CNJ-016 Solution for injection (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Emergent BioSolutions Canada Inc.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

BOXED WARNING SECTION

WARNING:INTERACTIONS WITH GLUCOSE MONITORING SYSTEMSM Blood glucose measurement in patients receiving VIGIV must be done with a glucose-specific method (monitor and test strips) to avoid interference ...

1. Indications and Usage

VIGIV (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following conditions: Eczema vaccinatum Progressive vaccinia Severe generalized vaccinia Vaccinia ...

2. Dosage and Administration

For intravenous use only. 2.1 Dosage for Treatment of Severe Complications of Vaccinia Vaccination Administer VIGIV at a dose of 6000 Units per kg, as soon as symptoms appear and are judged to be ...

3. Dosage Forms and Strengths

Solution of gamma globulin (5% or 50 mg/mL) 20 mL single-dose vial containing antibodies to vaccinia virus at ≥50,000 Units per vial

4. Contraindications

VIGIV is contraindicated in: Isolated vaccinia keratitis. Individuals with a history of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of this or other human ...

5. Warnings and Precautions

5.1 Hypersensitivity Severe immediate hypersensitivity reactions to plasma-derived products may occur, for example, in patients with IgA deficiency or hypersensitivity to human globulin. Although acute ...

6. Adverse Reactions

The adverse reactions to VIGIV treatment in clinical trials (>10%) include headache, nausea, rigors and dizziness.

6.1. Clinical Trials Experience

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 another ...

7. Drug Interactions

7.1 Live, Attenuated Vaccines Immune globulin administration may impair the efficacy of live attenuated vaccines such as measles, rubella, mumps and varicella. Defer vaccination with live virus vaccines ...

8.1. Pregnancy

Risk Summary There are no data on the use of VIGIV in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted with VIGIV.

8.3. Nursing Mothers

Risk Summary There are no data to assess the presence or absence of VIGIV in human milk, the effects on the breastfed child or the effects on milk production/excretion.

8.4. Pediatric Use

Safety and effectiveness in the pediatric population (<16 yrs of age) has not been established for VIGIV.

8.5. Geriatric Use

Safety and effectiveness in the geriatric population (>65 yrs of age) has not been established for VIGIV.

11. Description

VIGIV is a solvent/detergent-treated, filtered sterile solution of purified gamma globulin (IgG) fraction of human plasma containing antibodies to vaccinia virus. It is stabilized with 10% maltose and ...

12.1. Mechanism of Action

VIGIV provides passive immunity for individuals with complications to vaccinia virus vaccination. The exact mechanism of action is not known.

12.2. Pharmacodynamics

Two double-blind pharmacodynamic studies were conducted in which 82 healthy volunteers were randomized to receive vaccinia vaccination with or without VIGIV. In the first study, the efficacy of 9000 Units ...

12.3. Pharmacokinetics

A double-blind study was conducted in which 60 healthy subjects were randomized to receive either 6000 Units per kg or 9000 Units per kg VIGIV. After intravenous administration of 6000 Units per kg to ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, genotoxicity and fertility studies have not been conducted with VIGIV.

13.2. Animal Toxicology and/or Pharmacology

The efficacy of VIGIV against vaccinia virus in a mouse-tail lesion model was assessed. A range of doses of VIGIV and a previously licensed VIG were compared for their ability to reduce pox formation in ...

14. Clinical Studies

The pharmacokinetic, pharmacodynamic and safety profiles of VIGIV were evaluated in three clinical trials. In these clinical studies, VIGIV was shown to have an acceptable safety profile when administered ...

15. References

1. Kahwaji J et al., Acute Hemolysis after High-Dose Intravenous Immunoglobulin Therapy in Highly HLA Sensitized Patients. Clin J Am Soc Nephrol. 2009 December 4;1993–97. 2. Daw Z, Padmore R, Neurath D, ...

16.1. How Supplied

The product is supplied as a 20 mL single dose vial containing ≥50,000 Units per vial. It is packaged in a shelf carton with 24 vials and four package inserts. NDC 60492-0173-1 VIGIV does not contain natural ...

16.2. Storage and Handling

Product may be stored frozen at or below 5°F (≤ -15°C) or refrigerated at 36 to 46°F (2 to 8°C); refer to label for appropriate storage conditions. Do not use after expiration date. If product is received ...

17. Patient Counseling 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 ...