PREGABALIN-TEVA pregabalin 225mg hard gelatin capsule blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

pregabalin, Quantity: 225 mg

Dostupno od:

Teva Pharma Australia Pty Ltd

INN (International ime):

Pregabalin

Farmaceutski oblik:

Capsule, hard

Sastav:

Excipient Ingredients: mannitol; pregelatinised maize starch; purified talc; titanium dioxide; Gelatin; iron oxide red; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administracija rute:

Oral

Jedinice u paketu:

21 capsules, 56 capsules, 60 capsules, 14 capsules

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Pregabalin is indicated for the treatment of neuropathic pain in adults

Proizvod sažetak:

Visual Identification: PREGABALIN-TEVA 225 mg capsules are opaque capsules with flesh cap and ivory body imprinted with '225' on capsule body in black ink; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2015-09-23

Svojstava lijeka

Teva Pharma Australia Pty Ltd
Version 4.0
1
AUSTRALIAN PRODUCT INFORMATION – PREGABALIN-TEVA (PREGABALIN)
CAPSULE
1
NAME OF THE MEDICINE
Pregabalin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin-Teva capsules contain 25 mg, 50 mg, 75 mg, 100 mg, 150 mg,
200 mg, 225 mg or 300 mg of
pregabalin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pregabalin-Teva 25 mg capsules: ivory opaque capsules imprinted with
“25” on capsule body in black ink.
Pregabalin-Teva 50 mg capsules: ivory opaque capsules imprinted with
radial black band on capsule cap and
“50” and radial black band on capsule body in black ink. The body
is also marked with a black band.
Pregabalin-Teva 75 mg capsules: opaque capsules with pink cap and
ivory body imprinted with “75” in black ink.
Pregabalin-Teva 100 mg capsules: pink opaque capsules imprinted with
“100” on capsule body in black ink.
Pregabalin-Teva 150 mg capsules: ivory opaque capsules imprinted with
“150” on capsule body in black ink.
Pregabalin-Teva 200 mg capsules: flesh opaque capsules imprinted with
“200” on capsule body in black ink.
Pregabalin-Teva 225 mg capsules: flesh opaque capsules with flesh cap
and ivory body imprinted with “225” on
capsules body in black ink.
Pregabalin-Teva 300 mg capsules: opaque capsules with pink cap and
ivory body imprinted with “300” on
capsule body in black ink.
All strengths or pack sizes may not be available in Australia.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Pregabalin is indicated for the treatment of neuropathic pain in
adults.
Pregabalin is indicated as adjunctive therapy in adults with partial
seizures with or without secondary
generalisation.
Teva Pharma Australia Pty Ltd
Version 4.0
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dose range is 150 to 600 mg per day given in two divided doses.
Pregabalin may be taken with or without
food.
NEUROPATHIC PAIN
Pregabalin treatment can be started at a dose of 150 mg per day, given
as two divided doses. Bas