this should help clear it up
Bro you may still be ok, I did some research for you on it.
I month max on the shelf life before Mixed..
check the bottom few paragraphs. Id still keep it in the fridg at all times if it were mine.
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1.NAME OF THE MEDICINAL PRODUCT
FITTROPIN (Recombinant human growth hormone (rDNA origin) for injection). Powder for injection 4IU.
2.QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE INGREDIENT
Powder for injection substance 4IU
One vial contains Powder for injection of (rDNA origin) 4IU.
3.PHARMACEUTICAL FORM
Powder for injection prepared with supplied solvent,with or without preservative, for subcutaneous
(s.c.) administration.
4.PHARMACO-THERAPEUTIC GROUP
Human Growth Hormone, HGH (rDNA origin).
FITTROPIN stimulates linear growth and increases growth rate in children who lack adequate
endogenous growth hormone. In adults with growth hormone deficiency, FITTROPIN reduces fat mass,
increases muscle mass and improves energy, vitality and subjective well-being. In patients
suffering from severe burns, AIDS associated muscle wasting, or undergoing major operations,
FITTROPIN promotes wound healing, attenuates the protein-catabolic response and improves whole-body
nitrogen economy after operation.
5.HOLDER OF THE AUTHORIZATION
FITTROPIN is manufactured by Kexing BioTech Co., LTD, Shenzhen, China. It is the
largest biotech company in China
6.THERAPEUTIC INDICATIONS
Growth disturbance due to insufficient secretion of growth hormone or associated with gonadal
dysgenesis or Turner¡¯s syndrome which is a chromosome aberration.
Growth disturbance in prepubertal children with chronic renal insufficiency.
Replacement therapy in adults with pronounced growth hormone deficiency.
Promote wound healing and attenuate catabolic responses in severe burns, sepsis, multiple trauma,
major operations, acute pancreatitis and intestinal fistula.
Topical application to promote wound healing in acute wound or chronic ulcer, such as burns,
diabetic foot ulcer, chronic venous ulcer and decubital ulcer.
7.CONTRAINDICATIONS
FITTROPIN should not be used when there is any evidence of activity of brain tumor. Intracranial
lesions must be inactive and antitumour therapy completed prior to starting therapy.
FITTROPIN should not be used for growth promotion in children with closed epiphyses.
8.WARNINGS AND PRECAUTIONS
The diagnosis should be confirmed before treatment starts. Therapy with Fittropin should be
directed by suitably qualified physicians. In diabetes mellitus, the dose of insulin might require
adjustment by your physician before FITTROPIN treatment starts.
Experience in adult GHD patients above 60 years is lacking.
Experience with prolonged treatment in adults is limited.
In chronic renal insufficiency the renal function should be investigated before start of the
treatment.
The treatment should be discontinued after renal transplantation.
9.INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
See under 8.
10.PREGNANCY AND LACTATION
No clinical experience of the use in pregnant women is available. Treatment with FITTROPIN should
be interrupted if pregnancy occurs. Information is lacking whether peptide hormones pass over into
the breast milk but absorption in the gastro-intestinal tract of the infant of intact protein is
extremely unlikely.
11.EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
The ability to react is not influenced by Fittropin.
12.DOSAGE AND ADMINISTRATION
The dosage is individual, based on body weight or body surfaces area and should be determined by
your physician.
Growth disturbance due to insufficient secretion of growth hormone in children: Generally a dose
of 0.5-0.7 IU/kg/wk or 14-20 IU/m2/wk is recommended. Even higher doses have been used.
Gonadal dysgenesis (Turner¡¯s syndrome): A dose of 1.0 IU/kg/wk or 28 IU/m2/wk is recommended.
Chronic renal insufficiency: A dose of 30IU/m2/wk (approximately 1 IU/kg/wk) is recommended.
Higher doses can be needed if growth velocity is too slow. A dose correction can be needed after
six months of treatment.
Growth hormone deficiency in adults: An initial dose for about four weeks of 0.125 IU/kg/wk, is
recommended. The daily dose should then be modulated according to the side effects of the patients
as well as determination of Insulin like Growth Factor-l (IGF-I) in serum as guidance.
The weekly dose should be divided into 7 s.c. injections.
The injection site should be varied to prevent lipoathrophy.
If treatment has been forgotten one day do not take double doses the next day but continue the
treatment according to the directions.
For severe burns or multiple injuries, it is recommended an initial dose of 8IU/day followed by
16IU/day after patients¡¯ blood glucose level is stabilized. Typical treatment starts in 6 days
after burns or injuries and treatment length is about 15-20 days.
For major operations, 12IU/day for a period of 10 days is recommended. Typical treatment starts in
2-3 days after operations.
For topical application to wound or ulcer surface, a dose of 0.2IU/cm2 is recommended at three
times a day. Length of treatment depends on healing time.
13.OVERDOSAGE
No overdose or intoxication is known.
If an overdose of FITTROPIN has been injected contact should be taken with your physician.
14.ADVERSE REACTIONS
Side effects have been noted in approximately 10% (most common local skin reactions) of the
patients participating in clinical trials in children with short stature.
In clinical trials in adults side effects have been noted in approximately 30 to 40% of the
patients, primarily related to symptoms of fluid retention (oedema). These events have an early
onset after initiation of therapy, but with a reduction in incidence and prevalence over time and
rarely influencing daily activities.
FITTROPIN has given rise to the formation of antibodies in very few patients. This has no
influence on the treatment result.
It has been reported that patients may develop hypothyroidism during treatment with FITTROPIN
which should be considered by your physician.
If nausea and/or vomiting, severe and recurrent headache especially in combination with visual
problems occur take contact with your physician.
15.INCOMPATIBILITIES
Incompatibilities have not been reported for combined use of FITTROPIN with other medicaments or
medical solution.
16.SHELF LIFE
The powder for injection is assigned a shelf life of 24 months when stored cold at +2 - +8¡æ.
Storage for one month can take place in room temperature.
Reconstituted FITTROPIN with preservative may be stored cold at +2 - +8¡æfor 2 weeks protected
from light.
17.SPECIAL PRECAUTIONS FOR STORAGE
Frozen powder should not be used. Store cold at +2 - +8¡æ.
18.INSTRUCTIONS FOR USE/HANDLING
Vials: add solvent to vial with powder for injection. Gently dissolve the drug with a slow,
swirling motion. Do not shake vigorously, or the active ingredient might denature.
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sorry bro.
