er en markør for celleskade forårsaget af højt reaktive iltformer.
The main measure of effectiveness was the change in the level of a substance in the blood called deoxyguanosine, which is a marker of cell damage caused by highly reactive forms of oxygen.
Sovrima er et lægemiddel, der indeholder det aktive stof idebenon.
Sovrima is a medicine that contains the active substance idebenone.
Det forventes at virke ved at øge produktionen af energi i cellerne og muligvis ved at neutralisere de højt reaktive iltformer.
It is expected to work by enhancing the production of energy within cells and possibly by neutralising the highly reactive forms of oxygen.
Det aktive stof i Sovrima, idebenon, er en antioxidant.
The active substance in Sovrima, idebenone, is an antioxidant agent.
Når der mangler frataxin, hæmmes produktionen af energi kraftigt, og der dannes højt reaktive og giftige iltformer.
When frataxin is missing, the production of energy is severely impaired and highly reactive and toxic forms of oxygen are produced.
En række af sygdommens symptomer, som gradvist forværres, er bl.a. gangbesvær, manglende evne til at koordinere bevægelserne, muskelsvaghed, taleproblemer, skade på hjertemuskulaturen samt sukkersyge.
It has a range of symptoms that gradually get worse, including difficulty walking, an inability to co-ordinate movements, muscle weakness, speech problems, damage to the heart muscle, and diabetes.
Der blev ikke observeret en væsentlig forbedring ved behandling med Sovrima i forhold til placebo, hvad angik det primære effektmål samt andre evaluerede parametre.
Sovrima did not show a significant improvement compared with placebo, with respect to the main measure of effectiveness, as well as to other evaluated parameters.
I undersøgelsen så man også på Sovrimas virkning med hensyn til styring af bevægelser, målt på en standardskala for symptomer på ataksi, dets indvirkning på de daglige aktiviteter, målt ved hjælp af et spørgeskema, og dets effekt på hjertefunktionen.
The study looked also at the effectiveness of Sovrima in controlling movements, as measured on standard scales for ataxia symptoms, at its impact on daily activities as measured using a questionnaire, and at its effect on heart function.
I november 2008 fjernede CHMP efter revurderingen sine betænkeligheder med hensyn til den mellemste dosis af Sovrima.
In November 2008, following the re-examination, the CHMP removed its concern over the intermediate dose of Sovrima.
Hvad forventedes Sovrima anvendt til?
What was Sovrima expected to be used for?
Disse højt reaktive iltformer skader hjerne-, rygmarvs- og nerveceller samt celler i hjertet og bugspytkirtlen, hvilket forårsager sygdommens symptomer.
These highly reactive forms of oxygen damage cells in the brain, the spinal cord and nerves, as well as in the heart and pancreas, causing the symptoms of the disease.
Derfor var CHMP på daværende tidspunkt af den opfattelse, at fordelene ved Sovrima til behandling af Friedreichs ataksi ikke opvejede risiciene herved.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Sovrima in the treatment of Friedreich's ataxia did not outweigh its risks.
CHMP havde også betænkelighed ved, at der ikke var nogen klar begrundelse for, at middeldosis af Sovrima tilsyneladende var mere effektiv end den høje dosis.
The CHMP also had concerns that there was no clear explanation for the fact that the intermediate dose of Sovrima seemed to be more effective than the higher dose.
CHMP bemærkede, at det ville være nyttigt med flere oplysninger om virkningerne af Sovrima med hensyn til forebyggelse af forværring af hjertesygdom hos børn.
The CHMP noted that it would be useful to have more information on the effects of Sovrima on preventing heart disease getting worse in children.
I juli 2008 fandt CHMP grund til betænkelighed ved, at effekten af Sovrima ikke var blevet påvist i den ene undersøgelse, der var gennemført.
In July 2008, the CHMP was concerned that the effectiveness of Sovrima had not been demonstrated in the single study performed.
Desuden var dokumentationen fra faglitteraturen svag, og den viste ikke nogen vedvarende klinisk effekt af Sovrima mod denne sygdom.
In addition, the supporting information from the scientific literature was weak and did not demonstrate a consistent clinical benefit of Sovrima for this disease.
Derudover fandt CHMP grund til betænkelighed ved, at de oplysninger, som virksomheden havde fremlagt, ikke viste, at Sovrima var mere effektivt til børn end til den bredere patientgruppe, som oprindeligt var foreslået.
In addition, the CHMP was concerned that the information provided by the company did not show that Sovrima was more effective in children than in the wider group of patients initially proposed.
Hvordan forventes Sovrima at virke?
How is Sovrima expected to work?
Sovrima forventedes anvendt til behandling af Friedreichs ataksi.
Sovrima was expected to be used to treat Friedreich's ataxia.
Sovrima blev udpeget som lægemiddel til sjældne sygdomme den 8. marts 2004 til behandling af Friedreichs ataksi.
Sovrima was designated as an orphan medicinal product on 8 March 2004 for Friedreich's ataxia.
Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Sovrima eller i programmer for anvendelse af Sovrima med særlig udleveringstilladelse?
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Sovrima?
Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Sovrima.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials.
Virksomheden har ligeledes informeret CHMP om, at afslaget ikke får konsekvenser for navngivne patientprogrammer eller programmer for anvendelse med særlig udleveringstilladelse med Sovrima.
The company also informed the CHMP that there are no consequences for the named patient programmes or compassionate use programmes with Sovrima.
CHMP anbefalede derfor at give afslag på ansøgningen om markedsføringstilladelse for Sovrima.
Hence, the CHMP recommended that Sovrima be refused marketing authorisation.
Hvis der ønskes beskyttelse mod rabies:
If protection against Rabies is required:
ATCvet-kode: QI07AI02.
ATC vet code: QI07AI02.
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 07/05/2014.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/05/2014.
MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/14/164/001
MARKETING AUTHORISATION NUMBER(S) EU/2/14/164/001
* Vævskulturinficerende dosis - 50 % (tissue culture infectious dose 50 %).
* Tissue culture infectious dose 50%.
** Antistof mikroagglutinationsreaktion - lytisk reaktion (antibody micro agglutination-lytic reaction).
** Antibody micro agglutination-lytic reaction.
Farmakoterapeutisk gruppe: Immunologiske midler til canidae - levende virusvacciner og inaktiverede bakterievacciner.
Pharmacotherapeutic group: Immunologicals for canidae, live viral and inactivated bacterial vaccines.
EXP {måneder/år} Efter rekonstituering, anvendes straks.
EXP {month/year} Once reconstituted, use immediately.
Dato for seneste fornyelse af markedsføringstilladelse: 08/04/2019.
Date of last renewal: 08/04/2019.
Ved behov kan hunde under 8-uger vaccineres, da sikkerheden af Versican Plus DHPPi/L4R er påvist hos hunde i 6-ugers alderen.
In case of need, dogs younger than 8 weeks can be vaccinated as safety of Versican Plus DHPPi/L4R has been demonstrated in 6 weeks old dogs.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING En dosis à 1 ml indeholder:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
I feltstudier viste 10% af seronegative hunde dog ikke serokonvertion (> 0,1 IE/ml) 3-4 uger efter en enkelt basisvaccination mod rabies.
However, in field studies 10% of sero-negative dogs did not show seroconversion (>0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies.
I tilfælde af rejser til risikoområder eller rejser uden for EU, kan dyrlægen give en ekstra rabiesvaccination efter 12 ugers alderen for at sikre, at de vaccinerede hunde har et antistoftiter på ≥ 0,5 IE/ml som generelt anses for tilstrækkelig beskyttelse, og at det opfylder testkrav for rejser (antistoftitre på ≥ 0,5 IE/ml).
In case of travelling to risk areas or outside the EU, veterinary surgeons may wish to give additional rabies vaccinations after 12 weeks of age to ensure that the vaccinated dogs have an antibody titre of ≥ 0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements ( antibody titres ≥ 0.5 IU/ml).
En enkeltdosis af Versican Plus DHPPi/L4 bør indgives hvert 3. år.
A single dose of Versican Plus DHPPi/L4 should be given every 3 years.
Solvens (inaktiveret): L. interrogans serovar Icterohaemorrhagiae
Suspension (inactivated): L. interrogans serovar Icterohaemorrhagiae
2. dosis: Versican Plus DHPPi/L4R 3-4 uger senere men ikke tidligere end 12-ugers alderen.
Second dose: Versican Plus DHPPi/L4R 3-4 weeks later but not before 12 weeks of age.
Vaccinen er beregnet til aktiv immunisering af raske hvalpe og hunde mod sygdomme forårsaget af hundesygevirus, hundeparvovirus, hundeadenovirus type 1 og 2, hundeparainfluenzavirus, Leptospira interrogans serogruppe Australis serovar Bratislava, Leptospira interrogans serogruppe Canicola servar Canicola, Leptospira kirschneri serogruppe Grippotyphosa serovar Grippotyphosa og Leptospira interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae.
The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine parvovirus, canine adenovirus type 1 and 2, canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Mindst 3 år efter basisvaccination for for hundesygevirus, hundeadenovirus type 1, hundeadenovirus type 2 og hundeparvovirus.
At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus.
Hundeparainfluenza type 2 virus, stamme CPiV-2-Bio 15 103,1 TCID50* 105,1 TCID50 Suspension (inaktiveret):
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 103.1 TCID50* 105.1 TCID50 Suspension (inactivated):
KLINISKE OPLYSNINGER 4.1 Dyrearter, som lægemidlet er beregnet til Hund
CLINICAL PARTICULARS 4.1 Target species Dogs
1. dosis: Versican Plus DHPPi/L4 fra 8-9-ugers alderen.
First dose: Versican Plus DHPPi/L4 from 8-9 weeks of age.
103,6 TCID50* 105,3 TCID50 Hundeparvovirus type 2b, stamme CPV-2b-Bio 12/B 10
103.6 TCID50* 105.3 TCID50 Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 10
Suspension: Hvidlig væske med fint bundfald.
Suspension: whitish colour with fine sediment.
Rekonstitueret vaccine: Lyserød eller gullig farve, let opalisering.
Reconstituted vaccine: pinkish or yellowish colour with slight opalescence.
Mindst 1 år efter basisvaccination for CPiV og Leptospira komponenter.
At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components.
Vaccinevirusstammen CPV-2b har ikke været testet på kødædende dyr (undtagen hunde og huskatte), som man ved, kan være modtagelige over for hundeparvovira.
The vaccine virus strain CPV-2b has not been tested in other carnivores (except dogs and domestic cats) that are known to be susceptible to canine parvoviruses and therefore vaccinated dogs should be separated from them after vaccination.
− for at forebygge kliniske symptomer og reducere infektion og udskillelse i urinen forårsaget af L. kirschneri serogruppe Grippotyphosa serovar Grippotyphosa.
− to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Basisvaccination: To doser af Versican Plus DHPPi/L4 med 3 til 4 ugers mellemrum fra 6-ugers alderen.
Primary vaccination scheme: Two doses of Versican Plus DHPPi/L4 3-4 weeks apart from 6 weeks of age.
En enkelt dosis med forligelig Versican Plus Pi/L4vaccine kan derfor anvendes årligt som påkrævet.
Annual re-vaccination is required for Parainfluenza and Leptospira components, therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.
− for at forebygge kliniske symptomer (næse- og øjenudflåd) og begrænse virusudskillelse forårsaget af hundeparainfluenzavirus
− to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,
Vaccinen leveres i hætteglas Type I. Hætteglassene med suspension er lukket med en prop af chlorbutylgummi og et aluminiumlåg.
Type I glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap.
− for at forebygge kliniske symptomer, leukopeni og virusudskillelse forårsaget af hundeparvovirus
− to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus,
6 (Bivirkninger), efter indgift af en overdosis af vaccinen.
No other adverse effects other than those mentioned under section 6 (Adverse reactions) have been observed after administration of a 10-fold overdose of the vaccine.
− for at forebygge kliniske symptomer og udskillelse i urinen og reducere infektion forårsaget af L. interrogans serogruppe Canicola serovar Canicola og L. interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae og
− to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and
Vaccinen leveres i hætteglas Type I. Hætteglassene med lyofilisat er lukket med en prop af brombutylgummi og et aluminiumlåg.
Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
INDLÆGSSEDDEL Versican Plus DHPPi/L4 lyofilisat og suspension til injektionsvæske, suspension til hund
PACKAGE LEAFLET: Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs
Indtræden af immunitet: - 3 uger efter første vaccination for CDV, CAV, CPV - 3 uger efter basisvaccination for CPiV - 4 uger efter basisvaccination for Leptospira komponenter.
− 3 weeks after the first vaccination for CDV, CAV, CPV,
VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi/L4 - lyofilisat - til hund
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 lyophilisate for dogs
VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi/L4 - suspension - til hund
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 suspension for dogs
Dinatriumphosphatdodecahydrat
Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Water for injection
VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi/L4 lyofilisat og suspension til injektionsvæske, suspension til hund
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs
"Autolog" betyder, at det stammer fra celler i patientens egen krop.
Autologous means that it is derived from the cells in the patient's own body.
Virkningerne af Oncophage blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Oncophage were first tested in experimental models before being studied in humans.
Hvad er Oncophage?
What is Oncophage?
På daværende tidspunkt var CHMP derfor af den opfattelse, at fordelene ved Oncophage ikke opvejer risiciene.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Oncophage did not outweigh its risks.
CHMP bemærkede ligeledes, at virksomheden havde fremlagt utilstrækkelig information om lægemidlets indhold og om fremstillingsprocessen.
The Commitee also noted that the company had provided insufficient information on the contents of the medicine and on the manufacturing process.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Oncophage kan ses her.
The summary of opinion of the Committee for Orphan Medicinal Products for Oncophage is available here.
Eftersom proteinerne i vitespen ligner proteinerne i kræftceller, forventedes det, at immunsystemet også ville angribe kræftcellerne og dermed forhindre tilbagevenden eller spredning af den oprindelige tumor.
Since the proteins in vitespen are similar to proteins on the cancer cells, it was expected that the immune system would also attack the cancer cells, preventing the recurrence or the spread of the original tumour.
Der var heller ikke fremlagt tilstrækkelig information til at redegøre for, hvordan Oncophage virker ved renalcellekarcinom, og til at bestemme den rette dosis af lægemidlet.
There was also not enough information to clarify the way Oncophage works in renal cell carcinoma and to determine the appropriate dose of the medicine.
Hvad forventedes Oncophage anvendt til?
What was Oncophage expected to be used for?
Det aktive stof i Oncophage, vitespen, består af proteiner ("heat shock protein/peptid-kompleks 96"), der er blevet udvundet af patientens kræftceller.
The active substance in oncophage, vitespen, is made up of proteins (‘heat shock protein-peptide complex-96') that have been extracted from the patient's cancer cells.
Det primære effektmål var, hvor længe patienterne levede, uden at kræften kom igen.
The main measure of effectiveness was how long the patients lived without the cancer coming back.
Oncophage forventedes anvendt til patienter med renalcellekarcinom (en type nyrekræft), som endnu ikke har spredt sig til andre dele af kroppen (lokaliseret).
Oncophage was expected to be used in patients with renal cell carcinoma (a type of kidney cancer) that had not yet spread to other parts of the body (localised).
Når Oncophage gives til patienten, lærer kroppens forsvarssystem (immunsystemet) at genkende proteinerne i vitespen som fremmede og udløser en immunrespons.
When Oncophage is given to the patient, the body's defence system (immune system) learns to recognize the proteins in vitespen as foreign and triggers an immune response.