MANNITOL SUSPENSION VEHICLE FOR DE-CAPEPTYL SR INJECTION, MANNITOL SOLUTION 0.8% FOR INJECTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Mannitol Solution 0.8 % for Injection.

Other licensed names

Mannitol Suspension Vehicle for De-Capeptyl SR Injection.

Note (for use only with the De-Capeptyl SR product range).

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

No active ingredient.

3 PHARMACEUTICAL FORM

A clear, colourless, sterile liquid.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Not applicable.

4.2 Posology and method of administration

None stated.

4.3 Contraindi­cations

None stated.

4.4 Special warnings and precautions for use

None stated.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Pregnancy and lactation

None stated.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

None stated.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

None stated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

None stated.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Mannitol,

Water for injections

6.2 Incompatibilities

None stated.

6.3 Shelf life

3 years.

After reconstitution, chemical and physical in use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.

6.4 Special precautions for storage

None

6.5 Nature and contents of container

-A 2 ml type 1glass ampoule containing a clear, colourless, sterile liquid.

-A 3 ml type 1 glass ampoule containing a clear, colourless, sterile liquid.

6.6 Special precautions for disposal

For use in combination with other products to be injected in accordance with instructions accompanying those products.

7 MARKETING AUTHORISATION HOLDER

Ipsen Limited

190 Bath Road

Slough

SL1 3XE

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 34926/0008