Država: Malta
Jezik: engleski
Izvor: Medicines Authority
PHYTOMENADIONE; DL-ALFA-TOCOPHERYL ACETATE; ERGOCALCIFEROL; RETINOL
Fresenius Kabi Limited
B05BA10
PHYTOMENADIONE; DL-ALFA-TOCOPHERYL ACETATE; ERGOCALCIFEROL; RETINOL
EMULSION FOR INFUSION
PHYTOMENADIONE 15 µg/ml; DL-ALFA-TOCOPHERYL ACETATE 0.91 mg/ml; ERGOCALCIFEROL 0.5 µg/ml; RETINOL 99 µg/ml
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2007-06-12
333 128 size: 210 x 148, 2:a kor r 09-09-11, Johanna Eriksson 2212112221 2212112221 333 128 P ACKAGE LEAFLET : INFORMA TION FOR THE USER VITLIPID ® N ADULT CONCENTR ATE FOR EMULSION FOR INFUSION Read all of this leafl et carefully before you start taking this medicine. • Keep this leafl et. Y ou may need to r ead it again. • If you have any further questions, ask your doctor or phar macist. • This medicine has been pr escribed for you. Do not pass it on to others. It may har m them, even if their symptoms ar e the same as yours. • If any of the side ef fects get serious, or if you notice any side ef fects not listed in this leafl et, please tell your doctor or phar macist. In this leafl et: 1. What is V itlipid ® N Adult and what it is used for 2. Befor e you r eceive V itlipid ® N Adult 3. How you ar e given V itlipid ® N Adult 4. Possible side ef fects 5. How V itlipid ® N Adult is stor ed 6. Further infor mation 1. WHA T IS VITLIPID ® N ADUL T AND WHA T IT IS USED FOR V itlipid ® N Adult pr ovides fat soluble vitamins when used together with Intralipid ® into your bloodstr eam when you cannot eat nor mally . It is usually used as part of a balanced intravenous diet, together with pr oteins, fat, carbohydrates, salts and other vitamins. 2. BEFORE YOU RECEIVE VITLIPID ® N ADUL T Y ou should not receive V itlipid ® N Adult: • if you ar e aller gic (hypersensitive) to V itlipid ® N Adult or any of the ingr edients of V itlipid ® N Adult mentioned in Section 6. If you develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), please inform your doctor . • if you have ever suf fer ed an aller gic r eaction to egg, soya or peanut pr otein • if it is undiluted . It will be added to another solution known as Intralipid ® befor e it is given to you. Y our doctor or nurse will make sur e it is pr epar ed cor rectly befor Pročitajte cijeli dokument
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vitlipid N Adult 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 10ml of Vitlipid N Adult contains: Retinol palmitate 990 micrograms corresponding to retinol (3,300 IU) Ergocalciferol 5 micrograms (200 IU) dl-alpha-tocopherol 9.1 mg (10 IU) Phytomenadione 150 micrograms 3. PHARMACEUTICAL FORM Concentrate for emulsion for infusion White oil in water emulsion for infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vitlipid N Adult is indicated for use as a supplement to Intralipid 10% or 20% for the intravenous nutrition of adults and children (over 11 years of age) in order to provide the daily requirements of the fat soluble vitamins A 1 , D 2 , E and K 1 . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Do not exceed the recommended dose. RECOMMENDED DOSAGE FOR ADULTS AND CHILDREN (OVER 11 YEARS OF AGE) One ampoule (10 ml) Vitlipid N Adult added to 500 ml Intralipid 10% or 20%. RECOMMENDED DOSAGE FOR THE ELDERLY No adjustment of the adult dosage is required. 4.3 CONTRAINDICATIONS Vitlipid N Infant should not be administered undiluted. Page 2 of 4 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. 4.5 INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION This preparation contains Vitamin K 1 , Pročitajte cijeli dokument