KETESSE® 50 mg2 ml Solution for InjectionInfusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

DEXKETOPROFEN TROMETAMOL; DEXKETOPROFEN TROMETAMOL

Available from:

A. MENARINI SINGAPORE PTE. LTD.

INN (International Name):

DEXKETOPROFEN TROMETAMOL; DEXKETOPROFEN TROMETAMOL

Units in package:

20ampoule Ampoules; 10ampoule Ampoules; 6ampoule Ampoules; 5ampoule Ampoules; 1ampoule Ampoules; 100ampoule Ampoules

Manufactured by:

A. MENARINI MANUFACTURING LOGISTICS & SERVICES S.R.L.

Summary of Product characteristics

PACKAGE INSERT
KETESSE
® 50 MG/2 ML
SOLUTION FOR INJECTION/ INFUSION
Dexketoprofen (as trometamol)
1.
NAME OF THE MEDICINAL PRODUCT
Ketesse 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).
For the full list of excipients, see section 6.1.
3.
PRODUCT DESCRIPTION
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
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4).
_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.
Ketesse 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, Ketesse 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 s