Keral 50 mg/2ml solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dexketoprofen trometamol

Available from:

Menarini International Operations Luxembourg S.A.

ATC code:

M01AE; M01AE17

INN (International Name):

Dexketoprofen trometamol

Dosage:

50 mg/2ml

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:

2004-03-19

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KERAL 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 Keral is and what it is used for
2.
What you need to know before you use Keral
3.
How to use Keral
4.
Possible side effects
5.
How to store Keral
6.
Contents of the pack and other information
1.
WHAT KERAL IS AND WHAT IT IS USED FOR
Keral 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 KERAL
DO NOT USE KERAL:
•
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 sunlight) while taking ketopro

Summary of Product characteristics

Health Products Regulatory Authority
05 April 2023
CRN00D69L
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Keral 50 mg/2ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 2 ml contains: dexketoprofen 50 mg (asdexketoprofen
trometamol). Each ml of solution for injection/infusion
contains dexketoprofen 25 mg (asdexketoprofen 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.
Keral 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, Keral 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_
No dosage adjustment is generally necessary in older patients. However
because of the physiological decline in renal function
in elderly patients a lower dose is recommended in case of mild renal
function impairment: 50 mg total daily dose (see section
4.4).
_Hepatic impairment_
The do