Medication info

Greenplast Q Prefilled Syringe Kit

Prescription medication외용
Ingredient · strength
Human Fibrinogen Concentrate Solution›95mgAprotinin›Strength being verifiedThrombin›Strength being verified
Manufacturer / importer
(주)녹십자
Appearance
A pair of prefilled syringes with a white to pale yellow freeze-dried solution inside, sealed at both ends.
Packaging
1 kit / box [kit (2 milliliters)], 1 kit / box [kit (4 milliliters)]
Approval status
Active

MFDS item code 201112325 · Approved 2011.12.30 · Insurance code 643604880,643605491

Summary

Main use
Assists in surgeries (tissue adhesion, suturing, local hemostasis)
Who uses it
Adults
Adult use
Dosage is determined according to the area of the wound surface to be treated or the defect area to be filled. It is typically used according to the size of the surface area requiring adhesion. Up to 8 cm² use 2 mL kit Up to 16 cm² use 4 mL kit Usage 1) Thawing (1) Remove the drug from the freezer and allow it to sit at room temperature (30 - 50 minutes). However, for emergency surgeries, heat the syringe in a sterilized water bath below 37 °C. (2)

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Assists in surgeries (tissue adhesion, suturing, local hemostasis)

  • Tissue adhesion
  • suturing
  • local hemostasis
View approved original text

This medication is used when it is difficult to control bleeding with existing treatment methods or when those methods are insufficient. It is particularly useful as an adjunct in various surgical fields including general surgery, cardiac surgery, thoracic surgery, pediatric surgery, neurosurgery, orthopedics, plastic surgery, trauma, obstetrics and gynecology, urology, ENT, dental and oral surgery, and ophthalmology. Its primary functions are tissue adhesion, suturing, and facilitating local hemostasis. This supports healing at the surgical site and enhances safety and efficacy, making it an important adjunct in several surgical procedures.

How to use

Adult use

Dosage is determined according to the area of the wound surface to be treated or the defect area to be filled. It is typically used according to the size of the surface area requiring adhesion. Up to 8 cm² use 2 mL kit Up to 16 cm² use 4 mL kit Usage 1) Thawing (1) Remove the drug from the freezer and allow it to sit at room temperature (30 - 50 minutes). However, for emergency surgeries, heat the syringe in a sterilized water bath below 37 °C. (2)

Precautions

Since this drug is derived from human plasma, it cannot be guaranteed that there are no viruses or infectious agents that can be transmitted through blood. Therefore, it is recommended that patients with hemophilia or those with weakened immune systems receive vaccinations such as the hepatitis A vaccine, and that doctors regularly check for signs of infection. Additionally, it is crucial to provide patients with sufficient information about the risk of infection when using this drug and to use it minimally only when absolutely necessary. This drug should not be used in patients with severe bleeding, those allergic to the bovine protein contained in the drug, or in cases where it is injected directly into blood vessels. Patients with hemolytic anemia or severe anemia and those with weakened immune systems should use this medication with caution due to the potential risk of infection. In rare cases, individuals with a history of repeated use of this drug or who are allergic to bovine protein may experience allergic reactions such as shortness of breath, skin rash, and hypotension, and if symptoms occur, use should be discontinued immediately and treatment sought. Adverse reactions such as fever, vomiting, and headaches may occur due to the thrombin component in this medication. As it is difficult to fully remove viruses like Parvovirus B19, post-administration monitoring is essential, especially for pregnant women or those with weakened immune systems, as serious symptoms may arise. Care should be taken to prevent the drug from contacting areas other than the treatment site, and additional hemostatic measures must be taken in cases of severe bleeding. Caution is required during endoscopic procedures as local injection of this drug may cause tissue damage or hematoma and, rarely, pancreatitis. Iodine, hydrogen peroxide, and alcohol may reduce the efficacy of this drug, and interactions may occur due to calcium content when administered intravenously to patients taking cardiac glycosides. The safety of this drug during pregnancy is not firmly established, and it may affect the fetus, so it should only be used when deemed absolutely necessary. This drug is intended for local use only and should not be administered intravenously or mixed with other medications. It is best to use the drug immediately after thawing, store it at room temperature for no more than 72 hours, and ensure it is not refrozen. When stored, maintain a frozen state at below -20 degrees Celsius.

Side effects and when to seek care immediately

Serious side effects

Urticaria, dyspnea, anaphylactic reactions (including severe anaphylactic shock)

Mild side effects

  • Fever
  • vomiting
  • headache
  • flushing
  • hypotension
  • bronchospasm

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a sealed container to protect it from exposure to air and should be kept frozen at temperatures below -20 degrees Celsius. This will help maintain the drug’s effectiveness and safety.

Appearance and packaging

Appearance

A pair of prefilled syringes with a white to pale yellow freeze-dried solution inside, sealed at both ends.

Package unit

1 kit / box [kit (2 milliliters)], 1 kit / box [kit (4 milliliters)]

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.