Vitalipid

Package leaflet: Information for the user

VITALIPID Adult Concentrate for emulsion for infusion

VITALIPID Children Concentrate for emulsion for infusion
Mixture of fat-soluble vitamins
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What VITALIPID is and what it is used for
2. What you need to know before using VITALIPID
3. How to use VITALIPID
4. Possible side effects
5. How to store VITALIPID
6. Contents of the pack and other information

1. What VITALIPID is and what it is used for

VITALIPID is a mixture of vitamins belonging to the group of fat-soluble vitamins, which are essential for the body.
This medicinal product is used when nutrition is provided by direct intravenous administration of nutrients, in patients requiring supplementation with the fat-soluble vitamins A (retinol), D (ergocalciferol), E (tocopherol), and K (phytomenadione).
VITALIPID Adult is suitable for adults and children aged 11 years and older, whereas VITALIPID Pediatric is recommended for younger age groups.

2. What you need to know before using VITALIPID

Do not use VITALIPID

• if you are allergic to any of the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or nurse before using VITALIPID.
This medicine will be diluted before use and must not be mixed with other medicines or with other injectable products.
Prolonged administration of excessive doses of this medicine may lead to increased blood levels of vitamin D and its metabolites, which can cause a reduction in mineral levels in the bones (osteopenia).

Other medicines and VITALIPID
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Use this medicine with caution and inform your doctor if you are taking coumarin anticoagulant medicines, used to prevent blood clots, as there is a known interaction between vitamin K contained in VITALIPID and these medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before using this medicine.
This medicine may be used during pregnancy.

Driving and using machines
There are no data available to assess the effect of this medicine on the ability to drive vehicles and operate machinery.

VITALIPID contains soybean oil and egg phospholipids
VITALIPID contains soy. If you are allergic to peanuts or soy, do not use this medicine. Cross-allergic reactions between soy and peanuts have been observed (cross-allergies).
VITALIPID contains egg phospholipids, which may rarely cause allergic reactions.

VITALIPID contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.

3. How to use VITALIPID

This medicine will be administered to you by trained medical personnel. If you have any doubts, consult your doctor or nurse.

Use in adults and children aged 11 years and older
The recommended dose is 1 vial (10 ml) per day to be added to 500 ml of INTRALIPID.

Use in children under 11 years of age
In premature and low birth weight infants, up to 2.5 kg body weight, the recommended dose is 4 ml/kg body weight per day.
In children weighing more than 2.5 kg and up to 11 years of age, the recommended dose is 10 ml per day.

If you use more VITALIPID than you should
This medicine will be administered by trained personnel, so overdose is unlikely. However, if you think you have been given too high a dose of VITALIPID, inform your doctor or another healthcare professional immediately.
In case of overdose with this medicinal product due to prolonged infusion of excessive doses, increased blood levels of vitamin D and its metabolites may occur, which can lead to reduced mineral levels in the bones (osteopenia).

If you forget to use VITALIPID
This medicine will be administered by trained personnel, so it is unlikely that a dose will be missed.

If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
No side effects have been reported following the use of this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VITALIPID

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging to protect from light. Do not freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What VITALIPID contains
VITALIPID Adults

• The active substance is a mixture of vitamins. 1 ml of emulsion contains retinol palmitate equivalent to 99 mcg of retinol (330 IU), 0.5 mcg of ergocalciferol (20 IU), 0.91 mcg of dl-α-tocopherol (1 IU), 15 mcg of phytomenadione.
• The other components are refined soybean seed oil, purified egg yolk phospholipids, glycerol, sodium hydroxide, water for injections.

VITALIPID Children

• The active substance is a mixture of vitamins. 1 ml of emulsion contains retinol palmitate equivalent to 69 mcg of retinol (230 IU), 1.0 mcg of ergocalciferol (40 IU), 0.64 mcg of dl-α-tocopherol (0.7 IU), 20 mcg of phytomenadione.
• The other components are refined soybean seed oil, purified egg yolk phospholipids, glycerol, sodium hydroxide, water for injections.

Description of the appearance of VITALIPID and contents of the pack
VITALIPID Adults
Pack of 10 vials containing 10 ml each.
VITALIPID Children
Pack of 10 vials containing 10 ml each.
Marketing Authorization Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala (VR)
Italy
Responsible producer for batch release
Fresenius Kabi AB
Rapsgatan, 7
Uppsala
Sweden

The following information is intended exclusively for physicians or healthcare professionals

Therapeutic indications
VITALIPID is indicated during parenteral nutrition in patients requiring an exogenous supply of fat-soluble vitamins A, D, E, K.
In particular, VITALIPID Adult is suitable for adults and children aged 11 years and older, whereas VITALIPID Pediatric is recommended for younger patients.

Warnings and precautions
The product must be diluted before use. Compatibility with INTRALIPID 10% and 20% has been established.
VITALIPID must not be mixed with electrolyte solutions or any injectable drug, as there is a risk of emulsion destabilization.
Following prolonged infusion of excessive doses of vitamin D, elevated serum concentrations of vitamin D metabolites may occur, which can lead to osteopenia.

Dosage
Adults and children aged 11 years and older: 1 vial (10 ml) of VITALIPID Adult per day, added to 500 ml of INTRALIPID.
Children under 11 years of age:
4 ml/kg body weight per day of VITALIPID Pediatric for preterm infants and low birth weight infants up to 2.5 kg body weight; 10 ml per day for all children weighing more than 2.5 kg and up to 11 years of age.

Administration
Add VITALIPID aseptically to INTRALIPID 10% or 20%, no more than one hour before starting the infusion. Gently shake to promote mixing and administer within 24 hours, according to the established procedures for INTRALIPID.

For further information, please refer to the Summary of Product Characteristics.