MG TNA-Peri

Each 100 mL admixture solutions contains: Fluid A: Glucose 11% 61.5 mL, Glucose monohydrate 7.44 g.
Fluid B: Amino acids 11.3% 20.8 mL, L-alanine 0.33 g, L-arginine 0.24 g, L-aspartic acid 0.071 g, L-glutamic acid 0.12 g, Glycine 0.16 g, L-histidine 0.14 g, L-isoleucine 0.12 g, L-leucine 0.16 g, L-lysine HCl 0.24 g, L-methionine 0.12 g, L-phenylalanine 0.16 g, L-proline 0.14 g, L-serine 0.094 g, L-threonine 0.12 g, L-tryptophan 0.04 g, L-tyrosine 0.005 g, L-valine 0.15 g, Calcium chloride hydrate 0.02 g, Sodium glycerophosphate hydrate 0.10g, Magnesium sulfate hydrate 0.07 g, Potassium chloride 0.12 g, Sodium acetate hydrate 0.17 g.
Fluid C: Fat emulsion 20% 17.7 mL, Purified soybean oil 3.54 g, Purified Yolk Phospholipid 0.21 g, Glycerol 0.39 g.
Total Cal.: 360 mL: 250 kcal; 480 mL: 350 kcal; 960 mL: 700 kcal; 1.440 L: 1000 kcal; 1.920 L: 1400 kcal.
Fat Emulsion+Amino Acids with Electrolytes+Glucose (MG TNA-Peri) is composed of plastic fluid bag partitioned into 3-chambers and an overpouch. An oxygen absorber is placed between the inner bag and the overpouch. Each chamber of the inner bag contains glucose solution, amino acid solution with electrolytes, and fat emulsion respectively. Glucose solution and amino acid solution with electrolytes are transparent and colorless or slightly yellow. Fat emulsion is white and homogenous.

Supply of water, electrolytes, amino acid and calories to the patients by parenteral nutrition when oral or enteral nutrition is unfeasible, insufficient or contraindicated.

Adult: The ability to eliminate fat and metabolize glucose should determine the infusion rate, and the dose should be determined individually and the choice of bag size should be made with regard to the clinical condition of the patient, the body weight and the nutritional requirements.
For patients in the normal nutritional state or under mild catabolic stresses, 0.7~1.0 g/kg (0.10~0.15 g of nitrogen/kg) daily of amino acids are administered by drip infusion. And, for patients under moderate to high catabolic stresses, 1.0~2.0 g/kg (0.15~0.30 g of nitrogen/kg) are administrated by drip infusion. Generally, 0.7~1.0 g/kg daily of total amino acids (0.10~0.15 g of nitrogen/kg) are administered by drip infusion into peripheral or central veins, which corresponds to 27~40 mL/kg of Fat Emulsion+Amino Acids with Electrolytes+Glucose (MG TNA-Peri).
Children: The ability to metabolise individual nutrients must determine the dosage. In general the infusion for small children (2-10 years) should start with a low dose i.e. 14-28 ml/kg (corresponding to 0.49-0.98 g fat/kg/day, 0.34-0.67 g amino acids/kg/day and 0.95-1.9 g glucose/kg/day) and increased by 10-15 ml/kg/day up to a maximum dosage of 40 ml/kg/day. For children over 10 years of age the dosage for adults can be applied.
The use of MG TNA-Peri is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential.
Administration rate : The maximum administration rate for glucose is 0.25 g/kg/h. Amino acid dosage should not exceed 0.1 g/kg/h.
Fat dosage should not provide more than 0.15 g/kg/h.The administration rate should not exceed 3.7 mL/kg/hr (equivalent to 0.25 g/kg of glucose, 0.09 g/kg of amino acids, 0.13 g/kg of lipid, respectively), and the recommended infusion period is 12-24 hours or as prescribed by the physician.

Overdose may cause nausea, vomiting, sweating, fluid overload, electrolyte imbalance, hyperglycemia, hyperosmolarity. In these cases, infusion should be slowed down or discontinued. In some rare severe cases, hemodialysis, hemofiltration or hemo-diafiltration may required.

Hypersensitivity to eggs, soy protein, or to any of the ingredients.
Hyperlipidemia.
Severe liver insufficiency.
Severe blood coagulation disorders.
Congenital disorder of amino acid metabolism.
Severe renal insufficiency without any access to hemofiltration or dialysis.
Acute shock.
Hyperglycemia requiring over 6 units hourly of insulin.
Pathologically elevated serum levels of the included electrolytes.
General contraindications of infusion therapy: acute pulmonary edema, hyperhydration, decompensated heart failure, hypotonic dehydration.
Hemophagocytotic syndrome.
Unstable conditions (e.g. severe post-traumatic conditions, decompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma).
Neonates or infants under 2 years of age.
Hypokalemia.
Myocardial infarction or patients with history of myocardial infarction.

The use of Fat Emulsion+Amino Acids with Electrolytes+Glucose (MG TNA-Peri) must follow the directions of doctor.
Any signs or symptoms of anaphylactic reaction (such as fever, shivering, rash, or dyspnea) should lead to immediate interruption of the infusion.

Carefully administer to the following patients: Patients with disorders of lipid metabolism induced by renal failure, pancreatitis, impaired liver function, hypothyroidism (accompanied by hypertriglyceridemia), sepsis, etc.
Lactic acidosis, insufficient cellular oxygen supply, increased serum osmolarity, patients who need a fluid resuscitation.
Patients with a tendency toward electrolyte retention.
General cautions: Special clinical monitoring is required at the beginning of intravenous infusion. Should any abnormal sign occur, the infusion must be stopped.
Prior to initial administration, the state of electrolyte imbalance (e.g. extraordinarily high or low concentration of serum electrolytes) of the patients must be corrected in advance.
As central venous injection increases the risk of infection, strict aseptic procedures should be taken during the insertion and manipulation of catheters to avoid any contamination.
The serum triglyceride level should not exceed 2 mmol/l in 5~6 hours after the administration.
As intravenous administration of amino acids accompanies the increased urinary excretion of trace elements such as copper or zinc, additional administration of these trace elements should be taken into consideration in case of long-term administration.
As there is a chance of false coagulation reaction, should not be injected with same syringes containing blood at the same time.
During the administration, serum glucose level, electrolytes, osmolarity, fluid balance, acid-base status, liver enzyme level (alkaline phosphatase, ALT, AST) etc. should be carefully monitored.
Blood cell count and coagulation should be monitored during long term administration.
In case of the administration to patients with renal failure, the intake of phosphate and potassium should be carefully controlled in order to prevent hyperphosphatemia or hyperkalemia.
The amount of additional electrolytes should be determined by frequent monitoring of the condition of patients and the serum electrolyte concentration.
In case of initial intravenous administration to the patients under malnutrition state, careful monitoring of the patients and fine-tuning of the amount of additional solutions, electrolytes, vitamins, minerals are required.
Influence on laboratory measurements: As the lipid ingredients may interfere with certain laboratory measurements (such as bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin, etc.) when the blood is collected prior to the entire elimination of lipid from the blood, it's better to collect the blood in 5-6 hours after administration.
Use in Elderly: As aged people generally shows reduced physiological activities, should be administered more slowly or reduced dose.

As no specific studies have been performed to assess the safety of Fat Emulsion+Amino Acids with Electrolytes+Glucose (MG TNA-Peri) in pregnancy and lactation, administration should be decided by the benefit-to-risk relationship.

Fat Emulsion+Amino Acids with Electrolytes+Glucose (MG TNA-Peri) may sometimes raise the body temperature (below 3% of incidence rate), or induce shivering, chillness, nausea/vomiting (below 1% of incidence rate).
It was reported to increase the activities of liver enzymes.
Thrombophlebitis may occur if peripheral vein are used.
It was stated to induce hypersensitive reactions (such as anaphylactic reaction, rash, urticaria), respiratory symptoms (hyperventilation), hyper/hypotension, etc. in very rare cases.
It was reported to induce hemolysis, increase reticulocytes, abdominal pain, headache, fatigue, penile stiffness.
The excessive administration may lead to fat overload syndrome characterized by following symptoms: hyperlipidemia, fever, fatty infiltration, hepatomegaly, megalosplenia, anemia, leukocytopenia, thrombocytopenia, blood agglutination disorder, coma, etc.

Though no clinically significant interaction is reported yet, there are some reports of following phenomena: Co-administered insulin may interfere with lipase system.
Heparin given in clinical doses causes a transient release of lipoprotein lipase into the circulation, which may increase the plasma lipolysis accompanied by transient decrease of triglyceride clearance rate at initial administration.
As vitamin K₁ included in soybean oil may interfere with the therapeutic effect of coumarin derivatives, close monitoring is recommended for patients treated with such drugs.
Glucose in solution may make a precipitation when mix with the acidic solution.

Do not use if package is damaged.
Do not use when the partition seals between chambers are broken.
Use only if glucose solution and amino acid solution with electrolytes are transparent, and fat emulsion is homogeneous.
Mix the contents of each chamber right before use.
Discard any remaining mixture after administration.
Direction for Use: 1. Tear off the plastic overpouch from the perforation and then pull out the parenteral bag.
2. Place the inner bag on a flat surface. The white compartment FLUID C (Fat Emulsion) should be on the bottom right and the infusion port on the top.
3-1. Break the partition seal by pressing the compartment of Fluid B (amino acids) with both palms, and then do the same with the seal of Fluid C.
3-2. Or, from the state of 2, break the partition seals by rolling with pressing the bag from the hanger hole with hands. Roll while all seals are broken.
4. Mix well by shaking the bag 2-3 times.
5. In case additives are needed to be mixed, remove the additive port cap to introduce the additives and shake the bag so that TNA mixture and additive are mixed well.
6. Connect the infusion set to the infusion port, and then administer into peripheral vein or central vein.

Store at temperatures not exceeding 30°C. (Do not refrigerate.)
Shelf Life: 2 years in the overpouch.

Parenteral Nutritional Products

B05BA - Solutions for parenteral nutrition ; Used in I.V. solutions.

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