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Example 1: A bottle of 56 simvastatin 40mg oral tablets
Manufactured dose form | Oral tablet |
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Unit of presentation | Tablet |
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[Pack size] | 56 tablets in the container
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Precise active ingredient | simvastatin |
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Basis of strength substance | simvastatin |
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Presentation strength (logical) | 40 mg per 1 unit of presentation |
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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 form | Oral tablet |
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Unit of presentation | Tablet |
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[Pack size] | 14 tablets in the blister |
strip2 strip 2 blister strips in the box | 28 tablets in the outer container |
Precise active ingredient | bisoprolol fumarate |
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Basis of strength substance | bisoprolol fumarate |
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Presentation strength (logical) | 5 mg per 1 unit of presentation |
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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 |
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 form | Solution for aerosolisation |
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Unit of presentation | Actuation |
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[Pack size] | 200 actuations in the inhaler |
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Precise active ingredient | salbutamol sulphate |
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Basis of strength substance | salbutamol |
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Presentation strength (logical) | 100 mcg per 1 unit of presentation |
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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 |
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 form | Oral suspension |
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Unit of presentation | 5 mL [spoonful] |
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[Pack size] | 125 mL in the bottle | Not usually expressed as 25 spoonfuls! |
Precise active ingredient | aciclovir |
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Basis of strength substance | aciclovir |
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Presentation strength (logical) | 200 mg per 1 unit of presentation |
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Presentation strength | 200 mg per 5 mL |
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Concentration strength | 40 mg per 1 mL |
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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 form | Powder for solution for injection |
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Unit of presentation | vial | The vial "bounds" the 2g of the dose form |
[Pack size] | 10 vials in the carton |
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Precise active ingredient | cefotaxime sodium |
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Basis of strength substance | cefotaxime |
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Presentation strength (logical) | 2 g per 1 unit of presentation |
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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 2: A pack of 50 sachets containing 4g of colestyramine powder for oral solution
Manufactured dose form | Powder for oral suspension |
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Unit of presentation | Sachet | The sachet "bounds" the 4g of the dose form |
[Pack size] | 50 sachets in the box |
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Precise active ingredient | colestyramine |
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Basis of strength substance | colestyramine |
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Presentation strength (logical) | 4 g per 1 unit of presentation |
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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 |
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 form | Solution for injection |
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Unit of presentation | Ampoule | The ampoule "bounds" the liquid |
[Pack size] | 10 ampoules in the box |
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Precise active ingredient | metoclopramide hydrochloride |
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Basis of strength substance | metoclopramide hydrochloride |
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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 |
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Concentration strength | 5 mg per 1 mL |
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Example 2: A pack of 20 UDVs each containing 2mL of ipratropium bromide for solution for nebulisation
Manufactured dose form | Solution for nebulisation |
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Unit of presentation | Unit dose vial | The vial "bounds" the liquid |
[Pack size] | 5 vials in a sleeve, 4 sleeves in the box |
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Precise active ingredient | ipratropium bromide |
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Basis of strength substance | ipratropium bromide |
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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 |
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Concentration strength | 250 mcg per 1 mL |
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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 form | Solution for injection |
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Unit of presentation | Cartridge | The vial "bounds" the liquid |
[Pack size] | 5 cartridges in a sleeve,1 sleeve in the box |
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Precise active ingredient | insulin soluble human |
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Basis of strength substance | insulin soluble human |
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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 |
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Example 2: A box of 10 bags of Sodium chloride 0.9% solution for infusion 500mL
Manufactured dose form | Solution for injection |
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Unit of presentation | Bag | The bag "bounds" the liquid |
[Pack size] | 1 bag in a sterile pouch,10 pouches in the box |
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Precise active ingredient | sodium chloride |
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Basis of strength substance | sodium chloride |
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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 |
Example 3: A pack of 30 sachets each containing a transdermal patch delivering 4.6mg per 24 hours of rivastigmine
Manufactured dose form | Transdermal patch |
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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 |
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Precise active ingredient | rivastigmine |
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Basis of strength substance | rivastigmine |
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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 |
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 form | Cutaneous cream |
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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 |
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Precise active ingredient | hydrocortisone |
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Basis of strength substance | hydrocortisone |
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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 |
Example 2: A bottle of 5 mL of chloramphenicol eye drops 0.5% w/v in an outer box
Manufactured dose form | Eye drops, solution |
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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 |
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Precise active ingredient | chloramphenicol |
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Basis of strength substance | chloramphenicol |
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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 |
Example 3: A pack of 500g of sterculia 62% w/w granules (EDQM –"granules" = "oral granules")
Manufactured dose form | Oral granules |
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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 |
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Precise active ingredient | sterculia |
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Basis of strength substance | sterculia |
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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 |
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 form | Oral solution |
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Unit of presentation | NOT VALUED | There is nothing that really "bounds" the dose form that delivers the medication "per dose" |
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[Pack size] | 60 ml in the bottle,1 bottle in the box |
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Precise active ingredient | digoxin |
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Basis of strength substance | digoxin |
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Presentation strength (logical) | 3 mg per 60 mL | Not a clinically safe or recognisable expression of strength |
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Presentation strength |
Concentration strength | 50 mcg per 1 mL | Synonym: 0.5 % w/v |
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