Celemin Infant (Amino acid) 100ml

CELEMIN Infant™ Amino Acids (10% W/V) Injection Suitable Combination of Amino Acids as per Infant Needs Motherly Nourishment for New Life Parenteral Amino Acids Help In: Weight gain and muscle mass Increase in length and head circumference Providing positive nitrogen balance Abbreviated Prescribing Information Composition Each 100 mL contains: L-Leucine USP – 1.300 g L-Isoleucine USP – 0.800 g L-Lysine Acetate USP – 1.200 g (equivalent to L-Lysine 0.851 g) L-Methionine USP – 0.312 g L-Phenylalanine USP – 0.375 g L-Threonine USP – 0.440 g L-Tryptophan USP – 0.201 g L-Valine USP – 0.900 g L-Arginine USP – 0.750 g L-Histidine USP – 0.476 g Glycine USP – 0.415 g Taurine USP – 0.040 g L-Serine USP – 0.767 g L-Alanine USP – 0.930 g L-Proline USP – 0.971 g N-Acetyl-L-Tyrosine BP – 0.5176 g (equivalent to L-Tyrosine 0.420 g) L-Malic Acid – 0.262 g N-Acetyl-L-Cysteine USP – 0.070 g (equivalent to L-Cysteine 0.052 g) Sodium Hydroxide BP – q.s. to adjust pH Water for Injections BP – q.s. Energy Content: 400 kcal/L (approx.) Total Nitrogen: 14.9 g/L Total Amino Acids: 100 g/L Osmolarity: 885 mOsmol/L E/N Ratio: 1.08 Fischer’s Ratio: 5.16 Indications Building blocks for protein synthesis in the parenteral nutrition of: Preterm newborns Term newborns Babies and young children up to 2 years of age Should generally be administered with energy-supplying infusion solutions. Dosage Maximum infusion rate: Up to 0.1 g amino acids/kg body weight/hour (1.0 mL/kg/hour). Maximum daily dosage: Preterm newborns: 2.5 g amino acids/kg/day = 25 mL/kg/day At 1 year: 1.5–2.5 g amino acids/kg/day = 15–25 mL/kg/day At 2 years: 1.5 g amino acids/kg/day = 15 mL/kg/day Method of Administration For central venous infusion in physiological metabolic conditions. CELEMIN Infant is one component of parenteral nutrition. For total parenteral nutrition, supplementation with energy carriers, electrolytes, vitamins, and trace elements is necessary. Contraindications Disturbances in amino acid metabolism Acidosis Hyperhydration Hypokalaemia Life-threatening unstable cardiovascular system (shock) Use individualized dosing in patients with renal or hepatic impairment. Precautions Monitor: Urea nitrogen Acid-base balance Serum ionogram Serum ammonia levels Liver enzymes Fluid balance Serum amino acid levels if necessary Rapid infusion may cause intolerance and amino acid imbalance. Adverse Reactions Rapid peripheral infusion may cause: Vein irritation Nausea Vomiting Shivering Renal loss of amino acids in patients with liver dysfunction Overdose May result in: Hyperhydration Metabolic acidosis Hyperosmolarity Electrolyte disturbances Hyperammonaemia If overdose symptoms occur, slow or discontinue the infusion. Presentation Available as Amino Acids (10% W/V) Injection in: 500 mL plastic bottles 500 mL glass bottles Storage Store below 30°C Protect from light Do not freeze Use with a non-pyrogenic IV administration set using aseptic technique Key Features of CELEMIN Infant™ 18 Amino Acids 52% Essential Amino Acids (EAA) 30% Branched-Chain Amino Acids (BCAA) 10 g amino acids and 1.49 g nitrogen per pack Contains conditionally essential amino acids: Tyrosine Cysteine Taurine Low content of: Methionine Phenylalanine pH Balance: 5.5–6.5 Amino acid formulation close to breast milk Dosage Summary Preterm newborns 2.5 g AA/kg body weight 25 mL/kg body weight At 1 year 1.5–2.5 g AA/kg body weight 15–25 mL/kg body weight At 2 years 1.5 g AA/kg body weight 15 mL/kg body weight