natgillin/translations-raw huggingface dataset:
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.
Neprozirna plava i bijela kapsula s otisnutim "BMS 100 mg" na jednoj polovici i "3623" na drugoj polovici plavom i bijelom tintom.
The co-administration of REYATAZ/ritonavir with stavudine is not expected to significantly alter the exposure of stavudine.
Ne očekuje se da će istovremena primjena stavudina i lijeka REYATAZ/ritonavira značajno promijeniti izloženost stavudinu.
Serum concentrations of verapamil may be increased by REYATAZ due to CYP3A4 inhibition.
REYATAZ može povisiti koncentracije verapamila u serumu zbog inhibicije enzima CYP3A4.
REYATAZ 100 mg hard capsules atazanavir
REYATAZ 100 mg tvrde kapsule atazanavir
REYATAZ with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.4 and 5.2).
Ne preporučuje se primjenjivati REYATAZ s ritonavirom u bolesnika na hemodijalizi (vidjeti dijelove 4.4 i 5.2).
REYATAZ 100 mg hard capsules are supplied in bottles of 60 capsules.
REYATAZ 100 mg tvrde kapsule isporučuju se u bocama sa 60 kapsula.
Kidney stones have been reported in patients taking REYATAZ.
U bolesnika koji uzimaju REYATAZ zabilježeni su bubrežni kamenci.
If you get any side effects talk to your doctor, or pharmacist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
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).
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).
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).
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).
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).
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).
REYATAZ 300 mg hard capsules atazanavir
REYATAZ 300 mg tvrde kapsule atazanavir
Slovenská republika Bristol-Myers Squibb spol.
Magyarország Bristol-Myers Squibb Kft.
REYATAZ 100 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
REYATAZ 100 mg tvrde kapsule isporučuju se i u blisterima u pakiranjima sa 60 kapsula.
NAME OF THE MEDICINAL PRODUCT REYATAZ 200 mg hard capsules atazanavir
NAZIV LIJEKA REYATAZ 200 mg tvrde kapsule atazanavir
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).
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
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).
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).
REYATAZ 200 mg hard capsules atazanavir
REYATAZ 200 mg tvrde kapsule atazanavir
Each capsule contains 150 mg of atazanavir (as sulphate).
Jedna kapsula sadrži 150 mg atazanavira (u obliku atazanavirsulfata).
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).
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).
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)
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)
NAME OF THE MEDICINAL PRODUCT REYATAZ 300 mg hard capsules atazanavir
NAZIV LIJEKA REYATAZ 300 mg tvrde kapsule atazanavir
Capsule shells: gelatine, red iron oxide, black iron oxide, yellow iron oxide, indigocarmin (E132) and titanium dioxide (E171)
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)
Each capsule contains 200 mg of atazanavir (as sulphate).
Jedna kapsula sadrži 200 mg atazanavira (u obliku atazanavirsulfata).
b ATV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
b ATV/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tabletama, jedanput na dan).
NAME OF THE MEDICINAL PRODUCT REYATAZ 100 mg hard capsules atazanavir
NAZIV LIJEKA REYATAZ 100 mg tvrde kapsule atazanavir
Vascular disorders:
EREKTILNA DISFUNKCIJA
60 hard capsules: EU/1/03/267/005
60 tvrdih kapsula: EU/1/03/267/005
Each capsule contains 300 mg of atazanavir (as sulphate).
Jedna kapsula sadrži 300 mg atazanavira (u obliku atazanavirsulfata).
Famotidine 40 mg twice daily Atazanavir AUC ↔2.3% (↓13%
Atazanavir AUC ↔2.3% (↓13%
Each capsule contains 100 mg of atazanavir (as sulphate).
Jedna kapsula sadrži 100 mg atazanavira (u obliku atazanavirsulfata).
SN:
tkiva:
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).
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).
Co-administration of salmeterol with REYATAZ is not recommended (see section 4.4).
Ne preporučuje se istovremena primjena salmeterola i lijeka REYATAZ (vidjeti dio 4.4).
c Lopinavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
c Lopinavir/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tableti, jedanput na dan).
60 hard capsules: EU/1/03/267/006
60 tvrdih kapsula: EU/1/03/267/006
NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET BRISTOL-MYERS
b REYATAZ/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
b REYATAZ/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tableti, jedanput na dan).
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.
6. POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
Co-administration of alfuzosin with REYATAZ is contraindicated (see section 4.3)
Istovremena primjena alfuzosina i lijeka REYATAZ je kontraindicirana (vidjeti dio 4.3)
What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 200 mg contains 200 mg atazanavir.
Jedna kapsula REYATAZ 200 mg sadrži 200 mg atazanavira.
What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 150 mg contains 150 mg atazanavir.
Jedna kapsula REYATAZ 150 mg sadrži 150 mg atazanavira.
METHOD OF ADMINISTRATION Read the package leaflet before use.
2. NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
c LPV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
c LPV/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tabletama, jedanput na dan).
(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).
(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
Co-administration of diltiazem and REYATAZ/ritonavir has not been studied.
Istovremena primjena diltiazema i lijeka REYATAZ s ritonavirom nije ispitana.
Caution should be exercised when verapamil is coadministered with REYATAZ/ritonavir.
Potreban je oprez kad se verapamil primjenjuje istovremeno s lijekom REYATAZ/ritonavir.
Co-administration of REYATAZ with voxilaprevir-containing regimens is not recommended.
Ne preporučuje se istodobna primjena lijeka REYATAZ s režimima koji uključuju voksilaprevir.
What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 100 mg contains 100 mg atazanavir.
Jedna kapsula REYATAZ 100 mg sadrži 100 mg atazanavira.
Bristol-Myers Squibb Kft. Tel: + 371 67708347
Bristol-Myers Squibb spol. s r.o. TEL: +385 1 2078 508
Week 96
6. DRUGO
Hepatobiliary disorders:
Metabolizam:
ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily)
Grazoprevir 200 mg jedanput na dan (atazanavir 300 mg / ritonavir 100 mg jedanput na dan)
Famotidine 20 mg twice daily Atazanavir AUC ↓18% (↓25% ↑1%) Atazanavir Cmax ↓20% (↓32% ↓7%)
Atazanavir AUC ↓18% (↓25% ↑1%) Atazanavir Cmax ↓20% (↓32% ↓7%) Atazanavir Cmin ↔1% (↓16% ↑18%)
In HIV-infected patients with atazanavir/ritonavir at an increased dose of 400/100 mg once daily
Primjena atazanavira/ritonavira u povišenoj dozi od 400/100 mg jedanput na dan u bolesnika zaraženih HIV-om Famotidin 20 mg dvaput na dan
Co-administration of efavirenz with REYATAZ/ritonavir is not recommended (see section 4.4)
Ne preporučuje se istovremena primjena efavirenza i lijeka REYATAZ /ritonavira (vidjeti dio 4.4)
Bristol-Myers Squibb Kft. Tel: + 40 (0)21 272 16 00
Česká republika Bristol-Myers Squibb spol. s r.o. Tel: +420 221 016 111
e)
A.
No dosage adjustment is needed in patients with renal impairment.
Nije potrebna prilagodba doze lijeka REYATAZ.
80 mgc at least 15 to less than 35
80 mgc najmanje 20 do manje od 35 250 mg (5 vrećicab)
For treatmentexperienced paediatric patients, the mean baseline CD4 cell count was 522 cells/mm
Srednja početna vrijednost broja CD4 stanica bila je 214 stanica/mm
uncommon: dyspnoea
manje često: dispneja
Atazanavir
Antineoplastici
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).
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).
Oral use
Djelotvornost
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).
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).
The frequency of this is unknown (see section 4.4).
Učestalost osteonekroze nije poznata (vidjeti dio 4.4).
Co-administration of efavirenz and REYATAZ is not recommended (see section 4.4)
Ne preporučuje se istovremena primjena efavirenza i lijeka REYATAZ (vidjeti dio 4.4)
REYATAZ is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition.
Zbog inhibicije CYP3A4, očekuje se da će primjena lijeka REYATAZ povisiti razine lurasidona u plazmi.
Co-administration with glecaprevir/pibrentasvir fixed dose combination (see section 4.5)
Istodobna primjena s lijekovima koji sadrže fiksnu kombinaciju glekaprevir/pibrentasvir (vidjeti dio
Your doctor will discuss this risk with you.
Liječnik će s Vama raspraviti taj rizik.
Some cases had a fatal outcome.
Neki su slučajevi imali smrtni ishod.
Unopened vial 18 months.
Neotvorena bočica 18 mjeseci.
The duration of treatment can last up to 5 days.
Liječenje može trajati i do 5 dana.
These effects were seen at doses lower than those used in humans.
Ovi učinci su uočeni pri dozama nižim od onih koje se koriste kod ljudi.
The following information is intended for healthcare professionals only.
Sljedeće informacije namijenjene su samo zdravstvenim radnicima.
You will receive your infusions every 12 or 24 hours.
Infuzije ćete dobivati svakih 12 ili 24 sata.
The action of succinyl-choline can be prolonged by 5 to 15 minutes.
Djelovanje sukcinil-kolina se može produžiti za 5-15 minuta.
4.5 Interactions with other medicinal products and other forms of interaction
4.5 Interakcija s drugim lijekovima i drugi oblici interakcija
The haematological recovery is in the expected time.
Hematološki oporavak se odvija u predviđenim vremenima.
Your doctor will calculate the dose according to your body surface or weight and your disease.
Liječnik će izračunati dozu, ovisno o Vašoj površini tijela ili težini i bolesti.
Each infusion will last 2-4 hours.
Svaka infuzija traje 2-4 sata.
Date of first authorisation: 15 March 2010 Date of latest renewal: 15 March 2015
Datum posljednje obnove odobrenja: 15. ožujka 2015.
TEPADINA may cause another type of cancer in the future.
TEPADINA može izazvati neku drugu vrstu raka u budućnosti.
- TEPADINA does not contain any other ingredients.
- TEPADINA ne sadrži druge sastojke.
ADIENNE S.r.l.
ADIENNE S.r.l. S.U.
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.
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.
TEPADINA can be used in adults and children and adolescents.
TEPADINA se može koristiti u odraslih, djece i adolescenata.
However, in clinical studies, a proportion of patients over the age of 65 received the same cumulative dose as the other patients.
Ipak, u kliničkim studijama, dio bolesnika preko 65 godina starosti je primio iste ukupne doze kao i ostali bolesnici.
Clinical safety and efficacy
Klinička djelotvornost i sigurnost
Mental disorder due to a general medical condition
Duševni poremećaji zbog općeg medicinskog stanja
Severe toxic skin reactions including cases of StevensJohnson syndrome and toxic epidermal necrolysis
Teške toksične kožne reakcije uključujući slučajeve StevensJohnsonova sindroma i toksične epidermalne nekrolize
Pharmacotherapeutic group: Antineoplastic agents, Alkylating Agents, ATC code: L01AC01
Farmakoterapijska skupina: Antineoplastici, alkilirajući pripravci, ATK oznaka: L01AC01
However, caution is recommended (see sections 4.4 and 5.2).
U svakom slučaju, preporuča se oprez (vidjeti dio 4.4 i 5.2).
The safety of thiotepa has been examined through a review of adverse events reported in published data from clinical trials.
Sigurnost tiotepe je ispitana analizirajući štetne događaje prikazane u objavljenim podacima kliničkih ispitivanja.
No conventional acute and repeat dose toxicity studies were performed.
Nisu provedene konvencionalne studije o akutnoj toksičnosti i toksičnosti nakon ponovljenih doza.
Reconstituted solutions may occasionally show opalescence; such solutions can still be administered.
Rekonstituirane otopine ponekad mogu opalescirati; takve otopine se mogu primjenjivati.
Previous brain irradiation or craniospinal irradiation may contribute to severe toxic reactions (e.g. encephalopathy).
Prethodno zračenje mozga ili kraniospinalno zračenje mogu doprinjeti teškim toksičnim reakcijama (npr. encefalopatija).
The total excreted amount of thiotepa and its identified metabolites accounts for 54-100% of the total alkylating activity, indicating the presence of other alkylating metabolites.
Ukupna količina izlučene tiotepe i njenih identificiranih metabolita predstavlja 54-100% od ukupne alkilirajuće aktivnosti, što upućuje na prisustvo drugih alkilirajućih metabolita.
What TEPADINA is and what it is used for
Što je TEPADINA i za što se koristi
In these studies, a total of 6,588 adult patients and 902 paediatric patients received thiotepa for conditioning treatment prior to haematopoietic progenitor cell transplantation.
U ovim ispitivanjima je ukupno 6588 odraslih bolesnika i 902 pedijatrijska bolesnika primalo tiotepu kao pripremnu terapiju prije transplantacije hematopoetskih matičnih stanica.
Thiotepa is a highly lipophilic compound.
Tiotepa je vrlo lipofilan spoj.
Alkylating chemotherapeutic agents, including thiotepa, inhibit plasma pseudocholinesterase by 35% to 70%.
Alkilirajući kemoterapeutici, uključujući tiotepu, inhibiraju plazmatsku pseudokolinesterazu za 35% do 70%.
Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Liječnik će redovito nadgledati broj krvnih stanica kao i enzime jetre kako bi otkrio i kontrolirao takve događaje.
Specific interactions with thiotepa
Specifične interakcije s tiotepom
You should tell your doctor if you have: - liver or kidney problems, - heart or lung problems, - seizures/fits (epilepsy) or have had them in the past (if treated with phenytoin or fosphenytoin).
Obavijestite liječnika ako imate: - probleme s jetrom ili bubrezima, - probleme sa srcem ili plućima, - napadaje (epilepsiju), ili ako ste ih imali u prošlosti (ako se liječite s fenitoinom ili fosfofenitoinom).
Dose modification is not recommended for transient alterations of hepatic parameters (see section 4.4).
Ne preporučuje se promjena doziranja u slučaju prolaznih promjena jetrenih parametara (vidjeti dio 4.4).
Toxic shock syndrome
Toksični šok sindrom
20867 Caponago (MB) Italy
20867 Caponago (MB) Italija
Filtering does not alter solution potency.
Filtriranje ne mijenja djelotvornost otopine.
The pharmacokinetics of high dose thiotepa in children between 2 and 12 years of age do not appear to vary from those reported in children receiving 75 mg/m2 or adults receiving similar doses.
Farmakokinetika visokih doza tiotepe u djece u dobi između 2 i 12 godina se ne razlikuje od one koja je prijavljena u djece koja su primala 75 mg/m ili u odraslih kojima se daju slične doze.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
Engraftment: Engraftment has been achieved (92%-100%) in all reported conditioning treatments and it was considered to occur at the expected time.
Prihvat transplantata: Ostvaren je prihvat (92% -100%) u svim pripremnim liječenjima i smatra se da je do toga došlo u očekivano vrijeme.
There is no known antidote for thiotepa.
Nema poznatog antidota za tiotepu.
Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Treba razmotriti profilaktičku ili empirijsku uporabu antiinfektivnih lijekova (bakterijskih, gljivičnih, virusnih) za prevenciju i liječenje infekcija za vrijeme trajanja neutropenije.
An inactivated virus vaccine should be used instead, whenever possible (poliomyelitis).
Alternativno, koristite inaktivirano cjepivo gdje je to moguće (poliomijelitis).
The fraction unbound to proteins in plasma is 70-90%; insignificant binding of thiotepa to gamma globulin and minimal albumin binding (10-30%) has been reported.
Dio koji nije vezan na proteine plazme iznosi 70-90%; utvrđeno je neznatno povezivanje tiotepe s gama globulinima i minimalno povezivanje s albuminima (10-30%).
Further dilution in the infusion bag
Daljnje razrjeđenje u infuzijskoj vrećici
Respiratory arrest
Respiratorni arest
Mental status changes
Promjene mentalnog stanja
Each carton contains 1 vial.
Svaka kutija sadrži 1 bočicu.
Urinary excretion of thiotepa and TEPA is nearly complete after 6 and 8 hours respectively.
Mokraćno izlučivanje tiotepe i TEPA je gotovo potpuno nakon 6 odnosno 8 sati.
White crystalline powder.
Bijeli kristalinični prašak.
GvHD (graft versus host disease): all conditioning treatments evaluated assured a low incidence of acute GvHD grade III-IV (from 4% to 24%).
Bolest transplantata protiv domaćina (GvHD): sva procijenjena pripremna liječenja su osigurala nisku incidenciju akutnog GvHD, razreda III-IV (od 4% do 24%).
These metabolites are not found in urine, and, if formed, are probably excreted in bile or as intermediate metabolites rapidly converted into thiotepa-mercapturate.
Ove metabolite se ne može naći u mokraći, a ako se formiraju, vjerojatno se izlučuju u žuči ili se kao intermedijarni metaboliti brzo pretvaraju u tiotepu merkapturat.
Gastrointestinal ulcer
Gastrointestinalni ulkus
Therefore, thiotepa is contraindicated during pregnancy.
Dakle, primjena tiotepe je kontraindicirana u trudnoći.
Frequency of administration and duration of treatment depend on your disease.
Učestalost davanja lijeka i trajanje liječenja ovise o bolesti.
Women of childbearing potential have to use effective contraception during treatment and a pregnancy test should be performed before treatment is started.
Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja; potrebno je prije početka liječenja napraviti test za trudnoću.
Live attenuated vaccines (except yellow fever): risk of systemic, possibly fatal disease.
Živa atenuirana cjepiva (osim cjepiva protiv žute groznice): rizik od sistemske bolesti, potencijalno fatalno.
It is not known whether this medicinal product is excreted in breast milk.
Nije poznato izlučuje li se ovaj lijek u majčinom mlijeku.