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PACKAGE LEAFLET: INFORMATION FOR THE USER

Peditrace® concentrate for solution for infusion

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

in this leaflet:

1.    What is Peditrace® and what it is used for

2.    Before your child receives Peditrace®

3.    How your child will be given Peditrace®

4.    Possible side effects

5.    How Peditrace® is stored

6.    Further information

1. WHAT IS PEDITRACE® AND WHAT IT IS USED FOR

Peditrace® is especially designed for babies and children. It provides trace elements to your child when they cannot eat normally.

It is usually used as part of a balanced intravenous diet, together with proteins, fats, carbohydrates, salts and vitamins.

2. BEFORE YOUR CHILD RECEIVES PEDITRACE®

Your child should not receive Peditrace®:

•    if he /she is allergic (hypersensitive) to Peditrace® or to any of its ingredients mentioned in Section 6. if you develop a rash or other allergic reactions (like Itching, swollen lips or face or shortness of breath), please inform your doctor.

•    if he/she suffers from Wilson's Disease (an inherited disorder where there is excessive amount of copper in the body's tissue)

Peditrace® must be diluted before use. It will be added to another solution before it is given to your child. Your doctor or nurse will make sure it is prepared correctly.

Care should be taken when administering Peditrace®

Tell your doctor if your child:

•    has got any liver or kidney problems

Your doctor may want to do regular blood tests to check your child's condition.

Taking other medicines

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.

3. HOW YOUR CHILD WILL BE GIVEN PEDITRACE®

Your child will receive this medicine by infusion (IV drip). Peditrace® will be added to an amino acid or glucose solution before it is given to your child. Your doctor will decide on the correct dose for him/her to receive.

Dosage

For Infants and children up to 15 kg bodywelght

The usual daily dose of Peditrace® is 1 ml for every kg of body weight. The maximum dose is 15ml/ day.

For children of 15-40 kg bodywelght

The daily dose is 15ml/day.

Another trace element solution called Additrace® is more suitable for children weighing over 40 kilograms.

if your child receives too much Peditrace®

It is very unlikely that your child will receive more infusion than he/she should as the doctor or nurse will monitor him/her during the treatment. However if you think that your child has received too much Peditrace®, inform the doctor or nurse immediately. Symptoms of overdose include: headache, nausea, vomiting and drowsiness.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

15816012G.indd 1    2013-04-02

RECTO

MASTER ARTWORK/LABEL SPECIFICATION

FYV 1981

01-58-16-012C

563/5224 (010001101001)

Black

3600 x 84 mm folded to 120 x 48 mm 08.22.B

Draft: 4,2013-04-02

4.    POSSIBLE SIDE EFFECTS

No known undesirable side effects have been reported with the use of Peditrace®

However, If you notice any unwanted effects, please tell your doctor or nurse straight away.

5.    HOW PEDITRACE⁰ IS STORED

Keep out of the reach and sight of children

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Peditrace® infusion. Do not store above 25 °C. Do not freeze. Keep container in the outer carton. The solution must not be used after the expiry date shown on the carton and the vial labels.

Do not use the solution if it is cloudy or contains particles.

The expiry date refers to the last day of that month. Any solution remaining after treatment should be disposed of via approved hospital procedures.

6. FURTHER INFORMATION

What Peditrace® Infusions contain

Each 1 ml contains: Zinc Chloride	521	micrograms
Copper Chloride 2H20	53.7	micrograms
Manganese Chloride 4H20	3.60	micrograms
Sodium Selenite Anhydrous	4.38	micrograms
Sodium Fluoride	126	micrograms
Potassium Iodide	1.31	micrograms
The active ingredients in 1 ml correspond to;
Zinc	250	micrograms	3.82	micromol
Copper	20	micrograms	0.315	micromol
Manganese	1	micrograms	18.2	nanomol
Selenium	2	micrograms	25.3	nanomol
Fluoride	57	micrograms	3.0	micromol
iodide	1	micrograms	7.88	nanomol

What Peditrace® looks like and contents of the pack

Peditrace® is a sterile clear, colourless solution containing trace elements. Each plastic vial contains 10 ml of solution. Each carton contains 10 vials.

Marketing authorisation holder

Fresenius Kabi Limited Cestrian Court Eastgate Way Manor Park Runcorn Cheshire WA71NT UK

Manufacturer:

Fresenius Kabi Norge AS NO-1753 Halden Norway

This leaflet was revised in April 2013