qanastek/EMEA-V3 huggingface dataset:
To ensure that the needle is in the vein, check for blood return by pulling back very slightly on the plunger of the syringe.
Sabiex tiżgura li l- labra hi fil- vina, iċċekkja jekk jitlax xi demm meta tiġbed lura bil- mod ħafna l- planġer tas- siringa.
Stop pulling back the plunger when blood enters the tubing and inject BeneFIX intravenously over several minutes.
Tibqax tiġbel lura l- planġer meta d- demm jidħol fit- tubu u injetta BeneFIX ġol- vina għal diversi minuti.
In most of the cases an infusion rate with a maximum of up to 4 ml per minute was well tolerated BeneFIX should be injected intravenously over several minutes.
Fil- maġġoranza tal- każijiet, rata ta ’ infużjoni sa ’ 4 ml kull minuta kienet tollerata sew.
Your doctor may change your recommended infusion rate to make the infusion more comfortable.
BeneFIX għandu jiġi injettat ġol- vina għal perijodu ta ’ diversi minuti.
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 ġiex evalwat, BeneFIX m’ għandux jitħallat ma ’ soluzzjonijiet oħra ta ’ infużjoni jew ikun mogħti permezz tad- dripp.
Please dispose of all unused solution, empty vials and used needles and syringes in an appropriate container for throwing away waste as it may hurt others if not handled properly.
Jekk jogħġbok armi s- soluzzjoni kollha li ma ntużatx, fjali vojta, labar u siringi wżati f’ kontenitur xieraq għal skart li għandu jintrema peress li jista ’ jweġġa ’ lil ħaddieħor jekk ma jkunx maniġġat kif suppost.
If you take more BeneFIX than you should:
Jekk tieħu BeneFIX aktar milli suppost:
Please contact your doctor immediately if you inject more BeneFIX than your doctor recommends.
Jekk jogħġbok ikkuntattja lit- tabib tiegħek immedjatament jekk tinjetta aktar BeneFIX milli t- tabib tiegħek jirrakomandalek.
If you stop taking BeneFIX
Jekk tieqaf tieħu BeneFIX
Like all medicines, BeneFIX can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, BeneFIX jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Should you experience a significant increase in your usage of BeneFIX in order to control a bleed, please contact your doctor immediately; your blood should be checked for inhibitors to factor IX activity.
Jekk ikollok bżonn iżżid b’ mod sinifikanti l- użu ta ’ BeneFIX sabiex tikkontrolla l- fsada, jekk jogħġbok ikkuntattja lit- tabib tiegħek immedjatament; id- demm tiegħek għandu jkun iċċekkjat għal attività ta ’ impedituri tal- fattur IX.
Possible side effects are listed according to the following categories:
Effetti oħra possibli huma mniżżla skond il- kategoriji li ġejjin:
between 1 in 100 and 1 in 1,000 patients between 1 in 1,000 and 1 in 10,000 patients
bejn 1 f’ 100 u 1 f ’ 1, 000 pazjent bejn 1 f ’ 1, 000 u 1 f’ 10, 000 pazjent
Development of neutralising antibodies (inhibitors)* Hypersensitivity/ allergic reactions; such reactions may include burning sensation in jaw and skull, chills (rigors), dry cough/ sneeze, flushing, lethargy, restlessness, tingling, hives, itching and rash, low blood pressure, fast heart rate, tightness of the chest, wheezing, swelling of the throat, anaphylaxis*, rash
Żvilupp ta ’ l- anti- korpi newtralizzanti (impedituri) * Sensittività eċċessiva/ reazzjonijiet allerġiċi; dawn ir- reazzjonijiet jistgħu jinkludu sensazzjoni ta ’ ħruq fix- xedaq u fil- kranju, reżħiet (rogħda), sogħla xotta/ għatis, fwawar, telqa, tħossok li m’ għandekx kwiet f’ ġismek, tingiż, ħorriqija, ħakk u raxx, pressjoni tad- demm baxxa, taħbit mgħaġġel tal- qalb, tagħfis tas- sider, tisfir man- nifs, nefħa fil- griżmejn, anafilassi *, raxx.
124 Nervous system disorders
Disturbi fis- sistema nervuża
Gastrointestinal
Disturbi gastrointestinali
Nausea Vomiting
Tqallih Remettar
General disorders and administration site conditions
117 Disturbi ġenerali u kondizzjonijiet fil- lok ta ’ l- injezzjoni
Injection site reactions (including burning and stinging at the infusion site), discomfort at the IV site, cellulitis, phlebitis
Reazzjonijiet fejn issir l- injezzjoni (inkluż ħruq u tingiż fil- post ta ’ l- infużjoni), skumdità mnejn tingħata l- injezzjoni, ċellulite, flebite
* See additional
Rari:
information below.
* Ara aktar informazzjoni hawn taħt.
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 qed jiġu 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 anafilassi gravi.
Allergic reactions have occurred in close temporal association with development of factor IX inhibitor (see also “ Take special care with BeneFIX ”).
Reazzjonijiet allerġiċi dehru f’ assoċjazzjoni temporanja fil- qrib ma ’ l- iżvilupp ta ’ impeditur tal - fattur IX (ara wkoll “ Oqgħod attent ħafna b’ BeneFIX ”).
If allergic/ anaphylactic reactions occur, stop the infusion immediately and contact your doctor or seek emergency medical care immediately.
Jekk jidhru reazzjonijiet allerġiċi/ anaflattiċi t- teħid ta’ BeneFIX għandu jitwaqqaf minnufih.
In case of severe allergic reactions, alternative therapy should be considered.
F’ każ ta ’ reazzjonijiet allerġiċi serji, miżuri emostatiċi alternattivi għandhom ikunu kkunsidrati.
The treatment required depends on the nature and severity of side-effects (see also “ Take special care with BeneFIX ”).
Il- kura li jkun hemm bżonn tiddependi minn natura u s- serjetà ta ’ l - effetti kollaterali (ara wkoll “ Oqgħod attent ħafna b’ BeneFIX ”).
Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Pazjenti li jbatu bl- 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 ’ timanifesta ruħha bħala rispons kliniku mhux suffiċjenti.
In such cases, it is recommended that a specialised haemophilia centre be contacted.
F’ dawn il- każijiet, hu rakkomandat li wieħed jikkuntattja iċ- ċentru speċjaliżżat fuq l - emofilja.
A clinically relevant, low responding inhibitor was detected in 1 out of 65 BeneFIX patients who had previously received plasma derived products.
Impeditur li jirrispondi ftit u li hu klinikament rilevanti nstab f’ wieħed minn 65 pazjent tal- BeneFIX li qabel kienu ħadu prodotti derivati mill- plażma.
This patient was able to continue treatment with BeneFIX with no rise in inhibitor or anaphylaxis.
Dan il- pazjent seta ’ jkompli l- kura b’ BeneFIX mingħajr l- ebda żjieda anamnestika ta ’ l- impeditur jew anafilassi.
Patients treated with BeneFIX should be monitored for inhibitor development.
Il- pazjenti li jingħataw kura bil - BeneFIX għandhom ikunu sorveljati għal żvilupp ta ’ l- impeditur.
There are insufficient data to provide information on inhibitor incidence in previously untreated patients (PUPs).
M’ hemmx biżżejjed informazzjoni sabiex jiġi fornut tagħrif fuq l- inċidenza ta ’ l- impeditur fil- pazjenti li ma kienux ikkurati qabel.
Due to the production process BeneFIX may contain trace amounts of hamster proteins.
Minħabba l- proċess ta ’ produzzjoni BeneFIX jista ’ jkun fih traċċi ta ’ proteini tal- ħamsters.
Hypersensitivity responses can occur.
Jista ’ jkun hemm sensittività eċċessiva.
A kidney disorder 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 (see also “ Take special care with BeneFIX ”).
Kien hemm rapporti ta ’ disturbi fil- kliewi, wara dożi qawwija ta ’ Fattur IX derivat mill- plażma, għal tolleranza immuni f’ pazjenti li jbatu bl- emofilja B għall- impedituri tal- fattur IX u li kellhom reazzjonijiet allerġiċi fil- passat (ara wkoll “ Oqgħod attent ħafna b’ BeneFIX ”).
125 Renal
Renali
One patient developed severe abdominal pain which was caused by an area of the kidney that lacked the necessary blood supply (referred to as a renal infarct).
Pazjent qabdu uġigħ qawwi fl- addome li kien ikkaġunat minn parti fil- kliewi li ma kellhiex l- provvista ta ’ demm meħtieġ (magħruf bħala infart tal- kliewi).
The relationship of the infarct to prior administration of BeneFIX is uncertain.
Ir- relazzjoni ta ’ infart ma ’ l- għoti ta ’ qabel ta ’ BeneFIX mhix ċerta.
If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE BENEFIX
KIF TAĦŻEN BENEFIX
Do not use after the expiry date stated on the outer box and vial label.
Tużax wara d- data ta ’ skadenza li tidher fuq il- kaxxa ta ’ barra u t- tikketta tal- kunjett.
Store in a refrigerator (2°C to 8°C) For the convenience of the patient the product can be removed from such storage for one single period of maximum 1 month at room temperature (up to 25°C).
Għall- konvenjenza tal- pazjent, il- prodott jista ’ jinħareġ minn fejn ikun maħżun għal perijodu wieħed sa massimu ta 'xahar, u jinżamm 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.
Fit- tmiem ta 'dan il- perijodu, il- prodott m’ għandux jitpoġġa lura fil- friġġ, iżda għandu jintuża jew jintrema.
The date the product is removed from the refrigerator and set at room temperature (not exceeding 25oC) and the date the bottle should be withdrawn should be noted on the outer carton.
Id- data li fiha l- prodott jtitneħħa mill- friġġ u jitpoġġa fit- temperatura tal- kamra (li ma tkunx iktar minn 25ºC) u d- data ta 'meta l- flixkun għandu jintrema, għandhom jinkitbu fuq il- kartuna ta' barra.
Use the reconstituted solution immediately, but no longer than 3 hours after reconstitution.
Uża s- soluzzjoni rikostitwita immedjatament, iżda mhux iktar tard minn 3 sigħat wara r - rikostituzzjoni.
Do not use BeneFIX if the solution is not clear and colourless.
Tużax BeneFIX jekk is- soluzzjoni ma tkunx ċara u bla kulur.
It is recommended that, whenever possible, every time you use BeneFIX, the lot number of the product found on the vial is recorded.
Hu rakkomandat li, kull meta jkun possibbli, kull darba li tuża BeneFIX, jinkiteb in- numru tal- lott tal - prodott li jinsab fuq il- kunjett.
What BeneFIX contains
X’ fih BeneFIX
Each vial of BeneFIX
− Is- sustanza attiva hi nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti).
Water for injection is also
Kull kunjett ta ’ BeneFIX nominalment fih 250 IU nonacog alfa. − Is- sustanzi l- oħra huma: sucrose, glycine, L- histidine, polysorbate 80.
- After reconstitution with the supplied water for injection, each vial contains 50 IU of nonacog alfa
Ilma għall- injezzjonijiet hu fornut ukoll għar- rikostituzzjoni. − Wara r- rikostituzzjoni bl- ilma għall- injezzjoni ipprovdut, kull kunjett ikun fih 50 IU nonacog alfa f’ kull 1 ml tas- soluzzjoni għall- injezzjoni ppreparata.
What BeneFIX looks like and contents of the pack
Id- dehra ta ’ BeneFIX u d- daqs tal- pakkett
BeneFIX is provided as a powder for injection in a glass vial.
BeneFIX hu pprovdut bħala trab għall- injezzjoni fi kunjett tal- ħġieġ.
126 • one vial of BeneFIX 250 IU powder • one vial, 5 ml sterile water • 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 ta ’ trab BeneFIX 250 IU • kunjett wieħed b’ 5 ml ilma sterili għall- injezzjonijiet • labra waħda b’ żewġt itruf • ponta tal- filtru waħda • mini- sett sterili wieħed ta ’ l- infużjoni • siringa sterili waħda ta ’ 10 ml li tintrema wara li tintuża għall- għoti • żewġ biċċiet bl- alkoħol • żewġ garżi
Manufacturer
119 Manifattur
127 128 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
120 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
България / Eesti/ Latvija/ Lietuva/ Österreich / România/ Slovenija Wyeth-Lederle Pharma GmbH Tel/ Tãlr: +43 1 89 1140 Faks/ Fakss/ Faksas/ Fax: +43 1 89 114600
България/ Eesti/ Latvija/ Lietuva / Österreich / România / Slovenija Wyeth- Lederle Pharma GmbH
Tel: +31 23 567 2567 Fax: +31 23 567 2599
Fax: +31 23 567 2599
Slovenská Republika Wyeth Whitehall Export GmbH, organizač ná zlož ka Tel: +42 1 2 654 128 16 Fax: +42 1 2 654 128 17
Slovenská Republika Ireland Wyeth Whitehall Export GmbH, Wyeth Pharmaceuticals organizačná zložka Tel: +353 1 449 3500 Tel: +42 1 2 654 128 16 Fax: +353 1 679 3773 Fax: +42 1 2 654 128 17
Sími: +354 540 8000 Fax: +354 540 8001
121 Suomi/ Finland Ísland Wyeth Icepharma hf.
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Dan ifisser li minħabba li l- marda li qed tbati minnha hija rari, kien impossibbli li tinkiseb informazzjoni kompleta dwar din il- mediċina.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/ There are also links to other websites about rare diseases and treatments.
Hemm ukoll links għall- websites oħra dwar mard rari u kura.
130 PACKAGE LEAFLET:
122 FULJETT TA ’ TAGĦRIF:
- Keep this leaflet.
− Żomm dan il- fuljett.
their symptoms are the same as yours.
TAGĦTIHIEX lil persuni oħra.
- 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.
tell your doctor or pharmacist.
F’ dan il- fuljett:
Before you take BeneFIX 3.
Qabel ma ’ tieħu BeneFIX 3.
WHAT IS BENEFIX AND WHAT IT IS USED FOR
X’ INHU BENEFIX U GĦALXIEX JINTUŻA
(PTPs) receiving factor IX-containing products.
− Antikorpi li jinnewtralizzaw l- attività (inibituri) huma avveniment mhux komuni f’ pazjenti li kienu ġew ikkurati qabel (PTP’ s) u li qed jirċievu prodotti li fihom il- 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, b’ BeneFIX qabel.
- Clinical studies on BeneFIX did not determine whether patients aged 65 and over respond
123 − L- istudji kliniċi fuq BeneFIX ma stabilixxux jekk pazjenti li għandhom 65 sena jew aktar jirrispondux b’ mod differenti minn pazjenti iżgħar.
The
− Bħal kull prodott ta ’ proteina li jittieħed ġol- vina, reazzjonijiet ta ’ sensittività eċċessiva tat- tip allerġiku huma possibli.
IX inhibitor and allergic reactions.
− Kien hemm rapporti li wrew korrelazzjoni bejn in- numru ta ’ każijiet ta ’ impeditur tal- fattur IX u r- reazzjonijiet allerġiċi.
Patients who have
− Il- produzzjoni ta ’ fattur IX fil- ġisem hi kkontrollata mill- ġene ta ’ fattur IX.
major 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.
- If you suffer from a liver or cardiac disease or if you have recently had surgery, there is an
− Jekk tbati minn mard tal- fwied jew mard tal- qalb jew jekk għamilt xi operazzjoni riċentement, hemm riskju ogħla ta ’ kumplikazzjonijiet għal koagulazzjoni.
132 Taking other medicines:
124 Meta tuża mediċini oħra:
BeneFIX should be administered using a single sterile disposable plastic syringe.
BeneFIX għandu jittieħed bl- użu ta ’ siringa tal- plastik sterilizzata li tintrema wara li tintuża.
Development of neutralising antibodies (inhibitors)* Hypersensitivity/ allergic reactions; such reactions may include burning sensation in jaw and skull, chills (rigors), dry cough/ sneeze, flushing, lethargy, restlessness, tingling, hives, itching and rash, low blood pressure, fast heart rate, tightness of the chest, wheezing, swelling of the throat, anaphylaxis*, rash
Żvilupp ta ’ l- anti- korpi newtralizzanti (impedituri) * Sensittività eċċessiva/ reazzjonijiet allerġiċi; dawn ir- reazzjonijiet jistgħu jinkludu sensazzjoni ta ’ ħruq fix- xedaq u fil- kranju, reżħiet (rogħda), sogħla xotta/ għatis, fwawar fil- wiċċ, telqa, tħossok li m’ għandekx kwiet f’ ġismek, tingiż, urtikarja, ħakk u raxx, pressjoni tad- demm baxxa, taħbit tal- qalb mgħaġġel, tagħfis tas- sider, tisfir man- nifs, nefħa fil- griżmejn, anafilassi *, raxx.
135 Nervous system disorders
Disturbi fis- sistema nervuża
General disorders and administration site conditions
127 Disturbi ġenerali u kondizzjonijiet fil- lok ta ’ l- injezzjoni
Injection site reactions (including burning and stinging at the infusion site), discomfort at the IV site, cellulitis, phlebitis
Reazzjonijiet fejn issir l- injezzjoni (inkluż ħruq u tingiż fil- post ta ’ l- infużjoni), skumdità fil- post ġol- vina, ċellulite, flebite
136 Renal
Kliewi
Do not use after the expiry date stated on the outer box and vial label.
128 Tużax wara d- data ta ’ skadenza li tidher fuq il- kaxxa ta ’ barra u t- tikketta tal- kunjett.
Water for injection is also
Kull kunjett ta ’ BeneFIX nominalment fih 500 IU nonacog alfa. − Is- sustanzi l- oħra huma: sucrose, glycine, L- histidine, polysorbate 80.
- After reconstitution with the supplied water for injection, each vial contains 100 IU of nonacog alfa
Ilma għall- injezzjonijiet hu fornut ukoll għar- rikostituzzjoni. − Wara r- rikostituzzjoni bl- ilma għall- injezzjonijiet ipprovdut, kull kunjett jkun fih 100 IU nonacog alfa f’ kull 1 ml tas- soluzzjoni għall- injezzjoni ppreparata.
The contents of the pack are: • one vial of BeneFIX 500 IU powder
Il- pakkett ikun fih:
137 • one vial 5 ml sterile water • one double-ended needle • one filter spike • one ministerile infusion set • one 10 ml sterile disposable syringe for administration • two alcohol swabs • two plasters
• kunjett wieħed ta ’ trab BeneFIX 500 IU • kunjett wieħed b’ 5 ml ilma sterili għall- injezzjonijiet • labra waħda b’ żewgt itruf • ponta tal- filtru waħda • mini- sett sterili wieħed ta ’ l- infużjoni • siringa sterili waħda ta ’ 10 ml li tintrema wara li tintuża għall- għoti • żewġ biċċiet bl- alkoħol • żewġ stikek
138 139 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
130 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Tel: +39 06 927151 Fax: +39 06 23325555
Fax: +39 06 23325555
Sími: +354 540 8000 Fax: +354 540 8001
131 Suomi/ Finland Ísland Wyeth Icepharma hf.
This medicine has been authorised under “ Exceptional Circumstances”.
Din il- mediċina kienet awtorizzata taħt “ ċirkustanzi ta ’ eċċezzjoni ”.
141 PACKAGE LEAFLET:
132 FULJETT TA ’ TAGĦRIF:
- Clinical studies on BeneFIX did not determine whether patients aged 65 and over respond
133 − L- istudji kliniċi fuq BeneFIX ma stabilixxux jekk pazjenti li għandhom 65 sena jew aktar jirrispondux b’ mod differenti minn pazjenti iżgħar.
143 Taking other medicines:
134 Meta tuża mediċini oħra:
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.
Nota: il- kunjett tas- solvent
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.
135 għandha titpoġġa fuq wiċċ lixx, bħal mejda, u l- labra tiddaħħal b’ mod vertikali; i. e. b’ mod perpendikulari mal- wiċċ tat- tapp.
See Fig.
Ara l- istampa numru 2.
Attach the syringe to the adaptor (Luer) end of the infusion set.
Waħħal is- siringa mat- tarf ta ’ l- adapter (Luer) tas- sett ta ’ l- infużjoni.
145 7.
6.
8.
136 7.
In most of the cases an infusion rate with a maximum of up to 4 ml per minute was well tolerated.
Fil- maġġoranza tal- każijiet, rata ta ’ infużjoni sa ’ 4 ml kull minuta kienet tollerata sew.
BeneFIX should be injected intravenously over several minutes.
BeneFIX għandu jiġi injettat ġol- vina għal perijodu ta ’ diversi minuti.
146 Gastrointestinal disorders
Disturbi gastrointestinali
General disorders and administration site conditions
137 Disturbi ġenerali u kondizzjonijiet fil- lok ta ’ l- injezzjoni
147 Renal
Kliewi
Do not use after the expiry date stated on the outer box and vial label.
138 Tużax wara d- data ta ’ skadenza li tidher fuq il- kaxxa ta ’ barra u t- tikketta tal- kunjett.
Water for injection is also
Kull kunjett ta ’ BeneFIX nominalment fih 1000 IU nonacog alfa. − Is- sustanzi l- oħra huma: sucrose, glycine, L- histidine, polysorbate 80.
Each vial contains 100 IU of nonacog alfa
Ilma għall- injezzjonijiet hu fornut ukoll għar- rikostituzzjoni. − Wara r- rikostituzzjoni bl- ilma għall- injezzjonijiet ipprovdut, kull kunjett jkun fih 100 IU nonacog alfa f’ kull 1 ml tas- soluzzjoni għall- injezzjoni ppreparata.
per 1 ml of the prepared solution for injection.
Id- dehra ta ’ BeneFIX u d- daqs tal- pakkett
What BeneFIX looks like and contents of the pack
BeneFIX hu pprovdut bħala trab għall- injezzjoni fi kunjett tal- ħġieġ.
BeneFIX is provided as a powder for injection in a glass vial.
Il- pakkett ikun fih:
148 The contents of the pack are: • one vial of BeneFIX 1000 IU powder • one vial 10 ml sterile water for injection for reconstitution • one double-ended needle • one filter spike • one ministerile infusion set • one 10 ml sterile disposable syringe for administration • two alcohol swabs • two plasters
• kunjett wieħed ta ’ trab BeneFIX 1000 IU • kunjett wieħed b’ 10 ml ilma sterili għall- injezzjonijiet • labra waħda b’ żewgt itruf • ponta tal- filtru waħda • mini- sett sterili wieħed ta ’ l- infużjoni • siringa sterili waħda ta ’ 10 ml li tintrema wara li tintuża għall- għoti • żewġ biċċiet bl- alkoħol • żewġ stikek
Marketing Authorisation Holder:
139 Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
149 150 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
140 141 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Sími: +354 540 8000 Fax: +354 540 8001
142 Suomi/ Finland Ísland Wyeth Icepharma hf.
This leaflet was last approved in.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
152 PACKAGE LEAFLET:
143 FULJETT TA 'TAGĦRIF:
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IUpowder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX)
BeneFIX 250 IU trab u solvent għal soluzzjoni għall- injezzjoni BeneFIX 500 IU trab u solvent għal soluzzjoni għall- injezzjoni BeneFIX 1000 IU trab u solvent għal soluzzjoni għall- injezzjoni BeneFIX 2000 IU trab u solvent għal soluzzjoni għall- injezzjoni Nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti)
WHAT IS BENEFIX AND WHAT IS IT USED FOR
X’ INHU BENEFIX U GĦALXIEX JINTUŻA
BeneFIX is a coagulation factor IX product that is produced by recombinant technology.
BeneFIX hu fattur IX tal- koagulazzjoni li hu magħmul minn teknoloġija rikombinanti.
Patients with haemophilia B (Christmas disease) are deficient in coagulation factor IX.
Pazjenti bl - emofilja B (marda ta ’ Christmas) għandhom defiċjenza tal- fattur IX tal- koagulazzjoni.
BeneFIX works by replacing factor IX in haemophilia B patients to enable their blood to clot.
BeneFIX jaħdem billi jissostitwixxi l- fattur IX f’ pazjenti bl- emofilja B biex jagħmilha possibbli li d- demm tagħhom jagħqad.
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.
- See your doctor immediately if your bleeding does not stop as expected.
− Kellem lit- tabib tiegħek immedjatament jekk il- ħruġ tad- demm ma jieqafx kif mistenni.
(PTPs) receiving factor IX-containing products.
− Antikorpi li jinnewtralizzaw l- attività (inibituri) hu avveniment mhux komuni f’ pazjenti li kienu ġew ikkurati qabel (PTPs) li jkunu 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 jiġi kkurat b' BeneFIX żviluppa inibitur klinikament rilevanti ta 'rispons baxx, u billi l- esperjenza dwar l- antiġeniċità mal- fattur IX rikombinanti għadha limitata, waqt li tkun qed tiġi kkurati b’ BeneFIX, int għandek tkun immonitorjat bl - attenzjoni għall- iżvilupp ta ’ inibituri tal- fattur IX.
Sufficient data have not been
Ma nkisbitx biżżejjed informazzjoni minn
153 obtained from ongoing clinical studies on the treatment of previously untreated patients (PUPs), with BeneFIX.
144 studji kliniċi li għadhom għaddejjin dwar il- kura ta ’ pazjenti mhux kkurati qabel (previously untreated patients - PUPs), b’ BeneFIX.
- - 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.
IX inhibitor and allergic reactions.
− Kien hemm rapporti li wrew korrelazzjoni bejn in- numru ta 'każijiet ta ’ impeditur tal- fattur IX u r- reazzjonijiet allerġiċi.
- It is recommended that, whenever possible, every time you use BeneFIX, the name and batch
145 − Hu rakkomandat li, kull meta jkun possibli, kull darba li inti tieħu BeneFIX, l- isem u n- numru tal- lott tal- prodott għandhom jiġu rreġistrati.
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 (irkupru u half- life) li għandhom jiġu ċċekkjati 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.
BeneFIX is administered by intravenous (IV) injection after reconstitution of the powder for injection with the supplied solvent (0.234% w/ v sodium chloride solution) in the pre-filled syringe.
BeneFIX jingħata permezz ta ’ injezzjoni fil- vina (ġol- vina) wara r- rikostituzzjoni tat- trab għall - injezzjoni bis- solvent fornut (0. 234% soluzzjoni ta 'w/ v sodium chloride) fis- siringa mimlija għal- lest.
BeneFIX will be administered by intravenous infusion (IV) after reconstitution with sterile solvent for injection.
BeneFIX se jingħata permezz ta ’ infużjoni ġol- vina (IV) wara rikostituzzjoni b’ solvent sterili għall - injezzjoni.
Allow the vial of lyophilised BeneFIX and the pre-filled syringe to reach room temperature.
Ħalli l- kunjett ta 'BeneFIX lijofilizzat u s- siringa mimlija għal- lest biex jilħqu t- temperatura tal - kamra.
Remove the plastic flip-top cap from the BeneFIX vial to expose the central portion of the rubber stopper.
Neħħi l- għatu flip- top tal- plastik mill- kunjett ta 'BeneFIX biex tikxef il- parti ċentrali tat- tapp tal- lastku.
Wipe the top of the vial with an alcohol swab provided, or use another antiseptic solution and allow to dry.
Imsaħ il- parti ta ’ fuq tal- fjala bil- biċċa li tnaddaf bl- alkoħol ipprovduta, jew uża soluzzjoni antisettika oħra, u ħalliha tinxef.
After cleaning do not touch the rubber stopper with your hand or allow it to touch any surface.
Wara li tnaddaf, tmissx it- tapp tal- lastku b' idejk u tħallihx imiss ma 'kwalunkwe wiċċ.
Peel back the lid from the clear plastic vial adapter package.
Qaxxar lura l- għatu mill- pakkett ta 'l- adapter tal- kunjett tal- plastik ċar.
Do not remove the adapter from the package.
Tneħħix l- adapter mill - pakkett.
While holding the adapter in the package, place the vial adapter over the vial.
Filwaqt li żżomm l- adapter fil- pakkett, poġġi l- adapter tal- kunjett fuq il- kunjett.
Press down firmly on the package until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper.
Agħfas 'l isfel b' mod sod fuq il- pakkett sakemm l- adapter jikklikkja fil- post fin - naħa ta' fuq tal- kunjett, bil- ponta ta 'l- adapter li tippenetra l- għatu tal- kunjett.
Lift the package away from the adapter and discard the package.
Erfa 'l- pakkett lilhemm mill- adapter u armi l- pakkett.
Attach the plunger rod to the solvent syringe by pushing and turning firmly.
Waħħal il- lasta tal- planġer mas- siringa bis- solvent billi timbotta u ddawwar b' mod sod.
Break off the tamper-resistant plastic tip cap from the solvent syringe by snapping the perforation of the cap.
Ikser l- għatu tat- tarf tal- plastik, li hu reżistenti għat- tbagħbis, mis- siringa bis- solvent billi tqaċċat il- perforazzjoni ta 'l- għatu.
This is done by bending the cap up and down until the perforation is broken.
Dan jista 'jsir billi tilwi l- għatu' l fuq u 'l isfel sakemm il - perforazzjoni tinkiser.
Do not touch the inside of the cap or the syringe tip.
Tmissx in- naħa ta 'ġewwa ta' l- għatu jew it- tarf tas- siringa.
The cap may need to be replaced (if not administering reconstituted BeneFIX immediately), so set it aside by placing it on its top.
L- għatu jista 'jkollu bżonn jinbidel (jekk mhux ser tagħti BeneFIX rikostitwit immedjatament), allura, poġġih fil- ġenb billi tpoġġih ta' taħt fuq.
Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured.
Waħħal is- siringa bis- solvent ma 'l- adapter tal- kunjett billi ddaħħal it- tarf tas- siringa ġol- ftuħ ta' l- adapter filwaqt li timbotta b' mod sod u ddawwar is - siringa lejn il- lemin sakemm issir il- konnessjoni.
Slowly depress the plunger rod to inject all the solvent into the BeneFIX vial
Agħfas bil- mod il- lasta tal- planġer biex tinjetta s- solvent kollu ġol- kunjett ta 'BeneFIX.
With the syringe still connected to the adapter, gently rotate the vial until the powder is dissolved.
Bis- siringa għadha mwaħħla ma 'l- adapter, dawwar il- kunjett bil- mod sakemm it- trab jinħall.
The final solution should be inspected visually for particulate matter before administration.
Is- soluzzjoni finali għandha tiġi eżaminata viżwalment għal materjal f’ sura ta ’ partikuli qabel ma tingħata.
The solution should appear clear and colourless.
Is- soluzzjoni għandha tidher ċara u bla kulur.
If you use more than one vial of BeneFIX per infusion, each vial should be reconstituted as per the previous instructions.
Jekk tuża iktar minn kunjett wieħed ta 'BeneFIX għal kull infużjoni, kull kunjett għandha tiġi rikostitwita skond l- istruzzjonijiet li ngħataw qabel.
The solvent syringe should be removed, leaving the vial adapter in place, and a separate large luer lock syringe may be used to draw back the reconstituted contents of each individual vial.
Is- siringa bis- solvent għandha titneħħa, filwaqt li tħalli l- adapter tal- kunjett f' postu, u siringa luer lock kbira separata tista 'tintuża biex tiġbed lura il- kontenut rikostitwit ta' kull kunjett individwali.
Ensuring that the syringe plunger rod is still fully depressed, invert the vial.
Filwaqt li taċċerta ruħek li l- lasta tal- planġer tas- siringa għada magħfus kollu 'l isfel, aqleb il - kunjett.
Slowly draw back all the solution into the syringe.
Iġbed bil- mod is- soluzzjoni kollha ġos- siringa.
Detach the syringe from the vial adapter by gently pulling and turning the syringe counter- clockwise.
Aqla 's- siringa mill- adapter tal- kunjett billi tiġbed u ddawwar is- siringa bil- mod lejn ix- xellug.
Discard the vial with the adapter attached.
Armi l- kunjett bl- adapter imwaħħal.
If the solution is not to be used immediately, the syringe cap should be carefully replaced.
Jekk is- soluzzjoni ma tkunx ser tintuża immedjatament, l- għatu tas- siringa għandu jitpoġġa f' postu bl- attenzjoni.
Do not touch the syringe tip or the inside of the cap.
Tmissx it- tarf tas- siringa jew in- naħa ta 'ġewwa ta' l- għatu.
Administration (Intravenous Injection):
148 Għoti (Injezzjoni ġol- vina):
BeneFIX should be administered using the pre-filled solvent syringe provided or a single sterile disposable plastic luer lock syringe.
BeneFIX għandu jingħata bl- użu tas- siringa mimlija għal- lest bis- solvent ipprovduta, jew b’ siringa sterili luer lock tal- plastik waħda, li tintrema wara li tintuża.
In addition, the solution should be withdrawn from the vial using the vial adapter.
Barra minn hekk, is- soluzzjoni għandha tinġibed mill- kunjett bl- użu ta 'l- adapter tal- kunjett.
BeneFIX should be injected intravenously over several minutes.
BeneFIX għandu jiġi injettat ġol- vina għal perijodu ta 'diversi minuti.
Your doctor may change your recommended infusion rate to make the infusion more comfortable.
It- tabib tiegħek jista ’ jibdel ir - rata ta 'infużjoni rakkomandata tiegħek biex jagħmel l- infużjoni iktar komda.
Please dispose of all unused solution, empty vials and used needles and syringes in an appropriate container for throwing away waste as it may hurt others if not handled properly.
Jekk jogħġbok armi s- soluzzjoni kollha li ma ntużatx, fjali vojta, labar u siringi użati f’ kontenitur xieraq għal rimi ta ’ skart, għax dawn jistgħu jweġġħu lil ħaddieħor jekk ma jkunux immaniġġjati kif suppost.
If you have any further questions on the use of this product, ask your physician or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqst lit- tabib jew lill- ispiżjar tiegħek.
158 Possible side effects are listed according to the following categories:
Rari:
Uncommon: between 1 in 100 and 1 in 1,000 patients Rare: between 1 in 1,000 and 1 in 10,000 patients
bejn 1 f’ 100 u 1 f ’ 1, 000 pazjent bejn 1 f ’ 1, 000 u 1 f’ 10, 000 pazjent
General disorders and administration site conditions
149 Disturbi ġenerali u kondizzjonijiet fil- lok ta ’ l- injezzjoni
Injection site reactions (including burning and stinging at the infusion site), discomfort at the IV site, cellulites, phlebitis
Reazzjonijiet fejn issir l- injezzjoni (inkluż ħruq u tingiż fil- post ta ’ l- infużjoni), skumdità fil- post ġol- vina, ċellulite, flebite
* See additional information below.
* Ara aktar informazzjoni hawn taħt.
Hypersensitivity or allergic reactions have been infrequently observed in patients treated with factor IX containing products, including BeneFIX.
Reazzjonijiet ta ’ sensittività eċċessiva jew reazzjonijiet allerġiċi kienu osservati b’ mod rari f’ pazjenti li kienu qed jiġu kkurati bi prodotti tal- fattur IX, inkluż BeneFIX.
Allergic reactions have occurred in close temporal association with development of factor IX inhibitor (see also “ Take special care with BeneFIX ”).
Reazzjonijiet allerġiċi dehru f’ assoċjazzjoni temporanja fil- qrib ma ’ l - iżvilupp ta ’ impeditur tal- fattur IX (ara wkoll “ Oqgħod attent ħafna b' BeneFIX ”).
These reactions are potentially life-threatening.
Dawn ir- reazzjonijiet ta ’ theddida potenzjali għall- ħajja.
The treatment required depends on the nature and severity of side-effects (see also “ Take special care with BeneFIX ”).
Il- kura li jkun hemm bżonn tiddependi minn natura u s- serjetà ta ’ l - effetti kollaterali (ara wkoll “ Oqgħod attent ħafna b' BeneFIX ”).
Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Pazjenti b’ emofilija B jistgħu jiżviluppaw antikorpi li jinnewtralizzaw (inibituri) għall- fattur IX.
If such inhibitors occur, the condition may manifest itself as an insufficient clinical response.
Jekk dawn l- inibituri jseħħu, il- kundizzjoni tista ’ tidher bħala rispons kliniku insuffiċjenti.
In such cases, it is recommended that a specialised haemophilia centre be contacted.
F' każijiet bħal dawn, hu rakkomandat li ċentru speċjalizzat ta 'l- emofilja jiġi kkuntattjat.
Patients treated with BeneFIX should be monitored for inhibitor development.
Pazjenti kkurati b' BeneFIX, għandhom ikunu mmonitorjat għall- iżvilupp ta 'l- inibitur.
159 There are insufficient data to provide information on inhibitor incidence in previously untreated patients (PUPs).
M’ hemmx biżżejjed informazzjoni sabiex jiġi fornut tagħrif fuq l- inċidenza ta ’ l- impeditur fil- pazjenti li ma kienux ikkurati qabel.
Due to the production process BeneFIX may contain trace amounts of hamster cell proteins.
Minħabba l- proċess ta ’ produzzjoni BeneFIX jista ’ jkun fih traċċi ta ’ proteini tal- ħamsters.
A kidney disorder 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 (see also “ Take special care with BeneFIX ”).
Kien hemm rapporti ta ’ disturbi fil- kliewi, wara dożi qawwija ta ’ Fattur IX derivat mill- plażma, għal tolleranza immuni f’ pazjenti li jbatu bl- emofilja B għall- impedituri tal- fattur IX u li kellhom reazzjonijiet allerġiċi fil- passat (ara wkoll “ Oqgħod attent ħafna b' BeneFIX ”).
One patient developed severe abdominal pain which was caused by an area of the kidney that lacked the necessary blood supply (referred to as a renal infarct).
Pazjent qabdu uġigħ qawwi fl- addome li kien ikkaġunat minn parti fil- kliewi li ma kellhiex l- provvista ta 'demm meħtieġ (magħruf bħala infart tal- kliewi).
Do not use after the expiry date stated on the outer box and vial label.
Tużax wara d- data ta ’ skadenza li tidher fuq il- kaxxa ta 'barra u t- tikketta tal- kunjett.
Do not use BeneFIX if the solution is not clear or colourless.
Tużax BeneFIX jekk is- soluzzjoni ma tkunx ċara u bla kulur.
Do not store above 25ºC.
150 Taħżinx f’ temperatura ’ l fuq minn 25°C.
BeneFIX must be stored continuously in a refrigerator at a temperature of 2°C to 8°C and must be used by the expiry date on the label.
BeneFIX għandu jinħażen kontinwament fi friġġ (2°C sa 8°C) u għandu jintuża sad- data ta ’ skadenza li jkun hemm fuq it- tikketta.
For the purpose of ambulatory use the product may be removed from such storage for one single period of maximum 1 month at room temperature (up to 25°C).
Għall- għan ta ’ użu fi klinika, il- prodott jista ’ jinħareġ minn fejn ikun maħżun għal perijodu wieħed sa massimu ta 'xahar, u jinżamm fit- temperatura tal- kamra (sa 25ºC).
Do not freeze in order to prevent damage to the pre-filled syringe.
Tagħmlux fil- friża, biex ma ssirx ħsara lis- siringa mimlija għal- lest.
Use the reconstituted solution immediately or within 3 hours.
Uża s- soluzzjoni rikostitwita immedjatament, jew fi żmien 3 sigħat.
contains nominally 250, 500, 1000 or 2000 IU of nonacog alfa.
Kull kunjett ta 'BeneFIX nominalment fih 250, 500, 1000 jew 200 IU ta' nonacog alfa. − Is- sustanzi l- oħra huma sucrose, glycine, L- histidine, polysorbate 80.
- After reconstitution with the supplied solvent (0.234% sodium chloride solution), each vial contains
Solvent (soluzzjoni ta '0. 234% sodium chloride) hi fornuta wkoll għar- rikostituzzjoni. − Wara r- rikostituzzjoni bis- solvent ipprovdut (soluzzjoni ta' 0. 234% sodium chloride), kull kunjett fih 50, 100, 200 jew 400 IU (ara Tabella 1).
50, 100, 200 or 400 IU/ ml (see Table 1).
Tabella 1.
Strength of BeneFIX per ml prepared solution
Il- qawwa ta ’ BeneFIX għal kull 1 ml ta ’ soluzzjoni ppreparata
Amount of BeneFIX per Vial
Ammont ta ’ BeneFIX f’ kull Kunjett
Amount of BeneFIX per 1 ml of prepared solution for injection
Ammont ta ’ BeneFIX f’ kull 1 ml ta ’ soluzzjoni ppreparata għall- injezzjoni
What BeneFIX looks like and contents of the pack
Id- dehra ta 'BeneFIX u d- daqs tal- pakkett
BeneFIX is provided as a powder for injection in a glass vial and a solvent provided in pre-filled syringe.
BeneFIX hu pprovdut bħala trab għall- injezzjoni fi kunjett tal- ħġieġ u solvent ipprovdut f' siringa mimlija għal- lest.
• one vial of BeneFIX 250, 500 1000 or 2000 IU powder • 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
• kunjett wieħed ta 'trab BeneFIX 250, 500, 1000 jew 2000 IU • 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 wieħed tal- kunjett tat- tagħmir tar- rikostituzzjoni • sett sterili wieħed ta ’ l- infużjoni • żewġ biċċiet bl- alkoħol • stikka waħda
161 Manufacturer
Manifattur
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
152 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
België/ Belgique/ Belgien Luxembourg/ Luxemburg Wyeth Pharmaceuticals S. A. / N. V.
Luxembourg/ Luxemburg Tel: +39 06 927151 Wyeth Pharmaceuticals S. A. / N. V.
Tél/ Tel: +32 10 49 47 11 Fax: +32 10 49 48 70
Fax: +39 06 23325555 Tél/ Tel: +32 10 49 47 11 Fax: +32 10 49 48 70
Tel: +39 06 927151 Fax: +39 06 23325555
Česká Republika Wyeth Whitehall Czech s. r. o.
Č eská Republika Wyeth Whitehall Czech s. r. o.
Kύπρος Wyeth Hellas (Cyprus Branch) AEBE
България / Eesti/ Latvija/ Lietuva/ Österreich / România/ Slovenija Wyeth-Lederle Pharma GmbH Tel/ Tãlr: +43 1 89 1140 Faks/ Fakss/ Faksas/ Fax: +43 1 89 114600
България/ Eesti/ Latvija/ Lietuva / Österreich / România / Slovenija
Sími: +354 540 8000 Fax: +354 540 8001
Suomi/ Finland Ísland Wyeth Icepharma hf.
Suomi/ Finland Wyeth Puh/ Tel: +358 20 7414 870 Fax: +358 20 7414 879
Puh/ Tel: +358 20 7414 870 Simi: +354 540 8000 Fax: +358 20 7414 879 Fax: +354 540 8001
This leaflet was last approved in.
Dan il- fuljett kien approvat l- aħħar fi {XX/ SSSS}.
What is Beromun?
X’ inhu Beromun?
Beromun is a powder and solvent that are made up into a solution for infusion.
Beromun hu trab u solvent li jitħalltu biex jiffurmaw soluzzjoni għall- infużjoni.
It contains the active substance tasonermin.
Fih is- sustanza attiva tasonermin.
What is Beromun used for?
Għal xiex jintuża Beromun?
Beromun is used in patients with soft tissue sarcoma (a type of cancer) of the limb (arm or leg), together with melphalan (an anticancer medicine), using a technique called ‘ isolated limb perfusion’ (ILP): both medicines are injected into the limb while the blood circulation in the limb is kept isolated (cut off) from the rest of the body.
Beromun jintuża f’ pazjenti b’ sarkoma (tip ta ’ kanċer) fit- tessut artab fir- riġel jew fid- driegħ, flimkien ma ’ melphalan (mediċina ta ’ kontra l- kankru), bl- użu ta ’ teknika magħrufa bħala ‘ perfużjoni iżolata fid- driegħ jew fir- riġel ’ (ILP): iż- żewġ mediċini jiġu injettati fid- driegħ jew fir- riġel waqt li ċ - ċirkulazzjoni tad- demm tinżamm iżolata (maqtugħa) mill- bqija tal- ġisem.
It can be used before surgery to reduce the size of a tumour, or instead of surgery when the tumour cannot be removed by surgery alone.
Jista ’ jintuża qabel operazzjoni biex inaqqas id- daqs ta ’ tumur, jew minflok operazzjoni meta t- tumur ma jkunx jista ’ jitneħħa b’ operazzjoni biss.
How is Beromun used?
Kif jintuża Beromun?
Beromun treatment should only be carried out in special centres by surgical teams who have experience in the treatment of this type of cancer and ILP.
It- trattament b’ Beromun għandu jsir f’ ċentri speċjali minn timijiet tal- kirurġija li jkollhom esperjenza fit- trattament ta ’ dan it- tip ta ’ kankru u tal- ILP.
The centres must also have intensive care units readily available and facilities to continuously look out for leakage of the medicine into the rest of the body using radioactive tracers.
Iċ- ċentri jrid ikollhom ukoll taqsimiet tal- kura intensiva lesti u faċilitajiet biex issir sorveljanza kontinwa għall- ħruġ ta ’ mediċini għall- bqija tal - ġisem bl- użu ta ’ tracers radjuattivi.
Before Beromun is given, the limb is first isolated: while the patient is under general anaesthetic, a tight band is placed around the top of the limb to isolate its blood supply and prevent the medicine reaching the rest of the body.
Qabel jingħata Beromun, ir- riġel jew id- driegħ għall- ewwel jiġi iżolat: waqt li l- pazjent ikun taħt il - loppju ġenerali, titqiegħed qafla ssikkata madwar il- parti ta ’ fuq tad- driegħ jew riġel biex tiżola l - provvista tad- demm u tipprevjeni l- mediċina milli tilħaq il- bqija tal- ġisem.
The blood circulation in the limb is then replaced by the ‘ perfusion ’ of a special liquid and the limb is warmed to a temperature of between 38 and 39°C.
Iċ- ċirkulazzjoni fir- riġel jew fid- driegħ tiġi rimpjazzata minn ‘ perfużjoni ’ ta ’ likwidu speċjali u r- riġel jew driegħ jissaħħan għal temperatura ta ’ bejn 38 u 39°C.
Beromun is then injected into the perfusion solution at a dose of 3 mg for an arm and 4 mg for a leg, given over 90 minutes.
Beromun imbagħad jiġi injettat fis- soluzzjoni tal- perfużjoni b’ doża ta ’ 3 mg għal driegħ u 4 mg għal riġel, fuq perjodu ta ’ 90 minuta.
Melphalan is given during the same operation over 60 minutes, beginning 30 minutes after the start of the Beromun perfusion, when the temperature should be increased to 39 to 40°C.
Melphalan jingħata waqt l - istess operazzjoni fuq perjodu ta ’ 60 minuta, li jibdew 30 minuta wara il- bidu tal- perfużjoni ta ’ Beromun meta t- temperatura għandha tiżdied għal bejn 39 u 40°C.
The dose of melphalan depends on the size of the arm or leg.
Id- doża ta ’ melphalan tiddependi mid- daqs tad- driegħ jew riġel.
At the end of the 90-minute procedure, the medicines are flushed out of the limb using a suitable fluid.
Fi tmiem il- proċedura ta ’ 90 minuta, il- mediċina tiġi mbuttata ’ l barra mid- driegħ jew riġel bl- użu ta ’ fluwidu stabbli.
The remains of the tumour should be removed whenever this is possible, usually after several weeks.
Il- fdalijiet tat- tumur għandhom jitneħħew meta dan ikun possibbli, ġeneralment wara ħafna ġimgħat.
Beromun is usually only used once, but a second perfusion can be considered six to eight weeks after the first.
Beromun ġeneralment jintuża darba biss, iżda t- tieni perfużjoni tista ’ tiġi kkunsidrata bejn sitta u tmien ġimgħat wara l- ewwel waħda.
Beromun is not recommended for patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.
Beromun mhux rakkomandat għal pazjenti taħt it- tmintax- il sena, minħabba nuqqas ta ’ tagħrif dwar is- sigurtà u l- effikaċja f’ dan il- grupp.
How does Beromun work?
Kif jaħdem Beromun?
The active substance in Beromun, tasonermin, is a copy of the human protein tumour necrosis factor alfa-1a (TNF α).
Is- sustanza attiva f’ Beromun, tasonermin, hija kopja tal- proteina umana magħrufa bħala l- fattur tan - nekrożi tat- tumur alfa- 1a (TNFα).