Vitalipid N Infant/Vitalipid N Adult

Vitalipid N Infant/Vitalipid N Adult

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Vitamin A, vitamin D2, vitamin E, vitamin K1.
Description
A white, oil in water emulsion containing the fat-soluble vitamins A, D2, E and K1 in the oil phase of the emulsion with a composition corresponding to that of lntralipid 10%. pH approximately 8.
Vitalipid N Infant/Vitalipid N Adult is a sterile emulsion intended for addition to lntralipid.
Vitalipid N Infant: One ml contains retinol palmitate corresponding to retinol (Vitamin A) 69 µg (230 IU), calciferol (Vitamin D2) 1.0 µg (40 IU), all-rac-alpha­-tocopherol (Vitamin E) 0.64 mg (0.7 IU), phytomenadione (Vitamin K1) 20 µg, ol. sojae purif. 100 mg, lecithin. purif. e vitello ovi 12 mg, glycerol. anhydrous 22.0 mg, natr. hydroxid. q.s., aq. ad iniect. ad 1 ml.
Vitalipid N Adult: One ml contains retinol palmitate corresponding to retinol (Vitamin A) 99 µg (3300 IU), calciferol (Vitamin D2) 0.5 µg, all-rac-alpha­-tocopherol (Vitamin E) 9.1 mg (10 IU), phytomenadione (Vitamin K1) 15 µg, ol. sojae purif. 100 mg, lecithin. purif. e vitello ovi 12 mg, glycerol. anhydr. 22.0 mg, natr. hydroxid. q.s., aq. ad iniect. ad 1 ml.
The daily maintenance dosage of the vitamins A, D2, E and K1 are supplied during intravenous nutrition when 10 ml of Vitalipid N Adult are added to 500 ml lntralipid 10% or 20%.
Indications/Uses
Vitalipid N Infant: Vitalipid N Infant is indicated in infants and children up to 11 years of age as a supplement in complete intravenous nutrition to meet the daily requirements of the fat soluble vitamins A, D2, E and K1.
Vitalipid N Adult: Vitalipid N Adult is indicated as a supplement in complete intravenous nutrition to meet the daily requirements of the fat-soluble vitamins A, D2, E and K1.
Dosage/Direction for Use
Dosage: Must be diluted before use.
Vitalipid N Infant/Vitalipid N Adult should be added aseptically within one hour before the start of the infusion and should be used within 24 hours.
Vitalipid N Infant: Preterms and Infants below 2.5 kg: Vitalipid N Infant in a dosage of 4 ml/kg body weight/day.
Infants and children above 2.5 kg and under 11 years: Vitalipid N Infant in a dosage of 10 ml/day. The daily dosage must not exceed 10 ml. The daily dosage is added to lntralipid 10% or 20%. After mixing by gentle agitation the emulsion is infused as described for lntralipid. The daily maintenance dosages of the vitamins A, D2, E and K1 are thereby supplied.
Vitalipid N Adult: Adults and children age 11 years and above: One ampoule (10 ml) of Vitalipid N Adult is added to 500 ml lntralipid 10% or 20%. After mixing by gentle agitation the emulsion is infused as described for lntralipid. The daily maintenance dosage of the vitamins A, D2, E and K1 are thereby supplied.
Vitalipid N Adult can be used to reconstitute Soluvit N. The contents of one vial of Soluvit N (the daily maintenance dosages of water-soluble vitamins) are dissolved by the aseptic addition of 10 ml of Vitalipid N Adult and added to lntralipid.
Contraindications
Known hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients.
Special Precautions
This medicinal product contains soya-bean oil and egg phospholipids which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut.
Vitalipid N Infant/Vitalipid N Adult must not be given undiluted.
Drug Interactions
Vitalipid N Infant/Vitalipid N Adult contains vitamin K1 which may interact with anticoagulants of the coumarin type.
Caution For Usage
Further information: The manufacturer can be consulted for further information on complete and balanced intravenous nutrition regimens.
Storage
Store below 25°C. Do not freeze. Protect from light.
MIMS Class
Parenteral Nutritional Products
ATC Classification
B05XC - Vitamins ; Used in I.V. solutions.
Presentation/Packing
Form
Vitalipid N Adult inj
Packing/Price
10 mL x 10 × 1's
Form
Vitalipid N Infant inj
Packing/Price
10 mL x 10 × 1's
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