Medine.co.uk

Vamin 14

Document: spc-doc_PL 08828-0119 change

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