BIONITROPIN (10 IU X 10 VIALS)

BIONITROPIN

Recombinant Human Growth Hormone

DESCRIPTION

BIONITROPIN is a necombinant human growth hormone (rHGH) for injection. It is a white lyophilized powder consisting of the identical sequence of 191 amino acids of human growth hormone. The molecular formula is CoroHisaNaOmeSr. Its molecular weight is 22,125 Daltons. Each vial also contains 2 mg of medical glycine and 22 mg of medical mannitol.

FORMULATION

Each vial contains

3.33mg (10 IU) Somatropin (Recombinant Human Growth Hormone)

PHARMACOLOGY

Pharmacodynamic

BIONITROPIN does not differ significantly from human growth hormone in its metabolic actions. These effects are bolth acute (wilhin 2 hours) and long term.

BIONITROPINÂhas the following pharmacological actions:

Linear and Skeletal growth (Primary action)

• BIONITROPIN acts through specific growth hormane receptors which are present in chondrocytes, osteablasts, hepatocyfes, adipocytes and fibroblasts. These receptors are also found in other tissues such as the brain and gastrointestinal tract where the role of growth hormone is not clear.

• Growth homone stimulates skeletal and soft tissue growth by promating cell divisian, amino acid uptake and protein synthesis. Its actions are predominantly mediated by hepatic and peripheral insulin – like growth factor-1 (IGF-1) production. This results in:

– Skeletal growth in pediatric patients with growith hormone deficiency by its effect on the apiphyseal growth plates of long bones. These is an increase in growith rate and IGF-1 levels similar to that seen with hurnan growth homone.

– Increase in the number and size of musale cells.

– Increase in intemal organ size and red cell mass.

-Increase cellular protein synthesis due to nitrogen retention lending to a positive nitrogen balance as demonstrated by a decline in urinary nitrogan excretion and blood urea nitrogen (BUN).

Carbohydrate metabolism

• BIONITROPIN’s actions are predominantly mediated by hepatic and peripheral insulin-ike growth factor- 1 (IGF-1) production leading to immediate but brief insulin-like aclions followed by more significant anti-insulin-like effects witch include decreased glucose utilization (hyperglycemia) and lipolysis within 2-4 hours, Large doses of growth hormone may impair glucose tolerance and induce insulin resistance The exact mechanism is not known. Children with hypopituitariam sometimes experience fasting hypoglycemia that is improveid by BIONITROPIN therapy.

• In short children who are not growth hormone-deficient, BIONITROPIN may provoke hyperinsulinemia without impairment of glucose tolerance.

Lipid metabolism

• Growth hormone administration causes reduction of body fat stores, mobilization of lipid stores and an increase in plasma fatty acids secondary to BIONITROPIN ‘s anti-insulin-like effects. The lipolytic effect is seen in growlth hormone-deficient children during the early months of treatment as loss of subcutaneous fat.

• Mean cholesterol levels are decreased in patients given BIONITROPIN.

Mineral metabolism

• Growth hormone induces sodium, potassium and phosphorus retention which is thought to be caused by cell growth.

• Serum inorganic phosphate increases in growth-hormone deficient patients after BIONITROPIN administration. This is attributed to metabolic activity associated with bone growth and an increased tubular reabsorption of phosphate by the kidneys.

• Serum calcium is nat significantly affected. Urinary calcium excretion increases there is a simultaneous increase in its absorption from the intestine.

Connective tissue metabolism

• BIONITROPIN stimulates the synthesis of chondroitin sulfate and collagen as well as the urinary excretion of hydroxyproline.

STORAGE

The powder for injection is assigned a shelf life of 36 months, when stored cold at +2 to +8° Celsius rHGH can be safely stored in a normal room temperature for 1 month, but if this period would exceed 1 month-then the rHGH abilities can decrease. Reconstituted BIONITROPINE (the powder mixed with the bacteriostatic water) may be stored cold at +2 to +8° for 2 weeks protected from light. Keep reach out of children.