Vaccinia Immune Globulin Human

Vaccinia immune globulin is used to treat infections caused by the vaccinia virus. This product is available in the following dosage forms: Solution.

Before using Vaccinia immune globulin human, you must know all about the risks and complications associated with it. 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 Population: Studies on this medicine have been done only in adult patients, and there is no known specific information comparing the use of vaccinia immune globulin in children with use in other age groups.

Geriatric Population: 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 the use of vaccinia immune globulin in the elderly with use in other age groups.

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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:

• 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.

To use Vaccinia immune globulin human properly, you must follow all instructions given by your doctor. Make sure you discuss the risks and benefits of this medicine 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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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.

In using Vaccinia immune globulin human, you must be careful and take some precautions as advised by your doctor. Tell your healthcare provider if you have ever had a reaction to a vaccination.

Make sure you meet with your doctor in using Vaccinia immune globulin human to avoid unwanted potential side 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:

Incidence Unknown:

• Fever
• Headache
• Nausea
• Stiff neck or back

Observed postmarketing:

• Back, leg or stomach pain
• 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 produces a pink frothy sputum
• Dark urine
• Decreased urination
• Diarrhea
• Difficult 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 spasms 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
• 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

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:

• burning, crawling, itching, numbness, prickling, "pins and needles" or tingling feelings
• eye disorder
• 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 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.