Vamin N (Amino Acids – Electrolytes)

VAMIN® N

Pharmacia & Upjohn

Amino Acids – Electrolytes

Nutritive and Electrolyte Supplements for I.V. Infusion

Action And Clinical Pharmacology: Vamin N supplies electrolytes and essential, semi-essential and nonessential L-amino acids for synthesis of body proteins. Nitrogen retention can be promoted by adjusting the energy to nitrogen ratio with simultaneous administration of lipids and/or hypertonic sugar solutions according to the needs of the patient. tag_IndicationsIndications

Indications And Clinical Uses: For parenteral nutrition in the following conditions: Pre- and postoperative nutritional disorders, in which an increased administration of amino acids is desired or necessary. In many cases this is synonymous with a disturbed nitrogen balance.

Nutritive disorders or nitrogen imbalance resulting from decreased or inhibited intestinal absorption. Such disorders may be due to tumors of the digestive tract, to acute or chronic intestinal diseases such as: peritonitis, ulcerative colitis or terminal ileitis.

Burns. In extensive burns the protein losses are often excessive. In these cases every amino acid and caloric supplement is of the utmost importance for reducing such losses.

Even if the patients are able to take nourishment by mouth, difficulties are often encountered in supplying sufficient amounts of protein and calories in the diet.

Prolonged states of unconsciousness, e.g., following trauma of the skull or intoxication and in such cases where tube feeding is inadvisable or impossible.

Cachexia due to serious diseases in organs other than the alimentary tract, e.g., metastasized tumors, systemic diseases.

As Vamin N does not contain sulfites, it can safely be used in patients with a known or suspected sulfite sensitivity.

Contra-Indications: Irreversible liver insufficiency and severe uremia when dialysis possibilities are lacking, and hypersensitivity to one or more amino acids are contraindications (see Warnings and Precautions).

Manufacturers’ Warnings In Clinical States: Clinical studies have shown that Vamin N is well tolerated both in the immediate postoperative period and in short-term i.v. nutrition. However, in isolated cases, nausea and hypersensitivity symptoms have been reported as was the possibility of liver malfunction.

Appropriate laboratory tests, especially those for the monitoring of liver functions and renal functions, should be performed periodically during the course of use of the product.

Infusion by central catheter should be used only by those familiar with this technique and its complications.

Compared to plasma, Vamin N is a hypertonic solution (665 mOsm/L). Consequently, when it is infused peripherally, care should be taken to select a vein such that blood flow is not reduced by the pressure of the needle or catheter. Furthermore, simultaneous infusion of isotonic nutrient solutions with a Y-connector should be employed to provide a dilution effect when using the peripheral technique.

Administration of Vamin N simultaneously with blood through the same infusion apparatus can provoke pseudoagglutination.

Pregnancy and Lactation and Children: Safety to the fetus and the neonate has not been established. Vamin N should be administered with caution to neonates and to females during pregnancy and lactation and only when this is deemed essential to the patient’s welfare, as judged by the physician.

Vamin N should be given with caution to very sick children, small and/or premature babies requiring neonatal intensive care due to the risk of inducing hyperphenylalaninemia. In such babies, it is advisable to monitor the plasma phenylalanine concentration.

Vamin N contains electrolytes including sodium ion and potassium ion. These electrolytes should be used with great care and with periodical monitoring using the appropriate laboratory tests.

Precautions: Vamin N should be used cautiously in severe hepatic diseases and acute renal impairment.

Vamin N should be given with caution to very sick children, small and/or premature babies requiring neonatal intensive care due to the risk of inducing hyperphenylalaninemia. In such babies, it is advisable to monitor the plasma phenylalanine concentration (see Warnings and Adverse Effects).

Infusion by central venous catheter should be used only by those familiar with this technique and its complications.

Adverse Reactions: Nausea: If such symptoms appear or are of a severe degree, reduce or discontinue the infusion.

Hypersensitivity: Rarely, patients may exhibit hypersensitivity to 1 or more amino acids.

Symptoms of thrombophlebitis can appear at the site of a peripheral vein infusion. In such instances, the infusion site should be changed to another vein. Use of a larger peripheral vein and reducing the rate of infusion might be helpful. Alternatively, infusion by central venous catheter can be used (see Precautions).

Dosage And Administration: The dosage of parenteral nutrient solutions should be calculated separately for each patient in accordance with nutrient requirements and body weight.

Vamin N provides 70 g crystalline amino acids/L. The basal requirements of amino acids for adults (0.7 to 1 g/kg body weight/day) can be met with 10 to 15 mL/kg of Vamin/day (or 1 L/day for a 70 kg patient).

The basal energy requirement of 20 to 30 kcal/kg/day should be met by infusing additional carbohydrate solution and/or lipid emulsion. The actual amount of additional carbohydrate and/or lipid to be included in the dosage should be adjusted to meet individual patient requirements.

The basal dosage of Vamin N (10 to 15 mL/kg/day) should be adjusted to meet increased amino acid and caloric requirements such as with severely depleted or hypercatabolic patients.

An infusion rate of between 4 and 2 mL/min is usually most suitable, such that 1 L of solution is infused during 4 to 8 hours in adults. Higher or lower infusion rates may be desirable for practical reasons.

When Vamin N is infused simultaneously with other nutrient solutions using a Y-connector either peripherally or centrally, the drip rates of each solution should be reduced in keeping with the patient’s tolerance for the total fluid volumes.

Infusion by central venous catheter should be used only by those familiar with this technique and its complications.

Symptoms of thrombophlebitis can appear at the site of peripheral vein infusion. In such instances, the infusion site should be changed to another vein. Use of a larger peripheral vein and reducing the rate of infusion may be helpful. Alternatively, infusion by central venous catheter can be used (see Warnings and Precautions).

Availability And Storage: Each 100 mL of sterile, pyrogen-free solution contains: Sulfite- and tartrazine-free. Bottles of 500 and 1 000 mL. Vamin N will remain stable for 2 years, when stored at 5 to 25°C.

VAMIN® N Pharmacia & Upjohn Amino Acids – Electrolytes Nutritive and Electrolyte Supplements for I.V. Infusion

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