Auteur: B. Braun


Lange informatie

Waarvoor wordt dit middel gebruikt?

Aminoplasmal B. Braun 5 % 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 solution if you cannot eat food normally. When you receive this solution you will also receive others like glucose solutions or fat emulsions.

Inhoudsopgave
Wanneer mag u dit middel niet gebruiken of moet u er extra voorzichtig mee zijn?
Hoe gebruikt u dit middel?
Mogelijke bijwerkingen?
Hoe bewaart u dit middel?

Wanneer mag u dit middel niet gebruiken of moet u er extra voorzichtig mee zijn?

You will not receive Aminoplasmal B. Braun 5 % E

  • if you are allergic (hypersensitive) to any of the ingredients included in the solution (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 levels 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 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).

Special care will be taken with Aminoplasmal B. Braun 5 % E

  • if you suffer from an impairment of your metabolism of proteins and amino acids caused by any condition 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 5 % E 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.

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 or using machines

Aminoplasmal B. Braun 5 % E is normally given to immobile patients in a controlled setting (emergency treat- ment, acute treatment in a hospital or a day therapy unit). This will exclude driving and using machines.

Hoe gebruikt u dit middel?

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 20 – 40 ml per kg of your body weight per day. The solution will run in at a rate of not more than 2 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 status and actual disease.

The amounts to be given to children will be approximately: 3rd – 5th year: 30 ml per kg of your body weight per day 6th – 14th year: 20 ml per kg of your body weight per day

The solution will run in at a rate of not more than 2 ml per kg of your body weight per hour.

Duration of use

Aminoplasmal B. Braun 5 % E 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 B. Braun 5 % E 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 product, ask your doctor or pharmacist.

Mogelijke bijwerkingen?

Like all medicines, Aminoplasmal B. Braun 5 % E can have side effects although not everybody gets them.

Such side effects are not specifically related to the solution Aminoplasmal B. Braun 5 % E but may occur with any kind of intravenous feeding, especially at the beginning.

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

Hoe bewaart u dit middel?

Keep out of the reach and sight of children.

Do not use Aminoplasmal B. Braun 5 % E after the expiry date 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. FURTHER INFORMATION    
What Aminoplasmal B. Braun 5 % E contains    
The active substances are amino acids and electrolytes.    
Per litre (1000 ml) this medicine contains:    
Isoleucine 2.50 g
Leucine 4.45 g
Lysine hydrochloride 4.28 g
(equivalent to lysine, 3.43 g)    
Methionine 2.20 g
Phenylalanine 2.35 g
Threonine 2.10 g
Tryptophan 0.80 g
Valine 3.10 g
Arginine 5.75 g
Histidine 1.50 g
Alanine 5.25 g
Glycine 6.00 g
Aspartic acid 2.80 g
Glutamic acid 3.60 g
Proline 2.75 g
Serine 1.15 g
Tyrosine 0.40 g
Sodium acetate trihydrate 1.361 g
Sodium chloride 0.964 g
Sodium hydroxide 0.140 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 35 mmol/l
Chloride 45 mmol/l
Phosphate 10 mmol/l
Citrate 2.0 mmol/l
Amino acid content 50 g/l
Nitrogen content 7.9 g/l
Energy 835 kJ/l ≙ 200 kcal/l
Osmolarity 588 mOsm/l
Titration acidity (to pH 7.4), approximately 17 mmol/l
pH 5.7 – 6.3  

What Aminoplasmal B. Braun 5 % E looks like and contents of the pack

Aminoplasmal B. Braun 5 % 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 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-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 5 % E, oplossing voor infusie RVG: 113024

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

Austria Aminoplasmal B. Braun 5% E Infusionslösung
Bulgaria Aminoplasmal B. Braun 5 % E
Czech Republic Aminoplasmal B. Braun 5% E
Germany Aminoplasmal B. Braun 5% E Infusionslösung
Estonia Aminoplasmal B. Braun 5% E
Greece Aminoplasmal B. Braun 5% E διάλυμα για έγχυση
Hungary Aminoplasmal B. Braun 5% E, oldatos infúzió
Italy Amielect 5%, soluzione per infusione
Luxembourg Aminoplasmal B. Braun 5% E Infusionslösung
Latvia Aminoplasmal B. Braun 5% E, šķīdums infūzijām
Netherlands Aminoplasmal B. Braun 5 % E, oplossing voor infusie
Portugal Aminoplasmal B. Braun 5% E
Slovakia Aminoplasmal B. Braun 5% E

United Kingdom B. Braun Aminoplasmal 5% E solution for infusion

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 :

Dosage

In the case of amino acid requirements of 1 g per kg body weight per day or more, particular attention should be paid to the limitations of fluid input. To avoid fluid overload, amino acid solutions with higher amino acid con- tent may have to be used in such situations.

Instructions for handling

Use a sterile giving set for infusion of Aminoplasmal B. Braun 5 % 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 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 dis- solved by gentle warming at 25 °C until dissolution is complete. Shake container gently to ensure homogeneity.

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 con- trolled and validated aseptic conditions.

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