Dynastat

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Parecoxib sodium 42.36mg Equivalent to 40 mg parecoxib;  

Dostupné z:

Pfizer New Zealand Limited

INN (Medzinárodný Name):

Parecoxib sodium 42.36 mg (Equivalent to 40 mg parecoxib)

Dávkovanie:

40 mg

Forma lieku:

Powder for injection

Zloženie:

Active: Parecoxib sodium 42.36mg Equivalent to 40 mg parecoxib   Excipient: Dibasic sodium phosphate heptahydrate Nitrogen Phosphoric acid Sodium hydroxide Hydrochloric acid Nitrogen Sodium chloride Sodium hydroxide Water for injection

Počet v balení:

Ampoule, glass, Diluent, 2 mL

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

Pfizer Pharmaceuticals LLC

Terapeutické indikácie:

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

Prehľad produktov:

Package - Contents - Shelf Life: Ampoule, glass, Diluent - 2 mL - 60 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 10 vial only pack - 10 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 - Vial, glass, Powder - 40 mg -  

Dátum Autorizácia:

2001-03-12

Príbalový leták

DYNASTAT
®
1
DYNASTAT
®
(DIE-NA-STAT)
_Parecoxib _powder for injection
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 o

Súhrn charakteristických

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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
DYNASTAT
®
40 mg Powder for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of DYNASTAT 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),
DYNASTAT
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.
DYNASTAT is a white to off-white, preservative-free, lyophilised
powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For a single peri-operative dose for the management of post-operative
pain.
The decision to prescribe DYNASTAT 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.
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4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
The
usual
recommended
dose
is
a
single
40 mg
dose
administered
intravenously
or
intramuscularly.
For
use
in
pregnancy,
refer
to
section
4.3
Contraindications
and
section
4.6
Fertility,
pregnancy and lactation.
ELDERLY
No dosage adjustment is generally necessary. However, for elderly
female patients weighing
less than 50 kg, the recommended dose of DYNASTAT is 20 mg (see
section 4.4 Special
warnings and precautions for use, Use in the Elderly and section 5.2
Pharmacokinetic
properties, Special populations, Elderly (>65 years)).
HEPATIC IMPAIRMENT
No dosage adjustment is generally necessary in patient