natgillin/translations-raw huggingface dataset:
Hvis der ikke ses en 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.
Hos de patienter, som oplever en infusionsreaktion, bør infusionsmetoden modificeres som følger:
In those patients who experience an infusion reaction, the method of infusion should be modified as follows:
5% af den totale dosis bør infunderes langsomt i løbet af de første 15 minutter.
5% of the total dose should be infused slowly over the first 15 minutes.
Hvis dette tåles uden reaktion, kan infusionshastigheden fordobles i løbet af de næste 15 minutter.
If tolerated without reaction, the infusion rate may then be doubled for the next 15 minutes.
Hvis dette tåles kan infusionen afsluttes i løbet af den næste time med en total infusionstid på 90 minutter.
If tolerated, the infusion may then be completed over the next hour for a total infusion time of 90 minutes.
AIDS- relateret KS:
AIDS-related KS:
Caelyx indgives intravenøst i en dosis på 20 mg/ m2 hver anden til tredje uge.
Caelyx is administered intravenously at 20 mg/ m2 every two-to-three weeks.
Caelyx- dosen fortyndes i 250 ml 5% (50 mg/ ml) glukose infusionsvæske og indgives som intravenøs infusion over 30 minutter.
The dose of Caelyx is diluted in 250 ml 5% (50 mg/ ml) glucose solution for infusion and administered by intravenous infusion over 30 minutes.
Til alle patienter:
For all patients:
4. 4 og 4. 8), seponer da øjeblikkeligt infusionen, giv hensigtsmæssig præmedicinering (antihistamin og/ eller kortvirkende kortikosteroid) og start igen med en langsommere hastighed.
If the patient experiences early symptoms or signs of infusion reaction (see sections 4.4 and 4.8), immediately discontinue the infusion, give appropriate premedications (antihistamine and/ or short acting corticosteroid) and restart at a slower rate.
Caelyx må ikke anvendes som bolusinjektion eller ufortyndet opløsning.
Do not administer Caelyx as a bolus injection or undiluted solution.
Det anbefales, at Caelyx infusionsslangen tilsættes som et sidedrop til en intravenøs infusion med 5% (50 mg/ ml) glukose for at opnå yderligere fortynding og mindske risiko for trombose og ekstravasation.
It is recommended that the Caelyx infusion line be connected through the side port of an intravenous infusion of 5% (50 mg/ ml) glucose to achieve further dilution and minimise the risk of thrombosis and extravasation.
Anvend ikke med in- line filtre.
Do not use with in-line filters.
6. 6).
Caelyx must not be given by the intramuscular or subcutaneous route (see section 6.6).
For at modvirke bivirkninger som palmar- plantart erythrodysæstesi (PPE), stomatitis eller hæmatologisk toksicitet, kan dosis reduceres eller udskydes.
To manage adverse events such as palmar-plantar erythrodysesthesia (PPE), stomatitis or haematological toxicity, the dose may be reduced or delayed.
Graduering af toksiciteten i disse tabeller er baseret på National Cancer Institute Common Toxicity Criteria (NCI- CTC).
The toxicity grading in these tables is based on the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
Tabellerne for PPE (tabel 1) og stomatitis (tabel 2) angiver fremgangsmåden, som blev fulgt for dosisjustering i kliniske undersøgelser af bryst - eller ovariecancerbehandling (justering af den anbefalede 4 ugers behandlingscyklus): hvis disse toksiciteter forekommer i patienter med AIDS relateret KS, kan den anbefalede 2 til 3 ugers behandlingscyklus modificeres på tilsvarende vis.
The tables for PPE (Table 1) and stomatitis (Table 2) provide the schedule followed for dose modification in clinical trials in the treatment of breast or ovarian cancer (modification of the recommended 4 week treatment cycle): if these toxicities occur in patients with AIDS related KS, the recommended 2 to 3 week treatment cycle can be modified in a similar manner.
Tabellen for hæmatologisk toksicitet (tabel 3) angiver fremgangsmåden, som blev fulgt for dosisjustering i kliniske undersøgelser af behandling af patienter udelukkende med bryst - eller ovariecancer.
The table for haematological toxicity (Table 3) provides the schedule followed for dose modification in clinical trials in the treatment of patients with breast or ovarian cancer only.
4. 8.
Dose modification in patients with AIDS-KS is addressed in 4.8.
3 Retningslinjer for Caelyx dosisjustering
3 Guidelines For Caelyx Dose Modification
PALMAR – PLANTART ERYTHRODYSESTHESI Uge efter forudgående Caelyx dosis Grad af toksicitet ved nuværende bedømmelse
PALMAR – PLANTAR ERYTHRODYSESTHESIA Week After Prior Caelyx Dose
Gendoser Gendoser
Redose unless Redose unless
Reducer dosis
Decrease dose by
(let erythema, hævelse
(mild erythema,
medmindre medmindre
patient has patient has
med 25%; vend
25%; return to
eller deskvamation,
swelling, or
patienten har haft en patienten har haft en
experienced a experienced a
tilbage til 4 ugers
4 week interval
som ikke forstyrrer daglige aktiviteter)
4 skin toxicity, in
forudgående forudgående Grad 3 eller 4 hud - Grad 3 eller 4 hud - toksicitet, i hvilket toksicitet, i hvilket
4 skin toxicity, in
interval
activities)
tilfælde der ventes en yderligere uge
which case wait an additional week
Vent en
Wait an additional Wait an additional
(erythema,
(erythema,
yderligere uge yderligere uge
week week
tilbage til 4 ugers deskvamation eller interval hævelse, som forstyrrer, men ikke udelukker, normale fysiske aktiviteter; små blister eller sårdannelser mindre end 2 cm i diameter)
swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter)
Vent en Vent en
Wait an additional Wait an additional
Træk patienten ud
Withdraw patient
(blisterdannelse, sårdannelse eller hævelse, som
(blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing)
yderligere uge yderligere uge
week
af behandlingen
week
(diffus eller lokal
(diffuse or local process causing infectious
proces, som forårsager infektiøse komplikationer eller en sengeliggende tilstand eller hospitalsindlæggelse)
complications, or a bedridden state or hospitalization)
4 Tabel 2.
4 Table 2.
STOMATITIS Uge efter forudgående Caelyx dosis Grad af toksicitet ved nuværende bedømmelse
STOMATITIS Week after Prior Caelyx Dose Toxicity Grade At Current Assessment
(smertefulde sår,
(painless ulcers,
erythema eller let
erythema, or mild
tilbage til 4 ugers
4 week interval or
ømhed)
soreness)
Grad 3 eller 4 stoma - titis, i hvilket tilfælde
previous Grade 3 or previous Grade 3 or 4 stomatitis in which 4 stomatitis in which case wait an case wait an additional week additional week
patienten ud af behandlingen i
withdraw patient per physician’ s assessment
(smertefuld erythema,
(painful erythema,
Vent en Vent en
oedema, or ulcers, but can eat)
Træk patienten ud
4 week interval or withdraw patient per physician’ s assessment
(smertefuld erythema, ødem eller sår, men kan ikke spise)
Grade 3 (painful erythema, edema, or ulcers, but cannot eat)
yderligere uge yderligere uge
Wait an additional Wait an additional week week
(kræver parenteral
Grade 4 (requires parenteral or enteral support)
af behandlingen
Withdraw patient
5 Tabel 3.
5 Table 3.
HÆMATOLOGISK TOKSICITET (ANC ELLER BLODPLADER) – BEHANDLING AF PATIENTER MED BRYST - ELLER OVARIECANCER
HAEMATOLOGICAL TOXICITY (ANC OR PLATELETS) – MANAGEMENT OF PATIENTS WITH BREAST OR OVARIAN CANCER
GRAD
GRADE
JUSTERING
MODIFICATION
1. 500
1,500 – 1,900
– 1. 900 75. 000 – 150. 000
75,000 – 150,000
1. 000 – < 1. 500
1,000 – < 1,500
50. 000 - < 75. 000
50,000 – < 75,000
Vent til ANC ≥ 1. 500 og blodplader ≥ 75. 000; gendoser uden dosisreduktion.
Wait until ANC ≥ 1,500 and platelets ≥ 75,000; redose with no dose reduction.
500 – < 1. 000
500 – < 1,000
25. 000 - < 50. 000
25,000 – < 50,000
< 25. 000
< 25,000
Vent til ANC ≥ 1. 500 og blodplader ≥ 75. 000; reducer dosis med 25% eller fortsæt normaldosis med støtte af vækstfaktor.
Wait until ANC ≥ 1,500 and platelets ≥ 75,000; decrease dose by 25% or continue full dose with growth factor support.
For patienter med multipelt myelom, der bliver behandlet med Caelyx i kombination med bortezomib, og som oplever PPE eller stomatitis, bør Caelyxdosis 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.
Tabel 4 nedenfor viser det skema, der er fulgt for andre doseringer i den kliniske undersøgelse af kombinationsbehandling med Caelyx og bortezomib af patienter med multipelt myelom.
Table 4, below provides the schedule followed for other dose modifications in the clinical trial in the treatment of patients with multiple myeloma receiving Caelyx and bortezomib combination therapy.
DOSISJUSTERING FOR CAELYX + BORTEZOMIB KOMBINATIONSBEHANDLING – PATIENTER MED MULTIPELT MYELOM
DOSAGE ADJUSTMENTS FOR CAELYX + BORTEZOMIB COMBINATION THERAPY - PATIENTS WITH MULTIPLE MYELOMA
Patientstatus
Patient Status
Feber ≥ 38○C og ANC < 1. 000/ mm3
Fever ≥ 38○ C and ANC < 1,000/ mm3
Indgiv ikke denne cyklus, hvis det er før Dag 4; hvis det er efter Dag 4, reducér næste dosis med 25%.
Do not dose this cycle if before Day 4; if after Day 4, reduce next dose by 25%.
Reducér næste dosis med 25%.
Reduce next dose by 25%.
På en hvilken som helst dag med indgivelse af medicin efter Dag 1 for hver cyklus:
On any day of medicine administration after Day 1 of each cycle:
Blodpladetal < 25. 000/ mm3 Hæmoglobin < 8 g/ dl ANC < 500/ mm3
Platelet count < 25,000/ mm3 Hemoglobin < 8 g/ dl ANC < 500/ mm3
Indgiv ikke denne cyklus, hvis det er før Dag 4; hvis det er efter Dag 4, reducér næste dosis med 25% i de efterfølgende cykluser, 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 hematologic toxicity. *
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.
Grad 3 eller 4 non - hæmatologisk medicinrelateret toksicitet
Grade 3 or 4 non-hematologic medicine related toxicity
Indgives ikke førend genvindelse af Grad < 2 og reducér dosis med 25% for alle efterfølgende doser.
Do not dose until recovered to Grade < 2 and reduce dose by 25% for all subsequent doses.
* Der henvises til produktresumeet for bortezomib for mere information om bortezomibdosis og dosisjustering.
*for more information on bortezomib dosing and dosage adjustment, 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, 2 – 3, 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%.
Hvis bilirubin er > 3, 0 mg/ dl, reduceres den første dosis med 50%.
If the bilirubin is > 3.0 mg/ dl, the first dose is reduced by 50%.
6 det næste dosis niveau, det vil sige hvis første dosis er reduceret med 25%, øg til normaldosis i cyklus 2; hvis første dosis er reduceret med 50%, øg til 75% af normaldosis i cyklus 2.
If the patient tolerates the first dose without an increase in serum bilirubin or liver enzymes, the dose for cycle 2 can be increased to the next dose level, i. e., if reduced by 25% for the first dose, increase to full dose for cycle 2; if reduced by 50% for the first dose, increase to 75% of full dose for cycle 2.
Caelyx kan anvendes til patienter med levermetastaser med samtidig forhøjelse af bilirubin og leverenzymer op til 4 gange den øvre grænse af normalområdet.
Caelyx can be administered to patients with liver metastases with concurrent elevation of bilirubin and liver enzymes up to 4 x the upper limit of
Vurder leverfunktionen ved brug af konventionelle kliniske laboratorieundersøgelser såsom ALT/ AST, alkalisk fosfatase og bilirubin før indgift af Caelyx.
Prior to Caelyx administration, evaluate hepatic function using conventional clinical laboratory tests such as ALT/ AST, alkaline phosphatase, and bilirubin.
Populations- farmakokinetiske resultater (i det undersøgte område for creatinin clearance 30 - 156 ml/ min) viser, at udskillelsen af Caelyx ikke påvirkes af nyrefunktionen.
Population pharmacokinetic data (in the range of creatinine clearance tested of 30 - 156 ml/ min) demonstrate that Caelyx clearance is not influenced by renal function.
Der findes ingen farmakokinetiske resultater hos patienter med creatinin clearance under 30 ml/ minut.
No pharmacokinetic data are available in patients with creatinine clearance of less than 30 ml/ min.
AIDS- KS patienter med splenektomi:
AIDS-KS patients with splenectomy:
Populations- baseret analyse viser, at alder over det undersøgte område (21 – 75 år) ikke signifikant ændrer farmakokinetikken af Caelyx.
Population based analysis demonstrates that age across the range tested (21 – 75 years) does not significantly alter the pharmacokinetics of Caelyx.
• Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne
• Hypersensitivity to the active substance or to any of the excipients.
Caelyx må ikke anvendes til behandling af AIDS- KS, der kan behandles effektivt med lokal terapi eller systemisk alfa- interferon.
Caelyx must not be used to treat AIDS-KS that may be treated effectively with local therapy or systemic alfa-interferon.
Kardiel toksicitet:
Cardiac toxicity:
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.
Imidlertid anses reduktion af QRS- bølgen som tegn på kardial toksicitet.
However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Indtræder denne ændring, skal den mest definitive test for antracyclin myokardiel skade, en endomyokardiel biopsi, overvejes.
If this change occurs, the most definitive test for anthracycline myocardial injury, i. e., endomyocardial biopsy, must be considered.
Mere specifikke metoder til evaluering og monitorering af hjertefunktion end EKG er måling af venstre ventrikels ejektionsfraktion ved ekkokardiografi eller endnu bedre ved flervejs- angiografi (MUGA).
More specific methods for the evaluation and monitoring of cardiac functions as compared to ECG are a measurement of left ventricular ejection fraction by echocardiography or preferably by Multigated Angiography (MUGA).
Vurderingen af venstre ventrikels funktion betragtes som obligatorisk før hver yderligere indgift af Caelyx, der overstiger en kumulativ dosis over livstid for antracyclin på 450 mg/ m2.
The evaluation of left ventricular function is considered to be mandatory before each additional administration of Caelyx that exceeds a lifetime cumulative anthracycline dose of 450 mg/ m2.
De ovenfor beskrevne tests og metoder til monitorering af hjertefunktionen under antracyclin - behandling skal anvendes i følgende rækkefølge, EKG monitorering, måling af venstre ventrikels ejektionsfraktion og endomyokardiel biopsi.
ECG monitoring, measurement of left ventricular ejection fraction, endomyocardial biopsy.
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
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.
7 og fordelen ved fortsat behandling skal omhyggeligt vurderes over for risikoen for at udvikle irreversibel skade på hjertet.
7 Congestive heart failure due to cardiomyopathy may occur suddenly, without prior ECG changes and may also be encountered several weeks after discontinuation of therapy.
Forsigtighed skal iagttages hos patienter, der har modtaget andre antracycliner.
Caution must be observed in patients who have received other anthracyclines.
I vurderingen af doxorubicinhydrochlorid dosis skal også indgå enhver forudgående (eller samtidig) behandling med kardiotoksiske præparater såsom andre antracycliner/ antraquinoner eller f. eks.
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.
Kardiotoksicitet kan også forekomme ved kumulative antracyclindoser mindre end 450 mg/ m2 hos patienter med forudgående mediastinal strålebehandling eller hos patienter i samtidig cyclophosphamidbehandling.
Cardiac toxicity also may occur at cumulative anthracycline doses lower than 450 mg/ m2 in patients with prior mediastinal irradiation or in those receiving concurrent cyclophosphamide therapy.
4. 8).
The cardiac safety profile for the dosing schedule recommended for both breast and ovarian cancer (50 mg/ m2) is similar to the 20 mg/ m2 profile in patients with AIDS-KS (see section 4.8).
Myelosuppression:
Myelosuppression:
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.
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/ m2, myelosuppression was generally mild to moderate, reversible, and was not associated with episodes of neutropaenic infection or sepsis.
Ydermere, i en kontrolleret klinisk undersøgelse af Caelyx sammenlignet med topotecan var hyppigheden af behandlingsrelateret sepsis betydelig mindre i Caelyx- behandlede ovariecancerpatienter i forhold til topotecan behandlingsgruppen.
Moreover, in a controlled clinical trial of Caelyx vs. topotecan, the incidence of treatment related sepsis was substantially less in the Caelyx-treated ovarian cancer patients as compared to the topotecan treatment group.
4. 8).
In contrast to the experience in patients with breast cancer or ovarian cancer, myelosuppression appears to be the dose-limiting adverse event in patients with AIDS-KS (see section 4.8).
I kontrollerede kliniske undersøgelser med patienter med AIDS- KS var opportunistiske infektioner tilsyneladende mere hyppige under behandling med Caelyx sammenlignet med bleomycin/ vincristin behandling.
In controlled clinical studies in patients with AIDS-KS against a bleomycin/ vincristine regimen, opportunistic infections were apparently more frequent during treatment with Caelyx.
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.
På grund af forskellen i farmakokinetiske egenskaber og doseringer må Caelyx ikke ombyttes med andre formuleringer af doxorubicin hydrochlorid.
Given the difference in pharmacokinetic profiles and dosing schedules, Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride.
Infusionsrelaterede reaktioner:
Infusion-associated reactions:
Alvorlige og nogle gange livstruende infusionsreaktioner, som er karakteriseret ved allergilignende eller anafylaksilignende reaktioner med symptomer omfattende astma, rødme, urticaria- udslæt, brystsmerte, feber, hypertension, takycardi, kløe, svedtendens, kortåndethed, ansigtsødem, kulderystelser, rygsmerte, sammensnørende fornemmelse over thorax og hals og/ eller hypotension, kan forekomme inden for minutter efter start af infusionen af Caelyx.
Serious and sometimes life-threatening infusion reactions, which are characterised by allergic-like or anaphylactoid-like reactions, with symptoms including asthma, flushing, urticarial rash, chest pain, fever, hypertension, tachycardia, pruritus, sweating, shortness of breath, facial oedema, chills, back pain, tightness in the chest and throat and/ or hypotension may occur within minutes of starting the infusion of Caelyx.
4. 8).
Very rarely, convulsions also have been observed in relation to infusion reactions (see section 4.8).
Medicin til at behandle disse symptomer (såsom antihistaminer, kortikosteroider, adrenalin og krampestillende midler) samt nødudstyr bør imidlertid være til rådighed for akut brug.
However, medications to treat these symptoms (e. g., antihistamines, corticosteroids, adrenaline, and anticonvulsants), as well as emergency equipment should be available for immediate use.
4. 2).
To minimise the risk of infusion reactions, the initial dose should be administered at a rate no greater than 1 mg/ minute (see section 4.2).
8 Diabetiske patienter:
Diabetic patients:
Bemærk venligst, at hvert hætteglas Caelyx indeholder saccharose og dosis indgives i 5% (50 mg/ ml) glukose infusionsvæske.
Please note that each vial of Caelyx contains sucrose and the dose is administered in 5% (50 mg/ ml) glucose solution for infusion.
4. 8.
For common adverse events which required dose modification or discontinuation see section 4.8.
4. 5 Interaktion med andre lægemidler og andre former for interaktion
8 4.5 Interaction with other medicinal products and other forms of interaction
Caelyx kan, som andre doxorubicin hydrochlorid- præparater, potensere toksiciteten af anden cancerbehandling.
Caelyx, like other doxorubicin hydrochloride preparations, may potentiate the toxicity of other anti-cancer therapies.
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.
Hos patienter med AIDS er forværring af cyclophosphamid- induceret hæmoragisk cystitis og forstærkning af 6- merkaptopurins levertoksiske virkning rapporteret for standard doxorubicin hydrochlorid.
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.
5. 3).
Women of child-bearing potential must be advised to avoid pregnancy while they or their male partner are receiving Caelyx and in the six months following discontinuation of Caelyx therapy (see section 5.3).