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Navstel

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Navstel

INDICATIONS

NAVSTEL® (balanced salt ophthalmic solution) Solution is indicated for use as an intraocular irrigating solution during surgical procedures involving perfusion of the eye.

DOSAGE AND ADMINISTRATION

General Instructions

  • The solution should be used according to the standard technique employed by the operating surgeon.
  • Follow strict aseptic procedures in the reconstitution of NAVSTEL® (balanced salt ophthalmic solution) Solution.
  • Not for injection or intravenous infusion.
  • Do not use if product is discolored or contains a precipitate.
  • Do not use NAVSTEL (balanced salt ophthalmic solution) ® until Part I is fully reconstituted with Part II. Reconstitute just prior to surgery.
  • Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged.

Reconstitution Instructions

  1. Remove the blue flip-off seals from the NAVSTEL® (balanced salt ophthalmic solution) Part I bottle and NAVSTEL® (balanced salt ophthalmic solution) Part II vial. Prepare the stoppers on both parts by using sterile alcohol wipes.
  2. Peel open a NAVSTEL® (balanced salt ophthalmic solution) Vacuum Transfer Device package (supplied) and remove the sterile transfer spike. NOTE: This device is vented permitting air to enter vial during solution transfer, thereby preventing the creation of a vacuum inside the vial. An air-inlet filter is provided to protect the system. Do not remove the air-inlet filter.
  3. Remove protector from the white plastic piercing pin.
  4. Firmly grasp device from behind the flange and insert the white plastic piercing pin into the upright rubber stopper of the NAVSTEL® (balanced salt ophthalmic solution) Part II vial.
  5. Remove guard from filter needle. Firmly grasp vial in the palm of one hand and with thumb and index finger, hold plastic flange against top of vial.
  6. Invert vial and immediately insert filter needle into the outer target of the rubber stopper of the NAVSTEL (balanced salt ophthalmic solution) ® Part I bottle. (See illustration.)
  7. Fluid will automatically transfer from the vial into the large vacuum bottle unless the filter becomes occluded or loss of vacuum occurs. NOTE: An excess amount of NAVSTEL® (balanced salt ophthalmic solution) Part II is provided in each vial. A small amount of residual solution can be expected to remain in the vial.
  8. Immediately remove needle from the NAVSTEL® (balanced salt ophthalmic solution) Part I container and discard it after solution transfer has been completed.
  9. Place a sterile safety cap over the rubber stopper of Part I if the solution is not going to be used immediately. Mix the solution gently until uniform. Peel off the right-hand side of Part I bottle label (fully reconstituted NAVSTEL® (balanced salt ophthalmic solution) ). Record the date and time of reconstitution. NAVSTEL (balanced salt ophthalmic solution) ® is now ready for use.
  10. Reconstituted NAVSTEL® (balanced salt ophthalmic solution) should be used within 6 hours of mixing.

Hanger Device Must Be Assembled Properly Prior to Use - Illustration

Alternative Transfer Method

If preferred, the contents of the NAVSTEL® (balanced salt ophthalmic solution) Part II component may be aspirated with an 18-gauge cannula attached to a 20 mL syringe and then transferred into the Part I bottle.

After Reconstitution

After reconstitution, use a single patient administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow the directions for the particular administration set to be used. Insert the spike aseptically into the bottle through the center target area of the rubber stopper. Allow the fluid to flow to remove air from the tubing before intraocular irrigation begins. If a second bottle is necessary to complete the surgical procedure, insure that the vacuum is vented from the second bottle BEFORE attachment to the administration set.

HOW SUPPIED

Dosage Forms And Strengths

  • 250 mL: 250 mL bottle filled with 240 mL Part I and 10 mL vial filled with 10 mL Part II of sterile intraocular irrigating solution
  • 500 mL: 500 mL bottle filled with 480 mL Part I and 20 mL vial filled with 20 mL Part II of sterile intraocular irrigating solution

NAVSTEL® (balanced salt ophthalmic solution) Solution is supplied in two sizes, 250 mL and 500 mL. Each size consists of two packages for reconstitution prior to use: 250 mL size consists of a 250 mL glass bottle containing 240 mL (Part I) and a 10 mL glass vial (Part II); both using grey butyl stoppers and aluminum seals with polypropylene flip-off caps; 500 mL size consists of a 500 mL glass bottle containing 480 mL (Part I) and a 20 mL glass vial (Part II); both using grey butyl stoppers and aluminum seals with polypropylene flip-off caps. Each of the two packages also contains a Vacuum Transfer Device.

Product must be reconstituted prior to use [see DOSAGE AND ADMINISTRATION].

  • 250 mL fill.....................NDC 0065-0810-24
  • 500 mL fill.....................NDC 0065-0810-48

Storage

Store between 2° and 25°C (36° and 77°F). DO NOT FREEZE.

Handling

Solution should be used when between 15° and 25°C (59° and 77°F). Discard prepared solution after 6 hours.

ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA. FDA Rev date: 7/24/2008

Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.

A A A

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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