Ibuprofen

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Ibuprofen 200mg

Dostupno od:

Nova Pharmaceuticals NZ Limited

INN (International ime):

Ibuprofen 200 mg

Doziranje:

200 mg

Farmaceutski oblik:

Coated tablet

Sastav:

Active: Ibuprofen 200mg Excipient: Carnauba wax Colloidal silicon dioxide Hypromellose Lactose Magnesium stearate Maize starch Potato starch Purified talc Sodium starch glycolate Sucrose Titanium dioxide

Jedinice u paketu:

Blister pack, Al/PVC blister pack, 24 tablets

Razred:

General sale

Tip recepta:

General sale

Proizveden od:

Hubei Biocause Pharmaceutical Co Ltd

Proizvod sažetak:

Package - Contents - Shelf Life: Blister pack, Al/PVC blister pack - 24 tablets - 36 months from date of manufacture stored at or below 25°C

Datum autorizacije:

2008-03-17

Svojstava lijeka

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
IBUPROFEN, coated tablets 200 mg, Teva
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 200 mg of ibuprofen.
Excipient with known effect: Lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, capsule shaped coated tablets with no markings.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IBUPROFEN is indicated for analgesic and anti-inflammatory effect in
the treatment of rheumatoid
arthritis (including juvenile rheumatoid arthritis or Still's
disease), ankylosing spondylitis,
osteoarthritis and other non-rheumatoid (seronegative) arthropathies.
In the treatment of non-articular rheumatic conditions, IBUPROFEN is
indicated in periarticular
conditions such as frozen shoulder (capsulitis), bursitis, tendonitis,
tenosynovitis and low-back pain.
IBUPROFEN can also be used in soft-tissue injuries such as sprains and
strains.
IBUPROFEN is also indicated for its analgesic effect in the relief of
mild to moderate pain such as
dysmenorrhoea, dental and post-operative pain.
4.2
DOSE AND METHOD OF ADMINISTRATION
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the
shortest duration should be used.
_Adults:_
The recommended initial daily dose of IBUPROFEN is 1200-1800mg per day
in divided doses. Some
patients can be maintained on 600 -1200mg per day. In severe of acute
conditions it can be
advantageous to increase the dosage until the acute phase is brought
under control, providing that the
total daily dose does not exceed 2400mg in divided doses.
SPECIAL POPULATIONS:
_Children:_
The daily dosage of IBUPROFEN is 20mg per kg of body weight in divided
doses. In juvenile
rheumatoid arthritis up to 40mg per kg of bodyweight in divided doses
may be given. In children
weighing less than 30kg the total dose should not exceed 500mg in a 24
hour period.
_Elderly: _
Elderly patients are more prone to adverse effects. Caution must be
taken with dosage in this group.
_Renal impa