MANNITOL SOLUTION 0.8% FOR INJECTION
Active substance(s): LANREOTIDE ACETATE
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).
QUALITATIVE AND QUANTITATIVE COMPOSITION
No active ingredient.
A clear, colourless, sterile liquid.
Posology and method of administration
Special warnings and precautions for use
Interaction with other medicinal products and other forms of interaction
Pregnancy and lactation
Effects on ability to drive and use machines
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
Preclinical safety data
List of excipients
Water for injections
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.
Special precautions for storage
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.
Special precautions for disposal
For use in combination with other products to be injected in accordance with
instructions accompanying those products.
MARKETING AUTHORISATION HOLDER
190 Bath Road
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
13 November 2001
DATE OF REVISION OF THE TEXT