INVEGA paliperidone 12mg modified release tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

paliperidone, Quantity: 12 mg

Disponibil de la:

Janssen-Cilag Pty Ltd

INN (nume internaţional):

Paliperidone

Forma farmaceutică:

Tablet, modified release

Compoziție:

Excipient Ingredients: polyethylene oxide; sodium chloride; povidone; stearic acid; butylated hydroxytoluene; iron oxide yellow; iron oxide red; hyetellose; macrogol 3350; cellulose acetate; hypromellose; titanium dioxide; macrogol 400; Carnauba Wax; iron oxide black; purified water; isopropyl alcohol; propylene glycol

Calea de administrare:

Oral

Unități în pachet:

56 tablets, 7 tablets, 28 tablets

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

INVEGA is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention. INVEGA is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/or mood stabilizers (lithium and valproate).

Rezumat produs:

Visual Identification: Dark yellow, capsule shaped tablets imprinted with "PAL 12".; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2007-09-17

Caracteristicilor produsului

CCDS200407ver17
Page 1 of 29
INVEGA(200729)API
INVEGA

PALIPERIDONE
AUSTRALIAN PRODUCT INFORMATION
1.
NAME OF THE MEDICINE
Paliperidone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
INVEGA (paliperidone) is a novel antipsychotic agent belonging to the
benzisoxazole-derivatives class.
INVEGA is available as a modified release tablet containing 3, 6, 9
and 12 mg of paliperidone.
Excipient(s) with known effect:
Lactose monohydrate - 3 mg tablet only.
For a full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Modified Release Tablets.
3 mg
White, capsule shaped tablets imprinted with “PAL 3”.
6 mg
Beige, capsule shaped tablets imprinted with “PAL 6”.
9 mg
Pink, capsule shaped tablets imprinted with “PAL 9”.
12 mg
Dark yellow, capsule shaped tablets imprinted with “PAL 12”.
INVEGA utilises osmotic drug-release technology, whereby osmotic
pressure delivers paliperidone
from the dosage form at a controlled rate. The system, which resembles
a capsule-shaped tablet in
appearance,
comprises
an
osmotically
active
tri-layer
core
surrounded
by
a
sub-coat
and
semipermeable membrane. The tri-layer core is composed of two drug
layers containing the drug and
excipients, and a push layer containing osmotically active components.
There are two precision laser-
drilled orifices on the drug-layer dome of the tablet. Each strength
is identified by a unique colour
overcoat and print markings. In an aqueous environment, such as the
gastrointestinal tract, the water-
dispersible colour overcoat erodes quickly. Water is then imbibed
through the semipermeable, rate-
controlling membrane. The membrane controls the rate at which water
enters the tablet core, which,
in turn, controls drug delivery. The hydrophilic polymers of the core
hydrate and swell, creating a gel
containing paliperidone that is then pushed out through the tablet
orifices. The biologically inert
components of the tablet remain intact during gastrointestinal transit
and are eliminated in the stool as
a tablet shell, along wit