Parecoxib Juno

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Parecoxib sodium 42.36mg equivalent to to parecoxib 40mg

Հասանելի է:

Juno Pharmaceuticals NZ Limited

Դոզան:

40 mg

Դեղագործական ձեւ:

Powder for injection

Կազմը:

Active: Parecoxib sodium 42.36mg equivalent to to parecoxib 40mg Excipient: Dibasic sodium phosphate Phosphoric acid Sodium hydroxide

Ռեկվիզորի տեսակը:

Prescription

Թերապեւտիկ ցուցումներ:

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

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Vial, glass, Type 1, clear, 5mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours reconstituted (not refrigerated) stored at or below 25°C

Հաստատման ամսաթիվը:

2017-12-05

Տեղեկատվական թերթիկ

1
PARECOXIB JUNO POWDER FOR INJECTION
_parecoxib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
Parecoxib
Juno
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 Juno 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 JUNO IS
USED FOR
_WHAT PARECOXIB JUNO 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 Juno 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 JUNO WORKS_
This medicine belongs to a group of
medicines called Coxibs.
These medicines work by relieving
pain and inflammation.
_USING PARECOXIB JUNO_
Parecoxib Juno 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 JUNO
_WHEN IT MUST NOT BE USED_
YOU MUST NOT BE GIVEN PARECOXIB
JUNO 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
Juno
may
include:
•
asthma, wheezing

Ապրանքի հատկությունները

PARECOXIB JUNO Datasheet v2.0
1 of 26
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
PARECOXIB JUNO 40mg Powder for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PARECOXIB JUNO 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 JUNO Datasheet v2.0
2 of 26
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, the recommended dose of pareco