FrancophonIA/ELRC3.0 huggingface dataset:
English: A third study examined the use of Privigen for immunomodulation in 28 patients with CIDP who were given Privigen every three weeks over a period of 24 weeks.
Danish: I et tredje studie blev anvendelsen af Privigen som immunmodulerende middel undersøgt hos 28 patienter med CIDP, som fik Privigen hver tredje uge i løbet af en periode på 24 uger.
English: The second study looked at using Privigen in 57 patients with ITP.
Danish: I det andet studie blev Privigen anvendt hos 57 patienter med ITP.
English: The main measure of effectiveness was the number of patients who showed improvement of their disability, measured by a decrease on a 10point scale of disability in their arms and legs.
Danish: Virkningen blev hovedsageligt målt på antallet af patienter, som opnåede en bedring af deres handicap i arme og ben, målt ved et fald på en 10-punkts handicapskala.
English: The medicine is available as a solution for infusion (drip) into a vein.
Danish: Lægemidlet fås som en væske (opløsning) til infusion (drop) i en vene.
English: In the first study, Privigen was used in 80 patients with PID, with the medicine being infused every three or four weeks.
Danish: I det første studie blev Privigen anvendt hos 80 patienter med PID, idet lægemidlet blev givet som infusion hver tredje eller fjerde uge.
English: Some side effects are more likely with a high rate of infusion, in patients with low immunoglobulin levels, or in patients who have not received human normal immunoglobulin before or for a long time.
Danish: Nogle bivirkninger er mere tilbøjelige til at opstå, hvis infusionshastigheden er høj, hos patienter med et lavt indhold af immunglobulin, eller hos patienter, der ikke har fået humant normalt immunglobulin før eller ikke har fået det i lang tid.
English: For the full list of all side effects with Privigen, see the package leaflet.
Danish: Den fuldstændige liste over alle bivirkninger ved Privigen fremgår af indlægssedlen.
English: These also include people who have developed a lack of antibodies after birth (secondary immunodeficiency syndrome, SID), who have low levels of certain antibodies (called IgG) and who suffer from infections that are severe, keep coming back, and are not cured by medicines used to treat infections.
Danish: De kan også være personer, som har udviklet en mangel på antistoffer efter fødslen (sekundært immundefektsyndrom (SID)), som har lave niveauer af visse antistoffer (kaldet IgG), og som lider af alvorlige infektioner, der er tilbagevendende og ikke kan helbredes ved hjælp af lægemidler til behandling af infektioner
English: Privigen must not be used in people who are hypersensitive (allergic) to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Danish: Privigen må ikke anvendes hos personer, der er allergiske over for normalt humant immunglobulin eller nogen af de andre indholdsstoffer, eller hos patienter med allergi over for andre typer immunglobulin, navnlig hvis de har et meget lavt indhold af immunglobulin A (IgA) og danner antistoffer mod IgA.
English: How is Privigen used?
Danish: Hvordan anvendes Privigen?
English: What benefits of Privigen have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Privigen?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Privigen have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Privigen.
English: O MA (EU) number (Invented) name
Danish: MF (EU)-nummer
English: Co. Down BT35 6JP Northern Ireland
Danish: Co. Down BT35 6JP Nordirland
English: The application was submitted to the Concerned Member State, Ireland, under the mutual recognition procedure.
Danish: Ansøgningen blev indgivet til den berørte medlemsstat, Irland, i henhold til den gensidige anerkendelsesprocedure.
English: Combimox was authorised in the United Kingdom on 9 May 2003 under Article 13(1) of Directive 2001/82/EC.
Danish: Combimox blev godkendt i Det Forenede Kongerige den 9. maj 2003 i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF.
English: Consequently the matter was referred to the CVMP
Danish: Som følge heraf blev sagen indbragt for CVMP.
English: Amoxicillin 200 mg Clavulanic acid 50 mg Prednisolone 10 mg
Danish: Amoxicillin 200 mg Clavulansyre 50 mg Prednisolon 10 mg
English: • the efficacy of Combimox was not confirmed;
Danish: • Combimox' virkning var ikke bekræftet;
English: Not established
Danish: Ikke fastlagt
English: Ireland considered that the authorisation of Combimox may present a potential serious risk to human and animal health since the safety and efficacy of the product had not been sufficiently demonstrated.
Danish: Irland var af den opfattelse, at godkendelsen af Combimox kunne udgøre en potentiel alvorlig risiko for menneskers og dyrs sundhed, eftersom lægemidlets sikkerhed og virkning ikke var blevet tilstrækkeligt påvist.
English: The CVMP was asked to give its opinion on the concerns raised by Ireland and to conclude on the benefit/risk balance for Combimox.
Danish: CVMP blev anmodet om at afgive udtalelse om de betænkeligheder, som Irland havde givet udtryk for, og om at drage en konklusion om risk/benefit-forholdet for Combimox.
English: Therefore the CVMP concluded that the particulars submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC and recommended the refusal of granting the Marketing Authorisation in the Concerned Member State and the suspension of the existing Marketing Authorisation in the Reference Member State.
Danish: CVMP konkluderede således, at de oplysninger, der er fremsendt til støtte for ansøgningen, ikke er i overensstemmelse med artikel 13 i direktiv 2001/82/EF, og anbefalede afslag på ansøgningen om markedsføringstilladelse i den berørte medlemsstat og suspendering af den eksisterende markedsføringstilladelse i referencemedlemsstaten.
English: The applicant presented comparative viscosity data between the ‘old' and ‘new' formulations of Combimox.
Danish: Ansøgeren fremlagde komparative viskositetsdata for de "gamle" og de "nye" formuleringer af Combimox.
English: • the proposed withdrawal period for Combimox was insufficiently substantiated;
Danish: • den foreslåede tilbageholdelsestid for Combimox var utilstrækkeligt dokumenteret;
English: 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.
Danish: 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.
English: Lactating cattle
Danish: Diegivende kvæg
English: Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals
Danish: Intramammær indgivelse til diegivende kvæg i en dosis på 3 sprøjter pr. berørt område, indgivet enkeltvis med 12 timers mellemrum
English: 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.
Danish: 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.
English: Three comparative pharmacokinetic studies were carried out with Combimox and the reference product, all with a two-period cross-over design.
Danish: Der blev foretaget tre komparative farmakokinetiske undersøgelser med Combimox og referencelægemidlet, alle med et toperiodes overkrydsningsdesign.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: Appropriate clinical data should be provided to confirm the efficacy of Combimox Lactating Cow Intramammary Suspension.
Danish: Der skal fremlægges tilstrækkelige kliniske data for at dokumentere virkningen af Combimox Lactating Cow Intramammary Suspension.
English: 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.
Danish: 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.
English: 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.
Danish: Combimox Lactating Cow Intramammary Suspension (herefter kaldet Combimox) er en intramammær suspension, der indeholder amoxicillin (som amoxicillintrihydrat), clavulansyre (som kaliumclavulanat) og prednisolon.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Grounds for refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisation
Danish: Begrundelser for afslag på ansøgningen om markedsføringstilladelse og suspendering af den eksisterende markedsføringstilladelse
English: Overall summary of the scientific evaluation of Combimox Lactating Cow Intramammary Suspension
Danish: Samlet resumé af den videnskabelige vurdering af Combimox Lactating Cow Intramammary Suspension
English: 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.
Danish: 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.
English: 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.
Danish: Ansøgeren fremførte endvidere, at Combimox' formulering lignede referencelægemidlets formulering så meget, at det muliggjorde en dispensation fra kravet om at fremlægge in vivo-data.
English: In support of Combimox, studies were submitted to compare milk and plasma pharmacokinetics between the generic and reference products.
Danish: Til støtte for Combimox blev der fremsendt undersøgelser, hvor man sammenlignede det generiske lægemiddels og referencelægemidlets farmakokinetik for mælk og plasma.
English: Pharmaceutical form
Danish: Lægemiddelform Styrke(r)
English: Combimox is presented in unit-dose syringes as an oily suspension to be administered via the intramammary route.
Danish: Combimox fås i dosissprøjter som en oliesuspension, der skal indgives intramammært.
English: However these data only gave limited safety information.
Danish: Disse data gav imidlertid kun begrænsede sikkerhedsoplysninger.
English: The timetable for the implementation of the agreement is set out in Annex V.
Danish: Tidsplanen for gennemførelse af aftalen er angivet i bilag V.
English: Overall safety conclusions
Danish: Overordnede konklusioner vedrørende sikkerheden
English: c. All marketing authorisation holders should implement risk minimisation measures.
Danish: c. Alle indehavere af markedsføringstilladelse bør indføre risikominimeringsforanstaltninger.
English: For oral hexoprenaline there are very few safety data.
Danish: For oralt hexoprenalin er der meget få sikkerhedsdata.
English: However, the CMDh considered that a minor change was necessary to the wording proposed in the conditions to the Marketing Authorisations (Annex IV).
Danish: CMDh fandt dog, at der er behov for en mindre ændring af den foreslåede ordlyd i betingelserne for markedsføringstilladelserne (bilag IV).
English: The product information for these medicinal products should be updated accordingly; therefore these marketing authorisations should be varied.
Danish: Produktinformationen for disse lægemidler bør ajourføres tilsvarende, og markedsføringstilladelserne skal derfor ændres.
English: Therefore, in order to help optimise safe and effective use, the gestational age should be reflected in the indication
Danish: For at fremme optimal sikker og effektiv anvendelse bør gestationsalderen derfor afspejle sig i indikationen.
English: 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.
Danish: 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.
English: This delay may be used to administer glucocorticoids or to implement other measures known to improve perinatal health.
Danish: Denne forsinkelse kan anvendes til at administrere glukokortikoider eller foretage andre tiltag til forbedring af den perinatale sundhedstilstand.
English: In addition specific guidance on the method of administration should be given for these injectable formulations.
Danish: Desuden bør der gives særlig vejledning om administrationsmetode for disse injektionspræparater.
English: Furthermore, premature delivery is an established risk factor of neonatal morbidity and mortality.
Danish: Desuden er for tidlig fødsel en kendt risikofaktor for neonatal morbiditet og mortalitet.
English: Two of the reports of tachycardia developed further and were fatal.
Danish: I to af indberetningerne udviklede takykardien sig videre og fik fatal udgang.
English: During the period 2002-2012, a total of 210 cases including at least one adverse event after ritodrine treatment were reported.
Danish: I perioden 2002-2012 blev der indberettet i alt 210 tilfælde, heraf mindst én bivirkning efter behandling med ritodrin.
English: Published studies deliver conflicting results and interpretations on the safety of terbutaline (and beta agonists) in tocolysis.
Danish: Publicerede undersøgelser giver modstridende resultater og fortolkninger vedrørende sikkerheden af terbutalin (og beta-agonister) ved tokolyse.
English: For these specific products a recall of the products is being recommended by the PRAC.
Danish: For disse specifikke produkter anbefaler PRAC, at produkterne tilbagekaldes.
English: CMDh Agreement
Danish: CMDh-aftale
English: In 10 clinical studies comprising 425 pregnant women, angina pectoris and arrhythmia were reported only in one case each.
Danish: I 10 kliniske undersøgelser med deltagelse af 425 gravide kvinder blev der kun indberettet ét tilfælde af henholdsvis angina pectoris og arytmi.
English: Treatment should be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetus health status.
Danish: Behandlingen skal finde sted på behandlingssteder, der har det fornødne udstyr til kontinuerlig overvågning af moderens og fostrets helbredsstatus.
English: Tachycardia, palpitations, and changes of blood pressure accounted for about 2/3 of the adverse events associated with the oral formulation.
Danish: Takykardi, palpitationer og blodtryksændringer tegnede sig for ca. to tredjedele af de bivirkninger, der er knyttet til den orale formulering.
English: The conditions for the revocation of the marketing authorisations of these products, as applicable, are set out in Annex IV.
Danish: Betingelserne for inddragelse af markedsføringstilladelserne for disse produkter, hvor dette er relevant, er angivet i bilag IV.
English: Both formulations of hexoprenaline are also indicated for immobilisation of the uterus pre, during and post cerclage surgery.
Danish: Begge formuleringer af hexoprenalin er desuden indiceret til immobilisering af uterus før, under og efter cervikal kirurgi.
English: 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.
Danish: 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.
English: 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.
Danish: Behandlingsvarigheden bør ikke overstige 48 timer, da data viser, at hovedvirkningen af tokolytisk behandling er forsinkelse af fødslen i op til 48 timer.
English: 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.
Danish: 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.
English: Therefore these medicinal products should no longer be indicated in the obstetrics therapeutic indication.
Danish: Derfor bør disse lægemidler ikke længere være omfattet af den obstetriske behandlingsindikation.
English: Four patients with no pre-existing cardiac pathology developed peripartum cardiomyopathy while on prolonged oral terbutaline for various treatment durations (9.5-53 days).
Danish: Fire patienter uden præeksisterende kardial patologi udviklede peripartum kardiomyopati under langvarig behandling med terbutalin af forskellig varighed (9,5-53 dage).
English: 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.
Danish: Risikoen for moderen og fostret vil kunne minimeres, hvis de aktive stoffer administreres af en obstetriker/læge med erfaring i brug af tokolytiske midler.
English: Hibbard (1996) performed a casecontrol study to investigate whether there is an association between long-term oral terbutaline use and peripartum cardiomyopathy.
Danish: Hibbard (1996) foretog en casekontrolundersøgelse af, om der er sammenhæng mellem langvarig anvendelse af terbutalin og peripartum kardiomyopati.
English: 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.
Danish: 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.
English: Information on fatal foetal or neonatal conditions was not sufficient to draw any conclusions on the association with intrauterine exposure to terbutaline.
Danish: Oplysningerne om dødelige føtale eller neonatale udfald var ikke tilstrækkelige til at drage konklusioner om sammenhængen med intrauterin eksponering for terbutalin.
English: This again highlights the importance of close medical surveillance during therapy, and questions the safety of outpatient tocolysis with terbutaline.
Danish: Dette understreger igen vigtigheden af tæt lægelig overvågning under behandlingen og sætter tvivl ved ambulant tokolyse med terbutalin.
English: A total of 98 reports which included cardiovascular events were identified, the majority of which were cardiac arrhythmias, such as, tachycardia or palpitations.
Danish: Der blev i alt identificeret 98 indberetninger, som omfattede kardiovaskulære hændelser, der for størstedelen var hjertearytmier såsom takykardi eller palpitationer.
English: 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.
Danish: 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.
English: There are no formulations for inhalation authorised in obstetric indications.
Danish: Ingen inhalationsformuleringer er godkendt til obstetriske indikationer.
English: 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.
Danish: De skal administreres snarest muligt efter at diagnosen for tidlige veer er stillet, og efter at patienten er vurderet for kontraindikationer.
English: Careful control of the level of hydration is essential to avoid the risk of maternal pulmonary oedema.
Danish: Nøje regulering af væskebalancen har afgørende betydning for at undgå risikoen for maternelt lungeødem.
English: Maternal tachycardia is the most commonly reported adverse reaction following intravenous hexoprenaline administration.
Danish: Maternel takykardi er den hyppigst indberettede bivirkning efter intravenøs administration af hexoprenalin.