employed therapeutically. Two generation studies in mice did not reveal any effect of aciclovir on fertility. There is no experience of the effect of Aciclovir Suspension on human female fertility. Aciclovir Suspension has been shown to have no definite effect upon sperm count, morphology or motility in man.
Teratogenicity
Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rats, rabbits or mice.
In a non-standard test in rats, foetal abnormalities were observed, but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.
6. Pharmaceutical particulars
6.1 List of excipients
Sodium methyl hydroxybenzoate (E219)
Sodium propyl hydroxybenzoate (E217)
Citric acid monohydrate (E330)
Xanthan gum (E415)
Liquid maltitol (E965)
Compound orange spirit
Vanillin
Purified water.
6.2 Incompatibilities
None known
6.3 Shelf life
24 months – unopened
1 month - opened
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Bottle: Amber (Type III) glass
Closures: HDPE, EPE wadded, tamper evident, child resistant closure
Pack: 125ml
6.6 Special precautions for disposal and other handling
Keep out of the reach of children. Shake well before use.
7. Marketing authorisation holder
Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE
8. Marketing authorisation number(s)
PL 00427/0119
9. Date of first authorisation/renewal of the authorisation
21.09.04
10. Date of revision of the text
05/09/2016
