Revised: 26 August 2026
Medicines
Medsafe Product Detail |
||
|---|---|---|
| File ref: TT50-4804/1 |
| Trade Name | Dose Form | Strength | Identifier |
|---|---|---|---|
| Peditrace | Solution for infusion | . | |
| Sponsor | Application date | Regulatory status | Classification |
| Fresenius Kabi New Zealand Limited c/o GNZCC HSBC Tower, Level 14 188 Quay Street Auckland 1010 |
12/05/1995 | Approval lapsed Approval date:21/06/1995 Notification date: 5/08/2021 |
General sale |
Composition
| Component | Ingredient | Manufacturer |
|---|---|---|
| solution for infusion | Active | |
| Copper chloride dihydrate 53.7 µg/mL equivalent to 20 µg/0.315 µmol Cu/mL | Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Manganese chloride tetrahydrate 3.6 µg/mL (Tetrahydrate, =1µg/18.2nmol Mn/mL) | Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Potassium iodide 1.31 µg/mL equivalent to 1 µg/7.88 nmol I/mL | Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Sodium fluoride 126 µg/mL equivalent to 57 µg/3.0 µmol F/mL | Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Sodium selenite 4.38 µg/mL (Anhydrous =2µg/25.3nmol Se/mL) | Retorte GmbH Selenium Chemicals & Metals Sulzbacher Strasse 45 Rothenbach D-90552 GERMANY | |
| Zinc chloride 521 µg/mL equivalent to 250 µg/3.82 µmol Zn/mL | Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Excipient | ||
| Hydrochloric acid | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
|---|---|
| Manufacture of Active Ingredient | Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY |
| Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Retorte GmbH Selenium Chemicals & Metals Sulzbacher Strasse 45 Rothenbach D-90552 GERMANY | |
| Manufacture of Final Dose Form | Fresenius Kabi Norge AS Svinesundveien 80 Halden NO-1788 NORWAY |
| Packing | Fresenius Kabi Norge AS Svinesundveien 80 Halden NO-1788 NORWAY |
| Secondary Packaging | Pharmaco (NZ) Ltd 4 Fisher Crescent Mt Wellington AUCKLAND 1060 |
| NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
| Package | Contents | Shelf life |
|---|---|---|
| Vial, plastic, 10 x 10mL | 100 mL | 36 months from date of manufacture stored at or below 25°C |
Indications
Peditrace is indicated in premature and full-term infants and children needing intravenous nutrition to supply the basal requirements of trace elements.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
|---|---|---|---|---|---|
| 1/10/2015 | Changed Medicine Notification | Active ingredient manufacturing process - Grade 3; Administrative fee (CMN) | Granted | 9/10/2015 |
