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METHADOSE DILUENT

Active substance(s): NOT APPLICABLE

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1.

NAME OF THE MEDICINAL PRODUCT
Methadose Diluent
Methadone Diluent

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
There is no active ingredient in the product.

3.

PHARMACEUTICAL FORM
Blue solvent for oral administration.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For use as a diluent with Methadone Oral Concentrate 10 mg/1ml and 20 mg/1 ml.

4.2.

Posology and method of administration
For oral administration only.
Dosage Recommendations:
As required.

4.3.

Contraindications
None known.

4.4.

Special warnings and precautions for Use
This product contains parahydroxybenzoates. These may cause allergic reactions (possibly
delayed).

4.5.

Interactions with other medicinal products and other forms of interaction

None known.

4.6.

Pregnancy and lactation
Not applicable.

4.7.

Effects on Ability to drive and use machines
None known.

4.8.

Undesirable Effects
None known.

4.9.

Overdose
Not applicable.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Not applicable.

5.2.

Pharmacokinetic Properties
Not applicable.

5.3.

Pre-clinical Safety Data
None applicable.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Propylene Glycol BP
Propyl Hydroxybenzoate BP
Methyl Hydroxybenzoate BP
Patent Blue V (E131)
Purified Water BP

6.2.

Incompatibilities
None known.

6.3.

Shelf Life
Shelf life - 2 years
Shelf life after first opening container - 3 months.

6.4.

Special Precautions for Storage
Store below 25oC but not in a refrigerator.

6.5.

Nature and contents of container
Bottle:
Closure:
Pack Size:

6.6.

Amber (type III) glass bottle
HDPE, EPE wadded, tamper evident child resistant closure
500ml

Instruction for Use, Handling and Disposal
This product is intended for use as diluent with Methadone Oral Concentrate 10mg/1ml and
20mg/1ml.

7.

MARKETING AUTHORISATION HOLDER

Rosemont Pharmaceuticals Ltd
Rosemont House
Yorkdale Industrial Park
Braithwaite Street
Leeds
LS11 9XE

8.

MARKETING AUTHORIZATION NUMBER
PL 00427/0099

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
31 January 1996

10

DATE OF REVISION OF THE TEXT
11/09/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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