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Frequently Asked Questions

How well is Gamunex® tolerated?

Patient FAQs
Gamunex provides excellent tolerability.1 The PI trial for Gamunex reported a low incidence of adverse events.3 The trial results further showed Gamunex is well tolerated even at the higher doses required for ITP therapy.1 The most common side effects noted during the clinical trials included headache, vomiting, fever, nausea, rash, and back pain. More than 90% of those adverse events were mild to moderate and transient.
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How well is Gamunex® Purified, tolerated?

Professional FAQs
Gamunex® is well tolerated.1 The adverse event (A/E) profile in the PI study indicated a very low incidence: Based on the number of total infusions, the most common A/Es were increased cough (1.7%), pharyngitis (0.8%), headache (0.8%), fever (0.1%), nausea (0.5%), and urticaria (0.5%). Gamunex® is well tolerated even at higher doses in ITP.
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What is Gamunex®?

Professional FAQs
Gamunex® is a ready-to-use 10% sterile solution of human immune globulin protein for intravenous administration.1 The Gamunex® advanced product features and composition are rooted in a new revolutionary caprylate/chromatography-based purification process.
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Is Kytril well tolerated?

Kytril: Healthcare Professional - FAQ
Extensive research has shown that Kytril is well tolerated and can be safely used in a wide range of patient types. Furthermore, the adverse events reported with Kytril are generally mild to moderate.
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So, is there a more-or-less comprehensive list of things NOT tolerated around here?

HBO Forum FAQ's
Illegal Postings: Postings that are illegal, such as Child Pornography, drug dealing or other illegal activities, images or information are not allowed. You accept full responsibility for what you post as we cannot be held liable for the activities of others on our sites. Duplicate/Repetitive Postings: Duplicate postings with identical or similar text are not allowed. Click only ONCE on the submit button, and your posting will appear. A new page will load showing your posting.
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How was ENBREL tolerated by geriatric patients?

ENBREL - ENBREL Frequently Asked Questions
A total of 480 RA patients and 89 plaque psoriasis patients ages 65 years or older have been studied in clinical trials. No overall differences in safety or effectiveness were observed between these patients and younger patients. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
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What is inappropriate and will not be tolerated in the forum?

Free Personals, Adult Personals, Adult Photo Personals, Onli...
Sex-Match we accept you to hang loose and have fun. So, we understand that most conversation can get steamy and sexy at the same time. The only thing we ask is that you refrain from mentioning any sexual contact with animals (bestiality), also no talk of any sexual contact with a minor/child, please do not promote hate or racism of any sort.
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Q - Will unauthorized vending be tolerated?

Frequently Asked Questions
A - Unauthorized vending will not be tolerated. Our festivals require all merchants to register with us for an event permit. Selling anything without an authorized festival permit is prohibited and can result in ejection without refund. As with booth spaces, walking passes must be obtained in advance.
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What are the U.S. approved indications for Gamunex®?

Professional FAQs
Gamunex® is indicated as replacement therapy for PI states in which severe impairment of antibody-forming capacity has been shown, such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked immunodeficiency with hyper IgM, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.1 Gamunex® is indicated in ITP to rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.1
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What clinical trials were performed with Gamunex®?

Professional FAQs
We conducted the first licensure-relevant randomized, double-blind, controlled, statistically powered, head-to-head therapeutic equivalence IGIV trials for PI and ITP. The trial program included 7 trials and more than 350 patients2: The size and design of the studies have provided unprecedented proof of efficacy, safety, and tolerability. Gamimune® N, 10% was the comparator in many of these trials.2
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Are there any drug interactions with Gamunex®?

Professional FAQs
Antibodies in Gamunex® may interfere with the response to live viral vaccines such as measles, mumps, and rubella. Therefore, use of such vaccines should be deferred until approximately 6 months after Gamunex® administration.1
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How safe is Gamunex® from prions?

Professional FAQs
The manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the Creutzfeldt- Jakob disease (CJD) and vCJD agents. Several of the individual production steps in the Gamunex manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps included cloth filtration and depth filtration.
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Will supply be an issue for Gamunex®?

Professional FAQs
Consistent and reliable supply of this lifesaving therapy is of utmost importance. Talecris has addressed this issue with a variety of measures and investments: Talecris built a totally new, dedicated production facility for the manufacture of Gamunex®, a facility that meets or exceeds current Good Manufacturing Practices (cGMP) standards.
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Are Gamunex® components latex-free?

Professional FAQs
No. Caution should be exercised in patients hypersensitive or allergic to latex. As a precaution, latex-sensitive healthcare providers should use proper gloves when handling the product stopper.2
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What are the storage conditions for Gamunex®?

Professional FAQs
Gamunex® offers a long shelf life. Product may be stored for 36 months at 2°C to 8°C (36°Fâ?"46°F), and product may be stored at temperatures not to exceed 25°C (77°F) for up to 6 months anytime during the 36-month shelf life, after which the product must be immediately used or discarded. Do not freeze. Do not use after expiration date.1
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What is the recommended infusion rate of Gamunex®?

Professional FAQs
It is recommended that Gamunex® should initially be infused at a rate of 0.01 mL/kg/min (1 mg/kg/min) for the first 30 minutes. If welltolerated, the rate may be gradually increased to a maximum of 0.08 mL/kg/min (8 mg/kg/min). If side effects occur, the rate may be reduced, or the infusion interrupted until symptoms subside. The infusion may then be resumed at a rate that is comfortable for the patient.1
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Will Gamunex® be reimbursed by third-party payers?

Professional FAQs
Talecris is working with third-party payers such as Medicare, Medicaid, Federal Supply Schedule (FSS), insurance carriers, and others, to minimize possible reimbursement issues. Please consult with your specific group to determine the current status of reimbursement for Gamunex®.
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How was Gamunex® tested before the FDA approved it?

Patient FAQs
Before FDA approval of Gamunex, we conducted the largest clinical trials program ever performed for the licensure of an IGIV product. The results demonstrated the significant benefits of Gamunex, including its excellent efficacy, safety, and tolerability profile.
Related Questions

What is Gamunex® approved for in the United States?

Patient FAQs
In the United States, Gamunex is indicated as replacement therapy for PI disorders in which impairment of antibody-forming capacity has been shown, such as congenital agammaglobulinemia, a common variable immunodeficiency; X-linked immunodeficiency with hyper IgM; Wiskott-Aldrich syndrome; and severe combined immunodeficiencies.1 Gamunex also is indicated in ITP to rapidly raise platelet counts to prevent bleeding or allow a patient with ITP to undergo surgery.1
Related Questions

Is Gamunex® compatible with other IV solutions?

Patient FAQs
Gamunex is not compatible with saline. If dilution is required, Gamunex may be diluted with 5% dextrose in water (D5/W).1
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For how much longer will this brutality be tolerated?

VoyForums: Honor Bright
We strive to provide unparalled service and dedication to duty to ensure a sense of well-being and safety for the citizens of Bay County. " Like it or not, less children are being born into American families and the increase in population throughout the United States is not caused by domestic harmony and prosperity but by immigration.
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How are scars tolerated on the breast?

Dr. Ioannis Lyras. W E L C O M E
Because scars are probably the greatest drawback to aesthetic breast surgery, there is a constant effort to minimize the length of incision and to place incisions in hidden areas. Decreasing incision length, however, may limit the ability to achieve the optimal aesthetic result. Although periarcolar and intraarcolar incisions are located on the most prominent and focused position of the breast, the resultant scars are the most predictable and best tolerated.
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How is eLaser treatment tolerated by the patient?

Syneron.com - Frequently Asked Questions - eLaser
Everyone has different pain tolerances but most patients are treated without topical anesthetic creams. The chilled air device, SynerCool™ is very helpful for discomfort during treatment and especially when fast, auto-repeat firing is used for large treatment zones. Most patients find that the eLaser is more uncomfortable than the Aurora for hair removal; possibly from the higher RF energy used.
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Should bats be tolerated or encouraged in our neighborhoods?

frequently asked questions about bats and bat houses free ba...
There are clear benefits to sharing our neighborhoods with bats, but as with any wild animal, they never should be tolerated inside our living quarters. Most bats that enter living areas are lost youngsters with no greater interest than a safe escape. They can be chased out through an open door or window or caught in a butterfly net, a leather gloved hand, or a coffee can slowly placed over them while a piece of cardboard is slid between the bat and wall.
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Is the local or regional hyperthermia tolerated well?

ESHO | patients | faqs
Generally speaking, the loco-regional hyperthermia is tolerated very well and can be carried out without special medicine or other preparing measures. Typically there will be a local sensation of warmth or heat. Sometimes this sensation can increase to a feeling of discomfort or pain - if this is the case, the doctor must be immediately informed so that he can change the adjustments accordingly.
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