FrancophonIA/ELRC3.0 huggingface dataset:
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Haematological as well as other toxicity may require dose reductions or delays.
Danish: Hæmatologisk toksicitet såvel som anden toksicitet kan kræve reduktioner eller udskydelse af doseringen.
English: Tell your doctor or nurse straight away if any medicine leaks from the drip (infusion) onto your skin.
Danish: Fortæl straks lægen eller sundhedspersonalet, hvis der lækker medicin fra droppet (infusionen) ned på din hud.
English: • low blood pressure, feeling unwell
Danish: • lavt blodtryk, følelse af utilpashed
English: • Pregnant staff should be excluded from handling the medicinal product.
Danish: • Gravide blandt personalet må ikke håndtere lægemidlet.
English: It is given as a drip (infusion) into a vein.
Danish: Det indgives som et drop (infusion) i en blodåre.
English: • change in how often you pass water (urine), pain on passing water or blood in your urine
Danish: • ændring i hvor ofte du skal tisse, smertefuld vandladning eller blod i urinen
English: If LVEF has decreased substantially from baseline e.g. by > 20 points to a final value > 50% or by > 10 points to a final value of < 50%, the benefit of continued therapy must be carefully evaluated against the risk of producing irreversible cardiac damage.
Danish: Hvis LVEF er betydeligt reduceret i forhold til baseline, f.eks. med >20 points til en slutværdi på >50 % eller med >10 points til en slutværdi på <50 %, skal fordelen ved en fortsat behandling vurderes nøje i forhold til risikoen for at fremkalde irreversibel beskadigelse af hjertet.
English: None 2 1000 - Less than 1500 50,000 - Less than 75,000 None 25,000 - Less than 50,000 Wait until ANC 1500 or
Danish: Ingen 2 1000-under 1500 50.000-under 75.000 Ingen 25.000-under 50.000 Vent til ANC 1500 eller mere og/eller trombocytter 100.000 eller
English: However, the most definitive test for anthracycline myocardial injury, i.e., endomyocardial biopsy, should be considered.
Danish: Imidlertid skal den mest definitive test for anthracyclinbeskadigelse af myokardiet, dvs. endomyokardiel biopsi, overvejes.
English: (Please note that whilst the control settings on the water bath and heat block are set to different levels the temperature of the vial contents are in the same range (55°C-60°C)).
Danish: (Bemærk, at selv om kontrolindstillingerne på vandbadet og varmeblokkene indstilles til forskellige temperaturniveauer, vil temperaturen på indholdet i hætteglassene ligge inden for det samme område (55 °C-60 °C)).
English: • Myocet liposomal should not be used during pregnancy unless clearly necessary.
Danish: • Myocet liposomal bør ikke anvendes under graviditeten, medmindre det er strengt nødvendigt.
English: Congestive heart failure due to cardiomyopathy may occur suddenly, and may also be encountered after discontinuation of therapy.
Danish: Kongestiv hjerteinsufficiens på grund af kardiomyopati kan opstå pludseligt og kan også optræde efter ophørt behandling.
English: • Shake well in the inverted position to ensure doxorubicin is fully dissolved.
Danish: • Ryst det grundigt med bunden i vejret for at sikre, at doxorubicin opløses helt.
English: Standard dose of 60 - 75mg/m2
Danish: Standarddosis på 60 - 75 mg/m2
English: If you have already had radiation therapy, this may react with Myocet liposomal.
Danish: Hvis du allerede har fået strålebehandling, kan dette reagere med Myocet liposomal.
English: • stomach pains which may be a sign of a stomach ulcer forming
Danish: • mavesmerter, som kan være tegn på udvikling af mavesår
English: Pharmaco-therapeutic group: Antineoplastic agents, anthracyclines and related substances, ATC code: L01DB01
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, anthracycliner og beslægtede stoffer, ATC-kode: L01DB01
English: The risk of toxicity rises with increasing cumulative doses of those medicinal products and is higher in individuals with a history of cardiomyopathy, or mediastinal irradiation or pre-existing cardiac disease.
Danish: Risikoen for toksicitet vokser med stigende kumulative doser af disse lægemidler og er højere hos personer med kardiomyopati i anamnesen eller mediastinal bestråling eller allerede eksisterende hjertesygdom.
English: When the 3 vials have been mixed together, your medicine contains about 108 mg sodium.
Danish: Når de 3 hætteglas er blevet blandet, indeholder din medicin cirka 108 mg natrium.
English: The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted, namely:
Danish: De normale procedurer for korrekt håndtering og bortskaffelse af kemoterapeutika skal følges, hvilket vil sige:
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before having Myocet liposomal.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller sundhedspersonalet til råds, før du får Myocet liposomal.
English: Bilirubin < ULN and raised AST
Danish: Bilirubin < ULN og forhøjet AST
English: Myocet liposomal should be considered an irritant and precautions should be taken to avoid extravasation.
Danish: Myocet liposomal bør betragtes som irritans, og der bør træffes foranstaltninger for at undgå ekstravasation.
English: It is used with another medicine called “cyclophosphamide”.
Danish: Det bruges sammen med en anden medicin, kaldet cyclophosphamid.
English: Based on limited data in patients with liver metastases, it is recommended that the initial dose of Myocet liposomal is reduced in accordance with the following table
Danish: På baggrund af begrænsede data hos patienter med levermetastaser anbefales det, at initialdosis af Myocet liposomal reduceres i overensstemmelse med nedenstående tabel:
English: • phenobarbital or phenytoin - for epilepsy
Danish: • phenobarbital eller phenytoin - mod epilepsi
English: In the clinical program, there were nine cases of accidental extravasation of Myocet liposomal, none of which were associated with severe skin damage, ulceration or necrosis.
Danish: I det kliniske program forekom der ni tilfælde af utilsigtet ekstravasation med Myocet liposomal, hvor ingen af tilfældene var forbundet med alvorlig hudbeskadigelse, ulceration eller nekrose.
English: Carefully insert a pressure-venting device equipped with a hydrophobic filter.
Danish: Indfør forsigtigt en trykudluftende anordning med hydrofobisk filter.
English: These may be signs of heart failure, uneven heart beat or a low potassium level in your blood
Danish: Disse kan være tegn på hjertesvigt, uregelmæssig puls eller et lavt kaliumindhold i dit blod
English: As for other anthracyclines and doxorubicin products, radiation recall may occur in previously irradiated fields.
Danish: Ligesom for andre anthracycliner og doxorubicinprodukter kan radiation recall dermatitis forekomme på tidligere bestrålede områder.
English: However, doxorubicin may potentiate the toxicity of other antineoplastic agents.
Danish: Doxorubicin kan imidlertid potensere toksiciteten af andre antineoplastiske midler.
English: Therefore dose modification is not required for patients with renal function impairment.
Danish: Derfor kræves der ingen dosisændring for patienter med nedsat nyrefunktion.
English: Grades ≥ 3
Danish: Grad ≥ 3
English: Abbreviations: PFS, progression-free survival; Dox, doxorubicin; Epi, epirubicin; Relative Risk, comparator taken as reference; Risk Ratio, Myocet liposomal taken as reference a
Danish: Forkortelser: PFS, progressionsfri overlevelse; Dox, doxorubicin; Epi, epirubicin; Relativ risiko, komparator taget som reference; Risikoforholdstal, Myocet liposomal taget som reference.
English: Subsequently, the Myocet liposomal infusion should be restarted in a different vein than that in which the extravasation has occurred.
Danish: Derefter bør Myocet liposomal-infusionen genstartes i en anden vene end den, hvor ekstravasationen forekom.
English: Chemical and physical in-use stability after reconstitution has been demonstrated for up to 8 hours at 25°C, and for up to 5 days at 2°C - 8
Danish: Efter rekonstitution er der påvist kemisk og fysisk stabilitet i op til 8 timer ved 25 °C og i op til 5 dage ved 2 °C-8 °C.
English: • cyclosporine - for changing your immune system.
Danish: • ciclosporin - for at ændre dit immunforsvar
English: Vial 3 - buffer
Danish: Hætteglas 3 - buffer
English: The cardiac function of the patients treated concomitantly with Myocet liposomal and trastuzumab must be appropriately monitored as described below.
Danish: Hjertefunktionen hos de patienter, der behandles med Myocet liposomal og trastuzumab samtidigt, skal kontrolleres hensigtsmæssigt som beskrevet nedenfor.
English: Modification
Danish: Modifikation
English: Stomatitis/mucositis
Danish: Stomatit/mucositis
English: Increased alkaline phosphatase
Danish: Forhøjet alkalisk fosfatase
English: Congestive cardiac failure
Danish: Kongestiv hjerteinsufficiens
English: The medicine is contained inside very small droplets of fat called “liposomes”.
Danish: Medicinen er inde i meget små fedtdråber, som kaldes liposomer.
English: • WAIT for a minimum of 10 MINUTES before using, keeping the medicine at room temperature.
Danish: • VENT MINDST 10 MINUTTER INDEN ANVENDELSE, IMENS MEDICINEN OPBEVARES VED STUETEMPERATUR.
English: Doxorubicin and other anthracyclines can cause cardiotoxicity.
Danish: Doxorubicin og andre anthracycliner kan forårsage kardiotoksicitet.
English: Wait until ANC 1500 and/or platelets 100,000 or more then redose at 50% dose reduction
Danish: Vent til ANC 1500 og/eller trombocytter 100.000 eller mere, derefter ny dosering med 50 % dosisreduktion.
English: Data from randomised controlled clinical trials show that the efficacy and cardiac safety of Myocet liposomal in this population was comparable to that observed in patients less than 65 years old.
Danish: Data fra randomiserede, kontrollerede, kliniske studier viser, at Myocet liposomals effekt og kardielle sikkerhed i denne population var sammenlignelig med det, der er observeret hos patienter, som var under 65 år gamle.
English: Concomitant treatment with other substances reported to be cardiotoxic or with cardiologically active substances (e.g. calcium antagonists) may increase the risk for cardiotoxicity.
Danish: Samtidig behandling med andre lægemidler, der er rapporteret kardiotoksiske, eller med kardiologisk aktive stoffer (f.eks. kalciumantagonister) kan øge risikoen for kardiotoksicitet.
English: Safety and efficacy of Myocet liposomal have been assessed in 61 patients with metastatic breast cancer, age 65 and over.
Danish: Myocet liposomals sikkerhed og effekt er blevet vurderet hos 61 patienter med metastaseret brystkræft i alderen 65 år og derover.
English: Myocet liposomal should not be administered to individuals with absolute neutrophil counts (ANC) lower than 1,500 cells/µl or platelets less than 100,000/µl prior to the next cycle.
Danish: Myocet liposomal bør ikke indgives til personer med absolutte neutrofiltal (ANC) på under 1.500 celler/µl eller trombocytter på under 100.000 celler/µl forud for den næste cyklus.
English: The major circulating metabolite of doxorubicin, doxorubicinol, is formed via aldo-keto-reductase.
Danish: Den vigtigste cirkulerende doxorubicin-metabolit, doxorubicinol, dannes via aldo-keto-reduktase.
English: However, no significant differences were identified in the occurrence of anaemia, thrombocytopenia and episodes of neutropenic fever.
Danish: Der blev ikke fundet signifikante forskelle i forekomsten af anæmi, trombocytopeni og episoder med neutropen feber.
English: Due to the known cytotoxic, mutagenic and embryotoxic properties of doxorubicin, Myocet liposomal should not be used during pregnancy unless clearly necessary.
Danish: På grund af de kendte cytotoksiske, mutagene og embryotoksiske egenskaber ved doxorubicin bør Myocet liposomal ikke anvendes under graviditeten, medmindre det er strengt nødvendigt.
English: Two alternative heating methods can be used : a Techne DB-3 Dri Block heater or a water bath:
Danish: Der kan anvendes to alternative opvarmningsmetoder: en Techne DB-3 Dri Block Heater eller et vandbad
English: Available pharmacokinetic data preclude conclusions regarding the relationship between plasma levels of total/free doxorubicin and its influence on the efficacy/safety of Myocet liposomal.
Danish: Tilgængelige farmakokinetiske data udelukker konklusioner vedrørende forholdet mellem plasmakoncentrationer af totalt/frit doxorubicin og dets virkning på Myocet liposomals effekt/sikkerhed.
English: There is no experience with Myocet liposomal in patients with a history of cardiovascular disease, e.g. myocardial infarction within 6 months prior to treatment.
Danish: Der er ingen erfaring med Myocet liposomal hos patienter med kardiovaskulære sygdomme i anamnesen, f.eks. myokardieinfarkt inden for 6 måneder forud for behandling.
English: As metabolism and excretion of doxorubicin occurs primarily by the hepatobiliary route, evaluation of hepatobiliary function should be performed before and during therapy with Myocet liposomal.
Danish: Da metabolisering og udskillelse af doxorubicin primært sker ad hepatobiliær vej, bør der gennemføres en vurdering af den hepatobiliære funktion før og under behandling med Myocet liposomal.
English: Heat in water bath or dry heat block
Danish: Opvarm i vandbad eller varmeblok.
English: The use of Myocet liposomal should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy.
Danish: Anvendelse af Myocet liposomal bør begrænses til afdelinger, der er specialiseret i indgivelse af cytotoksisk kemoterapi, og det bør kun indgives under overvågning af en læge, der har erfaring i anvendelse af kemoterapi.
English: Efficacy and safety of Myocet liposomal in the adjuvant treatment of breast cancer have not been determined.
Danish: Effekt og sikkerhed af Myocet liposomal ved adjuverende behandling af brystkræft er ikke bestemt.
English: Treatment of acute overdose should focus on supportive care for expected toxicity and may include hospitalisation, antibiotics, platelet and granulocyte transfusions and symptomatic treatment of mucositis.
Danish: Behandling af akut overdosering bør fokusere på understøttende behandling af forventet toksicitet og kan omfatte indlæggelse, antibiotika, trombocyt- og granulocyttransfusioner og symptomatisk behandling af mucositis.
English: • Withdraw 20 ml sodium chloride solution for injection (0.9%), (not provided in the package), and inject into each vial of doxorubicin HCl, intended for preparation.
Danish: • Træk 20 ml natriumchloridopløsning til injektion (0,9 %) op (medfølger ikke i pakken), og injicér det i hvert hætteglas med doxorubicin HCl beregnet til opblanding.
English: The clearance of total doxorubicin was 5.1 ± 4.8 l/h and the volume of distribution at steady state (Vd) was 56.6 ± 61.5 l whereas after conventional doxorubicin, clearance and Vd were 46.7 ± 9.6 l/h and 1,451 ± 258 l, respectively.
Danish: Clearance for totalt doxorubicin var 5,1 ± 4,8 l/t, og fordelingsvolumen ved steady state (Vd) var 56,6 ± 61,5 l, mens clearance og Vd efter konventionelt doxorubicin var henholdsvis 46,7 ± 9,6 l/t og 1.451 ± 258 1.
English: Neutropenic fever
Danish: Neutropen feber
English: Thus, caution should be exercised in patients with impaired cardiac function.
Danish: Der bør derfor udvises forsigtighed hos patienter med nedsat hjertefunktion.
English: Signs may include: - increased bruising - sore mouth, throat or mouth ulcers - reduced resistance to infection or fever - feeling tired or dizzy, having a lack of energy.
Danish: Tegn kan omfatte: - øget tendens til blå mærker - ondt i munden, halsen eller sår i munden - mindsket modstandsdygtighed over for infektioner eller feber - følelse af træthed eller svimmelhed, mangel på energi.
English: The reduced risk of cardiotoxicity has also been shown in a retrospective analysis in patients who had received prior adjuvant doxorubicin (log-rank P=0.001, Hazard Ratio=5.42).
Danish: Den nedsatte risiko for kardiotoksicitet er også blevet påvist i en retrospektiv analyse hos patienter, som tidligere havde fået adjuverende doxorubicin (log-rank P = 0,001; hazard ratio = 5,42).
English: Palmar-plantar erythrodysaesthesia syndrome
Danish: Palmar-plantar erytrodysæstesisyndrom
English: - Do not use this medicine if you notice that it shows evidence of discoloration, precipitation or any other particulate matter.
Danish: - Brug ikke lægemidlet, hvis der er tegn på misfarvning, udfældning eller andre partikler.
English: Acute overdose with Myocet liposomal will worsen toxic side effects.
Danish: Akut overdosering med Myocet liposomal vil forværre de toksiske bivirkninger.
English: All patients receiving Myocet liposomal should also routinely undergo ECG monitoring.
Danish: Alle patienter, der får Myocet liposomal, skal desuden have foretaget rutinemæssig EKG-kontrol.
English: The following dosage modifications are recommended during therapy and should be performed in parallel for both Myocet liposomal and cyclophosphamide.
Danish: Følgende dosismodifikationer anbefales under behandlingen og bør gennemføres parallelt for både Myocet liposomal og cyclophosphamid.
English: If you get Myocet liposomal on your skin
Danish: Hvis du får Myocet liposomal på huden
English: For intravenous use after reconstitution and dilution.
Danish: Intravenøs anvendelse efter rekonstitution og fortynding.
English: Studies of genotoxicity, carcinogenicity and reproductive toxicity of Myocet liposomal have not been performed but doxorubicin is known to be both mutagenic and carcinogenic and may cause toxicity to reproduction.
Danish: Der er ikke udført studier af genotoksicitet, karcinogenicitet og reproduktionstoksicitet med Myocet liposomal, men doxorubicin vides at være såvel mutagent som karcinogent, og det kan muligvis forårsage reproduktionstoksicitet.
English: The plasma pharmacokinetics for total doxorubicin in patients receiving Myocet liposomal shows a high degree of inter-patient variability.
Danish: Plasma-farmakokinetikken for totalt doxorubicin hos patienter, der modtager Myocet liposomal, viser en høj grad af variabilitet patienterne imellem.
English: Studies of the effect of Myocet liposomal on other substances are also lacking.
Danish: Studier af Myocet liposomals virkning på andre stoffer mangler ligeledes.
English: Nadir ANC (cells/µl)
Danish: Grad Nadir ANC (celler/µl)
English: Doxorubicin may exert its antitumour and toxic effects by a number of mechanisms including inhibition of topoisomerase II, intercalation with DNA and RNA polymerases, free radical formation and membrane binding.
Danish: Doxorubicin kan udøve sin antitumorvirkning og toksiske virkning på en række måder, herunder hæmning af topoisomerase II, interkalering med DNA- og RNA-polymeraser, dannelse af frie radikaler og membranbinding.
English: The total dose of Myocet liposomal should also take into account any previous, or concomitant, therapy with other cardiotoxic compounds, including anthracyclines and anthraquinones.
Danish: Den totale dosis Myocet liposomal bør også tilpasses eventuel tidligere eller samtidig behandling med andre kardiotoksiske præparater, inklusive anthracycliner og anthraquinoner.
English: Redness and pain on the hands and feet
Danish: • rødme og smerter på hænder og fødder.
English: These methods should also be applied routinely during Myocet liposomal treatment.
Danish: Disse metoder bør også anvendes rutinemæssigt under behandlingen med Myocet liposomal.
English: Transient ECG changes such as T-wave flattening, S-T segment depression and benign arrhythmias are not considered mandatory indications for the cessation of Myocet liposomal therapy.
Danish: Forbigående EKG-forandringer såsom T-taks-affladning, depression af S-T-segmentet og benigne arytmier betragtes ikke som obligatoriske indikationer for at ophøre med Myocet liposomalbehandling.
English: During clinical trials, the most frequently reported adverse reactions were nausea/vomiting (73%), leucopoenia (70%), alopecia (66%), neutropenia (46%), asthenia/fatigue (46%), stomatitis/mucositis (42%), thrombocytopenia (31%) and anaemia (30%).
Danish: Under de kliniske studier var de hyppigst rapporterede bivirkninger kvalme/opkastning (73 %), leukopeni (70 %), alopeci (66 %), neutropeni (46 %), asteni/træthed (46 %), stomatit/mucosit (42 %), trombocytopeni (31 %) og anæmi (30 %).
English: SHAKE VIGOROUSLY.
Danish: RYST DET KRAFTIGT.
English: When infused rapidly acute reactions associated with liposomal infusions have been reported.
Danish: Ved hurtig infusion er der rapporteret akutte reaktioner i forbindelse med liposom-infusioner.
English: • itchy, dry skin or swollen areas around hair roots
Danish: • kløende, tør hud eller hævede områder omkring hårrødderne
English: Before initiation of Myocet liposomal therapy a measurement of left ventricular ejection fraction (LVEF) is routinely recommended, either by Multiple Gated Arteriography (MUGA) or by echocardiography.
Danish: Inden behandling med Myocet liposomal indledes, anbefales rutinemæssigt en måling af venstre ventrikels uddrivningsfraktion (LVEF), enten via Multiple Gated Arteriography (MUGA) eller via ekkokardiografi.
English: Then the drip will be started in another vein.
Danish: Droppet vil derefter blive lagt i en anden blodåre.
English: Tell your doctor or nurse straight away if you notice any of the following side effects.
Danish: Fortæl det straks til lægen eller sundhedspersonalet, hvis du bemærker nogen af følgende bivirkninger.
English: Verify the temperature set point by checking the thermometer(s) on each heat block insert.
Danish: Kontrollér temperaturindstillingspunktet ved at kontrollere termometeret/termometrene i hver enkelt varmeblokindsats.
English: For dose reductions due to other toxicity, see section 4.4.
Danish: Vedrørende dosisreduktioner på grund af anden toksicitet, se pkt.
English: Specific medicinal product compatibility studies have not been performed with Myocet liposomal.
Danish: Der er ikke udført specifikke lægemiddel-kompatibilitetsstudier med Myocet liposomal.
English: The evaluation of left ventricular function is considered mandatory before each additional administration of Myocet liposomal once a patient exceeds a lifetime cumulative anthracycline dose of 550 mg/m2 or whenever cardiomyopathy is suspected.
Danish: Vurderingen af venstre ventrikels funktion betragtes som obligatorisk inden hver supplerende indgivelse af Myocet liposomal, når en patient overskrider den kumulative livsdosis af anthracyclin på 550 mg/m2, eller hvor der er mistanke om kardiomyopati.
English: Neutropenic sepsis
Danish: Neutropen sepsis
English: • Women who could get pregnant should use effective contraception during treatment with Myocet liposomal and for 6 months after treatment.
Danish: • Kvinder, som kan blive gravide, bør bruge sikker prævention under behandling med Myocet liposomal og i 6 måneder efter behandlingen.
English: 2 Painful erythema, oedema or ulcers but can eat.
Danish: 2 Smertefuldt erytem, ødem eller sår, men kan spise.
English: Vial 3 - buffer is a clear colourless solution.
Danish: Hætteglas 3 - buffer er en klar, farveløs opløsning.
English: The following adverse reactions have been reported with Myocet liposomal during clinical studies and post marketing experience.
Danish: Følgende bivirkninger ved Myocet liposomal er blevet rapporteret under kliniske studier og efter markedsføring.
English: 75% dose reduction
Danish: 75 % dosisreduktion