PARECOXIB JUNO parecoxib (as sodium) 40 mg powder for injection vial with diluent

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

parecoxib sodium, Quantity: 42.36 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: phosphoric acid; dibasic sodium phosphate; sodium hydroxide

Administration route:

Intramuscular, Intravenous

Units in package:

1 vial & 1 ampoule, 3 vials & 3 ampoules, 5 vials & 5 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: White to off-white, lyophilized powder in a single use vial.; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-04-04

Patient Information leaflet

1
PARECOXIB JPL POWDER FOR INJECTION
_parecoxib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
Parecoxib
JPL
powder for injection.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or nurse.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
being
given
Parecoxib JPL against the benefits
they expect it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
USING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR NURSE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PARECOXIB JPL IS
USED FOR
_WHAT PARECOXIB JPL IS FOR_
This
medicine
is
used
for
the
prevention and treatment of pain. It
can
be
used
to
relieve
pain
and
reduce inflammation (swelling and
soreness)
which
may
occur
after
surgery.
Although Parecoxib JPL can relieve
the
symptoms
of
pain
and
inflammation, it will not cure your
condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
_HOW PARECOXIB JPL WORKS_
This medicine belongs to a group of
medicines called Coxibs.
These medicines work by relieving
pain and inflammation.
_USING PARECOXIB JPL_
Parecoxib JPL is an injection. Only
a
doctor
or
nurse
can
give
the
injection.
This
medicine
is
available
only
with a doctor's prescription.
This medicine is not addictive.
_USE IN CHILDREN_
There is not enough information to
recommend the use of this medicine
in children.
BEFORE YOU ARE GIVEN
PARECOXIB JPL
_WHEN IT MUST NOT BE USED_
YOU MUST NOT BE GIVEN PARECOXIB
JPL IF YOU HAVE AN ALLERGY TO:
•
parecoxib sodium or valdecoxib
•
any of the ingredients listed at the
end of this leaflet
•
sulphonamides,
a
group
of
medicines
which
include,
for
example,
certain
antibiotics
(if
you are not sure whether you are
taking one of these medicines ask
your doctor or nurse).
Some of the symptoms of an allergic
reaction
to
Parecoxib
JPL
may
include:
•
asthma, wheezing or shortnes

Summary of Product characteristics

Australian Product Information
PI v 1.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION-
PARECOXIB JUNO
_(PARECOXIB (AS SODIUM) WITH DILUENT)_
_ _
_ _
1 NAME OF THE MEDICINE
Parecoxib Juno contains parecoxib (as sodium).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Parecoxib Juno Injection is a white to off-white, preservative-free,
lyophilised powder in a
single-use vial. For intravenous (IV) or intramuscular (IM)
administration, Parecoxib Juno
Injection should be reconstituted with 2 mL sodium chloride solution
(0.9% w/v), or a suitable
alternative (see SECTION 4.2, DOSE AND METHOD OF ADMINISTRATION)
DILUENT FOR INJECTION
Parecoxib Juno Injection is supplied with a 2 mL capacity diluent
ampoule with a fill volume
of 2 mL Sodium Chloride Intravenous Infusion (0.9% w/v) BP.
RECONSTITUTED SOLUTION
The reconstituted solution is clear and colourless.
Parecoxib Juno Injection 40 mg contains parecoxib sodium, dibasic
sodium phosphate;
phosphoric acid and/or sodium hydroxide may have been added to adjust
pH.
When reconstituted in sodium chloride solution (0.9% w/v), Parecoxib
Juno Injection contains
approximately 0.44 mEq of sodium per 40 mg vial.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Parecoxib powder for injection is a white to off-white,
preservative-free, lyophilised powder in
a single-use vial supplied with a clear colourless diluent in
ampoules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For a single peri-operative dose for the management of post-operative
pain.
Australian Product Information
PI v 1.0
Page | 2
4.2 DOSE AND METHOD OF ADMINISTRATION
The usual recommended dose is a single 40 mg dose administered
intravenously (IV) or
intramuscularly (IM). The IV bolus injection may be given rapidly and
directly into a vein or
into an existing IV line. The I