Human growth hormone, Bionitropin, 100 IU, Ampoules 10 ml, 10 pcs

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Brand: BionichePharma
55.00€
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PRODUCT OVERVIEW & COMPOSITION

Brand / Manufacturer: Bioniche Pharma (Bionitropin)

Active Ingredient: Recombinant Human Growth Hormone / Somatropin (3.33 mg / 10 IU per vial)

Pharmacological Class: Synthetic Peptide Hormone / Recombinant Somatropin ($191\text{-Amino Acid}$ Sequence)

Bionitropin by Bioniche Pharma is a high-purity recombinant human growth hormone (rHGH) supplied as a white lyophilized powder for reconstitution. Containing an exact sequence of 191 amino acids identically matching endogenous human growth hormone (molecular weight 22,125 Daltons), Bioniche Pharma Bionitropin is formulated with medical glycine (2 mg) and medical mannitol (22 mg) per vial to stabilize the protein structure for optimal therapeutic biological activity.

CLINICAL PHARMACOLOGY & MECHANISM OF ACTION

Bioniche Pharma Bionitropin exerts complex acute and long-term metabolic actions by binding to specific growth hormone receptors present on chondrocytes, osteoblasts, hepatocytes, adipocytes, and fibroblasts. Its physiological effects are primarily mediated through hepatic and peripheral production of Insulin-like Growth Factor-1 (IGF-1):

  • Linear & Skeletal Growth: Stimulates long bone growth at the epiphyseal plates in pediatric patients, drives cellular division, enhances amino acid uptake, and increases muscle cell number and size, internal organ dimensions, and red blood cell mass. It causes marked nitrogen retention, leading to a decline in blood urea nitrogen (BUN) and urinary nitrogen excretion.
  • Carbohydrate Metabolism: Induces brief immediate insulin-like effects followed by pronounced anti-insulin actions. Large doses decrease peripheral glucose utilization, provoke hyperinsulinemia, and may impair glucose tolerance or induce insulin resistance. In hypopituitary children with fasting hypoglycemia, Bionitropin therapy restores euglycemia.
  • Lipid Metabolism: Promotes lipolysis, mobilization of fat stores, and increases plasma free fatty acids, producing a noticeable reduction in subcutaneous fat mass and a net decrease in mean serum cholesterol levels.
  • Mineral & Connective Tissue Metabolism: Induces retention of sodium, potassium, and inorganic phosphorus while stimulating renal tubular reabsorption of phosphate. Enhances intestinal calcium absorption, increases synthesis of chondroitin sulfate and collagen, and elevates urinary hydroxyproline excretion.
INDICATIONS & CLINICAL USE
  • Treatment of pediatric growth failure caused by endogenous growth hormone deficiency (GHD).
  • Adult growth hormone deficiency secondary to hypothalamic-pituitary disease, trauma, surgical intervention, or radiation therapy.
  • Management of HIV-associated muscle wasting (cachexia) and short bowel syndrome.
  • Therapeutic support in non-GHD short stature, Turner syndrome, or chronic renal insufficiency under specialized medical supervision.
CONTRAINDICATIONS
  • Active proliferative or preproliferative diabetic retinopathy.
  • Active neoplastic disease or evidence of growing intracranial tumors. Malignancies must be inactive and anti-tumor therapy completed prior to initiating Bionitropin therapy.
  • Acute critical illness due to complications following open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure.
  • Prader-Willi syndrome in pediatric patients who are severely obese or have severe respiratory impairment.
  • Known hypersensitivity to Somatropin, glycine, mannitol, or reconstitution diluents (e.g., benzyl alcohol in bacteriostatic water).
PRECAUTIONS & CLINICAL MONITORS
  • Glucose Tolerance & Insulin Sensitivity: Because Somatropin induces anti-insulin activity, patients with diabetes mellitus or impaired fasting glucose require regular blood glucose monitoring. Insulin or oral hypoglycemic dosages may require adjustment.
  • Thyroid & Adrenal Function: Somatropin therapy may accelerate peripheral conversion of T4 to T3 or unmask central hypothyroidism. Periodic thyroid function tests (free T4, TSH) and adrenal axis evaluations are indicated.
  • Epiphyseal Closure Monitoring: In pediatric cases, treatment must be closely monitored by a pediatric endocrinologist and discontinued upon complete epiphyseal fusion.
ADVERSE REACTIONS
  • Metabolic & Fluid Balance: Peripheral edema, fluid retention, joint stiffness, arthralgia, myalgia, and transient carpal tunnel syndrome due to sodium and water conservation.
  • Endocrine & Dermatological: Impaired glucose tolerance, hyperglycemia, localized lipoatrophy or lipohypertrophy at injection sites (preventable by rotation of injection sites), and injection site pain.
  • Rare & Severe: Benign intracranial hypertension (pseudotumor cerebri) presenting with headache, visual disturbances, nausea, and vomiting.
DOSAGE & RECONSTITUTION DIRECTIONS

Bioniche Pharma Bionitropin is administered via subcutaneous or intramuscular injection after reconstitution with appropriate diluent (such as bacteriostatic water or sterile water for injection):

  • Dosing Protocol: Dosages must be highly individualized based on patient body weight, body surface area, clinical diagnosis, and serum IGF-1 levels as determined by the supervising physician.
  • Reconstitution Technique: Direct the diluent stream against the glass vial wall. Gently swirl with a slow circular motion until the lyophilized powder completely dissolves. Do not shake vigorously to avoid denaturation of the peptide chain.
STORAGE & HANDLING
  • Unreconstituted Lyophilized Powder: Store cold at +2°C to +8°C (+36°F to +46°F) with a shelf life of up to 36 months. Can be safely stored at room temperature (up to 25°C) for up to 1 month without potency loss; prolonged exposure past 1 month diminishes biological activity.
  • Reconstituted Solution: After mixing with bacteriostatic water, store refrigerated at +2°C to +8°C for up to 2 weeks, strictly protected from direct light exposure. Do not freeze. Keep strictly out of reach and sight of children.