FrancophonIA/ELRC3.0 huggingface dataset:
English: Infection can also cause inflammation and swelling of the throat, leading to difficulties in swallowing and breathing, and infection can affect other parts of the body such as the blood, lungs, skin, bones, and joints.
Slovenian: Okužba lahko prizadene tudi druge dele telesa kot so kri, pljuča, koža, kosti in sklepi.
English: Very Common Somnolence Uncommon Hypotonia
Slovenian: Bolezni živčevja zelo pogosti zaspanost občasni hipotonija
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora občasni kašelj
English: Anti-diphtheria (≥ 0.1 IU/mL) Anti-tetanus (≥ 0.1 IU/mL) Anti-PT (vaccine response) Anti-FHA (vaccine response) Anti-PRN (vaccine response) Anti-FIM (vaccine response) Anti-Polio type 1 (≥ 1:8 dilution) Anti-Polio type 2 (≥ 1:8 dilution) Anti-Polio type 3 (≥ 1:8 dilution) Anti-HBs Ag (≥ 10 mIU/mL)
Slovenian: Protitelesa proti PT (odziv na cepljenje) Protitelesa proti FHA (odziv na cepljenje) Protitelesa proti PRN (odziv na cepljenje) Protitelesa proti FIM (odziv na cepljenje) Protitelesa proti poliovirusu tipa 1 (razredčeno ≥ 1:8)
English: Carton for multipack containing 5 packs of 10 prefilled syringes without needle.
Slovenian: Škatla za združeno pakiranje 5 paketov po 10 napolnjenih injekcijskih brizg brez igle.
English: Haemophilus influenzae type b polysaccharide
Slovenian: polisaharid Haemophilusa influenzae tipa b
English: If there is anything you do not understand, ask your doctor, pharmacist or nurse to explain.
Slovenian: Če česa ne razumete, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Vaxelis may be administered simultaneously with pneumococcal polysaccharide conjugate vaccines, rotavirus vaccines, measles, mumps, rubella (MMR) and varicella containing vaccines and meningococcal C conjugate vaccines.
Slovenian: Cepivo Vaxelis se lahko daje sočasno s konjugiranimi pnevmokoknimi polisaharidnimi cepivi, cepivi proti rotavirusom, ošpicam, mumpsu, rdečkam (MMR) in cepivi proti noricam, ter s konjugiranimi cepivi proti meningokokom skupine C.
English: Hrvatska Merck Sharp & Dohme d.o.o.
Slovenian: Merck Sharp & Dohme d.o.o.
English: With hepatitis B vaccination at birth Without hepatitis B vaccination at birth Anti-PRP (≥ 0.15 µg/mL)
Slovenian: s cepljenjem proti hepatitisu B ob rojstvu brez cepljenja proti hepatitisu B ob rojstvu
English: • Common side effects (may affect up to 1 in 10 people) are: diarrhoea hard mass, lump (nodule) at the injection site bruising at the injection site
Slovenian: • Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 cepljenih) so: driska, zatrdlina, vozlič (nodul) na mestu injiciranja, modrica na mestu injiciranja.
English: Anti-Polio type 1 (≥ 1:8 dilution) Anti-Polio type 2 (≥ 1:8 dilution) Anti-Polio type 3 (≥ 1:8 dilution)
Slovenian: Protitelesa proti poliovirusu tipa 2 (razredčeno ≥ 1:8)
English: The most frequently reported adverse reactions after Vaxelis administration were irritability, crying, somnolence, injection site reactions (pain, erythema, swelling), pyrexia (≥38
Slovenian: Najpogosteje poročani neželeni učinki po cepljenju s cepivom Vaxelis so bili razdražljivost, jok, zaspanost, reakcije na mestu injiciranja (bolečina, rdečina, oteklina), povišana telesna temperatura (≥ 38 °C), zmanjšan apetit in bruhanje.
English: Anti-diphtheria (≥ 0.01 IU/mL) Anti-tetanus (≥ 0.01 IU/mL) Anti-PT (vaccine response) Anti-FHA (vaccine response) Anti-PRN (vaccine response)
Slovenian: Protitelesa proti davici (≥ 0,1 i.e./ml) Protitelesa proti tetanusu (≥ 0,1 i.e./ml)
English: Prior to administration, the pre-filled syringe should be shaken gently in order to obtain a homogeneous, whitish, cloudy suspension.
Slovenian: Pred uporabo napolnjeno injekcijsko brizgo narahlo pretresite, da dobite homogeno, belkasto, motno suspenzijo.
English: The active substances per dose (0.5 mL):
Slovenian: Učinkovine na odmerek (0,5 ml):
English: If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
Slovenian: Če mora otrok prejeti drugi odmerek cepiva proti hepatitisu B pred to starostjo, je treba uporabiti monovalentno cepivo proti hepatitisu B. Cepivo Vaxelis je mogoče uporabljati v mešanem šestvalentnem/petvalentnem/šestvalentnem kombiniranem programu imunizacije.
English: Vaxelis suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus type b conjugate vaccine (adsorbed).
Slovenian: Vaxelis suspenzija za injiciranje v napolnjeni injekcijski brizgi konjugirano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in Haemophilusu tipa b (adsorbirano)
English: Uniform, cloudy, white to off-white suspension.
Slovenian: Enakomerna, motna, bela ali skoraj bela suspenzija.
English: • If your child get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: • Če pri otroku opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Adverse Reactions
Slovenian: Protitelesa proti
English: {Label - Prefilled Syringe}
Slovenian: {Nalepka - napolnjena injekcijska brizga}
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja občasni izpuščaj, hiperhidroza
English: Posology
Slovenian: Pojavnost
English: If your child gets any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če pri otroku opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), with 2 separate needles - pack size of 1 or 10.
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (iz butila) in pokrovčkom (iz butila), z 2 ločenima iglama - velikost pakiranja 1 ali 10.
English: b- Tabulated list of adverse reactions
Slovenian: b- Seznam neželenih učinkov, prikazan v preglednici
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), without needle - multipack of 5 packs of 10.
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (iz butila) in pokrovčkom (iz butila), brez igle - skupno pakiranje 5 paketov po 10.
English: Diphtheria Toxoid
Slovenian: toksoid davice
English: If your child experiences any of the following side effects, please tell your doctor, nurse or pharmacist.
Slovenian: Če pri otroku opazite katerega od naslednjih neželenih učinkov, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), with 1 separate needle - pack size of 1 or 10.
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (iz butila) in pokrovčkom (iz butila), z 1 ločeno iglo - velikost pakiranja 1 ali 10.
English: 2, 4, 6 months
Slovenian: 6.3 Rok uporabnosti
English: Vaxelis injection
Slovenian: Vaxelis injekcija i. m.
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), without needle - pack size of 1 or 10.
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (iz butila) in pokrovčkom (iz butila), brez igle - velikost pakiranja 1 ali 10.
English: Prior to immunisation
Slovenian: Pred cepljenjem
English: Metabolism and nutrition disorders
Slovenian: Okužbe in parazitske bolezni občasni rinitis
English: Diarrhoea Uncommon Abdominal pain
Slovenian: Žilne bolezni občasni bledica
English: 1 pre-filled syringe in a blister + 2 alcohol pads
Slovenian: 1 napolnjena injekcijska brizga v pretisnem omotu + 2 alkoholna zloženca
English: After first opening
Slovenian: Po prvem odprtju
English: Survival (months)
Slovenian: Preživetje (mesecev)
English: Date of first authorisation: 10 June 2010 Date of latest renewal: 28 May 2015
Slovenian: Datum prve odobritve: 10. junij 2010 Datum zadnjega podaljšanja: 28. maj 2015
English: EXP: Use immediately after opening.
Slovenian: EXP: Uporabite takoj po odprtju.
English: Study results Study GOG-0179
Slovenian: Izsledki študije GOG-0179
English: In some cases you may need a blood transfusion.
Slovenian: V nekaterih primerih bo lahko potrebna transfuzija krvi;
English: Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2. vendar priporočil o odmerjanju ni mogoče dati.
English: If you feel tired or weak, do not drive or use machines.
Slovenian: Če se počutite utrujeno ali šibko, ne smete voziti ali upravljati s stroji.
English: 1316 BN, Almere The Netherlands
Slovenian: 1316 BN, Almere Nizozemska ali
English: • the results of blood tests carried out before treatment
Slovenian: • izvidov krvnih preiskav, opravljenih pred začetkom zdravljenja,
English: Talk to your doctor for advice on how to minimise the risk of bleeding.
Slovenian: Posvetujte se s svojim zdravnikom o tem, kako bi lahko kar najbolj zmanjšali tveganje za krvavitve;
English: Mean half-life increased from 1.9 hours to 4.9 hours.
Slovenian: Srednja razpolovna doba se je podaljšala z 1,9 ure na 4,9 ur.
English: It may harm a baby conceived before, during or soon after treatment.
Slovenian: Škoduje lahko otroku, spočetemu pred zdravljenjem, med zdravljenjem ali kmalu po zdravljenju.
English: Area under the curve increased approximately in proportion to the increase in dose.
Slovenian: Površina pod krivuljo je naraščala približno sorazmerno s povečevanjem odmerka.
English: The carcinogenic potential of topotecan has not been studied.
Slovenian: Kancerogenega potenciala topotekana niso raziskovali.
English: Serious side effects: tell your doctor
Slovenian: Resni neželeni učinki: obvestite svojega zdravnika
English: The median time to response in clinical studies was 7.6-11.6 weeks.
Slovenian: Srednji odzivni čas je v kliničnih študijah znašal od 7,6 do 11,6 tednov.
English: • if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na topotekan ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: Topotecan is not recommended for pregnant women.
Slovenian: Topotekan ni priporočljiv za nosečnice.
English: Volume of distribution was slightly decreased and thus half-life only increased by 14 %.
Slovenian: Porazdelitveni volumen je bil malo zmanjšan, zato se je razpolovna doba podaljšala le za 14 %.
English: Overall, 87 complete and partial responses were observed, with 13 of these occurring during cycles 5 and 6 and 3 occurring thereafter.
Slovenian: Skupno so zasledili 87 popolnih ali delnih odzivov, od česar se jih je 13 pojavilo med cikloma 5 ali 6, trije pa v poznejših ciklih.
English: • High body temperature (fever).
Slovenian: • visoka telesna temperatura (vročina),
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) and not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena, kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana (je ni mogoče oceniti iz razpoložljivih podatkov).
English: Honey Lane Hurley
Slovenian: Honey Lane
English: Women of childbearing potential/ Contraception in males and females
Slovenian: Ženske v rodni dobi/Kontracepcija pri moških in ženskah
English: Storage, Use, Handling & Disposal of Topotecan Hospira
Slovenian: Shranjevanje, uporaba, ravnanje in odstranjevanje zdravila Topotecan Hospira
English: In these studies there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Slovenian: V teh študijah ni bilo očitnih razlik v farmakokinetiki topotekana med otroci, mladostniki in mlajšimi odraslimi s solidnimi tumorji ali levkemijo, vendar so podatki preveč omejeni, da bi lahko podali dokončen sklep.
English: • your body size (surface area measured in square metres)
Slovenian: • velikosti vašega telesa (telesne površine, izraženo v kvadratnih metrih),
English: Your doctor will decide with you whether Topotecan Hospira therapy is better than further treatment with your initial chemotherapy.
Slovenian: Zdravnik se bo skupaj z vami odločil, ali je zdravljenje z zdravilom Topotecan Hospira boljše za vas od nadaljnjega zdravljenja s prvotno kemoterapijo.
English: Please refer to the SPC for further details.
Slovenian: Za dodatne informacije glejte SPC.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Slovenian: Poleg tega je pri 5 % vseh zdravljenih bolnikov (1 % ciklusov zdravljenja) nastopila sepsa (glejte poglavje 4.4).
English: Unopened vial 3 years
Slovenian: Neodprto zdravilo 3 leta
English: Topotecan also had a high volume of distribution, about 132l (SD 57), and a relatively short half-life of 2-3 hours.
Slovenian: Topotekan ima tudi velik porazdelitveni volumen, približno 132 l (SD 57), in sorazmerno kratko razpolovno dobo, 2 do 3 ure.
English: Before you are given this medicine your doctor needs to know :
Slovenian: Preden boste prejeli to zdravilo, morate obvestiti zdravnika:
English: The frequency of some side effects is not known (events from spontaneous reports and the frequency cannot be estimated from the available data):
Slovenian: Za nekatere neželene učinke pogostnost ni znana (podatki o njih izhajajo iz spontanih poročil, tako da njihove pogostnosti ni mogoče ugotoviti iz razpoložljivih podatkov):
English: The dose of topotecan you are given will be worked out by your doctor, based on:
Slovenian: Odmerek topotekana, ki ga boste prejeli, bo zdravnik določil na podlagi:
English: If not used immediately, Topotecan Hospira can be used for up to 24 hours when stored in the fridge (protected from light) or at room temperature (in normal daylight conditions).
Slovenian: Če ni uporabljeno takoj, lahko zdravilo Topotecan Hospira uporabljate še največ 24 ur, če ga shranjujete v hladilniku (zaščitenega pred svetlobo) ali pri sobni temperaturi (v pogojih normalne dnevne svetlobe).
English: Topotecan Hospira helps to destroy tumours.
Slovenian: Topotecan Hospira pomaga uničevati tumorje.
English: The pharmacokinetics of topotecan given as a 30-minute infusion for 5 days were evaluated in two studies.
Slovenian: Farmakokinetiko topotekana, danega v obliki 30-minutne infuzije v času 5 dni, so ovrednotili v dveh študijah.
English: Of the patients who received more than 6 cycles of therapy, 91 % completed the study as planned or were treated until disease progression, with only 3 % withdrawn for adverse events.
Slovenian: Od bolnic, ki so bile deležne več kot šest ciklov zdravljenja, jih je 91 % dokončalo raziskavo kot je bilo predvideno, ali pa so jih zdravili, dokler je bila bolezen v progresiji.
English: • the disease being treated.
Slovenian: • bolezni, zaradi katere se zdravite.
English: Do not restart breast-feeding until the doctor tells you it is safe to do so.
Slovenian: Z dojenjem tudi ne smete ponovno začeti, dokler vam zdravnik ne pove, da je to varno.
English: Topotecan half-life was increased by about 30 % but no clear change in volume of distribution was observed.
Slovenian: Razpolovna doba topotekana se je podaljšala za približno 30 %, medtem ko jasne spremembe v porazdelitvenem volumenu niso opazili.
English: • Feeling generally weak and tired (temporary anaemia).
Slovenian: • občutek splošne oslabelosti in utrujenosti (začasna anemija).
English: (platelets between 25.0 and 50.0 x 10
Slovenian: (število trombocitov med 25,0 in 50,0 x 10
English: If your partner becomes pregnant during your treatment, tell your doctor immediately.
Slovenian: Če med zdravljenjem zanosi vaša partnerka, o tem nemudoma obvestite zdravnika.
English: • Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
Slovenian: • nenavadne podplutbe ali krvavitve, ki nastanejo zaradi zmanjšanja števila celic za strjevanje krvi.
English: Maidenhead SL6 6RJ
Slovenian: SL6 6RJ
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Slovenian: Kjer je možno, bi moralo biti nadaljne ravnanje klinično indicirano ali priporočeno s strani nacionalnega centra za zastrupitve.
English: Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection.
Slovenian: Med vsemi bolniki, ki so jih zdravili v kliničnih študijah (vključno s tistimi, ki so imeli hudo nevtropenijo, in tistimi, pri katerih se huda nevtropenija ni pojavila) jih je imelo 11 % (4 % ciklusov zdravljenja) zvišano telesno temperaturo in 26 % (9 % ciklusov zdravljenja) okužbe.
English: If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Slovenian: Če bolnik dobro prenaša zdravljenje, lahko s to shemo nadaljujete, dokler bolezen ne napreduje (glejte poglavji 4.8 in 5.1).
English: There is no known antidote for topotecan overdose.
Slovenian: Ni znanega antidota za preveliko odmerjanje topotekana.
English: Each vial contains 4 ml of concentrate.
Slovenian: Vsaka viala vsebuje po 4 ml koncentrata.
English: This increase is considered unlikely to be of clinical relevance.
Slovenian: Verjetnost, da bi bilo to povečanje klinično pomembno, pa je majhna.
English: In a population study, a number of factors including age, weight and ascites had no significant effect on clearance of total topotecan (active and inactive form).
Slovenian: V populacijski študiji številni različni dejavniki, na primer starost, telesna masa in ascites, niso pomembno vplivali na očistek celotnega topotekana (aktivne in neaktivne oblike).
English: Adverse reactions are listed below by system organ class and absolute frequency (all reported events).
Slovenian: Spodaj navedeni neželeni učinki so razvrščeni po organskih sistemih in po absolutni pogostnosti (glede na vse prijavljene dogodke).
English: As would be expected, patients with poor performance status (PS>1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Slovenian: Kot je mogoče pričakovati, se bolniki s slabšo telesno zmogljivostjo(PS > 1) slabše odzivajo na zdravilo in imajo večjo incidenco zapletov, kot so zvišana telesna temperatura, okužbe in sepsa (glejte poglavje 4.8).
English: In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A, nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Slovenian: In vitro topotekan ni zaviral delovanja človeških izoencimov citokroma P450 (CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A ali CYP4A) niti človeških citosolskih encimov dihidropirimidin oksidaze ali ksantin oksidaze.
English: Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to PS 3.
Slovenian: Pomembna je pravilna ocena bolnikovega stanja na začetku zdravljenja in treba je paziti, da se mu stanje ne poslabša na 3. stopnjo.
English: Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Slovenian: Primerjava farmakokinetičnih parametrov ni pokazala nobenih sprememb v farmakokinetiki v času 5 dni uporabe topotekana.
English: − Personnel should be trained to prepare and administer the medicinal product.
Slovenian: − Osebje mora biti usposobljeno za pripravo in dajanje zdravila.
English: − Severe hypersensitivity to the active substance or to any of the excipients.
Slovenian: − huda preobčutljivost na učinkovino ali katerokoli pomožno snov,
English: Severe neutropenia lasted beyond seven days in 11 % of courses overall.
Slovenian: Huda nevtropenija je trajala več kot sedem dni pri 11 % vseh ciklusov zdravljenja.
English: • advanced cervical cancer if surgery or radiotherapy treatment is not possible.
Slovenian: • napredovalega raka materničnega vratu, če zdravljenje s kirurškim posegom ali obsevanjem ni mogoče.
English: Concentrate for solution for infusion (sterile concentrate).
Slovenian: Koncentrat za raztopino za infundiranje (sterilni koncentrat)
English: Anaemia:
Slovenian: Anemija:
English: topotecan was discontinued if the dose had been reduced to 1.0 mg/m 2/day and a further dose reduction was required to manage adverse effects.
Slovenian: kliničnih preskušanjih so topotekan ukinili, če je bil odmerek že zmanjšan na 1,0 mg/m 2/dan in bi bilo za odpravo neželenih učinkov potrebno dodatno zmanjšanje odmerka.
English: Metabolism accounts for <10% of the elimination of topotecan.
Slovenian: Presnova predstavlja < 10 % izločanja topotekana.
English: In patients presenting with fever, neutropenia and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Slovenian: Pri bolnikih z zvišano telesno temperaturo, nevtropenijo in ustreznim vzorcem trebušnih bolečin je treba pomisliti na možnost nevtropeničnega kolitisa.
English: Anti-tumour activity was demonstrated primarily in patients with neuroblastoma.
Slovenian: Protitumorsko delovanje topotekana je bilo dokazano predvsem pri bolnikih z nevroblastomom.
English: Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Slovenian: Drugi močno izraženi neželeni dogodki, ki so jih ocenili kot posledico ali možno posledico zdravljenja s topotekanom, so bili anoreksija (12 %), slabo počutje (3 %) in hiperbilirubinemija (1 %).
English: Overdoses have been reported in patients being treated with intravenous topotecan (up to 10 fold of the recommended dose) and topotecan capsules (up to 5 fold of the recommended dose).
Slovenian: Poročali so o prevelikih odmerjanjih pri pacientih, ki so bili zdravljeni z intravenskim topotekanom (do 10-kratni priporočeni odmerek) in topotekan kapsulami (do 5-kratni priporočeni odmerek).
English: • Staff handling this medicinal product should wear adequate protective clothing including mask, goggles and gloves.
Slovenian: • Osebje, ki ravna s tem zdravilom, mora nositi ustrezno zaščitno obleko, vključno z masko, očali in rokavicami.
English: Median time to onset of severe neutropenia was nine days and the median duration was seven days.
Slovenian: Mediana vrednost časa do začetka hude nevtropenije je bila devet dni, mediana vrednost trajanja nevtropenije pa sedem dni.
English: Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to reduce the dose to maintain neutrophil counts.
Slovenian: Običajna onkološka praksa pri zdravljenju nevtropenije je bodisi kombiniranje topotekana z drugimi zdravili (npr. G-CSF) ali pa zadostno zmanjšanje odmerka, da se ohranja potrebno število nevtrofilcev.