qanastek/EMEA-V3 huggingface dataset:
3 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.
It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that Helixate NexGen 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 Helixate NexGen jista ’ jintuża għal infużjonijiet kontinwi f’ interventi kirurġiċi (qabel, waqt u wara l - intervent kirurġiku).
In this study heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions.
F’ dan l- istudju l- eparina ġiet użata biex tipprevjeni t- tromboflebite fis- sit ta ’ l - infużjoni bħal fil- każ ta ’ infużjonijiet intravenużi oħra fuq perijodu ta ’ żmien twil.
For the calculation of the initial infusion rate, clearance can be obtained by performing a pre-surgery decay curve, or by starting from an average population value (3.0-3.5 ml/ h/ Kg) and then adjust accordingly.
Għall- kalkulazzjoni tar- rata ta ’ infużjoni totali, ir- rata ta ’ eliminazzjoni, tista ’ tinkiseb billi ssir decay curve ta ’ qabel il - kirurġija jew billi jinbeda minn valur ta ’ popolazzjoni medja (3. 0- 3. 5ml/ h/ Kg) u mbagħad issir l - aġġustament skond dan.
Infusion rate (in IU/ Kg/ h) = Clearance (in ml/ h/ Kg) x desired factor VIII level (in IU/ ml) For continuous infusion, clinical and in vitro stability has been demonstrated using ambulatory pumps with a PVC reservoir.
Rata ta ’ infużjoni (f’ IU/ Kg/ h) = Rata ta ’ eliminazzjoni (f’ ml/ h/ Kg) x il- livell ta ’ fattur VIII mixtieq (f’ IU/ ml) Għal stabbilità ta ’ infużjoni kontinwa, klinika u in vitro ġiet murija permezz ta ’ pompi ambulatorji b’ riżervwar tal- PVC.
This should be considered for a continuous infusion administration.
Helixate NexGen 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 Helixate NexGen 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 ’ Helixate NexGen għal kull kg ta 'piż tal- ġisem f' intervalli ta 'jumejn jew kull 3 ijiem.
In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
F’ ċerti każi, speċjalment f’ pazjenti żgħar, jaf ikun meħtieġ li d- dożi jingħataw aktar ta 'spiss jew dożi jkunu aktar għoljin.
Data have been obtained in 61 children under 6 years of age.
Informazzjoni ġiet miksuba minn fuq 61 tifel u tifla taħt is- 6 snin.
Patients with inhibitors
Pazjenti li jkollhom sustanzi inibituri
Patients should be monitored for the development of factor VIII inhibitors.
Il- pazjenti għandhom jiġu ssorveljati minħabba l- iżvilupp ta 'sustanzi inibituri tal- fattur VIII.
If the expected plasma factor VIII 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 l - attività tal- fattur VIII fil- plażma m' hiex milħuqa, jew il- fsada ma tiġiex ikkontrollata b’ doża xierqa, assaġġ għandu jiġi mwettaq sabiex jistabilixxi jekk sustanzi inibituri tal- fattur VIII humiex preżenti.
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 Helixate NexGen.
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' Helixate NexGen.
However, in the presence of an inhibitor the doses required are variable and must be adjusted according to clinical response and monitoring of plasma factor VIII activity.
Madankollu, meta jkun hemm sustanza inibitura, id- dożi jridu jiġu mibdula skond kif jirrispondi l- pazjent, kif ukoll skond il - livelli ta ’ l- attività sorveljata tal- fattur VIII fil- plażma.
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.
These therapies should be directed by physicians with experience in the care of patients with haemophilia.
Dawn it- terapiji għandhom ikunu mmexxija minn tobba b’ esperjenza fil- kura tal - pazjenti li jsofru bl- emofilja.
Administration Dissolve the preparation as described in section 6.6.
Kif jingħata Dewweb il- preparazzjoni skond kif indikat f ’ sezzjoni 6. 6.
Helixate NexGen should be injected intravenously over several minutes.
Helixate NexGen għandu jingħata b’ injezzjoni ġol- vina fuq medda ta ’ numru ta ’ minuti.
The rate of administration should be determined by the patient’ s comfort level (maximal rate of infusion:
Ir- rata ta ’ amministrazzjoni għandha tiġi stabbilita skond kif qed iħossu l- pazjent (l- ogħla rata ta ’ infużjoni:
Helixate NexGen can be infused by continuous infusion.
Helixate NexGen jista ’ jingħata b’ infużjoni kontinwa.
The infusion rate should be calculated based on the clearance and the desired FVIII level.
Ir- rata ta ’ infużjoni għandha tiġi kkalkulata skond ir- rata ta ’ eliminazzjoni u l- livell mixtieq ta ’ FVIII.
Example: for a 75 kg patient with a clearance of 3 ml/ h/ kg, the initial infusion rate would be 3 IU/ h/ kg to achieve a FVIII level of 100%.
Eżempju: għal pazjent ta ’ 75 kg b’ rata ta ’ eliminazzjoni ta ’ 3 ml/ h/ kg, ir- rata inizjali ta ’ infużjoni għandha tkun ta ’ 3 IU/ h/ kg sakemm jintlaħaq livell ta ’ FVIII ta ’ 100%.
For calculation of ml/ hour, multiply infusion rate in IU/ h/ kg by kg bw/ concentration of solution (IU/ ml).
Għal kalkulazzjoni ta ’ ml/ siegħa, immultiplika r- rata ta ’ infużjoni f’ IU/ h/ kg b’ kg/ bw/ konċentrazzjoni ta ’ soluzzjoni (IU) ml
Clearance:
Rata ta ’
3 ml/ h/ kg
Rata ta ’ infużjoni għal
Desired plasma FVIII level
fil- plażma mixtieq
Infusion rate IU/ h/ kg
infużjoni IU/ h/ kg
Infusion rate for 75 kg patient ml/ h Concentrations of rFVIII solution 100 IU/ ml 200 IU/ ml 400 IU/ ml
Konċentrazzjoni ta ’ soluzzjoni rFVIII 100 IU/ ml 200 IU/ ml 400 IU/ ml
Higher infusion rates may be required in conditions with accelerated clearance during major bleedings or extensive tissue damage during surgical interventions.
Rati ta ’ infużjoni ogħla għandhom mnejn ikunu meħtieġa f’ kundizzjonijiet ta ’ rata ta ’ eliminazzjoni aktar aċċelerata matul fsadat maġġuri jew f’ każijiet ta ’ danni estensivi għat- tessuti matul interventi kirurġiċi.
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.
Rata ta ’ eliminazzjoni = rata ta ’ infużjoni/ livell ta ’ FVIII reali.
4 4.3 Contraindications
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Bħal fil- każ ta ’ kull prodott intravenuż ta ’ proteini, sensittività eċċessiva tat- tip li tikkaġuna allerġiji hija possibbli.
Patients should be made aware that the potential occurrence of chest tightness, dizziness, mild hypotension and nausea during infusion can constitute an early warning for hypersensitivity and anaphylactic reactions.
Il- pazjenti għandhom ikunu jafu li jekk jħossu għafis fis- sider, sturdament, pressjoni daqsxejn baxxa, u dardir waqt l- infużjoni, jista ’ jkun li dawn is- sintomi jkunu twissija bikrija ta 'sensittività eċċessiva u reazzjonijiet anafilattiċi.
Symptomatic treatment and therapy for hypersensitivity should be instituted as appropriate.
Kura sintomatika u terapija għas- sensittività eċċessiva għandu jibda kif xieraq.
If allergic or anaphylactic reactions occur, the injection/ infusion should be stopped immediately and patients should contact their physician.
Jekk isseħħu reazzjonijiet allerġiċi jew anafilattiċi, waqqaf l - injezzjoni/ infużjoni mill- ewwel, u l- pazjenti għandhom jikkuntattjaw lit- tabib tagħhom.
In case of shock, the current medical standards for shock treatment should be observed.
F’ każ ta ’ xokk, il- pazjent għandu jiġi kkurat skond l- proċedura standard attwali għal xokk.
The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A.
Il- formazzjoni ta’ anti- korpi li jinnewtralizzaw fattur VIII (sustanzi inibituri), hija komplikazzjoni magħrufa fil- ġestjoni ta ’ individwi li għandhom l- emofilija A.
These inhibitors are invariably IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Modified Bethesda Units (BU) per ml of plasma.
Dawn is- sustanzi inibituri huma immunoglobulini tat- tip IgG, li jaġixxu kontra l- attività pro- koagulanti tal- fattur VIII mkejla b 'Unitajiet Bethesda Mmodifikati (BU) għal kull ml ta ’ plażma.
The risk of developing inhibitors is correlated to the exposure to anti- haemophilic factor VIII and to genetic factors among others, this risk being highest within the first 20 exposure days.
Ir- riskju li wieħed jiżviluppa sustanzi inibituri jiddependi fuq kemm ikun espost għall- fattur VIII anti- emofiliku u għal fatturi ġenetiċi fost oħrajn, dan ir- riskju huwa l- ogħla fl- ewwel 20 jum wara li wieħed jkun ġie espost.
Rarely, inhibitors may develop after the first 100 exposure days.
Rarement, wieħed jista ’ jiżviluppa sustanzi inibituri wara l- ewwel 100 jum li wieħed jiġi espost.
Cases of recurrence of inhibitors (low titre) have been observed after switching from one recombinant factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.
Ġew osservati każijiet ta ’ rikorrenza ta ’ impedituri (titru baxx) wara li pazjenti bi storja li jiżviluppaw impedituri u li qabel kienu fuq trattament bi prodott ta ’ Fattur VIII rikombinanti ngħataw prodott ieħor u wara aktar minn 100 jum ta ’ espożizzjoni.
Patients treated with recombinant coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Pazjenti kkurati bil- fattur VIII rikombinanti tal- koagulazzjoni, għandhom jiġu ssorveljati b 'reqqa għal xi zvilupp ta ’ sustanzi inibituri permezz ta ’ osservazzjonijiet kliniċi u testijiet tal- laboratorju.
See also section 4.8 Undesirable effects.
Ara ukoll sezzjoni 4. 8, Effetti mhux mixtieqa.
In a clinical study about the use of continuous infusion in surgeries, heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions.
Fi studju kliniku dwar l- użu ta ’ infużjoni kontinwa f’ interventi kirurġiċi, l- eparina ġiet użata biex timpedixxi t- tromboflebite fis- sit ta ’ l- infużjoni bħal fil- każ ta ’ infużjonijiet intravenużi oħra fuq perijodu ta ’ żmien twil.
In the interest of the patients, it is recommended that, whenever possible, every time that Helixate NexGen 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 Helixate NexGen jiġi mogħti lilhom, l- isem u n- numru tal- lott tal- prodott jiġi reġistrat.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i. e. essentially “ sodium free”.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull kunjett, i. e essenzjalment huwa “ ħieles mis- sodju ”.
4.5 Interactions with other medicinal products and other forms of interaction
5 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
No interactions of Helixate NexGen with other medicinal products are known.
M’ hemmx prodotti mediċinali magħrufa li ma jaqblux ma ’ Helixate NexGen.
Animal reproduction studies have not been conducted with Helixate NexGen.
Ma ’ sarux studji fuq ir- riproduzzjoni fl- annimali b 'Helixate NexGen.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of Helixate NexGen during pregnancy and breast-feeding is not available.
Minħabba każijiet rari ta ’ l- emofilija A fin- nisa, l- esperjenza dwar l- użu ta ’ Helixate NexGen fit- tqala u t- treddigħ m' hiex disponibbli.
Therefore, Helixate NexGen should be used during pregnancy and lactation only if clearly indicated.
Għaldaqstant, Helixate NexGen għandu jintuża fit- tqala u t- treddigħ meta jkun hemm biss indikazzjoni ċara.
4.7 Effects on ability to drive or use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Helixate NexGen has no influence on the ability to drive or to use machines.
Helixate NexGen m’ għandux influenza fuq il- ħila biex issuq u tħaddem magni.
After administration of Helixate NexGen 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 'Helixate NexGen, ġew osservati f ’ każijiet rari kif preżentati fit- tabella li ġejja.
5 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Terminu ppreferut ta ’ MedDRA
MedDRA Preferred Term Factor VIII inhibition Dysgeusia Nausea
Inibizzjoni ta ’ Fattur VIII Disgewsja Nawsea
General disorders and administration site conditions Immune system disorders Investigations Nervous system disorders Skin and subcutaneous tissue disorders
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Disturbi fis- sistema immuni Investigazzjonijiet Disturbi fis- sistema nervuża Disturb fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Injection site reaction Pyrexia Allergic / Anaphylactic reaction Blood pressure abnormal Dizziness Pruritus Rash
Reazzjoni fis- sit ta ’ l- inejzzjoni Deni Reazzjoni Allerġika / Anafilattika Pressjoni tad- demm abnormali Stordament Ħakk Raxx
The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the management of individuals with haemophilia A.
Il- formazzjoni ta ’ anti- korpi li jinnewtralizzaw kontra komplikazzjoni magħrufa waqt fil- ġestjoni ta ’ individwi
In studies with recombinant factor VIII preparations, development of inhibitors is predominantly observed in previously untreated haemophiliacs.
fattur VIII rikombinanti intwera li sustanzi inibituri żviluppaw l- aktar f’ pazjenti li qatt qabel ma kienu ġew ikkurati għal- emofilja.
Patients should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Il- pazjenti għandhom ikunu ssorveljati bir- reqqa għal xi żvilupp ta ’ sustanzi inibituri permezz ta ’ osservazzjonijiet kliniċi xierqa u testijiet tal- laboratorju.
In clinical studies, Helixate NexGen 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, Helixate NexGen 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 Helixate NexGen developed inhibitors:
Ħamsa minn 37 (14%) pazjent PUP u 4 minn 23 (17%) pazjent MTP ittrattati b’ Helixate NexGen żviluppaw inibituri:
Overall 6 out of 60 (10%) with a titer above 10 BU and 3 out of 60 (5%) with a titer below 10 BU.
Globalment 6 minn 60 (10%) b’ valur ta ’ titer ’ il fuq minn 10 BU u 3 minn 60 (5%) b’ valur ta ’ titer inqas minn 10 BU.
The median number of exposure days at the time of inhibitor detection in these patients was 9 days (range 3 - 18 days).
In- numru medjan ta ’ ġranet ta ’ espożizzjoni fil- ħin ta ’ l- espożizzjoni kien ta ’ 9 ijiem (firxa 3 - 18- il jum).
The median number of exposure days in the clinical studies was 114 (range:
In- numru medjan ta ’ ġranet ta ’ espożizzjoni fl- istudji kliniċi kien ta ’ 114 (firxa:
Four of the five patients, who had not achieved 20 exposure days at the end of the study, ultimately achieved more than 20 exposure days in post-study follow-up and one of them developed a low titer inhibitor.
Erbgħa mill - ħames pazjenti li ma kienux laħqu 20 jum ta ’ espożizzjoni fi tmiem l- istudju, bażikament laħqu aktar minn 20 jum ta ’ espożizzjoni f’ follow- up wara l- istudju u wieħed minnhom żviluppa inibitur ta ’ titru baxx.
The fifth patient was lost to follow-up.
Il- ħames pazjent ma nstabx għal follow- up.
In clinical studies with 73 previously treated patients (PTP, defined as having more than 100 exposure days), followed over four years, no de-novo inhibitors were observed.
Fi studji kliniċi b’ 73 pazjent ittrattat minn qabel (PTP, imfisser bħala li kellhom aktar minn 100 jum ta ’ espożizzjoni), segwiti għal aktar minn 4 snin, ma ġew osservati l- ebda inibituri de novo.
In extensive post-registration studies with Helixate NexGen, involving more than 1000 patients the following was observed:
6 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ Helixate NexGen, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
Less than 0.2% PTP developed de-novo inhibitors.
Inqas minn 0. 2% PTP żviluppaw inibituri de novo.
In a subset defined as having less than 20 exposure days at study entry, less than 11% developed de-novo inhibitors.
F’ sottosett mfisser bħala li għandu anqas minn 20 jum ta ’ espożizzjoni mad- dħul ta ’ studju tiegħu, anqas minn 11% żviluppaw inibituri de- novo.
During studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation.
Waqt dawn l- istudji nstab li l- ebda pazjent ma żviluppa titri ta 'anti- korpi rilevanti kontra l- ammonti żgħar ħafna ta ’ proteini mill- ġrieden u mill- ħamster li kienu preżenti fil- preparazzjoni.
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 sections 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 sezzjonijiet 4. 3 u 4. 4).
No symptoms of overdose with recombinant coagulation factor VIII have been reported.
L- ebda każ ta ’ doża eċċesiva bil- fattur VIII rikombinanti għall- koagulazzjoni, ma ġie rrappurtat.
6 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.
When infused into a haemophiliac patient, factor VIII 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 VIII acts as a cofactor for activated factor 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.
Activated factor X converts prothrombin into thrombin.
Meta fattur X jkun attivat, huwa jbiddel il- prothrombin għal thrombin.
Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Thrombin ibiddel fibrinogen f’ fibrin u jifforma embolu.
Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII: C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a results of accidental or surgical trauma.
Dan jikkaġuna kwantità kbira ta ’ fsada mill- ġogi, muskoli, u organi interni f’ daqqa jew wara xi aċċident jew trawma kirurġika.
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 għal 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' tromboplastin parzjali attivat (aPTT).
The aPTT is prolonged in all haemophiliacs.
Il- perjodu ta ’ l- aPTT huwa itwal fil - pazjenti kollha li għandhom l- emofilja.
The degree and duration of aPTT normalisation observed after administration of Helixate NexGen 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 'Helixate NexGen 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 Helixate NexGen.
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 Helixate NexGen.
This result is similar to the reported values for factor VIII derived from human plasma.
Dan ir- riżultat huwa simili għal dak rappurtat għal fattur VIII li ġej mill- plażma tal- bniedem.
After administration of Helixate NexGen, 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 'Helixate NexGen, 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.
13 hours.
Dan ir- riżultat huwa ukoll simili għal dak miksub fil- każ tal- fattur VIII li ġej mill- plażma li l- medja tal- half- life terminali hi ta ’ madwar 13- il siegħa.
Additional pharmacokinetic parameters for Helixate NexGen for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 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).
5.3 Preclinical safety data
7 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for Helixate NexGen in laboratory animals (mouse, rat, rabbit, and dog).
Studji fuq annimali tal- laboratorju (ġurdien, far, fenek, u kelb) b' Helixate NexGen 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.
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 octocogalfa ngħata b mod ripetut, bħal studju fuq it- tossiċità riproduttiva, tossiċità kronika, u karċinoġeniċità.
No studies were performed on the mutagenic potential of Helixate NexGen, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of Helixate NexGen.
Ma sarux studji fuq il- possibiltà ta ’ effetti mutaġeniċi minn Helixate NexGen billi fuq prodott li ħareġ qabel Helixate NexGen ma kien hemm ebda effett mutaġeniku potenzjali kemm in vitro kif ukoll in vivo.
Powder Glycine Sodium chloride Calcium chloride Histidine Polysorbate 80 Sucrose
Trab Glycine Sodium chloride Calcium chloride Histidine Polysorbate 80 Sucrose
Solvent Water for injections
Solvent Ilma għall- injezzjoni
7 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 administration sets can be used because treatment failure can occur as a consequence of human coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Biex jingħata, għandu jintuża biss it- tagħmir provdut 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.
After reconstitution, the product should be used immediately.
Wara r- rikostituzzjoni, il- prodott għandu jintuża minnufih.
However, chemical and physical in-use stability has been demonstrated for 48 hours at 30°C.
Madankollu, l- istabbilità kimika u fiżika waqt l- użu ġiet murija għal 48 siegħa f’ temperatura ta ’ 30°C.
Keep the vials in the outer carton in order to protect from light.
Żomm il- kunjetti fil- kaxxa ta 'barra sabiex tilqa' mid - dawl.
The product when kept in its outer carton may be stored at ambient room temperature (up to 25°C) for a limited period of 3 months.
Il- prodott ippakkjat jista ’ jinżamm f ’ temperatura ambjentali (sa mhux ogħla minn temperatura ta ’ 25°C) għal perjodu limitat ta ’ 3 xhur.
In this case, the product expires at the end of this 3-month period; the new expiry date must be noted on the top of the outer carton.
F’ dan il- każ il- prodott jiskadi fl- aħħar tat- 3 xhur, id- data l- ġdida ta ’ l- iskadenza għandha tiġi mmarkata fuq in- naħa ta ’ fuq tal- kaxxa ta ’ barra.
Do not refrigerate after reconstitution.
Tagħmlux fil- friġġ wara li tirrikostitwixxi.
For single use only.
Uża darba biss.
Any unused solution must be discarded.
Armi kull soluzzjoni li ma tintużax.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Għal kondizzjonijiet ta ’ ħażna tal- prodott mediċinali rikostitwit, ara sezzjoni 6. 3
6.5 Nature and contents of container
8 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Each package of Helixate NexGen 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 ’ Helixate NexGen fih: • kunjett bit- trab (10 ml, ħġieġ trasparenti tip 1 kunjett magħluq b’ għatu griż 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 filter transfer device 20/ 20
- tagħmir tal- filter 1 li jitrasferixxi 20/ 20
Detailed instructions for preparation and administration are contained in the package leaflet provided with Helixate NexGen.
Struzzjonijiet dettaljati ta 'kif jiġi ppreparat u jingħata jinstabu fil- fuljett ta ’ tagħrif fil- pakett ta' Helixate NexGen.
Helixate NexGen powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Helixate NexGen għandu jiġi rikostitwit biss bis- solvent provdut (2, 5 ml ilma għall- injezzjoni) permezz tat- tagħmir Mix2Vial filter transfer device, li huwa provdut.
Reconstitution should be performed in accordance with good practices rules, particularly with attention to asepsis.
Ir- rikostituzzjoni għandha tiġi mwettqa b’ mod konformi ma ’ regoli ta ’ prattika tajba, b’ mod partikolari b’ attenzjoni għal asepsis.
Gently rotate the vial until all powder is dissolved.
Dawwar bil- mod il- kunjett sakemm iddewweb it- trab.
After reconstitution the solution is clear.
Wara r- rikostituzzjoni, is- soluzzjoni hija ċara.
Do not use Helixate NexGen if you notice visible particulate matter or turbidity.
Tużax Helixate NexGen jekk tara xi frak jew is- soluzzjoni tiġi mdardra.
After reconstitution, the solution is drawn through the Mix2Vial filter transfer device into the sterile disposable syringe (both supplied).
Wara li tirrikosstitwixxi l- prodott, iġbed is- soluzzjoni minn ġol - Mix2Vial transfer device għal ġos - siringa sterili li tntuża darba biss (provduti t- tnejn).
Bayer HealthCare AG D-51368 Leverkusen Germany
Bayer HealthCare AG D- 51368 Leverkusen Il- Ġermanja
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA 'L- EWWEL AWTORIZZAZZJONI / TIĠDID TA' L- AWTORIZZAZZJONI
04 August 2000 Date of last renewal:
04 Awissu 2000 Data ta 'tigdid ta ’ l- awtorizzazzjoni:
04 August 2005
04 Awissu 2005
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu.
Helixate NexGen 500 IU Powder and solvent for solution for injection.
Helixate NexGen 500 IU Trab u solvent għal soluzzjoni għall- injezzjoni
Recombinant Coagulation factor VIII, 500 IU/ vial.
Fattur VIII tal- koagulazzjoni rikombinanti 500 IU/ kunjett.
The product reconstituted with the accompanying 2.5 ml of water for injections contains approximately 200 IU octocog alfa/ ml.
Meta l- prodott jiġi rikostitwit b’ 2, 5 ml ilma għall- injezzjoni, li hu inkluż, il- prodott ikun fih madwar 200 IU octocog alfa/ ml.
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.
11 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.
11 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.
12 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
Known hypersensitivity to the active substance, to mouse or hamster protein or to any of the excipients.
Sensittività eċċessiva magħrufa, għas- sustanza attiva, għal proteini tal- ġrieden jew ħamster jew għal xi sustanzi mhux attivi.
4.5 Interactions with other medicinal products and other forms of interaction
13 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
13 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Terminu ppreferut ta ’ MedDRA
The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the management of individuals with haemophilia A.
Il- formazzjoni ta ’ anti- korpi li jinnewtralizzaw kontra l- fattur VIII (sustanzi inibituri) hija komplikazzjoni magħrufa waqt fil- ġestjoni ta ’ individwi bl- emofilija A.
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 għal- emofilja.
In extensive post-registration studies with Helixate NexGen, involving more than 1000 patients the following was observed:
14 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ Helixate NexGen, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
14 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.
5.3 Preclinical safety data
15 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
15 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
6.5 Nature and contents of container
16 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Helixate NexGen 1000 IU Powder and solvent for solution for injection.
Helixate NexGen 1000 IU Trab u solvent għal soluzzjoni għall- injezzjoni
Recombinant Coagulation factor VIII, 1000 IU/ vial.
Fattur VIII tal- koagulazzjoni rikombinanti 1000 IU/ kunjett.
The product reconstituted with the accompanying 2.5 ml of water for injections contains approximately 400 IU octocog alfa/ ml.
Meta l- prodott jiġi rikostitwit b’ 2, 5 ml ilma għall- injezzjoni, li hu inkluż, il- prodott ikun fih madwar 400 IU octocog alfa/ ml.
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.
19 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.
19 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.
20 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
4.5 Interactions with other medicinal products and other forms of interaction
21 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
21 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Terminu ppreferut ta ’ MedDRA
In extensive post-registration studies with Helixate NexGen, involving more than 1000 patients the following was observed:
22 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ Helixate NexGen, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
22 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.
5.3 Preclinical safety data
23 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
23 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
6.5 Nature and contents of container
24 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Helixate NexGen 2000 IU Powder and solvent for solution for injection.
Helixate NexGen 2000 IU Trab u solvent għal soluzzjoni għall- injezzjoni
Recombinant Coagulation factor VIII, 2000 IU/ vial.
Fattur VIII tal- koagulazzjoni rikombinanti 2000 IU/ kunjett.
The product reconstituted with the accompanying 5.0 ml of water for injections contains approximately 400 IU octocog alfa/ ml.
Meta l- prodott jiġi rikostitwit b’ 5, 0 ml ilma għall- injezzjoni, li hu inkluż, il- prodott ikun fih madwar 400 IU octocog alfa/ ml.
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.
27 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.
27 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.
28 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
4.5 Interactions with other medicinal products and other forms of interaction
29 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
29 MedDRA System Organ Class Blood and lymphatic sytem disorders Gastrointestinal disorders
Terminu ppreferut ta ’ MedDRA
In extensive post-registration studies with Helixate NexGen, involving more than 1000 patients the following was observed:
30 Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ Helixate NexGen, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
30 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.
5.3 Preclinical safety data
31 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
31 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
6.5 Nature and contents of container
32 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Helixate NexGen powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Helixate NexGen għandu jiġi rikostitwit biss bis- solvent provdut (5, 0 ml ilma għall- injezzjoni) permezz tat- tagħmir Mix2Vial filter transfer device, li huwa provdut.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE AND MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE
MANIFATTUR TAS- SUSTANZA( I) BIJOLOĠIKA ATTIVA U D- DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL - LOTT B.
34 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
Name and address of the manufacturer(s) of the biological active substance
Isem u indirizz tal- manufattur tas- sustanza bijoloġika attiva
Bayer Corporation (license holder) Bayer HealthCare LLC 800 Dwight Way Berkeley, CA 94710 USA
Bayer Corporation (detentur tal- liċenzja) Bayer HealthCare LLC 800 Dwight Way Berkeley, CA 94710 USA
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manifattur responsabbli mill- ħruġ tal- lott.
Bellaria, 35 I-53010 Torri-Sovicille (SI) Italy
Bellaria, 35 I- 53010 Torri- Sovicille (SI) L- Italja
Summary of Product Characteristics, section 4.2):
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2)
The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 2 ippreżentat f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq, tinsab f’ postha u qed tiffunzjona qabel u waqt li l- prodott qiegħed fis- suq.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.3 presented in Module 1.8.2 of the Risk Management Plan (RMP) of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detenetur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u attivitajiet ta ’ farmakoviġilanza addizzjonali dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem f’ verżjoni 1. 3 ippreżentat f’ Modulu 1. 8. 2 tal- Pjan ta ’ Ġestjoni dwar ir- Riskju (RMP) u l- Applikazzjoni ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti ta ’ l- RMP miftiehem mis - CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
(PSUR - Periodic Safety Update Report)
35 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.
35 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.
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Helixate NexGen 250 IU Powder and solvent for solution for injection
Helixate NexGen 250 IU Trab u solvent għal soluzzjoni għall- injezzjoni
Recombinant coagulation factor VIII (octocog alfa)
Fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa)
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA ATTIVA
1 vial:
Kunjett 1:
250 IU octocog alfa (100 IU/ ml after reconstitution).
250 IU octocog alfa (100 IU/ ml wara r- rikostituzzjoni).
1 vial with powder for solution for injection.
Kunjett 1 bi trab għal soluzzjoni għall- injezzjoni.
1 vial with 2.5 ml water for injections.
Kunjett 1 b '2, 5 ml ilma għall- injezzjoni.
For intravenous use, single dose administration only.
Għal użu ġol- vina, doża li tintuża darba biss.
{MM/ YYYY} EXP (End of the 3 month period, if stored at room temperature):...........
EXP (Fi tmiem perjodu ta '3 xhur jekk maħżuna f' temperatura ambjentali):...........
Do not use after this date.
Tużax wara din id- data.
Store in a refrigerator (2°C - 8°C).
Aħżen fil- friġġ (2°C – 8°C).
Keep the vials in the outer carton in order to protect from light.
Żomm il- kunjetti fil- kaxxa ta 'barra sabiex tilqa' mid- dawl.
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 top of the carton.
Il- prodott fil- pakkett ta ’ barra jista 'jinħażen fit- temperatura tal- kamra (< 25°C) għal perjodu wieħed sa 3 xhur; Għandek tniżżel d- data ta' meta jiskadi fuq in- naħa ta 'fuq tal- kaxxa.
Use the reconstituted solution immediately.
Uża mill- ewwel wara li tirrikostitwixxi l- prodott.
Do not refrigerate after reconstitution.
Tagħmilx is- soluzzjoni rikostitwita fil- friġġ.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TA D- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Bayer HealthCare AG, D-51368 Leverkusen, Germany
Bayer HealthCare AG, D- 51368 Leverkusen, Il- Ġermanja
40 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL WITH POWDER FOR SOLUTION FOR INJECTION
KUNJETT BIT- TRAB GĦAL SOLUZZJONI GĦALL- INJEZZJONI
Helixate NexGen 250 IU Powder for solution for injection
Helixate NexGen 250 IU Trab għal soluzzjoni għall- injezzjoni
For intravenous use.
Għal użu ġol- vina.
41 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
41 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL WITH 2.5 ML WATER FOR INJECTIONS
KUNJETT B '2, 5 ML ILMA GĦALL- INJEZZJONI
Water for injections 2.5 ml
Ilma għall- injezzjoni 2, 5 ml
For reconstitution of Helixate NexGen, see package leaflet.
Għar- rikostituzzjoni ta 'Helixate NexGen, ara l- fuljett ta' tagħrif.
Use entire content.
Uża l- kontenut kollu.
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Helixate NexGen 500 IU Powder and solvent for solution for injection
Helixate NexGen 500 IU Trab u solvent għal soluzzjoni għall- injezzjoni
500 IU octocog alfa (200 IU/ ml after reconstitution).
500 IU octocog alfa (200 IU/ ml wara r- rikostituzzjoni).
44 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Helixate NexGen 500 IU Powder for solution for injection
Helixate NexGen 500 IU Trab għal soluzzjoni għall- injezzjoni
45 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
45 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
46 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Helixate NexGen 1000 IU Powder and solvent for solution for injection
Helixate NexGen 1000 IU Trab u solvent għal soluzzjoni għall- injezzjoni
1000 IU octocog alfa (400 IU/ ml after reconstitution).
1000 IU octocog alfa (400 IU/ ml wara r- rikostituzzjoni).
Helixate NexGen 1000 IU Powder for solution for injection
Helixate NexGen 1000 IU Trab għal soluzzjoni għall- injezzjoni
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
49 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
50 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Helixate NexGen 2000 IU Powder and solvent for solution for injection
Helixate NexGen 2000 IU Trab u solvent għal soluzzjoni għall- injezzjoni
2000 IU octocog alfa (400 IU/ ml after reconstitution).
2000 IU octocog alfa (400 IU/ ml wara r- rikostituzzjoni).
1 vial with 5.0 ml water for injections.
Kunjett 1 b '5, 0 ml ilma għall- injezzjoni.
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
52 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Helixate NexGen 2000 IU Powder for solution for injection
Helixate NexGen 2000 IU Trab għal soluzzjoni għall- injezzjoni
53 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
53 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL WITH 5.0 ML WATER FOR INJECTIONS
KUNJETT B '5, 0 ML ILMA GĦALL- INJEZZJONI
Water for injections 5.0 ml
Ilma għall- injezzjoni 5, 0 ml
55 PACKAGE LEAFLET:
55 FULJETT TA 'TAGĦRIF:
Helixate NexGen 250 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Helixate NexGen 250 IU trab u solvent għal soluzzjoni għall- injezzjoni Fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa)
- If any of the side effects gets serious, or if you notice any site effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What Helixate NexGen 250 IU is and what it is used for 2.
X' inhu Helixate NexGen 250 IU u għalxiex jintuża 2.
Before you use Helixate NexGen 250 IU 3.
Qabel ma tieħu Helixate NexGen 250 IU 3.
How to use Helixate NexGen 250 IU 4.
Kif għandek tieħu Helixate NexGen 250 IU 4.
How to store Helixate NexGen 250 IU 6.
Kif taħżen Helixate NexGen 250 IU 6.
WHAT Helixate NexGen 250 IU IS AND WHAT IT IS USED FOR
X' INHU Helixate NexGen 250 IU U GĦALXIEX JINTUŻA
One vial with powder for solution for injection nominally contains 250 IU octocog alfa (IU equals International Units).
Kunjett wieħed bit- trab għal soluzzjoni għall- injezzjoni li b' mod nominali fih 250 IU octocog alfa (IU tfisser Unitajiet Internazzjonali).