PRONAXEN ORAL SUSPENSION 25 MGML

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

Naproxen

Tilgjengelig fra:

ORION PHARMA (SG) PTE. LTD.

ATC-kode:

M01AE02

Legemiddelform:

SUSPENSION

Sammensetning:

Naproxen 25.00 mg/ml

Administreringsrute:

ORAL

Resept typen:

Prescription Only

Produsert av:

Orion Corporation, Orion Pharma

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2022-03-23

Preparatomtale

PRONAXEN ORAL SUSPENSION 25 MG/ML
1.
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Propionic acid derivatives, ATC code: M01AE02.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One millilitre contains 25 mg of naproxen.
Excipients with known effect:
Sorbitol (E420) 400 mg/ml
Methyl parahydroxybenzoate (E218) 1 mg/ml
Propyl parahydroxybenzoate (E216) 0.2 mg/ml
Sodium 0.8 mg/ml
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Oral suspension
White to off-white homogeneous suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
•
Rheumatoid arthritis, spondyloarthropathies (including ankylosing
spondylitis)
•
Osteoarthrosis
•
Acute gout
•
Acute musculoskeletal disorders with pain
•
Dysmenorrhoea
Children
•
Juvenile rheumatoid arthritis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adverse drug reactions may be reduced by using the lowest effective
dose for the shortest duration
possible to manage the symptoms (see section 4.4).
_Adults _
Usually, 250–500 mg (10–20 ml) twice a day based on the individual
need.
If the predominant symptom in rheumatoid arthritis is morning
stiffness, a single dose of 500–750 mg
(20–30 ml) in the evenings may be adequate.
In the treatment of acute gout, the recommended dose is 750 mg at once
then 250 mg every 8 hours
until the attack has passed.
In the treatment of acute musculoskeletal disorders and dysmenorrhoea
the recommended dose is
500 mg initially followed by 250 mg at 6–8 hour intervals as needed,
with a maximum daily dose after
the first day of 1 250 mg.
_Paediatric population (over 5 years): _
For juvenile rheumatoid arthritis: in children aged over 5 years, the
recommended daily dose is
10 mg/kg divided into two doses. Dosing as per the table below.
Patients weighing over 50 kg may be
administered the adult dosage.
weight
daily dose
20–24 kg
4 ml x 2
25–29 kg
5 ml x 2
30–34 kg
6 ml x 2
35–40 kg
7 ml x 2
40–44 kg
8 ml x 2
45–49 kg
9 ml x 2
_Elderly patients _
In those over 70, the concentration of free