ETC(Ethical Drugs)

Instructions and Precautions for Use of Melsmon Injection

[Content of Raw Materials] In 1 ampoule (2mL):

• Active Ingredient: Human Placenta Extract (Star Gyules)... 2mL (containing 100mg of soluble substances)

[Description] A brown ampoule containing a clear, pale yellow liquid.

[Indications/Effects] Improvement of symptoms caused by menopausal disorders.

[Usage/Dosage] As human placenta extract, administer 2mL per session, three times a week for two weeks (total of 6 sessions) via subcutaneous injection.

[Precautions for Use]

1. Warnings

   1. When cutting the ampoule, minimize the risk of glass fragments, which may cause side effects. Use with caution, especially for children and the elderly.
   2. This medicine contains human placenta-derived ingredients. While preventive measures against infection have been implemented during the collection of placenta and in the manufacturing process, complete elimination of the risk of infection transmission is not guaranteed. Therefore, its use should be limited to cases where the therapeutic benefits outweigh the risk of disease transmission.

2. Patients not to be administered

   1. Patients with hypersensitivity to this medicine or other drugs
   2. Patients suspected of having constitutional diseases
   3. Patients with moderate complications other than heart, liver, and kidney
   4. Patients with organic heart disease

3. Patients to be administered with caution Patients with allergic constitutions

4. Adverse reactions

   1. Shock: Discontinue administration and provide appropriate treatment if symptoms of shock occur.
   2. Hypersensitivity reactions: Chills, erythema, fever, rash, etc., discontinue administration in such cases.
   3. Injection site reactions: Pain, erythema, etc., may occur.
   4. Others: Breast tenderness, occasional development of gynecomastia, discontinue administration in such cases.

5. General precautions

   1. When considering the use of this medicine, explain to the patient that although safety measures are taken to prevent infection during manufacturing, there remains a risk of infection transmission due to the use of human placenta as a raw material. Efforts should be made to ensure patient understanding of these risks.

6. Application precautions In subcutaneous injections, take care to avoid affecting tissues and nerves:

   1. Administer carefully to avoid nerve pathways at the injection site.
   2. When administering repeated injections, alternate sides to avoid injecting the same area.
   3. If severe pain or blood reflux occurs upon needle insertion, immediately withdraw the needle and inject in a different area.
   4. Use for subcutaneous injections only.

[Packing Unit] 1 ampoule (2mL) x 50 ampoules/box

[Storage Method] Seal in a container and store at room temperature (1~30℃).

[Shelf Life] 24 months from the date of manufacture ※ If purchasing expired, deteriorated, spoiled, contaminated, or damaged medicine, please exchange it through a pharmaceutical sales agent.