Biodone

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Methadone hydrochloride 2 mg/mL;  

Tilgjengelig fra:

Biomed Limited

INN (International Name):

Methadone hydrochloride 2 mg/mL

Dosering :

2 mg/mL

Legemiddelform:

Oral solution

Sammensetning:

Active: Methadone hydrochloride 2 mg/mL   Excipient: Purified water Sunset yellow FCF

Enheter i pakken:

Bottle, glass, 100 mL

Klasse:

Class B3 Controlled Drug

Resept typen:

Class B3 Controlled Drug

Produsert av:

Saneca Pharmaceuticals AS

Indikasjoner:

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.

Produkt oppsummering:

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

Autorisasjon dato:

1996-01-04

Informasjon til brukeren

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

Preparatomtale

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