SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Nutriflex basal Solution for Infusion

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Amounts of active substances in both the 1000 ml and 2000 ml sizes of the product before and after mixing of the two chambers are given below.

	Before Mixing		After Mixing	Before Mixing		After Mixing
	Lower Com-	Upper Com-		Lower Com-	Upper Com-
	partment	partment		partment	partment
Composition	600 ml	400 ml	1000 ml	1200 ml	800 ml	2000 ml
Isoleucine		1.88 g	1.88 g		3.76 g	3.76 g
Leucine		2.50 g	2.50 g		5.00 g	5.00 g
Lysine hydrochloride		2.27 g	2.27 g		4.54 g	4.54 g
(equivalent to lysine:)		(1.82 g)	(1.82 g)		(3.64 g)	(3.64 g)
Methionine		1.56 g	1.56 g		3.12 g	3.12 g
Phenylalanine		2.81 g	2.81 g		5.62 g	5.62 g
Threonine		1.45 g	1.45 g		2.90 g	2.90 g
Tryptophan		0.46 g	0.46 g		0.92 g	0.92 g
Valine		2.08 g	2.08 g		4.16 g	4.16 g
Arginine monoglutamate		3.98 g	3.98 g		7.96 g	7.96 g
(equivalent to arginine:)		(2.16 g)	(2.16 g)		(4.32 g)	(4.32 g)
(equivalent to glutamic acid:)		(1.82 g)	(1.82 g)		(3.64 g)	(3.64 g)
Histidine hydrochloride		1.35 g	1.35 g		2.70 g	2.70 g
monohydrate		(100 g)	(100 g)		(2.00 g)	(2.00 g)
(equivalent to histidine:)
Alanine		3.88 g	3.88 g		7.76 g	7.76 g
Aspartic acid		1.20 g	1.20 g		2.40 g	2.40 g
Glutamic acid		0.98 g	0.98 g		1.96 g	1.96 g
Glycine		1.32 g	1.32 g		2.64 g	2.64 g
Proline		2.72 g	2.72 g		5.44 g	5.44 g
Serine		2.40 g	2.40 g		4.80 g	4.80 g
Magnesium acetate tetrahydrate		1.23 g	1.23 g		2.46 g	2.46 g
Sodium acetate trihydrate		3.20 g	3.20 g		6.40 g	6.40 g
Potassium dihydrogen
Phosphate		1.74 g	1.74 g		3.48 g	3.48 g
Potassium hydroxide		0.96 g	0.96 g		1.92 g	1.92 g
Sodium hydroxide		0.10 g	0.10 g		0.20 g	0.20 g
Glucose monohydrate	137.5 g		137.5 g	275.0 g		275.0 g
(equivalent to glucose:)	(125.0 g)		(125.0 g)	(250.0 g)		(250.0 g)
Sodium chloride	1.40 g		1.40 g	2.80 g		2.80 g
Calcium chloride dihydrate	0.53 g		0.53 g	1.06 g		1.06 g

Electrolytes:
Sodium	23.9 mmol	26.0 mmol	49.9 mmol	47.8 mmol	52.0 mmol	99.8 mmol
Potassium		30.0 mmol	30.0 mmol		60.0 mmol	60.0 mmol
Calcium	3.6 mmol		3.6 mmol	7.2 mmol		7.2 mmol
Magnesium		5.7 mmol	5.7 mmol		11.4 mmol	11.4 mmol
Chloride	31.1 mmol	18.9 mmol	50.0 mmol	62.2 mmol	37.8 mmol	100.0 mmol
Phosphate		12.8 mmol	12.8 mmol		25.6 mmol	25.6 mmol
Acetate		35.0 mmol	35.0 mmol		70.0 mmol	70.0 mmol

Amino acid content		32 g	32 g		64 g	64 g
Nitrogen content		4.6 g	4.6 g		9.2 g	9.2 g
Carbohydrate content	125 g		125 g	250 g		250 g

Excipients:

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Solution for infusion

Infusion bag with two compartments

Amino acids and glucose solutions: clear, colourless or slightly yellowish aqueous solution

	1000 ml	2000 ml
Non-protein energy [kJ (kcal)]	2095 (500)	4190 (1000)
Total energy [kJ (kcal)]	2640 (630)	5255 (1255)
Osmolarity	1150 mOsm/l	1150 mOsm/l
pH	4.8 - 6.0	4.8 - 6.0

4.    Clinical Particulars

4.1.    Therapeutic indications

Parenteral nutrition with Nutriflex Basal is indicated when nutritional supplementation is required and enteral nutrition is inadequate or impossible. Such situations may occur following surgery, trauma or burns, or when gastrointestinal absorption of nutrients is impaired.

Nutriflex Basal contains a balanced mixture of essential and non essential amino acids, together with electrolytes and glucose.

4.2. Posology and method of administration

Shock and major acid base or electrolyte imbalance should be corrected before parenteral nutrition is commenced. Monitoring of nutritional and electrolyte status should be performed and trace element and vitamin levels should be assessed, particularly in the critically ill or those patients receiving prolonged parenteral nutrition.

In order to provide an appropriate input of calories and to fully metabolise the amino acids it is recommended that Nutriflex Basal be administered in conjunction with a 20% lipid emulsion, eg Lipofundin MCT 20%.

Volume of	Volume of	Nitrogen	Glucose	Total non
Nutriflex Basal	Lipid (20%)	(g)	(kcal)	Protein (kcal)

1000 ml	250 ml	4.6	500	1000
2000 ml	500 ml	9.2	1000	2000

Supplementation with further electrolytes, trace elements and vitamins may be required.

The above Nutriflex Basal with lipid regimes have an osmolarity of about 990 mOsml/l and are recommended to be administered by continuous infusion over 24 hours through a central vein. The rate of infusion should be controlled so as to avoid rapid administration of large volumes. 1000 ml should not be administered in less than six to eight hours.

Children: Not to be used in babies and infants up to the age of 24 months.

4.3. Contra-indications

Parenteral nutrition is contraindicated in the case of

•    Acute shock

•    Inborn errors of amino acid metabolism

•    Severe uraemia when dialysis facilities are not available

•    Irreversible hepatic failure

•    Renal failure where facilities for dialysis do not exist.

•    Babies and infants up to the age of 24 months because of their different nutritional requirements.

4.4. Special warnings and special precautions for use

As with all large volume infusion fluids, Nutriflex Basal should be administered with caution to patients with cardiac or renal dysfuntion. Care should be exercised in the administration of parenteral nutrition solutions containing amino acids to patients with altered amino acid metabolism, or with hepatic dysfunction.

As with other solutions containing glucose, administration of Nutriflex Basal may lead to hyperglycaemia. Blood glucose levels should be monitored and the rate of infusion adjusted or insulin administered if hyperglycaemia occurs.

Fluid, electrolyte and acid-base balance should be monitored. Administration of amino-acid solutions may cause acute folate deficiency and supplementary folic acid should be administered. Vitamin B12 status should be monitored and supplementation given if necessary.

As with all parenteral solutions administered through a central venous catheter, strict aseptic precautions should be taken when Nutriflex Basal is infused. Care should be taken to avoid complications of catheterisation including an air embolism and central venous thrombosis.

4.5. Interaction with other medicinal products and other forms of interaction

No interactions with other medicaments have been reported with Nutriflex Basal.

4.6. Pregnancy and lactation

Animal reproduction studies have not been performed with Nutriflex basal. There are however, published reports of successful and safe administration of its components during pregnancy in the human.

Nevertheless, medicines should not be used in pregnancy especially in the first trimester unless the expected benefit is thought to outweigh any possible risk to the fetus.

Breast-feeding is not recommended if women need parenteral nutrition in that time.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Nausea may occasionally occur. If the recommended infusion rate is exceeded, vomiting, sweating and flushing may occur. Abnormal results of liver function tests and cholestasis have been reported in some patients receiving parenteral nutrition.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

Gross overdosage during total parenteral nutrition may lead to complications such as acidosis, hyperosmolar coma, hyperammonaemia. If Nutriflex Basal is administered at the recommended rates no such problems are to be anticipated.

5. Pharmacological Properties

5.1. Pharmacodynamic properties

Nutriflex Basal contains the eight essential amino acids accompanied by semiessential and non-essential amino acids and essential electrolytes in the optimum proportions necessary in cases of catabolism. Nitrogen balance being directly dependent on the energy/nitrogen ratio, the glucose contained in Nutriflex provides an optimum level of kcal/g of nitrogen ratio for an adequate nutritional supply.

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Citric acid monohydrate Water for injections

6.2    Incompatibilities

No additive or other component should be added to the medicinal product unless compatibility has been proven in advance. See also section 6.6.

Shelf life

Unopened

2 years

After first opening the container

The product should be administered immediately after connecting to infusion set. Partially used containers must not be stored for later use.

After mixing of the contents

Ideally after mixing the two solutions, Nutriflex basal should be administered immediately but it can in special circumstances be stored for up to 7 days at room temperature and up to 14 days if stored in a refrigerator (including administration time).

6.4 Special precautions for storage

Do not store above 25 °C.

Keep bag in the outer carton in order to protect from light.

6.5    Nature and contents of container

Flexible plastic bag made of a dual-layer film consisting of polyamide (external layer) and polypropylene (internal layer). The container is divided into two compartments, separated by an internal peel seam, of either 400 ml and 600 ml or 800 ml and 1200 ml. Opening the peel seam results in an aseptic mixing of the two solutions.

Each bag is packed in a protective plastic bag.

Nutriflex basal is supplied in two-chamber plastic bags containing:

- 1000 ml (400 ml of amino acids solution + 600 ml of glucose solution)

- 2000 ml (800 ml of amino acids solution + 1200 ml of glucose solution)

Pack sizes: 5 x 1000 ml, 5 x 2000 ml Not all pack sizes may be marketed.

6.6    Special precautions for disposal

No special requirements are needed for disposal of container, overwrap and oxygen absorber.

The design of the dual chamber bag permits aseptic mixing of amino acids, glucose and optional fat in the lower chamber. The addition of further electrolytes is possible if required.

Immediately before use the internal peel seam between the two compartments must be opened allowing the respective contents to be aseptically mixed.

Remove the bag from its protective bag and proceed as follows:

-    Open out the bag and lay on a solid surface

-    Open the peel seam by using pressure with both hands

-    Briefly mix the contents of the bag together.

An additive port is provided for admixing of supplements to Nutriflex basal.

Only mixtures of known compatibility should be prepared. Information on compatibility is available from the manufacturer.

When admixing other solutions or fat emulsions to Nutriflex basal, aseptic precautions must be strictly observed. Fat emulsions can be easily admixed by means of a special transfer set.

After infusion, any remaining solution should never be stored for later use. Only completely clear solutions from undamaged containers are to be used.

7. MARKETING AUTHORISATION HOLDER

B.Braun Melsungen AG Carl-Braun-Strasse 1 D-34212 Melsungen Germany

8. MARKETING AUTHORISATION NUMBER(S)

PL 03551/0022

9.    DATE OF FIRST AUTHORISATION / RENEWAL OF THE

AUTHORISATION

18^th September 1996

10 DATE OF REVISION OF THE TEXT

03/09/2014