Fat Emulsion (Intravenous Route, Injection Route)

Fats are used by the body for energy and to form substances needed for normal body functions.

Fat emulsions are available by injection only with your doctor`s prescription.

This product is available in the following dosage forms:

• Emulsion


• Injectable

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Fat emulsions may cause or worsen lung problems or jaundice if given to premature infants. Although there is no specific information comparing use of fat emulsions in older children with use in other age groups, it is not expected to cause different side effects or problems in older children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people . Although there is no specific information comparing use of fat emulsions in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems or


• Diabetes mellitus (sugar diabetes) or


• High cholesterol levels or


• Infection or


• Jaundice or


• Kidney disease or


• Liver disease or


• Lung disease or


• Pancreas diseasea€”Fat emulsions may make these conditions worse

Proper Use

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  
  
  • For nutritional supplement:
    
    
    
    • Adults and teenagersa€”At first, the dose is 0.5 to 1 milliliter (mL) per minute injected slowly into a vein over a period of fifteen to thirty minutes. Your doctor may increase the rate of the injection until up to 250 to 500 mL have been injected over four to six hours.
    
    
    • Childrena€”At first, the dose is 0.1 mL per minute injected slowly into a vein over a period of fifteen minutes. Your doctor may increase the rate of the injection up to 50 to 100 mL per hour.
    
    
    
    
  
  
  
  

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

It is very important that your doctor check your progress weekly while you are receiving fat emulsions to make sure that this medicine does not cause unwanted effects.

Fat emulsions can lower your ability to fight infection. If you think you are getting an infection, check with your doctor .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Chills


• Fever


• Sore throat

Rare

• Bluish color of skin


• Chest or back pain


• Difficulty in breathing


• Headache


• Hives


• Unusual bleeding or bruising


• Unusual irritability


• Unusual tiredness or weakness


• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Redness, swelling, or pain at place of injection

Less common

• Diarrhea


• Dizziness


• Flushing


• Nausea and vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.