Țară: Noua Zeelandă
Limbă: engleză
Sursă: Medsafe (Medicines Safety Authority)
Methadone hydrochloride 2 mg/mL;
Biomed Limited
Methadone hydrochloride 2 mg/mL
2 mg/mL
Oral solution
Active: Methadone hydrochloride 2 mg/mL Excipient: Purified water Sunset yellow FCF
Bottle, glass, 100 mL
Class B3 Controlled Drug
Class B3 Controlled Drug
Saneca Pharmaceuticals AS
Oral Methadone is used in detoxification and maintenance treatment as a substitute for heroin or other morphine-like drugs to suppress the opiate-agonist abstinence syndrome in patients who are dependent on these drugs.
Package - Contents - Shelf Life: Bottle, glass, - 100 mL - 12 months from date of manufacture stored at or below 25°C - Bottle, glass, - 200 mL - 12 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE container and PP screw cap - 200 mL - 24 months from date of manufacture stored at or below 25°C
1996-01-04
CONSUMER MEDICINE INFORMATION BIODONE, BIODONE FORTE, BIODONE EXTRA FORTE _METHADONE HYDROCHLORIDE 2 MG/ML (BIODONE), 5 MG/ML (BIODONE FORTE) _ _AND 10 MG/ML (BIODONE EXTRA FORTE). _ References to “Biodone” in the following information refer to all strengths. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Biodone. It does not contain all of the available information. It does not take the place of talking to you doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Biodone against the expected benefits that it will have for you. If you have any concerns about taking this medicine, talk to your doctor or pharmacist. Keep this leaflet with your medicine. You may need it again. WHAT BIODONE IS USED FOR AND HOW IT WORKS Biodone is a medicine to be taken by mouth to suppress the craving for opiate-type drugs in people who are addicted to them. Methadone, the active ingredient in Biodone, is a synthetic opiate similar to morphine because it acts on the central nervous system to suppress withdrawal symptoms. Biodone must not be used for indications other than suppression of opioid withdrawal symptoms unless approved by your doctor. Biodone is only available on prescription from doctors authorised to prescribe controlled drugs for the treatment of opioid dependence. Biodone is itself addictive. BEFORE YOU TAKE BIODONE _DO NOT TAKE BIODONE IF _ • You are allergic to methadone or to the colouring substances used. • If your breathing is shallow, especially in the presence of cyanosis (blue coloured skin) or excessive lung secretions. • You are having an attack of asthma. • You have acute a Citiți documentul complet
NEW ZEALAND DATA SHEET BIODONE 2 MG/ML ORAL SOLUTION BIODONE FORTE 5 MG/ML ORAL SOLUTION BIODONE EXTRA FORTE 10 MG/ML ORAL SOLUTION Page 1 of 13 1 PRODUCT NAME Biodone, 2 mg/mL, Oral solution Biodone Forte, 5 mg/mL, Oral solution Biodone Extra Forte, 10 mg/mL, Oral solution References to “Biodone” in this data sheet refer to all strengths. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Methadone hydrochloride 2 mg/mL, 5 mg/mL, 10 mg/mL For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Biodone is an oral solution containing methadone hydrochloride BP and is presented in 200 mL amber glass bottles with tamper-evident caps or in amber plastic bottles with an induction seal under the cap as tamper evidence. Biodone is yellow (due to sunset yellow), Biodone Forte is colourless and Biodone Extra Forte is red (due to permicol red, a diluted form of amaranth). There are no other additives or excipients in Biodone solutions. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral Methadone is used in detoxification and maintenance treatment as a substitute for heroin or other morphine-like drugs to suppress the opiate-agonist abstinence syndrome in patients who are dependent on these drugs. 4.2 DOSE AND METHOD OF ADMINISTRATION Biodone is to be administered by the oral route only. Initial doses should be based on the individual's history of quantity, frequency and route of administration of opiates and should also take into account the person's hepatic and renal functioning. There may be some withdrawal symptoms not covered by the first dose. Initial doses will generally be in the range of 15-35 mg per day and should never be higher than 40 mg. Subsequent dosage should be adjusted according to the requirements and response of the patient. Stabilisation of maintenance dosage usually occurs at 60-120 mg daily although a higher dosage is sometimes required. A single dose of Biodone daily usually adequately maintains the patient and there generally is no apparent advantage to divided doses. However, rapi Citiți documentul complet