natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
• the CHMP considered the requested biowaiver for the 2, 3 and 4 mg strengths to be acceptable, 
• Prav tako je menil, da je zahtevano izvzetje iz obveznosti izvedbe študij biološke enakovrednosti za 2-, 3- in 4-miligramsko jakost dopustno,
The Applicant stated that it considered the ethical concerns linked to the risk of hypoglycaemia in healthy adults when designing the bioequivalence study. 
Predlagatelj je navedel, da je ob zasnovi študije biološke enakovrednosti upošteval etične pomisleke v zvezi s tveganjem hipoglikemične reakcije pri zdravih odraslih osebah.
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. 
Zato po njegovem mnenju ni zelo verjetno, da bi razlike med posameznimi jakostmi vplivale na sproščanje zdravilne učinkovine in vivo.
The CHMP also considered the fact that the particle size of the active substance is controlled to be reassuring. 
Menil je še, da k večji gotovosti pripomore tudi dejstvo, da je zagotovljen nadzor nad velikostjo delcev zdravilne učinkovine.
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. 
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.
Packaging Content (concentration) 
Farmacevtska oblika Pot uporabe Ovojnina Vsebina (koncentracija)
Package size l t o r 
3 mg/ml
Strength Pharmaceutical Form 
Velikost pakiranja
Duration of immunity: six months. 
Trajanje imunosti: šest mesecev.
ATCvet code: QI09AB03. 
Oznaka ATC vet: QI09AB03.
Onset of immunity: three weeks after completion of the basic vaccination scheme. 
Nastop imunosti: tri tedne po zaključku osnovne sheme cepljenja.
LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Gerona) SPAIN 
LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Gerona) ŠPANIJA
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. 
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.
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. 
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.
Special warnings for each target species: Vaccinate only healthy animals. 
Posebna opozorila za vsako ciljno živalsko vrsto: Cepite le zdrave živali.
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. 
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.
Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule: 
En 2-mililitrski odmerek aplicirajte z intramuskularno injekcijo v vratno mišičevje po naslednjem razporedu: Osnovno cepljenje:
Do not use in case of hypersensitivity to the active substance, to the adjuvants or to any of the excipients. 
Ne uporabite v primerih preobčutljivosti na učinkovino, na dodatke ali na katero koli pomožno snov.
Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A. 
Imetnik dovoljenja za promet z zdravilom in proizvajalec, odgovoren za sproščanje serij: LABORATORIOS HIPRA, S.A.
Store and transport refrigerated Do not freeze. 
Shranjujte in prevažajte v hladilniku Ne zamrzujte.
To stimulate active immunisation against swine erysipelas. 
Za stimulacijo aktivne imunizacije proti svinjski rdečici.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Date of first authorisation: 4/07/2014 Date of latest renewal: 
Datum pridobitve dovoljenja za promet: 04/07/2014.
Store and transport refrigerated (2 ºC - 8 ºC). 
Shranjujte in prevažajte pri temperaturi (2 °C - 8 °C).
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALCI BIOLOŠKIH UČINKOVIN IN PROIZVAJALCI ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJ
ERYSENG suspension for injection for pigs 
ERYSENG suspenzija za injiciranje za prašiče
4.6 Adverse reactions (frequency and seriousness) 
4.6 Neželeni učinki (pogostost in resnost) Zelo pogosti neželeni učinki:
Name and address of the manufacturers of the biological active substance 
Ime in naslov proizvajalcev biološke učinkovine.
Special precautions for use in animals None. 
Posebni previdnostni ukrepi za uporabo pri živalih Jih ni.
Do not freeze. 
Ne zamrzujte
Cardboard box, (20 ml, 50 ml, 100ml, and 250ml) bottles (100 ml and 250 ml) and vials (100 ml) 
KARTONSKA ŠKATLA, (20 ml, 50 ml, 100ml in 250ml) plastenke (100 ml, 250 ml) in viale (100 ml)
No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a 2-fold vaccine dose. 
Po dajanju dvojnega odmerka cepiva neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6, ni bilo opaziti.
Pharmacotherapeutic group: Immunologicals for suidae, Inactivated bacterial vaccines, erysipelothrix. 
Inaktivirana bakterijska cepiva, erysipelothrix.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND 
PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALCI
Potassium chloride Potassium dihydrogen phosphate Simethicone 
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
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. 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe
No adverse reactions other than already mentioned under section “Adverse reactions” can be expected after the administration of a 2-fold vaccine dose. 
Po dajanju dvojnega odmerka cepiva neželeni učinki razen tistih, ki so navedeni v poglavju »Neželeni učinki«, niso pričakovani.
Very rare adverse reactions: - Anaphylactic-type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended. 
- Spontano se poročali o primerih reakcij anafilaktičnega tipa.
Inactivated Erysipelothrix rhusiopathiae, strain R32E11, ....................... ELISA > 3.34 log2 IE50 %* * IE50% - Inhibition ELISA 50%. 
inaktivirana bakterija Erysipelothrix rhusiopathiae, sev R32E11 .. ELISA > 3,34 log2 IE50 % * * IE50 % - inhibicija ELISA 50%
PACKAGE LEAFLET: ERYSENG suspension for injection for pigs 
Suspenzija za injiciranje Suspenzija belkaste barve
Tell them immediately if you notice any of these effects. 
Nemudoma jim povejte, če opazite kateregakoli od teh učinkov.
• allergic reactions as described above 
• alergijske reakcije, kot so opisane zgoraj
Unopened vial 24 months. 
Neodprta viala 24 mesecev
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28 August 2015 
Datum prve odobritve: 28 avgust 2015
• change or absence of menstrual periods 
• spremembe ali izostanek menstruacije
4.5 Interaction with other medicinal products and other forms of interaction 
4.5 Medsebojnodelovanje z drugimi zdravili in druge oblike interakcij
• hair loss: in most cases normal hair growth should return. 
• izguba las in dlak: večinoma se obnovi njihova normalna rast.
Each box contains 1 vial. 
Ena škatla vsebuje 1 vialo.
During treatment, you may be given other medicines to maintain the number of your blood cells. 
Med zdravljenjem boste morda prejemali zdravila za ohranjanje števila krvnih celic.
• if the number of your white blood cells is too low. 
• če imate premajhno število belih krvnih celic,
The first interim analysis was planned 3 years after the date when half of study enrollment was done. 
Prva vmesna analiza je bila načrtovana 3 leta po datumu, ko je bila opravljena polovica vključevanja v študijo.
TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached. 
(26,8-no) ČDN = čas do napredovanja; “no” pomeni, ni bilo mogoče oceniti ali še ni doseženo.
• Risk Management Plan (RMP) 
• Načrt za obvladovanjetveganj (RMP)
Frequency not known (cannot be estimated from available data): 
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
• loss of appetite (anorexia) 
• izguba apetita (anoreksija)
After opening of the vial 
Po odprtju viale
3 (see section 4.2). 
3 (glejte poglavje 4.2).
• change in the colour of your nails, which may detach 
• sprememba barve nohtov, ki lahko odstopijo
If the patient continues to experience these reactions at 60 mg/m 2, the treatment should be discontinued. 
Če bolnik tudi pri odmerku 60 mg/m 2 še doživlja te reakcije, je treba zdravljenje prekiniti.
• bleeding from the nose 
• krvavitev iz nosu
Its common name is docetaxel. 
Njegovo splošno ime je docetaksel.
Name and address of the manufacturers responsible for batch release Hospira UK Limited 
Ime in naslov izdelovalca, odgovornega za sproščanje serij Hospira UK Limited
Between infusions of Taxespira the following may occur, and the frequency may vary with the combinations of medicines that are received: 
Med posameznimi infuzijami zdravila Taxespira se lahko pojavi naslednje in pogostnost se lahko razlikuje glede na kombinacijo zdravil, ki so uporabljena:
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). 
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).
If crystals appear, the solution must no longer be used and shall be discarded. 
Če se v raztopini pojavijo kristali, raztopine ne smete več uporabiti in jo je treba zavreči.
Contraception in males and females An effective method of contraception should be used during treatment. 
Kontracepcija pri moških in ženskah Med zdravljenjem se mora uporabljati učinkovita metodo kontracepcije.
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). 
Količina alkohola v tem zdravilu lahko vpliva na osrednje živčevje (del živčevja, ki obsega možgane in hrbtenjačo).
G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7 % of the cycles). 
G-CSF so uporabili za sekundarno profilakso pri 19,3 % bolnikov (10,7 % ciklusov).
Recommendations for the safe handling 
Priporočila za varno ravnanje z zdravilom
All materials that have been utilised for dilution and administration should be disposed of according to standard procedures. 
Vse materiale, uporabljene pri razredčevanju in aplikaciji, je treba odstraniti skladno s standardnimi postopki.
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Taxespira. 
Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na zdravilo Taxespira.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription. 
Obvestite svojega zdravnika ali bolnišničnega farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
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. 
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.
The safety and efficacy of Taxespira in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established. 
Varnost in učinkovitost zdravila Taxespira za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
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. 
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.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu
If this happens, you must tell your doctor immediately. 
Če se to zgodi, morate nemudoma obvestiti zdravnika.
Ask your doctor for advice before being given any medicine. 
Posvetujte se z zdravnikom, preden vzamete katerokoli zdravilo.
Taxespira will be given by infusion into one of your veins (intravenous use). 
Zdravilo Taxespira boste dobili v infuziji v eno od ven (intravenska uporaba).
Older people treated with TCF should be closely monitored. 
Starejše bolnike, ki dobivajo TCF, je treba natančno nadzirati.
Once added to the infusion bag 
Po dodajanju v infuzijsko vrečo
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. 
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.
For combination with trastuzumab, adverse events (all grades) reported in ≥10% are displayed. 
Pri kombinaciji s trastuzumabom so predstavljeni neželeni učinki (vseh stopenj) poročani v ≥ 10 %.
Taxespira contains alcohol. 
Zdravilo Taxespira vsebuje alkohol.
Other medicines and Taxespira 
Druga zdravila in zdravilo Taxespira
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. 
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.
4.7 Effects on ability to drive and use machines 
4.7 Vpliv na sposobnost vožnje in upravljanjastrojev
Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomized. 
Primarna profilaktična uporaba G-CSF je postala v kraku TAC obvezna po randomizaciji 230 bolnic.
Docetaxel belongs to the group of anti-cancer medicines called taxoids. 
Docetaksel spada v skupino zdravil za zdravljenje raka, imenovanih taksoidi.
If you had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel, which may be more severe. 
Če ste imeli alergijsko reakcijo na paklitaksel, se vam lahko pojavi tudi alergijska reakcija na docetaksel, ki pa je lahko hujša.
Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen 
Stratificiran log-rang test *Prag statistične značilnosti = 0,0175 **PSA: prostatični specifični antigen
• redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body) 
• pordelost in otekanje dlani ali podplatov, ki lahko povzroči olupljenje kože (to se lahko pojavi tudi na rokah, obrazu ali telesu)
Taxespira contains ethanol (alcohol) 
Zdravilo Taxespira vsebuje etanol (alkohol)
This leaflet was last revised in {month YYYY}. 
Navodilo je bilo nazadnje revidirano dne mesec LLLL
Pharmacotherapeutic group: antineoplastic agents, taxanes, ATC Code: L01CD02 
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe, taksani, oznaka ATC: L01CD02
• infections, decrease in the number of red blood cells (anaemia), or white blood cells (which are important in fighting infection) and platelets (important in blood clotting) 
• okužbe, zmanjšanještevila rdečih krvnih celic (anemija), belih krvnih celic (ki so pomembne za premagovanje okužbe) in trombocitov (pomembni za strjevanje krvi)
In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastro-intestinal disorders. 
V približno 20 % teh primerov ni bilo nobenih dejavnikov tveganja za akutno ledvično odpoved, sočasnih nefrotoksičnih zdravil in bolezni prebavil.
Use the vial immediately after its opening. 
Vialo je treba uporabiti takoj po odprtju.
See also section “Taxespira contains ethanol (alcohol)” below. 
Glejte tudi poglavje "Zdravilo Taxespira vsebuje etanol (alkohol)" spodaj.
3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia. 
3) pa 7 dni), anemija, alopecija, navzea, bruhanje, stomatitis, driska in astenija.
What you need to know before you use Taxespira 
Kaj morate vedeti, preden boste uporabili zdravilo Taxespira
Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy) 
Vnetje pljuč se lahko razvije tudi, če se zdravljenje z docetakselom uporablja sočasno z radioterapijo)
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Taxespira may be harmful for the unborn baby. 
Med zdravljenjem z zdravilom Taxespira ne smete zanositi in morate uporabljati učinkovito kontracepcijsko zaščito, ker zdravilo Taxespira lahko škoduje vašemu nerojenemu otroku.
What Taxespira is and what it is used for 
Kaj je zdravilo Taxespira in za kaj ga uporabljamo
Hazard ratio (TAC/FAC) 
Razmerje ogroženosti (TAC/FAC)
Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4. 
Docetaksel se metabolizira s CYP3A4, za prednizon pa je znano, da inducira CYP3A4.
Taxespira will be administered to you by a healthcare professional. 
Zdravilo Taxespira vam bo dal pristojni zdravstveni delavec.
The name of this medicine is Taxespira. 
To zdravilo se imenuje Taxespira.
The amount of alcohol in this medicinal product and the side effects of the product may impair the ability to drive or use machines (see sections 4.4 and 4.8). 
Količina alkohola v tem zdravilu in neželeni učinki zdravila lahko poslabšajo sposobnost vožnje in upravljanja s stroji (glejte poglavji 4.4 in 4.8).
Symptoms such as early abdominal pain and tenderness, fever, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly. 
Simptomi kot so: abdominalne bolečine in občutljivost, pireksija, driska z ali brez nevtropenije, so lahko zgodnja manifestacija resne gastrointestinalne toksičnosti ter jih je potrebno nemudoma ovrednotiti in zdraviti.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
B. POGOJI ALI OMEJITVEGLEDE OSKRBE IN UPORABE
• decrease in blood pressure; irregular or rapid heart beat 
• znižanje krvnega tlaka, nereden ali hiter srčni utrip
• Mitoxantrone 12 mg/m 
• Mitoksantron12 mg/m
In case of white blood cells disturbances, you may experience associated fever or infections. 
Če imate spremenjeno število belih krvnih celic, se lahko pojavijo zvišana telesna temperatura ali okužbe.
Taxespira was administered as a 1-hour infusion, all other medicinal products were given intravenously on day 1 every three weeks. 
Zdravilo Taxespira je bilo uporabljeno v 1-urni infuziji, vsa druga zdravila pa intravensko 1. dan na tri tedne.
Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4) 
Nevtropenija (4. stopnje) Febrilna nevtropenija Nevtropenična okužba Nevtropenična okužba (3.-4. stopnja)
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia. 
Bolezni krvi in limfatičnega sistema Redki: krvavitve povezane s trombocitopenijo stopnje 3/4.
Discuss with your doctor if you suffer from alcohol dependency, epilepsy, or liver impairment. 
Posvetujte se z zdravnikom, če ste odvisni od alkohola, imate epilepsijo ali okvaro jeter.