qanastek/EMEA-V3 huggingface dataset:
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.
Pjan ta ’ Immaniġġjar tar- Riskju L- MAH jintrabat li jwettaq l- istudji u l- attivitajiet l- oħra ta ’ farmakoviġilanza hekk kif huma dettajlati fil- Pjan ta ’ Farmakoviġilanza, kif miftihem fil- verżjoni datata 01 Ġunju 2007 tal- Pjan ta ’ l - Immaniġġjar tar- Riskju (RMP) preżentat f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornamenti li jsiru wara mill- RMP mifthema mis- CHMP.
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).
Skond il- Linja Gwida tas- CHMP dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu fil- bniedem, l- RMP aornat għandu jiġi sottomess fl- istess ħin mar- Rapport Perijodiku Aġġornat dwar is- Sigurtà (PSUR) li jkun imiss.
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
Minbarra hekk, RMP aġġornat għandu jiġi sottomess • Meta jinkiseb tagħrif ġdid li jista ’ jkollu xi impatt fuq l- Ispeċifikazzjoni tas- Sigurtà kurrenti, Pjan ta ’ Farmakoviġilianza jew attivitajiet li jnaqqsu r- riskju. • Fi żmien 60 jum minn meta tintlaħaq xi ġrajja importanti (ta ’ farmakoviġilanza jew tnaqqis tar- riskju) • Fuq talba ta ’ l- EMEA
28 A.
28 ANNESS III
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
CAELYX CARTON 20 mg/ 10 ml – 1 vial CAELYX CARTON 20 mg/ 10 ml – 10 vials
CAELYX KARTUNA 20 mg/ 10 ml – kunjett 1 CAELYX KARTUNA 20 mg/ 10 ml – 10 kunjetti
Caelyx 2 mg/ ml concentrate for solution for infusion Pegylated liposomal doxorubicin hydrochloride
Caelyx 2 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Doxorubicin hydrochlorinated liposomali pegilat
One ml of Caelyx contains 2 mg pegylated liposomal doxorubicin hydrochloride.
ml ta ’ Caelyx fih 2 mg doxorubicin hydrochlorinated liposomali pegilat.
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.
Sustanzi mhux attivi: α - (2 - [1, 2- distearoyl - sn- glycero( 3) phosphoxy] ethylcarbamoyl) - ϖ- methoxypoly (oxyethylen) - 40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, ilma għall- injezzjonijiet, hydrochloric acid u sodium hydroxide.
1 vial 10 vials 20 mg/ 10 ml
kunjett 1 10 kunjetti 20 mg/ 10 ml
Intravenous use, following dilution in 5% (50 mg/ ml) glucose solution for infusion.
Użu għal ġol vini, wara li jkun dilwit f' 5% (50 mg/ ml) soluzzjoni tal- glucose għall- infużjoni.
Read the package leaflet before use.
Aqra l- fuljetta ta 'tagħrif qabel l- użu.
DO NOT USE INTERCHANGEABLY WITH OTHER FORMULATIONS OF DOXORUBICIN HYDROCHLORIDE.
TIBDLUX MA 'FORMULAZZJONIJIET OĦRAJN TA' DOXORUBICIN HYDROCHLORIDE.
Store in a refrigerator.
31 Aħżen fi friġġ.
Partially used vials should be discarded.
Kunjetti wżati mhux għal kollox għandhom jintremew.
Caelyx should be handled and disposed of in a manner consistent with that of other cytotoxic medicinal products.
Caelyx għandu jintuża u jintrema b' mod konsistenti ma 'dak ta' prodotti mediċinali ċitotossiċi oħrajn.
SP Europe Rue de Stalle 73 B-1180 Bruxelles Belgium
SP Europe Rue de Stalle 73 B- 1180 Bruxelles Il- Belġju
EU/ 1/ 96/ 011/ 001 (1 vial) EU/ 1/ 96/ 011/ 002 (10 vials)
EU/ 1/ 96/ 011/ 001 (kunjett 1) EU/ 1/ 96/ 011/ 002 (10 kunjetti)
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTA TA ’ BARRA JEW
CAELYX CARTON 50 mg/ 25 ml – 1 vial CAELYX CARTON 50 mg/ 25 ml – 10 vials
KARTUNA CAELYX 50 mg/ 25 ml – kunjett 1 KARTUNA CAELYX 50 mg/ 25 ml – 10 kunjett
One ml of Caelyx contains 2 mg pegylated liposomal doxorubicin hydrochloride.
ml wieħed ta ’ Caelyx fih 2 mg doxorubicin hydrochlorinated liposomali pegilat.
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.
Sustanzi mhux attivi: 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, ilma għall- injezzjonijiet, hydrochloric acid u sodium hydroxide.
1 vial 10 vials 50 mg/ 25 ml
kunjett 1 10 kunjetti 50 mg/ 25 ml
Read the package leaflet before use.
Aqra l- fuljett ta 'tagħrif qabel l- użu.
DO NOT USE INTERCHANGEABLY WITH OTHER FORMULATIONS OF DOXORUBICIN HYDROCHLORIDE.
TIBDLUX MA 'FORMULAZZJONIJIET OĦRAJN TA ’ DOXORUBICIN HYDROCHLORIDE.
Store in a refrigerator.
33 Aħżen fi friġġ.
SP Europe Rue de Stalle 73 B-1180 Bruxelles Belgium
SP Europe Rue de Stalle 73 B - 1180 Bruxelles Il- Belġju
EU/ 1/ 96/ 011/ 003 (1 vial) EU/ 1/ 96/ 011/ 004 (10 vials)
EU/ 1/ 96/ 011/ 003 (kunjett 1) EU/ 1/ 96/ 011/ 004 (10 kinjetti)
33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CAELYX LABEL 20 mg/ 10 ml
TIKKETTA CAELYX 20 mg/ 10 ml
Intravenous use
Użu għal ġol vini
34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
35 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CAELYX LABEL 50 mg/ 25 ml
TIKKETTA CAELYX 50 mg/ 25 ml
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan- il fuljett kollu qabel tibda tuża din il- mediċina.
It may harm them, even
Tista 'tagħmlilhom
What Caelyx is and what it is used for 2.
X' inhu Caelyx u għalxiex jintuża 2.
Before you use Caelyx 3.
Qabel ma tuża Caelyx 3.
How to use Caelyx 4.
Kif għandek tuża Caelyx 4.
Possible side effects 5 How to store Caelyx 6.
Effetti sekondarji li jista 'jkollu 5.
Further information
Kif taħżen Caelyx 6.
WHAT CAELYX IS AND WHAT IT IS USED FOR
X’ INHU CAELYX U GĦALXIEX JINTUŻA
Caelyx is an antitumour agent.
Caelyx huwa sustanza kontra t- tumur.
Caelyx is used to treat cancer of the breast in patients at risk for heart problems.
Caelyx jintuża għat- trattament ta 'kanċer tas- sider f' pazjenti b' riskju ta' problemi tal- qalb.
Caelyx is also used to treat cancer of the ovary.
Caelyx jintuża wkoll għat- trattament ta 'kanċer ta' l- ovarji.
It is used to kill cancer cells, shrink the size of the tumour, delay the growth of the tumour, and extend your survival.
Jintuża biex joqtol iċ- ċelluli tal- kanċer, biex iċekken it- tumur fid- daqs, biex jittardja t- tkabbir tat- tumur u biex itawwallek iż- żmien kemm iddum ħaj.
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 jintuża wkoll kombinat ma ’ mediċina oħra, bortezomib, għal kura ta ’ majeloma multipla, tumur tad- demm, f’ pazjenti li rċevew mill- anqas terapija 1 minn qabel.
Caelyx is also used to produce an improvement in your Kaposi’ s sarcoma including flattening, lightening and even shrinkage of the cancer.
Caelyx jintuża wkoll biex itejjeb is- sarkoma ta 'Kaposi tiegħek inkluż biex il- kanċer jiċċattja, jeħfief jew saħansitra biex jinxtorob.
Other symptoms of Kaposi’ s sarcoma, such as swelling around the tumour, may also improve or disappear.
Sintomi oħra tas- sarkoma ta 'Kaposi bħal nefħa madwar it- tumur, jistgħu jiġu għall- aħjar jew igħibu.
Caelyx contains a medicine which is able to interact with cells in such a way as to selectively kill cancer cells.
Caelyx fih mediċina li kapaċi tinteraġixxi maċ- ċelluli b' mod illi toqtol iċ- ċelluli tal- kanċer selettivament.
The doxorubicin hydrochloride in Caelyx is enclosed in tiny spheres called pegylated liposomes which help to deliver the medicinal product from the blood stream to the cancerous tissue rather than healthy normal tissue.
Doxorubicin hydrochloride f’ Caelyx hu maqbud fi sferi zgħar ħafna jisimhom liposomi pegilati li jgħinu biex iwasslu l- prodott mediċinali mid- demm għat- tessut tal- kanċer u mhux f' tessut normali b' saħħtu.
BEFORE YOU USE CAELYX
QABEL MA ’ TUŻA CAELYX
Do not use Caelyx
Tużax Caelyx
- if you are allergic (hypersensitive) to doxorubicin hydrochloride or any of the other ingredients
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal doxorubicin hydrochloride jew
of Caelyx.
sustanzi oħra ta’ Caelyx.
Take special care with Caelyx
Oqgħod attent ħafna bil- Caelyx
- if you are receiving any treatment for heart disease or liver disease;
- jekk qegħda tirċievi kura għall- mard tal- qalb jew mard tal- fwied;
- if you are diabetic, because Caelyx contains sugar which may require an adjustment to the
- jekk inti dijabetika, peress li Caelyx fih iz- zokkor li jista 'jkun jeħtieġ tibdil fil- kura tad- dijabete
treatment of your diabetes;
tiegħek;
- if you have Kaposi’ s sarcoma and have had your spleen removed.
- jekk għandek sarkoma ta 'Kaposi u neħħewlek il- milsa.
Taking other medicines Please tell your doctor or pharmacist
Meta tuża mediċini oħra
- if you are taking or have recently taken any other medicines, including medicines obtained
38 Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek
without a prescription,
- jekk qiegħed tieħu jew hadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta
- about any other cancer treatments you are on or have been taking, as particular care needs to be
- dwar xi trattamenti oħrajn kontra l- kanċer li qed tieħu jew li kont qed tieħu, peress li għandha
taken with treatments which reduce the number of white blood cells, as this may cause further reduction in the number of white blood cells.
tingħata attenzjoni partikolari għall- dawk it- trattament li jnaqqsu n- numru ta ’ ċelloli bojod tad - demm, għax din tista ’ twassal għal aktar tnaqqis fin- numru ta ’ ċelloli bojod tad- demm.
If you are unsure about what treatments you have received or any illnesses you have had, discuss these with your doctor.
Jekk m’ intix ċert( a) dwar liema trattamenti ingħatajt jew mard li kellek, iddiskutihom mat- tabib tiegħek.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Tqala u treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Because the active ingredient doxorubicin hydrochloride in Caelyx may cause birth defects, it is important to tell your doctor if you think you are pregnant.
Minħabba li s- sustanza attiva doxorubicin hydrochloride f’ Caelyx tista 'tikkawża difetti tat- twelid, huwa importanti li tgħid lit- tabib jekk taħseb li inti ħriġt tqila.
Avoid becoming pregnant while you or your partner are taking Caelyx and in the six months following discontinuation of Caelyx treatment.
Evita li toħroġ tqila waqt li int jew sieħbek tkunu qed tieħdu Caelyx u għal sitt xhur wara li tieqfu tieħdu trattament b’ Caelyx.
Because doxorubicin hydrochloride may be harmful to nursing infants, women must discontinue breast-feeding before starting treatment with Caelyx.
Peress li doxorubicin hydrochloride jista 'jkun ta' ħsara għal trabi li jkunu mreddgħa, in- nisa għandhom jieqfu milli jreddgħu qabel ma jibdew trattament b’ Caelyx.
Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
L- esperti tas- saħħa jirrakkomandaw li nisa bl- HIV ma jreddgħux lit- trabi tagħhom taħt kwalunkwe ċirkostanza biex jevitaw li jgħaddu l- HIV.
Driving and using machines Do not drive or use any tools or machines if you feel tired or sleepy from treatment with Caelyx.
Sewqan u tħaddim ta ’ magni M' għandekx issuq jew tagħmel użu minn għodda jew tħaddem magni jekk tħoss għejja jew ngħas waqt it- trattament b’ Caelyx.
HOW TO USE CAELYX
KIF GĦANDEK TUŻA CAELYX
Caelyx is a unique formulation.
Caelyx hija formulazzjoni unika.
It must not be used interchangeably with other formulations of doxorubicin hydrochloride.
M' għandhiex tintuża b' mod li tinbidel ma 'formulazzjonijiet oħra ta' doxorubicin hydrochloride.
Caelyx will be given to you by your doctor in a drip (infusion) into a vein.
Caelyx ser jingħatalek mit- tabib tiegħek fi dripp (infużjoni) ġol- vina.
Depending on the dose and indication, this may take from 30 minutes to more than one hour (i. e., 90 minutes).
Skond id- doża u l- indikazzjoni, din tista ’ ddum minn 30 minuta sa aktar minn siegħa (90 minuta).
If you are being treated for breast cancer or ovarian cancer, Caelyx will be administered at a dose of 50 mg per square metre of your body surface area (based on your height and weight).
Jekk qed tieħu trattament għal kanċer tas- sider jew ta 'l- ovarji, Caelyx jingħatalek f' dożi ta' 50 mg għal kull metru qwadru ta ’ l- erja tas- superfiċje ta 'ġismek (skond it- tul u l- piż tiegħek).
The dose is repeated every 4 weeks for as long as the disease does not progress and you are able to tolerate the treatment.
Id- doża terġa 'tiġi ripetuta kull 4 ġimgħat sakemm il- marda ma tibqax tinfirex u sakemm int tkun tista' tittollera t - trattament.
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.
Jekk qed tieħu t- trattament għal majeloma multipla, u diġa rċevejt mill- anqas terapija waħda minn qabel, Caelyx ser jingħatalek b’ doża ta ’ 30 mg għal kull metru kwadru ta ’ ġismek (ibbażat mit- tul u l - piż tiegħek) bħala infużjoni ġol- vina ta ’ siegħa f’ Jum 4 ta ’ ġimgħa 3 tar- reġimen b’ bortezomib, immedjatament wara l- infużjoni b’ bortezomib.
The dose is repeated as long as you respond satisfactorily and tolerate treatment.
Id- doża tiġi ripetuta sakemm ikollok rispons sodisfaċjenti u tkun tiflaħ għat- trattament.
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).
Jekk qed tieħu t- trattament għal sarkoma ta 'Kaposi, Caelyx jingħatalek f' doża ta' 20 mg kull metru kwadru tal- wiċċ ta ’ l- erja tas- superfiċje ta ’ ġismek (bażata fuq it- tul u l- piż tiegħek).
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.
Id- doża terġa 'tiġi ripetuta kull 2 jew 3 ġimgħat għal 2 jew 3 xhur, imbagħad ta ’ spiss kemm ikun hemm bżonn biex jinżamm it- titjib tal- kundizzjoni tiegħek.
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.
Jekk tieħu Caelyx aktar milli suppost Doża eċċessiva akuta tħarrax effetti sekondarji bħal selħiet fil- ħalq, tnaqqas fin- numru ta 'ċelluli bojod jew plejtlets fid- demm.
Treatment will include administration of antibiotics, platelet cell transfusions, use of factors which stimulate production of white blood cells and symptomatic treatment of mouth sores.
It- trattament ikun jinkludi li tingħata antibijotiċi, trasfużjoni ta 'ċelluli plejtlets, użu ta' fatturi li jistimolaw il- produzzjoni ta 'ċelluli bojod u trattament sintomatiku tas- selħiet fil- ħalq.
Like all medicines, Caelyx can cause side effects, although not everybody gets them.
39 Bħal kull mediċina oħra, Caelyx jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
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.
Waqt l- infużjoni ta’ Caelyx jistgħu jseħħu r- reazzjonijiet li ġejjin: fawriet fil- wiċċ, qtugħ ta 'nifs, uġigħ ta ’ ras, dehxiet, uġigħ fid- dahar, tagħfis fis- sider u/ jew fil- griżmejn, selħiet fil- grizmejn, pressjoni għolja jew pressjoni baxxa, qalb tħabbat malajr, nefħa fil- wiċċ, deni, sturdament, tqallih, indiġestjoni, ħakk, raxx u għaraq.
In very rare cases, seizures (convulsions) have occurredStinging or swelling of the skin at the site of injection may also occur.
Tingiż jew nefħa mnejn tingħata l- injezzjoni jistgħu jseħħu wkoll.
If the drip stings or hurts while you are receiving a dose of Caelyx, tell your doctor immediately.
Jekk id- dripp tniggżek jew tweġġgħek waqt li qed tieħu d- doża ta’ Caelyx, għarraf lit- tabib minnufih.
Contact your doctor immediately if:
Għarraf minnufih lit- tabib tiegħek jekk:
- you get reddening painful skin on your hands and feet,
- ikollok uġigħ u ħmura tal- ġilda f’ idejk u saqajk,
- you get painful reddening of the skin and/ or blisters on the body or in the mouth,
- ikollok ħmura b’ uġigħ tal- ġilda u/ jew infafet ma ’ ġismek jew f’ ħalqek,
- you get heart problems,
- jaqbduk problemi tal- qalb,
- you get mouth sores,
- jaqbduk xi selħiet f' ħalqek,
- you develop a fever or any other sign of an infection,
- jaqbdek id- deni jew xi sinjal ieħor ta 'infezzjoni,
- you get sudden shortness of breath or sharp chest pain that may worsen with deep breathing or
- jaqbdek qtugħ ta ’ nifs f’ daqqa jew uġigħ f’ sidrek li jista ’ jaggrava meta tieħu nifs fil- fond jew
coughing,
tisgħol,
- you get swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain
- it- tessuti rotob ta ’ saqajk jintefħu jisħnu jew isiru teneri, kultant b’ uġigħ li jaggrava meta tkun
which gets worse when you stand or walk.
bil- wieqfa jew timxi.
Between infusions, the following may occur:
Bejn infużjoni u oħra jista 'jiġri dan li ġej:
- redness, swelling and sores on the palms of your hands and feet.
- ħmura, nefħa u selħiet fil- pali ta 'jdejk u ta ’ saqajk.
These effects have been seen
Dawn l- effetti rawhom ta 'spiss u xi kultant
frequently, and are sometimes severe.
ikunu qawwija.
In severe cases, these effects may interfere with certain daily activities, and may last for 4 weeks or longer before resolving completely.
F' każijiet serji, dawn l- effetti jistgħu jtellfu f' ċerti attivitajiet ta 'kuljum u jistgħu jdumu għal 4 ġimgħat jew aktar qabel ma jmorru għal kollox.
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);
It- tabib jista 'jkun irid jittardja l - bidu u/ jew inaqqas id- doża tat- trattament li jmiss (ara Strateġiji biex tevita u tikkura s- sindrome ta' l- id- sieq, hawn isfel);
- pain or sores in mouth or throat, nausea, vomiting, stomach pains, diarrhoea, constipation, oral
- uġigħ jew selħiet fil- ħalq jew fil- grizmejn, tqallih, rimettar, uġigħ fl- istonku, dijarrea, stitikezza,
thrush (a fungal infection in the mouth), sores in nose, bleeding from your nose, cold sores, loss of appetite, weight loss and tongue inflammation;
traxx orali (infezzjoni ta 'moffa fil- ħalq), selħiet fl- imnieħer, fsada (tinfaraġ), qsim tax- xofftejn, telf ta ’ l- aptit, tnaqqis fil- piż u infjammazzjoni ta' l- ilsien;
- decrease in the number of white blood cells, which can increase the chances of infections.
Anemija
Anaemia (reduction in red blood cells) may cause tiredness, and decreased platelets in the blood may increase the risk of bleeding.
(tnaqqis fin- numru ta 'ċelluli ħomor fid- demm) tista' tikkawża għajja u t- tnaqqis tal- plejtlets fid - demm jista 'jżid ir- riskju ta' fsada.
In rare cases, having low white blood cells may lead to severe infection.
F' każi rari, livell baxx ta 'ċelluli bojod fid- demm jista' jwassal għal infezzjoni qawwija.
Laboratory values related to the function of the liver may either increase or decrease while on Caelyx.
Il- valuri tal- laboratorju relatati mal- funzjoni tal- fwied jistgħu jogħlew jew jonqsu waqt li tkun fuq Caelyx.
It is because of the potential changes in your blood cells that you will have regular blood tests.
Huwa minħabba l- possibiltà ta 'tibdil fiċ- ċelluli tad- demm tiegħek li jagħmlulek testijiet tad- demm regolari.
From a clinical study in patients with AIDS-KS comparing Caelyx against another treatment (bleomycin/ vincristine), there may be a higher chance of some infections with Caelyx.
Minn studju kliniku f' pazjenti bl- AIDS- KS li jqabbel Caelyx ma 'trattament ieħor (bleomycin/ vincristine), jista' jkunu hemm ċans akbar ta 'infezzjoni b’ Caelyx.
However, in contrast to the experience with patients with AIDS-KS, when Caelyx was compared to a standard treatment for advanced ovarian cancer (topotecan), the risk of infections was substantially lower in the Caelyx-treated patients.
Madankollu, b' kuntrast ma 'pazjenti bl- AIDS- KS meta Caelyx tqabbel ma' trattament standard għall- kanċer ta 'l- ovarji avvanzat (topotecan) ir- riskju ta' infezzjoni huwa sostanzjalment anqas fost il- pazjenti li ttrattawhom b’ Caelyx.
The risk of low blood counts and infections was similarly low in breast cancer studies.
Ir- riskju ta 'għadd baxx taċ- ċelluli tad- demm u ta' infezzjoniiet kien baxx bl- istess mod fl- istudji dwar il- kanċer tas- sider.
Some of these effects may be related to your disease and not to Caelyx;
X' uħud minn dawn l- effetti jistgħu jkunu marbuta mal- marda tiegħek u mhux ma ’ Caelyx.
- general feeling of tiredness, sleepiness, confusion, dizziness, weakness, bone pain, breast pain,
- sensazzjoni ġenerali ta 'għajja, ngħas, konfużjoni, sturdament, dgħjufija, uġigħ fl- għadam, uġigħ
muscle pain, leg cramps or swelling, general swelling, inflammation of the retina (the light- detecting membrane of the eye), increased tear production, blurred vision, feeling of pins and needles or pain in hands and feet;
fis- sider, uġigħ fil- muskoli, bugħawwieġ fir- riġlejn u nefħa, nefħa ġenerali, infjammazzjoni tar - retina (il- membrana ta ’ l- għajn sensittiva għad- dawl), żieda fil- produzzjoni tad- dmugħ, vista mċajpra, sensazzjoni ta ’ labar u tingiż jew uġigħ fl- idejn u saqajn;
- hair loss, inflammation of hair follicles, scaly skin, inflammation or rash, abnormal skin
- titlef ix- xagħar, infjammazzjoni tal- basla tax- xagħar, ġilda tagħmel il- qxur, infjammazzjoni jew
pigmentation (colouring), and nail disorder;
raxx, lewn tal- ġilda (kulur) anormali u mard tad- dwiefer;
- heart problems, e. g., irregular heart beat, enlarged blood vessels;
- problemi tal- qalb eż. il- qalb tħabbat irregolari, il- vini jintefħu;
- fever, increased temperature or any other sign of infection which may be related to your disease;
- deni, żieda fit- temperatura jew kull sinjal ieħor ta 'infezzjoni jistgħu jkunu marbuta mal- marda
- respiratory problems, i. e., difficulty in breathing or coughing which may be linked to infections
- problemi respiratorji jiġifieri diffikultà biex tieħu n- nifs jew sogħla li tista 'tkun marbuta ma'
you have caught as a result of your disease;
infezzjonijiet li tkun ħadt minħabba l- marda tiegħek;
- if you have previously had skin reactions, i. e., pain, redness and dryness of skin, during
- jekk qabel kellek reazzjonijet tal- ġilda jiġifieri uġigħ, ħmura u ġilda xotta waqt it- trattament bir -
treatment with radiotherapy, this may also happen with Caelyx.
radjuterapija, dan jista 'jiġri wkoll b’ Caelyx.
Other side effects that may occur with a combination of Caelyx and bortezomib include:
Jista ’ jkun hemm effetti sekondarji oħrajn bil- kombinazzjoni ta ’ Caelyx u bortezomib li jinkludu:
- joint pain, decreased or abnormal sensation to stimulation, inflammation of the cornea, redness
- uġigħ fil- ġogi, sensazzjoni mnaqqsa jew anormali b’ stimulazzjoni, infjammazzjoni tal- korneja,
of the eye, redness of the scrotum.
ħmura ta ’ l- għajnejn, ħmura ta ’ l- iskrotu.
39 When Caelyx is used alone, some of these effects are less likely to occur, and some have not occurred at all.
Meta Caelyx jintuża waħdu, xi wħud minn dawn effetti għandhom anqas ċans li jseħħu, u xi wħud ma seħħew xejn.
Strategies to prevent and treat hand-foot syndrome:
Strateġiji biex tevita u tikkura s- sindrome ta ’ l- id- sieq:
Every day for 4-7 days beginning immediately after you have received Caelyx:
Kuljum għal 4- 7 ijiem tibda immedjatament malli tkun ħadt Caelyx:
- soak hands and/ or feet in basins of cold water when possible (e. g. while watching television,
- xarrab idejk u/ jew saqajk ġo friskatur b’ ilma kiesaħ kull meta tista '(eż waqt li tara t- televiżjoni,
reading, or listening to the radio);
taqra, jew tisma 'r- radju);
- keep hands and feet uncovered (no gloves, socks, etc.);
- żomm idejk u saqajk mikxufin (mingħajr ingwanti, peduni eċċ.);
- stay in cool places;
- oqgħod f’ postijiet friski;
- take cool baths during hot weather;
- meta tagħmel is- sħana ħu banjijiet kiesħa;
- avoid vigorous exercise that might cause trauma to the feet (e. g. jogging);
- evita l- eżerċizzji goffi li jistgħu jagħmlu ħsara fis- saqajn (eż. ġiri);
- avoid exposure of skin to very hot water (e. g. jacuzzis, saunas);
- evita li tesponi l- ġilda għal ilma sħun ħafna (eż. jakuzzi, sawna);
- avoid tight fitting footwear or high-heeled shoes.
- evita żraben issikkati jew bit- takkuna għolja.
Pyridoxine (Vitamin B6):
Pyridoxine (Vitamina B6):
- Vitamin B6 is available without prescription.
- Il- Vitamina B6 tinxtara mingħajr riċetta.
- Take 50-150 mg daily beginning at the first signs of redness or tingling.
- Ħu 50- 150 mg kulljum malli tibda tara l- ewwel sinjali ta 'ħmura jew tingiż.
HOW TO STORE CAELYX
KIF TAĦŻEN CAELYX
Store in a refrigerator (2°C – 8°C).
Aħżen fi friġġ (2 °C – 8 °C).
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
L- istabilità kimika u fiżika waqt l- użu ġiet ippruvata għal 24 siegħa f' temperatura ta 'bejn 2°C sa 8°C.
From a microbiological point of view, the product should be used immediately.
Mill- lat mikrobijoloġiku, il- prodott għandu jintuża minnufih.
If not used 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.
Jekk ma jintużax minnufih, il - kundizzjonijiet u ż- żmien tal- ħazna waqt l- użu, huma r- responsabbiltà ta 'min jużah u m' għandhomx ikunu iżjed minn 24 siegħa f' 2°C sa 8°C.
Partially used vials must be discarded.
Kunjetti wżati ftit għandhom jintremew.
Do not use Caelyx after the expiry date which is stated on the label and carton.
Tużax Caelyx wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kartuna.
Do not use Caelyx if you notice that it shows evidence of precipitation or any other particulate matter.
Tużax Caelyx jekk tintebaħ illi qed juri sinjali ta 'preċipitazzjoni jew xi frak ieħor.
These measures will help to protect the environment.
Dawn il- miżuri se jgħinu għall - protezzjoni ta ’ l- ambjent.
What Caelyx contains
X’ fih Caelyx
One ml of Caelyx contains 2 mg of
- Is- sustanza attiva hi doxorubicin hydrochloride. ml wieħed ta ’ Caelyx fih 2 mg ta ’ doxorubicin
doxorubicin hydrochloride in a pegylated liposomal formulation.
hydrochloride b' formulazzjoni liposomali pegilata.
- The other ingredients are α -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-ω -
Is- sustanzi l- oħra jinkludu: α - (2 - [1, 2- distearoyl - sn- glycero (3) phosphooxy] ethylcarbamoyl) - ϖ -
methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE), fully hydrogenated soy phosphatidylcholine (HSPC), cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.
methoxypoly (oxyethylen) - 40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, ilma għall- injezzjonijiet, hydrochloric acid u sodium hydroxide
Caelyx concentrate for solution for infusion: vials which provide 10 ml (20 mg) or 25 ml (50 mg).
Kunjetti li jipprovdu 10 ml (20 mg) jew 25 ml (50 mg).
What Caelyx looks like and contents of the pack
Id- Dehra ta Caelyx u l- kontenuti tal- pakkett
40 The solution for infusion is sterile, translucent and red.
Is- soluzzjoni għall- infużjoni hija sterili, jgħaddi d- dawl minnha u ħamra.
Caelyx is available in glass vials as a single pack or packs of ten vials.
Caelyx issibha f’ kunjetti tal - ħġieġ f’ pakkett ta ’ wieħed jew għaxar kunjetti.
SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.
SP Europe, Rue de Stalle 73, B- 1180 Bruxelles, Belġju.
Manufacturer:
Manifattur:
SP Labo N. V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
SP Labo N. V., Industriepark 30, B- 2220 Heist- op- den- Berg, Belġju.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
This leaflet was last approved on
Dan il- fuljett kien approvat l- aħħar f ’
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /
42 The following information is intended for medical or healthcare professionals only (see section 3):
43 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- mediċina jew fil- qasam tas- saħħa (ara sezzjoni 3):
Caution must be exercised in handling Caelyx solution.
Wieħed irid joqgħod attent hu u jimmaniġġja s- soluzzjoni ta ’ Caelyx.
If Caelyx comes into contact with skin or mucosa, wash immediately and thoroughly with soap and water.
Jekk Caelyx imiss il- ġilda jew il- mukoża, aħsel minnufih u sew bl- ilma u s- sapun.
Caelyx must be handled and disposed of in a manner consistent with that of other anticancer medicinal products.
Caelyx għandu jintuża u jintrema bl- istessmod kif isir bil- prodotti mediċinali kontra l- kanċer oħrajn.
Determine the dose of Caelyx to be administered (based upon the recommended dose and the patient's body surface area).
Stabilixxi d- doża ta 'Caelyx li għandha tingħata (bbażata fuq id- doża rakkomandata u l- erja tas - superfiċje tal- ġisem tal- pazjent).
Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Caelyx.
Għandha tintuża teknika asettika bl- iżjed mod strett peress illi f’ Caelyx m’ hemmx sustanzi preservattivi jew batterjostatiċi.
The appropriate dose of Caelyx must be diluted in 5% (50 mg/ ml) glucose solution for infusion prior to administration.
Id- doża xierqa ta 'Caelyx għanda tiġi dilwita f' 5% (50 mg/ ml) soluzzjoni tal- glucose għall- infużjoni qabel ma tingħata.
To minimize the risk of infusion reactions, the initial dose is administered at a rate no greater than 1 mg/ minute.
Biex jitnaqqas kemm jista 'jkun ir- riskju ta' reazzjonijiet għall- infużjoni, id- doża tal- bidu għandha tingħata b' rata ta 'mhux aktar minn 1 mg/ minuta.
If no infusion reaction is observed, subsequent Caelyx infusions may be administered over a 60-minute period.
Jekk ma tiġi nnutata ebda reazzjoni, l- infużjonijiet ta 'wara b’ Caelyx ikunu jistgħu jingħataw fuq medda ta' 60 minuta.
In the breast cancer trial program, modification of the infusion was permitted for those patients experiencing an infusion reaction as follows:
Fil- programm ta 'provi dwar kanċer tas- sider, tibdil ta' l- infużjoni kien permess għal dawk il- pazjenti li kellhom reazzjoni għall- infużjoni kif ġej:
5% of the total dose was infused slowly over the first 15 minutes.
5% tad- doża totali ġiet infuża bil- mod fl- ewwel 15- il minuta.
If tolerated without reaction, the infusion rate was doubled for the next 15 minutes.
Jekk tkun tollerata mingħajr reazzjoni, r- rata ta 'infużjoni tiġi rduppjata għall- 15 - il minuta li jmiss.
If tolerated, the infusion was completed over the next hour for a total infusion time of 90 minutes.
Jekk tkun tollerata, l- infużjoni titlesta fis- siegħa li jmiss b' ħin ta 'infużjoni totali ta' 90 minuta.
If the patient experiences early symptoms or signs of infusion reaction, immediately discontinue the infusion, give appropriate premedications (antihistamine and/ or short acting corticosteroid) and restart at a slower rate.
Jekk il- pazjent/ a ġġarrab sintomi bikrija jew sinjali ta 'reazzjoni għall- infużjoni, waqqaf l- infużjoni immedjatament, agħti il- premedikamenti xierqa (anti- istamini u/ jew kortikosterojd li jaħdem malajr) u erġa' ibda b' rata iżjed baxxa.
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.
L- użu ta 'xi dilwent ieħor minflok 5% (50 mg/ ml) soluzzjoni tal - glucose għall- infużjoni jew il - preżenza ta' sustanzi batterjostatiċi bħalma hu benzyl alcohol jista 'jwassal għall- preċipitazzjoni ta’ Caelyx.
It is recommended that the Caelyx infusion line be connected through the side port of an intravenous infusion of 5% (50 mg/ ml) glucose.
Huwa rrakkomandat li l- linja ta 'infużjoni ta ’ Caelyx titqabbad mill- port tal- ġenb ta' infużjoni tal - glucose għal ġol- vini 5% (50 mg/ ml).
Do not use with in-line filters.
Tużahx b’ filtri tal - pajp tad- dripp.
What is Cancidas?
X’ inhu Cancidas?
Cancidas is a powder that is made up into a solution for infusion (drip into a vein).
Cancidas huwa trab li jitħallat biex isir soluzzjoni għall- infużjoni (drip fil- vina).
It contains the active substance caspofungin.
Huwa fih is- sustanza attiva caspofungin.
What is Cancidas used for?
Għal xiex jintuża Cancidas?
Cancidas is an antifungal medicine.
Cancidas huwa mediċina antifungali.
It is used to treat adults, adolescents and children with: • invasive candidiasis (a type of fungal infection due to Candida); • invasive aspergillosis (another type of fungal infection due to Aspergillus) when the patient does not respond to or does not tolerate amphotericin B or itraconazole (other antifungal medicines); • suspected fungal infections (such as due to Candida or Aspergillus) when the patient is febrile (feverish) and neutropenic (lacking white blood cells).
Jintuża biex jittratta pazjenti adulti, adolexxenti u tfal bi: • kandidjażi invażiva (tip ta ’ infezzjoni fungali dovuta għal Candida); • asperġillożi invażiva (tip ieħor ta ’ infezzjoni fungali dovuta għal Aspergillus), meta l- pazjent ma jirrispondix għal jew ma jittollerax l- amfoteriċina B jew itraconazole (mediċini antifungali oħrajn); • suspett ta ’ infezzjonijiet fungali (bħal dawk dovuti għal Candida jew Aspergillus) meta l- pazjent ikollu d- deni u jkun newtropeniku (ikollu nuqqas ta ’ ċelloli tad- demm bojod).
This is known as ‘ empirical treatment’, which means that the treatment is started based on an observation of the patient before the doctor has a confirmation of the infection.
Dan huwa magħruf bħala ‘ trattament empiriku ’, li jfisser li t- trattament jinbeda abbażi ta ’ osservazzjoni ta ’ pazjent qabel ma t- tabib ikollu konferma dwar l- infezzjoni.
How is Cancidas used?
Kif jintuża Cancidas?
Cancidas treatment should be started by a doctor who has experience in the management of invasive fungal infections.
It- terapija b’ Cancidas għandu jinbeda minn tabib li jkollu esperjenza fit- trattament ta ’ infezzjonijiet fungali invażivi.
Cancidas must be made up into a solution before use, using a diluent that does not contain glucose.
Cancidas għandu jitħallat biex isir soluzzjoni qabel ma jintuża, permezz ta ’ dilwent li ma fihx il- glukożju.
It is given once a day by slow infusion lasting about one hour.
Jingħata darba kuljum permezz ta ’ infużjoni bil- mod li ddum għaddejja siegħa.
In adults, treatment starts with a 70 mg loading dose, followed by a daily 50 mg dose, or 70 mg if the patient weighs more than 80 kg.
Fl- adulti, it- trattament jinbeda b’ doża ta ’ tagħbija (loading) ta ’ 70 mg, segwit b’ doża ta ’ 50 mg kuljum, jew 70 mg jekk il - pazjent ikun jiżen iktar minn 80 kg.
A lower dose may be necessary in adults who have moderate problems with their liver.
Adulti bi problemi moderati fil- fwied jistgħu jeħtieġu doża inqas qawwija.
In patients between 12 months and 17 years of age, the dose depends on body surface area (calculated using the child ’ s height and weight).
F’ pazjenti ta ’ bejn sena u 17- il sena, id- doża tiddependi mis- superfiċje tal- ġisem (ikkalkulata mit- tul u l- piż tat- tifel/ tifla).
Cancidas should be used with caution in children below 12 months of age, because it has not been studied sufficiently in this age group.
Cancidas għandu jintuża b’ kawtela fit- tfal iżgħar minn sena, minħabba li għadu ġiex studjat kemm meħtieġ f’ dan il- grupp ta ’ età.
Treatment is continued for up to two weeks after the infection has been cured.
It- trattament jitkompla sa ġimagħtejn wara li tkun tfejqet l- infezzjoni.
How does Cancidas work?
Kif jaħdem Cancidas?
The active substance in Cancidas, caspofungin, belongs to a group of antifungal medicines known as ‘ echinocandins’.
Is- sustanza attiva f’ Cancidas, caspofungin, tappartjeni għal grupp ta ’ mediċini antifungali magħrufin bħala ‘ ekinokandini ’ (echinocandins).
Fungal cells treated with Cancidas have incomplete or defective cell walls, making them fragile and 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Taħdem billi tinterferixxi mal- produzzjoni ta ’ komponent tal - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. unable to grow.
Reproduction is authorised provided the source is acknowledged ħajt taċ- ċellola fungali ‘ glukan polisakkaride ’ (glucan polysaccharide), li hija meħtieġa biex il- fungu jkompli jgħix u jikber.
The list of fungi against which Cancidas is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Il- lista ta ’ fungi li Cancidas huwa attiv kontrihom tinstab fis- Sommarju tal- Karatteristiċi tal- Prodott (parti wkoll mill- EPAR).
How has Cancidas been studied?
Kif ġie studjat Cancidas?
Cancidas has been studied in five main studies.
Cancidas ġie studjat f’ ħames studji ewlenin.
Three studies looked at the effects of Cancidas in the treatment of invasive candidiasis or aspergillosis: one study involved 239 adults with invasive candidiasis, another involved 69 adults with invasive aspergillosis, and the third involved 49 patients aged between six months and 17 years with either candidiasis or aspergillosis.
Tliet studji eżaminaw l- effetti ta ’ Cancidas fit- trattament ta ’ kandidjażi jew asperġillożi invażivi: studju wieħed kien jinvolvi 239 adult b’ kandidjażi invażiva, it- tieni wieħed kien jinvolvi 69 adult b’ asperġillożi invażiva, u t- tielet studju kien jinvolvi 49 pazjent ta ’ età bejn sitt xhur u 17- il sena li kienu jbatu jew minn kandidjażi jew minn asperġillożi.
Cancidas was compared with amphotericin B given into a vein in the study of adults with invasive candidiasis.
Cancidas tqabbel mal- amfoteriċina B li ngħata fil- vina fl- istudju li twettaq fuq l- adulti b’ kandidjażi invażiva.
For the empirical treatment of neutropenic febrile patients, Cancidas has been compared with amphotericin B in two studies: one involving 1,111 adults and another involving 82 patients aged between two and 17 years.
Għat- trattament empiriku ta ’ pazjenti newtropeniċi li jkollhom id- deni, Cancidas tqabbel mal - amfoteriċina B f’ żewġ studji: wieħed li kien jinvolvi 1, 111- il adult u ieħor li kien jinvolvi 82 pazjent bejn sentejn u 17- il sena.
In all five studies, the main measure of effectiveness was the number of patients who responded to treatment.
Fil- ħames studji kollha, il- kejl ewlieni tal- effikaċja kien l- għadd ta ’ pazjenti li rrispondew għat - trattament.
This is based on the improvement of their symptoms, as well as other criteria, such as elimination of the fungus from samples taken from the patients.
Dan huwa bbażat fuq it- titjib tas- sintomi tagħhom, kif ukoll kriterji oħra, bħall - eliminazzjoni tal- fungu mill- kampjuni meħuda mill- pazjenti.
What benefit has Cancidas shown during the studies?
X’ benefiċċju wera Cancidas matul l- istudji?
In invasive candidiasis, 73% of the adults treated with Cancidas who could be assessed had a favourable response (80 out of 109), compared with 62% of the adults treated with amphotericin B (71 out of 115).
Fil- każ tal- kandidjażi invażiva, 73% tal- adulti ttrattati b’ Cancidas li setgħu jiġu eżaminati wrew rispons favorevoli (80 minn 109), meta mqabbla mat- 62% tal- adulti ttrattati b’ amfoteriċina B (71 minn 115).
In invasive aspergillosis, 41% of the adults had a favourable response at the end of the study (26 out of 63).
Fil- każ tal- asperġillożi invażiva, 41% tal- adulti wrew rispons favorevoli fi tmiem l- istudju (26 minn 63).
Of the adults who did not respond to other treatments, 36% responded to Cancidas (19 out of 53).
Mill- adulti li ma wrewx rispons għal trattamenti oħra, 36% rrispondew għal Cancidas (19 minn 53).
Of those who did not tolerate other treatments, 70% responded to Cancidas (7 out of 10).
Minn dawk li ma ttollerawx trattamenti oħra, 70% rrispondew għal Cancidas (7 minn 10).
Similar responses were seen in children and adolescents:
Risponsi simili dehru fi tfal u adolexxenti:
50% of those with invasive candidiasis (5 out of 10) and 81% of those with invasive aspergillosis (30 out of 37) responded to Cancidas.
50% minn dawk b’ kandidjożi invażiva (5 minn 10) u 81% minn dawk b’ asperġillożi invażiva (30 minn 37) irrispondew għal Cancidas.
In the empirical treatment of febrile neutropenic patients, Cancidas was as effective as amphotericin B.
Fit- trattament empiriku ta ’ pazjenti newtropeniċi li jkollhom id- deni, Cancidas kien effikaċi daqs l - amfoteriċina B.
In the adult study, 34% of both groups of adults had a favourable response.
Fl- istudju fuq l- adulti, 34% taż- żewġ gruppi ta ’ adulti wrew rispons favorevoli.
Similar results were seen in the study of children and adolescents.
Riżultati simili ġew osservati fl- istudju fit- tfal u l- adolexxenti.
What is the risk associated with Cancidas?
X’ inhu r- riskju assoċjat ma ’ Cancidas?
The most common side effect with Cancidas (seen in more than 1 patient in 10) is fever.
L- iktar effett sekondarju komuni b’ Cancidas (li deher f' iktar minn pazjent wieħed minn kull 10) hu d - deni.
For the full list of all side effects reported with Cancidas, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati bi Cancidas, ara l- Fuljett ta ’ Tagħrif.
Cancidas should not be used in people who may be hypersensitive (allergic) to caspofungin or any of the other ingredients.
Cancidas ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal caspofungin jew għal xi sustanzi oħra tiegħu.
Why has Cancidas been approved?
Għaliex Cancidas ġie approvat?
The Committee for Medicinal Products for Human Use (CHMP) decided that Cancidas’ s benefits are greater than its risks for the treatment of invasive candidiasis or aspergillosis, and empirical therapy for presumed fungal infections, in adult or paediatric patients.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Cancidas huma akbar mir- riskji tiegħu għat- trattament ta ’ kandidjażi jew asperġillożi invażivi, u t - terapija empirika għal infezzjonijiet fungali f’ pazjenti adulti jew pedjatriċi.
The Committee recommended that Cancidas be given marketing authorisation.
Il- Kumitat irrakkomanda li Cancidas jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Cancidas was originally authorised under ‘ Exceptional Circumstances’, because limited information was available at the time of approval.
Cancidas kien oriġinarjament awtorizzat taħt ‘ Ċirkostanzi ta ’ Eċċezzjoni ’, minħabba li kien hemm informazzjoni limitata meta saret l- approvazzjoni.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 29 September 2006.
Billi l- kumpanija kienet pprovdiet it- tagħrif addizzjonali mitlub, iċ - ‘ Ċirkustanzi ta 'Eċċezzjoni ’ intemmu fid- 29 ta' Settembru 2006.
Other information about Cancidas:
Tagħrif ieħor dwar Cancidas:
The European Commission granted a marketing authorisation valid throughout the European Union for Caspofungin MSD to Merck Sharpe and Dohme Limited on 24 October 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Caspofungin MSD lil Merck Sharpe u Dohme Limited fl- 24 ta ’ Ottubru 2001.
The name of the medicine was changed to Cancidas on 9 April 2003.
L- isem tal - mediċina nbidel f’ Cancidas fid- 9 ta ’ April 2003.
The marketing authorisation was renewed on 24 October 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 24 ta ’ Ottubru 2006.
The full EPAR for Cancidas is available here.
L- EPAR sħiħ għal Cancidas jista ’ jiġi kkonsultat hawn.
This summary was last updated in 11-2008.
Dan is- sommarju kien aġġornat l- aħħar fi: 11- 2008.
Strength
Daqs tal- pakkett
Pharmaceutical Form
Qawwa
Route of Administration
Għamla farmaċewtika
Packaging
Mnejn jingħata
Content
Il- pakkett
Package size
Kontenut
Powder for concentrate for solution for infusion
Trab għal konċentrat għal soluzzjoni għal infużjoni
Intravenous use
Użu għal- ġol vini
vial (glass)
kunjett (ħġieġ)
1 vial
1 kunjett
CANCIDAS 50 mg powder for concentrate for solution for infusion
CANCIDAS 50 mg trab għal konċentrat għal soluzzjoni għal infużjoni
Each vial contains 50 mg caspofungin (as acetate).
Kull kunjett fih 50 mg caspofungin (bħala aċetat).
Each 50mg vial contains 35.7 mg of sucrose.
Kull kunjett ta ’ 50 mg fih 35. 7 mg ta ’ sucrose.
Powder for concentrate for solution for infusion.
Trab għal konċentrat għal soluzzjoni għal infużjoni.
White to off-white compact, lyophilised powder.
Trab kumpatt abjad għal offwajt, lajofiliżżat.
• Treatment of invasive candidiasis in adult or paediatric patients. • Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/ or itraconazole.
• Trattament ta ’ kandidjasi invażiva f’ pazjenti adulti jew pedjatriċi. • Trattament ta ’ asperġillożi invażiva f’ pazjenti adulti jew pedjatriċi li huma refrattorji jew intolleranti għal amphotericin B, formulazzjonijiet lipidi ta ’ amphotericin B u/ jew itraconazole.
Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. • Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.
Ir- refrattorjetà hija definita bħala l- progressjoni tal- infezzjoni jew in- nuqqas ta ’ titjib wara minimu ta ’ 7 ijiem ta ’ dożi terapewtiċi preċedenti ta ’ terapija antifungali effettiva. • Terapija empirika għal infezzjonijiet fungali preżunti (bħal Candida jew Aspergillus) f’ pazjenti newtropeniċi febbri adulti jew pedjatriċi.
CANCIDAS should be initiated by a physician experienced in the management of invasive fungal infections.
CANCIDAS għandu jinbeda minn tabib li għandu esperjenza fil- ġestjoni ta ’ infezzjonijiet fungali invażivi.
After reconstitution and dilution, the solution should be administered by slow intravenous infusion over approximately 1 hour.
Wara rikostituzzjoni u dilwizzjoni, is- soluzzjoni għandha tingħata b’ infużjoni bil- mod fil- vini fuq perjodu ta ’ madwar siegħa.
Do not mix or co-infuse CANCIDAS with other medicines, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products.
CANCIDAS m’ għandux jiġi mħallat jew infuż ma ’ mediċini oħra, billi m’ hemmx informazzjoni disponibbli dwar il- kompatibilità ta ’ CANCIDAS ma ’ sustanzi, addittivi jew prodotti mediċinali oħra għal ġol- vini.
DO NOT USE DILUENTS CONTAINING GLUCOSE, as CANCIDAS is not stable in diluents containing glucose.
M’ GĦANDHOMX JINTUŻAW DILWENTI LI FIHOM IL - GLUKOŻJU, billi CANCIDAS mhuwiex stabbli f’ dilwenti li fihom il- glukożju.
For reconstitution directions see section 6.6.
Għal struzzjonijiet dwar ir- rikostituzzjoni, ara sezzjoni 6. 6.