SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 SUMMARY OF PRODUCT CHARACTERISTICS 1.- NAME OF THE PRODUCT AMICEN S SOLUCION 2.- QUANTITATIVE AND QUALITATIVE COMPOSITION COMPOSITION PER ML: Protein hydrolized from vegetal origin mg Sodium chloride... 9 mg Additives: Vitamins, pro-vitamins and chemically well-defined substances having similar effects: Vitamin A (3a672a) IU Vitamin D/Vitamin D 3 (E-671) IU Vitamin E(3a700)... 4 mg Vitamin B 1 (3a820)... 3 mg Vitamin B 2 /Riboflavin... 4 mg Vitamin B 6 /Pyridoxine hydrochloride (3a831)... 2 mg Vitamin B 12 /Cyanocobalamin µg Niacin (3a314) mg D-Calcium pantothenate (3a841)... 5 mg Ascorbic acid (3a300) mg Vitamin K 3 (3a710)... 2 mg Folic acid (3a316)... 1 mg Amino acids, their salts and analogues: Lysine/Lysine hydrochloride, tecnically pure (3.2.3.) mg L-arginine (3c3.6.1)... 5 mg DL-methionine, technically pure (3c301) mg L-glycine mg Water and other excipients n.q.

2 3.- PHARMACEUTICAL FORM Complementary feed for animal feeding 4.- PHARMACOLOGICAL PROPERTIES VITAMINS Vitamin A: Vitamin A is important in visual processes and cell maintenance and differentiation. Vitamin A is also known as the anti-infective vitamin as it protects the tissues of the epithelial cells of the respiratory, alimentary and genito-urinary tracts enabling them to maintain their ability to secrete mucus and thus their resistance to infection. Vitamin D 3 : Vit. D is very important for calcium uptake and regulation. Vitamin D is required for the normal calcification of the growing bone and promotes the calcification of the eggshells of birds as well as maintaining blood plasma calcium and phosphorus levels and aiding calcium absorption from the intestine. Vitamin E: Vitamin E plays a significant role in the reduction of free radicals which can damage cell membranes and other lipid-containing structures. Vitamin E plays a vital role in all the body cells and in the fertility of most animal species. Vitamin E maintains normal muscle metabolism and ensures good functioning of the central nervous system and vascular system. Vitamin B 1 : Vitamin B1, is also known as the antineuritic factor because of its physiological function in nerve activity. A good digestive system and the carbohydrate metabolism depend greatly on sufficient vitamin B1. Vitamin B 2 : Vitamin B 2 plays a central role in the release of energy from food. It helps in maintaining normal appetite, good digestion, healthy skin and good nerve functioning. Vitamin B 6 : Vitamin B6 helps build proteins and is essential to carbohydrate metabolism. It is needed for the biosynthesis of unsaturated fatty acids, and a deficiency can result in a loss of weight. Vitamin B 12 : Vitamin B 12 has a decisive influence on all the metabolic processes and as it helps build proteins, too, diets poor in protein or fatty diets can still give full nutritive value if a vitamin supplement containing this vitamin is added. Vitamin B 12 is used to treat pernicious and other forms of anaemia.

3 Niacin: A niacin deficiency is characterised by dermatitis, loss of weight, retarded, diarrhoea and disorders of the central nervous system. D-Calcium pantothenate: pantothenic acid is a component of only one coenzyme, coenzyme A, which is required for the synthesis of fats and conversion of carbohydrates. A pantothenic acid deficiency leads to skin and hair lesions, gastro-intestinal troubles, retards the development of feathers and embryos and causes dermatitis in the area of the eyes, mouth, vent and feet in chicks. Ascorbic acid: Vitamin C helps form and maintain the "cementing" materials that hold body cells together and strengthen the walls of blood vessels, and it aids in healing wounds. Ascorbic acid participates in the synthesis of certain hormones and in cellular respiration. Vitamin K3: It is an antihemorrhagic since it produces protrombine in blood. The vitamin K3 synthesis in the birds is not very considerable and it is necessary to make sure that the quantity taken is sufficient. Folic acid: As well as helping to build proteins and the cell nucleus, folic acid acts as an enzyme in the digestive system thus aiding intestinal absorption. Like vitamin C and vitamin B12, folic acid plays an important role in preventing anaemia and in building anti-bodies. AMINO ACIDS Amino acids: Amino acid balance is known as protein "quality" and the requirement is depending on the animal species and on the life stage. Also other factors, like the health status, may affect the requirements. Amino acids which are essential cannot be synthesized by the animal and therefore must be provided by the diet. Therefore the goal is to know the exact requirement of the animal for every essential amino acid in order to supply this amount to the animal via the diet. Lysine: is a key amino acid that animals need to optimize their genetic potential. Methionine: is an essential amino acid in all animal species. Supplementation of appropriate amounts of methionine to meet requirements is safe for the target species. Methionine is clearly recognised as the first limiting amino acid in poultry, and probably also in high-yielding cows, and as the second or third limiting amino acid in pigs fed conventional diets.

4 Methionine has at least foru main roles; first, participates in protein synthesis. Second, Methionine is a glutathione precursor, a tripeptide that reduces reactive oxygen species and thus protects cells from oxidative stress. Third, methionine is required for the synthesis of polyamines (spermine and spermidine), which take part in nucleus and cell division events. Fourth, methionine is the most important methyl group donor for methylation reactions of DNA and other molecules. Several studies demonstrated that methionine constructively affects the immune system, improving both cellular and humoral immune response. L-arginine and L-glycine: are non essential amino acids. Glycine is a major constituent of extracellular structural proteins (collagen and elastin) in animals. Arginine is essential to birds. In addition of being required to optimal growth, arginine is also important for a series of biological and physiological functions, including protein biosynthesis, nitrogen transport and excretion, production of polyamides and nitric oxide, and stimulation of several endocrine glands. Due to the lack of some enzymes in the urea cycle, broiler chickens are unable to biosynthesize arginine from ornithine; thus, this amino acid must be supplied in diets. It was recently demonstrated that L-arginine increases specific immune response against Infectious Bursal Disease in chickens. 5.- CLINICAL DATA 5.1. Target species of animals Poultry, fattening pigs, fattening bovine, calves, fattening lambs and rabbits Therapeutic indications, specific for the target species Animal nutrition supplement. Vitamins and amino acids Contraindications 5.4. Adverse effects

5 5.5. Special precautions for use Not necessary Use during pregnancy and lactation 5.7. Drug interactions 5.8. Doses Administer the following dosages: Poultry, fattening bovine, milking calves, fattening pigs, fattening lambs, fattening rabbits: 1 ml / 1L of drinking water Special advice for target species Withdrawal time Not necessary Special precaution to be taken by the person administering the drug to animals Not necessary. 6. PHARMACEUTICAL DATA 6.1. Incompatibilities

6 6.2. Shelf life 2 years from manufacturing date Special maintenance measures Store in a fresh and dry place, protected from light Specifications about the packaging Bottles containing 1 L or 5 L made of high-density polyethylene Special precautions for the disposal of unused medicinal product or waste materials, if any Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 7. NAME OR CORPORATE NAME AND ADDRESS OR REGISTERED PLACE OF BUSINESS OF THE MARKETING AUTHORISATION HOLDER CENAVISA, S.L. Camí Pedra Estela, s/n Tel: Fax: REUS / SPAIN