FrancophonIA/ELRC3.0 huggingface dataset:
English: Other side effects can occur at any time during treatment with Herceptin, not just related to an infusion.
Danish: Andre bivirkninger kan indtræffe på ethvert tidspunkt under behandlingen med Herceptin, og som ikke kun er relateret til en infusion.
English: Reproductive toxicology studies with rHuPH20 revealed embryofetal toxicity in mice at high systemic exposure, but did not show teratogenic potential.
Danish: Reproduktive toksikologistudier med rHuPH20 viste embryo-føtal-toksicitet i mus ved høj systemisk eksponering, men viste ikke teratogent potentiale.
English: If the patient misses a dose of Herceptin subcutaneous formulation, it is recommended to administer the next 600 mg dose (i.e. the missed dose) as soon as possible.
Danish: Hvis patienten undlader en dosis af Herceptin subkutan formulering, anbefales det at administrere den næste dosis på 600 mg (dvs. den glemte dosis) så hurtigt som muligt.
English: Overexpression of HER2 is observed in 20 %-30 % of primary breast cancers.
Danish: Der er observeret overekspression af HER2 i 20-30 % af primær brystkræft.
English: Treatment with Herceptin alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Danish: Behandling med Herceptin alene eller sammen med et taxan kan påvirke hjertet, især hvis du tidligere har fået antracykliner (taxaner og antracykliner er to andre slags lægemidler, der anvendes til at behandle kræft).
English: Herceptin was administered weekly with chemotherapy and 3 weekly thereafter for a total of 52 weeks.
Danish: Herceptin blev administreret ugentligt med kemoterapi og derefter hver 3. uge i ialt 52 uger.
English: Once removed from the refrigerator Herceptin subcutaneous formulation must be administered within 6 hours and should not be kept above 30°C.
Danish: Når Herceptin subkutan formulering tages ud af køleskabet, skal lægemidlet administreres inden for 6 timer og bør ikke opbevares ved temperaturer over 30 °C.
English: All but one patient who reported severe hypertension had a history of hypertension before they entered the study.
Danish: Alle på nær en patient, der rapporterede svær hypertension havde en anamnese med hypertension før de indgik i studiet.
English: After transfer of the solution to the syringe, it is recommended to replace the transfer needle by a syringe closing cap to avoid drying of the solution in the needle and not compromise the quality of the medicinal product.
Danish: Efter overførsel af opløsningen til sprøjten anbefales det, at udskifte nålen, der blev brugt til overførslen med en lukningshætte til sprøjten for at undgå udtørring af opløsningen i nålen og for ikke at kompromittere lægemidlets kvalitet.
English: Results were consistent with the known safety profile for Herceptin intravenous and Herceptin subcutaneous formulations.
Danish: Resultaterne var i overensstemmelse med den kendte sikkerhedsprofil for Herceptin intravenøs og Herceptin subkutan formuleringer.
English: The injection site should be alternated between the left and right thigh.
Danish: Injektionsstedet skal skiftes mellem venstre og højre lår.
English: t1/2 range from Cmax,ss to
Danish: t1/2-interval fra Cmax,ss til
English: Hazard Ratio versus Observation *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52 % of patients from the observation arm to Herceptin) *** There is a discrepancy in the overall sample size due to a small number of patients who were randomized after the cut-off date for the 12-month median follow-up analysis
Danish: Hazard ratio versus observation *Co-primære endepunkt for sygdomsfri overlevelse på 1 år versus observation overholdt de prædefinerede statistiske grænser ** Endelig analyse (inkluderende overgang af 52 % af patienterne fra observations-armen til Herceptin) ***Der er diskrepans i den samlede prøvestørrelse grundet et lille antal patienter, der blev randomiseret efter skæringsdatoen for analysen for 12 måneders median opfølgning.
English: Based on the observed data in study BO22227, steady state with the intravenous formulation was reached at cycle 8.
Danish: Baseret på de observerede data i studie BO22227 var steady-state opnået ved serie 8 med den intravenøse formulering.
English: In this section, the following categories of frequency have been used: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
Danish: I dette punkt er følgende kategorier for hyppighed blevet anvendt: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til
English: For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Herceptin is given every 3 weeks.
Danish: Ved tidlig brystkræft, metastatisk brystkræft og metastatisk mavekræft gives Herceptin hver 3. uge.
English: The 13week study was performed to confirm that the change in route of administration and the use of the novel excipient recombinant human hyaluronidase (rHuPH20) did not have an effect on the Herceptin safety characteristics.
Danish: 13ugers studiet blev udført for at bekræfte at ændring i administrationsvejen og anvendelsen af det nye hjælpestof rekombinant human hyalorunidase (rHuPH20) ikke påvirkede Herceptins sikkerhedsprofil.
English: The reconstituted Herceptin results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Danish: Det rekonstituerede Herceptin resulterer i en farveløs til svagt gul, klar opløsning, som hovedsaglig skal være fri for synlige partikler.
English: In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50 % of tumour cells.
Danish: Generelt anses CISH for at være positiv, hvis der er mere end 5 kopier af HER2-genet per cellekerne i mere end 50 % af tumorcellerne.
English: FP + H: Fluoropyrimidine/cisplatin + Herceptin FP: Fluoropyrimidine/cisplatin a Odds ratio
Danish: FP+H: Fluoropyrimidin/cisplatin + Herceptin FP: Fluoropyrimidin/cisplatin a Sandsynslighedsratio
English: Herceptin should not be mixed or diluted with other products.
Danish: Herceptin må ikke blandes eller fortyndes med andre produkter.
English: At the time of the analysis a total of 349 randomized patients had died: 182 patients (62.8 %) in the control arm and 167 patients (56.8 %) in the treatment arm.
Danish: På det tidspunkt, analysen blev foretaget, var i alt 349 randomiserede patienter døde: 182 patienter (62,8 %) i kontrolarmen og 167 patienter (56,8 %) i behandlingsarmen.
English: The safety of continuation or resumption of Herceptin in patients who experience cardiac dysfunction has not been prospectively studied.
Danish: Sikkerheden ved fortsættelse eller genoptagelse af Herceptin-behandling hos patienter, som oplever kardiel dysfunktion, er ikke undersøgt prospektivt.
English: The most frequent severe reaction was drug hypersensitivity.
Danish: Den hyppigste svære bivirkning var overfølsomhed over for lægemidlet.
English: Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without Herceptin.
Danish: Patienter, som tidligere har fået antracyklinbaseret adjuverende kemoterapi, blev behandlet med paclitaxel (175 mg/m2 infunderet over 3 timer) med eller uden Herceptin.
English: Patients treated with Herceptin are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction.
Danish: Patienter, som behandles med Herceptin, har en øget risiko for at udvikle kongestiv hjerteinsufficiens (New York Heart Association [NYHA] klasse II-IV) eller asymptomatisk kardiel dysfunktion.
English: From a microbiological point of view, the reconstituted solution and Herceptin infusion solution should be used immediately.
Danish: Set fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning og infusionsvæsken med Herceptin anvendes med det samme.
English: The hypodermic injection needle must be attached to the syringe immediately prior to administration followed by volume adjustment to 5 mL.
Danish: Den subkutane kanyle skal sættes på sprøjten umiddelbart inden administration efterfulgt af volumenjustering til 5 ml.
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Danish: Resultaterne af disse simuleringer indikerer, at mindst 95 % af patienterne vil nå koncentrationer <1 mikrogram/ml (ca. 3 % af den populationsforudsagte Cmin,ss, eller omkring 97 % udvaskning) i løbet af 7 måneder.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions.
Danish: Hvis produktet ikke anvendes med det samme, er opbevaringstiderne og opbevaringsbetingelserne inden ibrugtagen brugerens ansvar og vil normalt ikke overstige 24 timer ved 2 °C - 8 °C, medmindre rekonstituering og fortynding har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: Single doses of up to 960 mg of Herceptin subcutaneous formulation have been administered with no reported untoward effects.
Danish: Enkeltdoser af Herceptin subkutan formulering på op til 960 mg er blevet administreret uden rapportering af negative påvirkninger.
English: No. patients with event (%)
Danish: Antal patienter med en hændelse (%)
English: The recommended dose for Herceptin subcutaneous formulation is 600 mg irrespective of the patient's body weight.
Danish: Den anbefalede dosis af Herceptin subkutan formulering er 600 mg uafhængigt af patientens kropsvægt.
English: In addition, comparison of two years of Herceptin treatment versus one year of Herceptin treatment was performed.
Danish: Derudover blev en sammenligning af 2-års Herceptin-behandling versus 1-års Herceptin-behandling udført.
English: Linear clearance was 0.111 L/day and the central compartment volume (Vc) was 2.91 L. The Michaelis-Menten parameter values were 11.9 mg/day and 33.9 µg/mL for Vmax and Km, respectively.
Danish: Lineær clearance var 0,111 l/dag og det centrale kompartment volumen (Vc) var 2,91 l. MichaelisMenten parameter værdierne var 11,9 mg/dag og 33,9 mikrogram/ml for henholdsvis Vmax og Km.
English: The reconstituted solution should not be frozen.
Danish: Den rekonstituerede opløsning må ikke fryses.
English: On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the Herceptin infusion.
Danish: I meget sjældne tilfælde har patienter oplevet frembrud af infusionssymptomer og pulmonale symptomer mere end 6 timer efter påbegyndelse af Herceptin-infusionen.
English: Your doctor will advise you of the risks and benefits of taking Herceptin during pregnancy.
Danish: Lægen vil rådgive dig om risiko og fordele ved at tage Herceptin under graviditet.
English: Do not use Herceptin if:
Danish: Du må ikke få Herceptin, hvis:
English: As animal reproduction studies are not always predictive of human response, Herceptin should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus.
Danish: Da reproduktionsstudier på dyr ikke altid er prædiktive for mennesker, bør Herceptin undgås under graviditet med mindre den potentielle fordel for moderen opvejer den potentielle risiko for fostret.
English: In the final population PK model, in addition to primary tumor type, body-weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab.
Danish: I den endelige populationsfarmakokinetiske model blev udover primær tumortype, kropsvægt, serum-aspartat-aminotransferase og -albumin identificeret som statistisk signifikante kovarianter med indvirkning på trastuzumabs eksponering.
English: There are no immunogenicity data available for Herceptin in gastric cancer.
Danish: Der er ikke tilgængelige immunogenicitetsdata for Herceptin ved ventrikelkræft.
English: • you suffer from breathlessness., especially if you are currently using a taxane.
Danish: • du har åndenød, særligt hvis du i øjeblikket tager et taxan.
English: As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Herceptin therapy and for 7 months after the last dose.
Danish: Da humant IgG udskilles i human mælk, og da den potentielle skade på spædbørn er ukendt, må kvinder ikke amme under behandling med Herceptin og i de første 7 måneder efter sidste dosis.
English: The final results of study BO22227 at a median follow-up exceeding 70 months were also consistent with the known safety profile for Herceptin IV and Herceptin SC, and no new safety signals were observed.
Danish: De endelige resultater af studie BO22227 ved en median opfølgningstid på mere end 70 måneder var også i overensstemmelse med den kendte sikkerhedsprofil for intravenøst Herceptin og subkutant Herceptin, og ingen nye sikkerhedssignaler blev observeret.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kun til subkutan anvendelse
English: Switching treatment between Herceptin intravenous and Herceptin subcutaneous formulation and vice versa
Danish: Skift mellem Herceptin intravenøs og Herceptin subkutan formulering og omvendt
English: The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1 % versus 4.6 % in the 1-year treatment arm).
Danish: Hyppigheden af asymptomatisk kardiel dysfunktion var forøget i 2-års-behandlings-armen (8,1 % versus 4,6 % i 1-års-behandlings-armen).
English: • Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterized by high blood levels of potassium and phosphate, and low blood levels of calcium).
Danish: • Tumorlyse syndrom (en gruppe af metaboliske komplikationer, der sker efter behandling mod kræft, som er karakteriseret ved høje blodværdier af kalium og fosfat og lave blodværdier af kalcium).
English: Administration-related reactions/hypersensitivity
Danish: Administrationsrelaterede reaktioner/overfølsomhed
English: For instructions on reconstitution of Herceptin intravenous formulation before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af Herceptin intravenøs formulering før administration, se pkt.
English: Pharma Biotech Penzberg Nonnenwald 2
Danish: Roche Diagnostics GmbH Pharma Biotech Penzberg Nonnenwald 2
English: New injections should be given at least 2.5 cm from the old site and never into areas where the skin is red, bruised,
Danish: Nye injektioner skal gives mindst 2,5 cm fra det gamle injektionssted og må aldrig gives på arealer, hvor huden er rød, med blå mærker, følsom eller hård.
English: The difference between formulations was mainly observed during the adjuvant treatment phase (monotherapy) and was mainly due to postoperative wound infections, but also to various other infections such as respiratory tract infections, acute pyelonephritis and sepsis.
Danish: Forskellen mellem formuleringerne blev primært observeret i fasen med adjuverende behandling (monoterapi) og skyldtes hovedsageligt postoperative sårinfektioner, men også en række andre infektioner såsom luftvejsinfektioner, akut pyelonefritis og sepsis.
English: Approximately 17 % of cardiac dysfunction related events occurred after completion of Herceptin.
Danish: Ca. 17 % af de bivirkninger, der repræsenterede kardiel dysfunktion, indtraf efter afslutning af Herceptin.
English: For the comparative safety profile see section 4.8.
Danish: Angående den sammenlignelige sikkerhedsprofil se pkt.
English: Chemo + Herceptin (n=115)
Danish: Kemo + Herceptin (n=115)
English: The difference in serious adverse event rates between formulations was mainly due to infections with or without neutropenia (4.4 % versus 8.1 %) and cardiac disorders (0.7 % versus 1.7 %);
Danish: Forskellen i hyppigheden af alvorlige bivirkninger mellem formuleringerne skyldes primært infektioner med eller uden neutropeni (4,4 % versus 8,1 %) og kardielle sygdomme (0,7 % versus 1,7 %).
English: Herceptin subcutaneous formulation contains recombinant human hyaluronidase (rHuPH20), an enzyme used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously.
Danish: Herceptin subkutan formulering indeholder rekombinant humant hyalorunidase (rHuPH20), som er et enzym, der anvendes til at øge dispersion og absorption af co-administrerede lægemidler ved subkutan administration.
English: If you receive Herceptin in combination with chemotherapy, some of them may also be due to the chemotherapy.
Danish: Hvis du får Herceptin i kombination med kemoterapi, kan nogle af bivirkningerne skyldes kemoterapien.
English: Clinically significant interactions between Herceptin and the concomitant medicinal products used in clinical trials have not been observed.
Danish: Der er ikke observeret klinisk signifikante interaktioner mellem Herceptin og de andre lægemidler, der blev anvendt samtidigt i de kliniske studier.
English: Instructions for aseptic reconstitution:
Danish: Instruktioner for aseptisk rekonstituering:
English: Pain in extremity
Danish: Smerte i ekstremiteter
English: • one is given as an infusion into a vein (intravenous infusion)
Danish: • én, der gives som en infusion i en vene (intravenøs infusion)
English: Progression free survival was doubled in the Herceptin plus anastrozole arm compared to anastrozole (4.8 months versus 2.4 months).
Danish: Den progressionsfri overlevelse blev fordoblet i armen med Herceptin plus anastrozol sammenlignet med anastrozol (4,8 måneder versus 2,4 måneder).
English: With Herceptin subcutaneous formulation, concentrations were approximately at steady-state following Cycle 7 dose (pre-dose Cycle 8) with small increase in concentration (<15%) up to cycle 13.
Danish: Med Herceptin subkutan formulering var koncentrationerne omtrent på steady state efter serie 7 (før dosis ved serie 8) med en lille stigning i koncentratioenen (< 15 %) indtil serie 13.
English: Some adverse events / reactions were reported with a higher frequency for the subcutaneous formulation:
Danish: Nogle bivirkninger blev rapporteret med en større hyppighed ved den subkutane formulering:
English: In the pivotal trial of docetaxel (100 mg/m2 infused over 1 hour) with or without Herceptin, 60 % of the patients had received prior anthracycline-based adjuvant chemotherapy.
Danish: I det pivotale studie med docetaxel (100 mg/m2 infunderet over 1 time) med eller uden Herceptin, havde 60 % af patienterne tidligere fået antracyklinbaseret adjuverende kemoterapi.
English: This translates into an absolute benefit in terms of an 8 year disease free survival rate of 6.4 percentage points in favour of 1 year Herceptin treatment.
Danish: Dette overføres til en absolut gavnlig effekt udtrykt i en 8 års sygdomsfri overlevelsesrate på 6,4 procentpoint til fordel for 1 års Herceptin-behandling.
English: Herceptin should be carefully handled during reconstitution.
Danish: Herceptin skal behandles forsigtigt under rekonstitueringen.
English: Administration in combination with an aromatase inhibitor In the pivotal trial (BO16216) Herceptin and anastrozole were administered from day 1.
Danish: Administration i kombination med en aromatasehæmmer I det pivotale studie (BO16216) blev Herceptin og anastrozol administreret fra dag 1.
English: Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of Herceptin (see section 4.4) and have been associated with a fatal outcome.
Danish: Alvorlige anafylaktiske reaktioner, som kræver øjeblikkelig yderligere intervention, kan forekomme normalt under enten den første eller anden infusion af Herceptin (se pkt 4.4) og er blevet forbundet med letal udgang.
English: The recommended dose is 600 mg. Herceptin is given as a subcutaneous injection (under the skin) over 2 to 5 minutes every three weeks.
Danish: Den anbefalede dosis er 600 mg. Herceptin gives som en subkutan injektion (under huden) i løbet af 2-5 minutter hver tredje uge.
English: More patients experienced at least one grade 3 or 4 adverse event in the 2-year treatment arm (20.4 %) compared with the 1-year treatment arm (16.3 %).
Danish: Flere patienter oplevede mindst en grad 3 eller 4 bivirkning i 2-års-behandlings-armen (20,4 %) sammenlignet med 1-års-behandlings-armen (16,3 %).
English: Herceptin is for single-use only.
Danish: Herceptin er kun til enkeltdosisbrug.
English: Herceptin has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone.
Danish: Herceptin er blevet undersøgt i et randomiseret, åbent fase-III-studie ToGA (BO18255) i kombination med kemoterapi versus kemoterapi alene.
English: Bioavailability of trastuzumab given as the subcutaneous formulation was estimated to be 77.1%, and the first order absorption rate constant was estimated to be 0.4 day-1.
Danish: Biotilgængeligheden af trastuzumab givet som subkutan formulering blev estimeret til 77,1 % og første-ordensabsorptionshastighedskonstanten blev estimeret til 0,4 dag-1.
English: * Observed with combination therapy following anthracyclines and combined with taxanes
Danish: * Observeret ved kombinationsbehandling efter antracykliner og kombineret med taxaner.
English: Recombinant human hyaluronidase (rHuPH20) L-histidine
Danish: Rekombinant human hyalorunidase (rHuPH20) L-histidin
English: Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥50 % after the event) was evident for 71.4 % of Herceptin-treated patients.
Danish: Reversibiliteten af svær kongestiv hjerteinsufficiens (defineret som en sekvens på mindst to på hinanden følgende LVEF-værdier ≥50 % efter hændelsen) var evident hos 71,4 % af de Herceptin behandlede patienter.
English: Intravenous formulation
Danish: Intravenøs formulering
English: • You should use effective contraception during treatment with Herceptin and for at least 7 months after treatment has ended.
Danish: • Du skal bruge effektiv prævention under behandlingen med Herceptin og i mindst 7 måneder efter, at behandlingen er stoppet.
English: The addition of Herceptin to paclitaxel chemotherapy also resulted in a 37 % decrease in the risk of death.
Danish: Tilføjelse af Herceptin til paclitaxel-kemoterapi resulterede også i en 37 % nedsættelse af risikoen for død.
English: The majority of patients with cardiac symptoms and evidence of a clinical benefit of Herceptin treatment continued on therapy without additional clinical cardiac events.
Danish: Størstedelen af patienterne med kardielle symptomer og evidens på en klinisk fordel af Herceptin-behandling fortsatte behandlingen med Herceptin uden yderligere kliniske kardielle hændelser.
English: Subcutaneous formulation
Danish: Subkutan formulering
English: Read the package leaflet before use.
Danish: Læs indlægssedlen inden brug
English: (vs. AC→D) (BCIRG 006)
Danish: (versus AC→D) (BCIRG 006)
English: More patients treated with Herceptin and paclitaxel progressed in the central nervous system than those treated with paclitaxel alone (12.6 % versus 6.5 %; p=0.377).
Danish: Flere patienter, som blev behandlet med Herceptin og paclitaxel, progredierede i centralnervesystemet sammenlignet med dem, som blev behandlet med paclitaxel alene (12,6 % versus 6,5 %, p = 0,377).
English: The mean Cmax was expectedly lower in the Herceptin subcutaneous formulation (149 μg/mL) than in the intravenous arm (end of infusion value: 221 μg/mL).
Danish: Gennemsnittet af Cmax var som forventet lavere ved Herceptin subkutan formulering (149 mikrogram/ml) end i den intravenøse arm (værdi ved infusionsafslutning: 221 mikrogram/ml).