R-GENE Solution for injection Ref.[108413] Active ingredients: Arginine

Source: FDA, National Drug Code (US)  Revision Year: 2023 

2. Clinical Pharmacology

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.

Expected Plasma Levels of HGH in ng/mL:

Patient Control RangeRange of
Peak Response
to Arginine
Normal 0–6 10–30
Pituitary
deficient
0–4 0–10

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.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term animal studies have not been performed to evaluate the carcinogenic potential, the mutagenic potential or the effect on fertility of intravenously administered R-Gene 10.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.