Vaminolact

Each 1000-mL Vaminolact contains Alanine 6.3 g, Arginine 4.1 g, Aspartic acid 4.1 g, Cysteine (+ L-cystine) 1 g, Glutamic acid 7.1 g, glycine (aminoacetic acid) 2.1 g, histidine 2.1 g, isoleucine 3.1 g, leucine 7 g, lysine 5.6 g, methionine 1.3 g, phenylalanine 2.7 g, proline 5.6 g, serine 3.8 g, taurine 0.3 mg, threonine 3.6 g, tryptophan 1.4 g, tyrosine 0.5 mg, valine 3.6 g.
Total Amount of Amino Acids: 65.3 g/L of which 31.9 g, including cysteine, histidine and tyrosine, are essential.
pH: 5.2. Osmolality: 510 mOsmol/kg water. Nitrogen Content: 9.3 g/L.
Electrolytes: None.
Energy Content and Antioxidant Additives: 1 MJ/L (240 kcal/L).
Vaminolact also contains water for injections to make 1000 mL.

Amino acid solution for IV nutrition.
Pharmacology: Pharmacodynamics: The amino acid composition of Vaminolact is based on that of human milk. Vaminoclact contains the 18 essential and non-essential amino acids needed for synthesis of body proteins. Furthermore, it contains taurine, an aminosulfuric acid which is also present in human milk.
The intracellular concentration of taurine is normally high, particularly in the mature retina, in muscle and in developing brain tissue. In children, long term IV nutrition without taurine has induced low taurine levels and altered electro-retinograms which normalised after taurine supplementation.
Vaminolact has been shown to result in positive nitrogen balance in preterm and terms of infants. Vaminolact does not contain carbohydrates and is electrolyte-free to allow individually adjusted administration.
To ensure maximal utilisation of the infused amino acids for protein synthesis, the patient's requirements of energy (given as carbohydrates and fat), vitamins and trace elements should be met. Glucose is recommended as the source of carbohydrates.

As a source of amino acids for protein synthesis and of taurine in infants and children requiring IV nutrition.

Recommended Dosage: Children 40-kg body weight: 14.5 mL/kg daily**; 30-kg-body weight: 16 mL/kg daily**; 20-kg body weight: 18.5 mL/kg daily**; 10-kg body weight: 24 mL/kg daily**.
Infants: Up to 35 mL/kg body weight/24 hrs, the full dosage being reached by gradual increases during 1st week of administration*.
*The dosage should be gradually increased to this value during the 1st week of life and the infusion should preferably be given continuously over 24 hrs.
**The duration of infusion should be atleast 8 hrs.
Administration: Vaminolact may be infused into the same central of peripheral vein as glucose and fat emulsion by means of a y-connector near the infusion site. Discard any unused contents.

Vomiting, flushing and sweating have been observed if Vaminolact is administered at a higher rate than recommended.
In case of symptoms due to overdose, the infusion should be slowed down or discontinued.

Patients with inborn errors of amino acid metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available.

Intravenous infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and, in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition.

Nausea occurs rarely. Transient increases in liver functions tests during IV nutrition have been reported. The reasons are at present unclear. The underlying disease, the components and their amounts in the IV feeding regimens have been suggested.
Hypersensitivity reactions have been reported with amino acid solutions.
As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of Intralipid.

Not to be expected.
Compatibility: The following can be added to Vaminolact 500 mL, separately or together, without risk of precipitation: Up to sodium 200 mmol , potassium 160 mmol  as chloride, 35 mmol calcium as gluconate and magnesium 15 mmol  as sulphate and up to Peditrace 30 mL. Additions should be performed aseptically immediately before the start of the infusion.

Store below 25°C. Do not freeze.
Shelf-Life: 24 months.

Parenteral Nutritional Products

B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.

P₁S₁S₃