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1. Vaminolact
2. Vaminolact

Solution of amino acids for intravenous infusion in parenteral nutrition.

4    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Clinical conditions in children when enteral supply of protein is insufficient, undesirable or impossible.

4.2. Posology and Method of Administration

Route of administration: Intravenous

Recommended dosage for infants and children

Body weight    Dosage

(kg)    ml/kg bw/24 hours

Neonates (including LBW)	Up to 10	8 - 35
and infants (up to 10 kg)		(To be increased gradually during the first week of life)

Solution should be administered as a continuous infusion over 24 hours using a suitable pump.

Body weight    Dosage

(kg)    ml/kg bw/24 hours

Children    10    24

20    18.5

30    16

40    14.5

>40    **

The solution should be infused over 24 hours. (**0.5-2.0 litres per 24 hours or 0.8-1.6 g amino acid/kg bw/day. Infusion should be at a rate of 2.0-2.8 ml per minute (40-55 drops per minute). This corresponds to an infusion time of approximately 6-8 hours per litre).

Recommended dosage for adults (including the elderly)

Not applicable.

Administration

To achieve optimum utilisation of administered amino acids, adequate energy sources, e.g. glucose and lipid emulsion (Intralipid®) should be provided together with electrolytes, trace elements (Peditrace® or Additrace®) and vitamins (Solivito® N, Vitlipid® N Infant or Vitlipid® N Adult).

As with all infusions, care should be taken to avoid complications of catherisation including air embolism and central venous thrombosis. Strict asepsis should be maintained especially in the immunosuppressed patient.

Hypertonic preparations such as amino acid solutions and concentrated glucose solutions are commonly infused into a central vein. Vaminolact may also be infused into a peripheral vein when given simultaneously with a fat emulsion (Intralipid) through the same cannula, since the reduced osmolality of the overall mixture may reduce the risk of thrombophlebitis.

For safe administration of intravenous fluids from non-collapsible containers, a giving set with integral airway is recommended.

4.3. Contra-Indications

Vaminolact is contraindicated in patients with irreversible liver damage and in severe uraemia where dialysis facilities are not available.

4.4.    Special Warnings and Special Precautions for Use

In extremely sick, premature and small babies requiring neonatal intensive care, liver function is likely to be immature and/or disturbed. Amino acids which, to a large extent, are metabolised by the liver may therefore accumulate in plasma. In this clinical condition, monitoring of amino acid concentration during therapy is advisable.

Care must be exercised in the administration of large volume infusion fluids to patients with cardiac insufficiency. Amino acid infusions must also be administered with caution to patients with disturbances in protein metabolism. Hyperkalaemia, hypernatraemia and acidosis should be corrected prior to commencement of intravenous nutrition; serum electrolytes, blood glucose levels, acid base balance and fluid levels should be regularly monitored.

4.5.    Interactions with other Medicinal Products and other Forms of Interaction

Amino acid solutions may precipitate acute folate deficiency and folic acid should be given daily.

4.6. Pregnancy and Lactation

Not applicable.

4.7. Effects on Ability to Drive and Use Machines

Not applicable.

4.8. Undesirable Effects

Nausea may occur rarely. Thrombophlebitis may occur when peripheral veins are used, but the incidence is reduced by the simultaneous infusion of a fat emulsion.

Abnormal liver function tests have been observed during intravenous infusion, but these return to normal when artificial feeding is stopped. Cholestasis has been reported in some patients receiving intravenous nutrition.

4.9. Overdose

Infusion rates and volumes should be carefully monitored in infants.

Excessive infusion rates may result in nausea, vomiting, flushing and sweating. The effects of overdosage are likely to be due to the volume infused and the hypertonicity of the solution, i.e. circulatory overload. The amount required to produce this effect will vary depending on the patient's age, weight and general condition. There are no specific antidotes for overdosage.

In cases of suspicion of overdosage the infusion should be stopped.

Emergency procedures should be general supportive measures, respiratory and cardiovascular. Close biochemical monitoring would be essential and specific abnormalities treated appropriately, perhaps by the careful infusion of hypotonic solutions and concomitant diuretic therapy, and administration of sodium bicarbonate for metabolic acidosis.

PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Vaminolact is formulated to supply essential and non essential amino acids based on the protein profile of human breast milk. It includes taurine (2 aminoethane), a sulphonic amino acid and an end product of methionine and cysteine metabolism. Endogenous formation of taurine is either absent or limited in the neonate and due to the lack of necessary enzymes, taurine is considered an essential amino acid in the neonate. It has been demonstrated that taurine plays an important role in growth, development of the brain and maturation of retinal function and is also involved in hepatic biliary conjugation, especially in the neonate where bile acids are conjugated almost exclusively with taurine until some time after birth. Vaminolact also includes cysteine and tyrosine which seem to be essential for neonates.

5.2. Pharmacokinetic Properties

The distribution and metabolism of intravenously infused amino acids is well known and is similar to that of dietary protein. However, there are differences, one of which is that when dietary protein is metabolised, the liver is exposed to high concentrations of amino acids as the protein enters the systemic system via the portal vein and the liver.

With slow infusion of Vaminolact the amino acids enter the systemic circulation directly and hence the excessive elevation of plasma amino acids and urinary loss is avoided. Taurine is metabolised mainly by urinary excretion and by conjugation with bile acids.

5.3. Pre-clinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6 PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Water for injections, Ph Eur.

Incompatibilities

Additions to Vaminolact should only be made where compatibility is known.

6.3.    Shelf Life

Two years

6.4.    Special Precautions for Storage

Do not store above 25°C. Do not freeze.

6.5.    Nature and Content of Container

Lightweight glass bottle (Ph Eur, Type II) sealed with a butyl rubber stopper containing 100 or 500 ml of solution.

Pack size:

12 x 100 ml 12 x 500 ml

10 x 100 ml 10 x 500 ml

6.6.    Instructions for Use, Handling and Disposal

Do not use if the bottle is leaking or if the solution is cloudy or contains a precipitate. Discard any unused contents.

Electrolyte requirements should be individually assessed.

All additions should be made aseptically.

The manufacturer can be contacted for full information on complete and balanced intravenous nutrition regimens.

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