Methadose Diluent
Marketing Authorization Holder: Rosemont Pharmaceuticals Ltd Rosemont House Yorkdale Industrial Park Braithwaite Street Leeds LS11 9XE
Prescription only medicine
Not classified
PL 00427/0099
Summary of Product Characteristics
Detailed prescribing information and pharmaceutical guidance from the UK Electronic Medicines Compendium.
Composition
Active and inactive ingredients
There is no active ingredient in the product Excipient(s) with known effect: Propyl Hydroxybenzoate (E216) – 1.5mg/5ml Methyl Hydroxybenzoate (E218) – 6mg/5ml Propylene Glycol (E1520) – 155.6mg/5ml For a full list of excipients, see section 6.1.
Pharmaceutical Form
Dosage form and administration route
Blue solvent for oral administration.
Clinical Particulars
Therapeutic indications and usage
4.1 Therapeutic indications For use as a diluent with Methadone Oral Concentrate 10mg/1ml and 20mg/1ml4.2 Posology and method of administration For oral administration only. **Dosage recommendations** As required.4.3 Contraindications None known4.4 Special warnings and precautions for use Excipients warnings: • Methyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed). • Propylene Glycol. This medicine contains 155.6mg propylene glycol in each 5 ml dose.4.5 Interaction with other medicinal products and other forms of interaction None known4.6 Fertility, pregnancy and lactation Not applicable4.7 Effects on ability to drive and use machines None known4.8 Undesirable effects None known4.9 Overdose Not applicable
Pharmacological Properties
Pharmacodynamics and pharmacokinetics
5.1 Pharmacodynamic properties Not applicable5.2 Pharmacokinetic properties Not applicable5.3 Preclinical safety data Not applicable
Pharmaceutical Particulars
Storage and handling information
6.1 List of excipients Propylene Glycol BP Propyl Hydroxybenzoate BP Methyl Hydroxybenzoate BP Patent Blue V (E131) Purified Water BP6.2 Incompatibilities None known6.3 Shelf life Shelf life- 2 years Shelf life after first opening container - 3 months6.4 Special precautions for storage Store below 25°C but not in a refrigerator6.5 Nature and contents of container Bottle: Amber (type III) glass bottle Closure: HDPE, EPE wadded, tamper evident child resistant closure Pack Size: 500ml6.6 Special precautions for disposal and other handling This product is intended for use as a diluent with Methadone Oral Concentrate 10mg/1ml and 20mg/1ml **Administrative Data**