Vamin 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vamin 14 Electrolyte free
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Alanine |
Ph.Eur. |
12.0g |
|
Arginine |
Ph.Eur. |
84g |
|
Aspartic Acid |
Ph.Eur. |
2.5g |
|
L-Cysteine/Cystine |
USP |
420mg |
|
Glutamic Acid |
Ph.Eur. |
4.2g |
|
Glycine |
BP |
59g |
|
L-Histidine |
USP |
51g |
|
Isoleucine |
Ph.Eur. |
4.2g |
|
Leucine |
Ph.Eur. |
59g |
|
L-Lysine |
USP |
6.8g |
|
L-Methionine |
Ph.Eur. |
4.2g |
|
Phenylalanine |
Ph.Eur. |
59g |
|
Proline |
Ph.Eur. |
51g |
|
Serine |
Ph.Eur. |
3.4g |
|
L-Threonine |
USP |
4.2g |
|
L-Tryptophan |
USP |
14g |
|
L-Tyrosine |
USP |
170mg |
|
Valine |
Ph.Eur. |
5.5g |
3 PHARMACEUTICAL FORM
Clear, colourless to straw coloured solution of L-amino acids.
4
CLINICAL PARTICULARS
Therapeutic indications
4.1
Vamin 14 Electrolyte free is indicated for the prophylactic or therapeutic treatment of protein depletion, where sufficient enteral feeding is impossible or impracticalble.
4.2 Posology and method of administration
For intravenous use only.
Recommended dosage for adults
Depending upon patient requirements up to one litre intravenously per 24 hours.
Vamin 14 Electrolyte free is administered by slow intravenous infusion at approximately 40 drops per minute or slower corresponding to an infusion time of at least eight hours per litre.
Recommended dosage for infants
Can be administered at the physician’s discretion. An amino acid solution containing larger amounts of cysteine/cystine and tyrosine may be considered more appropriate in infants.
Recommended dosage for the elderly
Age per se requires no adjustment of the adult dosage.
However, caution should be exercised in the “frail” elderly, and indeed in all patients with poor renal, cardiac or liver function, where smaller volumes should be used depending on the individual patients’ requirements and condition.
4.3 Contraindications
Vamin 14 Electrolyte free is contraindicated in patients with irreversible liver damage and in severe uraemia when dialysis facilities are not available.
4.4 Special warnings and precautions for use
• 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 Interaction 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
Animal reproduction studies have not been carried out with Vamin 14 Electrolyte free. However, there are published reports on the successful and safe infusion of amino acid solutions during pregnancy in the human.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Vomiting, flushing and sweating may occur, rarely, particularly if the recommended rate of infusion is exceeded. 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.
Thrombophlebitis may occur when peripheral veins are used but the incidence is reduced by the simultaneous infusion of fat emulsion.
4.9 Overdose
(In general, significant overdosage with Vamin 14 Electrolyte free does not occur). 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. circulating overload. The amount required to produce this effect will vary depending on the patients’ condition, cardiac and renal status.
There are no specific antidotes for overdosage.
In case of suspicion of overdosage the infusion should immediately be stopped.
Emergency procedure 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Vamin 14 Electrolyte free is formulated to supply amino acids in the physiological L-form for intravenous nutrition.
5.2 Pharmacokinetic properties
Vamin 14 Electrolyte free is an amino acid solution without interest for pharmacokinetic studies.
5.3 Preclinical safety data
No further preclinical safety data is available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Acetic Acid Glacial Ph. Eur.
Water for Injections Ph. Eur.
6.2
Incompatibilities
Additives may only be added to Vamin 14 Electrolyte free where compatibility is known.
6.3 Shelf life
24 months.
6.4 Special precautions for storage
Not applicable
6.5 Nature and contents of container
Light weight glass bottle (Ph. Eur. Type II) with butyl rubber stopper, 31mm (FM 157) containing 500 or 1000 ml of solution.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
8 MARKETING AUTHORISATION NUMBER(S)
PL 08828/0119
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/03/2009
10
DATE OF REVISION OF THE TEXT
10/03/2009