qanastek/EMEA-V3 huggingface dataset:
Recombinant coagulation factor IX is a recombinant DNA-based protein therapeutic which has structural and functional characteristics comparable to endogenous factor IX.
60 rikombinanti li għandha karatteristiċi strutturali u ta ’ funzjoni komparabbli mal- fattur IX endoġenu.
72 Table 1.
Parametru
Recombinant Factor IX Parameters for Activity Data by Month in Previously Treated Patients
Xahar n Medja Medjan SD Medda 95% CI 30. 9, 36. 4 15. 3 – 62. 2 10. 31 31. 5 33. 7 56
Month n Mean Median SD Range 95% CI 0 56 33.7 31.5 10.31 15.3– 62.2 30.9, 36.4 6 53 31.8 31.0 9.04 15.3– 56.7 29.4, 34.3 12 50 31.3 30.5 8.75 16.2 – 53.1 28.8, 33.7 18 47 30.7 28.9 9.24 12.6– 62.1 28.0, 33.5 24 47 31.0 30.6 8.80 16.2– 59.4 28.4, 33.6
0 29. 4, 34. 3 15. 3 – 56. 7 9. 04 31. 0 31. 8 53 6 28. 8, 33. 7 16. 2 – 53. 1 8. 75 30. 5 31. 3 50 12 28. 0, 33. 5 12. 6 – 62. 1 9. 24 28. 9 30. 7 47 18 28. 4, 33. 6 16. 2 – 59. 4 8. 80 30. 6 31. 0 47 24 0. 69, 0. 81 0. 34 – 1. 38 0. 23 0. 70 0. 75 56
0 56 0.75 0.70 0.23 0.34– 1.38 0.69, 0.81 6 53 0.71 0.69 0.20 0.34– 1.26 0.65, 0.76 12 50 0.70 0.68 0.19 0.36 – 1.18 0.64, 0.75 18 47 0.68 0.64 0.21 0.28– 1.38 0.62, 0.74 24 47 0.69 0.68 0.20 0.36– 1.32 0.63, 0.75
0 0. 65, 0. 76 0. 34 – 1. 26 0. 20 0. 69 0. 71 53
Elimination half-life (hrs)
(IU/ dl għal kull
0 56 19.3 19.1 4.97 11.1– 36.4 18.0, 20.7 6 53 19.8 18.2 6.26 9.6– 38.2 18.1, 21.6 12 49 18.5 16.6 5.89 10.6 – 33.7 16.8, 20.2 18 46 18.9 16.3 7.02 10.7– 38.3 16.8, 21.0 24 45 18.9 17.3 6.84 10.9– 42.2 16.8, 20.9
6 0. 64, 0. 75 0. 36 – 1. 18 0. 19 0. 68 0. 70 50
AUC0- ∞ (IU × hr/ dl) Half-life
IU/ kg)
0 56 619.8 605.2 155.7 366.5– 1072.6 578.1, 661.5 6 53 579.8 562.2 146.1 330.9– 900.1 539.5, 620.1 12 49 575.7 566.0 151.0 290.3 – 1080.8 532.4, 619.1 18 46 561.8 560.9 155.6 254.5– 940.8 515.7, 608.0 24 45 577.6 551.7 154.7 284.1– 1045.4 531.1, 624.1 0 54 2.0 1.5 1.60 0.07-5.73 1.6,2.5
12 0. 62, 0. 74 0. 28 – 1. 38 0. 21 0. 64 0. 68 47 18 0. 63, 0. 75 0. 36 – 1. 32 0. 20 0. 68 0. 69 47 24 18. 0, 20. 7 11. 1 – 36. 4 4. 97 19. 1 19. 3
Initial Phase (hrs)
Half- life ta 'l -
6 12 18 24
0 56 18. 1, 21. 6 9. 6 – 38. 2 6. 26 18. 2 19. 8
52 48 44 43
eliminazzjoni
2.3 2.2 2.0 1.8
6 53 16. 8, 20. 2 10. 6 – 33. 7 5. 89 16. 6 18. 5
1.0 1.2 1.3 0.78
(sigħat) AUC0- ∞ (IU x hr/ dl)
2.62 2.70 1.94 2.07
Half- life
0.12-9.98 0.13-14.34 0.13-6.21 0.11-7.43
0 54 1. 5, 3. 0 0. 12 - 9. 98 2. 62 1. 0 2. 3
1.5,3.0 1.5,3.0 1.4,2.6 1.1,2.4
Inizzjali (sigħat)
8.4 9.2 9.3 9.6 9.2
Wyeth Europa Ltd.
8.2 8.9 8.8 8.9 9.1
EU/ 1/ 97/ 047/ 006
2.01 2.48 2.53 2.85 2.40
GĦAMLA FARMAĊEWTIKA
4.66-13.64 5.55-15.11 4.63-17.22 5.31-19.65 4.78-17.60
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
7.86,8.94 8.53,9.89 8.56,10.01 8.78,10.47 8.52,9.96
żjieda ta ’ fattur IX X mixtieqa (%) jew (IU/ dl)
MRT (hrs)
piż tal- ġisem (f’ kg)
0 6 12 18 24
4. 6 Tqala u treddigħ
56 53 49 46 45
Mhux komuni:
26.0 25.6 24.6 24.7 25.1
Rari:
25.8 25.3 22.2 22.7 23.9
Disturbi ġenerali u
6.07 5.68 6.47 7.40 6.94
oħra aktar `l isfel.
15.81-46.09 13.44-42.26 14.83-38.75 15.30-50.75 15.65-47.52
F’ xi każi, dawn ir- reazzjonijiet wasslu għal anaflassi serja.
24.35,27.60 24.01,27.15 22.75,26.47 22.55,26.94 23.00,27.17
Jista ’ jkun hemm l- effett ta ’ sensittività eċċessiva.
Data exclude those collected from one patient after evidence of inhibitor development was observed at 9 months.
4. 9 Doża eċċessiva
AUC0 - ∞ = Area Under the Curve MRT = Mean Residence Time SD = Standard Deviation CI = Confidence Interval
B02BD09
A 28% lower recovery of recombinant Factor IX in comparison to plasma derived Factor IX was shown.
BeneFIX fih il- fattur IX, (Nonacog alfa) tal- koagulazzjoni rikombinanti.
Pharmacokinetic parameters of recombinant Factor IX have also been determined after single and multiple
Dan jikkawża t- tibdil ta ’ prothrombin fi thrombin.
73 intravenous doses in different species.
Din il- mediċina kienet awtorizzata taħt ‘ Ċirkustanzi ta ’ Eċċezzjoni ’.
The pharmacokinetic parameters obtained in studies comparing recombinant Factor IX to plasma derived Factor IX were similar to those obtained in human studies.
L- infużjoni ta ’ BeneFIX f’ 56 pazjent PTP (informazzjoni referenzjali) li jbatu bl- emofilja B uriet irkupru in vivo li jvarja bejn il- 15% u t- 62% (medja ta ’ 33. 7 + / - 10. 3%).
Structural differences of the recombinant Factor IX molecule compared with plasma derived Factor IX appear to contribute to the different recovery compared to plasma derived Factor IX.
Il- half- life bijoloġiku kien ivarja bejn 11 u 36 siegħa (medja ta ’ 19. 3 + / - 5. 0 sigħat).
5.3 Preclinical safety data
(sigħat) AUC0- ∞ (IU x hr/ dl)
Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity.
L- informazzjoni teskludi dik miġbura minn pazjent wieħed wara evidenza li żviluppa impeditur wara 9 xhur.
74 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
2000 IU of powder in a 10 ml vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium) and 5 ml of solvent in a prefilled syringe (type 1 glass) with a plunger stopper (bromobutyl), a tip-cap (bromobutyl) and a sterile vial adapter reconstitution device, a sterile infusion set, two alcohol swabs, a plaster, and a gauze pad.
2000 IU ta 'trab f’ kunjett ta' 10 ml (ħġieġ ta 'tip 1) b' tapp (chlorobutyl) u siġill flip- off (aluminju) u 5 ml ta' solvent f' siringa mimlija għal- lest (ħġieġ ta 'tip 1) b' tapp- planġer (bromobutyl), għatu tat- tarf (bromobutyl) u adapter sterili tal- kunjett tat- tagħmir tar- rikostituzzjoni, sett sterili ta' l- infużjoni, żewġ biċċiet bl- alkoħol biex tnaddaf, stikka, u pad tal- garża.
6.6 Special precautions for disposal and other handling
73 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
75 ANNEX II
74 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA 'L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Wyeth BioPharma One Burtt Road Andover MA 01810 USA
Wyeth BioPharma One Burtt Road Andover MA 01810 Stati Uniti ta ’ l- Amerika
Sebastian de los Reyes, Madrid Spain
Sebastian de los Reyes, Madrid Spanja
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all physicians who are expected to prescribe/ use BeneFIX are provided with an Educational pack containing the following: • Physician information pack • Patient information pack
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) għandu jiżgura li, fit- tnedija tal - prodott, it- tobba kollha li huma mistennija li jagħtu riċetta/ jużaw BeneFIX, jingħataw pakkett edukattiv li jkun fih dan li ġej: • Pakkett ta 'tagħrif għat- tobba • Pakkett ta' tagħrif għall- pazjent
Both information packs are to be used as part of an educational plan provided to minimise risk of medication errors that may be associated with transition to reformulated BeneFIX and a new strength of BeneFIX.
Iż- żewġ pakketti ta 'l- informazzjoni huma biex jintużaw bħala parti minn pjan edukattiv biex jimminimizzaw ir- riskju ta' żbalji tal- mediċina li huma assoċjati mat- transizzjoni għar- riformulazzjoni ta 'BeneFIX u qawwa ġdida ta' BeneFIX.
The physician information pack should contain the following key elements: • Summary of product characteristics, including highlighted changes that have been made for reformulated BeneFIX • Clear demarcation of reformulated BeneFIX from original BeneFIX, with clear descriptions of new EU-specific packaging for reformulated BeneFIX. • Training kit and instructions on step-by-step use of the R2 reconstitution kit. • Transition management information regarding administration of new reformulated BeneFIX, prohibition of mixing up with current BeneFIX, and information about use of the new 2000 IU dosage vial. • Information regarding the changed solvent type from sterile water to 0.234% normal saline, and regarding reduced solvent volume for some dosage vials.
Il- pakkett ta 'tagħrif għat- tobba għandu jinkludi dawn l- elementi ewlenin li ġejjin: • Sommarju tal- karatteristiċi tal- prodott, li jinkludu enfasi fuq il- bidliet li saru għal BeneFIX riformulat. • Demarkazzjoni ċara ta' BeneFIX riformulat minn BeneFIX oriġinali, b' deskrizzjonijiet ċari ta 'l- ippakkjar il- ġdid li hu speċifiku għall- UE għal BeneFIX riformulat. • Kitt ta' taħriġ u struzzjonijiet pass pass dwar l- użu tal- kitt tar- rikostituzzjoni R2. • Informazzjoni dwar l- immaniġġjar tat- transizzjoni dwar l- għoti ta 'BeneFIX riformulat mill - ġdid, il- projbizzjoni li tħallat BeneFIX eżistenti, u informazzjoni dwar l- użu tal- kunjett l- ġdida tad- dożaġġ ta' 2000 IU. • Informazzjoni dwar it- tip ta 'solvent mibdul minn ilma sterili għal 0. 234% ilma mielaħ normali, u dwar il- volum imnaqqas tas- solvent għal xi fjali tad- dożaġġ.
Together with highlighting of the correct technique of application this should aim at risk minimisation of red blood cell agglutination.
Flimkien ma 'l- enfasi tat- teknika korrett ta' l- applikazzjoni, dan għandu ul- għan li jimminimizza r- riskju ta 'agglutinazzjoni taċ- ċelluli ħomor tad- demm.
The patient information pack to be used by health care professionals in education of the patients: • Patient information leaflet
76
77 • R2 training kit • Visualisation material for correct reconstitution and administration of the product • Instructions to patients to deplete their supply of current BeneFIX through their usual usage schedule before starting reformulated BeneFIX.
Fuljett ta ’ Tagħrif għall- Pazjent Kitt ta 'taħriġ R2 Materjal viżiv għar- rikostituzzjoni u għall- għoti korretti tal- prodott.
This will involve using vials of original BeneFIX product along with the appropriate use of accompanying original BeneFIX sterile water solvent. • Instructions that patients should not mix vials of current and reformulated product for a given dose prior to transition to the new reformulated BeneFIX, and necessity not to mix up these two products.
Dan ser jinvolvi l- użu tal - fjali tal- prodott oriġinali ta 'BeneFIX flimkien ma' l- użu kif suppost tas- solvent ta 'l- ilma sterili ta' BeneFIX l- oriġinali.
The MAH must ensure that the system of pharmacovigilance, as described in version dated April 2006 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
L- MAH irid jiżgura li s- sistema ta ’ farmako- viġilanza, kif deskritt fil- verżjoni sottomessa f’ April 2006, ippreżentata f' Modulu 1. 8. 1. ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel ma l- prodott jibda jinbiegħ.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version dated 19 April 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta 'l- Awtorizzazzjoni tal- Manifattura jrid ikun obbligat li jwettaq l- istudji u attivitajiet ta' farmakoviġilanza addizzjonali deskritti fil- pjan tal- Farmakoviġilanza, kif maqbul fil- verżjoni bid- data tad- 19 t' April, 2007, tal- Pjan dwar l- Immaniġġjar tar- Riskju (RMP) ippreżentat f' Modulu 1. 8. 2. ta 'l - Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskji għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (Periodic Safety Update Report (PSUR) li jkun imiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Flimkien ma 'dan, RMP aġġornat għandu jkun sottomess • Meta informazzjoni ġdida tkun irċevuta li jista' jkollha jkollha impatt fuq l- Ispeċifazzjoni tas - Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jimminimizzaw ir- riskju. • Fi żmien 60 jum minn meta tintlaħaq milestone importanti (Farmakoviġilanza jew minimizzazzjoni tar- riskju) • Fuq talba tal- EMEA
The MAH will submit 6-monthly PSURs unless otherwise specified by the CHMP.
L- MAH ser jissottometti PSURs kull 6 xhur, sakemm ma jkunx speċifikat mod ieħor mis- CHMP.
Specific Obligations (Clinical)
Obbligi Speċifiċi (Kliniċi)
Registry for ALL NEW PATIENTS treated with BeneFIX in Europe.
Reġistru fejn jitniżżlu l- PAZJENTI ĠODDA KOLLHA kkurati b’ BeneFIX fl- Ewropa.
The MAH commits to continuing this registry until the CPMP has accepted the data of the new PTP and children ’ s studies.
Il- MAH iwiegħed li jkompli dan ir- reġistru sakemm is- CPMP tkun aċċettat l- informazzjoni ta ’ l- istudji l- ġodda dwar il- PTP u t- tfal.
Reports are awaited every 6 months.
Ir- rapporti huma mistennija kull 6 xhur.
78 ANNEX III
77 ANNESS III
LABELLING
79 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BeneFIX 250 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX)
BeneFIX 250 IU trab u solvent għal soluzzjoni għall- injezzjoni Nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti)
Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX).
Kull kunjett nominalment ikun fih 250 IU nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti).
After reconstitution with the accompanying 5 ml water for injection, each ml of the solution contains approximately 50 IU.
Wara r- rikostituzzjoni bil- 5 ml ta ’ ilma għall- injezzjonijiet ipprovdut, kull ml ta ’ soluzzjoni jkun fih madwar 50 IU.
Sucrose, Glycine, L-histidine, Polysorbate 80 and Water for injections.
Sucrose, Glycine, L- histidine, Polysorbate 80 u Ilma għall- injezzjonijiet
One vial with powder for solution for injection contains nonacog alfa 250 IU and excipients One vial of 5 ml water for injections One double-ended needle One filter spike One mini sterile infusion set One 10 ml sterile disposable syringe for administration Two alcohol swabs Two plasters
Kunjett wieħed bit- trab għal soluzzjoni għall- injezzjoni fih nonacog alfa 250 IU u sustanzi mhux attivi Kunjett wieħed ta ’ 5 ml ilma għall- injezzjonijiet Labra b’ żewġ trufijiet Labra rqiqa tal- filtru Mini- sett sterili wieħed ta ’ l- infużjoni Siringa sterilizzata li tintrema wara li tintuża ta ’ 10 ml għat- teħid Żewġ biċċiet bl- alkoħol Żewġ garżi
For intravenous use, single use administration only.
Użu għal ġol- vini, għandu jintuża darba biss.
81 EXP {MM/ YYYY}
JIS {XX/ SSSS}
Store and transport refrigerated (2°C - 8°C).
Żommu kiesaħ waqt il- ħażna u l- ġarr (2°C – 8°C) Tagħmlux fil- friża.
BeneFIX powder for solution for injection can be stored below 25ºC for up to 1 month, without being refrigerated again during this period and must be discarded if not used after this.
BeneFIX trab għal soluzzjoni għall- injezzjoni jista ’ jinħażen f’ temperatura taħt 25ºC sa xahar, mingħajr ma jitpoġġa fil- friġġ mill- ġdid matul dan il- perijodu, u għandu jintrema jekk ma jintużax wara dan il- perijodu.
Date of setting at temperature not exceeding 25°C:
Data ta 'meta tpoġġa f' temperatura ta' mhux iktar minn 25°C:
Date to which the bottle must be withdrawn:
Data meta l- flixkun għandu jintrema:
Use immediately or within 3 hours of reconstitution.
Uża immedjatament jew fi żmien 3 sigħat mir- rikostituzzjoni.
Lot Potency
Lott Qawwa
82 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
81 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
BeneFIX 250 IU powder for solution for injection Nonacog alfa (recombinant coagulation factor IX) Intravenous use
BeneFIX 250 IU trab għal soluzzjoni għall- injezzjoni Nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti) Użu għal ġol- vini
Single use injection.
Injezzjoni li tintuża darba biss.
Lot Pot.
Lott Qawwa.
See front label (Lot, Exp., Pot.)
Ara t- tikketta ta ’ quddiem (Lott, JIS, Qawwa.)
Store in a refrigerator (2-8 ºC).
Aħżen fi friġġ (2ºC - 8ºC).
83 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
82 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SOLVENT LABEL
TIKKETTA TAS- SOLVENT
For reconstitution of the accompanying BeneFIX 250 IU or 500 IU powder for solution for injection.
Għar- rikostituzzjoni tat- trab BeneFIX 250 IU jew 500 IU għal soluzzjoni għall- injezzjoni li jinsab miegħu.
5 ml single use vial.
Kunjett ta ’ 5 ml li jintuża darba.
Use the entire contents.
Uża l- kontenuti kollha.
84 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
83 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BeneFIX 500 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX)
BeneFIX 500 IU trab u solvent għal soluzzjoni għall- injezzjoni Nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti)
Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX).
Kull kunjett nominalment ikun fih 500 IU nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti).
After reconstitution with the accompanying 5 ml water for injection, each ml of the solution contains approximately 100 IU/ ml nonacog alfa.
Wara r- rikostituzzjoni bil- 5 ml ta ’ ilma għall- injezzjonijiet ipprovdut, kull ml ta ’ soluzzjoni jkun fih madwar 100 IU nonacog alfa.
Sucrose, Glycine, L-histidine, Polysorbate 80 and Water for Injections
Sucrose, Glycine, L- histidine, Polysorbate 80 u Ilma għall- injezzjonijiet
One vial with powder for solution for injection contains nonacog alfa 500 IU and excipients One vial of 5 ml water for injections One double-ended needle One filter spike One mini sterile infusion set
Kunjett wieħed bit- trab għal soluzzjoni għall- injezzjoni fih nonacog alfa 500 IU u sustanzi mhux attivi Kunjett wieħed ta ’ 5 ml ilma għall- injezzjonijiet Labra b’ żewġ trufijiet Labra rqiqa tal- filtru Mini- sett sterili wieħed ta ’ l- infużjoni Siringa sterilizzata li tintrema wara li tintuża ta ’ 10 ml għat- teħid Żewġ msiħ bl- alkoħol Żewġ biċċiet
87 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
85 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
BeneFIX 500 IU powder for solution for injection Nonacog alfa (recombinant coagulation factor IX) Intravenous use
BeneFIX 500 IU trab għal soluzzjoni għall- injezzjoni Nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti) Użu għal ġol- vini
See front label (Lot, Exp., Pot.)
Ara t- tikketta ta ’ quddiem (Lot, JIS, Qawwa.)
Store in a refrigerator (2-8 ºC)
Aħżen fi friġġ (2ºC - 8 ºC).
88 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
86 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
5 ml single use vial.
Kunjett ta ’ 5 ml li tintuża darba.
89 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
87 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BeneFIX 1000 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX)
BeneFIX 1000 IU trab u solvent għal soluzzjoni għall- injezzjoni Nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti)
Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX).
Kull kunjett nominalment ikun fih 1000 IU nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti).
After reconstitution with the accompanying 10 ml water for injection, each ml of the solution contains approximately 100 IU/ ml nonacog alfa.
Wara r- rikostituzzjoni bl- 10 ml ta ’ ilma għall- injezzjonijiet ipprovdut, kull 1 ml ta ’ soluzzjoni jkun fih madwar 100 IU nonacog alfa.
One vial of 10 ml water for injections One double-ended needle One filter spike One mini sterile infusion set One 10 ml sterile disposable syringe for administration Two alcohol swabs Two plasters
Kunjett wieħed bit- trab għal soluzzjoni għall- injezzjoni fih nonacog alfa 1000 IU u sustanzi mhux attivi Kunjett wieħed ta ’ 10 ml ilma għall- injezzjonijiet Labra b’ żewġ trufijiet Labra rqiqa tal- filtru Mini- sett sterili wieħed ta ’ l- infużjoni Siringa sterilizzata li tintrema wara li tintuża ta ’ 10 ml għat- teħid Żewġ msiħ bl- alkoħol Żewġ biċċiet
90 EXP {MM/ YYYY}
JIS {XX/ SSSS}
Use immediately or within 3 hours of reconstitution
Uża immedjatament jew fi żmien 3 sigħat mir- rikostituzzjoni.
91 92 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
89 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
BeneFIX 1000 IU powder for solution for injection Nonacog alfa (recombinant coagulation factor IX) Intravenous use
BeneFIX 1000 IU trab għal soluzzjoni għall- injezzjoni Nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti) Użu għal ġol- vini
Pot:
Lott Qawwa.
93 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
90 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
For reconstitution of the accompanying BeneFIX 1000 IU powder for solution for injection.
Għar- rikostituzzjoni tat- trab BeneFIX 1000 IU għal soluzzjoni għall- injezzjoni li jinsab miegħu.
10 ml single use vial.
Kunjett ta ’ 10 ml li tintuża darba.
Lot Wyeth Europa Ltd
Lott Wyeth Europa Ltd
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
91 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX).
Kull kunjett nominalment fih 250 IU nonacog alfa (fattur IX rikombinanti tal- koagulazzjoni).
After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 50 IU nonacog alfa.
Wara r - rikostituzzjoni bis- soluzzjoni għall- injezzjoni ta ’ 5 ml (0. 234%) sodium chloride li hi pprovduta miegħu, kull 1 ml ta ’ soluzzjoni jkun fih madwar 50 IU nonacog alfa.
Sucrose, Glycine, L-histidine, sodium chloride and Polysorbate 80.
Sucrose, Glycine, L- histidine, sodium chloride u Polysorbate 80
One vial with powder for solution for injection contains nonacog alfa 250 IU and excipients.
Kunjett wieħed bi trab għal soluzzjoni għall- injezzjoni fih nonacog alfa 250 IU u sustanzi mhux attivi.
One pre-filled syringe of solvent, 5 ml sterile 0.234% sodium chloride solution for injection for reconstitution, with one plunger rod One sterile vial adapter reconstitution device One sterile infusion set Two alcohol swabs One plaster One gauze pad
Siringa mimlija għal- lest bis- solvent, 5 ml ta '0. 234% sodium chloride soluzzjoni sterili għall - injezzjoni għar- rikostituzzjoni, b' lasta tal- planġer waħda Adapter sterili tal- kunjett tat- tagħmir tar- rikostituzzjoni Sett sterili ta ’ l- infużjoni Żewġ biċċiet bl- alkoħol Stikka waħda Pad wieħed tal- garża
Use only the pre-filled syringe of solvent provided in the box for reconstitution.
Uża s- siringa mimlija għal- lest tas- solvent biss, ipprovduta fil- kaxxa għar- rikostituzzjoni.
In order to prevent damage to the prefilled syringe, do not freeze it.
Biex ma ssirx ħsara lis- siringa mimlija għal- lest, tagħmilhiex fil- friża.
97 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
93 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
TRAY LID
GĦATU TAT- TRAY
BeneFIX 250 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX)
Nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti)
Single use injection.
Injezzjoni li tintuża darba biss
Read the Package Leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
98 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
94 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Store in a refrigerator (2-8 ºC).
Aħżen fi friġġ (2ºC – 8ºC).
99 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
95 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SOLVENT SYRINGE LABEL
TIKKETTA TAS- SIRINGA TAS- SOLVENT
Solvent for BeneFIX
Solvent għal BeneFIX
Contains 5 ml of 0.234% sodium chloride solution for injection
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI
100 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
96 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX).
Kull kunjett nominalment fih 500 IU ta 'nonacog alfa (fattur IX rikombinanti tal- koagulazzjoni).
One vial with powder for solution for injection contains nonacog alfa 500 IU and excipients.
Kunjett wieħed bi trab għal soluzzjoni għall- injezzjoni fih nonacog alfa 500 IU u sustanzi mhux attivi.
103 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
98 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
OTHER
NUMRU TAL- LOTT
Read the Package Leaflet before use
Aqra l- fuljett ta 'tagħrif qabel l- użu.
104 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
99 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Store in a refrigerator (2-8 ºC).
Aħżen fi friġġ (2º – 8ºC).
105 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
100 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
101 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX).
Kull kunjett nominalment fih 1000 IU nonacog alfa (fattur IX rikombinanti tal- koagulazzjoni).
After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 200 IU nonacog alfa
Wara r - rikostituzzjoni bis- soluzzjoni għall- injezzjoni ta '5 ml (0. 234%) sodium chloride li hi pprovduta miegħu, kull 1 ml ta' soluzzjoni jkun fih madwar 200 IU ta 'nonacog alfa.
One vial with powder for solution for injection contains nonacog alfa 1000 IU and excipients..
Kunjett wieħed bi trab għal soluzzjoni għall- injezzjoni fih nonacog alfa 1000 IU u sustanzi mhux attivi.
Use only the pre-filled syringe of solvent provided in the box for reconstitution.
Uża s- siringa mimlija għal- lest biss, ipprovduta fil- kaxxa għar- rikostituzzjoni.
109 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
103 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
MARKETING AUTHORISATION HOLDER
DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
110 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
104 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
111 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
105 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
112 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
106 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BeneFIX 2000 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX)
BeneFIX 2000 IU trab u solvent għal soluzzjoni għall- injezzjoni Nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti)
Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX).
Kull kunjett nominalment fih 2000 IU nonacog alfa (fattur IX rikombinanti tal- koagulazzjoni).
After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 400 IU nonacog alfa.
Wara r - rikostituzzjoni bis- soluzzjoni għall- injezzjoni ta '5 ml (0. 234%) sodium chloride li hi pprovduta miegħu, kull 1 ml ta' soluzzjoni jkun fih madwar 400 IU ta 'nonacog alfa.
One vial with powder for solution for injection contains nonacog alfa 2000 IU and excipients.
Kunjett wieħed bi trab għal soluzzjoni għall- injezzjoni fih nonacog alfa 2000 IU u sustanzi mhux attivi.
115 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
108 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
NAME OF MARKETING AUTHORISATION HOLDER
DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
116 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
109 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
BeneFIX 2000 IU powder for solution for injection Nonacog alfa (recombinant coagulation factor IX) Intravenous use
BeneFIX 2000 IU trab għal soluzzjoni għall- injezzjoni Nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti) Użu għal ġol- vini
117 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
110 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PACKAGE LEAFLET
111 FULJETT TA ’ TAGĦRIF
119 PACKAGE LEAFLET:
112 FULJETT TA ’ TAGĦRIF:
- If you have any further questions, ask your doctor or your pharmacist.
Jista ’ jkollok bżonn terġa ’ taqrah. − Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. − Din il- mediċina ġiet mogħtija lilek.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bhal tiegħek. − Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Before you take BeneFIX 3.
Qabel ma tieħu BeneFIX 3.
How to take BeneFIX 4.
Kif għandek tieħu BeneFIX 4.
How to store BeneFIX 6.
Kif taħżen BeneFIX 6.
WHAT BENEFIX IS AND WHAT IT IS USED FOR
X’ INHU BENEFIX U GĦALXIEX JINTUŻA
BeneFIX is a coagulation factor IX product that is produced by recombinant technology.
BeneFIX hu prodott tal- fattur IX tal- koagulazzjoni li hu magħmul bit- teknoloġija rikombinanti.
Patients with haemophilia B (Christmas disease) are deficient in coagulation factor IX.
Pazjenti bl- emofilja B (marda ta ’ Christmas) għandhom nuqqas tal- fattur IX tal- koagulazzjoni.
BeneFIX works by replacing factor IX in haemophilia B patients to enable their blood to clot.
BeneFIX jaħdem billi jintroduċi l- fattur IX f’ pazjenti li jbatu bl- emofilja B u b’ hekk jgħin biex id - demm tagħhom jagħqad.
BeneFIX is used for the treatment and prevention of bleeding (prophylaxis) in patients with haemophilia B (congenital factor IX deficiency).
BeneFIX jintuża għall- kura u l- prevenzjoni ta ’ telf ta ’ demm (profilassi) f’ pazjenti li jbatu bl- emofilja B (nuqqas konġenitali tal- fattur IX).
BEFORE YOU TAKE BENEFIX
QABEL MA TIEĦU BENEFIX
Do not take BeneFIX
Tieħux BeneFIX:
- If you are allergic (hypersensitive) to nonacog alfa or any of the other ingredients of BeneFIX.
− Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal nonacog alfa jew sustanzi oħra ta ’ BeneFIX. − Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- proteini tal- ħamsters.
Take special care with BeneFIX
Oqgħod attent ħafna b’ BeneFIX
- Activity-neutralizing antibodies (inhibitors) are an uncommon event in previously treated patients
− Kellem lit- tabib tiegħek immedjatament jekk il- fsada (telf ta ’ demm) ma tieqafx kif mistenni.
(PTPs) receiving factor IX-containing products.
− Antikorpi li jinnewtralizzaw l- attività (inibituri) huma avveniment mhux komuni f’ pazjenti li kienu ġew ikkurati qabel (PTPs) u li qed jirċievu prodotti li fihom il- fattur IX.
Since during clinical studies one PTP treated with BeneFIX developed a clinically relevant low responding inhibitor, and experience on antigenicity with recombinant factor IX is still limited, while being treated with BeneFIX you should be carefully monitored for the development of factor IX inhibitors.
Billi matul l - istudji kliniċi pazjent PTP wieħed li kien qed jieħu BeneFIX żviluppa impeditur klinikament relevanti ta rispons baxx u l- esperjenza dwar l- antiġeniċità mal- fattur IX rikombinanti għadha ristretta, meta inti tkun qiegħed tiġi kkurat b’ BeneFIX għandek tkun sorveljat b’ attenzjoni għall - iżvilupp ta ’ impedituri tal- fattur IX.
Sufficient data have not been obtained from ongoing clinical studies on the treatment of previously untreated patients (PUPs), with BeneFIX.
Ma ġietx miksuba informazzjoni suffiċjenti minn studji kliniċi li qed isiru bħalissa dwar il- kura ta ’ pazjentili ma kienux ikkurati (PUPs), b’ BeneFIX qabel.
- Clinical studies on BeneFIX did not determine whether patients aged 65 and over respond
− L- istudji kliniċi fuq BeneFIX ma stabilixxux jekk pazjenti li għandhom 65 sena jew aktar jirrispondux b’ mod differenti minn pazjenti iżgħar.
As for any patient receiving BeneFIX, if you are elderly your doctor will choose a specific dose appropriate for you.
Bħal fil- każ ta ’ kull pazjent li jirċievi BeneFIX, it- tabib tiegħek ser jagħżel doża speċifika adattata għalik.
The
113 − Bħal kull prodott ta ’ proteina li jittieħed ġol- vina, reazzjonijiet ta ’ sensittività eċċessiva tat- tip allerġiku huma possibli.
product may contain traces of hamster proteins.
Il- prodott jista ’ jkun fih traċċi ta ’ proteini tal- ħamsters.
Potentially life-threatening anaphylactic reactions have occurred with factor IX products, including BeneFIX.
Reazzjonijiet anafilattiċi li jistgħu jkunu ta ’ theddida għall- ħajja dehru bi prodotti tal- fattur IX, inkluż BeneFIX.
You will be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, itching, tightness of the chest, wheezing, low blood pressure and anaphylaxis (severe allergic reaction that can cause difficulty in swallowing and/ or breathing, red or swollen face and/ or hands).
Inti se tkun infurmat dwar sinjali bikrija ta ’ reazzjonijiet ta ’ sensittività eċċessiva li jinkludu diffikultà biex tieħu n- nifs, qtugħ ta ’ nifs, nefħa, urtikarja, ħakk, tagħfis tas- sider, tisfir man- nifs, pressjoni tad- demm baxxa u anafilassi (reazzjoni allerġika gravi li tista ’ toħloq diffikultà biex tibla ’ u/ jew tieħu n- nifs, wiċċ u/ jew idejn ħomor jew minfuħa).
- If allergic or anaphylactic-type reactions occur, stop the infusion immediately and contact a doctor
− Jekk jidhru reazzjonijiet allerġiċi jew li jixbhu lill- anafilassi, waqqaf l- infużjoni immedjatament u kkuntattja lit- tabib jew fittex kura medika ta ’ emerġenza immedjatament.
In case of severe allergic reactions, alternative therapy should be considered.
Fil- każ ta ’ reazzjonijiet ta ’ allerġija serja, terapija alternattiva għandha tkun ikkunsidrata.
- There have been reports in the literature showing a correlation between the occurrence of a factor IX
− Kien hemm rapporti li wrew korrelazzjoni bejn in- numru ta ’ każijiet ta ’ impeditur tal- fattur IX u r- reazzjonijiet allerġiċi.
Therefore, if you experience allergic reactions such as difficulty breathing, shortness of breath, swelling, hives, itching, tightness of the chest, wheezing, or hypotension, you should be evaluated for the presence of an inhibitor.
Għalhekk, jekk tħoss xi reazzjonijiet allerġiċi bħal ma huma diffikultà biex tieħu n- nifs, qtugħ ta ’ nifs, nefħa, urtikarja, ħakk, tagħfis tas- sider, tisfir man- nifs, jew pressjoni baxxa, inti għandek tiġi eżaminat għall- preżenza ta ’ impeditur.
It should be noted that patients with factor IX inhibitor may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Wieħed għandu jkun jaf li pazjenti b’ impeditur tal- fattur IX jistgħu jkunu f’ riskju ogħla ta ’ anafilassi meta jieħdu l - fattur IX.
Patients who have major
− Il- produzzjoni ta ’ fattur IX fil- ġisem hi kkontrollata mill- ġene ta ’ fattur IX.
deletion mutations of their factor IX gene may be more likely to have factor IX inhibitor and an allergic reaction.
Pazjenti li għandhom mutazzjonijiet maġġuri ta ’ tħassir fil- ġeni tagħhom ta ’ fattur IX, jistgħu jkunu iktar suxxettibbli li jkollhom inibitur ta ’ fattur IX u reazzjoni allerġika.
Therefore if you are known to have a major deletion mutation of the factor IX gene, your doctor will monitor you more closely for signs of an allergic reaction particularly when you first start to take BeneFIX.
Għalhekk, jekk hu magħruf li int għandek mutazzjoni maġġuri ta ’ tħassir fil- ġeni ta ’ fattur IX, it- tabib tiegħek ser jimmonitorjak mill- qrib għal sinjali ta ’ reazzjoni allerġika, b’ mod partikulari meta tibda tieħu BeneFIX.
factor IX should, according to the treating physician’ s judgement, be performed under medical observation where proper medical care for allergic reactions can be provided.
− Minħabba r- riskju ta ’ reazzjonijiet allerġiċi ma ’ konċentrati tal- fattur IX, l- għoti inizjali tal - fattur IX għandu, skond il- parir tat- tabib li qiegħedjikkurak, isir taħt sorveljanza medika fejn tkun tista ’ tingħata kura medika xierqa għar- reazzjonijiet allerġiċi
- Even in the absence of factor IX inhibitor, higher doses of BeneFIX may be needed than required
− Anke fin- nuqqas ta ’ impeditur għall- fattur IX, jista ’ jkun hemm bżonn dożi ta ’ BeneFIX akbar minn dawk tal- fattur IX derivat mill- plażma.
Therefore, close monitoring of factor IX plasma activity and pharmacokinetic assessment have to be performed in order to adjust doses as appropriate.
Għalhekk, għandu jsir monitoraġġ mill- qrib ta ’ l - attività tal- fattur IX fil- plażma u għandha ssir stima farmakokinetika sabiex d- dożi jiġu aġġustati kif jixraq.
If bleeding is not controlled with the recommended dose, contact your doctor.
Jekk il- fsada ma tiġix ikkontrollata bid- doża rakkomandata, għarraf lit- tabib tiegħek.
- If you suffer from a liver or cardiac disease or if you have recently had surgery, there is an increased
− Jekk tbati minn mard tal- fwied jew mard tal- qalb jew jekk għamilt xi operazzjoni riċentement, hemm riskju ogħla ta ’ kumplikazzjonijiet għal koagulazzjoni.
administration of BeneFIX.
− Kien hemm rapporti ta ’ tagħqid taċ- ċelluli l- ħomor tad- demm fit- tubu/ siringa bl- għoti ta ’ BeneFIX.
So far, no clinical sequelae have been reported in association with this observation.
S’ issa, ma ġewx rrapurtati kumplikazzjonijiet kliniċi assoċjati ma ’ din l - osservazzjoni.
To minimize the possibility of agglutination, it is important to limit the amount of blood entering the tubing.
Biex il- possibbiltà ta ’ agglutinazzjoni tkun imminimizzata, hu importanti li tillimita l- ammont ta ’ demm li jidħol fit- tubi.
If agglutination of red blood cells in the tubing/ syringe is observed, discard all this material (tubing, syringe and BeneFIX solution) and resume administration with a new package.
Jekk ikun hemm tagħqid taċ- ċelluli l- ħomor tad- demm fit- tubu/ siringa, armi l- apparat kollu (tubi, siringa u s- soluzzjoni BeneFIX) u kompli t- teħid minn pakkett ġdid.
Factor IX to induce immune tolerance in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
− Kien hemm rapporti ta ’ problemi fil- kliewi (sindromu nefrotiku) wara li ttieħdu dożi għolja ta ’ Fattur IX derivat mill- plażma, biex jikkaġunaw tolleranza immuni f’ pazjenti bl- emofilja B għall- impeditur għall- fattur IX u li kellhom reazzjonijiet allerġiċi fil- passat.
- It is recommended that, whenever possible, every time you use BeneFIX, the name and batch
− Hu rakkomandat li, kull meta jkun possibli, kull darba li inti tieħu BeneFIX, l- isem u n- numru tal- lott tal- prodott jiġu rrekordjati.
121 Taking other medicines:
114 Meta tuża mediċini oħra:
If you are pregnant or breast-feeding you should only take BeneFIX upon specific instructions from your physician.
Jekk inti tqila jew qegħda tredda ’ inti għandek tieħu BeneFIX biss wara struzzjonijiet speċifiċi tat - tabib tiegħek.
It is not known whether BeneFIX can affect reproductive capacity or cause foetal harm when given to pregnant women.
Mhux magħruf jekk BeneFIX jistax jaffettwa r- riproduzzjoni jew jikkawżax ħsara lill - fetu meta mogħti lil nisa tqal.
Your doctor may advise you to stop treatment with BeneFIX if you are breast- feeding or become pregnant.
It- tabib tiegħek jista ’ jagħtik il- parir li twaqqaf il- kura b’ BeneFIX jekk inti qegħda tredda ’ jew tinqabad tqila.
HOW TO TAKE BENEFIX
KIF GĦANDEK TIEĦU BENEFIX
Always take BeneFIX exactly as your doctor has instructed you.
Dejjem għandek tieħu BeneFIX skond il- parir tat- tabib.
Your doctor will decide the dose of BeneFIX you will receive.
It- tabib tiegħek jiddeċiedi d- doża ta ’ BeneFIX li inti se tieħu.
This dose and duration will depend upon your individual needs for replacement factor IX therapy and upon pharmacokinetics (recovery and half- life) that have to be checked regularly.
Id- doża u t- tul ta ’ żmien se jiddependu fuq il- bżonnijiet individwali tiegħek għat- terapija ta ’ sostituzzjoni tal- fattur IX u fuq il - farmakokinetiċi (fejqan u żmien kemm idum biex jonqos bin- nofs) li għandhom jiġu vverfikati regolarment.
You may notice a difference in the dose you receive if you are changing from a plasma-derived factor IX product to BeneFIX.
Tista ’ tinnota differenza fid- doża li tirċievi jekk qed tibdel minn fattur IX derivat mill - plażma għal BeneFIX.
Your doctor may decide to change the dose of BeneFIX you receive during your treatment.
It- tabib tiegħek jista ’ jiddeċiedi li matul il- kura, jibdillek id- doża ta ’ BeneFIX li qed tieħu.
The procedures below are provided as guidelines for the reconstitution and administration of BeneFIX.
Il- proċeduri ta ’ hawn taħt qed jingħataw bħala għajnuna għar- rikostituzzjoni u l- għoti ta ’ BeneFIX.
Patients should follow the specific venipuncture procedures provided by their physicians.
Il - pazjenti għandhom isegwu il- proċeduri speċifiċi ta ’ titqib ġol- vina pprovduti mit- tobba tagħhom.
Always wash your hands prior to performing the following procedures.
Dejjem aħsel idejk qabel ma tibda dawn il- proċeduri li ġejjin.
Aseptic technique (meaning clean and germ free) should be used during the reconstitution procedure.
Waqt il- proċedura ta ’ rikostituzzjoni, għandha tintuża teknika asettika (jiġifieri nadifa u mingħajr mikrobi).
BeneFIX will be administered by intravenous infusion (IV) after reconstitution with sterile water for injections (solvent).
BeneFIX se jingħata permezz ta ’ infużjoni ġol- vina (IV) wara rikostituzzjoni b’ ilma sterilizzat għall - injezzjonijiet (solvent).
Allow the lyophilised vial of BeneFIX and solvent to reach room temperature.
Ħalli li l- kunjett lifolizzata ta ’ BeneFIX u s- solvent jilħqu t- temperatura tal- kamra.
Remove the caps from the BeneFIX concentrate and solvent vials, to expose the central portion of the rubber stoppers.
Neħħi l- għatu mill- fjali tal- konċentrat u tas- solvent ta ’ BeneFIX, sabiex tesponi l- parti ċentrali tat- tappijiet tal- gomma.
Wipe the tops of both vials with an alcohol swab provided, or use another antiseptic solution and allow to dry.
Imsaħ il- parti ta ’ fuq taż- żewġ fjali bit- tajjara mxappa bl- alkoħol mogħtija, jew uża soluzzjoni antisettika oħra u ħallihom jinxfu.
Remove the transparent protective cover from the short end of the sterile double-ended needle, and insert that end of the needle into the solvent vial at the centre of the stopper.
Neħħi l- għatu trasparenti protettiv minn naħa l- qasira tal- labra sterilizzata b’ żewġ trufijiet, u daħħal it- tarf tal- labra fil- kunjett tas- solvent fin- nofs tat- tapp.
Note: solvent vial should be positioned on a flat level surface such as a table and needle inserted vertically, i. e. perpendicular to the stopper surface.
Nota: il- kunjett tas- solvent għandha titpoġġa fuq wiċċ lixx, bħal mejda, u l- labra tiddaħħal b’ mod vertikali; i. e. b’ mod perpendikulari mal- wiċċ tat- tapp.
Remove the coloured protective cover from the long end of the sterile double ended needle.
Neħħi l- għatu protettiv kkulurit minn naħa t- twila tal- labra b’ żewġ trufijiet sterilizzata.
Invert the solvent vial and, to minimise leakage, quickly insert the long end of the needle through the centre of the stopper of the upright BeneFIX vial.
Aqleb il - kunjett tas- solvent, u sabiex tnaqqas it- telf, daħħal malajr in- naħa t- twila tal- labra fin- nofs tat - tapp tal- kunjett wieqfa ta ’ BeneFIX.
BeneFIX vial should be positioned on a flat level surface such as a table and long end of the needle inserted vertically, i. e. perpendicular to the stopper surface.
Il- kunjett b’ BeneFIX għandha titpoġġa fuq wiċċ lixx, bħal mejda, u t- tarf twil tal- labra jiddaħħal b’ mod vertikali; i. e. b’ mod perpendikulari mal - wiċċ tat- tapp.
See Fig.1.
Ara l- istampa numru 1.
The vacuum will draw the solvent into the BeneFIX vial.
Il- vakwu jiġbed is- solvent fil- kunjett ta ’ BeneFIX.
While the solvent is being drawn into the BeneFIX vial, point the double-ended needle toward the wall of the BeneFIX vial to prevent excess foaming.
Waqt li s- solvent ikun qed jinġibed ġol- kunjett ta ’ BeneFIX, ipponta l- labra b’ żewgt itruf lejn il - ħajt tal- kunjett ta ’ BeneFIX biex tevita ragħwa eċċessiva.
Once the transfer is complete, remove the long end of the needle from the BeneFIX vial, and properly discard the needle with the empty solvent vial.
Meta t- trasferiment ikun komplut, neħħi n- naħa t- twila tal- labra mill- kunjett ta ’ BeneFIX, u armi kif xieraq l- labra flimkien mal- kunjett tas- solvent vojta.
If the solvent does not completely transfer into the BeneFIX vial, DO NOT USE the contents of the vial.
Jekk is- solvent ma jinġibidx għal kollox għal ġol- kunjett ta ’ BeneFIX, TUŻAX il- kontenut tal - kunjett.
Note that it is acceptable for a small amount of fluid to remain in the solvent vial after transfer.
Kun af li hu aċċettabli li ammont żgħir ta ’ likwidu jibqa ’ fil- kunjett tas- solvent wara t - trasferiment.
Gently rotate the vial to dissolve the powder.
Dawwar bil- mod il- kunjett sabiex jinħall it- trab.
2.
Ara l- istampa numru 2.
The final solution should be inspected visually for particulate matter before administration.
Is- soluzzjoni finali għandha tiġi eżaminata għal xi frak qabel ma tittieħed.
The solution should appear clear and colourless.
Is- soluzzjoni għandha tkun ċara u mingħajr kulur.
BeneFIX should be administered immediately or within 3 hours after reconstitution.
BeneFIX għandu jintuża immedjatament jew fi żmien tliet sigħat wara r- rikostituzzjoni.
The reconstituted solution may be stored at room temperature prior to administration.
Is- soluzzjoni rikostitwita tista ’ tinħażen f’ temperatura tal- kamra qabel ma tittieħed.
Administration (Intravenous Injection):
Teħid (Injezzjoni għal ġol- vina)
BeneFIX should be administered using a single sterile plastic disposable syringe.
BeneFIX għandu jittieħed bl- użu ta ’ siringa tal- plastik sterilizzata li tintrema wara li tintuża.
In addition, the solution should be withdrawn from the vial using the filter spike.
Barra minn hekk, is- soluzzjoni għandha tinġibed mill- kunjett bl- użu ta ’ labra rqiqa tal- filtru.
Using aseptic technique, attach the filter spike to the sterile disposable syringe.
Bl- użu tat- teknika asettika, waħħal il- labra rqiqa tal- filtru mas- siringa sterilizzata li tintrema wara li tintuża.
DO NOT push air into the BeneFIX vial.
TIMBUTTAX arja fil- kunjett ta ’ BeneFIX.
This may cause partial loss of product.
Dan jista ’ joħloq telf parzjali tal- prodott.
Insert the filter spike end into the stopper of the BeneFIX vial.
Daħħal it- tarf tal- labra rqiqa tal- filtru fit- tapp tal- kunjett ta ’ BeneFIX.
See Fig.3.
Ara stampa numru 3.
Invert the vial and withdraw the reconstituted solution into the syringe.
Aqleb il- kunjett u iġbed is- soluzzjoni għal ġos- siringa.
See Fig.4.
Ara stampa numru 4.
Remove and discard the filter spike.
Neħħi u armi l- labra rqiqa tal- filtru.
If you are to receive more than one vial of BeneFIX the contents of multiple vials may be drawn into the same syringe through a separate, unused filter spike.
Jekk tkun se tieħu aktar minn kunjett wieħed ta ’ BeneFIX il- kontenut ta ’ diversi fjali jista ’ jinġibed għal ġo l- istess siringa permezz ta ’ labra rqiqa tal- filtru separata u mhux użata.
Attach the syringe to the adaptor (Luer) end of the infusion set.
5.
Transfer BeneFIX solution into the tubing by depressing the syringe plunger until the tubing is filled completely.
Ittrasferixxi s- soluzzjoni BeneFIX għal ġot- tubu billi tiġbed il- planġer tas- siringa `l fuq sakemm it- tubu jkun mimli għal kollox.
During venipuncture, it is important to adhere to the instructions to limit the amount of blood entering the tubing.
Matul it- titqiba fil- vina, hu importanti li timxi ma ’ l- istruzzjonijiet sabiex tillimita l- ammont ta ’ demm li jidħol fit- tubi.
Blood must not enter the syringe.
Id- demm m’ għandux jidħol fis- siringa.
Perform venipuncture as instructed by your physician.
Għamel it- titqiba ġol- vina kif indikat mit- tabib tiegħek.