qanastek/EMEA-V3 huggingface dataset:
After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 100 IU/ ml.
Wara li jiġi rikostitwit bil- volum xieraq ta 'solvent (ilma għall - injezzjoni) kull kunjett ikun fih 100 IU/ ml octocog alfa.
Pharmacotherapeutic group: blood coagulation factor VIII (ATC-Code B02B D02).
Kategorija farmakoterapewtika: fattur VIII tal- koagulazzjoni tad- demm (Kodiċi ATC B02B D02).
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Għall- kura u l- profilassi tal- fsada f 'pazjenti li għandhom emofilja A (nuqqas konġenitali tal- fattur VIII).
This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Dan il- prodott mediċinali ma fihx il- fattur von Willebrand u għalhekk m' hux intiż għall- kura tal- marda von Willebrand.
BEFORE YOU USE Helixate NexGen 250 IU
QABEL MA TIEĦU Helixate NexGen 250 IU
Do not use Helixate NexGen 250 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of Helixate NexGen 250 IU.
Tużax Helixate NexGen 250 IU jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal octocog alfa, proteini tal- ġurdien jew għal proteini tal- ħemster jew għal xi wieħed mis- sustanzi l- oħra ta 'Helixate NexGen 250 IU.
If you are unsure about this, ask your doctor.
Jekk int m' intiex żgur dwar dan, staqsi lit- tabib tiegħek.
Take special care with Helixate NexGen 250 IU as there is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction).
Oqgħod attent ħafna b' Helixate NexGen 250 IU billi hemm ċans rari li jista jkollok reazzjoni anafilattika (reazzjoni allerġika f' daqqa u serja).
If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing an allergic reaction to Helixate NexGen 250 IU.
Jekk int tħoss għafsa fis- sider, sturdamenti, tħossok dgħajjef jew ma tiflaħx, tħossok stordut waqt li int bil- wieqfa, jista 'jkun li qed tbati minn reazzjoni allerġika għal Helixate NexGen 250 IU.
If this occurs, stop administering the product immediately and seek medical advice.
Jekk dan jiġri, waqqaf l- għotja tal- prodott minnufih u fittex għajnuna medika.
Your doctor may wish to carry out tests to ensure that your current dose of Helixate NexGen 250 IU is sufficient to reach and maintain adequate factor VIII levels.
It- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jiżgura li d- doża attwali ta 'Helixate NexGen 250 IU hija biżżejjed biex tilħaq u żżomm livelli xierqa ta' Fattur VIII.
If your bleeding is not being controlled with Helixate NexGen 250 IU, consult your doctor immediately.
Jekk il- fsada tiegħek mhux qed tiġi kkontrollata b' Helixate NexGen 250 IU, ikkonsulta mat- tabib tiegħek minnufih.
You may have developed factor VIII inhibitors and your doctor may wish to carry out tests to confirm this.
Jista 'jkun li żviluppajt inibituri għall- fattur VIII u t- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jikkonferma dan.
Factor VIII inhibitors are antibodies in the blood which block the factor VIII you are using.
Inibituri għall- fattur VIII huma anti- korpi fid- demm li jwaqqfu l- fattur VIII li qed tieħu.
This makes factor VIII less effective in controlling bleeding.
Dan jagħmel il- fattur VIII anqas effettiv fil- kontroll tal- fsada.
56 If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.
56 Jekk qabel tkun żviluppajt inibitur ta ’ fattur VIII u taqleb il- prodotti ta ’ fattur VIII, tista ’ tkun f’ riskju li l- inibitur jerġa ’ jitfaċċa.
Using other medicines Interactions with other medicines are not known.
Meta tieħu mediċini oħra M’ hemmx prodotti mediċinali magħrufa li ma jaqblux ma ’ Helixate NexGen.
However, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Madankollu, jekk jogħġbok għarraf it- tabib tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mhux bir- riċetta.
Pregnancy and breast-feeding Based on the rare occurrence of haemophilia A in women, experience regarding the use of Helixate NexGen 250 IU during pregnancy and breast-feeding is not available.
Tqala u Treddigħ Minħabba każijiet rari ta ’ emofilija A fin- nisa, l- esperjenza dwar l- użu ta ’ Helixate NexGen 250 IU fit- tqala u t- treddigħ m' hiex disponibbli.
Therefore, if you are pregnant or breast-feeding consult your doctor before using this product.
Għaldaqstant, jekk inti tqila jew qed tredda, ikonsulta mat - tabib tiegħek qabel ma tuża l- prodott.
No effects on the ability to drive or use machines have been observed.
L- ebda effett fuq il- ħila ta ’ sewqan u t- tħaddim ta ’ magni ma ’ ġie osservat.
Important information about some of the ingredients of Helixate NexGen 250 IU This medicinal product contain less than 1 mmol sodium (23 mg) per vial, i. e. essentially “ sodium- free”.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Helixate NexGen 250 IU Dan il- prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull kunjett, i. e essenzjalment huwa “ ħieles mis- sodju ”.
HOW TO USE Helixate NexGen 250 IU
KIF GĦANDEK TIEĦU Helixate NexGen 250 IU
Helixate NexGen 250 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
Helixate NexGen 250 IU huwa intiż għall- użu ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Aseptic conditions (meaning clean and germ free) are required during reconstitution and administration.
Kondizzjonijiet asettiċi (jiġifieri ta 'ndafa u mingħajr mikrobi) huma meħtieġa waqt ir - rikostituzzjoni u l- għoti.
Use only the medical devices for reconstitution and administration provided with each package of Helixate NexGen 250 IU.
Uża biss it- tagħmir għar- rikostituzzjoni u l- għotja provduti fil- pakkett ta 'Helixate NexGen 250 IU.
Helixate NexGen 250 IU must not be mixed with other infusion solutions.
Helixate NexGen 250 IU m' għandux jiġi mħallat ma 'soluzzjonijiet oħra ta' l- infużjoni.
Do not use solutions containing visible particles or that are cloudy.
Tużax soluzzjonijiet li jkun fihom frak viżibbli jew li jidhru mdardra.
Follow the directions given by your doctor closely and use the instructions below as a guide:
Segwi l - istruzzjonijiet mogħtija mit- tabib tiegħek b 'kawtela u uża l- istruzzjonijiet t' hawn isfel bħala gwida:
Wash hands thoroughly using soap and warm water.
Aħsel idejk sew bis- sapun u l- ilma fietel.
Warm both unopened vials in your hands to a comfortable temperature (do not exceed 37 °C).
Saħħan iż- żewġ kunjetti b' idejk sakemm jilħqu temperatura li hija komda (taqbizx 37°C).
Ensure product and diluent vial flip caps are removed and the stoppers are treated with an aseptic solution and allowed to dry
Iżgura li l- għotjien li jinqalgħu bis- saba ’ tal- prodott u d- dilwent huma mneħħija u li t- tappijiet huma minsuħa minn soluzzjoni
Open the Mix2Vial package by peeling away the lid.
Iftaħ il- pakkett ta ’ Mix2Vial billi tqaxxar l- għatu.
Carefully remove the package from the Mix2Vial set.
Poġġi l- kunjett tad- dilwent fuq wiċċ ċatt u nadif u żomm il - kunjett sew.
Make sure that you only pull up the package and not the Mix2Vial set.
Qiegħed il- Mix2Vial flimkien mal- pakkett u poġġi t- tarf ikħal fuq it- tapp il- blu.
With the product vial firmly on a surface, invert the diluent vial with set attached and snap the transparent adapter onto the product vial stopper.
Bil- kunjett tal- prodott qegħda soda fuq il- wiċċ, eqleb il- kunjett tad- dilwent bis- sett mehmuż u daħħal l- adapter trasparenti fuq it- tapp tal- kunjett tal- prodott.
The diluent will automatically transfer into the product vial.
Id- dilwent għandu awtomatikament jittrasferixxi għal ġoll- kunjett tal- prodott.
Do not shake vial.
Bil- kunjett tad- dilwent u tal- prodott għadhom mehmużin bil - mod dawwar il- kunjett tal- prodott sabiex tiżgura li l- prodott
With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the diluent-side of the Mix2Vial set and unscrew the set into two pieces.
B’ id waħda aqbad il- parti tal- prodott tas- sett ta ’ Mix2Vial u bl - id l- oħra aqbad il- parti differenti tal- kunjett, il- parti tad- dilwent tal- Mix2Vial u żvita is- sett f’ żewġ biċċiet.
Draw air (3 ml) into an empty, sterile syringe.
Iġbed l- arja (3 ml) f’ siringa vojta u sterili.
While the product vial is upright, connect the syringe to the Mix2Vial set.
Meta l- kunjett tal- prodott tkun wieqfa, qabbad is- siringa mas- sett ta ’ Mix2Vial.
Inject air into the product vial.
Injetta l- arja fil- kunjett tal- prodott.
Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the Mix2Vial set from the syringe.
Filwaqt li żżomm il- planġer tas- siringa 'l isfel, eqleb is- sistema rasha' l isfel u iġbed il- konċentrat fis- siringa billi tiġbed il - planġer lura bil- mod.
Hold the syringe upright and push the plunger until no air is left in the syringe.
Żomm is -
Apply a tourniquet.
Applika t- turnikett.
Determine the point of injection and prepare antiseptically.
Għażel il- post ta ’ l- injezzjoni u lestih b' mod antisettiku.
Puncture the vein and secure the venipuncture set with a plaster.
Daħħal fil- vina u żomm is- sett li jtaqqab il- vina f’ postu permezz ta ’ ġbajra.
Remove tourniquet.
Neħħi t- turnikett.
Inject the solution intravenously over several minutes, keeping an eye on the position of the needle.
Injetta s- soluzzjoni ġol- vina fuq medda ta ’ ħin, waqt li żżomm għajnejk fuq il- pożizzjoni tal- labra.
The rate of administration should be determined by the patient’ s comfort (maximum rate of infusion:
Ir- rata ta ’ l- għotja għandu jiġi stabbilit skond il- qagħda tal- pazjent (rata massima ta 'infużjoni:
If no further dose is required, remove the venipuncture set and syringe.
Jekk ikun hemm bżonn li doża oħra tiġi mogħtija, uża siringa ġdida bil- prodott jiġi rikostitwit kif deskritt hawn fuq.
2 minutes.
19.
The amount of Helixate NexGen 250 IU you should use and how often you use it depends on many factors such as your weight, the severity of your haemophilia, the site and extent of bleeding, the amount of
Fl- aħħar, qiegħed ġbajra tal- pressjoni għal fuq il- ferita.
11 58 factor VIII inhibitors that you may have and the factor VIII level required.
11 58 L- ammont ta ’ Helixate NexGen 250 IU li għandek tuża jiddependi fuq ħafna fatturi bħal piż tal- ġisem, kemm hija severa l- emofilja, kemm hi kbira u minn fejn hi l- fsada, l- għadd ta ’ sustanzi inibituri tal - fattur VIII li jista ’ jkollok, u l- livell tal- fattur VIII meħtieġ.
Your doctor will calculate the dose of Helixate NexGen 250 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
It- tabib tiegħek ser jikkalkula d- doża ta ’ Helixate NexGen 250 IU u kemm- il darba trid tużah sabiex jkollok il- livell ta ’ l- attività meħtieġa tal- fattur VIII fid- demm tiegħek.
He will do this according to your particular needs using the formulae below.
Huwa jagħmel dan skond il - ħtiġijiet tiegħek billi juża l- formuli ta 'hawn taħt:
In the case of the haemorrhagic events listed, the factor VIII activity should not fall below the given level (in% of normal) in the corresponding period:
F ’ każijiet ta ’ l- emorraġiji elenkati, il- livell ta ’ l- attività tal- fattur VIII, ma tridx ikun anqas mil- livell indikat (bħala% tan- normal) waqt dan il- perjodu:
Frequency of doses (hours)/
Qawwa ta ’ l- emorraġija / Tip ta ’ proċedura kirurġika Emorraġija
required (%) (IU/ dl)
Livell ta’ Fattur VIII meħtieġ (%) (IU/ dl)
Duration of therapy (days)
Frekwenza tad- dożi (sigħat) / Dewmien tat- terapija (ġranet) Irrepeti d- doża kull 12 sa 24 siegħa.
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.
Your doctor should always adapt the amount of Helixate NexGen 250 IU to be administered and the frequency of administration according to the clinical effectiveness in your individual case.
59 It- tabib tiegħek għandu dejjem jadatta l- ammont ta 'Helixate NexGen 250 IU li jiġi mogħti u l - frekwenza ta' l- għotja skond l- effettività klinika fil- każ tiegħek.
Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.
F' ċerti każi jista 'jkun hemm bżonn ta' ammonti akbar minn dawk ikkalkulati, speċjalment fil- każ ta 'l- ewwel doża.
59 If you are using Helixate NexGen 250 IU to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Jekk qed tuża Helixate NexGen 250 IU biex tevita l- fsada (profilassi), it- tabib tiegħek ser jikkalkula d - doża għalik.
This will usually be in the range of 20 to 60 IU of octocog alfa per kg of body weight, administered at intervals of 2 to 3 days.
Din ġenerlament tkun fuq firxa ta 'bejn 20 sa 60 IU ta' octocog alfa kull kg ta 'piż tal - ġisem, mogħti f' intervalli ta 'jumejn sa 3 ijiem.
However, in some cases, especially younger patients, shorter dose intervals or higher doses may be necessary.
Madankollu, f 'ċerti każi, speċjalment f' pazjenti żgħar jaf ikun meħtieġ li d- dożi jingħataw aktar ta' spiss jew id- dożi jkunu aktar għoljin.
Although dosage can be estimated by the calculations presented above, it is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that adequate factor VIII levels have been reached and are maintained.
Għalkemm id- doża tista 'tiġi stmata fuq il- kalkulazzjonijiet mogħtija hawn fuq, huwa rakkomandat bil- qawwa li jsiru testijiet xierqa fil- laboratorju tal- plażma f' intervalli xierqa sabiex jiġi żgurat li livelli tal- fattur VIII ikunu ġew milħuqa u miżmuma.
In the case of major surgical interventions in particular, a precise monitoring of the substitution therapy by means of coagulation analysis is indispensable.
Fil- każ ta 'intervent kirurġiku maġġur, monitoraġġ preċiż tat- terapija ta' sostituzzjoni permezz ta 'l- analiżi ta' koagulazzjoni huwa indispensabbli.
If the factor VIII level of your plasma fails to reach expected levels, or if bleeding is not controlled after apparently adequate dosage, the presence of factor VIII inhibitors should be suspected.
Jekk il- livell tal- fattur VIII fil- plażma jonqos milli jilħaq il- livelli mixtieqa, jew jekk il- fsada mhiex ikkontrollata wara doża li tkun tidher xierqa, il- preżenza ta 'inibituri għandu jiġi suspettat.
By appropriate laboratory procedures, the presence of factor VIII inhibitors must be checked and quantified by an experienced doctor.
Permezz ta 'proċeduri xierqa tal- laboratorju, il- preżenza ta' inibituri għal fattur VIII għandu jiġi ċċekjat u kwantifikat minn tabib bl- esperjenza.
If you have the impression that the effect of Helixate NexGen 250 IU is too strong or too weak, talk to your doctor.
Jekk inti tal- fehma li l- effett ta 'Helixate NexGen 250 IU huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
Patients with inhibitors If you have been informed by your doctor that you have developed factor VIII inhibitors you will possibly be required to use a larger amount of Helixate NexGen than previously to control a bleeding.
Pazjenti bl- inibituri Jekk ġejt infurmat mit- tabib tieghek li żviluppajt l- inibituri tal- fatturi VIII għandek mnejn ikollok bżonn ta 'ammont akbar ta' Helixate NexGen minn qabel biex tikkontrolla l- fsada.
If this dose does not control your bleeding your doctor may consider the use of an additional product, factor VIIa concentrate or (activated) prothrombin complex concentrate.
Jekk din id- doża ma tikkontrollax il- fsada t- tabib tiegħek jista 'jikkonsidra l- użu ta' prodott ieħor, konċentrat ta 'fattur VIIa jew kumpless konċentrat ta ’ prothrombin (attivat).
Do not increase the dose of Helixate NexGen you use to control your bleeding without consulting your doctor.
Iżżidtx id- doża ta 'Helixate NexGen li tuża biex tikkontrolla l- fsada mingħajr ma tikkonsulta mat- tabib tiegħek.
Speak to your doctor if you would like further information on this.
Kellem lit- tabib tiegħek jekk tkun trid aktar informazzjoni dwar dan.
These therapies should be directed by doctors with experience in the care of patients with haemophilia A.
Dawn it- terapiji għandhom ikunu kkontrollati minn tobba li għandhom esperjenza fil- kura ta 'pazjenti b’ emofilja A.
Helixate NexGen 250 IU 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 ’ l - għotja għandha tiġi stabbilita skond kif iħossu l- pazjent (l- ogħla rata ta ’ l- injezzjoni:
Your doctor will tell you, how often and at what intervals Helixate NexGen 250 IU is to be administered.
It- tabib tiegħek għandu jgħidlek, kemm ta 'spiss u wara kemm Helixate NexGen 250 IU għandu jiġi meħud.
Usually, the substitution therapy with Helixate NexGen 250 IU is a life-time treatment.
Ġeneralment, it- terapija ta 'sostituzzjoni b' Helixate NexGen 250 IU huwa trattament tul il- ħajja kollha tal- pazjent.
If you use more Helixate NexGen 250 IU than you should:
Jekk tieħu aktar Helixate NexGen 250 IU milli suppost għandek:
No symptoms of overdosage with recombinant coagulation factor VIII have been reported.
L- ebda sintomu ta 'doża eċċessiva bil- fattur VIII rikombinanti għal koagulazzjoni ma ġie rrapurtat.
If you have used more Helixate NexGen 250 IU than you should, please inform your doctor.
Jekk tuża aktar Helixate NexGen 250 IU milli għandek bżonn, għarraf it- tabib tiegħek.
If you forget to use Helixate NexGen 250 IU: • Proceed with the next administration immediately and continue at regular intervals as advised by your doctor. • Do not take a double dose to make up for a forgotten doses.
Jekk tinsa tieħu Helixate NexGen 250 IU: • Kompli bl- għotja li jmiss minnufih u ssokta f' intervalli regolari kif rakkomandat mit- tabib tiegħek • M' għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using Helixate NexGen 250 IU Do not stop using Helixate NexGen 250 IU without consulting your doctor.
Jekk tieqaf tieħu Helixate NexGen 250 IU Tieqafx tieħu Helixate NexGen 250 IU mingħajr ma tikkonsulta t- tabib tiegħek.
Like all medicines, Helixate NexGen 250 IU can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, Helixate NexGen 250 IU jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In rare cases, you may notice any of the following side effects after administration of Helixate NexGen 250 IU: • rash/ itchy rash, local reactions at the injection site (e. g. burning sensation, temporary redness) • hypersensitivity reactions (e. g. tightness of the chest/ general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing) • unusual taste in the mouth • fever.
F' każijiet rari, tista tinnota xi wieħed mill- effetti oħra li jista jkollu li ġejjin wara l- għotja ta 'Helixate NexGen 250 IU: • raxx/ ħakk tal- ġilda, reazzjonijiet fil post ta ’ l- injezzjoni (eż. ħruq, eritema temporanja) • reazzjonijiet ta' sensittività eċċessiva (eż. għafsa tas- sider/ tħossok ma tiflaħx, sturdament u dardir u pressjoni tad- demm kemmxejn baxxa, li tista 'tagħmlek dgħajjef waqt li tkun bil - wieqfa) • togħma mhux tas- soltu fil- ħalq • deni.
Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
If you notice any of the following symptoms during injection/ infusion: • chest tightness/ general feeling of being unwell • dizziness • mild hypotension (mildly reduced blood pressure, which may make you feel faint upon standing) • nausea this can constitute an early warning for hypersensitivity and anaphylactic reactions.
Jekk tinnota xi wieħed minn dawn is- sintomi waqt l- injezzjoni/ infużjoni: • għafsa fis- sider/ tħossok ma tiflahx • sturdament • pressjoni baxxa tad- demm ħafifa (pressjoni tad- demm mnaqqsa kemmxejn, li tista 'tagħmlek sturdut waqt li tkun bil- wieqfa) • dardir jista' jkun li din tkun indikazzjoni bikrija tas- sensittività eċċessiva u reazzjonijiet anafilattiċi.
If allergic or anaphylactic reactions occur, the injection/ infusion should be stopped immediately.
Jekk iseħħu reazzjonijiet allerġiċi u anafilattiċi, waqqaf l- injezzjoni/ infużjoni minnufih.
Please consult your doctor immediately.
Jekk jogħġbok ikkonsulta mat- tabib mal- ewwel.
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 relevanti kontra ammonti żgħar ta ’ proteini mill- ġrieden u mill- ħamster li kienu preżenti fil- prodott.
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.
Madankollu, xorta hemm possibbiltà ta ’ reazzjonijiet allerġiċi għas- sustanzi, eż: ammonti żgħar ta ’ proteina tal- ġurdien jew ħamster preżenti fil- prodott f 'ċerti pazjenti sensittivi.
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 il- fattur VIII (sustanzi inibituri) hija komplikazzjoni magħrufa waqt il- kura ta ’ individwi b’ emofilija A.
In studies with recombinant factor VIII preparations, development of inhibitors is predominantly observed in previously untreated haemophiliacs.
Fi studji bi prodotti li fihom il- fattur VIII rikombinanti, intwera li sustanzi inibituri żviluppaw l- aktar f’ pazjenti li qatt qabel ma kienu ġew ikkurati għall- emofilja.
You should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Għandek tiġi sorveljat 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 23 pazjent pedjatriku minimamemt ittrattati (MTPs, imfisser bħala li kellhom espożizzjoni ugwali għal jew inqas minn 4 ijiem).
In extensive post-registration studies with Helixate NexGen, involving more than 1000 patients the following was observed:
Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ Helixate NexGen, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
61 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE Helixate NexGen 250 IU
KIF TAĦŻEN Helixate NexGen 250 IU
In this case, the product expires at the end of this 3-month period; you must note the new expiry date on the top of the outer carton.
Tista 'żżomm il- prodott fil- pakkett fit- temperatura tal- kamra (sa 25°C) għal perjodu wieħed sa 3 xhur; F' dak il- każ, il- prodott jiskadi fl- aħħar tat- 3 xhur; Għandek tniżżel id- data l- ġdida ta' meta jiskadi fuq in- naħa ta 'fuq tal- kaxxa ta’ barra.
Do not refrigerate the solution after reconstitution.
Tagħmilx is- soluzzjoni rikostitwita fil- friġġ.
The reconstituted solution should be used immediately.
Uża mill- ewwel wara li tirrikostitwixxi l- prodott.
This product is for single use only.
Dan il - prodott qiegħed biex jintuża darba biss.
Any unused solution must be discarded.
Kull soluzzjoni mhux użata għandha tintrema.
Do not use Helixate NexGen 250 IU after the expiry date which is stated on labels and cartons.
M' għandekx tuża Helixate NexGen 250 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l- kartun.
The expiry date refers to the last day of that month.
Id- data ta ’ l- iskadenza tirreferi għal- aħħar jum ta ’ dak ix- xahar.
Do not use Helixate NexGen 250 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża Helixate NexGen 250 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
What Helixate NexGen 250 IU contains
X’ fih Helixate NexGen 250 IU
The other ingredients are glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, and sucrose.
Trab Is- sustanza attiva hi l- Fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa) Is- sustanzi l- oħra huma glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, u sucrose
Water for injections.
Solvent Ilma għall- injezzjoni.
What Helixate NexGen 250 IU looks like and content of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Helixate NexGen 250 IU is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake.
Helixate NexGen 250 IU jiġi bħala trab u solvent għall- soluzzjoni għal injezzjoni u huwa trab xott jew kejk ta ’ lewn bajdani li jkanġi ftit fl- isfar.
Medical devices for reconstitution and administration are provided with each package of Helixate NexGen 250 IU.
Wara r- rikostituzzjoni s- soluzzjoni hija ċara. Tagħmir mediku għar- rikostituzzjoni u l- għoti jiġu ma ’ kull pakkett ta ’ Helixate NexGen 250 IU.
Marketing authorisation Holder and Manufacturer
Id- detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
Bayer HealthCare AG D-51368 Leverkusen Germany
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Bayer HealthCare AG D- 51368 Leverkusen Il- Ġermanja
Bayer HealthCare Manufacturing S. r. l.
Manifattur Bayer HealthCare Manufacturing S. r. l.
Bellaria, 35 I-53010 Torri-Sovicille (SI) Italy
Bellaria, 35 I- 53010 Torri- Sovicille (SI) l- Italja
62 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
62 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
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 din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
63 PACKAGE LEAFLET:
63 FULJETT TA 'TAGĦRIF:
Helixate NexGen 500 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Helixate NexGen 500 IU trab u solvent għal soluzzjoni għall- injezzjoni Fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa)
What Helixate NexGen 500 IU is and what it is used for 2.
X' inhu Helixate NexGen 500 IU u għalxiex jintuża 2.
Before you use Helixate NexGen 500 IU 3.
Qabel ma tieħu Helixate NexGen 500 IU 3.
How to use Helixate NexGen 500 IU 4.
Kif għandek tieħu Helixate NexGen 500 IU 4.
How to store Helixate NexGen 500 IU 6.
Kif taħżen Helixate NexGen 500 IU 6.
WHAT Helixate NexGen 500 IU IS AND WHAT IT IS USED FOR
X' INHU Helixate NexGen 500 IU U GĦALXIEX JINTUŻA
One vial with powder for solution for injection nominally contains 500 IU octocog alfa (IU equals International Units).
Kunjett wieħed bit- trab għal soluzzjoni għall- injezzjoni li b' mod nominali fih 500 IU octocog alfa (IU tfisser Unitajiet Internazzjonali).
After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 200 IU/ ml.
Wara li jiġi rikostitwit bil- volum xieraq ta 'solvent (ilma għall - injezzjoni) kull kunjett ikun fih 200 IU/ ml octocog alfa.
BEFORE YOU USE Helixate NexGen 500 IU
QABEL MA TIEĦU Helixate NexGen 500 IU
Do not use Helixate NexGen 500 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of Helixate NexGen 500 IU.
Tużax Helixate NexGen 500 IU jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal octocog alfa, proteini tal- ġurdien jew għal proteini tal- ħemster jew għal xi wieħed mis- sustanzi l- oħra ta 'Helixate NexGen 500 IU.
Take special care with Helixate NexGen 500 IU as there is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction).
Oqgħod attent ħafna b' Helixate NexGen 500 IU billi hemm ċans rari li jista jkollok reazzjoni anafilattika (reazzjoni allerġika f' daqqa u serja).
If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing an allergic reaction to Helixate NexGen 500 IU.
Jekk int tħoss għafsa fis- sider, sturdamenti, tħossok dgħajjef jew ma tiflaħx, tħossok stordut waqt li int bil- wieqfa, jista 'jkun li qed tbati minn reazzjoni allerġika għal Helixate NexGen 500 IU.
Your doctor may wish to carry out tests to ensure that your current dose of Helixate NexGen 500 IU is sufficient to reach and maintain adequate factor VIII levels.
It- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jiżgura li d- doża attwali ta 'Helixate NexGen 500 IU hija biżżejjed biex tilħaq u żżomm livelli xierqa ta' Fattur VIII.
If your bleeding is not being controlled with Helixate NexGen 500 IU, consult your doctor immediately.
Jekk il- fsada tiegħek mhux qed tiġi kkontrollata b' Helixate NexGen 500 IU, ikkonsulta mat- tabib tiegħek minnufih.
64 If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.
64 Jekk qabel tkun żviluppajt inibitur ta ’ fattur VIII u taqleb il- prodotti ta ’ fattur VIII, tista ’ tkun f’ riskju li l- inibitur jerġa ’ jitfaċċa.
Pregnancy and breast-feeding Based on the rare occurrence of haemophilia A in women, experience regarding the use of Helixate NexGen 500 IU during pregnancy and breast-feeding is not available.
Tqala u Treddigħ Minħabba każijiet rari ta ’ emofilija A fin- nisa, l- esperjenza dwar l- użu ta ’ Helixate NexGen 500 IU fit- tqala u t- treddigħ m' hiex disponibbli.
Important information about some of the ingredients of Helixate NexGen 500 IU This medicinal product contain less than 1 mmol sodium (23 mg) per vial, i. e. essentially “ sodium- free”.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Helixate NexGen 500 IU Dan il- prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull kunjett, i. e essenzjalment huwa “ ħieles mis- sodju ”.
HOW TO USE Helixate NexGen 500 IU
KIF GĦANDEK TIEĦU Helixate NexGen 500 IU
Helixate NexGen 500 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
Helixate NexGen 500 IU huwa intiż għall- użu ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Use only the medical devices for reconstitution and administration provided with each package of Helixate NexGen 500 IU.
Uża biss it- tagħmir għar- rikostituzzjoni u l- għotja provduti fil- pakkett ta 'Helixate NexGen 500 IU.
Helixate NexGen 500 IU must not be mixed with other infusion solutions.
Helixate NexGen 500 IU m' għandux jiġi mħallat ma 'soluzzjonijiet oħra ta' l- infużjoni.
The amount of Helixate NexGen 500 IU you should use and how often you use it depends on many factors such as your weight, the severity of your haemophilia, the site and extent of bleeding, the amount of
Fl- aħħar, qiegħed ġbajra tal- pressjoni għal fuq il- ferita.
11 66 factor VIII inhibitors that you may have and the factor VIII level required.
11 66 L- ammont ta ’ Helixate NexGen 500 IU li għandek tuża jiddependi fuq ħafna fatturi bħal piż tal- ġisem, kemm hija severa l- emofilja, kemm hi kbira u minn fejn hi l- fsada, l- għadd ta ’ sustanzi inibituri tal - fattur VIII li jista ’ jkollok, u l- livell tal- fattur VIII meħtieġ.
Your doctor will calculate the dose of Helixate NexGen 500 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
It- tabib tiegħek ser jikkalkula d- doża ta ’ Helixate NexGen 500 IU u kemm- il darba trid tużah sabiex jkollok il- livell ta ’ l- attività meħtieġa tal- fattur VIII fid- demm tiegħek.
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.
Your doctor should always adapt the amount of Helixate NexGen 500 IU to be administered and the frequency of administration according to the clinical effectiveness in your individual case.
67 It- tabib tiegħek għandu dejjem jadatta l- ammont ta 'Helixate NexGen 500 IU li jiġi mogħti u l - frekwenza ta' l- għotja skond l- effettività klinika fil- każ tiegħek.
67 If you are using Helixate NexGen 500 IU to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Jekk qed tuża Helixate NexGen 500 IU biex tevita l- fsada (profilassi), it- tabib tiegħek ser jikkalkula d - doża għalik.
If you have the impression that the effect of Helixate NexGen 500 IU is too strong or too weak, talk to your doctor.
Jekk inti tal- fehma li l- effett ta 'Helixate NexGen 500 IU huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
Helixate NexGen 500 IU should be injected intravenously over several minutes.
Helixate NexGen għandu jingħata b’ injezzjoni ġol- vina fuq medda ta ’ numru ta ’ minuti.
Your doctor will tell you, how often and at what intervals Helixate NexGen 500 IU is to be administered.
It- tabib tiegħek għandu jgħidlek, kemm ta 'spiss u wara kemm Helixate NexGen 500 IU għandu jiġi meħud.
Usually, the substitution therapy with Helixate NexGen 500 IU is a life-time treatment.
Ġeneralment, it- terapija ta 'sostituzzjoni b' Helixate NexGen 500 IU huwa trattament tul il- ħajja kollha tal- pazjent.
If you use more Helixate NexGen 500 IU than you should:
Jekk tieħu aktar Helixate NexGen 500 IU milli suppost għandek:
If you have used more Helixate NexGen 500 IU than you should, please inform your doctor.
Jekk tuża aktar Helixate NexGen 500 IU milli għandek bżonn, għarraf it- tabib tiegħek.
If you forget to use Helixate NexGen 500 IU: • Proceed with the next administration immediately and continue at regular intervals as advised by your doctor. • Do not take a double dose to make up for a forgotten doses.
Jekk tinsa tieħu Helixate NexGen 500 IU: • Kompli bl- għotja li jmiss minnufih u ssokta f' intervalli regolari kif rakkomandat mit- tabib tiegħek • M' għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using Helixate NexGen 500 IU Do not stop using Helixate NexGen 500 IU without consulting your doctor.
Jekk tieqaf tieħu Helixate NexGen 500 IU Tieqafx tieħu Helixate NexGen 500 IU mingħajr ma tikkonsulta t- tabib tiegħek.
Like all medicines, Helixate NexGen 500 IU can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, Helixate NexGen 500 IU jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In rare cases, you may notice any of the following side effects after administration of Helixate NexGen 500 IU: • rash/ itchy rash, local reactions at the injection site (e. g. burning sensation, temporary redness) • hypersensitivity reactions (e. g. tightness of the chest/ general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing) • unusual taste in the mouth • fever.
F' każijiet rari, tista tinnota xi wieħed mill- effetti oħra li jista jkollu li ġejjin wara l- għotja ta 'Helixate NexGen 500 IU: • raxx/ ħakk tal- ġilda, reazzjonijiet fil post ta ’ l- injezzjoni (eż. ħruq, eritema temporanja) • reazzjonijiet ta' sensittività eċċessiva (eż. għafsa tas- sider/ tħossok ma tiflaħx, sturdament u dardir u pressjoni tad- demm kemmxejn baxxa, li tista 'tagħmlek dgħajjef waqt li tkun bil - wieqfa) • togħma mhux tas- soltu fil- ħalq • deni.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
69 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE Helixate NexGen 500 IU
KIF TAĦŻEN Helixate NexGen 500 IU
Do not use Helixate NexGen 500 IU after the expiry date which is stated on labels and cartons.
M' għandekx tuża Helixate NexGen 500 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l- kartun.
Do not use Helixate NexGen 500 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża Helixate NexGen 500 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
What Helixate NexGen 500 IU contains
X’ fih Helixate NexGen 500 IU
What Helixate NexGen 500 IU looks like and content of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Helixate NexGen 500 IU is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake.
Helixate NexGen 500 IU jiġi bħala trab u solvent għall- soluzzjoni għal injezzjoni u huwa trab xott jew kejk ta ’ lewn bajdani li jkanġi ftit fl- isfar.
Medical devices for reconstitution and administration are provided with each package of Helixate NexGen 500 IU.
Wara r- rikostituzzjoni s- soluzzjoni hija ċara. Tagħmir mediku għar- rikostituzzjoni u l- għoti jiġu ma ’ kull pakkett ta ’ Helixate NexGen 500 IU.
70 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
70 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
71 PACKAGE LEAFLET:
71 FULJETT TA 'TAGĦRIF:
Helixate NexGen 1000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Helixate NexGen 1000 IU trab u solvent għal soluzzjoni għall- injezzjoni Fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa)
What Helixate NexGen 1000 IU is and what it is used for 2.
X' inhu Helixate NexGen 1000 IU u għalxiex jintuża 2.
Before you use Helixate NexGen 1000 IU 3.
Qabel ma tieħu Helixate NexGen 1000 IU 3.
How to use Helixate NexGen 1000 IU 4.
Kif għandek tieħu Helixate NexGen 1000 IU 4.
How to store Helixate NexGen 1000 IU 6.
Kif taħżen Helixate NexGen 1000 IU 6.
WHAT Helixate NexGen 1000 IU IS AND WHAT IT IS USED FOR
X' INHU Helixate NexGen 1000 IU U GĦALXIEX JINTUŻA
One vial with powder for solution for injection nominally contains 1000 IU octocog alfa (IU equals International Units).
Kunjett wieħed bit- trab għal soluzzjoni għall- injezzjoni li b' mod nominali fih 1000 IU octocog alfa (IU tfisser Unitajiet Internazzjonali).
After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 400 IU/ ml.
Wara li jiġi rikostitwit bil- volum xieraq ta 'solvent (ilma għall - injezzjoni) kull kunjett ikun fih 400 IU/ ml octocog alfa.
BEFORE YOU USE Helixate NexGen 1000 IU
QABEL MA TIEĦU Helixate NexGen 1000 IU
Do not use Helixate NexGen 1000 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of Helixate NexGen 1000 IU.
Tużax Helixate NexGen 1000 IU jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal octocog alfa, proteini tal- ġurdien jew għal proteini tal- ħemster jew għal xi wieħed mis- sustanzi l- oħra ta 'Helixate NexGen 1000 IU.
Take special care with Helixate NexGen 1000 IU as there is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction).
Oqgħod attent ħafna b' Helixate NexGen 1000 IU billi hemm ċans rari li jista jkollok reazzjoni anafilattika (reazzjoni allerġika f' daqqa u serja).
If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing an allergic reaction to Helixate NexGen 1000 IU.
Jekk int tħoss għafsa fis- sider, sturdamenti, tħossok dgħajjef jew ma tiflaħx, tħossok stordut waqt li int bil- wieqfa, jista 'jkun li qed tbati minn reazzjoni allerġika għal Helixate NexGen 1000 IU.
Your doctor may wish to carry out tests to ensure that your current dose of Helixate NexGen 1000 IU is sufficient to reach and maintain adequate factor VIII levels.
It- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jiżgura li d- doża attwali ta 'Helixate NexGen 1000 IU hija biżżejjed biex tilħaq u żżomm livelli xierqa ta' Fattur VIII.
If your bleeding is not being controlled with Helixate NexGen 1000 IU, consult your doctor immediately.
Jekk il- fsada tiegħek mhux qed tiġi kkontrollata b' Helixate NexGen 1000 IU, ikkonsulta mat- tabib tiegħek minnufih.
72 If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.
72 Jekk qabel tkun żviluppajt inibitur ta ’ fattur VIII u taqleb il- prodotti ta ’ fattur VIII, tista ’ tkun f’ riskju li l- inibitur jerġa ’ jitfaċċa.
Pregnancy and breast-feeding Based on the rare occurrence of haemophilia A in women, experience regarding the use of Helixate NexGen 1000 IU during pregnancy and breast-feeding is not available.
Tqala u Treddigħ Minħabba każijiet rari ta ’ emofilija A fin- nisa, l- esperjenza dwar l- użu ta ’ Helixate NexGen 1000 IU fit- tqala u t- treddigħ m' hiex disponibbli.
Important information about some of the ingredients of Helixate NexGen 1000 IU This medicinal product contain less than 1 mmol sodium (23 mg) per vial, i. e. essentially “ sodium- free”.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Helixate NexGen 1000 IU Dan il- prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull kunjett, i. e essenzjalment huwa “ ħieles mis- sodju ”.
HOW TO USE Helixate NexGen 1000 IU
KIF GĦANDEK TIEĦU Helixate NexGen 1000 IU
Helixate NexGen 1000 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
Helixate NexGen 1000 IU huwa intiż għall- użu ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Use only the medical devices for reconstitution and administration provided with each package of Helixate NexGen 1000 IU.
Uża biss it- tagħmir għar- rikostituzzjoni u l- għotja provduti fil- pakkett ta 'Helixate NexGen 1000 IU.
Helixate NexGen 1000 IU must not be mixed with other infusion solutions.
Helixate NexGen 1000 IU m' għandux jiġi mħallat ma 'soluzzjonijiet oħra ta' l- infużjoni.
The amount of Helixate NexGen 1000 IU you should use and how often you use it depends on many factors such as your weight, the severity of your haemophilia, the site and extent of bleeding, the
Fl- aħħar, qiegħed ġbajra tal- pressjoni għal fuq il- ferita.
11 74 amount of factor VIII inhibitors that you may have and the factor VIII level required.
11 74 L- ammont ta ’ Helixate NexGen 1000 IU li għandek tuża jiddependi fuq ħafna fatturi bħal piż tal - ġisem, kemm hija severa l- emofilja, kemm hi kbira u minn fejn hi l- fsada, l- għadd ta ’ sustanzi inibituri tal- fattur VIII li jista ’ jkollok, u l- livell tal- fattur VIII meħtieġ.
Your doctor will calculate the dose of Helixate NexGen 1000 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
It- tabib tiegħek ser jikkalkula d- doża ta ’ Helixate NexGen 1000 IU u kemm- il darba trid tużah sabiex jkollok il- livell ta ’ l- attività meħtieġa tal- fattur VIII fid- demm tiegħek.
Your doctor should always adapt the amount of Helixate NexGen 1000 IU to be administered and the frequency of administration according to the clinical effectiveness in your individual case.
75 It- tabib tiegħek għandu dejjem jadatta l- ammont ta 'Helixate NexGen 1000 IU li jiġi mogħti u l - frekwenza ta' l- għotja skond l- effettività klinika fil- każ tiegħek.
75 If you are using Helixate NexGen 1000 IU to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Jekk qed tuża Helixate NexGen 1000 IU biex tevita l- fsada (profilassi), it- tabib tiegħek ser jikkalkula d- doża għalik.
If you have the impression that the effect of Helixate NexGen 1000 IU is too strong or too weak, talk to your doctor.
Jekk inti tal- fehma li l- effett ta 'Helixate NexGen 1000 IU huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
Helixate NexGen 1000 IU should be injected intravenously over several minutes.
Helixate NexGen għandu jingħata b’ injezzjoni ġol- vina fuq medda ta ’ numru ta ’ minuti.
Your doctor will tell you, how often and at what intervals Helixate NexGen 1000 IU is to be administered.
It- tabib tiegħek għandu jgħidlek, kemm ta 'spiss u wara kemm Helixate NexGen 1000 IU għandu jiġi meħud.
Usually, the substitution therapy with Helixate NexGen 1000 IU is a life-time treatment.
Ġeneralment, it- terapija ta 'sostituzzjoni b' Helixate NexGen 1000 IU huwa trattament tul il- ħajja kollha tal- pazjent.
If you use more Helixate NexGen 1000 IU than you should:
Jekk tieħu aktar Helixate NexGen 1000 IU milli suppost għandek:
If you have used more Helixate NexGen 1000 IU than you should, please inform your doctor.
Jekk tuża aktar Helixate NexGen 1000 IU milli għandek bżonn, għarraf it- tabib tiegħek.
If you forget to use Helixate NexGen 1000 IU: • Proceed with the next administration immediately and continue at regular intervals as advised by your doctor. • Do not take a double dose to make up for a forgotten doses.
Jekk tinsa tieħu Helixate NexGen 1000 IU: • Kompli bl- għotja li jmiss minnufih u ssokta f' intervalli regolari kif rakkomandat mit- tabib tiegħek • M' għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using Helixate NexGen 1000 IU Do not stop using Helixate NexGen 1000 IU without consulting your doctor.
Jekk tieqaf tieħu Helixate NexGen 1000 IU Tieqafx tieħu Helixate NexGen 1000 IU mingħajr ma tikkonsulta t- tabib tiegħek.
Like all medicines, Helixate NexGen 1000 IU can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, Helixate NexGen 1000 IU jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In rare cases, you may notice any of the following side effects after administration of Helixate NexGen 1000 IU: • rash/ itchy rash, local reactions at the injection site (e. g. burning sensation, temporary redness) • hypersensitivity reactions (e. g. tightness of the chest/ general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing) • unusual taste in the mouth • fever.
F' każijiet rari, tista tinnota xi wieħed mill- effetti oħra li jista jkollu li ġejjin wara l- għotja ta 'Helixate NexGen 1000 IU: • raxx/ ħakk tal- ġilda, reazzjonijiet fil post ta ’ l- injezzjoni (eż. ħruq, eritema temporanja) • reazzjonijiet ta' sensittività eċċessiva (eż. għafsa tas- sider/ tħossok ma tiflaħx, sturdament u dardir u pressjoni tad- demm kemmxejn baxxa, li tista 'tagħmlek dgħajjef waqt li tkun bil - wieqfa) • togħma mhux tas- soltu fil- ħalq • deni.