Medicinal Products

PEDIAVEN AP-HP NEW-NE OLIGO-ELEMENTS solution for infusion box of 10 bicompartmental bags of 250 ml

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Amino acids associated with carbohydrates and electrolytes
laboratory: Fresenius Kabi France

Injection solution for IV infusion
All forms

Indication

Parenteral nutrition of premature neonate and newborn with digestive intolerance, total or partial, prolonged.

Caloric intake of carbohydrate and nitrogen (amino acids of the L series). Electrolytic supply.

Dosage PEDIAVEN AP-HP NEW-NE OLIGO-ELEMENTS solution for infusion box of 10 bicompartmental bags of 250 ml

Parenteral nutrition of premature neonate and newborn with digestive intolerance, total or partial, prolonged.

Caloric intake of carbohydrate and nitrogen (amino acids of the L series). Electrolytic supply.

Against indications

· Renal insufficiency, apart from that related to neonatal physiological immaturity.

· Need for salt intake restriction.

Hypocalcemia with hyperphosphoremia.

· Congenital abnormality of amino acid metabolism.

· Severe and uncontrolled hyperglycemia.

· High and pathological plasma concentration of any of the electrolytes included in this product.

· Hypersensitivity to the active substances or to any of the excipients listed under Composition

· Unstable states (eg, severe post-traumatic conditions, decompensated diabetes mellitus, acute phase of circulatory shock, severe metabolic acidosis, severe sepsis and hyperosmolar coma).

In addition, general contraindications for infusion therapy should be considered, including: acute pulmonary edema, hyperhydration, untreated heart failure or hypotonic dehydration.

Adverse effects Pediaven Ap-hp Nn Oligo Ss

The following potential side effects may occur. Their frequency is indeterminate (can not be estimated from the available data):

Hepatobiliary disorders:

Transient disruption of liver function parameters;

Immune system disorders:

· Hypersensitivity reactions to certain amino acids;

Metabolism and nutrition disorders :

· Hyperphenylalaninemia may occur in preterm infants in a severe clinical condition;

· In case of excessive intake of amino acids, metabolic acidosis and hyperazotemia may occur especially in cases of renal and / or respiratory failure.

General disorders and administration site defects:

· In case of extravasation, inflammatory local reactions or necrosis may be observed.

The appearance of any abnormal sign should interrupt the infusion. In particular, the infusion should be stopped in case of chills, sweating, hyperthermia and dyspnoea.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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