Dynastat

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Parecoxib sodium

Dostupné z:

Pfizer Australia Pty Ltd

Trieda:

Medicine Registered

Príbalový leták

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 using 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 whi

Súhrn charakteristických

Version: pfpdynav10213 
Supersedes: pfpdynav10912 

Page 1 of 25 
PRODUCT INFORMATION 
DYNASTAT PARECOXIB (AS SODIUM) 
NAME OF THE MEDICINE 
DYNASTAT parecoxib (as sodium) 20 mg and 40 mg Powder for
Injection. 
DYNASTAT parecoxib (as sodium) 20 mg and 40 mg Powder for
Injection with Diluent. 
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 
DYNASTAT  Injection  is  a  white  to  off-white,  preservative-free,  lyophilised  powder  in  a 
single-use  vial.    For  intravenous  (IV)  or  intramuscular  (IM)  administration,  DYNASTAT 
Injection  should  be  reconstituted  with  1 mL  (20 mg  vials)  or  2 mL  (40 mg  vials)  sodium 
chloride  solution  (0.9%  w/v),  or  a  suitable  alternative  (see  DOSAGE  AND 
ADMINISTRATION). 
Version: pfpdynav10213 
Supersedes: pfpdynav10912 

Page 2 of 25 
DILUENT FOR INJECTION 
DYNASTAT  Injection  may  be  supplied  with  a  2 mL  capacity  diluent  ampoule  with  a  fill 
volume of either 1 mL or 2 mL Sodium Chloride
Intravenous Infusion (0.9% w/v) BP. 
RECONSTITUTED SOLUTION 
The reconstituted solution is clear and colourless. 
DYNASTAT  Injection  20 mg  and  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), DYNAST