2. PRESCRIPTION STATUS/RESTRICTION OF SALES TO PHARMACIES ONLY 3. COMPOSITION OF THE MEDICINAL PRODUCT ml of the solution for infusion contain:

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1 Title Page Information June (5) Aminoven infant 10% 1. NAME OF THE MEDICINAL PRODUCT Aminoven infant 10% 2. PRESCRIPTION STATUS/RESTRICTION OF SALES TO PHARMACIES ONLY For sale in pharmacies only 3. COMPOSITION OF THE MEDICINAL PRODUCT 3.1 Substance or indication group Solution for infusion 3.2 Active ingredients 1000 ml of the solution for infusion contain: L-leucine g L-isoleucine 8.00 g L-lysine monoacetate g = L-lysine 8.51 g L-methionine 3.12 g L-phenylalanine 3.75 g L-threonine 4.40 g L-tryptophan 2.01 g L-valine 9.00 g L-arginine 7.50 g L-histidine 4.76 g glycine 4.15 g taurine 0.40 g L-serine 7.67 g L-alanine 9.30 g L-proline 9.71 g N-acetyl-L-tyrosine g = L-tyrosine 4.20 g N-acetyl-L-cysteine 0.70 g = L-cysteine 0.52 g L-malic acid 2.62 g

2 Aminoven infant 10% June (5) 3.3 Other ingredients Water for injections Total amino acids 100 g/l Total nitrogen 14.9 g/l ph Titration acidity mmol NaOH/l Theoretical osmolarity 885 mosm/l 4. THERAPEUTIC INDICATIONS Building blocks for protein synthesis in the parenteral nutrition of preterm und term newborns, babies and young children up to 2 years of age. Amino acid solutions used for parenteral nutrition should be generally administered in an equivalent combination with energy supplying solutions for infusion. 5 CONTRAINDICATIONS Disturbances in the metabolism of amino acids, acidosis, hyperhydration, hypokalaemia, life-threatening unstable cardiovascular system (shock). Patients with insufficient renal or hepatic function require an individual dosage. Attention in case of hyponatraemia or elevated serum osmolarity. 6. UNDESIRABLE EFFECTS None known. 7. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS None known 8. WARNINGS None 9. MOST IMPORTANT INCOMPATIBILITIES Amino acid containing solutions should not be mixed with other medicinal products, except for parenteral nutrition products, due to the increased risk of microbiological contamination and incompatibilities.

3 Aminoven infant 10% June (5) When mixing with other nutrients such as electrolytes, vitamins or trace elements to Aminoven infant 10% for complete parenteral nutrition, care should be given to aseptic techniques, thorough mixing and, in particular, to compatibility. Under no circumstances Aminoven infant 10% should be stored after addition of other components. 10. POSOLOGY WITH SINGLE AND DAILY ADMINISTRATIONS Continuous intravenous drip infusion with respect to the needs of amino acids and fluid requirements. Unless otherwise prescribed, Maximum infusion rate: up to 0.1 g amino acids / kg body weight / hour = 1.0 ml / kg body weight / hour. Maximum daily dosage: Preterm newborns 2.5 g amino acids / kg body weight = 25 ml / kg body weight at the age of 1 year: g amino acids / kg body weight = ml / kg body weight at the age of 2 years: 1.5 g amino acids /kg body weight = 15 ml /kg body weight 11. METHOD AND DURATION OF ADMINISTRATION For central venous infusion in physiological metabolic condition. Aminoven infant 10% is merely one component of parenteral nutrition. For total parenteral nutrition a supplementation of energy carriers (with respect to the needs on essential fatty acids), electrolytes, vitamins, and trace elements is necessary. Aminoven infant 10% is administered as long as parenteral nutrition is required. 12. EMERGENCY MEASURES, SYMPTOMS AND ANTIDOTES A too rapid infusion via peripheral veins may lead to an irritation of the vein wall. Too rapid infusion may cause nausea, vomiting, shiver and a renal loss of amino acids in a patient with already existing pathological caused disturbed regulations in the liver with resulting limited liver functions.

4 Aminoven infant 10% June (5) As a consequence of not following the dosage recommendation hyperhydration, metabolic acidosis, hyperosmolarity, disturbances in the electrolyte status and hyperammonaemia may result in single cases. If symptoms of overdose occur, the infusion should be slowed down or discontinued until any signs of overdose disappeared. 13. PHARMACOLOGICAL AND TOXICOLOGICAL PROPERTIES, PHARMACOKINETICS AND BIOAVAILABILITY IN SO FAR AS THESE DETAILS ARE REQUIRED FOR THERAPEUTIC USE None 14. OTHER POINTS TO CONSIDER Frequent evaluation and determination of the following laboratory values are recommended for monitoring parenteral nutrition in preterm und term newborns, babies and young children up to 2 years of age: urea-nitrogen, acid-base balance, serum ionogram, serum ammonia level, liver enzymes, fluid balance and if necessary levels of the serum amino acids. During parenteral nutrition over a longer period of time thrombophlebitis may occur within the area of the punction side. Too rapid infusion may cause an intolerance phenomena and in consequence may lead to amino acid imbalances caused by renal losses. 15. SHELF-LIFE 2 years. 16. SPECIAL PRECAUTIONS FOR STORAGE Protect from light. If stored at low temperature crystals may be formed, which can easily be resolved by a slightly warming the solution. 17. PHARMACEUTICAL FORM AND PACK SIZES Infusion for solution Packs of: 10 x 100 ml 10 x 250 ml 6 x 1000 ml

5 Aminoven infant 10% June (5) 18. DATE OF INFORMATION Juni MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH Bad Homburg v.d.h. Germany This Information is valid and approved only for Germany. The Information applicable in your country may differ from this version. For detailed information valid and approved for your country, please refer to the local/national Fresenius Kabi affiliate.