Morsadex 50 mg/2 ml solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dexketoprofen trometamol

Available from:

AS Kalceks

ATC code:

M01AE; M01AE17

INN (International Name):

Dexketoprofen trometamol

Dosage:

50/2 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

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

Therapeutic area:

Propionic acid derivatives; dexketoprofen

Authorization status:

Marketed

Authorization date:

2017-12-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MORSADEX 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 Morsadex is and what it is used for
2.
What you need to know before you use Morsadex
3.
How to use Morsadex
4.
Possible side effects
5.
How to store Morsadex
6.
Contents of the pack and other information
1.
WHAT MORSADEX IS AND WHAT IT IS USED FOR
Morsadex is a pain killer from the group of medicines called
non-steroidal anti-inflammatory drugs
(NSAIDs).
Morsadex 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 MORSADEX
DO NOT USE MORSADEX AND TELL THE DOCTOR:
-
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 NSAIDs;
-
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 aspirin or other NSAIDs;
-
if you have suffered from photoallergic or phototoxic reactions (a
particular form of reddening
and/or blistering of the skin exposed to sunlight) while taking
ketoprofen (NSAIDs) or fibrates
(medicines used to lo

Summary of Product characteristics

Health Products Regulatory Authority
14 November 2022
CRN00D6M6
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Morsadex 50 mg/2 ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains dexketoprofen trometamol corresponding to 25
mg of dexketoprofen.
One ampoule (2 ml) contains dexketoprofen trometamol corresponding to
50 mg of dexketoprofen.
Excipients with known effect
Each ampoule contains 200 mg ethanol (96 %) and 8.0 mg sodium
chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear colourless solution, free from visible particles.
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.
Morsadex 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, Morsadex can be used
in combination with opioid analgesics, if indicated, at
the same recommended doses in adults (see section 5.1).
_Paediatric population_
Morsadex has not been studied in children and adolescents. Therefore
the safety and efficacy of Morsadex in children and
adolescents have not been established and the medicine should not be
used in children and adolescents.
_Elderly_
No dosage adjustment is generally necessary in older patients. However
because of