Patient leaflet - Aminomix Peripheral 5.7 g/l Nitrogen, solution for infusion
1. What Aminomix Peripheral is and what it is used for
Aminomix Peripheral is a solution given intravenously (into a vein) when you cannot eat normally. The product contains amino acids (components used to build proteins), glucose (carbohydrate) and salts (electrolytes) in a plastic bag.
A doctor or healthcare professional will give you Aminomix Peripheral when other forms of feeding (eating or tube-feeding) are not possible or insufficient. Aminomix Peripheral is used to treat adults.
2. What you need to know before you use Aminomix Peripheral
Do not use Aminomix Peripheral,
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
if you have a genetic disorder in which the body does not properly break down (metabolise) amino acids;
M0xxxxx/00 UK
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi Ltd
Cestrian Court
Eastgate Way, Manor Park
Runcorn, Cheshire, WA7 1NT
United Kingdom
Manufacturer:
Fresenius Kabi Austria GmbH
Hafnerstraße 36
A-8055 Graz
Austria
This leaflet was last revised in November 2023.
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The following information is intended for healthcare professionals only:
Warnings and Precautions for use
Individual adjustment of dose as well as regular clinical and laboratory controls are required in patients with hepatic, renal, cardiac or pulmonary disease and in patients with altered amino acid and glucose metabolism as well as lactic acidosis and increased serum osmolarity.
Depending on the clinical condition, blood levels of glucose, urea, ammonia, and electrolytes should be controlled. Patients receiving intravenous nutrition should be monitored according to the current guidelines.
Given the risk of infection associated with the use of any intravenous infusion, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation. The catheter insertion site should be inspected daily for local signs of irritation and thrombophlebitis to evaluate changing the infusion site.
- 1. Remove the overpouch
- 2.
Mixing
- Remove the overpouch
- Place the bag on a flat surface with the ports pointing away.
- Roll the bag straight from the top (handle) down to the ports until the peel seal has opened.
After separation of the peelable seal, the bag should be inverted
repeatedly to ensure a homogenous mixture.
- - if you have too much fluid in your body (hyperhydration) or lungs (pulmonary oedema), that has not been treated;
- - if you have an untreated heart insufficiency;
- - if you have persistent low blood pressure not capable of bringing oxygen to the brain and other organs (uncorrected circulatory shock);
- - if you have too low levels of oxygen in your body tissue (hypoxia) that is not treated;
- - if you have serious liver disease that is not treated;
- - if you have serious kidney disease without access to blood filtration (dialysis);
- - if you have disturbed metabolism that is not treated;
- - in newborns or infants below 2 years of age;
- - if you have high levels of electrolytes (salts) included in Aminomix Peripheral.
Warnings and precautions
Talk to your doctor or pharmacist <or nurse> before using Aminomix Peripheral:
- if you have liver, kidney, heart, or lung disease;
- if your body has problems using amino acids and glucose;
- if you do not receive enough or adequate food (you are underfed).
If during the infusion you notice fever, rash, difficulty in breathing, shivering, sweating, nausea or vomiting, tell the healthcare professional immediately because these symptoms might be caused by an allergic reaction or that you may have been given too much of the medicine.
Your doctor may regularly need to check your blood.
Children and adolescents
Due to its amino acid composition Aminomix Peripheral is not suitable for newborns or infants below 2 years of age. Currently, there is no experience with the use of Aminomix Peripheral in children from 2 to 18 years old.
Other medicines and Aminomix Peripheral
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant, breast-feeding or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
No studies from use of Aminomix Peripheral during pregnancy or breast-feeding are available. Aminomix Peripheral should be given to pregnant or breast feeding women only if the doctor finds it absolutely necessary. No special precautions have to be considered regarding contraception in males and females and fertility.
Aminomix Peripheral contains
Glucose: Contains 63 g Glucose/l. This should be taken into account in patients with diabetes mellitus.
Potassium: This medicinal product contains 19 mmol potassium/l. To be taken into consideration in patients with reduced kidney function or patients on a controlled potassium diet.
Sodium: This medicinal product contains 25 mmol sodium/l. To be taken into consideration in patients on a controlled sodium diet
Phenylalanine: This medicinal product contains 1.79 mg phenylalanine/l and may be harmful for people with phenylketonuria.
3. How to use Aminomix Peripheral
Aminomix Peripheral will be given to you by a healthcare professional intravenously by infusion via a peripheral or central vein.
Check with your doctor or pharmacist if you are not sure.
Your doctor will decide on the dose for you individually depending on your body weight and function.
If you received more Aminomix Peripheral than you should
It is very unlikely that you will receive more infusion than you should because your doctor or healthcare professional will monitor you during the infusion.
Symptoms of overdose or too rapid infusion may include nausea, vomiting, shivering, sweating, fever or difficulty in breathing. If you experience these symptoms or believe that you have received too much Aminomix Peripheral, inform the healthcare professional immediately. The infusion will be reduced or stopped if this happens.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects known for similar products might also appear for Aminomix Peripheral.
If you experience fever, shivering, rash, difficulty in breathing, you might have an allergic reaction; inform your healthcare professional immediately. An injection site irritation and inflammation of a vein may be caused by or associated with a blood clot (thrombophlebitis). The likelihood of occurrence is not known (cannot be estimated from the available data).
Reporting of side effects
If you get any side effects, talk to your doctor orpharmacist <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
Website: 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 Aminomix Peripheral
Keep this medicine out of the sight and reach of children.
Do not store above 30 °C.
Do not freeze.
Store in overpouch. Keep the bag in the outer carton to protect from light.
Do not use this medicine after the expiry date which is stated on the label on the bag and box after “EXP”. The expiry date refers to the last day of that month.
Any unused solution should be discarded.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Aminomix Peripheral contains
| The active substances are: | g / 1000 ml |
| L-Alanine | 4.90 |
| L-Arginine | 4.20 |
| Glycine | 3.85 |
| L-Histidine | 1.05 |
| L-Isoleucine | 1.75 |
| L-Leucine | 2.59 |
| L-Lysine | 2.31 |
| L-Methionine | 1.51 |
| L-Phenylalanine | 1.79 |
| L-Proline | 3.92 |
| L-Serine | 2.28 |
| Taurine | 0.35 |
| L-Threonine | 1.54 |
| L-Tryptophan | 0.70 |
| L-Tyrosine | 0.14 |
| L-Valine | 2.17 |
| Calcium chloride | 0.18 |
| Sodium glycerophosphate | 1.78 |
| Magnesium sulphate | 0.38 |
| Potassium chloride | 1.41 |
| Sodium acetate | 0.70 |
| Glucose | 63.0 |
Corresponding to:
Amino acids 35 g, Nitrogen 5.7 g, Carbohydrates (glucose) 63 g, Electrolytes; sodium 25 mmol, potassium 19 mmol, magnesium 3.1 mmol, calcium 1.6 mmol, phosphorus 8.2 mmol, sulphate 3.1 mmol, chloride 22 mmol.
Energy content total approx. 390 kcal
Energy content non protein approx. 250 kcal
Osmolality: approx. 860 mOsm/kg water
Osmolarity (theoretical): approx. 770 mOsm/l pH (after mixing): approx. 5.6
- The other ingredients are:
acetic acid (pH-adjustment) and water for injections.
What Aminomix Peripheral looks like and contents of the pack
Aminomix Peripheral is supplied in double chambered bags of 1000, 1500 and 2000 ml, packed in cartons. The container consists of a double chamber inner bag and an overpouch. The inner bag is separated into two chambers by a peelable seal. An oxygen absorber is placed between the inner bag and the overpouch.
The solution for infusion is clear, colourless or slightly yellowish and free of visible particles.
Pack sizes:
1 x 1000 ml, 6 x 1000 ml
1 x 1500 ml, 4 x 1500 ml
1 x 2000 ml, 4 x 2000 ml
Not all pack sizes may be marketed