qanastek/EMEA-V3 huggingface dataset:
It is strongly recommended that every time EVICEL is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Huwa rrakkomandat bil- qawwa li kull darba li EVICEL jingħata lil pazjent, l- isem u n- numru tal- lott jiġu ddokumentati sabiex tinżamm rabta bejn il- pazjent u l- lott tal- prodott.
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 affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
No formal interaction studies have been performed.
Ma sar l- ebda studju formali ta 'interazzjoni.
Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing alcohol, iodine or heavy metals (e. g. antiseptic solutions).
Simili għall- prodotti komparabbli jew soluzzjonijiet ta 'trombina, il- prodott jista' jkun denaturat wara esponiment għal soluzzjonijiet li fihom l- alkoħol, jodju jew metalli tqal (eż. soluzzjonijiet antisettiċi).
Such substances should be removed to the greatest possible extent before applying the product.
Sustanzi bħal dawn għandhom jitneħħew kemm jista 'jkun qabel ma jiġi applikat il- prodott.
4.6 Pregnancy and lactation
3 4. 6 Tqala u Treddigħ
3 The safety of fibrin sealants/ haemostatics for use in human pregnancy or during breast-feeding has not been established in controlled clinical trials.
Is- sigurtà ta 'siġillanti/ emostatiċi li fihom il- fibrina għall- użu fit- tqala umana jew waqt it- treddigħ ma ġietx stabbilita fi provi kliniċi kkontrollati.
Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and post-natal development.
Studji sperimentali fl- annimali mhumiex biżżejjed biex jivvalutaw is - sigurtà fir- rigward tar- riproduzzjoni, żvilupp ta 'l- embriju jew fetu, il- kors ta' ġestazzjoni u żvilupp perinatali u postnatali (madwar u wara t- twelid).
Therefore, the product should be administered to pregnant and lactating women only if clearly needed.
Għaldaqstant, il- prodott għandu jingħata lil nisa tqal u li qegħdin irreddgħu biss jekk dan ikun meħtieġ b' mod ċar.
Not relevant.
Mhux rilevanti.
Adverse reactions which may be reported in association with fibrin sealants are described below.
Hawn taħt jiġu deskritti r- reazzjonijiet avversi li jistgħu jiġu rrappurtati flimkien b' siġillanti abbażi tal- fibrina.
Since no such reactions have been reported during clinical trials with EVICEL, the frequency of these events with EVICEL is not known.
Billi l- ebda reazzjoni bħal din ma ġiet irrappurtata matul il- provi kliniċi b' EVICEL, mhijiex magħrufa l - frekwenza ta 'dawn l- episodji b' EVICEL.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealants/ haemostatics.
Rarament dawn ir- reazzjonijiet jistgħu jseħħu f' pazjenti ttrattati bis- siġillanti abbażi tal- fibrina/ emostatiċi: ipersensittività jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedema, ħruq u tingiż fil- punt ta 'applikazzjoni, bronkospażmi, tertir, ħmura fil- wiċċ, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, ipotensjoni, letarġija, nawżea, nuqqas ta 'sabar, takikardija, għafis tas- sider, tnemnim, remettar, nifs bit - tħarħir).
In isolated cases, these reactions have progressed to severe anaphylaxis.
F' każijiet iżolati, dawn ir- reazzjonijiet iddeġeneraw f' anafilassi gravi.
Such reactions may especially be seen if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to constituents of the product.
Dawn ir- reazzjonijiet jistgħu jkunu osservati jekk il- preparazzjoni hija applikata ripetutament, jew mogħtija lill- pazjenti magħrufa li huma ipersensittivi għall- komponenti tal- prodott.
Mild reactions can be managed with anti-histamines.
Huwa possibbli li r- reazzjonijiet il- ħfief jiġu kkontrollati permezz ta 'mediċini antistaminiċi.
Severe hypotensive reactions require immediate intervention using current principles of shock therapy.
Ir- reazzjonijiet ipotensivi gravi jeħtieġu intervent immedjat bl- użu tal- prinċipji attwali tat- terapija tax- xokkijiet.
Antibodies against components of fibrin sealant/ haemostatic products may occur rarely.
F' każijiet rari jistgħu jiġu żviluppati antikorpi kontra l- komponenti tal- prodotti li fihom siġillant abbażi tal - fibrina/ emostatiċi.
Inadvertent intravascular injection could lead to thromboembolic event and DIC, and there is also a risk of anaphylactic reaction (see 4.4).
L- injezzjoni intravaskulari aċċidentali tista 'twassal għal episodji tromboemboliċi jew koagulazzjoni intravaskulari disseminata (DIC), u barra dan jeżisti r- riskju ta' reazzjoni anafilattika (ara 4. 4)
For safety with respect to transmissible agents, see 4.4.
Ara 4. 4 għas- sigurtà fir- rigward ta 'l- aġenti trasmissibbli.
The following adverse events which occurred during clinical studies were evaluated as having a possible causal relationship to treatment with EVICEL.
Dawn l- episodji avversi li dehru matul l- istudji kliniċi ġew evalwati bħala episodji li għandhom relazzjoni kawżali possibbli mat- trattament b' EVICEL.
The frequency of all of the events listed below was common (defined as > 1/ 100, < 1/ 10).
Il- frekwenza ta 'l- episodji elenkati hawn taħt kienet komuni (definiti bħala > 1/ 100, < 1/ 10).
MedDRA System Organ Class
Terminu preferut Klassi sistemiko- organika MedDRA Reazzjonijiet avversi fl- istudju dwar l- interventi retroperitoneali jew intraddominali Infezzjonijiet u infestazzjonijiet
Preferred Term
Axxess addominali
Adverse Reactions in Retroperitoneal or Intra-Abdominal Surgery Study Infections and infestations Adverse Reactions in Vascular Surgery Study
Reazzjonijiet avversi fl- istudju dwar il- kirurġija vaskulari Infezzjonijiet u infestazzjonijiet
Abdominal abscess
Infezzjoni tat - trapjant (graft), infezzjoni minn stafilokokku
Infections and infestations Vascular disorders General disorders and administration site conditions
Disturbi vaskulari Disturbi ġenerali u kundizzjonijiet fil- punt mnejn tingħata l- mediċina
Graft infection, Staphylococcal infection Haematoma Oedema peripheral
Ematoma Edema periferika
Investigations Injury, Poisoning and Procedural Complications
Analiżijiet Leżjonijiet, avvelenament jew
Decreased haemoglobin Incision site haemorrhage Vascular graft occlusion Wound Post procedural haematoma Post-operative wound complication
Emoglobina mnaqqsa Emorraġija fil- punt ta 'inċiżjoni
Among 135 patients undergoing retroperitoneal and intra-abdominal surgery (67 patients treated with EVICEL and 68 controls), no adverse events were considered to be causally related to the study treatment according to the investigator assessments.
Fost il- 135 pazjent sottoposti għal intervent kirurġiku retroperitoneali u intraddominali (67 pazjent ittrattati b' EVICEL u 68 kontroll), fuq il- bażi ta 'valutazzjonijiet ta' l- investigatur, l- ebda episodju avvers ma ntqiesx marbut kawżalment mat- trattament ta 'studju.
However, 3 serious adverse events (SAE) (one abdominal abscess in the EVICEL group and one abdominal and one pelvic abscess in the control group) were considered by the Sponsor to be possibly related to study treatment.
Madankollu, l- isponsor qies tliet episodji avversi gravi (axxess addominali fil- grupp b' EVICEL u axxess addominali u ieħor pelviku fil- grupp ta 'kontroll) possibbilment marbutin mat- trattament ta' studju.
Adverse Reactions - Vascular Surgery
Reazzjonijiet avversi - kirurġija vaskulari
In a controlled study involving 147 patients undergoing vascular grafting procedures (75 treated with EVICEL and 72 controls), a total of 16 subjects were reported to have had a graft thrombosis/ occlusion adverse event during the study period.
Fi studju kontrollat fuq 147 pazjent sottoposti għal proċeduri ta 'trapjant (grafting) vaskulari (75 ittrattati b' EVICEL u 72 kontroll), ġew irrappurtati total ta' 16- il pazjent b' episodju avvers ta 'trombożi/ okklużjoni tat - trapjant (graft) matul l- istudju.
The events were evenly distributed across treatment arms, with 8 each in the EVICEL and the control groups.
L- episodji rriżultaw distribwiti uniformement bejn il- fergħat tat- trattament, b' kull wieħed mit- 8 episodji fil- grupp ittrattat b' EVICEL u fil- grupp ta 'kontroll.
No case of overdose has been reported.
Ma ġie rrapportat l- ebda każ ta 'doża eċċessiva.
Pharmacotherapeutic group: local haemostatics, ATC code:
Kategorija farmakoterapewtika: emostatiċi lokali, Kodiċi ATC:
The fibrin adhesion system initiates the last phase of physiological blood coagulation.
Is- sistema ta 'adeżjoni li fiha l- fibrina tagħti bidu għall- aħħar fażi tal- koagulazzjoni fiżjoloġika tad- demm.
Conversion of fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides.
Il - konverżjoni ta 'fibrinoġen f' fibrina sseħħ bil- qsim ta' fibrinoġen f' monomeri ta 'fibrina u fibrinopeptidi.
The fibrin monomers aggregate and form a fibrin clot.
Il - monomeri ta 'fibrina jaggregaw u jifformaw fibrina magħquda.
Factor XIIIa, which is activated form Factor XIII by thrombin, crosslinks fibrin.
Il- Fattur XIIIa, li huwa forma attivata tal - Fattur XIII minn trombina, jagħmel crosslinkages ma 'fibrina.
Calcium ions are required for both, the conversion of fibrinogen and the crosslinkage of fibrin.
Joni tal- kalċju huma meħtieġa għat- tnejn, il - konverżjoni ta 'fibrinoġen u l- crosslinkage ta' fibrina.
As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.
Hekk kif il- fejqan tal- ferita javvanza, żieda fl- attività fibrinolitika hija indotta mill- plażmina u tinbeda d - dekompożizzjoni ta 'fibrina fi prodotti ta' degradazzjoni tal- fibrina.
Clinical studies demonstrating haemostasis and suture support were conducted in a total of 147 patients (75 with EVICEL, 72 with control) undergoing vascular surgery with PTFE grafts and in a total of 135 patients (66 with EVICEL, 69 with control) undergoing retroperitoneal and intra- abdominal surgery.
Studji kliniċi li juru emostażi u appoġġ tas- sutura saru f' total ta '147 pazjent (75 b' EVICEL, 72 bil- kontroll) sottoposti minn kirurġija vaskulari bi trapjanti PTFE u f' total ta' 135 pazjent (66 b' EVICEL, 69 bil- kontroll) sottoposti għal kirurġija retroperitoneali u intraddominali.
Data are too limited to support the safety and effectiveness of EVICEL in children.
Id- dejta hija limitata wisq biex tappoġġja s- sigurtà u l- effikaċja ta 'EVICEL fit- tfal.
Of 135 patients undergoing retroperitoneal and intra-abdominal surgery who were included in the controlled study of EVICEL, 4 patients treated with EVICEL were aged 16 years or younger.
Minn 135 pazjent sottoposti għal kirurġija retroperitoneali u intraaddominali li kienu inklużi fl- istudju kkontrollat ta 'EVICEL, 4 pazjenti ttrattati b' EVICEL kienu ta' età ta '16- il sena jew iżgħar.
Of these, 2 were children aged 2 and 5 years and 2 were adolescents of 16 years.
Minn dawn, 2 kienu tfal ta 'etajiet 2 u 5 snin u 2 kienu adolexxenti ta' 16- il sena.
No data are currently available for ages younger than 2 years.
5. 2 Tagħrif farmakokinetiku
EVICEL is intended for epilesional use only.
EVICEL huwa intenzjonat għal użu epileżjonali biss.
Intravascular administration is contraindicated.
Għoti intravaskulari huwa kontraindikat.
As a consequence, intravascular pharmacokinetic studies were not performed in man.
Bħala konsegwenza, studji farmakokinetiċi intravaskulari ma sarux fil- bniedem.
Studies have been conducted in rabbits to evaluate the absorption and elimination of thrombin when applied to the cut surface of the liver resulting from partial hepatectomy.
Saru studji fil- fniek biex jevalwaw l- assorbiment u l- eliminazzjoni ta 'trombina meta applikat mal- wiċċ maqtugħ tal- fwied li jirriżulta minn epatektomija parzjali.
Using 125I-thrombin it was shown that a slow absorption of biologically inactive peptides resulting from the breakdown of thrombin occurred, reaching a Cmax in the plasma after 6-8 hours.
Permezz ta 'l- użu ta' 125I- trombina ntwera li seħħ assorbiment bil- mod ta 'peptidi bijoloġikament innattivi li jirriżultaw minn tkissir ta' trombina, li laħaq Cmax
At the Cmax, the plasma concentration represented only 1-2% of the applied dose.
Fis- Cmax, il- konċentrazzjoni tal- plażma rrappreżentat biss 1- 2% tad- doża applikata.
Fibrin sealants/ haemostatics are metabolised in the same way as endogenous fibrin, by fibrinolysis and phagocytosis.
Is- siġillanti/ l- emostatiċi abbażi tal- fibrina huma metabolizzati fl- istess mod ta 'fibrina endoġena, permezz ta' fibrinoliżi u fagoċitożi.
5 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Studies performed in bacteria to determine mutagenicity were negative for Thrombin alone, Biological Active Component (containing fibrinogen, citrate, glycine, tranexamic acid, and arginine hydrochloride), TnBP alone, and Triton X-100 alone at all concentrations tested.
Studji magħmulin fil- batterji biex jiddeterminaw il- mutaġeniċità kienu negattivi għat- Trombina waħedha, Komponent Bijoloġikament Attiv (li fih fibrinoġen, ċitrat, gliċina, aċidu traneksamiku, u arġinina- kloridrat), TnBP waħdu, u Triton X- 100 waħdu fil- konċentrazzjonijiet kollha ttestjati.
All concentrations of the combination of TnBP and Triton X-100 also tested negative in assays performed to determine mammalian cell mutageneicity, chromosomal aberrations and micronuclei induction.
Il- konċentrazzjonijiet kollha tal - kombinazzjoni ta 'TnBP u Triton X- 100 ukoll ittestjaw negattivi f' assaġġi magħmulin biex jiddeterminaw mutaġeniċità ta' ċelloli mammiferi, aberrazzjonijiet kromożomiċi u induzjoni ta 'mikronukleji.
After local application, absorption of thrombin into the plasma is slow and consists principally of thrombin degradation products which are eliminated.
Wara applikazzjoni lokali, l- assorbiment ta 'trombina għal ġewwa l- plażma jsir bil- mod u jikkonsisti prinċipalment minn prodotti ta' degradazzjoni ta 'trombina li huma eliminati.
No toxicological effects due to the solvent detergent reagents (TnBP and Triton X-100) used in the virus inactivation procedure are expected since the residual levels are less than 5 µg/ ml.
L- ebda effett tossikoloġiku minħabba reaġenti deterġenti solventi (TnBP u Triton X- 100) użati fil- proċedura ta 'inattivazzjoni tal- virus ma huma mistennija peress li livelli reżidwi huma inqas minn 5 µg/ ml.
Neurotoxicity studies performed with EVICEL confirmed that subdural administration in the rabbit was not associated with any evidence of neurotoxicity.
Studji ta 'newrotossiċità magħmulin b' EVICEL ikkonfermaw li għoti sottodurali fil- fniek ma kienx assoċjat ma' xi evidenza ta 'newrotossiċità.
Neurobehavioral observations for 14±1 days showed no abnormal findings.
Osservazzjonijiet ta 'mġiba newroloġika għal 14±1 jum ma wrew l- ebda anomalija.
No major macroscopic signs of local intolerance and no treatment – related macroscopic findings were observed.
Ma kienu osservati l- ebda sinjali makroskopiċi maġġuri ta 'intolleranza lokali u l- ebda riżultat makroskopiku relatati mat- trattament.
Analysis of cerebrospinal fluid did not reveal major signs of inflammation.
Analiżi ta 'fluwidu ċerebrospinali ma weriex sinjali maġġuri ta' infjammazzjoni.
6.1 List of excipients
6. 1 Lista ta 'eċċipjenti
Human fibrinogen vial:
Kunjett li fih il- fibrinoġen uman:
Arginine hydrochloride Glycine Sodium chloride Sodium citrate Calcium chloride Water for injections
Arġinina kloridrat Gliċina Klorur tas- sodju Ċitrat tas- sodju Klorur tal- kalċju Ilma għall- injezzjonijiet
Human thrombin vial:
Kunjett tat- trombina umana:
Calcium chloride Human albumin Mannitol Sodium acetate Water for injections
Klorur tal- kalċju Albumina umana Mannitol Sodju aċetat Ilma għall- injezzjonijiet
Each ml contains 11.6-12.9 mg sodium.
Kull ml fih 11. 6- 12. 9 mg sodju.
6.4 Special precautions for storage
Dan il- prodott m' għandux jitħallat ma 'prodotti mediċinali oħrajn.
Store in a freezer at or below -18 C.
Aħżen fi friżer fi jew taħt - 18C.
Keep the vials in the outer carton in order to protect from light.
Żomm il- kunjetti fil- kartuna ta 'barra sabiex tilqa' mid- dawl.
Do not refreeze.
Terġax tiffriża.
After thawing, unopened vials can be stored at 2-8 C and protected from light, for up to 30 days, without being frozen again during this period.
6 Wara li jkunu nħallu (dab is- silġ kollu tagħhom), il- kunjetti mhux miftuħin jistgħu jinħażnu fi 2 – 8C u protetti mid- dawl, sa 30 jum, mingħajr ma jerġgħu jiġu ffriżati mill- ġdid matul dan il- perjodu.
The new expiry date at 2-8 C should be noted on the carton.
Id- data ta 'l - iskadenza l- ġdida fi 2- 8C għandha tkun miktuba fuq il- pakkett.
At the end of this period the product has to be used or discarded.
Fi tmiem dan il- perjodu, il- prodott irid ikun intuża jew jintrema.
The Fibrinogen and Thrombin components are stable at room temperature for up to 24 hours but once drawn up into the application device, they must be used immediately.
Il- komponenti ta 'Fibrinoġen u Trombina huma stabbli f' temperatura ambjentali sa 24 siegħa iżda ladarba jkunu nġibdu fl- apparat ta' l- applikazzjoni, għandhom jintużaw minnufih.
6 6.5 Nature and contents of container
6. 5 Natura tal- kontenitur u tal- kontenut
EVICEL is supplied as a package containing two separate vials (glass type I) with rubber stoppers (type I), each containing 1 ml, 2 ml or 5 ml solution of Human Fibrinogen and Human Thrombin, respectively.
EVICEL huwa fornut bħala pakkett li fih żewġ kunjetti separati (ħġieġ tip I) b' tappijiet tal- lastku (tip I), li kull wieħed fih 1 ml, 2 ml jew 5 ml soluzzjoni ta 'Fibrinoġen u Trombina rispettivament.
An application device and appropriate accessory tips are supplied separately.
L- apparat ta 'applikazzjoni u truf ta' aċċessorji addattati huma fornuti separatament.
6.6 Instructions for use, handling and disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
The instructions for use are also described in the healthcare professionals package leaflet part.
L- istruzzjonijiet għall- użu huma deskritti wkoll fil- parti tal- fuljett ta 'tagħrif indirizzata lill- professjonisti tal - kura tas- saħħa.
 Thawing:
 Taħlil mis- silġ:
The vials should be thawed in one of the following ways:
Il- kunjetti għandhom jinħallu mis- silġ b' wieħed minn dawn il- modi:
2-8°C (refrigerator): vials thaw within 1 day, or 20-25°C (room temperature): vials thaw within 1 hour, or 37ºC (e. g. water bath, using aseptic technique, or by warming vials in the hand): vials should be thawed within 10 minutes and must not be left at this temperature for longer than 10 minutes or until fully thawed.
2- 8°C (friġġ): il- kunjetti jinħallu mis- silġ fi żmien jum, jew 20- 25°C (temperatura ambjentali): il- kunjetti jinħallu mis- silġ fi żmien siegħa, jew 37ºC (eż:, banju marija, bl- użu ta 'teknika asettika, jew billi l- kunjetti jissaħħnu fl- id): il- kunjetti għandhom jinħallu mis- silġ fi żmien 10 minuti u jeħtieġ li ma jitħallewx f' din it- temperatura għal iktar minn 10 minuti, jew sakemm jinħallu mis- silġ kompletament.
The temperature must not exceed 37ºC.
It- temperatura m' għandhiex taqbeż 37ºC.
Before use, the product must reach 20-30°C.
Qabel l- użu, il- prodott jeħtieġ jilħaq 20- 30°C.
 Preparation
 Preparazzjoni
The solutions are clear or slightly opalescent.
Is- soluzzjonijiet huma ċari jew xi ftit opalexxenti.
Do not use solutions that are cloudy or have deposits.
Tużax soluzzjonijiet li huma mdardrin jew li jkollhom depożiti.
EVICEL should be applied using the CE-marked EVICEL application device and optional use of a tip accessory to the device.
EVICEL għandu jiġi applikat permezz ta 'l- użu ta' apparat ta 'applikazzjoni EVICEL immarkat- CE u l- użu mhux obbligatorju ta' ponta aċċessorja għall- apparat.
Leaflets giving detailed instructions for use of EVICEL in conjunction with the application device and optional accessory are provided with the package of the application device and of the accessory.
Fuljetti li jagħtu struzzjonijiet iddettaljati għall- użu ta 'EVICEL flimkien ma' l- apparat ta 'applikazzjoni u aċċessorju mhux obbligatorju huma pprovduti mal - pakkett ta' l- apparat ta 'l- applikazzjoni u ta' l- aċċessorju.
Draw the contents of the two vials into the application device, following the instructions for use in the device package.
Iġbed il- kontenuti taż- żewġ kunjetti għal ġewwa l- apparat ta 'l- applikazzjoni, billi ssegwi l- istruzzjonijiet għall- użu fil- pakkett ta' l- apparat.
Both syringes should be filled with equal volumes, and should not contain air bubbles.
Iż- żewġ siringi għandhom jimtlew b' volumi indaqs, u m' għandhomx ikollhom bżieżaq ta 'l- arja.
No needles are involved in the preparation of EVICEL for administration.
L- ebda labar ma huma nvoluti fil- preparazzjoni ta 'EVICEL għal l- għoti.
 Application by dripping
 Applikazzjoni permezz ta 'taqtir
Keeping the tip of the applicator as close to the tissue surface as possible, but without touching the tissue during application, apply individual drops to the area to be treated.
Billi żżomm it- tarf ta 'l- applikatur qrib kemm jista' jkun possibbli mal- wiċċ tat- tessut, iżda mingħajr ma tmiss it- tessut waqt l- applikazzjoni, applika taqtir individwali lill- erja li trid tiġi ttrattata.
If the applicator tip becomes blocked, the catheter tip can be cut back in 0.5 cm increments.
Jekk it- tarf ta 'l- applikatur jimblokka, it- tarf tal- katiter jista' jinqata 'f' inkrimenti ta' 0. 5 ċm.
 Spray application
 Applikazzjoni bħala sprej
EVICEL can be sprayed using pressurized CO2 or compressed air.
EVICEL jista 'jiġi sprejjat bl- użu ta' CO2 taħt pressjoni jew arja kkumpressata.
Connect the short tube on the application device to the male luer-lock end of the long gas tube.
7 Qabbad it- tubu l- qasir fuq l- apparat ta 'l- applikazzjoni mat- tarf tal- lukkett luwer male tat- tubu t- twil tal- gass.
Connect the female luer lock of the gas tube (with the 0.2 μ m bacteriostatic filter) to a pressure regulator capable of delivering 1.0 to 2.0 bars pressure.
Qabbad il- lukkett luwer female tat- tubu tal- gass (mal- filtru 0. 2 μm batterjostatiku) mar- regolatur tal - pressjoni kapaċi li jwassal pressjoni ta '1. 0 sa 2. 0 bars.
The pressure regulator should be used in accordance with the manufacturer’ s instructions.
Ir- regolatur tal- pressjoni għandu jintuża skond l - istruzzjonijiet tal- manifattur.
A pressure of 1.4 to 1.7 bars (measured by gas flow) should be used for spraying.
Pressjoni ta '1. 4 sa 1. 7 bars (imkejla permezz tat- tnixxija tal- gass) għandha tintuża għall- isprejjar.
The distance between the nozzle and the tissue surface should ideally be 10 to 15 cm.
Id- distanza bejn iż- żennuna u l- wiċċ tat- tessut idejalment għandha tkun 10 sa 15- il ċm.
The product should then be sprayed onto the surface of the tissue in short bursts (0.1-0.2 ml) to form a thin, even layer.
Imbagħad, il- prodott għandu jkun sprejjat fuq il- wiċċ tat- tessut fi splużjonijiet qosra (0. 1- 0. 2 ml) biex ikun ifformat saff indaqs, irqiq.
EVICEL forms a clear film over the area of application.
EVICEL jifforma rita ċara fuq l- erja ta 'l- applikazzjoni.
200 Chaussée de Waterloo B-1640 Rhode-St-Genèse Belgium Tel: +32 2 359 91 23 Fax: +32 2 359 91 49
200 Chaussée de Waterloo B- 1640 Rhode- St- Genèse Il- Belġju Tel: +32 2 359 91 23 Fax: +32 2 359 91 49
DATE OF REVISION OF THE TEXT
DATA TA 'REVIŻJONI TAT- TEST
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq is- sit ta 'l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIOLOĠIKA ATTIVA U DETENTUR TA 'L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIOLOĠIKA ATTIVA U DETENTUR TA 'L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer of the biological active substance
Isem u indirizz tal- manifattur tas- sustanza bioloġika attiva
MDA Blood Bank Sheba Hospital Ramat Gan 52621 POB 888 Kiryat Ono 55000 Israel
MDA Blood Bank Sheba Hospital Ramat Gan 52621 POB 888 Kiryat Ono 55000 L- Iżrael
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli mill- ħruġ tal- lott
200 Chaussée de Waterloo 1640 Rhode-St-Genèse Belgium
200 Chaussée de Waterloo 1640 Rhode- St- Genèse Il- Belġju
 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 FIS- SUQ
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali soġġett għal riċetta ristretta tat- tabib (Ara Anness I:
Summary of Product Characteristics, section 4.2).
Sommarju tal- Karatteristiċi tal - Prodott, Sezzjoni 4. 2)
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TAS- SIGURTÀ U L - UŻU EFFIKAĊI TAL- PRODOTT MEDIĊINALI
Not applicable
Mhux applikabbli.
 OTHER CONDITIONS
 KUNDIZZJONIJIET OĦRAJN
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version J/ 11-01-03 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta 'farmakoviġilanza Id- Detentur ta' l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jassigura li s- sistema ta 'farmakoviġilanza, hekk kif deskritta fil- verżjoni J/ 11- 01- 03 ppreżentata fil- Modulu 1. 8. 1 ta' l- Applikazzjoni għall - Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun fis- seħħ u tiffunzjona qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version J/ 11-00-03 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta 'Ġestjoni tar- Riskji Id- Detentur ta' l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu sabiex iwettaq l- istudji u l- attivitajiet addizzjonali ta 'farmakoviġilanza deskritti fil- Pjan ta' Farmakoviġilanza, kif maqbul fil- verżjoni J/ 11- 00- 03 tal- Pjan ta 'Ġestjoni tar- Riskji (RMP) ippreżentat fil- Modulu 1. 8. 2 ta' l- Applikazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti ta 'l- RMP kif ġie maqbul mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji gwida tas- CHMP dwar is- Sistemi ta 'Ġestjoni tar- Riskju għall- prodotti mediċinali għall- użu mill- bniedem, l- RMP aġġornat għandu jiġi ppreżentat flimkien ma' l- Aġġornament Perjodiku fil- qasam tas - Sigurtà (PSUR) li jmiss.
In addition, an updated RMP should be submitted  When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Barra minn hekk, għandu jitressaq ukoll RMP aġġornat:  Meta tidħol informazzjoni ġdida li jista 'jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà fis- seħħ, fuq il- Pjan ta' Farmakoviġilanza jew fuq l- attivitajiet ta 'minimizzazzjoni tar- riskju;  Fi żmien 60 jum ta' meta għandu jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju).
10  Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached  At the request of the EMEA
10  Fuq talba ta 'l- EMEA.
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ uffiċjali tal- lottijiet: skond l- Artikolu 114 tad- Direttiva 2001/ 83/ KE kif emendata, il- ħruġ uffiċjali tal - lottijiet isir minn laboratorju ta 'l- Istat jew minn laboratorju destinat għal dan l- iskop.
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
13 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTUNA TA 'BARRA
Carton box containing 2 vials
Pakkett li fih 2 kunjetti
EVICEL solutions for sealant
EVICEL soluzzjonijiet ta 'siġillant
Solutions for sealant
Soluzzjonijiet ta 'siġillant
The active substances are as follows:
Is- sustanzi attivi huwa dawn li ġejjin:
1 vial containing 1 ml of human thrombin (800 – 1200 IU/ ml).
Komponent 1: kunjett li fih 1 ml proteina umana li tgħaqqad (50 – 90 mg/ ml) Komponent 2: kunjett li fih 1 ml trombina umana (800 – 1200 IU/ ml).
1 vial containing 2 ml of human thrombin (800 – 1200 IU/ ml).
Komponent 1: kunjett li fih 2 ml proteina umana li tgħaqqad (50 – 90 mg/ ml) Komponent 2: kunjett li fih 2 ml trombina umana (800 – 1200 IU/ ml).
1 vial containing 5 ml of human thrombin (800 – 1200 IU/ ml).
Komponent 1: kunjett li fih 5 ml proteina umana li tgħaqqad (50 – 90 mg/ ml) Komponent 2: kunjett li fih 5 ml trombina umana (800 – 1200 IU/ ml).
LIST OF EXCIPIENTS
LISTA TA 'EĊĊIPJENTI
Human Fibrinogen: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, water for injections.
Fibrinoġen uman: arġinina kloridrat, gliċina, klorur tas- sodju, ċitrat tas- sodju, klorur tal- kalċju, ilma għall - injezzjonijiet.
Human Thrombin: calcium chloride, human albumin, mannitol, sodium acetate, water for injections.
Trombina umana: klorur tal- kalċju, albumina umana, mannitol, sodju aċetat, ilma għall- injezzjonijiet.
For epilesional use.
Għall- użu epileżjonali.
Do not apply intravascularly
Tapplikax ġol- vini
EXPIRY DATE
DATA TA 'SKADENZA
Do not re-freeze once thawed.
Terġax tiffriża ladarba jkun inħall is- silġ.
Store in the outer carton at -18°C or colder, to protect from light.
Aħżen fil- kartuna ta 'barra f' temperatura ta' - 18°C jew inqas, biex tilqa 'mid- dawl.
After thawing, store unopened vials in the outer carton at 2-8°C for up to 30 days starting on:
Wara t- taħlil tas- silġ, aħżen kunjetti mhux miftuħin fil- kartuna ta 'barra f' 2- 8°C sa 30 jum li jibdew nhar:
Any unused product should be discarded in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l - liġijiet lokali.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Vial label
Tikketta tal- kunjett
Human fibrinogen:
Fibrinoġen uman:
Human clottable protein 50 – 90 mg/ ml
Komponent 1: proteina umana li tgħaqqad 50 – 90 mg/ ml
For epilesional use.
Għal użu epileżjonali.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI
To be used as two-components product with supplied device.
Għandu jintuża bħala prodott b' żewġ komponenti bl- apparat fornut
Human thrombin 800-1200 IU/ ml
Komponent 2: trombina umana 800- 1200 IU/ ml
19 PACKAGE LEAFLET:
19 FULJETT TA 'TAGĦRIF:
EVICEL solutions for sealant Human fibrinogen, human thrombin
EVICEL soluzzjonijiet ta 'siġillant Fibrinoġen uman, trombina umana
- If you have any further questions, ask your doctor.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex
tell you doctor or pharmacist.
imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What EVICEL is and what it is used for 2.
X' inhu EVICEL u għalxiex jintuża 2.
Before you are treated with EVICEL 3.
Qabel ma tuża EVICEL 3.
How to use EVICEL 4.
Kif għandek tuża EVICEL 4.
Possible side effects 5 How to store EVICEL 6.
Kif taħżen EVICEL 6.
WHAT EVICEL IS AND WHAT IT IS USED FOR
X' INHU EVICEL U GĦALXIEX JINTUŻA
EVICEL is a Human Fibrin Sealant which is supplied as a package containing two separate vials, each containing 1 ml, 2 ml or 5 ml of solution (Fibrinogen and Thrombin respectively) Human Fibrinogen and Human Thrombin.
EVICEL huwa Siġillant li fih il- Fibrina Umana li huwa fornut bħala pakkett li fih żewġ kunjetti separati, kull wieħed fih 1 ml, 2 ml jew 5 ml ta 'soluzzjoni (Fibrinoġen u Trombina rispettivament) Fibrinoġen uman u Trombina umana.
An application device and appropriate accessory tips are supplied separately.
Apparat ta 'applikazzjoni u truf ta' aċċessorji addattati huma fornuti separatament.
Fibrinogen is a concentrate of clottable protein and Thrombin is an enzyme that causes clottable protein to coalesce.
Fibrinoġen huwa konċentrat ta 'proteina li tgħaqqad u t- trombina hija enzima li tikkawża l- fużjoni tal - proteina li tgħaqqad.
Thus, when the two components are mixed together they clot instantly.
Għalhekk, meta ż- żewġ komponenti jitħalltu flimkien huma jagħqdu fil- pront.
EVICEL is applied during surgical operations, to reduce bleeding and oozing during and after the operation.
EVICEL huwa applikat waqt operazzjonijiet kirurġiċi, biex inaqqas il- fsada u tnixxija waqt u wara l - operazzjoni.
It is dripped or sprayed onto cut tissue where it forms a thin layer that seals the tissue and stops bleeding.
Huwa jitqattar jew jisprejja ruħu għal fuq tessut maqtugħ fejn jifforma saff irqiq li jissiġilla t - tessut u jwaqqaf il- fsada.
EVICEL can also be used in blood vessels surgery and in surgery taking place in the area between the bowels and the posterior abdominal wall.
EVICEL jista 'jintuża wkoll f' kirurġija tal- vażi tad- demm u kirurġija li sseħħ bejn l- imsaren u l- ħajt addominali posterjuri.
BEFORE YOU ARE TREATED WITH EVICEL
QABEL MA TUŻA EVICEL
Do not use EVICEL
Tużax EVICEL
 if you are hypersensitive (allergic) to products made from human blood or to any of the other ingredients of EVICEL.
Jekk inti sensittiv iżżejjed (allerġiku) għall- prodotti magħmulin mid- demm uman jew għal xi sustanzi  oħrajn ta 'EVICEL.
Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure and breathing difficulties.
Sinjali ta 'reazzjonijiet bħal dawn jinkludu ħorriqija, raxx, għafis tas- sider, tħarħir, waqa' fil- pressjoni u diffikultajiet fit- teħid tan- nifs.
If these symptoms occur, the administration has to be discontinued immediately.
Jekk iseħħu dawn is- sintomi, l- amministrazzjoni għandha titwaqqaf minnufih.
Take special care with EVICEL
Oqgħod attent ħafna b' EVICEL
 When EVICEL is applied during surgery, the surgeon must ensure that it is only applied onto the surface of tissue.
Meta EVICEL huwa applikat waqt il- kirurġija, il- kirurgu għandu jassigura li jiġi applikat biss għal fuq  il- wiċċ tat- tessut.
EVICEL must not be injected into tissue or blood vessels because it would cause clots which could be fatal.  The use of EVICEL has not been studied in the following procedures, and there is therefore no information to show that it would be effective:
EVICEL m' għandux jiġi injettat għal ġot- tessut jew vażi tad- demm peress li huwa jikkaġuna tagħqid tad- demm li jista 'jkun fatali.
controlling bleeding in the stomach or intestines by applying the product through an endoscope (tube)
L- użu ta 'EVICEL ma ġiex studjat fil- proċeduri li ġejjin u għalhekk m' hemmx informazzjoni li turi li  tkun effikaċi: biex tinkolla t- tessuti flimkien; 
 Nearby areas should be protected to make sure that EVICEL is only applied onto the surface which is to be treated.  As with any product containing proteins, allergic type hypersensitivity reactions are possible.
20 kirurġija fil- moħħ jew fis- sinsla tad- dahar;  fil- kontroll ta 'l- emorraġija fl- istonku jew fl- imsaren bl- applikazzjoni tal - prodott permezz ta'  endoskopju (tubu); siġillar ta 'applikazzjonijiet kirurġiċi għall- imsaren.  Iż- żoni tal- madwar għandhom ikunu protetti biex jiġi żgurat li EVICEL ikun applikat esklussivament  fuq il- superfiċje li għandu jiġi ttrattat. Bħal kwalunwe prodott li fih il- proteini, jista' jkun hemm reazzjonijiet minn ipersensittività tat- tip allerġiku.
Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure and anaphylaxis.
Is- sinjali ta 'dawn ir- reazzjonijeit jinkludu ħorriqijia, raxx, għafis tas- sider, tħarħir, tnaqqis fil- pressjoni tad- demm u anafilassi.
If these symptoms occur, the administration has to be discontinued immediately.
Jekk dawn is- sintomi jseħħu, il- mediċina ma għandhiex tkompli tingħata b' effett immedjat.
 When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients.
Meta mediċini jsiru minn demm jew plażma umana, jiġu implimentati ċerti miżuri fil- post biex  jimpedixxu milli infezzjonijiet jgħaddu għal ġol- pazjenti.
These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of viruses/infections.
Dawn jinkludu għażla bir- reqqa ta 'donaturi tad- demm u plażma biex ikun assigurat li dawk f' riskju li jġorru infezzjonijiet ikunu esklużi, u l- ittestjar ta' kull donazzjoni u pool ta 'plażma għal sinjali ta' infezzjonijiet/ virusijiet.
Manufacturers of these products also include steps in the processing of the blood and plasma that can inactivate or remove viruses.
Manifatturi ta 'dawn il - prodotti jinkludu wkoll passi fl- ipproċessar tad- demm u l- plażma li jistgħu jinattivaw jew ineħħu virusijiet.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Minkejja dawn il- miżuri, meta jingħataw mediċini ppreparati minn demm jew plażma umana, il- possibbilità li tingħadda infezzjoni ma tistax tkun eskluża għal kollox.
This also applies to any unknown or emerging viruses, or other types of infections.
Dan japplika wkoll għal virusijiet mhux magħrufin jew emerġenti u tipi ta 'infezzjonijiet oħrajn.
The measures taken in the manufacture of Fibrinogen and Thrombin are considered effective for lipid coated viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus and the non- enveloped virus, hepatitis A.
Il- miżuri meħudin fil- manifattura ta 'Fibrinoġen u Trombina huma kkunsidrati effettivi għal virusijiet miksijin bil- lipidu bħalma huma l- virus mill- immunodefiċjenza umana (HIV), il- virus ta' l- epatite B u l- virus ta 'l- epatite Ċ u l- virus mhux enveloppat, epatite A.
The measures taken may be of limited value against parvovirus B19.
Il- miżuri meħudin jistgħu jkunu ta 'valur limitat kontra parvovirus B19.
Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).
Infezzjoni b' parvovirus B19 tista 'tkun serja għal nisa tqal (infezzjoni fetali) u għal individwi li s- sistema immunitarja tagħhom hija batuta jew li għandhom xi tipi ta' anemija (ngħidu aħna marda ta 'ċelloli minġel (sickle cell disease) jew anemija emolitika).
The healthcare professionals will record the name and batch number of the medicinal product in order to trace any possible infection source.
Il- professjonisti tal- kura tas- saħħa jirreġistraw l- isem u n- numru tal- lott tal- prodott mediċinali sabiex jittraċċaw kull sors ta 'infezzjoni possibbli.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
There is not enough information available to know whether any particular risks are associated with the use of EVICEL during pregnancy or whilst breast-feeding.
M' hemmx biżżejjed tagħrif disponibbli biex tkun taf jekk xi riskji partikolari humiex assoċjati ma 'l- użu ta' EVICEL waqt it- tqala jew waqt li tkun qegħda tredda '.
However, since EVICEL is used during a surgical operation, if you are pregnant or breast-feeding you should discuss the overall risks of the operation with your doctor.
Madankollu, peress li EVICEL jintuża waqt operazzjoni kirurġika, jekk inti tqila jew qegħda tredda 'għandek tiddiskuti r- riskji totali ta' l- operazzjoni mat- tabib tiegħek.
Pediatric use Data are too limited to support the safety and effectiveness of EVICEL in children.
Użu pedjatriku Id- dejta hija limitata wisq biex tappoġġja s- sigurtà u l- effettività ta 'EVICEL fit- tfal.
HOW TO USE EVICEL
KIF GĦANDEK TUŻA EVICEL
The doctor treating you will administer EVICEL during surgery.
It- tabib li qiegħed jagħtik it- trattament għandu jagħtik EVICEL matul l- intervent kirurġiku.
During your operation, your doctor will drip or spray EVICEL onto raw tissue during operations, using an application device.
Waqt l- operazzjoni tiegħek, it- tabib tiegħek sejjer iqattar jew jisprejja EVICEL fuq tessut miftuħ waqt l - operazzjonijiet, bl- użu ta 'apparat ta' applikazzjoni.
This device allows equal amounts of the two components of EVICEL to be administered at the same time, and ensures that they mix evenly, which is important for the sealant to have its optimal effect.
Dan l- apparat iħalli li ammonti ndaqs taż- żewġ komponenti ta 'EVICEL jingħataw fl- istess waqt, u jassigura li jitħalltu b' mod kullimkien l- istess, li huwa importanti għas- siġillant biex ikollu l- effett ottimali tiegħu.
The amount of EVICEL that will be applied depends on the surface area of tissue to be treated during the operation.
Il- kwantità ta 'EVICEL li għandha tiġi applicata tiddependi mis- superfiċje tat- tessut li għandu jiġi ttrattat matul l- operazzjoni.
It will be dripped onto the tissue in short bursts or sprayed in very small amounts (0.1-0.2 ml), to produce a thin, even layer.
Tintefa 'f' forma ta' qtar fuq it- tessut jew tiġi sprejjata fi kwantitajiet żgħar (0. 1- 0. 2 ml) bil- għan li jiġi prodott saff irqir u uniformi.
If application of a single layer of EVICEL does not completely stop the bleeding, a second layer may be applied.
Jekk l- applikazzjoni ta 'saff irqiq ta' EVICEL ma jwaqqafx kompletament l- emorraġija, jista 'jiġi applikat saff ieħor.
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI POTENZJALI
Like all medicines, EVICEL can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, EVICEL jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
EVICEL is a fibrin sealant.
EVICEL huwa siġillant li fih il- fibrina.
Fibrin sealants in general may, in rare cases (1 to 10 patients in 10,000), cause an allergic reaction.
Siġillanti li fihom il- fibrina in ġenerali jistgħu, f' każjiet rari (1 sa 10 pazjenti minn kull 10, 000), jikkaġunaw reazzjoni allerġika.
If you experience an allergic reaction you might have one or more of the following symptoms: skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, increased heart rate, tingling, vomiting or wheezing.
Jekk tesperjenza reazzjoni allerġika jista 'jkollok wieħed jew iktar mis- sintomi li ġejjin: raxx fil- ġilda, ħorriqija jew urtikarja, għafis fis- sider, tertir, fwawar, uġigħ ta' ras, pressjoni tad- demm baxxa, letarġija, nawżea, nuqqas ta 'sabar, żieda fir- rata tal- qalb, tnemmil, remettar jew tħarħir.
No allergic reactions have so far been reported in patients treated with EVICEL.
L- ebda reazzjoni allerġika ma ġiet irrapportata s' issa f' pazjenti ttrattati b' EVICEL.
There is also a theoretical possibility that you could develop antibodies to the proteins in EVICEL, which could potentially interfere with blood clotting.
Hemm ukoll possibbilità teorika li int tista 'tiżviluppa antikorpi għall- proteini f' EVICEL, li jistgħu potenzjalment jinterferixxu ma' l- għaqid tad- demm.
If you feel unwell tell your doctor immediately, even if your symptoms are different from those just described.
Jekk tħossok ma tiflaħx għid lit- tabib tiegħek minnufih, anke jekk is- sintomi tiegħek huma differenti minn dawk li għadhom kif ġew deskritti.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f' dan il- fuljett, jekk jogħġbok informa lit- tabib jew lill- ispiżjar tiegħek.
In clinical studies with EVICEL some undesired events occurred for which a causal relation to the application of EVICEL could not be excluded.
Fl- istudji kliniċi b' EVICEL seħħew xi episodji mhux mixtieqa li għalihom ma kienx possibbli li tiġi eskluża relazzjoni kawżali bl- applikazzjoni ta 'EVICEL.
After abdominal surgery some patients presented with an abscess, and in vascular surgery some cases of an occluded graft occurred which had do be re-operated.
Wara l- kirurġija addominali xi pazjenti ppreżentaw axxess u fil- kirurġija vaskulari seħħew xi każijiet ta 'okklużjoni tat- trapjant (graft) li ħtieġu intervent ieħor.
HOW TO STORE EVICEL
KIF TAĦŻEN EVICEL
Store in a freezer at -18°C or colder.
Aħżen fil- friżer f' temperatura ta '- 18°C jew inqas.
Do not use EVICEL after the expiry date which is stated on the label as well as the carton after EXP.
Tużax EVICEL wara d- data ta 'l- iskadenza li hija ddikjarata fuq it- tikketta kif ukoll fuq il- pakkett wara JIS.
The expiry date refers to the last day of that month.
Id- data ta 'l- iskadenza tirreferi għall- aħħar jum ta' dak ix- xahar.
Keep the vials in the outer carton in order to protect from light.
Żomm il- kunjetti fil- kartuna ta 'barra biex tilqa' mid- dawl.
After thawing, unopened vials can be stored at 2-8°C and protected from light, for up to 30 days.
Wara t- taħlil tas- silġ, kunjetti mhux miftuħin jistgħu jinħażnu f' temperatura ta '2- 8°C u milqugħin mid- dawl, sa 30 jum.
The Fibrinogen and Thrombin components are stable at room temperature for up to 24 hours but once drawn up into the application device, they must be used immediately.
Il- komponenti Fibrinoġen u Trombina huma stabbli f' temperatura ambjentali sa 24 siegħa, iżda la darba miġbudin ġewwa l- apparat ta 'l- applikazzjoni, jeħtieġ li jintużaw minnufih.
What EVICEL contains
X' fih EVICEL
Human clottable protein (50 - 90 mg/ml) Component 2:
Proteina umana li tagħqad (50 - 90 mg/ ml) Komponent 2:
Human thrombin (800 - 1,200 IU/ml)
Trombina umana (800 - 1, 200 IU/ ml)
Other ingredients are:
Sustanzi oħrajn huma:
Component 1: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride and water for injections.
Komponent 1: arġinina kloridrat, gliċina, klorur tas- sodju, ċitrat tas- sodju, klorur tal- kalċju u ilma għall - injezzjonijiet.
Component 2: calcium chloride, human albumin, mannitol, sodium acetate and water for injections.
Komponent 2: klorur tal- kalċju, albumina umana, mannitol, sodju aċetat u ilma għall- injezzjonijiet.
Pack sizes:
Daqsijiet ta 'pakketti:
EVICEL is available in the following sizes:
EVICEL huwa disponibbli fid- daqsijiet li ġejjin:
2 x 1 ml, 2 x 2 ml and 2 x 5 ml.
2 x 1 ml, 2 x 2 ml u 2 x 5 ml.
22 What EVICEL looks like and contents of the pack
22 Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
EVICEL is a Human Fibrin Sealant which is supplied as a package containing two separate vials, each containing 1 ml, 2 ml or 5 ml solution of Human Fibrinogen and Human Thrombin, respectively.
EVICEL huwa Siġillant li fih il- Fibrina Umana li hija fornuta bħala pakkett li fih żewġ kunjetti separati, kull wieħed fih 1 ml, 2 ml jew 5 ml soluzzjoni ta 'Fibrinoġen u Trombina rispettivament.
An application device and appropriate accessory tips are supplied separately.
L- apparat ta 'applikazzjoni u t- truf ta' aċċessorji addatati huma fornuti separatament.