Keral 50mg/2ml Solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEXKETOPROFEN

Available from:

Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg

ATC code:

M01AE17

INN (International Name):

DEXKETOPROFEN 25 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

DEXKETOPROFEN 25 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2006-03-21

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 pharmacis. 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 packs 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 k

Summary of Product characteristics

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 (as
dexketoprofen trometamol). Each ml of
solution for injection/ infusion contains dexketoprofen 25 mg (as
dexketoprofen trometamol)
Excipients with known effects: Each ampoule of 2 ml contains 200 mg
ethanol (96 per cent).
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 dosage should be reduced to 50 mg total daily dose in patients
with mild to moderate (