natgillin/translations-raw huggingface dataset:
10 år efter vaccination var henholdsvis 79%, 80%, 95%, og 40% anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved cLIA, og henholdsvis 92%, 92%, 100% og 92% var anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved IgG LIA.
Ten years after vaccination, 79%, 80%, 95% and 40% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 92%, 92%, 100%
Gardasil suspension til injektion Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet)
Gardasil suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Gardasil, injektionsvæske, suspension i fyldt injektionssprøjte:
Gardasil, suspension for injection in a pre-filled syringe :
Effekten af Gardasil imod den kombinerede forekomst af HPV 16- eller 18-relateret persisterende infektion, kondylomer, vulva- og vaginallæsioner, alle grader af CIN, AIS og cervixcancer var 84,7 % (95 % CI: 67,5, 93,7).
The efficacy of Gardasil against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 84.7% (95% CI: 67.5, 93.7).
Gardasil, injektionsvæske, suspension- fyldt sprøjte uden kanyle, pakning med 1, 10, 20
Gardasil, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20
Effekten af Gardasil imod den kombinerede forekomst af HPV 6-, 11-, 16- og 18-relateret persisterende infektion, kondylomer, vulva- og vaginallæsioner og alle grader af CIN, AIS og cervixcancere var 47,2 % (95 % CI: 33,5; 58,2).
The efficacy of Gardasil against the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 47.2% (95% CI: 33.5, 58.2).
Gardasil, injetionsvæske, suspension- fyldt sprøjte med to kanyler, pakning med 1, 10, 20
Gardasil, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Ikke kendt Cellulitis på injektionsstedet
Not known Injection-site cellulitis *
10 enkeltdoser hætteglas på 0,5 ml.
10 single dose vials, 0.5 ml each.
• effekten af Gardasil imod HPV 6-, 11-, 16-, 18-relateret CIN 1 95,9 % (95 % CI: 91,4; 98,4),
At end of study and in the combined protocols, • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9 % (95% CI: 91.4,
Mave-tarm-kanalen
Composite Endpoint
Merck Sharp & Dohme B.V.
Merck Sharp & Dohme BV Waarderweg 39
EU/1/06/357/007 - pakning med 1 stk. EU/1/06/357/008 - pakning med 10 stk. EU/1/06/357/021 - pakning med 20 stk.
EU/1/06/357/007 - pack of 1 EU/1/06/357/008 - pack of 10 EU/1/06/357/021 - pack of 20
Knogler, led, muskler og bindevæv
Musculoskeletal and Connective Tissue Disorders
Gardasil, injektionsvæske, suspension- fyldt sprøjte med én kanyle, pakning med 1, 10, 20
Gardasil, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
EU/1/06/357/003 - pakning med 1 stk. EU/1/06/357/004 - pakning med 10 stk. EU/1/06/357/019 - pakning med 20 stk.
EU/1/06/357/003 - pack of 1 EU/1/06/357/004 - pack of 10 EU/1/06/357/019 - pack of 20
Gardasil, injektionsvæske, suspension Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet)
Gardasil, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
EU/1/06/357/005 - pakning med 1 stk. EU/1/06/357/006 - pakning med 10 stk. EU/1/06/357/020 - pakning med 20 stk.
EU/1/06/357/005 - pack of 1 EU/1/06/357/006 - pack of 10 EU/1/06/357/020 - pack of 20
EU/1/06/357/001 - pakning med 1 stk. EU/1/06/357/002 - pakning med 10 stk. EU/1/06/357/018 - pakning med 20 stk.
EU/1/06/357/001 - pack of 1 EU/1/06/357/002- pack of 10 EU/1/06/357/018- pack of 20
Spørg lægen eller apotekspersonalet, hvis der er mere du vil vide.
- If you have any further questions, please ask your doctor or pharmacist.
Gardasil, injektionsvæske, suspension - hætteglas med én dosis, pakning med 1, 10, 20 stk.
Gardasil, suspension for injection - single dose vial, pack of 1, 10, 20
Gardasil, injektionsvæske, suspension i fyldt sprøjte Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet)
Gardasil, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Gardasils effekt hos kvinder i alderen fra 16 til 26 år blev vurderet i 4 placebo-kontrollerede, dobbeltblindede, randomiserede kliniske fase II og III studier.
The efficacy of Gardasil in 16- through 26 year-old women was assessed in 4 placebo-controlled, double-blind, randomised Phase II and III clinical studies including a total of 20,541 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Gardasil injektionsvæske, suspension i fyldt sprøjte Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet)
Gardasil suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Hyppighed
Posology
Gardasil injektionsvæske, suspension i fyldt sprøjte i.m.
Gardasil suspension for injection in a pre-filled syringe
Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du eller dit barn får bivirkninger, som ikke er nævnt her.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Kvalitativ og kvantitativ sammensætning
Qualitative and quantitative composition
Rationalet er som følger:
The reasoning being that:
Kød og indmad: 107 dage.
Meat and offal: 107 days.
Endelig er der taget hensyn til de anvendte analysemetoder.
Finally, consideration has been given to the analytical methods that were used.
Der blev fremlagt oplysninger om sammensætningen af de omhandlede produkter (n = 5).
Information was received regarding the composition of the affected products (n = 5).
Det sidste produkt er formuleret med en stor andel glycerolformal.
The last product is formulated with a large percentage of glycerol formal.
Der er taget hensyn til forskellene mellem de to restkoncentrationsstudier.
The differences between the two residues studies have been considered.
De to produkter, der er anvendt i studierne, indeholder næsten de samme hjælpestoffer, men i forskellige mængder.
The two products used in the studies include almost the same excipients, but in different quantities.
Der er dog nogle signifikante forskelle mellem dette produkt og de andre produktformuleringer, der er omfattet af denne indbringelsesprocedure.
However, there are some significant differences between this and the other product formulations that are in the scope of this referral procedure.
Der blev fastsat en tilbageholdelsestid på 41 dage efter statistisk evaluering af data om nedbrydning af restkoncentrationer ved brug af WT1.4-software.
A 41-day withdrawal period was determined, following statistical evaluation of the residues depletion data using the WT1.4 software.
Det centrale ikke-vandige vehikel, propylenglykol, er indeholdt i begge produkter i forskellige mængder.
The main non-aqueous vehicle, propylene glycol, is present in both products in different quantities.
Et af disse produkter (Flukiver 5%) blev anvendt i det centrale restkoncentrationsstudie, studie 1.
One of these products (‘Flukiver 5%') was used in the pivotal residues study, Study 1.
Detektionsgrænsen for muskelvæv var også lavere i studie 1 (< 2 µg/kg) end i studie 2 (492 µg/kg).
The limit of detection for muscle was also lower in Study 1 (<2 µg/kg) than in Study 2 (492 µg/kg).
For at restkoncentrationer af closantel kan nedbrydes til under MRL-værdierne, skal der gå tilstrækkeligt lang tid mellem behandling og slagtning.
In order for closantel-derived residues to deplete below the MRLs, a sufficient time between treatment and slaughter must be allowed.
En sådan risikominimerende foranstaltning blev grundigt drøftet og vurderet af CVMP og fundet unødvendig.
This mitigation measure was thoroughly evaluated and discussed by the CVMP, and determined to be unnecessary.
Dette vurderes at være en vigtig parameter, der har betydning for restkoncentrationerne ved injektionsstedet.
This is considered to be an important parameter affecting the residues at the injection site.
Referenceproduktet er Flukiver 50 mg/ml injektionsvæske, opløsning, der har været godkendt i en række medlemsstater siden 1989.
The reference product is Flukiver 50 mg/ml Solution for Injection, which has been authorised in various Member States since 1989.
Der er taget hensyn til den absolutte mængde, der injiceres ved det subkutane injektionssted.
Consideration has been given to the absolute amounts injected at the subcutaneous injection site.
Det kan ikke konkluderes ud fra de tilgængelige data, om disse raceforskelle har nogen betydning for de observerede nedbrydningsmønstre.
It cannot be concluded from the data available whether these breed differences had any influence on the depletion patterns seen.
Derfor vurderer udvalget, at den tilbageholdelsestid på 107 dage, der er anført i studie 1, kan ekstrapoleres til alle de omhandlede produkter.
Therefore, the Committee considered that the proposed WP of 107 days derived from Study 1 can be extrapolated to all concerned products.
Må ikke anvendes inden for 1 år før første læmning hos hunfår, der producerer mælk bestemt til konsum.
Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.
Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsvej og indehavere af markedsføringstilladelse i medlemsstaterne
List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration and marketing authorisation holders in the Member States
Det Forenede Kongerige vurderede derfor, at det var nødvendigt at indbringe sagen for CVMP for at beskytte forbrugersikkerheden i EU, og anmodede udvalget om at gennemgå alle data om nedbrydning af restkoncentrationer og anbefale tilbageholdelsestider for får (kød og indmad).
The UK therefore considered that it is necessary to refer the matter to the CVMP in the interests of protecting consumer safety in the Union and requested the Committee to review all available residue depletion data and recommend withdrawal periods for sheep (meat and offal).
Desuden er der anvendt forskellige racer får i de to fremlagte studier.
In addition, different breeds of sheep were used in each of the studies provided.
Det første studie omfattede merino-krydsninger, som avles med henblik på kødproduktion, mens det andet studie omfattede ripollesafår, der avles med henblik på både kød- og mælkeproduktion.
The first study used Merino crosses, which are bred for meat production, whereas the second study used Ripollesa, which are bred for both meat and milk production.
Dataene om nedbrydning af restkoncentrationer i markørvævet (levervæv) gør det ikke muligt at opnå en statistisk fastsættelse af en tilbageholdelsestid (forudsætningen om normalfordeling af fejl er ikke opfyldt).
The residue depletion data for the marker tissue, liver, do not allow for a statistical determination of a withdrawal period (the assumption of normal distribution of the errors was not met).
Et andet produkt har propylenglykol som primært vehikel og omfatter ikke vand til injektionsvæsker.
Another product has propylene glycol as the main vehicle, and includes no water for injections.
• CVMP vurderer, at det overordnede benefit/risk-forhold for de produkter, der er omfattet af denne procedure, fortsat er positivt, forudsat at der foretages ændringer i produktinformationen.
• the CVMP considered that the overall benefit-risk balance for the products under this procedure remains positive subject to amendments in the product information;
Det produkt, der blev anvendt i studie 2 ("Endoex Solucion Injectable"), har et indhold af propylenglykol, der ikke kan sammenlignes med indholdet i det produkt, der blev anvendt i studie 1.
The product used in Study 2 ‘Endoex Solucion Injectable', has a level of propylene glycol that is not comparable to the product used in Study 1.
Ved parenteral administration absorberes closantel relativt hurtigt i det systemiske kredsløb (Tmax = 824 t) og har høj bindingsgrad til albumin i plasma.
When administered parenterally, closantel is absorbed relatively quickly into the systemic circulation (Tmax = 8 - 24 h) and is highly bound to albumin in the plasma.
For at sikre forbrugersikkerheden i forhold til fødevarer, der kommer fra dyr, som er behandlet med closantel-holdige produkter, har Europa-Kommissionen fastsat MRL-værdierne for closantel i de spiselige væv hos får.
To ensure the safety of consumers of food and food products derived from animals treated with products containing closantel, the European Commission has set MRLs for closantel in the edible tissues of sheep.
Det første tidspunkt, hvor alle restkoncentrationer ligger under den tilladte MRL-værdi, er efter 89 dage, og for at tage hensyn til variabiliteten i nedbrydning hos de anvendte dyr beregnes der en tilbageholdelsestid på 107 dage under anvendelse af en sikkerhedsmargen på 20 %.
The first timepoint where all residues are below the authorised MRL is at 89 days, and, with the addition of a safety span of 20% to take into account the variability of depletion between the animals used, a withdrawal period of 107 days is calculated.
Dyreart er
Animal species
I begge studier blev der administreret en dosis på 5 mg/kg kropsvægt, men som følge af forskellen på dyrenes vægt i de to studier var de administrerede injektionsvolumener forskellige (6,7-8,4 ml i studie 1 og 3,6-5,8 ml i studie 2).
Both studies administered a dose of 5 mg/kg body weight; however, due to differences in the weights of the animals used in the two studies, the volume of product administered was different (6.7 - 8.4 ml administered in Study 1; 3.6 - 5.8 ml administered in Study 2).
To af produktformuleringerne er meget ens, idet der er tale om opløsninger, der har de samme hjælpestoffer, og hvor der anvendes den samme andel af vand og propylenglykol som vehikel.
Two of the product formulations are very similar, being solutions with similar excipients, and using a similar proportion of water and propylene glycol as the vehicle.
De omhandlede produkters virkning hos får er ikke blevet specifikt vurderet som led i denne indbringelsesprocedure, men de anses for at være effektive til behandling og forebyggelse af parasitangreb fra navngivne parasitter.
While the efficacy of the concerned products in sheep has not been specifically assessed as part of this referral, the products under assessment are considered to be effective in the treatment and prevention of infestations with named parasites.
Der blev taget udgangspunkt i resultaterne af et foreløbigt non-GLP-studie, og det var kun væv fra injektionsstedet, der blev indsamlet til analyse.
Based on the results of a preliminary non-GLP study, only the injection site tissues were collected for analysis.
Der blev fremlagt data om de fysisk-kemiske egenskaber ved de forskellige solvenser, der er anvendt i disse produktformuleringer, navnlig hvad angår deres relative viskositet og dennes indvirkning på absorptionen fra injektionsstedet.
Data were provided on the physicochemical properties of the different solvents used in these product formulations, particularly regarding their relative viscosities, and how this would affect absorption from the injection site.
• Baseret på de fremlagte data vurderes det, at studiet af den fulde nedbrydning af restkoncentrationer for Flukiver 5% (studie 1) kan betragtes som det centrale studie, da det var velrapporteret og i overensstemmelse med gældende krav.
• from the data provided, it is concluded that the full residues depletion study provided for ‘Flukiver 5%' (Study 1) could be considered as the pivotal study, as it was well-reported, and conformed well to current requirements.
Studiet blev udført i 2016 med 20 behandlede dyr (5 grupper a 4 dyr (begge køn)) og en kontrolgruppe bestående af 2 ubehandlede dyr.
The study was conducted in 2016 with 20 treated animals (five mixed-sex groups of four animals) and a control group consisting of two untreated animals.
Den anbefalede dosis er 2,5 mg eller 5 mg closantel pr. kg kropsvægt for kvæg og får, alt efter parasittens art og/eller livsstadie på behandlingstidspunktet.
The recommended doses are 2.5 mg or 5 mg closantel per kg body weight (bw) for cattle and sheep, depending on the parasitic species and/or parasitic life stage at the time of treatment.
Tilbageholdelsestiden for fårekød, hvad angår det generiske produkt Santiola, var fastsat til 77 dage, på linje med det irske referenceprodukt (selvom målarten "får" var fjernet fra referenceproduktet under ansøgningsproceduren for Santiola).
The proposed sheep meat withdrawal period for the generic product, Santiola, was 77 days, in line with the Irish reference product (although the target species ‘sheep' was removed from the reference product during the application procedure for Santiola), but not in accordance with the data provided by France during the procedure.
Closantel er et salicylanilid-ormemiddel, et syntetisk parasitbekæmpende stof, der virker mod leverikter, hæmatofage nematoder og larvestadier af visse leddyr hos får og kvæg.
Closantel is a salicylanilide anthelmintic, a synthetic antiparasitic agent with efficacy against liver fluke, haematophagous nematodes and larval stages of some arthropods in sheep and cattle.
Der blev indsendt en ansøgning i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF, dvs. en generisk ansøgning om markedsføringstilladelse efter den decentrale procedure med Irland som referencemedlemsstat for veterinærlægemidlet Santiola, som indeholder 50 mg closantel pr. ml (IE/V/0377/001/DC).
An application was submitted under Article 13(1) of Directive 2001/82/EC, i.e., a generic application for a marketing authorisation under the decentralised procedure for the veterinary medicinal product Santiola, containing 50 mg closantel per ml, with Ireland as Reference Member State (IE/V/0377/001/DC).
Når man ser på de relative andele af disse hjælpestoffer, er der ingen grund til at forvente, at viskositeten i det produkt, der indeholder glycerolformal, vil være større end viskositeten i en række af de andre produkter, der er omfattet af indbringelsesproceduren.
Considering the relative proportions of these excipients, there was no reason to expect the viscosity of the product containing glycerol formal would be greater than that of some of the other products included in this referral.
Studiet blev udført i 2009 med 30 behandlede dyr (5 grupper a 6 dyr (begge køn)) og en kontrolgruppe bestående af 1 ubehandlet dyr.
The study was conducted in 2009, with 30 treated animals (5 mixed-sex groups of six animals) and a control group consisting of one untreated animal.
Risikostyring og risikominimerende foranstaltninger
Risk management or mitigation measures
CVMP drøftede en yderligere risikominimerende foranstaltning til begrænsning af det maksimale injektionsvolumen, men vurderede, at det ikke er nødvendigt for at sikre forbrugersikkerheden.
An additional risk mitigation measure of restricting the maximum injection volumes was considered by the CVMP, but ultimately it was decided that this was not required to ensure consumer safety.
Desuden vurderes dataene fra studie 2 ikke at være egnede til fastsættelse af tilbageholdelsestider (heller ikke for det produkt, der blev anvendt i dette studie), da nedbrydningen af restkoncentrationer blev undersøgt for injektionsstedet alene.
In addition, the data provided by Study 2 was not considered to be suitable to set withdrawal periods, even for the product used in that study, since residues depletion was investigated at the injection site only.
Studie 2 undersøgte injektionsstedet alene, og dataene fra dette studie kan ikke sammenlignes eller kombineres med dataene fra studie 1 på grund af forskelle i gennemførelsen af studierne.
Study 2 investigated injection sites only, and the data from this study cannot be compared with, or combined with, the data from Study 1 due to differences in the conduct of the studies.
To af de berørte indehavere af markedsføringstilladelse fremlagde data om nedbrydning af restkoncentrationer.
Residues depletion data were submitted by two of the affected marketing authorisation holders.
Overordnet set vurderes benefit/risk-forholdet for de omhandlede veterinærlægemidler at være positivt, under forudsætning af, at de anbefalede ændringer indføres i produktinformationen (se bilag III).
The overall benefit-risk balance for the concerned veterinary medicinal products remains positive subject to the recommended changes in the product information (see Annex III).
Restkoncentrationerne af closantel efter administration lå under MRL-værdierne (maksimalgrænseværdierne for restkoncentrationer) efter henholdsvis 19 dage for nyrer, 40 dage for muskler og fedtvæv og 89 dage for lever.
The concentrations of closantel residues were below the respective maximum residue limits (MRLs) at 19 days after administration in kidney, 40 days in muscle and fat, and 89 days in liver.
Hunfårene producerede ikke mælk under forsøgets gennemførelse.
The female sheep were not lactating during the conduct of the study.
Denne indbringelsesprocedure omfatter ikke kvalitet, sikkerhed for målarten, brugersikkerhed, miljørisiko eller parasitresistens over for de omhandlede veterinærlægemidler.
Quality, target animal safety, user safety, environmental risk and parasitic resistance for the concerned veterinary medicinal products have not been assessed in this referral procedure.
Det vurderes dog ikke, at udførelsen af de to studier var tilstrækkeligt ensartet til at muliggøre en sådan sammenligning med henblik på at vurdere, om formuleringen kan have betydning for nedbrydningen ved injektionsstedet.
However, it is not considered that the conduct of the two studies was sufficiently similar to allow this comparison, and therefore to conclude on the impact that formulation may have had on injection site depletion.
CVMP drøftede, om det ville være nødvendigt at begrænse injektionsvolumenet for at imødegå en eventuel usikkerhed om betydningen af formuleringsforskelle, hvad angår injektionsstedet.
The CVMP considered whether it would be necessary to restrict the volume of injection, to mitigate any uncertainties around the effect of formulation differences at the injection sites.
Efter at have gennemgået begrundelserne for indbringelsen og de foreliggende data vurderer CVMP, at tilbageholdelsestiderne for kød og indmad fra behandlede får bør ændres til 107 dage for at sikre forbrugersikkerheden.
Having considered the grounds for referral and the data available, the CVMP concluded that the withdrawal periods for meat and offal derived from treated sheep should be amended to 107 days to provide assurance for consumer safety.
Det vurderes således, at absorptionshastigheden fra injektionsstedet, der måles i timer/dage, vil have minimal betydning for eliminationshastigheden fra de spiselige væv, der måles i uger.
Thus, it is considered that the rate of absorption from the injection site, which is measured in hours/days, will have a negligible influence on the rate of elimination from the edible tissues, which is measured in weeks.
• Der er fremlagt data, som viser, at formuleringens indvirkning på absorptionshastigheden fra injektionsstedet er af mindre betydning i betragtning af den meget langsomme eliminationshastighed fra de andre spiselige væv, og derfor kan den tilbageholdelsestid på 107 dage, der er anført i studie 1, ekstrapoleres til alle de omhandlede produkter.
• as data have been provided that demonstrate that the impact of the formulation on the rate of absorption from the injection site is of minor significance compared to the very slow rate of elimination from the other edible tissues, the withdrawal period of 107 days derived in Study 1 can be extrapolated to all concerned products.
Det er også påvist, at jo større injektionsvolumenet er, desto langsommere er absorptionshastigheden fra injektionsstedet generelt.
It was also shown that, in general, the higher the volume of injection, the slower the rate of absorption from the injection site.