Dynastat

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

parecoxib sodium

Available from:

Pfizer Europe MA EEIG

ATC code:

M01AH04

INN (International Name):

parecoxib

Therapeutic group:

Coxibs, Antiinflammatory and antirheumatic products

Therapeutic area:

Pain, Postoperative

Therapeutic indications:

For the short-term treatment of postoperative pain in adults.,

Product summary:

Revision: 32

Authorization status:

Authorised

Authorization date:

2002-03-22

Patient Information leaflet

52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE USER
DYNASTAT 40 MG POWDER FOR SOLUTION FOR INJECTION
parecoxib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dynastat is and what it is used for
2.
What you need to know before you use Dynastat
3.
How to use Dynastat
4.
Possible side effects
5.
How to store Dynastat
6.
Contents of the pack and other information
1.
WHAT DYNASTAT IS AND WHAT IT IS USED FOR
Dynastat contains the active substance parecoxib.
Dynastat is used for the short-term treatment of pain in adults after
an operation. It is one of a family
of medicines called COX-2 inhibitors (this is short for
_cyclo-oxygenase-2 inhibitors_
). Pain and
swelling are sometimes caused by substances in the body called
_prostaglandins_
. Dynastat works by
lowering the amount of these prostaglandins.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DYNASTAT
DO NOT USE DYNASTAT
-
if you are allergic to parecoxib or any of the other ingredients of
this medicine (listed in section 6)
-
if you have had a serious allergic reaction (especially a serious skin
reaction) to any medicines
-
if you have had an allergic reaction to a group of medicines called
“sulfonamides” (e.g. some
antibiotics used to treat infections)
-
if you currently have a gastric or intestinal ulcer or bleeding in the
stomach or gut
-
if you have had an allergic reaction to acetylsalicylic acid (aspirin)
or to other NSAIDs (e.g.
ibuprofen) or to COX-2 inhibitors. Reactions might include wheezing
(bronchospasm), badly
blocked nose, itchy skin, rash or swelling of the face, lips or
tongue, other allergic reactions or
nasal polyps after taking these medicines
-
if you are more than 6 months p

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dynastat 40 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium).
After reconstitution, the
concentration of parecoxib is 20 mg/ml. Each 2 ml of reconstituted
powder contains 40 mg of
parecoxib.
Excipient with known effect
This medicinal product contains less than 1 mmol sodium (23 mg) per
dose.
When reconstituted in sodium chloride 9 mg/ml (0.9%) solution,
Dynastat contains approximately
0.44 mmol of sodium per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection (powder for injection).
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the short-term treatment of postoperative pain in adults.
The decision to prescribe a selective cyclooxygenase-2 (COX-2)
inhibitor should be based on an
assessment of the individual patient's overall risks (see sections 4.3
and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 40 mg administered intravenously (IV) or
intramuscularly (IM), followed
every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80
mg/day.
As the cardiovascular risk of COX-2 specific inhibitors may increase
with dose and duration of
exposure, the shortest duration possible and the lowest effective
daily dose should be used. There is
limited clinical experience with Dynastat treatment beyond three days
(see section 5.1).
Concomitant use with opioid analgesics
_ _
Opioid analgesics can be used concurrently with parecoxib, dosing as
described in the paragraph
above. In all clinical assessments parecoxib was administered at a
fixed time interval whereas the
opioids were administered on as needed basis.
Elderly
No dose adjustment is generally necessary in elderly patients (≥65
years). However, for elderly
patients weighing less than 50 kg, treatment should be initiated with
half the usual recommended dose