Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium hydroxide (used to adjust pH)
6.2   Incompatibilities

The reconstituted concentrate and diluted solution for infusion must not be mixed with other medicinal products except those mentioned in Section 6.6.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.

6.4   Special precautions for storage
Store below 25oC
6.5   Nature and contents of container
Type I glass vials closed with butyl or bromobutyl rubber stoppers secured by aluminium collars.

6.6   Special precautions for disposal and other handling
Reconstitution: Zovirax I.V. should be reconstituted using the following volumes of either Water for Injections BP or Sodium Chloride Intravenous Injection BP (0.9% w/v) to provide a solution containing 25 mg aciclovir per ml:
Formulation             Volume of fluid for reconstitution
250 mg vial             10 ml


From the calculated dose, determine the appropriate number and strength of vials to be used. To reconstitute each vial add the recommended volume of infusion fluid and shake gently until the contents of the vial have dissolved completely.
Administration:
The required dose of Zovirax I.V. should be administered by slow intravenous infusion over a one-hour period.
After reconstitution Zovirax I.V. may be administered by a controlled-rate infusion pump.
Alternatively, the reconstituted solution may be further diluted to give an aciclovir concentration of not greater than 5 mg/ml (0.5% w/v) for administration by infusion: Add the required volume of reconstituted solution to the chosen infusion solution, as recommended below, and shake well to ensure adequate mixing occurs.
For children and neonates, where it is advisable to keep the volume of infusion fluid to a minimum, it is recommended that dilution is on the basis of 4 ml reconstituted solution (100 mg aciclovir) added to 20 ml of infusion fluid.
For adults, it is recommended that infusion bags containing 100 ml of infusion fluid are used, even when this would give an aciclovir concentration substantially below 0.5% w/v. Thus one 100 ml infusion bag may be used for any dose between 250 mg and 500 mg aciclovir (10 and 20 ml of reconstituted solution) but a second bag must be used for doses between 500 mg and 1000 mg.
When diluted in accordance with the recommended schedules, Zovirax I.V. is known to be compatible with the following infusion fluids and stable for up to 12 hours at room temperature (15°C to 25°C):
Sodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v)
Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion BP Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion BP Compound Sodium Lactate Intravenous Infusion BP (Hartmann's Solution).
Zovirax I.V. when diluted in accordance with the above schedule will give an aciclovir concentration not greater than 0.5% w/v.
Since no antimicrobial preservative is included, reconstitution and dilution must be carried out under full aseptic conditions, immediately before use, and any unused solution discarded.
Should any visible turbidity or crystallisation appear in the solution before or during infusion, the preparation should be discarded.