Aminoplasmal B. Braun 10% E, oplossing voor infusie

Aminoplasmal B. Braun 10 % E is a solution which is given to you through a small tube with a cannula placed in a vein (intravenous infusion).

The solution is called a nutritional supplement. It contains amino acids and electrolytes that are essential for the body to grow or to recover.

You will receive this medicine if you are unable to eat food normally. When you receive this solution you will also receive others like glucose solutions or fat emulsions.

You will not receive Aminoplasmal B. Braun 10 % E

• if you are allergic (hypersensitive) to one of the ingredients included in Aminoplasmal B. Braun 10 % E (see section 6 for a full list of ingredients)
• 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
• if you have too high blood level of any of the electrolytes included in the solution.

This solution must not be administered to new-born babies and children under 2 years.

You should not receive any infusion 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)

Special care will be taken with Aminoplasmal B. Braun 10 % E

• if you suffer from an impairment of your metabolism of proteins and amino acids caused by any condi- tion other than mentioned above (see section “You will not receive …”).
• 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).

• Before and while you are receiving this solution, the doctor will check levels of fluids, electrolytes, blood sugar, serum proteins, acid base balance and your liver and kidney function.
• Usually you will receive Aminoplasmal B. Braun 10 % E as part of intravenous feeding which also in- cludes energy supplements (carbohydrate solutions, fat emulsions), vitamins, electrolytes and trace el- ements.
• The site of infusion will be checked daily for signs of inflammation or infection.

Taking or using other medicines

You should inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Your doctor will decide very carefully whether or not you should receive this solution in these situations.

Driving and using machines

Aminoplasmal B. Braun 10 % E 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.

Dosage

Adults and adolescents from 15 to 17 years

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

In general, this will be 10 ml to 20 ml per kg 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 14 years

In children the doctor will adjust the dosage carefully according to the individual child’s age, nutritional sta- tus and actual disease

The amounts to be given to children will be approximately:

• 3rd – 5th year: 15 ml per kg of your body weight per day
• 6th – 14th year: 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 B. Braun 10 % E may be used as long as you need intravenous feeding.

Method of administration

Aminoplasmal B. Braun 10% E will be administered to you by infusion into a large central vein.

If you receive more Aminoplasmal B. Braun 10 % E than you should

It is unlikely that this occurs 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 product, ask your doctor or pharmacist.

Like all medicines, Aminoplasmal B. Braun 10 % E can cause side effects, although not everybody gets them.

Side effects that may be observed are not specific for Aminoplasmal B. Braun 10% E but may occur during intravenous feeding, particularly at the beginning of the treatment.

Uncommon side effects (affects 1 to 10 treated patients of 1,000)

	Disorders of stomach and gut:	Vomiting, feeling sick
	General disorders:	Headache, shivering, fever

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Aminoplasmal B. Braun 10 % E after the expiry date which is stated on the label and the carton after “Exp.” The expiry date refers to the last day of that month.

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

What Aminoplasmal B. Braun 10 % E contains

The active substances are amino acids and electrolytes.

Per litre (1000ml) this medicine contains:
Isoleucine	5.00	g
Leucine	8.90	g
Lysine hydrochloride	8.56	g
(equivalent to lysine, 6.85 g)
Methionine	4.40	g
Phenylalanine	4.70	g
Threonine	4.20	g
Tryptophan	1.60	g
Valine	6.20	g
Arginine	11.50	g
Histidine	3.00	g
Alanine	10.50	g
Glycine	12.00	g
Aspartic acid	5.60	g
Glutamic acid	7.20	g
Proline	5.50	g
Serine	2.30	g
Tyrosine	0.40	g
Sodium acetate trihydrate	2.858	g
Sodium hydroxide	0.360	g
Potassium acetate	2.453	g
Magnesium chloride hexahydrate	0.508	g
Disodium phosphate dodecahydrate	3.581	g

The other ingredients are acetylcysteine, citric acid monohydrate and water for injections.

Electrolyte concentrations
Sodium	50 mmol/l
Potassium	25 mmol/l
Magnesium	2.5 mmol/l
Acetate	46 mmol/l
	3

Chloride	52 mmol/l
Phosphate	10 mmol/l
Citrate	2.0 mmol/l
Amino acid content	100	g/l
Nitrogen content	15.8 g/l
Energy	1675 kJ/l ≙ 400 kcal/l
Theoretical osmolarity	1021 mOsm/l
Titration acidity (to pH 7.4), approximately	26	mmol/l
pH	5.7 - 6.3

What Aminoplasmal B. Braun 10 % E looks like and contents of the pack

Aminoplasmal B. Braun 10 % E is a clear colourless or faintly straw-coloured solution.

The product comes in colourless glass bottles of 250 ml, 500 ml and 1000 ml, which are each closed by rub- ber 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-Straße 1

34209 Melsungen,

Duitsland

Phone: +49-5661-71-0

Fax: +49-5661-71-45 67

Fabrikant

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Duitsland

In het register ingeschreven onder

Aminoplasmal B. Braun 10 % E, oplossing voor infusie RVG: 113026

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

Austria	Aminoplasmal B. Braun 10% E Infusionslösung
Belgium	Aminoplasmal 16 E, oplossing voor infusie
Bulgaria	Aminoplasmal B. Braun 10 % E
Cyprus	Aminoplasmal B. Braun 10 % E
Denmark	Aminoplasmal Elektrolyt
Estonia	Aminoplasmal B. Braun 10% E
Germany	Aminoplasmal B. Braun 10% E Infusionslösung
Greece	Aminoplasmal B. Braun 10% E, διάλυμα για έγχυση
Hungary	Aminoplasmal B. Braun 10% E, oldatos infúzió
Italy	Amielect 10%, soluzione per infusione
Latvia	Aminoplasmal B. Braun 10% E, šķīdums infūzijām
Lithuania	Aminoplasmal B. Braun 10% E infuzinis tirpalas
Luxembourg	Aminoplasmal B. Braun 10% E Infusionslösung
Netherlands	Aminoplasmal B. Braun 10 % E, oplossing voor infusie
	4

Poland	Aminoplasmal B. Braun 10%	E, roztwór do infuzji
Portugal	Aminoplasmal B. Braun 10%	E
Romania	Aminoplasmal 100 g/l cu electroliţi soluţie perfuzabilă
Slovakia	Aminoplasmal B. Braun 10%	E
Slovenia	Amixal z elektroliti 100 mg/ml raztopina za infundiranje
Spain	Aminoplasmal B. Braun 10%	E solución para perfusión

Deze bijsluiter is voor het laatst goedgekeurd in juni 2013

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THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:

Instructions for handling

Use a sterile giving set for infusion of Aminoplasmal B. Braun 10% E.

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 asep- tic 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 homo- geneity.

Storage 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.