qanastek/EMEA-V3 huggingface dataset:
Different groups of patients using Fabrazyme The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.
Gruppi differenti ta ’ pazjenti li jużaw Fabrazyme It- tagħrif f’ dan il- fuljett japplika għal gruppi kollha ta ’ pazjenti inkluż it- tfal, adoloxxenti, adulti u l- anzjani.
31 Using other medicines There are no known interactions with other medicinal products.
32 Meta tieħu mediċini oħra M’ hemm l- ebda interazzjonijiet magħrufa ma ’ prodotti mediċinali oħra.
Fabrazyme should not be administered with chloroquine, amiodarone, benoquin or gentamicin due to a theoretical risk of decreased agalsidase beta activity.
Fabrazyme m’ għandux jingħata flimkien ma ’ chloroquine, amiodarone, benoquin jew gentamicin minħabba riskju teoretiku ta ’ tnaqqis fl- attività ta ’ l- agalsidase beta.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew l- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Using Fabrazyme with food and drink Interactions with food and drink are unlikely.
Meta tieħu Fabrazyme ma ’ l- ikel u max- xorb Mhux probabbli li jkun hemm interazzjonijiet ma ’ l- ikel u x- xorb.
Pregnancy and breast-feeding Use of Fabrazyme during pregnancy is not recommended.
Tqala u Treddigħ Fabrazyme mhux rakkomandat li jingħata waqt it- tqala.
There is no experience with the use of Fabrazyme in pregnant women.
M’ hemmx esperjenza dwar l- użu ta ’ Fabrazyme fin- nisa tqal.
Fabrazyme may get into breast milk.
Fabrazyme għandu mnejn jidħol fil- ħalib tas- sider.
Use of Fabrazyme during breast- feeding is not recommended.
Mhux rakkomandat li Fabrazyme jingħata waqt it- treddigħ.
Ask your doctor or pharmacist for advice before taking this medicine.
Itlob il- parir tat- tabib jew l- ispiżjar tiegħek qabel tieħu xi mediċina.
HOW TO USE FABRAZYME
KIF GĦANDEK TUŻA FABRAZYME
Fabrazyme is given through a drip into a vein (by intravenous infusion).
Fabrazyme jingħata permezz ta ’ dripp ġol vina (b’ infużjoni ġol- vina).
It is supplied as a powder which will be mixed with sterile water before it is given (see information for Health Care Professionals)
Huwa jiġi bħala trab li jitħallat ma ’ l- ilma sterili qabel ma ’ jingħata (ara tagħrif għal Professjonisti tal- Kura tas- Saħħa)
Fabrazyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Fabry disease.
Fabrazyme jingħata biss taħt is- superviżjoni ta ’ tabib li hu infurmat tajjeb dwar it- trattament tal- marda Fabry.
The recommended dose of Fabrazyme for adults and children 8 – 16 years is 1 mg/ kg body weight, once every 2 weeks.
Id- doża rrakkomandata ta ’ Fabrazyme għal adulti u tfal ta ’ bejn 8 - 16- il sena hi 1 mg/ kg piż tal- ġisem darba kull ħmistax.
No changes in dose are necessary for patients with kidney disease.
M’ hemm bżonn l- ebda tibdil fid- doża għall- pazjenti li għandhom il- mard tal- kliewi.
If you use more Fabrazyme than you should There are no cases of overdose of Fabrazyme reported.
Jekk tuża Fabrazyme aktar milli suppost Ma ġew rapportati l- ebda każi ta ’ doża eċċessiva b’ Fabrazyme.
Doses up to 3 mg/ kg body weight have shown to be safe.
Dożi sa 3 mg/ kg piż tal- ġisem urew li huma sikuri.
If you forget to use Fabrazyme If you have missed an infusion of Fabrazyme, please contact your doctor.
Jekk tinsa tieħu Fabrazyme Jekk ma ħadtx xi infużjoni ta ’ Fabrazyme, jekk jogħġbok ikkuntattja lit- tabib tiegħek.
Like all medicines, Fabrazyme can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Fabrazyme jista ’ jkollu effetti oħra, għalkemm ma jidhrux fuq kulħadd.
In clinical studies side effects were mainly seen while patients were being given the medicine or shortly after.
Fi studji kliniċi l- effetti sekondarji li dehru waqt li l- pazjenti kienu qed jingħataw il- mediċina jew ftit wara.
If you experience any serious side effect or side effects not listed, please tell your doctor immediately.
Jekk ikollok xi effett kollaterali serju jew ikollok xi effett sekondarji li mhux elenkat, jekk jogħġbok għid lit- tabib tiegħek minnufih.
32 In clinical trials the following side effects were reported:
33 Fil- provi kliniċi ġew irrapportati l- effetti sekondarji li ġejjin:
Very common (occurring in more than 1 in 10 patients): • chills
Komuni ħafna (li jseħħu f’ aktar minn pazjent 1minn kull 10): • sirdat
abnormal touch feeling (pins and needles)
is- sens tal- ħass hu anormali • tħoss il- bard (tinġiż qisu labar)
• feeling cold
• deni • uġigħ ta ’ ras
nausea vomiting
dardir rimettar
Common (occurring in 1 in 100 to 1 in 10 patients): • chest pain
Komuni (li jseħħu f’ pazjent 1 minn kull 100 sa 1 minn kull 10): • •
• sleepiness
uġigħ fis- sider
• chest pain • sleepiness •
• ngħas • żieda fit- taħbit tal- qalb
• increased heart beat
• għeja • fwawar
• pallor • back pain •
diffikultà biex tieħu nifs
throat tightness
• uġigħ addominali
• itching
• uġigħ
• rash
• • •
• itching • rash •
sfurija ħakk jifforma dmugħ abnormali
• abnormal tear
• uġigħ fid- dahar • raxx • taħbit tal- qalb baxx
• abnormal tear • low heart rate •
• tagħfis fil- griżmejn • sturdament • palpitazzjonijiet
palpitations
• • • • • •
secretion • feeling weak
tħossok debboli tinnite konġestjoni nażali dijarea ħmura uġigħ muskolari
• feeling weak • lethargy •
• letarġija • sinkope • sogħla • skumdita addominali • nefħa fil- wiċċ • uġigħ fil- ġogi
decreased sensitivity to pain
• tnaqqis fis- sensittività għall- uġigħ • sensazzjoni ta ’ ħruq • tħarħir • urtikarja • uġigħ fl- estremitajiet • nasofarinġite
• tinnitus • syncope •
• żieda fil- prssjoni tad - • pressjoni tad- demm baxxa • fawra sħuna demm •
burning sensation
Nefħa f’ daqqa tal - wiċċ jew il- griżmejn
• nasal congestion
• skumdita fis- sider
• cough
• tħoss is- sħana
• diarrhoea
edema fl- estremitajiet • tħoss kollox idur bik
• abdominal discomfort
edema tal- wiċċ • diffikultajiet kbar biex tieħu n- nifs
• diarrhoea • abdominal discomfort •
• ipertermja • tnaqqis fis- sensittività tal- ħalq
pain at the extremities
skumdita fl- istonku spażmi muskolari
• muscle pain
• ebusija tal- muskoli
• joint pain
• ebusija muskolskeletrika
• muscle pain • joint pain •
Mhux komuni (li jseħħu f’ pazjent 1 minn kull 1000 sa 1 minn kull 100): •
nasopharyngitis
rogħda
• increased blood
• ħakk fl- għajnejn
sudden swelling of the • chest discomfort face or throat
qalb tħabbat bil- mod minħabba disturbi ta ’ trasmissjoni
oedema in extremities • face oedema vertigo • exacerbated difficulty in breathing
għajnejn ħomor uġigħ fil- widnejn uġigħ fil- griżmejn nifsijiet mgħaġġla
• hyperthermia • decreased mouth sensitivity
• widna minfuħa • bronkospażmu • mnieħer iqattar • ħruq ta ’ stonku
stomach discomfort • muscle tightness muscle spasms
sensittività ogħla għall- uġigħ konġestjoni fl- apparat respiratorju ta ’ fuq raxx ħamrani
• musculoskeletal stiffness
• •
Uncommon (occurring in 1 in 1000 to 1 in 100 patients): • tremor
raxx bil- ħakk Tħoss is- sħana u l- bard
• itching eyes • low heart rate due t
• skumdita fil- ġilda • uġigħ muskolu - skeletriku
• tremor • itching eyes •
• •
low h eart rate due to conduction disturbances
telf tal- kulur tal- ġilda (dbabar vjola) kesħa fl- estremitajiet
• ear swelling • incr
diffiċli tibla ’ uġigħ fis- sit ta ’ l- infużjoni
increased sensitivity to pain
• rinite • mard bħal ta ’ l- influwenza
upper respiratory tract congestion
emboli tad- demm fis- sit ta ’ l- injezzjoni telf tal- kulur tal- ġilda
• runny nose
reazzjoni fis- sit ta ’ l- infużjoni
• throat pain • runny nose •
• tħossok ma tiflaħx
• heart burn
edema
Unknown frequency •
Frekwenza mhix magħrufa •
Serious allergic reactions
reazzjonijiet allerġiċi serji
serious inflammation of the vessels
infjammazzjoni serja tal- vażi tad- demm (vini/ arterji)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
34 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE FABRAZYME
KIF TAĦŻEN FABRAZYME
Unopened vials Store in a refrigerator (2 °C – 8 °C).
Kunjetti mhux miftuħa Aħżen fi friġġ (2°C – 8°C).
Do not use Fabrazyme after the expiry date which is stated on the labelling after the letters ‘EXP’.
Tużax Fabrazyme wara d- data li jiskadi li tidher fuq it- tikketta wara ‘ JIS ’.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill- ispiżjar dwar kif għandek tarmi mediċini li m’ għankekx bżonn.
What Fabrazyme contains
X’ fih Fabrazyme
- The active substance is agalsidase beta, one vial contains 35 mg.
- Is- sustanza attiva hi agalsidase beta, kunjett wieħed fih 35 mg.
- Other ingredients are:
- Sustanzi oħra jinkludu:
What Fabrazyme looks like and contents of the pack Fabrazyme is supplied as a white to off-white, powder.
Id- dehra tal- prodott u d- daqs tal- pakkett Fabrazyme jiġi bħala trab ta ’ lewn bajdani jew off- white.
After reconstitution it is a clear, colourless liquid, free from foreign matter.
Wara r- rikostituzzjoni huwa likwidu ċar mingħajr kulur, ħieles minn kull materja barranija.
The reconstituted solution must be further diluted.
Is- soluzzjoni rikostitwita trid tiġi dilwita aktar.
Package sizes:
Id- daqsijiet tal- pakketti huma:
1, 5 and 10 vials per carton.
1, 5 u 10 kunjetti.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux id- daqsijiet kollha jitpoġġew fis- suq.
Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
Marketing authorisation holder Genzyme Europe B.V., Gooimeer 10, NL-1411DD Naarden, The Netherlands.
Id- detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq Genzyme Europe B. V., Gooimeer 10, NL- 1411 DD Naarden, l- Olanda.
Manufacturer Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom.
Manifattur Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, ir- Renju Unit.
34 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
35 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
There are also links to other websites about rare diseases and treatments.
Hemm ukoll links għall- websites oħra dwar mard rari 2H
35 The following information is intended for medical or healthcare professionals only:
36 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- mediċina jew fil- qasam tas- saħħa
Instructions for use – reconstitution, dilution and administration
Struzzjonijiet dwar l- użu – rikostituzzjoni, dilwazzjoni u kif jingħata
From a microbiological point of view, the product should be used immediately.
Mil- lat mikrobijoloġiku, il- prodott għandu jintuża mill- ewwel.
If not used immediately, in-use storage and conditions are the responsibility of the user.
Jekk ma jintużax mill- ewwel, il- ħażna waqt l- użu u l- kondizzjonijiet ta ’ qabel l- użu huma r- responsabbiltà ta ’ min jużah.
The reconstituted solution cannot be stored and should be promptly diluted; only the diluted solution can be held for up to 24 hours at 2ºC -8º C.
Is- soluzzjoni rikostitwita ma tistax tinħażen u għandha tiġi dilwita minnufih; Is- soluzzjoni dilwita biss tista ’ tinżamm sa 24 siegħa f’ temperatura ta ’ bejn u 2 °C - 8 °C.
Determine the number of vials to be reconstituted based on the individual patient's weight and remove the required vials from the refrigerator in order to allow them to reach room temperature (in approximately 30 minutes).
Ikkalkula l- għadd ta ’ kunjetti li jridu jiġu rrikostitwiti skond il- piż tal- ġisem individwali tal- pazjent u neħħi l- kunjetti meħtieġa minn ġol- friġġ biex tħallihom jilħqu t- temperatura tal- kamra (f’ madwar 30 minuta).
Each vial of Fabrazyme is intended for single use only.
Kull kunjett ta ’ Fabrazyme huwa maħsub biex jintuża darba biss.
Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Irrikostitwixxi kull kunjett ta ’ Fabrazyme 35 mg b’ 7. 2 ml ta ’ ilma għall- injezzjonijiet.
Avoid forceful impact of the water for injections on the powder and avoid foaming.
Evita l- impatt qawwi ta ’ l- ilma għall- injezzjonijiet fuq it- trab u evita r- ragħwa fis- soluzzjoni.
This is done by slow drop- wise addition of the water for injection down the inside of the vial and not directly onto the lyophilized cake.
Dan isir b’ addizzjoni qatra qatra ta ’ l- ilma għall- injezzjoni mal- ġenb ġewwieni tal- kunjett u mhux direttament fuq il- kejk lajofilizzat.
Prior to adding the reconstituted volume of Fabrazyme required for the patient dose, it is recommended to remove an equal volume of 0.9% sodium chloride intravenous solution, from the infusion bag.
Qabel maż- żid il- volum rikostitwit ta ’ Fabryzyme għad- doża tal- pazjent, huwa rakkomandat li tneħħi volum ugwali ta ’ soluzzjoni għal ġol vina ta ’ 0. 9% sodium chloride, minn ġol- borża ta ’ l- infużjoni.
Remove the airspace within the infusion bag to minimize the air/liquid interface.
Neħħi l- ispazju ta ’ l- arja minn ġol- borża ta ’ l- infużjoni biex timminimizza l- wiċċ bejn l- arja u l- likwidu.
Slowly, withdraw 7.0 ml (equal to 35 mg) of the reconstituted solution from each vial up to the total volume required for the patient dose.
Bil- mod neħħi 7. 0 ml (ugwali għal 35 mg) ta ’ soluzzjoni rikostitwita minn kull kunjett sakemm iġġib il- volum meħtieġ biex tagħmel id- doża tal- pazjent.
Do not use filter needles and avoid foaming.
Tużax labar bil- filters u tevita r- ragħwa.
Then slowly inject the reconstituted solution directly into the 0.9% sodium chloride intravenous solution (not in any remaining airspace) to a final concentration between 0.05 mg/ml and 0.7 mg/ml.
Imbagħad injetta bil- mod is- soluzzjoni rikostitwita fis- soluzzjoni intravenuża ta ’ 0. 9% sodium chloride (mhux f’ xi wiċċ li fadal ta ’ arja) għal konċentrazzjoni finali ta ’ bejn 0. 05 mg/ ml u 0. 7 mg/ ml.
Determine the total volume of sodium chloride 0.9% solution for infusion (between 50 and 500 ml) based on the individual dose.
37 sodium chloride (bejn 50 u 500 ml) skond id- doża individwali.
Do not shake or excessively agitate the infusion bag.
M’ għandekx tħawwad jew taġita b’ mod qawwi l- borża ta ’ l- infużjoni.
36 Administration
Kif jingħata
The initial infusion rate should be no more than 0.25 mg/min (15 mg/hour) to minimise the potential occurrence of infusion -associated reactions.
Ir- rata inizjali ta ’ l- infużjoni m’ għandix tkun iżjed minn 0. 25 mg/ min (15 mg/ siegħa) biex tnaqqas ir- riskju ta ’ xi reazzjonijiet relatati ma ’ l- infużjoni.
INFORMATION FOR THE USER
38 FULJETT TA ’ TAGĦRIF:
Fabrazyme 5 mg powder for concentrate for solution for infusion Agalsidase beta
Fabrazyme 5 mg trab għal konċentrat għal soluzzjoni għall- infużjoni Agalsidase beta
Before you use Fabrazyme 3.
Qabel ma tużaFabrazyme 3.
WHAT FABRAZYME IS AND WHAT IT IS USED FOR
X’ INHU FABRAZYME U GĦA XIEX JINTUŻA
Fabrazyme is used as enzyme replacement therapy in Fabry disease, where the level of α- galactosidase enzyme activity is absent or lower than normal.
Fabrazyme jingħata bħala terapija ta ’ sostituzzjoni ta ’ enżimi fil- marda Fabry, meta l- livell ta ’ l- attività enżimatika ta ’ α- galactosidase hija nieqsa jew inqas min- normal.
Do not use Fabrazyme If you have experienced an allergic anaphylactic reaction to agalsidase beta or if you are allergic (hypersensitive) to any of the other ingredients of Fabrazyme.
Tużax Fabrazyme Jekk int kellek reazzjoni allerġika anafilattika għall- agalsidase beta jew jekk int tbati minn sensittività eċċessiva għal kwalunkwe sustanzi oħra ta ’ Fabrazyme.
An infusion- associated reaction is any side effect occurring during the infusion or until the end of the infusion day (See 4 “Possible Side Effects”).
Reazzjoni assoċjata ma ’ l- infużjoni hija kull effett sekondarju li jista ’ jiżviluppa waqt l- infużjoni jew sa tmiem il- ġurnata ta ’ l- infużjoni (Ara 4 “ Effetti Sekondarji li Jista ’ Jkollu ”).
38 Using other medicines There are no known interactions with other medicinal products.
39 Meta tieħu mediċini oħra M’ hemm l- ebda interazzjonijiet magħrufa ma ’ prodotti mediċinali oħra.
The recommended dose of Fabrazyme for adults and children 8 – 16 years is 1 mg/kg body weight, once every 2 weeks.
Id- doża rrakkomandata ta ’ Fabrazyme għal adulti u tfal ta ’ bejn 8 - 16- il sena hi 1 mg/ kg piż tal- ġisem, darba kull ħmistax.
No changes in dose are necessary for patients with kidney disease.
M’ hemm bżonn l- ebda tibdil fid- doża għall- pazjenti li għandhom mard tal- kliewi.
Doses up to 3 mg/kg body weight have shown to be safe.
Dożi sa 3 mg/ kg piż tal- ġisem urew li huma sikuri
If you forget to use Fabrazyme If you have missed an infusion of Fabrazyme, please contact your doctor.
Jekk tinsa tieħu Fabrazyme Jekk inqast li tieħu infużjoni ta ’ Fabrazyme, jekk jogħġbok ikkuntattja lit- tabib tiegħek.
Like all medicines, Fabrazyme can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Fabrazyme jista ’ jkollu effetti oħra, għalkemm ma jidhrux fuq kulħadd
39 In clinical trials the following side effects were reported:
40 Fil- provi kliniċi ġew irrapportati l- effetti sekondarji li ġejjin:
Very common (occurring in more than 1 in 10 patients): • chills
Komuni ħafna (li jseħħu f’ aktar minn pazjent 1 minn kull 10): • sirdat
• hyperthermia • decreased mouth sensitivity
• widna minfuħa • bronkospażmu • mnieħer iqattar • ħruq ta ’ l- istonku
Uncommon (occurring in 1 in 1000 to 1 in 100 patients): • tremor
raxx bil- ħakk tħoss is- sħana jew il - bard
low heart rate due to conduction disturbances
telf tal- kulur tal- ġilda (dbabar vjola) kesħa fl- estremitajiet
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
41 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek...
Unopened vials Store in a refrigerator (2 °C – 8 °C).
Kunjetti mhux miftuħa Aħżen fi friġġ (2 °C – 8 °C).
Medicines should not be disposed of via wastewater or household waste.
Tużax Fabrazyme wara d- data li jiskadi li tidher fuq it- tikketta wara JIS.
- The active substance is agalsidase beta, one vial contains 5 mg.
- Is- sustanza attiva hi agalsidase beta, kunjett wieħed fih 5 mg.
What Fabrazyme looks like and contents of the pack Fabrazyme is supplied as a white to off-white powder.
Id- dehra tal- prodott u d- daqs tal- pakkett Fabrazyme jiġi bħala trab, ta ’ lewn bajdani jew off- white.
41 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
42 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
There are also links to other websites about rare diseases and treatments.
Hemm ukoll links għall- websites oħra dwar mard rari 3H
42 The following information is intended for medical or healthcare professionals only:
43 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- mediċina jew fil- qasam tas- saħħa
Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Irrikostitwixxi kull kunjett ta ’ Fabrazyme 5 mg b’ 1. 1 ml ta ’ ilma għall- injezzjonijiet.
Prior to adding the reconstituted volume of Fabrazyme required for the patient dose, it is recommended to remove an equal volume of 0.9% sodium chloride intravenous solution, from the infusion bag.
Qabel maż- żid il- volum rikostitwit ta ’ Fabryzyme għad- doża tal- pazjent, huwa rakkomandat li tneħħi volum ugwali ta ’ soluzzjoni għal ġol- vina ta ’ 0. 9% sodium chloride, minn ġol- borża ta ’ l- infużjoni.
Determine the total volume of sodium chloride 0.9% solution for infusion (between 50 and 500 ml) based on the individual dose.
44 sodium chloride (bejn 50 u 500 ml) skond id- doża individwali.
43 Administration
Kif jingħata
The initial infusion rate should be no more than 0.25 mg/min (15 mg/hour) to minimise the potential occurrence of infusion-associated reactions.
Ir- rata inizjali ta ’ l- infużjoni m’ għandix tkun iżjed minn 0. 25 mg/ min (15 mg/ siegħa) biex tnaqqas ir- riskju ta ’ xi reazzjonijiet relatati ma ’ l- infużjoni.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat dwar Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) evalwa l- istudji li saru, biex wasal għar- rakkomandazzjonijiet tiegħu dwar l- użu ta ’ din il- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew dwar il- kura tiegħek, aqra l- Fuljett ta ’ Tagħrif (ukoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni fuq il- bażi tar- rakkomandazzjonijiet tal- CHMP, aqra d- diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Fareston?
X’ inhu Fareston?
Fareston is a medicine that contains the active substance toremifene.
Fareston huwa mediċina li fiha s- sustanza attiva toremifene.
It is available as white, round tablets (60 mg).
Huwa disponibbli bħala pilloli bojod, tondi (60 mg).
What is Fareston used for?
Għalxiex jintuża Fareston?
Fareston is used to treat hormone-dependent metastatic breast cancer in women who have been through the menopause. ‘ Metastatic ’ means that the cancer has spread to other parts of the body.
Fareston jintuża għat- trattament ta ’ kanċer tas- sider metastatiku dipendenti fuq l- ormoni f’ nisa li jkunu qabżu l- menopawsa. ‘ Metastatiku ’ jfisser li l- kanċer ikun infirex għal partijiet oħra tal- ġisem.
Fareston is not recommended for patients with oestrogen-receptor-negative tumours (where the cancer cells do not have receptors for the hormone oestrogen on their surface).
Fareston mhux rakkomandat għal pazjenti b’ tumuri negattivi għar- riċetturi tal- estroġenu (fejn iċ- ċelloli tal - kanċer ma jkollhomx riċetturi għall- ormon tal- estroġenu fuq il- wiċċ tagħhom).
The medicine can only be obtained with a prescription.
Din il- mediċina tista ’ tinkiseb biss b’ riċetta tat- tabib.
How is Fareston used?
Kif jintuża Fareston?
The recommended dose of Fareston is one tablet once a day.
Id- doża rakkomandata ta ’ Fareston hija pillola waħda kuljum.
It should be used with caution in patients who have problems with their liver.
Huwa għandu jintuża b’ kawtela f’ pazjenti li għandhom problemi bil- fwied tagħhom.
How does Fareston work?
Kif jaħdem Fareston?
Most types of breast cancer grow in response to the hormone oestrogen.
Ħafna tipi ta ’ kanċer tas- sider jikbru b’ rispons għall- ormon tal- estroġenu.
The active substance in Fareston, toremifene, is an anti-oestrogen.
Is- sustanza attiva f’ Fareston, toremifene, hija antiestroġenu.
It attaches to the receptors for oestrogen on the surface of cells, where its main effect is to block the effects of the hormone.
Hija taqbad mar- riċetturi tal- estroġenu fuq il- wiċċ taċ- ċelloli, fejn l - effett prinċipali tagħha huwa li timblokka l- effetti tal- ormon.
As a result, the tumour cells are not stimulated to grow by oestrogen and the growth of the tumour is reduced.
B’ riżultat ta ’ dan, iċ- ċelloli ta ’ tumur ma jiġux stimulati biex jikbru mill- estroġenu u t- tkabbir tat- tumur jiġi mnaqqas.
How has Fareston been studied?
Kif ġie studjat Fareston?
The effects of Fareston were first tested in experimental models before being studied in humans.
L- effetti ta ’ Fareston ġew ittestjati l- ewwel darba f’ mudelli sperimentali qabel ma ġew studjati fil - bniedem.
Fareston has been studied in 1,869 postmenopausal women with metastatic breast cancer in four main studies.
Fareston ġie studjat f’ 1, 869 mara b’ kanċer tas- sider wara l- menopawsa f’ erba ’ studji prinċipali.
The effects of Fareston were compared with those of tamoxifen (another anti-oestrogen used to treat breast cancer).
L - effetti ta ’ Fareston ġew imqabbla ma ’ dawk ta ’ tamoxifen (anti- estroġenu ieħor użat għat- trattament tal- kanċer tas- sider).
The main measures of effectiveness were response rate (the number of patients whose tumours responded to treatment), time to progression (the length of time until the disease got worse) and survival.
Il- kejl prinċipali tal- effikaċja kienu r- rata ta ’ rispons (in- numru ta ’ pazjenti li t - tumuri tagħhom irrispondew għat- trattament), iż- żmien għall- progressjoni (it- tul taż- żmien sakemm il - marda marret għall- agħar) u s- sopravivenza.
What benefit has Fareston shown during the studies?
X’ benefiċċju wera Fareston waqt l- istudji?
The effectiveness of Fareston and tamoxifen were equivalent.
L- effikaċja ta ’ Fareston u tamoxifen kienu ekwivalenti.
Reproduction is authorised provided the source is acknowledged. progression and survival rates as the patients taking tamoxifen.
Reproduction is authorised provided the source is acknowledged. għall- progressjoni u rati ta ’ sopravivenza simili għal dawk ta ’ pazjenti li jieħdu tamoxifen.
This was confirmed in the fourth study.
Dan kien ikkonfermat fir- raba ’ studju.
What is the risk associated with Fareston?
X’ inhu r- riskju assoċjat ma ’ Fareston?
The most common side effects with Fareston (seen in more than 1 patient in 10) are hot flushes and sweating.
L- aktar effetti sekondarji komuni b’ Fareston (dehru f’ aktar minn 1 minn kull 10 pazjenti) huma fwawar u perspirazzjoni.
For the full list of all side effects reported with Fareston, see the Package Leaflet.
Għal- lista kompleta tal- effetti sekondarji kollha rrappurtati b’ Fareston, ara l - Fuljett ta ’ Tagħrif.
Fareston should not be used in people who may be hypersensitive (allergic) to toremifene or any of the other ingredients.
Fareston m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal toremifene jew għal xi waħda mis- sustanzi l- oħra.
It must not be used on a long-term basis in patients who have endometrial hyperplasia (thickening of the lining of the womb) or severe liver problems.
Fareston m’ għandux jintuża fit- tul f’ pazjenti li jkollhom iperplasija ta ’ endometriju (taħxin tal- kisja tal- ġuf) jew problemi serji tal- fwied.
Fareston must not be used in patients with ‘ QT prolongation’ (a disruption of the electrical activity of the heart), electrolyte disturbances (altered levels of salts in the blood) especially hypokalaemia (low potassium levels), bradycardia (a very slow heart rate), heart failure (an inability of the heart to pump enough blood to the rest of the body) or a history of symptomatic arrhythmias (abnormal heart rhythms), or in patients also taking other medicines that can cause QT prolongation.
Fareston ma għandux jintuża f’ pazjenti li jbatu minn ‘ prologament QT ’ (sfaxxar tal- attività elettrika tal- qalb), disturbi tal- elekrolite (bdil fil- livelli tal- melħ fid- demm) speċjalment ipokalemija (livelli baxxi tal- potassju), bradikardija (rata baxxa ħafna tat- taħbit tal- qalb), kollass tal- qalb (nuqqas ta ’ kapaċità tal- qalb li tippompja demm biżżejjed għal bqija tal- ġisem) jew storja ta ’ arritmiji sintomatiċi (ritmi tal- qalb mhux normali), jew f’ pazjenti li jieħdu mediċini oħrajn li jikkawwżaw ukoll il- prolongament QT.
A list of these medicines is given in the Package Leaflet.
Il- lista sħiħa ta 'dawn il - mediċini tinsab fil- Fuljett ta' Tagħrif.
Why has Fareston been approved?
Għaliex ġie approvat Fareston?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits and risks of Fareston were comparable to those of tamoxifen in women with oestrogen-receptor-positive tumours.
Il- Kumitat dwar Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) ikkonkluda li l- benefiċċji u r - riskji ta ’ Fareston kienu komparabbli ma ’ dawk ta ’ tamoxifen f’ nisa li kellhom tumuri pożittivi għar - riċetturi tal- estroġenu.
Therefore, the Committee decided that Fareston’ s benefits are greater than its risks for the first line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.
Għalhekk, il- Kumitat iddeċieda li l- benefiċċji ta ’ Fareston huma akbar mir - riskji tiegħu għat- trattament ormonali inizjali ta ’ kanċer tas- sider metastatiku dipendenti fuq l- ormoni f’ nisa li qabżu l- menopawsa.
The Committee recommended that Fareston be given marketing authorisation.
Il- Kumitat irrakkomanda li Fareston jingħata l- awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Fareston:
Tagħrif ieħor dwar Fareston:
The European Commission granted a marketing authorisation valid throughout the European Union for Fareston on 14 February 1996.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Fareston fl- 14 ta ’ Frar 1996.
The marketing authorisation was renewed on 14 February 2001 and on 14 February 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 14 ta ’ Frar 2001 u fl- 14 ta ’ Frar 2006.
The marketing authorisation holder is Orion Corporation.
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq hija Orion Corporation.
The full EPAR for Fareston can be found here.
L- EPAR sħiħ għal Fareston jista ’ jinstab hawn.
This summary was last updated in 03-2009.
Dan is- sommarju kien aġġornat l- aħħar f’ 03- 2009.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ara parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Faslodex?
X’ inhu Faslodex?
Faslodex is a solution for injection that contains the active substance fulvestrant.
Faslodex huwa soluzzjoni għal injezzjoni li fiha s- sustanza attiva fulvestrant.
It is available in prefilled syringes (250 mg).
Huwa jiġi f’ siringi mimlija minn qabel (250 mg).
What is Faslodex used for?
Għalxiex jintuża Faslodex?
Faslodex is used for the treatment of locally advanced or metastatic breast cancer in postmenopausal women (women who have been through the menopause).
Faslodex jintuża għat- trattament ta ’ kanċer tas- sider avvanzat lokalment jew metastatiku f’ nisa li jkunu għaddew mill- menopawsa.
It is used when the cancer is ‘ oestrogen receptor positive ’ (where the cancer cells have receptors for the hormone oestrogen on their surface). ‘ Metastatic’ means that the cancer has spread to other parts of the body.
Huwa jintuża meta l- kanċer ikun ‘ pożittiv għar- riċetturi tal - estroġenu ’ (meta ċ- ċelloli tal- kanċer ikollhom riċetturi għall- ormon tal- estroġenu fuq il- wiċċ tagħhom). ‘ Metastatiku ’ jfisser li l- kanċer ikun infirex għal partijiet oħra tal- ġisem.
Faslodex is used when the disease has returned during or after treatment with an ‘ anti-oestrogen’ (a type of medicine used to treat breast cancer), or when the disease has got worse during treatment with an anti-oestrogen.
Faslodex jintuża meta l- marda terġa ’ titfaċċa waqt jew wara trattament b ’ ‘ anti- estroġenu ’ (tip ta ’ mediċina użata għat - trattament ta ’ kanċer tas- sider), jew meta l- marda tkun marret għall- agħar waqt trattament b’ anti - estroġenu.
The medicine can only be obtained with a prescription.
Din il- mediċina tista ’ tinkiseb biss b’ riċetta ta ’ tabib.
How is Faslodex used?
Kif jintuża Faslodex?
The recommended dose of Faslodex is 250 mg once a month, given by slow injection into the buttock muscle.
Id- doża rakkomandata ta ’ Faslodex hija 250 mg darba fix- xahar, mogħtija b’ injezzjoni bil- mod fil - muskolu tal- warrani.
Faslodex should be used with caution in patients who have problems with their liver or severe problems with their kidneys.
Faslodex għandu jintuża b’ kawtela f’ pazjenti li għandhom problemi bil- fwied jew problemi serji bil- kliewi tagħhom.
It should not be used in patients who have severe liver problems.
Huwa m’ għandux jintuża f’ pazjenti li għandhom problemi serji tal- fwied.
How does Faslodex work?
Kif jaħdem Faslodex?
Most types of breast cancer grow in response to the hormone oestrogen.
Ħafna tipi ta ’ kanċer tas- sider jiżviluppaw b’ rispons għall- ormon tal- estroġenu.
The active substance in Faslodex, fulvestrant, is an anti-oestrogen.
Is- sustanza attiva f’ Faslodex, fulvestrant, hija antiestroġenu.
It attaches to the receptors for oestrogen on the surface of cells, where it blocks the effects of the hormone and causes the number of oestrogen receptors to fall.
Hija taqbad mar- riċetturi tal- estroġenu fuq il- wiċċ taċ - ċelloli, fejn timblokka l- effetti tal- ormon u twassal għal tnaqqis tan- numru tar- riċetturi tal- estroġenu.
As a result, the tumour cells are not stimulated to grow by oestrogen and the growth of the tumour is reduced.
B’ riżultat ta ’ dan, iċ- ċelloli tat- tumur ma jiġux stimulati biex jikbru mill- estroġenu u t- tkabbir tat - tumur jitnaqqas.
Faslodex is absorbed slowly into the body, with the effects of each injection lasting over a month.
Faslodex jiġi assorbit bil- mod fil- ġisem, bl- effetti ta ’ kull injezzjoni jdumu fuq xahar.
The levels of the medicine in the body increase with subsequent injections, reaching a steady level after around six injections.
Il- livelli tal - mediċina fil- ġisem jiżdiedu ma ’ injezzjonijiet suċċessivi, u jilħqu livell stabbli wara madwar sitt injezzjonijiet.
How has Faslodex been studied?
Kif ġie studjat Faslodex?
 European Medicines Agency, 2009.
European Medicines Agency, 2009 Reproduction authorised provided the source is acknowledged L- effetti ta ’ Faslodex ġew ittestjati għall- ewwel darba f’ mudelli sperimentali qabel ma ġew ittestjati fil- bnedmin.
Reproduction is authorised provided the source is acknowledged. studies compared the effects of two doses of Faslodex (either 125 mg or 250 mg every month) with those of anastrozole (another anticancer medicine) taken at a dose of 1 mg every day.
Iż- żewġ studji qabblu l- effetti ta ’ żewġ dożi ta ’ Faslodex (125 mg jew 250 mg kull xahar) ma ’ dawk ta ’ anastrozole (mediċina oħra kontra l- kanċer) meħud f’ doża ta ’ 1 mg kuljum.
In the first study, the patients knew which medicine they were taking, but not in the second study.
Fl- ewwel studju, il- pazjenti kienu jafu liema mediċina kienu qegħdin jieħdu, iżda mhux fit- tieni studju.
In both studies, the main measure of effectiveness was the time until the disease got worse.
Fiż- żewġ studji, il- kejl prinċipali tal- effikaċja kien iż- żmien sakemm il- marda marret għall - agħar.
What benefit has Faslodex shown during the studies?
X’ benefiċċju wera Faslodex matul l- istudji?
Faslodex was at least as effective as anastrozole.
Faslodex kien mill- anqas effettiv daqs anastrozole.
Looking at the results of the two studies taken together, it took an average of 166 days for the disease to get worse in the patients receiving 250 mg Faslodex once a month, compared with 126 days in those taking anastrozole.
Meta wieħed jikkunsidra r- riżultati taż- żewġ studji meħudin f’ daqqa, il- marda ħadet medja ta ’ 166 jum biex tmur għall- agħar fil- pazjenti li rċevew 250 mg Faslodex darba fix- xahar, meta mqabbel ma ’ 126 jum f’ dawk li ħadu anastrozole.
The 250-mg dose of Faslodex was more effective than the 125-mg dose.
Id- doża ta ’ 250 mg Faslodex kienet aktar effettiva mid- doża ta ’ 125 mg.
What is the risk associated with Faslodex?
X’ inhu r- riskju assoċjat ma ’ Faslodex?
The most common side effect with Faslodex (seen in more than 1 patient in 10) is hot flushes.
L- aktar effett sekondarju komuni b’ Faslodex (deher f’ aktar minn 1 minn kull 10 pazjenti) huwa fwawar tal- menopawsa.
For the full list of all side effects reported with Faslodex, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati b’ Faslodex, ara l - Fuljett ta ’ Tagħrif.
Faslodex should not be used in people who may be hypersensitive (allergic) to fulvestrant or any of the other ingredients.
Faslodex m’ għandux jintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għal fulvestrant jew għal xi sustanzi oħra.
Faslodex must not be used in patients who are pregnant or breast-feeding, or in patients who have severe liver disease.
Faslodex m’ għandux jintuża f’ pazjenti li jkunu tqal jew li jkunu qegħdin ireddgħu, jew f’ pazjenti li għandhom mard serju tal- fwied.
Why has Faslodex been approved?
Għaliex ġie approvat Faslodex?
The Committee for Medicinal products for Human Use (CHMP) decided that Faslodex’ s benefits are greater than its risks for the treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Faslodex huma akbar mir- riskji tiegħu għat- trattament ta ’ nisa li qabżu l- menopawsa b’ kanċer tas - sider avvanzat lokalment jew metastatiku pożittiv għar- riċetturi tal- estroġenu għal rikaduta tal- marda waqt jew wara terapija awżiljari antiestroġenu jew progressjoni tal- marda waqt terapija b’ antiestroġenu.
The Committee recommended that Faslodex be given marketing authorisation.
Il- Kumitat irrakkomanda li Faslodex jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Faslodex:
Tagħrif ieħor dwar Faslodex:
The European Commission granted a marketing authorisation valid throughout the European Union for Faslodex to AstraZeneca UK Limited on 10 March 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Faslodex lil AstraZeneca UK Limited fl- 10 ta ’ Marzu 2004.
The marketing authorisation was renewed on 10 March 2009.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fl- 10 ta ’ Marzu 2009.
The full EPAR for Faslodex can be found here.
L- EPAR sħiħ għal Faslodex jista ’ jiġi kkonsultat hawn.
EU number
Għamla
Route of administration
Isem inventat
Content
Qawwa
250 mg/ 5 ml
250mg/ ml
Intramuscular use
Fil- muskolu
5 ml
Siringa diga ’ mimlija
Pre-filled syringe (glass)
5ml
1 pre-filled syringe + 1 safety needle
1 Siringa diġa ’ mimlija 1 safety needle
SUMMARY OF PRODUCT CHARACTERISTICS
KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR.
Faslodex 250 mg solution for injection
Faslodex 250mg soluzzjoni għall- injezzjoni.
One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Siringa diga` mimlija b’ 250mg fulvestrant f’ soluzzjoni ta ’ 5ml.
For a full list of excipients, see section 6.1.
Għal list sħiħa ta’ sustanzi mhux attivi, ara 6. 1
Clear, colourless to yellow, viscous solution.
Soluzzjoni ċara, bla kulur jagħti fl- isfar.
4.1 Therapeutic indications
4. 1 Indikazzjonijiet Terapewtiċi
Faslodex is indicated for the treatment of postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-estrogen therapy or disease progression on therapy with an anti-estrogen.
Faslodex huwa indikat għall- kura fin- nisa, li għaddew mill- menopawża b ’ kanċer tas- sider posittiv għar - riċettur tal- estroġenu, lokalment avvanzat jew metastatiku għall- marda meta tirkadi waqt jew wara terapija miżjuda ta ’ antiestroġenu jew jekk il- marda marret għall- agħar wara terapija b ’ antiestrogenu.
Posology Adult females (including the elderly) The recommended dose is 250 mg at intervals of 1 month.
Id- doża rakkomandata hi ta ’ 250mg b’ intervalli ta ’ xahar.
Paediatric patients Faslodex is not recommended for use in children or adolescents, as safety and efficacy have not been established in this age group.
Pazjenti pedjatriċi Faslodex m ’ għandux jingħata lit- tfal jew adoloxxenti għax is- sigurta u l- effikaċja mhux magħrufin f’ pazjenti ta ’ din l- eta.
Renal impairment No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/ min).
Mhux rakkomandat ebda aġġustament fid- doża għal pazjenti b’ indeboliment tal- kliewi ħafif jew moderat (livell ta ’ tneħħija ta ’ kreatinina ≥ 30 ml/ min).
Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/ min), and, therefore, caution is recommended in these patients (see section 4.4).
Għalhekk għandha tintuża kawtela f’ dawn il- pazjenti( ara sezzjoni 4. 4).
Hepatic impairment No dose adjustments are recommended for patients with mild to moderate hepatic impairment.
Mhux rakkomandat ebda aġġustament fid- doża għal pazjenti b’ indeboliment tal- fwied ħafif jew moderat.
However, as fulvestrant exposure may be increased, Faslodex should be used with caution in these patients.
Madankollu peress li l- espożizzjoni għal fulvestrant tista tiżdied, Faslodex irid jintuża b’ kawtela f’ dawn il- pazjenti.
There are no data in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
M’ hemm l- ebda data fuq pazjenti b’ indeboliment serju tal- fwied (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
Method of administration Faslodex should be administered by slow intramuscular injection into the buttock.
Faslodex għandu jingħata b’ injezzjoni, bil- mod, fil- muskolu tal- warrani.
For detailed instructions for administration, see section 6.6.
Għall- informazzjoni sħiħa dwar kif għandu jingħata ara sezzjoni 6. 6.
4.3 Contraindications
2 4. 3 Kontra- indikazzjonijiet
Hypersensitivity to the active substance, or to any of the other excipients.
Sensittivitta eċċessiva għas- sustanza attiva jew għal xi sustanzi oħra mhux attivi
Pregnancy and lactation (see section 4.6) Severe hepatic impairment (see sections 4.4 and 5.2).
Indeboliment serju tal- fwied (ara sezzjoni 4. 4 u 5. 2)
2 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
Faslodex should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Faslodex għandu jintuża b’ kawtela f’ pazjenti sezzjoni 4. 2, 4. 3 u 5. 2).
Faslodex should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/ min)
(ara sezzjoni 5. 2).
Due to the intramuscular route of administration, Faslodex should be used with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment.
Minħabba li jingħata ġewwa l- muskolu, Faslodex għandu jintuża b’ kawtela f’ pazjenti li jbagħtu minn emorraġija dijatesi, tromboċitopenia jew li qed jingħataw xi medicina anti- koagulanti.
Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical trials with Faslodex (see section 4.8).
Każi tromboemboliċi huma osservati ta ’ spiss f’ nisa b’ kanċer tas- sider avvanzat u ġew osservati fi provi kliniċi b’ Faslodex (ara sezzjoni 4. 8).
This should be taken into consideration when prescribing Faslodex to patients at risk.
Dan għandu jiġi ikkonsidrat meta Faslodex jiġi ordnat f’ pazjenti b’ riskju.
There are no long-term data on the effect of fulvestrant on bone.
M’ hemm l- ebda data fuq l- effett fit- tul ta ‘ fulvestrant fuq l- għadam. fulvestrant hemm riskju potenzjali ta ’ osteoporosi.
Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.
Minħabba l- mod kif jaħdem
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l - effet farmaċewtiku tal- prodott
A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4.
Studju kliniku fuq l- interazzjoni ma ’ midazolam (substrat ta ’ CYP3A4) wera li fulvestrant ma jfixkilx CYP3A4.
Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance.
Riżultati li ħarġu minn studji kliniċi, fuq l- interazzjoni ma ’ rifampiċin (iżid l- attivita` ta ’ CYP 3A4) u ma ketoconazole (inibitur potenti ta ’ CYP 3A4), ma wrew l- ebda evidenza ta ’ tibdil klinikament relevanti fit- tneħħija ta ’ fulvestrant.
Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly.
Aġġustar fid- doża mhux meħtieġ f’ dawk il- pazjenti li jingħataw fulvestrant flimkien ma mediċini li jinibixxu jew iżidu l- attivita ta’ CYP3A4.
4.6 Pregnancy and lactation
4. 6 Tqala u Treddiegħ
Faslodex is contraindicated in pregnancy (see section 4.3).
Faslodex huwa kontra- indikat waqt it- tqala (ara sezzjoni 4. 3).
Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit.
Ġi muri li Fulvestrant jgħaddi mill- plaċenta wara li ngħatat doża waħda intramaskulari fil- firien u l- fniek.
If pregnancy occurs while taking Faslodex, the patient must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy.
Studji fuq annimali wrew evidenza ta ’ tossiċita` fis- sistema riproduttiva li inkludew żieda fil- każi ta ’ annormalitajiet u mwiet tal- fetu (ara sezzjoni 5. 3). Pazjenti f ’ eta li jista jkollhom it- tfal għandhom jiġu avżati giex jużzaw metodi effettivi ta ’ kontraċezzjoni waqt li jkunu fuq it- trattament. Mara li tkun qed tieħu Faslodex li tinqabad tqila għandha tiġi informata bl- effetti ħżiena fuq il- fetu kif ukoll bir- riskju li tkorri t- tqala.
Fulvestrant is excreted in milk in lactating rats.
Fulvestrant jiġi eliminat fil- ħalib fil- firien fi żmien it- treddigħ.
It is not known whether fulvestrant is excreted in human milk.
Mhux magħruf jekk fulvestrant jiġi eliminat fil- ħalib uman.
Considering the potential for serious adverse reactions due to fulvestrant in breast-fed infants, lactation is contraindicated (see section 4.3).
(ara sezzjoni 4. 3)
4.7 Effects on ability to drive and use machines
3 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Faslodex has no or negligible influence on the ability to drive or use machines.
Faslodex m’ għandu l- ebda effett jew ftit li xejn fuq il- ħila biex issuq u tħaddem magni.
However, since asthenia has been reported commonly with Faslodex, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery.
Iżda minħabba li astenja kienet rappurtata b’ mod komuni b’ Faslodex. il pazjent li esperjenzaw din ir- reazzjoni avversa għandhom joqgħodu attenti waqt is- sewqan u l- użu ta’ magni.
This section provides information based on all adverse reactions from clinical trials, post-marketing studies or spontaneous reports.
Din is- sezzjoni tipprovid informazzjoni fuq ir- reazzjonijiet avversi kollha minn provi kliniċi, studji ta ’ wara t- tqegħid fis- suq u rapporti spontanji.
Approximately 47% of patients experienced adverse reactions in the clinical trial programme.
Madwar 47% ta ’ pazjenti kellhom reazzjoni avversa waqt il - programm ta ’ provi kliniċi.
However, only 0.9% of patients stopped therapy because of an adverse reaction.
Iżda, 0. 9% biss mill pazjenti waqqfu l- użu tal- medicina minħabba xi reazzjoni avversa.
The most frequently reported adverse reactions are hot flushes, nausea, and injection site reactions.
Ir- reazzjonijiet avversi irrapportati l- aktar frekwenti huma fwawar ta ’ sħana, dardir u xi reazzjoni fil- post ta ’ l- injezzjoni.
Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Ir - reazzjonijiet avversi elenkati huma klassifikati skond il - frekwenza u l- klassi tas- sistema ta ’ l- organu (SOC).
Frequency groupings are defined according to the following convention:
Il- gruppi tal- frekwenza huma definiti skond il- konvenzjoni:
Very common (≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100).
Komuni ħafna (> 1/ 10), Komuni (> 1/ 100, < 1/ 10), Mhux komuni (> 1/ 1000, < 1/ 100).