qanastek/EMEA-V3 huggingface dataset:
NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: • in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda Units (BU) • in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration • in patients with acquired haemophilia • in patients with congenital FVII deficiency • in patients with Glanzmann ’ s thrombasthenia with antibodies to GP IIb - IIIa and/ or HLA, and with past or present refractoriness to platelet transfusions.
NovoSeven huwa indikat għall- kura ta ’ episodji ta ’ emorraġija u għall- prevenzjoni ta ’ l- emorraġija f’ dawk li tkun qed issirilhom operazzjoni jew proċeduri invażivi fil- gruppi ta ’ pazjenti li ġejjin • f’ pazjenti li għandhom emofilja konġenitali b’ inibituri għall- fatturi VIII jew IX tal - koagulazzjoni > 5 Unitjiet Bethesda (UB) • f’ pazjenti li għandhom emofilja konġenitali u li huwa mistenni li jkollhom rispons anamnestiku qawwi għall- għoti tal- fattur VIII jew tal- fattur IX • f’ pazjenti li għandhom emofilja akkwiżita • f’ pazjenti li għandhom nuqqas konġenitali ta ’ FVII • f’ pazjenti li għandhom trombastenja ta ’ Glanzmann b’ antikorpi għal GP IIb- IIIa u/ jew HLA, u b’ reżistenza fil- passat jew fil- preżent għal trasfużjonijiet tal- plejtlets.
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/ or bleeding disorders.
Il- kura għandha tinbeda taħt is- superviżjoni ta 'tabib b' esperjenza fil- kura ta' l- emofilja u/ jew disturbi emorraġiċi.
Haemophilia A or B with inhibitors or expected to have a high anamnestic response
Emofilja A jew B bl- inibituri jew mistennija li jkollhom rispons anamnestiku għoli
Dose NovoSeven should be given as early as possible after the start of a bleeding episode.
Doża NovoSeven għandu jingħata malajr kemm jista ’ jkun wara li jkun beda episodju ta ’ emorraġija.
The recommended initial dose, administered by intravenous bolus injection, is 90 μ g per kg body weight.
Huwa rakkomandat li l- ewwel doża, mogħtija b’ injezzjoni bolus minn ġol- vini, tkun ta ’ 90 µg għal kull kilogramm ta ’ piż tal- ġisem.
Following the initial dose of NovoSeven further injections may be repeated.
2 Wara l- ewwel doża ta ’ NovoSeven, jistgħu jiġu ripetuti iżjed injezzjonijiet.
The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive procedures or surgery being performed.
Kemm iddum il- kura u l - intervall bejn l- injezzjonijiet ivarjaw skond is- severità ta ’ l- emorraġija, il- proċeduri invażivi jew l - operazzjoni li tkun qed isseħħ.
2 Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.
Dożaġġ fit- tfal S’ issa l- esperjenza klinika ma turix li hemm il- bżonn ta ’ dożaġġ differenti ħafna bejn dik tat- tfal u dik ta ’ l- adulti, għalkemm it- tneħħja fit- tfal tkun aktar mgħaġġla milli fl- adulti.
Therefore, higher doses of rFVIIa may be needed in paediatric patients to achieve similar plasma concentrations as in adult patients (see section 5.2).
Għalhekk, sabiex jintlaħqu konċentrazzjonijiet fil- plażma simili għal dawk f’ pazjenti adulti, jista ’ jkun hemm il- bżonn ta ’ dożi ogħla ta ’ rFVIIa f’ pazjenti pedjatriċi (ara sezzjoni 5. 2).
Dose interval Initially 2 - 3 hours to obtain haemostasis.
Intervall bejn doża u oħra Fil- bidu, kull sagħtejn jew tliet sigħat biex tikseb emostasi.
If continued therapy is needed, the dose interval can be increased successively once effective haemostasis is achieved to every 4, 6, 8, or 12 hours for as long as treatment is judged as being indicated.
Jekk ikun hemm il- bżonn li t- terapija titkompla, ladarba tintlaħaq l- emostasi l- intervall bejn doża u oħra jista ’ jiżdied progressivament għal kull 4, 6, 8, jew 12- il siegħa sakemm il- kura tkun meqjusa li hija indikata.
Mild to moderate bleeding episodes (including home therapy)
Episodji emorraġiċi ħfief għal moderati (inkluża l- kura d- dar)
Early intervention has been shown to be efficacious in the treatment of mild to moderate joint, muscle and mucocutaneous bleeds.
Ġie muri li intervent bikri kien effikaċi fil- kura ta ’ emorraġiji ħfief għal moderati tal- ġogi, tal- muskoli u mukokutanji.
Two dosing regimens can be recommended:
Żewġ skedi ta ’ dożaġġ jistgħu jiġu rakkomandati:
1) Two to three injections of 90 µg per kg body weight administered at three-hour intervals If further treatment is required, one additional dose of 90 µg per kg body weight can be administered 2) One single injection of 270 µg per kg body weight
Jekk ikun hemm il- bżonn li l- kura titkompla, doża oħra ta ’ 90 µg għal kull kg ta ’ piż tal- ġisem tista ’ tiġi mgħotija.
The duration of the home therapy should not exceed 24 hours.
Il- perijodu tal- kura d- dar m’ għandux jaqbeż l- 24 siegħa.
There is no clinical experience with administration of a single dose of 270 µg per kg body weight in elderly patients.
M' hemmx esperjenza klinika fit- teħid ta 'doża waħda ta' 270 µg għal kull kg ta 'piż tal- ġisem f' pazjenti anzjani.
Serious bleeding episodes An initial dose of 90 µg per kg body weight is recommended and could be administered on the way to the hospital where the patient is usually treated.
Episodji emorraġiċi serji Huwa rakkomandat li l- ewwel doża għandha tkun ta ’ 90 µg għal kull kilogramm ta ’ piż tal- ġisem u tista ’ tingħata fit- triq lejn l- isptar fejn normalment jiġi kkurat il- pazjent.
The following dose varies according to the type and severity of the haemorrhage.
Id- doża sussegwenti tvarja skond it- tip u s- severità ta ’ l- emorraġija.
Dosing frequency should initially be every second hour until clinical improvement is observed.
Fil- bidu, l- intervall bejn doża u oħra għandu jkun ta ’ sagħtejn sakemm jiġi osservat titjib kliniku.
If continued therapy is indicated, the dose interval can then be increased to 3 hours for 1 - 2 days.
Jekk ikun hemm il- bżonn li t- terapija titkompla, l - intervall bejn id- dożi jista ’ jiżdied għal 3 sigħat għal ġurnata sa jumejn.
Thereafter, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged as being indicated.
Wara dan, l- intervall bejn id - dożi jista ’ jiżdied progressivament għal kull 4, 6, 8, jew 12- il siegħa sakemm il- kura tkun meqjusa li hija indikata.
A major bleeding episode may be treated for 2 - 3 weeks but can be extended beyond this if clinically warranted.
Episodju ta ’ emorraġija maġġuri jista ’ jiġi kkurat minn ġimagħtejn sa tlieta iżda jista ’ jiġi estiż għal aktar minn hekk jekk ikun klinikament meħtieġ.
Invasive procedure/ surgery An initial dose of 90 µg per kg body weight should be given immediately before the intervention.
Operazzjoni/ proċedura invażiva L- ewwel doża li tingħata immedjatament qabel l- intervent għandha tkun ta ’ 90 µg għal kull kilogramm ta ’ piż tal- ġisem.
The dose should be repeated after 2 hours and then at 2 - 3 hour intervals for the first 24 - 48 hours depending on the intervention performed and the clinical status of the patient.
Id- doża għandha tiġi ripetuta wara sagħtejn u mbagħad bejn kull sagħtejn u tliet sigħat għall- ewwel 24- 48 siegħa, skond l- intervent li jkun sar u l- istat kliniku tal- pazjent.
In major surgery, the dose should be continued at 2 - 4 hour intervals for 6 - 7 days.
F’ operazzjoni maġġuri, id- doża għandha titkompla bejn kull sagħtejn u 4 sigħat għal 6 - 7 ijiem.
The dose interval may then be increased to 6 - 8 hours for another 2 weeks of treatment.
L - intervall bejn doża u oħra jista ’ mbagħad jiżdied għal 6 - 8 sigħat għal ġimagħtejn oħra ta ’ kura.
Patients undergoing major surgery may be treated for up to 2 - 3 weeks until healing has occurred.
Il - pazjenti li jkunu għaddejjin minn operazzjoni maġġuri jistgħu jiġu kkurati għal perijodu ta’ ġimgħatejn sa 3 ġimgħat sakemm ikunu fiequ kompletament.
Acquired Haemophilia
Emofilja akkwiżita
Dose and dose interval NovoSeven should be given as early as possible after the start of a bleeding episode.
Doża u intervall bejn doża u oħra
The recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight.
3 NovoSeven għandu jingħata kmienu kemm jista ’ jkun wara li jkun beda episodju ta ’ emorraġija. Huwa rakkomandat li l- ewwel doża, mgħotija permezz ta ’ injezzjoni bolus minn ġol- vini, tkun ta ’ 90 µg għal kull kg ta ’ piż tal- ġisem.
Following the initial dose of NovoSeven further injections may be given if required.
Wara l- ewwel doża ta ’ NovoSeven, jekk ikun hemm bżonn jistgħu jingħataw iżjed injezzjonijiet.
The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive procedures or the surgery being performed.
Kemm iddum il- kura u l- intervall bejn injezzjoni u oħra jiddependu mis- severità ta ’ l- emorraġija, mill- proċeduri invażivi jew mill- operazzjoni li tkun għaddejja.
Once haemostasis has been achieved, the dose interval can be increased successively to every 4, 6, 8, or 12 hours for as long as treatment is judged to be indicated.
L- ewwel intervall bejn doża u oħra għandu jkun ta ’ 2- 3 sigħat. Ladarba jkun intlaħaq l- emostasi, l - intervall bejn doża u oħra jista ’ jiżdied progressivament għal kull 4, 6, 8, jew 12- il siegħa sakemm il - kura tkun meqjusa li hija indikata.
Factor VII deficiency
Pazjenti neqsin mill- Fattur VII
3 Dose, dose range and dose interval The recommended dose range for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 15 - 30 μ g per kg body weight every 4 - 6 hours until haemostasis is achieved.
Il- limiti rakkomandati tad- doża għall- kura ta ’ episodji ta ’ emorraġija f’ pazjenti li fuqhom saret operazzjoni jew proċeduri invażivi huma ta ’ 15- 30 µg għal kull kilogramm ta ’ piż tal- ġisem kull 4 sa 6 sigħat sakemm tintlaħaq l- emostasi.
Dose and frequency of injections should be adapted to each individual.
Id- doża u l- frekwenza ta ’ l- injezzjonijiet għandhom jiġu adattati għal kull individwu.
Glanzmann’ s thrombasthenia
Trombastenja ta ‘ Glanzmann
Dose, dose range and dose interval The recommended dose for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 90 µg (range 80 - 120 µg) per kg body weight at intervals of two hours (1.5 - 2.5 hours).
Id- doża rakkomandata għall- kura ta ’ episodji ta ’ emorraġija u għall- prevenzjoni ta ’ l- emorraġija f’ pazjenti li għaddejjin minn operazzjoni jew proċeduri invażivi hi ta ’ 90 µg (limiti fid- doża ta ’ 80 - 120 µg) għal kull kilogramm ta ’ piż tal- ġisem f’ intervalli ta ’ sagħtejn (1. 5 - 2. 5 sigħat).
At least three doses should be administered to secure effective haemostasis.
Għandhom jingħataw mill- inqas tliet dożi biex tiġi aċċertata emostasi li tkun effettiva.
The recommended route of administration is bolus injection as lack of efficacy may appear in connection with continuous infusion.
Il- mod rakkomandat ta ’ kif għandu jingħata hu permezz ta ’ injezzjoni bolus minħabba li tista ’ tidher xi nuqqas ta ’ effikaċja b’ rabta ma ’ l- infużjoni kontinwa.
For those patients who are not refractory, platelets are the first line treatment for Glanzmann’ s thrombasthenia.
Il- plejtlets huma l- kura primarja għat- trombastenja ta ’ Glanzmann, f’ dawk il- pazjenti li m’ humiex reżistenti għal din il- kura
Method of administration
Metodu ta 'kif jingħata
Reconstitute the solution as described under section 6.6 and administer as an intravenous bolus injection over 2 - 5 minutes.
Irrikostitwixxi s- soluzzjoni kif deskritt taħt sezzjoni 6. 6 u agħti bħala injezzjoni bolus minn ġol- vini fuq perijodu ta ’ 2 - 5 minuti.
Monitoring of treatment – Laboratory Tests
Monitoraġġ tal- kura – Testijiet fil- Laboratorji
There is no requirement for monitoring of NovoSeven therapy.
M’ hemmx bżonn ta ’ monitoraġġ tat- terapija b’ NovoSeven.
Severity of bleeding condition and clinical response to NovoSeven administration must guide dosing requirements.
Is- severità tal- kundizzjoni ta ’ l- emorraġija u r- rispons kliniku għall- għoti ta ’ NovoSeven għandhom jiggwidaw il- ħtiġijiet tad- doża.
After administration of NovoSeven, prothrombin time (PT) and activated partial thromboplastin time (aPTT) have been shown to shorten, however no correlation has been demonstrated between PT and aPTT and clinical efficacy of NovoSeven.
Wara l- għoti ta ’ NovoSeven, l- prothrombin time (PT) u l- activated partial thromboplastin time (aPTT) kienu osservati li qsaru, iżda ma ntweriet l- ebda korrelazzjoni bejn il- PT u l- aPTT u l - effikaċja klinika ta ’ NovoSeven.
Hypersensitivity to the active substance, or to any of the excipients, or to mouse, hamster or bovine protein.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi, jew għall- proteini tal - ġrieden, tal- ħamster jew tal- bovini.
In pathological conditions in which tissue factor may be expressed more extensively than considered normal, there may be a potential risk of development of thrombotic events or induction of Disseminated Intravascular Coagulation (DIC) in association with NovoSeven treatment.
F’ kundizzjonijiet patoloġiċi li fihom il- fattur tat- tessut jista ’ jiġi espress b’ mod aktar estensiv minn dak li huwa kkunsidrat bħala normali, jista ’ jkun hemm riskju potenzjali ta ’ l- iżvilupp ta ’ avvenimenti
Such situations may include patients with advanced atherosclerotic disease, crush injury, septicaemia or DIC.
Dawn is- sitwazzjonijiet jistgħu jinkludu pazjenti b’ mard aterosklerotiku avvanzat, leżjonijiet minħabba tgħaffiġ, settiċemija jew DIC.
Because of the risk of thromboembolic complications, caution should be excercised when administering NovoSeven to patients with a history of coronary heart disease, to patients with liver disease, to patients post-operatively, to neonates, or to patients at risk of thromboembolic phenomena or disseminated intravascular coagulation.
Minħabba r- riskju ta 'komplikazzjonijiet trombo- emboliċi, għandha tittieħed kawtela meta NovoSeven jingħata lil pazjenti b' passat ta' mard tal- qalb koronarju, lil pazjenti b' mard tal- fwied, lil pazjenti wara operazzjoni, lit- trabi li għadhom kif jitwieldu, jew lil pazjenti b' riskju ta 'fenomini trombo- emboliċi jew koagulazzjoni intravaskulari mifruxa.
In each of these situations, the potential benefit of treatment with NovoSeven should be weighed against the risk of these complications.
F' kull waħda minn dawn is- sitwazzjonijiet, il- benefiċċju potenzjali tal- kura b' NovoSeven għandha tiġi mwieżna kontra r- riskji ta 'dawn il- komplikazzjonijiet.
As recombinant coagulation factor NovoSeven may contain trace amounts of mouse IgG, bovine IgG and other residual culture proteins (hamster and bovine serum proteins), the remote possibility exists that patients treated with the product may develop hypersensitivity to these proteins.
Peress li NovoSeven, bħala fattur tal- koagulazzjoni rikombinanti jista ’ jkun fih traċċi ta ’ IgG tal - ġrieden, IgG tal- bovini u proteini residwi oħrajn ta’ kultura (proteini tas- serum tal- ħamster u tal - bovini), teżisti l- possibbilità remota li l- pazjenti kkurati bil- prodott jistgħu jiżviluppaw sensittività eċċessiva għal dawn il- proteini.
In such cases treatment with antihistamines i. v. should be considered.
F' dawn il- każi għandha tiġi kkunsidrata l- kura b' antistamini i. v.
If allergic or anaphylactic-type reactions occur, the administration should be discontinued immediately.
Jekk iseħħu reazzjonijiet allerġiċi jew tat- tip anafilattiku, it- teħid għandu jitwaqqaf minnufih.
In case of shock, standard medical treatment for shock should be implemented.
F' każ ta 'xokk, għandha tiġi implimentata l- kura medika normali għal xokk.
If such symptoms occur, the
Il- pazjenti għandhom jiġu infurmati x' inhuma s- sinjali bikrija ta 'reazzjonijiet ta' sensittività eċċessiva.
4 patient should be advised to discontinue use of the product immediately and contact their physician.
Jekk iseħħu dawn is - sintomi, il- pazjenti għandhom jingħataw il- parir li jwaqqfu l- użu tal- prodott minnufih u jkellmu lit - tabib tagħhom.
In case of severe bleeds the product should be administered in hospitals preferably specialized in treatment of haemophilia patients with coagulation factor VIII or IX inhibitors, or if not possible in close collaboration with a physician specialized in haemophilia treatment.
F’ każ ta ’ emorraġiji severi, il- prodott għandu jingħata fl- isptarijiet li jkunu preferibbilment speċjalizzati fil- kura ta ’ pazjenti bl- emofilja b’ inibituri għall- fatturi VIII jew IX tal- koagulazzjoni, jew jekk mhux possibbli, b’ kollaborazzjoni mill- qrib ma ’ tabib speċjalizzat fil- kura ta ’ l- emofilja.
If bleeding is not kept under control hospital care is mandatory.
Jekk l- emorraġija ma tkunx ikkontrollata, il- kura fl- isptar hi mandatorja.
Patients/ carers should inform the physician/ supervising hospital at the earliest possible opportunity about all usages of NovoSeven.
Ma ’ l- ewwel opportunità possibbli, il- pazjenti/ carers għandhom jinfurmaw lit- tabib/ l- isptar sorveljanti dwar kif ġie użat NovoSeven.
Factor VII deficient patients should be monitored for prothrombin time and factor VII coagulant activity before and after administration of NovoSeven.
Pazjenti li huma nieqsa mill- fattur VII għandhom jiġu mmonitorjati għall- prothrombin time u l - attività koagulanti tal- fattur VII qabel u wara l- għoti ta ’ NovoSeven.
In case the factor VIIa activity fails to reach the expected level or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed.
Jekk l- attività tal- fattur VIIa ma tilħaqx il- livell mistenni jew jekk wara l- kura bid- dożi rakkomandati l- emorraġija ma tkunx ikkontrollata, tista ’ tissuspetta l- formazzjoni ta ’ l- antikorpi u għandha ssir analiżi għall- antikorpi.
The risk of thrombosis in factor VII deficient patients treated with NovoSeven is unknown.
Ir - riskju ta ’ trombożi f’ pazjenti b’ nuqqas tal- Fattur VII ikkurati b’ NovoSeven m’ huwiex magħruf.
The risk of a potential interaction between NovoSeven and coagulation factor concentrates is unknown.
Ir- riskju ta ’ xi interazzjoni potenzjali bejn NovoSeven u l- konċentrati ta ’ fatturi tal- koagulazzjoni m’ huwiex magħruf.
Simultaneous use of prothrombin complex concentrates, activated or not, should be avoided.
L- użu fl- istess ħin ta ’ konċentrati tal- kumpless ta ’ prothrombin, attivati jew le, għandu jiġi evitat.
Anti-fibrinolytics have been reported to reduce blood loss in association with surgery in haemophilia patients, especially in orthopaedic surgery and surgery in regions rich in fibrinolytic activity, such as the oral cavity.
Sustanzi anti- fibrinolitiċi ġew irrappurtati li jnaqqsu l- ammont ta ’ demm li jintilef assoċjat ma ’ l - operazzjonijiet f’ pazjenti bl- emofilja, speċjalment f’ operazzjonijiet ta ’ l- ortopedija u f’ operazzjonijiet fejn ikun hemm ħafna attività fibrinolitika, bħall- kavità orali.
Experience with concomitant administration of anti-fibrinolytics and NovoSeven treatment is however limited.
Madankollu, l- esperjenza bl- għoti fl - istess ħin ta ’ sustanzi anti- fibrinolitiċi u l- kura b’ NovoSeven, hi limitata.
As a precautionary measure, it is preferable to avoid use of NovoSeven during pregnancy.
Bħala miżura ta 'prekawzjoni, huwa preferibbli li jiġi evitat l- użu ta' NovoSeven waqt it- tqala.
Data on a limited number of exposed pregnancies within approved indications indicate no adverse effects of rFVIIa on pregnancy or on the health of the foetus/ new-born child.
Sa llum, m’ hemm l- ebda
To date, no other relevant epidemiological data are available.
5 tagħrif epidemjoloġiku relevanti ieħor.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta 'l- embriju/ fetu, ħlas jew żvilupp wara t- twelid (ara 5. 3).
Use during lactation:
L- użu waqt it- treddigħ:
It is not known whether rFVIIa is excreted in human milk.
M’ huwiex magħruf jekk rFVIIa jitneħħiex fil- ħalib tal- bniedem.
No effects on the breastfed newborn/ infant are anticipated.
Mhux mistennija li jkun hemm effetti fuq it- tarbija tat- twelid/ tarbija li qed tredda '.
NovoSeven can be used during breast-feeding.
NovoSeven jista 'jintuża waqt it- treddigħ.
No studies on the effect on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq u tħaddem magni.
Based on post-marketing experience adverse drug reactions are rare (< 1 per 1,000 standard doses).
Fuq bażi ta ’ l- esperjenza wara t- tqegħid fis- suq, ir- reazzjonijiet avversi għall- mediċina huma rari (< 1 għal kull 1, 000 doża standard).
When analysed by system organ classes, the reporting rates of adverse drug reactions during the post- marketing period, including both serious and non-serious reactions, are as indicated in the table below:
Meta analizzati skond is- sistema tal- klassifika ta ’ l- organi, ir- rati tar - rapporti ta ’ reazzjonijiet avversi għall- mediċina matul il- perijodu wara t- tqegħid fis- suq, li jinkludu kemm reazzjonijiet serji kif ukoll dawk mhux serji, huma kif indikat fit- tabella hawn taħt:
Blood and lymphatic disorders Very rare (< 1/ 10,000)
Disturbi tad- demm u tas- sistema limfatika
Few cases of coagulopathic disorders such as increased D-dimer and consumptive coagulopathy have been reported.
Rari ħafna (< 1/ 10, 000)
Patients at increased risk of disseminated intravascular coagulation as described in section 4.4 should be carefully monitored.
Il- pazjenti b’ riskju ogħla ta ’ koagulazzjoni intravaskulari disseminata kif deskritt f’ sezzjoni 4. 4 għandhom jiġu mmonitorjati b’ attenzjoni.
Cardiac disorders
Rari ħafna (< 1/ 10, 000)
Myocardial infarction:
Infart tal- qalb:
Described below under ‘ serious adverse reactions
Deskritt hawn taħt bħala ‘ reazzjonijiet avversi serji rrapportati matul il- perijodu ta ’ wara t- tqegħid fis- suq ’.
5 reported during the post-marketing period ’.
Disturbi gastro- intestinali
Gastrointestinal disorders Very rare (< 1/ 10,000)
Rari ħafna (< 1/ 10, 000)
Nausea.
Tqalligħ.
General disorders and administration site conditions Rare (> 1/ 10,000, < 1/ 1,000)
Rari (> 1/ 10, 000 < 1/ 1, 000)
Lack of efficacy (therapeutic response decreased) has been reported.
Ġie rrapportat nuqqas ta ’ effikaċja (tnaqqis fir- rispons terapewtiku).
It is important that the dosage regimen of NovoSeven is compliant with the recommended dosage as stated in section 4.2.
Huwa importanti li l- iskeda ta ’ dożaġġ ta ’ NovoSeven ikun konformi mad- dożaġġ rakkomandat li hemm dikjarat f’ sezzjoni 4. 2.
Fever may occur.
Jista ’ jitla ’ d- deni.
Pain, especially at injection site may also occur on rare occasions.
F’ każijiet rari jista ’ jkun hemm ukoll uġigħ, speċjalment fil- post ta ’ l- injezzjoni.
Increase of alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and prothrombin levels have been reported.
Ġew irrapportati żieda fl- alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase u fil- livelli tal- prothrombin.
Nervous system disorders Very rare (< 1/ 10,000)
6 Rari ħafna (< 1/ 10, 000)
Cerebrovascular disorders including cerebral infarction and cerebral ischaemia have been reported:
Ġew irrapportati disturbi ċerebrovaskulari inkluż infart ċerebrali u iskemija ċerebrali:
Described below under ’ serious adverse reactions reported during the post-marketing period’.
Deskritti hawn taħt bħala ‘ reazzjonijiet avversi serji rrapportati matul il- perijodu ta ’ wara t- tqegħid fis- suq ’.
Skin rashes may occur.
Disturbi fil- ġilda u fit- tessut ta ’ taħt il- ġilda
Vascular disorders
Rari ħafna (< 1/ 10, 000)
Venous thrombotic events have been reported:
Ġew irrapportati avvenimenti trombotiċi fil- vini:
Described below under ’ serious adverse reactions reported during the post-marketing period ’ Incidents of haemorrhage have been reported.
Ġew irrapportati inċidenti ta ’ emorraġija.
NovoSeven is not expected to precipitate haemorrhage, but pre-existing haemorrhage may continue in case of insufficient efficacy or sub-optimal dosage regimen.
NovoSeven mhux mistenni li jikkawża l- emorraġija, iżda l- emorraġija li tkun hemm minn qabel tista ’ tkompli fil- każ ta ’ nuqqas ta ’ effikaċja jew skeda ta ’ dożaġġ li ma jkunx l - aħjar wieħed.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Reazzjonijiet avversi serji li ġew irrappurtati matul il- perijodu ta ’ wara t- tqegħid fis- suq jinkludu:
Serious adverse reactions reported during the post-marketing period include: – Arterial thrombotic events such as myocardial infarctions or ischaemia, cerebrovascular disorders and bowel infarction.
- Avvenimenti trombotiċi fl- arterji, bħal infart tal- qalb jew iskemija, disturbi ċerebrovaskulari, u
In the vast majority of cases the patients were predisposed to arterial thrombotic disorders either due to underlying disease, age, atherosclerotic or current medical conditions as described in section 4.4 – Venous thrombotic events such as thrombophlebitis, deep vein thrombosis and hereto related pulmonary embolism.
Kważi fil- każijiet kollha, l- pazjenti kienu predisposti għal disturbi trombotiċi fl- arterji minħabba li kien hemm xi mard ieħor l- età, kundizzjonijiet aterosklerotiċi jew kundizzjonijiet medikali oħrajn kurrenti kif deskritt f’ sezzjoni 4. 4
In the vast majority of cases the patients were predisposed to venous thrombotic events due to concurrent risk factors.
- Avvenimenti trombotiċi fil- vini bħal tromboflebite, trombożi tal- vini fil- fond u b’ konsegwenza
Patients at increased risk of venous thrombotic disorders either due to concurrent conditions, previous history of thrombotic events, post surgery immobilisation or venous catheterisation should be carefully monitored – Thrombotic events of the liver.
Kważi fil- każijiet kollha, il- pazjenti kienu predisposti għal disturbi trombotiċi fil- vini minħabba fatturi ta ’ riskju li jkunu jeżistu fl- istess ħin.
In the vast majority of cases the patients were predisposed due to liver disease or liver surgery.
Il- pazjenti b’ riskju ogħla ta ’ disturbi trombotiċi fil- vini minħabba kundizzjonijiet li jkunu jeżistu fl- istess ħin, passat mediku ta ’ avvenimenti trombotiċi, immobilizzazzjoni wara l- operazzjoni, jew minħabba kateterizzazzjoni tal- vini, għandhom jiġu mmonitorjati b’ attenzjoni.
Patients with a history of allergic reactions should be carefully monitored.
Wara t- tqegħid fis- suq ġew irrapportati każijiet iżolati ta ’ reazzjonijiet ta ’ sensittività eċċessiva li jinkludu reazzjonijiet anafilattiċi.. Pazjenti b’ passat mediku ta ’ reazzjonijiet allerġiċi għandhom jiġu mmonitorjati b’ attenzjoni.
There have been no reports of antibodies against factor VII in haemophilia A or B patients.
Ma kienx hemm rapporti ta ’ antikorpi kontra l- fattur VII f’ pazjenti bl- emofilja A jew B.
Isolated cases of factor VII deficient patients developing antibodies against factor VII have been reported after treatment with NovoSeven.
Każijiet iżolati ta ’ pazjenti li huma nieqsa mill- fattur VII li żviluppaw antikorpi kontra l- fattur VII ġew irrappurtati wara l- kura b’ NovoSeven.
These patients have previously been treated with human plasma and/ or plasma-derived factor VII.
Dawn il- pazjenti kienu diġà kkurati permezz tal- plażma uman u/ jew permezz tal- fattur VII derivat mill- plażma.
In two patients the antibodies showed inhibitory effect in vitro.
F’ żewġ pazjenti l- antikorpi wrew effett inibitorju in vitro.
Patients with factor VII deficiency treated with NovoSeven should be monitored for factor VII antibodies.
Il- pazjenti li huma nieqsa mill- fattur VII għandhom jiġu mmonitorjati għall - antikorpi kontra l- fattur VII.
6 One case of angioneurotic oedema has been reported spontaneously in a patient with Glanzmann’ s thrombasthenia after administration of NovoSeven.
Każ wieħed ta ’ edema anġjonewrotika ġie rrappurtat spontanjament f’ pazjent li kellu it- trombastenja ta ’ Glanzmann wara li ngħata NovoSeven.
A thrombotic event has been reported in an elderly (> 80 year) male patient with factor VII deficiency treated with 10 - 20 times the recommended dose.
Ġie rrapportat avveniment trombotiku f’ pazjent anzjan (> 80 sena) li huwa nieqes mill- fattur VII li kien kkurat b’ doża 10- 20 darba ogħla minn dik rakkomandata.
No other thrombotic complications from overdose have been reported, not even after treatment of a 6 year old boy with haemophilia A with inhibitors with 8 - 10 times the recommended dose.
Ma kienu rrappurtati l- ebda komplikazzjonijiet trombotiċi oħra minħabba doża eċċessiva, lanqas wara l- kura ta ’ tifel ta ’ sitt snin li kellu l- emofilja A bl- inibituri u li ngħata doża 8- 10 darbiet ogħla minn dik rakkomandata.
Blood coagulation factors, ATC code:
Fatturi ta ’ koagulazzjoni tad- Demm, Kodiċi ATC:
NovoSeven contains activated recombinant coagulation factor VII.
NovoSeven fih il- fattur VII attivat tal- koagulazzjoni rikombinanti.
The mechanism of action includes the binding of factor VIIa to exposed tissue factor.
Il- mekkaniżmu ta ’ kif jaħdem jinkludi r- rabta tal- fattur VIIa mal- fattur tat- tessuti espost.
This complex activates factor IX into factor IXa and factor X into factor Xa, leading to the initial conversion of small amounts of prothrombin into thrombin.
Dan il- kumpless jattiva l- fattur IX biex isir fattur IXa u l- fattur X biex isir fattur Xa, li jwassal biex tibda l- ewwel konverżjoni ta ’ ammonti żgħar ta ’ prothrombin f’ thrombin.
Thrombin leads to the activation of platelets and factors V and VIII at the site of injury and to the formation of the haemostatic plug by converting fibrinogen into fibrin.
It- thrombin iwassal għall- attivazzjoni tal- plejtlets u tal- fatturi V u VIII fil- post fejn ikun hemm il- ferita u għall- formazzjoni tal- plagg emostatiku permezz tal- konverżjoni ta ’ fibrinogen għal fibrin.
Pharmacological doses of NovoSeven activate factor X directly on the surface of activated platelets, localized to the site of injury, independently of tissue factor.
Dożi farmakoloġiċi ta ’ NovoSeven jattivaw il- fattur X direttament fuq il- wiċċ tal- plejtlets attivati, li jkunu lokalizzati fis- sit tal- ferita, indipendentement mill- fattur tat- tessut.
This results in the conversion of prothrombin into large amounts of thrombin independently of tissue factor.
Dan jirriżulta fil- konverżjoni ta ’ prothrombin f’ ammonti kbar ta ’ thrombin indipendentement mill- fattur tat- tessuti.
Accordingly, the pharmacodynamic effect of factor VIIa gives rise to an increased local formation of factor Xa, thrombin and fibrin.
Għalhekk, l- effett farmakodinamiku tal- fattur VIIa, joħloq żieda fil- formazzjoni lokali tal - fattur Xa, thrombin u fibrin.
A theoretical risk for the development of systemic activation of the coagulation system in patients suffering from underlying diseases predisposing them to DIC cannot be totally excluded.
Riskju teoretiku għall- iżvilupp ta ’ attivazzjoni sistemika tas- sistema tal- koagulazzjoni f’ pazjenti li jbatu minn mard ieħor li jippredisponuhom għall- DIC, ma jistax jiġi eskluż għal kollox.
Healthy subjects
Suġġetti b’ saħħithom
Using the FVII clotting assay, the pharmacokinetics of NovoSeven were investigated in 35 healthy Caucasian and Japanese subjects in a dose-escalation study.
Permezz ta ’ studju ta ’ koagulazzjoni fuq il- fattur VII, il- karatteristiċi farmakokinetiċi ta ’ NovoSeven kienu investigati f’ 35 suġġett b’ saħħithom li kienu Kawkasi u Ġappuniżi, f’ studju fejn id- doża kienet tiżdied.
Subjects were stratified according to sex and ethnic group and dosed with 40, 80 and 160 µg NovoSeven per kg body weight and/ or placebo (3 doses each).
Is- suġġetti kien mqassma skond is- sess u grupp etniku u rċievew dożi ta ’ 40, 80, u 160µg NovoSeven għal kull kg ta ’ piż tal- ġisem u / jew plaċebo (3 dożi kull wieħed).
The pharmacokinetic profiles indicated dose proportionality.
Il- profili farmakokinetiċi jindikaw proporzjonalità fid- doża.
The pharmacokinetics were similar across sex and ethnic groups.
Ma kien hemm ebda differenza fil- karatteristiċi farmakokinetiċi fil- gruppi mqassma skond is- sess u skond l- etniċità.
The mean steady state volume of distribution ranged from 130 to 165 ml/ kg, the mean values of clearance ranged from 33.3 to 37.2 ml/ kg. h, and the mean terminal half-life ranged from 3.9 to 6.0 hours.
Il- medja tal- volum tad - distribuzzjoni fiss kienet tvarja minn 130 sa 165 ml/ kg, il- valuri medji ta ’ tneħħija kienu jvarjaw minn 33. 3 sa 37. 2 ml/ kg. siegħa u l- medja tal- half- life terminali kienet tvarja minn 3. 9 sa 6. 0 sigħat.
Haemophilia A and B with inhibitors
Emofilja A u B bl- inibituri
Dose proportionality was established in children for the investigated doses of 90 and 180 µg per kg body weight, which is in accordance with previous findings at lower doses (17.5 - 70 µg/ kg rFVIIa).
Permezz ta ’ studju ta ’ koagulazzjoni fuq il- fattur VIIa, il- karatteristiċi farmakokinetiċi ta ’ NovoSeven kienu investigati f’ 12- il pazjent pedjatriku (2 – 12- il sena) u 5 pazjenti adulti f’ stat mhux emorraġiku. Proporzjonalità fid- doża ġiet stabbilita fit- tfal għad- dozi ta ’ 90 u 180 µg għal kull kg ta ’ piż tal- ġisem li kienu taħt studju u li huwa skond dak li kien diġà instab għad- dożi aktar baxxi (17. 5 – 70 µg/ kg rFVIIa).
Mean clearance was approximately 50% higher in paediatric patients relative to adults (78 versus 53 ml/ kg. h), whereas the mean terminal half life was determined to 2.3 hours in both groups.
Il- medja ta ’ tneħħija kienet madwar 50% ogħla fil- pazjenti pedjatrici meta mqabbla ma ’ dik ta ’ l- adulti (78 kontra 53 ml/ kg. siegħa), waqt li l- medja tal- half- life terminali ġiet stabbilita għal 2. 3 sigħat fiż- żewġ gruppi.
Mean volume of distribution at steady state was 196 ml/ kg in paediatric patients versus 159 ml/ kg in adults.
Il- medja tal- volum tad- distribuzzjoni fiss kienet ta ’ 196 ml/ kg fil - pazjenti pedjatriċi kontra 159 ml/ kg fl- adulti.
Clearance appears related with age, therefore in younger patients clearance may be increased by more than 50%.
Jidher li t- tneħħija għandha x’ taqsam ma ’ l- età, għalhekk fil- pazjenti ż- żgħar it- tneħħija tista ’ tiżdied b’ iktar minn 50%.
Factor VII deficiency
Defiċjenza tal- fattur VII
7 difference between the two doses used with regard to dose-independent parameters: total body clearance (70.8 - 79.1 ml/ h. kg), volume of distribution at steady state (280 - 290 ml/ kg), mean residence time (3.75 - 3.80 h), and half-life (2.82 - 3.11 h).
Il- farmakokinetika tad- doża waħdanija ta ’ NovoSeven, 15 u 30 μg għal kull kilogramm ta ’ piż tal - ġisem, ma wriet ebda differenza sinifikanti bejn iż- żewġ dożi użati fir- rigward tal- parametri indipendenti mid- doża: it- tneħħija totali mill- ġisem (70. 8- 79. 1 ml/ siegħa. kg), il- volum tad - distribuzzjoni fl- istat fiss (280- 290 ml/ kg), il- medja tal- ħin ta ’ permanenza (3. 75- 3. 80 siegħa), u l - half- life (2. 82- 3. 11 siegħa).
The mean in vivo plasma recovery was approximately 20%.
Il- medja ta ’ l- irkupru tal- plażma in vivo kienet ta ’ madwar 20%.
Pharmacokinetics of NovoSeven in patients with Glanzmann’ s thrombasthenia have not been investigated, but are expected to be similar to the pharmacokinetics in haemophilia A and B patients.
8 Il- farmakokinetika ta ’ NovoSeven f’ pazjenti bi trombastenja ta ’ Glanzmann ma ġietx investigata, iżda mistennija li tkun tixbaħ il- farmakokinetika li ġiet murija f’ pazjenti b’ emofilja A u B.
All findings in the preclinical safety programme were related to the pharmacological effect of NovoSeven.
Is- sejbiet kollha fil- programm tas- sigurtà qabel l- użu kliniku kienu relatati ma ’ l- effett farmakoloġiku ta ’ NovoSeven.
Powder Sodium chloride Calcium chloride dihydrate Glycylglycine Polysorbate 80 Mannitol Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Trab Sodium chloride Calcium chloride dihydrate Glycylglycine Polysorbate 80 Mannitol Hydrochloric acid (għall- aġġustament tal- pH) Sodium hydroxide (għall- aġġustament tal- pH)
NovoSeven must not be mixed with infusion solutions or be given in a drip.
NovoSeven m’ għandux jitħallat ma ’ soluzzjonijiet ta ’ l- infużjoni jew jingħata fi dripp.
The shelf life is 3 years for the product packed for sale.
3 snin għall- prodott ippakkjat għall- bejgħ.
After reconstitution, chemical and physical stability has been demonstrated for 24 hours at 25°C.
Wara r- rikostituzzjoni, l- istabbilità kimika u fiżika ġiet ppruvata għal 24 siegħa f’ temperatura ta ’ 25°C. Minn perspettiva mikrobijoloġika, il- prodott għandu jiġi użat minnufih.
If not used immediately, storage time and storage conditions prior to use are the responsibility of the user, and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax minnufih, iż- żmien u l- kundizzjonijiet ta ’ hażna qabel l- użu, huma r- responsabbiltà ta ’ min jużah, u normalment m’ għandhomx ikunu ta ’ iktar minn 24 siegħa f’ temperatura ta ’ 2°C - 8°C, sakemm ir - rikostituzzjoni ma tkunx saret f’ kundizzjonijiet strettament asettiċi u validati.
– Store NovoSeven in a refrigerator (2°C - 8°C) – Store in original package in order to protect from light – Do not freeze to prevent damage to the solvent vial.
- Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl
Vials for NovoSeven:
Kunjetti għal NovoSeven:
Glass closed with a bromobutyl rubber stopper covered with an aluminium cap.
Tal- ħġieġ, magħluqa b’ tapp tal- gomma tal- bromobutyl, mgħottija b’ għatu ta ’ l- aluminju.
8 The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.
9 Il- kunjetti magħluqa huma mgħammra b’ għatu tal- polypropylene snap- off, li juri jekk kienx hemm tbagħbis.
Vials for solvent:
Kunjetti għas- solvent:
Glass closed with a bromobutyl rubber disc with teflon, covered with an aluminium cap.
Tal- ħġieġ, magħluqa b’ diska tal- gomma tal- bromobutyl bit- teflon, mgħottija b’ għatu ta ’ l- aluminju.
The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.
Il- kunjetti magħluqa huma mgħammra b’ għatu tal- polypropylene snap- off, li juri jekk kienx hemm tbagħbis.
Syringe for reconstitution and administration:
Il- pakkett ta ’ NovoSeven fih:
The sterile disposable syringe is made of polypropylene.
- kunjett 1 (2 ml) bi trab abjad (NovoSeven) għal soluzzjoni għall- injezzjoni
The NovoSeven package contains: – 1 vial (2 ml) with white powder (NovoSeven) for solution for injection – 1 vial (2 ml) with solvent (Water for injections) for reconstitution – 1 sterile vial adapter for reconstitution – 1 sterile disposable syringe for reconstitution and administration – 1 sterile infusion set for administration – 2 alcohol swabs for cleansing the rubber stoppers on the vials – Package leaflet with instructions for use.
- kunjett 1 (2 ml) bis- solvent (Ilma għall- injezzjonijiet) għar- rikostituzzjoni
6.6 Special precautions for disposal and other handling
- Fuljett ta ’ tagħrif bl- istruzzjonijiet dwar l- użu
Always use an aseptic technique
Dejjem uża teknika asettika
• Bring the NovoSeven powder and water vials to room temperature (but not above 37°C).
• Ġib it- trab ta ’ NovoSeven u l- kunjetti ta ’ l- ilma għat- temperatura ambjentali tal- kamra (iżda mhux iktar minn 37°C).
You can do this by holding them in your hands.
Tista ’ tagħmel dan billi żżommhom f’ idejk.
Remove the plastic caps from the two vials.
Neħħi l- għotjien tal- plastik miż- żewġ kunjetti.
If the caps are loose or missing, do not use the vials.
Jekk l- għotjien ma jkunux issikkati jew jkunu nieqsa, tużax il- kunjetti.
Clean the rubber stoppers on the vials with the alcohol swabs and allow them to dry before use. • Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap.
• Neħħi l- karta protettiva mill- adapter tal- kunjett mingħajr ma ’ toħroġ l- adapter tal- kunjett mill - għatu protettiv.
Attach the vial adapter to the solvent vial.
Waħħal l- adapter tal- kunjett mal- kunjett tas- solvent.
Take care not to touch the spike on the vial adapter.
Oqgħod attent li ma tmissx il- ponta ta ’ l- adapter.
Once attached, remove the protective cap from the vial adapter.
Ladarba jkun imwaħħal, neħħi l- għatu protettiv mill- adapter tal- kunjett.
• Pull the plunger to draw in a volume of air that is equal to the amount of solvent in the solvent vial (ml equals cc on the syringe).
• Iġbed il- planġer lura sabiex iddaħħal volum ta ’ arja li huwa l- istess daqs l- ammont ta ’ solvent li hemm fil- kunjett tas- solvent (fis- siringa ml huwa daqs cc).
• Screw the syringe tightly onto the vial adapter on the solvent vial.
• Issikka sew is- siringa għal ma ’ l- adapter tal- kunjett fuq il- kunjett tas- solvent.
Inject air into the vial by pushing the plunger until you feel a clear resistance.
Daħħal l- arja fil - kunjett billi timbotta l- planġer sakemm tħoss ammont sostanzjali ta ’ reżistenza.
• Hold the syringe with the water vial upside down and pull the plunger to draw the water into the syringe.
• Żomm is- siringa bil- kunjett ta ’ l- ilma ta ’ taħt fuq u iġbed il- planġer sabiex iddaħħal l- ilma fis - siringa.
• Remove the empty water vial by tipping the syringe with the vial adapter.
• Warrab il- kunjett vojt ta ’ l- ilma billi tmejjel is- siringa bl- adapter imwaħħal magħha.
• Click the vial adapter, still attached to the syringe, onto the powder vial.
• Qabbad l- adapter, li għadu mwaħħal fuq is- siringa, mal- kunjett tat- trab.
Hold the syringe slightly tilted with the vial facing downwards.
Żomm is- siringa daqsxejn inklinata bil- kunjett iħares ’ l isfel.
Push the plunger slowly to inject the water into the powder vial.
Imbotta bil- mod il- planger sabiex tinjetta l- ilma ġol- kunjett tat- trab.
Make sure not to aim the stream of water directly at the NovoSeven powder as this will cause foaming.
Oqgħod attent li l- ilma ma jmurx direttament fuq it- trab ta ’ NovoSeven sabiex tevita l- formazzjoni ta ’ ragħwa.
• Gently swirl the vial until all the powder is dissolved.
10 • Dawwar il- kunjett bil- mod sakemm it- trab jinhall kollu.
Do not shake the vial as this will cause foaming.
Iċċaqlaqx il- kunjett, sabiex tevita l - formazzjoni ta ’ ragħwa
NovoSeven reconstituted solution is colourless and should be inspected visually for particulate matter and discolouration prior to administration.
Is- soluzzjoni rikostitwita ta ’ NovoSeven m’ għandhiex kulur u qabel ma tingħata għandha tiġi eżaminata viżwalment għal xi frak u għal xi tibdil fil- kulur.
The enclosed disposable syringe is compatible with the reconstituted preparation, but do not store
Is- siringa li tintuża darba biss li hemm fil- pakkett hi kompatibbli mal- preparazzjoni rikostitwita iżda taħżinx NovoSeven rikostitwit f’ siringi tal- plastik.
It is recommended to use NovoSeven immediately after reconstitution.
Huwa rakkomandat li tuża NovoSeven immedjatament wara r- rikostituzzjoni.
Administration
Kif Jingħata
• Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the syringe).
• Assigura ruħek li l- planġer huwa mdaħħal kollu ’ l ġewwa qabel mad- dawwar is- siringa ta ’ taħt fuq (jista ’ jkun li nħareġ ’ il barra minħabba l- pressjoni fis- siringa).
Hold the syringe with the vial upside down and pull the plunger to draw all the solution into the syringe.
Żomm is- siringa bil- kunjett rasu ’ l isfel u iġbed lura l- planġer sabiex iddaħħal is- soluzzjoni kollha fis- siringa.
• Unscrew the vial adapter with the empty vial.
• Ħoll l- adapter flimkien mal- kunjett vojt.
• NovoSeven is now ready for injection.
• NovoSeven issa hu lest biex jiġi injettat.
Locate a suitable site, and slowly inject NovoSeven into a vein over a period of 2 - 5 minutes without removing the needle from the injection site.
Sib sit adattat, u bil- mod injetta NovoSeven ġo vina fuq perijodu ta ’ 2- 5 minuti mingħajr ma tneħħi l- labra mis- sit ta ’ l- injezzjoni.
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Novo Nordisk A/ S Novo Allè DK- 2880 Bagsværd Id- Danimarka
23 February 1996 Date of latest renewal:
23 ta ’ Frar 1996 Data ta ’ l- aħħar tiġdid:
23 February 2006
23 ta ’ Frar 2006
Detailed information on this 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 /
NovoSeven 2.4 mg (120 KIU) - powder and solvent for solution for injection
NovoSeven 2. 4 mg (120 KIU) - trab u solvent għal soluzzjoni għall- injezzjoni
NovoSeven is presented as powder and solvent for solution for injection containing 2.4 mg eptacog alfa (activated) per vial (corresponds to 120 KIU/ vial).
NovoSeven jiġi ppreżentat bħala trab u solvent għal soluzzjoni għall- injezzjoni li fih 2. 4 mg eptacog alfa (attivat) kull kunjett (jikkorrispondi għal 120 KUI/ kunjett).
NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: • in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda Units (BU) • in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration • in patients with acquired haemophilia • in patients with congenital FVII deficiency • in patients with Glanzmann ’ s thrombasthenia with antibodies to GP IIb - IIIa and/ or HLA, and with past or present refractoriness to platelet transfusions.
NovoSeven huwa indikat għall- kura ta ’ episodji ta ’ emorraġija u għall- prevenzjoni ta ’ l- emorraġija f’ dawk li tkun qed issirilhom operazzjoni jew proċeduri invażivi fil- gruppi ta ’ pazjenti li ġejjin • f’ pazjenti li għandhom emofilja konġenitali b’ inibituri għall- fatturi VIII jew IX tal - koagulazzjoni > 5 Unitajiet Bethesda (UB) • f’ pazjenti li għandhom emofilja konġenitali u li huwa mistenni li jkollhom rispons anamnestiku qawwi għall- għoti tal- fattur VIII jew tal- fattur IX • f’ pazjenti li għandhom emofilja akkwiżita • f’ pazjenti li għandhom nuqqas konġenitali ta ’ FVII • f’ pazjenti li għandhom trombastenja ta ’ Glanzmann b’ antikorpi għal GP IIb- IIIa u/ jew HLA, u b’ reżistenza fil- passat jew fil- preżent għal trasfużjonijiet tal- plejtlets.
The recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight.
Huwa rakkomandat li l- ewwel doża, mogħtija b’ injezzjoni bolus minn ġol- vini, tkun ta ’ 90 µg għal kull kilogramm ta ’ piż tal- ġisem.
Following the initial dose of NovoSeven further injections may be repeated.
12 Wara l- ewwel doża ta ’ NovoSeven, jistgħu jiġu ripetuti iżjed injezzjonijiet.
11 Dosing in children Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.
Dożaġġ fit- tfal S’ issa l- esperjenza klinika ma turix li hemm il- bżonn ta ’ dożaġġ differenti ħafna bejn dik tat- tfal u dik ta ’ l- adulti, għalkemm it- tneħħja fit- tfal tkun aktar mgħaġġla milli fl- adulti.
The recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight.
Doża u intervall bejn doża u oħra NovoSeven għandu jingħata kmienu kemm jista ’ jkun wara li jkun beda episodju ta ’ emorraġija. Huwa rakkomandat li l- ewwel doża, mgħotija permezz ta ’ injezzjoni bolus minn ġol- vini, tkun ta ’ 90 µg
12 Dose, dose range and dose interval The recommended dose range for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 15 - 30 μ g per kg body weight every 4 - 6 hours until haemostasis is achieved.
Il- limiti rakkomandati tad- doża għall- kura ta ’ episodji ta ’ emorraġija f’ pazjenti li fuqhom saret operazzjoni jew proċeduri invażivi huma ta ’ 15- 30 µg għal kull kilogramm ta ’ piż tal- ġisem kull 4 sa 6 sigħat sakemm tintlaħaq l- emostasi.
Method of adminsitration
Metodu ta 'kif jingħata