SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Intrafusin 11

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1000 ml bottle of Intrafusin 11 contains:

Isoleucine	Ph. Eur.	2.1 g
Leucine	Ph. Eur.	2.85 g
L-Lysine-L-Glutamate.2H2O		7.58 g
(equivalent to Lysine and		3.38 g
Glutamic acid)		3.38 g
Methionine	Ph. Eur.	2.70 g
Phenylalanine	Ph. Eur.	2.03 g
Threonine	Ph. Eur.	2.70 g
Tryptophan	DAB	1.05g
Valine	Ph. Eur.	2.33 g
Arginine	Ph. Eur.	6.98 g
Histidine	Ph. Eur.	1.73 g
N-Acetyl-L-cysteine	Ph. Eur.	0.53 g
Glycine	Ph. Eur.	7.80 g
Alanine	Ph. Eur.	12.97 g
Glutamic acid	Ph. Eur.	4.70 g
Proline	Ph. Eur.	7.05 g
Serine	Ph. Eur.	7.05 g
N-Acetyl-L-tyrosine	DAB	1.13 g
Total amino acids		73.28g
Glycerol-1(2)-dihydrogen-phosphate	Ph. Franc	6.11 g
mixture of disodium salt, (30%/70% w/w).5H2O Potassium hydrogen glutamate.H2O		4.06 g
Sodium chloride	Ph. Eur.	2.34 g
Potassium chloride	Ph. Eur.	1.49 g
Citric acid	Ph. Eur.	1.15 g
Magnesium chloride.6H2O	Ph. Eur.	1.02 g
Calcium chloride.2H2O	Ph. Eur.	0.44 g

1000 ml Intrafusin 11 provides electrolytes equivalent to:

Sodium

Potassium

Calcium	3 mmol
Magnesium	5 mmol
Chloride	76 mmol
Phosphate	20 mmol
Citrate	6 mmol
Product properties
Energy content/litre	300 kcal
Nitrogen content/litre	11.4 g
Osmolality	800 mosmol/kg water
pH	6.1
Titratable acidity (pH 7.4) approx.	21.5 mmol/l
Acetate	Nil

3 PHARMACEUTICAL FORM

Solution of amino acids with electrolytes for intravenous infusion.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

To be used as part of an intravenous parenteral nutrition regimen which is indicated whenever oral feeding is impossible or inadequate.

4.2 Posology and Method of Administration

For intravenous infusion.

Dosage and administration: The amount of Intrafusin 11 to be administered daily is calculated according to individual patients requirements of nitrogen, fluid etc.

Recommended dosage for adults (including the elderly): Adults should receive 1.0g- 2.0g amino acids/kg body weight/day which equates to approximately 13-27 ml/kg body weight/day. In a 70 kg patient this corresponds to approximately 1000-2000 ml/day.

Pregnant women and post-operative patients should receive 1.6-2.0 g amino acids/kg body weight/day.

An infusion rate of 1.8-2.6 ml/kg body weight/hour is recommended, which in a 70 kg patient corresponds to 125-180 ml/hour. The infusion rate should not

exceed 2.6 ml/kg body weight/hour. One litre of solution should be given over not less than 7-8 hours.

Recommended dosage for children: The product is not recommended for use in children.

4.3 Contra-Indications

Intrafusin 11 is contraindicated in patients suffering from severe shock, hyperkalaemia, severe disturbances of liver or kidney function and disturbance of amino acid metabolism.

4.4 Special Warnings and Precautions for Use

The effects of Intrafusin 11 should be carefully controlled when given to patients who tend toward elevated serum potassium or urea levels. Too rapid an infusion may result in renal losses, and nausea in sensitive patients.

A pre-existing deficiency of vitamins and, in particular, folic acid and vitamin B12 may become clinically evident during intravenous nutrition with amino acids. Regular checks of the patients’ vitamin B12 status and folate demand are therefore recommended. Prophylactic administration of adequate vitamins should be given if required.

The solution of Intrafusin 11 should be clear at all times before infusion. Discard the solution if a precipitate or severe discolouration occurs.

4.5 Interactions with other Medicaments and other forms of Interaction

None known.

4.6 Pregnancy and Lactation

None known.

4.7 Effects on Ability to Drive and Use Machines

Not applicable.

4.8 Undesirable Effects

Not expected.

4.9 Overdose

In the event of fluid or solute overload during parenteral therapy, re-evaluate the patient’s condition and institute appropriate corrective treatment.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

The pharmacological actions (over and above the normal physiological function) of the amino acids and electrolytes present in the Intrafusin 11 formulation are well documented. The concentration and rate of infusion is designed to maintain normal physiological levels of amino acids and electrolytes. No pharmacological effects are therefore expected.

5.2 Pharmacokinetic Properties

The distribution and elimination of amino acids is dependent on the physiological status of the patient. Whilst normal limits for each can be defined, the rate of elimination may be very variable.

This formulation of amino acids is intended to normalise circulating amino acid levels and the composition and rate of administration are designed to achieve this.

The N-Acetyl amino acids are rapidly deacetylated to give the respective free amino acids.

5.3 Preclinical Safety Data

No further pre-clinical safety data are available.

6.1    List of excipients

Water for Injections    Ph. Eur.

6.2    Incompatibilities

Additions to the amino acid solution or giving set should be avoided unless compatibility is known. The preparation contains Ca²+ ions. If solutions of inorganic phosphate, hydrogencarbonate/carbonate or oxalate are added, precipitates may form.

6.3    Shelf Life

36 months.

6.4    Special Precautions for Storage

Store between 15°C-25°C. Protect from light.

6.5    Nature and Contents of Container

Glass bottle (Ph. Eur. Type II) with butyl rubber or ethylene propylene terpolymer stopper containing 500 or 1000 ml of solution.

6.6    Instruction for Use/Handling

The manufacturer can be consulted for further stability information on parenteral nutrition regimens containing Intrafusin 11.

7    MARKETING AUTHORISATION HOLDER

Fresenius Kabi Limited Cestrian Court Eastgate Way Manor Park