SUBOXONE FILM 12/3 buprenorphine (as hydrochloride) 12 mg naloxone (as hydrochloride dihydrate) 3 mg soluble film sachet

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

buprenorphine hydrochloride, Quantity: 12.96 mg (Equivalent: buprenorphine, Qty 12 mg); naloxone hydrochloride dihydrate, Quantity: 3.66 mg (Equivalent: naloxone, Qty 3 mg)

Disponible des:

Indivior Pty Ltd

Designació comuna internacional (DCI):

buprenorphine hydrochloride,naloxone hydrochloride dihydrate

formulario farmacéutico:

Soluble Film

Composición:

Excipient Ingredients: acesulfame potassium; citric acid; maltitol solution; hypromellose; polyethylene oxide; sodium citrate; sunset yellow FCF; Flavour; titanium dioxide; propylene glycol; purified water; industrial methylated spirit

Vía de administración:

Sublingual, Buccal

Unidades en paquete:

28 sachets

tipo de receta:

(S8) Controlled Drug

indicaciones terapéuticas:

Treatment of opiate dependence within a framework of medical, social, and pyschological treatment.

Resumen del producto:

Visual Identification: Orange film imprinted with white ink.; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

2014-05-20

Fitxa tècnica

1
AUSTRALIAN PRODUCT INFORMATION
SUBOXONE
® FILM (BUPRENORPHINE/NALOXONE)
1
NAME OF THE MEDICINE
SUBOXONE FILM contains buprenorphine (as hydrochloride) and naloxone
(as hydrochloride
dihydrate) at a ratio of 4:1 buprenorphine: naloxone (ratio of free
bases).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SUBOXONE FILM is available in four dosage strengths:
2 mg buprenorphine (as hydrochloride) + 0.5 mg naloxone (as
hydrochloride dihydrate)
4 mg buprenorphine (as hydrochloride) + 1 mg naloxone (as
hydrochloride dihydrate)
8 mg buprenorphine (as hydrochloride) + 2 mg naloxone (as
hydrochloride dihydrate) and
12 mg buprenorphine (as hydrochloride) + 3 mg naloxone (as
hydrochloride dihydrate).
Buprenorphine hydrochloride is a white powder, weakly acidic with
limited solubility in water
(19.5 mg /mL at 37

C, pH 4.1). Chemically, it is 21- Cyclopropyl-7

-

(S) -1- hydroxy-1, 2, 2 -
trimethylpropyl

-6,
14-endo-ethano-6,
7,
8,
14-tetrahydrooripavine
hydrochloride.
Buprenorphine hydrochloride has the molecular formula C
29
H
41
NO
4
HCl and the molecular
weight is 504.09. The CAS number is 53152-21-9.
Naloxone hydrochloride is a white to slightly off-white powder that
exists as the dihydrate and is
soluble in water, in dilute acids and in strong alkali. Chemically, it
is (-)-17-Allyl-4, 5

-epoxy-3,
14-dihydroxymorphinan-6-one
hydrochloride
dihydrate.
Naloxone
hydrochloride
has
the
molecular formula C
19
H
21
NO
4
HCl .2H
2
O and the molecular weight is 399.87.
For the full list of excipients, see section 6.1.
WARNINGS
_HAZARDOUS AND HARMFUL USE _
Although SUBOXONE FILM is indicated for the treatment of opioid
dependence it still poses risks of
hazardous and harmful use which can lead to overdose and death.
Monitor the patient’s ongoing risk of
hazardous and harmful use regularly during opioid substitution therapy
with SUBOXONE FILM (see section
4.4. Special Warnings and Precautions for Use).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life‐threatening or fatal respiratory depression may occur