PARECOXB parecoxib (as sodium) 40mg powder for solution for injection

Երկիր: Մալայզիա

Լեզու: անգլերեն

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

Ակտիվ բաղադրիչ:

PARECOXIB SODIUM

Հասանելի է:

UNIMED SDN BHD

INN (Միջազգային անվանումը):

PARECOXIB SODIUM

Միավորները փաթեթում:

5 Units; 10 Units; 5 Units; 10 Units

Պատրաստված է:

ANFARM HELLAS S.A.

Ապրանքի հատկությունները

PRODUCT INFORMATION
PARECOXB PARECOXIB (AS SODIUM)
NAME OF THE MEDICINE
PARECOXB parecoxib (as sodium) 40 mg powder for solution for
injection.
The following structural formula of parecoxib sodium is shown below:
Chemical
name:
N-[[4-(5-methyl-3-phenyl-4
isoxazolyl)
phenyl]sulfonyl]
propanamide, sodium salt
Molecular formula:
C
19
H
17
N
2
O
4
SNa
Molecular weight:
392.41
CAS number:
198470-85-8
DESCRIPTION
Parecoxib sodium is a white to off-white solid that is very soluble in
water. The
formulated drug product is soluble in normal (0.9%) saline at >50
mg/mL.
Powder for Injection and Powder and Diluent for Injection
PARECOXB Injection is a white to off-white, preservative-free,
lyophilised powder
in a single-use vial. For intravenous (IV) or intramuscular (IM)
administration,
PARECOXB Injection should be reconstituted with 2 mL sodium chloride
solution
(0.9% w/v), or a suitable alternative (see DOSAGE AND ADMINISTRATION).
Reconstituted Solution
The reconstituted solution is clear and colourless.
PARECOXB Injection 40 mg contains parecoxib sodium, sodium
phosphate-dibasic
anhydrous; phosphoric acid and/or sodium hydroxide may have been added
to adjust pH.
When reconstituted in sodium chloride solution (0.9% w/v), PARECOXB
Injection
contains approximately 0.44 mEq of sodium per 40 mg vial.
PHARMACOLOGY
Pharmacological Actions
PHARMACODYNAMICS
Following injection, parecoxib sodium is rapidly converted to
valdecoxib: the _in vivo _
pharmacology of parecoxib is therefore that of valdecoxib. The
mechanism of action
of valdecoxib is by inhibition of cyclooxygenase-2 (COX-2)-mediated
prostaglandin
synthesis. At therapeutic plasma concentrations in humans, valdecoxib
does not
inhibit cyclooxygenase-1 (COX-1). In animal models, valdecoxib is
anti-inflammatory,
analgesic, and antipyretic.
By inhibition of both peripheral and central COX-2, valdecoxib reduces
the production
of prostaglandins that are important mediators of pain and
inflammation. Therefore,
PARECOXB Injection is not expected to exhibit the potential for
depen