Vaccinia Immune Globulin Intravenous (Human) (Vac-SIN-ee-a im-yoon GLOB-u-lin IN-tra-ve-nas) is used to treat infections caused by the vaccinia virus.

Vaccinia is available only with your doctor's prescription, in the following dosage forms:

• Parenteral
• Injection (U.S. and Canada)

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 vaccinia immune globulin intravenous (human), the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to vaccinia immune globulin intravenous (human) or other human immunoglobulins. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy: Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding: It is not known whether vaccinia immune globulin intravenous (human) passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking Vaccinia and who wish to breast-feed should discuss this with their doctor.

Children: Studies on Vaccinia have been done only in adult patients, and there is no known specific information comparing use of vaccinia immune globulin intravenous (human) in children with use in other age groups.

Older adults: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of vaccinia immune globulin intravenous (human) in the elderly with use in other age groups.

Other 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. When you are taking vaccinia immune globulin intravenous (human), it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Vaccines made from a live virus - Vaccinia immune globulin intravenous (human) may interfere with how well the vaccine will work

Other medical problems: The presence of other medical problems may affect the use of vaccinia immune globulin intravenous (human). Make sure you tell your doctor if you have any other medical problems, especially:

• Vaccinia keratitis - Use is not recommended

• Hyperviscosity, known or suspected - May increase chance for serious side effects

• Immunoglobulin A (IgA) deficiency - Increased risk for allergic reaction

Proper Use of Vaccinia

Make sure you discuss the risks and benefits of Vaccinia with your doctor.

Report all infections thought to have been possibly transmitted by this product by having your doctor call Cangene Corporation at 1-877-CANGENE.

Dosing: The dose of vaccinia immune globulin intravenous (human) will be different for different patients. The following information includes only the average doses of vaccinia immune globulin intravenous (human).

• For injectable dosage form:
  • For treatment and/or medical problems due to vaccinia virus:
    • Adults - Dose is based on weight and will be determined by your doctor.
    • Children - Use and dose must be determined by your doctor.

Precautions while using Vaccinia

Tell your healthcare provider if you have ever had a reaction to a vaccination.

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 immediately if any of the following side effects occur:

• Frequency unknown
  • Fever
  • headache
  • nausea
  • stiff neck or back
  • vomiting

• Observed postmarketing
  • Back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, loosening of skin
  • bluish color of fingernails, lips, skin, palms, or nail beds
  • blurred vision
  • change in consciousness
  • chest pain
  • chills
  • cold, clammy, pale skin
  • confusion
  • convulsions
  • cough
  • coughing that sometimes produces a pink frothy sputum
  • dark urine
  • decreased urination
  • diarrhea
  • difficulty or labored breathing
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • fatigue
  • general body swelling
  • itching
  • irregular heartbeats
  • joint or muscle pain
  • light-colored stools
  • loss of appetite
  • loss of bladder control
  • loss of consciousness
  • muscle spasm or jerking of all extremities
  • nausea or vomiting
  • no blood pressure or pulse
  • noisy breathing
  • nosebleeds
  • not breathing
  • pain in chest, groin, or legs, especially the calves
  • painful or difficult urination
  • red irritated eyes
  • red skin lesions, often with a purple center
  • severe, sudden headache
  • severe weakness or numbness in arm or leg
  • shortness of breath
  • slow heart rate
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots in mouth or on lips
  • stopping of heart
  • sudden loss of coordination
  • sudden
  • suddenly sweating
  • swelling in legs and ankles
  • swollen glands
  • tightness in chest
  • troubled breathing
  • unconsciousness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vision changes
  • wheezing
  • yellowing of the eyes or skin

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Vaccinia. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
  • eye disorders
  • energy increased
  • feeling unusually cold
  • feeling hot
  • lack or loss of strength
  • lip dry
  • muscle pain
  • shakiness in legs, arms, hands, feet
  • shivering
  • trembling or shaking of hands or feet

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 12/07/2005

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