Celemin Nephro

Celemin Nephro

Manufacturer:

Otsuka (Philippines)

Distributor:

Macropharma Corp
Full Prescribing Info
Contents
Amino acids.
Description
Each 100 mL of the IV inj contains the following: Essential Amino Acids: L-isoleucine 0.510 g, L-leucine 1.030 g, L-lysinemonoacetate (equivalent to L-lysine) 0.710 g, L-methionine 0.280 g, L-phenylalanine 0.380 g, L-threonine 0.480 g, L-tryptophan 0.190 g and L-valine 0.620 g.
Semi-Essential Amino Acids: L-arginine 0.490 g and L-histidine 0.430 g.
Non-Essential Amino Acids: Glycine 0.320 g, L-alanine 0.630 g, L-proline 0.430 g, L-serine 0.450 g, acetylcysteine (equivalent to L-cysteine) 0.037 g, L-malic acid 0.138 g, water for inj. Total amino acids: 70 g/L, total nitrogen content: 10.80 g/L. Energy content: 287 kCal/L. Osmolarity (theoretical): 635 mOsmol/L.
Celemin Nephro is a clear, colorless inj, containing well-balanced mixture of pure crystalline, essential, semi-essential and non-essential amino acids, which are in optimum concentration for protein synthesis.
Indications/Uses
Parenteral nutrition supplement in the following conditions: Acute and chronic renal insufficiency, in hemofiltration, peritoneal and hemodialysis; compensation of amino acid losses during and after dialysis or hemofiltration; renal failure following polytrauma, extensive surgery and sepsis; supplementing a low protein diet in chronic renal failure patients.
Dosage/Direction for Use
Recommended Daily Dosage: Up to 0.5 g of amino acids/kg body weight/day in acute and chronic renal insufficient patient not treated by dialysis. Up to 1 g of amino acids/kg body weight/day in patient treated by hemodialysis, hemofiltration or peritoneal dialysis.
Dosage should be adjusted according to amino acid requirements depending upon age, body weight and condition of patients. Adequate calories should be administered simultaneously either orally or parenterally. The infusion could be given either by peripheral or central route by suitably adjusting the flow rate.
Celemin Nephro is available as a sterile, non-pyrogenic, single-dose container that can be administered through peripheral veins or by central venous route using non-pyrogenic IV administration set with aseptic technique.
Contraindications
Disturbances of the amino acid metabolism; hepatic coma; serious renal disturbances, hypernatremia and hyperkalemia; congestive cardiac failure; hyperhydration; metabolic acidosis.
Special Precautions
Signs of intolerance and increased renal losses accompanied by amino acid imbalance may develop if the soln is infused too rapidly.
The fluid balance, serum electrolytes, blood sugar levels and acid base balance must be monitored.
For long-term therapy, fat should be included in the dietary regimen in order to avoid essential fatty acid deficiency.
The solution is unsuitable for long-term parenteral use as it does not contain adequate non-essential amino acids.
Adverse Reactions
Occasional chest discomfort and palpitation. Nausea, vomiting, chill and fever may occur if the recommended rate of infusion is exceeded.
Storage
Store below 25°C. Protect from light. Do not freeze.
ATC Classification
B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.
Presentation/Packing
Inj 7% w/v x 500 mL.
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