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Vaccinia immune globulin, human (Intravenous route)

Pronunciation:

vax-IN-ee-a i-MUNE GLOB-ue-lin, HUE-man

Brand Names:

  • Vaccinia Immune Globulin, Human

Dosage Forms:

  • Solution

Warnings:

Intravenous route(Solution)

Immune globulin intravenous (human) (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, proximal tubular nephropathy, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable. Higher rates of renal failure were associated with IGIV products containing sucrose and administered at daily doses of 400 mg/kg or greater. Vaccinia immune globulin contains sucrose (5%) as a stabilizer, and the recommended dose is 100 mg/kg .

Classifications:

Therapeutic—

Immune Serum

Uses of This Medicine:

Vaccinia immune globulin is used to treat infections caused by the vaccinia virus.

Before Using This Medicine:

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.

Children—

Studies on this medicine have been done only in adult patients, and there is no known specific information comparing use of vaccinia immune globulin 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 in the elderly with use in other age groups.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

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.

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. 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

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 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.

Precautions While Using This Medicine:

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

Side Effects of This Medicine:

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:

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
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 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.


Last Updated: 11/4/2014

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