Aciclovir Intraveous Infusion (Pfizer)
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
05-10-2011
Send request.
Active ingredient:
Aciclovir 25 mg/mL;
Available from:
Pfizer New Zealand Limited
INN (International Name):
Aciclovir 25 mg/mL
Dosage:
25 mg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Aciclovir 25 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection
Units in package:
Polyamp, 5x10 mL ampoule in foil sachet, 50 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Assia Chemical Industries Ltd
Product summary:
Package - Contents - Shelf Life: Polyamp, 5x10 mL ampoule in foil sachet - 50 mL - 2 years from date of manufacture stored at or below 25°C 9 months unopened stored at or below 25°C. out of foil sachet - Polyamp, 6x20 mL ampoule in foil sachet - 120 mL - 2 years from date of manufacture stored at or below 25°C 9 months unopened stored at or below 25°C. out of foil sachet
Authorization date:
1998-06-02
Summary of Product characteristics
Datasheet
ACICLOVIR INTRAVENOUS INFUSION
Page 1 of 6
March 2004
ACICLOVIR INTRAVENOUS INFUSION
Aciclovir Sodium 25mg/mL
PRESENTATION
Aciclovir Intravenous Infusion is a clear, colourless to pale yellow, sterile, isotonic, preservative-free,
aqueous solution. Aciclovir Intravenous Infusion contains aciclovir, sodium chloride (for isotonicity) and
Water for Injections BP. It does not contain preservatives.
USES
_Actions _
Aciclovir is an antiviral agent which is active _in vitro_ against _Herpes simplex_ (HSV) types I and II and
_Varicella zoster_ virus (VZV). However, the relationship between _in vitro_ sensitivity of herpes viruses to
Aciclovir and clinical response to therapy has yet to be established. Aciclovir needs to be phosphorylated
to the active compound, aciclovir triphosphate, in order to become active against the virus. Such
conversion is very limited in normal cells and in addition cellular DNA polymerase is not very sensitive
to the active compound. However, in infected cells HSV or VZV coded thymidine kinases facilitates the
conversion of aciclovir to aciclovir monophosphate which is then converted to aciclovir triphosphate by
cellular enzymes. Aciclovir triphosphate acts as an inhibitor of, and substrate for, the herpes specified
DNA polymerase, preventing further viral DNA synthesis.
Animal studies indicate that at high doses aciclovir is
cytotoxic.
_Pharmacokinetics _
In adults the terminal plasma half-life of aciclovir after intravenous administration is about 2.9 hours.
Approximately 60% of the drug is excreted unchanged by the kidney by glomerular filtration and tubular
excretion. When aciclovir is given
Read the complete document
