Aminoplasmal 5% Solution For Infusion
438/12260939/1014
Package leaflet: Information for the user
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 5% solution for infusion is and what it is used for
2. What you need to know before you use Aminoplasmal 5% solution for infusion
3. How to use Aminoplasmal 5% solution for infusion
4. Possible side effects
5. How to store Aminoplasmal 5% solution for infusion
6. Contents of the pack and other information
1. What Aminoplasmal 5% solution for infusion is and what it is used for
Aminoplasmal 5% 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 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. This solution can be given to adults, adolescents and chil-dren over 2 years.
Other medicines and Aminoplasmal 5% 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 5% 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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Dokument = 210 x 297 mm (DIN A4) 2 Seiten
2. What you need to know before you use Aminoplasmal 5% solution for infusion
Do not use Aminoplasmal 5% 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
• 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 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 5% 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 sodium, you will receive sufficient amounts of it.
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 5% 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 5% 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 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 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: 30 ml per kg of your body weight per day
5 - 13 years: 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 5% 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 5% 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_438
438/12260939/1014 GIF (PIL)
Standort Melsungen
Font size: 9 pt.
G 131054
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 5% 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
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.
The other ingredients are acetylcysteine, citric acid monohydrate (for pH-adjustment) and water for injections.
Electrolyte concentrations
Sodium
Potassium
Magnesium
Acetate
Chloride
Phosphate
Citrate
Amino acid content Nitrogen content
50 mmol/l 25 mmol/l 2.5 mmol/l 35 mmol/l 45 mmol/l 10 mmol/l 2.0 mmol/l 50 g/l 7.9 g/l
5. How to store Aminoplasmal 5% solution for infusion
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Energy
Osmolarity
Titration acidity (to pH 7.4), approximately pH
835 kJ/l A 200 kcal/l 592 mOsm/l 17 mmol/l 5.7 - 6.3
6. Contents of the pack and other information
What Aminoplasmal 5% solution for infusion contains
The active substances are amino acids and electrolytes.
This medicine contains:
What Aminoplasmal 5% solution for infusion looks like and contents of the pack
Aminoplasmal 5% 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.
Isoleucine
Leucine
Lysine hydrochloride (equivalent to lysine) Methionine Phenylalanine Threonine Tryptophan Valine Arginine Histidine Alanine Glycine Aspartic acid Glutamic acid Proline Serine Tyrosine Sodium acetate trihydrate Sodium chloride Sodium hydroxide Potassium acetate Magnesium chloride hexahydrate Disodium phosphate dodecahydrate
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per 1 ml |
per 250 ml |
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2.50 mg |
0.63 g |
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4.45 mg |
1.11 g |
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4.28 mg |
1.07 g |
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(3.43 mg) |
(0.86 g) |
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2.20 mg |
0.55 g |
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2.35 mg |
0.59 g |
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2.10 mg |
0.53 g |
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0.80 mg |
0.20 g |
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3.10 mg |
0.78 g |
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5.75 mg |
1.44 g |
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1.50 mg |
0.38 g |
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5.25 mg |
1.31 g |
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6.00 mg |
1.50 g |
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2.80 mg |
0.70 g |
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3.60 mg |
0.90 g |
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2.75 mg |
0.69 g |
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1.15 mg |
0.29 g |
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0.40 mg |
0.10 g |
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1.361 mg |
0.340 g |
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0.964 mg |
0.241 g |
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0.140 mg |
0.035 g |
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2.453 mg |
0.613 g |
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0.508 mg |
0.127 g |
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3.581 mg |
0.895 g |
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per 500 ml |
per 1000 ml |
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1.25 g |
2.50 g |
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2.23 g |
4.45 g |
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2.14 g |
4.28 g |
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(1.72 g) |
(3.43 g) |
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1.10 g |
2.20 g |
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1.18 g |
2.35 g |
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1.05 g |
2.10 g |
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0.40 g |
0.80 g |
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1.55 g |
3.10 g |
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2.88 g |
5.75 g |
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0.75 g |
1.50 g |
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2.63 g |
5.25 g |
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3.00 g |
6.00 g |
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1.40 g |
2.80 g |
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1.80 g |
3.60 g |
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1.38 g |
2.75 g |
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0.58 g |
1.15 g |
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0.20 g |
0.40 g |
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0.681 g |
1.361 g |
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0.482 g |
0.964 g |
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0.070 g |
0.140 g |
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1.227 g |
2.453 g |
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0.254 g |
0.508 g |
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1.791 g |
3.581 g |
Th is leaflet was last revised in September 2014.
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
Bulgaria
Czech Republic
Germany
Estonia
Greece
Hungary
Italy
Latvia
Netherlands Portugal Slovakia United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
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Aminoplasmal |
B. |
Braun |
5% |
E |
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Aminoplasmal |
B. |
Braun |
5% |
E |
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Aminoplasmal |
B. |
Braun |
5% |
E Infusionslosung |
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Aminoplasmal |
B. |
Braun |
5% |
E |
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Aminoplasmal |
B. |
Braun |
5% |
E 6iaAu|ja yia syxuori |
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Aminoplasmal |
B. |
Braun |
5% |
E, oldatos infuzio |
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Amielect 5%, |
sol |
uzione |
per |
infusione |
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Aminoplasmal |
B. |
Braun |
5% |
E, skldums infuzijam |
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Aminoplasmal |
B. |
Braun |
5% |
E, oplossing voor infusie |
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Aminoplasmal |
B. |
Braun |
5% |
E |
|
Aminoplasmal |
B. |
Braun |
5% |
E |
|
Aminoplasmal |
5% solution |
:or infusion | ||
The following information is intended for 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 content may have to be used in such situations.
Instructions for handling
Use a sterile giving set for infusion of Aminoplasmal 5% 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
12260939_Aminoplasmal_GIF-A4_GB_438.indd 2 17.10.14 08:54