Intended only for use by patients of the Mount Rainier Clinic, Inc.,
 Yelm, Washington, (360)-458-1061

Omnitrope Instructions - Revised 06-08-2007

Step-by-Step Instructions for Administration
of Omnitrope™
HUMAN GROWTH HORMONE (HGH)

Omnitrope™ (somatropin rDNA for injection) is manufactured by Sandoz Pharmaceutical Company and is packaged in vials containing 17.4 units (5.8 milligrams per vial) of bioidentical HGH. Omnitrope™ is licensed by the FDA (NDC 43858-701-01) to meet the highest standards of purity, safety and effectiveness.

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The law requires that HGH must be prescribed by a licensed health care provider. HGH by injection is used to correct deficiencies that occur with age, and to replace normal, youthful levels of this vital hormone. Before replacement therapy is begun, a baseline blood level of IGF-1 (formerly called somatomedin-C) should be measured by a federally licensed clinical laboratory to determine potential for benefit. Because blood levels of HGH fluctuate widely during the day, IGF-1 is measured instead. IGF-1 is the most reliable indicator of total daily HGH release by the pituitary gland. Benefits from HGH replacement occur slowly over several months, and full benefit may take six months to a year or longer. The lower the initial IGF-1, the sooner improvements are experienced.

HGH replacement is more effective when DHEA and other hormones that have diminished with age are also replaced. When deficient, estrogen-progesterone replacement (for women) and testosterone replacement (for men), using bioidentical hormones, can add significantly to benefits from HGH. Many essential hormones decline with age. The goal of hormone replacement is to restore approximately those levels that were necessary for good health during early adulthood. Levels that were safe and beneficial at age 30 will remain safe and effective when restored to that same level later in life. Adverse effects can occur when excessive doses are used or from unnatural and synthetic hormones. We recommend only safe, physiologic replacement doses using bioidentical hormones.

After pretreatment evaluation and baseline laboratory testing, if HGH replacement is indicated we can provide you with a supply of HGH. Prior to use, you must carefully add diluent to the vial of freeze dried HGH powder. A separate vial of sterile bacteriostatic water is provided for this purpose. Use the diluent to dissolve the HGH powder into solution before injection, following the detailed directions below. If desired, we can do this for you in the clinic and provide you with pre-filled syringes ready for injection. Once diluent is added, the HGH in solution should be refrigerated and used within 5 weeks for full potency.

It has been stated elsewhere that HGH should be used within 3 weeks after adding diluent. Expert chemists who manufacture HGH assure us that this 3-week figure includes a large safety factor and if used within 6 weeks of mixing, and if refrigerated during that time, there will not be a significant loss of potency.

Some brands of HGH call for refrigeration of the dry powder, even before adding diluent. Undiluted HGH powder has been shown to retain full potency for 18 months when stored at normal room temperature.

Undiluted, freeze-dried HGH powder in sterile vials may safely be stored at room temperature for up to a year or longer (until the expiration date on each vial). It is recommended to refrigerate vials of undiluted, freeze-dried HGH powder if storage temperatures would otherwise exceed a comfortable room temperature pf 80 degrees Fahrenheit for a lengthy period of time. Once diluent is added, however, the resulting liquid HGH should be kept refrigerated and completely used within approximately 5 weeks—or potency will slowly decline.

Diluent is a solution of bacteriostatic water, formulated to maintain sterility. A separate vial of diluent is provided at no additional cost for each 17.4 unit vial of Omnitrope™ HGH.

The Omnitrope™ vial initially contains a dry, white, sterile, purified, freeze dried, powdered form of pure HGH. The diluent is a clear, colorless, aqueous solution. The diluent vial and Omnitrope™ HGH vial are both clearly identified on their labels. Diluent is labeled “Bacteriostatic water for injection.” You will also be provided with 1 mL syringes to use for injection, and a 3-mL syringe for adding diluent. Syringes will have needles attached. Please notify us if you need more diluent or syringes.

Clinic staff will demonstrate the following procedures for you until you feel confident by yourself at home. Alternatively, you may have a nurse, friend, or relative help you to become proficient at doing this. Please telephone the clinic if you have questions or need help. We can premix and load syringes for you at the clinic for an additional charge. Only one vial at a time is mixed and shipped in pre-loaded syringes because of the need for refrigeration and use within 5 weeks. Preloaded syringes are shipped on ice by overnight UPS (United Parcel Service, Red Label). Be sure to make arrangements for refrigeration of preloaded syringes.

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Mixing Instructions

The abbreviations “cc” for cubic centimeter and “mL” for milliliter are sometimes used interchangeably and they basically mean the same thing. Some syringes are labeled “cc” and others are labeled “mL”. Diluent syringes hold a total of 3 mL and the syringes used for injection hold a total of 1 mL.

Before the vials are first used, they will have either a plastic cap or a metal tab covering the rubber stopper. It’s necessary to remove that cap or tab. This is done by simply pushing up on the cap and breaking the seal. The tip of a sharp knife can be used to lift up on the metal tab. Under those covers you will find a rubber stopper with a small circle in the center, through which the needle is inserted. It’s important to keep the rubber stopper clean and sterile. Before each use, carefully wipe the stopper with an alcohol swab on both the diluent and HGH vials. Then do not allow anything to touch those sterile areas except the sterile needle.

Remove the 3-mL diluent syringe from its wrapper. Before removing the plastic guard from the needle, twist the guard firmly in a clockwise direction to insure that the needle is screwed tightly onto the syringe. Carefully remove the plastic guard from the sterile needle. Do not touch the needle and do not allow the needle to come in contact with anything that might contaminate it. Draw up 1.8 ml of air into the syringe. Insert the needle into the diluent vial with the vial in an upright position. Slowly push in the plunger to add the air to the diluent vial.

Keep the needle in the diluent vial and turn the vial upside down. With the needle inserted into the diluent, draw back on the plunger until exactly 1.8 ml of diluent is in the syringe. You may need to gently tap the syringe a few times to cause any air bubbles rise to the top. Move the plunger in and out slightly until all air is out of the syringe. Adjust the plunger so that exactly 1.8 ml of diluent remains in the syringe while carefully removing the needle from the diluent vial. Do not allow the needle to touch anything that might contaminate it. Graduations in mL and fractions of mL are clearly marked on the barrel of each syringe. If the diluent vial is close to empty, take care to keep the tip of the needle below the level of the liquid, only slightly inside the rubber stopper, so that diluent and not air is drawn into the syringe. We will send more diluent on request if needed.

Slowly inject diluent into the HGH vial as follows: With the vial upright, insert the needle through the center of the HGH vial and angle the tip of the needle toward the vial wall. Tilt the vial slightly to allow diluent to run down the inside of the vial wall. Slowly push the plunger, releasing the diluent against the vial wall, allowing it to running down onto the HGH powder. Take care that exactly 1.8 mL of diluent is added. Do not inject forcefully as the HGH will foam if agitated. Foam can stick to the inside of the vial, causing slight loss of HGH. For the same reason, do not shake the HGH vial during or after mixing.

The HGH vials initially contain air. After adding diluent it is necessary to slowly draw back on the syringe to approximately the 1.8 mL level to equalize the increase in air pressure caused by adding diluent. Keep the needle tip is in the air space above the HGH solution so that only air and not HGH is removed. Remove the syringe from the vial.

Slowly and gently roll or rotate the HGH solution until it is all dissolved. The HGH is now diluted in 1.8 mL of bacteriostatic sterile water. (This allows a tiny bit extra to compensate for solution that inevitably adheres to the inside of the vial and cannot be totally withdrawn.) The resulting solution contains 17.4 units of HGH at a concentration of 1 unit per 0.1 mL (1/10th of a mL) of solution.

For injection, one unit of HGH will now be contained in each 0.1 mL (1/10th mL = 1 unit HGH)

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Storage, Handling, and Traveling

After the HGH is fully dissolved, keep it refrigerated. Do not allow it to freeze. It is allowable for the mixed vial to be out of the refrigerator after the diluent has been added for only up to 12 hours when traveling, but insure that it does not get any warmer than 80 degrees Fahrenheit.

Do not allow the HGH solution to get hot. DO NOT SHAKE the vial, as the solution will foam, causing some to stick to the glass walls of the vial, making it impossible to extract the entire desired amount. Some patients find it more convenient to transfer all of their HGH from the multidose vial into individual syringes immediately after mixing with diluent. Each syringe will contain one dose (0.1 mL for one unit, 0.15 mL for 1.5 units, or 0.2 mL for 2 units, depending on daily dose). Store loaded syringes in the refrigerator.

The HGH solution for injection is stable for up to 24 hours at room temperature (not over 80 degrees Fahrenheit) and for up to five weeks if constantly refrigerated. Potency is slowly lost after that if not refrigerated. The higher the temperature, the shorter time the full potency is retained. If used within 5 weeks and stored properly, loss of potency will be insignificant. A small, insulated CoolPack™ can be used to store your vial of HGH during extended travel, and may be ordered through this office. Be careful that the CoolPack™ is not excessively cold or the HGH solution might freeze.

If you travel and will not be at home to receive your HGH shipment, please advise us in advance of the proper shipping instructions and address. If you plan to travel and wish to order more than your usual supply in advance, please notify us. In addition, if you are leaving the country, we can provide a letter certifying that a licensed health care provider has prescribed the injectable medication and syringes. This can avoid embarrassment if customs officials search your luggage. Because there are many travelers with diabetes who carry their insulin and syringes of the same type, this should not cause a problem.

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Shipping Schedule

We normally ship your supply of HGH via overnight courier (UPS Red Label) to arrive on Tuesdays, Wednesdays, Thursdays or Fridays. You will be notified by telephone of the shipment date so that you can look for delivery. You will receive your vial(s) of HGH, diluent, disposable syringes, used syringe “sharps” disposal container and alcohol swabs in the shipment. There is no need to refrigerate prior to adding diluent unless room temperature is normally higher than 80 degrees F for an extended period of time. To be on the safe side, you might want to keep your vials of undiluted, powdered HGH in the refrigerator. Do not allow even unmixed HGH to remain in an automobile that is parked in the hot sun.

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Cost

The cost for each 17.4-unit vial of HGH is now $295.00 ($16.95 per unit), plus actual shipping cost. Overnight shipping costs will vary from approximately $25 to $60 depending on destination. You will be charged to your credit card, or paid in advance, as instructed by you at the time of each shipment. Syringes with needles attached, diluent, a sharps container and alcohol swabs are included at no additional cost. If you need more, please call.

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Dosage

The most common dose is one unit of HGH taken daily in the evening, close to bedtime, although the time of day is probably not that important as long as daily doses are taken at approximately the same time of day. See detailed directions on filling the syringe below. The minimum cost effective dose for benefit is one unit daily for at least 4 consecutive days per week. Based on many years of experience, a 4-day schedule has been found to be the minimum dosing to achieve cost effective benefit.

Some patients take 1.5 or 2 units daily for added benefit at higher cost. More than 2 units daily are not recommended and may cause side effects. Syringes used to add diluent can hold a total of 3 mL and the syringes used for injection hold a total of 1 mL.

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Filling the Syringe & Getting Every Last Drop

In order to get the correct dose with each injection and to get the desired number of doses from each vial, take care with the following steps:

a) Remove the protective needle cover from the needle on the 1 mL disposable syringe, being careful not to touch the needle to preserve sterility. Place the Omnitrope™ vial on a tabletop, stopper-side up. Pull back the plunger to draw an amount of air into the syringe equal to your dose. Insert the needle straight down into the vial, holding the vial and syringe perfectly in line. Be sure that the needle enters straight through the very center of the rubber stopper. There is a small circle on the top of the stopper, which marks the center.

b) After the needle is inserted, slowly press the plunger all the way in, adding an amount of air to the vial equal to the dose you’ll withdraw. Keeping the needle inserted into the vial, hold the vial and syringe in your hand and gently turn both vial and syringe together to a vertical position, upside down, so that the syringe is on the bottom and the HGH solution runs into the depression and notch just inside the stopper.

c) The tip of the needle should be within the HGH solution and not in air.
If this is close to the last dose in the vial, rotate the vial, continuing to hold it straight upside down, until you can see through the notch in the rubber stopper, inside the vial. You should be able to see into a depression inside the stopper, where the needle first enters the vial, and where the last of the HGH is pooled. The tip of the needle will be seen protruding into the pool of HGH solution.

d) The tip of the needle must be kept within the solution to get the last drop. For the last few doses in the vial it is necessary to slowly pull the needle back until just the very tip is visible coming just through the inside of the stopper.

e) Taking care to hold the tip of the needle in that position (barely penetrating the inside surface of the stopper), draw back on the plunger of the syringe until the desired amount of HGH solution has been drawn up. (Initially, when more doses remain in the vile, the needle can penetrate further into the vial without a problem.)

f) To measure your daily dose, first draw up slightly more than the desired dose of HGH into the 1 mL syringe. A dose of 1 unit will fill the syringe to the point where it is marked "0.1" (10% of a full syringe). A dose of 1½ unit will be “0.15” mL on the graduated scale (15% full). Two units comes to “0.2” mL (20% full). Slowly pull back on the plunger until the slightly more than desired dose is in the syringe. Tap on the syringe to cause any air bubbles to rise to the top and then gently inject any air back into the vial. Move the plunger in either direction until exactly the desired dose is contained in the syringe. It will not hurt is a tiny amount of air or foam remains in the syringe at the time of injection.

g) Unavoidable small errors in dilution and when loading syringes may cause the amount of HGH seem to vary slightly from vial to vial. Foaming can also cause some HGH to stick to the inner walls of the vial or otherwise not be available for injection. A small amount of solution also adheres to the inside of an empty vial and this varies somewhat from vial to vial. By adding 1.8 ml of diluent to 17.4 units of HGH you should be able to get at least 17 usable units and perhaps a bit more. Expect the amount of HGH available in the last syringe to vary slightly from vial to vial.

h) NOTE WELL: The rubber stopper has a crosswise notch or open slit on the inside of the bottle. It is necessary to turn the inverted vial until you can sight across that notch and draw the tip of the needle back to get all of the HGH into the last syringe. If care is not taken, you might miss the last few drops.

i) Cleanse the skin at the injection site using an alcohol swab. Gently pinch up or lift a layer of skin and subcutaneous fat between your fingers. Insert the tiny needle into this skin fold, and press the plunger in all the way to inject the dose. The abdomen, above the navel, is a convenient location—avoiding the belt line, which can be irritated by pressure. The thigh is another convenient site. The doctor or nurse will demonstrate the proper procedure in the clinic when HGH is first prescribed. After the needle is withdrawn, hold pressure on the puncture site for several minutes to prevent bruising and discoloration.

If the HGH solution becomes cloudy in the refrigerator after mixed, let it warm up a bit for a few minutes and gently roll the vial between your hands before use. This should clear the solution. A slightly cloudy or mildly opaque appearance is acceptable if no discrete particles are visible. Your daily doses can made up in advance in preloaded syringes which can then be stored in a refrigerator. Do not allow them to freeze.

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Alternate Dosing Option

Some patients choose to administer half the daily dose of HGH at bedtime and half on arising in the morning. There have been anecdotal reports of slightly increased benefit with the same total daily dose, although added benefit is doubtful and the number of injections is doubled.

If you decide to split your daily doses, taking half at night and half in the morning, you will need twice as many syringes. If you desire to use this twice-daily dosing option, please let us know and we will ship the additional number of syringes needed with no charge.

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Questions & Follow-Up
If any questions occur or if you believe you are having any problems with treatment, please call our office (360) 458-1061.

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Syringe Disposal

Used syringes are considered “biohazard waste”, and it is against the law to toss them out with your other garbage and waste. For this reason we include a biohazard waste “sharps” container in which to place your used syringes. Or you may cause them to be incinerated at high temperature or otherwise destroyed to insure that no environmental contamination from blood could occur. If you cannot safely dispose of used syringes yourself, you may return them to our clinic. We have a licensed biohazard disposal service that makes regular pickups.

Reported Benefits of HGH

Benefits of HGH replacement by injection reported in the medical literature are described below. Benefits are gradually achieved over six to twelve months after restoring growth hormone levels in older patients to levels that are normal for a healthy young adult. Benefits may continue to increase for up to 18 months or more after beginning therapy. If therapy is stopped, body tissues slowly return to their original, to the state they would be in if HGH were never used. Some benefits experienced during HGH replacement may be retained. There are no withdrawal symptoms and no rebound—merely a slow return close to an untreated state over several months.

It’s scientifically well documented that secretion of growth hormone by the pituitary gland decreases progressively with age. Starting after adolescence, secretion of growth hormone steadily declines until the amount present in older people is only a small fraction of younger levels, often less than 10%. Adverse effects of aging observed to occur with this decline of HGH secretion include the following:

* 5% increase in fat with each 10 years of life
* Decreases in muscle strength, skin thickness, bone density
* Diminished physical endurance, mental ability, and immune defenses
* Skin wrinkles
* Osteoporosis
* Alzheimer’s dementia
* Senility
* Obesity
* Fatigue
* Muscle and organ atrophy
* And other age-related impairments

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Benefits of HGH Replacement as Reported in Published Scientific Studies Include
* 15% average decrease in fat.
* 8% average increase in muscle and lean body structures.
* Improved skin texture and a more youthful appearance.
* Fewer skin wrinkles.
* Increased bone density, reversal of osteoporosis.
* Faster healing of any type of injury, fracture, or wound.
* Enhanced immunity and resistance to infection.
* Enhanced brain function, retention of intellect with aging.
* Prevention of Alzheimer’s and Parkinson’s syndromes.
* Improved sex drive.
* Improvement in overall physical and mental well-being.
* Improvement in sleep disorders, better quality of sleep.
* Improved exercise tolerance.
* Improved metabolism and mineral balance.
* Improved mood, with less depression and fatigue.
* Improved heart and kidney function.