VACCINIA IMMUNE GLOBULIN INTRAVENOUS (HUMAN) (Systemic)

Some commonly used brand names are:

In the U.S.?

• Vaccinia Immune Globulin Intravenous

Category

• Immunizing agent (passive)

Description

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

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For vaccinia immuneglobulin intravenous (human), the following should be considered:

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

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals.

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

Children?Studies on this medicine have been done only inadult patients, and there is no known specific information comparing use ofvaccinia immune globulin intravenous (human) in children with use in otherage groups.

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingvaccinia immune globulin intravenous (human), it is especially important thatyour 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 medicalproblems 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 forserious side effects

• Immunoglobulin A (IgA) deficiency?Increased risk for allergicreaction

Proper Use of This Medicine

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

Report all infections thought to have been possiblytransmitted by this product by having your doctor call Cangene Corporationat 1-877-CANGENE.

Dosing?The dose of vaccinia immune globulin intravenous(human) will be different for different patients. The following informationincludes 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 yourdoctor.
    • Children?Use and dose must be determined by your doctor.

Precautions While Using This Medicine

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

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Check with your doctorimmediately 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 colorof 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 froma lying or sitting position; fatigue; general body swelling; itching; irregular heartbeats; joint or musclepain; light-colored stools; loss of appetite; loss of bladder control; loss of consciousness; muscle spasmor jerking of all extremities; nausea or vomiting; no blood pressure or pulse; noisy breathing; nosebleeds; not breathing; pain in chest, groin, or legs, especiallythe 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; suddenloss 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 orskin

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 themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome.

More common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; eye disorders; energy increased; feeling unusuallycold; feeling hot; lackor loss of strength; lip dry; muscle pain; shakiness in legs, arms, hands, feet; shivering; trembling orshaking of hands or feet

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