qanastek/EMEA-V3 huggingface dataset:
4 Musculoskeletal, connective tissue and bone disorders
Mard muskolu- skeltrali u tal- connective tissue
musculoskeletal discomfort, myalgia, back pain, limb pain, peripheral swelling, arthralgia, joint swelling
skumdità muskolu- skeletrika, uġigħ fil- muskoli, uġigħ fid- dahar, uġigħ fir- riġlejn jew fid- driegħ, nefħa periferika, artralġja, nefħa fil- ġogi
sensation of heaviness
sensazzjoni ta 'toqol
General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata tertir, deni, uġigħ u skumdità, għejja Komuni ħafna:
rigors pyrexia, pain and discomfort, fatigue fatigue aggravated, feeling hot, feeling cold, asthenia, chest pain, chest tightness, influenza like illness, injection site rash, malaise
għejja aggravata, tħossok sħun, tħossok kiesaħ, astenja, uġigħ fis- sider, sider issikkat, mard bħal ta 'l- influwenza, raxx mis- sit ta' l- influwenza, telqa
corneal reflex decreased oxygen saturation decreased
tnaqqis fir- rifless korneali tnaqqis fis- saturazzjoni ta 'l- ossiġenu
Adverse drug reactions reported in patients with history of end stage renal disease were similar to those reported in the general patient population.
Reazzjonijiet avversi għal mediċina kienu rrapportati f’ pazjenti bi storja ta ’ mard renali fl- istadju finali li kienu simili għal dawk irrapportati fil- popolazzjoni tal- pazjenti ġenerali.
Adverse drug reactions reported in the paediatric population (children and adolescents) were, in general, similar to those reported in adults.
Reazzjonijiet avversi tal- mediċina fil- popolazzjoni pedjatrika (tfal u adolexxenti) kienu, b' mod ġenerali, simili għal dawk irrapportati fl- adulti.
However, infusion related reactions and pain exacerbation occurred more frequently.
Madankollu, reazzjonijiet relatati ma ’ l- infuzzjoni u uġigħ eħrex seħħew aktar ta ’ spiss.
The most frequent were mild infusion-related reactions that mainly included rigors, pyrexia, flushing, headache, nausea, and dyspnoea.
L- aktar reazzjonijiet ħfief frekwentament irrapportati kienu relatati ma ’ l- infużjoni li fil- parti l- kbira kienu jinkludu tertir, deni, fwawar, uġigħ ta ’ ras, dardir, u qtugħ ta ’ nifs.
Other alimentary tract and metabolism products - Enzymes.
Prodotti tal- passaġġ alimentari u tal- metaboliżmu oħrajn - Enżimi.
Fabry Disease is a glycosphingolipid storage disorder that is caused by deficient activity of the lysosomal enzyme α -galactosidase A, resulting in accumulation of globotriaosylceramide (also referred to as Gb3 or CTH), the glycosphingolipid substrate for this enzyme.
Il- Marda Fabry hija disturb li taffettwa l- ħażna ta ’ glycosphingolipid kkaġunata minn attività defiċjenti ta ’ l- enżima liżosomali α- galactosidase A, li tirriżulta f’ akkumulazzjoni ta ’ globotriaosylceramide (magħruf ukoll bħala Gb3 jew CTH), is- substrat ta ’ glycosphingolipid għal din l- enżima.
Agalsidase alfa catalyses the hydrolysis of Gb3, cleaving a terminal galactose residue from the molecule.
Agalsidase alpha jikkatalizza l- idroliżi ta ’ Gb3, billi jofroq residwu terminali ta ’ galaktosju mill- molekula.
Treatment with the enzyme has been shown to reduce accumulation of Gb3 in many cell types including endothelial and parenchymal cells.
Trattament bl- enżima ġie muri li jnaqqas l- akkumulazzjoni ta ’ Gb3 f’ ħafna tipi ta ’ ċelloli inklużi ċelloli endoteljali u parenkemali.
Agalsidase alfa has been produced in a human cell line to provide for a human glycosylation profile that can influence uptake by mannose-6-phosphate receptors on the surface of target cells.
Agalsidase alfa ġie magħmul f’ razza ta ’ ċelloli umani biex jipprovdi għal profil ta ’ glajkosilizzazzjoni umana li tista ’ tinfluwenza t- teħid minn riċettaturi mannose- 6- phoshate fil- wiċċ taċ- ċelloli bersalljati.
The safety and efficacy of Replagal was assessed in two randomised, double blind, placebo controlled studies and open label extension studies, in a total of forty patients with a diagnosis of Fabry Disease based on clinical and biochemical evidence.
Is- sigurtà u l- effikaċja ta ’ Replagal kien assaġġjat f’ żewġ studji randomizzati, double blind, ikkontrollati bi plaċebo u bi studji ta ’ estensjoni b’ tikketta miftuħa, f’ total ta ’ erbgħin pazjent bid - dijanjożi tal- Marda Fabry ibbażati fuq evidenza klinika u bijokemikali.
Patients received the recommended dosage of 0.2 mg/ kg of Replagal.
Pazjenti ngħataw id- doża rakkomandata ta ’ 0. 2 mg/ kg ta ’ Replagal.
Twenty-five patients completed the first study and entered an extension study.
Ħamsa u għoxrin pazjent komplew l- ewwel studju u daħlu fi 5 studju aktar estensiv.
After 6 months of therapy there was a significant reduction in pain in the Replagal treated patients compared with placebo (p=0.021), as measured by the Brief Pain Inventory (a validated pain measurement scale).
Wara 6 xhur ta ’ terapija kien hemm tnaqqis sinifikanti fl- uġigħ fil- pazjenti trattati b’ Replagal meta mqabbel ma ’ plaċebo (p=0. 021), kif imkejjel permezz ta ’ l- Inventarju ta ’ Uġigħ Brev (skala ta ’ kejl ta ’ l- uġigħ validata).
This was associated with a significant reduction in chronic neuropathic pain medication use and number of days on pain medication.
Dan kien assoċjat ma ’ tnaqqis sinifikanti fl- użu ta ’ mediċini għall- uġigħ newropatiku kroniku u fl- għadd ta ’ jiem fuq il- mediċina.
In subsequent studies, in male paediatric patients, a reduction in pain was observed after 9 and 12 months of Replagal therapy compared to pre-treatment baseline.
Fi studji sussegwenti, f’ pazjenti pedjatriċi subien, tnaqqis fl- uġigħ kien osservat wara 9 sa 12- il xahar ta ’ terapija b’ Replagal ikkomparat fil- linja bażi ta ’ riferiment ma ’ trattament ta ’ qabel.
5 Twelve to 18 months of treatment with Replagal resulted in improvement in quality of life (QoL), as measured by validated instruments.
Trattament b’ Replagal għal bejn tnax sa 18- il xahar irriżulta f’ titjib fil- kwalità tal- ħajja (QoL), kif imkejjel bi strumenti validati.
After 6 months of therapy Replagal stabilised renal function compared with a decline in placebo treated patients.
Wara terapija ta ’ 6 xhur Replagal stabbilizza l- funzjoni renali kkomparat ma ’ tnaqqis f’ pazjenti trattati bi plaċebo.
Kidney biopsy specimens revealed a significant increase in the fraction of normal glomeruli and a significant decrease in the fraction of glomeruli with mesangial widening in patients treated with Replagal in contrast to the patients treated with placebo.
Kampjuni ta ’ bijopsiji mill- kliewi żvelaw żjieda sinifikattiva fil- frazzjoni ta ’ glomeruli normali u tnaqqis sinifikattiv fil- frazzjoni ta ’ glomeruli bi twessigħ meżanġjali f’ pazjenti ttrattati b’ Replagal b’ kuntrast ma ’ pazjenti ttrattati bi plaċebo.
After 12 to 18 months of maintenance therapy, Replagal improved renal function as measured by inulin based glomerular filtration rate by 8.7 ± 3.7 ml/ min.
Wara 12 sa 18- il xahar ta ’ terapija ta ’ manteniment, Replagal tejjeb il- funzjoni renali kif imkejla b’ rata ta ’ filtrazzjoni glomerulari bbażata fuq inulin bi 8. 7 ± 3. 7 ml/ min (p=0. 030).
(p=0.030).
(p=0. 030).
Longer term therapy (48-54 months) resulted in stabilisation of GFR in male patients with normal baseline GFR (≥ 90 mL/ min/ 1.73 m2) and with mild to moderate renal dysfunction (GFR 60 to < 90 mL/ min/ 1.73 m2), and in slowing of the rate of decline in renal function and progression to end-stage renal disease in male Fabry patients with more severe renal dysfunction (GFR 30 to < 60 mL/ min/ 1.73 m2).
Terapija ta ’ perijodu ta ’ żmien itwal (48- 54 xahar) irriżultat fi stabbilizzazzjoni ta ’ GFR f’ pazjenti rġiel bi GFR normali fil- linja bażi ta ’ riferiment (≥ 90 mL/ min/ 1. 73 m2) u b’ funzjoni ħazina renali minn ħafifa għal moderata (GFR 60 sa < 90 mL/ min/ 1. 73 m2), u b’ dewmien tar- rata ta ’ tnaqqis fil- funzjoni renali u l- progressjoni għal mard renali fl- istadju finali f’ pazjenti Fabry irġiel b’ funzjoni renali ħażina aktar severa (GFR 30 sa < 60 mL/ min/ 1. 73 m2).
In male paediatric Fabry patients, hyperfiltration can be the earliest manifestation of renal involvement in the disease.
F’ pazjenti pedjatriċi maskili bil- marda Fabry, iperfiltrazzjoni tista ’ tkun l- aktar manifestazzjoni bikrija ta ’ involviment renali fil- marda.
Reduction in their hypernormal eGFRs was observed within 6 months of initiating Replagal therapy.
Tnaqqis fl- eGFRs ipernormali tagħhom kien osservat fi żmien 6 xhur mill- bidu ta ’ terapija b’ Replagal.
In a second study, fifteen patients with left ventricular hypertrophy completed a 6 month placebo- controlled study and entered an extension study.
Fit- tieni studju, ħmistax- il pazjent b’ ipertrofija ventrikulari tax- xellug temmew studju kontrollat bi plaċebo ta ’ 6 xhur u daħlu fi studju ta ’ estensjoni.
Treatment with Replagal resulted in an 11.5 g decrease in left ventricular mass as measured by magnetic resonance imaging (MRI) in the controlled study, while patients receiving placebo exhibited an increase in left ventricular mass of 21.8 g.
Trattament b’ Replagal irriżulta fi tnaqqis ta ’ 11. 5 g fil- massa ventrikulari tax- xellug kif imkejla bl- immaġini ta 'resonanza manjetika (MRI) fl- istħarriġ ikkontrollat, waqt li pazjenti li kienu qegħdin jingħataw plaċebo wrew żieda fil- massa ventrikulari tax - xellug ta ’ 21. 8 g.
In addition, in the first study involving 25 patients, Replagal effected a significant reduction in cardiac mass after 12 to 18 months of maintenance therapy (p < 0.001).
Barraminhekk, fl- ewwel studju li kien jinvolvi 25 pazjent, Replagal kellu effett sinifikanti fit- tnaqqis tal- massa kardijaka wara 12 sa 18- il xahar ta ’ terapija ta ’ manteniment (p < 0. 001).
Replagal was also associated with improved myocardial contractility, a decrease in mean QRS duration and a concomitant decrease in septal thickness on echocardiography.
Replagal kien ukoll assoċjat ma ’ titjib fil- kontratilità mijokardjali, tnaqqis fid- dewmien QRS medju u tnaqqis konkomitanti tal- ħxuna septali fuq l- ekokardjografija.
Two patients with right bundle branch block in the studies conducted reverted to normal following therapy with Replagal.
Fl- istudji magħmulin żewġ pazjenti b’ right bundle branch block reġgħu lura għan- normal wara terapija b’ Replagal.
Subsequent open label studies demonstrated significant reduction from baseline in left ventricular mass by echocardiography in both male and female Fabry patients over 24 to 36 months of Replagal treatment.
Studji sussegwenti bit- tikketta tidher urew tnaqqis sinifikattiv mil- linja bażi ta 'riferiment fil- massa ventrikulari tax- xellug kemm f’ pazjenti Fabry irġiel u kemm nisa fuq trattament ta ’ 24 sa 36 xhar b’ Replagal.
The reductions in LV mass observed by echocardiography in both male and female Fabry patients over 24 to 36 months of Replagal treatment were associated with meaningful symptom improvement as measured using the NYHA and CCS in Fabry patients with severe heart failure or anginal symptoms at baseline.
It- tnaqqis fil- massa LV osservata permezz ta ’ l- ekokardjografija kemm f’ pazjenti Fabry irġiel u kemm nisa fuq trattament ta ’ 24 sa 36 xhar b’ Replagal kien assocjat ma’ titjib sinifikanti fis - sintomi kif imkejjel bil- NHYA u CCS f’ pazjenti Fabry b’ falliment tal- qalb severu jew sintomi anġinali fil- linja bażi ta 'riferiment.
Compared with placebo, treatment with Replagal also reduced accumulation of Gb3.
Ikkomparat ma ’ plaċebo, trattament b’ Replagal naqqas ukoll l- akkumulazzjoni ta ’ Gb3.
After the first 6 months of therapy mean decreases of approximately 20 - 50% were observed in plasma, urine sediment and liver, kidney and heart biopsy samples.
Wara l- ewwel 6 xhur ta ’ terapija tnaqqis medju ta ’ madwar 20- 50% kienu osservati fil- plażma, fis- sediment ta ’ l- awrina u fil- kampjuni ta ’ bijopsiji tal- fwied, tal- kliewi u tal- qalb.
After 12 to 18 months treatment a reduction of 50 – 80% was observed in plasma and urine sediment.
Wara trattament ta ’ bejn 12 sa 18- il xahar tnaqqis ta ’ 50- 80% kien osservat fil- plażma u fis- sediment ta ’ l- awrina.
The metabolic effects were also associated with clinically significant weight gain, increased sweating and increased energy.
L- effetti metaboliċi kienu assoċjati wkoll ma ’ żieda fil- piż klinikament sinifikanti, żieda fil- ħruġ ta ’ l- għaraq u żieda fl - enerġija.
Consistent with the clinical effects of Replagal, treatment with the enzyme reduced accumulation of Gb3 in many cell types, including renal glomerular and tubular epithelial cells, renal capillary endothelial cells (cardiac and dermal capillary endothelial cells were not examined) and cardiac myocytes.
Konsistenti ma ’ l- effetti kliniċi ta ’ Replagal, trattament bl- enżima naqqas l- akkumulazzjoni ta ’ Gb3 f’ ħafna tipi ta ’ ċelloli, inklużi ċelloli renali glomerulari u tubulari epiteljali, ċelloli renali endoteljali kapillarji (ċelloli endoteljali kappilarji kardjaċi u dermali ma kinux eżaminati) u majoċiti kardijaċi.
In male paediatric Fabry patients plasma Gb3 decreased 40-50% after 6 months of Replagal therapy and this reduction persisted after a total of 12 months of treatment.
F’ pazjenti pedjatriċi subien bil- Fabry il- Gb3 fil- plażma naqas b’ 40- 50% wara 6 xhur ta ’ terapija b’ Replagal u dan it- tnaqqis ippersista wara total ta ’ 12- il xahar ta ’ trattament.
Antibodies to agalsidase alfa have not been shown to be associated with any clinically significant effects on safety (e. g. infusion reactions) or efficacy.
Antikorpi għal agalsidase alfa ma ntwerewx li huma assoċjati ma 'effetti klinikament sinifikanti dwar is- sigurtà (eż. reazzjonijiet ta' infużjoni) jew effikaċja.
Infusion of Replagal at home may be considered for patients who are tolerating their infusions well.
6 Tista ’ tiġi kkunsidrata infuzjoni ta ’ Replagal id- dar għal pazjenti li qegħdin jittolleraw l- infuzjonijiet tagħhom sewwa.
This medicinal product has been authorised under “ Exceptional Circumstances”.
Dan il- prodott mediċinali kien awtorizzat taħt “ Ċirkustanzi ta 'Eċċezzjoni ”.
This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
Dan ifisser li minħabba li l- marda li qed tbati minnha hija rari ma kienx possibbli li tinkiseb informazzjoni kompleta dwar il- benefiċċji u r- riskji ta 'dan il- prodott mediċinali.
6 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Single doses ranging from 0.007 - 0.2 mg enzyme per kg body weight were administered to adult male patients as 20 - 40 minute intravenous infusions while female patients received 0.2 mg enzyme per kg body weight as 40 minute infusions.
Dożi waħdanin li jvarjaw minn 0. 007 - 0. 2 mg enżima għal kull kg ta ’ piż korporali kienu mogħtija lil pazjenti adulti rġiel bħala infużjonijiet intravenużi ta ’ 20- 40 minuta waqt li pazjenti nisa ngħataw 0. 2 mg enżima għal kull kg piż korporali bħala infużjonijiet ta ’ 40 minuta.
The pharmacokinetic properties were essentially unaffected by the dose of the enzyme.
Il- karatteristiċi farmakokinetiċi kienu essenzjalment mhux effettwati bid- doża ta ’ l- enżima.
Following a single intravenous dose of 0.2 mg/ kg, agalsidase alfa had a biphasic distribution and elimination profile from the circulation.
Wara doża waħda intravenuża ta ’ 0. 2 mg/ kg, agalsidase alfa kellu distribuzzjoni u profil ta ’ eliminazzjoni miċ- ċirkulazzjoni bifażiku.
Pharmacokinetic parameters were not significantly different between male and female patients.
Parametri farmakokinetiċi ma kinux sinifikattivament differenti bejn pazjenti nisa u rġiel.
Elimination half-lives were 108 ± 17 minutes in males compared to 89 ± 28 minutes in females and volume of distribution was approximately 17% body weight in both sexes.
Half- lives ta ’ eliminazzjoni kienu 108 ±17- il minuta fl- irġiel kkomparati ma ’ 89 ± 28 minuta fin- nisa u l- volum ta ’ distribuzzjoni kien bejn wieħed u ieħor fi 17% tal- piż korporali fiż - żewġ sessi.
Clearance normalised for body weight was 2.66 and 2.10 ml/ min/ kg for males and females, respectively.
Ir- rata ta 'eliminazzjoni nnormalizzat għal piż korporali kienet ta ’ 2. 66 u 2. 10 ml/ min/ kg għall- irġiel u għan- nisa, rispettivament.
Based on the similarity of pharmacokinetic properties of agalsidase alfa in both males and females, tissue distribution in major tissues and organs is also expected to be comparable in male and female patients.
Ibbażat fuq ix- xebħ ta ’ karatteristiċi farmakokinetiċi ta ’ agalsidase alfa kemm fl- irġiel u kemm fin- nisa, distribuzzjoni fit- tessut fl- organi u fit- tessuti maġġuri hija wkoll mistennija li tkun komparabbli f’ pazjenti rġiel u nisa.
In children (aged 7-18 years), Replagal administered at 0.2 mg/ kg was cleared faster from the circulation than in adults.
Fit- tfal (etajiet bejn 7- 18- il sena), Replagal mogħti f’ 0. 2 mg/ kg kien eliminat aktar malajr miċ- ċirkulazzjoni milli fl- adulti.
Mean clearance of Replagal in children aged (7-11 years), in adolescents (aged 12-18 years), and adults was 4.2 ml/ min/ kg, 3.1 ml/ min/ kg, and 2.3 ml/ min/ kg, respectively.
Ir- rata ta 'eliminazzjoni medja ta ’ Replagal fit- tfal (etajiet bejn 7- 11- il sena), fl- adolexxenti (etajiet 12- 18- il sena), u fl- adulti kienet 4. 2 ml/ min/ kg, 3. 1 ml/ min/ kg, u 2. 3 ml/ min/ kg, rispettivament.
Pharmacodynamic data suggest that at a dose of 0.2 mg/ kg Replagal, the reductions in plasma Gb3 are more or less comparable between adolescents and young children (see section 5.1).
Dejta farmakodinamika ssuġġeriet li f’ doża ta ’ 0. 2 mg/ kg Replagal, it- tnaqqis f’ Gb3 fil- plażma huma ftit jew xejn komparabbli bejn l- adolexxenti u t- tfal żgħar (ara sezzjoni 5. 1).
Following six months of Replagal treatment 12 of 28 male patients showed altered pharmacokinetics including an apparent increase in clearance.
Wara trattament ta ’ sitt xhur b’ Replagal 12 minn 28 pazjent rġiel urew farmakokinetiċi mibdula li inkludew żieda fid- deher fir- rata ta 'eliminazzjoni.
These changes were associated with the development of low titre antibodies to agalsidase alfa but no clinically significant effects on safety or efficacy were observed in the patients studied.
Dawn il- bidliet kienu assoċjati ma ’ l- iżvilupp ta ’ antikorpi kontra agalidase alfa f’ titru baxx iżda l- ebda effetti klinikament sinifikanti fuq sigurtà jew effikaċja ma kienu osservati fil- pazjenti mistħarrġa.
Based on the analysis of pre- and post-dose liver biopsies in males with Fabry Disease, the tissue half- life has been estimated to be in excess of 24 hours and hepatic uptake of the enzyme estimated to be 10% of administered dose.
Ibbażat fuq l- analiżi ta ’ bijopsiji mill- fwied qabel u wara d- doża f’ irġiel bil- Marda Fabry, il- half- life fit- tessut ġiet stmata li hija f’ eċċess ta ’ 24 siegħa u t- teħid epatiku ta ’ l- enżima huwa stmat li huwa ta ’ 10% tad- doża mogħtija.
Agalsidase alfa is a protein and is therefore:
Agalsidase alfa huwa proteina u għaldaqstant:
1) not expected to bind to proteins, 2) expected that metabolic degradation will follow the pathways of other proteins, i. e. peptide hydrolysis, 3) unlikely to be a candidate for drug-drug interactions.
1) mhux mistenni li jintrabat ma ’ proteini, 2) mistenni li degradazzjoni metabolika timxi fil- mogħdijiet ta ’ proteini oħra, i. e. idroliżi tal- peptide, 3) mhux kandidat probabbli għal effetti bejn mediċina u oħra.
Renal elimination of agalsidase alfa is considered to be a minor clearance pathway since pharmacokinetic parameters are not altered by impaired renal function.
L- eliminazzjoni renali ta ’ agalsidase alfa hija kunsidrata li hija mogħdija ta ’ eliminazzjoni minuri għaliex parametri farmakokinetiċi mhumiex mibdula minn funzjoni renali imxekkla.
As metabolism is expected to occur by peptide hydrolysis, impaired liver function is not expected to affect the pharmacokinetics of agalsidase alfa in a clinically significant manner.
Minħabba li l- metaboliżmu huwa mistenni li jseħħ permezz ta ’ idroliżi tal- peptide, funzjoni epatika imxekkla mhix mistennija li teffettwa l- farmakokinetiċi ta ’ agalsidase alfa f’ manjiera klinikament sinifikattiva.
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity.
Informazzjoni mhux klinika ma turi l- ebda periklu speċjali għall- bniedem fuq il- bażi ta 'studji ta' tossiċità ta 'doża ripetuta.
Genotoxic and carcinogenic potential are not expected.
Potenzjali ġenotossiċi u karċinoġenetiċi mhumiex mistennija.
Reproduction toxicity studies in female rats and rabbits have shown no effect on pregnancy or the developing foetus.
Studji dwar it- tossiċità riproduttiva fil- firien u l- fniek nisa ma wrew l- ebda effett fuq it- tqala jew il- fetu li jkun qiegħed jiżviluppa.
No studies have been conducted with respect to parturition or peri/ post-natal development.
L- ebda studju ma ġie magħmul b’ rispett għal ħlas u l- iżvilupp ta ’ madwar/ ta ’ wara t- twelid.
It is not known whether Replagal crosses the placenta.
Mhux magħruf jekk Replagal jaqsamx is- sekonda.
Sodium phosphate monobasic, monohydrate Polysorbate 20 Sodium chloride Sodium hydroxide Water for injections
Sodium phosphate monobasic, monohydrate Polysorbate 20 Sodium chloride Sodium hydroxide Ilma għall- injezzjonijiet
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
2 years Chemical and physical in use stability has been demonstrated for 24 hours at 25°C.
L- istabbilità kimika u fiżika waqt l- użu ġiet murija għal 24 siegħa f' temperatura ta '25°C.
From a microbiological point of view, the product should be used immediately.
Minn aspett mikrobijoloġiku, il- prodott għandu jintuża immedjatament wara r- rikostituzzjoni.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, iż- żminijiet u l- kondizzjonijiet effettivi ta 'ħażna qabel l- użu ġeneralment ma jkunux itwal minn 24 siegħa f' temperatura ta' 2- 8°C (friġġ), sakemm ir- rikostituzzjoni ma tkunx saret f' kondizzjonijiet asettiċi kkontrollati u validati.
1 ml of concentrate for solution for infusion in a 3 ml vial (Type I glass) with a stopper (fluoro-resin coated butyl rubber), a one piece seal (aluminium) and flip-off cap.
1 ml ta 'konċentrat għal soluzzjoni għall- infużjoni f' kunjett ta' 3 ml (ħġieġ ta 'Tip I) b' tapp (lastku butyl ta' reżina tal- fluworo), siġġill ta 'parti waħda (aluminju) u għatu li jinqala bis- saba'.
Pack sizes of 1, 4 or 10 vials.
Daqsijiet tal - pakkett ta '1, 4 jew 10 kunjetti.
3.5 ml of concentrate for solution for infusion in a 5 ml vial (Type I glass) with a stopper (fluoro-resin coated butyl rubber), a one piece seal (aluminium) and flip-off cap.
3. 5 ml ta 'konċentrat għal soluzzjoni għall- infużjoni f' kunjett ta' 5 ml (ħġieġ ta 'Tip I) b' tapp (lastku butyl ta' reżina tal- fluworo), siġġill ta 'parti waħda (aluminju) u għatu li jinqala bis- saba'.
Pack sizes of 1, 4 or 10 vials.
Daqsijiet tal- pakkett ta '1, 4 jew 10 kunjetti.
• Calculate the dose and number of Replagal vials needed.
• Ikkalkula d- doża u l- għadd ta 'kunjetti ta' Replagal meħtieġa.
• Dilute the total volume of Replagal concentrate required in 100 ml of 9 mg/ ml (0.9%) sodium chloride solution for infusion.
• Iddilwa l- volum totali tal- konċentrat ta 'Replagal meħtieġ f' 100 ml ta' 9 mg/ ml (0. 9%) soluzzjoni ta 'sodium chloride għall- infużjoni.
Care must be taken to ensure the sterility of the prepared solutions since Replagal does not contain any preservative or bacteriostatic agent; aseptic technique must be observed.
Attenzjoni għandha tingħata biex tiżgura l - isterilità tas- soluzzjonijiet ippreparati peress li Replagal ma fihx priservattivi jew aġent batterjoloġiku; għandha tiġi osservata teknika asettika.
Once diluted, the solution should be mixed gently but not shaken.
Ġaladarba jkun dilwit, is- soluzzjoni għandha titħallat bil- mod u mhux tiġi mheżżha.
• The solution should be inspected visually for particulate matter and discolouration prior to administration.
• Qabel l- għoti, is- soluzzjoni għandha tiġi spezzjonata viżwalment għal frak u tibdil fil- kulur.
• Administer the infusion solution over a period of 40 minutes using an intravenous line with an integral filter.
8 • Agħti s- soluzzjoni ta 'l- infużjoni ġol- vina permezz ta' pajp li għandu filter integrat fuq perijodu ta '40 minuta.
Since no preservative is present, it is recommended that administration is started as soon as possible and within 3 hours of dilution.
Peress li ma fihx l- ebda priservattiv, huwa rakkomandat li l- għoti jinbeda kemm jista 'jkun malajr u fi żmien 3 sigħat mid- dilwazzjoni.
• Do not infuse Replagal concomitantly in the same intravenous line with other agents.
• M' għandekx tinfuża Replagal ġol- vina fl- istess pajp ma 'mediċini oħrajn.
• For single use only.
• Biex jintuża darba biss.
Shire Human Genetic Therapies AB, Svärdvägen 11 D, 182 33 Danderyd, Sweden Tel: +46 8 5449 6400 Fax: +46 8 5449 6429
Shire Human Genetic Therapies AB, Svärdvägen 11 D, 182 33 Danderyd, L- Iżvezja Tel: +46 8 5449 6400 Faks: +46 8 5449 6429
03/ 08/ 2001 Date of last renewal:
03/ 08/ 2001 Data ta 'l- aħħar tiġdid:
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il- mediċini (EMEA) http: // www. emea. europa. eu /.
Summary of Product Characteristics, 4.2)
Sommarju tal- Karatteristiċi tal- Prodott, sezzjoni 4. 2).
PSURs should be submitted yearly at the time of the annual reassessment.
PSURs għandhom jiġi sottomessi kull sena fiż- żmien ta 'eżami mill- ġdid ta' kull sena.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Sid l- Awtorizzazzjoni tal- Kummerċ għandu jtemm il- programm ta 'studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta' dawn l- istudji għandhom iservu ta 'bażi għall- istima tal- profil bejn is- siwi/ riskju li ssir kull sena.
Five Year Clinical Outcome Study A study in an adequate number of male and female patients to evaluate the effects of long term agalsidase alfa therapy on the frequency of clinical events, such as those that arise as a result of cerebrovascular and cardiovascular pathology, or renal impairment to be undertaken.
Eżitu ta 'Studju Kliniku ta' Ħames Snin Studju fuq għadd adegwat ta 'pazjenti rġiel u nisa biex jiġu evalwati l- effetti fuq terminu ta' żmien twil ta 'terapija ta' agalsidase alfa dwar il- frekwenza ta 'każijiet kliniċi, bħal dawk li jirriżultaw minn eżitu ta' patoloġija ċerebrovaskulari u kardjovaskulari, jew indeboliment renali li jrid jittieħed.
Within this population special emphasis will be put on assessment of progression, including reversibility, of organ dysfunction.
Fi ħdan din il- popolazzjoni enfasi speċjali ser tingħata fuq il- progress, inkluż ir- riversabilità, ta 'organi li jiffunzjonaw ħażin.
Data from historical controls will be collected for comparison.
Ser tinġabar dejta minn kontrolli storiċi għat- tqabbil.
Alternative Dosing Study Evaluation of alternative initial dosing schedules to be undertaken.
Studju ta 'Dożaġġ Alternattiv Għandu jkun hemm evalwazzjoni ta' l- iskedi inizjali alternattivi tad- dożi.
The final report will be submitted upon completion.
Rapport finali għandu jiġi sottomess malli jitlesta.
Maintenance Dosing Study
Studju Dwar il- Manteniment tad- Dożaġġ
11 Evaluation of maintenance dosing schedules and monitoring methods to be undertaken following completion of 5 year outcome evaluation.
11 Evalwazzjoni ta 'l- iskedi tad- dożi ta' manteniment u metodi ta 'monitoraġġ li jridu jsiru mat- tlestija ta' l- eżitu ta 'evalwazzjoni ta' 5 snin.
Study in Children:
Studju fi Tfal:
Additional pharmacokinetic analyses from a paediatric maintenance study (TKT029) will be submitted upon completion.
Analiżi farmakokinetika addizzjonali minn studju ta 'manteniment pedjatriku (TKT029) għandu jiġi sottomess mat- tlestija.
Adverse events Adverse events from study TKT023 and any other available data for paediatric patients will be analysed by age and submitted in the next Annual Re-Assessment.
Każijiet avversi Każijiet avversi mill- istudju TKT023 u kull dejta disponibbli oħra minn pazjenti pedjatriċi ser tiġi analizzata skond l- età u għandha tiġi sottomessa għall- eżami li jmiss ta 'kull sena.
The company will elucidate if the reported adverse events pain exacerbation, reactions to infusions, nasopharyngitis, and cough occur relatively more frequently in the younger children (versus the older children) and/ or if this phenomenon is due to relative overdosing.
Il- kumpanija ser tiċċara jekk l- effetti avversi rapportati jħarxux aktar l- uġigħ, ir- reazzjonijiet għall- infużjonijiet, il- farinġite nażali u s- sogħla jseħħux relattivament aktar ta 'spiss fi tfal iżgħar (meta mqabbla mat- tfal akbar) u/ jekk dan il- fenomenu jseħħx minħabba doża eċċessiva.
OUTER CARTON / 3.5 ML VIAL
KARTUNA TA 'BARRA / KUNJETT TA' 3. 5 ML
Replagal 1 mg/ ml concentrate for solution for infusion Agalsidase alfa
Replagal 1 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Agalsidase alfa
One vial contains 3.5 mg of agalsidase alfa
Kull kunjett fih 3. 5 mg ta 'agalsidase alfa.
Sodium phosphate monobasic, monohydrate polysorbate 20 sodium chloride sodium hydroxide water for injections
Sodium phosphate monobasic, monohydrate Polysorbate 20 sodium chloride sodium hydroxide ilma għall- injezzjonijiet
1 x 3.5 ml concentrate for solution for infusion 4 x 3.5 ml concentrate for solution for infusion 10 x 3.5 ml concentrate for solution for infusion
Replagal 1 x 3. 5 ml konċentrat għal soluzzjoni għall- infużjoni Replagal 4 x 3. 5 ml konċentrat għal soluzzjoni għall- infużjoni Replagal 10 x 3. 5 ml konċentrat għal soluzzjoni għall- infużjoni
Intravenous use Read the package leaflet before use
Użu għal ġol- vini Aqra l- fuljett ta 'tagħrif qabel l- użu
{mon/ year} Use within 3 hours after dilution
{xahar/ sena} Uża fi żmien 3 sigħat wara d- dilwazzjoni
VIAL 3.5 ML PRESENTATION
PREŻENTAZZJONI TAL- KUNJETT TA '3. 5 ML
Replagal 1 mg/ ml sterile concentrate Agalsidase alfa Intravenous use
Replagal 1 mg/ ml konċentrat sterili Agalsidase alfa Użu għal ġol- vini
Read the package leaflet before use
Aqra l- fuljett ta 'tagħrif qabel l- użu
{mon/ year}
{xahar/ sena}
OUTER CARTON / 1 ML VIAL
KARTUNA TA 'BARRA / KUNJETT TA' 1 ML
One vial contains 1 mg of agalsidase alfa
Kull kunjett fih 1 mg ta 'agalsidase alfa.
1 x 1 ml concentrate for solution for infusion 4 x 1 ml concentrate for solution for infusion 10 x 1 ml concentrate for solution for infusion
1 x 1 ml konċentrat għal soluzzjoni għall- infużjoni 4 x 1 ml konċentrat għal soluzzjoni għall- infużjoni 10 x 1 ml konċentrat għal soluzzjoni għall- infużjoni
{mon/ year} Use within 3 hours after dilution
JIS {xahar/ sena} Uża fi żmien 3 sigħat wara d- dilwazzjoni
18 Store in a refrigerator
18 Aħżen fi friġġ.
VIAL 1 ML PRESENTATION
PREŻENTAZZJONI TA 'KUNJETT TA' 1 ML
{mon/ year}
JIS {xahar/ sena}
21 PACKAGE LEAFLET:
21 FULJETT TA 'TAGĦRIF:
What Replagal is and what it is used for 2.
X' inhu Replagal u għalxiex jintuża 2.
Before you take Replagal 3.
Qabel ma tieħu Replagal 3.
How to take Replagal 4.
Kif għandek tieħu Replagal 4.
How to store Replagal 6.
Kif taħżen Replagal 6.
WHAT REPLAGAL IS AND WHAT IT IS USED FOR
X' INHU REPLAGAL U GĦALXIEX JINTUŻA
The active substance in Replagal is agalsidase alfa (1mg/ ml).
Is- sustanza attiva ta 'Replagal hi agalsidase alfa (1 mg/ ml).
Agalsidase alfa is a form of the human enzyme α -galactosidase.
Agalsidase alfa hi għamla ta 'l- enżima umana ta' α- galactosidase.
It is produced by switching on the gene for α -galactosidase A in cells.
Hija prodotta billi jiġi stimulat il- ġene għal α- galactosidase A fiċ- ċelloli.
The enzyme is then removed from the cells and made into a sterile concentrate for solution for infusion.
L- enżima mbagħad tiġi miġbura miċ- ċelloli u ssir f' konċentrat sterili għal soluzzjoni għall- infużjoni.
Replagal is used to treat Fabry Disease.
Replagal jiġi użat biex jittratta il- Marda ta 'Fabry.
It is used as enzyme replacement therapy when the level of enzyme in the body is lower than normal as in Fabry Disease.
Huwa jintuża bħala terapija ta 'sostituzzjoni ta' l- enżima meta l- livell ta 'enżima fil- ġisem ikun inqas minn normal bħal fil- Marda ta' Fabry.
BEFORE YOU TAKE REPLAGAL
QABEL MA TIEĦU REPLAGAL
Do not take Replagal If you are allergic (hypersensitive) to agalsidase alfa or any of the other ingredients of Replagal.
Tieħux Replagal Jekk int allerġiku/ a (tbagħti minn sensittività eċċessiva) għal agalsidase alfa jew sustanzi oħra ta 'Replagal.
Take special care with Replagal If you notice any of these effects during or after an infusion you should tell your doctor immediately:
Oqgħod attent ħafna b' Replagal Jekk tinduna b' xi wieħed minn dawn l- effetti waqt jew wara l- infużjoni għandek tgħid lit- tabib tiegħek minnufih:
- high fever, chills, sweating, fast heart rate;
- deni għoli, tertir, għariq, il- qalb tħabbat b' mod aktar mgħaġġel;
- vomiting;
- remettar;
- light-headedness;
- rasek mhux f' postha;
- hives, itching or rash;
- ħorriqija, ħakk jew raxx;
- swelling in your hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in
- tinfiħ ta 'l- idejn, ir- riġlejn, l- għakiesi, il- wiċċ, ix- xofftejn, il- ħalq jew il- griżmejn li jistgħu
swallowing or breathing;
jikkawżaw diffikultà biex tibla 'jew tieħu n- nofs;
- pain or tenderness in chest, muscles or joints.
- uġigħ jew tenerezza fis- sider, il- muskoli jew il- ġogi.
Your doctor may stop the infusion temporarily (5 – 10 min) until the symptoms go away and then begin the infusion again.
It- tabib tiegħek għandu mnejn iwaqqaf l- infużjoni temporanjament (5 – 10 min) sakemm is- sintomi jmorru u mbagħad jibda 'l- infużjoni mill- ġdid.
Your doctor may also treat the symptoms with other medicines (antihistamines or corticosteroids).
It- tabib tiegħek għandu mnejn jittratta sintomi oħra b' mediċini oħra (antiħistamini jew kortikosterojdi).
Most of the time you can still be given Replagal even if these symptoms occur.
Ħafna drabi xorta tista 'tingħata Replagal anke jekk dawn is- sintomi jseħħu.
If you experience a severe allergic (anaphylactic-type) reaction, the administration of Replagal will be immediately discontinued and an appropriate treatment will have to be initiated by your doctor.
22 Jekk ikollok reazzjoni allerġika qawwija (tip anafilattika), l- għoti ta 'Replagal ser jitwaqqaf minnufih u trattament xieraq għandu jiġi mibdi mit- tabib tiegħek.
22 If treatment with Replagal makes your body produce antibodies this will not stop Replagal working and the antibodies may disappear with time.
Jekk it- trattament b' Replagal iġiegħel 'il ġismek jipproduċi antikorpi, dan mhux ser iwaqqaf' il Replagal milli jaħdem u l- antikorpi jistgħu jisparixxu biż- żmien.
Use in Children Replagal has not yet been studied in children less than 6 years old and there is only limited clinical data in children 7-18 years old.
Użu fi Tfal Replagal ma ġiex studjat fi tfal li għandhom inqas minn 6 snin u hemm biss dejta klinika ristretta għal tfal ta ’ bejn is- 7- 18- il sena.
No unexpected safety issues were encountered in the studies with Replagal in children 7-18 years of age.
L- ebda kwistjonijiet mhux mistennija dwar sigurtà ma ġew inkontrati fl- istudji b' Replagal fi tfal bejn 7- 18- il sena.
Using other medicines There is no known interaction of Replagal with other medicines.
Meta tieħu mediċini oħra Mhux magħruf li Replagal ikollu xi effetti oħra ma 'mediċini oħra.
Taking Replagal with food and drink Interactions with food or drink are unlikely.
Meta tieħu Replagal ma ’ l- ikel u max- xorb Effetti ma 'l- ikel u x- xorb m' humiex probabbli.
Pregnancy and breast feeding Very limited clinical data on pregnancies exposed to Replagal (n=4) have shown no adverse effects on the mother and newborn child.
Tqala u treddigħ Tagħrif minn numru limitat (n=4) ta 'użi waqt it- tqala juri li m' hemm l- ebda effetti mhux mixtieqa fuq is- saħħa ta' l- omm u t- tarbija tat- twelid.
Driving and using machines You may drive and operate machinery whilst on Replagal.
Sewqan u tħaddim ta 'magni Tista' issuq u tħaddem l- inġenji meta tkun qed tieħu Replagal.
HOW TO TAKE REPLAGAL
KIF GĦANDEK TIEĦU REPLAGAL
Replagal has to be diluted in 9 mg/ ml (0.9%) sodium chloride solution before use.
Replagal għandu jiġi dilwit f' 9 mg/ ml (0. 9%) ta 'soluzzjoni ta' sodium chloride qabel ma jintuża.
After dilution Replagal is given in a vein.
Wara li jiġi dilwit Replagal għandu jingħata ġol- vina.
This will usually be in your arm.
Dan ġeneralment ikun fid- driegħ.
The usual dose is an infusion of 0.2 mg for every kg you weigh.
Id- doża ġeneralment hi ta '0. 2 mg għal kull kg ta' piż tiegħek.
This would be about 14 mg or 4 vials (glass bottles) of Replagal for an average size (70 kg) individual.
Dan ikun madwar 14 mg jew 4 kunjetti (fliexken tal- ħġieġ) ta 'Replagal għal individwu ta' daqs medju (70 kg).
The infusion will be given every two weeks.
L- infużjoni għandha tingħata kull ġimagħtejn.
Each time you are treated it will take 40 minutes for Replagal to be given to you in a vein.
Kull darba li tiġi trattat ser iddum 40 minuta għal Replagal biex jingħata ġol- vina tiegħek.
Your treatment will be supervised by a doctor who specialises in the treatment of Fabry Disease.
It- trattament tiegħek ser jiġi sorvelljat minn tabib li jispeċjalizza fit- trattament tal- Marda ta 'Fabry.
If you forget to have Replagal If you have missed a Replagal infusion, please contact your doctor.
Jekk tinsa tieħu Replagal Jekk tkun immissjajt infużjoni ta 'Replagan, jekk jogħġbok ikkuntattja lit- tabib tiegħek.
Like all medicines, Replagal can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Replagal jista ’ jkollu effetti kollaterali, għalkemm ma jidhrux fuq kulħadd.
Most side effects are mild to moderate.
Ħafna mill- effetti kollaterali huma minn ħfief għal moderati.
About 1 out of 7 patients may have a reaction during or following an infusion of Replagal.
Madwar 1 minn 7 pazjenti jista 'jkollu reazzjoni matul jew wara infużjoni ta' Replagal.
These effects include chills, headache, nausea, fever, facial flushing (redness) and tiredness.
Dawn l- effetti jinkludu sirdat, uġigħ ta 'ras, dardir, deni, fwawar fil- wiċċ (ħmurija) u għejja.
However some effects may be serious and may need treatment.
Madankollu xi effetti jistgħu jkunu serji u għandhom mnejn ikunu jeħtieġu t- trattament.
Very common side effects (occurring in more than 1 in 10 treated patients) include the following:
Effetti kollaterali komuni ħafna (li jseħħu f' aktar minn 1 minn 10 pazjenti trattati) jinkludu dawn li ġejjin:
- headache
- uġigħ ta 'ras
- flushing (redness)
- fwawar (ħmura)
- chills, fever
- sirdat, deni;
- general pain or discomfort, tiredness.
- uġigħ ġenerali jew skumdità, għejja.
23 Common side effects (occurring in less than 1 in 10 treated patients) include the following:
Effetti kollaterali komuni (li jseħħu f' aktar minn 1 minn 10 pazjenti trattati) jinkludu dawn li ġejjin:
- tingling or numbness or pain in fingers or toes, change in the taste of food, eyes tearing, ears
- tnemin jew tirżiħ jew uġigħ fis- swaba ta 'l- id jew tas- saqajn, bidla fit- togħma ta' l- ikel, l -
ringing, shakes, unsteadiness, prolonged sleep
għajnejn idemmgħu, il- widnejn iċċenċnu, tregħid, ma tħossokx stabbli, tibqa 'rieqed
- palpitations, increased heart rate, increased blood pressure
- palpitazzjonijiet, il- qalb tħabbat aktar, pressjoni tad- demm ogħla
- cough, chest pain or tightness, hoarseness, sore or tight throat, sticky throat secretions, runny
- sogħla, uġigħ jew issikkar fis- sider, hanqa, uġigħ jew issikkar fil- griżmejn, katarru maqgħud
nose
tal- griżmejn, imnieħer iqattar
- vomiting, abdominal pain or discomfort, diarrhoea
- remettar, uġigħ addominali jew skumdità, dijarrea
- acne, red or itchy or mottled skin, rash at the infusion site
- akne, ġilda ħamra, jew li ġgagħlek tħokk jew bi tbajja ', raxx fis- sit ta' l- infużjoni
- back or limb pain, swelling of the extremities or joints
- uġigħ fid- dahar jew fid- driegħ/ riġel, nefħa fil- partijiet periferiċi jew fil- ġogi
- feeling cold or hot, flu-like symptoms, malaise
- tħossok kiesaħ jew sħun, sintomi bħal tad- deni, tħossok ma tiflaħx
HOW TO STORE REPLAGAL
KIF TAĦŻEN REPLAGAL
Do not use Replagal after the expiry date which is stated on the label after the letters EXP.
Tużax Replagal wara d- data ta ’ skadenza li tidher fuq it- tikketta wara JIS.
Do not use Replagal if you notice that there is discolouration or other foreign particles present.
Tużax Replagal jekk tinduna b' tibdil fil- kulur jew frak li mhux suppost qiegħed hemm.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill- ispiżjar dwar kif għandek tarmi mediċini li m' għandekx bżonn.
What Replagal contains
X' fih Replagal
- The active substance is agalsidase alfa
- Is- sustanza attiva hija agalsidae alfa.
Sodium phosphate monobasic, monohydrate
Sodium phosphate monobasic, monohydrate
Polysorbate 20 Sodium chloride Sodium hydroxide Water for injections
Polysorbate 20 Sodium chloride Sodium hydroxide Ilma għall- injezzjonijiet
What Replagal looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett
Replagal is a concentrate for solution for infusion.
Replagal hu konċentrat għal soluzzjoni għall- infużjoni.
Your medicine is available in vials containing either 1 mg/ 1 ml or 3.5 mg/ 3.5 ml of agalsidase alfa.
Il- mediċina tiegħek tiġi f' kunjetti li fihom jew 1 mg/ 1 ml jew 3. 5 mg/ 3. 5 ml ta 'agalsidase alfa.
Pack sizes of 1, 4 or 10 vials are available.
Daqsijiet tal- pakkett ta '1, 4 jew 10 kunjetti huma disponibbli.
Marketing Authorisation Holder
24 Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq
Manufacturer Shire Human Genetic Therapies AB, Åldermansgatan 2, Box 1117, 221 04 Lund, Sweden
Shire Human Genetic Therapies AB, Åldermansgatan 2, Box 1117, 221 04 Lund, L- Iżvezja
24 This leaflet was last approved in:
Dan il- fuljett kien approvat l- aħħar f '
This medicine has been authorised under “ exceptional circumstances”.
Din il- mediċina kienet awtorizzat taħt “ ċirkustanzi ta 'eċċezzjoni ”.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Dan ifisser li minħabba li l- marda li qed tbati minnha hija rari ma kien impossibbli li tinkiseb informazzjoni kompleta dwar din il- mediċina.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: 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 u kura.
------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
--------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Instructions for use, handling and disposal
Struzzjonijiet għal użu, l- immaniġġjar u r- rimi
Calculate the dose and number of Replagal vials needed.
Ikkalkula d- doża u l- għadd ta 'kunjetti ta' Replagal meħtieġa.
Dilute the total volume of Replagal concentrate required in 100 ml 9 mg/ ml sodium chloride solution for infusion (0.9%w/ v).
Iddilwa l- volum totali tal- konċentrat ta 'Replagal meħtieġ f' 100 ml ta' 9 mg/ ml soluzzjoni ta 'sodium chloride għall- infużjoni (0. 9% w/ v).
Care must be taken to ensure the sterility of the prepared solutions since Replagal does not contain any preservative or bacteriostatic agent; aseptic technique must be observed.
Attenzjoni għandha tingħata biex tiżgura l- isterilità tas- soluzzjonijiet ippreparati peress li Replagal ma fihx priservattivi jew aġent batterjoloġiku; għandha tiġi osservata teknika asettika.
The solution should be inspected visually for particulate matter and discolouration prior to administration.
Qabel l- għoti, is- soluzzjoni għandha tiġi spezzjonata viżwalment għal frak u tibdil fil- kulur.
Administer the infusion solution over a period of 40 minutes using an intravenous line with an integral filter.
Agħti s- soluzzjoni ta 'l- infużjoni ġol- vina permezz ta' pajp li għandu filter integrat fuq perijodu ta '40 minuta.
However, the chemical and physical stability of the diluted solution has been demonstrated for 24 hours at 25°C.
Madankollu, l- istabbilità kimika jew fiżika tas- soluzzjoni dilwita ntweriet għal 24 siegħa f' temperatura ta '25°C.
Do not infuse Replagal concomitantly in the same intravenous line with other agents.
M' għandekx tinfuża Replagal ġol- vina fl- istess pajp ma 'mediċini oħrajn.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
The Member States shall ensure that prior to launch the Marketing Authorisation Holder provides health care professionals in dialysis centres and retail pharmacies with:
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
• Educational leaflet • Summary of product characteristics (SPC) and Package Leaflet and Labelling
• Fuljett edukattiv • Sommarju tal- Karatteristiċi tal- Prodott (SPC) u Fuljett ta ’ Tagħrif u Tikketta
The educational leaflet shall contain the following key elements: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA) • That with other epoetin products, the risk of immunogenicity in Chronic Renal Failure (CRF) is increased with the subcutaneous route. • There is insufficient data on Silapo/ Retacrit to know the size of any increased immunogenicity risk with subcutaneous use • Therefore, the sc route is not recommended for patients with CRF • Loss of efficacy or other symptoms of the development of immunogenicity should be investigated • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Il- fuljett edukattiv għandu jkun fih l- elementi importanti li ġejjin: • Li l- użu tal- prodotti li fihom epoetin alfa jistagħu jikkawżaw immunoġeniċità li f’ każijiet rari tista’ twassal għal Aplasija taċ- Ċelluli l- Ħomor Pura (PRCA) • Li ma ’ prodotti oħrajn ta ’ epoetin, ir- riskju ta ’ immunoġeniċità f’ Mard Kroniku tal- Kliewi (CRF) jiżdied meta jingħata minn taħt il- ġilda (sc). • Hemm informazzjoni insuffiċjenti fuq Retacrit biex ikun magħruf il- kobor ta ’ xi żieda fir- riskju ta ’ immunoġeniċità bl- użu minn taħt il- ġilda • Għalhekk, ir- rotta ta ’ taħt il- ġilda mhix rakkomandata għal pazjenti li għandhom CRF • It- telf ta ’ effikaċja jew sintomi oħrajn ta ’ l- iżvilupp ta ’ immunoġeniċità għandhom ikunu investigati • Kwalunkwe każ suspettat ta ’ Aplasija taċ- Ċelluli l- Ħomor Pura jew l- iżvilupp ta ’ immunoġeniċità għandhom ikunu rrappurtati lill- MAH
What is Retacrit?
X’ inhu Retacrit?
Retacrit is a solution for injection.
Retacrit huwa soluzzjoni għall- injezzjoni.
It is available in pre-filled syringes containing between 1,000 and 40,000 international units (IU) of the active substance, epoetin zeta.
Huwa disponibbli f’ siringi mimlija minn qabel li fihom bejn 1, 000 u 40, 000 unità internazzjoni (IU) tas- sustanza attiva, epoetin zeta.
Retacrit is a ‘ biosimilar’ medicine.
Retacrit huwa mediċina ‘ bijosimili ’.
This means that Retacrit is similar to a biological medicine that is already authorised in the European Union (EU) and contains a similar active substance (also known as the ‘ reference medicine’).
Dan ifisser li Retacrit jixbah lil mediċina bijoloġika li diġà hija awtorizzata fl- Unjoni Ewropea (UE) u li fiha sustanza attiva simili (magħrufa bħala ‘ mediċina ta ’ referenza ’).
The reference medicine for Retacrit is EPREX/ ERYPO, which contains epoetin alfa.
Il- mediċina ta ’ referenza għal Retacrit hi EPREX/ ERYPO, li fih epoetin alfa.