FrancophonIA/ELRC3.0 huggingface dataset:
English: However, concerns were raised regarding the evidence of bioequivalence, considering the study conducted with the 1 mg tablet to be insufficient to provide evidence of bioequivalence for the higher strengths, as bioequivalence studies for substances with low solubility should be conducted at the highest strength according to the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), unless the active substance is highly soluble or if there are safety/tolerability reasons.
Slovenian: Vendar so bili v zvezi s študijo, opravljeno z 1-miligramsko tableto, izraženi pomisleki, da za večje jakosti ni dovolj dokazov o biološki enakovrednosti, saj bi bilo treba študije biološke enakovrednosti za slabo topne snovi opraviti pri največji jakosti, kot je to določeno v Smernicah Odbora za zdravila za uporabo v humani medicini (CHMP) o raziskavah biološke enakovrednosti („CHMP Guideline on the Investigation of Bioequivalence“, CPMP/EWP/QWP/1401/98 Rev. 1/Corr), razen če je zdravilna učinkovina dobro topna ali za to obstajajo varnostni/tolerančni razlogi.
English: The CHMP also reviewed the biopharmaceutical data and agreed that the proposed and the reference products have similar dissolution profiles, when comparing the 1 mg and the 4 mg strengths separately.
Slovenian: Proučil je tudi biofarmacevtske podatke in se strinjal, da imata predlagano in referenčno zdravilo podoben profil raztapljanja, kadar ločeno primerjamo 1-miligramsko in 4-miligramsko jakost.
English: With such a low rate of dissolution, the Applicant considered that even the 1 mg strength possesses enough sensitivity to detect formulation differences.
Slovenian: Menil je, da je ob tako nizki stopnji raztapljanja že 1-miligramska jakost dovolj občutljiva, da omogoča zaznavanje razlik v formulaciji.
English: The CHMP assessed the Applicant justifications and agreed that glimepiride is associated with a risk of hypoglycaemic reactions, in particular in healthy subjects, including at the lowest 1 mg dose.
Slovenian: Odbor CHMP se je po oceni predlagateljevih utemeljitev strinjal, da je glimepirid povezan s tveganjem hipoglikemičnih reakcij, še zlasti pri zdravih preskušancih, in sicer tudi pri najnižjem 1-miligramskem odmerku.
English: The Applicant also considered that the observed decrease in drug dissolution could be solely attributed to the inherent characteristics of glimepiride and not to formulation differences.
Slovenian: Hkrati je še menil, da je mogoče ugotovljeno manjše raztapljanje zdravilne učinkovine pripisati le temeljnim značilnostim glimepirida, ne pa razlikam v formulaciji.
English: The CHMP considered that a further bioequivalence study using the 4 mg dose is not anticipated to provide significantly better discriminatory power between the different formulations, given the biopharmaceutical features of this glimepiride formulation and that such a study would therefore be unnecessary and ethically unacceptable, given the risk of hypoglycaemia.
Slovenian: Odbor je menil, da nadaljnja študija biološke enakovrednosti s 4miligramskim odmerkom - ob upoštevanju biofarmacevtskih lastnosti te formulacije glimepiridaverjetno ne bi zagotovila bistveno boljše diskriminacijske moči med posameznimi formulacijami, zato bi bila taka študija nepotrebna, zaradi tveganja hipoglikemične reakcije pa bi bila tudi etično nesprejemljiva.
English: The Applicant subsequently explored the acceptability of conducting a study using the 1 mg tablet in order to waive studies using the higher strengths.
Slovenian: Zato je proučil dopustnost izvedbe študije z uporabo 1-miligramske tablete, da bi se tako izognil študijam z uporabo večjih jakosti.
English: The Applicant investigated the solubility of drug substance across the physiological pH range and confirmed the very low solubility of glimepiride.
Slovenian: Proučil je topnost zdravilne učinkovine v razponu fiziološkega pH in potrdil ugotovitev, da je glimepirid zelo slabo topen.
English: The CHMP therefore considered that the conducted fasting bioequivalence study using the 1 mg strength was acceptable and adequate to demonstrate bioequivalence between test and reference formulations, while ensuring the safety of the study subjects.
Slovenian: Zato je menil, da je bila izvedena študija biološke enakovrednosti z uporabo 1-miligramske jakosti na tešče sprejemljiva in primerna kot dokaz biološke enakovrednosti med testno in referenčno formulacijo, z njo pa je bila zagotovljena tudi varnost sodelujočih v študiji.
English: The CHMP also considered that the presented biopharmaceutical and pharmacokinetic data confirmed the adequate sensitivity of the bio-analytical method and further supported the acceptability of the requested biowaiver for the 2, 3 and 4 mg strengths.
Slovenian: Poleg tega je še menil, da predloženi biofarmacevtski in farmakokinetični podatki potrjujejo primerno občutljivost bioanalitične metode ter dodatno dokazujejo, da je zahtevano izvzetje iz obveznosti izvedbe študij biološke enakovrednosti za 2-, 3- in 4miligramsko jakost dopustno.
English: The CHMP assessed the open label, randomized, comparative bioavailability study of glimepiride 1 mg tablets under fasting conditions and the Applicant justifications for the design of the study.
Slovenian: Odbor CHMP je ocenil odprto klinično randomizirano primerjalno študijo biološke uporabnosti 1-miligramskih tablet glimepirida pri uporabi na tešče in utemeljitve predlagatelja v zvezi z zasnovo študije.
English: Having reviewed the available literature, the Applicant concluded that fasting studies involving glimepiride appeared to be associated with a considerable risk of hypoglycaemia, even with the 1 mg dose.
Slovenian: Ob pregledu dostopne literature je ugotovil, da je mogoče študije, ki so bile opravljene na tešče in so vključevale glimepirid, očitno povezati s precejšnjim tveganjem hipoglikemične reakcije, in sicer tudi pri uporabi 1-miligramskega odmerka.
English: The CHMP was therefore of the view that absorption is not dependent or limited by in vivo drug dissolution and that the low solubility of glimepiride does not prevent granting a biowaiver for the 2, 3 and 4 mg strengths.
Slovenian: Zato je menil, da absorpcija ni niti odvisna od raztapljanja zdravilne učinkovine in vivo niti ni zaradi tega omejena ter da je mogoče kljub slabi topnosti glimepirida odobriti izvzetje iz obveznosti izvedbe študij biološke enakovrednosti („biowaiver“) za 2-, 3- in 4-miligramsko jakost.
English: • the CHMP considered the requested biowaiver for the 2, 3 and 4 mg strengths to be acceptable,
Slovenian: • Prav tako je menil, da je zahtevano izvzetje iz obveznosti izvedbe študij biološke enakovrednosti za 2-, 3- in 4-miligramsko jakost dopustno,
English: The Applicant stated that it considered the ethical concerns linked to the risk of hypoglycaemia in healthy adults when designing the bioequivalence study.
Slovenian: Predlagatelj je navedel, da je ob zasnovi študije biološke enakovrednosti upošteval etične pomisleke v zvezi s tveganjem hipoglikemične reakcije pri zdravih odraslih osebah.
English: The CHMP was therefore of the view that differences between the different strengths with regard to the in vivo rate of drug release are very unlikely.
Slovenian: Zato po njegovem mnenju ni zelo verjetno, da bi razlike med posameznimi jakostmi vplivale na sproščanje zdravilne učinkovine in vivo.
English: The CHMP also considered the fact that the particle size of the active substance is controlled to be reassuring.
Slovenian: Menil je še, da k večji gotovosti pripomore tudi dejstvo, da je zagotovljen nadzor nad velikostjo delcev zdravilne učinkovine.
English: In conclusion, the CHMP was of the opinion that the exceptional conditions relating to safety referred to in the Guideline on the Investigation of Bioequivalence are applicable to this particular application, despite the recommendation that bio-equivalence studies should be performed with the highest strength for substances with low solubility.
Slovenian: Odbor CHMP je zato menil, da se v tem posebnem primeru kljub priporočilu, da je treba študije biološke enakovrednosti za slabo topne snovi opraviti pri največji jakosti, uporabljajo posebni pogoji v zvezi z varnostjo iz Smernic CHMP o raziskavah biološke enakovrednosti.
English: Packaging Content (concentration)
Slovenian: Farmacevtska oblika Pot uporabe Ovojnina Vsebina (koncentracija)
English: Package size l t o r
Slovenian: 3 mg/ml
English: Strength Pharmaceutical Form
Slovenian: Velikost pakiranja
English: Duration of immunity: six months.
Slovenian: Trajanje imunosti: šest mesecev.
English: ATCvet code: QI09AB03.
Slovenian: Oznaka ATC vet: QI09AB03.
English: Onset of immunity: three weeks after completion of the basic vaccination scheme.
Slovenian: Nastop imunosti: tri tedne po zaključku osnovne sheme cepljenja.
English: LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Gerona) SPAIN
Slovenian: LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Gerona) ŠPANIJA
English: Pigs from 6 months of age which have not been previously vaccinated with the product should be given two injections with an interval of 3-4 weeks.
Slovenian: Pri prašičih, starih 6 mesecev ali več, ki še niso bili cepljeni s tem zdravilom, je treba dati dve injekciji z razmikom 3-4 tednov.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC tabela 1 so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: Special warnings for each target species: Vaccinate only healthy animals.
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto: Cepite le zdrave živali.
English: For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Slovenian: Za aktivno imunizacijo prašičjih samcev in samic za zmanjšanje kliničnih znakov (kožnih lezij in vročice) svinjske rdečice, ki jo povzroča bakterija Erysipelothrix rhusiopathiae, serotip 1 in serotip 2.
English: Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule:
Slovenian: En 2-mililitrski odmerek aplicirajte z intramuskularno injekcijo v vratno mišičevje po naslednjem razporedu: Osnovno cepljenje:
English: Do not use in case of hypersensitivity to the active substance, to the adjuvants or to any of the excipients.
Slovenian: Ne uporabite v primerih preobčutljivosti na učinkovino, na dodatke ali na katero koli pomožno snov.
English: Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec, odgovoren za sproščanje serij: LABORATORIOS HIPRA, S.A.
English: Store and transport refrigerated Do not freeze.
Slovenian: Shranjujte in prevažajte v hladilniku Ne zamrzujte.
English: To stimulate active immunisation against swine erysipelas.
Slovenian: Za stimulacijo aktivne imunizacije proti svinjski rdečici.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: Date of first authorisation: 4/07/2014 Date of latest renewal:
Slovenian: Datum pridobitve dovoljenja za promet: 04/07/2014.
English: Store and transport refrigerated (2 ºC - 8 ºC).
Slovenian: Shranjujte in prevažajte pri temperaturi (2 °C - 8 °C).
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALCI BIOLOŠKIH UČINKOVIN IN PROIZVAJALCI ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJ
English: ERYSENG suspension for injection for pigs
Slovenian: ERYSENG suspenzija za injiciranje za prašiče
English: 4.6 Adverse reactions (frequency and seriousness)
Slovenian: 4.6 Neželeni učinki (pogostost in resnost) Zelo pogosti neželeni učinki:
English: Name and address of the manufacturers of the biological active substance
Slovenian: Ime in naslov proizvajalcev biološke učinkovine.
English: Special precautions for use in animals None.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Jih ni.
English: Do not freeze.
Slovenian: Ne zamrzujte
English: Cardboard box, (20 ml, 50 ml, 100ml, and 250ml) bottles (100 ml and 250 ml) and vials (100 ml)
Slovenian: KARTONSKA ŠKATLA, (20 ml, 50 ml, 100ml in 250ml) plastenke (100 ml, 250 ml) in viale (100 ml)
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a 2-fold vaccine dose.
Slovenian: Po dajanju dvojnega odmerka cepiva neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6, ni bilo opaziti.
English: Pharmacotherapeutic group: Immunologicals for suidae, Inactivated bacterial vaccines, erysipelothrix.
Slovenian: Inaktivirana bakterijska cepiva, erysipelothrix.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
Slovenian: PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALCI
English: Potassium chloride Potassium dihydrogen phosphate Simethicone
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi aluminijev hidroksid DEAE-dekstran dinatrijev fosfat dodekahidrat korenina pravega ženšena (ginsenga) kalijev klorid kalijev dihidrogen fosfat simetikon natrijev klorid natrijev hidroksid voda za injekcije
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe
English: No adverse reactions other than already mentioned under section “Adverse reactions” can be expected after the administration of a 2-fold vaccine dose.
Slovenian: Po dajanju dvojnega odmerka cepiva neželeni učinki razen tistih, ki so navedeni v poglavju »Neželeni učinki«, niso pričakovani.
English: Very rare adverse reactions: - Anaphylactic-type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended.
Slovenian: - Spontano se poročali o primerih reakcij anafilaktičnega tipa.
English: Inactivated Erysipelothrix rhusiopathiae, strain R32E11, ....................... ELISA > 3.34 log2 IE50 %* * IE50% - Inhibition ELISA 50%.
Slovenian: inaktivirana bakterija Erysipelothrix rhusiopathiae, sev R32E11 .. ELISA > 3,34 log2 IE50 % * * IE50 % - inhibicija ELISA 50%
English: PACKAGE LEAFLET: ERYSENG suspension for injection for pigs
Slovenian: Suspenzija za injiciranje Suspenzija belkaste barve
English: Tell them immediately if you notice any of these effects.
Slovenian: Nemudoma jim povejte, če opazite kateregakoli od teh učinkov.
English: • allergic reactions as described above
Slovenian: • alergijske reakcije, kot so opisane zgoraj
English: Unopened vial 24 months.
Slovenian: Neodprta viala 24 mesecev
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28 August 2015
Slovenian: Datum prve odobritve: 28 avgust 2015
English: • change or absence of menstrual periods
Slovenian: • spremembe ali izostanek menstruacije
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojnodelovanje z drugimi zdravili in druge oblike interakcij
English: • hair loss: in most cases normal hair growth should return.
Slovenian: • izguba las in dlak: večinoma se obnovi njihova normalna rast.
English: Each box contains 1 vial.
Slovenian: Ena škatla vsebuje 1 vialo.
English: During treatment, you may be given other medicines to maintain the number of your blood cells.
Slovenian: Med zdravljenjem boste morda prejemali zdravila za ohranjanje števila krvnih celic.
English: NL-1316 BN Almere The Netherlands
Slovenian: NL-1316 BN Almere Nizozemska
English: • if the number of your white blood cells is too low.
Slovenian: • če imate premajhno število belih krvnih celic,
English: The first interim analysis was planned 3 years after the date when half of study enrollment was done.
Slovenian: Prva vmesna analiza je bila načrtovana 3 leta po datumu, ko je bila opravljena polovica vključevanja v študijo.
English: TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Slovenian: (26,8-no) ČDN = čas do napredovanja; “no” pomeni, ni bilo mogoče oceniti ali še ni doseženo.
English: • Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanjetveganj (RMP)
English: Frequency not known (cannot be estimated from available data):
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: • loss of appetite (anorexia)
Slovenian: • izguba apetita (anoreksija)
English: After opening of the vial
Slovenian: Po odprtju viale
English: 3 (see section 4.2).
Slovenian: 3 (glejte poglavje 4.2).
English: • change in the colour of your nails, which may detach
Slovenian: • sprememba barve nohtov, ki lahko odstopijo
English: If the patient continues to experience these reactions at 60 mg/m 2, the treatment should be discontinued.
Slovenian: Če bolnik tudi pri odmerku 60 mg/m 2 še doživlja te reakcije, je treba zdravljenje prekiniti.
English: • bleeding from the nose
Slovenian: • krvavitev iz nosu
English: Its common name is docetaxel.
Slovenian: Njegovo splošno ime je docetaksel.
English: Name and address of the manufacturers responsible for batch release Hospira UK Limited
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij Hospira UK Limited
English: Between infusions of Taxespira the following may occur, and the frequency may vary with the combinations of medicines that are received:
Slovenian: Med posameznimi infuzijami zdravila Taxespira se lahko pojavi naslednje in pogostnost se lahko razlikuje glede na kombinacijo zdravil, ki so uporabljena:
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Slovenian: Opredelitev pogostnosti je: zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10); občasno (≥ 1/1.000 do < 1/100); redko (≥ 1/10.000 do < 1/1.000); zelo redko (< 1/10.000),neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: If crystals appear, the solution must no longer be used and shall be discarded.
Slovenian: Če se v raztopini pojavijo kristali, raztopine ne smete več uporabiti in jo je treba zavreči.
English: Contraception in males and females An effective method of contraception should be used during treatment.
Slovenian: Kontracepcija pri moških in ženskah Med zdravljenjem se mora uporabljati učinkovita metodo kontracepcije.
English: The amount of alcohol in this medicinal product may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).
Slovenian: Količina alkohola v tem zdravilu lahko vpliva na osrednje živčevje (del živčevja, ki obsega možgane in hrbtenjačo).
English: G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7 % of the cycles).
Slovenian: G-CSF so uporabili za sekundarno profilakso pri 19,3 % bolnikov (10,7 % ciklusov).
English: Recommendations for the safe handling
Slovenian: Priporočila za varno ravnanje z zdravilom
English: All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Slovenian: Vse materiale, uporabljene pri razredčevanju in aplikaciji, je treba odstraniti skladno s standardnimi postopki.
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Taxespira.
Slovenian: Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na zdravilo Taxespira.
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 ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Before each treatment with Taxespira, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Taxespira.
Slovenian: Pred vsako uporabo zdravila Taxespira boste opravili preiskave krvi za ugotovitev, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite zdravilo Taxespira.
English: The safety and efficacy of Taxespira in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Taxespira za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
English: Although majority of cases occurred during the first or second cycle of docetaxel containing regimen, enterocolitis could develop at any time, and could lead to death as early as on the first day of onset.
Slovenian: Večina primerov se je sicer pojavila med prvim ali drugim ciklusom sheme, ki je vključevala docetaksel, toda enterokolitis se lahko razvije kadarkoli in lahko povzroči smrt že prvi dan, ko se pojavi.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu
English: If this happens, you must tell your doctor immediately.
Slovenian: Če se to zgodi, morate nemudoma obvestiti zdravnika.
English: Ask your doctor for advice before being given any medicine.
Slovenian: Posvetujte se z zdravnikom, preden vzamete katerokoli zdravilo.
English: Taxespira will be given by infusion into one of your veins (intravenous use).
Slovenian: Zdravilo Taxespira boste dobili v infuziji v eno od ven (intravenska uporaba).
English: Older people treated with TCF should be closely monitored.
Slovenian: Starejše bolnike, ki dobivajo TCF, je treba natančno nadzirati.
English: Once added to the infusion bag
Slovenian: Po dodajanju v infuzijsko vrečo
English: Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Slovenian: razlika zdravljenj: 7,1 % [95 % IZ: 0,7; 13,5] *: Korigirano za multiple primerjave in prilagojeno za stratifikacijske faktorje (stadij bolezni in predel zdravljenja) na podlagi ocenljive populacije bolnikov.
English: For combination with trastuzumab, adverse events (all grades) reported in ≥10% are displayed.
Slovenian: Pri kombinaciji s trastuzumabom so predstavljeni neželeni učinki (vseh stopenj) poročani v ≥ 10 %.
English: Taxespira contains alcohol.
Slovenian: Zdravilo Taxespira vsebuje alkohol.
English: Other medicines and Taxespira
Slovenian: Druga zdravila in zdravilo Taxespira
English: This is because Taxespira 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 Taxespira 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: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanjastrojev
English: Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomized.
Slovenian: Primarna profilaktična uporaba G-CSF je postala v kraku TAC obvezna po randomizaciji 230 bolnic.