qanastek/EMEA-V3 huggingface dataset:
How has Advate been studied?
Kif ġie studjat Advate?
Advate is similar to another medicine approved in the European Union (EU) called Recombinate, but it is prepared differently so that there are no human- or animal-derived proteins in the medicine.
Advate huwa simili għal mediċina oħra approvata mill- Unjoni Ewropea, imsejjaħ Recombinate, iżda huwa ppreparat b’ mod differenti sabiex ma jkunx hemm proteini ġejjin mill- bniedem jew mill -
Reproduction is authorised provided the source is acknowledged. of bleeding episodes and rated Advate’ s effectiveness in stopping bleeding on a scale from ‘ none’ to ‘ excellent’ in 107 patients, all of whom received Advate.
L- istudju ħares ukoll lejn numru ta ’ episodji ta ’ fsada ul- effikaċja ta ’ Advate biex iwaqqaf id- demm ġiet valutata fuq skala minn ‘ xejn ’ għal ‘ eċċellenti ’ f’ 107 pazjenti, li kollha rċevew Advate.
Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of six years.
Tliet studji addizzjonali ħarsu lejn l- użu tal- mediċina fil- prevenzjoni ta ’ fsada u ta ’ operazzjoni f’ pazjenti b’ emofilja A qawwija jew moderata, inkluż studju fuq 53 tifel u tifla ta ’ taħt is- sitt snin.
What benefit has Advate shown during the studies?
X’ benefiċċji ta ’ Advate ħarġu minn dawn l- istudji?
In the main study, the effectiveness of Advate in the prevention of bleeding was rated as ‘ excellent’ or ‘ good’ in 86% of the 510 new bleeding episodes.
Fl- istudju ewlieni, l- effikaċja ta ’ Advate fil- prevenzjoni ta ’ fsada ġiet stmata bħala ‘ eċċellenti ’ jew ‘ tajba ’ f’ 86% ta ’ 510 episodji ġodda ta ’ fsada.
In addition, 81% of these bleeding episodes required only a single treatment with Advate.
Barra minn hekk, 81% ta ’ dawn l- episodji ta ’ fsada kienu jeħtieġu biss trattament wieħed ta ’ Advate.
The additional studies confirmed Advate’ s effectiveness, including in children under six years of age.
L- istudji addizzjonali kkonfermaw l- effikaċja ta ’ Advate, inkluż fi tfal ta ’ taħt is- sitt snin.
What is the risk associated with Advate?
X’ inhuma r- riskji marbuta ma ’ Advate?
Haemophilia A patients may develop antibodies (inhibitors) to factor VIII.
Pazjenti bl- emofilja A jistgħu jiżviluppaw antikorpi (impedituri) għal fattur VIII.
An antibody is a protein produced by the body in reaction to unknown agents as part of the natural defence system of the body.
Antikorp huwa proteina prodotta mill- ġisem bħala reazzjoni għal aġenti mhux magħrufa bħala parti mis- sistema naturali ta ’ difiża tal- ġisem.
If antibodies develop, Advate will not work effectively.
Jekk jiżviluppaw antikorpi, Advate ma jaħdimx b’ mod effettiv u jista ’ jirriżulta f’ kontroll imnaqqas jew ineżistenti tal- fsada.
The most common side effects with Advate (seen in between 1 to 10 patients in 100) are dizziness, headache, pyrexia (fever) and the presence of antibodies against factor VIII.
L- aktar effetti sekondarji komuni b’ Advate (dehru f’ madwar 1 sa 10 pazjenti f’ 100) huma sturdament, uġigħ ta ’ ras, pireksja (deni) u l- preżenza ta ’ antikorpi kontra l- fattur VIII.
Hypersensitivity (allergic reactions) has sometimes been seen in patients treated with factor VIII-containing products.
Ipersensittività (reazzjonijiet allerġiċi) kultant dehret f’ pazjenti ttrattati bi prodotti li fihom il- fattur VIII.
For the full list of all side effects reported with Advate, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrapporti b’ Advate, ara l- Fuljett ta ’ Tagħrif mehmuż mal- pakkett.
Advate should not be used in people who may be hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.
Advate m’ għandux jintuża minn persuni li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal fattur VIII tal- koagulazzjoni tal- bniedem, għal proteina tal- ġurdien jew tal- ħamster, jew għal kwalunkwe sustanza oħra tiegħu.
Why has Advate been approved?
Għaliex ġie approvat Advate?
The Committee for Medicinal Products for Human Use (CHMP) decided that Advate’ s benefits are greater than its risks for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Advate għat- trattament u l- profilassi ta ’ fsada f’ pazjenti b’ emofilja A (defiċjenza konġenitali tal - fattur VIII) huma akbar mir- riskji tiegħu.
The Committee recommended that Advate be given marketing authorisation.
Il- Kumitat irrakkomanda li Advate jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Advate:
Aktar tagħrif dwar Advate:
The European Commission granted a marketing authorisation valid throughout the EU for Advate to Baxter AG on 2 March 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Advate lil Baxter AG fit- 2 ta ’ Marzu 2004.
The marketing authorisation was renewed on 2 March 2009.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 2 ta ’ Marzu 2009.
The full EPAR for Advate is available here.
L- EPAR sħiħ għal Advate jista ’ jiġi kkonkultat hawnhekk.
This summary was last updated in 03-2009.
Dan is- sommarju ġie aġġornat f’ 03- 2009.
Powder and solvent for solution for injection
Trab u solvent għal soluzzjoni għal injezzjoni
Intravenous use
Jingħata ġol- vina
powder: vial (glass); solvent: vial (glass)
trab: kunjett (ħġieġ) solvent: kunjett (ħġieġ)
powder:
trab:
250 IU; solvent:
250 IU solvent:
1 vial + 1 vial + reconstitution device
1 kunjett +1 kunjett + tagħmir għar- rikostituzzjoni
Powder and solvent for solution for injection
Trab u solvent għal soluzzjoni għallinjezzjoni
500 IU; solvent:
500 IU Solvent:
1000 IU; solvent:
1000 IU solvent:
1 vial + 1 vial + reconstitution device
1 fjala +1 fjala + tagħmir għar- rikostituzzjoni
1500 IU; solvent:
1500 IU solvent:
2000 IU; solvent:
2000 IU solvent:
1 vial + 1 vial + reconstitution device
1 kunjett +1 kunjett + tagħmir għar -
powder: vial (glass); solvent: vial (glass)
trab: kunjett (ħġieġ) solvent: kunjett( ħġieġ)
3000 IU; solvent:
3000 IU solvent:
1 vial + 1 vial + reconstitution device
1 kunjett +1 kunjett + tagħmir għar - rikostituzzjoni
ADVATE 250 IU powder and solvent for solution for injection
ADVATE 250 IU trab u solvent għal soluzzjoni għall- injezzjoni.
Each vial contains nominally 250 IU* human coagulation factor VIII (rDNA), octocog alfa**.
Ġeneralment kull kunjett fih 250 IU * ta ’ fattur VIII tal- koagulazzjoni tal- bniedem (rDNA), octocog alfa **.
After reconstitution, each ml solution for injection contains approximately 50 IU octocog alfa. * The potency (International Units) is determined using the chromogenic assay against an in-house standard that is referenced to the WHO standard.
Wara r- rikostituzzjoni, kull ml ta ’ soluzzjoni għall- injezzjoni fih madwar 50 IU octocog alfa. * Il- qawwa (Unitajiet Internazzjonali) hi stabbilita permezz ta ’ assaġġ kromoġeniku li jitqabbel mal- istandard intern li għandu bħala referenza l- istandard ta ’ WHO.
The specific activity is approximately 4,000- 10,000 IU/ mg protein. ** Human coagulation factor VIII produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells.
L- attività speċifika hi madwar 4, 000- 10, 000 IU/ mg proteina. ** Il- fattur VIII ta ’ koagulazzjoni uman magħmul minn teknoloġija tad- DNA rikombinanti f’ ċelluli tal- Ovarji ta ’ Ħamsters Ċiniżi (CHO).
Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation.
Hu ippreparat mingħajr iż- żieda ta ’ proteina (eksoġina) derivata mill- bniedem jew mill- annimali fil- proċess ta ’ tnissil ta ’ razez ċellulari, purifikazzjoni, u formulazzjoni finali.
For a full list of excipients, see section 6.1.
0. 45 mmol sodium (10 mg) kull kunjett Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
White to off-white friable powder.
Trab abjad għal offwajt li jitfarrak.
After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3.
Wara r- rikostituzzjoni, is- soluzzjoni hi ċara, mingħajr kulur, ħielsa minn partiċelli barranin u għandha pH ta 'bejn 6. 7 sa 7. 3.
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Kura u profilassi ta ’ emorraġiji f’ pazjenti b’ emofilja A (nuqqas konġenitali tal- fattur VIII).
ADVATE does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand disease.
ADVATE ma fihx il- fattur von Willebrand fi kwantitajiet farmakoloġiċi effettivi u għaldaqstant mhuwiex indikat fil- mard ta ’ von Willebrand.
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
Il- kura b' ADVATE għandha tinbeda taħt is- superviżjoni ta 'tabib li għandu esperjenza fit - trattament tal- emofilja.
Posology The posology and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient’ s clinical condition.
Pożoloġija Il- pożoloġija u t- tul tat- terapija ta ’ sostituzzjoni jiddependu fuq il- qawwa tan- nuqqas ta ’ fattur VIII, fuq il- lokazzjoni u l- firxa tal- fsada u fuq il- kundizzjoni klinika tal- pazjent.
On demand treatment The dose of factor VIII (FVIII)is expressed in International Units (IU), which are related to the WHO standard for factor VIII products.
Trattament mitlub Id- doża ta ’ fattur VIII (FVIII) hija espressa f’ Unitajiet Internazzjonali (IU), li huma konnessi mal- istandard tal- WHO għal prodotti ta ’ fattur VIII.
Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IUs (relative to the international standard for factor VIII in plasma).
L- attività ta ’ fattur VIII fil- plażma hija espressa jew bħala perċentwali (imqabbel mal- plażma uman normali) jew f’ IU (imqabbel mal- Istandard Internazzjonali għall- fattur VIII fil- plażma).
One IU of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
IU waħda tal- attività ta ’ fattur VIII hija ekwivalenti għal dik il- kwantità ta ’ fattur VIII f’ ml ta ’ plażma uman normali.
The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU
Il- kalkolu tad- doża meħtieġa ta ’ fattur VIII hija bbażata fuq is- sejba empirika li IU
2 factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/ dl.
2 waħda ta ’ fattur VIII għal kull kg ta ’ piż tal- ġisem ittella ’ l- attività tal- fattur VIII fil- plażma b’ 2 IU/ dl.
The dose is determined using the following formula:
Id- doża hija stabbilita permezz tal- formola li ġejja:
Required units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5
Unitajiet Meħtieġa (IU) = piż tal- ġisem (kg) x żieda mixtieqa ta ’ fattur VIII (%) x 0. 5.
In case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in% of normal or IU/ dl) in the corresponding period.
Jekk iseħħu l- każijiet emorraġiċi li ġejjin, l- attività ta ’ fattur VIII m’ għandhiex taqa ’ taħt il- livell tal- attività fil- plażma indikat (f ’% tan- normal jew IU/ dl) fil- perijodu korrispondenti.
The followingtable 1 can be used to guide dosing in bleeding episodes and surgery:
It- tabella 1 li ġejja tista ’ tintuża bħala gwida għad- doża f’ każijiet ta ’ emorraġija u kirurġija:
Table 1 Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/ type of surgical procedure Haemorrhage
Tabella 1 Gwida għal dożaġġ u episodji ta ’ emorraġija u kirurġija Grad ta ’ emorraġija/ tip ta ’
Factor VIII level required (% or IU/ dl)
Livell ta ’ fattur VIII
Frequency of doses (hours)/ duration of therapy (days)
Frekwenza tad- dożi (sigħat) / dewmien
Early haemarthrosis, muscle bleeding or oral bleeding.
mixtieq (% jew IU/ dl) tat- terapija (ġranet)
20 – 40
Emoartrożi bikrija, emorraġija fil- muskoli jew emorraġija fil- ħalq.
Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for at least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved.
20 – 40 Irrepeti l- injezzjonijiet kull 12 sa 24 siegħa (8 sa 24 siegħa fil- każ ta 'pazjenti li huma taħt is- 6 snin) għal mill- anqas ġurnata, sakemm l- episodju ta' emorraġija, kif indikat mill- uġigħ, jirrisolvi ruħu jew jinkiseb fejqan.
More extensive haemarthrosis, muscle bleeding or haematoma.
Emoartrożi aktar estensiva, emorraġija fil- muskoli jew ematoma.
Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for 3 – 4 days or more until pain and acute disability are resolved.
Irrepeti l- injezzjonijiet kull 12 sa 24 siegħa (8 sa 24 siegħa fil- każ ta 'pazjenti li huma taħt is- 6 snin) għal 3 - 4 ijiem sakemm l- uġigħ jew diżabilità akuta jirrisolvu ruħhom.
Life-threatening haemorrhages.
għall- ħajja.
Repeat injections every 8 to 24 hours (6 to 12 hours for patients under the age of 6) until threat is resolved.
Irrepeti l- injezzjonijiet kull 8 sa 24 siegħa (6 sa 12- il siegħa fil- każ ta 'pazjenti li huma taħt is- 6 snin) sakemm it- theddida tirrisolvi ruħha.
Minor Including tooth extraction.
Minuri Inkluż il- qlugħ ta ’ sinna.
Every 24 hours (12 to 24 hours for patients under the age of 6), at least 1 day, until healing is achieved.
Kull 24 siegħa (12 sa 24 siegħa fil- każ ta 'pazjenti li huma taħt is- 6 snin), għal mill - anqas ġurnata, sakemm jinkiseb fejqan.
Major
Irrepeti l- injezzjonijiet kull 8 sa 24 Maġġuri
Repeat injections every 8 to 24 hours (6 to 24 hours for patients under the age of 6) until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/ dl).
li huma taħt is- 6 snin) sakemm jinkiseb fejqan adegwat tal- ferita, imbagħad kompli t- terapija għal mill- anqas 7 ijiem oħra biex iżżomm attività tal- fattur VIII ta '30% sa 60% (IU/ dl).
The dose and frequency of administration should be adapted to the clinical response in the individual case.
Id- doża u l- frekwenza tal- amministrazzjoni għandhom ikunu adattati għar- reazzjoni klinika fil- każ individwali.
Under certain circumstances (e. g. presence of a low-titre inhibitor), doses larger than those calculated using the formula may be necessary.
F’ ċerti ċirkostanzi (eż. il- preżenza ta ’ impeditur tat- tajter baxx) jistgħu jkunu neċessarji dożi akbar minn dawk ikkalkolati meta tintuża l- formula.
During the course of treatment, appropriate determination of plasma factor VIII levels is advised to guide the dose to be administered and the frequency of repeated injections.
Matul il- kors tal- kura, hija rakkomandata determinazzjoni xierqa tal- livelli tal- fattur VIII fil- plażma biex tiggwida d- doża li għandha tkun amministrata u l- frekwenza tal- injezzjonijiet ripetuti.
In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of plasma factor VIII activity assay is indispensable.
F’ każ ta ’ interventi kirurġiċi maġġuri b’ mod partikolari, is- sorveljanza preċiża tat- terapija ta ’ sostituzzjoni permezz ta ’ analiżi fuq l- attività tal- fattur VIII fil- plażma hija indispensabbli.
Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Pazjenti individwali jista ’ jkollhom reazzjoni differenti għall- fattur VIII, jilħqu livelli differenti ta ’ irkupru in vivo u juru half lives differenti.
3 Prophylaxis For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIIIper kg body weight at intervals of 2 to 3 days.
3 Profilassi Għal profilassi fit- tul kontra l- emorraġija f’ pazjenti b’ emofilja A severa, id- dożi li ġeneralment jingħataw huma 20 sa 40 IU ta ’ fattur VIII għal kull kg ta ’ piż tal- ġisem f’ intervalli ta ’ 2 jew 3 ijiem.
In patients under the age of 6, doses of 20 to 50 IU of factor VIII per kg body weight 3 to 4 times weekly are recommended.
F' pazjenti li huma taħt is- 6i snin, huma rakkomandati dożi ta '20 sa 50 IU ta' fattur VIII għal kull kg ta 'piż tal- ġisem 3 jew 4 darbiet fil- ġimgħa.
Patients should be monitored for the development of factor VIII inhibitors.
Il- pazjenti għandhom ikunu monitorati għall- iżvilupp ta ’ impedituri tal- fattur VIII.
If the expected factor VIII plasma activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present.
Jekk il- livelli mistennija ta ’ attività tal- fattur VIII fil- plażma ma jinkisbux, jew jekk l- emorraġija ma tkunx ikkontrollata b’ doża xierqa, għandu jsir assaġġ sabiex jiġi stabbilit jekk impeditur ta ’ fattur VIII hux preżenti.
In patients with high levels of inhibitor, factor VIII substitution therapy may not be effective and other therapeutic options should be considered.
F’ pazjenti b’ livelli għoljin ta ’ impedituri, it- terapija fattur VIII tista ’ ma tkunx effettiva u għandhom ikunu kkunsidrati għażliet terapewtiċi oħrajn.
The management of such patients should be directed by physicians with experience in the care of patients with haemophilia (see section 4.4).
Il- ġestjoni ta 'dawn il- pazjenti għandha tkun immexxija minn tobba li jkollhom esperjenza fil- kura ta' pazjenti bl- emofilja (ara wkoll sezzjoni 4. 4).
Method of administration ADVATE should be administered via the intravenous route.
Mod ta ’ kif jingħata ADVATE għandu jkun mogħti ġol- vina.
In case of administration by a non health care professional appropriate training is needed.
F’ każ li għandu jingħata minn persuna li mhix professjonista tal- kura tas- saħħa, hu meħtieġ li tingħata taħriġ.
The rate of administration should be determined to ensure the comfort of the patient up to a maximum of 10 ml/ min.
Ir- rata tal- amministrazzjoni għandha tkun stabbilita, biex tiġi żgurata l- kumdità tal- pazjent sa massimu ta ’ 10 ml/ min.
In the interest of patients, it is recommended that every time ADVATE is administered, the name and batch number of the product should be recorded.
Fl- interess tal- pazjenti, huwa rakkomandat li kull darba li ADVATE jingħata, l- isem u n- numru tal- lott tal- prodott għandu jiġi rikordat.
For instructions for reconstitution prior to administration, see section 6.6.
Għal istruzzjonijiet dwar ir- rikostituzzjoni qabel ma jingħata, ara sezzjoni 6. 6
Hypersensitivity to the active substance or to any of the excipients or to mouse or hamster proteins.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanza mhux attiva jew għall- proteini tal- ġurdien jew tal- ħamster.
As with any intravenous protein product allergic type hypersensitivity reactions are possible.
Bħalma huwa l- każ b’ kull prodott ta ’ proteina li jintuża ġol- vina reazzjonijiet allerġiċi ta ’ sensittività eċċessiva huma possibbli.
The product contains traces of mouse and hamster proteins.
Il- prodott fih traċċi ta ’ proteini tal- ġurdien u tal- ħamster.
Patients should be informed of the signs of immediate-type hypersensitivity reactions including hives, pruritus, generalised urticaria, angioedema, hypotension (e. g. dizziness or syncope), shock and acute respiratory distress (e. g. tightness in the chest, wheezing).
Il- pazjenti għandhom ikunu mgħarrfa dwar is- sinjali ta ’ reazzjonijiet ta ’ sensittività eċċessiva tip immedjat li jinkludu ħorriqija, ħakk tal- ġilda, urtikarja mxerrda, anġjoedema, pressjoni baxxa ħafna (eż. sturdament jew sinkope), xokk u problemi respiratorji akuti (eż. rassa fis- sider, tħarħir).
If these symptoms occur, they should be advised to discontinue use of the product immediately and contact their physicians.
Jekk dawn is - sintomi jseħħu, għandhom jingħataw parir biex iwaqqfu immedjatament l- użu tal- prodott u jikkuntattjaw lit- tobba tagħhom.
In case of anaphylactic shock, the current medical standards for shock treatment should be implemented (see section 4.8).
F’ każ ta ’ xokk anafilattiku, l- istandards mediċi attwali għall- kura ta ’ xokk għandhom ikunu implimentati (ara sezzjoni 4. 8).
The formation of neutralising antibodies (inhibitors) against factor VIII is a known complication in the management of individuals with haemophilia A.
Il- formazzjoni ta ’ antikorpi li jinnewtralizzaw (impedituri) kontra fattur VIII hija kumplikazzjoni magħrufa fil- ġestjoni ta ’ individwi b’ emofilja A.
These inhibitors are usually IgGs directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified Bethesda assay.
Dawn l- impedituri huma normalment immunoglobulini IgG diretti lejn l- attività prokoagulanti tal- fattur VIII, li jiġu kwantifikabbli f’ Unitajiet Bethesda (BU) għal kull ml ta ’ plażma billi tintuża l- analiżi modifikata ta ’ Bethesda.
In patients who develop inhibitors to factor VIII, the condition may manifest itself as an insufficient clinical response.
F’ pazjenti li jiżviluppaw impedituri għal fattur VIII, il- kundizzjoni tista ’ timmanifesta ruħha bħala rispons kliniku mhux suffiċjenti.
In such cases, it is recommended that a specialised haemophilia centre be contacted.
F’ każijiet bħal dawn, huwa rakkomandat li ċentru speċjalizzat tal - emofilja jiġi kkuntattjat.
The risk of developing inhibitors is correlated to the extent of exposure to factor VIII, the risk being highest within the first 20 exposure days, and to other genetic and environmental factors.
Ir- riskju tal- iżvilupp ta ’ impedituri huwa korelatat ma ’ kemm kien hemm espożizzjoni għall- fattur VIII, fejn ir- riskju huwa l- ogħla fi żmien l- ewwel 20 jum tal- espożizzjoni, u ma ’ fatturi ġenetiċi u ambjentali oħra.
Rarely, inhibitors may develop after the first 100 exposure days.
F’ każijiet rari, impedituri jistgħu jiżviluppaw wara l- ewwel 100 jum tal- espożizzjoni.
Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.
Każijiet ta ’ impedituri rikorrenti (titru baxx) ġew osservati wara li pazjenti li kienu trattati qabel inqalbu minn prodott ta ’ fattur VIII għal ieħor u li kellhom aktar minn 100 jum ta ’ espożizzjoni u li għandhom storja ta ’ żvilupp ta ’ impedituri.
Patients treated with coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests (see section 4.8).
Pazjenti kkurati b’ fattur VIII tal - koagulazzjoni għandhom ikunu eżaminati b’ attenzjoni għall- iżvilupp ta ’ impedituri b’ osservazzjonijiet kliniċi xierqa u testijiet tal- laboratorju (ara wkoll sezzjoni 4. 8).
After reconstitution this medicinal product contains 0.45 mmol sodium (10 mg) per vial.
Wara r- rikostituzzjoni dan il- prodott mediċinali fih 0. 45 mmol ta 'sodju (10 mg) kull kunjett.
To be taken into consideration by patients on a controlled sodium diet.
Dan għandu jittieħed in konsiderazzjoni mill- pazjenti fuq dieta ta 'sodju kkontrollat.
No interaction studies have been performed with ADVATE..
Ma sarux studji dwar l- effett ta ’ ADVATE jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott.
4 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
Animal reproduction studies have not been conducted with factor VIII.
Ma sarux studji fuq ir- riproduzzjoni tal- annimali b’ fattur VIII.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of Factor VIII during pregnancy and breast-feeding is not available.
Minħabba każijiet rari ta 'emofilja A fin- nisa, esperjenza li tirrigwarda l- użu ta ’ fattur VIII waqt it- tqala u t- treddigħ mhix disponibbli.
Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Għaldaqstant, il- fattur VIII m’ għandux jintuża waqt it- tqala u t- treddigħ għajr biss meta ikun hemm bżonn ċar għalih.
ADVATE has no influence on the ability to drive and use machines.
ADVATE ma jaffettwax il- ħila biex issuq u tħaddem magni.
(see section 4.4).
Bħalma huwa l- każ b’ kull prodott ta ’ proteina li jintuża ġol- vina reazzjonijiet allerġiċi ta ’ sensittività eċċessiva huma possibbli (ara sezzjoni 4. 4).
During clinical studies with ADVATE, a total of 56 adverse drug reactions (ADRs) were reported in 27 of 234 unique treated patients.
Waqt studji kliniċi b' ADVATE, kienu rrapportati total ta '56 reazzjoni avversa għall- mediċina (ADRs) f' 27 minn 234 pazjent ittrattat b’ mod uniku.
The ADRs that occurred in the highest number of patients were development of factor VIII inhibitors (5 patients), all occurring in previously untreated patients who had elevated risk of inhibitor development, headache (5 patients), fever and dizziness (3 patients each).
L- ADRs li seħħew fl- akbar numru ta 'pazjenti kienu l - iżvilupp ta ’ impedituri ta ’ fattur VIII (5 pazjenti), li kollha seħħew f' pazjenti mhux ikkurati qabel li kellhom riskju ogħla ta' żvilupp ta 'impedituri, uġigħ ta' ras (5 pazjenti), deni u sturdament (3 pazjenti kull wieħed).
Of the 56 ADRs, none were reported in neonates, 16 were reported in 13/ 32 infants, 7 were reported in 4/ 56 children, 8 were reported in 4/ 31 adolescents and 25 were reported in 14/ 94 adults.
Mis- 56 ADR, l- ebda wieħed ma kien irrapportat fi trabi li għadhom jitwieldu, 16 kienu rrapportati fi 13/ 32 tarbija, 7 kienu rrapportati f' 4/ 56 tifel/ tifla, 8 kienu rrapportati f' 4/ 31 adoloxxent/ a u 25 kienu rrapportati f' 14/ 94 adult/ a.
Frequency categories are defined according to the following convention: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be calculated from the available data).
Il- kategoriji ta ’ frekwenza huma mfissra skont il- konvenzjoni li ġejja: komuni ħafna (≥1/ 10), komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1, 000 sa < 1/ 100), rari ((≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħruf (ma jistax jiġi stmat mit- tagħrif disponibbli).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skont is- serjetà tagħhom, bl- aktar serji jitniżżlu l - ewwel
The following table 2 provides the frequency of adverse drug reactions in clinical trials:
It- tabella 2 li ġejja tipprovdi l- frekwenza ta ’ reazzjonijiet avversi għall- mediċina fi provi kliniċi:
Table 2 Frequency of adverse drug reactions (ADRs) in clinical trials
Tabella 2 Frekwenza ta ’ reazzjonijiet avversi għal mediċina (ADRs) fi provi kliniċi
Patients
Pazjenti
Adverse Experience Rate
tal- Klassifika ta '
Frequency
l- Organi
(% patients)a
(%
Infections and infestations Blood and lymphatic system disorders
Infezzjonijiet u infestazzjonijiet Disturbi tad- demm u tas- sistema limfatika
Influenza Laryngitis Lymphangitis
Influwenza Larinġite Limfanġite
0.43 0.43 0.43
0. 43 0. 43 0. 43
Uncommon Uncommon Uncommon
Mhux komuni Mhux komuni Mhux komuni
Headache Dizziness Memory impairment Tremor Migraine Dysgeusia
Uġigħ ta 'ras Sturdament Indeboliment tal- memorja Rogħda Emigranja Togħma ħażina
2.14 1.28 0.43 0.43 0.43 0.43
2. 14 1. 28 0. 43 0. 43 0. 43 0. 43
Common Common Uncommon Uncommon Uncommon Uncommon
Komuni Komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni
Eye disorders Vascular disorders
Disturbi fl- għajnejn
Eye inflammation Haematoma
Infjammazzjoni tal- għajnejn
0.43 0.43
Mhux komuni
Uncommon Uncommon
Disturbi vaskulari
MedDRA Standard System Organ Class
0. 43 0. 43 0. 43
Adverse reaction
Mhux komuni Mhux komuni Mhux komuni
Adverse Experience Rate
Disturi respiratorji, toraċiċi u medjastinali
Frequency
Dispnea
0.43 0.43
0. 43
Respiratory, thoracic and Dyspnoea mediastinal disorders
Disturbi gastrointestinali Dijarea Uġigħ fin- naħa ta ’ fuq tal- addome
0.43
0. 85 0. 43
Gastrointestinal Diarrhoea disorders Abdominal pain upper Nausea Vomiting Skin and subcutaneous Pruritus tissue disorders Rash Hyperhidrosis Dermatitis diaper General disorders and Pyrexia administration site Oedema peripheral conditions
Nawsja Rimettar Disturbi fil- ġilda u Ħakk fit- tessuti ta 'taħt il- ġilda Raxx Tagħriq żejjed Dermatitis diaper Disturbi ġenerali u Deni kondizzjonijiet ta' mnejn Edima periferika jingħata
2 1 1 1 2 2 1 1 3 1
1 1 2 2 1 1 3 1
0.85 0.43 0.43 0.43 0.85 0.85 0.43 0.43 1.28 0.43
0. 43 0. 43 0. 85 0. 85 0. 43 0. 43 1. 28 0. 43
Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Common Uncommon
Mhux komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni Komuni Mhux komuni
Chest pain Chills Feeling abnormal Investigations Anti-factor VIII antibody positive
Uġigħ fis- sider Tertir Sensazzjoni ta 'anormalità Stħarriġ Antikorp kontra fattur VIII pożittiv
0.43 0.43 0.43 2.14
0. 43
Uncommon Uncommon Uncommon Common
Mhux komuni
Alanine aminotransferase increased
Tnaqqis fil- livell ta 'fattur VIII tal- koagulazzjonib
0.43
0. 43
Coagulation factor VIII level decreasedb
Ematokrit imnaqqas Test tal- laboratorju abnormali
0.43
Avversi
Uncommon
l- Organi
Haematocrit decreased Laboratory test abnormal Injury, poisoning and Post procedural procedural complications complication
Korriment, avvelenament Kumplikazzjonijiet wara u kumplikazzjonijiet l- proċedura
0.43 0.43 0.43
0. 43
Uncommon Uncommon Uncommon
Mhux komuni
Post procedural haemorrhage
proċedurali Emorraġija wara l- proċedura
Procedural site reaction
Reazzjoni fil- post tal- proċedura
a) Percent of patients calculated based on total number of unique patients (234). b) The unexpected decrease in coagulation factor VIII levels occurred in one patient during continuous infusion of ADVATE following surgery (postoperative days 10-14).
a) Perċentwali ta ’ pazjenti kkalkulati msejjes fuq in- numru totali ta 'pazjenti uniċi (234). b) It- tnaqqis mhux mistenni fil- livelli ta' fattur VIII tal- koagulazzjoni seħħ f' pazjent wieħed waqt infużjoni kontinwa ta 'ADVATE wara l- kirurġija (ġranet ta' wara l- operazzjoni 10- 14).
Haemostasis was maintained at all times during this period and both plasma factor VIII levels and clearance rates returned to appropriate levels by postoperative day 15.
L - emostażi nżammet f’ kull waqt matul dan il- perijodu u kemm il- livelli ta ’ fattur VIII fil- plażma kif ukoll ir- rati ta 'eliminazzjoni ġew lura għal- livelli normali sal- 15- il jum ta ’ wara l - operazzjoni.
Factor VIII inhibitor assays performed after completion of continuous infusion and at study termination were negative.
L- analiżi fuq l- impeditur tal- fattur VIII li saru wara li tlestiet l- infużjoni kontinwa u meta ntemm l- istudju tat riżultat negattiv.
6 The immunogenicity of ADVATE was evaluated in previously treated patients.
Żvilupp ta ’ Impeditur L- immunoġeniċità ta 'ADVATE ġiet evalwata f' pazjenti kkurati qabel.
During clinical trials with ADVATE in 145 paediatric and adult patients 2 diagnosed with severe to moderately severe haemophilia A (FVIII ≤ 2%), with previous exposure to factor VIII concentrates ≥ 150 days, one patient developed a low-titre inhibitor (2.4 BU in the modified Bethesda assay) after 26 exposure days to ADVATE.
Waqt provi kliniċi b' ADVATE f' 145 pazjent 2 pedjatriku u adult, iddijanjostikati b' emofilja A severa għal severa moderatament (FVIII ≤ 2%), b' espożizzjoni preċedenti għal konċentrati tal- fattur VIII ≥ 150 jum, pazjent wieħed żviluppa tajter baxx għal impeditur (2. 4 BU fl- analiżi Bethesda modifikata) wara 26 jum ta 'espożizzjoni għal ADVATE.
Follow-up inhibitor tests in this patient after withdrawal from the study were negative.
It- testijiet dwar l- impeditur li saru wara f' dan il- pazjent wara l- irtirar mill- istudju kienu negattivi.
Also, in 53 paediatric patients under the age of 6, also diagnosed with severe to moderately severe haemophilia A (FVIII ≤ 2%), with previous exposure to factor VIII concentrates ≥ 50 days, no FVIII inhibitor was detected.
Barra minn hekk, fi 53 pazjent pedjatriku taħt is- 6 snin, iddijanjostikati wkoll b' emofilja A severa għal severa moderatament (FVIII≤ 2%), b' espożizzjoni qabel għal konċentrati tal- fattur VIII ≥ 50 jum, ma nstab l- ebda impeditur ta 'FVIII.
In previously untreated patients in an ongoing clinical study, 5 (20%) of 25 patients who received ADVATE developed inhibitors to factor VIII.
F' pazjenti mhux ikkurati qabel fi studju kliniku għadu sejjer, 5 (20%) minn 25 pazjent li rċevew ADVATE żviluppaw impedituri għal- fattur VIII.
Of those, 4 were high-titre (≥ 5 BU) and 1 was low-titre (< 5 BU).
Minn dawn, 4 kienu tajter għoli (≥5 BU) u 1 kien tajter baxx (< 5 BU).
The frequency of FVIII inhibitors detected so far is within the expected and previously observed range.
Il- frekwenza tal- impedituri ta 'FVIII misjuba sa issa hija fil- medda mistennija u osservata qabel.
The patient’ s immune response to trace amounts of contaminating proteins was analysed by examining titres of antibodies to these proteins, laboratory parameters and reported adverse events.
Ir- rispons immunitarju tal- pazjenti għal traċċi ta 'proteini kontaminanti kien analizzat billi ġew eżaminati tajters ta' antikorpi għal dawn il- proteini, parametri tal- laboratorju u episodji avversi rrapportati.
Of the 182 treated patients who were assessed for antibodies to Chinese hamster ovary (CHO) cell protein, 3 showed a statistically significant upward trend in titres by linear regression analysis and 4 displayed sustained peaks or transient spikes.
Mill- 182 pazjent ikkurat li ġew eżaminati għal antikorpi għall- proteina taċ- ċellula tal - ovarju tal- ħamster Ċiniż (CHO), 3 urew xejra 'l fuq statistikament sinifikanti fit- tajters b' analiżi ta' rigressjoni lineari u 4 urew qċaċet sostenuti jew ponot għaddiena.
One patient had both a statistically significant upward trend and displayed a sustained peak in anti-CHO protein antibody level, but no other signs or symptoms indicative of an allergic or hypersensitivity response.
Pazjent wieħed kellu kemm xejra 'l fuq statistikament sinifikanti kif ukoll wera quċċata sostenuta fil- livell ta' antikorpi kontra l- proteini taċ- ċellula CHO, iżda l- ebda sinjali jew sintomi oħra li juru rispons allerġiku jew ta 'sensittività eċċessiva.
Of the 182 treated patients who were assessed for antibodies to murine IgG, 10 showed a statistically significant upward trend by linear regression analysis and 2 displayed a sustained peak or transient spike.
Mill- 182 pazjent kkurat li ġew eżaminati għal antikorpi għall- IgG tal- ġrieden, 10 urew xejra 'l fuq statistikament sinifikanti b' analiżi ta' rigressjoni lineari u 2 urew quċċata sostnuta jew ponta għaddiena.
One patient had both a statistically significant upward trend and displayed a sustained peak in anti-murine IgG antibody level.
Pazjent wieħed kellu kemm xejra 'l fuq statistikament sinifikanti kif ukoll wera quċċata sostnuta fil- livell tal- antikorpi kontra l- IgG tal- ġrieden.
Four of these patients reported isolated events of urticaria, pruritus, rash, and slightly elevated eosinophil counts amongst numerous repeated exposures to the study product.
Erbgħa minn dawn il- pazjenti rrapportaw episodji iżolati ta 'urtikarja, ħakk, raxx, u livelli daqsxejn għoljin ta' eosinofil fost bosta espożizzjonijiet ripetuti għall- prodott studjat.
As with other intravenous products, allergic type hypersensitivity reactions, including anaphylaxis/ anaphylactoid reactions, have been reported with ADVATE (frequency not known).
Bħal fil- każ ta 'prodotti oħra li jingħataw ġol- vina, reazzjonijiet allerġiċi ta' sensittività eċċessiva, fosthom anafilassi/ reazzjonijiet anafilattojdi, kienu rrapportati b' ADVATE (bi frekwenza mhux magħrufa).
4.9 Overdose
7 4. 9 Doża eċċessiva
No symptoms of overdose with recombinant coagulation factor VIII have been reported.
L- ebda każ ta ’ doża eċċessiva bil- fattur VIII tal- koagulazzjoni rikombinanti uman ma ġie rrapportat.
Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII.
Kategorija farmakoterapewtika: antiemorraġiċi: fattur VIII tal- koagulazzjoni tad- demm.
The factor VIII/ von Willebrand Factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions. ADVATE contains recombinant coagulation factor VIII (octocog alfa), a glycoprotein that is biologically equivalent to the factor VIII glycoprotein found in human plasma.
ADVATE fih il- fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa), glikoproteina li hi bijoloġikament ekwivalenti għal glikoproteina ta ’ fattur VIII li tinsab fil- plażma tal- bniedem.
Octocog alfa is a glycoprotein consisting of 2332 amino acids with an approximate molecular mass of 280 kD.
Octocog alfa hija glikoproteina li tikkonsisti f’ 2, 332 aċidu amminiku b’ piż molekulari ta ’ madwar 280 kD.
When infused into a haemophilia patient, octocog alfa binds to endogenous von Willebrand Factor in the patient’ s circulation.
Meta jingħata b’ infużjoni ġo pazjent b’ emofilja, octocog alfa jorbot mal- fattur endoġenu von Willebrand fiċ- ċirkolazzjoni tal- pazjent.
Activated factor VIII acts as a Cofactor for activated Factor IX, accelerating the conversion of Factor X to activated Factor X.
Il- fattur VIII attivat jaħdem bħala Ko- fattur għall- Fattur IX attivat, jaċċellera l- bdil ta 'Fattur X għal Fattur X attivat.
Activated Factor X converts prothrombin to thrombin.
Il- Fattur X attivat jaqleb il- protrombina fi trombina.
Thrombin then converts fibrinogen into fibrin and a clot can be formed.
It- trombina mbagħad tibdel il- fibrinoġen f’ fibrin u jista ’ jinħoloq embolu.
The plasma levels of factor VIII are
L- emofilja A hija marda ereditarja fil- koagulazzjoni tad- demm marbuta mas- sess li hija kkawżata minn livelli mnaqqsin fl- attività tal- fattur VIII u tirriżulta f’ emorraġija abbondanti għal ġol- ġogi, il- muskoli jew organi interni, jew b’ mod naturali jew bħala riżultat ta ’ trawma aċċidentali jew kirurġika.
7 increased by replacement therapy, thereby enabling a temporary correction of the factor VIII deficiency and correction of the bleeding tendency.
Il- livelli tal- fattur VIII fil- plażma jiżdiedu bit- terapija ta ’ sostituzzjoni, u b’ hekk jippermettu korrezzjoni temporanja għan- nuqqas tal- fattur u l- korrezzjoni tat- tendenza għal fsada.
All pharmacokinetic studies with ADVATE were conducted in previously treated patients with severe to moderately severe haemophilia A (baseline factor VIII ≤ 2%).
5. 2 Tagħrif farmakokinetiku
The analysis of plasma samples was conducted in a central laboratory using a one-stage clotting assay.
L- analiżi tal- kampjuni tal- plażma tmexxew f’ laboratorju ċentrali permezz ta ’ analiżi tat- tagħqid tad- demm f’ fażi waħda.
The pharmacokinetic parameters derived from a crossover study of ADVATE in 100 previously treated patients ≥ 10 years of age are listed in table 3 below.
Il- parametri farmakokinetiċi li ħarġu minn studju inkroċjat ta ’ ADVATE f’ 100 pazjent li kienu ġew ikkurati qabel f’ età ≥10 snin huma elenkati f’ tabella 3 hawn taħt.
Table 3 Summary of pharmacokinetic parameters for ADVATE in 100 patients with severe to moderately severe haemophilia A (factor VIII ≤ 2%) PK Parameter AUC0-∞ (IU· h/ dl) t1/ 2 (h) Adjusted Recovery
Tabella 3 Ġabra fil- qosor tal- parametri farmakokinetiċi għal ADVATE f’ 100 pazjent b’ emofilja A severa jew moderatament severa (fattur VIII ≤ 2%) Medda Parametru PK
1527* 11.8
Medja 1527 *
(IU/ dl/ IU/ kg) Cmax (IU/ dl) Clearance (dl/ kg· h) MRT (h) VSS (dl/ kg) * Geometric mean
Irkupru Aġġustat (IU/ dl/ IU/ kg)
Data from single-dose administrations of ADVATE in 53 paediatric patients less than 6 years of age were used to obtain this table.
8 Intużat informazzjoni minn amministrazzjonijiet ta 'doża waħda ta' ADVATE fi 53 pazjent pedjatriku ta 'anqas minn 6 snin biex tinkiseb din it- tabella.
Table 4 Summary of pharmacokinetic parameters for ADVATE in 53 paediatric patients with severe to moderately severe haemophilia A
Tabella 4 Parametri farmakokinetiċi fil- qosor għal ADVATE fi 53 pazjent pedjatriku b’ emofilja A severa għal moderatament severa
PK Parameter AUC0-∞ (IU· h/ dl) t1/ 2 (h) Adjusted Recovery
Parametru PK
Mean 1195* 9.7
Medja 1195 *
1.84* 93* 0.044 12.2 0.51
Cmax (IU/ dl) Rata ta ’ eliminazzjoni
Adjusted recovery and terminal half-life (t1/ 2) was approximately 20% lower in young children (less than 6 years of age) than in adults, which may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
L- irkupru aġġustat u l- half- life terminali (t1/ 2) kienu madwar 20% aktar baxxi fi tfal żgħar (ta ’ inqas minn 6 snin) milli fl- adulti, li jista ’ jkun dovut parti għal volum akbar magħruf tal- plażma għal kull kilogramm ta 'piż tal- ġisem f' pazjenti iżgħar.
Pharmacokinetic data with ADVATE on previously untreated patients are currently not available.
Attwalment m' hemmx tagħrif farmakokinetiku disponibbli dwar ADVATE fuq pazjenti li ma kinux ġew ikkurati qabel.
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, acute toxicology, repeated dose toxicity, local toxicity and genotoxicity.
Informazzjoni mhux klinika ma turi l- ebda periklu speċjali għall- bniedem fuq il- bażi ta 'studji ta' sigurtà farmakoloġika, tossikoloġija akuta, tossiċità b' doża ripetuta, tossiċità lokali u ġenotossiċità.
Powder Mannitol Sodium chloride Histidine Trehalose Calcium chloride Trometamol Polysorbate 80 Glutathione (reduced)
Trab Mannitol Sodium chloride Histidine Trehalose Calcium chloride Trometamol Polysorbate 80 Glutathione (ridott).
Solvent Sterilised water for injections
Solvent Ilma sterilizzat għall- injezzjonijiet.
Unopened powder vial 2 years.
6. 2 Inkompatibilitajiet
After reconstitution Chemical and physical in-use stability has been demonstrated for 3 hours at 25°C.
Wara r- rikostituzzjoni L- istabilità kimika u fiżika waqt l- użu ġiet murija għal 3 sigħat f’ temperatura ta ’ 25°C.
From a microbiological point of view, the product should be used immediately after reconstitution.
Minn aspett mikrobijoloġiku, il- prodott għandu jintuża immedjatament wara r- rikostituzzjoni.
During the shelf life, the product may be kept at room temperature (up to 25°C) for a single period not exceeding 2 months.
Fiż- żmien li jdum tajjeb, il- prodott jista 'jinżamm f' temperatura ambjentali (sa 25°C) għal perjodu wieħed li ma jaqbiżx xahrejn.
The beginning of storage at room temperature should be recorded on the product carton.
Il- bidu ta ’ żmien ta ’ ħażna f' temperatura ambjentali għandu jiġi reġistrat fuq il- kartuna tal- prodott.
The product may not be returned to refrigerated storage again.
Il- prodott ma jistax jerġa 'jinħażen fil- friġġ għal darb ’ oħra.
Keep the vial in the outer carton in order to protect from light.
Żomm il- kunjett fil- kartuna biex tilqa 'mid- dawl.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Dwar il- kondizzjonijiet għall- ħażna tal- prodott mediċinali rikostitwit, ara sezzjoni 6. 3.
Each pack contains a powder vial, a vial containing 5 ml solvent (both type I glass closed with chlorobutyl rubber stoppers) and a device for reconstitution (BAXJECT II).
Kull pakkett fih kunjett tat- trab, kunjett li fih 5 ml solvent (it- tnejn magħmulin minn ħġieġ tat- tip I magħluqin b’ tapp tal- lastku chlorobutyl) u strument għar- rikostituzzjoni (BAXJECT II).
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali għar- rimi ta 'prodotti mediċinali u għal immaniġġar ieħor
Advate is to be administered intravenously after reconstitution of the lyophilized product with the provided sterilised water for injections.
ADVATE għandu jiġi amministrat ġol- vina wara rikostituzzjoni tal- prodott lijofilizzat bl- ilma sterilizzat ipprovdut għall- injezzjonijiet.
After reconstitution the solution should be clear, colourless and free from foreign particles.
Wara r- rikostituzzjoni s- soluzzjoni għandha tkun ċara, bla kulur u ħielsa minn partikuli barranin.
- For reconstitution use only the sterilised water for injections and the reconstitution device
- Għar- rikostituzzjoni uża biss l- ilma sterilizzat għall- injezzjonijiet u l- istrument
provided in the pack.
għar- rikostituzzjoni pprovduti fil- pakkett.
For administration the use of a luer-lock syringe is required.
Biex jingħata hija meħtieġa siringa luer- lock.
- Use within three hours after reconstitution.
- Uża fi żmien tliet sigħat wara r- rikostituzzjoni.
- Do not refrigerate the preparation after reconstitution.
- Tpoġġix il- preparazzjoni fil- friġġ wara r- rikostituzzjoni.
- Dispose any unused product or waste material in accordance with local requirements.
- Armi kwalunkwe prodott mhux użat jew skart minn dawn il- prodotti skont ir- regolamenti lokali.
- Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or
- Tużax jekk l- istrument BAXJECT II, is- sistema ta 'barriera sterili tiegħu jew il- pakkett tiegħu
shows any sign of deterioration.
jkunu bil- ħsara jew juru xi sinjal ta 'taħsir
Reconstitution Aseptic Technique should be used
Teknika Asettika għandha tintuża:
If the product is still stored in a refrigerator, take both the ADVATE powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 25°C).
Jekk il- prodott maħżun kien fil- friġġ, ħu kemm l- ADVATE (trab) u l- kunjetti tas- solvent minn ġol- friġġ u ħallihom jilħqu t- temperatura tal- kamra (bejn 15°C u 25°C).
Wash your hands thoroughly using soap and warm water.
Aħsel idejk sew billi tuża s- sapun u l- ilma fietel.
Remove caps from powder and solvent vials.
Neħħi t- tappijiet mill- kunjetti tat- trab u tas- solvent.
Cleanse stoppers with alcohol swabs.
Naddaf it- tappijiet bil- ġbajjar tal- alkoħol.
Place the vials on a flat clean surface.
Qiegħed il- kunjetti fuq wiċċ ċatt u nadif.
Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a).
Iftaħ il- pakkett tal- istrument BAXJECT II billi tqaxxar l- għatu tal- karta mingħajr ma tmiss ġewwa (Fig. a).
Do not remove the device from the package.
Tneħħix l- istrument mill- pakkett.
Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
M’ għandekx tuża jekk it- tagħmir BAXJECT II, is- sistema ta ’ barriera sterili jew il- pakkett ikunu bil- ħsara jew juru sinjali ta ’ taħsir.
Turn the package over and insert the clear plastic spike through the solvent stopper.
Aqleb il- pakkett u daħħal il- ponta iebsa tal- plastik ġot- tapp tas- solvent.
Grip the package at its edge and pull the package off BAXJECT II (Fig. b).
Aqbad il- pakkett mit - tarf tiegħu u iġbed il- pakkett minn fuq BAXJECT II (Fig. b).
Do not remove the blue cap from the BAXJECT II device.
Tneħħix it- tapp il- blu mill - istrument BAXJECT II.
For reconstitution only the water for injections and the reconstitution device provided in the pack should be used.
Għal rikostituzzjoni għandhom jintużaw biss l- ilma għal injezzjonijiet u t- tagħmir ta ’ rikostituzzjoni fil- pakkett biss.
With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device.
B’ BAXJECT II imwaħħal mal- kunjett tas- solvent, aqleb
Insert the white plastic spike through the ADVATE stopper.
Daħħal il- ponta bajda tal- plastik ġot- tapp ta 'ADVATE.
The vacuum will draw the solvent into the ADVATE vial (Fig. c).
Il- vakwu jiġbed is- solvent ġol- kunjett b’ ADVATE (Fig. ċ).
Swirl gently until all material is dissolved.
Dawwar bil- mod sakemm il- materjal kollu jkun inħall.
Be sure that ADVATE is completely dissolved, otherwise not all reconstituted solution will pass through the device filter.
Aċċerta ruħek li ADVATE ikun inħall kompletament, inkella mhux is- sustanza rikostitwita kollha tgħaddi mill- filtru tal- istrument.
The product dissolves rapidly (usually in less than 1 minute).
Il- prodott jinħall malajr (normalment f’ anqas minn minuta).
After reconstitution the solution should be clear, colourless and free from foreign particles.
Wara r- rikostituzzjoni s- soluzzjoni għandha tkun ċara u ħielsa minn partikuli barranin.
Fig. c
Fig. ċ
Administration Use Aseptic Technique
Amministrazzjoni Uża Teknika Asettika
Parenteral medicinal products should be inspected for particulate matter prior to administration, whenever solution and container permit.
Il- prodotti tal- mediċina parenterali għandhom ikunu miflija għal xi frak qabel ma jingħataw, kull meta s- soluzzjoni u l- kontenitur jippermettu.