Aminoven 5 %/10 %/15 % Solution

AMINOVEN 5 %, 10 % or 15 % provides nourishment straight into your blood stream when you cannot eat normally. It provides amino acids which your body will use to make proteins (to build and repair muscles, organs, and other body structures). AMINOVEN 5 %, 10 % and 15 % are administered through an injection into a vein when oral supply of amino acids is not possible, not enough or not allowed due to a medical condition.

AMINOVEN 5 %, 10 % or 15 % should not be administered to you:

• If you are hypersensitive (allergic) to any of the ingredients in AMINOVEN 5 %, 10 % or 15 %.
• If you have a condition which causes a low oxygen supply to your body (hypoxia).
• If your doctor confirms that you have disturbances in sodium, potassium or amino acid concentrations in your body.
• If you have a liver or kidney disorder and are not on dialysis or another form of blood filtration treatment.
• If you have high blood sugar and you require 6 or more units of insulin per hour.
• If you have a heart disorder (decompensated heart failure).
• If you have an excessive amount of fluids in your body (a condition called overhydration).
• If you have a condition where your body has problems using proteins or amino acids.
• If you have metabolic acidosis (the acid levels of your body fluids and tissues become too high).
• If you suffer from shock.

Your child should not receive AMINOVEN 5 % and 10 % if your child is younger than 2 years of age. Your child should not receive AMINOVEN 15 %.

Warnings and precautions

Tell your doctor or healthcare professional before being given the injection:

• If you have a heart disorder (cardiac insufficiency) and the doctor need to infuse a large volume of fluids.
• If your doctor prescribes amino acid solutions daily, as folic acid deficiency may develop. Your doctor may need to prescribe a folic acid supplement daily as well.
• If you suffer from low levels of potassium (hypokalaemia).
• If you suffer from low levels of sodium (hyponatraemia). Your doctor may need to draw blood regularly to monitor you or your child’s electrolyte and blood sugar levels. Your doctor may also need to test you or your child’s kidney function regularly.

You will not be expected to give yourself AMINOVEN 5 %, 10 % or 15 %. It will be given to you by a person who is qualified to do so. You will receive your medicine by infusion (IV drip). AMINOVEN 5 %, 10 % and 15 % will only be administered through a vein in a hospital. The amount and rate at which the infusion is given depends on your requirements. AMINOVEN 15 % is not intended for children. See section 2. Your doctor will decide on the correct dose for you or child and how long your treatment or your child’s treatment will be. You may be monitored during your treatment.

If you receive more AMINOVEN 5 %, 10 % or 15 % than you should Since a healthcare provider will administer AMINOVEN 5 %, 10 % or 15 %, he/she will control the dosage. However, in the event of overdosage, your doctor/ your child’s doctor will manage the overdosage. The effects of an overdose may include nausea, vomiting and shivering.

If you forget to take AMINOVEN 5 %, 10 % or 15 % Since a healthcare provider will administer AMINOVEN 5 %, 10 % or 15 %, it is unlikely that the dose will be missed.

AMINOVEN 5 %, 10 % and 15 % may have side effects. Not all side effects reported for AMINOVEN 5 %, 10 % and 15 % are included in this leaflet. Should your, or your child’s general health worsen or if you experience any untoward effects while receiving AMINOVEN 5 %, 10 % and 15 %, please consult your healthcare provider for advice.

Side effects you may experience include:

• Nausea and vomiting
• Pain and irritation where AMINOVEN 5 %, 10 % and 15 % is injected into your body.

The following side effects have been observed when infusion was administered too quickly:

• loss of potassium or sodium from the blood
• folate deficiency

At the site of injection the following side effects may occur:

• soreness and tenderness of the vein
• thrombosis (the formation of a clot) in the vein where the injection is given

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of AMINOVEN 5 %, 10 % or 15 %.

• Store at or below 25 °C.
• Do not freeze.
• Keep container in the outer carton.
• Store all medicines out of reach of children.
• Do not use AMINOVEN 5 %, 10 % or 15 % after the expiry date.
• Return all unused medicine to the pharmacy for disposal.