Background
Owing to a supply shortage of Dinoprostone 750microgram in 0.75mL ampoules (MSN/2022/012) pharmacy aseptic units may be required to prepare individual patient doses to minimise wastage of the available product.
Aseptic Preparation Worksheet
SPS have developed a patient specific worksheet to support unlicensed pharmacy aseptic units to prepare Dinoprostone 50 micrograms in 50mL Glucose 5% Intravenous Infusion Syringes. The worksheet is intended for single patient use only but does allow for multiple doses to be prepared with a maximum shelf life of 7 days.
Stability and Validation
The proposed shelf life of 7 days is based on a stability study undertaken by the QCNW laboratory. For MS licenced units looking to assign an extended shelf life, the full study which supports physical and chemical stability of the product for up to 30 days may be requested from the NWPQA team The proposed method has not been subject to formal validation.
Method Notes
The method requires the addition of an aliquot of Dinoprostone 1mg/mL concentrate to a 500mL infusion bag, taking into consideration the overage within the bag, to produce a final concentration of 1microgram/mL.
- The preparation method identified in the template worksheet is specific to Baxter Viaflo Infusion bags. Other infusion bags are available.
- The required volume of Dinoprostone 1mg/mL will vary according to the infusion bag average fill volume.
- Dinoprostone 1mg/mL must be filtered via 5 micron filter needle prior to addition to the infusion bag.
For reference: Average fill volumes of Infusion bags are provided in the table below.
| Infusion Bags | Average fill volume of 500mL Infusion bag | Required volume of Dinoprostone 1mg/mL
(Rounded to nearest measurable volume) |
| Baxter Viaflo | 530mL | 0.53mL |
| FK Freeflex | 525mL | 0.53mL |
| FK Steriflex | 525mL | 0.53mL |
| Macopharma EasyFlex N | 516mL | 0.52mL |
| Macopharma Macoflex | 516mL | 0.52mL |