Patient leaflet - Aminoplasmal 10% solution for infusion
1. What Aminoplasmal 10% is and what it is used for
Aminoplasmal 10% 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 that are essential for the body to grow or to recover.
You will receive this medicine if you are unable to eat food normally and you cannot be fed through a tube placed into your stomach either. This solution can be given to adults, adolescents and children over 2 years of age.
2. What you need to know before you use Aminoplasmal
10%
Do not use Aminoplasmal 10%
- 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 an inborn error 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 (hypoxia)
- if acidic substances accumulate in your blood (metabolic acidosis)
- if you have a severe liver disease (severe hepatic insufficiency or decompensated liver cirrhosis with hepatic encephalopathy grades III and IV)
- if you have severe kidney failure (severe renal insufficiency) not adequately treated by artificial kidney or similar therapies
- if you suffer from a poorly controlled heart failure with marked impairment of your blood circulation (decompensated cardiac insufficiency)
- if you have accumulation of fluid in your lungs (acute pulmonary oedema)
- if your body’s salt (electrolyte) or water balance is disturbed
This solution must not be given to newborn babies, infants and toddlers less than two years of age because the composition of the solution does not properly meet the special nutrition requirements of this age group.
Warnings and precautions
Talk to your doctor or pharmacist before using Aminoplasmal 10%
- 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 mild to moderate impairment of your liver or decompensated liver cirrhosis with hepatic encephalopathy (grades I and II) or kidney function
- if you have an impairment of your heart function
- if you have abnormally high concentrated blood serum (high serum osmolarity)
If your body’s water or salt balance is disturbed, this condition should be corrected before you receive this medicine. Examples for this condition are a lack of water and salts at the same time (hypotonic dehydration) or a lack of sodium (hyponatraemia) or potassium (hypokalaemia).
Before and while you are receiving this medicine, your blood salt levels, blood sugar levels, the water balance, the acid-base balance, your blood proteins and kidney and liver function will be monitored. For this purpose blood samples will be taken and your urine will be collected and both will be analysed.
Usually you will receive Aminoplasmal 10% as part of intravenous feeding which also includes non-protein energy supplements (carbohydrate solutions, fat emulsions), essential fatty acids, electrolytes, vitamins, fluids and trace elements.
Other medicines and Aminoplasmal 10%
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.
Pregnancy
If you are pregnant, you will receive this medicine only if the doctor considers it necessary for your recovery. There are no data available about the use of this medicine in pregnant women.
Breast-feeding
At therapeutic doses of Aminoplasmal 10% no effects on the breastfed newborn/infant are anticipated. Nevertheless, breast-feeding is not recommended if women need intravenous feeding at the same time.
Driving and using machines
This medicine 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.
3. How to use Aminoplasmal 10%
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
Your doctor will determine the amount of solution you need each day. In general, this will be 10 – 20 ml per kg of your body weight per day. The solution will flow in at a rate of not more than 1 ml per kg of your body weight per hour.
Children from 2 to 18 years old
In children the doctor will adjust the dosage carefully according to the individual child’s age, status of development and actual disease. The amounts to be given will be:
2 to less than 3 years old: 10 - 25 ml per kg of body weight per day 3 to 18 years old: 10 - 20 ml per kg of body weight per day For critically ill children the amount to be given may be higher (up to 30 ml per kg body weight per day).
The solution will run in at a rate of not more than 1 ml per kg body weight per hour.
Patients with kidney or liver disease
The doses will be adjusted according to your individual requirements if you have liver (mild to moderate hepatic insufficiency or decompensated liver cirrhosis with hepatic encephalopathy grades I and II) or kidney disease. When given during dialysis amino acid losses into the dialysate have to be considered.
Duration of use
This medicine may be used as long as you need intravenous feeding.
Method of administration
This medicine will be administered to you through a small tube inserted into one of your large veins (central venous infusion).
If you received more Aminoplasmal 10% 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 flowing too fast, you may feel sick, may have to vomit and/or have a headache. Also, your blood may contain too much ammonia (hyperammonaemia) and you may lose amino acids in the urine. You may also suffer from too much fluid in your body (hyperhydration), your body’s salt balance may be disturbed (electrolyte imbalance) and you may have water on your lungs (pulmonary oedema). If this happens, the infusion will be stopped and started again at a lower infusion rate some time later.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Such side effects are not specifically related to Aminoplasmal 10% 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
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Aminoplasmal 10%
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle and carton labels. The expiry date refers to the last day of that month.
Keep the bottle in the outer carton in order to protect from light.
Do not store above 25 °C.
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.
Do not freeze.
After infusion, any remaining solution should never be stored for later use.
6. Contents of the pack and other information
What Aminoplasmal 10 % contains
The active substances are amino acids.
This medicine contains:
per
1 ml
per
250 ml
per
500 ml
per 1000 ml Isoleucine 5.00 mg 1.25 g 2.50 g 5.00 g Leucine 8.90 mg 2.23 g 4.45 g 8.90 g Lysine monohydrate 3.12 mg 0.78 g 1.56 g 3.12 g (equivalent to lysine) (2.78 mg) (0.70 g) (1.39 g) (2.78 g) Lysine acetate 5.74 mg 1.44 g 2.87 g 5.74 g (equivalent to lysine) (4.07 mg) (1.02 g) (2.04 g) (4.07 g) Methionine 4.40 mg 1.10 g 2.20 g 4.40 g Phenylalanine 4.70 mg 1.18 g 2.35 g 4.70 g Threonine 4.20 mg 1.05 g 2.10 g 4.20 g Tryptophan 1.60 mg 0.40 g 0.80 g 1.60 g Valine 6.20 mg 1.55 g 3.10 g 6.20 g Arginine 11.50 mg 2.88 g 5.75 g 11.50 g Histidine 3.00 mg 0.75 g 1.50 g 3.00 g Alanine 10.50 mg 2.63 g 5.25 g 10.50 g Glycine 12.00 mg 3.00 g 6.00 g 12.00 g Aspartic acid 5.60 mg 1.40 g 2.80 g 5.60 g Glutamic acid 7.20 mg 1.80 g 3.60 g 7.20 g Proline 5.50 mg 1.38 g 2.75 g 5.50 g Serine 2.30 mg 0.58 g 1.15 g 2.30 g Tyrosine 0.40 mg 0.10 g 0.20 g 0.40 g
The other ingredients are acetylcysteine, citric acid monohydrate (for pH-adjustment) and water for injections.
Electrolyte concentrations
Acetate 28 mmol/l Citrate 1.0 – 2.0 mmol/l
Total amino acids 100 g/l Total nitrogen 15.8 g/l
Energy [kJ/l (kcal/l)] 1675 (400) Theoretical osmolarity [mOsm/l] 864 Acidity (titration to pH 7.4) [mmol NaOH/l] approx. 20 pH 5.7 – 6.3
B. Braun Melsungen AG
34209 Melsungen, Germany B|BRAUN
0451/12260941/0625
The following information is intended for healthcare professionals only:
Dosage
In the case of amino acid requirements of 1.0 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.
Patients with renal/hepatic impairment
The doses should be adjusted individually in patients with mild to moderate hepatic or decompensated liver cirrhosis with hepatic encephalopathy (grades I and II) or renal insufficiency. When given during dialysis amino acid losses into the dialysate have to be considered.
Instructions for handling
Use a sterile giving set for infusion of Aminoplasmal 10%.
If in the setting of complete parenteral nutrition it is necessary to add other nutrients such as carbohydrates, lipids, vitamins, electrolytes and trace elements to this medicinal product, admixing must be performed under strict aseptic conditions. Mix well after admixture of any additive. Aminoplasmal 10% can only be mixed with other nutrients for which compatibility has been documented. Compatibility data for different additives and the corresponding shelf life of such admixtures can be provided on demand by the manufacturer. Pay special attention to compatibility.
- Glucose: physicochemical stability has been demonstrated for 24 hours at room temperature up to a total quantity of 158 g/l of glucose in the mixture.
- Electrolytes: physicochemical stability has been demonstrated for 24 hours at room temperature up to a total quantity of 32 mmol/l of sodium, 16 mmol/l potassium and 2 mmol/l of magnesium in the mixture.
- Lipids: physicochemical stability has been demonstrated for 24 hours at room temperature up to a total quantity of 50 g/l of lipid emulsion in the mixture.
- Trace elements and vitamins: stability has been demonstrated for 24 hours at room temperature with commercially available multi-trace elements and multi-vitamins (e.g. Tracutil, Cernevit) up to the standard dosage recommended by the respective manufacturer of the micronutrient.
Special precaution for storage
The solution should only be used if the closure of the container is not damaged and if the solution is clear colourless to faintly straw-coloured, practically free from visible particles.
Containers are for single use only. Discard container and any unused contents after use.
Shelf life after admixture of additives
Do not refrigerate. Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C.
From a microbiological point of view, unless the method of opening and mixing precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. For complete information on this medicinal product please refer to the Summary of Product Characteristics. What Aminoplasmal 10% looks like and contents of the pack
Aminoplasmal 10% is a clear, colourless up to faintly straw-coloured
solution, practically free from visible particles.
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
34212 Melsungen
Germany
Postal address
34209 Melsungen, Germany
Phone: +49-5661-71-0
Fax: +49-5661-71-4567
This medicine is authorised in the Member States of the European Economics Area and in the United Kingdom (GB and NI) under the following names:
Austria, Germany Aminoplasmal B. Braun 10 % Infusionslösung Czech Republic,
Poland, Portugal,
Slovakia Aminoplasmal B. Braun 10 %
Denmark Aminoplasmal
Spain Aminoplasmal B. Braun 10 % solución para perfusión
Finland Aminoplasmal 16 N/l infuusioneste, liuos Italy Amixal
Lithuania Aminoplasmal B. Braun 10 % infuzinis tirpalas Latvia Aminoplasmal B. Braun 10 % šķīdums infūzijām Netherlands Aminoplasmal B. Braun 10 % E-vrij, oplossing voor infusie
Slovenia Amixal 100 mg/ml raztopina za infundiranje United Kingdom
(GB and NI) Aminoplasmal 10 % solution for infusion