FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no experience with repeat administration of ZINPLAVA in patients with CDI.
Danish: Der er ingen erfaring med gentagen administration af ZINPLAVA til patienter med CDI.
English: Driving and using machines ZINPLAVA has no or very little effect on the ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Zinplava påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Infusion related reactions
Danish: Infusionsreaktioner
English: Type I glass vial containing 40 mL solution, with a chlorobutyl stopper, and a flip-off cap seal.
Danish: 40 ml koncentrat i et type I-hætteglas med chlorbutylprop og forseglet med et flip-off-låg.
English: There were no notable effects in the male and female reproductive organs in mice based on repeat dose toxicity studies and no binding to reproductive tissues was observed in tissue cross-reactivity studies.
Danish: Der var ingen nævneværdig indvirkning på forplantningsorganerne hos han- og hunmus i toksicitetsstudier efter gentagne doser, og der blev ikke observeret binding af bezlotoxumab til reproduktionsvæv i studier af krydsreaktivitet i væv.
English: • you are allergic to bezlotoxumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for bezlotoxumab eller et af de øvrige indholdsstoffer i Zinplava
English: • If you are breast-feeding or are planning to breast-feed, check with your doctor first.
Danish: • Hvis du ammer eller planlægger at amme, skal du først spørge lægen til råds.
English: The adverse reactions after the second dose were not markedly different from those observed after the first dose, and are consistent with adverse reactions observed in the two Phase 3 trials (MODIFY I and MODIFY II; see section 5.1) in which all patients received a single dose.
Danish: Bivirkningerne efter den anden dosis var ikke markant forskellige fra de bivirkninger, der blev set efter den første dosis, og stemmer overens med de bivirkninger, der blev set i de to fase 3studier (MODIFY I og MODIFY II; se pkt.
English: Clinical trials
Danish: Kliniske studier
English: ZINPLAVA is a clear to moderately opalescent, colourless to pale yellow liquid.
Danish: ZINPLAVA er en klar til moderat opaliserende, farveløs til svagt gul væske.
English: Animal reproduction or developmental toxicity studies have not been conducted with bezlotoxumab.
Danish: Der er ikke udført studier af reproduktions- eller udviklingstoksicitet med bezlotoxumab hos dyr.
English: ZINPLAVA contains the active substance bezlotoxumab.
Danish: Zinplava indeholder det aktive stof bezlotoxumab.
English: Table 1 presents the adverse reactions reported within 4 weeks of infusion in ZINPLAVA-treated patients and listed by System Organ Class.
Danish: I tabel 1 vises de bivirkninger, der er rapporteret inden for 4 uger efter infusion hos ZINPLAVA-behandlede patienter.
English: The effect of renal impairment on the pharmacokinetics of bezlotoxumab was evaluated in patients with mild (eGFR 60 to < 90 mL/min/1.73 m 2), moderate (eGFR 30 to < 60 mL/min/1.73 m 2), or severe
Danish: Indvirkningen af nedsat nyrefunktion på bezlotoxumabs farmakokinetik blev vurderet hos patienter med let nedsat (eGFR 60 til < 90 ml/min/1,73 m2), moderat nedsat (eGFR 30 til < 60 ml/min/1,73 m eller svært nedsat (eGFR 15 til < 30 ml/min/1,73 m2) nyrefunktion eller med terminal nyresygdom
English: Clear to moderately opalescent, colourless to pale yellow liquid.
Danish: Klar til moderat opaliserende, farveløs til svagt gul væske.
English: There was no binding of bezlotoxumab to reproductive tissue in tissue cross reactivity studies, and no notable effects in the male and female reproductive organs in repeat dose toxicity studies in mice (see section 5.3).
Danish: Bezlotoxumab bindes ikke til reproduktionsvæv i studier af krydsreaktivitet i væv, og der blev ikke fundet nogen betydningsfuld indvirkning på forplantningssorganerne hos han- og hunmus i toksicitetsstudier med gentagne doser (se pkt.
English: Infusion specific adverse reactions reported in ≥ 0.5 % of subjects receiving ZINPLAVA and at a frequency greater than placebo were nausea (3 %), fatigue (1 %), pyrexia (1 %), dizziness (1 %), headache (2 %), dyspnoea (1 %) and hypertension (1 %).
Danish: De infusionsreaktioner, der blev rapporteret hos ≥ 0,5 % patienterne i ZINPLAVAgruppen og hyppigere end med placebo, var kvalme (3 %), træthed (1 %), pyreksi (1 %),
English: ZINPLAVA is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI (see sections 4.2, 4.4 and 5.1).
Danish: ZINPLAVA er indiceret til forebyggelse af recidiv af Clostridium difficile-infektion (CDI) hos voksne med høj risiko for recidiv af CDI (se pkt.
English: Serious adverse reactions
Danish: Alvorlige bivirkninger
English: These adverse reactions were reported at a similar frequency in placebo treated patients compared with ZINPLAVA treated patients.
Danish: Disse bivirkninger blev rapporteret med samme hyppighed hos patienter i placebogruppen og i ZINPLAVA-gruppen.
English: No clinically meaningful differences in the exposure of bezlotoxumab were found between elderly patients 65 years and older and patients under 65 years of age.
Danish: Der blev ikke fundet klinisk relevante forskelle i eksponeringen for bezlotoxumab mellem patienter ≥ 65 år og patienter < 65 år.
English: What you need to know before you are given ZINPLAVA
Danish: Det skal du vide, før du får Zinplava
English: See leaflet.
Danish: Se indlægssedlen.
English: Infected with 027 ribotype n = Number of patients within subgroup that met the criteria for endpoint m = Number of patients within subgroup
Danish: n = Antal patienter i subgruppen, der opfyldte endepunktskriterierne.
English: ZINPLAVA should be administered during the course of antibacterial therapy for CDI.
Danish: ZINPLAVA skal administreres samtidigt med et antibakterielt behandlingsforløb mod CDI.
English: How ZINPLAVA works
Danish: Sådan virker Zinplava
English: ZINPLAVA 25 mg/mL concentrate for solution for infusion
Danish: ZINPLAVA 25 mg/ml koncentrat til infusionsvæske, opløsning
English: (eGFR < 15 mL/min/1.73 m 2), as compared to patients demonstrating normal (eGFR
Danish: (ESRD) (eGFR < 15 ml/min/1,73 m2) i forhold til patienter med normal (eGFR ≥ 90 ml/min/1,73 m nyrefunktion.
English: What ZINPLAVA contains - The active substance is bezlotoxumab.
Danish: Zinplava indeholder: - Aktivt stof: bezlotoxumab.
English: How you are given ZINPLAVA
Danish: Sådan får du Zinplava
English: ZINPLAVA is given with the antibiotic therapy you are taking for CDI.
Danish: Zinplava gives samtidig med, at du tager antibiotisk behandling mod CDI.
English: No clinically meaningful differences in the exposure of bezlotoxumab were found between patients with renal impairment and patients with normal renal function.
Danish: Der blev ikke fundet klinisk relevante forskelle i eksponeringen for bezlotoxumab mellem patienter med nedsat leverfunktion og patienter med normal leverfunktion.
English: ZINPLAVA 25 mg/mL concentrate for solution for infusion bezlotoxumab
Danish: Zinplava 25 mg/ml koncentrat til infusionsvæske, opløsning bezlotoxumab
English: • If the diluted solution is refrigerated, allow the IV bag to come to room temperature prior to use.
Danish: • Hvis den fortyndede infusionsvæske har været opbevaret i køleskab, skal i.v.-infusionsposen have tid til at opnå stuetemperatur før brug.
English: - The other ingredients are citric acid monohydrate (E330), diethylenetriaminepentaacetic acid, polysorbate 80 (E433), sodium chloride, sodium citrate dihydrate (E331), water for injections, and sodium hydroxide (E524) (for pH adjustment).
Danish: polysorbat 80 (E433), natriumchlorid, natriumcitratdihydrat (E331), vand til injektionsvæsker og natriumhydroxid (E524) (til justering af pH).
English: Immune-related adverse reactions
Danish: Immunrelaterede bivirkninger
English: Sodium hydroxide (E524) (for pH adjustment).
Danish: Natriumcitratdihydrat (E331) Vand til injektionsvæsker Natriumhydroxid (E524) (til justering af pH).
English: • Do not freeze the diluted solution.
Danish: • Den fortyndede infusionsvæske må ikke nedfryses.
English: ZINPLAVA is a medicine that is given together with an antibiotic to prevent Clostridium difficile infection (CDI) from coming back in patients 18 years of age or older who have a high risk of CDI coming back.
Danish: Zinplava er et lægemiddel, der gives samtidigt med et antibiotikum (bakteriedræbende middel), for at forhindre, at en infektion med bakterien Clostridium difficile kommer igen.
English: If refrigerated, allow the IV bag to come to room temperature prior to use.
Danish: Hvis den fortyndede infusionsvæske har været opbevaret i køleskab, skal i.v.-infusionsposen have tid til at opnå stuetemperatur før brug.
English: Each mL contains 25 mg bezlotoxumab.
Danish: Hver ml indeholder 25 mg bezlotoxumab.
English: Full Analysis Set = a subset of all randomised patients with exclusions for: (i) did not receive infusion of study medication, (ii) did not have a positive local stool test for toxigenic C. difficile; (iii) did not receive protocol defined standard of care therapy within a 1 day window of the infusion SoC = Standard of Care antibacterial (metronidazole or vancomycin or fidaxomicin) Based on the Miettinen and Nurminen method without stratification Based on medical conditions or medications received that may result in immunosuppression Zar score ≥ 2
Danish: Fuldt analysesæt = En undergruppe af alle randomiserede patienter, hvor følgende ikke var medtaget: (i) fik ikke infusion af studiemedicin, (ii) der forelå ikke en positiv fæcestest for toksindannende C. difficile, (iii) fik ikke protokoldefineret standardbehandling inden for en tidsramme på 1 dag fra infusionen og (iiii) manglende efterlevelse af GCP (good clinical practice).
English: ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1).
Danish: ZINPLAVA skal administreres samtidigt med et antibakterielt behandlingsforløb mod CDI (se pkt.
English: Hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion Det er ikke nødvendigt at justere dosis hos patienter med nedsat leverfunktion (se pkt.
English: Do not store any unused portion of the infusion solution for reuse.
Danish: Eventuelle rester af koncentrat eller infusionsvæske må ikke genbruges.
English: Placebo with SoC Percent (n/N)
Danish: Placebo plus SoC Procent (n/N)
English: ZINPLAVA with SoC Percent (n/m)
Danish: ZINPLAVA plus SoC Procent (n/m)
English: Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Danish: Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion (se pkt.
English: ZINPLAVA with SoC Percent (n/N)
Danish: ZINPLAVA plus SoC Procent (n/N)
English: Each mL of concentrate contains 25 mg bezlotoxumab.
Danish: Hver ml koncentrat indeholder 25 mg bezlotoxumab.
English: • Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution.
Danish: Hætteglasset/hætteglassene kan også opbevares ved stuetemperatur beskyttet mod lys i op til 24 timer før fremstilling af den fortyndede infusionsvæske.
English: One 40 mL vial contains 1,000 mg of bezlotoxumab.
Danish: Et 40 ml hætteglas indeholder 1.000 mg bezlotoxumab.
English: What ZINPLAVA looks like and contents of the pack The concentrate for solution for infusion is a clear to moderately opalescent, colourless to pale yellow liquid.
Danish: Koncentratet til infusionsvæske, opløsning, er en klar til moderat opaliserende, farveløs til svagt gul væske.
English: Each 40 mL vial contains 1,000 mg bezlotoxumab.
Danish: Hvert 40 ml hætteglas indeholder 1.000 mg bezlotoxumab.
English: Each vial contains 1,000 mg bezlotoxumab.
Danish: Hvert hætteglas indeholder 1.000 mg bezlotoxumab.
English: Frequency Adverse Reaction(s)
Danish: Bivirkning(er)
English: 7 May 2015
Danish: 7. maj 2015
English: What were the CVMP's main concerns that led to the refusal?
Danish: Hvori bestod CVMP's vigtigste betænkeligheder, der førte til afslaget?
English: The company that applied for authorisation is Le Vet Beheer B.V.
Danish: Den virksomhed, der har indgivet ansøgningen, er Le Vet Beheer B.V.
English: The CVMP therefore maintained its recommendation that the marketing authorisation be refused.
Danish: CVMP fastholder derfor sin anbefaling om at give afslag på markedsføringstilladelse.
English: At the time of the initial evaluation, the CVMP considered that there were deficiencies in the way the field study had been designed and conducted and the results had been presented.
Danish: På tidspunktet for den oprindelige evaluering var CVMP af den opfattelse, at der var mangler i den måde, hvorpå feltstudiet var designet og blev gennemført, samt i den måde, hvorpå resultaterne blev fremlagt.
English: As part of its application the company presented the results of a field study involving cats with blood pressure of 160 mmHg or above.
Danish: Som led i ansøgningen har virksomheden fremlagt resultaterne af et feltstudie af katte med et blodtryk på 160 mmHg eller derover.
English: The study had two parts, an initial part with 19 cats, 11 of which were treated with Lodipressin and 8 of which received placebo (a dummy treatment) for two weeks.
Danish: Studiet bestod af to dele: en indledende del med 19 katte, hvoraf 11 blev behandlet med Lodipressin og 8 med placebo (inaktivt stof) i to uger.
English: What is Lodipressin?
Danish: Hvad er Lodipressin?
English: Lodipressin is a veterinary medicine that contains the active substance amlodipine besilate.
Danish: Lodipressin er et lægemiddel til dyr, der indeholder det aktive stof amlodipinbesilat.
English: This means that it blocks channels on the surface of cells through which calcium normally enters the cell.
Danish: Det betyder, at midlet blokerer de kanaler på cellernes overflade (kalciumkanalerne), hvorigennem kalcium normalt trænger ind i cellerne.
English: In addition, there were concerns that the safety of the medicine had not been fully demonstrated and one unresolved quality issue.
Danish: Desuden havde CVMP den betænkelighed, at sikkerheden ved lægemidlet ikke var fuldt ud påvist, og at der var et problem med kvaliteten, som ikke var blevet løst.
English: After considering the grounds for this request, the CVMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 7 May 2015.
Danish: Efter en drøftelse af begrundelserne for denne anmodning revurderede CVMP den oprindelige udtalelse og bekræftede anbefalingen af afslag på ansøgningen om markedsføringstilladelse den 7. maj 2015.
English: Refusal of the marketing authorisation for Lodipressin (amlodipine besilate) EMA/55773/2016
Danish: Afslag på ansøgningen om markedsføringstilladelse for Lodipressin (amlodipinbesilat) EMA/55773/2016
English: On 15 January 2015, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lodipressin, intended for the treatment of systemic arterial hypertension in cats.
Danish: Den 15. januar 2015 vedtog Udvalget for Lægemidler til Dyr (CVMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Lodipressin, der er beregnet til behandling af systemisk arteriel hypertension (forhøjet blodtryk) hos katte.
English: Lodipressin was expected to be used to treat cats with systemic arterial hypertension (high blood pressure).
Danish: Lodipressin skulle anvendes til behandling af katte med systemisk arteriel hypertension (forhøjet blodtryk).
English: Refusal of the marketing authorisation for Lodipressin (amlodipine besilate)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Lodipressin (amlodipinbesilat)
English: What was Lodipressin expected to be used for?
Danish: Hvad forventedes Lodipressin anvendt til?
English: By reducing the entry of calcium into these cells, amlodipine prevents the blood vessel from contracting, thus lowering the blood pressure.
Danish: Ved at reducere mængden af kalcium til cellerne forhindrer amlodipin blodkarrene i at trække sig sammen, hvorved blodtrykket sænkes.
English: During the re-examination, the CVMP considered advice from an expert group in feline medicine.
Danish: Under den fornyede overvejelse har CVMP taget hensyn til rådgivningen fra en ekspertgruppe i sygdomme hos katte.
English: How is Lodipressin expected to work?
Danish: Hvordan forventes Lodipressin at virke?
English: The expert group advised that although the field study showed some evidence of a reduction in blood pressure, the many shortcomings in the study did not allow to conclude that the benefits of Lodipressin in the treatment of high blood pressure in cats outweigh the risks.
Danish: Ekspertgruppen har udtalt, at selv om feltstudiet i nogen grad har påvist en sænkning af blodtrykket, har det på grund af de mange mangler i studiet ikke været muligt at konkludere, at fordelene ved Lodipressin ved behandling af katte med forhøjet blodtryk opvejer risiciene.
English: This meant that whilst there is some evidence that Lodipressin is effective in lowering blood pressure, no firm conclusions could be drawn on its effectiveness for treatment of high blood pressure in cats.
Danish: Det betød, at selv om der fandtes nogen dokumentation for, at Lodipressin kunne sænke blodtrykket, kunne der ikke fremsættes en endelig konklusion om dets virkning ved behandling af katte med forhøjet blodtryk.
English: When calcium enters the cells in the blood vessel walls this causes contraction.
Danish: Når kalcium trænger ind i blodkarvæggene, forårsager det en sammentrækning.
English: In the second part, 23 cats received Lodipressin for 16 weeks with no placebo group.
Danish: I studiets anden del fik 23 katte Lodipressin i 16 uger.
English: Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: These include (but are not limited to):
Danish: Disse omfatter (men er ikke begrænset til):
English: If this happens within:
Danish: Hvis dette sker inden for:
English: All patients were clinically cured.
Danish: Alle patienter blev klinisk helbredt.
English: You or your child can drink water at any time.
Danish: Du eller dit barn kan til enhver tid drikke vand.
English: The mixture should be used immediately after preparation.
Danish: Blandingen skal anvendes straks efter den forberedes.
English: Take one dose on each day.
Danish: Tag en dosis hver dag.
English: Date of first authorisation: 27 October 2011 Date of latest renewal: 09 September 2016
Danish: Dato for første markedsføringstilladelse: 27. oktober 2011 Dato for seneste fornyelse: September 09, 2016
English: It is not known whether these toxic effects are reversible.
Danish: Det er ukendt, om disse toksiske virkninger er reversible.
English: Most of the side effects are not severe and normally disappear within a few days or weeks after treatment.
Danish: De fleste bivirkninger er ikke alvorlige, og forsvinder normalt i løbet af få dage eller uger efter behandlingen.
English: - Severe malaria according to WHO definition.
Danish: - Svær malaria ifølge WHO's definitioner.
English: − At the request of the European Medicines Agency.
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: (1) This CI is asymptotic because the exact CI could not be computed
Danish: (1)Denne CI er asymptotisk, da det præcise CI ikke kunne beregnes
English: Your doctor will advise you when these readings will be taken.
Danish: Din læge vil informere dig om hvornår disse aflæsninger vil tages.
English: Take at least 3 hours before or after food.
Danish: Tages mindst 3 timer før eller efter mad.
English: Do not use this medicine if you notice the blister is open.
Danish: Brug ikke lægemidlet, hvis du bemærker, at blisteren er åben.
English: The daily dose depends on the patient's body weight.
Danish: Den daglige dosis afhænger af patientens legemsvægt.
English: The table in this section is for adult patients only.
Danish: Tabellen i dette afsnit gælder kun voksne patienter.
English: You or your child should take this medicine on an empty stomach.
Danish: Du eller dit barn skal tage denne medicin på en tom mave.
English: Never take more than one dose on the same day to make up for a missed dose.
Danish: Tag aldrig mere end en dosis på samme dag som erstatning for den glemte dosis.
English: The exposure of pregnant women during the 2nd and 3rd trimester was not associated with any harm of the unborn child.
Danish: Eksponering af gravide kvinder i det 2. og 3. trimester har ikke været forbundet med nogen skade på det ufødte barn.
English: The majority of paediatric experience is derived from African children aged 6 months to 5 years.
Danish: Størsteparten af den pædiatrisk erfaring stammer fra afrikanske børn i alderen 6 måneder til 5 år.
English: • 31-60 minutes, half the dose must be taken again.
Danish: • 31-60 minutter, halvdelen af dosis skal tages igen.
English: Daily dose (mg)
Danish: Daglig dosis (mg)
English: • The ECG monitoring recommendations.
Danish: • Anbefalinger for EKG-overvågning.
English: • is female, elderly (over 65 years) or vomiting;
Danish: • er kvinde, ældre (over 65 år) eller kaster op,
English: This inhibitory effect was no longer evident one week after last administration of Eurartesim.
Danish: Denne hæmmende virkning var ikke længere evident en uge efter sidste administration af Eurartesim.
English: Your doctor should have prescribed a dose that is appropriate for your weight or your child's weight as follows:
Danish: Din læge bør have ordineret den dosis, der er hensigtsmæssig for din vægt eller dit barns vægt, på følgende måde:
English: Taking this medicine, if the malaria infection returns
Danish: Indtagelse af denne medicin, hvis malariainfektionen vender tilbage
English: Re-dosing with Eurartesim should not be attempted more than once.
Danish: Gentagen dosering med Euratesim må ikke forsøges mere end én gang.
English: • has recently (for example within about one month) been treated for malaria with certain medicines or has taken certain medicines to prevent malaria.
Danish: - er for nyligt (for eksempel inden for ca. en måned) blevet behandlet for malaria med visse former for medicin, eller har taget visse former for medicin for at undgå malaria.
English: No carcinogenicity studies have been performed.
Danish: Der er ikke udført karcinogenicitetsundersøgelser.
English: Very common (may affect more than 1 in 10 people) Influenza, cough, fever.
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) Influenza, hoste, feber.
English: You should try to take the dose at about the same time on each of the three days.
Danish: Du skal forsøge at tage dosis på ca. det samme tidspunkt på hver af de tre dage.
English: Compared to adult males, female patients and elderly patients have longer QTc intervals.
Danish: Sammenlignet med voksne mænd har kvindelige patienter og ældre patienter længere QTc-intervaller.
English: The extent of interactions in the paediatric population is not known.
Danish: Omfanget af interaktioner i den pædiatriske population er ukendt.
English: • is taking certain other medicines which could cause possible metabolic interactions.
Danish: • tager visse former for anden medicin, som kan give mulige metaboliske interaktioner.
English: Contact your doctor urgently to obtain an alternative treatment for malaria.
Danish: Kontakt omgående lægen for at få en alternative behandling mod malaria.
English: Tell your doctor immediately, or go immediately to the emergency department of your nearest hospital, taking this leaflet with you.
Danish: Fortæl det straks til din læge eller tag straks på skadestuen på dit nærmeste hospital, og medbring denne indlægsseddel.
English: No data are available for these paediatric subsets.
Danish: Der foreligger ingen data for disse pædiatriske undergrupper.
English: Eurartesim with food and drink
Danish: Brug af Eurartesim sammen med mad og drikke