prekid doziranja
prekid doze
Dose reductions and/or dose interruptions may be needed to manage adverse events.
Za tretman nuspojava možda će biti potrebno smanjiti i/ili prekinuti dozu.Management of neurotoxicity including dose adjustment and dose interruption.
Zbrinjavanje neurotoksičnosti uključujući prilagodbu doze i privremeni prekid doziranja.Temporary dose interruption until recovery to Grade2(≥1.25x109/l) and no fever.
Privremeni prekid primjene do oporavka do stupnja 2(≥1,25x109/l) i povlačenja vrućice.If toxicity becomes intolerable,temporary dose interruption until recovery to Grade1.
Ako toksičnost postane nepodnošljiva,privremeno prekinuti primjenu do oporavka do stupnja 1.Dose interruptions may be required based on individual safety and tolerability.
Ovisno o sigurnosti i podnošljivosti lijeka u pojedinog bolesnika, možda će biti potrebni privremeni prekidi doziranja.In one case,this resulted in subclinical hepatitis which resolved after a dose interruption. Dose interruption and dose reduction should be employed as necessary see sections 4.2 and 4.8.
Prekid doziranja i smanjivanje doze treba primjenjivati prema potrebi vidjeti dijelove 4.2 i 4.8.The median time to first dose reduction was 43 days,and to first dose interruption was 33 days.
Medijan vremena do prvog smanjenja dozeiznosio je 43 dana, a do prvog prekida doze 33 dana.Dose interruption may become necessary in patients who experience worsening of liver function see section 4.2.
Prekid doze može biti potreban kod bolesnika u kojih dođe do pogoršanja jetrene funkcije vidjeti dio 4.2.In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption.
U preostale trećine bolesnika povišene vrijednosti serumskog kreatinina nisu uvijek reagirale na smanjenje doze ni prekid doziranja.Dose interruptions occurred in 202 patients(54%) on sunitinib and 141 patients(39%) on IFN-α.
Do privremenog prekida primjene lijeka došlo je u 202 bolesnika(54%) liječena sunitinibom i 141 bolesnika(39%) liječenog IFN-α.Observed cases were generally associated with pyrexia and dehydration andresponded well to dose interruption and general supportive measures.
Primijećeni slučajevi bili su općenito povezani s pireksijom i dehidracijom, tesu dobro reagirali na prekid doziranja i opće potporne mjere.Dose interruptions and/or dose reductions may be required based on individual safety and tolerability.
Prekidi primjene i/ili smanjenja doze mogu biti potrebni ovisno o sigurnosti i podnošljivosti lijeka u pojedinog bolesnika.The majority of these cases were Grade 1 or 2 anddid not require any dose interruptions or dose reductions see sections 4.2 and 4.4.
Većina tih slučajeva bila je 1. ili 2. stupnja inije zahtijevala privremeni prekid primjene niti smanjenje doze vidjeti dijelove 4.2 i 4.4.Table 2- Dose interruption and resumption criteria for haematological toxicities related to myelosuppression.
Tablica 2: Kriteriji za privremeni prekid primjene i nastavak primjene u slučaju hematološke toksičnosti povezane s mijelosupresijom.Dose reductions should be considered if the platelet count decreases below 100,000/mm3,with the goal of avoiding dose interruptions for thrombocytopenia.
Treba razmotriti smanjivanje doze ako se razina trombocita snizi na manje od 100 000/mm3, kakobi se izbjegao prekid u doziranju zbog trombocitopenije.When dose interruption is required, consider resuming Odomzo at the same dose after resolution of the adverse reaction to≤ grade 1.
Kada je potreban privremeni prekid doziranja, valja razmotriti nastavak liječenja Odomzom u istoj dozi nakon ublažavanja nuspojave do ≤ stupnja 1.Patients with serious non-infectious febrile events responded well to dose interruption and/or dose reduction and supportive care see sections 4.2 and 4.4.
Bolesnici u kojih se javila ozbiljna neinfektivna vrućica dobro su reagirali na prekid doziranja i/ili smanjenje doze i suportivnu njegu vidjeti dijelove 4.2 i 4.4.Dose reductions and dose interruptions occurred in 79% and 72%, respectively, of cabozantinib-treated patients in the pivotal clinical trial.
Smanjenje doze i prekidi doza su se javili u 79%, odnosno 72% bolesnika koji su liječeni kabozantinibom tijekom ključnog kliničkog ispitivanja.Overall, 76% of patients achieved andmaintained the target dose of Entresto 200 mg twice daily without any dose interruption or down-titration over 12 weeks.
Ukupno je 76% bolesnika postiglo iodržalo ciljnu dozu Entresta 200 mg dvaput na dan bez ikakvog prekida u doziranju ili postupno sniženje doze tijekom 12 tjedana.FN was associated with dose interruption in 3.7% of patients, and with dose reduction in 1.3% of patients, and with no treatment discontinuations.
FN je bila povezana s prekidima u doziranju u 3, 7% bolesnika i smanjenjem doze u 1, 3% bolesnika te bez prekida liječenja.Management of severe orintolerable adverse reactions may require temporary dose interruption(with or without a subsequent dose reduction) or discontinuation.
Zbrinjavanje teških ilinepodnošljivih nuspojava moglo bi zahtijevati privremeni prekid doziranja(s naknadnim smanjenjem doze ili bez njega) ili trajni prekid terapije.Table 1 summarises recommendations for dose interruption and/or dose reduction of Odomzo therapy in the management of symptomatic CK elevations and muscle-related adverse events such as myalgia, myopathy, and/or spasm.
U Tablici 1 naveden je sažetak preporuka za prekid doziranja i/ili smanjenje doze Odomza kod zbrinjavanja simptomatskih povišenja CPK i štetnih događaja povezanih s mišićima kao što su mialgija, miopatija i/ili spazam.All patients were administered 45 mg of Iclusig once-daily with the possibility of dose de-escalations and dose interruptions followed by dose resumption and re-escalation.
Svi bolesnici primili su 45 mg lijeka Iclusig jednom dnevno s mogućnosti smanjenja doze i prekida doze, a potom ponovni nastavak doziranja i povišenje doze..Overdosing signs were observed in a toxicity study conducted in healthy adult Beagle dogs treated with 2 mg/kg, 4 mg/kg or6 mg toceranib/kg once every other day for 13 consecutive weeks without dose interruption.
Simptomi predoziranja primijećeni su u studiji toksičnosti na zdravim odraslim psima pasmine Beagle koji su dobivali 2 mg/kg, 4 mg/kg ili6 mg toceraniba na kilogram po jedanput svakog drugog dana, 13 tjedana uzastopce, bez prekidanja doze.In the lenalidomide/low dose dexamethasone group, 20 patients(9.1%)underwent at least one dose interruption compared to 65 patients(29.3%) in the lenalidomide/standard dose dexamethasone arm.
U skupini lenalidomid/niska doza deksametazona, 20 bolesnika(9,1%)imalo je bar jedan prekid doze u usporedbi sa 65 bolesnika(29,3%) u skupini lenalidomid/standardna doza deksametazona.Among the dasatinib-treated patients with pleural effusion, 96% achieved a cCCyR, 82% achieved a MMR, and50% achieved a MR4.5 despite dose interruptions or dose adjustment.
Među bolesnicima s pleuralnim izljevom liječenima dasatinibom, njih 96% postiglo je cCCyR, 82% postiglo je MMR, anjih 50% postiglo je MR4, 5 unatoč privremenom prekidu primjene lijeka ili prilagodbi doze.Cases of severe drug-related colitis occurred relatively late(months) after the start of therapy, sometimes with rapid aggravation, butresolved within a few weeks with dose interruption and additional symptomatic treatment e.g., anti-inflammatory agents such as enteric budesonide.
Slučajevi teškog kolitisa povezanog s primjenom lijeka pojavljivali su se relativno kasno(mjesecima) nakon početka liječenja, ponekad s brzim pogoršanjem, alisu se povukli unutar nekoliko tjedana od prekida uzimanja uz dodatno simptomatsko liječenje npr. protuupalni lijekovi kao što je enterična formulacija budezonida.Patients≥65 years were more likely to experience SAEs and AEs leading to permanentdiscontinuation of medicinal product, dose reduction and dose interruption than those< 65 years.
U bolesnika u dobi ≥ 65 godina veća je bila vjerojatnost da će doživjeti ozbiljne štetne događaje i štetne događaje koji će dovesti do trajne obustave uzimanja lijeka,smanjenja doze i prekida doziranja nego u onih u dobi< 65 godina.Grade 3 and 4 transaminase elevations were generally reversible upon dosing interruption.
Porasti vrijednosti transaminaza stupnja 3 ili 4 općenito su bili reverzibilni nakon prekida primjene lijeka.
Results: 30,
Time: 0.0381