FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6 % for clopidogrel plus ASA, and 6.3 % for placebo plus ASA.
Slovenian: Pri bolnikih, ki so ostali na zdravljenju do 5 dni pred koronarno premostitveno operacijo, je bil delež dogodkov 9,6 % za klopidogrel in ASA in 6,3 % za placebo in ASA.
English: In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month postACS.
Slovenian: Nasprotno pa so post hoc analize pokazale, da je z močnejšimi zaviralci P2Y12 statistično značilno večje tveganje za krvavitve; krvavitve se pojavijo pretežno med fazo vzdrževalnega zdravljenja, po prvem mesecu po AKS.
English: - a planned surgery (including dental) in the next seven days
Slovenian: - nedavna huda poškodba - nedaven kirurški poseg (vključno na zobeh) - načrtovan kirurški poseg (vključno na zobeh) v naslednjih 7 dneh
English: While you are taking Grepid:
Slovenian: Ko jemljete zdravilo Grepid:
English: Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese
Slovenian: Serumska bolezen, anafilaktoidne reakcije, navzkrižna preobčutljivost med tienopiridini (kot sta tiklopidin in prasugrel) (glejte poglavje 4.4)*, avtoimuni inzulinski sindrom, ki lahko vodi v resno hipoglikemijo, še posebej pri bolnikih s HLA DRA4 podtipom (pogostejši v japonski populaciji)*
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC code: B01AC04.
Slovenian: Farmakoterapevtska skupina: Antitrombotiki, zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC04.
English: Follow-up at one year was performed for 316 patients (98.1 %) in the de-escalated DAPT group and 318 patients (98.5 %) in the unchanged DAPT group.
Slovenian: Enoletno spremljanje je bilo opravljeno pri 316 bolnikih (98,1 %) v skupini z deeskaliranim DAPT in pri 318 bolnikih (98,5 %) v skupini z nespremenjenim DAPT.
English: Medicinal products that are strong or moderate CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz.
Slovenian: Med zdravila, ki so močni ali zmerni zaviralci CYP2C19, spadajo, na primer; omeprazol in esomeprazol, fluvoksamin, fluoksetin, moklobemid, vorikonazol, flukonazol, tiklopidin, , karbamazepin, efavirenz.
English: In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR =4.0%; CI: -22.5 to 11.7 [p=0.639]).
Slovenian: Pri bolnikih, ki so bili vključeni v preskušanje samo na podlagi nedavnega miokardnega infarkta, je bil klopidogrel numerično inferioren, vendar se statistično ni razlikoval od ASA (zmanjšanje RT= -4,0 %; IZ: -22,5 do 11,7 [p=0,639]).
English: Grepid contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Slovenian: Zdravilo Grepid vsebuje klopidogrel in spada v skupino zdravil, ki se imenujejo zaviralci agregacije trombocitov.
English: The cumulative incidence of all bleeding events (BARC class 1 to 5) was 9 % (114 events) in the guided de-escalation group versus 11 % (137 events) in the control group (p=0.14).
Slovenian: Kumulativna pojavnost vseh krvavitev (razredi od 1 do 5 po BARC) je bila 9 % (114 dogodkov) v skupini z vodeno deeskalacijo in 11 % (137 dogodkov) v kontrolni skupini (p = 0,14).
English: If you forget to take a dose of Grepid, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Slovenian: Če pozabite vzeti odmerek zdravila Grepid in se nanj spomnite do 12 ur po ustaljenem času, takoj vzemite tableto in nato vzemite naslednjo tableto spet ob ustaljenem času jemanja.
English: The clinical benefit provided by the more potent P2Y12 inhibitors, ticagrelor and prasugrel, in their pivotal studies is related to a significant reduction in recurrent ischaemic events (including acute and subacute stent thrombosis (ST), myocardial infarction (MI) and urgent revascularization).
Slovenian: Klinična korist močnejših zaviralcev P2Y12, tikagrelorja in prasugrela, v njunih ključnih študijah je bila povezana z značilnim zmanjšanjem ponovnih ishemičnih dogodkov (vključno z akutno in subakutno trombozo žilne opornice (ST - stent thrombosis), miokardnim infarktom (MI) in nujno revaskularizacijo).
English: - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections - carbamazepine, a medicine to treat some forms of epilepsy - moclobemide, medicine to treat depression - repaglinide, medicine to treat diabetes - paclitaxel, medicine to treat cancer - anti-retroviral medicines (medicines to treat HIV infections).
Slovenian: - karbamazepin, zdravilo za zdravljenje nekaterih oblik epilepsije, - moklobemid, zdravila za zdravljenje depresije, - repaglinid, zdravilo za zdravljenje sladkorne bolezni, - paklitaksel, zdravilo za zdravljenje raka, - protiretrovirusna zdravila (zdravila za zdravljenje okužbe z virusom HIV).
English: Grepid film-coated tablets are pink, round and biconvex.
Slovenian: Zdravilo Grepid filmsko obložene tablete so rožnate barve, okrogle in bikonveksne oblike.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Grepid (4 tablets of 75 mg) once at the start of treatment.
Slovenian: Če ste imeli hudo bolečino v prsih (nestabilna angina pektoris ali srčna kap), vam lahko zdravnik na začetku zdravljenja da enkrat 300 mg zdravila Grepid (štiri 75-mg tablete).
English: Grepid is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack or death).
Slovenian: Zdravilo Grepid jemljejo odrasli za preprečevanje nastanka krvnih strdkov (trombov) v otrdelih krvnih žilah (arterijah), proces je znan kot aterotromboza in lahko vodi do aterotrombotičnih dogodkov (kot so kap, srčni napad ali smrt).
English: The primary endpoint was the occurrence of the composite of an occluded infarct-related artery on the predischarge angiogram, or death or recurrent MI before coronary angiography.
Slovenian: Primarni opazovani dogodki so bili navzočnost zamašene arterije) (povezane z infarktom) na angiogramu pred odpustom ali smrt ali ponovni miokardni infarkt pred koronarno angiografijo.
English: Bleeding events defined as all BARC occurred in 30 patients (9.3 %) in the de-escalated DAPT group and in 76 patients (23.5 %) in the unchanged DAPT group (p<0.01).
Slovenian: Krvavitve, opredeljene kot vsi BARC, so se pojavile pri 30 bolnikih (9,3 %) v skupini z deeskaliranim DAPT in pri 76 bolnikih (23,5 %) v skupini z nespremenjenim DAPT (p < 0,01).
English: As a precautionary measure, breast-feeding should not be continued during treatment with Grepid.
Slovenian: Iz varnostnih razlogov naj se z dojenjem med zdravljenjem z zdravilom Grepid ne nadaljuje.
English: This statistically significant difference was mainly driven by fewer bleeding events, with no difference reported in ischaemic endpoints (p=0.36), while BARC ≥ 2 bleeding occurred less frequently in the de-escalated DAPT group (4.0 %) versus 14.9 % in the unchanged DAPT group (p<0.01).
Slovenian: Ta statistično značilna razlika je bil predvsem posledica manjšega števila krvavitev, medtem ko razlik v ishemičnih opazovanih dogodkih ni bilo (p = 0,36); krvavitve BARC ≥ 2 so bile manj pogoste v skupini z deeskaliranim DAPT (4,0 %) kot v skupini z nespremenjenim DAPT (14,9 %) (p < 0,01).
English: NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Slovenian: Nesteroidna protivnetna zdravila (NSAID - Non-Steroidal Anti-Inflammatory Drugs): v klinični študiji, izvedeni pri zdravih prostovoljcih, je sočasna uporaba klopidogrela in naproksena povečala okultno izgubo krvi iz prebavil.
English: What Grepid looks like and contents of the pack
Slovenian: Izgled zdravila Grepid in vsebina pakiranja
English: The primary outcome, a composite of cardiovascular death, stroke, urgent revascularization and BARC (Bleeding Academic Research Consortium) bleeding ≥ 2 at 1 year post-ACS, occurred in 43 patients (13.4 %) in the de-escalated DAPT group and in 85 patients (26.3 %) in the unchanged DAPT group (p<0.01).
Slovenian: Primarni izid, sestavljeni dogodek srčno-žilne smrti, možganske kapi, nujne revaskularizacije in krvavitve ≥ 2 po BARC (Bleeding Academic Research Consortium), se je 1 leto po AKS pojavil pri 43 bolnikih (13,4 %) v skupini z deeskaliranim DAPT in pri 85 bolnikih (26,3 %) v skupini z nespremenjenim DAPT (p < 0,01).
English: The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking clopidogrel 75 mg/day.
Slovenian: Odmerek 0,2 mg/kg je dosegel povprečno 49,3 % zavrtje (agregacija trombocitov povzročena s 5 µM ADP), primerljivo kot pri odraslih ob uporabi zdravila Grepid v odmerku 75 mg/dan.
English: Pink, round, biconvex, film-coated tablets.
Slovenian: filmsko obložena tableta Rožnate, okrogle, bikonveksne fimsko obložene tablete.
English: The guided de-escalation did not result in an increased combined risk of ischemic events (2.5 % in the deescalation group vs 3.2 % in the control group; p non-inferiority=0.0115), nor in the key secondary endpoint of BARC bleeding ≥ 2 ((5 %) in the de-escalation group versus 6 % in the control group (p=0.23)).
Slovenian: Vodena deeskalacija ni povečala ne kombiniranega tveganja za ishemične dogodke (2,5 % v skupini z deeskalacijo in 3,2 % v kontrolni skupini, p za neinferiornost = 0,0115) ne ključnega sekundarnega opazovanega dogodka, krvavitve ≥ 2 po BARC (5 % v skupini z deeskalacijo in 6 % v kontrolni skupini, p = 0,23).
English: The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section
Slovenian: Koristnosti zdravljenja s kombinacijo klopidrogela in ASA, ki bi bilo daljše od štirih tednov, v tem okviru niso preučevali (glejte poglavje 5.1).
English: Film-coating Hypromellose (E464) Iron oxide red (E172) Lactose monohydrate Triacetin (E1518) Titanium dioxide (E171)
Slovenian: Obloga tablete: hipromeloza (E464), rdeči železov oksid (E172), laktoza monohidrat, triacetin (E1518), titanov dioksid (E171).
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Grepid 75 mg film-coated tablets
Slovenian: Grepid 75 mg filmsko obložene tablete
English: You should specially tell your doctor if you take: - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscles or joints o heparin or any other injectable medicine used to reduce blood clotting o ticlopidine, other antiplatelet agent o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression - omeprazole or esomeprazole, medicines to treat upset stomach - fluconazole or voriconazole, medicines to treat fungal infections
Slovenian: Še posebej pomembno je, da obvestite svojega zdravnika, če jemljete - zdravila, ki lahko povečajo tveganje za krvavitve, kot so: o peroralni antikoagulanti, zdravila, ki preprečujejo nastanek krvnih strdkov, o nesteroidna protivnetna zdravila, ki se običajno uporabljajo za lajšanje bolečine in/ali vnetja mišic ali sklepov, o heparin, ali katerokoli drugo zdravilo v obliki injekcij, ki se uporablja za zmanjševanje strjevanja krvi, o tiklopidin, peroralno antiagregacijsko zdravilo, o selektivni zaviralci privzema serotonina (na primer fluoksetin ali fluvoksamin, a ne le tadva), ki se po navadi uporabljajo za zdravljenje depresije,
English: They are supplied in PVC/PE/PVDC/Alu blisters or in PA/ALL/PVC-Alu blisters packed in cartons containing 10, 14, 28, 30, 50, 84, 90 or 100 film-coated tablets.
Slovenian: Na voljo so v PVC/PE/PVDC/alu pretisnih omotih ali PA/ALL/PVC-alu pretisnih omotih, pakiranih v škatlah, ki vsebujejo 10, 14, 28, 30, 50, 84, 90 ali 100 filmsko obloženih tablet.
English: • if you have a risk of bleeding, such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
Slovenian: • če imate tveganje za krvavitev, kot je: - zdravstveno stanje s tveganjem za notranjo krvavitev (kot je rana na želodcu) - krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v tkivih, organih ali sklepih vašega telesa).
English: Ninety five patients (7 %) in the guided de-escalation group and 118 patients (9 %) in the control group (p non-inferiority=0.0004) had an event.
Slovenian: - Enega od dogodkov je imelo 95 bolnikov (7 %) v skupini z vodeno deeskalacijo in 118 bolnikov (9 %) v kontrolni skupini (p za neinferiornost = 0,0004).
English: How to take Grepid
Slovenian: Kako jemati zdravilo Grepid
English: Therefore, the guided de-escalation arm had patients on either prasugrel (40 %) or clopidogrel (60 %).
Slovenian: Zato so bili v skupini z vodeno deeskalacijo tako prejemniki prasugrela (40 %) kot prejemniki klopidogrela (60 %).
English: Grepid 75 mg film-coated tablets clopidogrel
Slovenian: Grepid 75 mg filmsko obložene tablete klopidogrel
English: Very rare, not known* (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Slovenian: Zelo redki, neznani* Systemic Symptoms), eritematozen ali eksfoliativen izpuščaj, urtikarija, ekcem, lihen planus
English: Rare side effects (may affect up to 1 in 1,000 people): Vertigo, enlarged breasts in males.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): Vrtoglavica, povečanje prsi pri moških.
English: 15351 Pallini Attiki Greece
Slovenian: 15351 Pallini Attiki Grčija ali
English: Grepid contains lactose.
Slovenian: Zdravilo Grepid vsebuje laktozo.
English: Do not take Grepid
Slovenian: Ne jemljite zdravila Grepid:
English: No special storage conditions (for all aluminium blisters)
Slovenian: Za shranjevanje zdravila niso potrebna posebna navodila (za aluminijaste pretisne omote).
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, druginduced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms
Slovenian: Bulozen dermatitis (toksična epidermalna nekroliza, StevensJohnsonov sindrom, multiformni eritem, akutna generalizirana eksantemska pustuloza (AGEP)), angioedem, z zdravili povzročen sindrom preobčutljivosti (sindrom DIHS, DrugInduced
English: • Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Slovenian: • odraslih bolnikih z miokardnim infarktom (od nekaj dni do manj kot 35 dni), ishemično kapjo
English: Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Slovenian: Če ste vzeli večji odmerek zdravila Grepid, kot bi smeli Zaradi povečanega tveganja krvavitve se posvetujte s svojim zdravnikom ali oddelkom najbližje bolnišnične nujne zdravniške pomoči.
English: Store below 25°C (for PVC/PE/PVDC/aluminium blisters) Or
Slovenian: Shranjujte pri temperaturi do 25°C (za PVC/PE/PVDC/alu pretisne omote).
English: • Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Slovenian: Okvara ledvic Terapevtske izkušnje pri bolnikih z okvaro ledvic so omejene (glejte poglavje 4.4).
English: ST segment elevation acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300-mg loading dose in combination with ASA and with or without thrombolytics.
Slovenian: Akutni miokardni infarkt z elevacijo ST spojnice: klopidogrel je potrebno dajati v enkratnem dnevnem odmerku 75 mg, zdravljenje pa je potrebno začeti s 300 mg udarnim odmerkom v kombinaciji z ASA ter z/brez uporabe trombolitikov.
English: - The other ingredients are (see section 2 ‘Grepid contains lactose'): Tablet core: Microcrystalline cellulose, hydroxypropylcellulose (E463), mannitol (E421), crospovidone (type A), citric acid monohydrate, macrogol 6000, stearic acid, talc Tablet coating: Hypromellose (E464), iron oxide red (E172), lactose monohydrate, triacetin (E1518), titanium dioxide (E171)
Slovenian: - Druge sestavine so (glejte poglavje 2: »Zdravilo Grepid vsebuje laktozo«): Jedro tablete: mikrokristalna celuloza, hidroksipropilceluloza (E463), manitol (E421), krospovidon (vrsta A), citronska kislina monohidrat, makrogol 6000, stearinska kislina, smukec.
English: - The active substance is clopidogrel.
Slovenian: - Zdravilna učinkovina je klopidogrel.
English: Packs of 10, 14, 28, 30, 50, 84, 90 or 100 film-coated tablets.
Slovenian: Pakiranja po 10, 14, 28, 30, 50, 84, 90 ali 100 filmsko obloženih tablet.
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see ‘Warnings and precautions').
Slovenian: Vendar pa se morate takoj posvetovati s svojim zdravnikom, če ste glede krvavitve v kakršnihkoli dvomih (glejte poglavje 2 »Opozorila in previdnostni ukrepi«).
English: Marketing Authorisation Holder Pharmathen S.A., 6 Dervenakion
Slovenian: Pharmathen S.A., 6 Dervenakion
English: − Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300-mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA)
Slovenian: Akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca):zdravljenje moramo začeti z enkratnim udarnim odmerkom 300 mg klopidogrela in nadaljevati s 75 mg enkrat na dan (s 75 mg do 325 mg acetilsalicilne kisline (ASA) dnevno).
English: Patients were randomized to receive either prasugrel 5 or 10 mg/d (Days 0-14) (n=1,309), or prasugrel 5 or 10 mg/d (Days 0-7) then de-escalated to clopidogrel 75 mg/d (Days 8-14) (n=1,309), in combination with ASA (<100 mg/day).
Slovenian: Bolnike so randomizirali bodisi na prejemanje prasugrela 5 ali 10 mg/dan (od 0. do 14. dne) (n = 1309) bodisi na prejemanje prasugrela 5 ali 10 mg/dan (od 0. do 7. dne) s poznejšim deeskaliranjem na 75 mg klopidogrela na dan (od 8. do 14. dne) (n = 1309) v kombinaciji z ASA (< 100 mg/dan).
English: Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Slovenian: Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki klopidogrelijevega besilata).
English: If Grepid is supplied in PVC/PE/PVDC/aluminium blisters, store below 25°C.
Slovenian: Zdravilo Grepid, ki je na voljo v PVC/PE/PVDC/alu pretisnih omotih, shranjujte pri temperaturi do 25°C.
English: What Grepid contains
Slovenian: Kaj vsebuje zdravilo Grepid
English: BLISTER/ 10, 14, 28, 30, 50, 84, 90 or 100 film-coated tablets
Slovenian: PRETISNI OMOT / 10, 14, 28, 30, 50, 84, 90 ali 100 filmsko obloženih tablet
English: Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Slovenian: Povprečna največja koncentracija nespremenjenega klopidogrela v plazmi (približno 2,2-2,5 ng/ml po enem 75-mg peroralnem odmerku) se je pojavila približno 45 minut po odmerjanju.Absorpcija je najmanj 50 %, na podlagi metabolitov klopidrogela, izločenih z urinom.
English: If Grepid is supplied in all aluminium blisters, it does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila v aluminijastih pretisnih omotih niso potrebna posebna navodila.
English: Pharmathen S.A., 6 Dervenakion 15351 Pallini Attiki Greece
Slovenian: Pharmathen S.A. 6 Dervenakion 15351 Pallini Attiki Grčija
English: Glenmark Pharmaceuticals B.V. Tel: +31 (0)20 561 6127
Slovenian: Tel: +31 (0)20 561 6127
English: How to store Grepid
Slovenian: Shranjevanje zdravila Grepid
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON for blisters of 10, 14, 28, 30, 50, 84, 90 or 100 film-coated tablets
Slovenian: Kartonska škatla za pretisne omote s 10, 14, 28, 30, 50, 84, 90 ali 100 filmsko obloženimi tabletami
English: Cellulose, microcrystalline Hydroxypropylcellulose (E463) Mannitol (E421) Crospovidone (type A) Citric acid monohydrate Macrogol 6000
Slovenian: 6.1 Seznam pomožnih snovi jedro tablete mikrokristalna celuloza hidroksipropilceluloza (E463) manitol (E421) krospovidon (vrsta A) citronska kislina monohidrat makrogol 6000 stearinska kislina smukec filmska obloga hipromeloza (E464) rdeči železov oksid (E172) laktoza monohidrat triacetin (E1518) titanov dioksid (E171)
English: SSRIs: since SSRIs affect platelet activation and increase the risk of bleeding, the concomitant administration of SSRIs with clopidogrel should be undertaken with caution.
Slovenian: Selektivni zaviralci privzema serotonina (SSRI - Selective serotonin re-uptake inhibitors): Selektivni zaviralci privzema serotonina vplivajo na aktivacijo trombocitov in povečajo nevarnost krvavitve, zato je ob sočasnem jemanju selektivnih zaviralcev privzema serotonina in klopidogrela potrebna previdnost.
English: - If you have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Slovenian: • se lahko krvavitev ustavi počasneje kot ponavadi, če se urežete ali poškodujete.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 28. julij 2009
English: Bleeding at puncture site
Slovenian: Krvavitve na mestu vboda
English: Vertigo
Slovenian: Hrvatska
English: 2 vials + 2 vials l t o r
Slovenian: 2 viale + 2 viale o č
English: Invented name Strength Pharmaceutical Form Route of Administration
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: This overview was last updated in 09-2019
Slovenian: Povzetek je bil nazadnje posodobljen 09-2019.
English: Lipegfilgrastim is a form of filgrastim, which has been available in the EU for a number of years.
Slovenian: Lipegfilgrastim je oblika filgrastima, ki je v EU na voljo že več let.
English: Further information on Lonquex can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/lonquex
Slovenian: Nadaljnje informacije o zdravilu Lonquex so na voljo na spletni strani agencije: www.ema.europa.eu/medicines/human/EPAR/lonquex
English: Patients may be able to inject the medicine themselves once they have been properly trained but the first injection should be under the direct supervision of a doctor.
Slovenian: Bolniki si lahko zdravilo injicirajo sami, potem ko so bili za to ustrezno usposobljeni, vendar mora biti prvo injiciranje opravljeno pod neposrednim nadzorom zdravnika.
English: The side effects of the medicine were typical for this class of medicines and are considered manageable.
Slovenian: Neželeni učinki zdravila so bili značilni za ta razred zdravil in veljajo za obvladljive.
English: For more information, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.