"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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Proplex-T Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Proplex T, Factor IX Complex, Heat Treated is a combination of four different clotting factors and other proteins used to treat or prevent bleeding episodes in people with hemophilia B. It is also used to control bleeding related to surgery or dentistry in people with hemophilia B. This medication may be available in generic form. Common side effects include pain at injection site, chills, tingling, flushing, headache, nausea, or vomiting.
The dose of Proplex T, Factor IX Complex required to restore normal hemostasis varies with the circumstances and with the patient. Proplex T may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Proplex T should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Proplex T, Factor IX Complex, Heat Treated Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Proplex-T in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- cough, chest pain;
- weak or shallow breathing;
- feeling short of breath;
- headache, feeling like you might pass out;
- fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- easy bruising, increased bleeding episodes; or
- bleeding from a wound or where the medicine was injected.
Less serious side effects may include:
- mild nausea or stomach pain; or
- mild tingly or jittery feeling.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Proplex-T (Factor IX Complex) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Proplex-T Overview - Patient Information: Side Effects
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 right away if you have any serious side effects, including: swelling at injection site, fast heartbeat, shortness of breath, change in the amount of urine, swelling of the ankles/feet, pain/redness/swelling of arms or legs, new or increased bleeding/bruising.
Get medical help right away if any of these rare but very serious side effects occur: chest pain, trouble breathing, bluish fingers.
This medication is made from human blood. Even though donors are carefully screened and this medication goes through a special manufacturing process, there is a very small chance that you may get infections from the medication (e.g., viral infections such as hepatitis). Tell your doctor immediately if you develop any signs of hepatitis/another infection, including fever, persistent sore throat, unusual tiredness, persistent nausea/vomiting, yellowing eyes/skin, dark urine.
A very serious allergic reaction to this drug is rare. However, get medical help right away 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 entire patient information overview for Proplex-T (Factor IX Complex)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Proplex-T FDA Prescribing Information: Side Effects
As with other plasma preparations, reactions manifested by chills and fever may occasionally be seen, particularly when large doses of PROPLEX T (factor ix complex) , Factor IX Complex, Heat Treated are administered.17,18 A rate of infusion that is too rapid may cause headache, flushing, and changes in pulse rate and blood pressure. In such instances, stopping the infusion allows the symptoms to disappear promptly. With all but the most reactive individuals, the infusion may be resumed at a slower rate. (See Rate of Administration.) The risk of thrombosis is present with the administration of PROPLEX T (factor ix complex) , Factor IX Complex, Heat Treated.
Read the entire FDA prescribing information for Proplex-T (Factor IX Complex) »
Additional Proplex-T 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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