concentrate for solution for infusion
What Peditrace is and what it is used for
Peditrace is a mixture of trace elements in amounts that are normally absorbed through food.
Peditrace is used to cover the basic needs of trace elements for newborns and children who receive total intravenous nutrition (drip).
What you need to know before using Peditrace
Do not use Peditrace
- if you have Wilson’s disease (a disorder of copper metabolism).
Warnings and cautions
Take special care with Peditrace:
- if you have impaired kidney function
- if you have impaired liver function
- if you have problems with bile secretion.
Other medicines and Peditrace
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
How to use Peditrace
Dosage one of Peditrace is adjusted to the child’s weight and determined by the doctor. Peditrace is given as an intravenous infusion over at least 8 hours.
Possible side effects
Peditrace has no known side effects.
If you still notice any side effects, talk to your doctor or pharmacist.
How to store Peditrace
- Do not store above 25 ° C. Do not freeze.
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
- The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substances are (per ml):
| Zinc chloride | 521 μg |
| Copper chloride 2 H 2 O | 53.7 μg |
| Manganese chloride 4 H 2 O | 3.60 μg |
| Sodium selenite | 4.38 μg |
| Sodium fluoride | 126 μg |
| Potassium iodide | 1.31 μg |
which corresponds to (per ml):
| Zn | 250 μg | 3.82 μmol |
| Cu | 20 μg | 0.315 μmol |
| Mn | 1 μg | 18.2 nmol |
| See | 2 μg | 25.3 nmol |
| F | 57 μg | 3.00 μmol |
| IN | 1 μg | 7.88 nmol. |
The other ingredients are Hydrochloric acid (added to adjust the pH ) and water for injections.
What the medicine looks like and the contents of the pack
Peditrace is a clear, colorless solution found in polypropylene vials.
Pack size: 10 x 10 ml
Marketing Authorization Holder and Manufacturer
Manufacturer
Fresenius Kabi Norge AS, Halden, Norway