Enantyum 50 mg/2ml Solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dexketoprofen

Available from:

Laboratorios Menarini S.A.

ATC code:

M01AE; M01AE17

INN (International Name):

Dexketoprofen

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Propionic acid derivatives; dexketoprofen

Authorization status:

Not marketed

Authorization date:

2004-03-19

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENANTYUM 50 MG/2 ML
SOLUTION FOR INJECTION/ INFUSION
Dexketoprofen
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 any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Enantyum is and what it is used for
2.
What you need to know before you use Enantyum
3.
How to use Enantyum
4.
Possible side effects
5.
How to store Enantyum
6.
Contents of the pack and other information
1.
WHAT ENANTYUM IS AND WHAT IT IS USED FOR
Enantyum is a pain killer from the group of medicines called
non-steroidal anti-inflammatory drugs
(NSAIDs).
It is used to treat acute moderate to severe pain, when taking tablets
is not appropriate, such as post-
operative pain, renal colic (severe kidney pain) and low back pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ENANTYUM
DO NOT USE ENANTYUM:

If you are allergic to dexketoprofen or any of the other ingredients
of this medicine (listed in section 6);

If you are allergic to acetylsalicylic acid or to other non-steroidal
anti-inflammatory medicines;

If you have asthma or have suffered attacks of asthma, acute allergic
rhinitis (a short period of inflamed
lining of the nose), nasal polyps (lumps within the nose due to
allergy), urticaria (skin rash), angioedema
(swollen face, eyes, lips, or tongue, or respiratory distress) or
wheezing in the chest, after taking
acetylsalicylic acid or other non-steroidal anti-inflammatory
medicines;

If you have suffered from photoallergic or phototoxic reactions (a
particular form of reddening and/or
blistering of the skin exposed to su

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Enantyum 50 mg/2ml Solution for injection/infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 2 ml contains: dexketoprofen 50 mg (as dexketoprofen
trometamol). Each ml of solution for injection
contains dexketoprofen 25 mg (as dexketoprofen trometamol).
Excipients with known effects:
Each ampoule of 2 ml contains 200 mg ethanol (96 per cent) and 8.0 mg
sodium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear and colourless solution.
pH (7.0-8.0)
Osmolarity (270-328 mOsmol/l)
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of acute pain of moderate to severe intensity,
when oral administration is not appropriate such
as post-operative pain, renal colic and low back pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended dose is 50 mg every 8 – 12 hours. If necessary, the
administration can be repeated 6 hours apart. The
total daily dose should not exceed 150 mg.
Enantyum solution for injection/infusion is intended for short term
use and the treatment must be limited to the acute
symptomatic period (no more than two days). Patients should be
switched to an oral analgesic treatment when possible.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
In case of moderate to severe postoperative pain, Enantyum solution
for injection/infusion can be used in combination
with opioid analgesics, if indicated, at the same recommended doses in
adults (see section 5.1).
_Elderly_
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___