natgillin/translations-raw huggingface dataset:
Very rare side effects (affects less than 1 user in 10,000) are: • Rash • Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset • Increased blood pressure • Decrease in the number of the platelets in the blood • Blood clot in an artery (for example stroke) • Headache including migraine • Mild breast symptoms such as pain, enlargement and tenderness
Zelo redki neželeni učinki (prizadanejo manj kot 1 uporabnika od 10. 000) so: • Izpuščaj • Gastrointestinalni simptomi kot so slabost, bruhanje, bolečina v trebuhu in razdražen želodec • Povišan krvni tlak • Zmanjšanje števila krvnih ploščic v krvi • Krvni strdek v arteriji (na primer kap) • Glavobol vključno z migreno • Blagi simptomi dojk kot so bolečina, povečanje in občutljivost
In rare cases, blood levels of liver enzymes may increase during treatment with EVISTA.
V redkih primerih se lahko med zdravljenjem z zdravilom EVISTA zvišajo koncentracije jetrnih encimov v krvi.
HOW TO STORE EVISTA
SHRANJEVANJE ZDRAVILA EVISTA
25 Keep out of the reach and sight of children.
Zdravilo shranjujte nedosegljivo otrokom!
What EVISTA contains
Kaj vsebuje zdravilo EVISTA
Each tablet contains 60 mg of raloxifene
Vsaka tableta vsebuje 60 mg raloksifenijevega
hydrochloride, which is equivalent to 56 mg raloxifene.
klorida, kar ustreza 56 mg raloksifena.
- The other ingredients of EVISTA tablets are:
- Pomožne snovi tablet EVISTA so:
Povidone, polysorbate 80, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate.
Jedro tablete: povidon, polisorbat 80, brezvodna laktoza, laktoza monohidrat, krospovidon, magnezijev stearat.
Titanium dioxide (E 171), polysorbate 80, hypromellose, macrogol 400, carnauba wax.
Obloga tablete: titanov dioksid (E171), polisorbat 80, hipromeloza, makrogol 400, karnauba vosek.
Shellac, propylene glycol, indigo carmine (E 132).
Črnilo: šelak, propilenglikol, indigotin (E132).
What EVISTA looks like and contents of the pack EVISTA are white, oval, film coated tablets which are marked with the number 4165.
Izgled zdravila EVISTA in vsebina pakiranja EVISTA so bele, ovalne, filmsko obložene tablete, ki so označene s številko 4165.
Not all pack sizes may be marketed.
V vseh državah na trgu ni vseh navedenih pakiranj.
Marketing Authorisation Holder Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, D-81379 Munich, Germany.
Imetnik dovoljenja za promet Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, D- 81379 Muenchen, Nemčija.
- Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spain.
Izdelovalec • Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas (Madrid), Španija.
26 For any information about this medicinal product, please contact the representative in your country:
26 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo v vaši državi:
Tel: +39-06 85 2551 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Latvija MediNet International Ltd.
Tel: +39- 06 85 2551 Κύπρος Phadisco Ltd
Tel: +421 2 4914 0172 Suomi/ Finland Meda Oy Puh. / Tel: +358 20 720 9550 Sverige Meda AB Tel: +46-(0) 8 630 19 00 United Kingdom Daiichi Sankyo UK Ltd Tel: +44-(0) 1753 893 600
Tel: +421 2 4914 0172 Suomi/ Finland Meda Oy Puh. / Tel: +358 20 720 9550 Sverige Meda AB
This leaflet was last approved in:
Tel: +371 67 805 140 Lietuva MediNet International Ltd.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu
Ref.
London, 24. april 2008 Sklic na dok.
It was to be used in patients who are not suitable for intensive chemotherapy, because they have certain genetic abnormalities in their myeloid cells, ‘ secondary’ AML (AML following a previous blood disorder) or another disease in addition to AML, or because they are 70 years of age or older.
Uporabljalo naj bi se pri bolnikih, pri katerih intenzivna kemoterapija ni primerna zaradi določenih genetskih nenormalnosti mieloidnih celic, „ drugotne “ AML (AML, ki sledi predhodni krvni motnji) ali druge bolezni, ki se pojavi hkrati z AML, oziroma ker so stari sedemdeset let ali več.
It belongs to the group of anti-cancer medicines called ‘ antimetabolites’.
Spada v skupino zdravil proti raku, ki jim pravimo „ antimetaboliti “.
The main measure of effectiveness was the number of patients who went into ‘ remission’ (clearance of leukaemia from the bone marrow and complete or partial recovery of blood cell counts to normal levels).
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila dosežena remisija (očistek levkemije iz kostnega mozga in popolno ali delno povečanje števila krvnih celic na normalne ravni).
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Evoltra could not have been approved for the treatment of the treatment of AML in elderly patients.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP v času umika vloge, je imel CHMP zadržke in bil začasnega mnenja, da zdravila Evoltra ni mogoče odobriti za zdravljenje AML pri starejših bolnikih.
The CHMP was concerned that the main study was not sufficient to establish the benefit of Evoltra in the treatment of AML in elderly patients who were unsuitable for intensive chemotherapy, and that the results of a study comparing Evoltra with standard treatment would be necessary to determine the medicine’ s effectiveness.
CHMP je imel zadržke, da glavna študija ni zadovoljivo dokazala koristnih učinkov zdravila Evoltra za zdravljenje AML pri starejših bolnikih, pri katerih izvajanje intenzivne kemoterapije ne bi bilo primerno, ter da bi bili za ugotovitev učinkovitosti zdravila potrebni rezultati študije, s katero bi primerjali učinke zdravila Evoltra z učinki pri standardnem zdravljenju.
There were also some concerns over the medicine’ s side effects affecting the kidneys.
Nekaj zadržkov je bilo tudi zaradi stranskih učinkov zdravila na ledvica.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of Evoltra had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Zato je CHMP v času umika menil, da koristi zdravila Evoltra niso bile zadostno dokazane in ne odtehtajo znanih tveganj.
Evoltra is used to treat children with acute lymphoblastic leukaemia (ALL), which is a cancer of the lymphocytes (a type of white blood cell).
Zdravilo Evoltra se uporablja za zdravljenje otrok z akutno limfoblastno levkemijo (ALL), rakom limfocitov (vrste belih krvnih celic).
Evoltra has been studied in patients less than 21 years old when they first became ill with ALL.
Zdravilo Evoltra so proučevali pri bolnikih, mlajših od 21 let, ki so prvič zboleli za ALL.
Because the number of patients with ALL is low, the disease is considered ‘ rare’, and Evoltra was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 5 February 2002.
Bolnikov z ALL je malo, bolezen je redka, zato je bilo zdravilo Evoltra dne 5. februarja 2002 določeno kot „ zdravilo sirota “ (zdravilo za redke bolezni).
Evoltra treatment should be started and supervised by a doctor who has experience in the management of patients with acute leukaemia.
Zdravljenje z zdravilom Evoltra lahko začne in vzdržuje le zdravnik, ki ima izkušnje z zdravljenjem bolnikov z akutno levkemijo.
The recommended dose is 52 mg per square metre body surface area (calculated using the child ’ s height and weight).
Priporočeni odmerek je 52 g na kvadratni meter telesne površine (izračunano glede na otrokovo višino in maso).
It is given by infusion lasting two hours every day for five days.
Daje se z infuzijo, ki traja dve uri vsak dan pet dni.
The treatment should be repeated every two to six weeks.
Zdravljenje je treba ponoviti vsaka dva do šest tednov.
It belongs to the group of anti-cancer medicines called ‘ antimetabolites’.
Spada v skupino zdravil proti raku, ki jim pravimo „ antimetaboliti ”.
Clofarabine is an ‘ analogue ’ of adenine, which is part of the fundamental genetic material of cells (DNA and RNA).
Klofarabin je analog adenina, ki je del osnovnega genetskega materiala celic (DNK in RNK).
This means that clofarabine takes the place of adenine in the body, and interferes with the enzymes involved in making genetic material, called ‘ DNA polymerase’ and ‘ RNA reductase’.
To pomeni, da klofarabin v telesu prevzame mesto adenina in ovira encime, ki sodelujejo pri izgradnji genetskega materiala, DNK polimerazo in RNK reduktazo.
The effects of Evoltra were first tested in experimental models before being studied in humans.
Učinki zdravila Evoltra so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Evoltra has been examined in one study of 61 patients below 21 years of age with ALL.
Zdravilo Evoltra je bilo proučevano v eni študiji na 61 bolnikih, mlajših od 21 let z ALL.
Reproduction is authorised provided the source is acknowledged. patients had previously received at least two other types of treatment but were not eligible for any other treatment.
Vsi bolniki so pred tem prejeli že vsaj dve drugi vrsti zdravljenja, vendar niso bili primerni za nobeno drugo zdravljenje.
The study did not compare Evoltra with any other treatments.
V študiji zdravila Evoltra niso primerjali s nobenimi drugimi zdravljenji.
In the main study, 20% of the patients went into remission (12 out of 61).
V glavni študiji je 20% bolnikov doseglo remisijo (12 od 61).
This is a complex procedure where the bone marrow of the patient, including the leukaemia cells, is destroyed and replaced by stem cells that ‘ recolonise’ the bone marrow.
To je zapleten postopek, pri katerem se kostni mozeg bolnika skupaj z levkemičnimi celicami uniči in nadomesti z zarodnimi celicami, ki „ rekolonizirajo “ kostni mozeg.
Stem cells are very young cells that are normally made in the bone marrow and can develop into all of the different types of blood cell.
Zarodne celice so zelo mlade celice, ki nastajajo v kostnem mozgu, in se lahko razvijejo v različne vrste krvnih celic.
In studies, the most common side effects with Evoltra (seen in more than 1 patient in 10) were febrile neutropenia (low white blood cell counts with fever), anxiety, headache, flushing (reddening of the face), vomiting, diarrhoea, nausea (feeling sick), dermatitis (inflammation of the skin), pruritus (itching), pyrexia (fever), mucosal inflammation (inflammation of the moist body surfaces, such as the lining of the mouth) and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Evoltra v študijah (opaženi pri več kot 1 bolniku od 10) so bili febrilna nevtropenija (nizko število belih krvničk s spremljajočo povišano telesno temperaturo), tesnoba, glavobol, vročinski oblivi (pordelost obraza), bruhanje, driska, slabost, dermatitis (vnetje kože), pruritus (srbenje), pireksija (povišana telesna temperatura), mukozno vnetje (vnetje sluznice, kot je ustna sluznica) in utrujenost.
For the full list of all side effects reported with Evoltra, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Evoltra, glejte navodilo za uporabo.
Evoltra should not be used in people who may be hypersensitive (allergic) to clofarabine or any of the other ingredients.
Zdravila Evoltra ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) klofarabin ali katero koli drugo sestavino zdravila.
Evoltra must not be given to patients with severe kidney or liver disease.
Zdravilo Evoltra se ne sme uporabljati pri bolnikih s hudimi boleznimi ledvic ali jeter.
Because Evoltra is a cytotoxic medicine, it should not be used during pregnancy unless absolutely necessary and breast-feeding should be stopped before, during and after treatment.
Evoltra je citotoksično zdravilo, zato se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno, z dojenjem pa je treba prenehati pred zdravljenjem, med njim in po njem.
Patients with ALL who have not responded to or who have relapsed after receiving at least two treatments have a very poor chance of survival.
Bolniki z ALL, ki se niso odzvali na zdravljenje ali pri katerih bolezen se je ponovila po vsaj dveh zdravljenjih, imajo zelo malo možnosti za preživetje.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Evoltra treatment may provide a way of obtaining remission, and of facilitating a stem cell transplant.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je z zdravilom Evoltra možno doseči remisijo in olajšati presaditev zarodnih celic.
The Committee decided that Evoltra’ s benefits are greater than its risks for the treatment of ALL in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.
Odbor je sklenil, da so koristi zdravila Evoltra večje od z njim povezanih tveganj pri zdravljenju ALL pri pediatričnih bolnikih, pri katerih se je bolezen po vsaj dveh režimih zdravljenja ponovila ali je refraktarna in kadar pri nobeni drugi obliki zdravljenja ne pričakujemo trajnega odziva.
The Committee recommended that Evoltra be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Evoltra odobri dovoljenje za promet.
Evoltra has been authorised under ‘ Exceptional Circumstances’.
Zdravilo Evoltra je bilo odobreno „ v izjemnih okoliščinah “.
The company that makes Evoltra will carry out a study to look at the use of Evoltra in patients with kidney disease, and set up a registry to monitor the medicine ’ s side effects.
Družba, ki izdeluje zdravilo Evoltra, bo izvedla študijo o uporabi zdravila Evoltra pri bolnikih z boleznijo ledvic ter vzpostavila register za spremljanje neželenih učinkov tega zdravila.
Which measures are being taken to ensure the safe use of Evoltra?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Evoltra?
The company that makes Evoltra will make sure that doctors know about the best way to use Evoltra, and encourage them to use the registry for monitoring side effects.
Družba, ki izdeluje zdravilo Evoltra, bo zagotovila, da bodo zdravniki seznanjeni z najboljšim načinom uporabe zdravila Evoltra, in jih spodbujala, da uporabljajo register za spremljanje neželenih učinkov zdravila.
Other information about Evoltra:
Druge informacije o zdravilu Evoltra:
The European Commission granted a marketing authorisation valid throughout the European Union for Evoltra on 29 May 2006.
Evropska komisija je dovoljenje za promet z zdravilom Evoltra, veljavno po vsej Evropski uniji, odobrila dne 29. maja 2006.
The marketing authorisation holder is Genzyme Europe B. V.
Imetnik dovoljenja za promet je družba Genzyme Europe B. V
The summary of opinion of the Committee for Orphan Medicinal Products for Evoltra is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Evoltra je na voljo tukaj.
The full EPAR for Evoltra is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Evoltra je na voljo tukaj.
Evoltra 1 mg/ ml concentrate for solution for infusion
Evoltra 1 mg/ ml koncentrat za pripravo raztopine za infundiranje
Each 20 ml vial contains 20 mg of clofarabine.
Ena 20- mililitrska viala vsebuje 20 mg klofarabina.
Each 20 ml vial contains 180 mg of sodium chloride.
Vsaka 20- mililitrska viala vsebuje 180 mg natrijevega klorida.
Concentrate for solution for infusion (sterile concentrate).
Koncentrat za pripravo raztopine za infundiranje (sterilni koncentrat).
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.
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.
Zdravljenje akutne limfoblastne levkemije (ALL) pri pediatričnih bolnikih, pri katerih se bolezen po vsaj dveh režimih zdravljenja ponovi ali je refraktarna, kadar pri nobeni drugi obliki zdravljenja ne pričakujemo trajnega odziva.
Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis (see section 5.1).
Varnost in učinkovitost so ocenili v študijah na bolnikih, starih ≤ 21 let pri prvi diagnozi (glejte poglavje 5. 1).
Therapy must be initiated and supervised by a physician experienced in the management of patients with acute leukaemias.
Zdravljenje lahko začne in vzdržuje le zdravnik, ki ima izkušnje z zdravljenjem bolnikov z akutnimi levkemijami.
Adults (including the elderly):
Odrasli (vključno s starejšimi bolniki):
There are currently insufficient data to establish the safety and efficacy of clofarabine in adult patients (see section 5.2).
Na voljo ni dovolj podatkov, da bi ocenili varnost in učinkovitost klofarabina pri odraslih bolnikih (glejte poglavje 5. 2).
The recommended dose is 52 mg/ m2 of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days.
Priporočeni odmerek je 52 mg/ m2 telesne površine, v obliki intravenske infuzije; infundiranje traja 2 uri dnevno, 5 dni zaporedoma.
Body surface area must be calculated using the actual height and weight of the patient before the start of each cycle.
Telesno površino je treba izračunati na podlagi dejanske višine in teže bolnika pred začetkom vsakega cikla.
Treatment cycles should be repeated every 2 to 6 weeks (from the starting day of the previous cycle) following recovery of normal haematopoiesis (i. e.
Cikle zdravljenja je treba ponoviti vsakih 2 do 6 tednov (od začetka prejšnjega cikla) po vzpostavitvi normalne hematopoeze (tj.
ANC ≥ 0.75 × 109/ l) and return to baseline organ function.
ANC (absolutno število nevtrofilcev) ≥ 0, 75 × 109/ l) in izhodiščnega delovanja organov.
A 25% dose reduction may be warranted in patients experiencing significant toxicities (see below).
Pri bolnikih z izrazitimi toksični učinki lahko uporabite 25% manjši odmerek (glejte spodaj).
There is currently limited experience of patients receiving more than 3 treatment cycles (see section 4.4).
Izkušnje z bolniki, ki prejemajo več kot 3 cikle zdravljenja, so trenutno omejene (glejte poglavje 4. 4).
The majority of patients who respond to clofarabine achieve a response after 1 or 2 treatment cycles (see section 5.1).
Pri večini bolnikov, ki se odzovejo na zdravljenje s klofarabinom, do odziva pride po 1 ali 2 ciklih zdravljenja (glejte poglavje 5. 1).
Therefore, the potential benefit and risks associated with continued therapy in patients who do not show haematological and/ or clinical improvement after 2 treatment cycles should be assessed by the treating physician (see section 4.4).
Zato mora lečeči zdravnik pri bolnikih, ki po 2 ciklih zdravljenja ne kažejo hematološkega in/ ali kliničnega izboljšanja, oceniti morebitne koristi in tveganje, povezane z neprekinjenim zdravljenjem (glejte poglavje 4. 4).
Children (weighing < 20 kg):
Otroci (ki tehtajo < 20 kg):
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).
Morda bo potreben čas infundiranja > 2 uri, da bi zmanjšali simptome tesnobe in razdražljivosti ter preprečili pretirane maksimalne koncentracije klofarabina (glejte poglavje 5. 2).
2 Children (< 1 year old):
Otroci (stari < 1 leto):
There are no data on the pharmacokinetics, safety or efficacy of clofarabine in infants.
Podatkov o farmakokinetiki, varnosti in učinkovitosti klofarabina pri novorojencih ni.
Therefore, a safe and effective dosage recommendation for patients (< 1 year old) has yet to be established.
Varna in učinkovita priporočila za odmerjanje pri bolnikih (starih < 1 let) je treba šele ugotoviti.
Patients with renal insufficiency:
Bolniki z oslabljenim delovanjem ledvic:
There is no experience in patients with renal insufficiency (serum creatinine ≥ 2 x ULN for age) and clofarabine is predominately excreted via the kidneys.
Z uporabo pri bolnikih z oslabljenim delovanjem ledvic (serumski kreatinin ≥ 2 x ULN (Upper Limits of Normal – zgornja normalna meja) za starost bolnika) ni izkušenj, klofarabin pa se večinoma izloča skozi ledvice.
Therefore, clofarabine is contraindicated in patients with severe renal insufficiency (see section 4.3) and should be used with caution in patients with mild to moderate renal insufficiency (see section 4.4).
Zato je uporaba klofarabina pri bolnikih s hudo oslabljenim delovanjem ledvic kontraindicirana (glejte poglavje 4. 3), pri bolnikih z blago do zmerno okvarjenimi ledvicami pa ga je treba uporabljati previdno (glejte poglavje 4. 4).
To date, there are insufficient data on the pharmacokinetics of clofarabine in patients with decreased creatinine clearance to advise a dose reduction in such patients.
Do sedaj še ni dovolj podatkov o farmakokinetiki klofarabina pri bolnikih z zmanjšanim kreatininskim očistkom, zaradi katerih bi pri teh bolnikih svetovali zmanjšanje odmerka.
However, these limited data indicate that clofarabine may accumulate in patients with decreased creatinine clearance (see sections 4.4 and 5.2).
Vendar ti omejeni podatki kažejo, da se lahko klofarabin pri bolnikih z zmanjšanim kreatininskim očistkom kopiči (glejte poglavji 4. 4 in 5. 2).
There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity.
Izkušenj z uporabo pri bolnikih z okvarjenim delovanjem jeter (serumski bilirubin > 1, 5 x ULN, AST in ALT > 5 x ULN) ni, poleg tega so jetra lahko tarča za toksične učinke.
Therefore, clofarabine is contraindicated in patients with severe hepatic impairment (see section 4.3) and should be used with caution in patients with mild to moderate hepatic impairment (see section 4.4).
Zato je uporaba klofarabina pri bolnikih s hudo okvarjenim delovanjem jeter kontraindicirana (glejte poglavje 4. 3), pri bolnikih z blago do zmerno okvarjenim delovanjem jeter pa ga je treba uporabljati previdno (glejte poglavje 4. 4).
Dose reduction for patients experiencing haematological toxicities:
Zmanjšanje odmerka pri bolnikih, pri katerih se pojavijo hematološki toksični učinki:
If the ANC does not recover by 6 weeks from the start of a treatment cycle, a bone marrow aspirate / biopsy should be performed to determine possible refractory disease.
Če se absolutno število nevtrofilcev ne popravi v 6 tednih od začetka zdravljenja, je treba opraviti aspiracijo/ biopsijo kostnega mozga in oceniti možnost refraktarne bolezni.
If persistent leukaemia is not evident, it is recommended that the dose for the next cycle be reduced by 25% of the previous dose following recovery of ANC to ≥ 0.75 × 109/ l.
Če ni znakov perzistentne levkemije, se po izboljšanju vrednosti ANC (Absolute Neutrophile Count – absolutno število nevtrofilcev) na ≥ 0, 75 × 109/ l priporoča zmanjšanje odmerka naslednjega cikla za 25% prejšnjega odmerka.
Should patients experience an ANC < 0.5 × 109/ l for more than 4 weeks from the start of the last cycle, it is recommended that the dose for the next cycle be reduced by 25%.
Če je vrednost ANC pri bolnikih več kot 4 tedne od začetka zadnjega cikla < 0, 5 × 109/ l, se priporoča zmanjšanje odmerka v naslednjem ciklu za 25%.
Dose reduction for patients experiencing non-haematological toxicities:
Zmanjšanje odmerka pri bolnikih, pri katerih se pojavijo nehematološki toksični učinki:
Infectious events:
Okužbe:
In the event of a second clinically significant infection, clofarabine treatment should be withheld until the infection is clinically controlled and may be reinitiated at a 25% dose reduction.
Če znova pride do klinično pomembne okužbe, je treba zdravljenje s klofarabinom prekiniti, dokler okužba ni klinično nadzorovana, nato pa se zdravljenje lahko nadaljuje z odmerkom, zmanjšanim za 25%.
Non-infectious events:
Dogodki, ki niso povezani z okužbami: