Saizen

Saizen is used for:
Treating certain children or adults when the body does not produce enough growth hormone. It may also be used for other conditions as determined by your doctor.
Saizen is a growth hormone that produces effects that are identical to the body's naturally occurring growth hormone. It affects the growth of bones, muscles, internal organs, and other tissues of the body.
Use Saizen as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Saizen is sometimes used at home as an injection. Before you use Saizen , a health care provider will provide detailed instructions for its appropriate use. Ask any questions that you may have about Saizen or giving injections.
If you are using Saizen at home, carefully follow the injection procedures taught to you by your health care provider. If the medicine contains particles, is discolored, or if the vial/container is cracked or damaged in any way, do not use it.
Always change the location where you inject Saizen .
Do not shake Saizen . Swirl the vial gently to mix it.
If you miss a dose of Saizen , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Saizen
Saizen may cause dizziness. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity.
Never reuse needles and syringes. Follow your health care provider's instructions for proper disposal of needles and syringes. Ask your health care provider or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full.
Saizen may contain benzyl alcohol. Tell your doctor if you have ever had sensitivity or an allergic reaction to benzyl alcohol.
Diabetes patients - Saizen may affect your blood sugar levels. Check your blood sugar levels closely and ask your doctor before adjusting your diabetes medicine or changing your diet.
Lab tests, including blood electrolytes, thyroid function, and eye exams, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
Use Saizen with caution in the ELDERLY because they may be more sensitive to its effects.
Rare, sometimes fatal, lung and breathing problems may be caused by Saizen in CHILDREN with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or children with existing serious lung or breathing problems. Children should be checked for certain breathing problems before and during treatment. If your child develops a limp or complains of hip or knee pain during treatment with Saizen , contact your doctor immediately. Tell your doctor immediately if your child becomes very sick or is hospitalized while using Saizen . Saizen may need to be stopped.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss the benefits and risks of using Saizen during pregnancy with your doctor. It is unknown if Saizen is excreted in breast milk. If you plan to breast-feed while you are using Saizen , talk with your doctor about the risks to your baby.
Store unmixed medicine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat and light. After mixing, store Saizen according to the product label. Contact your pharmacist if you have questions about the proper storage of Saizen . Keep Saizen , as well as needles and syringes, out of the reach of children and away from pets
If you have any questions about Saizen , please talk with your doctor, pharmacist, or other health care provider.
Saizen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

R-Gene 10

Each 100 mL of R-Gene® 10 (10% Arginine Hydrochloride Injection, USP) for intravenous use contains 10 g of L-Arginine Hydrochloride, USP in Water for Injection, USP. L-arginine is a naturally occurring amino acid.
R-Gene 10 is hypertonic (950 mOsmol/liter) and contains 47.5 mEq of chloride ion per 100 mL of solution. The pH is adjusted to 5.6 (5.0–6.5) with arginine base or hydrochloric acid.
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
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. It can be used as a diagnostic aid in such conditions as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism and problems of growth and stature.
If the insulin hypoglycemia test has indicated a deficiency of pituitary reserve for HGH, a test with R-Gene 10 is advisable to confirm the negative response. This can be done after a waiting period of one day. As patients may not respond to R-Gene 10 (10% Arginine Hydrochloride Injection, USP) during the first test, the unresponsive patient should be tested again to confirm the negative result. A second test can be performed after a waiting period of one day. Some patients who respond to R-Gene 10 do not respond to insulin and vice versa. The rate of false positive responses for R-Gene 10 is approximately 32%, and the rate of false negatives is approximately 27%.
The administration of R-Gene 10 is contraindicated in persons having highly allergic tendencies.
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.
R-Gene 10 is a hypertonic (950 mOsmol/liter) and acidic (average pH of 5.6) solution that can irritate tissues. Care should be used to insure administration of R-Gene 10 through a patent catheter within a patent vein. Excessive rates of infusion may result in local irritation and in flushing, nausea, or vomiting. Inadequate dosing or prolongation of the infusion period may diminish the stimulus to the pituitary and nullify the test.
The arginine in R-Gene 10 can be metabolized resulting in nitrogen-containing products for excretion. The effect of an acute amino acid or nitrogen burden upon patients with impairment of renal function should be considered when R-Gene 10 is to be administered.
The chloride content of R-Gene 10 is 47.5 mEq per 100 mL of solution, and the effect of infusing this amount of chloride into patients with electrolyte imbalance should be evaluated before the test is undertaken.
It should be noted that the basal and post stimulation levels of growth hormone are elevated in patients who are pregnant or are taking oral contraceptives.
Carcinogenesis, mutagenesis, and 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.
Pregnancy Category B
Reproduction studies have been performed in rabbits and mice at doses 12 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to R-Gene 10 (10% Arginine Hydrochloride Injection, USP). There have been no adequate or well controlled studies for the use of R-Gene 10 in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy.
Nursing Mothers
It is not known whether intravenous administration of R-Gene 10 could result in significant quantities of arginine in breast milk. Systemically administered amino acids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when R-Gene 10 is to be administered to nursing women.
Geriatric Use
Clinical studies of arginine did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.