R-Gene (Page 2 of 2)

Test Procedure

The intravenous infusion of R-Gene 10 is a part of the test for measurement of pituitary reserve of human growth hormone and, for successful administration of the test, clinical conditions and procedures should be as follows:

  1. The test should be scheduled in the morning following a normal night’s sleep, and an overnight fast should continue through the test period.
  2. Patients must be placed at bed rest for at least 30 minutes before the infusion begins. Care should be taken to minimize apprehension and distress. This is particularly important in children.
  3. R-Gene 10 (Arginine Hydrochloride Injection, USP) is a hypertonic solution and should only be infused through an indwelling needle or soft catheter placed in an antecubital vein or other suitable vein (see PRECAUTIONS). Blood samples should be taken by venipuncture from the contra-lateral arm.
  4. A desirable schedule for drawing blood samples is at −30, 0, 30, 60, 90, 120 and 150 minutes.
  5. R-Gene 10 should be infused beginning at zero time at a uniform rate which will permit the recommended dose to be administered over 30 minutes.
  6. Blood samples should be promptly centrifuged and the plasma stored at −20°C until assayed by one of the published radioimmunoassay procedures.
  7. Diagnostic test results showing a deficiency of pituitary reserve for HGH should be confirmed by a second test with R-Gene 10, or one may elect to confirm with the insulin hypoglycemia test. A waiting period of one day is advised between tests.

Directions for Use

R-Gene 10 is provided as a ready-to-use solution for patients weighing 60 kg (132 lbs) or more and should not be further diluted. For pediatric patients weighing 59 kg (130 lbs) or less a dose must be placed in a separate container. Follow the preparation instructions below.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

For Pediatric Patients weighing 59 kg (130 lbs) or less

Withdraw a weight-based dose from an intact sealed bottle of R-Gene 10. The entire 300 mL bottle of R-Gene 10 for infusion is not intended for use in patients weighing 59 kg or less. The dose must be placed in a separate container, such as an evacuated sterile glass container designed for intravenous administration, using aseptic technique.

Additionally, R-Gene 10 is stable in polypropylene syringes and plastic containers made of either polyvinyl chloride (PVC) or ethylene vinyl acetate (EVA).

The post-penetration storage period is not more than 4 hours including infusion time at room temperature or 24 hours at refrigerated temperature (2-8°C).

The healthcare professional administering the dose should verify the accuracy of the dose prior to administration.

Use only if the solution is clear. Discard any unused drug product.

For Adults and Pediatric Patients weighing 60kg (132 lbs) or more

Follow these directions using aseptic technique. As R-Gene 10 for intravenous use is provided in glass containers, a standard air-inletting, air-filtering intravenous infusion set with a bacterial air filter is required.

  1. Use only if solution is clear and seal is intact. Carefully examine bottle for evidence of damage, e.g., small cracks, dents in seal, or areas of dried powder on exterior. Do not administer contents if such damage is found.
  2. Remove plastic flip off lid from bottle to expose rubber stopper, taking care that you do not contaminate the target site of the stopper with fingers, hair, clothing, etc. Immediately perform step #3.
  3. With shut-off clamp closed, remove sterility protector from spike of administration set and immediately insert set with a quick thrust into center of stopper with bottle upright on table. (Push straight in — don’t twist — twisting may cause stopper coring.)
  4. Promptly invert bottle to automatically establish fluid level in drip chamber and to check for vacuum by observing rising filtered air bubbles. Discard bottle if there is no vacuum or if the solution is not clear.
  5. Clear tubing of air. Proceed with infusion.
Figures
(click image for full-size original)

HOW SUPPLIED

R-Gene 10 is supplied as a 300 mL fill in 500 mL glass containers.

Preservative Free: Discard any unused portion.

NDC 0009-0436-01

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Solution that has been frozen must not be used.

Logo

LAB-0020-10.0
July 2016

PRINCIPAL DISPLAY PANEL — 300 mL Container Label

NDC 0009-0436-01
Rx only

300 mL Single Adult Dose Container.

R-Gene ® 10
(Arginine Hydrochloride Injection, USP)

For Intravenous Use

30 grams/300 mL
(0.1 grams/mL)

Pfizer

Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 300 mL Container Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 300 mL Container Carton

NDC 0009-0436-01

300 mL Single Adult Dose Container.

R-Gene ® 10
(Arginine Hydrochloride Injection, USP)

For Intravenous Use

30 grams/300 mL
(0.1 grams/mL)

Warning: Do not use this container to administer a dose to
children weighing 59 kg (130 lbs) or less. A weight based dose
must be withdrawn and placed into a separate container for
intravenous administration.
See the Directions of Use subsection.

Rx only

Principal Display Panel -- 300 mL Container Carton
(click image for full-size original)
R-GENE
arginine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0436
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARGININE HYDROCHLORIDE (ARGININE) ARGININE HYDROCHLORIDE 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0009-0436-01 1 CONTAINER in 1 CARTON contains a CONTAINER
1 300 mL in 1 CONTAINER This package is contained within the CARTON (0009-0436-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016931 06/15/1976
Labeler — Pharmacia and Upjohn Company LLC (618054084)
Registrant — Pfizer Inc (113480771)

Revised: 03/2018 Pharmacia and Upjohn Company LLC

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