natgillin/translations-raw huggingface dataset:
Da mange lægemidler, inklusive anthracykliner, udskilles i modermælk og på grund af muligheden for alvorlige uønskede reaktioner hos diende spædbørn skal mødre derfor ophøre med at amme før påbegyndelse af Caelyx- behandling.
Because many medicinal products, including anthracyclines, are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, therefore mothers must discontinue nursing prior to beginning Caelyx treatment.
Der er imidlertid i kliniske undersøgelser indtil dato i sjældne tilfælde (< 5%) set svimmelhed og døsighed ved behandling med Caelyx.
However, in clinical studies to date, dizziness and somnolence were associated infrequently (< 5%) with the administration of Caelyx.
Den hyppigst rapporterede bivirkning i bryst/ ovariecancer kliniske undersøgelser (50 mg/ m2 hver 4. uge) var palmar- plantar erythrodysesthesi (PPE).
The most common undesirable effect reported in breast/ ovarian clinical trials (50 mg/ m2 every 4 weeks) was palmar-plantar erythrodysesthesia (PPE).
Den totale forekomst af rapporterede PPE var 44, 0% - 46, 1%.
The overall incidence of PPE reported was 44.0% - 46.1%.
De fleste af disse bivirkninger var lette, med alvorlige tilfælde (grad III) rapporteret i 17% - 19, 5%.
These effects were mostly mild, with severe (Grade III) cases reported in 17% - 19.5%.
Incidencen af rapporterede livstruende tilfælde (grad IV) var < 1%.
The reported incidence of life-threatening (Grade IV) cases was < 1%.
PPE resulterede sjældent i permanent afbrydelse af behandlingen (3, 7% - 7, 0%).
PPE infrequently resulted in permanent treatment discontinuation (3.7% - 7.0%).
Pyridoxin i en dosis på 50 - 150 mg om dagen og kortikosteroider er blevet anvendt forebyggende og til behandling af PPE, men denne terapi er ikke blevet evalueret i fase III.
Pyridoxine at a dose of 50 - 150 mg per day and corticosteroids have been used for the prophylaxis and treatment of PPE, however, these therapies have not been evaluated in phase III trials.
Andre måder til at undgå eller behandle PPE, som kan initieres i 4 til 7 dage efter behandling med Caelyx, inkluderer at holde hænder og fødder kolde ved at udsætte dem for køligt vand (iblødlægning, bade eller svømning), at undgå overdreven varme/ varmt vand og at holde dem nøgne (ingen strømper, handsker eller stramtsiddende sko).
Other strategies to prevent and treat PPE, which may be initiated for 4 to 7 days after treatment with Caelyx include keeping hands and feet cool, by exposing them to cool water (soaks, baths, or swimming), avoiding excessive heat/ hot water and keeping them unrestricted (no socks, gloves, or shoes that are tight fitting).
4. 2).
PPE appears to be primarily related to the dose schedule and can be reduced by extending the dose interval 1 - 2 weeks (see section 4.2).
9 påkræve afbrydelse af behandlingen.
However, this reaction can be severe and debilitating in some patients and may require discontinuation of treatment.
AIDS- KS).
Stomatitis/ mucositis and nausea were also commonly reported in breast/ ovarian cancer patient populations, whereas the AIDS-KS Program (20 mg/ m2 every 2 weeks), myelosuppression (mostly leukopaenia) was the most common side effect (see AIDS-KS).
PPE blev rapporteret hos 16% af patienterne med multipelt myelom, der blev behandlet med Caelyx og bortezomib kombinationsbehandling.
PPE was reported in 16% of multiple myeloma patients treated with Caelyx plus bortezomib combination therapy.
Grad 3 PPE blev rapporteret hos 5% af patienterne.
Grade 3 PPE was reported in 5% of patients.
De hyppigst rapporterede bivirkninger (medicinrelateret behandling- fremkommende) i kombinationsbehandling (Caelyx + bortezomib) var kvalme (40%), diarré (35%), neutropeni (33%), thrombocytopeni (29%), opkastning (28%), træthed (27%) og forstoppelse (22%).
9 (medicine-related treatment-emergent) adverse events in combination therapy (Caelyx + bortezomib) were nausea (40%), diarrhoea (35%), neutropaenia (33%), thrombocytopaenia (29%), vomiting (28%), fatigue (27%), and constipation (22%).
Brystcancer program:
Breast cancer program:
509 patienter med fremskreden brystcancer, som ikke tidligere havde modtaget kemoterapi for metastaserende sygdom, blev behandlet med Caelyx (n=254) i en dosis på 50 mg/ m2 hver 4. uge, eller doxorubicin (n=255) i en dosis på 60 mg/ m2 hver 3. uge, i en fase III klinisk undersøgelse (I97- 328).
509 patients with advanced breast cancer who had not received prior chemotherapy for metastatic disease were treated with Caelyx (n=254) at a dose of 50 mg/ m2 every 4 weeks, or doxorubicin (n=255) at a dose of 60 mg/ m2 every 3 weeks, in a phase III clinical trial (I97- 328).
De følgende almindelige bivirkninger blev rapporteret oftere med doxorubicin end med Caelyx: kvalme (53% mod 37%; grad III/ IV 5% mod 3%), opkastning (31% mod 19%; grad III/ IV 4% mod mindre end 1%), enhver alopeci (66% mod 20%), udtalt alopeci (54% mod 7%) og neutropeni (10% mod 4%; grad III/ IV 8% mod 2%).
13%; Grade III/ IV 4% vs.
Mucositis (23% mod 13%; grad III/ IV 4% mod 2%), og stomatitis (22% mod 15%; grad III/ IV 5% mod 2%) blev rapporteret oftere med Caelyx end med doxorubicin.
2%) were reported more commonly with Caelyx than with doxorubicin.
Gennemsnitsvarigheden af de mest alvorlige tilfælde (grad III/ IV) for begge grupper var 30 dage eller mindre.
The average duration of the most common severe (Grade III/ IV) events for both groups was 30 days or less.
Se tabel 5 for en komplet liste over uønskede reaktioner rapporteret i Caelyx- behandlede patienter.
See Table 5 for complete listing of undesirable effects reported in Caelyx-treated patients.
Incidensen af livstruende (grad IV) hæmatologiske reaktioner var < 1, 0% og sepsis blev rapporteret hos 1% af patienterne.
The incidence of life threatening (Grade IV) haematologic effects was < 1.0% and sepsis was reported in 1% of patients.
4. 2).
Growth factor support or transfusion support was necessary in 5.1% and 5.5% of patients, respectively (see section 4.2).
Klinisk signifikante afvigelser i laboratorieværdier (grad III og IV) i denne gruppe var lav med øget total bilirubin, AST og ALT rapporteret hos henholdsvis 2, 4%, 1, 6% og < 1% af patienterne.
Clinically significant laboratory abnormalities (Grades III and IV) in this group was low with elevated total bilirubin, AST and ALT reported in 2.4%, 1.6% and < 1% of patients respectively.
Ingen klinisk signifikant øgning i serum creatinin blev rapporteret.
No clinically significant increases in serum creatinine were reported.
Behandlingsrelaterede bivirkninger rapporteret i brystcancer kliniske undersøgelser (50 mg/ m2 hver 4. uge) (Caelyx- behandlede patienter) efter sværhedsgrad, systemorganklasser i henhold til MedDRA- databasen og standardterminologi Meget almindelig (≥ 1/ 10); Almindelig (≥ 1/ 100, < 1/ 10); Ikke almindelig (≥ 1/ 1. 000, < 1/ 100) CIOMS III Bivirkninger efter
Treatment Related Undesirable Effects Reported in Breast Cancer Clinical Trials (50 mg/ m2 every 4 weeks) (Caelyx-treated patients) by Severity, MedDRA System Organ Class and Preferred Term
Brystcancer Brystcancer
Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100) CIOMS III AE by body system
Alle sværhedsgrader
Breast Cancer All Severities n=254
Grad III/ IV
Breast Cancer Grades III/ IV n=254
n=404
Breast Cancer n=404 (1-5%)
n=254 n=254
Infections and infestations
(1- 5%)
(≥ 5%)
(≥ 5%) (≥ 5%)
(≥ 5%)
ikke tidligere
not
rapporteret i kliniske undersøgelser
previously reported in clinical trials
10 Infektioner og parasitære sygdomme Almindelig
Common
Pharyngitis
Pharyngitis
Folliculitis, svampeinfektion, forkølelsessår (non - herpetisk), infektion i øvre luftveje
Folliculitis, fungal infection, cold sores (non-herpetic), upper respiratory tract infection
Ikke almindelig Blod og lymfesystem
Uncommon Blood and lymphatic system disorders
Leukopeni, anæmi, neutropeni, thrombocytopeni
Leukopaenia, anaemia, neutropaenia, thrombocytopaenia
Thrombocytæmi
Thrombocythemia
Ikke almindelig
Uncommon Metabolism and nutrition disorders
Almindelig Nervesystemet
Common Nervous system disorders
Ikke almindelig Øjne
Uncommon Eye Disorders
Almindelig Hjerte
Common Cardiac disorders
Almindelig Luftveje, thorax og mediastinum
Common Respiratory, thoracic and mediastinal disorders
Mave- tarmkanalen Meget almindelig
11 Gastrointestinal disorders Very Common
Ikke almindelig
Uncommon Skin and subcutaneous tissue disorders
Mundsår, forstoppelse, opkastning
Mouth ulceration, constipation, Vomiting
11 Hud og subkutane væv Meget almindelig Almindelig
Very Common
PPE *, alopeci, udslæt
PPE*, alopecia, rash
Ikke almindelig Knogler, led, muskler og bindevæv
Common
Tør hud, misfarvning af huden, unormal pigmentering, erythem
Dry skin, skin discolouration, pigmentation abnormal, erythema
Udslæt Unormal pigmentering, erythem
Rash
Bulløs eruption, dermatitis, erythematøst udslæt, neglelidelse, skællende hud
Bullous eruption, dermatitis, erythematous rash, nail disorder, scaly skin
Almindelig Det reproduktive system og mammae
Uncommon Musculoskeletal and connective tissue disorders
Benkramper, knoglesmerter, smerter i bevægeapparatet
Pigmentation abnormal, erythema
Almindelig
Common Reproductive system and breast disorders
Brystsmerter
Leg cramps, bone pain, musculoskeletal pain
Almene symptomer og reaktioner på administrationsstedet
Common General disorders and administration site conditions
Astheni, træthed, ikke specifik mucositis
Asthenia, fatigue, mucositis NOS
Astheni, ikke specifik mucositis
Asthenia, mucositis NOS
Ikke almindelig
Uncommon * palmar-plantar erythrodysesthesia (Hand- foot syndrome).
Ovariecancer program:
Ovarian cancer program:
512 patienter med ovariecancer (en gruppe på 876 solide tumorpatienter) blev behandlet med Caelyx med en dosis på 50 mg/ m2 i kliniske undersøgelser.
512 patients with ovarian cancer (a subset of 876 solid tumour patients) were treated with Caelyx at a dose of 50 mg/ m2 in clinical trials.
Se tabel 6 for uønskede effekter rapporteret hos patienter behandlet med Caelyx.
See Table 6 for undesirable effects reported in Caelyx-treated patients.
Behandlingsrelaterede bivirkninger rapporteret i ovariecancer kliniske undersøgelser (50 mg/ m2 hver 4. uge) (Caelyx- behandlede patienter) efter sværhedsgrad, systemorganklasser i henhold til MedDRA- databasen og standardterminologi Meget almindelig (≥ 1/ 10); Almindelig (≥ 1/ 100, < 1/ 10); Ikke almindelig (≥ 1/ 1. 000, < 1/ 100) CIOMS III Bivirkninger efter
Table 6 Treatment Related Undesirable Effects Reported in Ovarian Cancer Clinical Trials (50 mg/ m2 every 4 weeks) (Caelyx-treated patients) by Severity, MedDRA System Organ Class and Preferred Term Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100) CIOMS III
Ovariecancer Ovariecancer
12 AE by body system
Ovariecancer
Ovarian Cancer Ovarian Cancer All Severities Grades III/ IV n=512 n=512 (≥ 5%) (≥ 5%)
organsystem
Ovarian Cancer n=512 (1-5%)
Alle sværhedsgrader /
Infections and infestations
n=512
Common
n=512 (≥ 5%)
Pharyngitis
n=512 (≥ 5%)
Infection, oral moniliasis, herpes zoster, urinary tract infection
12 Infektioner og parasitære sygdomme Almindelig Ikke almindelig Blod og lymfesystem Meget almindelig
Uncommon Blood and lymphatic system disorders
Pharyngitis
Very Common
Almindelig Immunsystemet
Common
Leukopeni, anæmi, thrombocytopeni
Leukopaenia, anaemia, thrombocytopaenia
Hypochromisk anæmi
Hypochromic anaemia
Almindelig Metabolisme og ernæring
Common Metabolism and nutrition disorders
Ikke almindelig Psykiske forstyrrelser Almindelig Nervesystemet
Uncommon Psychiatric disorders
Ikke almindelig Øjne
Uncommon Eye disorders
Almindelig Vaskulære sygdomme Almindelig Luftveje, thorax og mediastinum
Common Vascular disorders
Kardiovaskulære sygdomme Vasodilation
Cardiovascular disorder
Dyspnø, øget hoste
Vasodilatation
13 Mave- tarmkanalen Meget almindelig
13 Respiratory, thoracic and mediastinal disorders Common
Mundsår, esofagitis, kvalme og opkastning, gastritis, dysfagi, mundtørhed, flatulence, tandkødsbetændelse, smagsforandring
Mouth ulceration, esophagitis, nausea and vomiting, gastritis, dysphagia, dry mouth, flatulence, gingivitis, taste perversion
Ikke almindelig Hud og subkutane væv Meget almindelig
Uncommon Skin and subcutaneous tissue disorders
Almindelig
Very Common
Knogler, led, muskler og bindevæv Almindelig Nyrer og urinveje
Common Musculoskeletal and connective tissue disorders
Bulløst udslæt med småblærer, pruritus, exfoliativ dermatitis, hudlidelser, maculopapulært udslæt, svedtendens, acne, sår på huden Rygsmerter, myalgi
Vesiculobullous rash, pruritus, exfoliative dermatitis, skin disorder, maculopapular rash, sweating, acne, skin ulcer
Almindelig Det reproduktive system og mammae Almindelig Almene symptomer og reaktioner på administrationsstedet
Common Reproductive system and breast disorders
Dysuri Vaginitis
Vaginitis
Astheni, lidelser i mucøse membraner
Asthenia, mucous membrane disorder
Astheni, lidelser i mucøse membraner, smerte
Asthenia, mucous membrane disorder, pain
Kulderystelse, brystsmerte, utilpashed, perifer ødem
Chills, chest pain, malaise, peripheral oedema
Ikke almindelig Undersøgelser
Uncommon
Almindelig
14 Investigations Common
* palmar- plantar erythrodysesthesia (Hand - foot syndrome)
* palmar-plantar erythrodysesthesia (Hand- foot syndrome).
Myelosuppression var for det meste mild eller moderat og let at styre.
Myelosuppression was mostly mild or moderate and manageable.
Sepsis relateret til leukopeni blev observeret sjældent (< 1%).
Sepsis related to leukopaenia was observed infrequently (< 1%).
4. 2).
Growth factor support was required infrequently (< 5%) and transfusion support was required in approximately 15% of patients (see section 4.2).
14 I en gruppe på 410 patienter med ovariecancer forekom der klinisk signifikante laboratorieabnormiteter i kliniske undersøgelser med Caelyx inklusive øgning i total bilirubin (sædvanligvis hos patienter med levermetastaser) (5%) og serum creatinin niveauer (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%).
Øgning i AST var mindre hyppigt (< 1%) rapporteret.
Increases in AST were less frequently (< 1%) reported.
Solide tumorpatienter: i en større gruppe på 929 patienter med solide tumorer (inklusive brystcancer og ovariecancer) overvejende behandlet med en dosis på 50 mg/ m2 hver 4. uge, er sikkerhedsprofilen og forekomsten af bivirkninger sammenlignelig med hvad der sås for patienter behandlet i de pivotale brystcancer og ovariecancer undersøgelser.
Solid tumour patients: in a larger cohort of 929 patients with solid tumours (including breast cancer and ovarian cancer) predominantly treated at a dose of 50 mg/ m2 every 4 weeks, the safety profile and incidence of adverse effects are comparable to those of the patients treated in the pivotal breast cancer and ovarian cancer trials.
Multipelt Myelom program:
Multiple Myeloma program:
Bortezomib indgives i en dosis på 1, 3 mg/ m2 på dag 1, 4, 8 og 11 hver tredje uge eller som bortezomib monoterapi i en fase III klinisk undersøgelse.
Of 646 patients with multiple myeloma who have received at least 1 prior therapy, 318 patients were treated with combination therapy of Caelyx 30 mg/ m2 as a one hour intravenous infusion administered on day 4 following bortezomib which is administered at 1.3 mg/ m² on days 1, 4, 8, and 11, every three weeks or with bortezomib monotherapy in a phase III clinical trial.
Se tabel 7 for bivirkninger rapporteret hos ≥ 5% af de patienter, der blev behandlet med Caelyx og bortezomib kombinationsbehandling.
See Table 7 for adverse effects reported in ≥ 5% patients treated with combination therapy of Caelyx plus bortezomib.
Neutropeni, thrombocytopeni og anæmi var de hyppigste rapporterede hæmatologiske tilfælde, der blev rapporteret ved både kombinationsbehandling med Caelyx og bortezomib og bortezomib monoterapi.
Neutropaenia, thrombocytopaenia, and anaemia were the most frequently reported hematologic events reported with both combination therapy of Caelyx plus bortezomib and bortezomib monotherapy.
Forekomsten af grad 3 og grad 4 neutropeni var højere hos gruppen, der var i kombinationsbehandling end i monoterapi- gruppen (28% vs.
The incidence of grade 3 and 4 neutropaenia was higher in the combination therapy group than in the monotherapy group (28% vs.
Forekomsten af grad 3 og grad 4 thrombocytopeni var højere hos gruppen, der var i kombinationsbehandling end i monoterapi- gruppen (22% vs.
The incidence of grade 3 and 4 thrombocytopaenia was higher in the combination therapy group than in the monotherapy group (22% vs.
Forekomsten af anæmi var tilsvarende i begge behandlingsgrupper.
5%).
Stomatitis blev rapporteret hyppigere i gruppen, der fik kombinationsbehandling (16%) end i monoterapi- gruppen (3%), og de fleste tilfælde var grad 2 eller mindre i sværhedsgrad.
Stomatitis was reported more frequently in the combination therapy group (16%) than in the monotherapy group (3%), and most cases were grade 2 or less in severity.
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.
Kvalme og opkastning blev rapporteret hyppigere i gruppen, der fik kombinationsbehandling (40% og 28%) end i monoterapi- gruppen (32% og 15%) og var fortrinsvist af grad 1 og 2 sværhedsgrad.
Nausea and vomiting were reported more frequently in the combination therapy group (40% and 28%) than in the monotherapy group (32% and 15%) and were mostly grade 1 and 2 in severity.
Behandlingsstop af én eller begge stoffer som følge af bivirkninger, blev set i 38% af patienterne.
Treatment discontinuation of one or both agents due to adverse events was seen in 38% of patients.
Almindelige bivirkninger, der førte til behandlingsstop af bortezomib og Caelyx inkluderede PPE, neuralgi, perifer neuropati, perifer sanseneuropati, thrombocytopeni, 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.
Behandlingsrelaterede bivirkninger, der er rapporteret ved kliniske undersøgelser af Multipelt Myelom (Caelyx 30 mg/ m2 i kombination med bortezomib hver 3. uge) efter sværhedsgrad, systemorganklasser i henhold til MedDRA- databasen og foretrukken term Meget Almindelig (≥ 1/ 10); Almindelig (≥ 1/ 100, < 1/ 10); Ikke almindelig (≥ 1/ 1. 000, < 1/ 100) CIOMS III Systemorganklasser Infektioner og parasitære sygdomme
Treatment Related Undesirable Effects Reported in Multiple Myeloma Clinical Trial (Caelyx 30 mg/ m2 in combination with bortezomib every 3 weeks) by Severity, MedDRA System Organ Class and Preferred Term Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100) CIOMS III AE by body system
Alle sværhedsgrader n=318 (≥ 5%)
All Severities n=318
Grad III/ IV ** n=318 (≥ 5%)
Grades III/ IV** n=318
Alle sværhedsgrader n=318 (1- 5%)
Severities n=318
Almindelig
15 Infections and infestations Common Blood and lymphatic system disorders
Lungebetændelse, nasopharyngitis, infektion i øvre luftveje, svamp i munden
Pneumonia, nasopharyngitis, upper respiratory tract infection, oral candidiasis
15 Blod og lymfesystem Meget almindelig
Very Common
Anæmi, neutropeni, thrombocytopeni
Anaemia, neutropaenia, thrombocytopaenia
Neutropeni, thrombocytopeni
Neutropaenia, thrombocytopaenia
Almindelig Metabolisme og ernæring
Common Metabolism and Nutrition disorders
Anæmi, leukopeni
Anaemia, leukopaenia
Febril neutropeni, lymfopeni
Febrile neutropaenia, lymphopaenia
Dehydrering, hypokalæmi, hyperkalæmi, hypomagnesæmi, hyponatriæmi, hypocalcæmi
Dehydration, hypokalaemia, hyperkalaemia, hypomagnesaemia, hyponatraemia, hypocalcaemia
Ikke almindelig Psykiske forstyrrelser
Uncommon Psychiatric disorders
Sløvhed, hypoestesi, synkope, dysestesi
Lethargy, hypoaesthesia, syncope, dysaesthesia
Ikke almindelig
Uncommon Eye disorders
Øjne Almindelig Vaskulære sygdomme
Common Vascular disorders
Hypotension, ortostatisk hypotension, rødmen, hypertension, flebitis
Hypotension, orthostatic hypotension, flushing, hypertension, phlebitis
16 Luftveje, thorax og mediastinum Almindelig
16 Respiratory, thoracic, and mediastinal disorders Common
Ikke almindelig Mave- tarmkanalen
Uncommon Gastrointestinal disorders
Kvalme, diarré, opkastning, forstoppelse, stomatitis
Nausea, diarrhoea, vomiting, constipation, stomatitis
Kvalme, diarré, opkastning, stomatitis
Nausea, diarrhoea, vomiting, stomatitis
Ikke almindelig Hud og subkutane væv
Uncommon Skin and subcutaneous tissue disorders
Forstoppelse, abdominal smerte, dyspepsi
Constipation, abdominal pain, dyspepsia
PPE *, udslæt
PPE*, rash
Pruritus, papulært udslæt, allergisk dermatitis, erytem, hyperpigmentering af hud, petekkier, alopeci, udslæt pga. medicinsk behandling
Pruritus, papular rash, allergic dermatitis, erythema, skin hyperpigmentation, petechiae, alopecia, medicine eruption
Ikke almindelig Knogler, led, muskler og bindevæv
Uncommon Musculoskeletal and connective tissue disorders
Almindelig Det reproduktive system og mammae
Common Reproductive system and breast disorders
Almindelig Almene symptomer og reaktioner på administrationsstedet
Common General disorders and administration site conditions
Asteni, træthed
Asthenia, fatigue
Perifert ødem, kulderystelser, influenza - lignende sygdom, utilpashed, hypertermi
Peripheral oedema, chills, influenza-like illness, malaise, hyperthermia
17 Undersøgelser Almindelig
17 Investigations Common
Øget aspartataminotransferase, nedsat ejektionsfraktion, øget blodkreatinin, øget alaninaminotransferase
Aspartate aminotransferase increased, ejection fraction decreased, blood creatinine increased, alanine aminotransferase increased
* Palmar- plantar erythrodysestesi (Hånd- fod syndrom). ** Grad 3/ 4 bivirkning er baseret på bivirkningstermerne af alle sværhedsgrader med et overordnet tilfælde ≥ 5% (se bivirkningerne listet i første kolonne).
* Palmar-plantar erythrodysesthesia (Hand-foot syndrome). ** Grade 3/ 4 adverse events are based on the adverse event terms of all severities with an overall incidence ≥ 5% (see adverse events listed in first column).
AIDS- KS program:
AIDS-KS program:
Kliniske undersøgelser af AIDS- KS patienter behandlet med 20 mg/ m2 Caelyx viser, at myelosuppression var den hyppigste bivirkning, der anses for at være forbundet med Caelyx - behandling, forekommende meget almindeligt (hos omkring en halvdel af patienterne).
Clinical studies on AIDS-KS patients treated at 20 mg/ m2 with Caelyx show that myelosuppression was the most frequent undesirable effect considered related to Caelyx occurring very commonly (in approximately one-half of the patients).
Leukopeni er den hyppigst erfarede bivirkning af Caelyx i denne patientgruppe; neutropeni, anæmi og thrombocytopeni er blevet observeret.
Leukopaenia is the most frequent undesirable effect experienced with Caelyx in this population; neutropaenia, anaemia and thrombocytopaenia have been observed.
Afbryd midlertidigt Caelyx behandling hos patienter med ANC tal < 1000/ mm3 og/ eller thrombocyttal < 50. 000/ mm3.
Temporarily suspend Caelyx treatment in patients when the ANC count is < 1,000/ mm3 and/ or the platelet count is < 50,000/ mm3.
G- CSF (eller GM- CSF) kan gives som samtidig behandling for at øge antallet af blodlegemer, når ANC- tallet er < 1000/ mm3 i efterfølgende cykluser.
G-CSF (or GM-CSF) may be given as concomitant therapy to support the blood count when the ANC count is < 1,000/ mm3 in subsequent cycles.
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).