FrancophonIA/ELRC3.0 huggingface dataset:
English: HLA-A*33:03 and HLA-B*58:01 alleles have been identified as potential genetic risk factors for strontium ranelate-associated SJS/TEN in Han Chinese patients from a retrospective, case-control, pharmacogenetic study.
Danish: I et retrospektivt, farmakogenetisk case-kontrolstudie hos patienter af hankinesisk oprindelse blev HLA-A*33:03 og HLA-B*58:01 alleler identificeret som potentielle genetiske risikofaktorer for strontiumranelat-associeret SJS/TEN.
English: Serum transaminase increased (in association with hypersensitivity skin reactions)
Danish: Ikke almindelig Forhøjede aminotransferaser (i forbindelse med kutane overfølsomhedsreaktioner)
English: Venous thromboembolism
Danish: Venøse tromboemboliske komplikationer
English: No dose adjustment is required in patients with hepatic impairment(see section 5.2).
Danish: Nedsat leverfunktion Dosisjustering ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
English: Blood and lymphatic disorders Uncommon
Danish: Blod og lymfesystem
English: New vertebral fracture over the 1
Danish: Nye vertebralfrakturer i løbet det første år
English: Pyrexia (in association with hypersensitivity skin reactions) Malaise
Danish: Ikke almindelig Pyreksi (i forbindelse med dermale overfølsomhedsreaktioner)
English: Gastrointestinal disorders
Danish: Gastroøsofageal refluks
English: Lymphadenopathy (in association with hypersensitivity skin reactions)
Danish: Ikke almindelig Lymfadenopati (i forbindelse med dermale overfølsomhedsreaktioner)
English: of treatment.
Danish: Behandling
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret OSSEOR til Dem personligt.
English: Excipient
Danish: Eksema
English: Hepatobiliary disorders
Danish: Venøs tromboembolisk sygdom
English: What is valproate?
Danish: Hvad er valproat?
English: The concern was that the data presented to support this use were too limited.
Danish: Man var bekymret over, at de data, der var fremlagt til støtte for denne brug, var for begrænsede.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Danish: Neurotransmittere er kemikalier, som sætter nervecellerne i stand til at kommunikere med hinanden.
English: Medicines containing valproate have been available since the mid-1960s.
Danish: Lægemidler indeholdende valproat har kunnet fås siden midten af 1960'erne.
English: However, on 9 March 2009, the Dutch medicines regulatory agency raised an objection to this change2.
Danish: Den 9. marts 2009 gjorde den nederlandske lægemiddelmyndighed imidlertid indsigelse mod denne ændring2.
English: The CHMP noted that 25 Member States had authorised the indication in the EU.
Danish: CHMP bemærkede, at indikationen var godkendt i 25 medlemsstater i EU.
English: This change also applies to generic medicines, including Valproat Ratiopharm Chrono.
Danish: Denne ændring gælder også generiske lægemidler, herunder Valproat Ratiopharm Chrono.
English: 1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
Danish: 1 Artikel 31 i direktiv 2001/83/EF med senere ændringer, henvisning på grund af interesse for Fællesskabet.
English: 2 This objection was raised as a referral under Article 6(12) of Regulation (EC) 1084/2003 as amended, referral on a variation to a marketing authorisation.
Danish: 2 Denne indsigelse blev fremsat som en henvisning i henhold til artikel 6, stk. 12, i forordning (EF) nr. 1084/2003 med senere ændringer, henvisning om ændring af en markedsføringstilladelse.
English: However, continuation of treatment after the manic episode can be considered in patients who have responded well to valproate.
Danish: Fortsættelse af behandling efter den maniske episode kan dog overvejes hos patienter, som har responderet godt på valproat.
English: This is a mental illness causing alternating periods of high mood (mania) and depression.
Danish: Det er en mental lidelse, der forårsager skiftende perioder med højt humør (mani) og depression.
English: Overall, the data are not sufficient to support the use of valproate as a first-line treatment.
Danish: Generelt er de fremlagte data ikke tilstrækkelige til at understøtte brugen af valproat som førstevalgsbehandling.
English: On 16 April 2009, the Dutch agency also raised general concerns on the effectiveness and safety of valproic acid and valproate in this indication, noting that there were differences among Member States in the marketing authorisations for this indication.
Danish: Den 16. april 2009 gav den nederlandske myndighed ligeledes udtryk for generel bekymring med hensyn til virkningen og sikkerheden af valproinsyre og valproat ved denne indikation, idet den bemærkede, at der var forskelle mellem medlemsstaterne i markedsføringstilladelserne til denne indikation.
English: They are marketed in all European Union (EU) Member States under various trade names including Depakine/Deprakine, Depakote and Epilim, and as generic medicines.
Danish: De markedsføres i alle EU's medlemsstater under forskellige handelsbetegnelser, herunder Depakin/Deprakin, Depakot og Epilim og som generiske lægemidler.
English: The exact way valproic acid works is not fully understood, but it is known to increase the activity of the neurotransmitter gamma-amino butyric acid (GABA), by increasing the amount of GABA available in the gaps between nerve cells.
Danish: Det vides ikke helt, hvordan valproinsyre virker, men det er velkendt, at det øger aktiviteten af neurotransmitteren gamma-aminosmørsyre (GABA) ved at øge mængden af GABA i hulrummene mellem nervecellerne.
English: Because bipolar disorder occurs mainly in adult patients, the change is not applicable to liquid formulations of valproate for use in children.
Danish: Da bipolar lidelse hovedsageligt optræder hos voksne, gælder ændringen ikke flydende formuleringer af valproat til brug hos børn.
English: The Committee also concluded that the indication for the prevention of recurrence of mood episodes was not justified by the submitted data.
Danish: CHMP konkluderede ligeledes, at indikationen for forebyggelse af tilbagevenden af humørepisoder ikke var berettiget på grundlag af de fremsendte data.
English: An increase in GABA in the brain is linked to mood stabilisation, and this helps to control the manic episodes (extremely high mood) associated with bipolar disorder.
Danish: En forøgelse af GABA i hjernen medfører en stabilisering af humøret, og dette bidrager til at kontrollere de maniske episoder (meget højt humør), der er forbundet med bipolar lidelse.
English: The evidence for the use of valproate in maintenance treatment for the prevention of acute mania episode is more limited, as there is not comparison with placebo.
Danish: Evidensen for anvendelse af valproat til vedligeholdelsesbehandling til forebyggelse af akutte maniske episoder er mere begrænset, da der ikke er foretaget sammenligning med placebo.
English: Why was the use of valproate in bipolar disorder reviewed?
Danish: Hvorfor blev brugen af valproat ved bipolar lidelse vurderet?
English: 3 August and 26 October 2009
Danish: 3. august og 26. oktober 2009
English: On 15 April 2008, the company that markets Valproat Ratiopharm Chrono, a generic medicine containing valproate used as anti-epileptic, applied to the German medicines regulatory agency to extend its use to include the ‘acute treatment of manic episode and prevention of recurrence in patients with bipolar disorder'.
Danish: Den 15. april 2008 ansøgte det selskab, som markedsfører Valproat Ratiopharm Chrono, et generisk lægemiddel indeholdende valproat, der anvendes som epilepsimedicin, den tyske lægemiddelmyndighed om at udvide anvendelsen heraf til at omfatte "akut behandling af maniske episoder og forebyggelse af genfremkomst heraf hos patienter med bipolar lidelse".
English: The studies presented by the companies show some evidence that valproate is effective in the acute treatment of manic episode, as seen in placebo controlled studies of three-week duration.
Danish: De undersøgelser, som virksomhederne fremlagde, viser, at der er nogen evidens for valproats virkning ved akut behandling af maniske episoder, hvilket fremgår af placebokontrollerede undersøgelser af tre ugers varighed.
English: The review was carried out under an ‘Article 31' referral1.
Danish: Undersøgelsen fandt sted inden for rammerne af en indbringelsesprocedure i henhold til artikel 311.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of valproate-containing medicines in the management of manic episodes in bipolar disorder when lithium is contraindicated or not tolerated continue to outweigh its risks, and therefore recommended that all marketing authorisations for these medicines be varied either to include or to amend the indication.
Danish: På grundlag af evalueringen af de data, der foreligger i øjeblikket, og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved lægemidler indeholdende valproat til behandling af maniske episoder ved bipolar lidelse, når lithium er kontraindiceret eller ikke tolereres, fortsat opvejer risiciene, og anbefalede derfor, at alle markedsføringstilladelser til disse lægemidler ændres til enten at omfatte eller ændre indikationen.
English: The CHMP recommended the use of valproate for the treatment of manic episode in bipolar disorder in patients who cannot take lithium (another medicine used in bipolar disorders).
Danish: CHMP anbefalede brugen af valproat til behandling af maniske episoder ved bipolar lidelse hos patienter, som ikke kan tåle lithium (et andet lægemiddel, der anvendes ved bipolare lidelser).
English: This included published articles reporting the results of 16 clinical studies of valproate in acute mania (either on its own or in combination) and in the prevention of recurrence of mood episodes in bipolar disorder.
Danish: Disse oplysninger omfattede publicerede artikler om resultaterne af 16 kliniske undersøgelser af valproat til akut behandling af maniske episoder (enten alene eller som kombinationsbehandling) og forebyggelse af humørsvingningsepisoders tilbagevenden hos patienter med bipolar lidelse.
English: Valproate is a salt (sodium or semisodium) of valproic acid, an anti-epileptic medicine which can also be used in patients with bipolar disorder.
Danish: Valproat er et salt (natrium eller seminatrium) af valproinsyre, et lægemiddel til behandling af epilepsi, som også kan anvendes til patienter med bipolar lidelse.
English: Therefore, it asked the CHMP to carry out a full assessment of the benefit-risk balance of valproic acid and valproate in the treatment and prevention of manic episodes in bipolar disorder and to issue an opinion on whether the marketing authorisations for products containing valproate should be changed across the EU.
Danish: Den anmodede derfor CHMP om at gennemføre en fuldstændig vurdering af benefit/riskforholdet for valproinsyre og valproat ved behandling og forebyggelse af maniske episoder ved bipolar lidelse og om at afgive udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende valproat bør ændres i hele EU.
English: The Committee reviewed the information supplied by the companies that make valproate-containing medicines to support the use of valproate-containing medicine in bipolar disorders.
Danish: Udvalget vurderede oplysninger fremsendt af virksomheder, der fremstiller lægemidler indeholdende valproat, til støtte for brugen af lægemidler indeholdende valproat ved bipolare lidelser.
English: The European Medicines Agency has completed a review of the safety and effectiveness of valproate in the treatment of manic episodes in bipolar disorder.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en vurdering af sikkerheden og virkningen af valproat til behandling af maniske episoder ved bipolar lidelse.
English: This extension was in line with the reference medicine on which the
Danish: var i overensstemmelse med det referencelægemiddel, som det generiske lægemiddel er baseret på.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of valproate in this condition outweigh their risks, and that all marketing authorisations for medicines containing valproate throughout Europe should be amended to include the treatment of manic episodes in bipolar disorders when lithium is contraindicated or not tolerated.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved valproat ved denne lidelse opvejer risiciene, og at alle markedsføringstilladelser til lægemidler indeholdende valproat i Europa skal ændres, så der medtages information om behandling af maniske episoder ved bipolare lidelser, når lithium er kontraindiceret eller ikke tolereres.
English: Milk: 108 hours
Danish: Mælk: 108 timer.
English: Hence, extrapolation is not warranted.
Danish: Ekstrapolering er derfor ikke hensigtsmæssigt.
English: Meat and offal: 42 days.
Danish: Kød og indmad: 42 dage.
English: ad us. vet. Bioveta, Czech Republic)6.
Danish: ad us. vet. Bioveta, Tjekkiet)6.
English: Romvac Company SA Sos.
Danish: Rumænien Romvac Company SA Sos.
English: It is ineffective against Enterobacteriaceae.
Danish: Det er ikke effektivt mod enterobacteriaceae.
English: Applicant / Marketing authorisation holder
Danish: Ansøger/indehaver af markedsføringstilladelse
English: This approach was proposed by some of the concerned marketing authorisation holders, and it is supported by the CVMP.
Danish: Denne tilgang blev foreslået af nogle af de berørte indehavere af markedsføringstilladelse, og den støttes af CVMP.
English: Cattle,
Danish: Kvæg,
English: However, in some Member States, including the Netherlands, the reference product has not been authorised for use in sheep.
Danish: I nogle medlemsstater, herunder Nederlandene, er referenceproduktet imidlertid ikke godkendt til anvendelse hos får.
English: Information was received regarding the composition of the affected products (n=50).
Danish: Der blev fremlagt oplysninger om sammensætningen af de omhandlede produkter (n = 50).
English: As the animals in the study were treated twice daily, as opposed to once daily as usually recommended, the study design can be considered to represent a worst-case scenario.
Danish: Da dyrene i studiet blev behandlet to gange dagligt og ikke én gang dagligt som normalt anbefalet, kan studiedesignet anses for at repræsentere det værst tænkelige scenarie.
English: It is active mostly against Gram-positive bacteria and mycoplasmas.
Danish: Det er hovedsagelig aktivt mod grampositive bakterier og mycoplasmer.
English: B. For all other products listed in Annex I Summary of product characteristics
Danish: B. For alle de andre produkter, der er anført i bilag I Produktresumé
English: However, to address certain deficiencies in the data set, an additional safety factor of 30% was considered necessary resulting in a withdrawal period of 28 days.
Danish: For at imødegå en række mangler i datasættet skønnes en supplerende sikkerhedsfaktor på 30 % imidlertid nødvendig, hvorved der opnås en tilbageholdelsestid på 28 dage.
English: Nevertheless, as limiting the injection volume would require adult animals having to be injected 8 to 10 times per treatment dose, this is not considered appropriate for both practical and animal welfare considerations.
Danish: Men da en begrænsning af injektionsvolumenet vil kræve, at voksne dyr injiceres 8-10 gange pr. behandlingsdosis, vurderes dette ikke at være hensigtsmæssigt af både praktiske og dyrevelfærdsmæssige årsager.
English: However, the actual residue concentrations were not given, and the study was done using a single injection rather than repeated injections.
Danish: De faktiske restkoncentrationer fremgik dog ikke, og i studiet blev der anvendt en enkelt injektion, ikke gentagne injektioner.
English: Macrolides are categorised as critically important antimicrobials both in human and veterinary medicine, however tylosin is not used in human medicine.
Danish: Makrolider er kategoriseret som kritisk vigtige antimikrobielle stoffer i både human- og veterinærmedicin; tylosin anvendes dog ikke i humanmedicin.
English: After analysis of the residue data for the injection site using the recommended EMA statistical software (WT 1.4), it was concluded that not all the statistical requirements (i.e., F-test) were met.
Danish: Efter analyse af restkoncentrationsdataene for injektionsstedet under anvendelse, som anbefalet, af EMA's statistiske software (WT 1.4) blev det konkluderet, at ikke alle statistiske krav var opfyldt (dvs. F-test).
English: Following this approach a withdrawal period for sheep milk can be established at 108 hours.
Danish: I henhold til denne tilgang kan tilbageholdelsestiden for fåremælk fastsættes til 108 timer.
English: It is noted that this product can be used in adult sheep and that adult sheep would require treatment with higher injection volumes.
Danish: Det bemærkes, at dette produkt kan anvendes hos voksne får, og at voksne får vil kræve behandling med et større injektionsvolumen.
English: Hence, the Committee concluded that the data is considered to have a limited value for the scope of this referral procedure.
Danish: Udvalget vurderer derfor, at dataene må anses for at have begrænset værdi i forhold til denne indbringelsesprocedure.
English: However, two publically available studies were made available to CVMP.
Danish: To offentligt tilgængelige studier blev imidlertid fremlagt for CVMP.
English: This withdrawal period was considered adequate and safe for the consumer as far as the injection volume was restricted.
Danish: Tilbageholdelsestiden vurderes at være tilstrækkelig og sikker for forbrugerne, så længe injektionsvolumenet begrænses.
English: Theoretically, a withdrawal period of 42 days would accommodate for a decrease in release rate of more than 250%.
Danish: I teorien tages der ved en tilbageholdelsestid på 42 dage højde for et fald i frigivelsesrate på mere end 250 %.
English: For three of the products the concentration of tylosin is 50 mg/ml, whereas for the other 47 products it is 200 mg/ml.
Danish: For tre af produkterne er koncentrationen af tylosin 50 mg/ml, mens den for de øvrige 47 produkter er 200 mg/ml.
English: However, two publically9,10 available studies were made available to CVMP.
Danish: To offentligt tilgængelige studier9,10 blev imidlertid fremlagt for CVMP.
English: Sheep (meat) is considered a major food producing species.
Danish: Får (kød) betragtes som en meget benyttet dyreart bestemt til fødevareproduktion.
English: Consequently, the CVMP is proposing to harmonise the milk withdrawal period to products concerned to 108 hours following the approached outlined in the guideline mentioned above.
Danish: Derfor foreslår CVMP en harmonisering af tilbageholdelsestiden for mælk, hvad angår de omhandlede produkter, til 108 timer i henhold til den tilgang, der er beskrevet i ovenfor omtalte retningslinje.
English: Results from one of the studies could not be used, since data on residue concentrations at the injection site was missing.
Danish: Resultaterne fra et af studierne kunne ikke anvendes, da der manglede data om restkoncentrationer ved injektionsstedet.
English: Two days after the last dose, tylosin could no longer be detected in sheep milk.
Danish: To dage efter den sidste dosis kunne tylosin ikke længere spores i fåremælk.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration, applicants and marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsvej og ansøgere/indehavere af markedsføringstilladelse i medlemsstaterne
English: For these 49 concerned veterinary medicinal products, the overall benefit-risk balance remains positive subject to the recommended changes in the product information (see Annex III).
Danish: For disse 49 veterinærlægemidler forbliver det overordnede benefit/risk-forhold positivt, forudsat at de anbefalede ændringer indføres i produktinformationen (se bilag III).
English: In order for tylosin-derived residues to deplete below the MRLs, a sufficient time between treatment and slaughter must be allowed.
Danish: For at restkoncentrationer af tylosin kan nedbrydes til under MRL-værdierne, skal der gå tilstrækkeligt lang tid mellem behandling og slagtning.
English: Indeed, published data has shown that the rate of absorption from the injection site is inversely proportional to the viscosity of the product, i.e. the higher the viscosity, the slower the rate of absorption (Kakemi et al.,19723).
Danish: Offentliggjorte data har således vist, at absorptionshastigheden fra injektionsstedet er omvendt proportional med produktets viskositet, dvs. jo højere viskositet, desto langsommere absorption (Kakemi et al.,19723).
English: Whereas, according to current standards, residue depletion studies should be conducted in animals that are representative of the target population, it has not been possible to obtain such data within the context of this referral procedure.
Danish: I henhold til de gældende standarder skal restkoncentrationsstudier udføres hos dyr, der er repræsentative for målpopulationen, men det har ikke været muligt at fremskaffe sådanne data i forbindelse med denne indbringelsesprocedure.
English: In accordance with the current legislation and relevant guidelines, maximum residue limits withdrawal periods have to be established on the basis of species-specific residue depletion data for all major food producing species.
Danish: I henhold til gældende lovgivning og relevante retningslinjer skal maksimalgrænseværdier for restkoncentrationer og tilbageholdelsestider fastsættes ud fra dyreartsspecifikke restkoncentrationsdata for alle meget benyttede dyrearter bestemt til fødevareproduktion.
English: Within this group of 49 products, most products contain tylosin base as active substance, whereas only five products contain tylosin tartrate.
Danish: Af disse 49 produkter indeholder de fleste tylosinbase som aktivt stof, mens kun fem produkter indeholder tylosintartrat.
English: Hence, the chemical form is not considered to effect residue absorption from tissues (including the injection site).
Danish: Den kemiske form vurderes således ikke at have betydning for restkoncentrationabsorptionen fra væv (herunder injektionsstedet).
English: The results from this residue study have been used for establishing the withdrawal periods for the remaining 49 out of the 50 products concerned, i.e. for all those products considered to be comparable qualitatively regarding excipients.
Danish: Resultaterne fra dette restkoncentrationsstudie er blevet anvendt ved fastsættelse af tilbageholdelsestider for 49 ud af de 50 omhandlede produkter, dvs. for alle de produkter, der anses for at være kvalitetsmæssigt sammenlignelige, hvad angår hjælpestoffer.
English: Tylosin and its phosphate and tartrate salts are used in veterinary medicines for the treatment of conditions caused by sensitive organisms.
Danish: Tylosin og dets fosfat- og tartratsalte anvendes i veterinærlægemidler til behandling af sygdomme forårsaget af tylosinfølsomme organismer.
English: The reference product is Tylan 200 solution for injection, which has been authorised in various Member States.
Danish: Referenceproduktet er Tylan 200 injektionsvæske, opløsning, der er godkendt i en række medlemsstater.
English: Whereas these theoretical calculations are not scientifically substantiated by data, it is reasonable to assume that a withdrawal period of 42 days would ensure that consumers would not be exposed to residues of concern if the injection volume was to be restricted to 2.5 ml per injection site.
Danish: Selvom disse teoretiske beregninger ikke er videnskabeligt underbygget af data, er det rimeligt at antage, at en tilbageholdelsestid på 42 dage vil sikre, at forbrugerne ikke eksponeres for problematiske restkoncentrationer, hvis injektionsvolumenet bliver begrænset til 2,5 ml pr. injektionssted.