Description
Prothrombin complex, human-lans injection is used to reverse the effects of anticoagulants or blood thinners (eg, warfarin, Coumadin®, Jantoven®) in patients who need surgery.
Prothrombin complex, human-lans contains coagulation factors II, VII, IX, and X, and proteins C and S. This medicine is used to stop bleeding by helping the blood to clot.
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
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
Appropriate studies have not been performed on the relationship of age to the effects of Balfaxar® in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Balfaxar® in the elderly.
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:
- Allergy to heparin or
- Immunoglobulin A (IgA) deficiency with antibodies against IgA or
- Thrombocytopenia (low number of platelets), heparin-induced, history of—Should not be used in patients with these conditions.
- Blood clotting problems or
- Heart disease, history of or
- Liver disease—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.
Precautions
It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a cough, difficulty with swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, trouble breathing, chest tightness, swelling in your face, hands, tongue, or throat after you receive the medicine.
Check with your doctor right away if you have blood in the stools, blood in the urine, bruising, confusion, coughing or vomiting blood, persistent bleeding or oozing from puncture sites, mouth, or nose, tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area, or trouble breathing. These may be symptoms of blood clotting problems.
This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, Creutzfeldt-Jacob disease) to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.
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 or nurse immediately if any of the following side effects occur:
More common
- Pale skin
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Rare
- Increase in blood pressure
- increase in body temperature
Incidence not known
- Blood in the urine
- blood in the stools
- blue lips, fingernails, or skin
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- bruising
- chest pain, discomfort, or tightness
- chills
- confusion
- cough
- coughing or vomiting blood
- diarrhea
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- fever
- headache
- hives, itching, skin rash
- inability to speak
- joint or muscle pain
- lightheadedness, dizziness, or fainting
- nausea
- nervousness
- no blood pressure or pulse
- numbness or tingling of the face, hands, or feet
- pain in the chest, groin, or legs, especially the calves
- persistent bleeding or oozing from puncture sites, mouth, or nose
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness or soreness of the eyes
- shakiness in the legs, arms, hands, or feet
- seizures
- severe or sudden headache
- slow or irregular heartbeat
- slurred speech
- sores in the mouth
- stomach pain
- stopping of the heart
- sudden loss of coordination
- sweating
- swelling of the feet or lower legs
- temporary blindness
- trembling or shaking of the hands or feet
- unconsciousness
- vision changes
- vomiting
- weakness in the arm or leg on one side of the body, sudden and severe
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
- Lack or loss of strength
Less common
- Redness or pain at the catheter site
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.
CON-XXXXXXXX
