natgillin/translations-raw huggingface dataset:
The primary endpoint, a composite of death or cardiogenic shock or congestive heart failure or re-infarction within 30 days, was observed in 12.4% (116/939) of the pharmaco-invasive arm versus 14.3% (135/943) in the primary PCI arm (relative risk 0.86 (0.68-1.09)).
Pogostnost primarnega sestavljenega opazovanega dogodka, ki je zajemal smrt ali kardiogeni šok ali zastojno srčno popuščanje ali ponovni infarkt v 30 dneh, je bila v skupini s farmakoinvazivno strategijo 12,4 % (116/939), v skupini s primarno perkutano koronarno intervencijo pa 14,3 % (135/943) (relativno tveganje 0,86 (0,68-1,09)).
The safety and efficacy of Metalyse in children (below 18 years) have not been established.
Varnost in učinkovitost zdravila Metalyse pri otrocih, starih do 18 let, nista bili dokazani.
The secondary endpoints re-infarction and repeat target vessel revascularisation were significantly increased in the group pre-treated with tenecteplase: reinfarction: 6.1% vs. 3.7% p=0.0279; repeat target vessel revascularisation: 6.6% vs. 3.4% p=0.0041.
Pogostnost sekundarnih opazovanih dogodkov, ponovnega infarkta in ponovne revaskularizacije tarčne žile se je v skupini s predzdravljenjem s tenekteplazo pomembno povečala: ponovni infarkt: 6,1 % glede na 3,7 %, p = 0,0279; ponovna revaskularizacija tarčne žile: 6,6 % glede na 3,4 %, p = 0,0041.
Excipients: L-Arginine, Phosphoric Acid, Polysorbate 20 Trace residue from manufacturing process: Gentamicin The solvent is water for injections.
L-arginin fosforjeva kislina polisorbat 20 ostanek v sledeh iz proizvodnega postopka: gentamicin Vehikel voda za injekcije
The observed incidence of major and of minor non-ICH bleeds were similar in both groups: Pharmaco-invasive (n=944)
Pojavnost velikih in manjših neintrakranialnih krvavitev je bila v obeh skupinah podobna
Intracranial haemorrhage (such as cerebral haemorrhage, cerebral haematoma, haemorrhagic stroke, haemorrhagic transformation stroke, intracranial haematoma, subarachnoid haemorrhage) including associated symptoms as somnolence, aphasia, hemiparesis, convulsion
Bolezni živčevja občasni intrakranialna krvavitev (na primer možganska krvavitev, možganski hematom, hemoragična možganska kap, hemoragična transformacija kapi, intrakranialni hematom, subarahnoidna krvavitev), tudi povezani simptomi, kot so zaspanost, afazija, hemipareza, konvulzija
For intravenous use after reconstitution with 10 ml solvent
Za intravensko uporabo po pripravi z 10 ml vehikla
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 8 ml water for injections
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 8 ml vode za injekcije
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 ml water for injections
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 10 ml vode za injekcije
For intravenous use after reconstitution with 8 ml solvent
Za intravensko uporabo po pripravi z 8 ml vehikla
The benefit of treatment must be evaluated against the potential risks in case of myocardial infarction during pregnancy.
V primeru miokardnega infarkta med nosečnostjo je treba o koristi zdravljenja presoditi glede na možno tveganje.
This leaflet was last approved in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano dne {MM/LLLL} Drugi viri informacij
The active substance is tenecteplase.
Učinkovina je tenekteplaza.
Skin and subcutaneous tissue disorders Common
Bolezni kože in podkožja pogosti ekhimoza
1 vial of powder for solution for injection with 50 mg tenecteplase 1 pre-filled syringe with 10 ml of solvent for parenteral use
1 viala praška za raztopino za injiciranje s 50 mg tenekteplaze 1 napolnjena injekcijska brizga z 10 ml vehikla za parenteralno uporabo
Now solution is ready for iv. bolus injection.
Raztopina je sedaj pripravljena za bolusno injekcijo.
Any known history of haemorrhagic stroke or stroke of unknown origin Known history of ischaemic stroke or transient ischaemic attack in the preceding 6 months Dementia
• znana anamneza ishemične kapi ali prehodne ishemične napade v preteklih 6 mesecih,
Add the water for injections into the vial by pushing the syringe plunger down slowly to avoid foaming.
V vialo dodamo vodo za injekcije, tako da brizgin bat počasi potisnemo navzdol, da preprečimo penjenje.
Intracranial haemorrhage occurred at a rate of 0.93% vs. 0.94% for tenecteplase and alteplase, respectively.
Pogostnost možganskih krvavitev je bila 0,93 % med zdravljenjem s tenekteplazo in 0,94 % med zdravljenjem z alteplazo.
Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
• poškodba osrednjega živčnega sistema v anamnezi (npr. novotvorba, anevrizma, operacija na možganih ali hrbtenici),
Check that the cap of the vial is still intact.
Pregledamo, ali je vialina zaporka nepoškodovana.
As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration: - very common: hypotension, heart rate and rhythm disorders, angina pectoris - common: recurrent ischaemia, cardiac failure, myocardial infarction, cardiogenic shock,
Enako kot za druga trombolitična zdravila navajajo poročila naslednje dogodke, ki so bili posledica miokardnega infarkta ali zdravljenja s trombolitičnim zdravilom ali obeh: - zelo pogosti: hipotenzija, motnje srčne frekvence in srčnega ritma, angina pektoris,
The most common complication encountered during tenecteplase therapy is bleeding.
Med zdravljenjem s tenekteplazo je najpogostnejši zaplet krvavitev.
Metalyse must not be administered to patients with a history of an anaphylactic (i.e. life-threatening) reaction to any of the constituents (i.e. tenecteplase or any excipient) or gentamicin (a trace residue from the manufacturing process).
Zdravila Metalyse ne smemo dajati bolnikom, ki imajo v anamnezi anafilakti6no (življenjsko nevarno) reakcijo na katerokoli sestavino (tenekteplazo ali katerokoli pomožno snov) ali gentamicin (ostanek v sledeh iz proizvodnega postopka).
The reconstituted solution contains 1,000 units (5 mg) tenecteplase per ml.
Pripravljena raztopina vsebuje 1.000 enot (5 mg) tenekteplaze v 1 ml.
The carton contains one vial with a lyophilised powder with 50 mg tenecteplase, one ready for use pre-filled syringe with 10 ml solvent, one vial adapter and one needle.
Škatla vsebuje eno vialo z liofiliziranim praškom s 50 mg tenekteplaze, eno napolnjeno brizgo z 10 ml vehikla, pripravljeno za uporabo, en adapter za vialo in eno iglo.
Death and permanent disability are reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.
Pri bolnikih s kapjo (tudi možgansko krvavitvijo) in drugimi resnimi krvavitvami poročajo o smrtnem izidu in trajni invalidnosti.
The carton contains one vial with a lyophilised powder with 40 mg tenecteplase, one ready for use pre-filled syringe with 8 ml solvent, one vial adapter and one needle.
Škatla vsebuje eno vialo z liofiliziranim praškom s 40 mg tenekteplaze, eno napolnjeno brizgo z 8 ml vehikla, pripravljeno za uporabo, en adapter za vialo in eno iglo.
The concomitant use of heparin anticoagulation may contribute to bleeding.
Sočasno dajanje heparina lahko poveča nevarnost krvavitve.
Metalyse should be reconstituted by adding the complete volume of water for injections from the prefilled syringe to the vial containing the powder for injection.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Metalyse moramo pripraviti tako, da dodamo ves volumen vode za injekcije iz napolnjene brizge v vialo s praškom za injiciranje.
a bleeding disorder or tendency to bleed (haemorrhage) stroke (cerebrovascular event) very high, uncontrolled blood pressure a head injury severe liver disease a stomach ulcer (peptic ulcer) varicose veins in the gullet (oesophageal varices) abnormality of the blood vessels (e.g. an aneurysm) certain tumours inflammation of the lining around the heart (pericarditis); inflammation or infection of the heart valves (endocarditis) dementia;
zelo visok nenadzorovan krvni tlak, poškodbo glave, hudo jetrno bolezen, želodčno razjedo (peptični ulkus), varikozne vene v predelu požiralnika, nepravilnosti krvnih žil (npr. anevrizmo), nekatere vrste tumorjev, vnetje osrčnika (perikarditis); vnetje ali okužbo srčnih zaklopk (endokarditis), demenco;
Antithrombotic adjunctive therapy with platelet inhibitors and anticoagulants should be administered according to the current relevant treatment guidelines for the management of patients with ST-elevation myocardial infarction.
Protitrombotično dodatno zdravljenje z zaviralci trombocitov in antikoagulansi mora biti v skladu z veljavnimi smernicami za zdravljenje bolnikov z miokardnim infarktom in elevacijo spojnice ST. Za koronarne intervencije glejte poglavje 4.4.
Penetrate the vial stopper in the middle with the spike of the vialadapter.
Zamašek viale v sredini prebodemo s konico nastavka za vialo.
one vial of 8,000 units Metalyse powder and one pre-filled syringe containing 8 ml water for injections
- eno vialo z 8.000 enotami praška zdravila Metalyse in - eno napolnjeno brizgo z 8 ml vode za injekcije.
Patients receiving oral anticoagulants: The use of Metalyse may be considered when dosing or time since the last intake of anticoagulant treatment makes residual efficacy unlikely and if appropriate test(s) of anticoagulant activity for the product(s) concerned show no clinically relevant activity on the coagulation system (e.g. INR ≤ 1.3 for vitamin K antagonists or other relevant test(s) for other oral anticoagulants are within the respective upper limit of normal).
ko zaradi odmerjanja antikoagulanta ali časa po njegovem zadnjem odmerku ni verjetno, da bi še trajal njegov rezidualni učinek, in če ustrezni preizkus/(i) antikoagulacijske aktivnosti za zadevno/(a) zdravilo/(a) ne pokaže/(jo) klinično pomembne aktivnosti na koagulacijski sistem
As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration:
Tako kot pri drugih trombolitikih so poročali o naslednjih dogodkih, ki so bili posledica miokardnega infarkta ali dajanja trombolitika:
Rare(may affect up to 1 in 1,000 people): low blood pressure (hypotension) bleeding in the lungs (pulmonary haemorrhage) hypersensitivity (anaphylactoid reactions) e.g. rash, hives (urticaria), difficulty breathing (bronchospasm) bleeding into the area surrounding the heart (haemopericardium) blood clot in the lung (pulmonary embolism)and in the vessels of other organ systems (thrombotic embolisation)
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - nizek krvni tlak (hipotenzija), - krvavitev v pljučih (pljučna hemoragija), - preobčutljivost (anafilaktoidne reakcije) npr. izpuščaj, koprivnica (urtikarija), težave z dihanjem (bronhospazem), krvavitev v osrčnik (hemoperikardij), krvni strdek v pljučih (pljučna embolija)in žilah drugih organskih sistemov (trombotična embolija).
Data on the foetal period are not available.
O plodovem razvoju ni na voljo podatkov.
Sterile vial adapter.
Sterilni nastavek za vialo.
Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65, 88397 Biberach/Riss Germany
KG Birkendorfer Strasse 65, 88397 Biberach/Riss Nemčija
Common (may affect up to 1 in 10 people): bleeding at the injection or puncture site nosebleeds genitourinary bleeding (you may notice blood in your urine) bruising gastro-intestinal bleeding (e.g. bleeding from the stomach or bowel)
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): krvavitev na mestu vboda ali punkcije, krvavitve iz nosu, krvavitev v rodilih ali sečilih (opazite lahko kri v seču), modrice, krvavitev v prebavilih (npr. krvavitev v želodcu ali črevesu).
pericarditis, pulmonary oedema - uncommon: cardiac arrest, mitral valve incompetence, pericardial effusion, venous thrombosis,
pljučni edem, - občasni: srčni zastoj, inkompetenca mitralne zaklopke, izliv v perikardij, venska tromboza,
one vial of 10,000 units Metalyse powder and one pre-filled syringe containing 10 ml water for injections.
- eno vialo z 10.000 enotami praška zdravila Metalyse in - eno napolnjeno brizgo z 10 ml vode za injekcije.
Metalyse is a powder and solvent for solution for injection.
Zdravilo Metalyse je v obliki praška in vehikla za pripravo raztopine za injiciranje.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution with 10 ml solvent
POSTOPEK IN POT(I) UPORABE ZDRAVILA za intravensko uporabo po pripravi z 10 ml vehikla
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution with 8 ml solvent
POSTOPEK IN POT(I) UPORABE ZDRAVILA za intravensko uporabo po pripravi z 8 ml vehikla
Composite death, shock, congestive heart failure, re-infarction
Sestavljeni dogodek: smrt, šok, zastojno srčno popuščanje, ponovni infarkt Umrljivost iz vseh vzrokov
What Metalyse contains
Kaj vsebuje zdravilo Metalyse
The use of rigid catheters as well as intramuscular injections and non-essential handling of the patient should be avoided during treatment with tenecteplase.
Med zdravljenjem s tenekteplazo se je treba izogibati uporabi togih katetrov, intramuskularnih injekcij in vseh ukrepov, ki niso nujno potrebni.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
No sustained antibody formation to the tenecteplase molecule has been observed after treatment.
Po zdravljenju niso zasledili trajnega nastajanja protiteles proti molekuli tenekteplaze.
Your doctor will give you the medicinal product to prevent blood clotting in addition to Metalyse, as soon as possible after your chest pain starts.
Zdravnik vam bo ob zdravilu Metalyse čimprej po pojavu bolečine v prsih, predpisal še zdravilo, ki prepreči nastajanje krvnih strdkov.
Nausea, vomiting
neznana siljenje na bruhanje, bruhanje
Directly before the solution will be administered, invert the vial with the syringe still attached, so that the syringe is below the vial.
Tik preden raztopino injiciramo, obrnemo vialo s pritrjeno brizgo tako, da je brizga pod njo.
Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks Acute pericarditis and/or subacute bacterial endocarditis Acute pancreatitis
• podaljšana kardiopulmonalna reanimacija (> 2 minuti) v preteklih 2 tednih,
Each vial 40 mg tenecteplase.
Ena viala vsebuje 40 mg tenekteplaze.
Arterial aneurysm and known arterial/venous malformation Neoplasm with increased bleeding risk
• arterijska anevrizma in znana arterijska ali venska nepravilnost,
Death or permanent disability may occur following bleeding in the brain or other serious bleeding events bleeding in the eyes (eye haemorrhage)
Srčni zastoj je lahko življenjsko nevaren, notranja krvavitev v trebušni votlini (retroperitonealna krvavitev), krvavitev v možganih (cerebralna hemoragija); krvavitev v možganih in druge resne krvavitve lahko povzročijo smrt ali trajno invalidnost, krvavitev v očeh (očesna hemoragija).
Your doctor will give Metalyse as soon as possible after your chest pain starts as a single dose.
Zdravnik vam bo vbrizgal zdravilo Metalyse v enem odmerku, kolikor je možno hitro po pojavu bolečine v prsnem košu.
if you have previously had a sudden life-threatening allergic reaction (severe hypersensitivity) to the active ingredient tenecteplase, to gentamicin (a trace residue from the manufacturing process) or any of the other ingredients of Metalyse.
Zdravila Metalyse vam zdravnik ne bo predpisal če ste v preteklosti imeli nenadno življenjsko nevarno alergijsko reakcijo (hudo preobčutljivost) na učinkovino tenekteplazo, gentamicin (ostanek v sledeh iz proizvodnega postopka) ali katerokoli drugo sestavino zdravila Metalyse.
Very common(may affect more than 1 in 10 people): Low blood pressure (hypotension) Irregular heart beat
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): nizek krvni tlak (hipotenzija), neredno bitje srca, bolečina v prsnem košu (angina pektoris).
Significant bleeding disorder either at present or within the past 6 months Patients receiving effective oral anticoagulant treatment, e.g. warfarin sodium (INR > 1.3) (see section 4.4, subsection “Bleeding”)
• bolniki, ki prejemajo učinkovite peroralne antikoagulante, npr. natrijev varfarinat (INR > 1,3)
Each vial contains 8,000 units (40 mg) tenecteplase.
Ena viala vsebuje 8.000 enot (40 mg) tenekteplaze.
Body temperature increased Injury, poisoning and procedural complications Not known
Preiskave redki znižanje krvnega tlaka neznana povečanje telesne temperature Poškodbe in zastrupitve in zapleti pri posegih neznana maščobna embolija, ki ima lahko posledice v prizadetih organih
Each vial 50 mg tenecteplase.
Ena viala vsebuje 50 mg tenekteplaze.
Metalyse 8,000 units powder and solvent for solution for injection Tenecteplase
Metalyse 8.000 enot prašek in vehikel za raztopino za injiciranje tenekteplaza
How to store Metalyse
Kako boste prejeli zdravilo Metalyse
Each vial contains 10,000 units (50 mg) tenecteplase.
Ena viala vsebuje 10.000 enot (50 mg) tenekteplaze.
Anaphylactoid reaction (including rash, urticaria, bronchospasm, laryngeal oedema)
Bolezni imunskega sistema redki anafilaktoidna reakcija (vključno z izpuščajem, urtikarijo, bronhospazmom, otekanjem grla)
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 2-8°C.
Normalno čas hrambe ni daljši od 24 ur, temperatura pa ne višja od 2 do 8 °C.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Metalyse 8,000 U
IME ZDRAVILA IN POT(I) UPORABE Vehikel za Metalyse 8.000 enot Vehikel za parenteralno uporabo
NAME OF THE MEDICINAL PRODUCT Metalyse 8,000 units powder and solvent for solution for injection
IME ZDRAVILA Metalyse 8.000 enot prašek in vehikel za raztopino za injiciranje
How to storeMetalyse
Shranjevanje zdravilaMetalyse
However, the analysis of data from more than 12,000 patients treated during phase I, II and III did not reveal any clinically relevant interactions with medicinal products commonly used in patients with AMI and concomitantly used with tenecteplase.
in III. faze ni odkrila klinično pomembnih medsebojnih učinkov z zdravili, ki jih običajno dajemo bolnikom z akutnim miokardnim infarktom, kadar so jih prejemali sočasno s tenekteplazo.
1 vial of powder for solution for injection with 40 mg tenecteplase 1 pre-filled syringe with 8 ml of solvent for parenteral use
FARMACEVTSKA OBLIKA IN VSEBINA 1 viala praška za raztopino za injiciranje s 40 mg tenekteplaze 1 napolnjena injekcijska brizga z 8 ml vehikla za parenteralno uporabo
Metalyse 10,000 units powder and solvent for solution for injection Tenecteplase
Metalyse 10.000 enot prašek in vehikel za raztopino za injiciranje tenekteplaza
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Metalyse 10,000 U
IME ZDRAVILA IN POT(I) UPORABE Vehikel za Metalyse 10.000 enot Vehikel za parenteralno uporabo
Patency data from the phase I and II angiographic studies suggest that tenecteplase, administered as a single intravenous bolus, is effective in dissolving blood clots in the infarct-related artery of subjects experiencing an AMI on a dose related basis.
faze kažejo, da tenekteplaza v enkratnem intravenskem bolusu pri bolnikih z akutnim miokardnim infarktom učinkovito in od velikosti odmerka odvisno raztaplja krvne strdke v arteriji, ki jo je prizadel infarkt.
Alternatively the reconstitution can be performed with the included needle.
Za pripravo raztopine lahko uporabite tudi priloženo iglo.
Each pre-filled syringe contains 8 ml solvent.
Ena napolnjena injekcijska brizga vsebuje 8 ml vehikla.
Known haemorrhagic diathesis
• znana hemoragična diateza,
NAME OF THE MEDICINAL PRODUCT Metalyse 10,000 units powder and solvent for solution for injection
IME ZDRAVILA Metalyse 10.000 enot prašek in vehikel za raztopino za injiciranje
10 ml plastic pre-filled syringe with 8 ml of solvent.
Napolnjena plastična brizga po 10 ml, ki vsebuje 8 ml vehikla.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL FOR SOLVENT
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Each pre-filled syringe contains 10 ml solvent.
Ena napolnjena injekcijska brizga vsebuje 10 ml vehikla.
Metalyse is given by a single injection into a vein by a doctor who is experienced in the use of this type of medicinal product.
Zdravnik, ki ima s tovrstnimi zdravili izkušnje, vam bo zdravilo Metalyse vbrizgal z eno injekcijo v veno.
When reconstituted with 10 ml solvent each ml contains 1,000 U tenecteplase.
1 ml raztopine, pripravljene z 10 ml vehikla, vsebuje 1000 enot tenekteplaze.
When reconstituted with 8 ml solvent each ml contains 1,000 U tenecteplase.
1 ml raztopine, pripravljene z 8 ml vehikla, vsebuje 1000 enot tenekteplaze.
10 ml plastic pre-filled syringe with 10 ml of solvent.
Napolnjena plastična brizga po 10 ml, ki vsebuje 10 ml vehikla.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10,000 units (50 mg) tenecteplase.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 10.000 enot (50 mg) tenekteplaze.
Pulmonary haemorrhage
redki krvavitev v osrčnik
Remove the tip-cap from the syringe.
Snamemo zaščito s konice brizge.
internal bleeding in the abdomen (retroperitoneal bleeding) bleeding in the brain (cerebral haemorrhage).
motnjo krvavitve ali nagnjenost h krvavitvam (hemoragiji), kap (zaplet na možganskem žilju),
No local irritation of the blood vessel was observed after intravenous, intra-arterial or paravenous administration of the final formulation of tenecteplase.
Po intravenskem, intraarterijskem in paravenskem dajanju končnega pripravka tenekteplaze niso zasledili lokalnega dražečega učinka na žile.
No formal interaction studies with tenecteplase and medicinal products commonly administered in patients with AMI have been performed.
S tenekteplazo in zdravili, ki jih običajno dajemo bolnikom z akutnim miokardnim infarktom, niso izvedli uradnih študije medsebojnega delovanja.
Reconstitute by swirling gently.
Raztopino pripravimo z rahlim vrtenjem viale in brizge
Remove the flip-off cap from the vial.
Brizgo snamemo z nastavka za vialo.
How isMetalyse administered
Kako bosteprejeli zdravilo Metalyse
Rare(may affect up to 1 in 1,000 people): low blood pressure (hypotension) bleeding in the lungs (pulmonary haemorrhage) hypersensitivity (anaphylactoid reactions) e.g.rash, hives (urticaria), difficulty breathing (bronchospasm) bleeding into the area surrounding the heart (haemopericardium) blood clot in the lung (pulmonary embolism) and in the vessels of other organ systems (thrombotic embolisation)
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): srčni zastoj, težave s srčno zaklopko ali osrčnikom (inkompetenca mitralne zaklopke, perikardialna efuzija), krvni strdek v venah (venska tromboza), tekočina med osrčnikom in srcem (srčna tamponada), pretrganje srčne mišice (ruptura miokarda).
Adjunctive therapy
Dodatno zdravljenje
Disconnect syringe from the vialadapter.
NALEPKA NA BRIZGI ZA VEHIKEL
Embolism (thrombotic embolisation) Respiratory, thoracic and mediastinal disorders Common
Žilne bolezni zelo pogosti krvavitev redki embolija (trombotična embolija) Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti epistaksa redki pljučna krvavitev
Date of first authorisation: 23 September 2009 Date of latest renewal: 14 May 2014
Datum prve odobritve: 23. september 2009 Datum zadnjega podaljšanja: 14. maj 2014
An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period)should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Priložnostna uporaba acetilsalicilne kisline (ne več kot 1000 mg v kateremkoli 24-urnem obdobju) na splošno ne bi smelo povzročati težav, vendar pa se morate o daljši uporabi v drugih okoliščinah posvetovati s svojim zdravnikom.
Some other medicines may influence the use of Clopidogrel Krka or vice versa.
Nekatera druga zdravila lahko vplivajo na jemanje zdravila Klopidogrel Krka in obratno.