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R-GENE® 10 (arginine HCl)

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R-GENE® 10 Quick Finder

INDICATIONS AND USAGE

R-Gene 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness...

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DOSAGE AND ADMINISTRATION

Adult Dosage

The recommended adult dose is 30 g arginine hydrochloride (300 mL of R-Gene 10) administered by intravenous infusion over 30...

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CONTRAINDICATIONS

The administration of R-Gene 10 is contraindicated in persons having known hypersensitivity to any ingredient in this product.

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WARNINGS

There have been reports of overdosage of R-Gene 10 in pediatric patients leading to death. EXTREME CAUTION MUST BE EXERCISED WHEN INFUSING R-GENE 10 INTO PEDIATRIC PATIENTS. OVERDOSAGE OF R-GENE 10 IN PEDIATRIC...

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ADVERSE REACTIONS

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...

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OVERDOSAGE

An overdosage may cause a transient metabolic acidosis with hyperventilation, which could lead to death (see "WARNINGS"). In most cases the acidosis will self-compensate and the base deficit...

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DESCRIPTION

Each 100 mL of R-Gene® 10 (Arginine Hydrochloride Injection, USP) for intravenous use contains 10 g of L-Arginine Hydrochloride, USP in Water for Injection, USP (equivalent to a 10%...

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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...

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HOW SUPPLIED

R-Gene 10 is supplied as a 30 g/300 mL (0.1 g/mL) fill in 500 mL glass containers.

Preservative Free: Discard any unused portion.

NDC 0009-0436-01

Exposure of...

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For Intravenous Use

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