TNA-Peri

TNA is a triple chamber bag in a vacuum sealed transparent over wrap. Also placed between the bag and over wrap are two 'Ageless' oxygen scavengers. The TNA bag is separated into three chambers by two peel seals.
Individual chambers consisting of Amino acid solution, Dextrose solution and MCT-LCT based parenteral fat emulsion respectively. (See Table 1).

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The contents of the three chambers have to be mixed before use, by opening of the peelable seals. (See Table 2).

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Pharmacology: Pharmacodynamics: As an intravenous nutrition fluid, TNA-Peri mixtures provide nutritional support to maintain the nitrogen-energy balance which may be altered by malnutrition and patient disease. TNA-Peri provides a bioavailable source of nitrogen (L-amino acids), energy (as glucose and lipids), essential fatty acids and electrolytes.
Pharmacokinetics: The amino acids, electrolytes, glucose and lipid in TNA-Peri are distributed, metabolized and excreted in an identical manner to the individual amino acids, glucose and electrolytes intravenous solutions and intravenous lipid emulsion, when they are individually co-infused in the patient.

Parenteral nutrition for adults where oral or enteral route for nutrition is not available, not possible, not sufficient or contraindicated.

The dose should be individualized and the choice of bag size should be made with regard to the patient's clinical condition, body weight and nutritional requirements. To provide total parenteral nutrition, trace elements and vitamins should be given additionally.
The nitrogen requirements for maintenance of body protein mass depend on the patients condition (e.g. nutritional state and degree of catabolic stress). The requirements are 0.10-0.15 g nitrogen/kg body weight/day in the normal nutritional state or in conditions with mild metabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.30 g nitrogen/kg body weight/day (1.0-2.0 g amino add/kg body weight/day). The corresponding commonly accepted requirements are 2.0-6.0 g for glucose and 1.0-2.0 g for fat.
Infusion Rate: The recommended rate of infusion is for TNA-Peri is 1 mL/min for initial 10-15 minutes. If no adverse reactions occur, the rest of the solution can be infused at the infusion rate of 2-3 mL/min. TNA-Peri can be infused either through a central or peripheral vein.
Infusion may be continued for as long as required by the patient's clinical condition. However, it is recommended that infusion period should be between 12-24 hours.

In case of incorrect administration (dosage and rate), signs of hypervolemia and acidosis may be observed. Hyperglycemia, glycosuria, and a hyperosmolar syndrome may occur with excessive glucose infusion. A too rapid infusion of amino acid may result in nausea, vomiting and shivering. In such cases, discontinue the infusion immediately.
In case of fat overdosing (an abnormal triglyceride rise under infusion of fat) causing special reactions (general symptoms such as fever or evocating an hemodynamic instability, emesis, algia, liver function abnormalities, hepato- or splenomegaly, hemostasis disorders, hyperlipidemia, hypersensitivity) fat infusion should be stopped or if necessary, continued at a reduced dosage.
In some serious cases, haemodialysis, haemofiltration or haemodiafiltration may be necessary.

Known hypersensitivity to egg or soy protein or to any of the ingredients; severe hyperlipaemia; severe liver insufficiency; severe blood coagulation disorders; in born errors of amino acid metabolism; severe renal insufficiency without access to hemofiltration or dialysis; acute shock; hyperglycemia, which requires more than 6 units insulin/h; pathologically elevated serum levels of any of the included electrolytes.
General contraindications to infusion therapy: Acute pulmonary hypertension, hyperhydration, decompensated cardiac insufficiency and hypotonic dehydration; hemophagocytic syndrome; unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma).

Do not use if separation of the fat emulsion is observed. As with all parenteral solutions, additives (vitamins, electrolytes, trace elements, drugs) may be incompatible. In case of supplementation, compatibility should be checked before administration to the patient. Additions should be performed under aseptic conditions after mixing the contents of the compartments. Additions can be made through the injection port with a needle: 1. Prepare injection port.
2. Puncture the port and inject.
3. Mix the admixture and the additives.
Administer the product only after breaking the seals and mixing the contents of the three compartments.
Do not exceed the recommended infusion rate.
Do not administer before or after administration of blood through the same infusion equipment.
Do not connect in series in order to avoid air embolism due to possible residual air contained in the primary bag.
Discard any unused mixture.
For single use only.
Do not store partly used containers and discard all equipment after use.

The ability to eliminate fat should be monitored. It is recommended that this is done by measuring serum triglycerides after a fat-free period of 5-6 hours. TNA-Peri are designed for adult patients. Due to composition, TNA-Peri is not suitable for the use in new-borns or infants under 2 years of age.
Disturbances of the electrolyte and fluid balance (e.g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion. Special clinical monitoring is required at the beginning of any intravenous infusion. If any abnormal sign occurs, the infusion must be stopped. Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.
TNA-Peri should be given with caution in conditions of impaired lipid metabolism, such as in renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia) and sepsis. If TNA-Peri is given to patients with these conditions, close monitoring of serum triglycerides is mandatory.
Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver enzyme tests (alkaline phosphatase, ALT, AST) should be monitored.
Blood cell count and coagulation should be monitored when fat is given for a longer period.
In patients with renal insufficiency, the phosphate and potassium intake should be carefully controlled to prevent hyperphosphatemia and hyperkalaemia. The amount of individual electrolytes to be added is governed by clinical condition of the patient and by frequent monitoring of serum levels.
Parenteral nutrition should be given with caution in metabolic acidosis, lactic acidosis, insufficient cellular oxygen supply and increased serum osmolarity.
TNA-Peri should be given with caution to patients with a tendency towards electrolyte retention. Any sign or symptom of anaphylactic reaction (such as fever, shivering, rashes and dyspnea) should lead to immediate interruption of the infusion.
The fat content of TNA-Peri may interfere with certain laboratory measurements (e.g. bilirubin, lactate dehydrogenase, oxygen saturation, Hb) if blood is sampled before fat has been adequately cleared from the bloodstream. Fat is cleared after a fat-free interval of 5-6 hours in most patients.
Intravenous infusion of amino acids is accompanied by increased urinary excretion of the trace elements, especially during long-term intravenous nutrition. In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure as well as a decrease in the serum concentration of potassium, phosphorus, magnesium and water-soluble vitamins. These changes can occur within 24 to 48 hours, therefore slow and careful initiation of parenteral nutrition is recommended together with close monitoring and appropriate adjustments of fluid, electrolytes, minerals and vitamins.
TNA-Peri should not be given simultaneously with blood in the same infusion set due to the risk of pseudo agglutination. In patients with hyperglycaemia, administration of exogenous insulin might be necessary.

No specific studies have been performed to assess the safety of TNA-Peri in pregnancy and lactation. The prescriber should consider the benefit/risk relationship before administering TNA-Peri to pregnant or breast feeding women.

The potential undesirable effects arise from inappropriate use e.g. too high dosage, too rapid infusion (see Warnings and Precautions).
Due to its lipid emulsion content, the administration of TNA-Peri may rarely lead to acute reactions such as hyperthermia, sweating, shivering, headache, dyspnoea. If so, the infusion must be discontinued. During long term parenteral nutrition (6 to 8 weeks or more), temporary increase of alkaline phosphatase, transaminase and bilirubin levels has been reported. These parameters usually return to normal once the dosage has been reduced. Some cases of hepatomegaly and icterus have been very rarely noted. In some rare cases thrombopenia has been reported in children. Thrombophlebitis may occur during peripheral nutrition.

Additives such as electrolytes, trace elements, vitamins and drugs may be prescribed. Some of these additives may be incompatible. If no information on the compatibility of the additives is available, refer a pharmacist or the manufacturer.
The solution should not be administered with, before or after an administration of blood through the same equipment because of the possibility of pseudo agglutination.

Instructions for Handling: 1. To Open: Tear the overwrap & dispose "Ageless" Oxygen Scavenger.
Check to ensure the integrity of the container and the peel seals.
Use only when the solutions are clear, homogenous & practically free from particles and the container is undamaged.
2. To Mix Solutions: Grasp the container with both the hands.
Squeeze or roll the container and the peel seals.
Mix by inverting the bag at least 3 times.
3. Preparation for Administration: Suspend the container.
Remove the protective cover from the administration port.
Firmly insert the spike of the administration set into the administration port.

Store at temperatures not exceeding 30°C. Store in over-wrap. Do not freeze.
Shelf Life: 18 months from the date of manufacturing.

Parenteral Nutritional Products

V06DE - Amino acids/carbohydrates/minerals/vitamins, combinations ; Used as general nutrients.

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