Aminoplasmal 15% Solution For Infusion
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Package leaflet: Information for the user
B. Braun Melsungen AG • 34209 Melsungen, Germany
Aminoplasmal® 15% = solution for infusion
481/12615962/1014
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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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Aminoplasmal® 15% is and what it is used for
2. What you need to know before you use Aminoplasmal® 15%
3. How to use Aminoplasmal® 15%
4. Possible side effects
5. How to store Aminoplasmal® 15%
6. Contents of the pack and other information
1. What Aminoplasmal® 15% is and what it is used for
Aminoplasmal® 15% is a solution for parenteral nutrition (intravenous feeding). You will be given this medicine through a small tube placed in a vein (intravenous drip or infusion).
It will supply you with amino acids when you are unable or not allowed to eat normally and you cannot be fed through a tube placed into your stomach either.
2. What you need to know before you use Aminoplas-mal® 15%
Do not use Aminoplasmal® 15%
• if you are allergic to any of the active substances or to any of the other ingredients of this medicine (listed in section 6).
• if you have inborn disorders of your amino acid metabolism
• if you have severe life-threatening impairment of your circulation (state of shock)
• if you have inadequate supply of oxygen to cells (hypoxia)
• if you have an abnormally high level of acids in the blood (metabolic acidosis)
• if you have severe liver disease (severe hepatic insufficiency)
• if you have severe kidney failure (severe renal insufficiency) not treated with dialysis or haemofiltration
• if you have a severe heart weakness with impaired circulation (decompensated cardiac insufficiency)
• if you have water on the lungs (lung oedema)
• if you have excess body fluids (hyperhydration)
This solution is not suitable for children under 2 years because of its composition, so they should not receive it.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Aminoplasmal® 15%. If you have a not inborn disorder of protein metabolism, your doctor will decide very carefully whether or not this medicine can or even must be given to you.
If your heart function is impaired, your daily fluid intake will be controlled very carefully in order to avoid any overload of your circulation.
If the overall concentration of dissolved substances in your blood is too high, your doctor will exercise particular caution in order to avoid worsening of this condition.
If your liver or your kidneys do not work well, your daily dose will be adjusted very carefully according to the impairment of your liver or kidney function and your type of treatment.
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 potassium or sodium, you will receive sufficient amounts of these.
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.
To make your intravenous feeding complete, you will also receive carbohydrate solutions and possibly also fat emulsions. Further you will be given essential fatty acids, vitamins, fluids, trace elements and electrolytes as necessary.
Other medicines and Aminoplasmal® 15%
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
There are no data from the use of Aminoplasmal® 15% in pregnant women. If you are pregnant, you will receive this medicine only if the doctor considers it absolutely necessary for your recovery. Aminoplasmal® 15% should only be given to pregnant women after careful consideration.
Breast-feeding
At therapeutic doses of Aminoplasmal® 15% no effects on the breastfed newborns/infants are anticipated. Nevertheless, breast-feeding is not recommended if women need intravenous feeding in that time.
Driving and using machines
This medicine has no influence on your ability to drive and use machines. Aminoplasmal® 15% contains sodium.
This medicine contains 5.3 mmol sodium per 1000 ml.
To be taken into consideration by patients on a controlled sodium diet.
3. How to use Aminoplasmal® 15%
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
The amount of solution you are going to receive depends on your requirement of amino acids and fluid and also on your actual condition or disease.
Adults
The usual dose is 6.7 ml to 13.3 ml max. per kg body weight per day.
This corresponds to 1.0 - 2.0 g of amino acids per kg body weight per day. This solution will be administered to you at a maximum rate of 0.67 ml per kg body weight per hour.
Use in children
Aminoplasmal® 15% must not be given to children under 2 years (see section 2 'What you need to know before you use...').
The dosage for children is adjusted individually according to age, status of development and clinical condition of the child.
The following may be taken as a guidance for the daily doses:
• For children 2 to 17 years old: 6.7 - 13.3 ml per kg body weight per day, corresponding to 1.0 g - 2.0 g of amino acids per kg body weight per day
BIBRAUN
Schwarz 210x297 mm 481/12615962/1014 Latus: 1856 GroBbritannien Font size 9,5
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481/12615962/1014
_ • Critically ill children: If your child is critically ill, the amount of amino
acids required may be higher (up to 3.0 g amino acids/kg body weight per day).
The rate of infusion should not be higher than 0.67 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 or kidney disease.
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 by infusion (drip) in a large central vein.
If you use more Aminoplasmal® 15% than you should
Overdose or too rapid infusion may not be tolerated well and you may feel sick, may have to vomit and may experience shivering or headache. Also, your blood may contain too much acidic substances and you may lose amino acids in the urine.
If this occurs, your infusion will be stopped and started again at a lower rate some time later.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the medicine is used according to the directions given, no side effects are to be expected.
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.
5. How to store Aminoplasmal® 15%
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 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 from light.
Do not freeze.
Only to be used if the solution is clear and colourless or faintly straw-coloured and the bottle and its closure are undamaged.
The bottles are for single use only. Any solution remaining after an infusion and the container must be disposed of after use.
6. Contents of the pack and other information
What Aminoplasmal® 15% contains
The active substances are amino acids. 1000 ml of the solution contain:
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Isoleucine |
5.85 g |
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Leucine |
11.40 g |
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Lysine monohydrate |
8.93 g |
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(equivalent to lysine) |
(7.95 g) |
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Methionine |
5.70 g |
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Phenylalanine |
5.70 g |
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Threonine |
5.40 g |
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Tryptophan |
2.10 g |
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Valine |
7.20 g |
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Arginine |
16.05 g |
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Histidine |
5.25 g |
(equivalent to cysteine) (0.37 g)
The other ingredients are sodium hydroxide, citric acid monohydrate and water for injections.
Energy [kJ/l (kcal/l)] 2505 (600)
Theoretical osmolarity [mOsm/l] 1290
Titration acidity (to pH 7.4) [mmolNaOH/l] approx. 31
pH 5.7 - 6.3
What Aminoplasmal® 15% looks like and contents of the pack
Aminoplasmal® 15% is a solution for infusion. The solution is clear, colourless or faintly straw-coloured.
Aminoplasmal® 15% is supplied in glass bottles, sealed with rubber stopper:
• Contents: 500 ml, 1000 ml
• Pack sizes: 1 x 500 ml, 10 x 500 ml, 1 x 1000 ml, 6 x 1000 ml Not all pack sizes may be marketed.
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: +49-5661-71-4567
This medicinal product is authorised in the Member States of the EEA under the following names:
France AMINOPLASMAL 25, solution pour perfusion
Germany AMINOPLASMAL - 15 % elektrolyt- und kohlenhydratfrei
Poland AMINOPLASMAL 15 %
Spain AMINOPLASMAL B.BRAUN 15% solucion para perfusion
United Kingdom Aminoplasmal® 15% solution for infusion
This leaflet was last revised in September 2014
The following information is intended for healthcare professionals only:
Aminoplasmal® 15% should only be mixed with other iv solutions, if compatibility has been proven in advance. Compatibility data for different additives (e.g. glucose, lipids, electrolytes, trace elements, vitamins) and the corresponding shelf-life of such admixtures can be provided on demand by the manufacturer.
Chemical and physical in-use stability after mixture with other components of parenteral nutrition has been demonstrated for 7 days at 2-8°C plus 2 days at 25°C. Detailed information on tested components (e.g. glucose, lipids, electrolytes, trace elements, vitamins) and shelf life can be provided on demand by the manufacturer.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
It is essential that any admixture be prepared using strict aseptic techniques as this nutrient mixture supports microbial growth.
Cool storage of the undiluted 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.
B. Braun Melsungen AG
34209 Melsungen Germany
Schwarz 210x297 mm 481/12615962/1014 Latus: 1856 GroBbritannien Font size 9,5