qanastek/EMEA-V3 huggingface dataset:
After reconstitution, each ml of solution contains approximately 62.5 IU moroctocog alfa.
Wara r- rikostituzzjoni, kull ml ta ’ soluzzjoni jkun fih madwar 62. 5 IU ta ’ moroctocog alfa.
Read the package leaflet before use.
Sucrose, calcium chloride dihydrate, L- histidine, polysorbate 80, sodium chloride Aqra l- fuljett ta ’ tagħrif qabel l- użu.
1 vial with 250 IU moroctocog alfa 1 pre-filled syringe with 4 ml sterile Solvent 1 Vial Adapter 1 Sterile Infusion Set 2 Alcohol Swabs 1 Plaster 1 Gauze
1 kunjett b ’ 250 IU ta ’ moroctocog alfa 1 siringa mimlija għal- lest b’ 4 ml ta ’ Solvent sterilizzat 1 Adapter għall- Kunjett 1 Sett Sterilizzat għall- Infużjoni 2 Swabs bl- Alkoħol 1 Stikka 1 Garża
Intravenous use, after reconstitution.
Użu għal ġol- vini, wara r- rikostituzzjoni.
Do not use after expiry date
52 Tużax wara d- data ta ’ meta jiskadi
Use immediately or within 3 hours of reconstitution.
Uża immedjatament jew fiż- żmien 3 sigħat wara r- rikostituzzjoni.
Do not freeze
Aħżen u ġorr f’ temperatura ta ’ bejn 2°C – 8°C Tagħmlux fil- friża
Keep the vial in the original package in order to protect from light.
Żomm il- kunjett fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
ReFacto AF can be stored at room temperature (up to 25oC) for a single period up to 3 months.
ReFacto AF jista ’ jinħażen f’ temperatura tal- kamra (sa 25oC) għal darba biss sa 3 xhur.
The product may not be returned to refrigerated storage after storage at room temperature.
Il- prodott m’ għandux jerġa ’ jinħażen fil- friġġ wara li jkun ħa t- temperatura tal- kamra.
Date removed from the refrigerator:
Data ta ’ meta nħareġ mill- friġġ:
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR - RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART DERIVAT MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
Discard any remaining reconstituted solution
Armi kwalunkwe soluzzjoni rikostitwita li jibqa ’.
Wyeth Europa Ltd Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom
Wyeth Europa Ltd Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH Ir- Renju Unit
49 Medicinal product subject to medical prescription.
Prodott mediċinali jingħata bir- riċetta tat- tabib.
REFACTO AF TRAY LID
L- GĦATU TAT- TREJ TA ’ REFACTO AF
ReFacto AF 250 IU powder and solvent for solution for injection Moroctocog alfa
ReFacto AF 250 IU trab u solvent għal soluzzjoni għall- injezzjoni Moroctocog alfa
Intravenous use Read the package leaflet before use Keep this container in the outer carton Store in a refrigerator
Użu għal ġol- vini Aqra l- fuljett ta ’ tagħrif qabel l- użu Żomm dan il- kontenitur fil- kartuna ta ’ barra Aħżen fi friġġ
51 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
55 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
REFACTO AF VIAL LABEL
TIKKETTA TAL- KUNJETT TA ’ REFACTO AF
ReFacto AF 250 IU powder for solution for injection Moroctocog alfa IV use
ReFacto AF 250 IU trab għal soluzzjoni għall- injezzjoni Moroctocog alfa Użu għal ġol- vini
REFACTO AF SOLVENT PRE-FILLED SYRINGE LABEL
TIKKETTA TAS- SIRINGA MIMLIJA GĦAL- LEST BIS- SOLVENT TA ’ REFACTO AF
Solvent for ReFacto AF
Solvent għal ReFacto AF
IV use, after reconstitution.
Użu għal ġol- vini, wara r- rikostituzzjoni.
Contains 4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection
Fih 4 ml ta ’ 9 mg/ ml (0. 9%) sodium chloride għal soluzzjoni għall- injezzjoni
ReFacto AF 500 IU powder and solvent for solution for injection Moroctocog alfa (recombinant human coagulation factor VIII)
ReFacto AF 500 IU trab u solvent għal soluzzjoni għall- injezzjoni Moroctocog alfa (fattur VIII tal- koagulazzjoni rikombinanti uman)
One vial contains 500 IU moroctocog alfa.
Kunjett wieħed fih 500 IU ta ’ moroctocog alfa.
After reconstitution, each ml of solution contains approximately 125 IU moroctocog alfa.
Wara r- rikostituzzjoni, kull ml ta ’ soluzzjoni jkun fih madwar 125 IU ta ’ moroctocog alfa.
1 vial with 500 IU moroctocog alfa 1 pre-filled syringe with 4 ml sterile Solvent 1 Vial Adapter 1 Sterile Infusion Set 2 Alcohol Swabs 1 Plaster 1 Gauze
1 kunjett b’ 500 IU ta ’ moroctocog alfa 1 siringa mimlija għal- lest b’ 4 ml ta ’ Solvent sterilizzat 1 Adapter għall- Kunjett 1 Sett Sterilizzat għall- Infużjoni 2 Swabs bl- Alkoħol 1 Stikka 1 Garża
Do not use after expiry date
Tużax wara d- data ta ’ meta jiskadi
56 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS REFACTO AF TRAY LID
60 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ReFacto AF 500 IU powder and solvent for solution for injection Moroctocog alfa
ReFacto AF 500 IU trab u solvent għal soluzzjoni għall- injezzjoni Moroctocog alfa
57 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
61 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ReFacto AF 500 IU powder for solution for injection Moroctocog alfa IV use
ReFacto AF 500 IU trab għal soluzzjoni għall- injezzjoni Moroctocog alfa Użu għal ġol- vini
58 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
62 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ReFacto AF 1000 IU powder and solvent for solution for injection Moroctocog alfa (recombinant human coagulation factor VIII)
ReFacto AF 1000 IU trab u solvent għal soluzzjoni għall- injezzjoni Moroctocog alfa (fattur VIII tal- koagulazzjoni rikombinanti uman)
One vial contains 1000 IU moroctocog alfa.
Kunjett wieħed fih 1000 IU ta ’ moroctocog alfa.
After reconstitution, each ml of solution contains approximately 250 IU moroctocog alfa.
Wara r- rikostituzzjoni, kull ml ta ’ soluzzjoni jkun fih madwar 250 IU ta ’ moroctocog alfa.
1 vial with 1000 IU moroctocog alfa 1 pre-filled syringe with 4 ml sterile Solvent 1 Vial Adapter 1 Sterile Infusion Set 2 Alcohol Swabs 1 Plaster 1 Gauze
1 kunjett b’ 1000 IU ta ’ moroctocog alfa 1 siringa mimlija għal- lest b’ 4 ml ta ’ Solvent sterilizzat 1 Adapter għall- Kunjett 1 Sett Sterilizzat għall- Infużjoni 2 Swabs bl- Alkoħol 1 Stikka 1 Garża
61 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
65 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ReFacto AF 1000 IU powder and solvent for solution for injection Moroctocog alfa
ReFacto AF 1000 IU trab u solvent għal soluzzjoni għall- injezzjoni Moroctocog alfa
62 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
66 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ReFacto AF 1000 IU powder for solution for injection Moroctocog alfa IV use
ReFacto AF 1000 IU trab għal soluzzjoni għall- injezzjoni Moroctocog alfa Użu għal ġol- vini
63 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
67 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ReFacto AF 2000 IU powder and solvent for solution for injection Moroctocog alfa (recombinant human coagulation factor VIII)
ReFacto AF 2000 IU trab u solvent għal soluzzjoni għall- injezzjoni Moroctocog alfa (fattur VIII tal- koagulazzjoni rikombinanti uman)
One vial contains 2000 IU moroctocog alfa.
Kunjett wieħed fih 2000 IU ta ’ moroctocog alfa.
After reconstitution, each ml of solution contains approximately 500 IU moroctocog alfa.
Wara r- rikostituzzjoni, kull ml ta ’ soluzzjoni jkun fih madwar 500 IU ta ’ moroctocog alfa.
1 vial with 2000 IU moroctocog alfa 1 pre-filled syringe with 4 ml sterile Solvent 1 Vial Adapter 1 Sterile Infusion Set 2 Alcohol Swabs 1 Plaster 1 Gauze
1 kunjett b’ 2000 IU ta ’ moroctocog alfa 1 siringa mimlija għal- lest b’ 4 ml ta ’ Solvent sterilizzat 1 Adapter għall- Kunjett 1 Sett Sterilizzat għall- Infużjoni 2 Swabs bl- Alkoħol 1 Stikka 1 Garża
65 Medicinal product subject to medical prescription.
Prodott mediċinali jingħata bir- riċetta tat- tabib.
66 MINIMUM PARTICULARS TO APPEAR BLISTERS OR STRIPS
70 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ReFacto AF 2000 IU powder and solvent for solution for injection Moroctocog alfa
ReFacto AF 2000 IU trab u solvent għal soluzzjoni għall- injezzjoni Moroctocog alfa
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
71 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ReFacto AF 2000 IU powder for solution for injection Moroctocog alfa IV use
ReFacto AF 2000 IU trab għal soluzzjoni għall- injezzjoni Moroctocog alfa Użu għal ġol- vini
69 PACKAGE LEAFLET:
73 FULJETT TA ’ TAGĦRIF:
ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection Moroctocog alfa (recombinant human coagulation factor VIII)
ReFacto AF 250 IU trab u solvent għal soluzzjoni għall- injezzjoni ReFacto AF 500 IU trab u solvent għal soluzzjoni għall- injezzjoni ReFacto AF 1000 IU trab u solvent għal soluzzjoni għall- injezzjoni ReFacto AF 2000 IU trab u solvent għal soluzzjoni għall- injezzjoni Moroctocog alfa (fattur VIII tal- koagulazzjoni rikombinanti uman)
You may need to read it again.
Jista ’ jkollok bżonn terga ’ taqrah.
if their symptoms are the same as yours.
il- ħsara anke jekk ikollhom l- istess sintomi bħal tiegħek.
- If you are concerned about any side effects or if you notice any side effects not listed in this
- Jekk qed tinkwieta dwar xi wieħed mill- effetti sekondarji, jew jekk tinnota xi effetti sekondarji
leaflet, please tell your doctor or pharmacist.
minbarra dawk imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What ReFacto AF is and what it is used for 2.
X’ inhu ReFacto AF u għalxiex jintuża 2.
Before you use ReFacto AF 3.
Qabel ma tuża ReFacto AF 3.
How to use ReFacto AF 4.
Kif għandek tuża ReFacto AF 4.
Possible side effects 5 How to store ReFacto AF 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen ReFacto AF 6.
WHAT REFACTO AF IS AND WHAT IT IS USED FOR
X’ INHU REFACTO AF U GĦALXIEX JITUŻA
ReFacto AF contains the active substance moroctocog alfa, human coagulation factor VIII produced by recombinant DNA technology.
ReFacto AF fih is- sustanza attiva moroctocog alfa, fattur VIII tal- koagulazzjoni umana, magħmula minn teknoloġija tad- DNA rikombinanti.
Factor VIII is necessary for the blood to form clots and stop bleedings.
Il- fattur VIII hu meħtieġ għad- demm biex jifforma emboli u jwaqqaf il- ħruġ tad- demm.
In patients with haemophilia A (inborn factor VIII deficiency), it is missing or not working properly.
F’ pazjenti b’ emofilja A (defiċjenza ta ’ fattur VIII mit- twelid), dan ikun nieqes jew ma jkunx jaħdem kif suppost.
ReFacto AF is used for the treatment and prevention of bleeding (prophylaxis) in adults and children of all ages (including newborns) with haemophilia A.
Refacto AF jintuża għall- kura u l- prevenzjoni ta ’ emorraġiji (profilassi) fl- adulti u t- tfal ta ’ kull età (li jinkludu trabi tat- twelid) b’ emolfilja A.
ReFacto AF does not contain von Willebrand factor, and hence is not indicated in von Willebrand’s disease.
ReFacto AF m’ għandux il- fattur von Willebrand u għalhekk mhux indikat biex jintuża fil- marda von Willebrand.
BEFORE YOU USE REFACTO AF
QABEL MA TUŻA REFACTO AF
Do not use ReFacto AF
Tużax ReFacto AF
- if you are allergic (hypersensitive) to moroctocog alfa or any of the other ingredients of ReFacto
- jekk inti allerġiku (tbati minn sensittività eċċessiva) għal moroctocog alfa jew sustanzi oħra ta ’
AF (listed in section 6).
ReFacto AF (elenkati f’ sezzjoni 6).
- if you are hypersensitive to hamster proteins.
- jekk tbati minn sensittività eċċessiva għall- proteini tal- ħamster.
Take special care with ReFacto AF
Oqgħod attent ħafna b’ ReFacto AF
- if you experience allergic reactions.
- jekk ikollok reazzjonijiet allerġiċi.
Some of the signs of allergic (hypersensitivity) reactions are
Xi wħud mis- sinjali ta ’ reazzjonijiet allerġiċi (sensittività
difficulty in breathing, shortness of breath, swelling, hives, itching, tightness of the chest, wheezing, and low blood pressure.
eċċessiva) huma diffikultà biex tieħu n- nifs, qtugħ ta ’ nifs, nefħa, urtikarja, ħakk, tagħfis fis - sider, tħarħir, u pressjoni tad- demm baxxa.
Anaphylaxis is a severe allergic reaction that can cause difficulty in swallowing and/or breathing, red or swollen face and/or hands.
74 tikkawża diffikultà biex tibla ’ u/ jew biex tieħu n- nifs, wiċċ jew idejn ħomor/ minfuħ.
If any of these signs occur, stop the infusion immediately and contact a doctor or seek immediate emergency care.
Jekk kwalunkwe minn dawn is- sinjali jseħħu, waqqaf l- infużjoni immedjatament u ikkuntattja tabib jew fittex kura ta ’ emerġenza minnufih.
In case of severe allergic reactions, alternative therapy must be considered.
F’ każ ta ’ reazzjonijiet allerġiċi serji, terapija alternattiva trid tiġi kkunsidrata.
- if your bleeding does not stop as expected and contact your doctor or seek immediate
- jekk l- emorraġija ma tiqafx kif mistenni, ikkuntattja lit- tabib tiegħek jew fittex kura ta ’
emergency care.
emerġenza minnufih.
- if bleeding is not adequately controlled with the usual dose.
- jekk l- emorraġija ma tkunx ikkontrollata kif suppost bid- doża tas- soltu.
Patients receiving factor VIII
Il- pazjenti li jirċievu
products may sometimes develop antibodies to factor VIII (also known as factor VIII inhibitors), which may prevent the factor VIII product from working properly.
prodotti ta ’ fattur VIII jistgħu xi kultant jiżviluppaw antikorpi għal fattur VIII (magħrufa wkoll bħala inibituri ta ’ fattur VIII), li jistgħu ma jħallux lill- prodott ta ’ fattur VIII milli jaħdem kif suppost.
While being treated with ReFacto AF, you should be monitored for the development of factor VIII inhibitors.
Meta tkun qed tiġi kkurat b’ ReFacto AF, għandek tkun immonitorjat għall- iżvilupp ta ’ inibituri ta ’ fattur VIII.
- if you are elderly.
- jekk inti persuna anzjana.
Your doctor may change the dose.
It- tabib tiegħek jista ’ jibdel id- doża.
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Tell your doctor if you are pregnant or breast-feeding.
Għid lit- tabib tiegħek jekk inti tqila jew jekk qed tredda ’.
Your doctor will decide if ReFacto AF may be used during pregnancy and breast-feeding.
It- tabib tiegħek ser jiddeċiedi jekk ReFacto AF jistax jintuża matul it- tqala u t- treddigħ.
Important information about some of the ingredients of ReFacto AF
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ ReFacto AF
This medicinal product contains 1.23 mmol (or 29 mg) sodium per vial of reconstituted powder.Inform your doctor if you are on a controlled sodium diet.
Informa lit- tabib tiegħek jekk qiegħed/ qegħda fuq dieta kkontrollata tal- melħ.
HOW TO USE REFACTO AF
KIF GĦANDEK TUŻA REFACTO AF
Always take ReFacto AF exactly as your doctor has instructed you.
Dejjem għandek tuża ReFacto AF skond il- parir tat- tabib tiegħek.
Your doctor will decide the dose of ReFacto AF you will receive.
It- tabib tiegħek ser jiddeċiedi d- doża ta ’ ReFacto AF li għandek tieħu.
This dose and duration will depend upon your individual needs for replacement factor VIII therapy.
Din id- doża u t- tul ta ’ żmien kemm għandha ddum tittieħed tiddependi fuq il- bżonnijiet individwali tiegħek għat- terapija ta ’ sostituzzjoni ta ’ fattur VIII.
During your treatment, your doctor may decide to change the dose of ReFacto AF you receive.
Waqt il- kura tiegħek, it- tabib tiegħek jista ’ jiddeċiedi li jbiddel id- doża ta ’ ReFacto AF li tirċievi.
Consult with your health care provider before you travel.
Kellem lill- fornitur tal- kura tas- saħħa tiegħek qabel ma tivvjaġġa.
You should bring enough of your factor VIII product for anticipated treatment when travelling.
Għandek tieħu miegħek biżżejjed prodott ta ’ fattur VIII għall- kura antiċipata meta tivvjaġġa.
It is recommended that every time you use ReFacto AF, you record the name on the carton and batch number of the product.
Hu rakkomandat li kull meta meta tuża ReFacto AF, tikteb l- isem fuq il- kartuna u n- numru tal- lott tal - prodott.
You can use one of the peel-off labels found on the vial to document the batch number in your diary or for reporting any side effects.
Tista ’ tuża waħda mit- tikketti li jistgħu jinqalgħu li hemm fuq il- kunjett biex tikteb in- numru tal- lott fid- djarju tiegħek jew biex tirrapporta xi effetti sekondarji.
Reconstitution and administration
Rikostituzzjoni u għoti
71 The procedures below are provided as guidelines for the reconstitution and administration of ReFacto AF.
75 Il- proċeduri ta ’ hawn taħt huma pprovduti bħala gwida għar- rikostituzzjoni u l- għoti ta ’ ReFacto AF.
Patients should follow the specific reconstitution and administration procedures provided by their doctors.
Il- pazjenti għandhom isegwu l- proċeduri speċifiċi tar- rikostituzzjoni u ta ’ l- għoti pprovduti lilhom mit- tobba tagħhom.
Use only the pre-filled syringe provided in the box for reconstitution.
Uża s- siringa mimlija għal- lest biss, ipprovduta fil- kaxxa għar- rikostituzzjoni.
Other sterile disposable syringes may be used for administration.
Għall- għoti, jistgħu jintużaw siringi sterili oħrajn li jintremew wara li jintużaw.
ReFacto AF is administered by intravenous (IV) injection after reconstitution of the lyophilised powder for injection with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution] syringe.
ReFacto AF jingħata ġol- vina (IV) permezz ta ’ injezzjoni wara r- rikostituzzjoni tat- trab lajofilizzat għall- injezzjoni bis- solvent ipprovdut fis- siringa [soluzzjoni ta ’ 9 mg/ ml (0. 9%) sodium chloride].
ReFacto AF should not be mixed with other infusion solutions.
ReFacto AF m’ għandux jiġi mħallat ma soluzzjonijiet ta ’ infużjoni oħra.
Always wash your hands before performing the following reconstitution and administration procedures.
Dejjem aħsel idejk qabel tibda l- proċeduri tar- rikostituzzjoni u ta ’ l- għoti.
Aseptic technique (meaning clean and germ-free) should be used during the reconstitution procedure.
Teknika asettika (li tfisser indafa u ħielsa mill- mikrobi) għandha dejjem tkun użata fil- proċedura ta ’ rikostituzzjoni.
Allow the vial of lyophilised ReFacto AF and the pre-filled solvent syringe to reach room temperature.
Ħalli l- kunjetti ta ’ ReFacto AF imnixxef permezz ta ’ friża u siringa ppreparata bis- solvent jilħqu t- temperatura tal- kamra.
Remove the plastic flip-top cap from the ReFacto AF vial to expose the central portion of the rubber stopper.
Neħħi t- tapp tal- plastik li jinfetaħ billi tgħolliħ mill- kunjett ta ’ ReFacto AF, sabiex tkun tidher il - parti taċ- ċentru tat- tapp tal- lastku.
Wipe the top of the vial with the alcohol swab provided, or use another antiseptic solution and allow to dry.
Imsaħ il- parti ta ’ fuq tal- kunjett b’ tajjara ta ’ l- alkoħol ipprovduta, jew uża xi solvent ieħor antisettiku u ħallih jinxef.
After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.
Wara dan it- tindif, tmissx b’ idejk it- tapp tal- lastku jew tħallih imiss ma xi ħaġa oħra.
Peel back the lid from the clear plastic vial adapter package.
Neħħi l- għatu mill- pakkett tal- plastik ċar tal- adapter tal- kunjett.
Do not remove the adapter from the package.
Tneħħix l- adapter mill- pakkett.
Place the vial on a flat surface.
Poġġi l- kunjett fuq wiċċ ċatt.
While holding the adapter package, place the vial adapter over the vial.
Waqt li żżomm f’ idejk il- pakkett tal- adapter, 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 fuq il- pakkett sakemm l- adapter jikklikkja fil- post fin - naħa ta ’ fuq tal- kunjett, bil- ponta ta ’ l- adapter li tippenetra jidħol fit- tapp tal- kunjett.
Lift the package away from the adapter and discard the package.
Għolli l- pakkett minn ma ’ l- adapter u armi l- pakkett.
Attach the plunger rod to the solvent syringe by inserting the rod into the opening in the syringe stopper and pushing and turning the rod firmly until it is securely seated in the stopper.
Waħħal il- planġer ta ’ wara tas- siringa tas- solvent billi ddaħħal il- planġer fil- ftuħ tat- tapp tas - siringa u timbotta u ddawwar il- planġer b’ mod sod sakemm tkun daħlet f’ postha b’ mod sod fit - tapp.
Break off the tamper-resistant plastic tip cap from the solvent syringe by snapping the perforation of the cap.
Ikser it- tapp tal- plastik (maħsub biex ma jkunx intmess) minn mas- siringa bis- solvent billi taqsam il- perforazzjoni tat- tapp.
This is done by bending the cap up and down until the perforation is broken.
Dan tagħmlu billi tilwi t- tapp ’ l isfel u ’ l fuq sakemm il- perforazzjoni tinkiser.
Do not touch the inside of the cap or the syringe tip.
Tmissx in- naħa ta ’ ġewwa tat- tapp jew il- ponta tas- siringa.
The cap may need to be replaced (if not administering reconstituted ReFacto AF immediately), so set it aside by placing it on its top.
It- tapp jista ’ jkollok bżonn terġa 'tpoġġih f' postu (jekk ma tkunx ser tagħti ReFacto AF rikostitwit immedjatament), u għalhekk poġġih fil- ġenb wiċċu ’ l 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 ddeffes il- ponta tas- siringa fil- ftuħ ta ’ l- adapter waqt li timbotta bis- saħħa u ddawwar is- siringa kif idur l- arloġġ sakemm issir il- konnessjoni.
Slowly depress the plunger rod to inject all the solvent into the ReFacto AF vial.
Agħfas bil- mod il- lasta tal- planġer biex tinjetta s- solvent kollu fil- kunjett ta ’ ReFacto AF.
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 must be inspected visually for particulate matter before administration.
Is- soluzzjoni finali trid tkun eżaminata viżwalment għal xi frak qabel tiġi mogħtija.
The solution will appear clear to slightly opalescent and colourless.
Is- soluzzjoni ser tidher minn ċara sa ftit opalexxenti u bla kulur.
Note:
77 Nota:
If you use more than one vial of ReFacto AF per infusion, each vial should be reconstituted as per the previous instructions.
Jekk tuża aktar minn kunjett wieħed ta ’ ReFacto AF għal kull infużjoni, kull kunjett għandu jiġi rikostitwit skond l- istruzzjonijiet mogħtija qabel.
The solvent syringe should be removed, leaving the vial adapter in place, and a single large luer lock syringe may be used to draw back the reconstituted contents of each of the individual vials.
Is- siringa tas- solvent għandha tkun imneħħiha waqt li tħalli l- adapter tal- kunjett f’ postu u siringa waħda separata b’ luer lock kbira tista ’ tintuża sabiex tiġbed lura l- kontenut rikostitwit ta ’ kull wieħed mill- kunjetti 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 tkun għadha magħfusa kollha ’ l isfel, aqleb il- kunjett wiċċu ’ l isfel.
Slowly draw back all the solution through the vial adapter into the syringe.
Iġbed lura bil- mod is- soluzzjoni kollha fis- 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 bil- mod tiġbed u ddawwar is- siringa kontra kif jimxi l - arloġġ.
Discard the vial with the adapter attached.
Armi l- kunjett bl- adapter imwaħħal miegħu.
If the solution is not to be used immediately, the syringe cap is to be carefully replaced.
Jekk is- soluzzjoni ma tkunx użata immedjatament, it- tapp tas- siringa għandu jitqiegħed f’ postu b’ attenzjoni.
Do not touch the syringe tip or the inside of the cap.
Tmissx il- ponta tas- siringa jew it- tapp minn ġewwa.
ReFacto AF must be used within 3 hours of reconstitution.
ReFacto AF irid jiġi użat fiż- żmien 3 sigħat minn wara r- rikostituzzjoni.
The reconstituted solution may be stored at room temperature prior to administration.
Is- soluzzjoni rikostitwita tista ’ tiġi maħżuna fit- temperatura tal- kamra qabel tingħata.
Administration (Intravenous Injection):
L- Għoti (Injezzjoni ġol- vina):
ReFacto AF should be administered using the infusion set provided in this kit and the pre-filled solvent syringe provided or a single sterile disposable plastic luer lock syringe.
ReFacto AF għandu jingħata bl- użu tas- sett ta ’ l- infużjoni pprovdut f’ dan il- kitt u s- siringa mimlija għal- lest tas- solvent li tkun ipprovduta, jew b’ siringa waħda sterili tal- plastik tat- tip luer lock li tintrema wara li tintuża.
Attach the syringe to the luer end of the infusion set tubing.
Waħħal is- siringa mat- tubing tat- tarf luer tas- sett ta ’ l- infużjoni.
Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab provided in the kit.
Applika turnikett u pprepara s- sit ta ’ l- injezzjoni billi timsaħ il- ġilda bir- reqqa bl- imsieħ mxarrba bl- alkoħol ipprovduta fil- kitt.
Insert the needle on the infusion set tubing into the vein as instructed by your doctor, and remove the tourniquet.
Daħħal il- labra fil- pajp tas- sett ta ’ l- infużjoni ġol- vina skond kif qallek it- tabib, u neħħi t - turnikett.
Remove any air in the infusion set tubing by drawing back on the syringe.
Neħħi kwalunkwe arja fil- pajp tas- sett ta ’ l- infużjoni billi tiġbed lura s- siringa.
The reconstituted product is to be injected intravenously over several minutes.
Il - prodott rikostitwit għandu jkun injettat ġol- vina fuq medda 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, the empty vial(s) and the used needles and syringes in an appropriate container for throwing away of medical waste as these materials may hurt others if not disposed of properly.
Jekk jogħġbok armi s- soluzzjoni kollha mhix użata, il- kunjett( i) vojt( a) u l- labar u s- siringi użati, f’ kontenitur għar- rimi ta ’ skart mediku, għax dawn il- materjali jistgħu jweġġgħu lill- oħrajn jekk ma jintremewx kif suppost.
If you take more ReFacto AF than you should
78 Jekk tieħu ReFacto AF aktar milli suppost
Check with your doctor or pharmacist.
Iċċekkja mat- tabib jew ma ’ l- ispiżjar tiegħek.
If you stop taking ReFacto AF
Jekk tieqaf tieħu ReFacto AF
Do not stop using ReFacto AF without consulting your doctor.
Tiqafx tuża ReFacto AF mingħajr ma titkellem mat- tabib tiegħek.
If you have any further questions regarding this product, ask your doctor or pharmacist.
Jekk ikollok mistoqsijiet addizzjonali dwar dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, ReFacto AF can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ReFacto AF jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Inhibitor development
Żvilupp ta ’ inibitur
Patients with haemophilia A may develop neutralising antibodies (inhibitors) to factor VIII.
Pazjenti b’ emofilija A jistgħu jiżviluppaw antikorpi li jinnewtralizzaw (inibituri) għall- fattur VIII.
If such inhibitors occur, a sign may be an increase in the amount of ReFacto AF typically required to treat a bleed and/or continued bleeding after a treatment.
Jekk dawn l- inibituri jseħħu, sinjal jista ’ jkun żieda fl- ammont ta ’ ReFacto AF tipikament meħtieġ biex jikkura emorraġiji u/ jew emorraġiji kontinwi wara xi kura.
Your doctor may want to monitor you for inhibitor development.
It- tabib tiegħek jista ’ jkun jixtieq li jimmonitorjak għall- iżvilupp ta ’ l- inibitur.
Development of inhibitors occurred in approximately 2% of patients receiving ReFacto AF in a research study.
L- iżvilupp ta ’ inibituri seħħ f’ madwar 2% tal- pazjenti li kienu qed jirċievu ReFacto AF fi studju ta ’ riċerka.
If you experience a significant increase in your usage of ReFacto AF in order to control a bleed, please contact your doctor immediately.
Jekk ikollok żieda sinifikanti fl- użu ta ’ ReFacto AF biex tikkontrolla l- ħruġ tad- demm, jekk jogħġbok ikkuntattja lit- tabib tiegħek immedjatament.
Side effects may occur with certain frequencies, which are defined as follows: • very common: affects more than 1 user in 10 • common: affects 1 to 10 users in 100 • uncommon: affects 1 to 10 users in 1,000 • rare: affects 1 to 10 users in 10,000
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej: • komuni ħafna, jaffettwaw iktar minn utent 1 minn kull 10 • komuni: jaffettwaw minn 1 sa 10 utenti minn kull 100 • mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 • rari: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 • rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10, 000 • mhux magħruf: ma tistax tittieħed stima mid- data disponibbli.
Very common side effects • Vomiting • Inhibitor development for patients who have never been previously treated with factor VIII products
Effetti sekondarji komuni ħafna • Rimettar • L- iżvilupp ta ’ inibitur għal pazjenti li qatt ma kienu kkurati bi prodotti ta ’ fattur VIII
Common side effects • Bleeding • Inhibitor development for patients who have been previously treated with factor VIII products • headache, nausea • joint pain, muscular pain • fatigue, fever • venous access catheter complications
Effetti sekondarji komuni • Ħruġ ta ’ demm • L- iżvilupp ta ’ inibitur għal pazjenti li kienu kkurati fil- passat bi prodotti ta ’ fattur VIII • uġigħ ta ’ ras, nawseja • uġigħ fil- ġogi, uġigħ fil- muskoli • għeja kbira, deni • kumplikazzjonijiet fl- aċċess venuż bil- kateter
• Severe allergic reaction, dizziness, light-headedness, hives, itching, rash • chest pain, shortness of breath, rapid heart beat • diarrhoea, loss of appetite, stomach pain • altered taste • chills, sweating, muscle weakness • sleepiness • coughing • injection site reactions (including burning and stinging at the infusion site), discomfort and swelling at the intravenous site • slight increase in heart enzymes • increased liver enzymes, increased bilirubin
Effetti sekondarji mhux komuni • Reazzjoni allerġika severa, sturdament, mejt, urtikarja, ħakk, raxx • uġigħ fis- sider, qtugħ ta ’ nifs, taħbit mgħaġġel tal- qalb • dijarea, telf ta ’ aptit, uġigħ fl- istonku • tibdil fit- togħma • tertir ta ’ bard, għaraq, dgħjufija fil- muskoli • ngħas • sogħla 79 • reazzjonijiet fis- sit tal- injezzjoni (li jinkludu ħruq u tingiż fis- sit tal- infużjoni), skonfort u nefħa fis- sit tal- għoti ġol- vina • żieda żgħira fl- enzimi tal- qalb • żieda fl- enzimi tal- fwied, żieda fil- bilirubina
The following adverse reactions have also been reported: numbness, blurred vision, acne, gastroenteritis, and pain.
Ir- reazzjonijiet avversi li ġejjin kienu rrappurtati wkoll: tingiż, vista mċajpra, akne, gastroenterite, u wġigħ.
Hypersensitivity/allergic reactions
Sensittività eċċessiva/ reazzjonijiet allerġiċi
If severe, sudden allergic reactions (anaphylactic) occur, the injection must be stopped immediately.
Jekk iseħħu reazzjonijiet allerġiċi severi għal għarrieda (anafilattiċi), l- injezzjoni trid titwaqqaf immedjatament.
You must contact your doctor immediately if you have any of the following early symptoms of allergic (hypersensitivity) reactions: • rash, hives, wheals, generalised itching • swelling of lips and tongue • difficulty in breathing, wheezing, tightness in the chest • general feeling of being unwell • dizziness and loss of consciousness
Trid tikkuntattja lit- tabib tiegħek immedjatament jekk ikollok kwalunkwe minn dawn is- sintomi bikrija ta ’ reazzjonijiet allerġiċi (sensittività eċċessiva): • raxx, urtikarja, wheals, u ħakk ġeneralizzat • nefħa fix- xufftejn u fl- ilsien • diffikultà biex tieħu n- nifs, tħarħir, għafis fis- sider • sensazzjoni ġenerali li ma tħossokx tajjeb • sturdament u tintilef minn sensik
Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.
Sintomi severi, li jinkludu diffikultà biex tieħu n- nifs u (kważi) iħossok ħażin, jeħtieġu kura ta ’ emerġenza fil- pront.
If you are concerned about any side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk qed tinkwieta dwar xi wieħed mill- effetti sekondarji, jew jekk tinnota xi effetti sekondarji minbarra dawk imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
If such inhibitors occur, a sign may be an increase in the amount of ReFacto AF typically required to treat a bleed and/or continued bleeding after a treatment.
Jekk dawn l- inibituri jseħħu, sinjal jista ’ jkun żieda fl- ammont ta ’ ReFacto AF tipikament meħtieġ biex jikkura ħruġ ta ’ demm u/ jew ħruġ ta ’ demm kontinwu wara l- kura.
In such cases, it is recommended that a specialised haemophilia centre be contacted.
F’ każijiet bħal dawn, hu rakkomandat li ċentru speċjalizzat tal- emofilja jiġi kkuntattjat.
HOW TO STORE REFACTO AF
KIF TAĦŻEN REFACTO AF
Do not use after the expiry date stated on the outer carton and vial label after EXP.
Tużax wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun ta ’ barra u fuq it- tikketta tal- kunjett wara JIS.
Store and transport refrigerated (2°C – 8°C).
Aħżen u ġorr fil- friġġ (2°C - 8°C).
Do not freeze, in order to prevent damage to the pre-filled solvent syringe.
Tagħmlux fil- friża, biex ma ssirx ħsara lis- siringa bis- solvent mimlija għal- lest.
For your convenience, the product can be removed from such storage for one single period of maximum 3 months at room temperature (up to 25°C).
Għall- konvenjenza tiegħek, il- prodott jista ’ jinħareġ mill- friġġ għall- perjodu ta ’ darba biss sa massimu ta ’ 3 xhur f’ temperatura tal- kamra (sa 25°C).
At the end of this room temperature storage period, the product must not be put back in the refrigerator, but must be used or discarded.
Fit- tmiem ta ’ dan il- perjodu li l- prodott ikun fit - temperatura tal- kamra, il- prodott m’ għandux jitpoġġa lura fil- friġġ, iżda għandu jintuża jew jintrema.
Record on the outer carton the date ReFacto AF is removed from the refrigerator and set at room temperature (up to 25oC).
Ikteb fuq il- kartuna ta ’ barra d- data li ReFacto AF jitneħħa mill- friġġ u jitqiegħed ft- temperatura tal - kamra (sa 25oC).
Use the reconstituted solution within 3 hours of reconstitution.
Uża s- soluzzjoni li tkun ġiet ippreparata fi żmien 3 sigħat wara r- rikostituzzjoni.
The solution will be clear to slightly opalescent and colourless.
Is- soluzzjoni ser tkun ċara sa ftit opalexxenti, u bla kulur.
Do not use ReFacto AF if you notice that it is cloudy or contains visible particles.
Tużax ReFacto AF jekk tinnota li hu mċajpar jew ikun fih frak viżibbli.
Medicines must not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What ReFacto AF contains
X’ fih ReFacto AF
- The active substance is moroctocog alfa (recombinant coagulation factor VIII).
- Is- sustanza attiva hi moroctocog alfa (fattur VIII tal- koagulazzjoni rikombinanti).
Each vial of
Kull kunjett
ReFacto AF contains nominally 250, 500, 1000, or 2000 IU of moroctocog alfa.
ta ’ ReFacto AF nominalment fih 250, 500, 1000, jew 2000 IU ta ’ moroctocog alfa.
- The other ingredients are sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80 and
- Is- sustanzi l- oħra huma sucrose, calcium chloride dihydrate, L- histidine, polysorbate 80 u
sodium chloride.
sodium chloride.
A solvent [sodium chloride 9 mg/ml (0.9%) solution for injection] is also supplied for reconstitution.
Solvent [soluzzjoni għall- injezzjoni ta ’ 9 mg/ ml (0. 9%) sodium chloride] hu fornut ukoll għar- rikostituzzjoni.
- After reconstitution with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution], each
- Wara rikostituzzjoni bis- solvent fornut [soluzzjon ta ’ 9 mg/ ml (0. 9%) sodium chloride], kull
vial contains 62.5, 125, 250, or 500 IU, respectively (based on the strength of moroctocog alfa, i.e., 250, 500, 1000, or 2000 IU), of moroctocog alfa per 1 ml of the prepared solution for injection.
250, 500, 1000, jew 2000 IU), ta ’ moroctocog alfa f’ kull 1 ml tas- soluzzjoni ppreparata għall- injezzjoni.
What ReFacto AF looks like and contents of the pack
Id- dehra ta ’ ReFacto AF u l- kontenuti tal- pakkett
ReFacto AF is provided as a powder for injection in a glass vial and a solvent is provided in a pre- filled syringe.
ReFacto AF hu pprovdut bħala trab għall- injezzjoni f’ kunjett tal- ħġieġ u solvent li hu pprovdut f’ siringa mimlija għal- lest.
The contents of the pack are:
Il- pakkett ikun fih:
- one vial of moroctocog alfa 250, 500, 1000, or 2000 IU powder
- kunjett wieħed ta ’ trab ta ’ moroctocog alfa 250, 500, 1000, jew 2000 IU
- one pre-filled syringe of solvent, 4 ml sterile sodium chloride 9 mg/ml (0.9%) solution for
- siringa mimlija għal- lest bis- solvent, 4 ml ta ’ soluzzjoni sterili ta ’ 9 mg/ ml (0. 9%) sodium
injection for reconstitution, with one plunger rod
chloride għall- injezzjoni għar- rikostituzzjoni, b’ lasta tal- planġer waħda
- one sterile vial adapter reconstitution device
- adapter sterili wieħed tal- kunjett tat- tagħmir għar- rikostituzzjoni
- one sterile infusion set
- sett sterili wieħed ta ’ l- infużjoni
- two alcohol swabs
- żewġ msiħ bl- alkoħol
- one plaster
- stikka waħda
- one gauze pad
- pad wieħed tal- garża
Manufacturers
Manifatturi
Carretera A-1 Km 23 Desvio Algete Km 1 28700 San Sebastian de los Reyes Madrid Spain
Carretera A- 1 Km 23 Desvio Algete Km 1 28700 San Sebastian de los Reyes Madrid Spanja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
81 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Suomi/Finland Wyeth Puh/Tel:+358 20 7414 870 Fax:+358 20 7414 879
82 Suomi/ Finland Ireland Wyeth Wyeth Pharmaceuticals Puh/ Tel: +358 20 7414 870 Tel: +353 1 449 3500 Fax: +358 20 7414 879 Fax: +353 1 449 3522
Detailed information on this medicine is available on European Medicines Agency (EMEA) website: http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
79 ANNEX IV
83 ANNESS IV
GROUNDS FOR ONE ADDITIONAL RENEWAL
RAĠUNIJIET GĦAL TIĠDID WIEĦED ADDIZZJONALI
80 GROUNDS FOR ONE ADDITIONAL RENEWAL
84 RAĠUNIJIET GĦAL TIĠDID WIEĦED ADDIZZJONALI
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of ReFacto AF remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Ibbażat fuq id- dejta li saret disponibbli minn meta ingħatat l- ewwel Awtorizzazzjoni għat - Tqegħid fis- Suq, is- CHMP jikkunsidra li l- bilanċ tal- benefiċċju- riskju ta ’ ReFacto AF għadu pożittiv, iżda jikkunsidra li l- profil tas- sigurtà tiegħu għandu jiġi mmonitorjat mill- qrib għar - raġunijiet li ġejjin:
• to ensure appropriate monitoring of the introduction of the new Refacto AF on the market • to ensure appropriate implementation of the pharmacovigilance system / risk management plan
• biex ikun żgurat monitoraġġ adattat tal- introduzzjoni tar- Refacto AF il- ġdid fis- suq • biex tkun żgurata implimentazzjoni adattata tas- sistema tal- farmakoviġilanza/ pjan dwar l - immaniġġjar tar- riskju
The CHMP decided that the MAH should continue to submit 6 monthly PSURs.
Is- CHMP iddeċieda li d- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jkompli jissottometti PSURs kull 6 xhur.
Therefore, based upon the safety profile of Refacto AF, which requires the submission of 6 monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Għalhekk, ibbażat fuq il- profil tas- sigurtà ta ’ Refacto AF, li jeħtieġ is- sottomissjoni ta ’ PSURs kull 6 xhur, is- CHMP ikkonkluda li d- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jissottometti applikazzjoni addizzjonali għat- tiġdid fi żmien 5 snin.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
L- Istati Membri għandhom jiżguraw li l- kundizzjonijiet jew restrizzjonijiet kollha fir - rigward ta ’ l- użu mingħajr periklu u effettiv tal- prodott mediċinali deskritti hawn taħt, ikunu implimentati.
The educational pack for Healthcare Professionals should include the educational materials to be provided by prescribers to patients before they receive RefactoAF.
Il- pakkett edukattiv għall- Professjonisti fil- Qasam tal- Kura tas- Saħħa għandu jinkludi l- materjal edukattiv li ser jiġi pprovdut minn dawk li jagħtu riċetta lil pazjenti qabel ma dawn tal- aħħar jirċievu RefactoAF.
The educational materials for Healthcare professionals, patients and haemophiliac patients associations should include the following key elements: • The main differences between ReFacto AF and ReFacto • Changes highlighted in the Summary of Product Characteristics and Patient Information Leaflet for ReFacto AF • The visual points of differentiation in packaging for ReFacto AF versus ReFacto • Specific instructions regarding the proper identification, dosing and monitoring of ReFacto AF. • That after switching to ReFacto AF, patients should remain on ReFacto AF and not switch back to ReFacto. • The potential risks for medication errors in using different assays or laboratory standard for patient monitoring Information that the chromogenic substrate assay is strongly recommended to be used by laboratories when monitoring patients receiving ReFacto AF and that typically one stage clotting assay results are 20-50% lower than the chromogenic substrate assay results • The existence of another moroctocog alfa containing product for use outside Europe with a different potency assigned using a one stage clotting essay and the need for patients to take an adequate supply of their ReFacto AF for anticipated treatment while traveling.
Informazzjoni li l- assaġġ tas- substrat kromoġeniku hu rakkomandat bil - qawwi li jintuża mil- laboratorji meta jsir monitoraġġ ta ’ pazjenti li jkunu qed jirċievu ReFacto AF, u li tipikament, ir- riżultati tal- assaġġ tat- tagħqid tad- demm ta ’ stadju wieħed huma 20- 50% iktar baxxi mir- riżultati tal- assaġġ tas- substrat kromoġeniku. • L- eżistenza ta ’ prodott ieħor li fih moroctocog alfa għall- użu barra mill- Ewropa, b’ qawwa differenti assenjata, bl- użu ta ’ assaġġ tat- tagħqid tad- demm ta ’ stadju wieħed, u l- ħtieġa li l- pazjenti jieħdu magħhom provvista adegwata ta ’ ReFacto AF għall- kura antiċipata meta jivvjaġġaw.
Advice for health care professionals on possible need to adjust dosages for patients normally treated outside Europe with Xyntha. • The importance to report suspected adverse reactions (including inhibitor occurrence) detailing the name and the batch number of the product used.
Pariri lill - professjonisti fil- qasam tal- kura tas- saħħa dwar il- possibbiltà tal- ħtieġa li taġġusta d- dożaġġi għal pazjenti normalment kkurati barra mill- Ewropa b’ Xyntha. • L- importanza li tirrapporta reazzjonijiet avversi ssuspettati (li jinkludu l- okkorrenza ta ’ inibitur) li jkun fihom dettalji dwar l- isem u n- numru tal- lott tal- prodott li ntuża.
The importance to report medication errors, and their causes and consequences. • Instructions on record keeping with recommendation to record, the name and batch number of the product received, using the peel-off labels provided on the vial. • Additional messages regarding the transition plan for replacement of ReFacto with ReFacto AF in the Member State(s)
L- importanza li tirrapporta żbalji tal- mediċina, u l- kawżi u l- konsegwenzi tagħhom. • Struzzjonijiet dwar kif għandhom jinżammu r- rekords bir- rakkomandazzjoni li jinżamm rekord tal- isem u n- numru tal- lott tal- prodott riċevut, billi tuża t- tikketti li jitqaxxru, ipprovduti fuq il- kunjett. • Messaġġi addizzjonali dwar il- pjan ta ’ transizzjoni għas- sostituzzjoni ta ’ ReFacto b’ ReFacto AF fl- Istat( i) Membru( i).
The educational programme for laboratories should inform about the following key elements: • The main differences between ReFacto AF and ReFacto • Specific instructions regarding the proper monitoring of ReFacto AF. • The potential risks for medication errors in using different assays or laboratory standard for patient monitoring • Strong recommendation to use the chromogenic substrate assay when monitoring patients.
Il- programm edukattiv għal- laboratorji għandu jkun fih informazzjoni dwar l- elementi importanti li ġejjin: • Id- differenzi ewlenin bejn ReFacto AF u ReFacto. • Struzzjonijiet speċifiċi dwar il- monitoraġġ kif suppost ta ’ ReFacto AF. • Ir- riskji potenzjali fir- rigward ta ’ żbalji tal- mediċina billi tuża assaġġi differenti jew standard tal - laboratorju għall- monitoraġġ tal- pazjent.
Information that typically one stage clotting assay results are 20-50% lower than the chromogenic substrate assay results. • The purpose of the laboratory standard.
2 • Rakkomandazzjoni qawwija biex tuża l- assaġġ tas- substrat kromoġeniku meta timmonitorja l - pazjenti.
The differences in the new laboratory standard for ReFacto AF as compared to the laboratory standard for ReFacto and instructions on when to change to using the ReFacto AF laboratory standard.
Informazzjoni li tipikament, ir- riżultati tal- assaġġ tat- tagħqid tad- demm ta ’ stadju wieħed huma 20- 50% iktar baxxi mir- riżultati tal- assaġġ tas- substrat kromoġeniku. • L- iskop tal- istandard tal- laboratorju.
2 • Additional messages regarding the transition plan for replacement of ReFacto with ReFacto AF in the Member State(s)
Id- differenzi fl- istandard il- ġdid tal- laboratorju għal ReFacto AF ipparagunati mal- istandard tal- laboratorju għal ReFacto u l- istruzzjonijiet dwar meta tibdel u taqleb għall- istandard tal- laboratorju ta ’ ReFacto AF. • Messaġġi addizzjonali dwar il- pjan ta ’ transizzjoni għas- sostituzzjoni ta ’ ReFacto b’ ReFacto AF fl- Istat( i) Membru( i).
The Marketing Authorisation Holder shall agree the educational material with the national competent authorities in all the Member States prior to the launch of the product.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jaqbel dwar il- materjal edukattiv mal- awtoritajiet kompetenti nazzjonali fl- Istati Membri kollha qabel ma l- prodott jitpoġġa fuq is- suq.
Route of administration
Mnejn Jingħata
Powder and solvent for solution for injection
Trab u solvent għas - soluzzjoni għall - injezzjoni
Powder: vial (glass); Solvent: pre- filled syringe
Trab: kunjett (ħġieġ); Solvent: siringa mimlija għal- lest
250 IU; Solvent:
250 IU; Solvent:
1 vial + 1 pre-filled syringe + 1 vial adapter + 1 sterile infusion set + 2 alcohol swabs + 1 plaster +1 gauze
1 kunjett + 1 siringa mimlija għal - lest + 1 adapter tal- kunjett + 1 sett sterili tal - infużjoni + 2 biċċiet li jnaddfu li jkun fihom l- alkoħol + 1 stikka +1 garża
500 IU; Solvent:
500 IU; Solvent:
1000 IU; Solvent:
1000 IU; Solvent:
2000 IU; Solvent:
2000 IU; Solvent:
This document is a summary of the European Public Assessment Report (EPAR).
Sommarju ta ’ l- EPAR għall- pubbliku Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR).
What is Refludan?
X’ inhu Refludan?
Refludan is a vial containing a powder to be dissolved to make up a solution for injection or infusion (drip into a vein).
Refludan huwa kunjett li fih trab li jrid jiġi maħlul biex jagħmel soluzzjoni għal injezzjoni jew għal infużjoni (dripp ġo vina).
It contains the active substance lepirudin.
Huwa fih is- sustanza attiva lepirudin.
What is Refludan used for?
Għalxiex jintuża Refludan?