PRODUCTS

Medicine


Amotalex

Product Category: Prescription Drugs 




Basic Information



Ingredients

5.625 mg sodium polydeoxyribonucleotide in 1 vial (3 mL)


Appearance

Vial injection filled with colorless transparent liquid in a colorless transparent container


Classification Number

490 (Other drugs for the function of tissue cells)


Effects

Treatment and tissue repair of wounds caused by skin grafts


 Usage/Dosage

Administer 1 vial per day by intramuscular or subcutaneous injection.


Storage

Sealed container, room temperature (1~30℃) storage


Mechanism of action

1. It binds to the A2 receptor and has an anti-inflammatory effect.

2. It induces angiogenesis by promoting VEGF secretion.

3. Regenerate damaged tissues by activating growth factors (FGF, IGF, EGF) secretion.

4. It activates the salvage pathway, resulting in faster wound healing and tissue regeneration.



Detail Information


Precautions

1. Do not administer to the following patients

    Patients with hypersensitivity to the main ingredient of this drug and ingredients contained in this drug


2. General caution

     If a hypersensitivity reaction occurs with the administration of this drug, discontinue administration and take appropriate measures.


3. Interaction

    The interaction of this drug with other drugs has not been studied.


4. Results of post-marketing research in Korea

    As a result of a post-marketing survey conducted on 609 patients for 6 years for reexamination in Korea, the incidence rate of adverse            events was 0.99% (6/609 patients, total 7) regardless of causal relationship. 

    One case each was reported: itchy rash, oropharyngeal pain, vomiting, leukopenia, abdominal pain, diarrhea, and nausea. There were no 

    serious adverse events or unexpected adverse events.


※ Re-examination adverse case analysis and evaluation result

Domestic reexamination adverse events and voluntary side effects report data for this drug are reviewed at the end of reexamination and adverse event report data for all drugs approved for domestic marketing.

As a result of the pooled evaluation, there were no statistically significantly higher reported adverse events compared to those reported for all other medicinal products.