"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Measles, Mumps, Rubella and Varicella Virus Vaccine Live Lyophilized Preparation for Subcutaneous Injection
ProQuad (Measles, Mumps, Rubella and VaricellaVaccine Live) is a combined, attenuated, live virus vaccine containing measles, mumps, rubella, and varicella viruses. ProQuad is a sterile lyophilized preparation of (1) the components of M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live): Measles Virus Vaccine Live, a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps virus propagated in chick embryo cell culture; Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts; and (2) Varicella Virus Vaccine Live (Oka/Merck), the Oka/Merck strain of varicella-zoster virus propagated in MRC-5 cells. The cells, virus pools, bovine serum, and human albumin used in manufacturing are all tested to provide assurance that the final product is free of potential adventitious agents.
ProQuad, when reconstituted as directed, is a sterile suspension for subcutaneous administration. Each 0.5-mL dose contains not less than 3.00 log10 TCID50 of measles virus; 4.30 log10 TCID50 of mumps virus; 3.00 log10 TCID50 of rubella virus; and a minimum of 3.99 log10 PFU of Oka/Merck varicella virus.
Each 0.5-mL dose of the vaccine nominally contains 20 mg of sucrose, 11 mg of hydrolyzed gelatin, 2.5 mg of urea; 2.3 mg of sodium chloride, 16 mg of sorbitol, 0.38 mg of monosodium L-glutamate, 0.14 mg of sodium phosphate, 0.25 mg of human albumin, 0.13 mg of sodium bicarbonate, 94 mcg of potassium phosphate, 58 mcg of potassium chloride; residual components of MRC-5 cells including DNA and protein; 5 mcg of neomycin, bovine serum albumin (0.5 mcg), and other buffer and media ingredients. The product contains no preservative.17
What are the possible side effects of this vaccine (ProQuad)?
Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is...
What are the precautions when taking measles mumps rubella varicella vaccine live (Proquad)?
Before your child receives this product, tell the doctor or pharmacist if your child is allergic to it; or to eggs; or if your child has any other allergies. This product may contain inactive ingredients (such as neomycin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before receiving this product, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness (such as untreated tuberculosis), bleeding/blood clotting problems (such as hemophilia, low platelets), blood cancer (such as leukemia, lymphoma), immune system problems (such as HIV infection), scheduled organ transplant, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.
There is a small risk...
Last reviewed on RxList: 9/12/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Proquad Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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