Methadone Molteni

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Methadone hydrochloride 10 mg/mL

Beschikbaar vanaf:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (Algemene Internationale Benaming):

Methadone hydrochloride 10 mg/mL

Dosering:

10 mg/mL

farmaceutische vorm:

Oral solution

Samenstelling:

Active: Methadone hydrochloride 10 mg/mL Excipient: Brilliant blue FCF Cherry flavour IT1037 Citric acid monohydrate Glycerol Hyetellose Purified water Sodium benzoate Xylitol

Eenheden in pakket:

Bottle, PVC with child resistant closure, 100 mL

klasse:

Class B3 Controlled Drug

Prescription-type:

Class B3 Controlled Drug

Geproduceerd door:

Siegfried Ltd

therapeutische indicaties:

Indicated 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.

Product samenvatting:

Package - Contents - Shelf Life: Bottle, PVC with child resistant closure - 100 mL - 36 months from date of manufacture stored at or below 25°C protect from light 12 months opened stored at or below 25°C protect from light

Autorisatie datum:

2012-03-16

Bijsluiter

1 

METHADONE MOLTENI

17102013

Consumer Medicine Information 

METHADONE MOLTENI 

_METHADONE HYDROCHLORIDE _

Oral solution 1 mg/mL, 5 mg/mL, 10 mg/mL 

WHAT IS IN THIS LEAFLET 

Please
read this leaflet carefully before you start taking Methadone Molteni. 

This  leaflet  answers  some  common  questions  about  Methadone  Molteni.  It  does  not 
contain  all  the  available  information.  The  most  up-to-date  Consumer  Medicine 
Information can be downloaded from www.medsafe.govt.nz. 

Reading this leaflet does not take the place of talking to
your doctor or pharmacist.  

All  medicines  have  risks  and  benefits.  Your  doctor  has  weighed  the risks  of  you  taking 
Methadone Molteni against the benefits this medicine is expected to
have for you.  

IF  YOU  HAVE  ANY  CONCERNS  ABOUT  USING  THIS  MEDICINE,  ASK  YOUR  DOCTOR  OR 
PHARMACIST.  

KEEP THIS LEAFLET WITH THE MEDICINE.  
You may want to read it again. 

WHAT METHADONE MOLTENI IS USED FOR 

Methadone  Molteni  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, 
is a synthetic opiate similar to
morphine because it acts on the central nervous system to 
suppress withdrawal symptoms.  

Methadone  Molteni  must  not  be  used  for  indications  other  than  suppression  of  opioid 
withdrawal symptoms unless approved by your doctor.  
ASK  YOUR  DOCTOR  IF  YOU  HAVE  ANY  QUESTIONS  ABOUT WHY  IT  HAS  BEEN  PRESCRIBED  FOR 
YOU.  

Methadone Molteni is only available on prescription from doctors authorised to prescribe 
Controlled Drugs for the treatment of opioid depe

Productkenmerken

METHADONE MOLTENI
Methadone hydrochloride Oral Solution 1 mg/mL, 5 mg/mL, 10 mg/mL
Page 1 of 14
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
METHADONE MOLTENI 1 mg/mL, 5 mg/mL, 10 mg/mL Oral solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methadone hydrochloride 1 mg/mL, 5 mg/mL, 10 mg/mL
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Methadone Molteni is an oral solution containing methadone
hydrochloride. Each
strength is presented in a 100 mL amber plastic bottle with child
resistant cap in an
outer carton for storage purposes. A measuring device is included, and
a Consumer
Medicine Information leaflet is enclosed in the carton.
The 1 mg/mL strength is coloured green, the 5 mg/mL strength is light
amber and the
10 mg/mL strength is blue.
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
Methadone 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
methadone daily
usually adequately maintains the patient and there generally is no
apparent advantage to
divided doses. However, rapid metabolisers of methadone may not
maintain adequate
plasma methadone concentrations with usual dosing regimens.
Maintenance dosage
requirements should be reviewed regularl