dministration 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
White petrolatum USP
6.2 Incompatibilities
None known
6.3 Shelf life
5 years
6.4 Special precautions for storage
Store below 25°C
6.5 Nature and contents of container
Laminate tube supplied with polyethylene tube head and white high density polyethylene tamper evident screw cap closure
Pack size: 4.5G
6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Administrative data
7. Marketing authorisation holder
The Wellcome Foundation Ltd
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
8. Marketing authorisation number(s)
PL 00003/0150
9. Date of first authorisation/renewal of the authorisation
16 October 1996
10. Date of revision of the text
27 September 2016