Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
retinol (retinol palmitate), phytomenadione, ergocalciferol, alfa-tocopherol
Fresenius Kabi AB
A11BA
retinol (retinol palmitate), phytomenadione, ergocalciferol, alfa-tocopherol
69mcg/ml+20mcg/ml+1mcg/ml+0,64mg/ml
emulsion for infusion
(10) ampoules 10ml blister
Prescription
Registered
2015-07-03
Title Date Page Summary of Product Characteristics 2008-09-16 1 (5) Product SmPC number Vitalipid N Infant SmPC 08-340 Compiled by Approved by Replaces SmPC number Evonne Strand Karin Heimdahl SmPC 05-279 EC 1. NAME OF THE MEDICINAL PRODUCT 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENTS PER ML Retinolpalmitate 135.3 µg . (corresponding to retinol) 69 µg Phytomenadione 20 µg Ergocalciferol 1.0 µg all-rac- α -Tocopherol 0.64 mg Corresponding to: Vitamin A 69 µg (230 IU) Vitamin D 2 1.0 µg (40 IU) Vitamin E 0.64 mg (0.7 IU) Vitamin K 1 20 µg pH: approx. 8 Osmolality: approx. 300 mosm/kg water For excipients, see section 6.1 3. PHARMACEUTICAL FORM Vitalipid N Infant is a sterile oil-in-water emulsion containing fat-soluble vitamins in the oil phase. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vitalipid N Infant is indicated in infants and children up to 11 years of age as a supplement in intravenous nutrition to meet the daily requirements of the fat-soluble vitamins A, D 2 , E and K 1 . Vitalipid N Infant, emulsion for infusion Emulsion for infusion. Product SmPC number Vitalipid N Infant SmPC 08-340 2 (5) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4 ml/kg bodyweight/day to preterm and low birth weight infants up to 2.5 kg bodyweigh, and 10 ml/day for all infants and children weighing more than 2.5 kg up to 11 years of age. See section 6.6. 4.3 CONTRAINDICATIONS Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 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. Vitaipid N Infant must not be given undiluted. 4.5 INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION The presence of trace elements may cause some degradation of vitamin A. Retinol (vitamin A) may be broken down by exposure to ultraviolet light. Vitamin K 1 interacts with anticoagu Прочитать полный документ