Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Buprenorphine hydrochloride 2.16mg equivalent to 2 mg buprenorphine; Naloxone hydrochloride dihydrate 0.61mg equivalent to 0.5 mg naloxone
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Buprenorphine hydrochloride 2.16 mg (equivalent to 2 mg buprenorphine)
2mg/0.5mg
Sublingual tablet
Active: Buprenorphine hydrochloride 2.16mg equivalent to 2 mg buprenorphine Naloxone hydrochloride dihydrate 0.61mg equivalent to 0.5 mg naloxone Excipient: Acesulfame potassium Citric acid Lactose monohydrate Lemon flavour PHS-020484 Magnesium stearate Maize starch Mannitol Povidone Sodium citrate dihydrate
Blister pack, PVC/PVdC-Al - 7 tablets, 7 tablets
Class C4 Controlled Drug
Class C4 Controlled Drug
Indivior UK Limited
Treatment of opiate dependence, within a framework of medical, social and psychological treatment. Naloxone is included in SUBOXONE to deter intravenous misuse of the product.
Package - Contents - Shelf Life: Blister pack, Paper/Aluminium/Nylon/Aluminium/PVC - 7 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Paper/Aluminium/Nylon/Aluminium/PVC - 28 tablets - 36 months from date of manufacture stored at or below 30°C
2000-04-04
Page 1 of 5 SUBOXONE ® SUBLINGUAL TABLETS _Buprenorphine Hydrochloride + Naloxone Hydrochloride Dihydrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about SUBOXONE. It does not contain all the available information. All medicines have risks and benefits. Your doctor has weighed the risks of you taking SUBOXONE against the benefits you may gain and he/she believes it will help in your treatment. IF YOU HAVE ANY CONCERNS ABOUT TAKING SUBOXONE, ASK YOUR DOCTOR. KEEP THIS LEAFLET. You may want to read it again. WHAT IS SUBOXONE USED FOR? SUBOXONE is used as part of a medical, social and psychological treatment program for patients dependent on opioids like heroin, morphine, oxycodone or codeine. SUBOXONE is used to help such patients to regain control over their lives. SUBOXONE tablets contain the active ingredients buprenorphine hydrochloride and naloxone hydrochloride dihydrate. Buprenorphine acts as a substitute for opioids like heroin and it helps withdrawal from opioid over a period of time. When taken sublingually (under the tongue) as prescribed, naloxone has no effect, as it is very poorly absorbed. However, if SUBOXONE is injected, naloxone will act to block the effects of other opioids like heroin, methadone or morphine, leading to bad withdrawal symptoms. Therefore, naloxone is included in SUBOXONE to discourage misuse by injection, as it can cause very bad withdrawal symptoms. SUBOXONE should be used exactly as prescribed by your doctor. Ask your doctor if you have any questions about why SUBOXONE has been prescribed for you. BEFORE YOU TAKE SUBOXONE SUBOXONE is not suitable for everyone. _WHEN YOU MUST NOT TAKE _ _SUBOXONE _ • If you are under the age of 16 years. • If you are allergic to buprenorphine or to naloxone or to any of the other ingredients in this medicine (see Product Description below). • If you have serious breathing problems. • If you have serious problems with your liver, or if your doctor detects the development of • su Belgenin tamamını okuyun
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME SUBOXONE 2 mg/0.5 mg sublingual tablet SUBOXONE 8 mg/2 mg sublingual tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sublingual tablet of SUBOXONE 2 mg/0.5 mg contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate). Each sublingual tablet of SUBOXONE 8 mg/2mg contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate). Excipients with known effect: The sublingual tablets contain lactose (as monohydrate): 42 mg in each SUBOXONE 2 mg/0.5 mg and 168 mg in each SUBOXONE 8 mg/2 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sublingual tablet SUBOXONE 2 mg/0.5 mg: white, hexagonal, biconvex tablets debossed with a “N2”. SUBOXONE 8 mg/2 mg: white, hexagonal, biconvex tablets debossed with a “N8”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of opioid dependence, within a framework of medical, social and psychological treatment. Naloxone is included in SUBOXONE to deter intravenous misuse of the product. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with SUBOXONE sublingual tablets is intended for adults and children aged 16 years or WARNINGS _HAZARDOUS AND HARMFUL USE _ Although SUBOXONE 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 (see section 4.4. Special Warnings and Precautions for Use). _LIFE THREATENING RESPIRATORY DEPRESSION _ Serious, life‐threatening or fatal respiratory depression may occur with the use of SUBOXONE. Be aware of situations which increase the risk of respiratory depression, and monitor patients closely, especially on initiation or following a dose increase (see section 4.4 Special Warnings and Precautions for Use). _CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, Belgenin tamamını okuyun