natgillin/translations-raw huggingface dataset:
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged problems) and the rate of deep vein thrombosis (the formation of a blood clot in one of the deep veins of the body, usually in the leg).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged trombotičnih dogodkov (težav, ki jih povzročajo krvni strdki) in pogostost globoke venske tromboze (nastanek krvnega strdka v eni od globokih ven, najpogosteje v nogi).
The Committee for Medicinal products for Human Use (CHMP) decided that Revasc’ s benefits are greater than its risks to prevent deep vein thrombosis in patients undergoing hip or knee replacement.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Revasc pri preprečevanju globoke venske tromboze pri bolnikih, pri katerih se bo opravila menjava kolka ali kolena, večje od z njim povezanih tveganj.
Powder: vial (glass) Solvent: ampoule (glass)
Prašek: viala (steklena) Vehikel: ampula (steklena)
15 mg Solvent:
15 mg Vehikel:
2 vials + 2 ampoules
2 viali + 2 ampuli
Revasc 15mg/ 0.5ml powder and solvent for solution for injection
Revasc 15 mg/ 0, 5 ml prašek in vehikel za raztopino za injiciranje
After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml
Po rekonstituciji ena viala vsebuje 15 mg ** desirudina * na 0, 5 ml.
* 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.
* pridobljen s tehnologijo rekombinantne DNA v celicah kvasovk. ** ustreza približno 270. 000 antitrombinskim enotam (ATE) ali 18. 000 ATE na mg desirudina po Drugem mednarodnem standardu SZO za alfa- trombin.
Instructions for the preparation of Revasc are provided in section 6.6.
Navodila za pripravo Revasca so v poglavju 6. 6.
Currently, there is no clinical experience to support the use of desirudin beyond 12 days.
Trenutno ni kliničnih izkušenj, ki bi govorile v prid več kot 12- dnevni uporabi desirudina.
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 je kontraindiciran pri bolnikih s hudo okvaro ledvic (očistek kreatinina manj kot 30 ml/ min, kar ustreza kreatininu v serumu > 2, 5 mg/ dl ali 221 μmol/ l; glejte poglavje 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.
Pri bolnikih z blago ali zmerno okvaro ledvic (očistek kreatinina med 31 in 90 ml/ min, glejte poglavje 4. 4) je treba kontrolirati aktivirani parcialni tromboplastinski čas (aPTČ).
2 Patients with liver impairment
2 Bolniki z okvaro jeter
Desirudin is contraindicated in severe hepatic impairment (see section 4.3).
Pri hudi okvari jeter je desirudin kontraindiciran (glejte poglavje 4. 3).
In patients with mild to moderate liver impairment (see section 4.4) aPTT monitoring is recommended.
Pri bolnikih z blago do zmerno okvaro jeter (glejte poglavje 4. 4) je priporočljivo kontrolirati aPTČ.
- with hypersensitivity to the active substance or to any of the excipients
- s preobčutljivostjo za zdravilno učinkovino ali katerokoli pomožno snov,
- with active bleeding and/ or irreversible coagulation disorders
- z aktivno krvavitvijo in/ ali ireverzibilnimi motnjami koagulacije,
- with severe renal and hepatic impairment
- s hudo okvaro ledvic ali jeter,
- during pregnancy (see section 4.6)
- med nosečnostjo (glejte poglavje 4. 6),
Anaphylaxis:
Anafilaksa:
Revasc may cause allergic reactions including anaphylaxis and shock (see section 4.8).
Revasc lahko povzroči alergijske reakcije, vključno z anafilaksijo in šokom (glejte poglavje 4. 8).
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 je treba previdno uporabljati pri stanjih, ki zvečujejo tveganje za krvavitve, npr. večjih operacijah, biopsiji ali punkciji nestisljive žile v zadnjem mesecu, anamnezi hemoragičnega inzulta, intrakranialne ali intraokularne krvavitve, vključno z diabetično (hemoragično) retinopatijo, ishemičnem cerebralnem inzultu v zadnjih 6 mesecih, znani motnji hemostaze (prirojeni ali pridobljeni, npr. hemofiliji, bolezni jeter) ali anamnezi krvavitve v prebavilih ali pljučih v preteklih 3 mesecih.
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.
Med uporabo desirudina pri bolnikih z zvečanim tveganjem za krvavitvene zaplete, blago do zmerno disfunkcijo jeter in/ ali blago do zmerno okvaro ledvic je treba nadzirati aPTČ; najvišji aPTČ ne sme preseči dvakratne kontrolne vrednosti.
Desirudin should be used with care in patients receiving anticoagulants, and/ or platelet inhibitors, and/ or non-steroidal anti-inflammatory medicinal products.
Desirudin je treba previdno uporabljati pri bolnikih, ki dobivajo antikoagulante in/ ali zaviralce agregacije trombocitov in/ ali nesteroidne antirevmatike.
Monitoring for evidence of bleeding is advised (see section 4.5).
Priporočeno je spremljanje glede morebitnih znakov krvavitve (glejte poglavje 4. 5).
Activated partial thromboplastin time (aPTT) should be monitored in patients with increased risk of bleeding and/ or renal or hepatic impairment.
Aktivirani parcialni tromboplastinski čas (aPTČ) je treba kontrolirati pri bolnikih z večjim tveganjem za krvavitve in/ ali okvaro ledvic ali jeter.
If necessary, therapy with desirudin should be interrupted until aPTT falls to less than
Če je potrebno, je treba zdravljenje z desirudinom prekiniti, dokler se
3 twice the control at which time treatment with desirudin can be resumed at a reduced dose (see also section 4.5).
3 aPTČ ne zniža na manj kot dvakratno normalno vrednost; ko se to zgodi, je zdravljenje z desirudinom mogoče znova začeti z manjšim odmerkom (glejte tudi poglavje 4. 5).
If co-administration cannot be avoided, close clinical and laboratory monitoring should be conducted (see section 4.4).
Če se sočasni uporabi ni mogoče izogniti, je potrebno natančno klinično in laboratorijsko nadziranje (glejte poglavje 4. 4).
The effects of desirudin and unfractionated heparins on prolongation of aPTT have been shown to be additive (see section 4.4).
Ugotovljeno je, da so učinki desirudina in nefrakcioniranih heparinov na podaljšanje aPTČ aditivni (glejte poglavje 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.
Med takšna zdravila spadajo acetilsalicilna kislina in nesteroidni antirevmatiki, tiklopidin in klopidogrel, antagonisti glikoproteina IIb/ IIIa (abciksimab, eptifibatid, tirofiban) in iloprost.
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).
Ta učinek je treba upoštevati pri oceni celotnega koagulacijskega statusa bolnika med prehodom (glejte poglavje 4. 2).
Revasc is contraindicated in pregnancy (see section 4.3).
Revasc je kontraindiciran med nosečnostjo (glejte poglavje 4. 3).
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).
Opisani so bile naslednji povezani neželeni učinki, našteti spodaj po organskih sistemih, znotraj posameznih skupin pogostnosti pa so neželeni učinki navedeni po padajoči resnosti: pogosto (≥ 1/ 100 do < 1/ 10); občasno (≥ 1/ 1. 000 do < 1/ 100); redko (≥ 1/ 10. 000 do < 1/ 1. 000).
Investigations Uncommon:
Preiskave občasno:
Increase in serum transaminases
porast serumskih transaminaz
4 Blood and the lymphatic system disorders Common:
Bolezni krvi in limfatičnega sistema pogosto:
Nervous system disorders Uncommon:
občasno:
Dizziness, insomnia, confusion
omotica, nespečnost, zmedenost
Respiratory, thoracic and mediastinal disorders Uncommon:
Bolezni dihal, prsnega koša in mediastinalnega prostora občasno:
Uncommon:
4 Bolezni prebavil pogosto: občasno:
Nausea Haematemesis, vomiting, constipation
navzea hematemeza, bruhanje, zaprtje
Renal and urinary disorders Uncommon:
občasno:
Haematuria, urinary retention
hematurija, zastoj urina
Skin and subcutaneous tissue disorders Uncommon:
Bolezni kože in podkožja občasno:
Rash, urticaria
izpuščaj, koprivnica
Metabolism and nutrition disorders Uncommon:
Presnovne in prehranske bolezni občasno:
Infections and infestations Uncommon:
Infekcijske in parazitske bolezni občasno:
Urinary tract infection, cystitis
okužbe sečil, cistitis
Uncommon:
Poškodbe in zastrupitve in zapleti pri posegih pogosto: občasno:
Wound secretion Impaired wound healing
sekrecija iz rane upočasnjeno celjenje ran
Uncommon:
pogosto: občasno:
Hypotension, deep thrombophlebitis Epistaxis, hypertension
hipotenzija, globoki tromboflebitis epistaksa, hipertenzija
Uncommon:
Splošne težave in spremembe na mestu aplikacije pogosto: občasno:
Fever, injection site mass, haematomas, oedema in legs Pain in legs, pain, abdominal and chest pain
vročina, oteklina na mestu injiciranja, hematomi, edemi spodnjih udov bolečine v spodnjih udih, bolečine, bolečine v trebuhu in prsih
Immune system disorders Common:
Bolezni imunskega sistema pogosto:
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.
Alergijske reakcije so bile v kliničnih preskušanjih opisane pri enakem deležu (1, 6%) bolnikov, zdravljenih z desirudinom (n = 2. 367) ali nefrakcioniranim heparinom (n = 1. 134), ne glede na vzrok.
Rare:
redko:
Anti-hirudin antibodies have been detected upon re-exposure to desirudin in clinical trials.
Neželeni učinki, preskušanjih, so
Adverse reactions irrespective of trial drug relationship reported during clinical trials were bleeding episodes, oliguria, hyperpyrexia and joint dislocation.
ki so bili ne glede na povezanost s proučevanim zdravilom opisani v kliničnih bili krvavitve, oligurija, hiperpireksija in izpah sklepa.
If necessary, plasma expanders and/ or blood transfusion may be used.
Če je potrebno, je mogoče uporabiti plazemske ekspanderje in/ ali transfuzijo krvi.
5 5.1 Pharmacodynamic properties
5. 1 Farmakodinamične lastnosti
Anticoagulant, ATC code:
Farmakoterapevtska skupina: antitrombotik, oznaka ATC:
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.
Povprečno največje podaljšanje aPTČ, opaženo po subkutanem (s. c.) injiciranju 15 mg desirudina dvakrat na dan, je bilo okrog 1, 4- kratnik izhodiščne vrednosti.
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.
V terapevtskih serumskih koncentracijah ne vpliva na druge encime hemostatskega sistema, npr. faktorje IXa, Xa, kalikrein, plazmin, tPA ali aktivirani protein C.
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.
Poleg tega ne kaže nobenih učinkov na druge serinske proteaze, npr. na prebavna encima tripsin ali himotripsin, ali na aktiviranje komplementa po klasični ali alternativni poti.
(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).
V dveh kontroliranih dvojno slepih kliničnih preskušanjih je bil celotni delež trombemboličnih dogodkov pri bolnikih, zdravljenih s 15 mg desirudina subkutano dvakrat na dan (n = 370), polovico manjši kot pri bolnikih, zdravljenih s standardnim odmerkom nefrakcioniranega heparina (n = 396) (p < 0, 0001); delež proksimalne globoke venske tromboze je bil le petino tistega pri heparinu (p < 0, 0001).
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).
Povprečni čas absorpcije subkutanega (s. c.) desirudina je po odmerku 0, 1 mg/ kg 4, 1 ure, po 0, 3 mg/ kg 4, 5 ure in po 0, 5 mg/ kg 5, 4 ure (celotno povprečje = 4, 6 ure).
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.
Po uporabi posamičnih subkutanih odmerkov od 0, 1 do 0, 75 mg/ kg se koncentracija desirudina v plazmi hitro zviša do najvišje ravni (Cmax) v času od 1 do 3 ur.
Desirudin is distributed in the extracellular space with a distribution volume at steady state of 0.251/ kg independently of the dose.
Desirudin se distribuira v zunajcelični prostor z distribucijskim volumnom v stanju dinamičnega ravnotežja 0, 25 l/ kg, neodvisno od odmerka.
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.
V prvi fazi je izginjanje desirudina iz plazme hitro: približno 90% intravenskega (i. v.) bolusnega odmerka izgine iz obtoka v 2 urah po injekciji.
A slower terminal elimination phase follows with a dose-independent mean terminal elimination half-life of 2 to 3 h.
Sledi počasnejša faza terminalne eliminacije, ki ima od odmerka neodvisen povprečen razpolovni čas terminalne eliminacije od 2 do 3 ure.
The mean residence times are 1.7-2 h and 6-7 h after IV and SC administration, respectively.
Povprečni rezidenčni čas po intravenski uporabi je od 1, 7 do 2 uri in po subkutani uporabi od 6 do 7 ur.
The total urinary excretion of unchanged desirudin amounts to 40-50% of the administered dose.
Skupna količina v urinu izločenega nespremenjenega desirudina predstavlja od 40 do 50% uporabljenega odmerka.
Metabolites lacking one or two C-terminal amino acids constitute a minor proportion of the material recovered from urine (< 7%).
Presnovka brez ene ali dveh C- terminalnih aminokislin predstavljata zelo majhen (< 7%) delež snovi, izločenih v urinu.
Hepatic elimination of desirudin or the thrombin- desirudin complex does not appear to be significant.
Kaže, da jetrna eliminacija desirudina in kompleksa trombin- desirudin ni pomembna.
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.
1, 95– 2, 20 ml/ min/ kg) in ni odvisen od odmerka.
magnesium chloride sodium hydroxide
magnezijev klorid natrijev hidroksid
mannitol (E 421) water for injections
manitol (E 421) voda za injekcije
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 praška v viali (steklo tipa I) z zamaškom (butilna guma), prekritim s filmom (fluoropolimer) na strani zdravila, in 0, 5 ml vehikla v ampuli (steklo tipa I).
Pack size of 1, 2 or 10.
1, 2 in 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.
Za pripravo rekonstituirane vodne raztopine je treba 0, 5 ml priloženega vehikla z manitolom v aseptičnih pogojih dodati v vialo s praškom za raztopino za injiciranje.
The reconstituted solution should be used as soon as possible (see section 6.3 above).
Pripravljeno raztopino je treba uporabiti čim prej (glejte poglavje 6. 3 zgoraj).
Any unused product or waste material should be disposed in accordance with local requirements.
7 Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Canyon Pharmaceuticals Limited 20-22 Bedford Row London WC1R 4JS United Kingdom
Canyon Pharmaceuticals Limited, 20- 22 Bedford Row, London WC1R 4JS Velika Britanija
EU/ l/ 97/ 043/ 001 EU/ 1/ 97/ 043/ 002 EU/ 1/ 97/ 043/ 003
EU/ 1/ 97/ 043/ 001 2 viali/ 2 ampuli vehikla EU/ 1/ 97/ 043/ 002 10 vial/ 10 ampul vehikla EU/ 1/ 97/ 043/ 003 1 viala/ 1 ampula vehikla
9 July 1997 Date of latest renewal:
9. julij 1997 Datum zadnjega podaljšanja:
NOVARTIS Pharma AG Lichtstrasse 35 CH-4056 Basel Switzerland
Ime in naslov izdelovalca biološke zdravilne učinkovine NOVARTIS Pharma AG Lichtstrasse 35 CH- 4056 Basel Švica
FOR 2 VIALS (15mg/ vial) AND 2 AMPOULES
ZA 2 VIALI (15 mg/ vialo) IN 2 AMPULI
Revasc 15mg/ 0.5ml powder and solvent for solution for injection Desirudin
Revasc 15 mg/ 0, 5 ml prašek in vehikel za raztopino za injiciranje desirudin
Each vial contains 15mg desirudin with 18,000 ATU/ mg corresponding to approximately 270,000 ATU per vial.
Ena viala vsebuje 15 mg desirudina z 18. 000 ATE/ mg, kar ustreza približno 270. 000 ATE na vialo.
Powder and solvent for solution for injection 15mg of powder in a vial and 0.5ml of solvent in an ampoule
Prašek in vehikel za raztopino za injiciranje 15 mg praška v viali in 0, 5 ml vehikla v ampuli
Pack size of 2
Pakiranje z 2 vialama
Canyon Pharmaceuticals Limited 20-22 Bedford Row London WC1R 4JS United Kingdom
Canyon Pharmaceuticals Limited 20- 22 Bedford Row London WC1R 4JS Velika Britanija
FOR 10 VIALS (15mg/ vial) AND 10 AMPOULES
ZA 10 VIAL (15 mg/ vialo) IN 10 AMPUL
Pack size of 10
Pakiranje z 10 vialami
SPECIAL STORAGE CONDITIONS
15 Zdravilo je priporočljivo uporabiti takoj po pripravi.
FOR 1 VIAL (15mg/ vial) AND 1 AMPOULE
ZA 1 VIALO (15 mg/ vialo) IN 1 AMPULO
Pack size of 1
Pakiranje z 1 vialo
Revasc 15 mg/ 0.5 ml Powder for injection Desirudin Subcutaneous use
Revasc 15 mg/ 0, 5 ml prašek za injekcijo desirudin Subkutana uporaba
AMPOULE LABEL:
NALEPKA NA AMPULI:
0.5ml SOLVENT
0, 5 ml VEHIKLA
Revasc 15 mg/ 0.5ml Solvent for parenteral use
Revasc 15 mg/ 0, 5 ml Vehikel za parenteralno uporabo
0.5ml of water for injections with 3% (w/ v) of mannitol
0, 5 ml vode za injekcije s 3- odstotnim (m/ v) manitolom
Revasc 15mg/ 0.5ml powder and solvent for solution for injection Desirudin
Revasc 15 mg/ 0. 5 ml prašek in vehikel za raztopino za injiciranje desirudin
What Revasc is and what it is used for 2.
Kaj je zdravilo Revasc in za kaj ga uporabljamo 2.
Before you use Revasc 3.
Kaj morate vedeti, preden boste uporabili zdravilo Revasc 3.
How to use Revasc 4.
Kako uporabljati zdravilo Revasc 4.
How to store Revasc 6.
Možni neželeni učinki 5 Shranjevanje zdravila Revasc 6.
BEFORE YOU USE REVASC
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO REVASC
You must not be given Revasc
Ne uporabljajte zdravila Revasc
- if you are hypersensitive (allergic) to natural or synthetic hirudin, including desirudin or any of the
- če ste alergični na (preobčutljivi za) naravni ali sintetični hirudin, vključno z desirudinom, ali
other ingredients of Revasc
katerokoli sestavino zdravila Revasc
- if you are bleeding a lot or have any serious bleeding disorder (e. g. haemophilia)
- če veliko krvavite ali imate resno krvavitveno motnjo (npr. hemofilijo)
- if you have serious kidney or liver disease
- če imate resno bolezen ledvic ali jeter
- if you have a heart infection
- če imate okužbo na srcu
- if you have an uncontrolled high blood pressure
- če imate neobvladan visok krvni tlak
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:
To je mogoče, če imate ali ste imeli:
- bleeding disorders or a family history of bleeding disorder
- krvavitvene motnje ali imate družinsko anamnezo o krvavitvenih motnjah
- stomach ulcers or any other bleeding disease of the gut
- razjedo na želodcu ali kakšno drugo bolezen s krvavitvijo v črevo
- history of a stroke, or bleeding within the brain or eye
- anamnezo možganske kapi, krvavitve v možgane ali oko
- a recent operation (including dental surgery) or biopsy or pricking of a blood vessel within the last
- nedavno operacijo (vključno z zobozdravstvenimi operacijami) ali biopsijo ali punktiranje žile v
month
zadnjem mesecu
- recently a brief shortage of blood supply to a part of the brain within the last six months
- nedavno kratko poslabšanje pretoka krvi skozi del možganov v zadnjih šestih mesecih
- if you have recently given birth, fallen, or suffered a blow to the body or head
- če ste nedavno rodili, padli ali doživeli udarec v telo ali glavo
- if you are already taking medicines, especially blood-thinners (see below).
- če že jemljete zdravila, zlasti za redčenje krvi (glejte spodaj)
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.
22 Če za vas velja kaj od zgoraj naštetega, bosta zdravnik ali medicinska sestra kontrolirala vašo kri glede strjevanja in lahko ustrezno spremenita odmerek ali urnik jemanja zdravila.
Children There is no experience with Revasc in children.
Otroci Pri otrocih ni izkušenj z Revascom.
- medicines used to prevent blood-clotting (warfarin, heparin and dicoumarol)
- zdravila, ki se uporabljajo za preprečevanje strjevanja krvi (varfarin, heparin in dikumarol)
- medicines which affect the function of platelets (particles in the blood involved in blood-
- zdravila, ki vplivajo na delovanje trombocitov (krvnih delcev, vpletenih v strjevanje krvi), npr.
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.
za acetilsalicilno kislino, ki jo vsebujejo številna zdravila proti bolečinam in za zniževanje zvišane telesne temperature, in za druge nesteroidne antirevmatike.
Pregnancy and breast-feeding You should not be given Revasc if you are pregnant.
Nosečnost in dojenje Če ste noseči, ne smete dobiti Revasca.
Currently, there is no clinical experience to support the use of Revasc beyond 12 days.
Trenutno ni kliničnih izkušenj, ki bi govorile v prid več kot 12- dnevni uporabi Revasca.
If you need treatment for longer than 12 days, the doctor may switch you to another similar medicine.
Če potrebujete več kot 12- dnevno zdravljenje, vam bo zdravnik morda predpisal drugo podobno zdravilo.
If a dose is missed
23 Če je bil odmerek zdravila Revasc izpuščen
23 If a dose of this medicine is missed, it should be given to you as soon as possible.
Če niste prejeli enega odmerka tega zdravila, ga morate prejeti, čim je mogoče.
Uncommon side effects (likely to affect between 1 in 100 and 1 in 1,000 patients):
Občasni neželeni učinki (verjetno se bodo pojavljali pri 1 od 100 do 1 od 1. 000 bolnikov):