البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
BUPRENORPHINE AS HYDROCHLORIDE; NALOXONE AS HYDROCHLORIDE DIHYDRATE
NAOMI SHACO-EZRA LTD
N02AE01
SUBLINGUAL FILM
BUPRENORPHINE AS HYDROCHLORIDE 4 MG; NALOXONE AS HYDROCHLORIDE DIHYDRATE 1 MG
BUCCAL, SUBLINGUAL
Not required
AQUESTIVE THERAPEUTICS, USA
BUPRENORPHINE
Suboxone sublingual film is indicated for treatment of opioid dependence in adults and adolescents over 15 years of age. Suboxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.
2020-04-07
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only SUBOXONE film 2 mg/0.5 mg, for sublingual or buccal use SUBOXONE film 4 mg/1 mg, for sublingual or buccal use SUBOXONE film 8 mg/2 mg, for sublingual or buccal use SUBOXONE film 12 mg/3 mg, for sublingual or buccal use Active ingredients and their quantities in unit dose: SUBOXONE film 2 mg/0.5 mg, each film contains: Buprenorphine (as hydrochloride) 2 mg Naloxone (as hydrochloride dihydrate) 0.5 mg SUBOXONE film 4 mg/1 mg, each film contains: Buprenorphine (as hydrochloride) 4 mg Naloxone (as hydrochloride dihydrate) 1 mg SUBOXONE film 8 mg/2 mg, each film contains: Buprenorphine (as hydrochloride) 8 mg Naloxone (as hydrochloride dihydrate) 2 mg SUBOXONE film 12 mg/3 mg, each film contains: Buprenorphine (as hydrochloride) 12 mg Naloxone (as hydrochloride dihydrate) 3 mg Inactive ingredients - see section 6 “Further information” and section 2 “Important information about some of the ingredients of the medicine”. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. Important: SUBOXONE film should be kept in a safe place away from the reach of children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes SUBOXONE film, contact your doctor or emergency room immediately. 1. What is the medicine intended for ? SUBOXONE film is indicated for treatment of opioid dependence in adults and adolescents over 15 years of age. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. Therapeutic group: Buprenorphine- partial opioid agonist Naloxone- اقرأ الوثيقة كاملة
1 1 NAME OF THE MEDICINAL PRODUCT SUBOXONE FILM 2MG/0.5MG SUBOXONE FILM 4MG/1MG SUBOXONE FILM 8MG/2MG SUBOXONE FILM 12MG/3MG 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each SUBOXONE (2 mg buprenorphine/0.5 mg naloxone) FILM contains 2 mg buprenorphine (as 2.16 mg buprenorphine HCI) and 0.5 mg naloxone (as 0.61 mg naloxone HCI dihydrate) Excipients with known effect Each film contains 5.87 mg maltitol liquid and 0.01 mg FD&C yellow #6. Each SUBOXONE (4 mg buprenorphine/1 mg naloxone) FILM contains 4 mg buprenorphine (as 4.32 mg buprenorphine HCI) and 1 mg naloxone (as 1.22 mg naloxone HCI dihydrate) Excipients with known effect Each film contains 11.74 mg maltitol liquid and 0.02 mg FD&C yellow #6. Each SUBOXONE (8 mg buprenorphine/2 mg naloxone) FILM contains 8 mg buprenorphine (as 8.64 mg buprenorphine HCI) and 2 mg naloxone (as 2.44 mg naloxone HCI dihydrate) Excipients with known effect Each film contains 6.02 mg maltitol liquid and 0.02 mg FD&C yellow #6. Each SUBOXONE (12 mg buprenorphine/3 mg naloxone) FILM contains 12 mg buprenorphine (as 12.96 mg buprenorphine HCI) and 3 mg naloxone (as 3.66 mg naloxone HCI dihydrate) Excipients with known effect Each film contains 9.03 mg maltitol liquid and 0.02 mg FD&C yellow #6. For the full list of excipients, see section 13. 3 PHARMACEUTICAL FORM Film, for sublingual or buccal use 4 THERAPEUTIC INDICATIONS SUBOXONE sublingual film is indicated for treatment of opioid dependence in adults and adolescents over 15 years of age. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. 5 DOSAGE AND ADMINISTRATION 5.1 Important Dosage and Administration Information SUBOXONE film is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. 2 5.2 Induction Prior to induction, consideration should be given to the t اقرأ الوثيقة كاملة