Consult with a
licensed doctor or pharmacist (pharm-D) before taking any
prescription or OTC (over the counter) drugs (including any herbal
medicines or supplements) or following any treatment or regimen.
Only a licensed doctor or pharmacist can provide you with advice on
what is safe and effective.
deterioration of the body that comes with growing old is not
We now realize that some aspects of it can be prevented
-Dr. Daniel Rudman (New England Journal of
Many researchers have concluded that one of the
primary causes of aging is the decrease of hgh human growth hormone
production. According to Dr. Ronald Klatz, M.D.,
President of the American Academy of Anti-Aging Medicine, "Aging
appears to be due in large part to the drastic decline of growth
hormone in the body after adulthood."
According to hgh human growth hormone research, at age
21, the normal level of circulating hgh is about 10 milligrams per
deciliter of blood, but at age 61, it's decreased 80% to only 2
milligrams. They say it's growth hormone that grows the cells,
bones, muscles, and organs, and it is the level of growth
hormone after age 30 that slowly robs us of our
After age 30, the secretion rate of hgh drops14% per
decade. By 80, most people barely produce enough hgh to
build a fingernail, explaining why injuries experienced by seniors
take so long to heal.
hgh human growth hormone research Clinical
The New England Journal of Medicine published the clinical
findings of Daniel Rudman, MD, regarding his hgh human growth
hormone research on the anti-aging effects of hgh. His
findings were astonishing.
Dr. Rudman studied patients age 61 to 81 at the Medical
College of Wisconsin-Milwaukee. After six months, Dr. Rudman
observed a reversal of the aging process from 10 to 20 years in the
patients who received hgh injections. But in the control group
(those who didn't receive hgh), the normal aging process
Other hgh human growth hormone research clinical studies
performed over the past 30 years have demonstrated that hgh can
allow users to lose fat, build muscle mass, improve sexual
performance, remove wrinkles, eliminate cellulite, and increase
immune function when taken through intra-muscular injections.
Hgh is what you might consider a "master hormone" which is secreted
by the pituitary gland and is responsible for directly and
indirectly balancing the body's critical
Chein of the Life Extension Institute in Palm Springs, CA, said he
studied 202 patients that he treated with hgh. Here are the results
Patients reported Improvement in
the following areas:
- Attitude Toward Life 78%
- Back Flexibility 83%
- Body Fat Loss 72%
- Duration of Penile Erection 62%
- Emotional Stability 67%
- Exercise Tolerance 81%
- Frequency of Nighttime Urination 57%
- Hot Flashes 58%
- Healing Capacity 71%
- Healing of Other Injuries 61%
- Sexual Function, Sexual Potency/Frequency 75%
- Strength, Exercise & Body Fat, Muscle Strength
- Muscle Size 81%
- Menstrual Cycle Regulation 39%
- Skin & Hair Care, Skin Texture 71%
- Skin Thickness 68%
- Skin Elasticity 71%
- Wrinkle Disappearance 61%
- New Hair Growth 38%
- Energy, Emotions & Memory, Energy Level 84%
- Memory 62%
- Resistance to Common Illness 73%
Chein guaranteed a loss of 10 to 12 percent of body fat every
six months if they are overweight, and a gain of 8 to 10 percent in
muscle mass every six months, continuing every six months until body
composition has reverted to that of a twenty year old (treating them
with hgh along with other hormones). He says, "If I can't get the
blood level of your hormones to look like that of a twenty year old,
you can get all your money refunded."
Your physician's guidance and blood
monitoring is essential on a program of hGH.
Physician's administering hGH for preventative / anti-aging
purposes utilize in the region of 0.01mg
of hGH per Kg (2.2 lbs.) of body weight .
Example: A 200 lb man would be @ 1.5 to 2 iu of Humatrope per
day. A 115 lb woman would be at 1/2 to 1 iu per day of
Humatrope. This is injected subcutaneously (just under the
skin) divided into usually 3 to 6 injections per week.
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G.H., Can it help with Muscle
Building and Athletic Performance?
According to the president of the American Academy of Anti-Aging
Medicine, Dr. Ronald Klatz, "The body-building action of GH has now
been shown in many different groups, including athletes, healthy
young untrained men, GH-deficient adults, and elderly men."
When the GH therapy is stopped, the benefits slowly
Dr. Edmund Chein even makes it a point to not talk
about "fat" with his patients because "we talk about percentage
of fat and percentage of lean muscle. You are
reversing, losing fat and gaining lean muscle. Your net weight
may stay the same or even go
In a recent BBC article, they
identify HGH as being potentially the next "Sports Menace".
Why? In their
article titled "Human growth hormone explained,"
the BBC points out the potential muscle building and performance
enhancing capabilities of GH. Their concern lies in the
fact ".. it is almost impossible to set a blood level of GH
that would be considered unnaturally high and indicative of doping,
because levels of naturally-occurring GH can vary by more than
100-fold in response to factors such as nutritional state, sleep and
Regardless of perspective, the one
thing all three of these sources agree on is clear. They all agree upon the benefits of GH
for muscle building as well as athletic
medicine enters the 21st century, there is growing recognition
from physicians, clinicians and biomedical researchers that human
lifespan can be prolonged and that premature deterioration from
things such as cardiovascular disease, cancer, diabetes, stroke and neurodegenerative disorders
such as Alzheimer's and Parkinson's may be delayed
and prevented. At the center of much of this research is H.G.H.
or Human Growth Hormone.
G.H., Is it
the Master Hormone of Youth?
is a direct quote from the American Academy of
Anti-Aging Medicine web-site.
people think of GH as the miraculous treatment for children doomed
to dwarfism (over the past 30 years it has saved tens of thousands
from this fate). HGH therapy has been so effective for our young
that a remake of The Wizard of Oz is nearly impossible today, due to
this medical achievement.
The next great benefit of HGH therapy
appears to be in the aging
People with age related deficiency
of GH become fat, flabby, frail, and lethargic, lose interest in sex, have trouble
sleeping, concentrating, remembering things, tire easily, and in general, lose their zest for
With HGH, all these so-called signs of aging
the natural decline of
Growth Hormone production!
When Dr. Daniel Rudman, a pioneer researcher and his colleagues
at the Medical College of Wisconsin published their article in the
prestigious New England Journal of Medicine they broke new ground in
the field of anti-aging medicine.
It was the first clinical
trial of elderly men on GH, comparing the
effects of six months' of GH injections on twelve men, ages
sixty-one to eighty-one, with an age-matched control group. Their
results made headlines all over the world. Those taking the
hormone injections gained an average of 8.8
percent in lean body mass and lost 14 percent in
fat, without diets or exercise. Their skin became
thicker and firmer and the lumbar bones of the spine
Published in the New England Journal of
Medicine, the researchers wrote: "The effects of six months of human
growth hormone on lean body mass and adipose-tissue mass were
equivalent in magnitude to the changes incurred during 10 to 20
years of aging."
It's important to realize, HGH declines with age in every animal species that has
been evaluated to date.
In humans, the amount of GH after ages twenty-one to thirty-one
falls about 14 percent per decade, so that the total
twenty-four-hour GH production rate is reduced in half by age sixty.
In numerical values, on a daily basis we produce about 500 mcg
(micrograms) at age twenty, 200 mcg at age forty, and 25 mcg at age
eighty. The fall in IGF-1 with an increase in age mirrors that of
Did you know? Dr. Rudman considered plasma IGF-1 levels under 350
evidence of a deficiency.
HERE: Published HGH Studies from the New England Journal of
your Growth Hormone levels?
Order an accurate Blood or
Between the ages
of twenty and forty years, fewer than 5 percent of healthy men have
IGF-1 levels lower than 350.
According to Dr. Ronald Klatz and
Dr. Robert Goldman of the American Academy of Anti-Aging Medicine,
".. after age sixty, 30 percent of apparently healthy men have this
low amount. And after age sixty-five, about half the population is
partially or wholly deficient in GH."
Each bottle contains 15 IU (5mg)
of biosynthetic human growth hormone (from recombinant
DNI), excipients include Glycine, mannitol, bibasic
sodium phosphate. Each bottle of diluent contains
m-cresol, glycerin and water for
Pharmaceutical Classification of
Sterile freeze-dried powder of systemic
Directions for usage of
Long-term treatment for stunted
growth, due to the reduction or lack of somatotrophic
endogenous hormone secretion in-patients who have not
yet finished puberty. Treatment of short stature in
girls suffering from Turner’s syndrome confirmed by
chromosomal analysis (the effect on final height has not
yet been established).
Hypersensitivity in certain
patients to the product or any of its ingredients.
Patients with complete knitting of the epiphyses.
Diabetes mellitus. Humatrope should not be used if there
is any sign of active neoplasms. Endocrane lesions must
be inactive and anti-tumoral treatment finished before
beginning hormonal treatment. The use of Humatrope must
be interrupted in the event of renewed tumoral growth.
Humatrope must not be reconstituted with the
accompanying diluent if the patient is sensitive to
m-cresol or glycerin.
Precautionary measures in the usage of
Humatrope treatment should only be
carried out under a doctor’s authorization, by
prescription, by university medical centers or hospitals
specializing in the treatment of patients with growth
hormone deficiency. Diagnoses must be confirmed before
beginning Humatrope injections. This requires a clinical
examination of the patient with detailed case histories,
particularly with regard to auxilogical evaluations and
the carrying out of laboratory tests, including stimulus
test, to verify hypophysial hypothalamus functioning.
Humatrope therapy should be carried out by a specialist
in the diagnosis and treatment of patients related to
stunted growth. Patients who, following diagnosis,
undergo treatment with the somatotrophic hormone will
have to be inscribed in a regional register and
monitored by means of clinical auxilogical and
laboratory evaluations every six months to check the
functioning of the thyroid, glucide metabolism etc. The
lack of available information may mean the exposure of
the patient to a risk, which may exceed the therapeutic
benefit obtained. Human hormone growth treatment should
be complemented by an adequate supply of calories and
amino acids. Once reconstituted with the accompanying
diluent, Humatrope can be taken in subcutaneous or
Carcinogenesis, Mutagenesis and Fertility
Alterations using Humatrope:
Long term studies
with Humatrope on animals have not been carried out,
which would enable the evaluation of any carcinogenic or
fertility altering effect which this pharmaceutical
product may possibly have. No mutagenic effect due to
Humatrope has been seen in tests up to the
during pregnancy and nursing:
Humatrope and its effects on animal reproduction have
not been carried out. It has not been seen that
Humatrope can harm the fetus during pregnancy, nor that
it can affect reproduction. Nevertheless, Humatrope
should only be taken during pregnancy if absolutely
necessary. Studies of the effects of Humatrope on
nursing mothers have not been carried out and hence it
is not known whether this product is excreted into
mother’s milk. However, since many pharmaceutical
products are indeed passed into mother’s milk, nursing
mothers are advised to take Humatrope with extreme
Since taking Humatrope may cause
resistance to insulin, patients should undergo periodic
check ups in order to detect any intolerance to glucose.
Children suffering from diabetes mellitus should be
carefully supervised during Humatrope treatment, as it
may be necessary to increase their insulin dosage.
Excessive glucocortoid treatments may inhibit the effect
of growth stimulation provided by the human
somatotrophic hormone. In the case of patients who also
suffer from ACTH (adrenocrticotrophic hormone)
deficiency, the substitutive dosage of glucocorticoids
must be accurately regulated in order to prevent any
inhibitory effect on growth.
Please be advised when using
Attentive and constant supervision
by the specialist is advised during growth hormone
treatment of patients with neoplasms in remission. Those
with a shortage of the growth hormone accompanying an
endocrane lesion must be checked particularly frequently
so as to prevent spreading or a relapse. Patients with
growth hormone deficiency may frequently show
alterations having to do with the epiphysis. For this
reason, children who limp or show unsteadiness in their
walking during growth hormone treatment should have
thorough check ups. Hypothyroidism may arise during
Humatrope treatment. Because untreated hypothyroidism
can prevent an optimal response to Humatrope, patients
should have periodic tests for thyroid functioning and
undergo thyroid hormone treatment when necessary.
Patients with psoriasis are also advised to have regular
check ups so as to avoid a possible aggravation of the
condition. In the event of sensitivity to the
accompanying diluent, the bottles may be reconstituted
with sterile water for injections. If Humatrope is
reconstituted this way, the solution must be
administered within 24 hours and any left over solution
thrown away. If, once reconstituted, the solution is not
administered immediately, it may be kept up to 24 hours
in the refrigerator at a temperature between +2 degrees
Celsius and +8 degrees Celsius. Humatrope’s effect on
the patient’s capacity to drive or operate machinery has
not been determined. back to top
Directions for usage of
Dosage and duration of treatment
are to be decided by the specialist according to the
needs of the patient.
Patients using Humatrope for growth
subcutaneous or intramuscular dosage is 0.18 mg/ kg of
body weight (0.48 IU/ Kg) per week, approximately
equivalent to 12 IU/m2 per week. The weekly dosage is to
be divided into either 3 intramuscular injections or 6
to 7 subcutaneous injections.
Patients with Turner’s syndrome
dosage is 0.3- 0.34 mg/ Kg of body weight (0.8- 0.9 IU/
Kg) per week, equivalent to 24- 28 IU m2 per week. The
weekly dosage is to be divided into 6-7 subcutaneous
injections, to be administered preferably in the
evening. With subcutaneous injection, it is advised that
the place of injection be varied so as to avoid the
onset of lipoatrophy. To prepare the Humatrope solution:
Inject 0.5- 2ml of the diluent into the bottle
containing the freeze-dried powder, directing the flow
of the liquid towards the sides of the bottle. Then
shake the bottle with a gentle rotating movement until
the contents are completely dissolved. DO NOT SHAKE VIGOROUSLY.
The use of sterile syringes and needles are recommended
for the injections. After reconstitution, the solution
must be transparent and without precipitates. If it is
opalescent or has precipitates, then it MUST NOT be used.
Clean the surface of the bottle’s rubber stopper with
antiseptic before and after using it to prevent
contaminating its contents. Syringes must have a volume
small enough to enable the prescribed dosage to be
extracted with reasonable accuracy. back to
reconstitution and administration of
Do not reconstitution or
administer this pharmaceutical product without first
receiving adequate instructions as to the correct
technique by the specialist. Follow the doctor’s
sterilizing technique by the specialist. Follow the
doctor’s sterilizing technique. Destroy and get rid of
syringes or needles following each use. Humatrope must
be kept in a cool place (from +2 degrees Celsius to +8
degrees Celsius) after reconstitution (refrigerator). DO
NOT FREEZE. ONCE RECONSTITUTED, HUMATROPE MUST BE USED
WITHIN 21 DAYS.
Reconstitution of the Humatrope
Reconstitute Humatrope only
with Humatrope diluent. Do not use
any other solution for reconstitution unless it is by
your doctor’s prescription. The doctor will also
decide the correct sizes of the syringe and needle and
the amount of diluent to add to the Humatrope bottle. ALWAYS WASH YOUR HANDS
Remove and throw away the
stoppers of the bottles of diluent and of Humatrope.
Clean the rubber covering of the bottles with cotton wad
soaked in alcohol (see figure 1 in pack). Remove the
protective covering of the needle and set it aside. Pull
the piston of the syringe until the same volume of air
is let in as the volume of diluent prescribed by the
doctor. Insert the needle into the rubber stopper of the
bottle of diluent and inject air into the bottle.
Holding the bottle upside down and making sure that
the needlepoint is in the solution, extract the amount
of diluent prescribed by the specialist (see figure 2 in
pack). Once you are sure there are no air bubbles left
in the syringe, turn the bottle right side up and
extract the syringe, taking care that the position of
the piston does not change.
Insert the same needle
into the bottle of Humatrope and gently turn the needle
point inwards towards the side of the bottle. Slowly
inject the diluent, directing the flow towards the side
(see figure 3 in pack). DO
NOT AIM IT IN THE DIRECTION OF THE WHITE POWDER AT THE
BOTTOM OF THE BOTTLE. To balance the
pressure and before removing the syringe from the
bottle, let in a volume of air equal to that of the
diluent just added. If the needle can become separated
from the body of the syringe, remove, destroy and throw
it away. If the needle and the syringe cannot be
separated, eliminate the entire unit.
bottle with a gentle rotating movement until the
contents are completely dissolved (see figure 4 in
Preparing the Humatrope
Do not use
Humatrope, if upon reconstitution, it is opalescent or
If the needle can be separated
from the syringe, apply a new needle before giving the
injection. If the syringe and needle from an inseparable
unit use another syringe for the preparation of the
Before and after administrating the
injection, the rubber stopper of the bottle must be
cleaned with alcohol or an alcohol based antiseptic
solution to avoid that repeated insertions of the needle
contaminate the contents.
Remove the cover of the
needle and let an amount of air equal to the amount of
Humatrope into the syringe.
Insert the cover of the
bottle of reconstituted Humatrope and inject air into
the bottle. Turn the bottle upside down and making sure
that the needlepoint is in the solution, inject the
exact dosage (see figure 2 in pack). Make sure that
there are no air bubbles in the syringe.
syringe and wrap up the needle. Write down the date of
reconstitution on the label of the bottle and eliminate
any diluent, which has not been used.
Put the unused
part of reconstituted Humatrope in the refrigerator and
use it within 21 days.
Destroy the needle or syringe
needle unit once finished.
Tap the spot chosen for the injection
gently with one finger.
Carefully clean the area
with a cotton wad, which has been soaked in alcohol,
making a circular movement, moving from the inside of
the circle outward.
Subcutaneous injections. Stabilize
the skin between the thumb and the index finger and
raise an ample portion of skin. Holding the needle at a
90-degree angle to the spot chosen for the injection,
insert the entire needle into the skin. Slowly inject
the liquid. Remove the needle quickly, exerting pressure
on the place chosen for the injection with a dry gauze
pad or a cotton wad. Rub for several seconds. Destroy the needle or the needle, syringe
injections. With the thumb and first two fingers,
press firmly against an ample portion of muscle mass,
such as the thigh. Holding the syringe at a 90-degree
angle to the spot chosen for the injection, insert the
entire needle into the skin. Holding the needle inside
the place chosen for injection, slowly pull back the
piston. Should blood appear in the syringe, remove the
needle, throw out the syringe with the pharmaceutical
product and prepare another injection. If blood does not
enter the syringe, slowly inject the solution. Pull the
needle out quickly, exerting pressure on the place of
injection with a dry gauze pad or cotton wad. Rub for
several seconds. Destroy the needle or the needle/
syringe unit when finished. If you are in any doubt,
consult your doctor.
In case of overdose using
Overdose may cause
hypoglycemia followed by hyperglycemia. Long term
overdose may result in symptoms of acromegaly, similar
to the effects of an excess of human somatotrophic
In the course of clinical
research studies on patients with growth hormone
deficiency, which has never been treated on patients
with Turner’s syndrome, a development of antibodies
against the growth hormone, has been detected, but which
has no effect on the rhythm of growth. Up to the
present, long term effects caused by the presence of
these antibodies have not been noted. Research into
antibodies against the growth hormone should be carried
out on all subjects who fail to respond to treatment. High doses of Humatrope deliberately
given to healthy adults have on rare occasions produced
the following effects- headache, local muscular pain,
weakness, mild hypoglycemia and glycosuria. In
studies on children with growth hormone deficiency, rare
cases have been reported of pain in the area of the
injection. 2.5% of those children treated has shown mild
transitory oedema in the early stages of treatment.
Should the patient notice any unpleasant side effect not
described in this leaflet, he should consult his
specialist or family doctor. Attention- Do not use this
or any medicine once its expiry date has passed.
Special notes on storage of
Store in the refrigerator at +2 degrees
Celsius to +8 degrees Celsius after reconstitution. Keep
the diluent and the reconstituted product from freezing.
If reconstituted with the accompanying diluent, the
product may be kept for 21 days in the refrigerator
without significant loss of
[somatropin (rDNA origin) for
injection] is therapeutically equivalent to the natural
GH produced by the body, made by recombinant DNA
technology. Saizen® is indicated for the treatment of
Growth Hormone deficiency in children and adults,
Turner’s syndrome and chronic renal failure.
Serono is a global biotechnology leader
with over 4,600 employees and worldwide revenues of USD
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It has eight biotechnology products on
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For more information on Serano Labs
check @ http://www.seronousa.com/products/pdf/saizen_pi.pdf
In adults, GENOTROPIN is prescribed for growth
hormone deficiency (GHD) that started either in
childhood or as an adult. Your doctor will do tests to
show if you have GHD.
Important Safety Information
Growth hormone (GH) therapy should not be used in
patients with cancer or who are receiving cancer
treatment. GH should not be used to increase height in
children after the growth plates have closed.
GH should also not be started in patients who are ill
because of surgery, trauma, or respiratory failure.
GH should not be used in children with PWS who are
severely overweight or have severe breathing
The 5.8-mg and 13.8-mg cartridges of GENOTROPIN
Lyophilized Powder contain m-Cresol and should not be
used by patients allergic to it.
Deaths have been reported with the use of growth
hormone in children with PWS. These children were
extremely overweight, had breathing problems, and/or
lung infection. All patients with PWS should be examined
for these problems. They should also establish healthy
If the patient has diabetes, insulin dosage may need
to be adjusted during therapy with GENOTROPIN.
Be sure to tell the doctor about any drugs the
patient is taking.
Tell the doctor if your child begins to limp or has
hip or knee pain while taking GENOTROPIN.
In children experiencing rapid growth, curvature of
the spine (scoliosis) may worsen.
A small number of patients treated with GENOTROPIN
have had increased pressure in the brain. Be sure to
tell the doctor if symptoms of this occur, such as
headache, visual changes, and nausea and/or
If the patient is pregnant or nursing, talk to the
In studies of GENOTROPIN in children with GHD, side
effects included injection site reactions, such as pain,
redness/swelling, inflammation, bleeding, scaring,
lumps, or rash. Other side effects were fat loss,
headache, blood in the urine, low thyroid activity, and
mildly increased blood sugar.
In studies of GENOTROPIN in children with PWS, side
effects included fluid retention, aggressiveness, joint
and muscle pain, hair loss, headache, and increased
pressure in the brain.
In studies of GENOTROPIN in children born SGA, side
effects included temporarily elevated blood sugar,
increased pressure in the brain, early puberty, abnormal
jaw growth, injection site reactions, growth of moles,
and worsening of scoliosis (curvature of the spine).
In studies of GENOTROPIN in adults with GHD, side
effects included fluid retention, joint or muscle pain,
stiffness, and changes in sensation. These events
usually went away with time.
Tell the doctor about these or any other side effects
that you notice.
Please read Full Prescribing