qanastek/EMEA-V3 huggingface dataset:
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 trombotiċi jew li jkun hemm Koagulazzjoni Intravaskulari Disseminata (Disseminated Intravascular Coagulation- DIC) meta tingħata l- kura ta ’ NovoSeven.
Such situations may include patients with advanced atherosclerotic disease, crush injury, septicaemia or DIC.
14 Dawn is- sitwazzjonijiet jistgħu jinkludu pazjenti b’ mard aterosklerotiku avvanzat, leżjonijiet minħabba tgħaffiġ, settiċemija jew DIC.
Patients
F' każ ta 'xokk, għandha tiġi implimentata l- kura medika normali għal xokk.
13 should be informed of the early signs of hypersensitivity reactions.
Il- pazjenti għandhom jiġu infurmati x' inhuma s- sinjali bikrija ta 'reazzjonijiet ta' sensittività eċċessiva.
If such symptoms occur, the 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.
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.
Tagħrif fuq numru limitat ta ’ użu waqt it- tqala skond l- indikazzjonijiet approvati ma jurux effetti mhux mixtieqa ta 'rFVIIa fuq it- tqala jew fuq saħħet il- fetu/ tarbija tat- twelid.
To date, no other relevant epidemiological data are available.
Sa llum, m’ hemm l- ebda tagħrif epidemjoloġiku relevanti ieħor.
Use during lactation:
15 L- użu waqt it- treddigħ:
No effects on the breastfed newborn/ infant are anticipated.
Għandha tingħata attenzjoni meta NovoSeven jingħata lil nisa li qed ireddgħu. Mhux mistennija li jkun hemm effetti fuq it- tarbija tat- twelid/ tarbija li qed tredda '.
Described below under ‘ serious adverse reactions reported during the post-marketing period’.
Deskritt hawn taħt bħala ‘ reazzjonijiet avversi serji rrapportati matul il- perijodu ta ’ wara t- tqegħid fis- suq ’.
Gastrointestinal disorders
Rari ħafna (< 1/ 10, 000)
Very rare (< 1/ 10,000)
Tqalligħ.
Nausea.
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata
General disorders and administration site conditions Rare (> 1/ 10,000, < 1/ 1,000)
Rari (> 1/ 10, 000, < 1/ 1, 000)
Nervous system disorders Very rare (< 1/ 10,000)
Disturbi fis- sistema nervuża
Cerebrovascular disorders including cerebral infarction and cerebral ischaemia have been reported:
Rari ħafna (< 1/ 10, 000)
Skin and subcutaneous tissue disorders Very rare (< 1/ 10,000)
Deskritti hawn taħt bħala ‘ reazzjonijiet avversi serji rrapportati matul il- perijodu ta ’ wara t- tqegħid fis- suq ’.
Skin rashes may occur.
16 Disturbi fil- ġilda u fit- tessut ta ’ taħt il- ġilda
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
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.
15 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.
NovoSeven contains activated recombinant coagulation factor VII.
17 NovoSeven fih il- fattur VII attivat tal- koagulazzjoni rikombinanti.
16 Single dose pharmacokinetics of NovoSeven, 15 and 30 μ g per kg body weight, showed no significant 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).
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.
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.
18 Is- sejbiet kollha fil- programm tas- sigurtà qabel l- użu kliniku kienu relatati ma ’ l- effett farmakoloġiku ta ’ NovoSeven.
17 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.
The sterile disposable syringe is made of polypropylene.
- kunjett 1 (5 ml) bi trab abjad (NovoSeven) għal soluzzjoni għall- injezzjoni
The NovoSeven package contains: – 1 vial (5 ml) with white powder (NovoSeven) for solution for injection – 1 vial (5 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 (5 ml) bis- solvent (Ilma għall- injezzjonijiet) għar- rikostituzzjoni
6.6 Special precautions for disposal and other handling
- sett 1 sterili ta ’ l- infużjoni biex tingħata d- doża
Clean the rubber stoppers on the vials with the alcohol swabs and allow them to dry before use.
Naddaf it- tappijiet tal- gomma tal- kunjetti bil- biċċiet tat- tajjar imxarrbin bl- alkoħol u ħallihom jinxfu qabel ma tużahom.
• 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.
• Gently swirl the vial until all the powder is dissolved.
• Dawwar il- kunjett bil- mod sakemm it- trab jinhall kollu.
18 The enclosed disposable syringe is compatible with the reconstituted preparation, but do not store reconstituted NovoSeven in plastic syringes.
Is- siringa li tintuża darba biss li hemm fil- pakkett hi kompatibbli mal- preparazzjoni rikostitwita iżda taħżinx NovoSeven rikostitwit f’ siringi tal- plastik.
Administration
20 Kif Jingħata
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..
NovoSeven 4.8 mg (240 KIU) - powder and solvent for solution for injection
NovoSeven 4. 8 mg (240 KIU) - trab u solvent għal soluzzjoni għall- injezzjoni
NovoSeven is presented as powder and solvent for solution for injection containing 4.8 mg eptacog alfa (activated) per vial (corresponds to 240 KIU/ vial).
NovoSeven jiġi ppreżentat bħala trab u solvent għal soluzzjoni għall- injezzjoni li fih 4. 8 mg eptacog alfa (attivat) kull kunjett (jikkorrispondi għal 240 KUI/ kunjett).
Following the initial dose of NovoSeven further injections may be repeated.
22 Wara l- ewwel doża ta ’ NovoSeven, jistgħu jiġu ripetuti iżjed injezzjonijiet.
20 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.
21 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.
Doża, il- limiti tad- doża u l- intervall bejn doża u oħra 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, 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).
Doża, il- limiti tad- doża u l- intervall bejn doża u oħra 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).
Such situations may include patients with advanced atherosclerotic disease, crush injury, septicaemia or DIC.
24 Dawn is- sitwazzjonijiet jistgħu jinkludu pazjenti b’ mard aterosklerotiku avvanzat, leżjonijiet minħabba tgħaffiġ, settiċemija jew DIC.
22 should be informed of the early signs of hypersensitivity reactions.
Il- pazjenti għandhom jiġu infurmati x' inhuma s- sinjali bikrija ta 'reazzjonijiet ta' sensittività eċċessiva.
Use during lactation:
25 L- użu waqt it- treddigħ:
Skin rashes may occur.
26 Disturbi fil- ġilda u fit- tessut ta ’ taħt il- ġilda
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.
24 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.
NovoSeven contains activated recombinant coagulation factor VII.
27 NovoSeven fih il- fattur VII attivat tal- koagulazzjoni rikombinanti.
25 Single dose pharmacokinetics of NovoSeven, 15 and 30 μ g per kg body weight, showed no significant 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).
All findings in the preclinical safety programme were related to the pharmacological effect of NovoSeven.
28 Is- sejbiet kollha fil- programm tas- sigurtà qabel l- użu kliniku kienu relatati ma ’ l- effett farmakoloġiku ta ’ NovoSeven.
6.3 Shelf life
6. 4 Żmien kemm idum tajjeb il- prodott mediċinali
26 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.
The sterile disposable syringe is made of polypropylene.
- kunjett 1 (12 ml) bi trab abjad (NovoSeven) għal soluzzjoni għall- injezzjoni
The NovoSeven package contains: – 1 vial (12 ml) with white powder (NovoSeven) for solution for injection – 1 vial (12 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 (12 ml) bis- solvent (Ilma għall- injezzjonijiet) għar- rikostituzzjoni
6.6 Special precautions for disposal and other handling
- sett sterili 1 ta ’ l- infużjoni biex tingħata d- doża
• 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 ’ l isfel il- planġer sabiex iddaħħal l - ilma fis- siringa.
27 The enclosed disposable syringe is compatible with the reconstituted preparation, but do not store reconstituted NovoSeven in plastic syringes.
Is- siringa li tintuża darba biss li hemm fil- pakkett hi kompatibbli mal- preparazzjoni rikostitwita iżda taħżinx NovoSeven rikostitwit f’ siringi tal- plastik.
Administration
30 Kif Jingħata
NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection
NovoSeven 1 mg (50 KUI) trab u solvent għal soluzzjoni għall- injezzjoni
NovoSeven is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/ vial).
NovoSeven jiġi ppreżentat bħala trab u solvent għal soluzzjoni għall- injezzjoni li fih 1 mg eptacog alfa (attivat) kull kunjett (jikkorrispondi għal 50 KUI/ kunjett).
eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Dalton produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology.
eptacog alfa (attivat) huwa l- fattur VIIa rikombinanti tal- koagulazzjoni (rFVIIa) b’ massa molekulari ta ’ madwar 50, 000 Dalton prodott fiċ- ċelluli tal- kliewi tal- frieħ tal- ħamster (Ċelluli BHK) permezz ta 'teknoloġija ta' DNA rikombinanti.
After reconstitution, the product contains 1 mg/ ml eptacog alfa (activated) and 10 mg/ ml sucrose when reconstituted with solvent.
Wara r- rikostituzzjoni, il- prodott fih 1 mg/ ml eptacog alfa (attivat) u 10 mg/ ml sucrose meta jiġi rrikostitwit bis- solvent.
White lyophilized powder.
Trab abjad lajofilizzat.
Solvent: clear colourless solution.
Solvent: soluzzjoni ċara bla kulur.
The reconstituted solution has a pH of approximately 6.0.
Is- soluzzjoni rikostitwita għandha pH ta 'madwar 6. 0.
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- sorveljanza ta 'tabib b' esperjenza fil- kura ta' l- emofilja u/ jew disturbi emorraġiċi.
Posology Haemophilia A or B with inhibitors or expected to have a high anamnestic response
Pożoloġija 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.
32 NovoSeven għandu jingħata malajr kemm jista ’ jkun wara li jkun beda episodju ta ’ emorraġija.
Following the initial dose of NovoSeven further injections may be repeated.
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
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.
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.
33 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 għal kull kg ta ’ piż tal- ġisem.
30 Factor VII deficiency
Pazjenti neqsin mill- Fattur VII
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.
Doża, il- limiti tad- doża u l- intervall bejn doża u oħra 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.
After administration of rFVIIa, 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 rFVIIa.
Wara l- għoti ta ’ rFVIIa, 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 ’ rFVIIa.
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.
34 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 trombotiċi jew li jkun hemm Koagulazzjoni Intravaskulari Disseminata (Disseminated Intravascular Coagulation- DIC) meta tingħata l- kura ta ’ NovoSeven.
In such cases treatment with antihistamines i. v. should be considered.
F' dawn il- każijiet għandha tiġi kkunsidrata l- kura permezz ta’ antistaminiċi mogħtija minn ġol- vini.
If allergic or anaphylactic-type reactions occur, the administration should be discontinued
Jekk iseħħu reazzjonijiet allerġiċi jew tat- tip anafilattiku, it- teħid għandu jitwaqqaf minnufih.
Patients should be informed of the early signs of hypersensitivity reactions.
Il- pazjenti għandhom jiġu infurmati x' inhuma s- sinjali bikrija ta 'reazzjonijiet ta' sensittività eċċessiva.
Patients with rare hereditary problems of fructose intolerance, glucose malabsorption or sucrose- isomaltase insufficiency should not take this medicine
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall- fructose, disfunzjoni fl- assorbiment ta ’ glucose jew insuffiċjenza ta ’ sucrose- isomaltase m’ għandhomx jieħdu din il- mediċina.
Experience with concomitant administration of anti-fibrinolytics and rFVIIa treatment is however limited.
Madankollu, l- esperjenza bl- għoti fl - istess ħin ta ’ sustanzi anti- fibrinolitiċi u l- kura b’ rFVIIa, hi limitata.
4.6 Pregnancy and lactation
35 4. 6 Tqala u Treddigħ
Use during lactation:
Użu waqt it- treddigħ:
32 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 Very rare (< 1/ 10,000)
Rari ħafna (< 1/ 10, 000)
Very rare (< 1/ 10,000)
36 Rari ħafna (< 1/ 10, 000)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serju jitniżżel l- ewwel.
Serious adverse reactions reported during the post-marketing period include: – Arterial thrombotic events such as myocardial infarctions or ischaemia, cerebrovascular disorders and bowel infarction.
Reazzjonijiet avversi serji li ġew irrappurtati matul il- perijodu ta ’ wara t- tqegħid fis- suq jinkludu:
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..
33 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 rFVIIa.
Każijiet iżolati ta ’ pazjenti li huma nieqsa mill- fattur VII li żviluppaw antikorpi kontra l- fattur VII ġew irrappurtati wara l- kura b’ rFVIIa.
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.
Patients with factor VII deficiency treated with NovoSeven should be monitored for factor VII antibodies.
Il- pazjenti li huma nieqsa mill- fattur VII, ikkurati b’ NovoSeven, għandhom jiġu mmonitorjati għall- antikorpi kontra l- fattur VII.
One case of angioneurotic oedema has been reported spontaneously in a patient with Glanzmann’ s thrombasthenia after administration of rFVIIa.
Każ wieħed ta ’ edema anġjonewrotika ġie rrappurtat spontanjament f’ pazjent li kellu it- trombastenja ta ’ Glanzmann wara li ngħata rFVIIa.
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.
37 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.
Using the FVII clotting assay, the pharmacokinetics of rFVIIa 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 ’ rFVIIa 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 rFVIIa 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 rFVIIa għal kull kg ta ’ piż tal- ġisem u / jew plaċebo (3 dożi kull wieħed).
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.
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 ’ rFVIIa 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 volume of distribution at steady state was 196 ml/ kg in
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.
34 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.
Single dose pharmacokinetics of rFVIIa, 15 and 30 μ g per kg body weight, showed no significant 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).
38 Il- farmakokinetika tad- doża waħdanija ta ’ rFVIIa, 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).
All findings in the preclinical safety programme were related to the pharmacological effect of rFVIIa.
Is- sejbiet kollha fil- programm tas- sigurtà qabel l- użu kliniku kienu relatati ma ’ l- effett farmakoloġiku ta ’ rFVIIa.
Powder Sodium chloride Calcium chloride dihydrate Glycylglycine Polysorbate 80 Mannitol Sucrose Methionine Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Trab Sodium chloride Calcium chloride dihydrate Glycylglycine Polysorbate 80 Mannitol Sucrose Methionine Hydrochloric acid (għall- aġġustament tal- pH) Sodium hydroxide (għall- aġġustament tal- pH)
Solvent Histidine Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
Solvent Histidine Hydrochloric acid (għall- aġġustament tal- pH) Sodium hydroxide (għall- aġġustament tal- pH) Ilma għall- injezzjonijiet
The shelf life is 2 years for the product packed for sale.
Sentejn għall- prodott ippakkjat għall- bejgħ.
After reconstitution, chemical and physical stability have been demonstrated for 6 hours at 25°C and 24 hours at 5°C.
Wara r- rikostituzzjoni, l- istabbilità kimika u fiżika ġiet ippruvata għal 6 sigħat f’ temperatura ta ’ 25°C u għal 24 siegħa f' temperatura ta '5°C.
From a microbiological point of view, the product should be used immediately.
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 should 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 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.
35 6.4 Special precautions for storage
39 6. 4 Prekawzjonijiet speċjali għall- ħażna
– Store powder and solvent below 25°C. – Store powder and solvent protected from light. – Do not freeze to prevent damage to the solvent vial. – For storage conditions of the reconstituted medicinal product, see section 6.3.
- Għall- kundizzjonijiet ta 'kif jinħażen il- prodott mediċinali rikostitwit, ara sezzjoni 6. 3.
The NovoSeven package contains Type I glass vials closed with a chlorobutyl rubber stopper, covered with an aluminium cap. The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.
Il- kunjetti magħluqa huma mgħammra b' għatu ta 'polypropylene, li jurik jekk sarx tbagħbis u jinfetaħ b' tifqigħa.
Each NovoSeven package contains: – 1 vial (2 ml) with white powder for solution for injection – 1 vial (2 ml) with solvent for reconstitution
- kunjett 1 (2 ml) bis- solvent għar- rikostituzzjoni
• NovoSeven powder and solvent vials should be at room temperature at reconstitution.
• Il- kunjetti bit- trab u s- solvent ta ’ NovoSeven għandhom ikunu f' temperatura tal- kamra waqt ir - rikostituzzjoni.
Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use.
Naddaf it- tappijiet tal- gomma tal- kunjetti b' biċċiet tat- tajjar imxarrbin bl- alkoħol u ħallihom jinxfu qabel ma tużahom.
Use a disposable syringe of an appropriate size and a vial adapter, transfer needle (20 - 26G) or other suitable device.
Uża siringa li tintrema wara l- użu ta 'daqs adattat u adapter għall- kunjett, labra għat- trasferiment (20 – 26G) jew apparat xieraq ieħor.
• Attach the vial adapter to the solvent vial.
• Waħħal l- adapter għall- kunjett mal- kunjett tas- solvent.
If using a transfer needle, screw the transfer needle tightly onto the syringe.
Jekk qiegħed tuża labra ta ’ trasferiment, invita sew il- labra ta ’ trasferiment fuq is- siringa.
• Screw the syringe tightly onto the vial adapter on the solvent vial.
• Invita sew is- siringa ma ’ l- adapter għall- kunjett li qiegħed fuq il- kunjett tas- solvent.
If using a transfer needle, insert the transfer needle into the rubber stopper of the solvent vial.
Jekk qiegħed tuża labra ta ’ trasferiment, daħħal il- labra ta ’ trasferiment fit- tapp tal- gomma tal - kunjett tas- solvent.
Inject air into the vial by pushing the plunger until you feel a clear resistance.
Injetta l- arja ġol- kunjett billi timbotta l- planġer sakemm tħoss reżistenza netta.
• Hold the syringe with the solvent vial upside down.
• Żomm is- siringa bil- kunjett tas- solvent ta ’ taħt fuq.
If using a transfer needle, make sure the transfer needle tip is in the solvent.
Jekk qiegħed tuża labra ta ’ trasferiment, kun żgur li l- ponta tal- labra ta ’ trasferiment tkun fis- solvent.
Pull the plunger to draw the solvent into the syringe.
Iġbed il- planġer sabiex iddaħħal is- solvent fis- siringa.
• Remove the empty solvent vial.
• Aqla 'l- kunjett vojt tas- solvent.
If using a vial adapter, tip the syringe to remove it from the vial.
Jekk qiegħed tuża adapter għall- kunjett, mejjel is- siringa biex taqlagħha minn mal- kunjett.
• Attach the syringe with the vial adapter or transfer needle to the powder vial.
• Waħħal is- siringa jew bl- adapter għall- kunjett jew b’ labra ta ’ trasferiment mal- kunjett tat- trab.
If using a transfer needle, make sure to penetrate the centre of the rubber stopper.
Jekk qiegħed tuża labra ta ’ trasferiment, kun żgur li tippenetra ċ- ċentru tat- tapp tal- gomma.
Push the plunger slowly to inject the solvent into the powder vial.
Imbotta bil- mod il- planger sabiex tinjetta s- solvent ġol- kunjett tat- trab.
Make sure not to aim the stream of solvent directly at the NovoSeven powder as this will cause foaming.
Oqgħod attent li s- solvent ma jmurx direttament fuq it - trab ta ’ NovoSeven sabiex tevita l- formazzjoni ta ’ ragħwa.
• Gently swirl the vial until all the powder is dissolved.
40 • Dawwar il- kunjett bil- mod sakemm it- trab jinħall kollu.
Do not store reconstituted NovoSeven in plastic syringes.
Taħżinx NovoSeven rikostitwit f’ siringi tal- plastik.
36 It is recommended to use NovoSeven immediately after reconstitution.
Huwa rakkomandat li tuża NovoSeven immedjatament wara r- rikostituzzjoni.
• 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 ma ddawwar is- siringa ta ’ taħt fuq (jista ’ jkun li nħareġ ’ il barra minħabba l- pressjoni fis- siringa).
If using a transfer needle, make sure the transfer needle tip is in the solution.
Jekk qiegħed tuża labra ta ’ trasferiment, kun żgur li l- ponta tal- labra ta ’ trasferiment tkun fis- soluzzjoni.
• If using a vial adapter, unscrew the vial adapter with the empty vial.
• Jekk qiegħed tuża adapter għall- kunjett, ħoll l- adapter bil- kunjett vojt.
If using a transfer needle, remove the transfer needle from the vial, replace the transfer needle cap, and twist the transfer needle off the syringe.
Jekk qiegħed tuża labra ta ’ trasferiment, aqla 'l- labra ta ’ trasferiment minn mal- kunjett, erġa ’ poġġi l- għatu fuq il- labra ta ’ trasferiment, u dawwar il- labra ta ’ trasferiment sakemm tinqala' minn mas- siringa.
Safely dispose of the syringe, vials and any unused product.
Armi s- siringa, il- kunjetti u kull fdal tal- prodott b' mod li ma jkunux ta 'periklu.
NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection
NovoSeven 2 mg (100 KUI) - trab u solvent għal soluzzjoni għall- injezzjoni
NovoSeven is presented as powder and solvent for solution for injection containing 2 mg eptacog alfa (activated) per vial (corresponds to 100 KIU/ vial).
NovoSeven jiġi ppreżentat bħala trab u solvent għal soluzzjoni għall- injezzjoni li fih 2 mg eptacog alfa (attivat) kull kunjett (jikkorrispondi għal 100 KUI/ kunjett).
Dose NovoSeven should be given as early as possible after the start of a bleeding episode.
42 NovoSeven għandu jingħata malajr kemm jista ’ jkun wara li jkun beda episodju ta ’ emorraġija.
The duration of treatment
Wara l- ewwel doża ta ’ NovoSeven, jistgħu jiġu ripetuti iżjed injezzjonijiet.
38 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.
The recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight.
43 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 għal kull kg ta ’ piż tal- ġisem.
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
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.
In such cases treatment with antihistamines i. v. should be considered.
F' dawn il- każijiet għandha tiġi kkunsidrata l- kura permezz ta ’ antistaminiċi mogħtija minn ġol- vini.
40 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.
Patients with rare hereditary problems of fructose intolerance, glucose malabsorption or sucrose- isomaltase insufficiency should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall- fructose, disfunzjoni fl- assorbiment ta ’ glucose jew insuffiċjenza ta ’ sucrose- isomaltase m’ għandhomx jieħdu din il- mediċina.
As a precautionary measure, it is preferable to avoid use of NovoSeven during pregnancy.
45 Bħala miżura ta 'prekawzjoni, huwa preferibbli li jiġi evitat l- użu ta' NovoSeven waqt it- tqala.
NovoSeven can be used during breast-feeding.
NovoSeven jista 'jintuża waqt it- treddigħ
Blood and lymphatic disorders
Rari ħafna (< 1/ 10, 000)
Few cases of coagulopathic disorders such as increased D-dimer and consumptive coagulopathy have been reported.
Kienu rrapportati xi ftit każijiet ta ’ disturbi koagulopatiċi bħal żieda fid- D - dimer u l- koagulopatija ta ’ konsum.
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.
Nervous system disorders Very rare (< 1/ 10,000)
46 Disturbi fis- sistema nervuża
42 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.
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.
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
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.
Single dose pharmacokinetics of rFVIIa, 15 and 30 μ g per kg body weight, showed no significant 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 ’ rFVIIa, 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).
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.
48 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.
6.3 Shelf life
6. 5 Żmien kemm idum tajjeb il- prodott mediċinali
After reconstitution, chemical and physical stability have been demonstrated for 6 hours at 25°C and 24 hours at 5°C.
Wara r- rikostituzzjoni, l- istabbilità kimika u fiżika ġiet ppruvata għal 6 sigħat f’ temperatura ta ’ 25°C u 24 siegħa f' temperatura ta '5°C.
6.5 Nature and contents of container
49 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
• Screw the syringe tightly onto the vial adapter on the solvent vial.
• Issika s- siringa sew fil- kamin ta 'l- adapter għall- kunjett fuq il- kunjett tas- solvent.
If using a transfer needle, insert the transfer needle into the rubber stopper of the solvent vial.
Jekk qiegħed tuża labra ta ’ trasferiment, daħħal il- labra ta ’ trasferiment fit- tapp tal- gomma tal- kunjett tas - solvent.
Hold the syringe slightly tilted with the vial facing downwards.
Jekk qiegħed tuża labra ta ’ trasferiment, kun żgur li tippenetra ċ- ċentru tat- tapp tal - gomma. Żomm is- siringa daqsxejn inklinata bil- kunjett iħares ’ l isfel.
Push the plunger slowly to inject the solvent into the powder vial.
Imbotta bilmod il- planger sabiex tinjetta s- solvent ġol- kunjett tat- trab.
Make sure not to aim the stream of solvent directly at the NovoSeven powder as this will cause foaming.
Oqgħod attent li s- solvent ma jmurx direttament fuq it- trab ta ’ NovoSeven sabiex tevita l- formazzjoni ta ’ ragħwa.
• Gently swirl the vial until all the powder is dissolved.
• Dawwar il- kunjett bilmod sakemm it- trab jinhall kollu.
45 Do not store reconstituted NovoSeven in plastic syringes.
Taħżinx NovoSeven rikostitwit f’ siringi tal- plastik.
Administration
50 Kif Jingħata
• If using a vial adpater, unscrew the vial adapter with the empty vial.
• Jekk qiegħed tuża adapter għall- kunjett, ħoll l- adapter għall- kunjett bil- kunjett vojt.
NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection
NovoSeven 5 mg (250 KUI) trab u solvent għal soluzzjoni għall- injezzjoni
NovoSeven is presented as powder and solvent for solution for injection containing 5 mg eptacog alfa (activated) per vial (corresponds to 250 KIU/ vial).
NovoSeven jiġi ppreżentat bħala trab u solvent għal soluzzjoni għall- injezzjoni li fih 5 mg eptacog alfa (attivat) kull kunjett (jikkorrispondi għal 250 KUI/ kunjett).
After reconstitution, the product contains 1 mg/ ml eptacog alfa (activated)and 10 mg/ ml sucrose when reconstituted with solvent.
Wara r- rikostituzzjoni, il- prodott fih 1 mg/ ml eptacog alfa (attivat) u 10 mg/ ml sucrose meta jiġi rrikostitwit bis- solvent.
Dose NovoSeven should be given as early as possible after the start of a bleeding episode.
52 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 µg per kg body weight.
53 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 għal kull kg ta ’ piż tal- ġisem.
48 Factor VII deficiency
Pazjenti neqsin mill- Fattur VII
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.
54 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 trombotiċi jew li jkun hemm Koagulazzjoni Intravaskulari Disseminata (Disseminated Intravascular Coagulation- DIC) meta tingħata l- kura ta ’ NovoSeven.
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.
49 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.
Experience with concomitant administration of anti-fibrinolytics and rFVIIa treatment is however limited.
Madankollu, l- esperjenza bl- għoti fl - istess ħin ta ’ sustanzi anti- fibrinolitiċi u l- kura b ’ rFVIIa, hi limitata.
4.6 Pregnancy and lactation
55 4. 6 Tqala u Treddigħ
Few cases of coagulopathic disorders such as increased D-dimer and
Rari ħafna (< 1/ 10, 000)
50 consumptive coagulopathy have been reported.
Kienu rrapportati xi ftit każijiet ta ’ disturbi koagulopatiċi bħal żieda fid- D - dimer u l- koagulopatija ta ’ konsum.
Increase of alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and prothrombin levels have been reported.
Ġew irrapportati żieda fl- alanine aminotransferase, alkaline phosphatase,
Nervous system disorders Very rare (< 1/ 10,000)
56 lactate dehydrogenase u fil- livelli tal- prothrombin.
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 “ Twissijiet speċjali u prekawzjonijiet għall- użu ”.
51 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.
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.
57 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.
52 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.
Single dose pharmacokinetics of rFVIIa, 15 and 30 μ g per kg body weight, showed no significant 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 ’ rFVIIa, 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
6.3 Shelf life
6. 6 Żmien kemm idum tajjeb il- prodott mediċinali
Each NovoSeven package contains: – 1 vial (12 ml) with white powder for solution for injection – 1 vial (12 ml) with solvent for reconstitution
- kunjett 1 (12 ml) bis- solvent għar- rikostituzzjoni
If using a transfer needle, screw the transfer needle tightly onto the syringe.
Jekk qiegħed tuża labra ta ’ trasferiment, issikaha sew fil- kamin tas- siringa.
If using a transfer needle, insert the transfer needle into the rubber stopper of the solvent vial.
Jekk qiegħed tuża labra ta ’ trasferiment, daħħal il- labra fit- tapp tal- gomma tal- kunjett tas- solvent.
Inject air into the vial by pushing the plunger until you feel a clear resistance.
Injetta l - arja ġol- kunjett billi timbotta l- planġer sakemm tħoss reżistenza netta.
Do not store reconstituted NovoSeven in plastic syringes.
60 Taħżinx NovoSeven rikostitwit f’ siringi tal- plastik.
54 It is recommended to use NovoSeven immediately after reconstitution.
Huwa rakkomandat li tuża NovoSeven immedjatament wara r- rikostituzzjoni.
• If using a vial adapter, unscrew the vial adapter with the empty vial.
• Jekk qiegħed tuża adapter għall- kunjett, ħoll l- adapter għall- kunjett bil- kunjett vojt.
55 ANNEX II
61 ANNESS II
Name and address of the manufacturers of the biological active substance(s)
Isem u indirizz tal- manifatturi tas- sustanza( i) bijoloġika( ċi) attiva( i)
Novo Nordisk A/ S Brennum Park DK-3400 Hillerød Denmark
Novo Nordisk A/ S Brennum Park DK- 3400 Hillerød Id- Danimarka