enile toxicity.
In terms of reproductive development, growth and neurological development there were no
propranolol-related effects or toxicologically significant findings at 40 mg/kg/day, correlating to safety margins of 1.2 in females and 2.9 in males, based on mean propranolol exposures on PND 21.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
· Hydroxyethylcellulose
· Sodium saccharin
· Strawberry flavour (contains propylene glycol)
· Vanilla flavour (contains propylene glycol)
· Citric acid monohydrate
· Purified water
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf life
Before opening: 3 years.
After first opening: 2 months.
6.4 Special precautions for storage
Keep the bottle in the original carton in order to protect from light. Do not freeze.
Store the bottle and the syringe together in the carton box between each use.
6.5 Nature and contents of container
120 mL solution, in an amber-glass bottle fitted with a low density polyethylene insert and a child resistant polypropylene screw cap, provided with a polypropylene oral syringe graduated in mg of propranolol base.
Pack size: 1.
6.6 Special precautions for disposal
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
PIERRE FABRE DERMATOLOGIE
45 place Abel Gance
F- 92100 Boulogn
8 MARKETING AUTHORISATION NUMBER(S)
EU/1/14/919
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation:
10 DATE OF REVISION OF THE TEXT
Detailed information on this medicinal product is available on the website of the European Medicines
Agency http://www.ema.europa.eu.
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