FrancophonIA/ELRC3.0 huggingface dataset:
English: Does this refusal affect patients in clinical trials or compassionate use programmes?
Slovenian: Ali ta zavrnitev vpliva na bolnike v kliničnih preskušanjih ali programih sočutne uporabe?
English: What is Vanflyta and what was it intended to be used for?
Slovenian: Kaj je zdravilo Vanflyta in za kaj naj bi se uporabljalo?
English: How does Vanflyta work?
Slovenian: Kako zdravilo Vanflyta deluje?
English: It works by blocking FLT3, a protein involved in cell growth and proliferation.
Slovenian: Deluje z zaviranjem FLT3, beljakovine, ki sodeluje pri celični rasti in proliferaciji.
English: Refusal of the marketing authorisation for Vanflyta (quizartinib) EMA/559309/2019
Slovenian: Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Vanflyta (kvizartinib) EMA/559309/2019
English: Although the results from the main study indicated a marginal improvement in overall survival for patients given Vanflyta, the study had important limitations which meant that the effectiveness of Vanflyta could not be sufficiently demonstrated.
Slovenian: Čeprav rezultati glavne študije kažejo rahlo izboljšanje celokupnega preživetja pri bolnikih, ki so prejemali zdravilo Vanflyta, je imela študija večje omejitve, kar pomeni, da učinkovitosti zdravila Vanflyta ni bilo mogoče zadostno dokazati.
English: The company presented the results of a study in 367 patients with FLT3-ITD positive AML whose disease did not respond to treatment or came back after treatment.
Slovenian: Podjetje je predložilo rezultate študije s 367 bolniki s FLT3-ITD pozitivno akutno mieloično levkemijo, pri katerih se bolezen ni odzvala na predhodno zdravljenje ali se je po zdravljenju ponovila.
English: Therefore, the Agency's opinion was that the benefits of Vanflyta did not outweigh its risks and it recommended refusing marketing authorisation.
Slovenian: Zato je agencija menila, da koristi zdravila Vanflyta ne odtehtajo z njim povezanih tveganj, in priporočila zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom.
English: Vanflyta contains the active substance quizartinib and was to be available as tablets.
Slovenian: Zdravilo Vanflyta vsebuje učinkovino kvizartinib in naj bi bilo na voljo v obliki tablet.
English: Vanflyta was to be used in adult patients whose disease had come back or did not respond to previous treatments and for continuation of treatment after the patient had undergone a haematopoietic stem cell transplant (HSCT, a transplant of cells that can develop into different types of blood cells).
Slovenian: Uporabljalo naj bi se pri odraslih bolnikih, pri katerih se je bolezen ponovila ali se ni odzvala na predhodno zdravljenje, ter za nadaljevanje zdravljenja pri bolnikih, ki so prestali transplantacijo krvotvornih matičnih celic (HSCT, presaditev celic, ki se lahko razvijejo v različne vrste krvnih celic).
English: cancer medicines and the main measure of effectiveness was overall survival (how long patients lived) after being given Vanflyta or the comparator medicines.
Slovenian: Vanflyta so primerjali z drugimi zdravili za zdravljenje raka, glavno merilo učinkovitosti pa je bilo celokupno preživetje (kako dolgo so bolniki živeli) po dajanju zdravila Vanflyta ali primerjalnih zdravil.
English: The active substance in Vanflyta, quizartinib, is a ‘receptor tyrosine kinase inhibitor'.
Slovenian: Učinkovina v zdravilu Vanflyta, kvizartinib, je „zaviralec tirozin-kinaze“.
English: Vanflyta was developed as a cancer medicine for the treatment of a type of AML called ‘FLT3-ITD positive' (when the cancer cells have a certain change in the gene for a protein called FLT3).
Slovenian: Zdravilo Vanflyta je bilo razvito kot zdravilo proti raku za zdravljenje vrste akutne mieloične levkemije, imenovane „FLT3-ITD pozitivna“ (rakave celice imajo določeno spremembo v genu za beljakovino, imenovano FLT3).
English: By blocking FLT3, quizartinib is expected to stop cancer cells from multiplying and thus slow down the progression of the disease.
Slovenian: Kvizartinib naj bi z zaviranjem FLT3 ustavil razmnoževanje rakavih celic in tako upočasnil napredovanje bolezni.
English: Refusal of the marketing authorisation for Vanflyta (quizartinib)
Slovenian: Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Vanflyta (kvizartinib)
English: The European Medicines Agency has recommended the refusal of the marketing authorisation for Vanflyta, a medicine intended for the treatment of adults with acute myeloid leukaemia (AML) (a cancer of the white blood cells).
Slovenian: Evropska agencija za zdravila je priporočila zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Vanflyta, namenjenim zdravljenju odraslih z akutno mieloično levkemijo (AML) (vrsto raka belih krvnih celic).
English: The company informed the Agency that there are no consequences for patients in clinical trials or in compassionate use programmes with Vanflyta.
Slovenian: Podjetje je obvestilo agencijo, da zavrnitev nima posledic za bolnike, ki so vključeni v klinična preskušanja ali programe sočutne uporabe zdravila Vanflyta.
English: Vanflyta was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 March 2009 for the treatment of AML.
Slovenian: Zdravilo Vanflyta je bilo 23. marca 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje akutne mieloične levkemije.
English: The most common side effect (affects 1 to 10 patients in 100) reported with clopidogrel is bleeding.
Slovenian: Najpogostejši neželeni učinek (pojavi se pri 1 do 10 od 100 bolnikov), o katerem so poročali s klopidogrelom, je krvavitev.
English: • Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg with or without food.
Slovenian: • Odrasli in starostniki Klopidogrel se mora dajati kot enkratni dnevni odmerek 75 mg, z ali brez hrane.
English: • Paediatric patients The safety and efficacy of clopidogrel in children and adolescents have not yet been
Slovenian: • Pediatrični bolniki Varnost in učinkovitost klopidogrela pri otrocih in mladostnikih še nista ugotovljeni.
English: Some other medicines may influence the use of Clopidogrel Sandoz or vice versa.
Slovenian: Nekatera druga zdravila lahko vplivajo na uporabo zdravila Klopidogrel Sandoz in obratno.
English: Children and adolescents Clopidogrel Sandoz is not intended for use in children or adolescents.
Slovenian: Otroci in mladostniki Zdravilo Klopidogrel Sandoz ni namenjeno za uporabo pri otrocih ali mladostnikih.
English: Detailed information is available on the European Medicines Agency website: http://www.ema.europa.eu/
Slovenian: Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila : http://www.ema.europa.eu/.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/547/001-007
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/547/001-007
English: Do not use Clopidogrel Sandoz if you notice any visible sign of damage of blister or film-coated tablets.
Slovenian: Ne uporabljajte zdravila Klopidogrel Sandoz, če ste opazili vidne znake poškodovanja pretisnega omota ali filmsko obloženih tablet.
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide can be safely co-administered with clopidogrel.
Slovenian: Podatki študije CAPRIE kažejo, da se lahko fenitoin in tolbutamid sočasno s klopidogrelom varno uporabljata.
English: If you stop taking Clopidogrel Sandoz Do not stop the treatment.
Slovenian: Če ste prenehali jemati zdravilo Klopidogrel Sandoz Ne prekinite zdravljenja.
English: The association between CYP2C19 genotype and clopidogrel treatment outcome was evaluated in 2 post hoc clinical trial analyses (substudies of CLARITY [n = 465] and TRITON-TIMI 38 [n = 1,477]) and 5 cohort studies (total n = 6,489).
Slovenian: Povezavo med genotipom CYP2C19 in izidom zdravljenja s klopidogrelom so ocenili v 2 post hoc analizah kliničnih preskušanj (podštudiji CLARITY [n = 465] in TRITON-TIMI 38 [n = 1.477]) ter 5 kohortnih študijah (celotni n = 6.489).
English: Other side effects reported with clopidogrel are: -Common side effects:
Slovenian: Drugi neželeni učinki, o katerih so poročali s klopidogrelom, so: - Pogosti neželeni učinki:
English: You should take Clopidogrel Sandoz for as long as your doctor continues to prescribe it.
Slovenian: Zdravilo Klopidogrel Sandoz morate jemati, vse dokler vam ga vaš zdravnik predpisuje.
English: The usual dose is one 75 mg tablet of Clopidogrel Sandoz per day to be taken orally with or without food, and at the same time each day.
Slovenian: Običajni odmerek je ena 75-mg tableta zdravila Klopidogrel Sandoz na dan, ki jo lahko vzamete s hrano ali brez nje; odmerek morate jemati vsak dan ob istem času.
English: Taking Clopidogrel Sandoz with food and drink Clopidogrel Sandoz may be taken with or without food.
Slovenian: Jemanje zdravila Klopidogrel Sandoz skupaj s hrano in pijačo Zdravilo Klopidogrel Sandoz lahko jemljete s hrano ali brez nje.
English: If you forget to take a dose of Clopidogrel Sandoz, but remember within 12 hours of your usual time, take your tablet straight away and then take your next tablet at the usual time.
Slovenian: Če ste pozabili vzeti zdravilo Klopidogrel Sandoz Če pozabite vzeti odmerek zdravila Klopidogrel Sandoz in se nanj spomnite do 12 ur po ustaljenem času, takoj vzemite tableto in nato vzemite naslednjo tableto spet ob ustaljenem času jemanja.
English: Clopidogrel has been evaluated for safety for 1 year or more.
Slovenian: 4.8 Neželeni učinki Varnost klopidogrela so vrednotili v obdobju 1 leta ali več.
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Sandoz.
Slovenian: Če menite, da se karkoli od navedenega nanaša na vas, ali če ste kakorkoli v dvomih, se posvetujte s svojim zdravnikom, preden boste vzeli Klopidogrel Sandoz.
English: Like all medicines, Clopidogrel Sandoz can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Klopidogrel Sandoz neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: If you experience prolonged bleeding when taking Clopidogrel Sandoz.
Slovenian: Če doživite podaljšanje krvavitve v času jemanja zdravila Klopidogrel Sandoz.
English: If you take more Clopidogrel Sandoz than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Slovenian: Če ste vzeli večji odmerek zdravila Klopidogrel Sandoz, kot bi smeli Zaradi povečanega tveganja krvavitve se posvetujte s svojim zdravnikom ali oddelkom najbližje bolnišnične nujne zdravniške pomoči.
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Sandoz.
Slovenian: Če ste noseči ali mislite, da ste noseči, morate o tem obvestiti svojega zdravnika ali farmacevta, preden vzamete zdravilo Klopidogrel Sandoz.
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: Alameda da Beloura Edifício 1, 2º andar - Escritório 15 P-2710-693 Sintra Tel: +351 21 0008781
Slovenian: Alameda da Beloura Edifício 1, 2º andar - Escritório 15 PT-2710-693 Sintra Tel: +351 21 0008781
English: If you become pregnant while taking Clopidogrel Sandoz, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Slovenian: Če med zdravljenjem z zdravilom Klopidogrel Sandoz zanosite, se takoj posvetujte s svojim zdravnikom, saj jemanje klopidogrela med nosečnostjo ni priporočljivo.
English: It is preferable not to use this product during pregnancy and breast-feeding.
Slovenian: Nosečnost in dojenje Priporočljivo je, da se tega zdravila v nosečnosti in med dojenjem ne uporablja.
English: 4.8 Undesirable effects
Slovenian: MOŽNI NEŽELENI UČINKI
English: Poor metabolism: CYP2C19*2/*2, *2/*3 or *3/*3
Slovenian: Slaba presnova: CYP2C19*2/*2, *2/*3 ali *3/*3
English: Reduced CYP2C19 metabolism in intermediate and poor metabolisers decreased the Cmax and AUC of the active metabolite by 30-50% following 300- or 600 - mg loading doses and 75 - mg maintenance doses.
Slovenian: Zmanjšana presnova s CYP2C19 pri srednjih in slabih presnavljalcih je po 300- ali 600-mg polnilnem odmerku in 75-mg vzdrževalnem odmerku zmanjšala Cmax in AUC aktivnega presnovka za 30 do 50 %.
English: Clopidogrel Sandoz is taken 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 Klopidogrel Sandoz se jemlje 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: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Take special care with Clopidogrel Sandoz').
Slovenian: Vendar pa se morate takoj posvetovati s svojim zdravnikom, če ste glede krvavitve v kakršnihkoli dvomih (glejte poglavje 2 »Bodite posebno pozorni pri jemanju zdravila Klopidogrel Sandoz«).
English: signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Take special care with Clopidogrel Sandoz').
Slovenian: To so lahko znaki redkega zmanjšanja števila določenih krvnih celic, - znaki jetrnih težav, kot je porumenelost kože in/ali oči (zlatenica), ki so lahko, ali pa ne, povezani s krvavitvijo, ki se pojavi pod kožo kot drobne rdeče pike, in/ali zmedenostjo (glejte poglavje 2 »Bodite posebno pozorni pri jemanju zdravila Klopidogrel Sandoz«).
English: WHAT CLOPIDOGREL SANDOZ IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO KLOPIDOGREL SANDOZ IN ZA KAJ GA UPORABLJAMO
English: Excipients Clopidogrel Sandoz contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Slovenian: Klopidogrel Sandoz vsebuje hidrogenirano ricinusovo olje, ki lahko razdraži želodec in povzroči drisko.
English: Important information about some of the ingredients of Clopidogrel Sandoz: Clopidogrel Sandoz contains hydrogenated castor oil which may cause stomach upset or diarrhoea.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Klopidogrel Sandoz Zdravilo Klopidogrel Sandoz vsebuje hidrogenirano ricinusovo olje, ki lahko povzroči želodčne motnje ali drisko.
English: While taking Clopidogrel Sandoz, consult your doctor about the breast-feeding of a baby.
Slovenian: Med jemanjem zdravila Klopidogrel Sandoz se o dojenju posvetujte z zdravnikom.
English: What Clopidogrel Sandoz looks like and contents of the pack
Slovenian: Izgled zdravila Klopidogrel Sandoz in vsebina pakiranja
English: Clopidogrel Sandoz contains the active ingredient Clopidogrel which belongs to a group of medicines called antiplatelet medicinal products.
Slovenian: Klopidogrel Sandoz vsebuje zdravilno učinkovino klopidogrel, ki spada v skupino zdravil, ki se imenujejo zaviralci agregacije trombocitov.
English: In CLARITY and one of the cohort studies (n = 765; Trenk),
Slovenian: V CLARITY in eni od kohortnih študij (n = 765; Trenk) se deleži kardiovaskularnih dogodkov po genotipu niso bistveno razlikovali.
English: Clopidogrel Sandoz 75 mg film-coated tablets are white to off-white, marbled, round and biconvex.
Slovenian: Klopidogrel Sandoz 75 mg tablete so bele do belkaste, marmorirane, okrogle, bikonveksne filmsko obložene tablete.
English: No conclusive data on the pharmacodynamic interaction of clopidogrel and other PPIs are available.
Slovenian: Zanesljivih podatkov o farmakodinamskem medsebojnem delovanju klopidogrela in drugih zaviralcev protonske črpalke ni.
English: Clopidogrel Sandoz is unlikely to affect your ability to drive or to use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Klopidogrel Sandoz vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
English: EU/1/09/547/001-007
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/547/001-007
English: Take special care with Clopidogrel Sandoz:
Slovenian: Bodite posebno pozorni pri jemanju zdravila Klopidogrel Sandoz:
English: Do not use Clopidogrel Sandoz after the expiry date which is stated on the carton and on the blister after EXP.
Slovenian: Zdravila Klopidogrel Sandoz ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu po oznaki EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Sandoz 75 mg film-coated tablets
Slovenian: IME ZDRAVILA Klopidogrel Sandoz 75 mg filmsko obložene tablete
English: You have a condition of hardening of arteries (also known as atherosclerosis), and You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease (disturbed blood flow in arms or legs caused by vascular
Slovenian: Zdravilo Klopidogrel Sandoz vam je predpisano za pomoč pri preprečevanju nastajanja krvnih strdkov in za zmanjšanje tveganja teh hudih dogodkov, ker: - imate stanje otrdelih arterij (znano tudi kot ateroskleroza), in - ste predhodno doživeli srčni napad, kap ali imeli stanje, ki je znano kot periferna arterijska bolezen (moten krvni pretok v rokah ali nogah, ki ga povzroči zapora žil)
English: Clopidogrel Sandoz 75 mg film-coated tablets Clopidogrel
Slovenian: Klopidogrel Sandoz 75 mg filmsko obložene tablete klopidogrel
English: Mean inhibition of platelet aggregation (IPA) with 5 μM ADP was diminished by 39% (24 hours) and 21% (Day 5) when clopidogrel and omeprazole were administered together.
Slovenian: Če sta bila klopidogrel in omeprazol uporabljena skupaj, se je povprečno zavrtje agregacije trombocitov (IPA) s 5 μM ADP zmanjšalo za 39 % (24 ur) oz. 21 % (5. dan).
English: Clopidogrel Sandoz 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Klopidogrel Sandoz 75 mg
English: The exposure to the active metabolite of clopidogrel was decreased by 45% (Day 1) and 40% (Day 5) when clopidogrel and omeprazole were administered together.
Slovenian: Če sta bila klopidogrel in omeprazol uporabljena skupaj, se je izpostavljenost aktivnemu presnovku klopidogrela zmanjšala za 45 % (1. dan) oz. 40 % (5. dan).
English: Extensive metabolism: CYP2C19*1/*1 Intermediate metabolism: CYP2C19*1/*2 or *1/*3
Slovenian: Srednja presnova: CYP2C19*1/*2 ali *1/*3
English: Do not take Clopidogrel Sandoz: • If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of
Slovenian: • če ste alergični na (preobčutljivza klopidogrel ali katerokoli sestavino zdravila
English: Thrombocytopenia, leucopenia,
Slovenian: Trombocitopenija, levkopenija, eozinofilija
English: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
Slovenian: Bolezni prebavil driska, bolečine v trebuhu, dispepsija dvanajstniku, gastritis, bruhanje, navzea, zaprtje, flatulenca
English: - cimetidine, medicine to treat upset stomach - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy - ticlopidine, other antiplatelet agent.
Slovenian: • karbamazepin ali oksakarbazepin, zdravila za zdravljenje nekaterih oblik epilepsije,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega besilata.
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Sandoz: 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) a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body) a recent serious injury a recent surgery (including dental) a planned surgery (including dental) in the next seven days if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
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: While you are taking Clopidogrel Sandoz:
Slovenian: Ne jemljite zdravila Klopidogrel Sandoz:
English: - heparin or any other medicine used to reduce blood clotting - a proton pump inhibitor (e.g, omeprazole) for upset stomach - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and
Slovenian: • flukonazol, vorikonazol, ciprofloksacin ali klorampfenikol, zdravila za zdravljenje bakterijskih in glivičnih okužb,
English: If you forget to take Clopidogrel Sandoz
Slovenian: Shranjevanje zdravila Klopidogrel Sandoz
English: Driving and using machines
Slovenian: NAVODILA ZA UPORABO
English: Film-coating:
Slovenian: Navodilo vsebuje:
English: • You should tell your doctor if a surgery (including dental) is planned.
Slovenian: Ko jemljete zdravilo Klopidogrel Sandoz: • morate povedati zdravniku, če imate predvideno kakšno operacijo (vključno z
English: CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: Imetnik dovoljenja za promet z zdravilom
English: Epistaxis
Slovenian: Presnova
English: The protocols, abstracts and final study reports shall be submitted in the format set out in Annex III of Commission Implementing Regulation (EC) No 520/2012.
Slovenian: Protokoli, povzetki in zaključna poročila o študiji bodo predloženi v obliki, kot je navedena v Prilogi III Izvedbene uredbe Komisije (EU) št. 520/2012.
English: Annex IV Conditions to the marketing authorisation
Slovenian: Priloga IV Pogoji dovoljenja za promet
English: The MAH shall conduct a non-interventional post-authorisation safety study (PASS) to evaluate the safety of Targocid in adults with Gram-positive infections who are exposed to the higher loading dose of 12mg/kg twice a day (24 mg/kg/day).
Slovenian: Študija o varnosti zdravila po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom bo izvedel neintervencijsko študijo o varnosti zdravila po pridobitvi dovoljenja za promet za oceno varnosti zdravila Targocid pri odraslih s po Gramu pozitivnimi okužbami, ki so izpostavljeni polnilnemu odmerku, višjemu od 12 mg/kg dvakrat na dan (24 mg/kg/dan).
English: The study protocol shall be entered in the EU electronic register of post-authorisation studies (EU PAS Register) before the start of data collection.
Slovenian: Protokol študije bo vnesen v elektronski register študij o varnosti zdravila po pridobitvi dovoljenja za promet v EU (register EU PAS) pred začetkom zbiranja podatkov.
English: The protocol of this non-interventional PASS shall be submitted within 2 months of the Commission Decision.
Slovenian: Protokol te neintervencijske študije o varnosti zdravila po pridobitvi dovoljenja za promet bo predložen v dveh mesecih po sklepu Komisije.
English: Risk management plan The MAH shall submit a RMP within 6 months of the Commission Decision.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo predložil načrt za obvladovanje tveganja v šestih mesecih po sklepu Komisije.
English: 22 August 2017
Slovenian: 22. avgust 2017
English: • A treatment cycle lasts 28 days.
Slovenian: • Ciklus zdravljenja traja 28 dni.
English: This is a long-term treatment, possibly lasting for months or years.
Slovenian: Gre za dolgotrajno zdravljenje, ki lahko traja več mesecev ali let.
English: You may take it with or without food.
Slovenian: Lahko ga jemljete skupaj s hrano ali brez nje.