natgillin/translations-raw huggingface dataset:
På grund af omfanget af den hepatiske optagelse, den påkrævede høje dosis (0,05 mmol/kg kropsvægt) og den lange tid inden igangsætning af forsinket fasebilleddannelse (40 minutter) anså PRAC, at fordelen ved lægemidler, som indeholder gadobensyre, i hele den autoriserede indikation, herunder leverbilleddannelsen, ikke opvejer de potentielle og identificerede risici forbundet med brugen af dette lægemiddel.
However, in view of the extent of the hepatic uptake, the high dose (0.05 mmol/kg body weight) required and the long time to the onset of delayed phase imaging (40 mins), the PRAC considered that the benefit of gadobenic acid containing products in all the authorised indication including the liver imaging does not outweigh the potential and identified risks associated to the use of this product.
Dette er en klinisk relevant fordel, da de muliggør forbedring af dynamisk fasebilleddannelse af leveren for meget vaskulariserede leverlæsioner foruden påvisning af læsioner, der kun er synlige i den forsinkede fase.
This is a clinically relevant benefit as they allow enhancement of dynamic phase liver imaging for highly vascularised hepatic lesions and also detection of lesions that are visible only in the delayed phase.
På baggrund af de berørte hjerneområder (herunder DN og GP) vil potentielle neurologiske virkninger indbefatte virkninger på finmotoriske færdigheder eller kognitiv svækkelse, især hos patienter med aktuelle neurologiske sygdomme, der kan maskere disse hændelser.
In view of the affected brain areas (including DN and GP), potential neurological effects would include effects on fine motor skills or cognitive impairment, particularly in patients with ongoing neurological disease, which may mask these events.
Med hensyn til påstanden om, at gadodiamid (Omniscan) har en unik indikation i billeddannelse af myokardieperfusion, fandt PRAC, at helkrops-MRI-indikation omfatter billeddannelse af hjertet, herunder billeddannelse af myokardieperfusion.
With regards to the claim that gadodiamide (Omniscan) has a unique indication in myocardial perfusion imaging PRAC considered that the whole body MRI indication encompasses imaging of the heart, including myocardial perfusion imaging.
Aflejring af gadolinium i hjernen
Deposition of gadolinium in the brain
Til ophævelse af suspenderingen anbefalede PRAC, at indehaverne af markedsføringstilladelserne skal tilvejebringe evidens:
For lifting the suspension, the PRAC recommended that MAHs should provide evidence:
For at suspenderingen af intravenøse lægemidler, der indeholder gadodiamid, gadopentetinsyre og gadoversetamid, kan ophæves, skal indehaveren/indehaverne af markedsføringstilladelse fremlægge dokumentation:
For the suspension of intravenous medicinal products containing gadodiamide, gadopentetic acid, and gadoversetamide to be lifted, the marketing authorisation holder(s) shall submit evidence:
Derfor opvejer fordelene ved gadoxinsyre midlets egen risiko.
Therefore the benefit of gadoxetic acid outweighs its risk.
Makrocykliske GdCA'er
Macrocyclic GdCAs
PRAC overvejede også de to lineære GdCA'er, gadoxinsyre og gadobensyre, i leverbilleddannelsesindikationen.
PRAC also considered the two linear GdCAs, gadoxetic acid and gadobenic acid in the liver imaging indication.
Akkumulering af Gd i hjernen
Accumulation of Gd in the brain
akkumulering af Gd i hjernen og plausible skadelige virkninger samt akkumulering af Gd i andet væv og den identificerede relaterede risiko samt i betragtning af, at mindre restriktive risikominimeringsforanstaltninger ikke er mulige eller ikke er tilstrækkelige til at bringe risikoen for akkumulering af gadolinium i hjernen og andet væv ned på acceptabelt niveau, anså PRAC derfor suspendering af markedsføringstilladelsen til intravenøse lineære GdCA'er er den mest hensigtsmæssige foranstaltning til at mindske de risici, der er forbundet med disse lægemidler.
Therefore, in view of the evidence regarding accumulation of Gd in brain and the plausible harmful effects, and accumulation of Gd in other tissues and the identified related risk, and considering that less restrictive risk minimisation measures are not feasible or not sufficient to bring the risk of accumulation of gadolinium in the brain and other tissues to an acceptable level, PRAC considered the suspension of the marketing authorisation of intravenous linear GdCAs is the most appropriate measure to mitigate the risks related to these products.
På baggrund af viden om funktionen af de påvirkede områder i hjernen (herunder DN og GP) vil disse virkninger omfatte effekter på finmotorik eller kognitiv svækkelse, især hos personer med aktuel neurologisk sygdom, der kan maskere syntese-events.
Based on the knowledge of the function of the affected brain areas (including DN and GP), these effects would include effects on fine motor skills or cognitive impairment, particularly in those with ongoing neurological disease which may mask these events.
I den kliniske hverdag er der praktiske vanskeligheder ved at gennemføre en effektiv begrænsning af antallet af doser, der indgives igennem en patients levetid.
There are practical difficulties in clinical daily life for implementing an effective restriction of the number of doses administered during the lifetime of a patient.
Lineære GdCA-lægemidler
Linear GdCAs products
Disse lægemidler gennemgår hepatisk optagelse og har derfor en klinisk anvendelighed til billeddannelse af dårligt vaskulariserede hepatiske læsioner, især i den forsinkede fasebilleddannelse, der ikke kan undersøges tilstrækkeligt med midler uden hepatisk optagelse, og dermed giver mulighed for tidlig diagnosticering af potentielt livstruende sygdomme.
These products undergo hepatic uptake, and have therefore a clinical utility for imaging poorly vascularised hepatic lesions, especially in the delayed phase imaging, that cannot be adequately studied with agents without hepatic uptake and thus allowing early diagnosis of potentially life threatening diseases.
• I forhold til Magnevist (gadopentetinsyre) til intra-artikulær injektion, anså CHMP, i betragtning af den lave dosis, den begrænsede potentielle re-eksponering for patienter og fraværet af evidens for hjerneakkumulering, at fordelene ved dette lægemiddel opvejer risiciene .
• In relation to the Magnevist (gadopentetic acid) for intra-articular injection, in view of the low dose, the limited potential for repeated exposure for patients and the absence of evidence of brain accumulation, CHMP considered that the benefits of this product outweigh its risks.
• I forhold til Magnevist (gadopentetinsyre) til intra-artikulær injektion, anså PRAC, i betragtning af den lave dosis, den begrænsede potentielle re-eksponering for patienter og fraværet af evidens for hjerneakkumulering, at fordelene ved dette lægemiddel opvejer risiciene .
• In relation to the Magnevist (gadopentetic acid) for intra-articular injection, in view of the low dose, the limited potential for repeated exposure for patients and the absence of evidence of brain accumulation, PRAC considered that the benefits of this product outweigh its risks.
brugen af makrocykliske midler i klinisk praksis, og den nuværende sikkerhedsbekymring, der hviler over alle GdCA'er, skyldes den kliniske anvendelse af lineære GdCA'er.
It was also mentioned that there is currently little, if any, concern amongst experts specifically about the use of macrocyclic agents in clinical practice, and the current safety concern laying over all GdCAs arises from the clinical use of linear GdCAs.
Derfor anbefaler CHMP ændringen i betingelserne for markedsføringsgodkendelser for lægemidler, der indeholder intravenøs gadobutrol, gadoterinsyre, gadoteridol, gadoxinsyre, intravenøs gadobensyre i indikationen af lever-billeddannelse, intra-artikulær gadoterinsyre og intra-artikulær gadopentetinsyre.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intraarticular gadopentetic acid.
Intra-artikulære GdCA-lægemidler
Intra-articular GdCA products
Endvidere så CHMP på erklæringen om adressering af den potentielle skade i forbindelse med gadolinium-akkumulering i hjernen: Selvom der ikke er blevet påvist negative neurologiske virkninger, som f.eks. kognitive eller bevægelsesforstyrrelser, forårsaget af gadolinium-akkumulering i hjernen, er langsigtede sikkerhedsdata begrænset.
The CHMP further considered the statement addressing the potential harm associated with the gadolinium accumulation in the brain: “although no adverse neurological effects, such as cognitive or movement disorders, have been demonstrated to be caused by gadolinium accumulation in the brain, long-term safety data are limited.
CHMP konkluderede også, at der er praktiske vanskeligheder ved at gennemføre en effektiv begrænsning af antallet af doser, der indgives igennem en patients levetid.
The CHMP also concluded that there are practical difficulties for an effective restriction of the number of doses administered during the lifetime of a patient.
• CHMP tog højde for, at de lineære intravenøse midler, Multihance (gadobensyre) og Primovist (gadoxinsyre) gennemgår hepatisk optagelse og derfor har klinisk anvendelighed til billeddannelse af dårligt vaskulariserede hepatiske læsioner, især i den forsinkede fasebilleddannelse, der ikke kan undersøges tilstrækkeligt med midler uden hepatisk optagelse, og dermed giver mulighed for tidlig diagnosticering af potentielt livstruende sygdomme.
• The CHMP took into account that the linear intravenous agents, Multihance (gadobenic acid) and Primovist (gadoxetic acid), undergo hepatic uptake, and therefore have clinical utility for imaging poorly vascularised hepatic lesions, especially in the delayed phase imaging, that cannot be adequately studied with agents without hepatic uptake and thus allowing early diagnosis of potentially life threatening diseases.
• PRAC tog højde for, at de lineære intravenøse midler, Multihance (gadobensyre) og Primovist (gadoxinsyre) gennemgår hepatisk optagelse og derfor har klinisk anvendelighed til billeddannelse af dårligt vaskulariserede hepatiske læsioner, især i den forsinkede fasebilleddannelse, der ikke kan undersøges tilstrækkeligt med midler uden hepatisk optagelse, og dermed giver mulighed for tidlig diagnosticering af potentielt livstruende sygdomme.
• The PRAC took into account that the linear intravenous agents, Multihance (gadobenic acid) and Primovist (gadoxetic acid), undergo hepatic uptake, and therefore have clinical utility for imaging poorly vascularised hepatic lesions, especially in the delayed phase imaging, that cannot be adequately studied with agents without hepatic uptake and thus allowing early diagnosis of potentially life threatening diseases.
Risk/benefit-forholdet for lægemidler, der indeholder intravenøs gadobutrol, gadoterinsyre, gadoteridol, gadoxinsyre, intravenøs gadobensyre i indikationen af lever-billeddannelse, intra-artikulær gadoterinsyre og intra-artikulær gadopentetinsyre, er fordelagtig i forbindelse med vedtagne ændringer af produktinformationen:
The benefit-risk balance of medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intra-articular gadopentetic acid is favourable subject to agreed changes to the product information:
Som følge heraf finder CHMP, at risk/benefit-forholdet for lægemidler, der indeholder intravenøs gadobutrol, gadoterinsyre, gadoteridol, gadoxinsyre, intravenøs gadobensyre i indikationen af leverbilleddannelse, intra-artikulær gadoterinsyre og intra-artikulær gadopentetinsyre fortsat er fordelagtig under forudsætning af ændringer af produktinformationen.
The CHMP, as a consequence, considers that the benefit-risk balance of medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intra-articular gadopentetic acid remains favourable subject to amendments to the product information.
PRAC konkluderede også, at der er praktiske vanskeligheder ved at gennemføre en effektiv begrænsning af antallet af doser, der indgives igennem en patients levetid.
The PRAC also concluded that there are practical difficulties for an effective restriction of the number of doses administered during the lifetime of a patient.
Derfor overvejede CHMP, at fordelene ved gadobensyre og gadoxinsyre opvejer risiciene i forbindelse med disse lægemidler i kombination med billeddannelse af leveren.
Therefore, the CHMP considered that the benefits of gadobenic acid and gadoxetic acid outweigh the risks related to these products in the context of liver imaging.
• Selvom der ikke er blevet påvist negative neurologiske virkninger, som f.eks. kognitive eller bevægelsesforstyrrelser, forårsaget af gadolinium-akkumulering i hjernen, er langsigtede sikkerhedsdata begrænset.
• Although no adverse neurological effects, such as cognitive or movement disorders, have been demonstrated to be caused by gadolinium accumulation in the brain, long-term safety data are limited.
• Selvom der endnu ikke er blevet påvist negative neurologiske virkninger, som f.eks. kognitive eller bevægelsesforstyrrelser, forårsaget af gadolinium-akkumulering i hjernen, er langsigtede sikkerhedsdata begrænset.
• Although no adverse neurological effects, such as cognitive or movement disorders, have yet been demonstrated to be caused by gadolinium accumulation in the brain, long-term safety data are limited.
• CHMP anså, at den risiko, der er forbundet med lineære intravenøse GdCA'er, gadobensyre (i alle indikationer ud over billeddannelse af leveren), gadodiamid, gadopentetinsyre og gadoversetamid under hensyntagen til hele sikkerhedsprofilen, inkl.
• The CHMP considered that the risk related to linear intravenous GdCAs gadobenic acid (in all indications besides liver imaging), gadodiamide, gadopentetic acid, and gadoversetamide, taking into account the whole safety profile, including the additional potential risk of harm from brain and other tissues accumulation outweighs the benefits.
• PRAC anså, at den risiko, der er forbundet med lineære intravenøse GdCA'er, gadobensyre (i alle indikationer ud over billeddannelse af leveren), gadodiamid, gadopentetinsyre og gadoversetamid under hensyntagen til hele sikkerhedsprofilen, inkl.
• The PRAC considered that the risk related to linear intravenous GdCAs gadobenic acid (in all indications besides liver imaging), gadodiamide, gadopentetic acid, and gadoversetamide, taking into account the whole safety profile, including the additional potential risk of harm from brain and other tissues accumulation outweighs the benefits.
Derfor overvejede PRAC, at fordelene ved gadobensyre og gadoxinsyre opvejer risiciene i forbindelse med disse lægemidler i kombination med billeddannelse af leveren.
Therefore, the PRAC considered that the benefits of gadobenic acid and gadoxetic acid outweigh the risks related to these products in the context of liver imaging.
Derfor overvejede PRAC, at fordelene ved gadobensyre og gadoxinsyre opvejer risiciene i forbindelse med forsinket fasebilleddannelse af leveren.
Therefore, PRAC considered that the benefits of gadobenic acid and gadoxetic acid outweigh their risks in the context of delayed phase liver imaging.
NSF, hudplaques) og i ikkekliniske data.
Toxicity has been seen in other tissues where it accumulates (including NSF, skin plaques) and in non-clinical data.
Under hensyntagen til evidensen for akkumulering af GdCA'er i hjernen, den kendsgerning at lineære forbindelser er blevet påvist i årevis i hjernen i meget større mængde end de makrocykliske forbindelser, og at de persisterer i hjernen i en længere periode, og i betragtning af toksiciteten af Gd vist i prækliniske forsøg, de alvorlige bekymringer om potentiel neurologisk skade, aflejring i andre væv samt de potentielle risici og de identificerede risici forbundet med anvendelsen af lineære GdCA'er (inkl.
Taking into account the evidence of accumulation of GdCAs in the brain, the fact that linear compounds have been detected in the brain to a much higher amount than the macrocyclic compounds and that they persist in the brain for a longer period, and considering the toxicity of Gd shown in non-clinical studies, the serious concerns about potential neurological harm, deposition in other tissues and its potential risks, and the identified risks associated with the use of linear GdCAs (including the risk of NSF and the gadolinium-associated plaques) and in view of the whole safety profile of these agents, PRAC maintained its conclusion that that the benefit in enhancement of MR images of intravenous linear agents does not outweigh the known and potential risks of these products.
Med hensyn til betingelsen for ophævelse af suspenderingen skal indehaveren af markedsføringstilladelsen indsende beviser for, “at lægemidlet (potentielt modificeret eller ej) ikke gennemgår væsentlig dechelatering og ikke fører til retention af gadolinium i væv inkl.
With regards to the condition for lifting the suspension the MAH shall submit evidence “that the product (potentially modified or not) does not undergo significant dechelation and does not lead to retention of gadolinium in tissues, including the brain in humans”, CHMP agreed in general with the proposal, however considered it necessary clarifying the meaning of this condition to avoid misunderstandings.
Skadelige virkninger og potentiel interaktion med sygdomsprocesser er mulige i betragtning af data, som understøtter dechelatering af lineære midler in vivo og den kendte toksicitet af uchelateret gadolinium på baggrund af ikkekliniske data.
Harmful effects and potential interaction with disease processes are possible in view of data supporting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium based on non-clinical data.
Skadelige virkninger og potentiel interaktion med sygdomsprocesser er plausible i betragtning af stabilitetsdata, som antyder dechelatering af lineære midler in vivo og den kendte toksicitet af uchelateret gadolinium.
Harmful effects and potential interaction with disease processes are plausible in view of stability data suggesting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium.
Skadelige virkninger og potentiel interaktion med sygdomsprocesser er plausible i betragtning af data, som understøtter dechelatering af lineære midler in vivo og den kendte toksicitet af uchelateret gadolinium.
Harmful effects and potential interaction with disease processes are plausible in view of data supporting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium.
De langsigtede kliniske konsekvenser af en sådan gadolinium-retention er ikke kendt p.t. Selvom der endnu ikke er blevet påvist negative neurologiske virkninger forårsaget af gadolinium-akkumulering i hjernen, er langsigtede sikkerhedsdata begrænset.
Although no adverse neurological effects have yet been demonstrated to be caused by gadolinium accumulation in the brain, long-term safety data are limited.
Dette sammendrag blev sidst ajourført i 18/09/2015.
This summary was last updated on 18/09/2015.
I meget sjældne tilfælde kan de være alvorlige eller dødelige.
In very rare cases they may be serious or fatal.
Et respons ses normalt i løbet af 3-4 dage.
A response is normally seen within three to four days.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for RevitaCAM til den 23/02/2012.
The European Commission granted a marketing authorisation valid throughout the European Union, for RevitaCAM on 23/02/2012.
Behandlingen skal seponeres efter 10 dage, hvis der ikke ses forbedring.
Treatment should be discontinued after 10 days if no improvement is seen.
Hænderne skal altid vaskes efter administration af lægemidlet.
Hands should always be washed after administrating the medicine.
Pumpens størrelse og antallet af sprays, der skal gives, bestemmes ud fra hundens vægt.
The pump size and the number of sprays to be given are determined by the dog's weight.
Behandlingen bør indledes med en enkeltdosis på 0,2 mg/kg kropsvægt på den første dag og derefter fortsættes med en vedligeholdelsesdosis på 0,1 mg/kg kropsvægt én gang dagligt.
Treatment should be started at a single dose of 0.2 mg/kg body weight on the first day, and then continued at a maintenance dose of 0.1 mg/kg body weight once a day.
Ved længerevarende behandling kan dosis nedjusteres til den laveste virkningsfulde dosis, når et respons er blevet observeret.
For longer term treatment, the dose can be decreased to the lowest effective dose once a response has been seen.
I tilfælde af eksponering ved hændeligt uheld skal hænderne straks vaskes med vand og sæbe.
If accidental exposure occurs, hands should be washed immediately with soap and water.
Andre oplysninger om RevitaCAM:
Other information about RevitaCAM:
Det er tilgængeligt i pumper af forskellig størrelse (6 ml, 11 ml og 33 ml), som leverer passende voluminer af meloxicam til hunde af forskellig vægt.
It is available in pumps of different sizes (6 ml, 11 ml and 33 ml) delivering appropriate amounts of meloxicam for dogs of different weights.
RevitaCAM må ikke anvendes til hunde under 6 uger og bør ikke anvendes til katte.
RevitaCAM must not be used in dogs less than six weeks of age and should not be used in cats.
Personer, som er overfølsomme (allergiske) over for NSAID'er, skal undgå kontakt med RevitaCAM.
People who are hypersensitive to NSAIDs should avoid contact with RevitaCAM.
Det må ikke gives til hunde, der er overfølsomme (allergiske) over for det aktive stof eller andre af indholdsstofferne.
It must not be used in dogs that are hypersensitive (allergic) to the active substance or to any of the other ingredients.
RevitaCAM anvendes til hunde til lindring af betændelse og smerter.
RevitaCAM is used in dogs to relieve inflammation and pain.
Disse bivirkninger forekommer normalt i løbet af den første behandlingsuge og forsvinder i de fleste tilfælde efter seponering af behandlingen.
These generally occur within the first week of treatment and usually disappear once treatment has stopped.
Da prostaglandinerne er de stoffer, der udløser betændelse, smerter, eksudation og feber, mindsker meloxicam disse tegn og symptomer.
As prostaglandins trigger inflammation, pain, exudation and fever, meloxicam reduces these signs and symptoms.
RevitaCAM svarer til Metacam oral opløsning, der indeholder det samme aktive stof, men gives på en anden måde, som en mundhulespray.
RevitaCAM is similar to Metacam oral solution containing the same active substance, but given in a different way, as an oromucosal spray.
RevitaCAM er et lægemiddel, der indeholder det aktive stof meloxicam.
RevitaCAM is a medicine that contains the active substance meloxicam.
Forskellige undersøgelser så på, hvordan RevitaCAM blev optaget i kroppen, og på dets virkninger i kroppen i forhold til Metacam.
Various studies looked at how RevitaCAM was absorbed and its effects in the body, in comparison with Metacam.
RevitaCAM indeholder meloxicam, som tilhører gruppen af lægemidler kaldet non-steroide antiinflammatoriske lægemidler (NSAID'er).
RevitaCAM contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Oplysningerne om udleveringsbestemmelserne for dette lægemiddel findes på pakningens etiket.
Information on the prescription status of this product may be found on the label of the carton.
Hos nogle hunde kan der observeres nysen, hosten, gylpning eller savlen straks efter administration af behandlingen.
In some dogs sneezing, coughing, gagging or drooling may be seen immediately after treatment administration.
Det kan anvendes både ved kroniske (langvarige) lidelser i bevægeapparatet og akutte (pludselige og kortvarige) lidelser som for eksempel efter en skade.
It can be used for chronic (long term) musculo-skeletal disorders and for acute (sudden and short-lived) disorders, for instance, due to injury.