natgillin/translations-raw huggingface dataset:
The infusion rate can continue to be increased according to standard procedures, to physician discretion and to patient tolerance (not to exceed doubling the rate every 30 minutes).
Hitrost infundiranja je mogoče še naprej povečevati v skladu s standardnimi postopki, zdravnikovo presojo in bolnikovim prenašanjem (hitrosti se ne sme podvojevati prej kot na vsakih 30 minut).
Do not use the Arzerra concentrate if there is discolouration.
Če je koncentrat zdravila Arzerra obarvan, ga ne uporabite.
Ofatumumab may cause foetal B-cell depletion based on findings from animal studies and on its mechanism of action (see section 5.1).
Po podatkih iz študij na živalih in na osnovi mehanizma delovanja ofatumumaba lahko to zdravilo povzroči znižanje števila celic B pri plodu (glejte poglavje 5.1).
If a diagnosis of PML is suspected Arzerra should be discontinued and referral to a neurologist should be considered.
V primeru suma na PML je treba zdravljenje z zdravilom Arzerra prekiniti; v poštev pride napotitev bolnika k nevrologu.
Median creatinine clearance (CrCl), assessed with the use of the Cockroft-Gault formula, was 70 ml/min and 48% of patients had a CrCl of <70 ml/min.
Mediani očistek kreatinina (CrCl), ocenjen po Cockroft-Gaultovi formuli, je bil 70 ml/min in 48 % bolnikov je imelo očistek kreatinina < 70 ml/min.V študijo so bili vključeni bolniki s stanjem zmogljivosti od 0 do 2 po ECOG (Eastern Cooperative Oncology Group) in 91 % bolnikov je imelo stanje zmogljivosti 0 ali 1 po ECOG.
2) How to dilute the solution for infusion
2) Redčenje raztopine za infundiranje
One ml of concentrate contains 20 mg of ofatumumab.
En ml koncentrata vsebuje 20 mg ofatumumaba.
• blue discolouration of the lips and extremities (possible symptoms of hypoxia)
• pomodrelost ustnic in okončin (možni znaki slabe oskrbe s kiskom).
4.8 Undesirable effects
Zelo pogosti neželeni učinki
• throat pain or irritation
• bolečine ali draženje v žrelu,
You should be tested for hepatitis B (a liver disease) before starting Arzerra treatment.
Pred začetkom zdravljenja z zdravilom Arzerra morate opraviti testiranje za hepatitis B (bolezen jeter).
PFS based on local (investigator) assessment was consistent with the primary endpoint and resulted in a ~11-month improvement in median PFS (OFA+FC 27.2 months versus 16.8 months for FC; HR=0.66 (95% CI: 0.51, 0.85, p=0.0009).
Lokalno ocenjeno preživetje brez napredovanja bolezni po oceni raziskovalca se je ujemalo s primarnim opazovanim dogodkom in je pokazalo podaljšanje mediane preživetja brez napredovanja bolezni za približno 11 mesecev (27,2 meseca v skupini OFA+FC v primerjavi s 16,8 meseca v skupini FC; razmerje ogroženosti 0,66 (95% IZ: 0,51, 0,85, p = 0,0009).
Each vial contains 100 mg ofatumumab in 5 ml.
Vsaka viala vsebuje 100 mg ofatumumaba v 5 ml.
Study OMB110911 (randomised, open-label, parallel-arm, multicentre) evaluated the efficacy of Arzerra in combination with chlorambucil compared with chlorambucil alone in 447 patients with previously untreated CLL considered inappropriate for fludarabine-based treatment (e.g. due to advanced age or presence of co-morbidities), with active disease and indicated for treatment.
Primerjala je učinkovitost zdravila Arzerra v kombinaciji s klorambucilom z učinkovitostjo samega klorambucila pri 447 bolnikih s predhodno nezdravljeno KLL, ki niso bili primerni za zdravljenje na podlagi fludarabina (npr. zaradi visoke starosti ali komorbidnih stanj) ter so imeli aktivno bolezen in indikacijo za zdravljenje.
• Withdraw 5 ml of ofatumumab from each of the three 100 mg vials and inject into the 1000 ml bag;
• Potegnite 5 ml ofatumumaba iz vsake od treh vial s 100 mg in ga injicirajte v 1.000-ml vrečko.
Risk factors for TLS include a high tumour burden, high concentrations of circulating cells (≥25,000/mm hypovolaemia, renal insufficiency, elevated pre-treatment uric acid levels and elevated lactate dehydrogenase levels.
Med dejavniki tveganja za sindrom lize tumorja so veliko tumorsko breme, velika koncentracija celic v obtoku (≥25.000/mm
Musculoskeletal and connective tissue disorders General disorders and administration site conditions syndrome*, chills (including rigors)*, hyperhidrosis*
sindrom sproščanja citokinov*, mrzlica (vključno z drgetanjem)*, hiperhidroza*
For patients who show evidence of prior (HBsAg negative, anti-HBc positive) hepatitis B infection, physicians with expertise in managing hepatitis B should be consulted regarding monitoring and initiation of HBV antiviral therapy.
Če ima bolnik izvid, ki dokazuje predhodno okužbo s hepatitisom B (HBsAg-negativen, anti-HBc-pozitiven), se je treba glede nadziranja in glede uvedbe protivirusnega zdravljenja proti HBV posvetovati z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B. Zdravljenja z zdravilom Arzerra se ne sme začeti pri bolnikih z izvidom, ki dokazuje trenutno okužbo s hepatitisom B (HBsAg-pozitiven), dokler okužba ni ustrezno zdravljena.
Each vial contains 1000 mg ofatumumab in 50 ml.
Vsaka viala vsebuje 1.000 mg ofatumumaba v 50 ml.
Hypersensitivity to ofatumumab or to any of the excipients listed in section 6.1.
Preobčutljivost za ofatumumab ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
There was a rapid and sustained depletion of CD20
+, s čimer se je zmanjšalo število celic CD20
Arzerra 100 mg concentrate for solution for infusion 300 mg dose: Use 3 vials (15 ml total, 5 ml per vial) - Withdraw and discard 15 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; - Withdraw 5 ml of ofatumumab from each of 3 vials and inject into the 1000 ml bag; - Do not shake; mix diluted solution by gentle inversion.
Arzerra 100 mg koncentrat za raztopino za infundiranje Odmerek 300 mg: Uporabite 3 viale (skupaj 15 ml, 5 ml na vialo) - Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 15 ml
Uncommon symptoms of an infusion-related reaction (may affect up to 1 in 100 people):
Občasni simptomi z infundiranjem povezanih reakcij (pojavijo se lahko pri največ 1 od 100 oseb):
The primary endpoint of progression-free survival (PFS), as assessed by a blinded independent review committee (IRC) using the updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008), was prolonged in the ofatumumab plus fludarabine-cyclophosphamide (OFA+FC) arm compared to the fludarabine-cyclophosphamide (FC) arm (28.9 months versus 18.8 months; HR: 0.67; 95% CI: 0.51-0.88, p=0.0032) resulting in a 10-month improvement in median PFS (see Figure 2).
V skupini z ofatumumabom skupaj s fludarabinom in ciklofosfamidom (OFA+FC) je bilo preživetje brez napredovanja bolezni daljše kot v skupini s fludarabinom in ciklofosfamidom (FC) (28,9 meseca v primerjavi z 18,8 meseca; razmerje ogroženosti: 0,67; 95% IZ: 0,51-0,88, p = 0,0032), kar pomeni podaljšanje medianega preživetja brez napredovanja bolezni za 10 mesecev (glejte sliko 2).
Common symptoms of an infusion-related reaction (may affect up to 1 in 10 people):
Pogosti simptomi z infundiranjem povezane reakcije (pojavijo se lahko pri največ 1 od 10 oseb):
Age was not found to be a significant factor for ofatumumab pharmacokinetics in a cross-study population pharmacokinetic analysis of patients ranging in age from 21 to 87 years of age.
Farmakokinetična analiza populacije več študij (bolniki v starosti od 21 do 87 let) je pokazala, da starost ni pomemben dejavnik farmakokinetike ofatumumaba.
Nervous system disorders Metabolism and nutrition disorders
Bolezni živčevja Presnovne in prehranske motnje sindrom lize tumorja
• diarrhoea
• zardevanje
If you get any side effects, talk to your doctor or nurse.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance >30 ml/min).
Bolnikom z blago do zmerno okvaro ledvic (očistek kreatinina > 30 ml/min) odmerka ni treba prilagoditi.
Hepatitis B virus (HBV) infection and reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has occurred in patients treated with medicinal products classified as CD20directed cytolytic antibodies, including Arzerra.
Pri bolnikih, zdravljenih z zdravili, ki se uvrščajo med citolitična protitelesa, usmerjena proti CD20 (vključno z zdravilom Arzerra), se je pojavila okužba z virusom hepatitisa B (HBV) ali njena reaktivacija, v nekaterih primerih s posledičnim fulminantnim hepatitisom, odpovedjo jeter in smrtjo.
Arzerra 1000 mg concentrate for solution for infusion 1000 mg dose: Use 1 vial (50 ml total, 50 ml per vial) - Withdraw and discard 50 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; - Withdraw 50 ml of ofatumumab from the vial and inject into the 1000 ml bag; - Do not shake; mix diluted solution by gentle inversion.
Arzerra 1000 mg koncentrat za raztopino za infundiranje Odmerek 1.000 mg: Uporabite 1 vialo (skupaj 50 ml, 50 ml na vialo) - Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 50 ml
• Withdraw 50 ml of ofatumumab from the 1000 mg vial and inject into the 1000 ml bag
• Potegnite 50 ml ofatumumaba iz viale s 1.000 mg in ga injicirajte v 1.000-ml vrečko.
The overall response rate (ORR) including complete response (CR) was also assessed by an IRC using the 2008 IWCLL guidelines.
IRC je po smernicah IWCLL 2008 ocenil tudi celokupni delež odziva (ORR - overall response rate), vključno s popolnim odzivom (CRcomplete response).
Diluted infusion solution
Razredčena raztopina za infundiranje
Infusion schedule
Razpored infuzij
Bradycardia*
Srčne bolezni bradikardija*
2000 mg dose: Use 2 vials (100 ml total, 50 ml per vial) - Withdraw and discard 100 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; - Withdraw 50 ml of ofatumumab from each of 2 vials and inject into the 1000 ml bag; - Do not shake; mix diluted solution by gentle inversion.
Odmerek 2.000 mg: Uporabite 2 viali (skupaj 100 ml, 50 ml na vialo) - Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 100 ml
Arzerra 100 mg concentrate for solution for infusion Arzerra 1000 mg concentrate for solution for infusion
Arzerra 100 mg koncentrat za raztopino za infundiranje Arzerra 1000 mg koncentrat za raztopino za infundiranje
Cardiovascular
Srčno-žilni
• shaking or shivering
• tresenje ali drgetanje,
Respiratory, thoracic and mediastinal disorders oropharyngeal pain*, nasal congestion*
Bolezni dihal, prsnega koša in mediastinalnega prostora nelagodje v prsih*,
For the first infusion, administer over 4.5 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below:
Prvo infuzijo je treba dati v 4,5 ure (glejte poglavje 4.2) po periferni liniji ali stalnem katetru in po naslednjem časovnem razporedu:
• allergic reactions, sometimes severe where symptoms include raised and itchy rash (hives),
• alergijske reakcije, včasih hude, s simptomi, ki vključujejo dvignjen srbeč izpuščaj, oteklost obraza ali ust (angioedem), ki povzroči težave z dihanjem in nenaden padec krvnega tlaka,
If the first infusion was completed without a severe adverse reaction, the remaining infusions of 1000 mg should be administered over 4 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below.
Če je bila prva infuzija dokončana brez hudih neželenih reakcij, je treba preostale infuzije po 1.000 mg dati v 4 urah (glejte poglavje 4.2) po periferni liniji ali stalnem katetru in po naslednjem časovnem razporedu.
• Withdraw 50 ml of ofatumumab from each of the two 1000 mg vials and inject into the 1000 ml bag;
• Potegnite 50 ml ofatumumaba iz vsake od obeh vial s 1.000 mg in ga injicirajte v 1.000-ml
Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 50 ml of concentrate for solution for infusion.
Viala iz prozornega stekla tipa I z zamaškom iz brombutilne gume in s prekrivno zaporo iz aluminija; viala vsebuje 50 ml koncentrata za raztopino za infundiranje.
Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 5 ml of concentrate for solution for infusion.
Viala iz prozornega stekla tipa I z zamaškom iz brombutilne gume in s prekrivno zaporo iz aluminija; viala vsebuje 5 ml koncentrata za raztopino za infundiranje.
Arzerra 100 mg concentrate for solution for infusion Arzerra 1000 mg concentrate for solution for infusion ofatumumab
Arzerra 100 mg koncentrat za raztopino za infundiranje Arzerra 1000 mg koncentrat za raztopino za infundiranje ofatumumab
Very common side effects These may affect more than 1 in 10 people:
Pogosti neželeni učinki Pojavijo se lahko pri največ 1 od 10 oseb:
Concentrate for solution for infusion.
Koncentrat za raztopino za infundiranje
These reactions may result in temporary interruption or withdrawal of treatment.
Ofatumumab, ki se daje intravensko, je bil povezan z reakcijami, ki so povezane z infundiranjem in lahko povzročijo začasno ali dokončno prekinitev zdravljenja.
3) How to administer the diluted solution
3) Dajanje razredčene raztopine
Dose modification and reinitiation of therapy after infusion-related ADRs In the event of a mild or moderate ADR, the infusion should be interrupted and restarted at half of the infusion rate at the time of interruption once the patient's condition is stable.
V primeru blagega ali zmernega neželenega učinka je treba infundiranje prekiniti in ga po tem, ko se bolnikovo stanje stabilizira, znova začeti s polovično hitrostjo infundiranja v času prekinitve.
Complete resolution of constitutional symptoms (fever, night sweats, fatigue, weight loss) defined as the presence of any symptoms at baseline, followed by no symptoms present.
Pri bolnikih z manjkajočimi izhodiščnimi podatki so bili na izhodišče preneseni zadnji presejalni podatki/podatki dobljeni zunaj časovnega b Popolno izginotje simptomov (zvišane telesne temperature, nočnega znojenja, utrujenosti, hujšanja), opredeljeno kot prisotnost kateregakoli simptoma izhodiščno, ki mu je sledila c Limfadenopatija, merjena z vsoto zmnožkov največjih premerov (SPD), ocenjenih s
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE
Sepsis (including neutropenic sepsis and septic shock) herpes viral infection, urinary tract
Infekcijske in parazitske bolezni okužbe spodnjih dihal (vključno s sepsa (vključno z nevtropenično sepso in septičnim šokom),
If the second infusion was completed without a severe adverse reaction, the remaining infusions (3-12) should be administered over 4 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below.
Če se je drugo infundiranje končalo brez hude reakcije, je treba preostale infuzije (3-12) dati v 4 urah (glejte poglavje 4.2) po perifernem kanalu ali stalnem katetru in po naslednjem časovnem razporedu.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja urtikarija*, srbenje*,
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 were enrolled into the study and 91% had an ECOG performance status of 0 or 1.
93 % bolnikov je imelo oceno stanja zmogljivosti ECOG 0 ali 1.
• feeling sick (nausea)
• siljenje na bruhanje (navzea),
Arzerra 1000 mg concentrate for solution for infusion
Arzerra 1000 mg koncentrat za raztopino za infundiranje
Arzerra should be discontinued in patients who experience serious or life-threatening cardiac arrhythmias.
Če se pri bolniku pojavijo resne ali smrtno nevarne motnje srčnega ritma, je treba uporabo zdravila Arzerra prekiniti.
If any infusion-related adverse reactions are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2 for further information).
Če pride do kakršnih koli neželenih učinkov, povezanih z infundiranjem, je treba infundiranje prekiniti in ga znova začeti, ko je bolnikovo stanje stabilno (za več informacij glejte poglavje 4.2).
Cytopenias, including prolonged and late-onset neutropenia, have been reported during ofatumumab therapy.
Med zdravljenjem z ofatumumabom so bile opisane citopenije, vključno z dolgotrajno in pozno nastalo nevtropenijo.
Arzerra 100 mg concentrate for solution for infusion
Arzerra 100 mg koncentrat za raztopino za infundiranje
Arzerra 1000 mg concentrate for solution for infusion ofatumumab
Arzerra 1000 mg koncentrat za raztopino za infundiranje ofatumumab
If the first infusion was completed without a severe adverse reaction, the remaining infusions of 1000 mg should be administered over 4 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below.
Če je bila prva infuzija dokončana brez hudih neželenih reakcij, je treba preostale infuzije po 1.000 mg dati v 4 urah (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila) po periferni liniji ali stalnem katetru in po naslednjem časovnem razporedu.
Arzerra 100 mg concentrate for solution for infusion ofatumumab
Arzerra 100 mg koncentrat za raztopino za infundiranje ofatumumab
Check the Arzerra concentrate for particulate matter and discolouration prior to dilution.
Pred redčenjem morate preveriti, da koncentrat zdravila Arzerra ne vsebuje delcev in ni obarvan.
• Withdraw and discard 100 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
• Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 100 ml
• Withdraw and discard 15 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
• Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 15 ml
Refractory CLL
Refraktarna KLL
If any infusion-related ADRs are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2).
Če pride do kakršnihkoli z infundiranjem povezanih neželenih učinkov zdravila, je treba infundiranje prekiniti in ga znova začeti, ko je bolnikovo stanje stabilno (glejte poglavje 4.2).
For the first and second infusion, administer over 6.5 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below:
Prvo in drugo infundiranje zdravila morata trajati 6,5 ure (glejte poglavje 4.2); infuziji je treba dati po perifernem kanalu ali stalnem katetru in po naslednjem časovnem razporedu:
ORR (%) 95% CI P value p<0.001
Vrednost p p < 0,001
• Withdraw and discard 50 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
• Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 50 ml
For the first infusion, administer over 4.5 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below:
Prvo infuzijo je treba dati v 4,5 ure (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila) po periferni liniji ali stalnem katetru in po naslednjem časovnem razporedu:
(Primary) endpoint
(Primarni) opazovani dogodek
Ask your doctor for advice if you are planning to become pregnant after this period.
Če želite po tem obdobju zanositi, se posvetujte z zdravnikom.
Chlorambuci + Chl
Limfadenopatija c
Small intestinal obstruction
• mišični krči.
Immune system disorders
Redčenje raztopine za infundiranje
Chlorambucil
Zapora črevesa
If any infusion-related adverse reactions are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2 of the SmPC).
Če pride do kakršnih koli neželenih učinkov, povezanih z infundiranjem, je treba infundiranje prekiniti in ga znova začeti, ko je bolnikovo stanje stabilno (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila).
For the first and second infusion, administer over 6.5 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below:
Prvo in drugo infundiranje zdravila morata trajati 6,5 ure (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila); infuziji je treba dati po perifernem kanalu ali stalnem katetru in po naslednjem časovnem razporedu:
All responses were confirmed after 4 weeks.
Vsi odzivi so bili potrjeni po 4 tednih.
31 May 2022
31. maj 2022
It should only be used, if other medicinal products are not efficacious.
Uporablja se lahko le, če druga zdravila niso učinkovita.
No additional deaths or transformations occurred in the ITT population.
V populaciji ITT ni prišlo do dodatnih smrti ali transformacij.
Date of first authorisation: 27 March 2013 Date of latest renewal: 18 February 2019
Datum prve odobritve: 27. marec 2013 Datum zadnjega podaljšanja: 18. februar 2019
2 patients had more than 1 mutation in this category.
2 bolnika sta imela več kot eno mutacijo v tej kategoriji.
No formal studies have been performed to assess the effects of these demographic factors.
Formalnih študij, ki bi ocenile vpliv teh demografskih faktorjev, niso opravili.
The safety analyses included data from an ongoing extension study.
Analize varnosti so vključevale podatke iz potekajoče podaljšane študije.
The efficacy results are summarised in Table 3.
Rezultati učinkovitosti so povzeti v preglednici 3.
Therefore, clinical activity in patients with these mutations is not expected.
Klinične aktivnosti pri bolnikih s temi mutacijami torej ni pričakovati.
Seventy-five percent of the dose was recovered within 96 hours.
Petinsedemdeset odstotkov odmerka se je izločilo v 96 urah.
Final Clinical Study Report:
Končno poročilo o klinični študiji:
Do not take a double dose to make up for the forgotten tablets.
Ne vzemite dvojnega odmerka, da bi nadomestili pozabljene tablete.
This is always important, but especially if you are experiencing frequent or prolonged diarrhoea as described above.
To je vedno pomembno, še zlasti pa, če imate pogoste in dolgotrajne driske, kot je opisano zgoraj.
Take the tablet(s) in the morning with food.
Tableto (tablete) vzemite zjutraj skupaj s hrano.
A potential risk to the breast-feeding infant cannot be excluded.
Možnega tveganja za dojenega otroka ne moremo izključiti.
Note: Percentages were based on number of patients in each treatment group.
Opomba: Odstotki temeljijo na številu bolnikov v vsaki skupini zdravljenja.
Concentration of radioactivity in milk was up to 8-fold higher than in plasma.
Koncentracija radioaktivnosti v mleku je bila do 8-krat večja kot v plazmi.
* For efficacy results in the subgroup of patients corresponding to the approved indication, see text above.
* Za rezultate učinkovitosti pri podskupini bolnikov, zajeti v odobreni indikaciji, glejte besedilo zgoraj.
ANC = absolute neutrophil count
ANC = absolutno število nevtrofilcev (Absolute Neutrophil Count)
The presence of hypokalaemia and hypomagnesaemia may further enhance this effect.
Prisotnost hipokaliemije in hipomagneziemije lahko ta učinek še okrepi.
- if you have an infection.
- Če imate okužbo.
Patients should be monitored and managed using standard-of-care treatment.
Bolnike je treba spremljati in obravnavati z uporabo standardnega zdravljenja.
When your disease is very severe, your body may not be able to clear all the waste products from the dying cancer cells.
Če je vaša bolezen zelo huda, vaše telo morda ni sposobno odstraniti vseh odpadnih snovi propadajočih rakavih celic.
9/L and less than 1.0×10
9/l in manjše od 1,0 x 10
Age, gender and race
Starost, spol in rasa
Since there is limited information in the elderly, caution should be exercised in these patients.
Ker so podatki glede uporabe pri starejših omejeni, je pri teh bolnikih potrebna previdnost.
Your doctor will be aware of this and may ensure you are adequately hydrated and give you other medicines to help prevent it.
Zdravnik je s tem seznanjen in lahko zagotovi, da ste ustrezno hidrirani, ter vam da druga zdravila za preprečevanje tega sindroma.
Some medicines can affect the levels of Bosulif in your body.
Nekatera zdravila lahko vplivajo na raven zdravila Bosulif v vašem telesu.
Number (%) of subjects with MMR
čas število (%) preskušancev z MMR
Women of childbearing potential/Contraception
Ženske v rodni dobi/kontracepcija