Somatropin Vials

Somatropin Vials

Description:

Somatropin Vials (somatropin 4 i.u. = 1.6 mg vial) by SEDICO are a prescription injectable medicine containing synthetic human growth hormone (recombinant somatropin). They are used under medical supervision to treat growth hormone deficiency and related growth disorders in children and adults. Somatropin stimulates linear bone growth, increases lean body mass, and supports normal metabolic functions by acting directly on growth hormone receptors and indirectly via insulin-like growth factors (IGF-1, IGF-2). This product is intended for therapeutic use only and must be used exactly as prescribed by an endocrinologist or qualified healthcare professional.

Indications:

• Treatment of growth hormone deficiency (GHD) in children with short stature due to inadequate endogenous growth hormone secretion.
• Treatment of growth hormone deficiency in adults diagnosed with severe GHD of childhood or adult onset, confirmed by appropriate stimulation tests.
• Support of linear bone growth, skeletal development, and proportional body growth in pediatric patients with documented GHD.
• Improvement of body composition in adults with GHD by increasing lean body mass and reducing fat mass, as directed by a specialist.
• Management of symptoms associated with GHD such as reduced growth velocity in children, decreased muscle mass, low energy, and impaired quality of life in adults, when confirmed as due to GHD.

Active Ingredients / Key Components:

• Somatropin (recombinant human growth hormone) – 4 i.u. (equivalent to 1.6 mg) per vial.
• Excipients: Specific inactive ingredients (such as buffers, stabilizers, and preservatives) are not provided in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.). Please refer to the official package insert for the complete excipient list.

Dosage & Administration / How to Use:

• Somatropin Vials are for parenteral injection only, usually administered as a subcutaneous injection. Intramuscular administration may be used if specifically directed by the physician.
• The dose, frequency, and duration of treatment are individualized based on body weight or body surface area, clinical response, and laboratory monitoring, and must be determined by an endocrinologist.
• Typical pediatric dosing for GHD is weight-based (for example, several micrograms/kg/day), but exact dosing must follow the prescribing physician’s protocol and official product labeling. Do not adjust the dose without medical advice.
• For adults with GHD, therapy usually starts with a low dose and is titrated gradually according to clinical response and IGF-1 levels. The exact dose regimen must be prescribed by the treating physician.
• Reconstitution: The vial must be reconstituted with the recommended diluent (usually sterile water for injection or bacteriostatic solvent) as specified in the official package insert. Gently swirl the vial to dissolve; do not shake vigorously to avoid protein denaturation.
• Inspect the solution after reconstitution. Use only if the solution is clear and free from particles or discoloration.
• Administer injections at the same time each day, preferably in the evening, or as directed by your doctor to mimic natural growth hormone secretion.
• Rotate injection sites (abdomen, thigh, buttock, upper arm) to reduce the risk of lipoatrophy or lipohypertrophy at the injection site.
• Use aseptic technique: wash hands thoroughly, use sterile syringes and needles, and clean the injection site with an antiseptic swab before injection.
• Do not use more than the prescribed dose. If a dose is missed, contact your healthcare provider for instructions. Do not double the dose to make up for a missed injection unless specifically advised.

Clinical Benefits:

• Promotes linear bone growth in children with growth hormone deficiency, helping improve height and skeletal development when started early and used consistently.
• Increases lean body mass and supports muscle growth, strength, and physical performance in patients with confirmed GHD.
• Helps reduce body fat mass and improve body composition in adults with growth hormone deficiency, under specialist supervision.
• Supports protein synthesis, nitrogen retention, and overall anabolic metabolism, contributing to better tissue repair and growth.
• Improves quality of life parameters in adults with GHD, including energy levels, well-being, and exercise capacity, when used as part of a comprehensive treatment plan.

Warnings & Contraindications:

• Somatropin is a prescription-only medicine and must be used strictly under the supervision of a qualified physician experienced in managing growth hormone disorders.
• Contraindicated in patients with active malignancy (cancer). Any pre-existing malignancy must be inactive and under control before starting therapy. If signs of tumor recurrence appear, treatment must be discontinued.
• Contraindicated in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure.
• Do not use in children with closed epiphyses (completed growth) for height increase purposes.
• Use with extreme caution in patients with diabetes mellitus or impaired glucose tolerance; somatropin may reduce insulin sensitivity and increase blood glucose levels. Dosage adjustments of antidiabetic medications may be required.
• Monitor patients with a history of intracranial lesions or increased intracranial pressure; discontinue if signs of benign intracranial hypertension (e.g., severe headache, visual changes, nausea/vomiting) occur.
• Use with caution in patients with hypothyroidism, adrenal insufficiency, or other pituitary hormone deficiencies. These conditions must be adequately treated before and during somatropin therapy.
• May cause fluid retention; use cautiously in patients with pre-existing edema, heart failure, or renal impairment.
• Not recommended for use in pregnancy or breastfeeding unless clearly needed and prescribed by a specialist. Consult your doctor if you are pregnant, planning pregnancy, or nursing.
• Consult your doctor before use if you have liver disease, kidney disease, diabetes, history of cancer, intracranial tumors, or any serious chronic illness.
• Do not share needles, syringes, or vials with others to prevent transmission of infections.
• Keep out of reach of children.
• Not intended to diagnose, treat, cure, or prevent any disease without proper medical evaluation and prescription.

Side Effects:

• Common side effects may include injection site reactions (pain, redness, swelling), mild edema (swelling of hands, feet, or ankles), joint pain (arthralgia), muscle pain (myalgia), and stiffness.
• Metabolic effects such as increased blood glucose, insulin resistance, or changes in lipid profile may occur; regular monitoring is recommended, especially in patients with diabetes or risk factors.
• Headache, nausea, fatigue, and paresthesia (tingling or numbness) can occur, particularly at the start of therapy or with dose increases.
• In children, rare cases of slipped capital femoral epiphysis and progression of scoliosis have been reported; report hip or knee pain and limping immediately.
• Benign intracranial hypertension (pseudotumor cerebri) may present with severe or persistent headache, visual disturbances, nausea, or vomiting. If these occur, contact your doctor immediately and discontinue use until evaluated.
• Allergic reactions are rare but may include rash, itching, swelling, dizziness, or difficulty breathing. Seek emergency medical attention if signs of a severe allergic reaction appear.
• If you experience shortness of breath, chest pain, sudden swelling, severe abdominal pain, or any unusual or severe symptoms, stop using the product and seek urgent medical care.

Storage Instructions:

Store Somatropin Vials according to the manufacturer’s instructions. Typically, unopened vials should be stored in a refrigerator at 2–8°c, protected from light. Do not freeze. After reconstitution, storage conditions and in-use shelf life depend on the type of diluent used and must follow the official package insert. Keep the vial in its outer carton to protect from light. Store in a cool, dry place away from direct sunlight and heat sources. Keep container tightly closed and out of reach of children. Do not use after the expiry date printed on the pack.

Specifications:

• Active ingredient: somatropin (recombinant human growth hormone).
• Strength: 4 i.u. per vial (equivalent to 1.6 mg somatropin).
• Form: lyophilized powder for solution for injection in vial.
• Route of administration: subcutaneous or intramuscular injection, as directed by physician.
• Pack size: number of vials per pack is not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.); refer to the product packaging for exact count.
• Manufacturer: SEDICO.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.