Fat emulsion, fish oil, and soybean oil (Intravenous)

Fat emulsion, fish oil, and soybean oil combination injection helps provide nutrition to patients who cannot get enough fat through their diet. The body uses fats for energy and to create substances necessary for normal functions.

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

It is very important for your doctor to monitor you or your child's progress closely while receiving this medicine. This helps the doctor determine if the medicine is effective. Blood and urine tests will be necessary to check for any unwanted effects.

This medicine may lead to parenteral nutrition-associated liver disease (PNALD). This typically happens in patients who have been on parenteral nutrition for a long time, especially in pre-term infants. Contact your doctor immediately if you experience 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 yellowing of the eyes or skin.

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

This medicine may lead to a rare condition known as fat overload syndrome. Inform your doctor immediately if you or your child have a fever, chills, cough, sore throat, pain and fullness in the upper right abdomen or stomach, or unusual bleeding, bruising, or weakness.

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

This medicine may increase your risk of developing infections. Avoid close contact with sick people while you or your child are receiving this medicine. Wash your hands frequently. Inform your doctor if you have any type of infection before starting this medicine. Also, tell your doctor if you have ever had an infection that did not go away or one that kept returning.

Call your doctor immediately if you or your child develop a persistent cough, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally unwell. These may indicate an infection.

This medicine may cause aluminum toxicity (too much aluminum in the blood), which can harm the brain and may be life-threatening. Discuss any concerns with your doctor.

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

Do not take other medicines unless you have talked about them with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will need to consider the risks of taking the medicine compared to the benefits it may provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care 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

Studies have not shown any specific problems in children that would limit the use of fat emulsion injection, fish oil, and soybean oil combination injection. However, children may have a higher risk of kidney problems, which may require caution when using this medicine.

Geriatric

Studies have not indicated any specific problems in the elderly that would limit the use of fat emulsion injection, fish oil, and soybean oil combination injection. However, elderly patients may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are not enough studies in women to determine if there is any risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if there is a chance of an interaction. If you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant and may not include all possible interactions.

Using this medicine with any of the following is usually not recommended, but may be necessary in some situations. If both are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about combining your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Allergy to egg, fish, soybean, or peanut proteins—Should not be used in patients with these allergies.

• Hypertriglyceridemia (high triglycerides in the blood)—Should not be used in patients with this condition.

• Diabetes or
• Metabolic disorder or
• Obesity—Use with caution. May increase risk of developing hypertriglyceridemia.

• Infection—May decrease your body's ability to fight infections.

• Kidney disease—Using this medicine for a long time in preterm infants may increase the risk of aluminum toxicity.

• Severe undernourishment—May cause refeeding syndrome. Monitor and gradually increase nutrient intake for these patients.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Blurred vision
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• nausea
• sweating
• trouble breathing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting

Less common

• Bladder pain
• bloody or cloudy urine
• chills
• confusion
• difficult, burning, or painful urination
• dizziness
• fainting
• fever
• frequent urge to urinate
• headache
• lower back or side pain
• nervousness
• pale skin
• pounding in the ears
• rapid, shallow breathing
• slow or fast heartbeat
• unusual bleeding or bruising

Rare

• Chest pain or tightness
• changes in skin color
• clay-colored stools
• cough
• dark urine
• eye pain
• general feeling of illness
• itching, skin rash
• loss of appetite
• pain, tenderness, or swelling of the foot or leg
• sneezing
• sore throat
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• blue lips, fingernails, or skin
• bluish color
• chest tightness
• confusion
• difficulty in swallowing
• irregular heartbeat
• muscle cramps, pain, or tremors
• numbness, tingling, pain, or weakness in the hands or feet
• pinpoint red spots on the skin
• problems with bleeding or clotting
• restlessness
• sores, ulcers, or white spots on the lips or in the mouth
• stomach cramps
• swelling of the face, throat, or tongue
• swollen glands
• trouble breathing
• upper right abdominal or stomach pain and fullness

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. Additionally, your health care professional may be able to tell you how 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

• Acid or sour stomach
• belching
• bloated
• excess air or gas in the stomach or intestines
• full feeling
• heartburn
• indigestion
• passing gas
• stomach discomfort or upset

Rare

• Change in taste
• loss of taste

Incidence not known

• Increased sweating

Other side effects not listed may also happen 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.