natgillin/translations-raw huggingface dataset:
Retningslinjer for Caelyx-dosisjustering sekundært til ovennævnte bivirkninger er angivet i tabellerne nedenfor.
Guidelines for Caelyx dose modification secondary to these adverse effects are provided in the tables below.
Klinisk signifikante afvigelser i laboratorieværdier (grad 3 og 4) i denne gruppe var lav med øget total bilirubin, ASAT og ALAT rapporteret hos henholdsvis 2,4 %, 1,6 % og < 1 % af patienterne.
Clinically significant laboratory abnormalities (grades 3 and 4) in this group was low with elevated total bilirubin, AST and ALT reported in 2.4%, 1.6% and < 1% of patients respectively.
Der findes ingen farmakokinetiske data for patienter med creatinin clearance under 30 ml/minut.
No pharmacokinetic data are available in patients with creatinine clearance of less than 30 ml/min.
De hyppigst forekommende OI'er i kliniske undersøgelser var candidiasis, cytomegalovirus, herpes simplex, Pneumocystis carinii pneumoni og mycobakterium avium kompleks.
The most frequently observed OI's in clinical studies were candidiasis, cytomegalovirus, herpes simplex, Pneumocystis carinii pneumonia, and mycobacterium avium complex.
Caelyx kan, som andre doxorubicinhydrochlorid-præparater, potensere toksiciteten af anden cancerbehandling.
Caelyx, like other doxorubicin hydrochloride preparations, may potentiate the toxicity of other anti-cancer therapies.
Ved mistanke om kardiomyopati, det vil sige når venstre ventrikels ejektionsfraktion er faldet væsentligt i forhold til værdierne før behandlingen, og/eller venstre ventrikels ejektionsfraktion er lavere end en prognostisk relevant værdi (for eksempel < 45 %), kan endomyokardiel biopsi overvejes og fordelen ved fortsat behandling skal omhyggeligt vurderes over for risikoen for at udvikle irreversibel skade på hjertet.
Whenever cardiomyopathy is suspected, i.e., the left ventricular ejection fraction has substantially decreased relative to pre-treatment values and/or left ventricular ejection fraction is lower than a prognostically relevant value (e.g., < 45%), endomyocardial biopsy may be considered and the benefit of continued therapy must be carefully evaluated against the risk of developing irreversible cardiac damage.
Hvis der opstår tegn eller symptomer på ekstravasation (f.eks. svien eller erytem) afsluttes infusionen straks og genstartes i en anden vene.
If any signs or symptoms of extravasation occur (e.g., stinging, erythema) terminate the infusion immediately and restart in another vein.
På grund af risikoen for knoglemarvssuppression skal regelmæssige blodtællinger foretages under behandling med Caelyx, og som minimum før hver dosis af Caelyx.
Because of the potential for bone marrow suppression, periodic blood counts must be performed frequently during the course of Caelyx therapy, and at a minimum, prior to each dose of Caelyx.
Grad 3/4** n=318
Grades 3/4** n=318
1halveringstid (timer) 2halveringstid (timer)
1 half-life (hours)
Dog anses reduktion af QRSbølgen som tegn på kardial toksicitet.
However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Indgiv ikke denne cyklus, hvis det er før dag 4; hvis det er efter dag 4, reducér næste dosis med 25 % i de efterfølgende cyklusser, hvis bortezomib er reduceret for hæmatologisk toksicitet.
Do not dose this cycle if before day 4; if after day 4 reduce next dose by 25% in the following cycles if bortezomib is reduced for haematologic toxicity.
For patienter med myelomatose, der bliver behandlet med Caelyx i kombination med bortezomib, og som oplever PPE eller stomatitis, bør Caelyx-dosis ændres som beskrevet i henholdsvis Tabel 1 og 2 ovenfor.
For multiple myeloma patients treated with Caelyx in combination with bortezomib who experience PPE or stomatitis, the Caelyx dose should be modified as described in Table 1 and 2 above respectively.
Myelomatose-program
Multiple myeloma program
Desuden stoppede kun 1 patient (kumulativ antracyklin dosis på 944 mg/m2) forsøgsbehandlingen på grund af kliniske symptomer på hjerteinsufficiens.
Furthermore, only 1 patient (cumulative anthracycline dose of 944 mg/m2), discontinued study treatment because of clinical symptoms of congestive heart failure.
For yderligere instruktioner om tilberedning og særlige forholdsregler for håndtering, se pkt.
For further instructions on preparation and special precautions for handling see section 6.6.
Grad 3 stomatitis blev rapporteret hos 2 % af patienterne i gruppen, der fik kombinationsbehandling.
Grade 3 stomatitis was reported in 2% of patients in the combination therapy group.
- Til behandling af fremskreden ovariecancer hos kvinder, hvor førstevalgs platinbaseret kemoterapeutisk behandling er mislykket.
- For treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.
Sug den beregnede mængde Caelyx op i en steril sprøjte.
Take the appropriate volume of Caelyx up into a sterile syringe.
Grad 3 (blisterdannelse, sårdannelse eller hævelse, som forstyrrer gang eller normale daglige aktiviteter; kan ikke bære almindeligt tøj)
Grade 3 (blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing)
Udvis forsigtighed over for patienter med forringet hjertefunktion, der behandles med Caelyx.
Exercise caution in patients with impaired cardiac function who receive Caelyx.
Der skal udvises forsigtighed ved håndtering af Caelyx-opløsningen.
Caution must be exercised in handling Caelyx solution.
Den hæmatologiske toksicitet for ovariecancerpatienter er mindre svær end for AIDS-KS-gruppen (se afsnittet for patienter med ovariecancer ovenfor).
The haematological toxicity for ovarian cancer patients is less severe than in the AIDS-KS setting (see section for ovarian cancer patients above).
Caelyx bør kun indgives under opsyn af en kvalificeret onkolog specialiseret i indgift af cytotoksiske midler.
Caelyx should only be administered under the supervision of a qualified oncologist specialised in the administration of cytotoxic agents.
Vaskulære sygdomme almindelig vasodilatation
Vascular disorders common vasodilatation
Efter markedsføring har bulløst udslæt været rapporteret i sjældne tilfælde i denne patientgruppe.
Following marketing, bullous eruption has been reported rarely in this population.
Kemisk og fysisk holdbarhed under brug er påvist for 24 timer ved 2°C - 8°C.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
Mange patienter, der behandles med Caelyx, har baseline-myelosuppression som følge af faktorer såsom deres præeksisterende HIV-sygdom eller adskillige samtidige eller forudgående medicinske behandlinger eller tumorer involverende knoglemarven.
Many patients treated with Caelyx have baseline myelosuppression due to such factors as their pre-existing HIV disease or numerous concomitant or previous medications, or tumours involving bone marrow.
Doxorubicinhydrochlorid er mistænkt for at forårsage alvorlige fosterskader, hvis det anvendes under graviditet.
Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during pregnancy.
Dosis bør gentages så længe patienten responderer tilfredsstillende og tåler behandlingen.
The dose should be repeated as long as patients respond satisfactorily and tolerate treatment.
Hud og subkutane væv sjældne lichenoid keratose meget sjældne erytem multiform, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse
Skin and subcutaneous tissue disorders rare lichenoid keratosis very rare erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis
Caelyx er indiceret: - Som monoterapi til patienter med metastaserende brystcancer, hvor der er en øget kardiel risiko.
Caelyx is indicated: - As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.
Hvis der ikke ses infusionsreaktion, kan efterfølgende Caelyx infusioner indgives over en 60 minutters periode.
If no infusion reaction is observed, subsequent Caelyx infusions may be administered over a 60-minute period.
Ved kumulative doser på over 450 mg/m2 var der ingen kardielle hændelser med Caelyx.
At cumulative doses greater than 450 mg/m2 there were no cardiac events with Caelyx.
En øget forekomst af hjerteinsufficiens er forbundet med doxorubicin-behandling ved kumulative livstidsdoser > 450 mg/m2 eller ved lavere doser hos patienter med kardielle risikofaktorer.
An increased incidence of congestive heart failure is associated with doxorubicin therapy at cumulative lifetime doses > 450 mg/m2 or at lower doses for patients with cardiac risk factors.
Caelyx anvendes også i kombination med et andet lægemiddel, bortezomib, til behandling af myelomatose, en kræfttype, der kan forekomme i blodet hos patienter, der har fået mindst 1 tidligere behandling.
Caelyx is also used in combination with another medicine, bortezomib, to treat multiple myeloma, a cancer of the blood in patients who have received at least 1 prior therapy.
I kliniske undersøgelser hos patienter med massive tumorer (inklusive bryst- og ovariecancer), som samtidig har fået cyclophosphamid eller taxaner, sås ingen yderligere toksiciteter.
During clinical trials in patients with solid tumours (including breast and ovarian cancer) who have received concomitant cyclophosphamide or taxanes, no new additive toxicities were noted.
Gendoser medmindre patienten har haft en forudgående grad 3 eller 4 hudtoksicitet, i hvilket tilfælde der ventes en yderligere uge
Redose unless patient has experienced a previous grade 3 or 4 skin toxicity, in which case wait an additional week
Da doxorubicin metaboliseres i leveren og udskilles i galden, bør dosisjustering ikke være nødvendig.
As doxorubicin is metabolised by the liver and excreted in the bile, dose modification should not be required.
Brystcancer/ovariecancer/myelomatose
Breast cancer/Ovarian cancer/Multiple myeloma
Se produktresumeet for bortezomib.
See the SPC for bortezomib.
Caelyx farmakokinetik bestemt i et lille antal patienter med forhøjede total-bilirubin værdier afviger ikke fra patienter med normal total-bilirubin; indtil flere erfaringer er opnået, bør Caelyx-dosis i patienter med nedsat leverfunktion imidlertid reduceres baseret på erfaringen fra de kliniske ovarieundersøgelsesprogrammer for bryst- og ovariecancer som følger: hvis bilirubin er mellem 1,23,0 mg/dl ved initiering af behandlingen, reduceres den første dosis med 25 %.
Caelyx pharmacokinetics determined in a small number of patients with elevated total bilirubin levels do not differ from patients with normal total bilirubin; however, until further experience is gained, the Caelyx dosage in patients with impaired hepatic function should be reduced based on the experience from the breast and ovarian clinical trial programs as follows: at initiation of therapy, if the bilirubin is between 1.2-3.0 mg/dl, the first dose is reduced by 25%.
Som for andre DNA-beskadigende antineoplastiske stoffer har sekundære akutte myeloide leukæmier og myelodysplasier været rapporteret hos patienter, der har fået kombinationsbehandling med doxorubicin.
As with other DNA-damaging antineoplastic agents, secondary acute myeloid leukemias and myelodysplasias have been reported in patients having received combined treatment with doxorubicin.
Forhøjet aspartataminotransferase, nedsat ejektionsfraktion, forhøjet blodkreatinin, forhøjet alaninaminotransferase
Aspartate aminotransferase increased, ejection fraction decreased, blood creatinine increased, alanine aminotransferase increased
Farmakokinetikken af Caelyx over dosisintervallet 10 mg/m2 til 60 mg/m2 blev bedst beskrevet ved en to-kompartment non-lineær model med nulte ordens input og Michaelis-Menten elimination.
The pharmacokinetics of Caelyx over the dose range of 10 mg/m2 to 60 mg/m2 was best described by a two compartment non-linear model with zero order input and Michaelis-Menten elimination.
Caelyx kan anvendes som førstevalgs systemisk kemoterapi eller som andenhånds kemoterapi hos AIDS-KS patienter, hvis sygdom har progredieret med, eller hos patienter, der ikke tåler forudgående systemisk kombinationskemoterapi omfattende mindst to af følgende lægemidler: Et vinka-alkaloid, bleomycin og standard doxorubicin (eller andet antracyklin).
Caelyx may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).
I vurderingen af den samlede dosis doxorubicinhydrochlorid skal også indgå enhver forudgående (eller samtidig) behandling med kardiotoksiske præparater såsom andre antracykliner/antraquinoner eller f.eks. 5fluorouracil.
The total dose of doxorubicin hydrochloride must also take into account any previous (or concomitant) therapy with cardiotoxic compounds such as other anthracyclines/anthraquinones or e.g., 5-fluorouracil.
Sekundære hæmatologiske maligniteter
Secondary haematological malignancies
I meget sjældne tilfælde har kramper været set i forbindelse med infusionsrelaterede reaktioner.
Very rarely, convulsions have been observed in relation to infusion reactions.
Hvis et prøveresultat tyder på mulig kardiel skade i forbindelse med Caelyx-behandling, skal fordelen ved fortsat terapi nøje vurderes over for risikoen for kardiel skade.
If a test result indicates possible cardiac injury associated with Caelyx therapy, the benefit of continued therapy must be carefully weighed against the risk of myocardial injury.
Den kumulative dosis, hvor kardiotoksicitet kunne give grund til betænkning hos disse AIDS-KS patienter (> 400 mg/m2) ville kræve mere end 20 serier Caelyx-behandling over en 40 - 60 ugers periode.
The cumulative dose at which cardiotoxicity would become a concern for these AIDS-KS patients (> 400 mg/m2) would require more than 20 courses of Caelyx therapy over 40 to 60 weeks.
Nyretoksicitet er blevet set med selv lavere enkeltdoser af doxorubicinhydrochlorid hos rotter og kaniner.
Renal toxicity has been observed with even lower single doses of doxorubicin HCl in rats and rabbits.
Beregn den dosis af Caelyx, der skal indgives (baseret på den anbefalede dosis og patientens overfladeareal).
Determine the dose of Caelyx to be administered (based upon the recommended dose and the patient's body surface area).
Nedsat testikelvægt og hypospermi var tilstede i rotter efter gentagne doser  0,25 mg/kg/dag og diffus degeneration af de semniferøse tubuli og et markant fald i spermatogenesen blev observeret i hunde efter gentagne doser på 1 mg/kg/dag (se pkt.
Decreased testicular weights and hypospermia were present in rats after repeat doses 0.25mg/kg/day and diffuse degeneration of the seminiferous tubules and a marked decrease in spermatogenesis were observed in dogs after repeat doses of 1 mg/kg/day (see section 4.6).
Der er ikke udført egentlige lægemiddelinteraktionsundersøgelser med Caelyx, dog er der udført fase II kombinationsundersøgelser med konventionelle kemoterapeutiske stoffer hos patienter med ondartede gynækologiske sygdomme.
No formal medicinal product interaction studies have been performed with Caelyx, although phase II combination trials with conventional chemotherapy agents have been conducted in patients with gynaecological malignancies.
Hypokromisk anæmi
Hypochromic anaemia
Udvis forsigtighed ved samtidig anvendelse af lægemidler med kendt interaktion over for standard doxorubicinhydrochlorid.
Exercise caution in the concomitant use of medicinal products known to interact with standard doxorubicin hydrochloride.
Derudover blev der foretaget endomyokardiebiopsier hos 8 patienter med massive tumorer med kumulative antracyklin-doser på 509 mg/m2- 1.680 mg/m2.
In addition, endomyocardial biopsies were performed in 8 solid tumour patients with cumulative anthracycline doses of 509 mg/m2-1,680 mg/m2.
En undersøgelse har vist, at Caelyx i en enkelt intravenøs dosis på mere end to gange den kliniske dosis bevirker nyretoksicitet hos aber.
A study has shown that Caelyx at a single intravenous dose of over twice the clinical dose produces renal toxicity in monkeys.
I den centrale undersøgelse hos patienter med ovariecancer behandlet med en dosis på 50 mg/m2, var myelosuppression generelt let til moderat, reversibel og var ikke forbundet med episoder af neutropenisk infektion eller sepsis.
In the pivotal trial in patients with ovarian cancer treated at a dose of 50 mg/m myelosuppression was generally mild to moderate, reversible, and was not associated with episodes of neutropaenic infection or sepsis.
Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelig (≥ 1/1.000 til < 1/100)
Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100)
Dette giver Caelyx liposomerne mulighed for at cirkulere i blodet gennem længere perioder.
This allows the Caelyx liposomes to circulate for prolonged periods in the blood stream.
Indgives ikke, hvis 2 eller flere doser i en cyklus ikke er givet, reducér dosis med 25 % i de efterfølgende cykluser.
Do not dose; if 2 or more doses are not given in a cycle, reduce dose by 25% in following cycles.
Stigning i ASAT blev rapporteret mindre hyppigt (< 1 %).
Increases in AST were less frequently (< 1%) reported.
Ved ækvivalente doser er plasmakoncentrationen og AUC-værdierne for Caelyx, der primært repræsenterer pegyleret liposomal doxorubicinhydrochlorid (indeholdende 90 % til 95 % af det målte doxorubicin), betydeligt højere end de tilsvarende værdier for standard doxorubicinhydrochloridpræparationer.
At equivalent doses, the plasma concentration and AUC values of Caelyx which represent mostly pegylated liposomal doxorubicin hydrochloride (containing 90% to 95% of the measured doxorubicin) are significantly higher than those achieved with standard doxorubicin hydrochloride preparations.
Dermal toksicitet
Dermal toxicity
Paræstesi, somnolens
Paresthesia, somnolence
Bivirkninger i åndedrætssystemet forekom almindeligvis i kliniske undersøgelser med Caelyx og kan være relaterede til opportunistiske infektioner (OI'er) i AIDS-populationen.
Respiratory undesirable effects commonly occurred in clinical studies of Caelyx and may be related to opportunistic infections (OI's) in the AIDS population.
Ved undersøgelser udført efter gentagen indgift af Caelyx i rotter og hunde forekom alvorlig inflammation og ulcerationer ved klinisk relevante doser.
In studies performed after the repeated administration of Caelyx to rats and dogs, serious dermal inflammations and ulcer formations were observed at clinically relevant dosages.
I en gruppe på 410 patienter med ovariecancer forekom der klinisk signifikante laboratorieabnormiteter i kliniske undersøgelser med Caelyx inklusive stigning i total-bilirubin (sædvanligvis hos patienter med levermetastaser) (5 %) og serum-kreatinin (5 %).
In a subset of 410 patients with ovarian cancer, clinically significant laboratory abnormalities occurring in clinical trials with Caelyx included increases in total bilirubin (usually in patients with liver metastases) (5%) and serum creatinine levels (5%).
Afbryd midlertidigt Caelyx-behandling hos patienter med ANC tal < 1000/mm
Temporarily suspend Caelyx treatment in patients when the ANC count is < 1,000/mm
Caelyx indeholder sojaolie og natrium
Caelyx contains soya oil and sodium
Hvis du ønsker yderligere oplysninger om Caelyx, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Feber, smerte
Fever, pain
Undersøgelser i kaniner har vist, at kardiotoksiciteten af Caelyx er reduceret i forhold til konventionelle doxorubicinhydrochlorid præparationer.
Studies in rabbits have shown that the cardiotoxicity of Caelyx is reduced compared with conventional doxorubicin hydrochloride preparations.
Infusionsreaktioner kommer sjældent igen efter første behandlingscyklus med Caelyx (se pkt.
Infusion reactions rarely recur after the first treatment cycle with Caelyx (see section 4.2).
Metabolisme og ernæring almindelig anoreksi
Metabolism and nutrition disorders common anorexia
Det skal du vide, før du begynder at bruge Caelyx
What you need to know before you use Caelyx
Bivirkninger, som er blevet påvist efter markedsføringen af Caelyx, beskrives i tabel 9.
Adverse drug reactions identified during the post-marketing experience with Caelyx are described in Table 9.
Klinisk signifikante laboratorieabnormiteter forekom hyppigt ( 5 %) omfattende forøgelse af alkalisk fosfatase, ASAT og bilirubin, der mentes at være forbundet med den tilgrundliggende sygdom og ikke med Caelyx.
Clinically significant laboratory abnormalities frequently ( 5%) occurred including increases in alkaline phosphatase; AST and bilirubin which were believed to be related to the underlying disease and not Caelyx.
Forbigående EKG-ændringer såsom T-takudfladning, ST-depression og godartede arytmier anses ikke for at være tvingende årsag til seponering af Caelyx.
Transient ECG changes such as T-wave flattening, S-T segment depression and benign arrhythmias are not considered mandatory indications for the suspension of Caelyx therapy.
Angst, depression, søvnløshed
Anxiety, depression, insomnia
Lokal toksicitet
Local toxicity
Caelyx indeholder sojaolie.
Caelyx contains soya oil.
Doxorubicinhydrochlorid i Caelyx er indkapslet i fine dråber, der kaldes pegylerede liposomer, der hjælper med at bringe medicinen fra blodbanen til cancervævet i højere grad end til sundt, normalt væv.
The doxorubicin hydrochloride in Caelyx is enclosed in tiny spheres called pegylated liposomes which help to deliver the medicinal product from the blood stream to the cancerous tissue rather than healthy normal tissue.
3 og/eller thrombocyttal < 50.000/mm
3 and/or the platelet count is < 50,000/mm
Behandling af akut overdosering af den udtalt knoglemarvssupprimerede patient omfatter hospitalsindlæggelse, antibiotika, trombocyt- og granulocyttransfusioner samt symptomatisk behandling af mucositis.
Treatment of acute overdose of the severely myelosuppressed patient consists of hospitalisation, antibiotics, platelet and granulocyte transfusions and symptomatic treatment of mucositis.
Stomatitis har været rapporteret hos patienter i behandling med kontinuerlige infusioner af konventionel doxorubicinhydrochlorid og var hyppigt rapporteret hos patienter i Caelyx-behandling.
Stomatitis has been reported in patients receiving continuous infusions of conventional doxorubicin hydrochloride and was frequently reported in patients receiving Caelyx.
Almindelige bivirkninger, der førte til behandlingsafbrydelse af bortezomib og Caelyx, inkluderede PPE, neuralgi, perifer neuropati, perifer sensorisk neuropati, trombocytopeni, fald i ejektionsfraktion og træthed.
Common adverse events which led to treatment discontinuation of bortezomib and Caelyx included PPE, neuralgia, peripheral neuropathy, peripheral sensory neuropathy, thrombocytopaenia, decreased ejection fraction, and fatigue.
Mucositis (23 % mod 13 %; grad 3/4 4 % mod 2 %), og stomatitis (22 % mod 15 %; grad 3/4 5 % mod 2 %) blev rapporteret oftere med Caelyx end med doxorubicin.
Mucositis (23% vs. 13%; grade 3/4 4% vs. 2%), and stomatitis (22% vs. 15%; grade 3/4 5% vs. 2%) were reported more commonly with Caelyx than with doxorubicin.
Disse scoringer er ensbetydende med ingen eller let kardiotoksicitet.
These grading scores are consistent with no or mild cardiac toxicity.
Resumé af sikkerhedsprofilen Den hyppigst rapporterede bivirkning i bryst/ovariecancer kliniske undersøgelser (50 mg/m2 hver
Summary of the safety profile The most common undesirable effect reported in breast/ovarian clinical trials (50 mg/m every
Hos patienter med AIDS er forværring af cyclophosphamid-induceret hæmoragisk cystitis og forstærkning af 6-merkaptopurins levertoksiske virkning rapporteret for standard doxorubicinhydrochlorid.
In patients with AIDS, exacerbation of cyclophosphamide-induced haemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported with standard doxorubicin hydrochloride.