R-gene 10 for intravenous use

Intravenous infusion of R-Gene 10 often induces a pronounced rise in the plasma level of human growth hormone (HGH) in subjects with intact pituitary function. This rise is usually diminished or absent in patients with impairment of this function.

These ranges are based on the mean values of plasma HGH levels calculated from the data of several clinical investigators and reflect their experiences with various methods of radioimmunoassay. Upon gaining experience with this diagnostic test, each clinician will establish his/her own ranges for control and peak levels of HGH.

L-arginine is a normal metabolite in animals and man and has a low order of toxicity.

There have been two reports of possible overdosage of R-Gene 10 in children. EXTREME CAUTION MUST BE EXERCISED WHEN INFUSING R-GENE 10 INTO PEDIATRIC PATIENTS. OVERDOSAGE OF R-GENE 10 IN PEDIATRIC PATIENTS CAN RESULT IN HYPERCHLOREMIC METABOLIC ACIDOSIS, CEREBRAL EDEMA, OR POSSIBLY DEATH.

R-Gene 10 should always be administered by intravenous injection because of its hypertonicity.

A suitable antihistaminic drug should be available in the event that an allergic reaction occurs.

R-Gene 10 is a diagnostic aid and is not intended for therapeutic use.

Adverse reactions associated with 1670 infusions in premarketing studies were as follows:

Non-specific side effects consisting of nausea, vomiting, headache, flushing, numbness and local venous irritation were reported in approximately 3% of the patients.

One patient had an allergic reaction which was manifested as a confluent macular rash with reddening and swelling of the hands and face. The rash subsided rapidly after the infusion was terminated and 50 mg of diphenhydramine were administered. One patient had an apparent decrease in platelet count from 150,000 to 60,000. One patient with a history of acrocyanosis had an exacerbation of this condition following infusion of R-Gene 10.

An overdosage may cause a transient metabolic acidosis with hyperventilation. The acidosis will be compensated and the base deficit will return to normal following completion of the infusion. If the condition persists, the deficit should be determined and corrected by a calculated dose of an alkalizing agent. See " WARNINGS " for information about overdosage in pediatric patients.

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

NDC 0009-0436-24

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.

Manufactured for

Pharmacia & Upjohn Company

A subsidiary of Pharmacia Corporation

Kalamazoo, Michigan 49001, USA

By

Fresenius Kabi Clayton, L.P.

Clayton, NC 27520 USA

R-Gene is a registered trademark of Pharmacia AB.

Directions for Use of I.V. Container

The important feature of this container is that it is a closed system. That is, no unfiltered air comes in contact with the solution. The spike is thrust through a solid stopper, the air enters through a bacterial air filter, and only filtered air enters the bottle then or during the infusion. The rubber stopper surface beneath the metal seal is sterile.

A special air-inletting, air-filtering set with a bacterial air filter is required. No airway needle is needed.

1. Use only if solution is clear and seal is intact. Carefully examine bottle for evidence of damage, e.g., dents or other evidence of damage to metal cap, small cracks, dents in seal, or areas of dried powder on exterior. Do not administer contents if such damage is found.
2. Remove tamperproof metal seal and metal disc 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.

CAUTION:  While the top of the rubber stopper is sterile, as soon as the seal and disc are removed the stopper is exposed. The longer the time between removal of the seal and disc and the piercing of the stopper, the greater the chance of contamination of the stopper.

NOTE:  When medication is to be added to the bottle:

1. See #1 and #2 above.
2. Add medications before attaching administration set. Vacuum should be observed at this point, by sucking in of additive container content, since vacuum may be lost during this procedure and not observable during administration set insertion.
3. If medications have been placed in bottle through stopper, it is recommended that the face of the stopper be swabbed immediately before piercing with administration set.

CONTINUED USE OF SOLUTIONS AND SETS

Procedure differs with every hospital for the length of time solutions and administration sets may be used continuously. Some recommend change of both every 8 hours, others recommend change of both every 24 hours, and others recommend change of solutions every 8 hours and change of sets every 24 hours. The shorter the period of use the less the possibility of multiplication of organisms inadvertently introduced.

74-3624-16

(Revised August 2003)