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Aminoplasmal 10% Solution For Infusion

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451/12260941/1014

Package leaflet: Information for the user

S Aminoplasmal 10% solution for infusion

Amino acids


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 pharmacist.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.


What is in this leaflet

1.    What Aminoplasmal 10% solution for infusion is and what it is used for

2.    What you need to know before you use Aminoplasmal 10% solution for infusion

3.    How to use Aminoplasmal 10% solution for infusion

4.    Possible side effects

5.    How to store Aminoplasmal 10% solution for infusion

6.    Contents of the pack and other information


1. What Aminoplasmal 10% solution for infusion is and what it is used for

Aminoplasmal 10% solution for infusion is a solution which is given to you through a small tube with a cannula placed in a vein (intravenous infusion). The solution contains amino acids that are essential for the body to grow or to recover.

You will receive this solution if you cannot eat food normally. When you receive this solution you will also receive others like glucose solutions or fat emulsions. This solution can be given to adults, adolescents and children over 2 years.


Other medicines and Aminoplasmal 10% solution for infusion

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Aminoplasmal 10% solution for infusion is normally given to immobile patients in a controlled setting (emergency treatment, acute treatment in a hospital or a day therapy unit). This will exclude driving and using machines.


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2. What you need to know before you use Aminoplasmal 10% solution for infusion
Do not use Aminoplasmal 10% solution for infusion

•    if you are allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6)

•    if you suffer from a genetic abnormality of your metabolism of proteins and amino acids

•    if you have a severe (i.e. life-threatening) circulation disorder (shock)

•    if you have insufficient oxygen supply

•    if acidic substances accumulate in your blood (acidosis)

•    if you have a severe liver disease

•    if you have kidney failure not adequately treated by artificial kidney.

This solution must not be administered to new-born babies and children under 2 years because the composition of the solution does not properly meet the special nutrition requirements of this age group..

You should not receive any infusions if you have:

•    poorly controlled heart failure with marked impairment of your blood circulation

•    accumulation of fluid in your lungs (lung oedema)

•    excess water in your body, swelling of limbs (hyperhydration).

Warnings and precautions

Talk to your doctor or pharmacist before using Aminoplasmal 10% solution for infusion

•    if you suffer from an impairment of your metabolism of proteins and amino acids caused by any condition other than mentioned above (see section "Do not use ...").

•    if you have an impairment of your liver or kidney function.

•    if you have an impairment of your heart function.

•    if you have abnormally high concentrated blood serum (high serum osmolarity).

If you are lacking water and salts at the same time, you will first receive sufficient amounts of these in order to correct that disorder. If you are lacking potassium or sodium, you will receive sufficient amounts of these. Before and while you are receiving this solution, your doctor will check levels of your fluids, electrolytes, blood sugar, serum proteins, acid base balance and your liver and kidney function.

Usually you will receive Aminoplasmal 10% solution for infusion as part of intravenous feeding which also includes energy supplements (carbohydrate solutions, fat emulsions), vitamins, electrolytes and trace elements. The site of infusion will be checked daily for signs of inflammation or infection.


3. How to use Aminoplasmal 10% solution for infusion

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

Adults and adolescents from 14 to 17 years

Your doctor will determine the amount of solution you need each day.

In general, this will be 10 - 20 ml per kg of your body weight per day. The solution will run in at a rate of not more than 1 ml per kg of your body weight per hour.

Children from 2 to 13 years

In children the doctor will adjust the dosage carefully according to the individual child's age, nutritional status and actual disease.

The amounts to be given to children will be approximately:

2 - 4 years:    15 ml per kg of your body weight per day

5 - 13 years: 10 ml per kg of your body weight per day The solution will run in at a rate of not more than 1 ml per kg of your body weight per hour.

Duration of use

Aminoplasmal 10% solution for infusion may be used as long as you need intravenous feeding.

Method of administration

The solution will be administered to you through a small plastic tube inserted into one of your large veins.

If you receive more Aminoplasmal 10% solution for infusion than you should

It is unlikely that this will occur because your doctor will determine your daily doses. However, if you receive an overdose or the solution is running in too fast, you will lose part of the amino acids in urine, you may feel sick or vomit or you may shiver. If this happens, the infusion will be stopped temporarily and resumed later on at a lower infusion rate.

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


GB_451

451/12260941/1014 GIF (PIL)

Standort Melsungen Font size: 9 pt.

G 131053


4. Possible side effects

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

Such side effects are not specifically related to the solution Aminoplasmal 10% solution for infusion but may occur with any kind of intravenous feeding, especially at the beginning.

The following side effects may be serious. If any of the following side effects occur, tell your doctor immediately, he will stop giving you this medicine:

Not known (frequency cannot be estimated from the available data)

• Allergic reactions


BlBRAUN


28 mmol/l 2.0 mmol/l

100 g/l 15.8 g/l

1675 kJ/l A 400 kcal/l 864 mOsm/l 20 mmol/l 5.7 - 6.3


Other side effects

Uncommon (may affect up to 1 in 100 people)

•    Vomiting, feeling sick

•    Headache

•    Shivering

•    Fever

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist 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

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

5.    How to store Aminoplasmal 10% solution for infusion

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and carton labels. The expiry date refers to the last day of that month.

Keep bottles in the outer carton in order to protect from light. Do not freeze. After infusion, any remaining solution should never be stored for later use.

6.    Contents of the pack and other information
What Aminoplasmal 10% solution for infusion contains

The active substances are amino acids.

Electrolyte concentrations

Acetate

Citrate

Amino acid content Nitrogen content

Energy Osmolarity

Titration acidity (to pH 7.4), approximately pH

What Aminoplasmal 10% solution for infusion looks like and contents of the pack

Aminoplasmal 10% solution for infusion is a clear, colourless up to faintly straw-coloured solution.

The product comes in colourless glass bottles of 250 ml, 500 ml and 1000 ml, which are each closed by rubber stoppers.

The 250 ml and 500 ml bottles are available in packs of 10. The 1000 ml bottles are available in packs of 6.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

B. Braun Melsungen AG

Carl-Braun-StraBe 1, 34212 Melsungen, Germany

Postal address

34209 Melsungen, Germany

Phone: +49-5661-71-0

Fax:    +49-5661-71-45 67

This medicine contains: Isoleucine

per 1 ml 5.00 mg

per 250 ml 1.25 g

per 500 ml 2.50 g

per 1000 ml 5.00 g

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

Leucine

8.90 mg

2.23 g

4.45 g

8.90 g

Austria

Aminoplasmal B. Braun 10 % Infusionslosung

Lysine acetate

5.74 mg

1.44 g

2.87 g

5.74 g

Belgium

Aminoplasmal 16, oplossing voor infusie

(equivalent to lysine)

(4.07 mg)

(1.02 g)

(2.04 g)

(4.07 g)

Czech Republic

Aminoplasmal B. Braun 10 %

Lysine monohydrate

3.12 mg

0.78 g

1.56 g

3.12 g

Denmark

Aminoplasmal

(equivalent to lysine)

(2.78 mg)

(0.70 g)

(1.39 g)

(2.78 g)

Germany

Aminoplasmal B. Braun 10 % Infusionslosung

Methionine

4.40 mg

1.10 g

2.20 g

4.40 g

Estonia

Aminoplasmal B. Braun 10 %

Phenylalanine

4.70 mg

1.18 g

2.35 g

4.70 g

Spain

Aminoplasmal B. Braun 10 % solucion para perfusion

Threonine

4.20 mg

1.05 g

2.10 g

4.20 g

Finland

Aminoplasmal 16 N/l infuusioneste, liuos

Tryptophan

1.60 mg

0.40 g

0.80 g

1.60 g

Hungary

Aminoplasmal B. Braun 10 %, oldatos inf'uzio

Valine

6.20 mg

1.55 g

3.10 g

6.20 g

Italy

Amixal 10 %, soluzione per infusione

Arginine

11.50 mg

2.88 g

5.75 g

11.50 g

Lithuania

Aminoplasmal B. Braun 10 % infuzinis tirpalas

Histidine

3.00 mg

0.75 g

1.50 g

3.00 g

Latvia

Aminoplasmal B. Braun 10 % skldums infuzijam

Alanine

10.50 mg

2.63 g

5.25 g

10.50 g

Netherlands

Aminoplasmal B. Braun 10 % E-vrij, oplossing voor infusie

Glycine

12.00 mg

3.00 g

6.00 g

12.00 g

Poland

Aminoplasmal B. Braun 10 %

Aspartic acid

5.60 mg

1.40 g

2.80 g

5.60 g

Portugal

Aminoplasmal B. Braun 10 %

Glutamic acid

7.20 mg

1.80 g

3.60 g

7.20 g

Slovakia

Aminoplasmal B. Braun 10 %

Proline

5.50 mg

1.38 g

2.75 g

5.50 g

Slovenia

Amixal 100 mg/ml raztopina za infundiranje

Serine

2.30 mg

0.58 g

1.15 g

2.30 g

United Kingdom

Aminoplasmal 10% solution for infusion

Tyrosine

0.40 mg

0.10 g

0.20 g

0.40 g

The other ingredients a adjustment) and water

re acetylcysteine, citric acid monohydrate (for pH- This leaflet was last revised in September 2014. for injections.

The following information is intended for healthcare professionals only:

Instructions for handling

Use a sterile giving set for infusion of Aminoplasmal 10% solution for infusion.

If in the setting of complete parenteral nutrition it is necessary to add other nutrients such as carbohydrates, lipids, vitamins and trace elements to this medicinal product, admixing must be performed under strict aseptic conditions. Mix well after admixture of any additive. Pay special attention to compatibility.

Special precaution for storage

The product must not be used if the solution is not clear or the container or its closure are damaged.

Cool storage of the solution, below 15 °C, may lead to formation of crystals, that can, however, be easily dissolved by gentle warming at 25 °C until dissolution is complete. Shake container gently to ensure homogeneity.

Shelf life after mixing with other components

From the microbiological point of view, mixtures should be administered immediately after preparation. If not administered immediately, storage times and conditions of mixtures prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless mixing has taken place under controlled and validated aseptic conditions.

B. Braun Melsungen AG

34209 Melsungen, Germany

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