Medicinal Products

PEDIAVEN AP-HP G20 solution for infusion box of 4 bicompartiment pockets of 1000 ml

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
laboratory: Fresenius Kabi France

Injection solution for IV infusion
All forms

Indication

The indications are those of parenteral nutrition when enteral feeding is impossible, insufficient or contraindicated.

PEDIAVEN AP-HP G20 is indicated to meet the daily needs of nitrogen (amino acids of the L series), glucose, electrolytes, trace elements and fluid requirements of infants, children and adolescents, in a stable state, in particular without losses. excessive digestive and without severe undernutrition.

Dosage PEDIAVEN AP-HP G20 solution for infusion box of 4 bicompartiment pockets of 1000 ml

The indications are those of parenteral nutrition when enteral feeding is impossible, insufficient or contraindicated.

PEDIAVEN AP-HP G20 is indicated to meet the daily needs of nitrogen (amino acids of the L series), glucose, electrolytes, trace elements and fluid requirements of infants, children and adolescents, in a stable state, in particular without losses. excessive digestive and without severe undernutrition.

Against indications

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

· Congenital abnormality of amino acid metabolism,

· Severe renal insufficiency without the possibility of extra-renal treatment,

· Severe and uncontrolled hyperglycaemia

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

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

· Children in severe malnutrition.

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

Pediaven Ap-hp G20 side effects

Adverse effects related to parenteral nutrition in general can occur particularly at the beginning of treatment:

Classes of organ systems (SOC)

Unknown frequency (can not be estimated based on available data)

Immune system disorders

Hypersensitivity or allergic reactions to certain amino acids

Metabolism and nutrition disorders

Hyperglycemia, metabolic acidosis, hyperazotemia, hypercalcemia, hypervolemia

Gastrointestinal disorders

Nausea, vomiting

Hepatobiliary disorders

Transient impairment of liver function

Reactions occurring during an overdose (see section Overdose ) are usually reversible if the infusion is interrupted.

Immune system disorders:

If any unusual signs or symptoms of an allergic reaction occur such as sweating, fever, chills, headache, skin rash, or difficulty breathing, the infusion should be stopped immediately.

Metabolism and nutrition disorders:

· Hyperglycemia if the hourly flow rate of glucose infused exceeds the patient's glucose utilization capacity (variables according to age, pathological situation and associated treatments).

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

Poor conditions of use (excessive or inappropriate intake of the patient's needs or too fast a rate of infusion) can lead to signs of hyperglycemia, hypercalcemia and hypervolemia.

Renal and urinary disorders:

In case of excessive intake of amino acids, hyperazotemia can occur especially in cases of renal failure.

General disorders and administration site defects:

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

If in combination with ceftriaxone: Risk of precipitation of ceftriaxone-calcium salts (see sections Warnings and Precautions, Interaction with other medicinal products and other forms of interaction and Incompatibilities ):

Cases of renal precipitation have been reported in patients treated intravenously with ceftriaxone and solutions containing calcium, mainly in children over 3 years of age receiving high doses of ceftriaxone. The risk of precipitate formation increases in immobilized or dehydrated patients. This side effect may be asymptomatic or may cause kidney failure and anuria.

Cases of precipitation of calcium salts of ceftriaxone in the gallbladder have been reported, mainly in patients treated with ceftriaxone doses above the recommended doses. This adverse effect is usually asymptomatic but precipitation has been accompanied in rare cases by clinical symptoms such as pain, nausea and vomiting.

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. Healthcare professionals must 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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