Dinoprostone 50 micrograms in 50mL Glucose 5% Syringes for Intravenous Infusion Worksheet

Ian Allen, Pharmacy Quality Assurance Regional Specialist (NW), North West Pharmaceutical Quality AssurancePublished

A example worksheet for preparation of Dinoprostone 50 micrograms in 50mL Glucose 5% Intravenous Infusion Syringes in a pharmacy aseptic unit

 

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

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