VARIZIG Solution for injection (2018)
Βιβλιογραφική αναφορά
Συγγραφείς
Cangene BioPharma
Λέξεις κλειδιά
53270-0126
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1. Indications and Usage
VARIZIG [Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include: immunocompromised children and adults, newborns ...
2. Dosage and Administration
For intramuscular use only. 2.1 Preparation and Handling Each vial of VARIZIG contains a minimum potency of 125 IU in 1.2 mL. Bring VARIZIG to room temperature prior to use. Inspect VARIZIG for particulate ...
3. Dosage Forms and Strengths
VARIZIG is supplied as a sterile solution for intramuscular injection and is available in a single-use vial of 125 IU. Each 125 IU vial of VARIZIG contains less than 156 milligrams of total protein, mostly ...
4. Contraindications
Individuals known to have anaphylactic or severe systemic (hypersensitivity) reactions to human immune globulin preparations should not receive VARIZIG. IgA-deficient patients with antibodies against IgA ...
5. Warnings and Precautions
5.1 Thrombotic Events Thrombotic events may occur during or following treatment with immune globulin products (1,2,3). Patients at risk include those with a history of atherosclerosis, multiple cardiovascular ...
6. Adverse Reactions
The most serious adverse drug reactions observed in clinical trials for all subjects and patients (n=601) include pyrexia, nausea, and vomiting. The most common adverse drug reactions (reported by ≥1% ...
6.1. Clinical Trials Experience
<em>Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of ...
7. Drug Interactions
The passive transfer of antibodies with immune globulin administration may impair the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella. Defer vaccination with live ...
8. Use in Specific Populations
8.6 Immunocompromised Patients In the EAP, both adult (n=37) and pediatric immunocompromised subjects (n=235) were treated. Twelve immunocompromised subjects developed clinical varicella and none developed ...
8.1. Pregnancy
Pregnancy category C. Animal reproduction studies have not been conducted with VARIZIG. It also is not known whether VARIZIG can cause fetal harm when administered to a pregnant woman or can affect reproduction ...
8.3. Nursing Mothers
It is not known whether VARIZIG is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VARIZIG is administered to a nursing mother.
8.4. Pediatric Use
The dosing recommendations in the treatment of pediatric patients are by body weight [see 2 DOSAGE AND ADMINISTRATION]. The safety and effectiveness of VARIZIG have been evaluated for post-exposure prophylaxis ...
8.5. Geriatric Use
Clinical studies of VARIZIG administered intramuscularly for post-exposure prophylaxis did not include sufficient numbers of geriatric subjects (aged 65 and over) to determine whether they respond differently ...
10. Overdosage
Manifestations of an overdose of VARIZIG administered intramuscularly are expected to be pain and tenderness at the injection site.
11. Description
VARIZIG [Varicella Zoster Immune Globulin (Human)] is a solvent/detergent-treated sterile liquid preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus (anti-VZV). ...
12.1. Mechanism of Action
VARIZIG provides passive immunization for non-immune individuals exposed to VZV, reducing the severity of varicella infections (5).
12.3. Pharmacokinetics
In a comparative pharmacokinetic clinical trial, 35 volunteers were administered an intramuscular dose of 12.5 IU/kg of VARIZIG (n=18) or the comparator product VZIG (n=17). The dose of 12.5 IU/kg of VZIG ...
14. Clinical Studies
14.1 Pregnant Women Exposed to Varicella Zoster Virus A randomized, open-label, multicenter, active controlled clinical trial was conducted in 60 pregnant women without immunity to VZV as confirmed by ...
15. References
Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology. 1994; 44:223-6. Woodruff RK, Grigg AP, Firkin FC, Smith IL. Fatal thrombotic ...
16.1. How Supplied
NDC 53270-0126-2: VARIZIG [Varicella Zoster Immune Globulin (Human)] is supplied as a sterile liquid approximately 125 IU of anti-VZV in a 3 mL type 1 glass tubing vial fitted with a 13 mm rubber stopper ...
16.2. Storage and Handling
Store VARIZIG at 2 to 8°C (36 to 46°F). Do not freeze. Do not use after expiration date.
17. Patient Counseling Information
Inform patients of the following: VARIZIG is intended to reduce the severity of chickenpox infections. Please see your doctor if you develop the signs and symptoms of varicella. VARIZIG is prepared from ...