FrancophonIA/ELRC3.0 huggingface dataset:
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: V primeru pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: • Bleeding from anywhere in the body.
Slovenian: • Krvavitev iz katerega koli dela telesa.
English: Bleeding is the most likely pharmacological effect of overdose.
Slovenian: Krvavitev je najverjetnejši farmakološki učinek prevelikega odmerjanja.
English: Table 1 depicts adverse reactions that have been identified based upon a pooling of combined data from all CHAMPION studies.
Slovenian: V preglednici 1 so navedeni neželeni učinki, ugotovljeni na podlagi združevanja kombiniranih podatkov iz vseh študij CHAMPION.
English: Swirl gently until all material is dissolved.
Slovenian: Nežno obračajte tako dolgo, da se raztopi ves material.
English: Data from the CHAMPION pooled population of over 25,000 PCI patients provide additional clinical support for safety.
Slovenian: Podatki za združeno populacijo CHAMPION za več kot 25.000 bolnikov s PKI dodatno klinično podpirajo podatke o varnosti.
English: These effects were not apparent at lower doses and were reversible following cessation of dosing.
Slovenian: Ti učinki niso bili vidni pri nižjih odmerkih in so bili po prenehanju odmerjanja reverzibilni.
English: ** Transfusion was uncommon 101/12,565 (0.8%).
Slovenian: ** transfuzija je bila občasna 101/12.565 (0,8 %)
English: No dose adjustment is needed for these populations.
Slovenian: Pri teh populacijah ni treba prilagajati odmerka.
English: • You have been told by your doctor that you have an intolerance to some sugars.
Slovenian: • vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev.
English: - If you are allergic to cangrelor or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na kangrelor ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: very rare (<1/10,000).
Slovenian: <1/1.000); zelo redki (<1/10.000).
English: Cytochrome P450 (CYP)
Slovenian: Citokrom P450 (CYP)
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom,
English: The median duration of cangrelor infusion was 129 minutes.
Slovenian: Mediano trajanje infundiranja kangrelorja je bilo 129 minut.
English: Multiple related adverse reaction terms have been grouped together in the table and include medical terms as described below: a.
Slovenian: V preglednici je združenih več povezanih zadevnih izrazov, ki vključujejo medicinske pojme, kot je opisano zgoraj: a.
English: The doctor will decide how much Kengrexal you receive, and will prepare the medicine.
Slovenian: Vaš zdravnik se bo odločil, koliko zdravila Kengrexal boste prejeli, in pripravil zdravilo.
English: The dose given depends on your weight.
Slovenian: Uporabljeni odmerek je odvisen od vaše telesne mase.
English: Death/MI/IDR/ST
Slovenian: Smrt/MI/IDR/ST
English: • Minor bruising can occur anywhere in the body (including small red bruises on the skin or at the site of an injection under the skin causing swelling),
Slovenian: • manjše modrice se lahko pojavijo kjer koli po telesu (vključno z majhnimi rdečimi modricami na koži ali na mestu injiciranja pod kožo, ki povzročajo oteklino);
English: Risk of bleeding
Slovenian: Tveganje za krvavitve
English: No dose adjustment is needed in elderly (≥75 years) patients.
Slovenian: Pri starejših bolnikih (≥ 75 let) odmerka ni treba prilagajati.
English: Breast cancer resistance protein (BCRP)
Slovenian: Protein odpornosti pri raku dojke (BCRP-breast cancer resistance protein)
English: These included cases of anaphylactic reactions/shock and angioedema (see section 4.8).
Slovenian: To vključuje primere anafilaktičnih reakcij/šoka in angioedema (glejte poglavje 4.8).
English: • You have ever suffered from an allergic reaction to Kengrexal or any of its constituents.
Slovenian: • ste kadar koli imeli alergijsko reakcijo na zdravilo Kengrexal ali katero od njegovih sestavin.
English: 48155 Münster GERMANY
Slovenian: 48155 Münster
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se ne uporabi takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik.
English: Mild a
Slovenian: Blaga a
English: The safety and efficacy of cangrelor in children aged less than 18 years has not been established.
Slovenian: Varnost in učinkovitost kangrelorja pri otrocih, starih manj kot 18 let, nista bili dokazani.
English: At the discretion of the physician, the infusion may be continued for a total duration of four hours, see section 5.1.
Slovenian: Po presoji zdravnika se lahko infuzija nadaljuje, skupaj štiri ure, glejte poglavje 5.1.
English: • increased levels of creatinine in the blood (identified by blood tests), indicating reduced kidney function,
Slovenian: • povečana raven kreatinina v krvi (ugotovljena s krvnimi testi), kar kaže na zmanjšano delovanje ledvic;
English: • Allergic reaction (a rash, itching, throat tightening/swelling, swelling of the tongue or lips, difficulty breathing).
Slovenian: • Alergijska reakcija (izpuščaj, srbenje, zoženje/oteklost žrela, oteklost jezika ali ustnic, težave z dihanjem).
English: The bioavailability of cangrelor is complete and immediate.
Slovenian: Absorpcija Biološka uporabnost kangrelorja je popolna in takojšnja.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Kengrexal is not recommended for children and adolescents under 18 years.
Slovenian: Zdravilo Kengrexal se ne priporoča za otroke in mladostnike, stare manj kot 18 let.
English: Kengrexal is available in packs of 10 vials.
Slovenian: Zdravilo Kengrexal je na voljo v pakiranjih po 10 vial.
English: During this procedure you may have a stent inserted in your blood vessel to help to keep it open.
Slovenian: Med tem postopkom vam bodo morda v krvno žilo vstavili žilno opornico, ki bo žilo pomagala ohranjati odprto.
English: Mix the bag thoroughly.
Slovenian: Vrečo temeljito premešajte.
English: Fructose intolerance
Slovenian: Intoleranca za fruktozo
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: This medicinal product contains 52.2 mg sorbitol in each vial.
Slovenian: To zdravilo vsebuje 52,2 mg sorbitola v en viali.
English: If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine.
Slovenian: Če imate dedno intoleranco za fruktozo, redko genetsko bolezen, vi ne smete dobiti tega zdravila.
English: IDR a Primary endpoint from logistic regression adjusted for loading dose and patient status.
Slovenian: a Primarni opazovani dogodek z logistične regresije, prilagojen za začetni odmerek in status bolnika.
English: Your treatment with Kengrexal will be supervised by a doctor experienced in caring for patients with heart disease.
Slovenian: Vaše zdravljenje z zdravilom Kengrexal bo nadziral zdravnik z izkušnjami v oskrbi bolnikov z boleznijo srca.
English: Of the recovered material, 58% was found in urine and the remaining 35% was found in faeces, presumably following biliary excretion.
Slovenian: 58 % snovi so izmerili v urinu, preostalih 35 % pa v blatu, verjetno po izločanju skozi žolč.
English: If bleeding occurs appropriate supportive measures should be taken, which may include stopping the medicinal product so platelet function can return.
Slovenian: Če se pojavi krvavitev, je treba uvesti ustrezne podporne ukrepe, ki lahko vključujejo ukinitev uporabe zdravila, da se lahko povrne delovanje trombocitov.
English: Severe/life-threatening
Slovenian: Huda/življenjsko nevarna
English: The pharmacokinetic properties of cangrelor have been evaluated and found to be linear in patients and healthy volunteers.
Slovenian: Ocenili so farmakokinetične lastnosti kangrelorja in ugotovili, da so pri bolnikih in zdravih prostovoljcih linearne.
English: Possible implications for the in vivo situation have not been investigated, but caution is advised when cangrelor is to be combined with a BCRP substrate.
Slovenian: Možnih implikacij za situacijo in vivo niso preučili, vendar pa se pri kombiniranju kangrelorja s substratom BCRP priporoča previdnost.
English: Any unexplained fall in blood pressure or haematocrit should lead to the serious consideration of a haemorrhagic event and the cessation of cangrelor administration.
Slovenian: Vsak nepojasnjeni upad krvnega tlaka ali hematokrita mora biti povod za skrben razmislek o hemoragičnem dogodku in prekinitev dajanja kangrelorja.
English: p-values for secondary endpoints based on Chi-squared test.
Slovenian: Vrednosti p za sekundarne opazovane dogodke na podlagi testa hi-kvadrata.
English: Platelets are very small cells in the blood that can clump together and help the blood to clot.
Slovenian: Trombociti so zelo majhne celice v krvi, ki se zlepljajo in pomagajo pri strjevanju krvi.
English: • balloon-like swelling in an artery or wall of the heart, which involves only a few layers of the vessel walls,
Slovenian: • balonu podobno otekanje v arteriji ali steni srca, ki vključuje le nekaj slojev stene žil;
English: This dilution will generate a concentration of 200 micrograms/mL and should be sufficient for at least two hours of dosing as required.
Slovenian: S to razredčitvijo dobite koncentracijo 200 mikrogramov/ml, kar mora zadoščati za vsaj dveurno odmerjanje, kot je potrebno.
English: - If you have ever had a stroke, or a ‘mini-stroke' (also known as a transient ischaemic attack, TIA) caused by the temporary interruption of the blood supply to the brain.
Slovenian: - če ste kadar koli imeli »mini kap« (imenovana tudi tranzitorna ishemična ataka, TIA) zaradi začasne prekinitve oskrbe možganov s krvjo.
English: No baseline demographic factor altered the relative risk of bleeding with cangrelor.
Slovenian: Izhodiščni demografski dejavniki niso vplivali na relativno tveganje za krvavitev s kangrelorjem.
English: There is no antidote to Kengrexal, however, the pharmacokinetic half-life of Kengrexal is three to six minutes.
Slovenian: Antidota za zdravilo Kengrexal ni, vendar pa je farmakokinetični razpolovni čas zdravila Kengrexal tri do šest minut.
English: Transfusion and GUSTO severe/life-threatening bleeding rates were similar.
Slovenian: Pogotnosti transfuzij in hudih/življenjsko nevarnih krvavitev po lestvici GUSTO so bile podobne.
English: Anatomical changes correlated with increased plasma creatinine and urea, and increased albumin and blood cells in urine.
Slovenian: Anatomske spremembe so korelirale s povečanjem kreatinina in sečnine v plazmi ter povečanimi ravnmi albumina in krvnih celic v urinu.
English: • variations in blood pressure,
Slovenian: • spremembe krvnega tlaka;
English: Alternatively, a loading dose of ticagrelor or prasugrel, but not clopidogrel, may be administered up to 30 minutes before the end of the infusion, see section 4.5.
Slovenian: Alternativno se lahko uporabi polnilni odmerek tikagrelorja ali prasugrela, ne pa klopidogrela, do 30 minut pred koncem infuzije, glejte poglavje 4.5.
English: Powder in 10 mL glass vials (Type 1) closed with a Flurotec coated butyl rubber stopper and sealed with crimped aluminium seal.
Slovenian: Prašek v 10 ml steklenih vialah (tip 1), zaprt z zamaškom Flurotec iz butilne gume in zapečaten z aluminijasto zaporko.
English: Adverse reactions are classified according to frequency and system organ class.
Slovenian: Neželeni učinki so opredeljeni po pogostnosti in glede na organske sisteme.
English: Cangrelor has a volume of distribution of 3.9 L. Cangrelor is 97-98% plasma-protein bound.
Slovenian: Volumen porazdelitve kangrelorja je 3,9 l. Kangrelor se veže na beljakovine v plazmi 97-98 %.
English: • Active bleeding or increased risk of bleeding, because of impaired haemostasis and/or irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension.
Slovenian: • Aktivna krvavitev ali večje tveganje za krvavitev zaradi okvare hemostaze in/ali ireverzibilne motnje koagulacije ali zaradi nedavne velike operacije/poškodbe ali neobvladane hude hipertenzije.
English: Instructions for preparation
Slovenian: Navodilo za pripravo
English: It is unknown whether Kengrexal is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Kengrexal izloča v materino mleko.
English: Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary.
Slovenian: Bolniki z dedno intoleranco za fruktozo ne smejo prejeti tega zdravila, razen če je nujno potrebno.
English: If you use more Kengrexal than you should
Slovenian: Če ste uporabili večji odmerek zdravila Kengrexal, kot bi smeli
English: Patients 100 kg and over will require a minimum of two bags.
Slovenian: Bolniki s telesno maso 100 kg ali več potrebujejo vsaj dve vreči.
English: What Kengrexal is and what it is used for
Slovenian: Kaj je zdravilo Kengrexal in za kaj ga uporabljamo
English: Sometimes clots can form within a damaged blood vessel such as in an artery in the heart and this can be very dangerous as the clot can cut off the blood supply (a thrombotic event), causing a heart attack (myocardial infarction).
Slovenian: Včasih lahko v poškodovanih krvnih žilah, kot so arterije v srcu, nastajajo strdki, kar je lahko zelo nevarno, saj lahko strdek prekine oskrbo s krvjo (trombotični dogodek), kar povzroči srčno kap (miokardni infarkt).
English: The other ingredients are mannitol, sorbitol and sodium hydroxide for pH-adjustment.
Slovenian: Druge sestavine zdravila so manitol, sorbitol in natrijev hidroksid za uravnavanje pH.
English: Further analysis of GUSTO mild bleeding revealed that a large proportion of mild bleeding events were ecchymosis, oozing and <5 cm haematoma.
Slovenian: Nadaljnja analiza blagih krvavitev po lestvici GUSTO je pokazala, da so bili velik delež blagih dogodkov s krvavitvijo ekhimoza, izcejanje in < 5 cm hematom.
English: Acetylsalicylic acid, heparin, nitrogycerin
Slovenian: Acetilsalicilna kislina, heparin, nitroglicerin
English: - If you have any further questions, ask your doctor.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom.
English: Coagulation time abnormal, prothrombin time prolonged.
Slovenian: nenormalen čas koagulacije, podaljšan protrombinski čas d.
English: If you have any further questions on the use of this medicine, ask your doctor.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom.
English: Administration of 600 mg clopidogrel immediately after the cessation of the cangrelor infusion results in the anticipated full pharmacodynamic effect.
Slovenian: Dajanje 600 mg klopidogrela takoj po prenehanju infundiranja kangrelorja je povzročil pričakovani polni farmakodinamični učinek.
English: Reconstitute each 50 mg/vial by adding 5 mL of sterile water for injection.
Slovenian: Rekonstituirajte vsakih 50 mg/vialo z dodajanjem 5 ml sterilne vode za injekcije.
English: Following the intravenous administration of a 2 micrograms/kg/min infusion of [3H] cangrelor to healthy male volunteers, 93% of total radioactivity was recovered.
Slovenian: Po intravenskem dajanju infuzije 2 mikrogramov/kg/min [3H] kangrelorja zdravim moškim prostovoljcem so izmerili 93 % skupne radioaktivnosti.
English: Although most bleeding associated with the use of cangrelor occurs at the site of arterial puncture, haemorrhage can occur at any site.
Slovenian: Čeprav se je večina krvavitev, povezanih z uporabo kangrelorja, pojavila na mestu vboda v arterijo, se lahko krvavitev pojavi na katerem koli mestu.
English: Tell your doctor if you are taking other medicines that may increase the risk of side effects such as bleeding including blood thinners (anticoagulants e.g. warfarin).
Slovenian: Zdravniku povejte, če jemljete druga zdravila, ki lahko povečajo nevarnost neželenih učinkov, kot je krvavitev, vključno z zdravili za redčenje krvi (antiloagulanti, npr. varfarin).
English: • bleeding leading to decreases in blood volume or red blood cell numbers,
Slovenian: • krvavitev, ki povzroči zmanjšanje volumna krvi ali števila rdečih krvnih celic;
English: Patients can be transitioned from cangrelor to ticagrelor without interruption of antiplatelet effect.
Slovenian: Bolniki lahko s kangrelorja na tikagrelor preidejo brez prekinitve protitrombotičnega učinka.
English: The effect of Kengrexal wears off quickly and it is unlikely to affect your ability to drive or to use machines.
Slovenian: Učinki zdravila Kengrexal hitro izzvenijo in ni verjetno, da bi vplivali na vašo sposobnost vožnje ali uporabe strojev.
English: Patients with HFI cannot break down fructose, which may cause serious side effects.
Slovenian: Bolniki z dedno intoleranco za fruktozo ne morejo razgraditi fruktoze, kar lahko povzroči resne neželene učinke.
English: OR = odds ratio; CI = confidence interval; IDR = ischaemia-driven revascularisation; MI = myocardial infarction; mITT = modified intent-to-treat; ST = stent thrombosis.
Slovenian: IZ = interval zaupanja; IDR = revaskularizacija zaradi ishemije (ischaemia-driven revascularisation); MI = miokardni infarkt; mITT = prilagojena populacija z namenom zdravljenja (modified intent-totreat); ST = tromboza stenta (stent thrombosis).
English: You have been prescribed Kengrexal because you have blocked blood vessels in your heart (coronary artery disease) and you need a procedure (called a percutaneous coronary intervention - PCI) to remove the blockage.
Slovenian: Zdravilo Kengrexal so vam predpisali, ker imate v srcu neprehodne krvne žile (bolezen koronarnih arterij) in potrebujete postopek (imenovan perkutana koronarna intervencija - PCI) za odstranitev ovire.
English: Kengrexal should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures and is intended for specialised use in an acute and hospital setting.
Slovenian: Zdravilo Kengrexal mora dati zdravnik z izkušnjami z akutno koronarno oskrbo ali intervencijskimi koronarnimi postopki in je namenjeno za specializirano uporabo v akutnih okoliščinah in v bolnišnici.
English: Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC25.
Slovenian: Farmakoterapevtska skupina: zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC25.
English: Excipient with known effect Each vial contains 52.2 mg sorbitol.
Slovenian: Pomožna snov z znanim učinkom Ena viala vsebuje 52,2 mg sorbitola.
English: In vitro inhibition of BCRP by the metabolite ARC-69712XX at clinically relevant concentrations has been observed.
Slovenian: In vitro so opazili, da presnovek ARC-69712XX v klinično pomembnih koncentracijah zavira BCRP.
English: Any GUSTO bleeding
Slovenian: Katera koli krvavitev GUSTO
English: In addition, a higher rate of GUSTO moderate bleeding was reported in the cangrelor group (6.7%) compared to clopidogrel (1.4%).
Slovenian: Poleg tega so poročali o višji stopnji zmerne krvavitve GUSTO v skupini s kangrelorjem (6,7 %) v primerjavi s klopidogrelom (1,4 %).
English: Allergic reaction is a rare side effect of treatment with Kengrexal (may affect up to 1 in 1,000 people) but may be potentially serious.
Slovenian: Alergijska reakcija je redek neželeni učinek zdravljenja z zdravilom Kengrexal (pojavi se lahko pri največ 1 od 1.000 bolnikov), a je lahko resna.
English: Kengrexal contains sodium and sorbitol
Slovenian: Zdravilo Kengrexal vsebuje natrij in sorbitol
English: In clinical trials, the maximum accidental overdose was 10 times (bolus) or 3.5 times the infusion dose normally administered and bleeding was the most frequently observed adverse event.
Slovenian: V kliničnih preskušanjih je bil največji nenamerni preveliki odmerek desetkrat (bolus) ali 3,5-krat večji od običajno infundiranega odmerka, krvavitev pa je bila najpogostejši opaženi neželeni učinek.
English: - If you have a medical condition that is currently causing bleeding such as bleeding from the stomach or intestines or you have a condition which makes you more prone to uncontrolled bleeding (impaired haemostasis or irreversible coagulation disorders).
Slovenian: - če imate bolezen, ki vam trenutno povzroča krvavitev, kot je krvavitev v želodcu ali črevesju, ali če imate stanje, zaradi katerega ste bolj nagnjeni k nenadzorovani krvavitvi (okvarjena hemostaza ali nereverzibilna motnja koagulacije).
English: Female fertility was not affected at any dose.
Slovenian: Sposobnost razmnoževanja pri samicah ni bila prizadeta ob nobenem odmerku.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Slovenian: Kategorije pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do
English: b In CHAMPION PHOENIX, GUSTO Mild was defined as other bleeding requiring intervention but not requiring blood transfusion or causing haemodynamic compromise.
Slovenian: b V analizi CHAMPION PHOENIX je bil blagi dogodek GUSTO opredeljen kot druga krvavitev, zaradi katere je bil potreben ukrep, vendar ni bila potrebna transfuzija krvi, in ki ni ogrozila hemodinamike.
English: The half-life of Kengrexal is three to six minutes, independent of dose.
Slovenian: Izločanje Razpolovni čas zdravila Kengrexal je tri do šest minut, neodvisno od odmerka.
English: Cangrelor should be used with caution in these patients.
Slovenian: Pri teh bolnikih je treba kangrelor uporabljati previdno.
English: Cangrelor is deactivated rapidly in the plasma by dephosphorylation to form its primary metabolite, a nucleoside.
Slovenian: Kangrelor se v plazmi hitro deaktivira z defosforilacijo v svoj primarni presnovek, nukleozid.
English: Before administration, 5 mL reconstituted solution has to be withdrawn from each vial and must be diluted further with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection or glucose (5%) solution for injection.
Slovenian: Pred dajanjem iz vsake viale izvlecite 5 ml rekonstituirane raztopine in nadalje razredčite z 250 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje ali raztopino glukoze (5 %) za injiciranje.
English: What you need to know before you use Kengrexal Do not use Kengrexal
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Kengrexal Ne uporabljajte zdravila Kengrexal
English: For instructions on reconstitution and dilution of the medicinal product before administration see section 6.6.
Slovenian: Za navodila glede rekonstitucije in redčenja zdravila pred dajanjem glejte poglavje 6.6.
English: Contents of the pack and other information What Kengrexal contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Kengrexal
English: Cangrelor binds selectively and reversibly to the P2Y12 receptor to prevent further signalling and platelet activation.
Slovenian: Kangrelor se selektivno in reverzibilno veže na receptor P2Y12, da prepreči nadaljnjo signalizacijo in aktivacijo trombocitov.
English: For storage conditions after reconstitution and dilution of the medicinal product see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji in redčenju zdravila glejte poglavje 6.3.
English: Paediatric population Cangrelor has not been evaluated in a paediatric population (see sections 4.2 and 5.1).
Slovenian: Kangrelorja niso ocenili pri pediatrični populaciji (glejte poglavji 4.2 in 5.1).