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.