GABALEX MLABS gabapentin 400 mg capsule blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

gabapentin, Quantity: 400 mg

Disponible des:

Micro Labs Pty Ltd

Designació comuna internacional (DCI):

Gabapentin

formulario farmacéutico:

Capsule, hard

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

PVC/ PVDC-Aluminium blister pack of 100 capsules (10x10C in carton)

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Gabapentin is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,Gabapentin is indicated for the treatment of neuropathic pain.

Resumen del producto:

Visual Identification: Orange-Orange colour size'0' hard gelatin capsule contains free flowing white crystalline powder.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estat d'Autorització:

Licence status A

Data d'autorització:

2017-04-28

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION – GABALEX MLABS
(GABAPENTIN)
1. NAME OF THE MEDICINE
Gabapentin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Gabalex MLabs 100 mg capsules contains 100 mg, of gabapentin.
Gabalex MLabs 300 mg capsules contains 300 mg, of gabapentin
Gabalex MLabs 400 mg capsules contains 400 mg, of gabapentin
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
GABAPENTIN CAPSULES, 100MG:
Size ‘3’ hard gelatin capsule with white body and white cap,
containing 100 mg of gabapentin.
GABAPENTIN CAPSULES, 300MG:
Size ‘1’ hard gelatin capsule with yellow body and yellow
cap, containing 300 mg of gabapentin.
GABAPENTIN CAPSULES, 400MG:
Size ‘0’ hard gelatin capsule with orange body and orange
cap, containing 400 mg of gabapentin.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gabapentin is indicated for the treatment of partial seizures,
including secondarily generalised
tonic-clonic seizures, initially as add-on therapy in adults and
children age 3 years and above
who have not achieved adequate control with standard anti-epileptic
drugs.
Gabapentin is indicated for the treatment of neuropathic pain.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_EPILEPSY DOSAGE FOR ADULTS AND CHILDREN OLDER THAN 12 YEARS OF AGE _
Initiation of treatment should be as add-on therapy. Gabalex MLabs can
be given orally with
or without food.
In controlled clinical trials, the effective dose range was 900 mg/day
to 1800 mg/day given in
divided doses (three times a day).
Therapy may be initiated by administering 300 mg of Gabalex MLabs
three times a day on
Day 1, as 300 mg capsules, or by titrating the dose as described
below.
Titration to an effective dose can take place rapidly, over a few
days, giving 300 mg Gabalex
MLabs on Day 1, 300 mg Gabalex MLabs twice a day on Day 2, 300 mg
Gabalex MLabs
three times a day on Day 3, as 300 mg capsules. Titration may be
preferable for patients with
renal impairment, patients with encephalopathy, patients on more than
2 other antiepi