Qilu DECITABINE LYOPHILISED POWDER FOR INFUSION 50 MGVIAL

দেশ: মাল্যাশিয়া

ভাষা: ইংরেজি

সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

সক্রিয় উপাদান:

DECITABINE

থেকে পাওয়া:

MEDISPEC (M) SDN.BHD

INN (আন্তর্জাতিক নাম):

DECITABINE

প্যাকেজ ইউনিট:

1 Vials

Manufactured by:

Qilu Pharmaceutical (Hainan) Co., Ltd.

পণ্য বৈশিষ্ট্য

QILU DECITABINE LYOPHILISED POWDER FOR INFUSION 50 MG/VIAL
DOSAGE FORMS AND STRENGTHS
White to almost white lyophilized powder in 20ml type 1 glass vial.
Decitabine for Injection is aseptically reconstituted with Sterile
Water for Injection. The reconstituted
solution is clear and colorless.
The reconstituted solution should be diluted with 0.9% Sodium Chloride
Injection or 5% Dextrose
Injection. The diluted solution is clear and colorless.
List of diluents: Sterile Water for Injection, 0.9% Sodium Chloride
Injection or 5% Dextrose Injection.
CLINICAL INFORMATION
INDICATIONS
Qilu DECITABINE LYOPHILISED POWDER FOR INFUSION 50 MG/VIAL is
indicated for treatment
of adult patients with myelodysplastic syndromes (MDS) including
previously treated and untreated, de
novo and secondary MDS of all FrenchAmerican-British subtypes
(refractory anemia, refractory anemia
with ringed sideroblasts, refractory anemia with excess blasts,
refractory anemia with excess blasts in
transformation, and chronic myelomonocytic leukemia) and
intermediate-1, intermediate-2, and high-risk
International Prognostic Scoring System groups.
Qilu DECITABINE LYOPHILISED POWDER FOR INFUSION 50 MG/VIAL is
indicated for the
treatment of adult patients aged 65 and above with newly diagnosed de
novo or secondary acute myeloid
leukemia (AML), according to the World Health Organization (WHO)
classification, who are not
candidates for standard induction chemotherapy
DOSAGE AND ADMINISTRATION
Qilu Decitabine administration must be initiated under the supervision
of physicians experienced in the
use of chemotherapeutic medicinal products.
TREATMENT REGIMEN IN MYELODYSPLASTIC SYNDROMES (MDS)
PRE-MEDICATIONS AND BASELINE TESTING
• Consider pre-medicating for nausea with antiemetics.
• Conduct baseline laboratory testing: complete blood count (CBC)
with platelets, serum hepatic panel,
and serum creatinine.
Qilu Decitabine Regimen Options
_Three Day Regimen _
Administer Qilu Decitabine at a dose of 15 mg/m
2
by continuous intravenous infusion over 3 hours
re