qanastek/EMEA-V3 huggingface dataset:
Dosing of BeneFIX may differ from that of plasma-derived factor IX products.
Id- dożaġġ ta ’ BeneFIX jista ’ jkun differenti minn dak ta ’ prodotti ta ’ Fattur IX derivati mill- plażma.
To ensure that the desired factor IX activity level has been achieved, precise monitoring using the factor IX activity assay is advised and doses should be calculated taking the factor IX activity, pharmacokinetic
Sabiex jiġi żgurat li jintlaħaq l- livell mixtieq ta ’ attività tal- fattur IX, hu rakkomandat li ssir analiżi preċiża permezz ta ’ l- assay ta ’ l- attività tal- fattur IX u d- dożi għandhom ikunu kkalkulati billi jiġu kkunsidrati l- attività tal- fattur IX, il- parametri farmakokinetiċi bħal half- life u l- irkupru tal- pazjent, kif ukoll is- sitwazzjoni klinika sabiex id- doża tiġi mibdula kif jixraq.
2 parameters such as half-life and recovery, as well as the clinical situation into consideration in order to adjust the dose as appropriate.
2 L- ammont li għandu jingħata u kull kemm għandu jingħata għandhom dejjem jitqiesu skond l - effettività klinika fil- każ individwali.
Factor IX products rarely require to be administered more than once daily.
Prodotti tal- fattur IX ikollhom bżonn jingħataw aktar minn darba kuljum, f’ każijiet rari.
The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
In- numru ta ’ unitajiet tal- fattur IX mogħtija jitfissru f’ Unitajiet Internazzjonali (IU), li huma marbuta ma ’ l- istandard attwali ta ’ l- Organiżżazzjoni Dinjina tas- Saħħa għall- prodotti tal- fattur IX.
Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an international standard for factor IX in plasma).
L- attività tal- fattur IX fil- plażma jitfisser bħala persentaġġ (relattiv mal- plażma tal- bniedem) jew bħala Unitajiet Internazzjonali (marbuta ma ’ l- istandard internazzjonali għall- fattur IX fil- plażma).
One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.
Unità Internazzjonali waħda (IU) ta ’ l- attività tal- fattur IX hija ekwivalenti għall- kwantità ta ’ fattur IX f’ millilitru tal- plażma ta ’ bniedem normali.
Estimation of the required dose of BeneFIX can be based on the finding that one unit of factor IX activity per kg body weight is expected to increase the circulating level of factor IX, an average of 0.8 IU/ dl (range from 0.4 to 1.4 IU/ dl) in adult patients (≥ 15 years).
Stima tad- doża meħtieġa ta ’ BeneFIX tista ’ tkun ibbażata fuq il- fatt li unità waħda ta ’ attività ta ’ fattur IX għal kull kg tal- piż tal- ġisem hi mistennija li żżid il - livell ta ’ ċirkolazzjoni tal- fattur IX, b’ medja ta ’ 0. 8 IU/ dl (minn 0. 4 sa 1. 4 IU/ dl) f’ pazjenti adulti (≥ 15- il sena).
Pharmacokinetics have to be assessed regularly in each patient and posology has to be adjusted accordingly.
Il- farmakokinetiċi għandhom ikunu analizzati regolarment f’ kull pazjent u l- pożoloġija għandha tinbidel skond ir- riżultati miksuba.
The required dosage is determined using the following formula:
Id- doża meħtieġa hi stabbilita bl- użu tal- formula li ġejja:
Number of factor IX IU required
Numru ta ’ IU ta ’ fattur IX meħtieġa
body weight (in kg)
piż tal- ġisem (f’ kg)
desired factor IX X increase (%) or (IU/ dl)
żjieda ta ’ fattur IX X mixtieqa (%) jew (IU/ dl)
reciprocal of observed recovery
ir- reċiproku tal - fejqan osservat
For a recovery 0.7 IU/ dl (average increase of factor IX), then:
Għal irkupru 0. 7IU/ dl (żjieda medja ta ’ fattur IX), imbagħad:
1.4 IU/ kg
1. 4 IU/ kg
In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity levels (in% of normal or in IU/ dl) in the corresponding period.
Fil- każijiet ta ’ emorraġija li ġejjin, l- attività ta ’ fattur IX m’ għandiex taqa ’ taħt il- livelli ta ’ attività ta ’ plażma mogħtija hawn taħt (f ’% tan- normal jew f’ IU/ dl) fil- perijodu korrispondenti.
The following table can be used to guide dosing in bleeding episodes and surgery:
It- tabella li ġejja tista ’ tintuża sabiex tagħti ndikazzjoni tad- dożaġġ meħtieġ f’ każi ta ’ telf ta ’ demm u kirurġija:
Degree of haemorrhage/ Type of surgical procedure Haemorrhage
3 Grad ta ’ emorraġija/ Tip ta ’ proċedura kirurġika Emorraġija
Factor IX level required (%) or (IU/ dl)
Fattur IX mixtieq (%) jew (IU/ dl)
Frequency of doses (hours)/ Duration of Therapy (days)
Frekwenza ta ’ dożi (siegħat) / Tul tat - Terapija (ġranet)
Early haemarthrosis, muscle bleeding or oral bleeding
Emartrożi bikrija, fsada mill - muskoli jew mill- ħalq
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Tindina b’ dan mill - uġigħ li tkun qed tħoss.
More extensive haemarthrosis, muscle bleeding or haematoma
Emartrożi aktar estensiva, telf ta ’ demm mill- muskoli jew ematoma
Repeat infusion every 24 hours for 3- 4 days or more until pain and acute disability are resolved.
Irrepeti l- infużjoni kull 24 siegħa għal 3- 4 ijiem jew aktar sakemm l- uġigħ u d- diżabilità akuta jgħaddi.
Life-threatening haemorrhages
Emorraġiji li jkunu ta ’ theddida għall- ħajja Kirurġija
Repeat infusion every 8 to 24 hours until threat is resolved.
Irrepeti l- infużjoni kull 8 sigħat għal 24 siegħa sakemm ma tibqax fil - periklu.
Minor:
30- 60 Minuri:
Including tooth extraction
Inkluż qlugħ tas- snien
Every 24 hours, at least 1 day, until healing is achieved.
Kull 24 siegħa, mill- anqas għal ġurnata, sakemm tfiq.
(pre- and
Maġġuri:
until adequate wound healing, then
Irrepeti l- infużjoni kull 8 sigħat għal
postoperative)
(qabel u wara l - operazzjoni)
therapy for at least another 7 days to maintain a factor IX activity of 30% to 60% (IU/ dl)
24 siegħa sakemm jinkiseb fejqan adegwat tal- ferita, imbagħad t- terapija titkompla għal mill- anqas 7 ijiem oħra sabiex tinżamm l- attività tal- fattur IX ta ’ 30% sa ’ 60% (IU/ dl)
During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Waqt il- kors tal- kura, hu rakkomandat li jiġu stabbiliti l- livelli tal- fattur IX bħala gwida tad- doża li għandha tingħata u l- frekwenza ta ’ l- infużjonijiet ripetuti.
In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Fil- każ ta ’ interventi kirurġiċi maġġuri b’ mod partikolari, hu indispensabbli li ssir analiżi preċiża tat- terapija ta ’ sostituzzjoni permezz ta ’ l - analiżi tal- koagulazzjoni (attività tal- fattur IX fil- plażma).
Individual patients may vary in their response to factor IX, achieving different levels of in vivo recovery and demonstrating different half-lives.
Il- pazjenti jistgħu ma jkullhomx l- istess rispons għall- fattur IX għalhekk jinkisbu livelli differenti ta ’ rkupru in vivo u half- lives differenti.
For long term prophylaxis against bleeding in patients with severe haemophilia B, BeneFIX may be administered.
BeneFIX jista ’ jingħata lill- pazjenti li jbatu b’ emofilja B severa, bħala profilassi, għal żmien twil.
In a clinical study for routine secondary prophylaxis the average dose for previously treated patients (PTP) was 40 IU/ kg (range 13 to 78 IU/ kg) at intervals of 3 to 4 days.
Fi studju kliniku għal profilassi sekondarja, id- doża medja għal pazjenti li kienu ġew ikkurati qabel (PTP) kienet ta ’ 40 IU/ kg (medda minn 13 sa 78 IU/ kg) f’ intervalli ta ’ 3 sa 4 ijiem ta ’ rutina.
In younger patients, shorter dosage intervals or higher doses may be necessary.
F’ pazjenti iżgħar, jista ’ jkun hemm bżonn intervalli iqsar bejn id- dożi jew dożi akbar.
There are insufficient data to recommend the use of BeneFIX in children less than 6 years of age.
M’ hemmx informazzjoni biżżejjed biex jiġi rakkomandat l- użu ta ’ BeneFIX f’ pazjenti ta’ età iżgħar minn 6 snin.
In clinical studies, 57% of the paediatric patients increased their doses due to lower than expected recovery or to obtain sufficient therapeutic response or both, some to an average dose of > 50 IU/ kg.
Fi studji kliniċi, 57% tal- pazjenti pedjatriċi żiedu d- dożi tagħhom għax kellhom rkupru anqas minn dak li kien mistenni jew sabiex jiksbu effett terapewtiku suffiċjenti jew minħabba t- tnejn li huma.
Therefore, close monitoring of factor IX plasma activity should be performed, as well as calculation of pharmacokinetic parameters such as recovery and half-life, as clinically indicated, in order to adjust doses as appropriate.
Għalhekk, wieħed għandu jeżamina mill- qrib l- attività tal- fattur IX, fil- plażma u jridu jsiru kalkoli tal- parametri farmakokinetiċi bħal ma huma l - irkupru u l- half- life, hekk kif inhu indikat klinikament, sabiex id- dożi jiġu mibdula kif meħtieġ.
If doses > 100 IU/ kg have been repeatedly needed during routine prophylaxis or treatment, a switch to another FIX product should be considered.
Jekk dożi > 100 IU/ kg kienu meħtieġa ripetutament għall- profilassi jew għal kura ta ’ rutina, wieħed irid jikkonsidra li jibdel il- prodott għal xi prodott FIX.
Patients should be monitored for the development of factor IX inhibitors.
Il- pazjenti għandhom jiġu sorveljati għall- iżvilupp ta ’ impeditur għall- fattur IX.
If the expected factor IX activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, biological testing should be performed to determine if a factor IX inhibitor is present.
Jekk il- livelli mistennija ta ’ l- attività tal- fattur IX fil- plażma ma ’ jinkisibx, jew jekk il- fsada ma tkunx ikkontrollata b’ doża xierqa, għandhom isiru testijiet bijoloġiċi sabiex jiġi stabbilit jekk hemmx xi impeditur tal - fattur IX.
In patients with high levels of inhibitor factor IX therapy may not be effective and other therapeutic options must be considered.
F’ pazjenti b’ livelli għoljin ta ’ impeditur għall- fattur IX it- terapija tista ’ ma tkunx effettiva u għandhom jiġu kkunsidrati għażliet terapewtiċi oħra.
Management of such patients should be directed by physicians with experience in the care of patients with haemophilia.
Dawn il- pazjenti għandhom ikunu qegħdin taħt is- sorveljanza ta ’ tobba b’ esperjenza fil- kura ta ’ pazjenti bl- emofilja.
In most of the cases, an infusion rate of up to 4 ml per minute has been used.
4 Metodu ta ’ kif għandu jingħata
The rate of administration should be determined by the patient’ s comfort level.
BeneFIX jingħata b’ infużjoni ġol- vina wara li t- trab ikun ġie rikostitwit għal soluzzjoni għal injezzjoni b’ ilma sterilizzat għall- injezzjoni (ara sezzjoni 6. 6).
4 4.3 Contraindications
Fil- maġġoranza tal- każi, rata ta ’ infużjoni sa ’ 4 ml kull minuta intużat.
Known allergic reaction to hamster proteins.
Reazzjoni allerġika magħrufa għal proteini tal- ħamsters.
Activity-neutralizing antibodies (inhibitors) are an uncommon event in previously treated patients (PTPs) receiving factor IX-containing products.
Anti- korpi li jinnewtralizzaw l- attività (impedituri) huma avveniment mhux komuni f’ pazjenti li kienu ġew ikkurati qabel (PTP’ s) 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, patients treated with BeneFIX should be carefully monitored for the development of factor IX inhibitors that should be titrated in Bethesda Units using appropriate biological testing.
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, il- pazjenti li jiġu kkurati b’ BeneFIX għandhom ikunu sorveljati b’ mod partikolari għall- iżvilupp ta ’ impedituri tal- fattur IX li għandhom ikunu ttitrati f’ Unitajiet Bethesda permezz ta ’ ttestjar bijoloġiku xieraq.
Sufficient data have not been obtained from ongoing clinical studies on the treatment of previously untreated patients (PUPs), with BeneFIX.
Ma ġietx miksuba biżżejjed informazzjoni minn studji kliniċi li qed isiru bħalissa dwar il- kura ta ’ pazjenti mhux trattati qabel (PUP’ s), b’ BeneFIX.
Additional safety and efficacy studies in paediatric patients are ongoing in previously treated, minimally treated, and previously untreated paediatric patients.
Studji addizzjonali dwar is- sigurtà u l- effiċjenza fuq pazjenti pedjatriċi huma għaddejjin kontinwament fuq pazjenti pedjatriċi trattati qabel, trattati minimament u dawk li mhux trattati qabel.
Clinical studies of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Studji kliniċi fuq BeneFIX ma kienux inkludew numru suffiċjenti ta ’ pazjenti ta ’ età ta ’ 65 sena jew aktar biex ikun determinat jekk jirrispondux b’ mod differenti minn pazjenti żgħażagħ.
As with any patient receiving BeneFIX, dose selection for an elderly patient should be individualised.
Bħal każ ta ’ kull pazjent li jirċievi BeneFIX, l- għażla tad- doża għall- pazjent anzjan għandha tkun individwalizzata.
As with any intravenous protein product, allergic-type hypersensitivity reactions are possible.
Bħal kull prodott ta ’ proteina li jingħata ġol- vini, reazzjonijiet ta ’ sensittività eċċessiva li jixbħu lill - allerġiji huma possibli.
The product contains traces of hamster proteins.
Il- prodott fiħ traċċi ta ’ proteini tal- ħamsters.
Potentially life-threatening anaphylactic/ anaphylactoid reactions have occurred with factor IX products, including BeneFIX.
Reazzjonijiet anafilattiċi/ anafilattojdi li huma ta ’ theddida għall- ħajja dehru bi prodotti tal- fattur IX, inkluż BeneFIX.
Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, itching, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Il- pazjenti għandhom ikunu infurmati dwar sinjali bikrija ta ’ reazzjonijiet ta ’ sensittività eċċessiva li jinkludu diffikultà biex tieħu n- nifs, qtugħ ta ’ nifs, nefħa, urtikarja, ħakk, tagħfis fis- sider, tisfir man- nifs, pressjoni baxxa, u anafilassi.
If allergic or anaphylactic-type reactions occur, the administration of BeneFIX has to be discontinued immediately and an appropriate treatment has to be initiated.
Jekk jidhru reazzjonijiet ta ’ allerġija jew ta ’ anafilassi, t- teħid ta ’ BeneFIX għandu jitwaqqaf immedjatament u għandha tinbeda l- kura xierqa.
In some cases, these reactions have progressed to severe anaphylaxis.
F’ xi każijiet, dawk ir- reazzjonijiet żviluppaw f’ anafilassi gravi.
In the case of shock, the current medical standards for treatment of shock should be observed.
Fil- każ ta ’ xokk, l- istandards mediċi attwali għall- kura ta ’ xokk għandhom jiġu osservati.
In case of severe allergic reactions, alternative haemostatic measures should be considered.
F’ każ ta ’ reazzjonijiet allerġiċi serji, miżuri alternattivi emostatiċi għandhom jiġu kkunsidrati.
There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Kien hemm rapporti li wrew korrelazzjoni bejn l- frekwenza ta ’ każijiet ta ’ impeditur għall- fattur IX u reazzjonijiet allerġiċi.
Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Għalhekk, pazjenti li jkollhom reazzjonijiet allerġiċi għandhom jiġu evalwati għall- preżenza ta ’ impeditur.
It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Huwa mportanti li tkun taf li pazjenti b’ impeditur tal- fattur IX jistgħu jkunu f’ riskju ogħla ta ’ anaflassi bi sfida sussegwenti mal- fattur IX.
Preliminary information suggests a relationship may exist between the presence of major deletion mutations in a patient's factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions.
Informazzjoni preliminari tissuġġerixxi li tista ’ teżisti relazzjoni bejn il- preżenza ta ’ mutazzjonijiet maġġuri ta ’ tħassir fil- ġeni ta ’ fattur IX ta ’ pazjent u r- riskju miżjud tal- formazzjoni ta ’ l- inibitur u ta ’ reazzjonijiet ta ’ sensittività eċċessiva.
Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product.
Pazjenti li hu magħruf li għandhom mutazzjonijiet maġġuri ta ’ tħassir fil- ġeni ta ’ fattur IX għandhom jiġu osservati mill- qrib għal sinjali ta ’ reazzjonijiet ta ’ sensittività eċċessiva akuta, b’ mod partikulari matul il- fażijiet bikrin ta ’ l- espożizzjoni inizjali għall- prodott.
Because of the risk of allergic reactions with factor IX concentrates, the initial administrations of factor IX should, according to the treating physician’ s judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
5 Minħabba r- riskju ta ’ reazzjonijiet allerġiċi għall- konċentrati ta ’ fattur IX, l- għoti inizjali ta ’ fattur IX għandu, skond il- parir tat- tabib li qiegħed jikkura, isir taħt sorveljanza medika fejn tkun tista ’ tingħata kura medika xierqa għal reazzjonijiet allerġiċi.
Posology has to be adjusted according to the pharmacokinetics of each patient.
Il- pożoloġija għandha tinbidel skond il- farmakokinetiċi ta ’ kull pazjent.
Although BeneFIX contains only factor IX, the risk of thrombosis and disseminated intravascular coagulation (DIC) should be recognised.
Għalkemm BeneFIX fih biss il- fattur IX, wieħed għandu jkun jaf bir- riskju ta ’ trombożi u koagulazzjoni intravaskulari mifruxa (DIC).
Because of the potential risk of thrombotic complications,
Billi l- użu ta ’ konċentrati kumplessi tal- fattur IX kien storikament assoċjat mal- kumplikazzjonijiet tromboembolitiċi, l- użu ta ’ prodotti li fihom il- fattur IX jista ’ jkun ta ’ periklu f’ pazjenti b’ sinjali ta ’ fibrinolożi u f’ pazjenti li għandhom koagulazzjoni intravaskulari mifruxa (DIC).
5 clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to neonates, or to patients at risk of thrombotic phenomena or DIC.
Minħabba r- riskju ta ’ kumplikazzjonijiet trombotiċi, huwa mportanti li jsir monitoraġġ kliniku għal sinjali bikrija tal- koagulopatija trombotika u konsumattiva u għandha ssir eżaminazzjoni bijoloġika xierqa meta jingħata dan il- prodott lil pazjenti b’ mard tal- fwied, pazjenti wara li jkunu għamlu xi operazzjoni, trabi tat- twelied, jew pazjenti li qiegħdin f’ riskju ta ’ fenomeni trombotiċi jew DIC.
In each of these situations, the benefit of treatment with BeneFIX should be weighed against the risk of these complications.
F’ kull waħda minn dawn is- sitwazzjonijiet, il- benefiċċju tal- kura b’ BeneFIX għandu jiġi mwieżen kontra r- riskju ta ’ dawn il- kumplikazzjonijiet.
There have been reports of agglutination of red blood cells in the tube/ syringe with the administration of BeneFIX.
Kien hemm rapporti ta ’ agglutinazzjoni 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 irrapurtati kumplikazzjonijiet assoċjati ma ’ din l- osservazzjoni.
To minimize the possibility of agglutination, it is important to limit the amount of blood entering the tubing.
Biex titnaqqas għall- minimu l- possibbiltà ta ’ agglutinazzjoni, hu importanti li tillimita l- ammont ta ’ demm li jidħol fit- tubi.
Blood should not enter the syringe.
Id- demm m’ għandux jidħol ġos- siringa.
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 tkun osservata agglutinazzjoni taċ - ċelluli l - ħomor tad- demm fit- tubu/ siringa, armi l- apparat kollu (tubi, siringa u s- soluzzjoni ta ’ BeneFIX) u kompli t- teħid minn pakkett ġdid.
Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with Factor IX inhibitors and a history of allergic reaction.
Sindromu nefrotiku kien rappurtat wara prova ta ’ żvilupp ta ’ tolleranza immuni f’ pazjenti bl- emofilija B b’ impedituri ta ’ fattur IX li kellhom reazzjoni allerġika fil- passat.
The safety and efficacy of using BeneFIX for immune tolerance induction has not been established.
Is- sigurtà u l- effikaċja ta ’ l- użu ta ’ BeneFIX għall- induzzjoni ta ’ tolleranza immuni għadhom ma ġewx stabbiliti.
In the interest of patients, it is recommended that, whenever possible, every time that BeneFIX is administered to them, the name and batch number of the product is registered.
Fl- interess tal- pazjenti, hu rakkomandat, li kull meta jkun possibli, kull darba li jingħatalhom BeneFIX, l- isem u n- numru tal- lott tal- prodott jiġu rreġistrati.
Animal reproduction studies have not been conducted with factor IX.
Ma sarux studji dwar l- effett tal- fattur IX fuq ir- riproduzzjoni ta ’ l- annimali.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breastfeeding is not available.
Msejsa fuq in- numru ta ’ każijiet rari ta ’ emofilja B fin- nisa, l- esperjenza rigward l- użu tal- fattur IX waqt it- tqala u l- irdigħ mhix disponibbli.
Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Għalhekk, il- fattur IX għandu jintuża matul it- tqala u t- treddigħ biss jekk ikun indikat b’ mod ċar.
To date, no adverse reactions reported in association with BeneFIX occurred with a frequency of ≥ 1/ 100 to < 1/ 10 (common).
Sa llum, l- ebda reazzjonijiet avversi li kienu rrappurtati b' rabta ma 'BeneFIX ma seħħew bi frekwenza ta' ≥ 1/ 100 sa < 1/ 10 (komuni).
The frequency of adverse reactions reported in association with BeneFIX would be categorized as uncommon (≥ 1/ 1000 to ≤ 1/ 100) or rare (≥ 1/ 10,000 to ≤ 1/ 1000).
Il- frekwenza ta 'reazzjonijiet avversi rrappurtati b’ rabta ma ’ BeneFIX jistgħu jiġu maqsuma f’ kategorija bħala mhux komuni (≥ 1/ 1000 sa ≤ 1/ 100) jew rari (≥ 1/ 10, 000 sa ≤ 1/ 1000).
Of these the most significant include: anaphylaxis, cellulitis, phlebitis, and neutralising antibodies.
Minn dawn, l- iktar sinifikanti jinkludu: anafilassi, ċellulite, flebite, u antikorpi li jinnewtralizzaw.
Adverse reactions based on experience from clinical trials and postmarketing experience are presented below by system organ class and frequency of occurrence.
Reazzjonijiet avversi bbażati fuq esperjenza minn provi kliniċi u esperjenza ta 'wara t- tqegħid fis- suq huma ppreżentati hawn taħt skond il- klassi ta' l- organu tas- sistema u l- frekwenza ta 'l- okkorrenza.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
6 F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
These frequencies have been estimated on a per- infusion basis and are described using the following categories: uncommon (≥ 1/ 1000 to ≤ 1/ 100); rare (≥ 1/ 10,000 to ≤ 1/ 1000).
Dawn il- frekwenzi ġew stmati fuq bażi ta ’ kull infużjoni u huma deskritti billi jintużaw il- kategoriji li ġejjin: mhux komuni (≥1/ 1000 sa ≤1/ 100); rari (≥1/ 10, 000 sa ≤1/ 1000).
Dizziness, headache, altered taste, lightheadedness
Sturdament, uġigħ ta ’ ras, tibdil fit- togħma, nuqqas ta ’ konċentrazzjoni
6 Gastrointestinal disorders
Disturbi gastro- intestinali
Nausea Vomiting
Tqallih Rimettar
General disorders and administration site conditions
kondizzjonijiet ta ’ mnejn jingħata
Cellulitis, phlebitis, injection site reaction (including burning infusion site and injection site stinging), injection site discomfort
Ċellulite, flebite, reazzjonijiet fejn issir l- injezzjoni (inkluż ħruq u tingiż fil- post ta ’ l- infużjoni), skumdità fil- post ġol- vina
Neutralising antibodies (factor IX inhibition)* Hypersensitivity/ allergic reactions; such reactions may include anaphylaxis*, bronchospasm/ respiratory distress, hypotension, angioedema, tachycardia, chest tightness, generalised urticarial, hives, rash, burning sensation in jaw and skull, chills (rigors), tingling, flushing, lethargy, restlessness, dry cough/ sneezing
Anti- korpi newtralizzanti (inibizzjoni ta ’ fattur IX) * Sensittività eċċessiva/ reazzjonijiet allerġiċi; dawn ir- reazzjonijiet jistgħu jinkludu anafilassi *, spażmi fil- bronki/ diffikultà biex tieħu n- nifs, pressjoni baxxa, anġjodema, takikardja, tagħfis tas- sider, urtikarja ġeneralizzata, urtikarja, raxx, sensazzjoni ta ’ ħruq fix- xedaq u l- kranju, reżħiet (rogħda), tingiż, fwawar, telqa, irrikwitezza, sogħla xotta/ għatis
* See additional
* Ara informazzjoni
information below.
oħra aktar `l isfel.
Hypersensitivity/ allergic reactions
Sensittività eċċessiva / reazzjonijiet allerġiċi
Hypersensitivity or allergic reactions have been infrequently observed in patients treated with factor IX containing products, including BeneFIX.
Sensittività eċċessiva jew reazzjonijiet allerġiċi kienu osservati spiss f’ pazjenti li kienu kkurati bi prodotti tal- fattur IX, inkluż BeneFIX.
In some cases, these reactions have progressed to severe anaphylaxis.
F’ xi każi, dawn ir- reazzjonijiet wasslu għal anaflassi serja.
Allergic reactions have occurred in close temporal association with development of factor IX inhibitor (see also section 4.4).
Reazzjonijiet allerġiċi dehru f’ assoċjazzjoni temporanja ma ’ l- iżvilupp ta ’ impeditur tal- fattur IX (ara wkoll sezzjoni 4. 4).
The aetiology of the allergic reactions to BeneFIX has not yet been elucidated.
L- etjoloġija tar- reazzjonijiet allerġiċi għall- BeneFIX għadha ma ġietx iċċarata.
These reactions are potentially life-threatening.
Dawn ir- reazzjonijiet jistgħu jkunu ta ’ theddida għall- ħajja.
If allergic/ anaphylactic reactions occur, the administration of BeneFIX should be discontinued at once.
Jekk jidhru reazzjonijiet allerġiċi/ anaflattiċi, BeneFIX għandu jitwaqqaf minnufih.
In case of severe allergic reactions, alternative haemostatic measures should be considered.
F’ każ ta ’ reazzjonijiet allerġiċi serji, għandhom ikunu kkunsidrati miżuri emostatiċi alternattivi.
The treatment required depends on the nature and severity of side-effects (see also section 4.4).
Il- kura li jkun hemm bżonn tiddependi fuq in- natura u s- serjetà ta ’ l- effetti kollaterali (ara wkoll sezzjoni 4. 4).
Due to the production process BeneFIX contains trace amounts of hamster cell proteins.
Minħabba l- proċess ta ’ produzzjoni BeneFIX fih traċċi ta ’ proteini tal- ħamsters.
Hypersensitivity responses can occur.
Jista ’ jkun hemm l- effett ta ’ sensittività eċċessiva.
Inhibitor development
Żvilupp ta ’ l- impeditur
Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Pazjenti b’ emofilija B jistgħu jiżviluppaw anti- korpi newtralizzanti (impedituri) għall- fattur IX.
If such inhibitors occur, the condition may manifest itself as an insufficient clinical response.
Jekk jidhru dawn l- impedituri, il- kondizzjoni tista ’ tintwera bħala rispons kliniku mhux suffiċjenti.
In such cases, it is recommended that a specialised haemophilia centre be contacted.
Fil- każ li jidhru l- impedituri, hu rakkomandat li wieħed jikkuntattja ċ- ċentru speċjalizzat fuq l- emofilja.
A clinically relevant, low responding inhibitor was detected in 1 out of 65 BeneFIX patients (including 9 patients participating only in the surgery study) who had previously received plasma derived products.
Impeditur li jirrispondi ftit u li hu klinikament rilevanti nstab f’ wieħed minn 65 pazjent ta ’ BeneFIX (li kienu jinkludu 9 pazjenti li ħadu sehem fl- istudju kirurġiku) li qabel kienu ħadu prodotti derivati mill - plażma.
This patient was able to continue treatment with BeneFIX with no anamnestic rise in inhibitor or anaphylaxis.
Dan il- pazjent seta ’ jkompli l- klura b’ BeneFIX mingħajr l- ebda żjieda anamnestika ta ’ l - impeditur jew anaflassi.
There are insufficient data to provide information on inhibitor incidence in PUPs.
M’ hemmx biżżejjed informazzjoni sabiex jiġi fornut tagħrif fuq l- inċidenza ta ’ l- impeditur fil- pazjenti li ma kienux ikkurati qabel (PUP’ s).
Nephrotic syndrome has been reported following high doses of plasma derived Factor IX to induce immune tolerance in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
7 Is- sindromu nefrotiku kien rappurtat, wara dożi qawwija ta ’ Fattur IX derivat mill- plażma, biex jikkaġuna tolleranza immuni f’ pazjenti ta ’ l- emofilja B li għandhom l- impedituri għall- fattur IX u li kellhom reazzjonijiet allerġiċi fil- passat.
7 Renal
Renali
In a clinical trial, twelve days after a dose of BeneFIX for a bleeding episode, one hepatitis C antibody positive patient developed a renal infarct.
Fi prova klinika, tnax- il jum wara doża ta ’ BeneFIX wara episodju ta ’ fsada, pazjent li kien pożittiv għall- antikorp ta ’ l- epatite Ċ żviluppa infart fil- kliewi.
The relationship of the infarct to prior administration of BeneFIX is uncertain.
Ir- relazzjoni ta ’ l- infart ma ’ l- għoti ta ’ BeneFIX mhiex ċerta.
The patient continued to be treated with BeneFIX.
Il- pazjent kompla jiġi kkurat b’ BeneFIX.
Pharmacotherapeutic group: antihaemorrhagic Blood Coagulation Factor IX; ATC code:
Fattur IX tal- Koagulazzjoni tad- Demm kontra l- emorraġġiji; Kodiċi ATC:
BeneFIX contains recombinant coagulation factor IX, (nonacog alfa).
BeneFIX fih il- fattur IX, (Nonacog alfa) tal- koagulazzjoni rikombinanti.
Recombinant coagulation factor IX is a recombinant DNA-based protein therapeutic which has structural and functional characteristics comparable to endogenous factor IX.
Il- fattur IX tal- koagulazzjoni rikombinanti li huwa glikoproteina ta ’ katina waħda b’ piż molekulari ta ’ madwar 55, 000 Daltons, jagħmel parti mill- grupp ta ’ serine protease tal- fatturi ta ’ koagulazzjoni dipendenti fuq il- vitamina K tal- fattur IX tal- koagulazzjoni rikombinanti li hi proteina terapewtika bbażata fuq id- DNA rikombinanti li għandha karatteristiċi strutturali u ta ’ funzjoni komparabbli mal- fattur IX endoġenu.
Factor IX is activated by factor VII/ tissue factor complex in the extrinsic pathway as well as factor XIa in the intrinsic coagulation pathway.
Il - fattur IX hu attivat permezz tal- kumpless tal- fattur VII/ fattur tat- tessut fil- passaġġ estrinsiku, kif ukoll permezz tal- fattur XIa fil- passaġġ intrinsiku tal- koagulazzjoni.
Activated factor IX, in combination with activated factor VIII, activates factor X.
Il- fattur IX attivat, flimkien mal- fattur VIII attivat, jattivaw il- fattur X.
This results ultimately in the conversion of prothrombin to thrombin.
Dan jikkawża t- tibdil ta ’ prothrombin fi thrombin.
Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Thrombin imbagħad jibdel il- fibrogen f’ fibrin u jista ’ jifforma embolu.
Factor IX activity is absent or greatly reduced in patients with haemophilia B and substitution therapy may be required.
L- attività tal- fattur IX hi assenti jew imnaqqsa sew f’ pazjenti bl- emofilja B u jista ’ jkun hemm bżonn terapija ta ’ sostituzzjoni.
Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
L- emofilja B hi marda ereditarja tal- koagulazzjoni tad- demm minħabba livelli mnaqqsa ta ’ fattur IX u tirriżulta fi fsada fil- ġogi, fil- muskoli u fl- organi interni, li tkun spontaneja jew bħala riżultat ta ’ trawma aċċidentali jew kirurġika.
By replacement therapy the plasma levels of factor IX is increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Permezz tat- terapija ta ’ sostituzzjoni jiżdid l- livelli tal- fattur IX fil - plażma, b’ tali mod li joħolqu korrezzjoni temporanja tan- nuqqas tal- fattur u korrezzjoni tat- tendenzi ta ’ fsada.
There are insufficient data to recommend the use of BeneFIX in children less than 6 years of age.
M’ hemmx biżżejjed informazzjoni biex jiġi rakkomandat l- użu ta ’ BeneFIX fi tfal li għandhom inqas minn 6 snin.
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.
Infusion of BeneFIX into 56 PTP patients (baseline data) with haemophilia B has shown an in vivo recovery ranging from 15 to 62% (mean 33.7 +/ - 10.3%).
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%).
One International Unit of BeneFIX showed a mean 0.75 IU/ dl (range 0.3 to 1.4 IU/ dl) increase in the circulating level of factor IX.
Unità Internazzjonali waħda ta ’ BeneFIX uriet medja ta ’ 0. 75 IU/ dl (bejn 0. 3 sa 1. 4 IU/ dl) żjieda fil- livell ta ’ ċirkulazzjoni tal- fattur IX.
The biologic half- life ranged from 11 to 36 hours (mean of 19.3 +/ - 5.0 hours).
Il- half- life bijoloġiku kien ivarja bejn 11 u 36 siegħa (medja ta ’ 19. 3 + / - 5. 0 sigħat).
For a subset of the 56 patients, data are available from baseline to 24 months.
8 Għal proporzjon minn dawn is- 56 pazjent, l- informazzjoni hi disponibbli mill- linja bażi ta ’ referenza sa 24 xahar.
The pharmacokinetic data for these patients at various time points are shown in the following table:
Fit- tabella li ġejja jidher it- tagħrif farmakokinetiku ta ’ dawn il- pazjenti f’ ħinijiet differenti:
8 Table 1.
19. 8
Recombinant Factor IX Summary of Pharmacokinetic Parameters for Activity Data by Month in Previously Treated Patients
6. 26
Parameter Recovery (%)
9. 6– 38. 2
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
18. 1, 21. 6
FIX increase (IU/ dl per IU/ kg)
eliminazzjoni
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
5. 89
Elimination half-life (hrs)
10. 6– 33. 7
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
16. 8, 20. 2
AUC0- ∞ (IU × hr/ dl) Half-life
(sigħat) AUC0- ∞ (IU x hr/ dl)
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
16. 8, 21. 0 16. 8, 20. 9 578. 1, 661. 5 539. 5, 620. 1 532. 4, 619. 1 515. 7, 608. 0 531. 1, 624. 1 1. 6, 2. 5
Initial Phase (hrs)
Inizzjali (sigħat)
52 48 44 43
48 44 43 56
2.3 2.2 2.0 1.8
2. 2 2. 0 1. 8 8. 4
1.0 1.2 1.3 0.78
1. 2 1. 3 0. 78 8. 2
2.62 2.70 1.94 2.07
2. 70 1. 94 2. 07 2. 01
0.12-9.98 0.13-14.34 0.13-6.21 0.11-7.43
0. 13- 14. 34 0. 13- 6. 21 0. 11- 7. 43 4. 66- 13. 64
1.5,3.0 1.5,3.0 1.4,2.6 1.1,2.4
1. 5, 3. 0 1. 4, 2. 6 1. 1, 2. 4 7. 86, 8. 94
Clearance (ml/ hr/ kg)
idum biex jiġi eliminat (ml/ siegħa/ kg)
8.4 9.2 9.3 9.6 9.2
9. 3 9. 6 9. 2
8.2 8.9 8.8 8.9 9.1
8. 8 8. 9 9. 1
2.01 2.48 2.53 2.85 2.40
2. 53 2. 85 2. 40
4.66-13.64 5.55-15.11 4.63-17.22 5.31-19.65 4.78-17.60
4. 63- 17. 22 5. 31- 19. 65 4. 78- 17. 60
7.86,8.94 8.53,9.89 8.56,10.01 8.78,10.47 8.52,9.96
8. 56, 10. 01 8. 78, 10. 47 8. 52, 9. 96
MRT (hrs)
MRT (sigħat)
0 6 12 18 24
12
56 53 49 46 45
49 24. 6
26.0 25.6 24.6 24.7 25.1
22. 75, 26. 47
25.8 25.3 22.2 22.7 23.9
15. 30- 50. 75
6.07 5.68 6.47 7.40 6.94
22. 55, 26. 94
15.81-46.09 13.44-42.26 14.83-38.75 15.30-50.75 15.65-47.52
24
24.35,27.60 24.01,27.15 22.75,26.47 22.55,26.94 23.00,27.17
45 25. 1
Data exclude those collected from one patient after evidence of inhibitor development was observed at 9 months.
23. 9
AUC0 - ∞ = Area Under the Curve MRT = Mean Residence Time SD = Standard Deviation CI = Confidence Interval
AUC0 - ∞ = Area Under the Curve - Żona taħt il- Kurva MRT = Mean Residence Time - Ħin Medju ta ’ Residenza SD = Standard Deviation – Devjazzjoni Standard CI = Confidence Interval – Intervall ta ’ Kunfidenza
A 28% lower recovery of recombinant Factor IX in comparison to plasma derived Factor IX was shown.
Intwera li kien hemm tnaqqis ta ’ 28% fl- irkupru ta ’ Fattur IX rikombinanti meta mqabbel ma ’ Fattur IX derivat mill- plażma.
Pharmacokinetic parameters of recombinant Factor IX have also been determined after single and multiple intravenous doses in different species.
Il- parametri farmakokinetiċi ta ’ Fattur IX rikombinanti kienu stabbiliti wkoll wara li ngħataw dożi ġol- vina mogħtija darba u aktar fi speċi differenti.
The pharmacokinetic parameters obtained in studies comparing
Il- parametri farmakokinetiċi miksuba fi studji fejn ġew imqabbla Fattur IX rikombinanti u Fattur IX derivat mill- plażma kienu bħal
9 recombinant Factor IX to plasma derived Factor IX were similar to those obtained in human studies.
9 dawk miksuba fl- istudji li saru fuq il- bniedem.
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.
Jidher li d- differenzi strutturali fil- molekula ta ’ Fattur IX rikombinanti meta mqabbla ma ’ Fattur IX derivat mill- plażma jikkontibwixxu għad- differenza fl - irkupru.
Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity.
Informazzjoni li mhix klinika, magħmula fuq studji konvenzjonali ta ’ l- effett tossiku fuq il- ġeni, ma turi l- ebda periklu speċjali għall- bnedmin.
No investigations on carcinogenicity, fertility impairment and foetal development have been conducted.
Ma sar l- ebda stħarriġ dwar il- karċinoġeniċità, dwar il- ħsara fil- fertilità jew fl- iżvilupp tal- fetu.
Powder Sucrose Glycine L-Histidine Polysorbate 80
Trab Sucrose Glycine L- histidine Polysorbate 80
Solvent Water for injection
Solvent Ilma għall- injezzjoni
Only the provided infusion set should be used.
Is- sett ta ’ l- infużjoni fornut biss għandu jintuża.
Treatment failure can occur as a consequence of human coagulation factor IX adsorption to the internal surfaces of some infusion equipment.
Falliment tal- kura jista ’ jseħħ bħala konsegwenza ta ’ assorbiment tal- fattur IX ta ’ koagulazzjoni tal- bniedem fl- uċuh interni ta ’ xi tagħmir ta ’ l- infużjoni.
The reconstituted product should be used immediately, but no longer than 3 hours after reconstitution.
3 snin
Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25oC.
L- istabbiltà kimika u fiżika waqt l- użu kienet murija għal 3 sigħat f’ temperaturi sa 25ºC.
Store and transport refrigerated (2°C - 8°C).
Żommu kiesaħ waqt il- ħażna u l- ġarr (2ºC - 8ºC).
For the purpose of ambulatory use the product may be removed from refrigerated storage for one single period of maximum 1 month at room temperature (up to 25 ºC).
Għall- għan ta ’ użu ambulatorju, il- prodott jista ’ jinħareġ mill- ħażna fil- friġġ għall- perijodu wieħed sa massimu ta ’ xahar fit- temperatura tal- kamra (sa 25ºC).
At the end of this period, the product should not be put back in the refrigerator, but should be used or discarded.
Fi tmiem dan il- perijodu, il- prodott m’ għandux jitpoġġa lura fil- friġġ, iżda għandu jintuża jew jintrema.
250 IU of powder in a vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium).
250 IU ta ’ trab f’ kunjett (ħġieġ ta ’ Tip I) b’ tapp (chlorobutyl) u siġill flip- off (aluminium).
A tip-cap (bromobutyl) and a sterile filter spike, a sterile infusion set, two alcohol swabs, two plasters.
Għatu tat - tarf (bromobutyl) u ponta tal- filtru sterili, sett sterili ta ’ l- infużjoni, żewġ biċċiet bl- alkoħol biex tnaddaf u żewġ impjastri..
10 6.6 Special precautions for disposal and other handling
10 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Detailed instructions for preparation and administration are contained in the user package leaflet provided with BeneFIX.
Struzzjonijiet dettaljati dwar il- preparazzjoni u t- teħid tal- prodott jinsabu fil- fuljett ta ’ tagħrif pprovdut ma ’ BeneFIX.
Reconstitute lyophilised BeneFIX powder for solution for injection with the supplied solvent (water for injection) using the sterile double-ended transfer needle.
Irrikostitiwixxi t- trab BeneFIX lijofilizzat għas- soluzzjoni għall- injezzjoni bis- solvent ipprovdut (ilma għall- injezzjonijiet) billi tuża labra sterili tat- trasferiment b’ tarf doppju.
Reconstitution should be performed on a flat level surface such as a table to ensure that the needle is positioned properly on top of the vial, inserted vertically i. e. perpendicular to the stopper surface Gently rotate the vial until all powder is dissolved.
Dawwar bil- mod il- kunjett sakemm it- trab kollu jinħall.
After reconstitution, the solution is drawn through the sterile filter spike (supplied) into a sterile disposable syringe.
Wara r- rikostituzzjoni, is- soluzzjoni għandha tinġibed bil- labra tal- filtru sterilizzata (fornuta) għal ġo siringa sterlizzata li tintrema wara li tintuża.
The solution should be discarded if visible particulate matter or discolouration is observed.
Is- soluzzjoni għandha tintrema jekk ikun fiha xi frak jew jekk tkun mdardra.
BeneFIX is administered by intravenous (IV) injection after reconstitution of the lyophilised powder for injection with the supplied water for injections.
BeneFIX jingħata b’ injezzjoni ġol- vini (IV) wara r- rikostituzzjoni tat- trab lijofilizzat għall- injezzjoni bl- ilma għall- injezzjonijiet li hu pprovdut.
BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2- ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Meta rikostitwit, BeneFIX ikun fih polysorbate- 80, li hu magħruf li jgħolli r- rata ta ’ l- estrazzjoni ta ’ di - (2- ethylhexyl) phthalate (DEHP) minn polyvinyl chloride (PVC).
This should be considered during the preparation and administration of BeneFIX.
Dan għandu jiġi kkunsidrat waqt il- preparazzjoni u l- għoti ta ’ BeneFIX, inkluż il- ħin tal- ħażna li jkun għadda f’ kontenitur tal- PVC wara rikostituzzjoni.
It is important that the recommendations in section 4.2 be followed closely.
Huwa importanti li r- rakkomandazzjonijiet f’ sezzjoni 4. 2 jiġu segwiti mill- qrib.
The reconstituted solution should be used immediately or within 3 hours.
Is- soluzzjoni rikostitwita għandha tintuża immedjatament jew fi żmien 3 sigħat.
Because the use of BeneFIX by continuous infusion has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip.
Minħabba li l- użu ta ’ BeneFIX permezz ta ’ infużjoni kontinwa ma kienx evalwat, BeneFIX m’ għandux jitħallat ma ’ soluzzjonijiet oħra ta ’ l- infużjoni jew jingħata fi dripp.
27 August 1997 Date of last renewal:
27 ta’ Awissu 1997 Data ta 'l- aħħar tiġdid:
27 August 2007
27 ta 'Awissu, 2007
Detailed information on this medicinal product is available on the website of the European Medicine Agency (EMEA) http: / /www. emea. europa. eu/
11 Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
BeneFIX 500 IU powder and solvent for solution for injection.
BeneFIX 500 IU trab u solvent għal soluzzjoni għall- injezzjoni
Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX).
Kull kunjett nominalment 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 li hu pprovdut miegħu, kull 1 ml tas- soluzzjoni jkun fih madwar 100 IU nonacog alfa.
Each vial contains 50 mg sucrose.
Kull kunjett fih 50 mg ta ’ sucrose.
13 parameters such as half-life and recovery, as well as the clinical situation into consideration in order to adjust the dose as appropriate.
13 L- ammont li għandu jingħata u kull kemm għandu jingħata għandhom dejjem jitqiesu skond l - effettività klinika fil- każ individwali.
For a recovery 0.7 IU/ dl (average increase of factor IX), then:
Għal irkupru 0. 7 IU/ dl (żjieda medja ta ’ fattur IX), imbagħad:
Degree of haemorrhage/ Type of surgical procedure Haemorrhage
14 Grad ta ’ emorraġija/ Tip ta ’ proċedura kirurġika Emorraġija
In patients with high levels of inhibitor factor IX therapy may not be effective and other therapeutic options must be considered.
15 F’ pazjenti b’ livelli għoljin ta ’ impeditur għall- fattur IX it- terapija tista ’ ma tkunx effettiva u għandhom jiġu kkunsidrati għażliet terapewtiċi oħra.
BeneFIX is administered by intravenous infusion after reconstitution of the lyophilised powder for solution for injection with sterile water for injection (see section 6.6).
BeneFIX jingħata b’ infużjoni ġol- vina wara li t- trab ikun ġie rikostitwit għal soluzzjoni għal injezzjoni b’ ilma sterilizzat għall- injezzjoni (ara sezzjoni 6. 6).
BeneFIX should be administered at a slow infusion rate.
BeneFIX għandu jingħata b’ rata ta ’ infużjoni baxxa.
In most of the cases, an infusion rate of up to 4 ml per minute has been used.
Fil- maġġoranza tal- każi, rata ta ’ infużjoni sa ’ 4 ml kull minuta intużat.
The rate of administration should be determined by the patient’ s comfort level.
Ir- rata ta ’ l- għoti għandha tkun stabbilita skond il- livell ta ’ komfort tal - pazjent.
Sufficient data have not been obtained from ongoing clinical studies on the treatment of previously untreated patients (PUPs), with BeneFIX.
Ma ġietx miksuba biżżejjed informazzjoni minn studji kliniċi li qed isiru bħalissa dwar il- kura ta ’ pazjenti mhux trattati qabel, b’ BeneFIX.
If allergic or anaphylactic-type reactions occur, the administration of BeneFIX has to be discontinued immediately and an appropriate treatment has to be initiated.
Jekk jidhru reazzjonijiet ta ’ allerġija jew ta ’ anafilassi, t- teħid ta ’ BeneFIX għandu jitwaqqaf immedjatament u għandha tinbeda il- kura xierqa.
In the case of shock, the current medical standards for treatment of shock should be observed.
Fil- każ ta ’ xokk, l- istandards mediċi attwali għall - kura ta ’ xokk għandhom jiġu osservati.
Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product.
16 għandhom jiġu osservati mill- qrib għal sinjali ta ’ reazzjonijiet ta ’ sensittività eċċessiva akuta, b’ mod partikulari matul il- fażijiet bikrin ta ’ l- espożizzjoni inizjali għall- prodott.
Because of the risk of allergic reactions with factor IX concentrates, the initial administrations of factor IX should, according to the treating physician’ s judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Minħabba r- riskju ta ’ reazzjonijiet allerġiċi għall- konċentrati ta ’ fattur IX, l- għoti inizjali ta ’ fattur IX għandu, skond il- parir tat- tabib li qiegħed jikkura, isir taħt sorveljanza medika fejn tkun tista ’ tingħata kura medika xierqa għal reazzjonijiet allerġiċi.
Since the use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications, the use of factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with
Billi l- użu ta ’ konċentrati kumplessi tal- fattur IX kien storikament assoċjat mal- kumplikazzjonijiet tromboembolitiċi, l- użu ta ’ prodotti li fihom il- fattur IX jista ’ jkun ta ’ periklu f’ pazjenti b’ sinjali ta ’ fibrinolożi u f’ pazjenti li għandhom koagulazzjoni intravaskulari mifruxa (DIC).