Additional Points To Consider For Parenteral Preparations

8.2 Additional Points To Consider For Parenteral Preparations:

■ There should be a minimal need for complex calculations for prescribing, dispensing and administration (e.g. dose in micrograms/kg/hour prescribed to be converted to volume per hour administered; conversion between mmol prescribed and mg on the label; conversion between mg prescribed and percentage concentration on the label; and decimal points).

■ The need for additional steps in the preparation of the product for administration should be minimized, for example, by developing ready-to-use preparations.

■ Measurement of volumes smaller than 0.1 ml should not be required. Dose volumes in hundredths of a millilitre should be avoided. Tables should be included in the product information clearly stating the
dose and the volume to be measured, and how this can be achieved safely and accurately.

■ Miscalculation can lead to overdose and the amount of the API in the presentation should not allow administration of a critical overdose to the smallest patient for whom the presentation is intended.

■ Using several vials per dose or large vials that may contain several doses should be avoided if possible.

■ Other methods of preventing overdose of critical medicines can be explored and presented for consideration, e.g. tables of weight, dose (mass) and volume (ml) of preparation required.

■ Safety measures and restrictions on administration via central or peripheral cannula should be provided, including advice on maximum and minimum dilutions for safe administration.

■ Consideration should be given to the contribution to the child’s fluid and electrolyte balance due to the medicine administration volume and/or electrolyte content.

■ Compatibility with other medicines that are part of a standard care plan should be investigated.

■ Information on pH of the FPP needs to be provided in the product information.

Development of Paediatric Medicines: points to consider in formulation, 
(Annex 5, WHO Technical Report Series 970, 2012)

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