"As required by the bipartisan FDA Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration today proposed a rule that would require the largest food businesses in the United States and abroad to take steps to prevent facilities"...
Liposyn III Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of infection (e.g., fever, persistent sore throat), pain/swelling/redness at injection site, pain/swelling/redness of arms/legs, bluish skin, sudden weight gain, shortness of breath, back/chest pain.
Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes, bone pain, muscle weakness, yellowing skin/eyes, dark urine, easy bruising/bleeding, severe stomach/abdominal pain, trouble breathing.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Liposyn III (intravenous fat emulsion) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning section.
Before receiving the fat emulsion, tell your doctor or pharmacist if you are allergic to it; or to eggs, safflower oil, or soy/peanut found in some brands; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This product should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: high fat (lipid) levels in the blood.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.
Kidney function declines as you grow older. This medication contains aluminum, which is removed by the kidneys. Therefore, elderly people may be at greater risk for bone pain and mental/mood changes while using this drug.
Kidney function is not fully developed in newborns and infants. This medication contains aluminum, which is removed by the kidneys. Therefore, newborns and infants may be at greater risk for bone pain and mental/mood changes while using this drug.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Additional Liposyn III Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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