Nutriflex Omega Plus Emulsion for Infusion

NUTRIFLEX OMEGA PLUS contains fluids and substances called amino acids, electrolytes and fatty acids that are essential for the body to grow or to recover. It also contains calories in the form of carbohydrates and fats.

You are given NUTRIFLEX OMEGA PLUS when you are unable to eat food normally. There are many situations when this might be the case, for example when you are recovering from surgery, injuries, or burns, or when you are unable to absorb food from your stomach and gut. NUTRIFLEX OMEGA PLUS is given to adults.

NUTRIFLEX OMEGA PLUS should not be administered to you:

• if you are hypersensitive (allergic) to any of the active ingredients or any of the other ingredients of NUTRIFLEX OMEGA PLUS (listed in section 6)
• if you are allergic to egg, peanut, soyabean or fish.

This medicine must not be given to newborn infants, infants and toddlers under two years old. Also do not use NUTRIFLEX OMEGA PLUS if you suffer from any of the following:

• life-threatening blood circulation problems such as those that can occur if you are in a state of collapse or shock
• heart attack or stroke
• severely impaired blood clotting function, bleeding risk (severe coagulopathy, aggravating haemorrhagic diatheses)
• blocking of blood vessels by blood clots or fat (embolism)
• severe liver failure
• impaired bile flow (intrahepatic cholestasis)
• severe kidney failure where no dialysis facilities are available
• disturbances of your body salt composition
• fluid deficit or excess water in your body
• water on your lungs (pulmonary oedema)
• severe heart failure
• certain metabolic disorders such as:
• too much lipid (fat) in the blood
• inborn errors of amino acid metabolism
• abnormally high blood sugar level that needs more than 6 units of insulin per hour to be controlled
• abnormalities of metabolism that may occur after operations or injuries
• coma of unknown origin
• insufficient supply of oxygen to tissues
• abnormally high acid level in the blood.

Warnings and precautions

Take special care with NUTRIFLEX OMEGA PLUS:

• if you have heart, liver or kidney problems
• you suffer from certain types of metabolic disorders such as diabetes, abnormal blood fat values and disorders of your body fluid and salt composition
• your blood clotting function is impaired or if your vitamin K level might be too low.

You will be monitored closely to detect early signs of an allergic reaction (such as fever, shivering, rash, or shortness of breath) when you receive this medicine. Further monitoring and tests such as various examinations of blood samples will be applied to make sure that your body handles the administered foodstuffs properly. The healthcare professional may also take measures to ensure that your body’s fluid and electrolyte requirements are met. In addition to NUTRIFLEX OMEGA PLUS you may receive further nutrients (foodstuffs) in order to fully recover your requirements.

Children and adolescents

Safety and efficacy in children and adolescents have not been established. This medicine must not be given to newborn infants, infants and toddlers under two years old.

Other medicines and NUTRIFLEX OMEGA PLUS:

Always tell your healthcare professional if you are taking any other medicine (this includes complementary or traditional medicines). NUTRIFLEX OMEGA PLUS can interact with some other medicines. Please tell your doctor if you are taking or receiving any of the following:

• insulin
• heparin
• medicines that prevent undesirable blood clotting such as warfarin or other coumarin derivatives
• medicines to promote urine flow (diuretics)
• medicines to treat high blood pressure or heart problems (ACE-inhibitors and angiotensin-II-receptor antagonists)
• medicines used in organ transplants such cyclosporin and tacrolimus
• medicines to treat inflammation (corticosteroids)
• hormone preparations that affect your fluid balance (adrenocorticotropic hormone [ACTH]).

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 health care provider for advice before taking this medicine. If you are pregnant, you will receive this medicine only if the doctor considers it absolutely necessary for your recovery. There is no data available about the use of NUTRIFLEX OMEGA PLUS in pregnant women. Breastfeeding is not recommended for mothers on parenteral nutrition.

Your doctor will tell you how long your treatment with NUTRIFLEX OMEGA PLUS will last. If you have the impression that the effect of NUTRIFLEX OMEGA PLUS is too strong or too weak, tell your doctor or pharmacist. You will not be expected to give yourself NUTRIFLEX OMEGA PLUS. It will be given to you by a person who is qualified to do so.

This medicine is administered by intravenous infusion (drip), that is, through a small tube directly into a vein. This medicine will be administered through one of your large (central) veins only. The recommended duration of infusion for a parenteral nutrition bag is maximum 24 h. Your doctor will decide how much of this medicine you need and for how long you will require treatment with this medicine.

Use in children and adolescents

Safety and efficacy in children and adolescents have not been established. This medicine must not be given to newborn infants, infants and toddlers under two years old.

If you use more NUTRIFLEX OMEGA PLUS than you should

Since a health care provider will administer NUTRIFLEX OMEGA PLUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. If you have received too much of this medicine, you may suffer from a so-called ‘overload syndrome’ and the following symptoms:

• fluid excess and electrolyte disorders
• water in your lungs (pulmonary oedema)
• loss of amino acids through the urine and disturbed amino acid balance
• vomiting, feeling sick
• shivering
• high blood sugar level
• glucose in the urine
• fluid deficit
• blood much more concentrated than normal (hyperosmolality)
• impairment of loss of consciousness due to extremely high blood sugar
• enlargement of the liver (hepatomegaly) with and without jaundice (icterus)
• enlargement of the spleen (splenomegaly)
• fat deposition in the inner organs
• abnormal values of liver function tests
• reduction of red blood cell count (anaemia)
• reduction of white blood cell count (leukopenia)
• reduction of blood platelet count (thrombocytopenia)
• increase of immature red blood cells (reticulocytosis)
• rupture of blood cells (haemolysis)
• bleeding or a tendency to bleed
• impairment of blood coagulation (as can be seen by changes of bleeding time, coagulation time, prothrombin time)
• fever
• high blood fat levels
• loss of consciousness.

If any of these symptoms occur, the infusion must be stopped immediately. If you have any further questions on the use of this medicine, ask your doctor. If you forget to use NUTRIFLEX OMEGA PLUS Since a health care provider will administer NUTRIFLEX OMEGA PLUS, it is unlikely that the dose will be missed.

NUTRIFLEX OMEGA PLUS can have side effects. Not all side effects reported for NUTRIFLEX OMEGA PLUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NUTRIFLEX OMEGA PLUS, please consult your doctor, pharmacist or other healthcare professional for advice.

The following side effects may be serious. If any of the following side effects occur, tell your doctor immediately, he will stop giving you this medicine:

Less frequent side effects:

• allergic reactions, for example skin reactions, shortness of breath, swelling of the lips, mouth and throat, difficult breathing
• feeling sick, vomiting, loss of appetite
• increased tendency for your blood to clot
• bluish discolouration of the skin
• shortness of breath
• headache
• flushing
• reddening of skin (erythema)
• sweating
• chills
• feeling cold
• high body temperature
• drowsiness
• pain in the chest, back, bones or lumbar region
• decrease or increase in blood pressure
• abnormally high blood fat or blood sugar values
• high levels of acidic substances in your blood
• too much lipid can lead to fat overload syndrome, for more information see section 3 “If you use more NUTRIFLEX OMEGA PLUS than you should.” Symptoms normally disappear when the infusion is stopped.

Frequency not known:

• reduction of white blood cell count (leucopenia)
• reduction of blood platelet count (thrombocytopenia)
• impaired bile flow (cholestasis).

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. This includes any possible side effects not listed in this leaflet. You can also report side effects via https://primaryreporting.who-umc.org/ZA. By reporting side effects, you can help provide more information on the safety of NUTRIFLEX OMEGA PLUS.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C. Do not freeze. If accidentally frozen, discard the bag. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last date of that month. Keep the bags in the overwrap in order to protect from light.