qanastek/EMEA-V3 huggingface dataset:
CARTON FOR BLISTER PACK (30 film-coated tablets)
IL- KARTUNA TAL- PAKKETT TAL- FOLJI (30 pillola miksija b’ rita)
30 film-coated tablets
30 pillola miksija b’ rita
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR BLISTER PACK (7 film-coated tablets)
IL- KARTUNA TAL- PAKKETT TAL- FOLJI (7 pilloli miksija b’ rita)
7 film-coated tablets
7 pilloli miksija b’ rita
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR BLISTER PACK (28 film-coated tablets)
IL- KARTUNA TAL- PAKKETT TAL- FOLJI (28 pillola miksija b’ rita)
34 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
36 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER - 28 tablets
FOLJA - 28 pillola
Mon
It- Tnejn
Tue
It- Tlieta
Wed
L- Erbgħa
Thu
Il- Ħamis
Fri
Il- Ġimgħa
Sat
Is- Sibt
Sun
Il- Ħadd
BOTTLE LABEL
IT- TABELLA TAL- FLIXKUN
For oral use
Għall- użu orali
BLISTER - 7 tablets
FOLJA - 7 pilloli
37 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
39 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER - 30 tablets
FOLJA - 30 pillola
39 PACKAGE LEAFLET:
41 FULJETT TA ’ TAGĦRIF:
FABLYN 500 microgram film-coated tablets lasofoxifene
FABLYN 500 mikrogramma p illoli miksija b’ rita lasofoxifene
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina. • Żomm dan il- fuljett.
What FABLYN is and what it is used for 2.
X’ inhu FABLYN u għalxiex jintuża 2.
Before you take FABLYN 3.
Qabel ma tieħu FABLYN 3.
How to take FABLYN 4.
Kif għandek tieħu FABLYN 4.
How to store FABLYN 6.
Kif taħżen FABLYN 6.
WHAT FABLYN IS AND WHAT IT IS USED FOR
X’ INHU FABLYN U GĦALXIEX JINTUŻA
FABLYN is used to treat osteoporosis in women after the menopause (postmenopausal osteoporosis) who are likely to break bones, especially in the spine, hips and wrists.
FABLYN jintuża biex jikkura l- osteoporożi fin- nisa wara l- menopawsa (osteoporożi ta ’ wara l- menopawsa), li huma suxxettibbli għall- ksur tal- għadam, speċjalment fl- ispina, fil- ġenbejn u fil- polz tal- idejn.
It belongs to a group of medicines called Selective Estrogen Receptor Modulators (SERM).
Dan jifforma parti minn kategorija ta ’ mediċini msejħa Modulaturi Selettivi tar- Riċetturi tal- Estroġenu (SERM).
In women with postmenopausal osteoporosis, FABLYN reduces the risk of both fractures of the spine (vertebral fractures) and non-spine fractures (non-vertebral fractures), but not hip fractures.
Fin- nisa li jkollhom osteoporożi ta ’ wara l- menopawsa, FABLYN inaqqas ir- riskju kemm ta ’ ksur fl- ispina (ksur vertebrali), kif ukoll ta ’ ksur mhux fl- ispina (ksur mhux vertebrali), iżda mhux ta ’ ksur fil- ġenbejn.
BEFORE YOU TAKE FABLYN
QABEL MA TIEĦU FABLYN
Do not take FABLYN • if you are allergic (hypersensitive) to lasofoxifene or any of the other ingredients of FABLYN. • if you currently have or previously had blood clots, for example in your veins, lungs or eyes (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis). • if you have any vaginal bleeding.
Tieħux FABLYN • jekk inti allerġika (tbati minn sensittività eċċessiva) għal lasofoxifene jew sustanzi oħra ta ’ FABLYN. • jekk għandek jew kellek emboli, per eżempju fil- vini, fil- pulmun jew fl- għajnejn (trombożi fil- vini l- fondi, emboliżmu pulmonari jew trombożi tal- vina tar- retina. jekk kellek ħruġ ta ’ demm mill- vaġina.
This must be investigated by your doctor before starting treatment. • if you could still become pregnant. • if you are pregnant or breast-feeding.
Dan għandu jiġi nvestigat mit- tabib tiegħek qabel ma • tibda l- kura. • jekk għadek tista ’ tinqabad tqila. • jekk inti tqila jew qiegħda tredda ’.
40 Take special care with FABLYN • if you are immobile for some time, such as, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an illness, as these may increase your risk of blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
42 Oqgħod attent ħafna b ’ FABLYN jekk għal xi perjodu ma tistax tiċċaqlaq, bħal per eżempju, għandek bżonn tiddaħħal l- isptar • jew toqgħod fis- sodda biex tieħu saħħtek wara operazzjoni jew wara xi marda, għax dan jista ’ jżidlek ir- riskju li jkollok l- emboli (trombożi tal- vini l- fondi, emboliżmu pulmonari jew trombożi tal- vina tar- retina).
Your doctor may recommend that you stop treatment at least 3 weeks prior to this time.
It- tabib tiegħek jista jirrakkomandalek li twaqqaf il- kura mill- inqas 3 ġimgħat qabel dan il- perjodu.
Treatment with FABLYN can be restarted as soon as you regain your mobility and in consultation with your doctor.
Il- kura b’ FABLYN tista ’ terġa ’ tinbeda hekk kif inti terġa ’ tkun tista ’ tiċċaqlaq u wara li tkun ikkonsultajt mat- tabib tiegħek.
• if you are taking FABLYN, you should walk around or exercise your legs and feet at regular intervals when traveling long distances.
• jekk qiegħda tieħu FABLYN, meta tkun qiegħda tivjaġġa distanzi twal, int għandek tqum tippassiġġa jew tagħmel eżerċizzju għal riġlejk u saqajk f’ intervalli regolari.
This is because sitting for a long time in the same position may prevent good blood circulation and may increase your risk of blood clots.
Dan għaliex il- fatt li int tkun bilqiegħda fl- istess pożizzjoni għal perjodu ta ’ ħin twil jista ’ jtellef iċ- ċirkolazzjoni tad- demm u jista ’ jżidlek ir- riskju li jkollok l- emboli.
It is unlikely that FABLYN will cause vaginal bleeding.
Il- possibilta ’ li FABLYN jikkawża ħruġ ta ’ demm mill- vaġina hija remota.
So any vaginal bleeding while you take FABLYN is unexpected.
Għalhekk, mhuwiex mistenni li jkollok ħruġ ta ’ demm mill- vaġina waqt li tkun qiegħda tieħu FABLYN.
You should have this investigated by your doctor.
Jekk jiġri dan, għandek tistħarreġ dwar ir- raġuni mat- tabib tiegħek.
The following are reasons why this medicine may not be suitable for you.
Il- punti li ġejjin huma raġunijiet għaliex din il- mediċina tista ’ ma tkunx tajba għalik.
You should talk to your doctor before starting to take FABLYN:
Għandek tkellem lit- tabib tiegħek qabel ma tibda tieħu FABLYN:
• if you have or have had breast cancer. • if you experience any unexplained breast abnormality. • if you have severe liver disease. • if you have severe kidney disease.
• jekk għandek jew kellek kanċer tas- sider. • jekk tħoss xi anormalità f’ sidrek li m’ għandekx spjegazzjoni għaliha. • jekk għandek mard serju tal- fwied. • jekk għandek mard serju tal- kliewi.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħda tieħu jew ħadt dan l- aħħar xi mediċini oħra, anke dawk mingħajr riċetta.
If you are taking estrogen replacement therapy (ERT) or hormone replacement therapy (HRT), FABLYN may not be suitable for you.
Jekk qiegħda tieħu terapija li tissostitwixxi l- estroġenu (ERT) jew terapija li tissostitwixxi l- ormoni (HRT), FABLYN jista ’ ma jkunx tajjeb għalik.
Taking FABLYN with food and drink FABLYN can be taken with or without food and drink.
Meta tieħu FABLYN ma ’ l- ikel u max- xorb FABLYN jista ’ jittieħed ma l- ikel u x- xorb jew waħdu.
Pregnancy and breast-feeding FABLYN is only for women after the menopause and must not be taken by women who can still become pregnant.
Tqala u treddigħ FABLYN huwa indikat biss għall- użu min- nisa wara li jkunu għaddew mill- menopawsa u m’ għandux jittieħed min- nisa li għad jistgħu jinqabdu tqal.
Do not take FABLYN if you are pregnant or breast-feeding as it might be excreted in mother’ s milk.
Tiħux FABLYN jekk inti tqila jew qiegħda tredda ’ għax dan jista ’ joħroġ mal- ħalib tas- sider tal- omm.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
FABLYN has no known influence on the ability to drive and use machines.
FABLYN m’ għandu l- ebda effett magħruf fuq il- ħila biex issuq jew tħaddem magni.
Important information about some of the ingredients of FABLYN FABLYN contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ FABLYN FABLYN fih il- lattosju.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek infurmak li ġismek ma jittollerax ċerti tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE FABLYN
KIF GĦANDEK TIEĦU FABLYN
Always take FABLYN exactly as your doctor has told you.
Dejjem għandek tieħu FABLYN skont il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew mal- ispiżjar tiegħek jekk ikollok xi dubju.
The usual dose is one tablet each day.
Id- doża li ssoltu tingħata hija pillola waħda kuljum.
41 Swallow the tablet whole.
Ibla ’ l- pillola sħiħa.
You may take it with or without food.
Tista ’ toħodha ma ’ l- ikel jew mhux ma ’ l- ikel.
If you wish, you may take it with water or another beverage of choice.
Jekk tkun trid, tista ’ tieħu l- pillola ma ’ l- ilma jew ma ’ kwalunkwe xarba li tixtieq.
Your doctor may also advise you to take Calcium and Vitamin D supplements while you are treated with FABLYN if your daily intakes are not considered sufficient.
It- tabib tiegħek jista ’ jgħidlek biex tieħu s- supplimenti tal- Kalċju u l- Vitamina D waqt li inti tkun qiegħda tieħu l- kura b’ FABLYN jekk hu jkun tal- fehma li int ma tiħux Kalċju u Vitamina D daqs kemm sippost tieħu f’ ġurnata.
If you take more FABLYN than you should If you take more tablets than you should, tell your doctor or pharmacist.
Jekk tieħu FABLYN aktar milli suppost Jekk tieħu aktar pilloli milli sippost, għid lit- tabib jew lill- ispiżjar tiegħek.
If you forget to take FABLYN Do not take a double dose to make up for a forgotten tablet.
Jekk tinsa tieħu FABLYN M’ għandekx tieħu doża doppja biex tpatti għal kull pillola li tkun insejt tieħu.
Take your next tablet and continue as before.
Ħu l- pillola li jmiss u kompli l- kura bħal ma kont qiegħda tagħmel.
If you stop taking FABLYN You should talk to your doctor before stopping FABLYN.
Jekk tieqaf tieħu FABLYN Għandek tkellem lit- tabib tiegħek qabel tieqaf tieħu FABLYN.
Like all medicines, FABLYN can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, FABLYN jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most of the side effects that occurred during studies were mild.
Ħafna mill- effetti sekondarji li dehru waqt l- istudji li saru b’ FABLYN kienu ħfief.
These side effects may occur with certain frequencies, which are defined as follows:
Dawn l- effetti sekondarji jistgħu jidhru b’ ċerti frekwenzi, li huma definiti kif ġej:
• Very common: affects more than 1 user in 10 • Common: affects 1 to 10 users in 100 • Uncommon: affects 1 to 10 users in 1,000 • Rare: affects 1 to 10 users in 10,000 • Very rare: affects less than 1 user in 10,000 • Not known: frequency cannot be estimated from the available data
• Effetti sekondarji komuni ħafna: jaffetwaw aktar minn pazjent 1 minn kull 10 • Komuni: jaffetwaw minn pazjent 1 sa 10 minn kull 100 • Mhux komuni: jaffetwaw minn pazjent 1 sa 10 minn kull 1, 000 • Rari: jaffetwaw minn pazjent 1 sa 10 minn kull 10, 000 • Rari ħafna: jaffetwaw inqas minn pazjent 1 minn kull 10, 000 • Mhux magħrufa: il- frekwenza ma tistax tiġi kkalkulata mill- informazzjoni eżistenti
Very common side effects:
Effetti sekondarji komuni ħafna:
• Muscle cramps
• Bugħawwieġ fil- muskoli
Common side effects:
Effetti sekondarji komuni:
• Hot flush • Constipation • Pressure in the lower abdomen • Vaginal discharge • Excessive sweating
• Fawra tal- menopawsa • Stitikezza • Pressjoni fuq in- naħa ta’ isfel taż- żaqq • Tnixxija mill- vaġina • Ħruġ eċċessiv ta ’ għaraq
42 Uncommon side effects:
44 Effetti mhux komuni:
• Urinary tract infection, burning on urination, urgent need to urinate, urinary incontinence • Abdominal pain or pressure, pain in the back, neck, joints or chest • Tiredness, abnormal or excessive bleeding commonly from the nose • Diabetes (typical symptoms are excessive thirst, frequent urination) • Burning sensation, dizziness, numbness, memory impairment, impaired or partial loss of movement of a limb, headache, restless legs syndrome (an irresistible urge to move legs to stop an uncomfortable or odd sensations) • Abnormal or irregular beating of the heart, increased heart rate • Swelling of hands, arms, feet or legs, limb pain • Cough, difficulty breathing, stuffy nose, runny nose • Dry mouth, flatulence (excessive amount of air or gases in the stomach or the intestine), stomach ache • Dry eye, hair loss, skin rash, night sweats, itching, feeling hot, weight gain • Breast stiffening, breast pain, vaginal bleeding, genital itching
• Infezzjoni fis- sistema urinarja, sensazzjoni ta ’ ħruq meta tagħmel l- awrina, tħoss b’ urġenza l- ħtieġa biex tagħmel l- awrina, ma jkollokx kontroll fuq l- għamil tal- awrina • Uġigħ addominali jew sensazzjoni ta ’ pressjoni, uġigħ fid- dahar, fl- għonq, fil- ġogi jew fis- sider • Għeja, ħruġ ta ’ demm anormali jew eċċessiv, ħafna drabi mill- imnieħer • Dijabete (is- sintomi tipiċi huma: ħafna għatx, għamil frekwenti tal- awrina) • Sensazzjoni ta ’ ħruq, sturdament, tirżiħ, telf tal- memorja, telf totali jew parzjali tal- ħila li ċċaqlaq xi riġel jew driegħ, uġigħ ta ’ ras, sindromu li ma jkollokx kwiet f’ riġlejk (tħoss ħtieġa urġenti li ċċaqlaq riġlejk biex twaqqaf sensazzjonijiet skomdi jew strambi) • Taħbit tal- qalb anormali jew irregolari, taħbit tal- qalb aktar mgħaġġel • Nefħa fl- idejn, fid- dirgħajn, saqajn jew riġlejn, uġigħ fid- dirgħajn u fir- riġlejn • Sogħla, diffikultà biex tieħu n- nifs, imnieħer miżdud, flisjoni • Ħalq xott, gass fl- istonku (ammont eċċessiv ta ’ arja jew gassijiet fl- istonku jew fl- imsaren), uġigħ fl- istonku • Għajnejn xotti, taqa ’ x- xagħar, raxx fil- ġilda, tkun għarqan bil- lejl, ħakk, tħoss is- sħana, tiżdied fil- piż • Ebusija tas- sider, uġigħ fis- sider, ħruġ ta ’ demm mill- vaġina, ħakk fl- organu ġenitali
Rare side effects:
Effetti sekondarji rari li:
• Infection in the ear, eye, respiratory tract or skin, diarrhea, blood in stools • Change in appetite • Abnormal dreams, mood swings • Dizziness, altered sense of taste, seizures, migraine, weakness of arms or legs, sciatica (pain felt in the lower back, buttock, and/ or various parts of the leg and foot; typically on one side of the body) • Impaired vision, pain in eyes, itchy eyes, swollen eyelids, redness of the eyes, ear pain • Lip lesions, change of bowel habits, difficulty swallowing, mouth ulcer, heart burn, mouth pain, anal pain • Jaundice (yellowing of the skin and eyes), changes in blood tests of liver function • Dry skin, unusual hair texture, nail disorder, skin rash, skin darkening, altered shape of fingers, skin lesion • Painful urination, blood in urine • Breast discharge, breast lump, vaginal pain, varicose vein • Decreased pulse in feet, bruising
• Infezzjoni fil- widnejn, l- għajnejn, fis- sistema respiratorja jew fil- ġilda, dijarea, demm fl- iskart tal- ġisem • Bidla fl- aptit • Ħolm anormali, tibdil fil- burdata • Sturdament, bidla fis- sens tat- togħma, attakk ta ’ puplesija, emigranja, dgħufija fid- dirgħajn u fir- riġlejn, xjatika (uġigħ fin- naħa ta ’ isfel tad- dahar, il- warrani, u/ jew partijiet differenti tar- riġel u s- sieq; tipikament fuq naħa waħda tal- ġisem) • Vista mgħarrqa, uġigħ fl- għajnejn, ħakk fl- għajnejn, nefħa fl- għotjin tal- għajnejn, ħmura fl- għajnejn, uġigħ fil- widnejn • Feriti fix- xofftejn, bidla fil- ħinijiet ta ’ meta inti tipporga, diffikultà biex tibla ’, ulċera fil- ħalq, ħruq ta ’ stonku, uġigħ fil- ħalq, uġigħ anali • Suffejra (sfurija fil- ġilda u fl- għajnejn), bidla fit- testijiet tad- demm tal- funzjoni tal- fwied • Ġilda xotta, mod mhux tas- soltu kif jinħass ix- xagħar, disturbi fid- dwiefer, raxx fil- ġilda, il- ġilda tiskura, tibdil fil- forma tas- swaba ’, feriti fil- ġilda • Uġigħ meta tagħmel l- awrina, demm fl- awrina • Tnixxija mis- sider, boċċa fis- sider, uġigħ fil- vaġina, vini varikużi • Tnaqqis kbir ħafna fit- taħbit tal- polz fis- saqajn, tbenġil
HOW TO STORE FABLYN
KIF TAĦŻEN FABLYN
Do not use FABLYN after the expiry date which is stated on the blister or bottle label and on the carton after “ EXP :”.
Tużax FABLYN wara d- data ta ’ skadenza li tidher fuq il- folja jew it- tikketta tal- flixkun u fuq il- kartuna wara “ JIS: ”.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar..
What FABLYN contains • The active substance is lasofoxifene.
X’ fih FABLYN: • Is- sustanza attiva hi lasofoxifene.
Each film-coated tablet contains lasofoxifene tartrate, equivalent to 500 micrograms of lasofoxifene.
Kull pillola miksija b’ rita fiha lasofoxifene tartrate, ekwivalenti għal 500 mikrogramma lasofoxifene.
• The other ingredients are lactose anhydrous; microcrystalline cellulose; croscarmellose sodium; silica, colloidal anhydrous; magnesium stearate; sunset yellow FCF aluminium lake (E110); hypromellose; lactose monohydrate; titanium dioxide (E171) and triacetin.
• Is- sustanzi l- oħra huma lactose anhydrous; microcrystalline cellulose; croscarmellose sodium; silica; colloidal anhydrous; magnesium stearate; FCF aluminium lake (E110) ta ’ lewn isfar kulur inżul ix- xemx; hypromellose; lactose monohydrate; titanium dioxide (E171) u triacetin.
What FABLYN looks like and contents of the pack FABLYN tablets are triangular, peach coloured, film-coated tablets marked with “ Pfizer” on one side and “ OPR 05” on the other.
Il- pilloli FABLYN huma trijangulari, kulur il- ħawħa, u miksija b’ rita, b ’ ” Pfizer ” immarkata fuq naħa waħda u “ OPR 05 ” fuq in- naħa l- oħra.
The tablets are provided in blister packs containing 7, 28 or 30 tablets, and in bottle packs containing 90 tablets.
Il- pilloli jiġu ġo pakkett tal- folji li jkun fih 7, 28 jew 30 pillola, u f’ pakkett bi flixkun li jkun fih 90 pillola.
Not all pack sizes may be marketed.
Mhux il- pakketti tad- daqsijiet kollha huma għal skop kummerċjali.
Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom.
Id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- suq huwa Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, Ir- Renju Unit.
The Manufacturer is Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Germany.
Il- Manifattur huwa Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Il- Ġermanja.
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:
44 Pfizer Tél: +33 (0)1 58 07 34 40 Ireland Pfizer Healthcare Ireland Tel: + 1800 633 363
46 Pfizer Tél: +33 (0) 1 58 07 34 40 Ireland Pfizer Healthcare Ireland Tel: + 1800 633 363
What is Fabrazyme?
X' inhu Fabrazyme?
Fabrazyme is a solution for infusion (drip into a vein) containing the active substance agalsidase beta.
Fabrazyme hu soluzzjoni għall- infużjoni (drip fil- vina) li fiha s- sustanza attiva agalsidażi beta (agalsidase beta).
What is Fabrazyme used for?
Għal xiex jintuża Fabrazyme?
Fabrazyme is used to treat patients who have Fabry disease, a rare inherited disorder.
Fabrazyme jintuża biex jittrata pazjenti li jbatu bil- marda ta 'Fabry, marda rari li tintiret.
Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A.
Il- pazjenti li jbatu bil- marda ta 'Fabry ikollhom nuqqas ta' l- enżima, alfa- galattosidaże A (alpha- galactosidase A).
This enzyme normally breaks down a fatty substance called globotriaosylceramide (GL-3).
Din l- enżima normalment tkisser is- sustanza xaħmija msejħa globotrijaosilċeramide (globotriaosylceramide) (GL3).
If the enzyme is not present, GL-3 cannot be broken down and it builds up in the body’ s cells, such as kidney cells.
Jekk din l- enżima ma tkunx preżenti, il- GL3 ma tistax titkisser u tinġema 'fiċ- ċelloli tal- ġisem, bħal f' dawk tal- kliewi.
People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems and stroke.
Il- persuni li jbatu minn din il- marda jistgħu jkollhom firxa sħiħa ta 'sinjali u sintomi, li jinkludu kundizzjonijiet gravi bħal ħsara fil- kliewi, problemi tal- qalb u puplesija.
Because the number of patients with Fabry disease is low, the disease is considered ‘ rare’, and Fabrazyme was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 8 August 2000.
Peress li n- numru ta 'pazjenti li jbatu mill- marda ta' Fabry huwa wieħed baxx, il- marda hi kkunsidrata bħala 'rari', u, fit- 8 ta' Awissu 2000, Fabrazyme ġie msejjaħ bħala 'mediċina orfni' (mediċina użata f' mard rari).
How is Fabrazyme used?
Kif jintuża Fabrazyme?
Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Fabrazyme.
Fabrazyme għandu jingħata biss minn tabib li għandu esperjenza fil- kura ta 'pazjenti bil- marda ta' Fabry jew mard metaboliku ieħor li jintiret.
It is used as an intravenous infusion of 1 mg per kilogram body weight given once every two weeks.
Jintuża bħala infużjoni fil- vina ta '1 mg għal kull kg piż tal- ġisem mogħti darba kull ġimagħtejn.
The starting infusion rate should be no more than 0.25 mg per minute (15 mg per hour) to reduce the risk of infusion-related side effects.
Ir- rata tal- bidu ta 'l- infużjoni ma għandhiex tkun ta' aktar minn 0. 25 mg/ min (15 mg/ siegħa) biex jitnaqqas ir- riskju ta 'effetti sekondarji relatati ma' l- infużjoni.
The infusion rate may be increased gradually with further infusions.
Ir- rata ta 'l- infużjoni tista' tiżdied gradwalment meta jingħataw aktar infużjonijiet.
One study has looked at what happens to Fabrazyme when given to children and suggested that Fabrazyme could be used in children between eight and 16 years of age at the same dose.
Sar studju dwar x' jiġri lil Fabrazyme meta jingħata lit- tfal u rriżulta li Fabrazyme jista 'jintuża fi tfal bejn tmienja u 16 - il sena bl- istess doża.
Patients who have severe kidney damage may have a weaker response to treatment.
Il- pazjenti li għandhom ħsara gravi fil- kliewi jista 'jkollhom rispons aktar dgħajjef għat- trattament.
Fabrazyme is intended for long-term use.
Fabrazyme hu maħsub għal użu fit- tul.
How does Fabrazyme work?
Kif jaħdem Fabrazyme?
Fabrazyme is an enzyme replacement therapy.
Fabrazyme hu terapija enżimatika sostituttiva.
Enzyme replacement therapies provide patients with the enzyme they are lacking.
Din it- tip ta 'terapija tipprovdi lill- pazjenti bl- enżima li tagħha għandhom nuqqas.
Fabrazyme is designed to replace the human enzyme alpha-galactosidase A, which people with Fabry disease are lacking.
Fabrazyme hu maħsub sabiex jissostitwixxi l- enżima umana, alfa - galattosidaże A, li hi nieqsa fil- persuni li jbatu mill- marda ta 'Fabry.
The active substance in Fabrazyme, agalsidase beta, is a copy of the human enzyme, produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce the enzyme.
Is- sustanza attiva fi Fabrazyme, agalsidażi beta, hi kopja ta 'l- enżima umana, prodotta b' metodu magħruf bħala' teknoloġija
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. rikombinanti tad- DNA ': l- enżima tiġi prodotta minn ċellula li tkun ingħatat ġene (DNA), li jagħmel il - produzzjoni ta' l- enżima possibbli.
How has Fabrazyme been studied?
Kif ġie studjat Fabrazyme?
Three clinical studies involving a total of 73 adult patients were presented.
Ġew ippreżentati tliet studji kliniċi li involvew total ta '73 pazjent adult.
In the main study, Fabrazyme was compared with placebo (a dummy treatment) in 58 patients.
Fl- istudju prinċipali, Fabrazyme tqabbel mal- plaċebo (trattament finta) fi 58 pazjent.
The study looked at the effect of the medicines on clearing GL-3 from the kidney.
L- istudju eżamina l- effett tal- mediċini fuq it- tneħħija tal- GL- 3 mill- kilwa.
The effectiveness of Fabrazyme was also tested in 16 children aged between eight and 16 years who had Fabry disease.
L- effikaċja ta 'Fabrazyme ġiet ukoll ittestjata f' 16- il tifel u tifla ta' età bejn tmienja u 16- il sena li jbatu bil- marda ta 'Fabry.
What benefit has Fabrazyme shown during the studies?
X' benefiċċju wera Fabrazyme matul l- istudji mwettqa?
In the main study, Fabrazyme produced a highly significant and almost complete clearance of GL-3 in the kidney cells after 20 weeks of treatment:
Fl- istudju prinċipali, Fabrazyme neħħa sa punt sinifikanti ħafna u kważi komplut il- GL- 3 miċ- ċelluli tal- kliewi wara 20 ġimgħa ta 'trattament:
69% of the patients treated with Fabrazyme had the best score for clearance, compared with none of the patients in the placebo group.
69% tal- pazjenti ttrattati bi Fabrazyme irreġistraw l- aħjar livelli ta 'tneħħija, meta mqabbla ma' l- effetti nulli fil- pazjenti tal- grupp tal- plaċebo.
This might lead to the symptoms of the disease improving or the disease becoming stable.
Dan jista 'jwassal biex is- sintomi tal- marda jitjiebu jew biex il- marda ssir stabbli.
Children treated with Fabrazyme also had decreases in levels of GL-3 in the blood, with all children having normal levels after 20 weeks of treatment.
It- tfal ittrattati b' Fabrazyme ukoll kellhom tnaqqis fil- livelli ta 'GL- 3 fid- demm, bit- tfal kollha jkollhom livelli normali wara 20 ġimgħa ta' trattament.
This was accompanied by improvements in the children ’ s symptoms and quality of life.
Dan kien akkumpanjat b' titjib fis- sintomi u fil - kwalità tal- ħajja tat- tfal.
What is the risk associated with Fabrazyme?
X' inhu r- riskju assoċjat ma 'Fabrazyme?
The most common side effects with Fabrazyme (seen in more than 1 patient in 10) are caused by the infusion rather than the medicine.
L- aktar effetti sekondarji komuni b' Fabrazyme (li dehru f' aktar minn pazjent 1 minn 10) huma kkawżati mill- infużjoni aktar milli mill- mediċina.
These reactions are mainly fever and chills.
Dawn ir- reazzjonijiet huma prinċipalment deni u rjieħat.
Other very common side effects include headache, paraesthesia (abnormal sensations like pins and needles), nausea (feeling sick), vomiting, flushing and feeling cold.
Effetti sekondarji oħra komuni ħafna jinkludu wġigħ ta 'ras, paraestesija (sensazzjonijiet anomali bħat- tnemnim), nawżea (dardir), remettar, fwawar u bard.
Side effects reported in children are similar to those seen in adult patients.
L- effetti sekondarji rrappurtati fi tfal huma simili għal dawk murija f' pazjenti adulti.
For the full list of all side effects reported with Fabrazyme, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrappurtati b' Fabrazyme, ara l- Fuljett ta' Tagħrif.
Patients who receive Fabrazyme can develop antibodies (proteins that are produced in response to Fabrazyme and can affect treatment).
Il- pazjenti li jieħdu Fabrazyme jistgħu jiżviluppaw antikorpi (proteini prodotti bħala risposta għal Fabrazyme u jistgħu jaffettwaw it- trattament).
Fabrazyme should not be used in people who may be hypersensitive (allergic) to agalsidase beta or any of the other ingredients.
Fabrazyme ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għall- agalsidażi beta jew għal xi ingredjenti oħra.
Why has Fabrazyme been approved?
Għaliex Fabrazyme ġie approvat?
The Committee for Medicinal Products for Human Use (CHMP) decided that, for patients with Fabry disease, treatment with Fabrazyme might provide long-term clinical benefits.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li, għal pazjenti bil - marda ta 'Fabry, it- trattament b' Fabrazyme jista' jipprovdi benefiċċji kliniċi fuq medda twila ta 'żmien.
The CHMP decided that Fabrazyme’ s benefits are greater than its risks for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.
Is- CHMP iddeċida li l- benefiċċji ta 'Fabrazyme jegħlbu r- riskji tiegħu għat- terapija enżimatika sostituttiva fuq medda twila ta' żmien f' pazjenti bi djanożi konfermata tal- marda ta 'Fabry.
The Committee recommended that Fabrazyme be given marketing authorisation.
Il- Kumitat irrakkomanda li Fabrazyme jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Fabrazyme was originally authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, limited information was available at the time of approval.
Fabrazyme kien oriġinarjament awtorizzat taħt "Ċirkostanzi ta 'Eċċezzjoni", għax, minħabba li l - marda hija rari, kien hemm disponibbli biss tagħrif limitat fi żmien l- approvazzjoni.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 6 February 2008.
Billi l- kumpanija pprovdiet it- tagħrif addizzjonali mitlub, iċ - "Ċirkostanzi ta 'Eċċezzjoni" ntemmu fis- 6 ta' Frar 2008.
Other information about Fabrazyme:
Tagħrif ieħor dwar Fabrazyme:
The European Commission granted a marketing authorisation valid throughout the European Union for Fabrazyme to Genzyme Europe B. V. on 3 August 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Fabrazyme, għal Genzyme Europe B. V. fit- 3 ta 'Awissu 2001.
The marketing authorisation was renewed on 3 August 2006.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fit- 3 ta 'Awissu 2006.
The record of Fabrazyme’ s designation as an orphan medicine is available here.
Ir- reġistru tad- deżinjazzjoni ta 'Fabrazyme bħala mediċina orfni huwa disponibbli hawn.
The full EPAR for Fabrazyme can be found here.
L- EPAR sħiħ għal Fabrazyme jista 'jinkiseb minn hawn.
Fabrazyme 35 mg, powder for concentrate for solution for infusion.
Fabrazyme 35 mg, trab għall- konċentrat għal soluzzjoni għall- infużjoni.
Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta.
Kull kunjett ta ’ Fabrazyme fih valur nominali ta ’ 35 mg ta ’ agalsidase beta.
After reconstitution with 7.2 ml water for injections, each vial of Fabrazyme contains 5 mg/ ml (35 mg/ 7 ml) of agalsidase beta.
Wara r- rikostituzzjoni b’ 7. 2 ml ta ’ ilma għall- injezzjonijiet, kull kunjett ta ’ Fabrazyme ikun fih 5 mg/ ml (35 mg/ 7 ml) ta ’ agalsidase beta.
The reconstituted solution must be diluted further (see section 6.6).
Is- soluzzjoni rikostitwita trid tkun dilwita aktar (ara sezzjoni 6. 6).
Agalsidase beta is a recombinant form of human α -galactosidase A and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture.
Agalsidase beta hi forma rikombinanti ta ’ l- α- galactosidase A umana li hu magħmul mit- teknoloġija tad- DNA rikombinanti mit- trobbijja ta ’ ċelluli mammiferi ta ’ l- Ovarji tal- Ħamster Ċiniż (CHO).
The amino acid sequence of the recombinant form, as well as the nucleotide sequence which encoded it, are identical to the natural form of α -galactosidase.
Is- sekwenza ta ’ l- aċidi aminiċi tal- forma rikombinanti, flimkien mas- sekwenza tan- nukleotidi li tiddeċifrha, huma identiċi għall- forma naturali ta ’ l- α- galactosidase.
Powder for concentrate for solution for infusion White to off-white lyophilized cake or powder
Trab għall- konċentrat għal soluzzjoni għall- infużjoni Kejk jew trab abjad jew off- white lajofilizzat
Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α -galactosidase A deficiency).
Fabrazyme jintuża għal terapija ta ’ sostituzzjoni ta ’ enżimi fuq perijodu ta ’ żmien twil f’ pazjenti li għandhom djanjosi konfermati għal marda Fabry (nuqqas ta ’ α- galactosidase A).
Fabrazyme treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases.
Il- kura b’ Fabrazyme għandha tkun f’ idejn tabib li għandu esperjenza fl- immaniġġjar ta ’ pazjenti li jbatu mill- Marda Fabry jew mard ieħor metaboliku li jintired.
The recommended dose of Fabrazyme is 1mg/ kg body weight administered once every 2 weeks as an intravenous infusion.
Id- doża rakkomandata ta ’ Fabrazyme hi 1 mg/ kg tal- piż tal- ġisem li tingħata darba kull ħmistax bħala infużjoni minn ġol- vina.
For further instructions see section 6.6.
Għal aktar struzzjonijiet ara sezzjoni 6. 6.
Alternative dosing regimens have been used in clinical studies.
Programmi ta ’ dożaġġ alternattiv intużaw fi studji kliniċi.
In one of these studies, after an initial dose of 1.0 mg/ kg every 2 weeks for 6 months, 0.3 mg/ kg every 2 weeks may maintain clearance of GL-3 in certain cell types in some patients; however, the long term clinical relevance of these findings has not been established (see section 5.1).
F’ wieħed minn dawn l- istudji, wara doża inizjali ta ’ 1. 0 mg/ kg kull ġimagħtejn għal 6 xhur, 0. 3 mg/ kg kull ġimagħtejn jistgħu jikkawżaw eliminazzjoni ta ’ GL- 3 f’ ċertu tipi ta ’ ċelloli f’ xi pazjenti; madankollu ir- rilevanza klinika fuq perijodu ta ’ żmien twil ta ’ dawn ir- riżultati għadu ma ġiex stabbilit (ara sezzjoni 5. 1).
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 tal- bidu ta ’ l- infuzjoni m’ għandhiex tkun ta ’ aktar minn 0. 25 mg/ min (15 mg/ kull siegħa) biex tnaqqas r- riskju ta ’ reazzjonijiet relatati ma ’ l- infużjoni.
After patient tolerance is established, the infusion rate may be increased gradually with subsequent infusions.
Wara li tkun stabbilita t- toleranza tal- pazjent, ir- rata ta ’ l- infużjoni għandha mnejn tkun miżjuda bil- mod il- mod bl- infużjonijiet ta ’ wara.
No dose adjustment is necessary for patients with renal insufficiency.
M’ hemm bżonn l- ebda tibdil tad- doża għall- pażjenti li jsofru minn insuffiċjenza tal- kliewi.
Studies in patients with hepatic insufficiency have not been performed.
Ma saru l- ebda studji fuq pazjenti li jsofru minn insuffiċjenza epatika.
The safety and efficacy of Fabrazyme in patients older than 65 years have not been established and no dosage regimen can presently be recommended in these patients.
Is- sigurtà u l- effikaċja ta ’ Fabrazyme f’ pazjenti akbar minn 65 sena ma ġewx stabbiliti u l- ebda reġim tad- doża ma jista ’ jkun rakkomandat fil- preżent għal dawn il- pazjenti.
2 Paediatric patients Studies in children 0-7 years have not been performed and no dosage regimen can presently be recommended in patients in this paediatric age group as safety and efficacy have not yet been established.
2 Pazjenti pedjatriċi Ma sarux studji fuq tfal ta ’ bejn 0- 7 snin u l- ebda programm ta ’ dożi ma jista ’ attwalment jiġi rakkomandat għal pazjenti f’ dan il- grupp ta ’ età pedjatrika peress li s- sgurtà u l- effikaċja għadhom ma ġewx stabbiliti.
No dose adjustment is necessary for children 8-16 years.
4. 3 Kontra- indikazzjonijiet
Life threatening hypersensitivity (anaphylactic reaction) to the active substance or any of the excipients.
Sensittività eċċessiva li tista ’ tikkawża l- mewt (reazzjoni anafilattika) għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi li hemm miegħu.
Since agalsidase beta (r-hα GAL) is a recombinant protein, the development of IgG antibodies is expected in patients with little or no residual enzyme activity.
Peress li agalsidase beta (r- hαGAL) hi proteina rikombinanti, hu mistenni li jiġu żviluppati antikorpi ta ’ l- IgG f’ pazjenti bi ftit jew xejn attività ta ’ l- enżimi residwali.
The majority of patients developed IgG antibodies to r-hα GAL, typically within 3 months of the first infusion with Fabrazyme.
Il- maġġoranza ta ’ pazjenti żviluppaw l- antikorpi IgG għal r- hαGAL, ġeneralment fi żmien 3 xhur mill- ewwel infużjoni b’ Fabrazyme.
Over time, the majority of seropositive patients in clinical trials demonstrated either a downward trend in titers (based on a ≥ 4-fold reduction in titer from the peak measurement to the last measurement) (40% of the patients), tolerised (no detectable antibodies confirmed by 2 consecutive radioimmunoprecipitation (RIP) assays) (14% of the patients) or demonstrated a plateau (35% of the patients).
Maż- żmien, il- biċċa l- kbira ta ’ pazjenti seropożittivi fil- provi kliniċi wrew jew xejra l- isfel fit- titri (fuq bażi ta ’ tnaqqis ta’ ≥ 4 darbiet fit- titru mill- kejl l- aktar għoli sa l- aħħar kejl) (40% tal- pazjenti), ittolerizzaw (l- ebda antikorpi intraċċati kkonfermati permezz ta ’ 2 assaġġi ta ’ radjuimmunopreċipitazzjoni (RIP) konsekuttivi) (14% tal- pazjenti) jew urew livellar (35% tal- pazjenti).
Patients with antibodies to r-hα GAL have a greater potential to experience infusion-associated reactions (IARs), which are defined as any related adverse event occurring on the infusion day.
Pazjenti b’ antikorpi għal r- hαGA għandhom potenzjal ogħla li jkollhom reazzjonijiet assoċjati ma ’ l- infużjoni (IAR), li huma mfissra bħala kull każ avvers relatat li jseħħ fil- jum ta ’ l- infużjoni.
These patients should be treated with caution when re-administering agalsidase beta (See section 4.8).
Dawn il- pazjenti għandhom jiġu trattati b’ kawtela meta jiġu mogħtija agalsidase beta mill- ġdid (ara sezzjoni 4. 8).
Antibody status should be regularly monitored.
L- istat ta ’ l- antikorpi għandu jiġi monitorat regolarment.
In clinical trials, sixty seven percent (67%) of the patients experienced at least one infusion-associated reaction (See section 4.8).
Fil- provi kliniċi, sebgħa u sittin fil- mija (67%) tal- pazjenti kellhom ta ’ l- anqas reazzjoni waħda assoċjata ma ’ l- infużjoni (ara sezzjoni 4. 8).
The frequency of IARs decreased over time.
Il- frekwenza ta ’ l- IAR naqset maż- żmien.
Patients experiencing mild or moderate infusion-associated reactions when treated with agalsidase beta during clinical trials have continued therapy after a reduction in the infusion rate (~0.15 mg/ min; 10 mg/ hr) and/ or pre-treatment with antihistamines, paracetamol, ibuprofen and/ or corticosteroids.
Pazjenti li kellhom reazzjonijiet relatati ma ’ l- infużjoni ħfief jew moderati, meta kienu trattati b’ agalsidase beta waqt provi kliniċi issoktaw bit- terapija wara tnaqqis fir- rata ta ’ l- infużjoni (~0. 15 mg/ min; 10 mg/ siegħa) u/ jew trattament minn qabel b’ antistamini, paracetamol, ibuprofen u/ jew kortikosterojdi.
As with any intravenous protein product, allergic-type hypersensitivity reactions are possible.
Bħal kwalunkwe prodott tal- proteina li jingħata minn ġol- vina, jista ’ jkun hemm reazzjonijiet ta ’ sensittività eċċessiva ta ’ tip allerġiku.
A small number of patients have experienced reactions suggestive of immediate (Type I) hypersensitivity.
Għadd żgħir ta ’ pazjenti kellhom reazzjonijiet suġġestivi ta ’ sensittività eċċessiva immedjata (Tip I).
If severe allergic or anaphylactic-type reactions occur, immediate discontinuation of the administration of Fabrazyme should be considered and appropriate treatment initiated.
Jekk ikun hemm reazzjonijiet qawwija tat- tip allerġiku jew reazzjonijiet qawwija tat- tip anafilattiku, wieħed għandu jara jekk għandux iwwaqqaf immedjatament Fabrazyme u jagħti kura kif jixraq.
The current medical standards for emergency treatment are to be observed.
L- istandards mediċi attwali f’ każ ta ’ emerġenza għandhom ikunu mħarsa.
With careful rechallenge Fabrazyme has been re-administered to all 6 patients who tested positive for IgE antibodies or had a positive skin test to Fabrazyme in a clinical trial.
Bi sfida kawta Fabrazyme ngħata mill- ġdid lil kull wieħed mis- sitt pazjenti li kienu rriżultaw pożittiv għall- antikorpi IgE jew kellhom test pożittiv fuq il- ġilda għal Fabrazyme fi prova klinika.
Once a patient tolerates the infusion, the dose may be increased to reach the therapeutic dose of 1 mg/ kg and the infusion rate may be increased by slowly titrating upwards, as tolerated.
F’ din il- prova, l- għoti inizjali mill- ġdid kien f’ doża baxxa u f’ rata ta ’ infużjoni aktar baxxa (1/ 2 id- doża terpaewtika f’ 1/ 2 5 tar- rata standard rakkomandata) Ladarba pazjent jittolera l- infużjoni, id- doża tista ’ tiżdied biex tilħaq id- doża terapewtika ta ’ 1 mg/ kg u r- rata ta ’ l- infużjoni tista ’ tiżdied b’ titrazzjoni li togħla ftit ftit, skond kif jiġi tollerat.
The effect of Fabrazyme treatment on the kidneys may be limited in patients with advanced renal disease.
L- effett tal- kura b’ Fabrazyme fuq il- kliewi għandu mnejn ikun limitat f’ pazjenti li jsofru minn mard avvanzat tal- kliewi.
Studies have not been conducted to assess the potential effects of Fabrazyme on impairment of fertility.
Ma saru l- ebda studji biex jitqiesu l- effetti ħżiena li jista ’ jkollu Fabrazyme fuq il- fertilità.
4.5 Interaction with other medicinal products and other forms of interaction
3 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
No interaction studies and no in vitro metabolism studies have been performed.
Ma sarux studji dwar l- effett li jista ’ jkun hemm meta jingħataw mediċini oħra u dwar metaboliżmu in vitro.
Based on its metabolism, agalsidase beta is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Meta wieħed iqies il- metaboliżmu tiegħu, mhux probabbli li jista ’ ikun hemm interazzjonijiet permezz taċ- ċitokromju P450 bejn l- agalsidase beta u mediċini oħra.
Fabrazyme should not be administered with chloroquine, amiodarone, benoquin or gentamycin due to a theoretical risk of inhibition of intra-cellular α -galactosidase activity.
Fabrazyme m’ għandux jingħata flimkien ma ’ chloroquine, amiodarone, benoquin jew gentamycin għax hemm il- ħsieb li dawn is- sustanzi jistgħu jimpedixxu l- attività intra- ċellulari ta ’ α- galactosidase.
3 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
There are no adequate data from the use of agalsidase beta in pregnant women.
M’ hemm l- ebda tagħrif xieraq dwar l- użu ta ’ agalsidase beta waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/ foetal development (See section 5.3).
Studji fuq annimali ma jindikawx li hemm effetti diretti jew indiretti li jgħamlu ħsara fl- iżvilupp ta ’ l- embriju/ tal- fetu (ara sezzjoni 5. 3).
Fabrazyme should not be used during pregnancy unless clearly necessary.
Fabrazyme m’ għandux jintuża waqt it- tqala għajr meta jkun jidher ċar li hemm bżonnu.
Agalsidase beta may be excreted in milk.
Agalsidase beta jista ’ jiġi eliminat mal- ħalib tas- sider.
Because there are no data available on effects in neonates exposed to agalsidase beta via breast milk, it is recommended to stop breast-feeding when Fabrazyme is used.
Minħabba li m’ hemmx tagħrif dwar x’ effetti jista ’ jkollhom trabi tat- twelid jekk jingħataw agalsidase beta mill- ħalib tas- sider, huwa rakkomandat li ma jkunx hemm treddigħ waqt it- teħid ta ’ Fabrazyme.
No studies on the ability to drive and use machines have been performed with Fabrazyme.
Ma saru l- ebda studji fuq il- ħila ta ’ sewqan u l- użu ta ’ magni meta persuna tkun qed tuża Fabrazyme.
Adverse drug reactions (ADRs) reported from clinical trials to be related to Fabrazyme administered at a dose of 1mg/ kg in a total of 168 patients (154 males and 14 females) treated with Fabrazyme for a minimum of one infusion up to a maximum of 5 years are listed by System Organ Class and frequency (very common ≥ 1/ 10; common ≥ 1/ 100 to < 1/ 10 and uncommon ≥ 1/ 1000 to < 1/ 100) in the table below.
Reazzjonijiet avversi tal- mediċina (ADRs) rapportati minn provi kliniċi li kienu relatati ma ’ Fabrazyme mogħti f’ doża ta ’ 1mg/ kg fuq total ta ’ 168 pazjent (154 raġel u 14- il mara) ittrattati b’ Fabrazyne għal minimu ta ’ infużjoni waħda sa massimu ta ’ 5 snin huma elenkati skond is- Sistema tal- Klassifika ta ’ l- Organi u frekwenza (komuni ħafna ≥1/ 10; komuni ≥ 1/ 100 sa < 1/ 10 u mhux komuni ≥1/ 1000 sa < 1/ 100) fit- tabella t’ hawn taħt.
The occurrence of an ADR in a single patient is defined as uncommon in light of the relatively small number of patients treated.
L- okkorrenza ta’ ADR f’ xi pazjent hi mfissra bħala mhix komuni fid- dawl ta ’ l- għadd relativament żgħir ta ’ pazjenti trattati.
ADRs only reported during the Post Marketing period are also included in the table below at a frequency category of “ unknown”.
ADRs li ġew rapportati biss waqt il- perijodu ta ’ Wara t- Tqegħid fis- Suq ġew inklużi wkoll fit- tabella t’ hawn isfel fil- kategorija ta ’ frekwenzi ta ’ “ mhux magħrufa ”.
ADRs were mostly mild to moderate in severity:
L- ADRs kienu fil- maġġoranza tagħhom ħfief jew moderati fil- qawwa tagħhom.
Incidence of Related Adverse Events with Fabrazyme Treatment
4 Inċidenza ta ’ Kazijiet Avversi Relatati * bi Trattament b’ Fabrazyme
Very
Komuni
Uncommon
komuni
Frequency
Frekwenza mhix
Class Infections and infestations
tal- Klassifika ta ’ l- Organi
common
ħafna
nasopharyngitis
magħrufa
rhinitis
nasofarinġite
unknown
rinite
Immune system disorders
fis- sistema immuni
anaphylactoid reaction
reazzjoni anafilattojdi
Nervous system disorders
iperestesja, rogħda sturdament, ħedla, Disturbi fis -
Headache, paraesthesia
sistema nervuża
dizziness, somnolence, hypoaesthesia, burning sensation, lethargy, syncope
ras, paraestesija
hyperaesthesia, tremor
sensazzjoni ta ’ ħruq, letarġija, sinkope.
lacrimation increased
żieda fid- dmugħ
eye pruritus, ocular hyperaemia
ħakk fl- għajnejn, iperemja okulari
tinnitus, vertigo
tinnite, vertiġini
auricular swelling, ear pain
nefħa awrikulari, uġigħ fil- widnejn
Cardiac Disorders
Disturbi fil- qalb
tachycardia, palpitations, bradycardia
takikardja, bradikardja, palpitazzjonijiet fwawar, pressjoni
sinus bradycardia
sinus bradikarja kesħa periferali
System Organ
Disturbi vaskulari
Common
għolja, sfurija, pressjoni baxxa, fwawar sħan dispnea,
Frequency
bronkospażmu,
Vascular disorders
Disturbi respiratorji,
flushing, hypertension, pallor, hypotension, hot flush
konġestjoni
peripheral coldness
uġigħ
Respiratory, thoracic and mediastinal disorders
faringolarinġejali, fl- imnieħer, toraċiċi u rinorreja, griżmejn issikkati, medjastinali takipneja, tħarħir, sogħla, konġestjoni dispnea mħarxa fl- apparat respiratorju ta ’ fuq dispepsja, disfaġja Disturbi
---
dardir,
dyspnoea, nasal congestion, throat tightness, wheezing, cough, dyspnoea exacerbated
uġigħ addominali,
Gastrointestinal Disorders
gastro- intestinali
nausea, vomiting
remettar
abdominal pain, abdominal pain upper, abdominal discomfort, stomach discomfort, hypoaesthesia oral, diarrhoea
uġigħ addominali n- naħa ta ’ fuq, skonfort addominali, skumdita fl - istonku, ipoestesija orali, dijarea ħakk, urtikarja,
---
vaskulite
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’
pruritus, urticaria, rash, erythema, pruritus generalized, angioneurotic oedema, swelling face, rash maculo- papular
raxx, eritema, ħakk ġeneralizzat,
livedo reticularis, rash erythematous, rash pruritic, skin discolouration, skin discomfort
raxx eritematosi, ħakk tar- raxx,
leukocytoclastic vasculitis
lewkoċitoklastika
Musculoskeletal and connective tissue disorders
tibdil tal- kulur tal - edema taħt il- ġilda ġilda, skonfort fuq anġjonewrotika, il- ġilda. wiċċ minfuħ, raxx makulo- papulari uġigħ uġigħ Disturbi muskolu - skeletriċi u
pain in extremity, myalgia, back pain, muscle spasms, arthralgia, muscle tightness, musculoskeletal stiffness
fl- estremitajiet, uġigħ fl- għadam,
musculoskeletal pain
muskoluskeletrku
General disorders and
5 tat- tessut konnettiv
chills, pyrexia,
sirdat, deni,
fatigue, chest discomfort, feeling
uġigħ fid- dahar, spażmi muskolari, artralġja, tagħfis fil- muskoli, ebusija muskolu- skeletriku għeja, skonfort
feeling hot and cold, influenza-like
tħoss is- sħana u
illness, infusion site pain, infusion site reaction, injection site thrombosis, malaise, oedema
l- bard, mard bħal fis- sider, tħoss tħoss il - ġenerali u ta ’ l- influwenza, is- sħana, edema bard kondizzjonijiet uġigħ fis- sit ta ’ periferali, uġigħ, ta 'mnejn l- infużjoni, astenja, uġigħ jingħata trombożi fis- sit ta ’ fis- sider, edema l- injezzjoni, tal- wiċċ, ipertemja tħossok ma tiflaħx, edema Għall- iskop ta ’ din it- tabella, ≥1% hu mfisser bħala każ li seħħ f’ 2 pazjenti jew aktar.