qanastek/EMEA-V3 huggingface dataset:
No other medicines should be injected through the line reserved for Rapilysin, neither at the same time, nor prior to, nor following Rapilysin injection.
L- ebda medikazzjoni oħra m’ għandha tiġi injettata minn ġol- pajp riservat għal Rapilysin, la fl- istess ħin, la qabel, u lanqas wara l- injezzjoni ta ’ Rapilysin.
This applies to all products including heparin, and acetylsalicylic acid, which should be administered before and following the administration of reteplase to reduce the risk of re-thrombosis.
Dan japplika għall - prodotti kollha inkluż heparin, u acetylsalicylic acid, li għandhom jingħataw qabel u wara l- għotja ta ’ reteplase biex inaqqsu r- riskju ta ’ trombożi mill- ġdid.
In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with 0.9% sodium chloride or 5% dextrose solution prior to and following the Rapilysin injection.
F’ dawk il- pazjenti fejn l- istess pajp irid jiġi użat, dan il- pajp (inkluż il- Y- pajp) għandu jiġi mlaħlaħ bl - akbar reqqa b’ 0. 9% soluzzjoni ta ’ sodium chloride jew 5% soluzzjoni ta ’ dextrose, qabel u wara l - injezzjoni ta ’ Rapilysin.
2 Dosage of Rapilysin
2 Dożaġġ tar- Rapilysin
Rapilysin is administered as a 10 U bolus dose followed by a second 10 U bolus dose 30 minutes later (double bolus).
Rapilysin jingħata bħala 10 U doża injettata segwita mit- tieni 10 U doża injettata 30 minuta wara (injezzjoni doppja).
Each bolus is administered as a slow intravenous injection within 2 minutes.
Kull injezzjoni tingħata bħala injezzjoni bil- mod ġol- vini fuq perjodu ta ’ 2 minuti.
Ensure that the injection is not mistakenly given paravenously.
Assigura li l - injezzjoni ma tingħatax bi żball barra mill- vina.
Heparin and acetylsalicylic acid should be administered before and following the administration of Rapilysin to reduce the risk of rethrombosis.
Heparin u acetylsalicylic acid għandhom jiġu mogħtija qabel u wara l- għotja ta ’ Rapilysin biex inaqqsu r- riskju ta ’ ritrombożi.
Dosage of Heparin
Dożaġġ ta ’ Eparina
The recommended dose of heparin is 5000 I. U. given as a bolus injection prior to reteplase therapy followed by an infusion of 1000 I. U. per hour starting after the second reteplase bolus.
Id- doża rrakkommandata ta ’ eparina hija ta ’ 5000 I. U. mogħtija bħala injezzjoni qabel it- terapija ta ’ reteplase segwita minn infużjoni ta ’ 1000 I. U. kull siegħa li tibda wara t- tieni injezzjoni ta ’ reteplase.
Heparin should be administered for at least 24 hours, preferably for 48 – 72 hours, aiming to keep aPTT values 1.5 to 2 times normal.
Eparina għandha tingħata għal mill- inqas 24 siegħa, preferibilment għal 48 – 72 siegħa, bl- iskop li jżomm valuri ta ’ l- aPTT minn 1. 5 sa 2 ta ’ dawk normali.
Dosage of Acetylsalicylic Acid
Dożaġġ ta ’ Acetylsalicylic Acid
The initial dose of acetylsalicylic acid prior to thrombolysis should be at least 250 mg (250 – 350 mg) followed by 75 – 150 mg/ day at least until discharge.
Id- doża tal- bidu ta ’ acetylsalicylic acid qabel it- trombolożi għandha tkun mill- inqas ta ’ 250 mg (250 – 350 mg) segwita minn mill- inqas 75 – 150 mg/ kuljum sa meta l- pazjent joħroġ mill- isptar.
Use in children There is no experience in children
Użu fit- tfal M’ hemm l- ebda esperjenza fit- tfal
Hypersensitivity to reteplase, polysorbate 80 or any of the other ingredients.
Sensittività eċċessiva għas- sustanza attiva reteplase, għal polysorbate 80 jew għal xi sustanzi mhux attivi.
Because thrombolytic therapy increases the risk of bleeding, reteplase is contra-indicated in the following situations:
Minħabba li t- terapija trombolitika żżid ir- riskju ta ’ ħruġ tad- demm, reteplase huwa kontra- indikat fis - sitwazzjonijiet li ġejjin:
- known haemorrhagic diathesis
- pazjenti li hu magħruf li għandhom dijatesi emorragika
- patients with current concomitant therapy with oral anticoagulants (e. g. warfarin sodium)
- pazjenti b’ terapija konkomitanti kurrenti b’ mediċina kontra t- tagħqid tad- demm meħuda mill -
- intracranial neoplasm, arteriovenous malformation or aneurysm
- neoplażma fil- kranju, formazzjoni difettuża arterjovenuża jew anewriżma
- neoplasm with increased bleeding risk
- neoplażma b’ riskju miżjud ta ’ ħruġ tad- demm
- history of cerebrovascular accident
- storja ta ’ aċċident ċerebrovaskulari
- recent (< 10 days) prolonged and vigorous external heart massage
- massaġġ tal- qalb estern reċenti (< 10 ġranet) fit- tul u vigoruż
- severe uncontrolled hypertension
- pressjoni għolja serja mhux ikkontrollata
- active peptic ulceration
- ulċera attiva ta ’ l- istonku
- portal hypertension (oesophageal varices)
- pressjoni għolja portali (variċi esofagali)
- severe liver or renal dysfunction
- anormalità serja tal- fwied jew tal- kliewi
- acute pancreatitis, pericarditis, bacterial endocarditis
- pankreatite akuta, perikardite, endokardite tal- batterji akuta
- within 3 months of severe bleeding, major trauma or major surgery (e. g. coronary artery bypass
- fi żmien 3 xhur minn ħruġ tad- demm serju, trawma serja jew operazzjoni serja (eż. ‘ bypass
graft, intracranial or intraspinal surgery or trauma), obstetrical delivery, organ biopsy, previous puncture of non-compressible vessels.
graft’ graft ta ’ l- arterja koronarja, operazzjoni jew trawma fil- kranju jew intraspinali), twelid,
3 4.4 Special warnings and precautions for use
3 bijopsija ta ’ xi organu, vini u arterji li ma jistgħux ikunu kompressati kkompressati li kienu mtaqqba fil- passat.
Each patient being considered for therapy with reteplase should be carefully evaluated.
Kull pazjent li qed ikun ikkunsidrat għat- terapija b’ reteplase għandu jiġi evalwat b’ attenzjoni.
For information on product incompatibilities see section 6.2
Għal informazzjoni dwar l- inkompatibilitajiet tal- prodott ara sezzjoni 6. 2.
Bleeding
Ħruġ tad- demm
The most common complication encountered during reteplase therapy is bleeding.
L- aktar komplikazzjoni komuni li wieħed jiltaqa ’ magħha waqt it- terapija b’ reteplase huwa l- ħruġ tad - demm.
In the following conditions the risks of reteplase therapy may be increased and should be weighed against the anticipated benefits:
F’ dawn il- kondizzjonijiet li ġejjin ir- riskji tat- terapija b’ reteplase jistgħu jiżdiedu u wieħed għandu jiżinhom u jqabbilhom mal- ġid li jista’ jieħu bit- terapija:
- cerebrovascular disease
- mard ċerebrovaskulari
- systolic blood pressure at entry > 160 mmHg
- pressjoni tad- demm sistolika ta ’ > 160 mmHg meta jkun deċiż it- trattament
- recent gastrointestinal or genitourinary bleeding (within 10 days)
- ħruġ tad- demm gastrointestinali jew ġenitourinarju reċenti (fl- aħħar 10 t’ ijiem)
- high likelihood of left heart thrombus, e. g. mitral stenosis with atrial fibrillation
- probabbiltà għolja ta ’ trombus tax- xellug tal- qalb, eż. stenosi mitrali ma ’ fibrilazzjoni atrijali
- septic thrombophlebitis or occluded arteriovenous cannula at seriously infected site
- tromboflebite settika jew kannula arterjovenuża miżduda f’ xi parti infettata serjament
- age over 75 years
- età ta ’ aktar minn 75 sena
- any other condition in which bleeding constitutes a significant hazard or would be particularly
- xi kondizzjoni oħra fejn il- ħruġ tad- demm jikkostitwixxi periklu sinifikanti jew li jkun
difficult because of its location
partikularment diffiċli minħabba l- post fejn ikun
The concomitant use of heparin anticoagulation may contribute to bleeding.
L- użu konkomitanti ta ’ eparina kontra t- tagħqid tad- demm jista ’ jinkontribwixxi għall- ħruġ tad- demm.
As fibrin is lysed during reteplase therapy, bleeding from recent puncture sites may occur.
Waqt li fibrin huwa ddiżintegrat waqt it- terapija b’ reteplase, il- ħruġ tad- demm minn partijiet li kienu mtaqqba reċentement jista ’ jseħħ.
Therefore, thrombolytic therapy requires careful attention to all possible bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cut down sites and needle puncture sites).
Għalhekk, it- terapija trombolitika teħtieġ attenzjoni partikulari għall- partijiet kollha fejn il- ħruġ tad- demm hu possibbli (inklużi partijiet fejn kien hemm inserzjoni bil- katerer, partijiet arterjali u tal- vini li kienu mtaqqba, ‘ cut down sites ’ u partijiet li kienu mtaqqba bil- labar).
The use of rigid catheter as well as intramuscular injections and nonessential handling of the patient should be avoided during treatment with reteplase.
L- użu ta ’ katerer iebes kif ukoll l- injezzjonijiet intermuskolari u t- tqandil mhux essenzjali tal- pazjent għandhom jiġu evitati waqt it- trattament b’ reteplase.
Caution should be employed when used with other medicinal products affecting haemostasis such as heparin, low-molecular-weight heparins, heparinoids, oral anticoagulants and antiplatelet agents other than acetylsalicylic acid, such as dipyridamole, ticlopidine, clopidogrel or glycoprotein IIb/ IIIa receptor antagonists.
Attenzjoni għandha tingħata meta t- terapija trombolitika tkun użata ma ’ prodotti mediċinali oħra li jaffettwaw l- emostasi bħall- eparina, eparini li għandhom piż molekulari baxx, eparinojdi, mediċina kontra t- tagħqid tad- demm u aġenti ta ’ kontra l- plejtlets meħuda mill- ħalq, minbarra acetylsalicylic acid, bħal dipyridamole, ticlopidine, clopidogrel jew glycoprotein IIb/ IIIa antagonisti tar- riċettur.
Should serious bleeding, in particular cerebral haemorrhage, occur any concomitant heparin should be terminated immediately.
Jekk ħruġ serju tad- demm, partikularment emorraġija ċerebrali, iseħħ, kull eparina konkomitanti għandha titwaqqaf minnufih.
In addition, the second bolus of reteplase should not be given if the serious bleeding occurs before it is administered.
Flimkien ma ’ dan, it- tieni injezzjoni ta’ ta ’ reteplase m’ għandhiex jingħata jekk ħruġ serju tad- demm iseħħ qabel din mogħtija.
In general, however, it is not necessary to replace the coagulation factors because of the relatively short half-life of reteplase.
Madankollu, ġeneralment, mhux neċessarju li tibdel il- fatturi tat- tagħqid tad- demm minħabba l- half life relattivament qasirs ta ’ reteplase j hu qasir.
Most patients who have bleeding can be managed by interruption of thrombolytic and anticoagulant therapy, volume replacement and manual pressure applied to an incompetent vessel.
Il- biċċa l- kbira tal- pazjenti li għandhom il- ħruġ tad- demm jistgħu jiġu mmaniġġjati bl- interruzzjoni tat- terapija trombolitika u bil- mediċina kontra t- tagħqid tad- demm, bil - bdil fil- volum u bi pressjoni manwali applikata lil xi vina jew arterja marida.
Protamine should be considered if heparin has been administered within 4 hours of the onset of bleeding.
Protamine għandu jiġi kkunsidrat jekk Eparina kienet amministrata fi żmien 4 siegħat mill- bidu tal- ħruġ tad- demm.
In the patients who fail to respond to these conservative measures, judicious use of transfusion products may be indicated.
F’ pazjenti li ma jirrispondux għal dawn il- miżuri konservattivi, l- użu prudenti ta ’ prodotti tat - trasfużjoni jista jkun indikat.
Transfusions of cryoprecipitate, fibrinogen, fresh frozen plasma and platelets should be considered with clinical and laboratory reassessment after each administration.
Trasfużjonijiet ta ’ cryoprecipitate, fibrinoġen, plażma friska ffriżata u plejtlets għandhom jiġu kkunsidrati ma ’ rivalutazzjoni klinika u tal- laboratorju wara kull għoti.
A target fibrinogen level of 1 g/ l is desirable with cryoprecipitate or fibrinogen infusion.
Il- mira mixtieqa tal- livell tal- fibrinoġen hi ta ’ 1 g/ l ma ’ cryoprecipitate jew ma ’ l- infużjoni tal- fibrinoġen.
At present, insufficient data in patients with a diastolic blood pressure > 100 mmHg prior to thrombolytic therapy are available for reteplase.
Bħalissa, hemm informazzjoni insuffiċjenti disponibbli għal reteplase dwar pazjenti bi pressjoni tad - demm dijastolika ta ’ > 100 mmHg qabel it- terapija trombolitika.
4 Arrhythmias
4 Arritmiji
Coronary thrombolysis may result in arrhythmias associated with reperfusion.
It- trombolożi koronarja tista ’ tirriżulta f’ arritmiji assoċjati ma ’ likwidu li jgħaddi minn xi organu mill - ġdid (‘ reperfusion’ reperfusion).
It is strongly recommended that antiarrhythmic therapy for bradycardia and/ or ventricular tachyarrhythmias (e. g. ventricular tachycardia or fibrillation) be available when reteplase is administered.
Huwa rrakkommandat bil- qawwa li t- terapija antiarritmijaka għall - bradikardija u/ jew takiarritmiji ventrikulari (eż. takikardija jew fibrillazzjoni ventrikulari) tkun disponibbli meta reteplase jkun mogħti.
Readministration
Għoti mill- ġdid
Since at present there is no experience with readministration of reteplase, the readministration is not recommended.
Billi bħalissa mhemmm’ hemm l- ebda esperjenza dwar l- għoti mill- ġdid tar- ta ’ reteplase, l- għoti mill - ġdid mhuwiex irrakkommandat.
However, no antibody formation to the reteplase molecule has been observed.
Madankollu, l- ebda formazzjoni ta ’ anti- korp għall- molekula tar- ta ’ reteplase ma kienet osservata.
If an anaphylactoid reaction occurs, the injection should be discontinued immediately and appropriate therapy should be initiated.
Jekk reazzjoni anafilattojdi sseħħ, l- injezzjoni għandha tiġi mwaqqfa minnufih u terapija adattata għandha tiġi mibdija.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott.
No interaction studies with reteplase and medicinal product commonly administered in patients with AMI have been performed.
Ma sarux studji dwar l- effett ta ’ prodotti mediċinali komunement mogħtija f’ pazjenti b’ AMI fuq l - effett farmaċewtiku reteplase.
Retrospective analyses of clinical studies did not reveal any clinically relevant interactions with medicinal product used concomitantly with reteplase in patients with acute myocardial infarction.
Analiżi retrospettiva ta ’ studji kliniċi ma żvelatx xi azzjonijiet reċiproċi klinikament rilevanti ma ’ prodotti mediċinali użati konkomitament ma ’ reteplase f’ pazjenti b’ infart mijokardjali akut.
Heparin, vitamin K antagonists and medicinal product that alter platelet function (such as acetylsalicylic acid, dipyridamole and abciximab) may increase the risk of bleeding if administered prior to, during or after reteplase therapy.
Heparin, antagonisti tal- vitamina K u prodotti mediċinali li jibdlu l- funzjoni tal - plejtlits (bħal acetylsalicylic acid, dipyridamole u abciximab) jisgħu jżidu r- riskju ta ’ ħruġ tad- demm jekk ikunu mogħtija qabel, waqt jew wara t- terapija b’ reteplase.
Attention should be paid to this effect especially during periods of low plasma fibrinogen (up to about 2 days after fibrinolytic therapy of AMI).
Attenzjoni għandha tingħata għal dan l- effett, speċjalment waqt perjodi ta ’ fibrinoġen tal- plażma baxx (sa madwar jumejn wara t- terapija fibrinolitika ta ’ l- AMI).
For information on product incompatibilities see section 4.2.
Għal informazzjoni dwar l- inkompatibilitajiet tal- prodott ara sezzjoni 4. 2.
4.6 Pregnancy and lactation
4. 6 It- Tqala u effetti fuq il- ħalib tas- sider
There are no adequate data on the use of reteplase in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ reteplase waqt it- tqala.
The only relevant available animal data refer to studies performed in rabbits, which showed vaginal bleedings associated with abortions (see section 5.3) The potential risk for humans is unknown.
Ir- riskju potenzjali għal bnedmin mhuwiex magħruf.
Except in life-threatening situations, Rapilysin should not be used in pregnant women.
Ħlief f’ sitwazzjonijiet ta ’ periklu għall- ħajja, Rapilysin m’ għandux jintuża fin- nisa tqal.
It is not known whether reteplase is excreted into breast milk.
M’ huwiex magħruf jekk reteplase huwiex imneħħi mal- ħalib tas- sider.
Breast milk should be discarded within the first 24 hours after thrombolytic therapy.
Il- ħalib tas- sider għandu jintrema fl- ewwel 24 siegħa wara t- terapija trombolitika.
Not relevant
Mhux rilevanti.
The most commonly reported adverse drug reaction associated with reteplase treatment is haemorrhage, predominantly at the injection site.
L- aktar reazzjoni avversa tal- prodott mediċinali rrappurtata b’ mod komuni assoċjata ma ’ kura b’ reteplase hija emorraġġija, l- aktar fil- lok ta ’ l- injezzjoni.
Local reactions at injection site can also occur.
Reazzjonijiet lokali fis- sit ta ’ l- injezzjoni jistgħu jseħħu wkoll.
As with other thrombolytic agents, recurrent ischaemia / angina, hypotension and heart failure / pulmonary oedema have been reported frequently as sequelae of myocardial infarction and / or thrombolytic administration.
Bħal b’ aġenti trombolitiċi oħra, iskemija / anġina rikorrenti, ipotensjoni u insuffiċjenza tal- qalb / edema pulmonary kienu rrappurtati b’ mod frekwenti bħala konsegwenza ta ’ infart mijokardijaku u / jew għotja trombolitika.
The frequency of the adverse drug reactions is described using the following convention:
5 F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjeta ’ tagħhom.
Very common Common Uncommon Rare Very rare
L- effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
≥ 1/ 10 ≥ 1/ 100, < 1/ 10 ≥ 1/ 1,000 ,< 1/100 ≥ 1/10 ,000 >, < 1/ 1,000 < 1/ 10,000, (including isolated reports)
≥ 1/ 10 Komuni ħafna ≥ 1/ 100, < 1/ 10 Komuni ≥ 1/ 1, 000, < 1/ 100 Mhux komuni ≥ 1/ 10, 000 >, < 1/ 1, 000 Rari ≥ 1/ 10, 000, (inklużi rapporti iżolati) Rari ħafna
The most frequent adverse drug reaction associated with reteplase treatment is haemorrhage.
L- aktar reazzjoni mhux mixtieqa frekwenti tal- mediċina assoċjata mat- trattament b’ reteplase hija l - emorraġija.
- very common: bleeding at the injection site (e. g. haematoma)
- komuni ħafna: ħruġ tad- demm fil- parti injettata (eż. ematoma)
- common: as gastrointestinal (haematemesis, melena), gingival or genitourinary bleeding
- komuni: bħall- ħruġ tad- demm gastrointestinali (ematemesi, melena), ġenġivali jew
- uncommon: haemopericardium, retroperitoneal bleeding, cerebral haemorrhage, epistaxis,
- mhux komuni: ħruġ tad- demm emoperikardju, retroperitonali, emorraġija ċerebrali, epistassi,
haemoptysis, eye haemorrhage and ecchymosis were observed.
emoptisi, emorraġija fl- għajnejn u ekkimosi kienu osservati.
Reports of intracranial bleeding, many of which are fatal, are of particular concern.
Rapporti ta ’ ħruġ tad- demm fil- kranju, li ħafna minnhom huma fatali, huma ta ’ tħassib partikulari.
Systolic blood pressure over 160 mmHg before thrombolysis with reteplase was associated with greater risk for cerebral bleeding.
Pressjoni tad- demm sistolika ta ’ aktar minn 160 mmHg qabel it- trombolożi ma ’ reteplase kienet assoċjata ma ’ riskju ikbar għall- ħruġ tad- demm ċerebrali.
The risk of intracranial bleeding and fatal intracranial bleeding increases with increasing age.
Ir- riskju ta ’ ħruġ tad- demm fil- kranju u ħruġ tad- demm fatali fil- kranju jiżdied bl’ età.
Blood transfusions were rarely required.
Trasfużjonijiet tad- demm rarament kienu meħtieġa.
Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.
Mewt u diżabilità permanenti ġew irrapportatiirrappurtati f’ pazjenti li kellhom puplesija (inkluż ħruġ tad - demm fil- kranju) u episodji oħra serji ta ’ ħruġ tad- demm.
As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and / or thrombolytic administration.
Disturbi kardjovaskulari Bħall- aġenti oħra trombolitiċi, l- okkorrenzi li ġejjin ġew irrapportati bħala konsegwenza ta ’ infart mijokardjali u / jew ta ’ għoti trombolitiku.
- very common: recurrent ischaemia / angina, hypotension and heart failure / pulmonary oedema
- komuni ħafna: iskemija / anġina rikorrenti, pressjoni baxxa ħafna u attakk tal- qalb / edema
- common: arrhythmias (e. g.
pulmonari
AV block, atrial fibrillation / flutter, ventricular tachycardia /
- komuni: arritmiji (eż. ostruzzjoni ta ’ l- AV, fibrilazzjoni atrijali / taħbit tal- qalb irregolari,
fibrillation, electromechanical dissociation (EMD)), cardiac arrest, cardiogenic shock and reinfarction
takikardija ventrikulari / fibrillazzjoni, dissoċjazzjoni elettromekkanika (EMD)), waqfien tal - qalb, xokk kardjoġeniku u infart ripetut
- uncommon: mitral regurgitation, pulmonary embolism, other systemic embolism / cerebral
- mhux komuni: rigurġitazzjoni mitrali, emboliżmu pulmonari, emboliżmu sistematiku ieħor /
embolism and ventricular septal defect
emboliżmu ċerebrali u difett tas- septum ventrikulari
These cardiovascular events can be life-threatening and may lead to death.
Dawn l- okkorrenzi kardjovaskulari jistgħu jkunu ta ’ periklu għall- ħajja u jistgħu jwasslu għall- mewt.
- uncommon: cerebral haemorrhage was observed.
- mhux komuni: emorraġija ċerebrali kienet osservata.
- very rare: events related to the nervous system (e. g. epileptic seizure, convulsion, aphasia,
- rari ħafna: okkorrenzi konnessi mas- sistema nervuża (eż. attakk epilettiku, konvulżjoni, afasja,
speech disorder, delirium, acute brain syndrome, agitation, confusion, depression, psychosis)
taħwid fid- diskors, thewdin, sindrome akut tal- moħħ, aġitazzjoni, konfużjoni, dipressjoni, psikosi)
Ischaemic or haemorrhagic cerebrovascular events may be contributing or underlying conditions.
Okkorrenzi iskemiċi jew emorraġiċi ċerebrovaskulari jistgħu jkunu kondizzjonijiet kontributtivi jew bażiċi.
General disorders and administration site conditions
6 Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
- very common: haemorrhage at the injection site (e. g. haematoma); a local reaction at injection
- komuni ħafna: emorraġija fil- parti ta ’ l- injezzjoni (eż. ematoma); reazzjoni lokali fil- parti ta ’ l -
site for example a burning sensation can occur.
injezzjoni, per eżempju, sensazzjoni ta ’ ħruq, tista ’ sseħħ.
- uncommon: hypersensitivity reactions (e. g. allergic reactions)
- mhux komuni: reazzjonijiet minħabba sensittività eċċessiva (eż. reazzjonijiet allerġiċi)
- very rare: serious anaphylaxis/ anaphylactoid reactions
- rari ħafna: reazzjonijiet anafilassiċi / anafilattojdi serji
Available evidence on reteplase does not indicate an antibody-mediated origin of these hypersensitivity reactions.
L- evidenza disponibbli dwar reteplase ma tindikax l- oriġini medjata ta ’ l- anti- korpi ta ’ dawn ir - reazzjonijiet minħabba sensittività eċċessiva.
6 4.9 Overdose
4. 9 Doża eċċessiva
In the event of overdosage one might expect depletion of fibrinogen and other blood coagulation components (e. g. coagulation factor V) with a consequent risk of bleeding.
F’ każ ta ’ doża eċċessiva wieħed jista ’ jistenna t- tnaqqis tal- fibrinoġen u tal- komponenti l- oħra tat - tagħqid tad- demm (eż. fattur V tat- tagħqid tad- demm) ma ’ riskju konsegwenti ta ’ ħruġ tad- demm.
For further information see section 4.4, section bleeding.
Għal aktar informazzjoni ara sezzjoni 4. 4, fis- sezzjoni tal- ħruġ tad- demm.
Pharmaco-therapeutic group: antithrombotic agent, ATC Code:
Kategorija farmakoterapewtika: aġent antitrombotiku, Kodiċi ATC:
Reteplase is a recombinant plasminogen activator that catalyzes the cleavage of endogenous plasminogen to generate plasmin.
Reteplase huwa attivatur rikombinanti tal- plażminoġen li jikkatalizza l- qtugħ (dak li jkisser il - molekula) endoġeniku tal- plażminoġen biex jipproduċi l- plażmin.
This plasminogenolysis occurs preferentially in the presence of fibrin.
Din il- plażminoġenolożi sseħħ preferenzjalment fil- preżenza tal- fibrin.
Plasmin in turn degrades fibrin, which is the main component of the matrix of thrombi, thereby exerting its thrombolytic action.
Il- plażmin wara, jiddegrada l- fibrin, li huwa l- komponent prinċipali tal- matriċi tat- trombi (‘ thrombi’ thrombi), u permezz ta ’ dan, jeżerċita l- azzjoni trombolitika tiegħu.
Reteplase (10+10 U) dose-dependently reduces plasma fibrinogen levels by about 60 to 80%.
Reteplase (10+10 U) dipendentement mid- doża, inaqqas il- livelli tal- fibrinogen fil- plażma b’ madwar 60 sa 80%.
The fibrinogen level normalises within 2 days.
Il- livell tal- fibrinogen jinnormalizza ruħu fi żmien jumejn.
As with other plasminogen activators a rebound phenomenon then occurs during which fibrinogen levels reach a maximum within 9 days and remain elevated for up to 18 days.
Bħall- attivaturi oħra tal - plasminogen, il- fenomenu ta ’ ‘ rebound ’ imbagħad isseħħ waqt li l- livelli tal- fibrinogen jilħqu massimu fi żmien 9 t’ ijiem u jibqgħu għoljin sa 18- il jum.
Reductions of plasma levels of plasminogen and α 2-antiplasmin normalise within 1 to 3 days.
Tnaqqis fil- livelli tal- plażma tal- plasminogen u ta ’ l- α2- antiplasmin jinnormalizzaw fi żmien 1 sa 3 t’ ijiem.
Coagulation factor V, clotting factor VIII, α 2-macroglobulin, and C1-esterase inhibitor are only slightly reduced and normalise within 1 to 2 days.
Il- fattur V tat- tagħqid tad- demm, fattur VIII tat- tagħqid tad- demm, α2- makroglobulina, u l - inibitur ta ’ C1- esterase huma biss kemmxejn imnaqqsa u jinnormalizzaw fi żmien jum sa jumejn.
Plasminogen activator inhibitor 1 (PAI-1) activity can be reduced to around zero, but rapidly normalises within two hours showing a rebound phenomenon.
L - attività ta ’ l- inibitur ta ’ l- attivatur tal- plasminoġen 1 (PAI- 1) tista ’ tkun imnaqqsa għal madwar żero, iżda tinnormalizza malajr fi żmien sagħtejn, filwaqt li turi l- fenomenu ta ’ rebound ’.
Prothrombin activation fragment 1 levels and thrombin-antithrombin III-complexes increase during thrombolysis indicating thrombin production of which the clinical relevance is unknown.
Il- framment ta ’ l - attivazzjoni ta ’ protrombin tal- livelli 1 u t- trombin- antitrombin kumplessi- III iżżid waqt it- trombolożi u tindika l- produzzjoni tat- trombin, liema rilevanza klinika mhijiex magħrufa.
A large comparative mortality trial (INJECT) in approx.
Reteplase (10+10 U) dipendentement mid- doża, inaqqas il- livelli ta ’ fibrinogen fil- plażma b’ madwar 60 sa 80%.
6000 patients showed that reteplase reduced the incidence of heart failure (secondary efficacy criterion) in a significant manner and was at least equally effective in terms of reducing mortality (primary efficacy criterion) when compared to streptokinase.
Prova kbira komparattiva tal- mortalità (INJECT) f’ madwar 6 000 pazjent uriet li reteplase naqqas l - inċidenza ta ’ attakki tal- qalb (kriterju sekondarju ta ’ l- effikaċja) b’ mod sinifikanti, u kien mill- inqas effettiv indaqs, fit- termini tan- nuqqas tal- mortalità (kriterju primarju ta ’ l- effikaċja), meta mqabbel ma ’ streptokinase.
In two clinical trials aiming primarily at coronary artery patency (RAPID I and II) reteplase was associated with higher early patency rates (primary efficacy criterion), as well as with a lower incidence of heart failure (secondary efficacy criterion) than alteplase (3 hour and "accelerated" dosage regimens).
F’ żewġ provi kliniċi bl- iskop ewlieni tal- ftuħ ta ’ arterja koronarja imblukkata (RAPID I u II) reteplase kien assoċjat ma ’ rati għola ta ’ ftuħ tal- bidu (kriterju primarju ta ’ l- effikaċja), kif ukoll ma ’ inċidenza aktar baxxa ta ’ attakki tal- qalb (kriterju sekondarju ta ’ l- effikaċja) minn alteplase (kors ta ’ 3 sigħat u dożaġġ "aċċelerat").
A clinical trial in approximately 15 000 patients comparing reteplase with the accelerated dose regimen of alteplase (GUSTO III) (2:1 randomisation reteplase: alteplase) did not show statistically different results for the primary endpoint of 30-day mortality (reteplase:
Prova klinika f’ madwar 15 000 pazjent li qabblet reteplase ma ’ kors ta ’ doża aċċelerat ta ’ alteplase (GUSTO III) (2: 1 randomisation reteplase: alteplase) ma weriex riżultati statistikament differenti għal endpoint primarju ta ’ mortalità f’ perjodu ta ’ 30 jum (reteplase:
7.47%, alteplase 7.23%, p = 0.61) or for the combined endpoint of 30-day mortality and non-fatal disabling stroke (reteplase:
7. 47%, alteplase 7. 23%, p = 0. 61) jew għal endpoint mħallta ta ’ mortalità f’ perijodu ta ’ 30 jum u f’ puplesija mhux fatali li tikkawża diżabilità (reteplase:
7.89%, alteplase 7.88%, p = 0.99).
7. 89%, alteplase 7. 88%, p = 0. 99).
Overall stroke rates were 1.64% in the reteplase and 1.79% in the alteplase group.
Ir- rati totali ta ’ puplesija kienu ta ’ 1. 64% fil- grupp ta ’ reteplase u ta ’ 1. 79% fil- grupp ta ’ alteplase.
In the reteplase group, 49.4% of these strokes were fatal and 27.1% were disabling.
Fil- grupp ta ’ reteplase, 49. 4% ta ’ dawn il- puplesiji kienu fatali u 27. 1% ikkawżaw diżabilità.
In the alteplase group 33.0% were fatal and 39.8% were disabling.
Fil - grupp ta ’ alteplase 33. 0% kienu fatali u 39. 8% kkawżaw diżabilità.
Following intravenous bolus injection of 10 + 10 U in patients with acute myocardial infarction reteplase antigen is distributed in plasma with a dominant half-life (t1/ 2α) of 18±5 min and eliminated with a terminal half-life (t1/ 2ß) of 5.5 hours±12.5 min at a clearance rate of 121±25 ml/ min.
Wara injezzjoni ġol- vini ta ’ 10 + 10 U f’ pazjenti b’ infart mijokardjali akut, l- antiġen ta ’ reteplase huwa mqassam fil- plażma b’ half life (t1/ 2α) dominanti ta ’ 18±5 min u eliminat ma ’ half life (t1/ 2ß) terminali ta ’ 5. 5 sigħat±12. 5 min b’ rata ta ’ tneħħija mill- ġisem ta ’ 121±25 ml/ min.
Reteplase activity is cleared from the plasma at a rate of 283±101 ml/ min, resulting in a dominant half-life (t1/ 2α) of 14.6±6.7 min and a terminal half-life (t1/ 2ß) of 1.6 hours±39 min.
L- attività ta’ reteplase hija mneħħija mill- plażma bir- rata ta ’ 283±101 ml/ min, li tirriżulta f’ half life (t1/ 2α) dominanti ta ’ 14. 6±6. 7 min u half life (t1/ 2ß) terminali ta ’ 1. 6 sigħat±39 min.
Only minor amounts of reteplase were immunologically detected in the urine.
Ammonti żgħar biss ta ’ reteplase kienu immunoloġikament osservati fl- awrina.
Exact data on the main elimination routes for reteplase in humans are not available and the consequences of hepatic or renal insufficiency are not known.
Informazzjoni eżatta dwar ir- rotot ta ’ l - eliminazzjoni prinċipali għal reteplase fil- bnedmin mhumiex disponibbli u l- konsegwenzi ta ’ insuffiċjenza epatika jew tal- kliewi mhumiex magħrufa.
Experiments in rats indicate that the liver and the kidneys are the main organs of active uptake and lysosomal degradation.
Esperimenti fil- firien ma indikawx li l- fwied u l- kliewi huma l- organi prinċipali ta ’ l- użu attiv u degradazzjoni lisosomali.
7 Additional studies in human plasma samples in vitro suggest that complexation with C1-inactivator, α 2-antiplasmin and α 2-antitrypsin contributes to the inactivation of reteplase in plasma.
Studji addizzjonali ta ’ kampjuni ta ’ plażma tal- bnedmin in vitro jissuġġerixxu li l- azzjoni reċiproka ma ’ inattivatur- C1, antiplażmin- α2 - u antitrypsin- α2 tikkontribwixxi għall- inattivazzjoni ta ’ reteplase fil- plażma.
C1-inactivator > α 2- antiplasmin > α 2-antitrypsin.
Il- kontribuzzjoni relattiva mill- inibituri għall- inattivazzjoni ta ’ reteplase tonqos kif ġej: inattivatur- C1 > antiplażmin- α2 > antitrypsin- α2.
The half-life of reteplase was increased in patients with AMI as compared to healthy volunteers.
Il- half life ta’ reteplase kienet iżjed f’ pazjenti bl- AMI meta mqabbla ma ’ voluntiera b’ saħħithom.
An additional increase of half-life of activity in patients with myocardial infarction and severely impaired liver and renal function cannot be excluded, but no clinical data of pharmacokinetics of reteplase in these patients are available.
Żjieda addizzjonali ta ’ attività tal - half life f’ pazjenti b’ infart mijokardjali u b’ mard serju tal- fwied u tal- funzjoni tal- kliewi ma tistax tiġi eskluża, iżda l- ebda informazzjoni klinika ta ’ farmakokinetiċi ta’ ta ’ reteplase f’ dawn il- pazjenti mhi disponibbli.
Animal data show that in case of severely impaired renal function with a pronounced increase in serum creatinine and serum urea an increase in half-life of reteplase has to be expected.
Informazzjoni miksuba minn studji fuq annimali ma wrietx li f’ każ ta ’ mard serju tal- funzjoni tal- kliewi flimkien ma ’ żjieda qawwija tal- kreatinina fis - serum u urea fis- serum, żjieda fil - half life ta’ reteplase għandha tkun mistennija.
Mild impairment of renal function did not significantly affect the pharmacokinetic properties of reteplase.
Mard ħafif tal - funzjoni tal- kliewi m’ affettwax b’ mod sinifikattiv il- proprjetajiet farmakokinetiċi ta ’ reteplase.
Acute toxicity studies were performed in rats, rabbits and monkeys Subacute toxicity studies were performed in rats, dogs and monkeys.
Studji ta ’ tossiċità subakuta kienu magħmula f’ firien, klieb u xadini.
The predominant acute symptom after single high doses of reteplase in rats and rabbits was transient apathy shortly after injection.
Is- sintomu akut predominanti wara dożi għolja waħedhom ta ’ reteplase f’ firien u fniek kienet apatija li tgħaddi ftit wara l- injezzjoni.
In cynomolgus monkeys, the sedative effect ranged from slight apathy to unconsciousness, caused by a reversible dose-related drop in blood pressure.
F’ xadini tar- razza cynomolgus, l- effett sedattiv varja minn apatija ħafifa għal inkoxjenza, ikkawżata minn waqa ’ fil- pressjoni tad - demm riversibbli li kienet konnessa mad- doża.
There was increased local haemorrhage at the injection site.
Kien hemm ukoll żjieda lokali fl- emorraġija fil- parti injettata.
Subacute toxicity studies did not reveal any unexpected adverse events.
Studji dwar tossiċità subakuta ma kixfux xi okkorrenzi avversi mhux mixtieqa.
In dogs repeated dosing of the human peptide reteplase led to immunologic-allergic reactions.
Fil- klieb dożaġġ ripetut ta ’ ‘ peptide reteplase ’ umana wassal għal reazzjonijiet immunoloġiċi- allerġiċi.
Genotoxicity of reteplase was excluded by a complete battery of tests at different genetic end points in vitro and in vivo.
Ġenotossiċità ta ’ reteplase kienet eskluża minn sensiela kompleta ta ’ eżamijiet f’ endpoints ġenetiċi in vitro u in vivo differenti.
Reproductive toxicity studies were performed in rats (fertility and embryo-foetotoxicity study including a littering phase) and in rabbits (embryo-foetotoxicity study, dose-range finding only).
8 Studji dwar tossiċità riproduttiva kienu magħmula f’ firien (studju dwar fertilità u embrijo - fetotossiċità li kien jinkludi fażi ta ’ tferrigħ) u fil- fniek (studju dwar embrijo- fetotossiċità, sejba tal - varjazzjoni fid- doża biss).
In rats, a species insensitive to the pharmacological effects of reteplase, there were no adverse effects on fertility, embryo-foetal development and offspring.
Fil- firien, f ’ speċi li hi insensittiva għall- effetti farmakoloġiċi ta ’ reteplase, ma kien hemm l- ebda effetti avversi fuq il- fertilità, l- iżvilupp embrijo- fetali u fuq il- frieħ.
In rabbits, vaginal bleedings and abortions possibly associated to prolonged haemostasis, but no foetal abnormalities were noted.
Fil- fniek, ħruġ tad- demm vaġinali u aborti possibbilment assoċjati ma ’ emostasi fit- tul, kienu osservati, iżda l- ebda anormalitajiet fetali ma kienu osservati.
A pre- and postnatal toxicity study was not performed with reteplase.
Studju dwar it- tossiċità ta ’ qabel u ta ’ wara t- twelid ma sarx b’ reteplase.
Tranexamic acid di potassium-hydrogen phosphate phosphoric acid sucrose Polysorbate 80
Tranexamic acid di- potassum hydrogen phosphate phosphoric acid sucrose Polysorbate 80
This medicinal product should not be mixed with Heparin and/ or acetylsalicylic acid.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ Heparin u/ jew acetylsalicylic acid.
In the absence of compatibility studies with other medicinal products, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti mediċinali li ma jaqblux miegħu, dan il - prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
Heparin and Rapilysin are incompatible when combined in solution.
Eparina u Rapilysin huma inkompatibbli meta mħallta f’ soluzzjoni.
Other incompatibilities may also exist.
Inkompatibilitajiet oħra jistgħu jeżistu wkoll.
No other medicines should be added to the injection solution.
L- ebda medikazzjoni oħra m’ għandha tiżdied mas- soluzzjoni għall- injezzjoni.
Shelf-life as package for sale:
Żmien kemm idum tajjeb il- prodott mediċinali hekk kif ippakkjat għall- bejgħ:
Reconstituted product:
Prodott rikostitwit:
Chemical and physical in-use stability has been demonstrated for 8 hours between 2° and 30 °C after dissolving with water for injection.
Stabbilità kimika u fiżika waqt l- użu ntweriet għal 8 sigħat f’ temperatura ta ’ bejn 2° u 30 °C wara li jinħall fl- ilma għall- injezzjoni.
From a microbiological point of view, the product should be used immediately.
Mill- aspett mikrobijoloġiku, il- prodott għandu jintuża ’ immedjatament.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Jekk ma jintużax immedjatament, il- ħin u l- kondizzjonijiet ta ’ ħażna qabel l- użu huma r- responsabbilità ta ’ minn qed juża ’ l- prodott.
Do not store above 25 °C.
Taħżinx f’ temperatura ’ l fuq minn 25 °C.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikonstitwit, ara sezzjoni 6. 3.
Each pack contains:
Kull pakkett fih:
2 colorless vials of 10 U of powder with a rubber closure 2 prefilled syringes with 10 ml solvent for single use 2 reconstitution Spikes 2 needles 19 G1
2 kunjetti bla kulur b’ 10 U ta ’ trab b’ tapp tal- lasktu 2 siringi mimlija għal lest b’ 10 ml solvent għall- użu ta ’ darba
6.6 Instrucions for use
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu għall- użu u meta jintrema
Incompatibility of some prefilled glass syringes (including Rapilysin) with certain needle free connectors has been reported.
Rapilysin għandu jingħata BISS bis- siringi mimlijin għal- lest ipprovduti.
Therefore, the compatibility of the glass syringe and intravenous access should be ensured before use.
L- użu ta ’ oġġetti oħra jista ’ jwassal għal riskju ta ’ inkompatibilità.
Use aseptic technique throughout.
Użu t- teknika asettika f’ kull parti.
Remove the protective flip-cap from the vial of Rapilysin 10 U and clean the rubber closure with an alcohol wipe.
Neħħi l- għatu protettiv mill- kunjett ta ’ Rapilysin 10 U u naddaf l- għeluq tal- lastku b’ xi ħaġa li timsaħ mxarrba bl- alcoħol.
Open the package containing the reconstitution spike, remove both protective caps from the reconstitution spike.
Iftaħ il- pakkett li fih li ‘ spike ’ għar- rikostituzzjoni, neħħi ż- żewġ għatjien protettivi minn ġo li ‘ spike ’ għar- rikostituzzjoni.
Insert the spike through the rubber closure into the vial of Rapilysin 10 U.
Daħħal li ‘ spike ’ (għatu tal- plastik li jiksi il- kunjett ta ’ Rapilysin) minn ġo l- għeluq tal- lastku fil- kunjett ta ’ Rapilysin 10 U.
Take the 10 ml syringe out of the package.
Oħroġ is- siringa ta ’ 10 ml mill- pakkett.
Remove the tip cap from the syringe.
Neħħi l- għatu ta ’ fuq il- ponta tas- siringa.
Connect the syringe to the reconstitution spike and transfer the 10 ml of solvent into the vial of Rapilysin 10 U.
Ikkonnettja s - siringa ma ’ li ‘ spike ’ għar- rikostituzzjoni u ittrasferixxi l- 10 ml tas- solvent fil- kunjett ta ’ Rapilysin 10 U.
With the reconstitution spike and syringe still attached to the vial, swirl the vial gently to dissolve the Rapilysin 10 U powder.
Bl’ spike għar- rikostituzzjoni u s- siringa għadhom imwaħħlin mal- kunjett, dawwar il- kunjett bil - mod biex tħoll it- trab ta ’ Rapilysin 10 U.
DO NOT SHAKE.
IĊĊAQLAQX.
The reconstituted preparation results in a clear, colourless solution.
Is- soluzzjoni rikostitwita għandha tkun soluzzjoni ċara u bla kulur.
If the solution is not clear and colourless it should be discarded.
Jekk is- soluzzjoni ma tkunx ċara u bla kulur, din għandha tintrema.
Withdraw 10 ml of Rapilysin 10 U solution back into the syringe.
Iġbed 10 ml ta ’ soluzzjoni ta’ Rapilysin 10 U lura ġos- siringa.
A small amount of solution may remain in the vial due to overfill.
Ammont żgħir ta ’ soluzzjoni jista ’ jibqa ’ fil- kunjett minħabba t- tifwir.
Disconnect the syringe from the reconstitution spike.
Aqla s- siringa minn ma ’ l- ispike għar- rikostituzzjoni.
The dose is now ready for intravenous administration
Id- doża issa hija lesta għall- għoti ġol - vini.
The reconstituted solution must be used immediately.
Is- soluzzjoni rikostitwita għandha tintuża minnufih.
Visual inspection of the solution is necessary after reconstitution.
Spezzjoni viżwali tas- soluzzjoni hija neċessarja wara r- rikostituzzjoni.
Only clear, colourless solutions should be injected.
Soluzzjonijiet ċari u bla kulur biss għandhom jiġu njettati.
If the solution is not clear and colourless it should be discarded.
Jekk is- soluzzjoni mhix ċara u bla kulur din għandha tintrema.
No other medicines should be injected through the line reserved for Rapilysin either at the same time, or prior to, or following Rapilysin injection.
L- ebda mediċina oħra m’ għandha tiġi njettata minn ġol- pajp riservat għal Rapilysin, la fl- istess ħin, la qabel, u lanqas wara l- injezzjoni ta ’ Rapilysin.
This applies to all products including heparin and acetylsalicylic acid, which should be administered before and following the administration of reteplase to reduce the risk of re-thrombosis
Dan japplika għall- prodotti kollha inkluż eparina, u acetylsalicylic acid, li għandhom jingħataw qabel u wara l- għotja ta ’ reteplase biex inaqqsu r- riskju ta ’ trombożi mill- ġdid.
In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9% sodium chloride or 5% dextrose solution prior to and following the Rapilysin injection (see section 4.2 Posology and method of administration).
F’ dawk il- pazjenti fejn irid jintuża l- istess pajp, dan il- pajp (inkluż il- pajp- Y), għandu jiġi mlaħlaħ sew b’ soluzzjoni ta ’ 0. 9% sodium chloride jew 5% dextrose qabel u wara injeżżjoni ta ’ Rapilysin (ara sezzjoni 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata).
Precaution for disposal:
Prekawzjoni għar- rimi:
Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjordur Iceland.
Reykjavikurvegi 76- 78 220 Hafnarfjordur Islanda
29 August 1996 Date of last renewal:
29 ta ’ Awissu 1996 Data ta ’ l- aħħar tiġdid:
29 August 2006
29 ta ’ Awissu 2006
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA BIJOLOĠIKAATTIVA U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Name and address of the manufacturer of the biological active substance
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Roche Diagnostics GmbH Nonnenwald 2 82377 Penzberg Germany
Roche Diagnostics GmbH Nonnenwald 2 82377 Penzberg Il- Ġermanja
Cenexi 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois France
Cenexi 52, Rue Marcel et Jacques Gaucher 94120 Fontenay- Sous- Bois Franza
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L -- AWTORIZZAZZJONI GĦAT- TQEGĦID FUQ IS- SUQ
LABELLING
TIKKETTA U L- FULJETT FIL- PAKKETT
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND, THE IMMEDIATE PACKAGING
TIKKETTA
Rapilysin 10 U powder and solvent for solution for injection Water for injections for Rapilysin 10 U solution for intravenous use
Rapilysin 10 U trab u solvent għas- soluzzjoni għall- injezzjoni Ilma għall- injezzjonijiet għal soluzzjoni Rapilysin 10 U għal użu ġol- vini
Reteplase 10 U (recombinant plasminogen activator, thrombolytic agent)
Reteplase 10 U (attivatur rikombinanti ta ’ plażminoġen, aġent trombolitiku)
Tranexamic acid di potassium-hydrogen phosphate phosphoric acid sucrose Polysorbate 80
Trab: Tranexamic acid di- potassium hydrogen phosphate phosphoric acid sucrose Polysorbate 80 Solvent: ilma għall- injezzjonijiet.
Powder and solvent for injection (contains 2x [0.56 g of powder in a vial and 10 ml solvent in a pre- filled syringe with reconstitution spike and needle])
Trab u solvent għall- injezzjoni (fiħ 2x [0. 56 g ta ’ trab f’ kunjett u 10 ml ta ’ solvent f’ siringa mimlija għal lest bi spike għar- rikostituzzjoni u labra])
Intravenous use Read the package leaflet before use.
Għall- użu ġol- vini Aqra l- fuljett ta ’ tagħrif qabel l- użu
Keep out of the reach and sight of children
Żomm fejn ma jintlaħaqx u fejn ma jidhirx mit- tfal
Use the solution immediately after reconstitution
Uża s- soluzzjoni minnufih wara r- rikostituzzjoni
Do not store above 25 °C Keep the vial in the outer carton in order to protect from light
Taħżinx f’ temperatura ’ l fuq minn 25 °C Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
LABEL OF THE VIAL
TIKKETTA TAL- KUNJETT
Rapilysin 10 U powder and solvent for solution for injection Reteplase Intravenous use
Rapilysin 10 U trab u solvent għal soluzzjoni għall- injezzjoni Reteplase użu għal ġol- vini
10 U reteplase
reteplase10 U
LABEL OF THE SYRINGE
TIKKETTA TAS- SIRINGA
19 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
INFORMATION FOR THE USER Rapilysin 10 U powder and solvent for solution for injection reteplase
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Rapilysin 10 U trab u solvent għal soluzzjoni għall- injezzjoni Reteplase
Read all of this leaflet carefully before you start using this medicine
Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina
What Rapilysin is and what it is used for 2.
X’ inhu Rapilysin u għalxiex jintuża 2.
Before the doctor gives you Rapilysin 3.
Qabel ma tuża Rapilysin 3.
How to use Rapilysin 4.
Kif għandek tuża Rapilysin 4.
How to store Rapilysin 6.
Kif taħżen Rapilysin 6.
WHAT RAPILYSIN IS AND WHAT IT IS USED FOR
X’ INHU RAPILYSIN U GĦALXIEX JINTUŻA
Rapilysin (a recombinant plasminogen activator) is a thrombolytic medicine used to dissolve blood clots that have formed in certain blood vessels and to restore the blood flow in these blocked vessels (=thrombolysis).
Rapilysin (attivatur rikombinanti ta ’ plażminoġen) huwa mediċina trombolitika użata biex tħoll l - emboli li jkunu ffurmaw f’ ċerti vini u arterji tad- demm u biex treġġa ’ lura għan- normal iċ - ċirkolazzjoni tad- demm f’ dawn il- vini u l- arterji imblukkati (=tromboliżi).
Rapilysin is used after an acute myocardial infarction (heart attack) in order to dissolve the blood clot causing the heart attack.
Rapilysin huwa użat wara infart mijokardjali akut (attakk tal- qalb) sabiex iħoll l- embolu li jikkawża l - attakk tal- qalb.
It is given within 12 hours after the onset of symptoms.
Huwa mogħti fi żmien 12- il siegħa wara l- bidu tas- sintomi.
BEFORE YOU USE RAPILYSIN
QABEL MA TUŻA RAPILYSIN
The doctor will ask you questions before giving you Rapilysin, to find out if you have an increased risk of bleeding.
It- tabib għandu jistaqsik xi mistoqsijiet qabel jagħtik Rapilysin, biex jiskopri jekk inti għandekx riskju għoli ta ’ ħruġ tad- demm.
Do not use Rapilysin:
Tużax Rapilysin:
Before treatment with Rapilysin, make sure your doctor knows if you
Qabel kura b’ Rapilysin, kun ċert li t- tabib tiegħek jaf jekk int
• are allergic (hypersensitive) to reteplase or any of the other ingredients of Rapilysin
• allerġiku/ a (tbagħti minn sensittività eċċessiva) għal reteplase jew sustanzi oħra ta ’ Rapilysin
• have a bleeding disorder
• għandek mard tal- ħruġ tad- demm
• are taking medicine to thin your blood (oral anticoagulants, e. g. warfarin)
• qed tieħu mediċina biex traqqaq id- demm (mediċina meħuda mill- ħalq kontra t- tagħqid tad - demm, eż. warfarin)
• have a brain tumour or a malformed blood vessel or a vessel wall dilatation (aneurysm) in the brain
• għandek tumur fil- moħħ jew f’ xi vina jew f’ xi arterja tad- demm deformata jew twessigħ f’ xi vina jew f’ xi arterja (anewriżma) fil- moħħ
• have other tumours associated with an increased risk of bleeding
• għandek tumuri oħra assoċjati ma ’ riskju għoli ta ’ ħruġ tad- demm
• have had a stroke
• kellek xi puplesija
• have had external heart massage within the past 10 days
• kellek massaġġ tal- qalb estern fl- aħħar 10 t’ ijiem
• have severe uncontrolled high blood pressure (hypertension)
• għandek pressjoni tad- demm għolja serja mhux ikkontrollata (ipertensjoni)
• have an ulcer in the stomach or small intestine
• għandek xi ulċera fl- stonku jew fil- musrana ż- żgħira
• have enlarged blood vessels in the gullet (oesophagus) (frequently caused by liver disease)
21 • għandek tkabbir fil- vini u fl- arterji tad- demm fil- gerżuma ta ’ l- ikel (esofagu) (spiss ikkawżat minn mard tal- fwied)