Aspen Dexamfetamine

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Aktív összetevők:

Dexamfetamine sulfate 5mg

Beszerezhető a:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Adagolás:

5 mg

Gyógyszerészeti forma:

Tablet

Összetétel:

Active: Dexamfetamine sulfate 5mg Excipient: Lactose Magnesium stearate Povidone Wheat starch

Recept típusa:

Class B1 Controlled Drug

Terápiás javallatok:

The treatment of well-established and proven narcolepsy.

Termék összefoglaló:

Package - Contents - Shelf Life: Bag, plastic, HDPE bottle with CR PP cap and desiccant - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Engedély dátuma:

2022-07-15

Termékjellemzők

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 9
1.
PRODUCT NAME (strength pharmaceutical form)
Aspen Dexamfetamine, Tablet, 5mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substance: Dexamfetamine sulfate 5 mg
Excipient(s) with known effect: For the full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL FORM
Oral tablet.
Presentation: White, round flat tablet with bevelled edges with
“D5” imprinted and scored on
one side and plain on the other.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
For the treatment of well-established and proven narcolepsy. It is
also indicated for children
with refractory hyperkinetic states under the supervision of a
physician specialising in child
psychiatry.
4.2
Dose and method of administration
Dexamfetamine should be started at the lowest possible dose and should
then be individually
and slowly adjusted to the lowest effective dose for each individual.
Time of administration should receive special attention because of
insomnia.
_For narcolepsy: _
Adults:
Oral, 5 to 20 mg a day in divided doses as needed and tolerated. The
usual starting dose is
5 mg a day, given in divided doses. Doses may be increased if
necessary by 5 mg a day at
weekly intervals to a suggested maximum of 20 mg a day.
Elderly:
Start with 5 mg a day, and increase by increments of 5 mg at weekly
intervals to a suggested
maximum of 20 mg a day.
Children:
_Children up to 6 years of age _
_ _
_ _
Dosage has not been established.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 9
_Children 6 to 12 years of age _
Oral, 5 mg a day, the dosage being increased by 5 mg a day at one-week
intervals until the desired response is obtained or until the adult
dose is
reached.
_ _
_For attention-deficit hyperactivity disorders: _
Children:
_ _
_Children up to 3 years of age _
_ _
Use is not recommended.
_ _
_Children 3 to 5 years of age _
Oral, 2.5 mg once a day, the dosage being increased by 2.5 mg a day at
one-
week intervals until the desired response is obtained.