Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
ERGOCALCIFEROL, ASCORBIC ACID, NICOTINAMIDE, THIAMINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, RETINOL PALMITATE, RIBOFLAVIN
Boston Healthcare Limited Unit 6, Navigation Court, Calder Park, Wakefield, West Yorkshire WF2 7JB, United Kingdom
A11JA
ERGOCALCIFEROL 400 U ASCORBIC ACID 50 mg NICOTINAMIDE 5 mg THIAMINE HYDROCHLORIDE 1 mg PYRIDOXINE HYDROCHLORIDE 500 µg RETINOL PALMITATE 5000 U RIBOFLAVIN 400 µg
ORAL DROPS, SOLUTION
ERGOCALCIFEROL 400 U ASCORBIC ACID 50 mg NICOTINAMIDE 5 mg THIAMINE HYDROCHLORIDE 1 mg PYRIDOXINE HYDROCHLORIDE 500 µg RETINOL PALMITATE 5000 U RIBOFLAVIN 400 µg
OTC
VITAMINS
Withdrawn
2006-04-19
PACKAGE LEAFLET: INFORMATION FOR THE USER DALIVIT DROPS (Vitamin A Palmitate, Vitamin D2, Vitamin B1, Vitamin B2, Vitamin B6, Vitamin C, Nicotinamide) READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available both with or without prescription. However, you still need to use Dalivit Drops carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What Dalivit Drops are and what they are used for 2. Before you take Dalivit Drops 3. How to give/use Dalivit Drops 4. Possible side effects 5. How to store Dalivit Drops 6. Further information 1. WHAT DALIVIT DROPS ARE AND WHAT THEY ARE USED FOR The name of this medicine is Dalivit Drops. Dalivit Drops are a multivitamin preparation and contain seven essential vitamins. The necessary vitamins are usually provided by a balanced diet, but if any of the essential vitamins are absent from food for long periods of time, poor growth or certain deficiency diseases can occur. This medicine helps prevent vitamin deficiencies and to maintain normal growth and health during the early years of infancy and childhood. Specific functions of active ingredients − • Vitamin A and Vitamin D2 are for the development of bones, teeth and skin and the prevention of rickets. • Vitamins B1, B2, B6 and Nicotinamide are for the development and functioning of the nervous system. Διαβάστε το πλήρες έγγραφο
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dalivit Drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.6 ml contains: Vitamin A Palmitate BP 5,000 units Ergocalciferol (Vitamin D 2 ) Ph Eur 400 units Thiamine hydrochloride BP 1 mg (Vitamin B1) Riboflavin (Vitamin B2) BP 400 micrograms Pyridoxine hydrochloride BP 500 micrograms (Vitamin B6) Ascorbic acid (Vitamin C) BP 50 mg Nicotinamide BP 5 mg _Excipient(s): _ This product contains Sucrose. This product also contains E219 Sodium Methylhydroxybenzoate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Drops, Emulsion (Oral Drops) Yellowish orange coloured liquid, slightly viscous. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a supplement for the prevention of vitamin deficiency states. As an aid to the maintenance of normal health and growth in infants and young children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration To be administered by oral route. _Dose: _ Infants from 6 weeks to one year : 0.3 ml daily (7 drops). Older children, adults and elderly: 0.6 ml daily (14 drops) or as directed by the physician. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the active substances or any of the excipients. Contra-indicated in hypercalcaemia. Contra-indicated in women who are (or may become) pregnant (see 4.6). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE When multivitamin preparations are prescribed allowance must be made for vitamins from other sources. No other preparations contain vitamin A should be taken with this preparation except under medical supervision. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Page 2 of 3 Label will state: Do Διαβάστε το πλήρες έγγραφο