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CNJ-016 (vaccinia immune globulin- human injection

  1. Patient Information
  2. Manufactured By:

Patient Information 

Discuss the risks and benefits of VIGIV with the patient before prescribing or administration.

Inform patients of the potential for hypersensitivity reactions, especially in individuals with previous reactions to human immune globulin and in individuals deficient in IgA [see4 CONTRAINDICATIONSand5.1 Hypersensitivity]. Advise patients to be aware of the following symptoms associated with allergic reactions: hives, rash, chest tightness, wheezing, shortness of breath, or feeling light headed or dizzy when they stand. Caution patients to seek medical attention immediately should they experience any one or more of the above mentioned symptoms, as well as other side effects including injection site pain, chills, fever, headache, nausea, vomiting, and joint pain.
Advise patients that the maltose contained in VIGIV can interfere with some types of blood glucose monitoring systems. Patients must use testing systems that are glucose-specific for monitoring blood glucose levels as the interference of maltose could result in falsely elevated glucose readings, which could lead to untreated hypoglycemia or to inappropriate insulin administration, resulting in life-threatening hypoglycemia [see5.2 Interference with Blood Glucose Testing].
Advise patients that VIGIV may impair the effectiveness of certain live virus vaccines such as measles, rubella (i.e. German measles), mumps, and varicella (i.e. chickenpox). Patients recently vaccinated must notify their treating physician [see7.1 Live, Attenuated Vaccines].
Inform patients that VIGIV is prepared from human plasma. Products made from human plasma may contain infectious agents such as viruses that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacturing. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products [see5.9 Transmission of Infectious Agents from Human Plasma]

Manufactured By: 

Emergent BioSolutions Canada Inc.
155 Innovation Drive
Winnipeg, MB Canada
R3T 5Y3

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