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Example 1: A bottle of 56 simvastatin 40mg oral tablets

Manufactured dose formOral tablet
Unit of presentationTablet
[Pack size]56 tablets in the container

Precise active ingredientsimvastatin
Basis of strength substancesimvastatin
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


Example 2: A pack of 28 bisoprolol 5 mg oral tablets contains two blister strips each with 14 tablets

Manufactured dose formOral tablet
Unit of presentationTablet
[Pack size]14 tablets in the blister
strip2
strip
2 blister strips in the box
28 tablets in the outer container
Precise active ingredientbisoprolol fumarate
Basis of strength substancebisoprolol fumarate
Presentation strength (logical)5 mg per 1 unit of presentation
Presentation strength5 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


Continuous presentation: Metered dose unit of presentation

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Example: A single inhaler containing a total of 200 actuations worth of salbutamol, 100 micrograms per actuation, packaged in a box

Manufactured dose formSolution for aerosolisation
Unit of presentationActuation
[Pack size]200 actuations in the inhaler
Precise active ingredientsalbutamol sulphate
Basis of strength substancesalbutamol
Presentation strength (logical)100 mcg per 1 unit of presentation
Presentation strength100 mcg per 1 actuationUCUM: 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

Continuous presentation: Oral liquids designed for administration by "metered" medicine spoon

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Example: A bottle of 125 mL of aciclovir oral suspension 200mg/5mL



Manufactured dose formOral suspension
Unit of presentation5 mL [spoonful]
[Pack size]125 mL in the bottleNot usually expressed as 25 spoonfuls!
Precise active ingredientaciclovir
Basis of strength substanceaciclovir
Presentation strength (logical)200 mg per 1 unit of presentation
Presentation strength200 mg per 5 mL
Concentration strength40 mg per 1 mL

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

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Example 1: A pack of 10 vials each containing 2g cefotaxime powder for solution for injection

Manufactured dose formPowder for solution for injection
Unit of presentationvialThe vial "bounds" the 2g of the dose form
[Pack size]10 vials in the carton
Precise active ingredientcefotaxime sodium
Basis of strength substancecefotaxime
Presentation strength (logical)2 g per 1 unit of presentation
Presentation strength2 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 2: A pack of 50 sachets containing 4g of colestyramine powder for oral solution

Manufactured dose formPowder for oral suspension
Unit of presentationSachetThe sachet "bounds" the 4g of the dose form
[Pack size]50 sachets in the box
Precise active ingredientcolestyramine
Basis of strength substancecolestyramine
Presentation strength (logical)4 g per 1 unit of presentation
Presentation strength4 g per 1 sachetUCUM: 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

Continuous presentation: bounded by container; liquid dose forms

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Example 1: A pack of 10 ampoules each containing 20mL of metoclopramide hydrochloride for solution for injection



Manufactured dose formSolution for injection
Unit of presentationAmpouleThe ampoule "bounds" the liquid
[Pack size]10 ampoules in the box
Precise active ingredientmetoclopramide hydrochloride
Basis of strength substancemetoclopramide hydrochloride
Presentation strength (logical)100 mg per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength100 mg per 20 mL
Concentration strength5 mg per 1 mL
Example 2: A pack of 20 UDVs each containing 2mL of ipratropium bromide for solution for nebulisation

Manufactured dose formSolution for nebulisation
Unit of presentationUnit dose vialThe vial "bounds" the liquid
[Pack size]5 vials in a sleeve, 4 sleeves in the box
Precise active ingredientipratropium bromide
Basis of strength substanceipratropium bromide
Presentation strength (logical)500 mcg per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength500 mcg per 2 mL
Concentration strength250 mcg per 1 mL

Continuous presentation: bounded by container; liquid/semi-solid dose forms; concentration strength required

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Example 1: A pack of 5 cartridges each containing 1.5mL soluble human insulin 100 units/mL solution for injection

Manufactured dose formSolution for injection
Unit of presentationCartridgeThe vial "bounds" the liquid
[Pack size]5 cartridges in a sleeve,1 sleeve in the box
Precise active ingredientinsulin soluble human
Basis of strength substanceinsulin soluble human
Presentation strength (logical)150 units per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength150 units per 1.5 mLNot a clinically safe expression of strength
Concentration strength100 units per 1 mL
Example 2: A box of 10 bags of Sodium chloride 0.9% solution for infusion 500mL

Manufactured dose formSolution for injection
Unit of presentationBagThe bag "bounds" the liquid
[Pack size]1 bag in a sterile pouch,10 pouches in the box
Precise active ingredientsodium chloride
Basis of strength substancesodium chloride
Presentation strength (logical)450 mg per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength450 mg per 500 mLNot a clinically safe expression of strength
Concentration strength9 mg per 1 mLSynonym: 0.9% w/v
Example 3: A pack of 30 sachets each containing a transdermal patch delivering 4.6mg per 24 hours of rivastigmine



Manufactured dose formTransdermal patch
Unit of presentationPatchThe patch "bounds" the dose form that delivers the medication
[Pack size]1 patch in sachet, 30 sachets in the box
Precise active ingredientrivastigmine
Basis of strength substancerivastigmine
Presentation strength (logical)9 g per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength9 g per (5cm) patchNot a clinically safe expression of strength
Concentration strength4.6 mg per 24 hoursThis is a "rate" strength

Continuous presentation: unbounded by container

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Example 1: A 30g tube of hydrocortisone 1% cutaneous cream w/w in an outer box

Manufactured dose formCutaneous cream
Unit of presentationNOT VALUEDThere 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
Precise active ingredienthydrocortisone
Basis of strength substancehydrocortisone
Presentation strength (logical)300 mg per 30 gNot a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength10 mg per 1 gSynonym: 1.0 % w/w
Example 2: A bottle of 5 mL of chloramphenicol eye drops 0.5% w/v in an outer box



Manufactured dose formEye drops, solution
Unit of presentationNOT VALUEDThere 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
Precise active ingredientchloramphenicol
Basis of strength substancechloramphenicol
Presentation strength (logical)25 mg per 5 mLNot a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength5 mg per 1 mLSynonym: 0.5 % w/v
Example 3: A pack of 500g of sterculia 62% w/w granules (EDQM –"granules" = "oral granules")

Manufactured dose formOral granules
Unit of presentationNOT VALUEDThere is nothing that really "bounds" the dose form that delivers the medication "per dose"
[Pack size]500 g in the box
Precise active ingredientsterculia
Basis of strength substancesterculia
Presentation strength (logical)310 g per 500 gNot a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength620 mg per 1 gSynonym: 62 % w/w


Example 4: A bottle of 60 mL of digoxin oral solution 50mcg/mL in an outer box (which has an oral syringe in it)

Manufactured dose formOral solution
Unit of presentationNOT VALUEDThere 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 ingredientdigoxin
Basis of strength substancedigoxin
Presentation strength (logical)3 mg per 60 mLNot a clinically safe or recognisable expression of strength
Presentation strength
Concentration strength50 mcg per 1 mLSynonym: 0.5 % w/v