ClinOleic 20%

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet, see section 4.

1 What ClinOleic is and what it is used for
2 What you need to know before you are given ClinOleic
3 How ClinOleic is given
4 Possible side effects
5 How ClinOleic is stored
6 Contents of the pack and other information

Throughout this leaflet ClinOleic 20% will be called ClinOleic.

• are allergic (hypersensitive) to the active substances (egg, soybean or peanut protein) or to any of the other ingredients (see section 6, “Further information” at the end of this leaflet). Signs of an allergic reaction include being short of breath, wheezing, rash, itching or swelling of the face and lips,
• have a problem with the way your body handles fat, especially if tests show that you have a high amount of fat in your blood,
• have problems with your kidneys (lipoid nephrosis) or inflammation of the pancreases (acute pancreatitis) if accompanied by high levels of fat in your blood.

Do not use ClinOleic if any of the above apply to you. If you are not sure talk to your doctor or nurse before using ClinOleic.

Your doctor will take special care with ClinOleic if:

Special clinical monitoring is required at the start of any infusion into your veins (intravenous infusion). The infusion will be stopped immediately if you have any sign of allergic reaction. Signs include sweating, fever, chills, headache, skin rash, dyspnoea (difficulty to breathe). This medicinal product contains soya‑bean oil and egg phospholipids. Soybean and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soybean and peanut proteins have been observed.

Certain medications and illnesses can increase the risk of developing infection or sepsis (bacteria in the blood). There is a particular risk of infection or sepsis when a tube is placed in your vein. Your doctor will carefully watch you for any signs of infection.

Your doctor should be aware of:

• severe conditions affecting how your body handles sugars, fats, proteins or salt (metabolic disorders)
• a severe blood infection (sepsis)
• a severe liver disease
• a blood clotting (coagulation) disorder

If you are not sure if any of the above apply to you, talk to your doctor or nurse before being given ClinOleic.

ClinOleic is suitable for use in young children if its use is monitored carefully.

When used in neonates and children below 2 years of age, the solution (in bags and administration sets) should be protected from light exposure until administration is completed. Exposure of Clinoleic to ambient light, especially after admixtures with trace elements and/or vitamins, generates peroxides and other degradation products that can be reduced by protection from light exposure.

Severe side effects such as rapid breathing or difficulty breathing leading to reduced oxygen in the body and conditions leading to acid build up in the body have been reported in newborn babies (neonates) and young children (infants) after rapid administration of lipids into the blood vessels (see also section 3, If you are given more ClinOleic than you should).

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

The olive and soybean oils present in ClinOleic contain vitamin K. This does not normally affect blood thinning medicines (anticoagulants) like coumarin. However, if you take anticoagulant medicines you should tell your doctor.

If you are pregnant, think you might be pregnant, or are breastfeeding, tell your doctor. He or she will decide if you can be given ClinOleic.

An overdose can cause a reduction in your body’s ability to remove lipids from ClinOleic (fat overload syndrome). In newborn babies (neonates) and young children (infants), an overdose and/or rapid administration of ClinOleic into the blood vessels (increased infusion rate) may cause severe side effects such as rapid breathing or difficulty breathing leading to reduced oxygen in the body (respiratory distress) and conditions leading to acid build up in the body (metabolic acidosis).

The effects of the overdose are usually reversible when the infusion of ClinOleic is stopped (see also section 4. Possible side effects).

Your doctor will stop giving you ClinOleic or reduce the amount you are given until the level of fats in your blood returns to normal (see also section 4. Possible side effects).

• The active substances are refined olive oil (80%) and refined soybean oil (20%) making up 200 g in 1000 ml of emulsion.
• The other ingredients are glycerol, egg phospholipids, sodium oleate and sterile water (called ‘water for injections’). It may also contain very small amounts of sodium hydroxide. This can be used to modify the acid level of ClinOleic.

ClinOleic is supplied as an emulsion for infusion (slow injection or drip) in a plastic bag container in a plastic overwrap which contains either 100 ml, 250 ml, 350 ml or 500 ml of emulsion. These pack sizes may not all be marketed. A 1000 ml volume is also available, for pharmacy use only.

An oxygen absorber/ oxygen indicator sachet is included inside the overwrap. Before opening the overwrap, the colour of the oxygen indicator affixed to the oxygen absorber should be checked. It should match the reference colour printed next to the OK symbol and shown in the printed area of the indicator label. The sachet should be disposed of after removing the overwrap.

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ClinOleic is made at: