BIOTROPIN HGH 40 IU

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COMPOSITION:

BIOTROPINHGH 40 IU •

Recombinant Human Growth Horomone

(Somatropin rONA origin 191 Amino acids) for injection USP Molecular Formula:C,.H.,N,Ov,

Active Life:Up to 2 hours

Detectionlime:12 hours

DESCRIPTION:

Biotropin (recombinant Human Growth Hormone-rONA origin) is a human growth hormone produced by recombinant DNA technology. It has 191 amino acid sequence and its structure are identicalto the dominant form of this human pituitary growth hormone.It has a molecular weight of 22,125 daltons. Biotropin(rONA origin HGH) is a sterile,non-pyrogenic,white lyophilized powder intended for subcu-taneous or intramuscular injection,after recon­ stitution with sterileWater for Injection.

INSTRUCTIONS FOR RECONSTITUTION AND INJECTION: Powder must be dissolved only with the solvent provided.

WARNING: BIOTROPIN HGH by nature has a half-life of less than 20 minutes by its self. The molecule was so small it would escape the blood stream very rapidly.

Step 1: Apply the needle to the syringe HGH 41U ampoule- Number111,Solvent ampoule- Number 112

Step 2: Break the top of the ampoule#2 containing the solvent. Remove the plastic cover of the needle.Make sure the needle is well applied to the syringe.Slowlyabsorb all the solvent.

Step 3: Break the top of the ampoule #l containing the solution. Inject all the solvent to the ampoule#1 HGH 41U. This will create a 41U(1,11 mg!ml) solution.To prevent foaming,the solvent should beinjected into the ampoule byaiming the stream ofliquid against the glass wall.

Step 4: Following reconstitution,the ampoule 111 should be swirled with a GENTLE rotary motion until the contents are completelydissolved.DO NOT SHAKE.The resulting solution should be clear and colorless,without particulate matter.

Step 5: Make sure the needleis well applied to the syringe. Slowly absorb all the solution ofampoule#1 HGH 41U in syringe.

Step 6: Insert the needle under the skin.Deliver the dose by pressing the push button.Leave the needle under the skin for at least 3 seconds to ensure that the full dose has been delivered. Remove the needle from the skin.

CLINICAL PHARMACOLOGY: Somatropin (as well as endogenous HGH) binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharma- codynamic effects.Some of these pharmacody­ namic effects are primarily mediated by IGF-1 produced in the liver and also locally (e.g.,skeletal growth,protein synthesis),while others are primarily a consequence of the direct effects of somatropin.

TISSUE GROWTH: The primary and most intensively studied action of somatropin is the stimu­ lation of linear growth.This effect is demonstrated in children with GHD. SkeletalG......th The measurable increase in bone length after administration of somatropin results from its effect on the cartilaginous growth areas of long bones. Studies in vitro have shown that the incorporation of sulfate into proteogly­ cans is not due to a direct effect of somatropin,but rather is mediated by the somatomedins or insulin-like growth factors (IGFs).The somatomedins, among them IGF-1,are polypeptide hormones which are synthesized in the liver,kidney, and various other tissues.IGF-IIevels are low in the serum of hypopituitary dwarfs and hypophysectomized humans or animals, and increase after treatment with somatropin.

Cell Growth It has been shown that the total number of skeletalmuscle cells is markedly decreased in children with short stature lackin endogenous GH compared with normal children, and that treatment with somatropin results in an increase in both the number and size of muscle cells. Organ Growth Somatropin influences the size of internal organs, and it also increases red cell mass. Protein Metabolism linear growth is facilitated in part by increased cellular protein synthesis. This synthesis and growth are reflected by nitrogen retention which can be quantitated by observing the decline in urinary nitrogen excretion and blood urea nitrogen following the initiation of somatropin therapy. Carbohydrate Metabolism Hypopituitary children sometimes experience fasting hypoglycemia that may be improved by treatment with somatropin.ln healthy subjects,large doses of somatro­ pin may impair glucose tolerance. Although the precise mechanism of the diabetogenic effect of somatropin is not known,it is attributed to blocking the action of insulin rather than blocking insulin secretion. Insulin levels in serum actually increase as soma­ tropin levels increase. Administration of human growth hormone to normal adults and patients with growth hormone deficiency results in increases in mean serum fasting and postprandial insulin levels,although mean values remain in the normal range. In addition, mean fasting and postprandial glucose and hemoglobin A1c levels remain in the normal range. Lipid Metabolism Somatmpin stimulates intracellular lipolysis, and administration of somat­ ropin leads to an in- crease in plasma free fatty acids and triglycerides. Untreated GHD is associated with Increased body fat stores, including increased abdominal visceral and subcutaneous adipose tissue. Treatment of growth hormone deficient patients with somatropin results in a general re-duction of fat stores, and decreased serum levels of low density lipopro­ tein (LDL) cholesterol. Connective1issue Metabolism Somatmpin stimulates the synthesis of chondroitin sulfate and collagen, and increases the urinary excretion of hydroxyproline. INDICATIONS: HGH 41U is a prescription product for the treatment of growth failure in children: Who do not make enough growth hormone on their own. This condition is called growth hor- mane deficiency (GHD). With a genetic condition called Prader-Willi syndrome (PWS). Growth hormone is not right for all children with PWS.Check with your doctor. Who were born smaller than most other babies born after the same number of weeks of preg- nancy. Some of these babies may not show catch-up growth by age 2 years.This condition is called small for gestational age (SGA).

With a genetic condition called Turner syndrome (TS). With idiopathic short stature (ISS),which means that they are shorter than 98.8% of other children ofthe same age and sex; they are growing at a rate that is not likely to allow them to reach normal adult height, and their growth plates have not closed.Other causes of short height should be ruled out.ISS has no known cause. HGH 41U is a prescription product for the replacement of growth hormone in adults with growth hormone deficiency (GHD) that started either in childhood or as an adult.Your doctor should do tests to be sure you have GHD,as appropriate.

CONTRAINDICATIONS: This list presents the most serious and/or most frequently observed adverse reactions during treatment with somatropln:

• Sudden death in pediatric patients with Prader-Willi syndrome with risk factors including severe obesity, history of upper airway obstruction or sleep apnea and unidentified respira-tory infection ., Intracranial tumors, in particular meningiomas, in teenagers/young adults treated with radiation to the head as children for a first neoplasm and somatropin

• Glucose intolerance including impaired glucose tolerance/impaired fasting glucose as well as overt diabetes mellitus Intracranial hypertension • Significant diabetic retinopathy

• Slipped capital femoral epiphysis in pediatric patients

Progression of preexisting scoliosis in pediatric patients

• Fluid retention manifested by edema,arthralgia,myalgia,nerve compres­

sion syndromes including carpaltunnel syndrome I paraesthesias

• Unmasking of latent central hypothyroidism

• Injection site reactions/rashes and lipoatrophy (as well as rare general­

ized hypersensitivity reactions) • Pancreatitis

IMPORTANT: USE COMPLETELY AFTER RECONSTITUTION. RECONSTITUTED SOLUTION IS STABLE FOR 20 DAYS WHEN REFRIGERATED.

HOW SUPPLIED: Ampoules package containing: 1 mllyophilized multiple dose ampoule containing:HGH 41U Somatropin 1 mlampoule of solvent containing: water for injection with sodium chloride 0.56% and benzyl alcohol 0.9%, NDC 002Hl345-11. When reconstituted,each 1 mal mpoule contains: HGH 41.U. Somatropin (1,11 mg) Monobasic sodium phosphate 3 mg Dibasic sodium phosphate 4.4 mg Sodium chloride 0.56% Benzylalcohol 0.9% If required pH adjusted with sodium hydroxide and/or phosphoric acid.

Storage: After reconstitution,may be stored for a maximum of 30 days in a refrigerator at 2°(- goc. Store vials In an upright position. Store in a refrigerator (2"C- s•q. Keep in the outer carton in order to protect from sun light. For one month can be stored at room temperature. For shelf-life please refer to the imprint on the pack. Keep out of reach of children.

Manufactured and Distributed by: Biotech Pharmaceuticals Ltd Date of approval:03/04/201 B