FrancophonIA/ELRC3.0 huggingface dataset:
English: Effective contraception methods should be used to avoid becoming pregnant/fathering a child while on treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju kako bi izbjegle trudnoću tijekom liječenja.
English: Precautions to be taken before handling or administering the medicinal product Reconstitution and dilution of the medicinal product must be performed by trained personnel.
Croatian: Mjere opreza koje treba poduzeti prije rukovanja lijekom ili primjene lijeka Rekonstituciju i razrjeđivanje lijeka mora provoditi educirano osoblje.
English: Adequate care and precautions should be taken in the disposal of items (syringes, needles etc) used to reconstitute and/or dilute cytotoxic medicinal products.
Croatian: Potrebno je poduzeti odgovarajuće mjere opreza pri zbrinjavanju predmeta (štrcaljki, igala i dr.) korištenih za rekonstituciju i/ili razrjeđivanje citotoksičnih lijekova.
English: The usual dose is 0.75 mg per m of body surface area once daily for 3 days.
Croatian: Uobičajena doza je 0,75 mg po m2 tjelesne površine jedanput na dan tijekom 3 dana.
English: The powder must be dissolved, and the resulting concentrate further diluted before administration.
Croatian: Prije primjene prašak se mora najprije otopiti, a nastali koncentrat dalje razrijediti.
English: Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
Croatian: Sažeti prikaz preživljenja, stope odgovora i vremena do progresije bolesti u bolesnika s karcinomom pluća malih stanica liječenih peroralnim ili intravenskim pripravkom topotekana
English: Oral topotecan plus BSC group had a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p = 0.0104).
Croatian: Skupina koja je primala topotekan peroralno uz BSC imala je statistički značajno poboljšanje u ukupnom preživljenju u odnosu na skupinu koja je liječena samo BSC-om (log-rank p=0,0104).
English: For intravenous use as infusion, after reconstitution and dilution.
Croatian: Za infuziju u venu, nakon rekonstitucije i razrjeđivanja.
English: Initial dose The recommended dose of topotecan is 1.5 mg/m body surface area/day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three week interval between the start of each course.
Croatian: Početna doza Preporučena doza topotekana je 1,5 mg/m2 tjelesne površine/dan, primijenjena intravenskom infuzijom u trajanju od 30 minuta dnevno tijekom pet uzastopnih dana s trotjednim intervalima između započinjanja svakog ciklusa.
English: Actavis Deutschland GmbH & Co. KG Telefon: +49 (0)89 558909 0
Croatian: KG Telefon: +49 (0)89 558909 0
English: Add 19 ml to give 20 ml 4 ml of 1 mg/ml topotecan solution Add 156 ml to give 160 ml Add 76 ml to give 80 ml
Croatian: 4 ml otopine topotekana od 1 mg/ml Dodajte 156 ml da biste dobili 160 ml
English: A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/dl) were given intravenous topotecan at 1.5 mg/m for five days every three weeks.
Croatian: Mali broj bolesnika s oštećenjem jetrene funkcije (vrijednosti bilirubina u serumu između 1,5 i 10 mg/dl) primio je topotekan intravenski u dozi od 1,5 mg/m² tijekom pet dana svaka tri tjedna.
English: Plasma clearance in patients with hepatic impairment (serum bilirubin between 1.5 and 10 mg/dl) decreased to about 67 % when compared with a control group of patients.
Croatian: Klirens plazme u bolesnika s oštećenjem jetre (vrijednosti bilirubina u serumu između 1,5 i 10 mg/dl) smanjen je na oko 67% u usporedbi s kontrolnom skupinom bolesnika.
English: Mild abdominal pain was also reported amongst 4 % of patients.
Croatian: Prijavljena je i pojava blage abdominalne boli u 4% bolesnika.
English: In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 1.5 mg/dl.
Croatian: U kliničkim ispitivanjima kombinacije topotekana i cisplatina u liječenju karcinoma vrata maternice terapija je započeta samo u bolesnica s vrijednošću kreatinina u serumu 1,5 mg/dl.
English: Not known:
Croatian: Često: Nepoznato:
English: Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Croatian: U farmakokinetičkom ispitivanju pedijatrijskih bolesnika s refraktornim solidnim tumorima, ustanovljena je maksimalna podnošljiva doza od 2,0 mg/m2/dan uz primjenu G-CSF, odnosno 1,4 mg/m2/dan bez primjene GCSF (vidjeti dio 5.2) na temelju toksičnosti u obliku mijelosupresije koja je bila ograničavajuća za dozu.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf.
Croatian: IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Actavis Group PTC ehf.
English: Topotecan is not recommended to be used in these patient groups.
Croatian: U ovih skupina bolesnika se ne preporučuje primjena topotekana.
English: For cervical cancer, it will be used together with another anticancer medicines containing cisplatin.
Croatian: U liječenju raka vrata maternice ovaj lijek će se kombinirati s drugim lijekovima protiv raka koji sadrže cisplatin.
English: Topotecan Actavis 1 mg vials must be reconstituted with 1.1 ml water for injections.
Croatian: Bočice lijeka Topotecan Actavis 1 mg moraju se rekonstituirati s 1,1 ml vode za injekcije.
English: Topotecan is contraindicated in patients who - have a history of severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - are breast-feeding (see section 4.6) - already have severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 10
Croatian: Primjena topotekana je kontraindicirana u: bolesnika s anamnezom jake preosjetljivosti na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 bolesnica koje doje (vidjeti dio 4.6) bolesnika s teškom depresijom koštane srži prije započinjanja prvog ciklusa, što se odnosi na početni broj neutrofila < 1,5 x 109/l i/ili broj trombocita < 100 x 109/l.
English: Patients without prior cisplatin chemoradiotherapy Cisplatin
Croatian: Bolesnice bez prethodne kemoradioterapije cisplatinom cisplatin topotekan/cisplatin
English: Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose.
Croatian: Cisplatin se primjenjuje prvog dana u obliku intravenske infuzije u dozi od 50 mg/m2/dan i to nakon doze topotekana.
English: Topotecan is supplied as a powder for concentrate for solution for infusion.
Croatian: Topotekan je dostupan kao prašak za koncentrat za otopinu za infuziju.
English: Your dose of Topotecan Actavis may need to be adjusted.
Croatian: Možda će Vam biti potrebna prilagodba doze lijeka Topotecan Actavis.
English: Type I colourless glass vial (8 ml), with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 4 mg topotecan.
Croatian: Bezbojna bočica (8 ml) od stakla tipa I, zatvorena sivim bromobutilnim čepom i aluminijskim pokrovom s plastičnim flip-off zatvaračem koja sadrži 4 mg topotekana.
English: After reconstitution, 1 ml concentrate contains 1 mg topotecan.
Croatian: Nakon rekonstitucije, 1 ml koncentrata sadrži 1 mg topotekana.
English: Topotecan Actavis 4 mg vials must be reconstituted with 4 ml water for injections.
Croatian: Bočice lijeka Topotecan Actavis 4 mg moraju se rekonstituirati s 4 ml vode za injekcije.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
English: Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Croatian: Prijavljeni su slučajevi intersticijske bolesti pluća (IBP) vezani uz primjenu topotekana, od kojih su neki bili fatalni (vidjeti dio 4.8).
English: Severe (grade 3 or 4) fatigue and asthenia incidence was 3 and 3 % respectively.
Croatian: Incidencija pojave teškog (stupanj 3 ili 4) umora i astenije iznosila je oko 3%.
English: - The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
Croatian: Drugi sastojci su: manitol (E421), tartaratna kiselina (E334), kloridna kiselina (E507) i natrijev hidroksid.
English: Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C, in normal light conditions and 24 hours at 2°C to 8°C, protected from light.
Croatian: Kemijska i fizikalna stabilnost koncentrata je dokazana tijekom 24 sata na temperaturi od 25 ± 2°C i u normalnim svjetlosnim uvjetima te tijekom 24 sata na temperaturi od 2°C do 8°C, zaštićeno od svjetlosti.
English: Additional adverse events were seen when topotecan was given in combination with cisplatin, however, these events were seen with cisplatin monotherapy and not attributable to topotecan.
Croatian: Prilikom primjene topotekana u kombinaciji s cisplatinom zabilježeni su dodatni štetni događaji, međutim ti štetni događaji su zabilježeni i u monoterapiji cisplatinom i nisu povezani s topotekanom.
English: 5.2 mg/m in children (n = 8), adolescents (n = 3), and young adults (n = 3) with leukaemia.
Croatian: U drugom ispitivanju raspon doza bio je 2,0 mg/m2 do 5,2 mg/m2 u djece (n=8), adolescenata (n=3) i mlađih odraslih osoba (n=3) s leukemijom.
English: 11 Ion Mihalache Blvd Bucharest
Croatian: S.C. Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd Bukurešt
English: nausea, vomiting and diarrhoea (all of which may be severe)
Croatian: mučnina, povraćanje i proljev (svi mogu biti teški) konstipacija bol u abdomenu2
English: A phase III trial (study 478) compared oral topotecan plus Best Supportive Care (BSC) (n = 71) with BSC alone (n = 70) in patients who had relapsed following first line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan + BSC, 90 days for BSC and for whom retreatment with intravenous chemotherapy was not considered appropriate.
Croatian: Best Supportive Care) (n=71) s primjenom samog BSC-a (n=70) u bolesnika s recidivom karcinoma nakon prve linije liječenja (medijan vremena do progresije od prve linije liječenja [TTP; engl. time to progression] iznosio je 84 dana za oralni topotekan + BSC, a 90 dana za BSC) i u bolesnika koji nisu bili kandidati za ponovljenu intravensku kemoterapiju.
English: Rare side effects (may affect up to 1 in 1,000 people) - Swelling caused by fluid build-up (angioedema) e.g. around the eyes and lips as well as hands,
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) teške alergijske (anafilaktičke) reakcije. oticanje uzrokovano nakupljanjem tekućine (angioedem), npr. oko očiju i usana, ali i ruku, stopala i grla.
English: 9/l) for seven days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/m 2/day to 1.25 mg/m 2/day (or subsequently down to 1.0 mg/m 2/day if necessary).
Croatian: Ukoliko se u bolesnika s teškom neutropenijom (broj neutrofila <0,5 x 109/l) koja traje sedam dana ili dulje, ili s teškom neutropenijom praćenom vrućicom ili infekcijom, ili u onih kojima je zbog neutropenije liječenje odgođeno, izabere smanjenje doze, istu je potrebno smanjiti za 0,25 mg/m2/dan do 1,25 mg/m2/dan (ukoliko je potrebno, moguće je daljnje smanjenje doze na 1,0 mg/m2/dan).
English: Patients who are concerned about their fertility should ask their doctor for counselling on fertility and family planning options prior to starting treatment.
Croatian: Muški bolesnici koji žele postati očevi moraju se savjetovati sa svojim liječnikom o planiranju obitelji ili liječenju.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/536/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/536/001
English: Type I colourless glass vial (5 ml) with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 1 mg topotecan.
Croatian: Bezbojna bočica (5 ml) od stakla tipa I, zatvorena sivim bromobutilnim čepom i aluminijskim pokrovom s plastičnim flip-off zatvaračem koja sadrži 1 mg topotekana.
English: Mannitol (E421) Tartaric acid (E334) Sodium hydroxide Hydrochloric acid (E507)
Croatian: 6.1 Popis pomoćnih tvari manitol (E421) tartaratna kiselina (E334) natrijev hidroksid kloridna kiselina (E507)
English: - Lung inflammation (rare; may affect up to 1 in 1,000 people), with signs such as: - difficulty in breathing - cough - fever The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs, see also section 2 “Warnings and precautions”.This condition can be fatal.
Croatian: Rizik da se u Vas razvije ovo teško stanje (intersticijska plućna bolest) je povećan ako već imate probleme s plućima ili ste liječeni zračenjem ili ako ste prije uzimali lijekove koji mogu oštetiti pluća; pogledajte također dio 2 „Upozorenja i mjere opreza“.
English: Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Croatian: Kod bolesnica koje su prethodno bile izložene cisplatinu potrebno je dulje razdoblje bez liječenja kako bi liječenje kombinacijom bilo opravdano (vidjeti dio
English: Initial dose The recommended dose of topotecan is 0.75 mg/m2/day administered as 30 minute intravenous infusion daily on days 1, 2 and 3.
Croatian: Preporučena doza topotekana je 0,75 mg/m2/dan, primijenjena intravenskom infuzijom u trajanju od 30 minuta dnevno prvog, drugog i trećeg dana ciklusa.
English: - Decrese in number of circulating white blood cells (leucotyes) in the blood.
Croatian: U nekim slučajevima možda ćete trebati transfuziju krvi. smanjenje broja cirkulirajućih bijelih krvnih stanica (leukociti) u krvi.
English: malaise
Croatian: malaksalost
English: Actavis treatment is combined with medicines containing cisplatin.
Croatian: U tom slučaju Topotecan Actavis se kombinira s lijekovima koji sadrže cisplatin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/536/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/536/002
English: An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Croatian: U urinu su pronađeni i metabolit O-glukuronidacije topotekana i N-desmetil topotekan.
English: Contains mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
Croatian: Sadrži: manitol (E421), tartaratnu kiselinu (E334), kloridnu kiselinu (E507) i natrijev hidroksid.
English: Date of latest renewal: 6 June 2014
Croatian: Datum posljednje obnove:
English: Patients with prior cisplatin chemoradiotherapy Cisplatin
Croatian: Bolesnice s prethodnom kemoradioterapijom cisplatinom cisplatin topotekan/cisplatin
English: Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions.
Croatian: Kemijska i fizikalna stabilnost otopine dobivene nakon razrjeđenja koncentrata u otopini natrijevog klorida 9 mg/ml (0,9%) za injekciju ili u otopini glukoze 50 mg/ml (5%) za infuziju je dokazana za 4 sata na temperaturi od 25 ± 2°C, u normalnim svjetlosnim uvjetima.
English: Packs:
Croatian: Pakiranja:
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.
Croatian: Uobičajena onkološka praksa zbrinjavanja neutropenije je ili primjena topotekana s drugim lijekovima (npr. G-CSF) ili smanjenje doze s ciljem održavanja primjerenog broja neutrofila.
English: The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of protein-associated DNA single-strand breaks.
Croatian: Posljedica inhibicije topoizomeraze-I topotekanom na staničnoj razini je indukcija cijepanja jednostrukog lanca DNK vezanog za proteine.
English: Topotecan Actavis contains the active substance topotecan which helps to kill tumour cells.
Croatian: Topotecan Actavis pomaže pri uništavanju tumorskih stanica.
English: Each vial contains 1 mg or 4 mg topotecan (as hydrochloride).
Croatian: Jedna bočica sadrži 1 mg ili 4 mg topotekana (u obliku topotekanklorida).
English: When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Croatian: U slučaju kombiniranog liječenja s cisplatinom potrebno je slijediti detaljne upute za propisivanje cisplatina.
English: 9/l) for seven days or more, or severe neutropenia associated with fever or infection or who have had treatment delayed due to neutropenia, the dose should be reduced by 20 % to 0.60 mg/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).
Croatian: Ukoliko se u bolesnika s teškom neutropenijom (broj neutrofila <0,5 x 109/l) u trajanju od sedam dana ili dulje, ili s teškom neutropenijom praćenom vrućicom ili infekcijom, ili u onih kojima je zbog neutropenije liječenje odgođeno, izabere smanjenje doze, istu je potrebno smanjiti u sljedećim ciklusima za 20%, na 0,60 mg/m2/dan (ukoliko je potrebno, moguće je daljnje smanjenje doze na 0,45 mg/m2/dan).
English: Small Cell Lung Carcinoma
Croatian: Recidiv karcinoma pluća malih stanica
English: The physico-chemical stability of the drug product solution obtained after dilution in solutions for infusion (NaCl 0.9 % and Glucose 5 %) has been demonstrated for 4 hours at room temperature, in normal lighting conditions, on samples reconstituted and stored for 12 hours and respectively 24 hours at 25
Croatian: Kemijska i fizikalna stabilnost otopine lijeka dobivene nakon razrjeđivanja u otopinama za infuziju (natrijev klorid 0,9% i glukoza 5%) je dokazana za 4 sata na sobnoj temperaturi, u normalnim svjetlosnim uvjetima na uzorcima koji su rekonstituirani i pohranjeni tijekom 12 sati, odnosno 24 sata na temperaturi od 25°C ± 2°C, a potom razrijeđeni.
English: An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma, and faeces.
Croatian: U urinu, plazmi i fecesu pronađen je jedan N-desmetil metabolit koji je pokazao sličnu ili manju aktivnost od ishodišnog spoja u testu koji koristi stanice (engl. cellbased assay).
English: Tel: +421 2 3255 3800
Croatian: Actavis s.r.o. Tel: +421 2 3255 3800
English: A reduction in topotecan clearance was observed.
Croatian: Uočen je smanjeni klirens topotekana.
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Croatian: Zabilježeni su slučajevi sepse zbog mijelosupresije, kao i smrtni ishodi zbog sepse kod bolesnika liječenih topotekanom (vidjeti dio 4.8).
English: 5 x 4 mg vial
Croatian: 5 bočica x 4 mg
English: Median (95 % C.I) Hazard ratio (95 % C.I.)
Croatian: Medijan (95% CI) Omjer hazarda (95% CI)
English: Tel: +43 (0)662 435 235 00
Croatian: Actavis GmbH Tel: + 43 (0)662 435 235 00
English: 5 x 1 mg vial
Croatian: 5 bočica x 1 mg
English: Fatalities due to neutropenic colitis have been reported in clinical trials with topotecan.
Croatian: U kliničkim ispitivanjima topotekana zabilježeni su slučajevi neutropeničnog kolitisa sa smrtnim ishodom.
English: The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan.
Croatian: Prozirni koncentrat je svijetložute boje i sadrži 1 mg topotekana po ml.
English: Small cell lung cancer The usual dose is 1.5 mg per m of body surface area once daily for 5 days.
Croatian: Uobičajena doza je 1,5 mg po m2 tjelesne površine jedanput na dan tijekom 5 dana.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg topotecan (as hydrochloride).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 1 mg topotekana (u obliku topotekanklorida).
English: 25 microgram/ml solution
Croatian: Volumen za otopinu od 25 mikrograma/ml
English: - Feeling sick (nausea), vomiting; diarrhoea; stomach pain; constipation.
Croatian: upala sluznice usne šupljine i probavnog trakta. vrućica. infekcije. ispadanje kose.
English: Topotecan Actavis 1 mg powder for concentrate for solution for infusion Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Croatian: Topotecan Actavis 1 mg prašak za koncentrat za otopinu za infuziju Topotecan Actavis 4 mg prašak za koncentrat za otopinu za infuziju topotekan
English: Cisplatin 50 mg/m d.1 + Topotecan 0,75 mg/ m dx3
Croatian: cisplatin 50 mg/m2 1. dan svakih 21 dan cisplatin 50 mg/m2 1. dan +
English: oC ± 2
Croatian: Tablica 2.
English: 9/l) during course 1 was seen in 55 % of the patients and with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Croatian: Neutropenija: teška neutropenija (broj neutrofila < 0,5 x 109/l) tijekom prvog ciklusa zabilježena je u 55% bolesnika, od kojih je 20% bolesnika imalo neutropeniju u trajanju sedam dana ili dulje, a tijekom čitavog liječenja u ukupno 77% bolesnika (39% ciklusa).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 4 mg topotecan (as hydrochloride).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 4 mg topotekana (u obliku topotekanklorida).
English: Metabolism and nutrition disorders Very common:
Croatian: Poremećaji metabolizma i prehrane
English: Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecaninduced neutropenia (see section 4.4).
Croatian: 2kao komplikacija neutropenije izazvane topotekanom zabilježen je neutropenični kolitis, uključujući neutropenični kolitis sa smrtnim ishodom (vidjeti dio 4.4).
English: The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan, as Topotecan Actavis 1 mg contains a 10 % overage of fill.
Croatian: Kako Topotecan Actavis 1 mg sadrži 10% suviška u punjenju, prozirni koncentrat je svijetložute boje i sadrži 1 mg topotekana po ml.
English: 1 x 1 mg vial
Croatian: 1 bočica x 1 mg
English: How to store Topotecan Actavis
Croatian: Kako čuvati Topotecan Actavis
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion is required to a final concentration of between 25 and 50 microgram/ml.
Croatian: Kako bi se dobila konačna koncentracija topotekana između 25 i 50 mikrograma/ml, potrebno je dodatno razrijediti odgovarajući volumen rekonstituirane otopine ili pomoću otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju ili pomoću otopine glukoze 50 mg/ml (5%) za infuziju.
English: Österreich Actavis GmbH
Croatian: България Актавис ЕАД
English: The prescribing information for cisplatin should be consulted for a full list of adverse events associated cisplatin use.
Croatian: Za cjeloviti popis štetnih događaja povezanih s liječenjem cisplatinom potrebno je proučiti upute za propisivanje cisplatina.
English: - Serious blood infection, which can be fatal.
Croatian: Ovo stanje može biti fatalno.
English: 1 x 4 mg vial
Croatian: 1 bočica x 4 mg
English: However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Croatian: Međutim, ukoliko su trajno prisutni umor i astenija, preporučuje se oprez prilikom vožnje i upravljanja strojevima.
English: How Topotecan Actavis is prepared
Croatian: Kako se priprema Topotecan Actavis
English: Tel: +386 51 615 015
Croatian: Apta Medica Internacional d.o.o. Tel: +386 51 615 015