Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-5887 |
| Trade Name | Dose Form | Strength | Identifier |
| Ametop | Topical gel | 4% w/w | |
| Sponsor | Application date | Registration situation | Classification |
| Max Health Limited P O Box 44452 Pt Chevalier Auckland 1246 | 11/11/1996 | Consent given Approval date: 28/10/1999 Labelling exemption expires 15/01/2025 | Pharmacy only |
Composition
| Component | Ingredient | Manufacturer |
| topical gel | Active | |
| Tetracaine hydrochloride 4.551%{relative} equivalent to 4.0% w/w amethocaine base | Siegfried Evionnaz SA Route du Simplon 1, 36 Evionnaz 1902 SWITZERLAND | |
| Excipient | ||
| Monobasic potassium phosphate | ||
| Purified water | ||
| Sodium chloride | ||
| Sodium hydroxide | ||
| Sodium methyl hydroxybenzoate | ||
| Sodium propyl hydroxybenzoate | ||
| Xanthan gum |
Production
| Manufacturing step | Manufacturer |
| Manufacture of Final Dose Form | Perstorp Pharma, Perstorp Specialty Chemicals AB Perstorp SE-284 80 SWEDEN |
| Packing | Perstorp Pharma, Perstorp Specialty Chemicals AB Perstorp SE-284 80 SWEDEN |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Tube, aluminium, | 1.5 g | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 1 months from date of manufacture stored at or below 25°C |
| Tube, aluminium, 12 x 1.5g | 12 dose units | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 1 months from date of manufacture stored at or below 25°C |
Indications
Used to relieve pain when needles are inserted into a vein for giving an injection or taking a blood sample. It can also be used to relieve pain of inserting cannulae for drips.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 3/11/2022 | Changed Medicine Notification | Labelling - Grade 3 | Granted 13/12/2022 | 14/11/2022 |
