- Approval Id
- 68db502b4e80844d
- Drug Approval Emc Name
- Methadose Diluent
- Drug Name
- Methadose Diluent
- Company Address
- Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
- Company Website
- http://www.rosemontpharma.com
- Company Telephone
- +44 (0)113 244 1400
- Company Customer Care Direct Line
- +44 (0)800 919 312
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Rosemont Pharmaceuticals Ltd
Rosemont House
Yorkdale Industrial Park
Braithwaite Street
Leeds
LS11 9XE
- Authorisation Number
- PL 00427/0099
- Authorisation Date
- 31 January 1996
- Instruction Authorisation Holder
- Rosemont Pharmaceuticals Ltd
Rosemont House
Yorkdale Industrial Park
Braithwaite Street
Leeds
LS11 9XE
- Instruction Authorisation Number
- PL 00427/0099
- Instruction Authorisation Date
- 31 January 1996
- Instruction Composition
- 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.
- Instruction Dosage Form
- Blue solvent for oral administration.
- Instruction Clinical Particulars
- 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
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Not applicable5.2 Pharmacokinetic properties
Not applicable5.3 Preclinical safety data
Not applicable
- Instruction Pharmaceutical Particulars
- 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\*\*
- Instruction Content
- ## Composition
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
Blue solvent for oral administration.
## Clinical Particulars
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
5.1 Pharmacodynamic properties
Not applicable5.2 Pharmacokinetic properties
Not applicable5.3 Preclinical safety data
Not applicable
## Pharmaceutical Particulars
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\*\*
- Company Detail Path
- /organization/rosemont-pharmaceuticals-limited
