concentrate for infusion liquid, emulsion
all-ractocopherol, vitamin A, phytomenadione, ergocalciferol
What Vitalipid Infant is and what it is used for
Vitalipid Infant is a sterile oil-in-water emulsion containing fat-soluble vitamins; all -rac – alpha-tocopherol ( vitamin E), vitamin A, phytomenadione ( vitamin K), and ergocalciferol ( vitamin D).
Vitalipid Infant is intended for patients receiving intravenous nutrition (as a drip into a vein) to meet the daily requirement of vitamins A, K, D, and E.
What you need to know before using Vitalipid Infant
Do not use Vitalipid Infant
- if your child is allergic to the active substances or any other ingredient of this medicine (listed in section 6),
- if your child is allergic to peanuts or soy. Vitalipid Infant contains soya oil (purified soya oil may contain peanut protein),
- if your child is allergic to eggs,
- if your child has received too much vitamin e,
- if your child has too much calcium in the blood or urine,
- if your child is using vitamin A or medicines called retinoids (see ‘Other medicines and Vitalipid Infant’ below).
Warnings and precautions
Tell your doctor immediately if your child develops symptoms of allergy. See section 4 “Possible side effects” for more information.
The doctor may want to check the amount of vitamin E in your child’s blood, especially if your child receives this medicine for long periods.
Before your child receives Vitalipid Infant, talk to your doctor or nurse if your child:
- have symptoms of skin and bone damage, such as scaling, itching, and yellowish color of the skin or joint and/or bone pain,
- have double vision,
- is on a low-protein diet,
- have kidney or liver problems,
- have a small body size,
- have a lot of calcium in the blood or urine,
- have a bleeding disorder,
- have bedsores, wounds, or burns,
- have difficulty absorbing nutrients from the gut due to short bowel syndrome,
- have cystic fibrosis,
- have heart problems.
Other medicines and Vitalipid Infant
Tell your doctor if your child is taking, has recently taken, or might be taking other medicines.
- Vitamin A and medicines called retinoids (eg bexarotene, used to treat a type of skin cancer). Concomitant use may increase the risk of side effects.
- Medicines containing tipranavir (used to treat HIV ). Both Vitalipid Infant and medicine with tipranavir contain vitamin E, which may lead to your child getting too much vitamin E.
- So-called anticoagulants (such as warfarin and phenprocoumon). Concomitant use of Vitalipid Infant with these medicines should be avoided as vitamin K may prevent their effect, and vitamin E may increase their effect.
- Vitamin supplements or medicines that contain vitamins. Interactions (collisions) between fat-soluble vitamins and other ingredients in medicinal products for intravenous nutrition are rare.
- Ultraviolet light can break down vitamin A.
Vitalipid Infant contains soya oil
If your child is allergic to peanuts or soya, do not use this medicine.
How to use Vitalipid Infant
The recommended dose for premature babies and babies with a low birth weight (body weight below 2.5 kg) is 4 ml/kg body weight/day.
The recommended dose for newborns and children weighing over 2.5 kg to children up to 11 years of age is 10 ml (one ampoule ) per day.
The total amount added to Vitalipid Infant must not exceed 10 ml/day.
Vitalipid Infant will be given to your child by a doctor or nurse. Vitalipid Infant is given as a drip into a vein ( intravenous infusion ) after dilution. Instructions for dilution can be found in the section intended for healthcare professionals.
If your child has been given too much Vitalipid Infant
Vitalipid Infant will be diluted and administered by healthcare professionals, so it is unlikely that your child would receive a larger dose than he or she should.
- A single overdose of fat-soluble vitamins should not cause side effects.
- Vitamin D: Long-term overdose with high doses can cause osteopenia (reduced bone density).
- Vitamin K: Rapid infusion of vitamin K can cause flushing, bronchospasm (constriction of the airways), tachycardia (palpitations), and low blood pressure.
- Vitamin A: A single overdose with high doses can cause gastrointestinal problems, headaches, increased pressure in the brain, swelling of the optic nerve, mental disturbances, irritability, convulsions or scaling of the skin, and skeletal changes (longer, shorter, or brittle bones). Long-term overdose can cause increased pressure in the brain, and changes in the bone structure that are usually recognized by soreness or painful swelling at the ends of the arms and legs.
If you have any further questions about this medicine, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
Has been reported (occurring in an unknown number of users)
- Allergic reactions. Symptoms may include rashes and hives; hard breathing; pressure on the chest, and swelling of the mouth, face, lips, or tongue.
How to store Vitalipid Infant
Store at a maximum of 25°C. Store in the original packaging. Light sensitive. Do not freeze.
For storage after dilution of the medicine, see the section intended for healthcare professionals.
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you notice that the solution is not a milky white emulsion or if the container is damaged.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are:
| 1 ml contains: | 10 ml contains: | |||
| all – rac -alpha-Tocopherol( Vitamin E) | 640 micrograms | (0.7 IU) | 6400 micrograms | (7 IU) |
| Retinol palmitate corresponding to retinol( Vitamin A) | 69 micrograms | (230 IU) | 690 micrograms | (2300 IU) |
| Phytomenadione ( Vitamin K 1 ) | 20 micrograms | 200 micrograms | ||
| Ergocalciferol ( Vitamin D 2 ) | 1 microgram | (40 IU) | 10 micrograms | (400 IU) |
- Other ingredients are purified soybean oil, purified egg phospholipids, glycerol, sodium hydroxide (for pH adjustment), and water for injections.
Appearance and package sizes of the medicine
Concentrate for infusion liquid, emulsion
Milk-like, white, sterile oil-in-water emulsion with pH approx. 8 and osmolality approx. 300 mOsm/kg water.