Fat emulsion and soybean oil (Intravenous)

Fat emulsion and soybean oil combination injection is used to give nutritional support to patients who cannot get enough fat from their diet. The body uses fats for energy and to create substances that are necessary for normal body function.

This medicine should only be given by or under the direct supervision of your doctor.

It is very important that your doctor checks your or your child's progress closely while receiving this medicine. This will help your doctor see if the medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

This medicine may cause parenteral nutrition-associated liver disease (PNALD). This usually happens in patients who have received parenteral nutrition for a long time, especially pre-term infants. Contact your doctor immediately if you have chills, clay-colored stools, dark urine, diarrhea, dizziness, fever, headache, itching, loss of appetite, nausea, rash, bad breath, unusual tiredness or weakness, vomiting blood, or yellow eyes or skin.

This medicine may cause acute respiratory distress syndrome and metabolic acidosis in newborns and infants after rapid infusion. Contact your doctor immediately if your child has blue lips, fingernails, or skin, difficulty breathing, confusion, drowsiness, fast breathing, muscle tremors, nausea, restlessness, stomach cramps, or unusual tiredness or weakness.

This medicine may cause a rare condition called fat overload syndrome. Inform your doctor right away if you or your child have a fever, chills, cough, sore throat, upper right abdominal or stomach pain and fullness, or unusual bleeding, bruising, or weakness.

This medicine may cause a serious allergic reaction, which can be life-threatening and needs immediate medical attention. Inform your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or swelling of your hands, face, or mouth after using this medicine.

This medicine may increase your risk of developing infections. Avoid being around people who are sick or have infections while you or your child are receiving this medicine. Wash your hands often. Inform your doctor if you have any kind of infection before starting this medicine. Also tell your doctor if you have ever had an infection that did not go away or an infection that kept coming back.

Call your doctor right away if you or your child develop a cough that will not go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs of an infection.

This medicine may cause aluminum toxicity (too much aluminum in the blood), which can damage the brain and be life-threatening. Talk to your doctor if you have concerns.

Before you have any medical tests, inform the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks versus the benefits. For this medicine, please think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Current studies have not shown any specific problems in children that would limit the usefulness of Intralipid® 10% injection and Intralipid® 20% injection. However, children are more likely to have liver issues, which may require caution when using this medicine.

Studies have not been done on how age affects the use of Clinolipid injection in children. Safety and effectiveness have not been established for this group.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of fat emulsion injection and soybean oil combination injection. However, older adults may be more sensitive to the effects of this medicine compared to younger adults.

Breast Feeding

There are no adequate studies on the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if interactions could happen. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtimes or with certain types of food, as interactions may occur. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Allergy to egg, soybean, or peanut proteins—This medicine should not be used in patients with these allergies.

• Hyperlipidemia (high cholesterol)—This medicine should not be used in patients with this condition.

• Infection—This may reduce your body's ability to fight infections.

• Kidney disease—Long-term use in preterm babies may increase the risk of aluminum toxicity.

• Severe undernourishment—This may cause refeeding syndrome. Monitor and increase nutrient intake slowly for these patients.

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

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Blurred vision
• changes in skin color
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• nausea
• pain, tenderness, or swelling of the foot or leg
• stomach pain
• sweating
• trouble breathing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting

Less common

• Back pain
• pain or discomfort in the legs, groin, or chest
• swelling and redness in the lower leg

Rare

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• chills
• clay-colored stools
• dizziness
• fever
• headache
• itching, rash
• loss of appetite
• painful or difficult urination
• pinpoint red spots on the skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• right upper abdominal or stomach pain and fullness
• unpleasant breath odor
• unusual bleeding or bruising
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Blue lips, fingernails, or skin
• chest tightness
• confusion
• cough or hoarseness
• difficulty in breathing or swallowing
• drowsiness
• fast heartbeat
• lower back or side pain
• muscle tremors
• restlessness
• stomach cramps
• swelling of the face, throat, or tongue

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. 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:

Less common

• Dry, red, hot, or irritated skin
• feeling of warmth
• redness of the face, neck, arms and occasionally, upper chest
• sleepiness

Rare

• Redness, swelling, or pain at the injection site

Incidence not known

• Diarrhea

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.

Available Dosage Forms:

• Emulsion

Therapeutic Class: Parenteral Lipids

A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through a needle placed into one of your veins.