Addaven ® concentrate for Solution

ADDAVEN is a sterile concentrated solution that contains a mixture of trace elements normally absorbed from the oral diet. Trace elements are tiny amounts of chemicals that your body needs to function normally. ADDAVEN is given intravenously (as a drip into a vein) when you cannot eat normally. This medicine is used as part of a balanced intravenous diet, together with proteins, fat, carbohydrates, salts and vitamins.

ADDAVEN should not be administered to you:

• if you are allergic (hypersensitive) to any of the ingredients of this medicine (listed in section 6). If you develop a rash or other allergic reactions (like itching, swollen lips or face, or shortness of breath), inform your doctor immediately;
• if your bile excretion is blocked (some signs may be pain on your tummy, dark urine, feeling feverish and nauseous);
• if you have Wilson’s disease (a genetic disorder in which copper builds up in the body) or haemochromatosis (accumulation of iron in the body).

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection: Special care should be taken with ADDAVEN:

• if you have problems with the way your liver and/or kidney work. ADDAVEN must not be given undiluted. See section 3.
• Iron and iodine may cause allergic reactions on rare occasions when given as a drip. Tell your doctor or nurse if you get any allergic reaction when receiving ADDAVEN.

Your doctor may want to do regular blood tests to check your condition. If you are taking iron orally in parallel with the infusion your doctor will check that iron is not accumulating in your body.

ADDAVEN should not be given to children aged less than 12 years as adequate safety data are not available for children.

Other medicines and ADDAVEN

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) No interactions with other medicines are known.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before receiving ADDAVEN.

Driving and using machines

ADDAVEN has no or negligible effect on driving and using machines. It is not always possible to predict to what extent ADDAVEN may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which ADDAVEN affects them.

You will not be expected to give yourself ADDAVEN. It will be given to you by a person who is qualified to do so. Your doctor will decide on the correct dose for you to receive. The usual dose is 10 millilitres (mL) each day. If you have problems with your liver or kidneys you may receive a lower dose.

You will receive your medicine by infusion (drip) into a vein. ADDAVEN should be mixed with another nutritional solution before it is given to you. Your doctor or nurse will make sure it is prepared correctly. Your doctor will tell you how long your treatment with ADDAVEN will last. If you have the impression that the effect of ADDAVEN is too strong or too weak, tell your doctor or nurse.

If you receive more ADDAVEN than you should Since a healthcare provider will administer ADDAVEN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to receive ADDAVEN Since a healthcare provider will administer ADDAVEN, it is unlikely that the dose will be missed.

ADDAVEN can have side effects. Not all side effects reported for ADDAVEN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving ADDAVEN, please consult your healthcare provider for advice.

If any of the following happens, stop receiving ADDAVEN and tell your doctor immediately:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ADDAVEN. You may need urgent medical attention or further hospitalisation.

Tell your doctor if you notice any of the following side effects:

Frequency unknown

• Headache
• Nausea, vomiting
• Chills, fever

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 (who-umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of ADDAVEN. 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 medicines regulatory authority in the country where the product is marketed.

Store all medicines out of reach of children. Store at or below 30 °C. After dilution: The addition of ADDAVEN should be performed immediately before the start of the infusion and should be used within 24 hours. Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of ADDAVEN. Do not use after the expiry date stated on the label.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).