natgillin/translations-raw huggingface dataset:
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/ m2 (range 0.008 to 0.152 l/ h/ m2) and the mean central volume of distribution was 1.93 l/ m2 (range 0.96 – 3.85 l/ m2) approximating the plasma volume.
Den tilsyneladende halveringstid varierer fra 24 – 231 timer, med et gennemsnit på 73, 9 timer.
The apparent half-life ranged from 24 – 231 hours, with a mean of 73.9 hours.
Brystcancerpatienter Farmakokinetikken for Caelyx bestemt hos 18 patienter med brystcarcinom svarede til farmakokinetikken bestemt i den større population på 120 patienter med forskellige cancerformer.
Breast cancer patients 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/ m2), gennemsnitlig centrale fordelingsvolumen var 1, 46 l/ m2 (interval fra 1, 10 – 1, 64 l/ m2).
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/ m2 (range 1.10 - 1.64 l/ m2).
Gennemsnitlig tilsyneladende halveringstid var 71, 5 timer (interval fra 45, 2 – 98, 5 timer).
The mean apparent half-life was 71.5 hours (range 45.2 - 98.5 hours).
22 Ovariecancerpatienter Farmakokinetikken af Caelyx bestemt i 11 patienter med ovariecarcinom var lig farmakokinetikken bestemt i en større population på 120 patienter med forskellige cancerformer.
Ovarian cancer patients 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.
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/ m2 (interval fra 1, 67 – 2, 40 liter/ m2).
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/ m2 (range 1.67 – 2.40 l/ m2).
Den gennemsnitlige tilsyneladende halveringstid var 75, 0 timer (interval fra 36, 1 - 125 timer).
The mean apparent half-life was 75.0 hours (range 36.1 – 125 hours).
AIDS- KS patienter De farmakokinetiske forhold i plasma for Caelyx blev undersøgt hos 23 patienter med KS, der modtog engangsdoser på 20 mg/ m2, indgivet som en 30 minutters infusion.
22 AIDS-KS patients The plasma pharmacokinetics of Caelyx were evaluated in 23 patients with KS who received single doses of 20 mg/ m2 administered by a 30-minute infusion.
De farmakokinetiske parametre for Caelyx (primært udgørende pegyleret liposomal doxorubicinhydrochlorid og lave niveauer af uindkapslet doxorubicin hydrochlorid), målt efter doserne på 20 mg/ m2 er angivet i tabel 8.
The pharmacokinetic parameters of Caelyx (primarily representing pegylated liposomal doxorubicin hydrochloride and low levels of unencapsulated doxorubicin hydrochloride) observed after the 20 mg/ m2 doses are presented in Table 8.
Farmakokinetiske parametre i Caelyx- behandlede AIDS- KS patienter
Pharmacokinetic Parameters in Caelyx-Treated AIDS-KS
Gennemsnit + Standardafvigelse
Mean + Standard Error
Maksimal Plasmakoncentration * (µg/ ml) Plasma- clearance (liter/ time/ m2) Distributionsvolumen (liter/ m2) AUC (µg/ ml⋅time) λ1 halveringstid (timer) λ2 halveringstid (timer) * Målt ved afslutningen af en 30 minutters infusion
Plasma Clearance (l/ h/ m2) Volume of Distribution (l/ m2) AUC (µg/ ml⋅ h) λ 1 half-life (hours) λ 2 half-life (hours) *Measured at the end of a 30-minute infusion
Kardiotoksicitet:
Cardiotoxicity:
Dermal toksicitet:
Dermal toxicity:
4. 8).
Similar dermal lesions, which are described as palmar-plantar erythrodysesthesia were also observed in patients after long-term intravenous infusion (see section 4.8).
Anafylaktisk reaktion:
Anaphylactoid response:
Under flerdosis- toksikologiske undersøgelser hos hunde iagttog man en akut respons efter indgift af pegylerede liposomer (placebo), der karakteriseredes af hypotension, blege slimhinder, spytafsondring, emesis og perioder med hyperaktivitet fulgt af hypoaktivitet og letargi.
During repeat dose toxicology studies in dogs, an acute response characterised by hypotension, pale mucous membranes, salivation, emesis and periods of hyperactivity followed by hypoactivity and lethargy was observed following administration of pegylated liposomes (placebo).
En lignende, men mindre udtalt respons, forekom også hos hunde, der behandledes med Caelyx og standard doxorubicin.
A similar, but less severe response was also noted in dogs treated with Caelyx and standard doxorubicin.
Reponsen var imidlertid ikke livstruende, og hundene kom sig hurtigt efter behandlingens ophør.
However, the response was not life-threatening and the dogs recovered quickly upon discontinuation of treatment.
Lokal toksicitet:
Local toxicity:
23 Mutagenicitet og karcinogenicitet:
23 Reproductive toxicity:
Caelyx resulterede i let til moderat ovarie og testis atrofi i mus efter en enkelt dosis på 36 mg/ kg.
Caelyx resulted in mild to moderate ovarian and testicular atrophy in mice after a single dose of 36 mg/ kg.
4. 6).
Decreased testicular weights and hypospermia were present in rats after repeat doses ≥ 0.25 mg/ 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).
Nefrotoksicitet:
Nephrotoxicity:
Da en vurdering af post- marketing sikkerhedsdatabasen for Caelyx hos patienter ikke har tydet på en signifikant tilbøjelighed til nefrotoksicitet ved Caelyx, vil disse fund hos aber måske ikke have relevans for vurdering af patientrisiko.
Since an evaluation of the post-marketing safety database for Caelyx in patients has not suggested a significant nephrotoxicity liability of Caelyx, these findings in monkeys may not have relevance to patient risk assessment.
α - (2 - [1, 2- distearoyl- sn- glycero( 3) phosphooxy] ethylcarbamoyl) - ω- methoxypoly( oxyethylen) - 40 natriumsalt (MPEG- DSPE) helhydrogeneret sojafosfatidylcholin (HSPC) kolesterol ammoniumsulfat saccharose histidin vand til injektionsvæsker saltsyre natriumhydroxid.
α -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-ω -methoxypoly(oxyethylen)- 40 sodium salt (MPEG-DSPE) fully hydrogenated soy phosphatidylcholine (HSPC) cholesterol ammonium sulphate sucrose histidine water for injections hydrochloric acid sodium hydroxide
- 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.
- Fra et mikrobiologisk synspunkt skal præparatet anvendes straks.
- From a microbiological point of view, the product should be used immediately.
Hvis det ikke anvendes
If not used
straks, er opbevaringstider og - betingelser før anvendelse brugerens ansvar og skal normalt ikke være længere end 24 timer ved 2°C - 8°C.
immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
- Delvis brugte hætteglas skal bortkastes.
- Partially used vials must be discarded.
24 Type 1 hætteglas med en silikoneret, grå bromobutylprop og et aluminiumssegl, med et anvendeligt volumen på 10 ml (20 mg) eller 25 ml (50 mg).
Type I glass vials, each with a siliconised grey bromobutyl stopper, and an aluminium seal, with a deliverable volume of 10 ml (20 mg) or 25 ml (50 mg).
Der skal udvises forsigtighed ved håndtering af Caelyx- opløsningen.
Caution must be exercised in handling Caelyx solution.
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).
Den rette dosis af Caelyx skal fortyndes i 5% (50 mg/ ml) glukose infusionsvæske før indgivelse.
The appropriate dose of Caelyx must be diluted in 5% (50 mg/ ml) glucose solution for infusion prior to administration.
For doser < 90 mg, fortyndes Caelyx i 250 ml, og for doser ≥ 90 mg, fortyndes Caelyx i 500 ml.
For doses < 90 mg, dilute Caelyx in 250 ml, and for doses ≥ 90 mg, dilute Caelyx in 500 ml.
4. 2.
This can be infused over 60 or 90 minutes as detailed in 4.2.
Anvendelse af andet opløsningsmiddel end 5% (50 mg/ ml) glukose infusionsvæske eller tilstedeværelse af bakteriostatiske stoffer som f. eks. benzylalkohol kan forårsage bundfældning af Caelyx.
The use of any diluent other than 5% (50 mg/ ml) glucose solution for infusion, or the presence of any bacteriostatic agent such as benzyl alcohol may cause precipitation of Caelyx.
Det anbefales at sætte Caelyx- infusionsslangen som sidedrop til en intravenøs infusion med 5% (50 mg/ ml) glukose.
It is recommended that the Caelyx infusion line be connected through the side port of an intravenous infusion of 5% (50 mg/ ml) glucose.
Må ikke anvendes sammen med in- line filtre.
Do not use with in-line filters.
SP Europe Rue de Stalle 73 B - 1180 Bruxelles Belgien
SP Europe Rue de Stalle 73 B – 1180 Bruxelles Belgium
Dato for første tilladelse:
Date of first authorization:
21. juni 1996 Dato for seneste fornyelse:
21 June 1996 Date of last renewal:
25 Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
25 ANNEX II
26 BILAG II
26 A.
SP Labo, Industriepark 30, 2220, Heist- op- den- Berg, Belgien
SP Labo N. V., Industriepark 30, 2220, Heist-op-den-Berg, Belgium
Pharmacovigilance system Markedsføringsindehaveren skal sikre, at det pharmacovigilancesystem, som er beskrevet i ansøgningen om markedsføringstilladelse Module 1. 8. 1 og dateret juni 2007, er implementeret og i funktion, før og mens produktet er på markedet.
Pharmacovigilance system The MAH must ensure that the system of Pharmacovigilance, as described in version dated June 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the Market.
Risikostyringsprogram Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de kliniske undersøgelser og yderligere pharmacovigilanceaktiviteter, som er angivet i pharmacovigilanceplanen, som aftalt i Risk Management Planen (RMP) dateret 1 juni 2007, som findes i modul 1. 8. 2. i ansøgningen om markedsføringstilladelse, og enhver efterfølgende opdatering af RMP efter aftale med CHMP.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version dated 01 June 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
I henhold til CHMP- guideline om risk- management- systemer for lægemidler til human brug skal den opdaterede RMP indsendes på samme tid som den næste periodiske sikkerhedsopdatering (PSUR).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Derudover skal en opdateret RMP indsendes: • Når der modtages ny information, som kan påvirke den gældende sikkerhedsspecifikation, pharmacovigilanceplan, eller de igangværende og planlagte risikominimeringsaktiviteter • Inden 60 dage efter en væsentlig (pharmacovigilance - eller risikominimerings -) milepæl er nået • På anmodning fra EMEA
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
28 BILAG III
28 A.
ETIKETTERING
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
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 2 mg/ ml koncentrat til infusionsvæske, opløsning Pegyleret liposomal doxorubicinhydrochlorid
Caelyx 2 mg/ ml concentrate for solution for infusion Pegylated liposomal doxorubicin hydrochloride
Hjælpestoffer: α - (2 - [1, 2- distearoyl- sn- glycero( 3) phosphooxy] ethylcarbamoyl) - ω - methoxypoly( oxyethylen) - 40 natriumsalt, helhydrogeneret sojafosfatidylcholin, kolesterol, ammoniumsulfat, saccharose, histidin, vand til injektion, saltsyre og natriumhydroxid.
Excipients: α -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-ϖ - methoxypoly(oxyethylen)-40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.
1 hætteglas 10 hætteglas 20 mg/ 10 ml
1 vial 10 vials 20 mg/ 10 ml
Intravenøs anvendelse, efter fortynding med 5% (50 mg/ ml) glukose infusionsvæske.
Intravenous use, following dilution in 5% (50 mg/ ml) glucose solution for infusion.
31 Opbevares i køleskab.
Store in a refrigerator.
Caelyx bør håndteres og bortskaffes i henhold til retningslinierne for håndtering af andre cytostatiske lægemidler.
Caelyx should be handled and disposed of in a manner consistent with that of other cytotoxic medicinal products.
SP Europe Rue de Stalle 73 B- 1180 Bruxelles, Belgien
SP Europe Rue de Stalle 73 B-1180 Bruxelles Belgium
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)
32 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
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
Caelyx 2 mg/ ml koncentrat til infusionsvæske, opløsning Pegyleret liposomal doxorubicin hydrochlorid
Caelyx 2 mg/ ml concentrate for solution for infusion Pegylated liposomal doxorubicin hydrochloride
1 hætteglas 10 hætteglas 50 mg/ 25 ml
1 vial 10 vials 50 mg/ 25 ml
33 Opbevares i køleskab.
Store in a refrigerator.
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)
34 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
CAELYX ETIKET 20 mg/ 10 ml
CAELYX LABEL 20 mg/ 10 ml
35 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
CAELYX ETIKET 50 mg/ 25 ml
CAELYX LABEL 50 mg/ 25 ml
INDLÆGSSEDDEL
36 PACKAGE LEAFLET:
- Lægen har ordineret Caelyx til Dem personligt.
- This medicine has been prescribed for you.
Caelyxs virkning og hvad De skal bruge det til 2.
What Caelyx is and what it is used for 2.
Det skal De vide, før De begynder at bruge Caelyx 3.
Before you use Caelyx 3.
Sådan skal De bruge Caelyx 4.
How to use Caelyx 4.
Sådan opbevarer De Caelyx 6.
Possible side effects 5 How to store Caelyx 6.
CAELYXS VIRKNING OG HVAD DE SKAL BRUGE DET TIL
WHAT CAELYX IS AND WHAT IT IS USED FOR
Caelyx er et lægemiddel mod tumorer/ svulster.
Caelyx is an antitumour agent.
Caelyx anvendes også i kombination med et andet lægemiddel, bortezomib, til behandling af multipelt myelom, en kræfttype, der kan forekomme i blodet hos patienter, der har modtaget 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.
Caelyx anvendes også til at give en forbedring af Deres Kaposis sarkom blandt andet ved lindring, lettelse og endog formindskelse af canceren.
Caelyx is also used to produce an improvement in your Kaposi’ s sarcoma including flattening, lightening and even shrinkage of the cancer.
Andre symptomer på Kaposis sarkom, såsom hævelse omkring tumor, kan også forbedres eller forsvinde.
Other symptoms of Kaposi’ s sarcoma, such as swelling around the tumour, may also improve or disappear.
DET SKAL DE VIDE, FØR DE BEGYNDER AT BRUGE CAELYX
BEFORE YOU USE CAELYX
Brug ikke Caelyx
Do not use Caelyx
- hvis De er overfølsom (allergisk) over for doxorubicinhydrochlorid eller et af de øvrige
- if you are allergic (hypersensitive) to doxorubicin hydrochloride or any of the other ingredients
indholdsstoffer.
of Caelyx.
Vær ekstra forsigtig med at bruge Caelyx
Take special care with Caelyx
- hvis De modtager nogen form for behandling af hjerte - eller leversygdom;
- if you are receiving any treatment for heart disease or liver disease;
- hvis De har sukkersyge, idet Caelyx indeholder sukker og nødvendiggør en ændring af Deres
- if you are diabetic, because Caelyx contains sugar which may require an adjustment to the
sukkersygebehandling;
treatment of your diabetes;
- hvis De har Kaposis sarkom, og De har fået fjernet Deres milt.
- if you have Kaposi’ s sarcoma and have had your spleen removed.
Brug af anden medicin
Taking other medicines Please tell your doctor or pharmacist
38 Fortæl det altid til lægen eller apoteket
37
Dette gælder også medicin, som ikke
- if you are taking or have recently taken any other medicines, including medicines obtained
er købt på recept.
without a prescription,
- om enhver anden medicin mod kræft, De tager eller har taget, idet særlige hensyn skal tages ved
- about any other cancer treatments you are on or have been taking, as particular care needs to be
behandlinger, som reducerer antallet af hvide blodlegemer, da det kan være årsag til yderligere reduktion i antallet af hvide blodlegemer.
taken with treatments which reduce the number of white blood cells, as this may cause further reduction in the number of white blood cells.
Graviditet og amning Spørg Deres læge eller apoteket til råds, inden De tager nogen form for medicin.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Undgå at blive gravid, mens De eller Deres partner er i behandling med Caelyx samt i de første seks måneder efter ophør med Caelyx behandling.
Avoid becoming pregnant while you or your partner are taking Caelyx and in the six months following discontinuation of Caelyx treatment.
Da det aktive stof doxorubicinhydrochlorid i Caelyx kan være skadeligt for diende børn, skal kvinder ophøre med amning før start af behandling med Caelyx.
Because doxorubicin hydrochloride may be harmful to nursing infants, women must discontinue breast-feeding before starting treatment with Caelyx.
Trafik - og arbejdssikkerhed Kør ikke bil og betjen ikke værktøj eller maskiner, hvis De føler Dem træt eller søvnig af behandling med Caelyx.
Driving and using machines Do not drive or use any tools or machines if you feel tired or sleepy from treatment with Caelyx.
SÅDAN SKAL DE BRUGE CAELYX
HOW TO USE CAELYX
Det må ikke ombyttes med andre formuleringer af doxorubicin hydrochlorid.
It must not be used interchangeably with other formulations of doxorubicin hydrochloride.
Caelyx vil blive givet af Deres læge direkte ind i en vene gennem et drop (kaldet infusion).
Caelyx will be given to you by your doctor in a drip (infusion) into a vein.
Afhængig af dosen og indikationen kan dette tage fra 30 minutter til over en time (eksempelvis 90 minutter).
Depending on the dose and indication, this may take from 30 minutes to more than one hour (i. e., 90 minutes).
Caelyx gives straks efter bortezomibinfusionen som en 1- times intravenøs infusion på Dag 4 i 3- ugers behandlingen.
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.
Hvis De behandles for Kaposis sarkom, vil Caelyx blive givet i en dosis på 20 mg per kvadratmeter af Deres legemsoverfladeareal (baseret på Deres højde og vægt).
If you are being treated for Kaposi’ sarcoma, Caelyx will be administered at a dose of 20 mg per square metre of your body surface area (based on your height and weight).
Dosis gentages hver 2. til 3. uge i 2 - 3 måneder og herefter så hyppigt, som det er nødvendigt for at opretholde en bedring i Deres tilstand.
The dose is repeated every 2 to 3 weeks for 2 - 3 months, then as often as necessary to maintain an improvement in your condition.
Hvis De har taget for meget Caelyx Akut overdosering forværrer bivirkninger som sår i munden eller fald i antallet af hvide blodlegemer og blodplader i blodet.
If you use more Caelyx than you should Acute overdosing worsens side effects like sores in the mouth or decreases the number of white blood cells and platelets in the blood.
Caelyx kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Caelyx can cause side effects, although not everybody gets them.
Rødme i ansigtet, åndenød, hovedpine, kulderystelser, rygsmerter, sammensnøring af brystet og/ eller halsen, ondt i halsen, lavt blodtryk eller stigning i blodtrykket, hurtige hjerteslag, opsvulmen af ansigtet, feber, svimmelhed, kvalme, dårlig fordøjelse, kløe, udslæt og svedtendens.
38 During the infusion of Caelyx, the following reactions may occur: flushing of the face, shortness of breath, headache, chills, back pain, tightness in the chest and/ or throat, sore throat, low or increase in blood pressure, rapid heart beat, puffing of the face, fever, dizziness, nausea, indigestion, itching, rash and sweating.
Svien eller opsvulmen på injektionsstedet kan også forekomme.
In very rare cases, seizures (convulsions) have occurredStinging or swelling of the skin at the site of injection may also occur.
- De oplever en smertefuld rødme af huden på Deres hænder og fødder,
- you get reddening painful skin on your hands and feet,
- De oplever en smertefuld rødme af huden og/ eller blister på kroppen eller i munden,
- you get painful reddening of the skin and/ or blisters on the body or in the mouth,
- De får hjerteproblemer,
- you get heart problems,
- De får mundsår,
- you get mouth sores,
- De får feber eller andre tegn på infektion,
- you develop a fever or any other sign of an infection,
- De får pludselig kortåndethed eller skarpe brystsmerter, som kan forværres ved dybe
- you get sudden shortness of breath or sharp chest pain that may worsen with deep breathing or
indåndinger eller hoste,
coughing,
- De får hævelse, varme eller ømhed i det bløde væv på Deres ben, nogle gange med smerter, der
- you get swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain
bliver værre, når De står eller går.
which gets worse when you stand or walk.
- rødmen, hævelse og sår i håndfladerne og under fødderne.
- redness, swelling and sores on the palms of your hands and feet.
Disse reaktioner er set hyppigt, og er
These effects have been seen
sommetider alvorlige.
frequently, and are sometimes severe.
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);
- smerte eller sår i mund og hals, kvalme, opkastning, mavesmerter, diarré, forstoppelse, trøske i
- pain or sores in mouth or throat, nausea, vomiting, stomach pains, diarrhoea, constipation, oral
munden (en svampeinfektion i munden), sår i næsen, blødning fra næsen, forkølelsessår, tab af appetitten, vægttab og betændelse i tungen;
thrush (a fungal infection in the mouth), sores in nose, bleeding from your nose, cold sores, loss of appetite, weight loss and tongue inflammation;
Anæmi
- decrease in the number of white blood cells, which can increase the chances of infections.