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.
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
Unit of presentation
Sachet
The sachet "bounds" the 4g of the dose form
[Pack size]
50 sachets in the box

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.
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


To correctly interpret "one countable instance of a whole of medicinal product ", it is important that this is seen in the context of the overall description of a medicinal product, which is always presented from the manufacturer as a "packaged medicinal product". Note that description of packaged medicinal products is outside the scope of the international release but may be included within a national extension. The IDMP Medicinal Product model describes this, showing how the Manufactured Item is related to the Packaged Medicinal Product via the Package Item (Container). This is a recursive class that represents both the package as supplied by the manufacturer (and, for example, labelled with the GTIN, the batch number and the expiry), and through a recursive relationship, with any sub-packages inside the outer pack.
By describing the various standard patterns of products with their basic dose forms and intimate containers, consistent representation of strength based on unit of presentation can be maintained.


Examples: oral solutions, suspensions, emulsions, syrups
This is a variation on the metered dose presentation; the unit of presentation supplied by the manufacturer to provide the “metered dose” is the 5mL spoonful, since this represents “the quantity of product that is administered by filling a single spoon administration device” [EDQM]. Strength is expressed as “per one unit of presentation” (per 5 mL [spoonful]) BUT the presentation strength and the concentration are NOT the same, since these are continuous liquids, so the concentration strength of “per 1 mL” will usually be a different value. Note that explicit representation of the medicine spoon would be as an administration device, and is therefore out of scope of the international Medicinal Product hierarchy. National extensions may wish to represent the inclusion of a medicine spoon (or indeed any other administration device such as an applicator) in the package description (as in IDMP, for example) should the use case(s) require.
Example: A bottle of 125 mL of aciclovir oral suspension 200mg/5mL
aciclovir
Presentation strength (logical)
200 mg per 1 unit of presentation
Presentation strength
200 mg per 5 mL
Concentration strength
40 mg per 1 mL
Unit of presentation
5 mL [spoonful]
[Pack size]
125 mL in the bottle
Not usually expressed as 25 spoonfuls!
Precise active ingredient
aciclovir

Basis of strength substance
Examples: parenteral solutions, unit dose nebuliser solutions
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. Presentation strength is expressed as "per the amount of liquid bounded by the unit of presentation" but concentration strength is per mL (and therefore is often different).
metoclopramide hydrochloride
Presentation strength (logical)
100 mg per volume contained in the unit of presentation
The amount of the dose form bounded in the unit of presentation
Presentation strength
100 mg per 20 mL
Concentration strength
5 mg per 1 mL
Precise active ingredient
ipratropium bromide
Basis of strength substance
ipratropium bromide
Presentation strength (logical)
500 mcg per volume contained in the unit of presentation
The amount of the dose form bounded in the unit of presentation
Presentation strength
500 mcg per 2 mL
Concentration strength
250 mcg per 1 mL
Unit of presentation
Ampoule
The ampoule "bounds" the liquid
[Pack size]
10 ampoules in the box
Precise active ingredient
metoclopramide hydrochloride
Unit of presentation
Unit dose vial
The vial "bounds" the liquid
[Pack size]
5 vials in a sleeve, 4 sleeves in the box


Basis of strength substance
Examples: various inhalers, nasal sprays, some cutaneous sprays/foams
The unit of presentation is the actuation, the “single operation of a metered-dose pump, valve or other equivalent dosing mechanism” [EDQM].
Strength is expressed as “per one unit of presentation” and the presentation strength and the concentration are exactly the same.
Examples: various tablets, capsules, cachets, pessaries, suppositories, tampons
The unit of presentation is usually a less granular term than the manufactured dose form, and often corresponds to the basic dose form. Strength is expressed as "per one unit of presentation" and the presentation strength and the concentration are exactly the same.
Precise active ingredient
bisoprolol fumarate
Basis of strength substance
bisoprolol fumarate
Presentation strength (logical)
5 mg per 1 unit of presentation
Presentation strength
5 mg [per 1 tablet]
UCUM: 5 mg [per 1 each]
Concentration strength
The weight of the tablet is not usually known so concentration strength is not usually available and is not deemed clinically significant
Unit of presentation
Tablet
[Pack size]
56 tablets in the container
Precise active ingredient
simvastatin
Basis of strength substance
simvastatin
Presentation strength (logical)
40 mg per 1 unit of presentation
Presentation strength
40 mg [per 1 tablet]
UCUM: 40 mg [per 1 each]
Concentration strength
The weight of the tablet is not usually known so concentration strength is not usually available and is not deemed clinically significant
Unit of presentation
Tablet
[Pack size]
14 tablets in the blister strip 2 blister strips in the box


28 tablets in the outer container

salbutamol
Presentation strength (logical)
100 mcg per 1 unit of presentation
Presentation strength
100 mcg per 1 actuation
UCUM: 100 mcg per 1 each
Concentration strength
The concentration of salbutamol sulphate in the inhalant solution inside the inhaler container is probably known to the regulatory agency but is not deemed clinically significant.
Unit of presentation
Actuation
[Pack size]
200 actuations in the inhaler
Precise active ingredient
salbutamol sulphate

Basis of strength substance
Examples: bulk parenteral solutions, insulins, patches
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. However, although presentation strength is expressed as "per one unit of presentation", the clinically relevant strength is the concentration strength, as almost all are used in individually calculated and variable amounts. Note that the unit of presentation is likely to be useful in description of the medicinal product concept at some level; insulin presented in a multi-dose vial will be used/administered differently from insulin presented in a cartridge for use within a "pen device".
Unit of presentation
Cartridge
The vial "bounds" the liquid
[Pack size]
5 cartridges in a sleeve,1 sleeve in the box
Precise active ingredient
insulin soluble human
Unit of presentation
Bag
The bag "bounds" the liquid
[Pack size]
1 bag in a sterile pouch,10 pouches in the box
Unit of presentation
Patch
The patch "bounds" the dose form that delivers the medication
[Pack size]
1 patch in sachet, 30 sachets in the box




Basis of strength substance
insulin soluble human
Presentation strength (logical)
150 units per volume contained in the unit of presentation
The amount of the dose form bounded in the unit of presentation
Presentation strength
150 units per 1.5 mL
Not a clinically safe expression of strength
Concentration strength
100 units per 1 mL
Precise active ingredient
sodium chloride
Basis of strength substance
sodium chloride
Presentation strength (logical)
450 mg per volume contained in the unit of presentation
The amount of the dose form bounded in the unit of presentation
Presentation strength
450 mg per 500 mL
Not a clinically safe expression of strength
Concentration strength
9 mg per 1 mL
Synonym: 0.9% w/v
Precise active ingredient
rivastigmine
Basis of strength substance
rivastigmine
Presentation strength (logical)
9 g per volume contained in the unit of presentation
The amount of the dose form bounded in the unit of presentation
Presentation strength
9 g per (5cm) patch
Not a clinically safe expression of strength
Concentration strength
4.6 mg per 24 hours
This is a "rate" strength


Examples: bulk powders and granules, bulk liquids, semi-solids
These presentations are not particularly bound by their container in any way that is meaningful in terms of their use or administration; the Manufactured Item is a continuous presentation and almost all are used in individually calculated and variable amounts.
For example,
Hydrocortisone cream for cutaneous use is contained in a tube, but its use is based on how much is squeezed out and applied to the skin.
Chloramphenicol eye drops are presented in a dropper bottle, but they are administered drop by drop and although the dropper bottle aims to deliver a roughly uniform sized drop to the eye, they are not "metered dose containers" in the way that containers with valves are.
A unit of presentation is not usually given for these products. The pack size (not relevant for SNOMED international model) is given as the Manufactured Item quantity. Strength is expressed as a concentration and as such the presentation strength and the concentration are exactly the same.
Unit of presentation
NOT VALUED
There is nothing that really "bounds" the dose form that delivers the medication "per dose"
[Pack size]
30 g in the tube,1 tube in the box
Unit of presentation
NOT VALUED
There is nothing that really "bounds" the dose form that delivers the medication "per dose"
[Pack size]
5 ml in the dropper bottle,1 bottle in the box
Unit of presentation
NOT VALUED
There is nothing that really "bounds" the dose form that delivers the medication "per dose"
[Pack size]
500 g in the box
Unit of presentation
NOT VALUED
There is nothing that really "bounds" the dose form that delivers the medication "per dose"
[Pack size]
60 ml in the bottle, 1 bottle in the box
Precise active ingredient
hydrocortisone
Basis of strength substance
hydrocortisone
Presentation strength (logical)
300 mg per 30 g
Not a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength
10 mg per 1 g
Synonym: 1.0 % w/w
Precise active ingredient
chloramphenicol
Basis of strength substance
chloramphenicol
Presentation strength (logical)
25 mg per 5 mL
Not a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength
5 mg per 1 mL
Synonym: 0.5 % w/v
Precise active ingredient
sterculia
Basis of strength substance
sterculia
Presentation strength (logical)
310 g per 500 g
Not a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength
620 mg per 1 g
Synonym: 62 % w/w
Precise active ingredient
digoxin
Basis of strength substance
digoxin
Presentation strength (logical)
3 mg per 60 mL
Not a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength
50 mcg per 1 mL
Synonym: 0.5 % w/v




