CYMEVENE

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Unit dalam paket:

DUS, 1 VIAL @ 500 MG

Tanggal Otorisasi:

2022-05-09

Karakteristik produk

Page 1 of 16
CYMEVENE
®
for Intravenous infusion
1.
DESCRIPTION
1.1
Therapeutic/Pharmacologic Class of Drug
Antiviral
ATC code: J05AB06
1.2
Type of Dosage Form
Powder for concentrate for solution for infusion.
1.3
Route of Administration
Intravenous (IV) infusion.
1.4
Sterile/Radioactive Statement
Sterile product.
1.5
Qualitative and Quantitative Composition
Active ingredient: ganciclovir in the form of sodium salt
Each vial of Cymevene contains 543 mg of sterile, freeze-dried
ganciclovir sodium equivalent to 500 mg
ganciclovir as a white to off-white powder. Reconstitution with 10 mL
of sterile Water for Injections BP
gives a ganciclovir concentration of 50 mg/mL, pH 11. Further dilution
in an appropriate intravenous
solution
must
be
performed
before
infusion
(see
2.2
Dosage
and
Administration,
Method
of
Administration).
2.
CLINICAL PARTICULARS
2.1
Therapeutic Indication(s)
Cymevene is indicated for the treatment of life-threatening or
sight-threatening cytomegalovirus (CMV)
infections in immunocompromised individuals. These states include
acquired immunodeficiency syndrome
(AIDS),
iatrogenic
immunosuppression
associated
with
organ
transplantation,
or
chemotherapy
for
neoplasia.
Cymevene may also be used for the prevention of CMV disease,
specifically in those patients receiving
immunosuppressive therapy secondary to organ transplantation.
2.2
Dosage and Administration
Treatment of CMV Infection
Initial (Induction) Treatment. 5 mg/kg infused at a constant rate over
1 hour every 12 hours (10
mg/kg/day) for 14 to 21 days.
Long –term (Maintenance) treatment. For immunocompromised patients
at risk of relapse of CMV retinitis
a course of maintenance therapy may be given. Intravenous infusion of
6 mg/kg daily 5 days per week, or
5 mg/kg daily 7 days per week is recommended.
Treatment of Disease Progression. Indefinite treatment may be required
in patients with AIDS, but event
with continued maintenance treatment, patients may have progression of
retinitis. Any patient in whom the
retinitis progresses, either while