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AMINOPLASMAL PAEDIATRIC 10% SOLUTION FOR INFUSION

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE MONOHYDRATE / METHIONINE / PHENYLALANINE / PROLINE / SERINE / TAURINE / THREONINE / TRYPTOPHAN / VALINE

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488/12614903/1115

Package leaflet: Information for the patient

Aminoplasmal Paediatric 10%
solution for infusion
For use in children (0-11 years old)
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 or nurse.
• This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illnessare the same as your
child’s.
• If your child gets any side effects , talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Aminoplasmal Paediatric 10% is and what it is used for
2. What you need to know before your child receives Aminoplasmal
Paediatric 10%
3. How to use Aminoplasmal Paediatric 10%
4. Possible side effects
5. How to store Aminoplasmal Paediatric 10%
6. Contents of the pack and other information

1. What Aminoplasmal Paediatric 10% is and what it is
used for
Aminoplasmal Paediatric 10% contains amino acids that are essential
for the body to grow or to recover. The solution is adapted to meet the
specific needs of preterm and term newborn infants, infants and toddlers
and children. They will receive this solution as part of intravenous feeding
if they cannot eat food normally. They may also receive other nutrients
like glucose solutions or fat emulsions in combination with Aminoplasmal
Paediatric 10%.

2. What you need to know before your child receives
Aminoplasmal Paediatric 10 %
Do not use Aminoplasmal Paediatric 10%, if your child
• is allergic to active substances or any of the other ingredients of this
medicine (listed in section 6)
• has inborn disorders of its protein and/or amino acid metabolism
• has a life-threatening circulatory condition (shock)
• has abnormally low levels of potassium
• has acidic substances that accumulate in blood (acidosis)
• has a severe heart weakness with impaired circulation (decompensated
cardiac insufficiency)
• has an insufficient oxygen supply
• has excess body water, swelling of limbs (hyperhydration).
• an accumulation of fluid in lungs (lung oedema)
Your doctor will also take into account that amino acid containing
solutions in general must not be used if your child
• suffers from a severe liver disease (severe hepatic insuffiency)
• suffers from a severe kidney failure (severe renal insufficiency) not
treated with renal replacement therapy
• is in a state of coma as a result of a severe liver failure (hepatic coma)

Warnings and precautions
Talk to your doctor or nurse before you use Aminoplasmal Paediatric
10%, if your child
• suffers from an impairment of metabolism of protein and/or amino
acids caused by any condition other than an inborn metabolism
disorder (see section “Do not use Aminoplassmal Paediatric 10% if your
child…”).
• suffers from an impairment ofliver and/or kidney function
• has a high concentrated blood serum (high serum osmolarity)
• needs to restrict intake of the fluids
Additional precautions taken by your doctor
Before and while children are receiving this solution, the doctor will
check levels of fluids, blood chemistry and other blood levels, liver and
kidney function.
Usually children will receive Aminoplasmal Paediatric 10% as part of
intravenous feeding which also includes energy supplements (glucose
solutions, fat emulsions), vitamins, electrolytes and trace elements.

6. Contents of the pack and other information

Format = 210 x 594 mm
2 Seiten

What Aminoplasmal Paediatric 10% contains

Lätus 303

The active substances are
Amino acids
Isoleucine
Leucine
Lysine monohydrate
(equivalent to lysine)
Methionine
Phenylalanine
Threonine
Tryptophan
Valine
Arginine
Histidine
Alanine
Glycine
Aspartic acid
Glutamic acid
Proline
Serine
N-Acetyltyrosine
(equivalent to tyrosine)
Acetylcysteine
(equivalent to cysteine)
Taurine
Amino acid content
Nitrogen content

per 1 ml
5.10 mg
7.60 mg
9.88 mg
(8.80 mg)
2.00 mg
3.10 mg
5.10 mg
4.00 mg
6.10 mg
9.10 mg
4.60 mg
15.90 mg
2.00 mg
6.60 mg
9.30 mg
6.10 mg
2.00 mg
1.30 mg
(1.06 mg)
0.700 mg
(0.520 mg)
0.300 mg

per 100 ml
0.51 g
0.76 g
0.99 g
(0.88 g)
0.20 g
0.31 g
0.51 g
0.40 g
0.61 g
0.91 g
0.46 g
1.59 g
0.20 g
0.66 g
0.93 g
0.61 g
0.20 g
0.13 g
(0.11 g)
0.070 g
(0.052 g)
0.030 g

per 250 ml
1.28 g
1.90 g
2.47 g
(2.20 g)
0.50 g
0.78 g
1.28 g
1.00 g
1.53 g
2.28 g
1.15 g
3.98 g
0.50 g
1.65 g
2.33 g
1.53 g
0.50 g
0.33 g
(0.27 g)
0.175 g
(0.13 g)
0.075 g

per 1 ml
0.1 g
0.0152 g

per 100 ml
10 g
1.52 g

per 250 ml
25 g
3.8 g

Energy [kJ/l (kcal/l)]
Theoretical osmolarity [mOsm/l]
Acidity (titration to pH 7.4)
pH

1700  (400)
790 
23 mmol
approx. 6.1

The other ingredients are citric acid monohydrate (for pH-adjustment)
and water for injection.

What Aminoplasmal Paediatric 10% looks like and contents
of the pack
Aminoplasmal Paediatric 10% is a clear, colourless up to light yellow
solution.
It is supplied in flexible bags containing 100 ml or 250 ml of amino acids
solution. The bags are made of multilayer foil. The inner layer in contact
with the solution consists of polypropylene.
Container is PVC-free, DEHP-free, latex-free.
The bag is packed in a protective plastic bag. An oxygen absorber
(containing powdered iron hydroxide) is placed between bag and
overwrap.
The different container sizes are presented in cartons containing 12 bags.
Pack sizes: 12 x 100 ml and 12 x 250 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Other medicines and Aminoplasmal Paediatric 10%

B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany

Tell your doctor, if your child is taking, has recently taken or might take
any other medicines.

Phone: +49/5661/71-0
Fax: +49/5661/71-4567

Pregnancy and breast-feeding
Ask your doctor for advice before you receive this medicine.

This medicinal product is authorised in the Member States of
the EEA under the following names:

Aminoplasmal Paediatric 10% is intended for use in children (under
twelve years old) only.

Austria
Belgium

Driving and using machines
Not relevant

3. How to use Aminoplasmal Paediatric 10%
Aminoplasmal Paediatric 10% is given by health care professionals.
The doctor will decide how much of this medicine is needed and for how
long this medicine will be given to children.
The solution will be given through a small plastic tube inserted into a
vein.

If your child receives more Aminoplasmal Paediatric 10% than
it should
If this medicine is given too rapidly, it may not be tolerated well. Then
your child may feel sick, may have to vomit or a redening of the face and
sensations of warmth might be seen. Your child may also lose amino acids
in the urine and as a result from that, shifts in the proportion of amino
acids in its blood may occur.
In case of an overdose your doctor will give your child any necessary
treatment.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following side effects are not specifically related to the solution
Aminoplasmal Paediatric 10 % but may occur with any kind of intravenous
feeding, especially at the beginning of therapy.
Uncommon (may affect up to 1 in 100 people):
• feeling sick, vomiting
• headache
• shivering
• fever
Vein inflammation plus blood clotting (thrombophlebitis) may occur when
the product is not sufficiently diluted and given through a peripheral
vein.

Reporting of side effects
If your child gets any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.

Postal address:
34209 Melsungen, Germany

Aminoplasmal Paed 10% Infusionslösung
Aminoplasmal Paediatric oplossing voor infusie/solution
pour perfusion/Infusionslösung
Bulgaria
Aminoplasmal Paed 10%
Czech Republic Amiped
Denmark
Amiped
Finland
Amiped
Germany
Aminoplasmal Paed 10% Infusionslösung
Greece
Aminoplasmal Paed 10%
Hungary
Aminoplasmal Paed 10% Oldatos infúzió
Italy
Amiped
Luxembourg
Aminoplasmal Paed 10%
Netherlands
Aminoplasmal Paed 100 mg/ml, oplossing voor infusie
Norway
Amiped
Poland
Aminoplasmal Paed 10%
Portugal
Aminoplasmal Paed
Slovak Republic Amiped
Slovenia
Aminoplasmal Paed 100 mg/ml raztopina za infundiranje
Sweden
Amiped
United Kingdom Aminoplasmal Paediatric 10% solution for infusion

This leaflet was last revised in September 2015.

The following information is intended for healthcare
professionals only.
Posology
Paediatric population
The dosages for these age groups as stated below are average values for
guidance. The exact dosage should be adjusted individually according to
age, developmental stage, prevailing disease and type of therapy.
Dosing should be commenced below target infusion rate value and be
increased to target value within the first hour.
Parenteral amino acid supply considered adequate for most paediatric
patients:
Preterm infants:
1.5 - 4.0 g amino acids/kg body weight per day = 15 - 40 ml /kg b. w./d
Term newborn infants (0 – 27 days):
1.5 - 3.0 g /kg b. w./d = 15 - 30 ml/kg b. w./d
Infants and toddlers (28 days to 23 months):
1.0 - 2.5 g /kg b. w./d = 10 - 25 ml/kg b. w./d

By reporting side effects you can help provide more information on the
safety of this medicine.

Children (2 to 11 years): 1.0 - 2.0 g/kg b. w./d = 10 - 20ml/kg b. w./d
For critically ill children the advisable amino acid intake may be higher
(up to 3.0 g amino acids/kg body weight per day).

5. How to store Aminoplasmal Paediatric 10%

Maximum rate of infusion up to 0.1 g amino acids/kg body weight and
hour, corresponding approximately 1 ml/kg body weight and hour

Keep this medicine out of the sight and reach of children.
Do not freeze. Do not use if accidentally frozen and dispose of the bag.
Do not use this medicine after the expiry date that is stated on the label
after EXP.

Special precautions for disposal and other handling
Do not use if overwrap has been previously opened or damaged. Only use
bags that are undamaged and in which the amino acid solution is clear
and free of particles.

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schwarz

18.11.15 08:11

GB___488
488/12614903/1115
GIF (Monobag)
Standort Melsungen (LIFE N)

Font size: 9,0 pt.

488/12614903/1115

Aminoplasmal Paediatric 10% is supplied in single use containers. Unused
residues must be discarded.
The solution should always be brought to room temperature prior to
infusion.
It is essential that any admixture be prepared using strict aseptic
techniques as this nutrient mixture supports microbial growth.
Aminoplasmal Paediatric 10% should be used immediately after opening
the container.

Aminoplasmal Paediatric 10%: Handling
Figure A: Bag and Overwrap

Tear Notches

To Add Medication:
Admixtures must be prepared following strict aseptic techniques .
Compatible supplemental medication may be added through the
medication port (transparent colour).
1. Prepare medication port (transparent colour) by removal of aluminum
foil (figure 2a). Please note: The area underneath the foil of the
medication port is sterile.
2. Puncture resealable medication port and inject additive(s) (figure 2b).
3. Mix solution and medication thoroughly (figure 3a).
4. Medication port may be swabbed with disinfection agent (e.g. isopropanol) before re-puncturing.
5. Check admixture visually for particulate matter (figure 3b).

Overwrap

2a

2b

3a

3b

Oxygen Absorber
Figure B: Bag

Bag Hanger

Infusion Port

Medication Port

To Open:
Remove the bag from its protective overwrap starting from the tear
notches on top and remove solution container (figure 1).
Discard overwrap and oxygen absorber.
Check for leakages. If bag leaks, discard product as sterility may be
impaired.

Preparation for Administration:
1. Remove aluminum foil of infusion port (green colour) at the bottom
of container (figure 4a) and attach administration set (figure 4b):
use non-vented infusion set or close air vent on a vented set. Follow
directions for use of the infusion set. Please note: The area underneath
the foil of the infusion port is sterile.
2. Hang bag on an i.v. pole (figure 5).

4a

4b

1

5

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B. Braun Melsungen AG
34209 Melsungen, Germany

18.11.15 08:11

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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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