qanastek/EMEA-V3 huggingface dataset:
* produced by recombinant DNA technology in yeast cells. ** corresponding to approximately 270,000 antithrombin units (ATU) or 18,000 ATU per mg of desirudin with reference to the WHO Second International Standard for alpha-thrombin.
* magħmul b’ teknoloġija rikombinanti ta ’ DNA fiċ- ċelluli tal- ħmira. ** korrispondenti għal madwar 270, 000 unità antitrombina (ATU) jew 18, 000 (ATU) kull mg ta ’ desirudin, b’ riferenza għat- Tieni Kejl Internazzjonali Standardizzat skond il- WHO għall- alpha - thrombin.
White powder and clear, colourless solvent for solution for injection
Trab abjad u solvent ċar, mingħajr kulur għal soluzzjoni għall- injezzjoni
Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement surgery.
Il- prevenzjoni ta ’ trombożi fil- vini fondi f’ pazjenti li ser issirilhom operazzjoni kirurġika ippjanata biex jinbidel il- ġok naturali tal- koxxa jew ta ’ l- irkobba b’ wieħed artifiċjali.
Treatment with Revasc should be initiated under the guidance of a physician with experience in coagulation disorders.
Il- kura b’ Revasc trid tinbeda taħt is- sorveljanza ta ’ tabib li għandu esperjenza fid- disturbi tal - koagulazzjoni.
Instructions for the preparation of Revasc are provided in section 6.6.
Struzzjonijiet għall- preparazzjoni ta ’ Revasc huma pprovduti f’ sezzjoni 6. 6.
Adult and elderly patients
Adulti u pazjenti anzjani
The recommended dose is 15 mg twice daily.
Id- doża irrakkomandata hija ta ’ 15 mg darbtejn kuljum.
The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used.
L- ewwel injezzjoni trid tinbeda minn 5 sa 15 - il minuta qabel l- operazzjoni kirurġika, iżda fil- każ li ser tintuża l- anasteżija reġjonali li tibblokka, trid tingħata wara.
Treatment with desirudin is then continued twice daily post-operatively for 9 days up to a maximum of 12 days or until the patient is fully ambulant, whichever occurs first.
Il- kura b’ desirudin titkompla wara l- operazzjoni, billi tingħata darbtejn kuljum għal 9 ijiem, sa massimu ta ’ 12- il jum, jew sakemm il- pazjent iqum fuq saqajh kompletament, liema jokkorri l- ewwel.
Currently, there is no clinical experience to support the use of desirudin beyond 12 days.
S’ issa, m’ hemmx esperjenza klinika biex tiġġustifika l- użu ta ’ desirudin ’ l fuq minn 12- il jum.
Administration is by subcutaneous injection, preferably at an abdominal site.
Jingħata permezz t’ injezzjoni subkutanja (taħt il- ġilda), preferibbilment f’ xi post fl- addome.
Injections should be rotated between at least four different sites.
L - injezzjonijiet iridu jsiru b’ sistema ta ’ rotazzjoni, f’ mhux anqas minn erba ’ siti differenti.
Patients with renal impairment
2 Pazjenti b’ indeboliment tal- kliewi
Desirudin is contraindicated in patients with severe renal impairment (creatinine clearance of less than 30ml/ min corresponding to a serum creatinine > 2.5mg/ dl or 221μ mol/ l; see section 4.3).
Desirudin huwa kontra- indikat f’ pazjenti li għandhom indeboliment serju tal- kliewi (tneħħija ta ’ creatinine t’ anqas minn 30 ml/ min, korrispondenti ma ’ livell ta ’ krejatinina fis- serum > 2. 5 mg/ dl jew 221 μmol/ l; ara sezzjoni 4. 3).
In patients with mild or moderate renal impairment (creatinine clearance between 31 and 90 ml/ min; see section 4.4) activated partial thromboplastin time (aPTT) should be monitored.
F’ pazjenti li għandhom indeboliment ħafif jew ta ’ grad moderat tal - kliewi, (tneħħija tal- krejatinina ta ’ bejn 31 u 90 ml/ min; ara sezzjoni 4. 4), il- ħin biex tkun attivata parzjalment it- tromboplastina (aPTT) irid ikun immoniterjat.
2 Patients with liver impairment
Pazjenti b’ indeboliment tal- fwied
Desirudin is contraindicated in severe hepatic impairment (see section 4.3).
Desirudin huwa kontra- indikat f’ indeboliment serju tal- fwied (ara sezzjoni 4. 3).
In patients with mild to moderate liver impairment (see section 4.4) aPTT monitoring is recommended.
F’ pazjenti b’ indeboliment ħafif jew ta ’ grad moderat tal- fwied (ara sezzjoni 4. 4) l- immonitorjar bl- aPTT huwa rakkomandat.
Desirudin is contraindicated in patients:
Desirudin huwa kontra- indikat f’ dawn il- pazjenti:
- with hypersensitivity to the active substance or to any of the excipients
- b’ sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi
- with active bleeding and/ or irreversible coagulation disorders
- b’ emorraġija attiva u/ jew taqlib irriversibbli tal- koagulazzjoni
- with severe renal and hepatic impairment
- b’ indeboliment serju tal- kliewi u l- fwied
- during pregnancy (see section 4.6)
- waqt it- tqala (ara sezzjoni 4. 6)
- with severe uncontrolled hypertension and subacute bacterial endocarditis.
- bi pressjoni għolja ħafna u mhux ikkontrollata, u b’ endokardite batterjali subakuta.
Warnings
Twissijiet
Revasc may cause allergic reactions including anaphylaxis and shock (see section 4.8).
Revasc jista ’ jikkawża reazzjonijiet allerġiċi, inklużi l- anafilassi u xokk (ara sezzjoni 4. 8).
Fatal anaphylactic reactions have been reported in patients re-exposed to hirudin product therapy in a second or subsequent treatment course.
Reazzjonijiet anafilattiċi fatali ġraw f’ pazjenti li kienu ri- esposti għal terapija bi prodott derivat mill hirudin fit- tieni kors ta ’ kura, jew korsijiet oħrajn sussegwenti.
Although fatal reactions have not been reported with desirudin, alternative treatment options must be considered before the decision to re-expose a patient to Revasc.
Għalkemm reazzjonijiet fatali ma kinux irrappurtati b’ desirudin, għażliet alternattivi ta ’ trattament iridu jkunu ikkonsidrati qabel ma tittieħed id- deċiżjoni li pazjent ikun ri- espost għal Revasc.
As these reactions are immune-mediated, patients with previous exposure to hirudin or hirudin analogue may be at an increased risk.
Peress li dawn ir- reazzjonijiet huma ikkaġunati minn mekkaniżmi immunoloġiċi, pazjenti li diġà ħadu hirudin, jew analogu tiegħu, għandhom riskju miżjud.
Treatment initiation with Revasc should be undertaken only in a setting where medical assistance is readily available and where there is access to treatment for anaphylactic reactions.
It- trattament b’ Revasc għandu jinbeda biss f’ ambjent fejn l- assistenza medika hija disponibbli sew u fejn hemm aċċess għat- trattament ta ’ reazzjonijiet anafilattiċi.
Patients should be informed that they have received Revasc.
Il - pazjenti għandhom ikunu nformati li ngħataw Revasc.
Desirudin should not be administered by intramuscular injection owing to the risk of local haematoma.
Desirudin m’ għandux jingħata permezz t’ injezzjoni fil- muskoli mħabba r- riskju li tifforma ematoma lokali.
Desirudin should be used with caution in conditions with increased risks of haemorrhage such as major surgery, biopsy or puncture of a non-compressible vessel within the last month; a history of haemorrhagic stroke, intracranial or intraocular bleeding including diabetic (haemorrhagic) retinopathy; a cerebral ischaemic attack within the last 6 months, a known haemostatic disorder (congenital or acquired, e. g. haemophilia, liver disease) or a history of gastrointestinal or pulmonary bleeding within the past 3 months.
Desirudin għandu jintuża b’ kawtela f’ sitwazzjonijiet fejn hemm riskji miżjudin t’ emorraġija bħall - operazzjonijiet kirurġiċi maġġuri, biopsy, jew titqiba f’ pajp tad- demm li ma jistax ikun ikkompressat, fl- aħħar xahar; storja ta ’ puplesija emorraġġika; ħruġ ta ’ demm fil- kranju jew fl- għajnejn, inkluż ir - retinopatija (emorraġika) fid- dijabete; attakk iskemiku ċerebrali fl- aħħar 6 xhur; marda emostatika magħrufa (mit- twelid jew akkwiżita, per eżempju l- emofilja, mard tal- fwied); jew storja t’ emorraġija gastro- intestinali jew pulmonari fl- aħħar tliet xhur.
Precautions
Prekawzjonijiet
When desirudin is administered in patients with increased risk of bleeding complications, mild to moderate hepatic dysfunction and/ or mild to moderate renal impairment, aPTT should be monitored and peak aPTT should not exceed twice the control value.
Meta jingħata desirudin lill- pazjenti li għandhom riskju miżjud ta ’ kumplikazzjonijiet li jwasslu għall - ħruġ tad- demm, dawk li għandhom disfunzjoni ħafifa jew moderata tal- fwied, u/ jew indeboliment ħafif jew moderat tal- kliewi, aPTT irid ikun immoniterjat, u l- ogħla estimu ta ’ aPTT m’ għandux ikun aktar minn darbtejn il- valur tal- kontroll.
If necessary, therapy with desirudin should be interrupted until aPTT returns to less than twice the control value at which time treatment with desirudin can be resumed at a reduced dose.
F’ dan il- punt it- trattament b’ desirudin jista ’ jerġa ’ jinbeda b’ doża anqas.
Desirudin should be used with care in patients receiving anticoagulants, and/ or platelet inhibitors, and/ or non-steroidal anti-inflammatory medicinal products.
3 Desirudin għandu jintuża b’ kawtela f’ pazjenti li qegħdin jingħataw sustanza kontra l- koagulazzjoni tad- demm, u/ jew inibituri tal- plejtlets, u/ jew mediċini mhux sterojdi kontra l- infjammazzjoni.
Monitoring for evidence of bleeding is advised (see section 4.5).
L - immonitjar għall- ħruġ tad- demm huwa irrakkomandat (ara sezzjoni 4. 5).
The concomitant use of desirudin with thrombolytics and ticlopidine has not been investigated in this patient population.
L- użu flimkien ta ’ desirudin ma ’ trombolitiċi u ticlopidine ma kienx studjat f’ dawn it- tipi ta ’ pazjenti.
The anticoagulant effect of desirudin is poorly reversible. aPTT levels can, however, be reduced by intravenous administration of DDAVP (desmopressin).
Madankollu, il- livelli ta ’ aPTT jistgħu jitnaqqsu bit- teħid ta ’ DDAVP (desmopressin) fil- vina.
Laboratory Tests:
Testijiet tal- laboratorju:
Activated partial thromboplastin time (aPTT) should be monitored in patients with increased risk of bleeding and/ or renal or hepatic impairment.
Il- ħin biex ikun attivat parzjalment tromboplastin (aPTT) għandu jkun immoniterjat f’ pazjenti li għandhom riskju miżjud għall- ħruġ tad- demm, u/ jew indeboliment tal- kliewi u tal- fwied.
Peak aPTT should not exceed twice the control value.
L- ogħla valur ta ’ aPTT m’ għandux ikun aktar minn darbtejn dak tal- valur tal- kontroll.
If necessary, therapy with desirudin should be interrupted until aPTT falls to less than
Jekk ikun hemm bżonn, it- terapija b’ desirudin trid titwaqqaf sakemm il- livell ta ’ aPTT jaqa ’ għal anqas minn darbtejn il- valur tal- kontroll, meta mbagħad, it- trattament b’ desirudin jista ’ jerġa ’ jinbeda b’ doża anqas (ara wkoll sezzjoni 4. 5).
3 twice the control at which time treatment with desirudin can be resumed at a reduced dose (see also section 4.5).
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effet farmacewtiku tal- prodott
Any agent which may enhance the risk of haemorrhage should be discontinued prior to initiation of desirudin therapy.
Kwalunkwe sustanza li tista ’ żżid ir- riskju t’ emorraġija għandha titwaqqaf qabel ma tinbeda t- terapija b’ desirudin.
If co-administration cannot be avoided, close clinical and laboratory monitoring should be conducted (see section 4.4).
Jekk dan ma jkunx possibli, għandu jsir kontroll mill- qrib, kemm kliniku kif ukoll permezz ta ’ testijiet tal- laboratorju (ara sezzjoni 4. 4).
During prophylaxis, concomitant use of medicinal products containing heparins (unfractionated and low-molecular weight heparins) and dextrans is not recommended.
Waqt il- profilassi, l- użu fl- istess ħin ma ’ prodotti medicinali li fihom il- heparins (kemm dawk mhux frazzjonati, kif ukoll dawk li għandhom piż baxx molekulari) u dextrans, mhux irrakkomandat.
The effects of desirudin and unfractionated heparins on prolongation of aPTT have been shown to be additive (see section 4.4).
L - effetti ta ’ desirudin u heparins mhux frazzjonati ntwerew li għandhom effett addizzjonali li jtawwal il - ħin ta ’ aPTT (ara sezzjoni 4. 4).
As with other anticoagulants desirudin should be used with caution in conjunction with medicinal products which affect platelet function these medicinal products include: acetylsalicylic acid and NSAIDs, ticlopidine and clopidogrel, glycoprotein IIb/ IIIa antagonists (abciximab, eptifibatide, tirofiban) and iloprost.
Bħalma jiġri b’ antikoagulanti oħra, desirudin għandu jintuża b’ kawtela flimkien ma ’ prodotti mediċinali oħra li jaffettwaw il- funzjoni tal- plejtlets, dawn il- prodotti mediċinali jinkludu: acetylsalicylic acid u NSAIDs, ticlopidine u clopidogrel, antagonisiti ta ’ glycoprotein IIb/ IIIa (abciximab, eptifibatide, tirofiban) u iloprost.
If a patient is switched from oral anticoagulants to desirudin therapy or from desirudin to oral anticoagulants, the anticoagulant activity should continue to be closely monitored with appropriate methods.
Jekk pazjent jinbidlulu l- antikoagulanti orali għal terapija b’ desirudin, jew minn desirudin għal antikoagulanti orali, l- attività kontra l- koagulazzjoni tad- demm trid tibqa ’ tkun immoniterjata mill- qrib b’ metodi xierqa.
That activity should be taken into account in the evaluation of the overall coagulation status of the patient during the switch (see section 4.2).
Dik l- attività trid titqies meta ssir l- evalwazzjoni ta ’ l- istatus sħiħ tal- koagulazzjoni fil- pazjent waqt il- bidla (ara sezzjoni 4. 2).
There are no adequate data from the use of desirudin in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ Revasc f’ nisa tqal.
Revasc is contraindicated in pregnancy (see section 4.3).
Revasc m’ għandux jingħata waqt it- tqala (ara sezzjoni 4. 3).
It is not known whether desirudin is excreted in human milk.
Mhux magħruf jekk desirudin jiġix eliminat fil- ħalib tas- sider tal- mara.
However, lactating mothers should be advised to avoid breast feeding or alternative medicinal products used.
Madankollu, ommijiet li qed ireddgħu għandhom ikunu mwissija biex jieqfu jagħmlu dan, jew jużaw prodotti mediċinali oħra.
4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex is- suq u tħaddem magni
Revasc has no or negligible influence on the ability to drive and use machines.
Revasc m’ għandu ebda effett jew, jekk għandu, ftit li xejn effett fuq il- ħila fis- sewqan u l- użu tal - magni.
In controlled clinical trials investigating desirudin 15 mg twice daily and a standard dose of unfractionated heparin, the nature of the hip surgery operation and the mode of action of the two drugs studied account for most of the adverse experiences reported.
F’ studji kliniċi ikkontrollati u investigattivi, desirudin, mogħti 15 mg darbtejn kuljum, mqabbel ma ’ doża standardizzata ta ’ heparin mhux frazzjonata, in natura tat- tip t’ operazzjoni kirurġika fuq il- ġog tal- koxxa u l- mod ta ’ kif jaħdmu ż- zewġ mediċini iddeterminaw il- maġġoranza ta ’ l- effetti avversi rapportati.
As with other anticoagulants, bleeding is the most common adverse reaction.
Bħalma jiġri b’ antikoagulanti oħra, il- ħruġ tad- demm hu l- aktar reazzjoni avversa komuni.
The following related adverse reactions were listed below by system organ class and within each frequency grouping, adverse reactions are presented in order of decreasing seriousness: common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000).
L- effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji: komuni (≥ 1/ 100 sa < 1/ 10); mhux komuni (≥ 1/ 1, 000 sa < 1/ 100); rari (≥ 1/ 10, 000 sa < 1/ 1, 000).
Investigations Uncommon:
Investigazzjonijiet Żieda fis- serum transaminases Mhux komuni:
4 Blood and the lymphatic system disorders Common:
Disturbi tad- demm u tas- sistema limfatika Anemija Komuni:
Nervous system disorders Uncommon:
Disturbi fis- sistema nervuża:
Dizziness, insomnia, confusion
Sturdament, nuqqas ta ’ rqad, konfużjoni Mhux komuni:
Respiratory, thoracic and mediastinal disorders Uncommon:
Disturbi respiratorji, toraċiċi u medjastinali Dispnea Mhux komuni:
Gastrointestinal disorders Common:
Disturbi gastro- intestinali Dardir Komuni:
Uncommon:
Ematemesi, rimettar, stitikezza Mhux komuni:
Renal and urinary disorders Uncommon:
Disturbi fil- kliewi u fis- sistema urinarja Ematurja, żamma ta ’ l- awrina Mhux komuni:
Skin and subcutaneous tissue disorders Uncommon:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Raxx, urtikarja Mhux komuni:
Metabolism and nutrition disorders Uncommon:
Disturbi fil- metaboliżmu u n- nutrizzjoni Ipokalemija Mhux komuni:
Infections and infestations Uncommon:
Infezzjonijiet u infestazzjonijiet Infezzjoni fl- apparat ta ’ l- awrina, ċistite Mhux komuni:
Uncommon:
Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura Tnixxija mill- ferita Komuni:
Uncommon:
Indeboliment fil- fejqan tal- ferita Mhux komuni:
Hypotension, deep thrombophlebitis Epistaxis, hypertension
Disturbi vaskulari Pressjoni tad- demm baxxa ħafna, tromboflebite profonda Komuni:
Uncommon:
Tinfaraġ, pressjoni tad- demm għolja Mhux komuni:
Fever, injection site mass, haematomas, oedema in legs Pain in legs, pain, abdominal and chest pain
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Deni, massa fis- sit ta ’ l- injezzjoni, ematomi, edema fir- riġlejn Komuni:
Immune system disorders Common:
Uġigħ fir- riġlejn, uġigħ, uġigħ fiż- żaqq u fis- sider Mhux komuni:
Allergic reactions have been reported in the same proportion (1.6%) of patients treated with desirudin (N=2,367) or with unfractionated heparin (N=1,1 34) in clinical trials, regardless of causality.
Disturbi fis- sistema immuni Reazzjonijiet allerġiċi kienu rrappurtati fl- istess proporzjon (1. 6%) tal- pazjenti Komuni: kkurati b’ desirudin (N=2, 367) jew b’ eparina mhux frazzjonati (N=1, 134) fi provi kliniċi, mingħajr ma jingħata kas tal- kawżalità.
Anti-hirudin antibodies have been detected upon re-exposure to desirudin in clinical trials.
Antikorpi anti- hirudin kienu osservati ma ’ l- espożizzjoni mill- ġdid għal desirudin Rari: fi provi kliniċi.
Adverse reactions irrespective of trial drug relationship reported during clinical trials were bleeding episodes, oliguria, hyperpyrexia and joint dislocation.
Ir- reazzjonijiet avversi, irrespettivament tar- relazzjoni ma ’ l- użu tas- sustanza li ngħatat bi prova, waqt l- istudji kliniċi, kienu ħruġ tad- demm, tnaqqis fil- volum ta ’ l’ awrina, deni għoli u ġogi żlugati.
In post-marketing surveillance, rare reports of major haemorrhages, some of which were fatal; and rare reports of non-fatal anaphylactic or anaphylactoid reactions leading to shock have been received.
5 Waqt is- sorveljanza li saret wara li l- prodott tħalla joħroġ fuq is- suq, kien hemm rapporti rari ta ’ emorraġiji serji, li xi ftit minnhom kienu fatali, u waslu rapporti rari ta ’ reazzjonijiet anafilattiċi jew anafilattojdi mhux fatali li wasslu għal xokk.
There is no antidote for desirudin.
Ma jeżistix antidot kontra desirudin.
Overdosage of desirudin could lead to bleeding complications.
Doża eċċessiva ta ’ desirudin, tista ’ twassal għall - kumplikazzjonijiet emorraġiċi.
If necessary, plasma expanders and/ or blood transfusion may be used.
F’ każ ta ’ bżonn, sostanzi li jintużaw flok il- plażma u/ jew trasfużżjoni tad- demm jistgħu jintużaw.
Anticoagulant, ATC code:
Antikoagulant, kodiċi ATC:
Mechanism of action
Il- mod kif jaħdem
Desirudin is a highly potent and selective inhibitor of free circulating and clot-bound thrombin.
Desirudin huwa inibitur selettiv u qawwi ħafna ta ’ thrombin liberu li qed jiċċirkola fid- demm, kif ukoll dak li hu marbut mad- demm magħqud.
A mean peak aPTT prolongation of around 1.4 times baseline value is observed following a subcutaneous (SC) b. i. d. injection of 15mg desirudin.
L- ogħla livell medju ta ’ aPTT imtawwal kien ta ’ madwar 1. 4 drabi tal- valur fil- bidu, wara injezzjoni subkutanja (SC) b. i. d. ta ’ 15 mg desirudin.
At therapeutic serum concentrations it has no effect on other enzymes of the haemostatic system such as factors IXa, Xa, kallikrein, plasmin, tPA, or activated protein C.
F ’ livelli terapewtiċi fis- serum, m’ għandux effett fuq l- enżimi l- oħra tas- sistema emostatika, bħas - sustanzi IXa, Xa, kallikrein, plasmin, tPA, jew il- proteina Ċ attivata.
In addition, it does not display any effect on other serine proteases, such as the digestive enzymes trypsin or chymotrypsin, or on complement activation by the classical or alternative pathways.
Barra minn hekk, ma jurix effetti fuq enżimi serine proteases, bħall- enżimi diġestivi trypsin jew chymotrypsin, jew fuq l- attivar tal - komplement, permezz tas- sistema klassika jew dik alternattiva.
In two controlled double blind clinical trials, the overall rate of thromboembolic events in patients treated with desirudin 15mg s. c. b. i. d.
F’ żewġ studji kliniċi double- blind ikkontrollati, ir- rata totali t’ episodji trombo- emboliċi f ’ pazjenti ttrattati b’ desirudin 15 mg SC b. i. d.
(N=370) was half that in patients treated with a standard dose of unfractionated heparin (N=396) (p < 0.0001); the rate of proximal deep venous thrombosis was only one fifth that observed with the heparin (p < 0.0001).
Ir- rata ta ’ trombożi tal- vini fondi u prossimi kienet biss ta ’ 1 minn 5 ta ’ dawk il- każijiet li ħadu heparin (p < 0. 0001).
To date clinical data are available on hip surgery only.
S’ issa, it- tagħrif kliniku huwwa disponibbli għall- operazzjonijiet kirurġiċi fuq il- ġog tal- koxxa biss.
The anticoagulant properties of desirudin are demonstrated by its ability to prolong the clotting time of human or rat plasma whether induced directly (thrombin time) or via the intrinsic (aPTT) or extrinsic (PT) pathways.
Il- kwalitajiet antikoagulanti ta ’ desirudin jintwerew fl- abbiltà li jtawwal il- ħin biex tagħqad il- plażma tal- bniedem jew tal- far, kemm jekk indott direttament (il- ħin ta ’ trombin) jew permezz ta ’ toroq intrinsiċi (aPTT) jew estrinsiċi (PT).
Desirudin has no profibrinolytic activity.
Desirudin m’ għandux attività profibrinolitika.
Mean absorption time of subcutaneous (SC) desirudin is 4.1, 4.5 and 5.4 h for dose levels of 0.1, 0.3 and 0.5 mg/ kg, respectively (overall mean = 4.6 h).
Il- medji tal- ħinijiet għall- assorbiment ta ’ desirudin mit- tessut subkutanju (SC) huma ta ’ 4. 1, 4. 5 u 5. 4 sigħat, korrispondenti għall- livelli ta ’ dożaġġi ta ’ 0. 1, 0. 3 u 0. 5 mg/ kg, rispettivament (medjan totali = 4. 6h).
Absorption is complete based on mean area under the curve (AUC) values.
L- assorbiment huwa komplut meta dan ikun ibbażat fuq il- valuri ta ’ l- erja medja taħt il- kurva (AUC).
Following administration of single SC doses of 0.1-0.75 mg/ kg, plasma concentrations of desirudin increased rapidly to maximum levels (Cmax) between 1 and 3 h.
Wara li jingħataw dożi singli SC ta ’ 0. 1- 0. 75 mg/ kg, il- konċentrazzjoni ta ’ desirudin fil- plażma jiżdiedu malajr biex jilħqu l- livell massimu (Cmax) f’ ħin ta ’ bejn siegħa u 3 sigħat.
Both Cmax and AUC values are dose proportional.
Kemm il- valuri ta ’ Cmax u AUC huma proporzjonali għad- doża.
Desirudin is distributed in the extracellular space with a distribution volume at steady state of 0.251/ kg independently of the dose.
Desirudin huwa distribwit fl- ispazju ta ’ barra ċ- ċelluli, b’ volum ta ’ distribuzzjoni fiss ta ’ 0. 25 l/ kg, indipendentement mid- doża.
Metabolism and elimination
6 Metaboliżmu u tneħħija
The disappearance of desirudin from plasma is rapid in the first phase with approximately 90% of an intravenous (IV) bolus dose disappearing from the circulation within 2 hours of the injection.
It- tneħħija mill- plażma ta ’ desirudin huwa mgħaġġel fl- ewwel fażi, b’ madwar 90% ta ’ doża bolus ġol - vina (IV) tisparixxi miċ- ċirkolazzjoni, fi żmien sagħtejn ta ’ l- injezzjoni.
A slower terminal elimination phase follows with a dose-independent mean terminal elimination half-life of 2 to 3 h.
Sussegwentement hemm fażi ta ’ half- life ta ’ l- eliminazzjoni terminali, b’ rata aktar baxxa, ta ’ bejn 2 sa 3 sigħat li hija indipendenti mid- doża wżata.
The mean residence times are 1.7-2 h and 6-7 h after IV and SC administration, respectively.
Iż- żmien medju ta ’ persistenza meta jingħata IV jew SC huwa ta ’ 1. 7 sa sagħtejn, jew minn 6 sa 7 sigħat, rispettivament.
The total urinary excretion of unchanged desirudin amounts to 40-50% of the administered dose.
It- tneħħija totali fl’ awrina ta ’ desirudin mhux mibdul jammonta għal 40 - 50% tad- doża mogħtija.
Metabolites lacking one or two C-terminal amino acids constitute a minor proportion of the material recovered from urine (< 7%).
Il - metaboliti, li għandhom wieħed jew żewġ amminoaċidi neqsin mis- C- terminal, jagħmlu proporzjon żgħir tal- materjal irkuprat mill- awrina (< 7%).
In vitro and in vivo animal data indicate that desirudin is for the most part eliminated and metabolised by the kidney.
Tagħrif in vitro u in vivo fl- annimali jindikaw li desirudin huwa fil- parti l- kbira eliminat u metabolizzat mill- kliewi.
Hepatic elimination of desirudin or the thrombin- desirudin complex does not appear to be significant.
L- eliminazzjoni epatika ta ’ desirudin jew dak magħrbut ma’ thrombin ma tidhirx sinifikanti.
6 Total clearance of desirudin has been found to be in the same range following either SC or IV administration (ca 1.95-2.20ml/ min/ kg) and was dose-independent.
It- tneħħija totali ta ’ desirudin mill- ġisem instabet li hija fl- istess firxa, kemm jekk ingħata SC jew IV (ca 1. 95- 2. 20 ml/ min/ kg), u kienet indipendenti mid- doża wżata.
The total and renal clearances of desirudin are slightly reduced in elderly subjects compared to young volunteers.
It- tneħħija totali u dik permezz tal - kliewi ta ’ desirudin huma ftit imnaqqsin f’ pazjenti anzjani meta mqabblin ma ’ voluntiera żgħar fl- età.
This decrease can be considered unlikely to be of clinical significance, thus requiring no dose reduction.
Dan it- tnaqqis jista ’ jitqies li huwa x’ aktarx insinifikanti minn aspett kliniku u, għalhekk, l- ebda tnaqqis fid- doża mhu meħtieġ.
Reproductive toxicology studies in animals showed desirudin to be teratogenic with changes comprising spina bifida in rabbits and omphaloceles in rats.
Studji tossikoloġiċi fuq ir- riproduzzjoni fl- annimali wrew li desirudin huwa teratoġeniku b’ effetti li jinkludu spina bifida fil- fniek u omphaloceles fil- firien.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Informazzjoni li mhix klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il - ġeni, riskju ta ’ kanċer, ma ’ turi l- ebda periklu speċjali għall- bnedmin.
magnesium chloride sodium hydroxide
Trab: magnesium chloride sodium hydroxide Solvent:
mannitol (E 421) water for injections
mannitol (E 421) ilma għall- injezzjoni
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma ’ jablux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C when reconstitution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, iż- żmien tal- ħażna waqt l- użu u l- kundizzjonijiet ta ’ qabel l- użu huma r - responsabbiltà ta ’ min qed jużah, u normalment ma jkunux itwal minn 24 siegħa f’ temperatura ta ’ 2 sa 8°C, meta r- rikostituzzjoni tkun saret f’ kundizzjonijiet asettiċi kkontrollati u vverifikati.
Keep the vial and ampoule in the outer carton in order to protect from light.
Żomm il- kunjett u l- ampulla fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
6.5 Nature and contents of container
7 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
15mg of powder in a vial (Type I glass) with stopper (butyl rubber) covered with a film (fluoropolymer) in the product side and 0.5ml of solvent in an ampoule (Type I glass).
15 mg ta ’ trab ġo kunjett (ħġieġ tat- Tip I) b’ tappini (tal- lasktu tat- tip butyl) miksija b’ lega (fluoropolymer) fuq in- naħa ta ’ ġewwa, fejn imiss mal- prodott u 0. 5 ml ta ’ solvent f’ ampulla (ħġieġ tat- Tip I).
Pack size of 1, 2 or 10.
Pakketti ta ’ 1, 2 jew 10.
To prepare the reconstituted aqueous solution, 0.5ml of the accompanying mannitol solvent is added under aseptic conditions to the vial containing the powder for solution for injection.
Biex tkun ippreparata s- soluzzjoni bl- ilma, 0. 5 ml tas- solvent ta ’ mannitol ipprovdut, għandu jiżdied taħt kundizzjonijiet asettiċi, fil- kunjett li fiha t- trab għas- soluzzjoni għall- injezzjoni.
The active substance is rapidly redispersed by shaking gently producing a clear solution.
Is- sustanza attiva terġa ’ tinfirex malajr billi iċċekċek il- kunjett bil- mod u tipproduċi soluzzjoni ċara.
The reconstituted solution should be used as soon as possible (see section 6.3 above).
Is- soluzzjoni lesta għandha tintuża malajr kemm jista ’ jkun (ara sezzjoni 6. 3 hawn fuq).
Any unused product or waste material should be disposed 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.
Do not use reconstituted vials containing visible particles.
Tużax kunjetti b’ soluzzjoni li għandhom frak viżibli.
Canyon Pharmaceuticals Limited 20-22 Bedford Row London WC1R 4JS United Kingdom
Canyon Pharmaceuticals Limited 20- 22 Bedford Row London WC1R 4JS Renju Unit
2 vials/ 2 ampoules of solvent 10 vials/ 10 ampoules of solvent 1 vial/ 1 ampoule of solvent
2 kunjetti / 2 ampulli ta ’ solvent 10 kunjetti / 10 ampulli ta ’ solvent 1 kunjett/ 1 ampulla tas- solvent
9 July 1997 Date of latest renewal:
9 ta ’ Lulju 1997 Data ta ’ l- aħħar tiġdid:
9 July 2007
9 ta ’ Lulju 2007
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U D- DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U D- DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
NOVARTIS Pharma AG Lichtstrasse 35 CH-4056 Basel Switzerland
NOVARTIS Pharma AG Lichtstrasse 35 CH- 4056 Basel Svizzera
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ FUQ ID- DETENTUR TA ’ L AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Summary of Product Characteristics, section 4.2).
Sommarju tal- Karatteristiċi tal - Prodott fil- Qosor, sezzjoni 4. 2).
OUTER CARTON:
FUQ IL- KAXXA TA ’ BARRA:
FOR 2 VIALS (15mg/ vial) AND 2 AMPOULES
GĦAL 2 KUNJETTI (15 mg / kunjett) U 2 AMPULLI
Revasc 15mg/ 0.5ml powder and solvent for solution for injection Desirudin
Revasc 15 mg / 0. 5 ml trab u solvent għas- soluzzjoni għall- injezzjoni Desirudin
Each vial contains 15mg desirudin with 18,000 ATU/ mg corresponding to approximately 270,000 ATU per vial.
Kull kunjett għandu 15 mg desirudin bi 18, 000 ATU/ mg, korrispondenti għal madwar 270, 000 ATU kull kunjett
Powder: magnesium chloride, sodium hydroxide Solvent: mannitol, water for injections
Trab: magnesium chloride, sodium hydroxide Solvent: mannitol, ilma għall- injezzjoni
Powder and solvent for solution for injection 15mg of powder in a vial and 0.5ml of solvent in an ampoule
Trab u solvent għas- soluzzjoni għall- injezzjoni 15 mg ta ’ trab ġo kunjett u 0. 5 ml ta ’ solvent f’ ampulla
Pack size of 2
Id- daqs tal- pakkett huwa ta ’ 2
Reconstitute immediately before use with solvent provided.
Ħallat immedjatament qabel l- użu bis- solvent ipprovdut.
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINHAŻEN
After reconstitution, immediate use is recommended.
Taħżinx f’ temperatura ’ l fuq minn 25oC Wara li tħallat, l- użu immedjat huwa irrakkomandat.
However, the in-use stability has been demonstrated for 24 hours between 2ºC and 8ºC (in a refrigerator).
Madankollu, l- istabbiltà waqt l- użu ntwera li hija ta ’ 24 siegħa meta jinżamm bejn 2oC u 8oC (fil- friġġ).
OUTER CARTON:
FUQ IL - KAXXA TA ’ BARRA:
FOR 10 VIALS (15mg/ vial) AND 10 AMPOULES
GĦAL 10 KUNJETTI (15 mg / kunjett) U 10 AMPULLI
Pack size of 10
Id- daqs tal- pakkett huwa ta ’ 10
Do not store above 25ºC.
Taħżinx f’ temperatura ’ l fuq minn 25oC.
After reconstitution, immediate use is recommended.
Wara li tħallat, l- użu immedjat huwa irrakkommandat.
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
INFORMAZZJONI BIL- BRAILLE
FOR 1 VIAL (15mg/ vial) AND 1 AMPOULE
GĦAL KUNJETT 1 (15 mg / kunjett) U 1 AMPULLA
Each vial contains 15mg desirudin with 18,000 ATU/ mg corresponding to approximately 270,000 ATU per vial.
Kull kunjett għandu 15 mg desirudin bi 18, 000 ATU/ mg, korrispondenti għal madwar 270, 000 ATU kull kunjett.
Pack size of 1
Id- daqs tal- pakkett huwa ta ’ 1
Revasc 15 mg/ 0.5 ml Powder for injection Desirudin Subcutaneous use
Revasc 15 mg / 0. 5 ml Trab għall- injezzjoni Desirudin Użu għal taħt il- ġilda
15mg of desirudin
15 mg desirudin.
AMPOULE LABEL:
TIKKETTA TA ’ L- AMPULLA:
0.5ml SOLVENT
0. 5 ml SOLVENT
Revasc 15 mg/ 0.5ml Solvent for parenteral use
Revasc 15 mg / 0. 5 ml Solvent għall- użu parenterali
0.5ml of water for injections with 3% (w/ v) of mannitol
0. 5 ml ta ’ ilma għal injezzjonijiet ma ’ 3% (w/ v) ta ’ mannitol
Revasc 15mg/ 0.5ml powder and solvent for solution for injection Desirudin
Revasc 15 mg/ 0. 5 ml trab u solvent għal soluzzjoni għall- injezzjoni Desirudin
- If you have any further questions, ask your doctor, nurse or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib, lin- ners jew lill- ispiżjar tiegħek.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex
please tell your doctor or nurse.
imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lin- ners tiegħek.
What Revasc is and what it is used for 2.
X’ inhu Revasc u għalxiex jintuża 2.
Before you use Revasc 3.
Qabel ma tieħu Revasc 3.
How to use Revasc 4.
Kif għandek tuża Revasc 4.
How to store Revasc 6.
Kif taħżen Revasc 6.
WHAT REVASC IS AND WHAT IT IS USED FOR
X’ INHU REVASC U GĦALXIEX JINTUŻA
The common name of the active substance in Revasc is desirudin.
L- isem komuni tas- sustanza attiva f’ Revasc hija desirudin.
Desirudin is a recombinant DNA product derived from yeast cells.
Desirudin huwa prodott derivat miċ- ċelluli tal- ħmira bl- użu tat- teknoloġioja rikombinanti ta ’ DNA.
Desirudin belongs to a group of medicines called anticoagulants, which prevent blood clots from forming in the blood vessels.
Desirudin jappartjeni għall- klassi ta ’ mediċini msejħa sustanzi kontra l- koagulazzjoni tad- demm, li ma jħallux id- demm jagħqad fil- pajpijiet tad- demm.
Revasc is used to prevent blood clotting after elective hip or knee replacement surgery, as harmful blood clots can form in the blood vessels of the legs.
Revasc jintuża biex ma jħallix id- demm jagħqad wara operazzjoni kirurġika u ppjanata biex jinbidel il - ġog tal- koxxa u ta ’ l- irkoppa, għax demm magħqud perikoluż jista ’ jifforma fil- pajpijiet tad- demm fir - riġlejn.
It is often given for several days after operations because blood clots are most likely to form when you are resting in bed.
Ta ’ sikwit jingħata għal diversi jiem wara l- operazzjonijiet għax huwa aktar probabbli li jifforma d- demm magħqud meta inti tkun qed tistriħ fis- sodda.
BEFORE YOU USE REVASC
QABEL MA TIEĦU REVASC
You must not be given Revasc
Tieħux Revasc
- if you are hypersensitive (allergic) to natural or synthetic hirudin, including desirudin or any of the
- jekk inti tbati minn sensittivita eċċessiva (allerġija) għal hirudin naturali jew sintetiku, inkluż
other ingredients of Revasc
desirudin jew wieħed mill- ingredjenti l- oħra ta ’ Revasc
- if you are bleeding a lot or have any serious bleeding disorder (e. g. haemophilia)
- jekk qed titlef ħafna demm jew qed tbati minn kundizzjoni serja ta ’ ħruġ tad- demm (e. g.
- if you have serious kidney or liver disease
- jekk għandek mard serju tal- kliewi jew tal- fwied
- if you have a heart infection
- jkek għandek infezzjoni tal- qalb
- if you have an uncontrolled high blood pressure
- jekk għandek pressjoni għolja mhux ikkontrollata
- if you are pregnant.
- jekk inti tqila
Take special care with Revasc Make sure you tell your doctor if you are likely to have an increased risk of bleeding, which may be the case if you have, or have had:
Oqgħod attent ħafna b’ Revasc Kun żgur li tgħid lit- tabib tiegħek jekk aktarx għandek riskju akbar ta ’ ħruġ tad- demm, li jista ’ jiġri jekk għandek jew kellek:
- bleeding disorders or a family history of bleeding disorder
- mard ta ’ ħruġ tad- demm jew storja fil- famlija ta ’ mard ta ’ ħruġ tad- demm
- stomach ulcers or any other bleeding disease of the gut
- ulċeri fl- istonku jew kwalunkwe mard ta ’ ħruġ tad- demm fl- intestin
- history of a stroke, or bleeding within the brain or eye
- puplesija, jew ħruġ tad- demm fil- moħħ jew fl- għajnejn
- a recent operation (including dental surgery) or biopsy or pricking of a blood vessel within the last
- operazzjoni reċenti (inkluża l- kirurġija dentali), jew biopsy, jew taqqabt xi pajp tad- demm f’ dan
month
l- ahhar xahar
- recently a brief shortage of blood supply to a part of the brain within the last six months
- perijodu qasir ta ’ nuqqas fil- provvista tad- demm għal xi parti tal- moħħ f’ dawn l- aħħar 6 xhur
- bleeding in the gut or lung within the past three months.
- ħruġ tad- demm minn imsarnek jew fil- pulmun f’ dawn l- aħħar 3 xhur
Your risk of bleeding may also be increased:
Ir- riskju ta ’ ħruġ tad- demm jista ’ jiżdied ukoll:
- if you have recently given birth, fallen, or suffered a blow to the body or head
- jekk għadek kif wellidt, waqajt, jew qlajt xi daqqa fuq ġismek, jew fuq ir- ras
- if you are already taking medicines, especially blood-thinners (see below).
- jekk diġa qed tieħu xi mediċini, speċjalment dawk li jraqqu d- demm (ara hawn taħt)
22 If any of the above apply to you, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly.
Jekk xi kundizzjoni msemmija hawn fuq tapplika għalik, it- tabib jew l- infermier jimmoniterjalek id - demm tiegħek għat- tagħqid, u għandu mnejn ibidillek id- doża jew it- tqassim tad- dożi, kif jixraq.
Cross-sensitivity to other hirudin products is possible.
L- allerġija għal prodotti oħra ta’ hirudin huwa possibli.
You should also inform your doctor if you have ever received Revasc, hirudin or an hirudin analogue.
Għandek ukoll tinforma lit- tabib tiegħek jekk qatt irċevejt Revasc, hirudin jew derivattiv ta’ hirudin.
Children There is no experience with Revasc in children.
Tfal M’ hemx esperjenza bl- użu ta ’ Revasc fit- tfal.
It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines.
Jista ’ jkun hemm bżonn li tinbidel id- doża, jew tieħu xi prekawzjonijiet oħra, jew f’ xi każijiet tieqaf tieħu waħda mill- mediċini.
This applies to both prescription and non-prescription medicines, especially:
Dan japplika għal dawk il- mediċini li jinxtraw b’ riċetta jew mingħajrha, speċjalment:
- medicines used to prevent blood-clotting (warfarin, heparin and dicoumarol)
- il- mediċini li jintużaw biex iwaqqfu d- demm milli jagħqad (warfarin, heparin u dicoumarol)
- medicines which affect the function of platelets (particles in the blood involved in blood-
- il- mediċini li jaffettwaw il- funzjoni tal- plejtlets (partiċelli fid- demm involuti fit- taqgħid tad -
clotting), e. g. acetylsalicylic acid, a substance present in many medicinal products used to relieve pain and lower fever, and other non-steroidal anti-inflammatory agents.
demm), e. g. acetylsalicylic acid, sustanza li tinsab f’ ħafna prodotti mediċinali wżati biex itaffu l - uġigħ u jniżżlu d- deni, u sustanzi oħra mhux sterojdi użati kontra l- infjammazzjoni.
Pregnancy and breast-feeding You should not be given Revasc if you are pregnant.
Tqala u treddigħ M’ għandekx tingħata Revasc jekk inti tqila.
Revasc can cause serious harm to your baby.
Revasc jista ’ jikkawża ħsara serja lit- tarbija tiegħek.
It is therefore important to tell your doctor if you are pregnant or planning to become pregnant.
Għalhekk hu importanti li tgħid lit- tabib tiegħek jekk inti tqila jew jekk qed tippjana li toħroġ tqila.
If you are of a child-bearing age, a pregnancy test may be done by your doctor to make sure you are not pregnant.
Jekk inti mara f’ età li jista ’ jkollok it- tfal, jista ’ jsir test tat- tqala mit- tabib tiegħek biex tiżgura li m’ intix tqila.
It is advisable not to breast-feed during treatment.
Hu rakkomandat li ma treddax matul il- kura.
HOW TO USE REVASC
KIF GĦANDEK TUŻA REVASC
You will be given Revasc as an injection under the skin.
Sejjer tingħata Revasc bħala injezzjoni taħt il- ġilda.
Administration is by subcutaneous injection, preferably at an abdominal site.
Tittieħed b’ injezzjoni subkutanja, preferibbilment f’ post addominali.
Injections should be rotated between at least four different sites.
L- injezzjonijiet għandhom jingħataw f’ mhux anqas minn erba ’ postijiet differenti, b’ sistema ta ’ rotazzjoni.
The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used.
L- ewwel injezzjoni trid tinbeda minn 5 sa 15- il minuta qabel l- operazzjoni, iżda wara l- anasteżija reġjonali li tinblokka n - nervaturi, jekk ser tintuża.
Treatment with desirudin is then continued twice daily post-operatively for 9 to a maximum of 12 days or until the patient is fully mobile, whichever occurs first.
It- trattament b’ desirudin imbagħad irid jitkompla darbtejn kuljum wara l - operazzjoni sa 9, għall- massimu ta ’ 12- il jum, jew sakemm il- pazjent ikun kompletament mobbli, liema jiġri l- ewwel.
Currently, there is no clinical experience to support the use of Revasc beyond 12 days.
Bħalissa, m’ hemx esperjenza klinika li tiffavorixxi l- użu ta ’ Revasc għal aktar minn 12- il jum.
Usual dosage
Dożaġġ tas- soltu
Always take Revasc exactly as your doctor has instructed you.
Dejjem għandek tieħu Revasc eżattament kif jgħidlek it- tabib tiegħek.
You should check with your doctor or pharmacist if you are unsure.
Għandek tistaqsi lit- tabib jew l - ispiżjar tiegħek jekk m’ intix ċert.
The usual dosage is 15mg injected twice a day for 9 days to a maximum of 12 days.
Id- doża tas- soltu hija ta ’ 15 mg injettata darbtejn kuljum għal 9 ijiem sa massimu ta ’ 12- il jum.
You will be given the first injection within 5 to 15 minutes before the operation.
Sejjer tingħata l- ewwel injezzjoni minn 5 sa 15- il minuta qabel l - operazzjoni.
If you need treatment for longer than 12 days, the doctor may switch you to another similar medicine.
Jekk teħtieġ trattament aktar fit- tul minn 12- il jum, it- tabib jista ’ jaqliblek fuq mediċina oħra.
If you have a kidney or liver disease, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly.
Jekk għandek mard tal- kliewi jew tal- fwied, it- tabib jew l- infermier jimmoniterjalek l- istat tat- tagħqid tad- demm, u jista ’ jibdillek id- doża jew l- iskeda ta ’ dożaġġ skond il- bżonn.
If you are given more than you should
23 Jekk tieħu aktar Revasc milli suppost:
Overdose with Revasc may lead to bleeding.
Doża eċċessiva ta ’ Revasc tista ’ twassal għall- ħruġ ta ’ demm.
If this occurs, Revasc will be stopped and treatment given for the bleeding.
Jekk dan sseħħ, Revasc ser jitwaqqaf u tingħata l- kura għall- ħruġ ta ’ demm.
If a dose is missed
Jekk tinsa tieħu Revasc
23 If a dose of this medicine is missed, it should be given to you as soon as possible.
Jekk tħalli barra doża waħda ta ’ din il- mediċina, għandha tingħatalek mill- aktar fis.
If it is almost time for the next dose you will skip the missed dose and go back to the normal dosage schedule.
Jekk ikun kważi wasal il- ħin għad- doża li tmiss għandek taqbeż id- doża li tlift, u tmur lura għall- iskeda normali ta ’ dożaġġ.
The dose should not be doubled.
Id- doża m’ għandiex tkun irduppjata.
Like all medicines, Revasc can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Revasc jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Some of these side effects may be similar to the effects of surgery.
Xi wħud minn dawn l- effetti jistgħu jkunu bħall- dawk ta ’ l- operazzjoni.
The most likely side effect is bleeding.
L- aktar effett komuni huwa l- ħruġ tad- demm.
Tell the doctor or nurse as soon as possible if any of the following side effects occur, some of which may be confused with side effects of surgery:
Għid lit- tabib jew l- infermier mill- aktar fis jekk jkollok kwalunkwe wieħed minn dawn l- effetti jokkorru, filwaqt li xi wħud minnhom jistgħu jkunu mifxula ma ’ l- effetti ta ’ l- operazzjoni.
Common reported side effects (likely to affect between 1 in 10 and 1 in 100 patients):
Effetti sekondarji komuni rappurtati (li x’ aktarx li ser jaffettwaw bejn 1 minn kull 10 u 1 minn kull 100 pazjent):
Unusual tiredness or weakness (anaemia), nausea, oozing of fluid from wounds, low blood pressure, fever, inflammation of veins sometimes accompanied by a clot, lumps at injection sites, bruising, swelling of the legs caused by fluid retention, non-fatal allergic reactions.
Għeja jew dgħjufija mhux tas- soltu (anemija), nawseja, tnixxija ta ’ fluwidu mill- feriti, pressjoni tad - demm baxxa, deni, infjammazzjoni tal- vini li xi kultant tkun akkompanjata minn embolu, nefħa fis- sit ta ’ l- injezzjoni, tbenġil, nefħa tal- riġlejn ikkawżata miż- żamma tal- fluwidu, reazzjonijiet allerġiċi mhux fatali.
Uncommon side effects (likely to affect between 1 in 100 and 1 in 1,000 patients):
Effetti sekondarji mhux komuni (li x’ aktarx li ser jaffettwaw bejn 1 minn kull 100 u 1 minn kull 1, 000 pazjent):
Increase in liver enzymes, dizziness, sleeplessness, confusion, feeling breathless, vomiting (with or without blood), constipation, blood in your urine, difficulty in urinating, rash, itching (urticaria), low levels of potassium in the blood, burning feeling when passing urine with also an increased frequency of urination, slow healing of wounds, nose bleeds, high blood pressure, pain (including pain in legs, stomach and/ or chest).
Żieda fl- enzimi tal- fwied, sturdament, ma tkunx tista ’ torqod, konfużjoni, tħossok bla nifs, rimettar (bi jew mingħajr demm), stitikezza, demm fl- awrina tiegħek, diffikultà biex tagħmel l- awrina, raxx, ħakk (urtikarja), livelli baxxi ta ’ potassium fid- demm, sensazzjoni ta ’ ħruq meta tagħmel l- awrina kif ukoll b’ żieda fil- frekwenza ta ’ meta tagħmel l- awrina, fejqan bil- mod tal- feriti, ħruġ ta ’ demm mill - imnieħer, pressjoni tad- demm għolja, uġigħ (li jinkludi uġigħ fir- riġlejn, fl- istonku u/ jew fis- sider).
Rare side effects (likely to affect between 1 in 1,000 and 1 in 10,000 patients):
Effetti sekondarji rari (li x’ aktarx li ser jaffettwaw bejn 1 minn kull 1, 000 u 1 minn kull 10, 000 pazjent):
Anti-hirudin antibodies have been detected upon re-exposure
Antikorpi anti- hirudin kienu osservati ma ’ l- espożizzjoni mill- ġdid
Isolated cases of fatal bleeding have been reported.
Ħruġ tad- demm fatali kienu irrapportati f’ każijiet iżolati.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib, lin- ners jew lill- ispiżjar tiegħek.
HOW TO STORE REVASC
KIF TAĦŻEN REVASC
Do not use Revasc after the expiry date which is stated on the carton and the pack.
Tużax Revasc wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- pakkett.
Keep the vial and ampoule in the outer carton.
Żommu l- kunjett u l- ampulla fil- kaxxa tal- kartun ta ’ barra.
After reconstitution, immediate use is recommended.
Wara li ssir it- taħlita, l- użu immedjat huwa irrakkomandat.
However, the in-use stability has been demonstrated for 24 hours between 2°C and 8°C (in a refrigerator).
Madankollu, l- istabbiltà tiegħu waqt l- użu ntweriet li tibqa ’ tajba sa 24 siegħa, meta jinżamm bejn 2oC u 8oC (fil- friġġ).
Do not use Revasc if you notice that the solution for injection contains visible particles.
24 M’ għandekx tuża Revasc jekk tara li t- taħlita għall- injezzjoni għandha frak viżibbli.