FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee was of the opinion that the concomitant use of atazanavir and other anti-HIV medicines should not be contraindicated, but that a warning should be added in section 4.4.
Slovenian: Odbor je menil, da sočasna uporaba atazanavirja in drugih zdravil proti virusu HIV ne sme biti kontraindicirana, vendar da je treba dodati opozorilo v poglavje 4.4.
English: Protium is used to treat diseases where the stomach produces too much acid.
Slovenian: Zdravilo Protium se uporablja za zdravljenje bolezni, pri katerih želodec proizvaja preveč kisline.
English: This has led to divergences among Member States in the way the medicine can be used, as seen in the differences in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Slovenian: To je v različnih državah članicah privedlo do razhajanj glede uporabe zdravila, kakor je razvidno iz razlik med povzetki glavnih značilnosti zdravila, označevanjem in navodili za uporabo v državah, kjer se zdravilo trži.
English: The European Medicines Agency has completed a review of Protium and associated names.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Protium in povezanih imen.
English: The dose can be adjusted depending on the amount of acid being secreted in the stomach.
Slovenian: Odmerek je mogoče prilagoditi glede na količino kisline, ki se izloča v želodcu.
English: The CHMP agreed on a harmonised indication (the disease for which the medicine may be used).
Slovenian: CHMP je potrdil usklajeno indikacijo (bolezen, pri kateri se zdravilo lahko uporablja).
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Slovenian: Deluje tako, da zavira „protonske črpalke“ - beljakovine, ki so v specializiranih celicah v želodčni sluznici in črpajo kislino v želodec.
English: By blocking the pumps, pantoprazole reduces acid production.
Slovenian: Pantoprazol z zaviranjem črpalk zmanjša nastajanje kisline.
English: The CHMP harmonised the SPC sections on pregnancy and lactation, the ability to drive and use machines, undesirable effects and overdose.
Slovenian: CHMP je uskladil poglavja povzetka glavnih značilnosti zdravil glede nosečnosti in dojenja, sposobnosti vožnje in upravljanja s stroji, neželenih učinkov in prevelikega odmerjanja.
English: This can be increased to 40 mg a day in cases where symptoms of reflux oesophagitis relapse.
Slovenian: Odmerek je mogoče povečati na 40 mg dnevno, če se simptomi refluksnega ezofagitisa ponovijo.
English: The CHMP noted that, due to interactions, the concomitant use of PPIs may affect the efficacy of atazanavir and other HIV medications whose absorption is pH-dependent.
Slovenian: CHMP je ugotovil, da lahko zaradi medsebojnega delovanja sočasna uporaba zaviralcev protonske črpalke vpliva na učinkovitost atazanavirja in drugih zdravil proti virusu HIV, katerih absorpcija je odvisna od vrednosti pH.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Protium and associated names in the European Union (EU) and the European Economic Area (EEA).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) in Evropskem gospodarskem prostoru (EGP) uskladiti podatke o predpisovanju zdravila Protium in povezanih imen.
English: • reflux disease to treat symptoms such as heartburn and acid regurgitation (acid flowing up in the mouth),
Slovenian: • refluksna bolezen - za zdravljenje simptomov, kot so zgaga in regurgitacija kisline (vračanje želodčne kisline v usta),
English: Protium is also available in the EU and EEA under other trade names: Anagastra, Apton, Controloc, Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20, Panto-Byk-40, Panto-Byk-IV, Pantoc,
Slovenian: Zdravilo Protium je v EU in EGP na voljo tudi pod drugimi tržnimi imeni: Anagastra, Apton, Controloc, Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20, Panto-Byk-40, Panto-Byk-IV, Pantoc, Pantoloc, PantoLomberg, Pantopan, Pantoprazol 20 mg Byk, Pantoprazol NYC, Pantoprazol Nycomed, Pantoprazol-Byk, Pantoprazole ALTANA, Pantoprazole Lomberg, Pantorc, Pantozol, Peptazol, Rifun, Somac, Ulcotenal, Zurcal, Zurcale in Zurcazol.
English: The 40 mg gastroresistant tablets can also be used to eradicate Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers.
Slovenian: 40 mg gastrorezistentne tablete se lahko uporabljajo tudi za eradikacijo bakterije Helicobacter pylori (H. pylori) v kombinaciji z ustreznim antibiotičnim zdravljenjem pri bolnikih z razjedami, ki jih povzroča H. pylori.
English: Protium can also be used for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment, and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcers.
Slovenian: Zdravilo Protium se lahko uporablja tudi za preprečevanje želodčnih razjed, ki jih lahko povzročajo nekatera zdravila za zdravljenje bolečin in vnetij, imenovana neselektivna nesteroidna protivnetna zdravila, kadar bolnik potrebuje neprekinjeno zdravljenje z nesteroidnimi protivnetnimi zdravili, in za pomoč pri odstranitvi bakterije Helicobacter pylori, ki povzroča razjede na želodcu, iz želodca.
English: The CHMP also included a warning that treatment with Protium and other PPIs may lead to an increase in infections of the gut.
Slovenian: CHMP je dodal tudi opozorilo, da lahko zdravljenje z zdravilom Protium in drugimi zaviralci protonske črpalke okrepi okužbe črevesja.
English: The active substance in Protium, pantoprazole, is a proton pump inhibitor (PPI).
Slovenian: Zdravilna učinkovina zdravila Protium, pantoprazol, je zaviralec protonske črpalke.
English: To eradicate H. pylori in the stomach, the recommended dose is one 40 mg gastro-resistant tablet taken twice a day in combination with appropriate antibiotic treatment.
Slovenian: Za eradikacijo bakterije H. pylori v želodcu je priporočeni odmerek ena 40 mg gastrorezistentna tableta dvakrat dnevno v kombinaciji z ustreznim antibiotičnim zdravljenjem.
English: Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions are treated with a daily dose of 80 mg of pantoprazole, either as two 40 mg tablets or an injection.
Slovenian: Zollinger-Ellisonov sindrom in druga stanja s patološko povečanim izločanjem želodčne kisline se zdravijo z dnevnim odmerkom 80 mg pantoprazola v obliki dveh 40 mg tablet ali injekcije.
English: The Committee recommended that the 40 mg gastro-resistant tablets and the 40 mg powder for solution for injection should be used to treat reflux oesophagitis, gastric and duodenal ulcer, and Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
Slovenian: Odbor je priporočil, da se 40 mg gastrorezistentne tablete in 40 mg prašek za raztopino za injiciranje uporabljajo za zdravljenje refluksnega ezofagitisa, razjed na želodcu in dvanajstniku, ZollingerEllisonovega sindroma ter drugih stanj s patološko povečanim izločanjem želodčne kisline.
English: The recommended dosage for the treatment of symptomatic gastro-oesophageal reflux disease, the long-term management of reflux oesophagitis and the prevention of gastroduodenal ulcers in patients taking NSAIDs, the recommended dose is one 20 mg tablet once daily.
Slovenian: Priporočeni odmerek pri zdravljenju simptomatske gastroezofagealne refluksne bolezni, dolgoročnem spremljanju refluksnega ezofagitisa in preprečevanju razjed na želodcu in dvanajstniku pri bolnikih, zdravljenih z neselektivnimi nesteroidnimi protivnetnimi zdravili, je ena 20 mg tableta enkrat dnevno.
English: • stomach or duodenal ulcer,
Slovenian: • razjeda na želodcu ali dvanajstniku,
English: The Committee recommended that the 20 mg gastro-resistant tablets should be used for the treatment of symptomatic gastro-oesophageal reflux disease, the long-term management and prevention of relapse in reflux oesophagitis and the prevention of gastroduodenal ulcers induced by non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment.
Slovenian: Odbor je priporočil, da se 20 mg gastrorezistentne tablete uporabljajo za zdravljenje simptomatske gastroezofagealne refluksne bolezni, dolgoročno spremljanje in preprečevanje ponovitve refluksnega ezofagitisa ter za preprečevanje razjed na želodcu in dvanajstniku zaradi neselektivnih nesteroidnih protivnetnih zdravil pri bolnikih s tveganjem, pri katerih je potrebno neprekinjeno zdravljenje z neselektivnimi nesteroidnimi protivnetnimi zdravili.
English: The amended information to doctors and patients is available here The European Commission issued a decision on 15 April 2010.
Slovenian: Evropska komisija je odločbo izdala dne 15. aprila 2010.
English: The recommended dose for reflux oesophagitis and gastric or duodenal ulcers is one 40 mg tablet or one 40 mg injection daily.
Slovenian: Priporočeni odmerek pri refluksnem ezofagitisu ter pri razjedah na želodcu ali dvanajstniku je ena 40-miligramska tableta ali ena 40-miligramska injekcija dnevno.
English: On 3 September 2008, the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Protium and associated names in the EU and the EEA.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Protium in povezanimi imeni v EU in EGP, je dne 3. septembra 2008 zadevo napotila na Odbor za zdravila za uporabo v humani medicini (CHMP).
English: Protium has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Protium potrebno usklajevanje.
English: Co-administration of atazanavir with PPIs is not recommended.
Slovenian: Sočasna uporaba atazanavirja in zaviralcev protonske črpalke ni priporočljiva.
English: Questions and answers on the referral for Protium and associated names pantoprazole, 20 or 40 mg gastro-resistant tablets and 40 mg powder for solution for injection
Slovenian: pantoprazol, 20 ali 40 mg gastrorezistentne tablete in 40 mg prašek za raztopino za injiciranje
English: Recommendations for the safe handling:
Slovenian: Priporočila za varno ravnanje:
English: Unopened vial 12 months.
Slovenian: Neodprta viala 12 mesecev
English: Package Leaflet: Information for the user
Slovenian: Navodilo za uporabo: Informacije za uporabnika
English: The expiry date refers to the last day of that month.
Slovenian: Datum izteka roka uporabnosti se izteče na zadnji dan navedenega meseca.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 January 2012
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum pridobitve dovoljenja za promet: 31. januar 2012
English: Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Slovenian: Zdravnik bo izračunal vašo telesno površino v kvadratnih metrih (m²) in določil odmerek, ki ga morate dobiti.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portal o zdravilih.
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali bolnišničnega farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: • hair loss (in most cases normal hair growth should return)
Slovenian: • izguba las in dlak (večinoma se obnovi njihova normalna rast)
English: Ask your doctor for advice before being given any medicine.
Slovenian: Posvetujte se s svojim zdravnikom, preden vzamete katerokoli zdravilo.
English: If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued.
Slovenian: Če bolnik tudi pri odmerku 60 mg/m² še doživlja te reakcije, je treba zdravljenje prekiniti.
English: 117 allée des parcs 69800 Saint Priest France
Slovenian: 117 allée des parcs 69800 Saint Priest Francija
English: 117 allée des Parcs F-69 800 Saint Priest France
Slovenian: 117 allée des Parcs F-69 800 Saint Priest Francija
English: - if you have a severe liver disease.
Slovenian: - če imate hudo bolezen jeter.
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Mylan.
Slovenian: Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na zdravilo Docetaxel Mylan.
English: If crystals appear, the solution must no longer be used and shall be discarded.
Slovenian: Če se pojavijo kristali, se raztopine ne sme več uporabiti in jo je potrebno zavreči.
English: As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction.
Slovenian: Zato je med sočasnim zdravljenjem s temi zdravili potrebna previdnost, saj obstaja možnost izrazitega medsebojnega delovanja.
English: The amount of alcohol in this medicinal product may alter the effects of other medicines.
Slovenian: Vsebnost alkohola v zdravilu lahko spremeni učinke drugih zdravil.
English: • decrease in blood pressure; irregular or rapid heart beat
Slovenian: • znižanje krvnega tlaka; nereden ali hiter srčni utrip
English: In about 20% of these cases there were no risk factors for acute renal failure concomitant nephrotoxic medicinal products and gastro-intestinal disorders.
Slovenian: V približno 20 % teh primerov ni bilo nobenih dejavnikov tveganja za akutno ledvično odpoved, sočasnih nefrotoksičnih zdravil in bolezni prebavil.
English: All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Slovenian: Vse materiale, uporabljene pri redčenju in dajanju zdravila, je treba odstraniti skladno s standardnimi postopki.
English: Pharmacotherapeutic group: antineoplastic agents, taxanes, ATC Code: L01CD02
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, taksani, oznaka ATC: L01CD02
English: Before each treatment with Docetaxel Mylan, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Mylan.
Slovenian: Pred vsako uporabo zdravila Docetaxel Mylan boste opravili preiskave krvi za preverjanje ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite zdravilo Docetaxel Mylan.
English: Mylan - if the number of white blood cells is too low.
Slovenian: - če imate premajhno število belih krvnih celic.
English: Between infusions of Docetaxel Mylan the following may occur, and the frequency may vary with the combinations of medicines that are received.
Slovenian: Med infuzijami zdravila Docetaxel Mylan se lahko pojavi naslednje in pogostnost se lahko razlikuje glede na kombinacijo zdravil, ki so uporabljena:
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznake ''Uporabno do''.
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m² is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Slovenian: Zavedati se je treba, da je to verjetno podcenjen delež, kajti znano je, da docetaksel sam v odmerku 100 mg/m² povzroči nevtropenijo pri 97 % bolnikov, 76 % stopnje 4, na podlagi najnižjega števila celic v krvi.
English: During the infusion at the hospital the following allergic reactions (may affect more than 1 in 10 people):
Slovenian: Med infundiranjem v bolnišnici se lahko pojavijo naslednje alergijske reakcije (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Docetaxel Mylan will be given by infusion into one of your veins (intravenous use).
Slovenian: Zdravilo Docetaxel Mylan boste dobili v infuziji v eno od ven (intravenska uporaba).
English: This is because Docetaxel Mylan or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Slovenian: Bodisi zdravilo Docetaxel Mylan bodisi drugo zdravilo namreč mogoče ne bo delovalo tako dobro, kot bi bilo pričakovati, in verjetneje je, da se bo pri vas pojavil kakšen neželen učinek.
English: Withdraw the required amount of this docetaxel concentrate (20 mg/ml) from the vial and add it directly into the infusion solution.
Slovenian: Odvzemite potrebno količino tega koncentrata docetaksela (20 mg/ml) iz viale in ga dodajte neposredno v raztopino za infundiranje.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: Hazard ratio (TAC/FAC)
Slovenian: TAC FAC Razmerje ogroženosti (TAC/FAC)
English: One patient in TAC arm died because of dilated cardiomyopathy.
Slovenian: Ena bolnica v kraku TAC je umrla zaradi dilatativne kardiomiopatije.
English: Each box contains 1 or 5 vials.
Slovenian: Škatla vsebuje 1 vialo ali 5 vial.
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed in the primary analysis (at the median follow-up time of 77 months) (see table below):
Slovenian: Podskupine bolnic, zdravljenih s TAC, so analizirali po prospektivno opredeljenih prognostičnih dejavnikih v primarni analizi (po mediano 77 mesecih spremljanja) (glejte spodnjo preglednico):
English: See also section “Docetaxel Mylan contains ethanol” below.
Slovenian: Glejte tudi poglavje “Zdravilo Docetaxel Mylan vsebuje etanol” spodaj.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 25
English: Other medicines and Docetaxel Mylan
Slovenian: Druga zdravila in zdravilo Docetaxel Mylan
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Mylan concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Docetaxel Mylan 20 mg/1 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Slovenian: Podatki o reverzibilnosti so na voljo za 35,3 % bolnikov, pri katerih so se po zdravljenju z docetakselom kot monoterapijo v odmerku 100 mg/m² pojavili nevrotoksični učinki.
English: Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4)
Slovenian: Nevtropenija (4.stopnje) Febrilna nevtropenija Nevropenična okužba Nevropenična okužba (3.-4. stopnja)
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanje raztopljenega zdravila glejte poglavje 6.3.
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Docetaxel Mylan may be harmful for the unborn baby.
Slovenian: Med zdravljenjem z zdravilom Docetaxel Mylan ne smete zanositi in morate uporabljati učinkovito kontracepcijsko zaščito, ker lahko zdravilo Docetaxel Mylan škoduje vašemu nerojenemu otroku.
English: Hazard ratio*
Slovenian: razmerje tveganj*
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na poseben recept in le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Slovenian: To shemo so uporabljali 4 cikluse vsake 3 tedne, če so po 2 ciklusih opazili vsaj majhen odziv (≥ 25 % zmanjšanje dvodimenzionalno merjene velikosti tumorja).
English: One hundred eighty six patients were randomized to receive docetaxel (100 mg/m²) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Slovenian: Stošestinosemdeset (186) bolnic je bilo randomiziranih na prejemanje docetaksela (100 mg/m²) s trastuzumabom ali brez njega; 60 % bolnic je prej dobilo adjuvantno kemoterapijo na osnovi antraciklinov.
English: *a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC.
Slovenian: *Razmerje tveganj manj kot 1 pomeni, da je TAC povezan z daljšim preživetjem brez bolezni in daljšim celotnim preživetjem kot FAC.
English: The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/mm
Slovenian: Najpogosteje opisani neželeni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; srednji čas do najmanjšega števila je bil 7 dni, srednje trajanje hude nevtropenije (< 500 celic/mm
English: Docetaxel Mylan will be administered to you by a healthcare professional.
Slovenian: Zdravilo Docetaxel Mylan vam bo dal pristojni zdravstveni delavec.
English: Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility
Slovenian: Neželeni učinki na moda, opisani v študijah toksičnosti na glodalcih, nakazujejo, da lahko docetaksel prizadene moško plodnost.
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Slovenian: ŠTEVILKA SERIJE<, ENOTNE OZNAKE DAROVANJA IN IZDELKOV> Številka serije:
English: In the case of severe neutropenia (< 500 cells/mm for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
Slovenian: Če se med zdravljenjem z docetakselom pojavi huda nevtropenija (< 500 celic/mm sedem dni ali več), je med naslednjimi ciklusi priporočljivo zmanjšati odmerek ali uporabiti ustrezne simptomatske ukrepe (glejte poglavje 4.2).
English: More than one vial may be necessary to obtain the required dose for the patient.
Slovenian: Za zahtevan odmerek za bolnika je lahko potrebna več kot ena viala.
English: The most commonly reported adverse reactions of Docetaxel Mylan alone are: decrease in the number of red blood cells or white blood cells, hair loss, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Slovenian: Najpogosteje poročani neželeni učinki zdravila Docetaxel Mylan samega so: zmanjšanje števila rdečih ali belih krvnih celic, izguba las, siljenje na bruhanje, bruhanje, razjede v ustih, driska in utrujenost.