Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
buprenorphine
Camurus AB
N07BC01
buprenorphine
Other nervous system drugs
Opioid-Related Disorders
Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.
Revision: 8
Authorised
2018-11-20
60 B. PACKAGE LEAFLET 61 PACKAGE LEAFLET: INFORMATION FOR THE USER BUVIDAL 8 MG PROLONGED-RELEASE SOLUTION FOR INJECTION BUVIDAL 16 MG PROLONGED-RELEASE SOLUTION FOR INJECTION BUVIDAL 24 MG PROLONGED-RELEASE SOLUTION FOR INJECTION BUVIDAL 32 MG PROLONGED-RELEASE SOLUTION FOR INJECTION BUVIDAL 64 MG PROLONGED-RELEASE SOLUTION FOR INJECTION BUVIDAL 96 MG PROLONGED-RELEASE SOLUTION FOR INJECTION BUVIDAL 128 MG PROLONGED-RELEASE SOLUTION FOR INJECTION BUVIDAL 160 MG PROLONGED-RELEASE SOLUTION FOR INJECTION buprenorphine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Buvidal is and what it is used for 2. What you need to know before you receive Buvidal 3. How Buvidal is given 4. Possible side effects 5. How to store Buvidal 6. Contents of the pack and other information 1. WHAT BUVIDAL IS AND WHAT IT IS USED FOR Buvidal contains the active substance buprenorphine, which is a type of opioid medicine. It is used to treat opioid dependence in patients who are also receiving medical, social and psychological support. Buvidal is intended for use in adults and adolescents aged 16 years or over. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE BUVIDAL YOU MUST NOT RECEIVE BUVIDAL - if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6) - if you have serious breathing problems - if you have serious liver problems - if you are intoxicated with alcohol or have trembling, sweating, anxiety, confusion or hallucinations caused by alcohol. WARNINGS AND PRECAUTIONS Talk to your doctor before receiving Buvidal if you have: - asthma or other breathing problems - any liver disease such as hepatitis - s Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Buvidal 8 mg prolonged-release solution for injection Buvidal 16 mg prolonged-release solution for injection Buvidal 24 mg prolonged-release solution for injection Buvidal 32 mg prolonged-release solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Buvidal 8 mg prolonged-release solution for injection Each pre-filled syringe contains 8 mg buprenorphine Buvidal 16 mg prolonged-release solution for injection Each pre-filled syringe contains 16 mg buprenorphine Buvidal 24 mg prolonged-release solution for injection Each pre-filled syringe contains 24 mg buprenorphine Buvidal 32 mg prolonged-release solution for injection Each pre-filled syringe contains 32 mg buprenorphine Excipient with known effect The 8 mg, 16 mg, 24 mg and 32 mg strengths contain 95.7 mg of alcohol (ethanol) in each mL (10% w/w). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release solution for injection. Yellowish to yellow clear liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Administration of Buvidal _ _ is restricted to healthcare professionals. Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid dependence therapies. Appropriate precautions, such as to conduct patient follow-up visits with clinical monitoring according to the patient's needs, should be taken when prescribing and dispensing buprenorphine. Take-home use or self-administration of the product by patients is not allowed. 3 Precautions to be taken before initiation of treatment To avoid precipitating symptoms of withdrawal, treatment with Buvidal should be started when objective and clear signs of mild to moderate withdrawal are evident (see section 4.4). Lire le document complet