Auteur: B. Braun


Lange informatie

Waarvoor wordt dit middel gebruikt?

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.

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?
Anvullende Informatie

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

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.

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 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.

Mogelijke bijwerkingen?

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.

Hoe bewaart u dit middel?

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.

Anvullende Informatie

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.

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