FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of REYATAZ with glecaprevir/pibrentasvir is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3)
Croatian: Istodobna primjena lijeka REYATAZ s glekaprevir/pibrentasvirom kontraindicirana je jer postoji rizik povišenja vrijednosti ALTa zbog značajnog povećanja koncentracije glekaprevira i pibrentasvira u plazmi (vidjeti dio 4.3).
English: It is especially important to mention these: other medicines to treat HIV infection (e.g. indinavir, nevirapine and efavirenz) boceprevir and sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C) sildenafil, vardenafil, or tadalafil (used by men to treat impotence (erectile dysfunction)) if you are taking an oral contraceptive ("the Pill") with REYATAZ to prevent pregnancy, be sure to take it exactly as instructed by your doctor and not miss any doses any medicines used to treat diseases related to the acid in the stomach (e.g. antacids to be taken 1 hour before taking REYATAZ or 2 hours after taking REYATAZ, H2-blockers like famotidine and proton pump inhibitors like omeprazole) medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm (amiodarone, diltiazem, systemic lidocaine, verapamil) atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol) salmeterol (used to treat asthma) cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune system) certain antibiotics (rifabutin, clarithromycin) ketoconazole, itraconazole, and voriconazole (antifungals) warfarin (anticoagulant, used to reduce the blood clots) carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptics) irinotecan (used to treat cancer) sedative agents (e.g. midazolam administered by injection) buprenorphine (used to treat opioid addiction and pain).
Croatian: Osobito je važno da spomenete sljedeće: druge lijekove za liječenje HIV-infekcije (npr. indinavir, nevirapin i efavirenz) boceprevir i sofusbuvir/velpatasvir/voksilaprevir (koji se koriste u liječenju hepatitisa C) sildenafil, vardenafil ili tadalafil (uzimaju ga muškarci za liječenje impotencije (erektilna disfunkcija) ako uzimate oralnu kontracepciju ("pilule") s lijekom REYATAZ, za sprečavanje trudnoće, pazite da je uzimate točno prema uputama liječnika i da ne propustite niti jednu dozu bilo koje lijekove za liječenje bolesti povezanih s kiselinom u želucu (npr., antacide, koji se moraju uzeti barem 1 sat prije uzimanja lijeka REYATAZ, ili 2 sata nakon uzimanja lijeka REYATAZ, H2-blokatore kao famotidin ili inhibitore protonske pumpe kao omeprazol) lijekove za snižavanje krvnog tlaka, usporavanje rada srca ili ispravljanje srčanog ritma (amiodaron, diltiazem, sistemski lidokain, verapamil) atorvastatin, pravastatin i fluvastatin (primjenjuju se za snižavanje kolesterola u krvi) salmeterol (primjenjuje se za liječenje astme) ciklosporin, takrolimus i sirolimus (lijekovi za sniženje učinaka imunološkog sustava tijela) određene antibiotike (rifabutin, klaritromicin) ketokonazol, itrakonazol i vorikonazol (antimikotici) varfarin (antikoagulans, primjenjuje se za smanjenje zgrušavanja krvi) karbamazepin, fenitoin, fenobarbital, lamotrigin (antiepileptici) irinotekan (primjenjuje se u liječenju raka) sedative (npr. midazolam primijenjen injekcijom) buprenorfin (primjenjuje se za liječenje ovisnosti o opijatima i boli).
English: Famotidine 20 mg twice daily Atazanavir AUC ↓21% (↓34% ↓4%) * Atazanavir Cmax ↓21% (↓36% ↓4%) * Atazanavir Cmin ↓19% (↓37% ↑5%) *
Croatian: Atazanavir AUC ↓21% (↓34% ↓4%) * Atazanavir Cmax ↓21% (↓36% ↓4%) * Atazanavir Cmin ↓19% (↓37% ↑5%) *
English: REYATAZ 200 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Croatian: REYATAZ 200 mg tvrde kapsule isporučuju se i u blisterima u pakiranjima sa 60 kapsula.
English: s r.o.
Croatian: + ritonavir.
English: Co-administration of nevirapine with REYATAZ/ritonavir is not recommended (see section 4.4)
Croatian: Ne preporučuje se istovremena primjena nevirapina i lijeka REYATAZ/ritonavira (vidjeti dio 4.4)
English: REYATAZ 200 mg hard capsules
Croatian: REYATAZ 200 mg tvrde kapsule
English: Famotidine 40 mg twice daily Atazanavir AUC ↓24% (↓36% ↓11%)* Atazanavir Cmax ↓23% (↓36% ↓8%) * Atazanavir Cmin ↓25% (↓47% ↑7%) *
Croatian: Atazanavir AUC ↓24% (↓36% ↓11%)* Atazanavir Cmax ↓23% (↓36% ↓8%) * Atazanavir Cmin ↓25% (↓47% ↑7%) *
English: NAME OF THE MEDICINAL PRODUCT REYATAZ 150 mg hard capsules atazanavir
Croatian: NAZIV LIJEKA REYATAZ 150 mg tvrde kapsule atazanavir
English: Co-administration of nevirapine and REYATAZ is not recommended (see section 4.4)
Croatian: Ne preporučuje se istovremena primjena nevirapina i lijeka REYATAZ (vidjeti dio 4.4)
English: Co-administration of REYATAZ/ritonavir with alfuzosin is contraindicated (see section 4.3)
Croatian: Istovremena primjena alfuzosina i lijeka REYATAZ/ritonavira je kontraindicirana (vidjeti dio 4.3)
English: Opaque blue and white capsule printed with white and blue inks, with "BMS 100 mg" on one half and with "3623" on the other half.
Croatian: Neprozirna plava i bijela kapsula s otisnutim "BMS 100 mg" na jednoj polovici i "3623" na drugoj polovici plavom i bijelom tintom.
English: The co-administration of REYATAZ/ritonavir with stavudine is not expected to significantly alter the exposure of stavudine.
Croatian: Ne očekuje se da će istovremena primjena stavudina i lijeka REYATAZ/ritonavira značajno promijeniti izloženost stavudinu.
English: Serum concentrations of verapamil may be increased by REYATAZ due to CYP3A4 inhibition.
Croatian: REYATAZ može povisiti koncentracije verapamila u serumu zbog inhibicije enzima CYP3A4.
English: REYATAZ 100 mg hard capsules atazanavir
Croatian: REYATAZ 100 mg tvrde kapsule atazanavir
English: REYATAZ with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.4 and 5.2).
Croatian: Ne preporučuje se primjenjivati REYATAZ s ritonavirom u bolesnika na hemodijalizi (vidjeti dijelove 4.4 i 5.2).
English: REYATAZ 100 mg hard capsules are supplied in bottles of 60 capsules.
Croatian: REYATAZ 100 mg tvrde kapsule isporučuju se u bocama sa 60 kapsula.
English: Kidney stones have been reported in patients taking REYATAZ.
Croatian: U bolesnika koji uzimaju REYATAZ zabilježeni su bubrežni kamenci.
English: If you get any side effects talk to your doctor, or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, lurasidone, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (see section 4.5).
Croatian: Istovremena primjena s lijekovima koji su supstrati izoenzima CYP3A4 citokroma P450 i imaju uzak terapijski raspon (npr. kvetiapin, alfuzosin, astemizol, terfenadin, cisaprid, pimozid, kinidin, lurasidon, bepridil, triazolam, peroralno primijenjen midazolam (za mjere opreza kod parenteralno primijenjenog midazolama, vidjeti dio 4.5) i alkaloidi ergota, osobito ergotamin, dihidroergotamin, ergonovin, metilergonovin) (vidjeti dio 4.5).
English: Co-administration of REYATAZ and elbasvir/grazoprevir is contraindicated because of a significant increase in grazoprevir plasma concentrations and an associated potential increase in the risk of ALT elevations (see section 4.3).
Croatian: Istodobna primjena lijeka REYTAZ s elbasvirom/grazoprevirom je kontraindicirana zbog očekivanog povišenja koncentracije grazoprevira u plazmi te povezanim mogućim povećanjem rizika povišenja ALT-a (vidjeti dio 4.3).
English: Co-administration of REYATAZ with glecaprevir/pibrentasvir fixed dose combination is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecapreir and pibrentasvir plasma concentrations (see section 4.3).
Croatian: Istodobna primjena lijeka REYATAZ s lijekovima koje sadrže fiksnu kombinaciju glekaprevir/pibrentasvir, kontraindicirana je, jer postoji rizik povišenja vrijednosti ALT-a zbog značajnog povećanja koncentracije glekaprevira i pibrentasvira u plazmi (vidjeti dio 4.3).
English: REYATAZ 300 mg hard capsules atazanavir
Croatian: REYATAZ 300 mg tvrde kapsule atazanavir
English: Slovenská republika Bristol-Myers Squibb spol.
Croatian: Magyarország Bristol-Myers Squibb Kft.
English: REYATAZ 100 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Croatian: REYATAZ 100 mg tvrde kapsule isporučuju se i u blisterima u pakiranjima sa 60 kapsula.
English: NAME OF THE MEDICINAL PRODUCT REYATAZ 200 mg hard capsules atazanavir
Croatian: NAZIV LIJEKA REYATAZ 200 mg tvrde kapsule atazanavir
English: Co-administration of REYATAZ/ritonavir with other hormonal contraceptives or oral contraceptives containing progestogens other than norgestimate has not been studied, and therefore should be avoided (see section 4.5).
Croatian: Nije ispitana istovremena primjena lijeka REYATAZ/ritonavira i druge hormonske ili oralne kontracepcije koja sadrži progestagene, osim norgestimata, te se stoga mora izbjegavati (vidjeti dio
English: Therefore, REYATAZ with ritonavir is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Croatian: Stoga je REYATAZ s ritonavirom kontraindiciran s lijekovima koji su supstrati enzima CYP3A4 i imaju uzak terapijski raspon, kao što su: kvetiapin, lurasidon, alfuzozin, astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralno primijenjen midazolam i alkaloidi ergota, osobito ergotamin i dihidroergotamin (vidjeti dio 4.3).
English: REYATAZ 200 mg hard capsules atazanavir
Croatian: REYATAZ 200 mg tvrde kapsule atazanavir
English: Each capsule contains 150 mg of atazanavir (as sulphate).
Croatian: Jedna kapsula sadrži 150 mg atazanavira (u obliku atazanavirsulfata).
English: Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Croatian: Stoga je REYATAZ kontraindiciran s lijekovima koji su supstrati enzima CYP3A4 i imaju uzak terapijski raspon, kao što su: kvetiapin, lurasidon, alfuzozin, astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralno primijenjen midazolam i alkaloidi ergota, osobito ergotamin i dihidroergotamin (vidjeti dio 4.3).
English: a Mean baseline CD4 cell count was 214 cells/mm3 (range 2 to 810 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.94 log10 copies/ml (range 2.6 to 5.88 log10 copies/ml)
Croatian: a Prosječni broj CD4 stanica na početku iznosio je 214 stanica/mm3 (raspon od 2 do 810 stanica/mm3) i prosječna početna vrijednost HIV-1 RNK u plazmi bila je 4,94 log10 kopija/ml (raspon od 2,6 do 5,8 8 log10 kopija/ml)
English: NAME OF THE MEDICINAL PRODUCT REYATAZ 300 mg hard capsules atazanavir
Croatian: NAZIV LIJEKA REYATAZ 300 mg tvrde kapsule atazanavir
English: Capsule shells: gelatine, red iron oxide, black iron oxide, yellow iron oxide, indigocarmin (E132) and titanium dioxide (E171)
Croatian: Sadržaj kapsule: krospovidon, laktoza hidrat i magnezijev stearat Ovojnica kapsule: želatina, crveni željezov oksid, crni željezov oksid, žuti željezov oksid, indigokarmin (E132) i titanijev dioksid (E171)
English: Each capsule contains 200 mg of atazanavir (as sulphate).
Croatian: Jedna kapsula sadrži 200 mg atazanavira (u obliku atazanavirsulfata).
English: b ATV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Croatian: b ATV/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tabletama, jedanput na dan).
English: NAME OF THE MEDICINAL PRODUCT REYATAZ 100 mg hard capsules atazanavir
Croatian: NAZIV LIJEKA REYATAZ 100 mg tvrde kapsule atazanavir
English: Vascular disorders:
Croatian: EREKTILNA DISFUNKCIJA
English: 60 hard capsules: EU/1/03/267/005
Croatian: 60 tvrdih kapsula: EU/1/03/267/005
English: Each capsule contains 300 mg of atazanavir (as sulphate).
Croatian: Jedna kapsula sadrži 300 mg atazanavira (u obliku atazanavirsulfata).
English: Famotidine 40 mg twice daily Atazanavir AUC ↔2.3% (↓13%
Croatian: Atazanavir AUC ↔2.3% (↓13%
English: Each capsule contains 100 mg of atazanavir (as sulphate).
Croatian: Jedna kapsula sadrži 100 mg atazanavira (u obliku atazanavirsulfata).
English: SN:
Croatian: tkiva:
English: For treatment experienced paediatric patients, the mean baseline CD4 cell count was 522 cells/mm3 (range: 100 to 1157 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.09 log10 copies/ml (range: 3.28 to 5.00 log10 copies/ml).
Croatian: prosječni početni broj CD4 stanica iznosio je 522 stanica/mm3 (raspon: 100 do 1157 stanica/ mm3), a prosječna početna vrijednost HIV-1 RNK u plazmi iznosila je 4,09 log10 kopija/ml (raspon: 3,28 do 5,00 log10 kopija/ml).
English: Co-administration of salmeterol with REYATAZ is not recommended (see section 4.4).
Croatian: Ne preporučuje se istovremena primjena salmeterola i lijeka REYATAZ (vidjeti dio 4.4).
English: c Lopinavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Croatian: c Lopinavir/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tableti, jedanput na dan).
English: 60 hard capsules: EU/1/03/267/006
Croatian: 60 tvrdih kapsula: EU/1/03/267/006
English: NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET BRISTOL-MYERS
English: b REYATAZ/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Croatian: b REYATAZ/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tableti, jedanput na dan).
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: 6. POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: Co-administration of alfuzosin with REYATAZ is contraindicated (see section 4.3)
Croatian: Istovremena primjena alfuzosina i lijeka REYATAZ je kontraindicirana (vidjeti dio 4.3)
English: What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 200 mg contains 200 mg atazanavir.
Croatian: Jedna kapsula REYATAZ 200 mg sadrži 200 mg atazanavira.
English: What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 150 mg contains 150 mg atazanavir.
Croatian: Jedna kapsula REYATAZ 150 mg sadrži 150 mg atazanavira.
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Croatian: 2. NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: c LPV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Croatian: c LPV/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tabletama, jedanput na dan).
English: (range: 84 to 5703 cells/mm 3) and mean baseline plasma HIV-1 RNA was 4.67 log10 copies/ml (range: 2.0 to 5.9 log10 copies/ml).
Croatian: (raspon: 2 do 810 stanica /mm i srednja početna vrijednost HIV-1 RNK u plazmi bila je 4,94 log10 kopija/ml (raspon: 2,6 do
English: Co-administration of diltiazem and REYATAZ/ritonavir has not been studied.
Croatian: Istovremena primjena diltiazema i lijeka REYATAZ s ritonavirom nije ispitana.
English: Caution should be exercised when verapamil is coadministered with REYATAZ/ritonavir.
Croatian: Potreban je oprez kad se verapamil primjenjuje istovremeno s lijekom REYATAZ/ritonavir.
English: Co-administration of REYATAZ with voxilaprevir-containing regimens is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka REYATAZ s režimima koji uključuju voksilaprevir.
English: What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 100 mg contains 100 mg atazanavir.
Croatian: Jedna kapsula REYATAZ 100 mg sadrži 100 mg atazanavira.
English: Bristol-Myers Squibb Kft. Tel: + 371 67708347
Croatian: Bristol-Myers Squibb spol. s r.o. TEL: +385 1 2078 508
English: Week 96
Croatian: 6. DRUGO
English: Hepatobiliary disorders:
Croatian: Metabolizam:
English: ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily)
Croatian: Grazoprevir 200 mg jedanput na dan (atazanavir 300 mg / ritonavir 100 mg jedanput na dan)
English: Famotidine 20 mg twice daily Atazanavir AUC ↓18% (↓25% ↑1%) Atazanavir Cmax ↓20% (↓32% ↓7%)
Croatian: Atazanavir AUC ↓18% (↓25% ↑1%) Atazanavir Cmax ↓20% (↓32% ↓7%) Atazanavir Cmin ↔1% (↓16% ↑18%)
English: In HIV-infected patients with atazanavir/ritonavir at an increased dose of 400/100 mg once daily
Croatian: Primjena atazanavira/ritonavira u povišenoj dozi od 400/100 mg jedanput na dan u bolesnika zaraženih HIV-om Famotidin 20 mg dvaput na dan
English: Co-administration of efavirenz with REYATAZ/ritonavir is not recommended (see section 4.4)
Croatian: Ne preporučuje se istovremena primjena efavirenza i lijeka REYATAZ /ritonavira (vidjeti dio 4.4)
English: Bristol-Myers Squibb Kft. Tel: + 40 (0)21 272 16 00
Croatian: Česká republika Bristol-Myers Squibb spol. s r.o. Tel: +420 221 016 111
English: e)
Croatian: A.
English: No dosage adjustment is needed in patients with renal impairment.
Croatian: Nije potrebna prilagodba doze lijeka REYATAZ.
English: 80 mgc at least 15 to less than 35
Croatian: 80 mgc najmanje 20 do manje od 35 250 mg (5 vrećicab)
English: For treatmentexperienced paediatric patients, the mean baseline CD4 cell count was 522 cells/mm
Croatian: Srednja početna vrijednost broja CD4 stanica bila je 214 stanica/mm
English: uncommon: dyspnoea
Croatian: manje često: dispneja
English: Atazanavir
Croatian: Antineoplastici
English: the mean baseline CD4 cell count was 344 cells/mm3 (range: 2 to 800 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.67 log10 copies/ml (range: 3.70 to 5.00 log10 copies/ml).
Croatian: U pedijatrijskih bolesnika koji prethodno nisu bili liječeni, prosječni početni broj CD4 stanica bio je 344 stanice/mm3 (raspon: 2 do 800 stanica/ mm3), a prosječna početna vrijednost HIV-1 RNK u plazmi bila je 4,67 log10 kopija/ml (raspon: 3,70 do 5,00 log10 stanica/ml).
English: Oral use
Croatian: Djelotvornost
English: The mean baseline CD4 cell count was 214 cells/mm3 (range: 2 to 810 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.94 log10 copies/ml (range: 2.6 to 5.88 log10 copies/ml).
Croatian: a Prosječni broj CD4 stanica na početku iznosio je 214 stanica/mm3 (raspon od 2 do 810 stanica/mm3) i prosječna početna vrijednost HIV-1 RNK u plazmi bila je 4,94 log10 kopija/ml (raspon od 2,6 do 5,8 8 log10 kopija/ml) b REYATAZ/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tableti, jedanput na dan).
English: The frequency of this is unknown (see section 4.4).
Croatian: Učestalost osteonekroze nije poznata (vidjeti dio 4.4).
English: Co-administration of efavirenz and REYATAZ is not recommended (see section 4.4)
Croatian: Ne preporučuje se istovremena primjena efavirenza i lijeka REYATAZ (vidjeti dio 4.4)
English: REYATAZ is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition.
Croatian: Zbog inhibicije CYP3A4, očekuje se da će primjena lijeka REYATAZ povisiti razine lurasidona u plazmi.
English: Co-administration with glecaprevir/pibrentasvir fixed dose combination (see section 4.5)
Croatian: Istodobna primjena s lijekovima koji sadrže fiksnu kombinaciju glekaprevir/pibrentasvir (vidjeti dio
English: Your doctor will discuss this risk with you.
Croatian: Liječnik će s Vama raspraviti taj rizik.
English: Some cases had a fatal outcome.
Croatian: Neki su slučajevi imali smrtni ishod.
English: Unopened vial 18 months.
Croatian: Neotvorena bočica 18 mjeseci.
English: The duration of treatment can last up to 5 days.
Croatian: Liječenje može trajati i do 5 dana.
English: These effects were seen at doses lower than those used in humans.
Croatian: Ovi učinci su uočeni pri dozama nižim od onih koje se koriste kod ljudi.
English: The following information is intended for healthcare professionals only.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima.
English: You will receive your infusions every 12 or 24 hours.
Croatian: Infuzije ćete dobivati svakih 12 ili 24 sata.
English: The action of succinyl-choline can be prolonged by 5 to 15 minutes.
Croatian: Djelovanje sukcinil-kolina se može produžiti za 5-15 minuta.
English: 4.5 Interactions with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcija s drugim lijekovima i drugi oblici interakcija
English: The haematological recovery is in the expected time.
Croatian: Hematološki oporavak se odvija u predviđenim vremenima.
English: Your doctor will calculate the dose according to your body surface or weight and your disease.
Croatian: Liječnik će izračunati dozu, ovisno o Vašoj površini tijela ili težini i bolesti.
English: Each infusion will last 2-4 hours.
Croatian: Svaka infuzija traje 2-4 sata.
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 15 March 2015
Croatian: Datum posljednje obnove odobrenja: 15. ožujka 2015.
English: TEPADINA may cause another type of cancer in the future.
Croatian: TEPADINA može izazvati neku drugu vrstu raka u budućnosti.
English: - TEPADINA does not contain any other ingredients.
Croatian: - TEPADINA ne sadrži druge sastojke.
English: ADIENNE S.r.l.
Croatian: ADIENNE S.r.l. S.U.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika i normalno ne bi trebali biti duži od gore navedenih uvjeta, ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: TEPADINA can be used in adults and children and adolescents.
Croatian: TEPADINA se može koristiti u odraslih, djece i adolescenata.
English: However, in clinical studies, a proportion of patients over the age of 65 received the same cumulative dose as the other patients.
Croatian: Ipak, u kliničkim studijama, dio bolesnika preko 65 godina starosti je primio iste ukupne doze kao i ostali bolesnici.
English: Clinical safety and efficacy
Croatian: Klinička djelotvornost i sigurnost
English: Mental disorder due to a general medical condition
Croatian: Duševni poremećaji zbog općeg medicinskog stanja
English: Severe toxic skin reactions including cases of StevensJohnson syndrome and toxic epidermal necrolysis
Croatian: Teške toksične kožne reakcije uključujući slučajeve StevensJohnsonova sindroma i toksične epidermalne nekrolize
English: Pharmacotherapeutic group: Antineoplastic agents, Alkylating Agents, ATC code: L01AC01
Croatian: Farmakoterapijska skupina: Antineoplastici, alkilirajući pripravci, ATK oznaka: L01AC01
English: However, caution is recommended (see sections 4.4 and 5.2).
Croatian: U svakom slučaju, preporuča se oprez (vidjeti dio 4.4 i 5.2).
English: The safety of thiotepa has been examined through a review of adverse events reported in published data from clinical trials.
Croatian: Sigurnost tiotepe je ispitana analizirajući štetne događaje prikazane u objavljenim podacima kliničkih ispitivanja.
English: No conventional acute and repeat dose toxicity studies were performed.
Croatian: Nisu provedene konvencionalne studije o akutnoj toksičnosti i toksičnosti nakon ponovljenih doza.