concentrate for infusion liquid, emulsion
all-ractocopherol, vitamin A, phytomenadione, ergocalciferol
What Vitalipid Adult is and what it is used for
Vitalipid Adult 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 Adult 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 Adult
Do not use Vitalipid Adult
- if you are allergic to the active substances or any other ingredients of this medicine (listed in section 6),
- if you are allergic to peanuts or soy. Vitalipid Adult contains soybean oil (purified soybean oil may contain peanut protein),
- if you are allergic to eggs,
- in high doses during pregnancy,
- if you are a child younger than 11 years old,
- if you have taken too many vitamins,
- if you have too much calcium in your blood or urine,
- if you are using vitamin A or medicines called retinoids (see “Other medicines and Vitalipid Adult” below).
Warnings and precautions
Tell your doctor immediately if you experience symptoms of allergy. See section 4 “Possible side effects” for more information.
Your doctor may want to check the amount of vitamin E in your blood, especially if you receive this medicine for long periods.
Talk to your doctor or nurse before receiving Vitalipid Adult if you:
- 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,
- is a child or of small stature,
- have a lot of calcium in the blood or urine,
- have a bleeding disorder,
- have a habit of drinking a lot of alcohol,
- 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 Adult
Tell your doctor if you are taking, have recently taken, or might take any 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 Adult and medicine with tipranavir contain vitamin E, which can lead to you taking in too much vitamin E.
- So-called anticoagulants (such as warfarin and phenprocoumon). Concomitant use of Vitalipid Adults with these drugs should be avoided because vitamin K can prevent their effect, and vitamin E can increase their effectiveness.
- 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 inactivate vitamin A.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Vitalipid Adult can be used during pregnancy. But high doses (over 8000 IU/day) of vitamin A should not be taken during pregnancy.
Vitalipid Adult can be used during breastfeeding.
Vitalipid Adult contains soybean oil
If you are allergic to peanuts or soy, do not use this medicine.
How to use Vitalipid Adult
The recommended dose for adults and children over 11 years of age is 10 ml (one ampoule ) per day.
Vitalipid Adult will be given to you by a doctor or nurse. Vitalipid Adult 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 you have been given too much Vitalipid Adult
Vitalipid Adult will be diluted and administered by healthcare professionals, so it is unlikely that you would receive a larger dose than you 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 Vitalipid Adult should be stored
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) | 910 micrograms | (1 IU) | 9100 micrograms | (10 IU) |
| Retinol palmitate equivalent retinal ( vitamin A) | 99 micrograms | (330 IU) | 990 micrograms | (3300 IU) |
| Phytomenadione ( Vitamin K 1 ) | 15 micrograms | 150 micrograms | ||
| Ergocalciferol ( Vitamin D 2 ) | 0.5 micrograms | (20 IU) | 5 micrograms | (200 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.