KETESSE GRANULES FOR ORAL SOLUTION 25 mgsachet

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

DEXKETOPROFEN TROMETAMOL 36.90 mg eqv. to DEXKETOPROFEN

Dostupné z:

A. MENARINI SINGAPORE PTE. LTD.

ATC kód:

M01AE17

Forma lieku:

GRANULE, FOR SOLUTION

Zloženie:

DEXKETOPROFEN TROMETAMOL 36.90 mg eqv. to DEXKETOPROFEN 25.00 mg

Spôsob podávania:

ORAL

Typ predpisu:

Prescription Only

Výrobca:

LABORATORIOS MENARINI S.A.

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2015-10-29

Súhrn charakteristických

1
PACKAGE INSERT
KETESSE
® GRANULES FOR ORAL SOLUTION.
Dexketoprofen (as trometamol)
1.
NAME OF THE MEDICINAL PRODUCT
KETESSE 25 mg granules for oral solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of granules for oral solution contains 25 mg
dexketoprofen, as dexketoprofen trometamol.
Excipients with known effect:
Sucrose: 2.418 g
For the full list of
_ _
excipients, see section
_ _
6.1.
3.
PHARMACEUTICAL FORM
Granules for oral solution,
lemon yellow coloured granules.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Short term symptomatic treatment of acute pain of mild to moderate
intensity, such as acute musculo-
skeletal pain, dysmenorrhoea and dental pain.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Adults:
According to the nature and severity of pain, the recommended dosage
is generally 25 mg every 8
hours. The total daily dose should not exceed 75 mg.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4.).
KETESSE is only intended for short term use and the treatment must be
limited to the symptomatic
period.
Elderly:
In elderly patients it is recommended to start the therapy at the
lower end of the dosage range (50 mg
total daily dose). The dosage may be increased to that recommended for
the adult only after good
general tolerance has been ascertained. Due to the possible adverse
effect profile (see section 4.4),
elderly individuals should receive particularly close monitoring.
_ _
Hepatic impairment:
Patients with mild to moderate hepatic dysfunction should start
therapy at reduced doses (50 mg total
daily dose) and be closely monitored. KETESSE should not be used in
patients with severe hepatic
dysfunction.
Renal impairment:
The initial dosage should be reduced to 50 mg total daily dose in
patients with mildly impaired renal
function (creatinine clearance 60 – 89 ml / min) (see section 4.4).
KETESSE should not be used in
patients with moderate to severe renal dysfunction (crea