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AMINOVEN 8

Active substance(s): ALANINE / ARGININE / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE ACETATE / METHIONINE / PHENYLALANINE / PROLINE / SERINE / TAURINE / THREONINE / TRYPTOPHAN / TYROSINE / VALINE / ALANINE / ARGININE / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE ACETATE / METHIONIN

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Product Name:
AMINOVEN 25 (15%)
Type of Packaging:
PIL
Material number:
M094180/05 GB
Pharma-Code (Laetus)
x
Dimension:
180 x 588 mm

Territory:

GB

BLACK
DIE CUT

Dosage:
6x1000ml
2-D-Matrix Code
M094180/05 GB
EAN
Code:
Font:

Colour:

1. Draft
13.07. 2016 09.06 Uhr
1. Correction 12.10. 2016 07.41 Uhr
2. Correction 03.02. 2017 12.00 Uhr

Antique Olive

Variable Data:

Operator: Christian Nagy +43(0) 34 52 72266-22

Smallest Size: 9 Pt.

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 in children
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

V004

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.

M094180/05 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)

Isoleucine
Leucine

Aminoven® 8
2.50
3.70

Aminoven® 16 Aminoven® 25
5.00
5.20
7.40
8.90

Lysine acetate

4.655

9.31

15.66

Methionine
Phenylalanine
Threonine
Tryptophan
Valine
Arginine
Histidine
Alanine
Glycine
Proline
Serine
Tyrosine
Taurine

2.15
2.55
2.20
1.00
3.10
6.00
1.50
7.00
5.50
5.60
3.25
0.20
0.50

4.30
5.10
4.40
2.00
6.20
12.00
3.00
14.00
11.00
11.20
6.50
0.40
1.00

3.80
5.50
8.60
1.60
5.50
20.00
7.30
25.00
18.50
17.00
9.60
0.40
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.
Aminoven 8 is also available in infusion bags which contain 500 ml of solution.
Aminoven 16 and Aminoven 25 are available in infusion bags which contain 500 ml or 1000 ml 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
Aminoven in infusion bags is manufactured by:
Fresenius Kabi AB Uppsala
Rapsgatan 7
S-751 74 Uppsala
Sweden
This leaflet was last revised in 10/2016

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 25oC. 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.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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