Fibrinogen Intravenous

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 fibrinogen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fibrinogen 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fibrinogen injection in children.

Geriatric

Appropriate studies on the relationship of age to the effects of fibrinogen injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

Pregnancy

Breast Feeding

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.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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.

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:

• Fever

• Anxiety
• chest pain or discomfort
• chills
• cough
• difficult or labored breathing
• difficulty with swallowing
• dizziness or lightheadedness
• fainting
• fast heartbeat
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, redness, or swelling in the arm or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe headaches of sudden onset
• skin rash, hives, or itching
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• sweating
• tightness in the chest
• unusual tiredness or weakness
• vomiting

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:

• Headache

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.

Consult your pharmacist.

How to use Fibrinogen Solution, Reconstituted (Recon Soln)

Consult your pharmacist.

Consult your 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.