qanastek/EMEA-V3 huggingface dataset:
In a study in which the potency of ReFacto AF, ReFacto and FVIII activity in patient plasma were measured using the chromogenic substrate assay, ReFacto AF was shown to be bioequivalent to ReFacto.
Fi studju li fih il- qawwa ta ’ ReFacto AF, ReFacto u l- attività ta ’ FVIII fil- plażma tal- pazjent tkejlu bl - użu ta ’ l- assaġġ tas- substrat kromoġeniku, intwera li ReFacto AF kien bijoekwivalenti għal ReFacto.
The ratios of geometric least-square means of ReFacto AF-to-ReFacto were 100.6%, 99.5% and 98.1% for K-value, AUCt and AUC∞ (area under the plasma concentration curve from time zero to infinity), respectively.
Il- proporzjonijiet tal- medji least- square ġeometriċi ta ’ ReFacto AF mal- medji ta ’ ReFacto kienu ta ’ 100. 6%, 99. 5% u 98. 1% għall- valur K, AUCt u AUC∞ (żona taħt il- kurva tal- konċentrazzjoni tal - plażma minn żero sal- infinità), rispettivament.
The corresponding 90% confidence intervals about the ratios of ReFacto AF to ReFacto geometric means were within the bioequivalence window of 80% to 125%, demonstrating bioequivalence of ReFacto AF to ReFacto.
L- intervalli tal- kunfidenza korrispondenti ta ’ 90% dwar il- proporzjonijiet ta ’ ReFacto AF mal- medji ġeometriċi ta ’ ReFacto kienu fil- bioequivalence window ta ’ 80% sa 125%, li juru bijoekwivalenza ta ’ ReFacto AF ma ’ ReFacto.
In a cross-over pharmacokinetic study, the pharmacokinetic parameters for ReFacto AF were determined at baseline and followed-up in 25 previously treated patients (≥ 12 years) after repeated administration of ReFacto AF for six months.
Fi studju farmakokinetiku cross- over, il- parametri farmakokinetiċi għal ReFacto AF kienu stabbiliti fil- linja bażi u kienu segwiti f’ 25 pazjent li kienu kkurati qabel (≥12- il sena) wara l- għoti ripetut ta ’ ReFacto AF għal sitt xhur.
The ratios of geometric least-square means of month 6-to-baseline pharmacokinetic were 107%, 100% and 104% for K-value, AUCt and AUC∞, respectively.
Il- proporzjonijiet tal- medji least- square ġeometriċi tas- 6 xahar mal- linja bażi tal- farmakokinetika kienu ta ’ 107%, 100% u 104% għall- valur K, AUCt u AUC∞, rispettivament.
The corresponding 90% confidence intervals about the ratios of month 6-to-baseline for the above pharmacokinetic parameters were within the equivalence window of 80% to 125%.
L- intervalli tal- kunfidenza korrispondenti ta ’ 90% dwar il- proporzjonijiet tas- 6 xahar mal- linja bażi għall- parametri farmakokinetiċi t’ hawn fuq kienu fl- equivalence window ta ’ 80% sa 125%.
This indicates no time-dependent changes in the pharmacokinetic properties of ReFacto AF.
Dan ma jindika l- ebda tibdil li jiddependi fuq il- ħin fil- proprjetajiet farmakokinetiċi ta ’ ReFacto AF.
In the same study, in which the drug potency of ReFacto AF and a full-length recombinant factor VIII (FLrFVIII) comparator, and the FVIII activity measured in patient plasma samples were all determined using the same one-stage clotting assay at a central laboratory, ReFacto AF was shown to be pharmacokinetically equivalent to FLrFVIII in 30 previously treated patients (≥ 12 years) using the standard bioequivalence approach.
Fl- istess studju, li fih il- qawwa ta ’ ReFacto AF u komparatur (FLrFVIII) ta ’ fattur rikombinanti VIII full- length, u l- attività FVIII imkejla f’ kampjuni tal- plażma tal- pazjenti kienu kollha stabbiliti bl- użu tal- istess assaġġ tat- tagħqid ta ’ demm bi stadju wieħed f’ laboratorju ċentrali, intwera li ReFacto AF kien farmakokinetikament ekwivalenti għal FLrFVIII fi 30 pazjent li kienu kkurati qabel (≥ 12- il sena) bl- użu tal- bijoekwivalenza standard.
In PUPs, pharmacokinetic parameters of ReFacto were evaluated using the chromogenic assay.
9 Fil- PUPs, il- parametri farmakokinetiċi ta ’ ReFacto kienu evalwati bl- użu ta ’ analiżi kromoġenika.
These patients (n=59; median age 10 ± 8.3 months) had a mean incremental recovery at Week 0 of 1.5 ± 0.6 IU/ dl per IU/ kg (range 0.2 to 2.8 IU/ dl per IU/ kg) which was lower than that obtained in PTPs treated with ReFacto at Week 0 with a mean K-value of 2.4 ± 0.4 IU/ dl per IU/ kg (range 1.1 to 3.8 IU/ dl per IU/ kg).
Dawn il- pazjenti (n=59; età medjana 10 ± 8. 3) kellhom medja ta ’ l- irkuprar inkrementali f’ Ġimgħa 0 ta ’ 1. 5 ± 0. 6 IU/ dl f’ kull IU/ kg (medda 0. 2 sa 2. 8 IU/ dl f’ kull IU/ kg) li kienet iktar baxxa minn dik miksuba fil- PTPs ikkurati b’ ReFacto f’ Ġimgħa 0 b’ medja ta ’ valur K ta ’ 2. 4 ± 0. 4 IU/ dl f’ kull IU/ kg (medda 1. 1 sa 3. 8 IU/ dl f’ kull IU/ kg).
In the PUPs, the mean incremental recovery was stable over time (5 visits during a 2-year period) and ranged from 1.5 to 1.8 IU/ dl per IU/ kg.
Fil- PUPs, il- medja ta ’ l- irkuprar inkrementali kienet stabbli matul iż- żmien (5 viżti fuq perjodu ta ’ sentejn) u varjat minn 1. 5 sa 1. 8 IU/ dl f’ kull IU/ kg.
Population pharmacokinetic modeling using data from 44 PUPs led to a mean estimated half-life of 8.0 ± 2.2 hours.
L - immudellar farmakokinetiku tal- popolazzjoni bl- użu ta 'dejta minn 44 PUPs wassal għal medja ta ’ stima ta ’ half- life ta ’ 8. 0 ± 2. 2 sigħat.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity.
Informazzjoni mhix klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, u l- effett tossiku fuq il- ġeni, ma turi l- ebda periklu speċjali għall- bnedmin.
No investigations on carcinogenic potential or toxicity to reproduction have been conducted.
Ma saru l- ebda investigazzjonijiet dwar il- potenzjal karċinoġeniku jew it- tossoċità għar- riproduzzjoni.
Powder Sucrose Calcium chloride dihydrate L-Histidine Polysorbate 80 Sodium chloride
Trab Sucrose Calcium chloride dihydrate L- Histidine Polysorbate 80 Sodium chloride
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, including other infusion solutions.
Fl- assenza ta ’ studji dwar il- kompatibilità, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra, inklużi soluzzjonijiet ta ’ infużjoni oħra.
Only the provided infusion set is to be used, because treatment failure can occur as a consequence of human-coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Għandu jintuża biss l- apparat ta ’ l- infużjoni pprovdut għax il- kura tista ’ tfalli minħabba li l- fattur VIII tal- koagulazzjoni tal- bniedem jiġi assorbit mal- wiċċ ta ’ l- intern ta ’ xi apparat ta ’ l- infużjoni.
Unopened powder vial
Kunjett bit- trab mhux miftuħ
After reconstitution
Wara r- rikostituzzjoni
Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25oC.
L- istabbiltà kimika u waqt l- użu kienet murija għal 3 sigħat f’ temperaturi sa 25oC.
The product does not contain a preservative, and the reconstituted product should be used immediately, or within 3 hours after reconstitution.
Il- prodott ma fih l- ebda preservattiv, u l- prodott rikostitwit għandu jintuża immedjatament, jew fi żmien 3 sigħat wara r- rikostituzzjoni.
Other in-use storage times and conditions are the responsibility of the user.
Iż- żmien u l- kundizzjonijiet oħrajn tal- ħażna waqt l- użu huma r - responsabbiltà tal- utent.
Store and transport refrigerated (2°C - 8°C).
Ħażna u transport fil- friġġ (2°C - 8°C).
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.
The product may be removed from refrigerated storage for one single period of maximum 3 months at room temperature (up to 25°C).
Il- prodott jista ’ jinħareġ mill- friġġ fejn ikun maħżun għall- perjodu ta ’ darba biss sa massimu ta ’ 3 xhur f’ temperatura tal- kamra (sa 25°C).
At the end of this period of room temperature storage, the product must not be returned to refrigerated storage, but is to be used or discarded.
Fit- tmiem ta ’ dan il- perjodu li fih l- prodott ikun maħżun fit- temperatura tal- kamra, il- prodott m’ għandux jerġa ’ jiddaħħal fil- friġġ, iżda għandu jintuża jew jintrema.
250 IU powder in a 10 ml vial (type 1 glass) with a stopper (butyl) and a flip-off seal (aluminum) and 4 ml of solvent in a pre-filled syringe (type 1 glass) with a plunger stopper (butyl), a tip-cap (butyl) and a sterile vial adapter reconstitution device, a sterile infusion set, alcohol swabs, a plaster and a gauze pad.
250 IU trab f’ kunjett ta ’ 10 ml (ħġieġ ta ’ tip 1) b’ tapp (butyl) u siġill li tiftħu b’ daqqa ta ’ saba ’ (aluminju) u 4 ml ta ’ solvent f’ siringa mimlija għal- lest (ħġieġ ta ’ tip 1) bi planġer- tapp (butyl), għatu tat- tarf (butyl) u adapter sterili tal- kunjett tat- tagħmir tar- rikostituzzjoni, sett sterili ta ’ l- infużjoni, biċċiet bl- alkoħol, stikka u pad tal- garża.
The vial of lyophilised product powder for injection must be reconstituted with the supplied solvent [sodium chloride 9 mg/ ml (0.9%) solution] from the pre-filled syringe using the sterile vial adapter reconstitution device.
Il- kunjett bit- trab lajofilizzat tal- prodott għall- injezzjoni jrid jiġi rikostitwit bis- solvent fornut [soluzzjoni ta ’ 9 mg/ ml (0. 9%) sodium chloride] mis- siringa mimlija minn qabel bl- użu tat- tagħmir tar- rikostituzzjoni tal- adapter sterili tal- kunjett.
The vial should be gently rotated until all of the powder is dissolved.
Il- kunjett għandu jiddawwar bil- mod sakemm it- trab jinħall kollu.
The product, when reconstituted, contains polysorbate-80, which is known to increase the rate of di- (2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Meta rikostitwit, il- prodott ikun fih polysorbate- 80, li hu magħruf li jżid ir- rata ta ’ l- estrazzjoni ta ’ di - (2- ethylhexyl) phthalate (DEHP) minn polyvinyl chloride (PVC).
This is to be considered during the preparation and administration of the product, including storage time elapsed in a PVC container following reconstitution.
Dan il- fatt għandu jiġi kkunsidrat waqt il- preparazzjoni u l- għoti tal- prodott, li jinkludi ż- żmien kemm idum maħżun f’ kontenitur tal - PVC wara r- rikostituzzjoni.
It is important that the recommendations in section 6.3 be followed closely.
Huwa importanti li r- rakkomandazzjonijiet f’ sezzjoni 6. 3 ikunu segwiti mill- qrib.
After reconstitution, the solution is drawn back into the syringe.
Wara li tkun rikostitwita, is- soluzzjoni għandha tinġibed lura fis- siringa.
The solution will be clear or slightly opalescent and colourless.
Is- soluzzjoni tkun ċara jew xi ftit opalexxenti u bla ebda kulur.
The solution is to be discarded if visible particulate matter or discolouration is observed.
Is- soluzzjoni għandha titwarrab jekk jidher xi frak jew ma tkunx ċara.
Any unused product or waste material is to be disposed of in accordance with local requirements.
Xi prodott li mhux użat jew materjal ieħor għar- rimi għandu jintrema skond ir- regoli tal- lokalità.
13 April 1999 Date of last renewal:
13 ta ’ April, 1999
15 April 2009
15 ta ’ April, 2009
ReFacto AF 500 IU powder and solvent for solution for injection.
ReFacto AF 500 IU trab u solvent għas- soluzzjoni għall- injezzjoni.
Each vial contains nominally 500 IU* moroctocog alfa**.
Kull kunjett nominalment 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 fih madwar 125 IU ta ’ moroctocog alfa.
B-domain deleted) and similar post- translational modifications to those of the plasma-derived molecule.
B - domain mħassar), u modifikazzjoniet ta ’ wara l- bidla, simili għal molekula derivata mill- plażma.
The manufacturing process for ReFacto has been modified to eliminate exogenous human- or animal- derived protein in the cell culture process, purification, or final formulation; and at the same time the invented name has been changed to ReFacto AF.
Il- proċess tal- manifattura għal ReFacto kien modifikat biex tiġi eliminata kwalunkwe proteina esoġenika umana jew li hi derivata mill- annimali fil- proċess tal- koltura taċ- ċelluli, purifikazzjoni, jew il- formulazzjoni finali; u fl- istess ħin l- isem inventat inbidel għal ReFacto AF.
12 The labelled potency of ReFacto AF is based on the European Pharmacopoeial chromogenic substrate assay, in which the manufacturing potency standard has been calibrated to the WHO International Standard using the chromogenic substrate assay.
13 Il- qawwa tikkettata ta ’ ReFacto AF hi bbażata fuq l- assaġġ tas- substrat kromoġeniku tal - Pharmacopoeia Ewropea, li fih il- qawwa standard tal- manifattura kien ikkalibrat mal- Istandard Internazzjonali tal- WHO billi ntuża l- assaġġ tas- substrat kromoġeniku.
13 Degree of haemorrhage/ Type of surgical procedure
Grad ta ’ telf ta ’ demm /
Early haemarthrosis, muscle bleeding or oral bleeding
14 Emartrosi bikrija, muskolu jnixxi d- demm jew demm ħiereġ mill - ħalq.
More extensive haemarthrosis, muscle bleeding or haematoma
Emartrosi aktar estensiva, muskolu jnixxi d- demm jew tumur tad - demm.
Patients using factor VIII replacement therapy are to be monitored for the development of factor VIII inhibitors.
Il- pazjenti li jużaw it- terapija tas- sostituzzjoni ta ’ fattur VIII għandhom ikunu taħt osservazzjoni għall - iżvilupp ta ’ inibituri ta ’ fattur VIII.
Paediatric patients Safety and efficacy studies with ReFacto have been performed both in previously treated children and adolescents (n=31, ages 8-18 years) and in previously untreated neonates, infants and children (n=101, ages < 1-52 months).
Pazjenti pedjatriċi Studji dwar is- sigurtà u effikaċja b’ ReFacto twettqu kemm fi tfal u adolexxenti li kienu kkurati qabel (n=31, età 8- 18- il sena), kif ukoll fi trabi tat- twelid, trabi u tfal li ma kinux ikkurati qabel (n=101, età < 1- 52 xahar).
14 The need for an increased dose relative to that used for adults and older children should be anticipated when treating younger children with ReFacto AF.
15 Il- ħtieġa għal żieda fid- doża meta mqabbla ma ’ dik użata għall- adulti u tfal li għandhom iktar żmien, għandha tiġi antiċipata meta tikkura tfal iżgħar b’ ReFacto AF.
In a study of ReFacto in children less than 6 years of age, pharmacokinetic analysis revealed half-life and recovery less than that observed in older children and adults (see section 5.2).
Fi studju ta ’ ReFacto fit- tfal ta ’ inqas minn 6 snin, l- analiżi farmakokinetika żvelat half- life u rkuprar li kien inqas minn dak osservat fit- tfal li kellhom iktar żmien u fl- adulti (ara sezzjoni 5. 2).
Patients treated with recombinant coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests (see also section 4.8).
Pazjenti kkurati bil- fattur VIII tal- koagulazzjoni rikombinanti għandhom ikunu mmonitorjati bl- attenzjoni għall- iżvilupp ta ’ inibituri permezz ta ’ osservazzjonijiet kliniċi adegwati u testijiet fil - laboratorji (ara wkoll sezzjoni 4. 8).
Reports of lack of effect, mainly in prophylaxis patients, have been received in the clinical trials and in the post-marketing setting for ReFacto.
16 Rapporti ta ’ nuqqas ta ’ effett, primarjament f’ pazjenti tal- profilassi, kienu riċevuti fil- provi kliniċi u fl - isfond ta ’ wara t- tqegħid fis- suq ta ’ ReFacto.
The reported lack of effect with ReFacto has been described as bleeding into target joints, bleeding into new joints or a subjective feeling by the patient of new onset
In- nuqqas ta ’ effett irrappurtat b’ ReFacto kien deskritt bħala ħruġ ta ’ demm ġol- ġogi fil- mira, ħruġ ta ’ demm ġo ġogi ġodda jew sensazzjoni suġġettiva mill - pazjent ta ’ episodju ġdid ta ’ ħruġ ta ’ demm.
When prescribing ReFacto AF it is important to individually titrate and monitor each patient’ s factor level in order to ensure an adequate therapeutic response.
Meta tingħata riċetta għal ReFacto AF hu importanti li tagħmel titrazzjoni individwali u jsir monitoraġġ tal- livell tal- fattur ta ’ kull pazjent biex jiġi żgurat rispons terapewtiku adegwat.
There are no clinical data on previously untreated patients (PUPs) with ReFacto AF.
17 M’ hemm l- ebda dejta klinika dwar pazjenti li ma kinux ikkurati qabel (PUPs) b’ ReFacto AF.
IT had an efficacy of 73% for patients with high titres and 90% for those
L- IT kellha effikaċja ta ’ 73% għal pazjenti b’ tajters għoljin u 90% għal dawk b’ tajters baxxi.
Blood and lymphatic disorders Metabolism and nutrition disorders
Disturbi tad- demm u tas- sistema limfatika
Factor VIII inhibitors - PUPs
Inibituri ta ’ Fattur VIII - PUPs
Factor VIII inhibitors - PTPs
Inibituri ta ’ Fattur VIII - PTPs
Neuropathy, dizziness, somnolence, dysgeusia Angina pectoris, tachycardia, palpitations
Anġina pectoris, takikardija, palpitazzjonijiet Pressjoni baxxa, tromboflebite,
Haemorrhage/ haematoma
Emorraġija / Ematoma
Hypotension, thrombophlebitis, vasodilatation, flushing
vażodilatazzjoni, fwawar
Gastrointestinal disorders Skin and subcutaneous tissue disorders
Disturbi gastro - intestinali
Abdominal pain, diarrhoea Urticaria, pruritis, rash, hyperhidrosis
Urtikarja, ħakk, raxx, iperidrosi
Chills/ feeling cold, injection site inflammation, injection site reaction, injection site pain
Tertir ta ’ bard/ tħoss il- bard, infjammazzjoni fis- sit tal - injezzjoni, reazzjoni fis- sit tal - injezzjoni, uġigħ fis- sit tal - injezzjoni
Investigations
(≥1/ 100 sa < 1/ 10)
Aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, blood creatine phosphokinase increased
Żieda f’ aspartate aminotransferase, żieda f’ alanine aminotransferase, żieda fil- bilirubina fid- demm, żieda fil- creatine phosphokinase fid- demm
17 Safety of ReFacto AF was evaluated in previously treated children and adolescents (n=18, age 12-16 in a study and n=49, age 7-16 in a supporting study).
Is- sigurtà ta ’ ReFacto AF kienet evalwata fi tfal u adolexxenti li kienu kkurati qabel (n=18, età 12- 16 fi studju, u n=49, età 7- 16 fi studju ta ’ appoġġ).
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently for ReFacto, and may in some cases progress to severe anaphylaxis including shock (see section 4.4).
Sensittività eċċessiva u reazzjonijiet allerġiċi (li jistgħu jinkludu anġjodema, ħruq u tingiż fil- post ta ’ l- infużjoni, reżħat, sħanat żejda, urtikarja ġenerali, uġigħ ta ’ ras, ħorriqija, pressjoni baxxa, telqa, nawsja, nuqqas ta ’ sabar, takikardija, għafis fis- sider, tingiż, rimettar, tisfir fis- sider) dehru mhux ta ’ spiss għal ReFacto u jistgħu f’ xi każijiet jaggravaw għal anafilassi severa inkluż xokk (ara sezzjoni 4. 4).
Trace amounts of hamster protein may be present ReFacto AF.
Traċċi tal- proteini tal- ħamsters jistgħu jkunu preżenti f’ ReFacto AF.
Very rarely development of antibodies to hamster protein has been observed, but there were no clinical sequelae.
L- iżvilupp ta ’ antikorpi għall - proteini tal- ħamsters kien osservat b’ mod rari ħafna, iżda ma kien hemm l- ebda konsegwenzi kliniċi.
It is a glycoprotein with an approximate molecular mass of 170,000 Da consisting of 1438 amino acids.
Hu glikoproteina b’ massa molekulari ta ’ bejn wieħed u ieħor ta ’ 170, 000 Da magħmula 19 minn 1438 aċidi amminiċi.
By replacement therapy, the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Bit - terapija tas- sostituzzjoni, il- livelli tal- fattur VIII fil- plażma jiżdiedu, u b’ hekk dan jikkoreġi temporanjament id- defiċjenza tal- fattur u jikkoreġi t- tendenzi tat- tnixxija tad- demm.
18 Pharmacokinetic parameter estimates for ReFacto in previously treated patients with haemophilia A PK parameter
Stimi tal- parametri farmakokinetiċi għal ReFacto f’ pazjenti li kienu kkurati qabel u li għandhom l - emofilja A.
In a study in which the potency of ReFacto AF, ReFacto and FVIII activity in patient plasma were measured using the chromogenic substrate assay, ReFacto AF was shown to be bioequivalent to ReFacto.
20 Fi studju li fih il- qawwa ta ’ ReFacto AF, ReFacto u l- attività ta ’ FVIII fil- plażma tal- pazjent tkejlu bl - użu ta ’ l- assaġġ tas- substrat kromoġeniku, intwera li ReFacto AF kien bijoekwivalenti għal ReFacto.
The ratios of geometric least-square means of ReFacto AF-to-ReFacto were 100.6%, 99.5% and 98.1% for K-value, AUCt and AUC∞ (area under the plasma concentration curve from time zero to infinity), respectively.
Il- proporzjonijiet tal- medji least- square ġeometriċi ta ’ ReFacto AF mal- medji ta ’ ReFacto kienu ta ’ 100. 6%, 99. 5% u 98. 1% għall- valur K, AUCt u AUC∞, (żona taħt il- kurva tal- konċentrazzjoni tal - plażma minn żero sal- infinità), rispettivament.
In PUPs, pharmacokinetic parameters of ReFacto were evaluated using the chromogenic assay.
Fil- PUPs, il- parametri farmakokinetiċi ta ’ ReFacto kienu evalwati bl- użu ta ’ analiżi kromoġenika.
6.2 Incompatibilities
21 6. 2 Inkompatibilitajiet
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products, including other infusion solutions.
Fl- assenza ta ’ studji dwar il- kompatibilità, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra, inklużi soluzzjonijiet ta ’ infużjoni oħra.
Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25oC.
L- istabbiltà kimika u waqt l- użu kienet murija għal 3 sigħat f’ temperaturi sa 25°C.
500 IU powder in a 10 ml vial (type 1 glass) with a stopper (butyl) and a flip-off seal (aluminum) and 4 ml of solvent in a pre-filled syringe (type 1 glass) with a plunger stopper (butyl), a tip-cap (butyl) and a sterile vial adapter reconstitution device, a sterile infusion set, alcohol swabs, a plaster and a gauze pad.
500 IU trab f’ kunjett ta ’ 10 ml (ħġieġ ta ’ tip 1) b’ tapp (butyl) u siġill li tiftħu b’ daqqa ta ’ saba ’ (aluminju) u 4 ml ta ’ solvent f’ siringa mimlija għal- lest (ħġieġ ta ’ tip 1) bi planġer- tapp (butyl), għatu tat- tarf (butyl) u adapter sterili tal- kunjett tat- tagħmir tar- rikostituzzjoni, sett sterili ta ’ l- infużjoni, biċċiet bl- alkoħol, stikka u pad tal- garża.
20 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
After reconstitution, the solution is drawn back into the syringe.
22 Wara li tkun rikostitwita, is- soluzzjoni għandha tinġibed lura fis- siringa.
13 April 1999 Date of last renewal:
13 ta ’ April, 1999 Data ta ’ l- aħħar tiġdid:
ReFacto AF 1000 IU powder and solvent for solution for injection.
ReFacto AF 1000 IU trab u solvent għas- soluzzjoni għall- injezzjoni.
Each vial contains nominally 1000 IU* moroctocog alfa**.
Kull kunjett nominalment 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 fih madwar 250 IU ta ’ moroctocog alfa.
22 The labelled potency of ReFacto AF is based on the European Pharmacopoeial chromogenic substrate assay, in which the manufacturing potency standard has been calibrated to the WHO International Standard using the chromogenic substrate assay.
24 Il- qawwa tikkettata ta ’ ReFacto AF hi bbażata fuq l- assaġġ tas- substrat kromoġeniku tal - Pharmacopoeia Ewropea, li fih il- qawwa standard tal- manifattura kien ikkalibrat mal- Istandard Internazzjonali tal- WHO billi ntuża l- assaġġ tas- substrat kromoġeniku.
The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
L- ammont li għandu jiġi mogħti u l- frekwenza ta ’ l- għoti ta ’ ReFacto għandhom ikunu bbażati ma ’ l - effiċjenza klinika tal- każ individwali.
23 Degree of haemorrhage/ Type of surgical procedure
Grad ta ’ telf ta ’ demm / Tip ta ’ proċedura kirurġika Telf ta ’ demm
Factor VIII level required (% or IU/ dl)
Il- livell meħtieġ ta ’ Fattur VIII (% jew IU/ dl)
Frequency of doses (hours)/ Duration of therapy (days)
Il- frekwenza tad- dożi (sigħat) / Id - dewmien tat- terapija (ġranet)
Early haemarthrosis, muscle bleeding or oral bleeding
25 Emartrosi bikrija, muskolu jnixxi d - demm jew demm ħiereġ mill- ħalq.
Patients using factor VIII replacement therapy are to be monitored for the development of factor VIII inhibitors.
Il- pazjenti li jużaw it- terapija tas- sostituzzjoni ta ’ fattur VIII għandhom ikunu taħt osservazzjoni għall- iżvilupp ta ’ inibituri ta ’ fattur VIII.
Data from clinical trials indicated that if inhibitors are present at levels less than 10 Bethesda Units (BUs), administration of additional antihaemophilic factor may neutralise the inhibitors.
Id- dejta minn provi kliniċi indikat li jekk l- inibituri jinsabu f’ livelli ta ’ inqas minn 10 Unitajiet Bethesda (BU), l - għoti ta ’ fattur addizzjonali antiemofiliku jista ’ jinnewtralizza l- inibituri.
Paediatric patients Safety and efficacy studies with ReFacto have been performed both in previously treated children and adolescents (n=31, ages 8-18 years) and in previously untreated neonates, infants and children (n=101, ages < 1-52 months).
Studji dwar is- sigurtà u effikaċja b’ ReFacto twettqu kemm fi tfal u adolexxenti li kienu kkurati qabel (n=31, età 8- 18- il sena), kif ukoll fi trabi tat- twelid, trabi u tfal li ma kinux ikkurati qabel (n=101, età < 1- 52 xahar).
24 The need for an increased dose relative to that used for adults and older children should be anticipated when treating younger children with ReFacto AF.
26 Il- ħtieġa għal żieda fid- doża meta mqabbla ma ’ dik użata għall- adulti u tfal li għandhom iktar żmien, għandha tiġi antiċipata meta tikkura tfal iżgħar b’ ReFacto AF.
Reports of lack of effect, mainly in prophylaxis patients, have been received in the clinical trials and in the post-marketing setting for ReFacto.
27 Rapporti ta ’ nuqqas ta ’ effett, primarjament f’ pazjenti tal- profilassi, kienu riċevuti fil- provi kliniċi u fl - isfond ta ’ wara t- tqegħid fis- suq ta ’ ReFacto.
As with all coagulation factor VIII products, patients are to be monitored for the development of inhibitors that are to be titrated in Bethesda Units (BUs) using the Nijmegen modification of the Bethesda assay. If such inhibitors occur, the condition may manifest itself as an insufficient clinical response.
Jekk jiżviluppaw dawn l - inibituri, il- kundizzjoni tista ’ tidher bħala rispons kliniku insuffiċjenti.
In a clinical study with ReFacto AF in previously treated patients (PTPs), the incidence of factor VIII inhibitors was the primary safety endpoint.
Fi studju kliniku b’ ReFacto AF, f’ pazjenti li kienu kkurati qabel (PTPs), l- inċidenza ta ’ inibituri ta ’ fattur VIII kienet il- punt aħħari tas- sigurtà primarja.
In a clinical study with ReFacto PTPs, 1 inhibitor was observed in 113 patients.
Fi studju kliniku b’ ReFacto f’ PTPs, inibitur 1 kien osservat f’ 113- il pazjent.
There are no clinical data on previously untreated patients (PUPs) with ReFacto AF.
28 M’ hemm l- ebda dejta klinika dwar pazjenti li ma kinux ikkurati qabel (PUPs) b’ ReFacto AF.
Of the 16 patients with low titres, IT
Mis- 16- il pazjent b’ tajters għoljin, 15 irċivew kura ta ’ tolleranza immuni (IT).
26 treatment was started in 10.
Mis- 16- il pazjent b’ tajters baxxi, il- kura IT inbdiet f’ 10 minnhom.
Frequency of Occurrence per Patient with ReFacto or ReFacto AF System organ class
Frekwenza ta ’ Okkorrenza għal kull Pazjent b’ ReFacto jew ReFacto AF
27 Safety of ReFacto AF was evaluated in previously treated children and adolescents (n=18, age 12-16 in a study and n=49, age 7-16 in a supporting study).
Is- sigurtà ta ’ ReFacto AF kienet evalwata fi tfal u adolexxenti li kienu kkurati qabel (n=18, età 12- 16 fi studju, u n=49, età 7- 16 fi studju ta ’ appoġġ).
Although a limited number of children have been studied, there is a tendency for higher frequencies of adverse events in children aged 7-16 as compared to adults. A clinical trial evaluating use of moroctocog alfa (AF-CC) in children less than 6 years of age is on going.
Prova klinika li evalwat l- użu ta ’ moroctocog alfa (AF- CC) fi tfal ta ’ inqas minn 6 snin għadha għaddejja.
ReFacto AF contains B-domain deleted recombinant coagulation factor VIII, (moroctocog alfa).
ReFacto AF fih il- fattur tal- koagulazzjoni rikombinanti VIII (moroctocog alfa) bid- dominju B imħassar.
It is a glycoprotein with an approximate molecular mass of 170,000 Da consisting of 1438 amino acids.
Hu glikoproteina b’ massa molekulari ta ’ bejn wieħed u ieħor ta ’ 170, 000 Da magħmula 30 minn 1438 aċidi amminiċi.
By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Bit- terapija tas- sostituzzjoni, il- livelli tal- fattur VIII fil- plażma jiżdiedu, u b’ hekk dan jikkoreġi temporanjament id- defiċjenza tal- fattur u jikkoreġi t- tendenzi tat- tnixxija tad- demm.
28 Pharmacokinetic parameter estimates for ReFacto in previously treated patients with haemophilia A
Stimi tal- parametri farmakokinetiċi għal ReFacto f’ pazjenti li kienu kkurati qabel u li għandhom l - emofilja A.
PK parameter
Parametru tal- PK
In a study in which the potency of ReFacto AF, ReFacto and FVIII activity in patient plasma were measured using the chromogenic substrate assay, ReFacto AF was shown to be bioequivalent to ReFacto.
31 Fi studju li fih il- qawwa ta ’ ReFacto AF, ReFacto u l- attività ta ’ FVIII fil- plażma tal- pazjent tkejlu bl - użu ta ’ l- assaġġ tas- substrat kromoġeniku, intwera li ReFacto AF kien bijoekwivalenti għal ReFacto.
The ratios of geometric least-square means of ReFacto AF-to-ReFacto were 100.6%, 99.5% and 98.1% for K-value, AUCt and AUC∞ (area under the plasma concentration curve from time zero infinity), respectively.
Il- proporzjonijiet tal- medji least- square ġeometriċi ta ’ ReFacto AF mal- medji ta ’ ReFacto kienu ta ’ 100. 6%, 99. 5% u 98. 1% għall- valur K, AUCt u AUC∞ (żona taħt il- kurva tal- konċentrazzjoni tal - plażma minn żero sal- infinità), rispettivament.
The ratios of geometric least-square means of month 6- to-baseline pharmacokinetic were 107%, 100% and 104% for K-value, AUCt and AUC∞, respectively.
Il- proporzjonijiet tal- medji least- square ġeometriċi tas- 6 xahar mal- linja bażi tal- farmakokinetika kienu ta ’ 107%, 100% u 104% għall- valur K, AUCt u AUC∞, rispettivament.
30 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
1000 IU powder in a 10 ml vial (type 1 glass) with a stopper (butyl) and a flip-off seal (aluminum) and 4 ml of solvent in a pre-filled syringe (type 1 glass) with a plunger stopper (butyl), a tip-cap (butyl) and a sterile vial adapter reconstitution device, a sterile infusion set, alcohol swabs, a plaster and a gauze pad.
1000 IU trab f’ kunjett ta ’ 10 ml (ħġieġ ta ’ tip 1) b’ tapp (butyl) u siġill li tiftħu b’ daqqa ta ’ saba ’ (aluminju) u 4 ml ta ’ solvent f’ siringa mimlija għal- lest (ħġieġ ta ’ tip 1) bi planġer- tapp (butyl), għatu tat- tarf (butyl) u adapter sterili tal- kunjett tat- tagħmir tar- rikostituzzjoni, sett sterili ta ’ l- infużjoni, biċċiet bl- alkoħol, stikka u pad tal- garża.
After reconstitution, the solution is drawn back into the syringe.
33 Wara li tkun rikostitwita, is- soluzzjoni għandha tinġibed lura fis- siringa.
ReFacto AF 2000 IU powder and solvent for solution for injection.
ReFacto AF 2000 IU trab u solvent għas- soluzzjoni għall- injezzjoni.
Each vial contains nominally 2000 IU* moroctocog alfa**.
Kull kunjett nominalment 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 fih madwar 500 IU ta ’ moroctocog alfa.
32 The labelled potency of ReFacto AF is based on the European Pharmacopoeial chromogenic substrate assay, in which the manufacturing potency standard has been calibrated to the WHO International Standard using the chromogenic substrate assay.
35 Il- qawwa tikkettata ta ’ ReFacto AF hi bbażata fuq l- assaġġ tas- substrat kromoġeniku tal - Pharmacopoeia Ewropea, li fih il- qawwa standard tal- manifattura kien ikkalibrat mal- Istandard Internazzjonali tal- WHO billi ntuża l- assaġġ tas- substrat kromoġeniku.
33 Degree of haemorrhage/ Type of surgical procedure
Grad ta ’ telf ta ’ demm /
Early haemarthrosis, muscle bleeding or oral bleeding
36 Emartrosi bikrija, muskolu jnixxi d- demm jew demm ħiereġ mill - ħalq.
34 The need for an increased dose relative to that used for adults and older children should be anticipated when treating younger children with ReFacto AF.
37 Il- ħtieġa għal żieda fid- doża meta mqabbla ma ’ dik użata għall- adulti u tfal li għandhom iktar żmien, għandha tiġi antiċipata meta tikkura tfal iżgħar b’ ReFacto AF.
Reports of lack of effect, mainly in prophylaxis patients, have been received in the clinical trials and in the post-marketing setting for ReFacto.
38 Rapporti ta ’ nuqqas ta ’ effett, primarjament f’ pazjenti tal- profilassi, kienu riċevuti fil- provi kliniċi u fl - isfond ta ’ wara t- tqegħid fis- suq ta ’ ReFacto.
35 In the interest of patient safety, it is recommended that every time ReFacto AF is administered, the name on the carton and batch number of the product are recorded.
Fl- interess tas- sigurtà tal- pazjent, hu rakkomandat li kull darba li ReFacto AF jingħata, l- isem fuq il - kartuna u n- numru tal- lott tal- prodott jiġu rrekordjati.
There are no clinical data on previously untreated patients (PUPs) with ReFacto AF.
39 M’ hemm l- ebda dejta klinika dwar pazjenti li ma kinux ikkurati qabel (PUPs) b’ ReFacto AF.
36 Adverse reactions based on experience from clinical trials with ReFacto or ReFacto AF are presented in the table below by system organ class.
Reazzjonijiet avversi bbażati fuq esperjenza minn provi kliniċi b’ ReFacto jew ReFacto AF huma ppreżentati fit- tabella hawn taħt skond il- klassi ta ’ l- organu tas- sistema.
Safety of ReFacto AF was evaluated in previously treated children and adolescents (n=18, age 12-16 in a study and n=49, age 7-16 in a supporting study).
Is- sigurtà ta ’ ReFacto AF kienet evalwata fi tfal u adolexxenti li kienu kkurati qabel (n=18, età 12- 16 fi studju, u n=49, età 7- 16 fi studju ta ’ appoġġ).
Although a limited number of children have been studied, there is a tendency for higher frequencies of adverse events in children aged 7-16 as compared
Għalkemm numru limitat ta ’ tfal kienu studjati, hemm tendenza għal frekwenzi ogħla ta ’ avvenimenti avversi fit- tfal ta ’ bejn 7 u 16- il sena meta mqabbel mal- adulti.
It is a glycoprotein with an approximate molecular mass of 170,000 Da consisting of 1438 amino acids.
Hu glikoproteina b’ massa molekulari ta ’ bejn wieħed u ieħor ta ’ 170, 000 Da magħmula 41 minn 1438 aċidi amminiċi.
38 Pharmacokinetic parameter estimates for ReFacto in previously treated patients with haemophilia A
Stimi tal- parametri farmakokinetiċi għal ReFacto f’ pazjenti li kienu kkurati qabel u li għandhom l - emofilja A.
AUCt (IU· h/ ml)
AUCt (IU siegħa/ ml) t1/ 2 (sigħat)
t1/ 2 (h) CL (ml/ h· kg) MRT (h) K-value
CL (ml/ siegħa kg) MRT (siegħa) Valur K
In a study in which the potency of ReFacto AF, ReFacto and FVIII activity in patient plasma were measured using the chromogenic substrate assay, ReFacto AF was shown to be bioequivalent to ReFacto.
42 Fi studju li fih il- qawwa ta ’ ReFacto AF, ReFacto u l- attività ta ’ FVIII fil- plażma tal- pazjent tkejlu bl - użu ta ’ l- assaġġ tas- substrat kromoġeniku, intwera li ReFacto AF kien bijoekwivalenti għal ReFacto.
The ratios of geometric least-square means of ReFacto AF-to-ReFacto were 100.6%, 99.5% and 98.1% for K-value, AUCt and AUC∞ (area under the plasma concentration curve from time zero to infinity), respectively.
Il- proporzjonijiet tal- medji least- square ġeometriċi ta ’ ReFacto AF mal- medji ta ’ ReFacto kienu ta ’ 100. 6%, 99. 5% u 98. 1% għall- valur K, AUCt u AUC∞ (żona taħt il- kurva tal- konċentrazzjoni tal - plażma minn żero sal- infinità), rispettivament.
6.2 Incompatibilities
43 6. 2 Inkompatibilitajiet
40 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
2000 IU powder in a 10 ml vial (type 1 glass) with a stopper (butyl) and a flip-off seal (aluminum) and 4 ml of solvent in a pre-filled syringe (type 1 glass) with a plunger stopper (butyl), a tip-cap (butyl) and a sterile vial adapter reconstitution device, a sterile infusion set, alcohol swabs, a plaster and a gauze pad.
2000 IU trab f’ kunjett ta ’ 10 ml (ħġieġ ta ’ tip 1) b’ tapp (butyl) u siġill li tiftħu b’ daqqa ta ’ saba ’ (aluminju) u 4 ml ta ’ solvent f’ siringa mimlija għal- lest (ħġieġ ta ’ tip 1) bi planġer- tapp (butyl), għatu tat- tarf (butyl) u adapter sterili tal- kunjett tat- tagħmir tar- rikostituzzjoni, sett sterili ta ’ l- infużjoni, biċċiet bl- alkoħol, stikka u pad tal- garża.
After reconstitution, the solution is drawn back into the syringe.
44 Wara li tkun rikostitwita, is- soluzzjoni għandha tinġibed lura fis- siringa.
41 ANNEX II
45 ANNESS II
Biovitrum AB (publ) Strandbergsgatan 49 SE-11276 Stockholm Sweden
Biovitrum AB (publ) Strandbergsgatan 49 SE- 11276 Stockholm L- Iżvezja
Wyeth Farma S. A Carretera A-1 Km 23 Desvio Algete Km 1 28700 San Sebastian de los Reyes Madrid Spain
Wyeth Farma S. A Carretera A- 1 Km 23 Desvio Algete Km 1 28700 San Sebastian de los Reyes Madrid Spanja
Or Wyeth Pharmaceuticals New Lane Havant Hants, PO9 2NG United Kingdom
Jew Wyeth Pharmaceuticals New Lane Havant Hants, PO9 2NG Ir- Renju Unit
Medicinal product subject to restricted medical prescription (see Annex I:
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (ara Anness I:
Summary of Product Characteristics, section 4.2)
Sommarju tal- karatteristici tal- prodott, sezzjoni 4. 2)
The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe/ use ReFacto AF, all laboratories that are expected to monitor patients receiving ReFacto AF and all EU Haemophiliac patients associations are provided with Educational packs.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) għandu jiżgura li, meta l- prodott jitpoġġa fuq is- suq, il- Professjonisti kollha fil- Qasam tal- Kura tas- Saħħa li huma mistennija li jagħtu riċetta/ jużaw ReFacto AF, il- laboratorji kollha li huma mistennija li jimmonitorjaw pazjenti li jkunu qed jirċievu ReFacto AF u l- assoċjazzjonijiet kollha tal- pazjenti Emofilijaċi fl- UE, jiġu pprovduti bil - Pakketti Edukattivi.
The educational pack should contain the following • Summary of Product Characteristics and Patient Information Leaflet for ReFacto AF • The educational materials.
Il- pakkett edukattiv għandu jinkludi dawn li ġejjin • Sommarju tal- Karatteristiċi tal- Prodott u Fuljett ta ’ Tagħrif għal Pazjent għal ReFacto AF. • Il- materjal edukattiv.
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 Refacto AF.
The educational materials for Healthcare professionals, patients and haemophiliac patients associations should include the following key elements:
Il- materjal edukattiv għall- Professjonisti fil- qasam tal- kura tas- saħħa, pazjenti u assoċjazzjonijiet ta ’ pazjenti emofilijaċi għandhom jinkludu l- elementi ewlenin li ġejjin:
The main differences between ReFacto AF and ReFacto
Id- differenzi ewlenin bejn ReFacto AF u ReFacto.
Changes highlighted in the Summary of Product Characteristics and Patient Information Leaflet for ReFacto AF.
It- tibdil indikat fis- Sommarju tal- Karatteristiċi tal- Prodott u fil- Fuljett ta ’ Tagħrif għal ReFacto AF.
43
Il- punti viżwali tad- differenzazzjoni fl- ippakkjar għal ReFacto AF meta mqabbel ma ’ ReFacto.
Specific instructions regarding the proper identification, dosing and monitoring of ReFacto AF.
Struzzjonijiet speċifiċi dwar l- identifikazzjoni kif suppost, id- dożaġġ u l- monitoraġġ ta ’ ReFacto AF.
That after switching to ReFacto AF, patients should remain on ReFacto AF and not switch back to ReFacto.
Li wara li taqleb għal ReFacto AF, il- pazjenti għandhom jibqgħu fuq ReFacto AF u mhux jaqilbu lura għal 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.
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.
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.
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.
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.
The importance to report suspected adverse reactions (including inhibitor occurrence) detailing the name and the batch number of the product used.
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.
L - importanza li tirrapporta żbalji tal- mediċina, u l- kawżi u l- konsegwenzi tagħhom.
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.
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.
Additional messages regarding the transition plan for replacement of ReFacto with ReFacto AF in the Member State(s).
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:
Il- programm edukattiv għal- laboratorji għandu jkun fih informazzjoni dwar l- elementi importanti li ġejjin:
The main differences between ReFacto AF and ReFacto.
Id- differenzi ewlenin bejn ReFacto AF u ReFacto.
Specific instructions regarding the proper monitoring of ReFacto AF.
Struzzjonijiet speċifiċi dwar il- monitoraġġ kif suppost ta ’ ReFacto AF.
The potential risks for medication errors in using different assays or laboratory standard for patient monitoring.
Ir- riskji potenzjali fir- rigward ta ’ żbalji tal- mediċina billi tuża assaġġi differenti jew standard tal- laboratorju għall- monitoraġġ tal- pazjent.
Strong recommendation to use the chromogenic substrate assay when monitoring patients.
Rakkomandazzjoni qawwija biex tuża l- assaġġ tas- substrat kromoġeniku meta timmonitorja l- pazjenti.
Information that typically one stage clotting assay results are 20-50% lower than the chromogenic substrate assay results.
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.
The purpose of the laboratory standard.
L- iskop tal- istandard tal- laboratorju.
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.
48 istruzzjonijiet dwar meta tibdel u taqleb għall- istandard tal- laboratorju ta ’ ReFacto AF.
Additional messages regarding the transition plan for replacement of ReFacto with ReFacto AF in the Member State(s)
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 tal- 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.
44 • OTHER CONDITIONS
• KUNDIZZJONIJIET OĦRA
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1 dated 05 December 2005 in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Diċembru, 2005, f’ Modulu 1. 8. 1. tal- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel u waqt li l- prodott jitpoġġa fuq is- suq
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.7 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġjar tar- Riskju L- MAH irid ikun obbligat li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 4. 7 tal- Pjan dwar l- Immaniġġjar tar- Riskju (RMP) ippreżentat f’ Modulu 1. 8. 2. tal- Applikazzjoni tal- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida CHPM dwar is- Sistemi tal- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (PSUR) li jkun imiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Flimkien ma ’ dan, RMP aġġornat għandu jkun sottomess • Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha jkollha impatt fuq l- Ispeċifikazzjoni tas - Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jnaqqsu ir- riskju • Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew tnaqqis tar- riskju) • Fuq talba tal- EMEA
PSUR cycle
Ċiklu tal- PSUR
The MAH is required to submit PSURs at 6-monthly intervals for the first two years.
L- MAH irid jissottometti l- PSURs f’ intervalli ta ’ 6 xhur għall- ewwel sentejn.
Then PSURs should be submited once a year for the following 3 years.
Wara dan il- perjodu, il - PSURs għandhom jiġu sottomessi darba f’ sena għat- tliet snin ta ’ wara.
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
REFACTO AF OUTER CARTON
KARTUNA TA ’ BARRA TA ’ REFACTO AF
ReFacto AF 250 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 Moroctocog alfa (fattur VIII tal- koagulazzjoni rikombinanti uman)
One vial contains 250 IU moroctocog alfa.
Kunjett wieħed fih 250 IU ta ’ moroctocog alfa.