200 mg / ml infusion solution , emulsion 
Refined olive oil and refined soybean oil

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet you will find information about: 
1. What Clinoleic is and what it is used for 
2. What you need to know before using Clinoleic 
3. How to use Clinoleic 
4. Possible side effects 
5. How to store Clinoleic 
6. Contents of the packaging and other information 

1. What Clinoleic is and what it is used for

Clinoleic is an emulsion of olive oil (80%) and soybean oil (20%) for infusion .

Clinoleic is used as a source of energy and essential fatty acids (fats or lipids ) that the body cannot produce itself. Clinoleic is given directly into the bloodstream so that it does not cross the gastrointestinal tract. This method of nutrition is used when solid and liquid foods cannot be ingested due to medical reasons.

2. What you need to know before using Clinoleic

Do not use Clinoleic

  • if you are allergic to eggs, soy or peanut protein or any of the other ingredients of this medicine (listed in section 6)
  • if you have a high level of fat in your blood (severe dyslipidemia )
  • if you have an uncorrected metabolic disorder including lactic acidosis and uncontrolled diabetes .

Warnings and cautions

Special treatment monitoring is required at the beginning of each intravenousinfusion . The infusion must be stopped immediately if you get any abnormal signs or symptoms of an allergic reaction . These symptoms include sweating, fever, chills, headache, rash or difficulty breathing. This medicine contains soybean oil and egg phospholipids. Soybean protein and egg protein can cause hypersensitivity reactions. Cross-allergic reactions between soybean protein and peanut protein have been observed.

Your doctor will monitor and monitor your triglyceride levels (a type of fat found in the blood) and your blood sugar levels.

Some medicines and diseases can increase the risk of developing an infection or sepsis (bacteria in the blood). There is a particular risk of infection or sepsis when a tube ( intravenous catheter ) is inserted into a vein. Your doctor will monitor you closely for any signs of infection . Patients who need parenteral nutrition (nutrition via a tube in a vein) may find it easier to develop an infection due to their medical condition. The use of “aseptic technology” (bacteria-free technology) when the catheter is placed and maintained and when the nutrient solution is prepared can reduce the risk of infection.

Liver disease has been reported in patients receiving intravenous nutritional therapy. If you get symptoms such as nausea, vomiting, stomach pain, yellowing of the skin or eyes, contact a doctor immediately.

Your doctor should know the following:

  • serious conditions that affect your body’s ability to handle sugar, fats, proteins or salt (metabolic disorders)
  • severe blood infection ( sepsis )
  • severe liver disease
  • blood clotting disorders
  • heart attack ( myocardial infarction )
  • heart failure
  • kidney failure
  • reduction of red blood cells ( anemia )
  • fluid in the lungs.

If you become swollen, tender and red where the needle is inserted into one of the blood vessels (veins), you should contact a doctor as it may be a sign of inflammation( thrombophlebitis ).

Your doctor will monitor your condition at the beginning of the infusion , especially if you already have liver, kidney, adrenal , heart or circulatory problems.

To check the effect and continuously monitor that the medication is taking place safely, the doctor will perform clinical and laboratory tests while you are receiving this medicine.

Children and young people

Clinoleic can be used in young children if the treatment is closely monitored. Clinoleic has been used for up to seven days for newborns and for up to two months for children.

When used to treat newborns and children under 2 years of age, emulsion one (in sachets and administration sets) should be protected from light exposure until administration is complete. If Clinoleic is exposed to ambient light, especially after the addition of trace elements and / or vitamins , peroxides and other degradation products are formed, which can be reduced if the product is protected from light exposure.

Other medicines and Clinoleic

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The olive and soybean oils available in Clinoleic include K vitamin . This does not normally affect blood thinners ( anticoagulants ) such as coumarin. However, tell your doctor if you are taking blood-thinning medicines.

Pregnancy and breastfeeding

The safety of Clinoleic given during pregnancy and lactation has not been established. Therefore, you should not be treated with Clinoleic if you are pregnant or breast-feeding unless special consideration has been given by your doctor.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

3. How to use Clinoleic

Clinoleic contains 200 mg / ml lipids .

Your doctor will prescribe the dose and speed of administration.

Dosage

Use for adults

Your doctor will decide on a dose depending on your needs. Dose one is 1 to a maximum of 2 grams of lipids per kilogram of body weight and day.

Use for children

It is recommended not to exceed a daily dose of 3 grams of lipid per kilogram of body weight.

Use in premature infants and low birth weight infants

The use of Clinoleic is limited to premature infants born after at least 28 weeks of pregnancy.

A daily dose of 2.0 g lipids / kg should not be exceeded.

Method of administration and method of administration

You will receive Clinoleic through a plastic tube and cannula directly into a vein ( intravenous infusion ).

When used to treat newborns and children under 2 years of age, emulsion one (in sachets and administration sets) should be protected from exposure to light until administration is completed (see section 2).

If you use more Clinoleic than you should 

An overdose of Clinoleic can cause a decrease in your body’s ability to remove lipid s (fat overload syndrome). This effect usually resolves when the infusion of Clinoleic is discontinued (see also section 4, Possible side effects ).

If your doctor or nurse forgets to give you Clinoleic

You should not receive a double dose to make up for a forgotten dose .

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

If you notice any abnormal change at the beginning of infusion one, it should be stopped immediately. These symptoms include sweating, chills, headache and difficulty breathing.

Other side effects that occur more or less frequently have been observed:

The following side effects are common (affects 1 to 10 users in 100) :

  • elevated blood sugar level ( hyperglycaemia )
  • nausea, vomiting
  • lowered blood pressure

The following side effects are uncommon (affects 1 to 10 users in 1,000):

  • decreased white blood cell count ( leukopenia )
  • difficulty breathing ( dyspnoea )
  • swollen stomach (distended abdomen) or pain and discomfort in the area around the abdomen
  • yellowing of the skin and eyes caused by problems with the gallbladder (cholestasis) or elevated levels of bilirubin
  • Increased levels of liver enzymes or triglycerides are in your blood

The following adverse reactions have also been reported with unknown frequency (cannot be calculated from the available data):

  • reduction in the number of platelets in the blood
  • overindulge
  • allergic reactions including red itchy skin ( urticaria ), itching
  • diarrhea

If you have a reduced ability to remove fats that are part of Clinoleic, it can lead to a “fat overload syndrome”. This can be caused by an overdose of Clinoleic, but it can also occur at the beginning of an infusion even if Clinoleic is given according to instructions. The condition is associated with a sudden deterioration of the patient’s general condition. Fat overload syndrome can result in the following:

  • Excessively high level of lipids in the blood
  • fever
  • fat infiltration in the liver
  • enlarged liver ( hepatomegaly )
  • decreased number of red blood cells ( anemia )
  • a decrease in the number of white blood cells and platelets
  • problems with the blood’s ability to coagulate
  • deep unconsciousness ( coma )All of these symptoms usually go away when the infusion is stopped.

Reporting of side effects

If you get any 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 directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Clinoleic

Keep this medicine out of the sight and reach of children.

When used to treat newborns and children under 2 years of age, emulsion one (in sachets and administration sets) should be protected from exposure to light until administration is completed (see section 2).

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Do not freeze.

Store in the outer bag.

Store in the original package. Moisture sensitive.

Do not use Clinoleic if the package is damaged or if the emulsion is not homogeneously milky.

Partially used packaging must be discarded. Any remaining emulsion should not

reused but destroyed by healthcare professionals.

An oxygen-absorbing small bag / oxygen indicator is placed inside the outer bag. Before opening the outer bag, check the color of the oxygen indicator attached to the oxygen-absorbing small bag. It must match the reference color next to the OK symbol and shown on the indicator label. The indicator should be discarded when the outer bag is removed.

Used immediately after opening.

Do not use the product if the color of the oxygen indicator does not match the reference color.

Do not save an opened bag for later use.

6. Contents of the packaging and other information

Content declaration

The active substances are per 100 ml of infusion solution , emulsion

Refined olive oil (80%) and refined soybean oil (20%) ………………….. 20.00 g

corresponding to a content of essential (essential) fatty acids …………..4,00 g

Energy content …………………………………………. ………………………………….. 2000 kcal / l (8.36 MJ / l)

Osmolarity …………………………………………. ……………………………………… 270 mOsm / l

pH …………………………………………. ………………………………………….. ……… 6 – 8

Density…………………………………………. ………………………………………….. 0.986

The other ingredients are egg phospholipids, glycerol , sodium oleate, sodium hydroxide, water for injections.

Phospholipids give 47 milligrams or 1.5 mmol of phosphorus per 100 ml.

What the medicine looks like and the contents of the pack

Clinoleic is a milky homogeneous liquid.

Clinoleic is supplied in a plastic bag.

100 ml: 10 and 24 plastic bags

250 ml: 10 and 20 plastic bags

350 ml: 10 and 12 plastic bags

500 ml: 10 and 12 plastic bags

1000 ml: 6 plastic bags

1 plastic bag with 100 ml, 250 ml, 350 ml, 500 ml or 1000 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Baxter Medical AB

Box 63

164 94 Kista 

Manufacturer 

Baxter SA

Boulevard ReneBranquart 80

B-7860 Lessines

Belgium

Muhammad Nadeem

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