concentrate for infusion solution
(Premature neonates or newborn full-term children, infants and children)
What Junyelt is and what it is used for
Junyelt is a concentrate for infusion solution, specially designed for premature or newborn adults, infants, and children.
The solution contains five trace elements (zinc, copper, manganese, iodine, selenium) which are considered essential (basic and vital) because the body cannot produce them but needs small amounts of them to function properly. Trace elements normally come from a balanced diet.
Junyelt is used to give trace elements to premature newborn or newborn full-term infants as well as infants and children who can not eat normally and need intravenous feeding (in a vein).
What you need to know before using Junyelt
Do not use Junyelt
Your child should not receive Junyelt:
- if he / she is allergic (hypersensitive) to any of the ingredients in Junyelt (see section 6 of this leaflet).
- if he / she has Wilson’s disease (a hereditary disease in which there is an excessive amount of copper in the body).
- if he / she has abnormally high levels of any of the ingredients in the blood. (Talk to your doctor if you have any thoughts.)
Warnings and cautions
Talk to your doctor before using Junyelt about your child:
• have any liver or kidney problems.
• have any problems with the thyroid gland.
Blood levels of trace elements are regularly monitored by your doctor during treatment and your doctor adjusts the dosage of Junyelt accordingly.
Other drugs and Junyelt
Tell your doctor if your child is taking, has recently taken, or might be taking any other medicines, including over-the-counter medicines.
Junyelt contains sodium and potassium
This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free. This medicine contains less than 1 mmol (39 mg) per ampoule of potassium, ie it is essentially ‘potassium free.
How to use Junyelt
Junyelt is given to your child intravenously (into a vein) via infusion (IV drip) by a nurse or doctor. They determine an appropriate dose for the baby.
Premature newborns or full-term infants, infants, and children (weight 20 kg or less):
Basic needs for included trace elements are covered by 1 ml June per kg body weight and day up to a maximum dose of 20 ml.
Children (weighing more than 20 kg):
A daily dose of 20 ml of Junyelt should meet the basic needs of trace elements.
Junyelt should be supplemented with a single injection of zinc solution given to premature infants to reach a parenteral intake (directly to the bloodstream) of
450–500 µg zinc per kg and day.
A daily infusion containing iron is recommended when premature infants receive parenteral nutrition for a long time (more than 3 weeks), and a supplement of molybdenum when parenteral nutrition exceeds 4 weeks.
Junyelt should not be given directly to a patient, it must be diluted before use.
If your child gets too much Junyelt
It is very unlikely that your child will receive too much infusion as the doctor or nurse will monitor the child during treatment. If you still think that your child has received too much Junyelt, you should inform your doctor or nurse immediately.
Your doctor will stop treatment with Junyelt and perform the required laboratory tests if an overdose is suspected.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Junyelt can cause side effects, although not everybody gets them.
Tell your doctor if you notice any of the following:
No known frequency (can not be calculated from the available data): Pain at the site of administration.
How to store Junyelt
After dilution, chemical and physical in-use stability has been demonstrated for 48 hours at 25 ° C. From a microbiological point of view, the product should be used immediately after dilution. If the solution is not used immediately, the user is responsible for storage times and conditions of use.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.
Do not freeze.
Do not use this medicine if you notice visible signs of deterioration of the infusion solution.
Medicines 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
The active substances are:
For 10 ml Junyelt (1 ampoule )
Zinc (Zn) 1,000 micrograms (µg) (as zinc gluconate)
Copper (Cu) 200 micrograms (µg) (as copper gluconate)
Manganese (Mn) 5 micrograms (µg) (as manganese gluconate)
Iodine (I) 10 micrograms (µg) (as potassium iodide)
Selenium (Se) 20 micrograms (µg) (as sodium selenite)
The other ingredients are hydrochloric acid and water for injections.
What the medicine looks like and contents of the pack
Junyelt is a clear, colorless concentrate for solution for infusion in a 10 ml ampoule.
Junyelt is delivered in packs of 10 and 50 ampoules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
1 rue Alexander Fleming