natgillin/translations-raw huggingface dataset:
Under proceduren opstod der uenighed mellem referencemedlemsstaten og den berørte medlemsstat om relevansen af at påvise systemisk bioækvivalens for et lokalt anvendt og lokalt virkende lægemiddel samt yderligere betænkeligheder med hensyn til tilstrækkeligheden af den foreslåede tilbageholdelsestid.
During the procedure, there was disagreement between the Reference Member State and Concerned Member State on the applicability of demonstrating systemic bioequivalence for a locally-applied, locally-acting product, as well as an additional concern on the adequacy of the proposed withdrawal period.
Diegivende kvæg
Lactating cattle
Intramammær indgivelse til diegivende kvæg i en dosis på 3 sprøjter pr. berørt område, indgivet enkeltvis med 12 timers mellemrum
Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals
Et yderligere spørgsmål, som CVMP gennemgik, var en ændring i formuleringen af Combimox under udviklingen for at øge lægemidlets stabilitet, hvilket blev identificeret som havende en potentiel indflydelse på de aktive stoffers frigivelse fra lægemidlet og ind i vævet.
An additional issue reviewed by the CVMP was a change in the formulation of Combimox during development to increase the stability of the product, which was identified as potentially affecting the release of the active substances from the product into the tissue.
Der blev foretaget tre komparative farmakokinetiske undersøgelser med Combimox og referencelægemidlet, alle med et toperiodes overkrydsningsdesign.
Three comparative pharmacokinetic studies were carried out with Combimox and the reference product, all with a two-period cross-over design.
Det blev konkluderet, at selv om det var påvist, at Combimox er identisk med referencelægemidlet, når det gælder formulering, partikelstørrelse og viskositet, kunne dette kun betragtes som underbyggende i dette tilfælde og ikke erstatte kliniske undersøgelser for at dokumentere virkningen.
It was concluded that, although Combimox was shown to be similar to the reference product with respect to formulation, particle size and viscosity, this could only be seen as supportive in this case and could not substitute clinical studies to demonstrate efficacy.
Combimox er beregnet til behandling af mastitis hos diegivende kvæg, som er forårsaget af de væsentligste patogener, der almindeligvis forekommer i kvægs yver (Staphylococci, Streptococci og Escherichia coli).
Combimox is intended for the treatment of mastitis in lactating cows caused by the major pathogens commonly occurring from the bovine udder (Staphylococci, Streptococci and Escherichia coli).
Der skal fremlægges tilstrækkelige kliniske data for at dokumentere virkningen af Combimox Lactating Cow Intramammary Suspension.
Appropriate clinical data should be provided to confirm the efficacy of Combimox Lactating Cow Intramammary Suspension.
Resultaterne af mælkeundersøgelserne viste, at koncentrationerne af de aktive stoffer svarede til koncentrationerne i referencelægemidlet efter intramammær infusion of Combimox, selv om der var betydelig variabilitet mellem områderne og mellem dyrene for hvert af de målte farmakokinetiske parametre.
The results of the milk studies demonstrated that the concentrations of the active substances were similar to those of the reference product following the intramammary infusion of Combimox, although it was noted that there was considerable inter-quarter and inter-animal variability in each of the pharmacokinetic parameters measured.
Combimox Lactating Cow Intramammary Suspension (herefter kaldet Combimox) er en intramammær suspension, der indeholder amoxicillin (som amoxicillintrihydrat), clavulansyre (som kaliumclavulanat) og prednisolon.
Combimox Lactating Cow Intramammary Suspension (hereinafter referred to as Combimox) is an intramammary suspension containing amoxicillin (as amoxicillin trihydrate), clavulanic acid (as potassium clavulanate) and prednisolone.
Ved tilrettelæggelsen af den tilgang, der skulle anvendes til at undersøge, om Combimox havde samme virkning, havde ansøgeren ikke foretaget komparative kliniske undersøgelser, eftersom det forventedes, at de kliniske undersøgelser ikke ville være følsomme nok til at spore forskellene mellem Combimox og referencelægemidlet.
When preparing the approach used to investigate similarity in terms of efficacy for Combimox, the applicant had not pursued conducting comparative clinical studies since it was expected that clinical trials would not be sensitive enough to pick up differences between Combimox and the reference product.
Da ansøgeren blev bedt om at underbygge denne påstand yderligere, fremlagde ansøgeren komparative data om lægemidlets fysisk-kemiske karakteristika, herunder viskositet, partikelstørrelse og opløsning i mælk, for så vidt angår Combimox og referencelægemidlet.
When asked to further substantiate this claim, the applicant provided comparative data on the physico-chemical characteristics of the product, including viscosity, particle size and dissolution in milk, between Combimox and the reference product.
Begrundelser for afslag på ansøgningen om markedsføringstilladelse og suspendering af den eksisterende markedsføringstilladelse
Grounds for refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisation
Samlet resumé af den videnskabelige vurdering af Combimox Lactating Cow Intramammary Suspension
Overall summary of the scientific evaluation of Combimox Lactating Cow Intramammary Suspension
Denne undersøgelse tog også sigte på at give data om resterne af amoxicillin og clavulansyre i mælkeprøver fra (yver)området, der blev taget på regelmæssige tidspunkter efter infusion af Combimox og referencelægemidlet.
This study also served to provide data on the residues of amoxicillin and clavulanic measured in the (udder) quarter milk samples obtained at regular timepoints after infusion of Combimox and the reference product.
Ansøgeren fremførte endvidere, at Combimox' formulering lignede referencelægemidlets formulering så meget, at det muliggjorde en dispensation fra kravet om at fremlægge in vivo-data.
The applicant further claimed that the formulation of Combimox was sufficiently similar to the reference product to allow a waiver from the need to present in vivo data.
Til støtte for Combimox blev der fremsendt undersøgelser, hvor man sammenlignede det generiske lægemiddels og referencelægemidlets farmakokinetik for mælk og plasma.
In support of Combimox, studies were submitted to compare milk and plasma pharmacokinetics between the generic and reference products.
Lægemiddelform Styrke(r)
Pharmaceutical form
Combimox fås i dosissprøjter som en oliesuspension, der skal indgives intramammært.
Combimox is presented in unit-dose syringes as an oily suspension to be administered via the intramammary route.
Disse data gav imidlertid kun begrænsede sikkerhedsoplysninger.
However these data only gave limited safety information.
Tidsplanen for gennemførelse af aftalen er angivet i bilag V.
The timetable for the implementation of the agreement is set out in Annex V.
Overordnede konklusioner vedrørende sikkerheden
Overall safety conclusions
c. Alle indehavere af markedsføringstilladelse bør indføre risikominimeringsforanstaltninger.
c. All marketing authorisation holders should implement risk minimisation measures.
For oralt hexoprenalin er der meget få sikkerhedsdata.
For oral hexoprenaline there are very few safety data.
CMDh fandt dog, at der er behov for en mindre ændring af den foreslåede ordlyd i betingelserne for markedsføringstilladelserne (bilag IV).
However, the CMDh considered that a minor change was necessary to the wording proposed in the conditions to the Marketing Authorisations (Annex IV).
Produktinformationen for disse lægemidler bør ajourføres tilsvarende, og markedsføringstilladelserne skal derfor ændres.
The product information for these medicinal products should be updated accordingly; therefore these marketing authorisations should be varied.
For at fremme optimal sikker og effektiv anvendelse bør gestationsalderen derfor afspejle sig i indikationen.
Therefore, in order to help optimise safe and effective use, the gestational age should be reflected in the indication
Ca. 9 % af de 425 kvinder i disse undersøgelser blev eksponeret for den orale formulering, og ca. 2 % af de indberettede bivirkninger optrådte i forbindelse med den orale formulering af lægemidlet.
Approximately 9% of the 425 women in these trials were exposed to the oral formulation and approximately 2% of the reported adverse events were associated with the oral formulation of the drug.
Denne forsinkelse kan anvendes til at administrere glukokortikoider eller foretage andre tiltag til forbedring af den perinatale sundhedstilstand.
This delay may be used to administer glucocorticoids or to implement other measures known to improve perinatal health.
Desuden bør der gives særlig vejledning om administrationsmetode for disse injektionspræparater.
In addition specific guidance on the method of administration should be given for these injectable formulations.
Desuden er for tidlig fødsel en kendt risikofaktor for neonatal morbiditet og mortalitet.
Furthermore, premature delivery is an established risk factor of neonatal morbidity and mortality.
I to af indberetningerne udviklede takykardien sig videre og fik fatal udgang.
Two of the reports of tachycardia developed further and were fatal.
I perioden 2002-2012 blev der indberettet i alt 210 tilfælde, heraf mindst én bivirkning efter behandling med ritodrin.
During the period 2002-2012, a total of 210 cases including at least one adverse event after ritodrine treatment were reported.
Publicerede undersøgelser giver modstridende resultater og fortolkninger vedrørende sikkerheden af terbutalin (og beta-agonister) ved tokolyse.
Published studies deliver conflicting results and interpretations on the safety of terbutaline (and beta agonists) in tocolysis.
For disse specifikke produkter anbefaler PRAC, at produkterne tilbagekaldes.
For these specific products a recall of the products is being recommended by the PRAC.
CMDh-aftale
CMDh Agreement
I 10 kliniske undersøgelser med deltagelse af 425 gravide kvinder blev der kun indberettet ét tilfælde af henholdsvis angina pectoris og arytmi.
In 10 clinical studies comprising 425 pregnant women, angina pectoris and arrhythmia were reported only in one case each.
Behandlingen skal finde sted på behandlingssteder, der har det fornødne udstyr til kontinuerlig overvågning af moderens og fostrets helbredsstatus.
Treatment should be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetus health status.
Takykardi, palpitationer og blodtryksændringer tegnede sig for ca. to tredjedele af de bivirkninger, der er knyttet til den orale formulering.
Tachycardia, palpitations, and changes of blood pressure accounted for about 2/3 of the adverse events associated with the oral formulation.
Betingelserne for inddragelse af markedsføringstilladelserne for disse produkter, hvor dette er relevant, er angivet i bilag IV.
The conditions for the revocation of the marketing authorisations of these products, as applicable, are set out in Annex IV.
Begge formuleringer af hexoprenalin er desuden indiceret til immobilisering af uterus før, under og efter cervikal kirurgi.
Both formulations of hexoprenaline are also indicated for immobilisation of the uterus pre, during and post cerclage surgery.
Ungarn fandt, at det var i EU's interesse at indbringe sagen for PRAC, og udtrykte betænkelighed ved den dosering og de advarsler, der er anført i produktinformationen.
Hungary considered it was in the interest of the Union to refer the matter to the PRAC and expressed concerns with regards to the posology and warnings reflected in the product information.
Behandlingsvarigheden bør ikke overstige 48 timer, da data viser, at hovedvirkningen af tokolytisk behandling er forsinkelse af fødslen i op til 48 timer.
The duration of treatment should not exceed 48 hours as data show that the main effect of tocolytic therapy is a delay in delivery of up to 48 hours.
Uanset ovenstående er der fundet 18 alvorlige kardiovaskulære tilfælde i EudraVigilance, der viser, at ikke kun prædisponerede, men også raske personer har udviklet alvorlige kardiovaskulære komplikationer.
Regardless of this, 18 serious cardiovascular cases have been identified in EudraVigilance showing that, not only predisposed, but also otherwise healthy subjects have developed serious cardiovascular complications.
Derfor bør disse lægemidler ikke længere være omfattet af den obstetriske behandlingsindikation.
Therefore these medicinal products should no longer be indicated in the obstetrics therapeutic indication.
Fire patienter uden præeksisterende kardial patologi udviklede peripartum kardiomyopati under langvarig behandling med terbutalin af forskellig varighed (9,5-53 dage).
Four patients with no pre-existing cardiac pathology developed peripartum cardiomyopathy while on prolonged oral terbutaline for various treatment durations (9.5-53 days).
Risikoen for moderen og fostret vil kunne minimeres, hvis de aktive stoffer administreres af en obstetriker/læge med erfaring i brug af tokolytiske midler.
The risk to the mother and foetus could be minimised if active substances are administered by obstetricians/physicians experienced in the use of tocolytic agents.
Hibbard (1996) foretog en casekontrolundersøgelse af, om der er sammenhæng mellem langvarig anvendelse af terbutalin og peripartum kardiomyopati.
Hibbard (1996) performed a casecontrol study to investigate whether there is an association between long-term oral terbutaline use and peripartum cardiomyopathy.
Hertil hører tilstrækkelig vurdering af patientens kardiovaskulære status med EKG-overvågning i hele behandlingsperioden for at fastslå tidlig indsætten af kardiovaskulære hændelser og yderligere minimere risikoen for en alvorlig kardiovaskulær hændelse.
This should include an adequate assessment of the patient's cardiovascular status with monitoring by electrocardiogram (ECG) throughout treatment in order to identify the early onset of cardiovascular events and further minimise the risk of a serious cardiovascular event.
Oplysningerne om dødelige føtale eller neonatale udfald var ikke tilstrækkelige til at drage konklusioner om sammenhængen med intrauterin eksponering for terbutalin.
Information on fatal foetal or neonatal conditions was not sufficient to draw any conclusions on the association with intrauterine exposure to terbutaline.
Dette understreger igen vigtigheden af tæt lægelig overvågning under behandlingen og sætter tvivl ved ambulant tokolyse med terbutalin.
This again highlights the importance of close medical surveillance during therapy, and questions the safety of outpatient tocolysis with terbutaline.
Der blev i alt identificeret 98 indberetninger, som omfattede kardiovaskulære hændelser, der for størstedelen var hjertearytmier såsom takykardi eller palpitationer.
A total of 98 reports which included cardiovascular events were identified, the majority of which were cardiac arrhythmias, such as, tachycardia or palpitations.
Gennemgangen af alle kardiovaskulære hændelser for salbutamol viste, at dette lægemiddel kan medføre alvorlige kardiovaskulære bivirkninger, som kan være fatale for moderen og/eller fosteret.
The review of all cardiovascular events for salbutamol showed this medicinal product can induce serious cardiovascular adverse events, which can result in the death of the mother and/or foetus.
Ingen inhalationsformuleringer er godkendt til obstetriske indikationer.
There are no formulations for inhalation authorised in obstetric indications.
De skal administreres snarest muligt efter at diagnosen for tidlige veer er stillet, og efter at patienten er vurderet for kontraindikationer.
These should be administered as early as possible after the diagnosis of premature labour, and after evaluation of the patient to eliminate any contra-indications of use.
Nøje regulering af væskebalancen har afgørende betydning for at undgå risikoen for maternelt lungeødem.
Careful control of the level of hydration is essential to avoid the risk of maternal pulmonary oedema.
Maternel takykardi er den hyppigst indberettede bivirkning efter intravenøs administration af hexoprenalin.
Maternal tachycardia is the most commonly reported adverse reaction following intravenous hexoprenaline administration.
CMDh foreslog at afkorte tiden til tilbagekaldelse af de produkter, der kun havde obstetriske indikationer, og for hvilke markedsføringstilladelsen skal inddrages, for at sikre øjeblikkelig indgriben over for produkter uden markedsføringstilladelse.
The CMDh proposed to shorten the time for recall of the products with only obstetric indications and for which revocation is applicable to ensure that prompt action is taken on products with no marketing authorisation.
Nogle af de orale produkter eller suppositorier, der er omfattet af denne procedure, er kun godkendt til obstetriske indikationer.
Some of the products for oral use or suppositories referred in this procedure are authorised only in obstetric indications.
En gennemgang af sikkerhedsdata for fenoterol viste, at de kardiovaskulære hændelser takykardi og palpitationer ofte indberettes i kliniske undersøgelser og beskrives som meget almindelige bivirkninger af lægemidlet.
A review of safety data for fenoteral showed that the cardiovascular events tachycardia and palpitations were frequently reported in clinical studies and are listed as very common side effects of the drug.
Når disse indikationer ophæves i overensstemmelse med PRAC's anbefaling, vil det medføre inddragelse af markedsføringstilladelserne.
Removal of these indications as per the PRAC recommendation will result to the revocation of these marketing authorisations.
Som led i risikominimeringsforanstaltningerne foreslog PRAC reviderede indikationer for de parenterale formuleringer med hensyntagen til alle data og med præcisering af de tilstande, som disse produkter er indiceret til.
As part of the risk minimisation measures the PRAC proposed revised indications for the parenteral formulations taking all the data into account, and making clear the conditions for which these products are indicated.
Selv efter korrektion for potentielt konfunderende variable var der fortsat signifikant sammenhæng mellem langvarig oral terbutalin-behandling af for tidlige veer og efterfølgende peripartum kardiomyopati.
Even after correction of potentially confounding variables, the relationship remained significant between long-term oral terbutaline therapy for preterm labour and subsequent peripartum cardiomyopathy.
Modsat andre SABA er der ikke registreret maternel dødelighed og ingen tilfælde af myokardieinfarkt efter administration af hexoprenalin med henblik på tokolyse.
In contrast to other SABAs, no maternal fatality and no case of myocardial infarction have been reported following hexoprenaline administration for tocolysis.
Bortset fra indberetningerne om rhabdomyolyse og svære kutane bivirkninger svarede de fleste af disse tilfælde til den kendte sikkerhedsprofil af ritodrin.
With the exception of reports on rhabdomyolysis and SCARs, the cases were mostly in accordance with the known safety profile of ritodrine.
PRAC anbefalede desuden, at anvendelse af de parenterale formuleringer til ekstern vending og akutte situationer anses for fordelagtig, hvor disse indikationer i forvejen er godkendt.
The PRAC as well recommended that the use of the parental formulations for ECV and emergency is considered favourable where these indications are already authorised.
SABA må ikke anvendes hos kvinder med hjertesygdom i anamnesen eller i tilfælde, hvor moderens eller fosterets tilstand bevirker, at forlængelse af graviditeten er farlig.
SABAs should not be used in women with a history of heart disease or in conditions of the mother or foetus in which prolongation of the pregnancy is hazardous.
Der er stort set ingen evidens om maternel død i disse undersøgelser og meget begrænsede data om uønskede udfald for fostret (f.eks. takykardi, hypoinsulinæmi).
There is hardly any evidence of maternal death in these studies and very limited data on adverse foetal outcomes (e.g. tachycardia, hyperinsulinaemia).
a. For de orale formuleringer og suppositorieformuleringer, der kun er godkendt til de indikationer, som foreslås ophævet (i overensstemmelse med ændringerne af produktinformationen, der fremgår af bilag III), bør markedsføringstilladelserne inddrages og produkterne tages af markedet inden for de fastlagte frister.
a. Oral and suppository formulations which are only authorised in the indications proposed to be removed (in accordance with changes to the product information as set out in Annex III) should have their marketing authorisations revoked and should be recalled within given deadlines.
Patienterne bør overvåges tæt for tegn på kardiovaskulære bivirkninger i hele behandlingsperioden.
Patients should be closely monitored for signs of cardiovascular adverse reactions throughout treatment.
I betragtning af ovenstående konkluderede PRAC, at benefit/risk-forholdet på baggrund af alle de foreliggende sikkerhedsdata ikke er gunstigt for de orale formuleringer og suppositorierne, navnlig vedrørende risikoen for alvorlige kardiovaskulære hændelser, og den begrænsede virkning.
Having noted the above, the PRAC concluded that the benefit-risk balance is not favourable for the oral formulations and suppositories in view of the overall available safety data, in particular in relation to the risk of serious cardiovascular events, and limited efficacy.
anbefaler PRAC i henhold til bestemmelserne i artikel 31 og 32 i direktiv 2001/83/EF derfor ændring, eller i givet fald inddragelse, af markedsføringstilladelserne for alle lægemidler omhandlet i bilag I, for hvilke ændringerne i produktinformationen fremgår af bilag III til anbefalingen.
Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the PRAC recommends the variation to the terms of the marketing authorisations, or revocation, as applicable, for all medicinal products referred to in Annex I and for which the amendments to the product information are set out in Annex III of the recommendation.
Efter gennemgang af den kardiovaskulære bivirkningsprofil ved anvendelse af disse lægemidler til obstetriske indikationer konkluderede PRAC, at orale former og suppositorier ikke længere burde anvendes til hæmning af kontraktioner af livmoderen.
Having considered the cardiovascular adverse reactions profile associated with the use of these medicinal products in obstetric indications, the PRAC concluded that oral forms and suppositories should no longer be used to supress contractions of the womb.
Enkeltvis er der registreret mere alvorlige lægemiddelreaktioner - brystsmerter, dyspnø, ileus, bevidsthedstab, arytmi samt flere case-rapporter om lungeødem (fire i en publikation af Van Iddekinge et al., 1991, en i virksomhedens database, fire i PSUR).
More serious adverse drug reactions have been recorded individually - chest pain, dyspnoea, ileus, loss of consciousness, arrhythmia and also several case reports of pulmonary oedema (four in a publication by Van Iddekinge et al., 1991, one in the EV database, four in the PSUR) have been reported.
PRAC fandt alvorlige begrænsninger i data om virkning for orale formuleringer og suppositorieformuleringer og noterede sig den foreliggende nye evidens og/eller nuværende medicinske viden om anvendelsen af disse produkter til obstetriske indikationer.
The PRAC identified serious limitations of the efficacy data for oral and suppository formulations, and noted the available new evidence and/or current medical knowledge on the use of these products for obstetric indications.
For den orale tablet blev der indberettet tre alvorlige bivirkninger (bevidsthedstab, trismus og en alvorlig hudreaktion) og seks ikke-alvorlige bivirkninger.
For the oral tablet, three serious AEs were reported (loss of consciousness, trismus and a serious skin reaction), and six nonserious AEs for the tablet.