Medicinal Products

PEDIAVEN AP-HP NEW-1 Solution for infusion Box of 10 Pockets of 250 ml

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
Active Ingredients: Glucose, Alanine, Arginine, Aspartic Acid, Cysteine, Glutamic Acid (E620), Glycine, Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Proline, Serine, Taurine, Threonine, Tryptophan, Tyrosine, Valine, Gluconate calcium (E578), L
lab: HP Public Support

Injection solution for IV infusion
All forms

Indication

Basic support for parenteral nutrition of preterm or non-preterm infants when oral or enteral feeding is impossible, insufficient or contraindicated. PEDIAVEN AP-HP NEW-NE 1 is particularly intended for feeding the first 24 to 48 hours of life of the newborn whether premature or not.
Caloric intake of carbohydrate, nitrogen (amino acids of the L series). Contribution in electrolytes and trace elements.

Dosage PEDIAVEN AP-HP NEW-1 Solution for infusion Box of 10 Pockets of 250 ml

Dosage:
- The dosage is individual and varies according to age, weight, metabolic and energy needs, as well as the patient's clinical condition and metabolic abilities.
- During the first 24 hours of life, the first parenteral nutrition prescription will be made as soon as possible, and continuously, so as to obtain:
. a fluid intake between 60 and 80 ml / kg / day,
. a carbohydrate intake of approximately 6 mg / kg / min (ie 0.35 g / kg / h or 8 g / kg / day), between 4 and 8 mg / kg / min (ie 0.25 to 0.5 g / kg / h or 6 to 12 g / kg / day),
. an amino acid intake of about 1.5 g / kg / day, with a minimum of 0.9 g / kg / day.
Optimal amino acid intake can be ensured by adding the necessary amount of PEDIAVEN AP-HP NEW-3.
- After the first 24 hours of life:
. The fluid intake can be increased from 20 ml / kg / day to an intake of between 160 and 180 ml / kg / day. The increase in fluid intake will be adjusted to renal and transdermal losses.
. Carbohydrate intake will be increased from 0.8 to 1.3 mg / kg / min (0.05-0.08 g / kg / h or 1-2 g / kg / day) depending on the carbohydrate tolerance. at a maximum intake of 13 mg / kg / min (ie 0.75 g / kg / h or 18 g / kg / day). In case of cyclization of parenteral nutrition, a maximum hourly flow rate of 20 mg / kg / min (ie 1.2 g / kg / h) will not be exceeded .
. Nitrogen intake will be increased accordingly and adapted by adding the necessary amount of PEDIAVEN AP-HP NEW-NE 3 to reach fairly quickly 3.5 g / kg / day of amino acids.
- Due to the absence of sodium, potassium, phosphorus in its formula, PEDIAVEN AP-HP NEW-NE 1 is not indicated for parenteral nutrition beyond the first 48 hours of life, except in special situations .
- The maximum dosage of PEDIAVEN AP-HP NEW-NE 1 is limited by the contributions of the minerals which compose it, in particular by the contributions of calcium. As a result, the maximum intake of PEDIAVEN AP-HP NEW-NE 1 recommended is 160 ml / kg / day (providing 60 mg / kg / day of calcium). Beyond this dosage, monitoring of ionized calcium is strongly recommended .
Supplementation:
- This nutrient solution can be supplemented, on the express condition of having first checked the stability of the final mixture.
- In case of exclusive parenteral nutrition, vitamin supplementation is recommended from the first use, ie from the first hours of life.
- Addition of vitamins : stability has been shown for a mixture containing 250 ml of PEDIAVEN AP-HP
NEW-NE 1 with 10 ml of the vitamin solution having the following composition (note: the mixture obtained is yellow):
For 10 ml :
. Thiamine (B1): 2.5 mg.
. Riboflavin (B2): 3.6 mg.
. Nicotinamide (PP, B3): 40 mg.
. Ac. Pantothenic (B5): 15 mg.
. Pyridoxine (B6): 4 mg.
. Biotin (B8): 0.06 mg.
. Folic acid (B9): 0.4 mg.
. Cyanocobalamin (B12): 0.005 mg.
. Ascorbic acid (C): 100 mg.
After adding vitamins, protect the pocket of light.
- Addition of amino acids : it is possible to add directly to the pocket of PEDIAVEN AP-HP NEW-NE 1 an adequate volume of the solution PEDIAVEN AP-HP NEW-NE 3 (solution of amino acids and minerals) . Given the volume of the bag, the maximum volume added will be 25 ml.
Administration mode :
- In central or peripheral intravenous perfusion.
- Administration must be continuous 24 hours.

Against indications

- Known hypersensitivity to a component of the solution.
- Congenital abnormality of amino acid metabolism.

Adverse effects Pediaven AP-HP New-NE 1

- Potential adverse effects may occur:
. hyperglycemia if the hourly flow rate of glucose infused exceeds the patient's glucose utilization capacity (variables according to age and disease status);
. transient disruption of liver function;
. hyperphenylalaninemia in premature infants in a severe clinical condition;
. hypersensitivity reactions to certain amino acids;
. thrombophlebitis, especially if the perfusion is performed intravenously peripheral.
- In case of excessive intake of amino acids, metabolic acidosis and hyperazotemia may occur especially in cases of renal or respiratory failure.
- The appearance of any uncontrolled abnormal signs (including chills, sweating, fever, difficulty breathing) must stop the infusion. Sepsis related to the catheter should be sought.

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