natgillin/translations-raw huggingface dataset:
Genopblussen af hudreaktion forårsaget af tidligere stråleterapi er i sjældne tilfælde set ved Caelyxbehandling.
Recall of skin reaction due to prior radiotherapy has rarely occurred with Caelyx administration.
Farmakokinetikken for Caelyx bestemt hos 18 patienter med brystcarcinom svarede til farmakokinetikken bestemt i den større population på 120 patienter med forskellige cancerformer.
The pharmacokinetics of Caelyx determined in 18 patients with breast carcinoma were similar to the pharmacokinetics determined in the larger population of 120 patients with various cancers.
Gennemsnitlig intrinsic clearance var 0,016 l/time/m2 (interval fra 0,008 - 0,027 l/time/m gennemsnitlig centrale fordelingsvolumen var 1,46 l/m 2 (interval fra 1,10 - 1,64 l/m 2).
The mean intrinsic clearance was 0.016 l/h/m2 (range 0.008-0.027 l/h/m2), the mean central volume of distribution was 1.46 l/m 2 (range 1.10-1.64 l/m 2).
EU/1/96/011/003 (1 hætteglas) EU/1/96/011/004 (10 hætteglas)
EU/1/96/011/003 (1 vial) EU/1/96/011/004 (10 vials)
Hypotension, ortostatisk hypotension, ansigtsrødme, hypertension, flebitis
Hypotension, orthostatic hypotension, flushing, hypertension, phlebitis
Anvend kun Caelyx til patienter med behandlingskrævende kardiovaskulær sygdom, hvis fordelen opvejer risikoen for patienten.
In patients with cardiac disease requiring treatment, administer Caelyx only when the benefit outweighs the risk to the patient.
Median-TTP var 6,5 måneder for patienterne, der fik bortezomib-monoterapi, sammenlignet med 9,3 måneder for de patienter, der fik Caelyx plus bortezomib-kombinationsbehandling.
The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the Caelyx plus bortezomib combination therapy patients.
Caelyx-dosen fortyndes i 250 ml glucose 50 mg/ml (5 %) infusionsvæske, opløsning 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.
Median-TTP var 6,9 måneder for patienterne, der fik bortezomib-monoterapi, sammenlignet med 8,9 måneder for patienterne, der fik kombinationsbehandling med Caelyx plus bortezomib.
The median TTP was 6.9 months for the bortezomib monotherapy patients compared with 8.9 months for the Caelyx plus bortezomib combination therapy patients.
EU/1/96/011/001 (1 hætteglas) EU/1/96/011/002 (10 hætteglas)
EU/1/96/011/001 (1 vial) EU/1/96/011/002 (10 vials)
Sådan skal du bruge Caelyx
How to use Caelyx
Pyridoxin (vitamin B6): - vitamin B6 kan fås uden recept.
Pyridoxine (Vitamin B6): - vitamin B6 is available without prescription; - take 50-150 mg daily beginning at the first signs of redness or tingling.
JUSTERING Grad 1 1.500 - 1.900 75.000 - 150.000 Genoptag behandling uden dosisreduktion.
75,000 - 150,000 Resume treatment with no dose reduction.
Hos 100 af 929 patienter (10,8 %) med massive tumorer blev infusionsrelaterede reaktioner beskrevet under behandling med Caelyx, karakteriseret ved følgende Costart termer: allergisk reaktion, anafylaktoid reaktion, astma, ansigtsødem, hypotension, vasodilatation, urticaria, rygsmerter,
100 out of 929 patients (10.8%) with solid tumours were described as having an infusion-associated reaction during treatment with Caelyx as defined by the following Costart terms: allergic reaction, anaphylactoid reaction, asthma, face oedema, hypotension, vasodilatation, urticaria, back pain, chest pain, chills, fever, hypertension, tachycardia, dyspepsia, nausea, dizziness, dyspnoea, pharyngitis, rash, pruritus, sweating, injection site reaction and medicinal product interaction.
I en samlet analyse af 4.231 patienter, som fik Caelyx til behandling af brystcancer, ovariecancer, myelomatose eller AIDS-relateret KS, blev ventrikulær arytmi, palpitationer, hjertesvigt, hjertestop, højresidig grenblok og reduceret uddrivningsfraktion (ejection fraction) rapporteret med hyppigheden ikke almindelig og atrioventrikulært blok, cyanose og ledningsforstyrrelse rapporteret med hyppigheden sjælden.
In a pooled analysis of 4,231 patients receiving Caelyx for breast cancer, ovarian cancer, multiple myeloma, or AIDS-related KS, ventricular arrythmia, palpitations, cardiac failure, cardiac arrest, bundle branch block right, and ejection fraction decreased were reported uncommonly, and atrioventricular block, cyanosis, and conduction disorder were reported rarely.
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
Caelyx må ikke indgives intramuskulært eller subkutant (se pkt.
Caelyx must not be given by the intramuscular or subcutaneous route (see section 6.6).
Grad 1 (smertefrie sår, erytem eller let ømhed)
Grade 1 (painless ulcers, erythema, or mild soreness)
Undersøgelser almindelig vægttab
Investigations common weight loss
Hjælpestoffer: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)- methoxypoly(oxyethylen)-40 natriumsalt, helhydrogeneret sojafosfatidylcholin, kolesterol, ammoniumsulfat, saccharose, histidin, vand til injektion, saltsyre og natriumhydroxid.
Excipients: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-methoxypoly(oxyethylen)-40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.
Caelyx må ikke administreres som bolusinjektion eller ufortyndet koncentrat.
Do not administer Caelyx as a bolus injection or undiluted solution.
Cytostatikum
Cytotoxic
En ml Caelyx indeholder 2 mg doxorubicinhydrochlorid i en pegyleret liposomal formulering.
One ml of Caelyx contains 2 mg of doxorubicin hydrochloride in a pegylated liposomal formulation.
Farmakokinetikken af Caelyx bestemt i 11 patienter med ovariecarcinom svarede til farmakokinetikken bestemt i en større population på 120 patienter med forskellige cancerformer.
The pharmacokinetics of Caelyx determined in 11 patients with ovarian carcinoma were similar to the pharmacokinetics determined in the larger population of 120 patients with various cancers.
Grad 2 1.000 - < 1.500 50.000 - < 75.000 Vent til ANC  1.500 og blodplader  75.000; gendoser uden dosisreduktion.
Grade 2 1,000 - < 1,500 50,000 - < 75,000 Wait until ANC  1,500 and platelets
Perifer sanseneuropati, neuralgi, hovedpine
Peripheral sensory neuropathy, neuralgia, headache
Bemærk, at hvert hætteglas Caelyx indeholder saccharose og dosis indgives i glucose 50 mg/ml (5 %) infusionsvæske, opløsning.
Please note that each vial of Caelyx contains sucrose and the dose is administered in 5% (50 mg/ml) glucose solution for infusion.
Pruritus, papuløst 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
CAELYX KARTON 50 mg/25 ml - 1 hætteglas CAELYX KARTON 50 mg/25 ml - 10 hætteglas
CAELYX CARTON 50 mg/25 ml - 1 vial CAELYX CARTON 50 mg/25 ml - 10 vials
En ml Caelyx indeholder 2 mg pegyleret liposomal doxorubicinhydrochlorid.
One ml of Caelyx contains 2 mg pegylated liposomal doxorubicin hydrochloride.
(24 til 73 liter/time/m2).
73 l/h/m2).
- Øvrige indholdsstoffer: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl) - methoxypoly(oxyethylen)-40 natriumsalt (MPEG-DSPE), helhydrogeneret sojafosfatidylcholin (HSPC), kolesterol, ammoniumsulfat, saccharose, histidin, vand til injektion, saltsyre (til justering af pH) og natriumhydroxid (til justering af pH).
- The other ingredients are -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE), fully hydrogenated soy phosphatidylcholine (HSPC), cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid (for pH-adjustment) and sodium hydroxide (for pH-adjustment).
Mave-tarm-kanalen meget almindelig kvalme almindelig diarre, stomatitis, opkastning, mundsår, abdominalsmerter, glossitis, obstipation, kvalme og opkastning
Gastrointestinal disorders very common nausea common diarrhoea, stomatitis, vomiting, mouth ulceration, abdominal pain, glossitis, constipation, nausea and vomiting
CAELYX KARTON 20 mg/10 ml - 1 hætteglas CAELYX KARTON 20 mg/10 ml - 10 hætteglas
CAELYX CARTON 20 mg/10 ml - 1 vial CAELYX CARTON 20 mg/10 ml - 10 vials
Caelyx må ikke ombyttes med andre formuleringer af doxorubicinhydrochlorid.
Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride.
Kvalme, stomatitis, opkastning, abdominalsmerte, diarre
Nausea, stomatitis, vomiting, abdominal pain, diarrhoea
Artralgi, myalgi, muskelkrampe, muskulær svaghed, smerte i bevægeapparatet, smerte i bevægeapparatet i brystregionen
Arthralgia, myalgia, muscle spasms, muscular weakness, musculoskeletal pain, musculoskeletal chest pain
Den gennemsnitlige intrinsic clearance var 0,021 liter/time/m2 (interval fra 0,009 - 0,041 liter/time/m2), det gennemsnitlige centrale fordelingsvolumen var 1,95 liter/m 2 (interval fra 1,67 - 2,40 liter/m 2).
The mean intrinsic clearance was 0.021 l/h/m2 (range 0.009-0.041 l/h/m2), the mean central volume of distribution was 1.95 l/m 2 (range 1.67-2.40 l/m 2).
Se tabel 6 for bivirkninger rapporteret hos patienter behandlet med Caelyx.
See Table 6 for undesirable effects reported in Caelyx-treated patients.
I en randomiseret fase III open-label multicenter-undersøgelse med parallelgruppe, der blev udført hos 646 patienter, blev sikkerhed og effekt af kombinationsbehandling med Caelyx og bortezomib sammenlignet med bortezomib monoterapi hos patienter med myelomatose.
A phase III randomised, parallel-group, open-label, multicentre study comparing the safety and efficacy of Caelyx plus bortezomib combination therapy with bortezomib monotherapy in patients with multiple myeloma who have received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy, was conducted in 646 patients.
Grad 3 500 - < 1.000 25.000 - < 50.000 Vent til ANC  1.500 og blodplader  75.000; gendoser uden dosisreduktion.
Grade 3 500 - < 1,000 25,000 - < 50,000 Wait until ANC  1,500 and platelets
Tabel 10. Farmakokinetiske parametre hos Caelyx-behandlede patienter med AIDSrelateret KS
Pharmacokinetic parameters in Caelyx-treated AIDS-KS patients Mean + standard error
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.
Intravenøs anvendelse, efter fortynding med glucose 50 mg/ml (5 %) infusionsvæske, opløsning.
Intravenous use, following dilution in 5% (50 mg/ml) glucose solution for infusion.
Asteni, lidelser i mukøse membraner
Asthenia, mucous membrane disorder
Meget sjældne bivirkninger (kan berøre op til 1 ud af 10.000 personer) - alvorlige hudreaktioner såsom udbredt skallende hud, blærer samt slimhindeskader (Stevens
Very rare side effects (may affect up to 1 in 10,000 people) - serious skin reactions such as widespread peeling skin, blisters as well as mucous membrane erosion (Stevens-Johnson syndrome/toxic epidermal necrolysis); - oral cancer may occur when Caelyx is taken for a long time (more than one year).
Abdominal smerte, dyspepsi
Abdominal pain, dyspepsia
På en hvilken som helst dag med indgivelse af medicin efter dag 1 for hver cyklus: Blodpladetal < 25.000/mm Hæmoglobin < 8 g/dl ANC < 500/mm
Platelet count < 25,000/mm Haemoglobin < 8 g/dl ANC < 500/mm
Vurder leverfunktionen ved brug af konventionelle kliniske laboratorieundersøgelser såsom ALAT/ASAT, 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.
For doser < 90 mg: fortynd Caelyx i 250 ml glucose 50 mg/ml (5 %) infusionsvæske, opløsning.
For doses < 90 mg: dilute Caelyx in 250 ml 5% (50 mg/ml) glucose solution for infusion.
Pneumoni, nasopharyngitis, infektion i øvre luftveje, svamp i munden
Pneumonia, nasopharyngitis, upper respiratory tract infection, oral candidiasis
Den opsugede dosis af Caelyx skal fortyndes i glucose 50 mg/ml (5 %) infusionsvæske, opløsning før indgivelse.
The appropriate dose of Caelyx must be diluted in 5% (50 mg/ml) glucose solution for infusion prior to administration.
Bulløs eruption, dermatitis, erytematøst udslæt, neglelidelse, skællende hud
Bullous eruption, dermatitis, erythematous rash, nail disorder, scaly skin
For doser  90 mg: fortynd Caelyx i 500 ml glucose 50 mg/ml (5 %) infusionsvæske, opløsning.
For doses  90 mg: dilute Caelyx in 500 ml 5% (50 mg/ml) glucose solution for infusion.
B-2340 Beerse Belgien
Turnhoutseweg 30 B-2340 Beerse Belgium
Ovariecancer-program
Ovarian cancer program
Caelyx blev givet i en dosis på 30 mg/m2 som intravenøs infusion over en time på 4. dagen efter indgivelsen af bortezomib.
Caelyx is administered at 30 mg/m² on day 4 of the bortezomib 3 week regimen as a 1 hour infusion administered immediately after the bortezomib infusion.
Det skal du vide, før du begynder at bruge Caelyx Sådan skal du bruge Caelyx Bivirkninger
What Caelyx is and what it is used for What you need to know before you use Caelyx How to use Caelyx
* 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
Tåreflåd, sløret syn
Lacrimation, blurred vision
- undgå at udsætte huden for meget varmt vand (f.eks. i jacuzzi, sauna).
- taking cool baths during hot weather; - avoiding vigorous exercise that might cause trauma to the feet (e.g., jogging); - avoiding exposure of skin to very hot water (e.g., jacuzzis, saunas); - avoiding tight fitting footwear or high-heeled shoes.
MÅ IKKE OMBYTTES MED ANDRE FORMULERINGER AF DOXORUBICINHYDROCHLORID.
DO NOT USE INTERCHANGEABLY WITH OTHER FORMULATIONS OF DOXORUBICIN HYDROCHLORIDE.
Det må ikke ombyttes med andre formuleringer af doxorubicinhydrochlorid.
It must not be used interchangeably with other formulations of doxorubicin hydrochloride.
Hos patienter, som oplever en infusionsreaktion, bør infusionsmetoden modificeres på følgende måde: 5 % af den totale dosis infunderes langsomt i løbet af de første 15 minutter.
5% of the total dose should be infused slowly over the first 15 minutes.
CAELYX ETIKET 20 mg/10 ml
CAELYX LABEL 20 mg/10 ml
CAELYX ETIKET 50 mg/25 ml
CAELYX LABEL 50 mg/25 ml
Den gennemsnitlige tilsyneladende halveringstid var 75,0 timer (interval fra 36,1 - 125 timer).
The mean apparent half-life was 71.5 hours (range
Dehydrering, kakeksi
Dehydration, cachexia
Der henvises til produktresumeet for bortezomib for mere detaljeret information om bortezomibdosis og dosisjustering.
For more detailed information on bortezomib dosing and dosage adjustments, see the SPC for bortezomib.
Ovariecancerpatienter
Ovarian cancer patients
Abdominalsmerte, diarre, kvalme, stomatitis
Abdominal pain, diarrhoea, nausea, stomatitis
Den gennemsnitlige intrinsic clearance af Caelyx var 0,030 liter/time/m2 (interval fra 0,008 til 0,152 liter/time/m2) og det gennemsnitlige centrale fordelingsvolumen var 1,93 liter/m2 (interval fra 0,96 - 3,85 liter/m2) nærmende sig plasmavolumen.
The mean intrinsic clearance of Caelyx was 0.030 l/h/m (range 0.008 to 0.152 l/h/m2) and the mean central volume of distribution was 1.93 l/m
Hvis du behandles for myelomatose og allerede har modtaget mindst 1 tidligere behandling, vil Caelyx blive givet i en dosis på 30 mg per kvadratmeter af din legemsoverfladeareal (baseret på din højde og vægt).
If you are being treated for multiple myeloma, and have already received at least 1 prior therapy, Caelyx will be administered at a dose of 30 mg per square metre of your body surface area (based on your height and weight) as a 1 hour intravenous infusion on day 4 of the bortezomib 3 week regimen immediately after the bortezomib infusion.
Brystcancer Alle sværhedsgrader n=254
AE by body system Breast cancer All severities n=254
Mundsår, øsofagitis, kvalme og opkastning, gastritis, dysfagi, mundtørhed, flatulens, tandkødsbetændelse, smagsforandring
Mouth ulceration, esophagitis, nausea and vomiting, gastritis, dysphagia, dry mouth, flatulence, gingivitis, taste perversion
Vægttab
GRADE
Anæmi, neutropeni, trombocytopeni
Anaemia, neutropaenia, thrombocytopaenia
Leukopeni, anæmi, neutropeni, trombocytopeni
Leukopaenia, anaemia, neutropaenia, thrombocytopaenia
Bulløst udslæt med småblærer, pruritus, eksfoliativ dermatitis, hudlidelser, makulopapuløst udslæt, svedtendens, acne, sår på huden
Vesiculobullous rash, pruritus, exfoliative dermatitis, skin disorder, maculopapular rash, sweating, acne, skin ulcer
Obstipation, abdominalsmerter, dyspepsi
Constipation, abdominal pain, dyspepsia
P-2740-262 Porto Salvo
P-2740-262 Porto Salvo Tel: +351 214 368 600
Asteni, træthed Perifert ødem, kulderystelser, influenzalignende sygdom, utilpashed, hypertermi
Peripheral oedema, chills, influenza-like illness, malaise, hyperthermia
Vasodilation
Vasodilatation
BLODPLADER
PLATELETS
- hold hænder og fødder frie (ingen handsker, strømper o.s.v.).
reading, or listening to the radio); - keeping hands and feet uncovered (no gloves, socks, etc.); - staying in cool places;
Febril neutropeni, lymfopeni
Anaemia, leukopaenia Febrile neutropaenia, lymphopaenia
Øvre abdominal smerte, mundsår, mundtørhed, dysfagi, stomatitis med blegner
Upper abdominal pain, mouth ulceration, dry mouth, dysphagia, aphthous stomatitis
Anafylaktoid reaktion
Anaphylactoid response
Svaghed, feber, smerte Asteni, ikke specifik mucositis
Weakness, fever, pain Asthenia, mucositis NOS
Kvalme, stomatitis, opkastning
Nausea, stomatitis, vomiting
Leukopeni, anæmi, trombocytopeni
Leukopaenia, anaemia, thrombocytopaenia
Kardiovaskulære sygdomme
Cardiovascular disorder
Abdominalsmerte, forstoppelse, diarre, dyspepsi, mundsår
Abdominal pain, constipation, diarrhoea, dyspepsia, mouth ulceration
Asteni, lidelser i mucøse membraner, smerte
Asthenia, mucous membrane disorder, pain
Lægen kan ønske at forsinke begyndelsen og/eller reducere dosis af den næste behandling (se Strategier for at modvirke og behandle hånd-fod syndrom, nedenunder).
The doctor may wish to delay the start and/or reduce the dose of the next treatment (see Strategies to prevent and treat hand-foot syndrome, below); - pain or sores in mouth or throat, nausea, vomiting, diarrhoea, constipation, loss of appetite, weight loss; - decrease in the number of white blood cells, which can increase the chances of infections.
Fortæl det til lægen eller apotekspersonalet, hvis noget af følgende passer på dig: - hvis du er i nogen form for behandling af hjerte- eller leversygdom.
You should tell your doctor about any of the following: - if you are receiving any treatment for heart disease or liver disease; - if you are diabetic, because Caelyx contains sugar which may require an adjustment to the treatment of your diabetes; - if you have Kaposi's sarcoma and have had your spleen removed; - if you notice sores, discolouration or any discomfort in your mouth.
Sådan vil du få Caelyx
How to store Caelyx
Hvis du har fået for meget Caelyx
If you use more Caelyx than you should
Kvalme, diarre, opkastning, stomatitis
Nausea, diarrhoea, vomiting, stomatitis
Sløvhed, hypæstesi, synkope, dysæstesi
Lethargy, hypoaesthesia, syncope, dysaesthesia
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.
Rygsmerter, myalgi
Back pain, myalgia
Parestesi
Paresthesia
Gennemsnitlig tilsyneladende halveringstid var 71,5 timer (interval fra 45,2 - 98,5 timer).
45.2-98.5 hours).
 1/10.000 til < 1/1.000
Grade 1 1,500 - 1,900
Forstoppelse, diarre, kvalme, stomatitis, opkastning
Constipation, diarrhoea, nausea, stomatitis, vomiting
Kvalme, diarre, opkastning, forstoppelse, stomatitis
Nausea, diarrhoea, vomiting, constipation, stomatitis
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 til < 1/10); Ikke almindelig (≥ 1/1.000 til < 1/100)
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
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 til < 1/10); Ikke almindelig (≥ 1/1.000 til
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
Caelyx er et lægemiddel mod tumorer/svulster.
Caelyx is an antitumour agent.
- du får hævelse, varme eller ømhed i det bløde væv på dine ben, nogle gange med smerter, der bliver værre, når du står eller går.
Contact your doctor immediately if: - you get reddening painful skin on your hands and feet; - you get painful reddening of the skin and/or blisters on the body or in the mouth; - you get heart problems; - you get mouth sores; - you develop a fever or any other sign of an infection; - you get sudden shortness of breath or sharp chest pain that may worsen with deep breathing or coughing; - you get swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain which gets worse when you stand or walk.
Forstoppelse, dyspepsi, mundsår
Constipation, dyspepsia, mouth ulceration
Abdominalsmerte, dyspepsi, mundsår
Abdominal pain, dyspepsia, mouth ulceration
Ovariecancer Alle sværhedsgrader/ n=512
CIOMS III AE by body system Ovarian cancer All severities n=512
Fertile kvinder
Women of child-bearing potential
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rivastigmine Sandoz den 11. december 2009.
The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Sandoz on 11 December 2009.
Den fuldstændige EPAR for Rivastigmine Sandoz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Rivastigmine Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Rivastigmine Sandoz skal gives to gange dagligt, sammen med morgen- og aftensmåltidet.
Rivastigmine Sandoz should be given twice a day, with morning and evening meals.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rivastigmine Sandoz.
This is a summary of the European public assessment report (EPAR) for Rivastigmine Sandoz.