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AMINOVEN 16

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

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M094601/00 GB

Aminoven 8 (5%)
Size
420 x 148 mm 2 Seiten
Pharmacode 8918
EAN-Code:
Smallest Font Size 8 Pt.
1. Entwurf
Christian Nagy

25.09.2014 | 07:15 uhr
+43(0)3452/72266-22

M094601/00 GB
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.

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
Isoleucine
Leucine
Lysine acetate
Methionine
Phenylalanine
Threonine
Tryptophan
Valine
Arginine
Histidine
Alanine
Glycine
Proline
Serine
Tyrosine
Taurine

Quantity (g)
Aminoven® 8 Aminoven® 16
2.50
5.00
3.70
7.40
4.655
9.31
2.15
4.30
2.55
5.10
2.20
4.40
1.00
2.00
3.10
6.20
6.00
12.00
1.50
3.00
7.00
14.00
5.50
11.00
5.60
11.20
3.25
6.50
0.20
0.40
0.50
1.00

Aminoven 8 and Aminoven 16 also contain glacial acetic acid and
water for injections.
V002

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 8 is also available in infusion bags which contain 500 ml
of solution.
Aminoven 16 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 09/2014

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aminoven® 8 Solution for Infusion
Aminoven® 16 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 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 2 products:

• Aminoven 8 Solution for Infusion
• Aminoven 16 Solution for Infusion
In this leaflet the two 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 5% and 10% should not be used for children
below 2 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)
V002

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 also
report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of
this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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.

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 5% 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.

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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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