BRIEF INTRODUCTION
Ansomone is a kind of sterile, lyophilized formulation of Recombinant
Human Growth Hormone (HGH) with 191 amino acids, derived from engineering
E.coli, and it is identical to the natural growth hormone in amino
acid sequence and three-dimension structure. Ansomone is indicated
for growth failure due to endogenous growth hormone deficiency (GHD)
and Turner disease or Kidney failure. can be used to heal up the surgery
wound or burned wound and it has good effect to preservation for human
aging. Our manufacturing plants of are certified for GMP Standard
by SFDA.
SPECIFICATION AND
INTRODUCTION PRODUCT NAME
Generic name: Recombinant Human Growth Hormone for Injection
Trade name:
Chinese Phoneticize: Zhusheyong Chongzu Ren Shengzhangjisu
Composition in effect: Recombinant Human Growth Hormone
DESCRIPTION
White loose lyophilized powder.
PHARMACOLOGY AND TOXICOLOGY
Ansomone® exerts the same actions of endogenous human growth
hormone. It can stimulate proliferation and differentiation of epiphysis
chondrocyte, stimulate growth of cartilage matrix cells, stimulate
proliferation and differentiation of osteoblast; thus accelerate
the liner growth rate and improve epiphysis width. Ansomone®
can promote protein synthesis in whole body; reverse the negative
nitrogen equilibrium caused by wound and surgery; correct the hypoproteinemia
due to severe infection or hepatocirrhosis; stimulate synthesis
of immune globin and proliferation of lymphadenoid, macrophage and
lymphocyte, thus enhance the ability of infection resistance; stimulate
proliferation of collagenocyte, fibroblast and macrophage in sites
of burn and surgery, thus accelerate wound healing; promote synthesis
of cardiocytes, thus improve cardiac contractility and reduce cardiac
oxygen consumption; regulate lipometabolism, thus depress serum
cholesterol and low density lipoprotein's level; complement insufficiency
or deficiency of growth hormone, regulate adult's lipometabolism,
osteometabolism, heart and kidney function.
PHARMACOKINETICS
It is reported that the equal pharmacological effect could be achieved
via subcutaneous (sc) or intramuscular (IM) administration. Even
though sc may lead a higher concentration of GH in plasma, IM could
also yield the same IGF-I level. The absorption of GH is the relatively
slow, Cmax often occurs at 3-5 hours after injection. Clearance
of GH is via liver and kidney, the half-life of clearance is about
2-3hours. Uncatabolized GH excreted in urea is almost immeasurable.
All of the GH in circulation system exists as a complex form with
GH binding proteins that make the half-life of GH prolonged.
INDICATIONS
Ansomone® is indicated for the growth failure of children due
to endogenous growth hormone deficiency (GHD), chronic renal insufficiency
(CRI) and Turner's syndrome. Ansomone® is indicated for severe
burn.
More information
USAGE
When reconstitution, 1ml water for injection should be injected
along the bottle wall, then swirl the vial with a gentle rotary
motion until the contents are completely dissolved, do not shake
violently.
The recommended dosage of Ansomone® for the treatment of children
growth failure is 0.1~0.15IU/kg daily subcutaneous administration
for 3 months to 3 years. Therapy regimen could be modified according
to experienced doctor's suggestion. The recommended dosage of Ansomone®
for the treatment of severe burn is 0.2~0.4IU/kg daily subcutaneous
administration for 2 weeks.
ADVERSE REACTIONS
Growth hormone may cause transient hyperglycemia; it can be recovered
as the administration proceeded or terminated.
Adverse reactions occurred in about 1% short stature children in
clinical trial. Common adverse reactions include slight pain, tingle,
turgescence around the injection site and peripheral edema, arthralgias.
All of those adverse reactions often occurred at the beginning of
treatment, and were temporal and tolerable. Long-term and high dosage
administration of hGH may develop the antibodies in a few patients.
However, the antibodies concentration could be rarely up to as high
as 2mg/L that might affect the therapeutic efficiency.
CONTRAINDICATIONS
1. Ansomone® should not be used in children whose epiphysis
had been closed.
2. Ansomone® should not be used in cancer patients.
3. Ansomone® should not be used in patients in acute shock stage
with severe infection.
WARNINGS AND PRECAUTIONS
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hGH therapy should be conducted on exactly diagnosed
GHD patients under advice of experienced doctor. |
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For diabetes patients, dosage of anti-glucourea drugs should
be adjusted during HGH therapy. |
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For patients whose GHD were caused by encephaloma or encephalic
wound, the progress and the relapse possibility of potential
diseases should be closely monitored. |
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For ACTH deficiency patients, dosage of ATCH should be adjusted
because the growth improvement effect of HGH could be inhibited
by simultaneous using of ACTH. |
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Thyroid gland function should be tested regularly because
clinical hypothyroidism may occur to some patients during HGH
therapy. For those hypothyroid, thyroid supplementation is necessary
for ensuring the therapeutic effects of HGH. |
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Careful consideration should be taken if claudicating occurred
during HGH therapy because the patients who suffered from endocrine
system diseases (including GHD) have such a tendency that their
epiphysis plates of femur are relatively easy to separate. |
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Growth hormone may lead to over insulin state, attention should
be paid to if lower glucose intolerance appeared. |
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Do not take over-dose of HGH, one time over-dose HGH administration
can lead to low blood sugar and succeeded with high blood sugar.
Long-term over -dose HGH administration can lead to acromegaly. |
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Injection site should often variation in case lipoatrophy. |
PREGNANT AND BABY-NURSING WOMEN USAGE:
It is not recommended for pregnant and nursing women to accept HGH
therapy.
PEDIATRICS USAGE:
Response to HGH of children is similar to that of adults in pharmacology,
toxicology and pharmacokinetics, HGH is safe for pediatric use.
OLD PATIENTS USAGE:
Response to HGH of old patients is similar to that of adults in
pharmacology, toxicology and pharmacokinetics, HGH is safe for geriatric
use.
INTERACTION WITH OTHER DRUGS:
Responses to HGH therapy might be inhibited by glucocorticoid, so
that hydrocortisone dosage would be lower than 10~15mg/m2 of body
surface during HGH therapy. Simultaneous using of non-androgenic
steroid during HGH therapy can accelerate growth rate.
OVERDOSAGE:
There is yet no report about over dosage of HGH; however, over dosage
may cause some side effects, such as hypoglycemia at the beginning
then succeeded with hyperglycemia. Long-term over dosage using of
HGH can lead to acromegaly.
VIAL SIZE: 2, 4 IU/vial
STORAGE:
Keep at 2~8°C away from light. The reconstituted solution mixed
with Sterile Water for Injection can be stored at 2~8? for 48 hours,
do not be frozen.
EXPIRY: 2 years
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