Country: Singapúr
Tungumál: enska
Heimild: HSA (Health Sciences Authority)
Naproxen
ORION PHARMA (SG) PTE. LTD.
M01AE02
SUSPENSION
Naproxen 25.00 mg/ml
ORAL
Prescription Only
Orion Corporation, Orion Pharma
ACTIVE
2022-03-23
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 Lestu allt skjalið