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1. Lipidem 200mg/Ml Emulsion For Infusion
2. Lipidem 200mg/Ml Emulsion For Infusion

_ PACKAGE LEAFLET: INFORMATION FOR THE USER

B. Braun Melsungen AG, 34209 Melsungen, Germany

Lipidem 200 mg/ml

emulsion for infusion

Medium-chain triglycerides, soya-bean oil, omega-3-acid triglycerides

In this leaflet:

1.    What Lipidem is and what it is used for

2.    Before you use Lipidem

3.    How to use Lipidem

4.    Possible side effects

5.    How to store Lipidem

6.    Further information

1. WHAT LIPIDEM IS AND WHAT IT IS USED FOR_

Lipidem is an emulsion of oils in water. The oils contained in Lipidem are foodstuffs. They provide energy and contain an essential nutrient, the essential fatty acids omega-6 and omega-3.

Lipidem is used to provide fat to adult patients needing to be fed by an intravenous drip, because they are unable to eat food normally or the normal intake is not enough.

2. BEFORE YOU USE LIPIDEM_

Do not use Lipidem

if one or more of the following conditions are present:

•    allergy to egg, fish, or soya-bean protein or to any of the ingredients of the emulsion, see section 6. "Further information".

•    abnormally high blood fat level (severe hyperlipidaemia)

•    conditions where the blood does not clot properly (severe blood coagulation disorders)

•    impaired bile flow (intrahepatic cholestasis)

•    severe liver failure

•    severe kidney failure without access to treatment with an artificial kidney (haemofiltration or dialysis)

•    acute phase of heart infarction (heart attack) or stroke

•    acute blocking of blood vessels by blood clots or fat drops (thromboembolic disease, lipid embolism)

Patients should generally not receive intravenous drip (infusion therapy) if one or more of the following conditions are present:

•    severely impaired blood circulation, accompanied by massive impairment of heart function, breathing, kidney and liver function, i.e. states of collapse or shock

•    unstable metabolism, for example because of severe injury, diabetes mellitus, blood poisoning (sepsis, an infection involving the whole body) or abnormally high level of acidic substances in the blood (acidosis)

•    water in the lungs (acute pulmonary oedema)

•    excess water in the body (hyper hydration)

•    heart failure (decompensated cardiac insufficiency)

•    too low water and salt level in the body (hypotonic dehydration)

•    too low potassium level in the blood (hypokalaemia).

Special care will be taken with Lipidem

Before this product is given to you, your doctor will check whether or not you have one or more of the following conditions, in which the body may not be able to use fat correctly:

•    diabetes mellitus

•    inflammation of the pancreas (pancreatitis)

•    impaired liver or kidney function

•    lung disease

•    reduced activity of the thyroid gland (hypothyroidism)

•    blood poisoning (sepsis)

If you have any of these conditions, Lipidem will only be administered if clearly needed and special care will be taken to make sure this product will not be harmful to you.

Blood sampling

If you have a disorder of blood clotting or you are lacking vitamin Ki the clotting of your blood will be checked by taking blood samples.

To make sure that the fat emulsion is taken up by the body tissues from the blood circulation and is used properly, blood samples will be taken and examined in a laboratory. The amount and rate of infusion of the fat emulsion will be adjusted accordingly.

Blood samples will also be taken frequently to check and make sure that there are no changes in the composition of your blood or in your liver function while you are receiving this product.

Combination with other solutions for intravenous feeding Lipidem infusions will not be given alone but always together with sufficient amounts of amino acids and carbohydrate (normally glucose) infusions. This helps to avoid an accumulation of some acidic substances (ketones) in your blood, which might make your blood acidic (acidosis).

Allergic reactions

If there is any sign of allergic reaction, e. g. fever, shivering, rash or dyspnoea (shortness of breath), the infusion should be discontinued.

Taking or using other medicines

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

Lipidem may interact with some other medicines. Please tell your doctor if you are taking medicines that prevent undesirable blood clotting (anticoagulants). It may be necessary to check the clotting of your blood by taking regular blood samples.

Pregnancy or breast-feeding

If you are pregnant you will receive this medicine only if the doctor considers it absolutely necessary for your recovery. There is no data about the use of Lipidem in pregnant women.

Consideration should be given to stopping breast-feeding while under treatment with Lipidem since there is no data on the use of this medicine in nursing mothers. Ask your doctor for advice if you are breast-feeding.

Driving and using machines

You will receive this medicine in a controlled setting, i.e. a hospital or under any other kind of medical supervision, which normally excludes driving or using machines.

Important information about some of the ingredients of Lipidem

Lipidem contains 2.6 mmol/l sodium. This should be taken into consideration by patients on a controlled sodium diet.

BBRAUN

3. HOW TO USE LIPIDEM_

Your doctor will decide how much of this medicine you need and for how long you will require treatment with this medicine.

The daily doses will be adjusted to your needs and body weight. The doses are normally calculated on a "gram of fat per kg body weight" basis. Care will be taken that the doses and infusion rates used, are correct for you, so your body's capacity to use the infused fat will not be exceeded.

Adults

A normal dose is 5 - 10 ml of Lipidem per kg body weight per day and the infusion will be given at the lowest possible rate.

Children and adolescents

The safe and effective use of Lipidem in children and adolescents has not been established.

How long may Lipidem be given?

Lipidem will normally be given over a period of 1 week.

Lipidem may be given for a longer time if thought necessary by your doctor. Under these circumstances, you will be carefully monitored.

How is Lipidem given?

Lipidem will be given by an intravenous drip as part of a feeding programme. For this purpose a tube (catheter) will be inserted into a vein, through which the fat emulsion can either be given separately or together with other fluids.

If you received more Lipidem than you should

If you have received too much Lipidem you may suffer from a so-called 'fat overload syndrome'. This fat overload syndrome may also be associated with some concurrently existing disorders like infections or kidney disease.

Symptoms of the fat overload syndrome may include:

•    high levels of fat in the blood

•    fever

•    deposition of fat in the liver or other organs

•    swelling of the liver, which may sometimes be accompanied by jaundice

•    swelling of the spleen

•    low levels of red blood cells, white blood cells and platelets

•    disorder of blood clotting

•    destruction of red blood cells and other blood abnormalities

•    abnormal liver function tests

•    loss of consciousness.

Marked overdose of fat emulsions may also lead to high level of acidic substances in the blood (acidosis).

If this happens, the infusion of Lipidem will be stopped immediately. Your doctor will decide on any additional treatment to be given. The infusion will not be started again until you have recovered. It may be necessary to make changes to the daily fat doses. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS_

Like all medicines, Lipidem can cause side effects, although not everybody gets them. However, if the dosage instructions and the other instructions for use are observed, most of the side effects will occur only very rarely.

If you experience the following, contact your doctor or hospital immediately.

Very rare (affecting less than 1 treated patient in 10,000):

•    allergic reactions

•    increased tendency of your blood to clot (hypercoagulation)

•    breathing problems, cyanosis (bluish discoloration of the skin)

•    fat overload syndrome.

As soon as a fat overload syndrome appears the fat infusion must be stopped. (See section 3, "If you receive more Lipidem than you should".)

Other side effects include

Very rare (affecting less than 1 treated patient in 10,000):

•    drowsiness

•    drop or raise of blood pressure

•    high blood fat and blood sugar levels, acidosis (These may occur more frequently when high lipid doses are applied.)

•    feeling sick, vomiting

•    headache

•    flushing

•    fever

•    sweating

•    chills

•    chest and back pain

If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE LIPIDEM_

Keep out of the reach and sight of children.

Do not use Lipidem after the expiry date which is stated on the label and the outer carton. The expiry date refers to the last day of that month.

After first opening Lipidem should be used immediately.

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light.

Do not freeze. Products that have been frozen will be discarded.

Do not use Lipidem if you notice:

•    large oil drops in the emulsion or two separate layers of fluid

•    discoloration

•    damage of the container or the closure.

6. FURTHER INFORMATION

What Lipidem contains

- The active substances in 1000 ml of Lipidem are:

Medium-chain triglycerides    100.0    g

Soya-bean oil, refined    80.0    g

Omega-3-acid triglycerides    20.0    g

This gives the following content of essential fatty acids per litre: Linoleic acid (omega-6)    38.4 - 46.4 g

Alpha-linolenic acid (omega-3)    4.0 - 8.8 g

Eicosapentaenoic acid and

docosahexaenoic acid (omega-3)    8.6    - 17.2 g 200 mg/ml (20%) correspond to total content of triglycerides.

-    The other ingredients are glycerol, egg lecithin, all rac-a-tocopherol, ascorbyl palmitate, sodium oleate, sodium hydroxide for pH adjustment and water for injections.

-    The amount of energy supplied per litre of Lipidem is 7900 kJ (1910 kcal).

What Lipidem looks like and contents of the pack

Lipidem is a milky white, sterile emulsion for infusion (for administration by a venous drip)

It is supplied in

•    glass bottles, pack sizes:

10 x 100 ml, 1 x 250 ml, 10 x 250 ml, 1 x 500 ml, 10 x 500 ml, 1 x 1000 ml, 6 x 1000 ml

•    plastic bags, pack sizes:

1 x 250 ml, 10 x 250 ml, 1 x 500 ml, 10 x 500 m, 1 x 1000 ml, 10 x 1000 ml Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

B. Braun Melsungen AG,

Carl-Braun-Strasse 1    Postal address

34212 Melsungen, Germany    34209 Melsungen, Germany

This leaflet was last approved in 2010-04-23

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:

Instruction for handling

Lipidem is supplied in containers for single use.

Products that have been frozen and unused residues must be discarded.

Only use if the emulsion is homogeneous from intact containers. Inspect the emulsion visually for phase separation prior to administration.

The emulsion should always be brought to room temperature prior to infusion.

If filters are used, these must allow the lipids (fat droplets) to pass through.

Before infusing a lipid emulsion together with other solutions via a Y connector or bypass set (equipment that may be used to give this product together with other solutions), the compatibility of these fluids should be checked, especially when given with carrier solutions containing other drugs. Particular caution should be taken when infusing this product with other solutions containing certain electrolytes (such as calcium).

B. Braun Melsungen AG

34209 Melsungen, Germany