Dorzolamide Hydrochloride Ophthalmic Solution 2%
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Questions & Answers
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Fluzone Quadrivalent is approved for use in persons 6 months of age and older.
History
There is currently no drug history available for this drug.
Other Information
Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation.
Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color.
Antibiotics are not used in the manufacture of Fluzone Quadrivalent.
The Fluzone Quadrivalent prefilled syringe and vial presentations are not made with natural rubber latex.
Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2014-2015 influenza season: A/California/07/2009 X-179A (H1N1), A/Texas/50/2012 X-223A (H3N2), B/Massachusetts/02/2012 (B Yamagata lineage), and B/Brisbane/60/2008 (B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 6. The single-dose, pre-filled syringe (0.25 mL and 0.5 mL) and the single-dose vial (0.5 mL) are manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.
| Ingredient | Quantity (per dose) |
|
|---|---|---|
| Fluzone Quadrivalent 0.25 mL Dose |
Fluzone Quadrivalent 0.5 mL Dose |
|
| "-" Indicates information is not applicable | ||
|
||
| Active Substance: Split influenza virus, inactivated strains*: | 30 mcg HA total | 60 mcg HA total |
| A (H1N1) | 7.5 mcg HA | 15 mcg HA |
| A (H3N2) | 7.5 mcg HA | 15 mcg HA |
| B/(Victoria lineage) | 7.5 mcg HA | 15 mcg HA |
| B/(Yamagata lineage) | 7.5 mcg HA | 15 mcg HA |
| Other: | ||
| Sodium phosphate-buffered isotonic sodium chloride solution | QS† to appropriate volume | QS† to appropriate volume |
| Formaldehyde | ≤50 mcg | ≤100 mcg |
| Octylphenol ethoxylate | ≤125 mcg | ≤250 mcg |
| Preservative | ||
| Single-dose presentations | - | - |
| Multi-dose presentation (thimerosal) | 12.5 mcg mercury | 25 mcg mercury |
Sources
Dorzolamide Hydrochloride Ophthalmic Solution 2% Manufacturers
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Alvogen Inc.
![Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10ml Ophthalmic Solution 2%, 10ml (Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10ml) Solution [Alvogen Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dorzolamide Hydrochloride Ophthalmic Solution 2% | Sanofi Pasteur Inc.
For intramuscular use only 2.1 Dose and ScheduleThe dose and schedule for Fluzone Quadrivalent are presented in Table 1.
Table 1: Dose and Schedule for Fluzone Quadrivalent Age Dose Schedule "-" Indicates information is not applicable * 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines 6 months through 35 months One or two doses*, 0.25 mL each If 2 doses, administer at least 4 weeks apart 36 months through 8 years One or two doses*, 0.5 mL each If 2 doses, administer at least 4 weeks apart 9 years and older One dose, 0.5 mL - 2.2 AdministrationInspect Fluzone Quadrivalent visually for particulate matter and/or discoloration prior to administration. If any of these defects or conditions exist, the vaccine should not be administered.
Before administering a dose of vaccine, shake the prefilled syringe or vial. Withdraw one dose of vaccine from the single-dose vial using a sterile needle and syringe. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.
The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in persons 12 months through 35 months of age, or the deltoid muscle in persons ≥36 months of age. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Do not administer this product intravenously, intradermally, or subcutaneously.
Fluzone Quadrivalent should not be combined through reconstitution or mixed with any other vaccine.
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