Parecoxib

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Parecoxib sodium 42.36mg equivalent to to parecoxib 40mg

Available from:

Juno Pharmaceuticals NZ Limited

Dosage:

40 mg

Pharmaceutical form:

Powder for injection with diluent

Composition:

Active: Parecoxib sodium 42.36mg equivalent to to parecoxib 40mg Excipient: Dibasic sodium phosphate Sodium chloride Water for injection

Prescription type:

Prescription

Therapeutic indications:

For a single peri-operative dose for the management of post-operative pain.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type 1 clear 2 mL, diluent - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Combination pack, 1x glass vial (active) + 1x glass ampoule (diluent, 2mL) - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted (not refrigerated) stored at or below 25°C protect from light - Combination pack, 3x glass vial (active) + 3x glass ampoule (diluent, 2 mL) - 3 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted (not refrigerated) stored at or below 25°C protect from light - Combination pack, 5x glass vial (active) + 5x glass ampoule (diluent, 2mL) - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted (not refrigerated) stored at or below 25°C protect from light - Vial, glass, Type 1 clear, active - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted (not refrigerated) stored at or below 25°C protect from light

Authorization date:

2018-10-29

Summary of Product characteristics

PARECOXIB (NEO HEALTH) Datasheet v1.0
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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
PARECOXIB (NEO HEALTH) 40mg Powder for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PARECOXIB (NEO HEALTH) injection contains 40 mg parecoxib (as 42.36 mg
parecoxib
sodium). 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. After
reconstitution, the concentration of parecoxib is 20 mg/mL.
EXCIPIENT(S) WITH KNOWN EFFECT
When reconstituted in sodium chloride solution (0.9% w/v), parecoxib
injection contains
approximately 0.44 mEq of sodium per 40 mg vial.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
POWDER FOR INJECTION
Parecoxib injection is a white to off-white, preservative-free,
lyophilised powder in a single-use
vial. For intravenous (IV) or intramuscular (IM) administration,
parecoxib injection should be
reconstituted with 2 mL sodium chloride solution (0.9% w/v), or a
suitable alternative (see
section 4.2).
DILUENT FOR INJECTION
Parecoxib injection may be supplied with a 2 mL capacity diluent
ampoule with a fill volume
of 2 mL Sodium Chloride Intravenous Infusion (0.9% w/v) BP.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For a single peri-operative dose for the management of post-operative
pain.
PARECOXIB (NEO HEALTH) Datasheet v1.0
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The decision to prescribe parecoxib should be based on an assessment
of the individual patient's
overall risks and the potential risk/benefit profile of alternative
parenteral therapies.
As the cardiovascular risks of the selective COX-2 inhibitors may
increase with dose and
duration of exposure, the shortest duration possible and the lowest
effective daily dose should
be used.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
The usual recommended dose is a single 40 mg dose administered
intravenously (IV) or
intramuscularly (IM).
_Elderly _
No dosage adjustment is generally necessary. However, for elderly
female patients weighing
less than 50 kg