Voltaren Rapid 25

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Diclofenac potassium 25mg;  ;  ;  ;  

Tersedia dari:

Haleon New Zealand ULC

INN (Nama Internasional):

Diclofenac potassium 25 mg

Dosis:

25 mg

Bentuk farmasi:

Tablet

Komposisi:

Active: Diclofenac potassium 25mg         Excipient: Calcium phosphate Colloidal silicon dioxide Dispersed Red (Ferric oxide 3% + Titanium dioxide 97%) Macrogol 8000 Magnesium stearate Maize starch Microcrystalline cellulose Opacode brown S-1-9210HV Povidone   Purified talc Sodium starch glycolate Sucrose

Unit dalam paket:

Blister pack, PVC/PE/PVDC/Al, 10 tablets

Kelas:

Restricted

Jenis Resep:

Restricted

Diproduksi oleh:

Novartis Grimsby Limited

Indikasi Terapi:

Short-term treatment in the following acute conditions: - post-traumatic pain, inflammation and swelling, e.g. due to sprains; - post-operative pain, inflammation and swelling, e.g. following dental or orthopaedic surgery; - painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis; - migraine attacks; - painful syndromes of the vertebral column; - non-articular rheumatism; - as an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/Al - 10 tablets - 30 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/PVDC/Al - 20 tablets - 30 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/PVDC/Al - 30 tablets - 30 months from date of manufacture stored at or below 30°C

Tanggal Otorisasi:

2001-08-17

Karakteristik produk

NEW ZEALAND DATA SHEET
VOLTAREN RAPID – Data Sheet
Page 1 of 16
1.
PRODUCT NAME
VOLTAREN RAPID 25
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient_:
Diclofenac potassium 25 mg per tablet
_Excipients_:
For full list of excipients, see section 6.1.
Each Voltaren Rapid 25 tablet contains 2.9 mg of potassium.
3.
PHARMACEUTICAL FORM
Voltaren
Rapid
25
tablets
are
pale
red,
round,
biconvex
and
sugar-coated.
The
diameter
is
approximately 7.7 mm with a thickness of about 5.0 mm.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Short-term treatment in the following acute conditions:
•
post-traumatic pain, inflammation and swelling, e.g. due to sprains
•
post-operative
pain,
inflammation
and
swelling,
e.g.
following
dental
or
orthopaedic
surgery
•
painful and/or inflammatory conditions in gynaecology, e.g. primary
dysmenorrhoea or
adnexitis
•
migraine attacks
•
painful syndromes of the vertebral column
•
non-articular rheumatism
•
as an adjuvant in severe painful inflammatory infections of the ear,
nose, or throat,
e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic
principles, the underlying
disease
should
be
treated
with
basic
therapy,
as
appropriate.
Fever
alone
is
not
an
indication.
4.2
Dose and method of administration
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for
the shortest possible duration should be used, which may minimise
adverse effects.
Voltaren Rapid 25 should be swallowed whole with liquid, preferably
before meals.
NEW ZEALAND DATA SHEET
VOLTAREN RAPID – Data Sheet
Page 2 of 16
Adults
Acute pain states with an inflammatory component
Following an initial loading dose of 50 mg, 25-50 mg is to be taken
every 8 hours if necessary.
The maximum daily dose is 150 mg.
Migraine
Following an initial loading dose of 50 mg, a further dose of 25-50 mg
may be taken after 2
hours if necessary. Further doses of 25-50 mg may be taken at
intervals of 4-6 hours, if
needed. The maximum daily dose is 150 mg.
Children
Children