Brufen

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Ibuprofen 200mg;  

Dostopno od:

Abbott Laboratories (NZ) Ltd

INN (mednarodno ime):

Ibuprofen 200 mg

Odmerek:

200 mg

Farmacevtska oblika:

Film coated tablet

Sestava:

Active: Ibuprofen 200mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Methylated spirits Microcrystalline cellulose Purified talc Purified water Sodium laurilsulfate Titanium dioxide

Enote v paketu:

Blister pack, PVC/Al or PVC/PVDC/Al, 500 tablets

Razred:

Prescription

Tip zastaranja:

Prescription

Izdeluje:

BASF Corporation

Povzetek izdelek:

Package - Contents - Shelf Life: Blister pack, PVC/Al or PVC/PVDC/Al - 500 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE sealed with PP caps, 500 tablets - 500 tablets - 36 months from date of manufacture stored at or below 25°C

Datum dovoljenje:

2005-09-20

Lastnosti izdelka

Page 1 of 15
NEW ZEALAND DATA SHEET
BRUFEN

_ _
1. PRODUCT NAME
Brufen

400 mg and 600 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400 mg film-coated tablet contains 400 mg of ibuprofen.
Each 600 mg film-coated tablet contains 600 mg of ibuprofen.
Excipients with known effect: contains sulfites and sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Brufen 400 mg and 600 mg tablets are white, pillow-shaped, film-coated
tablets.
Do not halve the tablets._ _
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
•
Rheumatoid arthritis
•
Osteoarthritis
•
Juvenile rheumatoid arthritis
•
Primary dysmenorrhoea
•
Pyrexia
Brufen is also indicated for the relief of acute and/or chronic pain
states in which there is an
inflammatory component.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
After assessing risk/benefit ratio in each individual patient, the
lowest effective dose for the shortest
duration should be used.
ADULTS
The recommended initial dosage of Brufen is 1200 mg - 1800 mg daily in
divided doses. Some
patients can be maintained on 600 - 1200 mg daily. In severe or acute
conditions it can be
advantageous to increase the dosage until the acute phase is brought
under control, providing that
the total daily dosage does not exceed 2400 mg in divided doses.
Page 2 of 15
_PRIMARY DYSMENORRHOEA _
The initial dose is 400-800 mg at the first sign of pain or menstrual
bleeding, then 400 mg 4-6 hourly
with a maximum total daily dose of 1,600 mg._ _
_MAINTENANCE DOSE _
In all indications the dose should be adjusted for each patient and
the smallest dose that results in
acceptable control of the symptoms employed. In general, patients with
rheumatoid arthritis and
osteoarthritis tend to require higher doses than patients with other
conditions.
SPECIAL POPULATIONS
_ELDERLY _
In elderly patients receiving 600 - 1,200 mg daily ibuprofen appeared
to be well tolerated. However,
since elderly patients may have a degree of impaired liver or renal
f