Aminosteril N – Hepa 8 % Solution

AMINOSTERIL N - HEPA 8 % is an amino acid solution intended for intravenous (IV) infusion. It belongs to the group of amino acids used for parenteral nutrition. The solution contains all essential amino acids which are the building blocks for your body to make proteins. Proteins are essential for your body to build and repair muscles, bones, tissue and to make enzymes and hormones. Your doctor has prescribed AMINOSTERIL N - HEPA 8 % because you have reduced liver function. It will be given to you directly into your bloodstream.

AMINOSTERIL N - HEPA 8 % should not be administered to you :

• If you are hypersensitive (allergic) to or any of the ingredients of AMINOSTERIL N - HEPA 8 % (listed in section 6).
• If you have a condition where your body has a problem using amino acids properly.
• If you have a condition called metabolic acidosis where there is too much acid in your body.
• If you have an excessive amount of fluid in your body (fluid overload).
• If the levels of sodium or potassium in your blood are too low.
• If the levels of potassium in your blood are too high.
• If you have kidney or heart problems.
• If you have a condition called hypoxia, where parts of the body are not getting enough oxygen.
• If you are suffering from shock.
• If you are pregnant or breastfeeding.

Warnings and precautions

Tell your doctor or health care provider if you notice pain, tenderness, swelling or warmth at the injection site. Your doctor may need to take special precautions before starting treatment, including:

• Monitoring serum electrolytes, fluid balance, and acid - base balance, including blood glucose levels, serum proteins, creatinine, and liver function tests.
• Ensuring electrolytes and carbohydrates are administered in balanced doses through infusion if necessary.
• Considering whether to use a central or peripheral vein based on the final osmolarity of the solution.
• Regularly checking the infusion site to minimise the risk of thrombophlebitis (superficial vein inflammation) when administered via a peripheral vein.

Children and adolescents

There is no experience in children.

Other medicines and AMINOSTERIL N - HEPA 8 %

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) There are no known interactions with other medicines. AMINOSTERIL N - HEPA 8 % should not be mixed with other medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or other health care provider for advice before receiving this medicine.

Driving and using machines

AMINOSTERIL N - HEPA 8 % has no effect on your ability to drive or use machines. It is not always possible to predict to what extent AMINOSTERIL N - HEPA 8 % may interfere with the daily activities of a patient. Patients should ensure that they not engage in the above activities until they are aware of the measure to which AMINOSTERIL N - HEPA 8 % affects them.

You will not be expected to give yourself AMINOSTERIL N - HEPA 8 %. It will be given to you by a person who is qualified to do so. You will receive your medicine by infusion (injected into your vein). Your doctor will decide on the correct dose for you and how long your treatment will be. You may be monitored during your treatment.

If you receive more AMINOSTERIL N - HEPA 8 % than you should

Since a health care provider will administer AMINOSTERIL N - HEPA 8 %, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. You may experience nausea, vomiting and chills or loss of amino acids via the kidneys. Rapid infusion through peripheral veins may cause thrombophlebitis. If these symptoms occur, the infusion will be slowed or stopped.

If a dose of AMINOSTERIL N - HEPA 8 % is forgotten

Since a health care provider will administer AMINOSTERIL N - HEPA 8 %, it is unlikely that the dose will be missed.

AMINOSTERIL N - HEPA 8 % can have side effects. Not all side effects reported for AMINOSTERIL N - HEPA 8 % are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving AMINOSTERIL N - HEPA 8 %, please consult your health care provider for advice.

If any of the following happens, tell your doctor or healthcare provider to stop AMINOSTERIL N - HEPA 8 % or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• Rash or itching
• Fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to AMINOSTERIL N - HEPA 8 %. you may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• pain, tenderness, swelling or warmth at the injection site

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, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (whoumc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of AMINOSTERIL N - HEPA 8 %. Patients are asked to report any suspected adverse drug reactions to their healthcare provider or Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed.

Store all medicine out of reach of children. Store at or below 25 °C. Do not freeze. Keep in the original packaging to protect from light. Do not use this medicine after the expiration date stated on the packaging. The doctor or nurse will check that the solution is clear and free from visible particles before use.