Dynastat 40mg powder and solvent for solution for injection vials

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Parecoxib sodium

Boleh didapati daripada:

Pfizer Ltd

Kod ATC:

M01AH04

INN (Nama Antarabangsa):

Parecoxib sodium

Dos:

40mg

Borang farmaseutikal:

Powder and solvent for solution for injection

Laluan pentadbiran:

Intramuscular; Intravenous

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 15010402; GTIN: 5012882008871

Risalah maklumat

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
DYNASTAT 40 MG POWDER AND SOLVENT 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 TAKE 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 pr

Ciri produk

OBJECT 1
DYNASTAT 40MG POWDER FOR SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 23-Mar-2017 | Pfizer
Limited
1. Name of the medicinal product
Dynastat 40 mg powder for solution for injection
Dynastat 40 mg powder and solvent for solution for injection
2. Qualitative and quantitative composition
Each vial/powder 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).
Powder and solvent for solution for injection (powder for injection).
White to off-white powder.
Solvent: clear and colourless solution.
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.
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
a