Active substance(s): NOT APPLICABLE
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
There is no active ingredient in the product.
Blue solvent for oral administration.
For use as a diluent with Methadone Oral Concentrate 10 mg/1ml and 20 mg/1 ml.
Posology and method of administration
For oral administration only.
Special warnings and precautions for Use
This product contains parahydroxybenzoates. These may cause allergic reactions (possibly
Interactions with other medicinal products and other forms of interaction
Pregnancy and lactation
Effects on Ability to drive and use machines
Pre-clinical Safety Data
List of Excipients
Propylene Glycol BP
Propyl Hydroxybenzoate BP
Methyl Hydroxybenzoate BP
Patent Blue V (E131)
Purified Water BP
Shelf life - 2 years
Shelf life after first opening container - 3 months.
Special Precautions for Storage
Store below 25oC but not in a refrigerator.
Nature and contents of container
Amber (type III) glass bottle
HDPE, EPE wadded, tamper evident child resistant closure
Instruction for Use, Handling and Disposal
This product is intended for use as diluent with Methadone Oral Concentrate 10mg/1ml and
MARKETING AUTHORISATION HOLDER
Rosemont Pharmaceuticals Ltd
Yorkdale Industrial Park
MARKETING AUTHORIZATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
31 January 1996
DATE OF REVISION OF THE TEXT