Primen 10% Injection

Adult administration

The nitrogen requirement and amino acid metabolic capacity, considering the patient's weight, age, and clinical condition, should determine the dosage: for amino acids, 1.5 to 3.5 g per kg of body weight per day; for nitrogen, 0.23 to 0.53 g per kg of body weight per day; for this drug, 15 to 35 mL per kg of body weight per day. The infusion rate should not exceed 0.05 mL/kg/min, and the flow rate should be adjusted according to the daily protein dose, daily administered volume, and infusion duration.

Child administration

Newborns and infants are administered continuously for 24 hours. Children may receive continuous infusion for 24 hours or cyclical infusion for 8 to 12 hours a day. The infusion rate should not exceed 0.05 mL/kg/min.

This drug should be used with caution in patients with severely impaired heart, respiratory, or kidney function. In particular, children with reduced kidney function should control nitrogen intake. Patients with allergies to any of the amino acids, excipients, or container materials in this drug should not use it. During use, there may be hypersensitivity reactions such as facial or eyelid swelling and rashes, so caution is needed. Symptoms of increased ammonia levels in the blood have also been reported. During infusion, severe allergic reactions such as anaphylaxis may occur, so if such symptoms appear, infusion should be discontinued immediately. This drug poses a risk of precipitate formation in pulmonary vessels, so if pain is felt in the lungs, administration should be stopped immediately, and examinations should be performed. Regular checks should also be made for precipitates in the infusion set or catheter. Intravenous administration poses an infection risk, so special care should be taken for catheter management and aseptic handling. When resuming nutritional supply abruptly, symptoms such as electrolyte imbalance, fluid overload, and thiamine deficiency may occur, so administration should be gradual and closely monitored. Infusion of hypertonic solutions into peripheral veins can cause venous irritation or thrombosis, so caution is required. During administration, fluid and electrolyte balance, blood sugar, liver, and kidney function should be regularly monitored and observed carefully. Patients with impaired liver function may develop liver-related complications, so liver function values should be monitored frequently, and consultation with a specialist should be performed as needed. Patients with reduced kidney function may have decreased nitrogen excretion capabilities, so dose adjustment and fluid status management should be performed carefully. During administration, exposure to light should be avoided to prevent drug degradation, and extra caution should be taken with newborns and children under 2 years old. Thrombophlebitis, necrosis, or blistering may occur at the injection site, so the patient's condition should be monitored closely. Overdosing or infusing too rapidly can lead to serious side effects such as volume overload, electrolyte abnormality, acidosis, and azotemia, necessitating immediate discontinuation and appropriate treatment. Caution should be taken not to excessively add calcium and phosphate, as this may lead to precipitate formation. Before administration, confirm that the solution is clear and the container is not damaged, and any remainder after opening should be discarded immediately. Maintain a sterile state while mixing drugs and ensure no foreign substances are administered using infusion sets and filters. The safety of this drug for pregnant or breastfeeding women has not been established, so the benefits and risks should be carefully evaluated before use. The effect on driving or operating machinery is not known.

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, anaphylaxis/anaphylactoid reaction, severe allergic reaction, serious skin adverse reactions, symptoms related to liver abnormalities (jaundice), severe neurological symptoms, severe edema or urination abnormalities accompanied by elevated blood pressure

Mild side effects

Facial edema, eyelid edema, rash, fever, chills, hypotension, hypertension, arthralgia, myalgia, headache, increased bilirubin in the blood, increased liver enzymes, cholecystitis, cholelithiasis, metabolic acidosis, skin discoloration due to extravasation, thrombophlebitis at the injection site, venous irritation (erythema, warmth, swelling, induration at injection site), hyperammonemia, azotemia

This drug should be stored in a sealed container to prevent exposure to air or moisture, ideally at a temperature between 1 and 25 degrees Celsius. This storage helps maintain the drug's effectiveness and prevents deterioration.

Appearance

A colorless to pale yellow transparent solution in a colorless transparent glass vial, with a rubber stopper for infusion.

Package unit

100, 250ml/vial