FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the applicant claims there is a very fast distribution of meloxicam from the intramuscular injection site into the general circulation and subsequently a very fast elimination from tissues like liver, kidney and muscle taking into consideration the identical elimination half-life in pigs after intravenous or intramuscular administration, which justifies the claim for waiver of a bioequivalence study in pigs based on results of the residue depletion study in comparison to the Metacam 20 mg/ml product.
Danish: Ansøgeren hævder imidlertid, at meloxicam meget hurtigt fordeles fra det intramuskulære injektionssted til kredsløbet, og at der derefter sker en meget hurtig elimination fra væv såsom lever, nyrer og muskel, hvilket fremgår af, at halveringstiden i svin er den samme efter henholdsvis intravenøs og intramuskulær administration.
English: Therefore the CVMP recommends the refusal of the granting of the marketing authorisation for Melosolute 40 mg/ml solution for injection for the target species pigs.
Danish: CHMP anbefalede derfor afslag på ansøgningen om udstedelse af markedsføringstilladelse for Melosolute, injektionsvæske, opløsning, 40 mg/ml, til måldyrearten svin.
English: The applicant submitted an application for a decentralised procedure for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses.
Danish: Ansøgeren har via den decentrale procedure indgivet en ansøgning for Melosolute, injektionsvæske, opløsning, 40 mg/ml, til kvæg, svin og heste.
English: In order to address the concerns raised by the referral, the applicant presented a justification for the omission of a bioequivalence study for Melosolute 40 mg/ml solution for injection and the reference product, Metacam 20 mg/ml solution for injection.
Danish: Til imødekommelse af de betænkeligheder, der var rejst i forbindelse med indbringelsen, fremlagde ansøgeren en begrundelse for udeladelsen af en undersøgelse af bioækvivalensen af Melosolute, injektionsvæske, opløsning, 40 mg/ml, med referenceproduktet Metacam, injektionsvæske, opløsning, 20 mg/ml.
English: In the absence of such a study, the residues depletion data provide no firm evidence that allows quantification of any difference in rate and extent of absorption of meloxicam between Melosolute 40 mg/ml and Metacam 20 mg/ml, and consequently the identification of its impact on clinical safety and efficacy is not possible.
Danish: I mangel af en sådan undersøgelse giver restkoncentrationsdataene intet konkret grundlag for kvantificering af en mulig forskel mellem Melosolute, 40 mg/ml, og Metacam, 20 mg/ml, hvad angår absorptionshastighed og absorptionsgrad af meloxicam.
English: However, in a bioequivalence study, the principle is that blood concentrations are determined over a certain timeframe, critically including the absorption phase, to derive an estimate of Cmax and AUC with the knowledge that these correlate with therapeutic effect.
Danish: I en bioækvivalensundersøgelse at princippet derimod, at blodkoncentrationerne bestemmes i løbet af et bestemt tidsrum, der kritisk omfatter absorptionsfasen.
English: The applicant accepted the timing and number of sampling points required for bioequivalence and residues depletion studies are very different, according to the respective guidelines.
Danish: Disse punkter blev behandlet under et. Ansøgeren tilsluttede sig, at der er stor forskel mellem bioækvivalensundersøgelser og restkoncentrationsundersøgelser hvad angår prøvetagningstidspunkter og antal af prøvetagninger ifølge de respektive vejledninger.
English: For this generic ‘hybrid' application, the benefits are extrapolated from the safety and efficacy data for the reference product, Metacam 20 mg/ml.
Danish: Ansøgningen er en generisk “hybrid”-ansøgning, hvor fordelene dokumenteres ved ekstrapolation fra sikkerhedsdata og kliniske data for referenceproduktet Metacam, 20 mg/ml.
English: Melosolute 40 mg/ml solution for injection for cattle, pigs and horses contains meloxicam 40 mg/ml.
Danish: Melosolute, injektionsvæske, opløsning, 40 mg/ml, til kvæg, svin og heste, indeholder meloxicam, 40 mg/ml.
English: The tissue concentration levels were derived from samples taken at 4 hours and at 2, 4 and 8 days (20 mg/ml study) or 1, 3 and 5 days after the final administration (40 mg/ml study).
Danish: I 40 mg/ml undersøgelsen blev koncentrationerne målt ved 4 timer og ved 1, 3 og 5 dage efter den sidste administration.
English: • In pigs, the proposed indications are for use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation, and for adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Danish: • Til svin er de ansøgte indikationer mindskelse af symptomerne på halten og inflammation ved ikke smittefarlige sygdomme i bevægeapparatet og, kombineret med relevant antibiotikabehandling,
English: Melosolute 40 mg/ml solution for injection is administered intramuscularly in pigs, whereas in cattle and horses it is administered intravenously.
Danish: Melosolute, injektionsvæske, opløsning, 40 mg/ml, administreres intramuskulært til svin, men intravenøst til kvæg og heste.
English: The current guideline on the conduct of bioequivalence studies (EMA/CVMP/016/00-Rev.2) gives no exemption from the need to conduct in vivo bioequivalence studies for parenterally administered solutions when the strength of the active substance differs from that of the reference product and evidence suggests that this change does have the potential to influence the rate and possibly the extent of absorption;
Danish: • ansøgningen er en generisk “hybrid”-ansøgning; i mangel af andre data må principperne for bioækvivalens derfor lægges til grund for produktets forventede sikkerhed og virkning gennem ekstrapolation af de prækliniske og kliniske data fra referenceproduktet; den gældende vejledning om udførelse af bioækvivalensundersøgelsen (EMA/CVMP/016/00-Rev.2) indeholder ingen undtagelser fra kravet om in vivo-bioækvivalensundersøgelser for parenteralt administrerede opløsninger, når styrken af det aktive stof afviger fra referenceproduktets, og når dokumentationen tyder på, at denne forskel faktisk har potentiale for at påvirke absorptionshastigheden og muligvis absorptionsgraden,
English: Potential serious risks were identified during the decentralised procedure by Ireland and the United Kingdom as they considered the bioequivalence of Melosolute 40 mg/ml solution for injection with the reference product, Metacam 20 mg/ml solution for injection had not been sufficiently demonstrated for the target species pigs, and no other satisfactory data had been provided to enable extrapolation of safety and efficacy data from the reference product for this species.
Danish: De to lande fandt, at der hos måldyrearten svin ikke tilfredsstillende var påvist bioækvivalens af Melosolute, injektionsvæske, opløsning, 40 mg/ml, med referenceproduktet Metacam, injektionsvæske, opløsning, 20 mg/ml, og at der ikke var forelagt andre fyldestgørende oplysninger, der muliggør ekstrapolation fra referenceproduktet af data vedrørende sikkerheden og virkningen hos denne dyreart.
English: • The pharmaceutical similarity of Melosolute 40 mg/ml and Metacam 20 mg/ml formulations.
Danish: • De to formuleringer Melosolute, 40 mg/ml, og Metacam, 20 mg/ml svarer i farmaceutisk henseen de til hinanden.
English: While there is a theoretical risk of increased inflammation at the site of injection due to increased tonicity of the 40 mg/ml formulation compared with the lower concentration of the reference product, injection site clinical observations and gross and microscopic pathology conducted during the residues study indicated that local inflammatory responses were minimal.
Danish: Der er en teoretisk risiko for øget inflammation på injektionsstedet som følge af større toksicitet af 40 mg/ml formuleringen end af referenceproduktet med lavere koncentration.
English: Metacam 5 mg/ml formulation.
Danish: Dette var tidligere blevet godtaget af udvalget for Metacam, 5 mg/ml.
English: • the residues depletion data provided no firm evidence that allows quantification of any difference in rate and extent of absorption of meloxicam between Melosolute 40 mg/ml and Metacam 20 mg/ml, and therefore to quantify its impact on clinical safety and efficacy; the particulars concerning the target species pigs that were submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC, and consequently do not satisfy the criteria for authorisation in respect of safety and efficacy for the target species pigs.
Danish: • ansøgningens oplysninger for måldyrearten svin ikke opfylder bestemmelserne i artikel 13 i direktiv 2000/82/EF og således ikke opfylder godkendelseskriterierne hvad angår sikkerhed og virkning hos måldyrearten svin.
English: This is the standard approach that has been applied in the past for intramuscularly or subcutaneously administered injections when the concentration of the active substance is changed, and it would be possible and scientifically valid for the applicant to conduct a comparative pharmacokinetic study to compare the Melosolute 40 mg/ml formulation with the Metacam 20 mg/ml formulation.
Danish: Det ville være muligt for ansøgeren og videnskabeligt holdbart at udføre en farmakokinetisk undersøgelse til sammenligning af Melosolute, 40 mg/ml, med Metacam, 20 mg/ml.
English: Make sure it is fixed well in place.
Danish: Sørg for, at den er ordentligt fastgjort.
English: Children less than 4 years
Danish: Børn under 4 år
English: - At the request of the European Medicines Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: After first opening: 5 months
Danish: Efter første åbning: 5 måneder.
English: * Statistically significant (p-value)
Danish: * Statistisk signifikant (p-værdi)
English: Treatment of an overdose should include general supportive measures.
Danish: Behandling af en overdosis bør omfatte generelle understøttende tiltag.
English: You do not need to remove the adaptor after use.
Danish: De behøver ikke fjerne adapteren efter brug.
English: - The medicine may be taken with or without food.
Danish: - Lægemidlet kan tages med eller uden mad.
English: Percent reduction over placebo (%)
Danish: Procentvis reduktion i forhold til placebo (%)
English: However, this is not considered to be a clinically relevant difference.
Danish: Dette anses dog ikke som værende en klinisk relevant forskel.
English: Levetiracetam None
Danish: Levetiracetam Ingen
English: The dose per intake for each patient should be calculated using the following formula:
Danish: Dosen per indtagelse for hver patient skal beregnes ved brug af følgende formel:
English: The number of patients with other ethnic background was limited.
Danish: Antallet af patienter med anden etnisk baggrund var begrænsede.
English: They were usually mild to moderate in intensity.
Danish: De var normalt milde til moderate i intensitet.
English: Do not stop treatment without talking to your doctor first.
Danish: Stop ikke behandlingen uden at tale med lægen først.
English: The efficacy outcomes are summarized in Table 2.
Danish: Virkningsresultaterne er opsummeret i tabel 2.
English: Patients were required to have at least 8 POS during the baseline period.
Danish: Det var påkrævet, at patienterne havde mindst 8 POS i løbet af baseline-perioden.
English: Volumes of oral solution to be taken per administration
Danish: Mængder af oral opløsning som skal tages per administration
English: Formal interaction studies have only been performed in adults.
Danish: Formelle interaktionsstudier er kun udført hos voksne.
English: Learning and memory function were not affected.
Danish: Indlæringsevnen og hukommelsen blev ikke påvirket.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for brivaracetam.
Danish: Mekanismen bag denne risiko er ikke kendt og de tilgængelige data udelukker ikke muligheden for en forøget risiko med brivaracetam.
English: No data available
Danish: Der foreligger ingen data
English: No safety risks were observed.
Danish: Der blev ikke observeret nogen sikkerhedsrisici.
English: When converting from oral to intravenous administration or vice versa, the total daily dose and frequency of administration should be maintained.
Danish: Ved omstilling fra oral til intravenøs administration eller vice versa skal den totale daglige dosis og administrationsfrekvens bibeholdes.
English: Belgium (name and address only for outer carton, logo on carton and etiquette)
Danish: Belgien (navn og adresse kun for ydre karton, logo på karton og etikette)
English: The clinical experience in patients ≥ 65 years is limited.
Danish: Den kliniske erfaring hos patienter ≥ 65 år er begrænset.
English: If a woman decides to become pregnant, the use of brivaracetam should be carefully re-evaluated.
Danish: Hvis en kvinde beslutter sig for at blive gravid, bør anvendelsen af brivaracetam omhyggeligt revurderes.
English: If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke anvendes umiddelbart, er opbevaringstid og opbevaringsbetingelser brugerens ansvar.
English: The terminal plasma half-life (t1/2) is approximately 9 hours.
Danish: Den terminale plasmahalveringstid (t1/2) er ca. 9 timer.
English: These partial seizures can spread and extend to larger areas on both sides of the brain - this is called a ‘secondary generalisation'.
Danish: Disse partielle anfald kan sprede og udvide sig til større områder i begge sider af hjernen - dette kaldes en ”sekundær generalisering”.
English: - 1.16 milligrams sodium per millilitre.
Danish: - 1,16 milligram natrium pr. milliliter.
English: The renal clearance of these non active metabolites was decreased 10-fold.
Danish: Den renale clearance af disse ikke-aktive metabolitter var reduceret 10foldigt.
English: Although the exact role of this protein remains to be elucidated it has been shown to modulate exocytosis of neurotransmitters.
Danish: Selvom dette proteins præcise rolle endnu ikke er klarlagt, er det vist, at det modulerer eksocytose af neurotransmittere.
English: The table below only shows examples of doses to take.
Danish: Nedenstående tabel viser eksempler på doser, som skal tages.
English: The three metabolites are not pharmacologically active.
Danish: De tre metabolitter er ikke farmakologisk aktive.
English: Instructions for use for patients or carers:
Danish: Instruktion til patienter eller omsorgspersoner:
English: Patients with more than a 25 % increase in POS are shown at left as “worse”.
Danish: Patienter med en stigning i antallet af POS på mere en 25 % er vist til venstre som ”forværring”.
English: If you have any of these thoughts at any time, contact your doctor immediately.
Danish: Hvis De på noget tidspunkt får sådanne tanker, skal De kontakte lægen omgående.
English: From a microbiological point of view, the product should be used immediately after dilution.
Danish: Ud fra et mikrobiologisk synspunkt, bør lægemidlet anvendes umiddelbart efter fortynding.
English: More than 95 % of the dose, including metabolites, is excreted in the urine within 72 hours after intake.
Danish: Mere end 95 % af dosis, inklusive metabolitter, udskilles i urinen inden for 72 timer efter indtagelse.
English: Juvenile animals studies
Danish: Juvenile dyrestudier
English: Intravenous administration was associated with infusion site pain in 2.8 % of the patients.
Danish: Intravenøs administration var forbundet med smerter på infusionsstedet hos 2,8 % af patienterne.
English: - Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.
Danish: - Hold flasken på hovedet i den ene hånd og brug den anden hånd til at fylde den orale sprøjte.
English: The risk of clinically relevant CYP3A4 interactions is considered to be low.
Danish: Risikoen for klinisk relevante CYP3A4-interaktioner anses som værende lav.
English: Adverse reactions with intravenous administration generally appeared to be similar to those observed with oral administration.
Danish: Bivirkningerne ved intravenøs administration syntes generelt at svare til dem, som blev observeret ved oral administration.
English: There are limited safety data from open-label studies in children from 1 month to <4 years of age.
Danish: Der er begrænsede sikkerhedsdata fra åbne studier hos børn fra 1 måned til < 4 år.
English: The precise volume of oral solution is to be calculated according to the exact body weight of the child.
Danish: Den præcise mængde af oral opløsning skal beregnes i henhold til barnets præcise kropsvægt.
English: The median baseline seizure frequency across the 3 studies was 9 seizures per 28 days.
Danish: Median baseline-frekvensen af anfald på tværs af de 3 studier var 9 anfald pr. 28 dage.
English: How long to use Briviact for - Your doctor will decide for how many days you will be given the injections or infusion.
Danish: Hvor længe skal De bruge Briviact - Lægen vil beslutte, hvor mange dage De skal have injektionerne eller infusionerne.
English: All studies had an 8-week baseline period followed by a 12-week treatment period with no uptitration.
Danish: Alle studierne havde en 8-ugers baseline-periode efterfulgt af en 12-ugers behandlingsperiode uden optitrering.
English: In such cases, it should be used straight after dilution.
Danish: I sådanne tilfælde skal det anvendes umiddelbart efter fortynding.
English: It belongs to a group of medicines called ‘anti-epileptics'.
Danish: Det tilhører en gruppe af lægemidler, som kaldes ”antiepileptika”.
English: None (monohydroxy derivative, MHD)
Danish: Ingen (monohydroxyderivat, MHD)
English: Plasma concentrations were shown to be dose-proportional in all age groups.
Danish: Plasmakoncentrationerne blev påvist at være proportionale med dosis hos alle aldersgrupper.
English: The 100 mg/day dose was nominally significant.
Danish: 100 mg/dag dosen var nominelt signifikant.
English: - Close the bottle with the plastic screw cap (you do not need to remove the adaptor).
Danish: - Luk flasken med plasticskruelåget (det er ikke nødvendigt at fjerne adapteren).
English: How much you will be given
Danish: Hvor meget får De
English: Additional side effects in children
Danish: Yderligere bivirkninger hos børn
English: - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Partial seizures are fits that start by only affecting one side of the brain.
Danish: - Partielle anfald er kramper, som til at begynde med kun påvirker en side af hjernen.
English: * Based on physician assessment of need for seizure control.
Danish: * Baseret på lægens vurdering af behovet for kontrol af krampeanfald.
English: Convulsion, vertigo
Danish: Konvulsioner, vertigo
English: Across all studies, 81.7 % of the patients who completed randomized studies were enrolled in the long-term open-label extension studies.
Danish: På tværs af alle studier blev 81,7 % af patienterne, som gennemførte de randomiserede studier, inkluderet i længerevarende åbne forlængelsesstudier.
English: - If you drink alcohol while taking Briviact the negative effects of alcohol may be increased.
Danish: - Hvis De drikker alkohol under behandlingen med Briviact, kan de negative virkninger af alkohol øges.
English: - Then push the plunger up to remove any possible air bubbles (figure 7).
Danish: - Skub herefter stemplet op for at fjerne eventuelle luftbobler (figur 7).
English: - You have liver problems - your doctor may need to adjust your dose.
Danish: - De har leverproblemer, det kan være nødvendigt for lægen at justere dosis.
English: Seek advice immediately from your doctor if you are pregnant or are planning to become pregnant.
Danish: Kontakt omgående lægen, hvis De er gravid eller planlægger at blive gravid.
English: - Do not drive, cycle or use any tools or machines until you know how the medicine affects you.
Danish: - De må ikke føre motorkøretøj, cykle eller bruge værktøj eller maskiner, før De ved, hvordan dette lægemiddel påvirker Dem.
English: Carbamazepine - None Carbamazepine-epoxide ↑ (See below)
Danish: Carbamazepin - Ingen Carbamazepinepoxid ↑ (Se nedenfor)
English: Brivaracetam may be initiated with either intravenous or oral administration.
Danish: Brivaracetam kan initieres enten som intravenøs eller oral administration.
English: Depression, anxiety, insomnia, irritability
Danish: Depression, angst, insomni, irritabilitet
English: Not Applicable.
Danish: Ikke relevant.
English: The median tmax for tablets taken without food is 1 hour (tmax range is 0.25 to 3 h).
Danish: Median tmax for tabletter, som tages uden mad, er 1 time (tmax interval er 0,25 til 3 timer).
English: 1,558 patients received study drug of which 1,099 received brivaracetam.
Danish: 1.558 patienter fik studiemedicin og 1.099 af disse fik brivaracetam.
English: The hydroxyacid metabolite did not reveal any safety concerns in non clinical studies.
Danish: Hydroxysyre-metabolitten viste ingen sikkerhedsrisici i non-kliniske studier.
English: Pharmacokinetics is dose-proportional from 10 to at least 600 mg.
Danish: Farmakokinetikken er proportional med dosis fra 10 til mindst 600 mg.
English: No CYP3A4 induction was found in vivo (see midazolam above).
Danish: Der blev ikke set CYP3A4-induktion in vivo (se midazolam ovenfor).
English: Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Patienter bør overvåges for, om de får tegn på selvmordstanker og -adfærd, og passende behandling bør overvejes.
English: Risk related to epilepsy and antiepileptic medicinal products in general For all anti-epileptic drugs, it has been shown that in the offspring of treated women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population.
Danish: Risici forbundet med epilepsi og antiepileptiske lægemidler generelt For alle antiepileptika er det blevet påvist, at prævalensen af misdannelser hos børn af kvinder med epilepsi er to til tre gange højere end de ca. 3 % for den generelle population.
English: - sorbitol (a type of sugar).
Danish: - sorbitol (en sukkerart).
English: You may feel dizzy and sleepy.
Danish: De kan føle Dem svimmel og søvnig.
English: Your doctor may then decide to adjust your dose to find the best dose for you.
Danish: Lægen kan derefter vælge at justere dosis for at finde den bedste dosis for Dem.
English: (Only for outer carton)
Danish: (Kun for ydre karton)
English: This may avoid the brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures from occurring.
Danish: Dette kan forhindre, at plasmakoncentrationen af brivaracetam falder til under virkningsniveauet og forebygge forekomsten af gennembrudsanfald.
English: As a precautionary measure, brivaracetam should not be used during pregnancy unless clinically necessary i.e. (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Danish: Af forsigtighedshensyn bør brivaracetam ikke anvendes under graviditet, medmindre det er klinisk nødvendigt, dvs. (hvis fordelene for moderen klart opvejer den potentielle risiko for fosteret).
English: In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/or the underlying condition is responsible has not been elucidated.
Danish: Der er observeret en stigning af misdannelser ved polyterapi i den behandlede population, men det er ikke blevet belyst i hvilket omfang behandlingen og/eller den underliggende sygdom er ansvarlig.