DYNASTAT parecoxib (as sodium) 40mg powder for injection vial

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

parecoxib sodium, Quantity: 42.36 mg (Equivalent: parecoxib, Qty 40 mg)

Saatavilla:

Pfizer Australia Pty Ltd

Lääkemuoto:

Injection, powder for

Koostumus:

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

Antoreitti:

Intravenous, Intramuscular

Kpl paketissa:

10 vials

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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

Tuoteyhteenveto:

Visual Identification: White to off-white solid in a stoppered 5mL clear glass vial (40mg). Reconstituted solution: Clear and colourless.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2002-05-30

Pakkausseloste

DYNASTAT
®
(DIE-NA-STAT)
_parecoxib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dynastat 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 Dynastat
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 DYNASTAT IS USED
FOR
_WHAT DYNASTAT 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 Dynastat 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 DYNASTAT WORKS_
This medicine belongs to a group of
medicines called Coxibs.
These medicines work by relieving
pain and inflammation.
_USING DYNASTAT_
Dynastat 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
DYNASTAT
_WHEN IT MUST NOT BE USED_
YOU MUST NOT BE GIVEN DYNASTAT 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 Dynastat may include:
•
asthma, wheezing or shortness of
breath
•
swelling of the face, lips or
tongue which may cau

Valmisteyhteenveto

Version: pfpdynav11121
Supersedes: pfpdynav10220
Page 1 of 28
AUSTRALIAN
PRODUCT
INFORMATION
–
DYNASTAT
 (PARECOXIB SODIUM)
1
NAME OF THE MEDICINE
Parecoxib 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.
Each vial of DYNASTAT Injection contains 40 mg parecoxib (as 42.36 mg
parecoxib sodium).
EXCIPIENT WITH KNOWN EFFECT
When reconstituted in sodium chloride solution (0.9% w/v), DYNASTAT
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
Powder for Injection
Powder for Injection with Diluent
DYNASTAT Injection is a white to off-white, preservative-free,
lyophilised powder in a
single-use vial.
DYNASTAT 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.
The reconstituted solution is clear and colourless.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For a single peri-operative dose for the management of post-operative
pain.
4.2
D
OSE 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 IM injection should be given slowly and
deeply into the muscle.
For intravenous (IV) or intramuscular (IM) administration, DYNASTAT
Injection should be
reconstituted with 2 mL sodium chloride solution (0.9% w/v), or a
suitable alternative.
Version: pfpdynav11121
Supersedes: pfpdynav10220
Page 2 of 28
Reconstitute DYNASTAT Injection with 2 mL sodium chloride solution
(0.9% w/v) using
aseptic technique. The
ONLY
other acceptable diluents for reconstitution are:
•
5% Glucose Intravenous Infusion
•
0.45% Sodium Chloride and 5% Glucose Injection.
Use of Sterile Water for Injections is
NOT
rec