Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
CALCIUM PANTOTHENATE, CYANOCOBALAMIN, PANAX GINSENG, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN SODIUM, PHOSPHATE
Chiesi Espana S.A. c/Berlin 38-48. 7 Planta 08029. Barcelona, Spain
A13A
CALCIUM PANTOTHENATE 21.83 mg CYANOCOBALAMIN 0.01 mg PANAX GINSENG 150 mg NICOTINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE 3.03 mg THIAMINE HYDROCHLORIDE 2.24 mg RIBOFLAVIN SODIUM PHOSPHATE 2.73 mg
ORAL SOLUTION
CALCIUM PANTOTHENATE 21.83 mg CYANOCOBALAMIN 0.01 mg PANAX GINSENG 150 mg NICOTINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE 3.03 mg THIAMINE HYDROCHLORIDE 2.24 mg RIBOFLAVIN SODIUM PHOSPHATE 2.73 mg
POM
TONICS
Withdrawn
2006-11-03
ANVERSO: C/. Aranjuez, Nave 612 Polígono Industrial ALCALA I 28805 ALCALA DE HENARES (Madrid) Tels.: 91 882 42 86 91 882 45 73 Fax: 91 879 60 24 e-mail: diseno.zurita@telefonica.net COMPOSICIÓN CADA VIAL BEBIBLE CONTIENE: Extracto seco de Panax Ginseng C.A. Meyer del 30% (estandarizado y estabilizado, conteniendo 45 mg de ginsenósidos equivalentes a 1.500 mg de raiz) ..................................... 150 mg Piridoxina clorhidrato (Vitamina B 6 )................................................................................................................................................... 3,03 mg Nicotinamida (Vitamina PP) ............................................................................................................................................................... 20 mg Pantotenato de calcio ........................................................................................................................................................................ 21,83 mg Fructosa............................................................................................................................................................................................... 3.000 mg Etanol 96%.......................................................................................................................................................................................... 1,60 ml Y otros excipientes (Sacarina sódica, Parahidroxibenzoato de metilo sal de sodio, Edetato de disodio, Glicerol, Polisorbato 80, Esencia de aperitivo, Esencia de oporto, Esencia de borgoña, Esencia de jerez, Caramelo glucosa, Agua Agua purificada) c.s.p. ............................................................ 10 ml CADA TAPÓN CONTIENE: Tiamina clorhidrato (Vitamina B 1 )...................................................................................................................................................... 2,24 mg Cianocobalamina (Vitamina B 12 ).................................................... Prečítajte si celý dokument
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TON-WAS. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains dry _Panax ginseng CA Meyer 30% _(standardised and stabilised with a ginsenoside content of 45 mg equivalent to 1,500 mg of root) extract, 150 mg; pyridoxine (INN) hydrochloride (vitamin B 6 ), 3.03 mg; calcium pantothenate (INN), 21.83 mg; nicotinamide (INN) (vitamin PP), Each stopper contains thiamine (INN) hydrochloride (vitamin B 1 ), 2.24 mg; cyanocobalamin (INN) (vitamin B 12 ), 0.01 mg; riboflavin (INN) 5-sodium phosphate 2 H 2 O (vitamin B 2 ), 2.73 mg. List of excipients: see point 6.1. 3. PHARMACEUTICAL FORM Oral solution and powder for oral solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Prevention of group B vitamin deficits during convalescence and due to diet (vegetarian or weight loss). Due to the presence of ginseng, it is indicated in tiredness, psycho-physical exhaustion and lassitude. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The usual dose is 1 vial per day. It can be increased by the physician according to each patient's requirements and response. 4.3. CONTRAINDICATIONS It should not be administered to patients presenting allergy to any of its components, severe renal impairment and hypertension, Leber's disease, anxiety and irritability. 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Warning about excipients Page 2 of 8 This medicinal product (10 vials) contains 30 g of fructose. Each dose (1 vial) contains 3 g of fructose, which should be taken into consideration in patients presenting hereditary intolerance to this compound. In view of the possibility of this intolerance being as yet undiagnosed, do not administer to children without consulting a doctor. Since this medicinal product contains glycerol as an excipient, it could be harmful Prečítajte si celý dokument