Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
buprenorphine hydrochloride, Quantity: 12.96 mg (Equivalent: buprenorphine, Qty 12 mg); naloxone hydrochloride dihydrate, Quantity: 3.66 mg (Equivalent: naloxone, Qty 3 mg)
Indivior Pty Ltd
buprenorphine hydrochloride,naloxone hydrochloride dihydrate
Soluble Film
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
Sublingual, Buccal
28 sachets
(S8) Controlled Drug
Treatment of opiate dependence within a framework of medical, social, and pyschological treatment.
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
Licence status A
2014-05-20
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 Přečtěte si celý dokument