Aminoven Infant 10 % Solution for infusion
Clinical Summary
Quick overview from the medicine insert
Indication
Aminoven Infant 10% is indicated for the nutritional support of infants requiring parenteral nutrition, particularly in cases of inborn errors of metabolism or malabsorption syndromes.
Dosage (summary)
The dosage should be individualized based on the patient's nutritional requirements and clinical condition. Typically, it is administered as an infusion at a rate determined by the healthcare provider.
Onset of Action / Duration
The onset of action is immediate upon administration, with effects lasting as long as the infusion is maintained.
Special Populations
- Neonates
- Infants
- Patients with liver dysfunction
Pregnancy & Breastfeeding
Safety during pregnancy and lactation has not been established. Use only if the potential benefit justifies the potential risk to the fetus or infant.
Key Drug Interactions
- May interact with other parenteral nutrition components, requiring careful monitoring of electrolytes and amino acid levels.
- Caution is advised when used with medications that affect liver function.
Contraindications
- Hypersensitivity to any of the active ingredients.
- Severe liver dysfunction.
- Metabolic disorders that contraindicate amino acid administration.
Common side effects
- Hyperammonemia
- Electrolyte imbalances
- Gastrointestinal disturbances
- Allergic reactions
Counselling Points
- Ensure proper administration technique to avoid complications.
- Monitor for signs of allergic reactions or adverse effects.
- Regularly assess nutritional status and adjust dosage as necessary.
Serious warnings
- Use with caution in patients with renal impairment.
- Monitor for potential metabolic complications, especially in neonates and infants.
Important Disclaimer
The Aminoven Infant 10 % Solution for infusion professional information leaflet below is the property of Fresenius Kabi South Africa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
AMINOVEN INFANT 10 % is a nitrogen source for partial parenteral nutrition therapy of infants (preterm and term newborns, babies) and young children when oral or enteral nutrition is impossible, insufficient or contraindicated. Together with required amounts of carbohydrates and fat as energy sources as well as vitamins, electrolytes and trace elements, the composite solution may serve for total parenteral nutrition.
4.2 Posology and method of administration
Posology
Maximum infusion rate: Up to 0,1 g amino acids/kg body weight/hour = 1,0 ml/kg body weight/hour
Maximum daily dose: - at the age of 1 year:
1,5 u2013 2,5 g amino acids/kg body weight = 15 u2013 25 ml per kg body weight
- at the age of 2 u2013 5 years: 1,5 g amino acids/kg body weight = 15 ml per kg body weight
- at the age of 6 u2013 14 years: 1,0 g amino acids/kg body weight = 10 ml per kg body weight
The solution is administered as long as parenteral nutrition is required.
Method of administration
AMINOVEN INFANT 10 % should be administered as a constant intravenous infusion via a central vein. AMINOVEN INFANT 10 % should be used with sterile transfer equipment immediately after opening. Any unused solution should be discarded. Only clear, particle-free solutions in undamaged containers should be used. For long-term parenteral nutrition with AMINOVEN INFANT 10 % essential fatty acids, vitamins and trace elements should be substituted.
4.3 Contraindications
The administration of AMINOVEN INFANT 10 % is contraindicated in the following conditions: Disturbances of amino acid metabolism, inborn errors of amino acid metabolism, metabolic acidosis, hyperhydration and hyperkalaemia. Patients with insufficient renal or hepatic function require an individual dosage. Attention in case of hyponatraemia. General contraindications to parenteral nutrition are unstable life-threatening circulatory conditions (shock), acid-base balance disturbances, insufficient cellular oxygen supply, hyperhydration, electrolyte disturbances, hyperlactataemia, and increased serum osmolarity, pulmonary oedema, decompensated cardiac insufficiency, and known sensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Frequent evaluation and determination of the following laboratory values should be recommended for monitoring parenteral nutrition in infants: Urea-nitrogen, ammonia, electrolytes, glucose and triglycerides (when a fat emulsion is administered), acid-base and fluid balance, liver enzymes and serum osmolality. Infusion via peripheral veins in general can cause irritation of the vein wall and thrombophlebitis. To minimise the risk of vein irritation, daily inspections of the insertion site are recommended. Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products. When used in neonates and children below 2 years, AMINOVEN INFANT 10 % should be protected from ambient light until administration is completed (see sections 4.2, 6.3 and 6.6).
Special patient groups
Renal / hepatic impairment See section 4.3.
Use in the elderly No specific studies have been performed.
Effects on laboratory tests No specific studies have been informed.
4.5 Interaction with other medicines and other forms of interaction
No interactions are known to date.
4.6 Fertility, pregnancy and lactation
Studies with this product have not been carried out on pregnant women. However, the clinical experience with similar parenteral amino acid solutions has not shown evidence of risk in pregnant and breastfeeding women.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
None known when correctly administered.
Vascular disorders: Frequent: Thrombophlebitis and irritation of the cell wall especially when administered peripherally.
Gastrointestinal disorders: Frequency unknown: Too rapid infusion may lead to nausea and vomiting. Gastric hyperacidity, which should be treated with H 2 antagonists.
General disorders: Frequency unknown: Too rapid infusion may lead to shivering attacks. Renal losses with subsequent amino acid imbalances may occur if the infusion is too rapid. Where the contraindications, precautions and dosage recommendations are adhered to, adverse reactions are unknown.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.
4.9 Overdose
As with other amino acid solutions shivering, vomiting, nausea and increased renal amino acid losses can occur when AMINOVEN INFANT 10 % is given in overdose or the infusion rate is exceeded. Infusion should be stopped immediately in this case. In the event of hyperkalaemia the infusion of 200 to 500 ml 10 % glucose solution with an added 1 to 3 U modified insulin / 3 - 5 g glucose is advisable.
