Примери за използване на To clofarabine на Английски и техните преводи на Български
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These events were considered to be related to clofarabine in 11 patients.
Hypersensitivity to clofarabine or to any of the excipients(see section 6.1).
Nearly all patients(98%) experienced at least one adverse event considered by the study investigator to be related to clofarabine.
The majority of patients who respond to clofarabine achieve a response after 1 or 2 treatment cycles(see section 5.1).
One hundred and twenty nine patients(98% of the total population)experienced at least one adverse event considered by the study investigator to be related to clofarabine.
The majority of patients who respond to clofarabine achieve a response after 1 or 2 treatment cycles(see section 5.1).
One patient discontinued treatment due to grade 4 hyperbilirubinaemia considered as related to clofarabine after receiving 52 mg/m2/day clofarabine.
Adverse reactions considered to be related to clofarabine reported at frequencies≥ 1/1,000(i.e. in> 1/115 patients) in clinical trials and post-marketing.
Evoltra should not be used in people who may be hypersensitive(allergic) to clofarabine or any of the other ingredients.
Adverse events considered to be related to clofarabine reported at frequencies≥ 1/ 100(i. e. in> 1/ 132 patients) in clinical trials(Very common=≥ 1/ 10; Common=≥ 1/ 100 to< 1/ 10) Infections and infestations.
Increased ALT and increased AST were reported as an adverse event on 2 occasions each and increased blood bilirubin was reported as an adverse event on 1 occasion;all 5 events were considered to be severe and related to clofarabine.
Three of these events were subsequently assessed as being related to clofarabine: pericardial effusion(2 events; 1 of which was serious) and pericarditis(1 event; not serious).
In addition, 9/ 132 patients receiving clofarabine had at least severely elevated creatinine(at least US NCI CTC Grade 3 elevated creatinine)and increased blood creatinine was reported as an adverse event that was not related to clofarabine on 2 occasions(see sections 4.3 and 4.4).
These events were all subsequently assessed as being related to clofarabine: pericardial effusion(9 events; 1 of which was serious) and pericarditis(1 event; not serious).
Six events were considered to be related to clofarabine of which acute cholecystitis(1 event), cholelithiasis(1 event), hepatocellular damage(1 event; patient died(see above)) and hyperbilirubinaemia(1 event; the patient discontinued therapy(see above)) were considered to be serious.
Five adverse events in 4/ 132 patients were considered to be related to clofarabine, none of which were serious; haematuria(4 events) and acute renal failure(1 event).
Fourteen events in 10/ 132 patients were considered to be related to clofarabine of which acute cholecystitis(1 event), cholelithiasis(1 event), hepatocellular damage(1 event; patient died(see above)) and hyperbilirubinaemia(2 events; patients discontinued therapy(see above)) were considered to be serious.
Fifteen events in 12/ 132 patients were considered to be related to clofarabine, none of which were serious and the most frequently reported being tachycardia(7 events; see section 4.4).
Eleven events in 115 patients were considered to be related to clofarabine, none of which were serious and the most frequently reported cardiac disorder was tachycardia(35%)(see section 4.4); 6.1%(7/115) patient's tachycardia were considered to be related to clofarabine.
Four renal adverse events in 115 patients were considered to be related to clofarabine, none of which were serious; haematuria(3 events) and acute renal failure(1 event)(see sections 4.3 and 4.4).
Twenty-one(18.3%) events were considered to be related to clofarabine of which catheter related infection(1 event), sepsis(2 events) and septic shock(2 events; 1 patient died(see above)) were considered to be serious.
Thirty nine events in 22/ 132 patients were considered to be related to clofarabine of which implant infection(1 event), sepsis(1 event) and septic shock(2 events; 1 patient died(see above)) were considered to be serious.
Twenty six events in 24/ 132 patients were considered to be related to clofarabine, the most frequently reported being flushing(15 events; not serious) and hypotension(5 events; one of which was considered to be serious; see section 4.4).
Twenty-three patients out of 115 experienced a vascular disorder considered to be related to clofarabine, the most frequently reported being flushing(13 events; not serious) and hypotension(5 events; all of which were considered to be serious; see section 4.4).
Clofarabine may cause harm to unborn babies when used by pregnant women.
ALT and AST occurred within 10 days of clofarabine administration and returned to≤ grade 2 within 15 days.
The majority ofelevations in ALT and AST occurred within 10 days of clofarabine administration and returned to grade 2 within 15 days.
Population pharmacokinetic data from adult and paediatric patients suggest that patients with stable moderate renal impairment(creatinine clearance 30-< 60 ml/min)receiving a 50% dose reduction achieve similar clofarabine exposure to those with normal renal function receiving a standard dose.
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.
In addition, clofarabine possesses greater resistance to cellular degradation by adenosine deaminase anddecreased susceptibility to phosphorolytic cleavage than other active substances in its class whilst the affinity of clofarabine triphosphate for DNA polymerase and ribonucleotide reductase is similar to or greater than that of deoxyadenosine triphosphate.