KEMOPLAT INJECTION 1MGML

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CISPLATIN/ CISPLATINUM

Boleh didapati daripada:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (Nama Antarabangsa):

CISPLATIN/ CISPLATINUM

Unit dalam pakej:

1x50 ml

Dikeluarkan oleh:

Fresenius Kabi Oncology Limited

Ciri produk

KEMOPLAT INJ. - PIL - MYS - BADDI-2
Font: Times New Roman
Dimension: 350x280 mm
Folding Size: 35x35 mm
_(Outline of folding size for indication_
_ _
_purpose only, it should be removed_
_ _
_before final printing.)_
Font Size: 10 Pt
22 Nov. 2018 Version: 02
Final Packaging Site: Baddi-II
Mfg. Site: Baddi-II
BLACK
Form No.: SOP/PDD/014-02 Rev. 00
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Countries\Malaysia\Baddi-2\Kemoplat\2018 October\Kemoplat Inj. - PIL -
MYS - Baddi-2.indd
For the use only of a Registered Medical Practitioner
or a Hospital or a Laboratory
KEMOPLAT INJECTION 1 MG/ML
KEMOPLAT
DESCRIPTION
Cisplatin is a cell cycle-phase nonspecific anti-neoplastic agent used
as an
adjunct in the treatment of a wide variety of tumours. Cisplatin is an
inorganic
compound closely related to alkylating agents such as
cyclophosphamide.
Cisplatin and Carboplatin have identical mechanism of action and
differ only
in their structures and toxicities. KEMOPLAT (Cisplatin Injection) is
a clear,
colourless solution.
COMPOSITION
KEMOPLAT (Cisplatin Injection 0.5 mg/ml)
Each ml contains:
Cisplatin USP 0.5 mg
Sodium
Chloride
USP
9
mg
Hydrochloric Acid USNF
q.s. to adjust pH
Water for injection USP q.s.
KEMOPLAT (Cisplatin Injection 1.0 mg/ml)
Each ml contains:
Cisplatin USP 1.0 mg
Sodium
Chloride
USP
9
mg
Hydrochloric Acid USNF q.s. to adjust pH
Water for injection USP q.s.
CHEMICAL STRUCTURE
Cisplatin is a heavy metal platinum co-ordination complex containing a
central atom of platinum surrounded by two entities each of two
chloride
ions and two ammonia molecules in Cis-geometry. Chemically, it is a
cis
isomer of diamminedichloroplatinum (II). It has a melting point of
207°C.
elimination is biphasic with half-lives of 25-49 minutes (Phase-I) and
58-73
hour (Phase-II), respectively. Cisplatin is eliminated via the urine
(27 to 43%)
of the administered dose is excreted in the urine during the first
five days after
administration.
DRUG INTERACTIONS
3,4
•
Potentially nephrotoxic or ototoxic drugs, e.g. aminoglycoside,
antibioti