natgillin/translations-raw huggingface dataset:
In particular, you should inform your doctor or pharmacist if you are taking any of the following:  any other immunosuppressive agents excluding ciclosporin or corticosteroids.  antibiotics or antifungal medicines used to treat infection e. g. rifampicin, clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole, ketoconazole and voriconazole.  high blood pressure medicines or medicines for heart problems including nicardipine, verapamil and diltiazem.  anti-epileptic medicines including carbamazepine, phenobarbital, phenytoin.  medicines used to treat ulcers or other gastrointestinal disorders such as cisapride, cimetidine, metoclopramide.  bromocriptine (used in the treatment of Parkinsons’ disease and various hormonal disorders), danazol (used in the treatment of gynaecological disorders), or protease inhibitors (used in the treatment of HIV).  St.
motenj), danazol (za zdravljenje ginekoloških bolezni) ali zaviralce proteaz (za zdravljenje okužb s HIV)
Taking Rapamune with food and drink Rapamune should be taken consistently, either with or without food.
Jemanje zdravila Rapamune skupaj s hrano in pijačo Rapamune jemljite vedno enako – bodisi s hrano ali brez.
Rapamune should not be taken with grapefruit juice.
Ne jemljite ga skupaj s sokom grenivke.
Pregnancy and breast feeding You must use an effective method of contraception during treatment with Rapamune and for 12 weeks after treatment has stopped.
Nosečnost in dojenje Med zdravljenjem z zdravilom Rapamune in še 12 tednov po prenehanju jemanja zdravila morate uporabljati učinkovito zaščito pred zanositvijo.
Patients taking Rapamune should discontinue breast-feeding.
Ni znano, ali Rapamune prehaja v materino mleko, zato morate prenehati z dojenjem, če se zdravite z njim.
Use in children and adolescents There is limited experience of the use of Rapamune in children and adolescents.
Uporaba pri otrocih in mladostnikih Izkušnje z uporabo zdravila Rapamune pri otrocih in mladostnikih so omejene.
Driving and using machines No specific studies on the effects of Rapamune on the ability to drive and operate machines have been conducted.
Vpliv na sposobnost upravljanja vozil in strojev Študije o vplivu zdravila Rapamune na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
Although Rapamune treatment is not expected to affect your ability to drive, if you have any concerns please consult your doctor.
Čeprav ni pričakovati, da bi Rapamune vplival na vašo sposobnost vožnje, se posvetujte z zdravnikom, če ste v dvomih.
Important information about some of the ingredients of Rapamune If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Pomembne informacije o nekaterih sestavinah zdravila Rapamune Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Rapamune is for oral use only.
Rapamune je samo za peroralno uporabo.
Usually for an adult your doctor will give you an initial dose of 6 mg at the time of the kidney transplant operation.
Če ste odrasla oseba, vam bo zdravnik običajno predpisal začetni odmerek 6 mg v času operacije presaditve ledvice.
Then you will need to take 2 mg of Rapamune each day, until otherwise directed by your doctor.
Potem boste morali jemati po 2 mg zdravila Rapamune vsak dan (razen če bo zdravnik odločil drugače).
If you take more Rapamune than you should If you have taken more medicine than you were told contact a doctor or go to the nearest hospital emergency department as soon as possible.
Če ste vzeli večji odmerek zdravila Rapamune, kot bi smeli Če ste vzeli večji odmerek zdravila, kot vam je bilo predpisano, pojdite čimprej k zdravniku ali na urgentni oddelek najbližje bolnišnice.
Always take the labelled blister with you, even if it is empty.
S seboj vedno vzemite potiskan pretisni omot, tudi če je prazen.
If you forget to take Rapamune If you forget to take Rapamune, take it as soon as you remember, but not within 4 hours of the next dose of ciclosporin.
Če ste pozabili vzeti zdravilo Rapamune Če ste pozabili vzeti Rapamune, ga vzemite takoj, ko se spomnite, vendar ne manj kot 4 ure pred naslednjim odmerkom ciklosporina.
Do not take a double dose to make up for a forgotten dose, and always take Rapamune and ciclosporin approximately 4 hours apart.
Rapamune in ciklosporin vzemite vedno vsaj 4 ure narazen.
Possible side effects of Rapamune are listed according to the following categories:
Možni neželeni učinki zdravila Rapamune so navedeni po naslednjih kategorijah:
Fluid collection around the kidney, swelling of the extremities, fever, pain
nabiranje tekočine okrog ledvic, otekanje okončin, zvišana telesna temperatura, bolečina
Impaired healing (this may include separation of the layers of a surgical wound or suture line), swelling, infections (including life-threatening infections)
slabše celjenje ran (npr. ločitev plasti kirurške rane ali šiva po operaciji), oteklina, okužbe (vključno s smrtno nevarnimi okužbami)
 Nervous system disorders:
• Bolezni živčevja:
 Blood vessel disorders:
• Žilne bolezni
 Immune system disorders:
• Bolezni imunskega sistema
 Metabolism and nutrition disorders:
• Presnovne in prehranske motnje:
disorders:
• Bolezni mišično- skeletnega sistema in vezivnega tkiva:
 Respiratory tract disorders:
• Bolezni dihal, prsnega koša in mediastinalnega prostora:
78 Common:
Pogosti:
Bleeding from the lung.
krvavitve iz pljuč 77
Protein build-up in the air sacs of the lungs that may interfere with breathing
nabiranje beljakovin v zračnih mešičkih v pljučih, kar lahko ovira dihanje
You should see your doctor immediately if you experience symptoms such as swollen face, tongue and/ or pharynx (back of the mouth) and/ or difficulties in breathing (angioedema), or a skin condition whereby the skin can peel off (exfoliative dermatitis).
Nemudoma obiščite svojega zdravnika, če opazite katerega od simptomov kot so otekel obraz, jezik in/ ali žrelo (ozadje ustne votline) in/ ali težave z dihanjem (angioedem) ali kožna bolezen, pri kateri se lahko koža odlušči (eksfoliativni dermatitis).
Keep the blister in the outer carton in order to protect from light.
Pretisni omot shranjujte v kartonski škatli za zagotovitev zaščite pred svetlobo.
Medicines should not be disposed of via wastewater or household waste.
Zdravila na smete odvreči v odpadne vode ali med gospodinjske odpadke.
Each tablet contains 1 mg of sirolimus.
Ena tableta vsebuje 1 mg sirolimusa.
Tablet core: lactose monohydrate, macrogol, magnesium stearate, talc
Jedro tablete: laktoza monohidrat, makrogol, magnezijev stearat, smukec
79 wax: red opacode S-1-15095 (shellac glaze ~45% in ethanol, red iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, simethicone).
Obloga tablete: makrogol, glicerilmonooleat, farmacevtska glazura, brezvodni kalcijev sulfat, mikrokristalna celuloza, saharoza, titanov dioksid, poloksamer 188, α- tokoferol, povidon, karnauba vosek: rdeč opacode S- 1- 15095 (šelak glazura ~ 45% v etanolu, rdeči železov oksid (E172), izopropilalkohol, n- butilalkohol, propilenglikol, amonijev hidroksid, simetikon).
Rapamune is supplied to you as white coloured, triangular-shaped coated tablets marked “ RAPAMUNE 1 mg ” on one side
78 Rapamune je v obliki belih trikotnih obloženih tablet, ki so na eni strani označene z "RAPAMUNE 1 mg".
The tablets are supplied in blister packs of 30 and 100 tablets.
Tablete so v pretisnem omotu v škatli s 30 ali 100 tabletami.
Wyeth Pharmaceuticals New Lane Havant Hampshire PO9 2NG United Kingdom.
Wyeth Pharmaceuticals New Lane Havant Hampshire PO9 2NG Velika Britanija
Portugal Wyeth Lederle Portugal (Farma) Lda.
Wyeth Lederle Portugal (Farma), Lda.
Deutschland Wyeth Pharma GmbH Tel: +49 180 2 29 93 84 Fax: +49 251 204 1128
Suomi/ Finland Kύπρος Deutschland Wyeth Wyeth Hellas (Cyprus Branch) Wyeth Pharma GmbH Puh/ Tel: +358 20 7414 870 AEBE Tel: +49 180 2 29 93 84 Fax: + 358 20 7414 879 Fax: +49 251 204 1128
Suomi/ Finland Wyeth Puh/ Tel: +358 20 7414 870 Fax: +358 20 7414 879
България / România
Do not take Rapamune  if you are allergic (hypersensitive) to sirolimus or any of the other ingredients in the tablet.
- ste alergični (preobčutljivi) na sirolimus ali katerokoli drugo sestavino tablet.
Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including those obtained without a prescription.
81 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, saj lahko nekatera zdravila vplivajo na delovanje zdravila Rapamune.
82 Rapamune.
verapamil in diltiazem,
83 3.
82 3.
Usually for an adult your doctor will give you an initial dose of 6mg at the time of the kidney transplant operation.
Če ste odrasla oseba, vam bo zdravnik običajno predpisal začetni odmerek 6 mg v času operacije presaditve ledvice.
When taken with medicines called calcineurin inhibitors (ciclosporin or tacrolimus), Rapamune may increase the risk of kidney damage with low blood platelets and low red blood cell counts with or without rash (thrombocytopenic purpura/ haemolytic uraemic syndrome).
Kadar jemljete zdravilo Rapamune sočasno z zdravili imenovanimi zaviralci kalcinevrina (ciklosporin ali takrolimus) se lahko poveča tveganje za okvaro ledvic z zmanjšanjem števila krvnih ploščic in rdečih krvničk, z ali brez izpuščaja (trombocitopenična purpura, hemolitično uremični sindrom).
Very common: more than 1 per 10 Common: less than 1 per 10 but more than 1 per 100 Uncommon: less than 1 per 100 but more than 1 per 1000 Rare: less than 1 per 1000
manj kot 1 od 10, vendar več kot 1 od 100 bolnikov manj kot 1 od 100, vendar več kot 1 od 1. 000 bolnikov manj kot 1 od 1. 000 bolnikov
85 Common:
Pogosti:
Bleeding from the lung.
krvavitve iz pljuč 84
Do not use after the expiry date which is stated on the carton after EXP:
Zdravila Rapamune ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do:.
Each tablet contains 2 mg of sirolimus.
Ena tableta vsebuje 2 mg sirolimusa.
Tablet Coating: macrogol, glyceryl monooleate, pharmaceutical glaze, anhydrous calcium sulphate, microcrystalline cellulose, sucrose, titanium dioxide, brown iron oxide (E172), yellow iron oxide (E172), poloxamer 188,  -tocopherol, povidone, carnauba wax: red opacode S-1-15095 (shellac glaze ~45% in
Obloga tablete: makrogol, glicerilmonooleat, farmacevtska glazura, brezvodni kalcijev sulfat, mikrokristalna celuloza, saharoza, titanov dioksid, rjavi železov oksid (E172), rumeni železov oksid (E172), poloksamer 188, α- tokoferol, povidon, karnauba vosek: rdeč opacode S- 1- 15095 (šelak glazura ~ 45% v etanolu, rdeč železov oksid (E172), izopropilalkohol, n- butilalkohol, propilenglikol, amonijev hidroksid, simetikon).
What Rapamune looks like and contents of the pack
85 Izgled zdravila Rapamune in vsebina pakiranja
Rapamune is supplied to you as yellow to beige coloured, triangular-shaped coated tablets marked “ RAPAMUNE 2 mg ” on one side
Rapamune je v obliki rumenih do bež trikotnih obloženih tablet, ki so na eni strani označene z "RAPAMUNE 2 mg".
Ísland Icepharma hf Tel: +354 540 8000 Fax: +354 540 8001
Ísland Icepharma hf Tel: +354 540 8000
Deutschland Wyeth Pharma GmbH Tel: +49 180 2 29 93 84 Fax: +49 251 204 1128
Deutschland Wyeth Pharma GmbH Tel: +49 180 2 29 93 84
Kύπρος Wyeth Hellas (Cyprus Branch) AEBE T: +357 22 817690 Φαξ: +357 22 751855
Kύπρος Wyeth Hellas (Cyprus Branch) AEBE
87 Eesti/ Latvija/ Lietuva/ Österreich / Slovenija/ България / România Wyeth-Lederle Pharma GmbH Tel/ Tãlr/ Teл: +43 1 89 1140 Faks/ Fakss/ Faksas/ Fax/факс: +43 1 89 114600
Sverige Magyarország Eesti/ Latvija/ Lietuva / Wyeth AB Wyeth Kft Österreich / Slovenija / Tel: +46 8 470 3200 Tel: +36 1 453 33 30 България / România Wyeth- Lederle Pharma GmbH Tel/ Tãlr/ Teл: +43 1 89 1140 Faks/ Fakss/ Faksas/ Fax/ факс: +43 1 89 114600
T : +30 2 10 99 81 600 Φαξ: +30 2 10 99 21 994
Tel: +44 1628 415330 Tel: +35621 344610 Tηλ: +30 2 10 99 81 600 Fax: +44 1628 414802 Fax: +35621 341087 Φαξ: +30 2 10 99 21 994
United Kingdom Wyeth Pharmaceuticals Tel: +44 1628 415330 Fax: +44 1628 414802
Nederland España Wyeth Pharmaceuticals B. V.
España Wyeth Farma S. A.
Wyeth Farma S. A.
Tel: +34 91 334 65 65 Fax: +34 91 663 65 53
Tel: +31 23 567 2567 Tel: +34 91 334 65 65 Fax: +31 23 567 2599 Fax: +34 91 663 65 53
What is Rapilysin?
Kaj je zdravilo Rapilysin?
Rapilysin is a vial containing a white powder to be dissolved in a solution for injection.
Zdravilo Rapilysin je bel prašek v viali za pripravo raztopine za injiciranje.
Rapilysin contains the active substance reteplase.
Rapilysin vsebuje zdravilno učinkovino reteplazo.
Rapilysin is used in patients who have had a heart attack (suspected acute myocardial infarction) to help dissolve the blood clots (thrombolysis) that have caused the heart attack.
Zdravilo Rapilysin se uporablja pri bolnikih, ki so imeli srčni napad (domnevni akutni miokradni infarkt) za raztapljanje krvnih strdkov (trombolizo), ki so povzročili srčni napad.
It is given within the 12 hours following the attack.
Daje se v 12 urah po napadu.
Doctors who are experienced in using medicines that affect blood clotting should be prescribing Rapilysin.
Rapilysin naj predpisujejo zdravniki, ki imajo izkušnje z uporabo zdravil z učinkom na strjevanje krvi.
Treatment with Rapilysin should be started as soon as possible after the start of heart attack symptoms.
Zdravljenje z zdravilom Rapilysin se mora uvesti čim prej po pojavu simptomov srčnega napada.
Each injection is given intravenously (into a vein) slowly but within 2 minutes.
Obe injekciji se dajeta intravensko (v veno), in sicer počasi v trajanju največ 2 minut.
Rapilysin is given with other medicines that prevent clotting (aspirin, heparin), to stop any reclotting taking place.
Rapilysin se daje hkrati z drugimi zdravili za preprečevanje strjevanja krvi (aspirin, heparin) z namenom preprečiti ponovno strjevanje krvi.
But Raplilysin and heparin must not be given in the same syringe, as this causes the injection solution to becoming cloudy.
Pri tem zdravila Rapilysin in heparina ne smemo dati z isto brizgo, saj lahko to povzroči motnost raztopine za injiciranje.
Rapilysin is a thrombolytic (dissolves blood clots).
Rapilysin je trombolitik (raztaplja krvne strdke).
The active substance in Rapilysin, reteplase, is a copy of a natural enzyme, t-PA, but modified to give it faster onset and longer duration of action.
Zdravilna učinkovina zdravila Rapilysin, reteplaza, je kopija naravnega encima t- PA, ki je bila modificirana tako, da omogoča hitrejše in daljše učinkovanje zdravila.
It is made by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
Proizvaja se po metodi, imenovani » tehnologija rekombinantne DNA «: encim proizvede bakterija, ki je prejela gen (DNA), s pomočjo katerega postane sposobna tvoriti encim.
Reteplase activates the production of an enzyme, plasmin, that breaks up clots.
Reteplaza aktivira tvorbo encima plazmin, ki razkraja strdke.
Rapilysin dissolves the blood clots and helps restore the normal blood flow to the heart.
Zdravilo Rapilysin raztaplja krvne strdke in pomaga pri vzpostavljanju normalnega pretoka krvi do srca.
The effectiveness of Rapilysin has been studied in more than 21,000 patients in 4 studies.
Učinkovitost zdravila Rapilysin so raziskali v 4 študijah, ki so zajemale več kot 21. 000 bolnikov.
Rapilysin has been compared with other medicines used in thrombolysis: streptokinase (6,000 patients) or alteplase (about 15,000 patients).
Rapilysin so primerjali z drugimi zdravili, ki se uporabljajo pri trombolizi: streptokinazo (6. 000 bolnikov) ali alteplazo (okoli 15. 000 bolnikov).
The studies examined the rate of death 35 days after treatment (30 in one study), heart failure, and strokes.
V študijah so ugotavljali stopnjo umrljivosti 35 dni po zdravljenju (30 v eni študiji), odpovedi srca in kapi.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int  EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Rapilysin shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo Rapilysin izkazalo med raziskavami?
Rapilysin reduced the incidence of heart failure better than streptokinase and was equally effective in reducing death, and as effective as alteplase at preventing death and strokes.
Zdravilo Rapilysin je v večji meri zmanjšalo pogostost odpovedi srca kot streptokinaza in je bilo enako učinkovito pri zmanjševanju umrljivosti ter tako učinkovito kot alteplaza pri preprečevanju smrti in kapi.
The main side effect of Rapilysin is bleeding (such as a bruise at the site of injection).
Glavni neželeni učinek zdravila Rapilysin so krvavitve (kakor tudi hematom na mestu vboda).
If bleeding occurs in the brain, this can lead to a stroke, which can be life-threatening.
V primeru krvavitev v možganih lahko pride do kapi, ki je lahko življenjsko nevarna.
Other less common side effects are chest pains, low blood pressure and shortness of breath.
Ostali manj pogosti neželeni učinki so bolečine v prsih, nizek krvni tlak in oteženo dihanje.
For the full list of all side effects reported with Rapilysin, please see the Package Leaflet.
Celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Rapilysin, najdete v Navodilih za uporabo.
Rapilysin should not be used in people who may be hypersensitive (allergic) to reteplase or any of the other ingredients, who are at risk of bleeding because of high blood pressure, previous bleeding, etc., who have severe liver or kidney disease or who are taking oral anticoagulants.
Zdravila Rapilysin ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) reteplazo ali katerokoli drugi sestavino, pri katerih obstaja tveganje za pojav krvavitev zaradi visokega krvnega tlaka, predhodnih krvavitev itd., ali imajo hudo obolenje jeter ali ledvic ali jemljejo peroralne antikoagulante.
The Committee for Medicinal Products for Human Use (CHMP) decided that Rapilysin’ s benefits are greater than its risks for patients requiring thrombolytic therapy of acute myocardial infarction.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so za bolnike, ki potrebujejo trombolitično zdravljenje akutnega miokardnega infarkta, koristi zdravila Rapilysin večje od z njim povezanih tveganj.
They recommended that Rapilysin be given marketing authorisation (made available to doctors).
Odbor je za zdravilo Rapilysin priporočil podelitev dovoljenja za promet z zdravilom (s čimer postane zdravilo na voljo zdravnikom).
Other information about Rapilysin:
Druge informacije o zdravilu Rapilysin:
The European Commission granted a marketing authorisation valid throughout the European Union, for Rapilysin on 9 November 2001.
Evropska komisija je dovoljenje za promet z zdravilom Rapilysin, veljavno po celotni Evropski uniji, odobrila dne 9. novembra 2001.
The marketing authorisation holder is Roche Registration Limited.
Imetnik dovoljenja za promet z zdravilom je družba Roche Registration Limited.
The full EPAR for Rapilysin can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Rapilysin je na voljo tukaj.
This summary was last updated in 02-2006
Ta povzetek je bil nazadnje posodobljen februarja 2006.
Pharmaceutical form Route of administration Packaging
Farmacevtska oblika
Powder and solvent for Intravenous use Powder: vial (glass) solution for injection Solvent: prefilled syringe (glass)
Prašek: viala (steklo) Vehikel: napolnjena injekcijska brizga (steklo)
10 U 10 ml (1 U/ ml)
10 enot 10 ml (1 enota/ ml)
2 vials 2 prefilled syringes 2 reconstitution devices and 2 needles 19 G l
2 viali 2 napolnjeni injekcijski brizgi 2 pripomočka za rekonstitucijo in 2 igli 19 G 1
1 vial contains 10 U* reteplase ** in 0.56 g powder 1 prefilled syringe contains 10 ml water for injections.
1 napolnjena injekcijska brizga vsebuje 10 ml vode za injekcije.
* Potency of reteplase is expressed in units (U) by using a reference standard which is specific for reteplase and is not comparable with units used for other thrombolytic agents.
* Jakost reteplaze se izraža v enotah (U) z uporabo referenčnega standarda, ki je specifičen za reteplazo in ni primerljiv z enotami, uporabljenimi za druge trombolitične učinkovine.
** Recombinant plasminogen activator produced in Escherichia coli by recombinant DNA technology.
** Rekombinantni aktivator plazminogena pridobljen s tehnologijo rekombinantne DNA iz bakterije Escherichia coli.
The lyophilisate is reconstituted with the contents of the accompanying syringe (see section 6.6).
Liofilizat rekonstituiramo z vsebino priložene injekcijske brizge (glejte poglavje 6. 6).
In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with 0.9% sodium chloride or 5% dextrose solution prior to and following the Rapilysin injection.
Pri bolnikih, kjer je nujno uporabiti isti kanal, je treba ta kanal (vključno z Y- kanalom) temeljito izprati z 0, 9% fiziološko raztopino ali 5% raztopino dekstroze pred injiciranjem zdravila Rapilysin in po njem.
2 Dosage of Rapilysin
2 Odmerjanje zdravila Rapilysin
Heparin and acetylsalicylic acid should be administered before and following the administration of Rapilysin to reduce the risk of rethrombosis.
Heparin in acetilsalicilno kislino naj se za zmanjšanje tveganja za ponovno trombozo da pred dajanjem zdravila Rapilysin in po njem.
The recommended dose of heparin is 5000 I. U. given as a bolus injection prior to reteplase therapy followed by an infusion of 1000 I. U. per hour starting after the second reteplase bolus.
Priporočeni odmerek heparina je 5000 i. e., dan kot bolusna injekcija pred zdravljenjem z reteplazo, ki mu sledi infuzija 1000 i. e. na uro, ki začne teči po drugem bolusu reteplaze.
Heparin should be administered for at least 24 hours, preferably for 48 – 72 hours, aiming to keep aPTT values 1.5 to 2 times normal.
Heparin je treba dajati vsaj 24 ur, najbolje 48 do 72 ur, da se ohranja vrednosti aktiviranega parcialnega tromboplastinskega časa med 1, 5 - do 2- kratno normalno vrednostjo.
The initial dose of acetylsalicylic acid prior to thrombolysis should be at least 250 mg (250 – 350 mg) followed by 75 – 150 mg/ day at least until discharge.
Začetni odmerek acetilsalicilne kisline, dane pred trombolizo, naj bo vsaj 250 mg (250 do 350 mg), temu pa naj sledi 75 do 150 mg/ dan vsaj do odpusta iz bolnišnice.
Use in children There is no experience in children
Uporaba pri otrocih Izkušenj pri otrocih ni.
Hypersensitivity to reteplase, polysorbate 80 or any of the other ingredients.
Preobčutljivost za reteplazo, polisorbat 80 ali katerokoli pomožno snov.
- known haemorrhagic diathesis
- znana hemoragična diateza,
- patients with current concomitant therapy with oral anticoagulants (e. g. warfarin sodium)
- bolniki, ki se sočasno zdravijo s peroralnimi antikoagulanti (npr. natrijev varfarinat),
- intracranial neoplasm, arteriovenous malformation or aneurysm
- intrakranialni tumor, arteriovenska malformacija ali anevrizma,
- neoplasm with increased bleeding risk
- tumor s povečanim tveganjem za krvavitev,
- history of cerebrovascular accident
- cerebrovaskularni inzult v preteklosti,
- recent (< 10 days) prolonged and vigorous external heart massage
- nedavna (< 10 dni) podaljšana in intenzivna zunanja masaža srca,
- severe uncontrolled hypertension
- huda nenadzorovana hipertenzija,
- active peptic ulceration
- aktivni peptični ulkus,
- portal hypertension (oesophageal varices)
- portalna hipertenzija (varice požiralnika),
- severe liver or renal dysfunction
- hudo okvarjeno delovanje jeter ali ledvic,