GROWJECT S.C. INJECTION 12MG (SOMATROPIN)

GROWJECT S.C. INJECTION 12MG (SOMATROPIN)

GROWJECT S.C. INJECTION 12MG (SOMATROPIN), known in Japan as グロウジェクト皮下注12mg, is a prescription recombinant human growth hormone medicine manufactured by JCR Pharmaceuticals Co., Ltd.

Each cartridge contains 12mg of somatropin in 1.5mL of clear, colorless solution for subcutaneous injection. This is the total cartridge content, not the dose for a single injection.

Product Information

• Product Name: GROWJECT S.C. INJECTION 12MG (SOMATROPIN)
• Japanese Name: グロウジェクト皮下注12mg
• Brand: GROWJECT
• Chinese Name: GROWJECT 重組人生長激素皮下注射液 12mg／1.5mL
• Active Ingredient: Somatropin (genetical recombination)
• Medicine Type: Recombinant human growth hormone
• Prescription Status in Japan: Prescription-only medicine
• Strength: 12mg per cartridge
• Volume: 1.5mL per cartridge
• Dosage Form: Solution for injection in a cartridge
• Appearance: Clear, colorless solution
• Administration: Subcutaneous injection
• Manufacturer: JCR Pharmaceuticals Co., Ltd.
• Package: One 1.5mL cartridge

What Is GROWJECT?

GROWJECT contains somatropin, a recombinant human growth hormone. Treatment requires a qualifying diagnosis and assessment against the applicable prescribing criteria.

Short stature alone does not establish eligibility. Anti-aging, bodybuilding and athletic performance enhancement are not listed Japanese approved indications.

Key Features

• Prescription recombinant human growth hormone medicine
• Contains somatropin 12mg in each 1.5mL cartridge
• Liquid formulation that does not require reconstitution
• For prescribed subcutaneous administration
• Requires a compatible dedicated injection device
• Requires refrigerated storage and ongoing medical monitoring

Approved Uses in Japan

• Growth hormone deficiency-related short stature without epiphyseal closure
• Short stature associated with Turner syndrome without epiphyseal closure
• Severe adult growth hormone deficiency
• Small-for-gestational-age (SGA) short stature without epiphyseal closure
• Short stature associated with SHOX deficiency without epiphyseal closure

Each indication has specific diagnostic and prescribing requirements. Japanese approval does not establish approval or eligibility in another jurisdiction.

Dosage and Administration

The prescriber determines the dose according to the diagnosis, body weight, clinical response and laboratory results. Do not interpret the 12mg cartridge strength as a single-dose instruction.

Use the dedicated injection device according to its instructions. Home administration requires authorization from the treating clinician and appropriate training.

• Use only as prescribed.
• Do not independently start treatment or change the prescribed dose.
• Never share cartridges or injection devices.
• Follow the clinician’s instructions for injection-site rotation.
• Do not use a damaged or expired cartridge.

Refrigerated Storage

• Store refrigerated at 2–8°C.
• Do not freeze.
• After use, promptly return the cartridge to the refrigerator and protect it from light.
• Use within 35 days after starting use.
• Do not use medicine that has frozen.
• Check the supplied packaging for the expiry date.
• Ask a pharmacist for advice if storage conditions have not been maintained.

Important Safety Information

This medicine must not be used by patients with malignancy or by individuals who are pregnant or may be pregnant.

Diabetes, impaired glucose tolerance and other medical conditions require assessment by the treating clinician. Tell the clinician about your medical history and all medicines you use.

Possible adverse effects include fluid retention, joint pain, injection-site reactions and changes in glucose metabolism. This is not a complete list. Regular medical monitoring is required during treatment.

Package Contents

• GROWJECT S.C. INJECTION 12MG
• Somatropin 12mg in 1.5mL
• One cartridge

Do not assume that an injection device, needles or other accessories are included. Confirm the actual supplied package before purchase or dispensing.

Important Disclaimer

This product information is for general reference only. It does not replace the official prescribing information, individualized medical advice, pharmacist counseling or injection-device training.

This page does not establish authorization for sale, importation, advertising or use in any jurisdiction. Supply and use must comply with applicable local requirements.