| HUMATROPE®/
HGH Information on Anti Aging
Humatrope Ingredients:
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 injections.
Pharmaceutical Classification of Humatrope:
Sterile freeze-dried powder of systemic hormone preparation.
Directions for usage of Humatrope:
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).
Contraindications using Humatrope:
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:
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 intramuscular injections. back
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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 present.
Using Humatrope during pregnancy and nursing:
Studies on 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 caution. back to top
Interactions using Humatrope:
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 Humatrope:
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 Humatrope:
Dosage and duration of treatment are to be decided by the specialist
according to the needs of the patient.
Patients using Humatrope for growth hormone deficiency:
The recommended 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 administering Humatrope:
The recommended 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
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Directions for reconstitution and administration of Humatrope:
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)
before and after reconstitution. DO NOT FREEZE. ONCE RECONSTITUTED, HUMATROPE
MUST BE USED WITHIN 14 DAYS.
Reconstitution of the Humatrope bottle:
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 FIRST
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. back to top
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.
Shake the bottle with a gentle rotating movement
until the contents are completely dissolved (see
figure 4 in pack). back to top
Preparing the Humatrope injections:
Do not use Humatrope, if upon reconstitution,
it is opalescent or contains precipitates.
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 injection.
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.
Remove the 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 14 days.
Destroy the needle or syringe needle unit once
finished. back to top
Humatrope Injections:
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 unit.
Intramuscular 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. back to
top
In case of overdose using Humatrope:
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 hormone.
Humatrope Side Effects:
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 Humatrope:
Store in the refrigerator at +2 degrees Celsius to +8 degrees Celsius.
Keep the diluent and the reconstituted product from freezing. If reconstituted
with the accompanying diluent, the product may be kept for 14 days in
the refrigerator without significant loss of properties.More
on Humatrope HGH Anti Aging
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