Parecoxib 40 mg powder and solvent for solution for injection

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Parecoxib

Disponible des:

Noridem Enterprises Limited

Codi ATC:

M01AH04

Designació comuna internacional (DCI):

Parecoxib

Dosis:

40 milligram(s)

formulario farmacéutico:

Powder and solvent for solution for injection

Área terapéutica:

parecoxib

Estat d'Autorització:

Not marketed

Data d'autorització:

2021-10-08

Informació per a l'usuari

PACKAGE LEAFLET:
INFORMATION FOR THE USER
PARECOXIB 40 MG POWDER AND
SOLVENT FOR SOLUTION FOR INJECTION
parecoxib
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU ARE GIVEN THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need
to read it again.
-
If you have any 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 Parecoxib is and what it is
used for
2.
What you need to know before
you are given Parecoxib
3.
How Parecoxib is given
4.
Possible side effects
5.
How to store Parecoxib
6.
Contents of the pack and other
information
1.
WHAT PARECOXIB IS AND WHAT IT
IS USED FOR
Parecoxib contains the active
substance parecoxib.
Parecoxib is used for the short-term
treatment of pain in adults after an
operation. It belongs to the group 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.
Parecoxib works by lowering the
amount of these prostaglandins.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN PARECOXIB
PARECOXIB MUST NOT BE GIVEN:
•
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 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

Fitxa tècnica

Health Products Regulatory Authority
26 October 2021
CRN009JLJ
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Parecoxib 40 mg powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Powder:
Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium).
After reconstitution with 2 ml solvent, the concentration of parecoxib
is 20 mg/mL.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: 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 parecoxib 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
of Parecoxib and reduce the maximum daily dose to
40 mg (see section 5.2).
_Hepatic impairment_
There is no clinical experience in patients with severe h