PREGABALIN-DRLA pregabalin 100 mg capsule blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

pregabalin, Quantity: 100 mg

Доступно од:

Dr Reddys Laboratories Australia Pty Ltd

INN (Међународно име):

Pregabalin

Фармацеутски облик:

Capsule, hard

Састав:

Excipient Ingredients: purified talc; lactose monohydrate; Gelatin; sodium lauryl sulfate; titanium dioxide; iron oxide red; maize starch; purified water

Пут администрације:

Oral

Јединице у пакету:

60, 14, 20, 56

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Pregabalin-DRLA (pregabalin) is indicated for the treatment of neuropathic pain in adults.,Pregabalin-DRLA (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Резиме производа:

Visual Identification: Size 3 hard gel capsule with opaque red coloured cap and red coloured body, imprinted "RDY" on cap and "294" on body with black imprinting ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус ауторизације:

Licence status A

Датум одобрења:

2016-12-21

Карактеристике производа

AUSTRALIAN PRODUCT INFORMATION – PREGABALIN-DRLA
(PREGABALIN) CAPSULES
1
NAME OF THE MEDICINE
Pregabalin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PREGABALIN-DRLA contains the active ingredient pregabalin. Pregabalin
is an analogue of the
neurotransmitter gamma-aminobutyric acid (GABA). It has analgesic and
anticonvulsant
activity. PREGABALIN-DRLA capsules contain 25 mg, 50 mg, 75 mg, 100
mg, 150 mg, 200 mg,
225 mg or 300 mg pregabalin.
Excipient(s) with known effect:
•
Sugars as lactose monohydrate
For the full list of excipients, see Section 6.1 – List of
excipients
3
PHARMACEUTICAL FORM
PREGABALIN-DRLA 25 mg capsules: an opaque white hard gelatin capsule
of size 4, imprinted
‘RDY’ on the cap and ‘291’ on the body with black ink.
PREGABALIN-DRLA 50 mg capsules: an opaque white hard gelatin capsule
of size 3, imprinted
‘RDY’ on the cap and ‘292’ on the body with black ink. The
capsule body is also marked
with a black band.
PREGABALIN-DRLA 75 mg capsules: a hard gelatin capsule of size 4, i m
pr i n te d ‘ RD Y ’ o n
t h e o pa q ue r e d co lo ur ed c a p a nd ‘2 9 3’ o n t he o pa
q ue w h i te c olo u re d b o dy
w i t h b lac k i nk .
PREGABALIN-DRLA 100 mg capsules: a hard gelatin capsule of size 3,
imprinted ‘RDY’ on the
opaque red coloured cap and ‘294’ on the opaque red coloured body
with black ink.
PREGABALIN-DRLA
150
mg
capsules:
an
opaque
white
hard
gelatin
capsule
of
size
2,
imprinted ‘RDY ’ on the cap and ‘295’ on the body with black
ink.
PREGABALIN-DRLA 200 mg capsules: a n o p a q u e light red coloured
hard gelatin capsule
of size 1,
i m p r i n t e d
‘ R D Y ’
o n
t h e c a p a n d
‘ 2 9 6 ’
o n
t h e b o d y w i t h
b l a c k i n k .
PREGABALIN-DRLA 225 mg capsules: a hard gelatin capsule of size 1,
imprinted ‘RDY’ on the
opaque light red coloured cap and ‘297’ on the opaque white
coloured body with black
ink.
PREGABALIN-DRLA 300 mg capsules: a hard gelatin capsule of size 0,
imprinted ‘RDY ’ on the
1
opaque red coloured cap and