FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a.
Slovenian: En napolnjeni injekcijski peresnik z 0,5 ml raztopine vsebuje 135 mikrogramov peginterferona alfa-2a.
English: Pegasys Dose Modification
Slovenian: Prilagajanje odmerka zdravila Pegasys
English: Sarcoidosis, thyroiditis
Slovenian: Brez ciroze in s cirozo
English: Diarrhoea*, nausea*, abdominal pain*
Slovenian: Bolezni prebavil driska*, navzea*,
English: Polska
Slovenian: Nemčija
English: NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection Peginterferon alfa-2a
Slovenian: Navodilo za uporabo Pegasys 180 mikrogramov raztopina za injiciranje peginterferon alfa-2a
English: The sustained viral response achieved with 16 weeks of treatment and with 24 weeks of treatment was also examined in a retrospective subgroup analysis of patients who were HCV RNA negative by week 4 and had a LVL at baseline (see Table 17).
Slovenian: V retrospektivni analizi podskupine bolnikov, ki so bili HCV RNA negativni do 4. tedna in so imeli pred začetkom zdravljenja nizko virusno breme, so preučili tudi trajni virološki odziv, dosežen s 16
English: Digestive system disorders: Gastrointestinal bleeding Liver disorders: Poor functioning of the liver
Slovenian: Bolezni jeter: slabo delovanje jeter.
English: Ask your doctor, hospital or pharmacist for an appropriate container.
Slovenian: Primeren vsebnik lahko dobite pri svojem zdravniku, farmacevtu ali v bolnišnici.
English: Pegasys 90 micrograms solution for injection in pre-filled syringe The syringe contains graduation marks corresponding to 90 micrograms (mcg), 65 mcg, 45 mcg, 30 mcg, 20 mcg and 10 mcg.
Slovenian: Injekcijska brizga vsebuje oznake, ki ustrezajo 90 mikrogramom (mcg ali µg), 65 µg, 45 µg, 30 µg,
English: Genotype 1 RVR Low viral load High viral load Genotype 1 non RVR
Slovenian: Genotip 1, hiter virološki odziv nizko virusno breme visoko virusno breme
English: P=0.0006 P=0.11 P=0.002
Slovenian: p = 0,002
English: Mania, bipolar disorders, homicidal ideation
Slovenian: psihotične motnje manija, bipolarna motnja razpoloženja,
English: Hepatic impairment
Slovenian: - brez srčnega obolenja
English: Abdominal pain upper, stomatitis, nausea, aphthous stomatitis, oral disorder
Slovenian: stomatitis, navzea, aftozni stomatitis, bolezen ustne votline
English: Digestive system disorders: Diarrhoea, nausea, abdominal pain Skin disorders: Loss of hair, and skin reactions (including itching, dermatitis and dry skin) Muscle and bone disorders: Pain in joints and muscles General disorders: Fever, weakness, tiredness, shaking, chills, pain, injection site irritation and irritability (getting easily upset)
Slovenian: Splošne težave: zvišana telesna temperatura, slabotnost, utrujenost, tresenje, mrazenje, bolečina, vnetje na mestu injiciranja in razdražljivost (hitro se vznemirite).
English: Keep the pre-filled syringe in the outer carton in order to protect from light
Slovenian: Ne zamrzujte Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
English: Shortening the treatment duration in patients with genotype 1 and high viral load (HVL) (>800, 000 IU/ml) at baseline who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24 should be considered with even more caution since the limited data available suggest that this may significantly negatively impact the sustained virologic response.
Slovenian: Hiter virološki odziv = nemerljiva koncentracija HCV RNA v tednu 4 in nemerljiva koncentracija HCV RNA v tednu 24 Čeprav so podatki omejeni, kažejo na to, da je skrajšanje zdravljenja na 24 tednov lahko povezano z večjim tveganjem za ponovitev bolezni (glejte preglednico 16).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a.
Slovenian: En napolnjeni injekcijski peresnik z 0,5 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 135 µg PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA- 1 x 135 µg NAPOLNJENA INJEKCIJSKA BRIZGA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg PRE-FILLED PEN
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 1 x 180 µg NAPOLNJENI INJEKCIJSKI PERESNIK
English: ● To remove air bubbles from the syringe, hold the syringe with the needle pointing up.
Slovenian: ● Injekcijsko brizgo držite pokončno, igla naj bo obrnjena navzgor, da boste lahko odstranili zračne mehurčke.
English: Very common side effects with the combination of Pegasys and ribavirin (may affect more than 1 in 10 people) are:
Slovenian: Pogosti neželeni učinki pri kombiniranem zdravljenju zdravila Pegasys in ribavirina (pojavijo se lahko pri največ 1 od 10 bolnikov) so:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 1 ml solution contains 180 micrograms peginterferon alfa-2a.
Slovenian: Ena viala z 1 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a.
English: Suicide, psychotic disorder
Slovenian: zmedenostjo in spremembami duševnega stanja.
English: Eye disorders
Slovenian: očesni pruritis
English: Genotype 1 (N= 569)
Slovenian: Genotip A (n = 9)
English: ● a vial of Pegasys solution for injection Not included in the pack:
Slovenian: Izpostavljenost zdravilu Pegasys je bila v raziskavah,
English: Genotype 4 non RVR
Slovenian: Genotip 4, hiter virološki odziv
English: 135 or 180 micrograms peginterferon alfa-2a.
Slovenian: Pegasys 180 μg injekcija peginterferon alfa-2a s.c.
English: Pegasys dosing
Slovenian: Pegasys.
English: Sepsis
Slovenian: Stevens
English: 6 pre-filled syringes + 6 injection needles 135 micrograms/0.5 ml
Slovenian: raztopina za injiciranje 12 napolnjenih injekcijskih peresnikov 135 mikrogramov/0,5 ml
English: Back pain, pain in extremity
Slovenian: hematom na mestu vboda, bolečina
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 135 µg PRE-FILLED PEN
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA- 1 x 135 µg NAPOLNJENI INJEKCIJSKI PERESNIK
English: Assessment
Slovenian: Odmerjanje
English: Roche a/s c/o Icepharma hf Simi: +354 540 8000
Slovenian: Ísland Roche a/s c/o Icepharma hf
English: 6 pre-filled syringes + 6 injection needles 180 micrograms/0.5 ml
Slovenian: raztopina za injiciranje 12 napolnjenih injekcijskih peresnikov 180 mikrogramov/0,5 ml
English: Pegasys must be used with caution in patients with psoriasis, and in cases of onset or worsening of psoriatic lesions, discontinuation of therapy should be considered.
Slovenian: Pri bolnikih s psoriazo moramo zdravilo Pegasys uporabljati previdno.
English: NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Slovenian: Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi peginterferon alfa-2a
English: Genotype 1 RVR Low viral load High viral load Genotype 4 RVR
Slovenian: ≥ 2 log10 znižanje HCV RNA < 2 log10 znižanje HCV RNA
English: How to store Pegasys
Slovenian: Shranjevanje zdravila Pegasys
English: 3 x 200 mg tablets A.M. 3 x 200 mg tablets P.M.
Slovenian: 3 x 200-mg tablete zvečer
English: Cerebral ischaemia
Slovenian: Roche Austria GmbH
English: Vision blurred, eye pain, eye inflammation, xerophthalmia
Slovenian: kseroftalmija krvavitev mrežnice očesna nevropatija, edem papile,
English: -10.6% [-15.5% ; -0.06%] P<0.0001
Slovenian: Genotip 2 ali 3 65 % (443/679) 76 % (478/630) -10,6 % [-15,5 %;
English: Digestive system disorders: Stomach ulcer, inflammation of the pancreas Liver disorders: Liver failure, bile duct inflammation, fatty liver Muscle and bone disorders: Inflammation of the muscles Kidney disorders: Kidney failure
Slovenian: Bolezni mišično-skeletnega sistema: bolečina v hrbtu, vnetje sklepov, mišična oslabelost, bolečina v kosteh, bolečina v vratu, bolečina v mišicah, mišični krči.
English: Vials 3 years.
Slovenian: Viale 3 leta.
English: In some cases you may need a blood transfusion.
Slovenian: V nekaterih primerih je lahko potrebna transfuzija.
English: - Serious blood infection, which can be fatal.
Slovenian: - Resna okužba krvi, ki je lahko usodna.
English: The following information is intended for healthcare professionals only:
Slovenian: INFORMACIJE NAMENJENE SAMO ZDRAVSTVENEMU OSEBJU :
English: Table 2 Study results Study GOG-0179
Slovenian: Preglednica 2: Rezultati študije GOG-0179
English: If you are or think you might be pregnant, tell your doctor immediately.
Slovenian: Če ste noseči ali mislite, da bi lahko bili noseči, morate to nemudoma povedati svojemu zdravniku.
English: Reactions have been mild and have not generally required specific therapy
Slovenian: Reakcije so bile blage in praviloma niso zahtevale specifičnega zdravljenja.
English: If severe it may cause breathing difficulties.
Slovenian: Če je huda, lahko povzroči težave z dihanjem.
English: This treatment cycle will normally be repeated every three weeks.
Slovenian: Ta ciklus zdravljenja se po navadi ponavlja na tri tedne.
English: feet and throat.
Slovenian: stopalih in žrelu.
English: Mean half-life increased from 1.9 hours to 4.9 hours.
Slovenian: Srednja razpolovna doba se je z 1,9 ure podaljšala na 4,9 ur.
English: Talk to your doctor for advice on how to minimize the risk of bleeding.
Slovenian: Z zdravnikom se posvetujte, kako čim bolj zmanjšati tveganje krvavitev.
English: See section 6.6.
Slovenian: Glejte poglavje 6.6.
English: Tell you doctor if you think any of these could apply to you.
Slovenian: Zdravniku morate povedati, če menite, da kaj od tega velja za vas.
English: Extravasation has been reported very rarely.
Slovenian: Ekstravazacija je bila opisana zelo redko.
English: - Infections.
Slovenian: - Okužbe.
English: Volume of distribution was slightly decreased and thus half-life only increased by 14 %.
Slovenian: Volumen porazdelitve je bil malo manjši, zato se je razpolovna doba podaljšala le za 14%.
English: However there are insufficient data available to make a dose recommendation for this patient group.
Slovenian: Vseeno za sedaj nimamo na voljo zadostne količine podatkov, da bi priporočili odmerek za to skupino bolnikov.
English: This can lead to severe bleeding from relatively small injuries such as a small cut.
Slovenian: Posledica so lahko hude krvavitve iz razmeroma majhnih poškodb, npr. majhnih ureznin.
English: Always wash hands after removing gloves.
Slovenian: Potem, ko snamete rokavice, si vedno umijte roke.
English: - Itching (pruritus).
Slovenian: - Srbenje (pruritus).
English: Date of latest renewal: 6 June 2014
Slovenian: Datum prve odobritve: 24 julij 2009 Datum zadnjega podaljšanja: 6 junij 2014
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Slovenian: Pri tem morate upoštevati običajne postopke za ustrezno ravnanje z zdravili proti raku in njihovo odstranjevanje, in sicer:
English: Use in children and adolescents The experience in children and adolescents is limited and treatment is therefore not recommended.
Slovenian: Uporaba pri otrocih in mladostnikih Izkušenj pri otrocih in mladostnikih je malo, zato zdravljenje s tem zdravilom ni priporočljivo.
English: If you experience this, do not drive or use machines.
Slovenian: Če se vam pojavita, ne upravljajte vozil in strojev.
English: Liquid waste may be flushed with large amounts of water.
Slovenian: Tekoče odpadke je mogoče sprati z veliko količino vode.
English: 11 Ion Mihalache Blvd. 011171 Bucharest Romania
Slovenian: 11 Ion Mihalache Blvd 011171 Bukarešta Romunija
English: Topotecan also had a high volume of distribution, about 132 l, (SD 57) and a relatively short half-life of 2-3 hours.
Slovenian: Topotekan ima tudi velik volumen porazdelitve, približno 132 l (SD 57), in sorazmerno kratko razpolovno dobo, 2-3 ure.
English: Adverse reactions are listed below, by system organ class and absolute frequency (all reported events).
Slovenian: V nadaljevanju navajamo neželene učinke, razvrščene v razrede po organskih sistemih in po absolutni pogostnosti (vsi dogodki, o katerih so poročali).
English: The pharmacokinetics of topotecan given as a 30-minute infusion for 5 days were evaluated in two studies.
Slovenian: Farmakokinetika topotekana, ki so ga dajali v obliki 30-minutne infuzije 5 dni, je bila ovrednotena v dveh študijah.
English: This concentrate (1 mg/ml) must be diluted prior to administration.
Slovenian: Ta koncentrat (1 mg/ml) je treba pred uporabo razredčiti.
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), including isolated reports and not known (cannot be estimated from the available data).
Slovenian: Pogostnost je definirana z izrazi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < /1.000) in zelo redki (< 1/10.000), vključno s posameznimi primeri in ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
English: The doctor will evaluate your general health during the treatment and you should tell him/her in case you have fever, infection or are in some ways feeling unwell.
Slovenian: Zdravnik bo spremljal vaše splošno zdravstveno stanje med zdravljenjem in povedati mu morate, če se vam pojavi zvišana telesna temperatura, okužba ali se kako drugače slabo počutite.
English: It must be reconstituted and further diluted before use (see section 6.6).
Slovenian: Pred uporabo ga je potrebno rekonstruirati in nato še nadalje redčiti (glejte poglavje 6.6).
English: Do not use this medicine after the expiry date which is stated on the vial and carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: 11 Ion Mihalache Blvd Bucharest
Slovenian: 11 Ion Mihalache Blvd Bukarešta
English: The incidence of side effects is more frequent in patients who are in poor general health.
Slovenian: Neželeni učinki so pogostejši pri bolnikih, ki imajo slabo splošno zdravstveno stanje.
English: This treatment schedule is repeated every 21 days for six courses or until progressive disease.
Slovenian: Takšna shema zdravljenja se ponavlja vsakih 21 dni, šest ciklov ali dokler je bolezen v progresiji.
English: All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Slovenian: Vso opremo za dajanje zdravila ali čiščenje, vključno z rokavicami, je treba dati v vreče za odlaganje zelo tveganih odpadkov za upepelitev pri visoki temperaturi.
English: Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.
Slovenian: Čeprav ni znano, ali se topotekan pri človeku izloča v materinem mleku, je treba dojenje na začetku zdravljenja prekiniti.
English: - Hair loss.
Slovenian: - Izpadanje las.
English: Patients who are concerned about their fertility should ask their doctor for counselling on fertility and family planning options prior to starting treatment.
Slovenian: Bolniki, ki so zaskrbljeni glede svoje plodnosti naj se o tem in o načrtovanju družine pred začetkom zdravljenja posvetujejo s svojim zdravnikom.
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Slovenian: Nadaljnje ravnanje mora biti klinično indicirano ali priporočeno s strani nacionalnega centra za zastrupitve.
English: Other medicines and Topotecan Actavis Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Topotekan Actavis Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: Topotecan Actavis is available in cartons containing 1 vial and 5 vials.
Slovenian: Topotekan Actavis je na voljo v škatlah, ki vsebujejo 1 ali 5 vial.
English: Then seek medical evaluation by a physician.
Slovenian: Potem je potreben pregled pri zdravniku.
English: This increase is considered unlikely to be of clinical relevance.
Slovenian: Verjetnost, da bi to povečanje imelo klinični pomen je majhna.
English: They may require hospitalisation and could even be life-threatening.
Slovenian: Potreben je lahko sprejem v bolnišnico, ti učinki pa so lahko celo smrtno nevarni.
English: Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to dose reduce to maintain neutrophil counts.
Slovenian: Standardna onkološka praksa za obvladovanje nevtropenije je bodisi uporaba topotekana z drugimi zdravili (npr. G-CSF) bodisi zmanjšanje odmerka za ohranitev števila nevtrofilcev.
English: If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Slovenian: Če ga bolniki dobro prenašajo, smemo z zdravljenjem nadaljevati, dokler je bolezen v progresiji (glejte poglavji 4.8 in 5.1).
English: Antitumour activity was demonstrated primarily in patients with neuroblastoma.
Slovenian: Protitumorsko delovanje je bilo dokazano predvsem pri bolnikih z nevroblastomom.
English: A doctor or nurse will give you the reconstituted and diluted Topotecan Actavis solution as an infusion (drip), usually into your arm, over about 30 minutes.
Slovenian: Zdravnik ali medicinska sestra vam bosta dala pripravljeno in razredčeno raztopino zdravila Topotekan Actavis v infuziji (kapalni), po navadi v roko; infuzija bo trajala približno 30 minut.
English: Each vial is sheathed in a protective sleeve.
Slovenian: Vsaka viala je obdana z zaščitno oblogo.
English: Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic substances and/or colony stimulating factors.
Slovenian: Med osnovnimi dejavniki tveganja so anamneza ILD, pljučna fibroza, pljučni rak, izpostavljenost prsnega koša obsevanju in uporaba pnevmotoksičnih snovi in/ali kolonije stimulirajočih faktorjev.
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 dejavniki, med drugim starost, telesna masa in ascites, niso značilno vplivali na očistek celotnega topotekana (aktivne in neaktivne oblike).
English: The median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Slovenian: Srednji čas preživetja je bil 30,3 tednov (95% interval zaupanja: 27,6; 33,4).
English: Your dose of Topotecan Actavis will depend on: - the disease being treated, - your body surface area (m - the results of blood tests carried out before and during treatment, - how well you tolerate treatment.
Slovenian: Odmerek zdravila Topotekan Actavis bo odvisen od: - zdravljene bolezni, - vaše telesne površine (m - izvidov preiskav krvi, opravljenih pred zdravljenjem in med njim, - tega, kako dobro prenašate zdravljenje.
English: The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0 %.
Slovenian: Topotekan-O-glukuronid in N-desmetil topotekan-O-glukuronid sta v urinu v manj kot 2,0%.
English: In clinical trials, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Slovenian: Med kliničnimi preskušanji so o izpuščaju poročali pri 4% bolnikov in o pruritusu pri 1,5% bolnikov.
English: Adequate protective disposable gloves, goggles, gown and mask should be worn.
Slovenian: Osebje mora nositi ustrezne zaščitne rokavice, očala, haljo in masko.
English: Abnormal low number of neutrophil granulocytes (a type of white blood cell) in the blood, with or without fever.
Slovenian: Nenormalno majhno število nevtrofilnih granulocitov (vrste belih krvnih celic) v krvi, z zvišano telesno temperaturo ali brez nje.
English: - Decrease in the number of all blood cells (pancytopenia) - Feeling unwell.
Slovenian: - Zmanjšano število vseh krvnih celic (pancitopenija) - Slabo počutje.
English: Precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes.
Slovenian: Potrebni so ustrezni previdnostni ukrepi, da bi preprečili naključen stik zdravila z očmi.
English: Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Slovenian: Anemija: Zmerna do huda (Hb ≤ 8,0 g/dl) pri 37% bolnikov (14% ciklov zdravljenja).
English: Storage after reconstitution and dilution
Slovenian: Shranjevanje po pripravi in razredčenju
English: Topotecan Actavis should not be used in pregnant women, unless clearly necessary.
Slovenian: Zdravila Topotekan Actavis se pri nosečnicah ne sme uporabiti, če ni nujno potrebno.
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% ciklov zdravljenja) prišlo do sepse (glejte poglavje 4.4).
English: Metabolism accounts for < 10 % of the elimination of topotecan.
Slovenian: Presnova predstavlja < 10% izločanja topotekana.
English: This should be taken into account, when prescribing topotecan e.g. in case patients at increased risk of tumour bleeds are considered for therapy.
Slovenian: To je treba upoštevati pri predpisovanju topotekana, npr. pri bolnikih, pri katerih obstaja večje tveganje za pojav krvavitve tumorja.
English: infection
Slovenian: okužba
English: - Decrese in number of circulating white blood cells (leucotyes) in the blood.
Slovenian: - Zmanjšanje števila krožečih belih krvnih celic (levkocitov) v krvi.
English: Topotecan does not inhibit human P450 enzymes (see section 5.2).
Slovenian: Topotekan ne zavira encimov humanega citokroma P450 (glejte poglavje 5.2).
English: Overall, the N-desmethyl metabolite contributed a mean of less than 7 % (range 4-9 %) of the total medicinal product related material accounted for in the urine and faeces.
Slovenian: Presnovek N-desmetil predstavlja v povprečju manj kot 7% (razpon 4-9%) skupnih z zdravilom povezanih snovi prisotnih v urinu in blatu.
English: The powder must be dissolved, and the resulting concentrate further diluted before administration.
Slovenian: Prašek je treba raztopiti in dobljeni koncentrat pred uporabo dodatno razredčiti.
English: Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients.
Slovenian: Popolna ali izrazita alopecija se je pojavila pri 30% bolnikov, delna pa pri 15% bolnikov.
English: However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Slovenian: A tako kot druga citotoksična zdravila je tudi topotekan genotoksičen in vpliva na plodnost (tudi na moško plodnost) ni mogoče izključiti.
English: The preparation should be performed in a designated area under aseptic conditions.
Slovenian: Zdravilo je treba pripraviti v prostoru, ki je temu namenjen, in v aseptičnih pogojih.
English: The experience in children is limited, therefore no recommendation for treatment of paediatric patients with Topotecan Actavis can be given (see sections 5.1 and 5.2).
Slovenian: Izkušnje pri otrocih so nezadostne, zato ni mogoče dati priporočil za zdravljenje pediatričnih bolnikov z zdravilom Topotekan Actavis (glejte poglavji 5.1 in 5.2).
English: Contraception in males and females
Slovenian: Kontracepcijska zaščita pri moških in ženskah
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 30%, volumen porazdelitve pa se ni bistveno spremenil.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX17.
Slovenian: Farmakoterapevtska skupina: Druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX17
English: As with all cytotoxic chemotherapy, effective contraceptive methods must be advised when either partner is treated with topotecan.
Slovenian: Kot velja za vsako citotoksično kemoterapijo, je treba svetovati uporabo učinkovite kontracepcijske zaščite, če kateri od partnerjev dobiva terapijo s topotekanom.