qanastek/EMEA-V3 huggingface dataset:
Hypersensitivity (allergic reactions) has sometimes been seen in patients treated with factor VIII-containing products.
Sensittività eċċessiva (reazzjonijiet allerġiċi) kultant dehret f’ pazjenti kkurati bi prodotti li fihom il- fattur VIII.
Other side effects seen in rare cases were dysgeusia (taste disturbances), nausea, reactions at the injection site, pyrexia (fever), allergic or anaphylactic (severe allergic) reactions, abnormal blood pressure, dizziness, pruritus (itching) and rash.
Effetti sekondarji oħrajn jistgħu jidhru f’ każijiet rari bħal dysgeusia (disturbi fit- togħma), nawsja, reazzjonijiet fis- sit ta ’ l- injezzjoni, pyrexia (deni), reazzjonijiet allerġiċi jew anaflaktiċi, reazzjonijiet ta ’ (allerġija severa), pressjoni tad- demm mhux normali, ħass ħażin bi sturdament, pruritus (ħakk) u raxx.
KOGENATE Bayer should not be used in people who may be hypersensitive (allergic) to recombinant coagulation factor VIII, to mouse or hamster protein or to any of the other ingredients.
KOGENATE Bayer m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għall- fattur ta ’ koagulazzjoni VIII rikombinanti, għal proteini tal- ġurdien jew tal- ħamster jew għal xi sustanzi oħra.
Why has KOGENATE Bayer been approved?
Għaliex ġie approvat KOGENATE Bayer?
The Committee for Medicinal Products for Human Use (CHMP) decided that KOGENATE Bayer’ s benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Il- Kumitat dwar Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ KOGENATE Bayer huma akbar mir- riskji tiegħu għall- kura u l- prevenzjoni ta ’ fsada f’ pazjenti b’ emofilja A (defiċjenza konġenitali tal- fattur VIII).
The Committee recommended that KOGENATE Bayer be given marketing authorisation.
Il- Kumitat irrikmanda li KOGENATE Bayer jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about KOGENATE Bayer:
Aktar tagħrif dwar KOGENATE Bayer:
The European Commission granted a marketing authorisation valid throughout the European Union for KOGENATE Bayer on 4 August 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal KOGENATE Bayer, fl- 4 ta ’ Awwissu 2000.
The full EPAR for KOGENATE Bayer is available here.
L- EPAR sħiħ għal KOGENATE Bayer jista ’ jinstab hawnhekk.
This summary was last updated in 10-2007.
Dan is- sommarju kien aġġornat l- aħħar f’ 10- 2007.
Powder and solvent for solution for injection-
Trab u solvent għal soluzzjoni għall - injezzjoni
Intravenous use-
Għal użu ġol- vina.
powder: vial (glass); solvent: pre-filled syringe (glass)-
1 fjala (ħġieġ); Solvent:
powder:
1 siringa mimlija (ħġieġ)
2.5 ml (100 IU/ ml)-
250 IU; Ilma għall- injezzjoni 2. 5 ml (100 IU/ ml)
1 vial + 1 pre-filled syringe + 1 Bio-Set device**
1 fjala + 1 siringa mimlija minn qabel + tagħmir tal- Bio- Set **
2.5 ml (200 IU/ ml)-
500 UI; Ilma għall- injezzjoni 2. 5 ml (200 IU/ ml)
2.5 ml (400 IU/ ml)-
1000 IU; Ilma għall- injezzjoni 2. 5 ml (400 IU/ ml)
Powder and solvent for solution for injection-
Trab u solvent għal soluzzjoni għall - injezzjoni -
1 vial 1 pre-filled syringe 1 vial adapter**
1 fjala + 1 siringa mimlija minn qabel + adapter għall- fjala **
2.5 ml (200 IU/ ml)-
500 IU; Ilma għall- injezzjoni 2. 5 ml (200 IU/ ml)
5.0 ml (400 IU/ ml)-
2000 IU; Ilma għall- injezzjoni 5. 0 ml (400 IU/ ml)
1/ 2 * - 1 transfer device
1/ 2 * - tagħmir li jitrasferixxi
- 1 filter needle
- labra bil- filtru
- 1 venipuncture set
- sett għat- titqib tal- vina
- 1 plastic syringe (5 ml)
- siringa tal- plastik (5 ml)
- two sterile alcohol swabs for single use
- żewġ msiħ sterili bl- alkoħol biex jintużaw darba.
** - 1 venipuncture set
** - sett għat- titqib tal- vina
- 2 sterile alcohol swabs for single use
- 2 msiħ sterili bl- alkoħol biex jintużaw darba
- 2 dry swabs
- 2 msiħ xotti
- 2 plasters
- 2 iġbajjar
KOGENATE Bayer 250 IU Powder and solvent for solution for injection.
KOGENATE Bayer 250 IU Trab u solvent għal soluzzjoni għall- injezzjoni
until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% b) By continuous infusion Raise factor VIII activity pre- surgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/ Kg/ h) adjusting according to patient’ s daily clearance and desired factor VIII levels for at least 7 days.
Għolli l- attività ta ’ fattur VIII qabel l- intervent kirurġiku permezz ta ’ bolus infużjonali fil- bidu u minnufih segwi b’ infużjoni kontinwa (f’ IU/ Kg/ h) u aġġusta skond ir- rata ta ’ eliminazzjoni ta ’ kuljum tal - pazjent u l- livelli ta ’ fattur VIII mixtieqa almenu għal 7ijiem
It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that KOGENATE Bayer can be used for continuous infusion in surgeries (pre-, during and postoperative).
Ġie muri fi studju kliniku mwettaq f’ pazjenti adulti b’ emofilija A li jkollhom kirurġija maġġura li KOGENATE Bayer jista ’ jintuża għal infużjonijiet kontinwi f’ interventi kirurġiċi (qabel, waqt u wara l- intervent kirurġiku).
This should be considered for a continuous infusion administration.
KOGENATE Bayer fih livelli baxxi ta ’ polysorbate- 80 bħala sustanza mhux attiva li hu magħruf li jżid ir- rata ta ’ estrazzjoni ta ’ di - (2- ethylhexyl) phthalate (DEHP) minn materjali ta ’ polyvinyl chloride (PVC).
For scheduled prophylaxis against bleeds in patients with severe haemophilia A, doses of 20 to 60 IU of KOGENATE Bayer per kg body weight should be given at intervals of 2 to 3 days.
Għal profilassi skedata, f’ pazjenti li għandhom fsada ta ’ emofilija A severa, id- doża għandha tkun minn 20 sa 60 IU ta ’ KOGENATE Bayer għal kull kg ta 'piż tal- ġisem f' intervalli ta 'jumejn jew kull 3 ijiem.
If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer.
Jekk jinstab li hemm sustanza inibitura li ma taqbiżx 10 Bethesda Units (BU) kull ml, għandu jingħata aktar fattur VIII (fattur VIII rikombinanti tal- koagulazzjoni) biex immewwet l- effett tas- sustanza inibitura u jippermetti li titkompla t- terapija effettiva b' KOGENATE Bayer.
KOGENATE Bayer should be injected intravenously over several minutes.
KOGENATE Bayer għandu jingħata b’ injezzjoni ġol- vina fuq medda ta ’ numru ta ’ minuti.
KOGENATE Bayer can be infused by continuous infusion.
KOGENATE Bayer jista ’ jingħata b’ infużjoni kontinwa.
3 ml/ h/ kg
infużjoni IU/ h/ kg
Desired plasma FVIII level
pazjent ta ’ 75 kg / f’ ml/ h
Infusion rate IU/ h/ kg
Rata ta ’ eliminazzjoni:
Subsequent infusion rates should be calculated based on the actual FVIII levels and recalculated clearance for each day post surgery based on the equation: clearance = infusion rate/ actual FVIII level.
Rati ta ’ infużjonijiet sussegwenti għandom jiġu kkalkulati skond il- livelli ta ’ FVIII reali u għar- rata ta ’ eliminazzjoni kkalkulata mill- ġdid għal kull jum wara l- intervent kirurġiku skond l- ekwazzjoni:
In the interest of the patients, it is recommended that, whenever possible, every time that KOGENATE Bayer is administered to them, the name and the batch number of the product is registered.
Fl- interess tal- pazjenti, huwa rakkomandat li kull meta jkun possibbli, kull darba li KOGENATE Bayer jiġi mogħti lilhom, l- isem u n- numru tal- lott tal- prodott jiġi reġistrat.
No interactions of KOGENATE Bayer with other medicinal products are known.
M’ hemmx prodotti mediċinali magħrufa li ma ’ jaqblux ma KOGENATE Bayer.
Animal reproduction studies have not been conducted with KOGENATE Bayer.
Ma sarux studji fuq ir- riproduzzjoni fl- annimali b 'KOGENATE Bayer.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of KOGENATE Bayer during pregnancy and breast-feeding is not available.
Minħabba każijiet rari ta ’ l- emofilija A fin- nisa, l- esperjenza dwar l- użu ta ’ KOGENATE Bayer fit - tqala u t- treddigħ m' hiex disponibbli.
Therefore, KOGENATE Bayer should be used during pregnancy and lactation only if clearly indicated.
Għaldaqstant, KOGENATE Bayer għandu jintuża fit- tqala u t - treddigħ meta jkun hemm biss indikazzjoni ċara.
KOGENATE Bayer has no influence on the ability to drive or to use machines.
KOGENATE Bayer m’ għandux influenza fuq il- ħila biex issuq u tħaddem magni.
After administration of KOGENATE Bayer mild to moderate adverse events were observed in rare cases as presented in the following table.
Effetti avversi ħfief jew ta ’ qawwa moderata, wara l- għoti ta 'KOGENATE Bayer, ġew osservati f ’ każijiet rari kif preżentati fit- tabella li ġejja.
5 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Sistema tal- klassifika ta ’ l- organi fid- database MedDRA
The formation of neutralising antibodies to factor VIII
Il- formazzjoni ta ’ anti- korpi li jinnewtralizzaw kontra komplikazzjoni magħrufa waqt fil- ġestjoni ta ’ individwi
(inhibitors) is a known complication in the
l- fattur VIII (sustanzi inibituri) hija bl- emofilija A.
In clinical studies, KOGENATE Bayer has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated pediatric patients (MTPs, defined as having equal to or less than 4 exposure days).
Fi studji kliniċi, KOGENATE Bayer intuża fit- trattamenti ta ’ episodji emorraġiċi f’ 37 pazjent li ma kienux trattati qabel (PUPs) u f' 23 pazjent pedjatriku minimamemt ittrattati (MTPs, imfisser bħala li kellhom espożizzjoni ugwali għal jew inqas minn 4 ijiem).
Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with KOGENATE Bayer developed inhibitors:
Ħamsa minn 37 (14%) pazjent PUP u 4 minn 23 (17%) pazjent MTP ittrattati b’ KOGENATE Bayer żviluppaw inibituri:
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
6 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
The factor VIII/ von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions.
Il- kumpless tal- fattur VIII/ fattur von Willebrand (vWF) huwa magħmul minn żewġ molekuli (fattur VIII u vWF) li għandhom funzjonijiet fiżjoloġiċi differenti.
Activated factor VIII acts as a cofactor for activated factor
Meta jingħata b' infużjoni f 'pazjent bl - emofilja il- fattur VIII jeħel ma ’ vWF fis- sistema taċ- ċirkolazzjoni tal- pazjent.
6 IX, accelerating the conversion of factor X to activated factor X.
Meta l- fattur VIII jkun attivat, huwa jaħdem bħala ko- fattur fuq il- fattur IX attivat, biex b ’ hekk iżid ir- rata ta 'bidla tal- fattur X għal fattur X attivat.
The degree and duration of aPTT normalisation observed after administration of KOGENATE Bayer is similar to that achieved with plasma-derived factor VIII.
Il- grad u ż- żmien osservat tan- normalizzazzjoni ta’ l- aPTT wara l- għoti ta 'KOGENATE Bayer huwa bħal dak miksub meta jingħata fattur VIII li jkun ġie mill - plażma.
The analysis of all recorded in vivo recoveries in previously treated patients demonstrated a mean rise of 2% per IU/ kg body weight for KOGENATE Bayer.
L- analiżi miksuba minn fuq pazjenti li rkupraw in vivo wara l- kura minn qabel uriet medja ta ’ żjieda ta ’ 2% kull IU/ kg piż tal- ġisem għal KOGENATE Bayer.
After administration of KOGENATE Bayer, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours.
Wara l- għoti ta 'KOGENATE Bayer, l- ogħla attività tal- fattur VIII tonqos b ’ mod esponenzjali f’ żewġ fażijiet ta' degradazzjoni bil- medja tal- half- life terminali tkun ta ’ madwar 15- il siegħa.
Additional pharmacokinetic parameters for KOGENATE Bayer for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/ h.
Aktar parametri farmakokinetiċi ta 'KOGENATE Bayer għal bolus injection huma: żmien medju residenzjali [MRT (0- 48)] ta ’ madwar 22 siegħa, u rata ta ’ eliminazzjoni ta ’ madwar 160 ml/ h.
Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/ h corresponding to 3.0 ml/ h/ kg (range 1.6-4.6 ml/ h/ kg).
Ir- rata ta ’ eliminazzjoni medja ta ’ riferiment għal 14- il pazjent adult li jkollhom interventi kirurġiċi maġġuri b’ infużjoni kontinwa hija ta ’ 188 ml/ siegħa li jikkorispondi għal 3. 0 ml/ h/ kg (firxa fuq 1. 6- 4. 6 ml/ h/ kg).
Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for KOGENATE Bayer in laboratory animals (mouse, rat, rabbit, and dog).
Studji fuq annimali tal- laboratorju (ġurdien, far, fenek, u kelb) b' KOGENATE Bayer urew li dożi li huma ogħla mid- doża klinika rakkomandata (meta mqabbel mal- piż tal- ġisem) naqsu milli jistabilixxu xi sinjali ta 'tossiċità akuta jew subakuta.
No studies were performed on the mutagenic potential of KOGENATE Bayer, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of KOGENATE Bayer.
Ma sarux studji fuq il- possibiltà ta ’ effetti mutaġeniċi minn KOGENATE Bayer billi fuq prodott li ħareġ qabel KOGENATE Bayer ma kien hemm ebda effett mutaġeniku potenzjali kemm in vitro kif ukoll in vivo.
Each package of KOGENATE Bayer contains: • one vial with powder (10 ml clear glass type 1 vial with latex-free grey bromobutyl rubber blend stopper and aluminium seal) • one vial with solvent (10 ml clear glass type 2 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal) • an additional package with:
Kull pakkett ta ’ KOGENATE Bayer fih: • kunjett bit- trab (10 ml, ħġieġ trasparenti tip 1 kunjett magħluqa b’ għatu griż ta 'mmarkat li ma fihx latex u ssiġillat bl- aluminju). • kunjett wieħed bis- solvent (10 ml, ħġieġ trasparenti tip 2 kunjett magħluq b’ għatu griż ta' chlorobutyl rubber blend, li ma fihx latex, u ssiġillat bl- aluminju). • pakkett ieħor li fih:
- 1 transfer device
- tagħmir 1 biex jitrasferixxi
- 1 filter needle
- labra 1 bil- filtru
- 1 plastic syringe (5 ml)
- siringa 1 tal- plastik (5 ml)
Detailed instructions for preparation and administration are contained in the package leaflet provided with KOGENATE Bayer.
Struzzjonijiet dettaljati ta 'kif jiġi ppreparat u jingħata jinstabu fil- fuljett ta ’ tagħrif fil- pakett ta' KOGENATE Bayer.
KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) using the supplied sterile transfer device.
KOGENATE Bayer għandu jiġi rikostitwit biss bis- solvent provdut (2, 5 ml ilma għall- injezzjoni) permezz tat- tagħmir li jitrasferixxi, li huwa provdut.
Gently rotate the vial until all powder is dissolved.
Dawwar bil- mod il - kunjett sakemm iddewweb it- trab.
Do not use KOGENATE Bayer if you notice visible particulate matter or turbidity.
Tużax KOGENATE Bayer jekk tara xi frak jew is- soluzzjoni tiġi mdardra.
After reconstitution, the solution is drawn through the sterile filter needle into the sterile disposable syringe (both supplied).
Wara li tirrikosstitwixxi l- prodott, għaddi s- soluzzjoni minn ġol- filtru sterili tal- labra għal ġos- siringa sterili li tntuża darba biss (provduti t- tnejn).
KOGENATE Bayer 500 IU Powder and solvent for solution for injection.
KOGENATE Bayer 500 IU Trab u solvent għal soluzzjoni għall- injezzjoni
13 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Sistema tal- klassifika ta ’ l- organi fid- database MedDRA
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
14 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
14 IX, accelerating the conversion of factor X to activated factor X.
Meta l- fattur VIII jkun attivat, huwa jaħdem bħala ko- fattur fuq il- fattur IX attivat, biex b ’ hekk iżid ir- rata ta 'bidla tal- fattur X għal fattur X attivat.
KOGENATE Bayer 1000 IU Powder and solvent for solution for injection.
KOGENATE Bayer 1000 IU Trab u solvent għal soluzzjoni għall- injezzjoni
21 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Sistema tal- klassifika ta ’ l- organi fid- database MedDRA
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
22 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
22 IX, accelerating the conversion of factor X to activated factor X.
Meta l- fattur VIII jkun attivat, huwa jaħdem bħala ko- fattur fuq il- fattur IX attivat, biex b ’ hekk iżid ir- rata ta 'bidla tal- fattur X għal fattur X attivat.
The solvent is water for injections provided in a pre-filled syringe.
Is- solvent huwa ilma għall- injezzjonijiet fornut f' siringa mimlija lesta.
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Għal kura u l- profilassi tal- fsada f 'pazjenti li għandhom emofilja A (nuqqas konġenitali tal- fattur VIII).
Posology The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products.
Pożoloġija L- għadd ta 'unitajiet tal- fattur VIII li jingħata huwa mkejjel b’ Unitajiet Internazzjonali (IU), li huma relatati ma ’ l- istandard attwali tal- WHO dwar prodotti tal- fattur VIII.
until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% b) By continuous infusion Raise factor VIII activity pre- surgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/ Kg/ h) adjusting according to patient’ s daily clearance and desired factor VIII levels for at least 7 days.
Għolli l- attività ta ’ fattur VIII qabel l- intervent kirurġiku permezz ta ’ bolus infużjonali fil- bidu u minnufih segwi b’ infużjoni kontinwa (f’ IU/ Kg/ h) u aġġusta skond ir- rata ta ’ eliminazzjoni ta ’ kuljum tal - pazjent u l- livelli ta ’ fattur VIII mixtieqa almenu għal 7 ijiem
In patients with inhibitor titres above 10 BU or with high anamnestic response, the use of (activated) prothrombin complex concentrate (PCC) or recombinant activated factor VII (rFVIIa) preparations has to be considered.
L- użu tal- kumpless konċentrat ta ’ prothrombin (attivat) (PCC), jew ta ’ preparazzjonijiet ta ’ fattur VIII attivat ta ’ oriġini rikombinanti (rFVIIa) ġew ikkunsidrati f’ pazjenti li jkollhom livelli ta ’ sustanza inibitura akbar minn 10 BU, jew anamnestic response għoli.
Administration Reconstitute the preparation as described in section 6.6.
Kif jingħata Irrikostitwixxi l- preparazzjoni skond kif indikat f ’ sezzjoni 6. 6.
The rate of administration should be determined by the patient’ s comfort level (maximal rate of injection:
Ir- rata ta ’ amministrazzjoni għandha tiġi stabbilita skond kif iħossu l- pazjent (l- ogħla rata ta ’ l- injezzjoni:
If allergic or anaphylactic reactions occur, the injection/ infusion should be stopped immediately and the patient should contact their physician.
Jekk isseħħu reazzjonijiet allerġiċi jew anafilattiċi, waqqaf l - injezzjoni/ infużjoni mill- ewwel, u l- pazjenti għandhom jikkuntattjaw lit- tabib tagħhom.
No interactions of KOGENATE Bayer with other medicinal products are known.
M’ hemmx prodotti mediċinali magħrufa li ma jaqblux ma ’ KOGENATE Bayer.
Animal reproduction studies have not been conducted with KOGENATE Bayer.
Ma ’ sarux studji fuq ir- riproduzzjoni fl- annimali b 'KOGENATE Bayer.
KOGENATE Bayer has no influence on the ability to drive or to use machines.
KOGENATE Bayer m’ għandux influenza fuq il- ħila biex issuq u tħaddem magni m’ għandux.
29 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Sistema tal- klassifika ta ’ l- organi fid- database MedDRA
In studies with recombinant factor VIII preparations, development of inhibitors is predominantly observed in previously untreated haemophiliacs.
Fi studji b’ sustanzi li fihom il - fattur VIII rikombinanti intwera li sustanzi inibituri żviluppaw l- aktar f’ pazjenti li qatt qabel ma kienu ġew ikkurati għall- emofilja.
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
30 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
However, the possibility of allergic reactions to constituents, e. g. trace amounts of mouse and hamster protein in the preparation exists in certain predisposed patients (see section 4.3 and 4.4).
Madankollu, xorta hemm possibbiltà ta ’ reazzjonijiet allerġiċi għas- sustanzi, eż: ammonti żgħar ħafna ta ’ proteina tal- ġurdien jew ħamster preżenti fil- preparazzjoni f 'ċerti pazjenti sensittivi (ara 4. 3 u 4. 4).
When infused into a haemophiliac patient, factor VIII
Il- kumpless tal- fattur VIII/ fattur von Willebrand (vWF) huwa magħmul minn żewġ molekuli (fattur VIII u vWF) li għandhom funzjonijiet fiżjoloġiċi differenti.
30 binds to vWF in the patient’ s circulation.
Meta jingħata b' infużjoni f 'pazjent bl - emofilja il- fattur VIII jeħel ma ’ vWF fis- sistema taċ- ċirkolazzjoni tal- pazjent.
Activated factor X converts prothrombin into thrombin.
Meta fattur X jkun attivat, huwa jbiddel prothrombin għal thrombin.
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.
Il- livell fil- plażma tal- fattur VIII jista ’ jiġi mgħolli permezz ta ’ terapija li tagħmel tajjeb għal dan in- nuqqas, u temporanjament tnaqqas it- tendenza tal- pazjent għall- fsada
Determination of activated partial thromboplastin time (aPTT) is a conventional in vitro assay method for biological activity of factor VIII.
Metodu konvenzjonali ta 'assaġġ in vitro li jkejjel l- attività bijoloġika tal- fattur VIII, huwa billi jiġi stabbilit dak il- ħin ta' thromboplastin parzjali attivat (aPTT).
Specific studies with repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with octocog alfa due to the immune response to heterologous proteins in all non-human mammalian species.
Minħabba raġunijiet ta ’ reazzjoni immunitarja għal proteini eterologi minn speċijiiet mammiferi li m' humiex tal- bniedem, ma saru l- ebda studji speċifiċi fejn octocog alfa ngħata b mod ripetut, bħal studju fuq it- tossiċità riproduttiva, tossiċità kronika, u karċinoġeniċità.
Only the provided components (powder vial with Bio-Set device, pre-filled syringe containing solvent and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Biex jingħata, għandhom jintużaw biss il- komponenti provduti (fjala tat- trab mat- tagħmir tal- Bio- Set, siringa mimlija lesta u sett ta ’ titqib) għandhom jintużaw għar- rikostituzzjoni u injezzjoni billi l- kurat tista 'tfalli minħabba li l- fattur VIII tal- koagulazzjoni tal- bniedem jista' jiġi assorbit fuq l- uċuħ interni ta ’ ċertu tagħmir ta 'l- infużjoni.
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.
Żomm il- kunjetti u s- siringa mimlija lesta fil- kaxxa ta 'barra sabiex tilqa' mid- dawl.
In this case, the product expires at the end of this 3-month period; the new expiry date must be noted on the outer carton.
F’ dan il- każ il- prodott jiskadi fl- aħħar ta ’ dan il- perjodu ta ’ - 3 xhur; id- data l- ġdida ta ’ l- iskadenza għandha tiġi mmarkata fil- kartuna ta ’ barra.
6.5 Nature and contents of container
Kull pakkett ta ’ KOGENATE Bayer fih:
Each package of KOGENATE Bayer contains: • one vial plus Bio-Set device, containing powder (10 ml clear glass type 1 vial with latex-free grey bromobutyl rubber blend stopper plus transfer device with protective cap [Bio-Set]) • one pre-filled syringe with 2.5 ml solvent (clear glass cylinder type 2 with latex-free grey bromobutyl rubber blend stopper) • syringe plunger rod • one venipuncture set • two sterile alcohol swabs for single use • two dry swabs • two plasters
magħluqa b’ għatu griż tal- gomma tal- bromobutajl li ma fihx latex, flimkien ma 'tagħmir li jitrasferixxi bl- għatu protettiv [Bio- Set]).
6.6 Special precautions for disposal and other handling
- żewġ msiħ sterili bl- alkoħol biex jintużaw darba
Detailed instructions for preparation and administration are contained in the package leaflet provided with KOGENATE Bayer.
Struzzjonijiet dettaljati ta 'kif jiġi ppreparat u jingħata jinstabu fil- fuljett ta ’ tagħrif fil- pakett ta ’ KOGENATE Bayer.
KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) in the prefilled syringe and the integrated transfer device (Bio-Set).
KOGENATE Bayer għandu jiġi rikostitwit biss bis- solvent provdut (2, 5 ml ilma għall- injezzjonijiet) fis- siringa mimlija lesta u t- tagħmir li jitrasferixxi integrat (Bio- Set).
Gently rotate the vial until all powder is dissolved.
Dawwar bil- mod il- kunjett sakemm it- trab kollu jiġi maħlul.
Do not use KOGENATE Bayer if you notice visible particulate matter or turbidity.
Tużax KOGENATE Bayer jekk tinduna li hemm il- frak preżenti jew is- soluzzjoni hija mdardra.
After reconstitution, the solution is drawn back into the syringe.
Wara li tirrikostitwixxi, s- soluzzjoni għandha tiġi miġbuda lura fis- siringa.
Use the provided venipuncture set for intravenous injection.
Uża s- sett provdut biex ittaqqab għall- injezzjoni ġol- vina.
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ -
During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions.
35 Huwa rakkomandat li l- livell tal- fattur VIII jiġi stabbilit sew matul it- trattament biex ikun hemm gwida dwar id- doża u l- frekwenza ta ’ l- infużjoni li trid tiġi mogħtija.
35 their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Pazjenti individwali jistgħu jvarjaw fir- rispons tagħhom għal fattur VIII, billi jilħqu livelli differenti fl- irkupru in vivo u fid- differenza tal- half- lives.
36 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
4.5 Interactions with other medicinal products and other forms of interaction
37 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
37 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Sistema tal- klassifika ta ’ l- organi fid- database MedDRA
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
38 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
38 binds to vWF in the patient’ s circulation.
Meta jingħata b' infużjoni f 'pazjent bl - emofilja il- fattur VIII jeħel ma ’ vWF fis- sistema taċ- ċirkolazzjoni tal- pazjent.
5.3 Preclinical safety data
39 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
39 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions.
43 Huwa rakkomandat li l- livell tal- fattur VIII jiġi stabbilit sew matul it- trattament biex ikun hemm gwida dwar id- doża u l- frekwenza ta ’ l- infużjoni li trid tiġi mogħtija.
43 their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Pazjenti individwali jistgħu jvarjaw fir- rispons tagħhom għal fattur VIII, billi jilħqu livelli differenti fl- irkupru in vivo u fid- differenza tal- half- lives.
44 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
4.5 Interactions with other medicinal products and other forms of interaction
45 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
45 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Sistema tal- klassifika ta ’ l- organi fid- database MedDRA
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
46 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
46 binds to vWF in the patient’ s circulation.
Meta jingħata b' infużjoni f 'pazjent bl - emofilja il- fattur VIII jeħel ma ’ vWF fis- sistema taċ- ċirkolazzjoni tal- pazjent.
5.3 Preclinical safety data
47 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
47 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
KOGENATE Bayer 2000 IU Powder and solvent for solution for injection.
KOGENATE Bayer 2000 IU Trab u solvent għal soluzzjoni għall- injezzjoni
During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions.
51 Huwa rakkomandat li l- livell tal- fattur VIII jiġi stabbilit sew matul it- trattament biex ikun hemm gwida dwar id- doża u l- frekwenza ta ’ l- infużjoni li trid tiġi mogħtija.
51 their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Pazjenti individwali jistgħu jvarjaw fir- rispons tagħhom għal fattur VIII, billi jilħqu livelli differenti fl- irkupru in vivo u fid- differenza tal- half- lives.
4.5 Interactions with other medicinal products and other forms of interaction
53 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
53 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Sistema tal- klassifika ta ’ l- organi fid- database MedDRA
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
54 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
54 binds to vWF in the patient’ s circulation.
Meta jingħata b' infużjoni f 'pazjent bl - emofilja il- fattur VIII jeħel ma ’ vWF fis- sistema taċ- ċirkolazzjoni tal- pazjent.
5.3 Preclinical safety data
55 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
55 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Each package of KOGENATE Bayer contains: • one vial plus Bio-Set device, containing powder (10 ml clear glass type 1 vial with latex-free grey bromobutyl rubber blend stopper plus transfer device with protective cap [Bio-Set]) • one pre-filled syringe with 5.0 ml solvent (clear glass cylinder type 2 with latex-free grey bromobutyl rubber blend stopper) • syringe plunger rod • one venipuncture set • two sterile alcohol swabs for single use • two dry swabs • two plasters
- kunjett waħda flimkien mat- tagħmir Bio- Set li fih it- trab (10 ml, ħġieġ trasparenti tip1 kunjett
KOGENATE Bayer powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) in the prefilled syringe and the integrated transfer device (Bio-Set).
KOGENATE Bayer għandu jiġi rikostitwit biss bis- solvent provdut (5, 0 ml ilma għall- injezzjonijiet) fis- siringa mimlija lesta u t- tagħmir li jitrasferixxi integrat (Bio- Set).
Recombinant Coagulation factor VIII, 250 IU/ vial.
Fattur VIII tal- koagulazzjoni rikombinanti, 250 IU/ kunjett.
During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions.
59 Huwa rakkomandat li l- livell tal- fattur VIII jiġi stabbilit sew matul it- trattament biex ikun hemm gwida dwar id- doża u l- frekwenza ta ’ l- infużjoni li trid tiġi mogħtija.
59 their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Pazjenti individwali jistgħu jvarjaw fir- rispons tagħhom għal fattur VIII, billi jilħqu livelli differenti fl- irkupru in vivo u fid- differenza tal- half- lives.
2.25 1.125 0.56 1.35 0.68 0.34 0.9 0.45 0.225
0. 56 0. 34 0. 225
60 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
If allergic or anaphylactic reactions occur, the injection/ infusion should be stopped immediately and patient should contact their physician.
Jekk isseħħu reazzjonijiet allerġiċi jew anafilattiċi, waqqaf l - injezzjoni/ infużjoni mill- ewwel, u l- pazjenti għandhom jikkuntattjaw lit- tabib tagħhom.
4.5 Interactions with other medicinal products and other forms of interaction
61 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
61 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Sistema tal- klassifika ta ’ l- organi fid- database MedDRA
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
62 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
62 binds to vWF in the patient’ s circulation.
Meta jingħata b' infużjoni f 'pazjent bl - emofilja il- fattur VIII jeħel ma ’ vWF fis- sistema taċ- ċirkolazzjoni tal- pazjent.
5.3 Preclinical safety data
63 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
63 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
This medicinal product must not be mixed with other medicinal products or solvents.
Dal- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra jew ma 'solventi.
Only the provided components (powder vial, pre-filled syringe containing solvent, vial adapter and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Biex jingħata, għandhom jintużaw biss il- komponenti provduti (fjala tat- trab siringa mimlija lesta u sett ta ’ titqib) għandhom jintużaw għar- rikostituzzjoni u injezzjoni billi l- kura tista 'tfalli minħabba li l- Fattur VIII tal- koagulazzjoni tal- bniedem jista' jiġi assorbit fuq l- uċuħ interni ta ’ ċertu tagħmir ta 'l - infużjoni.
However, chemical and physical in-use stability has been demonstrated for 48 hours at 30°C.
Madankollu, l- istabilità kimika u fiżika waqt l- użu ġiet murija għal 48 siegħa f’ temperatura ta ’ 30°C.
In this case, the product expires at the end of this 3-month period; the new expiry date must be noted on the outer carton.
F’ dan il- każ il- prodott jiskadi fl- aħħar ta ’ dan il- perjodu ta ’ 3 xhur; id- data l- ġdida ta ’ l- iskadenza għandha tiġi mmarkata fil- kartuna ta ’ barra.
Each package of KOGENATE Bayer contains: • one vial with powder (10 ml clear glass type 1 vial with latex-free grey bromobutyl rubber blend stopper and aluminium seal) • one pre-filled syringe with 2.5 ml solvent (clear glass cylinder type 2 with latex-free grey bromobutyl rubber blend stopper) • syringe plunger rod • vial adapter • one venipuncture set • two sterile alcohol swabs for single use • two dry swabs • two plasters
- kunjett waħda bit- trab (10 ml tat- tip 1 tal- ħġieġ ċar b’ għant griż tal- gomma tal- bromobutyl li ma
6.6 Special precautions for disposal and other handling
- żewġ msiħ sterili bl- alkoħol li jintużaw darba
KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) in the prefilled syringe and the vial adapter.
KOGENATE Bayer għandu jiġi rikostitwit biss bis- solvent provdut (2, 5 ml ilma għall- injezzjonijiet) fis- siringa mimlija lesta u l- adapter għall- fjala.
Gently rotate the vial until all powder is dissolved.
Dawwar bil- mod il - kunjett sakemm it- trab kollu jiġi maħlul.
Recombinant Coagulation factor VIII, 500 IU/ vial.
Fattur VIII tal- koagulazzjoni rikombinanti, 500 IU/ kunjett.
During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions.
67 Huwa rakkomandat li l- livell tal- fattur VIII jiġi stabbilit sew matul it- trattament biex ikun hemm gwida dwar id- doża u l- frekwenza ta ’ l- infużjoni li trid tiġi mogħtija.
67 their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Pazjenti individwali jistgħu jvarjaw fir- rispons tagħhom għal fattur VIII, billi jilħqu livelli differenti fl- irkupru in vivo u fid- differenza tal- half- lives.
68 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
4.5 Interactions with other medicinal products and other forms of interaction
69 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
69 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Sistema tal- klassifika ta ’ l- organi fid- database MedDRA
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
70 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
70 binds to vWF in the patient’ s circulation.
Meta jingħata b' infużjoni f 'pazjent bl - emofilja il- fattur VIII jeħel ma ’ vWF fis- sistema taċ- ċirkolazzjoni tal- pazjent.
5.3 Preclinical safety data
71 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
71 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Recombinant Coagulation factor VIII, 1000 IU/ vial.
Fattur VIII tal- koagulazzjoni rikombinanti, 1000 IU/ kunjett.
During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions.
75 Huwa rakkomandat li l- livell tal- fattur VIII jiġi stabbilit sew matul it- trattament biex ikun hemm gwida dwar id- doża u l- frekwenza ta ’ l- infużjoni li trid tiġi mogħtija.
75 their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Pazjenti individwali jistgħu jvarjaw fir- rispons tagħhom għal fattur VIII, billi jilħqu livelli differenti fl- irkupru in vivo u fid- differenza tal- half- lives.
76 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
4.5 Interactions with other medicinal products and other forms of interaction
77 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
77 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Sistema tal- klassifika ta ’ l- organi fid- database MedDRA
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
78 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
78 binds to vWF in the patient’ s circulation.
Meta jingħata b' infużjoni f 'pazjent bl - emofilja il- fattur VIII jeħel ma ’ vWF fis- sistema taċ- ċirkolazzjoni tal- pazjent.
5.3 Preclinical safety data
79 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
79 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Recombinant Coagulation factor VIII, 2000 IU/ vial.
Fattur VIII tal- koagulazzjoni rikombinanti, 2000 IU/ kunjett.
During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions.
83 Huwa rakkomandat li l- livell tal- fattur VIII jiġi stabbilit sew matul it- trattament biex ikun hemm gwida dwar id- doża u l- frekwenza ta ’ l- infużjoni li trid tiġi mogħtija.
83 their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Pazjenti individwali jistgħu jvarjaw fir- rispons tagħhom għal fattur VIII, billi jilħqu livelli differenti fl- irkupru in vivo u fid- differenza tal- half- lives.
84 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
4.5 Interactions with other medicinal products and other forms of interaction
85 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
85 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Sistema tal- klassifika ta ’ l- organi fid- database MedDRA
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
86 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
86 binds to vWF in the patient’ s circulation.
Meta jingħata b' infużjoni f 'pazjent bl - emofilja il- fattur VIII jeħel ma ’ vWF fis- sistema taċ- ċirkolazzjoni tal- pazjent.
5.3 Preclinical safety data
87 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
87 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Each package of KOGENATE Bayer contains: • one vial with powder (10 ml clear glass type 1 vial with latex-free grey bromobutyl rubber blend stopper and aluminium seal) • one pre-filled syringe with 5.0 ml solvent (clear glass cylinder type 2 with latex-free grey bromobutyl rubber blend stopper) • syringe plunger rod • vial adapter • one venipuncture set • two sterile alcohol swabs for single use • two dry swabs • two plasters
- kunjett waħda bit- trab (10 ml tat- tip 1 tal- ħġieġ ċar b’ għant griż tal- gomma tal- bromobutyl li ma
KOGENATE Bayer powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) in the prefilled syringe and the vial adapter.
KOGENATE Bayer għandu jiġi rikostitwit biss bis- solvent provdut (5, 0 ml ilma għall- injezzjonijiet) fis- siringa mimlija lesta u l- adapter għall- fjala.
89 ANNEX II
89 ANNESS II
90 A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA( I) BIJOLOĠIKA ATTIVA U D- DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
91 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.
91 Barraminhekk, RMP aġġornat għandu jiġi sottomess: • Meta informazzjoni ġdida tasal li tista ’ tagħmel impatt fuq l- Ispeċifikazzjoni dwar is- Sigurtà attwali, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet li jimminimizzaw ir- riskju; • Fi żmien 60 jum li jintlaħaq tragward importanti (farmakoviġilanza jew minimizzazzjoni ta ’ riskju). • Fuq talba ta ’ l- EMEA.
92 ANNEX III
92 ANNESS III
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
94 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
KOGENATE Bayer 250 IU Powder and solvent for solution for injection
KOGENATE Bayer 250 IU Trab u solvent għal soluzzjoni għall- injezzjoni
KOGENATE Bayer 250 IU Powder for solution for injection
KOGENATE Bayer 250 IU Trab għal soluzzjoni għall- injezzjoni
97 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
97 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
For reconstitution of KOGENATE Bayer, see package leaflet.
Għar- rikostituzzjoni ta 'KOGENATE Bayer, ara l- fuljett ta' tagħrif.
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
98 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
KOGENATE Bayer 500 IU Powder and solvent for solution for injection
KOGENATE Bayer 500 IU Trab u solvent għal soluzzjoni għall- injezzjoni
KOGENATE Bayer 500 IU Powder for solution for injection
KOGENATE Bayer 500 IU Trab għal soluzzjoni għall- injezzjoni
101 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
101 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
102 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
102 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
KOGENATE Bayer 1000 IU Powder and solvent for solution for injection
KOGENATE Bayer 1000 IU Trab u solvent għal soluzzjoni għall- injezzjoni
104 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
104 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
KOGENATE Bayer 1000 IU Powder for solution for injection
KOGENATE Bayer 1000 IU Trab għal soluzzjoni għall- injezzjoni
105 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
105 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
106 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
1 vial with Bio-Set device with powder for solution for injection.
Kunjett 1 flimkien mat- tagħmir Bio- Set li fih it- trab għal soluzzjoni għal injezzjoni.
1 venipuncture set 2 sterile alcohol swabs for single use 2 dry swabs 2 plasters
Siringa 1 mimlija minn qabel b ’ 2, 5 ml ilma għall- injezzjonijiet bil- planġer tas- siringa separat Sett biex ittaqab il- vina 2 msiħ sterili bl- alkoħol biex jintużaw darba 2 msiħ xotti 2 iġbajjar
The product when kept in its outer carton may be stored at ambient room temperature (< 25°C) for a single period of up to 3 months; note the new expiry date on the carton.
Il- prodott meta miżmum fil- pakkett ta ’ barra jista ’ jiġi maħżun fit- temperatura tal- kamra (< 25oC) għal perjodu wieħed li jdum sa 3 xhur; Innota d- data l- ġdida ta ’ l- iskadenza fuq il- kartuna.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TA ID- DETENTUR L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Read package leaflet before use.
Aqra l- fuljett ta 'tagħrif qabel ma tuża.
109 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
109 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
1 vial with Bio-Set device:
Kunjett 1 bit- tagħmir tal- Bio- Set:
110 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
110 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PRE-FILLED SYRINGE WITH 2.5 ML WATER FOR INJECTIONS
SIRINGA MIMLIJA LESTA B '2, 5 ML ILMA GĦALL- INJEZZJONI
111 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
111 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
114 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
114 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
115 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
115 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
116 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
116 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
119 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
119 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
120 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
120 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
121 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
121 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
KOGENATE Bayer 2000 IU Powder and solvent for solution for injection
KOGENATE Bayer 2000 IU Trab u solvent għal soluzzjoni għall- injezzjoni
1 venipuncture set 2 sterile alcohol swabs for single use 2 dry swabs 2 plasters
Siringa 1 mimlija minn qabel b ’ 5, 0 ml ilma għall- injezzjonijiet bil- planġer tas- siringa separat Sett biex ittaqab il- vina 2 msiħ sterili bl- alkoħol biex jintużaw darba 2 msiħ xotti 2 iġbajjar
124 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
124 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
KOGENATE Bayer 2000 IU Powder for solution for injection
KOGENATE Bayer 2000 IU Trab għal soluzzjoni għall- injezzjoni