Aminoven 8, solution for infusion, bottle

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Isoleucine; Leucine; Lysine acetate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine; Alanine; Glycine; Proline; Serine; Tyrosine; Taurine
Available from:
Fresenius Kabi Limited
ATC code:
B05BA; B05BA01
INN (International Name):
Isoleucine; Leucine; Lysine acetate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine; Alanine; Glycine; Proline; Serine; Tyrosine; Taurine
Dosage:
5 gram(s)/litre
Pharmaceutical form:
Solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Solutions for parenteral nutrition; amino acids
Authorization status:
Not marketed
Authorization number:
PA0566/002/001
Authorization date:
1999-09-07

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aminoven

®

8 Solution for Infusion

Aminoven

®

16 Solution for Infusion

Aminoven

®

25 Solution for Infusion

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Aminoven is and what it is used for

2. What you need to know before you receive Aminoven

3. How to use Aminoven

4. Possible side effects

5. How to store Aminoven

6. Contents of the pack and other information

1. What Aminoven is and what it is used for

Aminoven provides nourishment straight into your blood stream when you cannot eat normally. It provides

amino acids which your body will use to make proteins (to build and repair muscles, organs, and other body

structures).

Aminoven is typically mixed in a pharmacy with fat, carbohydrates, salts and vitamins, which together

provide your complete nutritional needs.

This leaflet covers 3 products:

Aminoven 8 Solution for Infusion

Aminoven 16 Solution for Infusion

Aminoven 25 Solution for Infusion

In this leaflet the three solutions are collectively referred to as Aminoven.

2. What you need to know before you receive Aminoven

You should not receive Aminoven if you are suffering from, or have suffered from the following.:

Do not use Aminoven:

if you have a condition where your body has problems using proteins or amino acids

if you have metabolic acidosis (the acid levels of your body fluids and tissues become too high)

if you have reduced kidney function and are not on dialysis or another form of blood filtration treatment

if you have seriously reduced liver function

inf you have fluid retention

if you suffer from shock

if you have hypoxia (low levels of oxygen)

if you have a decompensated heart failure

Aminoven 8 and 16 should not be used for children below 2 years of age.

Aminoven 25% should not be used for children and adolescents below 18 years of age.

For children under 2 years, paediatric amino acid preparations which are formulated to meet their different

metabolic needs should be used.

Warnings and precautions

Inform your doctor if you:

suffer from low levels of potassium (hypokalaemia)

suffer from low levels of sodium (hyponatraemia)

suffer from folate deficiency

suffer from heart failure (cardiac insufficiency)

The doctor or nurse will check that the solution is particle free before usage.

Other medicines and Aminoven

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription.

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant, if you think you are pregnant or if you are breastfeeding.

The doctor will decide if you should receive Aminoven.

Driving and using machines

Aminoven infusion has no effect on driving or using machines.

3. How to use Aminoven

You will receive your medicine by infusion (IV drip).

The amount and rate at which the infusion is given depends on your requirements.

Your doctor will decide on the correct dose for you to receive.

You may be monitored during your treatment.

If you use more Aminoven than you should

It is very unlikely that you will receive more infusion than you should as your doctor or nurse will monitor

you during the treatment. The effects of an overdose may include nausea, vomiting and shivering. If you

experience these symptoms or believe that you have received too much Aminoven inform your doctor or

nurse immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aminoven can cause side effects, although not everybody gets them.

The following side effects have been observed when infusion was administered too quickly:

loss of potassium or sodium from the blood

folate deficiency

At the site of injection the following side effects may occur:

soreness and tenderness of the vein

thrombosis (the formation of a clot) in the vein where the injection is given

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this

leaflet. You can alsoreport side effects directly (see details below). By reporting side effects you can help

provide more information on the safety ofthis medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

The following information is intended for medical or healthcare professionals only:

Posology and method of administration

The daily requirement of amino acids depends on the body weight and the metabolic conditions of the

patient.

The maximum daily dose varies with the clinical condition of the patient and may even change from day to

day.

The recommended infusion period is to provide a continuous infusion for at least 14 hours up to 24 hours,

depending on the clinical situation. Bolus administration is not recommended.

The solution is administered as long as a parenteral nutrition is required.

Aminoven 8:

For administration via a peripheral or central vein as a continuous infusion.

The usual daily dose Aminoven 8 is 16 - 20 ml of per kg body weight (equivalent to 0.8 - 1.0 g amino acids per

kg body weight) e.g. corresponding to 1120 - 1400 ml Aminoven 8 at 70 kg body weight.

Maximum infusion rate is 2.0 ml of Aminoven 8 per kg body weight per hour (equivalent to 0.1 g amino acids

per kg body weight and hour).

Maximum daily dose to adults

20 ml of Aminoven 8 per kg body weight/day (equivalent to 1.0 g amino acids per kg body weight) e.g.

corresponding to 70 g amino acids at 70 kg body weight. For an increased amino acids dosage suitable

preparations are available.

Maximum daily dose to children and adolescents (2-18 years) 40 ml of Aminoven 8 per kg body weight/day

(equivalent to 2.0 g amino acids per kg body weight/day) but total daily fluid intake must be considered.

Aminoven 16:

For administration via a central vein as a continuous infusion.

The usual daily dose Aminoven 16 is 10 - 20 ml per kg body weight equivalent to 1.0 - 2.0 g amino acids per

kg body weight) e.g corresponding to 700 - 1400 ml Aminoven 16 at 70 kg body weight.

Maximum daily dose to adults, adolescents and children (from 2 years)

20 ml of Aminoven 16 per kg body weight/day (equivalent to 2.0 g amino acids per kg body weight) e.g.

corresponding to 1400 ml Aminoven 16 or 140 g amino acids at 70 kg body weight.

Aminoven 25

For administration via a central vein as a continuous infusion.

The usual daily dose Aminoven 25 is 6.7-13.3ml per kg body weight (equivalent to 1.0-2.0g amino acids per

kg body weight) corresponding to 470 to 930ml Aminoven 25 at 70kg body weight.

V005

Product Name:

Type of Packaging:

Dosage:

Territory:

Pharma-Code (Laetus)

Code:

Font:

Smallest Size:

2-D-Matrix Code

Material number:

Colour:

BLACK

DIE CUT

1. Draft

16.08. 2017 12.09 Uhr

Variable Data:

Operator: Patrick Marko +43(0) 34 52 72266-20

AMINOVEN 25 (15%)

GB

PIL

6x1000ml

M094180/06 GB

x

M094180/06 GB

Antique Olive

9 Pt.

Dimension:

180 x 588 mm

M094180/06 GB

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

5. How to store Aminoven

Keep this medicine out of the reach and sight of children. Your doctor and hospital pharmacist are

responsible for the correct storage, use and disposal of Aminoven infusion.

Do not freeze and always keep the container in the outer carton.

The solution must not be used after the expiry date shown on the label.

Any solution remaining after treatment should be disposed of via approved hospital procedures.

6. Contents of the pack and other information

What Aminoven solution for infusion contains

Each 1000 ml of Aminoven contains the following active ingredients:

Active

Ingredients

Quantity (g)

Aminoven

Aminoven

Aminoven

Isoleucine

2.50

5.00

5.20

Leucine

3.70

7.40

8.90

Lysine acetate

4.655

9.31

15.66

Methionine

2.15

4.30

3.80

Phenylalanine

2.55

5.10

5.50

Threonine

2.20

4.40

8.60

Tryptophan

1.00

2.00

1.60

Valine

3.10

6.20

5.50

Arginine

6.00

12.00

20.00

Histidine

1.50

3.00

7.30

Alanine

7.00

14.00

25.00

Glycine

5.50

11.00

18.50

Proline

5.60

11.20

17.00

Serine

3.25

6.50

9.60

Tyrosine

0.20

0.40

0.40

Taurine

0.50

1.00

2.00

Aminoven 8 and Aminoven 16 also contain glacial acetic acid and water for injections.

Aminoven 25 also contains glacial acetic acid, water for injections and malic acid.

What Aminoven looks like and contents of the pack

Aminoven 8 and Aminoven 16 are available in colourless glass bottles with a rubber closure/aluminium cap

that contain 500 ml or 1000 ml of solution.

Aminoven 25 is available in colourless glass bottles with a rubber closure/aluminum cap that contains

250ml, 500ml or 1000ml of solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Ltd., Cestrian Court,

Eastgate Way, Manor Park,

Runcorn, Cheshire, WA7 1NT, U.K.

Manufacturer

Aminoven in glass bottles is manufactured by:

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

A-8055 Graz

Austria

This leaflet was last revised in July 2017

Maximum infusion rate is 0.67ml of Aminoven 25 per kg body weight and hour (equivalent to 0.1g amino

acids per kg body weight and hour).

Maximum daily dose to adults

13.3ml of Aminoven 25 per kg body weight/day (equivalent to 2.0g amino acids per kg body weight) e.g.

corresponding to 140g amino acids at 70kg body weight.

Aminoven 25 is contraindicated in children.

The solution is administered as long as a parenteral nutrition is required.

Overdose (symtoms, emergency procedure, antidotes):

As with other amino acid solutions shivering, vomiting, nausea, and increased renal amino acid losses can

occur when Aminoven is given in overdose or the infusion rate is exceeded.

Infusion should be stopped immediately in this case. It may be possible to continue with a reduced dosage.

A too rapid infusion can cause fluid overload and electrolyte disturbances.

Emergency procedures should be general supportive measures, with particular attention to respiratory and

cardiovascular systems. Close biochemical monitoring would be essential and specific abnormalities treated

appropriately.

There is no specific antidote for overdose.

Storage

Keep out of the reach and sight of children.

Keep container in the outer carton. Do not store above 25

C. Do not freeze.Use only clear, particle-free

solutions and undamaged containers.

Do not use Aminoven after the expiry date which is stated on the label after Expiry Date. The expiry date

refers to the last day of that month.

Aminoven should be used with sterile transfer equipment immediately after opening. Any unused solution

should be discarded.

Aminoven may be aseptically admixed with other nutrients such as fat emulsions, carbohydrates and

electrolytes. Chemical and physical stability data for a number of admixtures stored at 4°C for up to 9 days

are available from the manufacturer upon request.

From a microbiological point of view, TPN admixtures compounded in uncontrolled or unvalidated conditions

should be used immediately. If not used immediately, in-use storage times and conditions prior to use are

the responsibility of the user and should normally be no longer than 24 hours at 2 to 8°C, unless mixing has

taken place in controlled and validated aseptic conditions.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Aminoven 8, solution for infusion, bottle

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1000 ml solution for infusion contain:

Isoleucine

2. 50

Leucine 3.

Lysine acetate

4. 655

= Lysine 3.30 g

Methionine

2. 15

Phenylalanine

2. 55

Threonine

2. 20

Tryptophan

1. 00

Valine

Arginine

6. 00

Histidine

1. 50

Alanine 7.

Glycine 5.

Proline

Serine

Tyrosine 0.

Taurine 0.

Total amino acids:

50.0 g/l

Total nitrogen:

8.1 g/l

Total energy:

840 kJ/l (= 200kcal/l)

Titratable acidity

12 mmol NaOH/l

3 PHARMACEUTICAL FORM

Solution for infusion

The solution is clear and colourless to slightly yellow

5.5 - 6.3

Theoretical osmolarity:

495 mosm/l

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

For supply of amino acids as part of a parenteral nutrition regimen.

Amino acid solutions should be administered generally in combination with adequate amount of energy supplements.

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4.2 Posology and method of administration

Posology

The daily requirement of amino acids depends on the body weight and the metabolic conditions of the patient.

The maximum daily dose varies with the clinical condition of the patient and may even change from day to day.

The recommended infusion period is to provide a continuous infusion for at least 14 hours up to 24 hours, depending

on the clinical situation. Bolus administration is not recommended.

The solution is administered as long as a parenteral nutrition is required.

Adults

Dosage:

16 - 20 ml of Aminoven 8 per kg body weight/day (equivalent to 0.8 - 1.0 g amino acids per kg body weight/day), e.g.

corresponding to 1120 - 1400 ml Aminoven 8 at 70 kg body weight/day.

Maximum infusion rate:

2.0 ml of Aminoven 8 per kg body weight/hour (equivalent to 0.1 g amino acids per kg body weight/hour).

Maximum daily dose:

20 ml of Aminoven 8 per kg body weight/day (equivalent to 1.0 g amino acids per kg body weight/day) corresponding

to 70 g amino acids at 70 kg body weight.

For an increased amino acids dosage suitable preparations are available.

Paediatric population

No studies have been performed in the paediatric population.

Aminoven 8 is contraindicated in children less than 2 year of age (see section 4.3). For children under 2 years,

paediatric amino acid preparations which are formulated to meet their different metabolic needs should be used.

Children and adolescents (2-18 years)

Dosage:

The dose should be adjusted to hydration status, biological development and body weight.

Maximum infusion rate:

Same as for adults, see information above.

Maximum daily dose:

40 ml of Aminoven 8 per kg body weight/day (equivalent to 2.0 g amino acids per kg body weight/day) but total daily

fluid intake must be considered.

Method of administration

For administration via a peripheral or central vein as a continuous infusion.

4.3 Contraindications

The administration of Aminoven 8 is contraindicated in children less than 2 years of age.

As for all amino acid solutions the administration of Aminoven 8 is contra-indicated in the following conditions:

Disturbances of amino acid metabolism, metabolic acidosis, renal insufficiency without

haemodialysis or haemofiltration treatment, advanced liver insufficiency, fluid overload, shock, hypoxia,

decompensated heart failure.

4.4 Special warnings and precautions for use

Serum electrolytes, fluid balance and renal function should be monitored.

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In cases of hypokalemia and/or hyponatremia adequate amounts of potassium and/or sodium should be supplied

simultaneously.

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

Care should be given if large volumes infused in patients with cardiac insufficiency.

Infusion via peripheral veins in general can cause irritation of the vein wall and thrombophlebitis. Therefore, daily

inspections of the insertion site are recommended.

If adjunction of lipid emulsions is indicated it should be administered where possible as a mixture with Aminoven 8 in

order to minimise the risk of vein irritation.

The choice of a peripheral or central vein depends on the final osmolarity of the mixture. The general accepted limit for

peripheral infusion is approx. 800 mosm/l, but it varies considerably with the age and the general condition of the

patient and the characteristics of the peripheral veins.

Strict asepsis should be maintained, particularly when inserting a central vein catheter.

Aminoven 8 is for use as part of total parenteral nutrition in combination with adequate amounts of energy supplements

(carbohydrate solutions, lipid emulsions), electrolytes, vitamins and trace elements.

4.5 Interaction with other medicinal products and other forms of interaction

No interactions are known to date.

Concerning incompatibilities, see Section 6.2.

4.6 Fertility, pregnancy and lactation

No specific studies have been performed to assess the safety of Aminoven 8 in fertility, pregnancy or lactation.

However, clinical experiences with similar parenteral amino acid solutions have shown no evidence of risk during

pregnancy or breastfeeding. The risk/benefit relationship should be considered before administering Aminoven 8

during pregnancy or breastfeeding.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

None known when correctly administered.

Undesirable effects which occur during overdose (see Section 4.9) are usually reversible and regress when therapy is

discontinued. Infusion via peripheral veins in general can cause irritation of the vein wall and thrombophlebitis.

No clinical studies have been conducted.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

As with other amino acid solutions shivering, vomiting, nausea, and increased renal amino acid losses can occur when

Aminoven 8 is given in overdose or the infusion rate is exceeded. Infusion should be stopped immediately in this case.

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It may be possible to continue with a reduced dosage.

A too rapid infusion can cause fluid overload and electrolyte disturbances.

There is no specific antidote for overdose. Emergency procedures should be supportive general measures, with

particular attention to respiratory and cardiovascular systems. Close biochemical monitoring is essential and specific

abnormalities should be treated appropriately.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Amino acids - solution for parenteral nutrition, ATC code: B05B A01

The amino acids contained in Aminoven 8 are all naturally occuring physiological compounds. As with the amino acids

derived from the ingestion and assimilation of food proteins, parenterally administered amino acids enter the body pool

of free amino acids and all subsequent metabolic pathways.

5.2 Pharmacokinetic properties

The amino acids in Aminoven 8 enter the plasma pool of corresponding free amino acids. From the intravascular space,

amino acids reach the interstitial fluid and the intracellular space of different tissues.

Plasma and intracellular free amino acid concentrations are endogenously regulated for each single amino acid within

narrow ranges, depending on the age, nutritional status and pathological condition of the patient.

Balanced amino acid solutions such as Aminoven 8 do not significantly alter the physiologicamino acid pool of

essential and non-essential amino acids when infused at a constant and slow infusion rate.

Characteristic changes in the physiologic plasma amino acid pool are only foreseeable when the regulative function of

essential organs as liver and kidneys is seriously impaired. In such cases special formulated amino acid solutions may

be recommended for restoring homeostasis.

Only a small proportion of the infused amino acids is eliminated by the kidneys.

For the majority of amino acids plasma half-lives between 10 and 30 minutes have been reported.

5.3 Preclinical safety data

Preclinical toxicity data are available for single amino acids but are not relevant to mixtures of amino acids in solutions

such as Aminoven 5%. No preclinical toxicity studies with Aminoven 8 have been carried out. Studies with comparable

amino acid solutions have shown no toxic effect.

Intravenous infusion of doses of Aminoven 8 were well tolerated in rabbits. Aminoven 8 administered in error by intra-

arterial infusion, paravenous, subcutaneous or intramuscular injection to rabbits caused histopathological changes (eg

oedema, haemorrhage, lymphohistiocytic infiltration) comparable to those seen in the control animals, but was

otherwise well tolerated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glacial acetic acid

Water for injections

6.2 Incompatibilities

Due to the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be

mixed with other medicinal products. Should it become necessary to add other nutrients, see sections 6.3 c), 6.4, 6.6.

6.3 Shelf life

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a)

Shelf-life of the medicinal product as packaged for sale

Glass bottle: 2 years

b)

Shelf life after first opening the container

Aminoven 5% should be used with sterile transfer equipment immediately after opening. Any unused solution

should be discarded.

c)

Shelf-life after mixing with other components

In general, TPN admixtures may be stored for a maximum period of 24 hours at 2 to 8°C, unless a longer storage

period has been proven. See Section 6.4.

6.4 Special precautions for storage

Keep container in the outer carton.

Do not freeze.

Storage precautions after mixing with other components:

Aminoven 8 may be aseptically admixed with other nutrients as lipid emulsions, carbohydrates and electrolytes.

Chemical and physical stability data for a number of admixtures stored at 4°C for up to 9 days are available from the

manufacturer upon request.

From a microbiological point of view, TPN admixtures compounded in uncontrolled or unvalidated conditions should

be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of

the user and should normally be no longer than 24 hours at 2°C to 8°C, unless mixing has taken place in controlled and

validated aseptic conditions.

6.5 Nature and contents of container

Glass bottles, 500 ml and 1000 ml.

Type II, colourless glass, rubber closure/aluminium cap and outer carton.

Bottle sizes: 10 x 500 ml glass bottle

6 x 1000 ml glass bottle

1 x 500 ml glass bottle (sample package).

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

To be used immediately after the container is opened.

For single use only.

Do not use Aminoven 8 after expiry date.

Use only clear, particle-free solutions and undamaged containers.

Discard unused solutions. Any admixture remaining after infusion must be discarded.

Due to the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be

mixed with other drugs. Should it become necessary to add other nutrients, like carbohydrates, lipid emulsions,

electrolytes, vitamins or trace elements to Aminoven 8 for complete parenteral nutrition, care should be given to aseptic

techniques, thorough mixing and, in particular, to compatibility.

Compatibility data are available from the manufacturer for a number of mixtures.

7 MARKETING AUTHORISATION HOLDER

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Fresenius Kabi Limited

Cestrian Court

Eastgate Way

Runcorn

Cheshire WA7 1NT

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA0566/002/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:

September 1999

Date of last renewal:

January 2009

10 DATE OF REVISION OF THE TEXT

January 2018

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