natgillin/translations-raw huggingface dataset:
The CHMP noted that the SCOUT data clearly demonstrates that patients with obesity and known CV disease taking sibutramine are exposed to an increased risk for CV events compared with placebo.
CHMP je opazil, da podatki iz študije SCOUT jasno kažejo, da so bili bolniki z debelostjo in znano kardiovaskularno boleznijo, ki so prejemali sibutramin, izpostavljeni večjemu tveganju kardiovaskularnih dogodkov kot bolniki, ki so prejemali placebo.
The CHMP considered that an increased CV risk may also apply to patients for whom sibutramine can be prescribed since overweight or obese patients are likely to be at risk for cardiovascular disease.
CHMP je menil, da so povečanemu tveganju kardiovaskularne bolezni lahko izpostavljeni tudi bolniki, katerim je mogoče predpisati sibutramin, saj so bolniki s prekomerno telesno maso ali debelostjo pogosto izpostavljeni tveganju kardiovaskularne bolezni.
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C. F. Tietgens Boulevard 40 DK-5220 Odense SØ Danska
Although patients on sibutramine as well as patients on placebo experienced decreased CV event rates when losing weight compared to those who did not, CV events were increased with the use of sibutramine compared to placebo suggesting that the weight loss achieved with sibutramine was not sufficient to counter-balance its adverse CV effects.
Čeprav je bilo tako pri bolnikih, zdravljenih s sibutraminom, kot tudi pri bolnikih, ki so prejemali placebo, opaziti zmanjšanje pogostosti kardiovaskularnih dogodkov ob izgubi telesne mase v primerjavi z bolniki, pri katerih se telesna masa ni zmanjševala, se je pri uporabi sibutramina pogostost kardiovaskularnih dogodkov bolj povečala kot pri uporabi placeba, kar kaže, da izguba telesne mase po zaslugi sibutramina ni bila dovolj velika, da bi odtehtala njegove neželene kardiovaskularne učinke.
This was acknowledged, however the CHMP considered that the data shows that the risk of CV events for patients continued on sibutramine was higher than if continued on placebo.
CHMP je to upošteval, vendar je menil, da je iz podatkov razvidno, da je bilo tveganje kardiovaskularnih dogodkov pri bolnikih, ki so nadaljevali zdravljenje s sibutraminom, večje kot pri bolnikih, ki so nadaljevali s placebom.
Sibutramine treatment resulted in a higher incidence of POEs (specifically non-fatal myocardial infarction and stroke were the drivers) compared with placebo in patients with a history of a cardiovascular disease (these patients were acknowledged as Summary of Product Characteristics (SPC) non-conformers).
Pri zdravljenju s sibutraminom so opazili večjo pogostost dogodkov primarnega izida (zlasti miokardnega infarkta in srčne kapi brez smrtnega izida) kot pri placebu pri bolnikih z anamnezo kardiovaskularne bolezni (ti bolniki so veljali za nekonformne glede na povzetek glavnih značilnosti zdravila).
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10 mg Film-coated tablet oral use
10 mg filmsko obložena tableta
15 mg Film-coated tablet oral use
15 mg filmsko obložena tableta
Sibutramine should be used in conjunction with a reduced calorie diet and increased physical activity in - Patients with nutritional obesity and a body mass index (BMI) of 30 kg/m2 or higher.
Sibutramin je namenjen uporabi skupaj z nizkokalorično dieto in povečano fizično aktivnostjo pri - bolnikih s prehransko pogojeno debelostjo in indeksom telesne mase (ITM) 30 kg/m2 ali več, - bolnikih s prehransko pogojeno prekomerno telesno maso in ITM 27 kg/m2 ali več, če so prisotni drugi dejavniki tveganja, povezani z debelostjo, kot je sladkorna bolezen tipa 2 ali dislipidemija.
U kabelovny 130, 102 37 Prague 10
U kabelovny 130, 102 37 Praga 10
By the end of the Randomization Phase, patients on sibutramine achieved a further mean reduction in weight of 0.91 kg while the placebo group experienced a mean increase of 1.02 kg compared with baseline Randomization Phase measurements.
V fazi uvajanja (v kateri so vse osebe zdravili s sibutraminom) je v populaciji z namenom zdravljenja (ITT) začetna povprečna izguba telesne mase pri zdravljenju s sibutraminom znašala 2,6 kg. Do konca faze randomizacije so pri bolnikih, ki so prejemali sibutramin, opazili nadaljnje povprečno zmanjšanje telesne mase za 0,91 kg, medtem ko se je telesna masa v skupini s placebom v povprečju povečala za 1,02 kg v primerjavi z meritvami na začetku faze randomizacije.
SIBUTRAL 10 mg, gélule 10 mg capsule oral use
SIBUTRAL 10 mg, gélule 10 mg kapsula
Similarly, the proposed yearly PSUR reporting cycle was considered unlikely to promote SPC compliance regarding prescription.
Poleg tega je menil, da predlagano letno poročanje z rednimi posodobljenimi poročili o varnosti zdravila ni ustrezno za zagotovitev skladnosti povzetka glavnih značilnosti zdravila z vidika predpisovanja.
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U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Czech Republic
U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Češka
SIBUTRAL 15 mg, gélule 15 mg capsule oral use
SIBUTRAL 15 mg, gélule 15 mg kapsula
SE-169 29, Solna Sweden
SE-169 29, Solna Švedska
Sibutril 15 mg capsules, hard 15 mg Capsule, hard oral
Sibutril 15 mg capsules, hard 15 mg kapsula, trda peroralna
Sibutril 10 mg capsules, hard 10 mg Capsule, hard oral
Sibutril 10 mg capsules, hard 10 mg kapsula, trda peroralna
Zelium 10 mg Hartkapseln 10 mg Capsule, hard oral use
Zelium 10 mg Hartkapseln 10 mg kapsula, trda
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16929 Solna Sweden
16929 Solna Švedska
SE-169 29 Solna Sweden
SE-169 29 Solna Švedska
Zelium 15 mg Hartkapseln 15 mg Capsule, hard oral use
Zelium 15 mg Hartkapseln 15 mg kapsula, trda
LINDAXA 15 mg, capsule 15 mg Capsule, hard oral use
LINDAXA 15 mg, capsule 15 mg kapsula, trda
Sibutramin Sandoz 10 mg 10 mg Capsule, hard oral use
Sibutramin Sandoz 10 mg 10 mg kapsula, trda
15 mg capsule oral use
15 mg kapsula
LINDAXA 10 mg, capsule 10 mg Capsule, hard oral use
LINDAXA 10 mg, capsule 10 mg kapsula, trda
Sibutramin Sandoz 15 mg 15 mg Capsule, hard oral use
Sibutramin Sandoz 15 mg 15 mg kapsula, trda
10 mg capsule oral use
10 mg kapsula
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169 29 Solna Švedska
Sibutramina Argam 10 mg Capsule, hard oral use
Sibutramina Argam 10 mg kapsula, trda
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Sibutramina West Pharma 15 mg Capsule, hard oral use
Sibutramina West Pharma 15 mg kapsula, trda
Sibutramina West Pharma 10 mg Capsule, hard oral use
Sibutramina West Pharma 10 mg kapsula, trda
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Reductil 15 mg - Hartkapseln 15 mg Capsule, hard oral use
Reductil 15 mg - Hartkapseln 15 mg kapsula, trda peoralna uporaba
Reductil 10 mg - Hartkapseln 10 mg Capsule, hard oral use
Reductil 10 mg - Hartkapseln 10 mg kapsula, trda peoralna uporaba
Sibutramina Argam 15 mg Capsule, hard oral use
Sibutramina Argam 15 mg kapsula, trda
SILUTON 15 mg, capsule 15 mg Capsule, hard oral use
SILUTON 15 mg, capsule 15 mg kapsula, trda
SILUTON 10 mg, capsule 10 mg Capsule, hard oral use
SILUTON 10 mg, capsule 10 mg kapsula, trda
Sitrane 10 mg hard capsules 10 mg Capsule, hard oral use
Sitrane 10 mg hard capsules 10 mg kapsula, trda
MINIMACIN 10 mg, capsule 10 mg Capsule, hard oral use
MINIMACIN 10 mg, capsule 10 mg kapsula, trda
MINIMACIN 15 mg, capsule 15 mg Capsule, hard oral use
MINIMACIN 15 mg, capsule 15 mg kapsula, trda
Sitrane 15 mg hard capsules 15 mg Capsule, hard oral use
Sitrane 15 mg hard capsules 15 mg kapsula, trda
SIBUTRAMIN SANDOZ 10 mg Capsule, hard oral use
SIBUTRAMIN SANDOZ 10 mg kapsula, trda
Reductil 10 mg trde kapsule 10 mg Capsule, hard oral use
Reductil 10 mg trde kapsule 10 mg kapsula, trda
SIBUTRAMIN SANDOZ 15 mg Capsule, hard oral use
SIBUTRAMIN SANDOZ 15 mg kapsula, trda
Reductil 15 mg trde kapsule 15 mg Capsule, hard oral use
Reductil 15 mg trde kapsule 15 mg kapsula, trda
Reductil 10 mg hard capsules 10 mg Capsule, hard oral use
Reductil 10 mg hard capsules 10 mg kapsula, trda
Reductil 15 mg hard capsules 15 mg Capsule, hard oral use
Reductil 15 mg hard capsules 15 mg kapsula, trda
Sibutramin Teva 15 mg Kapseln
Sibutramin Teva 15 mg Kapseln peoralna uporaba
REDUCTIL 10 mg, capsule 10 mg Capsule, hard oral use
REDUCTIL 10 mg, capsule 10 mg kapsula, trda
REDUCTIL 15 mg, capsule 15 mg Capsule, hard oral use
REDUCTIL 15 mg, capsule 15 mg kapsula, trda
Reduxade 10 mg Hartkapseln 10 mg Capsule, hard oral use
Reduxade 10 mg Hartkapseln 10 mg kapsula, trda
SIBUTRAMINA TEVA 15 mg Capsule, hard oral use
SIBUTRAMINA TEVA 15 mg kapsula, trda
Sibutramin Teva 10 mg Kapseln
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Reduxade 15 mg Hartkapseln 15 mg Capsule, hard oral use
Reduxade 15 mg Hartkapseln 15 mg kapsula, trda
Reductil 10 mg Hartkapseln 10 mg Capsule, hard oral use
Reductil 10 mg Hartkapseln 10 mg Kapsula, trda
Reductil 15 mg Hartkapseln 15 mg Capsule, hard oral use
Reductil 15 mg Hartkapseln 15 mg Kapsula, trda
EU/1/06/334/001 3 vials EU/1/06/334/002 4 vials EU/1/06/334/003 10 vials EU/1/06/334/004 20 vials EU/1/06/334/005 1 vial
EU/1/06/334/001 3 viale EU/1/06/334/002 4 viale EU/1/06/334/003 10 vial EU/1/06/334/004 20 vial EU/1/06/334/005 1 viala
From a microbiological point of view, it should be used immediately.
Z mikrobiološkega stališča je treba zdravilo porabiti takoj.
Your doctor will give you Evoltra once every day for 5 days.
Zdravnik vam bo dajal zdravilo Evoltra enkrat na dan 5 dni zaporedoma.
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okvirju izvesti naslednje ukrepe:
Estimates based on non-compartmental analysis (n = 14 / n = 14)
Ocena, ki temelji na nekompartmentalni analizi (n = 14/n = 14)
Adults (> 21 and < 65 years old)
Odrasli (stari > 21 in < 65 let)
The median age of treated patients (37 males, 24 females) was 12 years old.
Mediana starosti sodelujočih bolnikov (37 moških, 24 ženskih) je bila 12 let.
It is a clear, almost colourless solution that is prepared and diluted before it is used.
Je bistra, skoraj brezbarvna raztopina, ki jo je treba pred uporabo pripraviti in razredčiti.
1 vial 3 vials 4 vials 10 vials 20 vials
1 viala 3 viale 4 viale 10 vial 20 vial
Your doctor will tell you when you need to be given this medicine.
Zdravnik vam bo povedal, kdaj vam bodo dali zdravilo.
Each box contains 1, 3, 4, 10 or 20 vials.
Vsaka škatla vsebuje 1, 3, 4, 10 ali 20 vial.
Your doctor will carry out regular blood tests to check whether your body is working properly; - liver damage (liver failure).
Zdravnik bo opravljal redne krvne preiskave, da bo preveril, ali telo deluje normalno; okvara jeter (odpoved jeter).
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Genzyme Ltd 37 Hollands Road Haverhill Suffolk
Therefore, Evoltra should not be used during pregnancy, especially not during the first trimester, unless clearly necessary (i.e. only if the potential benefit to the mother outweighs the risk to the foetus).
Zato se zdravilo Evoltra ne sme uporabljati med nosečnostjo, zlasti ne v prvem trimesečju, razen če je nujno potrebno (tj. samo, če koristi zdravljenja matere odtehtajo tveganje za plod).
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred uporabo natančno preberite navodilo, ker vsebuje za vas pomembne podatke
During treatment with Evoltra, your doctor will carry out regular blood tests and other tests to monitor your health.
Med zdravljenjem z zdravilom Evoltra bo zdravnik opravljal redne krvne in druge preiskave, s katerimi bo spremljal vaše zdravstveno stanje.
Most of the cardiac adverse events were reported in the first 2 cycles.
Večino neželenih dogodkov, povezanih s srčnimi boleznimi, so poročali med prvima 2 cikloma.
• DNA polymerase  inhibition resulting in termination of DNA chain elongation and/or DNA synthesis / repair.
• Inhibicija DNA polimeraze , zaradi katere pride do terminacije elongacije verige DNA in/ali sinteze/popravljanja DNA.
(If the use of a 0.2 micrometre syringe filter is not feasible, the concentrate should be pre-filtered with a 5 micrometre filter, diluted and then administered through a 0.22 micrometre in-line filter.)
(Če 0,2-mikrometrskega filtra v brizgi ni mogoče uporabiti, je treba koncentrat predhodno filtrirati s 5-mikrometrskim filtrom, ga razredčiti in nato dajati skozi 0,22-mikrometrski linijski filter.)
• An M2 bone marrow ( 5% and ≤ 25% blasts) and appearance of normal progenitor cells
• kostni mozeg M2 ( 5% in ≤ 25% blastov) in pojav normalnih progenitornih celic
Each box contains 1, 3, 4, 10 or 20 vials, but not all pack sizes may be marketed.
Vsaka škatla vsebuje 1, 3, 4, 10 ali 20 vial, vendar na trgu mogoče ni vseh navedenih pakiranj.
• The use of prophylactic steroids (e.g., 100 mg/m hydrocortisone on Days 1 through 3) may be of benefit in preventing signs or symptoms of SIRS or capillary leak.
• Uporaba profilaktičnih steroidov (npr. 100 mg/m2 hidrokortizona od 1. do 3. dne) lahko koristi pri preprečevanju znakov ali simptomov SIRS ali kapilarne krvavitve.
No studies on the effects of clofarabine on the ability to drive and use machines have been performed.
Študij o vplivu klofarabina na sposobnost vožnje in upravljanja s stroji niso izvedli.
If you forget to use Evoltra
Če ste pozabili uporabiti zdravilo Evoltra
The 12 patients who achieved an overall remission (CR + CRp) had a median survival time of 66.6 weeks as of the data collection cut-off date.
Pri 12 bolnikih, pri katerih je prišlo do skupne remisije (PR + PRt), je bila mediana časa preživetja 66,6 tednov od datuma zbiranja podatkov.
Toxicology studies of clofarabine in mice, rats and dogs showed that rapidly proliferating tissues were the primary target organs of toxicity.
Toksikološke študije klofarabina na miših, podganah in psih so pokazale, da so bila hitro proliferajoča tkiva primarni ciljni organi za toksične učinke.
* = see below **All adverse reactions occurring at least twice (i.e., 2 or more reactions (1.7%)) are included in this table
* = glejte spodaj ** V tabeli zgoraj so vključeni vsi neželeni učinki, ki so se pojavili najmanj dvakrat (tj., 2 ali več neželenih učinkov (1,7 %))
What Evoltra is and what it is used for
Kaj je zdravilo Evoltra in za kaj ga uporabljamo
As a result, it is not expected to affect the metabolism of active substances which are known substrates for these enzymes.
Zato ni pričakovati, da bi vplival na presnovo zdravilnih učinkovin, za katere je znano, da so substrati teh encimov.
Evoltra must not be mixed with or concomitantly administered using the same intravenous line as other medicinal products (see section 6.2).
Zdravila Evoltra ne smete mešati ali ga istočasno dajati po isti intravenski liniji z drugimi zdravili (glejte poglavje 6.2).
Adverse reactions are listed by system organ class and frequency (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) and very rare (< 1/10,000)) in the table below.
V spodnji tabeli so neželeni učinki navedeni po organskih sistemih in pogostnosti (zelo pogosti (1/10), pogosti (1/100 do <1/10), občasni (1/1.000 do <1/100), redki (1/10.000 do <1/1.000) in zelo redki (<1/10.000).
This is equivalent to 3.08 mmol (or 70.77 mg) of sodium.
To ustreza 3,08 mmol (ali 70,77 mg) natrija.
Adsorption and distribution
Absorbcija in porazdelitev
If you use more Evoltra than you should If you think you may have been given too much medicine, tell your doctor straight away.
Če ste uporabili večji odmerek zdravila Evoltra, kot bi smeli Če menite, da so vam dali preveč zdravila, takoj povejte zdravniku.
Date of first authorisation: 29 May 2006.
Datum pridobitve dovoljenja za promet: 29. maj 2006 Datum zadnjega podaljšanja dovoljenja za promet: 14. januar 2016
Evoltra contains salt
Zdravilo Evoltra vsebuje sol
Before Evoltra is given to you, it will be diluted in a sodium chloride solution (salt and water).
Preden vam bodo dali zdravilo Evoltra, ga bodo razredčili v raztopini natrijevega klorida (sol in voda).
Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l.
Prozorna, skoraj brezbarvna raztopina s pH 4,5 do 7,5 in osmolarnostjo 270 do 310 mOsm/l.
• Respiratory status, blood pressure, fluid balance and weight throughout and immediately after the 5 day clofarabine administration period.
• Respiratorni status, krvni tlak, ravnotežje tekočin in telesno maso ves čas 5-dnevnega obdobja dajanja klofarabina in takoj po njem.
• Renal and hepatic function prior to, during active treatment and following therapy.
• Delovanje ledvic in jeter pred zdravljenjem, med aktivnim zdravljenjem in po njem.
Evoltra may harm both male and female reproductive organs.
Zdravilo Evoltra lahko škodljivo vpliva na moške in ženske spolne organe.
No interaction studies have been performed.
Študij interakcij do sedaj še niso opravili.
CR * Duration of remission censored at the time of transplant ** Patient received a transplant following alternate therapy *** Patient received a transplant following relapse
PR * Trajanje remisije preverjeno ob času presaditve ** Pri bolniku je bila izvedena presaditev po alternativnem zdravljenju *** Pri bolniku je bila izvedena presaditev po relapsu
This is usually reversible and appears to be dosedependent.
Ta je navadno reverzibilna in kaže, da je odvisna od odmerka.
• Patients who met all of the criteria for a CR except for recovery of platelet counts to > 100 x 10
• Bolniki, ki izpolnjujejo vsa merila za PR, razen obnovitve števila trombocitov na > 100 x 109/l
What you need to know before you use Evoltra
Kaj morate vedeti, preden boste uporabili zdravilo Evoltra
An infusion time of > 2 hours should be considered to help reduce symptoms of anxiety and irritability, and to avoid unduly high maximum concentrations of clofarabine (see section 5.2).
Potrebno je razmisliti o času infundiranja > 2 uri, da bi zmanjšali simptome tesnobe in razdražljivosti ter preprečili pretirano visoke maksimalne koncentracije klofarabina (glejte poglavje 5.2).
Therefore, it is unlikely to interact with active substances which inhibit or induce cytochrome P450 enzymes.
Zato ni verjetno, da bi medsebojno deloval z zdravilnimi učinkovinami, ki zavirajo ali sprožajo delovanje encimov citokroma P450.
PR = Partial Remission
DR = Delna remisija
It was observed that the frequency and severity of adverse reactions, in particular infection, myelosuppression (neutropenia) and hepatotoxicity, are increased when clofarabine is used in combination.
Ugotovljeno je bilo, da se pogostnost in resnost neželenih učinkov, zlasti okužbe, mielosupresija (nevtropenija) in hepatotoksičnost, poveča, če se klofarabin uporablja v kombinaciji.
Uncommon side effects (may affect up to 1 in 100 people): - inflammation of the liver (hepatitis).
Občasni neželeni učinki (pojavijo se lahko prinajveč 1 od 100 oseb): - vnetje jeter (hepatitis).
Tell your doctor if you are on a controlled sodium diet as it could affect how you will be given your medicine.
Povejte zdravniku, če imate dieto za nadzor natrija, ker to lahko vpliva na način dajanja zdravila.
These infections may lead to septic shock, respiratory failure, renal failure, and/or multiorgan failure.
Te okužbe lahko povzročijo septični šok, odpoved dihal, odpoved ledvic in/ali odpoved več organov.
Once prepared and diluted, Evoltra should be used straight away or within 24 hours if stored in a refrigerator (at 2
Ko je zdravilo Evoltra pripravljeno in razredčeno, ga je treba porabiti takoj ali v 24 urah, če je shranjeno v hladilniku (pri 2°C do 8°C).
Therapy must be initiated and supervised by a physician experienced in the management of patients with acute leukaemias.
Zdravljenje mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z akutnimi levkemijami.
However, Cmax is inversely proportional to patient weight and, therefore, small children may have a higher Cmax at the end of infusion than a typical 40 kg child given the same dose of clofarabine per m2.
Vendar je vrednost Cmax obratno sorazmerna s telesno maso bolnika, zato je pri majhnih otrocih vrednost Cmax na koncu infundiranja lahko večja kot pri tipičnem 40 kg otroku, ki prejme enak odmerek klofarabina na m2.
Clinical efficacy: To enable systematic evaluation of the responses seen in patients, an unblinded Independent Response Review Panel (IRRP) determined the following response rates based on definitions produced by the Children's Oncology Group:
Klinična učinkovitost: Da bi omogočili sistematično oceno odzivov pri bolnikih, so v neodvisni panelni raziskavi odzivov (Independent Response Review Panel - IRRP) določili naslednje stopnje odziva, glede na opredelitve Skupine za otroško onkologijo (Children's Oncology Group): PR = Popolna remisija
It works best against cells which are multiplying quickly - such as cancer cells.
Najučinkovitejše je proti celicam, ki se hitro delijo, kot so rakaste celice.
In addition, clofarabine treatment should be discontinued if the patient develops hypotension for any reason during the 5 days of administration.
Poleg tega je treba zdravljenje s klofarabinom prekiniti, če se pri bolniku med 5-dnevnim odmerjanjem razvije hipotenzija zaradi kateregakoli vzroka.
Do not use Evoltra: - if you are allergic to clofarabine or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding (please read the section “Pregnancy and breast-feeding” below); - if you have severe kidney or liver problems.
Ne uporabljajte zdravila Evoltra: - če ste alergični na klofarabin ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če dojite (prosimo, preberite poglavje Nosečnost in dojenje spodaj); - če imate hude težave z ledvicami ali jetri.
• Disruption of mitochondrial membrane integrity with the release of cytochrome C and other proapoptotic factors leading to programmed cell death even in non-dividing lymphocytes.
• Motnje integritete mitohondrijske membrane s sproščanjem citokroma C in drugih proapoptotičnih faktorjev, kar povzroči programirano celično smrt, tudi pri limfocitih, ki se ne delijo.
If you are breast-feeding, you must stop breast-feeding before starting the treatment, and must not breast-feed during your treatment and within 3 months after completion of your treatment.
Če dojite, morate z dojenjem prekiniti pred začetkom zdravljenja in ne smete dojiti niti med zdravljenjem in3 mesece po končanem zdravljenju.
Ask your pharmacist how to throw away medicines you no longer use.
O načinu odstanjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
In addition, clofarabine is unlikely to inhibit any of the major 5 human CYP isoforms (1A2, 2C9, 2C19, 2D6 and 3A4) or to induce 2 of these isoforms (1A2 and 3A4) at the plasma concentrations achieved following intravenous infusion of 52 mg/m2/day.
Poleg tega ni verjetno, da bi klofarabin zaviral katerokoli od 5 glavnih izoform CYP pri človeku (1A2, 2C9, 2C19, 2D6 in 3A4) ali da bi sprožil delovanje 2 od teh izoform (1A2 in 3A4) pri doseženih koncentracijah v plazmi po intravenski infuziji 52 mg/m2/dan.
Evoltra is for single use only.
Zdravilo Evoltra je samo za enkratno uporabo.
Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, ATC code: L01BB06.
Farmakoterapevtska skupina: Pripravki za zdravljenje novotvorb, zaviralci celične presnove (antimetaboliti), oznaka ATC: L01BB06.
• Ribonucleotide reductase inhibition with reduction of cellular deoxynucleotide triphosphate (dNTP) pools.
• Inhibicija ribonukleotid reduktaze z zmanjšanjem zalog celičnih deoksinukleotid trifosfatov