Continuous presentation: bounded by unit of presentation; solid dose forms

Examples: vials, ampoules, sachets, containing solid dose forms such as powders or granules which may or may not be dissolved before administration

The unit of presentation usually either uses the same word (even though it is a different concept) as the (package item) container, or the (package item) container is a more granular concept and the unit of presentation uses a less granular term. Strength is expressed as "per one unit of presentation" and the presentation strength and the concentration are exactly the same.

Example: Pack of 10 vials each containing 2g cefotaxime powder for solution for injection

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Manufactured dose form

Powder for solution for injection

Unit of presentation

vial

The vial "bounds" the 2g of the dose form

[Pack size]

10 vials in the carton

Precise active ingredient

cefotaxime sodium

Basis of strength substance

cefotaxime

Presentation strength (logical)

2 g per 1 unit of presentation

Presentation strength

2 g [per 1 vial]

UCUM: 2 g per 1 each

Concentration strength

The concentration of cefotaxime in the powder inside the vial is known to the regulatory agency but is not deemed clinically significant.

Example: Pack of 50 sachets containing 4g of colestyramine powder for oral solution

Manufactured dose form

Powder for oral suspension

Unit of presentation

Sachet

The sachet "bounds" the 4g of the dose form

[Pack size]

50 sachets in the box

Precise active ingredient

colestyramine

Basis of strength substance

colestyramine

Presentation strength (logical)

4 g per 1 unit of presentation

Presentation strength

4 g per 1 sachet

UCUM: 4 g per 1 each

Concentration strength

The concentration of colestyramine in the powder inside the sachet is known to the regulatory agency but not deemed clinically significant

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