Medicinal Products

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

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
Active Ingredients: Amino Acid Compartment 125ml: Alanine, Arginine, Aspartic Acid, Acetylcysteine, Glutamic Acid (E620), Glycine, Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Proline, Serine, Taurine, Threonine, Tryptophan, Tyrosine, Valin
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.
PAN> 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 bicompartment 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 water intake between 60 and 80 mL / kg / day,
PAN> - 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),
PAN> - an amino acid intake of about 1.5 g / kg / d, with a minimum of 0.9 g / kg / d.

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.
- The carbohydrate intake will be increased from 0.8 to 1.3 mg / kg / min (ie 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 / d). 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 to reach fairly quickly 3.5 g / kg / day of amino acids.

Due to the absence of potassium and 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 recommended intake of PEDIAVEN AP-HP NEW-NE 1 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):
PAN>

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.
Administration mode

In intravenous perfusion central or peripheral.
The administration must be continuous 24 hours.

Against indications

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

Adverse effects Pediaven AP-HP New-NE 1

Potential adverse effects may occur:
PAN> - hyperglycemia if the hourly flow rate of perfused glucose exceeds the patient's glucose utilization capacities (variables according to age and pathological situation);
- transient disturbance of the hepatic assessment;
PAN> - hyperphenylalaninemia in premature infants in a severe clinical condition;
hypersensitivity reactions to certain amino acids;
PAN> - thrombophlebitis, especially if 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.

In case of extravasation, local reactions such as inflammation or necrosis have been observed.
PAN>

The appearance of any uncontrolled abnormal signs (including chills, sweating, fever, difficulty breathing) should stop the infusion. Sepsis related to the catheter should be sought.

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