FrancophonIA/ELRC3.0 huggingface dataset:
English: If not used immediately storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 25°C and 24 hours at 2-8°C following dilution in a glucose 5% intravenous infusion bag, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis infusionsvæsken ikke anvendes straks, er opbevaringstid og -forhold før anvendelse brugerens eget ansvar og bør normalt ikke overskride 12 timer ved 25 °C og 24 timer ved 2-8 °C efter fortynding i en intravenøs infusionspose med glucose 5 %, medmindre rekonstitution og fortynding er foretaget under kontrollerede og validerede aseptiske forhold.
English: No effect of oritavancin on the in vivo coagulation system was observed in nonclinical and clinical studies.
Danish: Oritavancin havde ingen indvirkning på koagulationssystemet i ikke-kliniske og kliniske in vivostudier.
English: Dizziness may occur and this may have an effect on driving and use of machines (see section 4.8).
Danish: Der kan opstå svimmelhed, og dette kan påvirke evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: These effects result from oritavancin binding to and preventing the action of the phospholipid reagents which activate coagulation in commonly used laboratory coagulation tests.
Danish: Disse virkninger skyldes, at oritavancin binder til og forhindrer virkningen af de fosfolipidreagenser, der aktiverer koagulationen i almindeligt anvendte koagulationsanalyser på laboratoriet.
English: Liver function test abnormal (Alanine aminotransferase increased, Aspartate aminotransferase increased)
Danish: Abnorme leverfunktionsprøver (forhøjet ALAT, forhøjet ASAT)
English: • 40 mL of water for injections (WFI) should be added using a sterile syringe to reconstitute each vial to provide a 10 mg/mL solution per vial.
Danish: • 40 ml vand til injektionsvæsker skal tilsættes med en steril sprøjte for at rekonstituere hvert hætteglas og få et koncentrat på 10 mg/ml pr. hætteglas.
English: Other medicines and Orbactiv
Danish: Brug af anden medicin sammen med Orbactiv
English: Contains 400 mg oritavancin.
Danish: Indeholder 400 mg oritavancin
English: A study to assess the drug-drug interaction effect of a single 1,200mg dose of oritavancin on the pharmacokinetics of S-warfarin following a single dose was conducted in 36 healthy subjects.
Danish: Et studie til vurdering af lægemiddelinteraktion mellem en enkeltdosis oritavancin på 1.200 mg og en enkeltdosis warfarin, hvad angår S-warfarins farmakokinetik, blev gennemført hos 36 raske forsøgspersoner.
English: Orbactiv may interfere with laboratory tests or self-test that measure how well your blood is clotting (INR) and may cause a false reading up to 12 hours after the infusion.
Danish: Orbactiv kan påvirke laboratorietests eller hjemmetests til måling af, hvor godt dit blod størkner (INR), og derved medføre forkerte resultater op til 12 timer efter indgivelse.
English: Orbactiv may interfere with laboratory tests that measure how well your blood is clotting and may cause a false reading.
Danish: Orbactiv kan påvirke laboratorieprøver, der måler, hvor godt dit blod størkner (koagulerer), og kan give et falsk resultat af prøven.
English: Oritavancin binds to and prevents the action of the phospholipid reagents which activate coagulation in commonly used laboratory coagulation tests.
Danish: Oritavancin binder til og forhindrer virkningen af de fosfolipidreagenser, der aktiverer koagulationen i almindeligt anvendte koagulationsanalyser på laboratoriet.
English: In Phase 3 ABSSSI clinical trials, more cases of osteomyelitis were reported in the oritavancin-treated arm than in the vancomycin-treated arm (see section 4.8).
Danish: I kliniske fase 3 ABSSSI-studier blev der indberettet flere tilfælde af osteomyelitis i oritavancin-armen end i vancomycin-armen (se pkt.
English: Three Orbactiv 400 mg vials need to be reconstituted and diluted to prepare a single once-only 1,200 mg IV dose.
Danish: 3 Orbactiv 400 mg hætteglas skal rekonstitueres og fortyndes for at klargøre en 1.200 mg i.v.-dosis til engangsbrug.
English: A screening drug-drug interaction study was conducted in healthy volunteers (n=16) evaluating the concomitant administration of a single 1,200 mg dose of oritavancin with probe substrates for several CYP450 enzymes.
Danish: Der blev gennemført et screeningsstudie af interaktion mellem lægemidler hos raske frivillige (n=16) til vurdering af samtidig administration af en enkelt dosis oritavancin 1.200 mg med probesubstrater for flere CYP-enzymer.
English: Your doctor will monitor you in case this happens and treat you if necessary.
Danish: Din læge vil følge dig, hvis dette sker, og behandle dig efter behov.
English: • Withdraw 40 mL from each of the three reconstituted vials and add to D5W intravenous bag to bring the bag volume to 1,000 mL.
Danish: • Træk 40 ml fra hver af de 3 rekonstituerede hætteglas og sæt det til i.v.-posen med glucose 5 %, så posens volumen er på 1.000 ml.
English: Up to 120 hours
Danish: Op til 120 timer
English: If reactions do occur, stopping or slowing the infusion may result in cessation of these symptoms (see section 4.8).
Danish: Hvis der opstår reaktioner, kan disse symptomer ophøre ved at standse infusionen eller sætte infusionshastigheden ned (se pkt.
English: Antibacterial-associated colitis and pseudomembranous colitis have been reported for oritavancin and may range in severity from mild to life threatening diarrhoea.
Danish: Der er indberettet antibakteriel-associeret kolitis og pseudomembranøs kolitis af varierende sværhedsgrad fra let til livstruende diarré i forbindelse med oritavancin.
English: Activated clotting time (ACT)
Danish: Aktiveret koagulationstid (ACT)
English: If newly emergent abscesses occur, appropriate measures should be taken.
Danish: Ved debuterende abscesser skal der træffes passende foranstaltninger.
English: Extramedullary haematopoiesis in the spleen was observed in rats.
Danish: Der blev observeret ekstramedullær hæmatopoiese i milten hos rotter.
English: How you will be given Orbactiv
Danish: Sådan får du Orbactiv
English: patients is 138 (23) μg/ml and 2,800 (28.6) μg•h/mL respectively.
Danish: og AUC0-∞ hos patienter med akutte bakterielle infektioner, som fik en enkelt 1.200 mg dosis, er hhv. 138 (23) μg/ml og 2.800 (28,6) μg•t/ml.
English: Silica clot time (SCT)
Danish: Silica-aktiveret koagulationstid (SCT)
English: Up to 12 hours
Danish: Op til 12 timer
English: No dosage adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class B) (see section 5.2).
Danish: Dosisjustering er ikke nødvendig til patienter med let til moderat nedsat leverfunktion (Child-Pughklasse B) (se pkt.
English: The mean terminal elimination plasma half-life of oritavancin is 245 hours (14.9% CV) based on population PK analysis of ABSSSI patients receiving a single 1,200 mg dose.
Danish: Oritavancins gennemsnitlige terminale eliminationshalveringstid i plasma er 245 timer (14,9 % CV) baseret på en populations-PK-analyse hos patienter med akutte bakterielle hudinfektioner, som fik en enkelt dosis på 1.200 mg. Populationens gennemsnitlige totale clearance er beregnet til 0,445 l/t (27,2 % CV).
English: Up to 72 hours
Danish: Op til 72 timer
English: Orbactiv is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1).
Danish: Orbactiv er indiceret til behandling af akutte bakterielle infektioner i hud og hudstrukturer (ABSSSI, acute bacterial skin and skin structure infections) hos voksne (se pkt.
English: Oritavancin is active against Gram positive bacteria only (see section 5.1).
Danish: Oritavancin virker kun på grampositive bakterier (se pkt.
English: Frequency of adverse reactions by system organ class
Danish: Tabel 2: Bivirkningshyppighed efter organsystemklasse
English: There were no relevant changes in pharmacokinetics of oritavancin in subjects with moderate hepatic impairment.
Danish: Der var ingen relevante ændringer i oritavancins farmakokinetik hos patienter med moderat nedsat leverfunktion.
English: Bronchospasm, wheezing
Danish: Bronkospasme, hvæsen
English: Up to 24 hours
Danish: Op til 24 timer
English: Animal studies have revealed no evidence of impaired fertility due to oritavancin at the highest concentrations administered, however, there is no data on the effects of oritavancin on human fertility.
Danish: Dyrestudier har ikke vist evidens for nedsat fertilitet på grund af oritavancin ved de højeste administrerede koncentrationer.
English: • Withdraw and discard 120 mL from a 1,000 mL D5W intravenous bag.
Danish: • Træk 120 ml op fra en 1.000 ml i.v.-pose og kassér det.
English: Interference with assay for coagulation tests
Danish: Interferens med koagulationsanalyser
English: Dosage adjustment of oritavancin is not needed in patients with mild or moderate renal impairment.
Danish: Justering af oritavancindosis er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion.
English: After reconstitution, 1 ml of the solution contains 10 mg oritavancin.
Danish: Efter rekonstitution indeholder 1 ml koncentrat 10 mg oritavancin.
English: The reconstituted solution should be further diluted in glucose 50 mg/ml (5%) intravenous infusion bag immediately.
Danish: Det rekonstituerede koncentrat skal straks fortyndes yderligere i en i.v.-infusionspose med glucose 50 mg/ml (5 %).
English: - If you have any further questions, ask your doctor or nurse.
Danish: - Spørg lægen eller sygeplejersken, hvis der er mere, du vil vide.
English: If osteomyelitis is suspected or diagnosed, appropriate alternative antibacterial therapy should be instituted.
Danish: Alternativ antibakteriel behandling skal iværksættes ved mistænkt eller diagnosticeret osteomyelitis.
English: These reactions were associated with mortality at lower dosages in male than in female rats in single dose studies; however, the same gender-related differences were not observed in other species.
Danish: Disse reaktioner var forbundet med mortalitet ved lavere doser hos hanrotter end hos hunrotter i studier med en enkelt dosis.
English: Orbactiv 400 mg powder for concentrate oritavancin
Danish: Orbactiv 400 mg pulver til koncentrat oritavancin
English: • Shortness of breath;
Danish: • Hvæsende vejrtrækning
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship
Danish: Farmakokinetiske/farmakodynamiske forhold
English: Single-use 50 ml Type 1 glass vials with rubber stoppers and aluminium flip off cap. 3 individual vials are packaged in a carton.
Danish: 50 ml type 1-hætteglas af glas til engangsbrug med gummiprop og afrivningshætte af aluminium.
English: Dosage adjustment of oritavancin is not needed in patients with mild and moderate hepatic impairment.
Danish: Justering af oritavancindosis er ikke nødvendig hos patienter med let og moderat nedsat leverfunktion.
English: Powder for concentrate for solution for infusion 3 vials
Danish: Pulver til koncentrat til infusionsvæske, opløsning 3 hætteglas
English: Package leaflet: Information for the patient Orbactiv 400 mg powder for concentrate for solution for infusion oritavancin
Danish: Indlægsseddel: Information til patienten Orbactiv 400 mg pulver til koncentrat til infusionsvæske, opløsning oritavancin
English: Urticaria, rash, pruritis
Danish: Urticaria, hududslæt, pruritus
English: For patients who require aPTT monitoring within 120 hours of oritavancin dosing, a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT monitoring may be considered.
Danish: Det kan overvejes at anvende en ikke-fosfolipid-afhængig koagulationstest, som f.eks. en faktor Xa-analyse (kromogen) eller en alternativ antikoagulans, der ikke kræver aPTT-monitorering, til patienter, hvor aPTT-monitorering er nødvendig inden for 120 timer efter oritavancin-dosering.
English: Sodium chloride solution should not be used for dilution (see section 6.2).
Danish: Brug ikke natriumchloridinfusionsvæske til fortynding (se pkt.
English: After reconstitution and dilution, 1 ml solution for infusion contains 1.2 mg oritavancin.
Danish: Efter rekonstitution og fortynding indeholder 1 ml infusionsvæske, opløsning, 1,2 mg oritavancin
English: Oritavancin has been shown to interfere with certain laboratory coagulation tests (see sections 4.3 and 4.5).
Danish: Det er vist, at oritavancin påvirker visse koagulationsanalyser i laboratoriet (se pkt.
English: After dilution, 1 ml of the solution for infusion contains 1.2 mg oritavancin.
Danish: Efter fortynding indeholder 1 ml infusionsvæske 1,2 mg oritavancin.
English: The pharmacokinetics of oritavancin in patients with severe renal impairment has not been evaluated.
Danish: Oritavancins farmakokinetik er ikke blevet vurderet hos patienter med svært nedsat leverfunktion.
English: Your doctor will treat you as necessary.
Danish: Din læge vil behandle dig i relevant omfang.
English: • To avoid excessive foaming, it is recommended that WFI should be added carefully, along the walls of the vials.
Danish: • Det anbefales at tilsætte vand til injektionsvæsker forsigtigt langs hætteglassets væg for at undgå kraftig skumdannelse.
English: No dosage adjustment is needed in patients with mild or moderate renal impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig til patienter med let eller moderat nedsat nyrefunktion (se pkt.
English: Beta-haemolytic streptococci Groups A, B, C, G 0.25 Viridans group streptococci (S. anginosus group only)
Danish: Beta-hæmolytiske streptokokker gruppe A, B, C, G
English: Drug-laboratory test interactions (see sections 4.3 and 4.4)
Danish: Interaktioner mellem lægemiddel og laboratorieprøver (se pkt.
English: • Muscle pain;
Danish: • Muskelsmerter
English: • Increased blood bilirubin levels ;
Danish: • Forhøjet niveau af bilirubin (rødt galdefarvestof) i blodet
English: The reconstituted solution should be further diluted in glucose 5% intravenous infusion bag immediately.
Danish: Den rekonstituerede opløsning bør straks fortyndes yderligere i en 5 mg/ml i.v.-infusionspose med glucose 5 %.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Danish: Må ikke opbevares ved temperaturer over 25° C. Opbevaringsforhold efter rekonstitution og fortynding af lægemidlet, se pkt.
English: The pharmacokinetics of oritavancin was examined in the single dose Phase 3 ABSSSI studies in patients with normal renal function, CrCL ≥90 mL/min (n=213), mild renal impairment, CrCL 60-89 mL/min (n=59), moderate renal impairment, CrCL 30-59 mL/min (n=22), and severe renal impairment CrCL <30 mL/min (n=3).
Danish: Oritavancins farmakokinetik efter en enkelt dosis blev undersøgt i ABSSSI fase 3-studier hos patienter med normal nyrefunktion [CrCL ≥90 ml/min.
English: • Headache;
Danish: • Hovedpine
English: Orbactiv is intended for intravenous (IV) administration, only after reconstitution and dilution.
Danish: Orbactiv er beregnet til intravenøs (i.v.)
English: If you are given more Orbactiv than you should
Danish: Hvis du får for meget Orbactiv
English: Dilution: Three reconstituted vials are needed for dilution for administration of a single 1,200 mg intravenous infusion.
Danish: Fortynding: 3 rekonstituerede hætteglas skal fortyndes for at administrere en enkelt intravenøs infusion på 1.200 mg. Kun en i.v.-pose med glucose 5 % må bruges til fortynding.
English: • Constipation;
Danish: • Kortåndethed
English: • Beta-haemolytic streptococci of Group G
Danish: • Gruppe G betahæmolytiske streptokokker
English: Orbactiv 400 mg powder for concentrate for solution for infusion oritavancin
Danish: Orbactiv 400 mg pulver til koncentrat til infusionsvæske, opløsning oritavancin
English: Orbactiv 400 mg powder for concentrate for solution for infusion
Danish: Orbactiv 400 mg pulver til koncentrat til infusionsvæske, opløsning
English: What Orbactiv is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: • Severe rash;
Danish: • Rysten
English: Substances metabolised by cytochrome P450
Danish: Stoffer, der metaboliseres vha. CYP
English: What Orbactiv looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: • Wash your hands.
Danish: • Vask Deres hænder.
English: Steady state was achieved at week 4.
Danish: Steady state opnåedes i uge 4.
English: gender and ethnic origin had no effect.
Danish: Køn og etnisk oprindelse havde ingen effekt.
English: For this purpose the following classification has been used:
Danish: Følgende klassifikation er benyttet:
English: It is important that your hands and items you use be as clean as possible.
Danish: Det er vigtigt, at Deres hænder og de ting, De bruger, er så rene som
English: These symptoms are uncommon.
Danish: Disse symptomer er ualmindelige.
English: None of those events was serious and less than 5% were considered severe.
Danish: Ingen af bivirkningerne var alvorlige, og mindre end 5 % blev betragtet som svære.
English: These reactions were largely mild to moderate.
Danish: Reaktionerne var hovedsageligt milde til moderate.
English: • Fever or if you think that you have an infection.
Danish: • Feber eller hvis De mistænker, at De har en infektion.
English: b) Vaccinations
Danish: b) Vaccinationer
English: Tend at steady state is 25 days (range 13-35 days).
Danish: Tend ved steady state er 25 dage (periode:13-35 dage).
English: Raptiva is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
Danish: Raptiva er ikke anbefalet til brug hos børn under 18 p.g.a. mangel på data vedrørende sikkerhed og effekt.
English: Your doctor may want to examine you more closely and ask you to have blood tests.
Danish: Deres læge vil muligvis vælge at undersøge Dem nærmere og bede Dem om at få foretaget nogle blodprøver.
English: No differences in safety or efficacy were observed between elderly (≥ 65 years) patients and younger patients.
Danish: Der er ikke observeret forskelligheder i sikkerhed eller effekt mellem ældre (≥ 65 år) patienter og yngre patienter.
English: Only at 25 weeks of age was this decrease no longer significant.
Danish: Først da de var 25 uger gamle var sygdommen ikke længere signifikant..
English: Use in the elderly (≥ 65 years)
Danish: Ældre (≥ 65 år)
English: Over 600 patients have been treated for more than 1 year including 166 patients treated for more than 2 years and up to 3 years.
Danish: Mere end 600 patienter er behandlet i mere end 1 år hvoraf 166 patienter behandlet i mere end 2 år og op til 3 år.
English: EXP Use immediately after reconstitution.
Danish: EXP Anvendes straks efter opløsning.
English: The duration of therapy is 12 weeks.
Danish: Behandlingen varer 12 uger.
English: Take as much time as you need to inject all the solution.
Danish: Tag al den tid, De behøver til at indsprøjte al opløsningen.
English: Generally reconstitution takes less than 5 minutes.
Danish: Blandingsprocessen tager almindeligvis mindre end 5 minutter.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Danish: For yderligere oplysninger om dette lægemiddel bedes henvendelse rettet til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Your doctor will tell you how much you should inject.
Danish: Deres læge vil informere Dem om, hvor meget De skal indsprøjte.
English: You are now ready to select and prepare your injection site.
Danish: • De er nu klar til at vælge og forberede et injektionssted.
English: Please contact your doctor if you forget to take 2 or more doses of Raptiva.
Danish: Kontakt Deres læge, hvis De glemmer at tage flere end to doser Raptiva.
English: He/she will calculate the correct dosage based on your new weight.
Danish: Han vil da udregne den korrekte dosis i forhold til Deres nye vægt.
English: The dosage and administration schedule in the elderly should be the same as for adults (see also section 4.4).
Danish: Dosis- og administrationsskemaet for ældre patienter bør være det samme som for voksne patienter (se også afsnit 4.4).
English: Long-term exposure:
Danish: Langtidsbehandling:
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Danish: Patienter bør også rådes til at informere deres ægtefælle og eller pårørende om deres behandling, da disse ville kunne blive opmærksom på symptomer, som patienten selv ikke er klar over.
English: Cytochrome P450 enzymes as well as conjugation reactions are not involved in the metabolism of
Danish: Cytochrom P450-enzymer samt konjugationsreaktioner er ikke involveret i metabolismen af
English: Generally patients with facial paralysis recover within a few weeks without any specific treatment.
Danish: Normalt vil patienter med facialisparese komme sig indenfor få uger uden nogen specifik behandling.
English: It is not known whether Raptiva can cause harm to your baby if you are pregnant or whether it can affect your ability to become pregnant.
Danish: Det vides ikke, om Raptiva kan skade Deres barn, under graviditet, eller hvorvidt midlet kan påvirke Deres evne til at blive gravid.
English: The same results were confirmed in patients that were unsuitable for other systemic therapies (see Table 1 below).
Danish: De samme resultat blev bekræftet hos patienter, der var uegnet til andre systemiske behandliger (se tabel 1 nedenfor).
English: As there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Danish: Da der generelt er en højere forekomst af infektioner hos den ældre population, bør der udvises forsigtighed i behandlingen af ældre patienter.
English: (See “Take special care with Raptiva”)
Danish: (Se "Vær særlig forsigtig med at anvende Raptiva")
English: Your doctor or nurse will have already advised you where to inject.
Danish: Deres læge eller sygeplejerske vil allerede have fortalt Dem, hvor De skal indsprøjte opløsningen.
English: This leaflet was last approved on
Danish: Denne indlægsseddel blev senest godkendt
English: 1 DNA Way, South San Francisco, CA 94080-4990
Danish: 1 DNA Way, South San Francisco, CA 94080-4990 USA
English: Headache was the most frequent of the flu-like symptoms.
Danish: Hovedpine var det hyppigste af de influenza-lignende symptomer.
English: It may be necessary to discontinue Raptiva treatment 8 weeks before a vaccination.
Danish: Det kan være nødvendig at stoppe behandlingen med Raptiva 8 uger før en vaccination.
English: Monoclonal antibodies are proteins that recognise and bind to other specific proteins of the human body.
Danish: Monoklonale antistoffer er proteiner, som genkender og binder sig til andre bestemte proteiner i kroppen.
English: - If you have active tuberculosis or other severe infections.
Danish: - Hvis De har aktiv tuberkulose eller andre alvorlige infektioner.
English: - Some patients had reactions including headache, fever, nausea and vomiting within two days of each of the first two injections.
Danish: - Nogle patienter har oplevet reaktioner som f.eks. hovedpine, feber, kvalme og opkastninger to dage efter hver af de første to injektioner.
English: - You might get infections more easily.
Danish: - De kan måske blive mere modtagelig over for infektioner.
English: Systemic therapies are medicines taken orally or administered by injection and thus will be present in and affect the whole body.
Danish: Systemiske lægemidler er lægemidler, der indtages peroralt eller administreres ved hjælp af injektioner og derfor forekommer det i og påvirker hele kroppen.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er brugeren selv ansvarlig for opløsningens opbevaringstider og -forhold inden brug, som normal ikke er mere end 24 timer ved 2°C til 8°C, medmindre blanding har fundet sted under kontrollerede og validerede aseptiske forhold.