A4 : Product Description
Jauze
- State briefly on visual and physical characteristics of the product.
- For injections packed with diluent, description of the product must include description of the diluent
- Description must include the appearance after the product is diluted/mixed with water or other proposed diluents(s) (for suspension, powder for injection etc)
- Explain the markings for tablet, the meaning of the logo, can the tablet be cut into half or not (scoring should suit its dosing)
- If the scored tablet is not meant to be cut, this should be stated in A4.
- If capsule, to describe capsule contents
- Different strengths of tablets should have different sizes. Should state size (mm unit, etc) for each strength of tablet and the size should not be the same.
|
No. |
Dosage Form |
Description |
|
1. |
Tablet |
Shape, size, colour, odour, taste, marking, emboss, type of tablet (e.g. coated, uncoated, film, sugar etc.) |
|
2. |
Capsule |
Shape, size, colour, odour, taste, marking, emboss, coating, content of capsule, type of capsule (e.g.: soft, hard, chewable etc.) |
|
3. |
Liquid |
Clarity, type (e.g. solution/ suspension/ emulsion etc.), taste, odour, colour. |
|
4. |
Powder |
Colour, odour, taste etc. |
|
5. |
Pill |
Colour, odour, taste, size etc. |
|
6. |
Granules |
Colour, odour, taste, size etc. |